OKEDI 75 mg Порошок И Раствор Для Инъекционной Суспензии Пролонгированного Действия

Содержание инструкции

1. OKEDI 75 mg powder and solvent for prolonged-release injectable suspension
   1. What is OKEDI and what is it used for
   2. What you need to know before using OKEDI
   3. How to use OKEDI
   4. Possible side effects
   5. How to store OKEDI
   6. Contents of the pack and other information
2. OKEDI 75 mg powder and solvent for prolonged-release injectable suspension
   1. CHECK THE CONTENTS
   2. 1 Inspect the solvent syringe
   3. 2 Loosen the powder in the syringe
   4. 2 Connect the syringes
   5. MIX THE CONTENTS
   6. 2 Disconnect the syringes
   7. 3 Attach the sterile needle with safety protection
   8. 4 Remove excess air
   9. 2 Disposal of the medicine
3. OKEDI 100 mg powder and solvent for prolonged-release injectable suspension
   1. What is OKEDI and what is it used for
   2. What you need to know before using OKEDI
   3. How to use OKEDI
   4. Possible side effects
   5. How to store OKEDI
   6. Contents of the pack and other information
4. OKEDI 100 mg powder and solvent for prolonged-release injectable suspension
   1. CHECK THE CONTENTS
   2. 1 Inspect the solvent syringe
   3. 2 Loosen the powder in the syringe
   4. 2 Connect the syringes
   5. MIX THE CONTENTS
   6. 2 Disconnect the syringes
   7. 3 Attach the sterile needle with the safety shield
   8. 4 Remove excess air
   9. 2 Disposal of the medicine

OKEDI 75 mg powder and solvent for prolonged-release injectable suspension

risperidone

Read this leaflet carefully before you start to use this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

• 1. What OKEDI is and what it is used for
• 2. What you need to know before you use OKEDI
• 3. How to use OKEDI
• 4. Possible side effects
• 5. How to store OKEDI
• 6. Contents of the pack and other information

1. What is OKEDI and what is it used for

OKEDI contains the active substance risperidone, which belongs to the group of medicines called
“antipsychotics”.
OKEDI is used in adult patients for the treatment of schizophrenia, a disease in which the patient
may see, hear and experience things that do not exist, believe things that are not true and feel
unusually suspicious or confused.
OKEDI is indicated for use in patients in whom the tolerability and efficacy of treatment with
oral risperidone (e.g., tablets) have been demonstrated.
OKEDI can help to relieve the symptoms of the disease and prevent their recurrence.

2. What you need to know before using OKEDI

Do not use OKEDI

• if you are allergic (hypersensitive) to risperidone or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking OKEDI if:

• you have a heart problem. For example, you have an irregular heartbeat, are predisposed to low blood pressure or are using medicines for blood pressure. OKEDI can cause low blood pressure. It may be necessary to adjust your dose;
• you are aware of factors that could predispose you to a stroke, such as high blood pressure, cardiovascular disorder or problems with the blood vessels in the brain;
• you have experienced involuntary movements of the tongue, mouth or face;
• you have had an illness whose symptoms include high temperature, muscle rigidity, sweating or reduced level of consciousness (also known as neuroleptic malignant syndrome);
• you suffer from Parkinson's disease;
• you suffer from dementia;
• you know that you have had low levels of white blood cells in the past (whether or not they were caused by other medicines);
• you are diabetic;
• you suffer from epilepsy;
• you are a man and have had a prolonged or painful erection;
• you have problems controlling body temperature or feel an excessive sensation of heat;
• you have kidney problems;
• you have liver problems;
• you have an unusually high level of the hormone prolactin in your blood or suffer from a tumor that potentially depends on prolactin;
• you or someone in your family has a history of blood clots, as antipsychotics have been associated with such formations.

If you have doubts about whether any of the cases listed here apply to your
situation, talk to your doctor or pharmacist before using oral risperidone or OKEDI.

During treatment
In very rare cases, a dangerously
low number of a certain type of white blood cells necessary to fight infections in the blood has been observed in patients taking risperidone.
Therefore, your doctor may check your white blood cell count before and during treatment.
Even if you have previously tolerated oral risperidone, allergic reactions may occur rarely after the administration of OKEDI injections. Contact your doctor immediately if you experience a rash, swelling of the throat, itching or breathing problems, as these may be signs of a serious allergic reaction.
OKEDI can cause weight gain. Significant weight gain can have negative
effects on your health. Your doctor should measure your body weight regularly.
Diabetes mellitus or worsening of pre-existing diabetes mellitus has been observed in
patients taking OKEDI. Therefore, your doctor should check for signs of high
blood sugar levels. Blood glucose should be monitored regularly in
patients with pre-existing diabetes mellitus.
OKEDI generally increases levels of a hormone called "prolactin", which can cause adverse
effects such as menstrual disorders, fertility problems in women, and increased breast volume in
men (see section 4, Possible side effects). If these side effects occur, it is recommended to evaluate prolactin levels in the blood.
During cataract surgery, for clouding of the lens, problems may occur that could cause damage to the eye. If you are planning to undergo such
surgery, be sure to tell the ophthalmologist that you are taking this medicine.

Children and adolescents
This medicine should not be given to children and adolescents under the age of 18 years.

Other medicines and OKEDI
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

It is particularly important that you tell your doctor or pharmacist if you are taking any
of the following medicines

• Medicines that act on the brain, such as those with a calming effect (benzodiazepines), pain medicines (opioids) or allergy medicines (some antihistamines), as OKEDI can enhance their sedative effect.
• Medicines that can change the electrical activity of the heart, such as medicines for malaria, heart rhythm problems, allergies (antihistamines), some antidepressants or other medicines for mental problems.
• Medicines that slow down the heartbeat.
• Medicines that lower potassium levels in the blood (such as some diuretics).
• Medicines for the treatment of high blood pressure. OKEDI can lower blood pressure.
• Medicines for Parkinson's disease (such as levodopa).
• Medicines that increase the activity of the central nervous system (stimulants, such as methylphenidate).
• Medicines to stimulate the secretion of water (diuretics) used for heart problems or for swelling of some parts of the body due to excessive fluid accumulation (such as furosemide or chlorothiazide). OKEDI taken alone or with furosemide may increase the risk of stroke or death in elderly patients with dementia.

The following medicines can reduce the effect of risperidone

• Rifampicin (a medicine to treat some infections)
• Carbamazepine, phenytoin (medicines for epilepsy)
• Phenobarbital

If you start or stop taking these medicines, you may need to change the dose of
risperidone.

The following medicines can increase the effect of risperidone

• Quinidine (used in certain types of heart disease)
• Antidepressants (such as paroxetine, fluoxetine, tricyclic antidepressants)
• Medicines known as beta-blockers (used to treat high blood pressure)
• Phenothiazines (such as medicines used to treat psychosis or as sedatives)
• Cimetidine, ranitidine (stomach acid blockers)
• Itraconazole and ketoconazole (medicines for the treatment of fungal infections)
• Some medicines used in the treatment of HIV/AIDS, such as ritonavir.
• Verapamil, a medicine used to treat high blood pressure and/or irregular heartbeat
• Sertraline and fluvoxamine, medicines used to treat depression and other psychiatric disorders

If you start or stop taking these medicines, you may need to change the dose
of risperidone.
If you have doubts about whether any of the cases listed here apply to your
situation, talk to your doctor or pharmacist before using OKEDI.

OKEDI with food, drinks and alcohol
You should avoid alcoholic beverages while using OKEDI.

Pregnancy, breastfeeding and fertility

• If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. The doctor will decide whether you can use it.
• The following symptoms may occur in newborns of mothers who have used risperidone in the last three months of pregnancy: tremor, muscle rigidity and/or weakness, drowsiness, agitation, breathing problems and difficulty feeding. If your baby experiences any of these symptoms, you may need to contact your doctor.
• OKEDI can increase levels of a hormone called "prolactin", which can affect fertility (see section 4, Possible side effects).

Driving and using machines
Dizziness, fatigue and vision problems may occur during treatment with
OKEDI. Do not drive or use tools or machinery without talking to your doctor first.

3. How to use OKEDI

OKEDI will be administered as an intramuscular injection in the upper arm or buttock every 28 days by a healthcare professional. The injections must be alternated between the right and left side.
The recommended dose is 75 mg every 28 days, but a higher dose of 100 mg every 28 days may be necessary. The doctor will decide the appropriate dose of OKEDI for you.
If you are currently being treated with antipsychotics other than risperidone, but have taken risperidone in the past, you must start taking oral risperidone at least 6 days before starting treatment with OKEDI.
If you have never taken any form of risperidone, you must start taking oral risperidone at least 14 days before starting treatment with OKEDI. The duration of the oral risperidone treatment period will be determined by the doctor.

If you have kidney problems
Treatment with OKEDI is not recommended in patients with moderate to severe impaired renal function.

If you are given more OKEDI than you should

• Contact your doctor immediately.
• In case of overdose, you may experience drowsiness or fatigue, or exhibit abnormal body movements, problems standing or walking, dizziness due to low blood pressure, or abnormal heartbeats or seizures.

If you stop using OKEDI
You will lose the effects of the medicine. Do not stop using this medicine unless your doctor tells you to, as your symptoms may return.
It is important that you attend all visits that involve the administration of injections of this medicine every 28 days. If you cannot attend the visit, you must inform your doctor immediately to schedule another date.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Seek medical attention or go to the nearest emergency room immediately if you experience the
following uncommon side effect (may affect up to 1 in 100 people):

• tardive dyskinesia (jerky or twitching movements that you cannot control in the face, tongue or other parts of the body);

Seek medical attention or go to the nearest emergency room immediately if you experience
any of the following rare side effects (may affect up to 1 in 1,000 people):

• blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness), which can travel to the lungs through the blood vessels causing chest pain and difficulty breathing;
• fever, muscle stiffness, sweating or a reduced level of consciousness (a condition called "neuroleptic malignant syndrome");
• if you are a man and experience a prolonged or painful erection, a condition called priapism;
• a severe allergic reaction, characterised by fever, swelling of the mouth, face, lips or tongue, difficulty breathing, itching, rash or a drop in blood pressure (anaphylactic reaction or angioedema). Even if you have previously tolerated oral risperidone, allergic reactions can rarely occur after injections of OKEDI;
• dark red or brown urine or a noticeable decrease in urine output together with muscle weakness or problems moving your arms and legs. These could be signs of rhabdomyolysis (rapid muscle breakdown);
• weakness or mental confusion, fever, chills or mouth ulcers. These could be signs of a very low number of granulocytes (a type of white blood cell that helps fight infections).

Other side effects may also occur:

Very common side effects (may affect more than 1 in 10 people):

• Difficulty falling asleep or staying asleep
• Parkinsonism: movement disorders that can include slow or impaired movements, a feeling of stiffness or tension in the muscles and, sometimes, even a feeling that movement "blocks" and then restarts. Other signs include a slow and shuffling gait, resting tremor, increased salivation and/or drooling, and loss of facial expression
• Headache

Common side effects (may affect up to 1 in 10 people):

• Pneumonia (lung infection), bronchitis (infection of the main airways of the lungs), sinus infection, urinary tract infection, ear infection, influenza, flu-like symptoms, sore throat, cough, nasal congestion, fever, eye infection or redness of the eyes
• Increased levels of a hormone called "prolactin", detected in a blood test. Symptoms of high prolactin are rare and may include, in men, enlargement of the breasts, difficulty getting or maintaining an erection, decreased sexual desire. In women they may include milk production from the breasts, sexual dysfunction, missed menstrual periods, lack of ovulation, fertility problems
• Weight gain, increased or decreased appetite
• Sleep disorder, irritability, depression, anxiety, feeling sleepy or less alert
• Dystonia (involuntary muscle contractions that cause slow, repetitive movements or abnormal postures), dyskinesia (another medical condition that affects muscle movements, including repetitive, jerky or twisting movements or muscle contraction)
• Tremor, muscle spasms, bone or muscle pain, back pain, joint pain, falls
• Blurred vision
• Urinary incontinence (involuntary loss of urine)
• Rapid heartbeat, high blood pressure, difficulty breathing
• Abdominal pain, abdominal discomfort, vomiting, nausea, dizziness, constipation, diarrhoea, indigestion, dry mouth, toothache
• Rash, skin redness, injection site reaction (including discomfort, pain, redness or swelling), swelling of the body, arms or legs, chest pain, lack of energy and strength, fatigue, pain

Uncommon side effects (may affect up to 1 in 100 people):

• Bladder infection, tonsillitis, fungal nail infection, infection of the deep layers of the skin, viral infection, skin inflammation caused by mites
• Decreased or increased white blood cells in the blood, decreased platelets (blood cells that help stop bleeding), anaemia or decreased hematocrit (decreased red blood cells), increased creatine phosphokinase enzyme in the blood, increased liver enzymes in the blood
• Low blood pressure, decreased blood pressure after standing up, flushing, cerebral ischemia (insufficient blood flow to the brain)
• Diabetes, high blood sugar levels, excessive thirst, increased cholesterol in the blood, weight loss, anorexia, high levels of triglycerides (a fat) in the blood
• Mania (euphoric mood), confusion, decreased sexual desire, nervousness, nightmares
• Fainting, seizures (convulsions), feeling dizzy, tinnitus, ear pain
• Irresistible urge to move parts of the body, balance disorder, abnormal coordination, poor attention, speech problems, loss or abnormality of the sense of taste, reduced skin sensation to pain and touch, tingling, prickling or numbness of the skin
• Irregular and often fast heartbeat, slow heartbeat, abnormal electrocardiogram (a test that measures the electrical activity of the heartbeat), palpitations (feeling of hammering or fluttering in the chest), disruption of conduction between the upper and lower parts of the heart
• Congestion of the airways, wheezing (raspy/whistling sound during breathing), nosebleed
• Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain, abnormal gait, thirst, feeling unwell, chest tightness or general discomfort, feeling “down”
• Infection or irritation of the stomach or intestines, faecal incontinence, difficulty swallowing, excessive gas emission from the body, frequent need to urinate, inability to urinate, pain when urinating
• Absence of menstruation or other problems regarding the menstrual cycle, milk production from the breasts, sexual dysfunction, breast pain or discomfort, vaginal discharge, erectile dysfunction, ejaculation disorder, increased breast volume in men
• Urticaria, thickening of the skin, skin disease, intense skin itching, hair loss, eczema, dry skin, altered skin colour, acne, seborrheic dermatitis (red, scaly, greasy, itchy and inflamed skin), skin lesion
• Excessive sensitivity of the eyes to light, dry eyes, increased tearing
• Allergic reaction, chills

Rare side effects (may affect up to 1 in 1,000 people):

• Infection
• Unusual secretion of a hormone that controls urine volume, dangerously high intake of water, excess sugars in the urine, low blood sugar levels, increased insulin in the blood (a hormone that controls blood sugar levels)
• Lack of responsiveness to stimuli, catatonia (immobility and lack of reactions while awake), low level of consciousness, sleepwalking, eating disorder related to sleep, difficulty breathing during sleep (sleep apnea), rapid and shallow breathing, lung infection caused by inhaling food into the airways, pulmonary congestion, breathing disorder, voice disorder, crackles in the lung, lack of emotion, inability to reach orgasm
• Problems with blood vessels in the brain, coma caused by uncontrolled diabetes, involuntary head tremor
• Glaucoma (increased pressure inside the eye), problems with eye movement, rolling eye, crusting/inflammation of the eyelid margin, eye problems during cataract surgery
• Inflammation of the pancreas, bowel obstruction
• Swollen tongue, chapped lips, dandruff, jaundice (yellowing of the skin and eyes), hardening of the skin
• Enlargement of the breasts, breast congestion (hard, swollen, painful breasts due to excessive milk production)
• Decreased body temperature, feeling of cold in the arms and legs
• Withdrawal symptoms from substance abuse (also in newborns)

Very rare side effects (may affect up to 1 in 10,000 people):

• Life-threatening complications of uncontrolled diabetes
• Lack of muscle movement in the intestine causing an obstruction

Side effects with unknown frequency: frequency cannot be estimated from available data:

• Severe or life-threatening rash with blisters and peeling of the skin that can start inside and around the mouth, nose, eyes and genitals and spread to other areas of the body (Stevens-Johnson syndrome / toxic epidermal necrolysis).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system detailed in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store OKEDI

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package, on the aluminium
blisters and on the syringe labels after Scad or EXP. The expiry date refers to the last day of that
month.
Store at a temperature below 30 °C. Store in the original packaging to protect the medicine from
moisture.
Use OKEDI immediately after reconstitution.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What OKEDI contains
The active ingredient is risperidone.
Only the powder syringe contains the active ingredient. After reconstitution, the amount of risperidone
administered is 75 mg.
The other ingredients are:
Prefilled powder syringe: copolymer (D,L-lactic acid and glycolic acid).
Prefilled solvent syringe: dimethyl sulfoxide.

Description of the appearance of OKEDI and contents of the pack
Each pack of the OKEDI powder and solvent kit for prolonged-release injectable suspension
contains:

• one aluminum pouch with a prefilled syringe containing powder (this powder contains the active ingredient risperidone) and one desiccant pouch of silica gel. The powder is from white to off-white, not aggregated;
• one aluminum pouch with a prefilled syringe containing solvent and one desiccant pouch of silica gel. The prefilled solvent syringe contains a clear solution and has a RED finger flange;
• one sterile needle for i.m. injection 2 inches (0.90 x 51 mm [20G]) with safety guard used for administration into the gluteus;
• one sterile needle for i.m. injection 1 inch (0.80 x 25 mm [21G]) with safety guard used for administration into the deltoid.

Marketing Authorisation Holder and Manufacturer
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid.
Spain
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Espagne/Spanje
Tel: +34 91 375 62 30

Lietuva
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Ispanija
Tel: +34 91 375 62 30

България
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Испания
Teл.: +34 91 375 62 30

Luxembourg/Luxemburg
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Espagne/Spanien
Tel: +34 91 375 62 30

Česká republika
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Španělsko
Tel: +34 91 375 62 30

Magyarország
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Spanyolország
Tel: +34 91 375 62 30

Danmark
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Spanien
Tlf: +34 91 375 62 30

Malta
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Spanja
Tel: +34 91 375 62 30

Deutschland
Rovi GmbH
Rudolf-Diesel-Ring 6
83607 Holzkirchen
Tel: +49 8024 4782955

Nederland
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Spanje
Tel: +34 91 375 62 30

Eesti
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Hispaania
Tel: +34 91 375 62 30

Norge
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Spania
Tlf: +34 91 375 62 30

Ελλάδα
BIANEΞ Α.Ε.
Οδός Βαρυμπόμπης 8,
14671 Ν. Ερυθραία, Κηφισιά
Tηλ. 210 8009111

Österreich
Rovi GmbH
Rudolf-Diesel-Ring 6
83607 Holzkirchen
Deutschland
Tel: +43 664 1340471

España
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Tel: +34 91 375 62 30

Polska
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Hiszpania
Tel: +34 91 375 62 30

France
ROVI
24, Rue Du Drac
38180 Seyssins
Tél: +33 (0)4 76 968 969

Portugal
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Espanha
Tel: +34 91 375 62 30

Hrvatska
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Španija
Tel: +34 91 375 62 30

Ireland
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Spain
Tel: +34 91 375 62 30

România
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Spania
Tel: +34 91 375 62 30

Slovenija
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Španija
Tel: +34 91 375 62 30

Ísland
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Spánn
Sími: +34 91 375 62 30

Slovenská republika
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Španielsko
Tel: +34 91 375 62 30

Italia
Rovi Biotech, S.R.L.
Viale Achille Papa, 30
20149 Milano
Tel: +39 02 366 877 10

Suomi/Finland
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Espanja/Spanien
Puh/Tel: +34 91 375 62 30

Κύπρος
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Ισπανία
Τηλ: +34 91 375 62 30

Sverige
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Spanien
Tel: +34 91 375 62 30

Latvija
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Spānija
Tel: +34 91 375 62 30

United Kingdom (Northern Ireland)
Rovi Biotech Limited
Davis House 4th Floor Suite 425
Robert Street Croydon CR0 1QQ - UK
Tel: + 44 (0) 203 642 06 77
The following information is intended exclusively for healthcare professionals:

INSTRUCTIONS FOR HEALTHCARE PROFESSIONALS

OKEDI 75 mg powder and solvent for prolonged-release injectable suspension

Important information
OKEDI requires particular attention to each step of these Instructions for Use to ensure
correct administration.

Use the supplied components
The components supplied with the kit are specifically designed for use with
OKEDI.
OKEDI must be reconstituted exclusively with the solvent provided in the kit packaging.

Do not replaceANY component of the kit packaging.
Administer the dose immediately after reconstitution. For intramuscular use only after
reconstitution.

Administer the correct dose
To ensure the release of the intended dose of OKEDI, it is necessary to administer the entire contents
of the reconstituted syringe.

Single-use device

1. CHECK THE CONTENTS

On a clean surface, open the sachets and discard the desiccant sachets.
Each package of the OKEDI kit contains:

• one aluminum foil sachet with a prefilled syringe of OKEDI with a WHITE plunger rod and a WHITE finger flange. The syringe is marked with ;
• one aluminum foil sachet with a prefilled syringe of SOLVENT for OKEDI with a TRANSPARENT plunger rod and a RED finger flange. The syringe is marked with ;
• two administration needles (21G, 1 inch for the deltoid [green cap] and 20G, 2 inches for the gluteus [yellow cap]).

Dispose of the kit if any component is damaged.
If you notice the presence of foreign particles and/or changes in physical appearance, do not
administer OKEDI.

1.1 Inspect the solvent syringe

ENSURE that the contents of the SOLVENT syringe flow normally like a liquid.

The solvent freezes below 19 °C.
If it is frozen or partially frozen, thaw it with the heat of your hands or leave it at room
temperature until it returns completely to a liquid state before proceeding.

1.2 Loosen the powder in the syringe

TAP the OKEDI syringe to loosen any potentially compacted powder near the
cap.

2. CONNECT THE SYRINGES

2.1 Remove the cap from the syringes in a vertical position

Hold both syringes in a vertical position to avoid product leakage.

PULL the cap off the Solvent syringe to remove it.

ROTATE and PULL the cap off the Powder syringe to remove it.

2.2 Connect the syringes

Grasp the solvent syringe S equipped with a colored finger flange and position it ON TOP of the powder syringe R, or tilt it slightly during connection.
ROTATE the syringes together until a slight resistance is felt.

Ensure that the Powder R syringe is in a vertical position to avoid loss of the
product.

3. MIX THE CONTENTS

STOP AND READ THIS PARAGRAPH BEFORE STARTING, OTHERWISE THE
RECONSTITUTION OF THE MEDICINE MAY NOT BE PERFORMED CORRECTLY.

• PUSH FIRMLYthe contents of the Solvent into the Powder syringe.
• DO NOT WAIT for the powder to become wet, but start mixing the contents IMMEDIATELYby pushing the plungers QUICKLY in alternating rhythm for 100 pushes (2 pushes persecond, approximately 1 minute)
• For correct mixing, MAKE SURE that the medicine passes from one syringe to the other: themedicine is viscous, therefore strong pressure must be appliedto the plungers.

Mixby performing at least 100 pushesalternating

Make sure that the medicine passes from one syringe to the other
When the medicine is mixed correctly, it will appear as a uniform suspension of
color from whitish to yellowish and a dense consistency.

Once reconstitution has taken place, immediately proceed with preparing the syringe
for administration in order to avoid loss of homogeneity.

4. PREPARE THE INJECTION SYRINGE

4.1 Transfer the medicine

Apply downward pressure on the plunger rod Rand transfer all the contents into the
syringe Sequipped with a colored finger flange.
Make sure you have transferred all the contents.

4.2 Disconnect the syringes

After completely transferring the medicine, separate the two syringes by rotating them in a counterclockwise direction.
OKEDI must be administered immediately to avoid loss of homogeneity.

4.3 Attach the sterile needle with safety protection

Choose the correct needle:

• Deltoid: 21G, 1 inch for the deltoid (green cap).
• Gluteus: 20G, 2 inches for the gluteus (yellow cap).

Attach the needle with a rotating clockwise motion. Do not overtighten.

4.4 Remove excess air

Remove the needle protection and push to expel excess air (only large bubbles) from the
syringe cylinder.

DO NOT expel any drops of medicine
If you notice medicine on the tip of the needle, slightly retract the plunger to prevent it from
leaking out.

5. ADMINISTER AND DISPOSE

5.1 Inject the medicine

Insert the needle completely into the muscle. DO NOT INJECT BY OTHER ROUTES.

THICK MEDICINE, INJECT SLOWLY AND STEADILY. MAKE SURE TO
INJECT IT COMPLETELY.
Considering the viscosity of the medicine, the injection requires more time than usual.
Wait a few seconds before removing the needle.
Avoid accidental injection into a blood vessel.

5.2 Disposal of the medicine

Cover the needle by pressing the appropriate protection with a finger or against a flat surface, then
immediately dispose of it in a secure sharps and puncture-resistant container.

OKEDI 100 mg powder and solvent for prolonged-release injectable suspension

risperidone

Read this leaflet carefully before you start to take this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

• 1. What OKEDI is and what it is used for
• 2. What you need to know before you use OKEDI
• 3. How to use OKEDI
• 4. Possible side effects
• 5. How to store OKEDI
• 6. Contents of the pack and other information

1. What is OKEDI and what is it used for

OKEDI contains the active ingredient risperidone, which belongs to the group of medicines called
“antipsychotics”.
OKEDI is used in adult patients for the treatment of schizophrenia, a disease in which the patient
may see, hear and experience things that do not exist, believe things that are not true and feel
unusually suspicious or confused.
OKEDI is indicated for use in patients in whom the tolerability and efficacy of treatment with
oral risperidone (e.g., tablets) have been demonstrated.
OKEDI can help relieve the symptoms of the disease and prevent their recurrence.

2. What you need to know before using OKEDI

Do not use OKEDI

• if you are allergic (hypersensitive) to risperidone or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking OKEDI if:

• you have a heart problem. For example, you have an irregular heartbeat, are predisposed to low blood pressure or are using medicines for blood pressure. OKEDI can cause low blood pressure. Your dose may need to be adjusted;
• you are aware of factors that could predispose you to a stroke, such as high blood pressure, cardiovascular disorder or problems with blood vessels in the brain;
• you have experienced involuntary movements of the tongue, mouth or face;
• you have had an illness whose symptoms include high temperature, muscle rigidity, sweating or reduced level of consciousness (also known as neuroleptic malignant syndrome);
• you suffer from Parkinson's disease;
• you suffer from dementia;
• you know you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines);
• you are diabetic;
• you suffer from epilepsy;
• you are a man and have had a prolonged or painful erection;
• you have problems controlling body temperature or feel an excessive sensation of heat;
• you have kidney problems;
• you have liver problems;
• you have an unusually high level of the hormone prolactin in your blood or suffer from a tumor that may be prolactin-dependent;
• you or someone else in your family has a history of blood clots, as antipsychotics have been associated with such formations.

If you have doubts about whether any of the cases listed above applies to your
situation, talk to your doctor or pharmacist before using oral risperidone or OKEDI.

During treatment
In very rare cases, a dangerously
low number of a certain type of white blood cells necessary to fight infections in the blood has been observed in patients taking risperidone.
Therefore, your doctor may check the number of your white blood cells before and during treatment.
Even if you have previously tolerated oral risperidone, allergic reactions may occur rarely after the administration of OKEDI injections. Contact your doctor immediately if you experience rash, swelling of the throat, itching or breathing problems, as these may be signs of a serious allergic reaction.
OKEDI can cause weight gain. Significant weight gain can have negative
effects on your health. Your doctor should measure your body weight regularly.
Diabetes mellitus or worsening of pre-existing diabetes mellitus has been observed in
patients taking OKEDI. Therefore, your doctor should check for signs of high
blood sugar levels. Blood glucose should be monitored regularly in
patients with pre-existing diabetes mellitus.
OKEDI generally increases the levels of a hormone called "prolactin", which can cause adverse
effects such as menstrual disorders, fertility problems in women, increased breast volume in
men (see section 4, Possible side effects). If these side effects occur, it is recommended to evaluate prolactin levels in the blood.
During cataract surgery, for clouding of the lens, problems may arise that could cause damage to the eye. If you are planning to undergo such
surgery, be sure to tell your ophthalmologist that you are taking this medicine.

Children and adolescents
This medicine should not be given to children and adolescents under the age of 18 years.

Other medicines and OKEDI
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

It is particularly important that you tell your doctor or pharmacist if you are taking any of the following medicines

• Medicines that act on the brain, such as those with a calming effect (benzodiazepines), pain medicines (opioids) or allergy medicines (some antihistamines), as OKEDI can enhance their sedative effect.
• Medicines that can change the electrical activity of the heart, such as medicines for malaria, heart rhythm problems, allergies (antihistamines), some antidepressants or other medicines for mental problems.
• Medicines that slow down the heartbeat.
• Medicines that lower potassium levels in the blood (such as some diuretics).
• Medicines for the treatment of high blood pressure. OKEDI can lower blood pressure.
• Medicines for Parkinson's disease (such as levodopa).
• Medicines that increase the activity of the central nervous system (stimulants, such as methylphenidate).
• Medicines to stimulate water secretion (diuretics) used for heart problems or swelling of some parts of the body due to excessive fluid accumulation (such as furosemide or chlorothiazide). OKEDI taken alone or with furosemide can increase the risk of stroke or death in elderly patients with dementia.

The following medicines can reduce the effect of risperidone

• Rifampicin (a medicine to treat some infections)
• Carbamazepine, phenytoin (medicines for epilepsy)
• Phenobarbital

If you start or stop taking these medicines, you may need to change the dose
of risperidone.

The following medicines can increase the effect of risperidone

• Quinidine (used in certain types of heart disease)
• Antidepressants (such as paroxetine, fluoxetine, tricyclic antidepressants)
• Medicines known as beta-blockers (used to treat high blood pressure)
• Phenothiazines (such as medicines used to treat psychosis or as sedatives)
• Cimetidine, ranitidine (stomach acid blockers)
• Itraconazole and ketoconazole (medicines for the treatment of fungal infections)
• Some medicines used in the treatment of HIV/AIDS, such as ritonavir.
• Verapamil, a medicine used to treat high blood pressure and/or abnormal heart rhythm
• Sertraline and fluvoxamine, medicines used to treat depression and other psychiatric disorders

If you start or stop taking these medicines, you may need to change the dose
of risperidone.
If you have doubts about whether any of the cases listed above applies to your
situation, talk to your doctor or pharmacist before using OKEDI.

OKEDI with food, drinks and alcohol
You should avoid alcoholic beverages while using OKEDI.

Pregnancy, breastfeeding and fertility

• If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. The doctor will decide if you can use it.
• The following symptoms may occur in newborns of mothers who have used risperidone in the last three months of pregnancy: tremor, muscle rigidity and/or weakness, drowsiness, agitation, breathing problems and difficulty feeding. If your baby experiences any of these symptoms, you may need to contact your doctor.
• OKEDI can increase the levels of a hormone called "prolactin", which can affect fertility (see section 4, Possible side effects).

Driving and using machines
Dizziness, fatigue and vision problems can occur during treatment with
OKEDI. Do not drive or use tools or machines without talking to your doctor first.

3. How to use OKEDI

OKEDI will be administered as an intramuscular injection in the upper arm or buttock every 28 days by a healthcare professional. The injections must be alternated between the right and left side.
The recommended dose is 75 mg every 28 days, but a higher dose of 100 mg every 28 days may be necessary. Your doctor will decide the appropriate dose of OKEDI for you.
If you are currently being treated with antipsychotics other than risperidone, but have taken risperidone in the past, you will need to start taking risperidone at least 6 days before starting treatment with OKEDI.
If you have never taken any form of risperidone, you should start taking oral risperidone at least 14 days before starting treatment with OKEDI. The duration of the oral risperidone treatment period will be determined by your doctor.

If you have kidney problems
Treatment with OKEDI is not recommended in patients with moderate to severe impaired renal function.

If you are given more OKEDI than you should

• Contact your doctor immediately.
• In case of overdose, you may experience drowsiness or fatigue, or develop abnormal body movements, problems standing or walking, dizziness due to low blood pressure, or abnormal heartbeats or seizures.

If you stop using OKEDI
You will lose the effects of the medicine. Do not stop using this medicine unless your doctor tells you to, as your symptoms may return.
It is important that you attend all appointments for the administration of injections of this medicine every 28 days. If you cannot attend the appointment, you must inform your doctor immediately to schedule another date.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Seek medical attention or go to the nearest emergency room immediately if you experience the
following uncommon side effect (may affect up to 1 in 100 people):

• tardive dyskinesia (jerky or twitching movements that you cannot control in the face, tongue or other parts of the body);

Seek medical attention or go to the nearest emergency room immediately if you experience
any of the following rare side effects (may affect up to 1 in 1,000 people):

• blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness), which can travel to the lungs through the blood vessels causing chest pain and difficulty breathing;
• fever, muscle stiffness, sweating or a reduced level of consciousness (a condition called "neuroleptic malignant syndrome");
• if you are a man and experience a prolonged or painful erection, a condition called priapism;
• a severe allergic reaction, characterized by fever, swelling of the mouth, face, lips or tongue, difficulty breathing, itching, rash or low blood pressure (anaphylactic reaction or angioedema). Even if you have previously tolerated oral risperidone, allergic reactions can rarely occur after injections of OKEDI;
• dark red or brown urine or a significant decrease in urine output along with muscle weakness or problems moving your arms and legs. These could be signs of rhabdomyolysis (rapid muscle breakdown);
• weakness or mental confusion, fever, chills or mouth ulcers. These could be signs of a very low number of granulocytes (a type of white blood cell that helps fight infections).

Other side effects may also occur:

Very common side effects (may affect more than 1 in 10 people):

• Difficulty falling asleep or staying asleep
• Parkinsonism: movement disorders that can include slow or impaired movements, a feeling of stiffness or tension in the muscles, and sometimes even a feeling that movement "blocks" and then restarts. Other signs include a slow and shuffling gait, resting tremor, increased salivation and/or drooling, and loss of facial expression
• Headache

Common side effects (may affect up to 1 in 10 people):

• Pneumonia (lung infection), bronchitis (infection of the main airways of the lungs), sinus infection, urinary tract infection, ear infection, influenza, flu-like symptoms, sore throat, cough, nasal congestion, fever, eye infection or redness of the eyes
• Increased levels of a hormone called "prolactin", detected in a blood test. Symptoms of high prolactin occur rarely and may include, in men, enlargement of the breasts, difficulty having or maintaining an erection, decreased sexual desire. In women, they may include milk production from the breasts, sexual disorders, missed menstrual periods, lack of ovulation, fertility problems
• Weight gain, increased or decreased appetite
• Sleep disorder, irritability, depression, anxiety, feeling sleepy or less alert
• Dystonia (involuntary muscle contractions causing slow, repetitive movements or abnormal postures), dyskinesia (another medical condition that affects muscle movements, including repetitive, jerky or twisting movements or muscle contraction)
• Tremor, muscle spasms, bone or muscle pain, back pain, joint pain, falls
• Blurred vision
• Urinary incontinence (involuntary loss of urine)
• Rapid heartbeat, high blood pressure, shortness of breath
• Abdominal pain, abdominal discomfort, vomiting, nausea, dizziness, constipation, diarrhea, indigestion, dry mouth, toothache
• Rash, skin redness, injection site reaction (including discomfort, pain, redness or swelling), swelling of the body, arms or legs, chest pain, lack of energy and strength, fatigue, pain

Uncommon side effects (may affect up to 1 in 100 people):

• Bladder infection, tonsillitis, fungal nail infection, infection of the deep layers of the skin, viral infection, skin inflammation caused by mites
• Decreased or increased white blood cells in the blood, decreased platelets (blood cells that help stop bleeding), anemia or decreased hematocrit (decreased red blood cells), increased creatine phosphokinase enzyme in the blood, increased liver enzymes in the blood
• Low blood pressure, decreased blood pressure after standing up, flushing, cerebral ischemia (insufficient blood flow to the brain)
• Diabetes, high blood sugar levels, excessive thirst, increased cholesterol in the blood, weight loss, anorexia, high levels of triglycerides (a fat) in the blood
• Mania (euphoric mood), confusion, decreased sexual desire, nervousness, nightmares
• Fainting, seizures (convulsions), feeling dizzy, tinnitus, ear pain
• Irresistible urge to move parts of the body, balance disorder, abnormal coordination, poor attention, speech problems, loss or abnormality of the sense of taste, reduced sensation of the skin to pain and touch, tingling, prickling or numbness of the skin
• Irregular and often fast heartbeat, slow heartbeat, abnormal electrocardiogram (test that measures the electrical activity of the heartbeat), palpitations (feeling of pounding or fluttering in the chest), disruption of conduction between the upper and lower parts of the heart
• Congestion of the airways, wheezing (raspy/whistling sound during breathing), nosebleeds
• Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain, abnormal gait, thirst, feeling unwell, general discomfort, feeling “down”
• Infection or irritation of the stomach or intestines, fecal incontinence, difficulty swallowing, excessive gas from the body, frequent urination, inability to urinate, pain when urinating
• Absence of menstruation or other problems regarding the menstrual cycle, milk production from the breasts, sexual dysfunction, breast pain or discomfort, vaginal discharge, erectile dysfunction, ejaculation disorder, increased breast volume in men
• Urticaria, thickening of the skin, skin disease, intense skin itching, hair loss, dry skin, altered skin color, acne, seborrheic dermatitis (red, scaly, oily, itchy, inflamed skin), skin lesion
• Excessive sensitivity of the eyes to light, dry eyes, increased tearing
• Allergic reaction, chills

Rare side effects (may affect up to 1 in 1,000 people):

• Infection
• Unusual secretion of a hormone that controls urine volume, dangerously high intake of water, excess sugars in the urine, low blood sugar levels, increased insulin in the blood (a hormone that controls blood sugar levels
• Lack of responsiveness to stimuli, catatonia (immobility and lack of reactions while awake), low level of consciousness, sleepwalking, sleep-related eating disorder, difficulty breathing during sleep (sleep apnea), rapid and shallow breathing, lung infection caused by inhalation of food into the airways, pulmonary congestion, breathing disorder, speech disorder, crepitations in the lung, lack of emotion, inability to reach orgasm
• Problems with blood vessels in the brain, coma caused by uncontrolled diabetes, involuntary head tremor
• Glaucoma (increased pressure inside the eye), problems with eye movement, roving eye, crusting/inflammation of the eyelid margin, problems with the eye during cataract surgery
• Inflammation of the pancreas, intestinal obstruction
• Swollen tongue, chapped lips, dandruff, jaundice (yellowing of the skin and eyes), hardening of the skin
• Enlargement of the breasts, breast congestion (hard, swollen, painful breasts due to excessive milk production)
• Decreased body temperature, feeling cold in the arms and legs
• Substance abuse withdrawal symptoms (also in newborns)

Very rare side effects (may affect up to 1 in 10,000 people):

• Life-threatening complications of uncontrolled diabetes
• Lack of muscle movement in the intestine causing an obstruction

Side effects with unknown frequency: frequency cannot be estimated from available data:

• Severe or life-threatening skin rash with blisters and peeling of the skin that can start inside and around the mouth, nose, eyes and genitals and spread to other areas of the body (Stevens-Johnson syndrome / toxic epidermal necrolysis).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor. You can also report side effects directly through the national reporting system detailed in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store OKEDI

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package, on the aluminium
sachets and on the syringe labels after Scad or EXP. The expiry date refers to the last day of that
month.
Store at a temperature below 30 °C. Store in the original package to protect the medicine from
moisture.
Use OKEDI immediately after reconstitution.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What OKEDI contains
The active ingredient is risperidone.
Only the powder syringe contains the active ingredient. After reconstitution, the amount of risperidone
administered is 100 mg.
The other ingredients are:
Prefilled powder syringe: copolymer (D,L-lactic acid and glycolic acid).
Prefilled solvent syringe: dimethyl sulfoxide.

Description of the appearance of OKEDI and contents of the pack
Each pack of the OKEDI powder and solvent kit for prolonged-release injectable suspension
contains:

• one aluminum pouch with a prefilled syringe containing powder (this powder contains the active ingredient risperidone) and one desiccant pouch of silica gel. The powder is from white to off-white, not aggregated;
• one aluminum pouch with a prefilled syringe containing solvent and one desiccant pouch of silica gel. The prefilled solvent syringe contains a clear solution and has a BLUE finger flange;
• one sterile needle for i.m. injection 2 inches (0.90 x 51 mm [20G]) with safety shield used for administration into the gluteus;
• one sterile needle for i.m. injection 1 inch (0.80 x 25 mm [21G]) with safety shield used for administration into the deltoid

Marketing Authorisation Holder and Manufacturer
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid.
Spain
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Espagne/Spanje
Tel: +34 91 375 62 30

Lietuva
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Ispanija
Tel: +34 91 375 62 30

България
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Испания
Teл.: +34 91 375 62 30

Luxembourg/Luxemburg
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Espagne/Spanien
Tel: +34 91 375 62 30

Česká republika
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Španělsko
Tel: +34 91 375 62 30

Magyarország
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Spanyolország
Tel: +34 91 375 62 30

Danmark
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Spanien
Tlf: +34 91 375 62 30

Malta
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Spanja
Tel: +34 91 375 62 30

Deutschland
Rovi GmbH
Rudolf-Diesel-Ring 6
83607 Holzkirchen
Tel: +49 8024 4782955

Nederland
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Spanje
Tel: +34 91 375 62 30

Eesti
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Hispaania
Tel: +34 91 375 62 30

Norge
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Spania
Tlf: +34 91 375 62 30

Ελλάδα
BIANEΞ Α.Ε.
Οδός Βαρυμπόμπης 8,
14671 Ν. Ερυθραία, Κηφισιά
Tηλ. 210 8009111

Österreich
Rovi GmbH
Rudolf-Diesel-Ring 6
83607 Holzkirchen
Deutschland
Tel: +43 664 1340471

España
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Tel: +34 91 375 62 30

Polska
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Hiszpania
Tel: +34 91 375 62 30

France
ROVI
24, Rue Du Drac
38180 Seyssins
Tél: +33 (0)4 76 968 969

Portugal
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Espanha
Tel: +34 91 375 62 30

Hrvatska
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Španija
Tel: +34 91 375 62 30

Ireland
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Spain
Tel: +34 91 375 62 30

România
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Spania
Tel: +34 91 375 62 30

Slovenija
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Španija
Tel: +34 91 375 62 30

Ísland
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Spánn
Sími: +34 91 375 62 30

Slovenská republika
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Španielsko
Tel: +34 91 375 62 30

Italia
Rovi Biotech, S.R.L.
Viale Achille Papa, 30
20149 Milano
Tel: +39 02 366 877 10

Suomi/Finland
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Espanja/Spanien
Puh/Tel: +34 91 375 62 30

Κύπρος
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Ισπανία
Τηλ: +34 91 375 62 30

Sverige
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Spanien
Tel: +34 91 375 62 30

Latvija
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Spānija
Tel: +34 91 375 62 30

United Kingdom (Northern Ireland)
Rovi Biotech Limited
Davis House 4th Floor Suite 425
Robert Street Croydon CR0 1QQ - UK
Tel: + 44 (0) 203 642 06 77
The following information is intended for healthcare professionals only:

INSTRUCTIONS FOR HEALTHCARE PROFESSIONALS

OKEDI 100 mg powder and solvent for prolonged-release injectable suspension

Important information
OKEDI requires particular attention to each step of these Instructions for Use to ensure
correct administration.

Use the supplied components
The components supplied with the kit are specifically designed for use with
OKEDI.
OKEDI must be reconstituted exclusively with the solvent provided in the kit packaging.

Do not replaceANY component of the kit packaging.
Administer the dose immediately after reconstitution. For intramuscular use only after
reconstitution.

Administer the correct dose
To ensure the release of the intended dose of OKEDI, it is necessary to administer the entire contents
of the reconstituted syringe.

Single-use device

1. CHECK THE CONTENTS

On a clean surface, open the sachets and discard the desiccant sachets.
Each package of the OKEDI kit contains:

• one aluminum foil sachet with a prefilled syringe of OKEDI with a WHITE plunger rod and a WHITE finger flange. The syringe is marked with ;
• one aluminum foil sachet with a prefilled syringe of SOLVENT for OKEDI with a TRANSPARENT plunger rod and a BLUE finger flange. The syringe is marked with ;
• two administration needles (21G, 1 inch for the deltoid [green cap] and 20G, 2 inches for the gluteus [yellow cap]).

Dispose of the kit if any component is damaged.
If you notice the presence of foreign particles and/or changes in physical appearance, do not
administer OKEDI.

1.1 Inspect the solvent syringe

ENSURE that the contents of the SOLVENT syringe flow normally like a liquid.

The solvent freezes below 19 °C.
If it is frozen or partially frozen, thaw it with the heat of your hands or leave it at room
temperature until it returns to a completely liquid state before proceeding.

1.2 Loosen the powder in the syringe

TAP the OKEDI syringe to loosen any potentially compacted powder near the
cap.

2. CONNECT THE SYRINGES

2.1 Remove the cap from the syringes in a vertical position

Hold both syringes in a vertical position to avoid product leakage.

PULL the cap off the Solvent syringe.

ROTATE and PULL the cap off the Powder syringe.

2.2 Connect the syringes

Grasp the solvent syringe S equipped with a colored finger flange and position it ABOVE the powder syringe R, or tilt it slightly during connection.
ROTATE the syringes together until a slight resistance is felt.

Ensure that the Powder R syringe is in a vertical position to prevent loss of the
product.

3. MIX THE CONTENTS

STOP AND READ THIS PARAGRAPH BEFORE STARTING, OTHERWISE THE
RECONSTITUTION OF THE MEDICINE MAY NOT BE PERFORMED CORRECTLY.

• PUSH FIRMLYthe contents of the Solvent into the Powder syringe.
• DO NOT WAIT for the powder to become moist, but immediately start mixing the contents by pushing the plungers QUICKLY in an alternating rhythm for 100 pushes (2 pushes persecond, approximately 1 minute)
• For correct mixing, MAKE SURE that the medicine passes from one syringe to the other: themedicine is viscous, therefore strong pressure must be appliedto the plungers.

Mixby performing at least 100 alternating pushes

Make sure that the medicine passes from one syringe to the other
When the medicine is correctly mixed, it will appear as a uniform suspension of
color from whitish to yellowish and a dense consistency.

Once reconstitution has taken place, immediately proceed with preparing the syringe
for administration in order to avoid loss of homogeneity.

4. PREPARE THE INJECTION SYRINGE

4.1 Transfer the medicine

Apply downward pressure on the plunger rod Rand transfer all the contents into the
syringe Sequipped with a colored finger flange.

Make sure you have transferred all the contents.

4.2 Disconnect the syringes

After completely transferring the medicine, separate the two syringes by rotating them in a counterclockwise direction.
OKEDI must be administered immediately to avoid loss of homogeneity.

4.3 Attach the sterile needle with the safety shield

Choose the correct needle:

• Deltoid: 21G, 1 inch for the deltoid (green cap).
• Gluteus: 20G, 2 inches for the gluteus (yellow cap).

Attach the needle with a clockwise rotating motion. Do not overtighten.

4.4 Remove excess air

Remove the needle protection and push to expel excess air (only large bubbles) from the
syringe cylinder.

DO NOT expel any drops of medicine
If you notice the presence of medicine on the needle tip, slightly retract the plunger to prevent it from
leaking.

5. ADMINISTER AND DISPOSE

5.1 Inject the medicine

Insert the needle completely into the muscle. DO NOT INJECT BY OTHER ROUTES.

DENSE MEDICINE, INJECT SLOWLY AND STEADILY. MAKE SURE TO
INJECT IT COMPLETELY.
Considering the viscosity of the medicine, the injection requires more time than usual.
Wait a few seconds before removing the needle.
Avoid accidental injection into a blood vessel.

5.2 Disposal of the medicine

Cover the needle by pressing the appropriate protection with a finger or against a flat surface, then
immediately dispose of it in a secure container for sharp and piercing waste.