TREVICTA 175 mg Injectable Suspension

Зміст інструкції

1. TREVICTA 175 mg prolonged-release injectable suspension, 263 mg prolonged-release injectable suspension, 350 mg prolonged-release injectable suspension, 525 mg prolonged-release injectable suspension
   1. What is TREVICTA and what it is used for
   2. What you need to know before you use TREVICTA
   3. How to use TREVICTA
   4. Possible side effects
   5. How to store TREVICTA
   6. Contents of the pack and other information

TREVICTA 175 mg prolonged-release injectable suspension, 263 mg prolonged-release injectable suspension, 350 mg prolonged-release injectable suspension, 525 mg prolonged-release injectable suspension

paliperidone

Read this leaflet carefully before you start using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is TREVICTA and what it is used for

TREVICTA contains the active substance paliperidone, which belongs to the class of medicines
antipsychotics and is used as maintenance treatment for the symptoms of schizophrenia in
adult patients.
If you have responded well to treatment with paliperidone palmitate injection given once a
month, your doctor may start treatment with TREVICTA.
Schizophrenia is an illness with “positive” and “negative” symptoms. Positive symptoms refer to an excess of
symptoms that are not normally present. For example, a person with schizophrenia may hear
voices or see things that do not actually exist (called hallucinations), believe things that are not true
(called delusions) or be unusually suspicious of others. Negative symptoms refer to a lack of
behaviours or sensations that are normally present. For example,
a person with schizophrenia may tend to isolate themselves and may not react
emotionally or may have difficulty speaking clearly and logically. People with
this illness may also feel depressed, anxious, guilty or tense.
TREVICTA can help to relieve the symptoms of your illness and prevent them from recurring

2. What you need to know before you use TREVICTA

Do not use TREVICTA

• if you are allergic to paliperidone or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to another antipsychotic medicine, including risperidone.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using TREVICTA.
This medicine has not been studied in elderly patients with dementia. However, elderly patients
with dementia, treated with other similar medicines, may have an increased risk of stroke
or death (see section 4).
All medicines have side effects and some of the side effects of this medicine
may worsen the symptoms of other medical conditions. For this reason, it is important that you
discuss with your doctor any of the following conditions, which may potentially worsen
during treatment with this medicine:

• if you have Parkinson’s disease
• if you have ever been diagnosed with an illness whose symptoms include high temperature and muscle rigidity (also known as Neuroleptic Malignant Syndrome)
• if you have ever had involuntary abnormal movements of the face, tongue or other parts of the body (Tardive Dyskinesia)
• if you are aware of having had low levels of white blood cells in the past (which may or may not have been caused by other medicines)
• if you are diabetic or predisposed to diabetes
• if you have been diagnosed with breast cancer or a tumour of the pituitary gland in the brain
• if you have a heart condition or are taking treatment for a heart condition that tends to lower your blood pressure
• if you have low blood pressure when you stand up or go from lying down to sitting suddenly
• if you suffer from epilepsy
• if you have kidney problems
• if you have liver problems
• if you have a prolonged and/or painful erection
• if you have difficulty controlling your internal body temperature or conditions of excessive heat
• if you have an abnormally high level of the hormone prolactin in your blood or if you have a possible prolactin-dependent tumour
• if you or someone in your family has a history of blood clot formation (thrombosis), as antipsychotics have been associated with blood clot formation.

If you have any of these conditions, talk to your doctor so that they can assess whether it is
necessary to adjust the dose or monitor you closely for a certain period.
Because a dangerously low number of a certain type of white blood cells needed to fight infections in the
blood has been observed in patients taking this medicine, your doctor may check your white blood cell count.
Even if you have previously tolerated oral paliperidone or oral risperidone, allergic reactions rarely occur
after receiving injections of TREVICTA. Contact your doctor immediately
if you develop a rash, swelling of the throat, itching or breathing problems as these may
be signs of a serious allergic reaction.
This medicine can cause an increase in body weight. Significant weight gain
can negatively affect your health. Your doctor should weigh you regularly.
Because diabetes mellitus or a worsening of pre-existing diabetes mellitus has been observed in patients taking this medicine, your doctor should check for high
blood sugar levels. In patients with pre-existing diabetes mellitus, blood glucose levels should be monitored regularly.
Since this medicine may reduce the urge to vomit, there is a possibility that
it may mask the body's normal response to the ingestion of toxic substances or other medical conditions.
During an eye operation for cataracts (clouding of the lens), the pupil (the black circle in the
centre of your eye) may not increase in size as needed. In addition, the iris (the coloured part
of the eye) may become floppy during surgery and this can cause damage
to the eye. If you are planning to have an eye operation, be sure to inform
your ophthalmologist that you are taking this medicine.

Children and adolescents
Do not use this medicine in children and adolescents under the age of 18 years. It is not known if it is
safe and effective in these patients.

Other medicines and TREVICTA
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Taking this medicine with carbamazepine (antiepileptic and mood stabilizer) may
require adjustment of the dose of this medicine.
Because this medicine acts mainly on the brain, the use of other medicines that act
on the brain may cause an amplification of side effects such as drowsiness or other effects on the
brain, as do other psychiatric drugs, opioids, antihistamines and sleep disorder medications.
Because this medicine can lower blood pressure, be careful when this
medicine is used with other medicines that reduce blood pressure.
This medicine may reduce the effect of medicines used for Parkinson’s disease and
restless legs syndrome (e.g. levodopa).
This medicine can cause an abnormality in the electrocardiogram (ECG), characterized by a
longer period for the progression of an electrical impulse through a certain part of the
heart known as “QT interval prolongation”. Other medicines that have this effect
include some medicines used to treat heart rhythm or to treat infections, and other
antipsychotics.
If you have a history of seizures, this medicine may increase the possibility of having them. Other
medicines that have this effect include some medicines used to treat
depression or infections, and other antipsychotics.
TREVICTA should be used with caution with medicines that increase the activity of the central nervous
system (psychostimulants such as methylphenidate).

TREVICTA with alcohol
Alcohol should be avoided.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine. You should not use this
medicine during pregnancy unless you have already discussed this with your doctor. The following
symptoms may occur in newborns of mothers who have used paliperidone in the last trimester
(last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation,
breathing problems, and difficulty feeding. If the baby develops any of these
symptoms, contact your doctor.
This medicine can pass from the mother to the newborn through breast milk and may harm the baby.
Therefore, you should not breastfeed while using this medicine.

Driving and using machines
Dizziness, extreme fatigue and
vision problems (see section 4) may occur during treatment with this medicine. This should be taken into account in cases where complete alertness is required, e.g. when driving a car or using machinery.

TREVICTA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially "sodium-free".

3. How to use TREVICTA

This medicine is administered by your doctor or another healthcare professional. Your doctor will
tell you when you need to have the next injection. It is important not to miss the scheduled dose.
If you are unable to attend your appointment with the doctor, contact them immediately to schedule a
new appointment as soon as possible.
You will receive an injection of TREVICTA in the upper arm or buttock once every
3 months.
Depending on the symptoms, your doctor may increase or decrease the amount of medicine you receive at
the time of the next scheduled injection.
Patients with kidney problems
If you have mild kidney problems, your doctor will determine the appropriate dose of TREVICTA based on the dose
of paliperidone palmitate injectable with monthly administration that you were receiving. If you have moderate or severe
kidney problems, this medicine should not be used.
Elderly
Your doctor will determine the appropriate dose for you of this medicine if your kidney function is
reduced.

If you take more TREVICTA than you should
This medicine will be administered under medical supervision; it is therefore unlikely that
you will be given an excess dose.
Patients who have received an overdose of paliperidone may experience the following
symptoms: drowsiness or sedation, increased heart rate, decreased blood
pressure, electrocardiogram abnormalities (tracing of the heart's electrical activity), or
slow or abnormal movements of the face, body, arms or legs.

If you stop using TREVICTA
If you stop receiving your injections, the symptoms of schizophrenia may worsen. You should not
stop using this medicine unless it is established by your doctor.
If you have any further questions about taking 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.

Tell your doctor immediately if:

• you feel you have blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which can move along the blood vessels to

the lungs, causing chest pain and difficulty breathing. If you notice any of these
symptoms, consult your doctor immediately

• you suffer from dementia and notice a sudden change in your mental state or sudden weakness or numbness in the face, arms or legs, especially on one side, or if your speech is unintelligible, even for a short period. These may be signs of a stroke
• you have a fever, muscle rigidity, sweating or reduced level of consciousness (a condition called “Neuroleptic Malignant Syndrome”). Immediate medical treatment may be necessary.
• you are a man and have a prolonged or painful erection. This condition is called priapism. Immediate medical treatment may be necessary
• you experience involuntary rhythmic movements of the tongue, mouth and face. It may be necessary to discontinue paliperidone
• you experience a severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, skin rash and sometimes a drop in blood pressure (corresponding to an ‘anaphylactic reaction’). Even if you have previously tolerated oral risperidone or oral paliperidone, allergic reactions rarely occur after receiving paliperidone injections
• you are planning to undergo eye surgery, make sure to inform the ophthalmologist that you are taking this medicine. During eye surgery for cataracts, the iris (the colored part of the eye) may become floppy during surgery (“iris flaccidity syndrome”) and may cause damage to the eye
• you are aware of having a dangerously low number of a certain type of white blood cells in your blood needed to fight infections

The following side effects may occur.

Very common: may affect more than 1 in 10 people

• difficulty falling asleep or staying asleep

Common: may affect up to 1 in 10 people

• common cold symptoms, urinary tract infection, feeling as if you have the flu
• TREVICTA may increase the levels of a hormone called “prolactin” found in a blood test (which may or may not cause symptoms). When symptoms due to high prolactin levels occur, these may include: (in men) breast enlargement, difficulty achieving or maintaining an erection or other sexual dysfunctions; (in women) breast discomfort, milk production from the breasts, absence of menstrual periods or other problems with the menstrual cycle
• high blood sugar levels, weight gain, weight loss, decreased appetite
• irritability, depression, anxiety
• feeling restless
• parkinsonism: this condition may include slow or altered movements, a feeling of stiffness or tension in the muscles (making movements jerky) and sometimes also a feeling of “freezing” of movement that stops and then restarts. Other signs of Parkinsonism include slow walking with shuffling feet, resting tremor, increased salivation and/or drooling, and a loss of facial expression
• restlessness, feeling sleepy or drowsy
• dystonia: this is a condition involving slow or prolonged involuntary muscle contractions. Although it can involve any part of the body (resulting in an abnormal posture), dystonia often affects the muscles of the face, including abnormal movements of the eyes, mouth, tongue or jaw
• dizziness
• dyskinesia: this is a condition involving involuntary muscle movements and may include repetitive, jerky, contorted or contracting movements
• tremor
• headache
• fast heartbeat
• high blood pressure
• cough, nasal congestion
• abdominal pain, vomiting, nausea, constipation, diarrhea, indigestion, toothache
• increased liver transaminases in the blood
• bone, muscle or joint pain, back pain
• missed menstrual periods
• fever, weakness, fatigue (tiredness)
• a reaction at the injection site, including itching, pain or swelling.

Uncommon: may affect up to 1 in 100 people

• pneumonia, chest infection (bronchitis), upper respiratory tract infection, sinusitis, bladder infection, ear infection, tonsillitis, fungal nail infection, skin infection, subcutaneous abscess
• decreased white blood cell count, decreased number of a certain type of white blood cells that help protect the body from infections, anemia
• allergic reaction
• diabetes or worsening of diabetes, increased insulin in the blood (a hormone that controls blood sugar levels)
• increased appetite
• loss of appetite leading to malnutrition and low body weight
• high levels of triglycerides (fats), increased cholesterol in the blood
• sleep disorders, elevated mood (mania), decreased sexual drive, nervousness, nightmares
• tardive dyskinesia (jerky or twitching movements that you cannot control in the face, tongue or other parts of the body). Contact your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth and face. It may be necessary to discontinue this medicine
• fainting, incessant need to move parts of the body, dizziness when standing up, attention disorders, speech problems, loss or abnormal sense of taste, reduced sensitivity of the skin to pain and touch, tingling, prickling or numbness of the skin
• blurred vision, eye infection or conjunctivitis, dry eyes
• sensation of spinning (vertigo), ringing in the ears, ear pain
• interruption of conduction between the upper and lower parts of the heart, abnormal electrical conduction of the heart, prolongation of the QT interval of the heart, fast heartbeat when standing up, slowed heartbeat, abnormal electrical tracing of the heart (electrocardiogram or ECG), a sensation of a fast or pounding heartbeat (palpitations)
• low blood pressure, decrease in blood pressure when standing up (as a result, some people taking this medicine may feel faint, dizzy or may faint when getting up or sitting down quickly)
• shortness of breath, sore throat, nosebleed
• abdominal discomfort, stomach or intestinal infection, difficulty swallowing, dry mouth, excessive gas or air
• increased GGT in the blood (a liver enzyme called gamma-glutamyl transferase), increased liver enzymes in the blood
• urticaria, itching, skin rash, hair loss, eczema, dry skin, reddened skin, acne
• increased CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released when there is muscle damage, muscle spasms, joint stiffness, muscle weakness, urinary incontinence, frequent urination, painful urination
• erectile dysfunction, ejaculation disorders, loss of menstrual periods or other problems with the menstrual cycle (women), development of breasts in men, sexual dysfunction, breast pain, milk production from the breasts
• swelling of the face, mouth, eyes or lips, swelling of the body, arms or legs
• increased body temperature
• a change in the way you walk
• chest pain, chest discomfort, feeling unwell
• hardening of the skin
• falls

Rare: may affect up to 1 in 1,000 people

• eye infection
• skin inflammation caused by mites, scaling and itching of the scalp or skin, increased eosinophils (a type of white blood cells) in your blood
• decreased platelets (blood cells that help stop bleeding)
• inappropriate secretion of a hormone that controls urine volume
• sugar in the urine
• complications of uncontrolled diabetes leading to life-threatening conditions
• low blood sugar
• excessive intake of water
• absence of movement or responses when awake (catatonia)
• confusion
• head tremor
• sleepwalking
• lack of emotions
• inability to reach orgasm
• neuroleptic malignant syndrome (confusion, reduced or loss of consciousness, high fever and severe muscle rigidity), cerebrovascular problems including sudden loss of blood supply to the brain (stroke or “mini” stroke), lack of response to stimuli, loss of consciousness, low level of consciousness, seizures (convulsions), balance disorders
• abnormal coordination
• glaucoma (increased pressure inside the eye)
• problems with eye movement, eye rotation, hypersensitivity of the eyes to light, increased tearing, redness of the eyes
• atrial fibrillation (an abnormal heart rhythm), irregular heartbeat
• blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness in the legs). If you notice any of these symptoms, consult your doctor immediately
• blood clots in the lungs that can cause chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical attention
• hot flashes
• disturbed breathing during sleep (sleep apnea)
• congestion of the lungs, congestion of the airways, wheezing
• crepitus in the lungs
• inflammation of the pancreas, swelling of the tongue, fecal incontinence, very hard stools
• bowel obstruction
• chapped lips
• drug-related skin rash, severe and 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)
• severe allergic reaction with swelling that can affect the throat causing difficulty breathing
• change in skin color
• abnormal posture
• newborns of mothers who have taken TREVICTA during pregnancy may experience side effects of the medicine and/or withdrawal symptoms, such as irritability, slow or prolonged muscle contractions, tremor, drowsiness, breathing or feeding problems
• very low body temperature, chills, feeling thirsty
• withdrawal symptoms from the medicine
• pus accumulation caused by infection at the injection site, deep skin infection, cyst at the injection site, bruising at the injection site

Not known: frequency cannot be estimated from available data

• dangerous decrease in a certain type of white blood cells in the blood that help protect the body from infections
• severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, lack of breath, itching, skin rash and sometimes a drop in blood pressure
• dangerously excessive intake of water
• sleep-related eating disorder
• coma caused by uncontrolled diabetes
• fast and shallow breathing, pneumonia caused by aspiration of food, speech disorders
• decreased oxygen in parts of your body (due to reduced blood flow)
• lack of intestinal muscle movement causing blockage
• yellowing of the skin and eyes (jaundice)
• severe and 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)
• severe allergic reaction with swelling that can affect the throat causing difficulty breathing
• change in skin color
• abnormal posture
• newborns of mothers who have taken TREVICTA during pregnancy may experience side effects of the medicine and/or withdrawal symptoms, such as irritability, slow or prolonged muscle contractions, tremor, drowsiness, breathing or feeding problems
• decreased body temperature
• death of skin cells at the injection site, ulcer at the injection site.

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

5. How to store TREVICTA

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 carton.
The expiry date refers to the last day of the month.
This medicine does not require any particular storage conditions.
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 TREVICTA contains
The active ingredient is paliperidone.
Each pre-filled syringe of TREVICTA 175 mg contains 273 mg of paliperidone palmitate in 0.88
mL.
Each pre-filled syringe of TREVICTA 263 mg contains 410 mg of paliperidone palmitate in 1.32
mL.
Each pre-filled syringe of TREVICTA 350 mg contains 546 mg of paliperidone palmitate in 1.75
mL.
Each pre-filled syringe of TREVICTA 525 mg contains 819 mg of paliperidone palmitate in 2.63
mL.
The other ingredients are:
Polysorbate 20
Polyethylene glycol 4000
Citric acid monohydrate
Sodium dihydrogen phosphate monohydrate
Sodium hydroxide (for pH adjustment)
Water for injections

Description of TREVICTA’s appearance and contents of the pack
TREVICTA is a prolonged-release injectable suspension of white to off-white colour contained
in a pre-filled syringe, which the doctor or nurse will shake vigorously to suspend
the medicine well before injecting it.
Each pack contains 1 pre-filled syringe and 2 needles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: +32 14 64 94 11

Lietuva
UAB “JOHNSON & JOHNSON”
Tel: +370 5 278 68 88

България
”Джонсън & Джонсън България” ЕООД
Тел.:+359 2 489 94 00

Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: +32 14 64 94 11

Česká republika
Janssen-Cilag s.r.o.
Tel:+420 227 012 227

Magyarország
Janssen-Cilag Kft.
Tel.:+36 1 884 2858

Danmark
Janssen-Cilag A/S
Tlf: +45 45 94 82 82

Malta
AM MANGION LTD.
Tel: +356 2397 6000

Deutschland
Janssen-Cilag GmbH
Tel: +49 2137-955-955

Nederland
Janssen-Cilag B.V.
Tel: +31 76 711 1111

Eesti
UAB “JOHNSON & JOHNSON” Eesti filiaal
Tel.: +372 617 7410

Norge
Janssen-Cilag AS
Tlf: +47 24 12 65 00

Ελλάδα
Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε
Tηλ: +30 210 80 90 000

Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300

España
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00

Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.: +48 22 237 60 00

France
Janssen-Cilag
Tel: 0 800 25 50 75 / +33 1 55 00 40 03

Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600

Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700

România
Johnson & Johnson România SRL
Tel: +40 21 207 1800

Ireland
Janssen Sciences Ireland UC
Tel: 1 800 709 122
[email protected]

Slovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00

Ísland
Janssen-Cilag AB
C/o Vistor hf
Sími: +354 535 7000

Slovenská republika
Johnson & Johnson s.r.o.
Tel: +421 232 408 400

Italia
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1

Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300

Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Tηλ: +357 22 207 700

Sverige
Janssen-Cilag AB
Tfn: +46 8 626 50 00

Latvija
UAB “JOHNSON & JOHNSON” filiāle Latvijā
Tel: +371 6789 3561

United Kingdom (Northern Ireland)
Janssen Sciences Ireland UC
Tel: +44 1 494 567 444
[email protected]
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu.

Information intended for the doctor or healthcare professionals
The following information is intended exclusively for doctors or healthcare professionals and
must be read by doctors or healthcare professionals together with the complete prescribing
information (Summary of Product Characteristics)

Administer every 3 months

Shake the syringe vigorously for at least 15 seconds

For intramuscular injection only. Donot administer by any other route.

Important
Read all instructions carefully before use. TREVICTA requires careful attention to all points in these Instructions for Use to ensure successful administration.
TREVICTA must be administered by a healthcare professional as a single injection. DO NOT
fractionate the dose into multiple injections.
TREVICTA is intended for intramuscular use only. Inject slowly and deeply into the muscle
taking care to avoid injecting into a blood vessel.
Dosage
TREVICTA should be administered once every 3 months.
Preparation
Detach the label from the syringe and attach it to the patient’s medical record (chart).
TREVICTA requires longer and more vigorous shakingthan monthly paliperidone palmitate injectable.
Shake the syringe vigorously, with the tip pointing upwards, for
at least 15 seconds in the 5 minutes before administration(see Point 2).

Choice of thin-walled safety needle
Thin-walled safety needles are designed for use with TREVICTA. It is important
to use only the needles supplied in the TREVICTA pack.

Contents of the pack

1Needle selection
Needle selection is determined by the injection site and the patient’s weight.
Injection into the deltoidInjection into the gluteus

If the patient weighs

less than 90 kg
pink connector

regardless of patient weight
yellow connector

90 kg or more
yellow connector

Immediately discard unused needle in an appropriate
container. Do not save it for future use.

2Preparing the injection

SHAKE VIGOROUSLY
for at least 15 seconds
With the syringe tip pointing
upwards,SHAKE
VIGOROUSLY with a “loose wrist” for at least 15 seconds to
ensure a homogeneous suspension.

NOTE:This medicine requires
longer and more vigorous shaking
than monthly paliperidone
palmitate injectable.

Proceed to the next step
immediately after shaking. If more than
5 minutes pass before the injection is
given, shake again
vigorously, with the syringe tip pointing
upwards,for
at least 15 seconds to re-suspend the drug.

Check the suspension

After shaking the syringe for at least 15 seconds, check the appearance of the suspension in
the inspection window.
The suspension should appear uniform and milky white in colour.
It is also normal to see small air bubbles.

Open the blister containing the needle and remove the cap

First, open the blister with the needle by peeling back the lid only halfway and place it on a
flat surface.
Then, holding the syringe in a vertical position, remove the rubber cap with a twisting motion.

Grasp the blister with the needle

Fold back the needle cover and the plastic blister. Then firmly grasp the needle sheath
through the open wrapper, as shown in the figure.

Attach the needle

Hold the syringe pointing upwards. Connect the safety needle to the syringe using a slight
rotational movement to avoid breakage or damage to the needle connection. Always check
for any signs of damage or leakage before administration.

Remove the needle sheath

Pull the sheath off the needle with a straight pull.

Do notrotate the sheath, as the needle may loosen from the syringe.

Remove air bubbles

Hold the syringe in a vertical position and gently tap to allow air bubbles to rise to the top.
Slowly and carefully push the plunger forward to expel the air.

3Injection
Inject the dose

Inject the entire contents of the syringe slowlyintramuscularly, deep into the
deltoid or gluteal muscle selected.

Do not administer intravenously or subcutaneously.
4After the injection
Put the needle in safety

After the injection is complete, use your thumb or a flat surface to close the needle into
the safety mechanism. The needle is secure when you hear a “click”.

Dispose of properly

Dispose of the syringe and unused needle in an appropriate container.

Safety needles are specifically designed for use with
TREVICTA. The unused needle must be discarded and not
saved for future use.