VORICONAZOLO 200 mg Порошок Для Раствора Для Внутривенного Введения

Содержание инструкции

1. Voriconazole Hikma 200 mg powder for solution for infusion
   1. What you need to know before taking Voriconazolo Hikma
   2. How to take Voriconazolo Hikma
   3. Possible side effects
   4. How to store Voriconazolo Hikma
   5. Content of the pack and other information

Voriconazole Hikma 200 mg powder for solution for infusion

voriconazole

Read this leaflet carefully before you start 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, pharmacist or nurse.
• 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 may be harmful.
• 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 is Voriconazole Hikma and what it is used for
• 2. What you need to know before you take Voriconazole Hikma
• 3. How to use Voriconazole Hikma
• 4. Possible side effects
• 5. How to store Voriconazole Hikma
• 6. Contents of the pack and other information
• 1. What is Voriconazole Hikma and what it is used for

Voriconazole Hikma contains the active ingredient voriconazole. Voriconazole Hikma is an antifungal
medicine. It works by stopping the growth or killing fungi that cause infections.
It is used for the treatment of patients (adults and children over 2 years of age) with:

• invasive aspergillosis (a type of fungal infection caused by Aspergillusspecies),
• candidemia (another type of fungal infection caused by Candidaspecies) in non-neutropenic patients (patients who do not have an unusually low white blood cell count),
• serious and invasive infections caused by Candidaspecies, when the fungus is resistant to fluconazole (another antifungal medicine),
• serious fungalinfections caused by Scedosporiumand Fusariumspecies (two different types of fungi).

Voriconazole Hikma is indicated for patients with worsening fungal infections and
potentially life-threatening.
Prevention of fungal infections in patients undergoing high-risk bone marrow transplantation.
This medicine should only be used under medical supervision.

2. What you need to know before taking Voriconazolo Hikma

Do not take Voriconazolo Hikma:

• If you are allergic to the active ingredient voriconazole or to sodium sulfobutylether beta-cyclodextrin (listed in section 6).

It is very important that you inform your doctor or pharmacist if you are taking or have taken other
medicines, even those without a prescription, or herbal preparations.
The medicines included in the list below should not be used during
treatment with Voriconazolo Hikma:

• Terfenadine (for allergies)
• Astemizole (for allergies)
• Cisapride (for stomach problems)
• Pimozide (for the treatment of mental illnesses)
• Quinidine (for irregular heartbeat)
• Ivabradine (for symptoms of chronic heart failure)
• Rifampicin (for the treatment of tuberculosis)
• Efavirenz (for the treatment of AIDS) in doses equal to or greater than 400 mg once a day
• Carbamazepine (for the treatment of seizures)
• Phenobarbital (for severe insomnia and seizures)
• Ergot alkaloids (e.g., ergotamine, dihydroergotamine; for migraine)
• Sirolimus (for patients undergoing transplantation)
• Ritonavir (for the treatment of AIDS) in doses of 400 mg and over, twice a day
• St John's Wort (Hypericum - herbal medicinal product supplement)
• Naloxegol (for the treatment of constipation specifically caused by pain medications, called opioids [e.g. morphine, oxycodone, fentanyl, tramadol, codeine])
• Tolvaptan (for the treatment of hyponatremia, i.e. low sodium levels in the blood, or to slow the decline in kidney function in patients with polycystic kidney disease)
• Lurasidone (for the treatment of depression)
• Venetoclax (for the treatment of patients with chronic lymphocytic leukemia-CLL)

Warnings and precautions
Consult your doctor, pharmacist or nurse before taking Voriconazolo Hikma if:

• you have had an allergic reaction to other azoles.
• you suffer from or have suffered from a liver disease. If you have liver problems, your doctor may prescribe a lower dose of Voriconazolo Hikma. Your doctor will need to check your liver function during treatment with Voriconazolo Hikma by taking blood tests.
• you know you have heart disease, an irregular heartbeat, a slowed heartbeat or an abnormality in your electrocardiogram (ECG) called “long QT syndrome”.

You must avoid any exposure to the sun and sunlight during treatment. It is important
to cover skin areas exposed to the sun and use sunscreens with a high protection factor (SPF),
as increased skin sensitivity to UV rays from the sun may occur. These precautions are
also valid for children.
During treatment with Voriconazolo Hikma:

• immediately inform your doctor if you develop
• sunburn
• severe skin reaction or blisters
• bone pain

If you develop any of the skin conditions described above, your doctor may refer you to a
dermatologist, who after consultation may decide that it is important to have you undergo regular visits. After prolonged use of Voriconazolo Hikma, there is a small risk of
developing skin cancer.
If you develop signs of “adrenal insufficiency” in which the adrenal glands do not produce
adequate amounts of certain steroid hormones such as cortisol, which can cause symptoms such as:
chronic or persistent fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain, inform your doctor.
Inform your doctor if you develop signs of “Cushing's syndrome” in which the body produces excessive amounts of the hormone cortisol, which can cause symptoms such as weight gain, fat accumulation
between the shoulders, a rounded face, darkening of the skin of the abdomen, thinning of legs,
breasts and arms, thinning of the skin, easy bruising, increased blood sugar, excessive hair growth on the body, excessive sweating.
Your doctor will need to check your liver and kidney function by taking blood tests.

Children and adolescents
Voriconazolo Hikma should not be given to children under 2 years of age.

Other medicines and Voriconazolo Hikma:
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, even those without a prescription.
Some medicines, when taken at the same time as Voriconazolo Hikma, may change
the activity of Voriconazolo Hikma or Voriconazolo Hikma may change the activity of these
medicines.
Tell your doctor if you are taking the following medicine because, if possible, concomitant treatment with Voriconazolo Hikma should be avoided:

• Ritonavir (for the treatment of AIDS) in doses of 100 mg twice a day
• Glasdegib (for the treatment of cancer): if you need to use both drugs, your doctor will often check your heart rate

Tell your doctor if you are taking any of these medicines because, if possible, concomitant treatment
with Voriconazolo Hikma should be avoided and a dose adjustment of voriconazole may be necessary:

• Rifabutin (for the treatment of tuberculosis). If you are already being treated with rifabutin, the blood cell count and side effects of rifabutin should be monitored.
• Phenytoin (for the treatment of epilepsy). If you are already being treated with phenytoin, phenytoin levels in the blood should be monitored during treatment with Voriconazolo Hikma and the dose you are taking may be adjusted.

Tell your doctor if you are taking any of these medicines because a dose adjustment or monitoring may be necessary to verify that these medicines and/or Voriconazolo Hikma
continue to have the desired effect:

• Warfarin and other anticoagulants (e.g., phenprocoumon, acenocoumarol) (to slow the blood clotting process)
• Cyclosporine (for patients undergoing transplantation)
• Tacrolimus (for patients undergoing transplantation)
• Sulfonylureas (e.g., tolbutamide, glipizide and gliburide) (for diabetes)
• Statins (e.g., atorvastatin, simvastatin) (to reduce cholesterol)
• Benzodiazepines (e.g., midazolam, triazolam) (for severe insomnia and stress)
• Omeprazole (for the treatment of ulcers)
• Oral contraceptives (if you take Voriconazolo Hikma during treatment with oral contraceptives, side effects such as nausea and menstrual disorders may occur)
• Vinca alkaloids (e.g., vincristine and vinblastine) (for the treatment of cancer)
• Tyrosine kinase inhibitors (e.g. axitinib, bosutinib, cabozantinib, ceritinib, cobimetinib, dabrafenib, dasatinib, nilotinib, sunitinib, ibrutinib, ribociclib) (for the treatment of cancer)
• Tretinoin (for the treatment of leukemia)
• Indinavir and other AIDS protease inhibitors (for the treatment of AIDS)
• Non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, delavirdine, nevirapine) (for the treatment of AIDS) (some doses of efavirenz CANNOT be taken with Voriconazolo Hikma)
• Methadone (for the treatment of heroin addiction)
• Alfentanil and fentanyl and other short-acting opioids such as sufentanil (pain relievers used in surgical procedures)
• Oxycodone and other long-acting opioids such as hydrocodone (used to treat moderate to severe pain)
• Non-Steroidal Anti-Inflammatory Drugs (e.g., ibuprofen, diclofenac) (used to treat pain and inflammation)
• Fluconazole (used to treat fungal infections)
• Everolimus (used to treat advanced kidney cancer and patients undergoing transplantation)
• Letermovir (used to prevent cytomegalovirus (CMV) disease following bone marrow transplantation)
• Ivacaftor (used to treat cystic fibrosis)
• Flucloxacillin (antibiotic indicated in bacterial infections)

Pregnancy and breastfeeding
Voriconazolo Hikma should not be used during pregnancy unless decided
by your doctor. Women of childbearing potential must use adequate contraception. Contact
your doctor immediately if you become pregnant during treatment with Voriconazolo Hikma.
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.

Driving and operating machinery
Voriconazolo Hikma may cause blurred vision or a bothersome sensitivity to light. In such
cases, you should not drive and should not use tools or machinery. Contact your doctor in these cases.

Voriconazolo Hikma contains sodium
This medicine contains 217.6 mg of sodium (the main component of table salt) per
vial. This is equivalent to 10.9% of the recommended maximum daily intake with the diet of
an adult.

Voriconazolo Hikma contains cyclodextrins
This medicine contains 3200 mg of cyclodextrins per vial, which corresponds to 160 mg/ml
when reconstituted in 20 ml. If you have kidney problems, talk to your doctor before taking
this medicine.

3. How to take Voriconazolo Hikma

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor.
The doctor will establish the appropriate dose for you based on your weight and the type of infection diagnosed.
The doctor may adjust the dose based on your condition.
The recommended dose for adults (including elderly patients) is as follows:

Based on the response to treatment, the doctor may decrease the dose to 3 mg/kg twice a day.
If you have mild to moderate cirrhosis, your doctor may decide to reduce the dose.

Use in children and adolescents
The recommended dose in children and adolescents is as follows:

Based on the response to treatment, the doctor may increase or decrease the daily dose.
Voriconazolo Hikma powder for solution for intravenous infusion will be reconstituted and diluted by the
pharmacist or the hospital nurse to obtain the correct concentration. (For further
The medicine will be administered to you by intravenous infusion (into a vein) at a maximum
infusion rate of 3 mg/kg/h over 1-3 hours.
If you or your child are taking Voriconazolo Hikma for the prevention of fungal infections,
your doctor may decide to discontinue the administration of Voriconazolo Hikma if you or your
child should develop adverse effects related to the treatment.

If you forget to take a dose of Voriconazolo Hikma:
Since this medicine will be administered under medical supervision, it is unlikely that a dose will be omitted.
However, if you think that a dose has been forgotten, report it to your doctor or pharmacist.

If you stop taking Voriconazolo Hikma:
Treatment with Voriconazolo Hikma must continue as long as your doctor decides; however, the
duration of treatment with Voriconazolo Hikma powder for solution for intravenous infusion should not
exceed 6 months.
Patients with a weakened immune system or those who have infections that are difficult to treat
may require long-term treatment to prevent the infection from returning. When your
conditions improve, you may be switched from intravenous treatment to tablets.
When treatment with Voriconazolo Hikma is stopped at the request of the doctor, no effects should
occur.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If side effects occur, most will likely be mild and
transient. However, some may be serious and require medical attention.

Serious side effects - Stop taking Voriconazolo Hikma and consult your doctor immediately

• Skin rash
• Jaundice, changes in liver function tests
• Pancreatitis

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

• Impaired vision (changes in vision including blurred vision, altered color vision, abnormal intolerance to visual perception of light, color blindness, eye disease, halo vision, night blindness, oscillating vision, seeing sparks, visual aura, reduced visual acuity, visual brightness, partial loss of visual field, spots in front of the eyes)
• Fever
• Skin rashes
• Nausea, vomiting, diarrhea
• Headache
• Swelling of the extremities
• Stomach pain
• Difficulty breathing
• Elevated liver enzymes

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

• Inflammation of the paranasal sinuses, inflammation of the gums, chills, fatigue
• Reduction, even severe, in the number of some types of red blood cells (sometimes immune-related) and/or white blood cells (sometimes with fever), reduction in the number of blood cells (called platelets) that help blood clotting
• Low blood sugar levels, low blood potassium levels, low blood sodium levels
• Anxiety, depression, confusion, agitation, sleep disorders, hallucinations
• Convulsions, tremor or uncontrolled muscle movements, tingling or abnormal skin sensations, increased muscle tone, drowsiness, dizziness
• Bleeding in the eye
• Heart rhythm problems including very fast heartbeat, very slow heartbeat, fainting
• Low blood pressure, inflammation of a vein (which may be associated with the
• formation of a blood clot)
• Acute difficulty breathing, chest pain, swelling of the face (mouth, lips and around the eyes), fluid accumulation in the lungs
• Constipation, indigestion, inflammation of the lips
• Jaundice, inflammation of the liver and liver damage
• Skin rash that may involve blistering and severe skin peeling, characterized by a flat and reddened area of skin with small confluent bumps, skin redness
• Itching
• Hair loss
• Back pain
• Kidney failure, blood in the urine, changes in kidney function tests

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

• Flu-like symptoms, irritation and inflammation of the gastrointestinal tract, inflammation of the gastrointestinal tract that can cause antibiotic-associated diarrhea,

inflammation of the lymphatic vessels

• Inflammation of the thin tissue lining the inner wall of the abdomen and covering the abdominal organs
• Enlarged lymph nodes (sometimes painful), bone marrow failure, increased eosinophils
• Reduced function of the adrenal glands, reduced activity of the thyroid gland
• Changes in brain function, Parkinson-like symptoms, nerve damage resulting in numbness, pain, tingling or burning in the hands or feet
• Problems with balance and coordination
• Brain edema
• Double vision, serious eye conditions including: pain and inflammation of the eyes and eyelids, abnormal eye movements, damage to the optic nerve with impaired vision, swelling of the optic disc
• Reduced sensitivity to touch
• Changes in taste
• Hearing disorders, ringing in the ears, vertigo
• Inflammation of some internal organs - pancreas and duodenum, swelling and inflammation of the tongue
• Enlargement of the liver, liver failure, gallbladder diseases, gallstones
• Inflammation of the joints, inflammation of superficial veins (which may be associated with the formation of blood clots)
• Inflammation of the kidneys, presence of protein in the urine, kidney damage
• Very fast heart rate or missed beats, sometimes with irregular electrical impulses
• Altered electrocardiogram (ECG)
• Increased cholesterol, increased urea in the blood
• Allergic skin reactions (sometimes serious) including a potentially life-threatening skin condition causing blisters and painful sores on the skin and mucous membranes, especially in the mouth, skin inflammation, urticaria, sunburn or severe skin reaction following exposure to light or sun, skin redness and irritation, change in skin color, red or purple, which may be caused by a low platelet count, eczema
• Infusion site reaction
• Allergic reactions or exaggerated immune response

Rare (may affect up to 1 in 1000 people):

• Hyperactive thyroid gland
• Deterioration of brain function, serious complication of liver disease
• Loss of a large part of the optic nerve fibers, corneal opacity, involuntary eye movement
• Bullous photosensitivity
• Disorder in which the body's immune system attacks part of the peripheral nervous system
• Heart rhythm problems of conduction (sometimes fatal)
• Potentially life-threatening allergic reaction
• Disorders of the blood coagulation system
• Allergic skin reactions (sometimes serious), including rapid swelling (edema) of the dermis, subcutaneous tissue, mucous membranes and submucosal tissues, itchy or painful patches of thickened and scaly skin with silvery scales, skin irritation and mucous membrane irritation, a potentially life-threatening skin condition causing large areas of the epidermis (the outer layer of skin) to detach from the underlying skin layers
• Small patches of dry, scaly skin, sometimes thick with bumps or ‘horns’

Side effects with unknown frequency:

• Freckles and pigmented spots

Other significant side effects, whose frequency is unknown but which should be reported
immediately to the doctor are:

• Skin cancer
• Inflammation of the tissues surrounding the bones
• Red, scaly or ring-shaped skin lesions that may be symptoms of an autoimmune disease called systemic lupus erythematosus

The onset of reactions (including skin redness, fever, sweating, increased heart rate and shortness of
breath) during the infusion of Voriconazolo Hikma is uncommon. If one or more of these reactions
occur, your doctor may decide to stop the infusion.
Since Voriconazolo Hikma has been shown to have effects on the liver and kidneys, the doctor will need
to monitor liver and kidney function by performing blood tests. Tell your doctor if you have
stomach pain or if your stools are of a different consistency than usual.
Cases of skin cancer have been reported in patients treated with voriconazole for
prolonged periods.
Sunburn or a severe skin reaction following exposure to light or sun has been
reported more frequently in children. If you or your child develops skin disorders, your
doctor may have you or your child visit a dermatologist who can decide whether it is important for you or
your child to continue regular visits with the dermatologist. Elevated liver enzymes have also
been observed more frequently in children.
If any of these side effects persist or are bothersome, tell your doctor.

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

5. How to store Voriconazolo Hikma

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 label after EXP. The expiry
date refers to the last day of that month.
This medicine does not require any particular storage temperature. Store in the
original package to protect the medicine from light.
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. Content of the pack and other information

What contains Voriconazolo Hikma

• The active ingredient is voriconazole. Each vial contains 200 mg of voriconazole, equivalent to a solution of 10 mg/ml, when reconstituted as recommended by the pharmacist or hospital nurse
• The other component is sulfobutylether beta cyclodextrin sodium.

Description of the appearance of Voriconazolo Hikma and content of the pack
Voriconazolo Hikma is a pasty white to almost white powder.
Voriconazolo Hikma is available in packs of 1 or 5 glass vials as powder for
infusion solution. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó n.º 8, 8A e 8B, Fervença
2705-906 Terrugem SNT
Portugal

Manufacturers
Hikma Italia S.p.A.
Viale Certosa, 10
27100 Pavia
Italy
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

AT / BE / DE / NL
Hikma Pharma GmbH
Tel: +49 89-45450-302

IT
Hikma Italia S.p.A.
Tel: + 39 0382 1751801

BG / CY / CZ / DK / EE / ES / EL / FI / HR /
HU / IE / IS / LI / LT / LU / LV / MT / NO / PL
/ PT / RO / SE / SI / SK
Hikma Farmacêutica (Portugal), S.A.
Tel.: +351 219 608 410

UK
Consilient Health Ltd
Tel.: +44(0)203 751 1888

FR
Hikma France
Tel.: +33(0) 1 87 69 98 43
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/.
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The following information is intended exclusively for healthcare professionals:

Information on reconstitution and dilution
Voriconazolo Hikma powder for solution for infusion must be reconstituted with either 19 ml of water
for injections or with 19 ml of Sodium chloride 9 mg/ml (0.9%) solution for infusion
to obtain a withdrawable volume of 20 ml of a clear concentrate containing 10 mg/ml of
voriconazole.
It is recommended to use a standard 20 ml syringe (non-automatic) to ensure that the exact amount of water
for injections (19.0 ml) or sodium chloride 9 mg/ml (0.9%) injection solution is withdrawn.
After reconstitution with 19 ml of water for injections or 0.9% sodium chloride injection solution, a clear and
colourless solution is obtained.
For administration, the required volume of the reconstituted concentrate is added to the compatible
infusion solution (detailed below) in order to obtain a final Voriconazolo Hikma solution containing 0.5-5 mg/ml.
This medicinal product is for single use only, unused solution must be discarded and only solutions without
visible particles must be used.
The product must not be administered as a bolus
Before use, this medicinal product does not require any special temperature conditions for
storage. Store in its original packaging to protect the medicinal product from light.

Required volumes of Voriconazolo Hikma Concentrate 10 mg/ml Concentrate
Voriconazolo Hikma is a sterile, lyophilised powder in a single dose without preservatives.
Stability after reconstitution:
Chemical and physical stability in use has been demonstrated for 36 hours between 2°C and 8°C for the
reconstituted solution.
Stability after dilution:
The chemical and physical stability of the diluted solution for infusion has been demonstrated for a period of
36 hours at a temperature between 2°C and 8°C followed by 3 hours at room temperature.
From a microbiological point of view, after reconstitution, the medicinal product must be used
immediately. If not used immediately, the storage times and conditions of the reconstituted vial before use are the
responsibility of the user and normally should not exceed 24 hours between 2°C and 8°C (in a refrigerator), unless
the reconstitution has been carried out under controlled and validated aseptic conditions.

Compatible Infusion Solutions:
The reconstituted solution can be diluted in:

Sodium chloride 9 mg/ml (0.9%) injection solution
Intravenous infusion of sodium lactate
Intravenous infusion of 5% glucose and Ringer lactate
Intravenous infusion of 5% glucose and 0.45% sodium chloride
Intravenous infusion of 5% glucose
Intravenous infusion of 5% glucose in 20 mEq of potassium chloride
Intravenous infusion of 0.45% sodium chloride
Intravenous infusion of 5% glucose and 0.9% sodium chloride
The compatibility of Voriconazolo Hikma with other solvents apart from those detailed above (or listed in the ‘Incompatibilities’ section below) is not known.

Incompatibilities:
Voriconazolo Hikma must not be infused together with other infusion drugs from the same infusion line or cannula, including parenteral nutrition (e.g. Aminofusin 10% Plus).
The infusion of blood products must not occur simultaneously with Voriconazolo Hikma.
Total parenteral nutrition can be administered together with Voriconazolo Hikma but not in the same line or through the same cannula.
Voriconazolo Hikma must not be diluted with 4.2% Sodium Bicarbonate Solution.