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• leaflet MAH GENERIC_PL 35533-0036
• leaflet MAH GENERIC_PL 41734-0006

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Package leaflet: Information for the user

Voriconazole 200 mg

powder for solution for infusion

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor, pharmacist or nurse.

-    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Voriconazole 200 mg powder for solution for infusion; in the rest of the leaflet it will be called "Voriconazole".

What is in this leaflet

1.    What Voriconazole is and what it is used for

2.    What you need to know before you use Voriconazole

3.    How to use Voriconazole

4.    Possible side effects

5.    How to store Voriconazole

6.    Contents of the pack and other information

1.    What Voriconazole is and what it is used for

Voriconazole contains the active substance voriconazole. Voriconazole is an antifungal medicine. It works by killing or stopping the growth of the fungi that cause infections.

It is used for the treatment of patients (adults and children over the age of 2) with:

•    invasive aspergillosis (a type of fungal infection due to Aspergillus sp),

•    candidaemia (another type of fungal infection due to Candida sp) in non-neutropenic patients (patients without abnormally low white blood cells count),

•    serious invasive Candida sp. infections when the fungus is resistant to fluconazole (another antifungal medicine),

•    serious fungal infections caused by Scedosporium sp. or Fusarium sp. (two different species of fungi).

Voriconazole is intended for patients with worsening, possibly life-threatening, fungal infections.

Prevention of fungal infections in high risk bone marrow transplant recipients.

This product should only be used under the supervision of a doctor.

2.    What you need to know before you use Voriconazole

Do not use Voriconazole:

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

It is very important that you inform your doctor or pharmacist if you are taking or have taken any other medicines, even those that are obtained without a prescription, or herbal medicines.

The medicines in the following list must not be taken during your Voriconazole treatment:

•    Terfenadine (used for allergy)

•    Astemizole (used for allergy)

•    Cisapride (used for stomach problems)

•    Pimozide (used for treating mental illness)

•    Quinidine (used for irregular heart beat)

•    Rifampicin (used for treating tuberculosis)

•    Efavirenz (used for treating HIV) in doses of 400 mg and above once daily

•    Carbamazepine (used to treat seizures)

•    Phenobarbital (used for severe insomnia and seizures)

•    Ergot alkaloids (e.g., ergotamine, dihydroergotamine; used for migraine)

•    Sirolimus (used in transplant patients)

•    Ritonavir (used for treating HIV) in doses of 400 mg and more twice daily

•    St. John's Wort (herbal supplement)

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Voriconazole.

Talk to your doctor before taking Voriconazole if:

•    you have had an allergic reaction to other azoles,

•    you are suffering from, or have ever suffered from liver disease. If you have liver disease, your doctor may prescribe a lower dose

of Voriconazole . Your doctor should also monitor your liver function while you are being treated with Voriconazole by doing blood tests,

•    you are known to have cardiomyopathy, irregular heart beat, slow heart rate or an abnormality of electrocardiogram (ECG) called 'long QTc syndrome'.

You should avoid sunlight and sun exposure while being treated. It is important to cover sun exposed areas of skin and use sunscreen with high sun protection factor (SPF), as an increased sensitivity of skin to the sun's UV rays can occur. These precautions are also applicable to children.

While being treated with Voriconazole:

•    tell your doctor immediately if you develop

-    sunburn

-    severe skin rash or listers

-    bone pain

If you develop skin disorders as described above, your doctor may refer you to a dermatologist, who after consultation may decide that it is important for you to be seen on a regular basis. There is a small chance that skin cancer could develop with long-term use of Voriconazole.

Your doctor should monitor the function of your liver and kidney by doing blood tests.

Children and adolescents

Voriconazole should not be given to children younger than 2 years of age.

Other medicines and Voriconazole

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

Some medicines, when taken at the same time as Voriconazole , may affect the way Voriconazole works or Voriconazole may affect the way they work.

Tell your doctor if you are taking the following medicine, as treatment with Voriconazole at the same time should be avoided if possible:

•    Ritonavir (used for treating HIV) in doses of 100 mg twice daily

Tell your doctor if you are taking either of

the following medicines, as treatment with Voriconazole at the same time should be avoided if possible, and a dose adjustment of voriconazole may be required:

•    Rifabutin (used for treating tuberculosis). If you are already being treated with rifabutin your blood counts and side effects to rifabutin will need to be monitored.

•    Phenytoin (used to treat epilepsy). If you are already being treated with phenytoin your blood concentration of phenytoin will need to be monitored during your treatment with Voriconazole and your dose may be adjusted.

Tell your doctor if you are taking any of the following medicines, as a dose adjustment or monitoring may be required to check that the medicines and/ or Voriconazole are still having the desired effect:

•    Warfarin and other anticoagulants (e.g., phenprocoumon, acenocoumarol; used to slow down clotting of the blood)

•    Ciclosporin (used in transplant patients)

•    Tacrolimus (used in transplant patients)

•    Sulphonylureas (e.g., tolbutamide, glipizide, and glyburide) (used for diabetes)

•    Statins (e.g., atorvastatin, simvastatin) (used for lowering cholesterol)

•    Benzodiazepines (e.g., midazolam, triazolam) (used for severe insomnia and stress)

•    Omeprazole (used for treating ulcers)

•    Oral contraceptives (if you take Voriconazole whilst using oral contraceptives, you may get side effects such as nausea and menstrual disorders)

•    Vinca alkaloids (e.g., vincristine and vinblastine) (used in treating cancer)

•    Indinavir and other HIV protease inhibitors (used for treating HIV)

•    Non-nucleoside reverse transcriptase inhibitors (e.g. efavirenz, delavirdine, nevirapine) (used for treating HIV) (some doses of efavirenz can NOT be taken at the same time as Voriconazole)

•    Methadone (used to treat heroin addiction)

•    Alfentanil and fentanyl and other short acting opiates such as sufentanil (painkillers used for surgical procedures)

•    Oxycodone and other long-acting opiates such as hydrocodone (used for moderate to severe pain)

•    Non-steroidal anti-inflammatory drugs (e.g., ibuprofen, diclofenac) (used for treating pain and inflammation)

•    Fluconazole (used for fungal infections)

•    Everolimus (used for treating advanced kidney cancer and in transplant patients)

Pregnancy and breast-feeding

Voriconazole must not be used during pregnancy, unless indicated by your doctor. Effective contraception must be used in women of childbearing potential. Contact your doctor immediately if you become pregnant while being treated with Voriconazole.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Voriconazole may cause blurring of vision or uncomfortable sensitivity to light. While affected, do not drive or operate any tools or machines. Tell your doctor if you experience this.

Voriconazole contains sodium

This medicinal product contains up to 3 mmol (or 69 mg) sodium per vial. To be taken into consideration by patients on a controlled sodium diet.

3. How to use Voriconazole

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Your doctor will determine your dose depending on your weight and the type of infection you have.

Your doctor may change your dose depending on your condition.

Depending on your response to treatment, your doctor may decrease the dose to 3 mg/kg twice daily.

The doctor may decide to decrease the dose if you have mild to moderate cirrhosis.

Depending on your response to treatment, your doctor may increase or decrease the daily dose.

Voriconazole will be reconstituted and diluted to the correct concentration by your hospital pharmacist or nurse. (Please refer to the end of this leaflet for further information).

This will be given to you by intravenous infusion (into a vein) at a maximum rate of 3 mg/kg per hour over 1 to 3 hours.

If you or your child are taking Voriconazole for prevention of fungal infections, your doctor may stop giving Voriconazole if you or your child develop treatment related side effects.

If a dose of Voriconazole has been forgotten

As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed. However, tell your doctor, pharmacist or nurse if you think that a dose has been forgotten.

The following information is intended for

healthcare professionals only:

Reconstitution and Dilution information

•    Voriconazole needs to first be reconstituted with either 19 ml of Water for Injections or 19 ml of 9 mg/ml (0.9 %) Sodium Chloride for Infusion to obtain an extractable volume of 20 ml of clear concentrate containing

10 mg/ml voriconazole.

•    Discard the Voriconazole vial if the vacuum does not pull the diluent into the vial.

•    It is recommended to use a standard 20ml (non-automated) syringe to ensure that the exact amount (19.0 ml) of Water for Injections or of 9 mg/ml (0.9 %) Sodium Chloride for Infusion is dispensed.

•    The required volume of the reconstituted concentrate is then added to a recommended compatible infusion solution listed below to obtain a final Voriconazole solution containing 0.5 to 5 mg/ml of voriconazole.

•    This medicinal product is for single use only and any unused solution should be discarded and only clear solutions without particles should be used.

•    Not for administration as a bolus injection.

•    For storage information, please refer to Section 5 'How to store Voriconazole'.

If you stop using Voriconazole

Voriconazole treatment will continue for as long as your doctor advises, however duration of treatment with Voriconazole should be no more than 6 months.

Patients with a weakened immune system or those with difficult infections may require long term treatment to prevent the infection from returning. You may be switched from the intravenous infusion to tablets once your condition improves.

When Voriconazole treatment is stopped by your doctor you should not experience any effects.

If you have any further questions on 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 everybody gets them.

If any side effects occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.

Serious side effects - Stop taking Voriconazole and see a doctor immediately

•    Rash

•    Jaundice; Changes in blood tests of liver function

•    Pancreatitis

Other side effects

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

•    Visual impairment (change in vision)

•    Fever

•    Rash

•    Nausea, vomiting, diarrhoea

•    Headache

•    Swelling of the extremities

•    Stomach pains

•    Breathing difficulites

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

•    Flu-like symptoms, irritation and inflammation of the gastrointestinal tract, inflammation of the sinuses, inflammation of the gums, chills, weakness

•    Low numbers of some types of red or white blood cells, low numbers of cells called platelets that help the blood to clot

•    Allergic reaction or exaggerated immune response

•    Low blood sugar, low blood potassium, low sodium in the blood

•    Anxiety, depression, confusion, agitation, inability to sleep, hallucinations

•    Seizures, tremors or uncontrolled muscle movements, tingling or abnormal skin sensations, increase in muscle tone, sleepiness, 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)

•    Breathing difficulty, chest pain, swelling of the face, fluid accumulation in the lungs

•    Constipation, indigestion, inflammation of the lips

•    Jaundice, inflammation of the liver, redness of the skin

•    Skin rashes which may lead to severe

blistering and peeling of the skin characterized by a flat, red area on the skin that is covered with small confluent bumps

•    Itchiness

•    Hair loss

•    Back pain

•    Kidney failure, blood in the urine, changes in kidney function tests

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

•    Inflammation of the gastrointestinal tract causing antibiotic associated diarrhoea, inflammation of the lymphatic vessels

•    Inflammation of the thin tissue that lines the inner wall of the abdomen and covers the abdominal organ

•    Enlarged lymph glands (sometimes painful), disorder of blood clotting system, failure

of blood marrow, other blood cell changes (increased eosinophil and low white blood cells in blood)

•    Depressed function of the adrenal gland, underactive thyroid gland

•    Abnormal brain function, Parkinson-like symptoms, nerve injury resulting in numbness, pain, tingling or burning in the hands or feet

•    Problem with balance or coordination

•    Swelling of the brain

•    Double vision, serious conditions of the eye including: pain and inflammation of the eyes and eyelids, involuntary movement of the eye, abnormal eye movement, damage to the optic nerve resulting in vision impairment, optic disc swelling

•    Decreased sensitivity to touch

•    Abnormal sense of taste

•    Hearing difficulties, ringing in the ears, vertigo

•    Inflammation of certain internal organs-pancreas and duodenum, swelling and inflammation of the tongue

•    Enlarged liver, liver failure, gallbladder disease, gallstones

•    Joint inflammation, inflammation of the veins under the skin (which may be associated with the formation of a blood clot)

•    Inflammation of the kidney, proteins in the urine

•    Very fast heart rate or skipped heartbeats

•    Abnormal electrocardiogram (ECG)

•    Blood cholesterol increased, blood urea increased

•    Allergic skin reactions (sometimes severe), including widespread blistering rash and skin peeling, inflammation of the skin, the rapid swelling (edema) of the dermis, subcutaneous tissue, mucosa and submucosal tissues, itchy or sore patches of thick, red skin with silvery scales of skin, hives, sunburn or severe skin reaction following exposure to light or sun, skin redness and irritation, red or purple discoloration of the skin which may be caused by low platelet count, eczema

•    Injection site reaction

•    Life threatening allergic reaction

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

•    Overactive thyroid gland

•    Deterioration of brain function that is a serious complication of liver disease

•    Damage to the optic nerve resulting in vision impairment, clouding of the cornea

•    Bullous photosensitivity

•    A disorder in which the body's immune system attacks part of the peripheral nervous system

•    Severe heart rhythm problems that may be

life threatening

Other significant side effects whose frequency is not known, but should be reported to your doctor immediately:

•    Skin cancer

•    Inflammation of the tissue surrounding the bone

•    Red, scaly patches or ring-shaped skin lesions that may be a symptom of an autoimmune disease called cutaneous lupus erythematosus

Reactions during the infusion have occurred uncommonly with Voriconazole (including flushing, fever, sweating, increased heart rate and shortness of breath). Your doctor may stop the infusion if this occurs.

As Voriconazole has been known to affect the liver and the kidney, your doctor should monitor the function of your liver and kidney by doing blood tests. Please advise your doctor if you have any stomach pains or if your stools have a different consistency.

There have been reports of skin cancer in patients treated with Voriconazole for long periods of time.

Sunburn or severe skin reaction following exposure to light or sun was experienced more frequently in children. If you or your child develops skin disorders, your doctor may refer you to a dermatologist, who after consultation may decide that it is important for you or your child to be seen on a regular basis.

If any of these side effects persist or are troublesome, please tell your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly;

For UK - Via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

For Ireland - Via;

HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Voriconazole

Unopened vial: This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Once reconstituted, Voriconazole should be used immediately, but if necessary may be stored for up to 24 hours at 2 °C - 8 °C (in a refrigerator). Reconstituted Voriconazole needs to be diluted with a compatible infusion solution first before it is infused. (Please refer to the end of this leaflet for further information).

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the

environment.

6. Contents of the pack and other information

What Voriconazole contains

-    The active substance is voriconazole.

-    The other ingredients are hydroxypropylbetadex (MS 0.58 - 0.68), l-arginine, hydrochloric acid and sodium hydroxide.

Each vial contains 200mg voriconazole, equivalent to a 10 mg/ml solution when reconstituted as directed by your hospital pharmacist or nurse (see the information at the end of this leaflet).

What Voriconazole looks like and contents of the pack

Voriconazole is presented in 25 ml single use glass vials as a white or almost white lyophilized powder for solution for infusion in pack sizes of 1 and 20 vials per carton.

Marketing Authorisation Holder

Fresenius Kabi Limited Cestrian Court, Eastgate Way,

Runcorn, Cheshire,

WA71NT UK

Manufacturer

Fresenius Kabi Deutschland GmbH Pfingstweide 53 61169 Friedberg Germany

This product is authorised in the Member States of the EEA under the following names:

Belgium Voriconazol Fresenius Kabi 200 mg poeder voor oplossing voor infusie / poudre pour solution pour perfusion / Pulver zur Herstellung einer Infusionslosung

Bulgaria Voriconazole Fresenius Kabi 200 mg npax 3a MH#y3M0HeH pa3TBop Croatia Vorikonazol Fresenius Kabi 200 mg, prasak za otopinu za infuziju

Cyprus Voriconazole Fresenius Kabi 200 mg Kovip yia 5iaAupa npop syxuon

Czech    Voriconazole Fresenius Kabi 200 mg prasek pro infuznf

Republic    roztok

Germany Voriconazol Fresenius Kabi 200 mg Pulver zur Herstellung einer Infusionslosung Denmark Voriconazol Fresenius Kabi

Greece Voriconazole Fresenius Kabi 200 mg Kovip yia 5iaAupa npop syxuon

Spain    Voriconazol Fresenius Kabi 200 mg polvo para solucion

para perfusion

Finland    Voriconazole Fresenius Kabi

France    Voricanazole FRESENIUS KABI 200mg, poudre pour

solution pour perfusion

Hungary Voriconazole Fresenius Kabi 200 mg por oldatos infuziohoz

Ireland    Voriconazole    200 mg powder    for solution for infusion

Italy    Voriconazolo Fresenius Kabi

Luxembourg Voriconazol Fresenius Kabi 200 mg Pulver zur Herstellung einer Infusionslosung Norway    Voriconazole    Fresenius    Kabi 200 mg

Poland Voriconazole Fresenius Kabi, 200 mg, proszek do sporz^dzania roztworu do infuzji

Portugal Voriconazol Fresenius Kabi 200 mg Po para Solugao para Perfusao

Romania Voriconazol Fresenius Kabi 200 mg pulbere pentru solutie perfuzabila

Sweden    Voriconazole    Fresenius    Kabi

Slovenia Vorikonazol Fresenius Kabi 200 mg prasek za raztopino za infundiranje

Slovakia Voriconazole Fresenius Kabi 200 mg prasok na infuzny roztok

The    Voriconazol Fresenius Kabi 200 mg, poeder voor

Netherlands oplossing voor infusie

United Voriconazole 200 mg powder for solution for infusion Kingdom

This leaflet was last revised in Jul 2015.

FRESENIUS KABI

Voriconazole is a single dose unpreserved sterile lyophile. Therefore, from a microbiological point of view, once reconstituted or diluted, the product must be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C (in a refrigerator), unless reconstitution has taken place in controlled and validated aseptic conditions.

Chemical and physical in-use stability of the reconstituted product has been demonstrated for 24 hours at 2 °C to 8 °C.

Chemical and physical in-use stability of the diluted product has been demonstrated for 7 days at 2 °C to 8 °C.

Compatible Infusion Solutions:

The reconstituted solution can be diluted with:

Sodium Chloride 9 mg/ml (0.9 %) Solution for Injection

Compound Sodium Lactate Intravenous Infusion

5% Glucose Intravenous Infusion

0.45 % Sodium Chloride Intravenous Infusion

The compatibility of Voriconazole with diluents other than listed above (or listed below under 'Incompatibilities') is unknown.

Incompatibilities:

Voriconazole must not be infused into the same line or cannula concomitantly with other drug infusions, including parenteral nutrition (e.g., Aminofusin 10 % Plus).

Infusions of blood products must not occur simultaneously with Voriconazole.

Infusion of total parenteral nutrition can occur simultaneously with Voriconazole but not in the same line or cannula.

Voriconazole must not be diluted with 4.2 % Sodium Bicarbonate Infusion.

FRESENIUS

KABI