VFEND 200 mg vial
VFEND 200 mg vial
What is VFEND and what it is used
VFEND contains the active substance voriconazole. VFEND is an antifungal medicine. It works by killing or stopping the growth of fungi that cause infections.
It is used to treat patients (adults and children over 2 years):
Invasive aspergillosis (a type of fungal infection due to Aspergillus sp);
Candidemia (another type of fungal infection due to Candida sp) in neneutropenichni patients (patients in whom there was no abnormal low white blood cells);
Serious invasive infections with Candida sp., When fungi are resistant to fluconazole (another antifungal medicine);
Serious fungal infections caused by Scedosporium sp. or Fusarium sp. (Two different types of fungi).
VFEND is intended for patients with worsening, possibly life-threatening fungal infections.
This medication should be used only under medical supervision.
2 What you should know before taking VFEND
Do not use VFEND:
If you are allergic to voriconazole or any of the other ingredients in VFEND (listed in section 6).
It is important to tell your doctor or pharmacist if you are taking now or have taken any other medicines, even those bought without a prescription and herbal medicines.
The drugs included in the following list should not be used during the course of treatment with VFEND:
Terfenadine (used for allergy);
Astemizole (used for allergy);
Cisapride (used for stomach problems);
Pimozide (used to treat mental illness);
Quinidine (used for irregular heart beat);
Rifampicin (used to treat tuberculosis);
Efavirenz (used to treat HIV infection) at a dosage of 400 mg once a day and up;
Carbamazepine (used to treat seizures);
Phenobarbital (used for severe insomnia and seizures);
Ergot alkaloids (eg. Ergotamine, dihydroergotamine, used for migraine);
Sirolimus (used in patients with organ transplants);
Ritonavir (used to treat HIV infection) at doses of 400 mg and more twice daily;
St. John's Wort (herbal supplement).
Warnings and Precautions
Talk to your doctor before using VFEND, if:
You have had an allergic reaction to other azoles;
Suffer or have suffered from liver disease. If you have liver disease, your doctor may prescribe a lower dose of VFEND. Your doctor should also monitor your liver function with blood tests while you are being treated with VFEND;
You know that you have cardiomyopathy, irregular heart beat, slow heart rate or violations electrocardiogram (ECG) called "syndrome extended QT-interval".
You should avoid sunlight and sun exposure during treatment. It is important to cover part of the skin that are exposed to sunlight and use sunscreen because skin sensitivity to the sun's UV rays can be increased.
While being treated with VFEND:
Tell your doctor immediately if you experience severe skin rash or blisters or bone pain;
Your doctor should monitor the functioning of your liver and kidneys through blood tests.
Children and adolescents
VFEND should not be given to children under the age of 2 years.
Other medicines and VFEND:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some medicines taken at the same time with VFEND, may affect the way VFEND or VFEND may affect their operation.
Tell your doctor if you are taking any of the following medicines, as treatment with VFEND at the same time should be avoided if possible:
Ritonavir (used to treat HIV infection) at doses of 100 mg twice daily.
Tell your doctor if you are taking any of these drugs as treatment with VFEND at the same time should be avoided if possible and you may need a dose adjustment of voriconazole:
Rifabutin (used for tuberculosis). If you are already being treated with rifabutin, it will be necessary to monitor your blood counts and adverse reactions to rifabutin;
Phenytoin (used to treat epilepsy). If you are already being treated with phenytoin during VFEND treatment will require monitoring the concentration of phenytoin in your blood and you may need a dose adjustment.
Tell your doctor if you are taking any of the following medicines, as you may need a dose adjustment or monitoring to verify whether drugs and / or VFEND still have the desired effect:
Warfarin and other anticoagulants (eg. Phenprocoumon, acenocoumarol, used to slow blood clotting);
Cyclosporine (used in patients with organ transplants);
Tacrolimus (used in patients with organ transplants);
Sulfonylurea agents (eg. Tolbutamide, glipizide, and glyburide) (used for diabetes);
Statins (eg. Atorvastatin, simvastatin) (used to lower cholesterol);
Benzodiazepines (eg. Midazolam, triazolam) (used for severe insomnia and stress);
Omeprazole (used to treat ulcers);
Oral contraceptives (if you take VFEND while using oral contraceptives may have side effects such as nausea and menstrual disorders);
Vinca alkaloids (e.g.. Vincristine and vinblastine) (used to treat cancer);
Indinavir and other HIV protease inhibitors (used to treat HIV infection);
Non-nucleoside reverse transcriptase inhibitors (eg. Efavirenz, delavirdine, nevirapine) (used to treat HIV infection) (some doses of efavirenz may be administered simultaneously with VFEND);
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 agents (e.g. diclofenac) (used in the treatment of pain and inflammation);
Fluconazole (used for fungal infections);
Everolimus (used in the treatment of kidney cancer in advanced stages and in transplant patients).
Pregnancy and lactation:
VFEND should not be taken during pregnancy unless medically indicated. In women of childbearing age are recommended to use effective contraception. Contact your doctor immediately if you become pregnant during treatment with VFEND.
VFEND should not be used during lactation. Ask your doctor or pharmacist for advice before you start using any medicine if you are breastfeeding.
Driving and using machines
VFEND can cause blurred vision or sensitivity to light unpleasant. If affected, do not drive or operate any tools or machines. Talk to your doctor if you experience this.
VFEND contain sodium:
Each vial of VFEND contains 217,6 mg sodium per vial. This should be considered if you are strictly controlled sodium diet.
3 How to take VFEND
Always take this medicine exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
Your doctor will determine your dose based on body weight and the type of infection you have.
Your doctor may adjust your dose depending on your condition.
The recommended dose for adults (including the elderly) is as follows:
Dose for the first 24 hours (loading dose): IV - 6 mg / kg every 12 hours for the first 24 hours;
Dose after the first 24 hours (maintenance dose): IV - 4 mg / kg twice daily.
Depending on your response to treatment, your doctor may reduce the daily dose to 3 mg / kg twice daily.
The doctor may decide to increase the dose if you have mild to moderate cirrhosis.
Use in children and adolescents
The recommended dose in children and adolescents is as follows:
Children aged 2 to under 12 years and adolescents aged 12 to 14 years and weighing less than 50 kg
Adolescents aged 12 to 14 years weighing 50 kg or more; all adolescents over 14 years
Dose for the first 24 hours (loading dose) 9 mg / kg every 12 hours for the first 24 hours 6 mg / kg for 1 2 hours in the first 24 hours
Dose after the first 24 hours (maintenance dose) 8 mg / kg twice daily 4 mg / kg twice daily
Depending on your response to treatment, your doctor may increase or decrease the daily dose.
VFEND powder for solution for infusion will be dissolved and diluted to the required concentration of your hospital pharmacist or nurse. (Please see the end of this leaflet for further information).
The preparation quantity will be given by intravenous infusion (into a vein) with a maximum rate of 3 mg / kg per hour in the range of 1 to 3 hours.
If a dose is missed VFEND
Since you will receive the drug under medical supervision, the probability of missed dose is small. However, tell your doctor or pharmacist if you think that a dose was missed.
If you stop taking VFEND
VFEND treatment duration will be determined by your doctor, but the duration of treatment with VFEND powder for solution for infusion should not exceed 6 months.
Patients with a weakened immune system or those with difficult infections may require long term treatment to prevent return of the infection.
If VFEND treatment is stopped by your doctor, you will not feel any effects.
If you have any further questions on 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. If any side effects, most likely to be minor and temporary. Some of them, however, can be serious and require medical care.
Serious side effects - stop taking VFEND and seek medical attention immediately:
jaundice; changes in blood tests of liver function;
Inflammation of the pancreas which causes severe pain in the abdomen and back.
Other side effects
Very common side effects (may affect more than 1 in 10 people):
Visual disturbances (changes in vision);
Nausea, vomiting, diarrhea;
Swelling of the extremities;
Common side effects (may affect up to 1 in 10 people):
Flu-like symptoms, inflammation of the sinuses, fever, weakness;
Low number of cells called platelets that help the blood to clot, low numbers of certain white blood cells, or all kinds of blood cells, red or purple color of the skin, which may be caused by a low platelet count, other variations of blood cells;
Low blood sugar, low blood potassium;
Anxiety, depression, numbness, confusion, dizziness, agitation, hallucinations and neurological symptoms;
Heart rhythm problems, including a very strong heartbeat, very slow heartbeat, fainting;
Low blood pressure, inflammation of the veins (which may be associated with the formation of a blood clot);
Difficulty breathing, chest pain, fluid in the lungs;
Jaundice, redness of the skin;
Swelling of the lips or face;
Allergic reactions (sometimes severe), including widespread blistering and peeling skin, severe skin reaction after exposure to light or sun;
Renal failure, blood in urine, changes in blood tests of kidney function;
Changes in blood tests of liver function;
Irritation of the gastrointestinal tract.
Uncommon side effects (may affect up to 1 in 100 people):
Enlarged lymph glands (sometimes painful);
An increased number of white blood cells, which may be associated with an allergic reaction, impaired blood clotting system;
Heart rhythm problems, including fast or slow heartbeat, fainting;
Suppressed function of the adrenal gland;
Swelling of the brain;
Double vision, pain and inflammation of the eyes and eyelids, involuntary eye movement;
Decreased sensitivity to touch;
Constipation, inflammation of the upper part of the small intestine, indigestion, pancreatitis, peritonitis;
Swelling and inflammation of the tongue;
Enlarged liver, hepatitis, liver failure, gallbladder disease, gall bladder stones;
Inflammation of the kidneys, protein in the urine;
Deviation in the electrocardiogram (ECG);
Changes in biochemical blood tests;
Skin rash, which can lead to severe rash associated with blistering and peeling of the skin;
Swelling and inflammation of the skin, rashes, redness and irritation.
Rare side effects (may affect up to 1 in 1000 people):
Difficulty hearing, ringing in the ears;
Increase in muscle tone, muscle weakness caused by abnormal response of the immune system;
Altered brain function, Parkinson-like symptoms, seizures, nerve damage leading to numbness, pain, tingling or burning in the hands and feet;
Severe, persistent or bloody diarrhea associated with abdominal pain or fever;
Overactive or underactive thyroid gland;
Damage to the optic nerve leading to impaired vision, eye haemorrhage, abnormal eye movements, corneal opacity;
Heart rhythm disorders, including fast or slow heartbeat;
Lymphatic infection, loss of consciousness as a result of liver failure.
Observed reactions were uncommon during the infusion of VFEND (including flushing, fever, sweating, increased heart rate and rapid breathing). Your doctor may stop the infusion if it occurs.
Since it is known that VFEND affects the liver and kidneys, your doctor should monitor the function of your liver and kidneys through blood tests. Tell your doctor if you have stomach pain or your stools are changed texture.
If you get any side effects, tell your doctor or pharmacist. This includes all listed in this leaflet.
5 How to store VFEND
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
After reconstitution VFEND should be used immediately, but if necessary can be stored up to 24 hours at 2 ° C - 8 ° C (in a refrigerator). reconstituted VFEND
must be diluted with a compatible infusion solution prior to infusion. (Please read the additional information given at the end of this leaflet).
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6 Package Contents and more information
What does VFEND:
The active substance is voriconazole.
The other ingredient is sulphobutylether beta cyclodextrin sodium. Each vial contains 200 mg of voriconazole, corresponding to 10 mg / ml solution after reconstitution as instructed by the hospital pharmacist or nurse (see. Information at the end of this leaflet).
VFEND looks like and contents of the pack
VFEND comes in a glass vial for single use as a powder for solution for infusion.