VFEND 50 mg film-coated tablets Voriconazole - United Kingdom[英国药品]

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VFEND 50 mg film-coated tablets Voriconazole

2014-12-28 17:37:18 来源: 作者: 【大中小】浏览:365次评论:0条

For doctors

What is it and how is it used?

VFEND belongs to a group of medicines called triazole antifungal agents. These medicines are used to treat a wide variety of fungal infections. VFEND works by killing or stopping the growth of the fungi that cause infections.

What fungal infections are treated with VFEND?
VFEND is used to treat serious fungal infections caused by Aspergillus, Scedosporium, Fusarium, fluconazole-resistant Candida, and candidaemia in patients with normal white blood cell counts. This product should only be taken under the supervision of a doctor.

VFEND is mainly for use in seriously ill patients.

What do you have to consider before using it?

Do not take VFEND:
-If you are allergic to voriconazole or any of the other ingredients of VFEND

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. Some medicines affect the way VFEND works, or VFEND may affect the way they work.

A list of the medicines that may affect VFEND is shown in the section ‘Taking other medicines with VFEND’. However, the medicines in the following list must not be taken during your course of VFEND treatment:

Take special care with VFEND:

Taking other medicines with VFEND:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those that are obtained without a prescription.

Some medicines, when taken at the same time as VFEND, may affect the way VFEND works or VFEND may affect the way they work. Tell your doctor if you are taking any of the following medicines, as VFEND must not be taken if you are already taking any of these medicines (See also Section 2 above ‘Do not take VFEND’):

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

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 VFEND are still having the desired effect:

Before being treated with VFEND, tell your doctor if:

While being treated with VFEND:

Taking VFEND with food and drink:
VFEND tablets must be taken at least one hour before or one hour after a meal.

Pregnancy and breast-feeding:
VFEND must not be taken 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 taking VFEND.

VFEND must not be taken during breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine whilst breast-feeding.

Driving and using machines:
VFEND may cause blurring of vision or uncomfortable sensitivity to light. While affected, do not drive or operate any tools or machines. Contact your doctor if you experience this.

Important information about some of the ingredients of VFEND:
VFEND tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking VFEND.

How is it used?

Always take VFEND exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

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

The usual dose for adults including elderly patients is as follows Tablets Patients 40 kg and above Patients less than 40 kg Dose for the first 24 hours Loading Dose 400 mg every 12 hours for the first 24 hours 200 mg every 12 hours for the first 24 hours 200 mg twice a day 100 mg twice a day Dose after the first 24 hours Maintenance Dose

Depending on your response to treatment, your doctor may increase the daily dose to 300 mg twice a day.

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

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

Teenagers (aged 12 to 16 years) should be dosed as for adults.

Take your tablet at least one hour before, or one hour after a meal. Swallow the tablet whole with some water.

Continue taking VFEND until your doctor tells you to stop. Do not stop treatment early because your infection may not be cured. Patients with a weakened immune system or those with difficult infections may require long term treatment to prevent the infection from returning.

If you take more VFEND than you should:
If you take more tablets than prescribed (or if someone else takes your tablets) you must seek medical advice or go to the nearest hospital casualty department immediately. Take your box of VFEND tablets with you.

If you forget to take VFEND:
It is important to take your VFEND tablets regularly at the same time each day. If you forget to take one dose, take your next dose when it is due. Do not take a double dose to make up for a forgotten dose.

If you stop taking VFEND:
It has been shown that taking all doses at the appropriate times may greatly increase the effectiveness of your medicine. Therefore unless your doctor instructs you to stop treatment, it is important to keep taking VFEND correctly, as described above.

When VFEND treatment is stopped by your doctor you should not experience any effects. However if you were taking medicines containing ciclosporin or tacrolimus you must mention this to your doctor, as the dose will need to be adjusted.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, VFEND 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.

Very common side effects (occurring in at least 1 in 10 patients) are:

Common side effects (occurring in at least 1 in 100 patients) are:

Uncommon side effects (occurring in at least 1 in 1,000 patients) are:

Rare side effects (occurring in at least 1 in 10,000 patients) are:

As VFEND 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.

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

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

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

There are no special storage instructions.

Medicines should not be disposed of via wastewater or houshold waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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For doctors

What is it?

VFEND contains the active substance voriconazole. It is available as white tablets, which contain 50 mg or 200 mg of voriconazole, as an oral suspension, which contains 40 mg/ml of voriconazole, and as a white powder to be made into a solution for infusion (drip into a vein).

What is it used for?

VFEND is an antifungal medicine. It is used for the treatment of patients (adults and children over the age of 2) with:

How is it used?

VFEND is given twice daily. The dosage of VFEND to use depends on the weight of the patient and on the presentation used; for the full information, please see the Package Leaflet. Patients need to receive a loading dose on the first day of treatment. The aim of the loading dose is to reach ‘steady state’ (stable) blood levels. The loading dose is then followed by a maintenance dose that can be adjusted according to the patient’s response. There is no need of a loading dose in children aged between 2 and 12 years.
Both the loading and the maintenance dose can be given by infusion or orally, using either the tablets or the suspension, but the use of the suspension is recommended in children aged between 2 and 12 years. The tablets and suspension are to be taken at least one hour before, or one hour following, a meal.

How does it work?

The active substance in VFEND, voriconazole, is an antifungal medicine that belongs to the group of the triazoles. It works by preventing the formation of ergosterol, which is an important part of fungal cell membranes. Without ergosterol, the fungus is killed or prevented from spreading. The list of fungi against which VFEND is active can be found in the Summary of Product Characteristics.

How has it been studied?

The study of VFEND in invasive aspergillosis involved 277 immunocompromised patients (their immune system was not working properly). VFEND was compared with amphotericin B (another antifungal medicine). The study of VFEND in candidaemia (370 patients) compared VFEND with a treatment of amphotericin B followed by fluconazole. VFEND has also been studied in serious refractory Candida infections (55 patients), in scedosporiosis (38 patients) and in fusariosis (21 patients) . Most patients receiving VFEND treatment for these rare infections did not tolerate or did not respond to prior treatment with other antifungal therapy. VFEND has also been studied in 61 children. The main measure of effectiveness in all studies was complete or partial response to treatment.

What benefits has it shown during the studies?

In invasive aspergillosis, the percentage of patients responding to treatment was higher with VFEND than with amphotericin B (53% versus 31%). The survival for voriconazole was significantly greater than that for amphotericin B. For candidaemia, the percentage of responders to VFEND treatment at the end of therapy was the same as for the comparator (72%). A successful outcome was seen in 24/55 (43.6%) subjects with serious refractory Candida infections. In most of these (15/24), the response was complete. In the treatment of scedosporiosis and fusariosis, the overall response was 28/59 patients.

What is the risk associated?

The most commonly reported side effects are visual disturbances, fever, rash, nausea, vomiting, diarrhoea, headache, and swelling of the extremities. Stomach pains and changes in stools should be reported to a doctor. For the full list of all side effects reported with VFEND, please see the Package Leaflet.
VFEND should not be used in people who may be hypersensitive (allergic) to voriconazole or any of the other ingredients. VFEND should not be used in patients who are taking any of the following medicines:

Why has it been approved?

The Committee for Medicinal products for Human Use (CHMP) decided that VFEND’s benefits are greater than its risks for treatment of serious fungal infections, especially in patients with life-threatening infection. They recommended that VFEND be given marketing authorisation.