Vimpat 10 mg/ml solution for infusion Lacosamide - United Kingdom[英国药品]

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Vimpat 10 mg/ml solution for infusion Lacosamide

2014-06-03 23:08:09 来源: 作者: 【大中小】浏览:342次评论:0条

For doctors

What is it and how is it used?

Vimpat is used to treat a certain form of epilepsy (see below) in patients aged 16 years and older. Vimpat is used in addition to other antiepileptic medicines.
Epilepsy is a condition where the patients have repeated fits (seizures). Vimpat is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation).

Vimpat solution for infusion is an alternative form of treatment for a short period of time, when oral (by mouth) administration is not possible.

What do you have to consider before using it?

Do NOT take Vimpat

Take special care with Vimpat
Please inform your doctor about the following:

Vimpat may cause dizziness, which could increase the risk of accidental injury or a fall. Therefore, you should be careful until you are used to the effects this medicine might have.

A small number of people being treated with anti-epileptics such as lacosamide have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important if you take medicines to treat heart problems (see also above "Take special care").

Using Vimpat with food and drink
You may take Vimpat with or without food.
It is not advisable to drink alcohol while you are under treatment with Vimpat, because Vimpat could make you feel tired or dizzy. Drinking alcohol could make these effects worse.

Pregnancy and breast-feeding
It is not recommended to take Vimpat if you are pregnant, as the effects of Vimpat on pregnancy and the unborn baby are not known. Tell your doctor immediately if you are pregnant or planning to become pregnant; he/she will decide if you should take Vimpat.

It is not recommended to breast-feed your baby while taking Vimpat, as it is not known if Vimpat passes into the breast milk. If you are breast-feeding, please inform your doctor immediately; he/she will decide if you should take Vimpat.

Research has shown an increased risk of birth defects in children of women taking anti-epileptic medicines. On the other hand effective anti-epileptic therapy must not be interrupted since the worsening of the disease is harmful to both the mother and the unborn child.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Vimpat may cause dizziness or blurred vision. This may affect your ability to drive or operate any tools or machinery. You should not drive or use machines until you know whether this medicine affects your ability to perform these activities.

Important information about some of the ingredients of Vimpat
This medicinal product contains 2.6 mmol (or 59.8 mg) sodium per vial. To be taken into consideration for patients on a controlled sodium diet.

How is it used?

The solution for infusion is an alternative form of treatment for a short period of time, when Vimpat can't be taken by mouth. It will be administered into a vein by a health care professional. It is possible to switch directly from oral administration to infusion and the other way around. Your total daily dose and frequency of administration remain the same.

Dosage
Vimpat must be administered twice a day, once in the morning and once in the evening, at about the same time each day.
The treatment with Vimpat starts usually with a dose of 100 mg daily given half (50 mg) in the morning and half (50 mg) in the evening. The daily maintenance dose is between 200 mg and 400 mg. Your doctor may use a different dose if you have problems with your kidneys.

How Vimpat is given to you
Vimpat is administered as an infusion into a vein (intravenously) by a healthcare professional. It is infused over 15-60 minutes.

Duration of the treatment with Vimpat solution for infusion
Your doctor will decide for how many days you will receive the infusions. There is experience with twice daily infusions of Vimpat up to 5 days. For the long term treatment Vimpat tablets and syrup are available.

If you stop using VimpatIf your doctor decides to stop your treatment with Vimpat, he/she will decrease the dose step by step. This is to prevent your symptoms from coming back again or becoming worse.

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

What are possible side effects?

Like all medicines, Vimpat can cause side effects, although not everybody gets them.

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data)

Very common: affects more than 1 user in 10

Common: affects 1 to 10 users in 100

Uncommon: affects 1 to 10 users in 1000

Intravenous administration
Intravenous administration was associated with local side effects such as :
Common: affects 1 to 10 users in 100

Uncommon: affects 1 to 10 users in 1,000

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 Vimpat after the expiry date which is stated on the carton and vial. The expiry date refers to the last day of that month.
Do not store above 25°C.
Each vial of Vimpat solution for infusion must be used only once (single use). Any unused solution should be discarded.
Only clear solution free from particles and discoloration should be used.
Medicines should not be disposed of via wastewater or household 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?

Vimpat is a medicine containing the active substance lacosamide. It is available as oval tablets (pink: 50 mg; yellow: 100 mg; salmon: 150 mg; blue: 200 mg), as a syrup (15 mg/ml) and as a solution for infusion (drip into a vein, 10 mg/ml).

What is it used for?

Vimpat is used to treat partial-onset seizures (epileptic fits starting from one specific part of the brain) as an add-on to other antiepileptic medicines in patients with epilepsy aged 16 years and older. It can be used in patients with partial-onset seizures with or without secondary generalisation (where the seizure subsequently spreads to the whole brain).
The medicine can only be obtained with a prescription.

How is it used?

Vimpat is taken twice a day, with or without food. The recommended starting dose is 50 mg twice a day. After one week, the dose should be increased to 100 mg twice a day and then, depending on the patient’s response, it may be further increased every week by 50 mg twice a day to the maximum dose of 200 mg twice a day. A special pack with tablets of all four strengths is available to help when initiating treatment. Lower doses may be used in patients who have problems with their kidneys. If the patient is temporarily unable to take the tablets or syrup, Vimpat can be given at the same dose as an infusion lasting 15 minutes to one hour. This should only be used for a few days.

How does it work?

The active substance in Vimpat, lacosamide, is an anti-epileptic medicine. Epilepsy is caused by excessive electrical activity in the brain. The exact way in which lacosamide works is still unclear but it seems to reduce the activity of sodium channels (pores on the surface of nerve cells) that allow electrical impulses to be transmitted between nerve cells. Lacosamide is also thought to be involved in the development of nerve cells that have been damaged. Together, these actions may prevent abnormal electrical activity spreading through the brain, reducing the chance of an epileptic fit happening.

How has it been studied?

The effects of Vimpat were first tested in experimental models before being studied in humans.

The effectiveness of Vimpat taken by mouth has been compared with that of placebo (a dummy treatment) in three main studies involving a total of 1,308 patients. Patients added Vimpat at a dose of 200 mg, 400 mg or 600 mg a day, or placebo to their existing treatment of up to three other anti-epileptic medicines. The main measure of effectiveness was the number of patients whose number of seizures was at least halved after 12 weeks of treatment with a stable dose.
Two additional studies looked at the appropriate duration of the infusion for Vimpat solution and compared its safety with that of placebo infusions in a total of 199 patients.

What benefits has it shown during the studies?

Vimpat, at doses of 200 or 400 mg a day, was more effective than placebo in reducing the number of seizures. Looking at the results of the three main studies taken together, 34% of the patients adding Vimpat 200 mg/day and 40% of the patients adding Vimpat 400 mg/day to their existing treatment achieved at least a 50% reduction in the number of seizures. This was compared with 23% of the patients adding placebo. The 600-mg dose was as effective as the 400-mg dose, but it had more side effects.

What is the risk associated?

The most common side effects with Vimpat (seen in more than 1 patient in 10) are dizziness, headache, diplopia (double vision) and nausea (feeling sick). For the full list of all side effects reported with Vimpat, see the Package Leaflet.
Vimpat should not be used in people who may be hypersensitive (allergic) to lacosamide or any of the other ingredients, or who have second or third degree AV block (a type of heart rhythm disorder). Vimpat tablets must not be used in people who are hypersensitive to peanut or soya.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Vimpat’s benefits are greater than its risks when used as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. The Committee recommended that Vimpat be given marketing authorisation.