Keppra 100 mg/ml oral solutionPatient’s LeafletSummary for t - United Kingdom[英国药品]

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Keppra 100 mg/ml oral solutionPatient’s LeafletSummary for t

2014-05-28 22:41:36 来源: 作者: 【大中小】浏览:344次评论:0条

For doctors

What is it and how is it used?

Keppra 100 mg/ml oral solution is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Keppra is used:

What do you have to consider before using it?

Do not take Keppra

Take special care with Keppra

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.

Taking Keppra with food and drink
You may take Keppra with or without food. As a safety precaution, do not take Keppra with alcohol.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant or if you think you may be pregnant, please inform your doctor. Keppra should not be used during pregnancy unless clearly necessary. The potential risk to your unborn child is unknown. Keppra has shown unwanted reproductive effects in animal studies at dose levels higher than you would need to control your seizures.
Breast-feeding is not recommended during treatment.

Driving and using machines
Keppra may impair your ability to drive or operate any tools or machinery, as Keppra may make you feel sleepy. This is more likely at the beginning of treatment or after an increase in the dose. You should not drive or use machines until it is established that your ability to perform such activities is not affected.

Important information about some of the ingredients of Keppra
Keppra oral solution includes methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How is it used?

Always take Keppra exactly as your doctor has told you. You should check with your doctor if you are not sure.
Keppra must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Take the oral solution following your doctor’s instructions.

Monotherapy

Dose in adults and adolescents (from 16 years of age):
General dose: between 10 ml (1000 mg) and 30 ml (3,000 mg) each day, divided in 2 intakes per day. When you will first start taking Keppra, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.

Add-on therapy

Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:
General dose: between 10 ml (1,000 mg) and 30 ml (3,000 mg) each day, divided in 2 intakes per day.

Dose in infants (6 to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:
General dose: between 0.2 ml (20 mg) and 0.6 ml (60 mg) per kg bodyweight each day, divided in 2 intakes per day. The exact quantity of oral solution formulation should be delivered using either the 3 ml syringe with 0.1 ml graduations or the 10 ml syringe with 0.25 ml graduations, depending on the dose.

Weight Starting dose 0.1 mlkg twice daily Maximum dose 0.3 mlkg twice daily 6 kg 0.6 ml twice daily 1.8 ml twice daily 8 kg 0.8 ml twice daily 2.4 ml twice daily 10 kg 1 ml twice daily 3 ml twice daily 15 kg 1.5 ml twice daily 4.5 ml twice daily 20 kg 2 ml twice daily 6 ml twice daily 25 kg 2.5 ml twice daily 7.5 ml twice daily From 50 kg 5 ml twice daily 15 ml twice daily

Dose in infants (1 month to less than 6 months):
General dose: between 0.14 ml (14 mg) and 0.42 ml (42 mg) per kg bodyweight each day, divided in 2 intakes per day. The exact quantity of oral solution formulation should be delivered using the 1 ml syringe with 0.05 ml graduations.

Weight Starting dose 0.07 mlkg twice daily Maximum dose 0.21 mlkg twice daily 4 kg 0.3 ml twice daily 0.85 ml twice daily 5 kg 0.35 ml twice daily 1.05 ml twice daily 6 kg 0.45 ml twice daily 1.25 ml twice daily 7 kg 0.5 ml twice daily 1.5 ml twice daily

Method of administration:
Keppra oral solution may be diluted in a glass of water.

Instruction for use:

Duration of treatment:

If you take more Keppra than you should:

The possible side effects of an overdose of Keppra are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
Contact your doctor if you took more Keppra than you should. Your doctor will establish the best possible treatment of overdose.

If you forget to take Keppra:
Contact your doctor if you have missed one or more doses.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Keppra:
If stopping treatment, as with other antiepileptic medicines, Keppra should be discontinued gradually to avoid an increase of seizures.

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, Keppra can cause side effects, although not everybody gets them. Tell your doctor if you have any of the following and they worry you.

Some of the side effects like sleepiness, tiredness and dizziness may be more common at the beginning of the treatment or at dose increase. These effects should however decrease over time.

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:

Common:

Not known:

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 after the expiry date stated on the cardboard box and bottle after EXP:. The expiry date refers to the last day of the month.
Do not use after 7 months of first opening the bottle.

Due to sensitivity to light, store in the original container.

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For doctors

What is it?

Keppra is a medicine that contains the active substance levetiracetam. It is available as oblong tablets (blue: 250 mg; yellow: 500 mg; orange: 750 mg; white: 1,000 mg), as an oral solution (100 mg/ml), and as a concentrate that is made up into a solution for infusion (drip into a vein, 100 mg/ml).

What is it used for?

Keppra can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation. This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear. Secondary generalisation occurs when the overactivity later reaches the whole brain.

Keppra can also be used as an add-on to other anti-epileptic medicines to treat:

The medicine can only be obtained with a prescription.

How is it used?

When Keppra is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day. The dose can be further increased at two-week intervals according to the patient’s response, to a maximum dose of 1,500 mg twice a day.

When Keppra is added to another anti-epileptic treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day. The daily dose can be increased up to 1,500 mg twice a day. In patients aged between six months and 17 years weighing less than 50 kg, the starting dose is 10 mg per kilogram body weight twice a day, which can be increased up to 30 mg/kg twice a day. The oral solution is recommended when starting treatment in children weighing less than 20 kg. In babies aged between one and six months, the starting dose is 7 mg/kg twice a day, using the oral solution. This can be increased up to 21 mg/kg twice a day.

Lower doses are used in patients who have problems with their kidneys (such as older patients).

Keppra tablets are swallowed with liquid. The oral solution may be mixed in a glass of water before it is taken. Keppra can be given as an infusion using the same doses at the same frequency when using the tablets or the oral solution is not possible. The use of the infusion should be temporary.

How does it work?

The active substance in Keppra, levetiracetam, is an anti-epileptic medicine. Epilepsy is caused by excessive electrical activity in the brain. The exact way in which levetiracetam works is still unclear but it seems to interfere with a protein called synaptic vesicle protein 2A, which is found in the spaces between nerves and is involved in the release of chemical messengers from nerve cells. This helps Keppra to stabilise electrical activity in the brain and prevent seizures.

How has it been studied?

Keppra used on its own has been studied in 579 patients with partial-onset seizures aged 16 years and over, who received either Keppra or carbamazepine (another anti-epileptic medicine) for up to two years. The study measured how many patients remained free of seizures for six months once they had reached their effective dose.

Keppra has also been studied as an add-on treatment:

In all of these studies, the main measure of effectiveness was the change in the number of seizures before and during treatment.

What benefits has it shown during the studies?

Keppra was as effective as carbamazepine in keeping patients free of seizures when taken on its own for partial onset seizures. In both groups, 73% of the patients experienced no seizures for six months once on an adequate dose.

As an add-on treatment, Keppra was more effective than placebo:

What is the risk associated?

The most common side effects with Keppra (seen in more than 1 patient in 10) are somnolence (sleepiness), and asthenia (weakness) or fatigue (tiredness). For the full list of all side effects reported with Keppra, see the package leaflet.

Keppra should not be used in people who may be hypersensitive (allergic) to levetiracetam, to other pyrrolidone derivatives (medicines with a similar structure to levetiracetam), or to any of the other ingredients.

Why has it been approved?

The CHMP decided that Keppra’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Keppra on 29 September 2000. The marketing authorisation holder is UCB Pharma SA. After 10 years, the marketing authorisation was renewed for a further five years.

For more information about treatment with Keppra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 07-2010.

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