SABRIL Film-coated tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Sabril 500 mg film-coated tablets.
Qualitative and quantitative composition
Each tablet contains 500mg vigabatrin. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. White to off-white, oval, biconvex, tablets with a break-line on one side and Sabril engraved on the other side. The scoreline is only to facilitate breaking for ease of swallowing ...
Therapeutic indications
Treatment in combination with other antiepileptic medicinal products for patients with resistant partial epilepsy with or without secondary generalisation, that is where all other appropriate medicinal ...
Posology and method of administration
Sabril treatment may only be initiated by a specialist in epileptology, neurology or paediatric neurology. Follow-up should be arranged under supervision of a specialist in epileptology, neurology or paediatric ...
Contraindications
Hypersensitivity to vigabatrin or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Except for the treatment of infantile spasms, Sabril should not be initiated as monotherapy. Visual field defects (VFD) have been reported in patients receiving vigabatrin with a high prevalence (about ...
Interaction with other medicinal products and other forms of interaction
As vigabatrin is neither metabolised, nor protein bound and is not an inducer of hepatic cytochrome P450 drug metabolising-enzymes, interactions with other medicinal products are unlikely. However, during ...
Fertility, pregnancy and lactation
Pregnancy Risk related to epilepsy and antiepileptic medicinal products in general In the offspring of women treated with antiepileptic medication, the prevalence of malformations is two to three times ...
Effects on ability to drive and use machines
As a general rule, patients with uncontrolled epilepsy are not allowed to drive or handle potentially dangerous machinery. In view of the fact that drowsiness has been observed in clinical trials with ...
Undesirable effects
Summary of the safety profile Visual field defects ranging from mild to severe have been reported frequently in patients receiving vigabatrin. Severe cases are potentially disabling. The onset is usually ...
Overdose
Symptoms Vigabatrin overdose has been reported. When provided, doses most commonly were between 7.5 to 30g; however, ingestions up to 90g have been reported. Nearly half of the cases involved multiple ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antiepileptics ATC code: N03AG04 Mechanism of action Vigabatrin is an antiepileptic medicinal product with a clearly defined mechanism of action. Treatment with vigabatrin leads ...
Pharmacokinetic properties
Absorption Vigabatrin is a water soluble compound and it is rapidly and completely absorbed from the gastrointestinal tract. Food administration does not alter the extent of vigabatrin absorption. Time ...
Preclinical safety data
Animal safety studies carried out in the rat, mouse, dog and monkey have indicated that vigabatrin has no significant adverse effects on the liver, kidney, lung, heart or gastrointestinal tract. In the ...
List of excipients
Tablet core: Povidone K30 (E1201) Microcrystalline cellulose (E460) Magnesium stearate Sodium starch glycollate (Type A) Tablet coating: Hypromellose 15 mPa.s (E464) Titanium dioxide (E171) Macrogol 8000 ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 36 months.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Clear colourless PVC-aluminium blisters of 10 film-coated tablets or Opaque blue PVC-aluminium blisters of 10 film-coated tablets. Each blister pack contains 30, 50, 60, 100 or 200 tablets. Not all pack ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire. RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire. RG6 1PT, UK
Marketing authorization number(s)
PL 04425/0171
Date of first authorization / renewal of the authorization
26<sup>th</sup> January 2001/19<sup>th</sup> June 2006
Date of revision of the text
5 March 2020
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