Pays: Singapour
Langue: anglais
Source: HSA (Health Sciences Authority)
VIGABATRIN
SANOFI-AVENTIS SINGAPORE PTE. LTD.
N03AG04
500 mg
TABLET, FILM COATED
VIGABATRIN 500 mg
ORAL
Prescription Only
Patheon France
ACTIVE
1994-12-09
SABRIL ® 500MG Vigabatrin Film-coated tablet [sanofi aventis logo] COMPOSITION Each film-coated tablet contains : vigabatrin (active ingredient) 500mg – Other excipients : microcrystalline cellulose, povidone, sodium, starch glycolate, magnesium stearate, hypromellose, titanium dioxide, Macrogol 8000. INDICATIONS Treatment in combination with other anti-epileptic drugs for patients with resistant partial epilepsy with or without secondary generalization, that is where all other appropriate drug combinations have proved inadequate or have not been tolerated. POSOLOGY AND METHOD OF ADMINISTRATION SABRIL treatment may only be initiated by a specialist in epileptology, neurology. Follow-up should be arranged under supervision of a specialist in epileptology, neurology or paediatric neurology. SABRIL is for oral administration once or twice daily and may be taken before or after meals. Tablets are swallowed with half a glass of water. If the control of epilepsy is not clinically significantly improved after an adequate trial, vigabatrin treatment should be discontinued. Vigabatrin should be gradually withdrawn under close medical supervision. The tablet form is not suitable for children aged less than 6 years due to the risk of choking. ADULTS: Maximal efficacy is usually seen in the 2 – 3g/day range. A starting dose of 1g daily should be added to the patient’s current anti-epileptic drug regimen. The daily dose should then be titrated in 0.5g increments at weekly intervals depending on clinical response and tolerability. The highest recommended dose is 3g/day. No direct correlation exists between the plasma concentration and the efficacy. The duration of the effect of the drug is dependent on the rate of GABA transaminase resynthesis rather than the concentration of the drug in the plasma (see also Sections Properties and Pharmacokinetic Lire le document complet
SG/SAB/0621/CCDSv14 SABRIL ® 500MG Vigabatrin Film-coated tablet [sanofi aventis logo] COMPOSITION Each film-coated tablet contains : vigabatrin (active ingredient) 500mg – Other excipients : microcrystalline cellulose, povidone, sodium, starch glycolate, magnesium stearate, hypromellose, titanium dioxide, Macrogol 8000. INDICATIONS Treatment in combination with other anti-epileptic drugs for patients with resistant partial epilepsy with or without secondary generalization, that is where all other appropriate drug combinations have proved inadequate or have not been tolerated. POSOLOGY AND METHOD OF ADMINISTRATION SABRIL treatment may only be initiated by a specialist in epileptology, neurology. Follow-up should be arranged under supervision of a specialist in epileptology, neurology or paediatric neurology. SABRIL is for oral administration once or twice daily and may be taken before or after meals. Tablets are swallowed with half a glass of water. If the control of epilepsy is not clinically significantly improved after an adequate trial, vigabatrin treatment should be discontinued. Vigabatrin should be gradually withdrawn under close medical supervision. The tablet form is not suitable for children aged less than 6 years due to the risk of choking. ADULTS: Maximal efficacy is usually seen in the 2 – 3g/day range. A starting dose of 1g daily should be added to the patient’s current anti-epileptic drug regimen. The daily dose should then be titrated in 0.5g increments at weekly intervals depending on clinical response and tolerability. The highest recommended dose is 3g/day. No direct correlation exists between the plasma concentration and the efficacy. The duration of the effect of the drug is dependent on the rate of GABA transaminase resynthesis rather than the concentration of the drug in the plasma (see also Sections Properties and Pharmacokinetic properties). CHILDREN: The recommended starting dose in children is 40mg/kg/day. Maintenance recommendations in relation to bodyweight are: Bodyweight: 10- Lire le document complet