SABRILAN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

VIGABATRIN

Available from:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

ATC code:

N03AG04

Pharmaceutical form:

FILM COATED TABLETS

Composition:

VIGABATRIN 500 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

Therapeutic group:

VIGABATRIN

Therapeutic area:

VIGABATRIN

Therapeutic indications:

Treatment in combination with other anti epileptic drugs for patients with resistant partial epilepsy with or without secondary generalisation, that is where all other appropriate drug combinations have proven inadeqate or have not been tolerated.

Authorization date:

2022-10-31

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
Sabrilan 500 mg, film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500mg vigabatrin
For a full list of excipients, see Section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablets.
White to off-white, oval, biconvex tablets with a score line on one
side and “SABRIL” engraved on the other
side. The score line is only to facilitate breaking for ease of
swallowing and not to divide into equal doses.
Visual field defects (VFD) have been reported in patients receiving
vigabatrin with a high prevalence (about
1/3 of patients). Frequencies found in an open- clinical study are
presented in section 5.1. The onset is usually
after months to years of vigabatrin therapy. The degree of visual
field restriction may be severe. Most of the
patients with perimetry-confirmed defects have been asymptomatic.
Hence, this undesirable effect can only be
reliably detected by systematic perimetry which is usually possible
only in patients with a developmental age
of more than 9 years. A specifically developed method based on field
specific Visual Evoked Potentials (VEP)
is available from the company on request to test the presence of
peripheral vision in children aged 3 years and
above. At present this method has not been validated in the detection
of vigabatrin-attributed visual field
defects. Electroretinography may be useful but should be used only in
adults who are unable to cooperate with
perimetry or in the very young (see Visual Field Defects).
Available data suggests that visual field defects are irreversible
even after discontinuation of vigabatrin. A
deterioration of VFD after the treatment is discontinued cannot be
excluded.
Therefore, vigabatrin should only be used after a careful assessment
of the balance of benefits and risk
compared with alternatives.
Vigabatrin is not recommended for use in patients with any
pre-existing clinically significant visual field
defect.
Patients should undergo systematic screening examination when s