Negara: Afrika Selatan
Bahasa: Inggris
Sumber: South African Health Products Regulatory Authority (SAHPRA)
Sanofi-Aventis South Africa (Pty) Ltd
See ingredients
TABLET
EACH TABLET CONTAINS VIGABATRIN 500 mg
Registered
1995-02-03
sanofi-aventis south africa (pty) ltd Sabril film-coated tablets 500 mg vigabatrin Date of approval: 16/03/2023 Page 1 of 10 PATIENT INFORMATION LEAFLET VISUAL FIELD LOSS (LOSS OF SIGHT FROM THE EDGES OF YOUR FIELD OF VISION) HAS BEEN REPORTED IN ADULTS AND CHILDREN TAKING SABRIL. YOU SHOULD DISCUSS THIS POSSIBILITY WITH YOUR DOCTOR BEFORE YOU BEGIN TREATMENT WITH SABRIL. MALES ARE AT GREATER RISK THAN FEMALES. MOST OF THE PATIENTS WITH CONFIRMED VISUAL DEFECTS DID NOT EXPERIENCE SYMPTOMS. THIS VISUAL FIELD LOSS MAY BE SEVERE, UP TO TUNNEL VISION OR LOSS OF VISION, AND IRREVERSIBLE, SO IT MUST BE FOUND EARLY. A DETERIORATION OF THIS VISUAL FIELD LOSS AFTER TREATMENT IS DISCONTINUED CANNOT BE EXCLUDED. IT IS IMPORTANT THAT YOU INFORM YOUR DOCTOR PROMPTLY IF YOU BECOME AWARE OF ANY CHANGE TO YOUR VISION. YOUR DOCTOR SHOULD PERFORM A VISUAL FIELD EXAMINATION AND VISUAL ACUITY TESTING BEFORE YOU START TAKING SABRIL AND AT REGULAR INTERVALS DURING THE TREATMENT. YOUR DOCTOR MAY REQUIRE FROM YOU TO SIGN A FORM TO ACKNOWLEDGE THAT THIS RISK ASSOCIATED WITH THE USE OF SABRIL HAS BEEN DISCUSSED WITH YOU. SABRIL MAY CAUSE REDUCED VISION DUE TO EYE PROBLEMS SUCH AS RETINAL DISORDER, BLURRED VISION, OPTIC ATROPHY OR OPTIC NEURITIS (SEE SECTION 4). IF YOUR VISION CHANGES CONSULT YOUR OPHTHALMOLOGIST. SCHEDULING STATUS: S3 SABRIL TABLETS FILM-COATED TABLETS Vigabatrin Sugar free sanofi-aventis south africa (pty) ltd Sabril film-coated tablets 500 mg vigabatrin Date of approval: 16/03/2023 Page 2 of 10 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING SABRIL • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor, pharmacist, nurse or other health care provider. • SABRIL has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT IS IN THIS LEAFLET 1. What SABRIL is and what it is used for 2. What you need to know before you use SABRIL 3. How to use SABRIL 4 Baca dokumen lengkapnya
sanofi-aventis south africa (pty) ltd Sabril film-coated tablets 500 mg vigabatrin Date of approval: 16/03/2023 Page 1 of 16 PROFESSIONAL INFORMATION FOR SABRIL VISUAL FIELD DEFECTS HAVE BEEN REPORTED IN PATIENTS RECEIVING SABRIL WITH A HIGH PREVALENCE (ABOUT ONE THIRD OF PATIENTS). MALES MAY BE AT GREATER RISK THAN FEMALES. MOST OF THE PATIENTS WITH PERIMETRY-CONFIRMED DEFECTS WERE ASYMPTOMATIC. AVAILABLE EVIDENCE SUGGESTS THAT VISUAL FIELD DEFECTS (VFD) ARE IRREVERSIBLE EVEN AFTER DISCONTINUATION OF SABRIL. DETERIORATION OF VFD AFTER THE TREATMENT IS DISCONTINUED CANNOT BE EXCLUDED. ALL PATIENTS SHOULD HAVE OPHTHALMOLOGICAL CONSULTATION WITH VISUAL FIELD EXAMINATION BEFORE THE INITIATION OF SABRIL TREATMENT AND AT SIX-MONTH INTERVALS. THE PRESCRIBER IS ADVISED TO ENSURE THAT THE PATIENT CONSENT FORM HAS BEEN SIGNED, PRIOR TO ISSUE OF A PRESCRIPTION FOR SABRIL. SCHEDULING STATUS S3 1. NAME OF THE MEDICINE SABRIL TABLETS Film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg vigabatrin. Sugar free. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets White to off-white, oval, biconvex tablet with a break line on one side and SABRIL inscribed on the other. sanofi-aventis south africa (pty) ltd Sabril film-coated tablets 500 mg vigabatrin Date of approval: 16/03/2023 Page 2 of 16 The break line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment in combination with other anti-epileptic medicines for patients with resistant partial epilepsy with or without secondary generalisation, that is where all other appropriate medicine combinations have proved inadequate or have not been tolerated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY SABRIL treatment should only be initiated by a specialist in neurology, paediatric neurology or paediatricians who treat patients with epilepsy for which SABRIL is indicated. Follow-up should be arranged und Baca dokumen lengkapnya