Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
vigabatrin
ORPHELIA Pharma SAS
N03AG04
vigabatrin
Antiepileptics,
Spasms, Infantile; Epilepsies, Partial
Kigabeq is indicated in infants and children from 1 month to less than 7 years of age for:Treatment in monotherapy of infantile spasms (West's syndrome).Treatment in combination with other antiepileptic medicinal products for patients with resistant partial epilepsy (focal onset seizures) with or without secondary generalisation, that is where all other appropriate medicinal product combinations have proved inadequate or have not been tolerated.
Revision: 5
Authorised
2018-09-20
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE USER KIGABEQ 100 MG SOLUBLE TABLETS For children aged 1 month to less than 7 years KIGABEQ 500 MG SOLUBLE TABLETS For children aged 1 month to less than 7 years vigabatrin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU GIVE THIS MEDICINE TO YOUR CHILD BECAUSE IT CONTAINS IMPORTANT INFORMATION. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your child’s doctor or pharmacist. - This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child’s. - If your child gets any side effects, talk to your child’s doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Kigabeq is and what it is used for 2. What you need to know before your child takes Kigabeq 3. How to give Kigabeq 4. Possible side effects 5. How to store Kigabeq 6. Contents of the pack and other information 1. WHAT KIGABEQ IS AND WHAT IT IS USED FOR Kigabeq contains vigabatrin and it is used for treating infants and children aged from 1 month to less than 7 years. It is used to treat infantile spasms (West’s syndrome) or, together with other epilepsy medicines to treat partial epilepsy that is not controlled well enough with current treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOUR CHILD TAKES KIGABEQ _ _ DO NOT GIVE KIGABEQ: - if your child is allergic to vigabatrin or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your child’s doctor before you give Kigabeq if your child: - has or has had depression or any other psychiatric illness in the past - has had any kidney problems as he/she could develop symptoms like sedation or confusion - has had any eye problems . Visual field loss (loss of sight from the edges of your child’s field of vision) may occur during treatment with vigabatrin. You should discuss this possibility w Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Kigabeq 100 mg soluble tablets Kigabeq 500 mg soluble tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Kigabeq 100 mg soluble tablets Each soluble tablet contains 100 mg vigabatrin. Kigabeq 500 mg soluble tablets Each soluble tablet contains 500 mg vigabatrin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Soluble tablet White oval tablets. The tablets are scored on one side and can be divided into equal doses. - 500 mg tablet size: 16.0 mm x 9.0 mm - 100 mg tablet size: 9.4 mm x 5.3 mm 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kigabeq is indicated in infants and children from 1 month to less than 7 years of age for: - Treatment in monotherapy of infantile spasms (West's syndrome). - Treatment in combination with other antiepileptic medicinal products for patients with resistant partial epilepsy (focal onset seizures) with or without secondary generalisation, that is where all other appropriate medicinal product combinations have proved inadequate or have not been tolerated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Vigabatrin 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 neurology. Posology _Monotherapy for infantile spasms (West’s Syndrome) _ _ _ The recommended starting dose is 50 mg/kg/day. Subsequent dosing can be titrated by 25 mg/kg/day increments every 3 days up to the maximum recommended dose of 150 mg/kg/day. Doses of vigabatrin should be given twice daily according to the table below. _ _ _ _ 3 TABLE 1: NUMBER OF SOLUBLE TABLETS ACCORDING TO BODY WEIGHT, STARTING DOSE AND DOSE INCREMENT IN INFANTILE SPASMS _ _ BODY WEIGHT (KG) STARTING DOSE OF 50 MG/KG/DAY PROPOSED DOSES FOR FIRST TITRATION STEP (75 MG/KG/DAY) (DAY 3) PROPOSED DOSES FOR SECOND TITRATION STEP (100 MG/KG/DAY) (DAY 6) 3 0.5 x 100 mg tablet morning 1 x 100 mg tablet Aqra d-dokument sħiħ