Kigabeq

Land: Europeiska unionen

Språk: engelska

Källa: EMA (European Medicines Agency)

Aktiva substanser:

vigabatrin

Tillgänglig från:

ORPHELIA Pharma SAS

ATC-kod:

N03AG04

INN (International namn):

vigabatrin

Terapeutisk grupp:

Antiepileptics,

Terapiområde:

Spasms, Infantile; Epilepsies, Partial

Terapeutiska indikationer:

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.

Produktsammanfattning:

Revision: 5

Bemyndigande status:

Authorised

Tillstånd datum:

2018-09-20

Bipacksedel

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

Produktens egenskaper

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