BRIVIACT ORAL SOLUTION

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BRIVARACETAM

Available from:

NEOPHARM LTD, ISRAEL

ATC code:

N03AX23

Pharmaceutical form:

SOLUTION (ORAL)

Composition:

BRIVARACETAM 10 MG / 1 ML

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

UCB PHARMA S.A., BELGIUM

Therapeutic area:

BRIVARACETAM

Therapeutic indications:

Briviact is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.

Authorization date:

2022-12-31

Patient Information leaflet

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS)- 1986
This medicine is to be supplied upon a physician's prescription only
BRIVIACT ORAL SOLUTION
ACTIVE INGREDIENT:
BRIVIACT ORAL SOLUTION CONTAINS 10 mg brivaracetam per 1 ml of
solution.
For the list of excipients and allergens in the medicine, please see
chapter 2 section:
“Important information regarding some of the ingredients of the
medicine” and chapter 6:
“Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THE MEDICINE.
This leaflet
contains concise information about the medicine. If you have any
further questions, contact
the physician or the pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if it seems to you that their medical condition is
similar.
This medicine is intended for adults, adolescents and children from 4
years of age.
1. WHAT IS THE MEDICINE INTENDED FOR
?
Briviact is indicated as adjunctive therapy in the treatment of
partial onset seizures
with or without secondary generalisation in adults, adolescents and
children from 4
years of age with epilepsy.
Partial seizures are fits that start by only affecting one side of the
brain. These partial
seizures can spread and extend to larger areas on both sides of the
brain – this is
called a ‘secondary generalisation’.
You have been prescribed this medicine to lower the number of seizures
you have.
Briviact is used together with other medicines to treat epilepsy.
THERAPEUTIC GROUP: anti-epileptics.
2. BEFORE USING THIS MEDICINE
DO NOT TAKE BRIVIACT IF:
-
You are hypersensitive (allergic) to the active ingredient
brivaracetam, other
similar chemical compounds as levetiracetam or piracetam or any of the
other
ingredients of this medicine (listed in chapter 6). If you are not
sure, talk to your
physician or pharmacist before taking Briviact.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE
Talk to your physician or pharmacist before taking Briviact if:
-

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Briviact oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 10 mg brivaracetam.
Excipient(s) with known effect
Each ml of oral solution contains 168 mg sorbitol (E420), 1 mg methyl
parahydroxybenzoate (E218)
and maximum 5.5 mg propylene glycol (E1520).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution
Slightly viscous, clear colourless to yellowish liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Briviact is indicated as adjunctive therapy in the treatment of
partial-onset seizures with or without
secondary generalisation in adults, adolescents and children from 4
years of age with epilepsy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The physician should prescribe the most appropriate formulation and
strength according to weight and
dose. It is recommended to parent and care giver to administer
Briviact oral solution with the
measuring device (10 ml or 5 ml oral dosing syringe) provided in the
carton box.
_Adults _
The recommended starting dose is either 50 mg/day or 100 mg/day based
on physician's assessment of
required seizure reduction versus potential side effects. The dose
should be administered in two
equally divided doses, once in the morning and once in the evening.
Based on individual patient
response and tolerability, the dose may be adjusted in the dose range
of 50 mg/day to 200 mg/day.
_ _
_Children (from 4 years of age) and a_
_dolescents weighing 50 kg or more _
The recommended starting dose is 50mg/day. Brivaracetam may also be
initiated at 100 mg/day based
on physician's assessment of need for seizure control. The dose should
be administered in two equally
divided doses, once in the morning and once in the evening.The
recommended maintenance dose is
100 mg/day. Based on individual patient response, the dose may be
adjusted in the effective dose
range of 50 mg/day to 200 mg/day.
_ _
_Children (from 4 years of age) and adolescents weighing less than 50