Briviact 10mgml oral solution

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Brivaracetam

제공처:

UCB Pharma Ltd

ATC 코드:

N03AX23

INN (국제 이름):

Brivaracetam

복용량:

10mg/1ml

약제 형태:

Oral solution

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 04080100; GTIN: 5015313013666

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BRIVIACT 10MG/ML ORAL SOLUTION
brivaracetam
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Briviact is and what it is used for
2.
What you need to know before you take Briviact
3.
How to take Briviact
4.
Possible side effects
5.
How to store Briviact
6.
Contents of the pack and other information
1.
WHAT BRIVIACT IS AND WHAT IT IS USED FOR
What Briviact is
Briviact contains the active substance brivaracetam. It belongs to a
group of medicines called
‘anti-epileptics’. These medicines are used to treat epilepsy.
What Briviact is used for
Briviact is used in adults and adolescents from 16 years of age to
treat a type of epilepsy characterized
by the occurrence of partial seizures with or without secondary
generalization’. 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 given this
medicine to lower the number of fits (seizures) you have. Briviact is
used together with other
medicines for epilepsy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRIVIACT
DO NOT TAKE BRIVIACT IF:
-
you are allergic to brivaracetam, other pyrrolidone derivatives or any

제품 특성 요약

OBJECT 1
BRIVIACT 10 MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 25-Apr-2017 | UCB Pharma
Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Briviact 10 mg/ml oral solution
2. Qualitative and quantitative composition
Each ml contains 10 mg brivaracetam.
Excipient(s) with known effect:
Each ml of oral solution contains 239.8 mg sorbitol (E420), 1mg methyl
parahydroxybenzoate (E218) and
1.16 mg sodium.
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 adult and adolescent patients from 16
years of age with epilepsy.
4.2 Posology and method of administration
Posology
The recommended starting dose is either 50 mg/day or 100 mg/day based
on physician 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.
_Missed doses_
If patients missed one dose or more, it is recommended that they take
a single dose as soon as they
remember and take the following dose at the usual morning or evening
time. This may avoid the
brivaracetam plasma concentration falling below the efficacy level and
prevent breakthrough seizures
from occurring.
_Discontinuation_
If brivaracetam has to be discontinued it is recommended to withdraw
it gradually by 50 mg/day on a
weekly basis. After 1 week of treatment at 50 mg/day, a final week of
treatment at the dose of 20 mg/day