Brabio 40mg/1ml solution for injection pre-filled syringes

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Glatiramer acetate

Dostupno od:

Viatris UK Healthcare Ltd

ATC koda:

L03AX13

INN (International ime):

Glatiramer acetate

Doziranje:

40mg/1ml

Farmaceutski oblik:

Solution for injection

Administracija rute:

Subcutaneous

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 08020400; GTIN: 5016695007472

Uputa o lijeku

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
BRABIO 40 MG/ML SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
glatiramer acetate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Brabio is and what it is used for
2.
What you need to know before you use Brabio
3.
How to use Brabio
4.
Possible side effects
5.
How to store Brabio
6.
Contents of the pack and other information
1. WHAT BRABIO IS AND WHAT IT IS USED FOR
Brabio is a medicinal product, administered 3 times a week, which
modifies the way in which your
body's immune system works (it is classed as an immunomodulating
agent). The symptoms of
multiple sclerosis (MS) are thought to be caused by a defect in the
body's immune system. This
produces patches of inflammation in the brain and spinal cord.
Brabio is used to reduce the number of times you suffer attacks of MS
(relapses). It has not been
demonstrated to help if you have any form of MS which does not have
relapses, or hardly any
relapses. Brabio may not have any effect on the length of time an MS
attack lasts, or how badly you
suffer during an attack.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BRABIO
DO NOT USE BRABIO

If you are ALLERGIC TO GLATIRAMER ACETATE OR ANY OF THE OTHER
INGREDIENTS of this medicine (listed
in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Brabio

if you have any KIDNEY OR HEART PROBLEMS as you may need to have
regular tests and check-ups.
CHILDREN
Brabio is not to be used in children below the age of 18 years.

Svojstava lijeka

OBJECT 1
BRABIO 40 MG/ML SOLUTION FOR INJECTION, PRE-
FILLED SYRINGE
Summary of Product Characteristics Updated 08-May-2018 | Generics UK
T/A Mylan
1. Name of the medicinal product
Brabio 40 mg/mL solution for injection, pre-filled syringe
2. Qualitative and quantitative composition
1 ml of solution for injection contains 40 mg glatiramer acetate*,
equivalent to 36 mg of glatiramer base
per pre-filled syringe.
* Glatiramer acetate is the acetate salt of synthetic polypeptides,
containing four naturally occurring
amino acids: L-glutamic acid, L-alanine, L tyrosine and L-lysine, in
molar fraction ranges of 0.129-0.153,
0.392-0.462, 0.086-0.100 and 0.300-0.374, respectively. The average
molecular weight of glatiramer
acetate is in the range of 5,000-9,000 daltons.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection, pre-filled syringe [Solution for injection]
Clear colourless to slightly yellow/brownish solution free from
visible particles.
The solution for injection has a pH of 5.5 - 7.0 and an osmolarity of
about 300 mOsmol/L.
4. Clinical particulars
4.1 Therapeutic indications
Glatiramer acetate is indicated for the treatment of relapsing forms
of multiple sclerosis (MS) (see section
5.1 for important information on the population for which efficacy has
been established).
Glatiramer acetate is not indicated in primary or secondary
progressive MS.
4.2 Posology and method of administration
_Posology_
The recommended dosage in adults is 40 mg of glatiramer acetate (one
pre-filled syringe), administered
as a subcutaneous injection three times a week with at least 48 hours
apart.
At the present time, it is not known for how long the patient should
be treated.
A decision concerning long term treatment should be made on an
individual basis by the treating
physician.
_Paediatric population_
Children and adolescents: No clinical trials or pharmacokinetic
studies have been conducted in children
or adolescents for glatiramer acetate. There is not enough information
available on th