Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Brabio 20 mg/mL Solution for Injection, Pre-filled Syringe.
| Pharmaceutical Form |
|---|
|
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 265 mOsmol/L. |
1 pre-filled syringe (1 ml) of solution for injection contains 20 mg glatiramer acetate*, equivalent to 18 mg of glatiramer base.
* 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. Due to its compositional complexity, no specific polypeptide can be fully characterised, including in terms of amino acid sequence, although the final glatiramer acetate composition is not entirely random.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Glatiramer |
Glatiramer is presumed to involve modulation of immune processes. Glatiramer is licensed for reduced frequency of relapses in relapsing-remitting multiple sclerosis. |
| List of Excipients |
|---|
|
Mannitol |
The container closure system consists of a single use glass syringe barrel with an integrated needle. A rubber stopper (bromobutyl, type 1) is fitted in the barrel for closure and acts as a piston during injection. A driving rod is screwed in the rubber stopper. The needle is covered with a needle shield.
The volume of solution in the syringe is 1.0 ml.
7 pre-filled syringes
28 pre-filled syringes
30 pre-filled syringes
90 (3x30) pre-filled syringes
Not all pack sizes may be marketed.
Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
PL 04569/1725
05 April 2016
| Drug | Countries | |
|---|---|---|
| BRABIO | Ireland, United Kingdom |
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