BRABIO Solution for injection (2021)

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Περιεχόμενα

1. Name of the medicinal product

Brabio 20 mg/mL Solution for Injection, Pre-filled Syringe.

2. Qualitative and quantitative composition

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 ...

3. 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.

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 ...

4.2. Posology and method of administration

The initiation of glatiramer acetate treatment should be supervised by a neurologist or a physician experienced in the treatment of MS. Posology The recommended dosage in adults is 20 mg of glatiramer ...

4.3. Contraindications

Glatiramer acetate is contraindicated under the following conditions: Hypersensitivity to the active substance (glatiramer acetate) or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Glatiramer acetate should only be administered subcutaneously. Glatiramer acetate should not be administered by intravenous or intramuscular routes. The treating physician should explain to the patient ...

4.5. Interaction with other medicinal products and other forms of interaction

Interaction between glatiramer acetate and other medicinal products have not been formally evaluated. Observations from existing clinical trials and post-marketing experience do not suggest any significant ...

4.6. Pregnancy and lactation

Pregnancy Studies in animals have not shown reproductive toxicity (see section 5.3). Current data on pregnant women indicate no malformative or feto/neonatal toxicity of glatiramer acetate. To date, no ...

4.7. Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8. Undesirable effects

In all clinical trials, injection-site reactions were seen to be the most frequent adverse reactions and were reported by the majority of patients receiving glatiramer acetate. In controlled studies, the ...

4.9. Overdose

Symptoms A few cases of overdose with glatiramer acetate (up to 300 mg glatiramer acetate) have been reported. These cases were not associated with any adverse reactions other than those mentioned in section ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Other immunostimulants ATC code: L03AX13 Mechanism of action The mechanism by which glatiramer acetate exerts therapeutic effects in relapsing forms of MS is not ...

5.2. Pharmacokinetic properties

Pharmacokinetic studies in patients have not been performed. In vitro data and limited data from healthy volunteers indicate that with subcutaneous administration of glatiramer acetate, the active ...

5.3. Preclinical safety data

Non clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotocixity, carcinogenic potential, toxicity to reproduction, beyond ...

6.1. List of excipients

Mannitol Water for injections

6.2. Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store in the original package in order to protect from light. Store in a refrigerator (2°C to 8°C). Do not freeze. If the pre-filled syringes cannot be stored in a refrigerator, they can be stored between ...

6.5. Nature and contents of container

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 ...

6.6. Special precautions for disposal and other handling

For single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

8. Marketing authorization number(s)

PL 04569/1725

9. Date of first authorization / renewal of the authorization

05 April 2016

10. Date of revision of the text

13 October 2021

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