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SPC: SPIRANZA Solution for injection (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Spinraza 12 mg solution for injection.

Qualitative and quantitative composition

Each 5 ml vial contains nusinersen sodium equivalent to 12 mg nusinersen. Each ml contains 2.4 mg of nusinersen. For the full list of excipients, see section 6.1.

Pharmaceutical form

Solution for injection. Clear and colourless solution with pH of approximately 7.2.

Therapeutic indications

Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy.

Posology and method of administration

Treatment with Spinraza should only be initiated by a physician with experience in the management of spinal muscular atrophy (SMA). The decision to treat should be based on an individualised expert evaluation ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Lumbar puncture procedure There is a risk of adverse reactions occurring as part of the lumbar puncture procedure (e.g. headache, back pain, vomiting; see section 4.8). Potential difficulties with this ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed. In vitro studies indicated that nusinersen is not an inducer or inhibitor of CYP450 mediated metabolism. In vitro studies indicate that the likelihood for interactions ...

Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of nusinersen in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see ...

Effects on ability to drive and use machines

Spinraza has no or negligible influence on the ability to drive and use machines .

Undesirable effects

Summary of safety profile The safety assessment of Spinraza was based on two Phase 3 clinical studies in infants (CS3B) and children (CS4) with SMA, together with one Phase 2 study in infants and children ...

Overdose

No cases of overdose associated with adverse reactions were reported in clinical studies. In the event of an overdose, supportive medical care should be provided including consulting with a healthcare ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other drugs for disorders of the musculo-skeletal system ATC code: M09AX07 Mechanism of action Nusinersen is an antisense oligonucleotide (ASO) which increases the proportion ...

Pharmacokinetic properties

Single- and multiple-dose pharmacokinetics (PK) of nusinersen, administered via intrathecal injection, were determined in paediatric patients diagnosed with SMA. Absorption Intrathecal injection of nusinersen ...

Preclinical safety data

Carcinogenesis Long-term studies in animals to evaluate the carcinogenic potential of nusinersen have not been performed. Mutagenesis Nusinersen demonstrated no evidence of genotoxicity. Reproductive toxicity ...

List of excipients

Sodium dihydrogen phosphate dihydrate Disodium phosphate Sodium chloride Potassium chloride Calcium chloride dihydrate Magnesium chloride hexahydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Store in a refrigerator (2°C-8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light. If no refrigeration is available, Spinraza may be stored in its original carton, protected ...

Nature and contents of container

5 ml in a Type I glass vial with bromobutyl rubber stopper and an aluminium over-seal and plastic cap. Pack size of one vial per carton.

Special precautions for disposal and other handling

For single use only. Instructions for preparation of the medicinal product before administration: The Spinraza vial should be inspected for particles prior to administration. If particles are observed ...

Marketing authorization holder

Biogen Netherlands B.V., Prins Mauritslaan 13, 1171 LP Badhoevedorp, The Netherlands

Marketing authorization number(s)

EU/1/17/1188/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 30 May 2017

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