Land: Ísrael
Tungumál: enska
Heimild: Ministry of Health
NUSINERSEN
MEDISON PHARMA LTD
SOLUTION FOR INJECTION
NUSINERSEN 2.4 MG / 1 ML
INTRATHECAL
Required
BIOGEN NETHERLANDS B.V
Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy except type 0 and type IV.
2019-08-19
1 PHYSICIAN PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT SPINRAZA Solution for injection 2. 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. 3. PHARMACEUTICAL FORM Solution for injection. Clear and colourless solution with pH of approximately 7.2. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy except type 0 and type IV . 4.2 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 of the expected benefits of treatment for that individual, balanced against the potential risk of treatment with Spinraza. Patients with profound hypotonia and respiratory failure at birth, where Spinraza has not been studied, may not experience a clinically meaningful benefit due to severe survival motor neuron (SMN) protein deficiency. Posology Spinraza is for intrathecal use by lumbar puncture. The recommended dosage is 12 mg (5 ml) per administration. Spinraza treatment should be initiated as early as possible after diagnosis with 4 loading doses on Days 0, 14, 28 and 63. A maintenance dose should be administered once every 4 months thereafter. _ _ _Duration of treatment _ Information on long term efficacy of this medicinal product is not available. The need for continuation of therapy should be reviewed regularly and considered on an individual basis depending on the patient’s clinical presentation and response to the thera py. 2 _Missed or delayed doses _ If a loading dose is delayed or missed Spinraza should be administered as soon as possible, with at least 14 days between doses, and continue dosing at the prescribed frequency. If a maintenance dose is delayed or missed, Spinraza should be administered Lestu allt skjalið