Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

biogen - nusinersen (unii: 5z9sp3x666) (nusinersen - unii:5z9sp3x666) - nusinersen 2.4 mg in 1 ml - spinraza is indicated for the treatment of spinal muscular atrophy (sma) in pediatric and adult patients. none. risk summary there are no adequate data on the developmental risk associated with the use of spinraza in pregnant women. when nusinersen was administered by subcutaneous injection to mice throughout pregnancy and lactation, developmental toxicity (long-term neurobehavioral impairment) was observed at all doses tested (see data). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data when nusinersen (0, 3, 10, or 25 mg/kg) was administered subcutaneously to male and female mice every other day prior to and during mating and continuing in females throughout organogenesis, no adverse effects on embryofetal development were observed. subcutaneous administration of nusinersen (0, 6, 12.6, or 25 mg/kg) to pregnant rabbits every other day throughout organogenesis produced no evidence of embryofetal developmental toxicity. when nusinersen (1.4, 5.8, or 17.2 mg/kg) was administered to pregnant female mice by subcutaneous injection every other day throughout organogenesis and continuing once every six days throughout the lactation period, adverse neurobehavioral effects (alterations in locomotor activity, learning and memory deficits) were observed when offspring were tested after weaning or as adults. a no-effect level for neurobehavioral impairment was not established. risk summary there are no data on the presence of nusinersen in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.nusinersen was detected in the milk of lactating mice when administered by subcutaneous injection. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for spinraza and any potential adverse effects on the breastfed infant from spinraza or from the underlying maternal condition. the safety and effectiveness of spinraza in pediatric patients from newborn to 17 years have been established [see clinical studies (14.1)]. juvenile animal toxicity data in intrathecal toxicity studies in juvenile monkeys, administration of nusinersen (0, 0.3, 1, or 3 mg/dose for 14 weeks and 0, 0.3, 1, or 4 mg/dose for 53 weeks) resulted in brain histopathology (neuronal vacuolation and necrosis/cellular debris in the hippocampus) at the mid and high doses and acute, transient deficits in lower spinal reflexes at the high dose in each study. in addition, possible neurobehavioral deficits were observed on a learning and memory test at the high dose in the 53-week monkey study. the no-effect dose for neurohistopathology in monkeys (0.3 mg/dose) is approximately equivalent to the human dose when calculated on a yearly basis and corrected for the species difference in csf volume. clinical studies of spinraza did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

biogen australia pty ltd - nusinersen heptadecasodium, quantity: 12.6 mg (equivalent: nusinersen, qty 12 mg) - injection, solution - excipient ingredients: calcium chloride dihydrate; sodium hydroxide; water for injections; potassium chloride; sodium chloride; monobasic sodium phosphate dihydrate; hydrochloric acid; dibasic sodium phosphate; magnesium chloride hexahydrate - spinraza is indicated for the treatment of 5q spinal muscular atrophy (sma).

Канада - Енглески - Health Canada

biogen canada inc - nusinersen (nusinersen sodium) - solution - 2.4mg - nusinersen (nusinersen sodium) 2.4mg - antisense oligonucleotides

Европска Унија - Енглески - EMA (European Medicines Agency)

biogen netherlands b.v. - nusinersen sodium - muscular atrophy, spinal - other nervous system drugs - spinraza is indicated for the treatment of 5q spinal muscular atrophy.

Сингапур - Енглески - HSA (Health Sciences Authority)

zuellig pharma pte. ltd. - nusinersen sodium eqv nusinersen - injection, solution - nusinersen sodium eqv nusinersen 12mg/5ml

Велика Британија - Енглески - MHRA (Medicines & Healthcare Products Regulatory Agency)

biogen idec ltd - nusinersen sodium - solution for injection - 2.4mg/1ml

Израел - Енглески - Ministry of Health

medison pharma ltd - nusinersen - solution for injection - nusinersen 2.4 mg / 1 ml - spinraza is indicated for the treatment of 5q spinal muscular atrophy except type 0 and type iv.

Израел - Енглески - Ministry of Health

medison pharma ltd - nusinersen - solution for injection - nusinersen 2.4 mg / 1 ml - spinraza is indicated for the treatment of 5q spinal muscular atrophy except type 0 and type iv.

Израел - Енглески - Ministry of Health

medison pharma ltd - nusinersen - solution for injection - nusinersen 2.4 mg / 1 ml - spinraza is indicated for the treatment of 5q spinal muscular atrophy except type 0 and type iv.

Израел - Енглески - Ministry of Health

medison pharma ltd - nusinersen - solution for injection - nusinersen 2.4 mg / 1 ml - spinraza is indicated for the treatment of 5q spinal muscular atrophy except type 0 and type iv.