Malta - English - Medicines Authority

cherubino limited delf building, sliema road, gzira, gzr 1637, malta - adenosine - solution for infusion - adenosine 3 mg - cardiac therapy

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - adenosine - solution for injection - adenosine 3 mg/ml - cardiac therapy

Australia - English - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - adenosine, quantity: 30 mg - solution - excipient ingredients: sodium chloride; water for injections - intravenous adenosine (30 mg/10 ml) is a coronary vasodilator for use in conjunction with radionuclide myocardial perfusion imaging, in patients unable to exercise adequately.

United States - English - NLM (National Library of Medicine)

a-s medication solutions - adenosine (unii: k72t3fs567) (adenosine - unii:k72t3fs567) - adenosine injection is indicated for the following. conversion to sinus rhythm of paroxysmal supraventricular tachycardia (psvt), including that associated with accessory bypass tracts (wolff-parkinson-white syndrome). when clinically advisable, appropriate vagal maneuvers (e.g., valsalva maneuver), should be attempted prior to adenosine administration. it is important to be sure the adenosine solution actually reaches the systemic circulation (see dosage and administration ). adenosine does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm. in the presence of atrial flutter or atrial fibrillation, a transient modest slowing of ventricular response may occur immediately following adenosine administration. adenosine injection is contraindicated in: - second- or third-degree a-v block (except in patients with a functioning artificial pacemaker). - sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning art

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - adenosine - solution for injection - adenosine 3 mg/ml - cardiac therapy

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - adenosine - solution for infusion - adenosine 30mg / 10ml - cardiac therapy

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - adenosine - solution for injection - adenosine 3 mg/ml - cardiac therapy

Kenya - English - Pharmacy and Poisons Board

pharma bavaria international gmbh 83209 prien am chiemsee - adenosine - solution for injection - 6mg/2ml - adenosine

Kenya - English - Pharmacy and Poisons Board

pharma bavaria internacional (pbi) rua do monte leite, 498-1dto, 2765-496-estoril, - adenosine solution for injection 6mg/2ml - solution for injection/infusion - 6mg/2ml - adenosine

United States - English - 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.