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

novartis gene therapies, inc. - adeno-associated virus (unii: b769i4xpy3) (adeno-associated virus - unii:b769i4xpy3) - zolgensma is an adeno-associated virus (aav) vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (sma) with bi-allelic mutations in the survival motor neuron 1 (smn1) gene. limitations of use - the safety and effectiveness of repeat administration of zolgensma have not been evaluated [see adverse reactions (6.2)] . - the use of zolgensma in patients with advanced sma (e.g., complete paralysis of limbs, permanent ventilator-dependence) has not been evaluated [see clinical studies (14)] . none. risk summary there are no available data regarding zolgensma use in pregnant women. no animal reproductive and developmental toxicity studies have been conducted with zolgensma. in the united states 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. risk summary there is no information available on the presence of zolgensma in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for zolgensma and any potential adverse effects on the breastfed child from zolgensma or from the underlying maternal condition. administration of zolgensma to premature neonates before reaching full-term gestational age is not recommended, because concomitant treatment with corticosteroids may adversely affect neurological development. delay zolgensma infusion until the corresponding full-term gestational age is reached. there is no information on whether breastfeeding should be restricted in mothers who may be seropositive for anti-aav9 antibodies. the safety of zolgensma was studied in pediatric patients who received zolgensma infusion at age 0.3 to 7.9 months (weight range, 3.0 kg to 8.4 kg) [see adverse reactions (6)] . the efficacy of zolgensma was studied in pediatric patients who received zolgensma infusion at age 0.5 to 7.9 months (weight range, 3.6 kg to 8.4 kg) [see clinical studies (14)] . zolgensma therapy should be carefully considered in patients with liver impairment. cases of acute serious liver injury and acute liver failure have been reported with zolgensma in patients with preexisting liver abnormalities. in clinical trials, elevation of aminotransferases was observed in patients following zolgensma infusion [see warnings and precautions (5.1)] .

Israel - English - Ministry of Health

sanofi - aventis israel ltd - adenosine - solution for injection - adenosine 6 mg / 2 ml - adenosine - adenosine - rapid conversion to a normal sinus rhythm of paroxysmal supraventicular tachycardias including those associated with accessory bypass tracts (wolf parkinson-white syndrome).

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

akorn - adenosine (unii: k72t3fs567) (adenosine - unii:k72t3fs567) - adenosine 3 mg in 1 ml - 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 artificial pacemaker). - known hypersensitivity to adenosine.

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

cardinal health - adenosine (unii: k72t3fs567) (adenosine - unii:k72t3fs567) - adenosine 3 mg in 1 ml - 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:

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

general injectables & vaccines, inc - adenosine (unii: k72t3fs567) (adenosine - unii:k72t3fs567) - adenosine 3 mg in 1 ml - 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

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

heritage pharmaceuticals inc. - adenosine (unii: k72t3fs567) (adenosine - unii:k72t3fs567) - adenosine 3 mg in 1 ml - adenosine injection, usp is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. adenosine injection is contraindicated in patients with: - second- or third-degree av block (except in patients with a functioning artificial pacemaker) [seewarnings and precautions (5.2) ] - sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker) [see warnings and precautions (5.2)] - known or suspected bronchoconstrictive or bronchospastic lung disease (e.g., asthma) [see warnings and precautions (5.3)] - known hypersensitivity to adenosine [seewarnings and precautions (5.7)] pregnancy category c. animal reproduction studies have not been conducted with adenosine; nor have studies been performed in pregnant women. because it is not known whether adenosine injection can cause fetal harm when administered to pregnant women, adenosine injection should be used during pregnancy only if clea

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

heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc. - adenosine (unii: k72t3fs567) (adenosine - unii:k72t3fs567) - adenosine 3 mg in 1 ml - adenosine injection, usp is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. adenosine injection is contraindicated in patients with: - second- or third-degree av block (except in patients with a functioning artificial pacemaker) [see warnings and precautions (5.2)] - sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker) [see warnings and precautions (5.2)] - known or suspected bronchoconstrictive or bronchospastic lung disease (e.g., asthma) [see warnings and precautions (5.3)] - known hypersensitivity to adenosine [see warnings and precautions (5.7)] pregnancy category c. animal reproduction studies have not been conducted with adenosine; nor have studies been performed in pregnant women. because it is not known whether adenosine injection can cause fetal harm when administered to pregnant women, adenosine injection should be used during pregnancy only if cle

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

mylan institutional llc - adenosine (unii: k72t3fs567) (adenosine - unii:k72t3fs567) - adenosine 3 mg in 1 ml - adenosine injection is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. adenosine is contraindicated in patients with: pregnancy category c . animal reproduction studies have not been conducted with adenosine; nor have studies been performed in pregnant women. because it is not known whether adenosine can cause fetal harm when administered to pregnant women, adenosine should be used during pregnancy only if clearly needed. it is not known whether adenosine is excreted in human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions from adenosine in nursing infants, the decision to interrupt nursing after administration of adenosine or not to administer adenosine, should take into account the importance of the drug to the mother. the safety and effectiveness of adenosine in patients less than 18 years of age have not been established. clinical studies with adenosine did not include suffic

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

physicians total care, inc. - adenosine (unii: k72t3fs567) (adenosine - unii:k72t3fs567) - adenosine 3 mg in 1 ml - 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 arti

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

gland pharma limited - adenosine (unii: k72t3fs567) (adenosine - unii:k72t3fs567) - adenosine 3 mg in 1 ml - adenosine injection, usp 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: 1. second- or third-degree a-v block (except in patients with a functioning artificial pacemaker). 2. sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patien