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

zydus pharmaceuticals usa inc. - acetylcysteine (unii: wyq7n0bpyc) (acetylcysteine - unii:wyq7n0bpyc) - acetylcysteine injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (rsi). acetylcysteine injection is contraindicated in patients with a previous hypersensitivity reaction to acetylcysteine [see warnings and precautions ( 5.1)] . risk summary limited published case reports and case series of pregnant women exposed to acetylcysteine during various trimesters are not sufficient to inform any drug associated risk. delaying treatment of acetaminophen overdose may increase the risk of maternal or fetal morbidity and mortality [see clinical considerations]. reproduction studies in rats and rabbits following oral administration of acetylcysteine during the period of organogenesis at doses similar to the total intravenous dose (based on the body surface area) did not cause any adverse effects to the fetus. the estimated background risk of major birth defects and

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

fresenius kabi usa, llc - acetylcysteine (unii: wyq7n0bpyc) (acetylcysteine - unii:wyq7n0bpyc) - acetylcysteine solution, usp is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretions in such conditions as: chronic bronchopulmonary disease (chronic emphysema, emphysema with bronchitis, chronic asthmatic bronchitis, tuberculosis, bronchiectasis and primary amyloidosis of the lung) acute bronchopulmonary disease (pneumonia, bronchitis, tracheobronchitis) pulmonary complications of cystic fibrosis tracheostomy care pulmonary complications associated with surgery use during anesthesia post-traumatic chest conditions atelectasis due to mucous obstruction diagnostic bronchial studies (bronchograms, bronchospirometry, and bronchial wedge catheterization) acetylcysteine is contraindicated in those patients who are sensitive to it. acetylcysteine solution, usp administered orally, is indicated as an antidote to prevent or lessen hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen. it is essential to initiate trea

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

healol pharmaceuticals sdn. bhd. - acetylcysteine -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

healol pharmaceuticals sdn. bhd. - acetylcysteine -

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

sagent pharmaceuticals - acetylcysteine (unii: wyq7n0bpyc) (acetylcysteine - unii:wyq7n0bpyc) - acetylcysteine injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (rsi). acetylcysteine is contraindicated in patients with a previous hypersensitivity reaction to acetylcysteine [see warnings and precautions (5.1)] . risk summary limited published case reports and case series of pregnant women exposed to acetylcysteine during various trimesters are not sufficient to inform any drug associated risk. delaying treatment of acetaminophen overdose may increase the risk of maternal or fetal morbidity and mortality [see clinical considerations]. reproduction studies in rats and rabbits following oral administration of acetylcysteine during the period of organogenesis at doses similar to the total intravenous dose (based on the body surface area) did not cause any adverse effects to the fetus. the estimated background risk of major birth defects and miscarriage

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

indoco remedies limited - acetylcysteine (unii: wyq7n0bpyc) (acetylcysteine - unii:wyq7n0bpyc) - acetylcysteine injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (rsi). acetylcysteine injection is contraindicated in patients with a previous hypersensitivity reaction to acetylcysteine [see warnings and precautions (5.1)] . risk summary limited published case reports and case series of pregnant women exposed to acetylcysteine during various trimesters are not sufficient to inform any drug associated risk. delaying treatment of acetaminophen overdose may increase the risk of maternal or fetal morbidity and mortality [see clinical considerations]. reproduction studies in rats and rabbits following oral administration of acetylcysteine during the period of organogenesis at doses similar to the total intravenous dose (based on the body surface area) did not cause any adverse effects to the fetus. the estimated background risk of major birth defects and mi

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

baxter healthcare corporation - cysteine hydrochloride (unii: zt934n0x4w) (cysteine - unii:k848jz4886) - cysteine hydrochloride injection, usp is indicated for use as an additive to amino acids solutions to meet nutritional requirements of neonates (preterm and term infants less than one month of age) requiring total parenteral nutrition. cysteine hydrochloride injection, usp is contraindicated in: risk summary cysteine hydrochloride injection, usp for use as an additive to amino acid solutions to meet nutritional requirements is not indicated for use in adults. appropriate administration of cysteine hydrochloride injection, usp is not expected to cause major birth defects, miscarriage or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with cysteine hydrochloride. risk summary cysteine hydrochloride injection, usp is used as an additive to amino acid solutions to meet nutritional requirements of neonates requiring total parenteral nutrition and is not indicated for use in adults. there are no data on the presence of cysteine hydrochloride in human or animal milk or the effects on milk production. data available on the effects of cysteine hydrochloride on infants, either directly or through breastmilk, do not suggest a significant risk of adverse reactions from exposure. cysteine hydrochloride injection, usp is indicated for use as an additive to amino acid solutions to meet the nutritional requirements of neonates, including preterm infants, requiring total parenteral nutrition. the safety profile for cysteine hydrochloride injection, usp use in neonates includes risks of acid-base imbalance and hepatobiliary dysfunction. acid-base imbalance, including metabolic acidosis, and liver dysfunction may occur with cysteine hydrochloride injection, usp administration in preterm infants. frequent clinical and laboratory assessments are necessary to monitor and manage fluid balance, electrolyte concentrations, liver tests, and acid-base balance during parenteral nutrition therapy [see warnings and precautions (5.4)]. hyperammonemia is of special significance in neonates. this reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. it is essential that blood ammonia be measured during treatment [see warnings and precautions (5.5)]. because of immature renal function, neonates including preterm infants, receiving prolonged parenteral nutrition with cysteine hydrochloride injection, usp may be at higher risk of aluminum toxicity [see warnings and precautions (5.7)].

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

almaject, inc. - acetylcysteine (unii: wyq7n0bpyc) (acetylcysteine - unii:wyq7n0bpyc) - acetylcysteine injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (rsi). acetylcysteine injection is contraindicated in patients with a previous hypersensitivity reaction to acetylcysteine [see warnings and precautions (5.1)] . risk summary limited published case reports and case series of pregnant women exposed to acetylcysteine during various trimesters are not sufficient to inform any drug associated risk. delaying treatment of acetaminophen overdose may increase the risk of maternal or fetal morbidity and mortality [see clinical considerations] . reproduction studies in rats and rabbits following oral administration of acetylcysteine during the period of organogenesis at doses similar to the total intravenous dose (based on the body surface area) did not cause any adverse effects to the fetus. the estimated background risk of major birth defects and mi

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

stelis biopharma limited - acetylcysteine (unii: wyq7n0bpyc) (acetylcysteine - unii:wyq7n0bpyc) - acetylcysteine injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (rsi). acetylcysteine injection  is contraindicated in patients with a previous hypersensitivity reaction to acetylcysteine [see warnings and precautions ( 5.1 )] . risk summary limited published case reports and case series of pregnant women exposed to acetylcysteine during various trimesters are not sufficient to inform any drug associated risk. delaying treatment of acetaminophen overdose may increase the risk of maternal or fetal morbidity and mortality [see clinical considerations]. reproduction studies in rats and rabbits   following oral administration of acetylcysteine during the period of organogenesis at doses similar to the total intravenous dose (based on the body surface area) did not cause any adverse effects to the fetus. the estimated background r

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

xellia pharmaceuticals usa llc - acetylcysteine (unii: wyq7n0bpyc) (acetylcysteine - unii:wyq7n0bpyc) - acetylcysteine injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (rsi). acetylcysteine injection is contraindicated in patients with a previous hypersensitivity reaction to acetylcysteine [see warnings and precautions (5.1)]. risk summary limited published case reports and case series of pregnant women exposed to acetylcysteine during various trimesters are not sufficient to inform any drug associated risk. delaying treatment of acetaminophen overdose may increase the risk of maternal or fetal morbidity and mortality [see clinical considerations]. reproduction studies in rats and rabbits following oral administration of acetylcysteine during the period of organogenesis at doses similar to the total intravenous dose (based on the body surface area) did not cause any adverse effects to the fetus. the estimated background risk of major birth defects and misc