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)

zydus lifesciences 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

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 injection is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen. overdose incidences are divided into two types; acute ingestion or repeated supratherapeutic ingestion (rsi). [see dosage and administration ( 2 ) and acetaminophen assays – interpretation and methodology -(acute or repeated supratherapeutic ingestion) ( 1.1 , 1.2 )] . on admission for suspected acetaminophen overdose, a serum blood sample should be drawn at least 4 hours after ingestion to determine the acetaminophen level and will serve as a basis for determining the need for treatment with acetylcysteine. if the patient presents after 4 hours post-ingestion, the serum acetaminophen sample should be determined immediately. acetylcysteine injection should be administered within 8 hours from acetaminophen ingestion for maximal protection against hepatic injury for patie

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

apotex sa-nv - acetylcysteine 600 mg - effervescent tablet - 600 mg - acetylcysteine 600 mg - acetylcysteine

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

apotex sa-nv - acetylcysteine 600 mg - granules for oral solution - 600 mg - acetylcysteine 600 mg - acetylcysteine

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eg sa-nv - acetylcysteine 200 mg - capsule, hard - 200 mg - acetylcysteine 200 mg - acetylcysteine

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eg sa-nv - acetylcysteine 600 mg - oral powder - 600 mg - acetylcysteine 600 mg - acetylcysteine

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eg sa-nv - acetylcysteine 600 mg - effervescent tablet - 600 mg - acetylcysteine 600 mg - acetylcysteine

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eg sa-nv - acetylcysteine 200 mg - oral powder - 200 mg - acetylcysteine 200 mg - acetylcysteine