País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
Cysteine Hydrochloride (UNII: ZT934N0X4W) (Cysteine - UNII:K848JZ4886)
Sandoz Inc
Cysteine Hydrochloride
Cysteine 50 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
L-Cysteine Hydrochloride Injection, USP is intended for use only after dilution as an additive to Crystalline Amino Acid Injections to meet the intravenous amino acid nutritional requirements of infants receiving total parenteral nutrition. This preparation should not be used in patients with hepatic coma or metabolic disorders involving impaired nitrogen utilization. None known.
L-Cysteine Hydrochloride Injection, USP (50 mg/mL) is supplied as follows: NDC Number Volume 0781-8940-70 10 mL 0781-8940-95 10 x 10 mL Store at controlled room temperature 15°-30°C (59°-86°F) Do not freeze. For Sandoz Inc. Customer Service, call 1-800-525-8747. Rx only Manufactured in Canada by Avara Boucherville Pharmaceutical Services, Inc. for Sandoz Inc., Princeton, NJ 08540 Product of Japan Revised: August 2018 46236914
unapproved drug other
L-CYSTEINE HYDROCHLORIDE- L-CYSTEINE HYDROCHLORIDE INJECTION, SOLUTION SANDOZ INC _Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been_ _approved by FDA. For further information about unapproved drugs, click here._ ---------- L-CYS TEINE HYDROCHLORIDE INJECTION, USP 0.5 G/10 ML (50 MG/ML) DESCRIPTION L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, is a sterile, nonpyrogenic solution. Each mL contains: 50 mg of L-Cysteine Hydrochloride Monohydrate USP; Water for Injection, USP q.s.; Air replaced with Nitrogen. pH 1.0-2.5 L-Cysteine is a sulfur-containing amino acid. In premixed solutions of crystalline amino acids, cysteine is relatively unstable over time, eventually converting to insoluble cystine. To avoid such precipitation, L-Cysteine Hydrochloride Injection USP is intended to be used as an additive with Crystalline Amino Acid Injections immediately prior to administration to the patient. The structural formula of Cysteine Hydrochloride Monohydrate USP is: MOLECULAR WEIGHT MOLECULAR FORMULA 175.63 C H NO S•HCl•H O CLINICAL PHARMACOLOGY L-Cysteine is synthesized from methionine via the trans-sulfuration pathway in the adult, but newborn infants lack the enzyme necessary to effect this conversion. Therefore, L-Cysteine is generally considered to be an essential amino acid in infants. INDICATIONS AND USAGE L-Cysteine Hydrochloride Injection, USP is intended for use only after dilution as an additive to Crystalline Amino Acid Injections to meet the intravenous amino acid nutritional requirements of infants receiving total parenteral nutrition. CONTRAINDICATIONS This preparation should not be used in patients with hepatic coma or metabolic disorders involving impaired nitrogen utilization. WARNINGS Peripheral intravenous infusion of amino acids may induce a rise in blood urea nitrogen (BUN) especially in patients with impaired hepatic or renal function. Appropriate laboratory tests should be 3 7 2 2 performed periodically and infusion discontinued if BUN Leia o documento completo