L-CYSTEINE HYDROCHLORIDE injection, solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

Cysteine Hydrochloride (UNII: ZT934N0X4W) (Cysteine - UNII:K848JZ4886)

זמין מ:

Sandoz Inc

INN (שם בינלאומי):

Cysteine Hydrochloride

הרכב:

Cysteine 50 mg in 1 mL

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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.

leaflet_short:

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

מצב אישור:

unapproved drug other

מאפייני מוצר

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._
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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