ACETYLCYSTEINE injection, solution

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

ACETYLCYSTEINE (UNII: WYQ7N0BPYC) (ACETYLCYSTEINE - UNII:WYQ7N0BPYC)

Fáanlegur frá:

Zydus Lifesciences Limited

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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

Vörulýsing:

Acetylcysteine injection is available as a 20% solution (200 mg/mL) in 30 mL single-dose glass vials. Each single dose vial contains 6 g/30 mL (200 mg/mL) of acetylcysteine injection. Acetylcysteine injection is sterile and can be used for intravenous administration. It is available as follows: Do not use previously opened vials for intravenous administration. Note: The color of Acetylcysteine injection may turn from essentially colorless to a slight pink or purple once the stopper is punctured. The color change does not affect the quality of the product. The stopper in the Acetylcysteine injection vial is formulated with a synthetic base-polymer and does not contain Natural Rubber Latex, Dry Natural Rubber, or blends of Natural Rubber. Store unopened vials at controlled room temperature, 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

ACETYLCYSTEINE - ACETYLCYSTEINE INJECTION, SOLUTION
ZYDUS LIFESCIENCES LIMITED
----------
ACETYLCYSTEINE INJECTION
PRINCIPAL DISPLAY PANEL – VIAL LABEL
NDC 70771-1412-1
ACETYLCYSTEINE INJECTION
6 G/30 ML
(200 mg/mL)
MUST BE FURTHER DILUTED
PRIOR TO INTRAVENOUS USE
30 mL Sterile
Rx only
PRINCIPAL DISPLAY PANEL – CARTON LABEL
NDC 70771-1412-8
ACETYLCYSTEINE INJECTION
6 G/30 ML
(200 mg/mL)
MUST BE FURTHER DILUTED
PRIOR TO INTRAVENOUS USE
4 X 30 mL Sterile Vials
Rx only
ACETYLCYSTEINE
acetylcysteine injection, solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1412
ROUTE OF ADMINISTRATION
INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
ACETYLCYSTEINE (UNII: WYQ7N0BPYC) (ACETYLCYSTEINE -
UNII:WYQ7N0BPYC)
ACETYLCYSTEINE
200 mg
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
Zydus Lifesciences Limited
EDETATE DISODIUM (UNII: 7FLD91C86K)
NITROGEN (UNII: N762921K75)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1412-8
4 in 1 CARTON
01/17/2019
1
NDC:70771-
1412-1
30 mL in 1 VIAL; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA208166
01/17/2019
LABELER -
Zydus Lifesciences Limited (918596198)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
918596198
ANALYSIS(70771-1412) , MANUFACTURE(70771-1412)
Revised: 10/2022