SUCCINYLCHOLINE CHLORIDE injection, solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

SUCCINYLCHOLINE CHLORIDE (UNII: I9L0DDD30I) (SUCCINYLCHOLINE - UNII:J2R869A8YF)

Dostępny od:

Zydus Lifesciences Limited

Droga podania:

INTRAMUSCULAR

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Succinylcholine chloride is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Succinylcholine is contraindicated in persons with personal or familial history of malignant hyperthermia, skeletal muscle myopathies and known hypersensitivity to the drug. It is also contraindicated in patients after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, because succinylcholine administered to such individuals may result in severe hyperkalemia which may result in cardiac arrest (see WARNINGS ). The risk of hyperkalemia in these patients increases over time and usually peaks at 7 to 10 days after the injury. The risk is dependent on the extent and location of the injury. The precise time of onset and the duration of the risk period are not known.

Podsumowanie produktu:

Succinylcholine Chloride Injection, USP is supplied as a clear, colorless solution in the following concentrations and packages: Multiple-dose vials of 10 mL, box of 25 vials (NDC 70771-1352-7).   Refrigeration of the undiluted agent will assure full potency until expiration date. All units carry a date of expiration.   Store in refrigerator 2° to 8°C (36° to 46°F). The multi-dose vials are stable for up to 14 days at room temperature without significant loss of potency.   Manufactured by: Cadila Healthcare Limited Ahmedabad, India   Revised: 08/18

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

SUCCINYLCHOLINE CHLORIDE- SUCCINYLCHOLINE CHLORIDE INJECTION, SOLUTION
ZYDUS LIFESCIENCES LIMITED
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SUCCINYLCHOLINE CHLORIDE INJECTION, USP
SPL UNCLASSIFIED
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Vial Label
NDC 70771-1352-1
Succinylcholine Chloride Injection, USP
200 mg/10 mL (20 mg/mL)
For Intravenous or Intramuscular use.
10 mL Multiple-dose Vial
Rx only
Zydus Pharmaceuticals
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Carton Label
NDC 70771-1352-7
Succinylcholine Chloride Injection, USP
200 mg/10 mL (20 mg/mL)
For Intravenous or Intramuscular use.
Store in refrigerator 2º to 8ºC (36º to 46ºF).
25 (25 x 1) 10 mL Multiple-dose Vial
Rx only
Zydus Pharmaceuticals
SUCCINYLCHOLINE CHLORIDE
succinylcholine chloride injection, solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1352
ROUTE OF ADMINISTRATION
INTRAMUSCULAR, INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
SUCCINYLCHOLINE CHLORIDE (UNII: I9L0DDD30I) (SUCCINYLCHOLINE -
UNII:J2R869A8YF)
SUCCINYLCHOLINE
CHLORIDE
20 mg
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
HYDROCHLORIC ACID (UNII: QTT17582CB)
METHYLPARABEN (UNII: A2I8C7HI9T)
1.8 mg in 1 mL
Zydus Lifesciences Limited
PROPYLPARABEN (UNII: Z8IX2SC1OH)
0.2 mg in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1352-7
25 in 1 TRAY
05/10/2018
1
NDC:70771-
1352-1
10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a
Combination Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA209467
05/10/2018
LABELER -
Zydus Lifesciences Limited (918596198)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
918596198
ANALYSIS(70771-1352) , MANUFACTURE(70771-1352)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
873671928
MANUFACTURE(70771-1352) , ANALYSIS(70771-1352)
Revis