ntramuscularly to infants, older children, or adults when a suitable vein is inaccessible. A dose of up to 3 to 4 mg/kg may be given, but not more than 150 mg total dose should be administered by this route. The onset of effect of succinylcholine given intramuscularly is usually observed in about 2 to 3 minutes.
Compatibility and Admixtures
Succinylcholine is acidic (pH 3.5) and should not be mixed with alkaline solutions having a pH greater than 8.5 (e.g., barbiturate solutions). ANECTINE Injection is stable for 24 hours after dilution to a final concentration of 1 to 2 mg/mL in 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP. Aseptic techniques should be used to prepare the diluted product. Admixtures of ANECTINE should be prepared for single patient use only. The unused portion of diluted ANECTINE should be discarded.
HOW SUPPLIED
For immediate injection of single doses for short procedures: ANECTINE (succinylcholine chloride) Injection, 20 mg in each mL.
Multiple-dose vials of 10 mL, box of 10 vials (NDC 0781-3009-95).
Store in refrigerator at 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.
SPL UNCLASSIFIED SECTION
Manufactured by
Agila Specialties Pvt. Ltd.
(Specialty Formulation Facility)
Bangalore – 560 105, India for
Sandoz Inc.
Princeton, NJ 08540
04-2011
1016206
Manufactured by
Agila Specialties Pvt. Ltd.
(Sterile Product Division)
Bangalore – 560 076, India for
Sandoz Inc.
Princeton, NJ 08540
04-2011
1016227
200 MG LABEL
Anectine 200 mg Label
NDC 0781-3009-70
Anectine®
(succinylcholine
chloride injection, USP)
200 mg/10 mL
(20 mg/mL)
WARNING: Paralyzing Agent.
Causes Respiratory Arrest.
Multiple-Dose Vial
SANDOZ
INGREDIENTS AND APPEARANCE
ANECTINE
succinylcholine chloride injection, solution
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-3009
Route of Administration INTRAVENOUS, INTRAMUSCULAR, PARENTERAL
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
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROCHLORIC ACID (UNII: QTT17582CB)
METHYLPARABEN (UNII: A2I8C7HI9T) 1 mg in 1 mL
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0781-3009-95 10 in 1 CARTON
1 NDC:0781-3009-70 10 mL in 1 VIAL, MULTI-DOSE
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA008453 08/20/1952
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