Label: B-PLEX 100- thiamine hydrochloride, riboflavin 5'-phosphate sodium, pyridoxine hydrochloride, dexpanthenol and niacinamide injection, solution
- NDC Code(s): 30727-300-80
- Packager: Merit Pharmaceutical
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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DESCRIPTION: Vitamin B-Complex 100 Injection is a sterile solution for intramuscular or slow intravenous injection comprised of vitamins which may be categorized as belonging to the vitamin B complex group.
Each mL contains: Thiamine Hydrochloride 100mg, Riboflavin 5' Phosphate Sodium 2mg, Pyridoxine Hydrochloride 2mg, Dexpanthenol 2mg, Niacinamide 100 mg, with Benzyl Alcohol 2% as preservative in Water for Injection. Sodium Hydroxide and/or Hydrochloric Acid may have been used to adjust pH.Close
- INDICATIONS & USAGE
INDICATIONS AND USAGE: In disorders requiring parenteral administration of vitamins, i.e. pre- and post-operative treatment, when requirements are increased as in fever, severe burns, increased metabolism, pregnancy, gastrointestinal disorders interfering with intake or absorption of vitamins, prolonged or wasting diseases, alcoholism and where other deficiencies exist.Close
CONTRAINDICATIONS: Sensitivity to the ingredients listed.Close
WARNINGS: Anaphylactogenesis may occur with parenteral thiamine. Use with caution. An intradermal test dose is recommended prior to administration in patients suspected of being sensitive to the drug.Close
PRECAUTIONS: The usual precautions for parenteral administration should be observed. Do not inject if precipitation occurs. Inject slowly by the intravenous route. High concentrations should be diluted using Normal Saline Injection when given intravenously.Close
- ADVERSE REACTIONS
ADVERSE REACTIONS: Mild transient diarrhea, polycythemia vera, peripheral vascular thrombosis, itching transitory exanthema, feeling of swelling of entire body, anaphylactic shock and death.
Sensitivity to the ingredients listed my occur (See WARNINGS). Use should be discontinued upon observance of any untoward reaction. Pain upon intramuscular injection may be noted.Close
- DOSAGE & ADMINISTRATION
DOSAGE AND ADMINISTRATION: Usually 0.25 to 2 mL by intramuscular or slow intravenous injection. High concentrations given intravenously may be diluted using parenteral infusion solutions. (See PRECAUTIONS).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permint (See How Supplied).Close
- HOW SUPPLIED
HOW SUPPLIED: Vitamin B-Complex 100 Injection is available in a 30mL multiple dose vial individually boxed.
Phase separation due to reduced solubility can occur under certain conditions of shipping or storage (e.g. accidental freezing), which may produce visible particles. Do not use product if these do not redissolve on warming to body temperature and shaking well.
Refrigeration of the product may cause darkening of the solution due to the riboflavin content. The colour does not affect the safety or efficacy of the product.Close
- SPL UNCLASSIFIED SECTION
- STORAGE AND HANDLING
PROTECT FROM LIGHT: Store in carton until contents are used. Store under refrigeration 2 deg - 8 deg C (36 deg - 46 deg F). Do not permit to freeze.Close
- SPL UNCLASSIFIED SECTION
Bioniche Pharma USA LLC,
Lake Forest, IL 60045
Inverin, Co. Galway, Ireland
Date Prepared: July 2001
Revised: May 2007
- INGREDIENTS AND APPEARANCE
thiamine hydrochloride, riboflavin 5-phosphate sodium, pyridoxine hydrochloride, dexpanthenol, niacinamide injection, solution
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:30727-300 Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Thiamine Hydrochloride (UNII: M572600E5P) (Thiamine Ion - UNII:4ABT0J945J) Thiamine Hydrochloride 100 mg in 1 mL RIBOFLAVIN 5'-PHOSPHATE SODIUM (UNII: 20RD1DZH99) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 2 mg in 1 mL Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 2 mg in 1 mL Dexpanthenol (UNII: 1O6C93RI7Z) (Dexpanthenol - UNII:1O6C93RI7Z) Dexpanthenol 2 mg in 1 mL Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength Sodium Hydroxide (UNII: 55X04QC32I) Benzyl Alcohol (UNII: LKG8494WBH) Water (UNII: 059QF0KO0R) Hydrochloric Acid (UNII: QTT17582CB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30727-300-80 1 in 1 CARTON 1 30 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2012 Labeler - Merit Pharmaceutical (093370369) Registrant - Merit Pharmaceutical (093370369)