vitamin B complex Injectable Solution

Generic Name: THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, PYRIDOXINE HYDROCHLORIDE, DEXPANTHENOL, NIACINAMIDE
Brand Name: B-PLEX 100
  • Substance Name(s):
  • RIBOFLAVIN 5′-PHOSPHATE SODIUM
  • PYRIDOXINE HYDROCHLORIDE
  • THIAMINE HYDROCHLORIDE
  • DEXPANTHENOL
  • NIACINAMIDE

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.

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.

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.

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.

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).