ADVERSE REACTIONS SECTION.
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.
INDICATIONS & USAGE SECTION.
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 & ADMINISTRATION SECTION.
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).
HOW SUPPLIED SECTION.
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.
SPL UNCLASSIFIED SECTION.
Manufactured for: Bioniche Pharma USA LLC, Lake Forest, IL 60045 Manufactured by: Bioniche Teo., Inverin, Co. Galway, Ireland Date Prepared: July 2001 Revised: May 2007 0415L103
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.
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.
STORAGE AND HANDLING SECTION.
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.
CONTRAINDICATIONS: Sensitivity to the ingredients listed.
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.