Product Name and Form
Solution for injection Red, clear solution.
Qualitative and Quantitative Composition
3 ml of aqueous solution (1 ampoule) contains:
Thiamine chloride hydrochloride (vitamin B1): 100 mg
Pyridoxine hydrochloride (vitamin B6): 100 mg
Cyanocobalamin (vitamin B12): 1 mg
Excipients: Contains 42 mg sodium per ampoule and traces of potassium.
For a full list of excipients see section 6.1.
Thiamine pyrophosphate (TPP), the coenzymatic form of thiamine, is involved in two main types of metabolic reactions: decarboxylation of α-ketoacids (e.g. pyruvate, α-ketoglutarate and branched-chain keto acids) and transketolation (e.g. among hexose and pentose phosphates). Therefore, the principal physiological role of thiamine is as a coenzyme in carbohydrate metabolism, where TPP is required for several stages in the breakdown of glucose to provide energy.
Pyridoxine hydrochloride is Vitamin B6. It is converted to pyridoxal phosphate which is the co-enzyme for a variety of metabolic transformations. It is essential for human nutrition.
Hydroxocobalamin is used in the treatment and prevention of Vitamin B12 deficiency. For adults, the daily requirement of Vitamin B12 is probably about 1 to 2 micrograms and this amount is present in most normal diets. However, Vitamin B12 only occurs in animal products, not in vegetables, and therefore strict vegetarian or vegan diets that exclude dairy products may provide an inadequate amount, although a deficiency may not be apparent for many years.
Sodium hydroxide (for pH adjustment)
Water for injection
Pack sizes and Marketing
Amber glass ampoules (Type I) with 3 ml injection solution.
Package sizes: 3 Ampules.
Not all pack sizes may be marketed.
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