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NEUROBION Sol. (2012)

Active ingredients: Vitamin B1 Pyridoxine Vitamin B12

Product Name and Form

Neurobion ampoules.

Pharmaceutical 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.

Chemical substance
Description
Vitamin B1

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

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.

Vitamin B12

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.

List of excipients

Sodium hydroxide (for pH adjustment)
Potassium cyanide
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.

Marketing authorization holder
Authorization dates

Merck A.E.
41-45 Kifisias ave. (Building B')
15123
Marousi
Athens
Greece

05/04/1971

Marketing authorization number:

795