NEUROBION Solution for injection Ref.[4436] Active ingredients: Pyridoxine Vitamin B1 Vitamin B12

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: P&G Health Germany GmbH, Sulzbacher Strasse 40, 65824 Schwalbach am Taunus, Germany

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.

Active Ingredient Description
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 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.

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

P&G Health Germany GmbH, Sulzbacher Strasse 40, 65824 Schwalbach am Taunus, Germany

Marketing authorization dates and numbers

795

05/04/1971

Drugs

Drug Countries
NEUROBION Austria, Cyprus, Ecuador, Finland, Hong Kong, Poland, Singapore

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