COBALIN Injection Ref.[7149] Active ingredients: Vitamin B12

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK

Product name and form

Cobalin-H.

Hydroxocobalamin 1000 microgram/ml Injection.

Pharmaceutical Form

Injection.

Qualitative and quantitative composition

Anhydrous hydroxocobalamin 1000microgram/ml.

For the full list of excipients, see section 6.1.

Active Ingredient Description
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 dihydrogen orthophosphate
Sodium chloride
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Water for injections

Pack sizes and marketing

This medicine is supplied in clear 1ml Type I glass ampoules in cartons of 5 or 10.

Marketing authorization holder

Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK

Marketing authorization dates and numbers

PL 20072/0217

18th June 1993 / 6th November 1998

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