METHYCOBAL Solution for injection Ref.[11047] Active ingredients: Mecobalamin

Source: Υπουργείο Υγείας (CY) Revision Year: 2007 Publisher: Marketing License Holder: Medilink Pharmaceuticals Ltd., 30 Armenias, 2003 Strovolos, Nicosia, Cyprus Manufacturer: Eisai Co. Ltd., 4-6-10 Koishikawa, Bunkyo-ku, Tokyo, Japan

Product name and form

Methycobal 500μg Inj.

Pharmaceutical Form
Ampoules for injection. Clinical particulars Methycobal is a mecobalamin preparation, coenzyme-type vitamin B₁₂ occurring in the blood and cerebrospinal fluid, which was developed by Eisai Co., Ltd. This active ingredient is transported to nerve tissues better than other types of vitamin B₁₂. Biochemically, mecobalamin promotes nucleic acid, protein and lipid metabolism through transmethylation reactions. Pharmacologically, mecobalamin repairs injured nerve tissues and inhibits abnormal impulse conduction. Mecobalamin promotes the maturation and division of erythroblast and heme synthesis thereby improving the blood picture in anemia. Clinically, Methycobal has been shown to benefit megaloblastic anemia and peripheral neuropathies such as diabetic neuropathy and polyneuritis. METHYCOBAL is the first vitamin B₁₂ preparation clinically proven to be effective by double-blind clinical trials.

Qualitative and quantitative composition

Methycobal Injection 500μg is clear, red liquid.

Each (l.0ml) ampoule contains 500μg of mecobalamin, and also contains 50mg of D-mannitol as an additive.

Active Ingredient	Description
Mecobalamin	Methylcobalamin is a cobalamin, a form of vitamin B12. Mecobalamin is a kind of endogenous coenzyme B₁₂. Mecobalamin plays an important role in transmethylation as a coenzyme of methionine synthetase in the synthesis of methionine from homocysteine. Mecobalamin promotes axonal transport and axonal regeneration. Mecobalamin promotes myelination (phospholipid synthesis). Methylcobalamin is used in the treatment of peripheral neuropathy, diabetic neuropathy, and as a preliminary treatment for amyotrophic lateral sclerosis.

List of Excipients
Water for injection D-Mannitol

Pack sizes and marketing

Methycobal Injection 500μg (l mL)

Boxes of 10 ampoules.

Product description

METHYCOBAL injection is a clear, red liquid contained in brown ampoules (one-point-cut type).

pH: 5.3 to 7.3

Osmotic pressure ratio: About 1 (ration relative to isotonic sodium chloride solution).

Physicochemical properties of the active ingredient

Chemical name: Cp α-[α-(5,6-Dimethylbenz-IΗ-imidazolyl)]-Coß-methylcobamide

Molecular formula: C₆₃H₉₁CoN₁₃Ο₁₄P

Molecular weight: 1,344.38

Mecobalamin occurs as dark red crystals or crystalline powder. It is odorless and tasteless. It is slightly soluble in water, methanol and ethanol, and practically insoluble in acetone, ether and chloroform. It is hygroscopic and is affected by light.

Marketing authorization holder

Marketing License Holder: Medilink Pharmaceuticals Ltd., 30 Armenias, 2003 Strovolos, Nicosia, Cyprus

Manufacturer: Eisai Co. Ltd., 4-6-10 Koishikawa, Bunkyo-ku, Tokyo, Japan

Marketing authorization dates and numbers

20203

24 November 1998

Drugs

Drug	Countries
METHYCOBAL	Cyprus, Hong Kong, Japan, Singapore

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