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

4.1. Therapeutic indications

Peripheral neuropathies.

Megaloblastic anemia due to vitamin B12 deficiency.

4.2. Posology and method of administration

Peripheral neuropathies

The usual dose for adults is I ampoule (500μg of mecobalamin), administered intramuscularly or intravenously three times a week. The dose should be adjusted according to the age of patient and severity of symptoms.

Megaloblastic anemia

The usual dose for adults is 1 ampoule (500μg of mecobalamin), administered intramuscularly or intravenously three times a week. After approximately 2 months of medication, the dose should be reduced to a single administration one ampoule at I to 3-month intervals for maintenance therapy.

4.9. Overdose

There have been no reports of serious ill-effects from overdose.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Methycobal should be stored in LPE pack (Light Protect Easy open pack) at room temperature <25°C. (If ampoules are not kept in the LPE pack, mecobalamin decomposes by light and decreases the content). Keep out of the reach of children.

6.5. Nature and contents of container

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.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.