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
It is contraindicated in persons who may have had an allergic reaction such as skin rash, to any form of vitamin B12.
Methycobal should not be used aimlessly for more than one month unless it is effective.
Methycobal is susceptible to photolysis. It should be used promptly after the package is opened, and caution should be taken so as not to expose the ampoules to direct light.
In intramuscular administration, caution should be exercised by following the instruction mentioned below to avoid adverse effects on tissues or nerves.
a) Avoid repeated injection at the same site. Particular caution should be exercised when administering Methycobal to premature infants, neonates, nursing infants and children.
b) Do not inject in densely innervated site.
c) If insertion of the injection needle causes intense pain or if blood flows back into the syringe, withdraw the needle immediately and inject at a different site.
Methycobal is supplied in one-point-cut ampoules. The cut point of the ampoules should be wiped with an alcohol swab before opening.
No interaction has been reported by parenteral administration of Methycobal. Only for oral administration, proton pump inhibitors, H2 receptor antagonists and Mesalazine (5-aminosalicylic acid) may inhibit vitamin B 12 absorption from the digestive tract.
Labelled mecobalamin 57Co-CH3-B12 10μg/kg was administered intravenously to pregnant rats. Peak radioactivity concentrations in placenta and fetus were reached 30 minutes and 24 hours after the injection, respectively.
Labeled mecobalamin 57Co-CH3-B12 10μg/kg was administered intravenously to rats. Radioactivity concentration in breast milk reached its peak (42.9ng eq/mL) 6 hours after the administration, and gradually decreased thereafter.
No psychoneurological disorders have been reported such as sleepiness, confusion and movement disorders.
Anaphylactoid reaction such as decrease in blood pressure or dyspnea, may occur. Patients should be carefully observed. In the event of such symptoms, treatment should be discontinued immediately and appropriate measures taken.
Use of the drug should be discontinued if symptoms of hypersensitivity, such as rash, occur.
Diaphoresis and pain/induration may occur infrequently at the site of intramuscular injection. Headache and hot sensation may occur rarely.
When blended with acidic drugs, the color may change from red to reddish orange. The content, however, may not change. When blended with ascorbic acid under diffuse light, the content may decline as the color may change from red to reddish orange.
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