METHYCOBAL Solution for injection (2007)
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Περιεχόμενα
1. Name of the medicinal product
Methycobal 500μg Inj.
2. 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.
3. Pharmaceutical form
Ampoules for injection. Clinical particulars Methycobal is a mecobalamin preparation, coenzyme-type vitamin B<sub>12</sub> occurring in the blood and cerebrospinal fluid, which was developed by Eisai Co., ...
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 ...
4.3. Contraindications
It is contraindicated in persons who may have had an allergic reaction such as skin rash, to any form of vitamin B<sub>12</sub>.
4.4. Special warnings and precautions for use
General Methycobal should not be used aimlessly for more than one month unless it is effective. Precautions concerning use Administration Methycobal is susceptible to photolysis. It should be used promptly ...
4.5. Interaction with other medicinal products and other forms of interaction
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 ...
4.6. Pregnancy and lactation
Labelled mecobalamin <sup>57</sup>Co-CH<sub>3</sub>-B<sub>12</sub> 10μg/kg was administered intravenously to pregnant rats. Peak radioactivity concentrations in placenta and fetus were reached 30 minutes ...
4.7. Effects on ability to drive and use machines
No psychoneurological disorders have been reported such as sleepiness, confusion and movement disorders.
4.8. Undesirable effects
Anaphylactoid reaction 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 ...
4.9. Overdose
There have been no reports of serious ill-effects from overdose.
5.1. Pharmacodynamic properties
Pharmacological Properties Introduction The active ingredient of Methycobal is mecobalamin (INN, JAN), that is an analogue of vitamin B<sub>12</sub> developed by Eisai Co., Ltd. Vitamin B<sub>12</sub> ...
5.2. Pharmacokinetic properties
Single-dose administration When a single i.m. or i.v. Of 500μg of mecobalamin was administered to healthy adult volunteers, the time required for the serum total vitamin B<sub>12</sub> level to reach (t ...
5.3. Preclinical safety data
Clinical efficacy In a double-blind comparison clinical trial with a low-dose group (100μg), the efficacy of mecobalamin in peripheral neuropathies in the chronic fixed stage was demonstrated. In a placebo-controlled ...
6.1. List of excipients
Water for injection D-Mannitol
6.2. Incompatibilities
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 ...
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). ...
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 ...
7. 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
8. Marketing authorization number(s)
20203
9. Date of first authorization / renewal of the authorization
24 November 1998
10. Date of revision of the text
February 2007
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