Megabal

Megabal

mecobalamin

Manufacturer:

Sanbe

Marketer:

Sanbe
Full Prescribing Info
Contents
Mecobalamin.
Description
Inj: Each mL contains: Mecobalamin 500 μg.
Action
Pharmacology: Mecobalamin which biochemically is a Vitamin B12 containing co-enzyme with an active methyl base. Mecobalamin participates in transmethylation reactions and is the most active of all B12 homologs in the body with respect to nucleic acid, protein and lipid metabolism. Mecobalamin acts to repair damaged nerve tissue in nerve disorders, such as axonal degeneration and demyelination; and it is involved in erythroblast maturation, promotion of erythroblast division and heme synthesis, thus acting to improve the status of the blood in megaloblastic anemia.
Indications/Uses
Peripheral neuropathies.
Cap: Megaloblastic anemia due to vit B12 deficiency.
Dosage/Direction for Use
Cap: 1 capsule three times daily.
Inj: The usual adult dose is 1 ampoule, equivalent to 500 μg 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.
Contraindications
Inj: Hypersensitivity to Mecobalamin.
Special Precautions
Inj: Mecobalamin is susceptible to photolysis (can decompose due to light even when in a brown ampoule), then must be used immediately after the package is opened and do not exposed the ampoules to light because exposure to light result in a decrease in the content of the active ingredient.
In intramuscular administration, care should be exercised, as suggested as follows, to avoid adverse effects on tissues or nerves: Repeated injection at the same site should be avoided. Particular care should be exercised when administering this drugs to neonates, premature infants, infants and children.
The course of nerves should be avoided for the site of injection.
If the patient complains of pain or if blood reflux occurs when the syringe needle is stuck, withdraw it immediately and try at a different site.
This drug should not be used over a period of months if there is lack of satisfactory clinical response in patients with megaloblastic anemia or with peripheral neuropathies probably due to vitamin B12 deficiency.
Adverse Reactions
Nausea, diarrhea, skin rash.
Cap: Anorexia.
Inj: Hypersensitivity.
Reduced appetite, or other gastrointestinal disorders may arise.
Anaphylaxis, dyspnea, headache and hot sensation.
Other: Infrequently, pain and induration at the site of injection and headache, sweating or fever may rarely occur.
Drug Interactions
It is not known whether Mecobalamin can cause clinically significant interactions with other drug.
Caution For Usage
Inj: Special precaution for use: MEGABAL injection is very sensitive to light exposure so it is packed in aluminium sachets. MEGABAL injection must be used immediately after being removed from the aluminium sachet and avoided from exposure to light.
Close the aluminium sachet immediately after the ampoule is removed from blister pack
Use MEGABAL injection before the expired date state on the packaging.
Storage
Inj: Store below 30°C, away from light.
Patient Counseling Information
Inj: How to take ampoule: 1. Tear off the aluminium sachets in the v-cut section.
2. Open the zip-lock carefully, then pull the blister gently to show only 1 ampoule to prevent light exposure on other ampoules.
3. Take out the ampoule from the blister.
4. Immediately close the zip-lock tightly.
ATC Classification
B03BA05 - mecobalamin ; Belongs to the class of vitamin B12 (cyanocobalamin and analogues). Used in the treatment of anemia.
Presentation/Packing
Cap 500 mcg x 10 x 10's. Inj 500 mcg/mL x 1 mL x 2 x 5's.
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