Methylcobalamin Injection

Methylcobalamin Injection is a brand of medicine containing the active ingredients co-methylcobalamin.

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

Methylcobalamin 10mg in 2mL Injection


Consumer Medicine Information

FORMULATION:

2mL of this formulation contains:
Co-methylcobalamin 10mg
Sodium chloride 18mg
Water for injections to 2mL

Back to top

DESCRIPTION:

The solution is a crimson red colour and is totally clear. If the solution is cloudy or contains visually detectable particles, please contact the Quality Control Officer at Biological Therapies. Each vial contains a minimum of 2mL of solution.

Back to top

PRESENTATION:

4 pack sizes:
6 x 2mL vials
3 x 2mL vials
5 x 2mL vials
1 x 2mL vial

Back to top

STORAGE:

Store below -5°C (Freeze). Protect from light. Methycobalamin 10mg in 2mL Injection is sensitive to light even when in an amber vial. Seal box immediately after removal of each vial and store in freezer.

Expiry Date is 12 months from the date of manufacture.

Back to top

DOSAGE AND ADMINISTRATION:

The solution should be administered as soon as possible after removal from the box. 2mL by slow intramuscular (deep intragluteal) injection. Frequency as determined by the physician. This product is for SINGLE USE ONLY.

USE ONCE ONLY and discard any residue.

Back to top

WARNINGS:

  1. Should Anaphylactic Shock occur, immediately stop administration of the product and administer the appropriate dose of adrenalin 1:1000 (1mg/1mL) intramuscularly. This may be repeated at 5 minute intervals, if clinically indicated. Additionally, intravenous administration of corticosteroids and antihistamines may be considered.
  2. Hypersensitivity to the B vitamins may be checked by intradermal injection. Patients with a documented allergic disposition to the B vitamins should receive an intradermal test dose of Methylcobalamin 10mg in 2mL Injection prior to administration of the vitamin.

Back to top

INDICATIONS:

Cobalamin deficiency may exist that is unable to be corrected by oral intake and in these cases parenteral administration may be preferable. Oral administration of vitamin B12 may be insufficient in pernicious anaemia, malabsorption disorders, gastrectomy and gastrointestinal pathologies.

Specific indications may include:

  1. Pernicious anaemia as a result of in situ B12 deficiency. In pernicious anaemia co-methycobalamin is disproportionately reduced in relation to other cobalamins.
  2. As an adjunct to the treatment of peripheral neuropathies and diabetic polyneuropathy.

Back to top

GENERAL INFORMATION REGARDING CO-METHYLCOBALAMIN:

It is not known that most of the cobalains in humans occur as the two coenzyme forms, adenosylcobalamin and co-methylcobalamin. Co-methylcobalamin constitutes 60-80% of the total plasma cobalamin. In pernicious anaemia, co-methylcobalamin is disproportionately reduced in relation to other cobalamins.

Back to top

CONTRAINDICATIONS:

History of allergy to cobalamins (vitamin B12 and related compounds). Cobalamins should not, if possible, be given to patients without first confirming the diagnosis, and should not be used to treat megaloblastic anaemia of pregnancy.

Back to top

ADVERSE EFFECTS:

Allergy hypersensitivity reactions have occurred rarely following the administration of cobalamins. Indiscriminate use of cobalamins may mask the precise diagnosis of folate deficiency.

Back to top

NAME AND ADDRESS OF SPONSOR:

Division of Orthomolecular Medisearch Laboratories Pty Ltd.
5 / 20-30 Malcolm Rd.,
Braeside, VIC. 3195 Australia.
Tel: (03) 9587 3948. Fax: (03) 9587 1720
International Telephone Prefix: 61

Date of first inclusion in the ARTG:
8 October 1991

Date of most recent amendment:
15 September 2011

Biological Therapies

AUST R 22435

Code: BMB102

Back to top

CMI provided by MIMS Australia, January 2015  

Related information - Methylcobalamin Injection

Audience:
       

(Medicine)
30 Oct 2012 Information on medicines available in Australia containing co-methylcobalamin, including our latest evidence-based information and resources for health professionals and consumers. The active ingredient is the chemical in a medicine that makes it work. Medicines that contain the same active ingredient can be available under more than one brand name. Brands include both active ingredients and inactive ingredients. You'll find information about brands of medicines that contain co-methylcobalamin below, including their consumer medicine information (CMI) leaflets.