This document discusses vitamin B12 (cobalamin) injections. It provides information on the preparation, dosage, administration, mechanism of action, storage, uses, side effects and good manufacturing practices for methylcobalamin injections. Methylcobalamin injections contain 500μg of methylcobalamin and are used to treat peripheral neuropathies and megaloblastic anemia by improving blood and nerve cell metabolism. They are usually administered intramuscularly or intravenously 3 times per week with dosage adjustments based on age and symptoms.

1. oMUHAMMAD AFIQ RAFI’UDDIN BIN AHMAD RAJI 57153313118
oNURUL FATHINEE BINTI ABD RAZAK 57153313243
oNURUL ATIRAH BINTI RANI 57153313142
oWAN RASYIDAH BINTI WAN KAMARUDDIN 57153313020
oVICKY LIONG WEI CHYI 57153313092
oSYAZWANI BINTI JUNOH 57153313265

2. INTRODUCTION
• Vitamin is generally known substance that can be absorbed from our
dietary consumption.
• In order to increase the absorption or daily uptake of those vitamins we
offer take supplement such as vitamin c supplement.
• Has various type of vitamin.
• Drug name: B12 vitamin -> Cobalamin
• Route of administration: -
– Oral
– Parenteral (Intramuscular and Intravenous)
• Preparation need sterilization procedure
• Dose daily need : 2.5 microgram

3. • Two main classes :-
– Water-soluble(are freely move vitamin through the body and excess
are excrete by kidney)
– Fat-soluble ( are stored in the body cell’s and not excrete easily as the
water soluble vitamin)
Water-soluble Fat-soluble
B1-Thiamine Vitamin A
B2-Riboflavin Vitamin D
B3-Niacin Vitamin E
Pantothenic Acid Vitamin K
Biotin
B6-Pyridoxine
Folic Acid
B12-Cobalamin
Ascorbic Acid

4. Preparation
• A sterile solution of 500μg Mecobalamin and 50mg D-Mannitol in
water for injections for 1 ampoule. It is a clear, red liquid with the
pH range 5.3-7.3 and the osmotic pressure ratio about 1 relative to
isotonic sodium chloride solution.
• Description:
– Mecobalamin occurs as dark red crystals or crystalline
powder. It is sparingly soluble in water, slightly soluble in
ethanol (99.5), and practically insoluble in acetonitrile. It is
affected by light.
– D-mannitol is an osmotic diuretic, manufactured by
electrolytic reduction of glucose.
– Water for injections (Syn. Aqua ad Injectabilia; Aqua pro
Injectionibus) is a sterillised distilled water free from
pyrogens.

5. Main tests for Vitamin B12 Deficiency
1. Serum B12
-The normal range is 200 to 900 pg/ml.
2. Homocysteine level.
-High homocysteine levels are an indicator that the usable
vitamin B12 is low, should be supplemented.
3. Methylmalonic acid,MMA
-Along with homocysteine, helps diagnose an early or mild
B12 deficiency.
4. Holotranscobalamin
-This test is not done everywhere and is expensive but it’s the
best test because it measures usable B12.

6. Serum B12 Level Maintenance
• Optimal serum B12-Can be maintained with
methylcobalamin injections administered once per
month.
• To inject methylcobalamin deeper when
administering less frequent injections.
• The goal is to treat B12 deficiency and bring serum
B12 levels to a good range.

7. DIRECTION
Dosage and Administration
Injection:
Peripheral Neuropathies: The usual adult dosage is 1 amp, equivalent to
500 mcg of mecobalamin administered IM or IV 3 times a week. The dosage
should be adjusted according to age of patient and severity of symptoms.
Megaloblastic Anemia: The usual adult dosage is 1 amp, equivalent to 500
mcg of mecobalamin administered IM or IV 3 times a week. After
approximately 2 months of medication, the dose should be reduced to a
single administration of 1 amp at 1- to 3-month intervals for maintenance
therapy.

8. Mechanism of Action
Mecobalamin B12 contain co-enzyme with an active methyl base. It
participates in transmethylation reactions and is the most active of all B12
homologs in the body to nucleic acid, protein and lipid metabolism.
Acts to repair damaged nerve tissue in nerve disorder involved in
erythroblast maturation.
Thus,it acts to improve the status of the blood in megaloblastic anemia and
also on peripheral neuropathies.

9. STORAGE
• For the injection should be stored at room temperature in Light Protect Easy
(LPE).
LPE
•Remains protected from light until right before use.
•Features dual-function of labeling and packaging.
•1-2ml ampoules can be packed in a high speed line.

10. USES OF METHYLCOBALAMIN
• Aids in growth of healthy blood cells, nerve cells,
and proteins in the body
• Helps with metabolism of fats and carbohydrates
• Treatment for people who cannot absorb vitamin
B12
SIDE EFFECT
• Irritation at the injection site and/or skin rash
have been reported by some patients.

11. Good Manufacture Practice
• Containers and closures handled in a manner to prevent
contamination.
• Examination, approval of labels, labeling
• Strict control over labeling issue, and return to stock
• Written procedures, physical separation of labeling
operations
• Examination of materials before use
• Inspection of facilities immediately before
• Tamper resistant packaging (for OTC products)
• Expiration dating
• Quarantine before release
• Store under appropriate conditions

12. REFERENCE
• www.wisegeekhealth.com/what-are-the-most-common-
methylcobalamin-side-effects.htm
• http://www.defymedical.com/services/89-
methylcobalamin-vitamin-b-12-injection
• http://www.eisai.jp/medical/products/di/EPI/MBL_A
_EPI.pdf
• http://www.medsafe.govt.nz/consumers/cmi/w/Waterf
orInjectionPfizer.pdf