B12(methylcobalamin) injection

procedure, side effect ,preparation,Good manufacturing product

1. METHYLCOBALAMIN INJECTION MUHAMMAD AFIQ RAFI’UDDIN BIN AHMAD RAJI 57153313118 NURUL FATHINEE BINTI ABD RAZAK 57153313243 NURUL ATIRAH BINTI RANI 57153313142 WAN RASYIDAH BINTI WAN KAMARUDDIN 57153313020 VICKY LIONG WEI CHYI 57153313092 SYAZWANI 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 500 μ g 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 I njectionibus ) is a sterillised distilled water free from pyrogens .

5. Main tests for Vitamin B12 Deficiency Serum B12 -The normal range is 200 to 900 pg/ml. Homocysteine level. - High homocysteine levels are an indicator that the usable vitamin B12 is low, should be supplemented. Methylmalonic acid,MMA -Along with homocysteine , helps diagnose an early or mild B12 deficiency. 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. 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. STORAGE

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/WaterforInjectionPfizer.pdf