Kenyan Health Patient Information Leaflet
Antidote [EPC]
Prophylaxis and treatment Vitamin B12deficiency; treatment of pernicious anaemia Clinical selection for Hydroxocobalamin should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC. Class context: Antidote [EPC]. Confirm site-specific dose, duration and monitoring before prescribing.
I.M. Initially repeated 5 times at 2-3 days interval then maintenance dose of 1g every 3 months
Adverse Reactions The following adverse reactions have been reported with hydroxocobalamin injection and other parenteral vitamin B12 products: Hypersensitivity reactions including anaphylactic shock, urticaria, rash, pruritus, flushing, and edema Injection site pain, erythema, and injection site reactions Headache and dizziness Nausea and diarrhea Fever and chills Rare cases of hypokalemia during intensive treatment of severe megaloblastic anemia Serious hypersensitivity reactions, including anaphylaxis, may occur in sensitive patients. To report suspected adverse reactions, contact Xseer Pharmaceuticals at (888) 658-8005 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Store as labelled. Keep out of reach of children.