Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
It is advisable to confirm the diagnosis of Vitamin B12 deficiency before giving hydroxocobalamin; regular monitoring of the blood is recommended.
If megaloblastic anaemia fails to respond, folate metabolism should be investigated.
Doses in excess of 10 micrograms daily may produce a haematological response in patients with folate deficiency. Indiscriminate administration may mask the true diagnosis.
Cardiac arrhythmias secondary to hypokalaemia during initial therapy have been reported. Plasma potassium should therefore be monitored during this period.
Parenteral chloramphenicol may attenuate the effect of hydroxocobalamin in anaemia.
The serum concentration of hydroxocobalamin may be lowered.
The above interactions are unlikely to be of clinical significance but should be taken into account when performing assays for blood concentrations.
Vitamin B12 assays by microbiological techniques are invalidated by antimetabolites and most antibiotics.
Hydroxocobalamin injection should not be used for the treatment of megaloblastic anaemia of pregnancy.
Hydroxocobalamin is secreted into breast milk but is unlikely to harm the infant.
No data available.
Not relevant.
The following undesirable effects may occur with the use of hydroxocobalamin in the following frequencies: Very common (>1/10), Common (>1/100, <1/10), Uncommon (>1/1,000, <1/100), Rare (>1/10,000, <1/1,000), Very rare (<1/10,000), (cannot be estimated from the available data) are not known.
There are no modern clinical studies available that can be used to determine the frequency of undesirable effects. Therefore, all the undesirable effects listed are classed as “frequency unknown”.
The following effects have been reported and are listed below by body system:
Not Known: Reactive thrombocytosis can occur during the first weeks of use in megaloblastic anaemia.
Not Known: Hypersensitivity reactions including rash; itching; exanthema. Antibodies to hydroxocobalamin-transcobalamin II complex have developed during hydroxocobalamin therapy. Anaphylaxis
Not Known: Initial hypokalaemia
Not Known: Headache, paraesthesia, tremor.
Not Known: Arrhythmias secondary to hypokalaemia.
Not Known: Nausea, vomiting, diarrhoea.
Not Known: Fever, chills, hot flushes; dizziness; malaise; pain; Injection site reactions including injection site pain, injection site erythema, injection site pruritus, injection site' induration, and injection site swelling.
Not known: Acneiform and bullous eruptions
Not Known: Chromaturia
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
None stated.
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