Hydroxocobalamin

Hydroxocobalamin 1mg/ml Solution for Injection

1ml of solution for injection contains 1.045 mg hydroxocobalamin acetate equivalent to 1 mg hydroxocobalamin (vitamin B₁₂). 1mg/ml of hydroxocobalamin equals 1000 micrograms/ml.

Excipients with known effect

Each ml of solution contains 0.5 mg sodium hydroxide and 8mg sodium chloride

For the full list of excipients, see section 6.1.

Solution for injection (injection)

Red, clear solution

pH 4.3 to 4.7

Addisonian pernicious anaemia. Prophylaxis and treatment of other macrocytic anaemias associated with vitamin B12 deficiency. Tobacco amblyopia and Leber's optic atrophy

Intramuscular injection

Posology

Adults and Children

Addisonian pernicious anaemias and other macrocytic anaemias without neurological involvement.

Initially 250 to 1000 micrograms intramuscularly on alternate days for one or two weeks, then 250 micrograms weekly until the blood count is normal

Maintenance: 1000 micrograms every two to three months

Addisonian pernicious anaemia and other macrocytic anaemias with neurological involvement

Initially:1000 micrograms on alternate days as long as improvement is occurring.

Maintenance:1000 micrograms every two or three months.

Prophylaxis of macrocytic anaemia associated with vitamin B12 deficiency resulting from gastrectomy, some malabsorption syndromes and strict vegetarianism

1000 micrograms every two or three months.

Tobacco amblyopia and Leber's optic atrophy

Initially:1000 micrograms daily by intramuscular injection for two weeks then twice weekly as long as improvement is occurring.

Maintenance: 1000 micrograms every one to three months as required.

Hypersensitivity to Hydroxocobalamin or to any of the ingredients in this preparation.

Hydroxocobalamin Injection should not be used for the treatment of megaloblastic anaemia of pregnancy unless vitamin B12 deficiency has been demonstrated.

The dosage schemes given above are normally satisfactory, but regular examination of the blood is advisable.

If megaloblastic anaemia fails to respond to hydroxocobalamin, 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.

The haematological and neurological state should be monitored regularly to ensure adequacy of therapy.

Platelet count should be monitored during the first weeks of use in megaloblastic anaemia due to the possible occurrences of reactive thrombocytosis.

This injection contains less than 1mmol (23mg) of sodium per 1ml (essentially 'sodium-free')

Chloramphenicol-treated patients may respond poorly to Hydroxocobalamin injection.

Serum concentrations of hydroxocobalamin may be lowered by oral contraceptives.

The above interactions are unlikely to have clinical significance. Antimetabolites and most antibiotics invalidate Vitamin B12 assays by microbiological techniques.

Hydroxocobalamin injection should not be used for the treatment of megaloblastic anaemia of pregnancy unless vitamin B12 deficiency has been demonstrated.

Hydroxocobalamin injection is secreted into the breast milk but is unlikely to harm the infant, and may be beneficial if the mother and infant are vitamin B12 deficient.

No studies on fertility have been performed.

None known

The following effects have been reported and are listed below by body system:

Reporting of suspected adverse reactions

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 at: www.mhra.gov.uk/yellowcard .

Treatment is unlikely to be required in the case of overdosage.

Vitamin B₁₂

ATC classification: B03BA03

An intramuscular injection of hydroxocobalamin produces higher serum levels than the same dose of cyanocobalamin and these levels are well maintained.

Vitamin B₁₂ is extensively bound to specific plasma proteins called transcobalamins; transcobalamin II appears to be involved in the rapid transport of the cobalamins to tissues. It is stored in the liver, excreted in the bile, and undergoes enterohepatic recycling; part of a dose is excreted in the urine, most of it in the first 8 hours. Vitamin B12 diffuses across the placenta and appears in breast milk.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.

Sodium hydroxide

Glacial acetic acid

Sodium chloride

Water for injection

In the absence of compatibility studies, this product must not be mixed with other medicinal products

18 months

Do not store above 25°C

Do not freeze

Store in the original package in order to protect from light.

Clear glass ampoules, 5 x 1 ml

Single use only, discard any unused content

G.L. Pharma GmbH

Schlossplatz 1

8502, Lannach

Austria

PL 21597/0060

18/06/2018

13/07/2018