NEO-CYTAMEN Solution for injection Ref.[49889] Active ingredients: Vitamin B12a

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: RPH Pharmaceuticals AB, Box 603, 101 32 Stockholm, Sweden

4.1. Therapeutic indications

Addisonian pernicious anaemia.

Prophylaxis and treatment of other macrocytic anaemias associated with vitamin B12 deficiency.

Tobacco amblyopia and Leber’s optic atrophy.

4.2. Posology and method of administration

Route of administration

Intramuscular.

Adults and Children

Addisonian pernicious anaemia and other macrocytic anaemias without neurological involvement

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

Maintenance: 1000mcg every two to three months.

Addisonian pernicious anaemia and other macrocytic anaemias with neurological involvement

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

Maintenance: 1000mcg every two months.

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

1000mcg every two to three months.

Tobacco amblyopia and Leber’s optic atrophy

Initially: 1000mcg or more daily by intramuscular injection for two weeks. Then twice weekly as long as improvement is occurring.

Maintenance: 1000mcg monthly.

4.9. Overdose

Treatment is unlikely to be needed in cases of overdosage.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Protect from light. Do not store above 25°C.

6.5. Nature and contents of container

1ml clear, one-point cut (OPC) glass Type 1 Ph Eur ampoules packed in cartons of 5 ampoules.

6.6. Special precautions for disposal and other handling

Not applicable.

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