PHARMACOLOGICAL/CAL CLASSIFICATION A 22.1.4 Vitamins, other
PHARMACOLOGICAL ACTION Vitamin B12 promotes synthesis of amino-acids and nucleo-proteins. It has a lipotropic and liver protective action. Vitamin B12 is essential for normal haematopoiesis.
INDICATIONS Pernicious and other macrocytic anaemias, disorders of the erythropoiesis mechanism, neurological conditions such as neuritis and neuralgia, delayed convalescence, geriatric disturbances such as depression and apathy, sprue, coeliac disease, anorexia and debility in children
CONTRA-INDICATIONS See warning.
WARNING Cyanocobalamin should not be given before a diagnosis has been fully established because of the possibility of subacute degeneration of the spinal cord.
DOSAGE AND DIRECTIONS FOR USE 1 000 µg (1 mL) per injection intramuscularly once or several times per week over a sufficiently long period
SIDE-EFFECTS AND SPECIAL PRECAUTIONS Cyanocobalamin is usually well tolerated. Rarely, allergic reactions have been reported after injection.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT No symptoms of overdosage known.
Treatment is symptomatic and supportive.
CONDITIONS OF REGISTRATION Not yet registered
IDENTIFICATION Clear pink liquid
PRESENTATION Injections: 1 vial of 10 mL
STORAGE INSTRUCTIONS Store below 25°C and protect from light
KEEP OUT OF REACH OF CHILDREN.
REFERENCE NUMBER H2070 (Act 101/1965)
NAME AND BUSINESS ADDRESS OF THE APPLICANT NORISTAN LIMITED 326 MARKS STREET, WALTLOO, PRETORIA
DATE OF PUBLICATION OF THIS PACKAGE INSERT 16 November 1984
ETHIMED Division of NORISTAN LIMITED, WALTLOO, PRETORIA D 210/01