INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo NORIVITE 12 injections

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

NORIVITE 12 injections

COMPOSITION
Per mL:
Cyanocobalamin 1 000 µg
Preservative: Benzyl alcohol 1,5% v/v

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

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