COBALIN Injection (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Cobalin-H. Hydroxocobalamin 1000 microgram/ml Injection.
Qualitative and quantitative composition
Anhydrous hydroxocobalamin 1000microgram/ml. For the full list of excipients, see section 6.1.
Pharmaceutical form
Injection.
Therapeutic indications
Treatment of Addisonian pernicious anaemia. Prophylaxis and treatment of other macrocytic anaemias due to vitamin B<sub>12</sub> deficiency. Treatment of tobacco amblyopia. Treatment of Lebers atrophy. ...
Posology and method of administration
Posology The following dosages are suitable for children and adults. Addisonian pernicious anaemia and other macrocytic anaemias without neurological involvement: Initially: 250 micrograms to 1000 micrograms ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
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 ...
Interaction with other medicinal products and other forms of interaction
Chloramphenicol Parenteral chloramphenicol may attenuate the effect of hydroxocobalamin in anaemia. Oral contraceptives The serum concentration of hydroxocobalamin may be lowered. The above interactions ...
Fertility, pregnancy and lactation
Pregnancy Hydroxocobalamin injection should not be used for the treatment of megaloblastic anaemia of pregnancy. Breast-feeding Hydroxocobalamin is secreted into breast milk but is unlikely to harm the ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
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), ...
Overdose
Treatment is unlikely to be needed in case of overdose.
Pharmacodynamic properties
Pharmacotherapeutic group: Antianaemic preparations Vitamin B<sub>12</sub> ATC code: B03BA03 Hydroxocobalamin is used in the treatment and prevention of Vitamin B<sub>12</sub> deficiency. For adults, ...
Pharmacokinetic properties
Distribution Hydroxocobalamin is extensively bound to specific plasma proteins (transcobalamins); transcobalamin II appears to be involved in the rapid transport of the cobalamins to tissues. Elimination ...
Preclinical safety data
There is no additional information relevant to the prescriber.
List of excipients
Sodium dihydrogen orthophosphate Sodium chloride Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Incompatibilities
None stated.
Shelf life
Shelf life: 36 months.
Special precautions for storage
Protect from light. Store below 25°C.
Nature and contents of container
This medicine is supplied in clear 1ml Type I glass ampoules in cartons of 5 or 10.
Special precautions for disposal and other handling
None stated.
Marketing authorization holder
Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK
Marketing authorization number(s)
PL 20072/0217
Date of first authorization / renewal of the authorization
18<sup>th</sup> June 1993 / 6<sup>th</sup> November 1998
Date of revision of the text
26/02/2018
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