COBALIN-H INJECTION 1000MCG/ML
Active substance: HYDROXOCOBALAMIN
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cobalin-H
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Anhydrous hydroxocobalarnin 1000mcg/ml.
3
PHARMACEUTICAL FORM
Injection
4
4.1
CLINICAL PARTICULARS
Therapeutic indications Treatment of Addisonian pernicious anaemia. Prophylaxis and treatment of other macrocytic anaemias due to vitamin B12 deficiency. Treatment of tobacco amblyopia. Treatment of Leber s atrophy.
4.2
Posology and method of administration 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 intramuscularly on alternate days for one or two weeks then 250 micrograms weekly until blood count is normal. 1000 micrograms every two or three months.
Maintenance:
Addisonian pernicious anaemia and other macrocytic anaemias with neurological involvement: Initially: 1000 micrograms on improvement continues. alternate days as long as
Maintenance:
1000 micrograms every two months.
Prophylaxis of macrocytic anaemias associated with vitamin B12 deficiency resulting from gastrectomy, ileal resection, certain ma/absorption states and vegetarianism: 1000 micrograms every two or three months. Tobacco amblyopia and Lebers optic atrophy: Initially: 1000 micrograms daily by intramuscular injection for two weeks then twice weekly as long as improvement is maintained. 1000 micrograms every three months or as required.
Maintenance:
4.3
Contraindications Sensitivity to hydroxocobalamin / vitamin B12.
4.4
Special warnings and precautions for use Cobalin-H should not be given before a megaloblastic marrow has been demonstrated. Regular monitoring of the blood is advisable. Doses of hydroxocobalamin greater than 10 micrograms daily may produce a haematological response in patients with folate deficiency. Indiscriminate use may mask the exact diagnosis. Cardiac arrhythmias secondary to hypokalaemia have been reported during initial therapy and plasma potassium should, therefore, be monitored during this period.
4.5
Interaction with other medicinal products and other forms of interaction The serum concentration of hydroxocobalamin may be reduced by concurrent administration of oral contraceptives. Chlorphenicol-treated patients may respond poorly to hydroxocobalamin. Vitamin B12 assays by microbiological techniques are invalidated by antimetabolites and most antibiotics.
4.6
Pregnancy and lactation Hydroxocobalamin should not be used to treat megaloblastic anaemia of pregnancy.
4.7
Effects on ability to drive and use machines None stated.
4.8
Undesirable effects The following effects have been reported and are listed below by body system:
Disorders of the immune system: Rare: Very rare: Allergic hypersensitivity reactions Anaphylaxis
Gastro intestinal disorders: Frequency Not Known: Nausea General disorders: Frequency Not Known: Fever, dizziness, Injection site disorders Neurological disorders: Frequency Not Known: Headache
4.9
Overdose Treatment is unlikely to be needed in cases of overdosage.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Vitamin B12 ATC classification: B03B A03
5.2
Pharmacokinetic properties 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.
5.3
Preclinical safety data 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.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Sodium dihydrogen orthophosphate Sodium chloride Sodium Hydroxide (for pH adjustment) Hydrochloric Acid (for pH adjustment) Water for Injections
6.2
Incompatibilities None stated.
6.3
Shelf life 60 months.
6.4
Special precautions for storage Protect from light. Store below 25C.
6.5
Nature and contents of container Cobalin-H is supplied in clear 1ml Type I glass ampoules in cartons of 5 or 10.
6.6
Special precautions for disposal None stated.
7
MARKETING AUTHORISATION HOLDER
AMDIPHARM PLC REGENCY HOUSE MILES GRAY ROAD BASILDON ESSEX SS14 3AF UNITED KINGDOM
8
MARKETING AUTHORISATION NUMBER(S)
PL 20072/0217
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18th June 1993 / 6th November 1998
10
DATE OF REVISION OF THE TEXT
20/03/2013
1
NAME OF THE MEDICINAL PRODUCT
Cobalin-H
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Anhydrous hydroxocobalarnin 1000mcg/ml.
3
PHARMACEUTICAL FORM
Injection
4
4.1
CLINICAL PARTICULARS
Therapeutic indications Treatment of Addisonian pernicious anaemia. Prophylaxis and treatment of other macrocytic anaemias due to vitamin B12 deficiency. Treatment of tobacco amblyopia. Treatment of Leber s atrophy.
4.2
Posology and method of administration 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 intramuscularly on alternate days for one or two weeks then 250 micrograms weekly until blood count is normal. 1000 micrograms every two or three months.
Maintenance:
Addisonian pernicious anaemia and other macrocytic anaemias with neurological involvement: Initially: 1000 micrograms on improvement continues. alternate days as long as
Maintenance:
1000 micrograms every two months.
Prophylaxis of macrocytic anaemias associated with vitamin B12 deficiency resulting from gastrectomy, ileal resection, certain ma/absorption states and vegetarianism: 1000 micrograms every two or three months. Tobacco amblyopia and Lebers optic atrophy: Initially: 1000 micrograms daily by intramuscular injection for two weeks then twice weekly as long as improvement is maintained. 1000 micrograms every three months or as required.
Maintenance:
4.3
Contraindications Sensitivity to hydroxocobalamin / vitamin B12.
4.4
Special warnings and precautions for use Cobalin-H should not be given before a megaloblastic marrow has been demonstrated. Regular monitoring of the blood is advisable. Doses of hydroxocobalamin greater than 10 micrograms daily may produce a haematological response in patients with folate deficiency. Indiscriminate use may mask the exact diagnosis. Cardiac arrhythmias secondary to hypokalaemia have been reported during initial therapy and plasma potassium should, therefore, be monitored during this period.
4.5
Interaction with other medicinal products and other forms of interaction The serum concentration of hydroxocobalamin may be reduced by concurrent administration of oral contraceptives. Chlorphenicol-treated patients may respond poorly to hydroxocobalamin. Vitamin B12 assays by microbiological techniques are invalidated by antimetabolites and most antibiotics.
4.6
Pregnancy and lactation Hydroxocobalamin should not be used to treat megaloblastic anaemia of pregnancy.
4.7
Effects on ability to drive and use machines None stated.
4.8
Undesirable effects The following effects have been reported and are listed below by body system:
Disorders of the immune system: Rare: Very rare: Allergic hypersensitivity reactions Anaphylaxis
Gastro intestinal disorders: Frequency Not Known: Nausea General disorders: Frequency Not Known: Fever, dizziness, Injection site disorders Neurological disorders: Frequency Not Known: Headache
4.9
Overdose Treatment is unlikely to be needed in cases of overdosage.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Vitamin B12 ATC classification: B03B A03
5.2
Pharmacokinetic properties 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.
5.3
Preclinical safety data 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.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Sodium dihydrogen orthophosphate Sodium chloride Sodium Hydroxide (for pH adjustment) Hydrochloric Acid (for pH adjustment) Water for Injections
6.2
Incompatibilities None stated.
6.3
Shelf life 60 months.
6.4
Special precautions for storage Protect from light. Store below 25C.
6.5
Nature and contents of container Cobalin-H is supplied in clear 1ml Type I glass ampoules in cartons of 5 or 10.
6.6
Special precautions for disposal None stated.
7
MARKETING AUTHORISATION HOLDER
AMDIPHARM PLC REGENCY HOUSE MILES GRAY ROAD BASILDON ESSEX SS14 3AF UNITED KINGDOM
8
MARKETING AUTHORISATION NUMBER(S)
PL 20072/0217
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18th June 1993 / 6th November 1998
10
DATE OF REVISION OF THE TEXT
20/03/2013
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
