COBALIN-H INJECTION 1000MCG/ML

Active substance: HYDROXOCOBALAMIN

View full screen / Print PDF » Download PDF ⇩

Transcript
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

CLINICAL PARTICULARS

4.1

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:

Maintenance:

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.

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 Leber’s optic atrophy:
Initially:

Maintenance:

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.

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:

Allergic hypersensitivity reactions

Very rare:

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

PHARMACOLOGICAL PROPERTIES

5.1

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

PHARMACEUTICAL PARTICULARS

6.1

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
36 months

6.4

Special precautions for storage
Protect from light. Store below 25°C.

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

Expand view ⇕

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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web1)