Cobalin-H 1mg/1ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydroxocobalamin

Available from:

Advanz Pharma

ATC code:

B03BA03

INN (International Name):

Hydroxocobalamin

Dosage:

1mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09010200; GTIN: 5027229000067

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor
or pharmacist.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
The name of your medicine is Cobalin-H
1000 microgram/ml Injection, it will be referred
to as Cobalin-H Injection throughout the PIL for
ease hereafter.
WHAT IS IN THIS LEAFLET:
1.
What Cobalin-H Injection is and what it is
used for
2.
What you need to know before Cobalin-H
Injection is given
3.
How Cobalin-H Injection is given
4.
Possible side effects
5.
How to store Cobalin-H Injection
6.
Contents of the pack and other information
1. WHAT COBALIN-H INJECTION IS
AND WHAT IT IS USED FOR
This medicine contains hydroxocobalamin which
is a form of Vitamin B
12
. It is given for:
•
Addisonian pernicious anaemia (caused when
absorption of Vitamin B
12
from the stomach
is reduced).
•
Tobacco amblyopia (poor sight caused by
toxins such as tobacco).
•
Leber’s atrophy (degeneration of the optic
nerve resulting in loss of central vision).
•
Treatment/prevention of other macrocytic
anaemias due to deficiency in vitamin B
12
.
Vitamin B
12
is needed for physical growth and
development and for the formation of red blood
cells in the bone marrow. It is also required for
absorption of folic acid and carbohydrates from
food and for keeping the nerve (neurological)
system healthy.
The body only requires a small amount of the
vitamin daily so a deficiency may take months or
even years to develop. Eventually, the formation
of abnormally large red blood cells
(macrocytes)with reduced ability to carry oxygen
from enlarged cells (megaloblasts) in the bone
marrow, gives rise to anaemia. Symptoms of
Vitamin B
12
deficiency anaemia include sore
mouth and tongue, numbness and tingling in the
arms and legs, memory loss and depression.
This injection

Summary of Product characteristics

OBJECT 1
COBALIN-H INJECTION
Summary of Product Characteristics Updated 02-Mar-2018 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Cobalin-H
Hydroxocobalamin 1000 microgram/ml Injection
2. Qualitative and quantitative composition
Anhydrous hydroxocobalamin 1000microgram/ml.
For the full list of excipients, see section 6.1.
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
B
12
deficiency.
Treatment of tobacco amblyopia.
Treatment of Leber' s atrophy.
4.2 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 intramuscularly on alternate days
for one or
two weeks then 250 micrograms weekly until blood count is normal.
Maintenance:
1000 micrograms every two or three months.
_Addisonian pernicious anaemia and other macrocytic anaemias with
neurological involvement:_
Initially:
1000 micrograms on alternate days as long as improvement continues.
Maintenance:
1000 micrograms every two months.
_Prophylaxis of macrocytic anaemias associated with vitamin B_
_12 _
_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:
1000 micrograms daily by intramuscular injection for two weeks then
twice
weekly as long as improvement is maintained.
Maintenance:
1000 micrograms every three months or as required.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 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 megalob