Hydroxocobalamin Solution for Injection 1mg/ml

País: Malta

Idioma: inglés

Fuente: Malta Medicines Authority

Ingredientes activos:

HYDROXOCOBALAMIN ACETATE

Disponible desde:

Mercury Pharmaceuticals Limited Capital House, 85 King William Street, London EC4N 7BL, United Kingdom

Código ATC:

B03BA03

Designación común internacional (DCI):

HYDROXOCOBALAMIN ACETATE 1 mg/ml

formulario farmacéutico:

SOLUTION FOR INJECTION

Composición:

HYDROXOCOBALAMIN ACETATE 1 mg/ml

tipo de receta:

POM

Área terapéutica:

ANTIANEMIC PREPARATIONS

Estado de Autorización:

Withdrawn

Fecha de autorización:

2006-03-29

Información para el usuario

5039097
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Hydroxocobalamin 1mg/ml Solution for
Injection. It will be referred to as Hydroxocobalamin Injection for
ease of
use hereafter.
What is in this leaflet:
1. What Hydroxocobalamin Injection is and what it is used for
2. What you need to know before you are given Hydroxocobalamin
injection
3. How Hydroxocobalamin injection is given to you
4. Possible side effects
5. How to store Hydroxocobalamin injection
6. Contents of the pack and other information
1. WHAT HYDROXOCOBALAMIN 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

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydroxocobalamin 1mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance
Quantity
Reference Standard
Hydroxocobalamin Acetate
1.04 mg
Ph Eur
equivalent to
Hydroxocobalamin
1.00 mg
An overage of 7.5% has been incorporated
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection
4. CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Addisonian
pernicious
anaemia.
Prophylaxis
and
treatment
of
other
macrocytic
anaemias associated with vitamin B12 deficiency. Tobacco amblyopia and
Leber’s
optic atrophy
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and Paediatric population
The following dosage are suitable for adults and children.
Addisonian pernicious anaemias and other macrocytic anaemias without
neurological
involvement.
Initially 250 to 1000 micrograms intramuscularly on alternate days for
one or two
weeks, then 250 micrograms weekly until the blood count is normal
Maintenance: 1000 micrograms every two to three months
Addisonian pernicious anaemia and other macrocytic anaemias with
neurological
involvement
Initially:1000 micrograms on alternate days as long as improvement is
occurring.
Maintenance:1000 micrograms every two of three months.
Prophylaxis of macrocytic anaemia associated with vitamin B
12
deficiency resulting
from gastrectomy, some malabsorption syndromes and strict
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 occurring.
Maintenance: 1000 micrograms every one to three months as required.
Method of Administration
Intramuscular injection
4.3.
CONTRAINDICATIONS
Hypersensitivity to Hydroxocobalamin or to any of the ingredient in
this preparation.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
It is advisable to confirm the diagnosis of Vitamin B12 deficiency
before giving
hydroxocob