Hydroxocobalamin 1 mg/ml solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Hydroxocobalamin

Available from:

G.L. Pharma GmbH

ATC code:

B03BA; B03BA03

INN (International Name):

Hydroxocobalamin

Dosage:

1 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Vitamin B12 (cyanocobalamin and analogues); hydroxocobalamin

Authorization status:

Marketed

Authorization date:

2018-08-03

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HYDROXOCOBALAMIN 1MG/ML SOLUTION FOR INJECTION
Hydroxocobalamin (as hydroxocobalamin acetate)
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 further questions, ask your doctor or pharmacist.

If any of the side effects become serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor or pharmacist.
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 use Hydroxocobalamin Injection
3.
How to use Hydroxocobalamin Injection
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
Hydroxocobalamin injection is an injection which contains
hydroxocobalamin acetate. It is
used to treat deficiency of vitamin B12 which causes various types of
anaemia (reduction in
the number of red blood cells). Most people get enough vitamin B12
from their food, but if
you have had stomach surgery, or certain diseases of the intestines,
or a restricted diet, you
may not absorb enough vitamin B12. It is used to treat conditions
called tobacco amblyopia
and Leber’s optic atrophy, which result in dimming of vision.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE HYDROXOCOBALAMIN INJECTION
DO NOT USE HYDROXOCOBALAMIN INJECTION

If you know you are allergic to hydroxocobalamin injection or any of
the other
ingredients present in this medicine (see section 6 of this leaflet)
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Hydroxocobalamin Injection:

If you have suffered from any heart problems.

If you have megaloblastic anaemia. This is a blood disorder where y

Summary of Product characteristics

Health Products Regulatory Authority
26 September 2022
CRN00D44Y
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hydroxocobalamin 1mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml of solution for injection contains 1.045 mg hydroxocobalamin
acetate equivalent to 1 mg hydroxocobalamin (vitamin B
12
).
1mg/ml of hydroxocobalamin equals 1000 micrograms/ml.
Excipients with known effect
Each ml of solution contains 0.5 mg sodium hydroxide and 8mg sodium
chloride
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection (injection)
Red, clear solution
pH 4.3 to 4.7
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
Intramuscular injection
Posology
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 B12
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.
4.3 CONTRAINDICATIONS
Hypersensitivity to Hydroxocobalamin or to any of the ingredients i