Hydroxocobalamin Panpharma

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Hydroxocobalamin acetate 1 mg/mL

Available from:

Boucher & Muir (New Zealand) Limited t/a BNM Group

INN (International Name):

Hydroxocobalamin acetate 1 mg/mL

Dosage:

1 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Hydroxocobalamin acetate 1 mg/mL Excipient: Acetic acid Sodium acetate Sodium chloride Water for injection

Units in package:

Ampoule, glass, Type I, brown, 1 mL ampoules in cardboard carton, 3 dose units

Class:

General sale

Prescription type:

General sale

Manufactured by:

Sanofi Chimie

Therapeutic indications:

Addisonian pernicious anaemia. Prophylaxis and treatment of other macrocytic anaemias associated with vitamin B12 deficiency. Tobacco amblyopia and Leber's optic atrophy.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, Type I, brown, 1 mL ampoules in cardboard carton - 3 dose units - 3 years from date of manufacture stored at or below 25°C

Authorization date:

2005-09-07

Patient Information leaflet

1
HYDROXOCOBALAMIN PANPHARMA
Consumer Medicine Information
HYDROXOCOBALAMIN PANPHARMA
_HYDROXOCOBALAMIN ACETATE (VITAMIN B12)_
Solution for injection 1 mg/mL
WHAT IS IN THIS LEAFLET
Please
read
this
leaflet
carefully
before
you
are
given
HYDROXOCOBALAMIN
PANPHARMA.
This
leaflet
answers
some
common
questions
about
HYDROXOCOBALAMIN
PANPHARMA. It does not contain all the available information. The most
up-to-date
Consumer Medicine Information can be downloaded from
www.medsafe.govt.nz.
Reading this leaflet does not take the place of talking to your doctor
or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using
HYDROXOCOBALAMIN PANPHARMA against the benefits this medicine is
expected to
have for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
USING
THIS
MEDICINE,
ASK
YOUR
DOCTOR
OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT
HYDROXOCOBALAMIN
PANPHARMA
IS
USED FOR
HYDROXOCOBALAMIN
PANPHARMA
contains
hydroxocobalamin
acetate
(vitamin
B
12
).
Vitamin B
12
is important for the function of several key body enzymes. It is
needed for
physical growth and development and for the formation of red blood
cells in the bone
marrow. This vitamin is also needed for the body to absorb folic acid
and carbohydrates
in the diet and for keeping the nervous system healthy.
Only small daily amounts of vitamin B
12
are required. Deficiency of vitamin B
12
may take
months or years to develop, but eventually leads to anaemia, a
condition in which the
amount of oxygen-carrying pigment (haemoglobin) in the blood is
reduced. Symptoms of
vitamin B
12
deficiency anaemia include sore mouth and tongue, numbness and
tingling in
the arms and legs, memory loss and depression. The most common type of
vitamin B
12
2
HYDROXOCOBALAMIN PANPHARMA
deficiency anaemia is Addisonian pernicious anaemia, in which
absorption of vitamin B
12
from the stomach does not take place properly.
HYDROXOCOBALAMIN PANPHARMA is used to replace the body’s low vitamin
B
12
levels caused by:
▪
Addisonia

Summary of Product characteristics

1
HYDROXOCOBALAMIN PANPHARMA
HYDROXOCOBALAMIN ACETATE SOLUTION FOR INJECTION 1 MG/ML
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
HYDROXOCOBALAMIN PANPHARMA
Solution for injection 1 mg/mL
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydroxocobalamin acetate 1 mg/mL
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
DOSE AND METHOD OF ADMINISTRATION
HYDROXOCOBALAMIN
PANPHARMA
injection
is
to
be
administered
intramuscularly.
The following dosage schemes are suitable for adults and children.
ADDISONIAN PERNICIOUS ANAEMIA AND OTHER MACROCYTIC ANAEMIAS WITHOUT
NEUROLOGICAL
INVOLVEMENT.
Initially, 250 to 1,000 micrograms intramuscularly on alternate days
for one to two weeks,
then 250 micrograms weekly until the blood count is normal.
Maintenance: 1,000 micrograms every two or three months.
ADDISONIAN PERNICIOUS ANAEMIA AND OTHER MACROCYTIC ANAEMIAS WITH
NEUROLOGICAL
INVOLVEMENT.
2
HYDROXOCOBALAMIN PANPHARMA
HYDROXOCOBALAMIN ACETATE SOLUTION FOR INJECTION 1 MG/ML
Initially: 1,000 micrograms on alternate days as long as improvement
is occurring.
Maintenance: 1,000 micrograms every two months.
PROPHYLAXIS OF MACROCYTIC ANAEMIA ASSOCIATED WITH VITAMIN B
12 DEFICIENCY RESULTING
FROM GASTRECTOMY, SOME MALABSORPTION SYNDROMES AND STRICT
VEGETARIANISM.
1,000 micrograms every two or three months.
TOBACCO AMBLYOPIA AND LEBER’S OPTIC ATROPHY.
Initially: 1,000 micrograms or more daily by intramuscular injection
for two weeks then
twice weekly as long as improvement is occurring.
Maintenance: 1,000 micrograms monthly.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Known sensitivity to cobalt.
HYDROXOCOBALAMIN PANPHARMA should not be used for the treatment of
megaloblastic anaemia in pregnancy
(see 4.4 Spe