VITA-B12 INJECTION hydroxocobalamin acetate 1mg/ 1 mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hydroxocobalamin acetate, Quantity: 1.044 mg

Available from:

Amdipharm Mercury Australia Pty Ltd

INN (International Name):

Hydroxocobalamin acetate

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; glacial acetic acid; sodium chloride

Administration route:

Intramuscular

Units in package:

3 x 1mL ampoules

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Prophylaxis and treatment of pernicious (Addisonian) anaemia and other macrocytic anaemias associated with vitamin B12 deficiency. Treatment of optic neuropathies such as tobacco amblyopia and Leber's optic atrophy.

Product summary:

Visual Identification: clear pale red liquid; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2012-03-23

Patient Information leaflet

VITA-B12 INJECTION
_1 MG/1 ML_
_hydroxocobalamin (as acetate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Vita-B12 Injection.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor or pharmacist
has weighed the risks of you being
given hydroxocobalamin against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT VITA-B12
INJECTION IS USED FOR
Vita-B12 Injection is used for the
prevention and treatment of anaemias
associated with vitamin B12
deficiency. It is also used to treat
diseases of nerves in the eyes.
Vita-B12 Injection is a form of
vitamin B12.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY VITA-B12
INJECTION HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is not addictive.
BEFORE YOU ARE GIVEN
VITA-B12 INJECTION
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN VITA-B12
INJECTION IF YOU HAVE HAD AN ALLERGY
TO:
•
any medicine containing
hydroxocobalamin
•
any of the ingredients listed at the
end of this leaflet
•
cobalt.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty breathing;
swelling of the face, lips, tongue or
other parts of the body; skin rash,
itching or hives.
YOU MUST NOT BE GIVEN
HYDROXOCOBALAMIN TO TREAT
MEGALOBLASTIC ANAEMIA OF
PREGNANCY (THIS IS A TYPE OF
ANAEMIA USUALLY CAUSED BY THE
DEFICIENCY OF ANOTHER VITAMIN
CALLED FOLIC ACID).
YOU MUST NOT BE GIVEN THIS
MEDICINE AFTER THE EXPIRY DATE
PRINTED ON THE PACK OR IF THE
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING.
If it has expired or is damaged return
it to your pharmacist for disposal.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD BE GIVEN THIS MEDICINE, TALK
TO YOUR DOCTOR.
_BEFORE YOU ARE GIVEN IT_
TE

Summary of Product characteristics

VITA-B12 INJECTION
1 AUSTRALIAN PRODUCT INFORMATION
VITA-B12 INJECTION (HYDROXOCOBALAMIN ACETATE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Hydroxocobalamin (as acetate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vita-B12
Injection
1
mg/mL
contains
hydroxocobalamin
acetate
equivalent
to
hydroxocobalamin 1 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Vita-B12 Injection solution is a clear pale red liquid. The pH of the
solution is approximately
4.0.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis and treatment of pernicious (Addisonian) anaemia and other
macrocytic
anaemias associated with vitamin B
12
deficiency. Treatment of optic neuropathies such as
tobacco amblyopia and Leber's optic atrophy.
4.2 DOSE AND METHOD OF ADMINISTRATION
This product contains no antimicrobial agent. It is for single use in
one patient only. Discard
any residue.
Vita-B12 Injection is to be administered intramuscularly. The
following dosage schemes are
suitable for adults and children.
VITA-B12 INJECTION
2
ADDISONIAN PERNICIOUS ANAEMIA AND OTHER MACROCYTIC ANAEMIAS WITHOUT
NEUROLOGICAL
INVOLVEMENT_ _
_INITIALLY_:
250 to 1,000 microgram intramuscularly on alternate days for one to
two weeks,
then 250 microgram weekly until the blood count is normal.
_MAINTENANCE_:
1,000 microgram every two or three months.
ADDISONIAN PERNICIOUS ANAEMIA AND OTHER MACROCYTIC ANAEMIAS WITH
NEUROLOGICAL
INVOLVEMENT
_INITIALLY_:
1,000 microgram on alternate days for one to two weeks.
_MAINTENANCE_:
1,000 microgram every two months.
PROPHYLAXIS OF MACROCYTIC ANAEMIA ASSOCIATED WITH VITAMIN B12
DEFICIENCY RESULTING
FROM GASTRECTOMY, SOME MALABSORPTION SYNDROMES AND NUTRITIONAL
DEFICIENCIES_ _
1,000 microgram every two or three months.
TOBACCO AMBLYOPIA AND LEBER'S OPTIC ATROPHY_ _
_INITIALLY_:
1,000 microgram daily by intramuscular injection for two weeks then
twice weekly
for four weeks.
_MAINTENANCE_:
1,000 microgram monthly.
4.3 CONTRAINDICATIONS
Known sensitivity to hydroxocobalamin or an