HYDROXO-B12 hydroxocobalamin chloride 1mg/1mL injection ampoule

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

hydroxocobalamin chloride, Quantity: 1 mg/mL

Tilgjengelig fra:

Aspen Pharmacare Australia Pty Ltd

INN (International Name):

Hydroxocobalamin chloride

Legemiddelform:

Injection, solution

Sammensetning:

Excipient Ingredients: water for injections; sodium chloride

Administreringsrute:

Intramuscular

Enheter i pakken:

3

Resept typen:

Not scheduled. Not considered by committee

Indikasjoner:

Prophylaxis and treatment of pernicious (Addisonian) anaemia and other macrocytic anaemias associated with vitaminB12 deficiency. Treatment of optic neuropathies such as tobacco amblyopia and Leber's optic atrophy.

Produkt oppsummering:

Visual Identification: clear dark red solution; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

2010-07-22

Informasjon til brukeren

HYDROXO-B12
INJECTION
_Hydroxocobalamin (hye-drox-oh-koe-BAL-a-min)_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about HYDROXO-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 this medicine against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN IT, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT HYDROXO-B12
INJECTION IS USED FOR
HYDROXO-B12 Injection contains
hydroxocobalamin as the active
ingredient which is a form of vitamin
B12.
It 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY HYDROXO-
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 IT
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN
HYDROXO-B12 INJECTION IF YOU
HAVE AN ALLERGY TO:
•
hydroxocobalamin
•
cobalt
•
any of the ingredients listed at the
end of this leaflet.
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 IT 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_
TELL Y

Preparatomtale

HYDROXO-B12 – Product Information
Page 1 of 7
AUSTRALIAN PRODUCT INFORMATION - HYDROXO-B12
(HYDROXOCOBALAMIN CHLORIDE)
1. NAME OF MEDICINE
Hydroxocobalamin chloride (vitamin B
12
)
2. & 3. QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Hydroxocobalamin is a dark red, odourless crystalline powder or
crystals. It is soluble
in water and alcohol, sparingly soluble in methyl alcohol and
practically insoluble in
acetone, chloroform and ether.
Hydroxocobalamin (as chloride) and hydroxocobalmin chloride 1.027
mg/mL
equivalent to 1.0 mg/mL hydroxocobalmin.
HYDROXO-B12 also contains sodium chloride 9.0 mg and hydrochloric acid
for pH
adjustment and water for injections. The pH of the solution is
approximately 4.6.
Solution for injection in ampoules, 1mg/mL (1000 microgram/mL) (clear
dark red
solution) in a pack of 3 ampoules.
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. Hydroxo-B12 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.
_ _
_INITIALLY._ 1,000 micrograms on alternate days for one to two weeks.
_MAINTENANCE._ 1,000 micrograms every two months.
HYDROXO-B12 – Product Information
Page 2 of 7
PROPHYLAXIS OF MACROCYTIC ANAEMIA ASSOCIATED WITH VITAMIN B12
DEFICIENCY
RESULTING