BIOLOGICAL THERAPIES CYANOCOBALAMIN cyanocobalamin 20 mg in 2 mL injection vial

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

cyanocobalamin, Quantity: 10 mg/mL

Disponible des:

Orthomolecular Medisearch Laboratories Pty Ltd Trading As Biological Therapies

formulario farmacéutico:

Injection, solution

Composición:

Excipient Ingredients: sodium chloride; water for injections; hydrochloric acid

Vía de administración:

Intramuscular

Unidades en paquete:

2mL X 1, 2mL X 6

tipo de receta:

Not scheduled. Not considered by committee

indicaciones terapéuticas:

Cobalamin deficiency may exist that is unable to be corrected by oral intake and in these cases parenteral administration may be preferable. Oral administration of vitamin B12 may be insufficient in pernicious anaemia, malabsorption disorders, gastrectomy and gastrointestinal pathologies. Specific indications may include: 1. Pernicious anaemia as a result of in situ B12 deficiency.

Resumen del producto:

Visual Identification: Clear red liquid; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Estat d'Autorització:

Registered

Data d'autorització:

1991-10-08

Informació per a l'usuari

BIOLOGICAL THERAPIES CYANOCOBALAMIN 20 MG IN 2 ML INJECTION
VITAMIN B 12 FOR INTRAMUSCULAR INJECTION
_CONSUMER MEDICINE INFORMATION _
_Biological Therapies _
_CMI – Cyanocobalamin 20 mg in 2 mL Injection – cmi17s1811 _
_page 1 of 2 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions
about Cyanocobalamin 20 mg in 2 mL
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 has weighed the risks of administering
Cyanocobalamin Injection against the
benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT THE
ADMINISTRATION OF THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You
may need to read it again.
WHAT CYANOCOBALAMIN INJECTION IS
USED FOR
Cyanocobalamin 20 mg in 2 mL Injection
contains the active ingredient
Cyanocobalamin (Vitamin B12).
Cyanocobalamin belongs to a group of
vitamins called cobalamins. The cobalamins
are various different forms of Vitamin B12.
Pernicious anaemia:
Anaemia occurs when red blood cells cannot
carry sufficient oxygen to meet the
requirements of the body’s cells. This may
be due to a deficiency of oxygen, lack of
ability of red blood cells to bind oxygen, or
some defect of red blood cells. Vitamin B12
is needed to make red blood cells grow
correctly, without it the red blood cells
become large and less effective. This is a
type of anaemia called megaloblastic (large
cells) anaemia. Megaloblastic anaemia may
also be caused by a folate (folic acid)
deficiency. The “pernicious” part is because
prolonged Vitamin B12 deficit can also lead to
damage to the nervous system. The
combination of nervous system damage and
anaemia is called Pernicious Anaemia.
Symptoms of pernicious anaemia include
tiredness, breathlessness, lack of energy and
different sensations of the nervous system,
such as pins and needles and loss of
strength.
Cyanocobalamin may be prescribed to help
with the symptoms of pe

Fitxa tècnica

AUSTRALIAN PRODUCT INFORMATION
BIOLOGICAL THERAPIES CYANOCOBALAMIN 20 MG IN 2 ML INJECTION
Biological Therapies page 1 of 6 Version ID: pi17s1810
AUST R: 22407
1. NAME OF THE MEDICINE
Cyanocobalamin
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Biological Therapies Cyanocobalamin 20 mg in 2 mL Injection vial
contains a minimum of 2 mL of solution and has cyanocobalamin
20 mg as an active ingredient. Each 1 mL contains cyanocobalamin 10
mg, sodium chloride 9 mg, hydrochloric acid for pH
adjustment and water for injections.
3. PHARMACEUTICAL FORM
Biological Therapies Cyanocobalamin 20 mg in 2 mL Injection is a clear
red coloured solution for injection supplied in amber glass
vials. The pH of the solution is 3.8-5.5.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cobalamin deficiency may exist that is unable to be corrected by oral
intake and in these cases parenteral administration may be
preferable. Oral administration of vitamin B
12
may be insufficient in pernicious anaemia, malabsorption disorders,
gastrectomy and
gastrointestinal pathologies.
Biological Therapies Cyanocobalamin 20 mg in 2 mL Injection is
indicated for pernicious anaemia as a result of _in situ_ B
12
deficiency.
4.2 DOSE AND METHOD OF ADMINISTRATION
WARNINGS:
A sensitivity history should be obtained from the patient prior to
administration of vitamin B
12.
An intradermal test dose is
recommended before vitamin B
12
is administered to patients who may be sensitive to cobalamins.
Anaphylactic shock and death have been reported after parenteral
vitamin B
12
administration. Should anaphylactic shock occur,
immediately stop administration of the product and administer the
appropriate dose of adrenalin 1:1000 (1 mg/1 mL) intramuscularly.
This may be repeated at five minute intervals, if clinically
indicated. Additionally, intravenous administration of corticosteroids
and
antihistamines may be considered.
Diagnosis of vitamin B
12
deficiency should be confirmed by laboratory investigation before
institution of vitamin B
12
therapy. Do not
use vitam