BIOLOGICAL THERAPIES METHYLCOBALAMIN 10mg/2mL injection vial

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

mecobalamin, Quantity: 5 mg/mL

Prieinama:

Orthomolecular Medisearch Laboratories Pty Ltd Trading As Biological Therapies

Vaisto forma:

Injection, solution

Sudėtis:

Excipient Ingredients: sodium chloride; water for injections

Vartojimo būdas:

Intramuscular

Vienetai pakuotėje:

2mL x 5, 2mL x 3, 2mL X 1, 2mL X 6

Recepto tipas:

Not scheduled. Not considered by committee

Terapinės indikacijos:

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. In pernicious anaemia co-methylcobalamin is disproportionately reduced in relation to other cobalamins. 2. As an adjunct to the treatment of peripheral neuropathies and diabetic polyneuropathy.

Produkto santrauka:

Visual Identification: Clear bright red liquid; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 1 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Autorizacija statusas:

Registered

Leidimo data:

1991-10-08

Pakuotės lapelis

BIOLOGICAL THERAPIES METHYLCOBALAMIN 10 MG IN 2 ML INJECTION
VITAMIN B 12 FOR INTRAMUSCULAR INJECTION_ _
_CONSUMER MEDICINE INFORMATION _
_Biological Therapies _
_ _
_CMI –Methylcobalamin 10 mg in 2 mL Injection – cmi16s1712 _
_page 1 of 2 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions
about Methylcobalamin 10 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
Methylcobalamin 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 METHYLCOBALAMIN INJECTION IS
USED FOR
Methylcobalamin 10 mg in 2 mL Injection
contains the active ingredient mecobalamin
(co-methylcobalamin) (Vitamin B12).
Mecobalamin (co-methylcobalamin) 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.
Methylcobalamin

Prekės savybės

Biological Therapies
page 1 of 7 Version ID: pi16s1912
AUSTRALIAN PRODUCT INFORMATION
BIOLOGICAL THERAPIES METHYLCOBALAMIN 10 MG IN 2 ML INJECTION
(MECOBALAMIN (CO-METHYLCOBALAMIN))
AUST R: 22435
1. NAME OF THE MEDICINE
Mecobalamin (co-methylcobalamin)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains a minimum of 2 mL of solution and has mecobalamin
(co-methylcobalamin) 10 mg as an active ingredient.
3. PHARMACEUTICAL FORM
Biological Therapies Methylcobalamin 10 mg in 2 mL Injection is a
clear bright red coloured solution for injection supplied in amber
glass vials. The pH of the solution is 6.0-8.0.
For the full list of excipients, see Section 6.1 List of Excipients.
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.
Specific indications may include:
1.
Pernicious anaemia as a result of in situ B
12
deficiency. In pernicious anaemia mecobalamin (co-methylcobalamin) is
disproportionately reduced in relation to other cobalamins.
2.
As an adjunct to the treatment of peripheral neuropathies and diabetic
polyneuropathy.
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