BIOLOGICAL THERAPIES B-DOSE FORTE 2.5mL injection vial

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

thiamine hydrochloride, Quantity: 100 mg/mL; riboflavine sodium phosphate, Quantity: 2 mg/mL; nicotinamide, Quantity: 20 mg/mL; dexpanthenol, Quantity: 20 mg/mL; pyridoxine hydrochloride, Quantity: 40 mg/mL; cyanocobalamin, Quantity: 0.4 mg/mL

Disponibbli minn:

Orthomolecular Medisearch Laboratories Pty Ltd Trading As Biological Therapies

INN (Isem Internazzjonali):

Cyanocobalamin,Dexpanthenol,Nicotinamide,pyridoxine hydrochloride,riboflavine sodium phosphate,Thiamine hydrochloride

Għamla farmaċewtika:

Injection, solution

Kompożizzjoni:

Excipient Ingredients: disodium edetate; benzyl alcohol; water for injections

Rotta amministrattiva:

Intramuscular

Unitajiet fil-pakkett:

3 x 2.5mL, 5 x 2.5mL, 1 x 2.5mL, 6 x 2.5mL

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

B vitamin deficiencies may exist that are unable to be corrected by oral intake and in these cases parenteral administration may be preferable. Oral administration of B vitamins may be insufficient in; alcoholism, pernicious anaemia, malabsorption disorders, gastrectomy, gastrointestinal pathologies and debilitated and elderly patients. Specific indications include: 1. Rapid saturation of the B group vitamins. 2. When oral administration is not feasible or appropriate. 3. For alcoholic, debilitated and elderly patients when their diet is inadequate. 4. Beriberi and Wernicke's syndrome as a result of Vitamin B1 deficiency. 5. Pellagra as a result of Vitamin B3 deficiency. Patients with pellagra may have a concurrent deficiency of B1, B2, B6 and B12. 6. Peripheral neuritis caused by various B group deficiencies. 7. Carpal tunnel syndrome. 8. Pernicious anaemia as a result of in situ B12 deficiency. General indications include: 1. Angular stomatitis and glossitis have been shown in some instances to respond to t

Sommarju tal-prodott:

Visual Identification: Amber coloured liquid; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 6 Months; Container Temperature: Store at 2 to 8 degrees Celsius

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

1991-10-08

Fuljett ta 'informazzjoni

BIOLOGICAL THERAPIES B-DOSE FORTE 2.5 ML INJECTION
_VITAMIN B COMPLEX FOR INTRAMUSCULAR INJECTION _
CONSUMER MEDICINE INFORMATION
_Biological Therapies B-Dose Forte 2.5 mL Injection Version ID:
cmi19s1910 _
_page 1 of 3 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions
about Biological Therapies B-Dose Forte 2.5
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
B-Dose Forte 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 BIOLOGICAL THERAPIES B-DOSE
FORTE INJECTION IS USED FOR
B-Dose Forte 2.5 mL Injection contains the
Vitamins B1, B2, B3, B5, B6 and B12 as the
following active ingredients:
B1 - Thiamine hydrochloride,
B2 - Riboflavine sodium phosphate,
B3 - Nicotinamide,
B5 - Dexpanthenol,
B6 - Pyridoxine hydrochloride,
B12 - Cyanocobalamin.
These B vitamins are required by the body for
normal metabolic processes in your cells,
including the production of energy. Different
metabolic processes need several of these B
vitamins at the same time. Deficiencies of
one, some or all of these vitamins in your
cells can have serious consequences for your
health.
Vitamin B deficiencies:
Vitamin B deficiencies may occur as a result
of a diet deficient in B vitamins, malnutrition,
or changes to the gastrointestinal tract which
slow or prevent the absorption of B vitamins
(e.g. abdominal surgery or some diseases of
the gastrointestinal tract).
A specific deficiency of vitamin B1 (thiamine)
may cause the disease beriberi.
A specific deficiency of vitamin B3 (niacin)
may cause the disease pellagra.
A specific deficiency of vitamin B12
(cobalamin) may cause the disease
pernicious anaemia.
Some of the B vitamins need other B vitamins
to work properly.
Your

Karatteristiċi tal-prodott

AUSTRALIAN PRODUCT INFORMATION
BIOLOGICAL THERAPIES B-DOSE FORTE 2.5 ML INJECTION
(THIAMINE HYDROCHLORIDE, RIBOFLAVINE SODIUM PHOSPHATE, NICOTINAMIDE,
DEXPANTHENOL, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN)
Biological Therapies
Page 1 of 8
Version ID: pi19s1909
AUST R 22408
1
NAME OF THE MEDICINE
Thiamine hydrochloride
Riboflavine sodium phosphate
Nicotinamide
Dexpanthenol
Pyridoxine hydrochloride
Cyanocobalamin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Biological Therapies B-Dose Forte 2.5 mL Injection is a B complex
mixture of B1, B2, B3, B5, B6 and B12.
Each vial contains a minimum of 2.5 mL of solution.
2.5 mL of this formulation contains:
(B1)
Thiamine hydrochloride 250 mg
(B2)
Riboflavine sodium phosphate 5 mg
(B3)
Nicotinamide 50 mg
(B5)
Dexpanthenol 50 mg
(B6)
Pyridoxine hydrochloride 100 mg
(B12)
Cyanocobalamin 1 mg
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Biological Therapies B-Dose Forte 2.5 mL Injection is a clear, amber
colour.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
B vitamin deficiencies may exist that are unable to be corrected by
oral intake and in these cases parenteral
administration may be preferable. Oral administration of B vitamins
may be insufficient in: alcoholism, pernicious
anaemia, malabsorption disorders, gastrectomy, gastrointestinal
pathologies and debilitated and elderly patients.
SPECIFIC INDICATIONS INCLUDE:
1.
Rapid saturation of the B group vitamins.
2.
When oral administration is not feasible or appropriate.
3.
For alcoholic, debilitated and elderly patients when their diet is
inadequate.
4.
Beriberi and Wernicke’s syndrome as a result of Vitamin B1
deficiency.
5.
Pellagra as a result of Vitamin B3 deficiency. Patients with pellagra
may have a concurrent deficiency of B1,
B2, B6 and B12.
6.
Peripheral neuritis caused by various B group deficiencies.
7.
Carpal tunnel syndrome.
8.
Pernicious anaemia as a result of in situ B12 deficiency.
GENERAL INDICATIONS INCLUDE:
1.
Angular stomatitis and glossitis have been show