BIOLOGICAL THERAPIES B-DOSE 2mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

thiamine hydrochloride, Quantity: 10 mg/mL; riboflavine sodium phosphate, Quantity: 2.5 mg/mL; pyridoxine hydrochloride, Quantity: 5 mg/mL; dexpanthenol, Quantity: 2.5 mg/mL; nicotinamide, Quantity: 25 mg/mL; cyanocobalamin, Quantity: 0.5 mg/mL

Available from:

Orthomolecular Medisearch Laboratories Pty Ltd Trading As Biological Therapies

INN (International Name):

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

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections

Administration route:

Intramuscular

Units in package:

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

Prescription type:

(S4) Prescription Only Medicine

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. Commonly, several B vitamin deficiencies may occur similtaneously. 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. Recovery from Beriberi and Wernicke's syndrome as a result of Vitamin B1 deficiency. Please note that B-Dose 2mL Injection does not contain sufficient thiamine for acute treatment of Wernicke's syndrome. 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.

Product summary:

Visual Identification: Clear yellow/brown solution.; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 6 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-08

Patient Information leaflet

BIOLOGICAL THERAPIES B-DOSE 2 ML INJECTION
_VITAMIN B COMPLEX FOR INTRAMUSCULAR INJECTION _
CONSUMER MEDICINE INFORMATION
_Biological Therapies B-Dose 2 mL Injection Version ID: cmi14s1910 _
_page 1 of 3 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Biological Therapies B-Dose
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
B-Dose 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
INJECTION IS USED FOR
B-Dose 2 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.
This particular B-Dose product does not
contain any other additives such as
stabilizers or local anaesthetics.
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.
S

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
BIOLOGICAL THERAPIES B-DOSE 2 ML INJECTION
(THIAMINE HYDROCHLORIDE, RIBOFLAVINE SODIUM PHOSPHATE, NICOTINAMIDE,
DEXPANTHENOL, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN)
Biological Therapies page 1 of 8
Version ID: pi14s1909
AUST R 22266
1
NAME OF THE MEDICINE
Thiamine hydrochloride
Riboflavine sodium phosphate
Nicotinamide
Dexpanthenol
Pyridoxine hydrochloride
Cyanocobalamin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Biological Therapies B-Dose 2 mL Injection is a B complex mixture of
B1, B2, B3, B5, B6 and B12.
Each vial contains a minimum of 2 mL of solution.
2 mL of this formulation contains:
(B1)
Thiamine hydrochloride 20 mg
(B2)
Riboflavine sodium phosphate 5 mg
(B3)
Nicotinamide 50 mg
(B5)
Dexpanthenol 5 mg
(B6)
Pyridoxine hydrochloride 10 mg
(B12)
Cyanocobalamin 1 mg
For the full list of excipients, see Section 6.1 List of excipients.
Biological Therapies B-Dose 2 mL Injection contains no antimicrobial
agent or additives such as stabilisers or
local anaesthetics.
3
PHARMACEUTICAL FORM
Biological Therapies B-Dose 2 mL Injection is a clear and
browny-yellow solution.
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.
Commonly, several B vitamin deficiencies may occur simultaneously.
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.
Recovery from Beriberi and Wernicke’s syndrome as a result of
Vitamin B1 deficiency. Please note that
B-Dose 2 mL Injection does not contain sufficient thiamine for acute
treatment of Wernicke’s syndrome.
5.
Pellagra as a result of Vitamin B3 defic