BIOLOGICAL THERAPIES IV B-DOSE 2mL injection vial

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

thiamine hydrochloride, Quantity: 5 mg/mL; riboflavine sodium phosphate, Quantity: 2.5 mg/mL; nicotinamide, Quantity: 50 mg/mL; dexpanthenol, Quantity: 10 mg/mL; pyridoxine hydrochloride, Quantity: 25 mg/mL

Prieinama:

Orthomolecular Medisearch Laboratories Pty Ltd Trading As Biological Therapies

INN (Tarptautinis Pavadinimas):

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

Vaisto forma:

Injection, solution

Sudėtis:

Excipient Ingredients: disodium edetate; water for injections

Vartojimo būdas:

Intravenous

Vienetai pakuotėje:

2mL X 6, 2mL X 1

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

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. Patients requiring parenteral B vitamin therapy who cannot tolerate intramuscular injections. 5. Recovery from Beriberi and Wernicke's syndrome as a result of Vitamin B1 deficiency. Please note that IV B-Dose 2mL Injection does not contain sufficient thiamine for acute treatment of Wernicke's syndrome. 6. Pellagra as a result of Vitamin B3 deficiency. Patients with pellagra may have a concurrent deficiency of B1, B2 and B6. 7. Peripheral neuritis caused by vari

Produkto santrauka:

Visual Identification: Clear, yellow solution; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 1 Years; Container Temperature: Store below 25 degrees Celsius

Autorizacija statusas:

Registered

Leidimo data:

1991-10-08

Pakuotės lapelis

BIOLOGICAL THERAPIES IV B-DOSE 2 ML INJECTION
_VITAMIN B COMPLEX FOR INTRAVENOUS INJECTION _
CONSUMER MEDICINE INFORMATION
_Biological Therapies IV B-Dose 2 mL Injection Version IDcmi18s1911 _
_page 1 of 3 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions
about Biological Therapies IV 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
IV 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 IV B-
DOSE INJECTION IS USED FOR
IV B-Dose 2 mL Injection contains the
Vitamins B1, B2, B3, B5 and B6 as the
following active ingredients:
B1 - Thiamine hydrochloride,
B2 - Riboflavine sodium phosphate,
B3 - Nicotinamide,
B5 - Dexpanthenol,
B6 - Pyridoxine hydrochloride.
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 Injection is appropriate
for patients who may not tolerate higher
doses of the B vitamins and/or for patients
that may not like intramuscular injections.
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.
Some of the B vitamins need other B vi

Prekės savybės

AUSTRALIAN PRODUCT INFORMATION
BIOLOGICAL THERAPIES IV B-DOSE 2 ML INJECTION
(THIAMINE HYDROCHLORIDE, RIBOFLAVINE SODIUM PHOSPHATE, NICOTINAMIDE,
DEXPANTHENOL, PYRIDOXINE HYDROCHLORIDE)
Biological Therapies Page 1 of 7
Product Information: BGP4- pi18s1909
AUST R 22429
1
NAME OF THE MEDICINE
Thiamine hydrochloride
Riboflavine sodium phosphate
Nicotinamide
Dexpanthenol
Pyridoxine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Biological Therapies IV B-Dose 2 mL Injection is a B complex mixture
of B1, B2, B3, B5 and B6.
Each vial contains a minimum of 2 mL of solution.
2 mL of this formulation contains:
(B1)
Thiamine hydrochloride 10 mg
(B2)
Riboflavine sodium phosphate 5 mg
(B3)
Nicotinamide 100 mg
(B5)
Dexpanthenol 20 mg
(B6)
Pyridoxine hydrochloride 50 mg
For the full list of excipients, see Section 6.1 List of excipients.
NOTE: Biological Therapies IV B-Dose 2 mL Injection contains no
antimicrobial agent.
3
PHARMACEUTICAL FORM
Biological Therapies IV B-Dose 2 mL Injection solution is a clear,
yellow 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.
Patients requiring parenteral B vitamin therapy who cannot tolerate
intramuscular injections.
5.
Recovery from Beriberi and Wernicke’s syndrome as a result of
Vitamin B1 deficiency. Please note that IV
B-Dose 2mL Injection does not contain sufficient thiamine for acute
treatment of Wernicke’s syndrome.
6.
Pellagra as a result of Vitamin B3 deficiency. Patients with pellagra
may have a concurrent d