BIOLOGICAL THERAPIES SODIUM ASCORBATE SOLUTION 30g/100mL injection bag

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium ascorbate, Quantity: 300 g/L

Available from:

Orthomolecular Medisearch Laboratories Pty Ltd Trading As Biological Therapies

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: water for injections

Administration route:

Intravenous

Units in package:

1x30g/100mL

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Sodium ascorbate solution injection for intravenous infusion is indicated for the treatment of vitamin C deficiency when oral treatment is not feasible.

Product summary:

Visual Identification: Clear, colourless (or nearly so) solution; Container Type: Bag; Container Material: PVC; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

1994-01-31

Patient Information leaflet

BIOLOGICAL THERAPIES SODIUM ASCORBATE SOLUTION
INJECTION FOR INTRAVENOUS INFUSION 30 G IN 100 ML, 15 G IN 100ML,
15 G IN 50 ML, 45 G IN 500 ML
_ _
CONSUMER MEDICINE INFORMATION
_Australian Consumer Medicine Information – Biological Therapies
Sodium Ascorbate Solution Injection for Intravenous Infusion-
cmiIVC1809 _
_page 1 of 3 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sodium Ascorbate Solution
Injection for Intravenous Infusion.
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 giving
Sodium Ascorbate Solution Injection against
the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING
GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET. You may need to read it
again.
WHAT SODIUM ASCORBATE SOLUTION
INJECTION IS USED FOR
Sodium Ascorbate Solution Injection contains
the active ingredient sodium ascorbate
(Vitamin C).
Sodium Ascorbate Solution Injection may be
prescribed if you have a diagnosed Vitamin C
deficiency and are unable to absorb sufficient
Vitamin C when taking it by mouth.
Your doctor may have prescribed Sodium
Ascorbate Solution Injection for another
reason. Ask your doctor if you have any
questions about why Sodium Ascorbate
Solution Injection has been prescribed for
you.
SODIUM ASCORBATE SOLUTION INJECTION IS
NOT ADDICTIVE.
BEFORE YOU HAVE SODIUM
ASCORBATE SOLUTION INJECTION
_WHEN YOU MUST NOT USE IT: _
DO NOT HAVE SODIUM ASCORBATE SOLUTION
INJECTION GIVEN IF:
•
YOU HAVE A KNOWN ALLERGY TO
VITAMIN C
If you have had an allergic reaction to
vitamin C before, you may be allergic to
Sodium Ascorbate Solution Injection.
•
YOU HAVE KIDNEY DISEASE OR
KIDNEY STONES
There have been a few cases where
injected vitamin C has made kidney
disease worse.
•
THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING
•
THE EXPIRY DATE (EXP.) PRINTED ON
THE PACK HAS PASSED
If you have this medicine af

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
BIOLOGICAL THERAPIES SODIUM ASCORBATE SOLUTION
INJECTION FOR INTRAVENOUS INFUSION 30 G IN 100 ML, 15 G IN 50 ML, 15 G
IN 100 ML, 45 G IN 500 ML
_Biological Therapies Product Information – Sodium Ascorbate
Solution Injections for Intravenous Infusion - _
_IVCpiM1809 _
page 1 of 3
_ _
AUST R 47757, 47750, 22283, 22254, 22282,
22284, 22286
1. NAME OF THE MEDICINE
Sodium ascorbate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Biological Therapies Sodium Ascorbate Injection for
Intravenous Infusion contains sodium ascorbate and water for
injections.
All of the Sodium Ascorbate Solution Injections mentioned in
this product information sheet are hypertonic and single use.
The pack sizes for these products are as described below.
INGREDIENTS PER ML:
PRODUCT
SODIUM
ASCORBATE
WATER FOR
INJECTIONS
30 g in 100 mL
300 mg/mL
qs.
15 g in 50 mL
300 mg/mL
qs.
15 g in 100 mL
150 mg/mL
qs.
45 g in 500 mL
90 mg/mL
qs.
SUMMARY INFORMATION:
_SODIUM ASCORBATE SOLUTION 30 G IN 100 ML (300 MG/ML) _
AUST R 47757 (vial) & AUST R 47750 (bag)_ _
OSMOLALITY
SODIUM/ML
ASCORBATE/ML
MOSM/KG
MG
MMOL
MEQ
MG
MMOL
MEQ
2366
34.8
1.50
1.50
265.2
1.50
1.50
_SODIUM ASCORBATE SOLUTION 15 G IN 50 ML (300 MG/ML) _
AUST R 22283 (vial) & AUST R 22254 (bag)
OSMOLALITY
SODIUM/ML
ASCORBATE/ML
MOSM/KG
MG
MMOL
MEQ
MG
MMOL
MEQ
2366
34.8
1.50
1.50
265.2
1.50
1.50
_SODIUM ASCORBATE SOLUTION 15 G IN 100 ML (150 MG/ML) _
AUST R 22282 (vial) & AUST R 22284 (bag)
OSMOLALITY
SODIUM/ML
ASCORBATE/ML
MOSM/KG
MG
MMOL
MEQ
MG
MMOL
MEQ
1268
17.4
0.75
0.75
132.6
0.75
0.75
_SODIUM ASCORBATE SOLUTION 45 G IN 500 ML (90 MG/ML) _
AUST R 22286 (bag)
OSMOLALITY
SODIUM/ML
ASCORBATE/ML
MOSM/KG
MG
MMOL
MEQ
MG
MMOL
MEQ
782
10.44
0.45
0.45
79.56
0.45
0.45
Sodium ascorbate is a white, or very slightly yellow crystalline
powder which is odourless and has a slightly salty taste. It is
freely soluble in water (1 g is soluble in 3 mL water) and
dissolves to give a clear, colourless or slightly yellow solution.
3. PHARMACEUTICAL FORM
Biological Therapies
Sodiu