DBL SODIUM ACETATE (ANHYDROUS) 1.64g/10mL injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium acetate, Quantity: 0.164 g/mL

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: water for injections

Administration route:

Intravenous

Units in package:

10 x 1.64 g / 10 ml, 50x1.64g/10mL

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Sodium Acetate Concentrated Injection is indicated for inclusion in total parenteral nutrition (TPN) solutions as an electrolyte source. Sodium acetate may also be added to parenteral solution to increase pH. Sodium Acetate Concentrated Injection may be used for the treatment of hyponatraemia (sodium depletion) states, in cases where oral sodium therapy is contraindicated or not tolerated.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-08

Patient Information leaflet

DBL™ SODIUM ACETATE
CONCENTRATED INJECTION
_Sodium acetate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DBL Sodium
Acetate Concentrated 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 or pharmacist
has weighed the risks of you being
given sodium acetate against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
WHAT DBL SODIUM
ACETATE CONCENTRATED
INJECTION IS USED FOR
Sodium acetate can be added to total
parenteral nutrition (TPN) solutions
as a source of sodium and acetate
ions, or to increase the pH of the
solution.
Sodium acetate can also be used to
treat low blood sodium
(hyponatraemia).
Your doctor may have prescribed
sodium acetate for another reason.
Ask your doctor if you have any
questions about why sodium acetate
has been prescribed for you.
DBL Sodium Acetate Concentrated
Injection is not addictive.
BEFORE YOU ARE GIVEN
DBL SODIUM ACETATE
CONCENTRATED
INJECTION
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU SHOULD NOT BE GIVEN DBL
SODIUM ACETATE CONCENTRATED
INJECTION IF YOU HAVE AN ALLERGY TO
SODIUM ACETATE.
Symptoms of an allergic reaction to
sodium acetate may include:
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
YOU SHOULD NOT BE GIVEN DBL
SODIUM ACETATE CONCENTRATED
INJECTION IF YOU HAVE ANY OF THE
FOLLOWING CONDITIONS:
•
high blood sodium
•
fluid retention
•
severe kidney disease
•
severe burns
•
severe or prolonged diarrhoea or
vomiting
•
uncontrolled diabetes mellitus
•
high blood pH
•
low blood calcium
•
low blood chloride
•
low blood potassium.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD BE GIVEN DBL SODIUM
ACETATE CONCENTRATED INJECTION

Summary of Product characteristics

Version: pfpsodai10621
Superscedes: 7.0
Page 1 of 8
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™
SODIUM
ACETATE
CONCENTRATED
INJECTION (SODIUM ACETATE)
1.
NAME OF THE MEDICINE
Sodium acetate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL™ Sodium Acetate Concentrated Injection contains 272.16
milligrams of sodium acetate
(trihydrate) in each mL of water for injections. This is equivalent to
164 milligrams of sodium
acetate (anhydrous) or 46 milligrams of sodium in each mL. DBL™
Sodium
Acetate
Concentrated Injection contains 2 mEq (2 mmol) of sodium ions, and 2
mEq (2 mmol) of
acetate ions in each 1 mL. The strength supplied is 1.64 grams/10 mL
in a glass ampoule.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3.
PHARMACEUTICAL FORM
Sodium acetate trihydrate is a white granular crystalline powder, or
white flakes or colourless
transparent crystals. It is odourless, or has a slight odour of acetic
acid.
DBL™ Sodium Acetate Concentrated Injection is a clear, colourless
solution. The pH of the
solution ranges between 8.2 and 9.2.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DBL™ Sodium Acetate Concentrated Injection is indicated for
inclusion in total parenteral
nutrition (TPN) solutions as an electrolyte source. Sodium acetate may
also be added to
parenteral solutions to increase pH.
DBL™ Sodium Acetate Concentrated Injection may also be used for the
treatment of
hyponatraemia (sodium depletion) states, in cases where oral sodium
therapy is contraindicated
or not tolerated.
4.2
DOSE AND METHOD OF ADMINISTRATION
DBL™ SODIUM ACETATE CONCENTRATED INJECTION MUST BE DILUTED
WITH A SUITABLE INFUSION SOLUTION PRIOR TO ADMINISTRATION.
Each mL of DBL™ Sodium Acetate Concentrated Injection contains 2 mEq
(2 mmol) of
sodium ions and 2 mEq (2 mmol) of acetate ions.
Version: pfpsodai10621
Superscedes: 7.0
Page 2 of 8
1.
USE IN TOTAL PARENTERAL NUTRITION (TPN) SOLUTIONS OR OTHER PARENTERAL
SOLUTIONS
The desired quantity of DBL™ Sodium Acetate Concentrated Injection
should be added
the TP