Pfizer (Australia) SODIUM BICARBONATE 8.4% (8.4 g/100 mL) injection BP vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium bicarbonate, Quantity: 8.4 g

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: disodium edetate; water for injections

Administration route:

Intravenous

Units in package:

100mL x 10

Class:

Medicine Registered

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

1. Metabolic acidosis in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis where a rapid increase in plasma total CO2 content is crucial. Treatment of metabolic acidosis should be concurrent with measures designed to control the cause of the acidosis. 2.Urinary alkalinisation in the treatment of certain drug intoxications (ie barbiturates, salicylates, lithium, methyl alcohol) and in the haemolytic reactions requiring alkalinisation of the urine to diminish nephrotoxicity of blood pigments. Urinary alkalinisation is also used in methotrexate therapy to prevent nephrotoxicity. 3.Severe diarrhoea which is often accompanied by a significant loss of bicarbonate.

Product summary:

Visual Identification: Clear, colourless solution, free from visible impurities; Container Type: Vial; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-07-09

Patient Information leaflet

SODIUM
BICARBONATE
_INTRAVENOUS INFUSION_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sodium Bicarbonate
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 benefits and
risks. Your doctor has weighed the
risks of you being given Sodium
Bicarbonate Intravenous Infusion
against the benefits they expect it to
have for you.
This medicine is likely to be used
while you are at the clinic or in
hospital. If possible, please read this
leaflet carefully before this medicine
is given to you. In some cases this
leaflet may be given to you after the
medicine has been used.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT SODIUM
BICARBONATE
INTRAVENOUS
INFUSION IS USED FOR
Sodium Bicarbonate Intravenous
Infusion is given to patients who
have too much acid, or who have not
enough sodium or bicarbonate in
their blood. This chemical is
naturally present in body fluids and is
needed for normal body function.
Sodium Bicarbonate Intravenous
Infusion may be used for the
treatment of other conditions that are
not mentioned above. Your doctor
will be able to tell you about the
specific condition for which you
have been given Sodium Bicarbonate
Intravenous Infusion.
Ask your doctor if you have any
questions about why it has been
given to you.
BEFORE YOU ARE TREATED
WITH SODIUM
BICARBONATE
INTRAVENOUS
INFUSION
_WHEN YOU MUST NOT TAKE IT_
YOU SHOULD NOT BE GIVEN SODIUM
BICARBONATE INTRAVENOUS INFUSION
IF YOU HAVE AN ALLERGY TO:
•
any medicine containing sodium
bicarbonate
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction 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.
SODIUM BICARBONATE INTRAVENOU

Summary of Product characteristics

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Page 1 of 9
AUSTRALIAN
PRODUCT
INFORMATION
–
SODIUM
BICARBONATE
8.4%
(SODIUM
BICARBONATE) INJECTION BP
1.
NAME OF THE MEDICINE
Sodium bicarbonate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
A sterile, hypertonic, preservative-free solution containing sodium
bicarbonate 8.4 g/100 mL.
Each mL of solution contains 1 mmol each of sodium and bicarbonate
ions.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Injection for intravenous infusion.
A clear, colourless solution, free from visible impurities.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
METABOLIC ACIDOSIS
in severe renal disease, uncontrolled diabetes, circulatory
insufficiency due
to shock or severe dehydration, extracorporeal circulation of blood,
cardiac arrest and severe
primary lactic acidosis where a rapid increase in plasma total CO
2
content is crucial. Treatment
of metabolic acidosis should be concurrent with measures designed to
control the cause of the
acidosis.
URINARY ALKALINISATION
in the treatment of certain drug intoxications (i.e. barbiturates,
salicylates, lithium, methyl alcohol) and in the haemolytic reactions
requiring alkalinisation of
the urine to diminish nephrotoxicity of blood pigments.
Urinary alkalinisation is also used in methotrexate therapy to prevent
nephrotoxicity.
SEVERE DIARRHOEA
which is often accompanied by a significant loss of bicarbonate.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
_IN CARDIAC ARREST _
Administration is determined based on the results of arterial blood
pH, PaCO
2
and calculation
of base deficit. For adults, an initial dose of 1 mmol/kg followed by
0.5 mmol/kg every
10 minutes of arrest, depending on arterial blood gases. In cardiac
arrest, the risks from
acidosis exceed those of hypernatraemia.
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Supersedes: pfpsodbi10320
Page 2 of 9
_IN MILD CONDITIONS OF METABOLIC ACIDOSIS _
Sodium Bicarbonate Intravenous Infusion may be admixed with other
intravenous fluids if
compatibility is pr