Phebra SODIUM BICARBONATE 8.4% w/v 840 mg/10 mL injection BP vial

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

sodium bicarbonate, Quantity: 84 mg/mL

Tilgjengelig fra:

Phebra Pty Ltd

INN (International Name):

sodium bicarbonate

Legemiddelform:

Injection, solution

Sammensetning:

Excipient Ingredients: disodium edetate; water for injections

Administreringsrute:

Intravenous

Enheter i pakken:

10mL vial, 10 per pack

Resept typen:

Not scheduled. Not considered by committee

Indikasjoner:

SODIUM BICARBONATE INJECTION is indicated as an alkalinising agent in the treatment of metabolic acidosis which may occur in many conditions including diabetes, starvation, hepatitis, cardiac arrest, shock, severe dehydration, renal insufficiency, severe diarrhoea, Addison's disease or administration of acidifying salts (e.g. excessive sodium chloride, calcium chloride, ammonium chloride). SODIUM BICARBONATE INJECTION is also used to increase urinary pH in order to increase the solubility of certain weak acids (e.g. cystine, sulphonamides, uric acid) and in the treatment of certain intoxications (e.g. methanol, phenobarbitone, salicylates, lithium) to decrease renal absorption of the drug or to correct acidosis.

Produkt oppsummering:

Visual Identification: Clear, colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

2007-02-02

Informasjon til brukeren

Sodium Bicarbonate 8.4% Injection
1of 3
_Version 04_
_ _
SODIUM BICARBONATE 8.4% INJECTION
CONTAINS 84 MG SODIUM BICARBONATE IN 1 ML WATER FOR INJECTIONS
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sodium Bicarbonate
8.4% Injection.
It does not contain all the available
information. It does not take the place
of talking to your doctor.
All medicines have risks and benefits
.
Your doctor has weighed the risks of
you being given Sodium Bicarbonate
8.4% Injection against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET
You may need to read it again.
WHAT
SODIUM
BICARBONATE 8.4%
INJECTION IS USED FOR
Sodium Bicarbonate 8.4% Injection
reduces the amount of acid in the
blood.
Signs of high acid levels include
headaches, weakness, tiredness, fast
breathing and abnormal heart rate.
High levels of acid in the blood can be
caused by diabetes, hepatitis, heart and
kidney problems, shock, severe
dehydration or diarrhoea, Addison‘s
disease and malnutrition.
Sodium Bicarbonate 8.4% Injection
also reduces the amount of acid in the
urine. It is used to speed up the
removal of certain substances from the
body in the case of some types of
poisoning.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SODIUM
BICARBONATE 8.4% INJECTION HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
_ _
BEFORE YOU ARE GIVEN
SODIUM BICARBONATE
8.4% INJECTION
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU SHOULD NOT BE GIVEN SODIUM
BICARBONATE 8.4% INJECTION 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 8.4%INJECTION
SHOULD NOT BE GIVEN IF YOU HA

Preparatomtale

PRODUCT INFORMATION
Australian Product Information – Sodium Bicarbonate 8.4% Injection
Page 1 of 10
Version 04.1
SODIUM BICARBONATE 8.4%
(SODIUM BICARBONATE)
INJECTION
1
NAME OF THE MEDICINE
Sodium bicarbonate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
8.4 G/100 ML (8.4%) Sodium Bicarbonate Injection contains 8.4 g sodium
bicarbonate in 100 mL water for
injections.
840 MG/10 ML (8.4%) Sodium Bicarbonate Injection contains 0.84 g
sodium bicarbonate in 10 mL water for
injections.
Sodium Bicarbonate Injection is a sterile solution. Each mL of
solution contains 84.0 mg of sodium bicarbonate
which gives 23.0 mg (or 1 mmol or 1 mEq) of sodium and 61.0 mg (or 1
mmol or 1 mEq) of bicarbonate.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Clear, colourless solution for injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Sodium Bicarbonate Injection is indicated as an alkalinising agent in
the treatment of metabolic acidosis which may
occur in many conditions including diabetes, starvation, hepatitis,
cardiac arrest, shock, severe dehydration, renal
insufficiency, severe diarrhoea, Addison's disease or administration
of acidifying salts (e.g. excessive sodium
chloride, calcium chloride, ammonium chloride).
Sodium Bicarbonate Injection is also used to increase urinary pH in
order to increase the solubility of certain weak
acids (e.g. cystine, sulphonamides, uric acid) and in the treatment of
certain intoxications (e.g. methanol,
phenobarbitone, salicylates, lithium) to decrease renal absorption of
the drug or to correct acidosis.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Dosage of Sodium Bicarbonate Injection is determined by the severity
of the acidosis, appropriate laboratory
determinations, and the patient's age, weight and clinical condition.
Sodium Bicarbonate Injection is administered by the intravenous route
preferably via a central line. Extravasation
must be avoided; the solution is hypertonic and irritant to veins
resulting in extensive skin necrosis if the so