Sodium Bicarbonate Injection (AFT)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Sodium bicarbonate 8.4%;  ;  

Available from:

AFT Pharmaceuticals Ltd

INN (International Name):

Sodium bicarbonate 8.4%

Dosage:

8.4 %

Pharmaceutical form:

Solution for injection

Composition:

Active: Sodium bicarbonate 8.4%     Excipient: Disodium edetate Sodium hydroxide

Units in package:

Vial, glass, Type I, 10mL, 10 dose units

Class:

General sale

Prescription type:

General sale

Manufactured by:

Kirsch Pharma GmbH

Therapeutic indications:

Sodium bicarbonate is used 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 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) to decrease renal absorption of the drug or to correct acidosis.

Product summary:

Package - Contents - Shelf Life: Vial, glass, Type I, 10mL - 10 dose units - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1983-04-14

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 9
1 SODIUM BICARBONATE INJECTION
Sodium bicarbonate 8.4 % w/v injection BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
The molecular weight of the compound is 84.01 and the CAS registry
number is 144-55-8. The
molecular formula is NaHCO
3
.
3 PHARMACEUTICAL FORM
Sodium Bicarbonate Injection is a sterile solution containing 84 mg/mL
sodium bicarbonate
in water for injections. The pH is approximately 7.0-8.5
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Sodium bicarbonate is used 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 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) to decrease
renal absorption of the
drug or to correct acidosis.
4.2
Dose 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 solution leaks from the
vein in the tissues.
Intramuscular injection is not recommended.
Contains no antimicrobial agent and is for single use in one patient
on one occasion only.
Cardiac Arrest or Severe Metabolic Acidosis
Administration is based on the results of