Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
sodium bicarbonate, Quantity: 84 mg/mL
Phebra Pty Ltd
sodium bicarbonate
Injection, solution
Excipient Ingredients: disodium edetate; water for injections
Intravenous
10mL vial, 10 per pack
Not scheduled. Not considered by committee
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.
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
Licence status A
2007-02-02
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 Read the complete document
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 Read the complete document