Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
sodium bicarbonate, Quantity: 8.4 g
Pfizer Australia Pty Ltd
Injection, intravenous infusion
Excipient Ingredients: disodium edetate; water for injections
Intravenous
100mL x 10
Medicine Registered
Not scheduled. Not considered by committee
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.
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
Registered
1991-07-09
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 Διαβάστε το πλήρες έγγραφο
Version: pfpsodbi10221 Supersedes: pfpsodbi10320 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. Version: pfpsodbi10221 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 Διαβάστε το πλήρες έγγραφο