Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
sodium chloride, Quantity: 9 g/L
Baxter Healthcare Pty Ltd
Injection, intravenous infusion
Excipient Ingredients: water for injections; hydrochloric acid
Intravenous
1x50 mL single bag AHB 1306 and 2x50mL dual bag AHB 1363
Not scheduled. Not considered by committee
INDICATIONS AS AT 9 October 2002: Sodium Chloride (0.9%) Intravenous Infusion is indicated for extracellular fluid replacement and in the management of metabolic alkalosis in the presence of fluid loss, and for restoring or maintaining the concentration of sodium and chloride ions.
Visual Identification: Clear colourless solution; Container Type: Bag; Container Life Time: 18 Months; Container Temperature: Store below 30 degrees Celsius
Registered
1991-09-30
Sodium Chloride CMI Oct 2013 Page 1 of 3 Baxter SODIUM CHLORIDE IV INFUSION _Sodium Chloride Intravenous Infusion BP _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET _ _ This leaflet answers some common questions about Sodium Chloride IV Infusion. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has prescribed Sodium Chloride IV infusion for you in the knowledge that the benefits outweigh any possible risks. If you have any concerns, ask your doctor or pharmacist. KEEP THIS LEAFLET. You may need to read it again. WHAT SODIUM CHLORIDE IV INFUSION IS USED FOR Human body weight is about 60% water, which contains various mineral salts and other elements. Sodium chloride is one of the main mineral salts in the body fluid. An optimum level of salts in circulation is essential for good health. Sodium Chloride IV Infusion is used for treatment of fluid loss and to restore sodium chloride balance. It is used in the treatment of patients who are unable to take fluids and nutrients by mouth. It is also used for dilution of other medicines before injection into the body. BEFORE YOU ARE GIVEN SODIUM CHLORIDE IV INFUSION _SODIUM CHLORIDE IV _ _INFUSION SHOULD NOT BE _ _GIVEN TO YOU IF: _ _ _ • you have congestive heart failure. • you have ischaemic stroke, or • you have severe renal insufficiency Also, the product should not be used if the expiry date printed on the bottom of the bag has passed or if the packaging is torn or shows any signs of tampering. _YOU MUST TELL YOUR _ _DOCTOR IF YOU: _ _ _ • have heart disease • have any other illness, especially the following: kidney disease, liver disease, swelling of the hands, ankles or feet, or breathlessness • are taking any prescription medicine, or even non- prescription medicines • If you are receiving corticosteroids or corticotrophin • have ever had an allergic reaction to sodium chloride injection • are pregnant • are breast Pročitajte cijeli dokument
BAXTER SODIUM CHLORIDE (0.45%, 0.9%, 3%) Intravenous Infusion Version 1.3 1 of 13 AUSTRALIAN PRODUCT INFORMATION – BAXTER 0.45%, 0.9% OR 3% SODIUM CHLORIDE (SODIUM CHLORIDE) INTRAVENOUS INFUSION 1 NAME OF THE MEDICINE Sodium chloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Baxter Sodium Chloride Intravenous (IV) Infusion preparations are sterile, non-pyrogenic solutions of sodium chloride in Water for Injections. The preparations do not contain an antimicrobial agent or added buffer, and have a pH of 4.0 – 7.0. Baxter Sodium Chloride 0.9% IV Infusion is isotonic, Baxter Sodium Chloride 3% IV Infusion is hypertonic and Baxter Sodium Chloride 0.45% IV Infusion is hypotonic as indicated by their osmolarities. The concentration of sodium chloride in each preparation and their osmolarities are shown in Table 1 (see section 6.5 Nature and Contents of Container). For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Solution for Intravenous Infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Baxter Sodium Chloride 0.9% IV Infusion is indicated for extracellular fluid replacement and in the management of metabolic alkalosis in the presence of fluid loss, and for restoring or maintaining the concentration of sodium and chloride ions. • Hypertonic Baxter Sodium Chloride 3% IV Infusion is used in the management of severe sodium chloride depletion when electrolyte restoration is required. • Hypotonic Baxter Sodium Chloride 0.45% IV Infusion is mainly used as a hydrating agent solution. 4.2 DOSE AND METHOD OF ADMINISTRATION GENERAL DIRECTIVE Baxter Sodium Chloride IV Infusion is for intravenous infusion. To be used as directed by the doctor. BAXTER SODIUM CHLORIDE (0.45%, 0.9%, 3%) Intravenous Infusion Version 1.3 2 of 13 Dosage, rate, and duration of administration are to be individualised and depend upon the indication for use, the patient’s age, weight, clinical condition, and concomitant treatment, and on the patient’s clinical and laboratory response to tre Pročitajte cijeli dokument