Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
sodium chloride, Quantity: 9 g/L
Fresenius Kabi Australia Pty Ltd
Sodium chloride
Injection, intravenous infusion
Excipient Ingredients: water for injections; sodium hydroxide; hydrochloric acid
Intravenous
40 x 250mL Freeflex bags, 20 x 250mL Freeflex bags, 30 x 250mL Freeflex bags, 35 x 250mL Freeflex bags
Not scheduled. Not considered by committee
Normal saline can be used as a vehicle for many parenteral drugs and as an electrolyte replenisher for maintenance or replacement of deficits of extracellular fluid. It can also be used as a sterile irrigation medium.
Visual Identification: clear, colourless liquid; Container Type: Bag; Container Material: Composite plastic laminate; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2008-12-08
Sodium Chloride Injection 1 SODIUM CHLORIDE 0.9% INJECTION CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING SODIUM CHLORIDE 0.9% INJECTION? Sodium chloride 0.9% contains the active ingredient sodium chloride. Sodium For more information, see Section 1. Why am I using Sodium Chloride 0.9% Injection? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE SODIUM CHLORIDE 0.9% INJECTION? Do not use if you have ever had an allergic reaction to Sodium Chloride 0.9% or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Sodium Chloride 0.9% Injection? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Sodium Chloride 0.9% and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE SODIUM CHLORIDE 0.9% INJECTION? • Sodium Chloride 0.9% Injection will be given to you by your doctor or specially trained nurse by infusion or drip into the vein. They will decide what dose and how long you will receive it for. This depends on your medical condition and other factors. • More instructions can be found in Section 4. How do I use Sodium Chloride 0.9% Injection? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING SODIUM CHLORIDE 0.9% INJECTION? THINGS YOU SHOULD DO • If you become pregnant while being given Sodium Chloride 0.9% tell your doctor immediately. • Remind any doctor, dentist or pharmacist or nurse you visit that you have been given using Sodium Chloride 0.9% Injection. • Before surgery, tell the surgeon or anaesthetist that you have been given this medicine. DRIVING OR USING MACHINES • Be careful driving or operating machinery until you Aqra d-dokument sħiħ
1 AUSTRALIAN PRODUCT INFORMATION – SODIUM CHLORIDE 0.9 % FREEFLEX (SODIUM CHLORIDE) 1 NAME OF THE MEDICINE Sodium chloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sterile isotonic solution of sodium chloride 9 g/L in Water for Injections, containing no preservatives (normal saline). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Solution for Injection. Clear, colourless liquid 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Normal saline can be used as the vehicle for many parenteral drugs and as an electrolyte replenisher for maintenance or replacement of deficits of extracellular fluid. It can also be used as a sterile irrigation medium. 4.2 Dose and method of administration The dosage of sodium chloride as a vehicle for parenteral drugs and as an electrolyte replenisher must be calculated after consideration of clinical and laboratory data. For use in one patient, on one occasion only. It does not contain antimicrobials. Any unused portion should be discarded. Care should be taken with intravenous technique to avoid injection site reactions and infections. 4.3 Contraindications Sodium Chloride 0.9 % is contraindicated in patients with congestive heart failure, severe renal impairment, conditions of sodium retention and oedema, liver cirrhosis and irrigation during electrosurgical procedures. 4.4 Special warnings and precautions for use Do not use unless the solution is clear. The entire contents of the bag should be used promptly. 2 When used as a vehicle for intravenous drug delivery, the product information document of such drugs should be checked prior to use to ensure compatibility with the sodium chloride solution. Reconstitution instructions should be read carefully. Excessive administration of sodium chloride causes hypernatraemia, resulting in dehydration of internal organs, hypokalaemia and acidosis. Monitoring of fluid, electrolyte and acid/base balance may be necessary. Congestive heart failure and pulmonary oedema may be precipitated, particularly Aqra d-dokument sħiħ