Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
sodium chloride, Quantity: 9 mg/mL
Phebra Pty Ltd
Injection, solution
Excipient Ingredients: water for injections; hydrochloric acid; sodium hydroxide
Subcutaneous, Intramuscular, Intravenous
100mL x 10
Not scheduled. Not considered by committee
INDICATIONS AS AT 01 JAN 1991 : Prophylaxis of heat prostration or muscle cramps, chloride deficiency due to diuresis or salt restriction, prevention or treatment of extracellular volume depletion. Parenteral - 0.9% (Isotonic) NaCl is used to restore sodium and chloride losses; to dilute or dissolve drugs for IV, IM or SC use, flushing of IV catheters; extracellular fluid replacement; priming solution for hemodialysis; initiate and terminate blood transfusions so red blood cells will not hemolyze; metabolic alkalosis when there is fluid loss and mild sodium depletion. Topical or irrigation - relief of inflamed, dry or crusted nasal membranes or as a topical irrigating or flush solution.
Visual Identification: Clear, colourless solution, practically free from visible particles.; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
1994-05-23
Sodium Chloride 0.9% solution for injection V03 1 SODIUM CHLORIDE 0.9% SOLUTION FOR 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%? Sodium Chloride 0.9% contains the active ingredient sodium chloride. Sodium Chloride 0.9% is used to replace lost body fluids and salts, dilute other medicines, and/or act as a sterile liquid for washing wounds, nasal passages or during surgery. For more information, see Section 1. Why am I using Sodium Chloride 0.9%? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE SODIUM CHLORIDE 0.9%? 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%? 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%? • Sodium Chloride Injection 0.9% must only give by a doctor or healthcare professional. 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%? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING SODIUM CHLORIDE 0.9%? THINGS YOU SHOULD DO • If you become pregnant while being given Sodium Chloride 0.9%, tell your doctor immediately. • Remind any doctor, dentist, pharmacist or nurse you visit that you have been given Sodium Chloride 0.9%. • Before surgery, tell the surgeon or anaesthetist that you have been given this medicine. DRIVING OR Lue koko asiakirja
PRODUCT INFORMATION Australian Product Information - Sodium Chloride 0.9% Solution for Injection Page 1 of 7 Version 04 SODIUM CHLORIDE 0.9% (SODIUM CHLORIDE) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Sodium chloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains 9 mg sodium chloride equivalent to 0.15 mmol sodium ions and 0.15 mmol chloride ions. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Sodium Chloride 0.9% is an isotonic solution for injection. pH 4.5 to 8.0 . Osmolality of 296 mOsm/L. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Prophylaxis of heat prostration or muscle cramps, chloride deficiency due to diuresis or salt restriction, prevention or treatment of extracellular volume depletion. PARENTERAL Sodium Chloride 0.9% (isotonic) is used to restore sodium chloride losses; to dilute or dissolve drugs for intravenous (IV), intramuscular (IM), or subcutaneous (SC) use; flushing of IV catheters; extracellular fluid replacement; priming solution for haemodialysis; initiate and terminate blood transfusions so red blood cells will not haemolyse; metabolic alkalosis when there is fluid loss and mild sodium depletion. TOPICAL OR IRRIGATION Relief of inflamed, dry, or crusted nasal membranes or as a topical irrigating or flush solution. 4.2 D OSE 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. Use in one patient on one occasion only and discard. Contains no antimicrobial preservative. Solutions containing visible, solid particles must not be used. 4.3 C ONTRAINDICATIONS • Congestive heart failure • Severe renal impairment • Conditions of sodium retention and oedema PRODUCT INFORMATION SODIUM CHLORIDE 0.9% SOLUTION FOR INJECTION Australian Product Information - Sodium Chloride 0.9% Solution for Injection Page 2 of 7 Version 04 • Liver cirrhosis • Irrigation during electrosurgical proced Lue koko asiakirja