Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
potassium chloride, Quantity: 0.3 g/L; magnesium chloride hexahydrate, Quantity: 0.3 g/L; sodium chloride, Quantity: 6.02 g/L; sodium acetate trihydrate, Quantity: 4.63 g/L
Fresenius Kabi Australia Pty Ltd
magnesium chloride hexahydrate,potassium chloride,sodium chloride,Sodium acetate trihydrate
Injection, intravenous infusion
Excipient Ingredients: sodium hydroxide; water for injections; hydrochloric acid
Intravenous Infusion
500mL x 20 bags
Not scheduled. Not considered by committee
Ionolyte is indicated for:,- mild metabolic acidosis,- as a source of water and electrolytes
Visual Identification: Ionolyte solution for infusion is a clear and colourless solution.; Container Type: Bag; Container Material: Plastic; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2014-05-09
CMI for Ionolyte Mar 2016 Filename: IonCMI210316-clean Page 1 of 3 Change: Address Change + AAN IONOLYTE ® SODIUM CHLORIDE, SODIUM ACETATE TRIHYDRATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE HEXAHYDRATE CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Ionolyte. It does not contain all 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 weighed the risk of you using this product against the benefits they expect it will have for you. PLEASE READ THIS LEAFLET CAREFULLY. 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 IS IONOLYTE USED FOR Ionolyte is a sterile infusion solution used as a source of water and electrolytes (salts). It is also used when there is an acid imbalance in the body. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Ionolyte is not addictive. BEFORE YOU ARE GIVEN IONOLYTE _ _ _WHEN _ _YOU _ _MUST _ _NOT _ _BE _ _GIVEN _ _IONOLYTE _ You must NOT be given this product if: You have too much fluid in your body and you have been told that you have a condition known as hyperhydration You have been told that you have pulmonary edema where too much fluid is in your lungs You have been told that you have a congestive heart failure (a condition in which your heart cannot pump enough blood to other organs of your body) You have severely impaired kidney function You have decreased acidity of the blood caused by a metabolic disorder You have high potassium levels in your blood You are allergic (hypersensitive) to any of the active and inactive ingredients of this product IF YOU ARE NOT SURE WHETHER YOU SHOULD BE GIVEN THIS MEDICINE, TALK TO YOUR DOCTOR. _BEFORE YOU ARE GIVEN IONOLYTE _ Your doctor may need to take special precautions and will decide whether you can receive Ionolyte if: You s Read the complete document
Page 1 of 10 AUSTRALIAN PRODUCT INFORMATION IONOLYTE (SODIUM CHLORIDE, SODIUM ACETATE TRIHYDRATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE HEXAHYDRATE) 1. NAME OF MEDICINE Sodium chloride, sodium acetate trihydrate, potassium chloride and magnesium chloride hexahydrate. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ionolyte solution for infusion is a clear and colourless solution. 1000 mL of Ionolyte solution for infusion contains: Sodium chloride 6.02 g Sodium acetate trihydrate 4.63 g Potassium chloride 0.30 g Magnesium chloride hexahydrate 0.30 g Electrolytes per 1000 mL: Sodium (Na + ) 137 mmol Potassium (K + ) 4 mmol Magnesium (Mg 2+ ) 1.5 mmol Chloride (Cl - ) 110 mmol Acetate (CH 3 COO - ) 34 mmol List of excipients: Sodium hydroxide pH adjustment Hydrochloric acid pH adjustment Water for Injections q.s. to 1000 mL Osmolality: approx. 265 mOsm/kg water Titratable acidity: < 2.5 mmol NaOH/L pH: 6.9 to 7.9 For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Solution for infusion. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ionolyte is indicated for: - mild metabolic acidosis - as a source of water and electrolytes 4.2 DOSE AND METHOD OF ADMINISTRATION As directed by the physician. Dosage and rate of administration is dependent on age, weight and clinical condition of the patient as well as laboratory determinations (including acid-base balance) and the concomitant therapy. Page 2 of 10 Product is for single use in one patient only. Discard any residue. Contains no antimicrobial preservatives. To be used immediately after the bag is opened. Parenteral medicine products should be inspected visually for particulate matter and discolouration prior to the administration whenever solution and container permit. All injections in FREE_flex_ ® bags are intended for intravenous administration using sterile equipment. SPECIAL HANDLING INSTRUCTIONS BEFORE ADMINISTERING THE PRODUCT IN PLASTIC BAGS TO PATIENT, REVIEW THESE DIRECTIONS: FREE_FLEX_ ® IV SOLUTION CONTAINER (1) Read the complete document