国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
calcium chloride dihydrate, Quantity: 67.5 mg; sodium chloride, Quantity: 1.5 g; sodium lactate, Quantity: 792.5 mg; potassium chloride, Quantity: 100 mg
Fresenius Kabi Australia Pty Ltd
calcium chloride dihydrate,potassium chloride,sodium chloride,sodium lactate
Injection, solution
Excipient Ingredients: water for injections; hydrochloric acid; sodium hydroxide
Intravenous
20 bags, 35 bags, 30 bags, 40 bags
Not scheduled. Not considered by committee
Compound Sodium Lactate (Hartmann's Solution) is used:,? for intravenous fluid and electrolyte replacement,? as a source of bicarbonate in the treatment of mild to moderate metabolic acidosis associated with dehydration or associated with potassium deficiency,? as a vehicle for intravenous drug delivery, if the drugs are compatible with the solutions.
Visual Identification: Clear colourless solution; Container Type: Bag; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2009-03-12
CMI FOR COMPOUND SODIUM LACTATE (HARTMANN’S) JUL 2018 1 COMPOUND SODIUM LACTATE (HARTMANN’S) SOLUTION FOR INJECTION CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about Compound Sodium Lactate (Hartmann’s). It does not contain all the information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you being given Compound Sodium Lactate (Hartmann’s) against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT COMPOUND SODIUM LACTATE (HARTMANN’S) IS USED FOR Compound Sodium Lactate (Hartmann’s) is used to replace body fluid and mineral salts that may be lost for a variety of medical reasons. It is especially suitable when the losses result in too much acid being present in the blood. YOUR DOCTOR MAY HAVE PRESCRIBED IT FOR ANOTHER REASON. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. BEFORE YOU ARE GIVEN COMPOUND SODIUM LACTATE (HARTMANN’S) _WHEN YOU SHOULD NOT BE GIVEN _ _IT _ COMPOUND SODIUM LACTATE (HARTMANN’S) SHOULD NOT BE GIVEN; You have congestive heart failure (constant wheezing, shortness of breath); you have severely reduced kidney function; you have too much sodium and chloride in your blood that is not being corrected with medication; it is intended to be administered at the same time and through the same injection equipment as blood preparations (citrate anticoagulated/preserved blood) or ceftriaxone, an antibiotic (if a baby < 1 month of age is to be treated, administration at the same time as ceftriaxone must never occur) the expiry date printed on the pack on the bottom of the bag has passed, or if the packaging is torn or shows any signs of tampering. For use in one patient on one occasion only. It may have no effect at all, or worse 完全なドキュメントを読む
AUSTRALIAN PRODUCT INFORMATION- COMPOUND SODIUM LACTATE (HARTMANN'S SOLUTION) 1 NAME OF MEDICINE Calcium chloride dihydrate, potassium chloride, sodium chloride and sodium lactate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Compound Sodium Lactate (Hartmann’s) contains Sodium Lactate (3.17 g/L), Sodium Chloride (6.0 g/L), Potassium Chloride (400 mg/L) and Calcium Chloride Dihydrate (270 mg/L). The total amount of electrolytes per litre are: sodium 131 mmol, potassium 5 mmol, chloride 112 mmol, calcium 2 mmol, bicarbonate (as lactate) 28 mmol. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Injection for intravenous infusion. The osmolality is approximately 255 mOsm/kg water. The solution is isotonic, sterile, non- pyrogenic and does not contain antimicrobial agent or added buffers. The pH range is 5.0 to 7.0. Compound Sodium Lactate (Hartmann's) Solution for Injection is also known as Ringer’s Lactate. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Compound Sodium Lactate (Hartmann's) is used: • for intravenous fluid and electrolyte replacement • as a source of bicarbonate in the treatment of mild to moderate metabolic acidosis associated with dehydration or associated with potassium deficiency • as a vehicle for intravenous drug delivery, if the drugs are compatible with the solutions. 4.2 DOSE AND METHOD OF ADMINISTRATION To be used as directed by the doctor. The dosage of Compound Sodium Lactate (Hartmann’s) is dependent upon the age, weight and clinical conditions of the patient as well as laboratory determinations. Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration. Contains no antimicrobials. For use in one patient on one occasion only. Discard any unused portion. Care should be taken with intravenous administration technique to avoid administration site reactions and infection. Do not administer Compound Sodium Lactate (Hartmann’s) unless the solution is clear and the seals are 完全なドキュメントを読む