Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
potassium chloride, Quantity: 2.98 g/L; sodium chloride, Quantity: 9 g/L
Baxter Healthcare Pty Ltd
potassium chloride,sodium chloride
Injection, intravenous infusion
Excipient Ingredients: water for injections; hydrochloric acid
Intravenous
1000 mL bag
Not scheduled. Not considered by committee
The Baxter Potassium Chloride and Sodium Chloride Intravenous Infusion is indicated as a source of water and to restore electrolyte balance as required by the patient's clinical condition, such as hypokalaemia.
Visual Identification: Clear colourless solution; Container Type: Bag; Container Material: PVC; Container Life Time: 12 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2015-09-30
BAXTER POTASSIUM CHLORIDE & SODIUM CHLORIDE Intravenous Infusion 10 mmol/100 mL, 20 mmol/1000 mL, 30 mmol/1000 mL and 40 mmol/1000 mL Version 1.2 1 of 14 AUSTRALIAN PRODUCT INFORMATION – BAXTER POTASSIUM CHLORIDE AND SODIUM CHLORIDE 10 MMOL/100 ML, 20 MMOL/1000 ML, 30 MMOL/1000 ML AND 40 MMOL/1000 ML (POTASSIUM CHLORIDE, SODIUM CHLORIDE) INTRAVENOUS INFUSION 1 NAME OF THE MEDICINE Potassium chloride and sodium chloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Baxter Potassium Chloride and Sodium Chloride Intravenous (IV) Infusion is a sterile, non- pyrogenic solution. The amounts of potassium chloride and sodium chloride dissolved in Water for Injections are shown in Table 1 below. Hydrochloric acid may be added for pH adjustment. They do not contain an antimicrobial agent or added buffer, and have a pH of 4.0 - 7.0. The products are isotonic solutions except for Potassium chloride 30 mmol and 0.9% Sodium chloride and Potassium chloride 40 mmol and 0.9% Sodium chloride, these are hypertonic solutions. TABLE 1: BAXTER POTASSIUM CHLORIDE AND SODIUM CHLORIDE IV INFUSION PREPARATIONS CODE NO* NAME OF THE ACTIVE COMPONENTS & CONCENTRATIONS % (MMOL/CONTAINER) OSMOLARITY Α (MOSMOL/L) ARTG PACK SIZE (ML) AHB6008 Potassium Chloride 0.75% (10) & Sodium Chloride 0.29% (5) 300 (300) 159379 100 x 48 AHB1764 Potassium Chloride 0.15% (20) & Sodium Chloride 0.9% (154) 348 (348) 19466 1000 x 12 AHB1274 Potassium Chloride 0.224% (30) & Sodium Chloride 0.9% (154) 368 (368) 19470 1000 x 12 AHB6034 Potassium Chloride 0.298% (40) & Sodium Chloride 0.9% (154) 388 (388) 225806 1000 x 1 α Osmolarity is a calculated figure; in dilute condition, osmolarity is approximately the same as osmolality. The figures in the brackets are osmolality (mOsmol/kg). * _Not all codes are marketed_ For the full list of excipients, see section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Clear colourless solution for Intravenous Infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The Baxter Potassium Chloride and Sodium Chloride IV Infusion Olvassa el a teljes dokumentumot