Pays: Israël
Langue: anglais
Source: Ministry of Health
MAGNESIUM CHLORIDE HEXAHYDRATE; POTASSIUM CHLORIDE; SODIUM ACETATE TRIHYDRATE; SODIUM CHLORIDE; SODIUM GLUCONATE
TEVA ISRAEL LTD
B05BB01
SOLUTION FOR INFUSION
SODIUM GLUCONATE 5.02 G/L; SODIUM ACETATE TRIHYDRATE 3.68 G/L; MAGNESIUM CHLORIDE HEXAHYDRATE 0.30 G/L; POTASSIUM CHLORIDE 0.37 G/L; SODIUM CHLORIDE 5.26 G/L
I.V
Required
BAXTER HEALTHCARE LTD.UK
ELECTROLYTES
Indicated as a source of water and electrolytes or as an alkalinizing agent.
2020-01-27
The format of this leaflet was determined by the Ministry of Health and its content was checked and approved in January 2020 1 NAME OF THE MEDICINAL PRODUCT Plasma-Lyte ® 148 (pH 7.4) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium Chloride: .......................................................................................................... 5.26 g/l Potassium Chloride: ...................................................................................................... 0.37 g/l Magnesium Chloride hexahydrate: ............................................................................... 0.30 g/l Sodium Acetate trihydrate: ........................................................................................... 3.68 g/l Sodium Gluconate: ....................................................................................................... 5.02 g/l Na + K+ Mg ++ Cl - CH 3 COO - (Acetate) C 6 H 11 O 7 - (Gluconate) mmol/l 140 5.0 1.5 98 27 23 mEq/l 140 5.0 3.0 98 27 23 For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for intravenous (IV) infusion. Clear solution, free from visible particles Osmolarity: 295 mOsm/l (approx.) pH: approx. 7.4 (6.5 to 8.0) 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indicated as a source of water and electrolytes or as an alkalinizing agent. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Plasma-Lyte ® 148 (pH 7.4) is compatible with blood or blood components. It may be administered prior to or following the infusion of blood through the same administration set (i.e., as a priming solution), added to or infused concurrently with blood components, or used as a diluent in the transfusion of packed erythrocytes. Plasma-Lyte ® 148 (pH 7.4) and 0.9% Sodium Chloride Injection, USP are equally compatible with blood or blood components. All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile and nonpyrogenic equipment. As directed by a physician. Dosage, rate and duration of administration are to be i Lire le document complet