Krajina: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
SODIUM CHLORIDE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE HEXAHYDRATE; SODIUM ACETATE TRIHYDRATE; SODIUM GLUCONATE
Baxter Healthcare Limited
B05BB01
SODIUM CHLORIDE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE HEXAHYDRATE; SODIUM ACETATE TRIHYDRATE; SODIUM GLUCONATE
SOLUTION FOR INFUSION
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
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Authorised
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PLASMA-LYTE 148 (PH 7.4) SOLUTION FOR INFUSION Active substances: sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate and sodium gluconate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. This medicine is called `Plasma-Lyte 148 (pH 7.4) Solution for Infusion’, but will be referred to as `Plasma-Lyte 148 (pH 7.4) infusion’ throughout the remainder of this leaflet. WHAT IS IN THIS LEAFLET: 1. What Plasma-Lyte 148 (pH 7.4) Infusion is and what it is used for 2. What you need to know before you use Plasma-Lyte 148 (pH 7.4) Infusion 3. How to use Plasma-Lyte 148 (pH 7.4) Infusion 4. Possible side effects 5. How to store Plasma-Lyte 148 (pH 7.4) Infusion 6. Contents of the pack and other information WHAT PLASMA-LYTE 148 (PH 7.4) INFUSION IS AND WHAT IT IS USED FOR Pharmacotherapeutic group: “Electrolytes” - ATC code: “B05BB01” Plasma-Lyte 148 (pH 7.4) Infusion is a solution of the following substances in water: - sodium chloride - potassium chloride - magnesium chloride hexahydrate - sodium acetate trihydrate - sodium gluconate Sodium, potassium, magnesium, chloride, acetate and gluconate are chemical substances found in the blood. Plasma-Lyte 148 (pH 7.4) infusion is used: - to provide a source of fluid, for example in cases of: - burns - head injury - fractures - infection - peritoneal irritation (inflammations within the abdomen) - as a source of fluids during a surgical operation - for the treatment of shock due to loss of blood and for other conditions needing rapid replacement of blood and/or fluids - in metabolic acidosis (when the blood becomes too acid) that is not life-threatening - lactic acidosis Prečítajte si celý dokument
Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Plasma-Lyte ® 148 (pH 7.4) solution for infusion. 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 - C 6 H 11 O 7 - (Acetate) (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 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 Plasma-Lyte 148 (pH 7.4) is indicated: - for fluid replacement (e.g. after burns, head injury, fracture, infection, and peritoneal irritation), - as intraoperative fluid replacement, - in haemorrhagic shock and clinical conditions requiring rapid blood transfusions (compatibility with blood), - in mild to moderate metabolic acidosis, also in case of lactate metabolism impairment. - Page 2 of 12 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: _ADULTS, OLDER PATIENTS AND ADOLESCENTS (AGE 12 YEARS AND OVER): _ The dosage and rate of administration depend on the age, weight, clinical and biological conditions of the patient and concomitant therapy. The recommended dosage is: 500 ml to 3 litres / 24 h _Administration rate: _ The infusion rate is usually 40 mL/kg/24h in adults, the elderly and adolescents. When used for intraoperative fluid replacement, normal rate can be higher and is about 15 mL/kg/h. _Us Prečítajte si celý dokument