Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
Glucose monohydrate; Sodium chloride; Potassium chloride; Magnesium chloride hexahydrate; Sodium acetate trihydrate; Sodium gluconate
Baxter Healthcare Limited
B05BB; B05BB02
Glucose monohydrate; Sodium chloride; Potassium chloride; Magnesium chloride hexahydrate; Sodium acetate trihydrate; Sodium gluconate
5 percent weight/volume
Solution for infusion
Product subject to prescription which may not be renewed (A)
Solutions affecting the electrolyte balance; electrolytes with carbohydrates
Marketed
2007-06-01
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PLASMA-LYTE 148 & GLUCOSE 5% W/V SOLUTION FOR INFUSION Active substances: glucose, sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate and sodium gluconate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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. See section 4. This medicine is called `Plasma-Lyte 148 & Glucose 5% w/v Solution for Infusion’, but will be referred to as `Plasma-Lyte & Glucose Infusion’ throughout the remainder of this leaflet. WHAT IS IN THIS LEAFLET : 1. What Plasma-Lyte & Glucose Infusion is and what it is used for 2. What you need to know before you are given Plasma-Lyte & Glucose Infusion 3. How you will be given Plasma-Lyte & Glucose Infusion 4. Possible side effects 5. How to store Plasma-Lyte & Glucose Infusion 6. Contents of the pack and other information 1. WHAT PLASMA-LYTE & GLUCOSE INFUSION IS AND WHAT IT IS USED FOR Pharmacotherapeutic group: “Electrolytes with Carbohydrates” - ATC code: “B05BB02” Plasma-Lyte & Glucose Infusion is a solution of the following substances in water: - sugar (glucose) - sodium chloride - potassium chloride - magnesium chloride hexahydrate - sodium acetate trihydrate - sodium gluconate Glucose is one of the body’s sources of energy. This solution for infusion provides 220 kilocalories per litre. Sodium, potassium, magnesium, chloride, acetate and gluconate are chemical substances found in the blood. Plasma-Lyte & Glucose infusion is used: - to provide a source of fluid and carbohydrate (sugar) for example, in cases of: - burns - head injury - fractures - infection - peritoneal irritation (inflammation within the abdomen) - as a source of fluids during a surgical operation - in metabolic acid read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Plasma-Lyte 148 & Glucose 5% w/v solution for infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Glucose monohydrate 55.00 g/l 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 a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. Clear solution, free from visible particles Osmolarity: 572 mOsm/l (approx.) pH: 4.0 to 6.0 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Plasma-Lyte 148 & Glucose 5% w/v is indicated: - for fluid replacement with carbohydrate supply (e.g. after burns, head injury, fracture, infection, and peritoneal irritation), - as intraoperative fluid replacement, - in mild to moderate metabolic acidosis, also in case of lactate metabolism impairment. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _3_ _1_ _/_ _0_ _5_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _2_ _2_ _7_ _0_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults, the Elderly, Adolescents and Children: The dosage and rate of administration depend on the age, weight, clinical and biological conditions of the patient and concomitant therapy. Fluid balance, blood glucose, and serum electrolytes should be monitor read_full_document