Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Sodium chloride; Potassium chloride; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Sodium acetate trihydrate ; Glucose monohydrate
Fresenius Kabi Deutschland GmbH
B05BB; B05BB02
Sodium chloride; Potassium chloride; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Sodium acetate trihydrate ; Glucose monohydrate
Solution for infusion
Solutions affecting the electrolyte balance; electrolytes with carbohydrates
Not marketed
2016-09-16
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PAEDISOL SOLUTION FOR INFUSION (Sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate, and glucose monohydrate) 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, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Paedisol is and what it is used for 2. What you need to know before you use Paedisol 3. How to use Paedisol 4. Possible side effects 5. How to store Paedisol 6. Contents of the pack and other information 1. WHAT PAEDISOL IS AND WHAT IT IS USED FOR Paedisol is a solution for intravenous infusion (into a vein). It contains minerals called electrolytes that affect the amount of water in your body and other important processes. It also contains carbohydrates. Paedisol is used in new-born babies (0 to ≤28 days), babies (28 days to ≤2 years), children (2 to ≤12 years) and adolescents (12 to ≤14 years) as follows: • It helps to restore fluid levels and the normal electrolyte (salt) balance after an operation. It also contains glucose which provides a source of energy. • It acts as a plasma volume substitute that is used to restore the blood volume. • It helps to restore fluid and electrolyte deficiencies. • It is used as a carrier solution for other electrolytes and medicinal products. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PAEDISOL DO NOT USE PAEDISOL: • if your child is allergic (hypersensitive) to sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate, glucose or any of the other ingredients of this medicine (listed in section 6). • for premature neonates and neonates (≤28 days of age): Your child must not rec Les hele dokumentet
Health Products Regulatory Authority 22 September 2023 CRN00DKY6 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paedisol Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of Paedisol solution for infusion contains: Sodium chloride 6.429 mg Potassium chloride 0.298 mg Calcium chloride dihydrate 0.147 mg Magnesium chloride hexahydrate 0.203 mg Sodium acetate trihydrate 4.082 mg Glucose monohydrate (equivalent to Glucose 10.0 mg) 11.0 mg equivalent to: Na + 140 mmol/l; K + 4 mmol/l; Ca 2+ 1 mmol/l; Mg 2+ 1 mmol/l; Cl – 118 mmol/l; Acetate ions 30 mmol/l; Glucose 55.5 mmol/l Total cation/anion content 148 mval/l each, glucose 10 mg/ml. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. A clear, colourless to slightly yellow aqueous solution. pH: 5.3–5.7 Theoretical osmolarity: 351 mOsmol/l Titration acidity: to pH 7.4 ≤ 5 mmol/l Energy content: 168 kJ/l (40 kcal/l) Carbohydrate content: 10 g/l 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paedisol is indicated for paediatric patients such as neonates (0 to ≤28 days), infants (28 days to ≤2 years), children (2 to ≤12 years), and adolescents (12 to ≤14 years) as follows: – Perioperative plasma-isotonic fluid and electrolyte replacement with partial coverage of carbohydrate requirements, – Short-term intravascular volume replacement, – Treatment of isotonic dehydration, – Use as carrier solution for compatible electrolyte concentrates and medicinal products. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Health Products Regulatory Authority 22 September 2023 CRN00DKY6 Page 2 of 6 Posology _Paediatric population_ The dosage in perioperative intravenous infusion therapy depends on the fluid, electrolyte, and glucose requirements: During the first hour e.g. 10 – 20 ml/kg/hr, and thereafter for regulation of the infusion rate according to basic and correction requirements with monitoring of relevant cardiovascular and laboratory parameters. For fluid re Les hele dokumentet