Riik: Malta
keel: inglise
Allikas: Medicines Authority
CALCIUM CHLORIDE, DIHYDRATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE
Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands
B05BB01
SODIUM CHLORIDE 8.6 g/l POTASSIUM CHLORIDE 0.3 g/l CALCIUM CHLORIDE DIHYDRATE 0.33 g/l
SOLUTION FOR INFUSION
SODIUM CHLORIDE 8.6 g/l POTASSIUM CHLORIDE 0.3 g/l CALCIUM CHLORIDE DIHYDRATE 0.33 g/l
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Authorised
2004-10-07
1 PACKAGE LEAFLET: INFORMATION FOR THE USER RINGER’S SOLUTION FOR INFUSION Active substances: sodium chloride, potassium chloride and calcium chloride dihydrate 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. WHAT IS IN THIS LEAFLET : 1. What Ringer’s Solution for Infusion is and what it is used for 2. What you need to know before you are given Ringer’s Solution for Infusion 3. How you will be given Ringer’s Solution for Infusion 4. Possible side effects 5. How to store Ringer’s Solution for Infusion 6. Contents of the pack and other information 1. WHAT RINGER’S SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR Ringer’s Solution for Infusion is a solution of the following substances in water: - sodium chloride - potassium chloride - calcium chloride dihydrate - Ringer’s Solution for Infusion is used to treat a loss of body water (dehydration) and chemicals (e.g. by heavy sweating, kidney disorders) 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN RINGER’S SOLUTION FOR INFUSION DO NOT RECEIVE RINGER’S SOLUTION FOR INFUSION IF YOU ARE SUFFERING FROM ANY OF THE FOLLOWING CONDITIONS - Preterm newborn infants and term newborn infants (≤28 days of age): Your child must not receive a certain antibiotic called ceftriaxone as a drip into a vein at the same time with this medicine - when there is too much fluid in the spaces around the cells of the body (extracellular hyperhydration) - when there is a larger volume of blood in the blood vessels than there should be (hypervolaemia) - severe kidney failure (when your kidneys do not work well and you require dialysis) - uncompensated heart failure. This is heart failure that is not adequately treated and causes symptoms such as: - shortness of bre Lugege kogu dokumenti
PAGE 1 OF 9 1. NAME OF THE MEDICINAL PRODUCT Ringer’s Solution for Infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium chloride: 8.60 g/l Potassium chloride: 0.30 g/l Calcium chloride dihydrate: 0.33 g/l mmol/l: Na + : 147 K + : 4 Ca ++ : 2.25 Cl - :155.5 mEq/l: Na + : 147 K + : 4 Ca ++ : 4.5 Cl - :155.5 For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM _ _ Solution for infusion. Clear solution, free from visible particles. Osmolarity: 309 mOsm/l (approx) pH: 5.0 to 7.5 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ringer’s Solution for Infusion is indicated to: _-_ _ _ Replace extracellular fluid losses, _-_ _ _ Restore the sodium, potassium, calcium and chloride balances, for treatment of isotonic dehydration 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults, the Elderly, Adolescents and Children_ : Fluid balance, serum electrolytes and acid-base balance may need to be monitored before and during administration, with particular attention to serum sodium in patients with increased non- osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients co-medicated with vasopressin agonist drugs, due to the risk of hospital acquired hyponatraemia (see sections 4.4, 4.5 and 4.8). Monitoring of serum sodium is particularly important for hypotonic fluids. Ringer’s Solution tonicity: Isotonic solution The infusion rate and volume depend on the age, weight, clinical condition (e.g. burns, surgery, head-injury, infections), and concomitant therapy should be determined by the consulting physician experienced in paediatric intravenous fluid therapy (see sections 4.4. and 4.8). _Recommended dosage: _ The recommended dosage is: - for adults, the elderly and adolescents : 500 ml to 3 liters /24h - for babies and children : 20 ml to 100 ml / kg / 24 h _Administration rate: _ The infusion rate is usually 40 ml/kg/24h in adults, the elderly and adolescents. In paediatric patients the infusion rate is 5 ml/kg/h in average but the value Lugege kogu dokumenti