Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Sodium chloride; Potassium chloride; Calcium chloride dihydrate; Sodium lactate (as 50% solution)
Fresenius Kabi Deutschland GmbH
B05BB; B05BB01
Sodium chloride; Potassium chloride; Calcium chloride dihydrate; Sodium lactate (as 50% solution)
Solution for infusion
Solutions affecting the electrolyte balance; electrolytes
Not marketed
2009-07-24
U15720/A IE PACKAGE LEAFLET: INFORMATION FOR THE USER HARTMANN'S SOLUTION For Infusion 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. See section 4. IN THIS LEAFLET: 1. What HARTMANN’S SOLUTION is and what it is used for? 2. What you need to know before you receive Hartmann's solution 3. How you are given HARTMANN’S SOLUTION? 4. Possible side effects 5. How to store HARTMANN’S SOLUTION? 6. Contents of the pack and other information 1. WHAT HARTMANN’S SOLUTION IS AND WHAT IT IS USED FOR ? HARTMANN’S SOLUTION is a sterile, colourless solution for infusion. It is used for the treatment of extracellular dehydration (water loss), hypovolaemia (sudden drop in volume of circulating blood) and metabolic acidosis (increased acid in the body). 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE HARTMANN'S SOLUTION You should not receive HARTMANN’S SOLUTION if you have: - hyperhydration (too much fluid) - decompensated congestive cardiac failure (your heart can't pump enough blood throughout the body) - hyperkalemia (too much potassium in your blood), - hypercalcemia (too much calcium in your blood), - metabolic alkalosis (too much alkalis such as bicarbonate in the blood), - in combination with digitalis (medicine used as cardiac stimulant) (see "Using other medicines" section). Your doctor will check these. SPECIAL CARE WILL BE TAKEN IF YOU: - suffer from swelling with sodium retention. - suffer from acute illness, pain, post-operative stress, infections, burns, or diseases of the central nervous system - have any type of heart, liver or kidney disease - have been treated with a medicine increasing the effect of vasopressin (a hormone regulating the body's water retention) because this may increase the r Aqra d-dokument sħiħ
Health Products Regulatory Authority 17 July 2020 CRN008J2H Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hartmann's Solution for Infusion, PE bottle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Bag : 50 ml 100 ml 250 ml 500 ml 1000 ml Sodium chloride (g) 0.30 0.60 1.50 3.00 6.00 Potassium chloride (g) 0.020 0.040 0.10 0.20 0.40 Dihydrated calcium chloride (g) 0.01 0.03 0.07 0.14 0.27 50% sodium lactate solution (g) 0.32 0.63 1.59 3.17 6.34 For full list of excipients, see section 6.1. Molar formula Bag : 50 ml 100 ml 250 ml 500 ml 1000 ml Sodium (mmol) 6.55 13.09 32.73 65.45 130.90 Potassium (mmol) 0.27 0.54 1.35 2.70 5.40 Calcium (mmol) 0.09 0.18 0.46 0.92 1.84 Chloride (mmol) 5.59 11.17 27.93 55.85 111.70 Lactate (mmol) 1.42 2.83 7.08 14.15 28.30 3 PHARMACEUTICAL FORM Solution for infusion. Osmolarity: 279 mOsm/l Osmolarity: 255 mOsm/kg pH: 5.5 to 6.3 Clear and colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Predominantly extracellular dehydration, regardless of cause (vomiting, diarrhea, fistulas, etc.). - Hypovolemia regardless of cause: hemorrhagic shock, burns, peri-operative water and electrolyte loss. - Mild metabolic acidosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY: This is determined by the physician according to clinical status, age and weight of the patient and according to laboratory findings. METHOD OF ADMINISTRATION: This solution must be given by slow intravenous infusion under strictly aseptic conditions. 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 products with lower sodium concentration compare Aqra d-dokument sħiħ