Quốc gia: Malta
Ngôn ngữ: Tiếng Anh
Nguồn: Medicines Authority
CALCIUM CHLORIDE, DIHYDRATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE
Baxter Healthcare Limited
B05BB01
CALCIUM CHLORIDE, DIHYDRATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE
SOLUTION FOR INFUSION
CALCIUM CHLORIDE DIHYDRATE 0.27 gram(s)/litre ; POTASSIUM CHLORIDE 0.4 gram(s)/litre ; SODIUM CHLORIDE 6 gram(s)/litre ; SODIUM LACTATE 3.2 gram(s)/litre
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Authorised
2004-10-07
Page 1 of 12 PACKAGE LEAFLET: INFORMATION FOR THE USER COMPOUND SODIUM LACTATE SOLUTION FOR INFUSION BP Active substances: sodium chloride, potassium chloride, calcium chloride dihydrate and sodium lactate 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. WHAT IS IN THIS LEAFLET 1. What Compound Sodium Lactate Infusion is and what it is used for 2. What you need to know before you are given Compound Sodium Lactate Infusion 3. How you will be given Compound Sodium Lactate Infusion 4. Possible side effects 5. How to store Compound Sodium Lactate Infusion 6. Contents of the pack and other information This medicine is called "Compound Sodium Lactate Solution for Infusion BP”, but will be referred to as "Compound Sodium Lactate Infusion” throughout the document. 1. WHAT COMPOUND SODIUM LACTATE INFUSION IS AND WHAT IT IS USED FOR Compound Sodium Lactate Infusion is a solution of the following substances in water: - sodium chloride - potassium chloride - calcium chloride dihydrate - sodium lactate. Sodium, potassium, calcium, chloride and lactate are chemical substances (electrolytes) found in the blood. Compound Sodium Lactate Infusion is used: - to treat a loss of body water and chemicals (e.g. by heavy sweating, kidney disorders) - to treat you, if the volume of blood in your blood vessels is low (hypovolaemia) or if you have low blood pressure (hypotension) - in metabolic acidosis (when the blood becomes too acidic). 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN COMPOUND SODIUM LACTATE INFUSION YOU MUST NOT RECEIVE COMPOUND SODIUM LACTATE INFUSION IF YOU ARE SUFFERING FROM ANY OF THE FOLLOWING CONDITIONS - if you’re a newborn (less than 28 days old) receiving ceftriaxone (an antibioti Đọc toàn bộ tài liệu
Page 1 of 13 1. NAME OF THE MEDICINAL PRODUCT Compound Sodium Lactate Solution for Infusion BP (Synonyms: - Ringer Lactate Solution for Infusion - Hartmann’s Solution for Infusion) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium Chloride: 6.00 g/l Potassium Chloride: 0.40 g/l Calcium Chloride dihydrate: 0.27 g/l Sodium Lactate: 3.20 g/l Na+ K+ Ca++ Cl- C 3 H 5 O 3 - (lactate) mmol/l 131 5 2 111 29 mEq/l 131 5 4 111 29 For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for infusion. Clear solution, free from visible particles. 278 mOsm/l (approx.) pH: 5.0 – 7.0 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Compound Sodium Lactate solution is used in the following indications: Restoration of extracellular fluid and electrolytes balances or replacement of extracellular fluid loss where isotonic concentrations of electrolytes are sufficient Short term volume replacement (alone or in association with colloid) in case of hypovolaemia or hypotension. Regulation or maintenance of metabolic acidosis balance and/or treatment of mild to moderate metabolic acidosis (except lactic acidosis) 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults, the Elderly and Children: _ Fluid balance, serum electrolytes and acid-base balance should 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 Page 2 of 13 hyponatraemia (see sections 4.4, 4.5 and 4.8). Monitoring of serum sodium is particularly important for hypotonic fluids. Compound Sodium Lactate solution has a tonicity of 278 mOsm/l (approx.) 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 intravenous flu Đọc toàn bộ tài liệu