국가: 몰타
언어: 영어
출처: Medicines Authority
CALCIUM CHLORIDE, DIHYDRATE, POTASSIUM CHLORIDE, MALIC ACID, MAGNESIUM CHLORIDE, HEXAHYDRATE, SODIUM ACETATE, TRIHYDRATE, SODIUM CHLORIDE
B Braun Melsungen AG Carl-Braun-Strasse 1, D34212 Melsungen, Germany
B05BB01
CALCIUM CHLORIDE DIHYDRATE 0.37 g/l POTASSIUM CHLORIDE 0.3 g/l L-MALIC ACID 0.67 g/l MAGNESIUM CHLORIDE HEXAHYDRATE 0.2 g/l SODIUM ACETATE TRIHYDRATE 3.27 g/l SODIUM CHLORIDE 6.8 g/l
SOLUTION FOR INFUSION
CALCIUM CHLORIDE DIHYDRATE 0.37 g/l POTASSIUM CHLORIDE 0.3 g/l L-MALIC ACID 0.67 g/l MAGNESIUM CHLORIDE HEXAHYDRATE 0.2 g/l SODIUM ACETATE TRIHYDRATE 3.27 g/l SODIUM CHLORIDE 6.8 g/l
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Authorised
2013-03-15
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER STEROFUNDIN ISO 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 pharmacist. - If you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Sterofundin ISO is and what it is used for 2. What you need to know before you receive Sterofundin ISO 3. How to use Sterofundin ISO 4. Possible side effects 5. How to store Sterofundin ISO 6. Contents of the pack and other information 1. WHAT STEROFUNDIN ISO IS AND WHAT IT IS USED FOR Sterofundin ISO is a solution for infusion into a vein. This solution replaces fluid that has been lost from the circulation. It can be used in conditions where your blood may become or has become slightly acidic. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE STEROFUNDIN ISO YOU WILL NOT BE GIVEN STEROFUNDIN ISO if you have – too much fluid in the circulation, – severe heart disease with shortness of breath and swelling of the feet or the legs, – severe kidney disease and you are unable or almost unable to pass urine, – swelling of your body tissues due to fluid accumulation, – high levels of potassium or calcium in your blood, – or if your blood is too alkaline. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Sterofundin ISO. Special care will be taken with Sterofundin ISO Solution for infusion, if you have – any disease that makes it necessary to reduce your salt intake, such as mild or moderately impaired heart function, tissue swelling or fluid accumulation in the lungs Page 2 of 7 – sarcoidosis (a chronic immune system disorder involving the lymph nodes and the connective tissue) – mildly or moderately increased blood pressure – acute water deficit e.g. following extensive tissue 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sterofundin ISO, solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1000 ml Sterofundin ISO solution for infusion contain: Sodium chloride 6.80 g Potassium chloride 0.30 g Magnesium chloride hexahydrate 0.20 g Calcium chloride dihydrate 0.37 g Sodium acetate trihydrate 3.27 g L-Malic acid 0.67 g Electrolyte concentrations: mmol/l Sodium 145.0 Potassium 4.0 Magnesium 1.0 Calcium 2.5 Chloride 127.0 Acetate 24.0 Malate 5.0 Excipients with known effect: 1000 ml Sterofundin ISO solution contain 0.2 g Sodium hydroxide (0.115 g Sodium). For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for infusion. A clear, colourless aqueous solution free from visible particles. pH: 5.1 – 5.9 Theoretical osmolarity: 309 mosm/l. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Replacement of extracellular fluid losses in the case of isotonic dehydration, where acidosis is present or imminent. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults, the elderly, adolescents and children: The dosage depends on the age, weight, clinical and biological conditions of the patient and concomitant therapy. Recommended dosage: The recommended dosage is: - for adults, the elderly and adolescents : 500 ml to 3 litres /24h, corresponding to 1 to 6 mmol sodium / kg / 24 h and 0.03 to 0.17 mmol potassium / kg / 24 h. _ _ - for toddlers, infants and children : 20 ml to 100 ml / kg / 24 h, corresponding to 3 to 14 mmol sodium / kg / 24 h and 0.08 to 0.40 mmol potassium / kg / 24 h. Administration rate: The maximum infusion rate depends on the needs of the patient in fluid replacement and electrolytes, his weight, clinical condition, and biological status. In paediatric patients the infusion rate is 5 ml/kg/h on average but the value varies with age: 6-8 ml/kg/h for infants, 4-6 ml/kg/h for toddlers, and 2-4 ml/kg/h for children. Note: • infants and toddlers: age ranges from about 28 days to 23 months (a toddler is an infant who 전체 문서 읽기