Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
SODIUM CHLORIDE POTASSIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE LACTIC ACID SODIUM HYDROXIDE
Bieffe Medital SpA
SODIUM CHLORIDE POTASSIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE LACTIC ACID SODIUM HYDROXIDE
1000 Millilitre
Solution for Infusion
Withdrawn
2007-02-06
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Compound Sodium Lactate (Hartmann’s Solution) Solution for Intravenous Infusion (1000 ml) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for infusion. Colourless, clear solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Electrolyte replenisher. - Maintenance or replacement of deficits in extracellular fluid. - Hypervolaemia. - Acid-base balance regulation. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Intravenous infusion according to the clinical situation and the intake output balance. 500ml to 3000 ml per 24 hours. 4.3 CONTRAINDICATIONS - Cardiac insufficiency. - Hypovolaemia, hypernatraemia, hyperkalaemia and hypercalcemia. - Oedema and cirrhotic ascites. - Lactic acidosis, alkalosis. 1000 ml of solution contains: Active Ingredients: mmol Sodium Chloride Ph. Eur. 6.00 g Sodium 131 Potassium Chloride Ph. Eur. 0.40 g Potassium 5 Calcium Chloride Ph. Eur. 0.27 g Calcium 2 Lactic Acid Ph. Eur. 2.60 g* Chloride 111 Sodium Hydroxide Dihydrate Ph. Eur. 1.17 g* Lactate 29 *Such quantities correspond to Anhydrous Sodium Lactate 3.25 g derived from Sodium Lactate 60% Total osmolarity 279.56 mOsm/1 For excipients, see 6.1 IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 25/10/2005_ _CRN 2016094_ _page number: 1_ 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Prior to use, check the condition of the bag. Do not use damaged bags. - Verify that the solution is clear and free of visible particles. - Check flow regulation. Prior to administration the solution should be warmed to approximately body temperature and after removal of the overwrap the bag should be squeezed to check for leaks. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION In prep Прочитать полный документ