Země: Španělsko
Jazyk: angličtina
Zdroj: HMA (Heads of Medicines Agencies)
calcium chloride dihydrate 0.03 g/100 ml, potassium chloride 0.04 g/100 ml, sodium chlorite 0.6 g/100 ml, sodium lactate anhydrous dihydrate 0.31 g/100 ml
B. Braun VetCare SA
QB05BB01
Solution for infusion
electrolytes
Cats Non Food, Cattle Food, Dogs Non Food, Goats Food, Horses Food, Pigs Food, Sheep Food
2011-06-14
1 LABELLING AND PACKAGE LEAFLET 2 LABELLING 3 PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD-BOXES CONTAINING LOW DENSITY POLYETHYLENE BOTTLES 10 X 500 ML CARDBOARD-BOXES CONTAINING LOW DENSITY POLYETHYLENE BOTTLES 10 X 1000 ML CARDBOARD-BOXES CONTAINING PLASTIC BAGS OF 2 X 5000 ML 1. NAME OF THE VETERINARY MEDICINAL PRODUCT B. Braun Vet Care Hartmann’s Lactated Ringers Solution for infusion for cattle, horses, sheep, goats, pigs, dogs and cats. (In Spain: Lactato-RingerVet solución para perfusión para bovino, equino, ovino, caprino, porcino, perros y gatos.) (In Germany: Ringer-Lactat-Lösung nach Hartmann B. Braun Vet Care, Infusionslösung für Rinder, Pferde, Schafe, Ziegen, Hunde und Katzen.) 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES 100 ml contains: _ACTIVE SUBSTANCES: _ Sodium chloride 0.600 g Potassium chloride 0.040 g Calcium chloride dihydrate 0.027 g Sodium (S)- lactate 0.312 g (as sodium lactate solution (50% w/v) 0.624 g) Electrolyte concentrations: Sodium 130.49 mmol/l Potassium 5.37 mmol/l Calcium 1.84 mmol/l Chloride 111.70 mmol/l Lactate 27.84 mmol/l 3. PHARMACEUTICAL FORM Free from bacterial endotoxins. Theoretical osmolarity 277 mOsm/l Titration acidity < 1 mmol/l pH 5.0 - 7.0 Solution for infusion. 4. PACKAGE SIZE LDPE bottle: 10 x 500 ml, 10 x 1000 ml Plastic bag: 2 x 5000 ml 4 5. Přečtěte si celý dokument
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT B. Braun Vet Care Hartmann’ s Lactated Ringers Solution for infusion for cattle, horses, sheep, goats, pigs, dogs and cats. (In Spain (RMS): Lactato-RingerVet solución para perfusión para bovino, equino, ovino, caprino, porcino, perros y gatos) (In Germany: Ringer-Lactat-Lösung nach Hartmann B. Braun Vet Care, Infusionslösung für Rinder, Pferde, Schafe, Ziegen, Hunde und Katzen.) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 100 ml contains: Active substances: Sodium chloride 0.600 g Potassium chloride 0.040 g Calcium chloride dihydrate 0.027 g Sodium (S)-lactate 0.312 g (as sodium lactate solution (50% w/v) 0.624 g) For a full list of excipients, see section 6.1 Electrolyte concentrations: Sodium 130.49 mmol/l Potassium 5.37 mmol/l Calcium 1.84 mmol/l Chloride 111.70 mmol/l Lactate 27.84 mmol/l 3. PHARMACEUTICAL FORM Solution for infusion. Clear, colourless, aqueous and free from bacterial endotoxins. Theoretical osmolarity 277 mOsm/l Titration acidity < 1 mmol/l pH 5.0 - 7.0 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, horses, sheep, goats, pigs, dogs and cats. 2 4.2 INDICATIONS FOR USE Indication for all target animal species: - Isotonic dehydration - Metabolic acidosis - Hypotonic dehydration - Maintenance of normal extracellular fluid levels - Electrolyte replacement in burns 4.3 CONTRAINDICATIONS Do Přečtěte si celý dokument