Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Anhydrous citric acid; Potassium chloride; Sodium chloride ; Sodium hydrogen carbonate; Glycine; Lactose monohydrate
Zoetis Belgium S.A.
QB05XA
Anhydrous citric acid; Potassium chloride; Sodium chloride ; Sodium hydrogen carbonate; Glycine; Lactose monohydrate
. gram/tablet
Effervescent tablet
LM: Licensed Merchant as defined in relevant national legislation
Cattle
Electrolyte solutions
Electrolytes
Authorised
2013-12-09
Health Products Regulatory Authority 31 July 2017 CRN000TZ9 Page 1 of 5 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Effydral Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains : Active substance Sodium chloride 2.34 g Potassium chloride 1.12 g Sodium hydrogen carbonate 6.72 g Anhydrous citric acid 3.84 g Lactose monohydrate 32.44 g Glycine 2.25 g When one Effydral tablet is dissolved in 1 litre of water, the resulting isotonic oral rehydration solution has the following composition: Constituent (mmol/l) Sodium 120 Potassium 15 Chloride 55 Bicarbonate + citrate 80* Lactose 90** Glycine 30 * Total alkali expressed as bicarbonate equivalents ** 90 mmol lactose is equivalent to 180 mmol glucoseFor a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Effervescent tablet. Health Products Regulatory Authority 31 July 2017 CRN000TZ9 Page 2 of 5 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Calves 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Effydral solution corrects dehydration, electrolyte loss and metabolic acidosis, particularly when these disturbances arise as a consequence of diarrhoea. Effydral has been specially developed for the treatment of diarrhoea in calves. 4.3 CONTRAINDICATIONS If the gastro-intestinal tract is completely obstructed, great care should be taken when administering oral solutions. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS For oral administration only. Always use clean water and equipment when preparing Effydral solution. Replace with fresh solution every 24 hours. Follow the instructions for use exactly. Use of a too-dilute Effydral solution will have a reduced efficacy while use of a too-concentrated solution may result in osmotic diarrhoea. If a too-concentrated solution is fed, ensure that the animal has free access to drinking water. Ensure that newborn animals receive adequate colostrum. In very severe cases of dehydration additional intravenous fluid therapy may be requi Aqra d-dokument sħiħ