Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Sodium Chloride
Dechra Limited
QB05BB01
Sodium Chloride
Expired
AN:00121/2013 Revised: June 2013 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Isolec 1 (Sodium Chloride 0.9 % w/v Intravenous Infusion BP (Vet)) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium Chloride 0.9 % w/v Approximate ionic content in millimoles per litre: Sodium 150 mmol/L Chloride 150 mmol/L 3. PHARMACEUTICAL FORM Solution for infusion. Clear, colourless solution for infusion. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, calves, horses, dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES This product is administered by intravenous infusion for the treatment of dehydration in cattle, calves, horses, dogs and cats. It may be used to correct hypovolaemia resulting from shock or gastrointestinal disease (especially where metabolic alkalosis is present, e.g. in cases of sustained vomiting or abomasal disorders in cattle). It may be administered to meet normal fluid and electrolyte requirements when fluids cannot be given orally. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Page 1 of 5 AN:00121/2013 Revised: June 2013 4.5 SPECIAL PRECAUTIONS FOR USE i Special precautions for use in animals Sodium overload may occur in animals with cardiac or renal impairment. It should be noted that sodium excretion may be impaired post-surgery/trauma. A risk of thrombosis with intravenous infusion should be considered. The product should be warmed to approximately 37 ° C prior to the administration of large volumes, or if the administration rate is high, in order to avoid hypothermia. This product should not be used for longer than is necessary to correct and sustain circulating volume. Inappropriate/excessive use may worsen or create a metabolic acidosis. Maintain aseptic precautions. ii Special precautions to be taken by the person administering the veterinary medicinal product to animals No special precautions required. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Excessive infusion rates can cause restlessness, moist lung s Read the complete document