Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Sodium Chloride
Dechra Limited
QB05BB01
Sodium Chloride
Solution for infusion
POM-V - Prescription Only Medicine – Veterinarian
Cats, Cattle, Dogs, Horses
Replacement Agent
Authorized
1998-12-18
Revised: June 2016 AN: 01539/2015 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Hypertonic 7.2% w/v solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Sodium chloride 7.2% w/v Approximate ionic content in millimoles per litre: Sodium 1232 mmol/L Chloride 1232 mmol/L Excipients: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion. Clear, colourless solution. 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 as adjunctive therapy in the treatment of circulatory shock (hypovolaemic or endotoxaemic) in cattle, calves, horses, dogs and cats. 4.3 CONTRAINDICATIONS Do not administer to hypernatraemic animals. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Maintain aseptic precautions. Adequate access to drinking water should be provided when using the product. Revised: June 2016 AN: 01539/2015 Page 2 of 4 Care should be taken to avoid the use of excessive doses (>8 ml/kg) and excessive dose rates (>60 ml/kg/hr). The product should ideally be warmed to approximately 37°C prior to administration. Special precautions to be taken by the person administering the veterinary medicinal product to animals Not applicable. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Excessive doses and/or dose rates can cause hypernatraemia, hypotension, bradycardia, bronchoconstriction and hyperventilation. Sodium overload may occur particularly in animals with cardiac or renal impairment, and it should be noted that sodium excretion may be impaired post-surgery/trauma. It should also be noted that hypernatraemia may occur in animals that are dehydrated. A risk of thrombosis with intravenous infusion should be considered. 4.7 USE DURING PREGNANCY AND LACTATION OR LAY Use under veterinary supervision. 4.8 INTERAC Read the complete document