Target species
Cattle, calves, horses, dogs and cats.
Indications for use for each target species
In all target species:
As adjunctive therapy in the treatment of circulatory shock (hypovolaemic or endotoxaemic).
Contraindications
Do not use in animals with:
Hypertonic hyperhydration (characterised by oedema);
Renal insufficiency;
Severe electrolyte disturbances;
Uncontrolled haemorrhage;
Pulmonary oedema;
Retention of water and sodium chloride;
Cardiac insufficiency;
Hypertension;
Hypertonic dehydration (characterised by thirst).
Special warnings
None
Special precautions for use
Special precautions for safe use in the target species:
Do not use unless the solution is clear, free from visible particles, and the container is undamaged.
Maintain aseptic precautions.
Administration of the solution must be accompanied by an opportunity for the animal to drink ad libitum.
This veterinary medicinal product should ideally 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.
Any existing haemorrhage should be stopped or controlled before treatment.
Hypertonic solutions must be administered solely by the intravenous route.
Animals treated with this veterinary medicinal product should be closely observed for possible deterioration of the clinical condition as a consequence of treatment.
Repeated infusion should only be performed after checking sodium concentration and acid-base status.
Rapid infusion of hypertonic NaCl can lead to myelinolysis in the brain in animals with chronic hyponatraemia.
Do not use the product as a vehicle for the administration of other veterinary medicinal products.
Care should be taken to avoid the use of excessive doses (>8 ml/kg) and excessive dose rates (>1 ml/kg/minute).
Excessive administration of chloride may, due to the electrolytes' interaction with the body's bicarbonate buffer system exert an acidifying effect. Therefore, in clinical instances accompanied by acidosis and hyperchloraemia, special care has to be taken if this veterinary medicinal product is to be infused.
Sodium chloride administration may aggravate a pre-existing hypokalaemia.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
None.
Adverse events
Cattle, cattle (calves), horses, dogs and cats:
Very rare (<1 animal/10,000 animals treated, including isolated reports): | Deatha |
Undetermined frequency (cannot be estimated from the available data) | Hypokalaemiab, Haemolysisc, Haemoglobinuriac Oedemac, d Hypotensionc, Arrhythmiac Pulmonary oedemac,d, Respiratory tract disorderc,e, Hyperventilationc Polyuriaf Thrombosis Injection site paing |
a Due to erroneous administration of sodium to dehydrated animals which may increase the existing extracellular hypertonia, with aggravation of existing disorders.
b May be induced by an excess of sodium and may be aggravated by the existence of continued loss of potassium and hyperchloraemia.
c After rapid administration.
d Especially in cases of concurrent cardiac or renal insufficiency.
e Bronchoconstriction.
f With formation of hypertonic urine.
g Administration into small peripheral veins may cause signs of pain.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Use only accordingly to the benefit/risk assessment of the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
Administer with care to animals that have had prolonged treatment with corticosteroids having a mineralcorticoid action.
Administration routes and dosage
Intravenous use.
The infusion should ideally be warmed to approximately 37°C prior to administration.
Recommended doses are in the range 4-8 ml/kg, and an infusion rate of 1 ml/kg/minute should not be exceeded.
The veterinary medicinal product should be used in conjunction with conventional fluid therapy. The administration of the product is usually followed by the intravenous administration of an isotonic intravenous fluid (e.g. an intravenous 0.9% sodium chloride solution).
Fluid output, plasma sodium concentration and blood pressure should be monitored.
Adequate access to drinking water should also be provided.
Strict observation of the patient is necessary to safeguard the maintenance of correct diuresis.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Overdose of hypertonic sodium chloride solution may lead to an increase in the extracellular volume (extracellular hyperhydration).
Hyperhydration is manifest by agitation and hypersalivation: in these cases, it is appropriate to reduce the rate of infusion drastically or to stop the infusion.
Strict observation of the patient is needed to avoid causing cardiovascular overload and pulmonary or cerebral oedema.
An increase of serum osmolarity over 350 mOsm/l may produce cerebral dysfunction and coma.
Overdose of the veterinary medicinal product can cause hypernatraemia. If hypernatraemia is present, it should be corrected slowly, using water orally if possible, or intravenous 0.9% sodium chloride solution, or for less severe hypernatraemia, an intravenous isotonic electrolyte solution with a low sodium chloride concentration.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable
Withdrawal period(s)
Meat and offal: Zero days.
Milk: Zero hours.