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Date: Tuesday, October 19, 2021 14:59

Release 3.65
Vetivex® 1 (9 mg/ml) Solution for Infusion for Cattle, Horses, Dogs and Cats
 
Species: Horses and other equidae, Cats, Cattle, Dogs
Therapeutic indication: Pharmaceuticals: Dietary supplements and fluid metabolites: Oral rehydration and fluid replacements
Active ingredient: Sodium Chloride
Product:Vetivex® 1 (9 mg/ml) Solution for Infusion for Cattle, Horses, Dogs and Cats
Product index: Vetivex 1 (( mg/ml) Solution for Infusion for Cattle, Horses, Dogs and Cats
Cattle - milk: Zero hours
Cattle - meat: Zero days
Withdrawal notes: Horses: Meat and offal/milk - zero days/hours
Qualitative and quantitative composition
1 ml contains: Active substance:
Sodium chloride 9 mg
Sodium 150 mmol/litre
Chloride 150 mmol/litre
Pharmaceutical form
Solution for infusion. Clear, colourless solution.
Clinical particulars
Target species
Cattle, horses, dogs and cats.
Indications for use
This product is administered by intravenous infusion for the treatment of dehydration in cattle, 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.
Contraindications
Do not use in animals with:
- hypernatraemia
- hyperchloraemia
- hyperhydration
- oedema (hepatic, renal, or cardiac)
Special precautions for use in animals
Do not use unless the solution is clear, free from visible particles and the container is undamaged. 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.
Maintain aseptic precautions.
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.
Use with caution in animals with hypokalaemia.
Serum electrolyte levels, water and acid-base balance and the clinical condition of the animal should be closely monitored during the treatment in order to prevent overdose, particularly in cases of renal or metabolic changes.
This product should not be used for longer than is necessary to correct and sustain circulating volume. This solution does not contain the appropriate electrolyte balance for longer term maintenance fluid administration.
Inappropriate/excessive use may worsen or create a metabolic acidosis.
Use during 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 by the responsible veterinarian.
Interactions
It is recommended to take appropriate precautions in animals receiving corticosteroids or corticotrophins to prevent high blood pressure and excessive fluid retention during administration of large volumes.
Concomitant administration of colloids requires a dose reduction.
Amounts to be administered and administration route
Intravenous use.
The volume and rate of infusion will depend upon the clinical condition, existing deficits of the animal, maintenance needs and continuing losses.
Generally aim to correct hypovolaemia by 50% initially (ideally over 6 hours but faster if necessary) and reassess by clinical examination.
Deficits are generally in the range of 50 ml/kg (mild) to 150 ml/kg (severe). An infusion rate of 15 ml/kg/hour is recommended in the absence of shock (range 5-75 ml/kg/hour).
In shock, high initial infusion rates, up to 90 ml/kg/hour, are needed. High infusion rates should not be continued for longer than 1 hour unless urine output is restored. The maximum infusion rate should be decreased in the presence of cardiac, renal and pulmonary disease.
Overdose
It is recommended to maintain a serum sodium less than or equal to 130 mEq/l. In the presence of volume overload signs, treatment should involve administering diuretics and stopping the infusion.
Overdose may lead to hypernatraemia, hyperchloraemia, hypokalaemia, cardiac decompensation, hyperhydration and metabolic acidosis.
Clinical signs of excessive overdose include restlessness, hypersalivation, shivering, tachycardia, serous nasal discharge, tachypnoea, moist lung sounds, coughing, protrusion of the eye from the orbit, widespread oedema, vomiting and diarrhoea.
Long-term infusion may cause electrolyte imbalance. Saline solution is not balanced and it may cause acidaemia because it will increase renal elimination of bicarbonate. Prolonged use may cause hypokalaemia.
Withdrawal period
Meat and offal: zero days; Milk: zero hours.
Pharmacological particulars
Pharmacotherapeutic group: Electrolytes
ATCvet code: QB05BB01
Pharmacodynamic properties
Sodium chloride and water are normal constituents of the plasma of animals.
Sodium is the major cation of the extracellular space and regulates the size of this space together with other anions.
The sodium content and the fluid homeostasis of the body are closely related. Each deviation of the plasma sodium concentration from the physiological one simultaneously affects the fluid status of the body.
An increase in the sodium content of the body also means reduction of the body's free water content independent of the serum osmolarity.
A 0.9 per cent sodium chloride solution has the same osmolarity as plasma. Administration of this solution primarily leads to a replenishment of the interstitial space which is about 2/3 of the entire extracellular space. Only 1/3 of the administered volume remains in the intravascular space.
Pharmacokinetic properties
Sodium chloride administered by the intravenous route quickly joins the normal distribution and metabolism of sodium chloride and water, in the intracellular and extracellular spaces.
Sodium and chloride are normal components of the body and their balance is maintained by the kidneys. The sodium level of the veterinary medicinal product is similar to the physiological level in the serum.
The kidneys are the major regulator of the sodium and water balance. In cooperation with the hormonal control mechanisms (renin-angiotensin-aldosterone system, antidiuretic hormone), the kidneys are primarily responsible for the maintenance of a constant volume of the extracellular space and regulation of its fluid composition.
Chloride is exchanged for hydrogen carbonate in the tubule system. Thus, it is involved in the regulation of the acid-base balance.
Pharmaceutical particulars
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale:
100 ml: 18 months
500 ml, 1000 ml and 2000 ml: 2 years
The product should be used immediately and not stored after opening.
Special precautions for storage
Do not store above 25°C.
Do not freeze.
Immediate packaging
Polyvinylchloride infusion bag overwrapped with polypropylene.
Pack sizes: Individual fluid bags of 100 ml, 500 ml, 1000 ml and 2000 ml, each supplied with a package leaflet, or boxes containing 50 x 100 ml, 20 x 500 ml, 10 x 1000 ml, 4 x 2000 ml.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Dechra Limited, Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire, BD23 2RW, United Kingdom.
Marketing Authorisation Number
Vm 10434/4079
Significant changes
Date of the first authorisation or date of renewal
20 June 2013
Date of revision of the text
November 2018
Any other information
For animal treatment only. To be supplied only on veterinary prescription. Keep out of the sight and reach of children.
Manufacturer responsible for batch release: S C Infomed Fluids SRL, 50 Theodor Pallady blvd, District 3, 032266 Bucharest, Romania.
Legal category
Legal category: POM-V
GTIN
GTIN description:Vetivex 1 (9 mg/ml) Solution for Infusion for Cattle, Horses, Dogs and Cats:
GTIN:100 ml 05701170422153
GTIN description:Vetivex 1 (9 mg/ml) Solution for Infusion for Cattle, Horses, Dogs and Cats:
GTIN:500 ml 05701170422160
GTIN description:Vetivex 1 (9 mg/ml) Solution for Infusion for Cattle, Horses, Dogs and Cats:
GTIN:1000 ml 05701170422177
GTIN description:Vetivex 1 (9 mg/ml) Solution for Infusion for Cattle, Horses, Dogs and Cats:
GTIN:2000 ml 05701170422184