Target species
Cattle (calves) and pigs.
Indications for use
Calves: Supportive treatment of pyrexia in acute respiratory disease, in combination with appropriate (e.g. anti-infective) therapy if necessary.
Pigs: For the treatment of inflammation in combination with concurrent antibiotic therapy.
Contraindications
Do not administer in case of severe hypoproteinaemia, liver and kidney disorder.
Do not administer in case of gastrointestinal ulcerations and chronic gastrointestinal disorders.
Do not administer in case of malfunction of the haemopoietic system, coagulopathy, haemorrhagic diathesis.
Do not use sodium salicylates in neonates or calves less than 2 weeks of age.
Do not use in piglets of less than 4 weeks of age.
Do not use in cases of hypersensitivity to the active substance.
Special precautions for use in animals
Given that sodium salicylate may inhibit clotting of the blood, it is recommended that elective surgery should not be performed on animals within 7 days after the end of treatment.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to sodium salicylate or related substances (e.g. aspirin) should avoid contact with the veterinary medicinal product.
Irritation of the skin, eye, and respiratory tract might occur. During preparation and mixing of the veterinary medicinal product, direct contact with the skin and eyes, and inhalation of the powder should be avoided. It is recommended to wear gloves, safety glasses and a dust mask.
In case of accidental dermal exposure wash skin immediately with water.
In the event of accidental eye contact, the user is advised to wash the eye with plenty of water for 15 minutes, and seek medical advice if irritation persists.
During administration of medicated water or milk (replacer) to the animals, skin contact should be prevented by wearing gloves. Wash accidentally exposed skin immediately with water.
Adverse reactions
Cattle (Calves) and pigs:
GB:
Undetermined frequency (cannot be estimated on the available data) | Gastrointestinal irritationa (Tarry or black stoolb ), Prolonged bleedingc |
a especially in animals with pre-existing gastrointestinal disease.
b due to bleeding in the gastrointestinal tract.
c inhibition of normal blood clotting may occur incidentally. This effect is reversible and diminishes within approximately 7 days.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also the last section of the package leaflet for contact details.
NI:
Undetermined frequency (cannot be estimated from the available data) | Gastrointestinal irritationa (tarry or black stoola+b), Prolonged bleedingc |
a especially in animals with pre-existing gastrointestinal disease.
b due to bleeding in the gastrointestinal tract.
c inhibition of normal blood clotting may occur incidentally. This effect is reversible and diminishes within approximately 7 days.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the combined label-leaflet for respective contact details.
Use during pregnancy and lactation
The use is not recommended during pregnancy and lactation because laboratory studies in rats have shown evidence of teratogenic and foetotoxic effects. Salicylic acid crosses the placenta and is excreted with the milk. Half-life in the newborn is longer and thus toxicity symptoms may occur much sooner. Furthermore, platelet aggregation is inhibited and bleeding time increased, which is not favourable during difficult parturition/caesarean section. Finally, some studies indicate that parturition is postponed.
Interactions
Concurrent administration of potentially nephrotoxic drugs (e.g. aminoglycosides) should be avoided.
Salicylic acid is highly plasma (albumin) bound and competes with a variety of compounds (e.g. ketoprofen) for plasma protein binding sites.
Plasma clearance of salicylic acid has been reported to increase in combination with corticosteroids, possibly due to induction of metabolism of salicylic acid.
Concurrent use with other non-steroid anti-inflammatory drugs (NSAIDs) is not recommended, because of increased risk of gastrointestinal ulceration.
Drugs which affect blood clotting should not be used in combination with sodium salicylate.
Amounts to be administered and administration route
In drinking water/milk use.
Calves: 40 mg sodium salicylate per kg body weight once daily, for 1-3 consecutive days.
Administration: Orally in drinking water or milk (replacer).
Pigs: 35 mg sodium salicylate per kg body weight per day, for 3-5 consecutive days.
Administration: Orally in drinking water.
Based on the recommended dose and the number and weight of animals to be treated, the exact daily concentration of the veterinary medicinal product should be calculated according to the following formula:
___ mg veterinary medicinal product/kg body weight/day x average body weight (kg) of animals to be treated | | |
________________________________________ | = | ___ mg veterinary medicinal product per litre of drinking water/milk |
Average daily water/milk consumption (l/animal) | | |
Alternatively the veterinary medicinal product can also be administered with the drinking water as pulse medication. Half of the calculated total daily amount of powder is mixed with 5-10 litres of clean water and stirred until evenly dispersed. This solution is then added, whilst stirring, into an amount of drinking water that will be consumed within approximately 3-4 hours and administered twice daily.
Maximum solubility of the veterinary medicinal product in water is approximately 100 g/litre.
The use of suitably calibrated weighing equipment for the administration of the calculated amount of sodium salicylate is recommended.
Overdose
Calves tolerate dosages up to 80 mg/kg for 5 days or 40 mg/kg for 10 days without any adverse effects.
Pigs tolerate dosages up to 175 mg/kg for up to 10 days without any significant adverse effects.
In case of an acute overdose, intravenous bicarbonate infusion results in a higher clearance of salicylic acid by alkalisation of the urine and may be beneficial in correcting (secondary metabolic) acidosis.
Withdrawal periods
Meat and offal:
Pigs: zero days.
Calves: zero days.
Not authorised for use in animals producing milk for human consumption.