Target species
Turkeys.
Indications for use
Symptomatic treatment of inflammatory respiratory diseases, if necessary in combination with an appropriate anti-infective therapy.
Contraindications
Do not use in cases of known hypersensitivity to the active substance.
Do not use in case of severe liver and kidney disorders.
Do not use in case of gastrointestinal ulcerations and chronic gastrointestinal disorders.
Special warnings for each target species
The compatibility of the product with other veterinary medicinal products when administered via the drinking water has not been investigated. If used concurrently, the stability and/or solubility of the veterinary medicinal products may change. Therefore, it is recommended that methods or routes of administration other than via drinking water are used to deliver concurrent anti-infective therapy, if needed.
Special precautions for use in animals
Diseased animals may show altered intake of drinking water or feed. In cases of altered drinking water intake, the concentration of the veterinary medicinal product has to be adjusted to ensure the intake of the required dose.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity (allergies) to sodium salicylate or related substances (eg aspirin) should avoid contact with the product.
Irritation of the skin, eyes, and respiratory tract may occur in the case of accidental contact. Direct contact of the skin and eyes with the medicated water or the powder, and inhalation of the powder should be avoided. It is recommended to wear protective gloves (eg rubber or latex), safety glasses, and an appropriate dust mask (eg disposable half-mask respirator conforming to European Standard EN149). Swelling of the face, lips or eyes or difficulty in breathing are serious symptoms that require immediate medical attention.
In case of accidental dermal exposure, wash skin immediately with water.
In the event of accidental eye contact, wash the eye with plenty of water for 15 minutes, and seek medical advice if irritation persists and show the label to the physician.
Adverse reactions
Turkeys:
Undetermined frequency (cannot be estimated from the available data) | Gastrointestinal irritationa (Tarry or black stoolb ) Drinking a lotc |
a especially in animals with pre-existing gastrointestinal disease.
b due to bleeding in the gastrointestinal tract.
c increase in water intake.
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.
Use during pregnancy and lactation
Laying birds:
Laboratory studies in rats have shown evidence of teratogenic and foetotoxic effects.
The use is not recommended during lay.
Interactions
Concurrent administration of potentially nephrotoxic drugs (eg aminoglycosides) should be avoided.
Salicylic acid is highly plasma (albumin) bound and competes with a variety of compounds (eg sulfonamides, ketoprofen) for plasma protein binding sites.
Concurrent use with other non-steroid anti-inflammatory drugs (NSAIDs) is not recommended, because of increased risk of gastro-intestinal disturbances.
Amounts to be administered and administration route
In-drinking water use.
86,2 mg salicylic acid/kg body weight daily (equivalent to100 mg product/kg body weight daily) for 3 consecutive days.
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:
100 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 |
Average daily water consumption (l/animal) | | |
The maximum solubility of the veterinary medicinal product in drinking water is approximately 100 g/litre.
For weighing the calculated amount of sodium salicylate the use of suitably calibrated weighing equipment is recommended.
Medicated drinking water should be freshly prepared every 24 hours.
Any medicated water which is not consumed within 24 hours should be discarded and the medicated drinking water replenished.
In order to ensure consumption of the medicated water, animals should not have access to other water supplies whilst being on treatment.
Overdose
The administration of four times the recommended dose resulted in an increase in drinking water consumption and occasional diarrhoea.
Withdrawal periods
Meat and offal: 2 days.
Not for use in birds producing or intended to produce eggs for human consumption.