TERMIXTIM 800

COMPOSITION

Each gram of product contains 800 mg sodium salicylate (equivalent to 690 mg salicylic acid as sodium salt).

TARGET SPECIES

Cattle (calves) and pigs

INDICATIONS

Calves - Anti-pyretic support treatment in acute respiratory diseases, associated with adequate therapy (anti-infectious), if necessary.

Pigs - For the treatment of inflammation associated with concomitant antibiotic therapy

CONTRAINDICATIONS

Do not administer in animals with severe hypoproteinemia, severe liver and kidney disease.

Do not administer in case of gastrointestinal ulceration or chronic intestinal disorders.

Do not administer in the event of malfunction of the hematopoietic system, coagulopathies, haemorrhagic diathesis.

Do not use sodium salicylate in newborn calves or calves younger than 2 weeks old.

Do not use in piglets younger than 4 weeks.

Do not use in animals with known hypersensitivity to sodium salicylate or to the excipient.

ADVERSE REACTIONS

Gastrointestinal irritation may occur, especially in animals with preexisting gastrointestinal disorders. Such irritations can be clinically manifested by black faeces due to the elimination of blood in the gastrointestinal tract.

Accidental inhibition of normal blood clotting may occur. If this reaction occurs, it will be reversible and the effects will mitigate in about 7 days.

DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION

Cattle - 40 mg salicylate sodium/kg bw/day (50 mg product/kg bw/day) for 1-3 days

Pigs - 35 mg sodium salicylate/kg bw/day (43.75 mg product/kg bw/day) for 3-5 days

Termixtim 800 may be administered in milk replacement and/or drinking water.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

None.

WITHDRAWAL PERIOD(S)

Calves and pigs:

Meat and offal: 0 days 

SPECIAL PRECAUTIONS FOR STORAGE

Keep out of reach of children. This veterinary medicinal product does not require any special storage conditions. Store in the original package. 

SHELF LIFE

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf-life after first opening the original packaging: 28 days. Shelf-life after reconstitution in drinking water: 24 hours.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

Because sodium salicylate may inhibit blood clotting, it is recommended that no surgical investigation be performed less than 7 days after the end of treatment.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT:

Those with known hypersensitivity to sodium salicylate or similar substances (aspirin) or excipients should avoid contact with the veterinary medicinal product.

Irritations of the skin, eyes and respiratory tract may develop. During product preparation and mixing, direct contact with the skin and eyes should be avoided, as well as direct inhalation of the powder.

Wearing gloves, goggles and a dust mask is recommended. Special attention should be paid when opening the package.

In case of accidental skin exposure, immediately wash the skin with water.

In case of accidental eye contact, rinse eyes with plenty of water for 15 minutes and seek medical advice if irritation persists.

During the administration of medicated drinking water or medicated milk (milk replacement) to animals, contact with the skin should be prevented by wearing gloves. In case of accidental skin exposure, immediately rinse with water.

USE DURING PREGNANCY, LACTATION AND EGG-LAYING PERIOD

Laboratory studies in rats demonstrated the existence of teratogenic and foetotoxic effects.

Salicylic acid crosses the placenta and is excreted in milk. The half-life in newborns is longer, and therefore the symptoms of toxicity can occur much faster. In addition, platelet aggregation is inhibited, and bleeding time is increased, a situation that is not favourable during difficult births/caesarean operations. 

Finally, some studies indicate that calving is delayed.

The product must not be administered during gestation and lactation.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

Concomitant administration of potentially nephrotoxic medicinal products (e.g., aminoglycosides) should be avoided. Salicylic acid has a high degree of plasma binding (to albumin) and competes with a variety of compounds for plasma-protein binding sites (e.g., ketoprofen). Plasma clearance of salicylic acid has been reported to increase in association with corticosteroids, possibly due to the induction of salicylic acid metabolism. Concomitant use with NSAIDs is not recommended due to the increased risk of gastrointestinal ulceration. Do not use in combination with medicines with known anticoagulant properties.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

Calves tolerate doses up to 80 mg/kg for 5 days or 40 mg/kg for 10 days without adverse effects.

Pigs tolerate doses up to 175 mg/kg for 10 days without significant adverse effects. In case of acute overdose, the intravenous infusion of bicarbonate leads to increased clearance of salicylic acid by alkalising the urine and may be beneficial for the correction of acidosis.

INCOMPATIBILITIES

In the absence of compatibility studies, this medicinal product shall not be mixed with other veterinary medicinal products.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Medicines should not be disposed of via waste water or household waste.

The manufacturer recommends that the manure from the treated animals be handled and inactivated in accordance with the legislation in force to avoid contamination of the environment.

PRESENTATION/PACKAGE

25kg bags.