SPIROVET 100 ML – Spiramycin – Solution for injection

NAME OF VETERINARY MEDICINAL PRODUCT
SPIROVET 600,000 IU/ml,

solution for injection for cattle.

DECLARATION OF ACTIVE SUBSTANCES AND OTHER INGREDIENTS
1 ml. of solution contains:
Spiramycin 600 000 IU;
Benzyl alcohol 41.6 mg;
Clear yellow solution.

INDICATIONS
Treatment of acute clinical mastitis in lactating cows caused by Staphylococcus aureus
Strains sensitive to spiramycin. Treatment of respiratory infections caused by Pasteurella multocida and Mannheimia haemolytica.

CONTRAINDICATIONS
Do not use in case of hypersensitivity to spiramycin.

ADVERSE REACTIONS
At the injection site, the product can sometimes induce some macroscopic lesions, which may persist
more than 42 days.
In cattle, hypersalivation may occur 3 hours after administration.
If you notice any serious reactions or other effects that are not listed in this leaflet, please inform your veterinarian.

TARGET SPECIES
Cattle, pigs.

DOSAGE FOR EACH SPECIES, ROUTE OF ADMINISTRATION AND METHOD OF ADMINISTRATION
It is administered intramuscularly:
Body mass should be determined as correctly as possible to avoid underdosing.
Mastitis: 30 000 IU spiramycin/kg body weight (e.g. 5 ml product per 100 kg
body mass), two doses 24 hours apart.
Respiratory infections: 100,000 IU spiramycin/kg body weight (e.g. 5 ml product per 30 kg body weight), two doses 48 hours apart.

RECOMMENDATIONS ON CORRECT ADMINISTRATION
Do not administer more than 15 ml in one place.
This means that the dose should be divided into two injections, then the injections should be done on opposite sides of the neck. If more than 2 injections are needed, a distance of at least 15 cm should be maintained between injections on the same side of the neck.
For the second dose (after 24 or 48 hours), the same protocol should be followed, making sure to keep a distance of at least 15 cm between all places of administration of the product. This procedure is necessary so that the injection sites remain separate. Failure to follow these instructions may result in exceeding the maximum residue limit of 200 μg/kg for muscles.

WAITING TIME
Mamitis:
Meat and organs: 75 days.
Milk: 13.5 days.
Respiratory infections:
Meat and offal: 75 days.
Milk: In the case of appropriate dose treatment for respiratory infections, the product is not authorised for use in animals producing milk for human consumption.

PRECAUTIONS FOR USE IN ANIMALS
Do not administer to cattle more than 15 ml in one place.
The use of the product must be based on antibiotic resistance tests of bacteria isolated from animals. If this is not possible, therapy should be based on local epidemiological information (regional, farm–level) about the susceptibility of the target bacteria. Using the product outside the instructions in the leaflet may increase the prevalence of bacterial resistance to spiramycin. Official, national and regional antimicrobial policies should be taken into account when using the product.
Mammoths caused by S. aureus should be treated only after clinical signs appear. Only acute cases of mastitis caused by S. aureus with clinical signs kept under observation for at least 24 hours should be treated.

USE DURING PREGNANCY, LACTATION OR LAYING
No teratogenicity phenomena have been reported in mice. Maternotoxic oral doses caused embryotoxicity in rabbits. The safety of the product has not been established in cows during gestation and lactation. However, the use of the product during pregnancy and lactation should not cause toxicological concerns. Laboratory studies in dogs and rats have shown effects on spermatogenesis with the use of high doses of 2,050,000 IU/kg body weight per day for 56 days. The safety of the product has not been established in breeding males. In the case of these animals, the use of the product will be made after the evaluation by the veterinarian of the benefit.