Product features

Injectable solution

Composition
Each ml contains:
Active substance:
Spiramycin 600 000 IU
Excipient:
Benzyl alcohol (E 1519) 41.6 mg

Indications
Diseases caused by spiramycin susceptible bacteria.

  • Cattle (adults), treatment of:
    • Respiratory diseases,
    • Mastitis,
    • Metritis,
    • Interdigital necrobacillosis (foul in the foot).
  • Sows:
    Treatment of mastitis.

Contra-indications
Do not use in animals known for their hypersensitivity to spiramycin or to any of the excipients.

Special precautions

Special precautions for use in animals
In cattle, do not administer more than 15 ml per injection site. In sows, do not administer more than 7 ml per injection site. Due to the likely variability (time, geographical) in the occurrence of resistance of bacteria for spiramycin, bacteriological sampling and susceptibility testing are recommended.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Care should be taken when handling the product to avoid self-injection. In case of accidental self-injection, seek medical advice, and show the package leaflet. People with known hypersensitivity to spiramycin and/or to other macrolides or to the components of the formulation should avoid contact with the product. Wash hands after handling the product. In case of accidental eye exposure, wash with plenty of water. In case of accidental contact with skin, rinse immediately with water.

Posology
Intramuscular use.
Bodyweight should be determined as accurately as possible to avoid underdosing.
For both cattle and sows when more than one injection is necessary on the same day because of the restriction of maximum dose volume, all the injections should be administered on the same side of the neck 15 cm apart. If it is necessary to repeat the injection after 24 hours all the injections should be given on the other side of the neck again 15 cm apart. This procedure is necessary so that individual injection sites are kept apart. Failure to follow these instructions may result in residues violations.

  • Cattle:

30 000 IU of spiramycin per kg bodyweight, i.e. 5 ml of product per 100 kg bodyweight. The injection may be repeated once after 24 hours. Do not administer more than 15 ml per injection site.

  • Sows:

75 000 IU of spiramycin per kg bodyweight, i.e. 5 ml of product per 40 kg bodyweight. The injection may be repeated once after 24 hours. Do not administer more than 7 ml per injection site.

Withdrawal period
Meat and offal:
Cattle: 52 days.
Pigs: 35days.
Milk: 10 days.

Storage
None.

Packaging
Box containing 1 glass vial of 50 ml
Box containing 1 glass vial of 100 ml
Box containing 1 glass vial of 250 ml
Box containing 1 plastic vial of 50 ml
Box containing 1 plastic vial of 100 ml
Box containing 1 plastic vial of 250 ml

From one country to another, product lines are adapted to local demand and regulatory requirements. For further information, please take a look at the CEVA Santé Animale site for your country. Warning: the information provided on the products depends on national registrations. Access to technical information is restricted to authorised persons.

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