ZUPREVO BOVINE 250ML

TECHNICAL SHEET OR SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT
ZUPREVO 40 mg/ml solution for injection for pigs

For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Injectable solution.
Clear yellowish solution.
4. CLINICAL DATA
4.1 Target species
Porcine
4.2 Indications for use, specifying the target species
Treatment and metaphylaxis of swine respiratory disease (PRD) associated with Actinobacillus
pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica y Haemophilus parasuis
sensitive to tildipirosin.
The presence of the disease in the herd must be confirmed before implementing metaphylaxis.
4.3 Contraindications
Do not use in case of hypersensitivity to macrolide antibiotics or to any of the excipients.
Do not administer intravenously.
Do not use simultaneously with other macrolides or lincosamides (see section 4.8).
4.4 Special warnings
In line with the principles of responsible use, metaphylactic treatment with Zuprevo is
Only indicated in serious outbreaks of SRD produced by the indicated pathogens. metaphylaxis
implies that clinically healthy animals in direct contact with sick animals are given
administers the veterinary medicinal product at the same time as animals are treated clinically
sick, to reduce the risk of developing clinical symptoms.
The efficacy of metaphylaxis with the use of Zuprevo has been demonstrated in a field study.
placebo-controlled multicenter, when clinical disease flare was confirmed (i.e.,
animals in at least 30% of the pens sharing the same space showed signs
clinical SRD, including at least 10% animals per pen in 1 day; or 20% in 2 days or
30% in 3 days. After metaphylactic treatment, approximately 86% of healthy animals
remained without clinical symptoms of disease (compared to approximately 65% ​​of
animals in the control group).
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4.5 Special precautions for use
Special precautions for use in animals
Whenever possible, the use of the antimicrobial should be based on susceptibility testing.
When using this medication, official recommendations should be taken into account.
(national or regional) on the use of antimicrobials.
Administer only intramuscularly. Special attention should be paid to use the place of
proper injection as well as using the proper size and length of needle (adapted to the size and
animal weight) according to good veterinary practice.
Special precautions to be taken by the person administering the veterinary medicinal product to
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Special care should be taken to avoid accidental self-injection, since toxicological studies
in laboratory animals showed cardiovascular effects after administration
intramuscular injection of tildipirosin. In case of accidental self-injection, consult a doctor
immediately and show him the package insert or label.
Do not use with automatic syringes that do not have an additional protection system.
Tildipirosin may cause sensitization by skin contact. If there were a
Accidental skin exposure, wash skin immediately with soap and water. If there were a
Accidental eye exposure, immediately flush eyes with clean water.
Wash hands after use.
4.6 Adverse reactions (frequency and seriousness)
In very rare cases individual shock reactions could occur with a potential
fatal outcome.
On very rare occasions, transient lethargy has been observed in piglets.
In safety studies in the target species, administration of the maximum volume
recommended injection (5 ml) very frequently produced slight inflammations at the injection site.
injection that were not tender on palpation. The inflammations persisted up to 3 days. The
pathomorphological reactions at the injection site completely resolved in 21 days.
During clinical tests, painful injection and inflammation were observed very frequently in
injection site in treated pigs. These inflammations resolved in 1 to 6 days.
The frequency of adverse reactions is defined using the following convention:
• Very common (more than 1 animal in 10 shows adverse reactions during the
course of treatment)
• Common (more than 1 but less than 10 animals out of 100 animals)
• Infrequent (more than 1 but less than 10 animals out of 1.000 animals)
• Rare (more than 1 but less than 10 animals out of 10.000 animals)
• Very rare (less than 1 in 10.000 animals, including isolated cases)
4.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy or
lactation. However, there was no evidence of any selective effect on reproduction or development.
development in any of the laboratory studies.
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Use only in accordance with the benefit-risk assessment by the veterinarian
responsible.

See technical sheet