ZUPREVO 40 MGML VETERINARY

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

TILDIPIROSIN

Tilgjengelig fra:

INTERVET ( ISRAEL) LTD

Legemiddelform:

SOLUTION FOR INJECTION

Sammensetning:

TILDIPIROSIN 40 MG/ML

Administreringsrute:

I.M

Resept typen:

Required

Produsert av:

INTERVET INTERNATIONAL GmbH, GERMANY

Indikasjoner:

Treatment and Prevention of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica and Haemophilus parasuis sensitive to tildipirosim .The presence of the disease in herd should be established before preventive treatment.

Autorisasjon dato:

2021-04-30

Informasjon til brukeren

The format of this leaflet was determined by the Ministry of Health
and its contents checked and approved in May 2016
CONSUMER PACKAGE INSERT FOR A VETERINARY PREPARATION
The medicine is only dispensed with a veterinarian’s prescription
For veterinary use only
1. ZUPREVO 40 MG/ML VETERINARY
SOLUTION FOR INTRAMUSCULAR INJECTION FOR PIGS
2. COMPOSITION:
Each 1 ml contains:
Active ingredient:
Tildipirosin 40 mg
A detailed list of inactive ingredients can be found in the section
“Further Information”.
3. WHAT IS THE MEDICINE INTENDED FOR:
For treatment and prevention of swine respiratory disease (SRD)
associated with the
causative:
_Actinobacillus pleuropneumonia_, _Pasteurella multocida_,_ Bordetella
bronchiseptica_ and
_Haemophilus parasuis,_ which are sensitive to tildipirosin.
The presence of the disease in the herd must be confirmed before
prophylactic
treatment.
Therapeutic group:
Macrolide antibacterials for systemic use.
4. CONTRAINDICATIONS:
Do not use in the case of known sensitivity to macrolide antibiotics
or to any of the
inactive ingredients.
Do not administer intravenously in swine.
5. ADVERSE REACTIONS:
The frequency of adverse reactions is defined as follows:
• Very common (more than 1/10 animals displaying adverse reactions
during the course of
one treatment)
• Common (more than 1/100 but less than 10/100 animals displaying
adverse reactions
during the course of one treatment)
• Uncommon (more than 1/1,000 but less than 10/1,000 animals
displaying adverse
reactions during the course of one treatment)
• Rare (more than 1/10,000 but less than 10/10,000 animals
displaying adverse reactions
during the course of one treatment)
• Very rare (less than 1/10,000 animals, including isolated
incidences)
In very rare cases, severe allergic (shock) reactions with a
potentially fatal outcome
might occur.
In very rare cases, transient sleepiness, lethargy in piglets has been
observed.
During clinical trials, pain at the injection site, as well as
swellings, were very common in
treated pigs. The swe

Preparatomtale

This leaflet format has been determined by the Ministry of Health and
the content
thereof has been checked and approved
on
May 2016
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Zuprevo 40 mg/ml Veterinary
Solution for injection for pigs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
Active substance:
Tildipirosin 40 mg.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
Clear yellowish solution.
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment and prevention of swine respiratory disease (SRD) associated
with Actinobacillus
pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica and
Haemophilus parasuis
sensitive to tildipirosin.
The presence of the disease in the herd should be confirmed before
preventive treatment.
4.3 CONTRAINDICATIONS
Do not use in case of hypersensitivity to macrolide antibiotics or to
any of the excipients.
Do not administer intravenously.
4.4 SPECIAL WARNINGS
In line with responsible use principles, metaphylactic use of Zuprevo
is only indicated in severe
outbreaks of SRD caused by the indicated pathogens. Metaphylaxis
implies that clinically healthy
animals in close contact with diseased animals are administered the
product at the same time as
the treatment of the clinically diseased animals, to reduce the risk
for development of clinical
signs.
The efficacy of metaphylactic use of Zuprevo was demonstrated in a
placebo controlled multi-
centre field study, when outbreak of clinical disease was confirmed
(i.e. animals in at least 30%
of the pens sharing the same airspace showed clinical signs of SRD,
including at least 10%
animals per pen within 1 day; or 20% within 2 days or 30% within 3
days). Following etaphylactic
use, approximately 86% of the healthy animals remained free of
clinical signs of disease (as
compared to approximately 65% of animals in the untreated control
group).
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Wheneve