국가: 이스라엘
언어: 영어
출처: Ministry of Health
TILDIPIROSIN
INTERVET ( ISRAEL) LTD
SOLUTION FOR INJECTION
TILDIPIROSIN 40 MG/ML
I.M
Required
INTERVET INTERNATIONAL GmbH, GERMANY
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.
2021-04-30
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 전체 문서 읽기
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 전체 문서 읽기