Country: Israel
Bahasa: Inggeris
Sumber: Ministry of Health
ENROFLOXACIN
LIDORR ELEMENTS LTD
SOLUTION FOR INJECTION
ENROFLOXACIN 50 MG/ML
S.C
Required
BAYER ANIMAL HEALTH GmbH, GERMANY
In calves:Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurellamultocida, Mannheimia haemolytica and Mycoplasma spp.Treatment of infections of the alimentary tract caused by enrofloxacin susceptible strains of Escherichia coli.Treatment of septicaemia caused by enrofloxacin susceptible strains of Escherichia coli.Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis.only after the sensitivity of the bacteria has been proven and it has been found that there is no alternative treatment (proven resistance to other agents).
2022-06-30
CONSUMER LEAFLET FOR A VETERINARY PRODUCT This medicine is marketed according to a veterinarian’s prescription only. For animal use only 1. NAME OF THE VETERINARY MEDICINE, FORM AND STRENGTH Baytril 5%, injectable solution veterinary 2. ACTIVE INGREDIENTS and quantity in a single dose: Enrofloxacin 50 mg/ml Excipients: Butyl alcohol: 30 mg/ml. For the full list of excipients, see section 13 in this leaflet. 3. WHAT IS THE MEDICINE INTENDED FOR IN CALVES: Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurella multocida, Mannheimia haemolytica and Mycoplasma spp. Treatment of infections of the alimentary tract caused by enrofloxacin susceptible strains of Escherichia coli. Treatment of septicaemia caused by enrofloxacin susceptible strains of Escherichia coli. Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis. Only after the sensitivity of the bacteria has been proven and it has been found that there is no alternative treatment (proven resistance to other agents). Therapeutic group: Fluoroquinolone antibiotic for systemic use. 4. CONTRA-INDICATIONS Do not use in animals with known hypersensitivity to enrofloxacin or other fluoroquinolones or to any of the excipients. Do not use in animals that are epileptic or suffer from seizures since enrofloxacin may cause Central Nervous System stimulation. 5. SIDE EFFECTS In very rare cases (less than 1 in 10,000 animals) Digestive tract disorders (e.g. diarrhoea) may occur. These signs are generally mild and transient. In very rare cases (less than 1 in 10,000 animals), transient local tissue injection site reactions may occur, and may be observed up to 14 days. Side effects can be reported to the Ministry of Health by clicking on the link "Adverse Drug Reactions Report" that appears on the home page of the Ministry of Health web site (www.health.gov.il), which leads to an online form for reporting side effects. Alternatively you can use the following link: https Baca dokumen lengkap
Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT BAYTRIL 5% INJECTABLE SOLUTION VETERINARY 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains: ACTIVE SUBSTANCE: Enrofloxacin: 50 mg EXCIPIENT: Butyl alcohol:30 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear light-yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (calves) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES CALVES Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of _Pasteurella multocida, Mannheimia haemolytica _and _Mycoplasma _spp. Treatment of infections of the alimentary tract caused by enrofloxacin susceptible strains of _Escherichia coli_. Treatment of septicaemia caused by enrofloxacin susceptible strains of _Escherichia coli_. Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of _Mycoplasma bovis_ _Only after the sensitivity of the bacteria has been proven and it has been _ _found that there is no alternative treatment (proven resistance to other _ _agents). _ _ _ Page 2 of 8 _ _ 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to enrofloxacin or other fluoroquinolones or to any of the excipients listed in section 6.1. Do not use in animals that are epileptic or suffer from seizures since enrofloxacin may cause CNS stimulation. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE i) Special precautions for use in animals Official and local antimicrobial policies should be taken into account when the product is used. Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials. fluoroquinolones should only be used based on susceptibility testing. Use of the product including use deviating from the instructions given in the SPC may increase the prevalence of b Baca dokumen lengkap