Ülke: İspanya
Dil: İngilizce
Kaynak: HMA (Heads of Medicines Agencies)
doxycycline hyclate 10 %
S.P. Veterinaria S.A
QJ01AA02
Premix for medicated feed
doxycycline
Pigs Food
2011-09-23
B. PACKAGE LEAFLET PACKAGE LEAFLET ES : DOXI – 10 S.P. PREMIX BG, PL, RO : Doxi SP 100 mg/g premix for porcine 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT S.P VETERINARIA S.A. Ctra. Reus-Vinyols, km 4,1 43330 RIUDOMS TARRAGONA 2. NAME OF THE VETERINARY MEDICINAL PRODUCT ES : DOXI – 10 S.P. PREMIX BG, PL, RO : Doxi SP 100 mg/g premix for porcine 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER SUBSTANCES Doxycycline (hyclate) ...................... 100 mg/g 4. INDICATION(S) Porcine (fattening pigs): treatment of porcine respiratory complex caused _by _ _Pasteurella multocida, Bordetella bronchyseptica _ and/or _Mycoplasma _ _hyopneumoniae. _ For any infectious process a bacteriological confirmation of the diagnosis is recommended and a sensitivity test for the bacteria causing the process should be performed. 5. CONTRAINDICATIONS Do not administer to animals with known hypersensitivity to tetracyclines. Do not administer to animals with hepatic disturbances. Do not use in case of known resistance to tetracyclines 6. ADVERSE REACTIONS - As for all tetracyclines, photosensitization as well as allergic reactions may occur. - Prolonged treatments can lead to digestive disturbances and intestinal disbiosis. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. 7. TARGET SPECIES Porcine (fattening pigs) 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION In-feed use Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS (SPC) 1. NAME OF THE VETERINARY MEDICINAL PRODUCT. ES : DOXI – 10 S.P. PREMIX BG, PL, RO : Doxi SP 100 mg/g premix for porcine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION. ACTIVE SUBSTANCE Doxycycline (hyclate) .......................... 100 mg/g. EXCIPIENTS For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM. Premix for medicated feeding stuff 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Porcine (fattening pigs) 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Porcine (fattening pigs): treatment of porcine respiratory complex caused _by Pasteurella _ _multocida, Bordetella bronchyseptica _and/or _Mycoplasma hyopneumoniae. _ For any infectious process a bacteriological confirmation of the diagnosis is recommended and a sensitivity test for the bacteria causing the process should be performed. 4.3. CONTRAINDICATIONS Do not administer to animals with known hypersensitivity to tetracyclines. Do not administer to animals with hepatic disturbances. Do not use in case of known resistance to tetracyclines 4.4. SPECIAL WARNINGS Sick animals may have reduced appetite if necessary be medicated parenterally 4.5. SPECIAL PRECAUTIONS FOR USE I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS For any infectious process a bacteriological confirmation of the diagnosis is recommended and a sensitivity test for the bacteria causing the process should be performed. II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS. People with known hypersensitivity to te Belgenin tamamını okuyun