https___en.fmpharm.co.rs__D0_BF_D1_80_D0_BE_D0_B8_D0_B7_D0_B2_D0_BE_D0_B4_neomarboflox_.xml
http___fmpharm.co.rs_proizvod_veterinarski-lekovi-neomarboflox__1.xml
1.1 2.1 3.1 4.1 5.1 6.1 7.1 8.1 9.1 10.1 11.1 12.1 13.1 13.2 14.1 15.1 16.1 17.1 18.1 19.1 20.1 21.1 22.1 23.1 24.1 25.1 26.1 27.1 28.1 29.1 30.1 31.1 32.1 33.1 34.1 35.1 36.1 37.1 38.1 39.1 40.1 41.1 42.1 43.1 44.1 45.1 46.1 47.1 47.2 47.3 48.1 49.1 50.1 51.1 51.2 52.1 53.1 53.2 53.3 53.4 54.1 55.1 55.2 56.1 57.1 58.1 59.1 60.1 60.2 61.1 62.1
Description NEOMARBOFLOXACIN (CURRENTLY IN REGISTRATION PROCESS) COMPOSITION: Active substance Marbofloxacin 100 miligrams Excipients: Monothioglycerol Metacresol Disodium edetate Glucanolactone Water for injection INDICATION In cattle: Therapeutic treatment of respiratory infections caused by sensitive strains of Pasteurella multocida, Mannheimia haemolytica and Histophilus somni. It is also indicated in the treatment of acute E. coli mastitis. In pigs: Indicated in the treatment of Metritis Mastitis Agalactia syndrome caused by susceptible strains of organisms. CONTRAINDICATION Do not use in animals with known hypersensitivity to fluoroquinolones. Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance). TARGET SPECIES Cattle and pigs DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Cattle For the treatment of acute E.coli mastite the recommended dosage is 2mg/kg/day (1ml/50kg) in a single daily injection by intramuscular, subcutaneous or intravenous routes during 3-5 days. For the treatment of respiratory infections caused by sensitive strains of Pasteurella multocida, Mannheimia haemolytica and Histophilus somni: 2mg/kg/day (1ml/50kg) or 8 mg/kg body weight i.e. 2 ml /25kg body weight in a single intramuscular injection If the volume to be injected is more than 20 ml, it should be divided between two or more injection sites. Swine Treatment of Metritis Mastitis Agalactia syndrome caused by susceptible strains of organisms: 2mg/kg/day (1ml/50kg) in a single daily injection by intramuscular routes during 3 days. ADVICE ON CORRECT ADMINISTRATION To avoid excessive broaching of the septum, the use of a draw-off needle is recommended. WITHDRAWAL PERIOD Cattle At dose of 2 mg/kg bw during 3 do 5 days (i.m., s.c., i.v.) Meat: 6 days Milk 36 hours At dose of 8 mg/kg bw once (i.m.) Meat: 3 days Milk 72 hours Pigs : 4 days SPECIAL STORAGE PRECAUTIONS Keep the bottle in the outer carton in order to protect from light. Do not store above 25°C. Keep out of the sight and reach of children. Shelf life after first opening the container: 28 days. SPECIAL WARNING(S) Special warnings for each target species 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. Whenever possible, fluoroquinolones should only be used based on susceptibility testing. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance. For Animal Treatment Only Official and local antimicrobial policies should be taken into account when the product is used. Special precautions for use in animals People with known hypersensitivity to fluoroquinolones should avoid using this product. Wash hands after use. Use during pregnancy/ lactation Laboratory studies in rats and rabbits have not produced any evidence of a teratogenic, embryotoxic or maternotoxic effect associated with the use of marbofloxacin. Safety of the product at 8 mg/kg has not been determined in pregnant cows or in suckling calves when used in cows. Use only accordingly to the benefit/risk assessment by the responsible veterinarian. Marbofloxacin may be used in pregnant and lactating cows and sows. Overdose (symptoms, emergency procedures, antidotes), if necessary No severe side-effects are to be expected at doses up to 3 or 5 times the recommended dose in cattle and pigs respectively. In particular, no lesions of the articular joints are encountered. Incompatibilites Do not mix with other medicinal products. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority. Nature and composition of packaging: Type II amber glass vials of 100 ml. The vials are closed with a bromobutyl stopper and an aluminum cap. Conditions or restrictions regarding supply and use: On veterinary prescription only. ATC-vet code: QJ01MA93
1.1 2.1 3.1 4.1 5.1 6.1 7.1 8.1 9.1 10.1 11.1 12.1 13.1 14.1 15.1 16.1 17.1 18.1 19.1 20.1 21.1 22.1 23.1 24.1 25.1 26.1 27.1 28.1 29.1 30.1 31.1 32.1 33.1 34.1 35.1 36.1 37.1 38.1 39.1 40.1 41.1 42.1 43.1 44.1 45.1 46.1 47.1 48.1 49.1 50.1 51.1 52.1 53.1 54.1 55.1 56.1 57.1 58.1 59.1 60.1 61.1 62.1 63.1 64.1 65.1 66.1 67.1 67.2 67.3 67.4 68.1 69.1 70.1 71.1 71.2 72.1 73.1 74.1 75.1 76.1 77.1 78.1 79.1
Description NEOMARBOFLOXACIN (U PROCESU REGISTRACIJE) KVALITATIVNI I KVANTITATIVNI SASTAV LEKA 1 ml rastvora za injekciju sadrži Aktivna supstanca: Marbofloksacin 100 miligrama Pomoćne supstance: Glukonolakton Dinatrijum edetat Metakrezol Monotioglicerol Voda za injekcije INDIKACIJE Kod goveda: – terapija respiratornih infekcija izazvanih osetljivim sojevima bakterija Pasteurella multocida, Mannheimia haemolytica, Histophilus somni i Mycoplasma bovis, – terapija akutnog mastitisa izazvanog bakterijom E.coli. Kod svinja: – terapija MMA sindroma (metritis-mastitis-agalakcija) izazvanog osetljivim sojevima mikroorganizama. KONTRAINDIKACIJE Lek ne treba primenjivati kod životinja sa poznatom preosetljivošću na fluorohinolone. Lek ne treba koristiti u slučajevima kada je izolovani patogen rezistentan na druge fluorohinolone (unakrsna rezistencija). CILJNE VRSTE ŽIVOTINJA Goveda i svinje DOZIRANJE I NAČIN PRIMENE Goveda: – terapija akutnog mastitisa prouzrokovanog E.coli: 2 mg/kg marbofloksacina, odnosno 1mL/50 kg t.m. leka NEOMARBOFLOX intramuskularno, subkutano ili intravenski, jedanput dnevno, tokom 3-5 dana. – terapija respiratornih infekcija izazvanih osetljivim sojevima bakterija Pasteurella multocida, Mannheimia haemolytica, Histophilus somni i Mycoplasma bovis – preporučuju se dva režima: 2 mg/kg marbofloksacina, odnosno 1mL/50 kg t.m. leka NEOMARBOFLOX , intramuskularno ili subkutano (prva injekcija može da se da i intravenskim putem), jedanput dnevno tokom 3 do 5 dana (terapija mikoplazmatske pneumonije), ili 8 mg/kg marbofloksacina, odnosno 2 mL/25 kg t.m. leka NEOMARBOFLOX jednokratno. Ako je zapremina koju treba ubrizgati veća od 20 mL, lek aplikovati na dva ili više mesta. Svinje: – terapija MMA sindroma (metritis-mastitis-agalakcija) izazvanog osetljivim sojevima mikroorganizama. 2 mg/kg marbofloksacina, odnosno 1 mL/50 kg leka NEOMARBOFLOX intramuskularno, jedanput dnevno, tokom 3 dana. Kod goveda i svinja najbolje je ubrizgavati injekciju u predelu vrata. Za pravilno doziranje leka, utvrditi tačnu telesnu masu životinje. KARENCA Goveda 2 mg/kg tokom 3 do 5 dana (i.m., s.c., i.v.) Meso i iznutrice: 6 dana Mleko: 36 časova 8 mg/kg, jednokratno (i.m.) Meso i iznutrice: 3 dana Mleko: 72 časa Svinje Meso i iznutrice: 4 dana POSEBNA UPOZORENJA ZA ČUVANJE LEKA Čuvati van domašaja dece Čuvati na temperaturi do 25°C, u originalnom pakovanju. Rok upotrebe: 2 godine Rok upotrebe posle otvaranja: 28 dana POSEBNA UPOZORENJA Za primenu na životinjama. Posebna upozorenja za svaku ciljnu vrstu Nema. Posebne mere opreza pri upotrebi leka kod životinja Prilikom upotrebe leka treba uzeti u obzir nacionalne smernice za primenu antibiotika. Fluorohinolone treba koristiti samo za lečenje onih bolesti za koje već postoje saznanja ili se očekuje da će slabije reagovati na druge klase antimikrobnih lekova. Uvek kada je to moguće, fluorohinolone treba davati samo na osnovu nalaza antibiograma. Upotreba leka koja nije u skladu sa uputstvom datim u Sažetku karakteristika leka i Uputstvu za lek može da dovede do povećanja zastupljenosti bakterija rezistentnih na fluorohinolone i da smanji efikasnost lečenja drugim hinolonima, zbog moguće ukrštene rezistencije. Posebne mere predostrožnosti za osobe koje daju veterinarski lek životinjama Osobe koje su preosetljive na fluorohinolone treba da izbegavaju kontakt sa ovim lekom. Ako lek dođe u dodir sa kožom ili očima, isperite ga sa dosta tekuće vode. Slučajno samoubrizgavanje injekcije može da prouzrokuje blagu iritaciju. Upotreba tokom graviditeta i laktacije Istraživanja na laboratorijskim životinjama (pacovi, zečevi) nisu dala dokaze o teratogenom, embriotoksičnom ili maternotoksičnom dejstvu povezanom sa primenom marbofloksacina. Marbofloksacin se može koristiti kod krmača i krava u periodu graviditeta ili laktacije kada se primenjuje u dozi od 2 mg/kg. Bezbednost ovog leka primenjenog u dozi od 8 mg/kg nije utvrđena kod gravidnih krava, kao ni kod teladi koja sisa. S obzirom na navedeno, lek treba koristiti samo u skladu sa procenom odgovornog veterinara o odnosu koristi i rizika. Interakcije Nisu poznate. Predoziranje Lek primenjen u dozi 3 puta većoj od preporučene, nije prouzrokovao znakove predoziranja. Znakovi predoziranja su akutni neurološki poremećaji koje treba lečiti simptomatski Inkompatibilnost U nedostatku studija inkompatibilnosti, ovaj veterinarski lek ne treba mešati sa drugim lekovima. POSEBNE PREDOSTROŽNOSTI KOD ODLAGANJA I UNIŠTAVANJA LEKA Neiskorišćen lek ili ostatak leka se uništavaju u skladu sa važećim propisima. Pakovanje: Bočica od tamnog stakla, zatvorena čepom od brombutila i aluminijumskim poklopcem, sa 100 ml rastvora za injekciju. Način izdavanja leka: Lek se može izdavati samo na recept veterinara ATC vet kod: QJ01MA93