https___en.fmpharm.co.rs__D0_BF_D1_80_D0_BE_D0_B8_D0_B7_D0_B2_D0_BE_D0_B4_neotulathromycin_.xml
http___fmpharm.co.rs_proizvod_veterinarski-lekovi-neotulathromycin__1.xml
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Description NEOTULATHROMYCIN (CURRENTLY IN REGISTRATION PROCESS) COMPOSITION: Active substance Tulathromycin 100 miligrams per mililitre Excipients: Monothioglycerol Propylene glycol Hydrochloric acid Sodium hydroxide Water for injection INDICATION Cattle Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis sensitive to tulathromycin. The presence of the disease in the herd should be established before metaphylactic treatment. Treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis sensitive to tulathromycin. Pigs Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica sensitive to tulathromycin. The presence of the disease in the herd should be established before metaphylactic treatment. TULATHROMYCIN should only be used if pigs are expected to develop the disease within 2–3 days. Sheep Treatment of the early stages of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus requiring systemic treatment. CONTRAINDICATION Do not use in case of hypersensitivity of the target animals to macrolide antibiotics. Do not use simultaneously with other macrolides or lincosamides (see section 4.8). Do not use in lactating animals producing milk for human consumption. Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition. TARGET SPECIES Cattle, pigs, and sheep DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Cattle (treatment and metaphylaxis) 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight). A single subcutaneous injection. For treatment of cattle over 300 kg bodyweight, divide the dose so that no more than 7.5 ml are injected at one site. Pigs 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight). A single intramuscular injection in the neck. For treatment of pigs over 80 kg bodyweight, divide the dose so that no more than 2 ml are injected at one site. Sheep 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight). A single intramuscular injection in the neck. ADVICE ON CORRECT ADMINISTRATION It is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment within 48 hours after injection. If clinical signs of respiratory disease persist or increase, or if relapse occurs, treatment should be changed, using another antibiotic, and continued until clinical signs have resolved. To ensure correct dosage bodyweight should be determined as accurately as possible to avoid underdosing. For multiple vial entry, an aspirating needle or multi-dose syringe is recommended to avoid excessive broaching of the stopper WITHDRAWAL PERIOD Cattle (meat and offal): 22 days. Pigs (meat and offal): 13 days. Sheep (meat and offal): 16 days. Not authorised for use in lactating animals producing milk for human consumption. Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition. 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 Special warnings for sheep: The efficacy of antimicrobial treatment of foot rot might be reduced by other factors, such as wet environmental conditions, as well as inappropriate farm management. Treatment of foot rot should therefore be undertaken along with other flock management tools, for example providing dry environment. 37 Antibiotic treatment of benign foot rot is not considered appropriate. Draxxin showed limited efficacy in sheep with severe clinical signs or chronic foot rot, and should therefore only be given at an early stage of foot rot. Special precautions for use in animals Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. Official, national and regional antimicrobial policies should be taken into account when the product is used. If a hypersensitivity reaction occurs appropriate treatment should be administered without delay. Use during pregnancy/ lactation Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Use only according to the benefit/risk assessment by the responsible veterinarian. Interaction with other medicinal products and other forms of interaction Do not administer simultaneously with antimicrobials with a similar mode of action such as other macrolides or lincosamides. Overdose (symptoms, emergency procedures, antidotes), if necessary In cattle at dosages of three, five or ten times the recommended dose, transient signs attributed to injection site discomfort were observed and included restlessness, head-shaking, pawing the ground, and brief decrease in feed intake. Mild myocardial degeneration has been observed in cattle receiving 5 to 6 times the recommended dose. In young pigs weighing approximately 10 kg given three or five times the therapeutic dose transient signs attributed to injection site discomfort were observed and included excessive vocalisation and restlessness. Lameness was also observed when the hind leg was used as the injection site. In lambs (approx. 6 weeks old), at dosages of three or five times the recommended dose, transient signs attributed to injection site discomfort were observed and included walking backwards, head shaking, rubbing the injection site, lying down and getting up, bleating. Special precautions to be taken by the person administering the veterinary medicinal product to animals Tulathromycin is irritating to eyes. In case of accidental eye exposure, flush the eyes immediately with clean water. Tulathromycin may cause sensitisation by skin contact. In case of accidental spillage onto skin, wash the skin immediately with soap and water. Wash hands after use. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Incompatibilites In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. Nature and composition of packaging: Type I glass vial with a fluoropolymer coated chlorobutyl stopper and an aluminium overseal. Conditions or restrictions regarding supply and use: On veterinary prescription only. ATC-vet code: QJ01FA94
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Description NEOTULATHROMYCIN KVALITATIVNI I KVANTITATIVNI SASTAV LEKA 1 ml rastvora za injekciju sadrži Aktivna supstanca: Tulatromicin 100 miligrama Pomoćne supstance: Monotioglicerol Propilen glikol Limunska kiselina Hlorovodonična kiselina Natrijum hidroksid Voda za injekcije INDIKACIJE Goveda Lečenje i metafilaksa respiratornih bolesti goveda uzrokovanih sa Manheimia (Pasteurella) haemolytica,Pasteurella multocida, Histophilius somni i Mycoplasma bovis osetljivim na tulatromicin. Potrebno je utvrditi postojanje oboljenja u zapatu pre početka preventivne terapije. Lečenje infektivnog bovinog keratokonjunktivitisa (IBK) uzrokovanih sa Moraxella bovis. Svinje Lečenje i metafilaksa respiratornih bolesti svinja uzrokovanih sa Actinobacillus pleuropneumoniae,Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis i Bordetella bronchiseptica osetljivim na tulatromicin. Potrebno je utvrditi postojanje oboljenja u zapatu pre početka preventivne terapije. Ovaj lek bi jedino trebalo koristiti ukoliko se kod svinja očekuje razvoj bolesti u toku 2-3 dana. Ovce Lečenje ranih faza infektivnog pododermatitisa (zarazne šepavosti) povezanog sa virulentnim Dichelobacter nodosus koji zahteva sistemsku terapiju. KONTRAINDIKACIJE Ne daje se životinjama preosetljivim na makrolidne antibiotike. Ne daje se istovremeno sa drugim antibioticima iz grupe makrolida i linkozamida. Ne daje se životinjama u laktaciji čije se mleko koristi u ishrani ljudi. Ne daje se gravidnim životinjama 2 meseca pre partusa ukoliko se njihovo mleko koristi u ishranu ljudi. CILJNE VRSTE ŽIVOTINJA Goveda, svinje i ovce. DOZIRANJE I NAČIN PRIMENE Goveda Subkutana primena. Jedna subkutana injekcija od 2.5 mg tulatromicina/kg telesne mase (ili 1 mL/40 kg telesne mase). Kod lečenja goveda telesne mase preko 300 kg, podelite dozu tako da se na jedno mesto ne ubrizgava više od 7.5 mL. Svinje Intramuskularna primena. Jedna intramuskularna injekcija od 2.5 mg tulatromicina/kg telesne mase (ili 1 mL/40 kg telesne mase) u vrat. Kod lečenja svinja telesne mase preko 80 kg, podelite dozu tako da se na jedno mesto ne ubrizgava više od 2 mL. Kada su u pitanju respiratorne bolesti, savetuje se lečenje životinja u ranom stadijumu oboljenja i procena terapije u roku od 48 sati nakon injekcije. Ako se klinički znaci respiratorne bolesti nastave ili ako se pogoršaju, ili ako dođe do relapsa, terapiju treba izmeniti, koristiti drugi antibiotik i davati ga dok se klinički znaci ne povuku. Ovce Intramuskularna primena. Jedna intramuskularna injekcija od 2.5 mg tulatromicina/kg telesne mase (ili 1 mL/40 kg telesne mase) u vrat. UPUTSTVO ZA PRAVILNU UPOTREBU LEKA Da bi se obezbedila tačna doza, telesnu masu treba utvrditi što je tačnije moguće kako bi se izbeglo davanje premalih doza. Kada lečite više životinja istovremeno lekom iz jedne multidozne bočice, koristite iglu za izvlačenje postavljenu u zapušač bočice da bi se izbeglo prekomerno probadanje zapušača. Iglu za izvlačenje uklonite nakon terapije. KARENCA Goveda (meso i iznutrice): 22 dana Svinje (meso i iznutrice): 13 dana Ovce (meso i iznutrice): 16 dana Ne daje se životinjama u laktaciji čije se mleko koristi u ishrani ljudi. Ne daje se gravidnim životinjama 2 meseca pre partusa ukoliko se njihovo mleko koristi u ishrani ljudi. 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 Posebne mere predostrožnosti za osobe koje daju veterinarski lek životinjama Nema posebnih upozorenja. Posebna upozorenja za svaku ciljnu vrstu Efikasnost antimikrobnog lečenja zarazne šepavosti kod ovaca može biti umanjena pod uticajem određenih faktora, koji uključuju pre svega visok procenat vlage i loše higijenske uslove. Zbog toga, lečenje treba sprovoditi zajedno sa poboljšanjem uslova držanja i nege životinja. Smanjena efikasnost leka je zabeležena i u slučajevima pojave težih simptoma zarazne šepavosti kod ovaca, kao i kod hroničnog toka bolesti, tako da se primena leka preporučuje samo u ranoj fazi. Upotreba tokom graviditeta i laktacije Laboratorijska ispitivanja na pacovima i kunićima nisu pokazala teratogene, fetotoksične ili maternotoksične efekte. Bezbedna primena tulatromicina tokom graviditeta i laktacije još uvek nije dokazana kod goveda i svinja. U ovim slučajevima lek se može primeniti jedino na osnovu procena bezbednosti i rizika ordinirajućeg veterinara. Interakcije Javlja se ukrštena rezistencija sa ostalim makrolidima. Ne davati istovremeno sa antiinfektivima koji imaju sličan način delovanja, poput drugih makrolida ili linkozamida. Predoziranje Kod goveda 3, 5 ili 10 puta veća doza od preporučene dovodi do prolaznih promena na mestu aplikacije, nelagodnosti koja se manifestuje mahanjem glavom, udaranjem nogom o zemlju i privremenim gubitkom apetita. Blaga degeneracija miokarda je primećena kod goveda koja su primila 5 do 6 puta veću dozu od preporučene. Kod prasadi telesne mase oko 10 kg koja su dobila 3 do 5 puta veću dozu od propisane dolazi do prolaznih promena na mestu aplikacije i nemira životinje. Takođe je primećeno hramanje životinje kad je lek aplikovan u zadnju nogu. Kod jagnjadi starosti oko 6 nedelja, 3 i 5 puta veća doza od preporučene dovodi do pojave prolaznih promena koje se manifestuju u vidu nelagodnosti (hodanje unazad, otresanje glavom, trljanje mesta aplikacije leka, ležanje i ustajanje, blejanje). Inkompatibilnost U odsustvu ispitivanja kompatibilnosti, ovaj veterinarski lek se ne sme 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 50ml i 100 ml rastvora za injekciju. Način izdavanja leka: Lek se može izdavati samo na recept veterinara ATC vet kod: QJ01FA94