https___en.fmpharm.co.rs__D0_BF_D1_80_D0_BE_D0_B8_D0_B7_D0_B2_D0_BE_D0_B4_neoflunixin_.xml
http___fmpharm.co.rs_proizvod_veterinarski-lekovi-neoprofen__1.xml
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Description NEOFLUNIXIN (CURRENTLY IN REGISTRATION PROCESS) COMPOSITION: Active substance Flunixin 50 miligrams Excipients: Phenol Sodium formaldehyde sulfoxylate Propylene glycol Disodium edetate Trisodium phosphate dodecahydrate Sodium hydroxide Water for injection INDICATION In Cattle: For the control of acute inflammation associated with respiratory disease. NEOFLUNIXIN has also been shown to have some benefit in the treatment of experimental acute bovine pulmonary emphysema (Fog Fever). NEOFLUNIXIN may be used as adjunctive therapy in the treatment of acute mastitis. In Horses: For the alleviation of inflammation and pain associated with musculo-skeletal disorders. For the alleviation of visceral pain associated with colic in the horse. In Pigs: For use as an adjunctive therapy in the treatment of swine respiratory diseases. CONTRAINDICATION Do not exceed the stated dose or the duration of treatment. Use is contra-indicated in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of gastro-intestinal ulceration or bleeding, or where there is hypersensitivity to the product. Do not use the product within 48 hours before expected parturition in cows. Do not administer to pregnant mares. Do not administer to pregnant sows, gilts at mating and in breeding boars. TARGET SPECIES Cattle, horses and pigs DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Cattle 2ml per 45kg bodyweight (equivalent to 2.2mg flunixin per kg) administered intravenously. Repeat as necessary at 24 hour intervals for up to 5 consecutive days. Horses By intravenous injection for musculo-skeletal disorders at the following rate: 1ml per 45kg bodyweight (1.1mg flunixin/kg) once daily for up to 5 days according to clinical response. By intravenous injection for colic at the following rate: 1ml per 45kg bodyweight (1.1 mg flunixin/kg) repeated once or twice if colic recurs. For the treatment of endotoxaemia or septic shock associated with gastric torsion and with other conditions in which the circulation of blood to the gastro-intestinal tract is compromised: 0.25mg/kg every 6-8 hours, by intravenous injection. Pigs 2 ml per 45 kg bodyweight (equivalent to 2.2 mg flunixin/kg) once by intramuscular injection, in the neck, in conjunction with appropriate antimicrobial therapy. The injection volume should be limited to a maximum of 5 ml per injection site. An appropriately graduated syringe must be used to allow accurate administration of the required dose volume. This is particularly important when injecting small volumes. When intramuscular injection is used, the dose should be divided between two injection sites on either side of the neck. In order to prevent excessive broaching of the rubber stopper, it is not recommended that the stopper is broached more than 25 times. ADVICE ON CORRECT ADMINISTRATION In order to prevent excessive broaching of the rubber stopper, it is not recommended that the stopper is broached more than 25 times. WITHDRAWAL PERIOD Animals must not be slaughtered for human consumption during treatment. Cattle: 5 days from the last treatment. Horses: 7 days from the last treatment. Pigs: 22 days from the last treatment. Milk for human consumption must not be taken during treatment. Milk for human consumption may only be taken from cattle after 24 hours from the last treatment. SPECIAL STORAGE PRECAUTIONS Keep out of the reach and sight of children. Do not store above 25°C. Do not freeze. Shelf-life of the veterinary medicinal product as packaged for sale: 2 years. Shelf-life after first broaching the immediate packaging: 28 days. SPECIAL WARNING(S) Special precautions for use in animals Non-steroidal, anti-inflammatory drugs are not permitted under the rules of Racing and under rules covering other competitive events. These drugs should be discontinued at least 8 days before the competition. Avoid intra-arterial injection. NSAIDS are known to have the potential to delay parturition through a tocolytic effect by inhibiting prostaglandins that are important in signalling the initiation of parturition. The use of the product in the immediate post-partum period may interfere with uterine involution and expulsion of foetal membranes resulting in retained placentae. See also section “Use during pregnancy and lactation”. Use in any animal less than 6 weeks of age or in aged animals may involve additional risk. If such use cannot be avoided animals may require a reduced dosage and careful clinical management. Do not use in hypovolaemic animals except in the case of endotoxaemia or septic shock. It is preferable that NSAIDs which inhibit prostaglandin synthesis are not administered to animals undergoing general anaesthesia until fully recovered. The cause of colic should be determined and treated with concurrent therapy. The product should not be used in piglets weighing less than 6 kg. Use during pregnancy/ lactation The product may be used in pregnant and lactating cattle. The product should only be administered within the first 36 hours post-partum following a benefit/risk assessment performed by the responsible veterinarian and treated animals should be monitored for retained placentae. Do not use in pregnant mares or pregnant sows. Safety studies in pregnant mares and pregnant sows have not been conducted. Interaction with other medicinal products and other forms of interaction Do not administer other NSAIDs concurrently or within 24 hours of each other. Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs which can lead to toxic effects. Concurrent administration of potentially nephrotoxic drugs should be avoided. Overdose (symptoms, emergency procedures, antidotes), if necessary Overdosage studies in the target species have shown the product to be well-tolerated. Flunixin meglumine is a non-steroidal anti-inflammatory drug. Overdosage is associated with gastrointestinal toxicity. Concurrent use of nephrotoxic drugs should be avoided. Incompatibilites Do not administer other NSAIDs concurrently or within 24 hours of each other. Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs which can lead to toxic effects. Concurrent administration of potential nephrotoxic drugs should be avoided. 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 II 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: QM01AG90
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Description NEOPROFEN (U PROCESU REGISTRACIJE) KVALITATIVNI I KVANTITATIVNI SASTAV LEKA 1 ml rastvora za injekciju sadrži Aktivna supstanca: Ketoprofen 100 miligrama Pomoćne supstance: Benzil alkohol Arginin Limunska kiselina Voda za injekcije INDIKACIJE Konji – Ublažavanje upale i bola kod mišićno-koštanih poremećaja. – Ublažavanje viscelarnog bola kod kolika. Goveda – Potporna terapija puerperalne pareze. – Terapija hipertermije u toku bakterijskih infekcija respiratornog trakta zajedno sa odgovarajućom antimikrobnom terapijom. – Potporna terapija akutnih kliničkih mastita, uključujući i endotoksične mastitise u kombinaciji sa antimikrobnim lekovima. – Ublažavanje bola i edema vimena nakon telenja. – Za ublažavanje bola kod hromosti. Svinje – Ublažavanje hiperpireksije i respiratornih poremećaja kod bakterijskih ili virusnih infekcija respiratornog sistema, zajedno sa antimikrobnom terapijom. – Potporna terapija MMA sindroma zajedno sa odgovarajućim antimikrobnim lekovima. KONTRAINDIKACIJE Ne koristiti kod životinja kod kojih postoji poznata preosetljivost na aktivnu supstancu ili na neku od pomoćnih supstanci. Ne davati druge nesteroidne anti-inflamatorne lekove (NSAIL) istovremeno ili u roku od 24 časa u odnosu na drugi, kortikosteroide, diuretike i antikoagulanse. Lek se ne koristi kod životinja sa poremećajima rada srca, jetre i bubrega, gde postoji mogućnost gastro-intestinalnih ulceracija ili krvarenja, ili gde postoji dokaz krvne diskrazije. Lek ne primenjivati kod kobila u graviditetu. CILJNE VRSTE ŽIVOTINJA Konji, goveda i svinje DOZIRANJE I NAČIN PRIMENE Lek se aplikuje životinjama intravenski ili duboko intramuskularno u sledećim dozama: Konji: – Poremećaj mišićno-koštanog sistema 1 ml/45 kg t.m. ili 5,5 ml/250 kg t.m./dan (ekv. 2,2 mg ketoprofena/ kg t.m.), i.v., u toku 3-5 dana – Kolike 1 ml/45 kg t.m. ili 5,5 ml/250 kg t.m. ( ekv. 2,2 mg ketoprofena/ kg t.m.), jednokratno, i.v.. U slučaju potrebe aplikacija leka se može ponoviti. Goveda: 1 ml/33 kg t.m. ili 3 ml/100 kg t.m./dan (ekv. 3 mg ketoprofena/ kg t.m.), i.v. ili i.m., u toku 3 dana. Svinje: 1 ml/33 kg t.m. ili 3 ml/100 kg t.m./dan ( ekv.3 mg ketoprofena/kg t.m.) jednokratno, i.m. KARENCA Goveda: Meso 4 dana. Mleko nema ograničenja. Svinje: Meso 4 dana. Konji: Ne koristiti kod životinja namenjenih ljudskoj ishrani POSEBNA UPOZORENJA ZA ČUVANJE LEKA Čuvati van domašaja dece Čuvati na temperaturi do 30°C, u originalnom pakovanju. Rok upotrebe: 2 godine Rok upotrebe posle otvaranja: 28 dana POSEBNA UPOZORENJA Za primenu na životinjama. Primena kod životinja mlađih od 6 nedelja ili starih životinja nosi dodatne rizike. Ove životinje treba pažljivo klinički tretirati ukoliko se takva primena ne može izbeći. Izbegavajte upotrebu kod dehidriranih, hipovolemičnih ili hipotenzivnih životinja, zbog mogućeg rizika od povišene renalne toksičnosti. Posebna upozorenja za svaku ciljnu vrstu Nema. Posebne mere opreza pri upotrebi leka kod životinja U nedostatku podataka o specifičnoj toleranciji za veoma mladu ždrebad, upotreba preparata se ne preporučuje kod ždrebadi mlađe od 15 dana starosti. Ne primenjivati intraarterijski. Nemojte prekoračiti preporučenu dozu ni trajanje terapije. Posebne mere predostrožnosti za osobe koje daju veterinarski lek životinjama U slučaju samoubrizgavanja zatražite medicinsku pomoć. Nakon upotrebe oprati ruke. Izbegavajte kontakt sa očima. Ukoliko je potrebno isperite većom količinom vode. Ne koristiti kod gravidnih kobila. Lek se primenjuje kod gravidnih i krava u laktaciji. Lek se primenjuje kod krmača u laktaciji. Ne primenjivati istovremeno sa drugim nestereoidnim antiinflamatornim lekovima (NSAIL) ili u roku od 24 časa od njihove primene. Ne primenjivati istovremeno sa diureticima ili antikoagulansima. Treba izbegavati istovremenu primenu potencijalno nefrotoksičnih lekova (kao što su aminoglikozidni antibiotici). 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: Unutrašnje pakovanje: bočica od tamnog stakla (tip II), sa 100 mL rastvora za injekcije, zatvorena gumenim čepom i aluminijumskom kapicom. Spoljnje pakovanje: složiva kartonska kutija u kojoj se nalazi 1 bočica sa 100 mL rastvora za injekciju i Uputstvo za lek. Način izdavanja leka: Lek se može izdavati samo na recept veterinara ATC vet kod: QM01AE03