natgillin/translations-raw huggingface dataset:
In dog studies, tilmicosin induced a negative inotropic effect with consequent tachycardia, and a reduction in systemic arterial blood pressure and arterial pulse pressure.
V študijah na psih je tilmikozin induciral negativni inotropni učinek s posledično tahikardijo ter znižanje sistemskega arterijskega krvnega tlaka in arterijskega pulznega tlaka.
Do not inject more than 20 ml per injection site.
V eno mesto injiciranja ne injicirajte več kot 20 ml.
Pharmacokinetic studies demonstrate that concentrations of tilmicosin in the lung can exceed 2 µg/ml for more than 3 days which would be therapeutic for M. haemolytica, Trueperella pyogenes (formerly known as Actinomyces pyogenes), Staphylococcus aureus and Mycoplasma ovipneumonia according to in vitro studies conducted in 1992.
Farmakokinetične študije kažejo, da lahko koncentracije tilmikozina v pljučih presežejo 2 µg/ml za več kot 3 dni, kar je v skladu z in vitro študijami iz leta 1992 terapevtsko za bakterije M. haemolytica, Trueperella pyogenes (prej znano kot Actinomyces pyogenes), Staphylococcus aureus in Mycoplasma ovipneumonia.
Meat and offal: 42 days Milk: 18 days
Meso in drobovina: 42 dni Mleko: 18 dni
Since the MIC values of M. haemolytica tended to increase over the last decade the MIC90 data from recently isolated European strains should be included in SPC section 5.1 Pharmacodynamic properties.
Ker so se vrednosti MIK za bakterijo M. haemolytica v zadnjem desetletju običajno višale, je treba v poglavje 5.1 Farmakodinamične lastnosti v povzetku glavnih značilnosti zdravila vključiti podatek MIK90 iz nedavno izoliranih evropskih sevov.
The recommended dose rate of 5 to 10 mg/kg body weight seems justified based on the available data, however pharmacokinetic studies combined with in vitro MIC studies imply that a dose of 10 mg/kg body weight would be preferable for curing the major pathogens in interdigital necrobacillosis in cattle.
Priporočeni odmerek od 5 do 10 mg/kg telesne mase se zdi upravičen na osnovi razpoložljivih podatkov, vendar farmakokinetične študije skupaj z in vitro študijami MIK nakazujejo, da bi bilo za zdravljenje pomembnejših patogenov pri interdigitalni nekrobacilozi pri govedu bolje uporabiti odmerek 10 mg/kg telesne mase.
In pigs, intramuscular injection at 20 mg/kg body weight has caused deaths.
Pri prašičih je intramuskularno injiciranje odmerka 20 mg/kg telesne mase povzročilo smrt.
Bacteriology from nasal swabs and lung tissues in these studies revealed M. haemolytica and P. multocida as major causes of pneumonia in calves.
Bakteriologija brisov iz nosu in pljučnih tkiv v teh študijah je pokazala, da sta bakteriji M. haemolytica in P. multocida glavni vzrok pljučnice pri govedu.
Meat and offal: 70 days Milk: 36 days
Meso in drobovina: 70 dni Mleko: 36 dni
TARGET SPECIES Cattle and sheep.
CILJNE ŽIVALSKE VRSTE Govedo in ovce
DO NOT GIVE ADRENALIN OR BETA-ADRENERGIC ANTAGONISTS SUCH AS PROPRANOLOL.
NE UPORABLJAJTE ADRENALINA ALI ANTAGONISTA BETA
This antibacterial activity is predominantly against Gram-positive microorganism with activity against certain Gram-negative ones and Mycoplasma of a bovine and ovine origin.
Antibakterijsko je dejaven predvsem proti grampozitivnim mikroorganizmom in proti nekaterim gramnegativnim mikroorganizmom ter mikoplazmi govejega in ovčjega izvora.
A rabbit doe of 5 kg body weight would require a dose of 0.1 ml of product and a growing rabbit a volume around 0.05 ml.
Za kunca s telesno maso 5 kg bi bil odmerek zdravila 0,1 ml, za kunca v rasti pa bi bil volumen približno 0,05 ml.
Numerous studies revealed that 10 mg tilmicosin/kg body weight is effective against respiratory disease due to M. haemolytica and P. multocida in cattle and sheep.
V številnih študijah so ugotovili, da je odmerek 10 mg tilmikozina/kg telesne mase učinkovit proti boleznim dihal zaradi bakterij M. haemolytica in P. multocida pri govedu in ovcah.
INJECTION OF TILMICOSIN IN HUMANS CAN BE FATAL - EXERCISE EXTREME CAUTION TO AVOID ACCIDENTAL SELF-INJECTION AND FOLLOW THE ADMINISTRATION INSTRUCTIONS AND THE GUIDANCE BELOW, PRECISELY
PRI LJUDEH LAHKO INJICIRANJE TILMIKOZINA POVZROČI SMRT - BODITE IZJEMNO PREVIDNI, DA PREPREČITE NENAMERNO SAMOINJICIRANJE, TER
The Committee considered that the proposed indication “treatment of respiratory tract infections caused by M. haemolytica and P. multocida” had been sufficiently substantiated by data.
Odbor je menil, da je predlagana indikacija „zdravljenja okužb dihalnih poti, ki jih povzročata bakteriji M. haemolytica in P. multocida“, zadostno utemeljena s podatki.
Further to the assessment of the above mentioned data and the serious concerns expressed by the CVMP about the use of the product in the target species rabbits the MAHs agreed to remove all references to rabbits from the product information.
Glede na oceno zgoraj omenjenih podatkov in resnih zadržkov, ki jih je CVMP izrazil glede uporabe zdravila pri ciljnih vrstah kuncev, so se imetniki dovoljenj za promet z zdravilom strinjali z umikom vseh referenc na kunce iz informacij o zdravilu.
In a clinical trial, treatment of Pasteurellosis was performed with a dose of 25 mg/kg body weight.
V kliničnem preskušanju so izvedli zdravljenje bakterije Pasteurellosis z odmerkom 25 mg/kg telesne mase.
In a clinical field study including severe cases, treatment with tilmicosin at doses of either 5 mg/kg body weight or 10 mg/kg body weight resulted in a better cure rate as compared to the positive control group (amoxicillin 15 mg/kg body weight).
V klinični študiji na terenu, v katero so bili vključeni resni primeri, je zdravljenje s tilmikozinom pri odmerkih 5 mg/kg telesne mase ali 10 mg/kg telesne mase povzročilo višji odstotek ozdravitve v primerjavi s pozitivno kontrolno skupino (amoksicilin 15 mg/kg telesne mase).
In the event of either being observed, discard the vial.
Če opazite kar koli od navedenega, vialo zavrzite.
Sheep weighing 40 kg were more resistant and survived a subcutaneous dose of 150 mg/kg body weight, showing ataxia and lethargy.
Ovce s težo 40 kg so bile bolj odporne in so preživele subkutani odmerek 150 mg/kg telesne mase, vendar sta se pojavili ataksija in letargija.
The percentage of relapses was lowest in the 10 mg/kg body weight tilmicosin group, suggesting that this dose would be preferable.
Odstotek ponovitev bolezni je bil najnižji pri skupini, ki je prejemala tilmikozin v odmerku 10 mg/kg telesne mase, kar nakazuje, da je ta odmerek priporočljiv.
Do not administer intramuscularly.
Ne uporabljajte intramuskularno.
Pharmacokinetic data showed that tilmicosin was well distributed into the skin of sheep following subcutaneous injection at doses of 5 mg/kg body weight or 10 mg/kg body weight.
Farmakokinetični podatki so pokazali, da se je tilmikozin dobro porazdelil v koži ovac po subkutanem injiciranju pri odmerkih 5 mg/kg telesne mase ali 10 mg/kg telesne mase.
Injection of the product in goats and pigs has been fatal.
Injiciranje zdravila pri kozah in prašičih je povzročilo smrt.
In Staphylococcus aureus challenge study, tilmicosin treatment (10 mg/kg body weight as a single subcutaneous injection) in ewes resulted in significantly less mortality, and more normal udders at day 10 although milk samples were still bacteriologically positive in treated animals at day 10.
Pri študiji z umetno okužbo z bakterijo Staphylococcus aureus je zdravljenje s tilmikozinom (10 mg/kg telesne mase kot enkratno subkutano injiciranje) pri ovcah povzročilo znatno manjšo smrtnost in več normalnih vimen na 10. dan, čeprav so bili vzorci mleka na 10. dan pri zdravljenih živalih še vedno bakteriološko pozitivni.
Do not inject more than 2 ml per injection site.
V eno mesto injiciranja ne injicirajte več kot 2 ml.
• Never carry a syringe loaded with “product name (to be completed nationally)” with the needle attached.
• Injekcijske brizge, napolnjene z zdravilom »ime zdravila (izpolni država članica)«, nikoli ne prenašajte s pritrjeno iglo.
• the CVMP considered the scope of the referral was the harmonisation of the summary of product characteristics, labelling and package leaflet;
• CVMP je menil, da je bil namen napotitve uskladitev povzetka glavnih značilnosti zdravila,
Operator Safety Warnings
Varnostna opozorila za uporabnika
During an artificial respiratory infection study with M. haemolytica, a single subcutaneous injection at 10 mg/kg body weight resulted in a significant overall improvement compared to the control group.
Med študijo umetne okužbe dihal z bakterijo M. haemolytica je enkratno subkutano injiciranje pri odmerku 10 mg/kg telesne mase povzročilo pomembno splošno izboljšanje v primerjavi s kontrolno skupino.
Bacteria spp MIC (µg/ml) range MIC50 (µg/ml)
Bakterija spp Razpon MIC (µg/ml)
The Committee considered that the proposed indication “treatment of respiratory tract infections caused by M. haemolytica” had been sufficiently substantiated by data.
Odbor je menil, da je predlagana indikacija „zdravljenja okužb dihalnih poti, ki jih povzroča bakterija M. haemolytica“, zadostno utemeljena s podatki.
The posology is 10 mg tilmicosin per kg body weight which corresponds to 1 ml of product per 30 kg body weight.
Odmerjanje je 10 mg tilmikozina na kg telesne mase, kar ustreza 1 ml zdravila na 30 kg telesne mase.
FOR SUBCUTANEOUS INJECTION ONLY.
Samo za subkutano injiciranje.
For subcutaneous injection only.
SAMO ZA SUBKUTANO INJICIRANJE.
Read the fold out label or package leaflet before use.
Pred uporabo preberite navodila na preloženi nalepki in navodilo za uporabo.
Oedema at the site of injection was observed and at autopsy a light necrosis of the myocardium was the only lesion determined.
Opazili so edem na mestu injiciranja, pri obdukcij pa je bila edina ugotovljena lezija blaga nekroza miokardija.
When administered by injection, tilmicosin has a narrow safety of margin.
Pri dajanju z injiciranjem ima tilmikozin nižjo mejo varnosti.
Do not treat lamb weighing less than 15 kg, since there is a risk of overdosage toxicity.
Ne zdravite jagnjet s telesno maso, manjšo od 15 kg, saj obstaja tveganje toksičnosti zaradi prevelikega odmerjanja.
Furthermore, the text in the proposed indication “…and other microorganisms sensitive to tilmicosin” is not in accordance with recommendations in the CVMP reflection paper on macrolides, lincosamides and streptogramins (EMA/CVMP/SAGAM/741087/2009)1 and not in line with the CVMP guideline on the SPC for antimicrobials (EMEA/CVMP/SAGAM/383441/2005)2.
Nadalje besedilo v predlagani indikaciji „… in drugi mikroorganizmi, občutljivi na tilmikozin“ ni v skladu s priporočili iz presoje CVMP glede makrolidov, linkozamidov in streptograminov (EMA/CVMP/SAGAM/741087/2009)1 in z navodili CVMP v povzetku glavnih značilnosti zdravila za protimikrobna sredstva (EMEA/CVMP/SAGAM/383441/2005)2.
Regarding treatment of interdigital necrobacillosis in cattle, the in vitro studies demonstrated that the MIC values (MIC50 <0.25-0.5 µg/ml) of most major pathogens strains causing interdigital necrobacillosis in cattle, with the exception of treponeme infections, can be reached in the subcutaneous fat after a single subcutaneous injection with tilmicosin at a dose of 10 mg/kg body weight.
V zvezi z zdravljenjem interdigitalne nekrobaciloze pri govedu so in vitro študije pokazale, da je mogoče vrednosti MIK (MIK50 < 0,25−0,5 µg/ml) večine sevov pomembnejših patogenov, ki povzročajo interdigitalno nekrobacilozo pri govedu, razen okužb z bakterijo treponeme, doseči v subkutani maščobi po enkratnem subkutanem injiciranju tilmikozina pri odmerku 10 mg/kg telesne mase.
Doses of 150 mg/kg body weight, administered subcutaneously with an interval of 72 hours caused death.
Odmerki 150 mg/kg telesne mase, ki so se dajali subkutano z 72-urnimi presledki, so povzročili smrt.
Do not administer to lambs weighing less than 15 kg since there is a risk of overdose toxicity.
Ne uporabljajte pri jagnjetih s telesno maso, manjšo od 15 kg, saj obstaja tveganje za toksičnost zaradi prevelikega odmerjanja.
Accurate weighing of lambs is important to avoid overdosing.
Da se izognete prevelikemu odmerjanju, je pomembno natančno tehtanje jagnjet.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard carton
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla
Thus, based on the available data, the Committee considered the acceptable and more accurately described respiratory indication for cattle at the recommended dose of 10 mg/kg body weight should be: “Treatment of bovine respiratory disease associated with Mannheimia haemolytica and Pasteurella multocida”.
Na osnovi razpoložljivih podatkov je Odbor zato menil, da bi bila sprejemljiva in natančneje opisana indikacija za dihala pri govedu pri priporočenem odmerku 10 mg/kg telesne mase naslednja: „Zdravljenje bolezni dihal pri govedu, povezanih z bakterijama Mannheimia haemolytica in Pasteurella multocida“.
Deaths of cattle have been observed following a single intravenous dose of 5 mg/kg body weight, and following the subcutaneous injection of doses of 150 mg/kg body weight at 72 hour intervals.
Smrt govedi so opazili po enkratnem intravenskem odmerku 5 mg/kg telesne mase in po subkutanem injiciranju odmerkov 150 mg/kg telesne mase v 72-urnih presledkih.
Meat and offal: 42 days
Meso in drobovina: 42 dni
In dogs, treatment with intravenous calcium chloride showed a positive effect on the left ventricular inotropic state and some improvements in vascular blood pressure and tachycardia.
Pri psih je zdravljenje z intravenskim kalcijevim kloridom pokazalo pozitiven učinek na inotropno stanje levega prekata ter nekatere izboljšave žilnega krvnega tlaka in tahikardije.
Thus, based on the available data, the Committee considered the indication “treatment of interdigital necrobacillosis in cattle” is acceptable at the recommended dose of 10 mg/kg body weight.
Na podlagi razpoložljivih podatkov je zato Odbor menil, da je indikacija „zdravljenje interdigitalne nekrobaciloze pri govedu“ sprejemljiva pri priporočenem odmerku 10 mg/kg telesne mase.
OTHER INFORMATION “product name (to be completed nationally)” is contained in 25 ml, 50 ml, 100 ml or 250 ml amber glass vials (Type I or Type II) sealed with a rubber stopper and aluminium overseal.
Zdravilo »ime zdravila (izpolni država članica)« je v 25-, 50-, 100- ali 250-mililitrskih rumenorjavih steklenih vialah (tipa I ali II), zatesnjenih z gumijastim zamaškom in aluminijasto zaporko.
The cardiovascular system is the target of toxicity, and this toxicity may be due to calcium channel blockade.
Toksičnost je usmerjena na kardiovaskularni sistem, povzroča pa jo verjetno blokada kalcijevih kanalčkov.
Regarding the Haemophilus (Actinobacillus) and Mycoplasma the Committee considered that the data to substantiate these two pathogens were insufficient and the MAHs agreed to remove Haemophilus (Actinobacillus) and Mycoplasma from the respiratory indication for cattle.
V zvezi z bakterijama Haemophilus (Actinobacillus) in Mycoplasma je Odbor menil, da podatki za utemeljitev teh dveh patogenov niso bili zadostni in imetniki dovoljenj za promet z zdravilom so se strinjali z umikom bakterij Haemophilus (Actinobacillus) in Mycoplasma iz indikacije za dihala pri govedu.
Following oral or parenteral administration of tilmicosin the main target organ for toxicity is the heart.
Po peroralni ali parenteralni uporabi tilmikozina je toksičnost večinoma usmerjena na srce.
6.5 Nature and composition of immediate packaging 25 ml, 50 ml, 100 ml or 250 ml amber glass vials (Type I or Type II) sealed with a rubber stopper and aluminium overseal.
25-, 50-, 100- ali 250-mililitrske rumenorjave steklene viale (tipa I ali II), zatesnjene z gumijastim zamaškom in aluminijasto zaporko.
See fold out label or package leaflet for details.
Za podrobnosti glejte zloženko ali navodilo za uporabo.
NOTE TO PHYSICIAN: please see inside of label or package leaflet for details.
OPOMBA ZA ZDRAVNIKA: podrobnosti si oglejte v navodilu za uporabo.
Treatment of foot rot in sheep caused by Dichelobacter nodosus and Fusobacterium necrophorum.
Zdravljenje pododermatitisa, ki ga povzročata bakteriji Dichelobacter nodosus in Fusobacterium necrophorum.
Regarding the Haemophilus (Actinobacillus) and Mycoplasma the Committee considered that the data to substantiate these two pathogens were insufficient and the MAHs agreed to remove Haemophilus (Actinobacillus) and Mycoplasma from the respiratory indication for sheep.
V zvezi z bakterijama Haemophilus (Actinobacillus) in Mycoplasma je Odbor menil, da podatki za utemeljitev teh dveh patogenov niso zadostni in imetniki dovoljenj za promet z zdravilom so se strinjali z umikom bakterij Haemophilus (Actinobacillus) in Mycoplasma iz indikacije za dihala pri ovcah.
The use of a 2 ml or smaller syringe will facilitate accurate dosing.
Z uporabo 2mililitrske ali manjše injekcijske brizge bo odmerjanje natančnejše.
Studies demonstrated that tilmicosin at 10 mg tilmicosin/kg body weight has efficacy against acute mastitis in sheep caused by Staphylococcus aureus and Mycoplasma agalactiae although no bacterial cure was established.
Študije so pokazale, da je tilmikozin pri odmerku 10 mg/kg telesne mase učinkovit proti akutnemu mastitisu pri ovcah, ki ga povzročata bakteriji Staphylococcus aureus in Mycoplasma agalactiae, čeprav niso zabeležili nobene bakterijske ozdravitve.
Pigs given 4.5 to 5.6 mg tilmicosin/kg body weight intravenously with no epinephrine all survived.
Vsi prašiči, ki po intravenskem injiciranju od 4,5 do 5,6 mg tilmikozina/kg telesne mase niso prejeli adrenalina, so preživeli.
Meat and offal: 70 days
Meso in drobovina: 70 dni
In a field study, involving sheep with mastitis due to natural infection with Mycoplasma agalactiae, a single subcutaneous administration with tilmicosin at a dose of 10 mg/kg body weight resulted in significantly lower milkscores and overall udderscores compared to long-acting oxytetracycline.
V študiji na terenu, v katero so bile vključene ovce z mastitisom zaradi naravne okužbe z bakterijo Mycoplasma agalactiae, je enkratno subkutano injiciranje tilmikozina v odmerku 10 mg/kg telesne mase povzročilo znatno nižjo oceno mleka in celotno oceno vimena v primerjavi z dolgodelujočim oksitetraciklinom.
• Do not work alone when using “product name (to be completed nationally)”.
• Pri uporabi zdravila »ime zdravila (izpolni država članica)« ne smete biti povsem sami.
PACKAGE LEAFLET Product name (to be completed nationally)
Ime zdravila (izpolni država članica)
Phosphoric acid (for pH adjustment)
6.1 Seznam pomožnih snovi propilenglikol fosforna kislina (za uravnavanje pH) voda za injekcije
The available data demonstrated that tilmicosin is efficacious at the proposed dose of 10 mg tilmicosin/kg body weight against interdigital necrobacillosis in cattle and foot rot in sheep.
Razpoložljivi podatki so pokazali, da je tilmikozin učinkovit pri predlaganem odmerku 10 mg/kg telesne mase proti interdigitalni nekrobacilozi pri govedu in nalezljivi šepavosti ovac.
Micotil 300 Injectie is a solution for injection containing tilmicosin with a strength of 300 mg per ml.
Zdravilo Micotil 300 Injectie je raztopina za injiciranje, ki vsebuje tilmikozin, v jakosti 300 mg na ml. Tilmikozin je makrolidni antibiotik, sintetiziran iz tilozina.
Micotil 300 mg/ml
tilmikozin 300 mg/ml
Further to the serious concerns expressed by the CVMP about the proposed indication “as an aid in the in the control of outbreaks of enzootic abortion in ewes caused by Chlamydia psittaci” the MAHs agreed to remove all reference to this indication from the product information.
Glede na resne zadržke, ki jih je CVMP izrazil glede predlagane indikacije „kot pomoč pri obvladovanju izbruhov enzootskega zvrgavanja ovac, ki ga povzroča bakterija Chlamydia psittaci”, so se imetniki dovoljenj za promet z zdravilom strinjali z umikom vseh referenc na to indikacijo iz informacij o zdravilu.
The clinical trials did not demonstrate a bacteriological cure in sheep with acute mastitis caused by Staphyloccocus aureus and Mycoplasma agalactiae.
Klinična preskušanja niso pokazala bakteriološke ozdravitve pri ovcah z akutnim mastitisom, ki ga povzročata bakteriji Staphyloccocus aureus in Mycoplasma agalactiae.
Further to the serious concerns expressed by the CVMP regarding the use of the product in the target species rabbits and as “aid in the control of outbreaks of enzootic abortion in ewes caused by Chlamydia psittaci” the MAHs agreed to remove all references to rabbits and enzootic abortion in ewes from the product information.
Glede na resne zadržke, ki jih je CVMP izrazil glede uporabe zdravila pri ciljnih vrstah kuncev in kot „pomoč pri obvladovanju izbruhov enzootskega zvrgavanja ovac, ki ga povzroča bakterija Chlamydia psittaci”, so se imetniki dovoljenj za promet z zdravilom strinjali z umikom vseh referenc na kunce in enzootsko zvrgavanje ovac iz informacij o zdravilu.
Thus, based on the available data the Committee considered the indication “treatment of foot rot in sheep associated with Dichelobacter nodosus and Fusobacterium necrophorum” was acceptable at the recommended dose of 10 mg/kg body weight.
Na osnovi razpoložljivih podatkov je Odbor zato menil, da je indikacija „zdravljenja nalezljive šepavosti ovac, povezane z bakterijama Dichelobacter nodosus in Fusobacterium necrophorum“ sprejemljiva pri priporočenem odmerku 10 mg/kg telesne mase.
Restrain the animal and insert separate needle subcutaneously at the injection site, preferably in a skinfold over the rib cage behind the shoulder.
Žival imobilizirajte in novo iglo subkutano vstavite v mesto injiciranja, najbolje v kožno gubo nad rebri za plečetom.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: Varnostna opozorila za uporabnika
Therefore the following warning sentences should be added in SPC section 4.11 Withdrawal period(s): (i) “If the product is administered to cows during the dry period (in accordance with section 4.7 of the SPC), milk should not be used for human consumption until 36 days after calving” and (ii) “If the product is administered to ewes during the dry period (in accordance with section 4.7 of the SPC), milk should not be used for human consumption until 18 days after lambing”.
V poglavje 4.11 Karenca v povzetku glavnih značilnosti zdravila je zato treba dodati naslednje opozorilne stavke: (i) „če se zdravilo daje kravam v presušitvi (v skladu s poglavjem 4.7 povzetka glavnih značilnosti zdravila), mleka ni dovoljeno uporabiti za prehrano ljudi do 36 dni po otelitvi“ in (ii) „če se zdravilo daje ovcam v presušitvi (v skladu s poglavjem 4.7 povzetka glavnih značilnosti zdravila), mleka ni dovoljeno uporabiti za prehrano ljudi do 18 dni po jagnjitvi“.
4.8 Interaction with other medicinal products and other forms of interaction
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Pri nekaterih vrstah so opazili interakcije med makrolidi in ionofori.
NAME OF THE VETERINARY MEDICINAL PRODUCT To be completed nationally
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Attach the syringe to the needle and inject into the base of the skinfold.
Na iglo pritrdite injekcijsko brizgo in injicirajte v središče kožne gube.
PHARMACEUTICAL FORM Solution for injection.
FARMACEVTSKA OBLIKA Raztopina za injiciranje Bistra raztopina
Do not administer intravenously.
Ne uporabljajte intravensko.
Treatment of bovine respiratory disease associated with Mannheimia haemolytica and Pasteurella multocida.
Zdravljenje respiratorne bolezni goveda, povezane z bakterijama Mannheimia haemolytica in Pasteurella multocida.
Sheep have died following a single intravenous injection of 7.5 mg/kg body weight.
Pri ovcah je nastopila smrt po enkratnem intravenskem injiciranju 7,5 mg/kg telesne mase.
Regarding the cattle and sheep withdrawal periods there may be a concern that if the product is administered to an animal during the dry period, residues may continue to be present in milk for days after parturition.
V zvezi s karencami pri govedu in ovcah morda obstaja zadržek, da so lahko pri dajanju zdravila živali v presušitvi ostanki v mleku prisotni še več dni po porodu.
Treatment of acute ovine mastitis caused by Staphylococcus aureus and Mycoplasma agalactiae.
Zdravljenje akutnega mastitisa pri ovcah, ki ga povzročata bakteriji Staphylococcus aureus in Mycoplasma agalactiae.