FrancophonIA/ELRC3.0 huggingface dataset:
English: Microscopic characteristics of the lesions suggest an ongoing repair process.
Croatian: Mikroskopske karakteristike lezija ukazuju na to da je oporavak u tijeku.
English: Each chewable tablet contains:
Croatian: Svaka tableta za žvakanje sadrži:
English: Torasemide has a chemical structure between those of loop diuretics (such as furosemide) and Cl channel blockers.
Croatian: Torasemid ima kemijsku strukturu između diuretika Henleove petlje (poput furosemida) i blokatora kalcijskih kanala.
English: In case of overdose, treatment would be at the discretion of the responsible veterinarian, based on the presenting signs.
Croatian: U slučaju predoziranja, o liječenju treba odlučiti odgovorni veterinar na temelju prisutnih znakova.
English: The following table shows the dose adjustment scheme within the recommended dose range of 0.13 to 0.4 mg/kg/day:
Croatian: Sljedeća tablica prikazuje shemu prilagodbe doze unutar preporučenog raspona doze od 0,13 do 0,4 mg/kg/dnevno:
English: Each chewable tablet contains: 1 mg of torasemide
Croatian: Svaka tableta za žvakanje sadrži: 1 mg torasemida
English: If symptoms of allergy occur, seek medical advice and show the product packaging to the physician.
Croatian: Ako se pojave simptomi alergije, zatražite pomoć liječnika i pokažite mu pakovanje proizvoda.
English: Torasemide has a more potent, longer-acting diuretic activity than furosemide.
Croatian: Torasemid ima snažnije i dugotrajnije diuretsko djelovanje od furosemida.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Croatian: Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijal dobiven primjenom tog veterinarsko-medicinskog proizvoda mora se odlagati u skladu s lokalnim propisima.
English: The proportion of torasemide excreted in the urine is approximately the same in fasted or fed conditions (61% vs. 59% respectively).
Croatian: Udio torasemida izlučenog u urinu približno je isti kod primjene natašte i nakon jela (61 % u odnosu na 59 %).
English: Doses of 0.26 mg/kg and higher should only be administered for a maximum period of 5 days.
Croatian: Doze od 0,26 mg/kg i veće ne smiju se primjenjivati dulje od 5 dana.
English: The tablets are flavoured.
Croatian: Tablete su aromatizirane.
English: For treatment of clinical signs related to congestive heart failure in dogs, including pulmonary oedema.
Croatian: Za liječenje kliničkih znakova povezanih s kongestivnim zatajenjem srca, uključujući i plućni edem.
English: The parent substance is metabolised by the hepatic cytochrome P450 families 3A4 and 2E1, and to a lesser extent by 2C9.
Croatian: Izvorna tvar metabolizirana je jetrenim citokromom P450 obitelji 3A4 i 2E1 i u manjoj mjeri 2C9.
English: Torasemide can reduce the renal excretion of salicylates, leading to an increased risk of toxicity.
Croatian: Torasemid može smanjiti renalno izlučivanje salicilata, što može dovesti do povećanog rizika od toksičnosti.
English: In case of moderate or severe pulmonary oedema, this dose can be increased if necessary up to a maximum dose of 0.4 mg/kg bodyweight/day once daily.
Croatian: U slučaju umjerenog do teškog plućnog edema, ova se doza može povećati, ako je potrebno, do maksimalne doze od 0,4 mg/kg tjelesne težine/jednom dnevno.
English: The dose should be adjusted to maintain patient comfort with attention to renal function and electrolytes status.
Croatian: Dozu treba prilagoditi kako bi se pacijent dobro osjećao uz praćenje statusa bubrežne funkcije i elektrolita.
English: Any part-used tablets should be returned to the blister pack and then to the original carton to help prevent access by children.
Croatian: Sve djelomično iskorištene tablete treba vratiti u pakovanje s blisterima i originalnu kutiju kako bi se spriječio pristup djece tabletama.
English: Special warnings for each target species:
Croatian: Posebna upozorenja za svaku ciljnu vrstu životinja:
English: Pack sizes of 30 or 90 tablets.
Croatian: Veličine pakovanja od 30 ili 90 tableta.
English: People with known hypersensitivity to torasemide, to sulfonamides or to any of the excipients should avoid contact with the veterinary medicinal product.
Croatian: Osobe preosjetljive na torasemid, sulfonamide ili na bilo koji drugi sastojak trebaju izbjegavati kontakt s ovim veterinarsko-medicinskim proizvodom.
English: In dogs, following a single intravenous dose of 0.2 mg torasemide/kg bodyweight, the mean total clearance was 22.1 mL/h/kg, with a mean volume of distribution of 166 mL/kg and a mean terminal half-life of about 6 hours.
Croatian: U pasa, nakon jedne intravenozne doze od 0,2 mg torasemida/kg tjelesne težine, srednji ukupni klirens bio je 22,1 mL/h/kg, sa srednjim volumenom distribucije od 166 mL/kg i srednjim terminalnim poluživotom od oko 6 sati.
English: Keep the tablets out of the reach of animals in order to avoid any accidental ingestion.
Croatian: Čuvajte tablete izvan dohvata životinja kako biste spriječili neželjeno gutanje.
English: No accumulation of torasemide is observed after repeated once daily oral administration for 10 days, whatever the dose administered (ranging from 0.1 to 0.4 mg/kg) even if a slight supra dose proportionality is observed.
Croatian: Nije primijećena akumulacija torasemida nakon ponavljanja oralne primjene jednom dnevno tijekom 10 dana, bez obzira na primijenjenu dozu (od 0,1 do 0,4 mg/kg) čak i ako je primijećena određena proporcionalnost iznad doze.
English: In a clinical field trial, the efficacy of Isemid was demonstrated when it was used as a first line treatment.
Croatian: U kliničkim terenskim ispitivanjima učinak Isemida je dokazan kada se primjenjivao kao primarna terapija.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (30 tablets)
Croatian: PODACI NA VANJSKOM PAKOVANJU Kartonska kutija (30 tableta)
English: Once signs of congestive heart failure have been controlled and the patient is stable, it should be continued at the lowest effective dose, if long term diuretic therapy with this product is required.
Croatian: Kada se znakovi kongestivnog zatajenja srca stave pod kontrolu i pacijent postane stabilan, treba nastaviti s primjenom minimalne učinkovite doze, ako se zahtijeva dugotrajna diuretska terapija ovim proizvodom.
English: The diuretic response to torasemide may increase over time upon repeated dosing, particularly at doses greater than 0.2 mg/kg/day; therefore more frequent monitoring should be considered.
Croatian: Diuretski učinak torasemida može se povećati s vremenom nakon ponovljene primjene doza, posebice pri dozama većim od 0,2 mg/kg/dnevno; stoga će možda biti potrebno češće nadziranje.
English: ECG alterations without any clinical signs (increase in P wave and/or QT interval) were observed in some animals after the administration of 5 times the highest recommended dose.
Croatian: Promjene EKG-a bez drugih kliničkih znakova (povećanje vala P i/ili intervala QT) primijećene su kod nekih životinja nakon primjene doze 5 puta veće od najveće preporučene doze.
English: Pharmacotherapeutic group: Cardiovascular system, high-ceiling diuretics, plain sulfonamides ATC vet code: QC03CA04
Croatian: Farmakoterapijska grupa: Kardiovaskularni sustav, diuretici snažnog učinka, obični sulfonamidi ATC klasifikacija veterinarsko-medicinskih proizvoda QC03CA04
English: In cases of co-administration with amphotericin B, increased potential for nephrotoxicity and intensification of electrolyte imbalance can be observed.
Croatian: U slučajevima istovremene primjene s amfotericinom B, može se primijetiti povećana mogućnost nefrotoksičnosti i intenziviranja neravnoteže elektrolita.
English: Therefore, diuretic activity of torasemide correlates better with the rate of torasemide excretion in the urine than with the concentration in the blood.
Croatian: Stoga diuretska aktivnost torasemida korelira bolje s brzinom izlučivanja torasemida u urinu nego s koncentracijom u krvi.
English: Consequently, water reabsorption from the collecting duct is inhibited and the volume of water on the luminal side is increased.
Croatian: Kao posljedica toga, reapsorpcija vode iz kanala za prikupljanje inhibirana je i volumen vode na luminalnoj strani se povećava.
English: The effect of antihypertensive veterinary medicinal products, especially angiotensin converting enzyme (ACE)-inhibitors, may be potentiated when co-administered with torasemide.
Croatian: Učinak antihipertenzivnih veterinarsko-medicinskih proizvoda, posebice inhibitora enzima konverzije angiotenzina (ACE), može biti pojačan kod istovremene primjene s torasemidom.
English: After oral administration of 0.2 mg torasemide/kg bodyweight, the absolute bioavailability is about 99% based on plasma concentration-time data and 93% based on urine concentration-time data.
Croatian: Nakon oralne primjene 0,2 mg torasemida/kg tjelesne težine, apsolutna bioraspoloživost je oko 99 % na temelju podataka o koncentraciji plazme tijekom vremena i 93% na temelju podataka o koncentraciji urina tijekom vremena.
English: Concomitant use with NSAIDs, aminoglycosides or cephalosporins may increase the risk of nephrotoxicity and/or ototoxicity of those medicinal products.
Croatian: Istovremena primjena s NSPUL-ima, aminoglikozidima ili cefalosporinima može povećati rizik od nefrotoksičnosti i/ili ototoksičnosti tih lijekova.
English: Remaining tablet parts should be stored in the blister and be given at the next administration.
Croatian: Preostale dijelove tableta treba pohraniti u blister i dati prilikom sljedeće primjene.
English: Torasemide should be used with caution in cases of diabetes mellitus.
Croatian: Torasemid treba oprezno primjenjivati u slučaju dijabetesa melitusa.
English: > 40 to 60
Croatian: > 40 do 60
English: EU/2/18/232/001 - 006
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/18/232/001 - 006
English: No pharmacokinetic interactions have been reported following co-administration of torasemide with digoxin; however hypokalaemia can enhance digoxin-induced arrhythmias.
Croatian: Farmakokinetičke interakcije nisu prijavljene nakon istovremene primjene torasemida i digoksina; no hipokalijemija može pojačati aritmiju induciranu digoksinom.
English: Concomitant administration of torasemide with other substances metabolised by cytochrome P450 families 3A4 (e.g.: enalapril, buprenorphine, doxycycline, cyclosporine) and 2E1 (isoflurane, sevoflurane, theophylline) may decrease their clearance from the systemic circulation.
Croatian: Istovremena primjena torasemida i drugih tvari koje se metaboliziraju putem citokroma P450 obitelji 3A4 (npr. enalaprila, buprenorfina, dioksiciklina, ciklosporina) i 2E1 (izoflurana, sevoflurana, teofilina) može smanjiti izlučivanje iz sustavne cirkulacije.
English: In cases of co-administration with corticosteroids, the effects of loss of potassium may be potentiated.
Croatian: U slučajevima istovremene primjene s kortikosteroidima, učinak gubitka kalija može se potencirati.
English: Ceva Santé Animale 10 av. de La Ballastière 33500 Libourne France
Croatian: Ceva Santé Animale 10 av. de La Ballastière 33500 Libourne Francuska
English: In case of accidental ingestion, particularly by a child, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju slučajnog gutanja, posebice ako su u pitanju djeca, odmah zatražite pomoć liječnika i pokažite mu uputu o lijeku ili etiketu.
English: The following clinical signs were observed commonly: episodic gastrointestinal signs such as vomiting and diarrhoea, dehydration, polyuria, polydipsia, urinary incontinence, anorexia, weight loss and lethargy.
Croatian: Često su primijećeni sljedeći klinički znakovi: povremeni gastrointestinalni znakovi kao što su povraćanje i proljev, dehidracija, poliurija, polidipsija, urinarna inkontinencija, anoreksija, gubitak težine i letargija.
English: > 8 to 11.5
Croatian: > 8 do 11,5
English: Transient dose response alterations in the adrenal glands, consisting of minimal to moderate reactive hypertrophy/hyperplasia, presumably related to high production of aldosterone, were observed in the dogs treated with up to 5 times the highest therapeutic recommended dose.
Croatian: Promjene nadbubrežne žlijezde uslijed reakcije na prolaznu dozu, koje se sastoje od minimalne do umjerene reaktivne hipertrofije/hiperplazije, vjerojatno povezane s povećanom proizvodnjom aldosterona, primijećene su u pasa kod kojih su primjenjivane doze do 5 puta veće od najveće preporučene terapijske doze.
English: The initial/maintenance dose may be temporarily increased when pulmonary oedema becomes more severe, i.e. reaching alveolar oedema state (see section 4.9).
Croatian: Početna doza/doza održavanja može se privremeno povećati ako plućni edem postane ozbiljniji, tj. dođe do stanja alveolarnog edema (vidi odjeljak 4.9).
English: In case of loss of appetite and/or vomiting and/or lethargy or in case of treatment adjustment, renal function (blood urea and creatinine as well as urine protein:creatinine (UPC) ratio) should be assessed.
Croatian: U slučaju gubitka apetita i/ili povraćanja i/ili letargije ili u slučaju prilagodbe liječenja, potrebno je procijeniti bubrežnu funkciju (ureju i kreatinin u krvi, kao i protein u urinu: omjer proteina i kreatinina u urinu).
English: Transferring treatment from an alternative loop diuretic to this veterinary medicinal product has not been evaluated and such a change should only be implemented based on a benefit-risk assessment performed by the responsible veterinarian.
Croatian: Prijelaz liječenja s drugog diuretika Henleove petlje na ovaj veterinarsko-medicinski proizvod nije procijenjen te takvu promjenu treba provesti samo na temelju procjene koristi i rizika od strane odgovornog veterinara.
English: > 15 to 23
Croatian: > 15 do 23
English: Marketing authorisation holder: Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne France
Croatian: Nositelj odobrenja za stavljanje u promet Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne
English: After administration of 3 and 5 times the highest therapeutic recommended dose to healthy dogs, a decrease of appetite was observed which led to a weight loss in some cases.
Croatian: Nakon primjene trostruko i peterostruko veće doze od najveće preporučene terapijske doze u zdravih pada primijećeno je smanjenje apetita koje je u nekim slučajevima dovelo do gubitka težine.
English: In dogs with pre-existing electrolyte and/or water imbalance, this should be corrected prior to treatment with torasemide.
Croatian: Kod pasa kod kojih od prije postoji neravnoteža elektrolita i/ili vode potrebno je prije primjene torasemida korigirati to stanje.
English: Torasemide causes a significant, dose-dependent increase in urine flow and the urinary excretion of sodium and potassium.
Croatian: Torasemid prouzročuje znatno povećanje protoka urina ovisno o dozi i izlučivanje natrija i kalija urinom.
English: Torasemide belongs to the pyridine-3-sulfonylurea class of loop diuretics, also called high-ceiling diuretics.
Croatian: Torasemid pripada klasi piridine-3-sulfonilureje diuretika Henleove petlje, također zvanima i diureticima snažnog učinka.
English: Lactose monohydrate Cellulose microcrystalline Povidone (K30) Pork liver powder flavour Compressible sugar Crospovidone (type B) Magnesium stearate
Croatian: Monohidrat laktoze Celuloza, mikrokristalična Povidon (K30) Prah s okusom svinjske jetre Stlačiv šećer
English: Care should be exercised when administering torasemide with other highly plasma protein bound drugs.
Croatian: Potrebno je biti pažljiv pri primjeni torasemida s drugim lijekovima koji se lako vežu za proteine plazme.
English: The recommended initial/maintenance dose is 0.13 to 0.25 mg torasemide/kg bodyweight/day, once daily.
Croatian: Preporučena početna doza/doza održavanja je 0,13 do 0,25 mg torasemida/kg tjelesne težine/jednom dnevno.
English: (0.26 to 0.40 mg/kg/day)
Croatian: Privremena visoka doza (0,26 do 0,40 mg/kg/dnevno)
English: The initial/maintenance dose may be temporarily increased when pulmonary oedema becomes more severe, i.e. reaching alveolar oedema state (see section "Dosage for each species, route(s) and method of administration").
Croatian: Početna doza/doza održavanja može se privremeno povećati ako plućni edem postane ozbiljniji, tj. dođe do stanja alveolarnog edema (vidi odjeljak “Doziranje za svaku ciljnu vrstu životinja, načini i put(evi) primjene“).
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Croatian: Tiskana uputa o VMP mora sadržavati naziv i adresu proizvođača odgovornog za puštanje serije u promet.
English: Do not use concomitantly with other loop diuretics.
Croatian: Ne primjenjivati istovremeno s drugim diureticima Henleove petlje.
English: 4 mg of torasemide The tablets are brown coloured, oblong shaped, chewable and can be divided into halves.
Croatian: Tablete su smeđe boje, duguljastog oblika, namijenjene su za žvakanje i mogu se podijeliti na dvije polovice.
English: Feeding significantly increased torasemide AUC0-∞ by 37% and slightly delayed Tmax, but in fasted and fed conditions the maximal concentrations (Cmax) are approximately the same (2015 µg/L vs 2221 µg/L, respectively).
Croatian: Hranjenje je znatno povećalo AUC0-∞ torasemida za 37% i malo odgodilo Tmax, no natašte i nakon jela maksimalne koncentracije (Cmax) približno su iste (2015 µg/L odnosno 2221 µg/L).
English: > 11.5 to 15
Croatian: > 11,5 do 15
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton or blister pack after "EXP".
Croatian: Ne koristiti poslije isteka roka valjanosti naznačenog na kutiji i ili blisteru iza "EXP".
English: In dogs with acute pulmonary oedema requiring emergency treatment, the use of injectable medicinal products should be considered first before commencing oral diuretic therapy.
Croatian: Kod pasa s akutnim plućnim edemom koji zahtijeva hitno liječenje, prije primjene oralne terapije potrebno je razmotriti mogu li se primijeniti medicinski proizvodi koji se daju injekcijom.
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Croatian: UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE C. IZVJEŠĆE O MRL
English: Since protein binding facilitates the renal secretion of torasemide, a decrease in binding due to displacement by another drug may be a cause of diuretic resistance.
Croatian: Budući da vezanje za proteine olakšava renalno izlučivanje torasemida, smanjenje vezivanja zbog istiskivanja drugim lijekom može prouzročiti otpornost na diuretike.
English: torasemide
Croatian: NUSPOJAVE
English: Renal function (measurement of blood urea and creatinine as well as urine protein: creatinine (UPC) ratio), hydration status and serum electrolytes status should be monitored prior to and during treatment at very regular intervals according to the benefit-risk assessment performed by the responsible veterinarian (see sections 4.3 and 4.6 of the SPC).
Croatian: Bubrežna funkcija (mjerenje ureje i kreatinina u krvi, kao i proteina u urinu: omjer proteina i kreatinina u urinu), status hidratacije i status elektrolita u serumu treba pratiti prije i tijekom liječenja u redovitim intervalima u skladu s procjenom koristi i rizika koju izvrši odgovorni veterinar (vidi odjeljke 4.3 i 4.6 SPC).
English: Special precautions for use in animals:
Croatian: Posebne mjere predostrožnosti za primjenu na životinjama:
English: > 23 to 30
Croatian: > 23 do 30
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e) ) - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja ) - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
English: Monitoring of glycaemia in diabetic animals is recommended prior to and during treatment.
Croatian: Prije i tijekom liječenja preporučuje se praćenje glikemije kod životinja s dijabetesom.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY
Croatian: 13. POSEBNE MJERE PREDOSTROŽNOSTI ZA ODLAGANJE NEUPOTREBLJENOG PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
English: > 30 to 40
Croatian: > 30 do 40
English: Torasemide may antagonise the action of oral hypoglycaemic agents.
Croatian: Torasemid može djelovati antagonistički djelovanju oralnih antidijabetika.
English: Furthermore, the diuretic effect of torasemide is approximately the same in fed and fasted conditions.
Croatian: Osim toga, diuretički učinak torasemida približno je isti ako se primjenjuje natašte i nakon jela.
English: The primary site of action of torasemide is the thick ascending limb of the loop of Henle, where it interacts with the Na +-K
Croatian: Primarno mjesto djelovanja torasemida je debeli uzlazni krak Henleove petlje, gdje međudjeluje s kotransporterom
English: - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Croatian: - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja ) - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
English: After administration to healthy dogs of 3 times and 5 times the maximum dose for 5 consecutive days followed by 177 daily administrations of 3 times and 5 times the highest therapeutic recommended dose for maintenance, histopathological changes in the kidneys (interstitial inflammation, dilatation of renal tubules and subscapular cysts) were noted in addition to the effects observed after the administration of the recommended dose (see section 4.6).
Croatian: Nakon primjene trostruko i peterostruko većih doza lijeka od maksimalne tijekom 5 uzastopnih dana na zdravim psima nakon čega je slijedila primjena tijekom 177 dana trostruko i peterostruko većih doza od maksimalne preporučene terapijske doze održavanja, primijećene su histopatološke promjene na bubrezima (intersticijska upala, dilatacija renalnih tubula i subskapularne ciste) osim učinaka primijećenih nakon primjene preporučene doze (vidi odjeljak 4.6).
English: Other effects consistent with the pharmacological activity of torasemide were observed in pre-clinical studies in healthy dogs at the recommended dose, i.e. dry mucosa of the oral cavity, reversible increases in glucose and aldosterone serum concentrations, decrease in urine specific gravity and increase in urine pH were observed in pre-clinical studies in healthy dogs at the recommended dose.
Croatian: Drugi učinci u skladu s djelovanjem torasemida primijećeni su u pretkliničkim ispitivanjima u zdravih pasa pri preporučenim dozama, tj. primijećeni su suha sluznica usne šupljine, reverzibilno povećanje koncentracija glukoze i aldosterona u serumu, smanjenje specifične težine urina i povećanje pH vrijednosti urina u pretkliničkim ispitivanjima u zdravih pasa pri preporučenim dozama.