FrancophonIA/ELRC3.0 huggingface dataset:
English: No pharmacokinetic interactions have been reported following co-administration of torasemide with digoxin; however hypokalaemia can enhance digoxin-induced arrhythmias.
Danish: Der er ikke blevet rapporteret om farmakokinetiske interaktioner ved samtidig brug af digoxin og torasemid; dog kan hypokaliæmi forstærke digoxin-inducerede arytmier.
English: The causative role of changes in plasma electrolyte values cannot be excluded.
Danish: Den kausative rolle af elektrolytforstyrrelser kan ikke udelukkes.
English: Torasemide belongs to the pyridine-3-sulfonylurea class of loop diuretics, also called high-ceiling diuretics.
Danish: Torasemid er et loop-diuretikum, der tilhører pyridin-3-sulfonylureaklassen, også kaldet ”high ceiling” diuretika.
English: Special precautions for use in animals:
Danish: Særlige forsigtighedsregler til brug hos dyr:
English: Lactose monohydrate Cellulose microcrystalline Povidone (K30) Pork liver powder flavour Compressible sugar Crospovidone (type B) Magnesium stearate
Danish: Lactosemonohydrat Cellulose, mikrokrystallinsk Povidon (K30) Griseleversmag, pulver Komprimerbart saccharose Crospovidon (type B) Magnesiumstearat
English: Each chewable tablet contains: 1 mg of torasemide
Danish: Hver tyggetablet indeholder: 1 mg torasemid
English: Ceva Santé Animale 10 av. de La Ballastière 33500 Libourne France
Danish: Ceva Santé Animale 10 av. de La Ballastière 33500 Libourne Frankrig
English: Any part-used tablets should be returned to the blister pack and then to the original carton to help prevent access by children.
Danish: Tabletdele skal returneres til blisterpakningen og derefter lægges i den originale yderpakning for at forhindre tilgængelighed for børn.
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE ANSVARLIG FOR BATCHFRIGIVELSE
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.
Danish: I tilfælde af moderat eller svært pulmonært ødem kan denne dosis øges, om nødvendigt op til en max dosis på 0,4 mg/kg legemsvægt/dag én gang dagligt.
English: Torasemide can reduce the renal excretion of salicylates, leading to an increased risk of toxicity.
Danish: Torasemid kan reducere den renale udskillelse af salicylater, hvilket kan føre til en øget risiko for toksicitet.
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).
Danish: Fodring øgede signifikant torasemid AUC0-∞ med 37% og forsinkede Tmax en smule, mens den maksimale koncentration (Cmax) er omtrent den samme under fastende og fodrede forhold (2015 µg/l kontra 2221 µg/l, respektivt).
English: > 40 to 60
Danish: > 40 til 60
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.
Danish: I tilfælde af selvindgivelse ved hændeligt uheld, i særdeleshed hos børn, skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: Co-administration of loop diuretics and NSAIDs can result in a decreased natriuretic response.
Danish: Samtidig administration af loop-diuretika og NSAID'er kan resultere i et mindsket natriuretisk respons.
English: Marketing authorisation holder: Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne France
Danish: Indehaver af markedsføringstilladelsen: Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne
English: +-2Cl cotransporter localised in the luminal membrane (urine side) and blocks the active reabsorption of sodium and chloride.
Danish: --cotransportøren lokaliseret i den luminale membran (urinsiden) blokerer den aktive reabsorption af natrium og klorid.
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.
Danish: Forbigående, dosisafhængige forandringer i binyrerne, bestående a minimalt til moderat reaktiv hypertrofi/hyperplasi, sandsynligvis relateret til høj aldosteronproduktion, blev observeret hos hunde behandlet med op til 5 gange den højeste anbefalede terapeutiske dosis.
English: If the tablet is not spontaneously taken by the dog, it can also be given with food or directly into the mouth.
Danish: Tabletten kan gives sammen med mad eller direkte i munden, hvis den ikke indtages spontant af hunden.
English: > 8 to 11.5
Danish: > 8 til 11,5
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.
Danish: EKG-forandringer uden kliniske tegn (stigning i P-tak og/eller QT interval) blev observeret hos nogle dyr efter administration af 5 gange den højeste anbefalede dosis.
English: Torasemide causes a significant, dose-dependent increase in urine flow and the urinary excretion of sodium and potassium.
Danish: Torasemid udløser en signifikant, dosisafhængig stigning i urinproduktionen og udskillelse af natrium og kalium i urinen.
English: Since the ascending limb of the loop of Henle is impermeable to water, the inhibition of Na and Cl movement from the lumen to the interstitial space increases the concentration of ions in the lumen and produces a hypertonic medullary interstitium.
Danish: Eftersom det ascenderende ben af Henles slynge er uigennemtrængeligt for vand, foranlediger den hæmmede bevægelse af Na og Cl fra lumen til interstitiet en stigning i koncentration af ioner i lumen, hvilket resulterer i et hypertonisk medullært interstitium.
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.
Danish: De følgende kliniske tegn var almindelige: episodiske gastrointestinale tegn såsom opkast og diarré, dehydrering, polyuri, polydipsi, inkontinens, anorexi, vægttab og sløvhed.
English: Manufacturer responsible for batch release: Ceva Santé Animale
Danish: Fremstiller ansvarlig for batchfrigivelse: Ceva Santé Animale ZI Très le Bois
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.
Danish: Samtidig administration af torasemid med andre substanser, der metaboliseres af cytochrom P450 familierne 3A4 (fx enalapril, buprenorfin, doxycyclin, cyclosporin) og 2E1 (isofluran, sevofluran, theofyllin) kan nedsætte deres udskillelse fra den systemiske cirkulation.
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.
Danish: Efter gentagne orale doseringer (én gang dagligt) i 10 dage blev akkumulering af torasemid ikke observeret, uanset dosis (fra 0,1 til 0,4 mg/kg) selv hvis en let supra dose proportionality (tendens til akkumulering ved høje doser) kan ses.
English: Do not use in cases of renal failure.
Danish: Bør ikke anvendes i tilfælde af nyresvigt
English: In dogs with pre-existing electrolyte and/or water imbalance, this should be corrected prior to treatment with torasemide.
Danish: Hos hunde med allerede eksisterende elektrolyt- og/eller væske-forstyrrelser, bør dette reguleres før behandling med torasemid påbegyndes.
English: > 15 to 23
Danish: > 15 til 23
English: torasemide
Danish: torasemid
English: In case of overdose, treatment would be at the discretion of the responsible veterinarian, based on the presenting signs.
Danish: I tilfælde af overdosis, behandles symptomatisk efter anvisning af den ansvarlige dyrlæge.
English: In cases of co-administration with corticosteroids, the effects of loss of potassium may be potentiated.
Danish: Ved samtidig behandling med kortikosteroider kan effekterne af kaliumtab forstærkes.
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.
Danish: Andre effekter forenelige med den farmakologiske aktivitet af torasemid blev observeret i prækliniske studier hos raske hunde ved den anbefalede dosis, dvs. tørre slimhinder i mundhulen, reversible stigninger i serumkoncentrationen af glukose og aldosteron, nedsat urin-specifik vægtfylde og stigning i pH af dyrets urin.
English: The effect of antihypertensive veterinary medicinal products, especially angiotensin converting enzyme (ACE)-inhibitors, may be potentiated when co-administered with torasemide.
Danish: Effekten af blodtrykssænkende veterinære lægemidler, i særdeleshed angiotensinkonverterende enzym (ACE)-hæmmere, kan forstærkes ved samtidig administration af torasemid.
English: Torasemide may antagonise the action of oral hypoglycaemic agents.
Danish: Torasemid kan modvirke effekten af orale hypoglykæmiske lægemidler.
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.
Danish: Eftersom proteinbinding faciliterer nyrens udskillelse af torasemid, kan en nedsat plasmaproteinbinding forårsaget af konkurrence fra andre lægemidler være en årsag til diuretisk resistens.
English: In cases of co-administration with amphotericin B, increased potential for nephrotoxicity and intensification of electrolyte imbalance can be observed.
Danish: Ved samtidig behandling med amphotericin B, kan observeres øget potentiale for nyreskade samt intensivering af elektrolytforstyrrelser.
English: 4 mg of torasemide The tablets are brown coloured, oblong shaped, chewable and can be divided into halves.
Danish: Tyggetabletterne er brune, aflange og kan deles i to halvdele.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: In a clinical field trial, the efficacy of Isemid was demonstrated when it was used as a first line treatment.
Danish: Effekten af Isemid som førstevalgsbehandling er blevet demonstreret i et klinisk feltstudie.
English: If symptoms of allergy occur, seek medical advice and show the product packaging to the physician.
Danish: Søg lægehjælp, hvis der opstår symptomer på allergi, og vis pakningen til lægen.
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.
Danish: I tilfælde af nedsat appetit og/eller opkast og/eller sløvhed eller i tilfælde af dosisjustering, bør nyrefunktionen (koncentration af urinstof og kreatinin i blodet, såvel som urinprotein-kreatinin (UPC) forholdet) kontrolleres.
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").
Danish: Den initiale dosis eller vedligeholdelsesdosen kan midlertidigt øges ved mere udtalt lungeødem, dvs. ved udvikling af alveolært ødem (se afsnit ”Dosering for hvert dyreart, anvendelsesmåde og indgivelsesvej(e)”).
English: > 23 to 30
Danish: > 23 til 30
English: The safety and efficacy of the product has not been assessed for dogs weighing less than 2.5 kg. For these animals use only according to the benefit/risk assessment by the responsible veterinarian.
Danish: Sikkerhed og effekt af dette produkt er ikke blevet vurderet for hunde, der vejer under 2,5 kg.
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.
Danish: Hos hunde med akut lungeødem, der kræver intensiv behandling bør injicérbare lægemidler overvejes før oral behandling med diuretika påbegyndes.
English: > 11.5 to 15
Danish: > 11,5 til 15
English: > 30 to 40
Danish: > 30 til 40
English: Isemid 1 mg chewable tablets Isemid 2 mg chewable tablets Isemid 4 mg chewable tablets torasemide
Danish: Isemid 1 mg tyggetabletter Isemid 2 mg tyggetabletter Isemid 4 mg tyggetabletter torasemid
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 "Adverse reactions").
Danish: Efter behandling af raske hunde doseret med 3 og 5 gange max dosis i 5 på hinanden følgende dage, efterfulgt af 177 daglige administrationer med 3 og 5 gange højeste terapeutiske vedligeholdelsesdosis, blev histopatologiske forandringer i nyrerne (interstitiel inflammation, udvidelse af nyretubuli, subkapsulære cyster) observeret i tillæg til de effekter som observeredes ved behandling med anbefalet dosis (se afsnittet ”Bivirkninger”).
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
Danish: Torasemid udøver sin primære effekt i det tykke ascenderende ben af Henles slynge, hvor interaktion med Na
English: In a clinical field study, renal insufficiency, an increase in renal blood parameters, haemoconcentration and alterations in electrolyte levels (chloride, sodium, potassium, phosphorus, magnesium, calcium) were very commonly observed.
Danish: I et klinisk feltstudie var nedsat nyrefunktion, øgning af nyretal i blodet, hæmokoncentration og ændringer i elektrolytniveauer (klorid, natrium, kalium, fosfor, magnesium, calcium) meget almindelige.
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på fremstillerne ansvarlig for batchfrigivelse
English: This veterinary medicinal product may cause increased urination, thirst and/or gastrointestinal disturbances and/or hypotension and/or dehydration if ingested.
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr Dette produkt kan give øget vandladning, tørst og/eller forstyrrelser i mavetarmsystemet og/eller hypotension og/eller dehydrering ved indtagelse.
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).
Danish: Efter behandling af raske hunde doseret med 3 og 5 gange max dosis i 5 på hinanden følgende dage, efterfulgt af 177 daglige administrationer med 3 og 5 gange højeste terapeutiske vedligeholdelsesdosis, blev histopatologiske forandringer i nyrerne (interstitiel inflammation, udvidelse af nyretubuli, subkapsulære cyster) observeret i tillæg til de effekter som observeredes ved behandling med anbefalet dosis (se pkt.
English: Oblong brown scored tablets.
Danish: Aflange brune tabletter med delekærv.
English: PACKAGE SIZE
Danish: Pakningsstørrelser
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 "Contraindications" and "Adverse reactions").
Danish: Det anbefales at monitorere nyrefunktionen regelmæssigt (måling af koncentration af urinstof og kreatinin i blodet, såvel som uriprotein-kreatinin (UPC) forholdet, væskebalancen samt elektrolytniveauer i serum før og under behandling i overensstemmelse med den ansvarlige dyrlæges benefit-risk vurdering (se afsnittene ”kontraindikationer” og ”Bivirkninger”).
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.
Danish: Hvis langvarig behandling med dette lægemiddel er nødvendig, skal behandlingen fortsættes med den lavest effektive dosis, når tegn på kronisk hjertesvigt er under kontrol og patienten er stabil.
English: 30 chewable tablets 90 chewable tablets
Danish: 30 tyggetabletter 90 tyggetabletter
English: Chewable tablet.
Danish: Tyggetablet.
English: Pharmacotherapeutic group: Cardiovascular system, high-ceiling diuretics, plain sulfonamides ATC vet code: QC03CA04
Danish: ATCvet-kode: QC03CA04
English: In dogs presenting with acute pulmonary oedema requiring emergency treatment, the use of injectable medicinal products should be considered first before commencing oral diuretic therapy.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr Hos hunde med akut pulmonært ødem, der kræver intensiv behandling, bør injicérbare lægemidler overvejes før oral behandling med diuretika påbegyndes.
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).
Danish: Den initiale dosis eller vedligeholdelsesdosen kan midlertidigt øges ved mere udtalt pulmonært ødem, dvs. ved udvikling af alveolært ødem (se pkt.
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).
Danish: Det anbefales at monitorere nyrefunktionen regelmæssigt (måling af koncentration af urinstof og kreatinin i blodet såvel som urinprotein-kreatinin (UPC) forholdet), væskebalancen samt elektrolytniveauer i serum før og under behandling i overensstemmelse med den ansvarlige dyrlæges benefit-risk vurdering (se pkt.
English: Isemid 1 mg chewable tablets for dogs (2.5-11.5 kg) Isemid 2 mg chewable tablets for dogs (> 11.5-23 kg) Isemid 4 mg chewable tablets for dogs (> 23-60 kg)
Danish: Isemid 1 mg tyggetabletter til hunde (2,5-11,5 kg) Isemid 2 mg tyggetabletter til hunde (> 11,5-23 kg) Isemid 4 mg tyggetabletter til hunde (> 23-60 kg)
English: Isemid 1 mg chewable tablets for dogs (2.5-11.5 kg) Isemid 2 mg chewable tablets for dogs (> 11.5-23 kg) Isemid 4 mg chewable tablets for dogs (> 23-60 kg) torasemide
Danish: Isemid 1 mg tyggetabletter til hunde (2,5-11,5 kg) Isemid 2 mg tyggetabletter til hunde (> 11,5-23 kg) Isemid 4 mg tyggetabletter til hunde (> 23-60 kg) torasemid
English: PACKAGE LEAFLET Isemid 1 mg chewable tablets for dogs (2.5-11.5 kg) Isemid 2 mg chewable tablets for dogs (> 11.5-23 kg) Isemid 4 mg chewable tablets for dogs (> 23-60 kg)
Danish: INDLÆGSSEDDEL: Isemid 1 mg tyggetabletter til hund (2,5-11,5 kg) Isemid 2 mg tyggetabletter til hund (> 11,5-23 kg) Isemid 4 mg tyggetabletter til hund (> 23-60 kg)
English: 2 mg of torasemide
Danish: 2 mg torasemid
English: Store out of reach of animals.
Danish: Opbevares utilgængeligt for dyr.
English: Chewable tablet
Danish: Tyggetablet
English: 4 mg of torasemide
Danish: 4 mg torasemid
English: Children and adolescents (< 18 years)
Danish: Børn og unge (< 18 år)
English: Unopened bottle 3 years.
Danish: Uåbnet flaske 3 år.
English: The changes will completely resolve within a few weeks.
Danish: Ændringerne er fuldstændigt forsvundet inden for få uger.
English: Usually you will not experience any symptoms when these changes occur.
Danish: Normalt vil du ikke få nogen symptomer, når disse ændringer opstår.
English: This is always done by a pharmacist or a nurse and not by yourself.
Danish: Dette gøres altid af en apoteker eller sygeplejerske - ikke af dig selv.
English: Decrease of your sense of touch (hypaesthesia), and loose or watery stools (diarrhoea).
Danish: nedsat følesans (hypæstesi) og løs eller vandig afføring (diaré).
English: Date of first authorisation: 07 September 2007 Date of latest renewal: 12 September 2012
Danish: Dato for første markedsføringstilladelse: 07 september 2007 Dato for seneste fornyelse: 12 september 2012
English: Follow-up time was 28 days.
Danish: Opfølgningsperioden var på 28 dage.
English: Not known (cannot be estimated from the available data).
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
English: Distribution and biotransformation
Danish: Fordeling og biotransformation
English: Keep the bottle in the outer carton in order to protect from light.
Danish: Opbevar flasken i den ydre karton for at beskytte mod lys.
English: Do not use this medicine if you are pregnant.
Danish: Brug ikke denne medicin, hvis du er gravid.
English: It was stated that the patient had been exposed to more light than permitted for the trial.
Danish: Det blev angivet, at patienten havde været eksponeret for mere lys, end det var tilladt i forsøget.
English: It is not known whether Gliolan will harm an unborn baby.
Danish: Det vides ikke, om Gliolan kan skade et ufødt barn.
English: Therefore, Gliolan should not be used during pregnancy.
Danish: Gliolan bør derfor ikke anvendes under graviditet.
English: • If you have a heart disease or had heart disease in the past, you should tell your doctor.
Danish: • Hvis du har en hjertesygdom eller tidligere har haft en hjertesygdom, bør du fortælle det til din læge.
English: The pharmacist or nurse will calculate the exact dose you need and the amount of the solution (in ml) you have to drink.
Danish: Apotekeren eller sygeplejersken vil beregne den nøjagtige dosis, som du har brug for, og den mængde opløsning (i ml), som du skal drikke.
English: Long-term in vivo carcinogenicity studies have not been conducted.
Danish: Der er ikke foretaget undersøgelser af karcinogeniciteten in vivo på længere sigt.
English: 5-ALA is eliminated quickly with a terminal half-life of 1-3 hours.
Danish: 5-ALA elimineres hurtigt med en terminal halveringstid på 1-3 timer.
English: The difference was statistically significant using the chi-square test (p=0.015).
Danish: Forskellen var statistisk signifikant med anvendelse af en chi test (p = 0,015).
English: Gliolan with food and drink
Danish: Brug af Gliolan sammen med mad og drikke
English: Pack sizes: 1, 2 and 10 bottles.
Danish: Pakningsstørrelser: 1, 2 og 10 flasker.
English: − A training course for neurosurgeons which is aimed at risk minimisation and to support safe and effective use for the medicinal product.
Danish: − Et uddannelseskursus for neurokirurger, der har til formål at minimere risikoen og understøtte en sikker og virkningsfuld anvendelse af lægemidlet.
English: This medicine is a powder that must be first mixed with drinking water before use.
Danish: Denne medicin er et pulver, som først skal blandes med drikkevand inden brug.
English: The cardiovascular effects seen are considered to be related to the intravenous route of administration.
Danish: De kardiovaskulære virkninger anses for at være forbundet med den intravenøse administrationsvej
English: Side effects are divided into the following two categories:
Danish: Bivirkningerne er opdelt i to kategorier:
English: Follow-up time comprised at least 180 days after administration.
Danish: Opfølgningsperioden var mindst 180 dage efter indgivelse.