FrancophonIA/ELRC3.0 huggingface dataset:
English: It is expected that in CYP2C19 poor metabolisers or in patients receiving concomitantly strong CYP2C19 inhibitors (see section 4.5), nelfinavir plasma levels would be elevated whereas levels of tert-butyl hydroxy nelfinavir would be negligible or non-measurable.
Danish: Hos personer hvor CYP2C19 metaboliserer dårligt eller hos patienter, som samtidigt får stærke CYP2C19-hæmmere (se pkt.
English: Saquinavir 1200 mg single dose (nelfinavir 750 mg TID X 4 days)
Danish: Saquinavir 1200 mg enkeltdosis (nelfinavir 750 mg 3 gange daglig i 4 dage)
English: • Table 3: if you give the medicine three times a day, you will give 25-35 mg nelfinavir each time for each kg of body weight.
Danish: • Tabel 3: Hvis du giver lægemidlet tre gange daglig, skal du give 25-35 mg nelfinavir
English: which is an ester, theoretically corresponds to maximally 5.9 mg of sucrose when fully - Contains aspartame (E951): 20.0 mg of aspartame per gram of oral powder.
Danish: - Indeholder aspartam (E951): 20,0 mg aspartam pr. gram oralt pulver.
English: Patients older than 13 years: the recommended dose of VIRACEPT 250 mg film-coated tablets is 1250 mg (five tablets) twice a day (BID) or 750 mg (three tablets) three times a day (TID) by mouth.
Danish: Patienter over 13 år: Den anbefalede dosering af VIRACEPT 250 mg filmovertrukne tabletter er 1250 mg (fem tabletter) to gange daglig (BID) eller 750 mg (tre tabletter) tre gange dagligt (TID) Effekten af et BID-regime (to gange daglig), sammenlignet med et TID-regime (3 gange daglig), er primært undersøgt hos patienter, som ikke tidligere har fået proteasehæmmere (se pkt.
English: n=21 n=22 n=23
Danish: 3,1 gange 2,3 gange n=23
English: NAME OF THE MEDICINAL PRODUCT VIRACEPT 50 mg/g oral powder.
Danish: LÆGEMIDLETS NAVN VIRACEPT 50 mg/g oralt pulver.
English: • Table 2: if you give the medicine two times a day, you will give 50-55 mg nelfinavir each time for each kg of body weight.
Danish: • Tabel 2: Hvis du giver lægemidlet to gange daglig, skal du give 50-55 mg nelfinavir
English: NAME OF THE MEDICINAL PRODUCT Viracept 250 mg film-coated tablets Nelfinavir
Danish: LÆGEMIDLETS NAVN Viracept 250 mg filmovertrukne tabletter
English: Combination with other medicinal products: Caution is advised whenever VIRACEPT is coadministered with agents that are inducers or inhibitors and/or substrates of CYP3A4; such combinations may require dose adjustment (see also sections 4.3 and 4.8).
Danish: Kombination med andre lægemidler: Der skal udvises forsigtighed når VIRACEPT administreres samtidig med stoffer, som er induktorer eller hæmmere og/eller substrater for CYP3A4.
English: Taking this medicine • Take Viracept with a meal.
Danish: • Tag Viracept med et måltid.
English: EXPIRY DATE
Danish: Observerede data LOCF
English: Coadministration of nelfinavir and a strong inhibitor of CYP3A, ketoconazole, resulted in a 35 % increase in nelfinavir plasma AUC.The changes in nelfinavir concentrations are not considered clinically significant and no dose adjustment is needed when ketoconazole and nelfinavir are co-administered.
Danish: Samtidig administration af nelfinavir og en kraftig CYP3Ahæmmer, ketoconazol, resulterede i en 35 % stigning i nelfinavirs plasma AUC.
English: This helps make your medicine work as well as it can.
Danish: Det gør at dit lægemiddel virker bedre.
English: The VIRACEPT suspension should be taken with a meal.
Danish: Tag Viracept med et måltid.
English: Specific dose recommendations for nelfinavir cannot be made based on the results of this study.
Danish: Baseret på dette studie kan der ikke opstilles særlige dosisrekommendationer.
English: Methadone AUC may be decreased when co-administered with nelfinavir; therefore upward adjustment of methadone dose may be required during concomitant use with nelfinavir.
Danish: Methadons AUC kan falde ved samtidig administration af nelfinavir.
English: Rare (affect less than 1 in 1000 people):
Danish: Sjældne (forekommer hos mellem 1 og 10 ud af 10.000 patienter):
English: NAME OF THE MEDICINAL PRODUCT Viracept 50 mg/g oral powder Nelfinavir
Danish: LÆGEMIDLETS NAVN Viracept 50 mg/g oralt pulver
English: • Bone disease (osteonecrosis).
Danish: • Knoglesygdom (knoglenekrose).
English: No important differences in safety or tolerability were observed between the BID and TID dosing groups, with the same proportion of patients in each arm experiencing adverse events of any intensity, irrespective of relationship to trial medication.
Danish: Procentvis var der i begge arme lige mange patienter med bivirkninger, uanset sværhedsgrad og uanset
English: Substrates for CYP3A4: Co-administration is contraindicated with the following agents that are substrates for CYP3A4 and that have narrow therapeutic windows: terfenadine, astemizole, cisapride, amiodarone, quinidine, ergot derivatives, pimozide, oral midazolam, triazolam, alfuzosin, and sildenafil when used to treat pulmonary arterial hypertension (see section 4.3).
Danish: Substrater for CYP3A4: Samtidig administration er kontraindiceret med følgende forbindelser, som er substrater for CYP3A4, og som har et snævert terapeutisk indeks: Terfenadin, astemizol, cisaprid, amiodaron, quinidin, sekalealkaloider, pimozid, oral midazolam, triazolam, alfuzosin samt sildenafil, ved behandling af pulmonal arteriel hypertension (se pkt.
English: At 48 weeks, approximately 75 % of the patients treated with nelfinavir 750 mg TID plus zidovudine and lamivudine remained below the level of detection of the assay (< 400 copies/ml); mean increase in CD4 cell counts was 198 cells/mm3 at 48 weeks in this group.
Danish: Efter 48 uger var 75 % af patienterne, som fik 750 mg nelfinavir tre gange daglig sammen med zidovudin og lamivudin stadig under prøvens detektionsgrænse (< 400 kopier/ml).
English: Kcal
Danish: Udslæt
English: White Scoop
Danish: Hvid måleske
English: Common (affect less than 1 in 10 people):
Danish: Meget almindelige (forekommer hos flere end 1 ud af 10 patienter):
English: Excipients:
Danish: Leverinsufficiens:
English: Powder with water, milk, formula, soy formula, soy milk, or dietary supplements
Danish: Pulver med vand, mælk, modermælkserstatning, sojamodermælkserstatning, sojamælk eller kosttilskud
English: Osteonecrosis: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART).
Danish: Dog anses ætiologien for at være multifaktoriel (omfattende anvendelse af kortikosteroider, alkoholforbrug, svær immunosuppression, højere Body Mass Index (BMI)).
English: Dose to be administered three times a day to children aged 3 to 13 Recommended number of tablets at each meal
Danish: Dosis som skal gives tre gange daglig, til børn mellem 3 og 13 år, som vejer Samlet antal tabletter per dag
English: Nelfinavir may lead to decreased AUC of phenytoin; therefore phenytoin concentrations should be monitored during concomitant use with nelfinavir.
Danish: Nelfinavir kan forårsage et nedsat AUC for phenytoin.
English: Methadone 80 mg + 21 mg qd > 1 month (Nelfinavir 1250mg bid x 8 days
Danish: Analgetika Methadon 80 mg + 21 mg 1 gang
English: Uncommon (affect less than 1 in 100 people):
Danish: Almindelige (forekommer hos mellem 1 og 10 ud af 100 patienter):
English: Dose to be administered three times a day to children aged 3 to 13
Danish: Dosis, som skal administreres tre gange daglig, til børn mellem 3 og 13
English: Do not take Viracept if:
Danish: Vær ekstra forsigtig med at tage Viracept:
English: Dose to be given two times a day to children aged 3 to 13
Danish: Dosis som gives to gange daglig til børn i alderen 3 til 13 år
English: Delavirdine 400 mg TID (Nelfinavir 750 mg TID)
Danish: Delavirdin 400 mg 3 gange daglig
English: Nevirapine
Danish: VIRACEPT
English: Sildenafil is contraindicated when coadministered with VIRACEPT (see contraindications).
Danish: VIRACEPT (se kontraindikationer)
English: France
Danish: Tyskland
English: DATE OF REVISION OF THE TEXT
Danish: TEKST PÅ ETIKET
English: 1 Protocol specified dose (actual dose range)
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE)
English: Each bottle contains 144 grams of powder and is supplied with a 1 gram scoop (white) and a 5 gram scoop (blue).
Danish: Hver flaske indeholder 144 gram pulver og leveres sammen med en 1 grams
English: St. John's wort, stop St. John's wort, check viral levels and if possible nelfinavir levels.
Danish: Hvis en patient allerede tager perikon, skal brug af perikon ophøre og virusmængden, og om muligt, nelfinavirkoncentrationer kontrolleres.
English: If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
Danish: Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: Mean CD4 cell counts at 24 weeks were increased by 150 and 95 cells/mm3 for the groups treated with nelfinavir 750 mg TID
Danish: Middel-CD4-celletallet efter 24 uger steg med hhv.150 og 95 celler/mm3i gruppen, der fik 750 mg nelfinavir tre gange daglig sammen med zidovudin og lamivudin sammenlignet med gruppen, der fik zidovudin og lamivudin.
English: Dose to be administered two times a day to children aged 3 to 13
Danish: Dosis, som gives to gange daglig til børn i alderen 3 til 13 år
English: • Feeling sick.
Danish: • Opsvulmet mave.
English: • Omeprazole (for ulcers in your stomach or gut)
Danish: • Omeprazol (mod mavesår)
English: Side effects in children
Danish: Bivirkninger
English: Co-administration with medicinal products with narrow therapeutic windows and which are substrates of CYP3A4 [e.g., terfenadine, astemizole, cisapride, amiodarone, quinidine, pimozide, triazolam, orally administered midazolam (for caution on parenterally administered midazolam, see section 4.5), ergot derivatives, lovastatin and simvastatin, alfuzosin, and sildenafil when used for treatment of pulmonary arterial hypertension, (for the use of sildenafil and other PDE-5 inhibitors in patients with erectile dysfunction, see section 4.5)].
Danish: Samtidig administration med lægemidler med snævre terapeutiske vinduer, og som er substrater for CYP3A4 [f.eks. terfenadin, astemizol, cisaprid, amiodaron, quinidin pimozid, triazolam, oralt administreret midazolam (vedrørende forsigtighedsregler ved parenteral administreret midazolam, se pkt.
English: Concomitant use of trazodone and VIRACEPT may increase plasma concentrations of trazodone.
Danish: VIRACEPT kan øge plasmakoncentrationen af trazodon.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 January 1998
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF
English: Analgesics
Danish: Analyse
English: • Wind.
Danish: Se pkt.
English: Signs of previous infections
Danish: Hvis du bemærker nogle symptomer på infektion,
English: Antidepressants Trazodone
Danish: Diarré Kvalme, flatulens
English: If you want to take the powder instead please see the Package Leaflet for Viracept 50 mg/g oral powder.
Danish: Se indlægssedlen for Viracept 50 mg/g oralt pulver, hvis du hellere vil tage pulveret i stedet for.
English: Packaging Content Package size
Danish: Indgivelsesvej Emballage Indhold Paknings størrelse
English: Pharmaceutical form
Danish: Lægemiddelform
English: Wash hands after use.
Danish: Vask hænder efter håndtering.
English: Date of first authorisation: 09/01/2019
Danish: Dato for første markedsføringstilladelse: 09/01/2019
English: In dogs, the plasma protein binding is > 98%.
Danish: Hos hunde er plasmaproteinbindingen >98%.
English: Temporary high dose
Danish: Midlertidig høj dosis
English: An increase in albumin serum concentration was observed.
Danish: En stigning i serumkoncentrationen af albumin blev observeret.
English: 2.5 to 4 > 4 to 6 > 6 to 8
Danish: 2,5 til 4 > 4 til 6 > 6 til 8
English: All strengths are available in the following pack sizes:
Danish: Alle styrker er tilgængelige i følgende pakningsstørrelser:
English: After this period, the dose should be reduced to the maintenance dose and the dog should be evaluated by the veterinarian in a few days.
Danish: Efter denne periode, bør dosen reduceres til vedligeholdelsesdosen og hunden bør tilses af dyrlægen indenfor et par dage.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton or blister pack after "EXP".
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på æsken eller blisterpakningen efter ”EXP”.
English: The renal lesions were still present at 28 days after the end of treatment.
Danish: Forandringerne i nyrerne vedblev i 28 dage efter endt behandling.
English: A large proportion of the dose (about 60%) is excreted in the urine as unchanged parent substance.
Danish: En stor del af dosis (ca. 60%) udskilles via urinen som uændret moderstof.
English: Consequently, the medicinal product can be administered with or without food.
Danish: Dermed kan dette lægemiddel administreres med og uden mad.
English: Each blister contains 10 tablets and is packed in a cardboard box.
Danish: Hver blister indeholder 10 tabletter og er pakket i en kartonæske.
English: The tablet can be divided into halves.
Danish: Tabletten kan deles i to halvdele.
English: Do not use in cases of dehydration, hypovolaemia or hypotension.
Danish: Bør ikke anvendes i tilfælde af dehydrering, hypovolæmi eller hypotension.
English: Two metabolites (a dealkylated and a hydroxylated metabolite) have been identified in urine.
Danish: To metabolitter (en dealkyleret og en hydroxyleret metabolit) er blevet identificeret i urin.
English: As torasemide increases thirst, dogs should have free access to fresh water.
Danish: Eftersom torasemid øger tørsten, bør hunde have fri adgang til vand.
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.
Danish: Efter oral administration af 0,2 mg torasemid/kg legemsvægt var den absolutte biotilgængelighed på ca. 99% baseret på plasmakoncentration-tid data og 93% baseret på urinkoncentration-tid data.
English: Ceva Santé Animale ZI Très le Bois 22600 Loudéac France
Danish: Ceva Santé Animale ZI Très le Bois 22600 Loudéac Frankrig
English: People with known hypersensitivity to torasemide, to sulfonamides or to any of the excipients should avoid contact with the veterinary medicinal product.
Danish: Personer med kendt overfølsomhed overfor torasemid, sulfonamider eller overfor nogen af hjælpestofferne bør undgå kontakt med veterinærlægemidlet.
English: Blister pack of polyamide/aluminium/PVC, thermo-sealed by an aluminium foil (each blister contains 10 tablets) and packaged in a cardboard box.
Danish: Blisterpakning af polyamid/aluminium/PVC, thermo-forseglet af aluminiumsfolie (hver blister indeholder 10 tabletter) og pakket i en kartonæske.
English: Number and strength of Isemid tablets to be administered Initial/Maintenance dose
Danish: Antal og styrke af Isemid tabletter som skal administreres Start/Vedligeholdelsesdosis
English: This veterinary medicinal product may cause hypersensitivity (allergic) reactions in persons that are sensitized to torasemide.
Danish: Dette veterinærlægemiddel kan forårsage overfølsomheds- (allergiske) reaktioner hos personer, der er sensibiliserede overfor torasemid.
English: Bodyweight (kg)
Danish: Hundens legemsvægt (kg)
English: Monitoring of glycaemia in diabetic animals is recommended prior to and during treatment.
Danish: Monitorering af blodglukoseniveau hos diabetiske dyr anbefales før og under behandling.
English: All strengths are available in pack sizes of 30 or 90 tablets.
Danish: Alle styrker er tilgængelige i pakningsstørrelser med 30 eller 90 tabletter.
English: The proportion of torasemide excreted in the urine is approximately the same in fasted or fed conditions (61% vs. 59% respectively).
Danish: Proportionen af torasemid, der udskilles i urinen er ca. den samme under fastende og fodrede forhold (61% kontra 59%, respektivt).
English: EU/2/18/232/001 (30 tablets 1 mg) EU/2/18/232/002 (90 tablets 1 mg) EU/2/18/232/003 (30 tablets 2 mg) EU/2/18/232/004 (90 tablets 2 mg) EU/2/18/232/005 (30 tablets 4 mg) EU/2/18/232/006 (90 tablets 4 mg)
Danish: EU/2/18/232/001 (30 tabletter 1 mg) EU/2/18/232/002 (90 tabletter 1 mg) EU/2/18/232/003 (30 tabletter 2 mg) EU/2/18/232/004 (90 tabletter 2 mg) EU/2/18/232/005 (30 tabletter 4 mg) EU/2/18/232/006 (90 tabletter 4 mg)
English: Torasemide has a more potent, longer-acting diuretic activity than furosemide.
Danish: Torasemid har mere potent, længerevarende diuretisk aktivitet end furosemid.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister
English: Torasemide may increase the risk of sulfonamide allergy.
Danish: Torasemid kan øge risikoen for sulfonamidallergi.
English: Cardboard box (90 tablets)
Danish: Kartonæske (90 tabletter)
English: Microscopic characteristics of the lesions suggest an ongoing repair process.
Danish: De mikroskopiske karakteristika af læsionerne antyder en kontinuerlig helingsproces.
English: Laboratory studies in rats and rabbits have shown foetotoxicity at maternotoxic doses.
Danish: Laboratoriestudier af rotter og kaniner har afsløret føtal toksicitet ved maternotoksiske doser.
English: These lesions may most likely be considered as a result of the pharmacodynamic effect (diuresis) and were not associated with evidence of glomerulosclerosis or interstitial fibrosis.
Danish: Læsionerne er sandsynligvis et resultat af den farmakodynamiske effekt (diurese) og var ikke associeret med tegn på glomerulosklerose eller interstitiel fibrose.
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.
Danish: Det diuretiske respons på torasemid kan øges over tid, ved gentagne doseringer især ved doser >0,2 mg/kg/dag; derfor bør hyppigere monitorering overvejes.
English: (0.26 to 0.40 mg/kg/day)
Danish: (0,26 til 0,40 mg/kg/dag)
English: As the safety of the product has not been established in the target species, the use of the product is not recommended during pregnancy, lactation and breeding animals.
Danish: Da lægemidlets sikkerhed ikke er blevet fastlagt hos målarten, anbefales brug under drægtighed, laktation eller hos avlsdyr, ikke.
English: The following table shows the dose adjustment scheme within the recommended dose range of 0.13 to 0.4 mg/kg/day:
Danish: Den følgende tabel viser dosisjustering indenfor det anbefalede dosisinterval på 0,13 til 0,4 mg/kg/dag:
English: Do not use concomitantly with other loop diuretics.
Danish: Bør ikke anvendes samtidigt med andre loop-diuretika.
English: Doses of 0.26 mg/kg and higher should only be administered for a maximum period of 5 days.
Danish: Doser på 0,26 mg/kg og højere bør kun administreres i en periode på max 5 dage.
English: (0.13 to 0.25 mg/kg/day)
Danish: (0,13 til 0,25 mg/kg/dag)
English: The parent substance is metabolised by the hepatic cytochrome P450 families 3A4 and 2E1, and to a lesser extent by 2C9.
Danish: Moderstoffet bliver metaboliseret af leverenzymet cytochrom P450-familierne 3A4 og 2E1 og i mindre grad af 2C9.
English: Torasemide should be used with caution in cases of diabetes mellitus.
Danish: Torasemid bør anvendes med forsigtighed hos hunde med diabetes mellitus.
English: The tablets are flavoured.
Danish: Tabletterne er tilsat smag.
English: Remaining tablet parts should be stored in the blister and be given at the next administration.
Danish: Tilbageværende tabletdele skal opbevares i blisterpakningen og anvendes ved næste administration.
English: Pack sizes of 30 or 90 tablets.
Danish: Pakningsstørrelse med 30 eller 90 tabletter.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Torasemide has a chemical structure between those of loop diuretics (such as furosemide) and Cl channel blockers.
Danish: I sin kemiske struktur ligger torasemid mellem loop-diuretika (såsom furosemid) og Cl kanalblokkere.
English: Concomitant use with NSAIDs, aminoglycosides or cephalosporins may increase the risk of nephrotoxicity and/or ototoxicity of those medicinal products.
Danish: Samtidig anvendelse af NSAID'er, aminoglykosider eller cefalosporiner kan øge risikoen for nefrotoksicitet og/eller ototoxicitet af disse lægemidler.
English: The recommended initial/maintenance dose is 0.13 to 0.25 mg torasemide/kg bodyweight/day, once daily.
Danish: Den anbefalede start/vedligeholdelsesdosis er 0,13 til 0,25 mg torasemid/kg legemsvægt/dag én gang dagligt.
English: Therefore diuretic activity of torasemide correlates better with the rate of torasemide excretion in the urine than with the concentration in the blood.
Danish: Af denne grund korrelerer den diuretiske aktivitet af torasemid bedre med graden af torasemidudskillelse i urinen end med koncentrationen i blodet.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (30 tablets)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Kartonæske (30 tabletter)
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.
Danish: Efter administration af 3 og 5 gange den højeste anbefalede terapeutiske dosis til raske hunde, observeredes nedsat appetit, hvilket i nogle tilfælde førte til vægttab.
English: Care should be exercised when administering torasemide with other highly plasma protein bound drugs.
Danish: Der bør udvises forsigtighed ved behandling med torasemid samtidig med andre lægemidler med høj plasmaproteinbinding.
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.
Danish: Efter en enkelt intravenøs dosis af 0,2 mg torasemid/kg legemsvægt hos hunde, var den gennemsnitlige totale clearance 22,1 ml/time/kg, med et gennemsnitligt fordelingsvolumen på 166 ml/kg og en gennemsnitlig terminal halveringstid på ca. 6 timer.
English: Keep the tablets out of the reach of animals in order to avoid any accidental ingestion.
Danish: Opbevar tabletterne utilgængeligt for dyr for at undgå utilsigtet indtag.
English: Consequently, water reabsorption from the collecting duct is inhibited and the volume of water on the luminal side is increased.
Danish: Som et resultat af dette, bliver reabsorption af vand fra samlerøret hæmmet og mængden af vand på luminal side stiger.
English: The dose should be adjusted to maintain patient comfort with attention to renal function and electrolytes status.
Danish: Dosen skal tilpasses i forhold til patientens velbefindende med fokus på nyrefunktion og elektrolytniveau.
English: For treatment of clinical signs related to congestive heart failure in dogs, including pulmonary oedema.
Danish: Til behandling af kliniske tegn forbundet med kongestiv hjerteinsufficiens hos hund, inklusiv pulmonært ødem.
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.
Danish: Behandlingsskift fra et alternativt loop-diuretikum til dette veterinærlægemiddel er ikke blevet undersøgt og et sådant skift bør kun indledes baseret på en benefit-risk vurdering udført af den ansvarlige dyrlæge.