FrancophonIA/ELRC3.0 huggingface dataset:
English: ALPROLIX 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU eftrenonacog alfa.
Danish: ALPROLIX 1000 IU pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 1000 IU eftrenonacog alfa.
English: After reconstitution, each mL of solution for injection contains approximately 50 IU eftrenonacog alfa.
Danish: Efter rekonstitution indeholder hver ml injektionsvæske ca. 50 IU eftrenonacog alfa.
English: General disorders and administration site conditions Fatigue Infusion site pain
Danish: Træthed Smerter på infusionsstedet
English: After reconstitution, each mL of solution for injection contains approximately 400 IU eftrenonacog alfa.
Danish: Efter rekonstitution indeholder hver ml injektionsvæske ca. 400 IU eftrenonacog alfa.
English: After reconstitution, each mL of solution for injection contains approximately 200 IU eftrenonacog alfa.
Danish: Efter rekonstitution indeholder hver ml injektionsvæske ca. 200 IU eftrenonacog alfa.
English: After reconstitution, each mL of solution for injection contains approximately 600 IU eftrenonacog alfa.
Danish: Efter rekonstitution indeholder hver ml injektionsvæske ca. 600 IU eftrenonacog alfa.
English: After reconstitution, each mL of solution for injection contains approximately 100 IU eftrenonacog alfa.
Danish: Efter rekonstitution indeholder hver ml injektionsvæske ca. 100 IU eftrenonacog alfa.
English: Cmax (IU/dL)
Danish: Dosis (IU/kg)
English: Protect product from direct sunlight.
Danish: Beskyt injektionsvæsken mod direkte sollys.
English: The prepared solution will be clear to slightly opalescent and colourless.
Danish: Den fremstillede injektionsvæske skal være klar eller let opaliserende og farveløs.
English: Dose
Danish: Hjerte
English: Ask your pharmacist how to throw away medicines you no longer use.
Danish: Bortskaf al ubrugt injektionsvæske på passende vis. Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: Do not use solutions that are cloudy or have deposits.
Danish: Injektionsvæsker, der er uklare eller indeholder udfældninger, må ikke anvendes.
English: The solution should appear clear to slightly opalescent and colourless.
Danish: Injektionsvæsken skal være klar eller let opaliserende og farveløs.
English: Avoid eye contact.
Danish: Undgå øjenkontakt.
English: … or onto a small amount of food.
Danish: … eller på en lille mængde foder.
English: The absolute bioavailability after oral administration was found to be 33%.
Danish: Den absolutte biotilgængelighed efter oral administration blev bestemt til 33%.
English: Semintra is an oral solution and is well accepted by most cats.
Danish: Semintra er en oral opløsning og accepteres godt af de fleste katte.
English: The terminal elimination half-life (t1/2) ranged from 7.3 hours to 8.6 hours, with mean value 7.7 hours.
Danish: Den terminale eliminationshalveringstid (t1/2) lå i intervallet fra 7,3 timer til 8,6 timer med en gennemsnitsværdi på 7,7 timer.
English: ATCvet code: QC09CA07
Danish: ATCvet-kode: QC09CA07
English: DATE OF REVISION OF THE TEXT
Danish: 10. DATE FOR ÆNDRING AF TEKSTEN
English: The product is to be administered once daily directly into the mouth or with a small amount of food.
Danish: Produktet skal administreres oralt en gang dagligt direkte i munden eller sammen med en lille mængde foder.
English: No pharmacological activity has been shown for the conjugate.
Danish: Der er ikke påvist farmakologisk aktivitet for konjugatet.
English: See section “Contraindications”.
Danish: Se punktet ”Kontraindikationer”.
English: In case of accidental eye contact, rinse eyes with water.
Danish: I tilfælde af utilsigtet øjenkontakt skylles øjnene med vand.
English: The CVMP agreed that the periodic safety update report (PSUR) cycle would be re-started at 6 months, 12 months and 24 months following authorisation of the extension, as detailed in the CVMP assessment report.
Danish: CVMP besluttede, at cyklus for periodiske sikkerhedsopdateringer (PSUR) skal genstartes 6 måneder, 12 måneder og 24 måneder efter godkendelse af udvidelsen som beskrevet i CVMP vurderingsrapporten.
English: Active substance: Telmisartan
Danish: Aktivt stof: Telmisartan
English: People with hypersensitivity to telmisartan or other sartans/ARBs should avoid contact with the veterinary medicinal product.
Danish: Personer med overfølsomhed over for telmisartan eller andre sartaner/ARB bør undgå kontakt med veterinærlægemidlet.
English: No clinically relevant accumulation was observed following multiple dose administration once daily for 21 days.
Danish: Der observeredes ingen klinisk relevant akkumulering efter administration af flere doser en gang dagligt i 21 dage.
English: The safety and efficacy of telmisartan for the management of systemic hypertension above 200 mmHg has not been investigated.
Danish: Sikkerhed og virkning af telmisartan til behandling af systemisk hypertension over 200 mmHg er ikke undersøgt.
English: Due to the combination of these pharmacodynamic properties, telmisartan is an appropriate treatment for cats with concomitant hypertension and CKD.
Danish: Som følge af kombinationen af disse farmakodynamiske egenskaber, er telmisartan en velegnet behandling til katte med samtidig hypertension og CKD.
English: As determined by AUC, food consumption does not affect the overall extent of absorption of telmisartan.
Danish: Det er ud fra AUC fastlagt, at foderindtagelse ikke påvirker det samlede omfang af absorption af telmisartan.
English: The target SBP range is between 120 and 140 mmHg.
Danish: Det ønskede SBT interval ligger mellem 120 og 140 mmHg.
English: If the SBP increases over the course of the disease the daily dose may be increased again up to 2 mg/kg.
Danish: Hvis SBT forhøjes som følge af sygdommen, kan den daglige dosis atter forhøjes op til 2 mg/kg.
English: EXP {month/year} Once opened use by ....
Danish: EXP {måned/år} Efter åbning: anvendes inden ....
English: The safety and efficacy of telmisartan in such patients has not been investigated.
Danish: Sikkerhed og virkning af telmisartan er ikke undersøgt hos sådanne patienter.
English: Treatment of systemic hypertension in cats.
Danish: Behandling af systemisk hypertension hos katte.
English: In vitro studies in human, dog, mouse and rat plasma showed a high plasma protein binding (>99.5%), mainly to albumin and α-1-acid glycoprotein.
Danish: In vitro-forsøg med menneske-, hunde-, muse- og rotteplasma viste en høj plasmaproteinbinding (> 99,5%), overvejende til albumin og α-1-syreglycoprotein.
English: The glucuronidation resulted in the formation of the 1-O-acylglucuronide metabolite of telmisartan.
Danish: Glucuronideringen resulterede i dannelsen af telmisartans 1-O-acylglucuronidmetabolit.
English: Benzalkonium chloride Hydroxyethylcellulose Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Maltitol
Danish: Benzalkoniumchlorid Hydroxyethylcellulose Natriumhydroxid (til pH-justering) Saltsyre (til pH-justering) Maltitol
English: Push down and turn cap to open the bottle.
Danish: Pres låget ned og drej det rundt for at åbne flasken.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary products.
Danish: Uforligeligheder I mangel på uforligelighedsstudier, må dette lægemiddel ikke blandes med andre veterinære produkter.
English: Do not use during pregnancy or lactation (see also section 4.7).
Danish: Bør ikke anvendes ved drægtighed eller diegivning (se også punkt 4.7).
English: No significant gender effect was seen.
Danish: Der observeredes ingen signifikant forskel mellem kønnene under behandling.
English: In cats with hypertension it is good clinical practice to regularly monitor blood pressure.
Danish: Hos katte med hypertension er det god klinisk praksis regelmæssigt at monitorere blodtryk.
English: Elevated liver enzymes have been very rarely observed and values normalised within a few days following cessation of therapy.
Danish: Forhøjede leverenzymer er meget sjældent observeret, og værdierne normaliserede sig i løbet af nogle få dage efter ophør af behandlingen.
English: Shelf life of the veterinary medicinal product as packaged for sale (30 ml or 100 ml): 3 years.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning (30 ml eller 100 ml): 3 år.
English: The solution should be given using the measuring syringe provided in the package.
Danish: Opløsningen skal gives ved brug af doseringssprøjten, der findes i pakken.
English: For both, Cmax-values, and AUC-values, a dose proportional increase over the dose range from 0.5 mg/kg to 3 mg/kg was observed.
Danish: For både Cmax-værdier og AUC-værdier observeredes en dosisproportional stigning over dosisintervallet fra 0,5 mg til 3 mg/kg.
English: The receptor binding is long lasting due to the slow dissociation of telmisartan from the AT1 receptor binding site.
Danish: Receptorbindingen er langvarig på grund af den langsomme dissociation af telmisartan fra AT1-receptorbindingsstedet.
English: After administration of the veterinary medicinal product, close the bottle tightly with the cap, wash the measuring syringe with water and let it dry.
Danish: Efter administration af det veterinære lægemiddel lukkes flasken tæt med hætten, vask doseringssprøjten med vand og lad den tørre.
English: When using this product in cats with severe kidney disease, it is advisable to monitor renal function (plasma creatinine concentration).
Danish: Når dette produkt anvendes til katte med svær nyresygdom tilrådes det at monitorere nyrefunktionen (koncentrationen af kreatinin i plasma).
English: Do not use during pregnancy and lactation (see section 4.3).
Danish: Må ikke anvendes under drægtighed og diegivning (Se punkt 4.3).
English: Separate the dosing syringe from the bottle.
Danish: Tag doseringssprøjten af flasken.
English: After oral administration, telmisartan is almost exclusively excreted in the faeces mainly as the unchanged active substance.
Danish: Efter oral administration udskilles telmisartan næsten udelukkende i fæces hovedsaligt som den uforandrede aktive substans.
English: Mild and transient gastrointestinal signs such as vomiting and diarrhoea associated with product administration have been observed commonly in a clinical study.
Danish: Milde og forbigående gastrointestinale symptomer såsom opkastning og diarre associeret med administration af produktet er almindeligt set i et klinisk studie.
English: Substances acting on the RAAS may lead to a reduction in glomerular filtration rate and worsening renal function in cats with severe kidney disease.
Danish: Stoffer med virkning på RAAS kan nedsætte den glomulære filtrationsrate og forværre nyrefunktionen hos katte med svær nyresygdom.
English: Pull the plunger out until the end of the plunger corresponds to the amount needed in ml.
Danish: Træk stemplet ud indtil stemplets ende befinder sig ud for det nødvendige antal ml.
English: Telmisartan is highly lipophilic and has rapid membrane permeability kinetics, which facilitates easy distribution into tissue.
Danish: Telmisartan er stærkt lipofil og har en hurtig membranpermeabilitetskinetik, hvilket letter distributionen ind i væv.
English: The following mild and transient gastrointestinal signs have rarely been observed in a clinical study (in order of decreasing frequency): mild and intermittent regurgitation, vomiting, diarrhoea or soft faeces.
Danish: Følgende milde og forbigående gastrointestinale symptomer er sjældent observeret i kliniske studier (efter faldende hyppighed): mild og intermitterende regurgitation,opkastning, diarré eller blød afføring.
English: From in vitro and ex vivo studies with feline liver microsomes it can be concluded that telmisartan is effectively glucuronidated in the cat.
Danish: Fra in vitro- og ex vivo-forsøg med kattelevermikrosomer kan det konkluderes, at telmisartan glucuronideres effektivt i katte.
English: Effects associated with stimulation of the AT2 receptor such as vasodilatation, natriuresis and inhibition of inappropriate cell growth are not suppressed.
Danish: Virkninger forbundet med stimulering af AT2-receptoren, såsom vasodilatation, natriurese og hæmning af uønsket cellevækst er ikke undertrykt.
English: Red blood cell count should be monitored during therapy.
Danish: Antallet af røde blodlegemer bør overvåges under behandlingen.
English: To avoid contamination, use the provided syringe only to administer Semintra.
Danish: For at undgå forurening bør den medfølgende sprøjte kun benyttes til Semintra.
English: Reduction of proteinuria associated with chronic kidney disease (CKD) in cats.
Danish: Reduktion af proteinuri associeret med kronisk nyresygdom (CKD) hos katte.
English: See section “Pregnancy and lactation”.
Danish: Se punkt ”Drægtighed og laktation”.
English: Hypokalaemia is associated with CKD, however telmisartan does not affect potassium excretion, as shown in the clinical field trial in cats.
Danish: Hypokalæmi er forbundet med CKD, telmisartan påvirker imidlertid ikke kaliumekskretionen som påvist ved kliniske feltforsøg med katte.
English: The combination of telmisartan with such agents may lead to additive hypotensive effects or may alter renal function.
Danish: Kombinationen af telmisartan med sådanne midler kan medføre additive hypotensive virkninger eller ændring af nyrefunktionen .
English: Telmisartan selectively binds to the AT1 receptor and does not show affinity for other receptors, including AT2 or other less characterised AT receptors.
Danish: Telmisartan binder selektivt til AT1-receptoren og fremviser ikke affinitet til andre receptorer, herunder AT2 eller andre mindre karakteriserede AT-receptorer.
English: Push the plunger to empty the contents of the syringe directly into the mouth of the cat
Danish: Tryk stemplet i bund, så indholdet i sprøjten tømmes ud direkte i kattens mund …
English: Pull the plunger out until the end of the plunger corresponds to your cat´s body weight in kilograms.
Danish: Træk stemplet ud, indtil stemplets ende befinder sig ud for din kats legemsvægt i kg.
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, angiotensin II antagonists, plain.
Danish: Farmakoterapeutisk gruppe: Midler med virkning på renin-angiotensin-systemet, angiotensin IIantagonister, usammensatte
English: Each bottle is closed with an LDPE plug-in adapter and a tamper-proof child resistant closure.
Danish: Hver flaske er lukket med en LDPE-adapter og et forseglet, børnesikret låg.
English: Attach the dosing syringe to the plug-in adapter of the bottle by gently pushing.
Danish: Fastgør doseringssprøjten på adapteren på flasken ved at presse forsigtigt.
English: Carton for 30 ml and 100 ml
Danish: Karton til 30 ml og 100 ml
English: Due to the mode of action of the veterinary medicinal product, transient hypotension (low blood pressure) may occur.
Danish: Som følge af veterinærlægemidlets virkningsmekanisme kan der forekomme forbigående hypotension (lavt blodtryk).
English: The syringe fits onto the bottle and has a kg-body weight scale.
Danish: Sprøjten passer på flasken og har en kg-legemsvægt-skala.
English: The dosage of telmisartan should be reduced if systolic blood pressure (SBP) is consistently lower than 120 mmHg or if there are concurrent signs of hypotension.
Danish: Doseringen af telmisartan bør reduceres, hvis det systoliske blodtryk (SBT) konsekvent er lavere end 120 mmHg, eller hvis der samtidig er tegn på hypotension.
English: EXP {month/year} Once opened use within 6 months.
Danish: EXP {måned/år} Anvendes indenfor 6 måneder efter åbning.
English: The syringe fits onto the bottle and has a ml scale.
Danish: Sprøjten passer på flasken og har en ml skala.
English: Telmisartan displaces angiotensin II from its binding site at the AT1 receptor subtype.
Danish: Telmisartan fortrænger angiotensin II fra dets bindingssted på AT1-receptorundertypen.
English: The safety and efficacy of telmisartan has not been tested in cats under the age of 6 months.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr Sikkerheden ved og effekten af telmisartan er ikke blevet testet hos katte, der er under 6 måneder gamle.
English: In a further clinical trial in cats with hypertension a reduction in mean systolic blood pressure was achieved with a dose of 2 mg/kg.
Danish: I endnu et klinisk forsøg hos katte med forhøjet blodtryk blev et fald i middelværdien for systolisk blodtryk opnået ved en dosis på 2 mg/kg.
English: Disposal: read package leaflet.
Danish: Affald: Læs indlægssedlen.
English: In a European clinical field study, adverse events categorised as renal disorder/insufficiency (includes cases of chronic renal failure, elevated creatinine and/or blood urea nitrogen) were recorded in 3.6% of telmisartan-treated cats and 1% of placebo-treated cats.
Danish: I et europæisk klinisk feltstudie rapporteredes bivirkninger kategoriseret som nyresygdom/nyreinsuffiens (inklusiv tilfælde af kronisk nyresvigt, forhøjet kreatinin og/eller BlodUrea- Nitrogen) hos 3,6 % af katte behandlet med telmisartan og 1 % af katte behandlet med placebo.
English: PSURs:
Danish: PSUR´er:
English: The initial recommended dose is 2 mg telmisartan/kg body weight (0.2 ml/kg body weight).
Danish: Den anbefalede indledende dosis er 2 mg telmisartan/kg legemsvægt (0,2 ml/kg legemsvægt).
English: The recommended dose is 1 mg telmisartan/kg body weight (0.25 ml/kg body weight).
Danish: Den anbefalede dosis er 1 mg telmisartan/kg legemsvægt (0,25 ml/kg legemsvægt).
English: Marketing authorisation holder and manufacturer responsible for batch release Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
English: Telmisartan is metabolised by conjugation to the glucuronide of the parent compound.
Danish: Telmisartan metaboliseres ved glucuronidkonjugering af moderforbindelsen.
English: Telmisartan is an orally active and specific angiotensin II receptor (subtype AT1) antagonist which causes a dose-dependent decrease in mean arterial blood pressure in mammalian species, including the cat.
Danish: Telmisartan er en oralt aktiv og specifik angiotensin II-receptor (subtype AT1)-antagonist, der forårsager et dosisafhængigt fald i middelarterieblodtrykket hos pattedyr, herunder katten.
English: Following oral administration of telmisartan to cats, plasma-concentration-time curves of the parent compound are characterised by rapid absorption, with maximum plasma concentrations (Cmax) achieved after 0.5 hours (tmax).
Danish: Efter oral administration af telmisartan til katte er plasmakoncentration-tid-kurver for moderforbindelsen kendetegnet ved hurtig absorption, hvor maksimale plasmakoncentrationer (Cmax) opnås efter 0,5 time (tmax).
English: It is good clinical practice to monitor the blood pressure of cats receiving Semintra which are under anaesthesia.
Danish: Det er god klinisk praksis at monitorere blodtrykket hos katte, der får Semintra i forbindelse med anæstesi.
English: One HDPE bottle filled with 35 ml.
Danish: En HDPE flaske fyldt med 35 ml.
English: Shelf life after first opening of the bottle: 6 months.
Danish: Opbevaringstid efter første åbning af beholderen: 6 måneder.
English: Telmisartan does not exhibit any partial agonist activity at the AT1 receptor.
Danish: Telmisartan fremviser ingen partiel agonistaktivitet på AT1-receptoren.
English: Following oral administration of 1 mg/kg body weight telmisartan to cats, plasma-concentration-time curves of the parent compound are characterised by rapid absorption, with maximum plasma concentrations (Cmax) achieved after 0.5 hours (tmax).
Danish: Efter oral administration af 1 mg telmisartan/kg legemsvægt til katte er plasmakoncentration-tidkurver for moderforbindelsen kendetegnet ved hurtig absorption, hvor maksimale plasmakoncentrationer (Cmax) opnås efter 0,5 time (tmax).
English: One HDPE bottle filled with 30 ml or 100 ml.
Danish: En HDPE flaske fyldt med 30 ml eller 100 ml.
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 anvendte veterinærlægemidler, samt affald heraf bør destrueres i henhold til lokale retningslinier
English: Pack sizes of one plastic bottle filled with 30 ml or one plastic bottle filled with 100 ml.
Danish: Pakningsstørrelser med en plastikflaske fyldt med 30 ml eller en plastikflaske fyldt med 100 ml.
English: 35 ml 1 measuring syringe
Danish: 35 ml 1 doseringssprøjte
English: Stimulation of the AT1 receptor is responsible for pathologic effects of angiotensin II in the kidney and other organs associated with angiotensin II such as vasoconstriction, retention of sodium and water, increased aldosterone synthesis, organ remodelling and proteinuria.
Danish: Stimulering af AT1-receptoren er ansvarlig for de patologiske effekter af angiotensin II i nyren og andre organer, der er forbundet med angiotensin II, såsom vasokonstriktion, retention af natrium og vand, forhøjet aldosteronsyntese, organremodellering og proteinuri.
English: Stimulation of the AT1 receptor is responsible for pathologic effects of angiotensin II in the kidney and other organs associated with angiotensin II such as vasoconstriction, retention of sodium and water, increased aldosterone synthesis and organ remodelling.
Danish: Stimulering af AT1-receptoren er ansvarlig for de patologiske effekter af angiotensin II i nyren og andre organer, der er forbundet med angiotensin II, såsom vasokonstriktion, retention af natrium og vand, forhøjet aldosteronsyntese og organremodellering.
English: In a clinical trial in cats with chronic kidney disease, a reduction in proteinuria was seen within the first 7 days after the start of treatment.
Danish: I et klinisk forsøg med katte med kronisk nyresygdom observeredes en reduktion i proteinuri inden for de første 7 dage efter start af behandlingen.
English: In a clinical trial in cats with chronic kidney disease, a reduction in proteinuria was seen within the first 7 days after the start of treatment with 1 mg/kg.
Danish: I et klinisk forsøg med katte med kronisk nyresygdom observeredes en reduktion i proteinuri inden for de første 7 dage efter start af behandling med 1 mg/kg.
English: No drug-drug interactions are known from available data in cats with CKD for the use of telmisartan and other medicinal products that interfere with RAAS (such as ARBs or ACEis).
Danish: Der er ingen kendte lægemiddelinteraktioner fra tilgængelige data om katte med CKD ved brug af telmisartan og andre lægemidler, der påvirker RAAS (f.eks. ARB og ACEi).
English: Clear, colourless to yellowish viscous solution.
Danish: Klar, farveløs til gullig,viskøs opløsning.
English: If SBP is below the target or if there are concurrent signs of hypotension, please refer to the “Special warnings” section.
Danish: Hvis SBT ligger under det ønskede interval, eller hvis der er aktuelle tegn på hypotension, henvises der til afsnit 4.5 ”Særlige advarsler”.
English: The safety of Semintra has not been established in breeding, pregnant or lactating cats.
Danish: Sikkerheden ved Semintra til avlskatte, drægtige eller lakterende katte er ikke blevet fastlagt.
English: After 4 weeks, the dosage of telmisartan may be reduced in cats with systolic blood pressure (SBP) of less than 140 mmHg (in 0.5 mg/kg increments) at the discretion of the veterinarian.
Danish: Efter 4 uger kan doseringen af telmisartan efter dyrlægens skøn reduceres (i 0,5 mg/kg intervaller) til katte med systolisk blodtryk (SBT) på mindre end 140 mmHg.
English: Pregnant women should take special care to avoid contact with the product because substances acting on the RAAS, such as Angiotensin Receptor Blockers (ARBs) and ACE inhibitors (ACEis), have been found to affect the unborn child during pregnancy in humans.
Danish: Gravide kvinder bør tage særlige forholdsregler for at undgå kontakt med produktet, da substanser med virkning på RAAS, såsom angiotensin receptor blokkere (ARB) samt ACE hæmmere (ACEi), har vist sig at have effekt på fosteret ved graviditet hos mennesker.
English: The combination of agents targeting the RAAS may alter renal function.
Danish: Kombinationsbehandling af lægemidler, der påvirker RAAS kan ændre nyrefunktionen.