FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have forgotten to apply your transdermal patch at the right time, apply it as soon as you remember, and tell your doctor as soon as possible before your chemotherapy treatment.
Danish: Hvis du har glemt at påsætte dit depotplaster på det rigtige tidspunkt, skal du sætte det på, så snart du husker på det, og fortælle det til lægen snarest muligt før din behandling med kemoterapi.
English: Try to avoid wearing the transdermal patch in water for long periods of time.
Danish: Forsøg at undgå at have depotplastret på i vand i lange perioder.
English: - Contact with water during bathing or showering will not change the way SANCUSO works.
Danish: - Kontakt med vand ved karbadning eller brusebadning vil ikke ændre den måde, SANCUSO virker på.
English: Adverse reactions reported for SANCUSO System Organ Class
Danish: Bivirkninger rapporteret for SANCUSO Systemorganklasse
English: Do not use this medicine if you are pregnant unless your doctor has specifically recommended it. Stop breast-feeding while wearing the patch.
Danish: Du bør ikke anvende dette lægemiddel, hvis du er gravid, medmindre lægen specifikt har anbefalet det. Du skal ophøre med at amme, mens du har plastret på.
English: Adverse reactions are presented in order of decreasing seriousness within each frequency grouping.
Danish: Bivirkningerne er opstillet efter faldende sværhedsgrad inden for hver gruppering af hyppighed.
English: After intravenous injection, approximately 12% of the dose is excreted unchanged in the urine of healthy subjects in 48 hours.
Danish: Efter intravenøs injektion udskilles ca. 12 % af dosis uændret i urinen hos raske personer i løbet af 48 timer.
English: You must talk to a doctor if you do not feel better or if you feel worse after the first day of chemotherapy.
Danish: Du skal kontakte lægen, hvis du ikke har det bedre, eller hvis du har det værre efter den første dags kemoterapi.
English: Skin reactions at the site of application, such as irritation, itching or redness are uncommon and may affect up to 1 in 100 people.
Danish: Hudreaktioner på applikationsstedet, såsom irritation, kløe eller rødme, er ikke almindelige og kan forekomme hos op til 1 ud af 100 personer.
English: The newly applied transdermal patch should be removed in line with the timing recommended above.
Danish: Det nyapplicerede depotplaster skal fjernes i henhold til de tidsmæssige anbefalinger ovenfor.
English: The most commonly reported adverse reaction in clinical studies was constipation, occurring in approximately 8.7% of patients.
Danish: Den mest almindeligt rapporterede bivirkning i kliniske studier var forstoppelse, der forekom hos ca. 8,7 % af patienterne.
English: Carcinogenicity studies showed no special hazard for humans when used at the recommended dose.
Danish: Karcinogenicitetsstudier viser ingen speciel risiko for mennesker, når det bruges med den anbefalede dosis.
English: - Phenobarbital, used to treat epilepsy.
Danish: - Phenobarbital, anvendes til at behandle epilepsi.
English: The transdermal patch should not be placed on skin that is red, irritated or damaged.
Danish: Depotplastret må ikke placeres på hud, der er rød, irriteret eller beskadiget.
English: Do not put SANCUSO on areas that have been treated with creams, oils, lotions, powders or other skin products that could keep the transdermal patch from sticking well to your skin.
Danish: Sæt ikke SANCUSO på områder, der er blevet behandlet med cremer, olier, lotioner, pudder eller andre hudprodukter, der kan forhindre, at depotplastret klæber godt på huden.
English: The recommended dose is one single transdermal patch.
Danish: Den anbefalede dosis er et enkelt depotplaster.
English: The known pharmacokinetic profile of the transdermal patch over the period of wear (7 days) was not affected.
Danish: Den kendte farmakokinetiske profil for depotplastret i løbet af den periode, det bæres (7 dage), blev ikke påvirket.
English: 78% of patients were white, with 12% Asian and 10% Hispanic/Latino.
Danish: 78 % af patienterne var kaukasiske med 12 % asiater og 10 % af latinsk oprindelse.
English: There are no data on the use of granisetron in pregnant women.
Danish: Der er ingen data fra anvendelse af granisetron til gravide kvinder.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel
English: This variability is similar to the known high variability in granisetron pharmacokinetics after oral or intravenous administration.
Danish: Denne variabilitet er sammenlignelig med den kendte store variabilitet i farmakokinetikken af granisetron efter oral eller intravenøs administration.
English: Press firmly making sure there is good contact with the skin, especially around the edges.
Danish: Tryk godt ned for at sikre en god kontakt med huden, især langs kanterne.
English: This medicine delivers the active substance slowly and constantly through your skin and into your blood stream for the duration that you are wearing the transdermal patch.
Danish: Dette lægemiddel leverer det aktive stof langsomt og konstant via huden og ind i blodbanen i den periode, du bærer depotplastret.
English: Preclinical data did not reveal any special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, reproductive toxicity and genotoxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, reproduktionstoksicitet og genotoksicitet.
English: Also some other medicines can affect the way SANCUSO works.
Danish: Andre lægemidler kan også påvirke den måde, SANCUSO virker på.
English: Alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased
Danish: Forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjet gammaglutamyltransferase
English: There is no specific antidote for granisetron.
Danish: Der findes ingen specifik antidot mod granisetron.
English: Continue to keep the application site covered for a further 10 days after removing the transdermal patch.
Danish: Fortsat med at holde applikationsstedet tildækket i yderligere 10 dage efter, at du fjerner depotplastret.
English: Granisetron is distributed with a mean volume of distribution of approximately 3 l/kg.
Danish: Granisetron distribueres med et gennemsnitligt fordelingsvolumen på ca. 3 l/kg.
English: Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP Hoofddorp, The Netherlands
Danish: Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP Hoofddorp, Holland
English: The used transdermal patch will still contain some granisetron and should be disposed of immediately as described in section 5.
Danish: Det brugte depotplaster vil stadig indeholde noget granisetron og skal straks bortskaffes som beskrevet i pkt.
English: There are no data on the effect of granisetron on human fertility.
Danish: Der er ingen data for virkningen af granisetron på human fertilitet.
English: Side effects with a frequency not known (cannot be estimated from available data): - allergic skin reactions.
Danish: Bivirkninger uden kendt hyppighed (kan ikke estimeres ud fra forhåndenværende data) - Overfølsomhedsreaktioner i huden.
English: The Multinational Association of Supportive Care in Cancer (MASCC) guidelines recommend the administration of dexamethasone with 5HT3 antagonist prior to chemotherapy.
Danish: Retningslinjer fra Multinational Association of Supportive Care in Cancer (MASCC) anbefaler administration af dexamethason sammen med 5HT3-antagonist før kemoterapi.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V*Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Do not re-use the transdermal patch after removal, see below for instructions on transdermal patch removal and disposal (see section 5).
Danish: Depotplastret må ikke anvendes igen efter, at det fjernes, se nedenfor for instruktioner om fjernelse og bortskaffelse af depotplastret (se pkt.
English: Granisetron is mainly metabolised to 7-hydroxygranisetron and 9'N-desmethylgranisetron.
Danish: Granisetron metaboliseres hovedsageligt til 7-hydroxygranisetron og 9'N-desmethylgranisetron.
English: CC was defined as no vomiting and/or retching, no more than mild nausea and no rescue medicine from the first administration until 24 hours after the start of the last day's administration of multi-day chemotherapy.
Danish: CC blev defineret som ingen opkastning og/eller opkastningsfornemmelser, ikke mere end let kvalme og ingen nødmedicin fra den første administration indtil 24 timer efter starten på den sidste dags administration af flerdags kemoterapi.
English: However, when administered in higher doses and over a prolonged period of time, the risk of carcinogenicity cannot be ruled out but with the short application period recommended for the transdermal delivery system, a carcinogenic risk for humans is not expected.
Danish: Når der administreres højere doser og i længere tid, kan risikoen for karcinogenicitet imidlertid ikke udelukkes, men med den korte applikationsperiode, der anbefales for det transdermale leveringssystem, forventes ingen karcinogen risiko for mennesker.
English: Appropriate observation of patients for serotonin syndrome-like symptoms is advised.
Danish: Det anbefales derfor at observere patienter for serotoninsyndromlignende symptomer.
English: The study was designed to show non-inferiority of SANCUSO to oral granisetron.
Danish: Studiet var designet til at vise SANCUSO's non-inferioritet i forhold til oral granisetron.
English: If the transdermal patch is lost or becomes damaged go back to your doctor.
Danish: Hvis depotplastret tabes eller beskadiges, skal du tage til lægen.
English: No differences in the metabolic profiles of granisetron were observed between the oral and transdermal uses.
Danish: Der blev ikke observeret nogen forskelle i de metaboliske profiler af granisetron mellem oral og transdermal anvendelse.
English: Following SANCUSO application, granisetron is absorbed slowly, with maximal concentrations reached between 24 and 48 hours.
Danish: Efter applikation af SANCUSO absorberes granisetron langsomt, og maksimale koncentrationer opnås efter 24-48 timer.
English: Rare side effects (may affect up to 1 in 1,000 people) are: - abnormal muscle movements (such as shaking, muscle rigidity and muscle contractions).
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer) er: - unormale muskelbevægelser (såsom rysten, muskelstivhed og muskelsammentrækninger).
English: Used transdermal patches still contain active ingredients, which may be harmful to others.
Danish: Anvendte depotplastre indeholder stadig aktivt stof, som kan være skadeligt for andre.
English: Each transdermal patch is packaged in a heat-sealed sachet composed of polyester-coated paper/aluminium/LLDPE.
Danish: Hvert depotplaster er pakket i et varmeforseglet brev bestående af polyester-overtrukket papir/aluminium/LLDPE.
English: The transdermal patch will still contain active substance following use.
Danish: Depotplastrene vil stadig indeholde det aktive stof efter brug.
English: Granisetron crosses intact skin into the systemic circulation by a passive diffusion process.
Danish: Granisetron krydser intakt hud og kommer ind i det systemiske kredsløb via en passiv diffusionsproces.
English: If you use more SANCUSO than you should, simply remove the extra patch(es) and contact your doctor.
Danish: Hvis du har brugt for meget SANCUSO, skal du blot fjerne det ekstra plaster/de ekstra plastre og kontakte lægen.
English: Consequently, SANCUSO is indicated for use in patients where oral anti-emetic administration is complicated by factors making swallowing difficult.
Danish: Som et resultat heraf er SANCUSO indiceret til brug hos patienter, hvor oral antiemetisk administration kompliceres af faktorer, der gør det svært at synke.
English: Radioligand binding studies have demonstrated that granisetron has negligible affinity for other receptor types, including 5HT1, 5HT2, 5HT4 and dopamine D2 binding sites.
Danish: Studier med radioligand-binding har vist, at granisetron har en ubetydelig affinitet for andre receptortyper, herunder 5HT1-, 5HT2-, 5HT4- og dopamin D2-bindingssteder.
English: No significant effect on QTc prolongation was observed for SANCUSO.
Danish: Der blev ikke observeret nogen signifikant virkning på QTc-forlængelse for SANCUSO.
English: Oral granisetron was administered daily for the duration of the chemotherapy regimen, one hour prior to each dose of chemotherapy.
Danish: Oral granisetron blev administreret dagligt under hele kemoterapi-programmet, én time før hver dosis kemoterapi.
English: Given the wide variability in pharmacokinetic parameters of granisetron and the good tolerance well above the recommended dose, dose adjustment in patients with functional hepatic impairment is not necessary.
Danish: I betragtning af den store variabilitet i farmakokinetiske parametre for granisetron og den gode tolerance langt over den anbefalede dosis, er det ikke nødvendigt at justere dosis hos patienter med funktionelt nedsat leverfunktion.
English: In particular, tell your doctor or nurse if you are taking the following medicines: - Paracetamol, used to treat pain.
Danish: Du skal især fortælle til lægen eller sundhedspersonalet, hvis du tager nogle af de følgende lægemidler: - Paracetamol, anvendes til smertebehandling.
English: Granisetron is a potent anti-emetic and highly selective antagonist of 5-hydroxytryptamine (5HT3 receptors).
Danish: Granisetron er et kraftigt antiemetikum og en meget selektiv antagonist mod 5-hydroxytryptamin (5HT3-receptorer).
English: Fertility was unaffected following granisetron treatment in rats.
Danish: Fertiliteten blev ikke påvirket efter behandling med granisetron hos rotter.
English: Concurrent administration of a single intravenous bolus of 0.01 mg/kg (maximum 1 mg) granisetron at the same time a SANCUSO transdermal patch was applied was investigated in healthy subjects.
Danish: Samtidig administration af en enkelt intravenøs bolus på 0,01 mg/kg (maksimum 1 mg) granisetron på samme tid, som SANCUSO depotplastret blev appliceret, blev undersøgt hos raske personer.
English: A pivotal, randomised, double-blind, double-dummy, multinational Phase III study compared the efficacy, tolerability and safety of SANCUSO with that of 2 mg oral granisetron once daily in the prevention of nausea and vomiting in a total of 641 patients receiving multi-day chemotherapy.
Danish: Et pivotalt, randomiseret, dobbeltblindt, dobbelt-dummy, multinationalt fase III-studie, der sammenlignede virkning, tolerabilitet og sikkerhed af SANCUSO med 2 mg oral granisetron én gang dagligt til forebyggelse af kvalme og opkastning hos i alt 641 patienter, der fik flerdags kemoterapi.
English: You can continue to shower and wash normally while wearing the transdermal patch.
Danish: Du kan fortsat tage brusebade og vaske dig normalt, når du benytter depotplastret.
English: Talk to your doctor if you want to remove the patch before the end of your chemotherapy treatment course (up to 7 days).
Danish: Kontakt din læge, hvis du ønsker at fjerne plastret, før kemoterapiforløbet er slut (op til 7 dage).
English: In clinical trials with SANCUSO, application site reactions were reported which were generally mild in intensity and did not lead to discontinuation of use.
Danish: I kliniske studier med SANCUSO blev der rapporteret reaktioner på applikationsstedet, som generelt var lette i intensitet og ikke førte til seponering.
English: Anti-emetic activity was assessed from the first administration until 24 hours after the start of the last day's administration of the ME or HE chemotherapy regimen.
Danish: Antiemetisk aktivitet blev vurderet fra den første administration indtil 24 timer efter starten på den sidste dags administration af kemoterapi-programmet med ME eller HE.
English: The area you choose should not be oily, recently shaved or have any skin problems such as being injured (cut or scraped) or irritated (redness or a rash).
Danish: Det område, du vælger, må ikke være fedtet, barberet for nyligt eller have hudproblemer som skader (rifter eller afskrabning) eller irritation (rødme eller udslæt).
English: The effect of SANCUSO on QTc interval was specifically evaluated in a blinded, randomised, parallel, placebo and positive (moxifloxacin) controlled thorough QTc trial with SANCUSO in 240 adult male and female subjects.
Danish: Virkningen af SANCUSO på QTc-intervallet blev specifikt evalueret i et blindet, randomiseret, parallel, placebo- og positiv (moxifloxacin) kontrolleret grundigt QTc-studie med SANCUSO hos 240 voksne mandlige og kvindelige personer.
English: Assessment of serial ECGs in patients showed no QT prolongation and no change in ECG morphology.
Danish: Vurdering af serie-EKG'er hos patienter viste ingen QT-forlængelse og ingen ændring i EKG-morfologi.
English: If your arms are not suitable areas to apply the transdermal patch your doctor may ask you to put it on your abdomen.
Danish: Hvis dine arme ikke er hensigtsmæssige områder for depotplastret, kan lægen bede dig om at sætte det på maven.
English: This medicine may not work as well and/or may affect your skin if exposed to direct sunlight or the light from sunlamps or tanning beds.
Danish: Det kan være, at lægemidlet ikke virker så godt og/eller kan påvirke huden, hvis det udsættes for direkte sollys eller lys fra sollamper eller solarier.
English: In clinical studies conducted with SANCUSO, clearance in cancer patients was shown to be approximately half that of healthy subjects.
Danish: I kliniske studier, der blev udført med SANCUSO, blev det vist, at clearance hos cancerpatienter var ca. halvdelen af clearance hos raske personer.
English: Wash your hands after applying the transdermal patch.
Danish: Vask hænder efter placering af depotplastret.
English: Granisetron was not phototoxic when tested in vitro in a mouse fibroblast cell line.
Danish: Granisetron var ikke fototoksisk, når det testes in vitro i fibroblast cellelinjen hos mus.
English: If it is not possible to apply the transdermal patch to the arm, it can be applied to the abdomen.
Danish: Hvis det ikke er muligt at applicere depotplastret på armen, kan det appliceres på abdomen.
English: Matrix layer Acrylate-vinylacetate copolymer
Danish: Matrixlag Akrylat-vinylacetat-copolymer
English: In human subjects, hepatic enzyme induction by phenobarbital has led to an increase in total plasma clearance (approximately 25%) following intravenous administration of granisetron.
Danish: Hos mennesker har hepatisk enzyminduktion af phenobarbital ført til en forhøjelse i total plasmaclearance (ca. 25 %) efter intravenøs administration af granisetron.
English: You may see mild redness on the skin where the transdermal patch is removed.
Danish: Du kan evt. se en let rødme på huden, hvor depotplastret blev fjernet.
English: The population randomised into the trial included 48% males and 52% females aged 16 to 86 years receiving moderately emetogenic (ME) or highly emetogenic (HE) multi-day chemotherapy.
Danish: Populationen, der blev randomiseret i dette studie inkluderede 48 % mænd og 52 % kvinder i alderen 16 til 86 år, der fik moderat emetogen (ME) eller højemetogen (HE) flerdags kemoterapi.
English: While application of the heat pad was associated with a minor and transient increase in the transdermal patch flux during the period of heat pad application, no overall increase in granisetron exposure was observed when compared to a control group.
Danish: Selvom applikationen af varmepuden var forbundet med en mindre og forbigående forøgelse i depotplastrets flux i løbet af den periode, varmepuden var sat på, blev der ikke observeret en samlet forøgelse af eksponering for granisetron, sammenlignet med en kontrolgruppe.
English: In the event of a transdermal patch becoming completely or partially detached, the original transdermal patch should be reattached in the same position using medical tape (if necessary).
Danish: Hvis depotplastret løsnes helt eller delvist, skal det oprindelige depotplaster appliceres igen på samme sted med medicinsk tape (hvis det er nødvendigt).
English: When tested for skin sensitising potential in guinea pigs, SANCUSO showed a low potential for irritancy.
Danish: Under tests for potentialet for hudsensibilisering hos marsvin viste SANCUSO et lavt potentiale for irritation.
English: Granisetron has been shown to block both sodium and potassium channels, which could affect cardiac depolorisation and repolarisation and therefore PR, QRS, and QT intervals.
Danish: Granisetron har vist sig at blokere både natrium- og kaliumkanalerne, som kunne påvirke hjertets depolarisering og repolarisering og dermed PR-, QRS- og QT-intervallerne.
English: In vitro studies using human liver microsomes indicate that CYP1A1 is the major enzyme responsible for the 7-hydroxylation of granisetron, whereas CYP3A4 contributes to 9'desmethylation.
Danish: In vitro-studier med humane levermikrosomer indikerer, at CYP1A1 er det primære enzym, der er ansvarlig for 7-hydroxylationen af granisetron, hvorimod CYP3A4 bidrager til 9'desmethylation.
English: Other ingredients: acrylate-vinylacetate copolymer, polyester, siliconised polyester.
Danish: Øvrige indholdsstoffer: Akrylat-vinylacetat-copolymer, polyester, silikoniseret polyester.
English: If this is not possible, a new transdermal patch should be applied on the opposite arm.
Danish: Hvis dette ikke er muligt, skal et nyt depotplaster appliceres på den anden arm.
English: In studies in healthy subjects, no evidence of any interaction has been indicated between granisetron and benzodiazepines (lorazepam), neuroleptics (haloperidol) or anti-ulcer medicinal products (cimetidine).
Danish: I studier af raske personer er der ikke evidens for nogen interaktioner mellem granisetron og benzodiazepiner (lorazepam), neuroleptika (haloperidol) eller anti-ulcus lægemidler mod mavesår (cimetidin).
English: After transdermal patch application, the apparent granisetron plasma half-life in healthy subjects was prolonged to approximately 36 hours due to the slow absorption rate of granisetron through the skin.
Danish: Efter applikation af depotplastret var den tilsyneladende halveringstid i plasma hos raske personer forlænget til ca. 36 timer på grund af granisetrons langsomme absorptionshastighed gennem huden.
English: - Ketoconazole, used to treat fungal infections.
Danish: - Ketoconazol, anvendes til at behandle svampeinfektioner.
English: In the pivotal SANCUSO study, the concomitant use of corticosteroids, e.g. dexamethasone, was permitted provided it was part of the chemotherapy regimen.
Danish: I det pivotale SANCUSO-studie var samtidig anvendelse af kortikosteroider, f.eks. dexamethason, tilladt under forudsætning af, at det var en del af kemoterapi-programmet.
English: Be careful not to stick the transdermal patch to itself and avoid touching the sticky side of the transdermal patch.
Danish: Vær forsigtig, så depotplastret ikke klæber sammen, og undgå at berøre den klæbende side af depotplastret.
English: A study in cloned human cardiac ion channels has shown that granisetron has the potential to affect cardiac repolarisation via blockade of hERG potassium channels.
Danish: Et studie af klonede humane ionkanaler fra hjertet har vist, at granisetron har potentialet til at påvirke hjertets repolarisation via blokade af hERG kaliumkanaler.