FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor or nurse before using this treatment if any of the following applies to you: - if you have been told you have a heart disorder or disease - if you have pain in your stomach or your stomach is swollen - if you have problems with your kidneys or liver.
Danish: Kontakt lægen eller sundhedspersonalet, før du bruger dette lægemiddel, hvis noget af det følgende gælder for dig: - hvis du har fået at vide, at du har en hjertesygdom/hjertesygdomme - hvis du har mavesmerter, eller din mave er oppustet - hvis du har problemer med nyrerne eller leveren.
English: - However, the transdermal patch may become partially unstuck.
Danish: Depotplastret kan dog løsnes delvist.
English: When tested for potential photogenotoxicity in vitro in a Chinese hamster ovary (CHO) cell line, granisetron increased the percentage of cells with chromosome damage following photoirradiation.
Danish: Ved test af mulig fotogenotoksicitet in vitro i ovariecellelinjen hos en kinesisk hamster (CHO) forøgede granisetron procentdelen af celler med kromosomskader efter fotoirradiation.
English: After intravenous dosing, the mean plasma clearance ranged from 33.4 to 75.7 l/h in healthy subjects and from 14.7 to 33.6 l/h in patients with wide inter-subject variability.
Danish: Efter intravenøs dosering varierede den gennemsnitlige plasmaclearance fra 33,4 til 75,7 l/t hos raske personer, og fra 14,7 til 33,6 l/t hos patienter med stor variabilitet fra person til person.
English: If required, use surgical bandages or medical adhesive tape to keep the transdermal patch in place.
Danish: Hvis det er nødvendigt, kan du bruge operationsbandager eller medicinsk tape til at holde depotplastret på plads.
English: As granisetron is metabolised by hepatic cytochrome P450 active substance-metabolising enzymes (CYP1A1 and CYP3A4), inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of granisetron.
Danish: Da granisetron metaboliseres af hepatisk cytokrom P450 lægemiddelmetaboliserende enzymer (CYP1A1 og CYP3A4), kan inducere eller hæmmere af disse enzymer ændre clearance og dermed granisetrons halveringstid.
English: An assessment of transdermal patch adhesion in 621 patients receiving either active or placebo transdermal patches showed that less than 1% of transdermal patches became detached over the course of the 7 day period of transdermal patch application.
Danish: En vurdering af depotplastrets klæbeevne hos 621 patienter, der fik enten aktive depotplastre eller placebo, viste, at mindre end 1 % af depotplastrene løsnede sig i løbet af den 7-dages periode, hvor depotplastret var appliceret.
English: Based on the measure of residual content of the transdermal patch after removal, approximately 65% of granisetron is delivered resulting in an average daily dose of 3.1 mg per day.
Danish: Baseret på målinger af depotplastrets residualindhold efter fjernelse frigives ca. 65 % af granisetron, hvilket fører til en gennemsnitlig daglig dosis på 3,1 mg/dag.
English: Following consecutive application of two SANCUSO transdermal patches in healthy subjects, each for seven days, granisetron levels were maintained over the study period with evidence of minimal accumulation.
Danish: Efter to på hinanden følgende applikationer af SANCUSO depotplastre hos raske personer, hver af dem i syv dage, blev niveauet af granisetron vedligeholdt i løbet af studieperioden, kun med påvisning af minimal akkumulation.
English: Pharbil Waltrop GmbH (a subsidiary of NextPharma) Im Wirrigen 25
Danish: Pharbil Waltrop GmbH (et NextPharma datterselskab) Im Wirrigen 25
English: Remove the second half of the rigid plastic film and press the whole transdermal patch firmly in place with your fingers and smooth down.
Danish: Fjern den anden halvdel af den stive plasticfilm, og tryk hele depotplastret godt på plads med fingrene, og glat det ud.
English: 2132NP Hoofddorp The Netherlands Tel: +31 (0) 237200822
Danish: Tlf. +31 (0) 237200822
English: Activities such as swimming, strenuous exercise or using a sauna should be avoided.
Danish: Aktiviteter som svømning, hård træning eller sauna-besøg skal undgås.
English: Showering or washing
Danish: Brusebade eller afvaskning
English: It is not known how activities such as swimming, strenuous exercise or using a sauna or whirlpool, may affect this medicine.
Danish: Det er ukendt, hvordan aktiviteter såsom svømning, hård træning eller anvendelse af en sauna eller jacuzzi, kan påvirke lægemidlet.
English: This potentially may have clinical significance in patients with pre-existing arrhythmias or cardiac conduction disorders or patients who are being treated with antiarrhythmics or beta-blockers.
Danish: Dette kan evt. have en klinisk betydning hos patienter med eksisterende arytmi eller konduktionssygdomme i hjertet eller hos patienter, der behandles med antiarytmika eller betablokkere.
English: It is important to use this medicinal product as instructed by your doctor to prevent you feeling sick or being sick following your chemotherapy.
Danish: Det er vigtigt at bruge dette lægemiddel efter lægens anvisninger for at undgå, at du får kvalme eller kaster op efter din kemoterapi.
English: 5-HT3 receptor antagonists, such as granisetron, may be associated with arrhythmias or ECG abnormalities.
Danish: 5-HT3-receptorantagonister, såsom granisetron, kan være forbundet med arytmi eller unormale EKG'er.
English: Name and address of the manufacturer responsible for batch release PHARBIL Waltrop GmbH(a subsidiary of NextPharma) Im Wirrigen 25
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse PHARBIL Waltrop GmbH (et datterselskab af NextPharma) Im Wirrigen 25
English: Hypersensitivity to the active substance, to other 5-HT3 receptor antagonists or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof, andre 5-HT3-receptorantagonister eller over for et eller flere af hjælpestofferne anført i punkt 6.1.
English: Granisetron is cleared primarily by hepatic metabolism.
Danish: Granisetron udskilles primært via levermetabolismen.
English: Application site irritation Application site reactions (application site pain, application site pruritus, application site erythema, application site rash, application site irritation) *
Danish: Irritation på applikationsstedet Ikke almindelig Reaktioner på applikationsstedet (smerter på applikationsstedet, pruritus på applikationsstedet, erytem på applikationsstedet, udslæt på applikationsstedet, irritation på applikationsstedet)*
English: In a clinical study no differences were seen in the plasma pharmacokinetics of SANCUSO in male and female elderly subjects (≥ 65 years) compared with younger subjects (aged 18-45 years inclusive).
Danish: I et klinisk studie sås der ingen forskel i farmakokinetikken i plasma for SANCUSO hos mandlige og kvindelige ældre personer (≥ 65 år), sammenlignet med yngre personer (fra 18 til og med 45 år).
English: While you are wearing the transdermal patch you must keep it covered, e.g. under clothing, if there is a risk of exposure to sunlight or sunlamps.
Danish: Mens du har depotplastret sat på, skal du have det dækket til, f.eks. under beklædning, hvis der er en risiko for, at det udsættes for sollys eller sollamper.
English: Patients who are being treated with moderately or highly emetogenic chemotherapy may still experience vomiting despite treatment with antiemetic therapy, including SANCUSO.
Danish: Patienter, som behandles med moderat eller højemetogen kemoterapi, kan stadig opleve opkastning på trods af behandling med antiemetika, herunder SANCUSO.
English: Co-administration of intravenous 5-HT3 receptor antagonists with oral paracetamol in human subjects has been reported to result in a block in the analgesic effect via a pharmacodynamic mechanism.
Danish: Det er blevet rapporteret, at samtidig administration af intravenøs 5-HT3-receptorantagonist med oral paracetamol resulterer i en blokering af den analgetiske virkning via en farmakodynamisk mekanisme hos mennesker.
English: No dose adjustments are necessary for the elderly or patients with renal or hepatic impairment.
Danish: Ingen dosisjustering er nødvendig for ældre eller for patienter med nedsat nyre- eller leverfunktion.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: The medicine in the transdermal patch passes gradually through your skin into your body and, therefore, the patch is applied 1 to 2 days (24 to 48 hours) before the start of chemotherapy treatment.
Danish: Medicinen i depotplastret passerer gradvist gennem huden ind i kroppen, og derfor sættes plastret på 1-2 dage (24-48 timer), før behandlingen med kemoterapi påbegyndes.
English: Non-inferiority of SANCUSO versus oral granisetron was confirmed, with complete control (CC) achieved in 60.2% of patients in the SANCUSO arm and 64.8% of patients receiving oral granisetron in the per protocol set (difference -4.89%; 95% confidence interval -12.91% to +3.13%; n=284 transdermal patch, n=298 oral).
Danish: SANCUSO's non-inferioritet i forhold til oral granisetron blev bekræftet, og der blev opnået fuldstændig kontrol (CC) hos 60,2 % af patienterne i SANCUSO-armen og 64,8 % af patienterne, der fik granisetron i pr.-protokolsættet (forskel -4,89 %, 95 % konfidensinterval -12,91 % til +3,13 %, n=284 depotplaster, n=298 oral).
English: The active substance in SANCUSO is granisetron, which belongs to a group of medicines called antiemetics and antinauseants.
Danish: Det aktive stof i SANCUSO er granisetron, og det tilhører en gruppe lægemidler, der kaldes antiemetika (midler mod opkastning) og midler mod kvalme.
English: SANCUSO has no or negligible influence on the ability to drive and use machines.
Danish: SANCUSO påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Mean Cmax was 3.9 ng/ml (range 0.7 - 9.5 ng/ml), with a between subject variability of 77%.
Danish: Gennemsnitligt Cmax var 3,9 ng/ml (interval 0,7-9,5 ng/ml), med en variabilitet fra person til person på 77 %.
English: If you are being treated with chemotherapy that is moderately or highly capable of making you feel sick, you may still be sick despite treatment with anti-sickness medicine, including this medicine.
Danish: Hvis du behandles med kemoterapi, der i moderat eller høj grad er i stand til at give dig kvalme, kan du stadig opleve kvalme på trods af behandling med kvalmestillende medicin, herunder dette lægemiddel.
English: An initial peak in plasma concentrations of granisetron, attributable to the intravenous dose, was reached at 10 minutes post-administration.
Danish: En indledende maksimal plasmakoncentration af granisetron, som kan tilskrives den intravenøse dosis, blev nået 10 minutter efter-administration.
English: It is important to use this medicine during the whole length of your chemotherapy (up to 7 days) to prevent you feeling sick or being sick following your chemotherapy.
Danish: Det er vigtigt, at du bruger dette lægemiddel under hele kemoterapien (op til 7 dage) for at forhindre, at du får kvalme eller kaster op efter kemoterapien.
English: As a precautionary measure, it is preferable to avoid the use of SANCUSO during pregnancy.
Danish: For en sikkerheds skyld bør SANCUSO undgås under graviditeten.
English: Although, the clinical relevance of this finding is not completely clear, patients should be advised to cover the transdermal patch application site if there is a risk of exposure to sunlight throughout the period of wear and for 10 days following its removal (see section 4.4).
Danish: Selvom den kliniske relevans af disse fund ikke er fuldstændig klar, skal patienterne rådes til at dække applikationsstedet for depotplastret, hvis der er en risiko for eksponering for sollys i løbet af den periode, det bæres, og i 10 dage efter, at det fjernes (se pkt.
English: In a clinical study designed to assess granisetron exposure from SANCUSO in subjects with differing levels of body fat, using BMI as a surrogate measure for body fat, no differences were seen in the plasma pharmacokinetics of SANCUSO in male and female subjects with a low BMI [<19.5 kg/m2 (males), <18.5 kg/m2 (females)] and a high BMI (30.0 to 39.9 kg/m2 inclusive) compared to a control group (BMI 20.0 to 24.9 kg/m2inclusive).
Danish: I et klinisk studie, der var beregnet til at vurdere eksponeringen for granisetron fra SANCUSO hos personer med forskellige niveauer af kropsfedt, hvor BMI bruges som en surrogatmarkør for kropsfedt, blev der ikke set nogen forskel i SANCUSOs farmakokinetik i plasma hos mandlige og kvindelige personer med et lavt BMI [< 19,5 kg/m2 (mænd), < 18,5 kg/m2 (kvinder)] og et højt BMI (30,0 til og med 39,9 kg/m2), sammenlignet med en kontrolgruppe (BMI 20,0 til og med 24,9 kg/m2).
English: In vitro studies using human microsomes indicate that granisetron neither stimulates nor inhibits the cytochrome P450 enzyme system.
Danish: In vitro-studier med humane mikrosomer indikerer, at granisetron hverken stimulerer eller hæmmer cytokrom P450-enzymsystemet.
English: There is no clinical trial experience with SANCUSO and patients on chemotherapy for less than 3 consecutive days, or over multiple cycles of chemotherapy, or with high-dose chemotherapy prior to stem-cell transplantation.
Danish: Der er ingen erfaring fra kliniske studier med SANCUSO og patienter i behandling med kemoterapi i mindre end 3 sammenhængende dage eller i løbet af flere runder med kemoterapi eller med højdosis kemoterapi før stamcelletransplantation.
English: In clinical trials with SANCUSO, there were no treatment-related effects on heart rate or blood pressure.
Danish: I kliniske studier med SANCUSO var der ingen behandlingsrelaterede virkninger på pulsen og blodtrykket.
English: In a study designed to assess the effect of heat on the transdermal delivery of granisetron from SANCUSO in healthy subjects, a heat pad generating an average temperature of 42°C was applied over the transdermal patch for 4 hours each day over the 5 day period of wear.
Danish: I et studie beregnet til at vurdere virkningen af varme på den transdermale frigivelse af granisetron fra SANCUSO hos raske personer, blev der i 4 timer hver dag sat en varmepude på depotplastret, der genererede en gennemsnitlig temperatur på 42 °C, i løbet af de 5 dage, det blev båret.
English: Pharmacological studies have demonstrated that granisetron is effective against nausea and vomiting as a result of cytostatic therapy.
Danish: Farmakologiske studier har vist, at granisetron er effektivt mod kvalme og opkastning, forårsaget af cytostatisk behandling.
English: Do not use this medicine after the expiry date which is stated on the outer carton and the sachet after ‘EXP'.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på yderkartonen og brevet efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: - SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram.
Danish: - SSRI'er (selektive serotonin-genoptagelseshæmmere), der anvendes til at behandle depression og/eller angst, bl.a. fluoxetin, paroxetin, sertralin, fluvoxamin, citalopram og escitalopram.
English: Adverse reactions from clinical studies and spontaneous reports with SANCUSO are listed in the table below.
Danish: Bivirkninger fra kliniske studier og spontane rapporter med SANCUSO er opstillet i den nedenstående tabel:
English: Each transdermal patch is packed in a sachet and should be applied directly after the sachet has been opened.
Danish: Hvert depotplaster er pakket i et brev og skal appliceres umiddelbart efter, at brevet er åbnet.
English: Breast-feeding should be discontinued during treatment with SANCUSO.
Danish: Amning skal ophøre under behandling med SANCUSO.
English: Dosing as for adults (see sections 4.4 and 5.2).
Danish: 4.4 og 5.2).
English: If severe reactions, or a generalised skin reaction occur (e.g. allergic rash, including erythematous, macular, papular rash or pruritus), the transdermal patch must be removed.
Danish: Hvis der opstår svære reaktioner eller en generaliseret hudreaktion (f.eks. allergisk udslæt, herunder erytematøst, makulært, papuløst udslæt eller pruritus), skal depotplastret fjernes.
English: In patients with renal failure or hepatic impairment, the pharmacokinetics of granisetron were determined following a single 40 µg/kg intravenous dose of granisetron hydrochloride.
Danish: Hos patienter med nyresvigt eller nedsat leverfunktion blev granisetrons farmakokinetik bestemt efter en enkelt 40 µg/kg intravenøs dosis granisetronhydrochlorid.
English: Pharmacotherapeutic group: Antiemetics and antinauseants, serotonin (5HT3) antagonists, ATC code: A04AA02.
Danish: Farmakoterapeutisk klassifikation: Antiemetika og midler mod kvalme, (5HT3)-serotoninantagonister ATC-kode: A04AA02.
English: What you need to know before you use SANCUSO Do not use SANCUSO:
Danish: Det skal du vide, før du begynder at bruge SANCUSO Brug ikke SANCUSO:
English: - The active substance is granisetron.
Danish: - Aktivt stof: Granisetron.
English: The transdermal patch should not be cut into pieces.
Danish: Depotplastret må ikke klippes i mindre stykker.
English: No consistent gender effects on pharmacokinetics were observed in clinical studies with SANCUSO, with a large inter-individual variability reported in both sexes.
Danish: Der blev ikke observeret en konsistent kønsfordelt virkning i kliniske studier med SANCUSO, og en stor interindividuel variabilitet blev rapporteret hos begge køn.
English: Furthermore, no interaction has been observed between granisetron and emetogenic cancer therapies.
Danish: Desuden er der ikke blevet observeret nogen interaktion mellem granisetron og emetogene behandlinger mod cancer.
English: The majority of adverse reactions were mild or moderate in severity.
Danish: De fleste bivirkninger var af en let til moderat sværhedsgrad.
English: Patients must be advised to cover the transdermal patch application site, e.g. with clothing, if there is a risk of exposure to sunlight throughout the period of wear and for 10 days following its removal.
Danish: Patienter skal rådes til at dække applikationsstedet med depotplastret til, f.eks. med tøj, hvis der er en risiko for eksponering for sollys i løbet af hele den periode, plastret bæres, og i 10 dage efter, at det fjernes.
English: The release liner is removed prior to application.
Danish: Beskyttelsesfilmen fjernes før applikation.
English: In agreement with these data, no clinically relevant interactions have been reported in clinical studies with SANCUSO.
Danish: I overensstemmelse med disse data er der ikke rapporteret nogen klinisk relevante interaktioner i kliniske studier med SANCUSO.
English: SANCUSO transdermal patches did not show any potential for photoirritation or photosensitivity when tested in vivo in guinea-pigs.
Danish: SANCUSO depotplastre viser intet potentiale for fotoirritation eller fotosensitivitet, når det testes in vivo hos marsvin.
English: The granisetron transdermal patch was applied 24 to 48 hours prior to the first dose of chemotherapy, and kept in place for 7 days.
Danish: Granisetron depotplastret blev appliceret 24 til 48 timer før den første dosis kemoterapi og blev siddende i 7 dage.
English: After removing the transdermal patch you may find some sticky material is left on your skin.
Danish: Efter at depotplastret fjernes, kan noget af klæbematerialet være tilbage på huden.
English: In a pharmacokinetic study in healthy volunteers, where SANCUSO was applied for a period of 7 days, mean total exposure (AUC0-infinity) was 416 ng h/ml (range 55 - 1192 ng h/ml), with a between subject variability of 89%.
Danish: I et farmakokinetisk studie med raske frivillige, hvor SANCUSO blev appliceret i en periode på 7 dage, var den gennemsnitlige totale eksponering (AUC0-uendeligt) 416 ng t/ml (interval 55-1192 ng t/ml), med en variabilitet fra person til person på 89 %.
English: Bend the transdermal patch in the middle and remove one half of the rigid plastic film.
Danish: Depotplastret bukkes på midten, og den ene halvdel af den stive plasticfilm fjernes.
English: Use of concomitant corticosteroids
Danish: Samtidig anvendelse af kortikosteroider
English: SANCUSO is a transdermal (skin) patch used to prevent nausea (feeling sick) and vomiting (being sick) in adults receiving chemotherapy treatments (medicines to treat cancer) lasting 3 to 5 days and who have difficulty swallowing tablets (for example due to soreness, dryness or inflammation of the mouth or throat).
Danish: SANCUSO er et transdermalt plaster (på huden), som anvendes til at forebygge kvalme og opkastning hos voksne, der får behandling med kemoterapi (lægemidler til at behandle kræft), som varer 3-5 dage, og hvor patienterne har besvær med at sluge tabletterne (for eksempel på grund af ømhed, tørhed eller betændelse af mund eller hals).
English: As granisetron may reduce lower bowel motility, patients with signs of sub-acute intestinal obstruction should be monitored following its administration.
Danish: Da granisetron kan nedsætte motiliteten i den nedre del af tarmen, skal patienter med tegn på subakut tarmobstruktion overvåges efter administration.
English: If reattachment is not possible or the transdermal patch is damaged, a new transdermal patch should be applied in the same position as the original transdermal patch.
Danish: Hvis det ikke er muligt at sætte det fast igen, eller hvis depotplastret er beskadiget, skal et nyt depotplaster appliceres på samme sted som det oprindelige plaster.
English: - The transdermal patch may be affected by direct sunlight or exposure to sunlamps.
Danish: - Depotplastret kan påvirkes af direkte sollys, eller hvis det udsættes for sollamper.
English: No correlation between creatinine clearance and total clearance was observed in cancer patients, indicating no influence of renal impairment on the pharmacokinetics of granisetron.
Danish: Der blev ikke observeret nogen korrelation mellem kreatininclearance og total clearance hos cancerpatienter, hvilket indikerer, at den nedsatte nyrefunktion ikke har nogen indflydelse på granisetrons farmakokinetik.
English: - When you remove the transdermal patch, check your skin and tell your doctor if you notice a serious skin reaction (if your skin is very red, itchy or you notice any blisters).
Danish: - Når du fjerner depotplastret, skal du kontrollere huden og fortælle det til lægen, hvis du bemærker en alvorlig hudreaktion (hvis din hud er meget rød, klør, eller du bemærker vabler).
English: - The other ingredients are: - Transdermal patch adhesive: acrylate-vinylacetate copolymer - Backing layer: polyester - Rigid plastic film: siliconised polyester
Danish: - Øvrige indholdsstoffer: - Klæbemiddel i depotplastret: Akrylat-vinylacetat-copolymer - Bagsidelag: Polyester - Stiv plasticfilm: Silikoniseret polyester
English: Remove the transdermal patch and tell your doctor if you notice a serious skin reaction (if your skin is very red, itchy or you notice any blisters).
Danish: Fjern depotplastret og fortæl det til lægen, hvis du bemærker en alvorlig hudreaktion (hvis din hud er meget rød, klør, eller du bemærker vabler).
English: Fold the used transdermal patch in half with the sticky side inwards and dispose of it safely, out of the reach of children.
Danish: Fold depotplastret på midten med de klæbende sider indad, og bortskaf det på en sikker vis, utilgængeligt for børn.
English: Tell your doctor immediately if you develop constipation or if your stomach becomes painful or swollen.
Danish: Fortæl det straks til lægen, hvis du får forstoppelse, eller hvis du får mavesmerter eller oppustet mave.