FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety profile of SANCUSO is derived from controlled clinical trials and from post-marketing experience.
Danish: Viden om bivirkninger og sikkerhed ved brug af SANCUSO kommer fra kontrollerede kliniske studier samt fra erfaring efter markedsføring.
English: Contents of the pack and other information What SANCUSO contains
Danish: Pakningsstørrelser og yderligere oplysninger SANCUSO indeholder:
English: Remove the transdermal patch at least 1 day (24 hours) after completing your chemotherapy.
Danish: Fjern depotplastret mindst 1 dag (24 timer) efter, at du har gennemført din kemoterapi.
English: For serotonergic medicinal products (e.g. SSRIs and SNRIs), there have been reports of serotonin syndrome following concomitant use of 5-HT3 antagonists and other serotonergic medicinal products (including SSRIs and SNRIs).
Danish: For så vidt angår serotonerge lægemidler (f.eks. SSRI'er og SNRI'er), er der rapporteret om serotoninsyndrom efter samtidig administration af 5-HT3-antagonister og andre serotonerge lægemidler (herunder SSRI'er og SNRI'er).
English: Avoid these activities while wearing this transdermal patch.
Danish: Du bør undgå disse aktiviteter, mens du benytter depotplastret.
English: No clinically relevant interactions between SANCUSO and emetogenic cancer chemotherapies have been seen.
Danish: Der er ikke set nogen klinisk relevante interaktioner mellem SANCUSO og emetogen kemoterapi mod cancer.
English: In clinical interaction studies, aprepitant did not have clinically important effects on the pharmacokinetics of granisetron.
Danish: I kliniske interaktionsstudier havde aprepitant ingen klinisk vigtig virkninger på granisetrons farmakokinetik.
English: In vitro studies have shown that ketoconazole may inhibit the metabolism of granisetron via the cytochrome P450 3A isoenzyme family.
Danish: In vitro-studier har vist, at ketoconazol kan hæmme granisetrons metabolisme via cytokrom P450 3Aisoenzymfamilien.
English: Due to the gradual increase in plasma levels of granisetron following application of the transdermal patch, initial plasma levels at the start of chemotherapy may be lower than 2 mg oral granisetron and a slower onset of efficacy may therefore be observed.
Danish: Da der er en gradvis forhøjelse af plasmaniveauerne af granisetron efter applikation af depotplastret, kan de indledende plasmaniveauer være under 2 mg oral granisetron, når kemoterapien påbegyndes, og en langsommere start af virkning kan derfor observeres.
English: The sticky side of the transdermal patch is covered by a two-piece rigid plastic film.
Danish: Den klæbende side af depotplastret er dækket af et lag af en to-delt stiv plasticfilm.
English: - SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine.
Danish: - SNRI'er (serotonin-noradrenalingenoptagelseshæmmere), der anvendes til at behandle depression og/eller angst, bl.a. venlafaxin og duloxetin.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER BREV
English: Each carton contains one transdermal patch.
Danish: Hver karton indeholder 1 depotplaster.
English: Apply a single transdermal patch 24 to 48 hours before chemotherapy, as appropriate.
Danish: Sæt et enkelt depotplaster på 24 til 48 timer før kemoterapi, efter behov.
English: Uncommon side effects are: - headache, a feeling of “spinning” even when you are standing still (vertigo) - decreased appetite, weight loss - flushing (or redness) - feeling sick (nausea), retching, dry mouth - pain in your joints - swelling due to water retention (oedema) - changes in liver function tests (if you are having blood tests, tell the doctor or nurse that you have been given SANCUSO).
Danish: Ikke almindelige bivirkninger er: - hovedpine, en følelse af at “snurre rundt”, selv når du står stille (vertigo) - nedsat appetit, vægttab - rødme - kvalme, opkastningsfornemmelser, mundtørhed - smerter i leddene - hævelse, der skyldes vandophobning (ødem) - ændringer af leverfunktionsprøver (hvis du får taget blodprøver, skal du fortælle lægen eller sundhedspersonalet, at du har fået SANCUSO).
English: If you stop using SANCUSO
Danish: Hvis du holder op med at bruge SANCUSO
English: If you forget to use SANCUSO
Danish: Hvis du har glemt at bruge SANCUSO
English: There have been reports of serotonin syndrome with the use of 5-HT3 antagonists either alone, but mostly in combination with other serotonergic medicinal products (including selective serotonin reuptake inhibitors (SSRIs), and serotonin noradrenaline reuptake inhibitors (SNRIs).
Danish: Der er indberettet tilfælde af serotoninsyndrom ved brug af 5-HT3-antagonister enten alene eller, for det meste, sammen med andre serotonerge lægemidler (herunder selektive serotoningenoptagelseshæmmere (SSRI'er) og serotonin-noradrenalingenoptagelseshæmmere (SNRI'er)).
English: The transdermal patch should be applied to clean, dry, intact healthy skin on the outer part of the upper arm.
Danish: Depotplastret skal appliceres på ren, tør, intakt, rask hud på overarmens yderside.
English: SANCUSO transdermal patch is indicated in adults for the prevention of nausea and vomiting associated with moderately or highly emetogenic chemotherapy, for a planned duration of 3 to 5 consecutive days, where oral anti-emetic administration is complicated by factors making swallowing difficult (see section 5.1).
Danish: SANCUSO depotplaster er indiceret til voksne til at forhindre kvalme og opkastning i forbindelse med moderat eller højemetogen kemoterapi med en planlagt varighed på 3 til 5 sammenhængende dage, hvor oral administration af antiemetika er kompliceret af faktorer, der gør det svært at synke (se pkt.
English: The transdermal patch can be worn for up to 7 days depending on the duration of your chemotherapy treatment.
Danish: Depotplastret kan bæres i op til 7 dage, afhængigt af varigheden af din behandling med kemoterapi.
English: Other medicines and SANCUSO
Danish: Brug af anden medicin sammen med SANCUSO
English: However, no clinically relevant effects on ECG have been observed in clinical studies with SANCUSO, including a through QT study in 240 healthy subjects (section 5.1).
Danish: Imidlertid er der ikke blevet observeret nogen klinisk relevant virkning på EKG'er i kliniske studier med SANCUSO, herunder et grundigt QT-studie hos 240 raske personer (se pkt.
English: No clinically relevant effects have been observed in clinical studies with SANCUSO.
Danish: Der er ikke blevet observeret klinisk relevante virkninger i kliniske studier med SANCUSO.
English: In patients with hepatic impairment due to neoplastic liver involvement, total plasma clearance was approximately halved compared to patients without hepatic impairment.
Danish: der skyldes neoplastisk leverpåvirkning, var total plasmaclearance ca. halveret, sammenlignet med patienter uden nedsat leverfunktion.
English: If the transdermal patch starts to become unstuck, the same transdermal patch may be secured to the same area of skin.
Danish: Hvis depotplastret begynder at løsnes, kan det samme depotplaster fæstnes på det samme hudområde.
English: Release liner Siliconised polyester
Danish: Beskyttelsesfilm Silikoniseret polyester
English: No clinical studies have been performed specifically to investigate the pharmacokinetics of SANCUSO in patients with renal or hepatic impairment.
Danish: Der er ikke udført kliniske studier for specifikt at undersøge farmakokinetikken af SANCUSO hos patienter med nedsat nyre- eller leverfunktion.
English: No clear relationship between renal function (as measured by creatinine clearance) and granisetron clearance was identified in population PK modelling.
Danish: Der blev ikke identificeret noget klart forhold mellem nyrefunktion (målt ved kreatininclearance) og granisetronclearance i modeller af populationsfarmakokinetik.
English: Each 52 cm2 transdermal patch contains 34.3 mg of granisetron releasing 3.1 mg of granisetron per 24 hours.
Danish: Hvert 52 cm2 depotplaster indeholder 34,3 mg granisetron, der frigiver 3,1 mg granisetron pr. 24 timer.
English: After removal, the used transdermal patch should be folded firmly in half, adhesive side inwards and then discarded out of the reach of children.
Danish: Efter at depotplastret fjernes, skal det foldes grundigt på midten med den klæbende side indad og bortskaffes utilgængeligt for børn.
English: Gently wash the area with soap and water to remove it. Alcohol or other dissolving liquids such as nail polish remover may cause skin irritation and should not be used.
Danish: Alkohol eller andre opløsningsmidler som neglelakfjerner kan forårsage hudirritation og bør ikke anvendes.
English: Although no evidence of an increased incidence of adverse reactions have been observed in patients with renal or hepatic impairment receiving granisetron orally and intravenously, based on granisetron pharmacokinetics, a degree of caution must be exercised in this population.
Danish: Selvom der ikke er observeret evidens for en forøget forekomst af bivirkninger hos patienter med nedsat nyre- eller leverfunktion, der får granisetron oralt eller intravenøst, skal der på basis af farmakokinetikken af granisetron udvises en vis grad af forsigtighed hos denne population.
English: Backing layer Polyester
Danish: Bagsidelag Polyester
English: Package Leaflet: Information for the patient SANCUSO 3.1 mg/24 hours transdermal patch
Danish: Indlægsseddel: Information Til Patienten SANCUSO 3,1 mg/24 timer, depotplaster
English: - Do not cut the transdermal patch into smaller pieces.
Danish: - Depotplastret må ikke klippes i mindre stykker.
English: Showering or washing normally can be continued while wearing SANCUSO.
Danish: Der kan fortsat tages brusebade, og man kan vaske sig, mens SANCUSO bæres.
English: The transdermal patch should be removed a minimum of 24 hours after completion of chemotherapy.
Danish: Depotplastret skal fjernes mindst 24 timer, efter at kemoterapien er gennemført.
English: The transdermal patch can be worn for up to 7 days depending on the duration of the chemotherapy regimen.
Danish: Depotplastret kan bæres i op til 7 dage, afhængigt af varigheden af kemoterapi-programmet.
English: Put the transdermal patch on a clean, dry, healthy area of skin on the outside part of your upper arm.
Danish: Sæt depotplastret på et rent, tørt område med rask hud på overarmens yderside.
English: While holding the remaining half of the rigid plastic film, apply the transdermal patch to the skin on the outside part of your upper arm.
Danish: Mens der holdes fast i den anden halvdel af den stive plasticfilm, sættes depotplastret på huden på overarmens yderside.
English: Remove a sachet from the box and tear it open using the slit provided.
Danish: Tag et brev ud af æsken, og riv langs spalten for at åbne det.
English: Things to remember when using the transdermal patch - Do not keep or store the transdermal patch outside the sealed sachet.
Danish: Ting, du skal huske på, mens du bruger depotplastret - Opbevar ikke depotplastret uden for det forseglede brev.
English: SANCUSO is a thin, clear, rectangular-shaped transdermal patch with rounded corners, stuck onto a rigid plastic film.
Danish: SANCUSO er et tyndt, klart, firkantet depotplaster med afrundede kanter, sat på en stiv plasticfilm.. Hver karton indeholder et depotplaster.
English: Population PK modelling has confirmed the absence of a gender effect on the pharmacokinetics of SANCUSO.
Danish: I populationsfarmakokinetiske modeller er det blevet bekræftet, at der ikke forefindes en kønsfordelt virkning på SANCUSO's farmakokinetik.
English: The effects of gender on the pharmacokinetics of SANCUSO have not been specifically studied.
Danish: Farmakokinetiske forhold hos særlige populationer Virkningen af køn på farmakokinetikken af SANCUSO er ikke blevet specifikt undersøgt.
English: - You should avoid external heat (for example hot water bottles or heat pads) on the area of the transdermal patch.
Danish: - Du bør undgå eksterne varmekilder (f.eks. varmedunke eller varmepuder) i området med depotplastret.
English: Take the transdermal patch out of the sachet.
Danish: Tag depotplastret ud af brevet .
English: Each sachet contains one transdermal patch stuck onto a rigid plastic film.
Danish: Hvert brev indeholder et depotplaster, sat på en stiv plasticfilm.
English: External heat, for example from hot water bottles or heat pads, should be avoided on the area of the transdermal patch.
Danish: Eksterne varmekilder, såsom fra varmedunke eller varmepuder, skal undgås i området med depotplastret.
English: - Allergic reactions including urticaria (itchy, red, raised skin rash) and anaphalaxis (a serious allergic reaction which may include sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching) - Difficulty sleeping/disturbed sleep - Excessive sleepiness - Prolonged QT interval in the ECG (changes to the heart rate trace (ECG) indicating a heart rhythm disorder) - Constipation - Diarrhoea - Lack of energy/weakness /Loss of strength
Danish: vejrtrækningsbesvær, hævede øjenlåg, hævet ansigt, hævede læber, udslæt eller kløe) - Søvnbesvær/søvnforstyrrelser - Overdreven søvnighed - Forlænget QT-interval i ekg-målinger (forandringer i hjerterytmen, der kan være et tegn på forstyrrelser af hjerterytmen) - Forstoppelse - Diarré - Mangel på energi/svaghed/tab af styrke
English: Keep the transdermal patch in place for the whole time you are having chemotherapy.
Danish: Sørg for, at depotplastret sidder på plads under hele din kemoterapi.
English: Thin, translucent, matrix-type, rectangular-shaped transdermal patch with rounded corners.
Danish: Tyndt, gennemsigtigt, firkantet depotplaster af matrixtypen med afrundede kanter.
English: Granisetron may be affected by direct natural or artificial sunlight, see section 5.3 for further information.
Danish: Granisetron kan påvirkes af direkte naturligt eller kunstigt sollys se pkt.
English: Metabolism and nutrition disorders Decreased appetite
Danish: Metabolisme og ernæring
English: Due to a gradual increase in plasma levels of granisetron following application of the transdermal patch, a slower onset of efficacy compared to 2 mg oral granisetron may be observed at the start of chemotherapy; the patch should be applied 24-48 hours before chemotherapy.
Danish: Da der er en gradvis forhøjelse af plasmaniveauerne af granisetron efter applikation af depotplastret, kan der observeres en langsommere start af virkning sammenlignet med 2 mg oral granisetron, når kemoterapien påbegyndes.
English: - if you are allergic to granisetron or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to any other anti-sickness medicines whose name ends in “setron” e.g. ondansetron.
Danish: - hvis du er allergisk over for anden medicin mod kvalme og opkastning, med navne, der ender på ”setron”, f.eks. ondansetron.
English: Paediatric population No studies have been performed to investigate the pharmacokinetics of SANCUSO in paediatrics.
Danish: Der er ikke udført studier for at undersøge farmakokinetikken af SANCUSO hos den pædiatriske population.
English: The signs may include red, raised itchy bumps
Danish: Tegn kan være små knopper, der er røde, hævede, og som klør.
English: SANCUSO 3.1 mg/24 hours transdermal patch Granisetron
Danish: SANCUSO 3,1 mg/24 timer, depotplaster granisetron
English: Wear the transdermal patch all the time during your chemotherapy.
Danish: Bær depotplastret under hele din kemoterapi.
English: After removing the transdermal patch
Danish: Efter depotplastret fjernes
English: This leaflet was last revised in July 2018
Danish: Denne indlægsseddel blev senest ændret
English: - There is no information on the effect on the transdermal patch of activities such as strenuous exercise or the use of sauna or whirlpools; therefore, you should avoid these activities while wearing this transdermal patch.
Danish: - Der er ingen information om depotplastrets virkning på aktiviteter som hård træning eller anvendelsen af sauna eller jacuzzi.
English: External heat (for example hot water bottles or heat pads) should be avoided on the area of the transdermal patch.
Danish: Eksterne varmekilder Eksterne varmekilder (f.eks. varmedunke eller varmepuder) skal undgås i området med depotplastret.
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller på apoteket, hvis du tager anden medicin eller har gjort det for nylig.. SANCUSO kan påvirke den måde, nogle lægemidler virker på.
English: - Hypersensitivity reactions, e.g. anaphylaxis, urticaria - Insomnia - Headache - Extrapyramidal reactions - Somnolence - Dizziness - QT prolongation - Constipation - Diarrhoea - Elevated hepatic transaminases - Rash - Asthenia
Danish: Klassevirkningerne for granisetron der ses med andre formuleringer (orale og intravenøse), inkluderer følgende: - Overfølsomhedsreaktioner, f.eks. anafylakse, urticaria - Insomni - Hovedpine - Ekstrapyramidale bivirkninger - Somnolens - Svimmelhed - QT-forlængelse - Obstipation - Diarré - Forhøjede levertransaminaser - Udslæt - Asteni
English: How to use SANCUSO
Danish: Sådan skal du bruge SANCUSO
English: SANCUSO 3.1 mg/24 hours transdermal patch
Danish: SANCUSO 3,1 mg/24 timer, depotplaster
English: If the transdermal patch becomes unstuck
Danish: Hvis depotplastret løsnes
English: It is important to do the following: - while you wear the transdermal patch, keep it covered with clothing if you will be in sunlight or near a sunlamp, including tanning beds - keep the skin where this medicine was applied covered for another 10 days after the transdermal patch is taken off to protect from exposure to direct sunlight.
Danish: Det er vigtigt at gøre følgende: - sørg for at dække depotplastret til med tøj, mens du har plastret på, hvis du er i sollys eller tæt på en sollampe, herunder solarier.
English: What SANCUSO is and what it is used for What you need to know before you use SANCUSO How to use SANCUSO
Danish: Det skal du vide, før du begynder at bruge SANCUSO Sådan skal du bruge SANCUSO Bivirkninger
English: Following routine haematological monitoring, the transdermal patch should only be applied to patients whose chemotherapy treatment is unlikely to be delayed in order to reduce the possibility of unnecessary exposure to granisetron.
Danish: For at reducere risikoen for en unødvendig eksponering over for granisetron, bør evt. nødvendige parakliniske undersøgelser før kemoterapi foreligge, før behandlingen med depotplasteret indledes.
English: When to apply and remove the transdermal patch
Danish: Hvornår skal du sætte depotplastret på og fjerne det?
English: Common Dry mouth, nausea, retching Uncommon
Danish: Mundtørhed, kvalme, opkastningsfornemmelser
English: Hepatic impairment
Danish: Generaliseret ødem
English: Where to apply the transdermal patch
Danish: Hvor skal du sætte depotplastret på?
English: Apply a transdermal patch at least 1 day (24 hours) before you are scheduled to have chemotherapy treatment.
Danish: Tag ikke depotplastret ud af brevet, før du er klar til at bruge det. Sæt depotplastret på mindst 1 dag (24 timer) før din planlagte behandling med kemoterapi.
English: Musculoskeletal and connective tissue disorders
Danish: Knogler, led, muskler og bindevæv Artralgi
English: The transdermal patch may be applied up to a maximum of 2 days (48 hours) before chemotherapy.
Danish: 2 dage (48 timer) før kemoterapi.
English: Gastrointestinal disorders
Danish: depotplaster granisetron
English: If you use more SANCUSO than you should
Danish: Hvis du har brugt for meget SANCUSO
English: • improve your physical function.
Danish: • forbedre din fysiske funktionsevne.
English: Adults (≥18 years)
Danish: Voksne (≥ 18 år)
English: Every 6 to 8 weeks depending on your disease
Danish: Hver 6.-8. uge, afhængigt af din sygdom
English: Radiographic changes were assessed in IMPACT 2.
Danish: Radiografiske ændringer blev vurderet i IMPACT 2.
English: Date of first authorisation: 10 September 2013 Date of latest renewal: 21 June 2018
Danish: Dato for første markedsføringstilladelse: 10. september 2013 Dato for seneste fornyelse: 21. juni 2018
English: Nearly 50% of reported deaths have been associated with infection.
Danish: Næsten 50% af rapporterede dødsfald var forbundet med infektion.
English: EXP EXP, if not refrigerated _________________________
Danish: EXP EXP, hvis ikke opbevaret i køleskab ___________________
English: Because the elimination of infliximab may take up to six months, monitoring should be continued throughout this period.
Danish: Da eliminationen af infliximab kan tage op til seks måneder, bør monitorering fortsættes i denne periode.
English: Approximately 50% of patients were in functional Class III.
Danish: Omkring 50% af patienterne var i funktionsklasse III.
English: • Orencia (which contains abatacept).
Danish: • Orencia (som indeholder abatacept).
English: The reconstituted solution should stand for 5 minutes.
Danish: Den rekonstituerede opløsning skal stå i 5 minutter.
English: • reduce the signs and symptoms of your disease,
Danish: • reducere tegn og symptomer på din sygdom
English: • Kineret (which contains anakinra).
Danish: • Kineret (som indeholder anakinra).
English: (furunculosis)
Danish: (furunkulose)
English: • you are allergic to proteins that come from mice,
Danish: • du er allergisk over for proteiner, som stammer fra mus,
English: This will depend on your disease, weight and how well you respond to Inflectra.
Danish: Dette vil afhænge af din sygdom, vægt, og hvor godt du reagerer på Inflectra.
English: Efficacy has been demonstrated with or without concomitant use of methotrexate.
Danish: Virkningen har været demonstreret med eller uden samtidig brug af methotrexat.
English: • You will be monitored while you are given Inflectra and also for 1 to 2 hours afterwards.
Danish: • Du vil blive overvåget, mens du får Inflectra og i 1-2 timer derefter.
English: Re-administration across indications
Danish: Fornyet administration på tværs af indikationer
English: In ASPIRE, more than 90% of patients had at least two evaluable X-rays.
Danish: I ASPIRE havde mere end 90% af patienterne mindst to bedømmelsesværdige røntgenbilleder.
English: Children and adolescents The information above also applies to children and adolescents.
Danish: Ovenstående oplysninger gælder også for børn og unge.
English: Alternatively, administration of 3 mg/kg as often as every 4 weeks may be considered.
Danish: Alternativt kan administration af 3 mg/kg så ofte som hver 4. uge overvejes.
English: b Absence of any draining fistulas.
Danish: b Fravær af alle drænede fistler.
English: • Blood test result showing ‘antibodies' against your own body.
Danish: • Blodprøveresultater, der viser ”antistoffer” mod din egen krop
English: In this situation, infliximab should be re-initiated as a single dose followed by the maintenance dose recommendations described above.
Danish: I denne situation bør infliximab initieres igen som en enkelt dosis efterfulgt af vedligeholdelsesdoser som anbefalet ovenfor.
English: The majority of serious infusion reactions occurred during the second infusion at week 2.
Danish: De fleste alvorlige infusionsrelaterede reaktioner opstod i forbindelse med den 2. infusion i uge 2.
English: Prolonged or vigorous agitation must be avoided.
Danish: For længe eller for kraftig svingning skal undgås.
English: Instructions for use and handling - storage conditions
Danish: Instruktioner i anvendelse og håndtering - opbevaring
English: • or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.
Danish: • eller alene hos patienter, der udviser intolerance over for methotrexat, eller for hvem methotrexat er kontraindiceret.
English: Key efficacy results for IMPACT and IMPACT 2 are shown in Table 9 below:
Danish: De vigtigste resultater for virkning i IMPACT og IMPACT 2 er vist i tabel 9 nedenfor:
English: Median Improvement from baseline in HAQ averaged over time from week 30 to week 54
Danish: Forbedring fra baseline i HAQ gennemsnitligt over tid fra uge 30 til uge 54