natgillin/translations-raw huggingface dataset:
BILAG II A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERINGOG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Inden for systemorganklassen er bivirkninger opstillet ifølge hyppighed ved hjælp af den følgende konvention: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Within the system organ class, the adverse reactions are listed by frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
I tilfælde af overdosering skal depotplastret fjernes.
In the event of overdose, the transdermal patch should be removed.
Andre bivirkninger associeret med granisetron-produkter (hyppighed ikke kendt):
Other possible side effects associated with granisetron products (frequency not known):
Den gennemsnitlige halveringstid i plasma hos raske personer er 4-6 timer, og hos patienter er den 9-12 timer.
The mean plasma half-life in healthy subjects is 4-6 hours and in patients is 9-12 hours.
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.
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.
Forsøg at undgå at have depotplastret på i vand i lange perioder.
Try to avoid wearing the transdermal patch in water for long periods of time.
- Kontakt med vand ved karbadning eller brusebadning vil ikke ændre den måde, SANCUSO virker på.
- Contact with water during bathing or showering will not change the way SANCUSO works.
Bivirkninger rapporteret for SANCUSO Systemorganklasse
Adverse reactions reported for SANCUSO System Organ Class
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.
Do not use this medicine if you are pregnant unless your doctor has specifically recommended it. Stop breast-feeding while wearing the patch.
Bivirkningerne er opstillet efter faldende sværhedsgrad inden for hver gruppering af hyppighed.
Adverse reactions are presented in order of decreasing seriousness within each frequency grouping.
Efter intravenøs injektion udskilles ca. 12 % af dosis uændret i urinen hos raske personer i løbet af 48 timer.
After intravenous injection, approximately 12% of the dose is excreted unchanged in the urine of healthy subjects in 48 hours.
Du skal kontakte lægen, hvis du ikke har det bedre, eller hvis du har det værre efter den første dags kemoterapi.
You must talk to a doctor if you do not feel better or if you feel worse after the first day of chemotherapy.
Hudreaktioner på applikationsstedet, såsom irritation, kløe eller rødme, er ikke almindelige og kan forekomme hos op til 1 ud af 100 personer.
Skin reactions at the site of application, such as irritation, itching or redness are uncommon and may affect up to 1 in 100 people.
Det nyapplicerede depotplaster skal fjernes i henhold til de tidsmæssige anbefalinger ovenfor.
The newly applied transdermal patch should be removed in line with the timing recommended above.
Den mest almindeligt rapporterede bivirkning i kliniske studier var forstoppelse, der forekom hos ca. 8,7 % af patienterne.
The most commonly reported adverse reaction in clinical studies was constipation, occurring in approximately 8.7% of patients.
Karcinogenicitetsstudier viser ingen speciel risiko for mennesker, når det bruges med den anbefalede dosis.
Carcinogenicity studies showed no special hazard for humans when used at the recommended dose.
- Phenobarbital, anvendes til at behandle epilepsi.
- Phenobarbital, used to treat epilepsy.
Depotplastret må ikke placeres på hud, der er rød, irriteret eller beskadiget.
The transdermal patch should not be placed on skin that is red, irritated or damaged.
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.
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.
Den anbefalede dosis er et enkelt depotplaster.
The recommended dose is one single transdermal patch.
Den kendte farmakokinetiske profil for depotplastret i løbet af den periode, det bæres (7 dage), blev ikke påvirket.
The known pharmacokinetic profile of the transdermal patch over the period of wear (7 days) was not affected.
78 % af patienterne var kaukasiske med 12 % asiater og 10 % af latinsk oprindelse.
78% of patients were white, with 12% Asian and 10% Hispanic/Latino.
Der er ingen data fra anvendelse af granisetron til gravide kvinder.
There are no data on the use of granisetron in pregnant women.
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
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.
Denne variabilitet er sammenlignelig med den kendte store variabilitet i farmakokinetikken af granisetron efter oral eller intravenøs administration.
This variability is similar to the known high variability in granisetron pharmacokinetics after oral or intravenous administration.
Tryk godt ned for at sikre en god kontakt med huden, især langs kanterne.
Press firmly making sure there is good contact with the skin, especially around the edges.
Dette lægemiddel leverer det aktive stof langsomt og konstant via huden og ind i blodbanen i den periode, du bærer depotplastret.
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.
Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, reproduktionstoksicitet og genotoksicitet.
Preclinical data did not reveal any special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, reproductive toxicity and genotoxicity.
Andre lægemidler kan også påvirke den måde, SANCUSO virker på.
Also some other medicines can affect the way SANCUSO works.
Forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjet gammaglutamyltransferase
Alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased
Der findes ingen specifik antidot mod granisetron.
There is no specific antidote for granisetron.
Fortsat med at holde applikationsstedet tildækket i yderligere 10 dage efter, at du fjerner depotplastret.
Continue to keep the application site covered for a further 10 days after removing the transdermal patch.
Granisetron distribueres med et gennemsnitligt fordelingsvolumen på ca. 3 l/kg.
Granisetron is distributed with a mean volume of distribution of approximately 3 l/kg.
Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP Hoofddorp, Holland
Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP Hoofddorp, The Netherlands
Det brugte depotplaster vil stadig indeholde noget granisetron og skal straks bortskaffes som beskrevet i pkt.
The used transdermal patch will still contain some granisetron and should be disposed of immediately as described in section 5.
Der er ingen data for virkningen af granisetron på human fertilitet.
There are no data on the effect of granisetron on human fertility.
Bivirkninger uden kendt hyppighed (kan ikke estimeres ud fra forhåndenværende data) - Overfølsomhedsreaktioner i huden.
Side effects with a frequency not known (cannot be estimated from available data): - allergic skin reactions.
Retningslinjer fra Multinational Association of Supportive Care in Cancer (MASCC) anbefaler administration af dexamethason sammen med 5HT3-antagonist før kemoterapi.
The Multinational Association of Supportive Care in Cancer (MASCC) guidelines recommend the administration of dexamethasone with 5HT3 antagonist prior to chemotherapy.
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.
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.
Depotplastret må ikke anvendes igen efter, at det fjernes, se nedenfor for instruktioner om fjernelse og bortskaffelse af depotplastret (se pkt.
Do not re-use the transdermal patch after removal, see below for instructions on transdermal patch removal and disposal (see section 5).
Granisetron metaboliseres hovedsageligt til 7-hydroxygranisetron og 9'N-desmethylgranisetron.
Granisetron is mainly metabolised to 7-hydroxygranisetron and 9'N-desmethylgranisetron.
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.
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.
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.
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.
Det anbefales derfor at observere patienter for serotoninsyndromlignende symptomer.
Appropriate observation of patients for serotonin syndrome-like symptoms is advised.
Studiet var designet til at vise SANCUSO's non-inferioritet i forhold til oral granisetron.
The study was designed to show non-inferiority of SANCUSO to oral granisetron.
Hvis depotplastret tabes eller beskadiges, skal du tage til lægen.
If the transdermal patch is lost or becomes damaged go back to your doctor.
Der blev ikke observeret nogen forskelle i de metaboliske profiler af granisetron mellem oral og transdermal anvendelse.
No differences in the metabolic profiles of granisetron were observed between the oral and transdermal uses.
Efter applikation af SANCUSO absorberes granisetron langsomt, og maksimale koncentrationer opnås efter 24-48 timer.
Following SANCUSO application, granisetron is absorbed slowly, with maximal concentrations reached between 24 and 48 hours.
Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer) er: - unormale muskelbevægelser (såsom rysten, muskelstivhed og muskelsammentrækninger).
Rare side effects (may affect up to 1 in 1,000 people) are: - abnormal muscle movements (such as shaking, muscle rigidity and muscle contractions).
Anvendte depotplastre indeholder stadig aktivt stof, som kan være skadeligt for andre.
Used transdermal patches still contain active ingredients, which may be harmful to others.
Hvert depotplaster er pakket i et varmeforseglet brev bestående af polyester-overtrukket papir/aluminium/LLDPE.
Each transdermal patch is packaged in a heat-sealed sachet composed of polyester-coated paper/aluminium/LLDPE.
Depotplastrene vil stadig indeholde det aktive stof efter brug.
The transdermal patch will still contain active substance following use.
Granisetron krydser intakt hud og kommer ind i det systemiske kredsløb via en passiv diffusionsproces.
Granisetron crosses intact skin into the systemic circulation by a passive diffusion process.
Hvis du har brugt for meget SANCUSO, skal du blot fjerne det ekstra plaster/de ekstra plastre og kontakte lægen.
If you use more SANCUSO than you should, simply remove the extra patch(es) and contact your doctor.
Som et resultat heraf er SANCUSO indiceret til brug hos patienter, hvor oral antiemetisk administration kompliceres af faktorer, der gør det svært at synke.
Consequently, SANCUSO is indicated for use in patients where oral anti-emetic administration is complicated by factors making swallowing difficult.
Studier med radioligand-binding har vist, at granisetron har en ubetydelig affinitet for andre receptortyper, herunder 5HT1-, 5HT2-, 5HT4- og dopamin D2-bindingssteder.
Radioligand binding studies have demonstrated that granisetron has negligible affinity for other receptor types, including 5HT1, 5HT2, 5HT4 and dopamine D2 binding sites.
Der blev ikke observeret nogen signifikant virkning på QTc-forlængelse for SANCUSO.
No significant effect on QTc prolongation was observed for SANCUSO.
Oral granisetron blev administreret dagligt under hele kemoterapi-programmet, én time før hver dosis kemoterapi.
Oral granisetron was administered daily for the duration of the chemotherapy regimen, one hour prior to each dose of chemotherapy.
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.
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.
Du skal især fortælle til lægen eller sundhedspersonalet, hvis du tager nogle af de følgende lægemidler: - Paracetamol, anvendes til smertebehandling.
In particular, tell your doctor or nurse if you are taking the following medicines: - Paracetamol, used to treat pain.
Granisetron er et kraftigt antiemetikum og en meget selektiv antagonist mod 5-hydroxytryptamin (5HT3-receptorer).
Granisetron is a potent anti-emetic and highly selective antagonist of 5-hydroxytryptamine (5HT3 receptors).
Fertiliteten blev ikke påvirket efter behandling med granisetron hos rotter.
Fertility was unaffected following granisetron treatment in rats.
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.
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.
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.
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.
Du kan fortsat tage brusebade og vaske dig normalt, når du benytter depotplastret.
You can continue to shower and wash normally while wearing the transdermal patch.
Kontakt din læge, hvis du ønsker at fjerne plastret, før kemoterapiforløbet er slut (op til 7 dage).
Talk to your doctor if you want to remove the patch before the end of your chemotherapy treatment course (up to 7 days).
I kliniske studier med SANCUSO blev der rapporteret reaktioner på applikationsstedet, som generelt var lette i intensitet og ikke førte til seponering.
In clinical trials with SANCUSO, application site reactions were reported which were generally mild in intensity and did not lead to discontinuation of use.
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.
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.
Det område, du vælger, må ikke være fedtet, barberet for nyligt eller have hudproblemer som skader (rifter eller afskrabning) eller irritation (rødme eller udslæt).
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).
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.
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.
Vurdering af serie-EKG'er hos patienter viste ingen QT-forlængelse og ingen ændring i EKG-morfologi.
Assessment of serial ECGs in patients showed no QT prolongation and no change in ECG morphology.
Hvis dine arme ikke er hensigtsmæssige områder for depotplastret, kan lægen bede dig om at sætte det på maven.
If your arms are not suitable areas to apply the transdermal patch your doctor may ask you to put it on your abdomen.
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.
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.
I kliniske studier, der blev udført med SANCUSO, blev det vist, at clearance hos cancerpatienter var ca. halvdelen af clearance hos raske personer.
In clinical studies conducted with SANCUSO, clearance in cancer patients was shown to be approximately half that of healthy subjects.
Vask hænder efter placering af depotplastret.
Wash your hands after applying the transdermal patch.
Granisetron var ikke fototoksisk, når det testes in vitro i fibroblast cellelinjen hos mus.
Granisetron was not phototoxic when tested in vitro in a mouse fibroblast cell line.
Hvis det ikke er muligt at applicere depotplastret på armen, kan det appliceres på abdomen.
If it is not possible to apply the transdermal patch to the arm, it can be applied to the abdomen.
Matrixlag Akrylat-vinylacetat-copolymer
Matrix layer Acrylate-vinylacetate copolymer
Hos mennesker har hepatisk enzyminduktion af phenobarbital ført til en forhøjelse i total plasmaclearance (ca. 25 %) efter intravenøs administration af granisetron.
In human subjects, hepatic enzyme induction by phenobarbital has led to an increase in total plasma clearance (approximately 25%) following intravenous administration of granisetron.
Du kan evt. se en let rødme på huden, hvor depotplastret blev fjernet.
You may see mild redness on the skin where the transdermal patch is removed.
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.
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.
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.
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.
Hvis depotplastret løsnes helt eller delvist, skal det oprindelige depotplaster appliceres igen på samme sted med medicinsk tape (hvis det er nødvendigt).
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).
Under tests for potentialet for hudsensibilisering hos marsvin viste SANCUSO et lavt potentiale for irritation.
When tested for skin sensitising potential in guinea pigs, SANCUSO showed a low potential for irritancy.
Granisetron har vist sig at blokere både natrium- og kaliumkanalerne, som kunne påvirke hjertets depolarisering og repolarisering og dermed PR-, QRS- og QT-intervallerne.
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.
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.
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.
Øvrige indholdsstoffer: Akrylat-vinylacetat-copolymer, polyester, silikoniseret polyester.
Other ingredients: acrylate-vinylacetate copolymer, polyester, siliconised polyester.
Hvis dette ikke er muligt, skal et nyt depotplaster appliceres på den anden arm.
If this is not possible, a new transdermal patch should be applied on the opposite arm.
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).
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).
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.
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.
- Ketoconazol, anvendes til at behandle svampeinfektioner.
- Ketoconazole, used to treat fungal infections.
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.
In the pivotal SANCUSO study, the concomitant use of corticosteroids, e.g. dexamethasone, was permitted provided it was part of the chemotherapy regimen.
Vær forsigtig, så depotplastret ikke klæber sammen, og undgå at berøre den klæbende side af depotplastret.
Be careful not to stick the transdermal patch to itself and avoid touching the sticky side of the transdermal patch.
Et studie af klonede humane ionkanaler fra hjertet har vist, at granisetron har potentialet til at påvirke hjertets repolarisation via blokade af hERG kaliumkanaler.
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.