natgillin/translations-raw huggingface dataset:
På baggrund af gennemgang af den tilgængelige information var CHMP af den opfattelse, at dette lægemiddels kvalitet, sikkerhed og virkning fortsat er hensigtsmæssigt og tilstrækkeligt dokumenteret, og balancen mellem fordel og risiko for Sustiva ansås derfor som værende positiv.
Based on the review of the available information, the CHMP was of the opinion that the quality, the safety and the efficacy of this medicinal product continues to be adequately and sufficiently demonstrated and therefore considered that the benefit/risk balance of Sustiva remains favourable.
Sutent er et lægemiddel, som indeholder det aktive stof sunitinib.
Sutent is a medicine containing the active substance sunitinib.
Det fås som kapsler (orange:
It is available as capsules (orange:
12, 5 mg; karamelfarvede og orange:
12.5 mg; caramel and orange:
25 mg; karamelfarvede 50 mg).
50 mg).
Sutent anvendes til behandling af patienter med en af følgende kræftformer: • gastrointestinal stromal tumor (GIST), en form for kræft (et sarkom) i maven og tarmene, hvor der er en ukontrolleret vækst af celler i det omkringliggende væv i disse organer.
Sutent is used to treat patients with one of the following types of cancer: • gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel, where there is uncontrolled growth of cells in the supporting tissues of these organs.
Sutent anvendes ved GIST hos patienter med svulster, der ikke kan fjernes ved operation eller som har bredt sig til andre organer, når behandling med imatinib (et andet middel mod kræft) er slået fejl eller ikke tåles af patienten. • renalcellecarcinom (RCC), en form for nyrekræft.
Sutent is used in GIST patients with tumours that cannot be removed with surgery, or that have spread to other organs, when treatment with imatinib (another anticancer medicine) has failed or cannot be tolerated by the patient; • renal cell carcinoma (RCC), a type of kidney cancer.
Sutent anvendes til behandling af kræft, der er på et fremskredent stadium eller som har bredt sig til andre organer.
Sutent is used when the cancer is at an advanced stage, or has spread to other organs.
Behandling med Sutent bør kun indledes af læger med erfaring i behandling af GIST eller RCC.
Treatment with Sutent should only be initiated by doctors who have experience in the treatment of GIST or RCC.
Sutent gives i seksugers perioder med 50 mg dagligt i fire uger efterfulgt af to uger uden behandling.
Sutent is given in six-week cycles, with 50 mg a day for four weeks, followed by two weeks off treatment.
Den anbefalede dosis er 50 mg, men kan justeres op eller ned, afhængigt af patientens reaktion på behandlingen, dog ikke under 25 mg eller over 75 mg.
Although the recommended dose is 50 mg, this can be adjusted to a higher or lower dose according to the patient’ s response to the treatment, provided that the dose does not go below 25 mg or above 75 mg.
Sunitinib, det aktive stof i Sutent, er en proteinkinasehæmmer.
The active substance in Sutent, sunitinib, is a protein kinase inhibitor.
Det vil sige, at det blokerer nogle bestemte enzymer, der kaldes proteinkinaser.
This means that it blocks some specific enzymes known as protein kinases.
Disse enzymer findes i visse receptorer på kræftcellernes overflade, som f. eks.
By blocking these enzymes, Sutent can reduce the growth and spread of the cancer.
"KIT" - receptorerne på overfladen af GIST- celler og lignende receptorer på overfladen af RCC- celler, hvor de medvirker til kræftcellernes vækst og spredning.
The effects of Sutent were first tested in experimental models before being studied in humans.
Ved at blokere disse enzymer kan Sutent mindske kræftcellernes vækst og spredning
The effectiveness of Sutent in GIST was studied in 312 patients who could not receive imatinib, or for whom treatment with imatinib had failed.
Reproduction is authorised provided the source is acknowledged Hvordan blev Sutent undersøgt?
Reproduction is authorised provided the source is acknowledged.
Sutent blev sammenlignet med placebo (virkningsløs behandling).
The study was double blinded (neither the doctor nor the patient knew which treatment the patient was receiving), and it measured the time taken for the disease to get worse.
Med hensyn til RCC blev Sutent undersøgt hos 750 patienter, hvis cancer ikke tidligere var blevet behandlet.
In RCC, Sutent was studied in 750 patients whose cancer had not been treated before.
I undersøgelsen blev virkningen af Sutent sammenlignet med interferon alfa (standard - førstegangsbehandling for denne form for kræft).
The study compared the effects of Sutent and interferon alfa (the standard first-line treatment for this type of cancer).
Virkningen blev hovedsagelig bedømt på ” progressionsfri overlevelse ” (den tid der gik, før kræften blev værre, eller patienten døde).
The main measure of effectiveness was ‘ progression-free survival ’ (the length of time until the cancer got worse or the patient died).
Den tid, der gik, til sygdommen blev værre, var 27, 3 uger hos patienter, der fik Sutent, og 6, 4 uger hos patienter, der fik placebo.
Sutent was more effective than placebo in GIST: it took 27.3 weeks for the disease to get worse in patients who received Sutent and 6.4 weeks in patients who received placebo.
Interimresultaterne (dvs. de resultater, der gøres op, inden undersøgelsen er slut) var så gode, at undersøgelsen på et tidligt tidspunkt blev standset.
The interim results (results calculated before the study was finished) were sufficiently good for the study to be stopped early and for the patients who were receiving placebo to be switched to Sutent.
De patienter, der havde fået placebo, skiftede derefter til Sutent.
In RCC, progression-free survival was longer in the patients taking Sutent.
Ved renalcellecarcinom var den progressionsfrie overlevelse længere for de patienter, som fik Sutent.
It took 47.3 weeks for the disease to get worse or the patient to die in the Sutent group, compared with 22.0 weeks in the group taking interferon alfa.
I de kliniske undersøgelser var de hyppigste bivirkninger ved Sutent (som ses hos flere end 1 ud af 10 patienter) anæmi (lavt antal røde blodlegemer), neutropeni (lavt antal hvide blodlegemer), rombocytopeni (lavt antal blodplader), hypothytoidisme (nedsat aktivitet af skjoldbruskkirtelen), nedsat appetit, smagsforstyrrelser, hovedpine, for højt blodtryk, epistaksis (næseblod) diarré, kvalme, opkastning, stomatitis (betændelse i mundslimhinden), dyspepsi (halsbrand), mavesmerter, udspilet mave, forstoppelse, glossodyni (brændende eller prikkende fornemmelse i eller omkring munden), flatulens (luft i maven), smerter i munden, tørhed i munden, gulfarvning eller misfarvning af huden, palmar- plantar erytrodysæstesi (hævelse og følelsesløshed på håndflader og fodsåler), ændring af hårfarve, udslæt, tør hud, hårtab, smerter i ekstremiteterne (hænder og fødder) eller arme og ben, træthed, kraftesløshed, betændelse i slimhinder, ødem (hævelse), nedsat uddrivningsfraktion (mindskning af den blodmængde, der pumpes ud af hjertet ved hvert hjerteslag) og vægttab.
In clinical studies, the most common side effects with Sutent (seen in more than 1 patient in 10) were anaemia (low red blood cell counts), neutropenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), hypothyroidism (underactive thyroid gland), decreased appetite, taste disturbance, headache, hypertension (high blood pressure), epistaxis (nosebleeds), diarrhoea, nausea (feeling sick), vomiting, stomatitis (inflammation of the lining of the mouth), dyspepsia (heartburn), abdominal (tummy) pain or distension (bloating), constipation, glossodynia (burning or tingling sensation around the mouth), flatulence (gas), oral (mouth) pain, dry mouth, yellow skin or skin discoloration, palmar-plantar erythrodysaesthesia syndrome (swelling and numbness of the palms and soles of the feet), hair colour changes, rash, dry skin, alopecia (hair loss), pain in the extremities (hands and feet) or limbs, fatigue or asthenia (tiredness or weakness), mucosal inflammation (inflammation of the moist body surfaces), oedema (swelling) decreased ejection fraction (reduced amount of blood pumped out in each heartbeat) and decreased weight.
Den fuldstændige liste over de indberettede bivirkninger ved Sutent fremgår af indlægssedlen.
For the full list of all side effects reported with Sutent, see the Package Leaflet.
Sutent bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for sunitinib eller nogen af indholdsstofferne.
Sutent should not be used in people who may be hypersensitive (allergic) to sunitinib or any of the other ingredients.
Der skal udvises forsigtighed ved samtidig indgivelse af visse andre lægemidler såsom rifampicin (et middel mod tuberkulose) og ketoconazol (et svampemiddel).
Caution should be taken when it is given with some medicines, such as rifampicin (used in tuberculosis) or ketoconazole (an antifungal medicine).
Den fuldstændige liste over de lægemidler, der kan vekselvirke med Sutent, fremgår af indlægssedlen.
See the Package Leaflet for the list of the medicines that may interact with Sutent.
Udvalget for Humanmedicinske Lægemidler (CHMP) besluttede, at fordelene ved Sutent opvejer risiciene ved behandling af inoperabelt og/ eller malignt GIST, hvor forudgående behandling med imatinib mesilat ikke virker eller ikke tåles, og til behandling af fremskreden og/ eller metastaserende RCC.
The Committee for Medicinal Products for Human Use (CHMP) decided that Sutent’ s benefits are greater than its risks for the treatment of unresectable and/ or metastatic malignant GIST after failure of imatinib mesilate treatment due to resistance or intolerance, and for the treatment of advanced and/ or metastatic RCC.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Sutent.
The Committee recommended that Sutent be given marketing authorisation.
Der blev oprindeligt udstedt en ” betinget godkendelse ” for Sutent.
Sutent was originally given ‘ Conditional Approval’.
Det betyder, at der ville komme flere oplysninger om lægemidlet, navnlig vedrørende behandling af renalcellecarcinom.
This means that there was more evidence to come about the medicine, in particular in the treatment of renal cell carcinoma.
Da firmaet havde fremlagt de fornødne supplerende oplysninger, blev tilladelsen ændret fra en ” betinget ” til en ” normal ” markedsføringstilladelse den 11. januar 2007.
As the company had supplied the additional information necessary, the authorisation was switched from ‘ conditional ’ to ‘ normal’ approval on 11 January 2007.
Andre oplysninger om Sutent:
Other information about Sutent:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Sutent til Pfizer Ltd den 19. juli 2006.
The European Commission granted a marketing authorisation valid throughout the European Union for Sutent to Pfizer Ltd on 19 July 2006.
Den fuldstændige EPAR for Sutent findes her.
The full EPAR for Sutent can be found here.
EU- nummer EU/ 1/ 06/ 347/ 001 EU/ 1/ 06/ 347/ 002 EU/ 1/ 06/ 347/ 003 EU/ 1/ 06/ 347/ 004 EU/ 1/ 06/ 347/ 005 EU/ 1/ 06/ 347/ 006
EU Number EU/ 1/ 06/ 347/ 001 EU/ 1/ 06/ 347/ 002 EU/ 1/ 06/ 347/ 003 EU/ 1/ 06/ 347/ 004 EU/ 1/ 06/ 347/ 005 EU/ 1/ 06/ 347/ 006
Særnavn SUTENT SUTENT SUTENT SUTENT SUTENT SUTENT
Invented name Sutent Sutent Sutent Sutent Sutent Sutent
Styrke 12, 5 mg 25 mg 50 mg 12, 5 mg 25 mg 50 mg
Strength 12.5 mg 25 mg 50 mg 12.5 mg 25 mg 50 mg
Lægemiddelform Kapsler, hårde Kapsler, hårde Kapsler, hårde Kapsler, hårde Kapsler, hårde Kapsler, hårde
Pharmaceutical Form Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard
Indgivelsesvej Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
Route of Administration Oral use Oral use Oral use Oral use Oral use Oral use
Emballage beholder (HDPE) beholder (HDPE) beholder (HDPE) Blister (Aclar/ PVC) Blister (Aclar/ PVC) Blister (Aclar/ PVC)
Packaging bottle (HDPE) bottle (HDPE) bottle (HDPE) blister (Aclar/ PVC) blister (Aclar/ PVC) blister (Aclar/ PVC)
Paknings- størrelse 30 kapsler 30 kapsler 30 kapsler 28 kapsler 28 kapsler 28 kapsler
Package size 30 capsules 30 capsules 30 capsules 28 capsules 28 capsules 28 capsules
Sutent 12, 5 mg hårde kapsler
SUTENT 12.5 mg hard capsules
Hver kapsel indeholder sunitinibmalat svarende til 12, 5 mg sunitinib.
Each capsule contains sunitinib malate, equivalent to 12.5 mg of sunitinib.
6. 1.
80.0 mg of mannitol For a full list of excipients, see section 6.1.
Hårde kapsler Gelatinekapsler med orange overdel og orange underdel, der med hvidt blæk er mærket ” Pfizer ” på overdelen, ” STN 12, 5 mg ” på underdelen, og som indeholder gule til orange granulater.
Gelatin capsules with orange cap and orange body, printed with white ink “ Pfizer” on the cap, “ STN 12.5 mg” on the body, and containing yellow to orange granules.
Gastrointestinal stromal tumor (GIST) SUTENT er indiceret til behandling af inoperabel og/ eller metastaserende malign gastrointestinal stromal tumor (GIST) efter behandlingssvigt med imatinibmesilat på grund af resistens eller intolerans.
Gastrointestinal Stromal Tumour (GIST) SUTENT is indicated for the treatment of unresectable and/ or metastatic malignant gastrointestinal stromal tumour (GIST) after failure of imatinib mesylate treatment due to resistance or intolerance.
Metastaserende renalcellecarcinom (mRCC) SUTENT er indiceret til behandling af avanceret og/ eller metastaserende renalcellecarcinom (mRCC).
Metastatic Renal Cell Carcinoma (MRCC) SUTENT is indicated for the treatment of advanced and/ or metastatic renal cell carcinoma (MRCC).
Behandlingen bør initieres af en læge med erfaring i behandling af renalcellecarcinom eller GIST.
Therapy should be initiated by a physician experienced in the treatment of renal cell carcinoma or GIST.
Dette udgør en hel behandlingscycklus på 6 uger.
The recommended dose of SUTENT is one 50 mg dose orally, taken daily for 4 consecutive weeks, followed by a 2-week rest period (schedule 4/ 2) to comprise a complete cycle of 6 weeks.
Dosisjustering Sikkerhed og tolerans På baggrund af individuel sikkerhed og tolerans kan dosisjusteringer med en dosistilvækst på 12, 5 mg ad gangen anvendes.
Dose adjustments Safety and Tolerability Dose modifications in 12.5-mg steps may be applied based on individual safety and tolerability.
Den daglige dosis må hverken overskride 75 mg eller blive nedsat til under 25 mg.
Daily dose should not exceed 75 mg nor be decreased below 25 mg.
4. 4 og 4. 5).
CYP3A4 Inhibitors/ Inducers Co-administration of potent CYP3A4 inducers such as rifampin, should be avoided (see sections 4.4 and 4.5).
Hvis dette ikke er muligt, kan det være nødvendigt at øge dosis af SUTENT med en dosistilvækst på 12, 5 mg ad gangen (op til 87, 5 mg om dagen) med omhyggelig monitorering af tolerans.
If this is not possible, the dose of SUTENT may need to be increased in 12.5 mg increments (up to 87.5 mg per day) based on careful monitoring of tolerability.
4. 4 og 4. 5).
Co-administration of SUTENT with potent CYP3A4 inhibitors, such as ketoconazole, should be avoided (see sections 4.4 and 4.5).
Hvis dette ikke er muligt, kan det være nødvendigt at nedsætte dosis af SUTENT til minimum 37, 5 mg dagligt med omhyggelig monitorering af tolerans.
If this is not possible the doses of SUTENT may need to be reduced to a minimum of 37.5 mg daily, based on careful monitoring of the tolerability.
Anvendelse af anden samtidig medicin med ingen eller minimal mulighed for at inducere eller hæmme CYP3A4 bør overvejes.
Selection of an alternate concomitant medication with no, or minimal potential to induce or inhibit CYP3A4 should be considered.
2 Børn:
Paediatric use:
Sikkerhed og effekt af SUTENT hos børn er ikke fastlagt.
The safety and efficacy of SUTENT in paediatric patients have not been established.
SUTENT bør ikke anvendes til børn, før yderligere data er tilgængelige.
2 SUTENT should not be used in paediatric population until further data become available.
Ca.
Elderly patients use:
34% af patienterne i de kliniske undersøgelser med SUTENT var 65 år eller derover.
Approximately 34% of the subjects in clinical studies of SUTENT were 65 or over.
Der ses ingen signifikant forskel i sikkerhed eller effekt mellem unge og ældre patienter.
No significant differences in safety or effectiveness were observed between younger and older patients.
Dosisjustering er ikke nødvendig, når SUTENT anvendes til patienter med mildt eller moderat nedsat leverfunktion (Child- Pugh klasse A og B).
No dose adjustment is recommended when administering SUTENT to patients with mild or moderate (Child-Pugh Class A and B) hepatic impairment.
5. 2).
SUTENT has not been studied in subjects with Child-Pugh Class C hepatic impairment (see section 5.2).
Der er ikke udført kliniske undersøgelser hos patienter med nedsat nyrefunktion (se pkt.
No clinical studies have been performed in patients with impaired renal function.
SUTENT kan tages med eller uden mad.
SUTENT may be taken with or without food.
Hvis en dosis glemmes, bør patienten ikke tage en yderligere dosis.
If a dose is missed the patient should not be given an additional dose.
Overfølsomhed over for sunitinibmalat eller over for et eller flere af hjælpestofferne.
Hypersensitivity to sunitinib malate or to any of the excipients.
Samtidig anvendelse af SUTENT og potente CYP3A4- induktorer, som f. eks. rifampin kan nedsætte plasmakoncentrationen af sunitinib.
Co-administration of potent CYP3A4 inducers such as rifampin, may decrease sunitinib plasma concentrations.
Derfor bør kombination med induktorer undgås.
Combination with inducers should therefore be avoided.
4. 2 og 4. 5).
If this is not possible, the dosage of SUTENT may need to be increased (see sections 4.2 and 4.5).
Samtidig anvendelse af SUTENT og potente CYP3A4- hæmmere, som f. eks. ketoconazol, kan øge plasmakoncentrationen af sunitinib.
Co-administration of strong CYP3A4 inhibitor such as ketoconazole may increase sunitinib plasma concentrations.
Det anbefales at anvende anden samtidig medicin med ingen eller minimal enzymhæmning.
Selection of an alternate concomitant medication with no or minimal enzyme inhibition potential is recommended.
4. 2 og 4. 5).
If this is not possible, the dosage of SUTENT may need to be reduced (see sections 4.2 and 4.5).
30% af patienterne.
Skin and tissues Skin discolouration, possibly due to the active substance colour (yellow) is a common treatment-related adverse event occurring in approximately 30% of patients.
Patienter bør informeres om, at depigmentering af hår eller hud også kan forekomme under behandling med SUTENT.
Patients should be advised that depigmentation of the hair or skin may also occur during treatment with SUTENT.
Andre mulige dermatologiske virkninger kan omfatte tørhed og fortykkelse af hud eller revnet hud, blærer eller lejlighedsvis udslæt på håndflader og fodsåler.
Other possible dermatologic effects may include dryness, thickness or cracking of the skin, blisters or occasional rash on the palms of the hands and soles of the feet.
14% af patienterne.
Mouth pain/ irritation was reported in approximately 14% of patients.
28% af patienterne.
Dysgeusia (taste disturbance) was reported in approximately 28% of patients.
Disse hændelser er ikke kumulative, men er typisk reversible og fører sædvanligvis ikke til seponering af behandling.
The above events were not cumulative, were typically reversible and generally did not result in treatment discontinuation.
Disse hændelser omfatter gastrointestinale blødninger, blødninger i luftvejene, tumor -, urinvejs - og hjerneblødninger.
Haemorrhage Haemorrhagic events, some of which were fatal, reported through post-marketing experience, have included GI, respiratory, tumour, urinary tract and brain haemorrhages.
2% af patienterne med GIST.
In clinical trials treatment-related tumour haemorrhage occurred in approximately 2% of patients with GIST.
I tilfælde af pulmonale tumorer kan der være tale om alvorlig og livstruende hæmoptyse eller pulmonal blødning.
These events may occur suddenly, and in the case of pulmonary tumours, may present as severe and life-threatening haemoptysis or pulmonary haemorrhage.
I en klinisk undersøgelse hos patienter med metastaserende ikke- småcellet lungecancer (NSCLC) fik 2 patienter, der fik SUTENT, fatal pulmonalblødning.
Fatal pulmonary haemorrhage occurred in 2 patients receiving SUTENT on a clinical trial of patients with metastatic non-small cell lung cancer (NSCLC).
Begge patienter havde pladecellehistologi.
Both patients had squamous cell histology.
SUTENT er ikke godkendt til behandling af patienter med NSCLC.
SUTENT is not approved for use in patients with NSCLC.
I en fase 3 GIST- undersøgelse forekommer blødningshændelser hos 18% af patienterne, der får SUTENT sammenlignet med 17% af patienterne, der får placebo.
Bleeding events occurred in 18% of patients receiving SUTENT in a phase 3 GIST Study compared to 17% of patients receiving placebo.
Hos de patienter, der får SUTENT for behandlingsnaiv mRCC, får 28% hændelser med blødning sammenlignet med 7% af patienterne, der
In patients receiving SUTENT for treatment-naïve MRCC, 28% had bleeding events compared to 7% of patients receiving IFN-α.
3 får IFN- α.
Seven (1.9%) patients on sunitinib malate versus 0% of patients on IFN-α experienced Grade 3 or greater treatment-related bleeding events.
Hos 7 patienter (1, 9%), der får sunitinibmalat, forekommer behandlingsrelateret blødning i Grad 3 eller højere sammenlignet med 0% af patienterne, der får IFN- α.
Of patients receiving sunitinib malate for cytokine-
26% af patienterne, der får sunitinibmalat til behandling af cytokin- refraktær mRCC, oplever blødning.
3 refractory MRCC, 26% experienced bleeding.
Rutineundersøgelser af denne bivirkning bør omfatte en fuldstændig blodtælling og objektiv undersøgelse.
Routine assessment of this event should include complete blood counts and physical examination.
Epistaxis er den mest almindelig behandlingsrelaterede bivirkning inden for blødning, hvor ca. halvdelen af patienterne med solide tumorer oplever blødning.
Epistaxis was the most common treatment-related haemorrhagic adverse event, having been reported for approximately half of the patients with solid tumours who experienced haemorrhagic events.
Nogle af disse bivirkninger er alvorlige, men meget sjældent fatale.
Some of these events were severe, but very rarely fatal.
Gastrointestinale hændelser Kvalme, diarré, stomatitis, dyspepsi og opkastning er de mest almindeligt rapporterede gastrointestinale bivirkninger relateret til behandling.
Gastrointestinal events Nausea, diarrhoea, stomatitis, dyspepsia and vomiting were the most commonly reported treatment-related gastrointestinal events.
Disse gastrointestinale bivirkninger kan kræve understøttende behandling, som omfatter antiemetika eller obstipantia.
Supportive care for gastrointestinal adverse events requiring treatment may include medication with an anti- emetic or anti-diarrhoeal medication.
Gastrointestinale system Alvorlige, og til tider fatale gastrointestinale komplikationer, herunder gastrointestinal perforation ses sjældent hos patienter med intraabdominal malignitet behandlet med SUTENT.
Gastrointestinal tract Serious, sometimes fatal gastrointestinal complications including gastrointestinal perforation have occurred rarely in patients with intra-abdominal malignancies treated with SUTENT.
I fase 3 GIST - undersøgelsen forekommer behandlingsrelateret fatal gastrointestinal blødning hos 0, 5% af patienterne, der får placebo.
Treatment-related fatal gastrointestinal bleeding occurred in 0.5% of patients receiving placebo in the GIST Phase 3 study.
16% af patienterne med solide tumorer.
Hypertension Treatment-related hypertension was reported in approximately 16% of patients with solid tumours.
2, 7% af patienterne i denne patientpopulation.
SUTENT dosing was reduced or temporarily delayed in approximately 2.7% of this patient population.
Ingen af disse patienter fik seponeret behandlingen med SUTENT.
None of these patients were discontinued from treatment with SUTENT.