natgillin/translations-raw huggingface dataset:
Det aktive stof i TORISEL, temsirolimus, er et kræftmiddel, der virker ved at hæmme proteinet mTOR ("mammalian target of rapamycin").
The active substance in TORISEL, temsirolimus, is an anticancer medicine, which acts by blocking a protein called ‘ mammalian target of rapamycin’ (mTOR).
I kroppen bindes temsirolimus til et protein inde i cellerne, hvorved der dannes et kompleks.
In the body, temsirolimus attaches to a protein that is found inside cells to make a ‘ complex’.
Da mTOR medvirker ved styringen af cellers deling, forhindrer TORISEL kræftcellerne i at dele sig og hæmmer derved vækst og spredning af nyrekræft.
Since mTOR is involved in the control of cell division, TORISEL prevents the division of cancer cells, slowing down the growth and spread of kidney cancer.
Hvordan blev TORISEL undersøgt?
How has TORISEL been studied?
Virkningerne af TORISEL blev først testet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of TORISEL were first tested in experimental models before being studied in humans.
Virkningen af TORISEL blev undersøgt i én hovedundersøgelse med deltagelse af 626 patienter med fremskreden nyrekræft og dårlig prognose.
The effectiveness of TORISEL has been studied in one main study involving 626 patients who had advanced renal cell carcinoma and a poor prognosis.
I undersøgelsen sammenlignedes virkningerne af TORISEL, 25 mg én gang ugentligt, med virkningerne af interferon alfa (et andet middel mod kræft)
The study compared the effects of 25 mg TORISEL given once a week with those of interferon alfa (another anticancer medicine) and with those of the combination of 15 mg TORISEL once a week in combination with interferon alfa.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged og af TORISEL, 15 mg én gang ugentligt i kombination med interferon alfa.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has TORISEL shown during the studies?
De patienter, der kun fik TORISEL, overlevede længere end de, de kun fik interferon alfa.
Patients receiving TORISEL alone survived for longer than those taking interferon alfa alone.
I hovedundersøgelsen overlevede de patienter, der kun fik TORISEL, gennemsnitligt i 10, 9 måneder, sammenholdt med 7, 3 måneder for dem, der kun fik interferon alfa.
In the main study, the patients receiving TORISEL alone survived for an average of 10.9 months, compared with 7.3 months in those receiving interferon alfa alone.
For de patienter, der fik den lave dosis TORISEL i kombination med interferon alfa, var overlevelsen den samme (8, 4 måneder) som for dem, der kun fik interferon alfa.
The patients receiving the lower dose of TORISEL in combination with interferon alfa survived for a similar length of time (8.4 months) to those taking interferon alfa alone.
Hvilken risiko er der forbundet med TORISEL?
What is the risk associated with TORISEL?
De almindeligste bivirkninger af TORISEL (der ses hos flere end 3 ud af 10 patienter), er anæmi (for lavt antal røde blodlegemer), kvalme, udslæt, appetitløshed, væskeansamling og kraftesløshed.
The most common side effects with TORISEL (seen in more than 3 patients in 10) are anaemia (low red blood cell counts), nausea (feeling sick), rash, anorexia (loss of appetite), oedema (swelling) and asthenia (weakness).
Den fuldstændige liste over de indberettede bivirkninger for TORISEL fremgår af indlægssedlen.
For the full list of all side effects reported with TORISEL, see the Package Leaflet.
TORISEL bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for temsirolimus eller dettes nedbrydningsprodukter, herunder sirolimus (et lægemiddel, der anvendes til at undertrykke afstødning af transplanterede nyrer), over for polysorbat 80 eller over for nogen af de andre indholdsstoffer.
TORISEL should not be used in people who may be hypersensitive (allergic) to temsirolimus, to its metabolites (the substances that it is broken down into) including sirolimus (a medicine used to prevent rejection of transplanted kidneys), to polysorbate 80 or to any of the other ingredients of the medicine.
Hvorfor blev TORISEL godkendt?
Why has TORISEL been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) fandt, at fordelene ved TORISEL opvejer risiciene til førstevalgsbehandling af patienter, der har fremskreden nyrekræft og opfylder mindst tre af følgende risikofaktorer for sygdomsforløbet: • diagnosen nyrekræft blev oprindeligt stillet for mindre end ét år siden, • patientens score på Karnofsky- skalaen er under 70, • hæmoglobinindholdet er under den nedre normalværdi, • den korrigeret kalciumværdi er over 10 mg/ dl, • laktatdehydrogenase er over 1, 5 gange den øvre normalværdi, • sygdommen har bredt sig med dattersvulster flere steder.
The Committee for Medicinal Products for Human Use (CHMP) decided that TORISEL’ s benefits are greater than its risks for the first-line treatment of patients with advanced renal cell carcinoma who have at least three of the following prognostic risk factors: • less than one year from time of initial renal cell carcinoma diagnosis, • Karnofsky score status of less than 70, • haemoglobin less than the lower limit of normal, • corrected calcium of greater than 10 mg/ dl, • lactate dehydrogenase over 1.5 times the upper limit of normal, • more than one metastatic organ site.
Udvalget anbefalede udstedelse af markedsføringstilladelse for TORISEL.
The Committee recommended that TORISEL be given marketing authorisation.
Andre oplysninger om TORISEL:
Other information about TORISEL:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for TORISEL til Wyeth Europa Ltd den 19. november 2007.
The European Commission granted a marketing authorisation valid throughout the European Union for TORISEL to Wyeth Europa Ltd on 19 November 2007.
Registreringen af udpegelsen af TORISEL som lægemiddel til sjældne sygdomme kan ses her.
The record of TORISEL’ s designation as an orphan medicine is available here.
Den fuldstændige EPAR for TORISEL findes her
The full EPAR for TORISEL can be found here.
Hætteglas (glas) + hætteglas (glas)
vial (glass) + vial (glass)
TORISEL 25 mg/ ml koncentrat og solvens til infusionsvæske, opløsning.
TORISEL 25 mg/ ml concentrate and diluent for solution for infusion.
Et hætteglas TORISEL 25 mg/ ml koncentrat indeholder:
1 vial TORISEL 25 mg/ ml concentrate contains:
1 ml TORISEL koncentrat indeholder derfor 25 mg temsirolimus.
30 mg temsirolimus dissolved in a total volume of 1.2 ml Therefore, 1 ml of TORISEL concentrate contains 25 mg temsirolimus.
Efter fortynding af TORISEL 25 mg/ ml koncentrat med 1, 8 ml af solvensen er koncentrationen af temsirolimus 10 mg/ ml.
After dilution of TORISEL 25 mg/ ml concentrate with 1.8 ml of withdrawn diluent, the concentration of temsirolimus is 10 mg/ ml.
Et hætteglas TORISEL 25 mg/ ml koncentrat indeholder 474 mg vandfri ethanol.
1 vial TORISEL 25 mg/ ml concentrate contains 474 mg anhydrous ethanol.
Et hætteglas af den medfølgende solvens indeholder 358 mg vandfri ethanol.
1 vial of the diluent, provided contains 358 mg anhydrous ethanol.
Koncentrat og solvens til infusionsvæske, opløsning.
Concentrate and diluent for solution for infusion.
Koncentratet er en klar, farveløs til lysegul opløsning, i alt væsentligt fri for synlige partikler.
The concentrate is a clear, colourless to light-yellow solution, essentially free from visible particulates.
Solvensen er en klar til let uklar, lysegul til gul opløsning, i alt væsentligt fri for synlige partikler.
The diluent is a clear to slightly turbid, light-yellow to yellow solution, essentially free from visible particulates.
5. 1).
TORISEL is indicated for the first-line treatment of patients with advanced renal cell carcinoma who have at least three of six prognostic risk factors (see section 5.1).
TORISEL skal indgives under overvågning af en læge, der har erfaring i brug af antineoplastiske lægemidler.
TORISEL must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
Det totale volumen (1, 2 ml) af et hætteglas TORISEL 25 mg/ ml koncentrat skal fortyndes med 1, 8 ml af solvensen for at opnå en koncentration på 10 mg/ ml temsirolimus.
The total volume (1.2 ml) of 1 vial TORISEL 25 mg/ ml concentrate must be diluted with 1.8 ml of withdrawn diluent to achieve a concentration of temsirolimus of 10 mg/ ml.
Træk den ønskede mængde af temsirolimus- blandingen på 10 mg/ ml op og injicér hurtigt ind i en natriumklorid 9 mg/ ml (0, 9%) opløsning til injektion.
Withdraw the required amount of the temsirolimus 10 mg/ ml mixture and then inject rapidly into sodium chloride 9 mg/ ml (0.9%) solution for injection.
6. 6 vedrørende vejledning om fortynding, indgift og bortskaffelse).
2 The recommended dose of temsirolimus for advanced renal cell carcinoma administered intravenously is 25 mg infused over a 30- to 60-minute period once weekly (see section 6.6 for instructions on dilution, administration and disposal).
30 minutter før starten på hver temsirolimusdosis.
Patients should be given intravenous diphenhydramine 25 to 50 mg (or similar antihistamine) approximately 30 minutes before the start of each dose of temsirolimus.
2 Behandlingen med TORISEL skal fortsætte, indtil patienten ikke længere har klinisk nytte af behandlingen, eller indtil der opstår uacceptabel toksicitet.
Treatment with TORISEL should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.
Der kræves ingen speciel ændring af dosis for de populationer, der er blevet undersøgt (køn, ældre).
No special dose modification is required for any of the populations that have been studied (gender, elderly).
Behandling af formodede bivirkninger kan kræve midlertidig afbrydelse og/ eller dosisreduktion af temsirolimusbehandlingen.
Management of suspected adverse reactions may require temporary interruption and/ or dose reduction of temsirolimus therapy.
Hvis en formodet bivirkning ikke kan kontrolleres ved udsættelse af dosis, kan temsirolimus reduceres med formindskelser på 5 mg/ uge.
If a suspected reaction is not manageable with dose delays, then temsirolimus may be reduced by 5 mg/ week decrements.
Pædiatriske patienter Erfaringerne med pædiatriske patienter er begrænset.
Paediatric patients Experience in paediatric patients is limited.
Sikkerheden og effekten hos pædiatriske patienter er ikke blevet fastlagt.
The safety and effectiveness in paediatric patients have not been established.
TORISEL bør derfor ikke anvendes til den pædiatriske population, før der er yderligere oplysninger tilgængelige om effekten og sikkerheden.
Therefore, the use of TORISEL in the paediatric population is not recommended until further information on effectiveness and safety is available.
Ældre patienter Det er ikke nødvendigt med særlig dosisjustering.
Elderly patients No specific dose adjustment is necessary.
Nyreinsufficiens Der anbefales ikke dosisjustering af temsirolimus hos patienter med nyreinsufficiens.
Renal impairment No dose adjustment of temsirolimus is recommended in patients with renal impairment.
4. 4).
Temsirolimus should be used with caution in patients with severe renal impairment (see section 4.4).
Leverinsufficiens Temsirolimus skal anvendes med forsigtighed til patienter med leverinsufficiens.
Hepatic impairment Temsirolimus should be used with caution in patients with hepatic impairment.
4. 4).
Use of temsirolimus in patients with severe hepatic impairment is not recommended (see section 4.4).
Overfølsomhed over for temsirolimus, dets metabolitter (herunder sirolimus), polysorbat 80, eller over for et eller flere af hjælpestofferne i TORISEL.
Hypersensitivity to temsirolimus, its metabolites (including sirolimus), polysorbate 80, or to any of the excipients of TORISEL.
Børn Temsirolimus bør ikke anvendes til pædiatriske patienter på grund af utilstrækkelige sikkerhedsdata.
Paediatrics Temsirolimus is not recommended for use in paediatric patients due to insufficient data on safety.
Ældre Resultaterne af et fase- 3 forsøg har vist, at ældre patienter kan have større sandsynlighed for at få visse bivirkninger herunder ødemer og pneumoni.
Elderly Based on the results of a phase 3 study, elderly patients may be more likely to experience certain adverse reactions, including oedema and pneumonia.
Forsøg med patienter med varierende grad af nyreinsufficiens er ikke gennemført (se pkt.
Renal impairment Temsirolimus elimination by the kidneys is negligible; studies in patients with varying renal impairment have not been conducted (see section 4.2 and 5.2).
TORISEL er ikke undersøgt hos patienter i hæmodialyse.
TORISEL has not been studied in patients undergoing haemodialysis.
Leverinsufficiens Temsirolimus udskilles hovedsageligt gennem leveren.
3 Hepatic impairment Temsirolimus is cleared predominantly by the liver.
4. 2).
No data are currently available regarding the influence of hepatic dysfunction and/ or hepatic metastases on temsirolimus disposition (see section 4.2).
Intracerebral blødning Patienter med tumorer i centralnervesystemet (CNS) (primære CNS- tumorer eller metastaser), og/ eller patienter, som får antikoagulationsbehandling, kan have en forøget risiko for at udvikle intracerebral blødning (herunder med dødelig udgang), når de bliver behandlet med temsirolimus.
Intracerebral bleeding Patients with central nervous system (CNS) tumours (primary CNS tumours or metastases) and/ or receiving anticoagulation therapy may be at an increased risk of developing intracerebral bleeding (including fatal outcomes) while receiving therapy with temsirolimus.
4. 8).
Renal failure Renal failure (including fatal outcomes) has been observed in patients receiving TORISEL for advanced renal cell cancer and/ or with pre-existing renal insufficiency (see section 4.8).
Cataract Der er set cataract hos nogle patienter, som fik en kombination af temsirolimus og interferon- α.
Cataracts Cataracts have been observed in some patients who received the combination of temsirolimus and interferon-α.
4. 8).
Hypersensitivity/ infusion reactions Hypersensitivity/ infusion reactions (including some life-threatening and rare fatal reactions), including and not limited to flushing, chest pain, dyspnoea, hypotension, apnoea, loss of consciousness, hypersensitivity and anaphylaxis, have been associated with the administration of temsirolimus (see section 4.8).
Infusionen af temsirolimus bør afbrydes hos alle patienter med alvorlige reaktioner på infusionen, og der bør gives relevant, lægelig behandling.
Temsirolimus infusion should be interrupted in all patients with severe infusion reactions and appropriate medical therapy administered.
Hvis en patient trods præmedicineringen udvikler en overfølsomhedsreaktion under infusionen med TORISEL, skal infusionen stoppes og patienten observeres i mindst 30 til 60 minutter (afhængig af reaktionens sværhedsgrad).
If a patient develops a hypersensitivity reaction during the TORISEL infusion, despite the premedication, the infusion must be stopped and the patient observed for at least 30 to 60 minutes (depending on the severity of the reaction).
30 minutter før genoptagelsen af infusionen med TORISEL.
At the discretion of the physician, treatment may be resumed after the administration of an H1-receptor antagonist (diphenhydramine or similar antihistamine) and a H2-receptor antagonist (intravenous famotidine 20 mg or intravenous ranitidine 50 mg) approximately 30 minutes before restarting the TORISEL infusion.
Virkningen af kortikosteroider i denne sammenhæng er dog ikke fastslået.
Administration of corticosteroids may be considered; however, the efficacy of corticosteroid treatment in this setting has not been established.
Infusionen kan derefter genoptages med en langsommere hastighed (op til 60 minutter) og bør afsluttes inden for seks timer fra det tidspunkt, hvor TORISEL blev tilsat natriumklorid 9 mg/ ml (0, 9%) opløsningen til injektion.
The infusion may then be resumed at a slower rate (up to 60 minutes) and should be completed within six hours from the time that TORISEL is first added to sodium chloride 9 mg/ ml (0.9%) solution for injection.
Da det anbefales, at der indgives et H1- antihistamin til patienterne inden starten på den intravenøse temsirolimus- infusion, skal temsirolimus anvendes med forsigtighed til patienter med kendt overfølsomhed over for antihistaminer eller til patienter, der ikke kan få antihistaminer af andre lægelige grunde.
Because it is recommended that an H1 antihistamine be administered to patients before the start of the intravenous temsirolimus infusion, temsirolimus should be used with caution in patients with known hypersensitivity to the antihistamine or in patients who cannot receive the antihistamine for other medical reasons.
Overfølsomhedsreaktioner herunder anafylaktiske/ anafylaktoide reaktioner, angioødem, eksfoliativ dermatitis og allergisk vasculitis er blevet sat i forbindelse med peroral indgift af sirolimus.
Hypersensitivity reactions, including anaphylactic/ anaphylactoid reactions, angioedema, exfoliative dermatitis and hypersensitivity vasculitis, have been associated with the oral administration of sirolimus.
Hyperglykæmi/ glukoseintolerans/ diabetes mellitus Patienterne skal informeres om, at behandlingen med TORISEL kan være forbundet med en øgning af blodglukoseniveauet hos patienter med eller uden diabetes.
Hyperglycaemia/ glucose intolerance/ diabetes mellitus Patients should be advised that treatment with TORISEL may be associated with an increase in blood glucose levels in diabetic and non-diabetic patients.
I et klinisk forsøg rapporterede 26% af patienterne hyperglykæmi som bivirkning.
In a clinical trial, 26% of patients reported hyperglycaemia as an adverse event.
Dette kan medføre et behov for dosisøgning, eller start på insulin og/ eller behandling med hypoglykæmisk stof.
This may result in the need for an increase in the dose of, or initiation of, insulin and/ or hypoglycaemic agent therapy.
Infektioner Patienterne kan blive immunosupprimerede og skal overvåges omhyggeligt med hensyn til forekomst af infektioner, herunder opportunistiske infektioner.
4 Infections Patients may be immunosuppressed and should be carefully observed for the occurrence of infections, including opportunistic infections.
Interstitiel lungesygdom Der har været tilfælde med ikke- specifik interstitiel pneumonitis, blandt andet sjældne dødelige rapporter, der er forekommet hos patienter, der ugentlig fik TORISEL intravenøst.
Interstitial lung disease There have been cases of non-specific interstitial pneumonitis, including rare fatal reports, occurring in patients who received weekly intravenous TORISEL.
Nogle patienter var asymptomatiske, hvor pneumonitis blev fundet ved CT- scanning eller røntgenundersøgelse af thorax.
Some patients were asymptomatic with pneumonitis detected on computed tomography scan or chest radiograph.
Andre fremviste symptomer som f. eks. dyspnø, hoste og feber.
Others presented with symptoms such as dyspnoea, cough, and fever.
Nogle patienter behøvede seponering af TORISEL eller behandling med kortikosteroider og/ eller antibiotika, medens nogle patienter fortsatte behandlingen uden yderligere intervention.
Some patients required discontinuation of TORISEL or treatment with corticosteroids and/ or antibiotics, while some patients continued treatment without additional intervention.
Patienterne bør følges op med henblik på kliniske respiratoriske symptomer.
Patients should be followed for clinical respiratory symptoms.
4 Hyperlipæmi Brugen af TORISEL til patienter med renalcellecarcinom var forbundet med stigninger i serum - triglycerid og cholesterol.
Hyperlipaemia The use of TORISEL in renal cell carcinoma patients was associated with increases in serum triglycerides and cholesterol.
Hyperlipæmi blev i et klinisk forsøg rapporteret som bivirkning hos 27% af patienterne.
In a clinical trial, hyperlipaemia was reported as an adverse event in 27% of patients.
Dette kan kræve start på eller stigning i doseringen af lipid- sænkende stoffer.
This may require initiation, or increase, in the dose of lipid-lowering agents.
Serumcholesterol og triglycerider skal kontrolleres før og under behandlingen med TORISEL.
Serum cholesterol and triglycerides should be tested before and during treatment with TORISEL.
Der skal derfor udvises forsigtighed ved brugen af TORISEL i den perioperative periode.
Wound healing complications The use of TORISEL has been associated with abnormal wound healing; therefore, caution should be exercised with the use of TORISEL in the peri-surgical period.
4. 5).
Concomitant use of angiotensin-converting enzyme (ACE) inhibitors Angioneurotic oedema-type reactions (including delayed reactions occurring two months following initiation of therapy) have been observed in some patients who received temsirolimus and ACE inhibitors concomitantly (see section 4.5).
Stoffer, der inducerer CYP3A- metabolismen Stoffer som f. eks. carbemazepin, phenobarbital, phenytoin, rifampicin, rifabutin, rifapentin og prikbladet perikon er kraftige CYP3A4/ 5- induktorer og kan nedsætte den sammensatte eksposition af de aktive dele, temsirolimus og dets metabolit, sirolimus.
John’ s Wort are strong inducers of CYP3A4/ 5 and may decrease composite exposure of the active moieties, temsirolimus and its metabolite, sirolimus.
Kontinuerlig behandling udover 5- 7 dage med stoffer, der har et CYP3A4/ 5- induktionspotentiale, bør derfor undgås.
Therefore, continuous administration beyond 5-7 days with agents that have CYP3A4/ 5 induction potential should be avoided.
Stoffer, der hæmmer CYP3A- metabolismen Stoffer såsom proteasehæmmere (indinavir, nelfinavir, ritonavir), antimykotika, (som f. eks. itraconazol, ketoconazol, voriconazol), calciumkanalblokkere (f. eks. diltiazem, verapamil), makrolid - antibiotika (f. eks. clarithromycin, erythromycin) og cimetidin, grapefrugtjuice, aprepitant, fluvoxamin og nefazodon er stærke CYP3A4- hæmmere og kan øge blodkoncentrationerne af de aktive dele, temsirolimus og dets metabolit sirolimus.
Agents inhibiting CYP3A metabolism Agents such as protease inhibitors (indinavir, nelfinavir, ritonavir), antifungals (e. g., itraconazole, ketoconazole, voriconazole), calcium channel blockers (e. g., diltiazem, verapamil), macrolide antibiotics (e. g., clarithromycin, erythromycin), and cimetidine, grapefruit juice, aprepitant, fluvoxamine and nefazodone are strong CYP3A4 inhibitors and may increase blood concentrations of the active moieties, temsirolimus and its metabolite, sirolimus.
Samtidig behandling med stoffer, der har et kraftigt CYP3A4- hæmmende potentiale bør derfor undgås.
Therefore, concomitant treatment with agents that have strong CYP3A4 inhibition potential should be avoided.
4. 5).
Concomitant treatment with agents that have moderate CYP3A4 inhibition potential should be carried out with caution (see section 4.5).
Det bør overvejes at anvende alternative behandlinger med stoffer, der ikke har et CYP3A4- hæmmende potentiale.
Alternative treatments with agents that do not have CYP3A4 inhibition potential should be considered.
Vaccinationer Immunosuppressiva kan påvirke reaktionerne på vaccination.
Vaccinations Immunosuppressants may affect responses to vaccination.
Under behandlingen med TORISEL kan vaccinationer være mindre effektive.
During treatment with TORISEL, vaccination may be less effective.
Brugen af levende vaccine bør undgås under behandling med TORISEL.
The use of live vaccines should be avoided during treatment with TORISEL.
Eksempler på levende vacciner er: morbilli -, parotitis -, rubella -, oral polio -, BCG -, gul feber -, varicella - og TY21a tyfusvacciner.
Examples of live vaccines are: measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines.