FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant treatment of temsirolimus with these agents should be avoided (see section 4.4).
Danish: Samtidig behandling med temsirolimus og disse stoffer bør undgås (se pkt.
English: Concomitant treatment with moderate CYP3A4 inhibitors (e.g. aprepitant, erythromycin, fluconazole, verapamil, grapefruit juice) should only be administered with caution in patients receiving 25 mg and should be avoided in patients receiving temsirolimus doses higher than 25 mg (see section 4.5).
Danish: Samtidig behandling med moderate CYP3A4-hæmmere (f.eks. aprepitant, erythromycin, fluconazol, verapamil, grapefrugtjuice) bør gennemføres med forsigtighed hos patienter, som får 25 mg, og bør undgås hos patienter, som får højere doser temsirolimus end 25 mg (se pkt.
English: Months (97.5% CI)
Danish: Risikoratio (97,5 % CI)
English: Grades 3 and 4 thrombocytopenia and/or neutropenia have been observed in the MCL clinical trial (see section 4.8).
Danish: Der er observeret trombocytopeni og/eller neutropeni af grad 3 og 4 i det kliniske studie vedrørende mantlecellelymfom (se pkt.
English: Pericardial effusion (fluid around the heart that may require drainage and can affect the pumping of blood).
Danish: Væske omkring hjertet, som måske kræver anlæggelse af dræn, og som kan påvirke hjertets evne til at pumpe blodet rundt (perikardialt ekssudat).
English: The solution should be a clear to slightly turbid, colourless to light-yellow to yellow solution, essentially free from visual particulates.
Danish: Opløsningen skal være klar til let uklar, farveløs til lysegul til gul, i alt væsentligt fri for synlige partikler.
English: if you have mantle cell lymphoma and liver problems.
Danish: - hvis du har mantlecellelymfom og leverproblemer.
English: Leukopenia ** Lymphopenia
Danish: Almindelig Leukopeni**
English: Torisel concentrate and solvent should be inspected visually for particulate matter and discolouration prior to administration.
Danish: Torisel koncentrat og solvens skal inspiceres visuelt for partikler og misfarvning inden administration.
English: The final diluted solution in the bag or bottle should be inspected visually for particulate matter and discolouration prior to administration.
Danish: Den færdige infusionsvæske i posen eller flasken skal inspiceres for partikler og misfarvning inden administration.
English: Dose-limiting toxicities (Grade 3/4 erythematous maculopapular rash, gout/cellulitis requiring hospitalisation) were observed in 2 out of 3 patients treated in the first cohort of a Phase 1 study at doses of temsirolimus 15 mg intravenous per week and sunitinib 25 mg oral per day (Days 1-28 followed by a 2-week rest) (see section 4.5).
Danish: Dosisbegrænsende toksicitet (grad 3/4 erytematøs, makulopapuløst udslæt, urinsyregigt/cellulitis med behov for hospitalisering) blev observeret hos 2 ud af 3 patienter behandlet i første kohorte af et fase 1 studie ved doser på 15 mg intravenøs temsirolimus om ugen og 25 mg oral sunitinib om dagen (dag 128 fulgt af 2 ugers pause) (se pkt.
English: An increased incidence of angioneurotic oedema (including delayed reactions occurring two months following initiation of therapy) has been observed in patients who received temsirolimus or other mTOR inhibitors in combination with an ACE inhibitor (e.g. ramipril) and/or a calcium channel blocker (e.g. amlodipine) (see sections 4.4 and 4.8).
Danish: En øget forekomst af angioneurotisk ødem (herunder forsinkede reaktioner, der optræder to måneder efter behandlingsstart) er set hos patienter, der fik temsirolimus eller andre mTOR-hæmmere i kombination med en ACE-hæmmer (f.eks. ramipril) og/eller en calciumantagonist (f.eks. amplodipin) (se pkt.
English: The temsirolimus 175 mg (3 successive weekly doses) followed by 25 mg weekly treatment arm did not result in a significant increase in PFS when compared with investigator's choice (median 3.4 vs. 1.9 months, hazard ratio = 0.65, CI = 0.39, 1.10, p = 0.0618).
Danish: Behandlingsarmen med 175 mg temsirolimus (3 på hinanden følgende ugentlige doser) efterfulgt af 25 mg om ugen medførte ikke en signifikant stigning i den progressionsfrie overlevelse sammenlignet med investigators valg (median på 3,4 mod 1,9 måneder, risikoforhold = 0,65, konfidensinterval = 0,39; 1,10, p = 0,0618).
English: Clear glass vial (type 1), with butyl rubber stopper and a plastic flip-top closure sealed with aluminum containing 2.2 ml of solvent
Danish: Klart hætteglas (type 1) med butylgummiprop og en plastiktop til at vippe af, forseglet med aluminium indeholdende 2,2 ml solvens.
English: p = 0.0078).
Danish: PS = 0.
English: This medicine is not for children and adolescents below 18 years of age because advanced cancer of the kidney and mantle cell lymphoma are not relevant for these patients, and it did not work in other cancers.
Danish: Fremskreden nyrekræft og mantlecellelymfom er ikke relevant for denne patientgruppe, og lægemidlet virker ikke mod andre kræftformer.
English: You should tell your doctor or nurse immediately if you have symptoms of angioedema, such as swollen face, tongue or pharynx, and difficulty in breathing.
Danish: Kontakt straks læge eller sundhedspersonalet hvis du får symptomer på angioødem, f.eks. hævelse i ansigtet, tungen eller svælget og besvær med at trække vejret.
English: Temsirolimus should be used with caution when treating patients with hepatic impairment.
Danish: Leverinsufficiens Temsirolimus skal anvendes med forsigtighed ved behandling af patienter med nedsat leverfunktion.
English: The amount of alcohol in this medicinal product may impair the ability to drive or use machines (see section 4.7).
Danish: Alkoholindholdet i dette lægemiddel kan ændre virkningen af andre lægemidler, og det kan påvirke evnen til at køre eller betjene maskiner (se pkt.
English: Each pack of Torisel contains one glass vial of 1.2 ml of concentrate and one glass vial of 2.2 ml of solvent.
Danish: Hver pakning med Torisel indeholder et hætteglas med butylgummiprop med 1,2 ml koncentrat og et hætteglas med 2,2 ml solvens.
English: Temsirolimus has not been studied in patients undergoing haemodialysis.
Danish: Temsirolimus er ikke undersøgt hos patienter i hæmodialyse.
English: Abdominal distension
Danish: Abdominal udspilning
English: No dose adjustment is recommended for patients with MCL and mild hepatic impairment.
Danish: Der anbefales ingen dosisjustering hos patienter med MCL og let leverinsufficiens.
English: Clear glass vial (type 1), with butyl rubber stopper and a plastic flip-top closure sealed with aluminum containing 1.2 ml of concentrate
Danish: Klart hætteglas (type 1) med butylgummiprop og en plastiktop til at vippe af, forseglet med aluminium indeholdende 1,2 ml koncentrat.
English: The adverse reactions reported by the highest percentage of patients were haematologic (anaemia, leukopenia, neutropenia, and thrombocytopenia), metabolic (hypercholesterolemia, hyperlipaemia, hyperglycaemia, increase of serum aspartate amino transferase (AST) and serum alanine aminotransferase (ALT) plasma levels), and digestive (mucositis, stomatitis, nausea, and vomiting).
Danish: De bivirkninger, der blev rapporteret hos den største procentdel af patienterne, var hæmatologiske (anæmi, leukopeni, neutropeni og trombocytopeni), metaboliske (hyperkolesterolæmi, hyperlipidæmi, hyperglykæmi, øgede serum-aspartataminotransferase-(ASAT)- og serum-alaninaminotransferase(ALAT)-plasmaniveauer samt gastrointestinale (mucositis, stomatitis, kvalme og opkastning).
English: Torisel is unlikely to influence the ability to drive and use machines.
Danish: Det er usandsynligt, at Torisel har indflydelse på arbejdssikkerheden eller evnen til at færdes sikkert i trafikken.
English: 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).
Danish: Overfølsomhedsreaktioner/reaktioner på infusionen (herunder nogle livstruende og sjældne, letale reaktioner) omfattende - men ikke begrænset til - rødme, brystsmerter, dyspnø, hypotension, apnø, bevidsthedstab, overfølsomhed og anafylaksi er blevet sat i forbindelse med indgift af temsirolimus (se pkt.
English: The primary efficacy endpoint was ORR, and OS was also evaluated.
Danish: Det primære effektendemål var ORR.
English: In the 25 mg arm (n = 36), all patients had metastatic disease; 4 (11%) had no prior chemo- or immunotherapy; 17 (47%) had one prior treatment, and 15 (42%) had 2 or more prior treatments for RCC. Twenty-seven (27, 75%) had undergone a nephrectomy.
Danish: 17 (47%) havde fået en behandling tidligere og 15 (42%) havde fået 2 eller flere forudgående behandlinger for RCC. Syvogtyve (27, 75%) havde fået foretaget nephrectomi.
English: The most serious reactions observed with temsirolimus in clinical trials are hypersensitivity/infusion reactions (including some life-threatening and rare fatal reactions), hyperglycaemia/glucose intolerance, infections, interstitial lung disease (pneumonitis), hyperlipaemia, intracranial haemorrhage, renal failure, intestinal perforation, wound healing complication, thrombocytopenia, neutropenia (including febrile neutropenia), pulmonary embolism.
Danish: De mest alvorlige bivirkninger, der er blevet observeret med temsirolimus i kliniske studier, er allergiske reaktioner/reaktioner ved infusionen (herunder nogle livstruende og sjældne, letale reaktioner), hyperglykæmi/glucoseintolerans, infektioner, interstitiel lungesygdom (pneumoni), hyperlipæmi, intrakranial blødning, nyreinsufficiens, perforering af tarm, komplikationer ved sårheling, trombocytopeni, neutropeni (herunder febril neutropeni), lungeemboli.
English: The Torisel concentrate must first be diluted with 1.8 ml of the supplied solvent to achieve a concentration of 10 mg/ml before administration in sodium chloride 9 mg/ml (0.9%) solution for injection (see dilution instructions at the end of the package leaflet).
Danish: Torisel-koncentratet skal først fortyndes med 1,8 ml af den medfølgende solvens for at opnå en koncentration på 10 mg/ml før injektion i natriumchlorid 9 mg/ml (0,9%)-injektionsvæske (se fortyndingsvejledningen sidst i indlægssedlen).
English: Use of temsirolimus in patients with MCL with moderate or severe hepatic impairment.
Danish: Anvendelse af temsirolimus til patienter med MCL og moderat til svær leverinsufficiens.
English: Very common Neutropenia Thrombocytopenia** Anaemia
Danish: Trombocytopeni** Anæmi
English: Torisel 30 mg concentrate and solvent for solution for infusion temsirolimus
Danish: Torisel 30 mg koncentrat og solvens til infusionsvæske, opløsning temsirolimus
English: Serious adverse reactions observed in clinical trials of temsirolimus for advanced RCC, but not in clinical trials of temsirolimus for MCL include: anaphylaxis, impaired wound healing, renal failure with fatal outcomes, and pulmonary embolism.
Danish: Alvorlige bivirkninger, set i kliniske r af temsirolimus til fremskredent RCC, men ikke i kliniske studie af temsirolimus til MCL, omfatter: anafylaksi, forsinket sårheling, nyresvigt med letal udgang og lungeemboli.
English: Each vial of concentrate contains 30 mg of temsirolimus.
Danish: Et hætteglas med koncentrat indeholder 30 mg temsirolimus.
English: Your doctor may delay the administration of Torisel until the wound is fully recovered as this medicine could interfere with the healing processes of pre-existing wounds.
Danish: - hvis du er blevet opereret for nylig, vil lægen måske vente med at sætte Toriselbehandligen i gang indtil såret er helet, da dette lægemiddel kan forsinke sårhelingen.
English: Use a new vial.
Danish: Tag et nyt hætteglas.
English: You may be more likely to have certain side effects, including swelling of your face, diarrhoea, pneumonia, anxiety, depression, shortness of breath, decreased number of white cells in the blood, muscle pain, change in the sense of taste, upper respiratory infection, fluid around the lungs, sores and inflammation in the mouth and/or the digestive tract, runny nose, dizziness and infections.
Danish: Der kan være større risiko for at få visse bivirkninger herunder hævelse i ansigtet, diaré, lungebetændelse, angst, depression, åndenød, nedsat antal hvide blodlegemer, muskelsmerter, smagsforstyrrelser, øvre luftvejsinfektioner, væske omkring lungerne, sår og infektioner i munden og/eller fordøjelseskanalen og løbende næse, svimmelhed og infektioner.
English: • Inject the withdrawn volume rapidly into 250 ml of sodium chloride 9 mg/ml (0.9%) solution for injection to ensure adequate mixing.
Danish: • Injicér den optrukne mængde hurtigt i 250 ml natriumchlorid 9 mg/ml (0,9%) injektionsvæske, opløsning, for at sikre tilstrækkelig blanding.
English: Very common side effects (may affect more than 1 in 10 people):
Danish: Meget almindelige bivirkninger (forekommer hos mere end 1 ud af 10 patienter):
English: Men with partners of childbearing potential should use medically acceptable contraception while receiving Torisel.
Danish: Mænd med partnere i den fødedygtige alder, skal anvende en sikker svangerskabsforebyggende metode, medens de får Torisel.
English: Renal impairment/renal failure
Danish: Nyreinsufficiens/nyresvigt
English: if you experience any excessive thirst or increased frequency and quantity of urination.
Danish: - hvis du føler overdreven tørst eller hvis du skal tisse hypppigere eller mængden af urin stiger.
English: Cataracts have been observed in some patients who received the combination of temsirolimus and interferon-α (IFN-α).
Danish: Der er set katarakt hos nogle patienter, som fik en kombination af temsirolimus og interferon- (IFN
English: Tell your doctor if you experience any excessive thirst or increased frequency and quantity of urination.
Danish: Fortæl det altid til lægen, hvis du bliver overdrevent tørstig, skal lade vandet hyppigere eller mængden af urin bliver større.
English: The admixture of Torisel in sodium chloride 9 mg/ml (0.9%) solution for injection should be protected from excessive room light and sunlight.
Danish: Tilsætningen af Torisel til natriumchlorid 9 mg/ml (0,9%) injektionsvæske skal beskyttes mod kraftig rumbelysning og sollys.
English: Torisel contains ethanol (alcohol)
Danish: Torisel indeholder alkohol
English: Intracerebral bleeding
Danish: Intracerebral blødning
English: Your doctor may prescribe you insulin and/or oral antidiabetic agent therapy.
Danish: Lægen kan ordinere insulin og/eller tabletbehandling mod sukkersyge.
English: if you have or have had kidney problems.
Danish: - hvis du har eller har haft nyreproblemer.
English: During in vitro temsirolimus metabolism studies, sirolimus, seco-temsirolimus and seco-sirolimus were observed; additional metabolic pathways were hydroxylation, reduction and demethylation.
Danish: Ved in vitro studier af temsirolimus-metabolismen blev der observeret sirolimus, seco-temsirolimus og seco-sirolimus.
English: Cases of pneumocystis jiroveci pneumonia (PCP) some with fatal outcomes, have been reported in patients who received temsirolimus, many of whom also received corticosteroids or other immunosuppressive agents.
Danish: Der er rapporteret tilfælde af pneumocystis jiroveci pneumoni (PJP), nogle med dødeligt udfald, hos patienter, som har fået temsirolimus.
English: (CYPRUS BRANCH) Tηλ: +357 22 817690
Danish: PFIZER ΕΛΛΑΣ A.E. (CYPRUS BRANCH) T :+357 22 817690
English: The concentrate is a clear, colourless to light-yellow solution, free from visible particulates.
Danish: Koncentratet er en klar, farveløs til lysegul opløsning, fri for synlige partikler.
English: Uncommon Intracranial haemorrhage
Danish: Ikke almindelig Intrakranial blødning
English: For renal cancer, the recommended dose is 25 mg infused (as a drip) over a 30 to 60 minute period once weekly.
Danish: Til nyrekræft er den anbefalede dosis 25 mg tilført (som drop) over en 30- til 60-minutters periode en gang om ugen.
English: The concentrate is a clear, colourless to light-yellow solution.
Danish: Koncentratet er en klar, farveløs til lysegul opløsning.
English: You should seek medical advice immediately if you experience shortness of breath, chest pain, coughing up blood, fast heartbeat, nausea, fainting, sweating, wheezing, and clammy or bluish skin.
Danish: Kontakt straks læge, hvis du bliver stakåndet, får brystsmerter, hoster blod op, får hurtig hjertebanken, kvalme, besvimer, sveder, hvæsende vejrtrækning og klam blålig hud.
English: For 7 patients with severe hepatic impairment (ODWG, group D) receiving the 10 mg dose of temsirolimus, the mean AUC of temsirolimus was ~1.7-fold higher compared to 7 patients with mild hepatic impairment (ODWG, group B).
Danish: Hos 7 patienter med svær leverinsufficiens, som fik en dosis på 10 mg temsirolimus, var middel-AUC for temsirolimus ~1,7 gange højere sammenlignet med 7 patienter med let leverinsufficiens.
English: This may result in the need for insulin and/or oral antidiabetic agent therapy.
Danish: Det kan gøre det nødvendigt med insulin og/eller anden behandling mod diabetes.
English: The vial of concentrate must first be diluted with 1.8 ml of the supplied solvent to achieve a concentration of temsirolimus of 10 mg/ml.
Danish: Hætteglasset med koncentrat skal først fortyndes med 1,8 ml af den medfølgende solvens for at opnå en koncentration på 10 mg temsirolimus/ml.
English: After first dilution of the concentrate with 1.8 ml of solvent, the concentration of temsirolimus is 10 mg/ml (see section 4.2).
Danish: Efter første fortynding af koncentratet med 1,8 ml solvens er koncentrationen af temsirolimus 10 mg/ml (se pkt.
English: Rare side effects (may affect up to 1 in 1,000 people):
Danish: Sjældne bivirkninger (forekommer hos op til 1 ud af 1.000 patienter):
English: The other ingredients in the concentrate are anhydrous ethanol, all-rac-α-tocopherol (E 307), propylene glycol and citric acid (E 330).
Danish: Øvrige indholdsstoffer i koncentratet er vandfri ethanol, helt rac--tocopherol (E 307), propylenglycol og citronsyre (E 330).
English: In patients 65 or older, median overall survival was 8.6 months (95% CI 6.4, 11.5) with a hazard ratio of 1.15 (95% CI 0.78, 1.68) compared with those treated with IFN-α.
Danish: Blandt patienterne, der var yngre end 65, var den mediane samlede overlevelse 12 måneder (95% CI 9,9; 14,2) med en risikoratio på 0,67 (95% CI 0,52; 0,87) sammenlignet med dem, der blev behandlet med IFN-Blandt patienterne, der var 65 eller ældre, var den mediane samlede overlevelse 8,6 måneder (95% CI 6,4; 11,5) med en risikoratio på 1,15 (95% CI 0,78; 1,68) sammenlignet med dem, der blev behandlet med IFN-
English: General feeling of weakness, chills, swelling due to fluid retention, pain (including abdominal, back, chest and joint pain), feeling sick to the stomach (nausea and vomiting), diarrhoea, constipation , headache, fever, sores and inflammation in the mouth and/or the digestive tract, cough, pneumonia, nose bleed, rash, itching, dry skin, decreased appetite, shortness of breath, low levels of potassium in the blood (which may cause muscle weakness), low red blood cell count, decreased number of a type of white blood cells which is associated with an increased risk of infection, high blood sugar, high cholesterol, high triglycerides abscess, infections ( including eye infection, flu, viral infections, bronchitis), abnormal kidney function (including kidney failure), blood tests that show changes in the way the kidney is working, change in the sense of taste, difficulty falling asleep, low number of platelets which may cause bleeding and bruising.
Danish: Almindelig svaghedsfølelse, kuldegysninger, hævelse på grund af væskeophobning, smerter (herunder mave-, ryg-, bryst- og ledsmerter), en følelse af at være syg (kvalme og opkastning), diaré, forstoppelse, hovedpine, feber, sår og betændelse i munden og/eller fordøjelseskanalen, hoste, lungebetændelse, næseblod, udslæt, kløe, tør hud, appetitløshed, åndenød, lavt indhold af kalium i blodet (hvilket kan meføre muskelsvaghed), lavt antal røde blodlegemer, nedsat antal hvide blodlegemer, hvilket kan medføre øget risiko for infektion, højt blodsukker, højt kolesterol, højt fedtstofindhold i blodet, bylder, infektioner (herunder øjeninfektion, influenza, virusinfektioner, bronkitis), anormal nyrefunktion (herunder nyresvigt), ændringer i nyrefunktionen (ses i blodprøver), smagsforstyrrelser, besvær med at falde i søvn, lavt antal blodplader, som kan give blødninger og blå mærker.
English: For patients receiving the higher dose of Torisel for the treatment of mantle cell lymphoma, the amount of alcohol in this medicine may impair your ability to drive or use machines (see section below “Torisel contains ethanol [alcohol]”).
Danish: De patienter, der får den høje dosis Torisel til behandling af mantlecellelymfom, kan på grund af indholdet af alkohol i lægemidlet opleve en påvirkning af deres evne til at køre eller til at betjene maskiner (se nedenstående afsnit “Torisel indeholder ethanol (alkohol)”Advarsler og forsigtighedsregler og Trafik- og arbejdssikkerhed).
English: Carcinogenicity studies have not been conducted with temsirolimus; however, sirolimus, the major metabolite of temsirolimus in humans, was carcinogenic in mice and rats.
Danish: Sirolimus hovedmetabolitten fra temsirolimus hos mennesker var imidlertid carcinogen hos mus og rotter.
English: One vial of Torisel concentrate contains 30 mg of temsirolimus: when the 1.2 ml concentrate is combined with 1.8 ml of the supplied solvent, a total volume of 3.0 ml is obtained and the concentration of temsirolimus will be 10 mg/ml.
Danish: Et hætteglas Torisel koncentrat indeholder 30 mg temsirolimus: Når de 1,2 ml koncentrat blandes med de 1,8 ml af den medfølgende solvens, fås et totalt volumen på 3,0 ml og koncentrationen af temsirolimus vil blive 10 mg/ml.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Torisel
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E)
English: Runny nose, gum redness and swelling, mouth pain (including sores inside the mouth), stomach bloating, sore throat, high blood pressure, pink eye including watery eye disorder, taste loss, redness and swelling of the follicles in the skin, allergic reactions, severe scaling of the skin, increased blood clotting (including thrombosis of the veins), low levels of calcium in the blood, low levels of phosphates in the blood, upper respiratory infections, inflammation of the lung, fluid in the chest cavity, infection in the blood, dehydration, agitation, depression, numbness and tingling of the skin, dizziness, sleepiness, bleeding (from the lips, mouth, stomach or intestines), inflammation of the lining of the stomach, trouble with swallowing, skin bleeding (bruising), small pin-point haemorrage, nail disorder, acne, yeast infection, fungal infection, urinary tract infections, cystitis, blood tests that show changes in the way the liver is working, high blood fats other than triglycerides, diabetes, muscle pain.
Danish: Løbenæse, rødme og hævelse af gummerne, smerter i munden (herunder sår i munden), oppustet mave, ondt i halsen, højt blodtryk, rødt øje, herunder øjne, der løber i vand, tab af smagssansen, rødme og hævelse af hudens follikler, allergiske reaktioner, svær skældannelse på huden, øget risiko for blodpropper (herunder blodpropper i venerne), lavt indhold af kalcium i blodet, lavt indhold af fosfat i blodet, øvre luftvejsinfektioner, lungebetændelse, væske i brysthulen, infektion i blodet, væskemangel, ophidselse, depression, følelsesløshed og prikken i huden, svimmelhed, søvnighed, blødning (fra læber, mund, maven eller tarmene), betændelse i maveslimhinden, synkebesvær, blødning i huden (blå mærker), små punktformede blødninger, neglesygdomme, akne, gærsvampeinfektion, svampeinfektion, urinvejsinfektion, blærebetændelse, ændringer i leverfunktionen (se i blodprøver), højt indhold af fedt og triglycerider i blodet, diabetes, muskelsmerter.
English: The excretion of temsirolimus in milk has not been studied in animals.
Danish: Der er ikke foretaget undersøgelser på dyr af udskillelse af temsirolimus i mælk.