FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you have experienced in the past a combination of any of the following symptoms: rash on face or extended rash, red skin, high fever, flu-like symptoms, enlarged lymph nodes (signs of severe skin reaction called drug reaction with eosinophilia and systemic symptoms (DRESS), see also section 4 “Possible side effects”).
Danish: • hvis du tidligere har oplevet en kombination af nogen af følgende symptomer: udslæt i ansigtet eller udbredt udslæt, hudrødme, høj feber, influenzalignende symptomer, forstørrede lymfeknuder (tegn på en alvorlig hudreaktion, der kaldes lægemiddelfremkaldt reaktion med eosinofili og systemiske symptomer (DRESS), se også punkt 4 “Bivirkninger”).
English: All ADRs/Frequency
Danish: Alle bivirkninger/hyppighed
English: Repeated oral administration of 4 and 6 mg/kg/day to monkeys for up to 20 weeks produced mortality and significant toxicity (marked weight loss, reduced red and white blood cell and platelet counts, multiple organ haemorrhage, gastrointestinal tract inflammation, lymphoid, and bone marrow atrophy).
Danish: Gentagen oral administration af 4 og 6 mg/kg/dag til aber i op til 20 uger forårsagede dødelighed og væsentlig toksicitet (udpræget vægttab, reduktion af røde og hvide blodlegemer og trombocyttal, blødning fra flere organer, inflammation af mavetarmkanalen, lymfom- og knoglemarvsatrofi).
English: Infection◊, Urinary tract infection◊,*, Lower respiratory tract infection, Lung infection◊
Danish: Infektion◊, urinvejsinfektion◊,*, nedre luftvejsinfektion, lungeinfektion◊
English: Uncommon Hypercoagulation, Coagulopathy
Danish: Hyperkoagulation, koagulopati
English: If you take more lenalidomide than you should If you take more lenalidomide than was prescribed, tell your doctor immediately.
Danish: Hvis du har taget for mange lenalidomid kapsler Hvis du har taget flere lenalidomid kapsler, end du bør ifølge recepten, skal du straks fortælle det til lægen.
English: Tell your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in your stool, or changes in bowel habits.
Danish: Fortæl det til lægen, hvis du får svære mavesmerter, feber, kvalme, opkastning, blod i afføringen eller ændret afføringsmønster.
English: If powder from lenalidomide makes contact with the skin, the skin should be washed immediately and thoroughly with soap and water.
Danish: Hvis pulveret med lenalidomid får kontakt med huden, skal huden straks vaskes grundigt med sæbe og vand.
English: • Breakdown of the wall of the stomach or gut.
Danish: • Nedbrydning af mave- eller tarmvæggen.
English: The serious adverse reactions observed more frequently (≥5%) with lenalidomide maintenance than placebo were:
Danish: De alvorlige bivirkninger, som blev observeret hyppigere (≥ 5 %) med lenalidomidvedligeholdelsesbehandling end med placebo, var:
English: A possible cross-reaction between lenalidomide and thalidomide has been reported in the literature.
Danish: Der er i litteraturen rapporteret om en mulig krydsreaktion mellem lenalidomid og thalidomid.
English: • If your partner becomes pregnant whilst you are taking lenalidomide , you should inform your doctor immediately.
Danish: • Hvis din partner bliver gravid, mens du tager lenalidomid, skal du omgående informere lægen.
English: The major dose limiting toxicities (DLT )of lenalidomide include neutropenia and thrombocytopenia.
Danish: Lenalidomids primære, dosisbegrænsende toksiciteter er neutropeni og trombocytopeni.
English: • Use in patients with hepatic and/or renal impairment
Danish: • Anvendelse hos patienter med nedsat lever- og/eller nyrefunktion
English: In these studies, rabbits were administered 3, 10 and 20 mg/kg/day orally.
Danish: I disse studier fik kaninerne lenalidomid oralt i doser på 3, 10 og 20 mg/kg/dag.
English: The efficacy of contraceptive steroids may be reduced during co-treatment with dexamethasone (see section 4.5).
Danish: Præventionssteroiders virkning kan muligvis være nedsat ved samtidig behandling med dexamethason (se pkt.
English: • A condition affecting the skin caused by inflammation of small blood vessels, along with pain in the joints and fever (leukocytoclastic vasculitis).
Danish: • En sygdom, som påvirker huden og forårsages af en betændelseslignende reaktion i de små blodkar, sammen med smerter i leddene og feber (leukocytoklastisk vaskulitis).
English: In the lenalidomide/low dose dexamethasone group, 20 patients (9.1%) underwent at least one dose interruption compared to 65 patients (29.3%) in the lenalidomide/standard dose dexamethasone arm.
Danish: I gruppen med lenalidomid/Lavdosis dexamethason gennemgik 20 patienter (9,1 %) mindst én dosisafbrydelse, sammenlignet med 65 patienter (29,3 %) i armen med lenalidomid/standarddosis dexamethason.
English: Dexamethasonea
Danish: Dexamethasona
English: • Venous thromboembolism (deep vein thrombosis, pulmonary embolism) (see section 4.4)
Danish: • Venøs tromboemboli (dyb venetrombose (DVT), lungeemboli) (se pkt.
English: Very Common Rashes, Pruritus
Danish: Meget almindelig Udslæt, pruritus
English: Return to ≥ 1 x 109/L when neutropenia is the only observed toxicity
Danish: Vender tilbage til ≥ 1 x 109/l, når neutropeni er den eneste observerede toksicitet
English: Check list for physicians ensuring that patients receive the appropriate counselling concerning the treatment, contraceptive methods and pregnancy prevention appropriate for their sex and childbearing status
Danish: Tjekliste til læger for at sikre at patienter modtager passende rådgivning angående behandlingen, præventionsmetoder og beskyttelse mod graviditet i overensstemmelse med køn og fertilitet Formularer til rapportering af bivirkninger
English: 0.25 mg/kg ª If neutropenia is the only toxicity at any dose level, add granulocyte colony stimulating factor (G-CSF) and maintain the dose level of lenalidomide
Danish: 0,25 mg/kg ª Hvis neutropeni er den eneste toksicitet for et af dosisniveauerne, tilføjes granulocyt-kolonistimulerende faktor (G-CSF), og dosisniveauet for lenalidomid opretholdes
English: Pharmacotherapeutic group: Immunosuppressants, Other immunosuppressants.
Danish: Farmakoterapeutisk klassifikation: Immunsuppressiva.
English: • Neutropenia
Danish: • Neutropeni
English: No dose adjustment is proposed for patients older than 75 years who are treated with lenalidomide in combination with melphalan and prednisone.
Danish: Ingen dosisjustering foreslås for patienter over 75 år, som behandles med lenalidomid i kombination med melphalan og prednison.
English: Educational Brochures for patients
Danish: Oplysningsbrochurer til patienter
English: Dispensing of lenalidomide to women of childbearing potential should occur within 7 days of the prescription and following a medically supervised negative pregnancy test result.
Danish: Udlevering af lenalidomid til kvinder i den fertile alder bør finde sted inden for 7 dage efter ordinationen, og efter en sundhedsperson har konstateret en negativ graviditetstest.
English: Common Hypotension◊, Hypertension, Ecchymosis^
Danish: Hypotension◊, hypertension, ekkymose^
English: The following table is derived from data gathered during NDMM studies in patients who have undergone ASCT treated with lenalidomide maintenance.
Danish: Grundlaget for nedenstående tabel er data indsamlet under NDMM-studier hos patienter, der har gennemgået ASCT og er i vedligeholdelsesbehandling med lenalidomid.
English: Complete response and overall response rates in the len/dex arm were also significantly higher than the placebo/dex arm in both studies.
Danish: Frekvenserne for fuldstændig respons og samlet respons i len/dexarmen var væsentligt højere end i placebo/dex-armen i begge studier.
English: You must follow the Lenalidomide Pregnancy Prevention Programme
Danish: Du skal følge ”Programmet til svangerskabsforebyggelse” for lenalidomid.
English: Patients with known risk factors - including prior thrombosis - should be closely monitored, and action should be taken to try to minimize all modifiable risk factors (eg.
Danish: Patienter med kendte risikofaktorer, herunder tidligere trombose, bør monitoreres nøje, og der bør træffes foranstaltninger til at forsøge at minimere alle de risikofaktorer, som kan ændres (f.eks. rygning, hypertension og hyperlipidæmi).
English: Uncommon Angioedema
Danish: Ikke almindelig Angioødem
English: • Chest pain or leg pain
Danish: • Smerter i brystet eller benene
English: Soft tissue and skeletal variations in the foetuses were also observed at 10 and 20 mg/kg/day.
Danish: Variationer i bløddele og skeletter hos fostre sås ved 10 og 20 mg/kg/dag.
English: Common Febrile neutropenia^,◊, Pancytopenia◊
Danish: Almindelig Febril neutropeni^,◊, pancytopeni◊
English: • Numbness, tingling or burning sensation to the skin, pains in hands or feet, dizziness, tremor,
Danish: • Følelsesløshed, prikkende eller brændende fornemmelse i huden, smerter i hænder eller fødder,
English: changes in the way things taste
Danish: svimmelhed, rysten, ændringer i den måde, mad smager på
English: Effective measures to avoid pregnancy must be taken (see sections 4.4 and 4.6).
Danish: Der skal tages effektive forholdsregler for at undgå graviditet (se pkt.
English: Overall response: CR, VGPR, or PR Duration of response (months) Mediana (95% CI)b
Danish: Samlet respons: CR, VGPR eller PR Varighed af respons - (måneder) Mediana (95 % CI)b
English: • Leg pain (which could be a symptom of thrombosis), chest pain or breathlessness (which may be a symptom of blood clots in the lungs, called pulmonary embolism)
Danish: • Smerter i benene (der kan være et symptom på blodprop), brystsmerter eller åndenød (der kan være et symptom på blodpropper i lungerne, hvilket kaldes lungeemboli)
English: The pharmacokinetics of lenalidomide was studied in subjects with renal impairment due to nonmalignant conditions.
Danish: Lenalidomids farmakokinetik blev undersøgt hos personer med nedsat nyrefunktion, der skyldes ikkemaligne sygdomme.
English: Common Hyperthyroidism
Danish: Almindelig Hypertyroidisme
English: • Appetite lostLow levels of potassium in the blood
Danish: • Lavt kaliumindhold i blodet
English: • Ovulation inhibitory progesterone-only pills (i.e. desogestrel)
Danish: • P-piller kun med ægløsningshæmmende progestogen (dvs. desogestrel)
English: Common Atrial fibrillation◊, Bradycardia
Danish: Almindelig Atrieflimren◊, bradykardi
English: Co-administration of a single 25 mg dose of warfarin had no effect on the pharmacokinetics of lenalidomide.
Danish: Samtidig administration af en enkelt dosis på 25 mg warfarin havde ingen virkning på farmakokinetikken for lenalidomid.
English: Criteria for women of non-childbearing potential
Danish: Kriterier for, at kvinder ikke er fertile
English: • Hives, rashes, swelling of eyes, mouth or face, difficulty breathing, or itching, which may be symptoms of an allergic reaction
Danish: • Nældefeber, hævelse af øjne, mund eller ansigt, vejrtrækningsbesvær eller kløe, hvilket kan være symptomer på en allergisk reaktion
English: • Guidance on handling lenalidomide for patients, caregivers and family members
Danish: • Vejledning til patienter, omsorgspersoner og familiemedlemmer i håndtering af lenalidomid
English: Therefore, monitoring of the digoxin concentration is advised during lenalidomide treatment.
Danish: Digoxin-koncentrationen bør derfor monitoreres under behandlingen med lenalidomid.
English: Gastrointestinal perforations have been reported during treatment with lenalidomide.
Danish: Der er rapporteret om gastrointestinal perforation under behandling med lenalidomid.
English: Co-administration of single or multiple doses of dexamethasone (40 mg once daily) has no clinically relevant effect on the multiple dose pharmacokinetics of lenalidomide (25 mg once daily).
Danish: Samtidig administration af enkelte eller flere doser dexamethason (40 mg én gang dagligt) har ingen klinisk relevant virkning på farmakokinetikken af lenalidomid efter gentagne doser (25 mg én gang dagligt).
English: CI = confidence interval; CR = complete response; HR = Hazard Rate; M = melphalan; NE = not estimable; OS = overall survival; p = placebo; P = prednisone;
Danish: CI = konfidensinterval, CR = komplet respons, HR = hazard rate, M = melphalan, NE = kan ikke estimeres, OS = samlet overlevelse, p = placebo, P = prednison,
English: • Bleeding from the gums, stomach, or bowels
Danish: • Blødning fra gummerne, maven eller tarmene
English: Lenalidomide Accord hard capsules contain lactose.
Danish: Lenalidomide Accord hårde kapsler indeholder lactose.
English: Population pharmacokinetic analyses included patients with mild hepatic impairment (N=16, total bilirubin >1 to ≤1.5 x ULN or AST > ULN) and indicate that mild hepatic impairment does not influence lenalidomide clearance (exposure in plasma).
Danish: Populationsfarmakokinetiske analyser omfattede patienter med let nedsat leverfunktion (N=16, total bilirubin > 1 til ≤1,5 x ULN eller ASAT > ULN) og indikerede, at let nedsat leverfunktion ikke påvirker lenalidomids clearance (eksponering i plasma).
English: These cells collect in the bone marrow and divide, becoming out of control.
Danish: Disse celler ophobes i knoglemarven og gennemgår ukontrollerede celledelinger.
English: Newly diagnosed multiple myeloma - in patients who have had a bone marrow transplant Lenalidomide Accord is used on its own as maintenance therapy after patients have recovered enough following a bone marrow transplant.
Danish: Nyligt diagnosticeret myelomatose - hos patienter, som har gennemgået knoglemarvstransplantation Lenalidomide Accord anvendes som eneste lægemiddel til vedligeholdelsesbehandling, når patienterne er tilstrækkeligt restitueret efter en knoglemarvstransplantation.
English: If pregnancy occurs in a partner of a male patient taking lenalidomide, it is recommended to refer the female partner to a physician specialised or experienced in teratology for evaluation and advice.
Danish: Hvis en kvindelig partner til en mandlig patient, som tager lenalidomid, bliver gravid, anbefales det at henvise den kvindelige partner til en læge med speciale eller erfaring i teratologi til vurdering og rådgivning.
English: For male patients taking lenalidomide, pharmacokinetic data has demonstrated that lenalidomide is present in human semen at extremely low levels during treatment and is undetectable in human semen 3 days after stopping the substance in the healthy subject (see section 5.2).
Danish: For mandlige patienter, som tager lenalidomid, har farmakokinetiske data vist, at lenalidomid er til stede i human sæd i ekstremt små mængder under behandlingen, og at stoffet ikke kan påvises i human sæd 3 dage efter seponering hos raske forsøgspersoner (se pkt.
English: In an in vitro study with human hepatocytes, lenalidomide, at various concentrations tested did not induce CYP1A2, CYP2B6, CYP2C9, CYP2C19 and CYP3A4/5.
Danish: I et in vitro-studie med humane hepatocytter inducerede lenalidomid i de forskellige undersøgte koncentrationer ikke CYP1A2, CYP2B6, CYP2C9, CYP2C19 og CYP3A4/5.
English: The percentage of multiple myeloma patients aged 65 or over was not significantly different between the lenalidomide/dexamethasone and placebo/dexamethasone groups.
Danish: Der var ingen væsentlig forskel i procentdelen af patienter med myelomatose i alderen 65 år eller derover i lenalidomid/dexamethason- og placebo/dexamethason-grupperne.
English: Return to ≥ 0.5 x 109/L when dose-dependent haematological toxicities other than neutropenia are observed
Danish: Vender tilbage til ≥ 0,5 x 109/l, når andre dosisafhængige hæmatologiske toksiciteter end neutropeni observeres
English: Common Vasculitis
Danish: Almindelig Vaskulitis
English: Cases of allergic reaction/hypersensitivity reactions have been reported in patients treated with lenalidomide (see section 4.8).
Danish: Der er rapporteret om tilfælde af allergiske reaktioner/overfølsomhedsreaktioner hos patienter i behandling med lenalidomid (se pkt.
English: • Description and management of neutropenia and thrombocytopenia including incidence rates from clinical trials
Danish: • Beskrivelse og håndtering af neutropeni og trombocytopeni, herunder frekvensen i kliniske forsøg
English: The serious adverse reactions observed more frequently (≥5%) with melphalan, prednisone and lenalidomide followed by lenalidomide maintenance (MPR+R) or melphalan, prednisone and lenalidomide followed by placebo (MPR+p) than melphalan, prednisone and placebo followed by placebo (MPp+p) were:
Danish: De alvorlige bivirkninger, der hyppigere blev observeret (≥ 5 %) med melphalan, prednison og lenalidomid, efterfulgt af vedligeholdelse med lenalidomid (MPR+R) eller melphalan, prednison og lenalidomid, efterfulgt af placebo (MPR+p) end med melphalan, prednison og placebo, efterfulgt af placebo (MPp+p), var:
English: If lenalidomide makes contact with the mucous membranes, they should be thoroughly flushed with water.
Danish: Hvis lenalidomid får kontakt med slimhinder, skal de skylles grundigt med vand.
English: Arrhythmia, QT prolongation, Atrial flutter, Ventricular extrasystoles
Danish: Ikke almindelig Arytmi, forlænget QT-interval, atrieflagren, ventrikulære ekstrasystoler
English: The median duration of treatment was 44.0 weeks (min: 0.1, max: 254.9) for len/dex and 23.1 weeks (min: 0.3, max: 238.1) for placebo/dex.
Danish: Den mediane behandlingsvarighed var 44,0 uger (min: 0,1; max: 254,9) for len/dex og 23,1 uger (min: 0,3; max: 238,1) for placebo/dex.
English: Co-administration of multiple doses of the strong P-gp inhibitor quinidine (600 mg, twice daily) or the moderate P-gp inhibitor/substrate temsirolimus (25 mg) has no clinically relevant effect on the pharmacokinetics of lenalidomide (25 mg).
Danish: Samtidig administration af flere doser af den potente P-gp-hæmmer quinidin (600 mg, to gange dagligt) eller den moderate Pgp-hæmmer/substrat temsirolimus (25 mg) har ingen klinisk relevant virkning på lenalidomids farmakokinetik (25 mg).
English: • Pregnancy test regime o Before commencing treatment o During treatment, every 4 weeks except in case of confirmed tubal sterilisation o After finishing treatment
Danish: • Graviditetstest-regime o Før behandlingen påbegyndes o Hver 4. uge under behandlingen undtagen ved bekræftet tubal sterilisation o Efter behandlingens afslutning
English: • The active substance is lenalidomide.
Danish: • Aktivt stof: lenalidomid.
English: These patients should be monitored closely, especially during the first cycle or dose-escalation, and appropriate precautions taken.
Danish: Der skal udvises forsigtighed, når lenalidomidbehandling initieres hos disse patienter, og patienterne skal monitoreres nøje, især i løbet af første cyklus og ved dosisøgning, og der skal tages passende forholdsregler.
English: If you think you may be allergic, ask your doctor for advice.
Danish: Spørg lægen om råd, hvis du mener, du kan være allergisk.
English: It is recommended to press only on one end of the capsule to remove it from the blister thereby reducing the risk of capsule deformation or breakage.
Danish: Det anbefales kun at trykke på den ene ende af kapslen for at få den ud af blisteren.
English: If pregnancy occurs in a woman treated with lenalidomide, treatment must be stopped and the patient should be referred to a physician specialised or experienced in teratology for evaluation and advice.
Danish: Hvis en kvinde, som er i behandling med lenalidomid, bliver gravid, skal behandlingen ophøre, og patienten skal henvises til en læge med speciale eller erfaring i teratologi til vurdering og rådgivning.
English: Interrupt lenalidomide treatment
Danish: Afbryd behandlingen med lenalidomid
English: Very Common Rash, Dry skin
Danish: Meget almindelig Udslæt, tør hud
English: Hypomagnesaemia, Hyperuricaemia, Dehydration◊, Hypercalcaemia+
Danish: Hypomagnesiæmi, hyperurikæmi, dehydrering◊, hyperkalcæmi+
English: Prednisone
Danish: Prednison
English: Tabulated summary for monotherapy in MM
Danish: Oversigt i tabelform for monoterapi ved MM
English: Grade 3 or 4 thrombocytopenia was observed to a lesser extent in the Rd and Rd18 arms than in the comparator arm (8.1% vs 11.1%, respectively).
Danish: Grad 3 eller 4 trombocytopeni blev observeret i mindre grad i Rd- og Rd18-armene, i forhold til den sammenlignende arm (hhv. 8,1 % vs. 11,1 %).
English: Grade 4 febrile neutropenia was observed infrequently (0.6% in Rd and Rd18 compared with 0.7% in MPT).
Danish: Grad 4 febril neutropeni blev ikke observeret hyppigt (0,6 % med RD og Rd18 sammenlignet med 0,7 % med MPT).
English: The maintenance dose was 10 mg once daily on days 1-28 of repeated 28-day cycles (increased up to 15 mg once daily after 3 months in the absence of dose-limiting toxicity), and treatment was continued until disease progression.
Danish: Vedligeholdelsesdosis var 10 mg én gang dagligt dag 1-28 i gentagne cyklusser af 28 dage (øget til højst 15 mg én gang dagligt efter 3 måneder i fravær af dosisbegrænsende toksicitet), og behandlingen blev fortsat indtil sygdomsprogression.
English: • Fever and flu like symptoms including fever, muscle ache, headache, ear ache and chills
Danish: • Feber og influenzalignende symptomer, herunder feber, muskelsmerter, hovedpine, ørepine og kulderystelser
English: The capsules should not be opened, broken or chewed.
Danish: Kapslerne må ikke åbnes, knuses eller tygges.
English: ◊ Adverse reactions reported as serious in clinical trials in patients with NDMM who had undergone ASCT * Applies to serious adverse drug reactions only ^ See section 4.8 description of selected adverse reactions a “Pneumonias” combined AE term includes the following PTs: Bronchopneumonia, Lobar pneumonia, Pneumocystis jiroveci pneumonia, Pneumonia, Pneumonia klebsiella, Pneumonia legionella, Pneumonia mycoplasmal, Pneumonia pneumococcal, Pneumonia streptococcal, Pneumonia viral, Lung disorder, Pneumonitis b “Sepsis” combined AE term includes the following PTs: Bacterial sepsis, Pneumococcal sepsis, Septic shock, Staphylococcal sepsis c “Peripheral neuropathy” combined AE term includes the following preferred terms (PTs): Neuropathy peripheral, Peripheral sensory neuropathy, Polyneuropathy d “Deep vein thrombosis” combined AE term includes the following PTs: Deep vein thrombosis, Thrombosis, Venous thrombosis
Danish: 4.8 Beskrivelse af udvalgte bivirkninger a ”Pneumoni” kombineret bivirkningsterm, der inkluderer følgende foretrukne termer: Bronkopneumoni, lobær pneumoni, Pneumocystis jiroveci-pneumoni, pneumoni, Klebsiella-pneumoni, Legionella-pneumoni, Mycoplasma-pneumoni, pneumokok-pneumoni, streptokokpneumoni, viral pneumoni, lungeforstyrrelse, pneumonitis b “Sepsis” kombineret bivirkningsterm, der inkluderer følgende foretrukne termer: Bakteriel sepsis, pneumokok-sepsis, sepsis, septisk shock, stafylokok-sepsis c “Perifer neuropati” kombineret bivirkningsterm, der inkluderer følgende foretrukne termer: Perifer neuropati, perifer sensorisk neuropati, polyneuropati d “Dyb venetrombose” kombineret bivirkningsterm, der inkluderer følgende foretrukne termer: Dyb venetrombose, trombose, venøs trombose
English: Concomitant administration of erythropoietic agents or previous history of thromboembolic events may also increase thrombotic risk in these patients.
Danish: Samtidig administration af erytropoietiner eller tromboemboliske hændelser i anamnesen kan også øge risikoen for trombose hos disse patienter.
English: Lenalidomide Accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.
Danish: Lenalidomide Accord som monoterapi er indiceret til vedligeholdelsesbehandling af nyligt diagnosticeret myelomatose hos voksne patienter, der har gennemgået autolog stamcelletransplantation.
English: Lenalidomide Accord in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.
Danish: Lenalidomide Accord i kombination med dexamethason er indiceret til behandling af voksne patienter med myelomatose, som allerede har fået mindst én behandling.
English: Endocrine Disorders
Danish: Det endokrine system
English: • Educational brochures for Patients
Danish: • Informationsbrochurer til patienter