FrancophonIA/ELRC3.0 huggingface dataset:
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 30 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PERFORERET BLISTER til 30 mg
English: GIOTRIF 20 mg film-coated tablets afatinib
Danish: Giotrif 20 mg filmovertrukne tabletter afatinib
English: NAME OF THE MEDICINAL PRODUCT GIOTRIF 20 mg tablets afatinib
Danish: LÆGEMIDLETS NAVN Giotrif 20 mg tabletter afatinib
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 50 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PERFORERET BLISTER til 50 mg
English: 6.9 vs. 3.4 HR 0.70; p=0.0220 values presented for GIOTRIF vs. chemotherapy, p-value based on logistic regression b p-value for time to deterioration based on stratified log-rank test
Danish: værdier vist for Giotrif vs. kemoterapi, p-værdi baseret på logistisk regression b p-værdier for tiden indtil forværring baseret på stratificeret log-rank test
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 40 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PERFORERET BLISTER til 40 mg
English: Light blue, round, biconvex and bevel-edged film-coated tablet debossed with the code “T40” on one side and the Boehringer Ingelheim company logo on the other.
Danish: Lyseblå, rund, bikonveks og skråt afskåret filmovertrukket tablet præget med koden “T40” på den ene side og Boehringer Ingelheims firmalogo på den anden side.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 20 mg afatinib (as dimaleate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 20 mg afatinib (som dimaleat).
English: Each film-coated tablet contains 50 mg of afatinib (as dimaleate).
Danish: Hver filmovertrukket tablet indeholder 50 mg afatinib (som dimaleat).
English: GIOTRIF 50 mg film-coated tablets
Danish: Giotrif 50 mg filmovertrukne tabletter
English: Each film-coated tablet contains 40 mg of afatinib (as dimaleate).
Danish: Hver filmovertrukket tablet indeholder 40 mg afatinib (som dimaleat).
English: Each film-coated tablet contains 30 mg of afatinib (as dimaleate).
Danish: Hver filmovertrukket tablet indeholder 30 mg afatinib (som dimaleat).
English: NAME OF THE MEDICINAL PRODUCT GIOTRIF 50 mg tablets afatinib
Danish: LÆGEMIDLETS NAVN Giotrif 50 mg tabletter afatinib
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/010
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/879/010
English: GIOTRIF 30 mg film-coated tablets EU/1/13/879/004
Danish: Giotrif 30 mg filmovertrukne tabletter EU/1/13/879/004
English: GIOTRIF 20 mg film-coated tablets EU/1/13/879/001
Danish: Giotrif 20 mg filmovertrukne tabletter EU/1/13/879/001
English: GIOTRIF 30 mg film-coated tablets afatinib
Danish: Giotrif 30 mg filmovertrukne tabletter afatinib
English: GIOTRIF 40 mg film-coated tablets afatinib
Danish: Giotrif 40 mg filmovertrukne tabletter afatinib
English: NAME OF THE MEDICINAL PRODUCT GIOTRIF 40 mg tablets afatinib
Danish: LÆGEMIDLETS NAVN Giotrif 40 mg tabletter afatinib
English: NAME OF THE MEDICINAL PRODUCT GIOTRIF 30 mg tablets afatinib
Danish: LÆGEMIDLETS NAVN Giotrif 30 mg tabletter afatinib
English: They are debossed with the code “T20” on one side and the Boehringer Ingelheim company logo on the other.
Danish: De er præget med koden “T20” på den ene side og Boehringer Ingelheim firmalogo på den anden side.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 30 mg)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON (FOLDEÆSKE TIL BLISTER til 30 mg)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 40 mg)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON (FOLDEÆSKE TIL BLISTER til 40 mg)
English: NAME OF THE MEDICINAL PRODUCT GIOTRIF 20 mg film-coated tablets afatinib
Danish: LÆGEMIDLETS NAVN Giotrif 20 mg filmovertrukne tabletter afatinib
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg afatinib (as dimaleate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 30 mg afatinib (som dimaleat).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 50 mg)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON (FOLDEÆSKE TIL BLISTER til 50 mg)
English: GIOTRIF 40 mg film-coated tablets EU/1/13/879/007
Danish: Giotrif 40 mg filmovertrukne tabletter EU/1/13/879/007
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 40 mg afatinib (as dimaleate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 40 mg afatinib (som dimaleat).
English: They are debossed with the code “T30” on one side and the Boehringer Ingelheim company logo on the other.
Danish: De er præget med koden “T30” på den ene side og Boehringer Ingelheim firmalogo på den anden side.
English: Tell your doctor if you have sudden or worsening of eye symptoms such as pain or redness or dry eye.
Danish: Hvis du pludselig får symptomer fra øjnene, som f.eks. smerter, røde eller tørre øjne, eller hvis sådanne symptomer bliver værre, skal du fortælle det til lægen.
English: GIOTRIF 50 mg film-coated tablets afatinib
Danish: Giotrif 50 mg filmovertrukne tabletter afatinib
English: They are debossed with the code “T50” on one side and the Boehringer Ingelheim company logo on the other.
Danish: De er præget med koden “T50” på den ene side og Boehringer Ingelheim firmalogo på den anden side.
English: NAME OF THE MEDICINAL PRODUCT GIOTRIF 40 mg film-coated tablets afatinib
Danish: LÆGEMIDLETS NAVN Giotrif 40 mg filmovertrukne tabletter afatinib
English: Epistaxis
Danish: Dosisøgning
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIOTRIF 20 mg film-coated tablets afatinib
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Giotrif 20 mg filmovertrukne tabletter afatinib
English: NAME OF THE MEDICINAL PRODUCT GIOTRIF 30 mg film-coated tablets afatinib
Danish: LÆGEMIDLETS NAVN Giotrif 30 mg filmovertrukne tabletter afatinib
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 50 mg afatinib (as dimaleate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 50 mg afatinib (som dimaleat).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIOTRIF 30 mg film-coated tablets afatinib
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Giotrif 30 mg filmovertrukne tabletter afatinib
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/879/004
English: NAME OF THE MEDICINAL PRODUCT GIOTRIF 50 mg film-coated tablets afatinib
Danish: LÆGEMIDLETS NAVN Giotrif 50 mg filmovertrukne tabletter afatinib
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/879/001
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIOTRIF 40 mg film-coated tablets afatinib
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Giotrif 40 mg filmovertrukne tabletter afatinib
English: • Runny nose
Danish: Næseblod Rinoré
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIOTRIF 50 mg film-coated tablets afatinib
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Giotrif 50 mg filmovertrukne tabletter afatinib
English: They are debossed with the code “T40” on one side and the Boehringer Ingelheim company logo on the other.
Danish: De er præget med koden “T40” på den ene side og Boehringer Ingelheim firmalogo på den anden side.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/007
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/879/007
English: Interactions with Cytochrome P450 (CYP) enzymes
Danish: Interaktioner med CYP-enzymer
English: If you take more GIOTRIF than you should
Danish: Hvis du har taget for meget Giotrif
English: a Adverse reactions
Danish: Undersøgelser Vægttab
English: • Muscle spasms
Danish: • Muskelkramper
English: MA (EU)Number
Danish: MF (EU)-nummer
English: 30th January 2020
Danish: 30. januar 2020
English: For any of the following:
Danish: Ved enhver af følgende:
English: Your doctor will decide how many treatments you need.
Danish: Lægen vil bestemme, hvor mange behandlinger, du har brug for.
English: Events (%)
Danish: Hændelser (%)
English: • you have had an organ transplant.
Danish: • du har fået en organtransplantation.
English: These reactions are presented by system organ class and frequency.
Danish: Disse reaktioner vises pr. systemorganklasse og hyppighed.
English: Do not try to treat yourself with other medicines.
Danish: Du må ikke forsøge at behandle dig selv med andre lægemidler.
English: Improvement of PFS was observed across pre-specified subgroups.
Danish: Der blev observeret en forbedring af PFS i alle præspecificerede undergrupper.
English: • give you other medicines in order to prevent complications and reduce your symptoms,
Danish: • give dig andre lægemidler, for at undgå komplikationer og reducere dine symptomer,
English: If you suffer from any of these you should seek urgent medical attention:
Danish: Hvis du lider af nogle af disse, skal du søge akut lægehjælp:
English: Bavencio can cause harm to your unborn baby.
Danish: Bavencio kan forårsage skader på dit ufødte barn.
English: Date of first authorisation: 18 September 2017 Date of latest renewal: 20 June 2019
Danish: Dato for første markedsføringstilladelse: 18. september 2017 Dato for seneste fornyelse: 20. juni 2019
English: Total systemic clearance increases with body weight.
Danish: Den totale systemisk clearance stiger med legemsvægten.
English: * 1-sided p-value based on stratified log-rank.
Danish: * 1-sidet p-værdi baseret på stratificeret log-rank.
English: Bavencio is used in adults to treat:
Danish: Bavencio anvendes hos voksne til at behandle:
English: Blood tests and weight checks:
Danish: Blodprøver og vægtkontroller:
English: Treatment should be initiated and supervised by a physician experienced in the treatment of cancer.
Danish: Behandlingen skal påbegyndes og overvåges af en læge med erfaring i behandling af cancer.
English: Confirmed best overall response (BOR)
Danish: Bekræftet bedste samlede respons (BOR)
English: The treatment is directed to the management of symptoms.
Danish: Behandlingen rettes mod håndtering af symptomerne.
English: Patients excluded from clinical studies
Danish: Patienter, der blev ekskluderet fra kliniske studier
English: Since it is known that antibodies can be secreted in human milk, a risk to the newborns/infants cannot be excluded.
Danish: Da det er kendt, at antistoffer kan udskilles i human mælk, kan en risiko for nyfødte/spædbørn ikke udelukkes.
English: Some side effects may happen weeks or months after your last dose.
Danish: Nogle bivirkninger kan opstå uger eller måneder efter din sidste dosis.
English: (18, not estimable)
Danish: (18, kan ikke estimeres)
English: The volume of distribution at steady state was 4.72 L.
Danish: Fordelingsvolumen ved steady-state er 4,72 l.
English: Time to response (TTR)
Danish: Tid til respons (TTR)
English: Dose escalation or reduction is not recommended.
Danish: Dosisoptrapning eller -reduktion anbefales ikke.
English: This being a conditional marketing authorisation and pursuant to Article 14a(4) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Danish: Dette er en betinget markedsføringstilladelse, og i henhold til artikel 14-a, stk. 4, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: Please note that in some cases symptoms may be delayed, and may develop after your last dose.
Danish: Bemærk, at disse symptomer i nogle tilfælde er forsinkede, og kan opstå efter din sidste dosis.
English: You will receive Bavencio in a hospital or clinic, under the supervision of an experienced doctor.
Danish: Du vil få Bavencio på et hospital eller en klinik, overvåget af en erfaren læge.
English: • you have an autoimmune disease (a condition where the body attacks its own cells);
Danish: • du har en autoimmun sygdom (en tilstand, hvor kroppen angriber sine egne celler),
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler skal det administrerede produkts handelsnavn og batchnummer tydeligt registreres.
English: • Brief introduction to the tool and its purpose
Danish: • Kort introduktion i værktøjet og dets formål
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: Unopened vial 2 years
Danish: Uåbnet hætteglas 2 år
English: Your doctor will check your general health before and during treatment with Bavencio.
Danish: Lægen vil kontrollere dit generelle helbred før og under behandlingen med Bavencio.
English: Depending on how your body responds to treatment, your doctor may decide to continue giving you these medicines before all of your Bavencio treatments.
Danish: Afhængigt af, hvordan din krop reagerer på behandlingen, kan din læge beslutte sig for at fortsætte med at give dig disse lægemidler, før alle dine behandlinger med Bavencio.
English: Stopping your treatment may stop the effect of the medicine.
Danish: Hvis du holder op med behandlingen, kan det stoppe lægemidlets virkning.
English: A risk to the breast-fed child cannot be excluded.
Danish: En risiko for det ammede barn kan ikke udelukkes.
English: The efficacy endpoints were based on 29 patients with 13 weeks of follow-up.
Danish: Effektendepunkterne var baseret på 29 patienter med 13 ugers opfølgning.
English: You will have blood tests during your treatment and your doctor will monitor your weight before and during treatment.
Danish: Du vil få foretaget blodprøver under behandlingen, og lægen vil overvåge din vægt før og under behandlingen.
English: Seek urgent medical attention if you experience inflammation in any part of your body or if you have any of the following signs or symptoms, or if they get worse.
Danish: Søg akut lægehjælp, hvis du oplever betændelse et hvilket som helst sted i kroppen, eller hvis du har de følgende tegn eller symptomer, eller hvis de forværres.
English: Randomization was stratified according to Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (0 vs. 1) and region (United States vs. Canada/Western Europe vs. the rest of the world).
Danish: Randomiseringen blev stratificeret i henhold til Eastern Cooperative Oncology Group (ECOG) performance status (PS) (0 vs. 1) og region (USA vs. Canada/Vesteuropa vs. resten af verden).
English: With a median OS follow-up of 19 months, OS data were immature with 27% deaths.
Danish: Med en median OS opfølgning på 19 måneder var OS-data umodne med 27 % dødsfald.
English: Suspected pneumonitis should be confirmed with radiographic imaging.
Danish: Formodet pneumonitis skal bekræftes radiografisk billeddannelse.
English: Succursale de Corsier-sur-Vevey Chemin du Fenil - Zone Industrielle B 1804 Corsier-sur-Vevey Switzerland
Danish: Succursale de Corsier-sur-Vevey Chemin du Fenil - Zone Industrielle B 1804 Corsier-sur-Vevey Schweiz
English: Duration of response (DOR)a
Danish: Varighed af respons (DOR)a
English: Bavencio has not been studied in children and adolescents below 18 years of age.
Danish: Bavencio er ikke blevet undersøgt hos børn og unge under 18 år.
English: • Brief introduction to avelumab (indication and purpose of this tool)
Danish: • Kort introduktion til avelumab (indikation og formål med redskabet)
English: If you miss an appointment, ask your doctor when to schedule your next dose.
Danish: Hvis du glemmer en aftale, skal du spørge lægen om, hvornår din næste dosis skal planlægges.
English: A new ADA method with improved sensitivity and drug tolerance was used in the RCC population.
Danish: En ny ADA-metode med forbedret følsomhed og lægemiddeltolerans blev anvendt i RCC-populationen.
English: • you receive medicines to suppress your immune system;
Danish: • du får lægemidler, der undertrykker dit immunsystem,
English: * Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4.03)
Danish: * Toksiciteten var klassificeret i henhold til National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4.03)
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Danish: Hvis den fortyndede opløsning ikke anvendes straks, er opbevaringstid og betingelser før brug brugerens ansvar.
English: BICR: Blinded Independent Central Review; CI: Confidence interval; NE: Not estimable.
Danish: BICR: Blindet uafhængig central bedømmelse, CI: Konfidensinterval, NE: Kan ikke estimeres.
English: The majority (n=160, 71.4%) of the patients with progressive disease continued treatment with both medicinal products after progression.
Danish: Størstedelen (n = 160, 71,4 %) af patienterne med progressiv sygdom fortsatte behandlingen med begge lægemidler efter progression.
English: Patients were randomised (1:1) to one of the following treatment arms:
Danish: Patienterne blev randomiseret (1:1) til en af de følgende behandlingsarme:
English: • The solution should be inspected to ensure it is clear, colourless, and free of visible particles.
Danish: • Opløsningen skal inspiceres for at sikre, at den er klar, farveløs og fri for synlige partikler.
English: Based on data available, including the low incidence of immunogenicity, the impact of ADA on pharmacokinetics, efficacy and safety is uncertain, while the impact of neutralizing antibodies (nAb) is unknown.
Danish: Baseret på de tilgængelige data, herunder den lave forekomst af immunogenicitet, er påvirkningen af ADA på farmakokinetik, virkning og sikkerhed usikker, mens påvirkningen af neutraliserende antistoffer (nAb) er ukendt.
English: It must not be administered as an intravenous push or bolus injection.
Danish: Det må ikke administreres som intravenøs støddosis eller bolus injektion.
English: Avelumab is expected to be distributed in the systemic circulation and to a lesser extent in the extracellular space.
Danish: Avelumab forventes at blive fordelt i det systemiske kredsløb, og i mindre grad i det ekstracellulære rum.
English: Based on a population pharmacokinetic analysis from 1,629 patients, the value of total systemic clearance (CL) is 0.59 L/day.
Danish: Baseret på en populationsfarmakokinetisk analyse af 1.629 patienter, er værdien af den totale systemiske clearance (CL) 0,59 l/dag.
English: • Inflammatory reaction of the whole body (Systemic inflammatory response syndrome)
Danish: • Betændelsesreaktion i hele kroppen (systemisk inflammatorisk responssyndrom)
English: • Requirement for 10 mg per day or greater prednisone or equivalent for more than 12 weeks
Danish: • Behov for 10 mg dagligt eller derover af prednison eller tilsvarende i over 12 uger
English: Efficacy results are presented in Table 7 and Figure 3 based on a data cut-off date of 28 January 2019.
Danish: Virkningsresultaterne er vist i tabel 7 og figur 3 baseret på tidspunktet for data cut-off den 28. januar 2019.
English: The diluted solution should be used immediately once prepared.
Danish: Den fortyndede opløsning skal anvendes umiddelbart efter forberedelse.
English: Bavencio is for intravenous infusion only.
Danish: Bavencio er kun til intravenøs infusion.
English: Patients should be advised to use caution when driving or operating machinery until they are certain that avelumab does not adversely affect them.
Danish: Patienter skal rådes til at udvise forsigtighed, når de fører motorkøretøj eller betjener maskiner, indtil de er sikre på, at avelumab ikke påvirker dem negativt.
English: As expected for an antibody, avelumab does not bind to plasma proteins in a specific manner.
Danish: Som forventet for et antistof, bindes avelumab ikke til plasmaproteiner på en specifik måde.
English: • Reminder of the importance to consult their doctor before any change of treatment or in case of side effect
Danish: • En påmindelse om vigtigheden af at kontakte lægen, før behandlingen ændres eller i tilfælde af bivirkninger
English: After preparation of infusion
Danish: Efter forberedelse af infusionen
English: PD-L1 status was determined by immunohistochemistry.
Danish: PD-L1-status blev bestemt ved immunhistokemi.
English: (10.2, not estimable)
Danish: (10,2; kan ikke estimeres)
English: You must not use Bavencio if you are pregnant unless your doctor specifically recommends it.
Danish: Du må ikke bruge Bavencio hvis du er gravid, medmindre lægen specifikt anbefaler det.
English: Administration of Bavencio should continue according to the recommended schedule until disease progression or unacceptable toxicity.
Danish: Administration af Bavencio skal fortsætte i henhold til den anbefalede dosering, indtil sygdomsprogression eller uacceptabel toksicitet.
English: • you have ever had chronic viral infection of the liver, including hepatitis B (HBV) or hepatitis C
Danish: • du nogensinde har haft en kronisk virusinfektion i leveren, herunder hepatitis B (HBV) eller hepatitis C (HCV),
English: Consistent with a limited extravascular distribution, the volume of distribution of avelumab at steady state is small.
Danish: I overensstemmelse med begrænset ekstravaskulær fordeling, er fordelingsvolumen for avelumab ved steady-state lille.
English: You will receive Bavencio as an infusion (a drip) into a vein (intravenously) over a period of 1 hour.
Danish: Du vil få Bavencio som en infusion (et drop) i en vene (intravenøst) over en periode på 1 time.
English: ** CIs are derived using the log-log transformation with back transformation to untransformed scale.
Danish: ** CI'er er afledt af log-log-transformation med transformation tilbage til ikke-transformeret skala.
English: Progression-free survival (PFS)
Danish: Progressionsfri overlevelse (PFS)
English: IHC-MCV tumour status
Danish: IHC-MCV tumorstatus
English: • Brief introduction to Bavencio treatment
Danish: • Kort introduktion til behandlingen med Bavencio
English: The pack size is 1 glass vial per carton.
Danish: Pakningsstørrelsen er 1 hætteglas pr. karton.
English: For Bavencio in combination with axitinib, see below.
Danish: For Bavencio i kombination med axitinib, se nedenfor.
English: All 5 patients with Type 1 diabetes mellitus were treated with insulin.
Danish: Alle 5 patienter med type 1 diabetes mellitus blev behandlet med insulin.
English: Patients with radiological disease progression not associated with significant clinical deterioration, defined as no new or worsening symptoms, no change in performance status for greater than two weeks, and no need for salvage therapy could continue treatment.
Danish: Patienter med radiologisk sygdomsprogression, som ikke er forbundet med en signifikant klinisk forværring, defineret som ingen nye eller forværrede symptomer, ingen ændring i præstationsstatus i over 2 uger, og intet behov for salvage behandling, kunne fortsætte behandlingen.
English: No studies have been conducted to assess the potential of avelumab for carcinogenicity or genotoxicity.
Danish: Der er ikke udført studier for at vurdere avelumabs potentiale for carcinogent potentiale eller genotoksicitet.
English: Fertility The effect of avelumab on male and female fertility is unknown.
Danish: Fertilitet Virkningen af avelumab på fertiliteten hos mænd og kvinder er ukendt.
English: Pregnancy There are no or limited data from the use of avelumab in pregnant women.
Danish: Graviditet Der er ingen eller utilstrækkelige data fra anvendelse af avelumab til gravide kvinder.