FrancophonIA/ELRC3.0 huggingface dataset:
English: Jentadueto is not recommended in patients with hepatic impairment due to the active substance metformin (see sections 4.3 and 5.2).
Danish: På grund af det aktive stof metformin anbefales Jentadueto ikke til patienter med nedsat leverfunktion (se pkt.
English: Jentadueto 2.5 mg/850 mg film-coated tablets EU/1/12/780/001 (10 x 1 film-coated tablets) EU/1/12/780/002 (14 x 1 film-coated tablets) EU/1/12/780/003 (28 x 1 film-coated tablets) EU/1/12/780/004 (30 x 1 film-coated tablets) EU/1/12/780/005 (56 x 1 film-coated tablets) EU/1/12/780/006 (60 x 1 film-coated tablets) EU/1/12/780/007 (84 x 1 film-coated tablets) EU/1/12/780/008 (90 x 1 film-coated tablets) EU/1/12/780/009 (98 x 1 film-coated tablets) EU/1/12/780/010 (100 x 1 film-coated tablets) EU/1/12/780/011 (120 x 1 film-coated tablets) EU/1/12/780/012 (14 film-coated tablets, bottle) EU/1/12/780/013 (60 film-coated tablets, bottle) EU/1/12/780/014 (180 film-coated tablets, bottle) EU/1/12/780/029 (120 (2 x 60 x 1) film-coated tablets) EU/1/12/780/030 (180 (2 x 90 x 1) film-coated tablets) EU/1/12/780/031 (200 (2 x 100 x 1) film-coated tablets)
Danish: Jentadueto 2,5 mg/850 mg filmovertrukne tabletter EU/1/12/780/001 (10 x 1 filmovertrukne tabletter) EU/1/12/780/002 (14 x 1 filmovertrukne tabletter) EU/1/12/780/003 (28 x 1 filmovertrukne tabletter) EU/1/12/780/004 (30 x 1 filmovertrukne tabletter) EU/1/12/780/005 (56 x 1 filmovertrukne tabletter) EU/1/12/780/006 (60 x 1 filmovertrukne tabletter) EU/1/12/780/007 (84 x 1 filmovertrukne tabletter) EU/1/12/780/008 (90 x 1 filmovertrukne tabletter) EU/1/12/780/009 (98 x 1 filmovertrukne tabletter) EU/1/12/780/010 (100 x 1 filmovertrukne tabletter) EU/1/12/780/011 (120 x 1 filmovertrukne tabletter) EU/1/12/780/012 (14 filmovertrukne tabletter, beholder) EU/1/12/780/013 (60 filmovertrukne tabletter, beholder) EU/1/12/780/014 (180 filmovertrukne tabletter, beholder) EU/1/12/780/029 (120 (2 x 60 x 1) filmovertrukne tabletter) EU/1/12/780/030 (180 (2 x 90 x 1) filmovertrukne tabletter) EU/1/12/780/031 (200 (2 x 100 x 1) filmovertrukne tabletter)
English: EU/1/12/780/015 10 x 1 film-coated tablets EU/1/12/780/016 14 x 1 film-coated tablets EU/1/12/780/017 28 x 1 film-coated tablets EU/1/12/780/018 30 x 1 film-coated tablets EU/1/12/780/019 56 x 1 film-coated tablets EU/1/12/780/020 60 x 1 film-coated tablets EU/1/12/780/021 84 x 1 film-coated tablets EU/1/12/780/022 90 x 1 film-coated tablets EU/1/12/780/023 98 x 1 film-coated tablets EU/1/12/780/024 100 x 1 film-coated tablets EU/1/12/780/025 120 x 1 film-coated tablets
Danish: EU/1/12/780/015 10 x 1 filmovertrukne tabletter EU/1/12/780/016 14 x 1 filmovertrukne tabletter EU/1/12/780/017 28 x 1 filmovertrukne tabletter EU/1/12/780/018 30 x 1 filmovertrukne tabletter EU/1/12/780/019 56 x 1 filmovertrukne tabletter EU/1/12/780/020 60 x 1 filmovertrukne tabletter EU/1/12/780/021 84 x 1 filmovertrukne tabletter EU/1/12/780/022 90 x 1 filmovertrukne tabletter EU/1/12/780/023 98 x 1 filmovertrukne tabletter EU/1/12/780/024 100 x 1 filmovertrukne tabletter EU/1/12/780/025 120 x 1 filmovertrukne tabletter
English: (pancreatitis).
Danish: (se pkt.
English: Constipation uncommon
Danish: Forstoppelse ikke almindelig
English: if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
Danish: Tag ikke Jentadueto: - hvis du er allergisk over for linagliptin eller metformin eller et af de øvrige indholdsstoffer i Jentadueto (angivet i afsnit 6) - hvis du har alvorligt nedsat nyrefunktion - hvis du har sukkersyge (diabetes), der ikke er under kontrol, f.eks. med for højt blodsukker (alvorlig hyperglykæmi), kvalme, opkastning, diarré, hurtigt vægttab, laktatacidose (se ”Risiko for laktatacidose” nedenfor) eller ketoacidose.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Danish: BILAG II A. FREMSTILLER(E) ANSVARLIGE FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Posology
Danish: Laktatacidose
English: with a mean treatment difference of 0.20% (97.5% CI: 0.09, 0.299).
Danish: tillægs-placebo -0,47 % (95 %-CI: -0,66; -0,28)).
English: Body mass index had no clinically relevant effect on the pharmacokinetics of linagliptin based on a population pharmacokinetic analysis of Phase I and Phase II data.
Danish: Baseret på en farmakokinetisk populationsanalyse af fase I- og fase II-data, havde BMI ikke nogen klinisk relevant indvirkning på linagliptins farmakokinetik.
English: feeling sick (nausea) - Uncommon: inflamed nose or throat (nasopharyngitis), cough, loss of appetite (decreased appetite), being sick (vomiting), blood enzyme increase (amylase increase), itching (pruritus) - Rare: blistering of skin (bullous pemphigoid)
Danish: opkastning, stigning i blodenzymer (forhøjet amylase), kløe (pruritus).
English: The efficacy and safety of linagliptin in combination with metformin in patients with insufficient glycaemic control on metformin monotherapy was evaluated in a double-blind placebo-controlled study of 24 weeks duration.
Danish: Et 24-ugers dobbeltblindet placebokontrolleret studie undersøgte effekt og sikkerhed af linagliptin i kombination med metformin hos patienter i metformin-monoterapi med utilstrækkelig glykæmisk kontrol.
English: Race
Danish: Køn
English: These may be used to control fits (seizures) or chronic pain.
Danish: da det kan være et tegn på betændelse i bugspytkirtlen (pankreatitis).
English: Linagliptin 24 month data, as add-on to metformin in comparison with glimepiride In a study comparing the efficacy and safety of the addition of linagliptin 5 mg or glimepiride (mean dose 3 mg) in patients with inadequate glycaemic control on metformin monotherapy, mean reductions in HbA1c were -0.16% with linagliptin (mean baseline HbA1c 7.69%) and -0.36% with glimepiride (mean baseline HbA1c 7.69%.)
Danish: 24 måneders data for linagliptin som supplement til metformin, sammenlignet med glimepirid Et studie med patienter i metformin-monoterapi uden tilstrækkelig glykæmisk kontrol undersøgte effekt og sikkerhed ved supplement af enten linagliptin 5 mg eller glimepirid (gennemsnitlig dosis 3 mg).
English: Package size
Danish: Paknings-størrelse
English: Invented name Strength Pharmaceutical Form Route of Administration Packaging
Danish: Lægemiddelform Indgivelsesvej
English: 14 October 2016 EMA/610687/2016 EMEA/H/C/004080
Danish: 14. oktober 2016 EMA/610687/2016 EMEA/H/C/004080
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal of the application is based on commercial reasons following an evaluation of the current market situation.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at tilbagetrækningen af ansøgningen skyldtes forretningsmæssige grunde, der var baseret på en vurdering af den aktuelle markedssituation.
English: The company had not yet responded to the questions at the time of the withdrawal.
Danish: Virksomheden havde endnu ikke besvaret spørgsmålene, da ansøgningen blev trukket tilbage.
English: The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Danish: Ansøgningen blev trukket tilbage, efter at CHMP havde vurderet den dokumentation, virksomheden oprindelig havde fremlagt, og udarbejdet en liste med spørgsmål.
English: Ertapenem Hospira was expected to be used in adults and children aged over 3 months to treat the following infections, if caused by bacteria likely to be killed by ertapenem:
Danish: Ertapenem Hospira forventedes anvendt hos voksne og børn over 3 måneder til behandling af følgende infektioner, hvis de var forårsaget af bakterier, som ertapenem forventedes at dræbe:
English: On 13 September 2016, Hospira UK Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ertapenem Hospira, for the treatment of certain infections and for the prevention of infection in colorectal surgery.
Danish: Den 13. september 2016 meddelte Hospira UK Limited officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om markedsføringstilladelse for Ertapenem Hospira til behandling af visse infektioner og til forebyggelse af infektion ved kolorektale operationer.
English: Ertapenem attaches to certain proteins on the surface of the bacteria cells.
Danish: Ertapenem bindes til visse proteiner på overfladen af bakteriecellerne.
English: The CHMP had concerns about the choice of the starting materials for making the active substance, the process used to manufacture the medicine, the method for testing the purity of the medicine and the medicine's shelf life.
Danish: CHMP havde betænkeligheder ved valget af udgangsmaterialer til fremstilling af det aktive stof, den anvendte fremstillingsproces for lægemidlet, metoden til test af renheden af lægemidlet og lægemidlets holdbarhed.
English: Because Ertapenem Hospira was developed as a generic medicine, the company presented the results of studies to show the quality of the medicine.
Danish: Da Ertapenem Hospira er udviklet som et generisk lægemiddel, fremlagde virksomheden resultaterne af undersøgelser til dokumentation af lægemidlets kvalitet.
English: What was Ertapenem Hospira expected to be used for?
Danish: Hvad forventedes Ertapenem Hospira anvendt til?
English: This upsets the essential functions that keep the cells alive, and kills the bacteria.
Danish: Dette forstyrrer bakteriernes livsvigtige funktioner, så de dør.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Ertapenem Hospira could not have been approved for the treatment of infections and for the prevention of infection in colorectal surgery.
Danish: På baggrund af gennemgangen af dataene havde CHMP på tidspunktet for tilbagetrækningen af ansøgningen visse betænkeligheder og var af den foreløbige opfattelse, at Ertapenem Hospira ikke kunne være blevet godkendt til behandling af infektioner og til forebyggelse af infektioner ved kolorektale operationer.
English: This means that Ertapenem Hospira was intended to be similar to a ‘reference medicine' already authorised in the European Union called Invanz.
Danish: Det vil sige, at Ertapenem Hospira skulle have været identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Invanz.
English: No further studies were carried out because Ertapenem Hospira is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Invanz.
Danish: Der er ikke udført yderligere undersøgelser, da Ertapenem Hospira er et generisk lægemiddel, som gives ved infusion og indeholder samme aktive stof som referencelægemidlet Invanz.
English: What is Ertapenem Hospira?
Danish: Hvad er Ertapenem Hospira?
English: At the time of the withdrawal, the CHMP was of the opinion that the company had not addressed its concerns and the quality of Ertapenem Hospira had not been demonstrated.
Danish: CHMP var på tidspunktet for tilbagetrækningen af den opfattelse, at virksomheden ikke havde afhjulpet udvalgets betænkeligheder, og at kvaliteten af Ertapenem Hospira ikke var blevet påvist.
English: Ertapenem Hospira was developed as a ‘generic medicine'.
Danish: Ertapenem Hospira er udviklet som et "generisk lægemiddel".
English: Ertapenem Hospira is an antibiotic medicine that contains the active substance ertapenem.
Danish: Ertapenem Hospira er et antibiotisk lægemiddel, der indeholder det aktive stof ertapenem.
English: Ertapenem can work on a range of different bacteria.
Danish: Ertapenem virker på en række forskellige bakterier.
English: It was to be available as a vial containing a powder which is dissolved before use to make up a solution for infusion (drip) into a vein.
Danish: Det skulle have kunnet fås i hætteglas som et pulver, der efter opløsning indgives ved dråbetilførsel i en vene (infusion).
English: Ertapenem Hospira was also expected to be used to prevent infection at the site of colorectal surgery (surgery in the lower part of the bowel, including the rectum and anus).
Danish: Ertapenem Hospira forventedes desuden anvendt til forebyggelse af infektion ved operationer på tyktarmen og endetarmen (kolorektale infektioner), herunder anus.
English: Ertapenem Hospira is expected to work in the same way as the reference medicine, Invanz.
Danish: Ertapenem Hospira forventes at virke på samme måde som referencelægemidlet Invanz.
English: • foot infections in diabetes patients.
Danish: • fodinfektioner ved sukkersyge (diabetes)
English: The active substance in Ertapenem Hospira and Invanz, ertapenem, belongs to a group of antibiotics known as ‘carbapenems'.
Danish: Det aktive stof i Ertapenem Hospira og Invanz er ertapenem, der er et antibiotikum i gruppen carbapenemer.
English: • gynaecological infections;
Danish: • maveinfektioner
English: How does Ertapenem Hospira work?
Danish: Hvordan virker Ertapenem Hospira?
English: • community-acquired pneumonia (infection of the lungs caught away from hospital);
Danish: • samfundserhvervet lungebetændelse (non-nosokomiel pneumoni)
English: The safety database from these studies comprises 923 patients.
Danish: Sikkerhedsdatabasen fra disse studier omfatter 923 patienter.
English: You can take them with meals or between meals.
Danish: Du kan tage dem sammen med måltider eller mellem måltider.
English: less than 40 kg
Danish: Under 40 kg
English: Frequency not known (cannot be estimated from the available data)
Danish: Hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
English: If this is not the case, your treatment will be delayed.
Danish: Hvis dette ikke er tilfældet, vil din behandling blive udskudt.
English: Your weight
Danish: Din vægt
English: Avoid touching your nose, eyes, and other parts of the body.
Danish: Undgå at berøre din næse, øjne og andre kropsdele.
English: - if you have active cancer.
Danish: - hvis du har aktiv kræft.
English: (1) Open the flap on the left end.
Danish: (1) Åbn fligen på venstre side.
English: Your doctor may need to supervise you more closely.
Danish: Det kan være nødvendigt for din læge at overvåge dig nøjere.
English: It is important to talk to your doctor if you think you have an infection.
Danish: Det er vigtigt at kontakte lægen, hvis du mener, at du har en infektion.
English: • Guidance for patient's monitoring during the treatment;
Danish: • Vejledning for patientens overvågning under behandlingen,
English: • Information on pregnancy prevention.
Danish: • Information om at undgå graviditet.
English: The primary objective of this study was safety, while efficacy endpoints were exploratory.
Danish: Det primære formål med dette studie var sikkerhed, mens endepunkter for virkning var eksplorative.
English: Treatment consists of careful observation and initiation of appropriate supportive measures.
Danish: Behandlingen består af nøje observation og påbegyndelse af passende understøttende behandling.
English: Wash your hands thoroughly with soap and water.
Danish: Vask dine hænder grundigt med sæbe og vand.
English: Talk to your doctor if you have previously had cancer.
Danish: Kontakt lægen, hvis du tidligere har haft kræft.
English: For details, see Tables 1 and 2 below.
Danish: For detaljer se nedenstående tabel 1 og 2.
English: You may have to have the blood irradiated to prevent complications.
Danish: Det kan være nødvendigt at bestråle blodet for at undgå komplikationer.
English: Viale Pasteur, 10 20014 Nerviano (MI) Italy
Danish: Viale Pasteur, 10 20014 Nerviano (MI) Italien
English: The tablets can be taken independent of food intake.
Danish: Tabletterne kan tages uafhængigt af fødeindtagelse.
English: There can be overlaps in the effect on your immune system.
Danish: Der kan være overlappende virkninger på dit immunsystem.
English: PML is a serious condition that may lead to severe disability or death.
Danish: PML er en alvorlig sygdom, der kan føre til svært handicap eller døden.
English: Efficacy in patients with high disease activity
Danish: Virkning hos patienter med høj sygdomsaktivitet
English: Patients with hereditary problems of fructose intolerance should not take this medicinal product.
Danish: Patienter med hereditære problemer med fructoseintolerans bør ikke tage dette lægemiddel.
English: Table 3 Clinical outcomes in the CLARITY study (96 weeks)
Danish: Tabel 3 Kliniske resultater i CLARITY-studiet (96 uger)
English: You will need one or more packs to provide the correct number of tablets.
Danish: Du har brug for en eller flere pakninger for at få det korrekte antal tabletter.
English: Day 1 Day 2 Day 3 Day 4 Day 5
Danish: Dag 1 Dag 2 Dag 3 Dag 4 Dag 5
English: Contact with skin should be limited.
Danish: Hudkontakt bør begrænses.
English: Your immune system must have recovered before you can be vaccinated, and blood tests will check this.
Danish: Dit immunsystem skal have kommet sig, før du kan blive vaccineret, og blodprøver vil kontrollere dette.
English: Re-initiation of therapy after year 4 has not been studied.
Danish: Genoptagelse af behandlingen efter år 4 er ikke undersøgt.
English: Example: if you start your treatment mid April, you take your tablets as shown.
Danish: Eksempel: hvis du starter din behandling i midten af april måned, skal du tage tabletterne som vist.
English: The prescriber / patient guide should include information about the following safety concerns:
Danish: Ordinations- / patientguiden skal omfatte oplysninger om de følgende sikkerhedsovervejelser:
English: This however does not result in any drug accumulation after once daily dosing as this half-life only accounts for a small portion of the AUC.
Danish: Dette fører imidlertid ikke til nogen lægemiddelakkumulationer efter dosering én gang dagligt, da denne halveringstid kun udgør en lille del af AUC.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 August 2017
Danish: Dato for første markedsføringstilladelse: 22. august 2017
English: Your doctor will decide if you need to stop treatment or not.
Danish: Lægen vil beslutte, om du skal stoppe behandlingen eller ej.
English: Make sure you have read all of the package leaflet including the step-by-step guide and keep it in a safe place.
Danish: Sørg for, at du har læst hele indlægssedlen, herunder den trinvise vejledning, og opbevar den på et sikkert sted.
English: Very rare side effect - may affect up to 1 in 10,000 people - tuberculosis
Danish: Meget sjældne bivirkninger - kan forekomme hos op til 1 ud af 10.000 personer - tuberkulose
English: Switching to and from cladribine treatment
Danish: Skift til og fra cladribinbehandling
English: MAVENCLAD is for oral use.
Danish: MAVENCLAD er til oral anvendelse.
English: - if you have moderate or severe kidney problems.
Danish: - hvis du har moderate eller svære nyreproblemer.
English: The following definitions apply to the frequency terminology used hereafter:
Danish: De følgende definitioner gælder for hyppighedsterminologien, som herefter anvendes:
English: Once you have completed the 2 treatment courses over 2 years, your doctor will continue to monitor your health for another 2 years, in which you do not need to take the medicine.
Danish: Når du har gennemført de 2 behandlingsforløb i løbet af 2 år, vil lægen fortsætte med at overvåge dit helbred i endnu 2 år, hvor du ikke behøver at tage lægemidlet.
English: When you receive your supply of medicine, check that you have the correct number of tablets.
Danish: Når du får din lægemiddelforsyning, skal du kontrollere, at du har det korrekte antal tabletter.
English: Careful monitoring of haematological parameters is recommended in such cases.
Danish: Nøje overvågning af hæmatologiske parametre anbefales i sådanne tilfælde.
English: R-Pharm Germany GmbH Heinrich-Mack-Strasse 35 89257 Illertissen Germany
Danish: R-Pharm Germany GmbH Heinrich-Mack-Strasse 35 89257 Illertissen Tyskland
English: Grade 4 lymphopenia was seen in less than 1% of the patients.
Danish: Grad 4 lymfopeni blev observeret hos under 1 % af patienterne.
English: Make sure you know how many tablets are contained in the package.
Danish: Sørg for at du ved, hvor mange tabletter, der er i pakningen.
English: 40 to less than 50 kg 50 to less than 60 kg 60 to less than 70 kg 70 to less than 80 kg 80 to less than 90 kg 90 to less than 100 kg 100 to less than 110 kg
Danish: 40 til under 50 kg 50 til under 60 kg 60 til under 70 kg 70 til under 80 kg 80 til under 90 kg 90 til under 100 kg 100 til under 110 kg 110 kg og derover
English: - If you lose a tablet, contact your doctor for advice.
Danish: - Hvis du mister en tablet, skal du kontakte din læge for rådgivning.
English: If such signs and symptoms occur, antiinfective treatment should be initiated as clinically indicated.
Danish: Hvis der forekommer sådanne tegn og symptomer, bør behandling af infektionen påbegyndes efter klinisk indikation.
English: Example: if you weigh 85 kg and are about to start treatment week 1, you will be given 8 tablets.
Danish: Eksempel: hvis du vejer 85 kg og skal til at starte behandlingsuge 1, vil du få 8 tabletter.
English: Keep your tablets in the blister until your next dose.
Danish: Opbevar tabletterne i blisteren indtil din næste dosis.
English: An effect on disability progression could not be shown in either subgroup.
Danish: Der kunne ikke vises en virkning på sygdomsprogressionen i nogen af undergrupperne.
English: Criteria for initiating and continuing therapy
Danish: Kriterier for initiering og fortsættelse af behandlingen
English: Infection with human immunodeficiency virus (HIV).
Danish: Infektion med human immundefektvirus (hiv).
English: If the number of tablets in your pack(s) is different from the number shown for your weight in the table below, speak to your doctor.
Danish: Hvis antallet af tabletter i din/dine pakning(er) er forskelligt fra antallet vist for din vægt i tabellen nedenfor, skal du tale med lægen.
English: Following oral administration, cladribine is rapidly absorbed.
Danish: Efter oral administration absorberes cladribin hurtigt.
English: Dose and time dependence
Danish: Dosis og tidsafhængighed
English: Depending on the total number of tablets you have been prescribed, you have to take them over 4 or 5 days, in each treatment week.
Danish: Afhængigt af det totale antal tabletter, du har fået ordineret, skal du tage dem i løbet af 4 eller 5 dage, i hver behandlingsuge.
English: The estimated terminal half-life for a typical patient from the population pharmacokinetic analysis is approximately 1 day.
Danish: Den estimerede terminale halveringstid for en typisk patient fra den populationsfarmakokinetiske analyse er ca. 1 dag.
English: Rash, alopecia.
Danish: Udslæt, alopeci.
English: If you miss a dose and do not remember it until the following day
Danish: Hvis du glemmer en dosis, og ikke husker det før den følgende dag
English: Over two thirds of the study patients were treatment-naive for MS disease-modifying drugs (DMDs).
Danish: Mere end to tredjedele af patienterne i studiet var behandlingsnaive over for sygdomsmodificerende MS-lægemidler (DMD'er).
English: - certain types of vaccines (live and live attenuated vaccines).
Danish: - visse vaccinetyper (levende og levende svækkede vacciner).
English: • A reminder to carefully consider data on blood count monitoring and screening for latent infections before starting the treatment;
Danish: • En påmindelse om at nøje overveje data fra overvågning af blodtal, og screening af latente infektioner, før behandlingen startes,
English: Raise the blister pack by pushing your finger through the hole in the tray.
Danish: Løft blisterpakningen ved at trykke fingeren gennem hullet i bakken.
English: Your doctor will give you guidance on appropriate methods of contraception.
Danish: Lægen vil give dig vejledning i passende præventionsmetoder.