FrancophonIA/ELRC3.0 huggingface dataset:
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER CARTON OF 5 MG FILM-COATED TABLETS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTERPANING MED 5 MG FILMOVERTRUKNE TABLETTER
English: OPA/Aluminium/PE/Desiccant/PE- Aluminium blister packs containing 28, 30, 84 or 98 film-coated tablets.
Danish: OPA/Aluminium/PE/Tørremiddel/PE- aluminiumblisterpakninger, der indeholder 28, 30, 84 eller 98 filmovertrukne tabletter.
English: What you need to know before you take Prasugrel Mylan
Danish: Det skal du vide, før du begynder at tage Prasugrel Mylan
English: Switching data
Danish: Data om behandlingsskift
English: Platelet aggregation gradually returned to baseline values after treatment in 7 to 9 days after administration of a single 60 mg loading dose of prasugrel and in 5 days following discontinuation of maintenance dosing at steady-state.
Danish: I løbet af 7 til 9 dage efter administration af en enkelt støddosis på 60 mg prasugrel og i løbet af 5 dage efter seponering af vedligeholdelsesdosis ved steady state, vendte trombocytaggregationen gradvist tilbage til baselineværdierne.
English: Blister packs only: Do not store above 30°C.
Danish: Kun blisterpakninger: Må ikke opbevares ved temperaturer over 30 °C.
English: f Clinically overt bleeding associated with a fall in haemoglobin of ≥3 g/dL but <5 g/dL.
Danish: f Klinisk tydelig blødning, der er forbundet med et fald i hæmoglobin ≥ 3 g/dl men < 5 g/dl.
English: 3.0% (0.5% fatal)
Danish: 3,0 % (0,5 % dødelige)
English: 3.8% (0.2% fatal)
Danish: 3,8 % (0,2 % dødelige)
English: Prasugrel Mylan 5 mg film-coated tablets are yellow film-coated, capsule shaped, biconvex tablets, of dimensions 8.15 mm × 4.15 mm, debossed with ‘PH3' on one side of the tablet and ‘M' on the other side.
Danish: Prasugrel Mylan 5 mg filmovertrukne tabletter er gule filmovertrukne, kapselformede, bikonvekse tabletter med dimensionerne 8,15 mm × 4,15 mm, der er præget med ”PH3” på den ene side og ”M” på den anden side.
English: What Prasugrel Mylan is and what it is used for What you need to know before you take Prasugrel Mylan How to take Prasugrel Mylan Possible side effects
Danish: Det skal du vide, før du begynder at tage Prasugrel Mylan Sådan tages Prasugrel Mylan Bivirkninger
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Danish: Må ikke opbevares ved temperaturer over 25 °C.
English: Concomitant administration with chronic NSAIDs has not been studied.
Danish: Non-steroide antiinflammatoriske midler (NSAIDs) Administration af Prasugrel Mylan samtidig med vedvarende behandling med NSAIDs er ikke undersøgt.
English: Retroperitoneal haemorrhage Rectal haemorrhage Haematochezia Gingival bleeding
Danish: Retroperitoneal blødning Rektalblødning Friskt rødt blod i afføring
English: ≥75 years (N=1785)*
Danish: ≥ 75 år (N = 1.785)*
English: McDermott Laboratories t/a Gerard Laboratories t/a Mylan Dublin 35/36 Baldoyle Industrial Estate
Danish: McDermott Laboratories under forretningsnavnet Gerard Laboratories under forretningsnavnet Mylan Dublin
English: BLISTER CARTON OF 10 MG FILM-COATED TABLETS
Danish: BLISTERPAKNING MED 10 MG FILMOVERTRUKNE TABLETTER
English: Prasugrel Mylan 10 mg film-coated tablets are beige film-coated, capsule shaped, biconvex tablets, of dimensions 11.15 mm × 5.15 mm, debossed with ‘PH4' on one side of the tablet and ‘M' on the other side.
Danish: Prasugrel Mylan 10 mg filmovertrukne tabletter er beigefarvede filmovertrukne, kapselformede, bikonvekse tabletter med dimensionerne 11,15 mm × 5,15 mm, der er præget med ”PH4” på den ene side og ”M” på den anden side.
English: BLISTER CARTON OF 5 MG FILM-COATED TABLETS
Danish: BLISTERPAKNING MED 5 MG FILMOVERTRUKNE TABLETTER
English: Method of administration
Danish: Administration af
English: Since platelets participate in the initiation and/or evolution of thrombotic complications of atherosclerotic disease, inhibition of platelet function can result in the reduction of the rate of cardiovascular events such as death, myocardial infarction, or stroke.
Danish: kan hæmning af trombocytfunktionen medføre reduktion i antallet af kardiovaskulære tilfælde såsom død, myokardieinfarkt eller slagtilfælde.
English: Each tablet contains prasugrel besilate equivalent to 10 mg prasugrel.
Danish: Hver tablet indeholder prasugrelbesilat svarende til 10 mg prasugrel.
English: 1.6% (0.2% fatal)
Danish: 1,6 % (0,2 % dødelige)
English: Do not break or crush the tablet.
Danish: Tabletten må ikke knækkes eller knuses.
English: Beige film-coated, capsule shaped, biconvex tablet, of dimensions 11.15 mm × 5.15 mm, debossed with ‘PH4' on one side and ‘M' on the other side.
Danish: Beige, filmovertrukket, kapselformet, bikonveks tablet med størrelsen 11,15 mm × 5,15 mm, præget med ”PH4” på den ene side og ”M” på den anden side.
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C.
Danish: Må ikke opbevares ved temperaturer over 30 °C.
English: Each tablet contains prasugrel besilate equivalent to 5 mg prasugrel.
Danish: Hver tablet indeholder prasugrelbesilat svarende til 5 mg prasugrel.
English: Yellow film-coated, capsule shaped, biconvex tablet, of dimensions 8.15 mm × 4.15 mm, debossed with ‘PH3' on one side and ‘M' on the other side.
Danish: Gul, filmovertrukket, kapselformet, bikonveks tablet med størrelsen 8,15 mm × 4,15 mm, præget med ”PH3” på den ene side og ”M” på den anden side.
English: Results of a pharmacodynamic/pharmacogenomic study in 720 Asian ACS PCI patients demonstrated that higher levels of platelet inhibition are achieved with prasugrel compared to clopidogrel, and that prasugrel 60 mg loading dose/10 mg maintenance dose is an appropriate dose regimen in Asian subjects who weigh at least 60 kg and are less than 75 years of age (see section 4.2).
Danish: Studiet viste endvidere, at 60 mg prasugrel støddosis/10 mg vedligeholdelsesdosis er en passende dosering til asiatiske patienter, som vejer mindst 60 kg, og som er yngre end 75 år (se pkt.
English: TIMI major bleedingc
Danish: TIMI større blødningc
English: Titanium dioxide (E171)
Danish: Titandioxid (E171) Glyceryl monocaprylocaprat
English: 2.9% (0.1% fatal)
Danish: 2,9 % (0,1 % dødelige)
English: 6.9% (0.1% fatal)
Danish: 6,9 % (0,1 % dødelige)
English: 6.5% (0.3% fatal)
Danish: 6,5 % (0,3 % dødelige)
English: Because of the potential for increased risk of bleeding, warfarin and Prasugrel Mylan should be co-administered with caution (see section 4.4).
Danish: På grund af muligheden for øget blødningsrisiko bør der udvises forsigtighed ved samtidig administration af warfarin og Prasugrel Mylan (se pkt.
English: Therefore, prasugrel can be administered without regard to food; however, the administration of prasugrel loading dose in the fasted state may provide most rapid onset of action (see section 4.2).
Danish: Det er dog muligt, at administration af prasugrel støddosis under faste kan give den hurtigst indsættende virkning (se pkt.
English: Sodium lauryl sulfate
Danish: Natriumlaurylsulfat
English: 3.3% (0.1% fatal)
Danish: 3,3 % (0,1 % dødelige)
English: EU/1/18/1273/001 EU/1/18/1273/003
Danish: EU/1/18/1273/003
English: Prasugrel 5 mg Mylan contains sodium
Danish: Prasugrel Mylan 5 mg indeholder natrium
English: ◦ Patients weighing <60 kg should have a reduced maintenance dose of 5 mg
Danish: 4.4), bør det ordineres som en 60 mg støddosis efterfulgt af en lavere vedligeholdelsesdosis på 5 mg. ◦ Patienter med en vægt < 60 kg bør have en reduceret vedligeholdelsesdosis på 5 mg.
English: Patients with a history of TIA or a history of ischaemic stroke more than 3 months prior to prasugrel therapy had no reduction in the primary composite endpoint.
Danish: Der var ingen reduktion i primære sammensatte endepunktshændelser for de patienter, som havde en sygehistorie med TIA eller en sygehistorie med iskæmisk slagtilfælde mere end 3 måneder før prasugrelbehandling.
English: Patients ≥75 years were at increased risk of bleeding, including fatal (see sections 4.2, 4.4, and 4.8).
Danish: Patienter ≥ 75 år havde øget risiko for blødning, inklusive letale risici (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Prasugrel Mylan 5 mg film-coated tablets Prasugrel Mylan 10 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Prasugrel Mylan 5 mg filmovertrukne tabletter Prasugrel Mylan 10 mg filmovertrukne tabletter
English: If you stop taking Prasugrel Mylan
Danish: Hvis du holder op med at tage Prasugrel Mylan:
English: 2.6% (0.3% fatal)
Danish: 2,6 % (0,3 % dødelige)
English: 4.2% (0.3% fatal)
Danish: 4,2 % (0,3 % dødelige)
English: • Before you take Prasugrel Mylan:
Danish: • Før du tager Prasugrel Mylan
English: Lifethreateningd
Danish: Livstruended
English: 1.4% (0.1% fatal)
Danish: 1,4 % (0,1 % dødelige)
English: Prasugrel Mylan 10 mg film-coated tablets prasugrel
Danish: Prasugrel Mylan 10 mg filmovertrukne tabletter prasugrel
English: If you take more Prasugrel Mylan than you should Contact your doctor or hospital straight away, as you may be at risk of excessive bleeding.
Danish: Kontakt din læge eller skadestuen øjeblikkeligt på grund af den øgede blødningsrisiko.
English: Prasugrel Mylan 5 mg film-coated tablets Prasugrel Mylan 10 mg film-coated tablets prasugrel
Danish: Prasugrel Mylan 5 mg filmovertrukne tabletter Prasugrel Mylan 10 mg filmovertrukne tabletter prasugrel
English: Talc
Danish: Batch
English: 2.2% (0.3% fatal)
Danish: 2,2 % (0,3 % dødelige)
English: NAME OF THE MEDICINAL PRODUCT Prasugrel Mylan 5 mg film-coated tablets Prasugrel
Danish: LÆGEMIDLETS NAVN Prasugrel Mylan 5 mg filmovertrukne tabletter Prasugrel
English: NAME OF THE MEDICINAL PRODUCT Prasugrel Mylan 10 mg film-coated tablets Prasugrel
Danish: LÆGEMIDLETS NAVN Prasugrel Mylan 10 mg filmovertrukne tabletter Prasugrel
English: Prasugrel Mylan 5 mg film-coated tablets prasugrel
Danish: Prasugrel Mylan 5 mg filmovertrukne tabletter prasugrel
English: Prasugrel + ASA
Danish: Endepunktshændelser Prasugrel +
English: 1.3% (0.1% fatal)
Danish: 1,3 % (0,1 % dødelige)
English: Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, dietary supplements and herbal remedies.
Danish: - Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: These may be signs of a severe allergic reaction (see section 2 ‘What you need to know before you take Prasugrel Mylan')
Danish: Dette kan være tegn på en alvorlig allergisk reaktion (se pkt.
English: How to take Prasugrel Mylan
Danish: Sådan skal du tage Prasugrel Mylan
English: BOTTLE CARTON AND BOTTLE LABEL OF 5 MG FILM-COATED TABLETS
Danish: MÆRKNING PÅ BEHOLDERÆSKE OG BEHOLDER TIL 5 MG FILMOVERTRUKNE TABLETTER
English: BOTTLE CARTON AND BOTTLE LABEL OF 10 MG FILM-COATED TABLETS
Danish: MÆRKNING PÅ BEHOLDERPAKNING OG BEHOLDER TIL 10 MG FILMOVERTRUKNE TABLETTER
English: Prasugrel Mylan 10 mg contains sunset yellow FCF aluminium lake (E110) and sodium Sunset yellow FCF aluminium lake is an azo colouring agent, which may cause allergic reactions.
Danish: Prasugrel Mylan 10 mg indeholder Sunset yellow FCF aluminium lake (E110) og natrium.
English: It was to be used in combination with other medicines.
Danish: Det skulle have været brugt i kombination af andre lægemidler.
English: It was to be available as capsules (120 mg).
Danish: Det var meningen, at det skulle leveres som kapsler (120 mg).
English: Remaining clinical trials were expected to finish on schedule by July 2014.
Danish: De resterende kliniske undersøgelser forventes afsluttet som planlagt i juli 2014.
English: 27 June 2014 EMA/354906/2014 EMEA/H/C/003720
Danish: Den 27. juni 2014 EMA/445609/2014 EMEA/H/C/003720
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 først havde indsendt, og stillet en række spørgsmål.
English: The main measure of effectiveness was the number of patients whose blood tests did not show any sign of hepatitis C virus 12 weeks after
Danish: Behandlingens virkning blev hovedsagelig bedømt på den andel af patienterne, hvis blodprøver ikke viste tegn på hepatitis C-virus 12 uger efter afslutningen af behandlingen.
English: A fourth study involving 308 patients examined the effects of treatment with Faldeprevir Boehringer Ingelheim in patients who also had HIV infection.
Danish: En fjerde undersøgelse med 308 patienter vedrørte virkningerne af behandlingen med Faldaprevir Boehringer Ingelheim hos patienter, der desuden var smittet med hiv.
English: This stops the hepatitis C virus from multiplying and infecting new cells.
Danish: Derved bliver hepatitis C-virusset ude af stand til at formere sig og inficere nye celler.
English: On 10 June 2014, Boehringer Ingelheim International GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Faldaprevir Boehringer Ingelheim, for the treatment of hepatitis C.
Danish: Den 10. juni 2014 meddelte Boehringer Ingelheim International GmbH officielt til Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om markedsføringstilladelse for Faldaprevir Boehringer Ingelheim til behandling af hepatitis C.
English: The company presented data including the results of three main studies involving 1,705 patients with chronic hepatitis C, in which faldaprevir was compared with placebo (a dummy treatment) when added to two other medicines for hepatitis C, peginterferon and ribavirin.
Danish: Virksomheden fremlagde resultaterne af tre hovedundersøgelser med 1 705 patienter med kronisk hepatitis C. Faldaprevir blev her sammenlignet med virkningsløs behandling (placebo) som tillægsbehandling til to andre lægemidler mod hepatitis C, peginterferon og ribavirin.
English: In addition, results of tests on capsules stored in nonrefrigerated conditions showed that they did not dissolve as expected, which could affect the release of the active substance from the capsule.
Danish: Desuden viste testen af kapsler, der ikke var blevet opbevaret køligt, at de ikke blev opløst som forventet.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse med Faldaprevir Boehringer Ingelheim og har behov for yderligere oplysninger om din behandling, kan du kontakte den læge, der giver dig behandlingen.
English: Several varieties (genotypes) of hepatitis C virus exist: Faldaprevir Boehringer Ingelheim was intended to be used against genotype 1.
Danish: Der findes flere varianter (genotyper) af hepatitis C-virus: Det var meningen, at Faldaprevir Boehringer Ingelheim skulle anvendes mod genotype 1.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that since several new treatments for hepatitis C had become available after the application was first made, there was no longer an unmet medical need for such a medicine.
Danish: I det brev, hvori virksomheden underrettede agenturet om tilbagetrækningen af ansøgningen, anførte virksomheden, at der efter den oprindelige indsendelse af ansøgningen var fremkommet flere nye midler mod hepatitis C. Der var derfor ikke længere et uopfyldt behov for et sådant lægemiddel.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had had some concerns and was of the provisional opinion that Faldaprevir Boehringer Ingelheim could not have been approved for the treatment of hepatitis C. The Committee had concerns regarding the starting materials used for the manufacture of the active substance.
Danish: På baggrund af gennemgangen af de oplysninger, der forelå på tidspunktet for tilbagetrækningen, havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Faldaprevir Boehringer Ingelheim ikke kunne være blevet godkendt til behandling af hepatitis C. Udvalgets betænkeligheder vedrørte de udgangsmaterialer, der blev anvendt til at fremstille det aktive indholdsstof.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Faldaprevir Boehringer Ingelheim.
Danish: Virksomheden har til CHMP oplyst, at tilbagetrækningen ikke har konsekvenser for patienter, som i øjeblikket deltager i kliniske undersøgelser med Faldaprevir Boehringer Ingelheim.
English: Faldaprevir Boehringer Ingelheim is an antiviral medicine that contains the active substance faldaprevir.
Danish: Faldaprevir Boehringer Ingelheim er et lægemiddel mod virus (et antiviralt lægemiddel), der indeholder det aktive stof faldaprevir.
English: Therefore, up to the time of the withdrawal, the CHMP was of the opinion that due to the concerns about quality the benefits of Faldaprevir Boehringer Ingelheim did not outweigh its risks.
Danish: Derfor var CHMP op til tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Faldaprevir Boehringer Ingelheim ikke opvejede risiciene på grund af betænkeligheder vedrørende kvaliteten.
English: What is Faldaprevir Boehringer Ingelheim?
Danish: Hvad er Faldaprevir Boehringer Ingelheim?
English: The active substance in Faldaprevir Boehringer Ingelheim, faldaprevir, blocks the action of an enzyme called ‘NS3/4A serine protease' in the hepatitis C virus, which is essential for the virus to multiply.
Danish: Det aktive stof i Faldaprevir Boehringer Ingelheim, faldaprevir, blokerer virkningen af enzymet NS3/4A serinprotease i hepatitis C-virusset.
English: What was Faldaprevir Boehringer Ingelheim expected to be used for?
Danish: Hvad forventedes Faldaprevir Boehringer Ingelheim anvendt til?
English: Faldaprevir Boehringer Ingelheim was expected to be used to treat adults with chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).
Danish: Faldaprevir Boehringer Ingelheim forventedes anvendt til behandling af langvarig (kronisk) hepatitis C hos voksne.
English: How is Faldaprevir Boehringer Ingelheim expected to work?
Danish: Hvordan forventes Faldaprevir Boehringer Ingelheim at virke?
English: What consequences does this withdrawal have for patients in clinical trials?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Faldaprevir Boehringer Ingelheim?
English: In an independent published study,
Danish: I et uafhængigt publiceret studie,
English: *This also applies to patients aged 15 years and older.
Danish: * Dette gælder også patienter på 15 år og ældre.
English: This product should only be taken under the supervision of a doctor.
Danish: Denne medicin bør kun bruges under tilsyn af en læge.
English: The expiry date refers to the last day of that month.
Danish: Udløbsdatoen er den sidste i den nævnte måned.
English: [Mechanism of interaction]
Danish: [Interaktionsmekanisme]
English: The asterisk (*) indicates a two-way interaction.
Danish: En asterix (*) indikerer en to-vejs interaktion.
English: Your treatment will be started as an infusion
Danish: Behandlingen af barnet vil blive startet som en indsprøjtning.
English: For example, 15-20 % of Asian populations may be expected to be poor metabolisers.
Danish: For eksempel forventes det, at det hos 15-20% af de asiatiske populationer metaboliseres dårligt.
English: The following instructions apply to both treatment and prophylaxis
Danish: Følgende instruktioner angår både behandling og profylakse
English: In addition, a successful response was seen in 1 of 3 patients with infections caused by more than one organism including Scedosporium spp.
Danish: Derudover sås et succesrigt respons hos 1 ud af 3 patienter med infektioner, forårsaget af mere end en organisme, herunder Scedosporium spp.
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest godkendt i {MM/ÅÅÅÅ}.
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLERE ANSVARLIG(E) 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: Scedosporium and Fusarium infections
Danish: Scedosporium og Fusarium-infektioner
English: It is important to take your Voriconazole Accord tablets regularly at the same time each day.
Danish: Det er vigtigt, at De tager Voriconazole Accord-tabletter regelmæssigt på samme tidspunkt hver dag.
English: Careful monitoring of blood glucose is recommended.
Danish: Omhyggelig monitorering af blodglukose anbefales.
English: Reminds patients when and how to report relevant signs and symptoms of phototoxicity and skin cancer.
Danish: - Påminde patienter om, hvornår og hvordan de skal indberette relevante tegn og symptomer på fototoksicitet og hudcancer.
English: Prophylaxis in adults and children
Danish: Profylakse hos voksne og børn
English: [increases gastric pH]
Danish: [øger gastrisk pH]
English: Close monitoring of prothrombin time or other suitable anticoagulation tests is recommended and the dose of anticoagulants should be adjusted accordingly.
Danish: Tæt monitorering af protrombintid eller andre passende antikoagulations-test anbefales og dosis af antikoagulantia bør tilsvarende justeres.
English: For Caucasians and Blacks the prevalence of poor metabolisers is 3-5 %.
Danish: Blandt kaukasiere og personer af negroid afstamning er prævalensen af personer med dårlig metaboliseringsevne 3-5%.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 May 2013
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 16. maj 2013 Dato for seneste fornyelse: 8. februar 2018
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendix V.Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Success was defined as the ability to continue study drug prophylaxis for 100 days after HSCT (without stopping for >14 days) and survival with no proven or probable IFI for 180days after HSCT.
Danish: Succeskriteriet blev defineret som evnen til at fortsætte profylakse med studielægemidlet i 100 dage efter HSCT (uden at stoppe i >14 dage) og til at overleve uden påvist eller sandsynlig invasiv svampeinfektion i 180 dage efter HSCT.
English: Astemizole, cisapride, pimozide, quinidine and terfenadine
Danish: Astemizol, cisaprid, pimozid, quinidin and terfenadin
English: Side effects with frequency not known: - Freckles and pigmented spots
Danish: Bivirkninger med ikke kendt hyppighed: • Fregner og pigmentpletter.
English: Efavirenz (a non-nucleoside reverse transcriptase inhibitor)
Danish: Efavirenz (en non-nukleosid reverse transcriptase-hæmmer)
English: It is important to cover sun exposed areas of skin and use sunscreen with high sun protection factor (SPF),, as an increased sensitivity of skin to the sun's UV rays can occur.
Danish: Det er vigtigt at tildække huden og bruge solcreme med høj solbeskyttelsesfaktor (SPF), da De kan være særlig følsom for solens UV stråler.
English: It may only be continued up to 180 days after transplantation in case of continuing immunosuppression or graft versus host disease (GvHD) (see section 5.1).
Danish: Behandling må kun fortsættes i op til 180 dage efter transplantationen i tilfælde af vedvarende immunsuppression eller graft-versus-host sygdom (GvHD) (se pkt.