FrancophonIA/ELRC3.0 huggingface dataset:
English: - For patients with complicated pelvic inflammatory disease (e.g. associated with a tubo-ovarian or pelvic abscess), for whom an intravenous treatment is considered necessary, treatment with [Invented name] 400 mg film-coated tablets is not recommended.
Danish: - [Lægemidlets navn] 400 mg filmovertrukne tabletter bør ikke anvendes til patienter med kompliceret bækkenbetændelse (f.eks. forbundet med abscess i æggestokkene eller bækkenet), hvor intravenøs behandling skønnes nødvendig.
English: - If your eyesight becomes impaired or if you have any other eye disturbances whilst taking [Invented name], consult an eye specialist immediately.
Danish: - Hvis Deres syn bliver forringet, eller hvis De oplever andre øjenforstyrrelser under behandlingen med [Lægemidlets navn], skal De straks kontakte lægen.
English: - Due to adverse effects on the cartilage in juvenile animals (see section 5.3) the use of moxifloxacin in children and adolescents < 18 years is contraindicated (see section 4.3).
Danish: - Anvendelsen af moxifloxacin til børn og unge under 18 år er kontraindiceret (se pkt.
English: The review of available guidelines and clinical efficacy data showed that moxifloxacin can be used for treatment of PID in the sense of a monotherapy only after results of microbiological testing are available.
Danish: Ved en gennemgang af tilgængelige retningslinjer og kliniske data for virkning fandt man, at moxifloxacin som monoterapi kun kan bruges til behandling af PID, når der foreligger resultater fra mikrobiologiske test. I klinisk praksis sker dette kun i tilfælde af, at det ikke er muligt at anvende en kombination med et godkendt stof, der er aktivt imod fluoroquinolon-resistent N. gonorrhoeae, eller i tilfælde af anden fejlslagen behandling.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines besides [Invented name], including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller apoteket, hvis De bruger anden medicin eller har brugt det for nyligt.
English: - For the treatment of mild to moderate infections of the female upper genital tract your doctor should prescribe another antibiotic in addition to [Invented name].
Danish: - Deres læge skal desuden ordinere anden antibiotisk medicin ud over [Lægemidlets navn] til behandling af mild til moderat betændelse i den øvre del af underlivet.
English: pseudomembranous colitis) has been reported in association with the use of broad spectrum antibiotics including moxifloxacin; therefore it is important to consider this diagnosis in patients who develop serious diarrhoea during or after the use of moxifloxacin.
Danish: - Antibiotikarelateret kolitis (inklusive pseudomembranøs kolitis) er blevet indberettet i forbindelse med brugen af bredspektrede antibiotika, inklusive moxifloxacin.
English: Before you take [Invented name] ..., Take special care ...).
Danish: Vær ekstra forsigtig med at tage [Lægemidlets navn]).
English: Aerobic Gram-negative micro-organisms Haemophilus influenzae*
Danish: Haemophilus influenzae*
English: H. influenzae and M. catarrhalis
Danish: H. influenzae og M. catarrhalis ≤ 0.5 mg/l
English: Greece
Danish: Belgien
English: AVELOX 400 mg filmsko obložene tablete
Danish: Avelox 400 mg Filmtabletten
English: Contact your doctor if you are not sure if you belong to a patient group described below.
Danish: Kontakt lægen, før De tager [Lægemidlets navn], hvis lægen har fortalt Dem, at De ikke tåler visse sukkerarter.
English: Aerobic Gram-positive micro-organisms Gardnerella vaginalis
Danish: Gardnerella vaginalis
English: Acute sinusitis 7 days - Mild to moderate pelvic inflammatory disease 14 days
Danish: - 14 dage ved mild til moderat betændelse i de øvre dele af kvindens underliv
English: Unless otherwise indicated by your doctor the recommended durations of use of [Invented name] are: - Sudden worsening of chronic bronchitis (acute exacerbation of chronic bronchitis) 10 days - Infection of the lungs acquired (pneumonia) outside the hospital, except severe cases days - Acute infection of the sinuses (acute bacterial sinusitis) days - Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease),
Danish: Følgende behandlingsvarighed anbefales for [Lægemidlets navn] 400 mg filmovertrukne tabletter: - Akut forværring af kronisk bronkitis: 5-10 dage - Ikke hospitalserhvervet lungebetændelse: 10 dage - Akut sinuitis: 7 dage - Mild til moderat bækkenbetændelse: 14 dage
English: You should check with your doctor or pharmacist if you are not sure how to take [Invented name].
Danish: Spørg lægen eller apoteket hvis der er noget, De er i tvivl om eller følger Dem usikker på.
English: Duration of administration [Invented name] 400 mg film-coated tablets should be used for the following treatment durations: Acute exacerbation of chronic bronchitis
Danish: Hvis ikke andet er angivet af Deres læge, er den anbefalede behandlingsvarighed af [Lægemidlets navn]: - 5-10 dage ved pludselig forværring af kronisk bronkitis (akut forværring af kronisk bronkitis).
English: It contains the active
Danish: Det indeholder det
English: The European Commission granted a marketing authorisation valid throughout the EU for Filgrastim ratiopharm to ratiopharm GmbH on 15 September 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Filgrastim ratiopharm til ratiopharm GmbH den 15. september 2008.
English: This means that Filgrastim ratiopharm is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘reference medicine').
Danish: Det betyder, at Filgrastim ratiopharm svarer til et biologisk lægemiddel, som allerede er godkendt i Den Europæiske Union (EU), og som indeholder det samme aktive stof (også kendt som "referencelægemidlet").
English: Other side effects may be seen in more than 1 patient in 10, depending on the condition that Filgrastim ratiopharm is being used for.
Danish: Andre bivirkninger kan optræde hos flere end 1 ud af 10 patienter, afhængig af den tilstand, som Filgrastim ratiopharm anvendes til behandling af.
English: The most common side effect with Filgrastim ratiopharm (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
Danish: Den hyppigste bivirkning ved Filgrastim ratiopharm (som ses hos mere end 1 ud af hver 10 patienter) er muskelsmerter (smerter i muskler og knogler).
English: The active substance in Filgrastim ratiopharm, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Danish: Det aktive stof i Filgrastim ratiopharm, filgrastim, svarer i høj grad til et humant protein kaldet granulocyt kolonistimulerende faktor (G-CSF).
English: Filgrastim ratiopharm can also be used in patients who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow.
Danish: Filgrastim ratiopharm kan også anvendes til patienter, der skal donere blodstamceller til transplantation, for at bidrage til at frigøre disse celler fra knoglemarven.
English: During the first 21-day chemotherapy cycle, patients treated with either Filgrastim ratiopharm or Neupogen had severe neutropenia for an average of 1.1 days, compared with 3.8 days in those receiving placebo.
Danish: I løbet af deres første kemoterapicyklus på 21 dage havde patienter behandlet med Filgrastim ratiopharm eller Neupogen svær neutropeni i gennemsnitligt 1,1 dag sammenlignet med 3,8 dage hos dem, der fik placebo.
English: Filgrastim ratiopharm is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately.
Danish: Filgrastim ratiopharm gives sædvanligvis på et specialiseret behandlingscenter, selvom de patienter, der får lægemidlet gennem injektion under huden, selv kan give injektionerne, når de først er blevet behørigt instrueret heri.
English: To study the safety of Filgrastim ratiopharm, two further studies were carried out in patients with lung cancer and with non-Hodgkin's lymphoma.
Danish: For at undersøge sikkerheden af Filgrastim ratiopharm blev der gennemført to undersøgelser af patienter med lungecancer og non-Hodgkin's lymfom (en form for lymfekræft).
English: Filgrastim ratiopharm was compared to Neupogen and to placebo (a dummy treatment) in one main study involving 348 patients with breast cancer.
Danish: Filgrastim ratiopharm blev sammenlignet med Neupogen og placebo (en virkningsløs behandling) i en hovedundersøgelse af 348 patienter med brystcancer.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Filgrastim ratiopharm has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) fandt, at Filgrastim ratiopharm i overensstemmelse med EU's krav har en profil med hensyn til kvalitet, sikkerhed og virkning, som svarer til Neupogen.
English: Filgrastim ratiopharm is used to stimulate the production of white blood cells in the following
Danish: Filgrastim ratiopharm anvendes til at stimulere dannelsen af hvide blodlegemer i følgende tilfælde:
English: Filgrastim ratiopharm is a ‘biosimilar' medicine.
Danish: Filgrastim ratiopharm er et ‘biosimilært' lægemiddel.
English: • to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving chemotherapy (cancer treatment) that is cytotoxic (cell-killing);
Danish: • til at reducere varigheden af neutropeni (lavt antal af neutrofiler, en type hvide blodlegemer) og forekomsten af febril neutropeni (neutropeni med feber) hos patienter, der får kemoterapi (cancerbehandling), som er cytotoksisk (celledræbende)
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) FILGRASTIM RATIOPHARM
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) FILGRASTIM RATIOPHARM EPAR - Sammendrag for offentligheden
English: • to treat persistent neutropenia in patients with advanced human immunodeficiency virus (HIV) infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
Danish: • til at behandle vedvarende neutropeni hos patienter med fremskreden hiv-infektion for at reducere risikoen for bakterielle infektioner, når andre behandlingsmuligheder ikke er hensigtsmæssige.
English: The full EPAR for Filgrastim ratiopharm can be found here.
Danish: Den fuldstændige EPAR for Filgrastim ratiopharm findes her.
English: Filgrastim ratiopharm was studied to show that it is comparable to the reference medicine, Neupogen.
Danish: Filgrastim ratiopharm blev undersøgt for at påvise, at det er sammenligneligt med referencelægemidlet
English: The Committee recommended that Filgrastim ratiopharm be given marketing
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Filgrastim
English: Filgrastim ratiopharm is given by injection under the skin or infusion into a vein.
Danish: Filgrastim ratiopharm gives ved injektion under huden eller ved infusion i en vene.
English: Filgrastim ratiopharm should not be used in people who may be hypersensitive (allergic) to filgrastim
Danish: Filgrastim ratiopharm bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for filgrastim eller andre af indholdsstofferne.
English: The reference medicine for Filgrastim ratiopharm is Neupogen.
Danish: Referencelægemidlet for Filgrastim ratiopharm er Neupogen.
English: Treatment with Filgrastim ratiopharm and Neupogen brought about similar reductions in duration of severe neutropenia.
Danish: Behandling med Filgrastim ratiopharm mindskede varigheden af svær neutropeni på tilsvarende måde som Neupogen.
English: Filgrastim ratiopharm is a solution for injection or for infusion (drip into a vein).
Danish: Filgrastim ratiopharm er en opløsning til injektion eller infusion (drop i en vene).
English: What is the risk associated with Filgrastim ratiopharm?
Danish: Hvilken risiko er der forbundet med Filgrastim ratiopharm?
English: For the full list of all side effects reported with Filgrastim ratiopharm, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Filgrastim ratiopharm fremgår af
English: For more information on biosimilar medicines, see the question-and-answer
Danish: Der kan indhentes yderligere oplysninger om biosimilære lægemidler i
English: Therefore, the effectiveness of Filgrastim ratiopharm was shown to be
Danish: Virkningen af Filgrastim ratiopharm viste sig derfor at svare til
English: What benefit has Filgrastim ratiopharm shown during the studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Filgrastim ratiopharm?
English: How has Filgrastim ratiopharm been studied?
Danish: Hvordan anvendes Filgrastim ratiopharm?
English: How does Filgrastim ratiopharm work?
Danish: Hvordan virker Filgrastim ratiopharm?
English: Date of first authorisation: 16 July 2008 Date of latest renewal: 17 December 2012
Danish: Dato for første tilladelse: 16. juli 2008 Dato for seneste fornyelse: 17. december 2012
English: Very rare, not known*
Danish: Meget sjælden ikke kendt*
English: (listed in section 6).
Danish: (se afsnit 6)
English: Some other medicines may influence the use of Clopidogrel Zentiva or vice versa.
Danish: Visse andre lægemidler kan påvirke brugen af Clopidogrel Zentiva eller omvendt.
English: However, due to the lack of interaction studies with other NSAIDs it is presently unclear whether there is an increased risk of gastrointestinal bleeding with all NSAIDs.
Danish: Imidlertid er det på grund af manglen på interaktionsstudie med andre NSAID'er ikke umiddelbart klart, om der er øget risiko for gastrointestinal blødning med alle NSAIDpræparater.
English: • if you have had an allergy or reaction to any medicine used to treat your disease.
Danish: • hvis du har haft en allergi eller en reaktion på et lægemiddel, der anvendes til at behandle din sygdom.
English: Week 2 (for boxes of 14, 28 and 84 tablets) Week 3 (for boxes of 28 and 84 tablets) Week 4 (for boxes of 28 and 84 tablets)
Danish: Uge 2 (for pakninger med 14, 28 og 84 tabletter) Uge 3 (for pakninger med 28 og 84 tabletter) Uge 4 (for pakninger med 28 og 84 tabletter)
English: Marketing Authorisation Holder: Zentiva k.s.
Danish: Indehaver af markedsføringstilladelsen: Zentiva k.s.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Contact your doctor or pharmacist before stopping.
Danish: Kontakt din læge eller apoteket, før du stopper.
English: For the 7, 14, 28 and 84 tablets pack sizes, you can check the day on which you last took a tablet of Clopidogrel Zentiva by referring to the calendar printed on the blister.
Danish: For pakninger med 7, 14, 28 stk. og 84 stk. tabletter kan du tjekke på hvilken dag du sidst tog en tablet ved at se på kalenderen trykt på blisterpakningen.
English: The other ingredients are (see section 2 ‘Clopidogrel Zentiva contains lactose' and ‘Clopidogrel Zentiva contains hydrogenated castor oil'):
Danish: Øvrige indholdsstoffer (se afsnit 2 'Clopidogrel Zentiva indeholder lactose' og Clopidogrel Zentiva indeholder hydrogeneret ricinusolie')
English: It is unknown whether clopidogrel is excreted in human breast milk.
Danish: Det vides ikke, om clopidogrel udskilles i human mælk hos mennesker.
English: Zentiva Pharma UK Limited Tel: +44 (0) 845 372 7101
Danish: United Kingdom Zentiva Pharma UK Limited Tel: +44 (0) 845 372 7101
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 2 or section 6.1.
Danish: • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt 2
English: You should take Clopidogrel Zentiva for as long as your doctor continues to prescribe it.
Danish: Du skal fortsætte med at tage Clopidogrel Zentiva, så længe din læge udskriver det til dig.
English: You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Clopidogrel Zentiva and acetylsalicylic acid for this condition.
Danish: Du bør være blevet informeret om, at ”orale antikoagulantia” er mere effektive mod denne sygdom end acetylsalicylsyre eller kombinationen af Clopidogrel Zentiva og acetylsalicylsyre.
English: For patients who did not undergo angiography, the primary endpoint was death or recurrent myocardial infarction by Day 8 or by hospital discharge.
Danish: For de patienter der ikke gennemgik angiografi, var det primære endepunkt død, gentaget MI ved dag 8 eller ved udskrivelse fra hospitalet.
English: If you forget to take a dose of Clopidogrel Zentiva, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Danish: Hvis du glemmer at tage en dosis Clopidogrel Zentiva til sædvanlig tid, men kommer i tanke om det i løbet af 12 timer, skal du omgående tage tabletten og dernæst tage den næste tablet til sædvanlig tid.
English: This benefit was mostly driven by the statistically significant reduction in the incidence of MI [287 (4.6%) in the clopidogrel treated group and 363 (5.8%) in the placebo treated group].
Danish: Fordelen må hovedsageligt tilskrives den statistisk signifikante reduktion i forekomsten af MI [287 (4,6 %) i clopidogrelgruppen og 363 (5,8 %) i placebogruppen].
English: The results obtained in populations with different characteristics (e.g. unstable angina or non-Q-wave MI, low to high risk levels, diabetes, need for revascularisation, age, gender, etc.) were consistent with the results of the primary analysis.
Danish: De resultater, som blev opnået i populationer med forskellige karakteristika (fx ustabil angina pectoris eller MI uden forekomst af Q-takker, høj- eller lavrisikogruppe, diabetes, behov for revaskularisering, alder, køn, osv.) svarede til den primære analyses resultater.
English: Store below 30°C (for PVC/PVDC/aluminium blisters) Or No special storage conditions (for all aluminium blisters)
Danish: Opbevares ved temperatuer under 30 ºC (for PVC/PVDC/aluminium blister) Eller ingen særlige opbevaringsbetingelser (for blisterkort i ren aluminium)
English: If you forget to take Clopidogrel Zentiva
Danish: Hvis du har glemt at tage Clopidogrel Zentiva
English: In patients with acute ST-segment elevation MI, safety and efficacy of clopidogrel have been evaluated in 2 randomised, placebo-controlled, double-blind studies, CLARITY and COMMIT.
Danish: Hos patienter med AMI med ST-segment elevation blev sikkerheden ved og effekten af clopidrogrel vurderet i 2 randomiserede, placebo-kontrollerede, dobbeltblindede undersøgelser kaldet CLARITY og COMMIT.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om Clopidogrel Zentiva, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: If you stop taking Clopidogrel Zentiva Do not stop the treatment unless your doctor tells you so.
Danish: Hvis du holder op med at tage Clopidogrel Zentiva Du må ikke ophøre med behandlingen medmindre din læge fortæller dig, at du skal gøre det.
English: As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel Zentiva.
Danish: Som forholdsregel bør amning ophøre under behandling med Clopidogrel Zentiva.
English: Your doctor should have prescribed Clopidogrel Zentiva plus acetylsalicylic acid if you cannot take ‘oral anticoagulants' and you do not have a risk of major bleeding.
Danish: Din læge bør have udskrevet Clopidogrel Zentiva plus acetylsalicylsyre hvis du ikke må tage ”orale antikoagulantia” og du ikke har en risiko for alvorlig blødning.
English: Although the administration of clopidogrel 75 mg/day did not modify the pharmacokinetics of S-warfarin or International Normalised Ratio (INR) in patients receiving long-term warfarin therapy, coadministration of clopidogrel with warfarin increases the risk of bleeding because of independent effects on hemostasis.
Danish: Selvom administration af 75 mg clopidogrel dagligt ikke ændrede S-warfarins farmakokinetik eller International Normalised Ratio (INR) hos patienter i langtidsbehandling med warfarin, øgede samtidig administration af clopidogrel og warfarin blødningsrisikoen på grund af uafhængig effekt på hæmostasen.
English: - ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
Danish: - akut myokardieinfarkt (AMI) med elevation af ST-segmentet i kombination med ASA hos medicinsk behandlede patienter, der er egnede til trombolytisk behandling.
English: Thrombolytics: the safety of the concomitant administration of clopidogrel, fibrin or non-fibrin specific thrombolytic agents and heparins was assessed in patients with acute myocardial infarction.
Danish: Trombolytika: Sikkerheden ved samtidig administration af clopidogrel, fibrin eller nonfibrinspecifikke trombolytiske midler og hepariner blev bedømt hos patienter med AMI.
English: Tests are available to identify a patient's CYP2C19 genotype.
Danish: Test er tilgængelige til at identificere en patients CYP2C19 genotype.
English: In TRITON-TIMI 38 and 3 of the cohort studies (Collet, Sibbing, Giusti) the combined group of patients with either intermediate or poor metaboliser status had a higher rate of cardiovascular events (death, myocardial infarction, and stroke) or stent thrombosis compared to extensive metabolisers.
Danish: I TRITON-TIMI 38 og 3 af kohortestudierne (Collet, Sibbing, Giusti) havde den kombinerede gruppe af patienter med status som enten intermediate eller poor metabolisers en højere hyppighed af kardiovaskulære hændelser (død, MI og apopleksi) eller stenttrombose sammenlignet med extensive metabolisers.
English: Their frequency is defined using the following conventions: common
Danish: Hyppighed defineres i henhold til følgende konvention: almindelig (>1/100 til
English: If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Zentiva:
Danish: Hvis nogen af følgende situationer gælder for dig, skal du oplyse det til din læge, før du tager Clopidogrel Zentiva:
English: Clopidogrel significantly reduced the incidence of new ischaemic events (combined end point of myocardial infarction, ischaemic stroke and vascular death) when compared to ASA.
Danish: Clopidogrel reducerede signifikant forekomsten af nye iskæmiske tilfælde (kombineret endepunkt, der omfattede MI, iskæmisk apopleksi og vaskulær død) ved sammenligning med ASA.
English: If you become pregnant while taking Clopidogrel Zentiva, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Danish: Hvis du bliver gravid, mens du tager Clopidogrel Zentiva, skal du omgående kontakte din læge, da det frarådes at tage Clopidogrel Zentiva under graviditet.
English: In patients who were enrolled in the trial on the sole basis of a recent myocardial infarction, clopidogrel was numerically inferior, but not statistically different from ASA (RRR = -4.0%; CI: -22.5 to 11.7 [p=0.639]).
Danish: Hos de patienter, som alene indgik i studiet på grund af et nyligt MI, lå clopidogrel numerisk lavere, men ikke statistisk forskelligt fra ASA (RRR = 4,0 %, CI: -22,5 til 11,7 [p=0,639]).