FrancophonIA/ELRC3.0 huggingface dataset:
English: Abdominal pain may be a symptom of the above listed complications.
Danish: Abdominalsmerter kan være et symptom på de ovenfor anførte komplikationer.
English: (Applicable to bosutinib and ponatinib)
Danish: (Gældende for bosutinib og ponatinib)
English: Adverse Reaction Data Derived From Clinical Trials and Postmarketing Experience Uncommon (> 1/1,000 to < 1/100)
Danish: Bivirkninger baseret på data fra kliniske forsøg og erfaringer efter markedsføring Ikke almindelig (>1/1 000 til <1/100)
English: • Food getting stuck around the tube causing it to block.
Danish: • Fødevarer sætter sig fast omkring sonden, så den blokeres.
English: Intussusception has also been reported post marketing.
Danish: Intussusception er desuden indberettet efter markedsføring.
English: • Blockage (obstruction), bleeding or ulcer in the gut.
Danish: • Blokering (obstruktion), blødning eller sår i tarmen.
English: (Applicable to imatinib, dasatinib and nilotinib)
Danish: (Gældende for imatinib, dasatinib og nilotinib)
English: • Inflamed colon (colitis).
Danish: • Tyktarmsbetændelse (colitis).
English: Most bezoars reside in the stomach but bezoars may be encountered elsewhere in the intestinal tract.
Danish: De fleste bezoarer findes i mavesækken, men de kan også ses andre steder i mave-tarmkanalen.
English: DUODOPA (levodopa/carbidopa - intestinal gel)Intussusception (EPITT no 18424)
Danish: DUODOPA (levodopa/carbidopa - enteralgel)Intussusception (EPITT nr. 18424)
English: Some events may result in serious outcomes, such as surgery and/or death.
Danish: Nogle bivirkninger kan have alvorlige følgevirkninger, f.eks. operation og/eller død.
English: A bezoar around the tip of the jejunal tube may function as a lead point for intestinal obstruction or the formation of intussusception.
Danish: Et bezoar omkring spidsen af den jejunale sonde kan udløse tarmobstruktion eller dannelse af intussusception.
English: • Inflamed pancreas (pancreatitis).
Danish: • Betændelse i bugspytkirtlen (pankreatitis).
English: Premenopausal women: Ovarian macrocysts have been observed with higher incidence in this population.
Danish: Præmenopausale kvinder: Øget forekomst af makrocyster i ovarierne er set hos denne gruppe.
English: Patients should be advised to notify their physician if they experience any of the symptoms associated with the above events.
Danish: Patienterne skal informeres om at kontakte deres læge, hvis de oplever symptomer på nogle af de ovennævnte bivirkninger."
English: Bezoars are retained concretions of undigested food indigestible material (such as vegetable or fruit non-digestible fibers) in the intestinal tract.
Danish: Bezoarer er tilbageholdte konkrementer af ufordøjet mad ufordøjeligt materiale (såsom ufordøjelige fibre fra grønsager og frugt) i mave-tarmkanalen.
English: Bcr-abl tyrosine kinase inhibitors: GLIVEC (imatinib); SPRYCEL (dasatinib); TASIGNA (nilotinib); BOSULIF (bosutinib); ICLUSIG (ponatinib) - Hepatitis B virus (HBV) reactivation (EPITT no 18405)
Danish: BCR-ABL-tyrosinkinasehæmmere: GLIVEC (imatinib), SPRYCEL (dasatinib), TASIGNA (nilotinib), BOSULIF (bosutinib), ICLUSIG (ponatinib) - reaktivering af hepatitis B-virus (HBV) (EPITT nr. 18405)
English: - If you have gynaecological problems such as bleeding and/or pelvic pain.
Danish: - Hvis du har underlivsproblemer som blødning og/eller smerter.
English: Patients will be carefully checked by their doctor for signs of this infection before treatment is started.
Danish: Patienten skal omhyggeligt kontrolleres af lægen for tegn på denne type smitte, før behandlingen påbegyndes.
English: • Sliding of one part of the gut into an adjacent part of the gut (intussusception)
Danish: • En del af tarmen skyder sig ind i en nærliggende del af tarmen (intussusception)
English: Women should be urged to seek medical advice if they experience gynecological symptoms such as bleeding and/or pelvic pain.
Danish: Kvinden skal informeres om at søge læge i tilfælde af gynækologiske symptomer såsom blødning og/eller underlivssmerter.
English: Intussusception
Danish: Mave-tarmkanalen Intussusception
English: Reported complications in the clinical studies, and seen post-marketing, include bezoar, ileus, implant site erosion/ulcer, intestinal haemorrhage, intestinal ischaemia, intestinal obstruction, intestinal perforation, intussusception, pancreatitis, peritonitis, pneumoperitoneum and post-operative wound infection.
Danish: "Komplikationer, der er beskrevet i kliniske studier og iagttaget efter markedsføring, omfatter bezoar, ileus, erosion/ulcus på administationsstedet, intestinal blødning, intestinal iskæmi, tarmobstruktion, tarmperforation, intussusception, pankreatitis, peritonitis, pneumoperitoneum og postoperativ sårinfektion.
English: • Pocket of infection (abscess) - this could happen after the tube is placed in your stomach
Danish: • Byld med betændelse (absces) - kan opstå, efter at sonden er placeret i mavesækken.
English: LYSODREN (mitotane) - Sex hormone disturbances and development of ovarian macrocysts (EPITT no 18301)
Danish: LYSODREN (mitotan) - Kønshormonforstyrrelser og udvikling af æggestokcyster (makrocyster i ovarierne) (EPITT nr. 18301)
English: This is because BRANDNAME DRUG could cause hepatitis B to become active again, which can be fatal in some cases.
Danish: Dette skyldes, at (lægemidlets særnavn) kan forårsage, at hepatitis B-infektionen bliver aktiv igen, hvilket undertiden kan være dødeligt.
English: Patients should be tested for HBV infection before initiating treatment with (BRANDNAME DRUG).
Danish: Patienten bør testes for HBV-infektion før initiering af behandlingen med (lægemidlets særnavn).
English: Talk to your doctor, pharmacist or nurse before taking BRANDNAME DRUG
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager (lægemidlets særnavn),
English: Possible side effects - Recurrence (reactivation) of Hepatitis B infection when you have had hepatitis B in the past (a liver infection).
Danish: Bivirkninger - Genopblussen (reaktivering) af hepatitis B-infektion, hvis du tidligere har haft hepatitis B (leverbetændelse type B).
English: Carriers of HBV who require treatment with BRANDNAME DRUG should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8).
Danish: Bærere af HBV, hvor behandling med (lægemidlets særnavn) er nødvendig, skal overvåges tæt for tegn og symptomer på aktiv HBV-infektion i hele behandlingsperioden og i flere måneder efter behandlingsophør (se pkt.
English: Table 1 Tabulated summary of adverse reactions Infections and infestations
Danish: Tabel 1 Tabel over bivirkninger
English: Frequency not known - Ovarian macrocysts (with symptoms such as pelvic pain, bleeding) - Decreased androstenedione (precursor of sex hormones) in blood tests in females - Decreased testosterone (sex hormone) in blood tests in females - Sex hormone binding globulin (a protein which binds sex hormones) increased in blood tests - Decreased free testosterone (sex hormone) in blood tests in males
Danish: Hyppighed ikke kendt - Cyster på æggestokkene (med symptomer som underlivssmerter og blødning) - Nedsat androstendion (forstadium til kønshormoner) i blodprøver hos kvinder - Nedsat testosteron (kønshormon) i blodprøver hos kvinder - Forhøjet kønshormonbindende globulin (protein, der binder kønshormoner) i blodprøver - Nedsat frit testosteron (kønshormon) i blodprøver hos mænd
English: Frequency ‘not known': Hepatitis B reactivation
Danish: Hyppighed "Ikke kendt": Reaktivering af hepatitis B Beskrivelse af udvalgte bivirkninger:
English: • The tube goes through the wall of the large intestine.
Danish: • Sonden trænger igennem tyktarmsvæggen.
English: What you need to know before you take BRANDNAME DRUG
Danish: Det skal du vide, før du begynder at tage (lægemidlets særnavn)
English: What you need to know before you take BRANDNAME DRUG Talk to your doctor, pharmacist or nurse before taking BRANDNAME DRUG - if you have ever had or might now have a hepatitis B infection.
Danish: Det skal du vide, før du begynder at tage (lægemidlets særnavn) Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager (lægemidlets særnavn), - hvis du nogensinde har været eller måske er smittet med hepatitis B. Dette er fordi (lægemidlets særnavn) kan forårsage, at hepatitis B bliver aktiv igen, hvilket undertiden kan være dødeligt.
English: Uncommon: may affect up to 1 in 100 people
Danish: Bivirkninger forårsaget af pumpen eller sonden Ikke almindelig (kan forekomme hos op til 1 ud af 100 patienter)
English: Side effects from the pump or tube
Danish: Bivirkninger forårsaget af udstyr eller procedurer
English: 4.8 Undesirable effects SOC: Investigations (frequency not known): - Blood androstenedione decreased (in females) - Blood testosterone decreased (in females) - Sex hormone binding globulin increased - Blood free testosterone decreased (in males) SOC: Reproductive system and breast disorders (frequency not known): - Ovarian macrocysts Premenopausal women: non-malignant ovarian macrocysts (with symptoms such as pelvic pain, bleeding) have been described.
Danish: Systemorganklasse: Undersøgelser (hyppighed ikke kendt): - Nedsat androstendion i blodet (hos kvinder) - Nedsat testosteron i blodet (hos kvinder) - Forhøjet kønshormonbindende globulin - Nedsat frit testosteron i blodet (hos mænd)
English: The European Commission issued a decision on 20 January 2012.
Danish: Europa-Kommissionen traf sin afgørelse den 20. januar 2012.
English: convulsions.
Danish: kramper.
English: They are currently marketed in Belgium, France, Luxembourg, Finland, Italy, Portugal and Spain under various trade names.
Danish: På nuværende tidspunkt markedsføres de i Belgien, Frankrig, Luxembourg, Finland, Italien, Portugal og Spanien under forskellige handelsnavne.
English: What are the recommendations for patients and carers?
Danish: Hvilke anbefalinger gives der til patienter og omsorgsgivere?
English: 11 April 2012 EMA/CHMP/763180/2011 Corr to Rev 1
Danish: 11. april 2012 EMA/CHMP/763180/2011 Korr til rev 1
English: They include camphor, cineole, terpineol, terpine, citral and menthol.
Danish: De omfatter kamfer, cineol, terpinol, terpin, citral og mentol.
English: • Patients and carers who have any questions should speak to their doctor or pharmacist.
Danish: • Patienter og omsorgsgiveren, der ønsker yderligere oplysninger, bør henvende sig til lægen eller apotekspersonalet.
English: Questions and answers on the review of suppositories containing terpenic derivatives
Danish: Spørgsmål og svar om revurderingen af suppositorier indeholdende terpenderivater
English: It also decided that there was a risk of these medicines causing local anorectal lesions.
Danish: Udvalget fandt desuden, at der er risiko for, at disse lægemidler medfører lokale anorektale læsioner.
English: The approved indications vary in different EU countries, but typically include supportive treatment for mild, sudden bronchial disorders, particularly productive and non-productive cough.
Danish: De godkendte indikationer er forskellige i de forskellige EU-lande, men består typisk i behandling af milde akutte bronkiale lidelser, navnlig produktiv og ikke-produktiv hoste.
English: Questions and answers on the review of suppositories containing terpenic derivatives EMA/CHMP/763180/2011 Corr to Rev 1
Danish: Spørgsmål og svar om revurderingen af suppositorier indeholdende terpenderivater EMA/CHMP/763180/2011 Korr∗ til rev 1
English: The medicines concerned by this review are used to treat coughs and colds in children and adolescents.
Danish: Lægemidlerne i denne gennemgang er til behandling af hoste og forkølelse hos børn og unge.
English: Consequently, on 27 October 2010 the French agency asked the CHMP to carry out a full assessment of the benefit-risk balance of suppositories containing terpenic derivatives in children younger than 30 months of age and to issue an opinion on whether the marketing authorisations for these medicines should be maintained, varied, suspended or withdrawn across the EU in this population.
Danish: Som følge heraf anmodede den franske lægemiddelstyrelse den 27. oktober 2010 CHMP om at foretage en fuldstændig vurdering af benefit/risk-forholdet for suppositorier indeholdende terpenderivater hos børn under 30 måneder og at fremsætte en udtalelse om, hvorvidt markedsføringstilladelserne for disse lægemidler bør opretholdes, ændres, suspenderes eller inddrages i hele EU for denne population.
English: • Terpenic derivatives in other forms, such as solutions to be inhaled or rubbed into the skin, may continue to be used as currently approved.
Danish: • Terpenderivater i andre former, således opløsninger, der inhaleres eller gnides ind i huden, kan fortsat anvendes i overensstemmelse med den nuværende godkendelse.
English: The CHMP looked at the benefit-risk assessment carried out by France, and information requested from the companies that market suppositories containing terpenic derivatives in the EU.
Danish: CHMP gennemgik den benefit/risk-vurdering, der var foretaget af Frankrig, og de oplysninger, der var blevet anmodet om fra de virksomheder, der markedsfører suppositorier indeholdende terpenderivater i EU.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that there was a risk of these medicines inducing neurological disorders, especially convulsions, in infants and small children.
Danish: Efter vurderingen af de aktuelt foreliggende data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at der er risiko for, at disse lægemidler medfører neurologiske symptomer, navnlig kramper, hos spædbørn og mindre børn.
English: The CHMP noted that children aged up to 30 months and children with a history of epilepsy or febrile convulsion were most at risk of these neurological side effects because their nervous system is not yet fully developed.
Danish: CHMP bemærkede, at børn op til 30 måneder og børn med epilepsi eller febrile kramper i anamnesen er mest udsat for at få disse neurologiske bivirkninger, da deres nervesystem endnu ikke er fuldt udviklet.
English: They are also found in essential oils obtained from plants, such as niaouli, wild thyme or eucalyptus.
Danish: De findes desuden i æteriske olier fra planter såsom niaouli, vild timian og eukalyptus.
English: The French medicines regulatory agency had concerns about the safety of suppositories containing terpenic derivatives, particularly the risk of serious neurological side effects in young children such as
Danish: Den franske lægemiddelstyrelse havde betænkeligheder ved sikkerheden af suppositorier indeholdende terpenderivater, navnlig risikoen for alvorlige neurologiske bivirkninger hos mindre børn, såsom
English: This included study data supporting the marketing authorisations and safety data including reports of side effects from post-marketing surveillance and the published literature.
Danish: Disse oplysninger bestod i data fra de undersøgelser, der havde dannet grundlag for markedsføringstilladelserne, og sikkerhedsdata i form af bivirkningsindberetninger fra overvågning efter markedsføring og fra litteraturen.
English: The French agency was also concerned that reliable data on the effectiveness of these medicines were not available, and that the medicines did not fulfil the latest clinical recommendations for treating cough in children.
Danish: Den franske lægemiddelstyrelse havde desuden betænkelighed ved, at der ikke foreligger pålidelige data om effektiviteten af disse lægemidler, og at lægemidlerne ikke er i overensstemmelse med de nyeste kliniske anbefalinger for behandling af hoste hos børn.
English: Terpenic derivatives are mainly obtained from natural substances originating from plants such as conifers.
Danish: Terpenderivater udvindes hovedsagelig af naturstoffer fra koglebærende planter.
English: The Committee noted that the effectiveness of these medicines had not been clearly demonstrated, as no clinical trials with suppositories containing terpenic derivatives had been performed and there were no studies focused on infants and children.
Danish: Udvalget bemærkede, at effektiviteten af disse lægemidler ikke er klart påvist, idet der ikke er udført kliniske undersøgelser med suppositorier indeholdende terpenderivater, og idet der ikke foreligger undersøgelser rettet mod spædbørn og mindre børn.
English: In the EU, suppositories containing terpenic derivatives are authorised by national procedures and are available without prescription.
Danish: I EU er suppositorier indeholdende terpenderivater godkendt gennem nationale procedurer og fås uden recept.
English: Medicines containing terpenic derivatives are available in various forms, including solutions to be inhaled or rubbed into the skin as well as suppositories.
Danish: Lægemidler indeholdende terpenderivater findes i forskellige former, herunder som opløsninger, der inhaleres eller gnides ind i huden, og som suppositorier.
English: The European Medicines Agency has completed a review of the safety and effectiveness of suppositories containing terpenic derivatives.
Danish: Det Europæiske Lægemiddelagentur har revurderet sikkerheden og virkningen af suppositorier indeholdende terpenderivater.
English: Suppositories containing terpenic derivatives are medicines given rectally used to treat various conditions.
Danish: Suppositorier indeholdende terpenderivater er lægemidler, der gives rektalt til behandling af forskellige tilstande.
English: Why were suppositories containing terpenic derivatives reviewed?
Danish: Hvorfor blev suppositorier indeholdende terpenderivater undersøgt?
English: They are often found in herbal substances and herbal preparations, such as pine needle or turpentine.
Danish: De findes ofte i plantestoffer og plantepræparater som f.eks. fyrrenåle og terpentin.
English:  Editorial revisions have been made in the description of terpenic derivatives to ensure accuracy.
Danish: ∗ Der er foretaget redaktionelle ændringer for at gøre beskrivelsen af terpenderivater mere nøjagtig.
English: What are suppositories containing terpenic derivatives?
Danish: Hvad er suppositorier indeholdende terpenderivater?
English: • Suppositories containing terpenic derivatives should not be used in children under 30 months old, children with a history of epilepsy or febrile convulsion and children with a recent history of anorectal lesion.
Danish: • Suppositorier indeholdende terpenderivater bør ikke anvendes hos børn under 30 måneder, børn med tidligere epilepsi eller febrile kramper og børn med nylig anorektal læsion i anamnesen.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the use of these medicines should be contraindicated in children under 30 months old, children with a history of epilepsy or febrile convulsion and children with a recent history of anorectal lesion (precancerous growths in the anus or rectum).
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at sådanne lægemidler bør være kontraindiceret til børn under 30 måneder, børn med tidligere epilepsi eller febrile kramper og børn med nylig anorektal læsion (prækankrøse forandringer i anus eller rektum) i anamnesen.
English: The Committee therefore recommended that the use of suppositories containing terpenic derivatives be contraindicated in children under 30 months old, children with a history of epilepsy or febrile convulsion and children with a recent history of anorectal lesion.
Danish: Udvalget anbefalede derfor, at anvendelsen af suppositorier indeholdende terpenderivater gøres kontraindiceret hos børn under 30 måneder, børn med tidligere epilepsi eller febrile kramper og børn med nylig anorektal læsion i anamnesen.
English: Treatment should be started by a doctor who has experience in the management of HIV infection.
Danish: Behandlingen bør indledes af en læge med erfaring i behandling af HIV-infektion.
English: It is only used in patients who have responded well to their current HIV treatment and who do not have an HIV infection that is resistant to treatment or not likely to respond to one of the active substances in the medicine.
Danish: Det anvendes kun til patienter, som har reageret godt på deres nuværende HIV-behandling, og som ikke har en HIV-infektion, der er modstandsdygtig over for behandling eller sandsynligvis ikke vil reagere på et af de aktive stoffer i lægemidlet.
English: It is recommended that the medicine be taken on an empty stomach, preferably at bedtime.
Danish: Det anbefales, at lægemidlet tages på tom mave og helst ved sengetid.
English: The recommended dose is one tablet daily, swallowed whole with water.
Danish: Den anbefalede dosis er én tablet, der synkes hel sammen med vand, én gang dagligt.
English: It does not cure HIV infection or AIDS, but it may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Det helbreder ikke HIV-infektion eller AIDS, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med AIDS.
English: Patients should take the medicine regularly and avoid missing doses.
Danish: Patienterne skal tage lægemidlet regelmæssigt og undgå at springe over doser.
English: This means that it contains the same active substances and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Atripla.
Danish: Det betyder, at det indeholder de samme aktive stoffer og virker på samme måde som et "referencelægemiddel" kaldet Atripla, der allerede er godkendt i Den Europæiske Union (EU).
English: All three active substances block the activity of reverse transcriptase, an enzyme produced by HIV that allows it to reproduce itself in the cells it has infected.
Danish: Alle tre aktive stoffer blokerer aktiviteten af revers transkriptase, der er et enzym, som HIV producerer, så det kan formere sig i de celler, det har inficeret.
English: The educational pack also contains recommendations for monitoring kidney function in patients taking the medicine.
Danish: Informationspakken vil også indeholde anbefalinger om overvågning af nyrefunktionen hos patienter, der tager lægemidlet.
English: Both nucleoside and nucleotide reverse transcriptase inhibitors are commonly known as NRTIs.
Danish: Både nukleoside og nukleotide reverse transkriptasehæmmere betegnes almindeligvis som NRTI'er.
English: Therefore, the Agency's view was that, as for Atripla, the benefit outweighs the identified risk.
Danish: Agenturet var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for Atripla.
English: The full EPAR can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Atripla, and do not need to be repeated for Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva.
Danish: Der er allerede gennemført undersøgelser af fordelene og risiciene ved de aktive stoffer i den godkendte anvendelse med referencelægemidlet, Atripla, og det er ikke nødvendigt at gentage disse med Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva is a medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva er et lægemiddel til behandling af voksne, som er smittet med humant immundefektvirus-1 (HIV-1), en virus, der medfører erhvervet immundefektsyndrom (AIDS).
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva keeps the amount of HIV in the blood at a low level.
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva holder mængden af HIV i blodet på et lavt niveau.