FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP considered that the results from the main study comparing Opdivo and Yervoy with sunitinib showed a clinically important increase in patients' survival with the combination, and side effects were considered acceptable.
Danish: CHMP var af den opfattelse, at resultaterne fra hovedstudiet, hvori Opdivo og Yervoy blev sammenlignet med sunitinib, viste en klinisk vigtig forbedring i patienternes overlevelsestid med kombinationen, og bivirkningerne blev anset for at være acceptable.
English: Opdivo and Yervoy are to be used together in patients with previously untreated advanced renal cell carcinoma that is considered to be of moderate or high risk of worsening.
Danish: Opdivo og Yervoy skal anvendes sammen til patienter, der ikke tidligere er blevet behandlet for fremskredent renalcellekarcinom, og som har en moderat til høj risiko for, at kræften hurtigt forværres.
English: The study compared treatment with Opdivo and Yervoy versus treatment with another cancer medicine, sunitinib.
Danish: I studiet blev behandlingen med Opdivo og Yervoy sammenlignet med behandlingen med et andet lægemiddel, sunitinib.
English: On 26 July 2018, the CHMP had originally adopted a negative opinion for the use of Opdivo and Yervoy for the treatment of renal cell carcinoma.
Danish: Den 26. juli 2018 vedtog CHMP en negativ udtalelse om anvendelsen af Opdivo og Yervoy til behandling af nyrecellekarcinom.
English: It is known that Opdivo alone produces benefit in previously treated patients with renal cell carcinoma.
Danish: Det er et faktum, at Opdivo alene har en gavnlig virkning hos tidligere behandlede patienter med renalcellekarcinom.
English: What are Opdivo and Yervoy?
Danish: Hvad er Opdivo og Yervoy?
English: By blocking CTLA-4, ipilimumab causes activation and increase of T cells, which enter into tumours and kill the tumour cells.
Danish: Ved at blokere CTLA-4 aktiverer ipilimumab T-cellerne og får antallet af dem til at stige, hvorefter de trænger ind i tumorerne og slår tumorcellerne ihjel.
English: How do Opdivo and Yervoy work?
Danish: Hvordan virker Opdivo og Yervoy?
English: What are Opdivo and Yervoy to be used for?
Danish: Hvad forventedes Opdivo og Yervoy anvendt til?
English: By attaching to the receptor, nivolumab prevents PD-L1 and PD-L2 from switching off the T cells, thereby increasing the ability of the immune system to kill cancer cells.
Danish: Ved at binde sig til receptoren forhindrer nivolumab PD-L1 og PD-L2 i at afbryde T-cellerne.
English: Annex I List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states
Danish: Bilag I Fortegnelse over lægemidlernes navne, lægemiddelform(er), styrke(r), administrationsvej(e), indehaver(e) af markedsføringstilladelse(r) i medlemsstaterne
English: Hydergin SRO 6 mg Kapseln modified-release capsule, hard
Danish: Hydergin SRO 6 mg Kapseln modificeret udløsning, hårde
English: 4.5 mg (1:1:1) film-coated tablet
Danish: 4.5 mg (1:1:1) Filmovertrukket tablet
English: CAPERGYL 4,5 mg DOSE QUOTIDIENNE UNIQUE, capsule soft capsule
Danish: CAPERGYL 4,5 mg DOSE QUOTIDIENNE UNIQUE, capsule blød kapsel
English: LEK PHARMACEUTICALS d.d.
Danish: Rumænien LEK PHARMACEUTICALS d.d.
English: Verovskova 57, 1526 Ljubljana, Slovenia
Danish: 1526 Ljubljana, Slovenia
English: LEK farmacevtska družba d.d.,
Danish: Slovenien LEK farmacevtska družba d.d.,
English: Verovskova 57, SI-1526 Ljubljana, Slovenia
Danish: SI-1526 Ljubljana,
English: Hydergin 3 mg/ml Tropfen 3 mg/ml (1:1:1) oral drops, solution oral use
Danish: Hydergin 3 mg/ml Tropfen 3 mg/ml (1:1:1) orale dråber, opløsning
English: Hydergin 1 mg/ml Tropfen 1 mg/ml (1:1:1) oral drops, solution oral use
Danish: Hydergin 1 mg/ml Tropfen 1 mg/ml (1:1:1) orale dråber, opløsning
English: Belgium Defiante Farmacêutica S.A., Rua dos Ferreiros 260, 9000-082 Funchal, Portugal
Danish: Defiante Farmacêutica S.A., Rua dos Ferreiros 260, 9000-082 Funchal, Portugal
English: What is Septanest?
Danish: Hvad er Septanest?
English: It is given by injection.
Danish: Det gives ved indsprøjtning.
English: 27 May 2019
Danish: 27. maj 2019
English: Septanest has been authorised in the EU via national procedures.
Danish: Septanest er godkendt i EU via nationale procedurer.
English: It must also not be given to patients with epilepsy who are not adequately controlled by treatment.
Danish: Det må heller ikke gives til patienter med epilepsi, som ikke er tilstrækkeligt reguleret ved behandling.
English: Why was Septanest reviewed?
Danish: Hvorfor blev Septanest gennemgået på ny?
English: The package leaflet has been updated accordingly.
Danish: Indlægssedlen er blevet opdateret i overensstemmelse hermed.
English: The recommended dose of Septanest depends on the patient's body weight.
Danish: Den anbefalede Septanest-dosis afhænger af patientens legemsvægt.
English: After review of the available data, a number of other contraindications which were only valid in some countries were considered not to be supported by sufficient data or were considered redundant.
Danish: Efter gennemgangen af de tilgængelige data blev en række andre kontraindikationer, som kun gjaldt i nogle lande, anset for ikke at være understøttet af tilstrækkelige data eller for at være redundante.
English: A European Commission decision valid throughout the EU was issued on 27/05/2019.
Danish: Europa-Kommissionen vedtog en afgørelse med gyldighed i hele EU den 27. maj 2019.
English: The maximum recommended dose in all ages is 7 mg of articaine per kg body weight, up to a maximum total dose of 500 mg in adults and 385 mg in children.
Danish: Den anbefalede maksimale dosis i alle aldre er 7 mg articain pr. kg legemsvægt, op til en maksimal samlet dosis på 500 mg hos voksne og 385 mg hos børn.
English: In addition, parts of Module 3 of the medicine dossier (which describes how the medicine is produced and its quality controlled) have also been harmonised.
Danish: Derudover blev også dele af modul 3 i lægemidlets dossier (som beskriver, hvordan lægemidlet fremstilles, og hvordan dets kvalitet kontrolleres) harmoniseret.
English: Septanest is also available in the EU under other trade names including Septanest Forte, Septanest N, Septanest Normal, Septanest SP, Septanest Special, Septanest with Adrenaline, Septanestepi and Septocaine.
Danish: Septanest er også til rådighed i EU under andre handelsnavne, herunder Septanest Forte, Septanest N, Septanest Normal, Septanest SP, Septanest Special, Septanest med adrenalin, Septanestepi og Septocain.
English: Where justified by data, some of the previous contraindications have been included in section 4.4 (special warnings and precautions for use).
Danish: I de tilfælde, hvor de understøttes af data, er nogle af de tidligere kontraindikationer medtaget i punkt 4.4 (særlige advarsler og forsigtighedsregler vedrørende brugen).
English: Septanest contains the active ingredient articaine together with adrenaline (epinephrine), which helps prolong articaine's effects and restrict it to a particular area of the body.
Danish: Septanest indeholder det aktive stof articain sammen med adrenalin (epinephrin), som hjælper med at forlænge articains virkninger og begrænse det til et bestemt område af kroppen.
English: After considering the available data on the use of Septanest, the Agency concluded that the SmPC should be harmonised.
Danish: Efter at have gennemgået de tilgængelige data vedrørende brugen af Septanest konkluderede agenturet, at produktresuméet bør harmoniseres.
English: This has led to inconsistency across Member States in the way the medicine is produced and can be used, as seen in the differences in the prescribing information - that is, the summary of product characteristics (SmPC), labelling and package leaflet - in the countries where the medicine is marketed.
Danish: Dette har medført forskelle mellem medlemsstaterne i den måde, lægemidlet fremstilles og anvendes på, hvilket fremgår af ordinationsoplysningerne, dvs. produktresuméet, etiketteringen og indlægssedlen, i de lande, hvor lægemidlet markedsføres.
English: Other harmonised sections of the SmPC include section 4.4 (special warnings and precautions for use), 4.5 (interactions), 4.6 (fertility, pregnancy and lactation), 4.7 (effects on ability to drive and use machines), 4.8 (side effects), and 4.9 (overdose).
Danish: Andre afsnit i produktresuméet blev også harmoniseret, herunder punkt 4.4 (særlige advarsler og forsigtighedsregler vedrørende brugen), punkt 4.5 (interaktioner), punkt 4.6 (fertilitet, graviditet og amning), punkt 4.7 (virkning på evnen til at føre motorkøretøj og betjene maskiner), punkt 4.8 (bivirkninger) og punkt 4.9 (overdosis).
English: On 4 June 2018, Septodont, the company that markets Septanest, referred the matter to EMA in order to harmonise the marketing authorisations for Septanest in the EU.
Danish: Den 4. juni 2018 indbragte Septodont, som markedsfører Septanest, sagen for EMA med henblik på at harmonisere markedsføringstilladelserne for Septanest i EU.
English: On 28 March 2019, the European Medicines Agency (EMA) completed a review of Septanest (also known by various other names) and recommended changes to the prescribing information in order to harmonise the way the medicine is used in the EU.
Danish: Den 28. marts 2019 afsluttede Det Europæiske Lægemiddelagentur (EMA) en gennemgang af Septanest og relaterede navne og anbefalede ændringer i ordinationsoplysningerne med henblik på at harmonisere den måde, som lægemidlet anvendes på i EU.
English: Septanest is now authorised for use as a local anaesthetic in dental procedures in adults, adolescents and children above 4 years of age (or weighing at least 20 kg).
Danish: Septanest er nu godkendt til brug som lokalbedøvende middel ved dentale indgreb hos voksne, unge og børn over 4 år (eller med en legemsvægt på mindst 20 kg).
English: The review of Septanest was initiated on 29 June 2018 at the request of the marketing authorisation holder, Septodont, under Article 30 of Directive 2001/83/EC.
Danish: Gennemgangen af Septanest blev indledt på anmodning fra indehaveren af markedsføringstilladelsen, Septodont, i henhold til artikel 30 i direktiv 2001/83/EF.
English: Septanest must not be used in patients who are allergic to articaine or similar local anaesthetics (known as amide-type local anaesthetics) or to any other ingredient of the medicine.
Danish: Septanest må ikke anvendes til patienter, der er allergiske over for articain eller lignende lokalbedøvende midler (kendt som lokalbedøvende midler af amidtypen) eller et eller flere af de andre indholdsstoffer i lægemidlet.
English: Septanest is a local anaesthetic (a medicine for preventing pain and discomfort in a part of the body during medical procedures).
Danish: Septanest er et lokalt virkende bedøvelsesmiddel, der anvendes til at forebygge smerte og ubehag i en del af kroppen under medicinske indgreb.
English: • Take with or without food
Danish: • Kan tages med eller uden mad
English: Adults including the elderly
Danish: Voksne inklusive ældre
English: Prazosin, and you suffered an allergic reaction
Danish: Prazosin, og De har fået en allergisk reaktion
English: This should be considered when interpreting laboratory data.
Danish: Dette bør tages i betragtning, når laboratoriedata fortolkes.
English: This is more likely at the start of treatment or if the doctor increases your dose.
Danish: Det er mere sandsynligt ved starten af behandlingen , eller hvis Deres læge øger Deres dosis.
English: Your doctor has decided which dose is best for you.
Danish: Deres læge har bestemt, hvilken dosis der er bedst til Dem.
English: • other medicine to lower blood pressure
Danish: • Andre lægemidler til at sænke blodtrykket
English: Close control of blood pressure.
Danish: Nøje kontrol af blodtrykket.
English: In hypertensive patients both conditions are treated concomitantly.
Danish: Hos hypertensive patienter behandles begge tilstande samtidigt.
English: Follow your doctor's instructions and do not change the dose yourself.
Danish: Følg Deres læges henvisninger og lad være med selv at ændre dosis.
English: If it is almost time for your next dose though, do not double the dose just carry on as before.
Danish: Hvis det næsten er tid til den næste dosis, så lad være at tage en dobbeltdosis, men fortsæt som før.
English: Do not drive or operate machinery if you feel less alert while taking this medicine.
Danish: Lad være med at køre eller betjene maskineri, hvis De føler dem mindre opmærksom, mens De tager denne medicin.
English: The adverse reactions considered at least possibly related to treatment are listed below by body system organ class and absolute frequency.
Danish: Bivirkningerne, der betragtes som mindst muligvis relateret til behandlingen, er angivet nedenfor efter legemets organklassesystem og absolutte hyppighed.
English: Very rare: increase of serum creatinine.
Danish: Meget sjælden: Stigning i serum creatinin.
English: Tell your doctor if any of the above apply to you.
Danish: Fortæl det til Deres læge, hvis noget af ovenstående gælder for dem.
English: Ask your pharmacist how to dispose of medicines no longer required.
Danish: Spørg Deres apotek, hvad de skal gøre ved medicin, der ikke længere er nødvendig.
English: • Swallow the tablets whole with a full glass of water
Danish: • Synk tabletterne hele med et helt glas vand
English: If necessary, your doctor may increase this dose to the maximum of two tablets once a day.
Danish: Om nødvendigt kan Deres læge øge denne dosis til den maksimale på to tabletter én gang om dagen
English: Tell your doctor if you are already taking any of the following:
Danish: Fortæl det til Deres læge, hvis De allerede tager noget af følgende:
English: A dosage regime of 82mg/kg/day (8 times the human exposure) was associated with reduced foetal survival.
Danish: Et dosisregime på 82 mg/kg/dag (8 gange den humane eksponering) var forbundet med nedsat føtal overlevelse.
English: The tablets must be swallowed whole with a sufficient amount of liquid.
Danish: Tabletterne skal sluges hele med en tilstrækkelig mængde væske.
English: • medicine containing Estrogen
Danish: • Medicin, der indeholder østrogen
English: Very rare effects seen in less than 1 in 10,000 patients include blood changes and an increase in blood and creatinine levels.
Danish: Meget sjældne bivirkninger ses hos mindre end 1 ud af 10.000 patienter omfatter ændringer i blodet og en stigning i blod- og creatininniveauer.
English: They should be informed about the potential risk form injuries and measures of precaution to minimize orthostatic symptoms.
Danish: De bør oplyses om den mulige risiko for skader og forsigtighedstiltag for at minimere ortostatiske symptomer.
English: • if you have heart disease or a heart condition
Danish: • hvis De har en hjertesygdom eller en hjertetilstand
English: Trough levels at 24 hours are, however, similar.
Danish: Bølgedalsniveauer ved 24 timer er imidlertid de samme for begge formuleringer.
English: Radioactivity was found to cross the placenta following oral administration of labeled doxazosin to pregnant rats.
Danish: Radioaktivitet blev fundet at krydse placenta efter oral administration af mærket doxazosin til gravide rotter.
English: You should check with your doctor or pharmacist if you are not sure.
Danish: De bør snakke med Deres læge eller apotek, hvis de ikke er sikker.
English: Postural hypotension and in rare cases syncope may occur at the beginning of therapy, especially at very high doses but also when treatment is recommenced after a break.
Danish: Postural hypotension og i sjældne tilfælde synkope kan forekomme ved begyndelsen af behandlingen, især ved meget høje doseringer, men også når behandlingen genoptages efter en pause.
English: Take any remaining tablets and the container with you.
Danish: Tag alle tiloverblevne tabletter og beholderen med dem.
English: Increase in plasma renin activity and tachycardia have rarely been seen during long-term treatment.
Danish: Øgning i plasma renin aktivitet og takykardi er sjældent blevet set under længerevarende behandling.
English: It contains Doxazosin, which belongs to a group of medicines called alpha-blockers.
Danish: Den indeholderdoxazosin, der hører til en gruppe af lægemidler, der kaldes alfa-blokkere.
English: Cellulose, microcrystalline Povidone K 29-32
Danish: Mikrokrystallinsk cellulose Povidon K 29-32
English: Doxazosin has shown to be an effective blocker of 1A subtype of alpha-adrenoceptors which make up more than 70% of the adrenergic subtypes in prostate.
Danish: Doxazosin har vist sig at være en effektiv blokker af 1A undertype af alfa-adrenoreceptorer, der udgør mere end 70% af de adrenerge undertyper i prostata.
English: The empty tablet will be passed out in your stools.
Danish: Den tomme tablet vil blive udskilt i Deres affføring.
English: • if you have taken medicine containing Doxazosin or a similar medicine eg.
Danish: • hvis De har taget et lægemiddel indeholdende Doxazosin eller et lignende lægemiddel, f.eks.
English: This effect is thought to result from selective blockade of the alpha-1adrenoceptors located in the vasculature.
Danish: Denne virkning menes at være et resultat af selektiv blokade af alfa1-adrenoreceptorer lokaliseret i vaskulaturen.
English: Most of the patients with prostatic hyperplasia are controlled with the initial dose.
Danish: De fleste af patienterne med prostatahyperplasi kontrolleres med den indledende dosis.
English: Doxazosin has a beneficial effect on blood lipids with significant increase of HDL/total cholesterol ratio (app. 4-13% of base line values), and significant reduction in total glycerides and total cholesterol.
Danish: Doxazosin har en gavnlig virkning på blodlipider med signifikant øgning af HDL/total cholesterol ratio (ca. 4-13% af base line værdierne) og signifikant reduktion af totale glycerider og total cholesterol.
English: On initiation of therapy or increasing of dose the patient should be monitored to minimise the potential for postural effects, e.g. hypotension and syncope.
Danish: Ved indledningen af behandlingen eller øgning af dosis bør patienten overvåges for at minimere muligheden for posturale virkninger, f.eks. hypotension og synkope.
English: Do not worry if sometimes you notice the tablet shell in your stools.
Danish: De skal ikke være bekymret, hvis De lægger mærke til tabletskallen i deres afføring.
English: • if you are allergic to any of the tablet ingredients
Danish: • hvis De er overfølsom over for nogen af indholdsstofferne i tabletten
English: LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S)/MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
Danish: FORTEGNELSE OVER LÆGEMIDLETS/LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: Habituation has not been observed during long-term treatment with doxazosin.
Danish: Tilvænning er ikke blevet observeret under længerevarende behandling med doxazosin.
English: The plasma elimination is biphasic with the terminal elimination half-life being 22 hours and hence this provides the basic for once daily dosing
Danish: Plasmaeliminationen er bifasisk med den terminale eliminationshalveringstid værende 22 timer, og dette giver derfor basis for doseringen én gang daglig.
English: There are no studies concerning interactions with agents influencing hepatic metabolism.
Danish: Der foreligger ikke nogen undersøgelser vedrørende interaktioner med midler, der øver inflydelse på levermetabolismen.
English: Common: apathia
Danish: Almindelig: Apati
English: Additionally, doxazosin improves insulin sensitivity in patients with impaired sensitivity to insulin, but also concerning this finding the clinical relevance is still uncertain.
Danish: Yderligere forbedrer doxazosin insulinfølsomheden hos patienter med forringet følsomhed over for insulin, men også med hensyn til dette fund er den kliniske relevans stadig usikker.
English: With once daily dosing, clinically significant reductions in blood pressure are present throughout the day and at 24-hours post dose.
Danish: Med én gang daglig dosering er klinisk signifikante reduktioner i blodtrykket tilstede gennem dagen og ved 24 timer efter dosering.
English: Your medicine is in the form of a ‘prolonged-release' tablet.
Danish: Deres medicin er i form af en 'depottablet.
English: In hypertensive patients with one or more additional risk factors for cardiovascular disease, doxazosin should not be used as a single agent for the first-line treatment of hypertension due to a possible increased risk for development of heart failure.
Danish: Hos hypertensive patienter med en eller flere yderligere risikofaktorer for kardiovaskulær lidelse, bør doxazosin ikke anvendes som et enkelt middel som førstevalgs behandling af hypertension grundet en mulig øget risiko for udvikling af hjertesvigt.
English: • if you have diabetes
Danish: • hvis De har sukkersyge
English: Studies in lactating rats given a single oral dose of radioactive doxazosin gave an accumulation in breast milk with a maximum concentration of about 20 times greater than the maternal plasma concentration.
Danish: Undersøgelser af ammende rotter, der fik en enkelt oral dosis radioaktiv doxazosin, gav en akkumulering i modermælken med en maksimal koncentration på omkring 20 gange større end moderens plasmakoncentration.
English: Nonsteroidal antirheumatics or estrogens may reduce the antihypertensive effect of doxazosin.
Danish: Non-steroide antirheumatika eller østrogener kan nedsætte den antihypertensive virkning af doxazosin.
English: Animal studies have shown reduced foetal survival at high doses (see section 5.3).
Danish: Dyreundersøgelser har vist nedsat føtal overlevelse ved høje doser (se pkt.
English: Pharmacotherapeutic group: Alpha-adrenoceptor antagonists, ATC code: C02CA04
Danish: Farmakoterapeutisk klassifikation: Alfa-adrenoreceptorantagonister ATC-kode: C02CA04
English: • if you have kidney problems such as bladder stones, difficulty passing urine or suffer from frequent urine infections.
Danish: • hvis De har nyreproblemer, såsom blæresten, vandladningsbesvær eller lider af hyppige urinvejsinfektioner
English: This medicinal product is authorised in the Member States of the EEA under the following names: [See Annex I - To be completed nationally]
Danish: Dette lægemiddel er godkendt i EEA medlemslandene under følgende navne: [Udfyldes ved afslutningen af proceduren]
English: Must not be chewed, divided or crushed.
Danish: Må ikke tygges, deles eller knuses.
English: Doxazosin is highly bound to plasma proteins (98%).
Danish: Doxazosin er stærkt bundet til plasmaproteiner (98%).
English: Since doxazosin is strongly bound to plasma proteins dialysis is not indicated.
Danish: Da doxazosin er stærkt bundet til plasmaproteiner er dialyse ikke indiceret.
English: In vitro data in human plasma indicate that doxazosin has no effect on protein binding of digoxin, warfarin, phenytoin or indomethacin.
Danish: In vitro data for humant plasma indikerer, at doxazosin ikke har nogen virkning på proteinbindingen af digoxin, warfarin, fenytoin eller indometacin.
English: Special care should be taken with hypotensive patients or patients with known orthostatic dysregulation taking doxazosin to treat benign prostatic hyperplasia (BPH).
Danish: Man bør passe særlig på hypotensive patienter eller patienter med kendt ortostatisk dysregulation, der tager doxazosin for at behandle benign prostatahyperplasi (BPH).
English: Distribution: App. 98% of doxazosin is protein-bound in plasma.
Danish: Distribution: Cirka 98% af doxazosin er proteinbundet i plasma.
English: In patients treated for benign prostatic hyperplasia and without hypertension mean blood pressure changes are small, but hypotension, dizziness, fatigue occur in 10 - 20% of the patients and oedema and dyspnoea occur in less than 5% of patients.
Danish: Hos patienter behandlet for benign prostatahyperplasi og uden hypertension er ændringer i middelblodtrykket små, men hypotension, svimmelhed, træthed forekommer hos 10 - 20% af patienterne, og ødem og dyspnøe forekommer hos mindre end 5% af patienterne.