FrancophonIA/ELRC3.0 huggingface dataset:
English: • patients without EGFR activating mutations in whom previous chemotherapy has not worked and other treatments are unsuitable.
Danish: • patienter uden EGFR-aktiverende mutationer, hos hvem tidligere kemoterapi ikke har virket, og andre behandlinger ikke er egnede.
English: • A third study compared Tarceva with placebo in 643 patients with advanced NSCLC whose cancer cells did not have EGFR activating mutations and whose disease was stable after 4 cycles of treatment with platinum-containing chemotherapy.
Danish: • I et tredje studie blev Tarceva sammenlignet med placebo hos 643 patienter med fremskreden ikkesmåcellet lungekræft, hvis kræftceller ikke havde EGFR-aktiverende mutationer, og hvis sygdom var stabil efter 4 serier platinholdig kemoterapi.
English: • The second study compared Tarceva with placebo (a dummy treatment) in 889 patients with advanced or metastatic NSCLC whose disease had not got worse after 4 cycles of treatment with platinum-containing chemotherapy.
Danish: • I det andet studie blev Tarceva sammenlignet med placebo (en uvirksom behandling) hos 889 patienter med fremskreden eller metastaseret ikkesmåcellet lungekræft, hvis sygdom ikke var forværret efter 4 serier platinholdig kemoterapi.
English: Patients with metastatic cancer taking Tarceva as initial therapy lived without their disease getting worse for an average of 5.9 months, compared with 5.1 months in those taking placebo.
Danish: De patienter med metastaserende kræft, der tog Tarceva som indledende behandling, levede gennemsnitligt i 5,9 måneder uden sygdomsforværring sammenholdt med 5,1 måneder for dem, der tog placebo.
English: • The first study compared Tarceva with chemotherapy in 173 patients with advanced NSCLC with activating EGFR mutations who had not received previous chemotherapy.
Danish: • I det første studie blev Tarceva sammenlignet med kemoterapi hos 173 patienter, som havde fremskreden ikkesmåcellet lungekræft med aktiverende EGFR-mutationer, og som ikke tidligere havde fået kemoterapi.
English: Patients taking Tarceva lived for an average of 10.4 months without their disease getting worse compared with 5.1 months for those receiving chemotherapy medicines.
Danish: De patienter, som tog Tarceva, levede gennemsnitligt i 10,4 måneder uden sygdomsforværring sammenlignet med 5,1 måneder hos dem, der fik kemoterapi.
English: • patients with EGFR activating mutations in whom previous chemotherapy has not worked;
Danish: • patienter med EGFR-aktiverende mutationer, hos hvem tidligere kemoterapi ikke har virket
English: How does Tarceva work?
Danish: Hvordan virker Tarceva?
English: They are used together when treatment with just one is insufficient.
Danish: De bruges sammen, når behandling med den ene ikke er tilstrækkeligt.
English: The combination is effective irrespective of age, gender and race.
Danish: Kombinationen er effektiv uanset alder, køn og race.
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne:>
English: Very common ≥ 1/10 Common
Danish: Meget almindelig ≥ 1/10 Almindelig
English: The usual dose is one tablet each day.
Danish: Den sædvanlige dosis er én tablet daglig.
English: It also makes it easier for your heart to pump blood around your body.
Danish: Det gør det også lettere for hjertet at pumpe blodet rundt i kroppen.
English: ≥ 1/100 and < 1/10
Danish: ≥ 1/100 til < 1/10
English: Frequency categories are as follows:
Danish: Der er følgende hyppighedskategorier:
English: This indicates that there is an influence on rate but not on the extent of absorption of both medicines.
Danish: Dette indikerer, at der er en påvirkning af hastigheden, men ikke på omfanget af absorptionen af de to lægemidler.
English: - if you are planning to have an operation (including dental surgery).
Danish: - hvis det er planlagt, at du skal opereres (herunder tandkirurgi).
English: The category `uncommon' incorporates `rare' (≥1/10'000 and <1/1'000) and `very rare' (<1/10'000), which may be used in some SPCs for other products.
Danish: Kategorien ”ikke almindelig” inkluderer ”sjælden” (≥ 1/10.000 og < 1/1.000) og ”meget sjælden” (< 1/10.000), som kan være anvendt i nogle produktresuméer for andre produkter.
English: In some cases, reducing the dose may help.
Danish: I nogle tilfælde kan dosisnedsættelse hjælpe.
English: However, always take it around the same time.
Danish: Du skal dog altid tage det på omtrent samme tid på dagen.
English: It works by increasing the amount of water (urine) you produce.
Danish: Det virker ved at øge mængden af urin du producerer.
English: If you feel dizzy, do not drive or use any tools or machines.
Danish: Hvis du føler dig svimmel, må du ikke køre motorkøretøj eller arbejde med værktøj eller maskiner.
English: Italy, Portugal: Inibace Plus
Danish: Italien, Portugal: Inhibace Plus
English: No tests of carcinogenicity were conducted with the combination.
Danish: Der blev ikke udført karcinogenicitetstest for kombinationen.
English: Taking this medicine - Swallow each tablet with a drink of water.
Danish: Sådan skal du tage denne medicin - Synk hver tablet med et glas vand.
English: Do not take Vascace Plus if any of the above apply to you.
Danish: Tag ikke Vascace Plus, hvis et eller flere af ovenstående punkter gælder for dig.
English: The tablets must not be chewed or crushed and should always be swallowed with a drink of water.
Danish: Tabletten må ikke tygges eller knuses og skal altid synkes med et glas vand.
English: - Medicines called ‘non-steroidal anti-inflammatory drugs' (NSAIDs).
Danish: - Medicin kaldet ”non-steroide antiinflammatoriske lægemidler” (NSAID'er).
English: A variant form is angioedema of the intestine, which tends to occur within the first 24-48 hours of treatment.
Danish: En variant er angioødem i tarmen, som sædvanligvis forekommer inden for de første 24-48 timer efter behandlingsstart.
English: The two active substances work together to lower your blood pressure.
Danish: De to aktive stoffer arbejder sammen om at sænke dit blodtryk.
English: - Iodine containing contrast media (given to patients before certain types of X-ray examination).
Danish: - Kontraststof som indeholder iod (gives til patienter før visse typer af røntgenundersøgelser).
English: Austria: Inhibace Plus “Roche” Belgium, Luxembourg: Co-Inhibace Cyprus, Greece: Vascace Plus Czech Republic, Hungary, Poland, Spain: Inhibace Plus Germany: Dynorm Plus
Danish: Østrig: Inhibace Plus ”Roche” Belgien, Luxembourg: Co-Inhibace Cypern, Grækenland: Vascace Plus Tjekkiet, Ungarn, Polen, Spanien: Inhibace Plus Tyskland: Dynorm Plus
English: There is limited experience with hydrochlorothiazide during pregnancy.
Danish: Der er begrænset erfaring med hydrochlorthiazid under graviditet.
English: Vascace Plus is not suitable for people with certain types of heart problem.
Danish: Vascace Plus er ikke egnet til personer med visse typer hjerteproblemer.
English: Reductions in maternal blood volume could also adversely affect placental perfusion.
Danish: Reduktion i maternel blodvolumen kan også påvirke den placentale perfusion negativt.
English: Do not use Vascace Plus after the expiry date which is stated on the pack after EXP.
Danish: Brug ikke Vascace Plus efter den udløbsdato (EXP), der står på pakningen.
English: Pharmacokinetics in Special Populations
Danish: Farmakokinetik i specielle populationer
English: Consideration should be given to using a different type of dialysis membrane or different class of antihypertensive agent in such patients.
Danish: Det skal overvejes at bruge en anden type dialysemembran eller en anden klasse af antihypertensivum til disse patienter.
English: This phenomenon appeared to be more likely to occur during the first weeks of combined treatment and in patients with renal impairment.
Danish: Risikoen for dette fænomen syntes at være større i de første uger af kombinationsbehandlingen og hos patienter med nedsat nyrefunktion.
English: Cough is more common in women and nonsmokers.
Danish: Hoste forekommer oftere hos kvinder og ikke-rygere.
English: This is because some anaesthetics can lower your blood pressure, and it may become too low.
Danish: Årsagen er, at nogle bedøvelsesmidler kan nedsætte dit blodtryk, så det kan blive for lavt.
English: Vascace Plus is used to treat high blood pressure.
Danish: Vascace Plus bruges til at behandle for højt blodtryk.
English: At recommended doses, the effect of cilazapril in hypertensive patients is maintained for up to 24 hours.
Danish: Ved de anbefalede doser opretholdes effekten af cilazapril hos hypertensive patienter i op til 24 timer.
English: Hydrochlorothiazide should not be used for the treatment of essential hypertension in pregnant women except in rare situations where no other therapy can be used.
Danish: Hydrochlorthiazid må ikke anvendes til behandling af essentiel hypertension hos gravide kvinder undtagen i sjældne tilfælde, hvor ingen anden behandling kan anvendes.
English: The main findings were increased pre-implantation loss and fewer viable foetuses.
Danish: De primære fund var stigning i præimplantationstab og færre levedygtige fostre.
English: - if you have diabetes.
Danish: - hvis du har sukkersyge (diabetes).
English: As food intake has no clinically significant influence on absorption, Vascace Plus can be administered before or after a meal.
Danish: Da indtagelse af føde ikke har nogen klinisk signifikant indvirkning på absorptionen, kan Vascace Plus indtages før eller efter et måltid.
English: - Cyclosporine (used to stop the rejection of organs after transplantation).
Danish: - Ciclosporin (anvendes til at hindre afstødning af transplanterede organer).
English: Therefore, Vascace Plus is not recommended for administration to this population.
Danish: Derfor anbefales Vascace Plus ikke til denne population.
English: Limited data suggest that the systemic clearance of hydrochlorothiazide is reduced in both healthy and hypertensive elderly patients compared to young healthy volunteers.
Danish: Begrænsede data antyder, at den systemiske clearance af hydrochlorthiazid er reduceret hos både raske og hypertensive ældre patienter sammenlignet med unge raske frivillige.
English: If you forget to take Vascace Plus - If you forget to take a dose, skip the missed dose.
Danish: Hvis du har glemt at tage Vascace Plus - Hvis du glemmer at tage en dosis, skal du springe den glemte dosis over.
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however, a small increase in risk cannot be excluded.
Danish: Epidemiologisk evidens vedrørende risikoen for teratogenicitet efter eksponering for ACE-hæmmere under første trimester af graviditeten er ikke entydig, dog kan en lille øgning af risikoen ikke udelukkes.
English: If concomitant use is indicated because of demonstrated hypokalaemia they should be used with caution and with frequent monitoring of serum potassium.
Danish: Hvis samtidig anvendelse er indiceret på grund af påvist hypokaliæmi, skal de anvendes med forsigtighed og med hyppig monitorering af serumkalium.
English: Patients should start treatment with Vascace Plus only after they have been stabilized on each component given at the same dose as in the combined product.
Danish: Patienter bør kun starte behandling med Vascace Plus, efter de er blevet stabiliseret med hver komponent i samme dosis som i kombinationspræparatet.
English: It delays hydrochlorothiazide Tmax by 1.4 hours and reduces Cmax by 14% with no effect on overall bioavailability of both molecules as assessed by AUC0-24-value.
Danish: Det forsinker hydrochlorthiazids Tmax med 1,4 timer og reducerer Cmax med 14 % uden effekt på den overordnede biotilgængelighed af de to molekyler, vurderet ud fra AUC0-24-værdierne.
English: Estimates of frequency are based on the proportion of patients reporting each adverse reaction during Vascace Plus clinical trials that included a total combined population of 1'097 patients.
Danish: Hyppighedsestimater er baseret på andelen af patienter, som rapporterede de enkelte bivirkninger i kliniske forsøg med Vascace Plus, som omfattede en samlet population på 1.097 patienter.
English: Hydrochlorothiazide is rapidly absorbed following oral administration of Vascace Plus.
Danish: Hydrochlorthiazid absorberes hurtigt efter oral administration af Vascace Plus.
English: The mean lethal doses in rats, mice, and cynomolgus monkeys were higher than 2000 mg/kg body weight.
Danish: De gennemsnitlige dødelige doser hos rotter, mus og cynomolgusaber var højere end 2.000 mg/kg legemsvægt.
English: Vascace Plus is indicated for the treatment of hypertension in adult patients whose blood pressure is not adequately controlled with cilazapril alone.
Danish: Vascace Plus er indiceret til behandling af hypertension hos voksne patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med cilazapril alene.
English: Use in children and adolescents Vascace Plus is not recommended for use in children and adolescents below 18 years of age.
Danish: Brug hos børn og unge Vascace Plus anbefales ikke til børn og unge under 18 år.
English: The combination at various doses produces greater blood pressure reduction than either of the two individual components.
Danish: Ved forskellige doser forårsager kombinationen en større blodtrykssænkning end hver af de to aktive stoffer.
English: This is more likely to happen when you first start treatment.
Danish: Sandsynligheden for dette er størst i starten af behandlingen.
English: Non-depolarizing muscle relaxants should not be administered simultaneously, due to possible intensification and prolongation of the muscular relaxing effect.
Danish: Ikke polariserende muskelrelaksantia bør ikke administreres samtidig, pga. eventuel forøgelse og forlængelse af den muskelafslappende effekt.
English: A slightly higher incidence of pelvic dilation was observed in rats at 5 mg/kg/day.
Danish: En anelse højere incidens af bækkenudvidelse blev observeret hos rotter ved 5 mg/kg/dag.
English: Studies on the effect on peri- and postnatal performance and on fertility were not conducted with the combination.
Danish: Der blev ikke udført studier vedrørende effekten på peri- og postnatal udvikling og på fertilitet for kombinationen.
English: Vascace Plus is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Danish: Vascace Plus anbefales ikke til mødre, som ammer, og lægen vil muligvis vælge en anden behandling til dig, hvis du ønsker at amme, især hvis dit barn er nyfødt eller for tidligt født.
English: Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.
Danish: Patienterne skal være tilstrækkeligt hydrerede, og det skal overvejes at monitorere nyrefunktionen efter påbegyndelse af den samtidige behandling og regelmæssigt derefter.
English: The recommended treatment of Vascace Plus overdosage is intravenous infusion of sodium chloride 9 mg/ml (0.9%) solution.
Danish: Den anbefalede behandling af overdosering med Vascace Plus består af intravenøs infusion af natriumchloridopløsning 9 mg/ml (0,9 %).
English: An additive effect may be observed when Vascace Plus is administered in combination with other antihypertensive agents.
Danish: En additiv effekt kan observeres, når Vascace Plus administreres i kombination med andre antihypertensiva.
English: They occurred only at 50 mg/kg corresponding to high multiples of therapeutic human doses.
Danish: De forekom kun ved 50 mg/kg svarende til doser, som er mange gange højere end de terapeutiske doser hos mennesker.
English: Therefore, the combination of cilazapril with the above-mentioned drugs is not recommended (see section 4.4).
Danish: Kombination af cilazapril med de ovennævnte lægemidler anbefales derfor ikke (se pkt.
English: Like all medicines, Vascace Plus can cause side effects, although not everybody gets them.
Danish: Vascace Plus kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Reasons may include (i) differences between the target populations treated with Vascace Plus and Vascace, (ii) differences in cilazapril dose, and (iii) specific effects of combination therapy.
Danish: Forskellen kan skyldes (1) forskelle i målgrupperne behandlet med Vascace Plus og Vascace, (2) forskelle i cilazaprildosis og (3) specifikke effekter ved kombinationsbehandling.
English: Vascace Plus is contraindicated in patients with creatinine clearance <30 ml/min/1.73 m2.
Danish: Vascace Plus er kontraindiceret hos patienter med kreatininclearance < 30 ml/min/1,73 m2.
English: - Do not crush or chew the tablets
Danish: - Du må ikke knuse eller tygge tabletterne.
English: Interactions mainly related to cilazapril
Danish: Interaktioner hovedsageligt relateret til cilazapril
English: In elderly patients whose renal function is normal for age, plasma concentrations of cilazaprilat may be up to 40% higher, and clearance 20% lower, than in younger patients.
Danish: Hos ældre patienter med normal nyrefunktion for deres alder kan plasmakoncentrationen af cilazaprilat være op til 40 % højere og clearance 20 % lavere end hos yngre patienter.
English: Cilazapril did no show any mutagenic or genotoxic effect in various mutagenicity tests, performed in vitro and in vivo.
Danish: Cilazapril viste ingen mutagen eller genotoksisk effekt i adskillige mutagenicitetstest, udført in vitro og in vivo.
English: - Vascace Plus may be taken before or after a meal.
Danish: - Du kan tage Vascace Plus inden eller efter et måltid.
English: Taking Vascace Plus with food and drink Vascace Plus my be taken with or without food.
Danish: Brug af Vascace Plus sammen med mad og drikke Vascace Plus kan tages med eller uden mad.
English: Maximum plasma concentrations of cilazaprilat are consistently achieved within 2 hours.
Danish: Den maksimale plasmakoncentration af cilazaprilat nås gennemgående inden for 2 timer.
English: If you have a severe reaction called angioedema, stop taking Vascace Plus and see a doctor straight away.
Danish: Hvis du får en alvorlig reaktion kaldet angioødem, skal du stoppe med at tage Vascace Plus og straks kontakte en læge.
English: This may make you feel weak, dizzy or light-headed, and may lead to blurred vision and fainting.
Danish: Dette kan gøre, at du føler dig svag og svimmel eller ør i hovedet og kan medføre sløret syn og besvimelse.
English: Vital signs, serum electrolytes and creatinine concentrations should be monitored continuously.
Danish: Vitale tegn, serumelektrolytter og serum-kreatinin skal monitoreres løbende.
English: EXPIRY DATE [To be completed nationally] EXP
Danish: UDLØBSDATO [Udfyldes nationalt] EXP
English: Routine monitoring of potassium and creatinine is part of normal medical practice for patients with renal impairment.
Danish: Rutinemæssig monitorering af kalium og kreatinin er en del af den sædvanlige kliniske praksis for patienter med nedsat nyrefunktion.
English: The bioavailability of hydrochlorothiazide after oral dose is about 65% based on urinary recovery.
Danish: Biotilgængeligheden af hydrochlorthiazid efter oral dosering er ca. 65 % ud fra urindata.
English: cilazapril/hydrochlorothiazide
Danish: cilazapril/hydrochlorthiazid
English: The acute oral toxicity of cilazapril is low.
Danish: Den akutte orale toksicitet af cilazapril er lav.
English: Pharmacotherapeutic group: Antihypertensive; ACE inhibitor and diuretic, ATC code: C09BA08
Danish: Farmakoterapeutisk klassifikation: Antihypertensiva; ACE-hæmmere og diuretika, ATC-kode: C09BA08
English: Cilazapril must be stopped before the start of desensitization therapy, and should not be replaced by a β-blocker.
Danish: Behandling med cilazapril skal stoppes inden påbegyndelse af desensibiliseringsbehandling og bør ikke erstattes af en betablokker.
English: Thiazides may also cause hyponatraemia and dehydration.
Danish: Thiazider kan også forårsage hyponatriæmi og dehydrering.
English: Hypotension and postural hypotension may occur when starting treatment or increasing dose, especially in at-risk patients (see section 4.4).
Danish: Hypotension og postural hypotension kan forekomme, når behandlingen påbegyndes, eller dosis øges, især hos patienter i risikogruppe (se pkt.
English: As with other ACE inhibitors, signs of foetotoxicity were observed in rats.
Danish: Som for andre ACE-hæmmere blev der observeret tegn på føtotoksicitet hos rotter.
English: No clinically significant interactions were observed when cilazapril and digoxin, nitrates, coumarin anticoagulants, and H2-receptor blockers were concomitantly administered.
Danish: Ingen klinisk signifikante interaktioner blev observeret, når cilazapril og digoxin, nitrater, coumarinantikoagulantia og H2-receptorblokkere blev administreret samtidig.
English: Always take Vascace Plus exactly as prescribed.
Danish: Tag altid Vascace Plus nøjagtigt efter lægens anvisning.
English: Subchronic and chronic toxicity studies with hydro-chlorothiazide in rats and dogs showed no noticeable findings except for changes in the electrolyte balance (hypokalaemia).
Danish: Subkroniske og kroniske toksicitetsstudier med hydrochlorthiazid hos rotter og hunde viste ingen påfaldende fund bortset fra ændringer i elektrolytbalancen (hypokaliæmi).
English: Maximum plasma concentrations are achieved within 2 hours post dosing.
Danish: Den maksimale plasmakoncentration nås inden for 2 timer.
English: - If you have severe kidney problems (creatinine clearance less than 30 ml/min) or anuria (inability to pass urine).
Danish: - hvis du har alvorlige nyreproblemer (kreatininclearance mindre end 30 ml/min) eller anuri (hvor du ikke producerer urin).
English: Vascace Plus should be used with caution in patients with porphyria.
Danish: Vascace Plus bør anvendes med forsigtighed hos patienter med porfyri.
English: ACE inhibitors are less effective as antihypertensives in patients with black skin colour.
Danish: ACE-hæmmere er mindre effektive som antihypertensiva hos patienter med sort hudfarve.
English: Tell your doctor or pharmacist if you are taking food supplements that contain potassium.
Danish: Fortæl din læge eller på apoteket, hvis du tager kosttilskud, som indeholder kalium.
English: Other metabolic disorders
Danish: Andre metaboliske sygdomme
English: Do not take Vascace Plus - if you are allergic (hypersensitive) to cilazapril, hydrochlorothiazide or any of the other ingredients of Vascace Plus (listed in section 6: Further information).
Danish: Tag ikke Vascace Plus - hvis du er allergisk (overfølsom) over for cilazapril, hydrochlorthiazid eller et af de øvrige indholdsstoffer (anført i afsnit 6: Yderligere oplysninger).
English: As with other ACE inhibitors, the kidney was the primary target of systemic toxicity in subchronic and chronic toxicity studies with cilazapril alone.
Danish: Som for andre ACE-hæmmere er nyrerne det primære mål for systemisk toksicitet i subkroniske og kroniske toksicitetsstudier med cilazapril alene.
English: - Calcium supplements and vitamin D. - Cholestyramine/colestipol (used for reducing the amount of fat in your blood).
Danish: - Kalktilskud og vitamin D. - Colestyramin/colestipol (anvendes til at nedsætte fedtindholdet i blodet).
English: Pacemaker therapy is indicated for therapy-resistant bradycardia.
Danish: Behandling med pacemaker er indiceret ved behandlingsresistent bradykardi.
English: - if you have had a serious side effect called angioedema after taking other ACE inhibitor medicines, hereditary angioedema or angioedema of unknown cause.
Danish: - hvis du har haft en alvorlig bivirkning, som kaldes angioødem efter at have taget en anden ACE-hæmmer, eller lider af arvelig angioødem eller angioødem af ukendt årsag.
English: Safety and efficacy in children and adolescents below 18 years of age have not been established.
Danish: Sikkerhed og virkning af Vascace Plus hos børn og unge under 18 år er ikke klarlagt.
English: Cyclosporine
Danish: Ciclosporin