FrancophonIA/ELRC3.0 huggingface dataset:
English: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Take special care with Clopidogrel Sandoz').
Danish: Hvis De er bekymret over Deres blødning, skal De omgående kontakte Deres læge (se afsnit 2 'Vær ekstra forsigtig med at tage Clopidogrel Sandoz').
English: • Pharmacogenetics
Danish: • Farmakogenetik
English: Clopidogrel Sandoz 75 mg film-coated tablets are white to off-white, marbled, round and biconvex.
Danish: Clopidogrel Sandoz 75 mg filmovertrukne tabletter er hvide til råhvide, marmorerede, runde og bikonvekse.
English: Clopidogrel Sandoz contains the active ingredient Clopidogrel which belongs to a group of medicines called antiplatelet medicinal products.
Danish: Clopidogrel Sandoz indeholder det aktive indholdsstof clopidogrel, som tilhører en gruppe medicin, der kaldes blodforyndende medicin.
English: In a crossover clinical study, clopidogrel (300-mg loading dose followed by 75 mg/day) alone and with omeprazole (80 mg at the same time as clopidogrel) were administered for 5 days.
Danish: Syrepumpehæmmere (PPI): I et klinisk crossover-studie blev clopidogrel (300 mg mætningsdosis efterfulgt af 75 mg/dag) administreret alene og sammen med omeprazol (80 mg på samme tidspunkt som clopidogrel) i 5 dage.
English: If you become pregnant while taking Clopidogrel Sandoz, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Danish: Hvis De bliver gravid, mens De tager Clopidogrel Sandoz, skal De omgående kontakte Deres læge, da det frarådes at tage Clopidogrel Sandoz hvis De er gravid.
English: If you forget to take Clopidogrel Sandoz
Danish: Hvis De har glemt at tage Clopidogrel Sandoz
English: You should take Clopidogrel Sandoz for as long as your doctor continues to prescribe it.
Danish: De skal fortsætte med at tage Clopidogrel Sandoz, så længe Deres læge udskriver det til Dem.
English: If you experience prolonged bleeding when taking Clopidogrel Sandoz.
Danish: Hvis De får langvarige blødninger, mens De tager Clopidogrel Sandoz.
English: • You should tell your doctor if a surgery (including dental) is planned.
Danish: • Bør De fortælle Deres læge, at De er i behandling med Clopidogrel Sandoz hvis De skal have foretaget en planlagt operation (også hos tandlægen),.
English: Clopidogrel Sandoz is taken to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Danish: Clopidogrel Sandoz tages for at forebygge dannelse af blodpropper (trombi) i blodårer (arterier), som er blevet stive ved en proces kaldet aterotrombose, hvilket kan føre til f.eks. slagtilfælde, hjerteanfald og død (aterotrombotiske hændelser).
English: Poor metabolism: CYP2C19*2/*2, *2/*3 or *3/*3
Danish: CYP2C19*2/*2, *2/*3 eller *3/*3
English: The active thiol metabolite which has been isolated in vitro, binds rapidly and irreversibly to platelet receptors, thus inhibiting platelet aggregation.
Danish: som er blevet isoleret in vitro, binder hurtigt og irreversibelt til blodpladereceptorerne, hvorved trombocytaggregation hæmmes.
English: Important information about some of the ingredients of Clopidogrel Sandoz: Clopidogrel Sandoz contains hydrogenated castor oil which may cause stomach upset or diarrhoea.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Clopidogrel Sandoz Clopidogrel Sandoz indeholder hydrogeneret ricinusolie, der kan forårsage mavetilfælde eller diarré
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis De vil have yderligere oplysninger om dette lægemiddel, skal De henvende Dem til indehaveren af markedsføringstilladelsen.
English: Always take Clopidogrel Sandoz exactly as your doctor has told you.
Danish: Tag/brug altid Clopidogrel Sandoz nøjagtigt efter lægens anvisninger.
English: Gastrointestinal haemorrhage, diarrhoea, abdominal pain, dyspepsia
Danish: Mave-tarmkanalen Gastrointestinal blødning, diarré, abdominalsmerter, dyspepsi
English: Excipients Clopidogrel Sandoz contains hydrogenated castor oil which may cause stomach upset and diarrhoea.
Danish: Clopidogrel Sandoz indeholder hydrogeneret ricinusolie, hvilket kan forårsage maveproblemer og diarré.
English: The usual dose is one 75 mg tablet of Clopidogrel Sandoz per day to be taken orally with or without food, and at the same time each day.
Danish: Den normale dosis er 1 tablet Clopidogrel Sandoz à 75 mg daglig, som indtages gennem munden alene eller i forbindelse med et måltid.
English: If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Sandoz: if you have a risk of bleeding such as a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer) a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body) a recent serious injury a recent surgery (including dental) a planned surgery (including dental) in the next seven days if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days
Danish: en medicinsk lidelse, der medfører risiko for indre blødninger (såsom et mavesår) en blødningslidelse, der giver Dem tendens til indre blødning (blødning inde i et af kroppens væv, organer eller led) en nylig alvorlig kvæstelse et nyligt kirurgisk indgreb (gælder også tandoperationer) et planlagt kirurgisk indgreb (gælder også tandoperationer) inden for de næste 7 dage
English: signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 ‘Take special care with Clopidogrel Sandoz').
Danish: Dette kan ske på grund af et sjældent fald i visse blodlegemer - tegn på leverproblemer såsom gulning af huden og/eller øjnene (gulsot), uanset om det sker i forbindelse med blødninger, som viser sig under huden som små røde prikker, og/eller forvirring (se afsnit 2 'Vær ekstra forsigtig med at tage Clopidogrel Sandoz) - hævelser i munden eller hudproblemer såsom udslæt og kløe, blister på huden.
English: In CLARITY and one of the cohort studies (n = 765; Trenk),
Danish: I CLARITY og et af kohortestudierne (n=765; Trenk) var der ingen signifikant forskel i kardiovaskulære hændelser genotyperne imellem.
English: Do not take Clopidogrel Sandoz: • If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of
Danish: • Hvis De er overfølsom (allergisk) over for clopidogrel eller et af de øvrige indholdsstoffer i
English: Clopidogrel Sandoz 75 mg film-coated tablets Clopidogrel
Danish: Clopidogrel Sandoz 75 mg filmovertrukne tabletter Clopidogrel
English: While you are taking Clopidogrel Sandoz:
Danish: Mens De er i behandling med Clopidogrel Sandoz:
English: You have a condition of hardening of arteries (also known as atherosclerosis), and You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease (disturbed blood flow in arms or legs caused by vascular
Danish: De har fået recept på Clopidogrel Sandoz til forebyggelse af blodpropper og nedsættelse af risikoen for disse alvorlige hændelser, fordi: - De lider af åreforkalkning (også kaldet aterosklerose) - og - De tidligere har haft et hjerteanfald, slagtilfælde eller en tilstand kaldet perifer arteriel sygdom (kredsløbsforstyrrelser i arme eller ben, forårsaget af vaskulær okklusion)
English: Extensive metabolism: CYP2C19*1/*1 Intermediate metabolism: CYP2C19*1/*2 or *1/*3
Danish: CYP2C19*1/*2 eller *1/*3
English: Clopidogrel Sandoz 75 mg
Danish: INFORMATION I BRAILLE-SKRIFT Clopidogrel Sandoz 75 mg
English: Rash, pruritus, skin bleeding (purpura)
Danish: Pruritus, kløe, purpura
English: You have been prescribed Clopidogrel Sandoz to help prevent blood clots and reduce the risk of these severe events because:
Danish: De tager Clopidogrel Sandoz: Hvis de har risiko for blødninger f.eks. på grund af:
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Sandoz 75 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Clopidogrel Sandoz 75 mg filmovertrukne tabletter
English: While taking Clopidogrel Sandoz, consult your doctor about the breast-feeding of a baby.
Danish: Under behandlingen med Clopidogrel Sandoz skal De tale med Deres læge om amning.
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Sandoz 75 mg film-coated tablets Clopidogrel
Danish: LÆGEMIDLETS NAVN Clopidogrel Sandoz 75 mg filmovertrukne tabletter Clopidogrel
English: Take special care with Clopidogrel Sandoz:
Danish: Vær ekstra forsigtig med at bruge Clopidogrel Sandoz:
English: - cimetidine, medicine to treat upset stomach - fluoxetine, fluvoxamine, or moclobemide, medicines to treat depression - carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy - ticlopidine, other antiplatelet agent.
Danish: Det er særlig vigtigt, at De fortæller det til Deres læge, hvis De tager blodfortyndende medicin, der tages gennem munden for at nedsætte dannelse af blodpropper, en type smertestillende medicin (nonsteroide antiinflammatoriske lægemidler, NSAID'er), som normalt gives til behandling af smertefulde og/eller betændelseslignende tilstande i muskler eller led, heparin eller anden medicin til at nedsætte dannelse af blodpropper en syrepumpehæmmer (f.eks. omeprazol) mod for meget mavesyre, fluconazol, voriconazol, ciprofloxacin eller chloramphenicol, der anvendes til behandling af bakterie- og svampeinfektioner, cimetidin mod for meget mavesyre, fluoxetin, fluvoxamin eller moclobemid, medicin der anvendes mod depression, carbamazepin eller oxcarbazepin, medicin der anvendes mod bestemte former for epilepsi ticlopidin, der er anden medicin mod blodpropper.
English: Rare
Danish: Øjne
English: Hepato-biliary disorders
Danish: Den aktive tiolmetabolit,
English: Gastrointestinal disorders
Danish: Erfaring fra kliniske undersøgelser
English: The protocols, abstracts and final study reports shall be submitted in the format set out in Annex III of Commission Implementing Regulation (EC) No 520/2012.
Danish: Protokoller, sammenfatninger og endelige undersøgelsesrapporter forelægges i det format, der foreskrives i Kommissionens gennemførelsesforordning (EU) nr. 520/2012.
English: The MAH shall conduct a non-interventional post-authorisation safety study (PASS) to evaluate the safety of Targocid in adults with Gram-positive infections who are exposed to the higher loading dose of 12mg/kg twice a day (24 mg/kg/day).
Danish: Sikkerhedsundersøgelse efter markedsføring (PASS) Indehaveren af markedsføringstilladelsen udfører en ikke-interventionel sikkerhedsundersøgelse efter markedsføring (PASS) til vurdering af sikkerheden af Targocid hos voksne, der har grampositive infektioner og eksponeres for den højere initialdosering på 12 mg/kg to gange dagligt (24 mg/kg/dag).
English: The protocol of this non-interventional PASS shall be submitted within 2 months of the Commission Decision.
Danish: Protokollen til denne ikke-interventionelle PASS forelægges senest 2 måneder efter Kommissionens afgørelse.
English: The study protocol shall be entered in the EU electronic register of post-authorisation studies (EU PAS Register) before the start of data collection.
Danish: Inden dataindsamlingen begynder, skal undersøgelsens protokol indføres i EU's elektroniske register over undersøgelser efter markedsføring (EU's PAS-register).
English: Risk management plan The MAH shall submit a RMP within 6 months of the Commission Decision.
Danish: Indehaveren af markedsføringstilladelsen forelægger en risikostyringsplan senest seks måneder efter Kommissionens afgørelse.
English: This is a long-term treatment, possibly lasting for months or years.
Danish: Dette er en længerevarende behandling, der muligvis kan vare i måneder eller år.
English: This will help you to remember to take your medicine.
Danish: Dette vil hjælpe dig med at huske at tage din medicin.
English: There are no adequate and well-controlled studies in pregnant women.
Danish: Der er ikke udført fyldestgørende og velkontrollerede studier hos gravide kvinder.
English: You may take it with or without food.
Danish: Du kan tage det med eller uden mad.
English: Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Danish: Lægen vil undersøge din tilstand regelmæssigt for at kontrollere, at behandlingen har den ønskede virkning.
English: This includes patients:
Danish: Dette omfatter patienter:
English: • A treatment cycle lasts 28 days.
Danish: • En behandlingsserie varer 28 dage.
English: Effect of age, weight, gender and race
Danish: Effekt af alder, vægt, køn og race
English: Follow all of your doctor's instructions carefully.
Danish: Følg alle lægens anvisninger omhyggeligt.
English: Switching the endocrine combination partners was also not permitted.
Danish: Det var heller ikke tilladt at skifte de endokrine kombinationspartnere.
English: This includes in particular:
Danish: Dette omfatter især:
English: It is very important to follow your doctor's instructions.
Danish: Det er meget vigtigt at følge lægens anvisninger.
English: Increases in transaminases were observed.
Danish: Der blev observeret stigninger i transaminaser.
English: 34.1% of patients were de novo.
Danish: 34,1 % af patienterne var de novo.
English: Overall survival, NSAI subgroup
Danish: Samlet overlevelse, NSAI subgruppe
English: Number of patients still at risk
Danish: Antal patienter fortsat i risiko
English: No Kisqali this week.
Danish: Ingen Kisqali i denne uge.
English: All patients had an ECOG performance status of 0 or 1.
Danish: Alle patienter havde en ECOG performancestatus på 0 eller 1.
English: ) with clinically meaningful treatment effect.
Danish: ), med klinisk relevant behandlingseffekt.
English: Hazard ratio is based on unstratified Cox model.
Danish: Hazard ratio er baseret på en ustratificeret Cox model.
English: Mark off circle for every tablet you take.
Danish: Afkryds en cirkel for hver tablet, du tager.
English: Take your dose once a day for 3 weeks followed by a 1-week break.
Danish: Tag din dosis én gang daglig i 3 uger, efterfulgt af 1 uges pause.
English: They may differ from the general information in this leaflet.
Danish: De kan være forskellige fra de generelle oplysninger i denne indlægsseddel.
English: Blocking these proteins can slow down the growth of cancer cells and delay the progression of your cancer.
Danish: Blokering af disse proteiner kan nedsætte væksten af kræftceller og udskyde videreudvikling af din kræft.
English: Anticipated interactions
Danish: Forventede interaktioner
English: Patients should be instructed to avoid grapefruit or grapefruit juice.
Danish: Patienter skal informeres om at undgå grapefrugt eller grapefrugtjuice.
English: • If you have any problems with your liver or have previously had any type of liver disease.
Danish: • Hvis du har leverproblemer eller tidligere har haft en hvilken som helst type leversygdom.
English: Do not exceed the recommended dose prescribed by your doctor.
Danish: Du må ikke overskride den anbefalede dosis, som lægen har ordineret.
English: There were no reported cases of torsade de pointes.
Danish: Der blev ikke rapporteret nogen tilfælde af torsade de pointes.
English: If dose reduction is required, the recommended dose reduction guidelines are listed in Table 1.
Danish: Hvis det er påkrævet at reducere dosis, kan de anbefalede retningslinjer for dosisreduktion findes i tabel 1.
English: In vitro interaction data
Danish: In vitro-interaktionsdata
English: In the second OS analysis the study met its key secondary endpoint demonstrating a statistically significant improvement in OS.
Danish: I OS analysen opnåede studiet sit vigtigste sekundære endepunkt, som demonstrerede en statistisk signifikant forbedring i OS.
English: Therefore, Kisqali is unlikely to affect substrates of these enzymes.
Danish: Det er derfor ikke sandsynligt, at Kisqali påvirker substrater for disse enzymer.
English: Kisqali should not be used during pregnancy since it may harm your unborn baby.
Danish: Kisqali bør ikke anvendes under graviditet, da det kan skade dit ufødte barn.
English: There was no evidence of embryo-foetal mortality.
Danish: Der var ingen tegn på embryoføtal dødelighed.
English: Overall survival, overall study population
Danish: Samlet overlevelse, samlet studie-population
English: Other side effects include the following listed below.
Danish: Andre bivirkninger omfatter dem, der er anført nedenfor.
English: There is only limited experience with reported cases of overdosage with Kisqali.
Danish: Der er kun begrænset erfaring med rapporterede tilfælde af overdosering med Kisqali.
English: Event-free probability (%)
Danish: Sandsynlighed for hændelsesfri (%)
English: Kisqali with food and drink
Danish: Kisqali sammen med mad og drikke
English: Kisqali should be taken orally once daily with or without food.
Danish: Kisqali skal tages oralt én gang daglig sammen med eller uden mad.
English: 200 mg*/day * If further dose reduction below 200 mg/day is required, the treatment should be permanently discontinued.
Danish: 200 mg*/dag *Hvis der kræves yderligere dosisreduktion til under 200 mg/dag, skal behandlingen seponeres permanent.
English: Instead, wait until it is time for your next dose and then take your usual dose.
Danish: Vent i stedet, til det er tid til din næste dosis, og tag så din sædvanlige dosis.
English: However, there are no clinical data with these dose adjustments.
Danish: Der foreligger dog ingen kliniske data for disse dosisjusteringer.
English: Patients should be instructed to report any fever promptly.
Danish: Patienterne skal informeres om omgående at indberette enhver form for feber.
English: Patients should be encouraged to take their dose at approximately the same time each day, preferably in the morning.
Danish: Patienterne bør opfordres til at tage deres dosis på omtrent samme tidspunkt hver dag og helst om morgenen.
English: • Reduced level of phosphate in the blood
Danish: • Lavt niveau af fosfat i blodet
English: The treatment should be continued as long as the patient is deriving clinical benefit from therapy or until unacceptable toxicity occurs.
Danish: Behandlingen bør fortsættes, så længe patienten har klinisk gavn af behandlingen, eller indtil der opstår uacceptabel toksicitet.
English: • Reduced level of calcium in the blood, which may sometimes lead to cramps
Danish: • Lavt niveau af calcium i blodet, hvilket nogle gange kan give krampe
English: Substances that are substrates of transporters
Danish: Stoffer, der er transportør-substrater
English: Besides the atrophic changes seen in the testes, which showed a trend towards reversibility, all other changes were fully reversible after a 4-week treatment-free period.
Danish: Bortset fra de atrofiske forandringer, der blev set i testiklerne, som viste en tendens til reversibilitet, var alle andre forandringer fuldt reversible efter en behandlingsfri periode på 4 uger.
English: • with long QT syndrome;
Danish: • med langt QT-syndrom
English: If you take too many tablets, or if someone else takes your medicine, contact a doctor or hospital for advice immediately.
Danish: Hvis du tager for mange tabletter, eller hvis en anden tager din medicin, skal du omgående kontakte en læge eller et hospital for at blive rådgivet.
English: ), with an estimated 41% reduction in relative risk of progression or death in favour of the Kisqali plus fulvestrant arm.
Danish: ), med en estimeret reduktion i relativ risiko for progression eller dødsfald på 41 % til fordel for Kisqali plus fulvestrant-armen.
English: The time to reach Cmax (Tmax) following ribociclib oral administration was between 1 and 4 hours.
Danish: Tiden til at nå Cmax (Tmax) efter oral administration af ribociclib var mellem 1 og 4 timer.
English: The apparent volume of distribution at steady state (Vss/F) was 1090 L based on population pharmacokinetic analysis.
Danish: Det tilsyneladende fordelingsvolumen ved steady state (Vss/F) var 1.090 l baseret på populationsfarmakokinetisk analyse.
English: Recommendations for patients who have elevated AST/ALT grade ≥ 3 at baseline have not been established.
Danish: Anbefalinger for patienter med forhøjede ASAT-/ALAT-niveauer af grad ≥3 ved baseline er ikke fastlagt.
English: The next prescribed dose should be taken at the usual time.
Danish: Den efterfølgende ordinerede dosis skal tages på det sædvanlige tidspunkt.
English: • Strange taste in the mouth (dysgeusia)
Danish: • Underlig smag i munden (dysgeusi)
English: If grade ≥2 abnormalities are noted, more frequent monitoring is recommended.
Danish: Hvis der bemærkes anomalier af grad ≥2, anbefales det at monitorere hyppigere.
English: Children and adolescents Kisqali is not to be used in children and adolescents under 18 years of age.
Danish: Børn og unge Kisqali må ikke anvendes til børn og unge under 18 år.
English: - PFS based on investigator radiological assessment
Danish: - PFS baseret på investigators radiologiske vurdering.
English: The use of Kisqali should be avoided in patients who already have or who are at significant risk of developing QTc prolongation.
Danish: Kisqali bør undgås hos patienter, der allerede har udviklet eller har signifikant risiko for at udvikle QTc-forlængelse.
English: First and second line patients were enrolled in this study (of whom 19.1% had de novo metastatic disease).
Danish: Førstelinje- og andenlinje-patienter blev inkluderet i dette studie (hvoraf 19,1 % havde de novo metastatisk sygdom).
English: Treatment with Kisqali should be initiated by a physician experienced in the use of anticancer therapies.
Danish: Behandling med Kisqali bør initieres af en læge med erfaring i anvendelse af anticancerbehandlinger.
English: Kisqali works by blocking proteins called cyclin-dependent kinases 4 and 6, which are important for the growth and division of cells.
Danish: Kisqali virker ved at blokere proteiner, der kaldes cyclin-afhængige kinaser 4 og 6, som er vigtige for vækst og deling af celler.
English: In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available data).
Danish: Derudover er den tilsvarende hyppighedskategori for hver bivirkning baseret på følgende konvention (CIOMS III): meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra tilgængelige data).
English: levofloxacin and azithromycin.
Danish: levofloxacin og azithromycin.
English: nelfinavir, telaprevir and efavirenz.
Danish: nelfinavir, telaprevir og efavirenz.
English: Patients with measurable disease N=379
Danish: Patienter med målbar sygdom N=379
English: Table 1 Recommended dose modification guidelines
Danish: Tabel 1 Anbefalede retningslinjer for dosisjustering
English: Critical visceral disease
Danish: Kritisk visceral sygdom
English: Numerous other metabolites were detected in both faeces and urine in minor amounts (≤2.78% of the administered dose).
Danish: En række andre metabolitter blev påvist i både fæces og urin i mindre mængder (≤2,78 % af den administrerede dosis).
English: You should not eat grapefruits or drink grapefruit juice during your treatment with Kisqali.
Danish: Du må ikke spise grapefrugter eller drikke grapefrugtjuice under din behandling med Kisqali.
English: Take the next dose at your usual time.
Danish: Tag den næste dosis på dit sædvanlige tidspunkt.
English: Do not stop taking Kisqali unless your doctor tells you to.
Danish: Stop ikke med at tage Kisqali, medmindre lægen har bedt dig om det.
English: Some side effects could be serious Tell your doctor immediately if you get any of the following symptoms during treatment with Kisqali:
Danish: Nogle bivirkninger kan være alvorlige Fortæl det omgående til lægen, hvis du får nogen af følgende symptomer under behandlingen med Kisqali: