FrancophonIA/ELRC3.0 huggingface dataset:
English: These medicines can include: - erythromycin (used to treat infections); - midazolam (a medicine to sedate you when you e.g. undergo endoscopic procedures); - nifedipine (used to treat high blood pressure); - alfentanil, fentanyl (opioid analgesic used to treat pain); - dihydroergotamine, ergotamine (used to treat migraine); - pimozide (used to treat mental disorders); - quinidine (used to treat heart diseases); - sirolimus, tacrolimus (immunosuppressant used for the control of body's immune response).
Danish: Disse lægemidler kan omfatte: - erythromycin (bruges til behandling af infektioner) - midazolam (et lægemiddel, der bruges til bedøvelse for eksempel i forbindelse med kikkert undersøgelser) - nifedipin (bruges til behandling af forhøjet blodtryk) - alfentanil, fentanyl (opioide analgetika, der bruges til behandling af smerter) - dihydroergotamin, ergotamin (bruges til behandling af migræne) - pimozid (bruges til behandling af psykiske lidelser) - kinidin (bruges til behandling af hjertesygdomme) - sirolimus, tacrolimus (lægemidler, der undertrykker immunsystemet - bruges til regulering af kroppens immunreaktion)
English: The proportion of patients who were global symptom responders was statistically significantly higher than placebo for Truberzi 100 mg twice daily over 6 month interval in Study 2 and numerically higher than placebo in Study 1.
Danish: Andelen af patienter, der var respondenter med forbedring i globale symptomer, var statistisk signifikant højere for Truberzi 100 mg to gange dagligt end for placebo i intervallet på 6 måneder i studie 2 og numerisk højere end for placebo i studie 1.
English: Eluxadoline is a substrate of the hepatic efflux transporter MRP2.
Danish: Eluxadolin er substrat for levereffluxtransportøren MRP2.
English: Upon administration of multiple oral doses twice daily, there was no accumulation of active substance.
Danish: Der var ingen akkumulering af det aktive stof efter gentagen administration af orale doser to gange dagligt.
English: Package leaflet: Information for the patient Truberzi 100 mg film-coated tablets
Danish: Indlægsseddel: Information til patienten Truberzi 100 mg filmovertrukne tabletter
English: It is a substrate and an inhibitor of the hepatic uptake transporter OATP1B1; and a substrate for the hepatic efflux transporter MRP2.
Danish: Det er substrat for og hæmmer af leveroptagelsestransportøren OATP1B1 og substrat for levereffluxtransportøren MRP2.
English: Truberzi 75 mg film-coated tablets Each film-coated tablet contains 75 mg of eluxadoline.
Danish: Truberzi 75 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 75 mg eluxadolin.
English: The binding affinity (Ki) of eluxadoline for human κOR has not been determined; however, the Ki for guinea pig cerebellum κOR is 55 nM.
Danish: Eluxadolins bindingsaffiniteter (Ki) til human μOR og δOR er henholdsvis 1,8 nM og 430 nM. Eluxadolins bindingsaffinitet (Ki) til human κOR er ikke fastlagt, men Ki for marsvins cerebellum-κOR er 55 nM.
English: Placebo n=427
Danish: Place bo n=427
English: Pack sizes of 28, 56 and a multipack containing 168 (3 packs of 56) film-coated tablets.
Danish: Pakningsstørrelser med 28, 56 og multipakninger, der indeholder 168 (3 pakninger med 56 i hver) filmovertrukne tabletter.
English: Rash5
Danish: Udslæt5
English: Avoid use with other drugs that may cause constipation (see section 4.5).
Danish: Undgå anvendelse sammen med andre lægemidler, der kan forårsage obstipation (se pkt.
English: Modified capsule-shaped, pink-orange to peach film-coated tablet of approximately 8 mm x 19 mm, debossed with “FX100” on one side.
Danish: Modificeret kapselformet pink-orange til ferskenfarvet filmovertrukket tablet på cirka 8 mm x 19 mm med “FX100” præget på den ene side.
English: Stop taking Truberzi and seek medical attention immediately if you develop any of the following while taking this medicine: - new or worsening pain in the belly, with or without nausea and vomiting;
Danish: Hold op med at tage Truberzi og søg straks læge, hvis du får et eller flere af følgende symptomer, mens du tager dette lægemiddel: - nye smerter eller forværring af smerter i maveregionen, eventuelt samtidig med kvalme og opkastning
English: Package leaflet: Information for the patient Truberzi 75 mg film-coated tablets
Danish: Indlægsseddel: Information til patienten Truberzi 75 mg filmovertrukne tabletter
English: Overall, there was an increased frequency of adverse events reported for patients aged 65 years or greater in the clinical studies.
Danish: I de kliniske studier blev bivirkninger samlet set rapporteret med en øget hyppighed hos patienter ≥ 65 år.
English: Film-coated tablets Multipack: 168 (3 packs of 56) tablets.
Danish: Filmovertrukne tabletter Multipakning: 168 (3 pakninger med 56 i hver) tabletter.
English: In ESRD participants not yet on dialysis relative to matched, healthy participants with normal renal function, eluxadoline plasma Cmax was 2.2-fold higher and AUC0-t was 4.2-fold higher.
Danish: Hos deltagere med ESRD, der endnu ikke var i dialyse, var eluxadolins plasma-Cmax 2,2 gange højere og AUC0-t 4,2 gange højere end hos tilsvarende, raske deltagere med normal nyrefunktion.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 100 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton - 100 mg
English: Effect of OATP1B1 transporter function variability on plasma levels The plasma levels in patients with a genetic predisposition for poor function of OATP1B1 transporter are increased, and in these patients a higher rate of adverse events, especially with regard to gastrointestinal events, as well as CNS effects might be expected (see section 5.2).
Danish: Indvirkning på plasmaniveauet på grund af variationer i OATP1B1-transportørens funktion Plasmaniveauet er forhøjet hos patienter, der er genetisk disponerede for ringe funktion af OATP1B1transportøren, og hos disse patienter kan der forventes en øget hyppighed af bivirkninger, især bivirkninger i mave-tarm-kanalen og CNS (se pkt.
English: Co-administration of eluxadoline with cyclosporine (an OATP1B1 inhibitor) increased eluxadoline exposure by approximately 5-fold (see sections 4.3 and 4.5).
Danish: Samtidig indgift af eluxadolin og ciclosporin (en OATP1B1-hæmmer) øgede eluxadolins eksponering cirka 5 gange (se pkt.
English: The proportion of patients who were adequate relief responders was statistically significantly higher than placebo for Truberzi 100 mg twice daily over 6 month interval in both studies.
Danish: Andelen af patienter, der var respondenter med tilstrækkelig lindring, var statistisk signifikant højere for Truberzi 100 mg to gange dagligt end for placebo i 6 måneders intervallet i begge studier.
English: Iron oxide red (E172).
Danish: Rød jernoxid (E 172)
English: Bile acid malabsorption
Danish: Galdesyremalabsorption
English: 5 “Rash" term includes: dermatitis, dermatitis allergic, rash, rash generalized, rash macula-papular, rash papular, rash pruritic, urticaria, and idiopathic urticarial.
Danish: 5Termen “udslæt" omfatter: dermatitis, allergisk dermatitis, udslæt, generaliseret udslæt, makulopapuløst udslæt, papuløst udslæt, kløende udslæt, urticaria og idiopatisk urticaria.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 75 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton - 75 mg
English: The film-coated tablets are modified capsule-shaped, pink-orange to peach and debossed with ‘FX100' on one side.
Danish: De filmovertrukne tabletter er modificeret kapselformede, pink-orange til ferskenfarvet og præget med ‘FX100' på den ene side.
English: Modified capsule-shaped, pale yellow to light-tan film-coated tablet of approximately 7 mm x 17 mm, debossed with “FX75” on one side.
Danish: Modificeret kapselformet lysegul til lysebrun filmovertrukket tablet på cirka 7 mm x 17 mm med “FX75” præget på den ene side.
English: In vitro studies demonstrated that eluxadoline was stable in human hepatocytes, liver and intestinal microsomes, and that the only minor and inactive metabolite of eluxadoline detected was the acyl glucuronide metabolite (M11) formed through glucuronidation of the methoxybenzoic acid moiety.
Danish: Den eneste metabolit af eluxadolin, som blev påvist, var den ubetydelige og inaktive acylglukuronidmetabolit (M11), der dannes ved glukuronisation af methoxybenzoesyre-delen.
English: During the 4 week single-blind withdrawal period in Study 2 (IBS-3002), no evidence of rebound diarrhoea or abdominal pain was demonstrated.
Danish: Der blev ikke påvist nogen tegn på rebound diaré eller abdominalsmerter i den 4 ugers enkeltblinde seponeringsperiode i studie 2 (IBS-3002).
English: These patients are at risk for significantly increased plasma concentrations of eluxadoline (see sections 4.4 and 5.2).
Danish: Disse patienter har forhøjet risiko for at få signifikant forhøjet plasmakoncentration af eluxadolin (se pkt.
English: Stop taking Truberzi, and seek medical attention immediately if you have new or worsening stomach pain, with or without nausea and vomiting, while taking Truberzi.
Danish: Hold op med at tage Truberzi og søg straks læge, hvis der opstår nye smerter eller en forværring af smerter i maveregionen, eventuelt samtidig med kvalme og opkastning, mens du tager Truberzi.
English: Eluxadoline is a substrate of the hepatic uptake transporter OATP1B1.
Danish: Eluxadolin er substrat for leveroptagelsestransportøren OATP1B1.
English: There is an increased risk of pancreatitis with or without sphincter of Oddi spasm (see section 4.3) in patients taking eluxadoline.
Danish: Der er en øget risiko for pancreatitis med eller uden spasme i sphincter Oddi (se pkt.
English: How to take Truberzi
Danish: Sådan skal du tage Truberzi
English: These patients are at increased risk for sphincter of Oddi spasm (see section 4.4).
Danish: Disse patienter har øget risiko for spasmer i sphincter Oddi (se pkt.
English: MRP2 inhibitors
Danish: MRP2-hæmmere
English: If any of the above applies to you, tell your doctor or pharmacist before taking Truberzi.
Danish: Fortæl det til lægen eller apotekspersonalet, før du tager Truberzi, hvis noget af ovenstående gælder for dig.
English: Abdominal pain2
Danish: Kvalme Abdominalsmerter2
English: Therefore, eluxadoline is contraindicated in this population as well as in those with previous biliary tract problems (see sections 4.2, 4.3 and 4.4).
Danish: Eluxadolin er derfor kontraindiceret i denne population og til patienter med tidligere galdevejsproblemer (se pkt.
English: Systemic exposure to medicinal products metabolised by CYP3A4 may be decreased when coadministered with Eluxadoline.
Danish: Samtidig indgift af eluxadolin kan nedsætte den systemiske eksponering for lægemidler, der metaboliseres af CYP3A4.
English: The plasma levels in patients with a genetic predisposition for poor function of OATP1B1 transporter are increased and in these patients a higher rate of adverse events, especially with regard to gastrointestinal events, as well as CNS effects might be expected (see section 4.4).
Danish: Plasmaniveauet er forhøjet hos patienter, der er genetisk disponerede for ringe funktion af OATP1B1transportøren, og hos disse patienter kan der forventes en øget hyppighed af bivirkninger, især bivirkninger i mave-tarm-kanalen og CNS (se pkt.
English: These medicines can include: - ciclosporin (immunosuppressant used to reduce inflammation); - gemfibrozil (used to lower lipid levels); - atazanavir, lopinavir, ritonavir, saquinavir, tipranavir (antiretrovirals used to treat HIV); - rifampicin (antibiotic used to treat infections).
Danish: Disse midler kan omfatte: - ciclosporin (et lægemiddel, der undertrykker immunsystemet - bruges til behandling af betændelseslignende tilstande) - gemfibrozil (bruges til at nedsætte blodets indhold af fedtstoffer) - atazanavir, lopinavir, ritonavir, saquinavir og tipranavir (antiretrovirale midler, der bruges til behandling af hiv-infektion) - rifampicin (antibiotikum, der bruges til behandling af infektioner) Lad være med at tage Truberzi sammen med nogen af ovenstående lægemidler.
English: The film-coated tablets are modified capsule-shaped, pale yellow to light-tan and debossed with ‘FX75' on one side.
Danish: De filmovertrukne tabletter er modificeret kapselformede, lysegule til lysebrune og præget med ‘FX75' på den ene side.
English: Due to events of somnolence and sedation observed in clinical studies, caution should be exercised (see sections 4.4 and 4.5).
Danish: Der skal udvises forsigtighed, da der er observeret døsighed og sedation i kliniske studier (se pkt.
English: Abdominal Pain Response
Danish: Respons, abdominalsmerter
English: EU/1/16/1126/001 56 film-coated tablets EU/1/16/1126/002 28 film-coated tablets
Danish: EU/1/16/1126/001 56 filmovertrukne tabletter EU/1/16/1126/002 28 filmovertrukne tabletter
English: Also, eluxadoline significantly improves patients quality of life as demonstrated by change from baseline score in the IBS-QOL questionnaire at weeks 12 and 26.
Danish: Dette er vist ved en ændring i scoren på spørgeskemaet IBS-QOL i forhold til baseline i uge 12 og 26.
English: In patients with IBS-D, no signal for central nervous system-mediated adverse events was identified.
Danish: Der blev ikke observeret tegn på CNS-medierede bivirkninger hos patienter med IBS-D.
English: EU/1/16/1126/003 56 film-coated tablets EU/1/16/1126/004 28 film-coated tablets
Danish: EU/1/16/1126/003 56 filmovertrukne tabletter EU/1/16/1126/004 28 filmovertrukne tabletter
English: OATP1B1 poor function haplotypes
Danish: Haplotyper med ringe funktion af OATP1B1
English: (called ‘IBS with constipation' [IBS-C]); - if you have, or may have, a blockage in your intestine/bowels; - If you take medicines that may increase the level of the concentration of eluxadoline in the blood (so-called OATP1B1 inhibitor, e.g. ciclosporin).
Danish: - hvis du har en leversygdom og nedsat leverfunktion - hvis du har haft forstoppelse i et stykke tid, eller hvis forstoppelse er dit mest fremtrædende symptom på IBS (kaldes for ‘IBS med forstoppelse' [IBS-C]) - hvis du har eller kan tænkes at have en blokering i tarmene - hvis du tager medicin, som kan øge indholdet af eluxadolin i blodet (såkaldte OATP1B1
English: Truberzi 75 mg film-coated tablets
Danish: Truberzi 75 mg filmovertrukne tabletter
English: Truberzi 75 mg film-coated tablets.
Danish: Truberzi 75 mg filmovertrukne tabletter.
English: Truberzi 100 mg film-coated tablets
Danish: Truberzi 100 mg filmovertrukne tabletter
English: Truberzi 100 mg film-coated tablets.
Danish: Truberzi 100 mg filmovertrukne tabletter.
English: There is a potential for increased risk of somnolence and sedation when taking eluxadoline (see section 4.8) in patients who may experience increased plasma levels, such as in patients with a genetic predisposition for poor function of OATP1B1 transporter.
Danish: 4.8) hos patienter, der kan få forhøjet plasmaniveau, for eksempel patienter, der er genetisk disponerede for ringe funktion af OATP1B1-transportøren.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX - MULTIPACK ONLY) - 75 mg
Danish: RKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ETIKET (MED BLÅ BOKS - KUN MULTIPAKNING)- 75 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX - MULTIPACK ONLY) - 100 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ETIKET (MED BLÅ BOKS - KUN MULTIPAKNING) - 100 mg
English: Iron oxide yellow (E172);
Danish: Gul jernoxid (E 172)
English: Polyvinyl alcohol (E1203);
Danish: Magnesiumstearat (E 572) Polyvinylalkohol (E 1203) Titandioxid (E 171)
English: EU/1/16/1126/006 168 film-coated tablets (3 packs of 56)
Danish: EU/1/16/1126/006 168 filmovertrukne tabletter (3 pakninger med 56 i hver)
English: EU/1/16/1126/005 168 film-coated tablets (3 packs of 56)
Danish: EU/1/16/1126/005 168 filmovertrukne tabletter (3 pakninger med 56 i hver)
English: Silicified microcrystalline cellulose (E460); Colloidal anhydrous silica (E551);
Danish: Silicificeret mikrokrystallinsk cellulose (E 460) Kolloid vandfri silica (E 551) Crospovidon type B (E 1202) Mannitol (E 421)
English: If you take more Truberzi than you should
Danish: Hvis du har taget for meget Truberzi
English: Sphincter of Oddi spasm
Danish: Spasmer i sphincter Oddi
English: Eluxadoline increases the exposure of the co-administered OATP1B1 substrate; rosuvastatin (see section 5.2) by up to 40% of the total exposure which is usually not considered to be clinically relevant.
Danish: 5.2) med op til 40 % af den samlede eksponering, hvilket normalt ikke anses for at være klinisk relevant.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON (WITHOUT BLUE BOX - MULTIPACK ONLY) - 75 mg
Danish: RKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MELLEMLIGGENDE KARTON (VEDLIGEHOLDELSESPAKNING UDEN BLÅ BOKSKUN MULTIPAKNING) - 75 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON (WITHOUT BLUE BOX - MULTIPACK ONLY) - 100 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MELLEMLIGGENDE KARTON (VEDLIGEHOLDELSESPAKNING UDEN BLÅ BOKSKUN MULTIPAKNING) - 100 mg
English: Packaging
Danish: Intramuskulær
English: separate needle
Danish: 2 separate nåle
English: 0.5 ml (10 µ/ml) 1 vial
Danish: 0,5 ml (10 µ/ml)
English: 1 pre-filled syringe with 2 separate needles
Danish: 1 fyldt injektionssprøjte med 2 separate nåle
English: 0.5 ml (10 µg/ml) 1 vial + 1 syringe + 1 needle
Danish: 1 hætteglas + 1 injektionssprøjte + 1 nål
English: 0.5 ml (10 µg/ml) 10 vials
Danish: Fyldt injektionssprøjte 1 ml (10 µg/ml)
English: Content (concentration)
Danish: (glas)
English: on 18 May 2011.
Danish: den 18. maj 2011.
English: can be given to the following groups of patients:
Danish: kan gives til følgende patientgrupper:
English: Previously known as Zopya.
Danish: 1 Tidligere kendt som Zopya.
English: is one 75 mg tablet once a day, taken with or without food.
Danish: er 75 mg en gang dagligt med eller uden et måltid.
English: The European Commission granted a marketing authorisation valid throughout the EU for Zopya on 21 September 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zopya den 21. september 2009.
English: can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: is a ‘generic medicine'.
Danish: er et ‘generisk lægemiddel'.
English: It is available as pink, round tablets (75 mg).
Danish: Det fås som lyserøde, runde tabletter (75 mg).
English: can be started between a few days and 35 days after the attack;
Danish: kan påbegyndes få dage efter anfaldet og indtil 35 dage efter
English: can be started between seven days and six months after the stroke;
Danish: kan påbegyndes 7 dage efter slagtilfældet og indtil 6 måneder efter
English: For more information about treatment with Clopidogrel Krka d.d., read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Clopidogrel Krka d.d., kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Clopidogrel Krka d.d.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Clopidogrel Krka d.d..
English: is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Danish: er identisk med et referencelægemiddel, der allerede er godkendt i Den Europæiske Union, kaldet Plavix.
English: The CHMP concluded that, in accordance with EU requirements, Clopidogrel Krka d.d.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Clopidogrel Krka d.d.
English: is a medicine that contains the active substance clopidogrel.
Danish: er et lægemiddel, der indeholder det aktive stof clopidogrel.
English: This is a summary of the European public assessment report (EPAR) for Clopidogrel Krka d.d.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Clopidogrel Krka d.d.
English: • patients with peripheral arterial disease (problems with blood flow in the arteries).
Danish: • patienter med perifere kredsløbsforstyrrelser (problemer med blodgennemstrømningen i arterierne).
English: is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Danish: anvendes til forebyggelse af aterotrombotiske hændelser hos voksne (problemer forårsaget af blodpropper og åreforkalkning).
English: been approved?
Danish: godkendt?
English: is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Danish: er et generisk lægemiddel, der er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Danish: er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Plavix.
English: has been shown to have comparable quality and to be bioequivalent to Plavix.
Danish: er af sammenlignelig kvalitet og er bioækvivalent med Plavix.
English: The name of the medicine was changed to Clopidogrel Krka d.d.
Danish: Lægemidlets navn blev ændret til Clopidogrel Krka d.d.
English: What are the benefits and risks of Clopidogrel Krka d.d.
Danish: Hvilken fordel og risiko er der forbundet med Clopidogrel Krka d.d.
English: The active substance in Clopidogrel Krka d.d., clopidogrel, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Clopidogrel Krka d.d., clopidogrel, er en trombocytfunktionshæmmer.
English: used for?
Danish: til?
English: Other information about Clopidogrel Krka d.d.
Danish: Andre oplysninger om Clopidogrel Krka d.d.
English: The full EPAR for Clopidogrel Krka d.d.
Danish: Den fuldstændige EPAR for Clopidogrel Krka d.d.
English: The standard dose of Clopidogrel Krka d.d.
Danish: Standarddosis af Clopidogrel Krka d.d.
English: This means that Clopidogrel Krka d.d.
Danish: Det betyder, at Clopidogrel Krka d.d.
English: What is Clopidogrel Krka d.d.
Danish: Hvad er Clopidogrel Krka d.d.
English: The Committee recommended that Clopidogrel Krka d.d.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Clopidogrel Krka d.d..
English: Why has Clopidogrel Krka d.d.
Danish: Hvorfor blev Clopidogrel Krka d.d.
English: How does Clopidogrel Krka d.d.
Danish: Hvordan virker Clopidogrel Krka d.d.
English: 3 in subsequent cycles.
Danish: 3 i efterfølgende cykluser.
English: Wait an additional week
Danish: Vent en yderligere uge
English: The use of gloves is required.
Danish: Anvendelse af handsker er påkrævet.
English: These effects may occur early on in treatment.
Danish: Disse virkninger kan forekomme tidligt i behandlingen.
English: 20 months.
Danish: 20 måneder.
English: Three cases were poorly documented and were excluded from the assessment.
Danish: Tre af tilfældene var dårligt dokumenterede og blev udelukket fra vurderingen.
English: The frequencies are provided according to the following convention:
Danish: Hyppighed angives i henhold til følgende konvention:
English: These effects have been seen frequently, and are sometimes severe.
Danish: Disse reaktioner er set hyppigt, og er sommetider alvorlige.
English: Date of first authorisation: 21 June 1996 Date of lastest renewal: 19 May 2006
Danish: Dato for første markedsføringstilladelse: 21. juni 1996 Dato for seneste fornyelse: 19. maj 2006
English: No dosage adjustments.
Danish: Ingen dosisjustering.
English: * Measured at the end of a 30-minute infusion
Danish: *Målt ved afslutningen af en 30 minutters infusion