FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee concluded that the medicine had demonstrated its effectiveness in both untreated and previously treated patients, including those with resistance to integrase inhibitors.
Danish: Udvalget konkluderede, at lægemidlets effektivitet var påvist hos både ubehandlede og tidligere behandlede patienter, herunder dem med resistens over for integrasehæmmere.
English: • The first of these involved 715 patients whose previous treatment had not included an integrase inhibitor and whose infection was therefore not expected to be resistant to this class of medicines.
Danish: • Den første omfattede 715 patienter, hvis tidligere behandling ikke havde omfattet en integrasehæmmer, og hvis infektion derfor ikke forventedes at være resistent over for denne klasse lægemidler.
English: Why is Tivicay approved?
Danish: Hvorfor blev Tivicay godkendt?
English: The main measure of effectiveness in all the studies was the response rate, which was the proportion of patients with a reduction of the levels of virus (viral load) in the blood to fewer than 50 copies of HIV-1 RNA per ml.
Danish: I alle undersøgelserne var hovedeffektmålet responsraten, dvs. den andel af patienter, der fik reduceret virusindholdet i blodet til færre end 50 kopier af hiv-1-RNA pr. ml.
English: What is Tivicay and what is it used for?
Danish: Hvad er Tivicay, og hvad anvendes det til?
English: For more information about treatment with Tivicay, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Tivicay, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The active substance in Tivicay, dolutegravir, is an integrase inhibitor.
Danish: Det aktive stof i Tivicay, dolutegravir, er en integrasehæmmer.
English: The results indicated that similar levels of the medicine were produced in children to those seen in adults and adolescents, which should result in similar effectiveness.
Danish: Dataene viste, at børn producerede de samme mængder af lægemidlet som voksne og unge, hvilket skulle resultere i en tilsvarende effektivitet.
English: Tivicay can only be obtained with a prescription and should be prescribed by a doctor who is experienced in managing HIV infection.
Danish: Tivicay udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af hivinfektion.
English: Supportive data from an ongoing study in children and adolescents indicated that adolescents could be given the adult dose of Tivicay.
Danish: Underbyggende data fra en igangværende undersøgelse blandt børn og unge viser, at unge kan få samme dosis af Tivicay som voksne.
English: When it is given with other medicines, Tivicay helps to prevent the spread of HIV and keep the amount of the virus in the blood at a low level.
Danish: Når Tivicay gives sammen med andre lægemidler, nedsætter det spredningen af hiv og holder mængden af virus i blodet nede.
English: Response rate at 48 weeks was 71% in patients given treatment based on Tivicay, and 64% in those given treatment based on raltegravir.
Danish: Responsraten ved 48 uger var 71 % hos de patienter, hvis behandling var baseret på Tivicay, og 64 % hos de, hvis behandling var baseret på raltegravir.
English: Two other studies looked at the effectiveness of Tivicay in patients whose previous HIV treatment had stopped working:
Danish: To andre undersøgelser vedrørte effektiviteten af Tivicay hos patienter, hvis tidligere hivbehandling ikke længere virkede.
English: The response rate at 48 weeks was 88% (364 of 414 patients) in those given Tivicay-based treatment compared with 81% (338 of 419 patients) in those given Atripla.
Danish: Responsraten ved 48 uger var 88 % (364 af 414) hos de patienter, der fik en behandling baseret på Tivicay, sammenholdt med 81 % (338 af 419) hos de, der fik Atripla.
English: It is not intended to provide practical advice on how to use Tivicay.
Danish: Det er ikke en praktisk vejledning i, hvordan Tivicay bør anvendes.
English: Although Tivicay can normally be taken with or without food, patients whose virus is resistant to this class of medicines should take Tivicay with food as it helps the medicine to get absorbed.
Danish: Selv om Tivicay normalt kan tages enten sammen med et måltid eller mellem måltiderne, bør det af patienter, hvis virus er resistent over for denne klasse af lægemidler, tages sammen med et måltid, da dette forbedrer optagelsen af lægemidlet.
English: • The second study involved 833 patients given either a combination of Tivicay with two NRTIs or a different three-drug combination (Atripla) that did not include an integrase inhibitor.
Danish: • Den anden undersøgelse omfattede 833 patienter, der fik enten en kombination af Tivicay med to NRTI'er eller en anden kombination af tre lægemidler (Atripla), som ikke omfattede en integrasehæmmer.
English: What are the risks associated with Tivicay?
Danish: Hvilke risici er der forbundet med Tivicay?
English: For the full list of all side effects reported with Tivicay, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Tivicay fremgår af indlægssedlen.
English: For practical information about using Tivicay, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Tivicay, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Tivicay used?
Danish: Hvordan anvendes Tivicay?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tivicay have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Tivicay.
English: The dose for children 6 to 12 years old depends on the weight of the child; for those aged 12 and over it is usually one 50-mg tablet a day.
Danish: Hos børn på 12 år og derover er normaldosen én tablet a 50 mg om dagen.
English: What benefits of Tivicay have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Tivicay?
English: • The second study in previously treated patients involved 183 patients with infection resistant to previous treatment that had involved an integrase inhibitor (i.e. their infection was resistant to several classes of medicine, including previous integrase inhibitors): adding Tivicay twice daily to other treatment resulted in a response rate of 69% after 24 weeks of therapy.
Danish: • Den anden undersøgelse hos tidligere behandlede patienter omfattede 183 patienter med infektion, der var resistent over for tidligere behandling, som havde indbefattet en integrasehæmmer (dvs. deres infektion var resistent over for flere klasser lægemidler, herunder de tidligere integrasehæmmere).
English: How does Tivicay work?
Danish: Hvordan virker Tivicay?
English: • In patients whose virus is not resistant to integrase inhibitors, the usual dose is one 50-mg tablet a day; however, when given with certain medicines that decrease the effectiveness of Tivicay the dose is increased to one 50 mg tablet twice a day.
Danish: • Hos patienter, hvis virus ikke er resistent over for integrasehæmmere, er den normale dosis én tablet a 50 mg dagligt.
English: The company subsequently presented available results in 23 children from 6 to less than 12 years of age, who were given doses of Tivicay based on their body weight.
Danish: børn i alderen 6-12 år, hvis dosis af Tivicay var baseret på deres legemsvægt.
English: • In the first of these, involving 822 patients, Tivicay once daily was compared with raltegravir (another integrase inhibitor), both given in combination with two other HIV medicines of a different class (known as nucleoside reverse transcriptase inhibitors or NRTIs): 88% (361 of 411 patients) given Tivicay and 85% (351 of 411) given raltegravir responded after 48 weeks of treatment.
Danish: • I den første af disse, der omfattede 822 patienter, blev Tivicay, givet én gang dagligt, sammenlignet med raltegravir (en anden integrasehæmmer), idet begge lægemidler blev givet i kombination med to andre hivlægemidler af en anden klasse (nukleosidreverse transkriptasehæmmere eller NRTI'er).
English: • The dose is one 50-mg tablet twice a day in patients whose virus is known or suspected to be resistant to integrase inhibitors; in these patients, giving Tivicay with medicines that decrease its effectiveness should be avoided.
Danish: • Hos patienter, hvis virus vides eller antages at være resistent mod integrasehæmmere, er dosis én tablet a 50 mg to gange dagligt.
English: 1 bottle + 1 cap adapter
Danish: 1 flaske + 1 lukbar adapter
English: EU (MA) Number (Invented) name
Danish: MF (EU)-nummer
English: Oral liquid Oral or gastroenteral use bottle (glass) 25 ml
Danish: Oral eller gastrointestinal anvendelse
English: Immediate Packaging
Danish: Oral væske
English: Date of first authorisation: 28/9/2009 Date of latest renewal: 14 May 2014
Danish: Dato for første markedsføringstilladelse: 28 september 2009 Dato for seneste fornyelse: 14 maj 2014
English: Some other medicines may influence the use of Zyllt or vice versa.
Danish: Visse andre lægemidler kan påvirke brugen af Zyllt eller omvendt.
English: Their frequency is defined using the following conventions: 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), not known (cannot be estimated from the available data).
Danish: Hyppighed defineres i henhold til følgende konvention: almindelig (>1/100 til <1/10), ikke almindelig (>1/1.000 til <1/100), sjælden (>1/10.000 til <1/10.000), meget sjælden <1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Zyllt with food and drink Zyllt may be taken with or without food.
Danish: Brug af Zyllt sammen med mad og drikke Zyllt kan tages med eller uden mad.
English: Cellulose, microcrystalline Pregelatinised maize starch Macrogol 6000
Danish: Cellulose, mikrokrystallinsk Pregelatineret majsstivelse Macrogol 6000
English: • if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days
Danish: • hvis du har haft en blodprop i en åre (arterie) i hjernen (iskæmisk apopleksi), inden for de seneste 7 dage
English: • If you suffer from severe liver disease.
Danish: • Hvis du lider af alvorlig leversygdom
English: 7 film-coated tablets: EU/1/09/553/001 14 film-coated tablets: EU/1/09/553/002 28 film-coated tablets: EU/1/09/553/003 30 film-coated tablets: EU/1/09/553/004 50 film-coated tablets: EU/1/09/553/005 56 film-coated tablets: EU/1/09/553/006 60 film-coated tablets: EU/1/09/553/007 84 film-coated tablets: EU/1/09/553/008 90 film-coated tablets: EU/1/09/553/009 100 film-coated tablets: EU/1/09/553/010
Danish: 7 filmovertrukne tabletter: EU/1/09/553/001 14 filmovertrukne tabletter: EU/1/09/553/002 28 filmovertrukne tabletter: EU/1/09/553/003 30 filmovertrukne tabletter: EU/1/09/553/004 50 filmovertrukne tabletter: EU/1/09/553/005 56 filmovertrukne tabletter: EU/1/09/553/006 60 filmovertrukne tabletter: EU/1/09/553/007 84 filmovertrukne tabletter: EU/1/09/553/008 90 filmovertrukne tabletter: EU/1/09/553/009 100 filmovertrukne tabletter: EU/1/09/553/010
English: Your doctor should have prescribed Zyllt plus acetylsalicylic acid if you cannot take ‘oral anticoagulants' and you do not have a risk of major bleeding.
Danish: Din læge bør have udskrevet Zyllt plus acetylsalicylsyre, hvis du ikke må tage ”orale antikoagulantia”, og du ikke har risiko for alvorlig blødning.
English: Zyllt contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Danish: Zyllt indeholder clopidogrel og tilhører en lægemiddelgruppe, der kaldes blodfortyndende medicin.
English: Film coating Hypromellose (E464) Titanium dioxide (E171) Red iron oxide (E172) Talc
Danish: Hypromellose (E464) Titandioxid (E171) Rød jernoxid (E172) Talcum
English: Równoległa 5, 02-235 Warszawa, Poland KRKA - FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia
Danish: Równoległa 5, 02-235 Warszawa, Polen KRKA - FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Kroatien
English: If you experience prolonged bleeding when taking Zyllt If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Danish: Hvis du får langvarige blødninger, mens du tager Zyllt Hvis du skærer dig eller kommer til skade, kan det tage lidt længere end normalt, før blødningen stopper.
English: • If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
Danish: • Hvis du er allergisk over for clopidogrel eller et af de øvrige indholdsstoffer i Zyllt (angivet i afsnit 6)
English: As a precautionary measure, breast-feeding should not be continued during treatment with Zyllt.
Danish: Som forholdsregel bør amning ophøre under behandling med Zyllt.
English: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 60 film-coated tablets 84 film-coated tablets 90 film-coated tablets 100 film-coated tablets
Danish: 7 filmovertrukne tabletter 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 50 filmovertrukne tabletter 56 filmovertrukne tabletter 60 filmovertrukne tabletter 84 filmovertrukne tabletter 90 filmovertrukne tabletter 100 filmovertrukne tabletter
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker have yderligere oplysninger om Zyllt, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Warnings and precautions If any of the situations mentioned below apply to you, you should tell your doctor before taking Zyllt:
Danish: Advarsler og forsigtighedsregler Hvis nogen af følgende situationer gælder for dig, skal du oplyse det til din læge, før du tager Zyllt:
English: • Paediatric population Clopidogrel should not be used in children because of efficacy concerns (see section 5.1).
Danish: - Pædiatrisk population Clopidogrel bør ikke bruges til børn på grund af usikkerhed om virkningen (se pkt.
English: If you forget to take a dose of Zyllt, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Danish: Hvis du glemmer at tage en dosis af Zyllt, men kommer i tanke om det i løbet af 12 timer, skal du omgående tage tabletten og dernæst tage den næste tablet til sædvanlig tid.
English: You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Zyllt and acetylsalicylic acid for this condition.
Danish: Du bør være blevet informeret om, at ”orale antikoagulantia” er mere effektive mod denne sygdom end acetylsalicylsyre eller kombinationen af Zyllt og acetylsalicylsyre.
English: • You should tell your doctor if a surgery (including dental) is planned.
Danish: • Skal du fortælle din læge, at du er i behandling med Zyllt, hvis du skal have foretaget en planlagt operation (også hos tandlægen).
English: Driving and using machines Zyllt is unlikely to affect your ability to drive or to use machines.
Danish: Trafik- og arbejdssikkerhed Det er usandsynligt at Zyllt påvirker din evne til at køre eller betjene maskiner.
English: Then, the recommended dose is one 75 mg tablet of Zyllt per day as described above.
Danish: Derefter er den anbefalededosis én Zyllt-tabletpå75mgdagligt,som beskrevet ovenfor.
English: Do not take Zyllt
Danish: Tag ikke Zyllt
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 ‘Warnings and precautions').
Danish: - 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 ”Advarsler og forsigtighedsregler”).
English: You should not breast-feed while taking this medicine.
Danish: Dumå ikke amme, når dutager denne medicin.
English: Excipients with known effect: Each film-coated tablet contains 108.125 mg lactose.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver filmovertrukken tablet indeholder 108,125 mg lactose.
English: If you become pregnant while taking Zyllt, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Danish: Hvis du bliver gravid, mens du tager Zyllt, skal du omgående kontakte din læge, da det frarådes at tage Zyllt under graviditet.
English: It also contains lactose.
Danish: Indeholder lactose.
English: - The other ingredients are lactose (see section 2 ‘Zyllt contains lactose'), microcrystalline cellulose, pregelatinised maize starch, macrogol 6000 and hydrogenated castor oil in the tablet core and hypromellose (E464), titanium dioxide (E171), red iron oxide (E172), talc and propylene glycol in the film-coating.
Danish: - Øvrige indholdsstoffer: lactose (se afsnit 2 ”Zyllt indeholder lactose”), mikrokrystallinsk cellulose, pregelatineret majsstivelse, macrogol 6000, hydrogeneret ricinusolie i tabletkernen og hypromellose (E464), titandioxid (E171), rød jernoxid (E172), talcum og propylenglycol i filmovertrækket.
English: • You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘POSSIBLE SIDE EFFECTS').
Danish: • skal du også fortælle det til din læge med det samme, hvis du udvikler en medicinsk tilstand (trombocytisk trombocytopenisk purpura eller TTP)der giver feber og blå mærker under huden, der kan fremstå som små røde prikker, med eller uden uforklarlig ekstrem træthed, forvirring, gulning af huden eller øjnene (gulsot) (se afsnit 4 ”Bivirkninger”).
English: Other medicines and Zyllt
Danish: Brug af anden medicin sammen med Zyllt
English: This leaflet was last revised in MM/YYYY.
Danish: Denne indlægsseddel blev senest godkendt MM/ÅÅÅÅ
English: Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate).
Danish: Hver filmovertrukken tablet indeholder 75 mg clopidogrel (som hydrogensulfat).
English: България КРКА България ЕООД
Danish: КРКА България ЕООД Teл.
English: While you are taking Zyllt:
Danish: Mens du er i behandling med Zyllt:
English: If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Zyllt.
Danish: Hvis du mener, at ovenstående gælder for dig, eller hvis du overhovedet er i tvivl, så rådfør dig med din læge, inden du tager Zyllt.
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excl. heparin, ATC code: B01AC-04.
Danish: Farmakoterapeutisk klassifikation: Antithrombosemidler, trombocytfunktionshæmmende midler eksklusive heparin, ATC-kode: B01A C04.
English: Blister of OPA/Alu/PVC-Alu containing 7, 14, 28, 30, 50, 56, 60, 84, 90 and 100 film-coated tablets in the box.
Danish: Blisterkort af OPA/Al/PVC-Al i æsker med 7, 14, 28, 30, 50, 56, 60, 84, 90 og 100 filmovertrukne tabletter.
English: Boxes of 7, 14, 28, 30, 50, 56, 60, 84, 90 and 100 film-coated tablets in blisters are available.
Danish: Æsker med 7, 14, 28, 30, 50, 56, 60, 84, 90 og 100 filmovertrukne tabletter i blisterpakning.
English: If you forget to take Zyllt
Danish: Hvis du har glemt at tage Zyllt
English: Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Danish: Hvis du har taget for meget Zyllt Kontakt din læge eller nærmeste skadestue, på grund af den øgede blødningsrisiko..
English: The active metabolite is formed mostly by CYP2C19 with contributions from several other CYP enzymes, including CYP1A2, CYP2B6 and CYP3A4.
Danish: Den aktive metabolit dannes hovedsageligt af CYP2C19 med bidrag fra flere andre CYP-enzymer, inklusive CYP1A2,
English: Thrombotic Thrombocytopenic Purpura (TTP) has been reported very rarely following the use of clopidogrel, sometimes after a short exposure.
Danish: Trombotisk trombocytopenisk purpura (TTP) er indberettet i meget sjældne tilfælde hos patienter behandling med clopidogrel, enkelte gange efter kort tids brug.
English: If you stop taking Zyllt
Danish: Hvis du holder op med at tage Zyllt
English: If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Zyllt in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Danish: Hvis du har haft alvorlige smerter i brystet (hjertekrampe (ustabil angina pectoris) eller hjerteanfald), kan din læge ordinere Zyllt i kombination med acetylsalicylsyre, som er et stof, der indgår i mange typer medicin til smertelindring og febersænkning.
English: Clopidogrel should be given as a single daily dose of 75 mg.
Danish: - Voksne og ældre Clopidogrel bør gives som en enkelt daglig dosis på 75 mg.
English: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘POSSIBLE SIDE EFFECTS').
Danish: Hvis du er bekymret over din blødning, skal du omgående kontakte din læge (se afsnit 4 ”Bivirkninger”).
English: You should take Zyllt for as long as your doctor continues to prescribe it.
Danish: Du skal fortsætte med at tage Zyllt, så længe udskriver det dig.
English: By preventing this clumping, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis).
Danish: Ved at forhindre denne sammenklumpning nedsætter et blodpropopløsende præparat, der opløser blodpropper, risikoen for, at der dannes blodpropper (en proces, der kaldes trombose).
English: • if you have kidney or liver disease
Danish: • hvis du lider af en nyre- eller leversygdom
English: • For more than 12 hours: patients should take the next dose at the regular scheduled time and should not double the dose.
Danish: - Mere end 12 timer efter planlagt administration: patienten skal tage næste dosis som planlagt og ikke tage dobbelt dosis.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid till lægen eller apotekspersonalet, hvis du tager anden, for nylig har taget anden medicin eller planlægger at tage anden medicin.
English: If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Zyllt.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager Zyllt.
English: Zyllt is taken by adults 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: Zyllt tages af voksne 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. apopleksi, hjerteanfald og død (aterotrombotiske hændelser).