natgillin/translations-raw huggingface dataset:
• en type lungekræft (ikke-småcellet lungekræft), der er fremskreden, har spredt sig eller vender tilbage, og som ikke kan behandles med kirurgi, herunder tilfælde, hvor kræftcellerne har en mutation (forandring) i genet i et protein, der hedder EGFR.
• a type of lung cancer called non-small cell lung cancer when it is advanced or has spread or come back, and cannot be treated with surgery, including cases where the cancer cells have a mutation
• kræft i æggestokkene eller relaterede strukturer (æggelederen, der fører æggene fra æggestokken til livmoderen, eller bughinden, der beklæder bugvæggens inderside)
• cancer of the ovary or associated structures (the fallopian tube that carries the egg from the ovary to the womb or the peritoneum, the membrane that lines the abdomen);
Der er også udført undersøgelser, der påviser, at behandling med Mvasi frembringer samme mængde aktivt stof i kroppen som behandling med Avastin.
Studies have also shown that giving Mvasi produces similar levels of the active substance in the body to giving Avastin.
Hvis du ønsker praktisk vejledning om anvendelsen af Mvasi, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Mvasi, patients should read the package leaflet or contact their doctor or pharmacist.
De mest alvorlige bivirkninger er huller i tarmvæggen, blødning og blodpropper i arterierne.
The most serious side effects are gastrointestinal perforation (hole in the gut wall), haemorrhage (bleeding) and arterial thromboembolism (blood clots in the arteries).
Hvilke fordele viser undersøgelserne, at der er ved Mvasi?
What benefits of Mvasi have been shown in studies?
Den fuldstændige liste over indberettede bivirkninger ved Mvasi fremgår af indlægssedlen.
For the full list of all side effects reported with Mvasi, see the package leaflet.
• nyrekræft (nyrecellekarcinom), der er fremskreden, eller som har spredt sig
• cancer of the kidney (renal cell carcinoma) that is advanced or has spread elsewhere;
VEGF's effekt standses, når Mvasi binder sig til VEGF.
By attaching to VEGF, Mvasi stops it having an effect.
Hvordan anvendes Mvasi?
How is Mvasi used?
Hvordan virker Mvasi?
How does Mvasi work?
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Mvasi.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mvasi have been included in the summary of product characteristics and the package leaflet.
Mvasi leveres som et koncentrat, der opblandes til en opløsning, som indgives via drop i en blodåre.
Mvasi is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
• livmoderhalskræft, der er vedvarende eller vender tilbage efter behandling, eller som har spredt sig til andre dele af kroppen.
• cancer of the cervix (the neck of the womb) that has persisted or come back after treatment, or spread to other parts of the body.
• kræft i tyktarmen eller endetarmen, som har spredt sig til andre dele af kroppen
• cancer of the colon (large bowel) or the rectum, when it has spread to other parts of the body;
Dette sammendrag blev sidst ajourført i 01-2017.
This summary was last updated in 01-2017.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tivicay den 16. januar 2014.
The European Commission granted a marketing authorisation valid throughout the European Union for Tivicay on 16 January 2014.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Tivicay.
This is a summary of the European public assessment report (EPAR) for Tivicay.
Den fuldstændige EPAR og resuméet af risikostyringsplanen for Tivicay findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR and risk management plan summary for Tivicay can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Tivicay fås som tabletter (10 mg, 25 mg og 50 mg).
Tivicay is available as tablets (10, 25 and 50 mg).
To undersøgelser omfattede patienter, der ikke tidligere var blevet behandlet for hiv:
Two studies involved patients who had not previously been treated for HIV:
Tivicay blev påvist at være effektivt mod hiv-1 i fire hovedundersøgelser omfattende voksne patienter.
Tivicay was demonstrated to be effective against HIV-1 in four main studies in adults.
Andre oplysninger om Tivicay
Other information about Tivicay
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Tivicay opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Tivicay's benefits are greater than its risks and recommended that it be approved for use in the EU.
Lægemidlet var sædvanligvis veltolereret, skønt CHMP bemærkede den mulige risiko for ikke almindelige, men svære overfølsomhedsreaktioner.
The medicine was generally well tolerated, although the CHMP noted the possible risk of infrequent but severe hypersensitivity reactions.
Desuden kan det være nødvendigt at tilpasse dosis af Tivicay ved samtidig anvendelse af visse lægemidler.
In addition, the dose of Tivicay may need to be adjusted if certain medicines are taken at the same time.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tivicay?
What measures are being taken to ensure the safe and effective use of Tivicay?
De hyppigste bivirkninger ved Tivicay (som optræder hos mere end 1 ud af 10 personer) er kvalme, diarré og hovedpine.
The most common side effects with Tivicay (which may affect more than 1 in 10 people) are nausea (feeling sick), diarrhoea, and headache.
Dette antivirale lægemiddel blokerer enzymet integrase, som hivvirus behøver for at danne nye kopier af sig selv i kroppen.
This is an antiviral medicine that blocks an enzyme called integrase that is needed by the HIV virus to make new copies of itself in the body.
Tivicay helbreder ikke hivinfektion eller aids, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
Tivicay does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Til de mere alvorlige bivirkninger hører en ikke almindelig, men svær overfølsomhedsreaktion (allergisk reaktion) med udslæt og mulig påvirkning af leveren.
More serious adverse effects that have been reported include an uncommon but severe hypersensitivity (allergic) reaction with rash and possible effects on the liver.
Det anvendes sammen med andre lægemidler til behandling af voksne og af børn fra 6-årsalderen, som er smittet med humant immundefektvirus type 1 (hiv-1).
It is used together with other medicines to treat adults and children from 6 years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Patienterne blev behandlet med en kombination af hivlægemidler, der omfattede enten Tivicay eller raltegravir.
Patients were treated with a combination of HIV medicines that included either Tivicay or raltegravir.
Dosis til voksne afhænger af, om infektionen vides eller antages at være resistent mod lægemidler af den klasse, som Tivicay tilhører (integrasehæmmere).
The adult dose depends on whether the infection is known or suspected to be resistant to medicines of the class to which Tivicay belongs (integrase inhibitors).
Tivicay er et antiviralt lægemiddel, der indeholder det aktive stof dolutegravir.
Tivicay is an antiviral medicine containing the active substance dolutegravir.
Tivicay må ikke gives sammen med dofetilid, et lægemiddel mod forstyrrelser i hjerterytmen, da dette kan medføre svære bivirkninger.
Tivicay must not be given together with dofetilide, a medicine for disturbances of heart rhythm, as it may cause serious side effects.
Udvalget konkluderede, at lægemidlets effektivitet var påvist hos både ubehandlede og tidligere behandlede patienter, herunder dem med resistens over for integrasehæmmere.
The Committee concluded that the medicine had demonstrated its effectiveness in both untreated and previously treated patients, including those with resistance to integrase inhibitors.
• 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.
• 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.
Hvorfor blev Tivicay godkendt?
Why is Tivicay approved?
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.
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.
Hvad er Tivicay, og hvad anvendes det til?
What is Tivicay and what is it used for?
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.
For more information about treatment with Tivicay, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Det aktive stof i Tivicay, dolutegravir, er en integrasehæmmer.
The active substance in Tivicay, dolutegravir, is an integrase inhibitor.
Dataene viste, at børn producerede de samme mængder af lægemidlet som voksne og unge, hvilket skulle resultere i en tilsvarende effektivitet.
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.
Tivicay udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af hivinfektion.
Tivicay can only be obtained with a prescription and should be prescribed by a doctor who is experienced in managing HIV infection.
Underbyggende data fra en igangværende undersøgelse blandt børn og unge viser, at unge kan få samme dosis af Tivicay som voksne.
Supportive data from an ongoing study in children and adolescents indicated that adolescents could be given the adult dose of Tivicay.
Når Tivicay gives sammen med andre lægemidler, nedsætter det spredningen af hiv og holder mængden af virus i blodet nede.
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.
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.
Response rate at 48 weeks was 71% in patients given treatment based on Tivicay, and 64% in those given treatment based on raltegravir.
To andre undersøgelser vedrørte effektiviteten af Tivicay hos patienter, hvis tidligere hivbehandling ikke længere virkede.
Two other studies looked at the effectiveness of Tivicay in patients whose previous HIV treatment had stopped working:
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.
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.
Det er ikke en praktisk vejledning i, hvordan Tivicay bør anvendes.
It is not intended to provide practical advice on how to use Tivicay.
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.
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.
• 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.
• 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.
Hvilke risici er der forbundet med Tivicay?
What are the risks associated with Tivicay?
Den fuldstændige liste over indberettede bivirkninger ved Tivicay fremgår af indlægssedlen.
For the full list of all side effects reported with Tivicay, see the package leaflet.
Hvis du ønsker praktisk vejledning om anvendelsen af Tivicay, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Tivicay, patients should read the package leaflet or contact their doctor or pharmacist.
Hvordan anvendes Tivicay?
How is Tivicay used?
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.
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.
Hos børn på 12 år og derover er normaldosen én tablet a 50 mg om dagen.
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.
Hvilke fordele viser undersøgelserne, at der er ved Tivicay?
What benefits of Tivicay have been shown in studies?
• 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).
• 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.
Hvordan virker Tivicay?
How does Tivicay work?
• Hos patienter, hvis virus ikke er resistent over for integrasehæmmere, er den normale dosis én tablet a 50 mg dagligt.
• 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.
børn i alderen 6-12 år, hvis dosis af Tivicay var baseret på deres legemsvægt.
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.
• 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).
• 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.
• Hos patienter, hvis virus vides eller antages at være resistent mod integrasehæmmere, er dosis én tablet a 50 mg to gange dagligt.
• 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.
1 flaske + 1 lukbar adapter
1 bottle + 1 cap adapter
MF (EU)-nummer
EU (MA) Number (Invented) name
Oral eller gastrointestinal anvendelse
Oral liquid Oral or gastroenteral use bottle (glass) 25 ml
Oral væske
Immediate Packaging
Dato for første markedsføringstilladelse: 28 september 2009 Dato for seneste fornyelse: 14 maj 2014
Date of first authorisation: 28/9/2009 Date of latest renewal: 14 May 2014
Visse andre lægemidler kan påvirke brugen af Zyllt eller omvendt.
Some other medicines may influence the use of Zyllt or vice versa.
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).
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).
Brug af Zyllt sammen med mad og drikke Zyllt kan tages med eller uden mad.
Zyllt with food and drink Zyllt may be taken with or without food.
Cellulose, mikrokrystallinsk Pregelatineret majsstivelse Macrogol 6000
Cellulose, microcrystalline Pregelatinised maize starch Macrogol 6000
• hvis du har haft en blodprop i en åre (arterie) i hjernen (iskæmisk apopleksi), inden for de seneste 7 dage
• if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days
• Hvis du lider af alvorlig leversygdom
• If you suffer from severe liver disease.
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
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
Din læge bør have udskrevet Zyllt plus acetylsalicylsyre, hvis du ikke må tage ”orale antikoagulantia”, og du ikke har risiko for alvorlig blødning.
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.
Zyllt indeholder clopidogrel og tilhører en lægemiddelgruppe, der kaldes blodfortyndende medicin.
Zyllt contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Hypromellose (E464) Titandioxid (E171) Rød jernoxid (E172) Talcum
Film coating Hypromellose (E464) Titanium dioxide (E171) Red iron oxide (E172) Talc
Równoległa 5, 02-235 Warszawa, Polen KRKA - FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Kroatien
Równoległa 5, 02-235 Warszawa, Poland KRKA - FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia
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.
If you experience prolonged bleeding when taking Zyllt If you cut or injure yourself, it may take longer than usual for bleeding to stop.
• Hvis du er allergisk over for clopidogrel eller et af de øvrige indholdsstoffer i Zyllt (angivet i afsnit 6)
• If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
Som forholdsregel bør amning ophøre under behandling med Zyllt.
As a precautionary measure, breast-feeding should not be continued during treatment with Zyllt.
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
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
Hvis du ønsker have yderligere oplysninger om Zyllt, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Advarsler og forsigtighedsregler Hvis nogen af følgende situationer gælder for dig, skal du oplyse det til din læge, før du tager Zyllt:
Warnings and precautions If any of the situations mentioned below apply to you, you should tell your doctor before taking Zyllt:
- Pædiatrisk population Clopidogrel bør ikke bruges til børn på grund af usikkerhed om virkningen (se pkt.
• Paediatric population Clopidogrel should not be used in children because of efficacy concerns (see section 5.1).
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.
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.
Du bør være blevet informeret om, at ”orale antikoagulantia” er mere effektive mod denne sygdom end acetylsalicylsyre eller kombinationen af Zyllt og acetylsalicylsyre.
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.
• Skal du fortælle din læge, at du er i behandling med Zyllt, hvis du skal have foretaget en planlagt operation (også hos tandlægen).
• You should tell your doctor if a surgery (including dental) is planned.
Trafik- og arbejdssikkerhed Det er usandsynligt at Zyllt påvirker din evne til at køre eller betjene maskiner.
Driving and using machines Zyllt is unlikely to affect your ability to drive or to use machines.
Derefter er den anbefalededosis én Zyllt-tabletpå75mgdagligt,som beskrevet ovenfor.
Then, the recommended dose is one 75 mg tablet of Zyllt per day as described above.
Tag ikke Zyllt
Do not take Zyllt
- 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”).
- 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').
Dumå ikke amme, når dutager denne medicin.
You should not breast-feed while taking this medicine.
Hjælpestoffer, som behandleren skal være opmærksom på Hver filmovertrukken tablet indeholder 108,125 mg lactose.
Excipients with known effect: Each film-coated tablet contains 108.125 mg lactose.
Hvis du bliver gravid, mens du tager Zyllt, skal du omgående kontakte din læge, da det frarådes at tage Zyllt under graviditet.
If you become pregnant while taking Zyllt, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Indeholder lactose.
It also contains lactose.