FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients who develop evidence of recurrent hepatitis post-treatment, there are insufficient data on the benefits of re-initiation of lamivudine treatment.
Danish: Der er utilstrækkelige data om fordelene ved at genoptage behandling med lamivudin hos patienter, som efter behandlingsophør udvikler tegn på tilbagevendende hepatitis.
English: Don't store above 30 °C.
Danish: Må ikke opbevares ved temperaturer over 30 °C.
English: NAME OF THE MEDICINAL PRODUCT Zeffix 100 mg film-coated tablets Lamivudine
Danish: Indlægsseddel: Information til brugeren Zeffix 100 mg filmovertrukne tabletter lamivudin
English: : + 33 (0)1 39 17 84 44 diam@gsk.com
Danish: Laboratoire GlaxoSmithKline Tél: + 33 (0)1 39 17 84 44 diam@gsk.com
English: MARKETING AUTHORISATION NUMBER EU/1/99/114/003
Danish: EU/1/99/114/001 EU/1/99/114/002
English: If you take more Zeffix than you should
Danish: Hvis du har taget for meget Zeffix
English: Check with your doctor or pharmacist if you're not sure.
Danish: - Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.
English: Rash, pruritus
Danish: Udslæt, kløe
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 100 mg lamivudine
Danish: Hver filmovertrukken tablet indeholder 100 mg lamivudin
English: 1 Patients designated as YMDD mutant were those with 5% YMDD mutant HBV at any annual time-point during the 5-year period.
Danish: - Uge 260 normal over normal < baseline over normal > baseline 1 Patienter kategoriseret som havende YMDD-mutation var patienter med ≥ 5 % YMDD-mutation-HBV på ethvert årligt tidspunkt under den 5-årige studieperiode.
English: • an increase in the level of an enzyme produced in the muscles (creatine phosphokinase) which may be a sign that body tissue is damaged.
Danish: En almindelig bivirkning, som kan vise sig i blodprøver, er: stigning i indholdet af enzymer, som dannes i musklerne (kreatinfosfokinase), som kan være tegn på ødelæggelse af muskelvæv.
English: What you need to know before you take Zeffix 3.
Danish: Virkning og anvendelse Det skal du vide, før du begynder at tage Zeffix Sådan skal du tage Zeffix Bivirkninger
English: How to store Zeffix Keep this medicine out of the sight and reach of children.
Danish: Sådan skal du tage Zeffix Tag altid lægemidlet nøjagtigt efter lægens anvisning.
English: SPECIAL STORAGE CONDITIONS Do not store above 30C
Danish: Må ikke opbevares ved temperaturer over 30 °C
English: You need to be aware of the extra risks:
Danish: Du kan have behov for ekstra kontrolbesøg,
English: • lactic acidosis (excess lactic acid in the blood).
Danish: • stigning i indholdet af leverenzymer (aminotransferaser).
English: SPECIAL STORAGE CONDITIONS Do not store above 25C
Danish: Må ikke opbevares ved temperaturer over 25 °C
English: Excipient intolerance
Danish: Intolerans over for hjælpestoffer
English: This summary was last updated in December 2012.
Danish: Dette sammendrag blev sidst ajourført i december 2012.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Prac-tic to on 18 December 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Prac-tic den 18. december 2006.
English: For large dogs a combination of pipettes might be needed to achieve the correct dose.
Danish: Til store hunde kan det være nødvendigt med en kombination af pipetter for at opnå den korrekte dosis.
English: Other information about Prac-tic:
Danish: Andre oplysninger om Prac-tic:
English: This product is specifically developed for dogs and should not be used in any other animal species.
Danish: Præparatet er specielt udviklet til hunde og bør ikke anvendes til andre dyrearter.
English: Prac-tic should not be allowed to enter surface water, as it may be harmful for aquatic organisms.
Danish: Prac-tic må ikke hældes ud i overfladevand, da det kan være skadeligt for vandorganismer.
English: Two field studies were conducted in dogs at veterinary practices in several European countries and different geographic regions.
Danish: Der er blevet gennemført feltundersøgelser hos hunde på dyrlægeklinikker i en række europæiske lande og i forskellige geografiske områder.
English: As a precautionary measure, direct contact with the treated dog should be avoided and children should not be allowed to play with a treated animal until the application site is dry.
Danish: Som en sikkerhedsforanstaltning bør direkte kontakt med behandlede dyr undgås, og børn bør ikke lege med behandlede dyr, før påføringsstedet er tørt.
English: The medicine killed fleas within 24 hours and ticks within 48 hours after treatment and its effectiveness lasted for at least 4 weeks.
Danish: Lægemidlet dræbte lopperne inden for 24 timer og flåterne inden 48 timer efter behandling, og dets virkning varede ved i mindst 4 uger.
English: Prac-tic should not be used in dogs less than 8 weeks old or less than 2 kg bodyweight since it has not sufficiently been studied in these animals.
Danish: Prac-tic bør ikke anvendes til hvalpe på under 8 uger eller med en kropsvægt på under 2 kg, da der ikke er foretaget tilstrækkelige undersøgelser blandt disse.
English: Pyriprole, interacts with a receptor involved in transmitting neural impulses (GABA receptor).
Danish: Pyriprol, interagerer med en receptor, der medvirker ved udsendelsen af nerveimpulser (GABAreceptor).
English: It is given to dogs with pre-filled spot-on pipettes, i.e. small plastic containers which are already filled with the correct amount of Prac-tic needed to treat one dog (Pract-tic is available in 4 different sizes for different dog sizes).
Danish: Det gives til hunde ved hjælp af fyldte spot-on pipetter, dvs. små plasticbeholdere, som allerede indeholder den mængde Prac-tic, som er nødvendig til behandling af én hund (Prac-tic findes i fire forskellige pakningsstørrelser alt efter hundens størrelse).
English: Data were provided on the pharmaceutical quality, the tolerance of the product in dogs and the safety in humans (people in contact with the product) and the environment.
Danish: Der er forelagt oplysninger om den farmaceutiske kvalitet, om hvordan hundene tålte produktet, og om sikkerheden i forhold til mennesker (personer, der kommer i berøring med lægemidlet) og i forhold til miljøet.
English: Prac-tic is an “ectoparasiticide”, which means that it will kill parasites that live on the skin or in the fur of animals, such as fleas and ticks.
Danish: Prac-tic er et ”ektoparasitdræbende” middel, hvilket betyder, at det dræber parasitter, der lever på dyrs hud eller i dyrs pels, som f.eks. lopper og flåter.
English: As other products of this group, Prac-tic should not be used in sick animals or dogs that have just recovered from illness.
Danish: Ligesom andre præparater i denne gruppe bør Prac-tic ikke anvendes til syge dyr eller dyr, som lige er blevet raske.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Prac-tic exceed the risks for the approved indications and recommended that Prac-tic be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Prac-tic opvejer risiciene, når det anvendes ved den godkendte indikation, og anbefalede udstedelse af markedsføringstilladelse for Prac-tic.
English: People with known hypersensitivity to the phenylpyrazole class compounds or any of the excipients should avoid contact with Prac-tic.
Danish: Personer, der er overfølsomme over for phenylpyrazolforbindelser eller andre af indholdsstofferne, bør undgå at komme i berøring med Prac-tic.
English: The effectiveness was measured looking at the number of live ticks or number of fleas at various times up to 3 months after application.
Danish: Virkningen blev målt ud fra antallet af levende flåter eller lopper på forskellige tidspunkter i op til 3 måneder efter påføringen af præparatet.
English: Prac-tic is a spot-on solution that contains pyriprole as active substance.
Danish: Prac-tic er en spot-on opløsning, der indeholder det aktive stof pyriprol.
English: The most common side effects in dogs are local reactions at the place where the product has been applied: change in the fur colour, hair loss and itchiness, as well as change in appearance of the fur (greasy appearance and clumpiness).
Danish: De hyppigste bivirkninger ved Prac-tic hos hunde er lokale reaktioner på påføringsstedet: misfarvning af pelsen, hårtab, kløe og ændring af pelsens udseende (fedtet udseende eller sammenfiltring af hårene).
English: The content of the pipette is squeezed onto the skin after parting the fur in one up to three spots between the shoulder blades and down the backline of the dog.
Danish: Pelsen mellem hundens skulderblade holdes ud til siderne, og pipettens indhold påføres huden på 1-3 tre steder mellem hundens skulderblade og langs dens ryg.
English: What is the risk associated with Prac-tic?
Danish: Hvilke risici er der forbundet med Prac-tic?
English: When administering Prac-tic, the user should not smoke, eat or drink.
Danish: Den, der påfører lægemidlet, bør ikke ryge, spise eller drikke, mens produktet håndteres.
English: Once applied, it remains active for at least 4 weeks.
Danish: Lægemidlets virkning efter påføringen varer ved i mindst 4 uger.
English: Dogs from various breeds, age groups and weight that were infested with fleas or ticks were either treated with Prac-tic or with other products authorised in the EU for this indication.
Danish: Undersøgelserne omfattede forskellige racer og forskellige alders- og vægtgrupper, og de loppe- eller flåtangrebne hunde blev enten behandlet med Prac-tic eller med andre præparater, som er godkendt til denne indikation i EU.
English: The effectiveness of pyriprole against flea and tick infestations in dogs was investigated in laboratory studies and in field trials.
Danish: Pyriprols virkning mod flåt- og loppeangreb hos hunde er blevet undersøgt igennem både laboratorieundersøgelser og feltundersøgelser.
English: Why has Prac-tic been approved?
Danish: Hvorfor er Prac-tic blevet godkendt?
English: This interferes with the nervous system of fleas or ticks and leads to the death of these parasites.
Danish: Stoffet påvirker loppernes eller flåternes nervesystem og bevirker, at de dør.
English: Skin contact with the pipette content should be avoided.
Danish: Pipettens indhold bør ikke komme i kontakt med huden.
English: The results of the field trials showed that Prac-tic is effective in the treatment and prevention of flea and tick infestations in dogs.
Danish: Resultaterne af feltundersøgelserne viste, at Prac-tic er effektivt til behandling og forebyggelse af loppe- og flåtangreb hos hunde.
English: Prac-tic is used to treat and to prevent tick and flea infestations in dogs.
Danish: Prac-tic anvendes til behandling og forebyggelse af flåt- og loppeangreb hos hunde.
English: If a dog licks the application area, the dog might salivate a lot for a short period.
Danish: Hvis hunden kommer til at slikke på påføringsstedet umiddelbart efter behandlingen, kan det give anledning til kortvarig, kraftig spytafsondring.
English: Adult fleas are killed before they lay eggs; since Prac-tic completely eliminates egg production, it breaks the flea life cycle.
Danish: Da Prac-tic fuldstændig stopper loppernes produktion af æg, brydes deres livscyklus.
English: What is Prac-tic?
Danish: Hvad er Prac-tic?
English: What is Prac-tic used for?
Danish: Hvad anvendes Prac-tic til?
English: How has Prac-tic been studied?
Danish: Hvordan blev Prac-tic undersøgt?
English: What benefit has Prac-tic shown during the studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Prac-tic?
English: How does Prac-tic work?
Danish: Hvordan virker Prac-tic?
English: Skin should be washed and eyes should be rinsed with water, if accidental exposure occurred.
Danish: Hvis produktet ved et uheld kommer i kontakt med huden eller øjnene, skal huden/øjnene skylles med vand.
English: 50 x 1 tablet(unit dose) 105 tablets
Danish: 50 x 1 tabletter (unit dose)
English: Name
Danish: (Særnavn) Navn
English: This finding was based on the results from 769 patients.
Danish: Disse tal byggede på resultaterne af undersøgelserne af 769 patienter.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nexavar on 19 July 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Nexavar den 19. juli 2006.
English: The treatment is continued as long as the patient continues to benefit from it without too many side effects.
Danish: Behandlingen fortsætter, så længe patienten har fordel af den og ikke har for mange bivirkninger.
English: This is a summary of the European public assessment report (EPAR) for Nexavar.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Nexavar.
English: Nexavar is given as two tablets twice a day, without food or with a meal that is low in fat.
Danish: Nexavar gives som to tabletter to gange dagligt uden et måltid eller med et fedtfattigt måltid.
English: Other information about Nexavar
Danish: Andre oplysninger om Nexavar
English: To manage side effects, treatment may have to be temporarily interrupted or the dose may be reduced.
Danish: Visse bivirkninger kan gøre det nødvendigt at afbryde behandlingen midlertidigt eller at reducere dosen.
English: Nexavar has been compared with placebo (a dummy treatment) in three main studies.
Danish: Nexavar blev sammenlignet med placebo (en virkningsløs behandling) i tre hovedundersøgelser.
English: EPAR summary for the public sorafenib
Danish: EPAR - sammendrag for offentligheden sorafenib
English: Because the numbers of patients with these diseases are low, the diseases are considered ‘rare', and Nexavar was designated an ‘orphan medicine' (a medicine used in rare diseases).
Danish: Da antallet af patienter med disse sygdomme er lavt, betragtes sygdommene som ”sjældne”, og Nexavar er blevet udpeget som ”lægemiddel til sjældne sygdomme”.
English: Nexavar is used to treat patients who have the following diseases:
Danish: Nexavar anvendes til behandling af patienter, som har følgende sygdomme:
English: For more information about treatment with Nexavar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Nexavar, 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 Nexavar.
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, hvordan Nexavar skal anvendes.
English: • renal cell carcinoma (29 July 2004)
Danish: • renalcellekarcinom (29. juli 2004)
English: This finding was based on the results from all 903 patients, including about 200 who had switched from placebo to Nexavar before the end of the study.
Danish: Disse tal byggede på resultaterne af undersøgelserne af alle 903 patienter, inklusive de ca. 200, som havde skiftet fra placebo til Nexavar, inden undersøgelsen var afsluttet.
English: Treatment with Nexavar should be supervised by doctors who have experience of anticancer treatments.
Danish: Behandling med Nexavar bør overvåges af læger med erfaring i behandling af kræft.
English: The summaries of the opinions of the Committee for Orphan Medicinal Products for Nexavar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations:
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Nexavar findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designations:
English: • papillary thyroid cancer and follicular thyroid cancer (13 November 2013) The full EPAR for Nexavar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: • papillær thyreoideacancer og follikulær thyreoideacancer (13. november 2013) Den fuldstændige EPAR for Nexavar findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The CHMP decided that Nexavar's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Nexavar opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Nexavar.
English: By blocking these enzymes, Nexavar can reduce the growth of cancer cells and cut off the blood supply that keeps cancer cells growing.
Danish: Ved at blokere disse enzymer kan Nexavar begrænse væksten og spredningen af kræften og afskære blodforsyningen, som får kræftcellerne til at vokse.
English: The active substance in Nexavar, sorafenib, is a protein kinase inhibitor.
Danish: Det aktive stof i Nexavar, sorafenib, er en proteinkinasehæmmer.
English: • advanced renal cell carcinoma (a type of kidney cancer) when anticancer treatment with interferon alfa or interleukin 2 has failed or cannot be used;
Danish: • fremskredent renalcellekarcinom (en form for nyrekræft), når kræftbehandling med interferon alfa eller interleukin-2 ikke har virket eller ikke kan anvendes
English: • hepatocellular carcinoma (11 April 2006)
Danish: • hepatocellulært karcinom (11. april 2006)
English: For the full list of all side effects and restrictions with Nexavar, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Nexavar fremgår af indlægssedlen.
English: • hepatocellular carcinoma (a type of liver cancer);
Danish: • hepatocellulært karcinom (en form for leverkræft)
English: Nexavar is a cancer medicine that contains the active substance sorafenib.
Danish: Nexavar er et lægemiddel mod kræft, som indeholder det aktive stof sorafenib.
English: Nexavar was more effective than placebo in increasing how long the patients survived or how long the patients lived without their disease getting worse.
Danish: Nexavar var mere effektivt end placebo til at forlænge patienternes overlevelsestid, eller hvor længe patienterne levede, uden at kræften blev værre.
English: The patients taking Nexavar lived for longer without their disease getting worse (167 days, around five and a half months) than those who took placebo (84 days, around three months).
Danish: Patienterne, som fik Nexavar, levede længere, uden at deres sygdom forværredes (167 dage, ca. 5,5 måneder), end dem, der fik placebo (84 dage, ca. 3 måneder).
English: What is the risk associated with Nexavar?
Danish: Hvilken risiko er der forbundet med Nexavar?
English: The most common side effects with Nexavar are diarrhoea, rash, alopecia (hair loss), infection, hand foot skin reaction (rash and pain on the palms of the hands and soles of the feet) and fatigue (tiredness).
Danish: De hyppigste bivirkninger ved Nexavar er diarré, udslæt, hårtab, infektion, "hånd-fod-syndromet" (udslæt på og smerte i håndfladerne og fodsålerne) og træthed.
English: The most important serious side effects are myocardial infarction (heart attack) or ischaemia (reduced oxygen supply to the heart), gastrointestinal perforation (a hole that develops in the wall of the gut), drug-induced hepatitis (a disease of the liver), haemorrhage (bleeding) and hypertension or hypertensive crisis (high blood pressure).
Danish: De vigtigste og mest alvorlige bivirkninger er myokardieinfarkt (hjerteanfald) eller hjerteiskæmi (nedsat ilttilførsel til hjertemusklen), perforation af tarmen (hul i tarmvæggen), lægemiddelfremkaldt hepatitis (en sygdom i leveren), hæmoragi (blødning) og hypertension (forhøjet blodtryk) eller hypertensive kriser (blodtryksforhøjelse).
English: • differentiated thyroid carcinoma (a type of cancer originating from the follicular cells of the thyroid gland) when the cancer has progressed or spread locally or to other parts of the body and does not respond to treatment with radioactive iodine.
Danish: • differentieret thyreoideakarcinom (en form for kræft, som udgår fra de follikulære celler i skjoldbruskkirtlen), når kræften har udviklet sig yderligere eller har spredt sig lokalt eller til andre dele af kroppen og ikke mere reagerer på behandling med radioaktivt iod.
English: Why has Nexavar been approved?
Danish: Hvorfor blev Nexavar godkendt?
English: The main measures of effectiveness were how long the patients survived or how long the patients lived without their disease getting worse.
Danish: Virkningen blev hovedsagelig bedømt på, hvor længe patienterne overlevede, og hvor længe der gik, inden kræften forværredes.
English: What is Nexavar?
Danish: Hvad er Nexavar?
English: These enzymes can be found in some receptors on the surface of cancer cells, where they are involved in the growth and spread of cancer cells, and in the blood vessels that supply the tumours, where they are involved in the development of new blood vessels.
Danish: Disse enzymer findes i visse receptorer på kræftcellernes overflade, hvor de medvirker til kræftcellernes vækst og spredning.
English: In the study of hepatocellular carcinoma, the patients taking Nexavar survived for an average of 10.7 months, compared with 7.9 months in those taking placebo.
Danish: I undersøgelsen af hepatocellulært karcinom overlevede patienterne, som fik Nexavar, gennemsnitligt 10,7 måneder sammenlignet med 7,9 måneder hos dem, der fik placebo.
English: In the study in differentiated thyroid carcinoma, the patients taking Nexavar lived for an average of 10.8 months without their disease getting worse, compared with 5.8 months in those taking placebo.
Danish: I undersøgelsen af differentieret thyreoideakarcinom levede patienterne, som fik Nexavar, gennemsnitligt 10,8 måneder, uden at sygdommen forværredes, sammenlignet med 5,8 måneder hos dem, der fik placebo.
English: In the study of renal cell carcinoma, the patients taking Nexavar survived for an average of 19.3 months, compared with 15.9 months in those taking placebo.
Danish: I undersøgelsen af renalcellekarcinom overlevede patienterne, som fik Nexavar, gennemsnitligt 19,3 måneder sammenlignet med 15,9 måneder hos dem, der fik placebo.
English: What is Nexavar used for?
Danish: Hvad anvendes Nexavar til?
English: How has Nexavar been studied?
Danish: Hvordan blev Nexavar undersøgt?
English: The first study involved 602 patients with hepatocellular carcinoma; the second involved 903 patients with advanced renal cell carcinoma in whom one previous anticancer treatment had stopped working; and the third study involved 417 patients with differentiated thyroid carcinoma that had progressed or spread locally or to other parts of the body and did not respond to treatment with radioactive iodine.
Danish: Den tredje undersøgelse omfattede 417 patienter med differentieret thyreoideakarcinom, som havde udviklet sig yderligere eller spredt sig enten lokalt eller til andre dele af kroppen, og som ikke reagerede på behandling med radioaktivt iod.
English: What benefit has Nexavar shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Nexavar?
English: How is Nexavar used?
Danish: Hvordan anvendes Nexavar?
English: How does Nexavar work?
Danish: Hvordan virker Nexavar?
English: The full EPAR for Levetiracetam Actavis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Levetiracetam Actavis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam Actavis on 3 October 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Levetiracetam Actavis den 3. oktober 2011.
English: It is available as tablets (250 mg, 500 mg, 750 mg and 1,000 mg).
Danish: Det fås som tabletter ((250 mg, 500 mg, 750 mg og 1000 mg).