FrancophonIA/ELRC3.0 huggingface dataset:
English: Pack sizes of 14, 28, 56; 168 modified-release tablets and 32 x 1modified-release tablets in a perforated unit dose blister.
Danish: Pakningsstørrelser à 14, 28, 56, 168 tabletter med modificeret udløsning og 32 x 1 tabletter med modificeret udløsning i perforeret enkeltdosisblister.
English: • anxiety
Danish: • Besvimelse
English: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Danish: Brug af anden medicin sammen med Trevaclyn Fortæl altid lægen eller på apoteket, hvis De bruger anden medicin eller har gjort det for nylig.
English: Common: abdominal pain; diarrhoea; dyspepsia; nausea; vomiting Rare: mouth oedema; eructation; peptic ulcer
Danish: Mave-tarmkanalen: Mavesmerter, ødem i munden, opstød, ulcus pepticum.
English: Respiratory, thoracic, and mediastinal disorders
Danish: Luftveje, thorax og mediastinum: Dyspnø.
English: Safety and effectiveness of Trevaclyn in paediatric patients under the age of 18 years have not been established.
Danish: Trevaclyn bør ikke anvendes til pædiatriske patienter under 18 år p.g.a. manglende dokumentation for sikkerhed og virkning.
English: Not known: jaundice
Danish: Lever og galdeveje: Icterus
English: NAME OF THE MEDICINAL PRODUCT Trevaclyn 1,000 mg/20 mg modified-release tablets Nicotinic acid/laropiprant
Danish: Trevaclyn 1.000 mg/20 mg tabletter med modificeret udløsning Nicotinsyre/laropiprant
English: Merck Sharp & Dohme s.r.o.
Danish: Česká republika Merck Sharp & Dohme s.r.o.Tel.
English: Common: headache; paraesthesia Uncommon: dizziness Rare: migraine; syncope
Danish: Infektioner og parasitære sygdomme: Rhinitis.
English: What Trevaclyn is and what it is used for What you need to know before you take Trevaclyn How to take Trevaclyn
Danish: Det skal De vide, før De begynder at tage Trevaclyn Sådan skal De tage Trevaclyn Bivirkninger
English: What Trevaclyn contains
Danish: Trevaclyn indeholder:
English: Rare: rhinitis
Danish: Meget almindelig
English: Uncommon: hypersensitivity reaction (see below) Rare: angio-oedema; type I hypersensitivity Not known: anaphylactic shock
Danish: Immunsystemet: Anafylaktisk shock, angioødem, type-1 overfølsomhed.
English: Other medicines and Trevaclyn
Danish: Samlede bivirkninger ved Trevaclyn
English: If you take more Trevaclyn than you should
Danish: Hvis De har taget for meget Trevaclyn
English: EU/1/08/458/014 32 x 1modified-release tablets
Danish: EU/1/08/458/009 14 tabletter med modificeret udløsning EU/1/08/458/010 28 tabletter med modificeret udløsning EU/1/08/458/011 56 tabletter med modificeret udløsning EU/1/08/458/013 168 tabletter med modificeret udløsning EU/1/08/458/014 32 x 1 tabletter med modificeret udløsning
English: • whole body rash
Danish: • Udslæt over hele kroppen
English: Summary of the safety profile
Danish: Oversigt over indlægssedlen:
English: • sleeplessness
Danish: • Nældefeber
English: Metabolism and nutrition disorders
Danish: BILAG I PRODUKTRESUME
English: Package size bottle (HDPE)
Danish: flaske (HDPE)
English: Strength Pharmaceutical Form Route of administration
Danish: Lægemiddelform Indgivelsesvej Emballering
English: Packaging
Danish: Pakkestr.
English: This summary was last updated in May 2015.
Danish: Dette sammendrag blev senest ajourført i maj 2015.
English: Protection starts three weeks after vaccination and lasts one year.
Danish: Beskyttelsen begynder tre uger efter vaccinationen og vedvarer i et år.
English: An occasional temporary, acute (short-term) hypersensitivity (allergic) reaction may occur.
Danish: Undertiden kan der forekomme en midlertidig kortvarig (akut) allergisk reaktion.
English: The European Commission granted a marketing authorisation valid throughout the EU for Canigen L4 on 3 July 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for Canigen L4 den 3. juli 2015.
English: The full EPAR for Canigen L4 can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Canigen L4 findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Canigen L4 contains four types of inactivated (killed) Leptospira strains: L. interrogans serogroup Canicola serovar Portland-vere, L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni, L. interrogans serogroup Australis serovar Bratislava, L. kirschneri serogroup Grippotyphosa serovar Dadas.
Danish: Canigen L4 indeholder fire forskellige dræbte (inaktiverede) stammer af Leptospira: L. interrogans serogruppe Canicola serovar Portland-vere, L. interrogans serogruppe Icterohaemorrhagiae serovar Copenhageni, L. interrogans serogruppe Australis serovar Bratislava og L. kirschneri serogruppe Grippotyphosa serovar Dadas.
English: This vaccine is the same as Nobivac L4, which is already authorised in the European Union (EU).
Danish: Vaccinen er identisk med Nobivac L4, som allerede er godkendt i Den Europæiske Union (EU).
English: The bacteria are spread via the urine of infected animals.
Danish: Bakterierne spredes gennem urinen fra smittede dyr.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Canigen L4's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Canigen L4 opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: In the future, if the animals are exposed to these Leptospira bacteria the immune system will be able to respond more quickly.
Danish: Hvis dyrene efterfølgende udsættes for disse Leptospira-bakterier, vil immunsystemet reagere hurtigere.
English: Canigen L4 is a veterinary vaccine used to vaccinate dogs from six weeks of age to protect against leptospirosis caused by one of four specific types of Leptospira bacteria.
Danish: Canigen L4 er en veterinærvaccine, der anvendes til vaccination af hunde fra 6-ugers alderen for at beskytte mod leptospirose forårsaget af en af de fire særlige typer Leptospira-bakterier.
English: The company that makes Nobivac L4 has agreed that its scientific data can be used for Canigen L4 (‘informed consent').
Danish: Virksomheden, som fremstiller Nobivac L4, har indvilget i, at dens videnskabelige oplysninger må anvendes for Canigen L4 (informeret samtykke).
English: This is a summary of the European public assessment report (EPAR) for Canigen L4.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Canigen L4.
English: A mild and temporary increase in body temperature (1°C or less) may occur for a few days after vaccination, with some puppies showing less activity and/or a reduced appetite.
Danish: Der kan komme let, forbigående temperaturstigning (op til 1° C) i nogle dage efter vaccinationen, og nogle hvalpe kan have nedsat aktivitet og/eller nedsat appetit.
English: In dogs, leptospirosis can cause bleeding, hepatitis (inflammation of the liver) and jaundice (yellowing of the skin and eyes) or nephritis (kidney inflammation).
Danish: Hos hunde kan leptospirose medføre blødning, leverbetændelse (hepatitis), gulsot af hud og øjne eller nyrebetændelse (nefritis).
English: When Canigen L4 is given to dogs the animals' immune system recognises the bacteria as ‘foreign' and makes defences against them.
Danish: Når Canigen L4 gives til hunde, opfatter dyrenes immunsystem bakterierne som "fremmede" og reagerer ved at danne forsvar mod dem.
English: The studies showed that the vaccine reduces infection with Leptospira and excretion of the bacteria into the urine.
Danish: Undersøgelserne viste, at vaccinen nedsætter smitte med Leptospira og udskillelsen af bakterier i urinen.
English: The strains of Leptospira bacteria in Canigen L4 are killed (inactivated) so that they do not cause disease.
Danish: Stammerne af Leptospirabakterier i Canigen L4 er inaktiveret (dræbt), så de ikke kan forårsage sygdom.
English: Canigen L4 is a vaccine.
Danish: Canigen L4 er en vaccine.
English: This will help protect them against leptospirosis.
Danish: Derved er de bedre beskyttet mod leptospirose.
English: A small, temporary swelling may occur at the injection site, which will either disappear or reduce in size within two weeks after vaccination.
Danish: På injektionsstedet kan der forekomme forbigående let hævelse, der svinder eller aftager i løbet af to uger efter vaccinationen.
English: They also showed that the vaccine is safe to give to pregnant bitches.
Danish: De viste desuden, at vaccinen også er sikker at anvende hos drægtige tæver.
English: Canine leptospirosis vaccine (inactivated)
Danish: Leptospirosevaccine til hunde (inaktiveret)
English: The first injection can be given from six to nine weeks of age and the second four weeks later.
Danish: 9-ugers alderen, den anden 4 uger senere.
English: Canigen L4 is available as a suspension for injection and can only be obtained with a prescription.
Danish: Canigen L4 fås som injektionsvæske, suspension, og udleveres kun på recept.
English: Other information about Canigen L4
Danish: Andre oplysninger om Canigen L4
English: It is not intended to provide practical advice on how to use Canigen L4.
Danish: Det er ikke en praktisk vejledning i, hvordan Canigen L4 bør anvendes.
English: The vaccine is given to dogs as two injections, four weeks apart, under the skin.
Danish: Der gives to injektioner af vaccinen under huden på hundene med fire ugers mellemrum.
English: What is Canigen L4 and what is it used for?
Danish: Hvad er Canigen L4, og hvad anvendes det til?
English: Why is Canigen L4 approved?
Danish: Hvorfor blev Canigen L4 godkendt?
English: The company has presented data from both laboratory and field studies to establish the safety and effectiveness of the vaccine, including how long it took for the dogs to be fully protected and how long the vaccine could provide protection.
Danish: Undersøgelserne har dels skullet vise, hvor lang tid det tog, før hundene var fuldstændig beskyttet, dels hvor længe beskyttelsen varede.
English: What are the risks associated with Canigen L4?
Danish: Hvilke risici er der forbundet med Canigen L4?
English: For some strains of Leptospira, the vaccine also reduces the excretion (shedding) of the bacteria into the urine by the infected dogs, thereby reducing the risk of transmission.
Danish: For nogle stammer af Leptospira nedsætter vaccinen også udskillelsen af bakterier i urinen fra smittede hunde.
English: For more information about treatment with Canigen L4, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Canigen L4, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For practical information about using Canigen L4, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Canigen L4, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: How is Canigen L4 used?
Danish: Hvordan anvendes Canigen L4?
English: What benefits of Canigen L4 have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Canigen L4?
English: A single ‘booster' injection should be given every year to maintain the vaccine's effect.
Danish: (Disse antistoffer er en særlig type proteiner, som hvalpen får fra moderen gennem mælken, og som hjælper kroppen til at bekæmpe infektioner), Vaccinationen gentages hvert år med injektion af en enkelt "boosterdosis" for at opretholde vaccinens virkning.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom high levels of maternally derived antibodies (special type of proteins, received from the mother in the milk, that help the body to fight infection), it is recommended that the first vaccination is given at nine weeks of age.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The European Commission granted a marketing authorisation valid throughout the European Union for Otezla on 15 January 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Otezla den 15. januar 2015.
English: The medicine is available as tablets (10, 20 and 30 mg).
Danish: Lægemidlet fås som tabletter (10, 20 og 30 mg).
English: What is Otezla and what is it used for?
Danish: Hvad er Otezla, og hvad anvendes det til?
English: Other information about Otezla
Danish: Andre oplysninger om Otezla
English: The full EPAR and risk management plan summary for Otezla can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Otezla findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Treatment is started with a dose of 10 mg on day 1 and gradually increased over a week to the recommended dose of 30 mg twice a day.
Danish: Behandlingen påbegyndes med en dosis på 10 mg på dag 1, der over en uge gradvist øges til den anbefalede dosis på 30 mg to gange dagligt.
English: This is a summary of the European public assessment report (EPAR) for Otezla.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Otezla.
English: Response to treatment should be evaluated regularly and use of Otezla should be reconsidered if there is no improvement after six months.
Danish: Behandlingens virkning bør vurderes regelmæssigt, og brugen af Otezla bør tages op til revurdering, hvis der ikke er bedring efter seks måneder.
English: Otezla may be used alone or combined with other DMARDs.
Danish: Otezla kan bruges alene eller i kombination med andre DMARD.
English: A risk management plan has been developed to ensure that Otezla is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Otezla anvendes så sikkert som muligt.
English: These usually occur within the first two weeks of treatment, and get better within 4 weeks.
Danish: Disse optræder sædvanligvis i de første to uger af behandlingen og aftager i løbet af 4 uger.
English: Why is Otezla approved?
Danish: Hvorfor blev Otezla godkendt?
English: Otezla is a medicine used to treat adults with:
Danish: Otezla er et lægemiddel til behandling af voksne med:
English: Patients who were already taking other so-called ‘small-molecule DMARDs' such as the medicine methotrexate continued this treatment during the study.
Danish: Patienter, der i forvejen fik andre “lavmolekylære DMARD” såsom methotrexat, fortsatte med denne behandling under undersøgelsen.
English: What measures are being taken to ensure the safe and effective use of Otezla?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Otezla?
English: Otezla must not be used during pregnancy, and women who can become pregnant should use an effective means of contraception during treatment.
Danish: Otezla må ikke bruges under graviditet, og kvinder, som kan blive gravide, skal bruge sikker prævention under behandlingen.
English: The Committee therefore considered that it was useful as a second-line treatment in patients who do not respond to or cannot use the first-line treatments.
Danish: Udvalget fandt det derfor nyttigt som andetvalgsbehandling til patienter, hos hvem førstevalgsbehandling ikke virker eller ikke kan bruges.
English: Benefit was seen both in patients taking Otezla alone and those also taking other DMARDs.
Danish: Behandlingen fandtes at være til fordel både for de patienter, der fik Otezla alene, og dem, der også fik andre DMARD.
English: Otezla contains the active substance apremilast.
Danish: Otezla indeholder det aktive stof apremilast.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Otezla's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Otezla opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: This was achieved in between 32 and 41% of patients given the approved dose of Otezla in the three studies, compared with 18 to 19% of those given placebo.
Danish: Dette opnåedes hos 32-41 % af de patienter, der fik den godkendte dosis af Otezla i de tre undersøgelser, sammenholdt med 18-19 % af dem, der fik placebo.
English: Of the patients given Otezla in these two studies, 33% (168 of 562) and 29% (79 of 274) responded to treatment.
Danish: Af de patienter, der fik Otezla i disse to undersøgelser, virkede behandlingen henholdsvis hos 33 % (168 af 562) og 29 % (79 af 274).
English: What are the risks associated with Otezla?
Danish: Hvilke risici er der forbundet med Otezla?
English: It is not intended to provide practical advice on how to use Otezla.
Danish: Det er ikke en praktisk vejledning i, hvordan Otezla bør anvendes.
English: This compared with 5% (15 of 282) and 6% (8 of 137) given placebo.
Danish: Dette skal sammenholdes med henholdsvis 5 % (15 ud af 282) og 6 % (8 ud af 137) hos dem, der fik placebo.
English: For both psoriasis and psoriatic arthritis benefit there was evidence of maintained benefit when treatment was extended (to 32 and 52 weeks respectively).
Danish: Både ved psoriasis og psoriasisgigt holdt bedringen sig, når behandlingen blev forlænget (til henholdsvis 32 og 52 uger).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Otezla, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Otezla, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The other common side effects (which may affect up to 1 in 10 people) are upper respiratory tract infections (colds) and headaches or tension headaches.
Danish: De andre hyppige bivirkninger (som kan forekomme hos op til 1 ud af 10 personer) er forkølelse (øvre luftvejsinfektioner) og hovedpine eller spændingshovedpine.
English: For the full list of all side effects and restrictions with Otezla, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Otezla fremgår af indlægssedlen.
English: It is used in patients who have not responded to or cannot use other systemic (affecting the whole body) treatments for psoriasis, such as ciclosporin, methotrexate or PUVA (psoralen ultraviolet A).
Danish: Det anvendes hos patienter, der ikke har haft gavn af eller ikke tåler systemisk behandling (helkropsbehandling) af psoriasis med andre lægemidler såsom ciclosporin, methotrexat eller PUVA (psoralen ultraviolet-A).
English: The most common side effects with Otezla (which may affect more than 1 in 10 people) are effects on the digestive system such as diarrhoea and nausea (feeling sick).
Danish: De hyppigste bivirkninger ved Otezla (som kan forekomme hos op til 1 ud af 10 personer) er virkninger på fordøjelsessystemet såsom diarré og kvalme.
English: • active psoriatic arthritis (inflammation of the joints associated with psoriasis) in patients who cannot take or who have not responded well enough to other treatments called disease-modifying antirheumatic drugs (DMARDs).
Danish: • aktiv psoriasisgigt (inflammation i leddene i forbindelse med psoriasis) hos patienter, der ikke kan bruge eller ikke har tilstrækkelig gavn af andre lægemidler kaldet sygdomsmodificerende gigtmidler (DMARD).
English: Otezla can only be obtained with a prescription and treatment should only be started by a doctor experienced in the diagnosis and treatment of psoriasis or psoriatic arthritis.
Danish: Otezla udleveres kun efter recept, og behandlingen bør kun iværksættes af en læge med erfaring i diagnose og behandling af psoriasis eller psoriasisgigt.
English: The active substance in Otezla, apremilast, blocks the action of an enzyme inside cells called phosphodiesterase 4 (PDE4).
Danish: Det aktive stof i Otezla, apremilast, blokerer virkningen af enzymet fosfodiesterase 4 (PDE4).
English: Although the medicine had not been compared with other authorised treatments, and for psoriatic arthritis X-ray evidence of an effect on the progress of the disease was not available, the mostly mild or moderate side effects and the fact that the medicine could be taken by mouth might make it more acceptable to patients.
Danish: Selv om Otezla ikke blev sammenlignet med andre godkendte lægemidler, og der for psoriasisgigt ikke fandtes røntgenbilleder til dokumentation af den positive virkning på sygdommens udvikling, kan Otezla være mere acceptabelt for patienterne, fordi det hovedsagelig har lette til moderate bivirkninger og kan indtages gennem munden.
English: For psoriatic arthritis, Otezla has been compared with placebo in 3 main studies, involving 1,493 patients with active disease despite prior treatment.
Danish: Ved psoriasisgigt blev Otezla sammenlignet med placebo i 3 hovedundersøgelser med 1 493 patienter med aktiv sygdom trods forudgående behandling.
English: In psoriasis, Otezla has been investigated in 2 main studies involving a total of 1,257 patients with moderate to severe plaque psoriasis, in which treatment with Otezla was compared with placebo (a dummy treatment).
Danish: Ved psoriasis er Otezla undersøgt i to hovedundersøgelser med i alt 1 257 patienter med moderat til svær plaquepsoriasis, hvor behandling med Otezla blev sammenlignet med virkningsløs behandling (placebo).
English: For more information about treatment with Otezla, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Otezla, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Response to treatment was defined as patients having a 75% or more reduction in a symptom score known as Psoriasis Area Severity Index (PASI-75).
Danish: Målet for behandlingens virkning var en reduktion på mindst 75 % i patienternes symptomscore på et sværhedsindeks kaldet Psoriasis Area Severity Index (PASI-75).
English: The main measure of effectiveness in both studies was the proportion of patients who ‘responded' to treatment after 16 weeks.
Danish: I begge undersøgelser blev virkningen hovedsagelig bedømt på den andel af patienterne, hos hvem behandlingen virkede efter 16 uger.
English: The main measure of effectiveness was a 20% improvement in a score measuring symptoms such as tender and swollen joints (ACR-20) after 16 weeks of treatment.
Danish: Det vigtigste mål for virkningen var, om der efter 16 ugers behandling var 20 % bedring i symptomscore for ømme, hævede led (ACR-20).
English: PUVA is a type of treatment where the patient receives a medicine containing a compound called a ‘psoralen' before being exposed to ultraviolet light.
Danish: PUVA er en behandling, hvor patienten får medicin indeholdende stoffet psoralen, efterfulgt af behandling med ultraviolet lys,
English: What benefits of Otezla have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Otezla?
English: For practical information about using Otezla, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Otezla, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Otezla used?
Danish: Hvordan anvendes Otezla?
English: How does Otezla work?
Danish: Hvordan virker Otezla?
English: Lower doses should be given to patients with severe impairment of kidney function.
Danish: Ved svært nedsat nyrefunktion bør anvendes lavere doser.
English: The CHMP considered that benefit had been shown in psoriasis and psoriatic arthritis.
Danish: CHMP fandt det påvist, at Otezla har en positiv virkning ved psoriasis og psoriasisgigt.