FrancophonIA/ELRC3.0 huggingface dataset:
English: • The Committee therefore considered that patients exposed to the above mentioned products and concomitant intake of alcohol are at significantly greater risk of developing serious adverse reactions such as respiratory depression and death, and took the view that the risk-benefit balance of the product is not positive under normal conditions of use.
Danish: • Udvalget var derfor af den opfattelse, at patienter, som eksponeres for ovennævnte lægemidler og samtidig indtager alkohol, har en væsentlig større risiko for at udvikle alvorlige bivirkninger, såsom respirationsdepression eller død, og konkluderede derfor, at benefit/risk-forholdet for lægemidlet ikke er positivt under normale anvendelsesbetingelser.
English: • Based on the published literature, a significant percentage of the patient population using these products does not abstain from alcohol consumption despite the existing warnings and contraindications, and that therefore the existing risk minimisation measures do not adequately address the concern,
Danish: • Faglitteraturen viser, at en væsentlig procentdel af den patientpopulation, der bruger disse lægemidler, ikke afholder sig fra at indtage alkohol på trods af de eksisterende advarsler og kontraindikationer, og at de eksisterende risikominimeringsforanstaltninger derfor ikke i tilstrækkelig grad afhjælper denne betænkelighed.
English: Notification of a referral for arbitration, under Article 29(4) of Directive 2001/83/EC as amended, to the CHMP was made by Denmark on 30 October 2009.
Danish: Den 30. oktober 2009 indgav Danmark meddelelse om officiel indbringelse til voldgift, jf. artikel 29, stk. 4, i direktiv 2001/83/EF med senere ændringer, til CHMP.
English: The CHMP therefore recommended the non-renewal of the marketing authorisation in line with article 24(2) of Directive 2001/83/EC as amended.
Danish: CHMP anbefalede derfor afslag på ansøgningen om fornyelse af markedsføringstilladelsen i henhold til artikel 24, stk. 2, i direktiv 2001/83/EF med senere ændringer.
English: • The Committee therefore considered that patients exposed to the above mentioned products and concomitant intake of alcohol are at significantly greater risk of developing serious adverse
Danish: • Udvalget var derfor af den opfattelse, at patienter, som eksponeres for ovennævnte lægemidler og samtidig indtager alkohol, har en væsentlig større risiko for at udvikle alvorlige bivirkninger, såsom respirationsdepression eller død, og konkluderede derfor, at benefit/risk-forholdet for lægemidlet ikke er gunstigt under normale anvendelsesbetingelser,
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter administration af et lægemiddel, før dyret kan slagtes, og kødet kan anvendes til menneskeligt konsum.
English: In the future, if the animals are exposed to the virus or the bacteria the immune system will be able to respond more quickly.
Danish: Hvis dyret efterfølgende udsættes for virusset eller bakterien, vil immunsystemet reagere hurtigere.
English: Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger - this could result in the loss of the finger if prompt medical attention is not given.
Danish: Utilsigtet selvinjektion kan medføre svære smerter og hævelse, navnlig hvis der injiceres i et led eller en finger - dette kan medføre tab af fingeren, hvis den ikke behandles omgående.
English: Further information on Porcilis PCV M Hyo can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Yderligere information om Porcilis PCV M Hyo findes på agenturets websted under:ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The repeated dose vaccination often gave slightly better results than the single vaccination.
Danish: Vaccination i henhold til todosis-regimet gav ofte lidt bedre resultater end vaccination i henhold til enkeltdosis-regimet.
English: In three of the studies there was a third similar-sized group of pigs that were vaccinated using the two-dose schedule.
Danish: I tre af studierne var der en tredje smågrisegruppe af tilsvarende størrelse, der blev vaccineret i henhold til todosisregimet.
English: For more information about using Porcilis PCV M Hyo, see the package leaflet or contact your veterinarian or pharmacist.
Danish: For mere information om brug af Porcilis PCV M Hyo, se indlægssedlen eller kontakt dyrlægen eller apotekspersonalet.
English: • Porcine circovirus type 2 (PCV2) infections can produce clinical signs such as weight loss or failure to grow, enlarged lymph nodes, difficulty in breathing, diarrhoea, pale skin and jaundice (yellowing of the skin).
Danish: • Infektion med porcint circovirus type 2 (PCV2) kan give kliniske tegn som f.eks. vægttab eller manglende vækst, forstørrede lymfeknuder, vejrtrækningsbesvær, diarré, bleg hud og gulsot.
English: The European Medicines Agency decided that Porcilis PCV M Hyo's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Porcilis PCV M Hyo opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The vaccine is given to pigs from three days of age as two injections into the neck muscle at least 18 days apart, or from three weeks of age as a single injection into the neck muscle.
Danish: Vaccinen gives til svin fra 3-dages alderen som to injektioner i nakkemusklen med mindst 18 dages mellemrum eller fra 3-ugers alderen som en enkelt injektion i nakkemusklen.
English: • Infection with the bacterium Mycoplasma hyopneumoniae in pigs causes a disease of the airways called enzootic pneumonia.
Danish: • Infektion med bakterien Mycoplasma hyopneumoniae hos svin medfører en luftvejssygdom kaldet enzootisk pneumoni.
English: Porcilis PCV M Hyo is an emulsion containing mineral oil.
Danish: Porcilis PCV M Hyo er en emulsion, der indeholder mineralsk olie.
English: When Porcilis PCV M Hyo is given to pigs the animals' immune system recognises the virus protein and bacteria as ‘foreign' and makes antibodies against them.
Danish: Når Porcilis PCV M Hyo gives til svin, registrerer dyrenes immunsystem virusproteinet og bakterierne som "fremmede" og reagerer ved at danne antistoffer mod dem.
English: In each study around 300 suckling piglets were vaccinated once with Porcilis PCV M Hyo and a second similar-sized group of piglets received a dummy injection.
Danish: I hvert studie blev ca. 300 smågrise (pattegrise) vaccineret én gang med Porcilis PCV M Hyo, mens et tilsvarende antal smågrise fik en uvirksom injektion.
English: Porcilis PCV M Hyo received a marketing authorisation valid throughout the EU for Porcilis PCV M Hyo on 7 November 2014.
Danish: Porcilis PCV M Hyo fik en markedsføringstilladelse med gyldighed i hele EU den 7. november 2014.
English: The two-dose vaccination schedule is recommended when PCV2 and/or Mycoplasma hyopneumoniae infections occur early.
Danish: Todosis-regimet anbefales, når PCV2 og/eller Mycoplasma hyopneumoniae forekommer tidligt.
English: Porcilis PCV M Hyo is a vaccine.
Danish: Porcilis PCV M Hyo er en vaccine.
English: The most common side effect (seen in more than 1 in 10 pigs) with Porcilis PCV M Hyo is a short-lived increase in body temperature of up to 2 °C on the day of vaccination.
Danish: Den hyppigste bivirkning ved Porcilis PCV M Hyo (der kan optræde hos mere end 1 ud af 10 svin) er en kortvarig temperaturstigning på op til 2 °C på vaccinationsdagen.
English: The effectiveness of Porcilis PCV M Hyo was investigated in 10 field studies involving pig farms where signs of PCV2 and/or Mycoplasma hyopneumoniae infections had been detected.
Danish: Effekten af Porcilis PCV M Hyo blev undersøgt i 10 feltstudier med svinebedrifter, hvor der var fundet tegn på PCV2- og/eller Mycoplasma hyopneumoniae-infektion.
English: Porcilis PCV M Hyo contains the adjuvants light mineral oil and aluminium hydroxide to enhance the immune response.
Danish: Porcilis PCV M Hyo indeholder let mineralsk olie og aluminiumhydroxid (såkaldte adjuvanser) for at forstærke immunreaktionen.
English: The field studies showed that both single and repeated vaccination with Porcilis PCV M Hyo reduced PCV2 levels in the blood and the severity of lung damage (lesions) caused by Mycoplasma hyopneumoniae as well as the loss of daily weight gain during the finishing period (the fattening period prior to slaughter).
Danish: Feltstudierne viste, at vaccination med Porcilis PCV M Hyo i både enkeltdosis- og todosis-regimet reducerede PCV2-niveauet i blodet og sværhedsgraden af lungeskader (læsioner) forårsaget af Mycoplasma hyopneumoniae samt faldet i daglig tilvækst i slutfedningsperioden (opfedningsperioden inden slagtning).
English: The withdrawal period for Porcilis PCV M Hyo is zero days.
Danish: Tilbageholdelsestiden for Porcilis PCV M Hyo er nul dage.
English: Porcilis PCV M Hyo contains porcine circovirus type 2 (PCV2) subunit antigen (a protein derived from part of the virus) and an inactivated (killed) strain of Mycoplasma hyopneumoniae bacteria.
Danish: Porcilis PCV M Hyo indeholder porcint circovirus type 2 (PCV2)-subunit-antigen (et protein, der er udvundet af en del af virusset) og en inaktiveret (dræbt) stamme af bakterien Mycoplasma hyopneumoniae.
English: Porcilis PCV M Hyo is a veterinary vaccine used to protect pigs against two separate infections, caused by porcine circovirus and Mycoplasma hyopneumoniae.
Danish: Porcilis PCV M Hyo er en veterinærvaccine, der anvendes til at beskytte svin mod to forskellige infektioner forårsaget af hhv. porcint circovirus og Mycoplasma hyopneumoniae.
English: Other information about Porcilis PCV M Hyo
Danish: Andre oplysninger om Porcilis PCV M Hyo
English: Porcilis PCV M Hyo is available as an injection and can only be obtained with a prescription.
Danish: Porcilis PCV M Hyo fås som injektionsvæske og udleveres kun efter recept.
English: Why is Porcilis PCV M Hyo authorised in the EU?
Danish: Hvorfor blev Porcilis PCV M Hyo godkendt i EU?
English: Laboratory studies in pigs showed that with two-dose vaccination the vaccine had its full effect against PCV2 by 18 days after first injection and against Mycoplasma hyopneumoniae by three weeks after the second injection, whilst with single-dose vaccination the vaccine had its full effect against PCV2 by two weeks and against Mycoplasma hyopneumoniae by four weeks.
Danish: Laboratoriestudier hos svin viste, at vaccinen ved todosisregimet gav fuld beskyttelse mod PCV2 18 dage efter første injektion og mod Mycoplasma hyopneumoniae tre uger efter anden injektion, og at vaccinen ved enkeltdosis-regimet gav fuld beskyttelse mod PCV2 2 uger efter injektionen og mod Mycoplasma hyopneumoniae fire uger efter injektionen.
English: What is Porcilis PCV M Hyo and what is it used for?
Danish: Hvad er Porcilis PCV M Hyo, og hvad anvendes det til?
English: What are the risks associated with Porcilis PCV M Hyo?
Danish: Hvilke risici er der forbundet med Porcilis PCV M Hyo?
English: For both vaccination schedules protection lasts for 22 weeks after (the last) injection for PCV2 and for 21 weeks after (the last) injection for Mycoplasma hyopneumoniae.
Danish: Ved begge regimer varer beskyttelsen i 22 uger efter (sidste) injektion for PCV2 og i 21 uger efter (sidste) injektion for Mycoplasma hyopneumoniae.
English: With both vaccination schedules protection lasted 22 weeks after (the last) injection for PCV2 and 21 weeks after (the last) injection for Mycoplasma hyopneumoniae.
Danish: Ved begge regimer varede beskyttelsen i 22 uger efter (sidste) injektion for PCV2 og i 21 uger efter (sidste) injektion for Mycoplasma hyopneumoniae.
English: Porcilis PCV M Hyo (Porcine circovirus and Mycoplasma hyopneumoniae vaccine, inactivated)
Danish: Porcilis PCV M Hyo (porcint circovirus- og Mycoplasma hyopneumoniae-vaccine, inaktiveret) En oversigt over Porcilis PCV M Hyo, og hvorfor det er godkendt i EU
English: With single-dose vaccination, protection against PCV2 starts at two weeks after the injection and for Mycoplasma hyopneumoniae it starts four weeks after the injection.
Danish: Ved enkeltdosis-regimet indtræder beskyttelsen mod PCV2 2 uger efter injektionen, og beskyttelsen mod Mycoplasma hyopneumoniae indtræder 4 uger efter injektionen.
English: With two-dose vaccination, protection against PCV2 starts at 18 days after the first injection and for Mycoplasma hyopneumoniae it starts 3 weeks after the second injection.
Danish: Ved todosis-regimet indtræder beskyttelsen mod PCV2 18 dage efter første injektion, og beskyttelsen mod Mycoplasma hyopneumoniae indtræder 3 uger efter anden injektion.
English: How does Porcilis PCV M Hyo work?
Danish: Hvordan virker Porcilis PCV M Hyo?
English: How is Porcilis PCV M Hyo used?
Danish: Hvordan anvendes Porcilis PCV M Hyo?
English: What benefits of Porcilis PCV M Hyo have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Porcilis PCV M Hyo?
English: - If you are pregnant or trying to become pregnant.
Danish: - Hvis du er gravid eller forsøger at blive gravid.
English: Date of first authorisation: 11/11/2016
Danish: Dato for første markedsføringstilladelse: 11/11/2016
English: If this happens, contact your doctor immediately.
Danish: Hvis det sker, skal du straks kontakte din læge.
English: Do not use this medicine after the expiry date which is stated on the label and carton after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og kartonen efter ”EXP”.
English: About 4% of an oral dose is excreted unchanged in urine.
Danish: Ca. 4% af en oral dosis udskilles uomdannet med urinen.
English: - Severe hypotension (< 90/50 mmHg).
Danish: - Svær hypotension (< 90/50 mmHg).
English: - If you are already taking medicines for the treatment of fungal infections (such as ketoconazole,
Danish: - Hvis du allerede tager medicin til behandling af svampeinfektioner (f.eks. ketoconazol,
English: Environmental risk assessment (ERA)
Danish: Miljørisikovurdering
English: Bradycardia was reported by 3.3% of patients particularly within the first 2 to 3 months of treatment initiation.
Danish: Bradykardi rapporteredes af 3,3 % af patienterne, specielt inden for de første 2 til 3 måneders behandling.
English: Food delayed absorption by approximately 1 hour, and increased plasma exposure by 20 to 30%.
Danish: Føde forsinkede absorptionen med ca. 1 time og øgede plasmaeksponering med 20 til 30 %.
English: The total clearance is about 400 mL/min and the renal clearance is about 70 mL/min.
Danish: Total clearance er ca. 400 ml/min, og den renale clearance er ca. 70 ml/min.
English: - If you suffer from very low blood pressure.
Danish: - Hvis du lider af meget lavt blodtryk.
English: Women that need treatment with ivabradine should stop breastfeeding, and choose for another way of feeding their child.
Danish: Kvinder, der har behov for behandling med ivabradin, skal ophøre med at amme og vælge en anden form for ernæring til deres barn.
English: - If you are suffering from cardiogenic shock (a heart condition treated in hospital).
Danish: - Hvis du lider af kardiogent shock (en hjertesygdom, som skal behandles på hospital).
English: They generally occur within the first two months of treatment after which they may occur repeatedly and resolve during or after treatment.
Danish: De forekommer almindeligvis inden for de første to måneder af behandlingen, hvorefter de kan forekomme gentagne gange og forsvinde under eller efter behandlingen.
English: The absence of pharmacokinetic difference between the 2 formulations was shown in an open-label randomised two-period cross-over study in 24 adult healthy volunteers.
Danish: Fravær af farmakokinetiske forskelle mellem de to lægemiddelformuleringer blev vist i et åbent randomiseret to-perioders crossover studie hos 24 voksne raske frivillige.
English: - Barbiturates (for difficult sleeping or epilepsy).
Danish: - Barbiturater (mod søvnforstyrrelser eller epilepsi).
English: - If you suffer from symptoms of atrial fibrillation (pulse rate at rest unusually high (over 110 beats per minute) or irregular, without any apparent reason, making it difficult to measure).
Danish: - Hvis du lider af symptomer på atrieflimren (hvilepulsen er usædvanlig høj (over 110 slag i minuttet) eller uregelmæssig uden nogen tydelig grund, hvilket gør det vanskeligt at måle pulsen).
English: If any of the above applies to you, talk straight away to your doctor before or while taking Ivabradine Zentiva.
Danish: Hvis noget af ovenstående gælder for dig, skal du straks tale med din læge om det, før eller mens du tager Ivabradine Zentiva.
English: If you forget to take a dose of Ivabradine Zentiva, take the next dose at the usual time.
Danish: Hvis du glemmer at tage en dosis Ivabradine Zentiva, skal du tage den næste dosis til normal tid.
English: However, in postmarketing experience, cases of impaired driving ability due to visual symptoms have been reported.
Danish: Efter markedsføringen er der imidlertid indberettet tilfælde med nedsat køreevne på grund af synsforstyrrelser.
English: Your doctor will prescribe the right dose for you.
Danish: Din læge vil ordinere den rette dosis til dig.
English: The calendar printed on the blister containing the tablets should help you remember when you last took a tablet of Ivabradine Zentiva.
Danish: Kalenderen på blisteren, som indeholder tabletterne, skal hjælpe dig med at huske, hvornår du sidst tog en Ivabradine Zentiva-tablet.
English: OPA/Alu/PVC-Alu blisters, paper carton.
Danish: OPA/Alu/PVC-Alu blister, papkartoner.
English: Ivabradine (N = 3,241) n (%)
Danish: Ivabradin (N = 3.241) n (%)
English: If you are being treated for stable angina pectoris
Danish: Hvis du bliver behandlet for stabil angina pectoris
English: Ivabradine Zentiva is not intended for use in children and adolescents younger than 18 years.
Danish: Børn Ivabradine Zentiva er ikke beregnet til børn og unge under 18 år.
English: No data are available in patients with creatinine clearance below 15 mL/min.
Danish: Der foreligger ikke data fra patienter med kreatinin-clearance under 15 ml/min.
English: 032266 Bucharest Romania
Danish: 032266 Bucharest Rumænien
English: At higher doses, the decrease in heart rate is no longer proportional to ivabradine plasma concentrations and tends to reach a plateau.
Danish: Ved højere doser er faldet i hjertefrekvens ikke længere proportionalt med plasmakoncentrationen af ivabradin og tenderer til at nå et plateau.
English: No pharmacokinetic differences (AUC and Cmax) have been observed between elderly (≥ 65 years) or very elderly patients (≥ 75 years) and the overall population (see section 4.2).
Danish: Der er ikke observeret farmakokinetiske forskelle (AUC og Cmax) mellem ældre (≥65 år) eller gamle patienter (≥75 år) og den samlede population (se pkt.
English: Very common Luminous phenomena (phosphenes) Common
Danish: Meget almindelig Lysfænomen (fosfener, fotopsier) Almindelig
English: - If your heartbeat is exclusively imposed by your pacemaker.
Danish: - Hvis din hjerterytme udelukkende styres af en pacemaker.
English: - Sino-atrial block.
Danish: - Sinuatrialt blok.
English: They particularly occur within the first 2 to 3 months of treatment initiation.
Danish: Det forekommer især inden for de første 2 til 3 måneder efter indledning af behandlingen.
English: Your doctor will decide the right dose for you.
Danish: Din læge fastsætter den rette dosis til dig.
English: • Intravenous erythromycin (an antibiotic).
Danish: • Intravenøs erythromycin (et antibiotikum).
English: - Phenytoin (for epilepsy).
Danish: - Phenytoin (mod epilepsi).
English: - If you have symptoms such as tiredness, dizziness or shortness of breath (this could mean that your heart is slowing down too much).
Danish: - Hvis du har symptomer som træthed, svimmelhed eller kortåndethed (det kan betyde, at dit hjerte slår for langsomt).
English: Under physiological conditions, ivabradine is rapidly released from tablets and is highly water-soluble (> 10 mg/mL).
Danish: Under fysiologiske betingelser frigøres ivabradin hurtigt fra tabletterne og er letopløseligt i vand (>10 mg/ml).
English: - Unstable or acute heart failure.
Danish: - Ustabil eller akut hjerteinsufficiens.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet.
English: Ivabradine 5 mg twice daily was shown to be effective on exercise test parameters within 3 to 4 weeks of treatment.
Danish: Ivabradin 5 mg to gange dagligt viste sig at være effektivt på arbejdstestparametre i løbet af 3 til 4 ugers behandling.
English: • Bepridil (to treat angina pectoris).
Danish: • Bepridil (til behandling af angina pectoris).
English: If you still have angina symptoms and if you have tolerated the 5 mg twice daily dose well, the dose may be increased.
Danish: Hvis du stadig har symptomer på angina, og hvis du har tålt dosis på 5 mg to gange dagligt godt, kan dosis øges.
English: - If you have heart failure which has recently become worse.
Danish: - Hvis du lider af hjertesvigt, og din tilstand for nylig er forværret.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ivabradine in all subsets of the paediatric population for the treatment of angina pectoris.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med ivabradin i alle undergrupper af den pædiatriske population til behandling af angina pectoris.
English: Tablets must be taken orally twice daily, i.e. once in the morning and once in the evening during meals (see section 5.2).
Danish: Tabletterne skal tages per os to gange dagligt, dvs. en tablet om morgenen og en om aftenen i forbindelse med et måltid (se pkt.
English: The following adverse reactions have been reported during clinical trials and are ranked using the following frequency: very common (≥ 1/10); 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: I de kliniske studier er der rapporteret om følgende bivirkninger, som er opstillet efter hyppighed i henhold til denne konvention: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: - If you are a woman able to have children and not using reliable contraception.
Danish: - Hvis du er en kvinde i den fødedygtige alder og ikke anvender sikker prævention.
English: Ivabradine Zentiva mainly works by reducing the heart rate by a few beats per minute.
Danish: Ivabradine Zentiva virker hovedsageligt ved at nedsætte hjertefrekvensen med nogle få slag pr. minut.
English: - If your resting heart rate before treatment is too slow (below 70 beats per minute).
Danish: - Hvis din hjertefrekvens i hvile før behandlingen er for langsom (under 70 slag i minuttet).
English: This leaflet was last revised in <{MM/YYYY}>
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}
English: mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin).
Danish: mefloquin, halofantrin, pentamidin, cisaprid og intravenøst erythromycin).
English: If this happens to you, be careful when driving or using machines at times when there could be sudden changes in light intensity, especially when driving at night.
Danish: Hvis du får det, skal du udvise forsigtighed, når du kører bil eller betjener maskiner, specielt på tidspunkter, hvor der kan forekomme pludselige ændringer i lysintensiteten, især ved nattekørsel.