FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of all side effects reported with ReFacto AF, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved ReFacto AF fremgår af indlægssedlen.
English: These are known as inhibitors as they can prevent the medicine from working effectively, which may result in a loss of bleeding control.
Danish: Disse kaldes inhibitorer, da de kan forhindre lægemidlet i at virke, så blødningen ikke længere er under kontrol.
English: The studies showed that ReFacto AF was as safe and effective as ReFacto in preventing and treating bleeding episodes in patients with haemophilia A.
Danish: Undersøgelserne viste, at ReFacto AF var lige så sikker og effektiv som ReFacto til at forebygge og behandle blødningsepisoder hos patienter med hæmofili A.
English: ReFacto AF should be started under the supervision of a doctor who has experience in the treatment of haemophilia A.
Danish: Behandlingen med ReFacto AF bør indledes under overvågning af en læge med erfaring i behandling af hæmofili A.
English: ReFacto AF is used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder).
Danish: ReFacto AF anvendes til behandling og forebyggelse af blødning hos patienter med hæmofili A (en medfødt blødersygdom).
English: What is the risk associated with ReFacto AF?
Danish: Hvilken risiko er der forbundet med ReFacto AF?
English: Why has ReFacto AF been approved?
Danish: Hvorfor blev ReFacto AF godkendt?
English: ReFacto AF is a powder and solvent used to make up a solution for injection.
Danish: ReFacto AF er et pulver og en solvens, som blandes til en injektionsvæske, opløsning.
English: What benefit has ReFacto AF shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved ReFacto AF?
English: What is ReFacto AF?
Danish: Hvad er ReFacto AF?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Refacto AF have been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af ReFacto AF.
English: How has ReFacto AF been studied?
Danish: Hvordan blev ReFacto AF undersøgt?
English: What is ReFacto AF used for?
Danish: Hvad anvendes ReFacto AF til?
English: How is ReFacto AF used?
Danish: Hvordan anvendes ReFacto AF?
English: Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily and may have problems, such as bleeding in the joints, muscles and internal organs.
Danish: Som følge heraf har de nemt til at bløde og kan få problemer såsom blødning i led, muskler og indre organer.
English: It is available as vials or pre-filled syringes.
Danish: Det fås som hætteglas eller fyldte injektionssprøjter.
English: MA (EU) Number
Danish: Markedsføringstillad elsens (EU)-nummer
English: (Invented) name Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Administrationsvej(e) Indre emballage Pakningsstørrelse
English: This authorisation was based on the authorisation granted to Procoralan in 2005 (‘informed consent').
Danish: Denne tilladelse byggede på den tilladelse, som var udstedt for Procoralan i 2005 ("informeret samtykke").
English: Side effects reported with this medicine are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved dette lægemiddel vurderes omhyggeligt, og der træffes de nødvendige forholdsregler til at beskytte patienterne.
English: The main measure of effectiveness was how long patients could exercise on a bicycle or a treadmill, which was measured at the start and the end of each study.
Danish: Virkningen blev hovedsagelig målt på, hvor længe patienterne kunne motionere på en cykel eller trædemølle, målt ved begyndelsen og slutningen af hvert studie.
English: Ivabradine Anpharm received a marketing authorisation valid throughout the EU on 8 September 2015.
Danish: Ivabradine Anpharm fik en markedsføringstilladelse med gyldighed i hele EU den 8. september 2015.
English: Further information on Ivabradine Anpharm can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Ivabradine-Anpharm.
Danish: Yderligere information om Ivabradine Anpharm findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Ivabradine-Anpharm.
English: In stable angina, these symptoms appear during physical effort.
Danish: Ved ustabil angina viser disse symptomer sig under fysisk anstrengelse.
English: Ivabradine Anpharm must not be taken with a number of other medicines.
Danish: Ivabradine Anpharm må ikke tages sammen med en række andre lægemidler.
English: It must not be used in women who are pregnant, breastfeeding or by women who could become pregnant and who are not using appropriate contraceptives.
Danish: Det må ikke anvendes hos kvinder, der er gravide eller ammer, eller hos kvinder, der er i den fødedygtige alder og ikke anvender sikker prævention.
English: Ivabradine Anpharm is available as tablets (5 and 7.5 mg) and can only be obtained with a prescription.
Danish: Ivabradine Anpharm leveres som tabletter (5 og 7,5 mg) og udleveres kun efter recept.
English: For more information about using Ivabradine Anpharm, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Ivabradine Anpharm, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The main measure of effectiveness was a reduction in the risk of death due to heart problems and non-fatal heart attack.
Danish: Virkningen blev hovedsagelig målt på mindsket risiko for hjertedød og ikke-dødeligt hjerteanfald.
English: Treatment must be stopped if the heart rate is persistently below 50 beats per minute or if symptoms of bradycardia (slow heart rate) continue despite dose reduction.
Danish: Behandlingen skal standses, hvis pulsen vedholdende er lavere end 50 slag pr. minut, eller hvis den langsomme puls (bradykardi) fortsætter trods dosisnedsættelse.
English: As for all medicines, data on the use of Ivabradine Anpharm are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Ivabradine Anpharm løbende overvåget.
English: In a fourth study in 889 patients, Ivabradine Anpharm was more effective than placebo when both were added to atenolol.
Danish: I et fjerde studie med 889 patienter var Ivabradine Anpharm mere effektivt end placebo, når de begge blev tilføjet til atenolol.
English: Results showed that it was more effective than placebo at preventing death due to disease of the heart or blood vessels or hospitalisation due to worsening heart failure: 24.5% (793 out of 3,241) of patients treated with Ivabradine Anpharm died or were hospitalised due to worsening heart failure, compared with 28.7% (937 out of 3,264) of patients receiving placebo.
Danish: Resultaterne viste, at det var mere effektivt end placebo til at forebygge dødsfald som følge af sygdom i hjerte eller blodkar, eller indlæggelse pga. forværret hjertesvigt: 24,5 % (793 ud af 3.241) af de patienter, der blev behandlet med Ivabradine Anpharm, døde eller blev indlagt som følge af forværret hjertesvigt, sammenholdt med 28,7 % (937 ud af 3.264) af dem, der fik placebo.
English: However, a fifth study in 728 patients showed that adding Ivabradine Anpharm to amlodipine did not provide an additional benefit.
Danish: I et femte studie hos 728 patienter var der imidlertid ingen ekstra fordel ved at tilføje Ivabradine Anpharm til amlodipin.
English: Ivabradine Anpharm therefore reduces or prevents the symptoms of angina.
Danish: Ivabradine Anpharm nedsætter eller forhindrer derved symptomerne på angina.
English: What measures are being taken to ensure the safe and effective use of Ivabradine Anpharm?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ivabradine Anpharm?
English: It was as effective as atenolol (a beta blocker) in a study of 939 patients and as effective as amlodipine (another medicine used to treat angina) in a study of 1,195 patients.
Danish: Det var lige så effektivt som betablokkeren atenolol i et studie med 939 patienter, og lige så effektivt som et andet lægemiddel til behandling af angina (amlodipin) i et studie med 1.195 patienter.
English: The medicine is used in patients who have a normal heart rhythm and whose heart rate is at least 70 beats per minute.
Danish: Lægemidlet anvendes hos patienter med normal hjerterytme og en puls på mindst 70 pr. minut.
English: The Agency decided that Ivabradine Anpharm's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet afgjorde, at fordelene ved Ivabradine Anpharm opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Ivabradine Anpharm must not be used in patients who have a resting heart rate below 70 beats per minute, very low blood pressure, various types of heart disorder (including cardiogenic shock, rhythm disorders, heart attack, unstable or acute (sudden) heart failure and unstable angina) or severe liver problems.
Danish: Ivabradine Anpharm må ikke anvendes hos patienter med en hvilende hjertefrekvens på under 70 pr. minut, meget lavt blodtryk, forskellige hjertesygdomme (herunder kardiogent shock, rytmeforstyrrelser, hjerteanfald, ustabilt eller pludseligt (akut) hjertesvigt og ustabil angina) eller svære leverproblemer.
English: The most common side effect with Ivabradine Anpharm (which may affect more than 1 in 10 people) is luminous phenomena or ‘phosphenes' (a temporary brightness in the field of vision).
Danish: Den hyppigste bivirkning med Ivabradine Anpharm (som optræder hos mere end 1 ud af 10 patienter), er forbigående lysfornemmelser eller "fosfener” (midlertidig oplysthed i synsfeltet).
English: Also, the doctor should consider stopping treatment if the medicine has only a limited effect on reducing angina symptoms or reducing the heart rate within 3 months.
Danish: Lægen bør desuden overveje at stoppe behandlingen, hvis lægemidlet efter 3 måneder kun har en begrænset virkning på anginasymptomerne eller kun i begrænset omfang sænker pulsen.
English: By lowering the heart rate, Ivabradine Anpharm reduces the stress on the heart, thereby slowing the progression of heart failure and improving symptoms.
Danish: Ved at sænke hjertefrekvensen nedsætter Ivabradine Anpharm belastningen af hjertet og bremser dermed forløbet af hjertesvigt og giver bedring i symptomerne.
English: The recommended starting dose is 5 mg twice a day with meals, which the doctor may increase to 7.5 mg twice a day or decrease to 2.5 mg (half a 5-mg tablet) twice a day depending on the patient's heart rate and symptoms.
Danish: Dette kan af lægen sættes op til 7,5 mg to gange dagligt eller sættes ned til 2,5 mg (en halv 5 mg-tablet) to gange dagligt, afhængigt af patientens hjertefrekvens og symptomer.
English: An overview of Ivabradine Anpharm and why it is authorised in the EU
Danish: En oversigt over Ivabradine Anpharm og hvorfor det er godkendt i EU
English: The active substance in Ivabradine Anpharm, ivabradine, works by blocking the ‘If currents' in the sinus node, the natural ‘pacemaker' that controls the heart's contractions and regulates the heart rate.
Danish: Det aktive stof i Ivabradine Anpharm, ivabradin, virker ved at blokere "If-strømmene" i sinusknuden, den naturlige "pacemaker", der kontrollerer hjertets sammentrækninger og regulerer pulsen.
English: Ivabradine Anpharm contains the active substance ivabradine.
Danish: Ivabradine Anpharm indeholder det aktive stof ivabradin.
English: Ivabradine Anpharm (ivabradine)
Danish: Ivabradine Anpharm (ivabradin)
English: In this study, a specific subgroup of patients who had symptomatic angina had a small but significant increase in the combined risk of cardiovascular death or non-fatal heart attack with Ivabradine Anpharm compared with placebo (3.4% vs 2.9% yearly incidence rates).
Danish: I dette studie havde en særlig undergruppe af patienter med anginasymptomer en lille, men statistisk sikker stigning i den kombinerede risiko for hjerte-kardødelighed og ikke-dødeligt hjerteanfald, når de fik Ivabradine Anpharm, i forhold til placebo (3,4 % mod 2,9 % i årlig forekomst).
English: What is Ivabradine Anpharm and what is it used for?
Danish: Hvad er Ivabradine Anpharm, og hvad anvendes det til?
English: Ivabradine Anpharm was compared with placebo (a dummy treatment) and other treatments in five main studies involving over 4,000 adults with long-term stable angina.
Danish: Ivabradine Anpharm er blevet sammenlignet med virkningsløs behandling (placebo) og andre behandlinger i fem hovedstudier hos over 4.000 voksne med langvarig stabil angina.
English: A sixth study compared Ivabradine Anpharm with placebo in 19,102 patients with coronary artery disease and without clinical heart failure.
Danish: I et sjette studie blev Ivabradine Anpharm sammenlignet med placebo hos 19.102 patienter med koronar hjertesygdom uden klinisk hjertesvigt.
English: Other information about Ivabradine Anpharm
Danish: Andre oplysninger om Ivabradine Anpharm
English: Ivabradine Anpharm was compared with placebo in one main study involving over 6,500 patients with long-term moderate to severe heart failure.
Danish: Ivabradine Anpharm er desuden blevet sammenlignet med placebo i ét hovedstudie med over 6.500 patienter med langvarigt moderat til svært hjertesvigt.
English: Ivabradine Anpharm is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body) who have a normal heart rhythm and whose heart rate is at least 75 beats per minute.
Danish: Ivabradine Anpharm anvendes desuden hos patienter, hvis hjerte til stadighed ikke kan pumpe tilstrækkeligt med blod til resten af kroppen (kronisk hjertesvigt), og som har normal hjerterytme og en puls på mindst 75.
English: Why is Ivabradine Anpharm authorised in the EU?
Danish: Hvorfor blev Ivabradine Anpharm godkendt i EU?
English: Ivabradine Anpharm is a heart medicine used to treat the symptoms of long-term stable angina (pains to the chest, jaw and back, brought on by physical effort) in adults with coronary artery disease (disease of the heart caused by the obstruction of the blood vessels that supply blood to the heart muscle).
Danish: Ivabradine Anpharm er et lægemiddel, der anvendes mod symptomer i form af langvarige stabil angina (smerter i brystet, kæben og ryggen), som opstår ved fysisk anstrengelse hos voksne med hjertesygdom som følge af forsnævring af blodkarrene til hjertemusklen (koronararteriesygdom).
English: What are the risks associated with Ivabradine Anpharm?
Danish: Hvilke risici er der forbundet med Ivabradine Anpharm?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ivabradine Anpharm have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Ivabradine Anpharm.
English: It also concluded that Ivabradine Anpharm was effective in long-term heart failure with an acceptable safety profile.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at Ivabradine Anpharm er påvist at være effektivt ved langvarig angina og at have en acceptabel sikkerhedsprofil.
English: For the full list of restrictions with Ivabradine Anpharm, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger med Ivabradine Anpharm fremgår af indlægssedlen.
English: How is Ivabradine Anpharm used?
Danish: Hvordan anvendes Ivabradine Anpharm?
English: For the full list of all side effects reported with Ivabradine Anpharm, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Ivabradine Anpharm fremgår af indlægssedlen.
English: How does Ivabradine Anpharm work?
Danish: Hvordan virker Ivabradine Anpharm?
English: What benefits of Ivabradine Anpharm have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Ivabradine Anpharm?
English: The European Medicines Agency concluded that Ivabradine Anpharm was shown to be effective in longterm angina with an acceptable safety profile for it to provide an alternative treatment for patients who cannot take beta blockers or whose disease is not controlled with them.
Danish: Det er derfor en alternativ behandlingsmulighed for patienter, som ikke kan få betablokkere, eller hos hvem sygdommen ikke kan kontrolleres med dem. Udvalget konkluderede desuden, at Ivabradine Anpharm var effektivt ved langvarigt hjertesvigt og havde en acceptabel sikkerhedsprofil.
English: ATCvet code: QI01AD07.
Danish: ATCvet kode: QI01AD07.
English: Each dose of reconstituted vaccine contains:
Danish: Hvert dosis rekonstitueret vaccine indeholder:
English: Do not use this veterinary medicinal product after the expiry date stated on the label.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten.
English: Each container should be used immediately and completely after opening.
Danish: Hver beholder skal anvendes straks og fuldstændigt efter åbning.
English: Live IBV, 4-91
Danish: Levende IBV, 4-91
English: The same volumes as for the single product should be used.
Danish: Der skal bruges samme mængder, som gælder for anvendelse af et enkelt produkt.
English: Water withholding should be kept as short as possible with a minimum of half an hour.
Danish: Afbrydelse af vandforsyningen bør være så kort som mulig, dog minimum en halv time.
English: Date of first authorisation: 09/06/1998.
Danish: Dato for første markedsføringstilladelse: 09/06/1998.
English: In both cases mix the water containing the vaccine well before use.
Danish: I begge tilfælde blandes vandet indeholdende vaccinen grundigt inden brug.
English: For prolonged immunity, chickens should be revaccinated every 6 weeks after the initial administration.
Danish: For at opnå forlænget immunitet bør kyllinger revaccineres hver 6. uge efter første vaccination.
English: In post marketing experience: In very rare cases mild respiratory signs of disease are reported.
Danish: Post marketing erfaring: I meget sjældne tilfælde er milde, respiratoriske symptomer på sygdom rapporteret.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of their territory if it is established that:
Danish: I henhold til artikel 71 i Europa-Parlamentets og Rådets direktiv 2001/82/EF, med senere ændringer, kan en medlemsstat i overensstemmelse med medlemsstatens nationale lovgivning forbyde fremstilling, indførsel, besiddelse salg, levering og/eller anvendelse af veterinærlægemidlet på hele eller en del af sit område, hvis det godtgøres:
English: Ensure that all the vaccine suspension is consumed within 1-2 hours.
Danish: Sørg for, at al vaccinesuspension er anvendt inden for 1-2 timer.
English: Date of last renewal: 21/05/2008.
Danish: Dato for seneste fornyelse af markedsføringstilladelse: 21/05/2008.
English: Feed should be available when vaccinating.
Danish: Der skal være adgang til foder, når der vaccineres.
English: Intranasal/ocular administration
Danish: Intranasal/okulær administration
English: Wash and disinfect hands and equipment after vaccinating to avoid spread of the virus.
Danish: Vask og desinficér hænder og udstyr efter vaccination for at undgå spredning af virus.
English: Vaccination programme The veterinarian should determine the optimum vaccination schedule according to the local situation.
Danish: Vaccinationsprogram Dyrlægen bør fastlægge det optimale vaccinationsprogram afhængig af den pågældende situation.
English: Care should be taken to avoid the introduction of the variant strain into an area where it is not present.
Danish: Der skal udøves forsigtighed, således at introduktion af stammevarianten i et område, hvor den ikke er til stede, undgås.
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Danish: a) at behandling af dyr med lægemidlet griber forstyrrende ind i gennemførelsen af et nationalt program til diagnosticering, bekæmpelse eller udryddelse af sygdomme hos dyr eller gør det vanskeligt at bekræfte, at levende dyr eller levnedsmidler eller andre produkter, der hidrører fra behandlede dyr, ikke er kontamineret,
English: Active substance:
Danish: Aktiv stof:
English: Where the number of chickens is between the standard dosages, the next higher dosage should be used.
Danish: Såfremt antallet af kyllinger ligger imellem standard-doseringerne, bør næste højere dosis anvendes.
English: Use cool, clean water to dissolve the vaccine.
Danish: Anvend koldt, rent vand til opløsning af vaccinen.
English: Chickens should be vaccinated against other prevalent IBV serotypes (e.g. Massachusetts) according to the local IB vaccination programme.
Danish: Kyllinger skal vaccineres mod andre prevalente IBV serotyper (f.eks. Massachusetts) i henhold til det lokale IB vaccinationsprogram.
English: Ocular/intranasal administration or coarse spray gives the best responses and these should be the methods of choice, especially when vaccinating young chickens.
Danish: Okulær/intranasal administration eller grov spray giver det bedste respons, og disse bør være de foretrukne metoder, især når unge kyllinger vaccineres.
English: ≥3.6 log10 EID50 IBV per dose
Danish: ≥ 3,6 log10 EID50 IBV pr. dosis
English: However, the chance of a hazard occurring has been estimated very low and is minimized by routinely vaccinating all chickens on the premise at the same time and cleaning and disinfection after each production round.
Danish: Risikoen er imidlertid blevet vurderet som meget lavt og minimeres ved rutinemæssig vaccination af alle kyllinger i flokken på samme tid samt rengøring og desinfektion efter vaccination.
English: Ensure that the nasal drop is inhaled before freeing the bird.
Danish: Kontroller, at den nasalt applicerede dråbe er inhaleret, før fuglen slippes fri.
English: Ten times the maximum dose was shown to be safe for the target species by all the recommended routes and methods of administration.
Danish: Det er vist, at 10 gange den maksimale dosis kan anvendes til den anførte dyreart uden risiko ved alle anbefalede indgivelsesveje og administrationsmetoder.
English: In case of the product presented in cups, do not use the product if the contents are brownish and stick to the container as this indicates that the integrity of the container has been breached.
Danish: Hvis produktet leveres i bægre, må det ikke anvendes hvis indholdet er brunligt og klæber til beholderen, da dette er tegn på, at beholderen har været brudt.
English: For heavy breeds, or in hot weather, the quantity of water may be increased up to 40 litres per 1,000 doses.
Danish: For tunge racer eller i varmt vejr kan vandmængden øges op til 40 liter pr. 1.000 doser.
English: The vaccine should preferably be dissolved in distilled water or alternatively in cool, clean water.
Danish: Vaccinen bør fortrinsvis opløses i destilleret vand eller som alternativ i koldt, rent vand.
English: The product should only be used after it has been established that IBV variant strain 4-91 is epidemiologically relevant in the area.
Danish: Produktet bør udelukkende anvendes, når det er fastslået, at IBV stammevariant 4-91 er epidemiologisk relevant i området.
English: The length of time of water deprivation is strongly dependent on the climatological circumstances.
Danish: Det tidsrum, hvor vandforsyningen er afbrudt, afhænger i høj grad af de klimatiske forhold.