FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/113/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/99/113/001
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: - Tal med lægen eller sundhedspersonalet, hvis en bivirkning bliver værre, eller hvis du får bivirkninger, som ikke er nævnt her.
English: Respiratory, thoracic and mediastinal disorders
Danish: Carcinogenese, mutagenese, nedsat frugtbarhed
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/113/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/99/113/003
English: • Disease in the oesophagus (the tube that carries food into your stomach)
Danish: • Mavesmerter, der skyldes væskeansamling i maven (ascites), tarmbetændelse,
English: • Feeling faint
Danish: • Træthedsfølelse
English: It is available as an oral solution (100 mg/ml).
Danish: Det fås som en opløsning (100 mg/ml).
English: The full EPAR for Levetiracetam Actavis Group 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 Group 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 Group on 5 December 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Levetiracetam Actavis Group den 5 december 2011.
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 Levetiracetam Actavis Group.
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 anvendelsesbetingelserne for Levetiracetam Actavis Group.
English: This helps levetiracetam to stabilise electrical activity in the brain and prevent seizures.
Danish: På denne måde stabiliserer levetiracetam den elektriske aktivitet i hjernen og forhindrer anfald.
English: This means that Levetiracetam Actavis Group is similar to a ‘reference medicine' already authorised in the European Union (EU) called Keppra.
Danish: Det betyder, at Levetiracetam Actavis Group er identisk med et ‘referencelægemiddel', der allerede er godkendt i Den Europæiske Union (EU), og som hedder Keppra.
English: This is a summary of the European public assessment report (EPAR) for Levetiracetam Actavis Group.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Levetiracetam Actavis Group.
English: The CHMP concluded that, in accordance with EU requirements, Levetiracetam Actavis Group has been shown to have comparable quality and to be bioequivalent to Keppra.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Levetiracetam Actavis Group er af sammenlignelig kvalitet og er bioækvivalent med Keppra.
English: For more information about treatment with Levetiracetam Actavis Group, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Levetiracetam Actavis Group, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Levetiracetam Actavis Group can also be used as an add-on to other anti-epileptic medicines to treat:
Danish: Levetiracetam Actavis Group kan også anvendes som tillægsbehandling til andre antiepileptika til behandling af:
English: The most common side effects with Levetiracetam Actavis Group (seen in more than 1 patient in 10) are somnolence (sleepiness), and asthenia (weakness) or fatigue (tiredness).
Danish: De hyppigste bivirkninger ved Levetiracetam Actavis Group (som optræder hos flere end 1 ud af 10 patienter) er somnolens (søvnighed), kraftesløshed og træthed.
English: Levetiracetam Actavis Group must not be used in people who are hypersensitive (allergic) to levetiracetam, to other pyrrolidone derivatives (medicines with a similar structure to levetiracetam), or to any of the other ingredients.
Danish: Levetiracetam Actavis Group må ikke anvendes til patienter, der er overfølsomme (allergiske) over for levetiracetam, andre pyrrolidonderivater (lægemidler med en struktur, der ligner levetiracetam) eller andre af indholdsstofferne.
English: In babies aged between one and six months, the starting dose is 7 mg/kg twice a day, using the oral solution.
Danish: Til spædbørn i alderen mellem en og seks måneder er startdosis 7 mg/kg to gange dagligt i form af den orale opløsning.
English: Because Levetiracetam Actavis Group is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Keppra.
Danish: Da Levetiracetam Actavis Group er et generisk lægemiddel, har patientundersøgelserne været begrænset til tests for at påvise, at det er bioækvivalent med referencelægemidlet, Keppra.
English: Levetiracetam Actavis Group can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation.
Danish: Levetiracetam Actavis Group kan uden supplerende behandling anvendes til patienter på 16 år og derover med nydiagnosticeret epilepsi til behandling af partielle anfald med eller uden sekundær generalisering.
English: Other information about Levetiracetam Actavis Group
Danish: Andre oplysninger om Levetiracetam Actavis Group
English: When Levetiracetam Actavis Group is added to another anti-epileptic treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Danish: Når Levetiracetam Actavis Group anvendes som tillægsbehandling til en anden behandling med antiepileptika, er startdosis til patienter over 12 år, som vejer over 50 kg, 500 mg to gange dagligt.
English: Levetiracetam Actavis Group is a medicine that contains the active substance levetiracetam.
Danish: Levetiracetam Actavis Group er et lægemiddel, der indeholder det aktive stof levetiracetam.
English: Levetiracetam Actavis Group is a ‘generic medicine'.
Danish: Levetiracetam Actavis Group er et ‘generisk lægemiddel'.
English: Because Levetiracetam Actavis Group is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Levetiracetam Actavis Group er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: The active substance in Levetiracetam Actavis Group, levetiracetam, is an anti-epileptic medicine.
Danish: Det aktive stof i Levetiracetam Actavis Group, levetiracetam, er et antiepileptikum.
English: For the full list of all side effects reported with Levetiracetam Actavis Group, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Levetiracetam Actavis Group fremgår af indlægssedlen.
English: The Committee recommended that Levetiracetam Actavis Group be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Levetiracetam Actavis Group.
English: When Levetiracetam Actavis Group is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Danish: Når Levetiracetam Actavis anvendes alene, er startdosis 250 mg to gange dagligt, som efter to uger øges til 500 mg to gange dagligt.
English: What benefit has Levetiracetam Actavis Group shown during the studies?
Danish: Hvilken fordel viste Levetiracetam Actavis Group sig at have i undersøgelserne?
English: • myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from
Danish: • myoklone anfald (kortvarige, rykvise trækninger i en muskel eller muskelgruppe) hos patienter fra 12-års alderen med juvenil myoklon epilepsi
English: What is the risk associated with Levetiracetam Actavis Group?
Danish: Hvilken risiko er der forbundet med Levetiracetam Actavis Group?
English: Why has Levetiracetam Actavis Group been approved?
Danish: Hvorfor blev Levetiracetam Actavis Group godkendt?
English: How has Levetiracetam Actavis Group been studied?
Danish: Hvordan blev Levetiracetam Actavis Group undersøgt?
English: What is Levetiracetam Actavis Group?
Danish: Hvad er Levetiracetam Actavis Group?
English: What is Levetiracetam Actavis Group used for?
Danish: Hvad anvendes Levetiracetam Actavis Group til?
English: How is Levetiracetam Actavis Group used?
Danish: Hvordan anvendes Levetiracetam Actavis Group?
English: How does Levetiracetam Actavis Group work?
Danish: Hvordan virker Levetiracetam Actavis Group?
English: The third study involved 59 children aged 2 to 12 years.
Danish: Det tredje studie omfattede 59 børn i alderen 2-12 år.
English: Vihuma received a marketing authorisation valid throughout the EU on 13 February 2017.
Danish: Vihuma fik en markedsføringstilladelse med gyldighed i hele EU den 13. februar 2017.
English: Further information on Vihuma can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Vihuma.
Danish: Yderligere information om Vihuma findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Vihuma.
English: This medicine is the same as Nuwiq, which is already authorised in the EU.
Danish: Lægemidlet er identisk med Nuwiq, som allerede er godkendt i EU.
English: Other information about Vihuma
Danish: Andre oplysninger om Vihuma
English: The company that makes Nuwiq has agreed that its scientific data can be used for Vihuma (‘informed consent').
Danish: Virksomheden, som fremstiller Nuwiq, har indvilget i, at dens videnskabelige oplysninger må anvendes for Vihuma (informeret samtykke).
English: Vihuma can be used for short-term or long-term treatment.
Danish: Vihuma kan anvendes til kortvarig eller langvarig behandling.
English: What measures are being taken to ensure the safe and effective use of Vihuma?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Vihuma?
English: As for all medicines, data on the use of Vihuma are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Vihuma løbende overvåget.
English: What are the risks associated with Vihuma?
Danish: Hvilke risici er der forbundet med Vihuma?
English: An overview of Vihuma and why it is authorised in the EU
Danish: En oversigt over Vihuma, og hvorfor det er godkendt i EU
English: A total of 986 bleeding episodes were recorded, most of which resolved with one injection of Vihuma.
Danish: Der blev i alt registreret 986 blødningsepisoder, hvoraf størstedelen blev afhjulpet med én indsprøjtning af Vihuma.
English: For more information about using Vihuma, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Vihuma, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: What is Vihuma and what is it used for?
Danish: Hvad er Vihuma, og hvad anvendes det til?
English: Hypersensitivity (allergic) reactions have been reported with factor VIII medicines and they may be severe in some cases.
Danish: Der er indberettet allergiske reaktioner over for faktor VIII-lægemidler, som kan være alvorlige i visse tilfælde.
English: Why is Vihuma authorised in the EU?
Danish: Hvorfor blev Vihuma godkendt i EU?
English: Patients or their carers may be able to inject Vihuma themselves at home once they have been trained.
Danish: Patienten eller dennes omsorgsperson kan selv injicere Vihuma derhjemme efter at have fået passende oplæring.
English: The European Medicines Agency decided that Vihuma's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Vihuma opvejer risiciene, og det kan godkendes til anvendelse i EU.
English: Side effects reported with Vihuma are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Vihuma vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: The dose and duration of treatment depend on whether Vihuma is used to treat or prevent bleeding, or during surgery, as well as on the patient's factor VIII levels, the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition and weight.
Danish: Dosis og varighed af behandlingen afhænger af, om Vihuma skal anvendes til behandling eller til forebyggelse af blødning eller ved operation, og af patientens faktor VIII-niveauer, sygdommens sværhedsgrad, blødningens omfang og sted samt patientens tilstand og kropsvægt.
English: Treatment with Vihuma was rated ‘excellent' or ‘good' for 94% of bleeding episodes.
Danish: Behandlingen med Vihuma blev bedømt som "udmærket" eller "god" ved 94 % af blødningsepisoderne.
English: The active substance in Vihuma, simoctocog alfa (human coagulation factor VIII), is a substance that helps the blood to clot.
Danish: Det aktive stof i Vihuma, simoctocog alfa (human koagulationsfaktor VIII), er et stof, der hjælper blodet med at størkne.
English: Vihuma corrects the factor VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.
Danish: Vihuma anvendes til at korrigere manglen på faktor VIII ved at erstatte den manglende faktor VIII, hvorved der opnås midlertidig kontrol med blødningsforstyrrelsen.
English: Some patients treated with factor VIII medicines may develop inhibitors (antibodies) against factor VIII, which may stop the medicine from working and controlling bleeding.
Danish: Nogle patienter, der behandles med faktor VIII-lægemidler, kan udvikle inhibitorer (antistoffer) mod faktor VIII, så lægemidlet holder op med at virke og kontrollere blødninger.
English: Vihuma can only be obtained with a prescription, and treatment should be supervised by a doctor experienced in the treatment of haemophilia.
Danish: Vihuma udleveres kun efter recept, og ordination og behandling bør overvåges af en læge med erfaring i behandling af hæmofili.
English: The Agency concluded that Vihuma was effective at treating and preventing bleeding in patients with haemophilia A and it has an acceptable safety profile.
Danish: Agenturet besluttede, at Vihuma er effektivt til at behandle og forebygge blødning hos patienter med hæmofili A og har en acceptabel sikkerhedsprofil.
English: Vihuma was effective at preventing and treating bleeding episodes in three main studies involving 113 patients with haemophilia A.
Danish: Vihuma var effektivt til at behandle og forebygge blødningsepisoder i tre hovedstudier, hvori der deltog 113 patienter med hæmofili A.
English: For the full list of side effects and restrictions of Vihuma, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Vihuma fremgår af indlægssedlen.
English: Vihuma is a medicine used for the treatment and prevention of bleeding in patients of all ages with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Danish: Vihuma er et lægemiddel, der anvendes til behandling og forebyggelse af blødning hos patienter i alle aldre med hæmofili A (en arvelig blødersygdom, der skyldes mangel på faktor VIII).
English: When Vihuma was used for treatment, bleeding episodes resolved in 81% of cases following 1 or 2 injections.
Danish: Når Vihuma blev anvendt til behandling af blødning, fortog blødningerne sig i 81 % af tilfældene efter 1 eller 2 indsprøjtninger med Vihuma.
English: How is Vihuma used?
Danish: Hvordan anvendes Vihuma?
English: Patients with haemophilia A lack factor VIII, and this causes blood clotting problems leading to events such as bleeding in the joints, muscles or internal organs.
Danish: Patienter med hæmofili A mangler faktor VIII, og dette medfører problemer med blodets størkning såsom blødning i led, muskler eller indre organer.
English: When used for treating bleeding episodes, Vihuma was mainly rated ‘excellent' or ‘good' at treating major bleeding episodes and most bleeding episodes resolved following one or more injections of Vihuma.
Danish: Når Vihuma blev anvendt til behandling af blødningsepisoder, blev det hovedsagelig bedømt som "udmærket" eller "godt" til behandling af større blødningsepisoder, og de fleste blødningsepisoder aftog efter en eller flere indsprøjtninger med Vihuma.
English: When Vihuma was used to prevent bleeding, an average of 0.34 bleeding episode per month was recorded for each child.
Danish: Når Vihuma blev anvendt til forebyggelse af blødning, var der gennemsnitligt 0,34 blødningsepisode pr. måned for hvert barn.
English: In the 2 surgeries during the study, Vihuma was rated excellent in preventing bleeding episodes.
Danish: Ved de to operationer, der blev udført i løbet af studiet, blev Vihuma bedømt som udmærket til at forebygge blødningsepisoder.
English: What benefits of Vihuma have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Vihuma?
English: The first study involved 22 patients aged 12 years and above, who were given Vihuma for the treatment of bleeding episodes or to prevent bleeding during surgery.
Danish: I det første studie deltog 22 patienter over 12 år, som fik Vihuma til behandling af blødningsepisoder eller til forebyggelse af blødning ved operation.
English: In the 5 surgeries during the study, Vihuma was rated excellent in preventing bleeding episodes for 4 surgeries and as moderate to prevent bleeding during one surgical intervention.
Danish: Ved de 5 operationer, der blev udført i løbet af studiet, blev Vihuma bedømt som udmærket til at forebygge blødningsepisoder ved fire operationer og som nogenlunde til at forebygge blødning ved én operation.
English: When used to prevent bleeding, an average of 0.19 bleeding episode per month was recorded for each patient.
Danish: Når Vihuma blev anvendt til forebyggelse af blødning, havde hver patient gennemsnitligt 0,19 blødningsepisode pr. måned.
English: Vihuma is available as a powder and solvent to mix together to make a solution that is injected into a vein.
Danish: Vihuma leveres som et pulver med opløsningsvæske (solvens), der blandes sammen til en opløsning, som gives ved injektion i en vene.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vihuma 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 Vihuma.
English: The second study involved 32 patients aged 12 years and above who were given Vihuma to prevent and treat bleeding events as well as to prevent bleeding during surgery.
Danish: Det andet studie havde deltagelse af 32 patienter over 12 år, som fik Vihuma til forebyggelse og behandling af blødningsepisoder og til forebyggelse af blødning ved operation.
English: How does Vihuma work?
Danish: Hvordan virker Vihuma?
English: 0.1 mg Colourless suspension.
Danish: 0,1 mg Farveløs suspension.
English: ATCvet code QI07AB01.
Danish: ATCvet-kode:QI07AB01
English: Do not mix with any other veterinary medicinal products except those mentioned in section 4.8.
Danish: Må ikke blandes med andre lægemidler til dyr end dem, der er nævnt i afsnit 4.8.
English: (*) In case of high level of maternally derived antibodies, first vaccination is recommended at 9 weeks of age.
Danish: (*) I tilfælde af højt niveau af maternelle antistoffer, anbefales første vaccination ved 9 ugers alderen.
English: VIRBAC Ltd, Woolpit Business Park, Windmill Avenue, Woolpit,
Danish: VIRBAC Ltd, Woolpit Business Park, Windmill Avenue,
English: Special precautions for each target species: Vaccinate healthy animals only.
Danish: Særlige advarsler for hver dyreart: Vacciner kun raske dyr.
English: 10 ml (10 doses)
Danish: 10 ml (10 doser)
English: Pharmacotherapeutic group: Immunologicals for Canidae, inactivated bacterial vaccine.
Danish: Farmakoterapeutisk gruppe: Immunologisk inaktiverede bakterielle vacciner til canidae.
English: A mild and transient increase in body temperature (≤ 1°C) has been observed very commonly in clinical studies for a few days after vaccination, with some pups showing less activity and/or a reduced appetite.
Danish: Let forbigående øget kropstemperatur (≤ 1°C) er observeret som meget almindeligt i kliniske studier i få dage efter vaccination, hvorfor nogle hvalpe kan vise nedsat aktivitet og ædelyst.
English: Shelf life after reconstitution of Canigen vaccines according to directions: 45 mins.
Danish: Opbevaringstid efter rekonstitution af Canigen vacciner: 45 min.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Canigen L4
Danish: VETERINÆRLÆGEMIDLETS NAVN Canigen L4
English: Basic vaccination: The first vaccination can be administered from 6 to 9(*) weeks of age and the second vaccination from 10 to 13 weeks of age.
Danish: Basisvaccination: Den første vaccination kan gives fra 6-9(*) ugers alderen og den anden fra 10-13 ugers alderen.
English: When mixed with these Canigen vaccines, the demonstrated safety and efficacy claims for Canigen L4 are no different from those described for Canigen L4 alone.
Danish: Når Canigen L4 blandes med disse Canigen vacciner er oplysningerne om sikkerhed og effekt ikke forskellig fra dem beskrevet ved at anvende Canigen L4 alene.
English: 10x 1 ml (1 dose) 50x 1 ml (1 dose) 1x 10 ml (10 doses)
Danish: PAKNINGSSTØRRELSE 10x 1 ml (1 dosis) 50x 1 ml (1 dosis) 1x 10 ml (10 doser)
English: Potassium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Danish: Natriumchlorid Kaliumchlorid Dinatriumphosphatdihydrat Kaliumdihydrogenphosphat Vand til injektionsvæsker
English: The mixed vaccines should be at room temperature (15°C - 25°C) before they are administered by subcutaneous injection.
Danish: De opblandede vacciner skal opnå rumtemperastur (15°C - 25°C) inden de administreres ved subkutan injektion.
English: The product information of the relevant Canigen vaccines should be consulted before administration of the mixed product.
Danish: Læs produktresumeet for de relevante Canigen vacciner inden anvendelse af det blandede produkt.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/15/183/001-003
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/15/183/001-003
English: Shelf life after first opening the immediate container: 10 hours.
Danish: Opbevaringstid efter første åbning af den indre beholder: 10 timer.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten Opbevaringstid efter første åbning af beholderen: 10 timer.
English: If you notice any side effects,, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Danish: Dette gælder også bivirkninger, der ikke allerede er anført i denne indlægsseddel eller hvis du mener, at dette lægemiddel ikke har virket efter anbefalingerne.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 1 ml (1 dose)
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1 ml (1 dosis)
English: When mixed with Canigen vaccines containing canine parainfluenza virus strain Cornell at annual revaccination, it has been established that there is no interference with the anamnestic response induced by the injectable canine parainfluenza virus component.
Danish: Når Canigen L4 blandes med Canigen vacciner, som indeholder hundeparainfluenzavirus stamme Cornell ved årlig revaccination, er det påvist, at der ingen interferens er med det anamnestiske respons induceret ved injektion med hundeparainfluenzavirus komponenten.
English: 1 ml and 10 ml vial
Danish: 1 ml og 10 ml hætteglas