FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substances in the medicine, lidocaine and prilocaine, are local anaesthetics that temporarily numb the contact area by reversibly blocking the transmission of signals in the nerves.
Danish: De aktive stoffer i lægemidlet, lidocain og prilocain, er lokalbedøvende midler, der midlertidigt bedøver det behandlede område ved reversibel blokering af overførslen af nervesignaler.
English: The most common side effects with Senstend (which may affect up to 1 in 10 people) are hypoaesthesia (reduced sensation) and a burning sensation in the genital area in both men and their female sexual partners, and erectile dysfunction (inability to maintain a normal erection) in men.
Danish: De hyppigste bivirkninger ved Senstend (som kan forekomme hos op til 1 ud af 10 personer) er hypoæstesi (nedsat følelse) og en brændende fornemmelse i og omkring kønsorganerne hos både mænd og deres kvindelige sexpartnere samt erektil dysfunktion hos mænd (manglende evne til at opnå og fastholde rejsning).
English: Side effects reported with Senstend are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Senstend vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: The recommended dose is three sprays onto the head (glans) of the penis before intercourse.
Danish: Den anbefalede dosis er tre sprayaktiveringer på penishovedet (glans) før samleje.
English: In both studies, patients given the medicine reported substantially greater improvements in reported control, sexual satisfaction and distress than patients given the placebo.
Danish: I begge studier oplevede de patienter, der var blevet behandlet med lægemidlet, en væsentligt større bedring af kontrol, seksuel tilfredsstillelse og frustration end de patienter, der havde fået placebo.
English: The main measures of effectiveness were the time taken to ejaculate after penetration and the amount of control over ejaculation, sexual satisfaction and distress reported by the patients.
Danish: De primære mål for virkningen var tiden til sædafgang efter penetration og graden af kontrol over sædafgang, seksuel tilfredsstillelse og frustration som rapporteret af patienterne.
English: How is Senstend used?
Danish: Hvordan anvendes Senstend?
English: Senstend must not be used in patients who are hypersensitive (allergic) to any of the ingredients of the medicine or to other local anaesthetics with a structure related to the active ingredients (amidetype local anaesthetics).
Danish: Senstend må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for et eller flere af indholdsstofferne i lægemidlet eller over for andre lokalbedøvende midler, hvis struktur er beslægtet med de aktive stoffer (lokalbedøvende midler af amidtypen).
English: average ejaculation time in patients using the medicine was 3.8 minutes compared with 1.1 minute in the placebo group.
Danish: I det andet studie var den gennemsnitlige tid til sædafgang hos Senstend-behandlede patienter 3,8 minutter sammenholdt med 1,1 minut i placebogruppen.
English: What benefits of Senstend have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Senstend?
English: For the full list of side effects reported with Senstend, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Senstend fremgår af indlægssedlen.
English: The effectiveness of Senstend has been shown in two main studies involving 256 and 300 heterosexual adult men with premature ejaculation, respectively; both studies compared the medicine with a placebo (dummy) spray over 12 weeks.
Danish: Virkningen af Senstend er påvist i to hovedstudier med hhv. 256 og 300 heteroseksuelle voksne mænd med for tidlig sædafgang.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Senstend 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 Senstend.
English: How does Senstend work?
Danish: Hvordan virker Senstend?
English: In the first study, the average time to ejaculation in patients treated with Senstend was 2.6 minutes, compared with 0.8 minutes in those using placebo; in the second study,
Danish: patienter 2,6 minutter sammenholdt med 0,8 minut hos dem, der brugte placebo.
English: This was switched to a full marketing authorisation on 14 July 2009.
Danish: Den blev ændret til en fuldgyldig markedsføringstilladelse den 14. juli 2009.
English: Further information on Isentress can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Yderligere information om Isentress findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Isentress has been studied in six main studies.
Danish: Isentress har været genstand for seks hovedstudier.
English: Therefore, the effectiveness observed in adults is also expected in children.
Danish: Den virkning, der blev iagttaget hos voksne, kan derfor også forventes hos børn.
English: The response was sustained for at least 48 weeks;
Danish: Virkningen fastholdtes i mindst 48 uger.
English: As for all medicines, data on the use of Isentress are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Isentress løbende overvåget.
English: Isentress received a conditional marketing authorisation valid throughout the European Union for Isentress on 20 December 2007.
Danish: Europa-Kommissionen udstedte en betinget markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Isentress den 20. december 2007.
English: Isentress was as effective as efavirenz.
Danish: Isentress var lige så effektivt som efavirenz.
English: Side effects in children were comparable to those in adults.
Danish: Bivirkningerne hos børn var sammenlignelige med dem hos voksne.
English: Equivalent doses of these different forms do not all produce the same levels of raltegravir in the body, so they must not be used interchangeably.
Danish: Tilsvarende doser af lægemidlets forskellige former danner ikke alle samme mængde af raltegravir i kroppen, så de må ikke bruges i flæng.
English: This study looked at viral loads after 24 and 48 weeks.
Danish: I dette studie blev der set nærmere på virusbelastningen efter 24 og 48 uger.
English: What measures are being taken to ensure the safe and effective use of Isentress?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Isentress?
English: There have also been uncommon reports of rhabdomyolysis (breakdown of muscle fibres).
Danish: Der har også været ualmindelige indberetninger om rhabdomyolyse (nedbrydning af muskelfibre).
English: Side effects reported with Isentress are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Isentress vurderes omhyggeligt, og der tages i givet fald nødvendige forholdsregler for at beskytte patienterne.
English: An overview of Isentress and why it is authorised in the EU
Danish: En oversigt over Isentress og hvorfor det er godkendt i EU
English: The European Medicines Agency therefore decided that Isentress's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Isentress opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: When the enzyme is blocked, the virus cannot reproduce normally, slowing down the spread of infection.
Danish: Når enzymet blokeres, kan virusset ikke formere sig normalt, hvilket forsinker spredningen af infektionen.
English: What is Isentress and what is it used for?
Danish: Hvad er Isentress, og hvad anvendes det til?
English: Why is Isentress authorised in the EU?
Danish: Hvorfor blev Isentress godkendt i EU?
English: • A sixth study included 26 children aged 4 weeks to 2 years who were given Isentress oral granules made into a suspension.
Danish: • Et sjette studie omfattede 26 børn i alderen fire uger til to år, som fik Isentress som oralt granulat blandet op til en suspension.
English: The medicine is available as tablets to be swallowed (400 and 600 mg), chewable tablets (25 and 100 mg) and sachets containing granules for an oral suspension (each sachet containing 100 mg).
Danish: Lægemidlet er tilgængeligt som synketabletter (400 og 600 mg), tyggetabletter (25 og 100 mg) og breve, der indeholder et granulat, der blandes til en oral suspension (hvert brev indeholder 100 mg).
English: Isentress does not cure HIV infection or AIDS, but it may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Isentress helbreder ikke hivinfektion eller aids, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
English: For more information about using Isentress see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Isentress, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: • Additional supportive studies established doses that provide similar effective levels of Isentress in newborn infants as in young children.
Danish: • I yderligere understøttende studier blev der fastsat doser, som giver ensartede niveauer af Isentress hos spædbørn og småbørn.
English: The active substance in Isentress, raltegravir, is an integrase inhibitor.
Danish: Det aktive stof i Isentress, raltegravir, er en integrasehæmmer.
English: Patients also received the medicine Truvada (emtricitabine with tenofovir disoproxil).
Danish: Patienterne fik også lægemidlet Truvada (emtricitabin med tenofovir disoproxil).
English: Other information about Isentress:
Danish: Andre oplysninger om Isentress
English: Isentress has been shown to be effective in helping control HIV when used with other HIV medicines.
Danish: Isentress har vist sig at være effektivt til at bidrage til kontroll af hiv, når det anvendes sammen med andre hiv-lægemidler.
English: • Isentress has also been studied in a fifth study involving 126 HIV-1 infected children between 2 and 18 years whose existing treatment for HIV infection was not working.
Danish: • Isentress var endvidere genstand for et femte studie, der omfattede 126 hiv-1-smittede børn mellem to år og 18 år, hos hvem den igangværende behandling for hivinfektion ikke havde nogen virkning.
English: The most common side effects with Isentress (seen in between 1 and 10 patients in 100) are headache, abdominal pain (stomach ache) and nausea (feeling sick).
Danish: De hyppigste bivirkninger ved Isentress (som optræder hos mellem 1 og 10 patienter ud af 100) er hovedpine, mavepine og kvalme.
English: All of the patients also took tenofovir and emtricitabine (other HIV medicines).
Danish: Samtlige af patienterne tog desuden tenofovir og emtricitabin (andre lægemidler mod hiv).
English: Isentress is an HIV medicine that is used in combination with other HIV medicines to treat patients who are infected with human immunodeficiency virus (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Isentress er et lægemiddel mod hiv, der anvendes i kombination med andre lægemidler mod hiv til behandling af patienter, som er smittet med humant immundefektvirus (hiv-1), et virus, der er årsag til erhvervet immundefektsyndrom (aids).
English: What are the risks associated with Isentress?
Danish: Hvilke risici er der forbundet med Isentress?
English: • A fourth study in 802 patients who had not taken HIV treatment before showed that giving Isentress as a single dose of 1,200 mg once daily was as effective as giving 400 mg twice daily.
Danish: • Af et fjerde studie hos 802 patienter, der ikke før havde gennemgået hivbehandling, fremgik det, at Isentress i doser a 1 200 mg én gang dagligt var lige så effektivt som Isentress i doser a 400 mg to gange dagligt.
English: The most common serious side effects are immune reconstitution syndrome (symptoms of infection caused by a recovering immune system) and rash.
Danish: De hyppigste alvorlige bivirkninger er immunreaktiveringssyndrom (infektionslignende symptomer, der skyldes, at immunsystemet genvinder sin funktion) og udslæt.
English: The granules are to make a mixture for babies and children to drink, the chewable tablets are for bigger children, and the 400- and 600-mg tablets are for different dose regimens in older children and adults, as recommended by the doctor.
Danish: Granulatet bruges til at lave en blanding, som spædbørn og mindre børn kan drikke, mens tyggetabletterne er beregnet til større børn, og 400 mg- og 600 mg-tabletterne er beregnet til større børn og voksne, i forskellige doser efter lægens anbefaling.
English: Isentress, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Når Isentress tages i kombination med andre lægemidler mod hiv, nedsættes mængden af hiv i blodet og holdes på et lavt niveau.
English: For the full list of side effects and restrictions with Isentress, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Isentress fremgår af indlægssedlen.
English: The studies compared Isentress with placebo (a dummy treatment), which were added to ‘optimised background therapy' (a combination of other HIV medicines chosen for each patient as it had the best chances of reducing the levels of HIV in the blood).
Danish: I undersøgelserne blev Isentress sammenlignet med placebo (en virkningsløs behandling) som tillægsbehandling til en "optimeret baggrundsbehandling" (en kombination af andre lægemidler mod hiv, der er skræddersyet til hver enkelt patient, da sandsynligheden for at reducere hivmængden i blodet derved er størst).
English: • Two studies involved a total of 699 ‘treatment-experienced' patients who were already receiving treatment for HIV infection that was not working.
Danish: • To studier omfattede i alt 699 "behandlingserfarne" patienter, hos hvem den igangværende behandling for hivinfektion ikke havde nogen virkning.
English: Isentress can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of HIV infection.
Danish: Isentress udleveres kun på recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af hivinfektion.
English: Isentress treatment led to a reduction in viral load and after 48 weeks 53% of the children had viral loads below 50 copies/ml.
Danish: Behandlingen med Isentress medførte en reduktion af virusbelastningen, og efter 48 uger havde 53 % af børnene en virusbelastning på under 50 kopier/ml.
English: The study showed that Isentress, given as tablets to be swallowed or chewable tablets, was safe in children and levels of the medicine obtained in the blood in children were similar to those obtained in adults.
Danish: Studiet viste, at Isentress givet som synketabletter eller tyggetabletter var sikkert til anvendelse hos børn, og at mængden af lægemidlet i børnenes blod svarede til den hos voksne.
English: After 48 weeks, 89% (472 of 531) of those on the once daily dose and 88% (235 of 266) of those taking Isentress twice daily had viral loads less than 40 copies/ml;
Danish: Efter 48 uger havde 89 % (472 ud af 531) af dem, der tog én daglig dosis, og 88 % (235 ud af 266) af dem, der tog Isentress to gange dagligt, en virusbelastning på under 40 kopier/ml.
English: Isentress contains the active substance raltegravir.
Danish: Det indeholder det aktive stof raltegravir.
English: After 48 weeks, 86% of the patients taking Isentress had viral loads below 50 copies/ml (241 out of 281), compared with 82% of those taking efavirenz (230 out of 282);
Danish: Efter 48 uger havde 86 % af de patienter, som tog Isentress, en virusbelastning på under 50 kopier/ml (241 ud af 281), sammenlignet med 82 % af dem, der tog efavirenz (230 ud af 282).
English: How is Isentress used?
Danish: Hvordan anvendes Isentress?
English: The main measure of effectiveness was the number of patients who had ‘undetectable' viral loads (below 50 copies per millilitre of blood) after 48 weeks.
Danish: Virkningen blev hovedsagelig målt på antallet af patienter, hos hvem der ikke var nogen påviselig virusbelastning (under 50 kopier/ml blod) efter 48 uger.
English: What benefits of Isentress have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Isentress?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Isentress 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 Isentress.
English: How does Isentress work?
Danish: Hvordan virker Isentress?
English: The main measure of effectiveness was the reduction in the levels of HIV in the blood (viral load) after 16 weeks; 77% of the patients who took Isentress had viral loads below 400 copies/ml after 16 weeks, compared with 42% of those who took placebo.
Danish: 77 % af de patienter, der tog Isentress, havde en virusbelastning på under 400 kopier/ml efter 16 uger sammenlignet med 42 % af dem, der tog placebo.
English: • A third study involved 566 patients who had not taken HIV treatment before and compared Isentress with efavirenz (another HIV medicine).
Danish: • Et tredje studie omfattede 566 patienter, som ikke tidligere havde gennemgået hivbehandling.
English: • Other conditions
Danish: • Andre betingelser
English: Tel: +353 (0)1 4515011 Fax: +353 (0)1 4621859
Danish: Tfl: Fax: +353 (0)1 4621859
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede) - Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13/09/2011
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 13/09/2011
English: The MAH must ensure that the system of pharmacovigilance, as described in Part 1 of the marketing authorisation application, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelse skal sikre, at lægemiddelovervågningssystemet, som beskrevet i del 1 af ansøgningen om markedsføringstilladelse, er i orden og funger inden og under markedsføring af lægemidlet.
English: Marketing authorisation holder and manufacturer responsible for batch release: Bimeda Animal Health Limited,
Danish: Indehaver af markedsføringstilladelse og fremstiller ansvarlig for batchfrigivelse: Bimeda Animal Health Limited,
English: The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No. 37/2010 indicates that no MRLs are required.
Danish: Hjælpestofferne nævnt i afsnit 6.1 iSPC'et er tilladte stoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, atMRL-værdier ikke er påkrævet.
English: Date of last renewal: 09/08/2016
Danish: Dato for seneste fornyelse af markedsføringstilladelse: 09/08/2016
English: Cattle and pigs: Can be used during pregnancy and lactation.
Danish: Kvæg og svin:Kan anvendes under drægtighed og laktation.
English: LOT {number}
Danish: {måneder/år}
English: Pigs: IM
Danish: Svin: IM
English: In horses, a transient swelling at the injection site can occur but resolves without intervention.
Danish: Hos heste kan der forekomme en forbigående hævelse på injektionsstedet, som forsvinder uden indgreb.
English: Excipient: Ethanol 99.9% 150 mg
Danish: Hjælpestof: Ethanol 99,9 % 150 mg
English: Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams) ATCvet code: QM01AC06
Danish: FARMAKOLOGISKE EGENSKABER Farmakoterapeutisk gruppe: Antiinflammatoriske og antireumatiske lægemidler, non-steroider (oxicam) ATCvet-kode: QM01AC06
English: Horses: IV
Danish: Heste: IV
English: MANUFACTURER'S BATCH NUMBER LOT {number}
Danish: FREMSTILLERENS BATCHNUMMER Parti{nummer}
English: In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should be treated symptomatically.
Danish: I meget sjældne tilfælde kan der forekomme anafylaktiske reaktioner, som kan være alvorlige (herunder dødelige).
English: Cattle: SC, IV
Danish: Kvæg: SC, IV
English: For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
Danish: Til anvendelse ved ikke-smitsomme lokomotoriske forstyrrelser med henblik på at reducere symptomer på halthed og inflammation.
English: Anhydrous citric acid Poloxamer 188
Danish: Vandfri citronsyre Poloxamer 188
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years Shelf life after first opening the immediate packaging: 28 days 6.4.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 3 år Opbevaringstid efter første åbning af den indre emballage: 28 dage 6.4.
English: All major metabolites have been shown to be pharmacologically inactive.
Danish: Alle hovedmetabolitter har vist sig at være farmakologisk inaktive.Metabolismen hos heste er ikke undersøgt.
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Danish: Natriumhydroxid (pH-justering) Saltsyre (pH-justering) Vand til injektioner
English: In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of the diagnosis should be made as this could indicate the need for surgical intervention.
Danish: I tilfælde af utilstrækkelig smertelindring ved behandling af kolik hos heste bør diagnosen revurderes omhyggeligt, da der kan være behov for kirurgisk indgreb.
English: Clear yellow solution.
Danish: Klar, gul opløsning
English: Do not broach more than 50 times.
Danish: Proppen må højst perforeres 50 gange.
English: The active substance in Recocam 20 mg/ml solution for injection for cattle, pigs and horses is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Danish: Den aktive substansi Recocam 20 mg/ml injektionsvæske, opløsning, til kvæg, svin og heste, er etgodkend(t)substanser som beskrevet i tabel 1 i bilaget til Kommissionens forordning (EU) Nr.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Danish: DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN Yderligere informationom dette veterinærlægemiddel er tilgængelige på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu).
English: A slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
Danish: Der forekom let og forbigående hævelse på injektionsstedet efter subkutan administration hos mindre end 10 % af kvæget i de kliniske undersøgelser.