FrancophonIA/ELRC3.0 huggingface dataset:
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 Pantoloc Control.
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 Pantoloc Control.
English: For more information about treatment with Pantoloc Control, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Pantoloc Control, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The most common side effects with Pantoloc Control (seen in around 1 patient in 100) are diarrhoea and headache.
Danish: De hyppigste bivirkninger ved Pantoloc Control (som optræder hos omkring 1 ud af 100 patienter) er diarré og hovedpine.
English: Pantoloc Control must not be used in people who are hypersensitive (allergic) to pantoprazole, soya or any of the other ingredients.
Danish: Pantoloc Control må ikke anvendes af patienter, der er overfølsomme (allergiske) over for pantoprazol, soja eller andre af indholdsstofferne.
English: Pantoloc Control is used for the short-term treatment of the symptoms of acid reflux in adults.
Danish: Pantoloc Control anvendes til korttidsbehandling af symptomer på syrerefluks hos voksne.
English: Pantoloc Control is a medicine that contains the active substance pantoprazole.
Danish: Pantoloc Control er et lægemiddel, der indeholder det aktive stof pantoprazol.
English: The CHMP therefore decided that Pantoloc Control's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede derfor, at fordelene ved Pantoloc Control er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Pantoloc Control.
English: The active substance in Pantoloc Control, pantoprazole, is a proton pump inhibitor.
Danish: Det aktive stof i Pantoloc Control, pantoprazol, er en protonpumpehæmmer.
English: Pantoloc Control pantoprazole
Danish: Pantoloc Control pantoprazol
English: Pantoloc Control is similar to a ‘reference medicine' already authorised in the European Union (EU) called Pantoloc.
Danish: Pantoloc Control svarer til et referencelægemiddel ved navn Pantoloc, som allerede er godkendt i Den Europæiske Union (EU).
English: The reference medicine, Pantoloc, is only available with a prescription.
Danish: Referencelægemidlet Pantoloc udleveres kun efter recept.
English: It was also of the opinion that, based on the experience of the use of pantoprazole, the availability of Pantoloc Control without medical supervision is appropriate.
Danish: CHMP var også af den opfattelse, at adgangen til Pantoloc Control uden lægelig overvågning, baseret på erfaringerne med anvendelsen af pantoprazol, er passende.
English: Other information about Pantoloc Control
Danish: Andre oplysninger om Pantoloc Control:
English: What is the risk associated with Pantoloc Control?
Danish: Hvilken risiko er der forbundet med Pantoloc Control?
English: For the full list of all side effects reported with Pantoloc Control, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved pantoprazol fremgår af indlægssedlen.
English: Why has Pantoloc Control been approved?
Danish: Hvorfor blev Pantoloc Control godkendt?
English: How has Pantoloc Control been studied?
Danish: Hvordan blev Pantoloc Control undersøgt?
English: What is Pantoloc Control?
Danish: Hvad er Pantoloc Control?
English: What is Pantoloc Control used for?
Danish: Hvad anvendes Pantoloc Control til?
English: What benefit has Pantoloc Control shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Pantoloc Control?
English: How is Pantoloc Control used?
Danish: Hvordan anvendes Pantoloc Control?
English: How does Pantoloc Control work?
Danish: Hvordan virker Pantoloc Control?
English: 25 September 2013
Danish: Den 25. september 2013
English: The reference Member State was France and 12 concerned Member States were involved: Austria, Belgium, Denmark, Germany, Greece, Ireland, Italy, Luxembourg, Portugal, Slovenia, Spain and United Kingdom.
Danish: Referencemedlemsstaten var Frankrig, og der var 12 berørte medlemsstater: Østrig, Belgien, Danmark, Tyskland, Grækenland, Irland, Italien, Luxembourg, Portugal, Slovenien, Spanien og Det Forenede Kongerige.
English: The final opinion was converted into a Decision by the European Commission on 25 September 2013.
Danish: Den endelige udtalelse blev den 25. september 2013 omarbejdet til en beslutning af EuropaKommissionen.
English: The type II variation procedure (FR/V/0201/002/II/006) started on 16 May 2012.
Danish: Type II-ændringsproceduren (FR/V/0201/002/II/006) blev indledt den 16. maj 2012.
English: Day 60 of the CMD(v) procedure was on 14 March 2013, and since there was no agreement the procedure was referred to the CVMP.
Danish: Dag 60 af proceduren i CMD(v) var den 14. marts 2013, og da der ikke var enighed, blev proceduren indbragt for CVMP.
English: The product is administered topically on the back of the animal and is indicated for the treatment of mixed nematode and fluke infections in cattle.
Danish: Produktet administreres topikalt på dyrets ryg og er indiceret til behandling af blandede infektioner med nematoder og ikter hos kvæg.
English: International non-proprietary names (INN): moxidectin and triclabendazole
Danish: Internationale fællesnavne (INN): moxidectin og triclabendazol
English: Written explanations were provided by the marketing authorisation holder on 20 May 2013.
Danish: Indehaveren af markedsføringstilladelsen afgav skriftlige redegørelser den 20. maj 2013.
English: On Day 90, major issues raised by the CMS, Belgium, remained unsolved.
Danish: På dag 90 var de alvorlige problemer, der var rejst af den berørte medlemsstat Belgien, fortsat uafklarede.
English: The referral procedure started on 10 April 2013.
Danish: Henvisningsproceduren blev indledt den 10. april 2013.
English: On 3 April 2013, France referred the matter to the CVMP under Article 13(2) of Commission Regulation (EC) No 1234/2008.
Danish: Den 3. april 2013 indbragte Frankrig sagen for CVMP i henhold til artikel 13, stk. 2, i Kommissionens forordning (EF) nr. 1234/2008.
English: During the variation procedure a potential serious risk to animal health was identified by Belgium and in particular that the efficacy against the lice species had been insufficiently substantiated.
Danish: Under ændringsproceduren konstaterede Belgien en potentiel alvorlig risiko for dyrs sundhed, herunder at virkningen mod de pågældende lusearter ikke var tilstrækkeligt dokumenteret.
English: The Committee appointed Dr B. Urbain as rapporteur and Dr M. Holzhauser-Alberti as co-rapporteur.
Danish: Som rapportør og medrapportør udpegede udvalget henholdsvis dr. B. Urbain og dr. M. Holzhauser-Alberti.
English: The CVMP concluded that a satisfactory efficacy towards Linognatus vituli, Bovicola bovis and Solenopotes capillatus can be expected in the field.
Danish: CVMP konkluderede, at der kan forventes tilfredsstillende virkning i felten mod Linognatus vituli, Bovicola bovis og Solenopotes capillatus.
English: The CVMP was requested to give its opinion on whether or not the data for the type II variation application support the new indication against lice infestations.
Danish: CVMP blev anmodet om at fremsætte en udtalelse om, hvorvidt dataene i type II-ændringsansøgningen underbyggede den nye indikation mod angreb af lus.
English: The CMD(v) 60-day referral procedure was initiated on 14 January 2013.
Danish: Den 60dages indbringelsesprocedure i CMD(v) blev indledt den 14. januar 2013.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments of the relevant sections of the Summary of Product Characteristics, labelling and package leaflet in Annex III.
Danish: Listen over de berørte produktnavne fremgår af bilag I. De videnskabelige konklusioner fremgår af bilag II.
English: Cydectin TriclaMox (5 mg/ml and 200 mg/ml) pour-on solution for cattle is a veterinary medicinal product containing 5 mg moxidectin per ml and 200 mg triclabendazole per ml.
Danish: Cydectin TriclaMox pour-on, opløsning (5 mg/ml og mg/ml), til kvæg er et veterinærlægemiddel, der indeholder 5 mg moxidectin pr. ml og 200 mg triclabendazol pr. ml.
English: The marketing authorisation holder, Pfizer Animal Health, submitted an application for a type II variation, according to Article 16 of Commission Regulation (EC) 1234/2008, to add a new indication against lice species (Linognatus vituli, Bovicola bovis and Solenopotes capillatus) for Cydectin TriclaMox 5 mg/ml and 200 mg/ml pour-on solution for cattle.
Danish: Indehaveren af markedsføringstilladelsen, Pfizer Animal Health, indgav en ansøgning om en type IIændring i overensstemmelse med artikel 16 i Kommissionens forordning (EF) nr. 1234/2008 med henblik på tilføjelse af en ny indikation mod lusearterne Linognatus vituli, Bovicola bovis og Solenopotes capillatus for Cydectin TriclaMox, pour-on, opløsning, 5 mg/ml og 200 mg/ml, til kvæg.
English: The procedure was thus referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures-Veterinary (CMD(v)) under Article 13(1) of Commission Regulation (EC) No 1234/2008 on 11 December 2012 by the RMS (France).
Danish: Sagen blev den 11. december 2012 af referencemedlemsstaten (Frankrig) indbragt for koordinationsgruppen vedrørende gensidig anerkendelse og decentrale godkendelsesprocedurer, (CMD(v)) i henhold til artikel 13, stk. 1, i Kommissionens forordning (EF) nr. 1234/2008.
English: Based on the evaluation of the available data, the CVMP adopted, on 16 July 2013, an opinion recommending the granting of the variation to the marketing authorisations for Cydectin TriclaMox (5 mg/ml and 200 mg/ml) pour-on solution for cattle.
Danish: På grundlag af vurderingen af de foreliggende data vedtog CVMP den 16. juli 2013 en udtalelse, som anbefalede ændring af markedsføringstilladelserne for Cydectin TriclaMox, pour-on, opløsning, 5 mg/ml og 200 mg/ml, til kvæg.
English: Opinion following an Article 131 referral for Cydectin TriclaMox (5 mg/ml and 200 mg/ml) pour-on solution for cattle
Danish: Udtalelse efter en indbringelse i henhold til artikel 131 for Cydectin TriclaMox, pour-on, opløsning (5 mg/ml og 200 mg/l), til kvæg
English: Opinion following an Article 130F referral for Cydectin TriclaMox (5 mg/ml and 200 mg/ml) pour-on solution for cattle
Danish: Udtalelse efter en indbringelse i henhold til artikel 130F for Cydectin TriclaMox, pouron, opløsning (5 mg/ml og 200 mg/l), til kvæg EMA/549503/2013
English: The differences were not statistically significant.
Danish: Forskellene var ikke statistisk signifikante.
English: You have diabetes because your body:
Danish: Du har diabetes, fordi din krop:
English: This can be short or long-lasting.
Danish: Dette kan være kort- eller langvarigt.
English: Choose a time of the day that works best for you.
Danish: Vælg det tidspunkt på dagen, som passer dig bedst.
English: The duration of observation was minimum 3.5 years and up to a maximum of 5 years.
Danish: Observationsvarigheden var mindst 3,5 år op til maksimalt 5 år.
English: One study was further extended to 52 weeks.
Danish: Et studie blev yderligere udvidet til 52 uger.
English: Do not cover it with your fingers.
Danish: Du må ikke dække for den med fingrene.
English: This also applies when administration at the same time of the day is not possible.
Danish: Dette gælder også, hvis administration på samme tidspunkt af dagen ikke er mulig.
English: Then carry on with your medicine as usual.
Danish: Derefter kan du fortsætte med din medicin som sædvanlig.
English: How much solution is left?
Danish: Hvor meget opløsning er der tilbage?
English: The recommended starting dose should not be exceeded.
Danish: Den anbefalede startdosis bør ikke overskrides.
English: Date of first authorisation: 18 September 2014 Date of latest renewal: 08 July 2019
Danish: Dato for første markedsføringstilladelse: 18. september 2014 Dato for seneste fornyelse: 08. juli 2019
English: • how much Xultophy you will need each day
Danish: • hvor meget Xultophy du har behov for hver dag
English: The relevance for humans is likely to be low but cannot be completely excluded.
Danish: Relevansen af dette for mennesker er med stor sandsynlighed lav, men kan ikke fuldstændig udelukkes.
English: Local tolerance was assessed in rabbits and pigs.
Danish: Lokal tolerance blev vurderet hos kaniner og grise.
English: • If the pen is damaged or has not been stored correctly (see section 5).
Danish: • Hvis pennen er beskadiget eller ikke har været opbevaret korrekt (se punkt 5).
English: Turn until it is on tight.
Danish: Drej, indtil den sidder fast.
English: • is not able to use the insulin properly.
Danish: • ikke er i stand til at udnytte insulinet ordentligt.
English: • drink alcohol
Danish: • drikker alkohol
English: Component of a multipack, can't be sold separately
Danish: En del af en multipakning, kan ikke sælges separat.
English: • get an infection or a fever
Danish: • får en infektion eller feber
English: • eat too little or miss a meal
Danish: • spiser for lidt eller springer et måltid over
English: No data is available beyond 52 weeks of treatment.
Danish: Der er ingen tilgængelige data ud over 52 ugers behandling.
English: Look through the pen window.
Danish: Kig igennem penvinduet.
English: • Test your blood or urine for ketones.
Danish: • Kontrollér blodet eller urinen for ketoner.
English: Tell everyone you spend time with that you have diabetes.
Danish: Fortæl alle, du er sammen med, at du har diabetes.
English: • have eye problems.
Danish: • har øjenproblemer.
English: These reactions were usually mild and transitory and they normally disappear during continued treatment.
Danish: Sædvanligvis var disse reaktioner milde og forbigående, og de forsvinder normalt af sig selv under fortsat behandling.
English: • Do not store your pen at temperatures above 30°C.
Danish: • Opbevar ikke din pen ved temperaturer over 30°C.
English: Your doctor will tell you:
Danish: Lægen vil fortælle dig:
English: Further important information • Always keep an extra pen and new needles, in case of loss or damage.
Danish: Yderligere vigtig information • Hav altid en ekstra pen og nye nåle parat, i tilfælde af tab eller beskadigelse.
English: What others need to do if you pass out:
Danish: Hvad andre skal gøre, hvis du besvimer:
English: This is especially important if you take more than one type of injectable medicine.
Danish: Det er især vigtigt, hvis du tager flere typer injicerbar medicin.
English: The proportion of patients reporting nausea per week at any point during treatment was below 4%.
Danish: Den del af patienterne, der rapporterede kvalme, lå pr. uge på et hvilket som helst tidspunkt i behandlingen på under 4%.
English: Do not use this medicine after the expiry date which is stated on the pen label and carton after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pennens etiket og karton efter ”EXP”.
English: Xultophy which has been frozen must not be used.
Danish: Xultophy, som har været frosset, må ikke anvendes.
English: • If you need more medicine than what is left in your pen, you can split your dose between two pens.
Danish: • Hvis du skal bruge mere medicin end det, der er tilbage i pennen, kan du dele din dosis mellem to penne.
English: It is therefore recommended that the patient always carries sugar-containing products
Danish: Det anbefales derfor, at patienten altid bærer sukkerholdige produkter på sig
English: Primary analysis (3-point MACE) CV Death
Danish: Primær analyse (3-punkt MACE) CV Død
English: Be very careful to calculate correctly if splitting your dose.
Danish: Vær omhyggelig med at regne rigtigt, hvis du deler din dosis.
English: This can only be given by someone who knows how to use it.
Danish: Det må kun gives af en person, der er instrueret i, hvordan det anvendes.
English: Not known (frequency cannot be estimated from the available data)
Danish: Ikke kendt (hyppigheden kan ikke beregnes ud fra tilgængelige data)
English: Time since randomisation (week)
Danish: Tid efter randomisering (uge)
English: • other medicines for diabetes (tablets or injections)
Danish: • andre lægemidler til behandling af diabetes (tabletter eller injektioner)
English: If you discover that you missed your previous dose when it is time to take your next regular scheduled dose, do not take a double dose.
Danish: Hvis du opdager, at du har glemt din tidligere dosis, når det er tid til din næste regelmæssige planlagte dosis, må du ikke tage en dobbeltdosis.
English: Change the needle as described in section 5 and repeat all steps starting with section 1: Prepare your pen with a new needle.
Danish: Udskift nålen som beskrevet i punkt 5, og gentag alle trin med start fra punkt 1: Klargør pennen med en ny nål.
English: GLP-1 is a physiological regulator of appetite and food intake, but the exact mechanism of action is not entirely clear.
Danish: GLP-1 er en fysiologisk regulator af appetit og fødeindtagelse, men den eksakte virkningsmekanisme er ikke fuldstændigt klarlagt.
English: Use in elderly patients (65 years old or over)
Danish: Brug til ældre (65 år eller derover)
English: The efficacy and safety of Xultophy were sustained up to 52 weeks of treatment.
Danish: Virkningen og sikkerheden af Xultophy blev fastholdt i op til 52 ugers behandling.
English: Nausea was reported in 7.8% of patients and was transient in nature for most patients.
Danish: Kvalme blev rapporteret hos 7,8% af patienterne og var af forbigående karakter for de fleste patienter.
English: The following serious side effects may happen with this medicine:
Danish: Følgende alvorlige bivirkninger kan forekomme ved brug af dette lægemiddel:
English: • Always follow your doctor's advice for dose and dose adjustment.
Danish: • Følg altid lægens råd om dosis og dosisjustering.
English: Do not give this medicine to children or adolescents.
Danish: Giv ikke dette lægemiddel til børn eller unge.
English: Xultophy contains two active substances that help your body control your blood sugar:
Danish: Xultophy indeholder to aktive stoffer, som hjælper din krop med at kontrollere blodsukkeret:
English: Name and address of the manufacturer of the biological active substances Novo Nordisk A/S
Danish: Navn og adresse på fremstillerne af de biologisk aktive stoffer Novo Nordisk A/S
English: Diarrhoea and vomiting were reported in 7.5% and 3.9% of patients, respectively.
Danish: Diarré og opkastning blev rapporteret hos henholdsvis 7,5% og 3,9% af patienterne.
English: This makes sure that the solution flows.
Danish: Dette sikrer gennemløb af opløsningen.
English: • how to adjust the dose.
Danish: • hvordan du tilpasser din dosis.
English: • Serious allergic reaction (anaphylactic reaction) (not known: frequency cannot be estimated from the available data).
Danish: • Alvorlig allergisk reaktion (anafylaktisk reaktion) (ikke kendt: hyppigheden kan ikke estimeres ud fra tilgængelige data).
English: If in doubt, take the full dose with a new pen.
Danish: Hvis du er i tvivl, tager du den fulde dosis med en ny pen.
English: Before you use Xultophy for the first time, your doctor or nurse will show you how to inject.
Danish: Før du tager Xultophy første gang, viser lægen eller sygeplejersken dig, hvordan du skal injicere.
English: ATC code: A10AE56
Danish: ATC-kode: A10AE56.
English: • you have had low blood sugar a few times recently.
Danish: • du har haft lavt blodsukker nogle gange på det seneste.
English: • a reminder of the need to report all medication errors irrespective of whether or not they resulted in an adverse event.
Danish: • En påmindelse om nødvendigheden ved at rapportere alle fejlmedicineringer, uanset om de har resulteret i en bivirkning eller ej.
English: Pancreatitis (including necrotising pancreatitis )
Danish: Pankreatitis (herunder nekrotiserende pankreatitis)
English: Administration of rapid-acting insulin should be considered in situations of severe hyperglycaemia.
Danish: Administration af hurtigtvirkende insulin bør overvejes i situationer med alvorlig hyperglykæmi.
English: In both groups 66%-67% achieved HbA1c < 7%.
Danish: I begge grupper opnåede 66%-67% et HbA1c på <7%.
English: It is prescribed when these medicines (used alone or with GLP-1 treatment or with basal insulin) are not enough to control your blood sugar levels.
Danish: Det ordineres, når disse lægemidler (anvendt alene eller med GLP-1 behandling eller sammen med basalinsulin) ikke er nok til at kontrollere dit blodsukkerniveau.
English: The local tissue reactions in the two studies in rabbits and pigs, respectively, were limited to mild inflammatory reactions.
Danish: De lokale vævsreaktioner i de to studier hos henholdsvis kaniner og grise var begrænset til milde inflammatoriske reaktioner.
English: Primary outcome or vital status at end of trial was available for 99.7% and 99.6% of participants randomised to liraglutide and placebo, respectively.
Danish: Det primære resultat eller den vitale status ved afslutningen af studiet var tilgængeligt for 99,7% og 99,6% af deltagerne randomiseret til henholdsvis liraglutid og placebo.
English: Your medicine might be harmful to their health.
Danish: Din medicin kan skade deres helbred.
English: After first opening, the medicinal product can be stored for 21 days at a maximum temperature of 30°C.
Danish: Efter ibrugtagning kan lægemidlet opbevares i 21 dage ved en maksimum temperatur på 30°C.
English: Interaction studies did not show any clinically relevant delay of absorption.
Danish: Interaktionsstudier har ikke påvist nogen klinisk relevant forsinkelse af absorptionen.
English: Do not attach a new needle to your pen until you are ready to take your injection.
Danish: Sæt ikke en ny nål på pennen, før du er klar til at tage din injektion.
English: This is normal, but you must still check the flow.
Danish: Dette er normalt, men du skal stadig kontrollere insulingennemløbet.
English: The pre-filled pen is for use by one person only.
Danish: Den fyldte pen er kun beregnet til én person.
English: EAC: Event adjudication committee.
Danish: EAC: Bedømmelseskomité for hændelser.
English: Xultophy is given once daily by subcutaneous administration.
Danish: Xultophy indgives én gang dagligt ved subkutan administration.
English: Insulin degludec, maximum 50 units allowed
Danish: Insulin degludec, maksimalt 50 enheder tilladt
English: You can select up to 50 dose steps per dose.
Danish: Du kan vælge op til 50 dosistrin per dosis.
English: • growth hormone - for low levels of growth hormone
Danish: • væksthormon - mod lavt niveau af væksthormon
English: • not give you any food or drink - because you may choke.
Danish: • ikke give dig noget at spise eller drikke, da du kan risikere at blive kvalt.
English: • anabolic steroids - such as testosterone
Danish: • anabolske steroider - såsom testosteron
English: If you keep injecting in the same place, these changes can become more severe and affect the amount of medicine your body gets from the pen.
Danish: Hvis du bliver ved med at injicere det samme sted, kan disse ændringer blive mere alvorlige og påvirke den mængde medicin, som kroppen optager efter en injektion.
English: • If it is not possible to use Xultophy at the same time every day, it can be used at a different time of the day.
Danish: • Hvis det ikke er muligt at bruge Xultophy på samme tid hver dag, kan du bruge det på et andet tidspunkt i løbet af dagen.
English: • sulfonamides - for infections
Danish: • sulfonamider - mod infektioner
English: Stop using Xultophy and see a doctor straight away if they become serious.
Danish: Hold op med at bruge Xultophy, og søg straks læge, hvis de bliver alvorlige.
English: General effects from diabetes treatment
Danish: Generelle følger af behandling af diabetes