FrancophonIA/ELRC3.0 huggingface dataset:
English: Examples include: you inject too much insulin, you miss meals or delay them, you do not eat enough, or eat food containing less carbohydrate than normal (sugar and substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT carbohydrates), you lose carbohydrates due to vomiting or diarrhoea, you drink alcohol, particularly if you are not eating much, you are doing more exercise than usual or a different type of physical activity, you are recovering from an injury or operation or other stress, you are recovering from an illness or from fever, you are taking or have stopped taking certain other medicines (see section 2, "Other medicines and Insuman Rapid").
Danish: - tager for meget insulin, - springer måltider over eller udsætter dem, - ikke spiser nok eller spiser mad, der indeholder færre kulhydrater end normalt (sukker og sukkerlignende stoffer kaldes kulhydrater; kunstige sødemidler er imidlertid IKKE kulhydrater), - mister kulhydrater på grund af opkastning og diarré, - drikker alkohol, især hvis du ikke spiser ret meget, - dyrker mere motion end normalt eller udfører en anden form for fysisk aktivitet, - er ved at komme dig efter en skade eller operation eller andre former for stress, - er ved at komme dig efter en sygdom eller feber, - tager eller er holdt op med at tage visse andre lægemidler (se punkt 2 ”Brug af anden medicin sammen med Insuman Rapid”).
English: The Insuman Comb 30 cartridges are to be used only in conjunction with the pens: ClikSTAR, Autopen 24, Tactipen, AllStar , AllStar PRO or JuniorSTAR (see section 4.2 and 4.4).
Danish: Insuman Comb 30 cylinderampullerne må kun anvendes med pennene ClikSTAR, Autopen 24, Tactipen, AllStar, AllStar PRO eller JuniorSTAR (se pkt.
English: In-use cartridges For storage conditions after first opening of the medicinal product, see section 6.3.
Danish: Anbrudte hætteglas For opbevaringsforhold efter anbrud af produktet, se pkt.
English: Insuman Comb 50 SoloStar 100 IU/ml in a pre-filled pen Insuman Comb 50 SoloStar 100 IU/ml in a pre-filled pen must not be mixed with insulins of animal origin or with insulin analogues(see section 4.2, 4.4 and 6.6).
Danish: Insuman Comb 50 SoloStar 100 IE/ml i fyldt pen må ikke blandes med andre insuliner eller med insulin-analoger (se pkt.
English: Hepatobiliary disorders
Danish: Cylinderampuller
English: Examples include: you have not injected your insulin or not injected enough, or if it has become less effective, for example through incorrect storage, your insulin pen does not work properly, you are doing less exercise than usual, you are under stress (emotional distress, excitement), or you have an injury, operation, infection or fever, you are taking or have taken certain other medicines (see section 2, "Other medicines and Insuman Comb 15").
Danish: - ikke har injiceret din insulin eller ikke har injiceret nok, eller hvis det har mistet noget af sin virkning f.eks. på grund af forkert opbevaring, - din insulinpen ikke fungerer rigtigt, - dyrker mindre motion end sædvanlig eller er stresset (følelsesmæssigt ude af balance eller er ophidset), eller hvis du har en skade, er blevet opereret, har en infektion eller feber, - du tager eller har taget visse andre lægemidler (se punkt 2 ”Brug af anden medicin sammen med Insuman Comb 15”).
English: Insuman Comb 25 40 IU/ml suspension for injection
Danish: Insuman Comb 25 40 IE/ml injektionsvæske, suspension human insulin s.c.
English: Insuman Infusat is an insulin preparation with a rapid onset and short duration of action.
Danish: Insuman Infusat er en insulinopløsning med en hurtigt indsættende virkning og kort virkningsvarighed.
English: Important information about some of the ingredients of Insuman Comb 25
Danish: Pakningsstørrelser og yderligere oplysninger Insuman Comb 25 indeholder
English: Do not use this medicine after the expiry date which is stated on the carton and on the label of the cartridge after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på den ydre karton og på hætteglassets etiket efter ”EXP”.
English: Examples include: you inject too much insulin, you miss meals or delay them, you do not eat enough, or eat food containing less carbohydrate than normal (sugar and substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT carbohydrates), you lose carbohydrates due to vomiting or diarrhoea, you drink alcohol, particularly if you are not eating much, you are doing more exercise than usual or a different type of physical activity, you are recovering from an injury or operation or other stress, you are recovering from an illness or from fever, you are taking or have stopped taking certain other medicines (see section 2, "Other medicines and Insuman Infusat").
Danish: - tager for meget insulin, - springer måltider over eller udsætter dem, - ikke spiser nok eller spiser mad, der indeholder færre kulhydrater end normalt (sukker og sukkerlignende stoffer kaldes kulhydrater; kunstige sødemidler er imidlertid IKKE kulhydrater), - mister kulhydrater på grund af opkastning og diarré, - drikker alkohol, især hvis du ikke spiser ret meget, - dyrker mere motion end normalt eller udfører en anden form for fysisk aktivitet, - er ved at komme dig efter en skade eller operation eller andre former for stress, - er ved at komme dig efter en sygdom eller feber, - tager eller er holdt op med at tage visse andre lægemidler (se punkt 2 ”Brug af anden medicin sammen med Insuman Infusat”).
English: Examples include: you inject too much insulin, you miss meals or delay them, you do not eat enough, or eat food containing less carbohydrate than normal (sugar and substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT carbohydrates), you lose carbohydrates due to vomiting or diarrhoea, you drink alcohol, particularly if you are not eating much, you are doing more exercise than usual or a different type of physical activity, you are recovering from an injury or operation or other stress, you are recovering from an illness or from fever, you are taking or have stopped taking certain other medicines (see section 2, "Other medicines and Insuman Comb 30").
Danish: - tager for meget insulin, - springer måltider over eller udsætter dem, - ikke spiser nok eller spiser mad, der indeholder færre kulhydrater end normalt (sukker og sukkerlignende stoffer kaldes kulhydrater; kunstige sødemidler er imidlertid IKKE kulhydrater), - mister kulhydrater på grund af opkastning og diarré, - drikker alkohol, især hvis du ikke spiser ret meget, - dyrker mere motion end normalt eller udfører en anden form for fysisk aktivitet, - er ved at komme dig efter en skade eller operation eller andre former for stress, - er ved at komme dig efter en sygdom eller feber, - tager eller er holdt op med at tage visse andre lægemidler (se punkt 2 ”Brug af anden medicin sammen med Insuman Comb 30”).
English: Insuman Comb 50 100 IU/ml suspension for injection in a cartridge Insulin human
Danish: Insuman Comb 50 100 IE/ml injektionsvæske, suspension human insulin s.c.
English: If you forget to use Insuman Comb 50
Danish: Hvis du har taget for meget Insuman Comb 50
English: Important information about some of the ingredients of Insuman Comb 50
Danish: Pakningsstørrelser og yderligere oplysninger Insuman Comb 50 indeholder
English: Examples include: you inject too much insulin, you miss meals or delay them, you do not eat enough, or eat food containing less carbohydrate than normal (sugar and substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT carbohydrates), you lose carbohydrates due to vomiting or diarrhoea, you drink alcohol, particularly if you are not eating much, you are doing more exercise than usual or a different type of physical activity, you are recovering from an injury or operation or other stress, you are recovering from an illness or from fever, you are taking or have stopped taking certain other medicines (see section 2, "Other medicines and Insuman Comb 50").
Danish: - tager for meget insulin, - springer måltider over eller udsætter dem, - ikke spiser nok eller spiser mad, der indeholder færre kulhydrater end normalt (sukker og sukkerlignende stoffer kaldes kulhydrater; kunstige sødemidler er imidlertid IKKE kulhydrater), - mister kulhydrater på grund af opkastning og diarré, - drikker alkohol, især hvis du ikke spiser ret meget, - dyrker mere motion end normalt eller udfører en anden form for fysisk aktivitet, - er ved at komme dig efter en skade eller operation eller andre former for stress, - er ved at komme dig efter en sygdom eller feber, - tager eller er holdt op med at tage visse andre lægemidler (se punkt 2 ”Brug af anden medicin sammen med Insuman Comb 50”).
English: Examples include: you have not injected your insulin or not injected enough, or if it has become less effective, for example through incorrect storage, you are doing less exercise than usual, you are under stress (emotional distress, excitement), or you have an injury, operation, infection or fever, you are taking or have taken certain other medicines (see section 2, "Other medicines and Insuman Comb°15").
Danish: - ikke har injiceret din insulin eller ikke har injiceret nok, eller hvis det har mistet noget af sin virkning f.eks. på grund af forkert opbevaring, - dyrker mindre motion end sædvanlig eller er stresset (følelsesmæssigt ude af balance eller er ophidset), eller hvis du har en skade, er blevet opereret, har en infektion eller feber, - du tager eller har taget visse andre lægemidler (se punkt 2 ”Brug af anden medicin sammen med Insuman Comb 15”).
English: The Insuman Comb 25 cartridges are to be used only in conjunction with the pens: ClikSTAR, Autopen 24, Tactipen, AllStar, AllStar PRO or JuniorSTAR (see section 4.2 and 4.4).
Danish: Insuman Comb 25 cylinderampullerne må kun anvendes med pennene ClikSTAR, Autopen 24, Tactipen, AllStar, AllStar PRO eller JuniorSTAR (se pkt.
English: Examples include: you inject too much insulin, you miss meals or delay them, you do not eat enough, or eat food containing less carbohydrate than normal (sugar and substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT carbohydrates), you lose carbohydrates due to vomiting or diarrhoea, you drink alcohol, particularly if you are not eating much, you are doing more exercise than usual or a different type of physical activity, you are recovering from an injury or operation or other stress, you are recovering from an illness or from fever, you are taking or have stopped taking certain other medicines (see section 2, "Other medicines and Insuman Comb 15").
Danish: - tager for meget insulin, - springer måltider over eller udsætter dem, - ikke spiser nok eller spiser mad, der indeholder færre kulhydrater end normalt (sukker og sukkerlignende stoffer kaldes kulhydrater; kunstige sødemidler er imidlertid IKKE kulhydrater), - mister kulhydrater på grund af opkastning og diarré, - drikker alkohol, især hvis du ikke spiser ret meget, - dyrker mere motion end normalt eller udfører en anden form for fysisk aktivitet, - er ved at komme dig efter en skade eller operation eller andre former for stress, - er ved at komme dig efter en sygdom eller feber, - tager eller er holdt op med at tage visse andre lægemidler (se punkt 2 ”Brug af anden medicin sammen med Insuman Comb 15”).
English: Based on your life-style and the results of your blood sugar (glucose) tests, your doctor will - determine how much Insuman Infusat per day you will need, how much of this is infused continuously ("basal rate") and how much and when you need additional insulin as an "insulin boost" ("bolus dose"), tell you when to check your blood sugar level, and whether you need to carry out urine tests, tell you when you may need to use a higher or lower dose of Insuman Infusat,
Danish: Alt efter din levevis og resultatet af dine blodsukkermålinger (glucosemålinger) vil din læge - afgøre hvor meget Insuman Basal du skal have om dagen, - fortælle dig, hvornår du skal kontrollere dit blodsukker, og om det er nødvendigt at udføre urinprøver, - fortælle dig, hvornår du eventuelt skal have en større eller mindre dosis Insuman Basal,
English: - If you have any further questions, ask your doctor,pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet.
English: How to use Insuman Infusat
Danish: Sådan skal du tage Insuman Infusat Dosering
English: Important information about some of the ingredients of Insuman Comb 30
Danish: Pakningsstørrelser og yderligere oplysninger Insuman Comb 30 indeholder
English: The final opinion was converted into a Decision by the European Commission on 26 September 2008.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 26. september 2008.
English: In practice this means that in intensive systems all the birds in one house will be treated even if not all exhibit signs of disease.
Danish: I praksis betyder dette, at alle fuglene i intensive systemer i et hus vil blive behandlet, selv om ikke alle viser tegn på sygdom.
English: EMEA/402698/2008-EN
Danish: EMEA/402698/2008-DA
English: The Rapporteur and Co-Rapporteur appointed were Mrs R. Kearsley and Mr G. J. Schefferlie respectively.
Danish: Den udpegede rapportør og medrapportør var henholdsvis R. Kearsley og G. J. Schefferlie.
English: Marketing Authorisations for veterinary medicinal products containing toltrazuril and intended for use in poultry species were previously granted to Bayer HealthCare and/or Ceva Santé Animale in Austria, Belgium, Bulgaria, Cyprus, Czech republic, France, Germany, Greece, Hungary, Ireland, Italy, Poland, Portugal, Romania, Slovakia, Slovenia, the Netherlands and the United Kingdom following national marketing authorisation procedures.
Danish: Der er tidligere blevet udstedt markedsføringstilladelser for veterinærlægemidler indeholdende toltrazuril beregnet til brug i fjerkræ til Bayer Healthcare og/eller Ceva Santé Animale i Østrig, Belgien, Bulgarien, Cypern, Den Tjekkiske Republik, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Nederlandene og Det Forenede Kongerige i henhold til nationale procedurer for markedsføringstilladelser.
English: London, 26 September 2008 EMEA/402698/2008
Danish: London, den 26. september 2008 EMEA/402698/2008
English: The recommended dose and duration of treatment for chickens and turkeys is 7 mg/kg bodyweight per day for two consecutive days.
Danish: Den anbefalede dosis og behandlingsvarighed for høns og kalkuner er 7 mg/kg kropsvægt dagligt i to på hinanden følgende dage.
English: Germany referred the issue to CVMP due to concerns that toltrazuril may present a potential serious risk to the environment on the following grounds:
Danish: Tyskland indbragte spørgsmålet for CVMP på grund af betænkeligheder ved, at toltrazuril kan udgøre en alvorlig risiko for miljøet af følgende grunde:
English: During its 11-13 December 2007 meeting, the CVMP agreed on a two month extension to the date for submission of responses to the list of questions following a request from Bayer HealthCare.
Danish: På mødet den 11.-13. december 2007 accepterede CVMP en forlængelse på to måneder af fristen for fremsendelse af skriftlige svar på spørgsmålene efter en anmodning fra Bayer HealthCare.
English: Toltrazuril is a triazinetrione derivative administered orally in the drinking water for the treatment of coccidiosis in chickens and turkeys.
Danish: Toltrazuril er et triazintrionderivat, der indgives oralt i drikkevandet til behandling af coccidiose hos høns og kalkuner.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amendments to the relevant sections of the Summary of Product Characteristics in Annex III.
Danish: Listen over de berørte lægemiddelnavne fremgår af bilag I. De faglige konklusioner fremgår af bilag II, og ændringerne af de relevante afsnit i produktresuméet fremgår af bilag III.
English: On 31 August 2007 a Community referral under Article 35 of Directive 2001/82/EC, as amended, was initiated by Germany for the nationally authorised product Baycox 2.5 % (solution for poultry).
Danish: Den 31. august 2007 indledte Tyskland i henhold til artikel 35 i direktiv 2001/82/EF, med senere ændringer, en sag for Fællesskabet vedrørende det nationalt godkendte produkt Baycox 2,5 (opløsning til fjerkræ).
English: The arbitration procedure started on 11 October 2007 with the adoption of a list of questions to be put to the Marketing Authorisation Holders.
Danish: Voldgiftsproceduren blev indledt den 11. oktober 2007 med vedtagelse af en liste med spørgsmål, der skulle forelægges indehaverne af markedsføringstilladelserne.
English: • An extended risk assessment on the basis of the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) guidelines fully and clearly demonstrated that veterinary medicinal products containing toltrazuril and intended for use in poultry species must be expected to have impact on the environment.
Danish: • En udvidet risikovurdering på grundlag af retningslinjer fra det internationale samarbejde om harmonisering af tekniske krav til registrering af veterinærlægemidler (VICH) viste fuldt og klart, at veterinærlægemidler, som indeholder toltrazuril og er beregnet til behandling af fjerkræ, må forventes at have en indvirkning på miljøet.
English: The CVMP concluded that the marketing authorisations can be maintained without special warnings in point 5.3 (Environmental properties) of the SPC provided that the product is used under the conditions agreed, i.e. a dose of 7 mg/kg bw on two consecutive days for the treatment of coccidiosis in chickens and turkeys.
Danish: CVMP konkluderede, at markedsføringstilladelserne kan opretholdes uden særlige advarsler i afsnit 5.3 (Miljøoplysninger) i produktresuméet, forudsat at produktet anvendes under de godkendte forhold, dvs. en dosis på 7 mg/kg kropsvægt i to på hinanden følgende dage til behandling af coccidiose hos høns og kalkuner.
English: The Committee further recommended that relevant Marketing Authorisations should be varied in order to harmonise the indications and dosing regimens to bring these in line with those used in the environmental risk assessment.
Danish: Udvalget anbefalede desuden, at de relevante markedsføringstilladelser skulle ændres for at harmonisere indikationerne og dosisangivelserne, så de blev i overensstemmelse med dem, der blev anvendt i miljørisikovurderingen.
English: During its July 2008 meeting, the CVMP, in light of the overall data submitted and the scientific discussion within the Committee, adopted by consensus an opinion concluding that the assessment of the risk presented by toltrazuril and its major metabolite, toltrazuril sulfone, to terrestrial plants and to groundwater demonstrated that use of products containing toltrazuril is acceptable.
Danish: På baggrund af de samlede fremlagte oplysninger og den faglige drøftelse i udvalget vedtog CVMP på mødet i juli 2008 ved konsensus en udtalelse, hvori det konkluderes, at vurderingen af den risiko, som toltrazuril og dets vigtigste metabolit, toltrazurilsulfon, frembyder for terrestriske planter og grundvandet, viste, at brugen af produkter indeholdende toltrazuril er acceptabel.
English: The Marketing Authorisation Holders presented oral explanations to the CVMP on 18 June 2008.
Danish: Indehaverne af markedsføringstilladelsen fremsatte den mundtlige redegørelse for CVMP den 18. juni 2008.
English: However, it was noted that the indications, species and posology in SPCs of some of the authorised products were different and these therefore needed to be amended to bring them in line with the indications and dosing regimens used in the environmental risk assessment.
Danish: Det blev dog bemærket, at indikationerne, arterne og doseringsanvisningen i produktresuméet for nogle af de godkendte produkter var forskellige, og de skulle derfor ændres for at bringe dem i overensstemmelse med de indikationer og doseringsanvisninger, der blev anvendt i miljørisikovurderingen.
English: On 10 October 2007 the European Commission decided that the scope of the referral should include all authorised veterinary medicinal products containing toltrazuril (i.e. reference product and generics thereof) and intended for use in poultry species.
Danish: Den 10. oktober 2007 besluttede Europa-Kommissionen, at indbringelsen skulle omfatte alle godkendte veterinærlægemidler indeholdende toltrazuril (dvs. referenceprodukt og generiske lægemidler heraf) beregnet til behandling af fjerkræ.
English: Therefore the Committee recommended maintaining the Marketing Authorisations for all veterinary medicinal products containing toltrazuril intended for use in chickens and turkeys.
Danish: Udvalget anbefalede derfor opretholdelse af markedsføringstilladelserne for alle veterinærlægemidler indeholdende toltrazuril beregnet til behandling af høns og kalkuner.
English: OPINION FOLLOWING AN ARTICLE 351 REFERRAL FOR ALL AUTHORISED VETERINARY MEDICINAL PRODUCTS CONTAINING TOLTRAZURIL INTENDED FOR USE IN POULTRY SPECIES International Non-Proprietary Name (INN): Toltrazuril
Danish: UDTALELSE SOM FØLGE AF EN INDBRINGELSE I HENHOLD TIL ARTIKEL 351 FOR ALLE GODKENDTE VETERINÆRLÆGEMIDLER INDEHOLDENDE TOLTRAZURIL TIL BEHANDLING AF FJERKRÆ Internationalt fællesnavn (INN): Toltrazuril
English: The date set for submission of written responses by the Marketing Authorisation Holders was 14 January 2008.
Danish: Fristen for fremsendelse af en skriftlig redegørelse fra indehaverne af markedsføringstilladelsen blev fastsat til den 14. januar 2008.
English: Written explanations were provided by the Marketing Authorisation Holders on 18 March 2008.
Danish: Indehaveren af markedsføringstilladelsen fremsendte en skriftlig besvarelse af spørgsmålene den 18. marts 2008.
English: 05 June 2015
Danish: Den 5. juni 2015
English: The usual starting dose is 10 mg taken twice a day, preferably in the morning and in the evening.
Danish: Den normale startdosis er 10 mg to gange dagligt, der helst skal tages om morgenen og om aftenen.
English: The companies that market these medicines are Sanofi-Aventis and Merck KGaA.
Danish: De virksomheder, der markedsfører disse lægemidler, er Sanofi-Aventis og Merck KGaA.
English: Ikorel and Dancor are marketed in the following EU Member States: Austria, Denmark, France, Ireland, the Netherlands, Portugal, and the United Kingdom.
Danish: Ikorel og Dancor markedsføres i følgende EU-medlemsstater: Østrig, Danmark, Frankrig, Irland, Nederlandene, Portugal og Det Forenede Kongerige.
English: Ikorel and Dancor have been authorised in the EU via national procedures.
Danish: Ikorel og Dancor er godkendt i EU via nationale procedurer.
English: 4.1 Therapeutic indication
Danish: Terapeutiske indikationer
English: The European Commission issued an EU-wide legally binding decision to implement these changes on 05 June 2015.
Danish: Med henblik på at gennemføre disse ændringer vedtog Europa-Kommissionen den 5. juni 2015 en afgørelse, der er retligt bindende i hele EU.
English: What are Ikorel and Dancor?
Danish: Hvad er Ikorel og Dancor?
English: On 26 March 2015, the European Medicines Agency completed a review of Ikorel and Dancor.
Danish: Den 26. marts 2015 afsluttede Det Europæiske Lægemiddelagentur en revurdering af Ikorel og Dancor.
English: In patients particularly predisposed to headaches, the starting dose can be lowered to 5 mg twice a day.
Danish: Hos patienter med særlig tilbøjelighed til hovedpine kan startdosis sættes ned til 5 mg to gange dagligt.
English: Ikorel and Dancor should be used with caution in patients taking the following medicines:
Danish: Ikorel og Dancor bør anvendes med forsigtighed hos patienter, der tager følgende lægemidler:
English: The CHMP also harmonised other sections of the SmPC including sections 4.5 (interactions with other medicinal products), 4.8 (undesirable effects) and 5.1 (pharmacodynamic properties).
Danish: CHMP harmoniserede desuden andre punkter i produktresuméet, herunder punkt 4.5 (interaktion med andre lægemidler), 4.8 (bivirkninger) og 5.1 (farmakodynamiske egenskaber).