FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, the CHMP's view was that, as for Humalog, the benefits of Insulin lispro Sanofi outweigh its risks and recommended that it be given marketing authorisation.
Danish: CHMP var derfor af den opfattelse, at fordelene ved Insulin lispro Sanofi overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The active substance in Insulin lispro Sanofi is a form of insulin which is absorbed more quickly by the body than human regular insulin, and can therefore act faster.
Danish: Det aktive stof i Insulin lispro Sanofi er en form for insulin, der optages hurtigere af kroppen end almindeligt humant insulin og derfor virker hurtigere.
English: This is a summary of the European public assessment report (EPAR) for Insulin lispro Sanofi.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Insulin lispro Sanofi.
English: It contains the active substance insulin lispro.
Danish: Det indeholder det aktive stof insulin lispro.
English: Insulin lispro Sanofi is a medicine used to control blood glucose (sugar) levels in adults and children with diabetes who need insulin.
Danish: Insulin lispro Sanofi er et lægemiddel, der anvendes til at regulere blodsukkeret (indholdet af glukose) hos voksne og børn med sukkersyge, der behøver insulin.
English: The dose of Insulin lispro Sanofi is worked out for each patient and depends on the patient's blood glucose level.
Danish: Dosis af Insulin lispro Sanofi beregnes for hver enkelt patient og afhænger af patientens blodsukker.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements for biosimilar medicines, Insulin lispro Sanofi has a highly similar structure, purity and biological activity to Humalog and is distributed in the body in the same way.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Insulin lispro Sanofi og Humalog svarer til hinanden hvad angår struktur, renhed og biologisk aktivitet, og at de fordeles i kroppen på samme måde.
English: Insulin lispro Sanofi may cause hypoglycaemia (low blood glucose levels) and must not be given to patients whose blood glucose is already low.
Danish: Insulin lispro Sanofi kan forårsage lavt blodsukker (hypoglykæmi) og må ikke gives til patienter, der i forvejen har lavt blodsukker.
English: For more information about treatment with Insulin lispro Sanofi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Insulin lispro Sanofi, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Two further studies in a total of 1,012 patients compared Insulin lispro Sanofi with Humalog and found them to be similarly effective at reducing blood levels of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose levels are controlled over time.
Danish: I to yderligere undersøgelser med i alt 1 012 patienter blev Insulin lispro Sanofi sammenlignet med Humalog, og de to lægemidler blev fundet at have samme virkning hvad angår mindskelse af blodets indhold af stoffet glykosyleret hæmoglobin (HbA1c), som er et mål for, hvor godt blodsukkeret er reguleret over tid.
English: Laboratory studies comparing Insulin lispro Sanofi with the reference medicine Humalog have shown that the active substance in Insulin lispro Sanofi is highly similar in terms of structure, purity and biological activity to that of Humalog.
Danish: Laboratorieundersøgelser, hvor Insulin lispro Sanofi er sammenlignet med referencelægemidlet Humalog, har vist, at det aktive stof i Insulin lispro Sanofi i meget høj grad svarer til Humalog hvad angår opbygning, renhed og biologisk aktivitet.
English: Insulin lispro Sanofi is given as an injection under the skin in the upper arm, thigh, buttock or belly.
Danish: Insulin lispro Sanofi gives som indsprøjtning under huden i overarmen, låret, balden eller maveskindet.
English: Insulin lispro Sanofi is a ‘biosimilar medicine'.
Danish: Insulin lispro Sanofi er et "biosimilært" lægemiddel.
English: For the full list of all side effects and restrictions with Insulin lispro Sanofi, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Insulin lispro Sanofi fremgår af indlægssedlen.
English: What measures are being taken to ensure the safe and effective use of Insulin lispro Sanofi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Insulin lispro Sanofi?
English: For practical information about using Insulin lispro Sanofi, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Insulin lispro Sanofi, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The reference medicine for Insulin lispro Sanofi is Humalog 100 U/ml solution.
Danish: Referencelægemidlet for Insulin lispro Sanofi er Humalog, opløsning, 100 E/ml.
English: It is not intended to provide practical advice on how to use Insulin lispro Sanofi.
Danish: Det er ikke en praktisk vejledning i, hvordan Insulin lispro Sanofi bør anvendes.
English: Other information about Insulin lispro Sanofi
Danish: Andre oplysninger om Insulin lispro Sanofi
English: What is Insulin lispro Sanofi and what is it used for?
Danish: Hvad er Insulin lispro Sanofi, og hvad anvendes det til?
English: What are the risks associated with Insulin lispro Sanofi?
Danish: Hvilke risici er der forbundet med Insulin lispro Sanofi?
English: Why is Insulin lispro Sanofi approved?
Danish: Hvorfor blev Insulin lispro Sanofi godkendt?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Insulin lispro Sanofi 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 Insulin lispro Sanofi.
English: How does Insulin lispro Sanofi work?
Danish: Hvordan virker Insulin lispro Sanofi?
English: What benefits of Insulin lispro Sanofi have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Insulin lispro Sanofi?
English: How is Insulin lispro Sanofi used?
Danish: Hvordan anvendes Insulin lispro Sanofi?
English: EU Number
Danish: EU-Nummer
English: Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Dyreart Administrationsvej
English: Invented Name
Danish: Produktnavn
English: Target species
Danish: Spot-on
English: What is Yvidually?
Danish: Hvad er Yvidually?
English: EMA/265750/2012 Rev. 1 EMEA/H/A-29/1330
Danish: Den 28. september 2012 EMA/265750/2012 rev. 1 EMEA/H/A-29/1330
English: The European Commission issued a decision on 28 September 2012.
Danish: Europa-Kommissionen traf en afgørelse den 28. september 2012.
English: France, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom).
Danish: Ungarn, Island, Irland, Italien, Letland, Litauen, Luxembourg, Malta, Norge, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Spanien, Sverige og Det Forenede Kongerige).
English: Why was Yvidually reviewed?
Danish: Hvorfor blev Yvidually vurderet igen?
English: However, the Member States were not able to reach an agreement and the Netherlands referred the matter to the CHMP for arbitration on 23 February 2012.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og Nederlandene indbragte sagen for CHMP til voldgift den 23. februar 2012.
English: France was also concerned that the tablet dispenser had not been used in the main clinical studies.
Danish: Frankrig var desuden betænkelig ved, at tabletdispenseren ikke var blevet anvendt i de kliniske hovedundersøgelser.
English: On 19 April 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Yvidually and associated names.
Danish: Den 19. april 2012 gennemførte Det Europæiske Lægemiddelagentur en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) vedrørende godkendelsen af lægemidlet Yvidually og relaterede navne.
English: This medicine will be marketed also as Flexyess.
Danish: Lægemidlet vil desuden blive markedsført under navnet Flexyess.
English: Yvidually is a combined contraceptive pill.
Danish: Yvidually er en kombineret p-pille.
English: Yvidually will be available as tablets in an automated tablet dispenser device with a reminder function for when the next pill has to be taken.
Danish: Yvidually vil blive leveret som tabletter i en automatisk tabletdispenser med påmindelsesfunktion, der gør brugeren opmærksom på, hvornår næste tablet skal tages.
English: Based on evaluation of the available data and the scientific discussion within the Committee, the CHMP concluded that the contraceptive effectiveness during an extended use had been demonstrated.
Danish: Efter vurdering af de foreliggende data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at den svangerskabsforebyggende effektivitet under forlænget brug var blevet påvist.
English: The option of a tablet-free interval at any time during day 25 to 120 of the treatment cycle is also allowed.
Danish: Desuden er der mulighed for en tabletfri pause på et vilkårligt tidspunkt fra dag 25 til dag 120 i behandlingscyklussen.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the Netherlands) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Germany, Greece, Finland,
Danish: Dette sker med henblik på udstedelse af en markedsføringstilladelse, der ud over denne stat er gyldig i andre medlemsstater (de “berørte medlemsstater”, her Østrig, Belgien, Bulgarien, Cypern, Tjekkiet, Danmark, Estland, Tyskland, Grækenland, Finland, Frankrig,
English: The grounds for the referral were concerns by France about the effectiveness of the proposed extended use of the medicine and the irregular bleeding episodes that might occur during the days of intake of the pill.
Danish: Begrundelsen for indbringelsen var Frankrigs betænkeligheder vedrørende effektiviteten af den ansøgte forlængede brug af lægemidlet og de episoder med uregelmæssige blødninger, der kunne forekomme i perioden med tabletindtagelse.
English: The CHMP also noted that the concerns over the tablet dispenser had been adequately addressed, as an additional study provided by the company showed that women find the dispenser easy to use and that there were no problems with posology compliance.
Danish: CHMP bemærkede desuden, at betænkelighederne vedrørende tabletdispenseren var blevet tilfredsstillende imødekommet, idet virksomheden havde forelagt en supplerende undersøgelse, der viste, at kvinder finder dispenseren let at bruge, og at der ikke var problemer med at overholde doseringen.
English: While different bleeding patterns had been reported during the days of pill intake, these bleeding episodes seemed to be well tolerated.
Danish: Der var blevet beskrevet en række forskellige blødningsmønstre i dagene med tabletindtagelse, men disse blødningsepisoder syntes at blive tålt godt.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Yvidually outweigh its risks, and the marketing authorisation can be granted in all EU Member States as well as Iceland and Norway.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Yvidually er større end risiciene, og at der kan udstedes markedsføringstilladelse i alle EU-medlemsstater samt Island og Norge.
English: The CHMP therefore concluded that the benefits of Yvidually outweigh its risks, and therefore the marketing authorisation for Yvidually should be granted in all concerned Member States.
Danish: CHMP konkluderede derfor, at fordelene ved Yvidually overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse i alle de berørte medlemsstater.
English: It contains two active substances, ethinylestradiol and drospirenone, which are derived from natural hormones produced in the ovaries: ethinylestradiol is derived from oestrogen and drospirenone is derived from progesterone.
Danish: Begge stoffer er afledt af naturlige hormoner, der produceres i æggestokkene: Ethinylestradiol er afledt af østrogen, og drospirenon er afledt af progesteron.
English: Bayer B.V. submitted Yvidually to the Netherlands medicines regulatory agency for a decentralised procedure.
Danish: søgte Yvidually godkendt hos den nederlandske lægemiddelstyrelse ved en decentral procedure.
English: Yvidually works by changing the body's hormonal balance to prevent ovulation, by altering the mucus in the cervix (neck of the womb) and by thinning the endometrium (the lining of the womb).
Danish: Yvidually virker ved at ændre kroppens hormonbalance, så ægløsning hindres ved, at slimen i livmoderhalsen ændres, og livmoderslimhinden bliver tyndere.
English: Yvidually is an ‘extended use' oral contraceptive, which means that it can be taken daily for up to 120 days.
Danish: Det betyder, at det kan tages dagligt i op til 120 dage.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Glidipion on 15 March 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Glidipion den 15. marts 2012.
English: The recommended starting dose of Glidipion is 15 or 30 mg once a day.
Danish: Den anbefalede startdosis af Glidipion er 15 eller 30 mg én gang dagligt.
English: The full EPAR for Glidipion can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Glidipion findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Glidipion.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Glidipion.
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 Glidipion.
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 Glidipion.
English: This means that Glidipion is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Danish: Det betyder, at Glidipion er identisk med et “referencelægemiddel”, der allerede er godkendt i Den Europæiske Union (EU), og som hedder Actos.
English: This dose may need to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar) control is needed.
Danish: Denne dosis skal muligvis øges efter én til to uger til en dosis på op til 45 mg én gang dagligt, hvis der er behov for en bedre kontrol af glukosekoncentrationen (blodsukkerkoncentrationen) i blodet.
English: The active substance in Glidipion, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Danish: Det aktive stof i Glidipion, pioglitazon, gør cellerne (fedt, muskel og lever) mere følsomme over for insulin, hvilket betyder, at kroppen bedre udnytter den insulin, den selv danner.
English: Treatment with Glidipion should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Danish: Behandlingen med Glidipion skal tages op til fornyet vurdering efter tre til seks måneder og afbrydes hos patienter, der ikke får tilstrækkelig gavn af behandlingen.
English: For more information about treatment with Glidipion, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Glidipion, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Glidipion is a ‘generic medicine'.
Danish: Glidipion er et “generisk lægemiddel”.
English: Glidipion is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Danish: Glidipion anvendes til behandling af type 2-diabetes hos voksne (i alderen 18 år og derover), især overvægtige.
English: Glidipion is a medicine that contains the active substance pioglitazone.
Danish: Glidipion er et lægemiddel, der indeholder det aktive stof pioglitazon.
English: The CHMP concluded that, in accordance with EU requirements, Glidipion has been shown to have comparable quality and to be bioequivalent to Actos.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Glidipion er af sammenlignelig kvalitet og er bioækvivalent med Actos.
English: Other information about Glidipion
Danish: Andre oplysninger om Glidipion
English: Therefore, the CHMP's view was that, as for Actos, the benefits outweigh the identified risks.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Actos.
English: The Committee recommended that Glidipion be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Glidipion.
English: Because Glidipion is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Danish: Da Glidipion er et generisk lægemiddel, har patientundersøgelserne været begrænset til test for at fastslå, at det er bioækvivalent med referencelægemidlet Actos.
English: Glidipion should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease).
Danish: Glidipion bør ikke anvendes til patienter i dialyse (en blodrensningsteknik, som anvendes til personer med nyresygdom).
English: Because Glidipion 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 Glidipion er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Glidipion can also be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Danish: Glidipion kan også anvendes sammen med insulin til patienter, der ikke er tilfredsstillende reguleret med insulin alene, og som ikke kan tage metformin.
English: What is the risk associated with Glidipion?
Danish: Hvilken risiko er der forbundet med Glidipion?
English: Why has Glidipion been approved?
Danish: Hvorfor blev Glidipion godkendt?
English: Glidipion is used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Danish: Glidipion anvendes som enebehandling til patienter, hos hvem metformin (et andet lægemiddel mod diabetes) ikke er egnet.
English: Glidipion can also be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of antidiabetes medicine) when metformin is not suitable (‘dual therapy').
Danish: Glidipion kan også anvendes i kombination med metformin til patienter, som ikke er tilfredsstillende reguleret med metformin alene, eller sammen med et sulfonylurinstof (en anden type lægemiddel mod diabetes), hvor metformin ikke er egnet (“dobbelt terapi”).
English: Glidipion can also be used together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite dual therapy by mouth (‘triple therapy').
Danish: Glidipion kan desuden anvendes sammen med både metformin og et sulfonylurinstof til patienter, som ikke er tilfredsstillende reguleret trods dobbelt terapi med orale lægemidler (“tredobbelt terapi”).
English: What is Glidipion?
Danish: Hvad er Glidipion?
English: What is Glidipion used for?
Danish: Hvad anvendes Glidipion til?
English: How has Glidipion been studied?
Danish: Hvordan blev Glidipion undersøgt?
English: How is Glidipion used?
Danish: Hvordan anvendes Glidipion?
English: How does Glidipion work?
Danish: Hvordan virker Glidipion?
English: Severe humoral or cellular (primary or acquired) immunodeficiency, e.g. severe combined immunodeficiency, agammaglobulinemia and AIDS or symptomatic HIV infection or an age-specific CD4+ T-lymphocyte percentage in children below 12 months: CD4+ <25%; children between 12-35 months: CD4+ < 20%; children between 36-59 months: CD4+ < 15% (see section 4.4).
Danish: Alvorlig humoral eller cellulær (primær eller erhvervet) immundefekt, f.eks. alvorlig kombineret immundefekt, agammaglobulinæmi, aids, symptomgivende hiv-infektion eller en aldersspecifik CD4+ T-lymfocytprocent hos børn under 12 måneder: CD4+ < 25 %; hos børn i alderen 12-35 måneder: CD4+ < 20 %; hos børn i alderen 36-59 måneder: CD4+ < 15 % (se pkt.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before the vaccination is given.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apoteket til råds, før du bliver vaccineret.
English: Women who intend to become pregnant should be advised to delay.
Danish: Kvinder, der planlægger at blive gravide, skal rådes til at udsætte dette.
English: - if you or your child has any illness (such as Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)) or takes any medicine that weakens the immune system.
Danish: - hvis du eller dit barn har en sygdom (f.eks. humant immundefekt-virus (hiv) eller erhvervet immundefektsyndrom (aids)) eller tager medicin, der svækker immunsystemet.
English: The wording below should be inserted:
Danish: Nedennævnte tekst skal indsættes:
English: Vaccination may be considered in patients with selected immune deficiencies where the benefits outweigh the risks (e.g. asymptomatic HIV subjects, IgG subclass deficiencies, congenital neutropenia, chronic granulomatous disease, and complement deficiency diseases).
Danish: Vaccination kan overvejes hos personer med udvalgte immundefekter, hvor fordelene vægtes højere end risiciene (f.eks. symptomfrie hiv-patienter og personer med IgG-subklassedefekt, medfødt neutropeni, kronisk granulomatøs sygdom eller komplementmangelsygdomme).
English: During this time you should use an effective method of birth control to avoid pregnancy.
Danish: Du skal i denne periode bruge en sikker præventionsmetode, så du undgår graviditet.
English: Pregnant women should not be vaccinated with [PRODUCT NAME].
Danish: Gravide kvinder bør ikke vaccineres med [PRODUKT NAVN].
English: Section 4.4 Special warnings and precautions for use The wording on pregnancy and breastfeeding should be deleted.
Danish: Punkt 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Informationen om graviditet og amning skal slettes.
English: Even if a theoretical risk cannot be excluded yet, no cases of congenital rubella syndrome have been reported in more than 3500 susceptible women who were unknowingly in early stages of pregnancy when vaccinated with rubella containing vaccines.
Danish: Selv om en teoretisk risiko endnu ikke kan udelukkes, er der ikke set medfødt rubellasyndrom hos børn af flere end 3.500 disponerede kvinder, som uden kendskab til deres tidlige stadie af graviditeten blev vaccineret med en røde hunde-vaccine.