FrancophonIA/ELRC3.0 huggingface dataset:
English: The protocol of drug utilisation study in order to better characterise prescribing practices for the medicinal products during typical clinical use in representative groups of prescribers and to assess main reasons for prescription should be also be submitted as part of the RMP.
Danish: Som en del af risikostyringsplanen forelægges desuden protokollen til undersøgelse af lægemiddelanvendelsen, hvis formål er bedre karakterisering af typisk ordinationspraksis for lægemidlerne hos repræsentative grupper af ordinerende læger og fastlæggelse af hovedgrundene til ordination.
English: Furthermore, concomitant use of another hormonal contraceptive being reported as an additional suspected drug was documented in 21 (2.2%) of received TE cases; 20 patients received concomitantly various COCs and one case reported concomitant intrauterine device (IUD) (levonorgestrel-releasing intrauterine system) use.
Danish: I 21 (2,2 %) af de indberettede tilfælde af tromboemboli blev der desuden samtidig anvendt et andet hormonalt antikonceptionsmiddel, som blev indberettet som endnu et mistænkt lægemiddel.
English: Finally educational material for prescribers on the risk of VTEs and ATEs as well for patients for awareness of the VTEs and ATEs symptoms have been requested by PRAC for submission within the risk management plan.
Danish: Endelig anmodede PRAC om, at der sammen med risikostyringsplanen forelægges oplysningsmateriale til ordinerende læger om venøs og arteriel tromboemboli og til patienterne for at henlede opmærksomheden på symptomer ved venøs og arteriel tromboemboli.
English: A total of 175 cases (all serious, medically confirmed (38.3%, n=67 in total) and non-medically confirmed (61.7%, n=108 in total)) reporting thrombotic / thromboembolic events (TE) irrespective of their nature (arterial, venous and unspecified) occurring in female patients in association with CPA/EE (2mg/0.035mg) were received by the MAH from worldwide sources additionally to the 968 TE cases presented in the main analysis.
Danish: Ud over de 968 tilfælde af tromboemboli, der beskrives i hovedanalysen, modtog indehaveren af markedsføringstilladelsen fra kilder verden over i alt 175 indberetninger om trombotiske/tromboemboliske hændelser (TE) (alle alvorlige, lægeligt bekræftede (38,3 %, n=67 i alt) uanset art (arterielle, venøse eller uspecificerede)) hos kvindelige patienter i for bindelse med CPA/EE (2 mg/0,035 mg).
English: This translates into reporting rate of 1.05 ADR reports per 100,000 women-years with CPA/EE (2mg/0.035mg).
Danish: Dette svarer til en indberetningshyppighed på 1,05 bivirkningsindberetninger per 100 000 kvindeår med CPA/EE (2 mg/0,035 mg).
English: This translates into reporting rate of 0.07 ADR reports per 100,000 women-years with CPA/EE (2mg/0.035mg).
Danish: Dette svarer til en indberetningshyppighed på 0,07 bivirkningsindberetninger per 100 000 kvindeår med CPA/EE (2 mg/0,035 mg).
English: A total of 1094 users of CPA-containing preparations were enrolled in the study, representing 5.5% of the total study population based on 6th Interim Report of this on-going study.
Danish: Undersøgelsen har ifølge den 6. interimsrapport inkluderet i alt 1 094 brugere af præparater indeholdende CPA, svarende til 5,5 % af hele undersøgelsespopulationen.
English: This translates into a global spontaneous reporting rate of 1.2 non-fatal TE reports per 100,000 women-years with CPA/EE (2mg/0.035mg).
Danish: Den tilsvarende globale spontane indberetningshyppighed er 1,2 indberetninger af tilfælde af tromboemboli uden dødelig udgang per 100 000 kvindeår med CPA/EE (2 mg/0,035 mg).
English: This translates into the global spontaneous reporting rate of 0.10 fatal TE reports per 100,000 womenyears with CPA/EE (2mg/0.035mg).
Danish: Den tilsvarende globale spontane indberetningsfrekvens er 0,10 indberetninger af dødelig tromboemboli pr. 100 000 kvindeår med CPA/EE (2 mg/0,035 mg).
English: An increased risk for thrombotic / thromboembolic events (that may be fatal in 1-2% of cases) is listed in the Core company data sheet (CCDS) for CPA/EE (2mg/0.035mg).
Danish: I virksomhedens centrale datablad (CCDS) for CPA/EE (2 mg/0,035 mg) angives øget risiko for trombotiske /tromboemboliske hændelser (som kan være dødelige i 1-2 % af tilfældene).
English: The PRAC concluded that the benefit-risk balance of cyproterone acetate/ethinylestradiol (2mg/0.035mg) containing medicinal products is favourable as the benefits continue to outweigh the risks in the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age.
Danish: PRAC konkluderede, at benefit/risk-forholdet for lægemidler indeholdende cyproteronacetat/ethinylestradiol (2 mg/0,035 mg) er gunstigt, da fordelene fortsat overstiger risiciene til behandling af moderat til svær acne i forbindelse med androgenfølsomhed (med eller uden seborré) og/eller hirsutisme hos kvinder i den fødedygtige alder. Lægemidlerne bør kun anvendes til behandling af acne, når topisk behandling eller systemisk antibiotisk behandling har slået fejl.
English: • The PRAC is of the opinion that the benefits of cyproterone acetate/ ethinylestradiol (2mg/0.035mg) containing medicinal products continue to outweigh the risks in the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhea) and/or hirsutism, in women of reproductive age.
Danish: • PRAC er af den opfattelse, at fordelene ved lægemidler indeholdende cyproteronacetat/ethinylestradiol (2 mg/0,035 mg) fortsat overstiger risiciene til behandling af moderat til svær acne forbundet med androgenfølsomhed (med eller uden seborré) og/eller hirsutisme hos kvinder i den fødedygtige alder. Lægemidlerne bør kun anvendes til behandling af acne, når topisk behandling eller systemisk antibiotisk behandling har slået fejl,
English: The PRAC is of the opinion that the benefits of CPA/EE (2mg/0.035mg) containing medicinal products continue to outweigh the risks in the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhea) and/or hirsutism, in women of reproductive age.
Danish: PRAC finder, at fordelene ved lægemidler indeholdende CPA/EE (2 mg/0,035 mg) fortsat overstiger risiciene til behandling af moderat til svær acne forbundet med androgenfølsomhed (med eller uden seborré) og/eller hirsutisme hos kvinder i den fødedygtige alder. Lægemidlerne bør kun anvendes til behandling af acne, når topisk behandling eller systemisk antibiotisk behandling har slået fejl.
English: Palombo-Kinne E, et al., 2009) comparing CPA/EE (2mg/0.035mg) with dienogest containing combined oral contraceptive and with norgestimate containing combined oral contraceptive also showed similar efficacy.
Danish: To undersøgelser viste ligeledes samme virkning af CPA/EE (2 mg/0,035 mg) som af et kombineret oralt antikonceptionsmiddel indeholdende dienogest og af et kombineret oralt antikonceptionsmiddel indeholdende norgestimat (A18566, 2004, Palombo-Kinne E, et al.,2009).
English: The total number of patients exposed in these studies amounts to
Danish: I alt omfatter disse undersøgelser 2 455 eksponerede patienter.
English: 1 July 2010
Danish: 1. juli 2010
English: Beechinor, respectively.
Danish: Beechinor udpeget.
English: Committee for medicinal products for veterinary use (CVMP)
Danish: Udvalget for Veterinærlægemidler (CVPM)
English: The final opinion was converted into a Decision by the European Commission on 1 July 2010.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 1. juli
English: The referral procedure started on 13 May 2009.
Danish: Indbringelsesproceduren indledtes den 13. maj 2009.
English: The detailed grounds for the re-examination were submitted to the Agency by 18 January 2010 and the procedure started on 19 January 2010.
Danish: De detaljerede begrundelser for revurderingen blev fremsendt til agenturet den 18. januar 2010, og proceduren blev indledt den 19. januar 2010.
English: The rapporteur and co-rapporteur appointed were: Mrs R. Kearsley and Dr J.G.
Danish: Som rapportør og medrapportør blev henholdsvis R. Kearsley og dr. J.G.
English: During its meeting of 8-10 December 2009 the CVMP appointed Dr J. Hederová as the rapporteur and Dr J. Bureš as the co-rapporteur for the re-examination procedure.
Danish: På mødet den 8.-10. december 2009 udpegede CVMP dr. J. Hederová som rapportør og dr. J. Bureš som medrapportør for overnævnte revurderingsprocedure.
English: Written explanations were provided by the applicants/marketing authorisation holders on 18 August 2009.
Danish: Ansøgerne/indehaverne af markedsføringstilladelser fremsendte den 18. august 2009 en skriftlig besvarelse af spørgsmålene.
English: The aim of the referral was to ensure that the products identified are indicated only for appropriate conditions, that dosage strategies are set to minimise the likelihood of development of antimicrobial resistance and that appropriate withdrawal periods are fixed to guarantee consumer protection.
Danish: Formålet med indbringelsen var at sikre, at de identificerede lægemidler kun er indiceret til relevante tilstande, at der fastsættes doseringsstrategier med henblik på at minimere risikoen for, at der udvikles antimikrobiel resistens, og at der fastsættes en passende tilbageholdelsestid for at sikre forbrugerbeskyttelse.
English: The issues considered during the re-examination related to the evaluation of the prudent use warnings for specific products and not to the overall CVMP recommendation.
Danish: De spørgsmål, der blev behandlet under revurderingen, vedrørte evalueringen af advarslerne og forsigtighedsreglerne vedrørende brugen for specifikke lægemidler, og ikke den overordnede anbefaling fra CVMP.
English: The CVMP conclusions relating to the specific products that were the focus of the re-examination procedure are reflected in Annex II (Scientific conclusions) of the CVMP opinion.
Danish: CVMP's konklusioner vedrørende de specifikke lægemidler, der blev behandlet under revurderingsproceduren, fremgår af bilag II (Faglige konklusioner) til CVMP's udtalelse.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended summary of product characteristics and package leaflet in the Annex III.
Danish: Listen over de berørte lægemiddelnavne fremgår af bilag I. De faglige konklusioner fremgår af bilag II, og det ændrede produktresumé og den ændrede indlægsseddel fremgår af bilag III.
English: On 23 November 2009, Ascor Chimici s.r.l., and on 3 December 2009, Ceva Santé Animale notified the Agency of their intention to request the re-examination of the CVMP opinion adopted on 11 November
Danish: og Ceva Santé Animale underrettede henholdsvis den 23. november 2009 og den 3. december 2009 agenturet om, at de havde til hensigt at anmode om en revurdering af CVMP's udtalelse vedtaget den 11. november 2009.
English: On 28 April 2009, the European Commission presented to the Agency a referral notification under Article 35 of Directive 2001/82/EC, regarding all veterinary medicinal products containing quinolones including fluoroquinolones intended for use in food-producing species.
Danish: Den 28. april 2009 underrettede Europa-Kommissionen agenturet om indbringelse af en sag i henhold til artikel 35 i direktiv 2001/82/EF vedrørende alle veterinærlægemidler indeholdende quinoloner, herunder fluoroquinoloner, beregnet til brug hos arter bestemt til levnedsmiddelproduktion.
English: On 15 May 2009 the European Commission submitted a revised notification to the Agency, in which it agreed to the CVMP proposal to take a step-wise approach to achieve the aim mentioned above and to limit the scope of the current referral procedure to the harmonisation of the warnings on prudent use included in the Summary of Product Characteristics (SPCs) for these classes of veterinary medicinal product in line with those recommended in the CVMP document “Reflection paper on the use of fluoroquinolones in food-producing animals - Precautions for use in the SPC regarding prudent use guidance (EMEA/CVMP/416168/2006)”.
Danish: Den 15. maj 2009 fremsendte Europa-Kommissionen en revideret meddelelse om indbringelsen til agenturet, hvori den tilsluttede sig CVMP's forslag om en trinvis tilgang til at nå ovennævnte mål og begrænse indbringelsens omfang til harmonisering af advarslerne og forsigtighedsreglerne vedrørende brugen i produktresuméet for disse grupper veterinærlægemidler i henhold til dem, der anbefales i CVMP-dokumentet "Reflection paper on the use of fluoroquinolones in food-producing animalsPrecautions for use in the SPC regarding prudent use guidance (EMEA/CVMP/416168/2006)".
English: On 9 March 2010 the CVMP adopted a final opinion confirming the recommendation, included in its opinion of 11 November 2009, that variations are necessary to the terms of the marketing authorisations for veterinary medicinal products containing (fluoro)quinolones intended for foodproducing species where it has been identified that the SPC and package leaflet have not been updated in line with the precautionary phrases in the CVMP “Reflection paper on the use of fluoroquinolones in food-producing animals - Precautions for use in the SPC regarding prudent use guidance” (EMEA/CVMP/416168/2006).
Danish: Den 9. marts 2010 vedtog CVMP en endelig udtalelse, hvori udvalget bekræftede anbefalingen i udtalelsen af 11. november 2009 om, at der var behov for en ændring af betingelserne for markedsføringstilladelserne til veterinærlægemidler indeholdende (fluoro)quinoloner beregnet til brug hos arter bestemt til levnedsmiddelproduktion i de tilfælde, hvor produktresuméet og indlægssedlen ikke var blevet ajourført i henhold til sætningerne om forsigtighedsregler i CVMP's "Reflection paper on the use of fluoroquinolones in food-producing animals - Precautions for use in the SPC regarding prudent use guidance" (EMEA/CVMP/416168/2006).
English: Based on the rapporteurs' assessment of the available data, the CVMP adopted, on 11 November 2009, an opinion recommending variations of the marketing authorisations for medicinal products containing (fluoro)quinolones intended for food-producing species in order to amend the SPCs and package leaflets in those cases where these were not in line with the prudent use warnings recommended in the CVMP reflection paper on the use of fluoroquinolones in food-producing animals - Precautions for use in the SPC regarding prudent use guidance.
Danish: På baggrund af rapportørernes vurdering af de tilgængelige data vedtog CVMP den 11. november 2009 en udtalelse, hvori det anbefalede ændring af markedsføringstilladelserne for lægemidler indeholdende (fluoro)quinoloner beregnet til brug hos arter bestemt til levnedsmiddelproduktion, for at ændre produktresuméet og indlægssedlen i de tilfælde, hvor disse ikke var i overensstemmelse med de advarsler og forsigtighedsregler vedrørende brugen, der anbefales i henhold til CVMP's debatoplæg "Reflection paper on the use of fluoroquinolones in food-producing animals - Precautions for use in the SPC regarding prudent use guidance."
English: Opinion following an Article 35F F referral for all veterinary medicinal products containing quinolones including fluoroquinolones intended for use in food-producing species
Danish: Udtalelse efter en indbringelse i henhold til artikel 35 vedrørende alle veterinærlægemidler indeholdende quinoloner, herunder fluoroquinoloner, beregnet til brug hos arter bestemt til levnedsmiddelproduktion
English: The other ingredients are:
Danish: De øvrige indholdsstoffer er:
English: Date of first authorisation: 03 October 2011 Date of latest renewal:08 September 2016
Danish: Dato for første markedsføringstilladelse: 3. oktober 2011 Dato for seneste fornyelse: 8. september 2016
English: A risk of birth defects for your unborn child cannot be completely excluded.
Danish: Risiko for medfødte misdannelser hos Deres ufødte barn kan ikke udelukkes helt.
English: In the elderly, the half-life is increased by about 40 % (10 to 11 hours).
Danish: Hos ældre er halveringstiden øget med ca. 40 % (10 til 11 timer).
English: Your doctor will establish the best possible treatment of overdose.
Danish: Deres læge vil fastlægge den bedst mulige behandling af overdosering.
English: Levetiracetam Actavis must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Danish: Levetiracetam Actavis skal tages to gange dagligt, én gang om morgenen og én gang om aftenen, på omtrent samme tidspunkt hver dag.
English: He/she may decide if your dose should be adjusted.
Danish: Han/hun kan beslutte om Deres dosis skal justeres.
English: Dose and frequency (1)
Danish: Dosis og hyppighed (1)
English: You should not stop your treatment without discussing this with your doctor.
Danish: De bør ikke standse med behandlingen uden aftale med Deres læge.
English: You may take Levetiracetam Actavis with or without food.
Danish: De kan tage Levetiracetam Actavis med eller uden mad.
English: Contact your doctor if you have missed one or more doses.
Danish: Kontakt lægen, hvis De har glemt en eller flere doser.
English: Read all of this leaflet carefully before you or your child start taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt inden De eller Deres barn begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: The requirements for submission of periodic safety update report for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Other unidentified components accounted only for 0.6 % of the dose.
Danish: Andre uidentificerede komponenter udgjorde kun 0,6 % af dosis.
English: Contact your doctor if you took more tablets than you should.
Danish: Kontakt lægen, hvis De har taget flere tabletter, end De burde.
English: The major metabolic pathway (24 % of the dose) is an enzymatic hydrolysis of the acetamide group.
Danish: Den vigtigste metaboliseringsvej (24 % af dosis) er enzymatisk hydrolyse af acetamid gruppen.
English: If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge til råds, før De tager dette lægemiddel.
English: 31-546 Kraków
Danish: 31-546 Krakow
English: • If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.
Danish: • Hvis De bemærker en stagnation i væksten eller uventet pubertetsudvikling hos Deres barn, så kontakt deres læge.
English: One was obtained by hydroxylation of the pyrrolidone ring (1.6 % of the dose) and the other one by opening of the pyrrolidone ring (0.9 % of the dose).
Danish: En blev opnået ved hydroxylering af pyrrolidonringen (1,6 % af dosis) og den anden ved åbning af pyrrolidonringen (0,9 % af dosis).
English: • as an add-on to other antiepileptic medicines to treat:
Danish: • som tillægsbehandling til andre antiepileptika til behandling af:
English: Therefore a 50 % reduction of the daily maintenance dose is recommended when the creatinine clearance is < 60 ml/min/1.73 m2.
Danish: Derfor anbefales en 50 % reduktion af daglig vedligeholdelsesdosis, når kreatininclearance er < 60 ml/min/1,73 m2.
English: You should not drive or use machines until it is established that your ability to perform such activities is not affected.
Danish: De må ikke køre eller anvende maskiner, før De er helt sikker på, at Deres evne til at udføre sådanne aktiviteter ikke er påvirket.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential.
Danish: De ikke-kliniske data viser ingen særlig fare for mennesker på basis af traditionelle undersøgelser af sikkerhedsfarmakologi, genotoksicitet og karcinogenicitet.
English: Do not use this medicine after the expiry date which is stated on the carton, label or blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken og blisterkortet efter ”EXP”.
English: Actavis treatment for as long as your doctor has told you.
Danish: Levetiracetam Actavis i så lang tid, som Deres læge har fortalt Dem.
English: Ks= 0.45 in Term infants to 1 year old; ks= 0.55 in Children to less than 13 years and in adolescent female; ks= 0.7 in adolescent male.
Danish: ks= 0,45 hos spædbørn op til 1 år; ks= 0,55 hos børn under 13 år og hos unge kvinder; ks= 0,7 hos unge drenge.
English: Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may result in a loss of its effect.
Danish: Tag ikke macrogol (et lægemiddel, som anvendes som afføringsmiddel) en time før og en time efter levetiracetam, da dette kan medføre tab af levetiracetams virkning.
English: Therefore, the interaction of Levetiracetam Actavis with other substances, or vice versa, is unlikely.
Danish: Derfor er interaktion mellem Levetiracetam Actavis og andre lægemidler eller vice versa ikke sandsynlig.
English: • if you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis De er allergisk over for levetiracetam, pyrrolidonderivater eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i pkt.
English: If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.
Danish: Hvis De har symptomer på depression og/eller selvmordstanker, så kontakt Deres læge.
English: Adverse reactions reported in clinical studies (adults, adolescents, children and infants >1 month) and from post-marketing experience are listed in the following table per System Organ Class and per frequency.
Danish: Bivirkninger rapporteret i kliniske undersøgelser (voksne, unge, børn og spædbørn >1 måned) og fra erfaring efter markedsføring vises i nedenstående tabel med organklasse og frekvens.
English: In addition it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and β-carbolines.
Danish: Desuden ophæver det delvist reduktionen i GABA-og glycin medierede strømme induceret af zink og βcarboliner.
English: • A small number of people being treated with anti-epileptics such as Levetiracetam Actavis have had thoughts of harming or killing themselves.
Danish: • En lille andel af de personer, der bliver behandlet med epilepsimedicin som for eksempel Levetiracetam Actavis, har haft selvmordstanker eller tanker om at skade sig selv.
English: See leaflet for further information.
Danish: Se indlædssedlen for yderligere information.
English: The film-coated tablets must be taken orally, swallowed with a sufficient quantity of liquid and may be taken with or without food.
Danish: De filmovertrukne tabletter skal indtages oralt, synkes med tilstrækkelig væske og kan tages sammen med eller uafhængigt af et måltid.
English: CLcr (ml/min) = ----------------------------------------- (x 0.85 for women) 72 x serum creatinine (mg/dl)
Danish: CLcr (ml/min) = ----------------------------------------- (x 0,85 for kvinder) 72 x serumkreatinin (mg/dl)
English: The apparent body weight adjusted clearance was approximately 30 % higher than in epileptic adults.
Danish: Den tilsyneladende vægtjusterede krops clearance var ca. 30 % højere end hos voksne med epilepsi.
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX14.
Danish: Farmakoterapeutisk klassifikation: antiepileptica, ATC-kode: NO3AX14.
English: Aluminium/PVC blister packs.
Danish: Aluminium/PVC blisterpakning.