FrancophonIA/ELRC3.0 huggingface dataset:
English: cobicistat, telaprevir, lopinavir, itraconazole, voriconazole, clarithromycin, telithromycin, posaconazole, nefazodone and grapefruit juice.
Danish: Potente CYP3A-hæmmere inkluderer, men er ikke begrænset til, ritonavir, cobicistat, telaprevir, lopinavir, itraconazol, voriconazol, clarithromycin, telithromycin,
English: Vemurafenib dosing can be continued when Cotellic treatment is interrupted, if clinically indicated.
Danish: Hvis det er klinisk indiceret, kan vemurafenib-dosering fortsættes, mens Cotellic-behandlingen afbrydes.
English: Rhabdomyolysis***
Danish: Rabdomyolyse***
English: No dose adjustment is recommended in patients with mild or moderate renal impairment based on population pharmacokinetic analysis (see section 5.2).
Danish: Baseret på farmakokinetiske populationsanalyser er dosisjustering ikke nødvendig til patienter med let til moderat nedsat nyrefunktion (se pkt.
English: Primary Endpoint a, f
Danish: Primært endepunktaf
English: If you take more Cotellic than you should
Danish: Hvis du har taget for meget Cotellic
English: Before taking Cotellic in combination with vemurafenib, patients must have BRAF V600 mutationpositive tumour status confirmed by a validated test.
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Før anvendelse af Cotellic i kombination med vemurafenib skal det bekræftes ved en valideret test, at patienten tumorstatus er BRAF-V600-mutationspositiv.
English: · If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet.
English: Cutaneous squamous cell carcinoma has been reported with a lower frequency in the Cotellic plus vemurafenib arm vs placebo plus vemurafenib arm (all Grade: 3% vs 13%).
Danish: Der blev indberettet færre tilfælde af kutant pladecellekarcinom i Cotellic-plus-vemurafenib-armen end i placebo-plus-vemurafenib-armen (alle grader: 3% versus 13%).
English: (or 40-49% and < 10% absolute decrease from baseline)
Danish: (eller og < 10% absolut fald fra baseline)
English: If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Danish: Kontakt lægen, inden du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse former for sukker.
English: If CPK elevations do not improve to Grade ≤3 within 4 weeks following dose interruption, Cotellic treatment should be permanently discontinued.
Danish: Cotellic-behandling skal seponeres permanent hvis ikke stigninger i kreatinkinase forbedres til grad ≤ 3 inden for 4 uger efter dosis afbrydelse.
English: The safety of Cotellic in combination with vemurafenib has been evaluated in 247 patients with advanced BRAF V600 mutated melanoma in Study GO28141.The median time to onset for the first Grade ≥3 adverse events was 0.6 months in the Cotellic plus vemurafenib arm vs 0.8 months in the placebo plus vemurafenib arm.
Danish: Mediantiden til debut af de første grad ≥ 3 bivirkninger var 0,6 måned i Cotellic-plus-vemurafenib-armen versus 0,8 måned i placebo-plusvemurafenib-armen.
English: Tablet core
Danish: Sekundære nøgle-endepunkteraf
English: Visual disturbances have been reported in some patients treated with cobimetinib during clinical trials (see sections 4.4 and 4.8).
Danish: I kliniske studier er der rapporteret synsforstyrrelser hos patienter behandlet med cobimetinib (se pkt.
English: INFORMATION IN BRAILLE
Danish: INFORMATION I BRAILLESKRIFT cotellic
English: Dose adjustment is not recommended for mild to moderate renal impairment based on the results of the population pharmacokinetic analysis.
Danish: Baseret på farmakokinetiske populationsanalyser er dosisjustering ikke nødvendig hos patienter med let til moderat nedsat nyrefunktion.
English: Vemurafenib treatment can be continued when Cotellic treatment is modified, if clinically indicated.
Danish: Hvis det er klinisk indiceret, kan behandlingen med vemurafenib fortsætte, mens behandlingen med Cotellic ændres.
English: Rhabdomyolysis has been reported in patients receiving Cotellic (see section 4.8).
Danish: Der er rapporteret rabdomyolyse hos patienter, der får Cotellic (se pkt.
English: Photosensitivityb, Rash, Rash maculo-papular, Dermatitis acneiform, Hyperkeratosis**
Danish: Hud og subkutane væv Lysoverfølsomhedb, udslæt, makulopapuløst udslæt, akneiform dermatitis, hyperkeratose**
English: c
Danish: f
English: No pharmacokinetic trial in subjects with renal impairment has been conducted.
Danish: Der er ikke gennemført farmakokinetiske studier med patienter med nedsat nyrefunktion.
English: LVEF value
Danish: LVEF
English: It is important to keep taking Cotellic for as long as your doctor prescribes it.
Danish: Det er vigtigt, at du bliver ved med at tage Cotellic lige så længe, lægen har ordineret det. Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er noget, du er i tvivl om.
English: The areas harmonised include:
Danish: De harmoniserede områder omfatter følgende:
English: EMA/319080/2013 Rev.1 EMEA/H/A-30/1301
Danish: Den 12. september 2013 EMA/319080/2013 Rev.1 EMEA/H/A-30/1301
English: The European Commission issued a decision on 12 September 2013.
Danish: Europa-Kommissionen traf en afgørelse den 12. september 2013.
English: Targocid is authorised in the EU via national procedures.
Danish: Targocid blev godkendt i EU via nationale procedurer.
English: What is Targocid?
Danish: Hvad er Targocid?
English: The company that markets these medicines is Sanofi-Aventis.
Danish: Den virksomhed, der markedsfører disse lægemidler, er Sanofi-Aventis.
English: The amount of the medicine in the blood should be measured to ensure that effective levels have been reached.
Danish: Lægemidlets koncentration i blodet bør måles for at sikre, at der er opnået et effektivt niveau.
English: Why was Targocid reviewed?
Danish: Hvorfor blev Targocid vurderet igen?
English: On 30 May 2013, the European Medicines Agency completed a review of Targocid.
Danish: Den 30. maj 2013 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Targocid.
English: Targocid is also available in the EU under other trade names: Targosid, Teicomid.
Danish: Targocid fås desuden i EU under andre handelsnavne: Targosid, Teicomid.
English: The Committee did not recommend the use of Targocid to prevent infections.
Danish: Udvalget anbefalede ikke anvendelse af Targocid til forebyggelse af infektioner.
English: The Committee also agreed on specific dose ranges for adults and children (from birth) for the various infections.
Danish: Udvalget fastlagde desuden dosisområder for voksne og børn (fra fødslen) for de forskellige infektioner.
English: Targocid is an antibiotic that contains the active substance teicoplanin.
Danish: Targocid er et antibiotikum, der indeholder det aktive stof teicoplanin.
English: Targocid should be used to treat severe infections where standard antibiotic treatment is not suitable.
Danish: Targocid bør anvendes til behandling af alvorlige infektioner, hvor sædvanlig antibiotisk behandling ikke er hensigtsmæssig.
English: The Committee also harmonised other sections of the SmPC, including sections 4.3 (contraindications), 4.5 (interactions with other medicines), 4.6 (use in pregnancy and breast feeding), 4.8 (undesirable effects), 5.1 (pharmacodynamic properties), 5.2 (pharmacokinetic properties) and 5.3 (preclinical safety data).
Danish: CHMP harmoniserede desuden andre afsnit af produktresuméet, herunder afsnit 4.3 (kontraindikationer), 4.5 (interaktion med andre lægemidler), 4.6 (anvendelse under graviditet og amning), 4.8 (bivirkninger), 5.1 (farmakodynamiske egenskaber), 5.2 (farmakokinetiske egenskaber) og 5.3 (prækliniske sikkerhedsdata).
English: The active substance, teicoplanin, is one of a group of antibiotics known as glycopeptides.
Danish: Det aktive stof, teicoplanin, tilhører en gruppe antibiotika, der kaldes glykopeptider.
English: The CHMP agreed that Targocid should be used by injection or infusion to treat the following infections in adults and children:
Danish: CHMP vedtog, at Targocid bør anvendes ved injektion eller infusion til behandling af følgende infektioner hos voksne og børn:
English: Prolonged use may encourage the growth of bacteria against which it is not active.
Danish: Langvarig brug kan medføre vækst af bakterier, som det ikke virker mod.
English: On 17 November 2011, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Targocid in the EU.
Danish: Den 17. november 2011 indbragte Europa-Kommissionen sagen for CHMP med henblik på at harmonisere markedsføringstilladelserne for Targocid i EU.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Danish: Dette har ført til afvigelser mellem medlemsstaterne i den måde, lægemidlet kan anvendes på, således som det fremgår af forskellene i produktresuméer, etikettering og indlægssedler i de lande, hvor lægemidlet markedsføres.
English: The Committee asked the company that markets the medicine to submit a risk management plan for the safe use of Targocid, including a study to monitor the safety of the increased initial dose recommendations (12 mg per kg body-weight twice daily).
Danish: Udvalget anmodede den virksomhed, der markedsfører lægemidlet, om at indsende en risikostyringsplan for sikker anvendelse af Targocid, herunder en undersøgelse til overvågning af sikkerheden af den øgede anbefalede startdosis (12 mg/kg kropsvægt to gange dagligt).
English: • bacteraemia (bacterial infection in the blood) resulting from any of the above.
Danish: • bakteriæmi (bakterieinfektion i blodet) forårsaget af en af ovennævnte tilstande.
English: This includes initial doses as well as doses for maintenance treatment and doses to be used in patients with reduced kidney function.
Danish: Dette omfattede start- og vedligeholdelsesdoser samt doser til patienter med nedsat nyrefunktion.
English: It works by attaching to the surface of bacteria.
Danish: Det virker ved at binde sig til bakteriernes overflade.
English: Since Targocid is only effective against certain kinds of bacteria, it should be used in combination with other antibiotics if necessary, and in line with official recommendations on antibiotic use.
Danish: Da Targocid kun er effektivt mod visse bakteriearter, bør det om nødvendigt anvendes i kombination med andre antibiotika og i henhold til officielle anbefalinger for anvendelse af antibiotika.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Targocid in the European Union (EU).
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for harmonisering af produktinformationen for Targocid i Den Europæiske Union (EU).
English: • endocarditis (infection of the inner lining of the heart - most commonly the valves of the heart);
Danish: • endokarditis (infektion af hjertets indervæg - oftest hjerteklapperne)
English: It is only effective against certain types of bacteria (called Gram-positive bacteria) and should be used in combination with other antibiotics if necessary.
Danish: Det er kun effektivt mod bestemte typer bakterier (grampositive bakterier) og bør om nødvendigt anvendes i kombination med andre antibiotika.
English: It is used by injection or infusion (drip) to treat serious bacterial infections.
Danish: Det anvendes til injektion eller infusion (med drop) til behandling af alvorlige bakterielle infektioner.
English: Patients should be particularly carefully monitored if given higher initial doses (12 mg per kg body-weight twice daily).
Danish: Særlig omhyggelig overvågning kræves, hvis patienten får højere startdosis (12 mg/kg kropsvægt to gange dagligt).
English: For certain types of infections, a higher initial dose of 12 mg per kg body-weight twice daily (used in a few member states of the EU), was agreed by the CHMP.
Danish: For visse typer infektioner fastlagde CHMP en højere begyndelsesdosis på 12 mg/kg kropsvægt to gange dagligt (som anvendes i enkelte medlemsstater i EU).
English: Other possible effects for which treatment may need to be stopped or altered include infusion-related reactions called ‘red man syndrome', severe skin rashes, thrombocytopenia (low blood-levels of cells called platelets that are important for clotting), kidney damage, and effects on hearing.
Danish: Andre mulige effekter, der kan gøre det nødvendigt at stoppe eller ændre behandlingen, er infusionsrelaterede reaktioner (såkaldt “red man syndrome” alvorligt hududslæt, trombocytopeni (lavt indhold i blodet af blodplader, som er vigtige for blodets evne til at størkne), nyrebeskadigelse og påvirkning af hørelsen.
English: Regular blood and kidney function tests and monitoring of any effects on hearing are recommended during treatment.
Danish: Under behandlingen anbefales regelmæssig kontrol af blodet og nyrefunktionen samt overvågning af eventuel påvirkning af hørelsen.
English: • hospital- or community-acquired pneumonia (infection of the lung caught in or outside hospital);
Danish: • lungebetændelse, der er hospitals- eller samfundserhvervet (erhvervet på eller uden for hospitalet).
English: These include the fact that Targocid may cause serious life-threatening hypersensitivity (allergic) reactions which require immediate cessation of the medicine and emergency treatment; care is needed in patients who are allergic to another antibiotic, vancomycin, as they may be at greater risk.
Danish: Hertil hører, at Targocid kan forårsage alvorlige livstruende allergiske reaktioner (hypersensitivitetsreaktioner), som kræver øjeblikkeligt ophør af behandling og akut behandling med lægemidlet; ved allergi over for et andet antibiotikum, vancomycin.
English: • complicated infections of the skin and soft-tissues;
Danish: • komplicerede infektioner i hud og underliggende væv
English: Targocid was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Danish: Koordinationsgruppen Vedrørende Gensidig Anerkendelse og Decentraliserede Godkendelsesprocedurer - human (CMD(h)) fandt harmonisering for Targocid nødvendig.
English: The Committee also agreed that Targocid could be taken by mouth to treat diarrhoea and colitis (inflammation of the bowel) associated with infection by bacteria called Clostridium difficile.
Danish: Udvalget fandt desuden, at Targocid kunne gives gennem munden til behandling af diarré og inflammation af tarmen (colitis) forårsaget af infektion med bakterien Clostridum difficile.
English: It can also be given by mouth to treat diarrhoea and colitis (inflammation of the bowel) caused by infection with a bacterium called Clostridum difficile.
Danish: Det kan desuden gives gennem munden til behandling af diarré og inflammation af tarmen (colitis) forårsaget af bakterien Clostridum difficile.
English: • bone and joint infections;
Danish: • infektioner i knogler og led
English: • peritonitis (inflammation of the peritoneum, the membrane lining the abdominal cavity) in patients undergoing ‘continuous ambulatory peritoneal dialysis';
Danish: • peritonitis (inflammation af peritoneum, dvs. den membran, der beklæder bughulen indvendigt)
English: The CHMP agreed to harmonise the warnings and precautions for the medicine.
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen CHMP vedtog at harmonisere advarsler og forsigtighedsregler for lægemidlet.
English: • complicated urinary tract infections (infections of the structures that carry urine);
Danish: • komplicerede urinvejsinfektioner
English: EMA Number
Danish: EMA nummer
English: The procedure was therefore referred to the CHMP in October 2008.
Danish: Proceduren blev derfor henvist til CHMP i oktober 2008.
English: It has been marketed since 1979, for intramuscular use.
Danish: Det har været markedsført siden 1979 til intramuskulær anvendelse.
English: Summary of the report from the BPWP and CHMP position:
Danish: Sammendrag af rapporten fra BPWP og CHMP's holdning:
English: The Applicant also provided exposure data, stating that a total of about 143,589 injections were given to patients.
Danish: Ansøgeren forelagde endvidere eksponeringsdata, hvoraf det fremgik, at der i alt var givet ca. 143.589 injektioner til patienter.
English: And if yes, what kind of non-clinical studies shall be performed?
Danish: Hvilke ikkekliniske undersøgelser skal der i bekræftende fald foretages?
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF UMAN BIG
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF UMAN BIG
English: Therefore, the CHMP is of the opinion that the benefit/risk balance of the product can be considered to be positive and that the product is approvable.
Danish: CHMP er derfor af den mening, at benefit/risk-forholdet for produktet kan betragtes som positivt, og at produktet kan godkendes.
English: Levels of antibodies of ≥100IU/ml were achieved.
Danish: Der blev nået niveauer af antistoffer på ≥100IE/ml.
English: Limited cases of nausea, vomiting, hypotension, tachycardia, allergic or anaphylactic reactions have also been reported.
Danish: Der er også set et begrænset antal tilfælde af kvalme, opkastning, hypotension, takykardi og allergiske eller anafylaktiske reaktioner.
English: Although the Reference Member State concluded that the objections raised had been resolved, the Objecting Concerned Member State was still of the opinion that a potential serious risk to public health was identified for this particular product, with regards to safety and efficacy.
Danish: Selv om referencemedlemsstaten konkluderede, at indsigelserne var blevet afklaret, var den berørte medlemsstat, der havde gjort indsigelser, stadig af den opfattelse, at der var påvist en potentiel alvorlig risiko for folkesundheden ved dette specifikke produkt for så vidt angår sikkerhed og effekt.
English: Specific neutralizing antibodies against the Hepatitis B virus are present at a concentration of not less than 180 IU/ml.
Danish: Specifikke neutraliserende antistoffer imod hepatitis B-virus forekommer ved en koncentration på ikke mindre end 180 IE/ml.
English: The Applicant provided a summary of the available post-marketing experience data for both UMAN BIG and IMMUNOHBs (a different brand name an identical product with the same pack sizes and concentration, produced by the same manufacturing sites, using the same manufacturing process), indicating that approximately 143,381,160 IU of IMMUNOHBs and approximately 11,695,680 IU of UMAN BIG have been sold worldwide between June 1995 and December 2007.
Danish: Ansøgeren forelagde et sammendrag af de tilgængelige data vedrørende erfaringer efter markedsføring for både UMAN BIG og IMMUNOHBs (et andet varemærke for et identisk produkt med samme pakningsstørrelser og koncentration, fremstillet af samme fremstillingsvirksomheder via den samme fremstillingsproces), hvoraf det fremgik, at der på verdensplan er solgt ca. 143.381.160 IE IMMUNOHBs og ca. 11.695.680 IE UMAN BIG mellem juni 1995 og december 2007.
English: The Applicant stated that the only relevant measure of efficacy for this kind of product is the level of protective anti-HBs achieved in the plasma, since after the introduction of vaccination it is no longer feasible to assess the efficacy of the product on the basis of the incidence of new infections.
Danish: Ansøgeren har angivet, at det eneste relevante effektmål for denne type produkt er niveauet af beskyttende anti-HBs i plasmaet, da det efter indførelsen af vaccine ikke længere er muligt at vurdere produktets effekt på baggrund af forekomsten af nye infektioner.
English: According to the Applicant, the characteristics of the product, the available safety data, and the overall safety system in place do not warrant any recommendations for further risk minimisation activities.
Danish: Ifølge ansøgeren taler produktets egenskaber, de tilgængelige sikkerhedsdata og det overordnede sikkerhedssystem ikke for en anbefaling om yderligere risikominimeringsaktiviteter.
English: Content (concentration)
Danish: Styrke LægemiddelformIndgivelsesvej Indhold (Koncentration)
English: Should non-clinical product-specific safety data be submitted for this product, in line with point 5.3 the Core SPC for human Immunoglobulin for IV administration?
Danish: Bør der indgives ikkekliniske produktspecifikke sikkerhedsoplysninger for dette produkt, i overensstemmelse med punkt 5.3 i det grundlæggende produktresumé for human immunoglobulin til intravenøs administration?
English: GROUNDS FOR OPINION
Danish: BEGRUNDELSE FOR UDTALELSEN
English: The CHMP fully endorses the development of a combined Guideline on specific immunoglobulins, in order to harmonise the requirements for granting marketing authorization.
Danish: CHMP giver sin fulde støtte til udarbejdelsen af en kombineret vejledning vedrørende specifikke immunoglobuliner med henblik på at harmonisere kravene for udstedelse af markedsføringstilladelse.
English: UMAN BIG contains glycine as the excipient, a natural amino acid and therefore not expected to cause any problems.
Danish: UMAN BIG indeholder hjælpestoffet glycin, som er en naturlig aminosyre og derfor ikke forventes at forårsage nogen problemer.
English: UMAN BIG belongs to the pharmacological class of immune sera and human specific immunoglobulins for intramuscular administration and contains 100-180 g/l of plasma proteins with at least 90% of them representing Immunoglobulin G (IgG).
Danish: UMAN BIG tilhører den farmakologiske klasse for immunsera og humanspecifikke immunoglobuliner til intramuskulær administration og indeholder 100-180 g/l plasmaproteiner, hvoraf mindst 90 % repræsenterer immunoglobulin G (IgG).
English: The dose regimen and protective threshold were consistent with the current core SPC.
Danish: Dosisregimet og beskyttelsestærsklen var i overensstemmelse med det aktuelle grundlæggende produktresumé.
English: The Applicant concluded that no new information on tolerability is available to suggest a modification of the safety profile of UMAN BIG.
Danish: Ansøgeren konkluderede, at der ikke er nogen nye oplysninger om tolerabilitet, der giver anledning til en ændring af sikkerhedsprofilen for UMAN BIG.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATE
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: The Applicant also demonstrated the impossibility to perform any clinical study in any of the populations included in the indication, apart from newborns, after the introduction of the vaccination.
Danish: Ansøgeren påviste også, at det var umuligt at gennemføre kliniske undersøgelser i nogen af de i indikationen angivne populationer, med undtagelse af nyfødte, efter indførelsen af vaccinen.
English: More than 1,000 Italian newborns included in the studies (published between 1983 and 2001) received UMAN BIG and the dose regimen and protective threshold (10 mIU/ml) are consistent with the provisions of the current core SPC and proposed SPC.
Danish: Over 1.000 nyfødte italienske børn, der var en del af undersøgelsen (publiceret mellem 1983 og 2001), modtog UMAN BIG, og dosisregimet og beskyttelsestærsklen (10 mIE/ml) var i overensstemmelse med bestemmelserne i det aktuelle grundlæggende produktresumé og forslåede produktresumé.
English: In conclusion, the CHMP sought advice from the Blood Products Working Party on the four questions raised for discussion and noted the positive recommendation in favour of UMAN BIG expressed by the BPWP in a report dated 27 November 2008.
Danish: CHMP søgte således rådgivning hos BPWP angående de fire spørgsmål, der var til diskussion, og bemærkede den positive anbefaling til fordel for UMAN BIG i en rapport fra BPWP af 27. november 2008.