FrancophonIA/ELRC3.0 huggingface dataset:
English: ANC=absolute neutrophil counts; CTCAE=Common Terminology Criteria for Adverse Events; LLN=lower limit of normal.
Danish: ANC = absolute neutrofiltal, CTCAE = Common Terminology Criteria for Adverse Events, LLN = nedre normalgrænse a. Skemaet gælder for alle hæmatologiske bivirkninger undtagen lymfopeni (medmindre de er forbundet med kliniske hændelser, som for eksempel opportunistiske infektioner) b. ANC: Grad 1: ANC < LLN - 1.500/mm
English: Coadministration of multiple 600 mg doses of rifampin with a single 125 mg palbociclib dose decreased palbociclib AUCinf and Cmax by 85% and 70%, respectively, relative to a single 125 mg palbociclib dose given alone.
Danish: Samtidig administration af flere doser rifampin 600 mg med en enkelt dosis palbociclib 125 mg reducerede den samlede eksponering (AUCinf) og peak-koncentration (Cmax) af palbociclib med henholdsvis 85 % og 70 % i forhold til en enkelt dosis palbociclib 125 mg givet alene.
English: Opaque, hard capsule, with a light orange body (printed “PBC 75” in white) and a light orange cap (printed “Pfizer” in white).
Danish: Uigennemsigtig hård kapsel med en lys orange underdel (mærket ”PBC 75” med hvid skrift) og en lys orange overdel (mærket ”Pfizer” med hvid skrift).
English: IBRANCE plus fulvestrant (N=141)
Danish: IBRANCE plus letrozol (N=141)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 100 MG CAPSULES
Danish: YDRE KARTON - 100 MG KAPSLER
English: No dose adjustments are required for moderate CYP3A inducers (see section 4.4).
Danish: Dosisjustering er ikke nødvendig ved administration samtidig med moderate CYP3A-induktorer (se pkt.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL - 100 MG CAPSULES
Danish: ETIKET TIL BEHOLDER - 100 MG KAPSLER
English: Red iron oxide (E172)
Danish: Rød jernoxid (E172) Gul jernoxid (E172) Titandioxid (E171)
English: NAME OF THE MEDICINAL PRODUCT IBRANCE 125 mg hard capsules palbociclib
Danish: IBRANCE 125 mg hårde kapsler palbociclib
English: Other side effects with IBRANCE may include: Very common side effects (may affect more than 1 in 10 people): Infections Reduction in white blood cells, red blood cells, and blood platelets Feeling of tiredness Decreased appetite Inflammation of the mouth and lips (stomatitis), nausea, vomiting, diarrhoea Rash Hair loss Weakness Fever Abnormalities in liver blood tests Dry skin Common side effects (may affect up to 1 in 10 people): Fever with a drop in the white blood cell count (febrile neutropenia) Blurred vision, increased tearing, dry eye Alteration in taste (dysgeusia) Nosebleed Reporting of side effects If you get any side effects, talk to your doctor, pharmacist, or nurse.
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer): Feber med nedsat antal hvide blodlegemer Sløret syn, øget tåreflåd, tørre øjne
English: NAME OF THE MEDICINAL PRODUCT IBRANCE 75 mg hard capsules palbociclib
Danish: IBRANCE 75 mg hårde kapsler palbociclib
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 125 MG CAPSULES
Danish: YDRE KARTON - 125 MG KAPSLER
English: Opaque, hard capsule, with a caramel body (printed “PBC 125” in white) and a caramel cap (printed “Pfizer” in white).
Danish: Uigennemsigtig hård kapsel med en karamelfarvet underdel (mærket ”PBC 125”med hvid skrift) og en karamelfarvet overdel (mærket ”Pfizer” med hvid skrift).
English: Table 7.
Danish: Skema 7.
English: Placebo plus fulvestrant (N=105)
Danish: Placebo plus letrozol (N=105)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL - 125 MG CAPSULES
Danish: ETIKET TIL BEHOLDER - 125 MG KAPSLER
English: Placebo plus fulvestrant (N=69)
Danish: Placebo plus letrozol (N=69)
English: Use of preparations containing St. John's Wort (see section 4.5).
Danish: Præparater, som indeholder perikon (se pkt.
English: Excretion of unchanged palbociclib in faeces and urine was 2% and 7% of the administered dose, respectively.
Danish: Henholdsvis 2 % og 7 % af den administrerede dosis blev genfundet som uomdannet palbociclib i fæces og urin.
English: A total of 666 postmenopausal women were randomised 2:1 to the palbociclib plus letrozole arm or placebo plus letrozole arm and were stratified by site of disease (visceral versus nonvisceral), disease-free interval from the end of (neo)adjuvant treatment to disease recurrence (de novo metastatic versus 12 months versus >12 months), and by the type of prior (neo)adjuvant anticancer therapies (prior hormonal therapy versus no prior hormonal therapy).
Danish: sygdomsplacering (visceral versus ikkevisceral), sygdomsfrit interval fra slutningen af (neo)-adjuverende behandling til sygdomsrecidiv (de novo metastatisk versus  12 måneder versus > 12 måneder), og iht.
English: Opaque, hard capsule, with a light orange body (printed “PBC 100” in white) and a caramel cap (printed “Pfizer” in white).
Danish: Uigennemsigtig hård kapsel med en lys orange underdel (mærket ”PBC 100” med hvid skrift) og en karamelfarvet overdel (mærket ”Pfizer” med hvid skrift).
English: MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG
Danish: Pfizer Europe MA EEIG (som logo)
English: Lacrimation increased
Danish: Nedsat nyrefunktion
English: Following oral administration of a single 125 mg dose of [14C]palbociclib to humans, the major primary metabolic pathways for palbociclib involved oxidation and sulphonation, with acylation and glucuronidation contributing as minor pathways.
Danish: C]palbociclib til mennesker blev palbociclib primært metaboliseret via oxidation og sulfatering medacylatering og glukuronidering som mindre væsentlige metaboliseringsveje.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL - 75 MG CAPSULES
Danish: ETIKET TIL BEHOLDER - 75 MG KAPSLER
English: In 6 healthy male subjects given a single oral dose of [14C]palbociclib, a median of 92% of the total administered radioactive dose was recovered in 15 days; faeces (74% of dose) was the major route of excretion, with 17% of the dose recovered in urine.
Danish: C] palbociclib, blev der mediant genfundet 92 % af den samlede administrerede radioaktive dosis efter 15 dage.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 75 MG CAPSULES
Danish: YDRE KARTON - 75 MG KAPSLER
English: Prior to the start of treatment with the combination of palbociclib plus fulvestrant, and throughout its duration, pre/perimenopausal women should be treated with LHRH agonists according to local clinical practice.
Danish: Præ-/perimenopausale kvinder skal behandles med en LHRH-agonist i henhold til lokal klinisk praksis inden start af behandling med kombinationen palbociclib plus fulvestrant og under hele behandlingen.
English: Progression-free survival (PFS) Number of events (%) Median [months (95% CI)] Hazard ratio (95% CI) and p-value
Danish: Median måneder (95 % CI) Hazard ratio (95 % CI) og p-værdi
English: Rashh Alopecia
Danish: Alopeci
English: The dose may be lowered to one of the other available strengths 100 mg or 75 mg. Take IBRANCE once a day at about the same time every day with food, preferably a meal.
Danish: Dosis kan nedsættes til en af de lavere tilgængelige styrker 100 mg eller 75 mg.
English: Table 6.
Danish: Skema 6.
English: h Rash includes the following PTs: Rash, Rash maculo-papular, Rash pruritic, Rash erythematous, Rash papular, Dermatitis, Dermatitis acneiform, Toxic skin eruption.
Danish: h. Udslæt omfatter følgende foretrukne termer: Pruritus, makulopapuløst udslæt, kløende udslæt,
English: Grade 4 n (%)
Danish: Grad 3 % Grad 4 % Alle grader
English: Posology
Danish: Dosisniveau
English: If you take more IBRANCE than you should
Danish: Hvis du har taget for meget IBRANCE
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 100 mg palbociclib.
Danish: Hver kapsel indeholder 100 mg palbociclib
English: intent-to-treat population) - PALOMA-2 study (31-May-2017)
Danish: Kaplan-Meier-kurver over progressionsfri overlevelse (investigators vurdering, intent-to-treat population) - PALOMA-2 studie (31. maj 2017)
English: System Organ Class Frequency Preferred Terma
Danish: Mave-tarm-kanalen Meget almindelig Stomatitis
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 75 mg palbociclib.
Danish: Hver kapsel indeholder 75 mg palbociclib.
English: EU/1/16/1147/007 (63 hard capsules)
Danish: EU/1/16/1147/001 (21 hårde kapsler) EU/1/16/1147/007 (63 hårde kapsler)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 125 mg palbociclib.
Danish: Hver kapsel indeholder 125 mg palbociclib
English: Netherlands, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Norway, Poland, Portugal and Spain.
Danish: Nederlandene, Østrig, Belgien, Danmark, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Luxembourg, Norge, Polen, Portugal og Spanien
English: The indication proposed cannot be accepted.
Danish: Den foreslåede indikation kan ikke accepteres.
English: - This was not a multicentric trial.
Danish: - Dette var ikke en multicenter-undersøgelse.
English: The test procedure did not follow the methods for a controlled or critical test.
Danish: Testproceduren fulgte ikke metoderne for en kontrolleret eller kritisk test.
English: Retreatment should be done according to the epidemiological situation, but not at less than 30 days interval
Danish: Genbehandling skal ske alt efter den epidemiologiske situation, men ikke med mindre end 30 dages interval
English: The youngest horse included in the field trial was 16 months old.
Danish: Den yngste hest i feltundersøgelsen var 16 måneder gammel.
English: ANNEX II SCIENTIFIC CONCLUSIONS
Danish: BILAG II VIDENSKABELIGE KONKLUSIONER
English: Applicant or Marketing Authorisation Holder
Danish: Ansøger eller indehaver af markedsføringstilladelsen
English: Efficacy should have been investigated at the lowest dose recommended.
Danish: Effekten skulle have været undersøgt ved den laveste anbefalede dosis.
English: - The number of horses recruited was too low to produce meaningful results.
Danish: - Det inkluderede antal heste var for lavt til at opnå meningsfulde resultater.
English: The results for efficacy of Eqvalan measured this way were also below 90%.
Danish: Resultaterne for effekten af Eqvalan, der blev målt på denne måde, var ligeledes under 90%.
English: A single field study was submitted in support of the efficacy of the product.
Danish: En enkelt feltundersøgelse blev indsendt til understøttelse af produktets effekt.
English: For Parascaris type eggs, the results were 50% by day 3 and 65.2% by day 8.
Danish: For æg af Parascaris-typen var resultaterne 50 % på dag 3 og 65,2 % på dag 8.
English: The wording of the proposal for Section 4.2 of the SPC is not supported.
Danish: Formuleringen af forslaget til afsnit 4.2 i produktresuméet understøttes ikke.
English: The WAAVP guidelines state that, for a field trial, data from at least 100 horses should be obtained in each of 3 different areas.
Danish: retningslinjerne fra WAAVP angiver, at der til en feltundersøgelse skal indhentes data fra mindst 100 heste inden for hvert af tre forskellige områder.
English: ANNEX III CONDITION FOR THE LIFTING OF THE SUSPENSION
Danish: BILAG III BETINGELSE FOR OPHÆVELSE AF SUSPENDERINGEN
English: Parascaris equorum should have been selected as the dose limiting parasite.
Danish: Parascaris equorum skulle have været valgt som den dosisbegrænsende parasit.
English: Therefore, if the product is administered at the recommended dose rate, there is the possibility of lack of efficacy and the potential for anthelmintic resistance.
Danish: Hvis produktet administreres i den anbefalede dosis, er der derfor mulighed for mangel på effekt og mulighed for anthelmintisk resistens.
English: This has not been shown, and in fact the indication is so restricted that the product could not be used for routine deworming in the horse.
Danish: Dette er ikke blevet påvist, og indikationen er faktisk så begrænset, at produktet ikke kan anvendes som rutinemæssig ormekur til heste.
English: Therefore the relevance of the bibliographical data regarding Eqvalan to the test product cannot be confirmed.
Danish: Relevansen af de bibliografiske data vedrørende Eqvalan for testproduktet kan derfor ikke bekræftes.
English: - The mean dose of test product administered was consistently and significantly more (40%, 0.278mg/kg) than the recommended treatment dose.
Danish: - Den gennemsnitlige dosis af det indgivne testprodukt var konsekvent og markant mere (40 %, 0,278 mg/kg) end den anbefalede behandlingsdosis.
English: The number of horses with an adequate infection pretreatment is impossible to determine as no negative control group was included.
Danish: Antallet af heste med en tilstrækkelig infektionsforbehandling er umulig at fastlægge, da ingen negativ kontrolgruppe deltog.
English: If it is assumed that the tables submitted in the response dossier refer to the results from the field study submitted in the original dossier, then these data are inadequate and therefore irrelevant due to the following reasons:
Danish: Hvis det antages, at de tabeller, der blev indsendt i responsdossiererne, henviser til resultaterne af den feltundersøgelse, der blev indsendt i de oprindelige akter, er disse data utilstrækkelige og derfor irrelevante af følgende årsager:
English: The relative egg reductions calculations do not reflect these findings, particularly regarding P. equorum.
Danish: Beregningerne af de relative fald i antal æg afspejler ikke disse fund, især for så vidt angår P. equorum.
English: - The dose-limiting parasite had not been specified or selected.
Danish: - Den dosisbegrænsende parasit var ikke nærmere angivet eller valgt.
English: - Although non-inferiority was demonstrated to Eqvalan, this is not a recognised measure of efficacy of a new product.
Danish: - Selvom noninferioritet blev påvist i forhold til Eqvalan, er dette ikke et anerkendt mål for effekten af et nyt produkt.
English: CONDITION FOR THE LIFTING OF THE SUSPENSION
Danish: BETINGELSE FOR OPHÆVELSE AF SUSPENDERINGEN
English: Relative reductions for the number of eggs per gram of faeces for the test product were calculated as 88.2% against Strongylus type eggs on day 3, and 88.2% at day 8.
Danish: De relative fald i antal æg pr. gram fæces for testproduktet blev beregnet til at være 88,2% i forhold til æg af Strongylus-typen på dag 3 og 88,2% på dag 8.
English: The results were not divided for each parasite species.
Danish: Resultaterne var ikke inddelt for hver parasitart.
English: Even the amended indication for the treatment of gastrointestinal endoparasitic infections in horses has not been demonstrated by the data provided.
Danish: Selv den ændrede indikation for behandlingen af gastrointestinale endoparasitiske infektioner hos heste er ikke blevet påvist med de indleverede data.
English: - The tables included in the response dossier do not indicate which parasites are referred to, and there is no break down of species of parasite.
Danish: - Tabellerne i responsdossiererne angiver ikke hvilke parasitter, der henvises til, og der er ingen opdeling af parasitarterne.
English: There is no reference in the Marketing Authorisation Holder's responses to the study that generated the results tables.
Danish: Der er ingen henvisning i responserne fra indehaveren af markedsføringstilladelsen til den undersøgelse, som lå til grund for resultattabellerne.
English: The current application cannot be considered satisfactory as there is no scientific basis on which to grant an authorisation with the proposed SPC.
Danish: Den aktuelle ansøgning kan ikke anses for at være fyldestgørende, da der ikke findes nogen videnskabelig baggrund for tildeling af en tilladelse med det foreslåede produktresumé.
English: Without necropsy or a large sample size, it is impossible to draw any meaningful conclusions from this study regarding the efficacy of Equimectin.
Danish: Uden nekropsi eller en større stikprøvestørrelse er det umuligt at drage nogen meningsfulde konklusioner af denne undersøgelse for så vidt angår effekten af Equimectin.
English: The bioequivalence with the originator product should be demonstrated by appropriate bioavailability study or adequate data should be provided with regard to residues and efficacy for this kind of application and the results of such study or such data should be submitted to the relevant national authority for further assessment.
Danish: Bioækvivalensen med det oprindelige produkt skal påvises med en passende biotilgængelighedsundersøgelse, eller fyldestgørende data vedrørende restmængder og effekt for denne type anvendelse skal indleveres, og resultaterne af en sådan undersøgelse eller sådanne data skal indsendes til de relevante nationale myndigheder med henblik på yderligere vurdering.
English: The statement ‘The treatment of gastrointestinal endoparasite infections in horses' implies that all gastrointestinal endoparasite infections in horses are treated with this product; ‘particularly' implies that the product has a specific action against those species listed.
Danish: Erklæringen ‘Behandlingen af gastrointestinale endoparasit-infektioner hos heste' antyder, at alle gastrointestinale endoparasit-infektioner hos heste behandles med dette produkt; ‘især' antyder, at produktet har en særlig virkemåde mod de angivne arter.
English: The dose of Eqvalan was found to be 10% higher in the field trial than indicated.
Danish: Det blev konstateret, at dosis af Eqvalan var 10 % højere i feltundersøgelsen end angivet.
English: Based on the following, interchangeability with other ivermectin containing products cannot be accepted:
Danish: På baggrund af følgende kan udskiftelighed med andre produkter, der indeholder ivermectin, ikke accepteres:
English: Therefore, this product would not be considered interchangable with other ivermectin containing products already on the market.
Danish: Dette middel vil derfor ikke blive anset for at kunne udskiftes med andre produkter, der indeholder ivermectin, og som allerede er på markedet.
English: ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
Danish: BILAG I LÆGEMIDLETS NAVN, LÆGEMIDDELFORM, STYRKE, DYREARTER, INDGIVELSESVEJE OG INDEHAVER AF MARKEDSFØRINGSTILLADELSEN
English: This does not comply with the recommendations of the current guidance document (CVMP/VICH/832/99), ‘where pharmacokinetic parameters cannot demonstrate a relationship with effectiveness, two dose confirmation studies using the dose limiting parasite for therapeutic claims ….. will be needed.'
Danish: Dette følger ikke anbefalingerne i det gældende vejledende dokument (CVMP/VICH/832/99) ‘I de tilfælde, hvor farmakokinetiske parametre ikke kan påvise et forhold med effekt, kræves der to dosisbekræftende undersøgelser med den dosisbegrænsende parasit for at understøtte behandlingens virkning.'
English: These results were below the accepted 90% or higher and, as there was no control group to compare the differences in parasite counts statistically, which should be significant at p<0.05, it is not possible to determine the efficacy of Equimectin from this study.
Danish: Disse resultater var under de accepterede 90 % eller derover, og da der ikke var nogen kontrolgruppe til statistisk sammenligning af forskellene i parasittal, som skulle være signifikant ved p<0,05, er det ikke muligt at fastlægge effekten af Equimectin med baggrund i denne undersøgelse.
English: Ivermectin containing pastes/oral gels for horses are well established on the market and the prescriber/animal owner would expect Equimectin to be interchangeable with other available products of the avermectin class.
Danish: Pasta/oral gel, der indeholder ivermectin, til heste er veletableret på markedet, og den ordinerende dyrlæge/dyrets ejer vil forvente, at Equimectin kan udskiftes med andre tilgængelige produkter i avermectin-klassen.
English: The Marketing Authorisation Holder reexamined the data from this study and stated that on day 6 after treatment no small nor large strongyle larvae were detected in a minimum amount of 25 gram faeces indicating 100% efficacy for all animals, and the recalculated effectiveness against Strongylides is >> 90% on 2 and 7 days after treatment.
Danish: Indehaveren af markedsføringstilladelsen gennemgik dataene fra denne undersøgelse på ny og angav, at der på dag 6 efter behandlingen ikke blev fundet hverken små eller store Strongylus-larver i en fæcesmængde på mindst 25 gram, hvilket tyder på en 100 % effekt for alle dyr, og den genberegnede effekt over for strongyloider er >> 90 % på 2. og 7. dag efter behandling.
English: The Committee, having considered the matter, concluded that on the basis of the available data for Equimectin bioequivalence with the reference product has not been shown.
Danish: Efter overvejelse af sagen konkluderede komitéen, at på baggrund af de tilgængelige data for Equimectins er bioækvivalens med referenceproduktet ikke påvist.
English: - Based on the type of study conducted, the background exposure of the ponies included in the trial was not stated therefore the adequacy of the infections cannot be documented.
Danish: - Baseret på den type undersøgelse, der blev gennemført, blev baggrundseksponeringen for ponyerne i undersøgelsen ikke angivet, og infektionernes tilstrækkelighed kan derfor ikke dokumenteres.
English: The documentation submitted with this application consists of literature referring to the use of the originator product Eqvalan, a comparative pharmacokinetic study using Equimectin and Eqvalan, and a supplementary clinical field study.
Danish: Dokumentationen, der er indsendt sammen med denne ansøgning, består af litteratur, som refererer til anvendelsen af det oprindelige produkt, Eqvalan, en komparativ farmakokinetisk undersøgelse med anvendelse af Equimectin og Eqvalan samt en supplerende klinisk feltundersøgelse.
English: It is not practical for an SPC for an equine wormer to only indicate use of the product against 5 specific parasites that do not include the important Strongylus genus in horses, but to imply that the product has efficacy against a wider population of parasites.
Danish: Det er ikke praktisk, at et produktresumé for et ormemiddel til heste kun angiver anvendelse af midlet mod fem bestemte parasitter, som ikke omfatter den vigtige Strongylus-slægt hos heste, som midlet kan anvendes mod, men antyder, at midlet har en virkning mod en bredere population af parasitter.
English: - The principle criteria used for a comparison of effect is egg count reduction/larval identification or parasite counts in dose confirmation studies.
Danish: - Det vigtigste kriterium, der er anvendt til en sammenligning af effekten, er reduktionen i antal æg/larveidentifikation eller antal parasitter i undersøgelser til kontrol af dosis.
English: A single administration of 0.2 mg ivermectin per kg of bodyweight.
Danish: En enkelt indgift af 0,2 mg ivermectin pr. kg legemsvægt.
English: The effect against e.g. the large strongyles that are important parasites in the horse is not supported by the presented data and moreover, as the effect on the L4 stage of the small strongyles is not substantiated, the period between necessary prophylactic deworming will be significantly shortened.
Danish: Virkningen mod fx de store strongyloider, som er fremtrædende parasitter hos heste, understøttes ikke af de fremlagte data, og desuden vil perioden mellem de nødvendige profylaktiske ormekure blive betydeligt afkortet, da effekten på de små strongyloiders L4-stadium ikke er underbygget.
English: - The test product demonstrated lower bioavailability compared to Eqvalan, the cited reference product, during the bioequivalence study, and the test product was administered at greater than the recommended treatment dose in the field study.
Danish: - Testproduktet viste lavere biotilgængelighed sammenlignet med Eqvalan det anførte referenceprodukt, i undersøgelsen af bioækvivalens, og testproduktet blev i feltundersøgelsen indgivet i doser, der var større end den anbefalede behandlingsdosis.
English: Based on the critical test performed, the efficacy against Parascaris was 100%.
Danish: Effekten over for Parascaris var på baggrund af den gennemførte kritiske test 100 %.