natgillin/translations-raw huggingface dataset:
Punkt 4.3 Kontraindikationer
Section 4.3 Contraindications
I en klinisk pivotalundersøgelse blev virkningen ikke påvist, og sikkerheden ikke klarlagt (se pkt.
In the pivotal clinical trial, efficacy was not demonstrated and safety was not established (see section 5.1).
Der er udført kliniske undersøgelser med forskellige doser af Arimidex, op til 60 mg i en enkelt dosis til raske frivillige mandlige forsøgspersoner og op til 10 mg dagligt til postmenopausale kvinder med fremskreden brystcancer.
Clinical trials have been conducted with various dosages of Arimidex, up to 60 mg in a single dose given to healthy male volunteers and up to 10 mg daily given to postmenopausal women with advanced breast cancer; these dosages were well tolerated.
CHMP noterede sig forslaget fra indehaveren af markedsføringstilladelsen og bad om en revision af ordlyden vedrørende farmakokinetikken på den pædiatriske population for at tydeliggøre de præcise karakteristika ved den undersøgte population og dens potentielle indvirkning på resultaterne.
The CHMP noted the proposal from the MAH and asked for a revision of the wording on the pharmacokinetics on the paediatric population, to clarify the exact characteristics of the population studied and its potential impact on the results obtained.
En anbefalet behandlingsvarighed på 5 år er berettiget af resultaterne af ATAC-undersøgelsen, hvor virkningen af adjuverende behandling med Arimidex blev sammenlignet med adjuverende behandling med tamoxifen.
A recommended duration of treatment of 5 years is justified by the results of the ATAC study, in which the efficacy of adjuvant treatment with Arimidex was compared to adjuvant treatment with tamoxifen.
Aromatasehæmmere har påvist virkning hos østrogenreceptorpositive patienter og har vist sig at have ringe virkning på hormonreceptornegative patienter, hvilket er at forvente på baggrund af virkningsmekanismen.
Aromatase inhibitors have demonstrated efficacy in estrogen receptor positive patients, and has shown to have little efficacy in hormone receptor negative patients as could be anticipated by the mechanism of action.
Arimidex anbefales ikke til børn og unge pga. manglende dokumentation for sikkerhed og virkning i denne patientgruppe (se pkt.
Arimidex is not recommended for use in children and adolescents as safety and efficacy have not been established in this group of patients (see section 5.1).
Den endelige vedtagne ordlyd vedrørende anvendelse hos patienter med nedsat nyre- og leverfunktion er som følger:
The final adopted wording on use in renal and hepatic impairment is as follows:
• gravide eller ammende kvinder
• Pregnant or breast-feeding women.
Derfor blev den foreslåede advarsel vedrørende nedsat nyrefunktion ændret på anmodning fra CHMP, så den afspejler, at eksponeringen for anastrozol ikke forøges hos patienter med svært nedsat nyrefunktion, men at der alligevel skal udvises forsigtighed med administration af lægemidlet hos disse patienter.
Therefore the proposed warning on renal impairment was revised, at the request of the CHMP, to reflect that exposure to anastrozole is not increased in patients with severe renal impairment, but still in these patients administration should be performed with caution.
For at kunne harmonisere produktresuméerne blev følgende terapeutiske indikationer vedtaget:
In order to harmonise the SPCs for Arimidex, the following therapeutic indications were agreed upon:
De enzymer, som medierer metabolisering af anastrozol, er ikke identificeret.
The enzymes mediating metabolism of anastrozole have not been identified.
Der foreligger ingen data, som understøtter anvendelse af Arimidex med LHRH-analoger.
There are no data to support the use of Arimidex with LHRH analogues.
4.8 foreslog indehaveren af markedsføringstilladelsen at rette betegnelserne for organklasser ind efter MedDRA-terminologien, herunder grupperinger af hyppigheder, harmonisering af flere bivirkningshyppigheder, som var forskellige i medlemsstaterne, og opdatering af hyppigheden af bivirkninger som Stevens-Johnsons syndrom og angioødem fra "ikke kendt" til "meget sjælden" på baggrund af data fra ATAC-undersøgelsens 5-års-analyse.
In section 4.8, the MAH proposed to align the System Organ Class terms with the MedDRA dictionary, including the frequency groupings, harmonising several adverse reaction frequencies that varied between Member States, and updating the frequency of events such as Stevens-Johnson syndrome and angioedema from ‘not known' to ‘very rare', based on data from the ATAC study 5year analysis.
Der blev vedtaget harmoniserede udgaver af etikettering og indlægsseddel.
Harmonised versions of the labelling and of the package leaflet were adopted.
I undersøgelsen 1033IL/0014 var den tilsyneladende clearance (CL/F) af anastrozol efter oral administration omkring 30 % lavere hos frivillige med stabil levercirrhose, selvom plasmakoncentrationerne af anastrozol hos frivillige med levercirrhose lå inden for de koncentrationer, som ses hos normale forsøgspersoner i andre undersøgelser.
In study 1033IL/0014, the apparent clearance (CL/F) of anastrozole, following oral administration, was approximately 30% lower in volunteers with stable hepatic cirrhosis, although plasma anastrozole concentrations in the volunteers with hepatic cirrhosis were within the range of concentrations seen in normal subjects in other trials.
Anvendelse af specifikke behandlinger, f.eks. bisfosfonater, kan forhindre yderligere tab af knoglemineral, som skyldes Arimidex, hos postmenopausale kvinder og kan overvejes (se pkt.
The use of specific treatments, e.g., bisphosphonates, may stop further bone mineral loss caused by Arimidex in postmenopausal women and could be considered (see section 4.8).
Kvalitetsafsnittene i ansøgningen om markedsføringstilladelse til Arimidex-tabletter er harmoniseret og opdateret fra formatet "Vejledning til ansøgere" til "Fælles teknisk dokument".
The Quality Modules of Arimidex Tablet Marketing Authorisation Application have been harmonised and updated from Notice to Applicant (NTA) format to Common Technical Document (CTD) format.
Indehaveren af markedsføringstilladelsen foreslog desuden, at man medtog et resumé af de pædiatriske undersøgelser af gynækomasti og McCuneAlbrights syndrom, som allerede var godkendt i en række lande.
The MAH also proposed to include a summary of the paediatric studies on gynaecomastia and McCune-Albright syndrome, which had already been approved in a number of countries.
En gennemgang af den kliniske undersøgelsessikkerhedsdatabase viste ingen dokumentation for klinisk signifikant interaktion hos patienter, som blev behandlet med Arimidex, og som også fik andre almindeligt ordinerede lægemidler.
A review of the clinical trial safety database did not reveal evidence of clinically significant interaction in patients treated with Arimidex who also received other commonly prescribed medicinal products.
CHMP støttede forslaget fra indehaveren af markedsføringstilladelsen om ikke at inkludere denne advarsel i den harmoniserede ordlyd, da de publicerede kliniske undersøgelser ikke viser en signifikant stigning i total- eller LDL-kolesterol eller et fald i HDL-kolesterol efter anvendelse af Arimidex.
The CHMP supported the proposal from the MAH not to include this warning in the harmonised wording, as the published clinical studies do not indicate a significant increase in total cholesterol or LDL-C, or a decrease in HDL-C after Arimidex use.
Punkt 5.3 Prækliniske sikkerhedsdata
Section 5.3 Preclinical safety data
• patienter med kendt overfølsomhed over for anastrozol eller over for et eller flere af de hjælpestoffer, som er anført i pkt.
• Patients with known hypersensitivity to anastrozole or to any of the excipients as referenced in section 6.1.
Arimidex bør ikke anvendes til drenge med væksthormonmangel som tillæg til behandlingen med væksthormon.
Arimidex should not be used in boys with growth hormone deficiency in addition to growth hormone treatment.
Punkt 5.2 Farmakokinetiske egenskaber
Section 5.2 Pharmacokinetic properties
Da anastrozol nedsætter østradiolniveauerne, må Arimidex ikke anvendes til piger med væksthormonmangel som tillæg til behandlingen med væksthormon.
Since anastrozole reduces estradiol levels, Arimidex must not be used in girls with growth hormone deficiency in addition to growth hormone treatment.
Der er ingen data fra anvendelse af Arimidex til gravide kvinder.
There are no data from the use of Arimidex in pregnant women.
En henvisning til reduktion i forekomsten af kontralateral brystcancer ville ikke bidrage til patientpopulationen og skulle derfor kun inkluderes i pkt.
A reference to reduction in incidence of contra lateral breast cancer would not add to the patient population and should therefore be included only in section 5.1 of the SPC.
Fald i knogledensitet og Schönlein-Henochs purpura blev tilføjet som bivirkninger i pkt.
Bone density decrease and Henoch-Schönlein purpura were added to section 4.8 as adverse events.
Kliniske undersøgelser med antipyrin og warfarin viste, at anastrozol ved en dosis på 1 mg ikke signifikant hæmmer antipyrins samt R- og Swarfarins metabolisme, hvilket viser, at samtidig administration af Arimidex og andre lægemidler sandsynligvis ikke vil resultere i klinisk signifikante lægemiddelinteraktioner medieret af CYPenzymer.
Clinical studies with antipyrine and warfarin showed that anastrozole at a 1 mg dose did not significantly inhibit the metabolism of antipyrine and R- and S-warfarin indicating the co-administration of Arimidex with other medicinal products is unlikely to result in clinically significant medicinal product interactions mediated by CYP enzymes.
Den endelige vedtagne ordlyd af dette punkt er som følger:
The final adopted wording for this section is as follows:
I ét land indeholdt produktresuméet advarslen "der er observeret små stigninger i totalkolesterol hos patienter, som er behandlet med Arimidex.
In one country the SPC contained the warning ‘slight increases in total cholesterol have been observed in patients treated with Arimidex.
Ordlyden af dette punkt i produktresuméet var sammenlignelig i de fleste lande.
The wording for this section of the SPC was similar in most countries.
Videnskabelige konklusioner og begrundelser for ændring af produktresumé, etikettering og indlægsseddel fremlagt af EMA
Scientific conclusions and grounds for amendment of the summary of product characteristics, labelling and package leaflet presented by the European Medicines Agency
CHMP bemærkede den ordlyd, indehaveren af markedsføringstilladelsen foreslog til harmonisering af dette punkt, som indeholdt et udsagn om, at kliniske interaktionsundersøgelser af antipyridin og cimetidin viser, at signifikante lægemiddelinteraktioner medieret af cytochrom P450 er usandsynlige.
The CHMP noted the wording proposed by the MAH for the harmonisation of this section, which included a statement to the fact that antipyridine and cimetidine clinical interaction studies indicate that significant drug interactions mediated by cytochrome P450 are unlikely.
CHMP bemærkede forslaget fra indehaveren af markedsføringstilladelsen om at kontraindicere anvendelse under graviditet og amning, men mente, at der skulle henvises til manglende data hos mennesker og til reproduktionstoksicitet hos dyr.
The CHMP noted the proposal from the MAH to contraindicate use in pregnancy and lactation but considered that reference should be made to the lack of data in humans and a reference to reproductive toxicity in animals should be included.
Punkt 5.1 Farmakodynamiske egenskaber
Section 5.1 Pharmacodynamic properties
En foreslået sætning vedrørende SABRE-undersøgelsen nævnte Arimidex' neutrale virkning på plasmalipider hos patienter, der samtidig blev behandlet med risendronat.
One statement proposed in relation to the SABRE study mentioned a neutral effect of Arimidex on plasma lipids in patients concomitantly treated with risendronate.
CHMP vedtog følgende ordlyd for dette punkt:
The CHMP adopted the following wording for this section:
CHMP vedtog forslaget fra indehaveren af markedsføringstilladelsen med mindre ændringer.
The CHMP adopted the MAH's proposal with only minor amendments.
Da Arimidex sænker østrogenniveauerne i blodet, kan dette medføre en reduktion i knoglemineraldensiteten og en deraf følgende mulighed for øget frakturrisiko (se pkt.
As Arimidex lowers circulating estrogen levels it may cause a reduction in bone mineral density with a possible consequent increased risk of fracture (see section 4.8).
Arimidex er kontraindiceret under graviditet (se pkt.
Arimidex is contraindicated during pregnancy (see section 4.3).
Der var ingen væsentlige forskelle i ordlyden af dette punkt i de forskellige lande.
The wording for this section did not significantly differ between countries.
Der blev foreslået reviderede advarsler vedrørende nedsat nyre- og leverfunktion.
Revised warnings were suggested regarding renal and hepatic impairment.
Ændringerne i produktresuméet er også afspejlet i indlægssedlen, når det er relevant.
The changes to the SPC, when relevant, were also reflected in the package leaflet.
Punkt 4.8 Bivirkninger
Section 4.8 Undesirable effects
CHMP bemærkede den ordlyd, som indehaveren af markedsføringstilladelsen foreslog til dette punkt, og foreslog nogle få ændringer.
The CHMP noted the wording suggested by the MAH for this section and proposed a few revisions.
Indehaveren af markedsføringstilladelsen foreslog først følgende ordlyd: Behandling af fremskreden cancer mammae hos postmenopausale kvinder.
In its initial proposal the MAH suggested the following wording: Treatment of advanced breast cancer in postmenopausal women.
Etikettering og indlægsseddel
Labelling and Package Leaflet
CHMP bad derudover indehaveren af markedsføringstilladelsen om at inkludere oplysninger, som findes i produktresuméet i nogle lande, om forekomsten af karpaltunnelsyndrom i kliniske undersøgelser.
The CHMP further asked the MAH to include information present in the SPC of some countries on the occurrence of carpal tunnel syndrome in clinical trials.
CHMP anmodede om, at denne sætning blev slettet, da den modsiger inklusion af hyperkolesterolæmi som en bivirkning i pkt.
The CHMP requested for this statement to be deleted as it is contradictory with the inclusion of hypercholesterolaemia as a common adverse event in section 4.8.
Ændring af dosis anbefales ikke hos patienter med mildt eller moderat nedsat nyrefunktion.
No dose change is recommended in patients with mild or moderate renal impairment.
• Adjuverende behandling af tidlig invasiv hormonreceptorpositiv cancer mammae hos postmenopausale kvinder, som i 2-3 år har fået adjuverende behandling med tamoxifen.
• Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.
• Formålet med indbringelsen af sagen var at harmonisere produktresuméet, etiketteringen og indlægssedlen
• the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet
4.4, da der ifølge de nyeste undersøgelser ikke forventes en signifikant forøgelse af eksponeringen med nedsat nyrefunktion, og der kun blev observeret en beskeden øgning i eksponeringen hos patienter med nedsat leverfunktion.
Information on severe renal impairment and moderate or severe hepatic impairment was also moved to section 4.4, as based on the latest studies a significant increase in exposure is not expected with renal impairment, and only a modest increase in exposure was observed in patients with hepatic impairment.
Der foreligger ingen data om Arimidex under laktation.
There are no data on the use of Arimidex during lactation.
4.4 fra indehaveren af markedsføringstilladelsen og var enig i det meste af indholdet.
The CHMP noted the MAH's proposal for section 4.4 and agreed with the majority of the content.
Forsigtighed tilrådes hos patienter med moderat til svært nedsat leverfunktion (se pkt.
Caution is advised in patients with moderate to severe hepatic impairment (see section 4.4).
Ansøgeren skal sørge for overholdelse af den relevante monograf vedrørende anastrozol i Den Europæiske Farmakopé, som i øjeblikket er under revidering.
monograph of anastrozole which is currently under revision.
Begrundelser for ændring af produktresumé, etikettering og indlægsseddel
Grounds for amendment of the summary of product characteristics, labelling and package leaflet
• Behandling af fremskreden hormonreceptorpositiv cancer mammae hos postmenopausale kvinder.
• Treatment of hormone receptor-positive advanced breast cancer in postmenopausal women.
Samtidig administration af tamoxifen eller østrogenholdige behandlinger og Arimidex bør undgås, da dette kan mindske dets farmakologiske virkning (se pkt.
Co-administration of tamoxifen or estrogen-containing therapies with Arimidex should be avoided as this may diminish its pharmacological action (see section 4.5 and 5.1).
Arimidex er ikke undersøgt hos patienter med cancer mammae med moderat eller svært nedsat leverfunktion.
Arimidex has not been investigated in breast cancer patients with moderate or severe hepatic impairment.
• Produktresuméet, etiketteringen og indlægssedlen, som indehaveren af markedsføringstilladelsen foreslog, er blevet vurderet på baggrund af den fremsendte dokumentation og udvalgets videnskabelige drøftelse.
• the summary of products characteristics, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Arimidex.
• Adjuverende behandling af tidlig invasiv hormonreceptorpositiv cancer mammae hos postmenopausale kvinder.
• Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women.
Arimidex er ikke undersøgt hos patienter med cancer mammae med svært nedsat nyrefunktion.
Arimidex has not been investigated in breast cancer patients with severe renal impairment.
Punkt 4.2 Dosering og indgivelsesmåde
Section 4.2 Posology and method of administration
Arimidex er kontraindiceret under amning (se pkt.
Arimidex is contraindicated during breastfeeding (see section 4.3).
Virkning på knoglemineraldensitet
Effect on bone mineral density
CHMP bemærkede forslaget til pkt.
The CHMP noted the MAH's proposal for section 4.2.
CHMP godkendte følgende ordlyd, som indehaveren af markedsføringstilladelsen havde foreslået:
The CHMP agreed with the following wording proposed by the MAH:
Ændring af dosis anbefales ikke hos patienter med let nedsat leverfunktion.
No dose change is recommended in patients with mild hepatic disease.
CHMP noterede sig og var enig i forslaget til dette punkt fra indehaveren af markedsføringstilladelsen:
The CHMP noted and agreed with the MAH proposal for this section:
Den tilsyneladende clearance (CL/F) af anastrozol efter oral administration forblev uændret hos frivillige med svært nedsat nyrefunktion (GFR <30 ml/min.)
The apparent clearance (CL/F) of anastrozole, following oral administration, was not altered in volunteers with severe renal impairment (GFR <30ml/min) in study 1033IL/0018, consistent with the fact that anastrozole is eliminated primarily by metabolism.
Hos patienter med svært nedsat nyrefunktion bør Arimidex administreres med forsigtighed (se pkt.
In patients with severe renal impairment, administration of Arimidex should be performed with caution (see section 4.4 and 5.2).
Administration af Arimidex hos patienter med moderat og svært nedsat leverfunktion bør ske med forsigtighed (se pkt.
Administration of Arimidex in patients with hepatic impairment should be performed with caution.
Eksponeringen for anastrozol er ikke forhøjet hos patienter med svært nedsat nyrefunktion (GRF<20 ml/min., se pkt.
Exposure to anastrozole is not increased in subjects with severe renal impairment (GRF<30ml/min, see section 5.2); in patients with severe renal impairment, administration of Arimidex should be performed with caution (see section 4.2).
Eksponering for anastrozol kan øges hos patienter med nedsat leverfunktion (se pkt.
Exposure to anastrozole can be increased in subjects with hepatic impairment (see section 5.2); administration of Arimidex in patients with moderate and severe hepatic impairment should be performed with caution (see section 4.2).
Der var ingen signifikante forskelle på dette punkt i produktresuméet i de forskellige lande.
Section 4.7 Effects on ability to drive and use machines There were no significant differences between the SPC of different countries for this section.
Det anbefales at behandle dyret om aftenen.
It is recommended to treat animals in the evening.
Børn må ikke lege med behandlede katte i 4 timer efter behandlingen.
Children are not allowed to play with treated cats for 4 hours after treatment.
Brugte pipetter skal straks bortskaffes.
Used pipettes should be disposed of immediately.
DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 26/04/2019
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26/04/2019
Passende kombination af pipetter
Appropriate combination of pipettes
Pres pipetten helt sammen 3-4 gange for at tømme indholdet ud samme sted.
Squeeze the pipette firmly 3-4 times to empty the contents in one spot.
Produktet er yderst brandfarligt.
The product is highly flammable.
Pipetterne er farvede efter følgende kode:
The pipette caps are colour-coded as follows:
Pipetten tages ud af den beskyttende pakning umiddelbart før administration.
The pipette should be removed from the protective package immediately prior to administration.
ATCvet-kode: QP54AA55
ATC vet code: QP54AA55.
Opbevares under 30 °C.
Store below 30 °C.
På behandlingsdagen bør behandlede dyr ikke gives lov til at sove i samme seng som deres ejer, især børn.
On the day of treatment, treated animals should not be permitted to sleep in the same bed as their owner, especially children.
Det må ikke gives oralt eller parenteralt.
Do not administer orally or parenterally.
Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på blisterpakningen efter “EXP”.
Do not use this veterinary medicinal product after the expiry date which is stated on the blister after EXP.
Klar, farveløs til gul opløsning.
Clear, colourless to yellow solution.
Produktet dræber voksne lopper, før de lægger æg, i 5 uger.
The product kills adult fleas before they lay eggs for 5 weeks.
Produktet kan medføre øjenirritation.
The product may cause eye irritation.
Folk med følsom hud eller kendt allergi over for denne type veterinærlægemiddel, bør håndtere dette med forsigtighed.
People with sensitive skin or known allergy to veterinary medicinal products of this type should handle the veterinary medicinal product with caution.
Behovet for og hyppigheden af gentagen behandling skal være i overensstemmelse med den ordinerende dyrlæges råd og vejledning.
The need for and frequency of re-treatment should be in accordance with the advice of the prescribing veterinarian.
Interaktion med andre lægemidler og andre former for interaktion:
Interactions with other medicinal products and other forms of interactions:
Opbevaringstid for veterinærlægemidlet i salgspakning: 30 måneder.
Shelf life of the veterinary medicinal product as packaged for sale: 30 months.
Behandling af dyr med voksne hjerteorm infektion ikke udgør sikkerhedsproblemer.
The administration to animals with adult heartworm infection did not pose safety concerns.
BATCHNUMMER Lot {nummer}
BATCH NUMBER Lot {number}
Bør ikke anvendes til katte, der lider af en samtidig sygdom, eller som er invalideret eller undervægtig (i forhold til størrelse og alder).
Do not use in cats that are suffering from concomitant disease, or are debilitated and underweight (for size and age).
Dette veterinærlægemiddel er ikke virksomt mod voksne D. immitis.
This veterinary medicinal product is not effective against adult D. immitis.