natgillin/translations-raw huggingface dataset:
Topotecan Eagle er et lægemiddel, der indeholder det aktive stof topotecan.
Topotecan Eagle is a medicine that contains the active substance topotecan.
Topotecan Eagle er et ‘generisk lægemiddel'.
Topotecan Eagle is a ‘hybrid generic medicine'.
Da Topotecan Eagle er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at
Because Topotecan Eagle is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Topotecan Eagle påvirker også andre celler end kræftcellerne, hvilket
Topotecan Eagle also affects non-cancer cells, which causes side effects.
Topotecan Eagle er et lægemiddel mod kræft.
Topotecan Eagle is an anticancer medicine.
Der krævedes ingen supplerende undersøgelser, eftersom Topotecan Eagle indgives ved infusion og indeholder det samme aktive stof
No additional studies in patients were needed as Topotecan Eagle is given by infusion and contains the same active substance as the reference medicine, Hycamtin.
Hvordan anvendes Topotecan Eagle?
How is Topotecan Eagle used?
Måling af serumkoncentration
Measurement of serum concentration
Samlet resumé af den videnskabelige vurdering af Targocid og relaterede navne (se bilag I)
Overall summary of the scientific evaluation of Targocid and associated names (see Annex I)
Produktets opbevaringstid støttes af relevante stabilitetsdata.
The shelf-life of the product is supported by relevant stability data.
Det konkluderes, at batchresultaterne viser god ensartethed af fremstillingsprocessen.
It can be concluded that batch results prove good consistency of the manufacturing process.
Protokoludkast til denne ikke-interventionelle PASS forelægges senest 2 måneder efter Kommissionens afgørelse.
The study protocol of this non-interventional PASS shall be submitted within 2 months as of the Commission Decision.
Punkt 4.1 af produktresuméet omfatter ikke i alle medlemsstater den pædiatriske population.
Section 4.1 of the SmPC does not include the paediatric population in all Member States.
I alt (poolede data) behandledes 72 infektionsepisoder hos 71 voksne patienter.
In all (pooled data), 72 episodes of infection were treated in 71 adult patients.
Protokoller, sammenfatninger og endelige rapporter over undersøgelsen skal indsendes i det format, der foreskrives i bilag III til Kommissionens gennemførelsesforordning (EU) nr. 520/2012.
The protocols, abstracts and final study reports shall be submitted in the format set out in Annex III of the Commission Implementing Regulation (EC) No 520/2012.
Sikkerhedsundersøgelse efter markedsføring (PASS)
Post-authorisation safety study (PASS)
• Infektiøs endokarditis
• Infective endocarditis
De forelagte oplysninger om udvikling, fremstilling og kontrol af det færdige produkt er tilfredsstillende.
Information on development, manufacture and control of the finished product has been presented in a satisfactory manner.
Der blev forelagt et gyldigt TSE-certifikat for det aktive indholdsstof.
A valid TSE certificate was provided for the active substance.
Den kliniske helbredelses- og bedringsrate var omkring 90 %, og den bakteriologiske succesrate var 76 %.
The clinical cure and improvement rate was about 90% and bacteriological success rate was 76%.
Derudover har CHMP anbefalet de betingelser for markedsføringstilladelsen, som fremgår af bilag IV.
In addition, the CHMP has recommended conditions to the Marketing Authorisation which are set out in Annex IV.
Nogle af underkomponenterne er i virkeligheden grupper af mindre toppe, dette gælder således for A2-1, A2-3, A2-5 og A3.
Some of the subcomponents are in fact groups of smaller peaks, namely A2-1, A2-3, A2-5 and A3.
Targocid administreres ikke intravenøst, hvilket er anført som en særlig advarsel i punkt 4.4.
Targocid is not administered by the intraventricular route and is mentioned as a special warning in section 4.4.
Også lineariteten af farmakokinetikken og en erklæring vedrørende særlige populationer er medtaget i overensstemmelse med ovennævnte EU-retningslinjer.
Linearity of the pharmacokinetics as well as a statement addressing special populations has also been included, in line with the above mentioned EU guideline.
Der var behov for harmonisering af specifikationen af det aktive stof, da de godkendte grænser for de enkelte underkomponenter i nogle medlemsstater var strammere end i den gældende Ph. Eur.monografi.
Harmonisation of the active substance specification was needed as tighter limits for the individual subcomponents were approved in some Member States, compared to the current Ph. Eur.
Underkomponenterne separeres ved HPLC efter polaritet.
The subcomponents are separated by HPLC according to their polarity.
• Kliniske spørgsmål
• Clinical issues
Der blev forelagt fire kliniske undersøgelser med børn, der blev behandlet efter særlige pædiatriske protokoller, og en undersøgelse med 7 nyfødte.
Four clinical studies provided data in children treated with specific paediatric protocols, and one study that included 7 neonates.
I de fleste af dem er dosering for børn og nyfødte angivet i punkt 4.2.
In most of them the posology for children, neonates and new-borns is mentioned in section 4.2.
På ovenstående grundlag finder CHMP, at benefit/risk-forholdet for Targocid og relaterede navne er positivt, og at de harmoniserede produktinformationer kan godkendes.
Based on the above, the CHMP considers the benefit/risk ratio of Targocid and associated names to be favourable and the harmonised Product Information documents to be approvable.
Der blev udført en læsbarhedstest, som blev forelagt under indbringelsesproceduren.
A Readability Testing was performed and submitted during the referral procedure.
På grund af medlemsstaternes divergerende nationale afgørelser ved godkendelsen af Targocid og relaterede navne foretog Europa-Kommissionen en officiel indbringelse til EMA sekretariat i henhold til artikel 30 i direktiv 2001/83/EF, som ændret, med henblik på at ophæve divergenserne mellem de nationalt godkendte produktresuméer for ovennævnte produkter og dermed harmonisere de divergerende produktresuméer i EU.
Due to the divergent national decisions taken by Member States concerning the authorization of the Targocid and associated names, the European Commission notified the EMA of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised SmPCs for the above-mentioned products and thus to harmonise the SmPCs across the EU.
De refererede prækliniske sikkerhedsdata støtter disse foreslåede ændringer og fremgår af ekspertrapporten om den toksikologiske og farmakologiske dokumentation.
The preclinical safety data reported support these proposed amendments and are provided within the expert report on the toxicological and pharmacological documentation.
Ansøgeren har ikke forelagt data, der påviser fravær af effekt på ammede nyfødte og spædbørn; derfor slettes sætningen “teicoplanin forventes ikke at påvirke nyfødte/spædbørn, da det ikke optages ved oral indgift”.
The applicant has not provided data to demonstrate a lack of effect on breast-fed newborns or infants; hence the sentence “No effects on the breastfed newborns/infants are anticipated since teicoplanin is not orally absorbed” has been deleted.
Underkomponenterne af teicoplanin er blevet bedre karakteriseret.
The spectrum of teicoplanin subcomponents has been better characterised.
Der blev givet detaljerede oplysninger om udgangsmaterialer og fermenterings- og rensningsproces, som blev godkendt.
Detailed information on the starting materials, fermentation and purification process was provided and found acceptable.
Farmakokinetikken af teicoplanin ved behandling af infektioner med Clostridium difficile blev undersøgt i undersøgelse DRC342-DLI073.
The pharmacokinetics of teicoplanin for the treatment of Clostridium difficile was investigated in study DRC342-DLI073.
Resultaterne af de udførte test viser tilfredsstillende overensstemmelse og ensartethed af produkternes vigtigste kvalitetsegenskaber, hvorfor det blev konkluderet, at produkterne må forventes at have tilfredsstillende og ensartede præstationer.
The results of tests carried out indicate satisfactory consistency and uniformity of important product quality characteristics, and these in turn lead to the conclusion that these products should have a satisfactory and uniform performance.
Til infektiøs endokarditis fandt CHMP, at behandlingsperioden bør være mindst 21 dage, men at behandling ud over 4 måneder bør undgås.
For infective endocarditis, the CHMP considered that 21 days would be the minimum period of use, and that treatment beyond 4 months should be avoided.
Risikominimeringsaktiviteter
Risk minimisation activities
International Journal of COPD 40; 2012(344): 348-218.
International Journal of Antimicrobial Agents 40 (2012) 344- 348.
På grund af teicoplanins begrænsede antibakterielle spektrum er der imidlertid indsat en krydshenvisning til punkt 4.4 med en kommentar om dets begrænsede antibakterielle spektrum og rationelle anvendelse.
However due to its limited spectrum of antibacterial activity, a crossreference to section 4.4 commenting on the limited spectrum of antibacterial use and its rational use has been included.
Der er ikke konstateret nye specifikke reaktioner på overdosering med teicoplanin hos den voksne population.
No new specific reactions due to teicoplanin overdose in the adult population have been identified.
Den samlede behandlingsvarighed med teicoplanin er ikke angivet nøjagtigt, da den bør tilpasses individuelt efter den underliggende infektions art og sværhed, patientens kliniske respons og patientfaktorer såsom alder og nyrefunktion.
The overall duration of treatment with teicoplanin has not been given precisely since it should be adjusted individually, according to the underlying type and severity of infection, the clinical response of the patient and patient factors such as age and renal function.
Der var desuden enkelte tilfælde af endokarditis, luftvejsinfektioner og urinvejsinfektioner.
There were also a few cases of endocarditis, respiratory tract infections and urinary tract infections.
Da teicoplanin i de fleste medlemsstater i forvejen anvendes hos børn, og kliniske retningslinjer anbefaler dets brug hos børn, tilsluttede CHMP sig indikationen for teicoplanin hos børn, herunder nyfødte og spædbørn.
Since teicoplanin is already used in children in most member states and clinical guidelines recommend its use in children, the indication for the use of teicoplanin in children, as well as in neonates and infants was supported by the CHMP.
Desuden er indehaveren af markedsføringstilladelsen som nævnt blevet anmodet om at udføre en passende sikkerhedsundersøgelse efter markedsføring (PASS) til vurdering af sikkerheden af denne højere dosering.
Additionally, as mentioned above, the MAH has been requested to perform an appropriate PASS to evaluate the safety of this higher dosage.
Dataene blev ikke anset for tilstrækkeligt holdbare, da de bestod af åbne, sammenlignende undersøgelser, hvor teicoplanin ikke var bedre end sammenligningsstofferne.
The data was not considered to be sufficiently robust as they were open labelled comparative studies that did not demonstrate that teicoplanin was better than the comparators.
Der er fastsat grænser for hver enkelt underkomponent baseret på batchdata fra frigivelse og fra stabilitetsprøver.
Limits for all individual subcomponents were established based on batch data at release and during stability testing.
Alligevel er der under dette punkt indsat advarslen “teicoplanin bør ikke administreres intraventrikulært”.
Nevertheless a warning has been added in this section that “Teicoplanin should not be administered by intraventricular route”.
Det er et komplekst antibiotikum, der består af seks nært beslægtede glykopeptid-underkomponenter (A2-gruppen, der består af A2-1, A2-2, A2-3, A2-4 og A2-5, samt A3) som fastlagt i den gældende monografi for teicoplanin i Den Europæiske Farmakopé (Ph.
It is a complex antibiotic, consisting of six closely related glycopeptide subcomponents (A2-1, A2-2, A2-3, A2-4 and A2-5 forming A2 group, and A3) as defined in the current European Pharmacopoeia (Ph.
Nyerere time-kill-undersøgelser bekræfter, at teicoplanins baktericide virkning in vitro er optimalt testet i henhold til CLSI-retningslinjerne med tolerance fastlagt ved 24 timer.
Recent time-kill studies confirm that in vitro bactericidal activity of teicoplanin is optimally tested according to CLSI guidelines, with tolerance defined at 24 hours.
I undersøgelse EG-87-42 var det kliniske resultat for endokarditis 83 % (når der ses bort fra ikke-evaluerbare patienter).
In study EG-87-42, the clinical outcome for endocarditis was 83% (excluding patients considered as non-evaluable).
• Urinvejsinfektioner (UTI)
• Urinary tract infections (UTI)
Det foreslåede harmoniserede produktresumé er blevet opdateret med yderligere oplysninger om målorganer og reproduktionstoksicitet.
The proposed harmonised SmPC has been updated with additional information on target organs and reproductive toxicity.
Der var imidlertid enkelte tilfælde af endokarditis i de åbne undersøgelser (EG-87-42 og N-86-04), der blev udført til den oprindelige ansøgning om markedsføringstilladelse.
However a few cases of endocarditis were included in the open-label studies (EG-87-42 and N-86-04) conducted in support of the initial marketing authorisation.
Den kliniske udvikling var rettet mod følsomheden af grampositive bakterier for teicoplanin, ikke mod bestemte indikationer.
The clinical development focussed on the susceptibility of gram-positive bacteria to teicoplanin and not on specific indications.
Efter gennemgang af alle foreliggende oplysninger fandt CHMP, at denne indikation bør bibeholdes i det harmoniserede produktresumé.
Considering all the available information, the CHMP agreed that this indication should remain in the harmonised SmPC.
Disse tre undersøgelser viste, at der med teicoplanin opnås en klinisk og bakteriologisk total responsrate på næsten 90 % hos dyrkningsog toksinpositive patienter.
The results from these three studies showed that teicoplanin achieves an overall clinical and bacteriological response rate of nearly 90% in culture and toxin positive patients.
For koagulasenegative stafylokokker (CoNS) er resistens-breakpointet >4 mg/ml.
For coagulase-negative staphylococci (CoNS), the resistance breakpoint is >4 mg/ml.
Indikationen blev derfor indskrænket til komplicerede urinvejsinfektioner, hvilket godkendtes af CHMP.
The indication was therefore restricted to complicated urinary tract infections, which was accepted by the CHMP.
Som følge af de mange ændringer i produktresuméet er der en række tilsvarende ændringer af indlægssedlen.
Following all the changes in the SPC there are several corresponding changes to the Package Leaflet.
Under vedligeholdelsesbehandlingen anbefales desuden måling af serum-dalkoncentrationerne mindst én gang ugentligt.
Measurement of trough serum concentrations is also recommended at least once a week during the maintenance treatment.
Undersøgelserne var små, og de kliniske erfaringer med teicoplanin til nyfødte, spædbørn og børn er begrænsede.
These studies were small and clinical experience with teicoplanin in neonates, infants and children is limited.
Virkningen af teicoplanin blev påvist klinisk og bakteriologisk i både den europæiske multicenterundersøgelse og den amerikanske åbne multicenterundersøgelse.
The clinical and bacteriological efficacy of teicoplanin was shown in both the European Multicentre Study and in the US open multicentre study.
I den europæiske multicenterundersøgelse EG-87-42 havde ca. 9 % af patienterne nedre luftvejsinfektioner.
In Study EG-87-42, the European multi-centre study, approximately 9% of the subjects enrolled had lower respiratory tract infections.
En initialdosering på 12 mg/kg to gange dagligt svarer til de nuværende anbefalinger i produktresuméerne i Frankrig og Finland.
The loading dose of 12mg/kg bid is in line with what is currently recommended in the SmPCs in France and Finland.
De kliniske undersøgelser omfattede to åbne, ikke-sammenlignende terapeutiske undersøgelser: den europæiske multicenterundersøgelse (EG-87-42) og den amerikanske åbne multicenterundersøgelse (N-86-04) samt et resume af de sammenlignende undersøgelser med teicoplanin (EG-87-35).
The clinical studies included two open-label non-comparative therapeutic studies; the European Multicentre Study (EG-87-42) and the US Open Multicentre Study (N-86-04) and a review of the comparative studies conducted with teicoplanin (EG-87-35).
Oplysningerne om det aktive indholdsstof blev forelagt i en Active Substance Master File (ASMF).
Information on the active substance was submitted in an ASMF.
• udvalget behandlede de konstaterede divergenser i produktinformationen for Targocid og relaterede navne vedrørende afsnittene om terapeutiske indikationer, dosering og administration, kontraindikationer og særlige advarsler og forsigtighedsregler vedrørende brugen foruden de øvrige afsnit i produktresuméet,
• The Committee considered the identified divergences in the product information for Targocid and associated names with respect to the therapeutic indications, posology and method of administration sections, contraindications and special warnings and precautions for use, as well as the remaining sections of the SmPC.
Det mikrobiologiske spektrum af teicoplanin dækker stafylokokker, herunder meticillinfølsomme og meticillinresistente Staphylococcus aureus, Streptococcus pneumoniae og andre streptokokker, hovedsagelig Streptococcus pyogenes, streptokokker i viridans-gruppen og Enterococcus faecalis.
The microbiological spectrum of teicoplanin covers staphylococci including Staphylococcus aureus susceptible or resistant to methicillin, Streptococcus pneumoniae and other streptococci mainly including Streptococcus pyogenes, streptococci in the Viridans group and Enterococcus faecalis.
Det blokerer syntesen af peptidoglycaner ved specifik binding til D-alanyl-D-alanin-rester.
Peptidoglycan synthesis is blocked by specific binding to D-alanyl-D-alanine residues.
Videnskabelige konklusioner og begrundelse for ændringen af betingelserne for markedsføringstilladelsen
Annex II Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation
Størstedelen af patienterne i undersøgelse EG-87-42 (som er den største af de to ikke-sammenlignende undersøgelser) havde grampositive infektioner med forskellig lokalisering, hovedsagelig infektioner i hud og underliggende væv (SSTI), septikæmi og infektioner i knogler og led.
Most of the patients included in study EG-87-42 (which was the larger of the two non-comparative studies) had suspected gram-positive infections from different sites, with the majority of them having skin and soft tissues infections (SSTIs), septicaemia and bone and joint infections.
CHMP tilsluttede sig derfor markedsføringstilladelsesindehaverens forslag om, at teicoplanin, når det er hensigtsmæssigt, bør anvendes i kombination med andre antimikrobielle midler som nævnt i krydshenvisningen i punkt 4.4.
Therefore the CHMP was in agreement with the MAH's proposal that teicoplanin should be used in combination with other anti-microbial agents when appropriate,as cross-referenced in section 4.4.
Der er ikke opstillet en farmakokinetisk-farmakodynamisk model, men den ansøgte dosering til børn bygger på Monte Carlo-simuleringer foretaget af Lucas et al i 2004 3og Reed i 19974, hvilket CHMP godtog.
Although no PK-PD modelling has been done, the proposed posology for children is based on Monte Carlo simulations conducted by Lucas et al in 2004 3and Reed in 19974, which was considered to be acceptable by the CHMP.
Markedsføringstilladelsen gøres betinget af, at denne PASS udføres.
This PASS is imposed as a condition to the Marketing Authorisation.
Dossieret for det færdige produkt er opdateret med undersøgelser af forligelighed med forskellige typer solvenser, PVC-poser og sprøjter samt undersøgelse af stabilitet i brug.
The finished product dossier was updated to include compatibility studies with various types of diluents, PVC bags and syringes, together with in-use stability data.
3 Fink JC, Blahut SA, Reddy M, et al. Pharmacokinetics of teicoplanin in an ICU population of children and infants.
3 Lucas JC, Karikas G, Gazouli M, et al. Pharmacokinetics of teicoplanin in an ICU population of children and infants.
Indehaveren af markedsføringstilladelsen indsender protokollen for undersøgelsen til Det Europæiske Lægemiddelagentur og til PRAC som fastlagt i GVP modul VIII (tillæg I).
The MAH shall submit the study protocol for assessment to the European Medicines Agency and to the PRAC in line with requirements of GVP module VIII (Addendum I).
Vedrørende interaktioner med teicoplanin vides det, der på grund af potentialet for øgede bivirkninger bør udvises forsigtighed ved anvendelse til patienter i samtidig behandling med nefrotoksiske eller ototoksiske lægemidler såsom aminoglykosider, amphotericin B, ciclosporin og furosemid.
Regarding interactions with teicoplanin, it is known that due to the potential for increased adverse effects, teicoplanin should be administered with caution in patients receiving concurrent nephrotoxic or ototoxic drugs, such as aminoglycosides, amphotericin B, ciclosporin, and furosemide.
I produktresuméet for teicoplanin er harmoniseringen af det farmakokinetiske afsnit dels baseret på data fra den oprindelige ansøgning om markedsføringstilladelse, dels nyere data fra en litteratursøgning.
The harmonization of the pharmacokinetic section in the teicoplanin SmPC is based on the data first provided in the initial marketing authorisation application, and more recent data retrieved from a literature research.
Virkningen af teicoplanin til behandling af infektioner med grampositive organismer var omfattet af en række kliniske undersøgelser, der sammen med litteraturhenvisninger blev forelagt ved den oprindelige godkendelse.
The efficacy of teicoplanin in the treatment of Gram-positive infections has been investigated in a number of clinical studies that were submitted in the initial authorisation along with literature references.
Der blev ikke forelagt data som støtte for en erklæring om “kramper efter intraventrikulær administration”.
No supportive data for the inclusion of the statement “convulsions after intraventricular administration” was retrieved.
Indikationen profylaktisk anvendelse af teicoplanin blev derfor ikke godtaget af CHMP.
Therefore the indication for the prophylactic use of teicoplanin was not considered to be acceptable by the CHMP.
Denne indikation anbefales imidlertid ikke i de gældende retningslinjer for behandling af infektiøs endokarditis som udpeget af indehaveren af markedsføringstilladelsen, hvorfor CHMP anså det for acceptabelt at slette den.
However this indication is not recommended in current guidelines on the management of infective endocarditis as pointed out by the MAH, and therefore the deletion of this indication was considered to be acceptable by the CHMP.
PASS-protokollen skal også indgå i risikostyringsplanen.
The PASS protocol should also be included in the RMP.
Indehaveren af markedsføringstilladelsen har ændret punkt 4.3, så det kun omfatter overfølsomhed over for teicoplanin (eller over for et eller flere af hjælpestofferne).
The MAH has amended section 4.3 only including hypersensitivity to teicoplanin (or to any of the excipients).
Før påbegyndelse af dataindsamling skal undersøgelsens protokol være indført i det elektroniske EU-register over undersøgelser efter markedsføring (EU's PAS-register).
The study protocol shall be entered in the EU electronic register of postauthorisation studies (EU PAS Register) before the start of data collection.
Teicoplanin hæmmer væksten af følsomme organismer ved at gribe ind i biosyntesen af cellevæggen på et andet sted end det, der angribes af ß-lactamantibiotika.
Teicoplanin inhibits the growth of susceptible organisms by interfering with cell-wall biosynthesis at a site different from that affected by beta-lactam antibiotics.