natgillin/translations-raw huggingface dataset:
The results show that free drug for each teicoplanin subcomponent was similar.
Rezultati kažejo, da je prosto zdravilo za vsako podkomponento teikoplanina podobno.
The Applicant concluded that there are many recent references recommending that the dose of teicoplanin is adjusted based on the monitoring of blood levels and that the guidance in the proposed SPC provides a solid baseline for managing patients requiring teicoplanin.
Predlagatelj je zaključil, da obstaja več novejših virov, ki priporočajo prilagajanje odmerka teikoplanina na osnovi spremljanja ravni v krvi ter da so smernice v predlogu povzetka glavnih značilnosti zdravila dobro izhodišče za obravnavo bolnikov, ki potrebujejo teikoplanin.
Ground 3: Furthermore the submitted additional non-clinical and serum bactericidal data are not considered sufficient to adequately demonstrate that Teicoplanin Hospira is a generic of the innovator Targocid
Podlaga 3: Poleg tega se predloženi dodatni nekliničnih podatki in podatki o baktericidnosti seruma ne štejejo za zadostne za ustrezen dokaz, da je zdravilo Teicoplanin Hospira generično zdravilo inovatorskega zdravila Targocid.
Therefore, PK/PD relationships for antimicrobials are based on free drug.
Zato zveze v okviru farmakokinetike in farmakodinamike temeljijo na prostem zdravilu.
The CHMP endorsed the answer of the Applicant, from a pharmacodynamic point of view, free AUC is the most important PK parameter.
CHMP je potrdil odgovor predlagatelja, da je z vidika farmakodinamike AUC prostega zdravila najpomembnejši parameter farmakokinetike.
The Applicant conducted a bioequivalence study to provide further information on the PK/PD and to demonstrate similar safety and efficacy.
Predlagatelj je opravil študijo biološke enakovrednosti, s katero je želel pridobiti dodatne informacije o farmakokinetiki in farmakodinamiki ter dokazati podobno varnost in učinkovitost.
Both products include the same subcomponents and despite differences in the subcomponent ratios, both comply with the European Pharmacopoeia (Ph.Eur.)
Zdravili vsebujeta iste podkomponente in kljub razlikam v razmerju podkomponent ustrezata monografiji Evropske farmakopeje (Ph.
The half- lives of the TA2 components correlates to their lipophilicity, and because Teicoplanin Hospira has a lower proportional content of subcomponents with a longer half-life and a higher proportion with a shorter half-life, the overall elimination of total teicoplanin is faster, and the resulting AUC is lower.
Ker zdravilo Teicoplanin Hospira vsebuje manjši delež podkomponent z daljšo razpolovno dobo in višji delež komponent s krajšo razpolovno dobo, je končna eliminacija skupnega teikoplanina hitrejša, nastala AUC pa nižja.
The Applicant concluded that taking into account the teicoplanin subcomponents and their relative amounts, lipophilicity and MIC's, numerous experts believe that in a clinical setting, teicoplanin should be treated as a whole, regardless of the relative levels of subcomponents, due to the differences in PK characteristics being small.
Predlagatelj je menil, da številni strokovnjaki ob upoštevanju podkomponent teikoplanina in njihovih relativnih količin, lipofilnosti in vrednosti MIC menijo, da bi bilo treba v kliničnem okolju teikoplanin šteti kot celoto ne glede na relativne ravni podkomponent, ker so razlike v značilnostih farmakokinetike majhne.
As the additional non-clinical and serum bactericidal data submitted are not sufficient to adequately demonstrate that Teicoplanin Hospira is a generic of Targocid, the CHMP therefore maintained its previous opinion that the current application for this product is not approvable.
Ker predloženi dodatni nekliničnih podatki in podatki o baktericidnosti seruma niso zadostni za dokaz, da je zdravilo Teicoplanin Hospira generično zdravilo zdravila Targocid, je CHMP ohranil svoje prejšnje mnenje, da trenutne vloge za pridobitev dovoljenja za to zdravilo ni mogoče odobriti.
The CHMP considers that with respect to pharmacodynamics, the study demonstrated that serum bactericidal activity was similar for both the Teicoplanin Hospira and Targocid and that the free drug proportion for each sub-component was similar for the two products.
CHMP meni, da je študija v smislu farmakodinamike dokazala, da je bila serumska baktericidna aktivnost enaka pri zdravilu Teicoplanin Hospira in zdravilu Targocid ter da je delež prostega zdravila za vsako podkomponento podoben pri obeh zdravilih.
The CHMP noted that the proposed specifications result in a considerably greater control of the individual subcomponents than if they had simply been in line with the monographs; however this does not establish that Teicoplanin Hospira is a generic of Targocid.
CHMP je upošteval, da predlagane specifikacije omogočajo bistveno večji nadzor posameznih podkomponent, kot če bi bile skladne z monografijami, vendar to ne dokazuje, da je zdravilo Teicoplanin Hospira generično zdravilo zdravila Targocid.
EUCAST reported values for the whole (total) teicoplanin should be used instead.
Uporabiti bi bilo treba vrednosti za celotni (skupni) teikoplanin, o katerih je poročal EUCAST.
In conclusion, the CHMP noted that although complying with the European Pharmacopoeia monograph, the quality of Teicoplanin Hospira is different from the innovator subcomponents as Teicoplanin Hospira does not meet the originator specifications with respect to the individual glycopeptides subcomponents.
CHMP je na koncu izpostavil, da je kakovost zdravila Teicoplanin Hospira kljub skladnosti z monografijo Evropske farmakopeje drugačna od podkomponent inovatorskega zdravila, saj zdravilo Teicoplanin Hospira z vidika posameznih glikopeptidnih podkomponent ne izpolnjuje specifikacij originatorskega zdravila.
The CHMP was of the opinion that compliance with the specifications of the European Pharmacopoeia does not automatically imply that Teicoplanin Hospira is a generic of Targocid and maintained that demonstrating this is crucial for approval.
CHMP je menil, da skladnost s specifikacijami Evropske farmakopeje samodejno ne pomeni, da je zdravilo Teicoplanin Hospira generično zdravilo zdravila Targocid, in da je dokaz slednjega ključen za odobritev zdravila.
The CHMP was also of the opinion that the study conducted by the Applicant did not demonstrate bioequivalence between Teicoplanin Hospira and Targocid and that the MIC studies are not sensitive enough to detect differences between the two products in the case of teicoplanin, since in vitro anti-bacterial activity is independent of lipophilicity, tissue distribution and clearance of the subcomponents, i.e. differences in systemic exposure.
CHMP je menil tudi, da študija, ki jo je opravil predlagatelj, ni dokazala biološke enakovrednosti med zdraviloma Teicoplanin Hospira in Targocid, in da študije MIK niso bile dovolj občutljive, da bi zaznale razliko med zdraviloma, saj je protibakterijska aktivnost in vitro neodvisna od lipofilnosti, porazdelitve v tkivih ali očistka podkomponent, tj. razlik v sistemski izpostavljenosti.
Regarding the available literature concluding that Teicoplanin should be treated as a whole regardless of the relative levels of subcomponents, the CHMP is of the opinion that this would have been considered during the development of the Ph.Eur.
CHMP glede na razpoložljivo literaturo z zaključki, da je treba teikoplanin šteti kot celoto ne glede na relativne ravni podkomponent, meni, da bi bilo to treba upoštevati med razvojem monografije Ph. Eur.
Although the EMEA guideline for bioequivalence states that a bioequivalence study is not required for IV products, this study provided useful additional information.
Čeprav smernice EMEA za biološko enakovrednosti določajo, da se študija biološke enakovrednosti ne zahteva za i.v.
Finally, the in vitro MIC studies performed by the Applicant are not sensitive enough to detect any differences between the two products since in vitro anti-bacterial activity is independent of lipophilicity, tissue distribution and clearance of the subcomponents.
Poleg tega študije MIC in vitro, ki jih je opravil predlagatelj, niso dovolj občutljive, da bi zaznale razliko med zdraviloma, saj je protibakterijska aktivnost in vitro neodvisna od lipofilnosti, porazdelitve v tkivih ali očistka podkomponent.
In conclusion, the CHMP considers that the difference in concentration of the glycopeptide subcomponents precludes Teicoplanin Hospira being a considered a generic of Targocid, despite the composition being in line with the JP monograph and the draft Ph.Eur monograph.
CHMP torej meni, da zaradi razlik v koncentraciji podkomponent glikopeptida zdravila Teicoplanin Hospira ne moremo šteti za generično zdravilo zdravila Targocid, čeprav je sestava skladna z monografijo JP in osnutkom monografije Ph. Eur.
The results of the phase I study failed to demonstrate PK equivalence for total drug exposure.
Rezultati študije faze I niso dokazali farmakokinetične enakovrednosti skupne izpostavljenosti zdravilu.
Protein binding was assessed, showing that the unbound fraction for each sub-component was essentially similar for Targocid and Teicoplanin Hospira and confirming that the individual protein binding values for the subcomponents did not vary with the different component composition.
Pri oceni vezave na beljakovine so ugotovili, da je nevezana frakcija vsake podkomponente v osnovi podobna med zdraviloma Targocid in Teicoplanin Hospira, in potrdili, da se posamezne vrednosti vezave na beljakovine za podkomponente ne razlikujejo med različnimi sestavami komponent.
The Applicant undertook an extensive testing program to characterise the activity of Teicoplanin Hospira versus Targocid against a series of clinically relevant species and demonstrated essential similarity between Teicoplanin Hospira and Targocid for all individual strains and species.
Predlagatelj je izvedel obsežen program preskušanja, s katerim je želel opredeliti aktivnost zdravila Teicoplanin Hospira v primerjavi z zdravilom Targocid proti številnim klinično pomembnim vrstam bakterij, ter dokazati osnovno podobnost med zdraviloma Teicoplanin Hospira in Targocid za vse bakterijske seve in vrste.
The Applicant is therefore requested to further justify that Teicoplanin Hospira is a generic of Targocid in writing and/or at an Oral Explanation in light of the CHMP opinion.“ The Applicant decided to address the List of Outstanding Issues during an oral explanation.
Predlagatelja zato prosimo, da glede na mnenje CHMP dodatno utemelji trditev, da je zdravilo Teicoplanin Hospira generično zdravilo zdravila Targocid, pisno in/ali ustno.“ Predlagatelj se je odločil obravnavati seznam nerešenih vprašanj ustno.
The CHMP requested the Applicant to further discuss their claim that Teicoplanin Hospira is a generic of Targocid.
CHMP je zahteval, da predlagatelj znova premisli o trditvi, da je zdravilo Teicoplanin Hospira generično zdravilo zdravila Targocid.
The Applicant also discussed the data from the neutropenic mouse thigh infection study, arguing that the results clearly show that Teicoplanin Hospira and Targocid were equally effective in reducing bacterial count, confirming that the differences in relative composition of individual components do not affect the biological activity of the product.
Predlagatelj je razpravljal tudi o podatkih iz študije okužbe stegna pri nevtropeničnih miškah z argumenti, da rezultati jasno kažejo enako učinkovitosti zdravil Teicoplanin Hospira in Targocid pri zmanjševanju števila bakterij, s čimer je potrjeno, da razlike v relativni sestavi posameznih komponent ne vplivajo na biološko aktivnost zdravila.
- Teicoplanin Hospira does not meet the originator specifications with respect to the individual glycopeptides subcomponents and has shown to be bio-inequivalent to the originator
- zdravilo Teicoplanin Hospira z vidika posameznih glikopeptidnih podkomponent ne izpolnjuje specifikacij originatorskega zdravila in zanj je bila dokazana biološka neenakovrednost z originatorskim zdravilom,
The Applicant considers that the achieved product is in line with the published EDQM teicoplanin monograph, but stated that only the originator MAH was invited to comment on this monograph, and that comments submitted by Hospira were not accepted.
Predlagatelj meni, da je doseženo zdravilo skladno z objavljeno monografijo EDQM za teikoplanin, vendar navaja, da je bil k razpravi o tej monografiji povabljen le imetnik dovoljenja za promet z originatorskim zdravilom ter da predlogi družbe Hospira niso bili sprejeti.
The Applicant stated that the antimicrobial potency of the drug is a sum of the component parts and that In vitro antibacterial potency is established by MIC testing.
Predlagatelj je navedel, da je protimikrobna jakost zdravila vsota vseh komponent in da je protimikrobna jakost in vitro dokazana z določanjem vrednosti MIK.
Teicoplanin Hospira has a different sub-component mix to the originator; however the Applicant considers that it is not reasonable to use total teicoplanin MICs to assess the impact of differing proportions of subcomponents.
Zdravilo Teicoplanin Hospira ima drugačno zmes podkomponent kot originatorsko zdravilo, vendar predlagatelj meni, da pri ugotavljanju učinka različnih deležev podkomponent ni utemeljeno uporabljati MIK za skupni teikoplanin.
The pharmacokinetics of teicoplanin has been determined for both the total complex and for the individual components and analyses of the subcomponents confirmed that the pharmacokinetics of the individual TA2 subcomponents are the same for Teicoplanin Hospira and Targocid.
Farmakokinetika teikoplanina je bila določena za skupni kompleks in za posamezne komponente, analize podkomponent pa so potrdile, da je farmakokinetika posameznih podkomponent TA2 enaka za zdravilo Teicoplanin Hospira in zdravilo Targocid.
The Applicant considered that the PK results for whole teicoplanin demonstrated that Cmax and Tmax of Teicoplanin Hospira and Targocid were essentially similar, and the 90% CI for Cmax was within the acceptance range for bioequivalence.
Predlagatelj je menil, da rezultati farmakokinetike skupnega teikoplanina kažejo, da sta vrednosti Cmax in Tmax za zdravili Teicoplanin Hospira in Targocid v osnovi enaki, 90-odstotni interval zaupanja za Cmax pa znotraj sprejemljivega razpona za biološko enakovrednost.
The Applicant then defined the active ingredient by referring to the INN and the pharmacopoeial monographs, concluding that Teicoplanin Hospira meets all of the criteria necessary to define it as a generic of the originator product.
Predlagatelj je opredelil zdravilno učinkovino s sklicevanjem na INN in farmakopejske monografije z zaključkom, da zdravilo Teicoplanin Hospira izpolnjuje vse kriterije, potrebne za opredelitev, da je zdravilo Teicoplanin Hospira generično zdravilo originatorskega zdravila.
The main issue for consideration was the failure to demonstrate that Teicoplanin Hospira is a generic of Targocid.
Glavno vprašanje obravnave je bil neuspešen dokaz, da je zdravilo Teicoplanin Hospira generično zdravilo zdravila Targocid.
The Applicant acknowledged that AUC 0-tlast and AUC 0-inf were below the accepted range, indicating that the two preparations were not PK equivalent for total drug exposure.
Predlagatelj je potrdil, da sta bili AUC 0-tlast in AUC 0-inf precej pod sprejemljivim razponom, kar kaže, da pripravka nista bila farmakokinetično enakovredna v smislu skupne izpostavljenosti zdravilu.
Results from animal studies do not supersede comparative PK data from a clinical study in the evaluation of abridged products.
Rezultati iz študij na živalih pri ocenjevanju zdravil s skrajšanim postopkom ne nadomeščajo komparativnih farmakokinetičnih podatkov iz klinične študije.
The mouse thigh infection model study was considered to be representative of deep seated infections and provides a comparison of the tissue penetration characteristics of Teicoplanin Hospira and Targocid.
Model okužbe stegna mišk se je štel za reprezentativnega za globoke okužbe, hkrati pa omogoča primerjavo zmogljivosti prodiranja zdravil Teicoplanin Hospira in Targocid v tkivo.
Subsequently, therapeutic drug monitoring is important to ensure that dose regimens are optimized and that it is recommended that teicoplanin are monitored and dosage adjusted to ensure trough levels of at least 20mg/L.
Priporoča se, da se teikoplanin spremlja in odmerek prilagaja s ciljem najnižje ravni vsaj 20 mg/L.
Therefore, the Applicant considers Teicoplanin Hospira to be a generic of Targocid.
Zato predlagatelj meni, da je zdravilo Teicoplanin Hospira generično zdravilo zdravila Targocid.
It was however noted that tissue concentrations of drug components were not measured and that regarding the toxicology, it cannot be concluded whether the products are comparable as the histopathology was investigated only for Teicoplanin Hospira.
Glede toksikologije pa ni možno ugotoviti, ali so zdravila primerljiva, saj je bila histopatologija raziskana le za zdravilo Teicoplanin Hospira.
The study concluded that the biological activity of Teicoplanin Hospira is equivalent to that of Targocid and therefore confirmed that the minor differences in the composition of individual active components of teicoplanin do not affect the biological activity.
Teicoplanin Hospira enakovredna zdravilu Targocid, in s tem potrdili, da majhne razlike v sestavi posamezne zdravilne učinkovine teikoplanina ne vplivajo na biološko aktivnost.
However, the validity and sensitivity of free AUC and PK/PD parameters in the evaluation of a generic product have not been established, and this approach contravenes the CHMP guideline on the Investigation of Bioavailability and Bioequivalence.
Vendar veljavnost in občutljivost parametrov AUC prostega zdravila ter farmakokinetike in farmadinamike pri ocenjevanju generičnega zdravila niso bili dokazani.
Phase 1 Clinical PK/PD
Klinična farmakokinetika in farmakodinamika faze 1
The related substances resulting from the fermentation process are well documented and the Applicant undertook a toxicity study program to demonstrate a similar safety profile to that of the originator.
Predlagatelj je tudi opravil program študij toksičnosti za dokaz podobnosti varnostnega profila z originatorskim zdravilom.
However, these results are not considered to demonstrate that Teicoplanin Hospira is a generic of Targocid, with regards to overall similarity.
Vendar ti rezultati ne štejejo za dokaz, da je zdravilo Teicoplanin Hospira generično zdravilo zdravila Targocid.
The nature of the active substance and the fermentation process used may lead to subcomponent differences, affecting the lipophilicity of the drug and as such the PK and indeed, the PK data indicates that for AUC, bioequivalence could not be shown.
Narava zdravilne učinkovine in uporabljenega fermentacijskega procesa lahko povzroči razlike v podkomponentah, kar vpliva na lipofilnost zdravila in s tem na farmakokinetiko.
It must therefore be demonstrated that the subcomponent ratio differences do not result in efficacy and/or safety differences and the CHMP is of the opinion that the clinical and non-clinical data and the bioequivalence trials provided are insufficient to demonstrate this.
CHMP meni, da predloženi klinični in neklinični podatki ter preskušanja biološke enakovrednosti ne zadostujejo za dokaz omenjenega.
Intravenous use 200 mg/vial
200 mg prašek in vehikel za intravenska uporaba
The free drug AUC/MIC for the sum of TA2 subcomponents for Teicoplanin Hospira was within 2% of the Targocid value and the totality of the pre-clinical MIC studies combined with the mouse thigh study and the identical bactericidal serum titres give re-assurance that the microbiological activity of the two products is the same and that pharmacodynamically, the two products can be considered equivalent.
AUC/MIK prostega zdravila za vsoto podkomponent TA2 zdravila Teicoplanin Hospira je bila znotraj 2 % vrednosti pri zdravilu Targocid, celovitost predkliničnih študij MIK
However, AUC 0-tlast and AUC 0-inf were lower for Teicoplanin Hospira, indicating that PK equivalence was not shown for the total (bound plus unbound) drug exposure.
Predlagatelj je potrdil, da sta bili AUC 0-tlast in AUC 0-inf precej pod sprejemljivim razponom, kar kaže, da pripravka nista bila farmakokinetično enakovredna v smislu skupne izpostavljenosti zdravilu (vezana in nevezana).
This means that it works on the immune system (the body's natural defences).
To pomeni, da deluje na imunski sistem (naravne obrambne mehanizme telesa).
The European Commission granted a marketing authorisation valid throughout the European Union for Protopic on 28 February 2002.
Evropska komisija je dovoljenje za promet z zdravilom Protopic, veljavno po vsej Evropski uniji, odobrila dne 28. februarja 2002.
If there is no improvement after two weeks, the doctor should consider other treatment options.
Če po dveh tednih zdravljenja ni znakov izboljšanja, mora zdravnik pretehtati druge možnosti zdravljenja.
Protopic treatment should begin as soon as symptoms appear.
Zdravljenje z zdravilom Protopic je treba začeti takoj, ko se pojavijo simptomi.
Generally, improvement is seen within one week of starting treatment.
Izboljšanje je praviloma opazno v enem tednu po začetku zdravljenja.
The full EPAR for Protopic can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Protopic je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This is a summary of the European public assessment report (EPAR) for Protopic.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Protopic.
Tacrolimus has been used since the mid-1990s to help prevent rejection in transplant patients (when the immune system attacks the transplanted organ).
Takrolimus se od sredine devetdesetih let prejšnjega stoletja uporablja za preprečevanje zavrnitve presadka pri bolnikih po presaditvi (ko imunski sistem napade presajeni organ).
‘Atopic' means that the dermatitis is linked to an allergy.
„Atopičen“ pomeni, da je dermatitis povezan z alergijo.
The main measure of effectiveness was the number of flare-ups the patients had over a year.
Glavno merilo učinkovitosti je bilo število ponovnih izbruhov bolezni pri bolnikih v enem letu.
The main measure of effectiveness was the improvement in the eczema seen at the end of the studies, after three or 12 weeks, using a scoring system that looks at all of the symptoms of atopic dermatitis.
Glavno merilo učinkovitosti je bilo izboljšanje ekcema na koncu študije po treh ali 12 tednih na podlagi sistema točkovanja, ki zajema vse simptome atopičnega dermatitisa.
For more information about treatment with Protopic, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Protopic preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
Protopic is an ointment that contains the active substance tacrolimus (0.1% and 0.03%).
Zdravilo Protopic je mazilo, ki vsebuje zdravilno učinkovino takrolimus (0,1 % in 0,03 %).
The CHMP decided that Protopic's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Protopic večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
All of the patients had atopic dermatitis that had responded to a maximum of six weeks of previous treatment with Protopic.
Vsi bolniki so imeli atopični dermatitis, ki se je odzval na največ šesttedensko predhodno zdravljenje z zdravilom Protopic.
Protopic should be prescribed by a doctor with experience in the diagnosis and treatment of atopic dermatitis.
Zdravilo Protopic lahko predpiše zdravnik, ki imajo izkušnje s postavljanjem diagnoze in zdravljenjem atopičnega dermatitisa.
What benefit has Protopic shown during the studies?
Kakšne koristi je zdravilo Protopic izkazalo med študijami?
In children, this should include suspension of treatment to allow the doctor to assess whether continued treatment for the disease is necessary.
Pri otrocih je treba zdravljenje prekiniti, da lahko zdravnik ugotovi, ali je nadaljnje zdravljenje potrebno.