natgillin/translations-raw huggingface dataset:
What is Topotecan Eagle? 
Kaj je zdravilo Topotecan Eagle?
How does Topotecan Eagle work? 
Kako zdravilo Topotecan Eagle deluje?
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. 
Zdravilo Topotecan Eagle se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Hycamtin, zato niso bile potrebne nobene dodatne študije z bolniki.
What is Topotecan Eagle used for? 
Za kaj se zdravilo Topotecan Eagle uporablja?
How is Topotecan Eagle used? 
Kako se zdravilo Topotecan Eagle uporablja?
Risk management plan (RMP) 
Načrt za obvladovanje tveganja (RMP)
Measurement of serum concentration 
Merjenje serumske koncentracije
• The Committee considered the referral under Article 30 of Directive 2001/83/EC 
• Odbor je upošteval napotitev v skladu s členom 30 Direktive 2001/83/ES;
• Bacteraemia/ Septicaemia / Sepsis 
• Bakteriemija/septikemija/sepsa
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. 
Protokoli, povzetki in zaključna poročila o študiji bodo predložena v obliki, kot je navedena v Prilogi III Izvedbene uredbe Komisije (EU) št. 520/2012.
The PASS protocol should also be included in the RMP. 
V RMP mora biti vključen tudi protokol PASS.
Overall summary of the scientific evaluation of Targocid and associated names (see Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravila Targocid in povezanih imen (glejte Prilogo I)
Risk minimisation activities 
Dejavnosti za zmanjšanje tveganja
Information on development, manufacture and control of the finished product has been presented in a satisfactory manner. 
Informacije o razvoju, proizvodnji in nadzoru končnega zdravila so bile zadovoljivo predstavljene.
It can be concluded that batch results prove good consistency of the manufacturing process. 
Zaključiti je mogoče, da rezultati serije dokazujejo dobro doslednost proizvodnega procesa.
Measurement of trough serum concentrations is also recommended at least once a week during the maintenance treatment. 
Merjenje najmanjših serumskih koncentracij je prav tako priporočeno vsaj enkrat na teden med vzdrževalnim zdravljenjem.
In all (pooled data), 72 episodes of infection were treated in 71 adult patients. 
V vseh primerih skupaj (skupni podatki) so zdravili 72 epizod okužb pri 71 odraslih bolnikih.
Targocid is not administered by the intraventricular route and is mentioned as a special warning in section 4.4. 
Zdravilo Targocid se ne daje po intraventrikularni poti in je omenjeno kot posebno opozorilo v poglavju 4.4.
Four clinical studies provided data in children treated with specific paediatric protocols, and one study that included 7 neonates. 
Štiri klinične študije so zabeležile podatke pri otrocih, ki so prejemali zdravljenje s posebnimi pediatričnimi protokoli, ena študija pa je vključevala 7 novorojenčkov.
The clinical cure and improvement rate was about 90% and bacteriological success rate was 76%. 
Odstotek klinične ozdravitve in izboljšanja je znašal okrog 90 %, odstotek bakteriološkega uspeha pa 76 %.
Some of the subcomponents are in fact groups of smaller peaks, namely A2-1, A2-3, A2-5 and A3. 
Nekatere od podkomponent so v bistvu skupine manjših vrhov, zlasti A2-1, A2-3, A2-5 in A3.
The study protocol of this non-interventional PASS shall be submitted within 2 months as of the Commission Decision. 
Protokol te neintervencijske študije varnosti zdravila po pridobitvi dovoljenja za promet bo predložen v dveh mesecih po sklepu Komisije.
Detailed information on the starting materials, fermentation and purification process was provided and found acceptable. 
Podrobne informacije o začetnih materialih, postopku fermentacije in čiščenja so bile predložene in sprejemljive.
In most of them the posology for children, neonates and new-borns is mentioned in section 4.2. 
V večini od njih je odmerjanje za otroke in novorojenčke omenjeno v poglavju 4.2.
Linearity of the pharmacokinetics as well as a statement addressing special populations has also been included, in line with the above mentioned EU guideline. 
Vključeni sta bili tudi linearnost farmakokinetike in izjava o posebni populaciji, kar je v skladu z zgoraj omenjenimi smernicami EU.
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. 
Glede infektivnega endokarditisa je odbor CHMP menil, da bi bilo 21 dni najkrajše obdobje uporabe in da se je treba zdravljenju, daljšem od 4 mesecev, izogibati.
The shelf-life of the product is supported by relevant stability data. 
Rok uporabnosti zdravila podpirajo ustrezni podatki o stabilnosti.
Section 4.1 of the SmPC does not include the paediatric population in all Member States. 
Poglavje 4.1 povzetka glavnih značilnosti zdravila ne vključuje pediatrične populacije v vseh državah članicah.
Chemother 1997 ; 39: 789-96. 
J Antimicrob Chemother 1997; 39: 789−96.
As ‘Sepsis' is generally a secondary condition to a primary site infection, it was not considered to be acceptable as a stand-alone indication, and was therefore deleted from the list of indications. 
Ker je „sepsa“ na splošno sekundarno stanje na primarnem mestu okužbe, sepsa ni bila upoštevana kot sprejemljiva za samostojno indikacijo in je bila zato izbrisana s seznama indikacij.
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. 
Podatki niso bili dovolj robustni, saj odprte primerjalne študije niso pokazale, da je teikoplanin boljši od primerljivih zdravil.
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. 
Rezultati teh treh študij so pokazali, da teikoplanin dosega skupni delež kliničnega in bakteriološkega odziva skoraj 90 % pri bolnikih, pozitivnih na kulture in toksine.
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. 
Kljub omejenemu spektru protibakterijske aktivnosti je bil v poglavje 4.4 vključen navzkrižni sklic s komentarjem o omejenem spektru protibakterijske uporabe in racionalne uporabe.
• Clinical issues 
• Klinični vidiki
• Peritonitis associated with continuous ambulatory peritoneal dialysis (CAPD) There is evidence to suggest that teicoplanin is effective in this indication. 
• Peritonitis, povezan s kontinuirano ambulantno peritonealno dializo (CAPD) Obstajajo dokazi, ki kažejo na učinkovitost teikoplanina pri tej indikaciji.
The spectrum of teicoplanin subcomponents has been better characterised. 
Spekter podkomponent teikoplanina je bil bolje karakteriziran.
The study protocol shall be entered in the EU electronic register of postauthorisation studies (EU PAS Register) before the start of data collection. 
Protokol študije bo vnesen v elektronski register študij o varnosti zdravila po pridobitvi dovoljenja za promet v EU (register EU PAS) pred začetkom zbiranja podatkov.
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. 
Predlagatelj ni predložil podatkov, ki bi dokazovali odsotnost učinka na dojene novorojenčke ali dojenčke; zato je bil stavek „Učinkov na dojene novorojenčke/dojenčke ni pričakovati, saj se teikoplanin ne absorbira peroralno“ izbrisan.
The preclinical safety data reported support these proposed amendments and are provided within the expert report on the toxicological and pharmacological documentation. 
Zabeleženi predklinični varnostni podatki podpirajo predlagane spremembe in so navedeni v strokovnem poročilu o toksikološki in farmakološki dokumentaciji.
Limits for all individual subcomponents were established based on batch data at release and during stability testing. 
Omejitve za vse posamezne podkomponente so bile sprejete na podlagi podatkov serije pri sproščanju in med preskušanjem stabilnosti.
In addition, the CHMP has recommended conditions to the Marketing Authorisation which are set out in Annex IV. 
Poleg tega je priporočil pogoje za dovoljenje za promet z zdravilom, ki so navedeni v Prilogi IV.
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. 
Rezultati izvedenih testov nakazujejo zadovoljivo doslednost in enotnost pomembnih značilnosti kakovosti zdravila, na podlagi česar je mogoče sklepati, da bi zdravila morala izkazati zadovoljivo in enotno delovanje.
The pharmacokinetics of teicoplanin for the treatment of Clostridium difficile was investigated in study DRC342-DLI073. 
Farmakokinetiko teikoplanina za zdravljenje okužbe z bakterijo Clostridium difficile so preučevali v študiji DRC342-DLI073.
Although no pharmacokinetic evidence has been provided, the rationale for having a bolus alternative to the 30-minute infusion to facilitate use in out-patients settings was considered to be acceptable by the CHMP. 
Čeprav niso bili predloženi nobeni farmakokinetični dokazi, je bila utemeljitev za bolusno alternativo 30-minutnemu infundiranju za lajšanje uporabe pri bolnikih v nebolnišničnih okoljih za odbor CHMP sprejemljiva.
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. 
Zaradi različnih nacionalnih odločitev držav članic o odobritvi dovoljenja za promet z zdravilom Targocid in s povezanimi imeni je Evropska komisija obvestila Evropsko agencijo za zdravila o uradni napotitvi v skladu s členom 30 Direktive 2001/83/ES za razrešitev nesoglasij med nacionalnimi povzetki glavnih značilnosti zgoraj navedenih zdravil in s tem uskladitev povzetkov glavnih značilnosti zdravila v Evropski uniji.
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. 
Skupno trajanje zdravljenja s teikoplaninom ni bilo natančno določeno, saj mora biti individualno prilagojeno glede na vrsto in resnost okužbe, klinični odziv bolnika in dejavnike bolnika, kot sta na primer starost in delovanje ledvic.
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. 
Ker se teikoplanin že uporablja pri otrocih v večini držav članic in ker klinične smernice priporočajo njegovo uporabo pri otrocih, je odbor CHMP podprl indikacijo za uporabo teikoplanina pri otrocih, novorojenčkih in dojenčkih.
A Readability Testing was performed and submitted during the referral procedure. 
Izvedli so preverjanje berljivosti in rezultate predložili med napotitvenim postopkom.
The clinical and bacteriological efficacy of teicoplanin was shown in both the European Multicentre Study and in the US open multicentre study. 
Klinična in bakteriološka učinkovitost teikoplanina je bila ugotovljena v evropski multicentrični študiji kot tudi v ameriški odprti multicentrični študiji.
The clinical development focussed on the susceptibility of gram-positive bacteria to teicoplanin and not on specific indications. 
Klinični razvoj se je osredotočal na dovzetnost po Gramu pozitivnih bakterij na teikoplanin in ne na določene indikacije.
Nevertheless a warning has been added in this section that “Teicoplanin should not be administered by intraventricular route”. 
Kljub temu je bilo k temu poglavju dodano obvestilo, da „teikoplanina ni dovoljeno dajati po intraventrikularni poti“.
No new specific reactions due to teicoplanin overdose in the adult population have been identified. 
Zabeležili niso nobenih posebnih reakcij zaradi prevelikega odmerka teikoplanina pri odrasli populaciji.
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. 
Potrebna je bila uskladitev specifikacij zdravilne učinkovine, saj so bile v določenih državah članicah odobrene strožje omejitve za posamezne podkomponente kot v trenutni monografiji Evropske farmakopeje.
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. 
Na podlagi naštetega odbor CHMP meni, da je razmerje med tveganji in koristmi zdravila Targocid in povezanih imen ugodno ter da je mogoče odobriti usklajene dokumente z informacijami o zdravilu.
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. 
Dokumentacija končnega zdravila je bila posodobljena, tako da vključuje študije združljivosti z različnimi vrstami redčil, vrečkami PVC in brizgami, ter podatke o stabilnosti med uporabo.
Adults and elderly patients with impaired renal function The requirement for the adjustment of the dosage in patients with renal impairment, from the fourth day of treatment with teicoplanin has been included. 
Odrasli in starejši bolniki z okvarjenim delovanjem ledvic Vključena je bila zahteva za prilagoditev odmerka pri bolnikih z okvaro ledvic od četrtega dneva zdravljenja s teikoplaninom.
A valid TSE certificate was provided for the active substance. 
Za zdravilno učinkovino je bil izdan veljavni certifikat TSE.
As agreed by the CHMP, the indication for the treatment of bone and joint infections has been maintained without specifically mentioning osteomyelitis, septic arthritis and prosthetic infections. 
Po dogovoru odbora CHMP je bila indikacija za zdravljenje okužb kosti in sklepov ohranjena brez posebne navedbe osteomielitisa, septičnega artritisa in proteznih okužb.
There were also a few cases of endocarditis, respiratory tract infections and urinary tract infections. 
Nekaj je bilo tudi primerov endokarditisa, okužb dihalnih poti in okužb sečil.
In study EG-87-42, the clinical outcome for endocarditis was 83% (excluding patients considered as non-evaluable). 
V študiji EG-87-42 je bil klinični izid za endokarditis 83 % (brez bolnikov, ki jih ni bilo mogoče oceniti).
Teicoplanin antimicrobial activity is thought to depend on trough concentrations being higher than MIC of particular pathogens, and also dependent on the duration of time during which trough concentrations remain higher than MIC. 
Protimikrobno delovanje teikoplanina naj bi bilo odvisno od najmanjših koncentracij, ki so večje od MIK določenih patogenov, pa tudi od časa, pri katerem so najmanjše koncentracije višje od MIK.
4 Reed MD, Yamashita TS, Myers CM, et al. 
Reed MD, Yamashita TS, Myers CM, in sod.
The proposed harmonised SmPC has been updated with additional information on target organs and reproductive toxicity. 
Predlagani usklajeni povzetek glavnih značilnosti zdravila je bil posodobljen z dodatnimi informacijami o ciljnih organih in toksičnosti za razmnoževanje.
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. 
Teikoplanin je kompleksen antibiotik, sestavljen iz šestih tesno povezanih glikopeptidnih podkomponent (A2-1, A2-2, A2-3, A2-4 in A2-5 iz skupine A2 in A3), kot je navedeno v trenutni monografiji Evropske farmakopeje (Ph.
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). 
Imetnik dovoljenja za promet z zdravilom bo Evropski agenciji za zdravila in odboru PRAC predložil protokol študije za oceno v skladu z zahtevami modula VIII GVP (Priloga I).
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. 
Odbor CHMP se je zato strinjal s predlogom imetnika dovoljenja za promet z zdravilom, da je treba teikoplanin uporabljati v kombinaciji z drugimi protimikrobnimi sredstvi, kot je primerno, kar je navedeno v navzkrižnem sklicu v poglavju 4.4.
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. 
Vendar ta indikacija ni priporočena v trenutnih smernicah za zdravljenje infektivnega endokarditisa, kot je izpostavil imetnik dovoljenja za promet z zdravilom, zato se je odbor CHMP strinjal, da se ta indikacija izbriše.
No data in support of the use of teicoplanin in the prevention of infective endocarditis was submitted. 
Predloženi niso bili nobeni podatki v podporo uporabi teikoplanina pri preprečevanju infektivnega endokarditisa.
The indication for the prophylactic use of teicoplanin in orthopaedic surgery was not adequately justified. 
Indikacija profilaktične uporabe teikoplanina v ortopedski kirurgiji ni bila ustrezno utemeljena.
These studies were small and clinical experience with teicoplanin in neonates, infants and children is limited. 
Te študije so bile majhne in klinične izkušnje s teikoplaninom pri novorojenčkih, dojenčkih in otrocih so omejene.
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). 
Izvedeni sta bili dve klinični študiji, in sicer odprti neprimerjalni terapevtski študiji; evropska multicentrična študija (EG-87-42) in ameriška odprta multicentrična študija (N-86-04) ter pregled primerjalnih študij, opravljenih s teikoplaninom (EG-87-35).
Considering all the available information, the CHMP agreed that this indication should remain in the harmonised SmPC. 
Glede na vse razpoložljive podatke se je odbor CHMP strinjal, da mora ta indikacija ostati v usklajenem povzetku glavnih značilnosti zdravila.
Since it is proposed that the loading dose should be administered 3 to 5 times, it has been stated in the SmPC that trough serum concentrations should be monitored on completion of the loading dose regimen. 
Ker je predlagano dajanje polnilnega odmerka od 3- do 5-krat, je bilo v povzetku glavnih značilnosti zdravila navedeno, da je treba najmanjše serumske koncentracije spremljati ob zaključku režima polnilnega odmerka.
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. 
Pri večini bolnikov, ki so bili vključeni v študijo EG-87-42 (ki je bila večja od dveh neprimerjalnih študij), so sumili na po Gramu pozitivne okužbe z različnih mest, večina pa je imela okužbo kože in mehkih tkiv (OKMT), septikemijo ter okužbe kosti in sklepov.
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. 
Nedavne študije časovne mikrobne inhibicije so pokazale, da je bakterijska aktivnost teikoplanina in vitro optimalno preverjena v skladu s smernicami CLSI s toleranco pri 24 urah.
• Skin and soft tissue infections (SSTI) 
• Okužbe kože in mehkih tkiv (OKMT)
Prophylaxis of infections caused by Gram-positive microorganisms Four prophylaxis comparative studies were conducted. 
Profilaksa okužb zaradi po Gramu pozitivnih mikroorganizmov Izvedene so bile štiri primerjalne študije profilaktične uporabe zdravila.
This indication was considered to be acceptable by the CHMP as it appears that teicoplanin is not absorbed to a great extent from the gastro-intestinal tract . 
Ta indikacija je bila za odbor CHMP sprejemljiva, saj se zdi, da se teikoplanin ne absorbira v veliki meri iz prebavnega trakta.
Treatment of infections caused by Gram-positive microorganisms The following infections caused by Gram-positive microorganisms were discussed by the CHMP: 
Zdravljenje okužb zaradi po Gramu pozitivnih mikroorganizmov Odbor CHMP je razpravljal o naslednjih okužbah zaradi po Gramu pozitivnih mikroorganizmov:
Additionally, as mentioned above, the MAH has been requested to perform an appropriate PASS to evaluate the safety of this higher dosage. 
Imetnik dovoljenja za promet z zdravilom je bil prav tako pozvan, kot je navedeno zgoraj, da izvede ustrezno študijo o varnosti zdravila po pridobitvi dovoljenja za promet, da oceni varnost tega višjega odmerka.
• The Committee reviewed the available data on submitted by the MAH from the existing clinical studies, the pharmacovigilance data and the published literature justifying the proposed harmonisation of the SmPC. 
• Odbor je pregledal razpoložljive podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom iz obstoječih kliničnih študij, farmakovigilančnih podatkov in objavljene literature, ki utemeljujejo predlagano uskladitev povzetka glavnih značilnosti zdravila;
Teicoplanin is a glycopeptide antibiotic produced by fermentation of Actinoplanes teichomyceticus with in-vitro bactericidal activity against aerobic and anaerobic gram-positive bacteria. 
Teikoplanin je antibiotik iz skupine glikopeptidov, ki nastane s fermentacijo bakterije Actinoplanes teichomyceticus z bakterijsko aktivnostjo in-vitro proti aerobnim in anaerobnim po Gramu pozitivnim bakterijam.
No specific study has been conducted by the MAH in support of this indication. 
Imetnik dovoljenja za promet z zdravilom ni izvedel nobene posebne študije v podporo tej indikaciji.
The frequencies of all listed adverse reactions have been calculated using data from in-house clinical trials results used for the original submission, and these were incorporated into the CSP during the PSUR work-sharing procedure number GR/H/PSUR/0001/001, which was accepted by the member states. 
Pogostnost vseh navedenih neželenih učinkov je bila izračunana z uporabo podatkov iz rezultatov internih kliničnih preskušanj, uporabljenih za prvotno vlogo, ti pa so bili vključeni v CSP med postopkom za delitev dela PSUR številka GR/H/PSUR/0001/001, kar so države članice sprejele.
In Study EG-87-42, the European multi-centre study, approximately 9% of the subjects enrolled had lower respiratory tract infections. 
V študiji EG-87-42, tj. evropski multicentrični študiji, je imelo približno 9 % vključenih preiskovancev okužbe spodnjih dihalnih poti.
The studies provided in support of prophylactic use in cardiac surgery suggest that teicoplanin was not effective in preventing post-operative infections. 
Študije, predložene v podporo profilaktični uporabi v srčni kirurgiji, nakazujejo, da teikoplanin ni učinkovit pri preprečevanju pooperativnih okužb.
No supportive data for the inclusion of the statement “convulsions after intraventricular administration” was retrieved. 
Pridobljeni niso bili nobeni podporni podatki za vključitev izjave „konvulzije po intraventrikularnem dajanju“.
The loading dose of 12mg/kg bid is in line with what is currently recommended in the SmPCs in France and Finland. 
Polnilni odmerek 12 mg/kg dvakrat na dan je v skladu s trenutnim priporočilom v povzetku glavnih značilnosti zdravila v Franciji in na Finskem.