FrancophonIA/ELRC3.0 huggingface dataset:
English: The preclinical safety data reported support these proposed amendments and are provided within the expert report on the toxicological and pharmacological documentation.
Croatian: Objavljeni pretklinički sigurnosni podaci podržavaju ove predložene promjene i uključeni su u izvješće stručnjaka o toksikološkoj i farmakološkoj dokumentaciji.
English: A Readability Testing was performed and submitted during the referral procedure.
Croatian: Ispitivanje čitljivosti je provedeno i priloženo tijekom postupka upućivanja.
English: Following all the changes in the SPC there are several corresponding changes to the Package Leaflet.
Croatian: Zbog svih promjena u SPC-u, nekoliko se odgovarajućih promjena nalazi i u Uputi o lijeku.
English: Treatment of infections caused by Gram-positive microorganisms The following infections caused by Gram-positive microorganisms were discussed by the CHMP:
Croatian: Liječenje infekcija uzrokovanih gram-pozitivnim mikroorganizmima CHMP je raspravljao o sljedećim infekcijama uzrokovanima gram-pozitivnim mikroorganizmima:
English: 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.
Croatian: Stoga se CHMP bio složio s prijedlogom nositelja odobrenja da se teikoplanin treba upotrebljavati u kombinaciji s drugim antimikrobnim sredstvima kada je to prikladno, kao što se unakrsno referira u odjeljku 4.4.
English: 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.
Croatian: Ovo je kompleksni antibiotik koji se sastoji od šest blisko srodnih glikopeptidnih potkomponenata (A2-1, A2-2, A2-3, A2-4 i A2-5 - koji čine skupinu A2 te potkomponente A3), kako je definirano u monografiji teikoplanina u aktualnoj Europskoj farmakopeji (Ph. Eur.).
English: 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.
Croatian: Učinkovitost teikoplanina u liječenju gram-pozitivnih infekcija bila je istraživana u mnogim kliničkim ispitivanjima koja su u inicijalnom odobrenju predočena zajedno s referencama na izvore.
English: The MAH has amended section 4.3 only including hypersensitivity to teicoplanin (or to any of the excipients).
Croatian: Nositelj odobrenja je odjeljak 4.3 izmijenio samo dodavanjem preosjetljivosti na teikoplanin (ili neku od pomoćnih tvari).
English: 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.
Croatian: Rezultati iz ova tri istraživanja pokazala su kako je teikoplanin kod pacijenata pozitivnih na kulturu i toksine postigao ukupnu stopu kliničke i bakteriološke reakcije od gotovo 90%.
English: 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.
Croatian: Budući da je predloženo da se početne doze trebaju davati 3 do 5 puta, u SmPC-u je izneseno kako se nakon dovršetka režima početnih doza moraju pratiti najniže koncentracije u serumu.
English: The clinical and bacteriological efficacy of teicoplanin was shown in both the European Multicentre Study and in the US open multicentre study.
Croatian: Klinička i bakteriološka učinkovitost teikoplanina dokazana je i u Europskom multicentralnom istraživanju i u Američkom otvorenom multicentralnom istraživanju.
English: 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.
Croatian: No ova se indikacija ne preporuča u aktualnim smjernicama o obradi infektivnog endokarditisa, kao što je istaknuo nositelj odobrenja, pa je stoga CHMP brisanje ove indikacije smatrao prihvatljivim.
English: Section 4.1 - Therapeutic Indications
Croatian: Odjeljak 4.1 - Terapijske indikacije
English: 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.
Croatian: Odrasli i stariji pacijenti s narušenom bubrežnom funkcijom Uključeni su i zahtjevi za prilagodbom doziranja od četvrtog dana liječenja teikoplaninom kod pacijenata s bubrežnim poremećajem.
English: The proposed harmonised SmPC has been updated with additional information on target organs and reproductive toxicity.
Croatian: Predloženi usklađeni SmPC bio je ažuriran dodatnim informacijama o reproduktivnoj i toksičnosti za ciljne organe.
English: monograph for microbiological assay of antibiotics.
Croatian: Eur. za mikrobiološka ispitivanja antibiotika.
English: 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.
Croatian: Kao što se CHMP usuglasio, indikacija za liječenje infekcija kosti i zglobova bila je podržana bez specifičnog navođenja osteomijelitisa, septičkog artritisa i prostetičkih infekcija.
English: 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.
Croatian: Ukupno trajanje liječenja teikoplaninom nije precizno zadano jer se ono treba prilagoditi od slučaja do slučaja, sukladno vrsti i težini infekcije koju se liječi, kliničkoj reakciji pacijenta te podataka o pacijentu poput njihove renalne funkcije i starosti.
English: The indication for the prophylactic use of teicoplanin in orthopaedic surgery was not adequately justified.
Croatian: Indikacija profilaktičke upotrebe teikoplanina u ortopedskoj kirurgiji nije bila odgovarajuće opravdana.
English: • 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.
Croatian: • Ovo Povjerenstvo razmotrilo otkrivene divergencije u informacijama o proizvodu za Targocid i srodne lijekove, u odjeljcima koji se tiču terapijskih indikacija, doziranja i metoda davanja, kontraindikacija te posebnih upozorenja i mjera opreza pri upotrebi, kao i preostale odjeljke SmPC-a.
English: 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.
Croatian: Većina je pacijenata uključenih u istraživanje EG87-42 (a ono je veće od dva spomenuta neusporedna istraživanja) nosila sumnju na gram-pozitivne infekcije na raznim mjestima, pri čemu je većina njih patila od infekcija kože i mekih tkiva (engl. kratica: SSTI), septikemije i infekcija kosti i zglobova.
English: The clinical and bacteriological efficacy of teicoplanin was shown in SSTIs (37.4% of all infection sites) in Study EG-87-42 (European Multicentre Study).
Croatian: Klinička i bakteriološka učinkovitost teikoplanina kod SSTI-a (37,4% svih mjesta infekcije) dokazana je u Europskom multicentralnom istraživanju EG-87-42.
English: There were also a few cases of endocarditis, respiratory tract infections and urinary tract infections.
Croatian: Pored toga bilo je nekoliko slučajeva endokarditisa te infekcija dišnih i mokraćnih puteva.
English: • 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.
Croatian: • Ovo je Povjerenstvo pregledalo dostupne podatke koje je predao nositelj odobrenja, a koji se tiču postojećih kliničkih ispitivanja, zatim podatke o farmakovigilanciji i objavljenu literaturu koja podržava predloženo usklađivanje SmPC-a.
English: 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.
Croatian: Usklađivanje odjeljka s farmakokinetičkim podacima SmPC-a teikoplanina temelji se na podacima koji su dani isprva, u inicijalnom zahtjevu za odobrenje za stavljanje lijeka u promet, kao i na novijim podacima dobivenima pretragom literature.
English: Regarding dental surgery prophylaxis, the results suggested that teicoplanin could be useful.
Croatian: Što se tiče profilakse kod dentalne kirurgije, rezultati su nalagali da bi teikoplanin mogao biti koristan.
English: 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 .
Croatian: Ovu je indikaciju CHMP smatrao prihvatljivom jer izgleda da se teikoplanin ne apsorbira iz probavnog trakta u velikoj mjeri.
English: Section 5.2 - Pharmacokinetic properties
Croatian: Odjeljak 5.2 - Farmakokinetička svojstva
English: No data in support of the use of teicoplanin in the prevention of infective endocarditis was submitted.
Croatian: Nisu bili priloženi nikakvi podaci koji bi potkrijepili upotrebu teikoplanina u prevenciji infektivnog endokarditisa.
English: These studies were small and clinical experience with teicoplanin in neonates, infants and children is limited.
Croatian: Ova su istraživanja bila malena, a kliničko je iskustvo s teikoplaninom kod novorođenčadi te mlađe i starije djece ograničeno.
English: 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.
Croatian: Mikrobiološki spektar teikoplanina pokriva vrste staphylococci uključujući Staphylococcus aureus, bilo osjetljiv ili otporan na meticilin, Streptococcus pneumoniae i ostale streptococci koji uglavnom uključuju Streptococcus pyogenes, streptococci iz skupine Viridans te Enterococcus faecalis.
English: In all (pooled data), 72 episodes of infection were treated in 71 adult patients.
Croatian: Skupni podaci iz sva tri istraživanja govore kako su kod 71 odraslog pacijenta liječene 72 epizode infekcije.
English: The harmonised dossier was provided for the active substance (teicoplanin) and for products containing this substance: Targocid 100, 200 mg and 400 mg powder for solution for injection/infusion and Targocid 100, 200 mg and 400 mg powder and solvent for solution for injection/infusion.
Croatian: Usklađeni dosje bio je predan za djelatnu tvar (teikoplanin) i za proizvode koji ovu tvar sadržavaju: Targocid 100, 200 mg i 400 mg prašak za otopinu za injekciju/infuziju i Targocid 100, 200 mg i 400 mg prašak i otapalo za injekciju/infuziju.
English: Limits for all individual subcomponents were established based on batch data at release and during stability testing.
Croatian: Ograničenja za sve pojedine potkomponente određena su temeljem skupnih podataka pri stavljanju lijeka u promet i tijekom ispitivanja stabilnosti.
English: The indication was therefore restricted to complicated urinary tract infections, which was accepted by the CHMP.
Croatian: Stoga je indikacija bila ograničena na komplicirane infekcije mokraćnih puteva, a CHMP je to bio prihvatio.
English: In accordance with the CHMP guideline and the SmPC Guideline, the applicant has also inserted information with regard to fertility.
Croatian: Sukladno smjernici CHMP-a i smjernici o SmPC-u, podnositelj je ujedno umetnuo informaciju koja se tiče plodnosti.
English: The studies provided in support of prophylactic use in cardiac surgery suggest that teicoplanin was not effective in preventing post-operative infections.
Croatian: Istraživanja navedena kao podrška profilaktičkoj upotrebi u kardiokirurgiji nalažu kako teikoplanin nije bio učinkovit u sprječavanju postoperativnih infekcija.
English: In Study EG-87-42, the European multi-centre study, approximately 9% of the subjects enrolled had lower respiratory tract infections.
Croatian: U Europskom multicentralnom istraživanju EG-87-42 približno je 9% uključenih ispitanika patilo od infekcija donjih dišnih puteva.
English: The proposed wording was considered to be acceptable by the CHMP.
Croatian: CHMP je predloženi tekst smatrao prihvatljivim.
English: The product information was therefore updated to declare the qualitative and quantitative details of the active substance in terms of mass and IU: each vial contains 200mg (or 400) mg teicoplanin equivalent to 200,000 IU (or 400,000 IU).
Croatian: Stoga je informacija o ovom proizvodu bila ažurirana kako bi izražavala kvalitativne i kvantitativne detalje o djelatnoj tvari u vrijednostima mase i IU: svaka bočica sadržava 200 mg (ili 400) mg teikoplanina što je ekvivalentno 200.000 IU (ili 400.000 IU).
English: 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.
Croatian: Temeljem gornjega, CHMP smatra kako je omjer prednosti i rizika Targocida i srodnih lijekova povoljan te da se usklađeni dokumenti Informacija o proizvodu mogu odobriti.
English: 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.
Croatian: Smatra se kako antimikrobno djelovanje teikoplanina ovisi o tome da najniže koncentracije budu više od minimalne inhibicijske koncentracije (engl. kratica: MIC) određenih patogena te da isto tako ovisi o vremenu u kojemu najniže koncentracije ostaju više od MIC-a.
English: Teicoplanin inhibits the growth of susceptible organisms by interfering with cell-wall biosynthesis at a site different from that affected by beta-lactam antibiotics.
Croatian: Teikoplanin inhibira rast organizama osjetljivih na ovaj antibiotik djelujući na biosintezu staničnih stjenki na mjestu koje se razlikuje od onoga na koje djeluju beta-laktamski antibiotici.
English: 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.
Croatian: Zato je izbrisana rečenica „Ne očekuju se nikakvi utjecaju na dojenu novorođenčad/djecu jer se teikoplanin ne apsorbira oralno”.
English: 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.
Croatian: Novija "time-kill" istraživanja potvrđuju kako se in vitro baktericidno djelovanje teikoplanina optimalno ispituje sukladno smjernicama Instituta za kliničke i laboratorijske standarde (engl. kratica: CLSI), uz toleranciju postavljenu na 24 sata.
English: 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.
Croatian: Iako za to nisu pruženi nikakvi farmakokinetički dokazi, CHMP je prihvatio logičnost davanja bolusa kao alternative 30-minutnoj infuziji s ciljem pojednostavljenja upotrebe ovoga lijeka kod ambulantnih bolesnika.
English: The MAH has provided evidence from publications in support of the use of teicoplanin in combination with other anti-microbial agents such as aminoglycosides.
Croatian: Nositelj odobrenja je pružio dokaze iz literature koji podržavaju upotrebu teikoplanina u kombinaciji s drugim antimikrobnim sredstvima poput aminoglikozida.
English: 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.
Croatian: Što se tiče interakcija s teikoplaninom, poznato je da se zbog mogućnosti pojačanih nuspojava pacijentima koji istovremeno primaju i nefrotoksične ili ototoksične lijekove kao što su aminoglikozidi, amfotericin B, ciklosporin i furosemid, teikoplanin mora davati oprezno.
English: For coagulase-negative staphylococci (CoNS), the resistance breakpoint is >4 mg/ml.
Croatian: Prijelomna točka otpornosti za na koagulazu negativne staphylococci (engl. kratica: CoNS) iznosi >4 mg/ml.
English: No new specific reactions due to teicoplanin overdose in the adult population have been identified.
Croatian: Kod odraslih osoba nisu otkrivene nikakve nove specifične reakcije zbog predoziranja teikoplaninom.
English: 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.
Croatian: Učestalosti svih navedenih nuspojava izračunate su s pomoću podataka iz rezultata internih kliničkih ispitivanja navedenih pri prvotnom podnošenju zahtjeva, a uključene su u CSP tijekom postupka za podjelu posla PSUR-a pod brojem GR/H/PSUR/0001/001, koji su bile prihvatile države članice.
English: Overall, the undesirable effects listed in the CSP agreed during the PSUR work-sharing procedure number GR/H/PSUR/0001/001 have been included in section 4.8 of the proposed harmonised SmPC using the MedDRA Preferred Terms (PTs), and classified by System Organ Class (SOC).
Croatian: Općenito, nuspojave navedene u CSP-u, usuglašene tijekom postupka za podjelu posla PSUR-a pod brojem GR/H/PSUR/0001/001, bile su uključene u odjeljak 4.8 predloženog usklađenog SmPC-a pri čemu se upotrebljavala Preferirana terminologija MedDRA-e, a ove su nuspojave klasificirane s pomoću Razreda organskog sustava (engl.
English: The CHMP agreed that teicoplanin can be indicated for the treatment of pneumonia (hospital acquired and community acquired pneumonia) without restricting its use according to the pathogen.
Croatian: CHMP se usuglasio da se teikoplanin može indicirati za liječenje upale pluća (kako hospitalne, tako i one kojom se pacijenti zaraze drugdje), a da se njegova upotreba ne ograničava na određeni patogen.
English: The CHMP has requested the MAH to submit a RMP within 6 months of the Commission Decision to adequately address the important potential risks, in particular, the increased frequency of nephrotoxicity and other serious reactions with loading doses of 12mg/kg bid (24mg/kg/day).
Croatian: CHMP je zatražio od nositelja odobrenja da preda RMP unutar 6 mjeseci od Odluke povjerenstva, kako bi se odgovarajuće obradili važni mogući rizici, osobito povećana učestalost nefrotoksičnosti i drugih teških reakcija kod početnih doza od 12 mg/kg bid (24 mg/kg/dnevno).
English: No specific study has been conducted by the MAH in support of this indication.
Croatian: Nositelj odobrenja nije proveo nikakva specifična istraživanja koja bi potkrijepila ovu indikaciju.
English: In the four published studies of the initial dossier, the teicoplanin dose regimens across studies ranged from 6 mg/kg unit dose to a loading dose of 10 mg/kg every 12 hours for 3 doses followed by 10 mg/kg daily maintenance dose.
Croatian: U četiri objavljena istraživanja navedena u inicijalnom dosjeu režimi doziranja teikoplanina kroz ta su istraživanja bili u rasponu od jedinične doze (6 mg/kg) do početne doze (10 mg/kg), svakih 12 sati za 3 doze, nakon čega je slijedila dnevna doza održavanja od 10 mg/kg.
English: In the current version of EUCAST MIC breakpoints, the resistance breakpoint for Staphylococcus aureus has been reduced to >2 mg/ml to avoid reporting of glycopeptide intermediate resistant Staphylococcus aureus (GISA) isolates, as serious infections with GISA isolates are not treatable with increased doses of vancomycin or teicoplanin.
Croatian: U aktualnoj verziji EUCAST-ovih prijelomnih točaka MIC-a, prijelomna točka otpornosti za vrstu Staphylococcus aureus bila je smanjena na >2 mg/ml kako bi se izbjeglo prijavljivanje izolata vrste Staphylococcus aureus otporne na glikopeptidni intermedijer (engl. kratica: GISA), jer se teške infekcije izolatima GISA-e ne mogu liječiti povišenim dozama vankomicina ni teikoplanina.
English: The antibacterial spectrum has been updated in accordance with the CHMP Note for Guidance on Evaluation of Medicinal Products Indicated for Treatment of Bacterial Infections (CHMP/EWP/588/95 rev 2).
Croatian: Antibakterijski spektar je bio ažuriran sukladno Obavijesti CHMP-a o smjernici za ocjenjivanje medicinskih proizvoda indiciranih za liječenje bakterijskih infekcija (CPMP/EWP/588/95 rev. 2).
English: No pharmacokinetic drug-drug interaction with teicoplanin has been carried out by the MAH, and no published data have been retrieved from the literature.
Croatian: Nositelj odobrenja nije naveo nikakve farmakokinetičke interakcije između teikoplanina i nekog drugog lijeka, a nisu ni prikupljeni podaci iz literature.
English: The strengths of teicoplanin finished product are conventionally declared and prescribed in terms of mass (e.g. 200 mg and 400 mg), but given the variability of the active substance, it is the potency of the finished product, as determined by microbiological assay and declared in IU (e.g. 200,000 IU or 400,000 IU), that determines the quantitative amount of active substance in the finished product.
Croatian: Jačine gotovih proizvoda s teikoplaninom izražene su na konvencionalan način i navedene u vrijednostima mase (npr. 200 mg i 400 mg), no s obzirom na varijabilnost djelatne tvari, kvantitativnu količinu djelatne tvari u gotovom proizvodu određuje snaga gotovog proizvoda kako je određena mikrobiološkom analizom i izražena u IU (npr. 200.000 IU ili 400.000 IU).
English: Section 5.1 - Pharmacodynamic properties
Croatian: Odjeljak 5.1 - Farmakodinamička svojstva
English: However the available data suggest that teicoplanin administered IV or IM at dosages of 10 mg/kg every 12 hours for 1 to 5 doses (loading dosage), then 6 to 10 mg/kg once daily, is effective in the treatment of Gram-positive infections such as septicaemia, skin and soft tissue infections, bone and joint infections, lower respiratory tract infections, and in neutropenia and fever, in children.
Croatian: Ipak, dostupni podaci nalažu kako je teikoplanin - kada se daje IV ili IM u dozama od 10 mg/kg svakih 12 sati (od 1 do 5 doza - početne doze), a zatim 6 do 10 mg/kg jednom dnevno - kod djece učinkovit u liječenju grampozitivnih infekcija poput septikemije, infekcija kože i mekih tkiva, infekcija kosti i zglobova, infekcija donjih dišnih puteva te neutropenije i vrućice.
English: 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.
Croatian: Zbog divergentnih odluka koje su pojedine države članice donijele vezano za odobrenje Targocida i srodnih lijekova, Europsko povjerenstvo obavijestilo je Europsku agenciju za lijekove (engl. kratica: EMA) o službenoj uputi sukladno Članku 30 Direktive 2001/83/EC s ciljem rješavanja divergentnosti Sažetaka opisa svojstava lijeka (engl.
English: The spectrum of teicoplanin subcomponents has been better characterised.
Croatian: Bolje je opisan spektar potkomponenata teikoplanina.