FrancophonIA/ELRC3.0 huggingface dataset:
English: The effect of the higher loading dose (as proposed in section 4.2) on the possible occurrence of adverse drug reactions has also been addressed by the MAH.
Croatian: Nositelj odobrenja se očitovao i vezano za učinak više početne doze (kako je predloženo u odjeljku 4.2) na moguć nastanak nuspojava kao reakcija na ovaj lijek.
English: Regarding Enterococcus spp., the resistance breakpoint for teicoplanin has been reduced to >2 mg/ml to avoid erroneous reporting of isolates with Van-A-mediated resistance.
Croatian: Što se tiče vrsta roda Enterococcus, prijelomna točka otpornosti za teikoplanin bila je snižena na >2 mg/ml kako bi se izbjeglo pogrešno prijavljivanje izolata s otpornošću koja se temelji na genu Van-A.
English: The MAH has proposed that a trough plasma concentration of 10mg/l (when measured by high performance liquid chromatography) should be maintained for most infections, and that higher concentrations of 15 to 30mg/l for endocarditis, septic arthritis and osteomyelitis should be considered for severe infections.
Croatian: Nositelj odobrenja je predložio da se kod većine infekcija trebaju održavati najniže koncentracije u plazmi od 10 mg/l (mjereno tekućinskom kromatografijom visoke djelotvornosti), a da se kod težih infekcija u slučaju endokarditisa, septičkog artritisa i osteomijelitisa trebaju uzeti u obzir i više koncentracije - 15 do 30 mg/l.
English: The results from the various studies discussed by the MAH suggest that teicoplanin has a place in the management of pneumonia.
Croatian: Rezultati raznih istraživanja o kojima je nositelj odobrenja raspravljao govore u prilog tome da teikoplanin zaslužuje mjesto u obradi upale pluća.
English: 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.
Croatian: PK-PD modelling), predloženo doziranje za djecu temelji se na Monte Carlo simulacijama koje su proveli Lucas i sur. 2004.
English: In conclusion, based on the assessment of the proposals submitted by the MAH and the discussions of the Committee, the CHMP adopted the harmonised product information consisting of the summary of product characteristics (SmPC), labelling and package leaflets, for Targocid and associated names.
Croatian: Da zaključimo - temeljem analize prijedloga koje je predao nositelj odobrenja kao i rasprava ovoga Povjerenstva, CHMP je za Targocid i srodne lijekove prihvatio usklađene informacije o proizvodu koje se sastoje od sažetka opisa svojstava lijeka (SmPC), označavanja i uputa o lijeku.
English: The general format proposed by the MAH is in accordance with the EU guideline on the SmPC and therefore considered to be acceptable by the CHMP.
Croatian: Opći oblik kakvoga je predložio nositelj odobrenja sukladan je smjernici EU o SmPC-ima i stoga ga CHMP smatra prihvatljivim.
English: Indeed, in a Cochrane meta-analysis of randomised controlled trials (RCT) in adults and children with CAPD-associated peritonitis, although the primary response and relapse rates did not differ between intraperitoneal (IP) glycopeptide-based regimens compared to first generation cephalosporin regimens, glycopeptide regimens were more likely to achieve a complete cure, and primary treatment failure was less likely to occur with teicoplanin than vancomycin (Wiggins et al. 2008)1.
Croatian: I doista, u Cochrane metaanalizi randomiziranih kontroliranih ispitivanja (engl. kratica: RCT) kod odraslih osoba i djece oboljelih od peritonitisa povezanog s CAPD-om, iako se stope primarne reakcije i relapsa nisu razlikovale između intraperitonealnih (IP) režima temeljenih na glikopeptidu i režima s cefalosporinom prve generacije, režimi s glikopeptidom češće su dovodili do potpunog izlječenja, a rjeđe je dolazilo do neuspjeha primarnog liječenja teikoplaninom nego vankomicinom (Wiggins i sur. 2008.)1. Uzimajući u obzir sve dostupne informacije, CHMP se usuglasio da ova indikacija treba ostati u usklađenom SmPC-u.
English: The final PL wording was agreed by the CHMP.
Croatian: S konačnim tekstom PL-a usuglasio se i CHMP.
English: The CHMP concluded that teicoplanin should be indicated in complicated SSTIs i.e. severe cases, but not for the treatment of minor SSTIs in line with the British Society for Antimicrobial Chemotherapy (BSAC) guideline, which does not recommend systemic antibiotics for the treatment of minor SSTIs.
Croatian: CHMP je zaključio kako teikoplanin treba biti indiciran kod kompliciranih SSTI-a, drugim riječima, kod težih slučajeva, ali ne i za liječenje blažih SSTI-a, sukladno smjernici Britanskog udruženja za antimikrobnu kemoterapiju (engl.
English: Considering that UTIs are mainly caused by gramnegative infections, the MAH was of the view that teicoplanin has a limited role in the management of UTIs.
Croatian: Budući da UTI-je uglavnom uzrokuju gram-negativne infekcije, stajalište nositelja odobrenja bilo je da u liječenju UTI-ja teikoplanin ima ograničenu ulogu.
English: Based on the Monte Carlo simulations conducted by Yamada et al2 the MAH has proposed a loading dose of 6mg/kg bid for 3 administrations for most infections, and 12mg/kg bid for 3 to 5 administrations for bone and joint infections and infective endocarditis.
Croatian: Temeljem Monte Carlo simulacija koje su proveli Yamada i sur.2 Nositelj odobrenja je za većinu infekcija predložio početnu dozu od 6 mg/kg bid (lat. bis in die - dvaput dnevno) za 3 davanja i 12 mg/kg bid za 3 do 5 davanja kod infekcija kosti i zglobova te infektivnog endokarditisa.
English: Further amendments to the wording of the reproductive toxicity section have been included, as requested by the CHMP.
Croatian: Na zahtjev CHMP-a uključene su daljnje izmjene teksta odjeljka o reproduktivnoj toksičnosti.
English: The information on the measurement of teicoplanin trough serum concentrations by High Performance Liquid Chromatography (HPLC) and Fluorescence Polarization Immunoassay (FPIA) method was considered to be acceptable by the CHMP.
Croatian: CHMP smatra prihvatljivom informaciju o mjerenju najnižih koncentracija teikoplanina u serumu s pomoću Tekućinske kromatografije visoke djelotvornosti (HPLC) i metode Imunološke analize fluorescentnom polarizacijom (engl.
English: Detailed information on the starting materials, fermentation and purification process was provided and found acceptable.
Croatian: Bile su pružene, a i ocijenjene su prihvatljivima, detaljne informacije o početnim materijalima te postupcima fermentacije i pročišćavanja.
English: Potency of teicoplanin active substance is tested according to Ph. Eur.
Croatian: Snaga djelovanja djelatne tvari teikoplanin ispitana je sukladno monografiji Ph.
English: Since this loading dose of 12mg/kg bid (24mg/kg/day) is not well established, a clear statement in section 4.8 has been included in the SmPC that patients should be especially monitored for adverse reactions when higher dosages of 12mg/kg bid (24mg/kg/day) are administered.
Croatian: Budući da početna doza od 12 mg/kg bid (24 mg/kg/dnevno) nije dobro potkrijepljena, u odjeljak 4.8 je u SmPC uključena jasna izjava kako pacijente kojima se daju više doze (12 mg/kg bid = 24 mg/kg/dnevno) treba zbog mogućih nuspojava posebno pratiti.
English: In line with the CHMP Guideline on the Evaluation of Medicinal Products indicated for Treatment of Bacterial Infections (CPMP/EWP/558/95 rev 2), it was considered acceptable to further qualify the indications.
Croatian: Sukladno Smjernici za ocjenjivanje medicinskih proizvoda indiciranih za liječenje bakterijskih infekcija (CPMP/EWP/558/95 rev. 2) Povjerenstva za humane lijekove (engl. kratica: CHMP), smatralo se prihvatljivim indikacije dodatno naznačiti.
English: • Pneumonia and respiratory tract infections
Croatian: • Infekcije dišnih i mokraćnih puteva
English: Treatment of Clostridium difficile infection-associated diarrhoea and colitis In the clinical development program of teicoplanin, three open, non-controlled studies were conducted with teicoplanin IV formulation administered orally for antibiotic-associated diarrhea (AAD) and 1 Wiggins KJ, Cochrane Collaboration review and meta-analysis 2008.
Croatian: Liječenje proljeva i kolitisa povezanih s infekcijom organizmom Clostridium difficile U programu kliničkog razvoja teikoplanina provedena su tri otvorena nekontrolirana istraživanja formulacije teikoplanin IV davane oralno zbog proljeva povezanih s antibioticima (engl. kratica: AAD) te pseudomembranskog kolitisa (engl. kratica: PMC), uzrokovanih organizmom C. difficile.
English: Teicoplanin is a glycopeptide antibiotic produced by fermentation of Actinoplanes teichomyceticus with in-vitro bactericidal activity against aerobic and anaerobic gram-positive bacteria.
Croatian: Sažetak znanstvenog vrednovanja Targocida i srodnih lijekova (vidi Dodatak I) Teikoplanin je glikopeptidni antibiotik koji nastaje fermentacijom vrste Actinoplanes teichomyceticus i pokazuje in-vitro baktericidno djelovanje protiv aerobnih i anaerobnih gram-pozitivnih bakterija.
English: Therefore the indication for the prophylactic use of teicoplanin was not considered to be acceptable by the CHMP.
Croatian: Stoga CHMP nije smatrao da je indikacija teikoplanina za profilaktičku upotrebu prihvatljiva.
English: This PASS is imposed as a condition to the Marketing Authorisation.
Croatian: Ovaj je PASS u Odobrenju za stavljanje lijeka u promet naveden kao uvjet.
English: As is the current practice in some member states, the maintenance dose of 6-12mg/kg od depending on the type of infection was maintained: 6mg/kg od for complicated skin, soft tissue and urinary tract infections and pneumonia and 12mg/kg od for bone and joint infections and endocarditis.
Croatian: Kao što je trenutna praksa u nekim državama članicama, doza održavanja od 6 - 12 mg/kg jednom dnevno, ovisno o vrsti infekcije, daje se kako slijedi: 6 mg/kg jednom dnevno kod kompliciranih infekcija kože, mekoga tkiva i mokraćnih puteva te kod upale pluća, a 12 mg/kg jednom dnevno kod infekcija kosti i zglobova te kod endokarditisa.
English: This information has been proposed by the MAH in the harmonised SmPC and was considered to be acceptable by the CHMP.
Croatian: Ovu je informaciju u usklađenom SmPC-u bio predložio nositelj odobrenja, a CHMP ju je smatrao prihvatljivom.
English: Section 4.7 - Effects on ability to drive and use machines The wording of the CSP agreed during the PSUR work-sharing procedure (GR/H/PSUR/0001/001) was considered to be acceptable by the CHMP.
Croatian: Odjeljak 4.7. - Utjecaj na sposobnost upravljanja vozilima i strojevima CHMP je smatrao prihvatljivim tekst CSP-a koji je usuglašen tijekom postupka za podjelu posla PSUR-a (GR/H/PSUR/0001/001).
English: A warning has been included in sections 4.4 and 4.8 of the SmPC that patients should be especially monitored for adverse reactions when the higher dosage of 12mg/kg bid is administered.
Croatian: odjeljcima 4.4 i 4.8 navedena su upozorenja iz SmPC-a koja govore kako pacijente kojima se daju više doze (12 mg/kg bid) treba zbog mogućih nuspojava posebno pratiti.
English: The proposed harmonised SmPC reflecting the changes was considered to be acceptable by the CHMP.
Croatian: CHMP je predloženi usklađeni SmPC koji odražava ove promjene smatrao prihvatljivim.
English: In Study EG-87-42 (European Multicentre Study), the clinical and bacteriological efficacy of teicoplanin has been shown in UTI (8% of all infection sites).
Croatian: U Europskom multicentralnom istraživanju EG-87-42 kod UTI-ja (8% svih mjesta infekcija) pokazala se klinička i bakteriološka učinkovitost teikoplanina.
English: • The Committee agreed the harmonisation of the summary of product characteristic, labelling and package leaflet proposed by the marketing authorisation holder.
Croatian: • Ovo se Povjerenstvo usuglasilo s usklađenjem sažetka opisa svojstava lijeka, označavanja i uputa o lijeku kako ih je predložio nositelj odobrenja za stavljanje lijeka u promet.
English: No supportive data for the inclusion of the statement “convulsions after intraventricular administration” was retrieved.
Croatian: Za uključivanje izraza "konvulzije nakon intraventrikularnog davanja" nisu dobiveni potkrepljujući podaci.
English: In the paediatric population, an adverse reaction was not reported most cases of teicoplanin overdose;
Croatian: U pedijatrijskoj populaciji u većini slučajeva predoziranja teikoplaninom nuspojave nisu zabilježene.
English: A statement regarding the absence of specific interaction studies has been added to the SmPC by the MAH and agreed by the CHMP.
Croatian: Nositelj odobrenja je u SmPC dodao izjavu koja se tiče nepostojanja istraživanja specifičnih interakcija, a CHMP se s time složio.
English: • Peritonitis associated with continuous ambulatory peritoneal dialysis (CAPD) There is evidence to suggest that teicoplanin is effective in this indication.
Croatian: • Peritonitis povezan s kontinuiranom ambulantnom peritonealnom dijalizom (engl. kratica: CAPD)
English: A modified warning regarding hypersensitivity reactions to address the fatal cases that have been reported and to strengthen the possibility of cross hypersensitivity to vancomycin was proposed by the MAH, and accepted by the CHMP.
Croatian: Nositelj odobrenja je predložio, a CHMP prihvatio, izmijenjeno upozorenje koje se tiče reakcija preosjetljivosti, zbog zabilježenih fatalnih slučajeva i kako bi se ojačala mogućnost unakrsne preosjetljivosti na vankomicin.
English: Peptidoglycan synthesis is blocked by specific binding to D-alanyl-D-alanine residues.
Croatian: Specifičnim vezanjem na ostatke D-alanil-D-alanin blokira se sinteza peptidoglikana.
English: Prophylaxis of infections caused by Gram-positive microorganisms Four prophylaxis comparative studies were conducted.
Croatian: Profilaksa infekcija uzrokovanih gram-pozitivnim mikroorganizmima
English: 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).
Croatian: US Open Multicentre Study) (N-86-04) kao i pregled usporednih istraživanja provedenih s teikoplaninom (EG-87-35).
English: A valid TSE certificate was provided for the active substance.
Croatian: Za djelatnu je tvar bio osiguran valjani TSE certifikat.
English: • Urinary tract infections (UTI)
Croatian: • Infekcije mokraćnih puteva (engl. kratica: UTI)
English: • Bone and joint infections
Croatian: • Infekcije kosti i zglobova
English: 3 Lucas JC, Karikas G, Gazouli M, et al. Pharmacokinetics of teicoplanin in an ICU population of children and infants.
Croatian: 3 Lucas JC, Karikas G, Gazouli M i sur.
English: 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.
Croatian: Ipak, nekoliko je slučajeva endokarditisa bilo uključeno u otvorena istraživanja (EG-87-42 i N-86-04) koja su bila provedena kao podrška inicijalnom odobrenju za stavljanje lijeka u promet. u istraživanju EG-8742, klinički je ishod kod endokarditisa bio 83% (nakon isključivanja pacijenata koje se smatralo nepogodnima za ovo ocjenjivanje).
English: Section 4.5- Interaction with other medicinal products and other forms of interaction The lack of interaction between teicoplanin and other antibiotics, antihypertensives, cardiotropic, antidiabetic agents and anaesthetic agents has been included in the proposed harmonised SmPC.
Croatian: U predloženom usklađenom SmPC-u isključeno je postojanje interakcija između teikoplanina i drugih antibiotika, antihipertenziva, kardiotropnih, antidijabetičkih sredstava te anestetičkih sredstava.
English: 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).
Croatian: Nositelj odobrenja mora protokol ovoga istraživanja predati na ocjenu Europskoj agenciji za lijekove i Povjerenstvu za procjenu rizika na području farmakovigilancije (engl. kratica: PRAC), sukladno propisima modula VIII (Dopuna I) Dobre farmakovigilancijske prakse (engl. kratica: GVP).
English: Section 4.6 - Fertility, pregnancy and lactation The MAH has aligned the text so that it is in line with the CSP and the CHMP Guideline on risk assessment of medicinal products on human reproduction and lactation: From Data to labelling (EMEA/CHMP/203927/2005).
Croatian: Nositelj odobrenja je ispravio tekst tako da bude usklađen sa CSP-om i smjernicom CHMP-a o procjeni rizika medicinskih proizvoda po ljudsku reprodukciju i dojenje: Od podataka do označavanja (engl.
English: The MAH took the opportunity to harmonise the Quality dossier for Targocid and associated names as part of the referral procedure.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet, iskoristio je u sklopu postupka upućivanja priliku za usklađivanje Dosjea o kvaliteti za Targocid i srodne lijekove.
English: Linearity of the pharmacokinetics as well as a statement addressing special populations has also been included, in line with the above mentioned EU guideline.
Croatian: Sukladno gore spomenutoj smjernici EU-a, bili su uključeni podaci linearne farmakokinetike kao i izjava koja se odnosi na posebne populacije. odjeljak 5.3 - Pretklinički podaci o sigurnosti
English: Since safety data for the loading dose of12mg/kg bid (24mg/kg/day) is limited, the MAH has been requested by the CHMP to conduct a post-authorisation safety study (PASS) to evaluate the safety of the higher loading dose of 12mg/kg bid.
Croatian: Sigurnosno istraživanje nakon izdavanja odobrenja (PASS) Budući da su sigurnosni podaci koji se tiču početnih doza od 12 mg/kg bid (24 mg/kg/dnevno) ograničeni, CHMP je od nositelja odobrenja tražio da provede sigurnosno istraživanje nakon izdavanja odobrenja (PASS) kojim bi se ocijenila sigurnost više početne doze (12 mg/kg bid = 24 mg/kg/dnevno).
English: In addition, the CHMP has recommended conditions to the Marketing Authorisation which are set out in Annex IV.
Croatian: Odobrenja za stavljanje lijeka u promet kakvi su zadani u Dodatku IV.
English: All the important safety information that has been included in the SmPC has been listed in order of importance: hypersensitivity reactions, infusion related reactions (Red Man Syndrome), severe bullous reactions (including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN)), warning concerning the possible adverse reactions with the higher loading dose of 12mg/kg bid
Croatian: Red Man Syndrome), teške bulozne reakcije (uključujući i Stevens-Johnsonov Sindrom (SJS) i toksičnu epidermalnu nekrolizu (TEN)), upozorenje zbog mogućih nuspojava kod viših početnih doza (12 mg/kg bid = 24 mg/kg/dnevno), trombocitopenija, nefrotoksičnost, ototoksičnost i superinfekcija.
English: the CHMP has recommended the variation to the terms of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Targocid and associated names (see Annex I).
Croatian: CHMP je za Targocid i srodne lijekove (vidi Dodatak I) preporučio promjene uvjeta odobrenja za stavljanje lijeka u promet, za koje su odobrenje sažetak opisa svojstava lijeka, označavanje i uputa o lijeku zadani u Dodatku III.
English: Section 4.4 - Special warnings and precautions for use The wording of the core safety profile (CSP), currently approved in the context of the PSUR worksharing procedure number GR/H/PSUR/0001/001, was proposed by the MAH for the harmonised SmPC.
Croatian: Odjeljak 4.4 - Posebna upozorenja i mjere opreza pri upotrebi Nositelj odobrenja je za usklađeni SmPC predložio tekst temeljnog sigurnosnog profila (engl. core safety profile; kratica:CSP), kakav je trenutno odobren u kontekstu postupka za podjelu posla Periodičkog izvješća o neškodljivosti lijeka (engl.
English: The wording of the CSP agreed during the PSUR work-sharing procedure (number GR/H/PSUR/0001/001) was considered to be acceptable by the CHMP.
Croatian: PSUR work-sharing procedure) broj GR/H/PSUR/0001/001.
English: Other studies were also discussed by the MAH.
Croatian: Nositelj odobrenja je raspravljao i o drugim istraživanjima.
English: Information on the active substance was submitted in an ASMF.
Croatian: Informacija o djelatnoj tvari bila je priložena u Glavnoj dokumentaciji o djelatnoj tvari (engl.
English: Since safety data for the loading dose of 12mg/kg bid (24mg/kg/day) is limited, the MAH has agreed to the request made by the CHMP to perform an appropriate post authorisation safety study (PASS) to evaluate the safety of the higher loading dose of 12mg/kg bid (24mg/kg/day).
Croatian: Budući da su sigurnosni podaci koji se tiču početnih doza od 12 mg/kg bid (24 mg/kg/dnevno) ograničeni, nositelj odobrenja se usuglasio sa zahtjevom CHMP-a za provođenjem odgovarajućeg naknadnog sigurnosnog istraživanja nakon izdavanja odobrenja (engl. post authorisation safety study; kratica: PASS) kojim bi se ocijenila sigurnost više početne doze (12 mg/kg bid = 24 mg/kg/dnevno). nositelj odobrenja se isto tako usuglasio sa zahtjevom CHMP-a prema kojemu nositelj odobrenja mora priložiti plan upravljana rizicima (u kojega će biti uključen i protokol PASS-a), a koji bi osobito trebao kvalitetno obraditi važne moguće rizike povećane učestalosti nefrotoksičnosti i drugih teških nuspojava kod početnih doza od 12 mg/kg bid (24 mg/kg/dnevno).
English: Section 4.2 - Posology and method of administration Posology
Croatian: Odjeljak 4.2 - Doziranje i način primjene
English: Package Leaflet (PL)
Croatian: Uputa o lijeku (engl. kratica: PL)
English: The subcomponents are separated by HPLC according to their polarity.
Croatian: Ove se potkomponente odvajaju na osnovu njihove polarnosti s pomoću tekućinske kromatografije visoke djelotvornosti (engl. kratica: HPLC).
English: monograph.
Croatian: Doziranje
English: • problems with speech
Croatian: • problem s govorom
English: What INVEGA is and what it is used for
Croatian: Što je INVEGA i za što se koristi
English: Weight should be monitored regularly.
Croatian: Težina se mora redovito kontrolirati.
English: All tablets are available in the following pack sizes:
Croatian: Sve tablete dostupne su u pakiranjima sljedećih veličina:
English: Initial dose titration is not required.
Croatian: Titracija početne doze nije potrebna.
English: Your doctor should regularly measure your body weight.
Croatian: Liječnik vam redovito treba mjeriti tjelesnu težinu.
English: This should be considered in cases where full alertness is required, e.g., when driving a car or handling machines.
Croatian: To se treba uzeti u obzir u slučajevima kada je potrebna potpuna pozornost, npr. pri vožnji automobila ili upravljanju strojevima.
English: Currently available data are described in section 4.8 and 5.1 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelu 4.8 i 5.1, ali se preporuka za doziranje ne može dati.
English: If you miss two or more doses, contact your doctor.
Croatian: Ako propustite dvije ili više doza, javite se svom liječniku.
English: Significant weight gain may adversely affect your health.
Croatian: Značajno povećanje težine može štetno djelovati na vaše zdravlje.
English: This effect was not observed after discontinuation of treatment.
Croatian: Ovaj učinak nije bio zapažen nakon prekida liječenja.
English: Dosing was in the morning without regard to meals.
Croatian: Doziranje je bilo ujutro bez obzira na jelo.
English: The difference is unlikely to be of clinical relevance, though.
Croatian: Međutim, ta razlika vjerojatno nije klinički relevantna.
English: IFIS may increase the risk of eye complications during and after the operation.
Croatian: IFIS može povećati rizik za nastanak komplikacija oka tijekom i nakon opreacije.
English: This medicine should be taken every morning with breakfast or without breakfast, but in the same way every day.
Croatian: Ovaj lijek se uzima svako jutro uz doručak ili bez doručka (natašte), i to na isti način svakoga dana.
English: There was no clear dose relationship.
Croatian: Nije bilo jasne uzročne povezanosti.