natgillin/translations-raw huggingface dataset:
It is intended to be applied to the surface of permanent teeth in four weekly applications in the first month of treatment, followed by a single application at month six. 
Zdravilo se nanaša na površino trajnih zob vsake štiri tedne v prvem mesecu zdravljenja in nato še enkrat v šestem mesecu.
Overall summary of the scientific evaluation of Prevora 
Splošni povzetek znanstvenega vrednotenja zdravila Prevora
Therefore, when considered in addition to the previously submitted data, there is now sufficient evidence to conclude that the risk-benefit is positive in the proposed indication. 
Zato je zdaj ob upoštevanju predhodno predloženih podatkov dovolj dokazov za zaključek, da je razmerje med koristmi in tveganji za predlagano indikacijo pozitivno.
The two clinical studies initially submitted by the MAH to support the proposed indication were: 
Klinični študiji, ki ju je imetnik dovoljenja za promet z zdravilom prvotno predložil za podporo predlagani indikaciji, sta bili:
The MAH, CHX Technologies Europe Ltd submitted to CHMP for consideration the results of another study, the Prevention of Adult Caries Study (PACS), to confirm the results seen to date. 
Imetnik dovoljenja za promet z zdravilom, družba CHX Technologies Europe Ltd, je CHMP v presojo predložila rezultate druge študije, študije preprečevanja kariesa pri odraslih (Prevention of Adult Caries Study, PACS), da bi potrdili do zdaj zbrane rezultate.
The significance of this preventive effect increases for high risk participants, for both all tooth surfaces and for coronal surfaces. 
Pomen tega preventivnega učinka se povečuje pri preiskovancih z velikim tveganjem, tako za vse zobne površine kot za površine krone.
It was concluded that the indication in patients at high-risk should be maintained and that the result seen with coronal surfaces should also be reflected. 
Zaključili so, da je treba indikacijo pri bolnikih z visokim tveganjem ohraniti in da je treba upoštevati rezultat za površine krone.
• and scientific discussion within the Committee the CHMP has recommended the granting of the marketing authorisation for which the summary of product characteristics and package leaflet are set out in Annex III for Prevora 
• in znanstvene razprave znotraj Odbora je CHMP priporočil odobritev dovoljenja za promet z zdravilom Prevora, katerega povzetek glavnih značilnosti zdravila in navodilo za uporabo sta navedena v Dodatku III.
However, when the result in high-risk patients is considered, a significant difference is seen between active and placebo. 
Če pa se upošteva rezultat pri bolnikih z visokim tveganjem, je vidna pomembna razlika med zdravilno učinkovino in placebom.
Therefore, Prevora appears to have a negative effect, resulting in more cavities in the at lowrisk population. 
Zato je videti, da ima zdravilo Prevora negativen učinek, kar povzroči več kavitet v populaciji z majhnim tveganjem.
The pivotal study included a total of 79 subjects on active. 
V ključno študijo je bilo vključenih skupno 79 preiskovancev.
In addition, the new trial also suggests a benefit for coronal surfaces, and no apparent differences between root and coronal surfaces. 
Poleg tega novo preskušanje nakazuje tudi koristi za površine krone ter nobene jasne razlike med površinami korenine in krone.
Dental caries is a bacterial based chronic disease. 
Zobna gniloba je kronična bolezen, ki jo povzročajo bakterije.
When risk (as measured by the number of cavities at screening) is added to the ANOVA model to account for the bimodal distribution of disease in this study population at both screening and during the study, an overall clinical effect of 36.8% at p = 0.04 is observed. 
Če se tveganje (izmerjeno s številom kavitet v fazi presejanja) doda v model ANOVA, da se upošteva bimodalna porazdelitev bolezni v populaciji te študije v fazi presejanja in med študijo, ugotovimo skupni klinični učinek 36,8 odstotka z vrednostjo p = 0,04.
Benefit-risk assessment 
Ocena koristi in tveganj
A 24.5% reduction for all tooth surfaces (root plus coronal surfaces) was seen with a p-value of 0.0322 [95% confidence interval (CI) of 0.62 - 0.98]. 
Ugotovili so 24,5-odstotno zmanjšanje na vseh zobnih površinah (površine korenine in krone) z vrednostjo p 0,0322 [95-odstotni interval zaupanja (IZ): 0,62-0,98].
There is no evidence of a difference in the point estimates for coronal and all surfaces which suggest that the results for root surfaces should be of a similar magnitude. 
Ni dokazov o razliki med točkovnimi ocenami za površine krone in vse površine, kar nakazuje, da bi morali biti rezultati za površine korenine enakega reda velikosti.
Clinical Study #002 (Dundee Adolescent Study) 
Klinična študija št. 2 (študija pri mladostnikih, Dundee)
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR POSITIVE OPINION AND AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EUROPEAN MEDICINES AGENCY 
PRILOGA II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA POZITIVNO MNENJE IN DOPOLNITEV POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
This is a Phase III, multi-centre, placebo-controlled, double-blinded, prospective study. 
Ta študija je multicentrična, s placebom nadzorovana, dvojno slepa, prospektivna študija III. faze.
The primary endpoint was the number of new cavities (coronal plus root surfaces) per participant, as measured at the end-of-study visit. 
Primarni cilj študije je bilo število novih kavitet (na površinah krone in korenine) na preiskovanca, izmerjeno ob zadnjem kontrolnem obisku v študiji.
A double-blind, randomised, multi-centred, controlled trial conducted in adults at risk of dental caries. 
Dvojno slepo, randomizirano, multicentrično, kontrolirano preskušanje pri odraslih s tveganjem zobne gnilobe.
The medicinal product, Prevora 100 mg/ml is a 10% w/v chlorhexidine dental solution indicated to reduce dental caries in permanent teeth of adolescents and adults. 
Zdravilo Prevora 100 mg/ml je 10-odstotna (w/v) dentalna raztopina klorheksidina, ki se uporablja za zmanjšanje zobne gnilobe na stalnih zobeh mladostnikov in odraslih.
These were patients between the ages of 11 and 13 years with evidence of past or current caries experience and elevated levels of salivary Streptococcus mutants. 
To so bili bolniki, stari od 11 do 13 let, z dokazano zobno gnilobo v preteklosti ali v času preskušanja ter zvišanimi ravnmi Streptococcus mutants v slini.
The CHMP assessing the apparent “reverse” treatment effect for at low-risk population explained this issue by the relative absence of high risk participants (those with 3+ cavities at screening) in the placebo groups where as the high-risk population (at risk population) had a higher baseline rate of cavities. 
CHMP je po vrednotenju navideznega „nasprotnega“ učinka zdravljenja v populaciji z majhnim tveganjem to vprašanje razložil z relativno odsotnostjo preiskovancev z visokim tveganjem (osebe s tremi kavitetami ali več v fazi presejanja) v skupini, ki je prejemala placebo, medtem ko je imela populacija z velikim tveganjem (populacija s tveganjem) višjo izhodiščno stopnjo kavitet.
‘Prevora 100mg/ml Dental Solution is an antiseptic solution which is applied topically to the dentition of patients for the prevention of coronal and root caries in adult patients at high-risk of dental caries (e.g. xerostomia sufferers or those with 3 or more caries at the start of the treatment plan). 
„Zdravilo Prevora 100 mg/ml dentalna raztopina je antiseptična raztopina, ki se nanese topično na zobovje bolnikov za preprečevanje zobne gnilobe na kroni in koreninah pri odraslih bolnikih z visokim tveganjem zobne gnilobe (npr. bolniki s kserostomijo ali 3 ali več karioznimi lezijami na začetku načrta zdravljenja).
It consists of a chlorhexidine coating solution (Stage 1) and an inert sealant coating (Stage 2) which is applied after the application of the chlorhexidine solution. 
Sestavlja ga raztopina klorheksidina za oblogo (1. stopnja) in inertna tesnilna obloga (2. stopnja), ki se nanese po nanosu raztopine klorheksidina.
A 3-year randomised double-blind trial in at-risk adolescent patients to evaluate the efficacy and safety of Prevora 100mg/ml Dental Solution in reducing caries increment. 
Triletno randomizirano, dvojno slepo preskušanje pri mladostnikih s tveganjem za razvoj bolezni, s katerim so ocenjevali učinkovitost in varnost zdravila Prevora 100 mg/ml dentalna raztopina pri zmanjševanju napredovanja zobne gnilobe.
The results were considered not compelling enough due to the unsupportive nature of the adolescent study (below). 
Rezultati se niso šteli za dovolj pomembne, ker študija na mladostnikih ne podpira zdravila (v nadaljevanju).
The study enrolled 983 at-risk adults and the study objectives were: determine the efficacy of Prevora in reducing cavities in at-risk adults, evaluate its safety, and evaluate the emergence if any, of chlorhexidineresistant Streptococcus mutans post treatment in study participants, and the emergence, if any, of opportunistic infections in the form of Candida albicans post treatment in study participants. 
V študijo so vključili 983 odraslih oseb s tveganjem za razvoj bolezni, cilji študije pa so bili: ugotoviti učinkovitost zdravila Prevora pri zmanjševanju kavitet pri odraslih osebah s tveganjem za razvoj bolezni, oceniti njegovo varnost ter oceniti morebiten pojav Streptococcus mutans, odpornega proti klorheksidinu, pri preiskovancih po zdravljenju in oportunističnih okužb s Candida albicans pri preiskovancih po zdravljenju.
The secondary endpoints were new coronal cavities and root cavities per participant. 
Sekundarna cilja študije sta bila nove kavitete na kroni in korenini na preiskovanca.
Clinical Study #001 (Adult Xerostomia Study) 
Klinična študija št. 1 (študija kserostomije pri odraslih)
This study was submitted as supportive data since it was a failed study, as no significant difference was found between placebo and Prevora as measured by the primary outcome variable. 
Ta študija je bila predložena kot podporni podatek, ker ni bila uspešna, saj z merjenjem s spremenljivko primarnega izida niso ugotovili pomembne razlike med placebom in zdravilom Prevora.
The PACS study failed on the primary endpoint as there was no difference between active and placebo in the number of caries per patient. 
Študija PACS je bila neuspešna glede primarnega cilja, saj ni bilo razlike med zdravilno učinkovino in placebom pri obsegu zobne gnilobe na bolnika.
The product is a topical two-stage chlorhexidine solution. 
Zdravilo je topična dvostopenjska raztopina klorheksidina.
For root surfaces, a 40.8% reduction with a p-value 0.0206 (95% CI of 0.23 - 0.78) and for coronal surfaces, no significant difference was seen between placebo and Prevora (p-value 
Na površinah korenine so ugotovili 40,8-odstotno zmanjšanje z vrednostjo p 0,0206 [95-odstotni interval zaupanja (IZ): 0,23-0,78], na površinah krone pa ni bilo pomembne razlike med placebom in zdravilom Prevora (vrednost p 0,0644).
Subsequent applications being based upon clinical judgment of caries risk by the dental professional. 
O nadaljnjih nanosih presodi zobozdravnik glede na klinični pregled tveganja zobne gnilobe.
Furthermore, it was agreed that the product information should also be amended to reflect that no significant resistance to Streptococcus mutans or opportunistic infections with Candida albicans were observed after treatment with Prevora over one year in adult patients. 
Poleg tega je bilo dogovorjeno, da se informacije o zdravilu spremenijo tako, da vsebujejo podatek, da v enem letu po zdravljenju z zdravilom Prevora pri odraslih bolnikih niso opazili pomembne odpornosti proti Streptococcus mutans ali oportunističnih okužb s Candida albicans.
Grounds for positive opinion and amendment of the summary of product characteristics and package leaflet 
Podlaga za pozitivno mnenje in dopolnilo povzetka glavnih značilnosti zdravila in navodila za uporabo
in high risk patients; 
zlasti rezultata študije PACS pri bolnikih z visokim tveganjem,
Prevora has been evaluated in two randomised, double-blinded, placebo-controlled clinical trials (RCTs) conducted according to GCP. 
Zdravilo Prevora so ocenili v dveh randomiziranih, dvojno slepih, s placebom nadzorovanih kliničnih preskušanjih, izvedenih skladno z dobro klinično prakso.
As defined by the primary endpoint, this study showed no significant difference between active and placebo. 
Glede na primarni cilj študija ni pokazala pomembne razlike med zdravilno učinkovino in placebom.
Considering the resistant and opportunistic infections, this study showed no significant resistance to Streptococcus mutans or opportunistic infections with Candida albicans after treatment with Prevora over one year in adult patients. 
V študiji so v zvezi z odpornimi in oportunističnimi okužbami dokazali, da v enem letu po zdravljenju z zdravilom Prevora pri odraslih bolnikih ni bilo pomembne odpornosti proti Streptococcus mutans ali oportunističnih okužb s Candida albicans.
• the assessment of all available data submitted by the MAH in particular the result from the PACS 
• vrednotenja razpoložljivih podatkov, ki jih je predložil imetnik dovoljenja za promet z zdravilom,
The comparison of caries increment was active versus placebo. 
Opravili so primerjavo napredovanja zobne gnilobe pri uporabnikih zdravilne učinkovine in uporabnikih placeba.
In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal was due to initial concerns expressed by the CAT that the data from the main study would not be sufficient to support the approval of the medicine. 
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da je umik posledica začetnih zadržkov, ki jih je izrazil odbor CAT, da podatki iz glavne študije ne bodo zadoščali za podporo odobritvi zdravila.
On 10 July 2018, FGK Representative Service GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Raligize, for the treatment of cancer of the cervix (the neck of the womb). 
Podjetje FGK Representative Service GmbH je 10. julija 2018 uradno obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Raligize, namenjenim zdravljenju raka cerviksa (materničnega vratu).
The company provided data from one main study involving 50 women with advanced cervical cancer, including cancer that had come back after other treatment or had spread elsewhere in the body. 
Družba je predložila podatke iz glavne študije, ki je vključevala 50 žensk z napredovalim rakom materničnega vratu, vključno z rakom, ki se je po zdravljenju z drugim zdravilom ponovil ali se je razširil drugam po telesu.
As the CAT was still evaluating the initial documentation provided by the company on behalf of the CHMP, it had not yet made any recommendations. 
Ker je odbor CAT v imenu odbora CHMP še vedno ocenjeval začetno dokumentacijo, ki jo je predložila družba, še ni podal nobenih priporočil.
The application was withdrawn while the CAT was still evaluating the initial documentation provided by the company. 
Vlogo so umaknili, ko je odbor CAT še vedno ocenjeval začetno dokumentacijo, ki jo je predložila družba.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Raligize. 
Družba je odbor CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Raligize.
Results of treatment with Raligize were compared with results previously seen in similar women given other treatments for cervical cancer. 
Rezultate zdravljenja z zdravilom Raligize so primerjali z rezultati, ki so jih predhodno opazili pri ženskah s podobnimi značilnostmi, ki so prejemale druga zdravila za zdravljenje raka materničnega vratu.
It was to be available as a concentrate for making up an infusion (drip) to be given into a vein. 
Na voljo naj bi bilo v obliki koncentrata za pripravo infuzije (kapalne infuzije) za dajanje v veno.
Because Raligize is an advanced therapy medicine, it was assessed on behalf of the CHMP by the Committee for Advanced Therapies (CAT). 
Zdravilo Raligize je zdravilo za napredno zdravljenje, zato ga je v imenu odbora CHMP ocenjeval Odbor za napredno zdravljenje (CAT).
Raligize was developed as a type of advanced therapy medicine called a ‘gene therapy product'. 
Zdravilo Raligize je bilo razvito kot vrsta zdravila za napredno zdravljenje, ki se imenuje „zdravilo za gensko zdravljenje“.
What is Raligize? 
Kaj je zdravilo Raligize?
Raligize is a cancer medicine containing the active substance axalimogene filolisbac. 
Raligize je zdravilo za zdravljenje raka, ki vsebuje učinkovino aksalimogen filolisbak.
Raligize was to be used to treat women with cervical cancer whose disease had not responded to, or had come back after, initial treatment. 
Zdravilo Raligize naj bi se uporabljalo za zdravljenje žensk z rakom materničnega vratu, pri katerih se bolezen ni odzvala na začetno zdravljenje ali se je ponovila.
What was Raligize expected to be used for? 
Za kaj naj bi se zdravilo Raligize uporabljalo?
The bacteria in Raligize have had a gene inserted in their DNA so they can produce a new substance containing one of the HPV proteins, E7, linked to part of another protein, listeriolysin O. The linked protein is able to stimulate the immune system against E7. 
Bakterijam v zdravilu Raligize so v njihovo DNK vstavili gen, tako da lahko proizvajajo novo snov, ki vsebuje eno od beljakovin virusa HPV, E7, povezano z delom druge beljakovine, listeriolizina O. Povezana beljakovina lahko spodbudi delovanje imunskega sistema proti E7.
How does Raligize work? 
Kako zdravilo Raligize deluje?
The active substance in Raligize, axalimogene filolisbac, consists of a bacterium, Listeria monocytogenes, that has been modified so it can produce a protein that stimulates the immune (defence) system to attack cancer cells. 
Učinkovina v zdravilu Raligize, aksalimogen filolisbak, vsebuje bakterijo Listeria monocytogenes, ki je bila spremenjena tako, da proizvaja beljakovino, ki imunski (obrambni) sistem spodbuja k napadu na rakave celice.
When Raligize is given to the patient, the bacteria are taken up by cells of the immune system where they stimulate it to recognize the E7 protein and attack and kill cancer cells that contain it. 
Ko bolnica prejme zdravilo Raligize, bakterije vstopijo v celice imunskega sistema in ga spodbudijo k prepoznavi beljakovine E7 ter k napadu in uničenju rakavih celic, ki vsebujejo to beljakovino.
Cervical cancer is mainly caused by long-lasting infection with certain strains of the human papillomavirus (HPV), which produce proteins in infected cells that stimulate them to grow and become cancerous. 
Rak materničnega vratu je večinoma posledica dolgotrajne okužbe z določenimi sevi humanega papilomavirusa (HPV).
* Tissue culture infectious dose 50% 
* 50% infektivnega odmerka za tkivno kulturo
--1 Lyophilisate (live attenuated) Canine distemper virus, strain Bio CDV 11/A 
--1 Liofilizat (živi atenuirani) Virus pasje kuge, sev CDV Bio 11/A
Canine parvovirus Type 2b, strain CPV-2b Bio 12/B 
Virus pasjega parvovirusa tipa 2b, sev CPV-2b Bio 12/B 104,3 -106,6 TCID50* Virus pasje parainfluence tipa 2, sev CPiV-2 Bio 15
The European Commission granted a marketing authorisation valid throughout the European Union for ReFacto AF on 13 April 1999. 
Evropska komisija je dovoljenje za promet z zdravilom ReFacto AF, veljavno po vsej Evropski uniji, izdala 13. aprila 1999.
The full EPAR for ReFacto AF 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 ReFacto AF je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
What measures are being taken to ensure the safe and effective use of ReFacto AF? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila ReFacto AF?
Therefore, the Committee decided that the benefits of ReFacto AF are greater than its risks and recommended that it be given marketing authorisation. 
Odbor je zato zaključil, da so koristi zdravila ReFacto AF večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Following these changes, the company carried out a study to show that ReFacto and ReFacto AF were treated by the body in the same way. 
Po teh spremembah je družba izvedla študijo, da bi dokazala, da se telo na zdravili ReFacto in ReFacto AF odziva enako.
These are known as inhibitors as they can prevent the medicine from working effectively, which may result in a loss of bleeding control. 
Ta so znana kot zaviralci, saj lahko preprečijo učinkovito delovanje zdravila, kar ima lahko za posledico izgubo nadzora nad krvavitvijo.
What benefit has ReFacto AF shown during the studies? 
Kakšne koristi je zdravilo ReFacto AF izkazalo med študijami?
It also carried out two main studies looking at the effectiveness of ReFacto AF: the first looked at the prevention and treatment of bleeding episodes in 94 previously treated patients and the second looked at the prevention of bleeding in 22 patients having surgery. 
Izvedla je tudi dve glavni študiji, v katerih je proučila učinkovitost zdravila ReFacto AF: v prvi študiji so raziskovali preprečevanje in zdravljenje epizod krvavenja pri 94 predhodno zdravljenih bolnikih, v drugi pa preprečevanje krvavenja pri 22 bolnikih po operativnem posegu.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Refacto AF have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila ReFacto AF, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Patients or their carers can give injections of ReFacto AF, provided that they have been trained appropriately. 
Bolniki ali njihovi negovalci lahko zdravilo ReFacto AF injicirajo sami, če so bili za to ustrezno usposobljeni.
The human coagulation factor VIII in ReFacto AF is not extracted from human blood but is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce human coagulation factor VIII. 
Humani koagulacijski faktor VIII v zdravilu ReFacto AF se ne pridobiva iz človeške krvi, temveč se proizvaja z metodo, znano kot “tehnologija rekombinantne DNK”, pri kateri celica prejme gen (DNK), s katerim lahko tvori humani koagulacijski faktor VIII.
For more information about treatment with ReFacto AF, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom ReFacto AF preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The dose and the frequency of treatment depend on whether ReFacto AF is used to treat or prevent bleeding, the seriousness of the condition, the extent and location of the bleeding or the type of surgery, and the patient's bodyweight. 
Odmerek in pogostnost odmerjanja sta odvisna od tega, ali se zdravilo ReFacto AF uporablja za zdravljenje ali preprečevanje krvavitve, od resnosti stanja, mesta in obsežnosti krvavitve ali vrste operativnega posega ter bolnikove telesne mase.
Other information about ReFacto AF 
Druge informacije o zdravilu ReFacto AF
The CHMP noted that ReFacto AF was comparable to ReFacto, the original form of the medicine. 
CHMP je ugotovil, da je zdravilo ReFacto AF primerljivo z prvotno obliko zdravila, tj. zdravilom ReFacto.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for ReFacto AF. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo ReFacto AF, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.