natgillin/translations-raw huggingface dataset:
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.
The active substance in ReFacto AF, moroctocog alfa, works in the body in the same way as human factor VIII.
Zdravilna učinkovina v zdravilu ReFacto AF, moroktokog alfa, deluje v telesu enako kot humani faktor VIII.
In February 2009, a number of changes to the way ReFacto is made were introduced.
Februarja 2009 se je način izdelave zdravila ReFacto bistveno spremenil.
This is a summary of the European public assessment report (EPAR) for ReFacto AF.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo ReFacto AF.
ReFacto AF was first authorised as ReFacto in April 1999, for use in previously treated and untreated patients with haemophilia A, based on the results of three main studies.
Zdravilo ReFacto AF je bilo najprej odobreno aprila 1999 kot zdravilo ReFacto za uporabo pri bolnikih s predhodno zdravljeno ali nezdravljeno hemofilijo A na podlagi rezultatov treh glavnih študij.
Full details on how to calculate the dose are included in the summary of product characteristics (also part of the EPAR).
Podrobnejši podatki o izračunavanju ustreznega odmerka so na voljo v povzetku glavnih značilnosti zdravila (ki je prav tako del EPAR).
Uncommonly, patients may also develop allergic reactions.
Redko so lahko pri bolnikih izzvane alergijske reakcije.
The most common side effects with ReFacto AF (seen in more than 1 patient in 10) are headache, cough, pain in the joints and fever.
Najpogostejši neželeni učinki zdravila ReFacto AF (opaženi pri več kot 1 bolniku od 10) so glavobol, kašelj, bolečine v sklepih in povišana telesna temperature.
ReFacto AF can be used in patients of all ages, including newborns.
Zdravilo ReFacto AF je primerno za uporabo pri bolnikih vseh starosti, vključno z novorojenčki.
Patients may also develop antibodies against factor VIII medicines such as Refacto AF.
Bolniki lahko pri zdravilih, kot je ReFacto AF razvijejo protitelesa faktorja VIII.
Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily and may have problems, such as bleeding in the joints, muscles and internal organs.
Bolnikom s hemofilijo A primanjkuje faktorja VIII, tj. beljakovine, ki je potrebna za normalno strjevanje krvi, zato hitreje zakrvavijo in imajo lahko težave, kot so krvavitve v sklepih, mišicah in notranjih organih.
These included removal of the use of a protein called albumin, which is produced from human blood, from the manufacturing process.
Med drugim se je v proizvodnem procesu prenehala uporabljati beljakovina, imenovana albumin, ki se pridobiva iz človeške krvi.
ReFacto AF is given by injection into a vein over several minutes.
Zdravilo ReFacto AF se z injekcijo dovaja v veno več minut.
ReFacto AF must not be used in people who are hypersensitive (allergic) to human coagulation factor VIII, to any of the other ingredients or to hamster proteins.
Zdravila ReFacto AF ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) humani koagulacijski faktor VIII, za katero koli drugo sestavino zdravila ali za beljakovine hrčka.
The name of the medicine was also changed from ReFacto to ReFacto AF.
Spremenjeno je bilo tudi ime zdravila, iz ReFacto v ReFacto AF.
ReFacto AF should be started under the supervision of a doctor who has experience in the treatment of haemophilia A.
Zdravljenje z zdravilom ReFacto AF mora uvesti zdravnik, ki ima izkušnje z zdravljenjem hemofilije A.
It is available as vials or pre-filled syringes.
Na voljo je v vialah ali predhodno napolnjenih injekcijskih brizgah.
ReFacto AF is used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder).
Zdravilo ReFacto AF se uporablja za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo A (prirojeno motnjo strjevanja krvi).
For the full list of all side effects reported with ReFacto AF, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila ReFacto AF, glejte navodilo za uporabo.
Why has ReFacto AF been approved?
Zakaj je bilo zdravilo ReFacto AF odobreno?
ReFacto AF contains the active substance moroctocog alfa.
Zdravilo ReFacto AF vsebuje zdravilno učinkovino moroktokog alfa.
What is the risk associated with ReFacto AF?
Kakšna tveganja so povezana z zdravilom ReFacto AF?
How has ReFacto AF been studied?
Kako je bilo zdravilo ReFacto AF raziskano?
The studies showed that ReFacto AF was as safe and effective as ReFacto in preventing and treating bleeding episodes in patients with haemophilia A.
Študije so pokazale, da je zdravilo ReFacto AF pri preprečevanju in zdravljenju epizod krvavitev pri bolnikih s hemofilijo A enako varno in učinkovito kot zdravilo ReFacto.
ReFacto AF is a powder and solvent used to make up a solution for injection.
Zdravilo ReFacto AF sestavljata prašek in vehikel, ki se zmešata v raztopino za injiciranje.
What is ReFacto AF used for?
Za kaj se zdravilo ReFacto AF uporablja?
How is ReFacto AF used?
Kako se zdravilo ReFacto AF uporablja?
What is ReFacto AF?
Kaj je zdravilo ReFacto AF?
MA (EU) Number
Št. dovoljenja za promet (EU)
(Invented) name Strength Pharmaceutical Form
(Lastniško) ime Jakost
However it should be noted that patients in this study were given doses higher than the recommended dose (up to 10 mg twice a day).
Vendar je treba omeniti, da so bolniki v tej študiji prejemali večje odmerke od priporočenega odmerka (do 10 mg dvakrat na dan).
Side effects reported with this medicine are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri tem zdravilu, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
It must not be used in women who are pregnant, breastfeeding or by women who could become pregnant and who are not using appropriate contraceptives.
Ne smejo ga uporabljati nosečnice, doječe matere ali ženske, ki bi lahko zanosile in ki ne uporabljajo ustreznih kontracepcijskih sredstev.
This authorisation was based on the authorisation granted to Procoralan in 2005 (‘informed consent').
Izdaja tega dovoljenja je temeljila na dovoljenju za promet z zdravilom Procoralan, ki je bilo izdano leta 2005 (uporaba dokumentacije s soglasjem).
Further information on Ivabradine Anpharm can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Ivabradine-Anpharm.
Več informacij o zdravilu Ivabradine Anpharm je na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Ivabradine-Anpharm.
When used for angina, treatment should be stopped if symptoms do not improve after 3 months.
Kadar se uporablja za zdravljenje angine pektoris, je treba zdravljenje prekiniti, če se simptomi po treh mesecih ne izboljšajo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ivabradine Anpharm have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ivabradine Anpharm upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Ivabradine Anpharm is available as tablets (5 and 7.5 mg) and can only be obtained with a prescription.
Zdravilo Ivabradine Anpharm je na voljo v obliki tablet (5 in 7,5 mg), predpisovanje in izdaja pa je le na recept.
Ivabradine Anpharm must not be taken with a number of other medicines.
Zdravilo Ivabradine Anpharm se ne sme jemati skupaj s številnimi drugimi zdravili.
However, a fifth study in 728 patients showed that adding Ivabradine Anpharm to amlodipine did not provide an additional benefit.
V peti študiji s 728 bolniki pa so dokazali, da dodajanje zdravila Ivabradine Anpharm amlodipinu ne prinaša dodatnih koristi.
Ivabradine Anpharm received a marketing authorisation valid throughout the EU on 8 September 2015.
Za zdravilo Ivabradine Anpharm je bilo 8. septembra 2015 izdano dovoljenje za promet, veljavno po vsej EU.