FrancophonIA/ELRC3.0 huggingface dataset:
English: Plastic box containing 3 vials of 1 dose of lyophilisate and 3 vials of 1 ml of solvent.
Slovenian: Plastična škatla s 3 vialami z 1 dozo liofilizata in 3 vialami z 1 ml topila.
English: Plastic box containing 30 vials of 1 dose of lyophilisate and 30 vials of 1 ml of solvent.
Slovenian: Plastična škatla s 30 vialami z 1 dozo liofilizata in 30 vialami z 1 ml topila.
English: Plastic box containing 1 vial of 1 dose of lyophilisate and 1 vial of 1 ml of solvent.
Slovenian: Plastična škatla z 1 vialo z 1 odmerkom liofilizata in 1 vialo z 1 ml vehikla.
English: Plastic box containing 25 vials of 1 dose of lyophilisate and 25 vials of 1 ml of solvent.
Slovenian: Plastična škatla s 25 vialami z 1 dozo liofilizata in 25 vialami z 1 ml topila.
English: Sucrose
Slovenian: KARENCA
English: Plastic box containing 10 vials of 1 dose of lyophilisate and 10 vials of 1 ml of solvent.
Slovenian: Plastična škatla z 10 vialami z 1 odmerkom liofilizata in 10 vialami z 1 ml vehikla.
English: Fax.
Slovenian: Subkutana .
English: Plastic box containing 15 vials of 1 dose of lyophilisate and 15 vials of 1 ml of solvent.
Slovenian: Plastična škatla s 15 vialami z 1 dozo liofilizata in 15 vialami z 1 ml topila.
English: Plastic box containing 5 vials of 1 dose of lyophilisate and 5 vials of 1 ml of solvent.
Slovenian: Plastična škatla s 5 vialami z 1 dozo liofilizata in 5 vialami z 1 ml topila.
English: Plastic box containing 50 vials of 1 dose of lyophilisate and 50 vials of 1 ml of solvent.
Slovenian: Plastična škatla s 50 vialami z 1 odmerkom liofilizata in 50 vialami z 1 ml vehikla.
English: No adverse reactions other than those mentioned in section 6 were observed after the administration of a double-dose of the vaccine.
Slovenian: Po dajanju dvojnega odmerka cepiva niso opazili neželenih učinkov, razen tistih, navedenih v poglavju
English: Interactions with other medicinal products
Slovenian: POT(I) UPORABE ZDRAVILA
English: London, 20 November 2008 Doc.
Slovenian: London, 20. november 2008 Sklic dok.
English: Ref. EMEA/586612/2008
Slovenian: EMEA/650811/2008
English: The antibiotics were given for up to 14 days.
Slovenian: Bolniki so antibiotike prejemali do 14 dni.
English: International non-proprietary name (INN): telavancin
Slovenian: Mednarodno nelastniško ime (INN): telavancin
English: The main measure of effectiveness was the number of patients whose infection had been cured after the end of treatment.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih je bila okužba po koncu zdravljenja ozdravljena.
English: The studies were carried out at sites where infection with MRSA is common.
Slovenian: Študiji sta bili izvedeni na lokacijah, kjer je okužba z MRSA pogosta.
English: The effects of Vibativ were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Vibativ so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: The Committee was also concerned that Vibativ may cause ‘QTc prolongation' (an alteration of the electrical activity of the heart).
Slovenian: Odbor je bil zaskrbljen tudi glede tega, da bi lahko Vibativ povzročil „podaljšanje intervala QTc“ (spremembo električne aktivnosti srca).
English: Together, the cell wall and membrane form a barrier between the bacterial cell contents and the external environment.
Slovenian: Celična stena in membrana skupaj tvorita pregrado med vsebino bakterijske celice in zunanjim okoljem.
English: The CHMP also had concerns regarding the production of the medicine, its stability and the possible presence of impurities.
Slovenian: CHMP je imel zadržke tudi glede proizvodnje zdravila, njegove stabilnosti in možne prisotnosti nečistoč.
English: These include Staphylococcus aureus (including ‘methicillin-resistant' forms known as ‘MRSA') and Streptococcus pyogenes.
Slovenian: Te vključujejo Staphylococcus aureus (vključno s tistimi oblikami, ki so odporne na meticilin, poznane kot „MRSA“) in Streptococcus pyogenes.
English: Questions and answers on the withdrawal of the marketing application for Vibativ
Slovenian: Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Vibativ
English: ‘Complicated' means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment.
Slovenian: „Zapletena“ pomeni, da je okužbo težko zdraviti, ker se je razširila globoko v podkožno tkivo, ali da je morda potrebno zdravljenje s kirurškim posegom ali pa ima bolnik še druge zdravstvene težave, ki lahko vplivajo na odziv na zdravljenje.
English: What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Vibativ?
Slovenian: Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Vibativ?
English: By disrupting this barrier, telavancin is expected to kill the bacteria that are causing the infection.
Slovenian: Z oviranjem delovanja te pregrade naj bi telavancin uničil bakterije, ki povzročajo okužbo.
English: Vibativ was compared with vancomycin (another antibiotic) in two main studies involving a total of 2,079 adults with complicated skin and soft tissue infections due to Gram-positive bacteria.
Slovenian: Zdravilo Vibativ so primerjali z vankomicinom (drugim antibiotikom) v dveh glavnih študijah, ki sta vključevali skupno 2 079 odraslih z zapletenimi okužbami kože in mehkega tkiva zaradi grampozitivnih bakterij.
English: On 20 October 2008, Astellas Pharma Europe B. V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Vibativ, for the treatment of complicated skin and soft tissue infections in adults.
Slovenian: Družba Astellas Pharma Europe B. V. je dne 20. oktobra 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Vibativ, namenjenim zdravljenju zapletenih okužb kože in mehkega tkiva pri odraslih.
English: The active substance in Vibativ, telavancin, is an antibiotic that belongs to the group ‘glycopeptides'.
Slovenian: Zdravilna učinkovina v zdravilu Vibativ, telavancin, je antibiotik, ki spada v skupino „glikopeptidov“.
English: The company informed the CHMP that there are currently no clinical trials or compassionate use programmes ongoing with Vibativ.
Slovenian: Družba je obvestila CHMP, da trenutno ne potekajo nobena klinična preskušanja ali programi sočutne uporabe zdravila Vibativ.
English: Hence, the CHMP recommended that Vibativ be refused marketing authorisation.
Slovenian: CHMP je zato priporočil zavrnitev dovoljenja za promet z zdravilom Vibativ.
English: It is expected to work in two ways, both by stopping the bacteria making their cell walls and by disrupting their cell membranes.
Slovenian: Deloval naj bi na dva načina, in sicer s preprečevanjem izgradnje celične stene bakterije in z oviranjem delovanja njihove celične membrane.
English: The CHMP was concerned that there was no additional benefit of Vibativ over vancomycin, and could cause more kidney damage than vancomycin.
Slovenian: CHMP je bil zaskrbljen, ker zdravilo Vibativ nima dodatnih koristi v primerjavi z vankomicinom in lahko povzroči večjo poškodbo ledvic kot vankomicin.
English: Vibativ was to be used only when the infection was known or thought to be caused by types of bacteria that are classified as ‘Gram-positive'.
Slovenian: Zdravilo Vibativ bi se naj uporabljalo samo v primeru, ko vemo ali menimo, da okužbo povzročajo vrste bakterij, ki spadajo med „grampozitivne“ bakterije.
English: Based on the review of the data and the company's responses to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Vibativ could not have been approved for the treatment of complicated skin and soft tissue infections in adults.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da se zdravila Vibativ ne more odobriti za zdravljenje zapletenih okužb kože in mehkega tkiva pri odraslih.
English: What is Vibativ?
Slovenian: Kaj je zdravilo Vibativ?
English: What was Vibativ expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Vibativ uporabljalo?
English: The application was at day 201 when the company withdrew.
Slovenian: Družba je vlogo umaknila na 201. dan postopka.
English: Vibativ was expected to be used to treat adults with complicated infections of the skin and the ‘soft tissues' below the skin.
Slovenian: Zdravilo Vibativ naj bi se uporabljalo za zdravljenje odraslih z zapletenimi okužbami kože in „mehkega tkiva“, ki se nahaja pod kožo.
English: How is Vibativ expected to work?
Slovenian: Kako naj bi zdravilo Vibativ delovalo?
English: Vibativ is a powder to be made up into a solution for infusion (drip into a vein).
Slovenian: Zdravilo Vibativ je prašek za pripravo raztopine za infundiranje (kapalne infuzije v veno).
English: It contains the active substance telavancin.
Slovenian: Vsebuje zdravilno učinkovino telavancin.
English: At that point in time, the CHMP was of the opinion that the benefits of Vibativ in the treatment of complicated skin and soft tissue infections in adults did not outweigh its risks.
Slovenian: CHMP je bil mnenja, da koristi zdravila Vibativ pri zdravljenju zapletenih okužb kože in mehkega tkiva pri odraslih ne odtehtajo z njim povezanih tveganj.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before
Slovenian: Ko družba predloži odgovore na vprašanja, jih CHMP pregleda in lahko pred izdajo svojega mnenja na 180. dan postopka zastavi morebitna druga vprašanja.
English: • The Committee considered (Co-)Rapporteur's assessment report;
Slovenian: • odbor je upošteval poročilo o oceni (so-)poročevalca;
English: Annex II Scientific conclusions
Slovenian: Priloga II Znanstveni zaključki
English: This minor difference in concentration (5.93%) is expected to be reduced even more by the available saliva in the mouth.
Slovenian: Ta manjša razlika v koncentraciji (5,93 %) naj bi se zaradi razpoložljive sline v ustih še zmanjšala.
English: This justification was accepted by the CHMP.
Slovenian: Odbor CHMP je to obrazložitev sprejel.
English: Grounds for the CHMP opinion
Slovenian: Podlaga za mnenje odbora CHMP
English: The benefit-risk balance of the applied medicinal product is considered positive.
Slovenian: Razmerje med tveganji in koristmi predlaganega zdravila velja za pozitivno.
English: • The Committee considered the totality of the data submitted by the applicant in relation to the objections raised as potential serious risk to public health and the questions asked by the CHMP;
Slovenian: • odbor je proučil vse podatke, ki jih je predložil predlagatelj v odziv na zadržke glede morebitnih resnih tveganj za javno zdravje in vprašanja, ki mu jih je odbor zastavil;
English: First, the lower amount of cyclodextrins is preferable from a safety point of view.
Slovenian: Prvič, manjša količina ciklodekstrinov je s stališča varnosti boljša.
English: The product information remains as per the final version achieved during the Coordination group procedure as mentioned in Annex III of the CHMP opinion.
Slovenian: Informacije o zdravilu ostajajo take, kot so v končni različici, pripravljeni v postopku skupine za usklajevanje, kakor je navedeno v Prilogi III k mnenju odbora CHMP.
English: • The Committee was of the view that the submitted in-vitro studies and bibliographical data demonstrate sufficiently the safety and efficacy of the medicinal product.
Slovenian: • odbor je menil, da predložene študije in vitro in bibliografski podatki zadovoljivo dokazujejo varnost in učinkovitost zdravila,
English: The CHMP also considered that the different amount of cyclodextrins is not of concern.
Slovenian: Odbor CHMP je menil tudi, da razlika v količini ciklodekstrinov ni zaskrbljujoča.
English: However, there are some quantitative and qualitative differences among the products which concern:
Slovenian: Kljub temu je med zdraviloma nekaj količinskih in kakovostnih razlik, ki se nanašajo na:
English: The applicant has requested a waiver of the need to conduct clinical studies.
Slovenian: Predlagatelj je zaprosil za izvzetje iz obveznosti izvedbe kliničnih študij.
English: The drug inhibits the synthesis of prostaglandins by mixed inhibition of the enzymes COX-1/COX-2 with some selectivity towards COX-1.
Slovenian: Zdravilo zavira sintezo prostaglandinov z mešanim zaviranjem encimov COX-1/COX-2, z določeno selektivnostjo do COX-1.
English: Therefore, this difference in concentration is considered insignificant and clinically irrelevant, taking into consideration that eventually the same dose is administered locally.
Slovenian: Zato ta razlika v koncentraciji velja za nepomembno in klinično brezpredmetno, ob upoštevanju, da je lokalno uporabljen praktično enak odmerek.
English: The removal of one of the flavours from the formulation had been discussed as a factor that could potentially affect the saliva secretion resulting in an unequal contribution to the local action.
Slovenian: O odstranitvi ene od arom iz formulacije so razpravljali kot o dejavniku, ki bi lahko vplival na izločanje sline, to pa bi privedlo do neenakomernega prispevka k lokalnemu delovanju.
English: So in the hypothetical scenario of a difference in the amount of produced saliva this would not impact on the absorbed amount of the active substance.
Slovenian: V hipotetičnem scenariju različnih količin nastale sline to ne bi vplivalo na absorbirano količino učinkovine.
English: On the top of that, flurbiprofen is a highly permeable and passively absorbed drug of which the permeability is not altered by a difference in concentration.
Slovenian: Poleg tega je flurbiprofen močno permeabilno in pasivno absorbirano zdravilo, katerega permeabilnost se zaradi razlike v koncentraciji ne spremeni.
English: The therapeutic equivalence has been claimed to be demonstrated based on in-vitro data only.
Slovenian: Terapevtska enakovrednost naj bi bila dokazana samo na podlagi podatkov in vitro.
English: The proposed indication is ‘pain relief of mild to moderate symptoms of acute sore throat'.
Slovenian: Predlagana indikacija je „lajšanje bolečin pri blagih do zmernih simptomih akutnega vnetja žrela“.
English: The proposed indication is short-term symptomatic relief of sore throat.
Slovenian: Predlagana indikacija je kratkotrajno lajšanje simptomov vnetega žrela.
English: Literature data (Radkova et al., 2017, Imai et al., 1988) demonstrate that different formulations of flurbiprofen (spray and lozenges) displayed comparable efficacy and safety profiles, despite the lack of cycloextrins from lozenges, and were also taken into consideration.
Slovenian: Podatki iz literature (Radkova idr., 2017, Imai idr., 1988) dokazujejo, da različne formulacije flurbiprofena (pršilo in pastile) kažejo primerljiva profila učinkovitosti in varnosti, kljub odsotnosti ciklodekstrinov v pastilah, kar je bilo tudi upoštevano.
English: The CHMP considered that the removal of the mint flavour is considered clinically irrelevant in this specific case.
Slovenian: Odbor CHMP je menil, da je odstranitev arome mete v tem primeru klinično nepomembna.
English: • The Committee considered the referral under Article 29(4) of Directive 2001/83/EC;
Slovenian: • odbor je obravnaval napotitev v skladu s členom 29(4) Direktive 2001/83/ES;
English: ii) the amount of cyclodextrins: the amount of cyclodextrins is lower in the test product compared to this of the reference medicinal product;
Slovenian: (ii) količino ciklodekstrinov: količina ciklodekstrinov v testnem zdravilu je manjša od njihove količine v referenčnem zdravilu;
English: The CHMP considered that the noted differences between the reference and test product are minor and the applicant has sufficiently demonstrated why these differences do not affect the local efficacy, safety or the systemic absorption of the product.
Slovenian: Odbor CHMP je ocenil, da so opažene razlike med referenčnim in testnim zdravilom zanemarljive in da je predlagatelj zadovoljivo dokazal, zakaj te razlike ne vplivajo na lokalno učinkovitost, varnost ali sistemsko absorpcijo zdravila.
English: If bioequivalence has been established among such different formulations, the minor differences in the present case will not affect the pharmacokinetic and clinical profile of the test product.
Slovenian: Če je bila bioekvivalenca dokazana med temi različnimi formulacijami, manjše razlike v tem primeru ne bodo vplivale na farmakokinetični in klinični profil testnega zdravila.
English: Moreover, it was emphasised that the originator has demonstrated bioequivalence between the oromucosal spray (Strefen Direct 8,75 mg Oromucosal spray) and lozenges (Strepflam 8,75 mg Lozenges), for which more significant formulation differences exist.
Slovenian: Poudarili so tudi, da je originator dokazal bioekvivalenco oralnega pršila (Strefen Direct 8,75 mg oralno pršilo) in pastil (Strepflam 8,75 mg pastile), med katerima obstajajo pomembnejše razlike v formulaciji.
English: During the decentralised procedure (DCP) and the CMDh procedure, the RMS (ES) considered that the above mentioned differences were minor and without a clinical impact on the efficacy and safety of the test product.
Slovenian: Med decentraliziranim postopkom in postopkom skupine CMDh je referenčna država članica (ES) menila, da so zgoraj navedene razlike manjše ter nimajo kliničnega vpliva na učinkovitost in varnost testnega zdravila.
English: The originator product is Strepflam 8.75 Lozenges by Crookes Healthcare/Reckitt Benckiser Healthcare, which has been registered since June 2001.
Slovenian: Originatorsko zdravilo je zdravilo Strepflam 8,75 mg pastile podjetja Crookes Healthcare/Reckitt Benckiser Healthcare, ki je registrirano od junija 2001.
English: No clinical studies have been contacted and instead the applicant requested a biowaiver.
Slovenian: Klinične študije niso bile opravljene; namesto tega je predlagatelj zaprosil za izvzetje iz obveznosti izvedbe študij biološke enakovrednosti.
English: The Committee, as a consequence, considers that the benefit-risk balance of Flurbiprofen Geiser 8,75 mg oromucosal spray, solution and associated names is favourable and therefore recommends the granting of the marketing authorisation(s) for the medicinal products referred to in Annex I of the CHMP opinion.
Slovenian: odbor zato ocenjuje, da je razmerje med tveganji in koristmi zdravila Flurbiprofen Geiser 8,75 mg oralno pršilo, raztopina, in povezanih imen pozitivno, zato priporoča izdajo dovoljenja (dovoljenj) za promet z zdravili, navedenimi v Prilogi I k mnenju odbora CHMP.
English: The test product has some quantitative and qualitative differences with the reference product, namely;
Slovenian: Testno zdravilo ima nekaj kvantitativnih in kvalitativnih razlik v primerjavi z referenčnim zdravilom, in sicer:
English: The reference medicinal product was Strefen Direct 8,75 mg Oromucosal spray (UK/H/5072/001).
Slovenian: Referenčno zdravilo je bilo zdravilo Strefen Direct 8,75 mg oralno pršilo (UK/H/5072/001).
English: Flurbiprofen belongs to the non-steroidal anti-inflammatory class of medicines (NSAID) which have analgesic, antipyretic, and anti-inflammatory properties.
Slovenian: Flurbiprofen spada v razred nesteroidnih protivnetnih zdravil (NSAID), ki imajo analgetične, antipiretične in protivnetne lastnosti.
English: The application for Strefen Direct 8,75 mg Oromucosal spray was made under Article 8(3) of Directive 2001/83/EC.
Slovenian: Vloga za zdravilo Strefen Direct 8,75 mg oralno pršilo je bila predložena v skladu s členom 8(3) Direktive 2001/83/ES.
English: Second, flurbiprofen is moderately bound to the cyclodextrins and the release of the active substance is immediate when it comes in contact with the buccal membrane.
Slovenian: Drugič, flurbiprofen se zmerno veže na ciklodekstrin in učinkovina se sprosti takoj, ko pride v stik z ustno sluznico.
English: The assessment was performed having in mind that this was this is a hybrid application under Article 10(3) of Directive 2001/83/EC.
Slovenian: Pri oceni se je upoštevalo, da je šlo za hibridno vlogo v skladu s členom 10(3) Direktive 2001/83/ES.
English: Based on the in-vitro tests, equivalence has been shown between the reference and the test products with respect to the following quality attributes: amount of active substance in each dose, the particle size, the plume geometry and the spray pattern.
Slovenian: Na podlagi preskusov in vitro je bila dokazana enakovrednost referenčnega in testnega zdravila, kar zadeva naslednje kakovostne lastnosti: količina učinkovine v posameznem odmerku, velikost delcev, geometrija izpusta in vzorec pršenja.
English: Overall summary of the scientific evaluation by the CHMP Flurbiprofen Geiser 8,75 mg oromucosal spray, is a non-steroidal anti-inflammatory (NSAID) with analgesic, antipyretic, and anti-inflammatory properties.
Slovenian: Splošni povzetek znanstvenega vrednotenja odbora CHMP Zdravilo Flurbiprofen Geiser 8,75 mg oralno pršilo je nesteroidno protivnetno zdravilo (NSAID) z analgetičnimi, antipiretičnimi in protivnetnimi lastnostmi.
English: i) the concentration: 17.16 mg/ml in the test medicinal product versus 16.20 mg/ml in the reference product;
Slovenian: (i) koncentracijo: 17,16 mg/ml v testnem zdravilu v primerjavi s 16,20 mg/ml v referenčnem zdravilu;
English: The application was submitted under Article 10(3) of Directive 2001/83/EC.
Slovenian: Vloga je bila predložena v skladu s členom 10(3) Direktive 2001/83/ES.
English: The saliva secretion does not play a relevant contribution in the in-vivo performance of the buccal spray since most of the content of the spray is swallowed as a consequence of gag the reflex caused by the impact of the spray in the throat, without any time to be affected by the secretion of saliva.
Slovenian: Izločanje sline ne prispeva pomembno k delovanju ustnega pršila in vivo, saj večino vsebine pršila pogoltnemo, in sicer zaradi refleksa bruhanja, ki ga povzroči pršilo v grlu, pri tem pa ni časa, da bi pršilo vplivalo na izločanje sline.
English: Results from the in-vitro tests performed by the applicant have shown equivalence in the critical quality attributes that were tested (single actuation content, droplet size distribution, drug small particles, spray pattern, plum geometry and priming), suggesting that the quantitative and qualitative differences between the reference and the test medicinal products do not affect the deposition of the spray in the site of action (the buccal cavity).
Slovenian: Rezultati preskusov in vitro, ki jih je opravil predlagatelj, so pokazali enakovrednost preskušanih ključnih kakovostnih lastnosti (vsebnost ob enkratni sprožitvi, porazdelitev velikosti kapljic, majhni delci zdravila, vzorec razpršitve, geometrija izpusta in aktivacija), kar kaže, da kvantitativne in kvalitativne razlike med referenčnim in testnim zdravilom ne vplivajo na odlaganje pršila na mesto delovanja (ustna votlina).
English: With regards to the different concentration (17.16 mg/ml vs. 16.20 mg/ml), it was noted that that due to the different sprayed volumes (0.17 mL vs. 0.18 mL), the delivered dose is eventually the same.
Slovenian: Kar zadeva različno koncentracijo (17,16 mg/ml v primerjavi s 16,20 mg/ml), je bilo ugotovljeno, da je zaradi različnih volumnov pršenja (0,17 ml v primerjavi z 0,18 ml) dani odmerek praktično enak.