natgillin/translations-raw huggingface dataset:
Following a request from the applicant at the time of the re-examination, the CHMP convened a Scientific Advisory Group (SAG) Diabetes Endocrinology with additional experts, inviting the experts to provide their views on the CHMP grounds for refusal, taking into account the applicant's response. 
Ob ponovnem pregledu je odbor CHMP na predlagateljevo zahtevo sklical znanstveno svetovalno skupino za endokrinologijo sladkorne bolezni z dodatnimi strokovnjaki in pozval strokovnjake, naj ob upoštevanju predlagateljevega odgovora predložijo svoje mnenje o razlogih odbora CHMP za zavrnitev.
Psychiatric safety -Depression, anxiety and cognitive impairment were more commonly reported in patients treated with Qsiva than placebo. 
Psihiatrična varnost - o depresiji, anksioznosti in poslabšanih kognitivnih funkcijah so pogosteje poročali pri bolnikih, ki so bili zdravljeni z zdravilom Qsiva, kot pri bolnikih, zdravljenih s placebom.
Known adverse events with the use of phentermine are palpitations, tachycardia, elevation of blood pressure, psychosis, CNS and gastrointestinal effects and with the use of topiramate paraesthesia, changes in taste, ocular disorders, psychiatric and cognitive disorders. 
Znani neželeni dogodki ob uporabi fentermina so palpitacije, tahikardija, dvig krvnega tlaka, psihoza, učinki na osrednje živčevje in prebavila, ob uporabi topiramata pa parestezija, spremembe okušanja, očesna obolenja, psihiatrične in kognitivne motnje.
However, it was recognised that effectiveness of the PPP in clinical practice will be difficult to maintain in the long term use. 
Odbor je izpostavil, da bo učinkovitost načrta za preprečevanje nosečnosti pri dolgotrajni uporabi v klinični praksi težko ohranjati.
The currently available cardiovascular outcome data for Qsiva remains inconclusive; 
Trenutno razpoložljivi podatki o kardiovaskularnem izidu za zdravilo Qsiva ostajajo nedoločni;
In the view of the CHMP, any increase in heart rate can remain a concern with regard to CV risk. 
Po mnenju odbora CHMP lahko vsakršno pospešenje srčnega utripa ostane zadržek, povezan s kardiovaskularnim tveganjem.
Cardiovascular safety - The CHMP had methodological concerns with regard to the quality of the data source (with dropout rates of about 40%, and lost to follow up rate above 10%) and the magnitude of the dose-dependent increase in heart rate (as heart rate measurement was not an end point in the Qsiva clinical program and no standardised methodology for accurate assessment was implemented). 
Kardiovaskularna varnost - odbor CHMP je izrazil metodološke zadržke v zvezi s kakovostjo vira podatkov (stopnja izpada preskušancev iz študije je bila približno 40 %, stopnja prekinitve sodelovanja med sledenjem pa 10 %) in obsegom pospešenja srčnega utripa, povezanega z odmerkom (ker meritev srčnega utripa ni bila opazovani dogodek v kliničnem programu z zdravilom Qsiva in niso uvedli standardizirane metodologije za natančno ocenjevanje).
In the 1 year cohort the frequency of cardiac disorders (mostly palpitations and increase in heart rate) was higher in the Qsiva groups (4.2% and 4.7% in the mid dose and high dose group, respectively) compared to placebo (1.8%). 
V enoletni kohorti je bila pogostnost srčnih bolezni (predvsem palpitacij in pospešenega srčnega utripa) večja v skupinah z zdravilom Qsiva (4,2 % v skupini s srednjim odmerkom in 4,7 % v skupini z velikim odmerkom) v primerjavi s placebom (1,8 %).
Qsiva should be prescribed by physicians experienced in the management of obesity and obesity-related co-morbidities. 
Zdravilo Qsiva naj bi predpisovali zdravniki z izkušnjami pri obravnavi debelosti in z debelostjo povezanih bolezni.
The long term cardiovascular safety of Qsiva has not been sufficiently established. 
1. dolgoročna kardiovaskularna varnost zdravila Qsiva ni bila zadovoljivo dokazana.
The overall quality of the medicinal product was considered acceptable by the CHMP. 
Odbor CHMP je presodil, da je splošna kakovost zdravila sprejemljiva.
Due to the inhibitory effect of topiramate on renal carbonic anhydrase, reductions in serum bicarbonate below 21 mEq/L were seen in 2.1%, 6.4% and 12.8% in the placebo, mid and high dose groups, and therefore are of concern in the targeted population. 
Zaradi zaviralnega učinka topiramata na ledvično karbonsko anhidrazo so zaznali znižanje ravni serumskega bikarbonata pod 21 mEq/l pri 2,1 % v skupini s placebom, 6,4 % v skupini s srednjim odmerkom in 12,8 % v skupini z največjim odmerkom, kar predstavlja zadržek za uporabo pri ciljni populaciji.
The CHMP further considered that restricting prescribing to clinical settings where prescribing decisions can be informed by a multi-disciplinary clinical team that can assess both the physical and mental health of the patients and the appropriateness of treatment with Qsiva could help minimise the risks but had concerns about the feasibility of this practice in all EU member states. 
Odbor CHMP je poleg tega presodil, da bi omejitev predpisovanja na klinična okolja, v katerih lahko odločitev za predpisovanje podkrepi večdisciplinarna klinična ekipa, ki lahko oceni telesno in duševno zdravje bolnika in ustreznost zdravljenja z zdravilom Qsiva, sicer lahko pomagala pri zmanjšanju tveganj,
The applicant's proposal to retain restricted prescribing (to physicians experienced in management of obesity and/or obesity-related co-morbidities) but to remove restricted distribution and dispensing requirements remained a concern to CHMP as this may still represent a broad prescriber base not limited to specialists. 
Za odbor CHMP ostaja vprašljiv tudi predlagateljev predlog, naj se ohrani omejeno predpisovanje zdravila (na zdravnike z izkušnjami pri zdravljenju debelosti in z debelostjo povezanih bolezni) in ukine zahteva o omejeni distribuciji in izdajanju, saj to lahko še vedno predstavlja široko bazo predpisovalcev, ki ni omejena na specialiste.
The Applicant presented hazard ratios for major cardiovascular events in Qsiva-treated subjects. 
Predlagatelj je predstavil razmerja tveganja za glavne kardiovaskularne dogodke pri preiskovancih, ki so bili zdravljeni z zdravilom Qsiva.
Pregnancies have been reported in rather high numbers in the clinical trial program raising concerns with regard to the teratogenic risk of the product when used in a less controlled real life setting. 
V programu kliničnega preskušanja so poročali o precej velikem številu nosečnosti, zato so izpostavili zadržke glede teratogenega tveganja zdravila, kadar se uporablja v manj kontroliranih okoliščinah v realnem življenju.
Dropout rates for depression with Qsiva significantly outnumbered those with placebo; thus close surveillance in trials may have stopped progression to more severe symptoms. 
Stopnje prekinitve sodelovanja preskušancev zaradi depresije ob uporabi zdravila Qsiva so bile bistveno višje kot ob uporabi placeba, zato je natančno spremljanje v preskušanjih morda preprečilo napredovanje do resnejših simptomov.
The applicant's claim that by applying the 3 month stopping rule for non-responders, the number of drop-outs due to neuropsychiatric AEs in the Qsiva group would not exceed those in the placebo group was questioned by CHMP. 
Odbor CHMP je podvomil v predlagateljevo trditev, da z uporabo pravila o prenehanju zdravljenja po 3 mesecih pri osebah, ki se ne odzivajo na zdravljenje, število prekinitev sodelovanja zaradi nevropsihiatričnih neželenih učinkov v skupini, ki je prejemala zdravilo Qsiva, ne bi preseglo števila prekinitev v skupini s placebom.
In the view of the CHMP an unmet medical need in the treatment of patients with obesity is acknowledged. 
Po mnenju odbora CHMP obstaja potreba po zdravilu za zdravljenje bolnikov s čezmerno telesno maso.
The Applicant addressed the need for effective contraception and the risk of teratogenesis in the SmPC and the RMP, which included a detailed healthcare provider checklist as well as patient education card. 
Predlagatelj je v povzetku glavnih značilnosti zdravila in načrtu za obvladovanje tveganja obravnaval potrebo po učinkoviti kontracepciji in tveganje za teratogenezo, vključno s podrobnim seznamom za izvajalca zdravstvenih storitev in informativno kartico za bolnika.
During the re-examination procedure, the applicant proposed a further revised SmPC which forgoes the top dose of Qsiva, associated with the highest rate of psychiatric and cardiovascular adverse events. 
Med postopkom ponovnega pregleda je predlagatelj predložil dodatno popravljeni povzetek glavnih značilnosti zdravila, v katerem največji odmerek zdravila Qsiva, povezan z najvišjo stopnjo psihiatričnih in kardiovaskularnih neželenih dogodkov, ni več naveden.
Therefore, the currently available cardiovascular outcome data for Qsiva was considered inconclusive and the long term cardiovascular safety of Qsiva has not been sufficiently established. 
Zato so trenutno razpoložljive podatke o kardiovaskularnih izidih pri zdravilu Qsiva upoštevali kot nedoločne, dolgoročna varnost zdravila Qsiva za srce in ožilje pa ni bila zadovoljivo dokazana.
The applicant provided with the grounds for re-examination revised Summary of Product Characteristics (SmPC) and risk management plan (RMP) proposals. 
Predlagatelj je hkrati z razlogi za ponovni pregled predložil tudi popravljena osnutka povzetka glavnih značilnosti zdravila in načrta za obvladovanje tveganja.
Phentermine's mechanism of action was a concern as it has sympathomimetic properties inducing cardiac stimulation and its use is associated with an increase in heart rate. 
Mehanizem delovanja fentermina je predstavljal zadržek zaradi svojega simpatikomimetičnega delovanja, vključno s stimulacijo srca, njegova uporaba pa je povezana s pospešenjem srčnega utripa.
Phentermine's mechanism of action is of concern as it has sympathomimetic properties inducing cardiac stimulation and its use is associated with an increase in heart rate. 
Mehanizem delovanja fentermina predstavlja zadržek zaradi svojega simpatikomimetičnega delovanja, vključno s stimulacijo srca, njegova uporaba pa je povezana s pospešenjem srčnega utripa.
Furthermore, the applicant cited the example of topiramate as further evidence that this risk can be effectively mitigated by SmPC and RMP. 
Poleg tega je predlagatelj v povzetku glavnih značilnosti zdravila in načrtu za obvladovanje tveganja navedel primer topiramata kot dodaten dokaz, da je to tveganje mogoče učinkovito omiliti.
Reduction of weight can be assumed as surrogate parameter for a beneficial cardiovascular (CV) outcome and current EMA guidance on medicinal products used in weight control does not require demonstration of a positive effect on CV morbidity and mortality prior to approval. 
trenutni napotki Evropske agencije za zdravila v zvezi z zdravili za nadzor telesne mase pa ne zahtevajo prikaza pozitivnega učinka na kardiovaskularno obolevnost in smrtnost pred odobritvijo zdravila.
The probability of off-label use - A robust SmPC and state-of-the art education-based RMP, further strengthened by the use of comprehensive prescriber checklist and patient education card, was proposed to be put in place by the applicant to be uniformly and easily implementable across all EU countries. 
ki bi ju dodatno podkrepila uporaba izčrpnega kontrolnega seznama za predpisovalca zdravila in informativne kartice za bolnika, in ki bi bila na enoten in enostaven način uvedljiva v vseh državah EU.
Overall, the availability of psychiatric expertise at sites of treatment with Qsiva was considered to be necessary by CHMP. 
V splošnem je odbor CHMP presodil, da mora biti v ustanovah, kjer se za zdravljenje uporablja zdravilo Qsiva, na razpolago možnost psihiatričnega strokovnega mnenja.
30 kg/m2) with weight-related co-morbidities such as hypertension, type 2 diabetes or dyslipidaemia. 
Zdravilo Qsiva je priporočljivo za bolnike s čezmerno telesno maso (ITM ≥ 35 kg/m2) in bolnike s čezmerno telesno maso (ITM ≥ 30 kg/m2), ki imajo zdravstvene težave, povezane s telesno maso, npr. hipertenzijo, sladkorno bolezen tipa 2 ali dislipidemijo.
The mean change from baseline to Week 108 in heart rate was also higher in the Qsiva groups (1.3 bpm and 1.7 bpm, respectively) than in the placebo group (0.4 bpm). 
108. tedna je bila večja v skupinah z zdravilom Qsiva (1,3 utripa na minuto oziroma 1,7 utripa na minuto)
The applicant presented in writing and at an oral explanation their grounds that the adopted CHMP Opinion may not have considered the data fully and also provided further analyses to support the clinical safety of Qsiva in the proposed indication. 
Razloge za ponovni pregled je predlagatelj obrazložil pisno in ustno, in sicer da mnenje odbora CHMP morda ni v celoti upoštevalo podatkov.
Therefore the cardiovascular effects of Qsiva cannot be implied from data for higher doses of phentermine as a single agent. 
Zato iz podatkov za večje odmerke fentermina pri monoterapiji ni mogoče sklepati o kardiovaskularnih učinkih zdravila Qsiva.
Obesity, including weight loss and maintenance of weight loss in adults, as an adjunct to reduced calorie diet and physical activity. 
Glede na znanstveni zaključek, ki ga je odbor CHMP sprejel 18. oktobra 2012 zdravila Qsiva ni mogoče odobriti za zdravljenje debelosti, vključno z izgubo telesne mase in vzdrževanjem izgube telesne mase pri odraslih, kot dodatek k dieti z majhnim vnosom kalorij in telesni dejavnosti.
Pregnancies have been reported in rather high numbers in the clinical trial program raising concerns with regard to the teratogenic risk of the product when used in a less controlled real life setting; 
Poleg tega kognitivni učinki take kombinacije v obdobju dolgotrajnega zdravljenja ostajajo nejasni brez ustreznih študij; 3. so v programu kliničnega preskušanja o nosečnostih poročali v precej velikem številu in izpostavili zadržke glede teratogenega tveganja zdravila, kadar se uporablja v manj kontroliranih okoliščinah v realnem življenju;
Estimates of the mean heart rate were considered by CHMP not to be necessarily the most relevant parameter (compared to e.g. increase in heart rate in the highest percentile or increased proportion of subjects with > 10 bpm) The consequence of the sympathomimetic mechanism of action of Qsiva for CV outcome in long-term use remains a principle concern for CHMP in the absence of long-term CV outcome trial data. 
Odbor CHMP je presodil, da ocene povprečnega srčnega utripa niso nujno najpomembnejši parameter (npr. v primerjavi s pospešenjem srčnega utripa v najvišjem percentilu ali s povečanim deležem preiskovancev z > 10 utripi na minuto).
The Rapporteur was Dr. Salmonson and the Co-Rapporteur was Dr Abadie. 
Poročevalec je bil dr. Salmonson, soporočevalec pa dr. Abadie.
The Reference Member State was Sweden and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Germany, Greece, Spain, Finland, France, Hungary, Ireland, Italy, Latvia, Lithuania, Luxemburg, The Netherlands, Poland, Portugal, Slovakia and United Kingdom and Norway and Iceland. 
Referenčna država članica je bila Švedska, zadevne države članice pa Avstrija, Belgija, Ciper, Češka republika, Danska, Estonija, Nemčija, Grčija, Španija, Finska, Francija, Madžarska, Irska, Italija, Latvija, Litva, Luksemburg, Nizozemska, Poljska, Portugalska, Slovaška in Združeno kraljestvo ter Norveška in Islandija.
The final opinion was converted into a Decision by the European Commission on 13 December 2006. 
Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 13. decembra 2006.
The Mutual Recognition Procedure started on 18 October 2005. 
Postopek medsebojnega priznavanja se je začel 18. oktobra 2005.
The arbitration procedure started on 27 April 2006 with the adoption of a list of questions. 
Arbitražni postopek se je začel dne 27. aprila 2006 s sprejetjem seznama vprašanj.
Sweden referred the reasons for disagreement to the EMEA on 31 March 2006. 
Švedska je svoje razloge za nestrinjanje posredovala agenciji EMEA dne 31. marca 2006.
These Member States were not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State. 
Omenjene države članice niso mogle doseči soglasja glede medsebojnega priznavanja dovoljenja za promet z zdravilom, ki ga je izdala referenčna država članica.
A positive opinion was adopted by y a majority of 19 out of 27 votes on 21 September 2006. 
Dne 21. septembra 2006 je bilo tako z večino 19 glasov od skupaj 27 sprejeto pozitivno mnenje.
The Marketing Authorisation Holder provided written explanations on 21 July 2006. 
Imetnik dovoljenja za promet je podal svoja pisna pojasnila 21. julija 2006.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Glucomed and associated names International Non-Proprietary Name (INN): glucosamine hydrochloride 
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 29(4)1 za Glucomed in z njim povezana imena Mednarodno nelastniško ime (INN): glukozaminijev hidroklorid
The applicant was asked to demonstrate efficacy of glucosamine in the intended indication “relief of symptoms in mild to moderate osteoarthritis of the knee”. 
Od predlagatelja so zahtevali, da dokaže učinkovitost glukozamina pri predvideni indikaciji “lajšanje simptomov blagega do zmernega osteoartritisa kolena”.
In addition the applicant was asked to justify the proposed dose and posology, to characterise the safety profile, including a discussion of reported adverse drug reactions, to justify the relevance of literature considering that the formulations of glucosamine sulphate (as the sodium chloride complex) used in the cited literature differ from the concerned application formulation and whether the differences in formulation will alter the efficacy and safety of the product, to elucidate the possibility of interactions with other medicinal products, and finally to show a positive risk/benefit profile of glucosamine hydrochloride in the intended indication. 
Poleg tega so predlagatelja tudi zaprosili, da utemelji predlagani odmerek in način odmerjanja, opredeli varnostni profil zdravila, vključno z razpravo o opaženih neželenih učinkih zdravila, utemelji relevantnost literature, ker formulacije glukozaminijevega sulfata (v obliki kompleksa z natrijevim kloridom), uporabljene v citirani literaturi, niso enake zadevni formulaciji za uporabo zdravila ter navede, ali bodo razlike v formulaciji vplivale na učinkovitost in varnost zdravila, opredeli možnost interakcij z drugimi zdravili in končno tudi dokaže pozitivno razmerje med koristmi in tveganji uporabe glukozaminijevega hidroklorida pri predvideni indikaciji.
The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics, labelling and package leaflet in Annex III. 
Seznam zadevnih imen tega zdravila je podan v Dodatku I, znanstveni zaključki pa v Dodatku II, skupaj s Povzetkom glavnih značilnosti zdravila, označevanjem in navodili za uporabo v Dodatku III.
Glucosamine was mainly introduced on the world-wide market as a foodsupplement but with the aim to improve symptoms in patients with osteoarthritis or joint pain or function. 
Glukozamin so začeli tržiti po vsem svetu kot prehransko dopolnilo, vendar z namenom lajšanja simptomov pri bolnikih z osteoartritisom ali bolečin v sklepih ali z namenom izboljšanja funkcije sklepov.
During their September 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Glucomed and associated names for the relief of symptoms in mild to moderate osteoarthritis of the knee, that there was no objection for the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State 
Na sestanku v septembru 2006 je bil CHMP ob upoštevanju vseh predloženih podatkov in znanstvene razprave v okviru Odbora mnenja, da je razmerje med koristmi in tveganji za zdravilo Glucomed in z njim povezana imena za lajšanje simptomov blagega do zmernega osteoartritisa kolena ugodno, da ni nikakršnih zadržkov za izdajo dovoljenja za promet z zdravilom in da je treba Povzetek glavnih
Glucomed and associated names, 625 mg, tablet, contains glucosamine which is an endogenous substance, a normal constituent of the polysaccharide chains of cartilage matrix and synovial fluid glucosaminoglycans. 
Zdravilo Glucomed in z njim povezana imena, 625 mg tablete, vsebujejo glukozamin, ki je endogena snov in je običajen gradnik polisaharidnih verig v hrustančnem matriksu in glikozaminoglikanov v sinovijski tekočini.
Navamedic ASA submitted applications for mutual recognition of Glucomed and associated names, 625 mg, tablet on the basis of the marketing authorisation granted by Sweden on 4 August 2005. 
Na podlagi dovoljenja za promet z zdravilom, izdanega na Švedskem 4. avgusta 2005, je družba Navamedic ASA podala vloge za medsebojno priznavanje zdravila Glucomed in z njim povezanih imen, 625 mg tablete.
This summary was last updated in: 04-2013. 
Ta povzetek je bil nazadnje posodobljen 04-2013.
Immunity starts after three weeks and lasts for three months. 
Imunost se razvije po treh tednih in traja tri mesece.
This can be up to 2 cm in diameter after first injection and up to 5 cm after the second, but they usually disappear within three weeks. 
Po prvi injekciji lahko v premeru meri do 2 cm, po drugi injekciji pa do 5 cm, vendar navadno izgine v treh tednih.
The antibodies are also passed on from mother to piglet through the colostrums (first milk) and milk. 
Protitelesa se od samice na pujska prenašajo tudi prek kolostruma (prvega mleka) in mleka.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a diseases. 
Cepiva delujejo tako, da imunski sistem (naravno obrambo telesa) naučijo, kako naj se brani pred boleznijo.
Wash and disinfect hands and equipment after use. 
Po uporabi si operite in razkužite roke ter opremo.
The vaccine also contains ‘adjuvants' (a compound containing aluminium as well as mineral oil, an emulsifier and a detergent) to stimulate a better response. 
Cepivo vsebuje tudi adjuvans (spojino, ki vsebuje aluminij, mineralno olje, emulgator in detergent) za stimulacijo boljšega odziva.
Accidental injection can cause severe pain and swelling, particularly if the vaccine is injected into a joint or finger. 
Nenamerno injiciranje lahko povzroči hudo bolečino in oteklino, še zlasti v primeru nenamernega injiciranja v sklep ali prst.
This protects the pigs against the disease. 
To pomaga zaščititi prašiče pred boleznijo.
Breeding boars (male pigs) should be revaccinated every six months. 
Plemenske merjasce (samce) je treba ponovno cepiti vsakih šest mesecev.
It prevents death and symptoms of the disease and reduces the shedding of the virus. 
Cepivo preprečuje pogin in simptome bolezni ter zmanjšuje izločanje virusa.
Female breeding pigs should be revaccinated before their first mating or during each pregnancy, three to six weeks before giving birth. 
Plemenske samice je treba ponovno cepiti pred prvim parjenjem ali med vsako brejostjo, tri do šest tednov pred skotitvijo.
The virus has been genetically modified: it has had one of its gene deleted (the gene that makes it able to produce an enzyme called thymidine kinase) and this is what makes it weaker. 
Virus je bil gensko spremenjen: odstranjen je bil eden izmed genov (gen, ki omogoča tvorjenje encima timidin kinaza), zato je virus šibkejši.
To vaccinate a whole herd, one dose should be given to every male and female breeding pig every four months. 
Za cepljenje cele črede se priporoča dajanje enega odmerka vsakemu plemenskemu samcu in samici vsake štiri mesece.
The studies compared the levels of infection in vaccinated and unvaccinated pigs. 
V raziskavah so primerjali stopnjo okužbe pri cepljenih in necepljenih prašičih.
When a pig is given the vaccine, the immune system recognises the weakened viruses as ‘foreign' and makes antibodies against them. 
Ko prašič prejme cepivo, imunski sistem prepozna oslabljene viruse kot tujke in proti njim razvije protitelesa.