natgillin/translations-raw huggingface dataset:
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EUROPEAN MEDICINES AGENCY 
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
The wording concerning QT prolongation and 5-HT3 antagonists has been reviewed and approved as part of the Article 46 procedure, and the approved wording regarding QTc prolongation has been included in section 4.5 as well as in sections 4.4 and 4.8. 
Besedilo v zvezi s podaljšanjem intervala QT in antagonisti 5-HT3 je bilo pregledano in odobreno kot del postopka v skladu s členom 46, potrjeno besedilo glede podaljšanja intervala QTc pa je bilo vključeno v poglavje 4.5 ter v poglavji 4.4 in
There are no studies in pregnant women and it is not known whether Kytril is excreted in human milk. 
Pri nosečnicah niso bile izvedene nobene študije in ni znano, ali se zdravilo Kytril izloča v človeško mleko.
Section 4.7 - Effects on ability to drive and use machines The proposed SmPC text reflects the recommendations regarding section 4.7 in the European SmPC guideline. 
Poglavje 4.7 - Vpliv na sposobnost vožnje in upravljanja s stroji Predlagano besedilo povzetka glavnih značilnosti zdravila odraža priporočila v zvezi s poglavjem 4.7 v evropski smernici za povzetek glavnih značilnosti zdravila.
The CHMP considered the MAH's proposed wording in section 5.2 to be acceptable with the addition that the pharmacokinetics of oral administration is linear up to 2.5-fold of the recommended dose in adults and also that the plasma concentration does not correlate unequivocally with the antiemetic efficacy of the substance for both the tablets and solution for injection formulations. 
CHMP je menil, da je predlagano besedilo imetnika dovoljenja za promet z zdravilom za poglavje 5.2 sprejemljivo z dopolnitvijo, da je farmakokinetika pri peroralni uporabi linearna do 2,5kratnega priporočenega odmerka pri odraslih ter da plazemska koncentracija ni jasno povezana z antiemetično učinkovitostjo snovi tako pri formulaciji tablet kot pri formulaciji raztopine za injiciranje.
In response to the LoOI the MAH discussed their own safety data as well as data in published trials and well known databases, and it was agreed that extrapyramidal reactions would be included as an adverse event in section 4.8 of the SmPC. 
V odgovorih na seznam nerešenih vprašanj je imetnik dovoljenja za promet z zdravilom obravnaval tako lastne podatke o varnosti kot tudi podatke iz objavljenih preskušanj in dobro znanih podatkovnih zbirk in dogovorjeno je bilo, da se ekstrapiramidalne reakcije vključijo kot neželeni učinek v poglavje 4.8 povzetka glavnih značilnosti zdravila.
In addition following further CHMP discussion, diarrhoea, (frequently reported adverse event in the pooled studies 276 and 278 and in the integrated summary of safety) and elevations in hepatic transaminases (observed in the CDS) were also included as adverse reactions. 
Po nadaljnji razpravi v CHMP sta bila med neželene učinke vključena tudi driska (neželeni učinek, o katerem so pogosto poročali v združenih študijah 276 in 278 ter v celostnem povzetku varnosti) in zvišanje jetrnih transaminaz (opaženo na podatkovnem listu s temeljnimi podatki).
Section 4.5- Interaction with other medicinal products and other forms of interaction There is a need to apply caution when giving medication, which is known to prolong the QT interval, concurrently with 5-HT3 antagonists such as Kytril. 
Poglavje 4.5 - Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Pri dajanju zdravila, za katero je znano, da podaljšuje interval QT, sočasno z antagonisti 5-HT3, kot je zdravilo Kytril, je potrebna previdnost.
The CHMP also endorsed the proposal that caution should be exercised in patients with cardiac comorbidities or cardiotoxic chemotherapy and/or concomitant electrolyte abnormalities. 
CHMP je potrdil tudi predlog, da je potrebna previdnost pri bolnikih s sočasnimi srčnimi obolenji, bolnikih, ki prejemajo kardiotoksično kemoterapijo, in/ali bolnikih s sočasnimi elektrolitskimi motnjami.
Based on the presented data the CHMP agreed that the use of Kytril should preferably be avoided during pregnancy. 
Na podlagi predstavljenih podatkov je CHMP potrdil, da se je med nosečnostjo bolje izogibati uporabi zdravila Kytril.
Based on the evidence provided, the use of Kytril in PONV was restricted to the solution for injection formulation only. 
Na podlagi predloženih dokazov je bila uporaba zdravila Kytril pri PONV omejena samo na formulacijo raztopine za injiciranje.
Several in vitro and in vivo studies did not show that Kytril had a genotoxic effect on mammalian cells. 
Več študij in vitro ter in vivo ni pokazalo nobenega genotoksičnega učinka zdravila Kytril na celice sesalcev.
Section 4.4 - Special warnings and precautions for use As it is well-known that 5-HT3 antagonists lower bowel motility, which is reflected in the literature, the CHMP endorsed the MAH's proposal that patients with signs of sub-acute intestinal obstruction should be monitored following administration of Kytril. 
Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi Ker je dobro znano, da antagonisti 5-HT3 zmanjšujejo gibljivost črevesja, kar je razvidno tudi iz literature, je CHMP potrdil predlog imetnika dovoljenja za promet z zdravilom, da je treba bolnike s subakutno obstrukcijo črevesja po uporabi zdravila Kytril spremljati.
The SmPC wording regarding QT prolongation has been agreed through the Article 46 procedure as follows “As for other 5-HT3 antagonists, ECG changes including QT prolongation have been reported with Kytril (See sections 4.4 and 4.5).” The CHMP endorsed the MAH's proposal to place QT-prolongations as a description of selected adverse events, because the ECG modifications including the QT-prolongation seen were minor and generally not of clinical significance. 
Besedilo o podaljšanju intervala QT v povzetku glavnih značilnosti zdravila je bilo potrjeno s postopkom v skladu s členom 46 in se glasi: „Kot pri drugih antagonistih 5-HT3 so tudi pri uporabi zdravila Kytril poročali o spremembah EKG, vključno s podaljšanjem intervala QT (glejte poglavji 4.4 in 4.5).“ CHMP je potrdil predlog imetnika dovoljenja za promet z zdravilom, da se podaljšanje intervala QT vključi v opis izbranih neželenih učinkov, saj so bile opažene spremembe EKG, vključno s podaljšanjem intervala QT, manj pomembne in na splošno brez kliničnega pomena.
Solution for injection: ‘Kytril solution for injection is indicated in adults for the prevention and treatment of 
Raztopina za injiciranje: „Raztopina za injiciranje Kytril je indicirana pri odraslih za preprečevanje in zdravljenje
Taking into account the recommendation of the CHMP and the MAH's proposals, the following wording was agreed for the indication in adults, for the following pharmaceutical forms - tablets and solution for injection: 
Ob upoštevanju priporočil CHMP in predlogov imetnika dovoljenja za promet z zdravilom je bilo za farmacevtski obliki - tablete in raztopina za injiciranje - usklajeno naslednje besedilo za indikacijo pri odraslih:
It was also endorsed by the CHMP that insomnia should be included in the SmPC as an adverse event, since it occurs with a frequency greater than 2 % compared with placebo, in the clinical study 285. 
CHMP je tudi potrdil, da je treba v povzetek glavnih značilnosti zdravila kot neželeni učinek vključiti nespečnost, saj se v klinični študiji 285 pojavlja s pogostnostjo, ki je v primerjavi s placebom večja za 2 %.
The SmPC has not included cross-sensitivity reactions as a contraindication for Kytril , but instead included appropriate wording in the warnings and precautions section (section 4.4) of the EU harmonised SmPC. 
V povzetek glavnih značilnosti zdravila Kytril kot kontraindikacija niso bile vključene reakcije navzkrižne občutljivosti, namesto tega pa je bilo ustrezno besedilo dodano v poglavje z opozorili in previdnostnimi ukrepi (poglavje 4.4) usklajenega povzetka glavnih značilnosti zdravila na ravni EU.
The terms hypersensitivity (e.g. anaphylaxis, urticaria) and constipation were included in the proposed SmPC as they are included in the majority of SmPCs, and are also supported by referenced texts and the CDS. 
Izraza preobčutljivost (na primer anafilaksa, urtikarija) in zaprtje sta bila vključena v predlagani povzetek glavnih značilnosti zdravila, saj sta vključena v večino povzetkov glavnih značilnosti zdravila, potrjujejo pa ju tudi referenčna besedila in podatkovni list s temeljnimi podatki.
The use of granisetron orally in PONV is not recommended. 
Peroralna uporaba granisetrona pri PONV ni priporočljiva.
Further evidence provided by the MAH support the use of granisetron only in the prevention of delayed CINV and RINV, and not in the treatment of delayed CINV and RINV for both formulations. 
Nadaljnji dokazi, ki jih je predložil imetnik dovoljenja za promet z zdravilom, prav tako podpirajo uporabo granisetrona samo pri preprečevanju zakasnele CINV in RINV, ne pa tudi pri zdravljenju zakasnele CINV in RINV za obe formulaciji.
• the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet 
• Namen napotitve je bila uskladitev povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo.
Based on the theoretical possibility of cross-sensitivity reactions with granisetron, the MAH has proposed to include cautionary wording in this section of the SmPC. 
Na podlagi teoretične možnosti za pojav reakcij navzkrižne občutljivosti ob uporabi granisetrona je imetnik dovoljenja za promet z zdravilom predlagal vključitev opozorilnega besedila v to poglavje povzetka glavnih značilnosti zdravila.
There was insufficient evidence for the adverse events agitation, anxiety, arrhythmias, chest pain, coma, dizziness, dysgeusia, hypotension/hypertension, syncope and/or drowsiness/ somnolence, anorexia, nausea, vomiting, abdominal pain, fever, fatigue and weakness/asthenia/tiredness, flulike symptoms, oedema and pain in patients treated with Kytril and the CHMP therefore concurred that these terms could be excluded from the SmPC. 
Ker ni bilo zadostnih dokazov, na podlagi katerih bi bilo pri bolnikih, zdravljenih z zdravilom Kytril, kot neželene učinke mogoče potrditi vznemirjenost, tesnobo, aritmije, bolečine v prsih, komo, omotico, disgevzijo, hipotenzijo/hipertenzijo, sinkopo in/ali dremavost/zaspanost, anoreksijo,
Considering the lack of data for dystonia, the CHMP agreed with MAH not to include this undesirable effect in the proposed SmPC at this point in time. 
Zaradi pomanjkanja podatkov v zvezi z distonijo se je CHMP strinjal z imetnikom dovoljenja za promet z zdravilom, da se v tem trenutku ta neželeni učinek ne vključi v predlagani povzetek glavnih značilnosti zdravila.
Following a review of the available data, the MAH has concluded that the use of Kytril orally in PONV should not be recommended, which was supported by the CHMP. 
Po pregledu razpoložljivih podatkov je imetnik dovoljenja za promet z zdravilom sklenil, da peroralna uporaba zdravila Kytril pri PONV ni priporočljiva, kar je potrdil tudi CHMP.
Based solely on the hypersensitivity reaction, the CHMP agreed that rash should also be listed. 
Zgolj na podlagi reakcije preobčutljivosti je CHMP potrdil, da se na seznam vključijo tudi izpuščaji.
This is consistent with the recommendations and wording of the SmPC guideline. 
Besedilo je v skladu s priporočili in besedilom smernice za povzetek glavnih značilnosti zdravila.
There is insufficient clinical evidence to recommend administration of Kytril solution for injection to children in the prevention and treatment of RINV and PONV. 
Ni zadostnih kliničnih dokazov, na podlagi katerih bi bilo mogoče priporočiti uporabo raztopine za injiciranje Kytril pri otrocih za preprečevanje in zdravljenje RINV in PONV.
However as agreed by the CHMP, the administration of Kytril solution for injection is recommended in children aged 2 years and above, only for the prevention and treatment of acute CINV. 
Vendar pa je CHMP potrdil, da je uporaba raztopine za injiciranje Kytril priporočena za uporabo pri otrocih, starih dve leti in več, vendar samo za preprečevanje in zdravljenje akutne CINV.
Based on the available data, the indication for Kytril solution for injection in the treatment and prevention of delayed CINV was not agreed by the CHMP. 
Na podlagi razpoložljivih podatkov CHMP ni potrdil indikacije za zdravljenje in preprečevanje zakasnele CINV za raztopino za injiciranje Kytril.
Tablets: ‘Kytril film-coated tablets are indicated in adults for the prevention and treatment of acute nausea and vomiting associated with chemotherapy and radiotherapy. 
Tablete: „Filmsko obložene tablete Kytril so indicirane pri odraslih za preprečevanje in zdravljenje akutnih slabosti in bruhanja, povezanih s kemoterapijo in radioterapijo.
Therefore the following paediatric indication was agreed by the CHMP, only for Kytril solution for injection: ‘Kytril solution for injection is indicated in children aged 2 years and above for the prevention and treatment of acute nausea and vomiting associated with chemotherapy.' 
Tako je CHMP potrdil naslednjo pediatrično indikacijo samo za raztopino za injiciranje Kytril: „Raztopina za injiciranje Kytril je indicirana pri otrocih, starih 2 leti in več, za preprečevanje in zdravljenje akutnih slabosti in bruhanja, povezanih s kemoterapijo.“ Poglavje 4.2 - Odmerjanje in način uporabe
Kytril solution for injection is indicated for the prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy.' 
Raztopina za injiciranje Kytril je indicirana za preprečevanje zakasnelih slabosti in bruhanja, povezanih s kemoterapijo in radioterapijo.“
Harmonisation of the existing SmPCs relating to the clinical sections, for Kytril film-coated tablets and solutions for injection, are discussed below: 
Uskladitev obstoječih povzetkov glavnih značilnosti zdravila v zvezi s kliničnimi poglavji za zdravilo Kytril, filmsko obložene tablete in raztopine za injiciranje, je predstavljena v nadaljevanju: Poglavje 4.1 - Terapevtske indikacije
The CHMP recommendation that Kytril should be used with a certain amount of caution in hepatically impaired patients was also included by the MAH. 
Imetnik dovoljenja za promet z zdravilom je vključil tudi priporočilo CHMP, da je treba zdravilo Kytril pri bolnikih z jetrno okvaro uporabljati z nekaj previdnosti.
There is insufficient clinical experience to recommend administration of Kytril tablets to children for CINV, RINV or PONV. 
Trenutno ni zadostnih kliničnih izkušenj, na podlagi katerih bi bilo mogoče priporočiti uporabo tablet Kytril pri otrocih s CINV, RINV ali PONV.
-acute nausea and vomiting associated with chemotherapy and radiotherapy. 
- akutnih slabosti in bruhanja, povezanih s kemoterapijo in radioterapijo; - pooperacijskih slabosti in bruhanja.
The CHMP endorsed the treatment and prevention of acute CINV and RINV for both formulationstablets and injection for solution. 
CHMP je potrdil zdravljenje in preprečevanje akutne CINV (s kemoterapijo povzročeni slabost in bruhanje) in RINV (z radioterapijo povzročeni slabost in bruhanje) za obe formulaciji - tablete in raztopino za injiciranje.
The MAH also proposed to include ‘rash' as an adverse drug reaction with an uncommon frequency. 
Imetnik dovoljenja za promet z zdravilom je predlagal tudi, da se med neželene učinke zdravila z občasno pogostnostjo vključijo „izpuščaji“.
Based on data provided by MAH, the intramuscular route of administration was not considered to be acceptable by the CHMP. 
Na podlagi podatkov, ki jih je predložil imetnik dovoljenja za promet z zdravilom, je CHMP menil, da intramuskularna uporaba ni sprejemljiva.
• the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Kytril and associated names (see Annex I). 
• Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki jih je predlagal imetnik dovoljenja za promet, so bili ocenjeni na osnovi predložene dokumentacije in strokovne razprave v Odboru.
Kytril film-coated tablets are indicated in adults for prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy.' 
Filmsko obložene tablete Kytril so indicirane pri odraslih za preprečevanje zakasnelih slabosti in bruhanja, povezanih s kemoterapijo in radioterapijo.“
The clinical data have not been considered substantial enough to support the use of Kytril for RINV or PONV in paediatric patients. 
Klinični podatki niso bili dovolj pomembni, da bi podprli uporabo zdravila Kytril pri pediatričnih bolnikih z RINV ali PONV.
At the request of the CHMP the MAH re-submitted the reproductive data and an updated Nonclinical Overview. 
Poglavje 5.3 - Predklinični podatki o varnosti Na zahtevo CHMP je imetnik dovoljenja za promet z zdravilom ponovno predložil podatke o reprodukciji in posodobljeni neklinični pregled.
The MAH's proposal not to include hypothetical symptoms listed in a minority of SmPC, but to remain consistent with wording provided in the CDS was accepted by the CHMP. 
CHMP je sprejel predlog imetnika dovoljenja za promet z zdravilom, da se hipotetični simptomi, ki so bili navedeni v manjšem številu povzetkov glavnih značilnosti zdravila, ne vključijo, in da se ohrani skladnost z besedilom na podatkovnem listu s temeljnimi podatki.
The MAH also proposed Kytril solution for injection in children aged 2 years and above for the prevention and treatment of acute CINV, which was accepted by the CHMP. 
Imetnik dovoljenja za promet z zdravilom je tudi predlagal, da se raztopina za injiciranje Kytril lahko uporablja za preprečevanje in zdravljenje akutne CINV pri otrocih, starih dve leti in več, kar je CHMP potrdil.
The SmPC does not recommend administration of Kytril solution for injection for paediatric use in RINV and PONV. 
V povzetku glavnih značilnosti zdravila ni priporočena uporaba raztopine za injiciranje Kytril za pediatrično uporabo pri RINV in PONV.
Section 4.2 - Posology and method of administration The harmonised proposed text proposed by the MAH was accepted by the CHMP for both the tablets and solution for injection. 
Usklajeno predlagano besedilo, ki ga je predložil imetnik dovoljenja za promet z zdravilom, je CHMP potrdil za tablete in raztopino za injiciranje.
--1 Rabies virus, strain SPBN GASGAS, live - 106.8 to 108.1 FFU* per 1.7 ml dose * Focus forming units 
--1 Cepivo proti steklini, sev SPBN GASGAS, živo - 10
• The Committee considered the (Co-)Rapporteur's assessment report; 
• odbor je upošteval poročilo o oceni (so-)poročevalca,
In addition, the applicant refers to relevant clinical guidelines. 
Poleg tega se predlagatelj sklicuje na ustrezne klinične smernice.
This specific dose is also supported by bibliographical evidence submitted by the applicant. 
Ta odmerek podpirajo tudi bibliografski dokazi, ki jih je predložil predlagatelj.
• The Committee considered the referral under Article 29(4) of Directive 2001/83/EC where Germany raised objections as a potential serious risk to public health; 
• odbor je obravnaval napotitev v skladu s členom 29(4) Direktive 2001/83/ES, pri čemer je Nemčija izrazila pomisleke zaradi morebitnega resnega tveganja za javno zdravje,
However, according to Notice to Applicants Volume 2A Chapter 1 Section 5.51 , a mixed-dossier can be accepted. 
V skladu z Obvestilom predlagateljem, zvezek 2A, poglavje 1, oddelek 5.51, pa se lahko sprejme mešana dokumentacija.
This referral procedure concerns the products in UK, AT and DE. 
Ta napotitveni postopek se nanaša na zdravila v Združenem kraljestvu, Avstriji in Nemčiji.
According to Article 10b of Directive 2001/83/EC, new clinical or non-clinical trials relating to the combination (although not the individual active substances) should be submitted. 
V skladu s členom 10b Direktive 2001/83/ES je treba predložiti rezultate novih kliničnih ali nekliničnih preskušanj, ki se nanašajo na to kombinacijo (ne pa tudi na posamezne učinkovine).
The applicant has submitted a review of the literature relating to the use of diclofenac and omeprazole in combination. 
Predlagatelj je predložil pregled literature, ki se nanaša na uporabo diklofenaka in omeprazola v kombinaciji.
DE is in agreement with the CHMP conclusion. 
Nemčija se strinja z zaključkom odbora CHMP.
A decentralised procedure (DCP) with the UK as reference Member State (RMS) and AT, EE, LT, LV and MT as CMSs, concluded positively on 7 November 2016 (UK/H/6135/001/DC). 
Decentralizirani postopek, pri katerem je bila referenčna država članica Združeno kraljestvo, Avstrija, Estonija, Litva, Latvija in Malta pa zadevne države članice, se je pozitivno končal 7. novembra 2016 (UK/H/6135/001/DC).
Data from studies of higher doses of diclofenac or other NSAIDs can be extrapolated to support the efficacy and safety of the specific combination. 
Podatki iz študij z večjimi odmerki diklofenaka ali drugih NSAID se lahko uporabijo za sklepanje na varnost in učinkovitost te točno določene kombinacije.
It is noted that the bioequivalence has been demonstrated between the free combination of the recognised reference formulations of the individual mono-components and the proposed fixed combination product and there are no outstanding concerns regarding quality and non-clinical issues. 
Poudariti je treba, da je bila dokazana bioekvivalenca med prosto kombinacijo priznanih referenčnih formulacij posameznih monokomponent in predlaganim zdravilom s fiksno kombinacijo ter da ni nerazrešenih pomislekov, kar zadeva kakovost in neklinične vidike.
However, the position of DE was that this particular combination of diclofenac/omeprazole in the specific doses 75 mg / 20 mg administered once daily has never been tested in any published study and no new clinical data has been generated. 
Stališče Nemčije pa je, da točno ta kombinacija diklofenaka/omeprazola v točno določenih odmerkih 75 mg/20 mg, ki se daje enkrat dnevno, še nikoli ni bila preskušena v nobeni objavljeni študiji in niso bili ustvarjeni nobeni novi klinični podatki.
However, the CHMP took into consideration the Guideline on clinical development of fixed combination medicinal products2 and concluded by consensus that the development of Diotop 75 mg/20 mg is in line with it, since the Guideline does not preclude extrapolation from higher doses and different substances if scientifically justified. 
Vendar je odbor CHMP upošteval Smernice o kliničnem razvoju zdravil s fiksno kombinacijo2 in zaključil, da se razvoj zdravila Diotop 75 mg/20 mg z njimi sklada, saj te smernice ne izključujejo sklepanja na podlagi večjih odmerkov in drugih snovi, če je to znanstveno upravičeno.
Moreover the mechanisms for both NSAID-associated GI toxicity and the gastro-protective efficacy of omeprazole are not expected to differ across the different non-selective NSAIDs studied, which are all associated with a risk of upper GI complications. 
Poleg tega se mehanizmi z NSAID povezane gastrointestinalne toksičnosti in gastroprotektivne učinkovitosti omeprazola med različnimi proučevanimi neselektivnimi NSAID, ki so vsi povezani s tveganjem za zaplete v zgornjih prebavilih, medsebojno ne bi smeli razlikovati.
Bioequivalence has been demonstrated between Diotop 75 mg / 20 mg and the free combination of the recognised reference formulations of the individual mono-components. 
Dokazana je bila bioekvivalenca med zdravilom Diotop 75 mg/20 mg in prosto kombinacijo priznanih referenčnih formulacij posameznih monokomponent.