natgillin/translations-raw huggingface dataset:
The CHMP noted that the Applicant had received scientific advice from the CHMP on the clinical program, stating that for locally applied, locally acting products containing known constituents, an in vitro approach could in principle be used for demonstration of equivalence, provided that this approach is justified. 
CHMP je ugotovil, da je predlagatelj prejel znanstven nasvet CHMP glede kliničnega programa, v katerem je navedeno, da je za dokaz enakovrednosti lokalno nanesenih in lokalno delujočih zdravil z znanimi sestavinami načeloma možno uporabiti pristop in vitro pod pogojem, da je ta pristop utemeljen.
In addition, the objecting CMS raised concerns regarding the statistical methodology applied. 
Poleg tega je nasprotujoča zadevna država članica sprožila zadržek glede uporabljene statistične metodologije.
The Applicant submitted an application for Mometasone Furoate Sandoz 50 mcg/dose, in the treatment of the symptoms of seasonal allergic or perennial rhinitis and of nasal polyps, as a nasal spray with two different spray pump devices (Device 1 and Device 2). 
Predlagatelj je predložil vlogo za zdravilo Mometasone Furoate Sandoz 50 mcg/odmerek za zdravljenje simptomov sezonskega alergijskega ali celoletnega rinitisa in nosnih polipov v obliki pršila za nos z dvema različnima pripomočkoma s pršilno črpalko (pripomoček 1 in pripomoček 2).
The CHMP considered that this was supported by the evidence of equivalent therapeutic efficacy obtained from the phase III clinical study comparing the proposed product with the Device 1 spray pump and the reference product. 
CHMP je menil, da to podpira dokaz enakovredne terapevtske učinkovitosti iz klinične študije III. faze, v kateri so primerjali predlagano zdravilo s pršilno črpalko pripomočka 1 in referenčno zdravilo.
The Applicant provided in vitro data for both devices, however only Device 1 was investigated in vivo. 
Predlagatelj je predložil podatke in vitro za oba pripomočka, vendar so in vivo preverili le pripomoček 1.
The objecting CMS considered that the available in vitro data is not a valid surrogate for the equivalence of the products, as the comparison was performed using the Population Bioequivalence (PBE) method, which consists of an aggregate criterion where the differences in means can be compensated by the differences in variability. 
Nasprotujoča država članica je menila, da razpoložljivi podatki in vitro niso veljaven nadomestek enakovrednosti zdravil, saj je bila primerjava opravljena z metodo populacijske biološke enakovrednosti (PBE), ki vsebuje združeno merilo, v katerem se lahko razlike v povprečju kompenzirajo z razlikami v variabilnosti.
This was further supported by the clinical data obtained with the Device 1 spray pump. 
To podpirajo še klinični podatki, dobljeni s pršilno črpalko pripomočka 1.
Because of the low systemic bioavailability and the poor absorption from the gastrointestinal tract of mometasone furoate, the Applicant decided not to perform any pharmacokinetic or pharmacodynamic studies and instead performed comparative in vitro studies between the proposed and the reference products for both spray pump delivery devices. 
Zaradi majhne sistemske biološke uporabnosti mometazonfuroata in njegove slabe absorpcije iz prebavil se je predlagatelj odločil, da ne bo opravil farmakokinetičnih ali farmakodinamičnih študij, ampak primerjalne študije in vitro s predlaganim in referenčnim zdravilom za oba pripomočka za vnos s pršilno črpalko.
While the reference member state considered both devices to be approvable, the objecting concerned member state (CMS) did not consider in vitro data to be a valid surrogate of equivalence for nasal suspensions and therefore considered that equivalence had not been demonstrated for Device 2. 
Čeprav je bila referenčna država članica mnenja, da je mogoče odobriti oba pripomočka, je nasprotujoča zadevna država članica menila, da podatki in vitro niso veljaven nadomestek enakovrednosti suspenzij za nos in da za pripomoček 2 enakovrednost ni bila dokazana.
Having assessed the entirety of the available data, the CHMP concluded that the evidence of comparable particle size distribution as well as location and pattern of deposition between the proposed and the reference products indicates comparable dissolubility, which is in turn an indicator of comparable safety and efficacy. 
CHMP je po oceni vseh razpoložljivih podatkov zaključil, da dokazi primerljivosti porazdelitve velikosti delcev ter lokacije in vzorcev nanosa med predlaganima zdraviloma in referenčnim zdravilom kažejo primerljivo topnost, ki je pokazatelj primerljive varnosti in učinkovitosti.
• the CHMP considered that the results of the conducted in vitro comparisons confirm that the particle size distribution as well as the locations and patterns of deposition of the suspension in the nose of the proposed products and the reference product are comparable, 
• CHMP je menil, da rezultati opravljenih primerjav in vitro potrjujejo, da so porazdelitev velikosti delcev ter lokacije in vzorci nanosa suspenzije v nos predlaganih zdravil in referenčnega zdravila primerljivi;
As the CHMP considered the rate of dissolution to determine the availability of the active substance locally, the CHMP further concluded that the data confirmed that potential differences between the proposed and the reference products would not impact the benefit-risk of the proposed products. 
CHMP je za določanje lokalne uporabnosti zdravilne učinkovine upošteval hitrost raztapljanja, zato je zaključil, da podatki potrjujejo, da možne razlike med predlaganima zdraviloma in referenčnim zdravilom ne bodo vplivale na razmerje koristi in tveganj predlaganih zdravil.
In conclusion, considering the total body of available evidence, the CHMP considered it to be adequately demonstrated that potential differences between the proposed product fitted either with the Device 1 pump or with the Device 2 pump and the reference product do not affect the safety and efficacy of the proposed products and that the benefit-risk of the proposed products is therefore positive. 
Torej, CHMP je po upoštevanju vseh razpoložljivih podatkov menil, da je zadostno dokazano, da možne razlike med predlaganim zdravilom, opremljenim bodisi s črpalko pripomočka 1 bodisi s črpalko pripomočka 2, ter referenčnim zdravilom ne vplivajo na varnost in učinkovitost predlaganih zdravil ter da je zato razmerje koristi in tveganj predlaganih zdravil pozitivno.
• the CHMP considered the benefit-risk of the proposed products to be positive, the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Mometasone Furoate Sandoz and associated names (see Annex I). 
je CHMP priporočil odobritev dovoljenja za promet z zdravilom, za katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostajajo enaki kot končne različice, dogovorjene med postopkom Usklajevalne skupine, kot je navedeno v
The PBE method may therefore be more permissive than the Average Bioequivalence (ABE) method described in the CHMP's Guideline on the Requirements for Clinical Documentation for Orally Inhaled Products (OIP).1 While noting that the Applicant had presented justifications for the use of PBE and that this use was pre-specified where 
Metoda PBE bi lahko tako bila popustljivejša kot metoda povprečne biološke enakovrednosti (ABE), ki je opisana v Smernici odbora CHMP o zahtevah za klinično dokumentacijo za peroralno inhalirana zdravila (OIP).
applied, the CHMP considered that the use of PBE in bioequivalence studies is not desirable as it may lead to the acceptance of higher levels of variability between drug products. 
Čeprav je ugotovil, da je predlagatelj predložil utemeljitve uporabe metode PBE in da je bila ta metoda, kjer je bila uporabljena, v naprej določena, je CHMP menil, da uporaba metode PBE v študijah biološke enakovrednosti ni zaželena, saj lahko privede do sprejema višjih ravni variabilnosti med zdraviloma.
Having assessed the performance of the spray pumps and the properties of the suspension in the spray, the CHMP agreed that there is adequate evidence of comparable particle size distribution of the active substance suspension between the proposed products and reference product, and also agreed that comparable locations and patterns of deposition were demonstrated. 
CHMP je ocenil zmogljivost pršilnih črpalk in lastnosti suspenzije v pršilu ter se strinjal, da obstajajo zadostni dokazi primerljivosti porazdelitve velikosti delcev suspenzije zdravilne učinkovine med predlaganima zdraviloma in referenčnim zdravilom.
• the CHMP considered particle size distribution and location and pattern of deposition to be adequate indicators of dissolubility and therefore concluded that the proposed and the reference products have comparable dissolution properties, 
• CHMP je menil, da so porazdelitev velikosti delcev ter lokacija in vzorec nanosa zadostni pokazatelji topnosti, in zato zaključil, da imata predlagano in referenčno zdravilo primerljive topnostne lastnosti; • CHMP je zato menil, da je na osnovi razpoložljivih dokazov in vitro ter dodatnih dokazov iz kliničnih podatkov, dobljenih z uporabo predlaganega zdravila,
• the CHMP therefore considered it adequately demonstrated that potential differences between the proposed product fitted either with the Device 1 pump or with the Device 2 pump and the reference product do not affect the safety and efficacy of the proposed products, based on the available in vitro evidence and further supported by the clinical data obtained using the proposed product fitted with the Device 1 spray pump, 
opremljenega s črpalko pripomočka 1, zadostno dokazano, da možne razlike med predlaganim zdravilom, opremljenim bodisi s črpalko pripomočka 1 bodisi s črpalko pripomočka 2, ter referenčnim zdravilom ne vplivajo na varnost in učinkovitost predlaganih zdravil; • CHMP je menil, da je razmerje koristi in tveganj predlaganih zdravil pozitivno;
Considering that particle size distribution is an adequate indicator of dissolubility, the CHMP therefore concluded that the dissolution properties of the proposed and the reference products are equivalent, independently of the spray pump device used. 
da so topnostne lastnosti predlaganih zdravil in referenčnega zdravila enakovredne, neodvisno od uporabljenega pripomočka s pršilno črpalko.
300 mg Powder for concentrate for solution for infusion 
300 mg Prašek za koncentrat za raztopino za infundiranje
Intravenous use vial (glass) 
Intravenska uporaba viala (steklo)
MA (EU) number Invented name Strength Pharmaceutical Form Route of Administration 
(Izmišljeno) ime Jakost Farmacevtska oblika Pot uporabe Stična ovojnina
Adopted at the 8-11 July 2019 PRAC 
Sprejeto na seji odbora PRAC med 8. in 11. julijem 2019
Labelling text 
Besedilo za označevanje
Not known (frequency cannot be estimated from the available data) 
Neznana pogostnost: (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
The available epidemiological studies on cardiac malformations show conflicting results. 
Razpoložljive epidemiološke študije o srčnih malformacijah kažejo nasprotujoče si rezultate.
However, as animal studies are not always predictive of human response the use of ondansetron in pregnancy is not recommended. 
Ker pa študije na živalih niso vedno napovedne za človeški odziv, uporaba ondansetrona v nosečnosti ni priporočljiva.
It is not known if <product name> is safe during pregnancy. 
Ni znano, ali je zdravilo <ime zdravila> varno med nosečnostjo.
Evaluation of experimental Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. 
Ovrednotenje eksperimentalnih Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov v zvezi z na sposobnost razmnoževanja.
2 Indicated in neonates and children below 2 years 
2 Indicirana pri novorojenčkih in otrocih, mlajših od 2 let.
In one cohort study including 1.8 million pregnancies, first trimester ondansetron use was associated with an increased risk of oral clefts (3 additional cases per 10 000 women treated; adjusted relative risk, 1.24, (95% CI 1.03-1.48)). 
V kohortni študiji, v kateri so spremljali 1,8 milijona nosečnosti, je bila uporaba ondansetrona v prvem trimesečju povezana s povečanim tveganjem za razcep ustnice in/ali neba (3 dodatni primeri na 10 000 zdravljenih žensk, prilagojeno relativno tveganje, 1,24, (95-odstotni IZ 1,03-1,48)).
If you are already pregnant, think you are might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking <product name>. 
Če ste že noseči, menite, da ste bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete zdravilo <ime zdravila>.
It is recommended to ensure adequate fluid intake during treatment. 
Priporočljivo je, da med zdravljenjem zagotovite ustrezen vnos tekočine.
Women of childbearing potential should consider the use of contraception. 
Ženske v rodni dobi morajo razmisliti o uporabi kontracepcije.
If you are a woman of childbearing potential you may be advised to use effective contraception. 
Če ste ženska v rodni dobi, vam svetujemo uporabo učinkovite kontracepcije.
Mesalazine - Nephrolithiasis (EPITT no 19405) 
Mesalazin - nefrolitiaza (št. EPITT 19405)
Symptoms may include pain in sides of abdomen and blood in urine. 
Simptomi lahko vključujejo bolečine v stranskem predelu trebušne votline in kri v urinu.
If any bleeding requires medical intervention, temporarily interrupt the axitinib dose. 
Če je pri kakršnikoli krvavitvi potreben zdravniški poseg, je treba z odmerjanjem aksitiniba začasno prekiniti.
Axitinib has not been studied in patients who have evidence of untreated brain metastasis or recent active gastrointestinal bleeding, and should not be used in those patients. 
Aksitiniba niso proučevali pri bolnikih, pri katerih obstajajo znaki nezdravljenih možganskih metastaz ali nedavne aktivne krvavitve v prebavilih, zato se pri teh bolnikih ne sme uporabljati.
Special precautions for disposal 
Posebni varnostni ukrepi za odstranjevanje
The safety of ondansetron for use in human pregnancy has not been established. 
Varnost ondansetrona za uporabo pri nosečnicah ni bila dokazana.
Based on human experience from epidemiological studies, ondansetron is suspected to cause orofacial malformations when administered during the first trimester of pregnancy. 
Na podlagi izkušenj pri ljudeh iz epidemioloških študij obstaja sum, da ondansetron povzroča orofacialne malformacije, kadar se jemlje v prvem trimesečju nosečnosti.
• kidney stones and associated kidney pain (see also section 2) 
• ledvični kamni in z njimi povezana bolečina v ledvicah (glejte tudi poglavje 2)
Also, tell your doctor if you have been diagnosed with an aneurysm before taking this medicine. 
Obvestite zdravnika tudi, če so vam diagnosticirali anevrizmo, preden vzamete to zdravilo.
- If you have experienced a previous episode of a tear in the aortic wall known as aortic dissection. 
- Če ste že kdaj doživeli epizodo raztrganja aortne stene, kar imenujemo aortna disekcija.
In clinical studies with axitinib, haemorrhagic events were reported (see section 4.8). 
V kliničnih preskušanjih z aksitinibom so poročali o pojavu krvavitev (glejte poglavje 4.8).
Cases of ruptured aneurysms (including pre-existing aneurysms) have been reported, some with fatal outcome. 
Poročali so o primerih rupture anevrizme (vključno z že obstoječimi anevrizmami), pri nekaterih s smrtnim izidom.
Frequency not known: nephrolithiasis* * See section 4.4 for further information 
Neznana pogostnost: nefrolitiaza* * Za več informacij glejte poglavje 4.4
Tell your doctor if you have an aneurysm (an abnormal balloon-like swelling in the wall of an artery) before taking this medicine. 
Obvestite zdravnika, če imate anevrizmo (nenormalno, balonu podobno oteklino v steni arterije), preden vzamete to zdravilo.
Vascular Endothelial Growth Factor (VEGF) inhibitors for systemic administration3 - Artery dissections and aneurysms (EPITT no 19330) 
Zaviralci žilnega endotelijskega rastnega faktorja (VEGF) za sistemsko dajanje3 -disekcije arterij in anevrizme (EPITT št. 19330)
Ondansetron - Signal of birth defects following in-utero exposure during the first trimester of pregnancy arising from recent publications (EPITT no 19353) 
Ondansetron - znaki prirojenih napak po znotrajmaternični izpostavljenosti v prvem trimesečju nosečnosti, glede na nedavne objave (št. EPITT 19353)
How to store <product name> 
Shranjevanje zdravila <ime zdravila>
You should not use <product name> during the first trimester of pregnancy. 
Zdravila <ime zdravila> ne smete uporabljati v prvem trimesečju nosečnosti.
Cases of nephrolithiasis have been reported with the use of mesalazine including stones with a 100% mesalazine content. 
Pri uporabi mesalazina, vključno s kamni s 100-odstotno vsebnostjo mesalazina, so poročali o primerih nefrolitiaze.
Inlyta may increase your chance of bleeding. 
Zdravilo Inlyta lahko zveča možnosti, da pri vas pride do krvavitev.
This is because <product name> can slightly increase the risk of a baby being born with cleft lip and/or cleft palate (openings or splits in the upper lip and/or the roof of the mouth). 
Zdravilo <ime zdravila> lahko namreč rahlo poveča tveganje za rojstvo dojenčka z razcepljeno ustnico in/ali nebom (odprtinami ali razpokami na zgornji ustnici in/ali v ustnem nebu).
the development of the embryo, or foetus, the course of gestation and periand post-natal development. 
razvojem zarodka ali ploda, potekom gestacije in peri- in postnatalnim razvojem.
The following information is intended for medical or healthcare professionals only. 
Naslednje informacije so namenjene samo zdravstvenemu osebju: Način uporabe:
Inlyta may increase the risk of a rupture. 
Zdravilo Inlyta lahko zveča tveganje za raztrganje.
Other side effects with Inlyta may include: 
Drugi neželeni učinki zdravila Inlyta so lahko:
Cases of aortic aneurysm and/or dissection (including fatal outcome) have been reported. 
Poročali so o primerih aortne anevrizme in/ali disekcije (vključno s primeri s smrtnim izidom).
Uncommon severe pain in the back, chest or abdomen associated with tearing in the wall of the aorta and internal bleeding 
Občasni huda bolečina v hrbtu, prsnem košu ali trebuhu, povezana z raztrganjem stene aorte in notranjo krvavitvijo
What you need to know before you take <product name> 
Kaj morate vedeti, preden boste vzeli zdravilo <ime zdravila>
What you need to know before you take <product name> Warnings and precautions 
Kaj morate vedeti, preden boste vzeli zdravilo <ime zdravila> Opozorila in previdnostni ukrepi
Undesirable effects 
Možni neželeni učinki
Ondansetron should not be used during the first trimester of pregnancy. 
Ondansteron se ne sme uporabljati v prvem trimesečju nosečnosti.
Parenteral nutrition products2 containing amino acids and/or lipids with or without admixture of vitamins and/or trace elements - Adverse outcomes in neonates treated with solutions not protected from light (EPITT no 19423) 
Zdravila za parenteralno prehrano2, ki vsebujejo aminokisline in/ali lipide s primesmi vitaminov in/ali elementov v sledeh ali brez - neželeni učinki pri novorojenčkih, zdravljenih z raztopinami, ki niso zaščitene pred svetlobo (št. EPITT 19423)
Before initiating axitinib therapy in patients with pre-existing aneurysms, this risk should be carefully considered. 
Pred uvedbo zdravljenja z aksitinibom pri bolnikih z že obstoječimi anevrizmami je treba skrbno razmisliti o tem tveganju.
Tell your doctor right away if you have any of these symptoms or a serious bleeding problem during treatment with Inlyta: black tarry stools, coughing up of blood or bloody sputum, or change in your mental status. 
Nemudoma obvestite zdravnika, če se vam med zdravljenjem z zdravilom Inlyta pojavi katerikoli od naslednjih simptomov ali če imate hude težave, povezane s krvavitvami: črno, lepljivo blato, izkašljevanje krvi ali krvav izpljunek ali spremembe v duševnem stanju.
Special precautions for disposal and other handling: 
Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom:
Bleeding. 
Krvavitev.
Talk to your doctor or nurse before taking <product name>: - If you have been diagnosed with an enlargement or "bulge" of the large blood aortic vessel known as aortic aneurysm. 
Pred začetkom jemanja zdravila <ime zdravila> se posvetujte z zdravnikom ali medicinsko sestro: - Če so vam postavili diagnozo razširitve ali "izbokline" velike krvne žile (aorte), kar imenujemo aortna anevrizma.
Summary of product characteristics (* include neonates and if product is indicated in such population) 4.2. 
(* vključiti novorojenčkih in, če je zdravilo indicirano pri tovrstni populaciji) 4.2.
Take care to drink sufficient amount of liquid during treatment with mesalazine. 
Med zdravljenjem z mesalazinom poskrbite za zadosten vnos tekočine.
Package leaflet (* include neonates and if product is indicated in such population) [For products used in <neonates and *> children below 2 years] 2. 
(* vključiti novorojenčkih in, če je zdravilo indicirano pri tovrstni populaciji) [Za zdravila, indicirana pri <novorojenčkih in *> otrocih, mlajših od 2 let] 2.
Kidney stones may develop with use of mesalazine. 
Uporaba mesalazina lahko povzroči nastanek ledvičnih kamnov.
Tell your doctor if you have any bleeding, coughing up of blood or bloody sputum while on treatment with this medicine. 
Obvestite zdravnika, če med zdravljenjem s tem zdravilom pride do kakršnekoli krvavitve, izkašljevanja krvi ali krvavega izpljunka.
Section at the end of the package leaflet: 
Poglavje na koncu navodila za uporabo
Aneurysms and artery dissections 
Anevrizme in arterijske disekcije
An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections). 
Razširitev in oslabitev stene krvne žile ali raztrganina v steni krvne žile (anevrizme in disekcije arterij).
Special warnings and precautions 
4.4 Posebna opozorila in previdnostni ukrepi
Special warnings and precautions for use: [For products indicated in neonates (age up to 28 days)] Light exposure of solutions for intravenous parenteral nutrition, especially after admixture with trace elements and/or vitamins, may have adverse effects on clinical outcome in neonates, due to generation of peroxides and other degradation products. 
Posebna opozorila in previdnostni ukrepi: [Za zdravila, indicirana pri novorojenčkih (starost do 28 dni)] Izpostavljenost raztopin za intravensko parenteralno prehrano svetlobi, zlasti po mešanju z elementi v sledeh in/ali vitamini, ima lahko zaradi nastajanja peroksidov in drugih razgradnih produktov škodljive učinke na klinični izid pri novorojenčkih.
INSTRUCTIONS ON USE (* include neonates and if product is indicated in such population) When used in <neonates and *> children below 2 years, the solution (in bags and administration sets) should be protected from light exposure until administration is completed. 
NAVODILA ZA UPORABO (* vključiti novorojenčkih in, če je zdravilo indicirano pri tovrstni populaciji) Ob uporabi pri <novorojenčkih in *> otrocih, mlajših od 2 let, je treba raztopino (v vrekah in kompletih za dajanje zdravila) do zaključka dajanja zaščititi pred izpostavljenostjo svetlobi.
An enlargement or "bulge" of the aortic vessel or a tear in the aortic wall (aortic aneurysms and dissections). 
Neznana pogostnost razširitev ali "izboklina" aorte ali raztrganje aortne stene (aortne anevrizme in disekcije).
Frequency ‘Not known': Aneurysms and artery dissections Footnotes: hIncluding activated partial thromboplastin time prolonged, anal haemorrhage, aneurysm rupture, arterial haemorrhage... 
Opombe: h vključno s podaljšanim aktiviranim parcialnim tromboplastinskim časom, krvavitvijo iz anusa, rupturo anevrizme, arterijsko krvavitvijo […]
- If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall. 
- Če imate ali ste imeli anevrizmo (razširitev in oslabitev stene krvne žile) ali raztrganino v steni krvne žile.