FrancophonIA/ELRC3.0 huggingface dataset:
English: The use of Omidria during intraocular lens replacement surgery may cause vision to be temporarily affected.
Slovenian: Uporaba zdravila Omidria med kirurško vstavitvijo umetne intraokularne leče lahko začasno poslabša vid (glejte poglavje 4.7).
English: - Especially, tell your doctor if you are taking atropine, a medicine used to dilate (widen) the pupil of the eye.Taking atropine at the same time as Omidria may increase blood pressure and cause the heart to beat faster in some patients.
Slovenian: - Predvsem morate zdravnika obvestiti, če jemljete atropin, zdravilo, ki se uporablja za širjenje očesne zenice.
English: Significant elevations in blood pressure have been reported following instillation of topical ocular phenylephrine.
Slovenian: Po vkapavanju lokalnega fenilefrina za oko so poročali o pomembnem zvišanju krvnega tlaka.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular irrigation phenylephrine/ketorolac
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Omidria 10 mg/ml + 3 mg/ml koncentrat za raztopino za intraokularno izpiranje fenilefrin/ketorolak
English: One 4 mL vial contains phenylephrine hydrochloride equal to 40.6 mg phenylephrine and ketorolac trometamol equal to 11.5 mg ketorolac.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena 4-mililitrska viala vsebuje fenilefrinijev klorid, ki ustreza 40,6 mg fenilefrina, in trometamolijev ketorolakat, ki ustreza 11,5 mg ketorolaka.
English: Package leaflet: Information for the user Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular irrigation phenylephrine/ketorolac
Slovenian: Navodilo za uporabo Omidria 10 mg/ml + 3 mg/ml koncentrat za raztopino za intraokularno izpiranje fenilefrin/ketorolak
English: NAME OF THE MEDICINAL PRODUCT Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular irrigation phenylephrine/ketorolac
Slovenian: Omidria 10 mg/ml + 3 mg/ml koncentrat za raztopino za intraokularno izpiranje fenilefrin/ketorolak
English: Pupil diameter was measured throughout the surgical procedure.
Slovenian: Med kirurškim posegom so merili premer zenice.
English: Omidria is not recommended during pregnancy.
Slovenian: Uporaba med nosečnostjo ni priporočljiva.
English: Following dilution do not store above 25 ˚C
Slovenian: Po redčenju shranjujte pri temperaturi do 25 ˚C.
English: Omidria is used as a solution to rinse the eye (irrigation solution) during surgery to replace the lens.
Slovenian: Zdravilo Omidria se uporablja v obliki raztopine za izpiranje očesa med kirurško vstavitvijo umetne intraokularne leče.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ikervis on 19 March 2015.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Ikervis, veljavno po vsej Evropski uniji, izdala 19. marca 2015.
English: The doctor should confirm the need for continuing treatment at least every 6 months.
Slovenian: Zdravnik mora najmanj vsakih šest mesecev potrditi, da obstaja potreba po nadaljevanju zdravljenja.
English: What measures are being taken to ensure the safe and effective use of Ikervis?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ikervis?
English: It is used when treatment with artificial tears (tear substitutes) is insufficient to improve the condition.
Slovenian: Zdravilo se uporablja, kadar zdravljenje z umetnimi solzami (nadomestki solz) ne zadostuje za izboljšanje stanja.
English: About 29% (44 of 154) of those given Ikervis responded, compared with 23% (21 of 91) given the vehicle.
Slovenian: Odzvalo se je približno 29 % (44 od 154) bolnikov, ki so prejemali zdravilo Ikervis, v primerjavi s 23 % (21 od 91) bolnikov, ki so prejemali vehikel.
English: The full EPAR and risk management plan summary for Ikervis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Ikervis sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: If other eye drops are used, the different medicines must be given at least 15 minutes apart.
Slovenian: Če se uporabljajo tudi druge kapljice za oko, je treba zdravili dati v razmiku najmanj 15 minut.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ikervis's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Ikervis večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Other information about Ikervis
Slovenian: Druge informacije o zdravilu Ikervis
English: Ikervis should be given last.
Slovenian: Zdravilo Ikervis je treba dati nazadnje.
English: This is a summary of the European public assessment report (EPAR) for Ikervis.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ikervis.
English: A risk management plan has been developed to ensure that Ikervis is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Ikervis je bil pripravljen načrt obvladovanja tveganj.
English: The CHMP considered that this was clinically meaningful, since none of the available medicines for the condition have been shown to reduce damage to the surface of the eye, which might help prevent the progression of the disease.
Slovenian: Odbor CHMP je menil, da je to zmanjšanje klinično pomembno, saj za nobeno razpoložljivo zdravilo za to bolezen ni bilo dokazano, da bi zmanjšalo poškodbo površine očesa, kar lahko pomaga preprečiti napredovanje bolezni.
English: Ikervis ciclosporin
Slovenian: Ikervis ciklosporin
English: These symptoms are usually short lasting and occur at the time the eye drops are used.
Slovenian: Simptomi so običajno kratkotrajni in se pojavijo v času uporabe kapljic za oko.
English: It is not intended to provide practical advice on how to use Ikervis.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: What is Ikervis and what is it used for?
Slovenian: Kaj je zdravilo Ikervis in za kaj se uporablja?
English: The active substance in Ikervis, ciclosporin, acts on cells of the immune system (the body's natural defences) that are involved in the processes that cause inflammation.
Slovenian: Zdravilna učinkovina v zdravilu Ikervis, ciklosporin, deluje na celice imunskega sistema (naravnega obrambnega mehanizma telesa), ki sodelujejo pri procesih, ki povzročajo vnetje.
English: What are the risks associated with Ikervis?
Slovenian: Kakšna tveganja so povezana z zdravilom Ikervis?
English: Regarding safety, the medicine was well tolerated, with mainly short-lasting effects on the eye at the time the eye drops are used; the risk of effects on the body as a whole was considered to be low.
Slovenian: Z vidika varnosti so bolniki zdravilo dobro prenašali, saj so v glavnem opažali samo kratkotrajne neželene učinke na oko v času uporabe kapljic, tveganje za učinke na celotno telo pa je bilo ocenjeno kot majhno.
English: Although Ikervis had not been shown to be any better than the vehicle in improving symptoms such as discomfort and pain, there was evidence that it could reduce the inflammation and damage to the cornea associated with keratitis.
Slovenian: Čeprav se zdravilo Ikervis ni izkazalo za učinkovitejše od vehikla pri izboljšanju simptomov, kot sta neugodje in bolečina, je bilo dokazano, da lahko zmanjša vnetje in poškodbo roženice, povezana s keratitisom.
English: Why is Ikervis approved?
Slovenian: Zakaj je bilo zdravilo Ikervis odobreno?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ikervis, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: What benefits of Ikervis have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Ikervis izkazalo v študijah?
English: For more information about treatment with Ikervis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Ikervis preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The medicine is available as single-dose eye drops and the recommended dose is one drop in each affected eye daily at bedtime.
Slovenian: Zdravilo je na voljo v obliki enoodmernih kapljic za oko, priporočeni odmerek pa je ena kapljica v vsako prizadeto oko enkrat na dan pred spanjem.
English: The most common side effects with Ikervis (which may affect more than 1 in 10 people) are pain and irritation in the eye; other common side effects are lacrimation (excessive tears), ocular hyperaemia (red eye), and erythema (redness) of the eyelid.
Slovenian: Najpogostejša neželena učinka zdravila Ikervis (ki lahko prizadeneta več kot 1 osebo od 10) sta bolečina v očesu in draženje očesa, drugi pogosti neželeni učinki pa so solzenje (čezmerna količina solz), očesna hiperemija (rdeče oko) in eritem (rdečina) veke.
English: Without sufficient protection from the tear fluid, the cornea can get damaged and become inflamed (keratitis), which can eventually lead to ulceration, infection and reduced vision.
Slovenian: Če solzna tekočina ne nudi zadostne zaščite, se roženica lahko poškoduje in se vname (keratitis), kar lahko sčasoma privede do nastanka razjede, okužbe in poslabšanega vida.
English: In patients with dry eye disease, either not enough tear fluid is produced to create the protective film of moisture that normally coats the surface of the eye, or abnormalities in the tear fluid cause it to dry out too quickly.
Slovenian: Pri bolnikih s sindromom suhega očesa bodisi ne nastaja dovolj solzne tekočine, da bi se ustvaril zaščitni sloj vlage, ki običajno prekriva površino očesa, bodisi se zaradi nepravilnosti v solzni tekočini ta prehitro posuši.
English: The main measure of effectiveness was the proportion of patients whose condition responded to treatment after six months, as measured by a combination of damage to the cornea and a score for the level of symptoms, including discomfort and pain.
Slovenian: Glavno merilo učinkovitosti je bil delež bolnikov, katerih bolezen se je po šestih mesecih odzvala na zdravljenje, kar so ocenili na podlagi poškodbe roženice in rezultatov ocene stopnje izraženosti simptomov, ki so vključevali neugodje in bolečino.
English: Applying it directly to the eye reduces inflammation and damage there but limits its effects elsewhere in the body.
Slovenian: Nanos zdravila neposredno v oko zmanjša vnetje in poškodbo na tem delu, medtem ko omeji učinke zdravila drugje v telesu.
English: For practical information about using Ikervis, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Ikervis naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Ikervis contains the active substance ciclosporin.
Slovenian: Zdravilo Ikervis vsebuje zdravilno učinkovino ciklosporin.
English: Ikervis can only be obtained with a prescription and treatment should only be started by a healthcare professional trained in ophthalmology (eye medicine).
Slovenian: Izdaja zdravila Ikervis je le na recept, zdravljenje z njim pa sme uvesti samo zdravstveni delavec, usposobljen na področju oftalmologije (očesne medicine).
English: The benefits of Ikervis have been shown in one main study involving 246 patients with severe dry eye disease, where Ikervis was compared with the vehicle (the same eye drop formula but without any active substance).
Slovenian: Koristi zdravila Ikervis so dokazali v eni glavni študiji z 246 bolniki s hudim sindromom suhega očesa, v kateri so zdravilo Ikervis primerjali z vehiklom (enakim pripravkom v obliki kapljic za oko, ki pa ni vseboval nobene zdravilne učinkovine).
English: For the full list of all side effects reported with Ikervis, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ikervis, glejte navodilo za uporabo.
English: How does Ikervis work?
Slovenian: Kako zdravilo Ikervis deluje?
English: Ikervis is a medicine used to treat severe keratitis, an inflammation of the cornea (the transparent layer covering the front of the eye) in adult patients with dry eye disease.
Slovenian: Ikervis je zdravilo, ki se uporablja za zdravljenje hudega keratitisa, tj. vnetja roženice (prozorne plasti, ki prekriva sprednji del očesa), pri odraslih bolnikih s sindromom suhega očesa.
English: The proportion of patients who responded to treatment was therefore similar in the two groups, but when only the damage to the cornea was considered, Ikervis was significantly better than the vehicle at reducing it. Levels of HLADR (a measure of inflammation in eye cells) were also reduced in patients using Ikervis compared with the dummy treatment.
Slovenian: Delež bolnikov, ki so se odzvali na zdravljenje, je bil torej v obeh skupinah podoben, ko so primerjali samo poškodbo roženice, pa je bilo zdravilo Ikervis pri zmanjšanju poškodbe znatno učinkovitejše od vehikla.
English: How is Ikervis used?
Slovenian: Kako se zdravilo Ikervis uporablja?
English: The medicine must not be used in patients who have or are suspected to have an infection of the eye or the tissues around the eye. For the full list of restrictions, see the package leaflet.
Slovenian: Zdravilo se ne sme uporabljati pri bolnikih, ki imajo ali ki bi lahko imeli okužbo očesa ali tkiv okoli očesa.
English: Some animals may also have hypersensitivity (allergic) reactions.
Slovenian: Pri nekaterih živalih se lahko pojavijo preobčutljivostne (alergijske) reakcije.
English: In all studies the vaccinated cattle and sheep were compared with animals that were not immunised (controls).
Slovenian: V vseh študijah so cepljene ovce in govedo primerjali z živalmi, ki niso bile imunizirane (kontrolnimi skupinami).
English: After vaccination, animals may have a slightly raised temperature (usually not more than 0.5°C, but in individual cases up to about 2°C) for up to three days after vaccination.
Slovenian: Do treh dni po cepljenju je možno rahlo povišanje telesne temperature (navadno ne za več kot 0,5 °C, v posameznih primerih do približno 2 °C).
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to enhance the immune response.
Slovenian: Cepivo vsebuje tudi „adjuvanse“ (aluminijev hidroksid in saponin) za povečanje imunskega odziva.
English: In the future, if the animals are exposed to the same type of bluetongue virus, the immune system will be able to produce antibodies more quickly.
Slovenian: Če bo žival v prihodnosti ponovno izpostavljena virusu modrega jezika istega tipa, bo imunski sistem protitelesa izdelal hitreje.
English: The main measure of effectiveness was the level of the bluetongue virus in the blood (viraemia) of animals.
Slovenian: Glavni merilo učinkovitosti je bila raven virusa modrega jezika v krvi (viremija) živali.
English: Bovilis BTV8 was initially authorised under ‘exceptional circumstances'.
Slovenian: Zdravilo Bovilis BTV8 je bilo prvotno izdano v „izjemnih okoliščinah“.
English: When it is given to cattle and sheep, the animals' immune system recognises the virus as ‘foreign' and produce antibodies against it.
Slovenian: Ko govedo ali ovco cepimo, imunski sistem živali prepozna virus kot „tujek“ in proti njemu izdela protitelesa.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Slovenian: Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) naučijo, kako naj se brani pred boleznijo.
English: One injection is enough to vaccinate sheep, but cattle will need a second injection approximately three weeks later.
Slovenian: Za cepljenje ovac zadostuje ena injekcija, govedo pa potrebuje drugo injekcijo tri do štiri tedne kasneje.
English: This means that it was not possible at the time of the initial authorisation to obtain complete information about Bovilis BTV8.
Slovenian: To pomeni, da ob prvotni izdaji ni bilo mogoče pridobiti vseh podatkov o cepivu Bovilis BTV8.
English: The vaccine is used to prevent viraemia (the presence of viruses in the blood) in sheep and to limit viraemia in cattle.
Slovenian: Cepivo se uporablja za preprečitev viremije (prisotnosti virusa v krvi) pri ovcah in omejitev viremije pri govedu.
English: The risk of bluetongue transmission to cattle following vaccination with Bovilis BTV8 was further investigated in two epidemiological models.
Slovenian: Tveganje prenosa okužbe z virusom modrega jezika pri govedu po opravljenem cepljenju s cepivom Bovilis BTV8 so nadalje raziskali v dveh epidemioloških modelih.
English: Inactivated adjuvanted vaccine against bluetongue virus serotype 8
Slovenian: inaktivirano adjuvantno cepivo proti virusu bolezni modrikastega jezika, serotip 8
English: The efficacy of the vaccine in cattle and sheep was studied in a number of laboratory trials; in cattle from six weeks of age and in sheep from one month of age..
Slovenian: Učinkovitost cepiva pri govedu in ovcah so proučili v številnih laboratorijskih preskušanjih, in sicer so cepivo uporabili pri govedu, starejšemu od šest tednov, in ovcah, starejših od enega meseca.
English: The withdrawal period for both sheep and cattle for meat and milk is zero days.
Slovenian: Karenca za meso in mleko pri ovcah in govedu je nič dni.
English: The CVMP concluded that the benefits of Bovilis BTV8 exceed the risks and recommended that Bovilis BTV8 be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Bovilis BTV8 večje od z njim povezanih tveganj, in priporočil, da se za zdravilo Bovilis BTV8 izda dovoljenje za promet.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Bovilis BTV8 on 06/09/2010.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Bovilis BTV8, veljavno po vsej Evropski uniji, odobrila 6. septembra 2010.
English: The safety of the vaccine was studied in laboratory safety studies carried out with an overdose of Bovilis BTV8 in young lambs and calves and in pregnant ewes and cows.
Slovenian: Varnost cepiva so proučili v laboratorijskih študijah varnosti, ki so jih opravili z uporabo čezmernih odmerkov cepiva Bovilis BTV8 pri jagnjetih in teletih ter brejih ovcah in kravah.
English: Bovilis BTV8 is a vaccine.
Slovenian: Zdravilo Bovilis BTV8 je cepivo.
English: The first injection is given from one month of age in sheep and from six weeks of age in cattle.
Slovenian: Prva injekcija se da vsaj en mesec starim ovcam in vsaj šest tednov staremu govedu.
English: There can also be a temporary swelling at the injection site, lasting for up to three weeks in sheep and six weeks in cattle.
Slovenian: Na mestu injiciranja se lahko pojavi prehodna oteklina, ki izgine v največ treh tednih pri ovcah in največ šest tednih pri govedu.
English: Bovilis BTV8 contains bluetongue virus that has been inactivated so that it cannot cause the disease.
Slovenian: Zdravilo Bovilis BTV8 vsebuje viruse modrega jezika, ki so inaktivirani in zato ne morejo povzročiti bolezni.
English: The studies showed that the vaccine is safe for both sheep and cattle and that it prevents viraemia in sheep from one month of age when infected with bluetongue virus serotype 8, whereas Bovilis BTV8 reduces viraemia in cattle from six weeks of age.
Slovenian: Študije so pokazale, da je cepivo Bovilis BTV 8 varno za ovce in govedo ter da preprečuje viremijo pri ovcah, ki so stare vsaj en mesec in so okužene z virusom modrega jezika, serotip 8, zmanjša pa tudi viremijo pri govedu, starejšemu od šest tednov.
English: Bovilis BTV8 was shown to be safe for use in pregnant ewes and cattle.
Slovenian: Dokazano je bilo, da se lahko cepivo Bovilis BTV8 varno uporablja pri brejih ovcah in govedu.
English: Other information about Bovilis BTV8:
Slovenian: Druge informacije o zdravilu Bovilis BTV8:
English: What benefit has Bovilis BTV8 shown during the studies?
Slovenian: Kakšne koristi je zdravilo Bovilis BTV8 izkazalo med študijami?
English: Bovilis BTV8 is used in cattle and sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Slovenian: Zdravilo Bovilis BTV8 se uporablja pri govedu in ovcah za zaščito pred boleznijo modrega jezika, tj. okužbo, ki jo povzroča virus modrega jezika, ki ga prenašajo krvosesi insekti.
English: Bovilis BTV8 is a vaccine that contains an inactivated (killed) bluetongue serotype 8 virus as the active substance.
Slovenian: Bovilis BTV8 je cepivo, ki kot zdravilno učinkovino vsebuje inaktiviran (uničen) virus bolezni modrikastega jezika, serotip 8.
English: What is the risk associated with Bovilis BTV8?
Slovenian: Kakšna tveganja so povezana z zdravilom Bovilis BTV8?
English: The virus exists in several forms (serotypes) throughout the world; the type used in Bovilis BTV8 is serotype 8.
Slovenian: Virus obstaja v različnih oblikah (serotipih) po vsem svetu.
English: Why has Bovilis BTV8 been approved?
Slovenian: Zakaj je bilo zdravilo Bovilis BTV8 odobreno?
English: How has Bovilis BTV8 been studied?
Slovenian: Kako je bilo zdravilo Bovilis BTV8 raziskano?
English: What is Bovilis BTV8 used for?
Slovenian: Za kaj se zdravilo Bovilis BTV8 uporablja?
English: What is Bovilis BTV8?
Slovenian: Kaj je zdravilo Bovilis BTV8?
English: How does Bovilis BTV8 work?
Slovenian: Kako zdravilo Bovilis BTV8 deluje?
English: This summary was last updated in 02-2018.
Slovenian: Povzetek je bil nazadnje posodobljen 02-2018.
English: It is given by injection under the skin, once a day.
Slovenian: Injicira se pod kožo enkrat dnevno.
English: The diagnosis must be confirmed by genetic testing.
Slovenian: Diagnoza mora biti potrjena z genetskim testiranjem.
English: • do not grow normally because they do not have enough growth hormone;
Slovenian: • ne rastejo normalno, ker nimajo dovolj rastnega hormona;
English: These side effects are uncommon in children (may affect between 1 and 10 patients in 1,000).
Slovenian: Ti neželeni učinki so pri otrocih občasni (lahko se pojavijo pri 1 do 10 bolnikov od 1 000).
English: It must also not be used for promoting growth in children with closed epiphyses (when the large bones have finished growing).
Slovenian: Prav tako se ne sme uporabljati za pospeševanje rasti otrok z zaprtimi epifizami (ko so velike kosti prenehale rasti).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Omnitrope on 12 April 2006.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Omnitrope, veljavno po vsej Evropski uniji, izdala 12. aprila 2006.
English: The deficiency can have started in adulthood or childhood, and needs to be confirmed by testing before treatment.
Slovenian: Pomanjkanje se lahko začne v odrasli dobi ali v otroštvu in ga je pred zdravljenjem treba potrditi s testiranjem.
English: • have a genetic condition called Prader-Willi syndrome.
Slovenian: • imajo genetsko bolezen, imenovano Prader-Willijev sindrom.
English: Children receiving Omnitrope and Genotropin grew at a similar rate of about 10.7 cm per year.
Slovenian: Otroci, ki so prejemali zdravilo Omnitrope ali Genotropin, so zrasli podobno hitro za približno 10,7 cm na leto.
English: The full EPAR for Omnitrope can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Omnitrope je na voljo na spletni strani agencije: website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.