natgillin/translations-raw huggingface dataset:
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.
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.
These symptoms are usually short lasting and occur at the time the eye drops are used.
Simptomi so običajno kratkotrajni in se pojavijo v času uporabe kapljic za oko.
It is not intended to provide practical advice on how to use Ikervis.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
What is Ikervis and what is it used for?
Kaj je zdravilo Ikervis in za kaj se uporablja?
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.
Zdravilna učinkovina v zdravilu Ikervis, ciklosporin, deluje na celice imunskega sistema (naravnega obrambnega mehanizma telesa), ki sodelujejo pri procesih, ki povzročajo vnetje.
What are the risks associated with Ikervis?
Kakšna tveganja so povezana z zdravilom Ikervis?
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.
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.
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.
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.
Why is Ikervis approved?
Zakaj je bilo zdravilo Ikervis odobreno?
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.
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.
What benefits of Ikervis have been shown in studies?
Kakšne koristi je zdravilo Ikervis izkazalo v študijah?
For more information about treatment with Ikervis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
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.
The medicine is available as single-dose eye drops and the recommended dose is one drop in each affected eye daily at bedtime.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Applying it directly to the eye reduces inflammation and damage there but limits its effects elsewhere in the body.
Nanos zdravila neposredno v oko zmanjša vnetje in poškodbo na tem delu, medtem ko omeji učinke zdravila drugje v telesu.
For practical information about using Ikervis, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Ikervis naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Ikervis contains the active substance ciclosporin.
Zdravilo Ikervis vsebuje zdravilno učinkovino ciklosporin.
Ikervis can only be obtained with a prescription and treatment should only be started by a healthcare professional trained in ophthalmology (eye medicine).
Izdaja zdravila Ikervis je le na recept, zdravljenje z njim pa sme uvesti samo zdravstveni delavec, usposobljen na področju oftalmologije (očesne medicine).
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).
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).
For the full list of all side effects reported with Ikervis, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ikervis, glejte navodilo za uporabo.
How does Ikervis work?
Kako zdravilo Ikervis deluje?
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.
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.
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.
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.
How is Ikervis used?
Kako se zdravilo Ikervis uporablja?
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.
Zdravilo se ne sme uporabljati pri bolnikih, ki imajo ali ki bi lahko imeli okužbo očesa ali tkiv okoli očesa.
Some animals may also have hypersensitivity (allergic) reactions.
Pri nekaterih živalih se lahko pojavijo preobčutljivostne (alergijske) reakcije.
In all studies the vaccinated cattle and sheep were compared with animals that were not immunised (controls).
V vseh študijah so cepljene ovce in govedo primerjali z živalmi, ki niso bile imunizirane (kontrolnimi skupinami).
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.
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).
The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to enhance the immune response.
Cepivo vsebuje tudi „adjuvanse“ (aluminijev hidroksid in saponin) za povečanje imunskega odziva.
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.
Če bo žival v prihodnosti ponovno izpostavljena virusu modrega jezika istega tipa, bo imunski sistem protitelesa izdelal hitreje.
The main measure of effectiveness was the level of the bluetongue virus in the blood (viraemia) of animals.
Glavni merilo učinkovitosti je bila raven virusa modrega jezika v krvi (viremija) živali.
Bovilis BTV8 was initially authorised under ‘exceptional circumstances'.
Zdravilo Bovilis BTV8 je bilo prvotno izdano v „izjemnih okoliščinah“.
When it is given to cattle and sheep, the animals' immune system recognises the virus as ‘foreign' and produce antibodies against it.
Ko govedo ali ovco cepimo, imunski sistem živali prepozna virus kot „tujek“ in proti njemu izdela protitelesa.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) naučijo, kako naj se brani pred boleznijo.
One injection is enough to vaccinate sheep, but cattle will need a second injection approximately three weeks later.
Za cepljenje ovac zadostuje ena injekcija, govedo pa potrebuje drugo injekcijo tri do štiri tedne kasneje.
This means that it was not possible at the time of the initial authorisation to obtain complete information about Bovilis BTV8.
To pomeni, da ob prvotni izdaji ni bilo mogoče pridobiti vseh podatkov o cepivu Bovilis BTV8.
The vaccine is used to prevent viraemia (the presence of viruses in the blood) in sheep and to limit viraemia in cattle.
Cepivo se uporablja za preprečitev viremije (prisotnosti virusa v krvi) pri ovcah in omejitev viremije pri govedu.
The risk of bluetongue transmission to cattle following vaccination with Bovilis BTV8 was further investigated in two epidemiological models.
Tveganje prenosa okužbe z virusom modrega jezika pri govedu po opravljenem cepljenju s cepivom Bovilis BTV8 so nadalje raziskali v dveh epidemioloških modelih.
Inactivated adjuvanted vaccine against bluetongue virus serotype 8
inaktivirano adjuvantno cepivo proti virusu bolezni modrikastega jezika, serotip 8
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..
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.
The withdrawal period for both sheep and cattle for meat and milk is zero days.
Karenca za meso in mleko pri ovcah in govedu je nič dni.
The CVMP concluded that the benefits of Bovilis BTV8 exceed the risks and recommended that Bovilis BTV8 be given a marketing authorisation.
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.
The European Commission granted a marketing authorisation valid throughout the European Union, for Bovilis BTV8 on 06/09/2010.
Evropska komisija je dovoljenje za promet z zdravilom Bovilis BTV8, veljavno po vsej Evropski uniji, odobrila 6. septembra 2010.
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.
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.
Bovilis BTV8 is a vaccine.
Zdravilo Bovilis BTV8 je cepivo.
The first injection is given from one month of age in sheep and from six weeks of age in cattle.
Prva injekcija se da vsaj en mesec starim ovcam in vsaj šest tednov staremu govedu.
There can also be a temporary swelling at the injection site, lasting for up to three weeks in sheep and six weeks in cattle.
Na mestu injiciranja se lahko pojavi prehodna oteklina, ki izgine v največ treh tednih pri ovcah in največ šest tednih pri govedu.
Bovilis BTV8 contains bluetongue virus that has been inactivated so that it cannot cause the disease.
Zdravilo Bovilis BTV8 vsebuje viruse modrega jezika, ki so inaktivirani in zato ne morejo povzročiti bolezni.
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.
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.
Bovilis BTV8 was shown to be safe for use in pregnant ewes and cattle.
Dokazano je bilo, da se lahko cepivo Bovilis BTV8 varno uporablja pri brejih ovcah in govedu.
Other information about Bovilis BTV8:
Druge informacije o zdravilu Bovilis BTV8:
What benefit has Bovilis BTV8 shown during the studies?
Kakšne koristi je zdravilo Bovilis BTV8 izkazalo med študijami?
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.
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.
Bovilis BTV8 is a vaccine that contains an inactivated (killed) bluetongue serotype 8 virus as the active substance.
Bovilis BTV8 je cepivo, ki kot zdravilno učinkovino vsebuje inaktiviran (uničen) virus bolezni modrikastega jezika, serotip 8.
What is the risk associated with Bovilis BTV8?
Kakšna tveganja so povezana z zdravilom Bovilis BTV8?
The virus exists in several forms (serotypes) throughout the world; the type used in Bovilis BTV8 is serotype 8.
Virus obstaja v različnih oblikah (serotipih) po vsem svetu.
Why has Bovilis BTV8 been approved?
Zakaj je bilo zdravilo Bovilis BTV8 odobreno?
How has Bovilis BTV8 been studied?
Kako je bilo zdravilo Bovilis BTV8 raziskano?
What is Bovilis BTV8 used for?
Za kaj se zdravilo Bovilis BTV8 uporablja?
What is Bovilis BTV8?
Kaj je zdravilo Bovilis BTV8?
How does Bovilis BTV8 work?
Kako zdravilo Bovilis BTV8 deluje?
This summary was last updated in 02-2018.
Povzetek je bil nazadnje posodobljen 02-2018.
It is given by injection under the skin, once a day.
Injicira se pod kožo enkrat dnevno.
The diagnosis must be confirmed by genetic testing.
Diagnoza mora biti potrjena z genetskim testiranjem.
• do not grow normally because they do not have enough growth hormone;
• ne rastejo normalno, ker nimajo dovolj rastnega hormona;
These side effects are uncommon in children (may affect between 1 and 10 patients in 1,000).
Ti neželeni učinki so pri otrocih občasni (lahko se pojavijo pri 1 do 10 bolnikov od 1 000).
It must also not be used for promoting growth in children with closed epiphyses (when the large bones have finished growing).
Prav tako se ne sme uporabljati za pospeševanje rasti otrok z zaprtimi epifizami (ko so velike kosti prenehale rasti).
The European Commission granted a marketing authorisation valid throughout the European Union for Omnitrope on 12 April 2006.
Evropska komisija je dovoljenje za promet z zdravilom Omnitrope, veljavno po vsej Evropski uniji, izdala 12. aprila 2006.
The deficiency can have started in adulthood or childhood, and needs to be confirmed by testing before treatment.
Pomanjkanje se lahko začne v odrasli dobi ali v otroštvu in ga je pred zdravljenjem treba potrditi s testiranjem.
• have a genetic condition called Prader-Willi syndrome.
• imajo genetsko bolezen, imenovano Prader-Willijev sindrom.
Children receiving Omnitrope and Genotropin grew at a similar rate of about 10.7 cm per year.
Otroci, ki so prejemali zdravilo Omnitrope ali Genotropin, so zrasli podobno hitro za približno 10,7 cm na leto.
The full EPAR for Omnitrope can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
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.
The dose may need to be adjusted over time, depending on change in body weight and response to treatment.
Morda bo treba sčasoma prilagoditi odmerek, odvisno od spremembe telesne mase in odziva na zdravljenje.
• are short because they have long-term kidney disease or a genetic disorder called Turner syndrome;
• so premajhne rasti, ker imajo dolgotrajno bolezen ledvic ali genetsko motnjo, imenovano Turnerjev sindrom;
Omnitrope is given to improve their growth and body composition (by reducing fat and improving muscle mass).
Zdravilo Omnitrope se daje za izboljšanje rasti in sestave telesa (z zmanjšanjem maščobe in izboljšanjem mišične mase).
In adults, side effects related to fluid retention, such as peripheral oedema (swelling, especially of the ankles and feet), paraesthesia (numbness or tingling), joint and muscle pain, and stiffness of the limbs are common (may affect between 1 and 10 patients in 100).
Pri odraslih so neželeni učinki, ki so povezani z zastajanjem tekočine v telesu in se kažejo kot periferni edem (otekanje, zlasti gležnjev in nog), parestezija (odrevenelost ali mravljinčenje), bolečine v sklepih in mišicah ter okorelost okončin, pogosti (lahko se pojavijo pri 1 do 10 bolnikov od 100).
This means that Omnitrope is highly similar to a biological medicine (the ‘reference medicine') that is already authorised in the EU.
To pomeni, da je zelo podobno biološkemu zdravilu (t. i. „referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU).
This is a summary of the European public assessment report (EPAR) for Omnitrope.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Omnitrope.
As with all protein medicines, some patients may develop antibodies (proteins that are produced in response to Omnitrope).
Kot pri vseh zdravilih, ki vsebujejo beljakovine, se lahko pri nekaterih bolnikih pojavijo protitelesa (beljakovine, ki se tvorijo kot odziv na zdravilo Omnitrope).
It is important for growth during childhood and adolescence, and it also affects how the body handles proteins, fat and carbohydrates.
Pomemben je za rast v otroštvu in adolescenci, vpliva pa tudi na presnovo beljakovin, maščob in ogljikovih hidratov v telesu.
What measures are being taken to ensure the safe use of Omnitrope?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Omnitrope?
Omnitrope is a medicine used to treat children who:
Zdravilo Omnitrope se uporablja za zdravljenje otrok, ki:
What is Omnitrope and what is it used for?
Kaj je zdravilo Omnitrope in za kaj se uporablja?
The European Medicines Agency considered that, in accordance with EU requirements for biosimilar medicines, Omnitrope has been shown to have a comparable quality, safety and effectiveness to Genotropin.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Omnitrope po kakovosti, varnosti in učinkovitosti primerljivo zdravilu Genotropin.
• are short and were born small for their gestational age, and have not caught up by the age of
• so premajhne rasti in so se rodili majhni za svojo gestacijsko starost ter do starosti 4 let ali več niso nadomestili zaostanka;
Somatropin is produced by a method known as ‘recombinant DNA technology': the hormone is made by bacteria into which a gene (DNA) has been introduced that makes them able to produce somatropin.
Proizvaja se z metodo, imenovano „tehnologija rekombinantne DNK“, pri kateri hormon tvorijo bakterije, ki so prejele gen (DNK), kar jim omogoča tvorjenje somatropina.
Results showed that, after treatment for 9 months, Omnitrope was as effective as Genotropin in improving growth.
Rezultati so pokazali, da je bilo po 9-mesečnem zdravljenju zdravilo Omnitrope enako učinkovito kot zdravilo Genotropin pri izboljšanju rasti.
Other information about Omnitrope
Druge informacije o zdravilu Omnitrope
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Omnitrope have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Omnitrope upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Omnitrope was compared with Genotropin in 89 children with a lack of growth hormone who had not been treated before.
Zdravilo Omnitrope so primerjali z zdravilom Genotropin pri 89 otrocih s pomanjkanjem rastnega hormona, ki predhodno še niso bili zdravljeni.
For more information about treatment with Omnitrope, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Omnitrope preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What benefits of Omnitrope have been shown in studies?
Kakšne koristi je zdravilo Omnitrope izkazalo v študijah?
The patient or caregiver can inject Omnitrope, after being trained by a doctor or a nurse.
Bolnik ali negovalec lahko zdravilo Omnitrope injicirata sama, potem ko sta ju za to usposobila zdravnik ali medicinska sestra.
What are the risks associated with Omnitrope?
Kakšna tveganja so povezana z zdravilom Omnitrope?
Omnitrope must not be used if the patient has an active tumour or an acute life-threatening illness.
Zdravilo Omnitrope se ne sme uporabljati pri bolnikih, ki imajo aktiven tumor ali akutno smrtno nevarno bolezen.
The doctor calculates the dose for each patient individually according to the body weight and the condition being treated.
Zdravnik izračuna odmerek za vsakega bolnika posebej glede na njegovo telesno maso in bolezen, zaradi katere se zdravi.
The active substance in Omnitrope, somatropin, is identical to the human growth hormone, which it replaces.
Zdravilna učinkovina v zdravilu Omnitrope, somatropin, je enaka človeškemu rastnemu hormonu, ki ga nadomešča.
Omnitrope is also used as replacement therapy in adult patients with pronounced growth hormone deficiency.
Zdravilo Omnitrope se uporablja tudi kot nadomestno zdravljenje pri odraslih bolnikih z izrazitim pomanjkanjem rastnega hormona.
For practical information about using Omnitrope, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Omnitrope naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
It is not intended to provide practical advice on how to use Omnitrope.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The medicine is available as a powder and solvent, which are made up into a solution for injection, or as a ready-to-use solution in a cartridge.
Zdravilo je na voljo v obliki praška in vehikla za pripravo raztopine za injiciranje ali v obliki pripravljene raztopine v vložku.
Why is Omnitrope approved?
Zakaj je bilo zdravilo Omnitrope odobreno?