natgillin/translations-raw huggingface dataset:
You should self assess for increased acne (a common side effect), increased hair growth on your face, loss of hair, deepening of your voice or enlargement of your clitoris, which all could be signs of side effects of testosterone, which is the active substance in Intrinsa. 
Opazujte te znake povečanja pojava aken (pogosti neželeni učinek), povečane rasti dlak na obrazu, izpadanja las, znižanja glasu ali povečanja klitorisa, ker so lahko znaki neželenih učinkov testosterona, ki je zdravilna učinkovina v zdravilu Intrinsa.
There were no significant differences in serum estradiol and estrone levels in patients treated with Intrinsa for up to 52 weeks compared to baseline. 
ki so prejemale zdravljenje z zdravilom Intrinsa, po 52 tednih ni bilo pomembnih razlik v koncentracijah estradiola in estrona, v primerjavi z izhodiščno vrednostjo.
Marketing Authorisation Holder Warner Chilcott UK Limited Old Belfast Road Millbrook, Larne 
Imetnik dovoljenja za promet z zdravilom Warner Chilcott UK Limited Old Belfast Road
DHT concentrations increased in parallel with testosterone concentrations during Intrinsa treatment. 
Med zdravljenjem z zdravilom Intrinsa se koncentracije DHT povečajo skupaj s koncentracijami testosterona.
Agitation, anxiety 
- vznemirjenost - anksioznost - motnje pozornosti
Intrinsa is intended for use by women up to the age of 60 years who: - have a low sexual desire which is causing distress or concern, and - have had both of their ovaries removed, and - have had their womb removed (hysterectomy), and - are receiving estrogen therapy. 
imajo nizko spolno željo, ki povzroča stisko ali skrbi in so jim odstranili oba jajčnika in so jim odstranili maternico (histerektomija) in prejemajo zdravljenje z estrogenom.
Efficacy versus placebo was significant across a range of subgroups which included patients separated by the following baseline characteristics: age (all subgroups up to age 65 years); body weight (up to 80 kg) and oophorectomy (up to 15 years ago). 
ki so jih ločili glede na naslednje značilnosti: starost (vse podskupine do starosti 65 let), telesna masa
HOW TO STORE INTRINSA 
SHRANJEVANJE ZDRAVILA INTRINSA
Hepatic impairment No studies have been conducted in patients with hepatic impairment. 
Okvarjeno delovanje jeter Študij pri bolnikih z okvarjenim delovanjem jeter niso izvajali.
Oedema may be a serious complication from high doses of testosterone, however, this is not expected from low dose of testosterone delivered by the Intrinsa patch. 
Edem je lahko resen zaplet zaradi visokih odmerkov testosterona, vendar pa se ne pričakuje, da bi nastal zaradi nizkih ravni testosterona, ki jih vnesete z obližem zdravila Intrinsa, če imate raka sluznice maternice (rak endometrija), morate vedeti, da je na voljo le malo informacij o učinkih testosterona na sluznico maternice (endometrij).
What Intrinsa contains 
DODATNE INFORMACIJE Kaj vsebuje zdravilo Intrinsa
Intrinsa 300 micrograms/24 hours transdermal patch Testosterone 
Intrinsa 300 mikrogramov/24 ur transdermalni obliž Testosteron
A responder analysis of the pivotal phase II and III studies showed significant improvements in all three major clinical endpoints versus placebo in patients on concomitant transdermal and oral non-CEE estrogens. 
ki so sočasno prejemale transdermalne in druge peroralne estrogene kot CEE, pokazala pomembno izboljšanje v primerjavi s placebom pri vseh treh kliničnih končnih točkah.
NAME OF THE MEDICINAL PRODUCT Intrinsa 300 micrograms/24 hours transdermal patch 
IME ZDRAVILA Intrinsa 300 mikrogramov/24 ur transdermalni obliž
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Intrinsa 300 micrograms/24 hours transdermal patch Testosterone 
IME ZDRAVILA IN POT(I) UPORABE Intrinsa 300 mikrogramov/24 ur transdermalni obliž Testosteron
The significance of these data for the use of Intrinsa in patients is not known. 
Pomen teh podatkov za uporabo zdravila
Therefore, based on the safety profile in Intrinsa, which requires the submission of 6 monthly PSURs, the CHMP concluded that the MAH should submit one additional renewal application in 5 years time. 
odločil, da mora imetnik dovoljenja za promet z zdravilom čez 5 let predložiti eno dodatno podaljšanje dovoljenja za promet z zdravilom.
6.2 Incompatibilities 
4.3 Kontraindikacije
Breastfeeding Intrinsa must not be used by breast-feeding women. 
Previdnostni ukrepi Zdravila Intrinsa se ne sme uporabljati pri ženskah po naravni menopavzi
Intrinsa is not recommended in naturally 
Uporaba zdravila Intrinsa se ne priporoča ženskam po naravni menopavzi.
- Keep out of the reach and sight of children - Do not use Intrinsa after the expiry date which is stated on the carton and sachet after EXP. 
Zdravila Intrinsa ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in zaščitni vrečici poleg oznake EXP/Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
NAME OF THE MEDICINAL PRODUCT Intrinsa 300 micrograms/24 hours transdermal patch Testosterone 
NAVODILO ZA UPORABO Intrinsa 300 mikrogramov/24 ur transdermalni obliž Testosteron
They are usually reversible if Intrinsa treatment is 
Če se zdravljenje z zdravilom Intrinsa prekine, so ti neželeni učinki navadno prehodni.
Insomnia 
Intrinsa.
Always use Intrinsa exactly as your doctor has told you. 
Pri uporabi zdravila Intrinsa natančno upoštevajte zdravnikova navodila.
Nasal congestion, throat tightness 
Psihiatrične motnje nespečnost razdražljivost, tesnoba
Oral use blister OPA/alu/PVC/alu 7 tablets 
3 mg filmsko obložena tableta peroralna uporaba pretisni omot OPA/alu/PVC/alu
3 mg 
7 tablet
It is a radiopharmaceutical (a medicine that emits a small amount of radioactivity). 
Je radiofarmak (zdravilo, ki oddaja majhno količino radioaktivnosti).
The patient cannot leave the controlled areas until told to do so by the doctor. 
Bolnik ne sme zapustiti nadzorovanega okolja, dokler mu tega ne dovoli zdravnik.
What measures are being taken to ensure the safe and effective use of Lutathera? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lutathera?
Lutathera must not be given to women who are pregnant or in whom pregnancy has not been excluded. 
Zdravila Lutathera ne smejo prejemati nosečnice ali ženske, pri katerih nosečnost ni bila izključena.
The usual treatment involves 4 infusions 8 weeks apart, but the gap between infusions can be increased to up to 16 weeks if the patient gets severe side effects. 
Običajno zdravljenje vključuje štiri infuzije v osemtedenskem razmiku, vendar se razmik med infuzijami lahko podaljša na do 16 tednov, če se pri bolniku pojavijo resni neželeni učinki.
This is a summary of the European public assessment report (EPAR) for Lutathera. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Lutathera.
The radioactivity it emits then kills the tumour cells it is attached to but has little effect on neighbouring cells. 
Radioaktivnost, ki jo oddaja, nato uniči tumorske celice, na katere je vezan, na sosednje celice pa ima le malo vpliva.
In a main study of 229 patients with GEP-NETs that contained somatostatin receptors, patients given Lutathera lived for an average of 28 months without their disease getting worse. 
V glavni študiji z 229 bolniki z gastroenteropankreatičnimi nevroendokrinimi tumorji, ki so vsebovali somatostatinske receptorje, so bolniki, ki so prejemali zdravilo Lutathera, v povprečju živeli 28 mesecev, ne da bi se njihova bolezen poslabšala.
Other common side effects affecting more than 1 in 10 patients are thrombocytopenia (low platelet counts), lymphopenia (low levels of lymphocytes, a type of white blood cell), anaemia (low red cell counts), pancytopenia (low levels of all types of blood cells), tiredness and reduced appetite. 
Drugi pogosti neželeni učinki, ki se pojavijo pri več kot 1 bolniku od 10, so trombocitopenija (nizko število trombocitov), limfopenija (nizka raven limfocitov, vrste belih krvnih celic), anemija (nizko število rdečih krvnih celic), pancitopenija (nizka raven vseh vrst krvnih celic), utrujenost in zmanjšan apetit.
Other information about Lutathera 
Druge informacije o zdravilu Lutathera
The company that markets Lutathera will put in place an educational programme for patients to ensure they understand the risk of radioactivity and precautions they should take to limit exposure to themselves and people around them. 
Družba, ki trži zdravilo Lutathera, bo pripravila izobraževalni program za bolnike, s katerim bo zagotovila, da bodo dobro razumeli tveganja radioaktivnosti in previdnostne ukrepe, ki jih morajo upoštevati, da omejijo izpostavljenost sebe in ljudi okrog sebe.
It must also not be given to patients with severely reduced kidney function. 
Prav tako se ne sme uporabljati pri bolnikih s hudo okvaro delovanja ledvic.
Before starting treatment, the doctor will have checked that the patient's tumours have somatostatin receptors on their cell surfaces. 
Pred začetkom zdravljenja bo zdravnik preveril, ali imajo bolnikovi tumorji na celični površini somatostatinske receptorje.
For further information, including information on the precise method for giving the infusions, see the package leaflet. 
Za več informacij, vključno z informacijami o konkretnem načinu dajanja infuzij, glejte navodilo za uporabo.
Because Lutathera emits some radioactivity, it is only used in special controlled areas and must be handled and given to patients by qualified personnel. 
Ker zdravilo Lutathera oddaja določeno količino radioaktivnosti, se daje samo v posebnih, nadzorovanih okoljih, z njim pa mora ravnati in ga bolnikom dajati usposobljeno osebje.
The summary of the opinion of the Committee for Orphan Medicinal Products for Lutathera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Povzetek mnenja Odbora za zdravila sirote o zdravilu Lutathera je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The patient should also be given an infusion of an amino acid solution which helps protect their kidneys. 
Bolnik mora prejeti tudi infuzijo raztopine aminokislin, ki zaščiti njegove ledvice.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lutathera have also 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 Lutathera upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
What benefits of Lutathera have been shown in studies? 
Kakšne koristi je zdravilo Lutathera izkazalo v študijah?
The most common side effects seen with Lutathera treatment are nausea and vomiting, which occurred at the start of the infusions in around half of patients and may be related to the amino acid infusion. 
Najpogostejša neželena učinka zdravljenja z zdravilom Lutathera sta navzea in bruhanje, ki sta se pojavila na začetku dajanja infuzij pri približno polovici bolnikov in sta morda povezana z infuzijo aminokislin.
It is not intended to provide practical advice on how to use Lutathera. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Lutathera is used is to treat GEP-NETs that cannot be removed by surgery, have spread to other parts of the body or are not responding to treatment. 
Zdravilo Lutathera se uporablja za zdravljenje gastroenteropankreatičnih nevroendokrinih tumorjev, ki jih ni mogoče kirurško odstraniti, ki so se že razširili na druge dele telesa ali se ne odzivajo na zdravljenje.
What is Lutathera and what is it used for? 
Kaj je zdravilo Lutathera in za kaj se uporablja?
Because the number of patients with GEP-NETs is low, they are considered ‘rare', and Lutathera was designated an ‘orphan medicine' (a medicine used in rare diseases) on 31 January 2008. 
Ker je bolnikov z gastroenteropankreatičnimi nevroendokrinimi tumorji malo, velja ta bolezen za redko, zato je bilo zdravilo Lutathera 31. januarja 2008 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih boleznih).
For more information about treatment with Lutathera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Lutathera preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What are the risks associated with Lutathera? 
Kakšna tveganja so povezana z zdravilom Lutathera?
Lutathera can help slow the worsening of the condition and its side effects are considered manageable. 
Zdravilo Lutathera lahko pomaga upočasniti poslabšanje stanja, njegovi neželeni učinki pa veljajo za obvladljive.
Only a minority of patients with GEP-NETs can be cured with surgery and at the time of diagnosis the tumours would have spread in most patients. 
Le manjši delež bolnikov z gastroenteropankreatičnimi nevroendokrinimi tumorji se lahko zdravi kirurško, pri večini bolnikov pa so tumorji v času diagnoze že razširjeni.
The full EPAR for Lutathera 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 Lutathera je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Why is Lutathera approved? 
Zakaj je bilo zdravilo Lutathera odobreno?
For practical information about using Lutathera, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Lutathera naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Lutathera is a cancer medicine for treating tumours in the gut known as gastroenteropancreatic neuroendocrine tumours (GEP-NETs). 
Lutathera je zdravilo proti raku, ki se uporablja za zdravljenje tumorjev v prebavilih, znanih kot gastroenteropankreatični nevroendokrini tumorji (GEP-NET).
For the full list of all side effects reported with Lutathera, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Lutathera, glejte navodilo za uporabo.
This compares with around 9 months for patients treated with octreotide, a medicine already approved for treating the condition. 
Pri bolnikih, ki so se zdravili z oktreotidom, zdravilom, ki je že odobreno za zdravljenje te bolezni, je bilo to obdobje dolgo približno 9 mesecev.
Lutathera contains the active substance lutetium (177Lu) oxodotreotide. 
Zdravilo Lutathera vsebuje zdravilno učinkovino lutecijev (177Lu) oksodotreotid.
The European Medicines Agency considered that the benefits seen with Lutathera outweigh its risks and recommended it be approved in the EU. 
Evropska agencija za zdravila je zaključila, da koristi zdravila Lutathera odtehtajo z njim povezano tveganje, in priporočila, da se zanj izda dovoljenje za promet.
The active substance in Lutathera, lutetium (177Lu) oxodotreotide, works by attaching to somatostatin receptors, which are found in high numbers in some GEP-NETs. 
Zdravilna učinkovina v zdravilu Lutathera, lutecijev (177Lu) oksodotreotid, deluje z vezavo na somatostatinske receptorje, ki so v velikem številu prisotni na nekaterih gastroenteropankreatičnih nevroendokrinih tumorjih.
How does Lutathera work? 
Kako zdravilo Lutathera deluje?
Lutathera is given by infusion (drip) into a vein. 
Zdravilo Lutathera se daje z infundiranjem (kapalno infuzijo) v veno.
The medicine is only for GEP-NETs that have receptors called somatostatin receptors on their cell surfaces. 
Zdravilo je namenjeno samo za gastroenteropankreatične nevroendokrine tumorje, ki imajo na celični površini receptorje, imenovane somatostatinski receptorji.
How is Lutathera used? 
Kako se zdravilo Lutathera uporablja?
Lutathera can help slow down the worsening of GEP-NETs. 
Zdravilo lahko pomaga upočasniti poslabšanje gastroenteropankreatičnih nevroendokrinih tumorjev.
They are taken once a day. 
Jemljejo se enkrat na dan.
The European Commission issued a decision on this opinion on 20 December 2010. 
Evropska komisija je odločbo v zvezi s tem mnenjem izdala dne 20. decembra 2010.
It is used to treat severe pain. 
Uporablja se za zdravljenje hude bolečine.
Ethirfin was authorised in the European Union (EU) under a mutual recognition procedure on the basis of the initial authorisation granted by Denmark on 15 July 2005. 
Zdravilo Ethirfin je bilo odobreno v Evropski uniji (EU) s postopkom medsebojnega priznavanja na podlagi prvotnega dovoljenja za promet, odobrenega na Danskem dne 15. julija 2005.
This renewal was to be recognised in Germany, Ireland, Italy and the United Kingdom (the ‘concerned Member States'). 
Podaljšanje dovoljenja za promet z zdravilom naj bi priznali v Nemčiji, na Irskem, v Italiji in Združenem kraljestvu („zadevne države članice“).
Why was Ethirfin reviewed? 
Zakaj je bilo zdravilo Ethirfin pregledano?
Because these Member States were not able to reach an agreement, the German and United Kingdom medicines regulatory agencies referred the matter to the CHMP for arbitration on 30 October 2009. 
Ker navedene države članice niso mogle doseči soglasja, sta regulativni agenciji za zdravila v Nemčiji in Združenem kraljestvu dne 30. oktobra 2009 zadevo napotili na CHMP v arbitražo.
Ethirfin is a medicine that contains the active substance morphine sulphate. 
Ethirfin je zdravilo, ki vsebuje zdravilno učinkovino morfinijev sulfat.
The European Medicines Agency has completed an arbitration procedure for Ethirfin and associated names. 
Evropska agencija za zdravila je zaključila arbitražni postopek za zdravilo Ethirfin in povezana imena.
Therefore the benefits of Ethirfin do not outweigh its risks, and the marketing authorisation for Ethirfin should not be renewed in all concerned Member States. 
Koristi zdravila Ethirfin tako ne odtehtajo z njim povezanih tveganj, zato se dovoljenje za promet z zdravilom Ethirfin ne sme podaljšati v vseh zadevnih državah članicah.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that there is a significant interaction between Ethirfin and alcohol, and that patients taking Ethirfin and alcohol are at risk of developing serious side effects. 
Na podlagi vrednotenja trenutno razpoložljivih podatkov in znanstvene razprave v Odboru je CHMP sklenil, da obstaja pomembno medsebojno delovanje med zdravilom Ethirfin in alkoholom ter da se lahko pri bolnikih, ki jemljejo zdravilo Ethirfin z alkoholom, pojavijo hudi neželeni učinki.
Questions and answers on Ethirfin and associated names (morphine sulphate, prolonged-release capsules, 20, 60, 120 and 200 mg) 
Vprašanja in odgovori v zvezi z zdravilom Ethirfin in povezanimi imeni (morfinijev sulfat, kapsule s podaljšanim sproščanjem, 20, 60, 120 in 200 mg)
What is Ethirfin? 
Kaj je zdravilo Ethirfin?
The grounds for the referral were concerns that the active substance in the capsules could be released too quickly if the capsules are taken with alcohol, because they contain a ‘polymethacrylatetriethylcitrate' coating to control the release of morphine and this coating is soluble in alcohol. 
Podlaga za napotitev so bili zadržki, da se lahko zdravilna učinkovina iz kapsul sprosti prehitro, če se kapsule jemljejo z alkoholom, saj so kapsule obložene s „polimetakrilat-trietilcitratom“, ki uravnava sproščanje morfina, ta obloga pa je v alkoholu topljiva.
The company applied for the marketing authorisation to be renewed in Denmark (the ‘reference Member State'). 
Družba je vlogo za podaljšanje prometa z zdravilom predložila na Danskem („referenčna država članica“).
The Agency's Committee for Medicinal Products for Human Use (CHMP) had been asked to arbitrate on the renewal of the marketing authorisation for Ethirfin. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji so zaprosili, da sprejme odločitev o podaljšanju dovoljenja za promet z zdravilom Ethirfin.
Questions and answers on Ethirfin and associated names (morphine sulphate, prolonged-release capsules, 20, 60, 120 and 200 mg) EMA/297829/2011 
Vprašanja in odgovori v zvezi z zdravilom Ethirfin in povezanimi imeni (morfinijev sulfat, kapsule s podaljšanim sproščanjem, 20, 60, 120 in 200 mg) EMA/276994/2011
The Committee concluded that the marketing authorisation should not be renewed, as patients taking Ethirfin and alcohol are at risk of developing serious side effects. 
Odbor je sklenil, da se dovoljenje za promet z zdravilom ne sme podaljšati, saj pri bolnikih, ki jemljejo zdravilo Ethirfin in alkohol, obstaja tveganje za pojav hudih neželenih učinkov.
Ethirfin is available as ‘prolonged-release' capsules that release the active substance slowly. 
Zdravilo Ethirfin je na voljo v obliki kapsul s podaljšanim sproščanjem, ki počasi sproščajo zdravilno učinkovino.
The rapid release of the active substance is called ‘dose dumping' and could put patients at risk of exposure to large doses of morphine, leading to side effects such as respiratory depression (an inhibition of breathing). 
odmerkov morfina, kar lahko povzroči neželene učinke, na primer respiratorno depresijo (zmanjšanje dihanja).
Annex IV Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations, as relevant 
Znanstveni zaključki in podlaga za ohranitev dovoljenj za promet z zdravilom ali spremembo pogojev dovoljenj za promet z zdravilom, kot je ustrezno
This finding was maintained after 96 weeks. 
Ti rezultati so ostali enaki tudi po 96 tednih.
The European Commission granted a marketing authorisation valid throughout the European Union for Reyataz on 2 March 2004. 
Evropska komisija je dovoljenje za promet z zdravilom Reyataz, veljavno po vsej Evropski uniji, izdala 2. marca 2004.
What measures are being taken to ensure the safe and effective use of Reyataz? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Reyataz?
It is available as capsules (100 mg, 150 mg, 200 mg and 300 mg) and oral powder (50 mg). 
Na voljo je v obliki kapsul (100 mg, 150 mg, 200 mg in 300 mg) in peroralnega praška (50 mg).
The full EPAR for Reyataz 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 Reyataz je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
More than half of these patients had taken HIV treatment in the past. 
Približno polovica teh bolnikov je predhodno že prejemala zdravila proti virusu HIV.
What benefit has Reyataz shown during the studies? 
Kakšne koristi je zdravilo Reyataz izkazalo med študijami?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Reyataz have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Reyataz, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
For more information about treatment with Reyataz, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Reyataz preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
In patients who had been treated before, the results of the first study could not be interpreted, as a large number of patients left the study before its planned end. 
Pri predhodno zdravljenih bolnikih rezultatov prve študije ni bilo možno ovrednotiti, ker je veliko število bolnikov sodelovanje v študiji prekinilo še pred njenim načrtovanim zaključkom.
This document is a summary of the European Public Assessment Report (EPAR) for Reyataz. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Reyataz.