natgillin/translations-raw huggingface dataset:
Porcilis Porcoli Diluvac Forte contains adhesins that are found on the surface of E. coli bacteria. 
Zdravilo Porcilis Porcoli Diluvac Forte vsebuje adhezine, ki se nahajajo na površini bakterije E. coli.
Other information about Porcilis Porcoli Diluvac Forte: 
Druge informacije o zdravilu Porcilis Porcoli Diluvac Forte:
Porcilis Porcoli Diluvac Forte is a vaccine for use in pigs. 
Zdravilo Porcilis Porcoli Diluvac Forte je cepivo, ki se uporablja pri prašičih.
Porcilis Porcoli Diluvac Forte is given as a dose of 2 ml by intramuscular (into a muscle) injection to female pigs. 
Zdravilo Porcilis Porcoli Diluvac Forte se daje svinjam v odmerku 2 ml z intramuskularno injekcijo (v mišico).
Porcilis Porcoli Diluvac Forte reduced the death rate in all the studies when compared with the control piglets. 
Zdravilo Porcilis Porcoli Diluvac Forte je v primerjavi s kontrolno skupino pujskov v vseh študijah zmanjšalo smrtnost.
Porcilis Porcoli Diluvac Forte can cause mild, temporary clinical reactions (fever, lethargy, reduced food intake) during the first 24 hours after vaccination. 
Zdravilo Porcilis Porcoli Diluvac Forte lahko v 24 urah po cepljenju povzroči blage prehodne klinične reakcije (povišano telesno temperaturo, zaspanost, zmanjšan tek).
What benefit has Porcilis Porcoli Diluvac Forte shown during the studies? 
Kakšne koristi je zdravilo Porcilis Porcoli Diluvac Forte izkazalo med študijami?
Porcilis Porcoli Diluvac Forte is used to reduce death and clinical signs of enterotoxicosis caused by E. coli bacteria in piglets during the first days of their life. 
Zdravilo Porcilis Porcoli Diluvac Forte se uporablja za zmanjšanje smrtnosti in kliničnih znakov enterotoksikoze pujskov prve dni po rojstvu, ki jo povzroča bakterija E. coli.
Why has Porcilis Porcoli Diluvac Forte been approved? 
Zakaj je bilo zdravilo Porcilis Porcoli Diluvac Forte odobreno?
What are the side effects of Porcilis Porcoli Diluvac Forte? 
Kakšni so neželeni učinki zdravila Porcilis Porcoli Diluvac Forte?
How has the effectiveness of Porcilis Porcoli Diluvac Forte been studied? 
Kako je bila raziskana učinkovitost zdravila Porcilis Porcoli Diluvac
What is Porcilis Porcoli Diluvac Forte? 
Kaj je zdravilo Porcilis Porcoli Diluvac Forte?
How does Porcilis Porcoli Diluvac Forte work? 
Kako zdravilo Porcilis Porcoli Diluvac Forte deluje?
What is Porcilis Porcoli Diluvac Forte used for? 
Za kaj se uporablja zdravilo Porcilis Porcoli Diluvac Forte?
Both active substances have been available in the EU for a number of years. 
Obe učinkovini sta v EU na voljo že vrsto let.
Clopidogrel has been authorised since 1998 as an antiplatelet medicine, and is often used in combination with acetylsalicylic acid. 
Klopidogrel je od leta 1998 odobren kot antiagregacijsko zdravilo in se pogosto uporablja v kombinaciji z acetilsalicilno kislino.
• patients being treated for heart attack with ST-segment elevation, when the doctor thinks that they would benefit from thrombolytic treatment (treatment to dissolve blood clots). 
• pri bolnikih, ki se zdravijo zaradi srčnega napada z dvigom ST spojnice, kadar zdravnik meni, da jim bo trombolitično zdravljenje (zdravljenje s ciljem razgradnje krvnih strdkov) koristilo.
The medicine is available as tablets containing 75 mg clopidogrel, either with 75 mg or 100 mg acetylsalicylic acid and can only be obtained with a prescription. 
Zdravilo je na voljo v obliki tablet, ki vsebujejo 75 mg klopidogrela, bodisi s 75 mg ali 100 mg acetilsalicilne kisline, predpisovanje in izdaja zdravila pa je le na recept.
Further information on Clopidogrel/Acetylsalicylic acid Mylan can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/clopidogrel-acetylsalicylic-acid-mylan. 
Nadaljnje informacije o zdravilu Klopidogrel/acetilsalicilna kislina Mylan so na voljo na spletni strani agencije:ema.europa.eu/medicines/human/EPAR/clopidogrel-acetylsalicylic-acid-mylan.
The combination of the two active substances reduces the risk of blood clots forming more than either medicine alone. 
Kombinacija obeh učinkovin zmanjša tveganje za nastanek krvnih strdkov bolj kot vsako posamično zdravilo.
• patients who have unstable angina (a severe type of chest pain) or who have had a heart attack with no ‘ST-segment elevation' (an abnormal reading on an electrocardiogram), including those who are having a stent (a short tube) inserted into an artery to prevent it from closing up; 
• pri bolnikih, ki imajo nestabilno angino pektoris (hudo vrsto bolečine v prsih) ali so imeli srčni napad brez „elevacije ST spojnice“ (nenormalnega odčitka na elektrokardiogramu), ter pri tistih, ki jim je bila v arterijo vstavljena opornica (kratka cevka), ki preprečuje, da bi se arterija zamašila;
This means that they help to prevent components in the blood called platelets from sticking together and forming clots, thus helping to prevent another heart attack. 
To pomeni, da pomagata preprečevati zlepljanje sestavin v krvi, imenovanih trombociti, in tvorbo strdkov, kar prispeva k preprečitvi novega srčnega napada.
The medicine is taken as one tablet once a day instead of the clopidogrel and acetylsalicylic acid tablets that the patient has already been taking separately. 
Jemlje se kot ena tableta enkrat na dan namesto tablete s klopidogrelom in tablete z acetilsalicilno kislino, ki ju je bolnik pred tem jemal ločeno.
Studies on the benefits and risks of the active substances in the authorised uses have already been carried out with the reference medicine, DuoPlavin, and do not need to be repeated for Clopidogrel/Acetylsalicylic acid Mylan. 
Študije o koristih in tveganjih obeh učinkovin pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom DuoPlavin, zato jih ni treba ponoviti za zdravilo Klopidogrel/acetilsalicilna kislina Mylan.
The European Medicines Agency concluded that, in accordance with EU requirements, Clopidogrel/Acetylsalicylic acid Mylan has been shown to have comparable quality and to be bioequivalent to DuoPlavin. 
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Klopidogrel/acetilsalicilna kislina Mylan primerljivo raven kakovosti in je bioekvivalentno zdravilu DuoPlavin.
Clopidogrel/Acetylsalicylic acid Mylan is a medicine used to prevent problems caused by blood clots and hardening of the arteries, such as a heart attack, in adults who are already taking both clopidogrel and acetylsalicylic acid as separate tablets. 
Klopidogrel/acetilsalicilna kislina Mylan je zdravilo, ki se uporablja za preprečevanje težav, ki jih povzročajo krvni strdki in zatrditev arterij, kot je srčni napad, pri odraslih, ki že jemljejo klopidogrel in acetilsalicilno kislino kot ločeni tableti.
Because Clopidogrel/Acetylsalicylic acid Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Klopidogrel/acetilsalicilna kislina Mylan generično zdravilo in je bioekvivalentno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Clopidogrel blocks a substance called ADP from attaching to a receptor (target) on the surface of platelets. 
Klopidogrel zavira snov, imenovano ADP, da se veže na receptor (prijemališče) na površini trombocitov.
Both active substances in the medicine, clopidogrel and acetylsalicylic acid, are antiplatelet medicines. 
Obe učinkovini zdravila, klopidogrel in acetilsalicilna kislina, sta antiagregacijski zdravili.
Side effects reported with Clopidogrel/Acetylsalicylic acid Mylan are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Klopidogrel/acetilsalicilna kislina Mylan, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Clopidogrel/Acetylsalicylic acid Mylan have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Klopidogrel/acetilsalicilna kislina Mylan upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
For more information about using Clopidogrel/Acetylsalicylic acid Mylan, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Klopidogrel/acetilsalicilna kislina Mylan glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
As for every medicine, the company provided studies on the quality of Clopidogrel/Acetylsalicylic acid Mylan. 
Tako kot za vsako zdravilo, je podjetje predložilo študije o kakovosti zdravila Klopidogrel/acetilsalicilna kislina Mylan.
Clopidogrel/Acetylsalicylic acid Mylan contains two active substances, clopidogrel and acetylsalicylic acid (also known as aspirin) and is a ‘generic medicine'. 
Zdravilo Klopidogrel/acetilsalicilna kislina Mylan vsebuje dve učinkovini, klopidogrel in acetilsalicilno kislino (znano tudi kot aspirin) in je „generično zdravilo“.
Acetylsalicylic acid blocks an enzyme called prostaglandin cyclo-oxygenase. 
Acetilsalicilna kislina zavira encim, imenovan prostaglandin ciklooksigenaza.
What measures are being taken to ensure the safe and effective use of Clopidogrel/Acetylsalicylic acid Mylan? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Klopidogrel/acetilsalicilna kislina Mylan?
An overview of Clopidogrel/Acetylsalicylic acid Mylan and why it is authorised in the EU 
Pregled zdravila Klopidogrel/acetilsalicilna kislina Mylan in zakaj je odobreno v EU
This means that Clopidogrel/Acetylsalicylic acid Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called DuoPlavin. 
To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje DuoPlavin.
As for all medicines, data on the use of Clopidogrel/Acetylsalicylic acid Mylan are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Klopidogrel/acetilsalicilna kislina Mylan stalno spremljajo.
What are the benefits and risks of Clopidogrel/Acetylsalicylic acid Mylan? 
Kakšne so koristi in tveganja, povezani z zdravilom Klopidogrel/acetilsalicilna kislina Mylan?
Why is Clopidogrel/Acetylsalicylic acid Mylan authorised in the EU? 
Zakaj je bilo zdravilo Klopidogrel/acetilsalicilna kislina Mylan odobreno v EU?
Other information about Clopidogrel/Acetylsalicylic acid Mylan 
Druge informacije o zdravilu Klopidogrel/acetilsalicilna kislina Mylan
Therefore, the Agency's view was that, as for DuoPlavin, the benefits of Clopidogrel/Acetylsalicylic acid Mylan outweigh the identified risks and it can be authorised for use in the EU. 
Zato je agencija menila, da koristi zdravila Klopidogrel/acetilsalicilna kislina Mylan enako kot pri zdravilu DuoPlavin odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
What is Clopidogrel/Acetylsalicylic acid Mylan and what is it used for? 
Kaj je zdravilo Klopidogrel/acetilsalicilna kislina Mylan in za kaj se uporablja?
Clopidogrel/Acetylsalicylic acid Mylan (clopidogrel / acetylsalicylic acid) 
Klopidogrel/acetilsalicilna kislina Mylan (klopidogrel/acetilsalicilna kislina)
How does Clopidogrel/Acetylsalicylic acid Mylan work? 
Kako zdravilo Klopidogrel/acetilsalicilna kislina Mylan deluje?
How is Clopidogrel/Acetylsalicylic acid Mylan used? 
Kako se zdravilo Klopidogrel/acetilsalicilna kislina Mylan uporablja?
How has Clopidogrel/Acetylsalicylic acid Mylan been studied? 
Kako je bilo zdravilo Klopidogrel/acetilsalicilna kislina Mylan raziskano?
Multi-dose vial (glass) 
Večodmerna viala (steklena)
Ref. EMEA/654674/2009 EMEA/H/C/994 
: EMEA/745166/2009 EMEA/H/C/994
The main measure of effectiveness was how long the patients lived. 
Glavno merilo učinkovitosti je bilo trajanje preživetja bolnikov.
Paclitaxel is an anticancer medicine which has been available in the European Union since 1993. 
Paklitaksel je zdravilo proti raku, ki je v Evropski uniji na voljo od leta 1993.
A performance status of 2 means that the patient can take care of him or herself without help but is too ill to do any work. 
Telesna zmogljivost 2 pomeni, da bolnik lahko skrbi zase brez pomoči, vendar je preveč bolan za delo.
The company informed the CHMP that the withdrawal has no impact on patients in the European Union (EU) as there are no ongoing clinical trials or compassionate use programmes in the EU. 
Družba je CHMP obvestila, da umik nima vpliva na bolnike v Evropski uniji (EU), saj klinična preskušanja in programi sočutne uporabe v EU trenutno ne potekajo.
The CHMP also had concerns about the side effects of the medicine, especially neuropathy (damage to the nerves) and unexplained deaths. 
Odbor je imel zadržke tudi glede neželenih učinkov zdravila, zlasti nevropatij (poškodb živčevja) in nerazloženih smrti.
The letter from the company notifying the CHMP of the withdrawal of the application is available here 
Dopis, s katerim družba CHMP obvešča o umiku vloge, je na voljo tukaj.
In this study, Opaxio was compared with gemcitabine or vinorelbine (two other anticancer medicines). 
V tej študiji so zdravilo Opaxio primerjali z gemcitabinom ali vinorelbinom (dvema drugima zdraviloma proti raku).
The effects of Opaxio were first tested in experimental models before being studied in humans. 
Učinki zdravila Opaxio so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Opaxio? 
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Opaxio?
There were also concerns about impurities in the medicine and about the way paclitaxel is released and distributed in the body when Opaxio is given. 
Obstajali so tudi zadržki o nečistočah v zdravilu in o načinu sproščanja paklitaksela ter njegovi porazdelitvi v telesu po uporabi zdravila Opaxio.
However, outside the EU, the company is continuing to study Opaxio in several cancers including ovarian, oesophageal and non-small cell lung cancer. 
Družba pa izven EU nadaljuje s preučevanjem zdravila Opaxio na različnih vrstah raka, vključno z rakom jajčnikov, požiralnika in nedrobnoceličnim pljučnim rakom.
The company's view that the study showed that Opaxio was as least as good as the comparators was not accepted by the Committee because it was not clear that the comparators themselves were effective in the type of patients involved in the main study. 
Mnenja družbe, da so v študiji dokazali, da je zdravilo Opaxio vsaj enako dobro kot primerjana zdravila, Odbor ni sprejel, ker ni bilo jasno, ali so primerjana zdravila sama po sebi učinkovita pri vrsti bolnikov, ki so sodelovali v omenjeni študiji.
The ECOG performance status is a measure of how ill a cancer patient is. 
Telesna zmogljivost po lestvici ECOG je merilo, kako bolan je bolnik z rakom.
How is Opaxio expected to work? 
Kako naj bi zdravilo Opaxio delovalo?
The company presented results of one main study involving 477 patients with advanced non-small cell lung cancer and a performance status of 2. 
Družba je predložila rezultate ene glavne študije, v katero je bilo vključenih 477 bolnikov z napredovalim nedrobnoceličnim pljučnim rakom in telesno zmogljivostjo 2.
Paclitaxel works by blocking the ability of cancer cells to break down the internal ‘skeleton' that allows them to divide and multiply. 
Paklitaksel rakavim celicam prepreči razgrajevanje notranjega „ogrodja“, ki jim omogoča delitev in razmnoževanje.
The active substance in Opaxio, paclitaxel poliglumex, is expected to be converted into paclitaxel in the cancer cells. 
Zdravilna učinkovina v zdravilu Opaxio, paklitaksel poliglumeks, naj bi se v rakavih celicah pretvorila v paklitaksel.
On 21 September 2009, CTI Life Sciences Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Opaxio, for the first-line treatment of patients with advanced non-small cell lung cancer who have an ECOG performance status of 2. 
Družba CTI Life Sciences Ltd je dne 21. septembra 2009 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Opaxio, zdravilom prve izbire za zdravljenje napredovalega nedrobnoceličnega pljučnega raka pri bolnikih, ki imajo telesno zmogljivostjo po lestvici ECOG enako 2.
In addition, the studies did not show that Opaxio was more effective than the two comparators. 
Poleg tega v študijah niso dokazali, da je zdravilo Opaxio učinkovitejše od dveh primerjanih zdravil.
Questions and answers on the withdrawal of the marketing authorisation application for Opaxio paclitaxel poliglumex 
Vprašanja in odgovori v zvezi z umikom vloge za pridobitev dovoljenja za promet z zdravilom Opaxio paklitaksel poliglumeks
It contains the active substance paclitaxel poliglumex. 
Vsebuje zdravilno učinkovino paklitaksel poliglumeks.
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Opaxio could not have been approved for the first-line treatment of patients with advanced non-small cell lung cancer who have an ECOG performance status of 2. 
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila Opaxio ni mogoče odobriti kot zdravila prve izbire za zdravljenje napredovalega nedrobnoceličnega pljučnega raka pri bolnikih, ki imajo telesno zmogljivostjo po lestvici ECOG enako 2.
Opaxio was expected to be used in patients with advanced non-small cell lung cancer who have an ECOG performance status of 2. 
Zdravilo Opaxio naj bi se uporabljalo za bolnike z napredovalim nedrobnoceličnim pljučnim rakom, ki imajo telesno zmogljivostjo po lestvici ECOG enako 2.
The CHMP noted that the main study did not show that Opaxio was effective in patients with advanced non-small cell lung cancer who have an ECOG performance status of 2. 
CHMP je izpostavil, da v glavni študiji niso dokazali, da je zdravilo Opaxio učinkovito pri bolnikih z napredovalim nedrobnoceličnim pljučnim rakom in telesno zmogljivostjo 2 po lestvici ECOG.
Opaxio is a powder that is made up into a solution for infusion (drip into a vein). 
Zdravilo Opaxio je prašek za pripravo raztopine za infundiranje (kapalne infuzije v veno).
What was Opaxio expected to be used for? 
Za kaj naj bi se zdravilo Opaxio uporabljalo?
In Opaxio, paclitaxel is attached to poliglumex to make it more soluble. 
Paklitaksel v zdravilu Opaxio se veže na poliglumeks, da ima boljšo topnost.
Femara was first approved in the European Union (EU) in 1996 and is available as a 2.5 mg film-coated tablet. 
Zdravilo Femara je bilo v Evropski uniji (EU) prvič odobreno leta 1996 in je na voljo v obliki 2,5 mg filmsko obloženih tablet.
The CHMP moved the statement from Section 4.4 to Section 5.1. 
CHMP je izjavo prestavil iz poglavja 4.4 v poglavje 5.1.
In particular, for Section 4.8 - Undesirable Effects, the wording was significantly shortened and condensed. 
Zlasti za poglavje 4.8 - Neželeni učinki je bilo besedilo močno skrajšano in zgoščeno.
A referral under Article 30(2) of Directive 2001/83/EC, as amended was therefore triggered to resolve these divergences and thus harmonise the product information (PI) across the EU. 
Zato je bila na podlagi člena 30 (2) Direktive 2001/83/ES, kakor je bila spremenjena, sprožena napotitev za razrešitev teh razhajanj in s tem uskladitev informacij o zdravilu v EU.
In conclusion, the following harmonised indications were adopted for Femara: 
Na koncu so bile sprejete naslednje usklajene indikacije za zdravilo Femara:
Overall summary of the scientific evaluation of Femara and associated names (see Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravila Femara in z njim povezanih imen (glejte Prilogo I)
The CHMP therefore considered it justified to qualify the indication with “invasive”. 
Zato je CHMP menil, da lahko indikacijo upravičeno označimo z „invazivno“.
While a contraindication in these patients was not warranted, the CHMP inserted a precaution. 
Čeprav kontraindikacija pri teh bolnikih ni bila utemeljena, je CHMP vključil previdnostni ukrep.
Women with a history of fractures and/or osteoporosis experienced higher rates of bone fractures than women without such a history, irrespective of treatment. 
Ženske z anamnezo zlomov in/ali osteoporoze so imele pogostejše zlome kosti kot ženske brez takšne anamneze, ne glede na zdravljenje.
In addition, no studies on DCIS (ductal carcinoma in situ) or LCIS (lobular carcinoma in situ) patients have been performed. 
Poleg tega niso bile opravljene študije pri bolnicah z DCIS (duktalni karcinom in situ) ali LCIS (lobularni karcinom in situ).
The CHMP therefore added a statement regarding bone effects associated with the use of Femara. 
Zato je CHMP dodal izjavo glede učinkov na kosti, povezanih z uporabo zdravila Femara.
The CHMP considered that reviews of clinical databases are poorly suited to assess the risk for interactions or to assess reports of lack of interaction and therefore removed references to these reviews. 
CHMP je menil, da pregledi kliničnih podatkovnih baz niso primerni za oceno tveganja za interakcije ali za oceno poročil o pomanjkanju interakcije, zato je odstranil sklicevanje na te preglede.
Having considered the data submitted by the Marketing Authorisation Holder, the rapporteur and co-rapporteur assessment reports and the scientific discussions within the Committee, the CHMP was of the opinion that the benefit-risk ratio of Femara and associated names is favourable. 
Po preučitvi podatkov, ki jih je predložil imetnik dovoljenja za promet z zdravilom, poročil o oceni, ki sta jih priskrbela poročevalec in soporočevalec, in znanstvenih razprav v Odboru, je CHMP menil, da je razmerje med koristmi in tveganji za zdravilo Femara in z njim povezanih imen ugodno.
Regarding children, invasive breast cancer is extremely rare in children and adolescents but has been reported. 
Pri otrocih in mladostnikih je invazivni rak dojke izredno redek, čeprav so že poročali o njem.
The CHMP also added a warning that oestrogens and/or tamoxifen may reduce letrozole plasma levels, thus reducing its pharmacological action, and that co-administration should therefore be avoided. 
CHMP je dodal opozorilo tudi, da lahko estrogeni in/ali tamoksifen zmanjšajo ravni letrozola v plazmi, kar zmanjšuje njegovo farmakološko delovanje, zato se je treba izogibati sočasni uporabi.
Regarding adjuvant and extended adjuvant treatment, studies show that efficacy was sustained over the median duration of 5 years of treatment. 
Glede adjuvantnega in podaljšanega adjuvantnega zdravljenja študije kažejo, da se je učinkovitost zdravila ohranila za mediano trajanje zdravljenja 5 let.
Regarding duration of treatment, the CHMP considered that studies show that Femara treatment should be continued until further progression of disease becomes evident. 
Glede trajanje zdravljenja je CHMP menil, da študije kažejo, da je treba zdravljenje z zdravilom Femara nadaljevati, dokler se ne pokaže napredovanje bolezni.
Regarding the description of selected adverse reactions, the CHMP agreed to separate the metastatic, adjuvant and extended adjuvant indications. 
Glede opisa izbranih neželenih učinkov se je CHMP strinjal, da se ločijo metastatske, adjuvantne in podaljšane adjuvantne terapije.
Regarding “invasive”, it is not common practice to prescribe aromatase inhibitors to patients with no invasive component. 
Glede „invazivnega“ se zaviralcev aromataze v splošni praksi ne predpisuje bolnicam brez invazivne komponente.