FrancophonIA/ELRC3.0 huggingface dataset:
English: o The need to report any symptoms of visual impairment immediately to the prescriber during and for up to two months after the end of treatment with GILENYA.
Slovenian: o Pomembnost takojšnjega obveščanja lečečega zdravnika, če pride do simptomov okvare vida v času zdravljenja in še najmanj dva meseca po prekinitvi zdravljenja z zdravilom GILENYA.
English: o Perform blood pressure measurement prior to the first dose of GILENYA (or when the last dose of GILENYA was more than two weeks previously).
Slovenian: o Bolniku je treba izmeriti krvni tlak pred prejemom prvega odmerka zdravila GILENYA (ali v primeru, da sta pred tem od zadnjega odmerka zdravila GILENYA minila že več kot dva tedna).
English: o GILENYA is not recommended in patients with cardiac disease or those taking medicines concomitantly known to decrease heart rate and they should tell any doctor they see that they are being treated with GILENYA.
Slovenian: o Uporaba zdravila GILENYA ni priporočena za bolnike, ki imajo katero od srčnih bolezni ali sočasno jemljejo zdravila, za katera vemo, da znižujejo srčno frekvenco.
English: o GILENYA may increase the risk of infections.
Slovenian: o Zdravilo GILENYA lahko poveča tveganje za okužbe, zato je treba pri bolnikih s hudo aktivno okužbo odložiti začetek zdravljenja do ozdravitve.
English: o The need for ophthalmological assessment during treatment with GILENYA in patients with diabetes mellitus or with a history of uveitis.
Slovenian: o Pri bolnikih s sladkorno boleznijo ali z anamnezo uveitisa je treba med zdravljenjem z zdravilom GILENYA opraviti oftalmološki pregled.
English: o The need to instruct patients to report signs and symptoms of infections immediately to their prescriber during and for up to two months after treatment with GILENYA.
Slovenian: o Bolnikom je treba naročiti, naj v času zdravljenja in do dva meseca po zaključku zdravljenja z zdravilom GILENYA svojega zdravnika takoj obvestijo, če opazijo kakršnekoli znake ali simptome okužbe.
English: o Arrange ophthalmological assessment prior to initiation with GILENYA in patients with diabetes mellitus or with a history of uveitis.
Slovenian: o Bolniki s sladkorno boleznijo ali z anamnezo uveitisa morajo pred začetkom zdravljenja z zdravilom GILENYA opraviti oftalmološki pregled.
English: EMA/351429/2015 EMEA/H/C/003840
Slovenian: EMA/351429/2015
English: This increases the ability of the immune system to kill cancer cells.
Slovenian: S tem poveča sposobnost imunskega sistema za ubijanje rakavih celic.
English: The full EPAR and risk management plan summary for Nivolumab BMS 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 Nivolumab BMS sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Nivolumab BMS.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Nivolumab BMS.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Nivolumab BMS'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 Nivolumab BM večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: The average survival among 135 patients given Nivolumab BMS was around 9 months, whereas among the 137 patients given docetaxel it was 6 months.
Slovenian: Povprečno preživetje med 135 bolniki, ki so prejemali zdravilo Nivolumab BMS, je bilo približno 9 mesecev, med 137 bolniki, ki so prejemali docetaksel, pa 6 mesecev.
English: A risk management plan has been developed to ensure that Nivolumab BMS is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Nivolumab BMS je bil pripravljen načrt obvladovanja tveganj.
English: The most common side effects with Nivolumab BMS (which may affect more than 1 in 10 people) are tiredness, decreased appetite, and nausea (feeling sick), which are mostly mild or moderate in severity.
Slovenian: Najpogostejši neželeni učinki zdravila Nivolumab BMS (ki lahko prizadenejo več kot 1 osebo od 10) so utrujenost, zmanjšan tek in navzeja (slabost), ki so po resnosti večinoma blagi ali zmerni.
English: The company will also provide an alert card for patients with information on the risks of the medicine, as well as instructions on when to contact their doctor if they experience symptoms of side effects.
Slovenian: Družba bo priskrbela tudi opozorilno kartico za bolnike, ki bo vsebovala informacije o tveganjih tega zdravila in navodila, kdaj se posvetovati z zdravnikom, če se pojavijo simptomi stranskih učinkov.
English: Treatment with Nivolumab BMS was compared with another cancer medicine, docetaxel, and the main measure of effectiveness was overall survival (how long patients lived).
Slovenian: Zdravljenje z zdravilom Nivolumab BMS so primerjali z drugim zdravilom za zdravljenje raka, docetakselom, glavno merilo učinkovitosti pa je bilo celokupno preživetje (kako dolgo so bolniki živeli).
English: Other information about Nivolumab BMS
Slovenian: Druge informacije o zdravilu Nivolumab BMS
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in certain cells in the body.
Slovenian: Monoklonsko protitelo je protitelo (vrsta beljakovine), ki deluje tako, da prepozna in se veže na določeno strukturo (imenovano antigen), ki se nahaja v nekaterih celicah v telesu.
English: It will also conduct further studies on the long-term benefits of Nivolumab BMS, and try to identify which patients are most likely to benefit from treatment with the medicine.
Slovenian: Družba bo opravila tudi dodatne študije o dolgotrajni koristi zdravila Nivolumab BMS in poskušala ugotoviti, katerim bolnikom bo zdravljenje s tem zdravilom najverjetneje koristilo.
English: Patients whose cancer clearly expressed PD-1 seem to show most benefit, but as other patients also responded, further study to clarify patient groups most likely to benefit from the medicine is needed.
Slovenian: Največjo korist so opazili pri bolnikih z jasno izraženim receptorjem PD-1, ker pa so se odzivali tudi drugi bolniki, so potrebne nadaljnje študije za določitev skupin bolnikov, za katere je najverjetneje, da jim bo zdravilo koristilo.
English: The medicine is available as a concentrate for making up a solution for infusion (drip) into a vein.
Slovenian: Zdravilo je na voljo v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: Nivolumab BMS is a cancer medicine used to treat adults with a type of lung cancer called squamous non-small cell lung cancer (NSCLC).
Slovenian: Nivolumab BMS je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje odraslih bolnikov z vrsto pljučnega raka, ki se imenuje ploščatocelični nedrobnocelični pljučni karcinom (NSCLC).
English: Nivolumab BMS is also commonly associated with side effects related to the activity of the immune system on body organs.
Slovenian: Zdravilo Nivolumab BMS je pogosto povezano tudi z neželenimi učinki, ki prizadenejo delovanje imunskega sistema na organe.
English: What measures are being taken to ensure the safe and effective use of Nivolumab BMS?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe
English: Supportive information was also provided from another study indicating that Nivolumab BMS could produce a response in patients whose disease had progressed despite several previous treatments.
Slovenian: Predloženi so bili tudi podporni podatki iz druge študije, ki kažejo, da lahko zdravilo Nivolumab BMS povzroči odziv pri bolnikih, pri katerih je bolezen napredovala kljub
English: For further information, see the package leaflet.
Slovenian: Za več informacij glejte
English: For more information about treatment with Nivolumab BMS, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Nivolumab BMS preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali
English: The active substance in Nivolumab BMS is a monoclonal antibody.
Slovenian: Zdravilna učinkovina v zdravilu Nivolumab BMS je monoklonsko protitelo.
English: It is used in patients whose disease has spread locally or to other parts of the body and who have previously been treated with other cancer medicines (chemotherapy).
Slovenian: Zdravilo Nivolumab BMS se uporablja pri bolnikih, pri katerih se je rak razširil lokalno ali na druge dele telesa, in pri bolnikih, ki so se predhodno zdravili z drugimi zdravili za zdravljenje raka (kemoterapija).
English: For the full list of all side effects and restrictions with Nivolumab BMS, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Nivolumab BMS glejte navodilo
English: For practical information about using Nivolumab BMS, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Nivolumab BMS naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The recommended dose is 3 mg of nivolumab per kilogram body weight given into a vein over 60 minutes, every two weeks for as long as the patient continues to benefit from it. Doses may need to be delayed or treatment stopped altogether if the patient develops certain severe side effects.
Slovenian: Priporočeni odmerek je 3 mg nivolumaba na kilogram telesne mase, ki se v 60 minutah vsaka dva tedna injicira v veno, dokler zdravljenje bolniku koristi.
English: What is Nivolumab BMS and what is it used for?
Slovenian: Kaj je zdravilo Nivolumab BMS in za kaj se uporablja?
English: The antigen to which nivolumab has been designed to attach is a receptor called ‘programmed cell death-1' (PD-1), which switches off the activity of certain cells of the immune system (the body's natural defences) called T cells.
Slovenian: Antigen, za vezavo na katerega je bil izdelan nivolumab, je receptor, imenovan „programirana celična smrt-1“ (PD-1), ki izklopi dejavnost nekaterih celic imunskega sistema (naravne obrambe telesa), imenovanih celice T. Ko se nivolumab veže na PD-1, zavira ta receptor in mu prepreči izklop celic imunskega sistema.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Nivolumab BMS, 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: It is not intended to provide practical advice on how to use Nivolumab BMS.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: What benefits of Nivolumab BMS have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Nivolumab BMS izkazalo v študijah?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nivolumab BMS on 20.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Nivolumab BMS, veljavno po vsej Evropski uniji,
English: What are the risks associated with Nivolumab BMS?
Slovenian: Kakšna tveganja so povezana z zdravilom Nivolumab BMS?
English: Most will resolve following appropriate treatment or on stopping Nivolumab BMS.
Slovenian: Večina učinkov izzveni po ustreznem zdravljenju ali prekinitvi uporabe
English: Side effects were considered manageable with appropriate measures and were outweighed by the benefits.
Slovenian: Koristi zdravljenja odtehtajo neželene učinke, ki ob ustreznih ukrepih veljajo za obvladljive.
English: The medicine was associated with improved survival over docetaxel in patients with advanced, previously treated squamous NSCLC, a patient group who have few treatment options.
Slovenian: Zdravilo je bilo v primerjavi z docetakselom povezano z izboljšanim preživetjem bolnikov z napredovalim, predhodno zdravljenim ploščatoceličnim nedrobnoceličnim pljučnim rakom, tj. skupino bolnikov, za katero je na voljo malo možnosti zdravljenja.
English: Nivolumab BMS can only be obtained with a prescription and treatment must be started and supervised by a doctor experienced in the treatment of cancer.
Slovenian: Izdaja zdravila Nivolumab BMS je le na recept, zdravljenje pa mora začeti in nadzorovati zdravnik, ki
English: Why is Nivolumab BMS approved?
Slovenian: Zakaj je bilo zdravilo Nivolumab BMS odobreno?
English: The medicine contains the active substance nivolumab.
Slovenian: Zdravilo Nivolumab BMS vsebuje zdravilno učinkovino nivolumab.
English: How is Nivolumab BMS used?
Slovenian: Kako se zdravilo Nivolumab BMS uporablja?
English: Nivolumab BMS have been shown to improve patients' survival in one main study involving 272 patients with previously treated squamous NSCLC that was advanced or had spread throughout the body.
Slovenian: V eni glavni študiji, ki je vključevala 272 bolnikov s predhodno zdravljenim ploščatoceličnim nedrobnoceličnim pljučnim karcinomom, ki je napredoval ali se razširil po telesu, so dokazali, da je zdravilo Nivolumab BMS izboljšalo preživetje bolnikov.
English: How does Nivolumab BMS work?
Slovenian: Kako zdravilo Nivolumab BMS deluje?
English: In addition, the company that markets Nivolumab BMS will provide educational packs for doctors who are expected to prescribe the medicine, containing information on how it should be used and how to manage side effects, particularly side effects related to the activity of the immune system.
Slovenian: Ti kompleti bodo vsebovali informacije o načinu uporabe zdravila in obvladovanju neželenih učinkov, predvsem neželenih učinkov, povezanih z dejavnostjo imunskega sistema.
English: Intravenous use Vial (glass) 15 ml (20 mg/ml) 1 vial
Slovenian: 15 ml (20 mg/ml) 1 viala
English: 300mg Concentrate for solution for infusion
Slovenian: 300 mg Koncentrat za pripravo raztopine za infundiranje
English: (Invented) name Strength Pharmaceutical form
Slovenian: Številka postopka EMA (Izmišljeno) ime Jakost Farmacevtska oblika
English: This is the indication currently proposed by the applicant and has been registered in 15 member states of the EU.
Slovenian: To je indikacija, ki jo trenutno predlaga predlagatelj in je bila registrirana v 15 državah članicah EU.
English: You may need urgent medical attention or hospitalisation.
Slovenian: Lahko da potrebujete nujno zdravniško pomoč ali zdravljeje v bolnišnici.
English: Therefore the CHMP considered that this indication is acceptable.
Slovenian: Zato je bil CHMP mnenja, da je ta indikacija sprejemljiva.
English: Use in children and adolescents (< 18 years)
Slovenian: Uporaba pri otrocih in mladostnikih (< 18 let)
English: High Blood Pressure
Slovenian: Visok krvni tlak
English: 1407 Sofia
Slovenian: 1407 Sofija
English: Clinical and biological monitoring is required.
Slovenian: Potrebno je spremljanje kliničnih in bioloških parametrov.
English: Most older patients require the same dose as younger patients.
Slovenian: Večina starejših bolnikov potrebuje enak odmerek kot mlajši bolniki.
English: At least 61 percent of the oral dose is eliminated unchanged within 24 hours.
Slovenian: Vsaj 61 % peroralnega odmerka se izloči nespremenjenega v 24 urah.
English: This effect is thought to be a result of the complimentary actions of both components.
Slovenian: Domnevajo, da je ta učinek posledica komplementarnega delovanja obeh učinkovin.
English: The clinical consequences of these interactions have not been evaluated.
Slovenian: Klinični pomen teh interakcij ni bil ovrednoten.
English: The volume of distribution of losartan is 34 liters.
Slovenian: Volumen porazdelitve losartana je 34 litrov.
English: • if you are, think you may be or are planning to become pregnant (see also “Pregnancy and breast-feeding”)
Slovenian: • če ste noseči, mislite, da ste noseči, ali če nameravate zanositi (glejte tudi poglavje "Nosečnost in dojenje").
English: Consequently, there is thus no increase in bradykinin-mediated undesirable effects.
Slovenian: Posledično ne potencira z bradikininom povezanih neželenih učinkov.
English: This is a serious but rare side effect, which affects more than 1 out of 10,000 patients but fewer than 1 out of 1,000 patients.
Slovenian: To je resen vendar redek neželeni učinek, ki prizadane več kot 1 od 10.000 bolnikov, vendar manj kot 1 od 1.000 bolnikov.
English: There is no experience in children and adolescents.
Slovenian: Izkušenj pri otrocih in mladostnikih ni.
English: LIFE Study
Slovenian: Študija LIFE
English: When you begin treatment with this medication, you should not perform tasks which may require special attention (for example, driving an automobile or operating dangerous machinery) until you know how you tolerate your medicine.
Slovenian: Na začetku zdravljenja s tem zdravilom ne opravljajte opravil, ki zahtevajo posebno pozornost (na primer vožnje avtomobila ali upravljanje nevarnih strojev) dokler ne veste, kako zdravilo prenašate.
English: 75114 Paris Cedex 08 France
Slovenian: 75114 Paris Cedex 08 Francija
English: LABORATÓRIO MEDINFAR, Produtos Farmacêuticos, SA Rua Manuel Ribeiro de Pavia, 1-1° Venda Nova
Slovenian: Portugalska LABORATÓRIO MEDINFAR, Produtos Farmacêuticos, SA Rua Manuel Ribeiro de Pavia, 1-1° Venda Nova
English: Dosage adjustment of the antidiabetic drug may be required.
Slovenian: Lahko je potrebna prilagoditev odmerka antidiabetičnega zdravila.
English: However, if you miss a dose, do not take an extra dose.
Slovenian: Če izpustite odmerek, ne vzemite dvojnega odmerka.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF COZAAR COMP. AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA COZAAR COMP. IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
English: If symptomatic hypotension should occur, supportive treatment should be instituted.
Slovenian: Če bi se pojavila simptomatska hipotenzija, je potrebno podporno zdravljenje.
English: Skanstes street 13, LV-1013, Riga, Latvia
Slovenian: Skanstes street 13, LV-1013, Riga, Latvija
English: These patients (9.4%) would have been over-treated on a FDC on a long term basis.
Slovenian: Ti bolniki (9,4 %) bi bili v primeru dolgotrajnega zdravljenja s fiksno kombinacijo odmerkov prekomerno zdravljeni.
English: Germany VARIPHARM ARZNEIMITTEL GMBH
Slovenian: VARIPHARM ARZNEIMITTEL GMBH
English: In case of an overdose, contact your doctor immediately so that medical attention may be given promptly.
Slovenian: V primeru prevelikega odmerjanja, se takoj posvetujte z zdravnikom, da lahko takoj dobite ustrezno zdravniško pomoč.
English: You are advised not to drink alcohol whilst taking these tablets: alcohol and Cozaar Comp tablets may increase each other's effects.
Slovenian: Svetujemo vam, da med zdravljenjem s temi tabletami ne pijete alkohola: alkohol in zdravilo Cozaar Comp lahko povečata učinek drug drugega.
English: Given that the paediatric worksharing group is still ongoing, a definite working can only be implemented with respecto to studies in children and adolescents after the procedure is finalised.
Slovenian: Ker pediatrična delovna skupina še izvaja svoje delo, se lahko dokončna oblika dela glede študij pri otrocih in mladostnikih vnese šele po dokončanju postopka.
English: This medicinal product is authorized in the Member States of the EEA under the following names:
Slovenian: To zdravilo je v državah članicah EGP odobreno pod naslednjimi imeni: Avstrija
English: Frosst Portuguesa - Produtos Farmacêuticos, Lda.
Slovenian: Portugalska Frosst Portuguesa - Produtos Farmacêuticos, Lda.
English: Heptafarma- Companhia Farmacêutica, Sociedade Unipessoal, Lda
Slovenian: Portugalska Heptafarma- Companhia Farmacêutica, Sociedade Unipessoal, Lda
English: - the CHMP concluded that the Marketing Authorisation could be harmonised on the following indication:
Slovenian: - je CHMP zaključil, da je mogoče dovoljenje za promet z zdravilom uskladiti za naslednjo indikacijo:
English: Tatoiou Street, Nea Erythraia 14671, Greece
Slovenian: Tatoiou Street, Nea Erythraia 14671, Grčija
English: Electrolyte imbalances
Slovenian: Elektrolitska neravnovesja
English: - The Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee.
Slovenian: - so bili povzetki glavnih značilnosti zdravila, označevanje in navodila za uporabo, ki so jih predlagali imetniki dovoljenja za promet z zdravilom, ovrednoteni na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora,
English: It may harm them, even if their symptoms are the same as yours.
Slovenian: • škodovalo, čeprav imajo znake bolezni, podobne vašim.
English: • if you take diuretics (water pills)
Slovenian: • če jemljete diuretike (tablete za odvajanje vode).
English: Your doctor will decide on the appropriate dose of Cozaar Comp depending on your condition and whether you are taking other medicines.
Slovenian: Zdravnik vam bo predpisal ustrezen odmerek zdravila Cozaar Comp glede na vaše stanje in glede na to, ali jemljete še katera druga zdravila.
English: 28027 MADRID
Slovenian: 28027 MADRID, Španija
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned products (and its associated names), Denmark notified the CHMP/EMEA Secretariat of an official referral under Article 30 of Directive 2001/83/EC as amended in order to resolve divergences amongst the nationally authorised SPCs and thus to harmonise its divergent SPCs across the EU.
Slovenian: Zaradi razhajajočih se odločitev na državni ravni, ki so jih sprejele države članice glede odobritve zgoraj navedenih zdravil (in z njimi povezanih imen), je Danska obvestila sekretariat CHMP/EMEA o uradnem napotitvenem postopku v skladu s členom 30 Direktive 2001/83/ES, kakor je bila spremenjena, da bi tako razrešila razhajanja med državno odobrenimi povzetki glavnih značilnosti zdravila in s tem uskladila razhajajoče se povzetke glavnih značilnosti zdravila po vsej EU.
English: 00191 Rome, Italy
Slovenian: 00191 Rim, Italija
English: - the CHMP concluded that the data are not supportive of the following indications and therefore they should be removed from the marketing authorisation:
Slovenian: - je CHMP zaključil, da podatki ne podpirajo naslednjih indikacij, ki jih je treba zaradi tega umakniti:
English: Patients with a history of angiooedema (swelling of the face, lips, throat, and/or tongue) should be closely monitored (see section 4.8).
Slovenian: Bolnike, ki so kdaj imeli angioedem (otekanje obraza, ustnic, žrela in/ali jezika) je treba pozorno spremljati (glejte poglavje 4.8).
English: Rare (more than 1 out of 10000 patients and less than 1 out of 1000 patients) • Hepatitis (inflammation of the liver), abnormal liver function tests
Slovenian: Redki (pojavijo se pri več kot 1 od 10.000 ter manj kot 1 od 1.000 bolnikov): • hepatitis (vnetje jeter), nenormalni izvidi delovanja jeter
English: The CHMP considered that the text concerning pregnancy and lactation in the SPC (sections 4.3, 4.4 and 4.6) should be amended to include the outcome of the PhVWP report on ACE Inhibitors and angiotensin II receptors antagonists (AIIRAs) and recommendations on the use during the first trimester of pregnancy (EMEA/CHMP/PhVWP/474692/2007).
Slovenian: CHMP je menil, da je treba besedilo glede nosečnosti in dojenja v povzetku glavnih značilnosti zdravila (poglavja 4.3, 4.4 in 4.6) spremeniti, tako da bodo vključevala rezultate poročila PhVWP o zaviralcih ACE in antagonistih receptorjev za angiotenzin II (AIIRA-ji) ter priporočila o uporabi v prvem tromesečju nosečnosti (EMEA/CHMP/PhVWP/474692/2007).