FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a summary of the European public assessment report (EPAR) for Cotellic.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Cotellic.
English: The full EPAR and risk management plan summary for Cotellic 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 Cotellic sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Cotellic
Slovenian: Druge informacije o zdravilu Cotellic
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Cotellic'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 Cotellic večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Cotellic cobimetinib
Slovenian: Cotellic kobimetinib
English: It is given at a recommended dose of 60 mg a day (3 tablets of 20 mg).
Slovenian: Priporočeni odmerek zdravila je 60 mg na dan (tri tablete po 20 mg).
English: Treatment with Cotellic is given in 28 day cycles: the tablets are taken for 21 consecutive days, followed by a 7-day break.
Slovenian: Zdravljenje z zdravilom Cotellic poteka v ciklusih, ki trajajo 28 dni: tablete se jemljejo 21 zaporednih dni, nato pa sledi sedemdnevni premor.
English: A risk management plan has been developed to ensure that Cotellic is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Cotellic je bil pripravljen načrt obvladovanja tveganj.
English: Treatment with Cotellic must be started and supervised by a doctor experienced in the use of cancer medicines.
Slovenian: Zdravljenje z zdravilom Cotellic mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: It is not intended to provide practical advice on how to use Cotellic.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The most common side effects with Cotellic (which may affect more than 1 in 5 people) are diarrhoea, rash, nausea (feeling sick), vomiting, pyrexia (fever), photosensitivity (light sensitivity) reaction, abnormal results for certain liver function tests (increased levels of alanine aminotransferase, aspartate aminotransferase) and abnormal results for an enzyme related to muscle breakdown (creatine phosphokinase).
Slovenian: Najpogostejši neželeni učinki zdravila Cotellic (ki lahko prizadenejo več kot 1 osebo od 5) so driska, izpuščaji, navzeja (slabost), bruhanje, pireksija (povišana telesna temperatura), fotosenzibilnostna reakcija (občutljivost na svetlobo), nenormalni rezultati določenih preiskav delovanja jeter (povečane ravni alanin-aminotransferaze in aspartat-aminotransferaze) ter nenormalni rezultati za encim, ki je povezan z razgradnjo mišic (kreatin-fosfokinazo).
English: What benefits of Cotellic have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Cotellic izkazalo v študijah?
English: What are the risks associated with Cotellic?
Slovenian: Kakšna tveganja so povezana z zdravilom Cotellic?
English: Cotellic is available as tablets (20 mg).
Slovenian: Zdravilo Cotellic je na voljo v obliki tablet (20 mg).
English: What is Cotellic and what is it used for?
Slovenian: Kaj je zdravilo Cotellic in za kaj se uporablja?
English: Cotellic is a cancer medicine used to treat adults with melanoma (a type of skin cancer) that has spread to other parts of the body or cannot be surgically removed.
Slovenian: Cotellic je zdravilo proti raku, ki se uporablja za zdravljenje odraslih z melanomom (vrsto kožnega raka), ki se je razširil na druge dele telesa ali ga ni mogoče kirurško odstraniti.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cotellic, 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: For the full list of all side effects and restrictions reported with Cotellic, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev, o katerih so poročali pri uporabi zdravila Cotellic, glejte navodilo za uporabo.
English: In this study, adding Cotellic to vemurafenib was more effective than adding placebo to vemurafenib: it took on average 12.3 months before the disease got worse in patients given Cotellic, compared with 7.2 months in patients given placebo.
Slovenian: V tej študiji je bilo dodajanje zdravila Cotellic vemurafenibu učinkovitejše od dodajanja placeba vemurafenibu: v povprečju je pri bolnikih, ki so prejemali zdravilo Cotellic, do poslabšanja bolezni preteklo 12,3 meseca, medtem ko je pri bolnikih, ki so prejemali placebo, to obdobje trajalo 7,2 meseca.
English: Although a supportive study showed that patients who were not previously treated with BRAF or MEK inhibitor medicines (such as vemurafenib) seemed to benefit the most from the therapy, the Committee considered that patients who previously received BRAF inhibitors may still benefit from treatment with Cotellic and vemurafenib.
Slovenian: Čeprav je podporna študija pokazala, da je zdravljenje najbolj koristilo bolnikom, ki pred tem niso bili zdravljeni z zaviralci BRAF ali MEK (kot je vemurafenib), je Odbor menil, da lahko zdravljenje z zdravilom Cotellic in vemurafenibom koristi tudi bolnikom, ki so že prejemali zaviralce BRAF.
English: Why is Cotellic approved?
Slovenian: Zakaj je bilo zdravilo Cotellic odobreno?
English: The doctor may need to interrupt or stop treatment, or reduce the dose, if the patient experiences certain side effects.Treatment should continue for as long as the disease improves or remains stable and side effects are tolerable.
Slovenian: Če se pri bolniku pojavijo nekateri neželeni učinki, bo zdravnik morda moral začasno ali trajno prekiniti zdravljenje oziroma zmanjšati odmerek.Zdravljenje je treba nadaljevati, dokler se bolezen izboljšuje oziroma ostaja stabilna, neželeni učinki pa so znosni.
English: For more information about treatment with Cotellic, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Cotellic preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: For practical information about using Cotellic, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Cotellic naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: This encourages the cancer to develop by allowing uncontrolled division of the cancer cells.
Slovenian: To omogoči nenadzorovano delitev celic in tako spodbudi nastanek raka.
English: Because Cotellic and vemurafenib work by blocking different proteins important for cancer growth, combining them results in a better response and could delay cancer cells becoming resistant to vemurafenib.
Slovenian: Ker zdravilo Cotellic in vemurafenib delujeta tako, da zavirata različne beljakovine, ki so pomembne za rast raka, omogoča kombiniranje obeh zdravil boljši odziv in lahko podaljša čas, dokler rakave celice ne postanejo odporne proti vemurafenibu.
English: Cotellic is used in combination with another medicine called vemurafenib.
Slovenian: Zdravilo Cotellic se uporablja v kombinaciji z drugim zdravilom, imenovanim vemurafenib.
English: Before starting treatment, patients must be tested for the BRAF V600 mutation.
Slovenian: Pred uvedbo zdravljenja morajo bolniki opraviti preiskavo, s katero se ugotavlja mutacija BRAF V600.
English: In melanoma with the BRAF V600 mutation, an abnormal form of the protein BRAF is produced, which switches on the protein MEK.
Slovenian: Pri melanomih z mutacijo BRAF V600 se tvori nenormalna oblika beljakovine BRAF, ki aktivira beljakovino MEK.
English: Cotellic is only given to patients whose melanoma is caused by the BRAF V600 mutation and must be used in combination with vemurafenib, which is a BRAF inhibitor.
Slovenian: Zdravilo Cotellic se daje le bolnikom, pri katerih je melanom povzročila mutacija BRAF V600, uporabljati pa se mora v kombinaciji z vemurafenibom, ki je zaviralec BRAF.
English: It is only for patients whose melanoma tumour cells have been shown to have a specific mutation (change) in the BRAF gene called ‘BRAF V600'.
Slovenian: Primerno je samo za bolnike, pri katerih je pri celicah melanoma dokazano prišlo do mutacije (spremembe) gena BRAF, imenovane BRAF V600.
English: Cotellic works by blocking MEK directly and by preventing its activation by the abnormal form of BRAF, thereby slowing down the growth and spread of the cancer.
Slovenian: Zdravilo Cotellic deluje tako, da neposredno zavira beljakovino MEK ter nenormalni obliki beljakovine BRAF preprečuje, da bi aktivirala beljakovino MEK, s čimer upočasni rast in širjenje raka.
English: Cotellic has been studied in one main study involving 495 patients with melanoma that had spread or that could not be surgically removed, and whose melanoma had a BRAF V600 mutation.
Slovenian: Zdravilo Cotellic so proučevali v eni glavni študiji, v katero je bilo vključenih 495 bolnikov z melanomom z mutacijo BRAF V600, ki se je razširil oziroma ga ni bilo mogoče kirurško odstraniti.
English: The active substance in Cotellic, cobimetinib, is an inhibitor of MEK, a protein involved in stimulating normal cell division.
Slovenian: Zdravilna učinkovina zdravila Cotellic, kobimetinib, je zaviralec beljakovine MEK, ki sodeluje pri spodbujanju normalne delitve celic.
English: How is Cotellic used?
Slovenian: Kako se zdravilo Cotellic uporablja?
English: How does Cotellic work?
Slovenian: Kako zdravilo Cotellic deluje?
English: The Committee noted that Cotellic in combination with vemurafenib had shown a clinically relevant benefit in patients whose melanoma had a BRAF V600 mutation, when compared with vemurafenib alone.
Slovenian: Menil je, da je zdravilo Cotellic v kombinaciji z vemurafenibom v primerjavi s samim vemurafenibom izkazalo klinično pomembne koristi za bolnike z melanomom z mutacijo BRAF V600.
English: Cotellic contains the active substance cobimetinib.
Slovenian: Zdravilo Cotellic vsebuje zdravilno učinkovino kobimetinib.
English: Patients had not been previously treated and were given either Cotellic with vemurafenib or placebo (a dummy treatment) with vemurafenib; the main measure of effectiveness was how long patients lived without their disease getting worse (progression-free survival).
Slovenian: Med študijo so prejemali bodisi zdravilo Cotellic skupaj z vemurafenibom bodisi placebo (zdravilo brez zdravilne učinkovine) skupaj z vemurafenibom.
English: Adopted at the 4-7 May 2015 PRAC
Slovenian: Sprejeto na seji odbora PRAC med 4. in 7. majem 2015
English: Section 4:
Slovenian: Poglavje 4:
English: Some side effects could be or could become serious
Slovenian: Nekateri neželeni učinki so lahko resni oziroma lahko postanejo resni
English: PRAC recommendations on signals for update of product information
Slovenian: Priporočila odbora PRAC o signalih za posodobitev informacij o zdravilu
English: You may need your treatment to be reviewed to ensure you keep receiving appropriate treatment for your condition.
Slovenian: Morda bo treba ponovno oceniti vaše zdravljenje, da boste še naprej prejemali ustrezno zdravljenje za svojo bolezen.
English: Section 2: What you need to know before you take Arava Warning and precautions
Slovenian: Poglavje 2: Kaj morate vedeti, preden boste vzeli zdravilo Arava Opozorila in previdnostni ukrepi
English: A targeted questionnaire should be implemented to maximise the information obtained from future cases.
Slovenian: Prav tako je treba uvesti ciljno usmerjen vprašalnik, da bi pridobili čim več informacij o prihodnjih primerih.
English: The frequency may be calculated by considering the frequency of anaemia and haemolytic anaemia in studies.
Slovenian: Pogostnost se lahko izračuna ob upoštevanju pogostnosti anemije in hemolitične anemije v študijah.
English: PML is an opportunistic infection caused by JohnCunningham virus (JCV) which may be fatal or result in severe disability.
Slovenian: PML je oportunistična okužba, ki jo povzroča virus John-Cunningham (JCV) in je lahko smrtna ali povzroči hudo invalidnost.
English: Section 4.4 - Special warning and precautions for use:
Slovenian: Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi:
English: Symptoms may include new or worsening weakness on one side of the body: clumsiness, changes in vision, speech, thinking, or memory; or confusion or personality changes lasting for more than several days.
Slovenian: Med simptomi so lahko prvi pojav ali poslabšanje šibkosti na eni strani telesa: nerodnost, spremembe vida, govora, razmišljanja ali spomina, ali zmedenost ali spremembe osebnosti, ki trajajo več kot nekaj dni.
English: If you experience eye irritation severe enough to make your eyes water excessively, or make you consider stopping this medicine, talk to your doctor, pharmacist or nurse promptly (within a week).
Slovenian: Če se pojavi draženje očesa, ki je tako hudo, da se vam oči čezmerno solzijo ali da razmišljate o tem, da bi prenehali uporabljati to zdravilo, se čim prej (v enem tednu) posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Frequency ‘common': colitis
Slovenian: Pogostnost „pogosti“: kolitis
English: Summary of Product Characteristics (SmPC): Section 4.4 - Special warnings and precautions for use Infections
Slovenian: Povzetek glavnih značilnosti zdravila: Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi Okužbe
English: Latanoprost (Xalatan) - Increased reporting of eye disorders, in particular eye irritation, after change of formulation (EPITT no 18068)
Slovenian: Latanoprost (Xalatan) - povečano število poročil o očesnih boleznih, zlasti o draženju oči, po zamenjavi formulacije (EPITT št. 18068)
English: • Eye irritation (a feeling of burning, grittiness, itching, stinging or the sensation of a foreign body in the eye).
Slovenian: • Draženje oči (pekoč, praskajoč občutek, srbenje, zbadanje in občutek tujka).
English: In case of PML is suspected, treatment with fingolimod should be discontinued.
Slovenian: Če obstaja sum, da se je razvila PML, je treba zdravljenje s fingolimodom prekiniti.
English: The PRAC agreed to ask for a scientific advisory group (SAG) advice regarding the risk factors and the monitoring (e.g. MRI, JCV status, CD4+/CD8+ ratio) of the patients treated with fingolimod, in order to advise on possibilities to improve the prognosis of the patients diagnosed early, and to identify patients at risk of developing PML.
Slovenian: Odbor PRAC se je strinjal, da znanstveno svetovalno skupino zaprosi za mnenje v zvezi z dejavniki tveganja in spremljanjem (npr. MRS, prisotnost virusa JC, razmerje celic CD4+ in CD8+) bolnikov, ki se zdravijo s fingolimodom, da bi se posvetovali o možnostih za izboljšanje prognoze bolnikov ob zgodnji diagnozi in prepoznavanje bolnikov, pri katerih obstaja tveganje za pojav PML.
English: Fingolimod - Progressive Multifocal Leukoencephalopathy (PML) (EPITT no 18241)
Slovenian: Fingolimod - progresivna multifokalna levkoencefalopatija (PML) (EPITT št. 18241)
English: Leflunomide - Colitis (EPITT no 18189)
Slovenian: Leflunomid - kolitis (EPITT št. 18189)
English: Natalizumab - Anaemia (EPITT no 18137)
Slovenian: Natalizumab - anemija (EPITT št. 18137)
English: The symptoms of PML may be similar to an MS relapse.
Slovenian: Simptomi PML so lahko podobni kot pri napadu multiple skleroze.
English: Frequency “not known”: Progressive multifocal leukoencephalopathy (PML) Package Leaflet:
Slovenian: Pogostost „neznana“: progresivna multifokalna levkoencefalopatija (PML) Navodilo za uporabo:
English: Having considered the available evidence, including data submitted by the Marketing Authorisation Holder (MAH), and taking into account that Progressive Multifocal Leukoencephalopathy (PML) is a complex disease which may take a prolonged time before becoming clinically symptomatic, the PRAC has agreed that an update of the product information is warranted.
Slovenian: Odbor PRAC se je po proučitvi razpoložljivih podatkov, med katerimi so bili tudi podatki, ki jih je predložil imetnik dovoljenja za promet z zdravilom, in ob upoštevanju dejstva, da je progresivna multifokalna levkoencefalopatija (PML) zapletena bolezen, pri kateri lahko preteče dalj časa, preden se pokažejo klinični simptomi, strinjal, da je potrebna posodobitev informacij o zdravilu.
English: Having considered the available evidence from spontaneous reports, EudraVigilance and the literature, the PRAC considers that patients receiving Xalatan should be warned about the importance of seeking medical advice if they experience excessive eye irritation.
Slovenian: Odbor PRAC je po proučitvi razpoložljivih podatkov iz spontanih poročil, podatkovne zbirke EudraVigilance in literature menil, da je treba bolnike, ki prejemajo zdravilo Xalatan, opozoriti na to, da je pomembno, da ob čezmernem draženju oči poiščejo zdravniško pomoč.
English: Frequency ‘common': Colitis including microscopic colitis such as lymphocytic colitis, collagenous colitis.
Slovenian: Pogostnost „pogosti“: kolitis, vključno z mikroskopskim kolitisom, kot je na primer limfocitni kolitis ali kolagenski kolitis.
English: Furthermore, the MAH should continue to monitor events of eye irritation and present updated data in the next PSUR.
Slovenian: Poleg tega mora imetnik dovoljenja za promet z zdravilom še naprej spremljati dogodke, povezane z draženjem oči, in v naslednjem redno posodobljenem poročilu o varnosti zdravila predstaviti posodobljene podatke.
English: Therefore the MAH for Xalatan (latanoprost) should submit a variation within 2 months to update the Package Leaflet as described below (new text underlined).
Slovenian: Imetnik dovoljenja za promet z zdravilom Xalatan (latanoprost) mora zato v dveh mesecih predložiti vlogo za posodobitev navodila za uporabo, kot je opisano spodaj (novo besedilo je podčrtano).
English: Therefore, the MAH for fingolimod should submit a variation within 2 months, to amend the product information as described below (new text underlined) and to include PML in the RMP as an important identified risk (under the risk of infections).
Slovenian: Imetnik dovoljenja za promet s fingolimodom mora zato v dveh mesecih predložiti vlogo za spremembo informacij o zdravilu, kot je opisano spodaj (novo besedilo je podčrtano), in za vključitev progresivne multifokalne levkoencefalopatije kot pomembnega znanega tveganja v načrt obvladovanja tveganj (pod tveganje za okužbe).
English: Having considered the data submitted by the MAH, as well as the evidence from EudraVigilance cases and the literature, the MAH of Tysabri should submit a variation within 60 days to add “anaemia” and “haemolytic anaemia” to section 4.8 of the SmPC and to update the Package Leaflet accordingly.
Slovenian: Na podlagi proučitve podatkov, ki jih je predložil imetnik dovoljenja za promet z zdravilom, ter podatkov iz podatkovne zbirke EudraVigilance in literature mora imetnik dovoljenja za promet z zdravilom Tysabri v 60 dneh predložiti vlogo za spremembo, da se v poglavje 4.8 povzetka glavnih značilnosti zdravila dodata „anemija“ in „hemolitična anemija“ ter ustrezno posodobi navodilo za uporabo.
English: Having considered the available evidence from clinical trials (colitis reported in 1% to <3% in treatment arm), from spontaneous cases including reported positive de-challenge and re-challenge cases as well as supporting reports in literature, the PRAC has agreed that the MAH(s) of leflunomidecontaining products should submit a variation within 2 months, to amend the product information as described below (new text underlined).
Slovenian: Odbor PRAC se je po proučitvi razpoložljivih podatkov iz kliničnih preskušanj (o kolitisu so poročali pri 1 % do < 3 % oseb v skupini, ki je prejemala zdravilo), spontanih poročil, med katerimi so bila tudi poročila o primerih izboljšanja po prenehanju uporabe zdravila in poslabšanja po ponovni uporabi, ter dodatnih poročil iz literature strinjal, da mora(jo) imetnik(i) dovoljenja za promet z zdravili, ki vsebujejo leflunomid, v dveh mesecih predložiti vlogo za spremembo informacij o zdravilu, kot je opisano spodaj (novo besedilo je podčrtano).
English: The prescriber's guide should be updated with this risk and PML should also be closely monitored in future PSURs.
Slovenian: Prav tako je treba to tveganje dodati v navodila za predpisovanje in skrbno spremljati PML v prihodnjih redno posodobljenih poročilih o varnosti zdravila.
English: Progressive multifocal leukoencephalopathy (PML) has been reported under fingolimod treatment since marketing authorization (see section 4.8).
Slovenian: Po izdaji dovoljenja za promet z zdravilom so pri zdravljenju s fingolimodom poročali o progresivni multifokalni levkoencefalopatiji (PML) (glejte poglavje 4.8).
English: During routine MRI, physicians should pay attention to PML suggestive lesions.
Slovenian: Zdravniki morajo biti med rednim magnetno resonančnim slikanjem pozorni na lezije, ki bi lahko bile znak PML.
English: Not known (frequency cannot be estimated from the available data) Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML).
Slovenian: Tveganje za redko okužbo možganov, imenovano progresivna multifokalna levkoencefalopatija (PML).
English: Package Leaflet:
Slovenian: Navodilo za uporabo:
English: This overview was last updated in 07-2019.
Slovenian: Povzetek je bil nazadnje posodobljen 07-2019.
English: Symtuza received a marketing authorisation valid throughout the EU on 21 September 2017.
Slovenian: Za zdravilo Symtuza je bilo 21. septembra 2017 izdano dovoljenje za promet, veljavno po vsej EU.
English: Other information about Symtuza
Slovenian: Druge informacije o zdravilu Symtuza
English: Overall, 75% of patients taking Symtuza (77 patients out of 103) achieved this reduction after 24 weeks of treatment, which was similar to the 74% (37 of 50) of patients who achieved it with the comparator.
Slovenian: Skupno je do takšnega zmanjšanja po 24 tednih zdravljenja prišlo pri 75 % (77 od 103) bolnikov, ki so jemali zdravilo Symtuza , kar je bilo primerljivo s 74 % (37 od 50) bolnikov, ki so to dosegli s primerjalnim zdravilom.
English: What measures are being taken to ensure the safe and effective use of Symtuza?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Symtuza?
English: Further information on Symtuza can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/symtuza.
Slovenian: Nadaljnje informacije o zdravilu Symtuza so na voljo na spletni strani agencije: ema.europa.eu/en/medicines/human/EPAR/symtuza.
English: The European Medicines Agency decided that Symtuza's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Symtuza večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: HIV-1 is a virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: HIV-1 je virus, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: It must also not be taken with certain medicines that can reduce the effectiveness of Symtuza, as well as medicines that can increase the risk of serious side effects.
Slovenian: Prav tako se ne sme jemati skupaj z nekaterimi zdravili, ki lahko zmanjšajo njegovo učinkovitost, in zdravili, ki lahko povečajo tveganje za resne neželene učinke.
English: Why is Symtuza authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Symtuza odobreno v EU?
English: What benefits of Symtuza have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Symtuza izkazalo v študijah?