FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, dosing should be adjusted according to their renal hepatic status (see section 4.2 and 4.4).
Slovenian: Razpoložljivi podatki pri starejših bolnikih so omejeni, zato je treba odmerjanje prilagoditi glede na stanje ledvic in jeter (glejte poglavji 4.2 in 4.4).
English: Medicinal products affecting pitolisant metabolism
Slovenian: Farmakokinetične interakcije Zdravila, ki vplivajo na presnovo pitolizanta
English: Agitation Hallucination Hallucination visual, auditory Affect lability Abnormal dreams Dyssomnia Middle insomnia Initial insomnia Terminal insomnia Nervousness Tension Apathy Nightmare Restlessness Panic Attack Libido decreased Libido increased
Slovenian: Psihiatrične motnje nespečnost tesnoba razdražljivost depresija motnje spanja agitacija halucinacije vizualne, slušne halucinacije čustvena labilnost nenormalne sanje disomnija prebujanje ponoči težave pri uspavanju zgodnje prebujanje živčnost napetost apatija nočne more nemir panični napad zmanjšan libido povečan libido nenormalno vedenje stanje zmedenosti depresivno razpoloženje razdražljivost obsesivne misli disforija hipnopompne halucinacije depresivni simptomi hipnagogne halucinacije motnje umskih sposobnosti
English: General physical condition abnormal Electrocardiogram repolarisation abnormality Electrocardiogram T wave inversion
Slovenian: Preiskave povečanje telesne mase zmanjšanje telesne mase povišana raven jetrnih encimov povišana raven kreatinfosfokinaze podaljšan interval QT na elektrokardiogramu povišan srčni utrip povišana raven gamaglutamiltransferaze nenormalno splošno telesno stanje abnormalnost repolarizacije na elektrokardiogramu inverzija vala T na elektrokardiogramu
English: Each film-coated tablet of Wakix 4.5 mg contains 5 mg of pitolisant hydrochloride, equivalent to 4.45 mg of pitolisant.
Slovenian: Ena filmsko obložena tableta zdravila Wakix 4,5 mg vsebuje 5 mg pitolizantijevega klorida, kar je enako 4,45 mg pitolizanta.
English: Wakix 4.5 mg film-coated tablets Wakix 18 mg film-coated tablets
Slovenian: Wakix 4,5 mg filmsko obložene tablete Wakix 18 mg filmsko obložene tablete
English: - Have severe liver problems, as pitolisant is normally broken down in the liver and excess levels may build up in patients whose liver function is severely reduced.
Slovenian: - če ste alergični na pitolizant ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če imate hude težave z jetri, saj se pitolizant običajno razgrajuje v jetrih in se pri bolnikih z močno zmanjšanim delovanjem jeter lahko začne kopičiti v čezmernih količinah; - če dojite.
English: Wakix 18 mg film-coated tablets Pitolisant
Slovenian: Wakix 18 mg filmsko obložene tablete pitolizant
English: Common side effects (may affect up to 1 in 10 people): - Difficulty in sleeping, feeling anxious, feeling irritable, feeling depressed, sleeping problems
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): - težave pri spanju, občutek tesnobe, občutek razdraženosti, občutek depresije, težave s spanjem, - glavobol, občutek „vrtenja“ (vrtoglavica), izguba ravnotežja, tresenje, - slabost s siljenjem na bruhanje, bruhanje, težave s prebavo, - utrujenost.
English: With St John's Wort (Hypericum Perforatum), due to its strong CYP3A4 inducing effect, caution should be exercised when taken concurrently with pitolisant.
Slovenian: Previdnost je potrebna tudi pri sočasni uporabi pitolizanta s šentjanževko (Hypericum perforatum), ki močno inducira CYP3A4.
English: Therefore, dosing should be adjusted according to their renal and hepatic status.
Slovenian: Razpoložljivi podatki pri starejših bolnikih so omejeni, zato je treba odmerjanje prilagoditi glede na stanje ledvic in jeter.
English: Wakix 18 mg comes in a white, round, film-coated tablet of 7.5 mm, biconvex marked with “20” on one side.
Slovenian: Zdravilo Wakix 18 mg je v obliki okrogle bikonveksne filmsko obložene tablete s premerom 7,5 mm in oznako „20“ na eni strani.
English: Wakix 4.5 mg comes in a white, round, film-coated tablet of 3.7 mm, biconvex marked with “5” on one side.
Slovenian: Zdravilo Wakix 4,5 mg je v obliki okrogle bikonveksne filmsko obložene tablete s premerom 3,7 mm in oznako „5“ na eni strani.
English: Do not take Wakix if you
Slovenian: Ne jemljite zdravila Wakix:
English: Wakix 4.5 mg film-coated tablet Each tablet contains 5 mg of pitolisant hydrochloride equivalent to 4.45 mg of pitolisant.
Slovenian: Wakix 4,5 mg filmsko obložene tablete Ena tableta vsebuje 5 mg pitolizantijevega klorida, kar ustreza 4,45 mg pitolizanta.
English: How to store Wakix
Slovenian: Shranjevanje zdravila Wakix
English: Wakix 4.5 mg film-coated tablets Wakix 18 mg film-coated tablets Pitolisant
Slovenian: Wakix 4,5 mg filmsko obložene tablete Wakix 18 mg filmsko obložene tablete pitolizant
English: Headache Dizziness Tremor
Slovenian: Okvara jeter
English: Drug-drug interactions
Slovenian: Medsebojno delovanje med zdravili
English: Wakix 4.5 mg film-coated tablets Pitolisant
Slovenian: Wakix 4,5 mg filmsko obložene tablete pitolizant
English: Wakix 18 mg tablet Each tablet contains 20 mg of pitolisant hydrochloride, equivalent to 17.8 mg of pitolisant.
Slovenian: Wakix 18 mg tableta Ena tableta vsebuje 20 mg pitolizantijevega klorida, kar ustreza 17,8 mg pitolizanta.
English: Rare side effects (may affect up to 1 in 1000 people): - Loss of appetite, increased appetite - Abnormal behaviour, confusional state, depressed mood, excitability, feelings of emotional and mental discomfort, feeling of seeing or hearing things that are not really there when you sleep - Loss of consciousness, tension headache, , trouble of the memory, poor sleep quality - Abdominal discomfort, difficulty or pain in swallowing, flatulence, inflammation of the digestive tract - Infection of the skin, abnormally high sensitivity to sunlight - Neck pain, chest pain - Spontaneous abortion - Pain, night sweats, sense of oppression
Slovenian: - nenormalno vedenje, stanje zmedenosti, depresivno razpoloženje, vzdražljivost, občutki čustvenega in duševnega nelagodja, občutek videnja ali slišanja stvari med spanjem, ki jih v resnici ni, - izguba zavesti, tenzijski glavobol, težave s spominom, slaba kakovost spanja, - nelagodje v trebuhu, težave ali bolečina pri požiranju, vetrovi, vnetje prebavil, - okužba kože, neobičajno velika občutljivost na sončno svetlobo, - bolečina v vratu, bolečina v prsnem košu, - spontani splav, - bolečina, nočno potenje, občutek pobitosti, - visoka raven encima kreatin-fosfokinaze v krvi, nenormalno splošno telesno stanje, sprememba pri električnem zaznavanju delovanja srca (EKG).
English: Each film-coated tablet of Wakix 18 mg contains 20 mg of pitolisant hydrochloride equivalent to 17.8 mg of pitolisant.
Slovenian: Ena filmsko obložena tableta zdravila Wakix 18 mg vsebuje 20 mg pitolizantijevega klorida, kar je enako 17,8 mg pitolizanta.
English: CYP2D6 poor metabolizers
Slovenian: Bolniki, ki slabo presnavljajo prek CYP2D6
English: Rebound effect
Slovenian: Povratni fenomen
English: White, round, biconvex film-coated tablet, 7.5 mm diameter marked with “20” on one side.
Slovenian: Wakix 18 mg filmsko obložene tablete bela okrogla bikonveksna filmsko obložena tableta s premerom 7,5 mm in oznako „20“ na eni strani
English: Wakix 18 mg film-coated tablet Each tablet contains 20 mg of pitolisant hydrochloride equivalent to 17.8 mg of pitolisant.
Slovenian: Wakix 18 mg filmsko obložene tablete Ena tableta vsebuje 20 mg pitolizantijevega klorida, kar je ustreza 17,8 mg pitolizanta.
English: - You have a gastric ulcer or you take medicines that can irritate your stomach such as medicines against inflammations, since gastric reactions have been reported with Wakix.
Slovenian: Kaj je zdravilo Wakix in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Wakix Kako jemati zdravilo Wakix Možni neželeni učinki
English: Microcrystalline cellulose Crospovidone type A Talc
Slovenian: 6.1 Seznam pomožnih snovi Jedro tablete mikrokristalna celuloza krospovidon tipa A smukec magnezijev stearat koloidni brezvodni silicijev dioksid
English: White, round, biconvex film-coated tablet, 3.7 mm diameter, marked with “5” on one side.
Slovenian: Wakix 4,5 mg filmsko obložene tablete bela okrogla bikonveksna filmsko obložena tableta s premerom 3,7 mm in oznako „5“ na eni strani
English: Asthenia Chest Pain Feeling Abnormal Malaise Oedema Peripheral oedema
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost astenija bolečina v prsnem košu nenormalno počutje splošno slabo počutje edem periferni edem bolečina nočno potenje občutek pobitosti
English: Nausea Vomiting Dyspepsia
Slovenian: Bolezni sečil polakisurija
English: Gastrooesophageal reflux disease Gastritis Gastrointestinal pain Hyperacidity Paraesthesia oral Stomach discomfort
Slovenian: Bolezni prebavil navzea bruhanje dispepsija suha usta bolečina v trebuhu driska neugodje v trebuhu bolečina v zgornjem delu trebuha zaprtost gastroezofagealna refluksna bolezen gastritis bolečina v prebavilih čezmerna želodčna kislina oralna parestezija neugodje v želodcu napihnjenost trebuha disfagija flatulenca odinofagija enterokolitis
English: - Are breastfeeding.
Slovenian: - Navodilo shranite.
English: Decreased appetite Increased appetite Fluid retention
Slovenian: Presnovne in prehranske motnje zmanjšan tek povečan tek zastajanje tekočine anoreksija hiperfagija motnje teka
English: Wakix 4.5 mg film-coated tablet
Slovenian: Wakix 4,5 mg tableta
English: Toxic skin eruption Photosensitivity
Slovenian: Bolezni kože in podkožja eritem srbenje izpuščaj hiperhidroza potenje toksični kožni izbruh občutljivost na svetlobo
English: Musculoskeletal and connective tissue disorders
Slovenian: Ušesne bolezni, vključno z motnjami labirinta vrtoglavica tinitus
English: The applicant presented data on experimental models from the scientific literature.
Slovenian: Predlagatelj je predstavil podatke o poskusnih modelih iz znanstvene literature.
English: It is available as white round tablets (10 and 20 mg).
Slovenian: Na voljo je v obliki belih, okroglih tablet (10 in 20 mg).
English: The recommended maintenance dose is 10 to 20 mg once a day in patients with rheumatoid arthritis, and 20 mg once a day in patients with psoriatic arthritis.
Slovenian: Priporočeni vzdrževalni odmerek znaša od 10 do 20 mg enkrat na dan pri bolnikih z revmatoidnim artritisom ter 20 mg enkrat na dan pri bolnikih s psoriatičnim artritisom.
English: The full EPAR for Leflunomide ratiopharm can be searched for 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) za zdravilo Leflunomide ratiopharm je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Leflunomide ratiopharm on 29 November 2010.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Leflunomide ratiopharm, veljavno po vsej Evropski uniji, izdala 29. novembra 2010.
English: This means that Leflunomide ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Arava.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Arava.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Leflunomide ratiopharm.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Leflunomide ratiopharm treatment starts with a ‘loading dose' of 100 mg once a day for three days, followed by a maintenance dose.
Slovenian: Zdravljenje z zdravilom Leflunomide ratiopharm se začne z „udarnim odmerkom“ 100 mg enkrat na dan tri dni zapored, čemur sledi jemanje vzdrževalnega odmerka.
English: This is a summary of the European public assessment report (EPAR) for Leflunomide ratiopharm.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Leflunomide ratiopharm.
English: For more information about treatment with Leflunomide ratiopharm, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Leflunomide ratiopharm preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The doctor should carry out blood tests to check the patient's liver, white blood cell counts and platelet counts before prescribing Leflunomide ratiopharm, and regularly during treatment.
Slovenian: Zdravnik mora opraviti krvne preiskave za pregled delovanja jeter, števila belih krvnih celic in krvnih ploščic, preden predpiše zdravilo Leflunomide ratiopharm in nato v rednih časovnih presledkih med zdravljenjem.
English: With fewer lymphocytes, there is less inflammation, helping to control the symptoms of arthritis.
Slovenian: Zaradi manjšega števila prisotnih limfocitov je manjše tudi vnetje, kar pomaga pri nadzoru simptomov artritisa.
English: Leflunomide ratiopharm is used to treat adults with active rheumatoid arthritis (an immune system disease causing inflammation of the joints) or active psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).
Slovenian: Zdravilo Leflunomide ratiopharm se uporablja za zdravljenje odraslih z aktivnim revmatoidnim artritisom (boleznijo imunskega sistema, ki povzroča vnetje sklepov) ali aktivnim psoriatičnim artritisom (boleznijo, ki povzroča nastajanje rdečih in luskinastih zaplat na koži ter vnetje sklepov).
English: Leflunomide does this by blocking an enzyme called ‘dihydroorotate dehydrogenase', which is necessary for the lymphocytes to multiply.
Slovenian: Leflunomid to doseže z zaviranjem encima, imenovanega „dihidroorotat-dehidrogenaza“, ki je potreben za razmnoževanje limfocitov.
English: Because Leflunomide ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Leflunomide ratiopharm generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Leflunomide ratiopharm treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis.
Slovenian: Zdravljenje z zdravilom Leflunomide ratiopharm mora uvesti in nadzorovati zdravnik specialist, ki ima izkušnje z zdravljenjem revmatoidnega artritisa in psoriatičnega artritisa.
English: It reduces inflammation by reducing the production of immune cells called ‘lymphocytes', which are responsible for inflammation.
Slovenian: Zdravilo zmanjšuje vnetje tako, da zmanjša tvorjenje imunskih celic, imenovanih „limfociti“, ki so vzrok za vnetje.
English: The CHMP concluded that, in accordance with EU requirements, Leflunomide ratiopharm has been shown to have comparable quality and to be bioequivalent to Arava.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Leflunomide ratiopharm primerljivo raven kakovosti kot zdravilo Arava ter da mu je biološko enakovredno.
English: Therefore, the CHMP's view was that, as for Arava, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi, tako kot pri zdravilu Arava, odtehtajo znana tveganja.
English: Leflunomide ratiopharm leflunomide
Slovenian: Leflunomide ratiopharm leflunomid
English: What are the benefits and risks of Leflunomide ratiopharm?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Leflunomide ratiopharm?
English: Because Leflunomide ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Arava.
Slovenian: Ker je zdravilo Leflunomide ratiopharm generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Arava.
English: Leflunomide ratiopharm is a ‘generic medicine'.
Slovenian: Leflunomide ratiopharm je „generično zdravilo“.
English: The Committee recommended that Leflunomide ratiopharm be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Leflunomide ratiopharm izda dovoljenje za promet.
English: Leflunomide ratiopharm is a medicine that contains the active substance leflunomide.
Slovenian: Leflunomide ratiopharm je zdravilo, ki vsebuje zdravilno učinkovino leflunomid.
English: Other information about Leflunomide ratiopharm
Slovenian: Druge informacije o zdravilu Leflunomide ratiopharm
English: The active substance in Leflunomide ratiopharm, leflunomide, is an immunosuppressant.
Slovenian: Zdravilna učinkovina zdravila Leflunomide ratiopharm, leflunomid, je zdravilo za zaviranje imunske odzivnosti.
English: Why has Leflunomide ratiopharm been approved?
Slovenian: Zakaj je bilo zdravilo Leflunomide ratiopharm odobreno?
English: How has Leflunomide ratiopharm been studied?
Slovenian: Kako je bilo zdravilo Leflunomide ratiopharm raziskano?
English: How is Leflunomide ratiopharm used?
Slovenian: Kako se zdravilo Leflunomide ratiopharm uporablja?
English: What is Leflunomide ratiopharm used for?
Slovenian: Za kaj se zdravilo Leflunomide ratiopharm uporablja?
English: What is Leflunomide ratiopharm?
Slovenian: Kaj je zdravilo Leflunomide ratiopharm?
English: How does Leflunomide ratiopharm work?
Slovenian: Kako zdravilo Leflunomide ratiopharm deluje?
English: The name of the medicine was changed to Adcirca on 21 October 2009.
Slovenian: Ime zdravila je bilo 21. oktobra 2009 spremenjeno v Adcirca.
English: What measures are being taken to ensure the safe and effective use of Adcirca?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Adcirca?
English: tadalafil
Slovenian: Adcirca tadalafil
English: What benefit has Adcirca shown during the studies?
Slovenian: Kakšne koristi je zdravilo Adcirca izkazalo med študijami?
English: Before treatment, the patients could walk an average of 343 metres in six minutes.
Slovenian: Pred zdravljenjem so bolniki v šestih minutah povprečno lahko prehodili 343 metrov.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom necessary depending on the patient's response.
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom potrebi lahko poveča glede na njihov odziv.
English: Previously known as Tadalafil Lilly.
Slovenian: Prej znano kot Tadalafil Lilly.
English: The full EPAR for Adcirca 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) za zdravilo Adcirca je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for Tadalafil Lilly on 1 October 2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Tadalafil Lilly, veljavno po vsej Evropski uniji, izdala 1. oktobra 2008.
English: Other information about Adcirca
Slovenian: Druge informacije o zdravilu Adcirca
English: Adcirca is taken as two tablets (40 mg) once a day, with or without food.
Slovenian: Zdravilo se jemlje v odmerku dveh tablet (40 mg) enkrat na dan s hrano ali brez nje.
English: The main measure of effectiveness was the change in exercise capacity (the ability to carry out physical activity) measured by the distance the patients could walk in six minutes after 16 weeks of treatment.
Slovenian: Glavno merilo učinkovitosti je bilo izboljšanje telesne zmogljivosti (sposobnosti opravljanja telesne dejavnosti), izmerjeno na podlagi razdalje, ki so jo bolniki lahko prehodili v šestih minutah po 16 tednih zdravljenja.
English: What is the risk associated with Adcirca?
Slovenian: Kakšna tveganja so povezana z zdravilom Adcirca?
English: The ‘class' reflects the seriousness of the disease: ‘class II' involves slight limitation of physical activity and ‘class III' involves marked limitation of physical activity.
Slovenian: Razred odraža resnost bolezni: razred II pomeni rahlo omejitev telesne zmogljivosti, razred III pa znatno omejitev telesne zmogljivosti.
English: Adcirca is used in patients with class II or III disease.
Slovenian: Zdravilo se uporablja pri bolnikih z boleznijo razreda II ali III.
English: The CHMP decided that Adcirca's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Adcirca večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: A risk management plan has been developed to ensure that Adcirca is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Adcirca je bil pripravljen načrt obvladovanja tveganj.
English: Adcirca was more effective than placebo at improving exercise capacity.
Slovenian: Zdravilo Adcirca je bilo pri izboljšanju telesne zmogljivosti učinkovitejše od placeba.
English: This authorisation was based on the authorisation granted to Cialis in 2002 (‘informed consent').
Slovenian: Izdaja tega dovoljenja je temeljila na dovoljenju za promet z zdravilom Cialis, ki je bilo izdano leta 2002 (uporaba dokumentacije s soglasjem).
English: After 16 weeks, this distance had increased by 26 metres more in the patients taking 40 mg Adcirca than in the patients taking placebo.
Slovenian: Po 16 tednih se je pri bolnikih, ki so jemali 40-miligramski odmerek zdravila Adcirca, ta razdalja povečala za 26 metrov več kot pri tistih, ki so jemali placebo.
English: The most common side effects with Adcirca (seen in more than 1 patient in 10) are headache, flushing (reddening of the skin), nasopharyngitis (inflammation of the nose and throat) including a blocked or runny nose and blocked sinuses, nausea (feeling sick), dyspepsia (heartburn) including stomach ache, myalgia (muscle pain), back pain and pain in the extremities (arms, hands, legs and feet).
Slovenian: Najpogostejši neželeni učinki zdravila Adcirca (opaženi pri več kot 1 bolniku od 10) so glavobol, zardevanje (pordelost kože), nazofaringitis (vnetje nosu in grla), vključno z zamašenim nosom ali izcedkom iz nosu in zamašenimi sinusi, navzeja (slabost), dispepsija (zgaga), vključno z bolečinami v želodcu, mialgija (bolečine v mišicah), bolečine v hrbtu in okončinah (rokah, dlaneh, nogah in stopalih).
English: For more information about treatment with Adcirca, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Adcirca preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Adcirca is a medicine that contains the active substance tadalafil.
Slovenian: Adcirca je zdravilo, ki vsebuje zdravilno učinkovino tadalafil.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Adcirca, 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: This is a summary of the European public assessment report (EPAR) for Adcirca.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Adcirca.