FrancophonIA/ELRC3.0 huggingface dataset:
English: Insomnia Anxiety Irritability Depression Sleep disorder
Polish: Bezsenność Zaburzenia lękowe Rozdrażnienie Depresja Zaburzenia snu
English: Figure 3: Changes in Epworth Sleepiness Scale Score (ESS) (mean ± SEM) from Baseline to week 7 in Harmony CTP study
Polish: Rysunek 3: Zmiany wyniku w skali senności Epwortha (średnia ± SEM) od punktu wyjściowego do tygodnia 7 w badaniu Harmony CTP
English: The observed WRC in pitolisant group was about half of WRC in the placebo group: the effect size of pitolisant compared with placebo was summarized by the ratio rate rR(Pt/Pb), rR=0.512; 95%CI [0.435 to 0.603]; p < 0.0001).
Polish: Wielkość efektu pitolisantu w porównaniu z placebo podsumowano za pomocą współczynnika częstości rR(Pt/Pb), rR = 0,512; 95% CI [od 0,435 do 0,603]; p < 0,0001).
English: Rebound effect
Polish: Efekt z odbicia
English: How to store Wakix
Polish: Jak przechowywać lek Wakix
English: At high doses, pitolisant induced sperm morphology abnormalities and decreased motility without any significant effect on fertility indexes in male rats and it decreased the percentage of live conceptuses and increased post-implantation loss in female rats (safety margin of 1).
Polish: W wysokich dawkach pitolisant wywoływał nieprawidłowości w morfologii plemników oraz zmniejszał ich ruchliwość bez znacznego wpływu na wskaźniki płodności u samców szczurów.
English: Wakix 18 mg comes in a white, round, film-coated tablet of 7.5 mm, biconvex marked with “20” on one side.
Polish: Wakix 18 mg: biała, okrągła, obustronnie wypukła tabletka powlekana o średnicy 7,5 mm oznaczona liczbą „20” na jednej stronie.
English: - High blood level of the enzyme creatinine phosphokinase, abnormal general physical condition, modification of the electrical registration of the heart (ECG)
Polish: Zwiększenie stężenia fosfokinazy kreatynowej Nieprawidłowy ogólny stan fizyczny Nieprawidłowa repolaryzacja w EKG Odwrócenie załamka T w EKG
English: Toxic skin eruption Photosensitivity
Polish: Wykwity skórne o podłożu toksycznym Nadwrażliwość na światło
English: Wakix 4.5 mg comes in a white, round, film-coated tablet of 3.7 mm, biconvex marked with “5” on one side.
Polish: Wakix 4,5 mg: biała, okrągła, obustronnie wypukła tabletka powlekana o średnicy 3,7 mm oznaczona cyfrą „5” na jednej stronie.
English: High density polyethylene (HDPE) bottle with a tamper evident, child-resistant, polypropylene screw cap fitted with desiccant (silica gel).
Polish: Butelka z polietylenu o dużej gęstości z nakrętką polipropylenową z zabezpieczeniem przed otwarciem i dostępem dla dzieci oraz środkiem suszącym (żelem krzemionkowym).
English: Pitolisant/metabolites were shown to cross the placenta barrier in animals.
Polish: U zwierząt pitolisant/metabolity przenikają przez łożysko.
English: Pitolisant should be administered with caution in patients with either renal impairment or moderate hepatic impairment (Child-Pugh B) and dosing regimen should be adapted according to section 4.2.
Polish: Należy zachować ostrożność, podając pitolisant pacjentom z zaburzeniami czynności nerek lub umiarkowanymi zaburzeniami czynności wątroby (klasa B wg skali Childa-Pugha).
English: Arthralgia Back pain Muscle rigidity Muscular weakness Musculoskeletal pain Myalgia Pain in extremity
Polish: Bóle stawów Ból pleców Sztywność mięśni Osłabienie mięśni Ból mięśniowo-szkieletowy Mialgia Bóle kończyn
English: No rebound effect was reported during clinical trials.
Polish: W badaniach klinicznych nie stwierdzono efektu z odbicia.
English: Electrocardiogram QT prolonged Heart rate increased Gammaglutamyltransferase increased
Polish: Zwiększenie masy ciała Zmniejszenie masy ciała Zwiększenie aktywności enzymów wątrobowych Wydłużenie odstępu QT w badaniu EKG Zwiększenie częstości skurczów serca Zwiększenie aktywności gammaglutamylotransferazy
English: stomach pain and discomfort, gastritis, excessive acidity of the gastrointestinal tract - Itching, skin condition of the face where the nose and cheeks are unusually red, excessive sweating - Joint pain, back pain, muscle rigidity, muscle weakness, pain of the muscle and the bones, pain in the toes and in the fingers - Abnormal urination - Irregular uterine bleeding - Loss of strength or extreme tiredness, chest pain, malaise, oedema - Weight increase, weight decrease, abnormal reading (ECG) of the heart, abnormal blood values related to the function of the liver.
Polish: nieżyt żołądka, nadkwasota układu żołądkowo-jelitowego - Świąd, nietypowe zaczerwienienie nosa i policzków, nadmierna potliwość - Ból stawów, ból pleców, sztywność mięśniowa, słabość mięśni, ból mięśni i kości, ból palców - Zaburzenia oddawania moczu - Nieregularne krwawienia z macicy - Utrata siły lub skrajne zmęczenie, ból w klatce piersiowej, ogólne złe samopoczucie, obrzęk
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.
Polish: - jeśli pacjent ma uczulenie na pitolisant lub którykolwiek z pozostałych składników tego leku (wymienionych w punkcie 6); - jeśli pacjent ma problemy z wątrobą, gdyż pitolisant, zazwyczaj rozkładany w wątrobie, u pacjentów, u których funkcjonowanie wątroby jest poważnie ograniczone, może się nadmiernie gromadzić; - jeśli pacjentka karmi piersią.
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
Polish: Działania niepożądane występujące rzadko (mogą dotyczyć nie więcej niż 1 na 1000 osób): - Utrata apetytu, zwiększony apetyt - Zachowanie nietypowe, stan splątania, obniżony nastrój, pobudliwość, dyskomfort emocjonalny i psychiczny, omamy wzrokowe i słuchowe podczas snu - Utrata przytomności, napięciowy ból głowy, problemy z pamięcią, słaba jakość snu - Dyskomfort w jamie brzusznej, trudność lub ból podczas połykania, wzdęcia, stan zapalny przewodu pokarmowego - Zakażenie skóry, nietypowa nadmierna wrażliwość na światło słoneczne - Ból szyi, ból w klatce piersiowej - Poronienie - Ból, nocne poty, poczucie ucisku - Wysokie stężenie fosfokinazy kreatynowej we krwi, nieprawidłowy ogólny stan fizyczny,
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Polish: WYTWÓRCY BIOLOGICZNEJ SUBSTANCJI CZYNNEJ ODPOWIEDZIALNI ZA ZWOLNIENIE SERII
English: Tinnitus
Polish: Otoczka
English: Polska
Polish: Latvija
English: However no increase in dopamine release in the striatal complex including nucleus accumbens was evidenced for pitolisant.
Polish: Nie stwierdzono jednak by pitolisant zwiększał uwalnianie dopaminy w prążkowiu, w tym w jądrze półleżącym.
English: Do not stop taking Wakix suddenly on your own.
Polish: Nie należy samodzielnie zaprzestawać przyjmowania leku Wakix.
English: Wakix 4.5 mg tablet Each tablet contains 5 mg of pitolisant hydrochloride, equivalent to 4.45 mg of pitolisant
Polish: Wakix, 4,5 mg tabletka Każda tabletka zawiera 5 mg pitolisantu w postaci chlorowodorku, co odpowiada 4,45 mg pitolisantu
English: Wakix 18 mg film-coated tablets Pitolisant
Polish: Wakix, 18 mg tabletki powlekane Pitolisant
English: Headache Dizziness Tremor
Polish: Jadłowstręt Żarłoczność Zaburzenia łaknienia
English: - You are obese or anorexic, as you may have change of your body weight (increase or decrease)
Polish: gdyż u osób przyjmujących lek Wakix zgłaszano problemy gastryczne; - cierpi na otyłość lub anoreksję, ze względu na możliwe zmiany masy ciała (zwiększenie lub zmniejszenie) podczas przyjmowania leku Wakix; - ma problemy z sercem.
English: Each film-coated tablet of Wakix 4.5 mg contains 5 mg of pitolisant hydrochloride, equivalent to 4.45 mg of pitolisant.
Polish: Każda tabletka produktu leczniczego Wakix 4,5 mg zawiera 5 mg chlorowodorku pitolisantu, co odpowiada 4,45 mg pitolisantu.
English: Wakix 4.5 mg film-coated tablets Pitolisant
Polish: Wakix, 4,5 mg tabletki powlekane Pitolisant
English: White, round, biconvex film-coated tablet, 3.7 mm diameter, marked with “5” on one side.
Polish: Biała, okrągła, obustronnie wypukła tabletka powlekana o średnicy 3,7 mm, oznaczona cyfrą „5” na jednej stronie.
English: Each film-coated tablet of Wakix 18 mg contains 20 mg of pitolisant hydrochloride equivalent to 17.8 mg of pitolisant.
Polish: Każda powlekana tabletka produktu leczniczego Wakix 18 mg zawiera 20 mg chlorowodorku pitolisantu, co odpowiada 17,8 mg pitolisantu.
English: Wakix 4.5 mg film-coated tablets Wakix 18 mg film-coated tablets
Polish: Wakix, 4,5 mg tabletki powlekane Wakix, 18 mg tabletki powlekane
English: - Are breastfeeding.
Polish: Karmienie piersią
English: QT-prolonging substances or known to increase the risk of repolarization disorders
Polish: Substancje wydłużające odstęp QT lub zwiększające ryzyko wystąpienia zaburzeń repolaryzacji Należy dokładnie monitorować jednoczesne przyjmowanie tych substancji z pitolisantem (patrz punkt
English: Common side effects (may affect up to 1 in 10 people): - Difficulty in sleeping, feeling anxious, feeling irritable, feeling depressed, sleeping problems
Polish: Działania niepożądane występujące często (mogą dotyczyć nie więcej niż 1 na 10 osób): - Trudności w zasypianiu, zaburzenia lękowe, rozdrażnienie, przygnębienie, problemy ze snem - Bóle głowy, uczucie „wirowania” (zawroty głowy), utrata równowagi, drżenia - Nudności, wymioty, niestrawność - Zmęczenie
English: Wakix 4.5 mg film-coated tablets Wakix 18 mg film-coated tablets Pitolisant
Polish: Wakix, 4,5 mg tabletki powlekane Wakix, 18 mg tabletki powlekane Pitolisant
English: White, round, biconvex film-coated tablet, 7.5 mm diameter marked with “20” on one side.
Polish: Biała, okrągła, obustronnie wypukła tabletka powlekana o średnicy 7,5 mm, oznaczona liczbą „20” na jednej stronie.
English: Dyskinesia Balance disorder Cataplexy Disturbance in attention Dystonia On and off phenomenon Hypersomnia Migraine Psychomotor hyperactivity Restless Legs Syndrome Somnolence Epilepsy Bradykinesia Paresthesia
Polish: Zespół on-off Hipersomnia Migrena Nadpobudliwość psychoruchowa Zespół niespokojnych nóg Senność Padaczka Bradykinezja Parestezja
English: Talk to your doctor before taking Wakix if any of the situations mentioned below apply to you:
Polish: Informacje ważne przed zastosowaniem leku Wakix Kiedy nie stosować leku Wakix:
English: Wakix 4.5 mg film-coated tablet
Polish: Wakix, 4,5 mg tabletka powlekana
English: Wakix 18 mg film-coated tablet
Polish: Wakix, 18 mg tabletka powlekana
English: Asthenia Chest Pain Feeling Abnormal Malaise Oedema Peripheral oedema
Polish: Astenia Ból w klatce piersiowej Nietypowe samopoczucie Złe samopoczucie Obrzęki Obrzęk obwodowy
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.
Polish: Co to jest lek Wakix i w jakim celu się go stosuje Informacje ważne przed zastosowaniem leku Wakix Jak zażywać lek Wakix
English: - You have heart problems.
Polish: Zaburzenia serca
English: - If you get any side effects, talk to your doctor or pharmacist.
Polish: - Jeśli wystąpią jakiekolwiek objawy niepożądane, należy poinformować o tym lekarza lub farmaceutę.
English: Visual acuity reduced Blepharospasm
Polish: Zmniejszona ostrość widzenia Kurcz powiek
English: If you get any side effects, talk to your doctor or pharmacist.
Polish: Jeśli wystąpią jakiekolwiek objawy niepożądane, należy poinformować o tym lekarza lub farmaceutę.
English: Wakix 18 mg tablet Each tablet contains 20 mg of pitolisant hydrochloride, equivalent to 17.8 mg of pitolisant.
Polish: Każda tabletka zawiera 20 mg pitolisantu w postaci chlorowodorku, co odpowiada 17,8 mg pitolisantu.
English: If you forget to take Wakix
Polish: Pominięcie przyjęcia leku Wakix
English: Drug-drug interactions
Polish: Interakcje lek-lek
English: Metrorrhagia
Polish: Metabolizm
English: Your doctor will need to check this regularly while you are taking
Polish: Pacjent będzie musiał być regularnie monitorowany w tym zakresie podczas przyjmowania leku Wakix; - ma ciężką postać padaczki.
English: Nausea Vomiting Dyspepsia
Polish: Zaburzenia żołądka i jelit
English: If you stop taking Wakix
Polish: Przerwanie przyjmowania leku Wakix
English: Malta Bioprojet Pharma contact@bioprojet.com
Polish: España Bioprojet Pharma contact@bioprojet.com
English: Wakix may reduce the effectiveness of hormonal contraceptives, an alternative method of effective contraception has to be used (see section “Pregnancy).
Polish: Należy stosować alternatywną skuteczną metodę antykoncepcyjną (patrz punkt „Ciąża”).
English: Hepatic or renal impairment
Polish: Zaburzenia nerek i dróg moczowych
English: Pharmaceutical Form Route of Administration
Polish: Postać farmaceutyczna Droga podania Rodzaj opakowania Wielkość opakowania
English: Page 2/2
Polish: Página 2/2
English: This summary was last updated in 04-2015.
Polish: Este resumo foi atualizado pela última vez em 04-2015.
English: The medicine can only be obtained with a prescription.
Polish: O medicamento só pode ser obtido mediante receita médica.
English: The medicine usually starts to have an effect after four to six weeks.
Polish: O efeito do medicamento começa normalmente a manifestar-se após quatro a seis semanas.
English: The applicant presented data on experimental models from the scientific literature.
Polish: O requerente apresentou dados relativos a modelos experimentais constantes da literatura científica.
English: It is available as white round tablets (10 and 20 mg).
Polish: Está disponível em comprimidos redondos brancos (10 e 20 mg).
English: EPAR summary for the public
Polish: Resumo do EPAR destinado ao público
English: Its effect may improve further for up to six months.
Polish: As melhorias podem acentuar-se durante seis meses, no máximo.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Polish: Dois medicamentos são bioequivalentes quando produzem os mesmos níveis da substância ativa no organismo.
English: For more information on generic medicines, see the question-and-answer document here.
Polish: Para mais informações sobre medicamentos genéricos, ver o documento de perguntas e respostas aqui.
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.
Polish: O EPAR completo relativo ao Leflunomida ratiopharm pode ser consultado no sítio Internet da Agência em: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Therefore, the CHMP's view was that, as for Arava, the benefit outweighs the identified risk.
Polish: Por conseguinte, o CHMP considerou que, à semelhança do Arava, os seus benefícios são superiores aos riscos identificados.
English: This means that Leflunomide ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Arava.
Polish: Isto significa que é similar a um medicamento de referência já autorizado na União Europeia (UE) denominado 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.
Polish: O seu objetivo é explicar o modo como o Comité dos Medicamentos para Uso Humano (CHMP) avaliou o medicamento a fim de emitir um parecer favorável à concessão de uma autorização de introdução no mercado, bem como as suas recomendações sobre as condições de utilização do Leflunomida ratiopharm.
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.
Polish: A dose de manutenção recomendada é de 10 a 20 mg uma vez por dia em doentes com artrite reumatoide, e de 20 mg uma vez ao dia em doentes com artrite psoriática.
English: For more information about treatment with Leflunomide ratiopharm, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Polish: Para mais informações sobre o tratamento com o Leflunomida ratiopharm, leia o Folheto Informativo (também parte do EPAR) ou contacte o seu médico ou farmacêutico.
English: With fewer lymphocytes, there is less inflammation, helping to control the symptoms of arthritis.
Polish: Com um menor número de linfócitos há uma menor inflamação, o que ajuda a controlar os sintomas da artrite.
English: This is a summary of the European public assessment report (EPAR) for Leflunomide ratiopharm.
Polish: Este é um resumo do Relatório Público Europeu de Avaliação (EPAR) relativo ao Leflunomida ratiopharm.
English: Leflunomide ratiopharm treatment starts with a ‘loading dose' of 100 mg once a day for three days, followed by a maintenance dose.
Polish: O tratamento com o Leflunomida ratiopharm deve ser iniciado com uma dose de carga de 100 mg uma vez por dia, durante três dias, seguida de uma dose de manutenção.
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.
Polish: O CHMP concluiu que, em conformidade com o exigido pela legislação comunitária, o Leflunomida ratiopharm demonstrou ter uma qualidade comparável e ser bioequivalente ao Arava.
English: Leflunomide ratiopharm treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis.
Polish: O tratamento com o Leflunomida ratiopharm deve ser iniciado e supervisionado por um especialista com experiência no tratamento da artrite reumatoide e da artrite psoriática.
English: Leflunomide ratiopharm EMA/438073/2015
Polish: Leflunomida ratiopharm EMA/279503/2015
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).
Polish: O Leflunomida ratiopharm é utilizado no tratamento de adultos com artrite reumatoide ativa (doença do sistema imunitário que provoca inflamação das articulações) ou artrite psoriática ativa (uma doença que provoca o aparecimento de placas avermelhadas recobertas por escamas na pele e inflamação das articulações).
English: It reduces inflammation by reducing the production of immune cells called ‘lymphocytes', which are responsible for inflammation.
Polish: Esta substância reduz a inflamação através da redução da produção de células do sistema imunitário chamadas linfócitos, que são as células responsáveis pela inflamação.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Leflunomide ratiopharm on 29 November 2010.
Polish: Em 29 de novembro de 2010, a Comissão Europeia concedeu uma Autorização de Introdução no Mercado, válida para toda a União Europeia, para o medicamento Leflunomida ratiopharm.
English: Leflunomide does this by blocking an enzyme called ‘dihydroorotate dehydrogenase', which is necessary for the lymphocytes to multiply.
Polish: A leflunomida bloqueia uma enzima chamada dihidroorotato desidrogenase, que é necessária para a multiplicação dos linfócitos.
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.
Polish: Uma vez que o Leflunomida ratiopharm é um medicamento genérico, os estudos em doentes limitaram-se a testes para demonstrar que é bioequivalente ao medicamento de referência, o Arava.
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.
Polish: Uma vez que o Leflunomida ratiopharm é um medicamento genérico bioequivalente ao medicamento de referência, parte-se do princípio de que os seus benefícios e riscos são idênticos aos do medicamento de referência.
English: The active substance in Leflunomide ratiopharm, leflunomide, is an immunosuppressant.
Polish: A substância ativa do Leflunomida ratiopharm, a leflunomida, é um imunossupressor.
English: The Committee recommended that Leflunomide ratiopharm be given marketing authorisation.
Polish: O Comité recomendou a concessão de uma autorização de introdução no mercado para o Leflunomida ratiopharm.
English: Leflunomide ratiopharm is a medicine that contains the active substance leflunomide.
Polish: O Leflunomida ratiopharm é um medicamento que contém a substância ativa leflunomida.
English: What are the benefits and risks of Leflunomide ratiopharm?
Polish: Quais os benefícios e os riscos do Leflunomida ratiopharm?
English: Leflunomide ratiopharm is a ‘generic medicine'.
Polish: O Leflunomida ratiopharm é um medicamento genérico.
English: Other information about Leflunomide ratiopharm
Polish: Outras informações sobre o Leflunomida ratiopharm
English: Leflunomide ratiopharm leflunomide
Polish: Leflunomida ratiopharm leflunomida
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.
Polish: O médico deve efetuar análises ao sangue para avaliar a função hepática do doente e os níveis de glóbulos brancos e de
English: Why has Leflunomide ratiopharm been approved?
Polish: Por que foi aprovado o Leflunomida ratiopharm?
English: How is Leflunomide ratiopharm used?
Polish: Como se utiliza o Leflunomida ratiopharm?
English: How has Leflunomide ratiopharm been studied?
Polish: Como foi estudado o Leflunomida ratiopharm?
English: What is Leflunomide ratiopharm used for?
Polish: Para que é utilizado o Leflunomida ratiopharm?
English: What is Leflunomide ratiopharm?
Polish: O que é o Leflunomida ratiopharm?
English: How does Leflunomide ratiopharm work?
Polish: Como funciona o Leflunomida ratiopharm?
English: The name of the medicine was changed to Adcirca on 21 October 2009.
Polish: W dniu 21 października 2009 r. nazwę leku zmieniono na Adcirca.
English: Before treatment, the patients could walk an average of 343 metres in six minutes.
Polish: Przed leczeniem pacjenci byli w stanie przejść średnio 343 metry w ciągu 6 minut.
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.
Polish: Pełne sprawozdanie EPAR dotyczące leku Adcirca znajduje się na stronie internetowej Agencji pod adresem: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: tadalafil
Polish: Adcirca tadalafil
English: Previously known as Tadalafil Lilly.
Polish: Wcześniej pod nazwą Tadalafil Lilly.
English: What measures are being taken to ensure the safe and effective use of Adcirca?
Polish: Jakie środki są podejmowane w celu zapewnienia bezpiecznego i skutecznego stosowania produktu Adcirca?
English: What is Adcirca?
Polish: Co to jest Adcirca?
English: Adcirca is used in patients with class II or III disease.
Polish: Lek Adcirca stosuje się u pacjentów z chorobą II lub III klasy.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom necessary depending on the patient's response.
Polish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Adcirca is a medicine that contains the active substance tadalafil.
Polish: Adcirca jest lekiem zawierającym substancję czynną tadalafil.
English: This authorisation was based on the authorisation granted to Cialis in 2002 (‘informed consent').
Polish: Podstawą przyznania pozwolenia było pozwolenie przyznane w 2002 r. dla produktu Cialis (w ramach „zgody po uprzednim poinformowaniu”).