FrancophonIA/ELRC3.0 huggingface dataset:
English: A drug utilisation study will also be conducted to further characterise a possible risk of tolerance, dependence and drug abuse in long-term use in idiopathic restless leg syndrome.
Croatian: Provest će se ispitivanje iskoristivosti lijeka kako bi se dalje okarakterizirali mogući rizici od tolerancije, ovisnosti i zlouporabe lijeka u dugoročnoj primjeni u slučaju idiopatskog sindroma nemirne noge.
English: These findings are in line with the results of the post-marketing surveillance with OXN PR in the treatment of pain where addiction and related abuse are carefully monitored.
Croatian: Ovi nalazi su u skladu s rezultatima nadzora nakon stavljanja lijeka u promet za lijek OXN PR u liječenju boli u slučajevima kada se ovisnost i povezana zlouporaba pažljivo prate.
English: The frequency of adverse events and related adverse events was mostly comparable for both study phases (OXN3502/S) and points to a better tolerability of OXN PR in the extension phase.
Croatian: Učestalost nuspojava i povezanih nuspojava bila je uglavnom usporediva u obje faze ispitivanja (OXN3502/S) i ukazuje na bolju podnošljivost OXN PR-a u produljenoj fazi.
English: • The Committee considered that the amendments to the product information are appropriate to mitigate the risks of iatrogenic drug dependence, drug abuse or misuse, augmentation, tolerance and psychological dependence.
Croatian: • je Odbor zaključio da su dopune informacija o proizvodu odgovarajuće kako bi se smanjili rizici ofiatrogenske ovisnosti o lijeku, zlouporabe ili neispravne primjene lijeka, augmentacije, tolerancije i psihološke ovisnosti.
English: Furthermore, the risk of parenteral or intranasal misuse of OXN PR by individuals dependent on opioid agonists is expected to be low as marked withdrawal symptoms are expected due to the opioid receptor antagonist characteristics of naloxone.
Croatian: Nadalje, očekuje se nizak rizik od parenteralne orintranazalne zlouporabe OXN PR-a od strane pojedinaca ovisnih o opioidnim agonistima budući da se očekuju naznačeni simptomi ustezanja uslijed značajki antagonista opioidnog receptora naloksona.
English: Treatment with OXN PR in RLS has been contraindicated in patients with a history of opioid abuse.
Croatian: Liječenje lijekom OXN PR u slučaju RLS-a kontraindicirano je u bolesnika s poviješću zlouporabe opioida.
English: The CHMP agreed that the risk of physical dependence and associated withdrawal reaction can be mitigated and adequately managed by the strengthened tapering advice proposed.
Croatian: CHMP je suglasan da se rizik od fizičke ovisnosti i povezane reakcije ustezanja može smanjiti te se njime može primjereno upravljati predloženim savjetom za pojačano postupno smanjivanje doze.
English: Grounds for the variation to the terms of the marketing authorisation with amendments to the relevant sections of the summary of product characteristics
Croatian: Razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet s dopunama u relevantnim dijelovima sažetka opisa svojstava lijeka
English: During the CMD(h) referral procedure, the proposed restless legs syndrome indication was restricted to “second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy".
Croatian: Tijekom postupka upućivanja CMD(h)-a, predložena indikacija sindroma nemirnih nogu ograničena je na „drugu liniju simptomatskog liječenja bolesnika s ozbiljnim do vrlo ozbiljnim idopatskim sindromom nemirne noge nakon neučinkovite dopaminergičke terapije“.
English: Background
Croatian: Pozadinske informacije
English: On 31 August 2012, the MAH submitted a type II variation via the mutual recognition procedure (MRP) for Oxynal and Targin and associated names, to request the inclusion of “symptomatic treatment of patients with moderate to severe idiopathic restless legs syndrome insufficiently treated with dopaminergic therapy”.
Croatian: Dana 31. kolovoza 2012. godine, nositelj odobrenja dostavio je varijaciju tipa II putem postupka međusobnog priznavanja (MRP-a) za lijekove Oxynal i Targin te povezane nazive, i zatražio je uključivanje „simptomatičnog liječenja bolesnika s umjerenim do ozbiljnim idiopatskim sindromom nemirnih nogu koji je nedovoljno liječen dopaminergičkom terapijom“.
English: Successful treatment of the idiopathic restless legs syndrome in a randomized double-blind trial of oxycodone versus placebo.
Croatian: Successful treatment of the idiopathic restless legs syndrome in a randomized double-blind trial of oxycodone versus placebo.Sleep 1993; 16: 327-332.
English: No case of augmentation, tolerance, psychological dependence (addiction), abuse or misuse was reported in the studies OXN3502/S.
Croatian: U ispitivanjima OXN3502/S nisu prijavljeni slučajevi augmentacije, tolerancije, psihološke ovisnosti (ovisnosti), zlouporabe ili neispravne primjene.
English: The CHMP considered that the data provided by the MAH are sufficient to support the use of Oxynal and Targin and associated names in the second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy.
Croatian: CHMP je mišljenja da su podaci dostavljeni od strane nositelja odobrenja dostatni za podršku primjene lijekova Oxynal i Targin kao i povezanih naziva u simptomatskom liječenju druge linije bolesnika s ozbiljnim do vrlo ozbiljnim idiopatskim sindromom nemirne noge nakon neuspješne dopaminergičke terapije.
English: • The Committee reviewed all available data in support of the safety and efficacy of Oxynal and Targin and associated names in “second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy”.
Croatian: • je Odbor pregledao sve dostupne podatke koji podržavaju sigurnost i djelotvornost lijekova Oxynal i Targin te povezanih naziva u „simptomatskom liječenju bolesnika s vrlo ozbiljnim idiopatskim sindromom nemirnih nogu nakon neuspješne dopaminergičke terapije“.
English: • The Committee considered that the data of the pivotal phase III study and extension phase part are supportive of short term and long term efficacy of Oxynal and Targin and associated names in the second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy.
Croatian: • je Odbor zaključio kako podaci pivotalne faze III ispitivanja i produljene faze podupiru kratkoročnu i dugoročnu djelotvornost lijekova Oxynal i Targin te povezane nazive u simptomatskoj terapiji druge linije bolesnika s ozbiljnim do vrlo ozbiljnim idiopatskim sindromom nemirne noge nakon neuspješne dopaminergičke terapije.
English: • The Committee concluded, in view of available data, that the benefit risk of Oxynal and Targin and associated names for “second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy” is positive.
Croatian: • je Odbor zaključio, u svjetlu dostupnih podataka, da je omjer koristi i rizika lijekova Oxynal i Targin te povezanih naziva u „simptomatskom liječenju bolesnika s vrlo ozbiljnim idiopatskim sindromom nemirnih nogu nakon neuspješne dopaminergičke terapije“ pozitivan.
English: Therefore, short term efficacy of OXN PR as second line treatment of severe to very severe RLS after failure of dopaminergic treatment has convincingly been shown in the pivotal study OXN3502.
Croatian: Stoga u pivotalnom ispitivanju OXN3502 uvjerljivo je utvrđena kratkoročna djelotvornost OXN PR-a kao terapije druge linije ozbiljnog ili vrlo ozbiljnog RLS-a nakon neuspješne dopaminergičke terapije.
English: · Risk Management Plan (RMP) Not applicable.
Croatian: · Plan upravljanja rizikom (RMP) Nije primjenjivo.
English: Date of latest renewal: 4 September 2014
Croatian: Datum posljednje obnove: 4. rujna 2014.
English: - If you have problems with your heart.
Croatian: - Ako imate poteškoće sa srcem.
English: - If you have a deformity of your penis or Peyronie's Disease.
Croatian: - Ako imate deformaciju penisa ili Peyronijevu bolest.
English: Do not use nitrates to treat your chest pain.
Croatian: Nemojte uzimati nitrate za liječenje bolova u prsima.
English: - If you have recently had a stroke or a heart attack, or if you have low blood pressure.
Croatian: - Ako ste nedavno imali moždani ili srčani udar ili ako imate nizak krvni tlak.
English: - If you have certain rare inherited eye diseases (such as retinitis pigmentosa).
Croatian: - Ako imate određene rijetke nasljedne bolesti oka (kao što je retinitis pigmentosa).
English: Sildenafil Actavis with food and drink and alcohol Sildenafil Actavis can be taken with or without food.
Croatian: Sildenafil Actavis s hranom, pićem i alkoholom Sildenafil Actavis se može uzeti sa ili bez hrane.
English: It is not possible to determine whether these events were directly related to sildenafil.
Croatian: Nije moguće utvrditi jesu li ovi događaji izravno povezani sa sildenafilom.
English: - A sudden decrease or loss of vision - this occurs rarely
Croatian: Iznenadno smanjenje ili gubitak vida - javlja se rijetko
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 December 2009
Croatian: Datum prvog odobrenja: 10. prosinca 2009.
English: In clinical trials sildenafil was administered to more than 8000 patients aged 19-87.
Croatian: U kliničkim ispitivanjima sildenafil je primijenjen kod više od 8000 bolesnika u dobi 19-87 godina.
English: - Prolonged and sometimes painful erections - this occurs rarely (may affect up to 1 in 1,000 people)
Croatian: - Produljene i ponekad bolne erekcije - javljaju se rijetko (mogu se javiti kod do 1 na 1000 osoba)
English: The amount of time Sildenafil Actavis takes to work varies from person to person, but it normally takes between half an hour and one hour.
Croatian: Vrijeme potrebno za početak djelovanja lijeka Sildenafil Actavis razlikuje se od osobe do osobe, ali se obično kreće između pola sata i jednog sata.
English: If you feel that the effect of Sildenafil Actavis is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako osjećate da je učinak lijeka Sildenafil Actavis prejak ili preslab, obratite se svom liječniku ili ljekarniku.
English: Due to the nitrate component it has the potential to result in a serious interaction with sildenafil.
Croatian: Zbog svoje nitratne komponente ima potencijal ozbiljnih interakcija sa sildenafilom.
English: Mean pulmonary systolic blood pressure decreased by 9%.
Croatian: Srednji pulmonalni sistolički krvni tlak snizio se za 9%.
English: In the event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken Sildenafil Actavis and when you did.
Croatian: U slučaju hitne medicinske intervencije, morate upozoriti svog liječnika, ljekarnika ili medicinsku sestru da ste uzeli Sildenafil Actavis te kada ste ga uzeli.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti i reproduktivne i razvojne toksičnosti.
English: Because not all adverse reactions are reported the frequencies of these reactions cannot be reliably determined.
Croatian: S obzirom da sve nuspojave nisu prijavljene, učestalost tih nuspojava nije moguće pouzdano odrediti.
English: Use in adults
Croatian: Primjena u odraslih osoba
English: In vitro studies
Croatian: In vitro ispitivanja
English: In vivo studies
Croatian: In vivo ispitivanja
English: Do not take Sildenafil Actavis with other medicines unless your doctor tells you that you can.
Croatian: Nemojte uzimati Sildenafil Actavis s drugim lijekovima, osim ako Vam tako nije rekao liječnik.
English: - If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy
Croatian: - Ako ste ikada imali gubitak vida zbog nearteritične prednje ishemijske optičke neuropatije
English: What Sildenafil Actavis is and what it is used for What you need to know before you take Sildenafil Actavis How to take Sildenafil Actavis Possible side effects
Croatian: Što je Sildenafil Actavis i za što se koristi Što morate znati prije nego počnete uzimati Sildenafil Actavis Kako uzimati Sildenafil Actavis Moguće nuspojave
English: This is most likely to happen within 4 hours after taking Sildenafil Actavis.
Croatian: To će se najvjerojatnije dogoditi unutar 4 sata nakon uzimanja lijeka Sildenafil Actavis.
English: If you have an erection which lasts for more than 4 hours, you should contact a doctor immediately.
Croatian: Ako imate erekciju koja traje dulje od 4 sata, odmah se obratite svom liječniku.
English: Sildenafil Actavis will only help you to get an erection if you are sexually stimulated.
Croatian: Sildenafil Actavis će Vam pomoći u postizanju erekcije jedino ako ste seksualno stimulirani.
English: Of note, most, but not all, of the men who experienced these side effects had heart problems before taking this medicine.
Croatian: Potrebno je napomenuti kako je većina muškaraca, ali ne svi, koja je imala navedene nuspojave, imala poteškoće sa srcem već prije uzimanja ovog lijeka.
English: You should take Sildenafil Actavis about one hour before sexual activity.
Croatian: Trebate uzeti Sildenafil Actavis oko jedan sat prije planirane spolne aktivnosti.
English: If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your doctor may start you on the lowest dose (25 mg) of Sildenafil Actavis.
Croatian: Ako uzimate lijekove poznate kao inhibitori proteaze, na primjer za liječenje infekcije HIV-om, liječnik Vam može propisati najnižu početnu dozu (25 mg) lijeka Sildenafil Actavis.
English: Sildenafil Actavis tablets may interfere with some medicines, especially those used to treat chest pain.
Croatian: Sildenafil Actavis tablete mogu međusobno djelovati s nekim lijekovima, osobito onima koji se koriste za liječenje boli u prsima.
English: Certain patients have experienced these symptoms when taking sildenafil with alpha-blockers.
Croatian: Određeni bolesnici imali su te simptome prilikom uzimanja sildenafila s alfa-blokatorima.
English: To get the maximum benefit from your medicine, you are advised not to drink excessive amounts of alcohol before taking Sildenafil Actavis.
Croatian: Kako biste izvukli najviše koristi od lijeka, savjetuje se da ne uzimate veće količine alkohola prije uzimanja lijeka Sildenafil Actavis.
English: Sildenafil Actavis should not be given to individuals under the age of 18.
Croatian: Sildenafil Actavis se ne smije davati osobama mlađim od 18 godina.
English: In the table below all medically important adverse reactions, which occurred in clinical trials at an incidence greater than placebo are listed by system organ class and frequency (very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000)).
Croatian: U donjoj tablici navedene su sve medicinski značajne nuspojave koje su se javile u kliničkim ispitivanjima s incidencijom većom nego kod placeba razvrstane prema organskim sustavima i učestalosti (vrlo često (≥1/10), često (≥1/100 do <1/10), manje često (≥1/1000 do <1/100), rijetko (≥1/10 000 do <1/1000)).
English: Special considerations for patients with kidney or liver problems You should tell your doctor if you have kidney or liver problems.
Croatian: Posebna upozorenja za bolesnike s poremećajem bubrega ili jetre Obavijestite svog liječnika ako imate poteškoće s bubrezima ili jetrom.
English: 1 film-coated tablet 2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 12 film-coated tablets 24 film-coated tablets
Croatian: 1 filmom obložena tableta 2 filmom obložene tablete 4 filmom obložene tablete 8 filmom obloženih tableta 12 filmom obloženih tableta 24 filmom obložene tablete
English: Patients should be advised that in the event of any sudden visual defect, they should stop taking Sildenafil Actavis and consult a physician immediately (see section 4.3).
Croatian: Bolesnike treba savjetovati da u slučaju bilo kakvog iznenadnog poremećaja vida prestanu uzimati Sildenafil Actavis i odmah zatraže savjet liječnika (vidjeti dio 4.3).
English: What Sildenafil Actavis is and what it is used for
Croatian: Što je Sildenafil Actavis i za što se koristi
English: You should not take Sildenafil Actavis if you are a woman.
Croatian: Ne smijete uzimati Sildenafil Actavis ako ste žena.
English: As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they react to Sildenafil Actavis, before driving or operating machinery.
Croatian: Budući da su omaglica i poremećaj vida zabilježeni u kliničkim ispitivanjima sa sildenafilom, bolesnici moraju biti svjesni na koji način oni reagiraju na Sildenafil Actavis prije upravljanja vozilima ili rada sa strojevima.
English: After a single oral dose of 100 mg, the mean maximum total plasma concentration of sildenafil is approximately 440 ng/mL (CV 40%).
Croatian: Nakon jednokratne oralne doze od 100 mg srednja maksimalna ukupna koncentracija sildenafila u plazmi iznosi približno 440 ng/ml (CV 40%).
English: The mean steady state volume of distribution (Vd) for sildenafil is 105 l, indicating distribution into the tissues.
Croatian: Srednji volumen distribucije u stanju dinamičke ravnoteže (Vd) za sildenafil iznosi 105 l što upućuje na distribuciju u tkiva.
English: Table 1: Medically important adverse reactions reported at an incidence greater than placebo in controlled clinical studies and medically important adverse reactions reported through post-marketing surveillance
Croatian: Tablica 1: Medicinski značajne nuspojave zabilježene s incidencijom većom od placeba u kontroliranim kliničkim ispitivanjima i medicinski značajne nuspojave zabilježene u razdoblju nakon stavljanja lijeka u promet
English: Sildenafil Actavis potentiates the hypotensive effect of nitrates (see section 4.3).
Croatian: Sildenafil Actavis pojačava hipotenzivne učinke nitrata (vidjeti dio 4.3).
English: You should not take Sildenafil Actavis more than once a day.
Croatian: Sildenafil Actavis se ne smije uzeti više od jedanput na dan.
English: Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50>150 µM).
Croatian: Sildenafil je slabi inhibitor citokroma P450 izoformi 1A2, 2C9, 2C19, 2D6, 2E1 i 3A4 (IC50 >150 mM).
English: In healthy volunteers receiving sildenafil (100 mg single dose), less than 0.0002% (average 188 ng) of the administered dose was present in ejaculate 90 minutes after dosing.
Croatian: U zdravih dobrovoljaca koji su primali sildenafil (100 mg u jednokratnoj dozi) manje od 0,0002% (prosječno 188 ng) primijenjene doze prisutno je u ejakulatu 90 minuta nakon doziranja.
English: Given sildenafil peak plasma concentrations of approximately 1 µM after recommended doses, it is unlikely that Sildenafil Actavis will alter the clearance of substrates of these isoenzymes.
Croatian: S obzirom da su nakon preporučenih doza vršne koncentracije sildenafila u plazmi približno 1 mM, nije vjerojatno da će Sildenafil Actavis promijeniti klirens supstrata tih izoenzima.
English: Sildenafil Actavis can cause dizziness and can affect vision.
Croatian: Sildenafil Actavis može uzrokovati omaglicu i utjecati na vid.
English: Sildenafil Actavis is indicated in adult men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
Croatian: Sildenafil Actavis je indiciran u odraslih muškaraca s erektilnom disfunkcijom, odnosno nemogućnošću postizanja ili održavanja penilne erekcije dostatne za zadovoljavajuću seksualnu aktivnost.
English: In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased 79% and 200% respectively.
Croatian: Nadalje, vrijednosti AUC i Cmax N-dezmetil metabolita bile su značajno povećane, 79% odnosno 200%.
English: Sildenafil Actavis is a treatment for adult men with erectile dysfunction, sometimes known as impotence.
Croatian: Sildenafil Actavis je lijek namijenjen liječenju odraslih muškaraca s erektilnom disfunkcijom, ponekad zvanom impotencija.
English: PDE5 inhibitors, such as Sildenafil Actavis have been shown to increase the hypotensive effects of this medicine.
Croatian: PDE5 inhibitori, kao što je Sildenafil Actavis su pokazali da povećavaju hipotenzivne učinke ovog lijeka.
English: Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or light-headedness, which may be caused by low blood pressure upon sitting or standing up quickly.
Croatian: Pojedini bolesnici koji uzimaju alfa-blokatore za liječenje visokog krvnog tlaka ili povećanja prostate mogu imati omaglicu ili ošamućenost što može biti uzrokovano sniženjem krvnog tlaka nakon naglog uspravljanja u sjedeći ili stojeći položaj.
English: Your doctor may start you on a lower dose (25 mg) of Sildenafil Actavis.
Croatian: Liječnik Vas može staviti na početnu nižu dozu (25 mg) lijeka Sildenafil Actavis.
English: 6.4 Special precautions for storage Store below 30°C.
Croatian: POSEBNE MJERE ČUVANJA Čuvati na temperaturi ispod 30°C.
English: In order for Sildenafil Actavis to be effective, sexual stimulation is required.
Croatian: Kako bi Sildenafil Actavis djelovao, neophodna je seksualna stimulacija.
English: Pregnancy, breast-feeding and fertility Sildenafil Actavis is not indicated for use by women.
Croatian: Trudnoća, dojenje i plodnost Sildenafil Actavis nije namijenjen za primjenu u žena.
English: There is no safety information on the administration of sildenafil to patients with bleeding disorders or active peptic ulceration.
Croatian: Nema informacija o sigurnosti primjene sildenafila u bolesnika s poremećajima krvarenja ili aktivnim peptičkim ulkusom.
English: In addition, the frequency of medically important adverse reactions reported from post-marketing experience is included as not known.
Croatian: Pored toga, učestalost medicinski značajnih nuspojava zabilježenih nakon stavljanja lijeka u promet označena je kao nije poznato.
English: Talk to your doctor, pharmacist or nurse before taking Sildenafil Actavis - If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow).
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Sildenafil Actavis - Ako imate anemiju srpastih stanica (poremećaj crvenih krvnih stanica), leukemiju (rak krvnih stanica), multipli mijelom (rak koštane srži).
English: Stevens-Johnson Syndrome (SJS),*
Croatian: Stevens-Johnsonov sindrom (SJS), * toksična epidermalna nekroliza (TEN) *
English: If Sildenafil Actavis is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2).
Croatian: Ako se Sildenafil Actavis uzima s hranom, nastup djelovanja može biti odgođen u usporedbi s uzimanjem natašte (vidjeti dio 5.2).
English: Tell your doctor if you are taking any of these medicines which are often given for relief of angina pectoris (or “chest pain”).
Croatian: Obavijestite svog liječnika ako uzimate bilo koji od ovih lijekova koji se često koriste za ublažavanje angine pektoris (ili „boli u prsima“).
English: Adverse reactions from post-marketing surveillance has been gathered covering an estimated period >10 years.
Croatian: Nuspojave nakon stavljanja lijeka u promet prikupljene su u razdoblju procijenjenom na >10 godina.
English: Sildenafil Actavis is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
Croatian: Sildenafil Actavis je kontraindiciran u bolesnika koji su izgubili vid na jednom oku zbog nearteritične anteriorne ishemijske optičke neuropatije (NAION), bez obzira je li ta epizoda bila u vezi ili ne s prethodnom izloženošću PDE5 inhibitoru (vidjeti dio 4.4).