FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Farydak, 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 means that for patients who have previously received at least two previous treatments, including bortezomib and immunomodulatory agents, who have limited treatment options and therefore a high unmet medical need, it offers a new alternative.
Slovenian: To pomeni, da ponuja novo alternativo bolnikom, ki so predhodno že prejeli vsaj dve zdravljenji, vključno z bortezomibom in imunomodulacijskimi zdravili, in imajo omejene možnosti zdravljenja, kar kaže na veliko neizpolnjeno potrebo po zdravilu.
English: Farydak is a cancer medicine used in combination with two other medicines, bortezomib and dexamethasone, to treat multiple myeloma (a cancer of the bone marrow).
Slovenian: Farydak je zdravilo proti raku, ki se v kombinaciji z dvema drugima zdraviloma, bortezomibom in deksametazonom, uporablja za zdravljenje multiplega mieloma (raka kostnega mozga).
English: In multiple myeloma, panobinostat is expected to keep genes that suppress the division and growth of the cancer cells switched ‘on'.
Slovenian: Pri multiplem mielomu panobinostat ohranja gene, ki zavirajo delitev in rast rakavih celic, „vklopljene“.
English: The doctor may have to adjust or
Slovenian: lahko zdravnik odmerek prilagodi ali ga prestavi na poznejši čas.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom delay the dose in patients who experience severe side effects.
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
English: It is not intended to provide practical advice on how to use Farydak.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Treatment with Farydak must be started by a doctor experienced in the treatment of cancer and the medicine can only be obtained with a prescription.
Slovenian: Izdaja zdravila Farydak je le na recept, zdravljenje z njim pa mora začeti zdravnik, ki ima izkušnje z zdravljenjem raka.
English: The medicine was compared with placebo (a dummy treatment) as an addition to treatment with bortezomib and dexamethasone.
Slovenian: Zdravilo Farydak so primerjali s placebom (zdravilom brez zdravilne učinkovine), ko so ju dodajali zdravljenju z bortezomibom in deksametazonom.
English: How does Farydak work?
Slovenian: Kako zdravilo Farydak deluje?
English: Farydak contains the active substance panobinostat.
Slovenian: Zdravilo Farydak vsebuje zdravilno učinkovino panobinostat.
English: How is Farydak used?
Slovenian: Kako se zdravilo Farydak uporablja?
English: Packaging Content Package size
Slovenian: Ovojnina Velikost pakiranja
English: Consideration should be given to the following:
Slovenian: Upoštevati je treba naslednje:
English: Therefore, M4 accounts for approximately 4% of total pharmacologic activity.
Slovenian: Zato M4 prispeva približno 4% k celotnemu farmakološkemu delovanju.
English: ATC code: G04BE10.
Slovenian: Oznaka ATC: G04BE10.
English: Avanafil is rapidly absorbed.
Slovenian: Avanafil se hitro absorbira.
English: • pink or red urine, blood in the urine
Slovenian: • rožnat ali rdeč urin, kri v urinu
English: There was no effect on the extent of exposure (AUC).
Slovenian: Vpliva na stopnjo izpostavljenosti (AUC) niso opazili.
English: • If you are taking riociguat.
Slovenian: • če jemljete riociguat.
English: Drinking alcohol may also decrease your ability to get an erection.
Slovenian: Pitje alkohola lahko tudi zmanjša vašo zmožnost doseganja erekcije.
English: Spedra should not be taken by children and adolescents under 18 years of age.
Slovenian: Zdravila Spedra ne smejo jemati otroci in mladostniki, mlajši od 18 let.
English: • sudden decrease or loss of vision in one or both eyes.
Slovenian: • nenadno poslabšanje ali izguba vida na enem ali obeh očesih;
English: Concomitant use of alcohol
Slovenian: Sočasna uporaba alkohola
English: Spedra can be taken with or without food; if taken with food, it may take longer to work.
Slovenian: Zdravilo Spedra se lahko jemlje s hrano ali brez nje; če ga jemljete s hrano, bo morda trajalo dlje, da bo začelo učinkovati.
English: The use of avanafil is contraindicated in:
Slovenian: Uporaba avanafila je kontraindicirana pri:
English: You should not take Spedra more than once a day.
Slovenian: Zdravila Spedra ne smete vzeti več kot enkrat na dan.
English: • If you suffer from priapism, that is a persistent erection lasting 4 hours or more.
Slovenian: • če imate „priapizem“ - to je neprekinjeno erekcijo, ki traja 4 ure ali več.
English: • spontaneous erection without sexual stimulation
Slovenian: • spontana erekcija brez spolne stimulacije
English: • If you are allergic to avanafil or any of the other ingredients of this medicine (listed in section 6)
Slovenian: • če ste alergični na avanafil ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: In cases of overdose, standard supportive measures should be adopted as required.
Slovenian: V primeru prevelikega odmerjanja so potrebni ustrezni standardni podporni ukrepi.
English: If this happens, do not drive, cycle, use tools or machines.
Slovenian: Če opazite karkoli od naštetega, ne smete voziti, kolesariti ali upravljati orodij in strojev.
English: It is not known if these problems are related directly to Spedra, other diseases that you may have or a combination of factors.
Slovenian: Ni znano, ali so te težave povezane neposredno z zdravilom Spedra, drugimi boleznimi, ki jih morda imate, ali pa so posledica kombinacije teh dejavnikov.
English: Elderly(≥ 65 years old)
Slovenian: Starejši (stari ≥ 65 let)
English: These exposure changes are not considered clinically significant.
Slovenian: Omenjene spremembe izpostavljenosti ne veljajo za klinično pomembne.
English: Do not take Spedra:
Slovenian: Ne jemljite zdravila Spedra:
English: Sanofi Winthrop Industrie 1, rue de la Vierge Ambares et Lagrave 33565 Carbon-Blanc-Cedex France
Slovenian: Sanofi Winthrop Industrie 1, rue de la Vierge Ambares et Lagrave 33565 Carbon-Blanc-Cedex Francija
English: However, data on subjects older than 70 years are limited.
Slovenian: Podatki o bolnikih, starejših od 70 let, pa so omejeni.
English: • If you have had a stroke or heart attack in the last 6 months
Slovenian: • če ste v zadnjih 6 mesecih doživeli možgansko ali srčno kap;
English: You may feel dizzy (especially when standing), have a headache or feel your heart beating in your chest (palpitations).
Slovenian: Lahko postanete omotični (zlasti, če stojite), dobite glavobol ali občutite razbijanje srca v prsnem košu (palpitacije).
English: Use in patients using other medicinal products
Slovenian: Uporaba pri bolnikih, ki uporabljajo druga zdravila
English: • sudden decrease or loss of hearing (sometimes you may also feel dizzy or have ringing in your ears).
Slovenian: • nenadno poslabšanje ali izguba sluha (včasih se lahko pojavi tudi omotičnost ali zvonjenje v ušesih).
English: Spedra is a treatment for adult men suffering from erectile dysfunction (also known as impotence).
Slovenian: Spedra je zdravilo za odrasle moške, ki trpijo za erektilno disfunkcijo (znano tudi kot impotenca).
English: Potential for pharmacodynamic interactions with avanafil Nitrates
Slovenian: Potencial za farmakodinamične interakcije z avanafilom Nitrati
English: In addition, a subset of patients was enrolled into an open-label extension trial with 493 patients receiving avanafil for at least 6 months and 153 patients for at least 12 months.
Slovenian: Podskupina bolnikov je bila vključena tudi v odprto podaljšano študijo, v kateri je 493 bolnikov prejemalo avanafil najmanj 6 mesecev, 153 bolnikov pa najmanj 12 mesecev.
English: Problems with your sight or hearing
Slovenian: Težave z vidom ali sluhom
English: Spedra with drink and alcohol
Slovenian: Zdravilo Spedra skupaj s pijačo in alkoholom
English: Patients who experience erections lasting 4 hours or more (priapism) should be instructed to seek immediate medical assistance.
Slovenian: Bolniki, pri katerih se pojavi erekcija, ki traja 4 ure ali več (priapizem), morajo takoj poiskati zdravniško pomoč.
English: • If you have low blood pressure or high blood pressure not controlled by medicines
Slovenian: • če imate nizek ali visok krvni tlak, ki kljub zdravilom ni ustrezno nadzorovan;
English: The safety profile of Spedra is based on 2,566 subjects exposed to avanafil during the clinical development program.
Slovenian: Varnostni profil zdravila Spedra temelji na podatkih 2.566 posameznikov, ki so bili izpostavljeni avanafilu med programom kliničnega razvoja zdravila.
English: • carbamazepine - for epilepsy, to stabilise your mood or for certain types of pain
Slovenian: • karbamazepin - za epilepsijo, za stabilizacijo razpoloženja ali za določeno vrsto bolečin;
English: Its pharmacokinetics are dose-proportional over the recommended dose range.
Slovenian: Njegova farmakokinetika je sorazmerna odmerku v priporočenem razponu.
English: There was no evidence of favourable clinical effect of the combination in the population studied.
Slovenian: Ni bilo dokazov, da ima kombinacija koristni kliničen učinek v preučevani populaciji.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 June 2013
Slovenian: Datum prve odobritve: 21. junij 2013 Datum zadnjega podaljšanja:
English: The concomitant use of avanafil and a CYP inducer is not recommended as it may decrease the efficacy of avanafil.
Slovenian: Sočasna uporaba avanafila in induktorjev CYP ni priporočljiva, saj bi lahko zmanjšala učinkovitost avanafila.
English: Avanafil has no effect in the absence of sexual stimulation.
Slovenian: Avanafil nima nobenega učinka brez spolne stimulacije.
English: Haemodynamic interactions with doxazosin and tamsulosin were studied in healthy subjects in a twoperiod crossover-design trial.
Slovenian: Hemodinamske interakcije z doksazosinom in tamsulozinom so preučevali pri zdravih osebah v navzkrižnem preskušanju z dvema obdobjema.
English: Stop taking Spedra and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Slovenian: Prenehajte jemati zdravilo Spedra in takoj obiščite zdravnika, če opazite katerega koli od naslednjih resnih neželenih učinkov - morda boste potrebovali nujno zdravniško pomoč:
English: Avanafil has a terminal half-life of approximately 6-17 hours.
Slovenian: Končni razpolovni čas avanafila je približno 6-17 ur.
English: • If you have heart trouble.
Slovenian: • če imate težave s srcem.
English: Its effect is more potent on PDE5 than on other known phosphodiesterases (> 100-fold for PDE6; > 1,000-fold for PDE4, PDE8 and PDE10; > 5,000-fold for PDE2 and PDE7; > 10,000-fold for PDE1, PDE3, PDE9, and PDE11).
Slovenian: Njegov učinek na PDE5 je močnejši od učinka na druge znane fosfodiesteraze (> 100-krat za PDE6; > 1.000-krat za PDE4, PDE8 in PDE10; > 5.000-krat za PDE2 in PDE7; > 10.000-krat za PDE1, PDE3, PDE9 in PDE11).
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition, or postnatal development (see section 5.3).
Slovenian: Študije na živalih ne kažejo na posredne ali neposredne škodljive vplive na nosečnost, razvoj zarodka/ploda, porod ali postnatalni razvoj (glejte poglavje 5.3).
English: Physicians should also advise patients on what to do in the event of postural hypotensive symptoms.
Slovenian: Zdravniki naj bolnikom svetujejo tudi, kako ravnati v primeru simptomov posturalne hipotenzije.
English: Based on these data avanafil is not anticipated to have a significant effect on other medicinal products metabolised by these enzymes.
Slovenian: Glede na te podatke ni pričakovati, da bi imel avanafil bistven učinek na druga zdravila, ki se presnavljajo s temi encimi.
English: You may get more side effects than usual and they may be worse.
Slovenian: Lahko se namreč pojavi več neželenih učinkov kot običajno, ki utegnejo biti resne narave.
English: Patients should be informed not to take Spedra in such combinations.
Slovenian: Bolnike je treba opozoriti, naj ne jemljejo zdravila Spedra v takih kombinacijah.
English: It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Slovenian: Spada v skupino zdravil, imenovanih zaviralci fosfodiesteraze tipa 5 (PDE5).
English: You and your partner will still need to use foreplay to get ready for sex - just as you would if you were not taking a medicine to help you.
Slovenian: S partnerico ali partnerjem se morate še vedno na spolni odnos pripraviti s predigro - enako, kot bi to storili, če ne bi uporabili tega zdravila.
English: Spedra has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Spedra ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Older patients (65 years or over) had comparable exposure to that seen in younger patients (18-45 years).
Slovenian: Pri starejših bolnikih (starih 65 let ali več) so zabeležili podobno izpostavljenost kot pri mlajših bolnikih (starih od 18-45 let).
English: The table below lists the adverse reactions observed in placebo-controlled clinical trials according to the MedDRA frequency convention: 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), very rare (< 1/10,000) and not known (cannot be estimated from available data).
Slovenian: V spodnji tabeli so navedeni neželeni učinki, ki so jih opazili v kliničnih preskušanjih, nadzorovanih s placebom, razvrščeni glede na navedbo pogostnosti po MedDRA: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: What Spedra is and what it is used for
Slovenian: Kaj je zdravilo Spedra in za kaj ga uporabljamo
English: Populations not studied
Slovenian: Skupine bolnikov, ki jih niso preučevali
English: The European Medicines Agency has waived the obligation to submit the results of studies with Spedra in all subsets of the paediatric population in erectile dysfunction (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Spedra za vse podskupine pediatrične populacije z erektilno disfunkcijo (glejte poglavje 4.2 za informacije o pediatrični uporabi).
English: Other medicines and Spedra
Slovenian: Druga zdravila in zdravilo Spedra
English: If you are taking riociguat or are unsure tell your doctor.
Slovenian: Če jemljete riociguat ali ste negotovi, se posvetujte z zdravnikom.
English: The impact of avanafil on other transporters is unknown.
Slovenian: Vpliv avanafila na druge prenašalce ni znan.
English: The small changes in avanafil Cmax are considered to be of minimal clinical significance.
Slovenian: Majhne spremembe Cmax avanafila naj bi imele majhen kliničen pomen.
English: PHARMACEUTICAL FORM AND CONTENTS 4x1 tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 4x1 tableta
English: It may be risky for you to have sexual intercourse
Slovenian: Spolni odnosi so za vas lahko tvegani;
English: • abnormal extra sound from the heart
Slovenian: • nenormalni dodatni zvoki srca
English: Also some other medicines can affect the way Spedra works.
Slovenian: Prav tako lahko nekatera druga zdravila vplivajo na način delovanja zdravila Spedra.
English: In the long term clinical study, the percentage of patients who experienced adverse reactions decreased with increasing length of exposure.
Slovenian: V dolgoročni klinični študiji je odstotek bolnikov, pri katerih so se pojavile neželeni učinki, upadal s podaljševanjem časa izpostavljenosti zdravilu.
English: In both cohorts, one subject experienced a decrease in blood pressure without symptoms of hypotension, which resolved within 1 hour of onset.
Slovenian: V obeh kohortah so pri eni osebi zabeležili znižanje krvnega tlaka brez simptomov hipotenzije, ki je trajalo 1 uro.
English: Patients with severe hepatic impairment (Child-Pugh C).
Slovenian: Bolniki s hudo okvaro jeter (Child-Pugh C).
English: Studies in vitro have shown that avanafil is highly selective for PDE5.
Slovenian: Študije in vitro so pokazale, da je avanafil zelo selektiven za PDE5.
English: • If certain serious eye problems run in your family (such as retinitis pigmentosa).
Slovenian: • če imate v družinski anamnezi resne težave z očmi (na primer retinitis pigmentosa);
English: • influenza-like illness
Slovenian: • gripi podobna bolezen
English: Therefore, avanafil should be administered to such patients only after careful benefit-risk assessment.
Slovenian: Zato se avanafil pri teh bolnikih lahko uporabi šele po natančni oceni razmerja med tveganji in koristmi.
English: • phenobarbital or primidone - for epilepsy
Slovenian: • fenobarbital ali primidon - za epilepsijo;
English: • feeling sleepy or very tired
Slovenian: • zaspanost ali velika utrujenost
English: In clinical trials, avanafil was assessed for its effect on the ability of men with erectile dysfunction (ED) to achieve and maintain an erection sufficient for satisfactory sexual activity.
Slovenian: V kliničnih preskušanjih so ocenjevali učinek avanafila na zmožnost moških z erektilno disfunkcijo (ED), da dosežejo in ohranijo erekcijo, ki zadostuje za zadovoljiv spolni odnos.
English: It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors.
Slovenian: Ali so ti dogodki povezani neposredno z uporabo zaviralcev PDE5 ali z drugimi dejavniki, ni mogoče ugotoviti.
English: In a patient who has taken avanafil within 12 hours, where nitrate administration is deemed medically necessary in a lifethreatening situation, the likelihood of a significant and potentially dangerous drop in blood pressure is increased.
Slovenian: Pri bolniku, ki je vzel avanafil v zadnjih 12 urah in pri katerem je iz zdravstvenih razlogov v življenjsko nevarni situaciji nujna uporaba nitrata, obstaja večje tveganje za znaten in potencialno nevaren padec krvnega tlaka.
English: At clinically relevant concentrations avanafil is not an inhibitor of OATP1B1, OATP1B3, OCT1, OCT2, OAT1, OAT3 and BSEP.
Slovenian: V klinično pomembnih koncentracijah avanafil ni inhibitor OATP1B1, OATP1B3, OCT1, OCT2, OAT1, OAT3 in BSEP.
English: • congestion in the nose, sinuses or upper part of the airway bringing air into the lungs
Slovenian: • neprehodnost nosu, sinusov ali zgornjega dela dihalnih poti, ki vodijo v pljuča
English: This is thought to result from the combined effects of nitrates and avanafil on the nitric oxide/cGMP pathway.
Slovenian: Domnevno naj bi bila to posledica sestavljenega učinka nitratov in avanafila na pot dušikovega oksida/cGMP.
English: • pain in the lower back or side of lower chest
Slovenian: • bolečina v spodnjem delu hrbta ali pri strani spodnjega dela prsnega koša
English: • feeling strange
Slovenian: • čudni občutki
English: Do not use Spedra together with other treatments for erectile dysfunction such as sildenafil, tadalafil or vardenafil.
Slovenian: Ne uporabljajte zdravila Spedra skupaj z drugimi zdravili za erektilno disfunkcijo, kot so sildenafil, tadalafil in vardenafil.
English: What you need to know before you take Spedra
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Spedra
English: In the rabbit study, maternal toxicity was observed at 240 mg/kg/day.
Slovenian: V študiji pri kuncih so opazili maternalno toksičnost pri odmerku 240 mg/kg/dan.
English: Patients should be advised to stop taking PDE5 inhibitors, including avanafil, and seek prompt medical attention in the event of sudden decrease or loss of hearing.
Slovenian: Bolnike je treba opozoriti, da morajo prenehati jemati zaviralce PDE5, vključno z avanafilom, in takoj poiskati zdravniško pomoč, če opazijo nenadno poslabšanje ali izgubo sluha.
English: Other treatments for erectile dysfunction
Slovenian: Druga zdravila za erektilno disfunkcijo
English: • The active substance is avanafil.
Slovenian: • Zdravilna učinkovina je avanafil.
English: Based on in vitro data, at clinically relevant concentrations avanafil could be an inhibitor of BCRP.
Slovenian: Na podlagi in vitro podatkov bi lahko avanafil, v klinično pomembnih koncentracijah, bil inhibitor BCRP.
English: Remember that Spedra will only help you to get an erection if you are sexually stimulated.
Slovenian: Pomnite, da vam bo zdravilo Spedra pomagalo do erekcije le, če boste spolno stimulirani.
English: Some men taking medicines like Spedra have had problems with their sight and hearing - see “Serious side effects” in section 4 for more details.
Slovenian: Nekateri moški, ki jemljejo zdravila, podobna zdravilu Spedra, so poročali o težavah z vidom in sluhom - za več podrobnosti glejte „Resni neželeni učinki“ v poglavju 4.
English: Pregnancy Spedra is not indicated for use in women.
Slovenian: Nosečnost Zdravilo Spedra ni indicirano za uporabo pri ženskah.
English: Patients should be advised to avoid grapefruit juice within 24 hours prior to taking avanafil.
Slovenian: Bolnike je treba opozoriti, naj se 24 ur pred jemanjem avanafila izogibajo uživanju grenivkinega soka.
English: The recommended dose is 100 mg taken as needed approximately 15 to 30 minutes before sexual activity (see section 5.1).
Slovenian: Priporočeni odmerek je 100 mg, ki se ga jemlje po potrebi približno 15 do 30 minut pred spolnim odnosom (glejte poglavje 5.1).
English: Avanafil is > 100-fold more potent for PDE5 than PDE6, which is found in the retina and is responsible for phototransduction.
Slovenian: Avanafil je > 100-krat močnejši za PDE5 kot za PDE6, ki ga najdemo v mrežnici in je odgovoren za prevajanje svetlobnih dražljajev.
English: This is because Spedra can affect the way some other medicines work.
Slovenian: Zdravilo Spedra namreč lahko vpliva na način delovanja drugih zdravil.
English: Spedra will not help you if you do not have erectile dysfunction.
Slovenian: Zdravilo Spedra vam ne bo pomagalo, če nimate erektilne disfunkcije.
English: This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection.
Slovenian: To povzroči sprostitev gladkih mišic in omogoči dotok krvi v tkiva penisa, čemur sledi erekcija.
English: The recommended dose is a 100 mg tablet, as needed.
Slovenian: Priporočeni odmerek je ena tableta 100 mg po potrebi.
English: If you take more Spedra than you should
Slovenian: Če ste vzeli večji odmerek zdravila Spedra, kot bi smeli
English: • so called “alpha-blockers” - for prostate problems or for lowering your high blood pressure
Slovenian: • tako imenovane „zaviralce receptorjev alfa“ - za težave s prostato ali za znižanje visokega krvnega tlaka;
English: • feeling your heartbeat in your chest (palpitations)
Slovenian: • razbijanje srca v prsnem košu (palpitacije)
English: The most common adverse reactions reported in clinical studies were headache, flushing, nasal and sinus congestion and back pain.
Slovenian: Najpogostejši neželeni učinki, o katerih so poročali v kliničnih študijah, so bili glavobol, zardevanje, zamašen nos in sinusi ter bolečine v hrbtu.
English: Менарини България” ЕООД тел.
Slovenian: Менарини България” ЕООД