FrancophonIA/ELRC3.0 huggingface dataset:
English: This summary was last updated in 07-2014.
Croatian: Sažetak je posljednji put ažuriran 07.2014.
English: It is available as capsules (250 mg) and as an oral solution.
Croatian: Dostupan je kao kapsule (250 mg) i kao oralna otopina.
English: The full EPAR for Aptivus can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Aptivus nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The dose of the oral solution depends on body surface area (calculated using the child's height and weight).
Croatian: Doza oralne otopine ovisi o tjelesnoj površini (izračunato pomoću visine i težine djeteta).
English: In patients aged 12 years and above, the recommended dose of Aptivus is 500 mg (two capsules) twice a day.
Croatian: U bolesnika u dobi od 12 godina i starijih preporučena doza lijeka Aptivus iznosi 500 mg (dvije kapsule) dva puta na dan.
English: Each dose of Aptivus must be taken with ritonavir and food.
Croatian: Svaka doza lijeka Aptivus mora se uzeti s ritonavirom i hranom.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aptivus on 25 October 2005.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Aptivus vrijedi na prostoru Europske unije od 25. listopada 2005.
English: What measures are being taken to ensure the safe and effective use of Aptivus?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Aptivus?
English: When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection.
Croatian: Prilikom inhibiranja enzima, virus se ne reproducira normalno. čime se usporava širenje infekcije.
English: This allows a lower dose of tipranavir to be used for the same antiviral effect.
Croatian: Ovo omogućuje korištenje manje doze tipranavira za isto antivirusno djelovanje.
English: Children aged between two and 12 years should use the oral solution.
Croatian: Djeca u dobi od dvije do 12 godina trebaju uzimati oralnu otopinu.
English: On average, it took 113 days for treatment to stop working in adults taking Aptivus.
Croatian: Prosječno je prošlo 113 dana kako bi terapija prestala djelovati u odraslih osoba koje su uzimale Aptivus.
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 Aptivus.
Croatian: Objašnjava kako je Odbor za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Aptivus.
English: A ‘response' was defined as a fall in the levels of HIV in the blood (viral load) by 90% or more that was maintained until the end of the 48 weeks.
Croatian: „Odgovor” je definiran kao snižavanje razina HIV-a u krvi (virusnu opterećenje) za 90% ili više, a koje je održano sve do kraja 48. tjedna.
English: Similar side effects were seen in children and adolescents, although vomiting, rash and pyrexia (fever) were seen more commonly than in adults.
Croatian: Slične nuspojave uočene su i u djece i adolescenata, iako su povraćanje, osip i pireksija (groznica) češće uočeni u odraslih osoba.
English: This was compared with an average of zero days in those taking the comparator, meaning that most of the patients taking the comparator did not respond to their treatment at all.
Croatian: Ovo je uspoređeno s prosječno nula dana u osoba koje su uzimale komparatorski lijek, što znači da većina bolesnika koja je uzimala komparator nije uopće odgovorila na terapiju.
English: All of the patients started treatment with the oral solution, but adolescents taking the full adult dose could switch to the capsules after four weeks.
Croatian: Svi su bolesnici započeli liječenje oralnom otopinom, no adolescenti koji su uzimali cijelu dozu za odrasle osobe morali su preći na kapsule nakon četiri tjedna.
English: Aptivus has also been studied in one study involving 63 children aged between two and 12 years, and 52 adolescents aged between 12 and 18 years, almost all of whom had taken HIV treatments in the past.
Croatian: Aptivus se također ispitivao u jednom ispitivanju koje je obuhvatilo 63 djece u dobi između dvije i 12 godina, i 52 adolescenta u dobi između 12 i 18 godina, pri čemu su skoro svi u prošlosti uzimali terapiju protiv HIV-a.
English: Aptivus does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Aptivus ne liječe infekcije HIV-a ili SIDA-u, no može odgoditi oštećenje imunosnog sustava i razvoj infekcija i bolesti povezane sa SIDA-om.
English: The main measures of effectiveness were the number of patients who responded to treatment, and how long it took before treatment stopped working, during the first 48 weeks of treatment.
Croatian: Glavna mjera djelotvornosti bio je broj bolesnika koji su odgovorili na liječenje te trajanje razdoblja djelovanja liječenja tijekom prvih 48 tjedana liječenja.
English: Aptivus should only be used in patients who have no other treatment options.
Croatian: Aptivus treba koristiti samo u bolesnika koji nemaju drugih mogućnosti liječenja.
English: Ritonavir is another protease inhibitor that is used as a ‘booster'.
Croatian: Ritonavir je drugi inhibitor proteaze koji se koristi kao „booster”.
English: In the study of children and adolescents, 31% of the adolescents taking the capsules (9 out of 29) and 50% of the children taking the oral solution (31 out of 62) had reached and maintained viral loads below 400 copies/ml after 48 weeks.
Croatian: U ispitivanju provedenom u djece i adolescenata, 31% adolescenata koji su uzimali kapsule (9 od 29) i 50% djece koje su uzimali oralnu otopinu (31 od 62) dosegnuli su i zadržali su virusna opterećenja u razini do 400 kopija/ml nakon 48 tjedana.
English: A risk management plan has been developed to ensure that Aptivus is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Aptivus.
English: In the two adult studies taken together, 34% of the patients taking Aptivus (251 out of 746) responded to treatment, compared with 16% of the patients taking the comparator protease inhibitors (113 out of 737).
Croatian: U dva ispitivanja provedena u odraslih osoba, 34% bolesnika koji su uzimali Aptivus (251 od 746) odgovorilo je na liječenje, u usporedbi sa 16% bolesnika koji su uzimali komparatorske inhibitore proteaze (113 od 737).
English: This document is a summary of the European public assessment report (EPAR) for Aptivus.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Aptivus.
English: Treatment with Aptivus should be started by a doctor who has experience in the treatment of HIV-1 infection.
Croatian: Liječenje lijekom Aptivus mora započeti liječnik s iskustvom u liječenju infekcija HIV-1.
English: • medicines that are broken down in the same way as Aptivus or ritonavir and are harmful at high levels in the blood.
Croatian: • lijekove koji se razgrađuju na isti način kao Aptivus ili ritonavir te su štetni u slučaju visokih koncentracija u krvi.
English: Aptivus is used to treat patients aged two years and above who have human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Aptivus se koristi za liječenje bolesnika u dobi od dvije godine i starijih zaraženih virusom humane imunodeficijencije tip 1 (HIV-1), virusom koji uzrokuje sindrom stečene imunodeficijencije (SIDA).
English: Other information about Aptivus:
Croatian: Ostale informacije o lijeku Aptivus
English: Aptivus capsules have been studied in two main studies involving a total of 1,483 adults who had received many different HIV-medicines in the past, and were not responding to their current treatment combination including a protease inhibitor.
Croatian: Kapsule lijeka Aptivus ispitane su u dva glavna ispitivanja, koja su obuhvatila ukupno 1.483 odraslih osoba koje su u prošlosti primile mnogo različitih lijekova protiv HIV-a, te nisu odgovarali na svoju trenutnu terapijsku kombinaciju uključujući i inhibitor proteaze.
English: Although the Committee had some concerns over how the study in children and adolescents was designed, the Committee noted that its results supported the use of the capsules in adolescents and the oral solution in children between the ages of two and 12 years.
Croatian: Iako je Odbor imao određene razloge za zabrinutost vezanu uz dizajn ispitivanja provedenog u djece i odraslih, Odbor je napomenuo da rezultati podržavaju primjenu kapsula u adolescenata te oralne otopine u djece u starosti između dvije i 12 godina.
English: However, the available information does not support the use of the oral solution in patients aged 12 years or above.
Croatian: No, dostupne informacije ne podržavaju primjenu oralne otopine u bolesnika u dobi od 12 godina ili starijih.
English: For more information about treatment with Aptivus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Aptivus pročitajte u uputama o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: Aptivus capsules, taken in combination with ritonavir, were more effective than the comparator medicines in patients with few remaining options for successful HIV treatment.
Croatian: Kapsule Aptivus, u kombinaciji s ritonavirom, bile su djelotvornije od komparatorskih lijekova u bolesnika s nekoliko preostalih mogućnosti za uspješnu terapiju HIV-a.
English: In all three studies, the patients also took ritonavir and a combination of other HIV-medicines that were chosen as they had the best chances of reducing the levels of HIV in their blood.
Croatian: U sva tri ispitivanja, bolesnici su također uzimali ritonavir i kombinaciju drugog lijeka protiv HIV-a koji su bili odabrani budući da su imali najbolje izglede za snižavanje koncentracije HIV-a u svojoj krvi.
English: However, it concluded that the medicine should only be considered for use as ‘last line' therapy, when no other protease inhibitors are predicted to work.
Croatian: No, zaključilo je da lijek treba smatrati „zadnjom linijom” terapije, u slučajevima kada drugi inhibitori proteaze ne djeluju.
English: Both studies compared the effects of Aptivus with those of another protease inhibitor that was chosen on the basis of the patient's previous treatments and predicted response.
Croatian: Oba su ispitivanja usporedila djelovanje lijeka Aptivus s djelovanjem drugih inhibitora proteaze koji su odabrani na temelju prethodnog liječenja bolesnika i predviđenog odgovora.
English: Aptivus with ritonavir must not be used in patients with moderate or severe problems with their liver or who are taking any of the following medicines:
Croatian: Aptivus s ritonavirom ne smije se koristiti u bolesnika s umjerenim do ozbiljnim problemima s jetrom ili osobama koje uzimaju bilo koji od sljedećih lijekova:
English: The study looked at the safety and effectiveness of Aptivus, and at the levels of the medicine in the patients' blood.
Croatian: Ispitivanje je istražilo sigurnost i djelotvornost lijeka Aptivus te koncentracije lijeka u krvi bolesnika.
English: The CHMP noted that the studies supported the use of Aptivus capsules in adults.
Croatian: CHMP je zaključio da ispitivanja podržavaju primjenu kapsula Aptivus u odraslih osoba.
English: Therefore, the CHMP decided that the benefits of Aptivus capsules are greater than their risks for the treatment of adults and adolescents 12 years of age or older.
Croatian: Stoga, CHMP je odlučio da su koristi kapsula Aptivus veće od njihovog rizika za liječenje odraslih osoba i adolescenata u dobi od 12 godina ili starijih.
English: The Committee recommended that Aptivus be given marketing authorisation.
Croatian: Odbor je preporučio da se za lijek Aptivus izda odobrenje za stavljanje lijeka u promet.
English: Aptivus is a medicine that contains the active substance tipranavir.
Croatian: Aptivus je lijek koji sadrži djelatnu tvar tipranavir.
English: It is used in patients who have already been treated with other antiviral medicines for HIV infection, and in whom many other medicines in the same class as Aptivus (protease inhibitors) do not work.
Croatian: Koristi se samo u bolesnika čija je infekcija HIV-om već liječena drugim lijekovima, te u kojih mnogi drugi lijekovi iz iste kategorije kao i Aptivus (inhibitori proteaze) nisu polučili rezultate.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aptivus, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku, za lijek Aptivus uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju primjenjivati.
English: The active substance in Aptivus, tipranavir, is a protease inhibitor.
Croatian: Djelatna tvar u lijeku Aptivus, tipranavir, je inhibitor proteaze.
English: What is the risk associated with Aptivus?
Croatian: Koji su rizici povezani s lijekom Aptivus?
English: Aptivus, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Croatian: Aptivus, koji se uzima u kombinaciji s drugim lijekovima protiv HIV-a, snižava količinu HIV-a u krvi i pomaže pri održavanju niske razine.
English: Doctors should only prescribe Aptivus once they have looked at the HIV-medicines that the patient has taken before and the likelihood that the virus will respond to the medicine.
Croatian: Liječnici trebaju propisivati Aptivus nakon što su provjerili koje je lijekove protiv HIV-a uzimao bolesnik ranije te izglednost da će virus reagirati na lijek.
English: Aptivus with ritonavir must not be used with colchicine (a medicine used to treat gout) in patients with kidney or liver impairment.
Croatian: Aptivus s ritonavirom mora se koristiti s kolhicinom (lijekom koji se koristi za liječenje gihta) u bolesnika s oštećenjem bubrega ili jetre.
English: In adults, the most common side effects when taking Aptivus with ritonavir (seen in more than 1 patient in 10) are diarrhoea and nausea (feeling sick).
Croatian: U odraslih osoba najčešće nuspojave prilikom uzimanja lijeka Aptivus s ritonavirom (kod više od 1 na 10 osoba) su proljev i mučnina (osjećaj slabosti).
English: It slows down the rate at which tipranavir is broken down, increasing the levels of tipranavir in the blood.
Croatian: Usporava brzinu razgradnje tipranavira, te tako povisuje koncentraciju tipranavira u krvi.
English: The Committee also decided that the benefits of Aptivus oral solution are greater than its risks for children from two to 12 years of age.
Croatian: Odbor je također zaključio da su koristi oralne otopine lijeka Aptivus veće od rizika za djecu u dobi od dvije do 12 godina.
English: Aptivus is used in combination with low-dose ritonavir (another HIV-medicine) and other HIV-medicines.
Croatian: Aptivus se koristi u kombinaciji s ritonavirom male doze (drugi lijek za liječenje HIV-a) i drugim lijekovima za liječenje HIV-a.
English: What benefit has Aptivus shown during the studies?
Croatian: Koje su koristi lijeka Aptivus dokazane u ispitivanjima?
English: • St John's wort (a herbal preparation used to treat depression);
Croatian: • Gospinu travu (biljni pripravak za liječenje depresije);
English: What is Aptivus?
Croatian: Što je Aptivus?
English: It blocks an enzyme called protease that is involved in the reproduction of HIV.
Croatian: Inhibira enzime proteaze koji su uključeni u reprodukciju HIV-a.
English: See the package leaflet for the full list of these medicines.
Croatian: Potpuni popis ovih lijekova potražite u uputi o lijeku.
English: Why has Aptivus been approved?
Croatian: Zašto je lijek Aptivus odobren?
English: For the full list of all side effects reported with Aptivus, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Aptivus, potražite u uputi o lijeku.
English: How has Aptivus been studied?
Croatian: Kako se Aptivus ispitivao?
English: What is Aptivus used for?
Croatian: Za što se Aptivus koristi?
English: How is Aptivus used?
Croatian: Kako se Aptivus koristi?
English: Adult females (including elderly)
Croatian: Odrasle žene (uključujući starije)
English: Co. Galway IRELAND
Croatian: Galway IRSKA
English: You must not use Fulvestrant Mylan if you are pregnant.
Croatian: Ne smijete koristiti Fulvestrant Mylan ako ste trudni.
English: The safety and efficacy of fulvestrant in children from birth to 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost fulvestranta u djece u dobi od rođenja do 18 godina nisu još ustanovljene.
English: Children and adolescents Fulvestrant Mylan is not indicated in children and adolescents under 18 years.
Croatian: Djeca i adolescenti Fulvestrant Mylan nije namijenjen za primjenu u djece i adolescenata mlađih od 18 godina.
English: For each of the two syringes:
Croatian: Učinci na kosti
English: Pharmacotherapeutic group: Endocrine therapy, anti-estrogens, ATC code: L02BA03
Croatian: Farmakoterapijska skupina: endokrina terapija, antiestrogeni, ATK oznaka: L02BA03
English: Patients with a best objective response of complete response, partial response or stable disease ≥24 weeks.
Croatian: e Bolesnice s najboljim objektivnim odgovorom na terapiju u kompletnom odgovoru, djelomičnom odgovoru i stabilnoj bolesti tijekom ≥24 tjedna.
English: 7.4 (3.9, NE)
Croatian: 7,4 (3,9; NP)
English: The median time to death was 27.4 months for patients treated with fulvestrant and 27.6 months for patients treated with anastrozole.
Croatian: Medijan vremena do smrti iznosio je 27,4 mjeseca za bolesnice liječene fulvestrantom, a 27,6 mjeseci za bolesnice liječene anastrozolom.
English: Identified metabolites (includes 17-ketone, sulphone, 3-sulphate, 3- and 17-glucuronide metabolites) are either less active or exhibit similar activity to fulvestrant in anti-estrogen models.
Croatian: Poznati metaboliti (obuhvaćaju 17-keton, sulfon, 3-sulfat, 3- i 17-glukuronid metabolite) manje su aktivni ili pokazuju aktivnost sličnu fulvestrantu u antiestrogenskim modelima.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08 january 2018
Croatian: Datum prvog odobrenja: 08. siječanj 2018.
English: Do not use Fulvestrant Mylan: - if you are allergic to fulvestrant or to any of the other ingredients of this medicine (listed in section 6) - if you are pregnant or breast-feeding - if you have severe liver problems
Croatian: Nemojte primjenjivati Fulvestrant Mylan - ako ste alergični na fulvestrant ili neki drugi sastojak ovog lijeka (naveden u dijelu 6) - ako ste trudni ili dojite - ako imate teških tegoba s jetrom.
English: Fulvestrant is not recommended for use in children and adolescents as safety and efficacy have not been established in this group of patients (see section 5.1).
Croatian: Fulvestrant se ne preporučuje za primjenu u djece i adolescenata jer nisu ustanovljene sigurnost primjene i djelotvornost u toj dobnoj skupini (vidjeti dio 5.1).
English: OS is presented for the final survival analyses at 75 % maturity.
Croatian: Prikazano je OS za konačne analize preživljenja pri 75%-tnoj zrelosti podataka.
English: If you can become pregnant, you should use effective contraception while being treated with Fulvestrant Mylan.
Croatian: Ako biste mogli zatrudnjeti, morate primjenjivati učinkovitu kontracepciju dok se liječite lijekom Fulvestrant Mylan.
English: Keep the pre-filled syringe in the original package in order to protect from light.
Croatian: Napunjenu štrcaljku čuvati u originalnom pakiranju radi zaštite od svjetlosti.
English: There are no long-term data on the effect of fulvestrant on bone.
Croatian: Nema podataka o dugoročnom utjecaju fulvestranta na kosti.
English: Although the data collected were limited, the steady-state trough concentrations of fulvestrant in children appear to be consistent with those in adults.
Croatian: Iako su prikupljeni podaci bili ograničeni, čini se da su koncentracije fulvestranta u stanju dinamičke ravnoteže u djece u skladu s onima u odraslih.
English: Fulvestrant is contraindicated in pregnancy (see section 4.3).
Croatian: Fulvestrant je kontraindiciran tijekom trudnoće (vidjeti dio 4.3).
English: PFS:Progression-free survival; ORR:Objective response rate; OR:Objective response; CBR:Clinical benefit rate; CB:Clinical benefit; OS:Overall survival; K-M:Kaplan-Meier; CI:Confidence interval; AI:Aromatase inhibitor; AE:Anti-estrogen.
Croatian: PFS: preživljenje bez progresije bolesti; ORR: stopa objektivnog odgovora; OR: objektivni odgovor; CBR: stopa kliničke koristi; CB: klinička korist; OS: ukupno preživljenje; K-M: Kaplan-Meier; CI: interval pouzdanosti; AI: inhibitor aromataze; AE: antiestrogen.
English: The mechanism of action is associated with down-regulation of estrogen receptor protein levels.
Croatian: Mehanizam djelovanja povezan je sa snižavanjem razine proteina estrogenskih receptora.
English: Your healthcare professional will be responsible for the correct storage, use and disposal of Fulvestrant Mylan.
Croatian: Zdravstveni radnik bit će odgovoran za pravilno čuvanje, uporabu i zbrinjavanje lijeka Fulvestrant Mylan.
English: Overall, fulvestrant at the 250 mg monthly dose was at least as effective as anastrozole in terms of progression free survival, objective response, and time to death.
Croatian: Sveukupno je fulvestrant u mjesečnoj dozi od 250 mg bio barem jednako učinkovit kao anastrozol u smislu preživljenja bez progresije bolesti, objektivnog odgovora i vremena do smrti.
English: Fulvestrant Mylan is used either:
Croatian: Fulvestrant Mylan se koristi:
English: The median duration of fulvestrant 500 mg treatment across the pooled dataset (including the studies mentioned above plus FALCON) was 6.5 months.
Croatian: Medijan trajanja liječenja fulvestrantom u dozi od 500 mg u objedinjenom skupu podataka (koji uključuju podatke iz prethodno navedenih ispitivanja i ispitivanja FALCON), iznosio je 6,5 mjeseci.
English: Fulvestrant Mylan contains the active substance fulvestrant, which belongs to the group of estrogen blockers.
Croatian: Fulvestrant Mylan sadržava djelatnu tvar fulvestrant, koja pripada skupini blokatora estrogena.
English: Fulvestrant Mylan is not expected to affect your ability to drive or use machines.
Croatian: Ne očekuje se da bi Fulvestrant Mylan mogao utjecati na sposobnost vožnje i rada sa strojevima.
English: OR [% (95% CI)] TTR*, Median [months (range)]
Croatian: OR [% (95% CI)] TTR*, medijan [mjeseci (raspon)]
English: Fulvestrant is not indicated for use in children.
Croatian: Fulvestrant nije namijenjen za primjenu u djece.
English: In a population pharmacokinetic analysis of data from phase 3 studies, no difference in fulvestrant's pharmacokinetic profile was detected with regard to age (range 33 to 89 years), weight (40-127 kg) or race.
Croatian: U analizi podataka populacijske farmakokinetike iz ispitivanja faze 3, nisu otkrivene razlike u farmakokinetičkom profilu fulvestranta s obzirom na dob (raspon 33 do 89 godina), tjelesnu težinu (40 - 127 kg) ili rasu.
English: The efficacy and safety of fulvestrant (either as monotherapy or in combination with palbociclib) have not been studied in patients with critical visceral disease.
Croatian: Djelotvornost i sigurnost fulvestranta (bilo u monoterapiji ili u kombinaciji s palbociklibom) nisu se ispitivale u bolesnica s kritičnom visceralnom bolešću.
English: Manufacturer MYLAN TEORANTA Inverin
Croatian: Mylan Teoranta Inverin