FrancophonIA/ELRC3.0 huggingface dataset:
English: Route of Administration
Croatian: Administration
English: Immediate Packaging Content (concentration)
Croatian: Immediate Packaging Content
English: MA (EU) Number (Invented) name
Croatian: MA (EU) Number (Invented) Strength Pharmaceutical Route of
English: 20 vials
Croatian: 0.5 ml
English: Pack size multi-dose vial (glass)
Croatian: intramuskularna bočica s više doza (staklo) 0.5 ml
English: Single-dose prefilled syringe (glass) without needle
Croatian: 1 špric jednostrukom dozom šprica (staklo) bez igle _ _ 1 Cjelino cjepivo protiv virusa influence koje nije inaktivirano, inaktivirano, sadrži antigen od
English: Strength Pharmaceutical Form
Croatian: Form
English: 1 syringe
Croatian: (concentration)
English: Further information on Telzir can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Telzir.
Croatian: Više informacija o lijeku Telzir dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Telzir.
English: Telzir tablets can be taken with or without food.
Croatian: Tablete lijeka Telzir mogu se uzimati s hranom ili bez nje.
English: A similar benefit was also seen in one main study including 57 children aged between 2 and 18 years.
Croatian: Slična korist zabilježena je i u jednom glavnom ispitivanju kojim je bilo obuhvaćeno 57-ero djece u dobi od 2 do 18 godina.
English: This overview was last updated in 05-2019.
Croatian: Pregled informacija posljednji je put ažuriran u 5. 2019.
English: Similar side effects are seen in younger patients.
Croatian: Slične su nuspojave zabilježene i u mlađih bolesnika.
English: Telzir received a marketing authorisation valid throughout the EU on 12 July 2004.
Croatian: Lijek Telzir dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 12. srpnja 2004.
English: Other information about Telzir:
Croatian: Ostale informacije o lijeku Telzir:
English: In adults, each dose of Telzir must be given with 100 mg ritonavir, twice a day.
Croatian: Odrasle osobe moraju svaku dozu lijeka Telzir uzeti sa 100 mg ritonavira, dvaput dnevno.
English: What is Telzir and what is it used for?
Croatian: Što je Telzir i za što se koristi?
English: When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection.
Croatian: Kada je taj enzim blokiran, virus se ne razmnožava normalno, što usporava širenje infekcije.
English: Telzir is available as tablets (700 mg) and as an oral suspension (50 mg/ml) to be taken by mouth.
Croatian: Lijek Telzir dostupan je u obliku tableta (700 mg) i kao oralna suspenzija (50 mg/ml) i uzima se kroz usta.
English: What measures are being taken to ensure the safe and effective use of Telzir?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Telzir?
English: It contains the active substance fosamprenavir.
Croatian: Sadrži djelatnu tvar fosamprenavir.
English: There is no recommended dose for patients below 18 years who weigh less than 25 kg.
Croatian: Nema preporučene doze za bolesnike mlađe od 18 godina koji teže manje od 25 kg.
English: Telzir has been studied in three main studies involving 1,862 adults.
Croatian: Lijek Telzir ispitivan je u tri glavna ispitivanja kojima su bile obuhvaćene 1 862 odrasle osobe.
English: It slows down the rate at which amprenavir is broken down, helping to increase levels of amprenavir in the blood.
Croatian: On usporava brzinu razgradnje amprenavira i tako pomaže pri povišenju razine amprenavira u krvi.
English: Telzir does not cure HIV infection or AIDS, but it can hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Lijekom Telzir ne liječi se infekcija HIV-om niti AIDS, no može se odgoditi oštećenje imunosnog sustava i nastanak infekcija i bolesti povezanih s AIDS-om.
English: An overview of Telzir and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Telzir i zašto je odobren u EU-u
English: Side effects reported with Telzir are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Telzir pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Treatment with Telzir should be started by a doctor who has experience in the management of HIV infection.
Croatian: Terapiju lijekom Telzir mora započeti liječnik s iskustvom u liječenju infekcije HIV-om.
English: In one study, after 48 weeks of treatment, 69% of previously untreated adults taking ritonavir-boosted Telzir (221 out of 322) and 68% of those taking nelfinavir (221 out of 327) had viral loads below 400 copies/ml (considered a low viral load).
Croatian: U jednom ispitivanju, nakon 48 tjedana liječenja u 69 % odraslih osoba koje prethodno nisu bile liječene i koje su primale Telzir pojačan ritonavirom (221 od 322) te u 68 % onih koje su primale nelfinavir (221 od 327) virusno je opterećenje iznosilo manje od 400 kopija/ml (što se smatra niskim virusnim opterećenjem).
English: The oral suspension should be taken without food in adults, but in younger patients it should be taken with food in order to hide the taste and help them stick to treatment.
Croatian: Odrasle osobe trebaju oralnu suspenziju uzimati bez hrane, ali mlađi bolesnici trebaju je uzimati s hranom kako bi se prikrio njezin okus i na taj način pomoglo bolesnicima da nastave uzimati lijek.
English: As Telzir is converted into amprenavir in the body, it must not be given at the same time as other medicines containing amprenavir.
Croatian: Budući da se Telzir u organizmu pretvara u amprenavir, ne smije se davati istodobno s drugim lijekovima koji sadrže amprenavir.
English: Telzir must not be used in patients who are taking lurasidone (for schizophrenia and bipolar disorder), paritaprevir (for hepatitis C), simvastatin or lovastatin (for lowering blood cholesterol), rifampicin (for tuberculosis), St John's wort (a herbal preparation for depression and anxiety), or certain medicines that are broken down in the same way as Telzir or ritonavir as Telzir may affect their blood levels.
Croatian: Telzir se ne smije davati ni bolesnicima koji uzimaju lurasidon (za liječenje shizofrenije i bipolarnog poremećaja), paritaprevir (za liječenje hepatitisa C), simvastatin ili lovastatin (za snižavanje kolesterola u krvi), rifampicin (za liječenje tuberkuloze), gospinu travu (biljni pripravak protiv depresije i anksioznosti) ili određene lijekove koji se razgrađuju na isti način kao Telzir ili ritonavir jer Telzir može utjecati na njihovu razinu u krvi.
English: Telzir is an antiviral medicine for treating patients aged 6 years or above who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Telzir je protuvirusni lijek koji se koristi za liječenje bolesnika u dobi od šest godina i starijih koji su zaraženi virusom humane imunodeficijencije tipa 1 (HIV-1), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: However, there were too few patients aged below 6 years to support the use of Telzir in this age group.
Croatian: Međutim, u tom je ispitivanju bilo premalo bolesnika mlađih od šest godina da bi ono moglo potkrijepiti primjenu lijeka Telzir u toj dobnoj skupini.
English: What are the risks associated with Telzir?
Croatian: Koji su rizici povezani s lijekom Telzir?
English: The recommended dose for adults (aged 18 years or over) and for patients aged between 6 and 18 years who weigh more than 39 kg is 700 mg twice a day.
Croatian: Preporučena doza za odrasle (u dobi od 18 godina i starije) te za bolesnike u dobi od 6 do 18 godina koji teže više od 39 kg iznosi 700 mg dvaput dnevno.
English: Why is Telzir authorised in the EU?
Croatian: Zašto je lijek Telzir odobren u EU-u?
English: As for all medicines, data on the use of Telzir are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Telzir kontinuirano se prate.
English: In a third study in patients who had been treated before, Telzir was less effective than the comparator medicine lopinavir, with patients taking lopinavir having larger reductions in viral loads over the first 48 weeks.
Croatian: U trećem ispitivanju u bolesnika koji su prethodno liječeni, lijek Telzir bio je manje učinkovit od usporednog lijeka lopinavira, pri čemu su bolesnici koji su uzimali lopinavir imali veće smanjenje virusnog opterećenja tijekom prvih 48 tjedana.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Telzir have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Telzir nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The European Medicines Agency concluded that Telzir, which contains a prodrug of amprenavir, is as effective as comparator medicines in reducing viral load.
Croatian: Europska agencija za lijekove zaključila je da je lijek Telzir, koji sadrži predlijek amprenavira, jednako učinkovit kao i usporedni lijekovi u pogledu smanjenja virusnog opterećenja.
English: For patients who have taken medicines to treat their HIV infection before and did not respond to that treatment, doctors should only prescribe Telzir once they have looked at the antiviral medicines the patient has taken before and assessed the likelihood of the virus's response to any new antiviral medicines that might be prescribed.
Croatian: Bolesnicima koji su prethodno uzimali lijekove za liječenje infekcije HIV-om i nisu odgovorili na terapiju liječnici smiju propisati lijek Telzir tek nakon što provjere koje je protuvirusne lijekove bolesnik prethodno uzimao i procijene vjerojatnost odgovora virusa na nove protuvirusne lijekove koji bi se mogli propisati.
English: Telzir should not be used in people who are hypersensitive (allergic) to fosamprenavir, amprenavir, any of the other ingredients, or ritonavir.
Croatian: Telzir se ne smije davati osobama koje su preosjetljive (alergične) na fosamprenavir, amprenavir, bilo koji drugi sastojak lijeka ili na ritonavir.
English: For more information about using Telzir, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Telzir pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: In younger patients, the dose of ritonavir depends on body weight.
Croatian: Doza ritonavira za mlađe bolesnike ovisi o njihovoj tjelesnoj težini.
English: In patients aged between 6 and 18 years who weigh between 25 and 39 kg, the dose depends on body weight.
Croatian: Doza za bolesnike u dobi od 6 do 18 godina koji teže između 25 i 39 kg ovisi o njihovoj tjelesnoj težini.
English: Telzir is used in combination with ritonavir and other HIV medicines.
Croatian: Telzir se primjenjuje u kombinaciji s ritonavirom i drugim lijekovima protiv HIV-a.
English: Telzir, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Croatian: Kad se uzima u kombinaciji s drugim protuvirusnim lijekovima, Telzir snižava koncentraciju HIV-a u krvi i održava je na niskoj razini.
English: The active substance in Telzir, fosamprenavir, is a ‘prodrug' of the protease inhibitor amprenavir, which means that it is converted into amprenavir in the body.
Croatian: Djelatna tvar lijeka Telzir, fosamprenavir, „predlijek” je amprenavira, inhibitora proteaze, što znači da se u tijelu pretvara u amprenavir.
English: Ritonavir, another protease inhibitor, is used with Telzir as a ‘booster'.
Croatian: Ritonavir, drugi inhibitor proteaze, primjenjuje se s lijekom Telzir kao „pojačivač” djelovanja.
English: How does Telzir work?
Croatian: Kako djeluje Telzir?
English: Although the Agency noted that the use of ritonavir-boosted Telzir had not been studied sufficiently in heavily pretreated patients and that studies carried out in children did not compare Telzir with a comparator medicine, it decided that Telzir's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Iako je Agencija napomenula da upotreba lijeka Telzir pojačanog ritonavirom nije dovoljno ispitana u bolesnika koji su prethodno primali snažno liječenje i da tijekom ispitivanja provedenih među djecom lijek Telzir nije uspoređen s drugim lijekom, odlučila je da koristi lijeka Telzir nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: The most common side effects in adults taking Telzir (seen in more than 1 patient in 10) are diarrhoea and increases in the levels of cholesterol (a type of fat) in the blood.
Croatian: Najčešće su nuspojave lijeka Telzir u odraslih osoba (zabilježene u više od 1 na 10 bolesnika) proljev i povišena razina kolesterola (vrste masti) u krvi.
English: Similar results were seen in the other study comparing ritonavir-boosted Telzir with ritonavir-boosted lopinavir, with around three-quarters of both groups of previously untreated patients having viral loads below 400 copies/ml.
Croatian: Slični su rezultati postignuti u drugom ispitivanju u kojemu je lijek Telzir pojačan ritonavirom uspoređen s lopinavirom pojačanim ritonavirom: otprilike tri četvrtine obiju skupina prethodno neliječenih bolesnika imale su virusno opterećenje ispod 400 kopija/ml.
English: Patients in these three adult studies also took two reverse-transcriptase inhibitors (another type of antiviral medicine) in addition to Telzir or the medicine Telzir was being compared with.
Croatian: Bolesnici su u ta tri ispitivanja na odraslim osobama primali i dva inhibitora reverzibilne transkriptaze (druga vrsta protuvirusnih lijekova) kao dodatak lijeku Telzir ili lijeku s kojim je Telzir uspoređivan.
English: Adults with liver problems should take a reduced dose of Telzir and be closely monitored for side effects and their response to treatment.
Croatian: Odrasle osobe koje imaju problema s jetrom trebaju uzimati smanjenu dozu lijeka Telzir i biti pod pomnim liječničkim nadzorom kako bi se pratile nuspojave i odgovor na liječenje.
English: Two of the studies in previously untreated patients showed that Telzir in combination with other antiviral medicines was as effective as comparator medicines.
Croatian: U dva od tri ispitivanja u bolesnika koji prethodno nisu bili liječeni pokazalo se da je lijek Telzir u kombinaciji s drugim protuvirusnim lijekovima jednako učinkovit kao i usporedni lijekovi.
English: What benefits of Telzir have been shown in studies?
Croatian: Koje su koristi od lijeka Telzir utvrđene u ispitivanjima?
English: blocks an enzyme that is involved in the reproduction of HIV.
Croatian: Amprenavir, koji je prethodno bio dostupan u EU-u, blokira enzim koji sudjeluje u razmnožavanju HIV-a.
English: For the full list of side effects of Telzir, see the package leaflet.
Croatian: Potpuni popis zabilježenih nuspojava povezanih s lijekom Telzir potražite u uputi o lijeku.
English: Target species
Croatian: Ciljne vrste
English: EU (MA) number Invented name
Croatian: EU (MA) broj
English: Packaging Content Package size
Croatian: Put primjene Pakiranje Sadržaj Veličina pakiranj a
English: EU/1/03/249/016 Vivanza 10 mg Orodispersible tablet blister (alu/alu) 4 x 1 tablets (unit dose)
Croatian: EU/1/03/249/016 Vivanza 10 mg Raspadljiva tableta za usta
English: Strength Pharmaceutical form Route of administration
Croatian: Doza Farmaceutski oblik
English: MA (EU) Number Invented name
Croatian: Broj (EU) odobrenja
English: (Invented) name Strength Pharmaceutical Form Route of Administration
Croatian: Farmaceutski oblik Put primjene Unutarnje pakovanje
English: Immediate Packaging Pack size
Croatian: Veličina pakovanja
English: Invented name Strength
Croatian: (Zaštićeno) ime
English: EU Number
Croatian: EMA broj postupka
English: Packaging
Croatian: Doza
English: Package size
Croatian: Unutarnje pakiranje
English: 30 May 2013 EMA/318380/2013
Croatian: 25. srpnja 2013. EMA/318380/2013
English: Healthcare professionals should follow these recommendations:
Croatian: Zdravstveni djelatnici moraju pratiti ove preporuke:
English: Further information on the PRAC recommendation and the background to this review can be found on Agency's website.
Croatian: Dodatne informacije o preporuci PRAC-a i pozadini ovog pregleda mogu se pronaći na mrežnoj stranici Agencije.
English: • You should not stop taking these medicines before speaking to your doctor.
Croatian: • Ne smijete prestati uzimati ove lijekove prije razgovora sa svojim liječnikom.
English: • If you have any questions you should speak to your doctor or pharmacist.
Croatian: • Ako imate bilo kakva pitanja, obratite se svom liječniku ili ljekarniku.
English: Information to patients
Croatian: Informacije za pacijentice
English: Diane 35 was first authorised in 1985.
Croatian: Lijek Diane 35 je prvi put odobren 1985.
English: A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Croatian: Pregled ovih podataka je prvo provelo Povjerenstvo za ocjenu rizika na području farmakovigilancije (PRAC).
English: Cyproterone also supresses ovulation and therefore has a contraceptive effect.
Croatian: Ciproteron također sprječava ovulaciju i zato ima kontracepcijski učinak.
English: • You should always read the package leaflet and be aware that there is a low risk of blood clots with these medicines.
Croatian: • Uvijek morate pročitati uputu o lijeku i biti svjesni da s navedenim lijekovima postoji nizak rizik od krvnih ugrušaka.
English: The review of Diane 35 and its generics was initiated in February 2013 at the request of France, under Article 107i of Directive 2001/83/EC, also known as the urgent Union procedure.
Croatian: Pregled lijeka Diane 35 i njegovih generika je započeo u veljači 2013. na zahtjev Francuske, pod Člankom 107i Direktive 2001/83/EZ, poznat i kao hitan postupak u Uniji.
English: Despite the PRAC recommendation ANSM proceeded with the suspension of the marketing authorisation of these medicines in France.
Croatian: Unatoč preporuci PRAC-a, ANSM je nastavio sa suspenzijom odobrenja za stavljanje u promet ovih lijekova u Francuskoj.
English: • Healthcare professionals will be sent a letter with further details.
Croatian: • Zdravstvenim djelatnicima je poslano pismo sa detaljima u nastavku:
English: Its main responsibility is to resolve disagreements between Member States involved in mutual recognition or decentralised procedures, to ensure that patients have the same level of protection, no matter where they are in the EU.
Croatian: Njegova glavna zadaća je razriješiti neslaganja između zemalja članica koja se odnose na međusobno priznavanje i dencentralizirane postupke, kako bi se osiguralo da bolesnici imaju istu razinu zaštite, neovisno o tome gdje se nalaze u EU.
English: These recommendations have been endorsed by the CMDh, a body representing EU Member States.
Croatian: Ove preporuke je odobrio CMDh, tijelo koje predstavlja zemlje članice EU.
English: The efficacy in moderate and severe acne with or without seborrhoea and /or hirsutism is demonstrated in more than 30 clinical trials.
Croatian: Učinkovitost kod umjerenih i teških oblika akni sa ili bez seboreje i/ili hirzutizma dokazana je u više od 30 kliničkih ispitivanja.
English: The CMDh is a medicines regulatory body representing the EU Member States.
Croatian: CMDh je zakonodavno tijelo za lijekove koje predstavlja zemlje članice EU.
English: These medicines work by blocking the effects of a class of hormones called androgens.
Croatian: Navedeni lijekovi djeluju blokirajući učinak razreda hormona koji se nazivaju androgeni.
English: You should immediately report any relevant symptoms to your doctor, such as pain and swelling in the legs, or breathlessness and a sharp pain in the chest.
Croatian: Morate odmah prijaviti sve važne simptome svom liječniku, kao što su bol i oteklina nogu, ostajanje bez daha i oštra bol u prsištu.
English: The risk of thromboembolism occurring with these medicines is low and well known.
Croatian: Rizik od tromboembolije uz primjenu navedenih lijekova je nizak i dobro poznat.
English: The PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Croatian: Preporuke PRAC-a su poslane Koordinacijskoj grupi za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh), koja je donijela konačno mišljenje.
English: The review of Diane 35 and its generics was triggered by the French medicines agency, the National Agency for the Safety of Medicine and Health Products (ANSM), following its decision to suspend Diane 35 and its generics in France within three months.
Croatian: Ponovnu kontrolu lijeka Diane 35 i njegovih generika potaknula je Francuska agencija za lijekove, Nacionalna agencija za sigurnost lijekova i medicinskih proizvoda (ANSM), nakon odluke da se lijek Diane 35 i njegovi generici u Francuskoj suspendiraju na 3 mjeseca.
English: Medicines containing cyproterone acetate 2 mg and ethinylestradiol 35 micrograms have been approved via national procedures and are available on prescription under various trade names in all EU Member States except Cyprus.
Croatian: Lijekovi koji sadrže 2 mg ciproteron acetata i 35 mikrograma etinilestradiola odobreni su putem nacionalnih postupaka i dostupni su na recept pod različitim zaštićenim nazivima u svim zemljama članicama EU, osim Cipra.
English: • In the treatment of alopecia androgenetica and acne without androgenic features, the data on efficacy is limited.
Croatian: • Za liječenje androgenetske alopecije i akni bez androgenih obilježja postoje ograničeni podaci o učinkovitosti.
English: • If you are using these medicines for other conditions you should make a non-urgent appointment with your doctor to review your treatment.
Croatian: • Ako koristite ove lijekove za druga stanja, naručite se za pregled kod svog liječnika kako biste razmotrili Vaše liječenje.
English: These include providing educational materials to prescribers and patients highlighting the risks of thromboembolism, for example a prescriber checklist to ensure that the risks, together with the signs and symptoms, are discussed with the patient.
Croatian: To uključuje uvođenje edukativnih materijala za liječnike koji propisuju lijek i pacijentice u kojima se ističu rizici od tromboembolije, na primjer popis za provjeru za propisivača kako bi se osiguralo da se s pacijenticama razgovara o rizicima, kao i o znakovima i simptomima.
English: As the CMDh position was adopted by majority vote and not by consensus, the CMDh position will now be sent to the European Commission, which will take a legally binding decision throughout the EU.
Croatian: Budući da je mišljenje CMDh-a prihvaćeno većinom glasova, a ne konsenzusom, mišljenje CMDh-a je poslano Europskoj komisiji koja je odobrila pravno obvezujuću odluku u EU 25. srpnja 2013.
English: These recommendations are based on a review of all available data on the risk of thromboembolism as well as the benefits of Diane 35 and its generics:
Croatian: Ove preporuke se temelje na pregledu svih dostupnih podataka o riziku od tromboembolije kao i o svim koristima lijeka Diane 35 i njegovih generika:
English: • The review also showed that the excess risk of VTE is highest during the first year of use of Diane 35 and its generics or when restarting or switching from an oral hormonal contraceptive to Diane 35 and its generics after a pill-free interval of at least one month.
Croatian: • Pregled je pokazao i da je povećani rizik od VTE-a najveći tijekom prve godine uporabe lijeka Diane 35 i njegovih generika ili kad se ponovno započinje uzimati ili prelazi s drugog hormonskog oralnog kontraceptiva na lijek Diane 25 i njegove generike nakon razdoblja bez tableta od najmanje mjesec dana.
English: • Doctors should review patients on Diane 35 and generics in line with these recommendations at their next scheduled appointment.
Croatian: • Liječnici moraju preispitati pacijentice koje koriste lijek Diane 35 i njegove generike u skladu s ovim preporukama pri njihovom sljedećem posjetu.