FrancophonIA/ELRC3.0 huggingface dataset:
English: Primary vaccination: 2 injections of one dose (2 ml) - From the age of 96 days, with an interval of 3 weeks between injections to achieve duration of immunity over 6 months.
Croatian: - Od 96 dana starosti, u razmaku od 3 tjedna između injekcija za postizanje imuniteta u trajanju dužem od 6 mjeseci.
English: Cardboard box with 1 PET vial of 10 doses (20 ml), 25 doses (50 ml) or 50 doses (100 ml) with a rubber stopper and flanged cap.
Croatian: Kartonska kutija s 1 PET bočicom od 10 doza (20 ml), 25 doza (50 ml) ili 50 doza (100 ml) s gumenim čepom i rubnim zatvaračem.
English: PET vials: 20 ml Polyethylene terephthalate (PET) vials, clear 50 ml PET vials, clear
Croatian: 20 ml polietilen tereftalat (PET) bočice, prozirne, 50 ml PET bočice, prozirne, 100 ml PET bočice, prozirne.
English: EU/2/09/102/003 EU/2/09/102/006
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/09/102/003
English: IM
Croatian: NUSPOJAVE
English: Intramuscular use.
Croatian: Zatvarač: rubni zatvarač.
English: 100 ml PET vials, clear
Croatian: 100 ml bočice, staklo tip II.
English: Further information on Truvada can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Dodatne informacije o lijeku Truvada nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This overview was last updated in 02-2018.
Croatian: Sažetak je posljednji put ažuriran u 02. 2018.
English: What is Truvada and what is it used for?
Croatian: Što je Truvada i za što se koristi?
English: Truvada is available as tablets.
Croatian: Lijek Truvada dostupan je kao tablete.
English: This means that it is converted into tenofovir in the body.
Croatian: To znači da se u tijelu pretvara u tenofovir.
English: Other information about Truvada
Croatian: Ostale informacije o lijeku Truvada
English: What measures are being taken to ensure the safe and effective use of Truvada?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Truvada?
English: The level of protection depended on how well individuals stuck to taking their medicine.
Croatian: Razina zaštite ovisila je o tome koliko su se pojedinci pridržavali uzimanja lijeka.
English: There is a risk that pre-exposure prophylaxis may encourage risky behaviour but one of the main studies found that participation in the study reduced risky behaviour.
Croatian: Postoji rizik da predekspozicijska profilaksa može potaknuti rizično ponašanje, no u jednom od glavnih ispitivanja pokazalo se da je sudjelovanje u ispitivanju smanjilo rizično ponašanje.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Truvada on 21 February 2005.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Truvada u promet koje vrijedi na prostoru Europske unije od 21. veljače 2005.
English: What are the risks associated with Truvada?
Croatian: Koji su rizici povezani s lijekom Truvada?
English: Why is Truvada authorised in the EU?
Croatian: Zašto je lijek Truvada odobren u EU-u?
English: It should be used in combination with safer sex practices, such as use of condoms.
Croatian: Treba se primjenjivati u kombinaciji sa zaštićenim spolnim odnosom, kao što je upotreba prezervativa.
English: An overview of Truvada and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Truvada i zašto je odobren u EU-u
English: Truvada does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Truvada ne liječi infekciju HIV-om ili AIDS, ali može odgoditi oštećenje imunosnog sustava i razvoj infekcija i bolesti povezanih sa AIDS-om.
English: Truvada (emtricitabine / tenofovir disoproxil)
Croatian: Truvada (emtricitabin/tenofovirdizoproksil )
English: Around two-thirds of the patients achieved and maintained viral load below 50 copies/ml after 48 weeks.
Croatian: Kod otprilike dvije trećine bolesnika postignuto je i održano virusno opterećenje ispod 50 kopija/ml nakon 48 tjedana.
English: Both active substances have been authorised in the European Union (EU) since the early 2000s: emtricitabine was authorised as Emtriva in 2003, and tenofovir disoproxil was authorised as Viread in
Croatian: Obje djelatne tvari odobrene su u Europskoj uniji (EU) još od ranih 2000-ih: emtricitabin je odobren kao Emriva od 2003. dok je tenofovirdizoproksil odobren kao Viread od 2002.
English: Side effects reported with Truvada are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Truvada pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: If patients with HIV-1 infection need to stop taking emtricitabine or tenofovir, or need to take different doses, they will need to take medicines containing emtricitabine or tenofovir disoproxil separately.
Croatian: Ako bolesnici s infekcijom virusom HIV-1 moraju prekinuti liječenje emtricitabinom ili tenofovirom ili moraju uzimati drugačije doze, moraju odvojeno uzimati lijekove koji sadrže emtricitabin ili tenofovirdizoproksil.
English: The Agency also considered that the benefit of Truvada has been shown for pre-exposure prophylaxis but the level of protection depends on how well individuals stick to the recommended dose schedule.
Croatian: Odbor je također uzeo u obzir da se lijek Truvada pokazao korisnim za predekspozicijsku profilaksu, ali razina zaštite ovisi o tome koliko se pojedinci pridržavaju preporučenog rasporeda doziranja.
English: The second study involved over 4,700 heterosexual couples, each with one partner who did not have HIV-1 infection and the other who had the infection.
Croatian: Drugo je ispitivanje uključivalo više od 4 700 heteroseksualnih parova kod kojih jedan partner nije imao infekciju virusom HIV-1, dok je drugi bio zaražen.
English: As for all medicines, data on the use of Truvada is continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Truvada kontinuirano se prate.
English: Truvada was more effective than placebo for preventing HIV-1 infection.
Croatian: Lijek Truvada bio je djelotvorniji od placeba u sprečavanju infekcije virusom HIV-1.
English: When the active substances emtricitabine or tenofovir are given separately, the most common side effects (seen in more than 1 patient in 10) also include hypophosphataemia (low levels of phosphates in the blood), headache, dizziness, vomiting, rash, weakness and raised blood levels of creatine kinase (an enzyme found in muscles).
Croatian: Kad su djelatne tvari emtricitabin ili tenofovir primijenjene zasebno, najčešće nuspojave (koje su se javile u više od jednog od 10 bolesnika) uključivale su još hipofosfatanemiju (niska razina fosfata u krvi), glavobolju, vrtoglavicu, povraćanje, osip, slabost i povišene razine kreatin kinaze u krvi (enzim koji se nalazi u mišićima).
English: The European Medicines Agency noted that the benefit of Truvada for treating HIV-1 infection has only been shown in patients who have not taken HIV treatment before, but that the simplified dosing regimen offered by the combination tablet taken once a day may help patients to stick to their treatment.
Croatian: Europska agencija za lijekove zaključila je da su koristi lijeka Truvada za liječenje infekcija virusom HIV-1 dokazane samo u bolesnika koji prije toga nisu bili liječeni, ali da pojednostavljeni dozni režim koji se sastoji od kombinacijske terapije u kojoj se jedna tableta uzima jedanput dnevno može pomoći bolesnicima da se pridržavaju svog liječenja.
English: Truvada contains two active substances, emtricitabine (200 mg) and tenofovir disoproxil (245 mg).
Croatian: Truvada sadrži dvije djelatne tvari, emtricitabin (200 mg) i tenofovirdizoproksil (245 mg).
English: The Agency concluded that Truvada's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Agencija je zaključila da koristi od lijeka Truvada nadmašuju s njim povezane rizike te je preporučila izdavanje odobrenja za stavljanje lijeka u promet.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Truvada have also 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 Truvada također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: Individuals taking Truvada to prevent HIV-1 infection should be tested at least every 3 months to make sure that they are free of HIV-1.
Croatian: Pojedinci koji uzimaju lijek Truvada kako bi spriječili infekciju virusom HIV-1 trebaju se testirati najmanje svaka tri mjeseca kako bi bili sigurni da nisu zaraženi virusom HIV-1.
English: The main measure of effectiveness was the number of adults who tested positive for HIV-1 infection.
Croatian: Glavna mjera djelotvornosti bio je broj odraslih osoba koje su bile pozitivne na infekciju virusom HIV-1.
English: The recommended dose for treating or preventing HIV-1 infection is one tablet once a day, preferably taken with food.
Croatian: Preporučena doza za liječenje ili sprečavanje infekcije virusom HIV-1 je jedna tableta jedanput dnevno te je poželjno da se uzima s hranom.
English: How does Truvada work?
Croatian: Kako djeluje Truvada?
English: The main measure of effectiveness was the proportion of patients whose HIV-1 level in the blood (viral load) had fallen below a defined level.
Croatian: Glavna mjera djelotvornosti bio je udio bolesnika u kojih se razina HIV-1 u krvi (virusnog opterećenja) spustila ispod definirane razine.
English: The effectiveness of Truvada in adolescents was supported by studies showing that emtricitabine or tenofovir disoproxil reduced viral load when given with other antivirals to HIV-infected patients aged from 12 to 18 years, as well as evidence that the active ingredients are distributed similarly in the bodies of adolescents to those of adults and so would be expected to act in the same way.
Croatian: Djelotvornost lijeka Truvada u adolescenata dokazana je u ispitivanjima koja su pokazala da emtricitabin ili tenofovirdizoproksil smanjuje virusno opterećenje kad se primjenjuje s drugim protuvirusnim lijekovima u bolesnika zaraženih HIV-om u dobi od 12 do 18 godina, kao i dokazom da se djelatne tvari slično distribuiraju u organizmima adolescenata i odraslih te se očekuje i slično djelovanje.
English: For pre-exposure prophylaxis of HIV-1 infection, it is expected that Truvada in the blood will stop the virus from multiplying and spreading from the site of infection in case the individual is exposed to the virus.
Croatian: Kada je riječ o predekspozicijskoj profilaksi infekcije virusom HIV-1, očekuje se da će Truvada u krvi zaustaviti razmnožavanje virusa i širenje s mjesta infekcije ako je osoba izložena virusu.
English: What benefits of Truvada have been shown in studies?
Croatian: Koje su koristi lijeka Truvada dokazane u ispitivanjima?
English: Both emtricitabine and tenofovir work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Croatian: Emtricitabin i tenofovir djeluju na sličan način onemogućujući djelovanje reverzne transkriptaze, enzima što ga proizvodi HIV, a koji omogućuje zarazu stanica i stvaranje još virusa.
English: Truvada's active substances, taken in combination with other antiviral medicines, reduced viral load in the majority of patients and were more effective than the comparator medicines.
Croatian: Djelatne tvari lijeka Truvada, u kombinaciji s drugim protuvirusnim lijekovima, smanjile su virusno opterećenje u većine bolesnika te su bile djelotvornije od komparatora.
English: Two main studies have evaluated the addition of Truvada to standard preventative measures for preexposure prophylaxis.
Croatian: U dvama glavnim ispitivanjima ispitan je lijek Truvada kao dodatak standardnim preventivnim mjerama za predekspozicijsku profilaksu.
English: In addition it may be used from the age of 12 in adolescents with HIV who are resistant to first-line treatments or who cannot take them because of side effects.
Croatian: Nadalje, može se primjenjivati u adolescenata u dobi od 12 godina i starijih koji su zaraženi HIV-om, a otporni su na lijekove prve linije ili ih ne mogu primati zbog nuspojava.
English: In the first study involving over 2,400 men who have sex with men, 3.9% (48 out of 1,224) individuals taking Truvada tested positive for HIV-1 infection compared with 6.8% (83 out of 1,217) individuals taking placebo.
Croatian: U prvom ispitivanju, u kojem je sudjelovalo više od 2 400 muškaraca koji su imali spolne odnose s muškarcima, 3,9 % (48 od 1 224) pojedinaca koji su uzimali lijek Truvada imali su pozitivan test na infekciju virusom HIV-1 u usporedbi sa 6,8 % (83 od 1 217) pojedinaca koji su uzimali placebo.
English: The first study compared the combination of emtricitabine and tenofovir disoproxil with the combination of lamivudine and zidovudine (other antiviral medicines).
Croatian: U prvom je ispitivanju uspoređena kombinacija emtricitabina i tenofovirdizoproksila s kombinacijom lamivudina i zidovudina (drugi protuvirusni lijekovi).
English: Healthcare professionals will also receive a brochure and reminder card to hand out to individuals receiving Truvada for pre-exposure prophylaxis.
Croatian: Zdravstveni radnici dobit će i brošuru te karticu s podsjetnikom namijenjenu osobama koje primaju lijek Truvada za predekspozicijsku profilaksu.
English: Of the individuals taking Truvada, 0.8% (13 out of 1,576) tested positive for HIV-1 infection over 1 year compared with 3.3% (52 out of 1,578) of those taking placebo.
Croatian: Od pojedinaca koji su uzimali lijek Truvada 0,8 % (13 od 1 576) imali su pozitivan test na infekciju virusom HIV-1 nakon godinu dana u usporedbi s 3,3 % (52 od 1 578) onih koji su uzimali placebo.
English: Of the patients taking the active substances of Truvada, 80% (194 out of 244) achieved and maintained viral load below 50 HIV1 copies/ml by 48 weeks, compared with 70% of the patients taking the comparator medicines (171 out of 243).
Croatian: Od bolesnika koji su uzimali djelatne tvari lijeka Truvada, 80 % (194 od 244) postiglo je i održalo virusno opterećenje ispod 50 HIV-1 kopija/ml tijekom 48 tjedana u usporedbi sa 70 % bolesnika koji su uzimali lijekove komparatore (171 d 243).
English: Truvada can only be obtained with a prescription, and treatment should be started by a doctor who has experience in the management of HIV infection.
Croatian: Truvada se izdaje samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u liječenju infekcije HIV-om.
English: In children, skin discoloration and anaemia (low red blood cell counts) are also common side effects.
Croatian: U djece su česte nuspojave bile i diskoloracija kože i anemija (smanjen broj crvenih krvnih zrnaca).
English: The company that markets Truvada will provide an information pack to doctors which covers the risk of reduced kidney function with Truvada in adults and children, and information about use in adults for pre-exposure prophylaxis.
Croatian: Tvrtka koja stavlja lijek Truvada u promet liječnicima će dostaviti informacije koje će obuhvatiti rizike od smanjene funkcije bubrega prilikom primjene lijeka Truvada u odraslih i djece te informacije o primjeni u odraslih osoba za predekspozicijsku profilaksu.
English: The second study examined the effects of emtricitabine and tenofovir disoproxil, taken with lopinavir and ritonavir (other antiviral medicines) in 196 patients with HIV-1 infection.
Croatian: U drugom su ispitivanju ispitani učinci emtricitabina i tenofovirdizoproksila koji su primijenjeni s lopinavirom i ritonavirom (drugim protuvirusnim lijekovima) u 196 bolesnika zaraženih virusom HIV-1.
English: The most common side effects in adults treated with Truvada are diarrhoea and nausea (feeling sick).
Croatian: Najčešće nuspojave u odraslih osoba liječenih lijekom Truvada su proljev i mučnina.
English: In both studies Truvada was compared with placebo (a dummy treatment) in adults at high risk of sexually transmitted HIV-1 infection.
Croatian: U obama ispitivanjima lijek Truvada uspoređen je s placebom (prividno liječenje) u odraslih s visokim rizikom od spolno prenosive infekcije virusom HIV-1.
English: Truvada is used in combination with at least one other HIV medicine to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Lijek Truvada je protuvirusni je lijek koji se primjenjuje u kombinaciji s najmanje još jednim protuvirusnim lijekom za liječenje odraslih osoba zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: Truvada is also used to help prevent sexually transmitted HIV-1 infection in adults and adolescents who are at high risk of being infected (pre-exposure prophylaxis or PrEP).
Croatian: Truvada se koristi i za sprečavanje spolno prenosive infekcije virusom HIV-1 u odraslih osoba kod kojih postoji velik rizik od infekcije („predekspozicijska profilaksa”).
English: Truvada can be used for pre-exposure prophylaxis only in individuals who have been tested to be free of HIV infection.
Croatian: Truvada se može upotrebljavati za predekspozicijsku profilaksu samo u osoba u kojih je testiranjem dokazano da nemaju infekciju virusom HIV-a.
English: How is Truvada used?
Croatian: Kako se Truvada koristi?
English: Truvada contains two active substances: emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir.
Croatian: Truvada sadržava dvije djelatne tvari: emtricitabin, nukleozidni inhibitor reverzne transkriptaze, i tenofovirdizoproksil, „prolijek” tenofovira.
English: For the full list of all side effects reported with Truvada, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Truvada potražite u uputi o lijeku.
English: Two main studies have examined the effects of Truvada's active substances, emtricitabine and tenofovir disoproxil, in adults infected with HIV-1 who had not been treated before.
Croatian: Učinci djelatnih tvari lijeka Truvada, emtricitabina i tenofovirdizoproksila, ispitani su u dvama ispitivanjima u odraslih osoba zaraženih virusom HIV-1 koji prije nisu bili liječeni.
English: For the treatment of HIV-1 infection, Truvada, taken in combination with at least one other HIV medicine, reduces the amount of HIV in the blood and keeps it at a low level.
Croatian: Kad se uzima u kombinaciji s najmanje još jednim protuvirusnim lijekom za liječenje infekcije virusom HIV-1, Truvada smanjuje koncentraciju HIV-a u krvi i održava je na niskoj razini.
English: Both combinations were taken with efavirenz (another antiviral medicine) by patients with HIV-1 infection.
Croatian: Bolesnici s infekcijom virusom HIV-1 obje su kombinacije uzimali zajedno s efavirenzom (drugim protuvirusnim lijekom).
English: You may notice this as dizziness when standing up.
Croatian: Možda ćete to primijetiti kao omaglicu prilikom ustajanja.
English: However, it is not known whether telmisartan was the cause.
Croatian: Međutim, nije poznato je li telmisartan bio uzrok.
English: You can take Tolura with or without food.
Croatian: Možete uzimati Toluru sa ili bez hrane.
English: If you take more Tolura than you should
Croatian: Ako uzmete više Tolure nego što ste trebali
English: Always take Tolura exactly as your doctor has told you.
Croatian: Uvijek uzimajte Toluru točno onako kako Vam je rekao Vaš liječnik.
English: See also information under the heading “Do not take Tolura”.
Croatian: Vidjeti također informacije pod naslovom “Nemojte uzimati Toluru“.
English: It is important that you take Tolura every day until your doctor tells you otherwise.
Croatian: Važno je uzimati Toluru svaki dan, dok Vam liječnik ne kaže drugačije.
English: What Tolura is and what it is used for
Croatian: Što je Tolura i za što se koristi
English: Each blister contains 7 or 10 tablets.
Croatian: Svaki blister sadrži 7 ili 10 tableta.
English: Other medicines and Tolura
Croatian: Drugi lijekovi i Tolura
English: Currently available data are described in section 5.1 and 5.2 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 5.1 i 5.2, međutim, nije moguće dati preporuku o doziranju.
English: The event may be a chance finding or related to a mechanism currently not known (see also section 5.1).
Croatian: Taj događaj može biti slučajan ili povezan s trenutno nepoznatim mehanizmom (također vidjeti dio 5.1).
English: The safety data from this study in patients aged 6 to < 18 years appeared generally similar to that observed in adults.
Croatian: Podaci o sigurnosti iz ovog ispitivanja u bolesnika u dobi od 6 do < 18 godina općenito su bili slični onima uočenim u odraslih.
English: - Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals).
Croatian: - Povišene razine aldosterona (zadržavanje vode i soli u tijelu zajedno s neravnotežom različitih minerala u krvi).
English: Your doctor can tell you if you are at high risk for such events.
Croatian: Vaš liječnik će Vam reći da li spadate u rizičnu skupinu za takve događaje.
English: - Lithium containing medicines to treat some types of depression.
Croatian: - Lijekovi koji sadrže litij za liječenje nekih vrsta depresije.
English: 02-235 Warszawa Poland
Croatian: 02-235 Warszawa Poljska
English: Talk to your doctor before taking Tolura: - if you are taking digoxin.
Croatian: Razgovarajte sa svojim liječnikom prije uzimanja Tolure: - ako uzimate digoksin.
English: <2D barcode carrying the unique identifier included.>
Croatian: <Sadrži 2D barkod s jedinstvenim identifikatorom.>
English: Its clinical significance and relevance is unknown.
Croatian: Nije poznat njegov klinički značaj i relevantnost.
English: Some side effects can be serious and need immediate medical attention:
Croatian: Neke nuspojave mogu biti teške i zahtjevaju hitnu liječničku skrb:
English: Równoległa 5, 02-235 Warszawa, Poland
Croatian: Równolegla 5, 02-235 Warszawa, Poljska
English: Date of first authorisation: 4 June 2010 Date of latest renewal: 19 March 2015
Croatian: Datum posljednje obnove: 19 ožujka 2015
English: An increase in eosinophils reported in this patient population has not been recorded in adults.
Croatian: Porast eozinofila zabilježen u ovoj populaciji bolesnika nije zabilježen u odraslih.
English: Your doctor will normally advise you to stop taking Tolura before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Tolura.
Croatian: Liječnik će Vam obično savjetovati da prestanete uzimati Toluru prije nego ostanete trudni ili čim saznate da ste trudni te će Vam savjetovati uzimanje drugog lijeka umjesto Tolure.
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Croatian: Epidemiološki podaci vezani uz teratogeni rizik nakon izloženosti ACE inhibitorima tijekom prvog tromjesečja trudnoće ne omogućuju konačan zaključak; međutim, ne može se isključiti malen porast rizika.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list)) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.