FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that Effentora could not have been approved for the treatment of breakthrough pain in adults with long-term pain other than cancer pain.
Croatian: Na temelju pregleda podataka te odgovora tvrtke na popis pitanja CHMP-a, u trenutku povlačenja, CHMP je izrazio svoju zabrinutost oko određenih pitanja te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za Effentora za liječenje prodorne boli u odraslih osoba s dugoročnom boli, izuzev za bol uzrokovanom rakom.
English: The Committee noted that several cases of misuse or abuse of the medicine had been reported in the studies, and was concerned about the risk of addiction in non-cancer patients when using Effentora in the long term.
Croatian: Povjerenstvo je uočilo da je u ispitivanjima prijavljeno nekoliko slučaja zlouporabe ili prekomjerne uporabe lijeka te je bilo zabrinuto zbog rizika od ovisnosti u bolesnika koji nisu oboljeli od raka prilikom dugotrajne uporabe lijeka Effentora.
English: In Effentora, it is given as a buccal tablet, so that fentanyl is absorbed through the lining of the mouth.
Croatian: Fentanil je u lijeku Effentora dostupan u obliku bukalnih tableta, tako da se apsorbira kroz sluznicu usta.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Effentora in patients with non-cancer-related long-term pain did not outweigh its risks.
Croatian: Sukladno navedenome, u vrijeme povlačenja, CHMP je smatrao kako koristi lijeka Effentora ne nadmašuju s njim povezane rizike u bolesnika s dugoročnom boli koja nije povezana s rakom.
English: Package Leaflet:
Croatian: Nuspojave:
English: Anakinra - Thrombocytopenia (EPITT no 18337)
Croatian: Anakinra - trombocitopenija (EPITT br. 18337)
English: In clinical studies in RA and CAPS patients, thrombocytopenia has been reported in 1.9% of treated patients compared to 0.3% in the placebo group.
Croatian: U kliničkim ispitivanjima provedenim u bolesnika s RA-om i CAPS-om, trombocitopenija je prijavljena u 1,9°% liječenih bolesnika, u usporedbi s 0,3°% bolesnika u skupini koja je primala placebo.
English: Adopted at the 5-8 October 2015 PRAC
Croatian: Usvojeno na sjednici PRAC-a 5. - 8. listopada 2015.
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/661880/2015
Croatian: Novi tekst informacija o lijeku - izvadak iz preporuka PRAC-a vezanih uz signale EMA/PRAC/680915/2015
English: Thrombocytopenia
Croatian: Trombocitopenija
English: Blood and lymphatic system disorders Frequency ‘common': thrombocytopenia
Croatian: Poremećaji krvnog i limfnog sustava Učestalost "često": trombocitopenija
English: The thrombocytopenias have been mild, i.e. platelet counts have been >75 x109/l.
Croatian: Trombocitopenija je bila blažeg oblika, tj. broj trombocita je bio >75 x109/l.
English: New product information wording - Extracts from PRAC recommendations on signals
Croatian: Novi tekst informacija o lijeku - izvadak iz preporuka PRAC-a vezanih uz signale
English: During post-marketing use of Kineret, thrombocytopenia has been reported, including occasional case reports indicating severe thrombocytopenia (i.e. platelet counts <10 x109/l).
Croatian: Tijekom primjene lijeka Kineret nakon stavljanja u promet prijavljena je trombocitopenija, uključujući i povremene prijave slučajeva koji ukazuju na tešku trombocitopeniju (tj. broj trombocita <10 x109/l).
English: Common side effects (may affect up to 1 in 10 people): - Thrombocytopenia (low level of blood platelets).
Croatian: Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba): - Trombocitopenija (smanjen broj trombocita u krvi).
English: Summary of Product Characteristics: Section 4.8 - Undesirable effects:
Croatian: Sažetak opisa svojstava lijeka: Dio 4.8.
English: Possible side effects
Croatian: Uputa o lijeku: 4. Moguće nuspojave
English: 1 bag
Croatian: 1 vrećica
English: EU/1/16/1121/001 Zalmoxis
Croatian: EU/1/16/1121/001 Zalmoxis 5-20 x 106 stanica/ml
English: Intravenous use Ethylen-vinyl-acetate cryo bag (EVA)
Croatian: Krio vrećica od etilen vinil acetat (EVA)
English: Dispersion for infusion
Croatian: Disperzija za infuziju
English: ml
Croatian: Doza
English: Immediate Packaging Content Pack size
Croatian: Sastav Veličina pakovanja
English: 5-20 x 106 cells/mL
Croatian: 10-100 ml
English: Luxembourg NV AstraZeneca SA Egide Van Ophemstraat 110
Croatian: Luksemburg NV AstraZeneca SA Egide Van Ophemstraat
English: Czech Republic AstraZeneca UK Limited 2 Kingdom Street
Croatian: Češka Republika AstraZeneca UK Limited 2 Kingdom Street
English: United Kingdom AstraZeneca UK Limited 600 Capability Green
Croatian: Velika Britanija AstraZeneca UK Limited 600 Capability Green
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat 110
Croatian: NV AstraZeneca SA Egide Van Ophemstraat
English: AstraZeneca S.p.A. Palazzo Volta Via F. Sforza 20080 - Basiglio (Milano) Italy
Croatian: Sforza 20080 - Basiglio (Milano) Italy
English: Intravenous use vial (glass)
Croatian: 10 mg/ml otopina za infuziju intravenski bočica (staklo)
English: (Invented) name
Croatian: Broj EU odobrenja (Zaštićeno) ime
English: The recommended dose is one capsule once a day at the same time each day.
Croatian: Preporučena doza je jedna kapsula jednom dnevno u isto vrijeme svakog dana.
English: Patients should not use more than one capsule in a day.
Croatian: Bolesnici ne smiju uzeti više od jedne kapsule dnevno.
English: The Agency also noted that the fact that the medicine is used once a day may help patients to adhere to their treatment.
Croatian: Agencija je također smatrala kako će činjenica da se lijek primjenjuje jednom dnevno možda doprinijeti tomu da se bolesnici pridržavaju terapije.
English: Further information on Seebri Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Seebri Breezhaler nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: the main measure of effectiveness was improvement in patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Croatian: Glavno mjerilo učinkovitosti u oba ispitivanja bilo je poboljšanje forsiranog izdisajnog volumena bolesnika (FEV1, maksimalni volumen zraka koji osoba može izdahnuti u sekundi).
English: This helps to keep the airways open and allows the patient to breathe more easily.
Croatian: To pomaže pri održavanju dišnih putova otvorenima i omogućuje bolesnicima olakšano disanje.
English: COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing.
Croatian: KOPB je dugotrajna bolest kod koje su dišni putovi i zračne vrećice u plućima oštećeni ili začepljeni, što dovodi do poteškoća pri disanju.
English: Seebri Breezhaler (glycopyrronium bromide) EMA/326863/2018
Croatian: Seebri Breezhaler (glikopironijev bromid) EMA/326863/2018
English: After 12 weeks of treatment, Seebri Breezhaler increased FEV1 by 97 ml more than with placebo in the first study, and by 108 ml more in the second study.
Croatian: U prvom ispitivanju, nakon 12 tjedana terapije lijekom Seebri Breezhaler FEV1 se povećao za 97 ml više nego uz primjenu placeba, a u drugom ispitivanju za 108 ml više.
English: The most common side effects with Seebri Breezhaler (seen in more than 1 patient in 100) are dry mouth, nasopharyngitis (inflammation of the nose and throat), insomnia (difficulty sleeping), muscle and bone pain and gastroenteritis (diarrhoea and vomiting).
Croatian: Najčešće nuspojave lijeka Seebri Breezhaler (zabilježene u više od 1 na 100 bolesnika) su suhoća usta, nazofaringitis (upala nosa i grla), insomnija (nesanica), bolovi u mišićima i kostima te gastroenteritis (proljev i povraćanje).
English: To take a dose, the patient places a capsule into the inhaler and breathes in through the mouth the powder from the capsule.
Croatian: Kako bi uzeli potrebnu dozu, bolesnici trebaju staviti kapsulu u inhalator i kroz usta udahnuti prašak iz kapsule.
English: Side effects reported with Seebri Breezhaler are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Seebri Breezhaler pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Seebri Breezhaler capsules, which contain a powder for inhalation, are only used with the Seebri Breezhaler inhaler and must not be swallowed.
Croatian: Kapsule lijeka Seebri Breezhaler, koje sadrže prašak za inhaliranje, primjenjuju se samo s inhalatorom za Seebri Breezhaler i ne smiju se progutati.
English: The European Medicines Agency noted that Seebri Breezhaler had a modest but relevant benefit for patients in terms of improving lung function, and also improved the symptoms of COPD.
Croatian: Europska agencija za lijekove smatrala je da Seebri Breezhaler ima skromnu, ali važnu korist za bolesnike jer poboljšava plućnu funkciju te ublažava simptome KOPB-a.
English: Seebri Breezhaler is a medicine that is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Croatian: Seebri Breezhaler je lijek koji se primjenjuje za ublažavanje simptoma kronične opstruktivne plućne bolesti (KOPB) u odraslih osoba.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Seebri Breezhaler 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 Seebri Breezhaler nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: In addition, there were no major safety concerns with Seebri Breezhaler, with side effects similar to other muscarinic receptor antagonist medicines.
Croatian: Osim toga, nisu postojali ozbiljni razlozi za zabrinutost pri primjeni lijeka Seebri Breezhaler, a nuspojave su bile slične onima za druge antagoniste muskarinskih receptora.
English: Seebri Breezhaler received a marketing authorisation valid throughout the EU for Seebri Breezhaler on 28 September 2012.
Croatian: Lijek Seebri Breezhaler dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 28. rujna 2012.
English: Seebri Breezhaler (glycopyrronium bromide)
Croatian: Seebri Breezhaler (glikopironijev bromid)
English: This means that it widens the airways by blocking muscarinic receptors (targets) in muscle cells in the lungs.
Croatian: To znači da proširuje dišne putove blokirajući muskarinske receptore u mišićnim stanicama u plućima.
English: Muscarinic receptors control the contraction of muscles and when glycopyrronium bromide is inhaled, it relaxes the muscles of the airways.
Croatian: Muskarinski receptori kontroliraju kontrakciju mišića, a udisanjem glikopironijeva bromida dolazi do opuštanja mišića u dišnim putovima.
English: What is Seebri Breezhaler and what is it used for?
Croatian: Što je Seebri Breezhaler i za što se koristi?
English: Therefore, the Agency decided that Seebri Breezhaler's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Agencija je stoga zaključila da koristi od lijeka Seebri Breezhaler nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: An overview of Seebri Breezhaler and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Seebri Breezhaler i zašto je odobren u EU-u
English: As for all medicines, data on the use of Seebri Breezhaler are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Seebri Breezhaler kontinuirano se prate.
English: For more information about treatment with Seebri Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Seebri Breezhaler pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se liječniku ili ljekarniku.
English: The active substance in Seebri Breezhaler, glycopyrronium bromide, is a muscarinic receptor antagonist.
Croatian: Djelatna tvar lijeka Seebri Breezhaler, glikopironijev bromid, antagonist je muskarinskih receptora.
English: Why is Seebri Breezhaler authorised in the EU?
Croatian: Zašto je lijek Seebri Breezhaler odobren u EU-u?
English: Other information about Seebri Breezhaler
Croatian: Ostale informacije o lijeku Seebri Breezhaler
English: Seebri Breezhaler is used for maintenance (regular) treatment.
Croatian: Lijek Seebri Breezhaler primjenjuje se kao (redovita) terapija održavanja.
English: What are the risks associated with Seebri Breezhaler?
Croatian: Koji su rizici povezani s lijekom Seebri Breezhaler?
English: For the full list of all side effects and restrictions with Seebri Breezhaler, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja zabilježenih pri primjeni lijeka Seebri Breezhaler potražite u uputi o lijeku.
English: What measures are being taken to ensure the safe use of Seebri Breezhaler?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Seebri Breezhaler?
English: For more information about using Seebri Breezhaler, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Seebri Breezhaler pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Seebri Breezhaler can only be obtained with a prescription.
Croatian: Lijek Seebri Breezhaler izdaje se samo na liječnički recept.
English: How is Seebri Breezhaler used?
Croatian: Kako se Seebri Breezhaler koristi?
English: What benefits of Seebri Breezhaler have been shown in studies?
Croatian: Koje su koristi od lijeka Seebri Breezhaler utvrđene u ispitivanjima?
English: How does Seebri Breezhaler work?
Croatian: Kako djeluje Seebri Breezhaler?
English: Seebri Breezhaler was found to be more effective than placebo (a dummy treatment) at relieving symptoms of COPD in two main studies involving a total of 1,888 patients with COPD.
Croatian: U dvama glavnim ispitivanjima kojima je bilo obuhvaćeno ukupno 1 888 osoba oboljelih od KOPB-a utvrđeno je da je lijek Seebri Breezhaler učinkovitiji od placeba (prividnog liječenja) pri ublažavanju
English: Seebri Breezhaler contains the active substance glycopyrronium bromide.
Croatian: Sadrži djelatnu tvar glikopironijev bromid.
English: 20 mg/ml
Croatian: 25 mg 75 mg 20 mg/ml
English: Content (concentration) Package size
Croatian: Sastav (koncentracija)
English: Oral solution bottle (HDPE) 230 ml
Croatian: Kroz usta boca (HDPE/alu) boca (HDPE/alu) boca (HDPE)
English: 1 bottle + 1 adapter + 1 oral applicator
Croatian: 180 (2 x 90) tableta (višestruko pakiranje) 120 tableta 120 tableta 1 boca + 1 nastavak + 1 oralni aplikator
English: (Invented) name Strength Pharmaceutical Form
Croatian: Farmaceutski oblik Put primjene Unutarnje pakiranje
English: Route of administration
Croatian: Kroz usta
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for direct-acting antiviral agents (DAAs) indicated in the
Croatian: • PRAC je razmatrao postupak u skladu s člankom 20. Uredbe (EZ) br. 726/2004 iz podataka o farmakovigilanciji za lijekove koji sadrže antivirusne lijekove (DAA) indicirane za liječenje
English: As both requests for the triggered procedure result from the evaluation of data resulting from pharmacovigilance activities, the EC requested the opinion to be adopted by the Committee for Medicinal Products for Human Use (CHMP) on the basis of a recommendation of the Pharmacovigilance
Croatian: Budući da oba zahtjeva za pokrenuti postupak proizlaze iz ocjenjivanja podataka na temelju aktivnosti farmakovigilancije, Europska komisija zatražila je od Odbora za lijekove za humanu uporabu (CHMP) da donese mišljenje na temelju preporuke Odbora za procjenu rizika u području farmakovigilancije (PRAC).
English: CHMP opinion and detailed explanation of the scientific grounds for the differences from the
Croatian: Mišljenje CHMP-a i detaljno objašnjenje znanstvene osnove za odstupanja od preporuke PRAC-a
English: Having reviewed the PRAC recommendation, the CHMP agreed with the overall scientific conclusions
Croatian: Nakon što je pregledao preporuku PRAC-a, CHMP se složio s općim znanstvenim zaključcima i razlozima za preporuku.
English: Some of the cases identified with DAAs had serious outcomes, with worsening of hepatic status and at least one case where the patient
Croatian: Neki od slučajeva s direktno djelujućim antivirusnim lijekovima imali su ozbiljne ishode, odnosno pogoršanje stanja jetre, a u barem jednom slučaju bolesnik je trebao transplantaciju jetre.
English: The current referral procedure was triggered by the European Commission (EC) to allow further investigation of the risk of hepatitis B virus replication after starting treatment with DAAs and recommend any appropriate measure to
Croatian: Europska komisija (EC) pokrenula je trenutačni postupak upućivanja radi dodatnog istraživanja rizika od replikacije virusa hepatitisa B nakon početka liječenja direktno djelujućim antivirusnim lijekovima i preporučivanja odgovarajućih mjera za smanjenje rizika.
English: Following the initiation of this review, results from a study (Reig et al. 2016) performed between October 2014 and December 2015 in Hepatology Units of four University Spanish hospitals in patients with chronic hepatitis C and a history of hepatocellular carcinoma (HCC) treated with DAAs suggested
Croatian: Nakon pokretanja ove procjene, rezultati istraživanja (Reig i drugi, 2016.) provedenog između listopada 2014. i prosinca 2015. na hepatološkim odjelima četiriju španjolskih bolnica na bolesnicima koji imaju kronični hepatitis C i anamnezu hepatocelularnog karcinoma (HCC) te su liječeni direktno djelujućim antivirusnim lijekovima, pokazuju neočekivano rano vraćanje HCC-a.
English: The product information will include a warning to inform about the risk of hepatitis B reactivation and
Croatian: Informacije o lijeku uključivat će upozorenje u kojem se navode rizici ponovne aktivacije hepatitisa B i koje održava ove preporuke.
English: • The PRAC reviewed the totality of the data submitted in writing and during the oral explanations by the marketing authorisation holders in relation to the risk of hepatitis B reactivation and to the concerns raised following reports of hepatocellular carcinoma in patients using DAAs, as well as the outcome of the meeting of the scientific advisory group on HIV/Viral
Croatian: • PRAC je ocijenio sveukupne pismeno podnesene podatke i usmena objašnjenja nositelja odobrenja za stavljanje lijekova u promet u pogledu rizika za ponovnu aktivaciju hepatitisa B i zabrinutosti koje su proizašle iz izvješća o hepatocelularnom karcinomu u bolesnika koji primjenjuju antivirusne lijekove, kao i rezultate sastanka znanstvene savjetodavne skupine za virusne bolesti / HIV.
English: Overall, the PRAC was of the view that evidence exists of a risk of HBV reactivation in HBV/HCV coinfected patients treated with DAAs and therefore HBV reactivation in co-infected patients should be considered as an important identified risk which should be closely monitored through routine risk
Croatian: PRAC je smatrao da postoje dokazi o riziku ponovne aktivacije HBV-a u bolesnika koji su koinficirani HBV-om/HCV-om i koji se liječe direktno djelujućim antivirusnim lijekovima te bi se stoga ponovna aktivacija HBV-a u koinficiranih bolesnika trebala smatrati važnim utvrđenim rizikom koji bi se trebao pobliže nadzirati tijekom provedbe rutinskih mjera za smanjenje rizika.
English: In accordance with the PRAC recommendation, in order to evaluate the recurrence of hepatocellular carcinoma associated with direct-acting antivirals, the MAHs shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol setting out criteria for entry and follow-up of patients in terms of timing and
Croatian: U skladu s preporukom PRAC-a, MAH-ovi bi za ocjenu povezanosti vraćanja hepatocelularnog karcinoma i primjene direktno djelujućih antivirusnih lijekova trebali provesti prospektivno ispitivanje sigurnosti pomoću podataka iz kohortnog ispitivanja pomno definirane skupine bolesnika na temelju dogovorenog protokola koji utvrđuje kriterije za ulazak i praćenje bolesnika u pogledu vremena i metode probira te podnijeti rezultate tog ispitivanja.
English: EU/1/17/1226/001 LUTATHERA 370 MBq/ml
Croatian: EU/1/17/1226/001 LUTATHERA
English: Content (concentration)
Croatian: Sastav (koncentracija
English: 20.5 - 25 ml
Croatian: U venu bočica (staklena) 20.5 - 25 ml
English: Solution for infusion
Croatian: Otopina za infuziju.
English: Strength Pharmaceutical Form
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Jačina Farmaceutski oblik
English: 1 ml (100 mg/ml) 3 (3 x 1) prefilled syringes (multipack)
Croatian: 1 ml (100 mg/ml) 3 (3 x 1) napunjene štrcaljke (višestruko pakiranje)
English: 1 ml (100 mg/ml) 3 (3 x 1) prefilled pens (multipack)
Croatian: 1 ml (100 mg/ml) 3 (3 x 1) napunjene brizgalice (višestruko pakiranje)
English: 1 ml (100 mg/ml) 1 pre-filled pen
Croatian: 1 ml (100 mg/ml) 1 napunjena brizgalica
English: 1 ml (100 mg/ml) 1 pre-filled syringe
Croatian: 1 ml (100 mg/ml) 1 napunjena štrcaljka
English: It is available as tablets (300 mg/150 mg/300 mg).
Croatian: Dostupan je u tabletama (300 mg/150 mg/300 mg).
English: The recommended dose of Trizivir is one tablet twice a day.
Croatian: Preporučena doza lijeka Trizivir je jedna tableta dvaput na dan.
English: The full EPAR for Trizivir can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Trizivir nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The CHMP noted that the reduction in the number of tablets that patients need to take may help patients stick to their treatment.
Croatian: CHMP je zaključio da smanjenje broja tableta koje bolesnici moraju uzimati može pomoći bolesnicima u pridržavanju terapije.
English: Patients should have been taking the three active substances separately for at least six to eight weeks before switching to Trizivir.
Croatian: Bolesnici trebaju uzimati tri djelatne tvari zasebno najmanje šest do osam tjedana prije prelaska na lijek Trizivir.
English: In patients with high levels of HIV in the blood (above 100,000 copies/ml), the choice of treatment requires special consideration.
Croatian: U bolesnika s visokim koncentracijama HIV-a u krvi (većima od 100,000 kopija/ml) odabir terapije zahtijeva posebnu pozornost.
English: All three active substances have been available in the European Union (EU) for a number of years: abacavir has been authorised as Ziagen since 1999, lamivudine has been authorised as Epivir since 1996, and zidovudine has been available in the EU since the mid-1980s.
Croatian: Sve tri djelatne tvari dostupne su u Europskoj uniji (EU) već niz godina: abakavir je odobren kao Ziagen od 1999., lamivudin je odobren kao Epivir od 1996., a zidovudin je dostupan u EU od sredine 1980.-ih.
English: No specific clinical studies have been carried out to assess the safety and effectiveness of the combined tablet.
Croatian: Nisu provedena posebna klinička ispitivanja s ciljem ocjene sigurne primjene i djelotvornosti kombinirane tablete.
English: Trizivir 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: Trizivir ne liječi infekciju HIV-om niti AIDS, no može odgoditi oštećenje imunosnog sustava i razvoj infekcija i bolesti povezanih s AIDS-om.
English: What measures are being taken to ensure the safe and effective use of Trizivir?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Trizivir?