FrancophonIA/ELRC3.0 huggingface dataset:
English: Mixtard 40 Penfill 100 IU/ml Suspension for injection in cartridge Insulin human
Croatian: Mixtard 40 Penfill 100 IU/ml Suspenzija za injekciju u ulošku humani inzulin
English: Package leaflet: Information for the user Mixtard 30 100 IU/ml (international units/ml) suspension for injection in vial human insulin
Croatian: Uputa o lijeku: Informacije za korisnika Mixtard 30 100 IU/ml (internacionalnih jedinica/ml) suspenzija za injekciju u bočici humani inzulin
English: Package leaflet: Information for the user Mixtard 40 Penfill 100 IU/ml (international units/ml) suspension for injection in cartridge human insulin
Croatian: Uputa o lijeku: Informacije za korisnika Mixtard 40 Penfill 100 IU/ml (internacionalnih jedinica/ml) suspenzija za injekciju u ulošku humani inzulin
English: Package leaflet: Information for the user Mixtard 30 FlexPen 100 IU/ml (international units/ml) suspension for injection in pre-filled pen human insulin
Croatian: Uputa o lijeku: Informacije za korisnika Mixtard 30 FlexPen 100 IU/ml (internacionalnih jedinica/ml) suspenzija za injekciju u napunjenoj brizgalici humani inzulin
English: Mixtard contains less than 1 mmol sodium (23 mg) per dose, i.e. Mixtard is essentially ‘sodium-free'.
Croatian: Mixtard sadrži natrij Mixtard sadrži manje od 1 mmol (23 mg) natrija po dozi, tj.
English: Mixtard 30 vial (40 international units/ml)/Mixtard 30 vial (100 international units/ml) Vial (type 1 glass) closed with a disc (bromobutyl/polyisoprene rubber) and a protective tamper-proof plastic cap containing 10 ml of suspension.
Croatian: Mixtard 30 bočica (100 internacionalnih jedinica/ml) 1 bočica sadrži 10 ml što odgovara 1000 internacionalnih jedinica.
English: Mixtard 30 InnoLet 100 IU/ml Suspension for injection in pre-filled pen Insulin human
Croatian: Mixtard 30 InnoLet 100 IU/ml Suspenzija za injekciju u napunjenoj brizgalici humani inzulin
English: EU/1/02/231/033 1 pen of 3 ml EU/1/02/231/034 5 pens of 3 ml EU/1/02/231/035 10 pens of 3 ml
Croatian: EU/1/02/231/034 5 brizgalica od 3 ml
English: Package leaflet: Information for the user Mixtard 30 Penfill 100 IU/ml (international units/ml) suspension for injection in cartridge human insulin
Croatian: Uputa o lijeku: Informacije za korisnika Mixtard 30 Penfill 100 IU/ml (internacionalnih jedinica/ml) suspenzija za injekciju u ulošku humani inzulin
English: Package leaflet: Information for the user Mixtard 30 InnoLet 100 IU/ml (international units/ml) suspension for injection in pre-filled pen human insulin
Croatian: Uputa o lijeku: Informacije za korisnika Mixtard 30 InnoLet 100 IU/ml (internacionalnih jedinica/ml) suspenzija za injekciju u napunjenoj brizgalici humani inzulin
English: EU/1/02/231/037 5 packs of 1 x 10 ml vial
Croatian: EU/1/02/231/018 5 uložaka od 3 ml
English: Mixtard 40 Penfill 100 IU/ml Suspension for injection Insulin human
Croatian: Mixtard 40 Penfill 100 IU/ml Suspenzija za injekciju humani inzulin s.c.
English: EU/1/02/231/001 1 vial of 10 ml EU/1/02/231/002 5 vials of 10 ml
Croatian: EU/1/02/231/002 5 bočica od 5 ml
English: Mixtard 30 InnoLet 100 IU/ml Suspension for injection Insulin human
Croatian: Mixtard 30 InnoLet 100 IU/ml Suspenzija za injekciju humani inzulin s.c.
English: Mixtard 30 Penfill 100 IU/ml Suspension for injection Insulin human
Croatian: Mixtard 30 Penfill 100 IU/ml Suspenzija za injekciju humani inzulin s.c.
English: Pharmacotherapeutic group: Drugs used in diabetes.
Croatian: Pioglitazon (tablete za liječenje šećerne bolesti tipa 2)
English: EU/1/02/231/011 1 cartridge of 3 ml EU/1/02/231/012 5 cartridges of 3 ml EU/1/02/231/013 10 cartridges of 3 ml
Croatian: EU/1/02/231/013 10 uložaka od 3 ml
English: EU/1/02/231/030 1 pen of 3 ml EU/1/02/231/031 5 pens of 3 ml EU/1/02/231/032 10 pens of 3 ml
Croatian: EU/1/02/231/032 10 brizgalica od 3 ml
English: EU/1/02/231/017 1 cartridge of 3 ml EU/1/02/231/018 5 cartridges of 3 ml EU/1/02/231/019 10 cartridges of 3 ml
Croatian: EU/1/02/231/019 10 uložaka od 3 ml
English: Doses are adjusted as necessary.
Croatian: Doze se prilagođavaju prema potrebi.
English: Metformin has been available in the EU since the 1950s.
Croatian: Metformin je dostupan u EU-u od 1950-ih godina.
English: This summary was last updated in 02-2017.
Croatian: Ovaj sažetak je posljednji put ažuriran u 02. 2017.
English: The full EPAR and risk management plan summary for Synjardy can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Synjardy, kao i plan upravljanja rizikom, nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Synjardy and what is it used for?
Croatian: Što je Synjardy i za što se koristi?
English: In addition, the results indicated that the combination was associated with a beneficial decrease in body weight and blood pressure.
Croatian: Nadalje, rezultati ukazuju na to da je ta kombinacija povezana s korisnim snižavanjem tjelesne težine i krvnog tlaka.
English: Why is Synjardy approved?
Croatian: Zašto je Synjardy odobren?
English: This leads to a high level of glucose in the blood.
Croatian: To dovodi do visoke razine glukoze u krvi.
English: What measures are being taken to ensure the safe and effective use of Synjardy?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Synjardy?
English: The main measure of effectiveness was the occurrence of one of three major cardiovascular events: stroke, heart attack or death caused by cardiovascular disease.
Croatian: Glavna mjera djelotvornosti bila je prva pojava jednoga od tri glavna kardiovaskularna događaja: moždanog udara, srčanog udara ili smrti izazvane kardiovaskularnom bolešću.
English: • liver impairment, or problems with alcoholism or alcohol intoxication.
Croatian: • oštećenja jetre ili problema s alkoholizmom ili alkoholnom intoksikacijom.
English: Synjardy must not be used in patients with:
Croatian: Synjardy se ne smije koristiti kod bolesnika koji imaju:
English: This is a summary of the European public assessment report (EPAR) for Synjardy.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Synjardy.
English: Similar benefits were seen in the studies regardless of the other diabetes medicines being taken.
Croatian: Slične su koristi uočene u ispitivanjima bez obzira na primjenu drugih lijekova protiv dijabetesa.
English: Empagliflozin has been authorised in the EU under the trade name Jardiance since 2014.
Croatian: Empagliflozin je odobren u EU-u pod zaštićenim imenom Jardiance od 2014. godine.
English: What are the risks associated with Synjardy?
Croatian: Koji su rizici povezani s lijekom Synjardy?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Synjardy on 27 May 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Synjardy na snazi u Europskoj uniji od 27. svibnja 2015.
English: Other information about Synjardy
Croatian: Ostale informacije o lijeku Synjardy
English: Some of these were continuations of the main studies that suggested the benefits of the combination continued with longer therapy.
Croatian: Dio tih ispitivanja bio je nastavak glavnih ispitivanja, što ukazuje na to da su se koristi te kombinacije nastavile s duljom terapijom.
English: The main measure of effectiveness was the reduction in the level of a substance in the blood called glycosylated haemoglobin (HbA1c) after 24 weeks of treatment.
Croatian: Glavna mjera djelotvornosti bilo je smanjenje količine tvari u krvi zvane glikozilirani hemoglobin (HbA1c) nakon 24 tjedna liječenja.
English: • in patients who are already taking metformin and empagliflozin as separate tablets.
Croatian: • u bolesnika koji već uzimaju metformin i empagliflozin kao zasebne tablete.
English: It is not intended to provide practical advice on how to use Synjardy.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Synjardy.
English: • severely reduced kidney function or conditions that could affect the kidneys such as dehydration, severe infection or a steep fall in blood pressure;
Croatian: • ozbiljno smanjenu funkciju bubrega ili stanja koja mogu utjecati na bubrege kao što su dehidracija, teška infekcija ili nagli pad krvnog tlaka;
English: Supportive evidence was provided from several further studies.
Croatian: Dokazi koji govore tome u prilog dostavljeni su iz nekoliko dodatnih ispitivanja.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Synjardy's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Synjardy nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: • metabolic acidosis (when the body produces more acid than it gets rid of) or diabetic pre-coma (dangerous complications of diabetes);
Croatian: • metaboličku acidozu (stanja pri kojem tijelo proizvodi više kiseline nego što je izlučuje) ili dijabetičku pretkomu (opasne komplikacije dijabetesa);
English: The recommended dose of Synjardy is one tablet twice a day with meals, and treatment is normally started with a tablet that supplies the dose of metformin the patient is already taking, together with the lowest dose (5 mg) of empagliflozin.
Croatian: Preporučena doza lijeka Synjardy je jedna tableta dva puta na dan uz obrok, a liječenje se najčešće započinje tabletom koja osigurava dozu metformina koju bolesnik već uzima, zajedno s najmanjom dozom empagliflozina (od 5 mg).
English: In those receiving empagliflozin, cardiovascular events occurred in 10.5% (490 out of 4,687) of patients compared with 12.1% (282 out of 2,333) of patients receiving placebo.
Croatian: Kod bolesnika koji su primali empagliflozin kardiovaskularni događaji nastupili su u 10,5 % (490 od 4 687) bolesnika u usporedbi s 12,1 % (282 od 2 333) bolesnika koji su primali placebo.
English: Synjardy is available as tablets containing 5 or 12.5 mg of empagliflozin with 850 or 1,000 mg of metformin, and can only be obtained with a prescription.
Croatian: Synjardy je dostupan u obliku tableta koje sadrže 5 ili 12,5 mg empagliflozina s 850 ili 1 000 mg metformina, a izdaje se samo na recept.
English: Overall, the additional reduction was 0.58 percentage points with a combination providing 5 mg of empagliflozin twice daily, and 0.62 percentage points with the 12.5 mg dose, and these reductions were considered clinically relevant.
Croatian: Ukupno gledajući, dodatno smanjenje iznosilo je 0,58 postotnih bodova u kombinaciji koja je osiguravala 5 mg empagliflozina dva puta dnevno i 0,62 postotna boda s dozom od 12,5 mg, a ta su smanjenja smatrana klinički relevantnima.
English: Among these, in patients who were also taking metformin (the other active substance in Synjardy), the three major cardiovascular events occurred in 9.9% (344 out of 3,459) of patients receiving empagliflozin and in 10.9% (189 out of 1,734) of patients receiving placebo.
Croatian: Među njima, u bolesnika koji su uzimali i metformin (drugu djelatnu tvar lijeka Synjardy), tri glavna kardiovaskularna događaja nastupila su u 9,9 % (344 od 3 459) bolesnika koji su primali empagliflozin i u 10,9 % (189 od 1 734) bolesnika koji su primali placebo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Synjardy 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 Synjardy nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The CHMP concluded that the medicine could help produce a clinically meaningful reduction in blood glucose in patients with type 2 diabetes, and the benefits and risks were in line with those of the individual active substances.
Croatian: CHMP je zaključio da lijek može pomoći u stvaranju klinički značajnog smanjenja razine glukoze u krvi u bolesnika s dijabetesom tipa 2 te su koristi i rizici bili u skladu s onima pojedinačno aktivnih tvari.
English: The benefits of empagliflozin in combination with metformin have been shown in 3 main studies involving 1,679 patients with type 2 diabetes whose blood sugar was not adequately controlled by metformin, alone or combined with other diabetes medicines (such as pioglitazone or a type of diabetes medicine called a sulphonylurea).
Croatian: Koristi empagliflozina u kombinaciji s metforminom utvrđene su u trima glavnim ispitivanjima kojima je obuhvaćeno 1 679 bolesnika s dijabetesom tipa 2 čije razine šećera u krvi nisu primjereno kontrolirane metforminom koji se uzima kao monoterapija ili u kombinaciji s drugim lijekovima protiv dijabetesa (poput pioglitazona ili vrste lijeka protiv dijabetesa naziva sulfonilureja).
English: If Synjardy is used in combination with insulin or a sulphonylurea (a medicine that increases the body's production of insulin), the doses of these medicines may need to be lowered to avoid hypoglycaemia (low blood sugar levels).
Croatian: Ako se Synjardy koristi u kombinaciji s inzulinom ili sulfonilurejom (lijekom koji povećava stvaranje inzulina u tijelu), doze tih lijekova možda će biti potrebno smanjiti kako bi se izbjegla hipoglikemija (niska razina šećera u krvi).
English: Synjardy is used:
Croatian: Lijek Synjardy primjenjuje se:
English: What benefits of Synjardy have been shown in studies?
Croatian: Koje su koristi lijeka Synjardy dokazane u ispitivanjima?
English: The study involved patients with type 2 diabetes who already had cardiovascular disease (such as angina, heart attack and stroke).
Croatian: U to su ispitivanje bili uključeni bolesnici s dijabetesom tipa 2 koji su već bolovali od kardiovaskularnih bolesti (npr. angina te srčani i moždani udar).
English: Metformin works mainly by reducing the production of glucose in the body and reducing its absorption from the gut.
Croatian: Metformin uglavnom djeluje tako da smanjuje stvaranje glukoze u tijelu i smanjuje njezinu apsorpciju iz crijeva.
English: • a condition that could reduce the supply of oxygen to body tissues (such as in patients with worsening heart failure, recent heart attack, breathing difficulty or a steep fall in blood pressure);
Croatian: • stanja koje može rezultirati smanjenom opskrbom tjelesnih tkiva kisikom (primjerice u bolesnika sa zatajenjem srca čije se stanje pogoršava, u bolesnika koji su nedavno imali srčani udar, u bolesnika s otežanim disanjem ili naglim padom krvnog tlaka);
English: Empagliflozin works by blocking a protein in the kidneys (called sodium-glucose co-transporter 2 or SGLT2).
Croatian: Empagliflozin djeluje blokiranjem proteina u bubrezima (naziva kotransporter 2 natrija i glukoze (SGLT2)).
English: • in patients whose diabetes is not sufficiently controlled by metformin alone;
Croatian: • u bolesnika kod kojih se ne može postići dovoljna kontrola dijabetesa samo metforminom;
English: For more information about treatment with Synjardy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Synjardy pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Another main study showed that adding empagliflozin (one of the active substances of Synjardy) to usual treatment reduced adverse cardiovascular (heart and blood vessels) effects.
Croatian: U drugom glavnom ispitivanju pokazalo se da su se dodavanjem empagliflozina (jedne od djelatnih tvari lijeka Synjardy) uobičajenoj terapiji smanjili nepovoljni kardiovaskularni učinci (na srce i krvne žile).
English: In type 2 diabetes the body does not make enough insulin to control the level of glucose (sugar) in the blood or the body is unable to use insulin effectively.
Croatian: Dijabetes tipa 2 bolest je pri kojoj tijelo ne proizvodi dovoljno inzulina za kontrolu razine glukoze (šećera) u krvi ili pri kojoj tijelo ne može učinkovito iskoristiti inzulin.
English: For practical information about using Synjardy, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Synjardy bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: The two active substances in Synjardy, empagliflozin and metformin, work in different ways to lower blood glucose, and thus to control symptoms of the disease.
Croatian: Dvije djelatne tvari lijeka Synjardy, empagliflozin i metformin, na različite načine djeluju na smanjenje glukoze u krvi, čime se postiže kontrola simptoma bolesti.
English: • in combination with other diabetes medicines in patients whose diabetes is not sufficiently controlled on these medicines plus metformin;
Croatian: • u kombinaciji s drugim lijekovima protiv dijabetesa u bolesnika kod kojih nije postignuta dovoljna kontrola dijabetesa navedenim lijekovima i metforminom;
English: Because of concerns about the balance of benefit and risk in patients with reduced kidney function taking the fixed-dose combination, the CHMP recommended restricting its use in these patients.
Croatian: Postojala je određena zabrinutost u pogledu omjera koristi i rizika u bolesnika sa smanjenom funkcijom bubrega koji su uzimali kombinaciju fiksne doze te je CHMP preporučio ograničavanje primjene lijeka kod tih bolesnika.
English: Synjardy was also shown to reduce cardiovascular events in patients with type 2 diabetes who already had cardiovascular disease.
Croatian: Usto, pokazalo se da se primjenom lijeka Synjardy smanjuje učestalost kardiovaskularnih događaja kod bolesnika s dijabetesom tipa 2 koji su već bolovali od kardiovaskularnih bolesti.
English: It contains the active substances empagliflozin and metformin.
Croatian: Sadrži djelatne tvari empagliflozin i metformin.
English: Synjardy is a diabetes medicine used with diet and exercise to treat adults with type 2 diabetes.
Croatian: Synjardy je lijek protiv dijabetesa koji se koristi uz dijetu i tjelovježbu za liječenje odraslih osoba oboljelih od dijabetesa tipa
English: Studies also indicated Synjardy was as effective as empagliflozin and metformin taken separately, and that the combination helped reduce HbA1c when added to treatment including insulin.
Croatian: Ispitivanja su također ukazala na to da je lijek Synjardy bio podjednako djelotvoran kao empagliflozin i metformin koji su se uzimali zasebno te da je kombinacija pomogla u snižavanju glikoziliranog hemoglobina (HbA1c) kada su se dodali terapiji koja je uključivala inzulin.
English: The most common side effects with Synjardy are hypoglycaemia (low blood sugar levels) when the medicine is taken with a sulphonylurea or insulin, infections of the urinary tract and genitals, and increased urination.
Croatian: Najčešće nuspojave lijeka Synjardy su hipoglikemija (niska koncentracija šećera u krvi) ako se lijek uzima sa sulfonilurejom ili inzulinom, infekcije mokraćnog sustava i genitalija te češće mokrenje.
English: How does Synjardy work?
Croatian: Kako djeluje Synjardy?
English: How is Synjardy used?
Croatian: Kako se Synjardy koristi?
English: The studies compared the effect of empagliflozin plus metformin versus placebo (a dummy treatment) with metformin.
Croatian: U ispitivanjima je uspoređeno djelovanje empagliflozina s metforminom u odnosu na placebo (prividno liječenje) s metforminom.
English: By blocking the action of SGLT2, empagliflozin causes more glucose to be removed in the urine, thereby reducing the levels of glucose in the blood.
Croatian: Blokiranjem djelovanja proteina SGLT2, empagliflozin uzrokuje izlučivanje veće količine glukoze putem mokraće, čime se snižava razina glukoze u krvi.
English: The studies showed a greater reduction in HbA1c when empagliflozin plus metformin was given, compared with placebo plus metformin.
Croatian: Ispitivanjima je utvrđeno veće smanjenje glikoziliranog hemoglobina (HbA1c) nakon primjene empagliflozina s metforminom, u usporedbi s primjenom placeba s metforminom.
English: As blood is filtered by the kidneys, SGLT2 stops glucose in the bloodstream from being passed out into the urine.
Croatian: Budući da se krv pročišćava u bubrezima, protein SGLT2 onemogućuje da glukoza iz krvotoka prijeđe u mokraću.
English: For the full list of all side effects reported with Synjardy, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Synjardy potražite u uputi o lijeku.
English: Both active substances have been authorised in the EU since the early 2000s: emtricitabine was authorised as Emtriva in 2003, and tenofovir disoproxil was authorised as Viread in 2002.
Croatian: Obje djelatne tvari odobrene su u EU-u još od ranih 2000-ih: emtricitabin je odobren kao Emriva od 2003. dok je tenofovirdizoproksil odobren kao Viread od 2002.
English: Emtricitabine/Tenofovir disoproxil Zentiva received a marketing authorisation valid throughout the EU on 9 November 2016.
Croatian: Lijek Emtricitabine / Tenofovir disoproxil Zentiva dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 9. studenoga 2016.
English: Further information on Emtricitabine/Tenofovir disoproxil Zentiva can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/emtricitabinetenofovir-disoproxil-zentiva.
Croatian: Više informacija o lijeku Emtricitabine / Tenofovir disoproxil Zentiva dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/emtricitabinetenofovir-disoproxil-zentiva.
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 jest jedna tableta jedanput na dan, te je poželjno da se uzima s hranom.
English: This means that Emtricitabine/Tenofovir disoproxil Zentiva contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Truvada.
Croatian: To znači da Emtricitabine / Tenofovir disoproxil Zentiva sadržava istu djelatnu tvar i djeluje na isti način kao i „referentni lijek” koji je već odobren u EU-u pod nazivom Truvada.
English: In addition it may be used from the age of 12 years in adolescents with HIV that is 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 otpornim na lijekove prve linije ili ih ne mogu primati zbog nuspojava.
English: Healthcare professionals will also receive a brochure and reminder card to hand out to individuals receiving the medicine for pre-exposure prophylaxis.
Croatian: Zdravstveni radnici dobit će i brošuru te karticu s podsjetnikom namijenjenu osobama koje primaju lijek za predekspozicijsku profilaksu.
English: Side effects reported with Emtricitabine/Tenofovir disoproxil Zentiva are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Emtricitabine / Tenofovir disoproxil Zentiva pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: If patients with HIV1 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: Studies on the benefits and risks of the active substances in the authorised uses have already been carried out with the reference medicine, Truvada, and do not need to be repeated for Emtricitabine/Tenofovir disoproxil Zentiva.
Croatian: Ispitivanja koristi i rizika od djelatnih tvari u odobrenoj primjeni već su provedena s referentnim lijekom Truvada i stoga ih nije potrebno ponavljati za Emtricitabine / Tenofovir disoproxil Zentiva.