FrancophonIA/ELRC3.0 huggingface dataset:
English: The effect of some medicines you swallow might be affected by Lyxumia.
Croatian: Lyxumia može utjecati na učinak nekih lijekova koje uzimate kroz usta.
English: Check that the activation window is white.
Croatian: Provjerite je li prozorčić za aktivaciju bijele boje.
English: Each pre-filled pen contains 14 doses, each dose contains 10 micrograms in 0.2 ml.
Croatian: Jedna napunjena brizgalica sadrži 14 doza, a jedna doza sadrži 10 mikrograma u 0,2 ml.
English: Cardiac arrhythmias particularly tachycardia (0.8% vs <0.1%) and palpitations (1.5% vs 0.8%) have been reported in lixisenatide patients compared to placebo treated patients.
Croatian: U bolesnika liječenih liksisenatidom u usporedbi s bolesnicima koji su primali placebo prijavljene su srčane aritmije, osobito tahikardija (0,8% naspram < 0,1%) i palpitacije (1,5% naspram 0,8%).
English: Mean HbA1c (%) Baseline LS mean change from baseline Patients (%) achieving HbA1c <7.0% Mean duration of treatment with basal insulin at baseline (years) Mean change in basal insulin dose (U) Baseline LS mean change from baseline Mean body weight (kg) Baseline LS mean change from baseline *performed in Asian population
Croatian: Srednja vrijednost promjene od početne vrijednosti, metodom najmanjih kvadrata Bolesnici (%) koji su postigli HbA1c < 7,0% 28,3 Srednja vrijednost trajanja liječenja bazalnim inzulinom na početku ispitivanja (godine) Srednja vrijednost promjene doze bazalnog inzulina (U) Početna vrijednost
English: Reversible testicular and epididymal lesions were seen in dogs treated with lixisenatide.
Croatian: U pasa liječenih liksisenatidom primijećene su reverzibilne lezije na testisima i epididimisu.
English: At the end of the 24-week treatment period, 56.3% of the lixisenatide patients achieved an HbA1c less than 7 % compared to 38.5% in the placebo group.
Croatian: Na kraju osnovnog 24-tjednog razdoblja liječenja vrijednost HbA1c manju od 7% postiglo je 56,3% bolesnika na liksisenatidu u usporedbi s 38,5% bolesnika na placebu.
English: Contact your doctor, pharmacist or nurse.
Croatian: Obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: Each pre-filled pen contains 14 doses, each dose contains 20 micrograms in 0.2 ml.
Croatian: Jedna napunjena brizgalica sadrži 14 doza, a jedna doza sadrži 20 mikrograma u 0,2 ml.
English: INFORMATION IN BRAILLE Lyxumia 10
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Lyxumia 10
English: Lyxumia in combination with metformin, a sulphonylurea, pioglitazone or a combination of these agents showed statistically significant reductions in HbA1c, in fasting plasma glucose and in 2-hour post-prandial glucose after a test-meal compared to placebo at the end of the main 24-week treatment period (tables 2 and 3).
Croatian: Na kraju osnovnog 24-tjednog razdoblja liječenja Lyxumia je u kombinaciji s metforminom, sulfonilurejom, pioglitazonom ili kombinacijom tih lijekova dovela do statistički značajnih smanjenja HbA1c, glukoze u plazmi natašte i glukoze postprandijalno 2 sata nakon testnog obroka u usporedbi s placebom (Tablice 2 i 3).
English: • Replace the pen cap before you throw away your Lyxumia pen.
Croatian: • Vratite zatvarač na Lyxumia brizgalicu prije nego što je bacite.
English: Each pen contains a different strength of Lyxumia.
Croatian: Obje brizgalice sadrže lijek Lyxumia, ali različitih jačina.
English: Pack size of 1 pre-filled pen.
Croatian: Veličina pakiranja: 1 napunjena brizgalica.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Lyxumia 10 micrograms solution for injection Each dose (0.2 ml) contains 10 micrograms (mcg) of lixisenatide (50 mcg per ml).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Lyxumia 10 mikrograma otopina za injekciju Jedna doza (0,2 ml) sadrži 10 mikrograma (µg) liksisenatida (50 µg po ml).
English: Begin with the green 10 microgram Lyxumia pen.
Croatian: Počnite sa zelenom Lyxumia brizgalicom od 10 mikrograma.
English: • The green pen contains 14 pre-set doses; each dose contains 10 micrograms of Lyxumia.
Croatian: • Zelena brizgalica sadrži 14 prethodno odmjerenih doza; jedna doza sadrži 10 mikrograma lijeka
English: - you have type 1 diabetes or diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin) since this medicine will not be right for you
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite lijek Lyxumia ako: - imate šećernu bolesti tipa 1 ili dijabetičku ketoacidozu (komplikaciju šećerne bolesti koja se javlja kada tijelo ne može razgraditi glukozu jer nema dovoljno inzulina), jer ovaj lijek nije prikladan za Vas - imate ili ste imali upalu gušterače (pankreatitis) - imate teški problem sa želucem ili crijevima, poput bolesti mišića želuca koja se zove
English: in case of vomiting, nausea and diarrhoea.
Croatian: - dođe do gubitka tekućine/dehidracije, npr. u slučaju povraćanja, mučnine i proljeva.
English: Mean HbA1c (%) Baseline
Croatian: Srednja vrijednost HbA1c (%) Početna vrijednost
English: Patients with hepatic impairment No dose adjustment is needed in patients with hepatic impairment (see section 5.2).
Croatian: Nije potrebna prilagodba doze u bolesnika s oštećenjem funkcije jetre (vidjeti dio 5.2).
English: - Lyxumia 10 micrograms solution for injection: Each dose contains 10 micrograms of lixisenatide (50 micrograms per ml).
Croatian: - Lyxumia 10 mikrograma otopina za injekciju: jedna doza sadrži 10 mikrograma liksisenatida (50 mikrograma po ml).
English: • Talk with your doctor, pharmacist or nurse about how to inject correctly before using it.
Croatian: • Prije uporabe brizgalice razgovarajte sa svojim liječnikom, ljekarnikom ili medicinskom sestrom o tome kako pravilno injicirati lijek.
English: When Lyxumia was given with a sulphonylurea and a basal insulin, symptomatic hypoglycaemia occurred in 47.2% of lixisenatide treated patients compared to 21.6% with placebo (25.6% absolute difference).
Croatian: Kada se Lyxumia primjenjivala u kombinaciji sa sulfonilurejom i bazalnim inzulinom, simptomatska hipoglikemija javila se u 47,2% bolesnika liječenih liksisenatidom i u 21,6% bolesnika koji su primali placebo (apsolutna razlika 25,6%).
English: Lyxumia pen Information
Croatian: Informacije o Lyxumia brizgalici
English: What you need to know before you use Lyxumia
Croatian: Što je Lyxumia i za što se koristi Što morate znati prije nego počnete primjenjivati lijek Lyxumia Kako primjenjivati lijek Lyxumia Moguće nuspojave
English: Treatment with Lyxumia in combination with metformin and/or a sulphonylurea resulted in a sustained body weight change from baseline in all controlled studies in a range from -1.76 kg to2.96 kg at the end of the main 24-week treatment period.
Croatian: Na kraju glavnog 24-tjednog razdoblja liječenja u svim kontroliranim ispitivanjima liječenje lijekom Lyxumia u kombinaciji s metforminom i/ili sulfonilurejom rezultiralo je održanom promjenom tjelesne težine u odnosu na početne vrijednosti koja se kretala u rasponu od -1,76 kg do -2,96 kg.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/811/005 (1 pre-filled pen + 1 pre-filled pen)
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/811/005 (1 napunjena brizgalica + 1 napunjena brizgalica)
English: One purple 20 microgram pen (Lyxumia 20 micrograms solution for injection), each dose contains 20 micrograms in 0.2 ml.
Croatian: Jedna ljubičasta brizgalica od 20 mikrograma (Lyxumia 20 mikrograma otopina za injekciju), svaka doza sadrži 20 mikrograma u 0,2 ml.
English: The reductions in fasting plasma glucose obtained with Lyxumia treatment ranged from 0.42 mmol/L to 1.19 mmol/L (7.6 to 21.4 mg/dl) from baseline at the end of the main 24-week treatment period in placebo-controlled studies.
Croatian: Na kraju 24-tjednog osnovnog razdoblja liječenja u placebom kontroliranim ispitivanjima smanjenje koncentracije glukoze u plazmi natašte postignuto liječenjem lijekom Lyxumia kretalo se u rasponu od 0,42 mmol/l do 1,19 mmol/l (7,6 do 21,4 mg/dl) u odnosu na početne vrijednosti.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each dose (0.2 ml) contains 10 or 20 micrograms lixisenatide.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna doza (0,2 ml) sadrži 10 ili 20 mikrograma liksisenatida.
English: Lyxumia is to be injected subcutaneously in the thigh, abdomen or upper arm. Lyxumia should not be administered intravenously or intramuscularly.
Croatian: Lyxumia se ne smije primjenjivati intravenski ili intramuskularno.
English: Each green pen of Lyxumia 10 micrograms solution for injection contains 3 ml of solution , delivering 14 doses of 10 micrograms.
Croatian: Jedna zelena brizgalica lijeka Lyxumia 10 mikrograma otopina za injekciju sadrži 3 ml otopine, za primjenu 14 doza od 10 mikrograma.
English: - Lyxumia 20 micrograms solution for injection: Each dose contains 20 micrograms of lixisenatide (100 micrograms per ml).
Croatian: - Lyxumia 20 mikrograma otopina za injekciju: jedna doza sadrži 20 mikrograma liksisenatida (100 mikrograma po ml).
English: Squeeze the outer needle cap to grip the needle and use it to unscrew the needle from the pen.
Croatian: Stisnite vanjski zatvarač igle kako biste čvrsto uhvatili iglu i uz pomoć zatvarača odvijte iglu s brizgalice.
English: During the entire treatment period, when Lyxumia was given with a sulphonylurea alone, symptomatic hypoglycaemia occurred in 22.7% of lixisenatide treated patients versus 15.2% with placebo (7.5% absolute difference).
Croatian: Kada se Lyxumia primjenjivala u kombinaciji samo sa sulfonilurejom, simptomatska hipoglikemija se tijekom cijelog razdoblja liječenja javila u 22,7% bolesnika liječenih liksisenatidom i u 15,2% bolesnika koji su primali placebo (apsolutna razlika 7,5%).
English: In patients taking Lyxumia in combination with a sulphonylurea and metformin, symptomatic hypoglycaemia occurred in 22.0% of lixisenatide treated patients and in 18.4% of placebo treated patients during the entire treatment period (3.6% absolute difference).
Croatian: Kada se Lyxumia primjenjivala u kombinaciji sa sulfonilurejom i metforminom, simptomatska hipoglikemija se tijekom cijelog razdoblja liječenja javila u 22,0% bolesnika liječenih liksisenatidom i u 18,4% bolesnika koji su primali placebo (apsolutna razlika 3,6%).
English: Each green pre-filled pen contains 3 ml solution, delivering 14 doses of 10 mcg.
Croatian: Jedna zelena napunjena brizgalica sadrži 3 ml otopine, za primjenu 14 doza od 10 µg.
English: The treatment initiation pack contains one green pen of Lyxumia 10 micrograms solution for injection and one purple pen of Lyxumia 20 micrograms solution for injection.
Croatian: Pakiranje za početak liječenja sadrži jednu zelenu brizgalicu s lijekom Lyxumia 10 mikrograma otopina za injekciju i jednu ljubičastu brizgalicu s lijekom Lyxumia 20 mikrograma otopina za injekciju.
English: Read the Instructions for Use carefully before using your Lyxumia pen.
Croatian: Prije uporabe Lyxumia brizgalica pažljivo pročitajte Upute za uporabu.
English: Pack containing 1 green pre-filled pen of Lyxumia 10 micrograms solution for injection and 1 purple pre-filled pen of Lyxumia 20 micrograms solution for injection.
Croatian: Pakiranje sadrži 1 zelenu napunjenu brizgalicu s lijekom Lyxumia 10 mikrograma otopina za injekciju i 1 ljubičastu napunjenu brizgalicu s lijekom Lyxumia 20 mikrograma otopina za injekciju.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Lyxumia 10 mcg injection
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Lyxumia 10 µg injekcija liksisenatid
English: Ethnic origin had no clinically relevant effect on the pharmacokinetics of lixisenatide based on the results of pharmacokinetic studies in Caucasian, Japanese and Chinese subjects.
Croatian: S obzirom na rezultate farmakokinetičkih ispitivanja provedenih s ispitanicima bijele rase te japanskog i kineskog podrijetla, etničko podrijetlo nema klinički značajan učinak na farmakokinetiku liksisenatida.
English: Section 3 - DAILY USE OF PEN
Croatian: Dio 4 - PRELAZAK NA LJUBIČASTU BRIZGALICU
English: INFORMATION IN BRAILLE Lyxumia
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Lyxumia
English: Lyxumia 20 micrograms solution for injection Each dose (0.2 ml) contains 20 micrograms (mcg) of lixisenatide (100 mcg per ml).
Croatian: Lyxumia 20 mikrograma otopina za injekciju Jedna doza (0,2 ml) sadrži 20 mikrograma (µg) liksisenatida (100 µg po ml).
English: Preferably inject Lyxumia before the same meal every day, when you have chosen the most convenient meal for your injection.
Croatian: Nakon što ste odabrali najprikladniji obrok za injekciju, poželjno je injicirati lijek Lyxumia prije istog obroka svaki dan.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each dose (0.2 ml) contains 10 micrograms lixisenatide (50 micrograms per ml).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna doza (0,2 ml) sadrži 10 mikrograma liksisenatida (50 mikrograma po ml).
English: Adverse reactions reported from placebo- and active-controlled phase III studies over the entire treatment period are presented in Table 1.
Croatian: Tablici 1 navode se nuspojave prijavljene tijekom cijeloga razdoblja liječenja u ispitivanjima faze III kontroliranim placebom ili aktivnim kontrolnim lijekom.
English: Put the outer needle cap back on.
Croatian: Vratite vanjski zatvarač igle na iglu.
English: Each purple pen of Lyxumia 20 micrograms solution for injection contains 3 ml of solution , delivering 14 doses of 20 micrograms.
Croatian: Jedna ljubičasta brizgalica lijeka Lyxumia 20 mikrograma otopina za injekciju sadrži 3 ml otopine, za primjenu 14 doza od 20 mikrograma.
English: For the starting dose Lyxumia 10 micrograms solution for injection is available.
Croatian: Za početnu je dozu dostupnaLyxumia 10 mikrograma otopina za injekciju.
English: Click secs
Croatian: Klik sek
English: Each purple pre-filled pen contains 3 ml solution, delivering 14 doses of 20 mcg.
Croatian: Jedna ljubičasta napunjena brizgalica sadrži 3 ml otopine, za primjenu 14 doza od 20 µg.
English: Use of purple 20 micrograms pen
Croatian: Uporaba ljubičaste brizgalice od 20 mikrograma
English: The incidence of treatment discontinuation due to adverse events was 7.4% for Lyxumia compared to 3.2% in the placebo group during the main 24-week treatment period.
Croatian: Tijekom osnovnog 24-tjednog razdoblja liječenja incidencija prekida liječenja zbog nuspojava iznosila je 7,4% u skupini liječenoj lijekom Lyxumia u usporedbi s 3,2% u skupini koja je primala placebo.
English: Mean systolic and diastolic blood pressure reductions up to 2.1 mmHg and up to 1.5 mmHg respectively were observed in phase III placebo-controlled studies.
Croatian: U placebom kontroliranim ispitivanjima faze III opažena su sniženja srednje vrijednosti sistoličkog krvnog tlaka do 2,1 mmHg te sniženje srednje vrijednosti dijastoličkog krvnog tlaka do 1,5 mmHg.
English: Guide the needle into the outer needle cap.
Croatian: Uvedite iglu u vanjski zatvarač igle.
English: Concomitant medicinal products
Croatian: Istodobna primjena drugih lijekova
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each dose (0.2 ml) contains 20 micrograms lixisenatide (100 micrograms per ml).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna doza (0,2 ml) sadrži 20 mikrograma liksisenatida (100 mikrograma po ml).
English: Read these instructions carefully before using your Lyxumia pens.
Croatian: Prije uporabe Lyxumia brizgalice pažljivo pročitajte ove upute.
English: Use 29 to 32 gauge disposable pen needles with your Lyxumia pen.
Croatian: S Lyxumia brizgalicom upotrebljavajte jednokratne igle za brizgalicu veličine 29 do 32 G.
English: Section 4 - MOVING TO THE PURPLE PEN Completed use of the green 10 microgram pen
Croatian: Završena uporaba zelene brizgalice od 10 mikrograma
English: About Your Lyxumia pens Green 10 microgram Lyxumia pen
Croatian: O Lyxumia brizgalicama Zelena Lyxumia brizgalica od 10 mikrograma
English: Injections site reactions were reported in 3.9% of the patients receiving Lyxumia while they were reported in 1.4% of patients receiving placebo during the main 24-week treatment period.
Croatian: Tijekom osnovnog 24-tjednog razdoblja liječenja reakcije na mjestu injekcije prijavljene su u 3,9% bolesnika liječenih lijekom Lyxumia i u 1,4% bolesnika koji su primali placebo.
English: - you have severe kidney disease or you are on dialysis as the use of this medicine will not be recommended
Croatian: “gastropareza”, a ima za posljedicu odgođeno pražnjenje želuca - imate tešku bolest bubrega ili ste na dijalizi, jer se u tom slučaju ne preporučuje primjena ovoga lijeka
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Lyxumia 20 mcg injection
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Lyxumia 20 µg injekcija liksisenatid
English: NAME OF THE MEDICINAL PRODUCT Treatment initiation pack Lyxumia 10 micrograms solution for injection Lyxumia 20 micrograms solution for injection
Croatian: Pakiranje za početak liječenja Lyxumia 10 mikrograma otopina za injekciju Lyxumia 20 mikrograma otopina za injekciju
English: Activation window
Croatian: Datum aktivacije
English: Lyxumia 10 micrograms solution for injection Lyxumia 20 micrograms solution for injection lixisenatide
Croatian: Lyxumia 10 mikrograma otopina za injekciju Lyxumia 20 mikrograma otopina za injekciju liksisenatid
English: Lyxumia 20 micrograms solution for injection Lixisenatide
Croatian: Lyxumia 20 mikrograma otopina za injekciju liksisenatid
English: Lixisenatide
Croatian: Liksisenatid
English: Dose scale
Croatian: Baciti klik
English: Purple 20 microgram Lyxumia pen
Croatian: Ljubičasta Lyxumia brizgalica od 20 mikrograma
English: Injection button
Croatian: Izvucite dugme za injiciranje
English: This is more likely to happen if you also take a sulphonylurea or a basal insulin.Your doctor may reduce your dose of these medicines before you start using Lyxumia.
Croatian: Liječnik može smanjiti dozu tih lijekova prije nego što počnete primjenjivati lijek Lyxumia.
English: Lyxumia 10 micrograms solution for injection
Croatian: Lyxumia 10 mikrograma otopina za injekciju liksisenatid
English: Table 4: Placebo-controlled studies in combination with a basal insulin (24-week results) Basal insulin as background therapy Alone or in combination with metformin
Croatian: Tablica 4: Placebom kontrolirana ispitivanja u kombinaciji s bazalnim inzulinom (rezultati nakon 24 tjedna)
English: Keep
Croatian: Čuvanje
English: Mean HbA1c (%) Baseline LS mean change from baseline Patients (%) achieving HbA1c
Croatian: Srednja vrijednost promjena od početne vrijednosti dobivena metodom najmanjih kvadrata Bolesnici (%) koji su postigli HbA1c < 7,0%
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/811/001 - 1 pen
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/811/001 - 1 brizgalica
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/811/005 - 2 pens
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/811/005 -2 brizgalice
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/811/002 - 1 pen
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/811/002 - 1 brizgalica
English: Frequency of occurrence
Croatian: Srčana frekvencija
English: Mean HbA1c (%) LS change from baseline LS mean difference (SE) of lixisenatide versus 95% CI
Croatian: Srednja vrijednost HbA1c (%) Promjena od početne vrijednosti, metodom najmanjih kvadrata
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide solution (for pH adjustment) Water for injections
Croatian: 6.1 Popis pomoćnih tvari glicerol 85% natrijev acetat trihidrat metionin metakrezol kloridna kiselina (za podešavanje pH) otopina natrijevog hidroksida (za podešavanje pH) voda za injekcije
English: LS change from baseline LS mean difference (SE) of lixisenatide versus 95% CI
Croatian: Srednja vrijednost razlike (standardna pogreška) liksisenatida naspram 95%-tnog intervala pouzdanosti, metodom najmanjih kvadrata
English: Step B. Attach a new needle and remove the needle caps
Croatian: Pričvrstite novu iglu i uklonite zatvarače igle
English: Step A. Pull off the pen cap and check the pen
Croatian: Skinite zatvarač brizgalice i pregledajte brizgalicu
English: Patients (%) achieving HbA1c <7.0% Mean body weight (kg) Baseline
Croatian: Srednja vrijednost promjene od početne vrijednosti dobivena metodom najmanjih kvadrata Bolesnici (%) koji su postigli HbA1c < 7,0%
English: NAME OF THE MEDICINAL PRODUCT Lyxumia 10 micrograms solution for injection Lyxumia 20 micrograms solution for injection
Croatian: Lyxumia 10 mikrograma otopina za injekciju Lyxumia 20 mikrograma otopina za injekciju
English: After concomitant administration of lixisenatide 20 mcg and digoxin 0.25 mg at steady state, the AUC of digoxin was not affected.
Croatian: Istodobna primjena liksisenatida u dozi od 20 µg i digoksina u dozi od 0,25 mg u stanju dinamičke ravnoteže nije utjecala na AUC digoksina. tmax digoksina odgodio se za 1,5 sati, a Cmax se smanjio za
English: EXPIRY DATE
Croatian: Datum zbrinjavanja
English: Darunavir Mylan is available as tablets (75, 150, 300, 400, 600 and 800 mg).
Croatian: Darunavir Mylan dostupan je u obliku tableta (75, 150, 300, 600 i 800 mg).
English: The full EPAR for Darunavir Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Darunavir Mylan nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: When the enzyme is blocked, the virus does not reproduce normally, slowing down its multiplication in the body.
Croatian: Kada je enzim blokiran, virus se ne razmnožava na uobičajen način, što usporava njegovu stopu replikacije u tijelu.
English: Darunavir Mylan may be given to adults or children from 3 years of age and weighing at least 15 kg.
Croatian: Darunavir Mylan može se dati odraslim osobama ili djeci starijoj od 3 godine čija je tjelesna težina najmanje 15 kg.
English: Previously treated patients can also take a dose of 800 mg once a day provided that their HIV infection is well controlled and is not likely to be resistant to darunavir.
Croatian: Prethodno liječeni bolesnici mogu primiti i dozu od 800 mg jedanput na dan, pod uvjetom da je njihova infekcija HIV-om dobro kontrolirana i da je izgledno kako nisu rezistentni na darunavir.
English: This means that Darunavir Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Prezista.
Croatian: To znači da Darunavir Mylan sadrži istu djelatnu tvar i djeluje na isti način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU) pod nazivom Prezista.
English: The company also carried out studies that showed that it is ‘bioequivalent' to the reference medicine.
Croatian: Tvrtka je provela i studije koje su pokazale da je lijek „bioekvivalentan” referentnom lijeku.
English: As for every medicine, the company provided studies on the quality of Darunavir Mylan.
Croatian: Kao i za svaki lijek, tvrtka je dostavila studije o kvaliteti lijeka Darunavir Mylan.
English: The medicine is always taken either with cobicistat (in adults) or with low-dose ritonavir (in adults and children) and with other HIV medicines, and should be taken with food.
Croatian: Lijek se uvijek uzima s kobicistatom (u odraslih osoba) ili niskom dozom ritonavira (u odraslih osoba i djece) te s drugim lijekovima za liječenje infekcije HIV-om, a uzima se uz obrok.
English: The Committee recommended that Darunavir Mylan be approved for use in the EU.
Croatian: Odbor je preporučio izdavanje odobrenja za lijek Darunavir Mylan za upotrebu u EU-u.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Darunavir Mylan has been shown to have comparable quality and to be bioequivalent to Prezista.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, Darunavir Mylan dokazao usporedivu kakvoću te da je bioekvivalentan lijeku Prezista.