FrancophonIA/ELRC3.0 huggingface dataset:
English: Praluent 75 mg solution for injection in a pre-filled syringe Praluent 150 mg solution for injection in a pre-filled syringe alirocumab
Croatian: Praluent 75 mg otopina za injekciju u napunjenoj brizgalici Praluent 150 mg otopina za injekciju u napunjenoj brizgalici alirokumab
English: Placebo-controlled phase 3 studies (on background statin) in patients with heterozygous familial hypercholesterolaemia (heFH)
Croatian: Placebom kontrolirana ispitivanja faze 3 (uz osnovnu terapiju statinima) u bolesnika s heterozigotnom obiteljskom hiperkolesterolemijom
English: Each pre-filled syringe contains 75 mg alirocumab in 1 ml solution (75 mg/ml).
Croatian: TVARI Jedna napunjena brizgalica sadrži 75 mg alirokumaba u 1 ml otopine (75 mg/ml).
English: Among the subgroup of patients up-titrated at week 12, an additional 22.8% mean reduction in LDL-C was achieved at week 24.
Croatian: U podskupini bolesnika kojima je u 12. tjednu postupno povećana doza postignuto je dodatno sniženje srednje vrijednosti LDL-C u 24. tjednu od 22,8%.
English: At week 24, the mean percent change from baseline with alirocumab 300 mg Q4W/150 mg Q2W in LDL-C (ITT analysis) was -52.7% compared to -0.3% for placebo.
Croatian: U 24.tjednu, srednji postotak promjene LDL-C od početne vrijednosti uz 300 mg alirokumaba svaka 4 tjedna/150 mg alirokumaba svaka 2 tjedna (ITT analiza) bio je -52,7% u usporedbi s -0,3% za placebo.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1. 4.4 Posebna upozorenja i mjere opreza pri uporabi Alergijske reakcije
English:  Keep holding the pen against your skin after releasing the button • The injection may take up to 20 seconds.
Croatian:  Brizgalicu držite pritisnutom u kožu i nakon što otpustite dugme
English:  Before you remove the needle check the syringe is empty.
Croatian: Prije nego što uklonite brizgalicu, provjerite je li prozorčić postao žut.
English: Do not re-use a pen.
Croatian: Nemojte ponovno upotrijebiti istu brizgalicu.
English:  Throw away syringe and cap
Croatian:  Bacite štrcaljku i zatvarač
English: Dose up-titration of alirocumab to 150 mg Q2W occurred at week 12 in patients with LDL-C ≥70 mg/dL (≥1.81 mmol/L).
Croatian: U 12. tjednu je doza alirokumaba postupno povećana na 150 mg jednom svaka 2 tjedna u bolesnika koji su imali vrijednost LDL-C od ≥70 mg/dl (≥1,81 mmol/l).
English: Sanofi-Aventis Deutschland GmbH Industriepark Hoechst
Croatian: Deutschland Sanofi-Aventis Deutschland GmbH
English: A slightly greater than dose proportional increase was observed, with a 2.1- to 2.7-fold increase in total alirocumab concentrations for a 2-fold increase in dose from 75 mg to 150 mg Q2W.
Croatian: Pri udvostručenju doze sa 75 mg na 150 mg jednom svaka 2 tjedna primijećeno je povećanje neznatno veće od onog proporcionalnoga dozi, uz povećanje ukupnih koncentracija alirokumaba za 2,1 do 2,7 puta.
English: At week 24, the mean percent change from baseline with alirocumab 300 mg Q4W/150 mg Q2W in LDL-C (ITT analysis) was -58.8% compared to -0.1% for placebo.
Croatian: U 24.tjednu srednji postotak promjene od početne vrijednosti LDL-C uz 300 mg alirokumaba svaka 4 tjedna/150 mg svaka 2 tjedna (ITT analiza) bio je -58,8% u usporedbi s -0,1% za placebo.
English: Each pre-filled pen with green button contains 1 ml of solution, delivering one single dose of 75 milligrams.
Croatian: Jedna napunjena brizgalica sa zelenim dugmetom sadrži 1 ml otopine i isporučuje jednu jednokratnu dozu od 75 mg.
English: Mean Percent Change from Baseline in Placebo-Controlled Studies on Background Statin LONG TERM (N=2310)
Croatian: Srednja postotna promjena od početne vrijednosti u placebom kontroliranim ispitivanjima uz osnovnu terapiju statinima
English: At week 24, the mean treatment difference from placebo in LDL-C percent change from baseline was -55.8% (95% CI: -60.0%, -51.6%; p-value: ˂ 0.0001).
Croatian: U 24. tjednu srednja razlika između liječenja i placeba s obzirom na postotnu promjenu vrijednosti LDL-C od početne vrijednosti iznosila je -55,8% (95% CI: -60,0%, -51,6%; p-vrijednost: ˂ 0,0001).
English: Each pre-filled pen with grey button contains 1 ml of solution, delivering one single dose of 150 milligrams.
Croatian: Jedna napunjena brizgalica sa sivim dugmetom sadrži 1 ml otopine i isporučuje jednu jednokratnu dozu od 150 mg.
English: Adverse reactions are presented by system organ class.
Croatian: Nuspojave su navedene prema organskim sustavima.
English: At week 24, the mean treatment difference from ezetimibe in LDL-C percent change from baseline was -30.4% (95% CI: -36.6%, -24.2%; pvalue: ˂0.0001).
Croatian: U 24. tjednu srednja razlika u odnosu na ezetimib s obzirom na postotnu promjenu vrijednosti LDL-C od početne vrijednosti iznosila je -30,4% (95% CI: -36,6%, -24,2%; p-vrijednost: ˂0,0001).
English: At week 24, the mean treatment difference from ezetimibe in LDL-C percent change from baseline was -29.8% (95% CI: -34.4%, -25.3%; p-value: ˂0.0001).
Croatian: U 24. tjednu srednja razlika u odnosu na ezetimib s obzirom na postotnu promjenu vrijednosti LDL-C od početne vrijednosti iznosila je -29,8% (95% CI: -34,4%, -25,3%; p-vrijednost: ˂0,0001).
English: Each single-use pre-filled syringe contains 75 mg alirocumab in 1 ml solution.
Croatian: Jedna napunjena brizgalica za jednokratnu uporabu sadrži 75 mg alirokumaba u 1 ml otopine.
English: Among the subgroup of patients up-titrated at week 12, an additional 3.6% mean reduction in LDL-C was achieved at week 24.
Croatian: U podskupini bolesnika kojima je u 12. tjednu postupno povećana doza postignuto je dodatno sniženje srednje vrijednosti LDL-C od 3,6% u 24. tjednu.
English: Among the subgroup of patients up-titrated at week 12, an additional 1.4 % mean reduction in LDL-C was achieved at week 24.
Croatian: U podskupini bolesnika kojima je u 12. tjednu postupno povećana doza postignuto je dodatno sniženje srednje vrijednosti LDL-C od 1,4 % u 24. tjednu.
English: Cardiovascular Event e
Croatian: Kardiovaskularna smrt
English: Injection site reactions**
Croatian: Opći poremećaji i reakcije na mjestu primjene reakcije na mjestu injiciranja**
English: Among the subgroup of patients up-titrated at week 12, an additional 10.5% mean reduction in LDL-C was achieved at week 24.
Croatian: U podskupini bolesnika kojima je u 12. tjednu postupno povećana doza postignuto je dodatno sniženje srednje vrijednosti LDL-C od 10,5% u 24. tjednu.
English: At week 24, the mean treatment difference from placebo in LDL-C percent change from baseline was -39.1% (95% CI: -51.1%, -27.1%; p-value: ˂0.0001).
Croatian: U 24. tjednu srednja razlika između liječenja i placeba s obzirom na postotnu promjenu vrijednosti LDL-C od početne vrijednosti iznosila je -39,1% (95% CI: -51,1%, -27,1%; p-vrijednost: ˂0,0001).
English: At week 24, the mean treatment difference from placebo in LDL-C percent change from baseline was -61.9% (95% CI: -64.3%, -59.4%; p-value: ˂0.0001).
Croatian: U 24. tjednu srednja razlika između liječenja i placeba s obzirom na postotnu promjenu vrijednosti LDL-C od početne vrijednosti iznosila je -61,9% (95% CI: -64,3%, -59,4%; p-vrijednost: ˂0,0001).
English: EU/1/15/1031/010 1 pre-filled syringe EU/1/15/1031/011 2 pre-filled syringes EU/1/15/1031/012 6 pre-filled syringes
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1031/010 1 napunjena štrcaljka EU/1/15/1031/011 2 napunjene štrcaljke EU/1/15/1031/012 6 napunjenih štrcaljki
English: sanofi-aventis groupe
Croatian: Nositelj odobrenja za stavljanje lijeka u promet: sanofi-aventis groupe
English: EU/1/15/1031/007 1 pre-filled pen EU/1/15/1031/008 2 pre-filled pens EU/1/15/1031/009 6 pre-filled pens
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1031/007 1 napunjena brizgalica EU/1/15/1031/008 2 napunjene brizgalice EU/1/15/1031/009 6 napunjenih brizgalica
English: Praluent 150 mg solution for injection in a pre-filled syringe alirocumab
Croatian: Praluent 150 mg otopina za injekciju u napunjenoj brizgalici alirokumab
English: In clinical studies, there was limited representation of patients with severe renal impairment (defined as eGFR < 30 mL/min/1.73 m2) (see section 5.2).
Croatian: Praluent treba primjenjivati uz (koje se definiralo kao eGFR <30 ml/min/1,73 m oprez u bolesnika s teškim oštećenjem bubrežne funkcije.
English: Praluent 75 mg solution for injection in pre-filled syringe alirocumab
Croatian: Praluent 75 mg otopina za injekciju u napunjenoj brizgalici alirokumab
English: At week 24, the mean treatment difference from placebo in LDL-C percent change from baseline was -45.9% (95% CI: -52.5%, -39.3%; p-value: ˂0.0001).
Croatian: U 24. tjednu srednja razlika između liječenja i placeba s obzirom na postotnu promjenu vrijednosti LDL-C od početne vrijednosti iznosila je -45,9% (95% CI: -52,5%, -39,3%; p-vrijednost: ˂0,0001).
English: Each single-use pre-filled syringe contains 150 mg alirocumab in 1 ml solution.
Croatian: Jedna napunjena brizgalica za jednokratnu uporabu sadrži 150 mg alirokumaba u 1 ml otopine.
English: EU/1/15/1031/004 1 pre-filled syringe EU/1/15/1031/005 2 pre-filled syringes EU/1/15/1031/006 6 pre-filled syringes
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1031/004 1 napunjena štrcaljka EU/1/15/1031/005 2 napunjene štrcaljke EU/1/15/1031/006 6 napunjenih štrcaljki
English: At week 12 (before up-titration), 77.2% of patients reached an LDL-C of ˂70 mg/dL (˂1.81 mmol/L) as compared to 46.2% in the ezetimibe group.
Croatian: Za detaljne rezultate vidjeti Tablicu 2. Vrijednost LDL-C od <70 mg/dl (<1,81 mmol/l) je u 12. tjednu (prije postupnog povećanja doze) postiglo 77,2% bolesnika liječenih alirokumabom u usporedbi sa 46,2% bolesnika koji su primali ezetimib.
English: Among the subgroup of patients up-titrated at week 12, an additional 15.7% mean reduction in LDL-C was achieved at week 24.
Croatian: U podskupini bolesnika kojima je u 12. tjednu postupno povećana doza postignuto je dodatno sniženje srednje vrijednosti LDL-C u 24. tjednu od 15,7%.
English: OUTER CARTON - Pre-filled pen 75 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Praluent 75 mg
English: BLISTER - Pre-filled syringe 150 mg
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER - Napunjena štrcaljka od 150 mg
English: Patients received either alirocumab 75 mg Q2W or ezetimibe 10 mg once daily.
Croatian: Bolesnici su primali ili alirokumab u dozi od 75 mg jednom svaka 2 tjedna ili ezetimib u dozi od 10 mg jednom dnevno.
English: For detailed results see Table 4.
Croatian: Za postupak prijavljivanja nuspojava, pogledajte dio 4.
English: BLISTER - Pre-filled syringe 75 mg
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER - Napunjena štrcaljka od 75 mg
English: MACE-plus defined as a composite of: coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, or unstable angina (UA) requiring hospitalization b
Croatian: 0,0261f a MACE-plus definirano kao kompozitna mjera ishoda koja se sastoji od: koronarne srčane bolesti, infarkta miokarda bez smrtnog ishoda, ishemijskog moždanog udara s ili bez smrtnog ishoda ili nestabilne angine koja zahtijeva hospitalizaciju b Nestabilna angina koja zahtijeva hospitalizaciju c Događaj koronarne srčane bolesti definiran kao: veliki događaj koronarne srčane bolestid, nestabilna angina koja zahtijeva hospitalizaciju, postupak koronarne revaskularizacije potaknut ishemijom d veliki događaj koronarne srčane bolesti definiran kao: smrt uzrokovana koronarnom srčanom bolesti, infarkt miokarda bez smrtnog ishoda e Kardiovaskularni događaj definiran kao: kardiovaskularna smrt, bilo koji događaj koronarne srčanebolesti ili ishemijskog moždanog udara bez smrtnog ishoda f Nominalna značajnost
English: EU/1/15/1031/001 1 pre-filled pen EU/1/15/1031/002 2 pre-filled pens EU/1/15/1031/003 6 pre-filled pens
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1031/001 1 napunjena brizgalica EU/1/15/1031/002 2 napunjene brizgalice EU/1/15/1031/003 6 napunjenih brizgalica
English: Placeb o
Croatian: U prilog placebu
English: At week 12, 82.1% of patients in the alirocumab group reached an LDL-C ˂70 mg/dL (˂1.81 mmol/L) compared to 7.2% of patients in the placebo group.
Croatian: Za detaljne rezultate vidjeti Tablicu 2. Vrijednost LDL-C od <70 mg/dl (<1,81 mmol/l) je u 12. tjednu postiglo 82,1% bolesnika liječenih alirokumabom u odnosu na 7,2% bolesnika koji su primali placebo.
English: At week 12 (before up-titration), 50.2% of patients reached an LDL-C of ˂70 mg/dL (˂1.81 mmol/L) as compared to 0.6% in the placebo group.
Croatian: Za detaljne rezultate vidjeti Tablicu 2. Vrijednost LDL-C od <70 mg/dl (<1,81 mmol/l) je u 12. tjednu (prije postupnog povećanja doze) postiglo 50,2% bolesnika liječenih alirokumabom u usporedbi sa 0,6% bolesnika koji su primali placebo.
English: OUTER CARTON - Pre-filled syringe 150 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE - Napunjena brizgalica od 150 mg
English: Non-HDL-C
Croatian: LDL-C (liječena populacija)b ne-HDL-C
English: Praluent 75 mg solution for injection in a pre-filled syringe alirocumab
Croatian: Praluent 75 mg otopina za injekciju u napunjenoj štrcaljki alirokumab
English: At week 12 (before up-titration), 76.0% of patients in the alirocumab group reached an LDL-C of ˂70 mg/dL (˂ 1.81 mmol/L) as compared to 11.3% in the placebo group.
Croatian: Za detaljne rezultate vidjeti Tablicu 2. Vrijednost LDL-C od <70 mg/dl (<1,81 mmol/l) je u 12. tjednu (prije postupnog povećanja doze) postiglo 76,0% bolesnika liječenih alirokumabom u usporedbi sa 11,3% bolesnika koji su primali placebo.
English: Posology
Croatian: OUTCOMES
English: OUTER CARTON - Pre-filled pen 150 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Praluent 150 mg
English: At week 12 (before up-titration), 57.7% of patients reached an LDL-C of ˂70 mg/dL (˂1.81 mmol/L) as compared to 0% in the ezetimibe group.
Croatian: Za detaljne rezultate vidjeti Tablicu 2. Vrijednost LDL-C od <70 mg/dl (<1,81 mmol/l) je u 12. tjednu (prije postupnog povećanja doze) postiglo 57,7% bolesnika u odnosu na 0% bolesnika koji su primali ezetimib.
English: OUTER CARTON - Pre-filled syringe 75 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE - Napunjena brizgalica od 75 mg
English: Praluent 150 mg solution for injection in pre-filled syringe
Croatian: Praluent 150 mg otopina za injekciju u napunjenoj štrcaljki alirokumab
English: At week 12 (before up-titration), 34.9% of patients reached an LDL-C of ˂70 mg/dL (˂1.81 mmol/L) as compared to 0% in the ezetimibe group.
Croatian: Za detaljne rezultate vidjeti Tablicu 2. Vrijednost LDL-C od <70 mg/dl (<1,81 mmol/l) je u 12. tjednu (prije postupnog povećanja doze) postiglo 34,9% bolesnika liječenih alirokumabom usporedbi sa 0% bolesnika koji su primali ezetimib.
English: Apo B Total-C Lp(a) TG
Croatian: LDL-C u mg/dl
English: Praluent 75 mg solution for injection in pre-filled syringe
Croatian: Praulent 75 mg otopina za injekciju u napunjenoj štrcaljki 30 mjeseci.
English: LDL-C (ITT)
Croatian: 12. tjedan LDL-C (ITT)a
English: LDL-C percent change from baseline was -31.6% (95% CI: -40.2%, -23.0%; p-value: ˂0.0001).
Croatian: U 24. tjednu srednja razlika u odnosu na ezetimib s obzirom na postotnu promjenu vrijednosti LDL-C od početne vrijednosti iznosila je -31,6% (95% CI: -40,2%, -23,0%; p-vrijednost: ˂0,0001).
English: In the cohort of patients on background statin, the mean baseline LDL-C was 112.7 mg/dL. At week 12, the mean percent change from baseline with alirocumab 300 mg Q4W in LDL-C (ITT analysis) was -55.3% compared to +1.1% for placebo.
Croatian: U 12. je tjednu srednji postotak promjene od početne vrijednosti s 300 mg alirokumaba svaka 4 tjedna za LDL-C (ITT analiza) bio -55,3% u usporedbi s +1,1% za placebo.
English: In the cohort of patients not treated with a concomitant statin, the mean baseline LDL-C was 142.1 mg/dL. At week 12, the mean percent change from baseline with alirocumab 300 mg Q4W in LDL-C (ITT analysis) was -58.4% compared to +0.3% for placebo.
Croatian: U 12. tjednu srednji postotak promjene LDL-C od početne vrijednosti uz 300 mg alirokumaba svaka 4 tjedna (ITT analiza) bio je -58,4% u usporedbi s +0,3% za placebo.
English: 75 mg/ml solution for injection
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Otopina za injekciju od 75 mg/ml
English: Praluent 150 mg
Croatian: Sadrži 150 mg lijeka Praluent
English: 1000 ml (25 mg/ml + 25 mg/ml)
Croatian: Vrećica (PVC) 1000 mL (25 mg/ml + 25 mg/ml)
English: 25 g / 25 g Solution for infusion
Croatian: 25 g / 25 g Otopina za infuziju Intravenski
English: Limited information is available in this population.
Croatian: Dostupne su ograničene informacije u ovoj populaciji.
English: REZOLSTA cannot work properly without food.
Croatian: REZOLSTA ne može pravilno djelovati bez hrane.
English: - Swallow the tablet whole with a drink such as water or milk.
Croatian: - Progutajte cijelu tabletu s pićem poput vode ili mlijeka.
English: HIV PI darunavir amprenavir atazanavir indinavir lopinavir saquinavir tipranavir
Croatian: HIV PI darunavir amprenavir atazanavir indinavir lopinavir sakvinavir tipranavir
English: What is REZOLSTA?
Croatian: Što je REZOLSTA?
English: You must take REZOLSTA every day and always with food.
Croatian: Lijek REZOLSTA morate uzimati svaki dan i uvijek s hranom.
English: These interactions are described in the interaction table below.
Croatian: Ove interakcije su opisane u tablici interakcija ispod.
English: REZOLSTA might reduce its effectiveness.
Croatian: REZOLSTA im može smanjiti učinkovitost.
English: Even when you feel better, do not stop taking REZOLSTA.
Croatian: Čak i ako se osjećate bolje, nemojte prestati uzimati lijek REZOLSTA.
English: 2 years 6 weeks after opening the bottle.
Croatian: 2 godine 6 tjedana nakon otvaranja boce.
English: 30 tablets in a plastic bottle.
Croatian: 30 tableta u plastičnoj boci.
English: - if you have severe liver problems.
Croatian: - ako imate teške jetrene tegobe.
English: There are other uses for sildenafil.
Croatian: Postoje i druge primjene za sildenafil.
English: What REZOLSTA is and what it is used for
Croatian: Što je REZOLSTA i za što se koristi
English: Please see section ‘Other medicines and REZOLSTA'.
Croatian: Pogledajte dio „Drugi lijekovi i REZOLSTA“.
English: REZOLSTA should be discontinued immediately if signs or symptoms of severe skin reactions develop.
Croatian: REZOLSTA se mora odmah prestati uzimati ako se razviju znakovi ili simptomi teških kožnih reakcija.
English: REZOLSTA must be taken in combination with other HIV medicines.
Croatian: REZOLSTA se mora uzimati u kombinaciji s drugim lijekovima za HIV.
English: These are mentioned above under the heading ‘Do not combine REZOLSTA with any of the following medicines:'
Croatian: Navedeni su gore pod naslovom „Nemojte kombinirati lijek REZOLSTA ni s jednim od sljedećih lijekova:“
English: Polyvinyl alcohol- partially hydrolysed Macrogol 3350
Croatian: Poli(vinilni alkohol) - djelomično hidroliziran Makrogol 3350
English: Date of first authorisation: 19 November 2014 Date of latest renewal: 31 July 2019
Croatian: Datum posljednje obnove odobrenja: 31. srpnja 2019.
English: People taking REZOLSTA may still develop infections or other illnesses associated with HIV infection.
Croatian: Osobe koje uzimaju lijek REZOLSTA i dalje mogu razvijati infekcije ili druge bolesti povezane s HIV infekcijom.
English: There are some medicines that you must not combine with REZOLSTA.
Croatian: Postoje neki lijekovi koje ne smijete kombinirati s lijekom REZOLSTA.
English: Efficacy analysis is based on 48 weeks of treatment (see table below).
Croatian: Analiza djelotvornosti temeljila se na liječenju od 48 tjedana (vidjeti tablicu ispod).
English: REZOLSTA is not for use in children and adolescents, as it has not been studied in patients under 18 years.
Croatian: REZOLSTA nije namijenjena za primjenu kod djece i adolescenata, jer nije ispitana u bolesnika mlađih od 18 godina.
English: Based on theoretical considerations, no mechanistic interaction is expected.
Croatian: Temeljeno na teorijskim postavkama, ne očekuje se mehanistička interakcija.
English: If the combination is needed, the recommended dose of rifabutin is 150 mg 3 times per week on set days (for example Monday-Wednesday-Friday).
Croatian: Ako je kombinacija potrebna, preporučena doza rifabutina je 150 mg 3 puta tjedno u određene dane (na primjer ponedjeljak-srijeda-petak).
English: Your doctor may evaluate how severe your liver disease is before deciding if you can take REZOLSTA.
Croatian: Liječnik može procijeniti koliko je teška Vaša bolest jetre prije nego što odluči možete li uzimati lijek REZOLSTA.
English: It is, therefore, important to talk to your doctor if you develop a rash.
Croatian: Stoga je važno razgovarati s liječnikom ako se pojavi osip.
English: If you forget to take REZOLSTA
Croatian: Ako ste zaboravili uzeti lijek REZOLSTA
English: When co-administration is required, the daily dose of itraconazole should not exceed 200 mg.
Croatian: Kada se zahtijeva istodobna primjena, dnevna doza itrakonazola ne smije prelaziti 200 mg.
English: Therefore, always tell your doctor if you take other anti-HIV medicines and follow your doctor's instruction carefully on which medicines can be combined.
Croatian: Stoga uvijek obavijestite liječnika ako uzimate druge lijekove protiv HIV-a i pažljivo slijedite upute liječnika o tome koji se lijekovi mogu kombinirati.
English: What REZOLSTA is and what it is used for What you need to know before you take REZOLSTA How to take REZOLSTA
Croatian: Što je REZOLSTA i za što se koristi Što morate znati prije nego počnete uzimati lijek REZOLSTA
English: Do not combine REZOLSTA with any of the following medicines If you are taking any of these, ask your doctor about switching to another medicine.
Croatian: Nemojte kombinirati lijek REZOLSTA ni s jednim od sljedećih lijekova Ako uzimate neki od navedenih lijekova, pitajte svog liječnika o prebacivanju na drugi lijek.
English: It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Croatian: Vjeruje se da ti simptomi nastaju zbog poboljšanja imunološkog odgovora organizma koji omogućava da se tijelo bori s infekcijama koje su mogle biti prisutne bez vidljivih simptoma.
English: These are: - muscle pain, tenderness or weakness.
Croatian: To su: - bol u mišićima, osjetljivost ili slabost.
English: Postpartum (6-12 weeks) N=6
Croatian: Postpartalno razdoblje (6-12 tjedana) (n=6)
English: It should be kept in mind that the twice weekly dosage of 150 mg may not provide an optimal exposure to rifabutin thus leading to a risk of rifamycin resistance and a treatment failure.
Croatian: Mora se imati na umu da doza od 150 mg dva puta tjedno možda neće omogućiti optimalnu izloženost rifabutinu, te stoga može dovesti do rizika rezistencije na rifamicin i neuspjeha liječenja.
English: It is recommended that the lowest possible dose of digoxin should initially be given to patients on REZOLSTA.
Croatian: Preporučuje se inicijalno propisati najnižu moguću dozu digoksina bolesnicima na lijeku REZOLSTA.
English: REZOLSTA is indicated, in combination with other antiretroviral medicinal products, for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years or older.
Croatian: REZOLSTA je indicirana, u kombinaciji s drugim antiretrovirusnim lijekovima, za liječenje infekcije virusom humane imunodeficijencije (HIV-1) u odraslih u dobi od 18 godina ili starijih.
English: These results were sustained up to 192 weeks of treatment in the ARTEMIS trial.
Croatian: Ti su rezultati održani do 192 tjedna liječenja u ispitivanju ARTEMIS.
English: The terminal elimination half-life of darunavir was approximately 15 hours when combined with ritonavir.
Croatian: Terminalno poluvrijeme eliminacije darunavira bilo je približno 15 sati kad se kombinirao s ritonavirom.
English: Infrequently a rash may become severe or potentially life-threatening.
Croatian: Manje često ovaj osip može postati težak i potencijalno opasan po život.