FrancophonIA/ELRC3.0 huggingface dataset:
English: Inflammation of the salivary gland, skin and lip cancer (non-melanoma skin cancer), decreases in the number (or even lack) of cells in the blood, including low red and white blood cell count, , serious allergic reactions (e.g. hypersensitivity, anaphylactic reaction), decreased or loss of appetite, restlessness, light-headedness, blurred or yellowing of vision, decrease in vision and eye pain (possible signs of acute myopia or acute-angle closure glaucoma), inflammation of blood vessels (vasculitis necrotising), inflamed pancreas, upset stomach, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition mimicking a disease called systemic lupus erythematosus where the body's immune system attacks the body); skin disorders such as inflamed blood vessels in the skin, increased sensitivity to sunlight, rash, redness of the skin, blistering of the lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme) weakness, kidney inflammation or impaired kidney function, glucose in the urine (glycosuria), fever, impaired electrolyte balance, high blood cholesterol levels, decreased blood volume, increased blood levels of glucose, difficulties in controlling blood/ urine levels of glucose in patients with a diagnosis of diabetes mellitus, or fat in the blood.
Croatian: Upala žlijezda slinovnica, rak kože i usana (nemelanomski rak kože), smanjenje broja (ili čak nedostatak) stanica u krvi, uključujući niske vrijednosti crvenih i bijelih krvnih stanica, ozbiljne alergijske reakcije (npr. preosjetljivost, anfilaktička reakcija), smanjeni ili gubitak apetita, nemir, ošamućenost, zamućeni vid ili žutilo pred očima, smanjenje vida i bol u očima (mogući znakovi akutne miopije i akutnog glaukoma zatvorenog kuta), upala krvnih žila (nekrotizirajući vaskulitis), upala gušterače (pankreatitis), nadražen želudac, žutilo kože ili bjeloočnica (žutica), sindrom sličan lupusu (stanje koje oponaša bolest koja se naziva sistemski lupus eritematozus pri kojem imunološki sustav tijela napada tijelo), poremećaji kože kao što je upala krvnih žila kože, povećana osjetljivost na sunčevu svjetlost, osip, crvenilo kože, mjehurići na usnama, očima ili u ustima, ljuštenje kože, vrućica (mogući znakovi multiformnog eritema), slabost, upala bubrega ili oštećenje bubrežne funkcije, glukoza u urinu (glikozurija), vrućica, poremećena ravnoteža elektrolita, visoke vrijednosti kolesterola u krvi, smanjeni volumen krvi, porast razine glukoze u krvi, poteškoće u kontroliranju razine glukoze u krvi/urinu kod bolesnika s dijagnozom šećerne bolesti, ili masnoća u krvi.
English: The overall incidence and pattern of adverse reactions reported with PritorPlus 80 mg/25 mg was comparable with PritorPlus 80 mg/12.5 mg. A dose-relationship of adverse reactions was not established and they showed no correlation with gender, age or race of the patients.
Croatian: Ukupna incidencija i obrazac nuspojava prijavljenih uz MicardisPlus 80 mg/25 mg usporedivi su s MicardisPlus 80 mg/12,5 mg.
English: Tel: +46-(0)8-580 223 00
Croatian: KG Tel: +49 (0) 800 / 77 90 900
English: Magyarország Bayer Hungária Kft. Tel.:+36-14 87-41 00
Croatian: Boehringer Ingelheim RCV GmbH & Co KG Tel: +43 1 80 105-7870
English: Bayer Limited Tel: +353 1 299 93 13
Croatian: Tel: +351 21 313 53 00
English: MARKETING AUTHORISATION NUMBER(S) PritorPlus 40 mg/12.5 mg tablets EU/1/02/215/001-005, 011, 013
Croatian: EU/1/02/213/001-005, 011, 013-014
English: Байер България ЕООД Тел.
Croatian: Бьорингер Ингелхайм РЦВ ГмбХ и Ко.
English: United Kingdom Bayer plc
Croatian: United Kingdom Boehringer Ingelheim Ltd.
English: Deutschland Bayer Vital GmbH Tel: +49-(0)214-30 513 48
Croatian: Česká republika Boehringer Ingelheim spol. s r.o. Tel: +420 234 655 111
English: Tlf.
Croatian: Omaglica
English: Inhalation powder Inhalation use inhaler
Croatian: Put primjene Unutarnje pakovanje
English: R(-) methadone:
Croatian: R(-) metadon:
English: Alternatives should be considered, particularly for long-term use.
Croatian: Treba razmotriti druge mogućnosti, osobito za dugoročnu primjenu.
English: The clinical implications of this finding are currently unknown.
Croatian: Kliničke implikacije tog nalaza trenutno nisu poznate.
English: Not known Frequency cannot be estimated from the available data:
Croatian: Učestalost se ne može procijeniti iz dostupnih podataka:
English: • suicidal thoughts and behaviours (particularly in patients who have had depression or mental health problems before)
Croatian: • suicidalne misli i ponašanja (osobito u bolesnika koji su ranije imali problema s depresijom ili mentalnim zdravljem)
English: • any medicines to treat HIV infection
Croatian: • bilo koji lijek za liječenje HIV infekcije
English: →Do not take a double dose to make up for a forgotten dose.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: A protein-rich nutritional drink alone does not replace a meal.
Croatian: Napitak bogat proteinima ne zamjenjuje obrok.
English: A meal is important to get the right levels of medicine in your body.
Croatian: Uzimanje uz obrok važno je za postizanje odgovarajućih razina lijeka u tijelu.
English: N = Number of subjects in each treatment arm
Croatian: N = broj ispitanika u svakoj liječenoj skupini
English: ATC code: J05AR21
Croatian: ATK oznaka: J05AR21
English: No integrase resistance was observed.
Croatian: Nije opažena rezistencija integraze.
English: People may be more likely to get this condition:
Croatian: Osobe mogu biti sklonije tom stanju:
English: Effect of human serum and serum proteins
Croatian: Utjecaj ljudskog seruma i proteina u serumu
English: → Tell your doctor immediately.
Croatian: → Odmah se javite liječniku.
English: • Do not chew, crush or split the tablet, to ensure the full dose is taken.
Croatian: • Nemojte žvakati, drobiti niti lomiti tabletu, kako biste bili sigurni da ćete uzeti cijelu dozu.
English: If you take more Juluca than you should
Croatian: Ako uzmete više lijeka Juluca nego što ste trebali
English: Currently available data are described in section 5.2, but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelu 5.2, ali nije moguće dati preporuku o doziranju.
English: *based on historic controls.
Croatian: *na temelju kontrola iz prethodnih ispitivanja
English: This medicine is not for use in children or adolescents less than 18 years of age, because it has not been studied in these patients.
Croatian: Ovaj lijek nije namijenjen za primjenu u djece i adolescenata mlađih od 18 godina jer se u tih bolesnika nije ispitivao.
English: • allergic (hypersensitivity) reaction (see ‘allergic reactions' earlier in this section)
Croatian: • alergijska reakcija (reakcija preosjetljivosti) (pogledajte odlomak ‘Alergijske reakcije' naveden ranije u ovom dijelu)
English: Therefore, information regarding drug-drug interactions with other antiretroviral medicinal products is not provided.
Croatian: Stoga se ne navode informacije o interakcijama s drugim antiretrovirusnim lijekovima.
English: • depressed mood
Croatian: • depresivno raspoloženje
English: What Juluca is and what it is used for
Croatian: Što je Juluca i za što se koristi
English: Film-coated tablet (tablet).
Croatian: OBLIK Filmom obložena tableta (tableta).
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Učestalost je definirana kao vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, area under the concentration versus time curve as “AUC”, maximum observed concentration as “Cmax”, concentration at end of dosing interval as “Cτ”).
Croatian: (povećanje je označeno kao ‘↑', smanjenje kao ‘↓', stanje bez promjene kao ‘↔', površina ispod krivulje koncentracija-vrijeme kao ‘AUC', maksimalna zabilježena koncentracija kao ‘Cmax', a koncentracija na kraju intervala doziranja kao ‘Cτ').
English: What Juluca looks like and contents of the pack
Croatian: Kako Juluca izgleda i sadržaj pakiranja
English: • increase in cholesterol
Croatian: • povišene vrijednosti kolesterola
English: As a number of different medicines can cause this condition, you should ask your doctor or pharmacist if you are not sure
Croatian: Budući da postoji nekoliko različitih lijekova koji mogu uzrokovati to stanje, pitajte svog liječnika ili ljekarnika ako niste sigurni
English: These changes are related to inhibition of active transport, and are not considered to be clinically relevant as they do not reflect a change in glomerular filtration rate.
Croatian: Spomenute promjene povezane su s inhibicijom aktivnog prijenosa i ne smatraju se klinički značajnima jer ne odražavaju promjenu u brzini glomerularne filtracije.
English: Symptoms of infection may develop, caused by old, hidden infections flaring up again as the body fights them.
Croatian: Mogu se razviti simptomi infekcije, uzrokovani starim i prikrivenim infekcijama koje se razbuktaju kada se tijelo počne boriti protiv njih.
English: Reduction of the metformin dose should be highly considered.
Croatian: Mora se dobro razmotriti smanjenje doze metformina.
English: • rifabutin, to treat tuberculosis (TB) and other bacterial infections.
Croatian: • rifabutin, koji se koristi za liječenje tuberkuloze (TBC) i drugih bakterijskih infekcija.
English: Juluca can also affect how some other medicines work.
Croatian: I Juluca može utjecati na način djelovanja nekih drugih lijekova.
English: It is recommended that the filmcoated tablet be swallowed whole with water and not be chewed or crushed.
Croatian: Filmom obloženu tabletu preporučuje se progutati cijelu s vodom te je se ne smije žvakati niti drobiti.
English: The most common mutations were the same in the week 48 and week 96 analyses.
Croatian: Najčešće mutacije bile su jednake u analizi provedenoj u 48. tjednu i onoj provedenoj u 96. tjednu.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Juluca in one or more subsets of the paediatric population in the treatment of HIV infection.
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Juluca u jednoj ili više podskupina pedijatrijske populacije za liječenje HIV infekcije.
English: Clinical safety data with Juluca is limited.
Croatian: Klinički podaci o sigurnosti lijeka Juluca su ograničeni.
English: HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles).
Croatian: HIV infekcija širi se spolnim odnosom s nekime tko je već zaražen ili prijenosom zaražene krvi (primjerice, dijeljenjem igala za injekciju).
English: Other medicines and Juluca
Croatian: Drugi lijekovi i Juluca
English: Rilpivirine is approximately 99.7% bound to plasma proteins in vitro, primarily to albumin.
Croatian: Približno 99,7% rilpivirina veže se za proteine u plazmi in vitro, prvenstveno za albumin.
English: What you need to know before you take Juluca
Croatian: Što morate znati prije nego počnete uzimati lijek Juluca
English: Juluca keeps the amount of HIV virus in your body at a low level.
Croatian: Juluca održava količinu HIV-a u tijelu na niskoj razini.
English: • medicines that may cause a life threatening irregular heartbeat (Torsade de Pointes).
Croatian: • lijekove koji mogu izazvati po život opasne nepravilne srčane otkucaje (torsade de pointes).
English: Carcinogenicity studies with rilpivirine in mice and rats revealed tumorigenic potential specific for these species, but are regarded as of no relevance for humans.
Croatian: Ispitivanja kancerogenosti rilpivirina u miševa i štakora otkrila su tumorogeni potencijal specifičan za te vrste, ali se on ne smatra značajnim za ljude.
English: The safety and efficacy of Juluca in children and adolescents aged less than 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Juluca u djece i adolescenata mlađih od 18 godina još nisu ustanovljene.
English: The R263K mutation was also selected in vitro (see above).
Croatian: R263K također je bila izdvojena in vitro (vidjeti gore).
English: In phase 3 studies, lower rilpivirine exposure, similar to that seen during pregnancy, has been associated with an increased risk of virological failure.
Croatian: U ispitivanjima faze 3 manja izloženost rilpivirinu, slična onoj primijećenoj tijekom trudnoće, bila je povezana s povećanim rizikom od virološkog neuspjeha.
English: If you take rifabutin, your doctor may need to give you an additional dose of rilpivirine.
Croatian: Ako uzimate rifabutin, liječnik će Vam možda morati dati dodatnu dozu rilpivirina.
English: Women who are HIV-positive must not breast feed because HIV infection can be passed on to the baby in breast milk.
Croatian: Žene koje su pozitivne na HIV ne smiju dojiti jer se HIV infekcija može majčinim mlijekom prenijeti na dijete.
English: Pharmacokinetic data in subjects >65 years old are very limited.
Croatian: Farmakokinetički podaci o primjeni u ispitanika starijih od 65 godina vrlo su ograničeni.
English: Only H2-receptor antagonists that can be dosed once daily should be used.
Croatian: H2-receptora koji se mogu primjenjivati jedanput na dan.
English: Juluca should not be co-administered at the same time as H2-receptor antagonists.
Croatian: Juluca se ne smije primjenjivati istodobno s antagonistima H2-receptora.
English: NA = Not applicable
Croatian: NP = nije primjenjivo
English: * Adjusted for baseline stratification factors and assessed using a non-inferiority margin of - 8%.
Croatian: * Prilagođeno za početne faktore stratifikacije i ocijenjeno koristeći graničnu vrijednost neinferiornosti od -8%.
English: If overdose occurs, the patient should be treated supportively with appropriate monitoring, including monitoring of vital signs and ECG (QT interval), as necessary.
Croatian: Ako dođe do predoziranja, bolesnika treba liječiti suportivno te po potrebi uvesti odgovarajući nadzor, uključujući praćenje vitalnih znakova i EKG-a (QT intervala).
English: If you forget to take Juluca
Croatian: Ako ste zaboravili uzeti lijek Juluca
English: Your doctor may decide to carry out tests to check your liver, kidneys or blood, and may tell you to stop taking Juluca.
Croatian: Liječnik će možda napraviti pretrage kako bi provjerio rad jetre, bubrega ili krv te će Vam možda reći da prestanete uzimati lijek Juluca.
English: The distribution of rilpivirine into compartments other than plasma (e.g., cerebrospinal fluid, genital tract secretions) has not been evaluated in humans.
Croatian: Distribucija rilpivirina u druge odjeljke osim plazme (npr. cerebrospinalnu tekućinu, genitalne izlučevine) nije se ocjenjivala u ljudi.
English: If you have been told by your doctor that you have intolerance to some sugars, speak with your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja ovog lijeka.
English: There are limited data available on the use of Juluca in patients aged 65 years and over.
Croatian: Dostupni su ograničeni podaci o primjeni lijeka Juluca u bolesnika u dobi od 65 ili više godina.
English: All other drug-drug interactions shown are predicted.
Croatian: Sve druge prikazane interakcije između lijekova su predviđanja.
English: No mother to child transmission occurred in all 10 infants born to the mothers who completed the trial and for whom the HIV status was available.
Croatian: Prijenos infekcije s majke na dijete nije zabilježen ni u jednoga od 10 novorođenčadi majki koje su završile sudjelovanje u ispitivanju i za koje je bio dostupan HIV status.
English: There is no evidence that elderly patients require a different dose than younger adult patients (see section 5.2).
Croatian: Nema dokaza koji bi ukazivali na to da je starijim bolesnicima potrebna drugačija doza nego mlađim odraslim bolesnicima (vidjeti dio 5.2).
English: • difficulty in sleeping (insomnia).
Croatian: • tegobe sa spavanjem (nesanica)
English: Juluca is a medicine that contains two active ingredients used to treat human immunodeficiency virus (HIV) infection: dolutegravir and rilpivirine.
Croatian: Juluca je lijek koji sadrži dvije djelatne tvari koje se koriste za liječenje infekcije virusom humane imunodeficijencije (HIV): dolutegravir i rilpivirin.
English: This is an uncommon (may affect up to 1 in 100 people) reaction in people taking dolutegravir.
Croatian: To je manje česta nuspojava (može se javiti u do 1 na 100 osoba) kod osoba koje uzimaju dolutegravir.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 May 2018
Croatian: Datum prvog odobrenja: 16. svibnja 2018.
English: 4.4 Special warnings and precautions for use Transmission of HIV
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Prijenos HIV-a
English: SWORD-1 and SWORD-2 Pooled Data*** DTG + RPV N=513 n (%)
Croatian: Objedinjeni podaci iz ispitivanja SWORD-1 i SWORD-2*** DTG + RPV N=513 n (%)
English: If you are breast-feeding, or thinking about breast-feeding: → Talk to your doctor immediately.
Croatian: Ako dojite ili razmišljate o dojenju: → Odmah razgovarajte sa svojim liječnikom.
English: However, clinical monitoring is recommended as methadone maintenance therapy may need to be adjusted in some patients.
Croatian: Međutim, preporučuje se kliničko praćenje jer će u nekih bolesnika možda trebati prilagoditi terapiju održavanja metadonom.
English: In subtype C (n=2) and A/G (n=2) isolates the integrase substitution R263K was selected in one isolate, and G118R in two isolates.
Croatian: U izolatima podtipa C (n=2) i A/G (n=2), supstitucija R263K na integrazi izdvojena je u jednom izolatu, a supstitucija G118R u dvama izolatima.
English: Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci iza oznake ‘EXP'.
English: The pharmacokinetic data demonstrate that total exposure (AUC) to rilpivirine as a part of an antiretroviral regimen was approximately 30% lower during pregnancy compared with postpartum (6-12 weeks).
Croatian: Farmakokinetički podaci pokazuju da je ukupna izloženost (AUC) rilpivirinu kao dijelu antiretrovirusnog režima bila približno 30% manja tijekom trudnoće nego nakon poroda (6 - 12 tjedana).
English: → Tell your doctor.
Croatian: Obavijestite svog liječnika.
English: There is limited information available on the potential for a pharmacodynamic interaction between rilpivirine and medicinal products that prolong the QTc interval of the ECG.
Croatian: Dostupne su ograničene informacije o mogućnosti farmakodinamičke interakcije između rilpivirina i lijekova koji produljuju QTc interval na EKG-u.
English: In these cases the physician should refer to the Summary of Product Characteristics for these medicinal products.
Croatian: U tim slučajevima liječnik mora pročitati sažetak opisa svojstava lijeka za te lijekove.
English: (Not studied)
Croatian: (Interakcija se nije ispitivala)
English: Increases in serum creatinine occurred within the first four weeks of treatment with Juluca and remained stable through 48 weeks.
Croatian: Povećanja koncentracije kreatinina u serumu nastupila su unutar prva četiri tjedna liječenja lijekom Juluca, nakon čega su vrijednosti bile stabilne do 48. tjedna.
English: Your doctor may decide that you need extra check ups.
Croatian: Liječnik će možda odlučiti dogovoriti dodatne kontrolne preglede.
English: The E138K substitution emerged most frequently during rilpivirine treatment, commonly in combination with the M184I substitution.
Croatian: Tijekom liječenja rilpivirinom najčešće se javljala supstitucija E138K, često u kombinaciji sa supstitucijom M184I.
English: With this condition, parts of the bone tissue die because of reduced blood supply to the bone.
Croatian: Kod tog stanja dijelovi koštanog tkiva odumiru zbog smanjenog dotoka krvi u kosti.
English: • clarithromycin and erythromycin, to treat bacterial infections
Croatian: • klaritromicin i eritromicin, koji se koriste za liječenje bakterijskih infekcija
English: While 24 infants were confirmed to be uninfected, 5 were indeterminate due to incomplete testing, see sections 4.2, 4.4 and 5.2.
Croatian: Dok je u 24 novorođenčadi potvrđen izostanak infekcije, kod njih 5 se to nije moglo sa sigurnošću utvrditi zbog nepotpunog testiranja (vidjeti dijelove 4.2, 4.4 i 5.2).
English: Changes in laboratory biochemistries
Croatian: Promjene u laboratorijskim nalazima biokemijskih parametara
English: Immune system disorders uncommon hypersensitivity (see section 4.4) not known immune reconstitution syndrome
Croatian: Poremećaji imunološkog sustava manje često preosjetljivost (vidjeti dio 4.4) nepoznato sindrom imunološke rekonstitucije
English: Some people taking combination therapy for HIV develop a condition called osteonecrosis.
Croatian: U nekih osoba koje uzimaju kombiniranu terapiju za HIV infekciju može se razviti stanje koje se zove osteonekroza.
English: If you notice any of these symptoms:
Croatian: Ako primijetite bilo koji od navedenih simptoma:
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Croatian: Svaki upalni simptom potrebno je ocijeniti i po potrebi započeti liječenje.
English: Rilpivirine in combination with a background regimen was evaluated in a clinical trial of 19 pregnant women during the second and third trimesters, and postpartum.
Croatian: Rilpivirin se u kombinaciji s osnovnim režimom ocjenjivao u kliničkom ispitivanju provedenom u 19 trudnica, i to tijekom drugog i trećeg tromjesečja i nakon poroda.
English: Previously untreated HIV-1 infected adult patients
Croatian: Prethodno neliječeni odrasli bolesnici s HIV-1 infekcijom
English: Of the 12 subjects that completed the study, 10 subjects were suppressed at the end of the study; in the other 2 subjects an increase in viral load was observed postpartum, for 1 subject due to suspected suboptimal adherence.
Croatian: Od 12 ispitanica koje su završile ispitivanje, njih 10 imalo je virološku supresiju na kraju ispitivanja; u ostale 2 ispitanice povećanje virusnog opterećenja primijećeno je nakon poroda, a sumnja se da je kod jedne od njih bilo uzrokovano suboptimalnim pridržavanjem liječenja.
English: Dolutegravir and rilpivirine have been associated with increases in serum creatinine occuring in the first week of treatment when administered with other antiretroviral medicinal products.
Croatian: Dolutegravir i rilpivirin povezuju se s povećanjima koncentracije kreatinina u serumu u prvom tjednu liječenja kada se primjenjuju istodobno s drugim antiretrovirusnim lijekovima.
English: If possible, show them the Juluca pack.
Croatian: pokažite im pakiranje lijeka Juluca.
English: Potential increase via inhibition of OCT2 transporter.
Croatian: Moguće je povećanje koncentracije zbog inhibicije prijenosnika OCT2.
English: In the trials, the presence of the mutations V90I and V189I, at baseline, did not affect response.
Croatian: U tim ispitivanjima prisutnost mutacija V90I i V189I na početku liječenja nije utjecala na odgovor.
English: Juluca may replace your current antiretroviral medicines.
Croatian: Juluca može zamijeniti antiretrovirusne lijekove koje trenutno uzimate.
English: This combination may increase the risk for lactic acidosis in patients with moderate renal impairment (stage 3a creatinine clearance [CrCl] 45- 59 mL/min) and a cautious approach is recommended.
Croatian: Ta kombinacija može povećati rizik od pojave laktacidoze u bolesnika s umjerenim oštećenjem bubrežne funkcije (stupanj 3a, klirens kreatinina [CrCl] 45 - 59 ml/min) te se preporučuje oprezan pristup.