FrancophonIA/ELRC3.0 huggingface dataset:
English: Dovato can also affect how some other medicines work.
Croatian: I Dovato može utjecati na način djelovanja nekih drugih lijekova.
English: Precautions to prevent transmission should be taken in accordance with national guidelines.
Croatian: Potrebno je poduzeti mjere opreza za sprječavanje prijenosa bolesti u skladu s nacionalnim smjernicama.
English: Individual components have been investigated in adolescents (12 to 17 years).
Croatian: Pojedinačne su se sastavnice lijeka ispitivale u adolescenata (u dobi od 12 do 17 godina).
English: If you have taken Dovato during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Croatian: Ako ste uzimali Dovato tijekom trudnoće, liječnik će možda zatražiti redovito provođenje krvnih pretraga i drugih dijagnostičkih testova radi praćenja razvoja Vašeg djeteta.
English: If you take more Dovato than you should
Croatian: Ako uzmete više lijeka Dovato nego što ste trebali
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Dovato 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 Dovato u jednoj ili više podskupina pedijatrijske populacije za liječenje HIV infekcije.
English: Your doctor will review your treatment.
Croatian: Liječnik će ponovno procijeniti Vaše liječenje.
English: Interaction geometric mean change (%)
Croatian: Promjena geometrijske srednje vrijednosti (%)
English: → Don't drive or operate machinery unless you are sure you're not affected.
Croatian: Nemojte upravljati vozilima niti raditi sa strojevima ako niste potpuno sigurni da nemate te nuspojave.
English: Effects on electrocardiogram
Croatian: Učinci na elektrokardiogram
English: A small amount of the ingredients in Dovato can also pass into your breast milk.
Croatian: Mala količina sastojaka lijeka Dovato također može prijeći u majčino mlijeko.
English: Dovato should be used during pregnancy only if the expected benefit justifies the potential risk to the foetus.
Croatian: Dovato se smije uzimati tijekom trudnoće samo ako očekivana korist od liječenja opravdava mogući rizik za plod.
English: • abnormal dreams
Croatian: • neuobičajeni snovi
English: Antiviral activity in cell culture
Croatian: Antivirusna aktivnost u staničnoj kulturi
English: ViiV Healthcare BV Huis ter Heideweg 62 3705 LZ Zeist Netherlands
Croatian: ViiV Healthcare BV Huis ter Heideweg 62 3705 LZ Zeist Nizozemska
English: • depression (feelings of deep sadness and unworthiness)
Croatian: • depresija (osjećaj duboke tuge i bezvrijednosti)
English: Interaction not studied.
Croatian: Interakcija se nije ispitivala.
English: Your doctor may decide to carry out tests to check your liver, kidneys or blood, and may tell you to stop taking Dovato.
Croatian: Liječnik će možda napraviti pretrage kako bi provjerio rad jetre, bubrega ili krvi te će Vam možda reći da prestanete uzimati Dovato.
English: Symptoms usually include fever, plus some of the following:
Croatian: Simptomi obično uključuju vrućicu te neke od sljedećih simptoma:
English: Double blind therapy will continue up to week 96, followed by open label therapy up to week 148.
Croatian: Dvostruko slijepo liječenje nastavit će se do 96. tjedna, a zatim će uslijediti otvoreno liječenje do 148. tjedna.
English: → If you think this applies to you, tell your doctor.
Croatian: Ako mislite da se to odnosi na Vas, obratite se svom liječniku.
English: • The recommended dose of Dovato is one tablet once a day.
Croatian: • Preporučena doza lijeka Dovato je jedna tableta jedanput na dan.
English: The most frequently reported adverse reactions are headache (3%), diarrhoea (2%), nausea (2%) and insomnia (2%).
Croatian: Najčešće prijavljene nuspojave bile su glavobolja (3%), proljev (2%), mučnina (2%) i nesanica (2%).
English: This is an uncommon reaction (may affect up to 1 in 100 people) 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: Co-infection with Hepatitis B or C
Croatian: Istodobna infekcija virusom hepatitisa B ili C
English: This antiviral response was maintained for 3 to 4 days after the last dose in the 50 mg group.
Croatian: Taj antivirusni odgovor održao se 3 - 4 dana nakon posljednje doze u skupini koja je primala dozu od 50 mg.
English: Inhibition of OAT3 has not been studied in vivo.
Croatian: Inhibicija OAT3 nije se ispitivala in vivo.
English: → Read the information ‘Allergic reactions' in section 4 of this leaflet.
Croatian: Pročitajte informacije u odlomku ‘Alergijske reakcije' u dijelu 4. ove upute.
English: Use in adolescents
Croatian: Primjena u adolescenata
English: • aches and pains in the joints (especially in the hip, knee or shoulder)
Croatian: • tupe bolove i probadanja u zglobovima (osobito u kuku, koljenu ili ramenu)
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: 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: (≥ 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: The film-coated tablets are provided in bottles closed with child-resistant closures.
Croatian: Filmom obložene tablete dolaze u bocama zatvorenima zatvaračima sigurnima za djecu.
English: Antihistamines (histamine H2 receptor antagonists) Ranitidine
Croatian: Antihistaminici (antagonisti histaminskog H2 receptora)
English: • rifampicin, to treat tuberculosis (TB) and other bacterial infections
Croatian: • rifampicin, koji se koristi za liječenje tuberkuloze (TBC) i drugih bakterijskih infekcija
English: rash, pruritus, alopecia
Croatian: osip, pruritus, alopecija
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Croatian: U slučaju istodobne primjene antivirusne terapije za hepatitis B ili C pročitajte i relevantne informacije o lijeku za te lijekove.
English: The observed lamivudine half-life of elimination is 18 to 19 hours.
Croatian: Opaženo poluvrijeme eliminacije lamivudina iznosi 18 - 19 sati.
English: • liver failure (signs may include yellowing of the skin and the whites of the eyes or unusually dark urine)
Croatian: • zatajenje jetre (znakovi mogu uključivati žutu boju kože i bjeloočnica ili neobično tamnu mokraću)
English: The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection.
Croatian: Simptomi autoimunih poremećaja mogu se pojaviti mjesecima nakon početka uzimanja lijeka za liječenje HIV infekcije.
English: The changes are not considered to be clinically relevant and do not reflect a change in glomerular filtration rate.
Croatian: Spomenute promjene ne smatraju se klinički značajnima i ne odražavaju promjenu brzine glomerularne filtracije.
English: There are no data available on the safety of lamivudine when administered to babies less than three months old.
Croatian: Nema dostupnih podataka o sigurnosti lamivudina primijenjenog djeci mlađoj od tri mjeseca.
English: arthralgia, muscle disorders (including myalgia)
Croatian: artralgija, mišićni poremećaji (uključujući mialgiju)
English: Dovato has no or negligible influence on the ability to drive and use machines.
Croatian: Dovato ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Dovato can be taken with or without food (see section 5.2).
Croatian: Dovato se može uzimati s hranom ili bez nje (vidjeti dio 5.2).
English: If you get any of the following symptoms:
Croatian: Ako se pojavi bilo koji od sljedećih simptoma:
English: After starting treatment, the immune system becomes stronger, and may attack the infections, which can cause symptoms of infection or inflammation.
Croatian: Nakon početka liječenja imunosni sustav jača i može napasti infekcije, što može uzrokovati simptome infekcije ili upale.
English: If you could get pregnant while taking Dovato, you need to use a reliable method of barrier contraception (for example, a condom) with other methods of contraception including oral contraceptive (the pill) or other hormonal contraceptives (for example, implants or injections), to prevent pregnancy.
Croatian: Ako biste tijekom liječenja lijekom Dovato mogli zatrudnjeti, morate koristiti pouzdanu mehaničku kontracepciju (primjerice prezervativ) u kombinaciji s drugim kontracepcijskim metodama, uključujući oralne kontraceptive (pilule) ili druge hormonske kontraceptive (primjerice implantate ili injekcije) kako biste spriječili trudnoću.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Croatian: DATUM PRVOG ODOBRENJA / DATUM OBNOVE ODOBRENJA 10. DATUM REVIZIJE TEKSTA
English: A similar study was not conducted with lamivudine.
Croatian: Nije provedeno slično ispitivanje s lamivudinom.
English: Don't take other medicines for the infection without your doctor's advice.
Croatian: Nemojte uzimati druge lijekove za infekciju bez prethodnog savjetovanja sa svojim liječnikom.
English: Reduction of the metformin dose should be highly considered.
Croatian: Mora se razmotriti smanjenje doze metformina.
English: Women who are HIV-positive must not breast feed because HIV infection can be passed on to the baby in breast milk.
Croatian: Dojenje Žene koje su pozitivne na HIV ne smiju dojiti jer se HIV infekcija može majčinim mlijekom prenijeti na dijete.
English: Not everyone responds to treatment with Dovato in the same way.
Croatian: Neće sve osobe jednako odgovoriti na liječenje lijekom Dovato.
English: Dovato is a medicine that contains two active ingredients used to treat human immunodeficiency virus (HIV) infection: dolutegravir and lamivudine.
Croatian: Dovato je lijek koji sadrži dvije djelatne tvari koje se koriste za liječenje infekcije virusom humane imunodeficijencije (HIV): dolutegravir i lamivudin.
English: • difficulty moving.
Croatian: • otežano kretanje
English: • if you are allergic (hypersensitive) to dolutegravir or lamivudine or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični (preosjetljivi) na dolutegravir, lamivudin ili neki drugi sastojak ovoga lijeka (naveden u dijelu 6.)
English: → Tell your doctor or pharmacist if you are taking any of these.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate bilo koji od tih lijekova.
English: How to take Dovato
Croatian: Kako uzimati Dovato
English: Established and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in Table 1.
Croatian: Potvrđene i teorijske interakcije s odabranim antiretrovirusnim lijekovima i lijekovima koji nisu antiretrovirotici navedene su u Tablici 1.
English: Dovato contains dolutegravir.
Croatian: Dovato sadrži dolutegravir.
English: If overdose occurs, the patient should be treated supportively with appropriate monitoring, as necessary.
Croatian: Ako dođe do predoziranja, bolesnika treba liječiti potporno te po potrebi uvesti odgovarajući nadzor.
English: • This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Croatian: • Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po tableti, tj. zanemarive količine natrija.
English: Whether such neurological disorders are transient or permanent is currently unknown.
Croatian: Trenutno nije poznato jesu li ti neurološki poremećaji prolazni ili trajni.
English: Dolutegravir can cause a serious allergic reaction known as a hypersensitivity reaction.
Croatian: Dolutegravir može uzrokovati ozbiljnu alergijsku reakciju koja se naziva reakcijom preosjetljivosti.
English: There are limited data available on the use of Dovato in patients aged 65 years and over.
Croatian: Dostupni su ograničeni podaci o primjeni lijeka Dovato u bolesnika u dobi od 65 ili više godina.
English: • if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, don't stop Dovato without your doctor's advice, as your hepatitis may come back)
Croatian: • ako imate umjerenu do tešku jetrenu bolest • ako ste ikad imali jetrenu bolest, uključujući hepatitis B ili C (ako ste zaraženi virusom hepatitisa B, nemojte prestati uzimati Dovato bez prethodnog savjetovanja s liječnikom, jer se hepatitis može vratiti)
English: What Dovato looks like and contents of the pack
Croatian: Kako Dovato izgleda i sadržaj pakiranja
English: depression, anxiety, insomnia, abnormal dreams
Croatian: depresija, tjeskoba, nesanica, neuobičajeni snovi
English: Mitochondrial dysfunction
Croatian: Mitohondrijska disfunkcija
English: With this condition, parts of the bone tissue are permanently damaged because of reduced blood supply to the bone.
Croatian: Kod te su bolesti dijelovi koštanog tkiva trajno oštećeni zbog smanjenog dotoka krvi u kosti.
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: • increase in the level of liver enzymes (aminotransferases)
Croatian: • povišene vrijednosti jetrenih enzima (aminotransferaza)
English: Clinical status including liver aminotransferases and bilirubin should be monitored.
Croatian: Treba pratiti klinički status, uključujući jetrene aminotransferaze i bilirubin.
English: Relevant examples are Cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia (often referred to as PCP).
Croatian: Relevantni primjeri su citomegalovirusni retinitis, generalizirane i/ili fokalne mikobakterijske infekcije i pneumonija čiji je uzročnik Pneumocystis jirovecii (koja se često naziva PCP).
English: These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
Croatian: Ti nalazi ne utječu na trenutno važeće nacionalne preporuke za primjenu antiretrovirusne terapije u trudnica radi sprječavanja vertikalnog prijenosa HIV-a.
English: However, as the mechanism by which dolutegravir may interfere in human pregnancy is unknown, the safety in use during the second and third trimester cannot be confirmed.
Croatian: Međutim, budući da nije poznat mehanizam kojim dolutegravir može utjecati na trudnoću u ljudi, ne može se potvrditi sigurnost njegove primjene tijekom drugog i trećeg tromjesečja trudnoće.
English: • lactic acidosis (excess lactic acid in the blood)
Croatian: • laktacidoza (prekomjerna količina mliječne kiseline u krvi)
English: Then continue your treatment as before.
Croatian: Zatim nastavite liječenje prema uobičajenom rasporedu.
English: The effect of prolonged daily treatment with high doses of dolutegravir has been evaluated in repeat oral dose toxicity studies in rats (up to 26 weeks) and in monkeys (up to 38 weeks).
Croatian: Učinak dugotrajnog svakodnevnog liječenja visokim dozama dolutegravira ocijenjen je u ispitivanjima toksičnosti ponovljenih peroralnih doza na štakorima (do 26 tjedana) i majmunima (do 38 tjedana).
English: The concentration of active substance necessary to effect viral replication by 50% (IC50 - half maximal inhibitory concentration) varied according to virus and host cell type.
Croatian: Koncentracija djelatne tvari potrebna da bi se virusna replikacija smanjila za 50% (IC50 - pola maksimalne inhibicijske koncentracije) ovisila je o vrsti virusa i stanice domaćina.
English: • hyperactivity (excessive restlessness and movement)
Croatian: • hiperaktivnost (prekomjeran nemir i kretanje)
English: (See ‘Liver disease' earlier in this section and also see section 4.8).
Croatian: ‘Bolest jetre' naveden ranije u ovom dijelu kao i dio 4.8).
English: Taking Dovato at the time of becoming pregnant or during the first twelve weeks of pregnancy, may increase the risk of a birth defect, called neural tube defect, such as spina bifida (malformed spinal cord).
Croatian: Uzimanje lijeka Dovato u vrijeme začeća ili tijekom prvih dvanaest tjedana trudnoće može povećati rizik od urođene mane koja se zove oštećenje neuralne cijevi, kao što je spina bifida (malformacija kralježnične moždine).
English: (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, area under the concentration versus time curve as “AUC”, maximum observed concentration as “Cmax”).
Croatian: Tablici 1 (povećanje je označeno kao „↑”, smanjenje kao „↓”, stanje bez promjene kao „↔”, područje ispod krivulje koncentracija-vrijeme kao „AUC”, a maksimalna zabilježena koncentracija kao „Cmax”).
English: creatine phosphokinase (CPK) elevations alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) elevations
Croatian: povišene vrijednosti kreatin fosfokinaze (CPK) povišene vrijednosti alanin aminotransferaze (ALT) i/ili aspartat aminotransferaze (AST)
English: Fosamprenavir/ritonavir decreases dolutegravir concentrations, but based on limited data, did not result in decreased efficacy in Phase III studies.
Croatian: Kombinacija fosamprenavir/ritonavir smanjuje koncentracije dolutegravira, no sudeći prema ograničenim podacima to nije dovelo do smanjenja djelotvornosti u ispitivanjima faze III.
English: Anti-infective products Trimethoprim/sulfamethoxazole (Co-trimoxazole)/Lamivudine (160 mg/800 mg once daily for 5 days/300 mg single dose)
Croatian: Antiinfektivni lijekovi trimetoprim / sulfametoksazol (kotrimoksazol) / lamivudin (160 mg/800 mg jedanput na dan tijekom 5 dana / 300 mg jednokratno)
English: Some clinical findings also support a possible interaction between lamivudine and cladribine.
Croatian: Neki klinički nalazi također ukazuju na moguću interakciju između lamivudina i kladribina.
English: • a high temperature (fever)
Croatian: • visoka tjelesna temperatura (vrućica)
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia), and metabolic disorders (hyperlactatemia, hyperlipasemia).
Croatian: Glavne prijavljene nuspojave bile su hematološki poremećaji (anemija, neutropenija) i metabolički poremećaji (hiperlaktatemija, hiperlipazemija).
English: Based on more than 200 mother/child pairs treated for HIV, serum concentrations of lamivudine in breastfed infants of mothers treated for HIV are very low (< 4% of maternal serum concentrations) and progressively decrease to undetectable levels when breastfed infants reach 24 weeks of age.
Croatian: Na temelju podataka o više od 200 parova majka-dijete liječenih zbog HIV infekcije, serumske koncentracije lamivudina u dojenčadi čije su majke liječene zbog HIV infekcije vrlo su niske (< 4% serumskih koncentracija u majke) i progresivno se smanjuju do nemjerljivih razina nakon što dojenče navrši 24 tjedna.
English: Fifty-three percent of total oral dose is excreted unchanged in the faeces.
Croatian: Pedeset i tri posto ukupne peroralne doze izlučuje se u nepromijenjenu obliku kroz feces.
English: Adolescents aged between 12 and 17 years and weighing at least 40 kg can take the adult dose of one tablet once a day.
Croatian: Adolescenti u dobi od 12 do 17 godina koji teže najmanje 40 kg mogu uzimati dozu namijenjenu odraslim osobama - jednu tabletu jedanput na dan.
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Croatian: Svaki upalni simptom potrebno je procijeniti i po potrebi započeti liječenje.
English: The safety and efficacy of Dovato in children aged less than 12 years or weighing less than 40 kg have not been established.
Croatian: Sigurnost i djelotvornost lijeka Dovato u djece u mlađe od 12 godina ili tjelesne težine manje od 40 kg nisu još ustanovljene.
English: → Read the information ‘Other possible side effects' in section 4 of this leaflet.
Croatian: → Pročitajte informacije u odlomku ‘Druge moguće nuspojave', koji se nalazi u dijelu 4.
English: People may be more likely to get this condition:
Croatian: Osobe mogu biti sklonije toj bolesti:
English: • medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly
Croatian: • lijekove (obično u tekućem obliku) koji sadrže sorbitol i druge šećerne alkohole (kao što su ksilitol, manitol, laktitol ili maltitol), ako ih uzimate redovito
English: Lipid disorders should be managed as clinically appropriate.
Croatian: Poremećaje vrijednosti lipida treba liječiti na klinički odgovarajući način.
English: People with advanced HIV infection or AIDS have weak immune systems, and are more likely to develop serious infections (opportunistic infections).
Croatian: Osobe s uznapredovalom HIV infekcijom ili AIDS-om imaju oslabljen imunosni sustav te su sklonije razvoju ozbiljnih infekcija (oportunističke infekcije).
English: Lamivudine was not significantly metabolised by CYP enzymes.
Croatian: Lamivudin se nije u značajnoj mjeri metabolizirao posredstvom CYP enzima.
English: Reference should be made to treatment guidelines.
Croatian: Treba slijediti smjernice za liječenje.
English: You need to know about important signs and symptoms to look out for while you're taking Dovato.
Croatian: Morate znati na koje važne znakove i simptome treba pripaziti tijekom liječenja lijekom Dovato.
English: Dovato can be taken with or without food.
Croatian: Dovato se može uzimati s hranom ili bez nje.
English: These changes are linked to the inhibiting effect of dolutegravir on renal tubular transporters of creatinine.
Croatian: Te su promjene povezane s inhibicijskim učinkom dolutegravira na prijenosnike kreatinina u bubrežnim tubulima.
English: hypersensitivity (see section 4.4), immune reconstitution syndrome (see section 4.4)
Croatian: preosjetljivost (vidjeti dio 4.4), sindrom imunološke rekonstitucije (vidjeti dio 4.4)
English: Nucleoside and nucleotide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Croatian: Nukleozidni i nukleotidni analozi mogu u različitoj mjeri utjecati na mitohondrijsku funkciju, a taj je utjecaj najizraženiji kod primjene stavudina, didanozina i zidovudina.
English: A large amount of data on the use of lamivudine in pregnant women (more than 3000 outcomes from first trimester) indicates no malformative toxicity.
Croatian: Velika količina podataka o primjeni lamivudina u trudnica (više od 3000 ishoda trudnoća nakon izloženosti trudnica u prvom tromjesečju) ne ukazuje na malformacijsku toksičnost.
English: Trimethoprim (an inhibitor of these transporters) has been shown to increase lamivudine plasma concentrations, however the resulting increase was not clinically significant (see Table 1).
Croatian: Pokazalo se da trimetoprim (inhibitor tih prijenosnika) povećava plazmatske koncentracije lamivudina, no to povećanje nije bilo klinički značajno (vidjeti Tablicu 1).
English: Oral contraceptives Ethinyl estradiol (EE) and Norgestromin (NGMN)/Dolutegravir
Croatian: Oralni kontraceptivi etinilestradiol (EE) i norelgestromin (NGMN) / dolutegravir
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Croatian: Pojave li se u tih bolesnika znakovi pogoršanja jetrene bolesti, mora se razmotriti privremeni ili trajni prekid liječenja.
English: This increase is not considered clinically relevant.
Croatian: To se povećanje ne smatra klinički značajnim.
English: • emtricitabine, etravirine, efavirenz, nevirapine or tipranavir/ritonavir, to treat HIV infection
Croatian: • emtricitabin, etravirin, efavirenz, nevirapin ili tipranavir/ritonavir, koji se koriste za liječenje