FrancophonIA/ELRC3.0 huggingface dataset:
English: Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56% (Complex binding to polyvalent ions)
Croatian: dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56% (stvaranje kompleksa s polivalentnim ionima)
English: Antacid medicines
Croatian: Antiretrovirusni lijekovi
English: Dolutegravir ↓ AUC ↓ 39% Cmax ↓ 37% C24 ↓ 39% (Complex binding to polyvalent ions)
Croatian: dolutegravir ↓ AUC ↓ 39% Cmax ↓ 37% C24 ↓ 39% (stvaranje kompleksa s polivalentnim ionima)
English: Population PK analyses using pooled pharmacokinetic data from clinical studies where dolutegravir was administered to adults in combination with other ARVs revealed no clinically relevant effect of race on the exposure of dolutegravir.
Croatian: Populacijske farmakokinetičke analize objedinjenih farmakokinetičkih podataka iz kliničkih ispitivanja u kojima se dolutegravir primjenjivao u kombinaciji s drugim antiretrovirusnim lijekovima u odraslih osoba pokazale su da rasa nije imala klinički značajnog učinka na izloženost dolutegraviru.
English: Uncommon side effects that may show up in blood tests are:
Croatian: Manje česte nuspojave koje se mogu vidjeti u nalazima krvnih pretraga:
English: General disorders and administration site conditions: Common:
Croatian: Opći poremećaji i reakcije na mjestu primjene: Često:
English: Dolutegravir ↔ AUC ↑ 11% Cmax ↑ 6% Cτ ↑ 17%
Croatian: Kortikosteroidi prednizon / dolutegravir dolutegravir ↔ AUC ↑ 11% Cmax ↑ 6% Cτ ↑ 17%
English: Dovato 50 mg/300 mg film-coated tablets dolutegravir/lamivudine
Croatian: Dovato 50 mg/300 mg tablete dolutegravir/lamivudin
English: Dolutegravir ↓ AUC ↓ 33% Cmax ↓ 35% C24 ↓ 32% (Complex binding to polyvalent ions)
Croatian: dolutegravir ↓ AUC ↓ 33% Cmax ↓ 35% C24 ↓ 32% (stvaranje kompleksa s polivalentnim ionima)
English: Drug interactions
Croatian: Interakcija
English: Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and 300 mg lamivudine.
Croatian: Jedna filmom obložena tableta sadrži 50 mg dolutegravira u obliku dolutegravirnatrija i 300 mg lamivudina.
English: Tel: + 34 902 051 260 es-ci@viivhealthcare.com
Croatian: Laboratorios ViiV Healthcare, S.L. Tel: + 34 902 051 260 es-ci@viivhealthcare.com
English: Each tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and 300 mg lamivudine.
Croatian: Jedna tableta sadrži 50 mg dolutegravira u obliku dolutegravirnatrija i 300 mg lamivudina.
English: How to store Dovato
Croatian: Moguće nuspojave Kako čuvati Dovato
English: If you take Dovato with food, you can take supplements or multivitamins containing calcium, iron or magnesium at the same time as Dovato.
Croatian: Ako Dovato uzimate s hranom, možete istodobno uzeti i dodatke prehrani ili multivitaminske pripravke koji sadrže kalcij, željezo ili magnezij.
English: The clinical status of the patient and the adverse reaction profile of Dovato should be borne in mind when considering the patient's ability to drive or operate machinery.
Croatian: Kada se razmatra bolesnikova sposobnost upravljanja vozilima ili rada sa strojevima, u obzir treba uzeti kliničko stanje bolesnika i profil nuspojava lijeka Dovato.
English: The primary efficacy endpoint for each GEMINI trial was the proportion of subjects with plasma HIV-1 RNA <50 copies/mL at Week 48 (Snapshot algorithm for the ITT-E population).
Croatian: Primarna mjera ishoda za djelotvornost u ispitivanjima GEMINI bio je udio ispitanika kojima je plazmatska koncentracija HIV-1 RNK u 48. tjednu iznosila < 50 kopija/ml (algoritam za globalnu snimku distribuiranog sustava [engl. snapshot algorithm] za populaciju bolesnika predviđenih za liječenje koji su primili najmanje jednu dozu ispitivanog lijeka [engl. intent-to-treat exposed, ITT-E]).
English: 1 This adverse reaction was identified through post-marketing surveillance for dolutegravir in combination with other ARVs.
Croatian: Ova je nuspojava utvrđena tijekom praćenja sigurnosti dolutegravira u kombinaciji s drugim antiretroviroticima nakon stavljanja u promet.
English: • stomach (abdominal) pain or discomfort
Croatian: • bol ili nelagoda u trbuhu (abdomenu)
English: Lamivudine exhibits linear pharmacokinetics over the therapeutic dose range and displays limited plasma protein binding in vitro (< 16%- 36% to serum albumin).
Croatian: Lamivudin pokazuje linearnu farmakokinetiku u rasponu terapijskih doza te se u ograničenoj mjeri veže za proteine u plazmi in vitro
English: • stiffness in the joints
Croatian: • bol u zglobovima
English: • breakdown of muscle tissue.
Croatian: • upala gušterače (pankreatitis) • razgradnja mišićnog tkiva
English: NAME OF THE MEDICINAL PRODUCT Dovato 50 mg/300 mg film-coated tablets
Croatian: Dovato 50 mg/300 mg filmom obložene tablete
English: Dolutegravir was shown to cross the placenta in animals.
Croatian: Pokazalo se da dolutegravir prolazi kroz posteljicu u životinja.
English: No dose adjustment is required in patients with mild renal impairment.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim oštećenjem bubrežne funkcije.
English: Proton pump inhibitors Omeprazole
Croatian: Dolutegravir je inhibitor
English: Dolutegravir ↔ AUC ↓ 4% Cmax ↔ 0% C24 ↓ 6%
Croatian: lopinavir + ritonavir / dolutegravir dolutegravir ↔ AUC ↓ 4% Cmax ↔ 0% C24 ↓ 6%
English: peripheral neuropathy, paraesthesia Gastrointestinal disorders:
Croatian: periferna neuropatija, parestezija
English: Dolutegravir ↔ AUC ↑ 11% Cmax ↑ 7% Cτ ↑ 28%
Croatian: lopinavir + ritonavir + etravirin / dolutegravir dolutegravir ↔ AUC ↑ 11% Cmax ↑ 7% Cτ ↑ 28%
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
English: Musculoskeletal and connective tissue disorders: Common:
Croatian: angioedem Poremećaji mišićno-koštanog sustava i vezivnog tkiva:
English: Discontinued for lack of efficacy
Croatian: Prekid sudjelovanja u ispitivanju zbog drugih razloga
English: Common:
Croatian: Pretrage:
English: Lopinavir ↔ Ritonavir ↔ Etravirine ↔
Croatian: lopinavir ↔ ritonavir ↔ etravirin ↔
English: The apparent oral clearance (CL/F) is approximately 1 L/hr in HIV-infected patients based on a population pharmacokinetic analysis.
Croatian: Na temelju populacijske farmakokinetičke analize utvrđeno je da prividni klirens nakon peroralne primjene (CL/F) u bolesnika s HIV infekcijom iznosi približno 1 l/h.
English: Joint pain, stiffness and bone problems
Croatian: Bol i ukočenost u zglobovima, tegobe s kostima
English: Dolutegravir ↓ AUC ↓ 57% Cmax ↓ 39% Cτ ↓ 75%
Croatian: efavirenz / dolutegravir dolutegravir ↓ AUC ↓ 57% Cmax ↓ 39% Cτ ↓ 75%
English: Atazanavir ↔ (historical controls) (inhibition of UGT1A1 and CYP3A enzymes)
Croatian: atazanavir ↔ (kontrole iz prethodnih ispitivanja) (inhibicija enzima UGT1A1 i CYP3A)
English: When administered in fasted state, bioequivalence was achieved for lamivudine AUC, when comparing Dovato to lamivudine 300 mg co-administered with dolutegravir 50 mg. Lamivudine Cmax for Dovato was 32% higher than lamivudine 300 mg co-administered with dolutegravir 50 mg.
Croatian: Kod primjene natašte postignuta je bioekvivalentnost s obzirom na AUC lamivudina između lijeka Dovato i lamivudina u dozi od 300 mg primijenjenog istodobno s dolutegravirom u dozi od 50 mg.
English: Very rare side effects that may show up in blood tests are: • a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
Croatian: • nemogućnost koštane srži da proizvede nove crvene krvne stanice (izolirana aplazija crvenih krvnih stanica)
English: Oral administration of dolutegravir to pregnant rats at doses up to 1000 mg/kg daily from days 6 to 17 of gestation did not elicit maternal toxicity, developmental toxicity or teratogenicity (37.2 times the 50 mg human clinical exposure, based on AUC following single dose in the fasted state).
Croatian: 6. do 17. dana gestacije nije uzrokovala toksičnost za majku, razvojnu toksičnost ni teratogenost (izloženost 37,2 puta veća od kliničke izloženosti u ljudi kod primjene doze od 50 mg, što je utvrđeno na temelju AUC-a nakon primjene jednokratne doze natašte).
English: Effect of dolutegravir: EE ↔ AUC ↑ 3% Cmax ↓ 1%
Croatian: EE ↔ AUC ↑ 3% Cmax ↓ 1%
English: Dolutegravir↓ AUC ↓ 35% Cmax ↓ 24% Cτ ↓ 49%
Croatian: fosamprenavir + ritonavir / dolutegravir dolutegravir ↓ AUC ↓ 35% Cmax ↓ 24% Cτ ↓ 49%
English: Dolutegravir ↓ AUC ↓ 22% Cmax ↓ 11% Cτ ↓ 38%
Croatian: darunavir + ritonavir / dolutegravir dolutegravir ↓ AUC ↓ 22% Cmax ↓ 11% Cτ ↓ 38%
English: PHARMACEUTICAL FORM AND CONTENTS 30 tablets
Croatian: 30 tableta
English: Lamivudine is cleared renally.
Croatian: Lamivudin se izlučuje putem bubrega.
English: An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy.
Croatian: Tijekom antiretrovirusne terapije može doći do povećanja tjelesne težine te povišenja razine lipida i glukoze u krvi.
English: Darunavir ↔ Ritonavir ↔ Etravirine ↔
Croatian: darunavir ↔ ritonavir ↔ etravirin ↔
English: NAME OF THE MEDICINAL PRODUCT Dovato 50 mg/300 mg film-coated tablets dolutegravir/lamivudine
Croatian: Dovato 50 mg/300 mg filmom obložene tablete dolutegravir/lamivudin
English: Etravirine ↔ (induction of UGT1A1 and CYP3A enzymes)
Croatian: etravirin ↔ (indukcija enzima UGT1A1 i CYP3A)
English: Dolutegravir ↓ AUC ↓ 25% Cmax ↓ 12% Cτ ↓ 36%
Croatian: darunavir + ritonavir + etravirin / dolutegravir dolutegravir ↓ AUC ↓ 25% Cmax ↓ 12% Cτ ↓ 36%
English: Efavirenz ↔ (historical controls) (induction of UGT1A1 and CYP3A enzymes)
Croatian: efavirenz ↔ (kontrole iz prethodnih ispitivanja) (indukcija enzima UGT1A1 i CYP3A)
English: Vistor hf.
Croatian: Prijenos HIV-a
English: Dolutegravir ↓ AUC ↓ 59% Cmax ↓ 47% Cτ ↓ 76%
Croatian: tipranavir + ritonavir / dolutegravir dolutegravir ↓ AUC ↓ 59% Cmax ↓ 47% Cτ ↓ 76%
English: Tipranavir ↔ Ritonavir ↔ (induction of UGT1A1 and CYP3A enzymes)
Croatian: tipranavir ↔ ritonavir ↔ (indukcija enzima UGT1A1 i CYP3A)
English: Tel: + 385 16051 999
Croatian: GlaxoSmithKline d.o.o. Tel: + 385 16051 999
English: Dolutegravir ↓ AUC ↓ 49% Cmax ↓ 33% Cτ ↓ 73%
Croatian: Antikonvulzivi karbamazepin / dolutegravir dolutegravir ↓ AUC ↓ 49% Cmax ↓ 33% Cτ ↓ 73%
English: The recommended dose of dolutegravir is 50 mg twice daily for patients taking etravirine without boosted protease inhibitors.
Croatian: Za bolesnike koji uzimaju etravirin bez pojačanih inhibitora proteaze preporučena doza dolutegravira iznosi 50 mg dvaput na dan.
English: No dosage adjustment is considered necessary for patients with mild to moderate hepatic impairment.
Croatian: Ne smatra se potrebnim prilagođavati dozu u bolesnika s blagim do umjerenim oštećenjem jetrene funkcije Utjecaj teškog oštećenja jetrene funkcije na farmakokinetiku dolutegravira nije se ispitivao.
English: Discontinued for other reasons and ≥50 copies/mL
Croatian: Prekid liječenja zbog nedostatne djelotvornosti Prekid liječenja zbog drugih razloga dok je vrijednost bila ≥ 50 kopija/ml
English: Fosamprenavir↔ Ritonavir ↔ (induction of UGT1A1 and CYP3A enzymes)
Croatian: fosamprenavir↔ ritonavir ↔ (indukcija enzima UGT1A1 i CYP3A)
English: Hypersensitivity reactions have been reported with dolutegravir, and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including severe liver reactions.
Croatian: sustavnim simptomima te ponekad poremećajem funkcije organa, uključujući teške jetrene reakcije.
English: When administered in fasted state, bioequivalence regarding Cmax was achieved for dolutegravir, when comparing Dovato to dolutegravir 50 mg co-administered with lamivudine 300 mg. Dolutegravir AUC0-t was 16% higher for Dovato than for dolutegravir 50 mg co-administered with lamivudine 300 mg.
Croatian: Kod primjene natašte postignuta je bioekvivalentnost s obzirom na Cmax dolutegravira između lijeka Dovato i dolutegravira u dozi od 50 mg primijenjenog istodobno s lamivudinom u dozi od 300 mg.
English: Liver chemistry elevations consistent with immune reconstitution syndrome were observed in some hepatitis B and/or C co-infected patients at the start of dolutegravir therapy.
Croatian: U nekih bolesnika s istodobnom infekcijom virusom hepatitisa B i/ili C su na početku liječenja dolutegravirom primijećena povišenja vrijednosti biokemijskih parametara jetrene funkcije koja odgovaraju sindromu imunološke rekonstitucije.
English: Monitoring of liver chemistries is recommended in patients with hepatitis B and/or C co-infection.
Croatian: U bolesnika s istodobnom infekcijom virusom hepatitisa B i/ili C preporučuje se praćenje biokemijskih parametara jetrene funkcije (vidjeti odlomak
English: The recommended dose of dolutegravir is 50 mg twice daily when co-administered with nevirapine.
Croatian: Kod istodobne primjene s nevirapinom preporučena doza dolutegravira iznosi 50 mg dvaput na dan.
English: The recommended dose of dolutegravir is 50 mg twice daily when co-administered with rifampicin.
Croatian: Kod istodobne primjene s rifampicinom preporučena doza dolutegravira iznosi 50 mg dvaput na dan.
English: Dolutegravir
Croatian: Učinak dolutegravira:
English: Table 3
Croatian: PRILOG III.
English: Metformin ↑ Dolutegravir ↔ When co-administered with dolutegravir 50 mg QD:
Croatian: Antidijabetici metformin / dolutegravir metformin ↑ dolutegravir ↔ Kad se primjenjuje istodobno s dolutegravirom u dozi od 50 mg jedanput na dan: metformin
English: Antacids and supplements
Croatian: OBLIK I SADRŽAJ
English: Consider more frequent monitoring of HIV-1 viral load when chronic coadministration cannot be avoided.
Croatian: Ako se dugotrajna istodobna primjena tih lijekova ne može izbjeći, potrebno je razmotriti češće praćenje količine virusa HIV-1 u krvi.
English: Miscellaneous
Croatian: Antacidi
English: • muscle or joint aches.
Croatian: • bolovi u mišićima ili zglobovima
English: fatigue
Croatian: Nuspojava
English: Cmax ↑ 16% Cτ ↓ 30% (induction of UGT1A1 and CYP3A enzymes)
Croatian: rifabutin / dolutegravir dolutegravir ↔ AUC ↓ 5% Cmax ↑ 16% Cτ ↓ 30% (indukcija enzima UGT1A1 i CYP3A)
English: As Dovato is a fixed-dose tablet, an additional 50 mg tablet of dolutegravir should be administered, approximately 12 hours after Dovato for the duration of the tipranavir/ritonavir co-administration (a separate formulation of dolutegravir is available for this dose adjustment, see section 4.2).
Croatian: Budući da je Dovato tableta s fiksnom kombinacijom doza, tijekom cijelog razdoblja istodobnog liječenja tipranavirom/ritonavirom potrebno je uzimati dodatnu tabletu dolutegravira od 50 mg, približno 12 sati nakon lijeka Dovato (za tu je prilagodbu doze dostupna zasebna formulacija dolutegravira, vidjeti dio 4.2).
English: → Talk to your doctor for further advice on taking acid-lowering medicines with Dovato.
Croatian: → Za dodatne savjete o uzimanju lijeka Dovato zajedno s lijekovima koji smanjuju količinu kiseline u želucu razgovarajte sa svojim liječnikom.
English: Elderly
Croatian: ranitidin
English: A separate preparation of dolutegravir is available where a dose adjustment is indicated due to drug-drug interactions (e.g. rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St. John's wort, etravirine (without boosted protease inhibitors), efavirenz, nevirapine, or tipranavir/ritonavir, see sections 4.4 and 4.5).
Croatian: Dostupna je zasebna formulacija dolutegravira za slučajeve kada je potrebna prilagodba doze zbog interakcija s drugim lijekovima (npr. rifampicinom, karbamazepinom, okskarbazepinom, fenitoinom,
English: Sorbitol
Croatian: laktacidoza
English: When co-administered with dolutegravir 50 mg BID:
Croatian: Kad se primjenjuje istodobno s dolutegravirom u dozi od 50 mg dvaput na dan:
English: The recommended dose of dolutegravir is 50 mg twice daily when co-administered with efavirenz.
Croatian: Kod istodobne primjene s efavirenzom preporučena doza dolutegravira iznosi 50 mg dvaput na dan.
English: PHARMACEUTICAL FORM AND CONTENTS 30 tablets.
Croatian: 30 tableta.
English: The recommended dose of dolutegravir is 50 mg twice daily when co-administered with these metabolic inducers.
Croatian: Nakon primjene dolutegravira u dozi od 50 mg jedanput na dan u odraslih ispitanika s HIV-1
English: As Dovato is a fixed-dose tablet, an additional 50 mg tablet of dolutegravir should be administered, approximately 12 hours after Dovato for the duration of the rifampicin co-administration (a separate formulation of dolutegravir is available for this dose adjustment, see section 4.2).
Croatian: Dovato tableta s fiksnom kombinacijom doza, tijekom cijelog razdoblja istodobnog liječenja rifampicinom potrebno je uzimati dodatnu tabletu dolutegravira od 50 mg, približno 12 sati nakon lijeka Dovato (za tu je prilagodbu doze dostupna zasebna formulacija dolutegravira, vidjeti dio 4.2).
English: As Dovato is a fixed-dose tablet, an additional 50 mg tablet of dolutegravir should be administered, approximately 12 hours after Dovato for the duration of the etravirine without boosted protease inhibitor co-administration (a separate formulation of dolutegravir is available for this dose adjustment, see section
Croatian: Budući da je Dovato tableta s fiksnom kombinacijom doza, tijekom cijelog razdoblja istodobnog liječenja etravirinom bez pojačanih inhibitora proteaze potrebno je uzimati dodatnu tabletu dolutegravira od 50 mg, približno 12 sati nakon lijeka Dovato (za tu je prilagodbu doze dostupna zasebna formulacija dolutegravira, vidjeti dio 4.2).
English: As Dovato is a fixed-dose tablet, an additional 50 mg tablet of dolutegravir should be administered, approximately 12 hours after Dovato for the duration of the efavirenz co-administration (a separate formulation of dolutegravir is available for this dose adjustment, see section 4.2).
Croatian: Dovato tableta s fiksnom kombinacijom doza, tijekom cijelog razdoblja istodobnog liječenje efavirenzom potrebno je uzimati dodatnu tabletu dolutegravira od 50 mg, približno 12 sati nakon lijeka Dovato (za tu je prilagodbu doze dostupna zasebna formulacija dolutegravira, vidjeti dio 4.2).
English: Dolutegravir ↔ AUC ↑ 1% Cmax ↓ 3% Cτ ↓ 8% Tenofovir ↔
Croatian: Nukleozidni inhibitori reverzne transkriptaze (engl. nucleoside reverse transcriptase inhibitor, NRTI) tenofovirdizoproksil emtricitabin, didanozin, stavudin, tenofoviralafenamid, zidovudin dolutegravir ↔ AUC ↑ 1% Cmax ↓ 3% Cτ ↓ 8% tenofovir ↔
English: Do not take an antacid during the 6 hours before you take Dovato, or for at least 2 hours after you take it. You can take other acid-lowering medicines like ranitidine and omeprazole at the same time as Dovato.
Croatian: Nemojte uzimati antacid unutar 6 sati prije primjene lijeka Dovato ni najmanje 2 sata nakon njegove primjene.
English: As Dovato is a fixed-dose tablet, an additional 50 mg tablet of dolutegravir should be administered, approximately 12 hours after Dovato for the duration of the nevirapine co-administration (a separate formulation of dolutegravir is available for this dose adjustment, see section 4.2).
Croatian: Dovato tableta s fiksnom kombinacijom doza, tijekom cijelog razdoblja istodobnog liječenja nevirapinom potrebno je uzimati dodatnu tabletu dolutegravira od 50 mg, približno 12 sati nakon lijeka Dovato (za tu je prilagodbu doze dostupna zasebna formulacija dolutegravira, vidjeti dio 4.2).
English: Similar IC50s were seen for clinical isolates without any major difference between subtypes; in a panel of 24 HIV-1 isolates of clades A, B, C, D, E, F and G and group O the mean IC50 value was 0.2 nM (range 0.02-2.14).
Croatian: HIV-1 iz skupina A, B, C, D, E, F i G te skupine
English: CI 95% for HR
Croatian: CI 95 % za HR
English: Please read the instructions carefully and follow them step by step.
Croatian: Pažljivo pročitajte upute i slijedite ih korak po korak.
English: You may see an air bubble, and that is okay.
Croatian: Možete primijetiti mjehurić zraka, i to je u redu.
English: Open.
Croatian: Otvorite.
English: • Several seconds later you may hear a 2nd click.
Croatian: • Nakon nekoliko sekundi možete čuti drugi klik.
English: There is no reason to remove it.
Croatian: Nema ga potrebe ukloniti.
English: You may hear a 1st click.
Croatian: Možete čuti prvi klik.
English: Median Time to Failure (months)
Croatian: Medijan vremena do neuspjeha (mjeseci)
English: Be careful that it does not fall over.
Croatian: Pazite da ne padne.
English: Wait 15-30 minutes
Croatian: Pričekajte 15-30 minuta
English: • Make sure you know the proper amount (volume) needed for dosing.
Croatian: • Budite sigurni da znate točnu količinu (volumen) potrebnu za doziranje.
English:  Remember to wash your hands!
Croatian:  Ne zaboravite oprati ruke!
English: Age over 65 years
Croatian: Osobe starije od 65 godina
English: Sometimes, fast injections can be painful.
Croatian: Brzo ubrizgavanje ponekad može biti bolno.
English: • The needle is clean.
Croatian: • Igla je čista.
English: Fewer than half of at-risk subjects had an event
Croatian: Manje od polovice bolesnika pod rizikom imalo je događaj.
English: Not known (frequency cannot be estimated from available data):
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka):
English: It is normal to see a few drops of liquid come out of the needle.
Croatian: Normalno je vidjeti nekoliko kapljica tekućine kako izlazi iz igle.
English: This may mean there is an infection and therefore you should contact your doctor.
Croatian: Ovo može značiti da postoji infekcija te se zato obratite svom liječniku.
English: Additional risk minimisation measures
Croatian: • Dodatne mjere minimizacije rizika
English: - Not applicable
Croatian: - nije primjenjivo
English: Maintenance Dose Starting at Week 4
Croatian: Doza održavanja počevši od 4. tjedna
English: ATC code: L04AB04
Croatian: ATK oznaka: L04AB04
English: Fatty areas, like your stomach, are generally the best injection sites.
Croatian: Takva područja, kao npr. na trbuhu, su općenito najbolja mjesta za ubrizgavanje.
English: (See section 4.5).
Croatian: (vidjeti dio 4.5).
English: N Failure N
Croatian: N Neuspjeh N
English: If there is a second box in the carton for a future injection, place it back in the refrigerator immediately.
Croatian: Ako je u kartonskom pakiranju još jedna kutija za iduću injekciju, odmah je vratite u hladnjak.
English: • Throw away all other used items into your regular household waste.
Croatian: • Sve druge iskorištene predmete bacite u obični kućanski otpad.
English: ASASa 40 ASAS 20 ASAS 5/6 ASAS partial remission BASDAIb 50
Croatian: ASASa 40 ASAS 20 ASAS 5/6 ASAS djelomična remisija BASDAI
English: Dose + 0.1 ml
Croatian: Doza + 0.1 ml
English: After proper training, the injection can be self-administered or given by another person, for example a family member or friend.
Croatian: Nakon primjerene obuke, injekciju možete dati sami ili je može dati druga osoba, primjerice član obitelji ili prijatelj.
English: • When you push down, the injection starts.
Croatian: • Kada pritisnete prema dolje ubrizgavanje počinje.
English: Among those, 109 subjects (63.7 %) were reported to be in remission at 10 years.
Croatian: Za 109 od tih ispitanika (63,7 %) prijavljeno je da su bili u remisiji nakon 10 godina.
English: NEVER pull past the 0.9 ml position regardless of prescribed dose.
Croatian: NIKADA ne vucite preko položaja od 0,9 ml bez obzira na propisanu dozu.
English: Not sure if you received your dose?
Croatian: Niste sigurni da ste primili svoju dozu?
English: Other medicines and Imraldi
Croatian: Drugi lijekovi i Imraldi
English: DO NOT use any item after the date shown on the box.
Croatian: NE koristite niti jedan dio pribora nakon datuma navedenog na kutiji.
English: • severe allergic reaction with shock;
Croatian: • teška alergijska reakcija uz šok;
English: • nervous system problems
Croatian: • problemi živčanog sustava
English: In rare cases, these infections may be life-threatening.
Croatian: U rijetkim slučajevima, ove infekcije mogu biti opasne po život.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim nepodnošenjem fruktoze ne bi smijeli uzimati ovaj lijek.
English: Double-Blind Response at Week 68
Croatian: Dvostruko slijepo Odgovor u 68. tjednu