FrancophonIA/ELRC3.0 huggingface dataset:
English: Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Croatian: Znakovi osteonekroze su ukočenost zglobova, bolovi (osobito u kuku, koljenu i ramenu) i poteškoće pri kretanju.
English: These metabolites are essentially inactive against HIV-1.
Croatian: Ti metaboliti u pravilu ne djeluju protiv HIV-1 virusa.
English: any signs of skin rash.
Croatian: bilo kakve znakove kožnog osipa.
English: *,†,‡ See section Description of selected adverse reactions for more details.
Croatian: *,†,‡ Vidjeti dio Opis odabranih nuspojava za detaljnije informacije.
English: Body Weight
Croatian: Tjelesna težina
English: It is recommended that the tablet be swallowed whole with water.
Croatian: Preporučuje se tabletu progutati cijelu s vodom.
English: Clinical experience in controlled studies with combinations including didanosine or zalcitabine is limited.
Croatian: Klinička iskustva iz kontroliranih ispitivanja kombinacija koje su uključivale didanozin ili zalcitabin su ograničena.
English: astemizole or terfenadine (used to treat allergy symptoms)
Croatian: astemizol ili terfenadin (za liječenje simptoma alergije)
English: Autoimmune disorders may occur many months after the start of treatment.
Croatian: Autoimuni poremećaji mogu se javiti više mjeseci nakon početka liječenja.
English: This medicine is not a cure for HIV infection and you may continue to develop infections or other illnesses associated with HIV disease.
Croatian: Ovaj lijek neće izliječiti HIV infekciju te se i dalje mogu nastaviti razvijati infekcije ili druge bolesti povezane s HIV bolešću.
English: Efavirenz may remain in your blood for a time after therapy is stopped.
Croatian: Efavirenz može ostati u krvi neko vrijeme nakon završetka liječenja.
English: The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Croatian: Duljina trajanja kombiniranog antiretrovirusnog liječenja, uzimanje kortikosteroida, konzumiranje alkohola, jaka imunosupresija, veći indeks tjelesne mase mogu, između ostalog, biti neki od brojnih rizičnih čimbenika za razvoj ove bolesti.
English: (inhibition of CYP-mediated oxidative metabolism)
Croatian: (inhibicija oksidativnog metabolizma posredovanog izoenzimima CYP-a)
English: 7 Carefully pull the cap away from the body of the capsule (illustration c).
Croatian: 7 Pažljivo odvojite kapicu od tijela kapsule (ilustracija c).
English: Pharmacokinetic studies have not been performed in the elderly.
Croatian: Nisu provedena farmakokinetička ispitivanja u starijih osoba.
English: 13 Stir to make sure there is no drug residue remaining in the container (illustration e).
Croatian: 13 Pomiješajte kako biste se uvjerili da nema ostataka lijeka u posudi (ilustracija e).
English: Insufficient numbers of elderly patients have been evaluated in clinical studies to determine whether they respond differently than younger patients.
Croatian: Klinička ispitivanja nisu provedena na dovoljnom broju starijih bolesnika da bi se moglo utvrditi razlikuje li se njihov odgovor na liječenje od onoga u mlađih bolesnika.
English: if you have a heart disorder, such as abnormal electrical signal called prolongation of the QT interval.
Croatian: ako imate srčani poremećaj, kao što je neuobičajeni električni signal, koji se naziva produljenje QT intervala.
English: For a summary of clinical and pharmacodynamic information, see section 5.1.
Croatian: Za sažetak kliničkih i farmakodinamičkih podataka vidjeti dio 5.1.
English: If you are taking any of these medicines, your doctor may need to check the level of anticonvulsant medicine in your blood to ensure that it is not affected while taking SUSTIVA.
Croatian: Ako uzimate bilo koji od ovih lijekova, liječnik će Vam možda morati provjeriti razinu antikonvulzivnog lijeka u krvi kako bi bio siguran da se nije promijenila zbog uzimanja lijeka SUSTIVA.
English: The clinical effect of this dose adjustment has not been adequately evaluated.
Croatian: Klinički učinak ove prilagodbe doze nije dostatno procijenjen.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje gotovog lijeka u promet:
English: You must remain under the care of your doctor while taking SUSTIVA.
Croatian: Morate ostati pod nadzorom svog liječnika dok uzimate lijek SUSTIVA.
English: Similar elevations were seen in patients treated with control regimens (5% after long-term treatment).
Croatian: Slični porasti opaženi su u bolesnika liječenih kontrolnim protokolom (5% nakon dugotrajnog liječenja).
English: Frequency is defined using the following convention: 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); or very rare (< 1/10,000).
Croatian: Učestalost nuspojava definirana je sljedećim izrazima: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000) i vrlo rijetko
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 antivirusne terapije za liječenje hepatitisa B ili C treba proučiti i relevantne informacije za te lijekove.
English: The incidence of neural tube defects in the general population ranges from 0.5-1 case per 1,000 live births.
Croatian: Incidencija oštećenja neuralne cijevi u općoj populaciji iznosi 0,5 do 1 slučaj na 1000 živorođene djece.
English: Alternatives to clarithromycin (e.g. azithromycin) may be considered.
Croatian: Može se razmotriti primjena alternative klaritromicinu (npr. azitromicin).
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate ili ste nedavno uzimali ili biste mogli uzeti bilo koje druge lijekove.
English: It is recommended that the capsule be swallowed whole with water.
Croatian: Preporučuje se kapsule progutati cijele s vodom.
English: This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves.
Croatian: To je djelomično povezano s poboljšanim zdravljem i stilom života, dok je u slučaju lipida u krvi katkad povezano i s lijekovima za liječenje HIV-a.
English: If you take these two medicines together, the dose of voriconazole must be increased and the dose of efavirenz must be reduced.
Croatian: Ako uzimate ova dva lijeka zajedno, doza vorikonazola mora se povećati, a doza efavirenza mora se smanjiti.
English: What you need to know before you take SUSTIVA
Croatian: Što morate znati prije nego počnete uzimati lijek SUSTIVA
English: These immunosuppressants are not anticipated to affect exposure of efavirenz.
Croatian: Ne očekuje se da će ovi imunosupresivi utjecati na izloženost efavirenzu.
English: Interaction not studied.
Croatian: Interakcija nije ispitivana.
English: Once you start taking SUSTIVA, look out for:
Croatian: Nakon što počnete uzimati lijek SUSTIVA, obratite pozornost na:
English: Mean AUC(0-24) µM·h
Croatian: Srednja vrijednost AUC(0-24) µM·h
English: Warnings and precautions Talk to your doctor before taking SUSTIVA
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije nego uzmete lijek SUSTIVA.
English: Medicinal product by therapeutic areas (dose)
Croatian: Lijekovi po terapijskim područjima (doza)
English: Taking into account the PRAC Assessment Report on the PSUR(s) for efavirenz, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za efavirenz, znanstveni zaključci CHMP-a su sljedeći:
English: If any antiretroviral medicinal product in a combination regimen is interrupted because of suspected intolerance, serious consideration should be given to simultaneous discontinuation of all antiretroviral medicinal products.
Croatian: Ako se prekine primjena jednog od antiretrovirusnih lijekova u kombiniranoj terapiji zbog sumnje na nepodnošenje, mora se ozbiljno razmotriti istodobni prekid liječenja svim antiretrovirusnim lijekovima.
English: 6 With your hands over the container, hold the capsule with the cap facing up (see illustration b).
Croatian: 6 S rukama iznad posude, držite kapsulu u položaju s kapicom okrenutom prema gore (vidjeti ilustraciju b).
English: For the drug-drug interaction with etonogestrel implant, the PRAC noted the available data from 16 case reports and the published literature articles by Vieira et al., 2014 and Chappel et al., 2017.
Croatian: Vezano za interakciju lijek-lijek s implantatom koji sadrži etonogestrel, PRAC je razmotrio dostupne podatke iz 16 prijava slučajeva i objavljenih literaturnih članaka Vieire i sur., 2014. i Chappela i sur., 2017.
English: Tell your doctor if you notice any of the following side effects:
Croatian: Obavijestite svog liječnika ako primijetite neku od sljedećih nuspojava:
English: Carcinogenicity studies showed an increased incidence of hepatic and pulmonary tumours in female mice, but not in male mice.
Croatian: Istraživanja kancerogenosti pokazala su povećanu incidenciju jetrenih i plućnih tumora u ženki miševa, ali ne i u mužjaka.
English: 10 Mix the capsule contents and food together (illustration e).
Croatian: 10 Pomiješajte sadržaj kapsule i hranu (ilustracija e).
English: Therefore, you should continue to use contraceptive measures, as above, for 12 weeks after you stop taking SUSTIVA.
Croatian: Stoga, morate nastaviti koristiti kontracepcijske metode kako je gore navedeno još 12 tjedana nakon prestanka uzimanja lijeka SUSTIVA.
English: Cholesterol levels should be periodically monitored.
Croatian: Razine kolesterola moraju se periodički kontrolirati.
English: Efavirenz exposure may be increased when given with medicinal products (for example, ritonavir) or food (for example, grapefruit juice), which inhibit CYP3A4 or CYP2B6 activity.
Croatian: Izloženost efavirenzu može se povećati kada se primjenjuje s lijekovima (npr. ritonavirom) ili hranom (npr. sokom od grejpa) koji inhibiraju aktivnost CYP3A4 ili CYP2B6.
English: Sertraline dose increases should be guided by clinical response.
Croatian: Pri povišenju doze sertralina treba se voditi kliničkim odgovorom.
English: If you are affected, do not drive and do not use any tools or machines.
Croatian: Ako primijetite opisane učinke, nemojte voziti niti raditi sa strojevima ili s alatima.
English: This proportion is approximately 3-fold higher than the nonprotein-bound (free) fraction of efavirenz in plasma.
Croatian: Taj je udio približno triput veći od udjela slobodne frakcije efavirenza (koja se ne veže za proteine) u plazmi.
English: If you need help in planning the best times to take your medicine, ask your doctor or pharmacist.
Croatian: Ako trebate pomoć u planiranju najpogodnijeg vremena za uzimanje lijeka, obratite se svom liječniku ili ljekarniku.
English: As neural tube defects occur within the first 4 weeks of foetal development (at which time neural tubes are sealed), this potential risk would concern women exposed to efavirenz during the first trimester of pregnancy.
Croatian: Budući da do oštećenja neuralne cijevi dolazi u prva 4 tjedna razvoja ploda (kada se neuralna cijev zatvara), ovaj potencijalni rizik odnosi se na žene koje su izložene efavirenzu u prvom tromjesečju trudnoće.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and pneumonia caused by Pneumocystis jiroveci (formerly known as Pneumocystis carinii).
Croatian: Relevantni primjeri su citomegalovirusni retinitis, generalizirane i/ili fokalne infekcije mikobakterijama i pneumonija uzrokovana uzročnikom Pneumocystis jiroveci (ranije poznatim kao Pneumocystis carinii).
English: In addition, your doctor may prescribe a higher dose of SUSTIVA.
Croatian: Osim toga, liječnik Vam može propisati veću dozu lijeka SUSTIVA.
English: Opening the capsule and taking the contents with a small amount of food may be considered for children who cannot swallow the hard capsule.
Croatian: Otvaranje kapsule i uzimanje sadržaja s malom količinom hrane može se dozvoliti u djece koja ne mogu progutati tvrdu kapsulu.
English: Patients taking drugs that are known to prolong the QTc interval (proarrythmic).
Croatian: Bolesnici koji uzimaju lijekove za koje se zna da produljuju QTc interval (proaritmici).
English: If you have taken SUSTIVA or the combination tablet containing efavirenz, emtricitabine, and tenofovir during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Croatian: Ako ste tijekom trudnoće uzimali SUSTIVA ili kombiniranu tabletu koja sadrži efavirenz, emtricitabin i tenofovir, Vaš liječnik može zatražiti redovne krvne i druge dijagnostičke pretrage kako bi pratio razvoj Vašeg djeteta.
English: There is insufficient information on the effects of efavirenz in newborns/infants.
Croatian: Nema dovoljno podataka o učinku efavirenza na novorođenčad/dojenčad.
English: Psychiatric symptoms
Croatian: Psihijatrijski simptomi
English: The mixture should be administered as soon as possible, but no more than 30 minutes after mixing.
Croatian: Mješavina se treba uzeti što je prije moguće, a najkasnije 30 minuta nakon miješanja.
English: Antiviral activity
Croatian: Antivirusna aktivnost
English: Ketoconazole and other imidazole antifungals
Croatian: ketokonazol i drugi imidazolski antimikotici
English: BATCH NUMBER Lot
Croatian: 4. BROJ SERIJE Lot
English: Therefore, efavirenz should not be given to children less than 3 months of age.
Croatian: Stoga se efavirenz ne smije davati djeci mlađoj od 3 mjeseca.
English: If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Croatian: Primijetite li bilo koji simptom infekcije ili druge simptome poput slabosti mišića, slabosti koja počinje u šakama i stopalima i podiže se prema trupu tijela, osjećaj lupanja srca, nevoljno drhtanje ili hiperaktivnost, molimo odmah o tome obavijestite svog liječnika radi potrebnog liječenja.
English: Efavirenz is highly bound (approximately 99.5 - 99.75%) to human plasma proteins, predominantly albumin.
Croatian: Efavirenz se u velikoj mjeri veže za proteine plazme (približno 99,5-99,75%), pretežno za albumin.
English: Taking SUSTIVA on an empty stomach may reduce the undesirable effects.
Croatian: Uzimanjem lijeka SUSTIVA na prazan želudac mogu se smanjiti nuspojave.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 May 1999
Croatian: Datum prvog odobrenja: 28. svibnja 1999.
English: An updated RMP should be submitted:
Croatian: AžuriraRMP treba dostaviti:
English: Verapamil, Felodipine, Nifedipine and Nicardipine
Croatian: verapamil, felodipin, nifedipin i nikardipin
English: Efavirenz regimen (n=1,008)
Croatian: režim s efavirenzom (n=1008)
English: Therapy should be initiated by a physician experienced in the management of HIV infection.
Croatian: Liječenje mora započeti liječnik s iskustvom u liječenju bolesnika s HIV infekcijom.
English: Undesirable effects in children were generally similar to those of adult patients.
Croatian: Nuspojave u djece bile su uglavnom slične onima zabilježenima u odraslih bolesnika.
English: In vitro efavirenz is also an inhibitor of CYP3A4.
Croatian: In vitro, efavirenz je također inhibitor CYP3A4.
English: Dosing at bedtime seems to improve the tolerability of these symptoms and can be recommended during the first weeks of therapy and in patients who continue to experience these symptoms (see section 4.2).
Croatian: Uzimanje lijeka prije spavanja može poboljšati podnošljivost ovih simptoma te se može preporučiti u prvim tjednima liječenja, kao i za bolesnike u kojih se simptomi ne povlače (vidjeti dio 4.2).
English: When efavirenz was given with ritonavir 500 mg or 600 mg twice daily, the combination was not well tolerated (for example, dizziness, nausea, paraesthesia and elevated liver enzymes occurred).
Croatian: Kad se efavirenz davao s ritonavirom u dozi od 500 mg ili 600 mg dvaput na dan, ta se kombinacija nije dobro podnosila (na primjer, javile su se omaglica, mučnina, parestezija i povišene vrijednosti jetrenih enzima).
English: Dose related increases in Cmax and AUC were seen for doses up to 1,600 mg; the increases were less than proportional suggesting diminished absorption at higher doses.
Croatian: O dozi ovisno povišenje Cmax i AUC zabilježeno je kod primjene doza do 1600 mg; povišenja su bila manja od proporcionalnih, što upućuje na smanjenu apsorpciju lijeka pri višim dozama.
English: The standard doses of NRTIs given every 12 hours were used in each of these studies.
Croatian: U svakom od ovih ispitivanja davale su se standardne doze NRTI-ja svakih 12 sati.
English: Patients should be monitored carefully for dose-related adverse reactions, especially nervous system symptoms (see sections 4.3 and 4.4).
Croatian: Bolesnike treba pažljivo pratiti zbog mogućih nuspojava ovisnih o dozi, osobito simptoma živčanog sustava (vidjeti dijelove 4.3 i 4.4).
English: If you see any signs of a severe rash with blistering or fever, stop taking SUSTIVA and tell your doctor at once.
Croatian: Ako opazite bilo kakve znakove jakog osipa s mjehurićima ili vrućicom, odmah prestanite uzimati lijek SUSTIVA i javite se svom liječniku.
English: It is important to tell your doctor or pharmacist if you are taking any of the following:
Croatian: Važno je da obavijestite svog liječnika ili ljekarnika ako uzimate neke od sljedećih lijekova:
English: Because of the long half-life of efavirenz, use of adequate contraceptive measures for 12 weeks after discontinuation of efavirenz is recommended.
Croatian: Zbog dugog poluvijeka efavirenza, preporučuje se primjena odgovarajućih kontracepcijskih metoda tijekom 12 tjedana nakon prestanka uzimanja efavirenza.
English: It is an antiretroviral medicine that fights human immunodeficiency virus (HIV-1) infection by reducing the amount of the virus in blood.
Croatian: To je antiretrovirusni lijek koji suzbija infekciju virusom humane imunodeficijencije (HIV-1) tako što smanjuje količinu virusa u krvi.
English: SUSTIVA taken in combination with other antiretroviral medicines reduces the amount of the virus in the blood.
Croatian: Uzimanje lijeka SUSTIVA u kombinaciji s drugim antiretrovirusnim lijekovima smanjuje količinu virusa u krvi.
English: The daily dose of rifabutin should be increased by 50% when administered with efavirenz.
Croatian: Dnevnu dozu rifabutina mora se povećati za 50% kad se primjenjuje s efavirenzom.
English: if you have a history of mental illness, including depression, or of substance or alcohol abuse.
Croatian: ako ste bolovali od psihičkih bolesti, uključujući depresiju, ili ste bili ovisni o drogama ili alkoholu.
English: You must check with your doctor first.
Croatian: Najprije morate provjeriti sa svojim liječnikom. - itrakonazol.
English: Patients and caregivers must be instructed to open the capsule carefully to avoid spillage or dispersion of the capsule contents into the air.
Croatian: Bolesnicima i skrbnicima mora se objasniti da kapsulu treba pažljivo otvoriti kako bi spriječili rasipanje ili raspršenje sadržaja kapsule u zrak.
English: Although limited data suggest that females as well as Asian and Pacific Island patients may have higher exposure to efavirenz, they do not appear to be less tolerant of efavirenz.
Croatian: Premda ograničeni podaci pokazuju da je izloženost efavirenzu viša u žena, kao i u Azijata i bolesnika s tihooceanskih otoka, čini se da u njih ne postoji razlika u podnošljivosti efavirenza.
English: When treating HIV infection, it is not always possible to tell whether some of the unwanted effects are caused by SUSTIVA or by other medicines that you are taking at the same time, or by the HIV disease itself.
Croatian: Kod liječenja HIV infekcije nije uvijek moguće procijeniti jesu li neke nuspojave nastale zbog primjene lijeka SUSTIVA ili drugih lijekova koji se istodobno uzimaju, ili zbog same HIV bolesti.
English: No dose adjustment is necessary for efavirenz when given with indinavir or indinavir/ritonavir.
Croatian: Nije potrebno prilagođavati dozu efavirenza kad se daje s indinavirom ili indinavirom/ritonavirom.
English: cells/mm (S.E.M.
Croatian: stanica/mm (S.E.M.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
English: If you are affected your doctor may suggest that you take SUSTIVA at bedtime and on an empty stomach.
Croatian: Ako se u Vas pojave opisani simptomi, liječnik Vam može predložiti da lijek SUSTIVA uzimate prije spavanja i na prazan želudac.
English: In these studies, efavirenz did not impair mating or fertility of male or female rats (doses up to 100 mg/kg/bid), and did not affect sperm or offspring of treated male rats (doses up to 200 mg/bid).
Croatian: U tim ispitivanjima efavirenz nije poremetio parenje ni plodnost mužjaka i ženki štakora (doze do 100 mg/kg/dvaput na dan) i nije utjecao na spermu niti potomke liječenih mužjaka štakora (doze do 200 mg/dvaput na dan).
English: Efavirenz is not recommended for patients who have had a life-threatening cutaneous reaction (e.g., Stevens-Johnson syndrome) while taking another NNRTI.
Croatian: Efavirenz se ne preporučuje bolesnicima koji su imali po život opasnu kožnu reakciju (npr. Stevens-Johnsonov sindrom) tijekom uzimanja nekog drugog NNRTI-ja.
English: If you stop taking SUSTIVA
Croatian: Ako prestanete uzimati lijek SUSTIVA
English: Cross resistance profiles for efavirenz, nevirapine and delavirdine in cell culture demonstrated that the K103N substitution confers loss of susceptibility to all three NNRTIs.
Croatian: Profili križne rezistencije za efavirenz, nevirapin i delavirdin u staničnim kulturama pokazali su da zamjena K103N dovodi do gubitka osjetljivosti na sva tri NNRTI-ja.
English: Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Croatian: U nekih bolesnika koji uzimaju kombiniranu antiretrovirusnu terapiju može se razviti bolest kostiju koja se zove osteonekroza (propadanje koštanog tkiva zbog prestanka opskrbe kostiju krvlju).
English: Laboratory tests should be performed to evaluate their liver disease at periodic intervals (see section 4.2).
Croatian: Laboratorijske pretrage moraju se provesti u periodičkim intervalima radi procjene njihove bolesti jetre (vidjeti dio 4.2).
English: Despite the decrease in buprenorphine exposure, no patients exhibited withdrawal symptoms.
Croatian: Usprkos smanjenoj izloženosti buprenorfinu, ni jedan bolesnik nije imao simptome ustezanja.
English: HDPE bottles with a child-resistant polypropylene closure.
Croatian: HDPE bočice s polipropilenskim sigurnosnim zatvaračem za djecu.
English: A positive relationship between efavirenz concentration and QTc prolongation was observed.
Croatian: Opažen je pozitivan odnos između koncentracije efavirenza i produljenja QTc intervala.
English: In such patients, interruption or discontinuation of treatment must be considered (see section 4.8).
Croatian: U tih se bolesnika mora razmotriti privremeni ili trajni prekid liječenja (vidjeti dio 4.8).