FrancophonIA/ELRC3.0 huggingface dataset:
English: ABC HSR Education Programme has been in place since the first approval of ABC as the single active preparation, ZIAGEN (USA December 1998, EU July 1999).
Croatian: ABC HSR edukacijski program je važeći od prvog dobivenog odobrenja za ABC kao lijek s jednom djelatnom tvari (ZIAGEN (USA prosinac 1998, EU lipanj 1999).
English: These may affect up to 1 in 100 people and may show up in blood tests:
Croatian: Mogu se pojaviti u manje od 1 na 100 osoba i mogu se pokazati u krvnim pretragama:
English: The systemic exposures were equivalent to 7 to 24 times the expected systemic exposure in humans.
Croatian: Sistemska izloženost bila je 7 do 24 puta veća od predviđene sistemske izloženosti u ljudi.
English: To date, there is no established biological mechanism to explain a potential increase in risk.
Croatian: Do danas nije razjašnjen biološki mehanizam koji bi objasnio potencijalno povećani rizik od primjene lijeka.
English: Includes three non-virological failures and four unconfirmed virological failures.
Croatian: Uključujući tri neuspjeha nevirusnog karaktera i 4 nepotvrđena izostanka virološkog odgovora.
English: Abacavir + Combivir1
Croatian: Abakavir + Combivir1
English: Cases of pancreatitis have been reported
Croatian: Zabilježeni su slučajevi pankreatitisa
English: Common: Headache, insomnia.
Croatian: Često: glavobolja, nesanica.
English: KIVEXA TABLETS ALERT CARD SIDE 1
Croatian: KIVEXA TABLETE KARTICA S UPOZORENJEM STRANA 1
English: If you know you have this gene, tell your doctor before you take Kivexa.
Croatian: Ako znate da imate taj gen, obavijestite svog liječnika prije uzimanja lijeka Kivexa.
English: Sorbitol solution (3.2 g, 10.2 g, 13.4 g)/ Lamivudine
Croatian: otopina sorbitola (3.2 g, 10.2 g, 13.4 g)/lamivudin
English: If you are hypersensitive to Kivexa, return all your unused Kivexa tablets for safe disposal.
Croatian: Ako ste preosjetljivi na lijek Kivexa, vratite sve neiskorištene tablete na sigurno odlaganje.
English: What Kivexa contains
Croatian: Što Kivexa sadrži
English: The absolute bioavailability of lamivudine (approximately 58 to 66%) was lower and more variable in paediatric patients under 12 years of age.
Croatian: Apsolutna bioraspoloživost lamivudina (oko 58 do 66%) bila je niža i varijabilnija u pedijatrijskih bolesnika mlađih od 12 godina.
English: • if you have moderate or severe liver disease
Croatian: • ako imate umjerenu ili tešku bolest jetre
English: Overall response
Croatian: Ukupni odgovor
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 HIV-pozitivne ne smiju dojiti zbog toga što se HIV infekcija može prenijeti na bebu putem majčina mlijeka.
English: Clinical diagnosis of suspected hypersensitivity to ABC remains the basis for clinical decision making.
Croatian: Klinička dijagnoza suspektne preosjetljivosti na ABC ostaje temelj za donošenje kliničkih odluka.
English: TDF/FTC + LPV/r (N = 345) Week 48 Week 96 Week 48 Week 96
Croatian: TDF/FTC + LPV/r (N = 345) Tjedan 48 Tjedan 96 Tjedan 48 Tjedan 96
English: Antiviral Activity in vitro
Croatian: Antivirusna aktivnost in vitro
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Croatian: Ako postoje dokazi o pogoršanju bolesti jetre u tih bolesnika, treba razmotriti privremeni ili trajni prekid liječenja.
English: Virologic Response
Croatian: Virološki odgovor
English: Tell your doctor or pharmacist if you are taking any other medicines, or if you have taken any recently, including herbal medicines or other medicines you bought without a prescription.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzimali bilo koje druge lijekove uključujući biljne lijekove i druge lijekove koje ste kupili bez recepta.
English: Talk to your doctor before you start again.
Croatian: Javite se svom liječniku prije nego je ponovno počnete uzimati.
English: • presence of skin rash; OR
Croatian: • Pojave kožnog osipa; ILI
English: However, their main antiviral activity is through incorporation of the monophosphate form into the viral DNA chain, resulting in chain termination.
Croatian: Međutim, njihovo glavno protuvirusno djelovanje odvija se kroz inkorporiranje monofosfatnog oblika u lanac virusne DNK, što rezultira prekidom tog lanca.
English: The EU SPC provides detailed information and advice relating to ABC HSR
Croatian: SPC daje detaljne informacije i savjete vezane uz ABC HSR
English: If you have taken Kivexa during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Croatian: Ako ste lijek Kivexa uzimali tijekom trudnoće, postoji mogućnost da liječnik zatraži redovito provođenje pretraga krvi i drugih dijagnostičkih pretraga kako bi pratio razvoj vašega djeteta.
English: You are more likely to develop this reaction if you have a gene called HLA-B*5701 (but you can get a reaction even if you do not have this gene).
Croatian: Prije ćete razviti takvu reakciju ako imate gen pod nazivom HLA-B*5701 (ali možete dobiti ovakvu reakciju i ako nemate taj gen).
English: IMPORTANT - ALERT CARD Kivexa (abacavir / lamivudine) tablets Carry this card with you at all times
Croatian: VAŽNO - KARTICA S UPOZORENJEM Kivexa (abakavir / lamivudin) tablete Ovu karticu uvijek nosite sa sobom
English: Zidovudine, didanosine, stavudine and tenofovir maintain their antiretroviral activities against such HIV-1 variants.
Croatian: Zidovudin, didanozin, stavudin i tenofovir održavaju antiretrovirusnu aktivnost protiv takvih varijanti HIV-1.
English: • a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than
Croatian: • široko rasprostranjen osip s mjehurićima i ljuštenjima kože, posebice oko usta, nosa, očiju i genitalija (Stevens-Johnsonov sindrom) i u težim oblicima koji uzrokuju ljuštenje kože u više od
English: • if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, do not stop Kivexa without your doctor's advice, as your hepatitis may come back)
Croatian: • ako ste nekada imali bolest jetre, uključujući hepatitis B ili C (ako imate infekciju virusom hepatitisa B nemojte prestajati uzimati lijek Kivexa bez prethodnog savjetovanja sa svojim liječnikom, jer bi se hepatitis mogao vratiti)
English: Possible interaction given common pathway of elimination via alcohol dehydrogenase.
Croatian: Moguća interakcija zbog zajedničkog puta eliminacije alkoholdehidrogenazom.
English: There are no additional precautions and warnings relevant to Kivexa.
Croatian: Nema dodatnih mjera opreza i upozorenja relevantnih za lijek Kivexa.
English: Abacavir is rapidly and well absorbed from oral formulations when administered to children.
Croatian: Abakavir se brzo i dobro apsorbira iz oralnih formulacija kad se primjenjuje djeci.
English: Additionally, the efficacy and safety of this combination given once daily has been demonstrated in a pivotal clinical study (CNA30021- See Clinical experience).
Croatian: Osim toga, djelotvornost i neškodljivost ove kombinacije primijenjene jedanput na dan dokazana je i u pivotalnoj kliničkoj studiji (CNA30021- vidjeti Kliničko iskustvo).
English: No additional safety issues have been identified in paediatric subjects receiving either once or twice daily dosing compared to adults.
Croatian: Nisu identificirana dodatna sigurnosna pitanja u pedijatrijskih ispitanika koji su primali dozu jedanput ili dvaput na dan u usporedbi s odraslim osobama.
English: A small amount of the ingredients in Kivexa can also pass into your breast milk.
Croatian: Mala količina sastojaka lijeka Kivexa također može prijeći u majčino mlijeko.
English: Kivexa and similar medicines may cause side effects in unborn babies.
Croatian: Kivexa i slični lijekovi mogu uzrokovati nuspojave u nerođene djece.
English: It is important that you follow this advice.
Croatian: Važno je da slijedite savjet liječnika.
English: Methadone dosage adjustment unlikely in majority of patients; occasionally methadone re-titration may be required.
Croatian: Potreba za prilagođavanjem doze za metadon je malo vjerojatna kod većine bolesnika; povremeno je potrebna retitracija metadona.
English: Lamivudine has not shown any genotoxic activity in the in vivo studies at doses that gave plasma concentrations up to 40-50 times higher than clinical plasma concentrations.
Croatian: Lamivudin nije pokazao nikakvu genotoksičnu aktivnost u studijama in vivo pri dozama koje uzrokuju koncentracije u plazmi do 40-50 puta više od kliničkih koncentracija.
English: • a low red blood cell count (anaemia) or low white blood cell count (neutropenia)
Croatian: • nizak broj crvenih krvnih stanica (anemija) ili nizak broj bijelih krvnih stanica (neutropenija)
English: Objective and rationale: Increased understanding and awareness of ABC HSR.
Croatian: Cilj i argument: Bolje razumijevanje i povećana svijest vezano uz ABC HSR.
English: If you forget to take a dose, take it as soon as you remember.
Croatian: Ako zaboravite jednu dozu, uzmite je čim se sjetite, te nastavite s terapijom kao prije.
English: Based on the above patients are advised to contact their physician immediately to determine whether they should stop taking abacavir if:
Croatian: Temeljem gore navedenog, bolesnicima se preporučuje da se odmah obrate svojem liječniku kako bi se utvrdilo da li trebaju prestati uzimati abakavir u slučaju:
English: The primary efficacy analysis was performed at week 48 with study continuation to week 96 and demonstrated non-inferiority.
Croatian: Analiza primarne djelotvornosti je provedena u 48. tjednu s nastavkom ispitivanja do 96. tjedna te se nije pokazala inferiornom.
English: Write your doctor's details below:
Croatian: Zapišite podatke svog liječnika:
English: Rare: Rises in serum amylase.
Croatian: Rijetko: porast serumskih amilaza.
English: Do not take other medicines for the infection without your doctor's advice.
Croatian: Nemojte uzimati druge lijekove za infekciju prije nego li se savjetujete sa svojim liječnikom.
English: Always take this medicine exactly as your doctor has told you.
Croatian: Kako uzimati lijek Kivexa Uvijek uzimajte ovaj lijek točno onako kako Vam je rekao Vaš liječnik.
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Croatian: Svaki simptom upale se mora procijeniti i po potrebi započeti liječenje.
English: • fever (high temperature) and skin rash.
Croatian: • vrućica (visoka temperatura) i osip kože.
English: Your doctor may advise you to stop taking Kivexa.
Croatian: Vaš liječnik Vam može savjetovati da prestanete uzimati lijek Kivexa.
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Croatian: Iako je dokazano da učinkovita supresija virusa antiretrovirusnom terapijom značajno smanjuje rizik od prijenosa bolesti spolnim putem, ne može se isključiti rezidualni rizik.
English: If you are taking methadone, you will be checked for any withdrawal symptoms.
Croatian: Ako uzimate metadon, biti ćete nadzirani zbog razvoja simptoma odvikavanja.
English: Frequencies are defined as very common (> 1/10), common (> 1/100 to < 1/10), uncommon (> 1/1000 to < 1/100), rare (> 1/10,000 to < 1/1000), very rare
Croatian: česte (>1/100 i <1/10), manje česte (>1/1000 i <1/100), rijetke (>1/10 000 i <1/1000), vrlo rijetke
English: The most common symptoms are:
Croatian: Najčešći simptomi su:
English: If your doctor advises that you can start taking Kivexa again, you may be asked to take your first doses in a place where you will have ready access to medical care if you need it.
Croatian: Ako Vam je liječnik savjetovao da ponovno počnete uzimati lijek Kivexa, možda će Vas uputiti da prve doze uzmete na mjestu gdje Vam se u slučaju potrebe odmah može ukazati liječnička pomoć.
English: Studies with abacavir demonstrate a CSF to plasma AUC ratio of between 30 to 44%.
Croatian: Ispitivanja s abakavirom pokazuju omjer CST-a u odnosu na plazmatsku AUC između 30 do 44%.
English: Based on data obtained for abacavir, Kivexa is not recommended in patients with moderate or severe hepatic impairment.
Croatian: Na temelju podataka dobivenih za abakavir, Kivexa se ne preporučuje u bolesnika s umjerenim ili teškim oštećenjem jetre
English: It cannot be excluded that abacavir may increase the risk of having a heart attack.
Croatian: Ne može se isključiti da abakavir može povisiti rizik od nastanka srčanog napada.
English: Abacavir: AUC ↔ Cmax ↓35%
Croatian: abakavir: AUC ↔ Cmax ↓35%
English: The observed lamivudine half-life of elimination is 5 to 7 hours.
Croatian: Zabilježeno poluvrijeme eliminacije lamivudina iznosi 5 - 7 sati.
English: The likelihood of metabolic drug interactions with lamivudine is low due to the small extent of hepatic metabolism (5-10%).
Croatian: Vjerojatnost metaboličkih interakcija lamivudina s drugim lijekovima je mala zbog malog opsega metabolizma u jetri (5 - 10%).
English: Proposed actions: Provision of updated ABC HSR education materials for healthcare professionals to countries where the MAH has marketing authorisation for ABC.
Croatian: Predložene mjere: Dostavljanje ažuriranih edukacijskih materijala vezanih uz ABC HSR zdravstvenim djelatnicima u zemljama gdje nositelj odobrenja ima odobrenje za ABC.
English: Abbreviations: ↑ = Increase; ↓ = decrease; ↔ = no significant change; AUC = area under the concentration versus time curve; Cmax = maximum observed concentration; CL/F = apparent oral clearance
Croatian: Skraćenice: ↑ = povišenje; ↓ = sniženje; ↔ = bez značajne promjene; AUC =p odručje ispod krivulje koja označava omjer koncentracije u odnosu na vrijeme; Cmax = maksimalna promatrana koncentracija; CL/F = prividni oralni klirens
English: For general Kivexa information enquiries, contact [local company name and telephone number inserted here]
Croatian: Za općenite informacije o lijeku Kivexa kontaktirajte [ovdje navesti naziv i telefonski broj lokalne podružnice]
English: If you accidentally take too much Kivexa, tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.
Croatian: Ako slučajno uzmete previše tableta, obavijestite svog liječnika ili ljekarnika, ili se javite za savjet u hitnu službu najbliže bolnice.
English: • phenytoin, for treating epilepsy.
Croatian: • fenitoin za liječenje epilepsije.
English: The systemic exposure at the no effect level in mice and rats was equivalent to 3 and 7 times the human systemic exposure during therapy.
Croatian: Sistemska izloženost pri kojoj nije bilo nikakvog učinka u miševa i štakora bila je do 3 i 7 puta veća od sistemske izloženosti u ljudi tijekom terapije.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i objavljenima na europskom internetskom portalu za lijekove.
English: If you get any symptoms of infection and inflammation or if you notice any of the symptoms above: Tell your doctor immediately.
Croatian: Ako dobijete bilo koji simptom infekcije i upale ili ako primijetite neki od gore navedenih simptoma: Odmah obavijestite svog liječnika.
English: The primary pathways of metabolism in man are by alcohol dehydrogenase and by glucuronidation to produce the 5'-carboxylic acid and 5'-glucuronide which account for about 66% of the administered dose.
Croatian: Glavni putevi metabolizma u čovjeka odvijaju se pomoću alkohol dehidrogenaze i glukuronidacije te se pri tome stvaraju 5'-karboksilna kiselina i 5'-glukuronid, koji čine oko 66% primijenjene doze.
English: Tell your doctor if you are taking methadone.
Croatian: Obavijestite svog liječnika ako uzimate metadon.
English: The results are presented below:
Croatian: Rezultati su prikazani ispod:
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 više od 200 parova majka /dijete liječenih zbog HIV infekcije, serumske koncentracije lamivudina u dojenčadi čije su majke liječene zbog HIV infekcije su vrlo niske (< 4% serumskih koncentracija u majke) i progresivno se smanjuju do nemjerljivih razina nakon što dojenče navrši 24
English: • other medicinal products containing lamivudine, used to treat HIV infection or hepatitis B
Croatian: • drugi lijekovi koji sadrže lamivudin, za liječenje infekcije HIV-om ili hepatitisom B
English: What you need to know before you take Kivexa
Croatian: Što morate znati prije nego počnete uzimati lijek Kivexa
English: There are no data available on the safety of abacavir and lamivudine when administered to babies less than three months old.
Croatian: Nisu dostupni podaci o sigurnosti abakavira i lamivudina primijenjenih bebama mlađim od 3 mjeseca.
English: Symptoms can occur at any time during treatment with ABC, but usually occur within the first 6 weeks of therapy.
Croatian: Simptomi se mogu pojaviti u bilo koje vrijeme tijekom trajanja liječenja s ABC-om, no obično je to unutar prvih 6 mjeseci terapije.
English: Almost all patients developing hypersensitivity reactions will have fever and/or rash (usually maculopapular or urticarial) as part of the syndrome, however reactions have occurred without rash or fever.
Croatian: Gotovo svi bolesnici koji razviju reakcije preosjetljivosti imat će vrućicu i/ili osip (obično makulopapularni ili urtikarijski) kao dio sindroma, međutim reakcije su se javljale i bez osipa ili vrućice.
English: L74V Y115F M184V/I TAMs3
Croatian: K65R L74V Y115F M184V/I TAMs3
English: Talk to your doctor about your ability to drive or operate machines while taking Kivexa.
Croatian: Razgovarajte sa svojim liječnikom o Vašoj sposobnosti upravljanja vozilima ili rada sa strojevima dok uzimate lijek Kivexa.
English: Abacavir: AUC ↑41% Ethanol: AUC ↔
Croatian: abakavir: AUC ↑41% etanol: AUC ↔
English: Paediatric population: The safety and efficacy of Kivexa in children weighing less than 25 kg has not been established.
Croatian: Pedijatrijska populacija: Sigurnost i djelotvornost lijeka Kivexa u djece tjelesne težine manje od 25 kg nisu još ustanovljene.
English: • Emtricitabine, to treat HIV infection
Croatian: • emtricitabin, za liječenje infekcije HIV-om
English: Adults, adolescents and children weighing at least 25 kg:
Croatian: Odrasli, adolescenti i djeca tjelesne težine od najmanje 25 kg:
English: Therefore, patients with any of these symptoms should be carefully evaluated for the presence of this hypersensitivity (see section 4.4).
Croatian: Stoga u bolesnika s bilo kojim od tih simptoma treba pažljivo procijeniti eventualnu prisutnost preosjetljivosti (vidjeti dio 4.4).
English: Abacavir can cause a serious allergic reaction known as a hypersensitivity reaction.
Croatian: Abakavir može uzrokovati ozbiljnu alergijsku reakciju koja se naziva reakcijom preosjetljivosti.
English: The recommended dose of Kivexa for adults, adolescents and children weighing 25 kg or more is one tablet once a day.
Croatian: Preporučena doza lijeka Kivexa za odrasle, adolescente i djecu tjelesne težine 25 kg ili više je jedna tableta jedanput na dan.
English: No pharmacokinetic data are currently available in patients over 65 years of age.
Croatian: Trenutno nema dostupnih farmakokinetičkih podataka za bolesnike starije od 65 godina.
English: Keep in touch with your doctor, and do not stop taking Kivexa without your doctor's advice.
Croatian: Ostanite u kontaktu sa svojim liječnikom i nemojte prestati uzimati lijek Kivexa bez prethodnog savjetovanja s liječnikom.
English: The mean half-life of abacavir is about 1.5 hours.
Croatian: Srednji poluvijek abakavira je oko 1,5 sati.
English: When prescribing Kivexa, action should be taken to try to minimize all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia).
Croatian: Kivexa, potrebno je poduzeti akcije kako bi se smanjili svi potencijalni čimbenici rizika (npr. pušenje, hipertenzija i hiperlipidemija).
English: Routine risk minimisation activities
Croatian: Rutinske mjere minimalizacije rizika
English: It is important to read the information later in this section under ‘Other possible side effects of combination therapy for HIV'.
Croatian: Stoga je važno pročitati informacije navedene u ovom dijelu ispod, pod naslovom “Ostale moguće nuspojave u kombiniranoj terapiji za HIV”.
English: You need to know about important signs and symptoms to look out for while you are taking Kivexa.
Croatian: Zbog toga morate biti upoznati sa važnim znakovima i simptomima na koje treba obratiti pozornost prilikom uzimanja lijeka Kivexa.
English: These metabolites are excreted in the urine.
Croatian: Ti se metaboliti izlučuju u urinu.
English: In any case, initiation of susceptible NRTIs should always be preferred to maintenance of lamivudine therapy.
Croatian: U svakom slučaju, uvođenje osjetljivih NRTI-a treba uvijek imati prednost nad nastavkom liječenja lamivudinom.
English: It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Croatian: Preporučuje se da žene zaražene HIV-om ni pod kojim okolnostima ne doje svoju djecu, kako bi se spriječio prijenos HIV-a.
English: The frequency of this is unknown (see section 4.4).
Croatian: Učestalost ove pojave nije poznata (vidjeti dio 4.4).
English: Abacavir + lamivudine + PI (or PI/ritonavir)
Croatian: Abakavir + lamivudin + PI (ili PI/ritonavir)
English: The active ingredients of Kivexa may inhibit cellular DNA replication and abacavir has been shown to be carcinogenic in animal models (see section 5.3).
Croatian: Djelatne tvari lijeka Kivexa mogu inhibirati replikaciju stanične DNK i abakavir se pokazao kancerogenim u životinjskim modelima (vidjeti dio 5.3).
English: Therefore, maintaining lamivudine therapy despite emergence of M184V mutation should only be considered in cases where no other active NRTIs are available.
Croatian: Stoga nastavak liječenja lamivudinom unatoč pojavi mutacije M184V treba razmotriti samo u slučajevima kad nisu dostupni drugi aktivni NRTI-i.
English: - The risk of virological failure with Kivexa might be higher than with other therapeutic options (see section 5.1).
Croatian: - Rizik od izostanka virološkog odgovora može biti viši u liječenju lijekom Kivexa nego u drugim opcijama liječenja (vidjeti dio 5.1).
English: Selection for the M184V mutation occurred first and resulted in a two fold increase in IC50.
Croatian: Prvo se dogodila selekcija M184V mutacije koja je rezultirala sa dvostruki povećanjem IC50.
English: If you are breast-feeding, or thinking about breast-feeding: Talk to your doctor immediately.
Croatian: Ako dojite ili ste razmišljali o dojenju: Odmah razgovarajte sa svojim liječnikom.
English: No pharmacokinetic data are available in patients over 65 years of age.
Croatian: Nisu dostupni farmakokinetski podaci u bolesnika starijih od 65 godina.
English: There are no data on the use of Kivexa in pregnancy, however the malformative risk is unlikely in humans based on those data.
Croatian: Nema podataka o primjeni lijeka Kivexa u trudnica, ali na temelju ovih podataka rizik malformacija u ljudi nije vjerojatan.
English: Median Change vRNA (log10 c/mL)
Croatian: Medijan promjene vRNK (log10 c/mL)