FrancophonIA/ELRC3.0 huggingface dataset:
English: You need to keep taking it every day to stop your illness getting worse.
Croatian: Uvijek nastojite uzimati terapiju svakodnevno kako se bolest ne bi pogoršala.
English: ALERT CARD TEXT SIDE 1
Croatian: TEKST KARTICE S UPOZORENJEM 1. STRANA
English: Slowly push the plunger in, allowing time to swallow.
Croatian: Polako gurajte klip, omogućujući vrijeme za gutanje.
English: Common: rash (without systemic symptoms)
Croatian: Često: osip (bez sistemskih simptoma)
English: After first opening the container: 2 months
Croatian: 2 godine Nakon prvog otvaranja spremnika: 2 mjeseca
English: No additional adverse reactions to those reported for normal doses were reported.
Croatian: Nije bila prijavljena nijedna dodatna nuspojava u odnosu na one prijavljene za normalnu dozu.
English: Talk to your doctor immediately.
Croatian: Odmah razgovarajte sa svojim liječnikom.
English: Safety Concern
Croatian: Sigurnosni problem
English: Your methadone dose may need to be changed.
Croatian: Dozu metadona će možda trebati prilagoditi (promijeniti).
English: The bottle is inverted and the correct volume withdrawn.
Croatian: Boca se okrene i povuče se točan volumen.
English: If you are breast-feeding, or thinking about breast-feeding:
Croatian: Ako dojite ili ste razmišljali o dojenju:
English: • if they are also taking anti-inflammatory medicines called corticosteroids
Croatian: • ako su isto tako uzimali protuupalne lijekove nazvane kortikosteroidi
English: While the carcinogenic potential in humans is unknown, these data suggest that a carcinogenic risk to humans is outweighed by the potential clinical benefit.
Croatian: Iako kancerogeni potencijal u ljudi nije poznat, ovi podaci ukazuju da potencijalna klinička korist nadmašuje kancerogeni rizik u ljudi.
English: Not everyone responds to treatment with Ziagen in the same way.
Croatian: Ne odgovaraju svi bolesnici na liječenje lijekom Ziagen na isti način.
English: Conclusions supported non-inferiority regardless of analysis method.
Croatian: Zaključci su potvrđivali neinferiornost neovisno o metodi analize.
English: Ziagen does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level.
Croatian: Ziagen ne liječi u potpunosti infekciju HIV-a, već smanjuje količinu virusa u tijelu i održava je na niskoj razini.
English: Tell your doctor if you have heart problems, if you smoke, or have other illnesses that may increase your risk of heart disease such as high blood pressure, or diabetes.
Croatian: Obavijestite liječnika ako imate problema sa srcem, ako pušite ili imate bolest koja može povisiti rizik za srčanu bolest kao što je visoki krvni tlak ili dijabetes.
English: Your doctor will check whether your symptoms were related to a hypersensitivity reaction.
Croatian: Liječnik će provjeriti da li su simptomi povezani s reakcijom preosjetljivosti.
English: Sorbitol can have a mild laxative effect.
Croatian: Sorbitol može imati blagi laksativni učinak.
English: Contents of the pack and other information What Ziagen contains
Croatian: Sadržaj pakiranja i druge informacije Što Ziagen sadrži
English: If your doctor is not available, you must urgently seek alternative medical advice (e.g. the emergency unit of the nearest hospital).
Croatian: Ako Vaš liječnik nije dostupan, hitno potražite savjet drugog liječnika ( npr. hitni prijem najbliže liječničke ustanove).
English: • if you have ever had liver disease, including hepatitis B or C • if you are seriously overweight (especially if you are a woman)
Croatian: • ako ste ikada bolovali od bolesti jetre, uključujući hepatitis B ili C • ako ste ozbiljno pretili (posebice ako ste žena)
English: Retinoids: retinoid compounds are eliminated via alcohol dehydrogenase.
Croatian: Retinoidi: Retinoidni spojevi eliminiraju se putem alkohol dehidrogenaze.
English: Food delayed absorption and decreased Cmax but did not affect overall plasma concentrations (AUC).
Croatian: Hrana odgađa apsorpciju i smanjuje Cmax, ali ne utječe na sveukupnu koncentraciju u plazmi (AUC).
English: Swallow the tablets with some water.
Croatian: Tabletu progutajte s vodom.
English: Many of the adverse reactions have not been treatment limiting.
Croatian: Mnoge od nuspojava nisu ograničavale liječenje.
English: What Ziagen looks like and contents of the pack
Croatian: Kako Ziagen izgleda i sadržaj pakiranja
English: You may still develop other infections and illnesses linked to HIV infection.
Croatian: No, i nadalje možete razviti druge infekcije ili bolesti povezane s HIV infekcijom.
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 povišeni rizik od primjene lijeka.
English: • methadone used as a heroin substitute.
Croatian: • metadon, kao nadomjesna terapija za heroin.
English: Clinical diagnosis of suspected hypersensitivity to ABC remains the basis for clinical decision making.
Croatian: Klinička dijagnoza suspektne preosjetljivost na ABC ostaje temelj kliničkog odlučivanja.
English: If you have taken Ziagen during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Croatian: Ako ste Ziagen uzimali tijekom trudnoće, postoji mogućnost da liječnik zatraži redovito provođenje pretraga krvi i drugih dijagnostičkih pretraga kako bi pratio razvoj vašega djeteta.
English: These findings are not considered clinically significant.
Croatian: Ovi nalazi se ne smatraju klinički značajnim.
English: If you have stopped taking Ziagen because of a hypersensitivity reaction, you must NEVER AGAIN
Croatian: Ako ste prestali uzimati Ziagen zbog reakcije preosjetljivosti, ne smijete NIKADA VIŠE uzimati
English: Interaction with abacavir is possible but has not been studied.
Croatian: Interakcija s abakavirom je moguća, ali nije ispitivana.
English: Pregnancy Ziagen is not recommended for use during pregnancy.
Croatian: Ziagen se ne preporučuje za primjenu tijekom trudnoće.
English: CD4 cells are a type of white blood cell that are important in helping your body to fight infection.
Croatian: CD4 stanice su vrsta bijelih krvnih stanica koje imaju važnu ulogu pomaganja organizmu da se obrani od infekcije.
English: The systemic exposures were equivalent to 7 to 24 times the expected systemic exposure in humans.
Croatian: Sistemska izloženost bila je ekvivalentna 7 do 24 puta većoj od predviđene izloženosti u ljudi.
English: Do not take other medicines for the infection without your doctor's advice.
Croatian: Ne uzimajte druge lijekove za infekciju prije nego li se savjetujete s liječnikom.
English: Do not take Ziagen:
Croatian: Nemojte uzimati Ziagen:
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 sa jednom djelatnom tvari, ZIAGEN (SAD prosinac 1998, EU srpanj 1999).
English: Sodium hydroxide and/or hydrochloric acid for pH adjustment.
Croatian: natrijev hidroksid i/ili kloridna kiselina za podešavanje pH.
English: Date of first authorisation: 8 July 1999 Date of latest renewal: 21 March 2014
Croatian: Datum posljednje obnove: 21. ožujka 2014.
English: Symptoms of infection and inflammation Old infections may flare up
Croatian: Simptomi infekcije i upale Stare infekcije mogu se razbuktati
English: Ziagen helps to control your condition.
Croatian: Ziagen Vam pomaže da kontrolirate stanje bolesti.
English: Ziagen and similar medicines may cause side effects in unborn babies.
Croatian: Ziagen i slični lijekovi mogu uzrokovati nuspojave u nerođene djece.
English: If you have stopped taking Ziagen for any reason - especially because you think you are having side effects, or because you have other illness:
Croatian: Ako ste prekinuli uzimati Ziagen zbog bilo kojeg razloga - posebice zato što mislite da imate nuspojave ili neku drugu bolest:
English: Of note, from this study clinical data were not available for children under one year old.
Croatian: Važno je napomenuti da iz tog ispitivanja nisu bili dostupni klinički podaci za djecu mlađu od 1 godine.
English: Plasma abacavir exposure has been shown to be the same for both formulations when administered at the same dose.
Croatian: Pokazalo se da je izloženost abakaviru jednaka uz obje formulacije kada se one primjenjuju u istoj dozi.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Detach enclosed Alert Card, it contains important safety information
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Odvojite priloženu Karticu s upozorenjem, jer sadrži važne sigurnosne informacije.
English: The following convention has been used for their classification: 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).
Croatian: Klasificirane su prema učestalosti: vrlo često (>1/10), često (>1/100 do <1/10), manje često (>1/1000 do <1/100), rijetko (>1/10 000 do <1/1000),
English: • skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
Croatian: • kožni osip, koji može stvarati mjehuriće na koži i izgledati kao male mete (tamne točke u središtu, okružene svijetlim područjem s tamnim prstenom na rubu) (erythema multiforme)
English: The tablet can be divided into equal doses.
Croatian: Tableta se može podijeliti na jednake doze.
English: The mean half-life of abacavir is about 1.5 hours.
Croatian: Eliminacija Srednje poluvrijeme abakavira je oko 1,5 sati.
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 i nastavite sa terapijom kao prije.
English: For general Ziagen information enquiries, contact GlaxoSmithKline….Tel …………… (local company name and telephone number will be inserted here).
Croatian: Za općenite upite vezane uz Ziagen, kontaktirajte GlaxoSmithKline ….Tel: …………(naziv lokalne tvrtke i telefonski broj će biti navedeni ovdje).
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajem fruktoze ne bi trebali uzimati ovaj lijek.
English: • presence of skin rash; OR
Croatian: • pojave kožnog osipa; ILI
English: Driving and using machines
Croatian: Upravljanje vozilima ili strojevima
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 dijete putem majčina mlijeka.
English: A small amount of the ingredients in Ziagen can also pass into your breast milk.
Croatian: Mala količina sastojaka lijeka Ziagen također može prijeći u majčino mlijeko.
English: When taken according to the dosage recommendations each 15 ml dose contains approximately 5 g of sorbitol.
Croatian: Kada se primjenjuje u preporučenim dozama svaka doza od 15 ml sadrži oko 5 g sorbitola.
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 kasnije u ovom dijelu pod naslovom “Ostale moguće nuspojave u kombiniranoj terapiji za HIV”.
English: The Cmax value for the oral solution is slightly higher than the tablet.
Croatian: Vrijednost Cmax za oralnu otopinu je nešto viša nego za tablete.
English: With this condition, parts of the bone tissue die because of reduced blood supply to the bone.
Croatian: U tom stanju dijelovi koštanog tkiva odumiru zbog smanjene opskrbe kostiju krvlju.
English: You are more likely to develop such a reaction if you have the HLA-B*5701 gene (but you can get a reaction even if you do not have this gene).
Croatian: Pojava takve reakcije je vjerojatnija ako imate gen pod nazivom HLA-B*5701 (iako možete dobiti ovakvu reakciju i ako nemate taj gen).
English: If you are caring for a child who is being treated with Ziagen, it is important that you understand the information about this hypersensitivity reaction.
Croatian: Ako se brinete za dijete koje je na terapiji lijekom Ziagen, važno je da razumijete informacije o reakciji preosjetljivosti.
English: If you accidentally take too much Ziagen, tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.
Croatian: Ako slučajno uzmete previše lijeka Ziagen, obavijestite svog liječnika, ljekarnika, ili se javite za savjet u hitnu službu najbliže bolnice.
English: Therapy Abacavir + Combivir1
Croatian: Terapija Abakavir + Combivir1
English: Children less than three months of age: The clinical experience in children aged less than three months is limited and are insufficient to propose specific dosage recommendations (see section 5.2).
Croatian: Djeca mlađa od 3 mjeseca: Kliničko iskustvo s primjenom lijeka u djece mlađe od 3 mjeseca je ograničeno i nedostatno za davanje specifičnih preporuka za doziranje (vidjeti dio 5.2).
English: Abacavir has also been shown in vitro not to inhibit CYP 3A4, CYP2C9 or CYP2D6 enzymes at clinically relevant concentrations.
Croatian: Također je dokazano in vitro da abakavir ne inhibira enzime CYP 3A4, CYP 2C9 ili CYP 2D6 u klinički relevantnim koncentracijama.
English: Due to the high proportion of premature discontinuation (42% of patients discontinued randomised treatment by week 48), no definitive conclusion can be drawn regarding the equivalence between the treatment regimens at week 48.
Croatian: Zbog visokog udjela bolesnika koji su prijevremeno prekinuli liječenje (42% bolesnika prekinulo je randomizirano liječenje do 48. tjedna), ne mogu se izvući konačni zaključci što se tiče ekvivalencije ispitivanih režima liječenja do 48. tjedna.
English: What you need to know before you take Ziagen
Croatian: Što morate znati prije nego počnete uzimati Ziagen
English: The absolute bioavailability of oral abacavir in adults is about 83%.
Croatian: Apsolutna bioraspoloživost oralnog oblika abakavira u odraslih iznosi oko 83%.
English: Abacavir has no effect on the metabolism of ethanol.
Croatian: Abakavir nema učinak na metabolizam etanola.
English: You should immediately contact your doctor if you think you are having a hypersensitivity reaction to Ziagen.
Croatian: Odmah obavijestite svog liječnika ako smatrate da imate reakciju preosjetljivosti na Ziagen.
English: Ziagen film-coated tablets are engraved with ‘GX 623' on both sides.
Croatian: Ziagen filmom obložene tablete imaju otisnutu oznaku ''GX 623' na obje strane.
English: In addition, the 69 insertion complex or the Q151M mutation, usually found in combination with A62V, V75I, F77L and F116Y, cause a high level of resistance to abacavir.
Croatian: Osim toga, insercijski kompleks na mjestu 69 ili mutacija Q151M, koja se obično nalazi u kombinaciji s A62V, V75I, F77L i F116Y, uzrokuju visoku razinu rezistencije na abakavir.
English: Cross-resistance between abacavir and antiretrovirals from other classes (e.g. PIs or NNRTIs) is unlikely.
Croatian: Križna rezistencija između abakavira i antiretrovirusnih lijekova iz drugih skupina (npr. IP ili NNRTI) nije vjerojatna.
English: This conclusion is based on the physiochemical and pharmacokinetic data, assuming that the patient crushes and transfers 100% of the tablet and ingests immediately.
Croatian: Ovi se zaključci temelje na fizikalno-kemijskim i farmakokinetičkim podacima pod pretpostavkom da je bolesnik izdrobio te odmah uzeo 100 % tablete.
English: In this study, addition of ABC to ZDV/3TC/EFV did not significantly improve efficacy.
Croatian: U toj studiji dodatak ABC shemi ZDV/3TC/EFV nije značajno poboljšao djelotvornost.
English: Administration of crushed tablets with a small amount of semi-solid food or liquid would not be expected to have an impact on the pharmaceutical quality, and would therefore not be expected to alter the clinical effect.
Croatian: Primjena drobljene tablete s malom količinom kašaste hrane ili tekućine, ne bi trebala utjecati na farmaceutsku kakvoću, pa se ne očekuje niti promjena kliničkog učinka.
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.cstavkom 7. Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
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 tjedana terapije.
English: Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking Ziagen.
Croatian: Zapamtite da svakako obavijestite svog liječnika ili ljekarnika ako započnete uzimati nove lijekove dok istovremeno uzimate Ziagen.
English: Viral resistance to abacavir develops relatively slowly in vitro, requiring multiple mutations for a clinically relevant increase in EC50 over wild-type virus.
Croatian: Virusna rezistencija na abakavir razvija se relativno sporo in vitro, te zahtijeva višestruke mutacije za klinički relevantan porast u EC50 u odnosu na divlji soj virusa.
English: The changes in abacavir pharmacokinetics are not considered clinically relevant.
Croatian: Promjene u farmakokinetici abakavira ne smatraju se klinički značajnima.
English: If you take more Ziagen than you should
Croatian: Ako uzmete više lijeka Ziagen nego što ste trebali
English: Close the bottle tightly with the cap, leaving the adapter in place
Croatian: Zatvorite bocu čvrsto sa zatvaračem, ostavljajući nastavak na mjestu.
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 put metabolizma u čovjeka odvija se pomoću alkohol dehidrogenaze i glukuronidacije, te se pri tome stvara 5'-karboksilna kiselina i 5'-glukuronid koji čine oko 66% primijenjene doze.
English: Data from clinical trials showed limited numbers of myocardial infarction and could not exclude a small increase in risk.
Croatian: Podaci iz kliničkih ispitivanja pokazali su ograničen broj infarkta miokarda, te se nije moglo isključiti malo povišenje rizika.
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 majke zaražene HIV-om ni u kom slučaju ne doje, kako bi se izbjegao prijenos virusa HIV.
English: Very rare: erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis
Croatian: Vrlo rijetko: erythema multiforme, Stevens-Johnsonov sindrom i toksična epidermalna nekroliza
English: This medicine contains the sweetener sorbitol (approximately 5g in each 15 ml dose), which may have a mild laxative effect.
Croatian: Ovaj lijek sadrži sladilo sorbitol ( oko 5 g u jednoj dozi od 15 ml), koja može imati blagi laksativni učinak.
English: Symptoms usually appeared within the first six weeks (median time to onset 11 days) of initiation of treatment with abacavir, although these reactions may occur at any time during therapy.
Croatian: Simptomi su se obično javljali unutar prvih šest tjedana (medijan vremena do nastupa iznosio je 11 dana) nakon početka liječenja abakavirom, iako se te reakcije mogu pojaviti u bilo kojem trenutku tijekom liječenja.
English: Overall, these data support the use of abacavir 600 mg once daily for the treatment of HIV infected patients.
Croatian: Općenito, ovi podaci podupiru primjenu abakavira u dozi od 600 mg jedanput na dan u liječenju bolesnika s HIV infekcijom.
English: If you know you have this gene, tell your doctor before you take Ziagen.
Croatian: Ako znate da imate taj gen, obavijestite svog liječnika prije uzimanja lijeka Ziagen.
English: Hypersensitivity to abacavir or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na abakavir ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: The degree of benefit as part of a new combination regimen will depend on the nature and duration of prior therapy which may have selected for HIV-1 variants with cross-resistance to abacavir.
Croatian: Stupanj koristi kao dijela nove kombinacije ovisi o prirodi i trajanju prethodnog liječenja, koje je moglo izabrati HIV-1 varijante s križnom rezistencijom na abakavir.
English: Virologic failure (HIV RNA >200 copies/ml)
Croatian: Virološki neuspjeh (HIV RNA >200 kopija/ml)
English: Abacavir and its metabolites are excreted into the milk of lactating rats.
Croatian: Abakavir i njegovi metaboliti se izlučuju u mlijeko štakora u laktaciji.
English: Patients receiving Ziagen or any other antiretroviral therapy may still develop opportunistic infections and other complications of HIV infection.
Croatian: Bolesnici koji uzimaju Ziagen ili bilo koju drugu antiretrovirusnu terapiju, mogu i dalje razvijati oportunističke infekcije i druge komplikacije HIV infekcije.
English: These results indicate that abacavir has a weak potential to cause chromosomal damage both in vitro and in vivo at high test concentrations.
Croatian: Ovi rezultati ukazuju da abakavir ima slab potencijal da uzrokuje oštećenje kromosoma i in vivo i in vitro u visokim koncentracijama prilikom testiranja.
English: Some people taking combination therapy for HIV develop a condition called osteonecrosis.
Croatian: Neki bolesnici koji uzimaju terapiju za HIV razvijaju stanje koje se zove osteonekroza.
English: Other signs and symptoms that have been observed as part of abacavir HSR are described in detail in section 4.8 (Description of selected adverse reactions), including respiratory and gastrointestinal symptoms.
Croatian: Drugi znakovi i simptomi primijećeni kao dio reakcija preosjetljivosti na abakavir detaljno su opisani u dijelu 4.8 (Opis odabranih nuspojava), uključujući respiratorne i gastrointestinalne simptome.
English: In case of any symptoms suggesting hypersensitivity reactions, contact your doctor IMMEDIATELY.
Croatian: U slučaju bilo kojih simptoma reakcije preosjetljivosti, ODMAH kontaktirajte svog liječnika.
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 3-7 puta veća od sistemske izloženosti u ljudi tijekom liječenja.
English: The EU RMP of the abacavir (ABC) containing products (Ziagen, Kivexa and Trizivir) includes the following risk minimisation plan in relation to abacavir hypersensitivitiy reaction (HSR), which is an important identified risk:
Croatian: EU RMP za lijekove koji sadrže abakavir (ABC) (Ziagen, Kivexa i Trizivir) uključuje sljedeći plan minimalizacije rizika vezano uz reakcije preosjetljivosti (HSR) na abakavir, koje predstavljaju važan identificirani rizik.
English: Studies in HIV infected patients have shown good penetration of abacavir into the CSF, with a CSF to plasma AUC ratio of between 30 to 44%.
Croatian: Ispitivanja na bolesnicima zaraženim HIV-om pokazala su dobro prodiranje abakavira u CSF, s omjerom AUC-a u CSF u odnosu na plazmu između 30 do 44%.
English: • Additional risk minimisation measures
Croatian: Dodatne mjere minimalizacije rizika
English: A 10 ml oral dosing syringe and a plastic adapter for the bottle are included in the pack.
Croatian: Štrcaljka za oralno doziranje od 10 ml i plastični nastavak za bocu su uključeni u pakiranje.
English: Abacavir has been shown to be carcinogenic in animal models (see section 5.3).
Croatian: Abakavir se pokazao kancerogenim u životinjskim modelima (vidjeti dio 5.3).