FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ziagen on 8 July 1999.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Ziagen na snazi u Europskoj uniji od 8. srpnja 1999.
English: Other information about Ziagen:
Croatian: Ostale informacije o lijeku Ziagen:
English: The recommended dose of Ziagen for adults and children weighing at least 25 kg is 600 mg daily.
Croatian: Preporučena doza lijeka Ziagen za odrasle i djecu tjelesne mase od najmanje 25 kg iznosi 600 mg dnevno.
English: In one of the studies in adults, 77% of the patients taking Ziagen with lamivudine and zidovudine had viral loads below 400 copies/ml after 16 weeks (67 out of 87), compared with 38% of the adults taking lamivudine and zidovudine without Ziagen (33 out of 86).
Croatian: U jednom od ispitivanja na odraslim osobama, 77 % bolesnika koji su uzimali Ziagen s lamivudinom i zidovudinom imalo je virusno opterećenje niže od 400 kopija/ml nakon 16 tjedana (67 od 87), u usporedbi s 38 % odraslih osoba koje su uzimale lamivudin i zidovudin bez Ziagena (33 od 86).
English: Hypersensitivity reactions (allergic reactions) occur in patients taking Ziagen, usually within the first six weeks of treatment, and can be life-threatening.
Croatian: Reakcije preosjetljivosti (alergijske reakcije) nastupaju u bolesnika koji uzimaju lijek Ziagen obično unutar prvih šest tjedana terapije i mogu biti opasne po život.
English: Symptoms almost always include fever or rash, but also very commonly include nausea, vomiting, diarrhoea, abdominal pain (stomach ache), dyspnoea (difficulty breathing), cough, fever, lethargy, malaise (feeling unwell), headache, signs of liver damage in the blood and myalgia (muscle pain).
Croatian: Simptomi gotovo uvijek uključuju groznicu ili osip, no također vrlo često obuhvaćaju mučninu, povraćanje, proljev, abdominalnu bol (bol u trbuhu), dispneju (otežano disanje), kašalj, vrućicu, letargiju, malaksalost (osjećaj zamaranja), glavobolju, znakove oštećenja jetre u krvi i mijalgiju (bol u mišićima).
English: It was more effective than placebo, and was as effective as other antiviral medicines in reducing viral loads in all age groups.
Croatian: Bio je djelotvorniji od placeba te je bio podjednako djelotvoran kao drugi antivirotici u smanjivanju virusnog opterećenja u svim dobnim skupinama.
English: In addition, the company that markets Ziagen provides educational materials for doctors about hypersensitivity reactions with the medicine, including the need to test patients for the HLA-B (type 5701) gene and to remind patients to contact their doctor immediately if they develop symptoms suggestive of hypersensitivity.
Croatian: Nadalje, tvrtka koja stavlja u promet lijek Ziagen dostavit će edukacijske materijale liječnicima o reakcijama preosjetljivosti na lijek, uključujući potrebu za testiranje bolesnika na gen HLA-B (tip 5701) i upozorenje bolesnicima da se odmah obrate svojem liječniku ako razviju simptome koji upućuju na preosjetljivost.
English: What measures are being taken to ensure the safe and effective use of Ziagen?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ziagen?
English: The main measures of effectiveness were the levels of HIV in the blood (viral load) and the number of CD4 T-cells in the blood (CD4 cell count).
Croatian: Glavno mjerilo djelotvornosti bile su koncentracije HIV-a u krvi (virusno opterećenje) i broj CD4 Tstanica u krvi (broj CD4 stanica).
English: The CHMP noted that the demonstration of the benefit of Ziagen was based on the results of studies mainly carried out with the medicine taken twice a day in combination with other medicines in adults who had not taken HIV treatment before.
Croatian: CHMP je zaključio da je demonstracija koristi lijeka Ziagen utemeljena na rezultatima ispitivanja koja su uglavnom provedena s tim lijekom koji je uziman dvaput dnevno u kombinaciji s drugim lijekovima u odraslih osoba koje ranije nisu uzimale terapiju protiv HIV-a.
English: Patients who cannot swallow tablets should use the oral solution, or alternatively they may crush the tablets and add them to a small amount of food or drink immediately before swallowing it. For more information, see the package leaflet.
Croatian: Bolesnici koji ne mogu progutati tabletu trebaju uzimati oralnu otopinu ili mogu usitniti tablete i dodati ih u male količine hrane ili pića neposredno prije gutanja.
English: This document is a summary of the European Public Assessment Report (EPAR) for Ziagen.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Ziagen.
English: A risk management plan has been developed to ensure that Ziagen is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Ziagen.
English: Before starting treatment with abacavir, all patients should have a test to find out if they have a gene called ‘HLA-B (type 5701)'.
Croatian: Prije početka terapije abakavirom svi se bolesnici trebaju testirati kako bi se utvrdilo imaju li gen „HLA-B (tip 5701)”.
English: Ziagen, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Croatian: Ziagen primijenjen u kombinaciji s drugim antivirusnim lijekovima smanjuje količinu HIV-a u krvi i održava je niskom.
English: For more information about treatment with Ziagen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Ziagen pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
English: The most common side effects with Ziagen (seen in between 1 and 10 patients in 100) are loss of appetite, headache, nausea (feeling sick), vomiting, diarrhoea, rash, fever, lethargy (lack of energy) and tiredness.
Croatian: Najčešće nuspojave lijeka Ziagen (zabilježene u 1 do 10 bolesnika na 100) su gubitak apetita, glavobolja, mučnina (osjećaj slabosti), povraćanje, proljev, osip, vrućica, letargija (manjak energije) i umor.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ziagen.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Ziagen.
English: Based on its review of the quality, safety and effectiveness of the medicine, the Committee decided that Ziagen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Na temelju pregleda kvalitete, sigurne primjene i djelotvornosti lijeka, Odbor je zaključio da koristi od lijeka Ziagen nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Patients with this gene are at an increased risk of having an allergic reaction to abacavir, so they should not take Ziagen.
Croatian: Bolesnici s ovim genom izloženi su povećanom riziku od alergijske reakcije na abakavir pa ne bi smjeli uzimati lijek Ziagen.
English: Ziagen has also been studied in three main studies including 489 HIV-infected patients aged between three months and 18 years.
Croatian: Ziagen je također ispitivan u tri glavna ispitivanja kojima je obuhvaćeno 489 bolesnika zaraženih HIVom u dobi između tri mjeseca i 18 godina.
English: What is Ziagen?
Croatian: Što je Ziagen?
English: Ziagen is used in combination with other antiviral medicines to treat patients who are infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Ziagen se koristi u kombinaciji s drugim antiviroticima za liječenje bolesnika zaraženih virusom humane imunodeficijencije tipa (HIV), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: Why has Ziagen been approved?
Croatian: Zašto je Ziagen odobren?
English: Patients receiving Ziagen also had increases in their CD4 cell counts.
Croatian: U bolesnika koji su primali Ziagen također je zabilježeno povećanje broja CD4 stanica.
English: Ziagen has been studied in six main studies including 1,843 HIV-infected adults (aged 18 years and over).
Croatian: Ziagen je ispitan u šest glavnih ispitivanja kojima je obuhvaćeno 1.843 odraslih osoba zaraženih HIVom (u dobi od 18 godina ili starijih).
English: The active substance in Ziagen, abacavir, is a nucleoside reverse transcriptase inhibitor (NRTI).
Croatian: Djelatna tvar lijeka Ziagen, abakavir, jest nenukleozidni inhibitor povratne transkriptaze (NNRTI).
English: Patients who take Ziagen will also receive an alert card summarising the key safety information on hypersensitivity with the medicine.
Croatian: Bolesnici koji uzimaju Ziagen također će primiti karticu upozorenja koja sadrži sažetak ključnih informacija za sigurnu primjenu vezanih uz preosjetljivost na ovaj lijek.
English: What is the risk associated with Ziagen?
Croatian: Koji su rizici povezani s lijekom Ziagen?
English: Ziagen should be prescribed by a doctor who has experience in the management of HIV infection.
Croatian: Terapiju lijekom Ziagen mora propisati liječnik s iskustvom u liječenju infekcije HIV-om.
English: Ziagen is a medicine that contains the active substance abacavir.
Croatian: Ziagen je lijek koji sadrži djelatnu tvar abakavir.
English: One study compared the effects of Ziagen taken once and twice a day, in combination with lamivudine and efavirenz (other antiviral medicines) in 784 patients.
Croatian: U jednom se ispitivanju usporedilo djelovanje lijeka Ziagen koji se uzimao dvaput na dan u kombinaciji s lamvudinom i efavirenzom (drugim antiviroticima) u 784 bolesnika.
English: In all of the studies, Ziagen caused a decrease in viral loads, particularly when taken with other antiviral medicines.
Croatian: Ziagen je uzrokovao smanjenje virusnog opterećenja, posebice ako se uzimao s drugim antiviroticima.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ziagen, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Ziagen nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Ziagen's effects were compared with other antiviral medicines, placebo (a dummy treatment) or no treatment.
Croatian: Djelovanje Ziagena uspoređeno je s drugim antiviroticima, placebom (prividnim liječenjem) ili bez liječenja.
English: What is Ziagen used for?
Croatian: Za što se Ziagen koristi?
English: Ziagen was taken alone, or added to the combination of lamivudine and zidovudine (other antiviral medicines) or the patients' existing HIV treatment.
Croatian: Ziagen je uziman kao monoterapija ili u kombinaciji s lamivudinom i zidovudinom (drugim antivirotikom) ili s postojećom terapijom protiv HIV-a.
English: For the full list of all side effects and restrictions with Ziagen, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Ziagen potražite u uputi o lijeku.
English: Once- and twice-daily Ziagen had similar effects on viral load.
Croatian: Primjena lijeka Ziagen jednom na dan ili dvaput na dan imala je slično djelovanje na virusno opterećenje.
English: What benefit has Ziagen shown during the studies?
Croatian: Koje su koristi lijeka Ziagen utvrđene u ispitivanjima?
English: How is Ziagen used?
Croatian: Kako se Ziagen koristi?
English: How does Ziagen work?
Croatian: Kako djeluje Ziagen?
English: How has Ziagen been studied?
Croatian: Kako je Ziagen ispitivan?
English: Cmax occurs approximately 30 to 60 minutes after
Croatian: Cmax postiže se otprilike 30 do 60 minuta nakon doziranja.
English: Merckle GmbH Ludwig-Merckle-Strasse 3 89143 Blaubeuren Germany
Croatian: Merckle GmbH Ludwig-Merckle-Straße 3 89143 Blaubeuren
English: • If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in
Croatian: • ako ste alergični na klopidogrel ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: In addition, clinical tolerance was good in
Croatian: Osim toga, klinička podnošljivost bila je dobra u svih bolesnika.
English: Some other medicines may influence the use of Clopidogrel ratiopharm or vice versa.
Croatian: Neki lijekovi mogu utjecati na djelovanje lijeka Klopidogrel ratiopharm i obratno.
English: Since the CAPRIE trial was not powered to evaluate efficacy of individual subgroups, it is not clear whether the differences in relative risk reduction across qualifying conditions are real, or a result of
Croatian: Kako kliničko ispitivanje CAPRIE nije za cilj imalo procijeniti djelotvornost u pojedinačnim podskupinama, nije jasno jesu li razlike relativnog smanjenja rizika unutar podskupina stvarne ili su slučajan rezultat.
English: Contents of the pack and other information What Clopidogrel ratiopharm contains
Croatian: Sadržaj pakiranja i druge informacije Što Klopidogrel ratiopharm sadrži
English: Their frequency is defined using the following conventions: common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: <1/100); rijetke (≥1/10 000, <1/1000); vrlo rijetke (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: For any information about this medicine, please contact the local representative of the Marketing
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka promet:
English: What Clopidogrel ratiopharm is and what it is used for What you need to know before you take Clopidogrel ratiopharm
Croatian: Što je Klopidogrel ratiopharm i za što se koristi Što morate znati prije nego počnete uzimati Klopidogrel ratiopharm
English: Clopidogrel should not be used in children because of efficacy concerns (see section 5.1).
Croatian: Klopidogrel se ne smije primjenjivati u djece zbog razloga djelotvornosti (vidjeti dio 5.1).
English: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Warnings and precautions').
Croatian: Ukoliko ste ipak zabrinuti zbog krvarenja, odmah obavijestite svog liječnika (pogledajte dio 2 „Upozorenja i mjere opreza“).
English: * Information related to clopidogrel with frequency “not known”
Croatian: * Podaci se odnose na klopidogrel s učestalosti „nepoznato“.
English: You should take Clopidogrel ratiopharm for as long as your doctor continues to prescribe it.
Croatian: Klopidogrel ratiopharm trebate uzimati onoliko dugo koliko Vam ga liječnik propisuje.
English: What you need to know before you take Clopidogrel ratiopharm
Croatian: Što morate znati prije nego počnete uzimati Klopidogrel ratiopharm
English: The binding is non-saturable in vitro over a wide concentration
Croatian: Vezanje nije zasićeno in vitro u širokom rasponu koncentracija.
English: Apart from the specific medicinal products interaction information described above, interaction studies with clopidogrel and some medicinal products commonly administered in patients with atherothrombotic disease have not been performed.
Croatian: Osim prethodno opisanih interakcija sa specifičnim lijekovima, nisu provedena ispitivanja interakcija klopidogrela s nekim lijekovima koji se obično propisuju bolesnicima s aterotrombotskom bolesti.
English: In view of the lack of data, clopidogrel cannot be recommended during the first 7 days after acute
Croatian: S obzirom da nema podataka, klopidogrel se ne preporučuje tijekom prvih 7 dana nakon akutnog ishemijskog moždanog udara.
English: • You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects').
Croatian: • Također, odmah obavijestite svog liječnika ako se pojavi medicinsko stanje (koje se naziva trombotična trombocitopenična purpura ili TTP) sa simptomima koji uključuju vrućicu i potkožne modrice koji se mogu pojaviti kao crvene točkice, sa ili bez neobjašnjivog teškog umora, zbunjenosti i žute boje kože ili očiju (žutica) (pogledajte dio 4. „Moguće nuspojave“).
English: Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, boci ili blisteru iza oznake „EXP“.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V . Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.
English: Heparin: in a clinical study conducted in healthy subjects, clopidogrel did not necessitate modification of the heparin dose or alter the effect of heparin on coagulation.
Croatian: Heparin: u jednoj kliničkoj studiji provedenoj na zdravim ispitanicima, primjena klopidogrela nije zahtjevala promjenu doze heparina, niti je mijenjala učinak heparina na koagulaciju.
English: What Clopidogrel ratiopharm is and what it is used for
Croatian: Što je Klopidogrel ratiopharm i za što ste koristi
English: In a relative bioavailability study in adults, the constituted solution of clopidogrel showed a similar extent and slightly higher rate of absorption of the main circulating (inactive) metabolite compared to the
Croatian: U relativnoj studiji bioraspoloživosti lijeka u odraslih, konstituirana otopina klopidogrela pokazala je sličan raspon i neznatno veću brzinu apsorpcije glavnog cirkulirajućeg (neaktivnog) metabolita, u usporedbi s tabletom.
English: As a precautionary measure, breast-feeding should not be continued during treatment with clopidogrel.
Croatian: Kao mjera opreza, treba prestati s dojenjem za vrijeme liječenja lijekom
English: Clopidogrel ratiopharm contains the active ingredient Clopidogrel which belongs to a group of medicines called antiplatelet medicinal products.
Croatian: Klopidogrel ratiopharm sadrži klopidogrel i pripada skupini lijekova koji se nazivaju antitrombocitni lijekovi.
English: Clopidogrel ratiopharm is unlikely to affect your ability to drive or to use machines.
Croatian: Klopidogrel ratiopharm ne bi trebao utjecati na Vašu sposobnost upravljanja vozilima ili strojevima.
English: Platelets (so-called thrombocytes) are very small structures, which clump together during blood clotting.
Croatian: Trombociti su vrlo mala krvna tjelešca, tzv. krvne pločice, koje se nakupljaju tijekom zgrušavanja krvi.
English: While you are taking Clopidogrel ratiopharm:
Croatian: Dok uzimate Klopidogrel ratiopharm:
English: Clopidogrel ratiopharm is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Croatian: Klopidogrel ratiopharm uzimaju odrasli za sprječavanje stvaranja krvnih ugrušaka (tromba) u otvrdnutim krvnim žilama (arterijama), a taj poremećaj zove se aterotromboza i može dovesti do aterotrombotičkih događaja (kao što su moždani udar, srčani udar ili smrt).
English: Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); swelling in the mouth; blisters of the skin; skin allergy; sore mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain;
Croatian: žutica; jaka bol u trbuhu s ili bez bolova u leđima; vrućica, teškoće pri disanju, ponekad povezane s kašljem; generalizirane alergijske reakcije (primjerice, sveukupni osjećaj vrućine s iznenadnom općom nelagodom do nesvjestice); oticanje u ustima; mjehurići na koži; kožne alergijske reakcije; upala u usnoj šupljini (stomatitis); pad krvnoga tlaka; zbunjenost; halucinacije; bol u zglobovima; bol u mišićima; poremećaj okusa ili gubitak osjeta okusa hrane.
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included 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: Zahtjevi za podnošenje PSUR-eva za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Mean peak plasma levels of unchanged clopidogrel (approximately 2.2 - 2.5 ng/ml after a single 75 mg oral dose) occurred approximately 45 minutes after dosing.
Croatian: Srednje vršne razine nepromijenjenog klopidogrela u plazmi (oko 2,2 - 2,5 ng/ml nakon jednokratne oralne doze od 75 mg), postižu se otprilike 45 minuta nakon uzimanja lijeka.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
English: If you are breastfeeding or planning to breastfeed, talk to your doctor before taking this medicine.
Croatian: Ako dojite ili planirate dojiti, obratite se svom liječniku prije uzimanja ovog lijeka.
English: If you forget to take Clopidogrel ratiopharm
Croatian: Ako ste zaboravili uzeti Klopidogrel ratiopharm
English: Although the administration of clopidogrel 75 mg/day did not modify the pharmacokinetics of S-warfarin or International Normalised Ratio (INR) in patients receiving long-term warfarin therapy, coadministration of clopidogrel with warfarin increases the risk of bleeding because of independent
Croatian: Iako primjena klopidogrela u dozi od 75 mg na dan nije utjecala na farmakokinetiku S-varfarina ili INR (International Normalised Ratio) u bolesnika koji primaju dugotrajnu terapiju varfarinom, istodobna primjena klopidogrela s varfarinom povećava rizik od krvarenja zbog nezavisnih učinaka na hemostazu.
English: In CURE, CLARITY, ACTIVE-A and one of the cohort studies (Trenk), no increased event rate was
Croatian: U studijama CURE, CLARITY, ACTIVE-A i jednoj od kohortnih studija (Trenk), nije uočena povećana stopa događaja temeljena na metabolizatorskom statusu.
English: In addition, IPA was 32% (24 hours) and 61% (Day 5), which were greater than in the poor metabolisers receiving the 300 mg/75 mg regimen, and were similar to the other CYP2C19 metaboliser groups receiving the 300 mg/75 mg regimen.
Croatian: vrijednost IPA iznosila je 32% (24 sata) i 61% (dan 5), što je više nego u slabih metabolizatora koji su primali doze od 300 mg/75 mg i slično je ostalim skupinama CYP2C19 metabolizatora koje su primale doze od 300 mg/75 mg.