FrancophonIA/ELRC3.0 huggingface dataset:
English: Combination with with sulpho with with insulin therapy metformin nylurea metformin and sulphonylurea
Croatian: Kombinacija s metforminom sa sulfonilurejom s metforminom i sulfonilurejom s inzulinom
English: Pioglitazone Accord 15 mg tablets: 3 years Pioglitazone Accord 30 mg/ 45 mg tablets: 4 years
Croatian: Pioglitazone Accord 15 mg tablete: 3 godine Pioglitazone Accord 30 mg/ 45 mg tablete: 4 godine
English: Marketing Authorisation Holder: Accord Healthcare S.L.U.
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet Accord Healthcare S.L.U.
English: The effect of pioglitazone (45 mg monotherapy vs. placebo) was studied in a small 18-week trial in type 2 diabetics.
Croatian: Učinak pioglitazona (monoterapija dozom od 45 mg naspram placeba) ispitivao se u malom ispitivanju u trajanju od 18 tjedana u bolesnika sa šećernom bolešću tipa
English: NAME OF THE MARKETING AUTHORISATION HOLDER Accord (Logo)
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Accord (Logo) ROK VALJANOSTI
English: Conditions or restrictions with regard to the safe and effective use of the medicinal product
Croatian: Uvjeti ili ograničenja vezani uz sigurnu i učinkovitu primjenu lijeka
English: common (may affect up to 1 in 10 people) - respiratory infection - abnormal vision - weight gain - numbness uncommon (may affect up to 1 in 100 people) - inflammation of the sinuses (sinusitis) - difficulty sleeping (insomnia)
Croatian: često (mogu se pojaviti u od 1 do 10 na 100 osoba) - infekcija dišnih puteva - poremećen vid - povećanje tjelesne težine - utrnulost manje često (mogu se pojaviti u od 1 do 10 na 1000 osoba) - upala sinusa (sinusitis) - poteškoće sa spavanjem (nesanica)
English: What Pioglitazone Accord contains
Croatian: Što Pioglitazone Accord sadrži
English: Broken bones have been reported commonly (may affect up to 1 in 10 people) in female patients taking Pioglitazone Accord and have also been reported in male patients (frequency cannot be estimated from the available data) taking Pioglitazone Accord.
Croatian: Prijelomi kostiju često (može se pojaviti u od 1 do 10 na 100 osoba) su zabilježeni u žena koje su uzimale Pioglitazone Accord, kao i u muškaraca (učestalost nije moguće utvrditi iz dostupnih podataka) koji su uzimali Pioglitazone Accord.
English: Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Pioglitazone Accord and insulin experienced the development of heart failure.
Croatian: U nekih bolesnika koji su dugo imali šećernu bolest tipa 2 i srčanu bolest ili su preboljeli moždani udar, a liječili su se lijekom Pioglitazone Accord i inzulinom došlo je do zatajenja srca.
English: If you stop taking Pioglitazone Accord
Croatian: Ako prestanete uzimati Pioglitazone Accord
English: If you forget to take Pioglitazone Accord
Croatian: Ako ste zaboravili uzeti Pioglitazone Accord
English: METHOD AND ROUTE (S) OF ADMINISTRATION
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA
English: Each tablet contains 111.70 mg of lactose monohydrate (see section 4.4).
Croatian: Jedna tableta sadrži 111,70 mg laktoze hidrata (vidjeti dio 4.4).
English: How to take Pioglitazone Accord
Croatian: Kako uzimati Pioglitazone Accord
English: • The other ingredients are lactose monohydrate, carmellose calcium, hydroxypropyl cellulose (E
Croatian: • Ostali sastojci su laktoza hidrat, karmelozakalcij, hidroksipropilceluloza (E 465) i magnezijev stearat (E 572).
English: Each tablet contains 37.24 mg of lactose monohydrate (see section 4.4).
Croatian: Jedna tableta sadrži 37,24 mg laktoze hidrata (vidjeti dio 4.4).
English: Each tablet contains 74.46 mg of lactose monohydrate (see section 4.4).
Croatian: Jedna tableta sadrži 74,46 mg laktoze hidrata (vidjeti dio 4.4).
English: Pioglitazone Accord 15 mg tablets Pioglitazone Accord 30 mg tablets Pioglitazone Accord 45 mg tablets
Croatian: Pioglitazone Accord 15 mg tablete Pioglitazone Accord 30 mg tablete Pioglitazone Accord 45 mg tablete
English: Heart failure has been reported with marketing use of pioglitazone, and more frequently when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.
Croatian: Zatajenje srca uz primjenu pioglitazona zabilježeno je nakon stavljanja lijeka u promet i bilo je češće kad se pioglitazon primjenjivao u kombinaciji s inzulinom ili u bolesnika sa zatajenjem srca u anamnezi.
English: Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking Pioglitazone Accord.
Croatian: Karcinom mokraćnog mjehura manje je često (može se pojaviti u od 1 do 10 na 1000 osoba) nastao u bolesnika koji uzimaju Pioglitazone Accord.
English: How to store Pioglitazone Accord
Croatian: Kako čuvati Pioglitazone Accord
English: There may be an increased possibility of becoming pregnant because you may ovulate again when you take Pioglitazone Accord.
Croatian: Kad uzimate Pioglitazone Accord, možete ponovno imati ovulaciju pa mogućnost trudnoće može biti povećana.
English: Infections and infestations upper respiratory tract infection common common common common common bronchitis common sinusitis uncommon uncommon uncommon uncommon uncommon
Croatian: Infekcije i infestacije Infekcije gornjih dišnih puteva bronhitis sinusitis manje često manje često manje često manje često manje često
English: Your doctor may increase the dose to a maximum of 45 mg once a day.
Croatian: Vaš liječnik može povećati dozu na najviše 45 mg jedanput dnevno. liječnik će Vam reći koju dozu trebate uzimati.
English: as monotherapy - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is in appropriate because of contraindications or intolerance as dual oral therapy in combination with - metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin
Croatian: kao dvojna peroralna terapija u kombinaciji s - metforminom, u odraslih bolesnika (osobito bolesnika s prekomjernom tjelesnom težinom) s nedostatnom kontrolom glikemije usprkos monoterapiji metforminom u najvećoj podnošljivoj dozi - sulfonilurejom, samo u odraslih bolesnika s nepodnošenjem metformina ili u kojih je metformin kontraindiciran, s nedostatnom kontrolom glikemije usprkos monoterapiji sulfonilurejom u najvećoj podnošljivoj dozi.
English: Pioglitazone Accord contains lactose monohydrate If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Pioglitazone Accord.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije nego što uzmete Pioglitazone Accord.
English: common (may affect up to 1 in 10 people) - headache - dizziness - joint pain - impotence - back pain - shortness of breath - small reduction in red blood cell count - flatulence uncommon (may affect up to 1 in 100 people) - sugar in urine, proteins in urine - increase in enzymes - spinning sensation (vertigo) - sweating - tiredness
Croatian: često (mogu se pojaviti u do 1 na 10 osoba) - glavobolja - omaglica - bol u zglobovima - impotencija - križobolja - nedostatak zraka - malo sniženje broja crvenih krvnih stanica - nadutost manje često (mogu se pojaviti u od 1 do 10 na 1000 osoba)
English: • if you have blood in your urine that your doctor has not checked.
Croatian: ako imate ili ste imali karcinom mokraćnog mjehura. ako imate krv u mokraći, a niste proveli odgovarajuće pretrage.
English: You can usually continue to take other medicines whilst you are being treated with Pioglitazone Accord.
Croatian: Za vrijeme liječenja lijekom Pioglitazone Accord obično možete nastaviti uzimati druge lijekove.
English: • Each Pioglitazone Accord 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride).
Croatian: • Jedna Pioglitazone Accord 30 mg tableta sadrži 30 mg pioglitazona (u obliku klorida).
English: Blurred vision due to swelling (or fluid) at the back of the eye (frequency cannot be estimated from the available data) has also been reported in patients taking Pioglitazone Accord.
Croatian: U bolesnika koji uzimaju Pioglitazone Accord zabilježen je i zamagljen vid zbog oticanja (ili tekućine) stražnje strane oka (učestalost se ne može procijeniti iz dostupnih podataka).
English: EU/1/11/722/001-010 (14/28/30/50/56/84/90/98/112/196 tablets in alu/alu blister) EU/1/11/722/011-020 (14/28/30/50/56/84/90/98/112/196 tablets in alu/alu blister) EU/1/11/722/021-030 (14/28/30/50/56/84/90/98/112/196 tablets in alu/alu blister)
Croatian: EU/1/11/722/001-010 (14/28/30/50/56/84/90/98/112/196 tableta u Al/Al blisterima) EU/1/11/722/011-020 (14/28/30/50/56/84/90/98/112/196 tableta u Al/Al blisterima) EU/1/11/722/021-030 (14/28/30/50/56/84/90/98/112/196 tableta u Al/Al blisterima)
English: Your doctor will ask you to have blood tests periodically during treatment with Pioglitazone Accord.
Croatian: Liječnik će tražiti da za vrijeme liječenja lijekom Pioglitazone Accord povremeno napravite krvne pretrage, da bi se provjerilo radi li Vaša jetra normalno.
English: • Each Pioglitazone Accord 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride).
Croatian: • Jedna Pioglitazone Accord 45 mg tableta sadrži 45 mg pioglitazona (u obliku klorida).
English: Adverse reaction Frequency of adverse reactions of pioglitazone by treatment regimen
Croatian: Učestalost nuspojava pioglitazona prema režimu liječenja Monoterapija
English: Allergic reactions have been reported (frequency cannot be estimated from the available data) in patients taking Pioglitazone Accord.
Croatian: Kod bolesnika koji su uzimali Pioglitazone Accord prijavljene su alergijske reakcije (učestalost se ne može procijeniti iz dostupnih podataka).
English: MARKETING AUTHORISATION HOLDER
Croatian: Nositelj odobrenja će podnijeti dopunjeni
English: • Pioglitazone Accord 45 mg tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO' on one side and ‘45' on the other side.
Croatian: • Pioglitazone Accord 45 mg tablete su bijele do gotovo bijele boje, plosnate, okrugle tablete bez ovojnice sa zaobljenim rubovima i utisnutom oznakom ‘PIO' s jedne strane i ‘45' s druge strane.
English: After excluding patients in whom exposure to study drug was less than one year at the time of diagnosis of bladder cancer, there were 7 cases (0.06%) on pioglitazone and 2 cases (0.02%) in control groups.
Croatian: Nakon isključenja bolesnika koji su u vrijeme dijagnoze karcinoma mokraćnog mjehura bili izloženi ispitivanom lijeku kraće od godinu dana, u skupinama koje su primale pioglitazon bilo je 7
English: Pioglitazone Accord 30 mg tablets
Croatian: Pioglitazone Accord 30 mg tablete
English: Pioglitazone Accord 45 mg tablets
Croatian: Pioglitazone Accord 45 mg tablete
English: See the package leaflet for further information.
Croatian: Za dodatne informacije vidjeti Uputu o lijeku.
English: • Pioglitazone Accord 30 mg tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO' on one side and ‘30' on the other side.
Croatian: • Pioglitazone Accord 30 mg tablete su bijele do gotovo bijele boje, okrugle, plosnate tablete bez ovojnice sa zaobljenim rubovima i utisnutom oznakom ‘PIO' s jedne strane i ‘30' s druge strane.
English: Localised swelling (oedema) has also been experienced very commonly (may affect more than 1 in 10 people) in patients taking Pioglitazone Accord in combination with insulin.
Croatian: Lokalizirano oteknuće (edemi) također su vrlo često nastajali u bolesnika koji su uzimali Pioglitazone Accord u kombinaciji s inzulinom.
English: • Each Pioglitazone Accord 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride).
Croatian: • Jedna Pioglitazone Accord 15 mg tableta sadrži 15 mg pioglitazona (u obliku klorida).
English: • Pioglitazone Accord 15 mg tablets are white to off white, round, biconvex, uncoated tablets debossed with ‘P' on one side and ‘15' on other side.
Croatian: • Pioglitazone Accord 15 mg tablete su bijele do gotovo bijele boje, okrugle, bikonveksne, bez ovojnice i s utisnutom oznakom ‘P' s jedne strane i ‘15' s druge strane.
English: The tablets are white to off white, round, biconvex, uncoated tablets debossed with ‘P' on one side and ‘15' on other side.
Croatian: Tablete su bijele do gotovo bijele, okrugle, bikonveksne, bez ovojnice s utisnutom oznakom ‘P' s jedne strane i ‘15' s druge strane.
English: Each tablet contains 45 mg of pioglitazone (as hydrochloride).
Croatian: Jedna tableta sadrži 45 mg pioglitazona (u obliku klorida).
English: Pioglitazone Accord 15 mg tablets
Croatian: Pioglitazone Accord 15 mg tablete
English: Each tablet contains 30 mg of pioglitazone (as hydrochloride).
Croatian: Jedna tableta sadrži 30 mg pioglitazona (u obliku klorida).
English: Pioglitazone Accord 15 mg tablets Pioglitazone
Croatian: Pioglitazone Accord 15 mg tablete pioglitazon
English: The tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO' on one side and ‘45' on the other side.
Croatian: Tablete su bijele do gotovo bijele boje, plosnate, okrugle, bez ovojnice sa zaobljenim rubovima i utisnutom oznakom ‘PIO' s jedne strane i ‘45' s druge strane.
English: Pioglitazone Accord 30 mg tablets Pioglitazone
Croatian: Pioglitazone Accord 30 mg tablete pioglitazon
English: Each tablet contains 15 mg of pioglitazone (as hydrochloride).
Croatian: Jedna tableta sadrži 15 mg pioglitazona (u obliku klorida).
English: EU/1/11/722/021 14 tablets EU/1/11/722/022 28 tablets EU/1/11/722/023 30 tablets EU/1/11/722/024 50 tablets EU/1/11/722/025 56 tablets EU/1/11/722/026 84 tablets EU/1/11/722/027 90 tablets EU/1/11/722/028 98 tablets EU/1/11/722/029 112 tablets EU/1/11/722/030 196 tablets
Croatian: EU/1/11/722/021 14 tableta EU/1/11/722/022 28 tableta EU/1/11/722/023 30 tableta EU/1/11/722/024 50 tableta EU/1/11/722/025 56 tableta EU/1/11/722/026 84 tableta EU/1/11/722/027 90 tableta EU/1/11/722/028 98 tableta EU/1/11/722/029 112 tableta EU/1/11/722/030 196 tableta
English: EU/1/11/722/001 14 tablets EU/1/11/722/002 28 tablets EU/1/11/722/003 30 tablets EU/1/11/722/004 50 tablets EU/1/11/722/005 56 tablets EU/1/11/722/006 84 tablets EU/1/11/722/007 90 tablets EU/1/11/722/008 98 tablets EU/1/11/722/009 112 tablets EU/1/11/722/010 196 tablets
Croatian: EU/1/11/722/001 14 tableta EU/1/11/722/002 28 tableta EU/1/11/722/003 30 tableta EU/1/11/722/004 50 tableta EU/1/11/722/005 56 tableta EU/1/11/722/006 84 tableta EU/1/11/722/007 90 tableta EU/1/11/722/008 98 tableta EU/1/11/722/009 112 tableta EU/1/11/722/010 196 tableta
English: The tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO' on one side and ‘30' on the other side.
Croatian: Tablete su bijele do gotovo bijele boje, plosnate, okrugle, bez ovojnice sa zaobljenim rubovima i utisnutom oznakom ‘PIO' s jedne strane i ‘30' s druge strane.
English: EU/1/11/722/011 14 tablets EU/1/11/722/012 28 tablets EU/1/11/722/013 30 tablets EU/1/11/722/014 50 tablets EU/1/11/722/015 56 tablets EU/1/11/722/016 84 tablets EU/1/11/722/017 90 tablets EU/1/11/722/018 98 tablets EU/1/11/722/019 112 tablets EU/1/11/722/020 196 tablets
Croatian: EU/1/11/722/011 14 tableta EU/1/11/722/012 28 tableta EU/1/11/722/013 30 tableta EU/1/11/722/014 50 tableta EU/1/11/722/015 56 tableta EU/1/11/722/016 84 tableta EU/1/11/722/017 90 tableta EU/1/11/722/018 98 tableta EU/1/11/722/019 112 tableta EU/1/11/722/020 196 tableta
English: Pioglitazone Accord 45 mg tablets Pioglitazone
Croatian: Pioglitazone Accord 45 mg tablete pioglitazon
English: Breast-feeding
Croatian: PSUR-evi
English: Do not take Pioglitazone Accord: • if you are allergic to pioglitazone or any of the other ingredients of this medicine (listed in Section
Croatian: Nemojte uzimati Pioglitazone Accord: ako ste preosjetljivi (alergični) na pioglitazon ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). ako imate zatajenje srca ili ste prije imali zatajenje srca. ako imate bolest jetre. ako imate dijabetičku ketoacidozu (komplikacija šećerne bolesti koja uzrokuje nagli gubitak na tjelesnoj težini, mučninu i povraćanje).
English: NAME OF THE MEDICINAL PRODUCT Pioglitazone Accord 45 mg tablets
Croatian: NAZIV LIJEKA Pioglitazone Accord 45 mg tablete pioglitazon IME NOSITELJA
English: NAME OF THE MEDICINAL PRODUCT Pioglitazone Accord 15 mg tablets
Croatian: NAZIV LIJEKA Pioglitazone Accord 15 mg tablete pioglitazon IME NOSITELJA
English: NAME OF THE MEDICINAL PRODUCT Pioglitazone Accord 30 mg tablets
Croatian: NAZIV LIJEKA Pioglitazone Accord 30 mg tablete pioglitazon IME NOSITELJA
English: Best Response
Croatian: Najbolji odgovor
English: Estimates based on other analysis
Croatian: Procjene temeljene na drugoj analizi
English: Concentrate (ml)*
Croatian: Koncentrat (ml)*
English: The infusion will be given over 2 hours.
Croatian: Infuzija će trajati 2 sata.
English: Talk to your doctor about contraception.
Croatian: Razgovarajte s liječnikom o kontracepciji.
English: Patients who met each of the following criteria:
Croatian: Bolesnici koji zadovoljavaju sve sljedeće kriterije:
English: If you (or your child) weigh less than 20 kg, the infusion time may be longer.
Croatian: Vi (ili Vaše dijete) težite manje od 20 kg, vrijeme infuzije može biti i dulje.
English: It is important to drink plenty of water to avoid dehydration.
Croatian: Važno je piti puno vode kako bi se spriječila dehidracija.
English: Your doctor will give you Ivozall once every day for 5 days.
Croatian: Liječnik će Vam lijek Ivozall davati jednom na dan tijekom 5 dana.
English: CR + CRp + PR 18
Croatian: KR + KRt + PR 18
English: Ivozall may harm both male and female reproductive organs.
Croatian: Ivozall može naškoditi i muškim i ženskim reproduktivnim organima.
English: However, there are no known clinically significant interactions with other medicinal products or laboratory tests.
Croatian: Međutim, nema poznatih klinički značajnih interakcija s drugim lijekovima ili laboratorijskim testovima.
English: ITT* patients (n = 61)
Croatian: ITT* bolesnici (n = 61)
English: 5.2 hours
Croatian: 5,2 sati
English: Your doctor will tell you when you need to be given this medicine.
Croatian: Liječnik će Vam reći kada morate primiti lijek.
English: Because of the way this medicine works, it will affect your blood and other organs.
Croatian: Zbog svog načina djelovanja ovaj lijek utječe na krv i druge organe.
English: PR = Partial remission
Croatian: PR = parcijalna remisija
English: > 24 hours
Croatian: > 24 sata
English: Estimates based on noncompartmental analysis (n = 14 / n = 14)
Croatian: Procjene temeljene na nekompartmentalnoj analizi (n = 14 / n = 14)
English: The excretion of clofarabine in milk has not been studied in animals.
Croatian: Izlučivanje klofarabina u mlijeko nije istraženo na životinjama.
English: It works best against cells which are multiplying quickly - such as cancer cells.
Croatian: Najbolje djeluje protiv stanica koje se brzo dijele - poput stanica raka.
English: Its antitumour activity is believed to be due to 3 mechanisms:
Croatian: Vjeruje se da njegovo protutumorsko djelovanje počiva na 3 mehanizma:
English: The reference medicine for Ivozall has been authorised under ‘exceptional circumstances'.
Croatian: Referentni lijek za Ivozall odobren je u „iznimnim okolnostima”.
English: (There are no exposure data in rabbits.)
Croatian: (Nema podataka o izloženosti u kunića.)
English: Children weighing < 20 kg
Croatian: Djeca tjelesne težine < 20 kg
English: Haematuria was observed in 13% of patients overall.
Croatian: Hematurija je primijećena u ukupno 13% bolesnika.
English: Clinical efficacy and safety
Croatian: Klinička djelotvornost i sigurnost:
English: Ivozall contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU.
Croatian: Ivozall sadrži istu djelatnu tvar i djeluje na isti način kao „referentni lijek” koji je već odobren u
English: Body surface area must be calculated using the actual height and weight of the patient before the start of each cycle.
Croatian: Površina tijela izračunava se na temelju stvarne visine i težine bolesnika prije početka svakog ciklusa.
English: See section 2 “Ivozall contains sodium”.
Croatian: Vidjeti dio 2. „Ivozall sadrži natrij“.
English: It works by hindering the growth of abnormal white blood cells, and eventually kills them.
Croatian: Djeluje tako da onemogućuje rast poremećenih bijelih krvnih stanica i naposljetku ih ubija.
English: • Respiratory status, blood pressure, fluid balance and weight throughout and immediately after the 5 day clofarabine administration period.
Croatian: • respiratorni status, krvni tlak, ravnotežu tekućina i tjelesnu težinu tijekom i odmah nakon petodnevnog razdoblja primjene klofarabina.
English: Other exfoliative conditions have also been reported.
Croatian: Također su prijavljena su i druga eksfolijativna stanja.
English: Most of the cardiac adverse reactions were reported in the first 2 cycles.
Croatian: Većina srčanih nuspojava prijavljena je tijekom prva 2 ciklusa.
English: Therefore, Ivozall should not be used during pregnancy, especially not during the first trimester, unless clearly necessary (i.e. only if the potential benefit to the mother outweighs the risk to the foetus).
Croatian: Stoga se lijek Ivozall ne smije primjenjivati tijekom trudnoće, naročito tijekom prvog tromjesečja, osim ako to nije neophodno (tj. ako potencijalna korist za majku nadilazi rizik za plod).
English: Individual duration remission and survival data for patients who achieved CR or CRp
Croatian: Pojedinačno trajanje remisije i podaci o preživljenju za bolesnike koji su postigli KR ili KRt
English: Men must also use effective contraception while they or their partner are treated with clofarabine.
Croatian: Muškarci također moraju primjenjivati učinkovitu kontracepciju dok se oni ili njihove partnerice liječe klofarabinom.
English: Non-infectious events
Croatian: Neinfektivni događaji
English: Your doctor will monitor your health and may change your dose depending on your response to the treatment.
Croatian: Liječnik će nadzirati Vaše zdravstveno stanje, a možda i mijenjati dozu u skladu s odgovorom na liječenje.
English: If you are pregnant or you become pregnant during treatment with clofarabine, get medical advice immediately.
Croatian: Ako ste trudni ili zatrudnite tijekom liječenja klofarabinom, odmah potražite savjet liječnika.
English: Grade 3 or 4 elevated creatinine occurred in 8% of patients.
Croatian: Povišenje kreatinina 3. ili 4. stupnja javilo se u 8% bolesnika.
English: Children and adolescents (≥ 1 year old)
Croatian: Djeca i adolescenti (u dobi ≥ 1 godine)
English: The table below summarises the key efficacy results for this study.
Croatian: Tablica u nastavku sažeto navodi ključne rezultate djelotvornosti iz ovog ispitivanja.
English: Clofarabine was teratogenic in rats and rabbits.
Croatian: Klofarabin je bio teratogen u štakora i kunića.
English: Patients who underwent transplant while in continued remission*
Croatian: Bolesnici koji su transplantirani dok su bili u kontinuiranoj remisiji*
English: This has occurred more frequently within 30 days of treatment, and in the setting of combination chemotherapy.
Croatian: To se češće javljalo unutar 30 dana liječenja i to kada se lijek primjenjivao u kombiniranoj kemoterapiji.
English: Children < 1 year old
Croatian: Djeca u dobi < 1 godine
English: Elderly (≥ 65 years old)
Croatian: Starije osobe(u dobi od ≥ 65 godina)
English: Overall remission (CR + CRp)
Croatian: Ukupna remisija (KR + KRt)
English: As a result, it is not expected to affect the metabolism of active substances which are known substrates for these enzymes.
Croatian: Zbog toga se ne očekuje da bi lijek mogao djelovati na metabolizam djelatnih tvari koje su poznati supstrati tih enzima.
English: • Patients who met all of the criteria for a CR except for recovery of platelet counts to > 100 x 109/l
Croatian: • bolesnici koji zadovoljavaju sve kriterije za KR, osim oporavka broja trombocita do > 100 x 109/l
English: The diluted concentrate should be a clear, colourless solution.
Croatian: Razrijeđen koncentrat mora biti bistra i bezbojna otopina.