FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 5 Incidence of clinically relevant grade 3/4* laboratory abnormalities in ≥ 2% of patients in any disease group from the Phase 2 Trial (N=449): minimum follow-up of 64 month for all ongoing patients Laboratory test
Croatian: ≥2% bolesnika u bilo kojoj skupini bolesti iz ispitivanja faze 2 (N=449):
English: • renal artery stenosis (narrowing of the blood vessels to one or both kidneys)
Croatian: • stenoza bubrežne arterije (suženje krvnih žila koje vode do jednog ili oba bubrega)
English: Age Median, years (range) Gender, n (%) Male Race, n (%) Asian Black/African American White Other ECOG Performance Status, n (%) ECOG=0 or 1 Disease history Median time from diagnosis to first dose, years (range) Resistant to Prior TKI Therapy a *, n (%)
Croatian: Medijan vremena od postavljanja dijagnoze do prve doze, godine (raspon) Rezistentni na prethodnu TKI terapijua *, n(%) Prethodna TKI terapija- broj režima, n (%)
English: In the phase 2 trial (with a minimum of 64 months follow-up), arterial occlusive adverse reactions have occurred in 25% of patients (treatment-emergent frequencies).
Croatian: U ispitivanju faze 2 (s najmanje 64 mjeseca praćenja), nuspojave arterijske okluzije javile su se u 25%
English: Iclusig 15 mg film-coated tablets Iclusig 30 mg film-coated tablets Iclusig 45 mg film-coated tablets ponatinib
Croatian: Iclusig 15 mg filmom obložene tablete Iclusig 30 mg filmom obložene tablete Iclusig 45 mg filmom obložene tablete
English: Uncommon myocardial ischemia, cardiac discomfort, ischemic cardiomyopathy, arteriospasm coronary, left ventricular dysfunction,
Croatian: Manje često ishemija miokarda, srčana nelagoda, ishemijska kardiomiopatija, spazam koronarne arterije, disfunkcija lijeve klijetke,
English: ≥ 12 month reduction at 15 mg 44
Croatian: Bilo koje smanjenje doze na 15 mg 52
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Croatian: Kako čuvati Iclusig Lijek čuvajte izvan pogleda i dohvata djece.
English: The bottle contains one sealed plastic canister containing a molecular sieve desiccant.
Croatian: Boca sadrži jedan plastični zatvoreni spremnik s molekularnim sitom kao sredstvom za sušenje.
English: INFORMATION IN BRAILLE Outer Carton:
Croatian: 16. PODACI NA BRAILLEOVOM PISMU
English: • skin rash, peeling of the skin, abnormal thickening of the skin, redness, bruising, skin pain,
Croatian: • kožni osip, ljuštenje kože, nenormalna zadebljanja kože, crvenilo, nastanak modrica, bol po koži, promjene boje kože, gubitak kose
English: Serious side effects (common: may affect up to 1 in 10 people):
Croatian: Ozbiljne nuspojave (često: mogu se javiti u do 1 na 10 osoba):
English: • increased blood level of bilirubin - the yellow breakdown substance of the blood pigment
Croatian: • povišena razina bilirubina u krvi - žuti razgradni produkt krvnog pigmenta (simptomi uključuju:
English: Iclusig 45 mg
Croatian: Kutija: Iclusig 45 mg
English: The bottle contains one sealed canister containing a molecular sieve desiccant.
Croatian: Boca sadrži jedan zatvoreni spremnik s molekularnim sitom kao sredstvom za sušenje.
English: Uncommon poor peripheral circulation, splenic infarction, embolism venous, venous thrombosis, hypertensive crisis, renal artery stenosis
Croatian: Manje često slaba periferna cirkulacija, infarkt slezene, venska embolija, venska tromboza, hipertenzivna kriza, stenoza bubrežne arterije
English: Common hypothyroidism
Croatian: Često hipotiroidizam
English: For all patients in the phase 2 trial, the dose intensity-safety relationship indicated that there are significant increases in grade ≥ 3 adverse events (cardiac failure, arterial thrombosis, hypertension, thrombocytopenia, pancreatitis, neutropenia, rash, ALT increase, AST increase, lipase increase, myelosuppression, arthralgia) over the dose range of 15 to 45 mg once-daily.
Croatian: Za sve bolesnike u ispitivanju faze 2, odnos jačina doze-sigurnost ukazao je na značajna povećanja štetnih događaja stupnja ≥ 3 (zatajenje srca, arterijska tromboza, hipertenzija, trombocitopenija,
English: Iclusig 30 mg
Croatian: Kutija: Iclusig 30 mg
English: B to become active again, which can be fatal in some cases.
Croatian: To je potrebno jer Iclusig može uzrokovati ponovnu aktivaciju hepatitisa B što u nekim slučajevima može rezultirati smrtnim ishodom.
English: Reducing the dose of Iclusig to 15 mg should be considered for CP-CML patients who have achieved a major cytogenetic response taking the following factors into account in the individual patient assessment: cardiovascular risk, side effects of ponatinib therapy, time to cytogenetic response, and BCR-ABL transcript levels (see sections 4.4 and 5.1).
Croatian: kardiovaskularni rizik, nuspojave liječenja ponatinibom, vrijeme do citogenetičkog odgovora i razine BCR-ABL transkripta (vidjeti dijelove 4.4 i 5.1).
English: In the phase 2 trial, 86 CP-CML patients achieved MCyR at a dose of 45 mg, 45 CP-CML patients achieved MCyR after a dose reduction to 30 mg, mostly for adverse events.
Croatian: U ispitivanju faze 2, 86 bolesnika u kroničnoj fazi KML-a postiglo je MCyR pri dozi od 45 mg , 45
English: • heart attack (symptoms include: sudden feeling of increased heart rate, chest pain, breathlessness)
Croatian: • srčani udar (simptomi uključuju: iznenadan osjećaj povećane brzine srčanih otkucaja, bol u prsnom košu, nedostatak zraka) • promjene koncentracija u krvi:
English: High density polyethylene (HDPE) bottles with screw-top closures, containing either 30, 60 or 180 film-coated tablets, together with one plastic canister containing a molecular sieve desiccant.
Croatian: Boce od polietilena visoke gustoće (HDPE) s navojnim zatvaračima, sadrže 30, 60 ili 180 filmom obloženih tableta i jedan plastični spremnik s molekularnim sitom kao sredstvom za sušenje.
English: The clinical relevance of these findings on human fertility is unknown.
Croatian: Klinički značaj ovih nalaza na ljudsku plodnost nije poznat.
English: Each film-coated tablet contains 80 mg of lactose monohydrate.
Croatian: Svaka filmom obložena tableta sadrži 80 mg laktoze hidrata.
English: A break in treatment or a decrease in dose may be required when lipase is increased.
Croatian: slučaju povišenih vrijednosti serumske lipaze, možda će biti potrebno napraviti stanku u liječenju ili smanjiti dozu.
English: High density polyethylene (HDPE) bottles with screw-top closures, containing either 30 or 90 film-coated tablets, together with one plastic canister containing a molecular sieve desiccant.
Croatian: Boce od polietilena visoke gustoće (HDPE) s navojnim zatvaračima, sadrže 30 ili 90 filmom obloženih tableta i jedan plastični spremnik s molekularnim sitom kao sredstvom za sušenje.
English: In a study in rats, diffuse corneal edema with neutrophilic cell infiltration, and hyperplastic changes in the lenticular epithelium suggestive of a mild phototoxic reaction were observed in animals treated with 5 and 10 mg/kg ponatinib.
Croatian: U studijama na štakorima kod doza od 5 i 10 mg/kg ponatiniba uočeni su difuzni edem rožnice s infiltracijom neutrofilnih stanica i hiperplastične promjene u epitelu leće što ukazuje na blage fototoksične reakcije.
English: High density polyethylene (HDPE) bottles with screw-top closures, containing 30 film-coated tablets, together with one plastic canister containing a molecular sieve desiccant.
Croatian: Boce od polietilena visoke gustoće (HDPE) s navojnim zatvaračima, sadrže 30 filmom obloženih tableta i jedan plastični spremnik s molekularnim sitom kao sredstvom za sušenje.
English: At doses of 30 mg or greater plasma steady state trough concentrations of ponatinib typically exceed 21 ng/mL (40 nM).
Croatian: Pri dozama od 30 mg ili većim u stanju dinamičke ravnoteže koncentracija ponatiniba obično prelazi
English: Ph+ cells) and partial (1% to 35% Ph+ cells) cytogenetic responses.
Croatian: c MCyR kombinira i kompletne (bez uočenih Ph+ stanica) i parcijalne (1% do 35% Ph+ stanica) citogenetičke odgovore.
English: The clinical relevance of this finding for humans is not known.
Croatian: Klinički značaj ovog nalaza za ljude nije poznat.
English: White, biconvex, round film-coated tablet that is approximately 8 mm in diameter, with "C7" debossed on one side.
Croatian: Bijela, bikonveksna okrugla filmom obložena tableta, promjera oko 8 mm s oznakom "C7" utisnutom na jednoj strani.
English: The clinical relevance of these findings to human fertility is unknown.
Croatian: Klinički značaj ovih nalaza za ljudsku plodnost nije poznat.
English: Based on the Kaplan-Meier estimates, 82% (95% CI: [74%-88%]) of CP-CML (median duration of treatment: 32.2 months) patients who achieved a MCyR are projected to maintain that response at 48 months and 61% (95% CI: [51%- 70%]) of CP-CML patients who achieved a MMR are projected to maintain that response at 36 months.
Croatian: 32,2 mjeseci) koji su postigli MCyR održati postignuti odgovor nakon 48 mjeseci i 61% (95% CI: [51% - 70%]) bolesnika u kroničnoj fazi KML-a koji su postigli MMR održati postignuti odgovor nakon 36 mjeseci.
English: Prior TKI therapy- number of regimens, n (%)
Croatian: ECOG funkcionalni status, n (%)
English: • Contraceptive advice for men and women Women of childbearing age being treated with Iclusig should avoid becoming pregnant.
Croatian: Ženama reproduktivne dobi koje se liječe lijekom Iclusig se ne preporučuje trudnoća.
English: • pain in bones, joints, pain in muscles, back, arms or legs, muscle spasms
Croatian: • bolovi u kostima, zglobovima, bol u mišićima, leđima, rukama ili nogama, grčevi mišića • umor, nakupljanje tekućine u rukama i/ili nogama, vrućica, bol
English: Ponatinib is a potent pan BCR-ABL inhibitor with structural elements, including a carbon-carbon triple-bond, that enable high affinity binding to native BCR-ABL and mutant forms of the ABL kinase.
Croatian: Zahvaljujući strukturi koja uključuje i trostruku vezu između atoma ugljika ponatinib ima visoki afinitet vezivanja za divlji tip BCR-ABL i mutirane ABL kinaze.
English: Co-administration of a single 15 mg oral dose of Iclusig in the presence of ketoconazole (400 mg daily), a strong CYP3A inhibitor, resulted in modest increases in ponatinib systemic exposure, with ponatinib AUC0-∞ and Cmax values that were 78% and 47% higher, respectively, than those seen when ponatinib was administered alone.
Croatian: Istovremena peroralna primjena 15 mg lijeka Iclusig s ketokonazolom (400 mg dnevno), snažnim CYP3A inhibitorom uzrokovala je skromni porast u sistemskoj izloženosti ponatinibu s vrijednostima
English: Iclusig 45 mg film-coated tablets
Croatian: Iclusig 45 mg filmom obložene tablete
English: How to store Iclusig
Croatian: Moguće nuspojave Kako čuvati Iclusig
English: Common pulmonary embolism, pleural effusion, epistaxis, dysphonia, pulmonary hypertension
Croatian: Često plućna embolija, pleuralni izljev, epistaksa,
English: White, biconvex, round film-coated tablet that is approximately 9 mm in diameter, with “AP4” debossed on one side.
Croatian: Bijela, bikonveksna okrugla filmom obložena tableta, promjera oko 9 mm s oznakom "AP4" utisnutom na jednoj strani.
English: Common pancytopenia, febrile neutropenia, white blood cell count decreased, lymphocyte count decreased
Croatian: Često pancitopenija, febrilna neutropenija, smanjen broj leukocita, smanjen broj limfocita
English: Iclusig 15 mg
Croatian: Kutija: Iclusig 15 mg
English: Iclusig 30 mg film-coated tablets
Croatian: Iclusig 30 mg filmom obložene tablete
English: • Iclusig should be withheld and resumed at the same dose after recovery to ANC ≥ 1.5 x 109/L and platelet ≥ 75 x 109/L Recurrence at 45 mg:
Croatian: • Potrebno je obustaviti primjenu lijeka Iclusig i nastaviti s istom dozom nakon oporavka ABN na ≥ 1,5 x 109/l te trombocita na ≥ 75 x 109/l
English: • Iclusig should be withheld and resumed at 15 mg after recovery to ANC ≥ 1.5 x 109/L and platelet ≥ 75 x 109/L
Croatian: • Potrebno je obustaviti primjenu lijeka Iclusig i nastaviti s dozom od 15 mg nakon oporavka ABN na ≥ 1,5 x 109/l te trombocita na ≥ 75 x 109/l
English: Cohort (N=65)
Croatian: R/I kohorta (N=65)
English: Iclusig is for oral use.
Croatian: Lijek Iclusig uzima se peroralno.
English: Common rash pruritic, exfoliative rash, erythema, alopecia, skin exfoliation, night sweats, hyperhidrosis, petechia, ecchymosis, pain of skin, dermatitis exfoliative, hyperkeratosis, skin hyperpigmentation
Croatian: hiperhidroza, petehije, ekhimoze, bolna koža, eksfolijativni dermatitis, hiperkeratoza, hiperpigmentacija kože
English: Iclusig is associated with pancreatitis.
Croatian: Pankreatitis i serumska lipaza Liječenje lijekom Iclusig je povezano s pankreatitisom.
English: • Iclusig should be withheld and resumed at 30 mg after recovery to < Grade 2
Croatian: • Potrebno je obustaviti primjenu lijeka Iclusig i nastaviti s dozom od 30 mg nakon oporavka na < stupanj 2 Pojava uz 30 mg:
English: Factors other than dose may also contribute to this risk of arterial occlusion.
Croatian: Riziku arterijske okluzije mogu pridonijeti i drugi čimbenici osim doze.
English: Table 7 Efficacy of Iclusig in resistant or intolerant chronic phase CML patients Overall (N=267)
Croatian: Tablica 7 Djelotvornost lijeka Iclusig u bolesnika u kroničnoj fazi KML-a koji su rezistentni ili intolerantni
English: • Iclusig should be interrupted and resumed at 15 mg after recovery to ≤ Grade 1, or recovery to pretreatment grade Occurrence at 15 mg:
Croatian: • Potrebno je prekinuti primjenu lijeka Iclusig i nastaviti s dozom od 15 mg nakon oporavka na ≤ stupanj 1 ili oporavka na stupanj prije liječenja
English: Patients may require urgent clinical intervention for hypertension associated with confusion, headache, chest pain, or shortness of breath.
Croatian: Za hipertenziju povezanu sa zbunjenošću, glavoboljom, boli u prsištu ili nedostatkom zraka bolesnicima može biti potrebna hitna klinička intervencija.
English: Retinal venous occlusions associated in some cases with permanent visual impairment or vision loss have occurred in Iclusig-treated patients.
Croatian: U bolesnika liječenih Iclusigom bilo je pojava venske okluzije mrežnice, u nekim slučajevima povezane s trajnim oštećenjem ili gubitkom vida.
English: Iclusig 15 mg film-coated tablets
Croatian: Iclusig 15 mg filmom obložene tablete
English: • Iclusig should be withheld and resumed at 15 mg after recovery to < Grade 2
Croatian: • Potrebno je obustaviti primjenu lijeka Iclusig i nastaviti s dozom od 15 mg nakon oporavka na < stupanj 2 Pojava uz 15 mg:
English: Table 3 Recommended dose modifications for hepatic toxicity Elevation of liver transaminase > 3 × ULN*
Croatian: Tablica 3 Preporučene prilagodbe doze u slučaju hepatotoksičnosti
English: Iclusig should be interrupted immediately in case of arterial occlusion.
Croatian: U slučaju arterijske okluzije liječenje Iclusigom mora se odmah prekinuti.
English: • Iclusig should be withheld and resumed at 30 mg after recovery to ANC ≥ 1.5 x 109/L and platelet ≥ 75 x 109/L Recurrence at 30 mg:
Croatian: • Potrebno je obustaviti primjenu lijeka Iclusig i nastaviti s dozom od 30 mg nakon oporavka ABN na ≥ 1,5 x 109/l te trombocita na ≥ 75 x 109/l
English: Caution is recommended when administering Iclusig to patients with hepatic impairment (see sections 4.2 and 4.4).
Croatian: Preporučuje se oprez prilikom primjene lijeka Iclusig u bolesnika s oštećenjem jetre (vidjeti dijelove 4.4 i 5.2).
English: Substances that may increase ponatinib serum concentrations
Croatian: Tvari koje mogu povećati serumske koncentracije ponatiniba Inhibitori CYP3A
English: • a severe side effect occurs, not affecting the blood
Croatian: • ako dođe do teških nuspojava koje ne zahvaćaju krv - upala gušterače.
English: Substances that may have their serum concentrations altered by ponatinib
Croatian: Tvari čija se koncentracija u serumu mijenja pod utjecajem ponatiniba Supstrati transportera
English: Persistent grade 2 (longer than 7 days)
Croatian: Porast vrijednosti jetrene transaminaze > 3 x GGN* Perzistirajući 2. stupanj (dulje od sedam dana) 3. ili viši stupanj
English: Name and address of the manufacturers responsible for batch release
Croatian: Nazivi i adrese proizvođača odgovornih za puštanje serije lijeka u promet Haupt Pharma - AMAREG GmbH
English: Adverse reactions
Croatian: Citogenetički odgovor
English: Caution should be exercised and a reduction of the starting dose of Iclusig to 30 mg should be considered with concurrent use of strong CYP3A inhibitors such as clarithromycin, indinavir,
Croatian: Treba biti oprezan i razmotriti smanjenje početne doze lijeka Iclusig na 30 mg kod istovremene primjene s jakim inhibitorima CYP3A kao što su klaritromicin, indinavir, itrakonazol, ketokonazol, nefazodon, nelfinavir, ritonavir, sakvinavir, telitromicin, troleandomicin, vorikonazol i sok grejpfruta.
English: Common vision blurred, dry eye, periorbital oedema, eyelid oedema, conjunctivitis, visual impairment
Croatian: Često zamagljen vid, suhe oči, periorbitalni edem,
English: Common side effects (may affect up to 1 in 10 people):
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba)
English: Caution is recommended when administering Iclusig to patients with hepatic impairment (see sections 4.2 and
Croatian: Preporučuje se oprez prilikom primjene lijeka Iclusig u bolesnika s oštećenjem jetre (vidjeti dijelove 4.2 i 5.2).
English: NAME OF THE MEDICINAL PRODUCT Iclusig 45 mg film-coated tablets ponatinib
Croatian: Iclusig 45 mg filmom obložene tablete ponatinib
English: Each film-coated tablet contains 45 mg of ponatinib (as hydrochloride).
Croatian: Svaka filmom obložena tableta sadrži 45 mg ponatiniba (u obliku ponatinibklorida).
English: NAME OF THE MEDICINAL PRODUCT Iclusig 30 mg film-coated tablets ponatinib
Croatian: Iclusig 30 mg filmom obložene tablete ponatinib
English: Each 30 mg film-coated tablet contains 30 mg ponatinib (as ponatinib hydrochloride).
Croatian: Svaka filmom obložena tableta sadrži 30 mg ponatiniba (u obliku ponatinibklorida).
English: Haupt Pharma - AMAREG GmbH Donaustaufer Strasse 378 93055 Regensburg Germany
Croatian: Donaustaufer Strasse 378
English: Unchanged ponatinib accounted for 24% and < 1% of the administered dose in faeces and urine, respectively, with the remainder of the dose comprising metabolites.
Croatian: primijenjene doze u fecesu odnosno u mokraći s preostalom doza koju sačinjavaju metaboliti.
English: Each film-coated tablet contains 15 mg of ponatinib (as hydrochloride).
Croatian: Svaka filmom obložena tableta sadrži 15 mg ponatiniba (u obliku ponatinibklorida).
English: 180 tablets
Croatian: 30 tableta 60 tableta 180 tableta
English: - pancreas inflammation.
Croatian: disfonija, plućna hipertenzija
English: (95% CI) a Primary endpoint for CP-CML Cohorts was MCyR, which combines both complete (No detectable
Croatian: (95% CI) a Primarni ishod za kohorte u kroničnoj fazi KML-a bio je MCyR, koji kombinira i kompletne (stanice Ph+ ne mogu se uočiti) i parcijalne (1% do 35% Ph+ stanica) citogenetičke odgovore.
English: NAME OF THE MEDICINAL PRODUCT Iclusig 15 mg film-coated tablets ponatinib
Croatian: Iclusig 15 mg filmom obložene tablete ponatinib
English: Myelosuppression was generally reversible and usually managed by withholding Iclusig temporarily or reducing the dose (see section 4.2).
Croatian: Mijelosupresija je obično reverzibilna i najčešće prolazi nakon privremenog prestanka primjene lijeka
English: Uncommon retinal vein thrombosis, retinal vein occlusion, retinal artery occlusion
Croatian: Manje često tromboza vene mrežnice, okluzija vene mrežnice, okluzija arterije mrežnice
English: Severe haemorrhage, including fatalities, occurred in Iclusig-treated patients.
Croatian: U bolesnika liječenih Iclusigom zabilježena je teška hemoragija, uključujući i smrtne slučajeve.
English: The full EPAR for Ristaben can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Ristaben nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This authorisation was based on the authorisation granted to Januvia in 2007 (‘informed consent').
Croatian: Odobrenje se temeljilo na odobrenju danom cjepivu Januvia 2007. godine („informirani pristanak”).
English: Ristaben is taken at a dose of 100 mg once a day.
Croatian: Ristaben se uzima u dozi od 100 mg jednom na dan.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ristaben on 15 March 2010.
Croatian: Europska komisija izdaje odobrenje za stavljanje u promet koje za lijek Ristaben vrijedi na prostoru Europske unije od 15. ožujka 2010.
English: It works by blocking the breakdown of ‘incretin' hormones in the body.
Croatian: Djeluje inhibirajući razgradnju „inkretinskih” hormona u tijelu.
English: Ristaben was more effective than placebo when it was taken alone or in combination with other diabetes medicines.
Croatian: Ristaben je bio djelotvorniji od placeba kada se uzimao samostalno ili u kombinaciji s drugim lijekovima za dijabetes.
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 Ristaben.
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 i svoje preporuke za uporabu lijeka Ristaben.
English: What measures are being taken to ensure the safe and effective use of Ristaben
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ristaben?
English: This is a summary of the European Public Assessment Report (EPAR) for Ristaben.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Ristaben.
English: For more information about treatment with Ristaben, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Ristaben pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: The active substance in Ristaben, sitagliptin, is a dipeptidyl-peptidase-4 (DPP 4) inhibitor.
Croatian: Djelatna tvar u lijeku Ristaben, saksagliptin, je inhibitor dipeptidil-peptidaze4 (DPP -4).
English: If Ristaben is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to reduce the risk of hypoglycaemia (low blood sugar levels).
Croatian: Ako se Ristaben uzima s sulfonilurejom ili inzulinom, doza sulfonilureja ili inzulina možda će se trebati smanjiti kako bi se smanjio rizik od hipoglikemije (niskih razina šećera u krvi).
English: In all of the studies, the main measure of effectiveness was the change in the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Croatian: U svim ispitivanjima, glavna mjera djelotvornosti bila je promjena u razini tvari u krvi naziva glikozilirani hemoglobin (HbA1c), koji ukazuje koliko se dobro kontrolira glukoza u krvi.
English: Serious side effects reported with Ristaben include pancreatitis (inflammation of the pancreas) and hypersensitivity (allergic reactions).
Croatian: Ozbiljne nuspojave prijavljene s lijekom Ristaben uključuju pankreatitis (upalu gušterače) i preosjetljivost (alergijske reakcije).
English: • four of the studies compared Ristaben with placebo (a dummy treatment).
Croatian: • četiri od navedenih ispitivanja usporedila su Ristaben s placebom (lažnim liječenjem).
English: A risk management plan has been developed to ensure that Ristaben is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Ristaben.
English: Ristaben was studied in nine studies involving almost 6,000 patients with type 2 diabetes whose blood glucose levels were not adequately controlled:
Croatian: Ristaben je ispitan u devet ispitivanja koja su obuhvatila gotovo 6000 bolesnika s dijabetesom tipa 2 čije razine u krvi nisu bile primjereno kontrolirane: