FrancophonIA/ELRC3.0 huggingface dataset:
English: PAES: In order to investigate the efficacy in elderly patients, the MAH should conduct and submit the results of A2408, a study to assess the efficacy and safety of midostaurin in combination with standard chemotherapy during induction and consolidation, followed by 12 months of midostaurin monotherapy in adult patients (aged ≥18 years) with newly diagnosed FLT3-mutated AML.
Croatian: PAES: Da bi se ispitala djelotvornost u starijih bolesnika, nositelj odobrenja treba provesti i dostaviti rezultate A2408, ispitivanja kojim se ocjenjuje djelotvornost i sigurnost midostaurina u kombinaciji sa standardnom kemoterapijom tijekom indukcije i konsolidacije, nakon čega slijedi 12 mjeseci monoterapije midostaurinom u odraslih bolesnika (u dobi od ≥ 18 godina) s novodijagnosticiranim FLT3 mutiranim AML-om.
English: Sinus tachycardia
Croatian: Sinusna tahikardija često
English: After 100 mg bid multiple oral doses of midostaurin the Cmin,ss plasma midostaurin in AML and ASM, SMAHN, MCL patients were 919 and 1060 ng/ml, respectively.
Croatian: Nakon višestrukih peroralnih doza midostaurina od 100 mg dvaput na dan, Cmin,ss midostaurina u plazmi u bolesnika s AML-om, odnosno s ASM-om, SM-AHN-om, MCL-om bio je 919, odnosno 1060 ng/ml.
English: Interrupt Rydapt for 3 days (6 doses), then resume at 50 mg twice daily and, if tolerated, gradually increase to 100 mg twice daily.
Croatian: Prekinuti primjenu Rydapta na 3 dana (6 doza), zatim nastaviti u dozi od 50 mg dvaput na dan te, ako se podnosi, postupno povećati na 100 mg dvaput na dan.
English: The most frequent Grade 3/4 ADRs were febrile neutropenia (83.5%), lymphopenia (20.0%), device-related infection (15.7%), exfoliative dermatitis (13.6%), hyperglycaemia (7.0%) and nausea (5.8%).
Croatian: Najučestalije nuspojave 3./4. stupnja bile su febrilna neutropenija (83,5%), limfopenija (20,0%), infekcija povezana s uređajem (15,7%), eksfolijativni dermatitis (13,6%), hiperglikemija (7,0%) i mučnina (5,8%).
English: Hypercalcaemia*
Croatian: Hiperkalcijemija*
English: The most frequent Grade 3/4 laboratory abnormalities were absolute lymphocyte count decreased (45.8%), ANC decreased (26.8%), hyperglycaemia (19%), and lipase increased (17.6%).
Croatian: Najučestalije laboratorijske abnormalnosti 3./4. stupnja bile su sniženi apsolutni broj limfocita (45,8%), sniženi ABN (26,8%), hiperglikemija (19%) i povišena lipaza (17,6%).
English: primary endpoint;
Croatian: Mjera primarnog ishoda;
English: Infections and infestations Device-related infection
Croatian: Infekcije i infestacije Infekcija povezana s uređajem
English: 56 (2 packs of 28) capsules 112 (4 packs of 28) capsules
Croatian: 56 (2 pakiranja po 28) kapsula 112 (4 pakiranja po 28) kapsula
English: Hypernatraemia*
Croatian: Hipernatrijemija*
English: Tell your doctor, pharmacist or nurse straight away if you notice any of the following: - weakness, spontaneous bleeding or bruising, frequent infections with signs such as fever, chills,
Croatian: Odmah se obratite svom liječniku, ljekarniku ili medicinskoj sestri ako primijetite bilo što od sljedećeg: - slabost, spontano krvarenje ili stvaranje modrica, učestale infekcije sa znakovima kao što su vrućica, zimica, grlobolja ili ranice u ustima (znakovi niske razine krvnih stanica).
English: 9/l, then resume at 50 mg twice daily.
Croatian: 9/l, zatim nastaviti primjenu u dozi od 50 mg dvaput na dan.
English: ANC decreased*
Croatian: Snižen ABN*
English: 2.8 Common
Croatian: 4.8 Nuspojave
English: Cytochrome P450 induction
Croatian: Indukcija citokroma P450
English: 33.9 months (95% CI: 20.7, 42), than for KIT D816V wild type or unknown patients, i.e. 10 months (95% CI: 6.9, 17.4).
Croatian: Međutim, medijan preživljenja za KIT D816V pozitivne bolesnike bio je duži, tj. 33,9 mjeseci (95% CI: 20,7; 42), nego za bolesnike s KIT D816V mutacijom divljeg ili nepoznatog tipa, tj. 10 mjeseci (95% CI: 6,9; 17,4).
English: Transporter drug-drug interactions
Croatian: Interakcija između lijekova putem transportera
English: Discontinue Rydapt if low ANC persists for >21 days and is suspected to be related to Rydapt.
Croatian: Obustaviti primjenu Rydapta ako niski ABN ustraje > 21 dan i ako postoji sumnja da je povezan s Rydaptom.
English: Overall Survival (OS) Median OS in months (95% CI)
Croatian: Ukupno preživljenje (OS) Medijan OS-a u mjesecima (95% CI)
English: Based on in vitro data, midostaurin and its active metabolites, CGP52421 and CGP62221, are considered inhibitors and may potentially cause increases in exposure of co-administered medicinal products primarily cleared by CYP1A2, CYP2D6, CYP2C8, CYP2C9, CYP2E1 and CYP3A4/5.
Croatian: Na temelju in vitro podataka, midostaurin i njegovi aktivni metaboliti, CGP52421 i CGP62221, smatraju se inhibitorima i potencijalno mogu uzrokovati povećanja izloženosti istodobno primijenjenim lijekovima čiji se klirens primarno odvija putem CYP1A2, CYP2D6, CYP2C8, CYP2C9, CYP2E1 i CYP3A4/5.
English: Overall 95% CI
Croatian: Ukupno 95% CI
English: Based on in vitro data, midostaurin and/or its metabolites have the potential to induce CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 and CYP3A4/5 enzymes.
Croatian: Na temelju in vitro podataka, midostaurin i/ili njegovi metaboliti imaju potencijal induciranja CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 i CYP3A4/5 enzima.
English: Enzyme drug-drug interactions
Croatian: Interakcije između lijekova putem enzima
English: Based on in vitro data, midostaurin and its active metabolites, CGP52421 and CGP62221, are also considered inducers and may cause decreases in exposure of co-administered medicinal products primarily cleared by CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 and CYP3A4/5 (see section 4.5).
Croatian: Na temelju in vitro podataka, midostaurin i njegovi aktivni metaboliti, CGP52421 i CGP62221, također se smatraju induktorima i mogu uzrokovati smanjenja izloženosti istodobno primijenjenih lijekova čiji se klirens prvenstveno odvija putem CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 i CYP3A4/5 (vidjeti dio 4.5).
English: Cardiac disorders Hypotension
Croatian: Srčani poremećaji Hipotenzija
English: Patients with newly diagnosed FLT3-mutated AML as determined by a clinical study assay were randomised (1:1) to receive midostaurin 50 mg twice daily (n=360) or placebo (n=357) sequentially in combination with standard daunorubicin (60 mg/m daily on days 1-3) / cytarabine (200 mg/m daily on days 1-7) induction and high-dose cytarabine (3 g/m every 12 hours on days 1, 3, 5) consolidation, followed by continuous midostaurin or placebo treatment according to initial assignment for up to 12 additional cycles (28 days/cycle).
Croatian: Bolesnici s novodijagnosticiranim AML-om s FLT3 mutacijom utvrđenom kliničkim testom bili su randomizirani (1:1) na primanje midostaurina 50 mg dvaput na dan (n=360) ili placeba (n=357) sekvencijski u kombinaciji sa standardnom indukcijom daunorubicinom (60 mg/m na dan od
English: median (95% CI)
Croatian: medijan (95% CI)
English: Based on in vitro data, midostaurin and/or its metabolites have the potential to inhibit CYP1A2, CYP2D6, CYP2C8, CYP2C9, CYP2E1 and CYP3A4/5 enzymes.
Croatian: Na temelju in vitro podataka, midostaurin i/ili njegovi metaboliti imaju potencijal inhibiranja CYP1A2, CYP2D6, CYP2C8, CYP2C9, CYP2E1 i CYP3A4/5 enzima.
English: NE (17.3, NE)
Croatian: NP (17,3; NP)
English: NE (25.7, NE) 17.6 (12.7, 46.3) 0.68 (0.52, 0.89) 0.0023
Croatian: NP (25,7; NP) 17,6 (12,7; 46,3) 0,68 (0,52; 0,89) 0,0023
English: Rydapt 25 mg soft capsules midostaurin
Croatian: Rydapt 25 mg meke kapsule midostaurin
English: NE (4.1, NE)
Croatian: NP (4,1; NP)
English: Secondary endpoints Median duration of response, months (95% CI)
Croatian: Medijan trajanja odgovora, mjeseci (95% CI)
English: - if you are already taking any of the following medicines: medicines used to treat tuberculosis, such as rifampicin; medicines used to treat epilepsy, such as carbamazepine or phenytoin; enzalutamide, a medicine used to treat prostate cancer; St. John's Wort (also known as Hypericum perforatum), a herbal medicine used to treat depression.
Croatian: Ako mislite da biste mogli biti alergični, upitajte svog liječnika za savjet. - ako već uzimate bilo koji od sljedećih lijekova: lijekove koji se koriste za liječenje tuberkuloze, kao što je rifampicin; lijekove koji se koriste za liječenje epilepsije, kao što je karbamazepin ili fenitoin; enzalutamid, lijek koji se koristi za liječenje raka prostate; gospinu travu (poznata i pod imenom Hypericum perforatum), biljni lijek koji se koristi za liječenje depresije.
English: Discontinue Rydapt if low haemoglobin persists for >21 days and is suspected to be related to Rydapt.
Croatian: Obustaviti primjenu Rydapta ako niski hemoglobin ustraje > 21 dan i ako postoji sumnja da je povezan s Rydaptom.
English: Infections and infestations Urinary tract infection
Croatian: Infekcije i infestacije Infekcija mokraćnog sustava
English: Excipients
Croatian: Ispitanici
English: Rydapt 25 mg soft capsules
Croatian: Rydapt 25 mg meke kapsule
English: Tell your doctor, pharmacist or nurse straight away if you get any of these symptoms during treatment with Rydapt: - if you have fever, sore throat or mouth ulcers, because these may indicate that your white blood cell count is low.
Croatian: Odmah obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako primijetite bilo koji od ovih simptoma tijekom liječenja Rydaptom: - ako imate vrućicu, grlobolju ili ulceracije u ustima, zato što oni mogu ukazivati na to da Vam je broj bijelih krvnih stanica nizak. - ako imate nove ili pogoršane simptome kao što su vrućica, kašalj sa sluzi ili bez nje, bol u grudima, poteškoće s disanjem ili nedostatak zraka, zato što bi to mogli biti znaci infekcija ili problema s plućima.
English: Sinusitis
Croatian: Sinusitis često
English: The most frequent Grade 3/4 laboratory abnormalities were ANC decreased (85.8%), haemoglobin decreased (78.5%), ALT increased (19.4%) and hypokalaemia
Croatian: Najučestalije laboratorijske abnormalnosti 3./4. stupnja bile su sniženi ABN (85,8%), sniženi hemoglobin (78,5%), povišeni ALT (19,4%) i hipokalijemija (13,9%).
English: Common (may affect up to 1 in every 10 people) - involuntary shaking of the body - cough with phlegm, chest pain, fever (bronchitis) - cold sores in the mouth due to viral infection (oral herpes) - painful and frequent urination (cystitis) - feeling of pressure or pain in the cheeks and forehead (sinusitis) - red, swollen painful rash on any part of the skin (erysipelas) - shingles (herpes zoster) - disturbance in attention - feeling dizzy with spinning sensation (vertigo) - bruising (haematoma) - upset stomach, indigestion - feeling weak (asthenia) - chills - generalised swelling (oedema) - increased weight - contusion (bruises) - falls - dizziness, light-headedness (low blood pressure) - sore throat
Croatian: Često (mogu se javiti u do 1 na 10 osoba) - nevoljno drhtanje tijela - kašalj sa sluzi, bol u prsnom košu, vrućica (bronhitis) - mjehurići i ranice u ustima zbog virusne infekcije (oralni herpes) - bolno i često mokrenje (cistitis) - osjećaj pritiska ili boli u obrazima i čelu (sinusitis) - crven, natekao bolni osip na bilo kojem dijelu kože (erizipel) - herpes zoster - poremećaj pažnje - omaglica s osjećajem vrtnje (vrtoglavica) - nastajanje modrica (hematom) - nelagoda u želucu, probavne tegobe - osjećaj slabosti (astenija) - zimica - generalizirano oticanje (edem) - povećana tjelesna težina - kontuzije (podljevi) - padovi - omaglica, ošamućenost (nizak krvni tlak) - grlobolja
English: Rydapt is for oral use.
Croatian: Način primjene Rydapt je namijenjen za primjenu kroz usta.
English: Very common (may affect more than 1 in 10 people) - infection at catheter site - red or purple, flat, pinhead spots under the skin (petechiae) - problems falling asleep (insomnia) - headache - shortness of breath, laboured breathing (dyspnoea) - dizziness, light-headedness (low blood pressure) - nose bleeds - throat pain (laryngeal pain) - mouth sores (stomatitis) - nausea, vomiting - upper abdominal pain - haemorrhoids (piles) - excessive sweating - skin rash with flaking or peeling (exfoliative dermatitis) - back pain - joint pain (arthralgia) - fever - thirst, high urine output, dark urine, dry flushed skin (signs of high levels of sugar in the blood,
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba) - infekcija na mjestu uvođenja katetera - crvene ili ljubičaste, sitne plosnate točkice ispod kože (petehije) - problemi s usnivanjem (nesanica) - glavobolja - nedostatak zraka, otežano disanje (dispneja) - omaglica, ošamućenost (niski krvni tlak) - krvarenja iz nosa - bol u grlu (laringealna bol) - ranice u ustima (stomatitis) - mučnina, povraćanje - bol u gornjem dijelu trbuha - hemoroidi (šuljevi) - prekomjerno znojenje - kožni osip uz perutanje ili ljuštenje (eksfolijativni dermatitis) - bol u leđima - bol u zglobovima (artralgija) - vrućica - žeđ, povećana proizvodnja mokraće, tamna mokraća, suha crvena koža (znakovi visokih razina šećera u krvi, što se naziva hiperglikemijom)
English: How to store Rydapt
Croatian: Kako čuvati Rydapt
English: Common (may affect up to 1 in every 10 people) - upper respiratory tract infection - nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness and twitching (signs of high levels of calcium in the blood, known as hypercalcaemia) - fainting - involuntary shaking of the body - headache, dizziness (high blood pressure) - fast heart beat (sinus tachycardia) - collection of fluid around the heart, which, if severe, can decrease the heart's ability to pump blood (pericardial effusion) - fluid collection in the lungs/chest cavity, which, if severe, could make you breathless (pleural effusion) - sore throat and a runny nose - swelling of the eyelid - discomfort in the anus and rectum - abdominal pain, nausea, vomiting, constipation (abdominal discomfort) - dry skin - eye pain, blurred vision, intolerance to light (keratitis) - neck pain - bone pain - pain in limbs - increased weight - blood clotted in the catheter - abnormal blood test results which can indicate to your doctor how well certain parts of your body are functioning: high levels of uric acid
Croatian: (znakovi visokih razina kalcija u krvi, što se naziva hiperkalcijemija) - nesvjestica - nevoljno drhtanje tijela - glavobolja, omaglica (visoki krvni tlak) - ubrzani otkucaji srca (sinusna tahikardija) - nakupljanje tekućine oko srca, koje, ako je izraženo, može smanjiti sposobnost srca da pumpa krv (perikardijalni izljev) - nakupljanje tekućine u plućima/prsnoj šupljini koje, ako je vrlo izraženo, može dovesti do nedostatka zraka (pleuralni izljev) - grlobolja i curenje nosa - oticanje kapaka - nelagoda u anusu i rektumu - bol u trbuhu, mučnina, povraćanje, zatvor (nelagoda u trbuhu) - suha koža - bol u oku, zamagljeni vid, nepodnošenje svjetlosti (keratitis) - bol u vratu - bol u kostima - bol u udovima - povećana tjelesna težina - zgrušana krv u kateteru - odstupanja u rezultatima krvnih pretraga koje Vašem liječniku mogu ukazivati na to koliko dobro funkcioniraju određeni dijelovi Vašeg tijela: visoke razine urične kiseline
English: Dry skin
Croatian: Suhoća kože često
English: General disorders and administration site conditions Oedema peripheral
Croatian: Opći poremećaji i reakcije na mjestu primjene Periferni edem
English: Abdominal pain upper
Croatian: Bol u gornjem dijelu abdomena
English: 9/l, then resume at 50 mg twice daily and, if tolerated, increase to 100 mg twice daily.
Croatian: 9/l, zatim nastaviti u dozi od 50 mg dvaput na dan te, ako se podnosi, povećati na 100 mg dvaput na dan.
English: Reporting of side effects
Croatian: Mjere sekundarnog ishoda
English: N.E.
Croatian: A.
English: known as hyperglycaemia) - yellow skin and eyes (sign of high bilirubin in the blood) - abnormal blood test results which indicate possible problems with the pancreas (high levels of lipase or amylase) and liver (high levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST))
Croatian: (visoke razine lipaze ili amilaze) i jetrom (visoke razine alanin aminotransferaze (ALT) ili aspartat aminotransferaze (AST))
English: 9/l, then resume Rydapt at 50 mg twice daily and, if tolerated, increase to 100 mg twice daily.
Croatian: 9/l, zatim nastaviti primjenu Rydapta u dozi od 50 mg dvaput na dan te, ako se podnosi, povećati na 100 mg dvaput na dan.
English: Nausea, vomiting and diarrhoea were observed in AML, ASM, SM-AHN and MCL patients.
Croatian: U bolesnika s AML-om, ASM-om, SM-AHN-om i MCL-om opaženi su mučnina, povraćanje i proljev.
English: Discontinue Rydapt if low platelet count persists for >21 days and is suspected to be related to Rydapt.
Croatian: Obustaviti primjenu Rydapta ako niski broj trombocita ustraje > 21 dan i ako postoji sumnja da je povezan s Rydaptom.
English: PAES: In order to investigate the efficacy in elderly patients, the MAH should submit the final results of a phase II ADE02T study of midostaurin in combination with intensive induction, consolidation including allogenic SCT and single agent maintenance in patients aged 18-70 with FLT3 ITD mutated AML.
Croatian: Ispitivanje djelotvornosti lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PAES): Da bi se ispitala djelotvornost u starijih bolesnika, nositelj odobrenja treba dostaviti konačne rezultate ADE02T ispitivanja faze II midostaurina u kombinaciji s intenzivnom indukcijom i konsolidacijom, uključujući alogeni TMS, kao i u monoterapiji održavanja u bolesnika u dobi od 18 do 70 godina s FLT3 ITD mutiranim AML-om.
English: Pneumonia
Croatian: Pneumonija često
English: No dedicated renal impairment study was conducted for midostaurin.
Croatian: Nije provedeno nijedno posebno ispitivanje midostaurina kod oštećenja bubrega.
English: Males 95% CI
Croatian: Muškarci 95% CI
English: Respiratory, thoracic and mediastinal disorders Dyspnoea
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Dispneja
English: Median DFS in months (95% CI) 26.7 (19.4, NE) 15.5 (11.3, 23.5) 0.71 (0.55, 0.92) 0.0051 Complete Remission (CR) within 60 days of treatment start
Croatian: 26,7 (19,4; NP) 15,5 (11,3; 23,5) 0,71 (0,55; 0,92) 0,0051
English: Upper respiratory tract infection
Croatian: Infekcija gornjeg dijela dišnog sustava
English: Rydapt dosing
Croatian: Doziranje Rydapta
English: Gastrointestinal haemorrhage
Croatian: Gastrointestinalno krvarenje često
English: Interrupt Rydapt for the remainder of the cycle.
Croatian: Plućni infiltrati 3./4. stupnja Prekinuti primjenu Rydapta u ostatku ciklusa.
English: ALT increased*
Croatian: Povišen ALT*
English: sore throat or mouth ulcers (signs of a low level of blood cells) - fever, cough, difficult or painful breathing, wheezing, chest in pain when breathing (signs of pneumonia) - infections, fever, dizziness, light-headedness, decreased urination, rapid pulse, rapid breathing
Croatian: Odmah se obratite svom liječniku, ljekarniku ili medicinskoj sestri ako primijetite bilo što od sljedećeg: - slabost, spontano krvarenje ili stvaranje modrica, učestale infekcije sa znakovima kao što su vrućica, zimica, grlobolja ili ranice u ustima (znakovi niske razine krvnih stanica). - vrućica, kašalj, otežano ili bolno disanje, piskanje pri disanju, bol u prsima pri disanju (znakovi upale pluća). - infekcije, vrućica, omaglica, ošamućenost, smanjeno mokrenje, ubrzan puls, ubrzano disanje
English: Oedema
Croatian: Omaglica
English: sore throat or mouth ulcers (signs of a low level of blood cells) - severe shortness of breath, laboured and unusually rapid breathing, dizziness, light-headedness,
Croatian: - izraziti nedostatak zraka, otežano ili neuobičajeno brzo disanje, omaglica, ošamućenost,
English: Anorectal discomfort
Croatian: Anorektalna nelagoda često
English: Neck pain
Croatian: Pvrijedno st
English: ASM, SM-AHN and MCL The recommended starting dose of Rydapt is 100 mg orally twice daily.
Croatian: ASM, SM-AHN i MCL Preporučena početna doza
English: Median EFS in months, considering CRs within 60 days of treatment start (95% CI)
Croatian: Potpuna remisija (CR) unutar 60 dana od početka liječenja
English: No dosage adjustment is necessary for patients with baseline mild or moderate hepatic impairment.
Croatian: Za bolesnike s blagim ili umjerenim oštećenjem bubrega nije potrebna prilagodba doze.
English: Bronchitis
Croatian: Proljev
English: Tabulated lists of adverse drug reactions
Croatian: SAŽETAK OPISA SVOJSTAVA LIJEKA
English: Severe hepatic impairment
Croatian: Teško oštećenje bubrega
English: Diarrhoea
Croatian: Hemoroidi
English: Vascular disorders Hypotension
Croatian: Krvožilni poremećaji Hipotenzija često
English: Ear and labyrinth disorders Vertigo
Croatian: Poremećaji uha i labirinta Vrtoglavica često
English: INTERMEDIATE CARTON
Croatian: UNUTARNJA KUTIJA
English: Cystitis
Croatian: Kašalj
English: Median EFS in months, considering CRs any time during induction (95% CI)
Croatian: Disease Free Survival) Medijan DFS-a u mjesecima (95% CI)
English: Keratitis
Croatian: Proizvođač
English: Very common (may affect more than 1 in 10 people) - urinary tract infection - upper respiratory tract infection - headache - dizziness - shortness of breath, laboured breathing (dyspnoea) - cough - fluid collection in the lungs/chest cavity, which, if severe, could make you breathless (pleural effusion) - nose bleeds - nausea, vomiting - diarrhoea - constipation - rapid weight gain, swelling of the limbs (calves, ankles)
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba) - infekcija mokraćnog sustava - infekcija gornjeg dijela dišnog sustava - glavobolja - omaglica - nedostatak zraka, otežano disanje (dispneja) - kašalj - nakupljanje tekućine u plućima/prsnoj šupljini koje, ako je vrlo izraženo, može dovesti do nedostatka zraka (pleuralni izljev) - krvarenja iz nosa - mučnina, povraćanje - proljev - zatvor - brzi porast tjelesne težine, oticanje udova (listova, gležnjeva) - osjećaj izrazitog umora - vrućica - žeđ, povećana proizvodnja mokraće, tamna mokraća, suha crvena koža (znakovi visokih razina šećera u krvi, što se naziva hiperglikemijom) - žutilo kože i očiju (znakovi povišene razine bilirubina u krvi) - odstupanja u rezultatima krvnih pretraga koje ukazuju na moguće probleme s gušteračom
English: Severe renal impairment
Croatian: Orofaringealna bol često
English: 90 (3 x 30) tablets (multipack)
Croatian: 90 (3x30) tableta višestruko pakiranje
English: MA (EU) number (Invented) name Strength
Croatian: Broj rješenja (EU) Ime lijeka Jačina
English: Germany considered that the granting of the marketing authorisation constitutes a potential serious risk to public health.
Croatian: Nizozemska i Njemačka izrazile su sumnju da izdavanje odobrenja za stavljanje u promet predstavlja potencijalan ozbiljan rizik za ljudsko zdravlje.
English: Regarding the results obtained in the fed study (2009-18-PRT-2) it was shown that when compared to the fasting study several subjects did not have a biphasic profile but a continuous profile without an early maximum, whereby methylphenidate concentrations slowly increase after an erratic lag time.
Croatian: Što se tiče rezultata dobivenih u ispitivanju uz hranu (2009-18-PRT-2), pokazano je da kad se usporedi s ispitivanjem natašte, nekoliko ispitanika nije imalo bifazični profil već kontinuirani profil bez ranog maksimuma, gdje su se koncentracije metilfenidata sporo povećavale nakon nepravilnog vremena odgode.
English: • The Committee is of the opinion that bioequivalence was demonstrated under fasting conditions for the immediate and prolonged release phases and under fed conditions for the prolonged release phase.
Croatian: • Povjerenstvo smatra da je bioekvivalencija pokazana u uvjetima natašte za fazu neposrednog i produljenog oslobađanja i u uvjetima uz hranu za fazu produljenog oslobađanja.