natgillin/translations-raw huggingface dataset:
EU/1/17/1243/001 20x1 film-coated tablets EU/1/17/1243/002 60 film-coated tablets EU/1/17/1243/003 60x1 film-coated tablets EU/1/17/1243/004 120 film-coated tablets EU/1/17/1243/005 120x1 film-coated tablets EU/1/17/1243/006 180x1 film-coated tablets EU/1/17/1243/007 20x1 film-coated tablets EU/1/17/1243/008 60 film-coated tablets EU/1/17/1243/009 60x1 film-coated tablets EU/1/17/1243/010 120 film-coated tablets EU/1/17/1243/011 120x1 film-coated tablets EU/1/17/1243/012 180x1 film-coated tablets imatinib teva b.v. 100 mg film-coated tablets
EU/1/17/1243/001 20x1 filmom obloženih tableta EU/1/17/1243/002 60 filmom obloženih tableta EU/1/17/1243/003 60x1 filmom obloženih tableta EU/1/17/1243/004 120 filmom obloženih tableta EU/1/17/1243/005 120x1 filmom obloženih tableta EU/1/17/1243/006 180x1 filmom obloženih tableta EU/1/17/1243/007 20x1 filmom obloženih tableta EU/1/17/1243/008 60 filmom obloženih tableta EU/1/17/1243/009 60x1 filmom obloženih tableta EU/1/17/1243/010 120 filmom obloženih tableta EU/1/17/1243/011 120x1 filmom obloženih tableta EU/1/17/1243/012 180x1 filmom obloženih tableta
EU/1/17/1243/025 30 film-coated tablets EU/1/17/1243/026 30x1 film-coated tablets EU/1/17/1243/027 90 film-coated tablets EU/1/17/1243/028 90x1 film-coated tablets EU/1/17/1243/029 30 film-coated tablets EU/1/17/1243/030 30x1 film-coated tablets EU/1/17/1243/031 90 film-coated tablets EU/1/17/1243/032 90x1 film-coated tablets imatinib teva b.v. 400 mg film-coated tablets
EU/1/17/1243/025 30 filmom obloženih tableta EU/1/17/1243/026 30x1 filmom obloženih tableta EU/1/17/1243/027 90 filmom obloženih tableta EU/1/17/1243/028 90x1 filmom obloženih tableta EU/1/17/1243/029 30 filmom obloženih tableta EU/1/17/1243/030 30x1 filmom obloženih tableta EU/1/17/1243/031 90 filmom obloženih tableta EU/1/17/1243/032 90x1 filmom obloženih tableta
(3 h, q 12 h), day 5
i.v. (3 h, svakih 12 h), dan 5
Results are provided in Table 5.
Rezultati su prikazani u
Dose increases from 600 mg to a maximum of 800 mg (given as 400 mg twice daily) in patients with blast crisis may be considered in the absence of severe adverse drug reaction and severe non-leukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
Povećanja doze od 600 mg do maksimalno 800 mg (dano kao 400 mg dvaput na dan) u bolesnika s blastičnom krizom može se razmotriti u odsustvu teške nuspojave povezane s lijekom i teške neutropenije ili trombocitopenije nepovezane s leukemijom u sljedećim situacijama: progresija bolesti (u bilo kojem trenutku); neuspjeh u postizanju zadovoljavajućeg hematološkog odgovora nakon liječenja u trajanju od najmanje 3 mjeseca; neuspjeh u postizanju citogenetskog odgovora nakon 12 mjeseci liječenja; ili gubitak ranije postignutoga hematološkog i/ili citogenetskog odgovora.
- The other ingredients are mannitol, crospovidone, magnesium stearate and silica colloidal anhydrous.
- Ostali sastojci su manitol, krospovidon, magnezijev stearat i bezvodni koloidni silicijev dioksid.
In thyroidectomy patients receiving levothyroxine, the plasma exposure to levothyroxine may be decreased when imatinib is co-administered (see section 4.4).
U bolesnika koji su tireidektomirani i uzimaju levotiroksin, izloženost levotiroksinu u plazmi može biti smanjena, uz istodobnu primjenu imatiniba(vidjeti dio 4.4) te se stoga preporučuje oprez.
The compound selectively inhibits proliferation and induces apoptosis in Bcr-Abl positive cell lines as well as fresh leukaemic cells from Philadelphia chromosome positive CML and acute lymphoblastic leukaemia (ALL) patients.
Supstancija selektivno inhibira proliferaciju te inducira apoptozu u Bcr-Abl pozitivnim staničnim linijama, kao i u svježim leukemijskim stanicama osoba s Ph+KML-om i ALL
The doctor will tell you how many capsules of Imatinib Teva B.V. to give to your child.
Liječnik će Vam reći koliko kapsula Imatiniba Teva B.V. trebate dati djetetu.
Vindesine 3 mg/m2 i.v., day 1;
Vindezin 3 mg/m2 i.v., dan 1;
VCR 2 mg total dose i.v., days 1, 8, 15, 22;
VCR 2 mg ukupna doza i.v., dani 1, 8, 15, 22;
The age of these patients ranged from 8 to 18 years and imatinib was given in both adjuvant and metastatic settings at doses ranging from 300 to 800 mg daily.
Dob tih bolesnika bila je u rasponu od 8 do 18 godina, a imatinib se primjenjivao kao adjuvantno liječenje i za liječenje metastaza u dozama od 300 do 800 mg na dan.
The total number of deaths were 25 for the 12-month treatment arm and 12 for the 36-month treatment arm.
U kraku s 12-mjesečnim liječenjem umrlo je ukupno 25 bolesnika, a u kraku s 36-mjesečnim
Liver function (transaminases, bilirubin, alkaline phosphatase) should be monitored regularly in patients
U bolesnika koji primaju imatinib potrebno je redovito kontrolirati parametre jetrene funkcije (transaminaze, bilirubin, alkalna fosfataza).
The Kaplan-Meier estimate for survival after 36-month follow-up is 68%.
Kaplan-Meierova procjena za preživljenje nakon 36
Imatinib is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF), PDGF-R, and stem cell factor (SCF), c-Kit, and inhibits PDGF- and SCF-mediated cellular events.
Imatinib je također inhibitor receptorskih tirozin kinaza za faktor rasta koji potječe od trombocita (PDGF), PDGF-R, te inhibira stanična zbivanja posredovana PDGF-om.
Your doctor will tell you exactly how many tablets of Imatinib Teva B.V. to take.
Liječnik će Vam reći točno koliko tableta Imatiniba Teva B.V. trebate uzeti.
If you forget to take Imatinib Teva B.V. - If you forget a dose, take it as soon as you remember.
Ako ste zaboravili dozu, uzmite ju čim se sjetite.
The doctor will tell you how many tablets of Imatinib Teva B.V. to give to your child.
Liječnik će Vam reći koliko tableta Imatiniba Teva B.V. trebate dati djetetu.
Active substances that may have their plasma concentration altered by imatinib Imatinib increases the mean Cmax and AUC of simvastatin (CYP3A4 substrate) 2- and 3.5-fold, respectively, indicating an inhibition of the CYP3A4 by imatinib.
Imatinib povećava srednu vrijednost Cmax i AUC simvastatina (supstrat CYP3A4) za 2-, odnosno 3,5-puta, što ukazuje na to da imatinib inhibira CYP3A4.
Active substances that may increase imatinib plasma concentrations Substances that inhibit the cytochrome P450 isoenzyme CYP3A4 activity (e.g. protease inhibitors such as indinavir, lopinavir/ritonavir, ritonavir, saquinavir, telaprevir, nelfinavir, boceprevir; azole antifungals including ketoconazole, itraconazole, posaconazole, voriconazole; certain macrolides such as erythromycin, clarithromycin and telithromycin) could decrease metabolism and increase imatinib concentrations.
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Djelatne tvari koje mogu povećati koncentracije imatiniba u plazmi Tvari koje inhibiraju djelovanje CYP3A4 izoenzima citokroma P450 (npr. inhibitori proteaze kao što su indinavir, lopinavir/ritonavir, ritonavir, sakvinavir, telaprevir, nelfinavir, boceprevir; azolni antimikotici uključujući ketokonazol, itrakonazol, posakonazol, vorikonazol; određeni makrolidi kao što su eritromicin, klaritromicin i telitromicin) mogle bi smanjiti metabolizam i povećati koncentracije imatiniba.
Some medicines can interfere with the effect of Imatinib Teva B.V. when taken together.
Neki lijekovi mogu utjecati na djelovanje Imatiniba Teva B.V.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku, ljekarniku ili
Within each frequency grouping, undesirable effects are presented in order of frequency, the most frequent
Unutar svake grupe učestalosti nuspojave su prikazane prema redosljedu učestalosti, najučestalije su prve.
Chronic myeloid leukaemia is a form of leukaemia in which certain abnormal white cells (named myeloid cells) start growing out of control.
Kronična mijeloična leukemija je oblik leukemije u kojem određene abnormalne bijele krvne stanice (zvane mijeloidne stanice)
Iron oxide black (E172)
Tinta za označavanje šelak željezov oksid, crni (E172)
All patients achieved complete haematological response, cytogenetic response and/or
Svi su bolesnici postigli kompletni hematološki odgovor, citogenetski odgovor i/ili klinički odgovor.
MTX 15 mg intrathecal, day 1; Methylprednisolone 40 mg intrathecal, day 1
MTX 15 mg intratekalno, dan 1; Metilprednizolon 40 mg intratekalno, dan 1
Methotrexate (5 g/m2 over 24 hours, IV): days 1 and 15
Metotreksat (5 g/m2 kroz 24 sata, i.v.): dani 1 i 15
Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o.
Teva Czech Industries s.r.o.
Safety data from this study seem to be in line with the safety profile of imatinib in Ph+ ALL patients.
Podaci o sigurnosti primjene iz ovog ispitivanja u skladu su sa sigurnosnim profilom imatiniba u
The capsules are approximately 19 mm long and 7 mm wide.
Duljina kapsule je približno 19 mm, a širina iznosi 7 mm.
Teva B.V.
Imatinib Teva B.V.
Immunohistochemistry was routinely performed with Kit antibody (A-4502, rabbit polyclonal antiserum, 1:100; DAKO Corporation, Carpinteria, CA) according to analysis by an avidin-biotin-peroxidase complex method after antigen retrieval.
Nakon pronalaska antigena, imunohistokemijske pretrage su rutinski provedene s Kit protutijelom (A-4502, poliklonski antiserum kunića, 1:100; DAKO Corporation,
Therefore, close monitoring of growth in children under imatinib treatment is recommended (see section
Stoga se preporučuje pažljivo praćenje rasta djece koja se liječe imatinibom (vidjeti dio 4.8).
In addition, thirty-six (36) months of imatinib treatment significantly prolonged overall survival (OS) compared to 12 months of imatinib treatment (HR = 0.45 [0.22, 0.89], p=0.0187) (Table 7, Figure 2).
(OS) u usporedbi s 12 mjeseci liječenja imatinibom (omjer rizika = 0,45 [0,22, 0,89], p=0,0187) (Tablica 7, Slika 2).
Headache2
Blagi
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND
UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
(1 h), days 1-5; VM26 60 mg/m2 i.v.
i.v. (1 h), dani 1-5; VM26 60 mg/m2 i.v. (1 h), dani 1-5
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 this
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
Rash pustular, contusion, sweating increased, urticaria, ecchymosis, increased tendency to bruise, hypotrichosis, skin hypopigmentation, dermatitis exfoliative, onychoclasis, folliculitis, petechiae, psoriasis, purpura, skin hyperpigmentation, bullous eruptions Acute febrile neutrophilic dermatosis (Sweet's syndrome), nail discolouration, angioneurotic oedema, rash vesicular, erythema multiforme, leucocytoclastic vasculitis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis (AGEP) Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and
Svrbež, edem lica, suhoća kože, eritem, alopecija, noćno znojenje, Pustularni osip, kontuzije, pojačano znojenje, urtikarija, ekhimoza, povećana sklonost modricama, hipotrihoza, hipopigmentacija kože, eksfolijativni dermatitis, onihoklazija, folikulitis, petehije, psorijaza, purpura, hiperpigmentacija kože, bulozne erupcije Akutna febrilna neutrofilna dermatoza (Sweetov sindrom), promjena boje nokta, angioedem, vezikularni osip, multiformni eritem, leukocitoklastični vaskulitis, Stevens-Johnsonov sindrom, akutna generalizirana egzantematozna pustuloza (AGEP)
Similar results were observed in patients with malignant gliomas treated with imatinib while taking enzyme-inducing anti-epileptic drugs (EIAEDs) such as carbamazepine, oxcarbazepine and phenytoin.
Slični rezultati su uočeni u bolesnika s malignim gliomima koji su liječeni imatinibom dok su uzimali antiepileptičke lijekove koji induciraju enzime,
One open-label, multicentre, phase II clinical trial (study B2225) was conducted testing imatinib in diverse populations of patients suffering from life-threatening diseases associated with Abl, Kit or PDGFR protein tyrosine kinases.
(studija B2225) za ispitivanje imatiniba u raznim populacijama bolesnika koji boluju od životno ugrožavajućih bolesti povezanih s Abl, Kit ili PDGFR protein tirozin kinazama.
DEX 10 mg/m2 oral, days 1-5;
DEX 10 mg/m2 peroralno, dani 1-5;
In GIST the study drug was discontinued for drug-related adverse reactions in 4% of
primjena ispitivanog lijeka je prekinuta u 4% bolesnika zbog nuspojava povezanih s njegovom
When and how to take Imatinib Teva B.V. - Take Imatinib Teva B.V. with a meal.
Kada i kako uzimati Imatinib Teva B.V.
(1 h), days 28-31, 35-38, 42-45; 6-MP 60 mg/m2 oral, days 26-46
Ara-C 75 mg/m2 i.v. (1 h), dani 28-31, 35-38, 42-45; 6-MP 60 mg/m2 peroralno, dani 26-46
The mechanism and relevance of these findings in the rat carcinogenicity study for humans are not yet
Iz ovih nalaza studije kancerogenosti u štakora još nije razjašnjen mehanizam, kao ni važnost za ljude.
The dose is 800 mg per day (2 capsules), to be taken as one capsule in the morning and a second capsule in the evening.
Doza je 800 mg na dan (2 kapsule), koja se uzima kao jednu kapsula ujutro i druga kapsula
The required number of tablets should be placed in the appropriate volume of beverage (approximately 50 ml for a 100 mg tablet, and 200 ml for a 400 mg tablet) and stirred with a spoon.
(oko 50 ml za tabletu od 100 mg te 200 ml za tabletu od 400 mg) te promiješati žlicom.
From the safety data available, escalating the dose to 800 mg daily in patients progressing at lower doses of 400 mg or 600 mg daily does not seem to affect the safety profile of imatinib.
Prema dostupnim podacima o sigurnosti primjene, izgleda da povećanje doze na 800 mg na dan, u bolesnika kod kojih je došlo do progresije pri nižim dozama od 400 mg ili 600
• Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red blood
• Blijeda koža, umor i nedostatak zraka te tamno obojena mokraća (znakovi snižene razine
G-CSF = granulocyte colony stimulating factor, VP-16 = etoposide, MTX = methotrexate, IV = intravenous, SC = subcutaneous, IT = intrathecal, PO = oral, IM = intramuscular, ARA-C = cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2mercaptoethane sulfonate sodium, iii= or until MTX level is < 0.1 µM, q6h = every 6 hours, Gy= Gray
= u mišić, ARA-C = citarabin, CPM = ciklofosfamid, VCR = vinkristin, DEX = deksametazon, DAUN = daunorubicin, 6-MP = 6merkaptopurin, E.Coli L-ASP = L-asparaginaza, PEG-ASP = PEG asparaginaza, MESNA= natrijev 2merkaptoetan sulfonat, iii= ili dok vrijednost MTX-a ne bude <0,1 µm, Gy= Gray
Pack sizes of 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.
Veličine pakiranja od 30x1 ili 90x1 filmom obloženih tableta u perforiranim blisterima s jediničnim
Imatinib Teva B.V. 400 mg hard capsules are available in pack sizes of 30 or 90 hard capsules in blisters.
Imatinib Teva B.V. 400 mg tvrde kapsule dostupne su u veličinama pakiranja od 30 ili 90 tvrdih Imatinib Teva B.V.
RFS
EXP
Constitutive activation of the PDGF receptor or the Abl protein tyrosine kinases as a consequence of fusion to diverse partner proteins or constitutive production of PDGF have been implicated in the pathogenesis of MDS/MPD, HES/CEL and DFSP.
HES/KEL-a i DFSP-a uključena je ili konstitutivna aktivacija receptora za PDGF ili Abl protein tirozin kinaza koja nastaje kao posljedica fuzije pri čemu se javljaju različiti partnerski proteini ili konstitutivno stvaranje PDGF-a.
Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people):
Manje česte (mogu se javiti kod manje od 1 na 100 ljudi) ili rijetke (mogu se javiti kod manje od 1
If you take more Imatinib Teva B.V. than you should If you have accidentally taken too many capsules, talk to your doctor straight away.
Ako ste zabunom uzeli previše kapsula, odmah se obratite liječniku.
Imatinib Teva B.V. is also a treatment for adults for:
Imatinib Teva B.V. se također koristi kod odraslih i djece za liječenje:
Psychiatric disorders Common:
Pedijatrijski bolesnici:
Population pharmacokinetics
Farmakokinetika u pedijatrijskoj populaciji
Clinical studies in MDS/MPD
U patogenezu MDS/MPB-a,
The usual starting dose is 600 mg to be taken as one capsule of 400 mg plus 2 capsules of 100 mg
Uobičajena početna doza je 600 mg koja se uzima kao jedna kapsula od 400 mg plus 2 kapsule
Complete blood counts must be performed regularly during therapy with imatinib.
Laboratorijske pretrage Tijekom terapije imatinibom potrebno je redovito kontrolirati kompletnu krvnu sliku.
- If you are unable to swallow the capsules, you can open them up and pour the powder into a glass of
- Ako niste u stanju progutati kapsule, možete ih otopiti u čaši negazirane vode ili soka od
Target organs for neoplastic changes were the kidneys, urinary bladder, urethra, preputial and clitoral gland, small intestine, parathyroid glands, adrenal glands and non-glandular stomach.
Ciljni organi neoplastičkih promjena bili su bubrezi, mokraćni mjehur, uretra,
If your daily dose is 800 mg (8 tablets), you should take 4 tablets in the morning and 4 tablets in
Ako Vaša dnevna doza iznosi 800 mg (8 tableta), trebate uzimati 4 tablete ujutro i 4 tablete navečer.
The age of these patients ranged from 2 to 16 years and imatinib was given at dose 300 mg/m2 daily or doses ranging from 200 to 400
Dob tih bolesnika bila je u rasponu od 2 do 16 godina, a imatinib se primjenjivao u dozi od 300 mg/m2 na dan ili u dozama u rasponu od 200 do 400 mg na dan.
• Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of gastrointestinal disorders).
• Teška bol u trbuhu, krv u sadržaju povraćanja, stolici ili mokraći, crne stolice (znakovi
Treatment with imatinib for 36 months was superior to treatment for 12 months in the ITT analysis, i.e. including the entire study population.
U ITT analizi, koja uključuje cijelu populaciju ispitivanja, 36-mjesečno liječenje imatinibom bilo je superiornije od 12-mjesečnog liječenja.
Severe elevation of transaminases (<5%) or bilirubin (<1%) was seen in CML patients and was usually managed with dose reduction or interruption (the median duration of these episodes was approximately one week).
KML-om i obično je liječeno smanjenjem doze ili prekidom terapije (medijan trajanja tih epizoda bio je približno tjedan dana).
Caution should be taken when administering imatinib with inhibitors of the CYP3A4
Stoga je pri primjeni imatiniba s lijekovima koji inhibiraju CYP3A4 potreban oprez.
The dose is 800 mg per day (2 tablets), to be taken as one tablet in the morning and a second tablet in the evening.
Doza je 800 mg na dan (2 tablete), koja se uzima kao jednu tableta ujutro i druga tableta
These patients received imatinib for a median of 47 months (range 24 days - 60 months).
U vrijeme analize, medijan trajanja liječenja bio je 47 mjeseci (24 dana - 60 mjeseci).
imatinib teva b.v. 400 mg hard capsules
Imatinib Teva B.V. 400 mg tvrde kapsule
Imatinib Teva B.V. is a treatment for:
Imatinib Teva B.V. se koristi za liječenje:
12-month treatment arm % (CI)
Stope preživljenja bez recidiva bolesti (%) 12 mjeseci
Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia,
Poremećaji metabolizma i prehrane Hipokalijemija, povećan apetit, hipofosfatemija, smanjen apetit, dehidracija,
If your daily dose is 800 mg (8 capsules), you should take 4 capsules in the morning and 4
Ako Vaša dnevna doza iznosi 800 mg (8 kapsula), trebate uzimati 4 kapsule ujutro i 4 kapsule navečer.
9 Musculoskeletal pain during treatment with imatinib or after discontinuation has been observed in
9 Nakon stavljanja lijeka u promet primijećena je mišićno-koštana bol koja se javlja tijekom liječenja imatinibom ili nakon prekida liječenja.
Pack sizes of 20x1, 60x1, 120x1 or 180x1 hard capsules in perforated unit dose blisters.
Veličine pakiranja od 20x1, 60x1, 120x1 ili 180x1 tvrdih kapsula u perforiranim blisterima s
Table 6 Summary of Z9001 trial RFS analyses by NIH and AFIP risk classifications
Tablica 6 Sažetak analiza preživljenja bez recidiva bolesti u ispitivanju Z9001 prema NIH i
imatinib teva b.v. 100 mg hard capsules
Imatinib Teva B.V. 100 mg tvrde kapsule
If your daily dose is 800 mg (2 tablets), you should take one tablet in the morning and a second
Ako Vaša dnevna doza iznosi 800 mg (2 tablete), trebate uzimati jednu tabletu ujutro i drugu tabletu navečer.
The usual starting dose is 600 mg to be taken as 6 capsules once a day.
Uobičajena početna doza je 600 mg koja se uzima kao 6 kapsula jednom na dan.
CPM (250 mg/m2/dose q12h x 4 doses, iv): Days 3 and 4 PEG-ASP (2500 IUnits/m2, IM): day 4
CPM (250 mg/m2/doza svakih 12 sati x 4 doze, i.v.): Dani 3 i 4 PEG-ASP (2500 IU/m2, i.m.): dan 4
Evaluation by a cardiology specialist, performance of an echocardiogram and determination of serum troponin should therefore be considered in patients with HES/CEL, and in patients with MDS/MPD associated with high eosinophil levels before imatinib is administered.
Prije primjene imatiniba u bolesnika s HES/KEL-om i u bolesnika s MDS/MPD-om povezanim s visokim razinama eozinofila potrebno je razmisliti o specijalističkom kardiološkom pregledu uz ehokardiogram i određivanje serumskog troponina.
Dizziness, paraesthesia, taste disturbance, hypoaesthesia Migraine, somnolence, syncope, peripheral neuropathy, memory impairment, sciatica, restless leg syndrome, tremor, cerebral haemorrhage Increased intracranial pressure, convulsions, optic neuritis
Migrena, pospanost, sinkopa, periferna neuropatija, poremećaj pamćenja, ishijalgija, sindrom nemirnih nogu, tremor, cerebralno krvarenje
Imatinib Teva B.V. 100 mg film-coated tablets Pack sizes of 60 or 120 film-coated tablets in blisters.
100 mg filmom obložene tablete Veličine pakiranja od 60 ili 120 filmom obloženih tableta u blisterima.
Posology for DFSP The recommended dose of Imatinib Teva B.V. is 800 mg/day for adult patients with DFSP.
Za odrasle bolesnike s DFSP-om preporučena doza Imatiniba Teva B.V. iznosi 800 mg/dan.
The usual starting dose is 600 mg to be taken as 6 tablets once a day.
Uobičajena početna doza je 600 mg koja se uzima kao 6 tableta jednom na dan.
Pack sizes of 20x1, 60x1, 120x1 or 180x1 film-coated tablets in perforated unit dose blisters.
Veličine pakiranja od 20x1, 60x1, 120x1 ili 180x1 filmom obloženih tableta u perforiranim blisterima
Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia, hyperglycaemia, hyponatraemia
giht, hiperuricemija, hiperkalcemija, hiperglikemija, hiponatrijemija Hiperkalijemija, hipomagnezijemija
a occurring at least after 1 month of treatment
ABN = apsolutni broj neutrofila a javlja se nakon najmanje 1 mjeseca liječenja
Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry mouth, gastritis
Flatulencija, abdominalna distenzija, gastroezofagealni refluks, konstipacija, Stomatitis, ulceracija u ustima, gastrointestinalno krvarenje7, podrigivanje,
There are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
Osim kod novodijagnosticirane kronične faze KML-a, ne postoje kontrolirana ispitivanja koja bi demonstrirala kliničku korist ili povećano preživljenje za ove bolesti.
(q
C.
N.E.
C/C, n.
- Each hard capsule of Imatinib Teva B.V. contains 400 mg imatinib (as mesilate).
- Jedna tvrda kapsula Imatinib Teva B.V. sadrži 400 mg imatiniba (u obliku imatinibmesilata).