natgillin/translations-raw huggingface dataset:
Imatinib significantly prolonged RFS, with 75% of patients being recurrence-free at 38 months in the imatinib group vs. 20 months in the placebo group (95% CIs, [30 - non-estimable]; [14 - non- estimable], respectively); (hazard ratio = 0.398 [0.259-0.610], p<0.0001).
Imatinib je značajno produljio preživljenje bez recidiva bolesti, pri čemu je 75% bolesnika bilo bez recidiva nakon 38 mjeseci u imatinib skupini, u odnosu na 20 mjeseci u placebo skupini (95% CIs,
- Do not breast-feed during the treatment with Imatinib Teva B.V. - Patients who are concerned about their fertility while taking Imatinib Teva B.V. are advised to consult
- Bolesnicima koji su zabrinuti za svoju plodnost tijekom uzimanja Imatiniba Teva B.V. se preporučuje da se posavjetuju sa svojim liječnikom.
(see section 4.5), CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel, quinidine) or warfarin and other coumarin derivatives (see section 4.5).
pimozid, takrolimus, sirolimus, ergotamin, diergotamin, fentanil, alfentanil, terfenadin, bortezomib, docetaksel, kvinidin) ili varfarinom i drugim derivatima kumarina (vidjeti dio 4.5).
Imatinib Teva B.V. 400 mg hard capsules are non-transparent orange capsules with black marking 7630 on capsule body and black marking TEVA on capsule cap.
400 mg tvrde kapsule su neprozirne narančaste kapsule s crnom oznakom 7630 na tijelu kapsule i crnom oznakom TEVA na kapici kapsule.
(E172), talc, titanium dioxide (E171) and iron oxide red (E172))
željezovog oksida žutog (E172), talka, titanijevog dioksida (E171) i željezovog oksida crvenog
Pack sizes of 30x1 or 90x1 hard capsules in perforated unit dose blisters.
Veličine pakiranja od 30x1 ili 90x1 tvrdih kapsula u perforiranim blisterima blisterima s jediničnim
Each hard capsule contains 100 mg of imatinib (as mesilate).
Jedna tvrda kapsula sadrži 100 mg imatiniba (u obliku imatinibmesilata).
The usual starting dose is 600 mg to be taken as one tablet of 400 mg plus 2 tablets of 100 mg once a
Početna doza je 600 mg, koja se uzima kao jedna tableta od 400 mg plus 2 tablete od 100 mg jednom na dan.
Imatinib Teva B.V. is also a treatment for children with CML.
Imatinib Teva B.V. se kod djece i adolescenata također koristi za liječenje KML-a.
Imatinib Teva B.V. 100 mg hard capsules are available in pack sizes of 60 or 120 hard capsules in blisters.
100 mg tvrde kapsule dostupne su u veličinama pakiranja od 60 ili 120 tvrdih Imatinib Teva B.V.
Each hard capsule contains 400 mg of imatinib (as mesilate).
Jedna tvrda kapsula sadrži 400 mg imatiniba (u obliku imatinibmesilata).
- Each hard capsule of Imatinib Teva B.V. contains 100 mg imatinib (as mesilate).
- Jedna tvrda kapsula Imatiniba Teva B.V. sadrži 100 mg imatiniba (u obliku imatinibmesilata).
Pharmacokinetics in children
Farmakokinetika u plazmi
Imatinib Teva B.V. 100 mg film-coated tablets are dark yellow to brownish orange round film-coated tablets with a score line on one side.
100 mg filmom obložene tablete su tamnožute do smećkasto narančaste okrugle filmom obložene tablete s urezom na jednoj strani.
VCR 2 mg total dose i.v., days 1, 8, 15, 22; CP 750 mg/m2 i.v., days 1, 8;
Daunorubicin 30 mg/m2 i.v., dani 1-3, 15-16; VCR 2 mg ukupna doza i.v., dani 1, 8, 15, 22; CP 750 mg/m2 i.v., dani 1, 8;
Each film-coated tablet contains 100 mg of imatinib (as mesilate).
Jedna filmom obložena tableta sadrži 100 mg imatiniba (u obliku imatinibmesilata).
Imatinib Teva B.V. 100 mg hard capsules are non-transparent orange capsules with black marking 7629 on capsule body and black marking TEVA on capsule cap.
100 mg tvrde kapsule su neprozirne narančaste kapsule s crnom oznakom 7629 na tijelu kapsule i crnom oznakom TEVA na kapici kapsule.
Prednisolone 60 mg/m oral, days 1-5
Prednizolon 60 mg/m2 peroralno, dani 1-5
If you take more Imatinib Teva B.V. than you should If you have accidentally taken too many tablets, talk to your doctor straight away.
Ako ste zabunom uzeli previše tableta, odmah se obratite liječniku.
Palpitations, tachycardia, cardiac failure congestive3, pulmonary oedema Arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction,
Aritmija, fibrilacija atrija, srčani zastoj, infarkt miokarda, angina pektoris,
Imatinib Teva B.V. 400 mg film-coated tablets Pack sizes of 30 or 90 film-coated tablets in blisters.
400 mg filmom obložene tablete Veličine pakiranja od 30 ili 90 filmom obloženih tableta u blisterima.
mg daily.
RMP-a.
(3 h), days 1-4; Mitoxantrone 10 mg/m2 i.v.
Ara-C 1000 mg/m2/12 h i.v.(3 h), dani 1-4; Mitoksantron 10 mg/m2 i.v. dani 3-5;
Imatinib Teva B.V. 100 mg film-coated tablets are available in pack sizes of 20x1, 60x1, 120x1 or 180x1 film-coated tablets in perforated unit dose blisters.
100 mg filmom obložene tablete dostupne su u veličinama pakovanja od 20x1, 60x1, 120x1 ili 180x1 filmom obloženih tableta u perforiranim blisterima s jediničnim dozama.
See section 4.
randomizirano ispitivanje faze II.
Traces of the dissolved tablets may be left behind in the glass.
Ostatke otopljenih tableta možete
Hypertension, haematoma, subdural haematoma, peripheral coldness,
Crvenilo uz osjećaj vrućine, hemoragija Hipertenzija, hematom, subduralni hematom, periferna hladnoća, hipotenzija,
MTX 1.5 g/m2 i.v.
MTX 1,5 g/m2 i.v. (24 h), dan 1;
Methotrexate (5 g/m2 over 24 hours, IV): day 1
MTX (5 g/m2 kroz 24 sata, i.v.): dan 1
CP 500 mg/m2 i.v.
CP 500 mg/m2 i.v.(1 h) dan 1;
CP 1.2 g/m2 i.v.
CP 1,2 g/m2 i.v. (3 h), dan 1;
If your daily dose is 800 mg (2 capsules), you should take one capsule in the morning and a
Ako Vaša dnevna doza iznosi 800 mg (2 kapsule), trebate uzimati jednu kapsulu ujutro i drugu kapsulu navečer.
then resume treatment at 200 mg/m2.
200 mg/m2.
Imatinib Teva B.V. 100 mg film-coated tablets are available in pack sizes of 60 or 120 film-coated tablets in blisters.
100 mg filmom obložene tablete dostupne su u veličinama pakiranja od 60 ili 120 filmom obloženih tableta u blisterima.
In this study, 14 patients with HES/CEL were treated with 100 mg to 1,000 mg of imatinib daily.
om je liječeno imatinibom u dozi od 100 mg do 1000 mg na dan.
(1 h), days 1-3; Vincristine 1.3 mg/m2 i.v., days 1, 8, 15, 21;
Daunorubicin 60 mg/m2 i.v. (1 h), dani 1-3; Vinkristin 1,3 mg/m2 i.v., dani 1, 8, 15, 21; Prednizolon 60 mg/m2/dan peroralno
• Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with your ovaries or womb).
omaglica ili nesvjestica zbog sniženog krvnog tlaka (znakovi problema s jajnicima ili
Eyelid oedema, lacrimation increased, conjunctival haemorrhage, conjunctivitis, dry eye, blurred vision Eye irritation, eye pain, orbital oedema, scleral haemorrhage, retinal haemorrhage, blepharitis, macular oedema
Iritacija oka, bol u oku, orbitalni edem, krvarenje bjeloočnice, krvarenje mrežnice, blefaritis, makularni edem
G-CSF (5 μg/kg, SC): days 27-36 or until ANC > 1500 post nadir ARA-C (3 g/m2, q12h, IV): days 43, 44
G-CSF (5 μg/kg, s.c.): dani 27-36 ili do porasta ANC >1500 nakon
The starting dose is 400 mg, to be taken as one tablet once a day.
Početna doza je 400 mg, koja se uzima kao jedna tableta jednom na dan.
Your doctor may decide to increase the dose to 400 mg, to be taken as one capsule of 400 mg once a day, depending on how you respond to treatment.
Ovisno o tome kako reagirate na liječenje, liječnik može odlučiti povećati dozu do 400 mg, koja se uzima kao jedna kapsula jednom na dan.
Dose reduction or treatment interruption for severe neutropenia and thrombocytopenia are recommended as
U slučaju teške neutropenije i trombocitopenije preporučuje se dozu smanjiti ili prekinuti liječenje,
Your doctor may decide to increase the dose to 400 mg, to be taken as one tablet of 400 mg once a day, depending on how you respond to treatment.
Ovisno o tome kako reagirate na liječenje, liječnik može odlučiti povećati dozu do 400 mg, koja se uzima kao jedna tableta jednom na dan.
Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x 6
Leucovorin (75 mg/m2 u 36. satu, i.v.; 15 mg/m2 i.v. ili p.o. svakih 6 sati x 6 doza) iii: dani 2 i 3
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
Sindrom palmoplantarne eritrodisestezije*, lihenoidna keratoza*, lichen planus*, toksična epidermalna nekroliza*, osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (DRESS)* Poremećaji mišićno-koštanog sustava i vezivnog tkiva
NAME OF THE MEDICINAL PRODUCT Imatinib Teva B.V. 400 mg film-coated tablets
16. PODACI NA BRAILLEOVOM PISMU imatinib teva b.v. 400 mg filmom obložene tablete
- Each film-coated tablet of Imatinib Teva B.V. contains 100 mg imatinib (as mesilate).
- Jedna filmom obložena tableta Imatiniba Teva B.V. sadrži 100 mg imatiniba (u obliku
Hyperbilirubinaemia, hepatitis, jaundice
Hiperbilirubinemija, hepatitis, žutica Zatajenje jetre8, nekroza jetre
Figure 1 Kaplan-Meier estimates for primary recurrence-free survival endpoint (ITT
Kaplan-Meierova procjena preživljenja bez recidiva bolesti kao primarnog
G-CSF (5 μg/kg, SC): days 5-14 or until ANC > 1500 post nadir Triple IT therapy (age-adjusted): days 1 and 15
G-CSF (5 μg/kg, s.c.): dani 5-14 ili do porasta ANC >1500 nakon
Teva Italia S.r.l.
Teva Pharma, S.L.U.
DEX 10 mg/m2 oral, days 1-5; CP 200 mg/m2 i.v., days 3, 4, 5;
CP 200 mg/m2 i.v., dani 3, 4, 5;
The starting dose is 400 mg, to be taken as one capsule once a day.
Početna doza je 400 mg, koja se uzima kao jedna kapsula jednom na dan.
• Muscle cramps or joint, muscle or bone pain, during treatment with Imatinib Teva B.V. or after you have stopped taking Imatinib Teva B.V.
• Grčevi u mišićima ili bol u zglobovima, mišićima ili kostima, tijekom liječenja Imatinibom
The recommended dose of Imatinib Teva B.V. is 400 mg/day for adult patients with MDS/MPD.
Za odrasle bolesnike s MDS/MPD-om preporučena doza Imatiniba Teva B.V. iznosi 400 mg/dan.
Maintenance
Dojenje
The recommended dose of Imatinib Teva B.V. is 400 mg/day for the adjuvant treatment of adult patients following resection of GIST.
Za adjuvantno liječenje odraslih bolesnika nakon resekcije GIST-a preporučena doza Imatiniba Teva B.V. iznosi 400 mg/dan.
monthly for 13 months;
9 mjeseci.
The recommended dose of Imatinib Teva B.V. is 600 mg/day for adult patients with Ph+ ALL.
Za odrasle bolesnike s Ph+ ALL-om preporučena doza Imatiniba Teva B.V. iznosi 600 mg/dan.
This is because Imatinib Teva B.V.
Kako uzimati Imatinib Teva B.V.
In the event of recurrence of ANC < 1.0 x 109/l and/or platelets < 50 x 109/l, repeat step 1 and resume imatinib at reduced dose of 400 mg.
3. U slučaju da je ABN ponovno <1,0 x 109/l i/ili trombociti <50 x 109/l, treba ponoviti 1. korak i zatim nastaviti imatinib u smanjenoj dozi od 400 mg.
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.
Provedeno je jedno otvoreno, multicentrično kliničko ispitivanje faze II (studija B2225) za ispitivanje imatiniba u raznim populacijama bolesnika koji pate od životno ugrožavajućih bolesti povezanih s
Imatinib Teva B.V. 400 mg film-coated tablets are available in pack sizes of 30 or 90 film-coated tablets in blisters.
400 mg filmom obložene tablete dostupne su u veličinama pakiranja od 30 ili 90 filmom obloženih tableta u blisterima.
Imatinib Teva B.V. 100 mg hard capsules are available in pack sizes of 20x1, 60x1, 120x1 or 180x1 hard capsules in perforated unit dose blisters.
100 mg tvrde kapsule dostupne su u veličinama pakiranja od 20x1, 60x1, 120x1 ili 180x1 tvrdih kapsula u perforiranim blisterima djeljivim na jedinične doze.
• Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of muscle
• Grčevi mišića s vrućicom, crveno-smeđe obojena mokraća, bol ili slabost mišića (znakovi • Bol u zdjelici ponekad s mučninom i povraćanjem te neočekivanim krvarenjem iz rodnice,
MTX (5 g/m2 over 24 hours, IV): day 1 Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x 6
MTX (5 g/m2 kroz 24 sata, i.v.): dan 1 Leucovorin (75 mg/m2 u 36. satu, i.v.; 15 mg/m2 i.v. ili p.o. svakih 6 sati x 6 doza) iii: dani 2 i 3
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= 2
G-CSF = faktor stimulacije rasta granulocita, VP-16 = etoposid, MTX = metotreksat, i.v. = intravenski, SC = potkožno, i.t.
If any of these apply to you, tell your doctor before taking Imatinib Teva B.V.
Obratite se svom liječniku prije nego uzmete Imatinib Teva B.V.:
Imatinib Teva B.V. 100 mg film-coated tablets Each film-coated tablet contains 100 mg of imatinib (as mesilate).
100 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 100 mg imatiniba (u obliku imatinibmesilata).
ANC < 1.0 x 109/l and/or platelets < 50 x 109/l
<1,0 x109/l i/ili trombociti
Imatinib Teva B.V. 100 mg film-coated tablets
100 mg filmom obložene tablete imatinib
• Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet derived growth factor receptor (PDGFR) gene re-arrangements.
• Odraslih bolesnika s mijelodisplastičnim/mijeloproliferativnim bolestima (MDS/MPB)
(0.5 h), days 7, 8, 14, 15;
IDA 8 mg/m2 i.v. (0,5 h), dani 7, 8, 14, 15;
Clinical studies in unresectable and/or metastatic GIST
U ispitivanju kod bolesnika s inoperabilnim i/ili metastazirajućim GIST-om, u 7 (5%)
Imatinib Teva B.V. 400 mg film-coated tablets Each film-coated tablet contains 400 mg of imatinib (as mesilate).
400 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 400 mg imatiniba (u obliku imatinibmesilata).
Methotrexate (5 g/m2 over 24 hours, IV): days 1 and 15 Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x 6
Metotreksat (5 g/m2 kroz 24 sata, i.v.): dan 1 Leucovorin (75 mg/m2 u 36. satu, i.v.; 15 mg/m2 i.v. ili p.o. svakih 6 sati
Imatinib Teva B.V. 400 mg film-coated tablets
400 mg filmom obložene tablete Imatinib
CPM (250 mg/m2/dose q12h x 4 doses, iv): Days 3 and 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
• Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (eg.
• Mučnina, nedostatak zraka, nepravilni otkucaji srca, zamućenje mokraće, umor i/ili osjećaj nelagode u zglobovima udruženi s poremećenim nalazima laboratorijskih pretraga (npr. visoke razine kalija, mokraćne kiseline i kalcija te niske razine fosfora u krvi).
Hyper-CVAD regimen: CP 300 mg/m2 i.v.
Indukcijsko-konsolidacijska terapija Hiper-CVAD režim: CP 300 mg/m2 i.v. (3 h, svakih 12 h), dani 1-3;
Triple IT therapy (age-adjusted): days 1 and 22 VP-16 (100 mg/m2/day, IV): days 22-26
Metotreksat (20 mg/m2/tjedan, p.o.): dani 8, 15, 22 VP-16 (100 mg/m2, i.v.): dani 29-33
Therefore, caution should be exercised in patients with cardiac
Zbog toga se u bolesnika s poremećenom srčanom funkcijom mora postupati s oprezom.
Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis,
melena, ezofagitis, ascites, želučani ulkus, hematemeza, heilitis, disfagija,
Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia,
Neutropenija, trombocitopenija, anemija Pancitopenija, febrilna neutropenija Trombocitemija, limfopenija, depresija koštane srži, eozinofilija,
Prephase
Kod prvih
Absorption
Plodnost
This will help protect you from stomach problems when
To će Vam pomoći u zaštiti od želučanih problema prilikom uzimanja Imatiniba Teva B.V.
2/day, PO): days 1-7 and 15-21
2/dan, i.v.): dani 1, 8 i 15
Ara-C 75 mg/m2 i.v.
Ara-C 75 mg/m2 i.v. (1 h), dani 1-5;
A major response combines both complete and partial responses: complete (0% Ph+ metaphases), partial (1-35%)
Veliki odgovor je kombinacija potpunih i djelomičnih odgovora: potpuni (0% Ph+ metafaza), 3 Potpuni citogenetski odgovor potvrđen drugom citogenetskom procjenom koštane srži koja je provedena najmanje jedan mjesec nakon početnog ispitivanja koštane srži.
Etoposide 250 mg/m2 i.v.
Etopozid 250 mg/m2 i.v. (1 h) dani 4-5;
Tumour lysis syndrome
Mijeloična blastična kriza
Vincristine 2 mg i.v., days 4, 11; Doxorubicine 50 mg/m2 i.v.
Vinkristin 2 mg i.v., dani 4, 11;
NAME OF THE MEDICINAL PRODUCT Imatinib Teva B.V. 100 mg hard capsules Imatinib Teva B.V. 400 mg hard capsules
100 mg tvrde kapsule Imatinib Teva B.V.
Imatinib Teva B.V. 400 mg hard capsules are available in pack sizes of 30x1 or 90x1 hard capsules in perforated unit dose blisters.
400 mg tvrde kapsule dostupne su u veličinama pakiranja od 30x1 ili 180x1 tvrdih kapsula u perforiranim blisterima s jediničnim dozama.
DEX 10 mg/m2 oral, days 1-5; CP 200 mg/m2 i.v., days 3-5;
CP 200 mg/m2 i.v., dani 3-5;
At the time of the original analysis, three of the four patients with detected
U tom kliničkom ispitivanju, 14 bolesnika s HES/KEL
Colitis, ileus, inflammatory bowel disease
Kolitis, ileus, upalna bolest crijeva Ileus/intestinalna opstrukcija*, gastrointestinalna perforacija*,
NAME OF THE MEDICINAL PRODUCT Imatinib Teva B.V. 100 mg film-coated tablets Imatinib Teva B.V. 400 mg film-coated tablets
100 mg filmom obložene tablete Imatinib Teva B.V.
What Imatinib Teva B.V. looks like and contents of the pack Imatinib Teva B.V. 400 mg film-coated tablets are dark yellow to brownish orange oblong film-coated tablets with a score line on one side.
400 mg filmom obložene tablete su tamnožute do smećkasto narančaste okrugle filmom obložene tablete s urezom na jednoj strani.
The recommended dose of Imatinib Teva B.V. is 600 mg/day for adult patients in blast crisis.
Za odrasle bolesnike u blastičnoj krizi preporučena doza Imatiniba Teva B.V. iznosi 600 mg/dan.
The recommended dose of Imatinib Teva B.V. is 100 mg/day for adult patients with HES/CEL.
Za odrasle bolesnike s HES/KEL-om preporučena doza Imatiniba Teva B.V. iznosi 100 mg/dan.
(24 h), days 1, 15; 6-MP 25 mg/m2 oral, days 1-20 Consolidation therapy II, IV Ara-C 75 mg/m2 i.v.
Konsolidacijska terapija I, III, V MTX 500 mg/m2 i.v. (24 h), dani 1, 15; 6-MP 25 mg/m2 peroralno, dani 1-20
What you need to know before you take Imatinib Teva B.V. Imatinib Teva B.V. will only be prescribed to you by a doctor with experience in medicines to treat blood
Što je Imatinib Teva B.V. i za što se koristi Imatinib Teva B.V. je lijek koji sadrži djelatnu tvar zvanu imatinib.
100 vs. 100 97.8 vs. 100
64,0 80,7 vs. 46,6 NP
Teva Nederland B.V. Tel: +31 800 0228 400
Pliva Hrvatska d.o.o. Tel: +385 1 37 20 000
G-CSF (5 μg/kg, SC): days 4-13 or until ANC > 1500 post nadir VCR (1.5 mg/m2/day, IV): days 1, 8, and 15
ARA-C (3 g/m2/doza svakih 12 sati x 4, i.v.): dani 2 i 3 G-CSF (5 μg/kg, s.c.): dani 4-13 ili do porasta ANC >1500 nakon
Insomnia
Imatinib Teva
Posology for CML in children
Doziranje za KML u odraslih bolesnika
Bilirubin
Nuspojave
RFS rates (%) 12 month 24 month Imatinib vs placebo
-- (1) Imatinib 12 mj.:
Imatinib Teva B.V. 400 mg film-coated tablets are available in pack sizes of 30x1or 90x1 film-coated tablets
400 mg filmom obložene tablete dostupne su u veličinama pakiranja od 30x1 ili 90x1 filmom obloženih tableta u perforiranim blisterima s jediničnim dozama.
Package leaflet: Information for the patient Imatinib Teva B.V. 400 mg film-coated tablets Imatinib
Uputa o lijeku: Informacije za bolesnika Imatinib Teva B.V.
GIST.
Norge
Confusional state Nervous system disorders Very common:
Poremećaji reproduktivnog sustava i dojki Manje često
See section 4
Studija ADE04
• Anaemia (low number of red blood cells).
• anemija (nizak broj crvenih krvnih stanica).
• Feeling weak or lack of energy (asthenia).
• slabost ili nedostatak energije (astenija).
You will take Exviera for either 12 or 24 weeks.
Lijek Exviera uzimat ćete tijekom 12 ili 24 tjedna.
• More than 6 hours until your next dose - take the missed dose with food as soon as possible.
• više od 6 sati do sljedeće doze - uzmite propuštenu dozu s hranom što je prije moguće.
Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: Description
Nositelj odobrenja dužan je, unutar navedenog vremenskog roka, provesti niže navedene mjere: Opis
What Exviera is and what it is used for 2.
Što je Exviera i za što se koristi 2.
Hepatitis B Virus Reactivation)
Reaktivacija virusa hepatitisa B
Pharmacotherapeutic group: Antivirals for systemic use; direct-acting antivirals, ATC code: J05AX16 Mechanism of action
Farmakoterapijska skupina: Antivirotici za sistemsku uporabu; antivirotici koji djeluju izravno, ATK oznaka: J05AX16
Table 15 shows SVR rates for these subjects.
U Tablici 15 prikazane su stope SVR-a za te ispitanike.
There are some medicines you must not take with Exviera - see the previous table “Medicines you must not take with Exviera”.
Postoje određeni lijekovi koje ne smijete uzimati s lijekom Exviera - pogledajte prethodnu tablicu 'Lijekovi koje ne smijete uzimati s lijekom Exviera'.
NS5A M28T M28V
NS5A M28T M28Ve
The recommended dose of dasabuvir is 250 mg (one tablet) twice daily (morning and evening).
Preporučena doza dasabuvira je 250 mg (jedna tableta) dvaput na dan (ujutro i navečer).
Changes for dasabuvir and ombitasvir, paritaprevir are the same as shown for paracetamol above
Promjene za dasabuvir i ombitasvir, paritaprevir su iste kao što je prikazano iznad za paracetamol
5 of 6 subjects with compensated cirrhosis in each arm achieved SVR12.
Pet od 6 ispitanika s kompenziranom cirozom u svakoj skupini ostvarilo je SVR12.
In order to evaluate the recurrence of hepatocellular carcinoma associated with Exviera, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Kako bi se procijenilo ponovno pojavljivanje hepatocelularnog karcinoma povezanog s primjenom lijeka Exviera, nositelj odobrenja mora provesti i dostaviti rezultate prospektivnog ispitivanja sigurnosti, koristeći podatake koji proizlaze iz kohorte dobro definirane skupine bolesnika, na temelju dogovorenog protokola.
Exviera film-coated tablets are supplied in PVC/PE/PCTFE aluminium foil blister packs.
Exviera filmom obložene tablete dostupne su u blister pakiranjima od PVC/PE/PCTFE aluminijske folije.
67061 Ludwigshafen GERMANY
67061 Ludwigshafen
Q30R
Q30Re
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Bolesnici s rijetkim nasljednim problemima nepodnošenja galaktoze, nedostatka Lapp laktaze ili malapsorpcije glukoze i galaktoze ne smiju uzimati ovaj lijek.
Drug interaction studies have only been performed in adults.
Pedijatrijska populacija Ispitivanja interakcija provedena su samo u odraslih.
Exviera must not be administered as monotherapy.
Exviera se ne smije uzimati kao monoterapija.
If more than 6 hours have passed since Exviera is usually taken, the missed dose should NOT be taken and the patient should take the next dose per the usual dosing schedule.
Ako je prošlo više od 6 sati od uobičajenog vremena uzimanja doze lijeka Exviera, propuštena doza se NE smije uzeti nego bolesnik mora nastaviti sa sljedećom dozom prema uobičajenom rasporedu doziranja.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/983/001
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/983/001
It is very important that you also read the package leaflets for the other antiviral medicines that you take with Exviera.
Vrlo je važno da pročitate i Upute o lijeku za druge antivirusne lijekove koje uzimate s lijekom Exviera.