natgillin/translations-raw huggingface dataset:
EU/1/12/808/001 20 x 1 film-coated tablets EU/1/12/808/002 60 film-coated tablets EU/1/12/808/003 60 x 1 film-coated tablets EU/1/12/808/004 120 film-coated tablets EU/1/12/808/005 120 x 1 film-coated tablets EU/1/12/808/006 180 x 1 film-coated tablets EU/1/12/808/007 20 x 1 film-coated tablets EU/1/12/808/008 60 film-coated tablets EU/1/12/808/009 60 x 1 film-coated tablets EU/1/12/808/010 120 film-coated tablets EU/1/12/808/011 120 x 1 film-coated tablets EU/1/12/808/012 180 x 1 film-coated tablets
EU/1/12/808/001 20 x 1 filmom obložena tableta EU/1/12/808/002 60 filmom obloženih tableta EU/1/12/808/003 60 x 1 filmom obložena tableta EU/1/12/808/004 120 filmom obloženih tableta EU/1/12/808/005 120 x 1 filmom obložena tableta EU/1/12/808/006 180 x 1 filmom obložena tableta EU/1/12/808/007 20 x 1 filmom obložena tableta EU/1/12/808/008 60 filmom obloženih tableta EU/1/12/808/009 60 x 1 filmom obložena tableta EU/1/12/808/010 120 filmom obloženih tableta EU/1/12/808/011 120 x 1 filmom obložena tableta EU/1/12/808/012 180 x 1 filmom obložena tableta
Your doctor may decide to increase the dose to 400 mg, to be taken as 1 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 1 kapsula od 400 mg jednom na dan.
• Headache or feeling tired.
glavobolja, smanjeni apetit.
EU/1/12/808/013 30 film-coated tablets EU/1/12/808/014 30 x 1 film-coated tablets EU/1/12/808/015 90 film-coated tablets EU/1/12/808/016 90 x 1 film-coated tablets EU/1/12/808/017 30 film-coated tablets EU/1/12/808/018 30 x 1 film-coated tablets EU/1/12/808/019 90 film-coated tablets EU/1/12/808/020 90 x 1 film-coated tablets
EU/1/12/808/013 30 filmom obloženih tableta EU/1/12/808/014 30 x 1 filmom obložena tableta EU/1/12/808/015 90 filmom obloženih tableta EU/1/12/808/016 90 x 1 filmom obložena tableta EU/1/12/808/017 30 filmom obloženih tableta EU/1/12/808/018 30 x 1 filmom obložena tableta EU/1/12/808/019 90 filmom obloženih tableta EU/1/12/808/020 90 x 1 filmom obložena tableta
The dose of 340 mg/m2 daily is recommended for children with chronic phase CML and advanced phase CML (not to exceed the total dose of 800 mg).
KML-a i s uznapredovalom fazom KML-a preporučuje se doza od 340 mg/m2 na dan (ne smije se prekoračiti ukupna doza od 800 mg).
Imatinib Teva 100 mg hard capsules imatinib
Teva 100 mg tvrde kapsule imatinib
How much Imatinib Teva to take
Koliko dugo uzimati Imatinib Teva
The starting dose is 400 mg, to be taken as 4 tablets once a day.
Početna doza je 400 mg, koja se uzima kao 4 tablete jednom na dan.
Imatinib Teva 100 mg film-coated tablets Each film-coated tablet contains 100 mg of imatinib (as mesilate).
Teva 100 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 100 mg imatiniba (u obliku imatinibmesilata).
Complete (Confirmed3) [95% CI]
Veliki citogenetski odgovor2 Potpuni (Potvrđeni3) [95% CI]
Contents of the pack and other information
Kako čuvati Imatinib Teva Sadržaj pakovanja i druge informacije
Imatinib Teva 100 mg film-coated tablets
Imatinib Teva 100 mg filmom obložene tablete
Imatinib Teva is indicated for the treatment of
Teva je indiciran za liječenje
BM = bone marrow, PB = peripheral blood 2 Cytogenetic response criteria:
KS = koštana srž, PK = periferna krv
In the event of recurrence of ANC < 1.0 x109/l and/or platelets < 50 x 109/l, repeat step 1 and resume imatinib at reduced dose of 260 mg/m2.
<1,0 x109/l i/ili trombociti <50 x109/l, treba ponoviti 1. korak i zatim nastaviti imatinib u smanjenoj dozi od 260 mg/m2.
MESNA (360 mg/m2/dose q3h, x 8 doses/day, IV): days 1-5 G-CSF (5 μg/kg, SC): days 6-15 or until ANC > 1500 post nadir
MESNA (360 mg/m2/doza svaka 3 sata x 8 doza/dan, i.v.): dani 1-5 G-CSF (5 μg/kg, s.c.): dani 6-15 ili do porasta ANC >1500 nakon najniže izmjerene vrijednosti i.t. metotreksat (prilagođeno dobi): SAMO dan 1
- Each hard capsule of Imatinib Teva contains 100 mg imatinib (as mesilate).
- Jedna tvrda kapsula Imatinib Teva sadrži 100 mg imatiniba (u obliku imatinibmesilata).
Imatinib Teva 400 mg film-coated tablets
Imatinib Teva 400 mg filmom obložene tablete
Imatinib Teva 400 mg film-coated tablets are available in pack sizes of 30x1or 90x1 film-coated tablets in perforated unit dose blisters.
Imatinib Teva 400 mg filmom obložene tablete dostupne su u veličinama pakiranja od 30x1ili 90x1
Imatinib Teva 400 mg hard capsules are available in pack sizes of 30x1 or 90x1 hard capsules in perforated unit dose blisters.
Teva 400 mg tvrde kapsule dostupne su u veličinama pakiranja od 30x1 ili 180x1 tvrdih kapsula u perforiranim blisterima s jediničnim dozama.
- Each hard capsule of Imatinib Teva contains 400 mg imatinib (as mesilate).
- Jedna tvrda kapsula Imatinib Teva sadrži 400 mg imatiniba (u obliku imatinibmesilata).
Imatinib Teva 400 mg film-coated tablets Each film-coated tablet contains 400 mg of imatinib (as mesilate).
Teva 400 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 400 mg imatiniba (u obliku imatinibmesilata).
The starting dose is 100 mg, to be taken as 1 capsule once a day.
Početna doza je 100 mg, koja se uzima kao jedna kapsula jednom na dan.
Chronic phase, Interferon failure
Kronična faza, novodijagnosticirani
Imatinib Teva 100 mg film-coated tablets imatinib
Teva 100 mg filmom obložene tablete imatinib
• Mouth ulcers.
suhoća usta, gastritis
At the time of the original analysis, three of the four patients with detected PDGFR gene rearrangements developed haematological response (2 CHR and 1 PHR).
PDGFR razvio se hematološki odgovor (2 CHR i 1 PHR).
When and how to take Imatinib Teva - Take Imatinib Teva with a meal.
- Imatinib Teva uzimajte uz obrok.
- Each film-coated tablet of Imatinib Teva contains 100 mg imatinib (as mesilate).
- Jedna filmom obložena tableta Imatiniba Teva sadrži 100 mg imatiniba (u obliku imatinibmesilata).
What Imatinib Teva looks like and contents of the pack Imatinib Teva 400 mg hard capsules are non transparent orange capsules with black marking 7630 on capsule body and black marking TEVA on capsule cap.
Teva 400 mg tvrde kapsule su neprozirne narančaste kapsule s crnom oznakom 7630 na tijelu kapsule i crnom oznakom TEVA na kapici kapsule.
20 out of the 50 (40%) patients in cohort 5 received haematopoietic stem cell transplant.
(40%) ih je primilo transplantirane hematopoetske matične stanice.
Dose reduction or treatment interruption for severe neutropenia and thrombocytopenia are recommended as indicated in the table below.
U slučaju teške neutropenije i trombocitopenije preporučuje se dozu smanjiti ili prekinuti liječenje,
Dark yellow to brownish orange oblong film-coated tablets with a score line on one side.
Tamnožute do smećkasto narančaste duguljaste filmom obložene tablete s urezom na jednoj strani.
- Each film-coated tablet of Imatinib Teva contains 400 mg imatinib (as mesilate).
- Jedna filmom obložena tableta Imatiniba Teva sadrži 400 mg imatiniba (u obliku imatinibmesilata).
What Imatinib Teva looks like and contents of the pack Imatinib Teva 100 mg film-coated tablets are dark yellow to brownish orange round film-coated tablets with a score line on one side.
Teva 100 mg filmom obložene tablete su tamnožute do smećkasto narančaste okrugle filmom obložene tablete s urezom na jednoj strani.
Renal failure chronic
Kronično zatajenje bubrega
Study 0110 37-month data Chronic phase, IFN failure (n=532)
neuspjeh IFN terapije (n=532)
IT Methotrexate (age-adjusted): day 1 ONLY Triple IT therapy (age-adjusted): day 8, 15
Trostruka i.t. terapija (prilagođena dobi): dan 8, 15
The starting dose is 100 mg, to be taken as 1 tablet once a day.
Početna doza je 100 mg, koja se uzima kao jedna tableta jednom na dan.
Dark yellow to brownish orange round film-coated tablets with a score line on one side.
Tamnožute do smećkasto narančaste okrugle filmom obložene tablete s urezom na jednoj strani.
What Imatinib Teva looks like and contents of the pack Imatinib Teva 100 mg hard capsules are non transparent orange capsules with black marking 7629 on capsule body and black marking TEVA on capsule cap.
Teva 100 mg tvrde kapsule su neprozirne narančaste kapsule s crnom oznakom 7629 na tijelu kapsule i crnom oznakom TEVA na kapici kapsule.
• Weight gain.
• Povećanje tjelesne težine.
Maintenance (8-week cycles)
8 ciklusa)
What Imatinib Teva looks like and contents of the pack Imatinib Teva 400 mg film-coated tablets are dark yellow to brownish orange oblong film-coated tablets with a score line on one side.
Teva 400 mg filmom obložene tablete su tamnožute do smećkasto narančaste duguljaste filmom obložene tablete s urezom na jednoj strani.
400 mg to be taken as 4 tablets once a day,
400 mg se uzima kao 1 tableta jednom na dan.
How long to take Imatinib Teva Keep taking Imatinib Teva every day for as long as your doctor tells you.
Teva nastavite uzimati svaki dan onoliko dugo koliko Vam je liječnik rekao.
Talk to your doctor before taking Imatinib Teva: - if you have or have ever had a liver, kidney or heart problem.
- ako imate, ili ste ikada imali, problema s jetrom, bubrezima ili srcem.
Imatinib Teva 400 mg film-coated tablets imatinib
Teva 400 mg filmom obložene tablete imatinib
NAME OF THE MEDICINAL PRODUCT Imatinib Teva 400 mg hard capsules imatinib
Uputa o lijeku: Informacije za bolesnika Imatinib Teva 400 mg tvrde kapsule imatinib
In the event of recurrence of ANC < 1.0 x109/l and/or platelets < 50 x 109/l, repeat step 1 and resume imatinib at reduced dose of 400 mg.
<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.
Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia, hyperglycaemia, hyponatraemia
giht, hiperuricemija, hiperkalcemija, hiperglikemija, hiponatrijemija
Daunorubicin 60 mg/m2 i.v.
200 mg/m2.
Hyper-CVAD regimen: CP 300 mg/m2 i.v.
Hiper-CVAD režim: CP 300 mg/m2 i.v. (3 h, svakih 12 h), dani 1-3;
In the event of recurrence of ANC < 1.0 x109/l and/or platelets < 50 x 109/l, repeat step 1 and resume imatinib at reduced dose of 300 mg.
<1,0 x 109/l i/ili trombociti <50 x 109/l, treba ponoviti 1. korak i zatim nastaviti imatinib u smanjenoj dozi od 300 mg.
If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Imatinib until ANC ≥ 1 x 109/l and platelets ≥ 20 x 109/l, then resume treatment at 200 mg/m2.
Ako citopenija potraje 4 tjedna i još uvijek nije povezana s leukemijom, prekinuti primjenu imatiniba sve dok ABN ne bude ≥1 x 109/i trombociti ≥20 x 109/l,
Imatinib Teva 400 mg hard capsules
Teva 400 mg tvrde kapsule
(24 h), days 1, 15; 6-MP 25 mg/m2 oral, days 1-20
MTX 500 mg/m2 i.v. (24 h), dani 1, 15; 6-MP 25 mg/m2 peroralno, dani 1-20
VCR (1.5 mg/m2/day, IV): days 1, 29 DEX (6 mg/m2/day, PO): days 1-5; 29-33 6-MP (75 mg/m2/day, PO): days 1-56 Methotrexate (20 mg/m2/week, PO): days 1, 8, 15, 22, 29, 36, 43, 50 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 = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG
Indukcija remisije DEX 10 mg/m2 peroralno, dani 6-7, 13-16; VCR 1 mg i.v., dani 7, 14; IDA 8 mg/m2 i.v. (0,5 h), dani 7, 8, 14, 15; CP 500 mg/m2 i.v.(1 h) dan 1; Ara-C 60 mg/m2 i.v., dani 22-25, 29-32
NAME OF THE MEDICINAL PRODUCT Imatinib Teva 100 mg hard capsules imatinib
Uputa o lijeku: Informacije za bolesnika Imatinib Teva 100 mg tvrde kapsule imatinib
• Use about 50 ml for each 100 mg tablet.
• Uzmite oko 50 ml za svaku tabletu od 100 mg. • Miješajte žlicom sve dok se tablete potpuno ne otope.
Cardiac disorders Uncommon
Srčani poremećaji Manje često
Imatinib Teva 100 mg film-coated tablets are available in pack sizes of 60 or 120 film-coated tablets in blisters.
Imatinib Teva 100 mg filmom obložene tablete dostupne su u veličinama pakovanja od 20x1, 60x1,
Paediatric chronic phase CML (at dose 340 mg/m2)
(doza od 340 mg/m2)
Haematological adverse reactions
Citogenetski odgovor
Hepatic failure8, hepatic necrosis Skin and subcutaneous tissue disorders Very common
Poremećaji kože i potkožnog tkiva Vrlo često
NAME OF THE MEDICINAL PRODUCT Imatinib Teva 100 mg film-coated tablets Imatinib Teva 400 mg film-coated tablets
Teva 100 mg filmom obložene tablete Imatinib Teva 400 mg filmom obložene tablete
Adult population
Starije osobe
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.
MDS/MPD-om povezanim s visokim razinama eozinofila potrebno je razmisliti o specijalističkom kardiološkom pregledu uz ehokardiogram i određivanje serumskog troponina.
NAME OF THE MEDICINAL PRODUCT Imatinib Teva 400 mg film-coated tablets imatinib
Uputa o lijeku: Informacije za bolesnika Imatinib Teva 400 mg filmom obložene tablete imatinib
monthly for 13 months; Prednisolone 200 mg oral, 5 days per month for 13 months All treatment regimens include administration of steroids for CNS prophylaxis.
VCR 2 mg i.v. mjesečno tijekom 13 mjeseci; Prednizolon 200 mg peroralno, 5 dana na mjesec tijekom 13 mjeseci
Contents of the pack and other information.
Sadržaj pakiranja i druge informacije Što Imatinib Teva sadrži
Return to chronic phase (RTC)
(RTC)
NAME OF THE MEDICINAL PRODUCT Imatinib Teva 100 mg film-coated tablets imatinib
Uputa o lijeku: Informacije za bolesnika Imatinib Teva 100 mg filmom obložene tablete imatinib
The recommended dosage of Imatinib Teva is 600 mg/day for adult patients in accelerated phase.
Za odrasle bolesnike u ubrzanoj fazi preporučena doza Imatiniba Teva iznosi is 600 mg/dan.
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
The median duration of therapy in the published literature ranged between
U vrijeme analize, medijan trajanja liječenja bio je
One large, open-label, multicentre, international randomised phase III study has been conducted in patients with newly diagnosed Ph+ CML.
Tri velika, internacionalna, otvorena, nekontrolirana klinička ispitivanja faze II provedena su u bolesnika s Ph+ KML-om u uznapredovaloj, blastičnoj ili ubrzanoj fazi bolesti, drugim Ph+
Of a panel of potential comedications (acetaminophen, aciclovir, allopurinol, amphotericin, cytarabine, erythromycin, fluconazole, hydroxyurea, norfloxacin,
Iz skupine potencijalnih lijekova za istodobnu primjenu (acetaminofen, aciklovir, alopurinol, amfotericin, citarabin, eritromicin, flukonazol, hidroksiureja, norfloksacin, penicilin V) samo su eritromicin (IC50 50 µM) i flukonazol (IC50 118 µM) pokazali da inhibiraju metabolizam imatiniba što bi moglo biti klinički značajno.
• Use about 200 ml for each 400 mg tablet.
• Uzmite oko 200 ml za svaku tabletu od 400 mg. • Miješajte žlicom sve dok se tablete potpuno ne otope.
The recommended dose of Imatinib Teva is 600 mg/day for adult patients with Ph+ ALL.
Za odrasle bolesnike s Ph+ ALL-om preporučena doza Imatiniba Teva iznosi 600 mg/dan.
• Nose bleeds.
• Modrice.
Hepatic insufficiency
Insuficijencija bubrega
The recommended dose of Imatinib Teva is 600 mg/day for adult patients in blast crisis.
Za odrasle bolesnike u blastičnoj krizi preporučena doza Imatiniba Teva iznosi 600 mg/dan.
Psychiatric disorders
Hematološke nuspojave
(24 h), day 1, and Ara-C 2 g/m2 i.v.
i.v. (24 h), dan 1, i Ara-C 2 g/m2 i.v. (svakih 12 h), dani 2-3, kroz 4 ciklusa
(1 h), days 1-3; Vincristine 1.3 mg/m2 i.v., days 1, 8, 15, 21;
Indukcijska terapija CP 1,2 g/m2 i.v. (3 h), dan 1; 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
Vincristine 2 mg i.v., days 4, 11; Doxorubicine 50 mg/m2 i.v.
Vinkristin 2 mg i.v., dani 4, 11; Doksorubicin 50 mg/m2 i.v. (24 h), dan 4; DEX 40 mg/dan na dane 1-4 i 11-14, izmjenjivano s MTX 1 g/m2
A further 162 patients with HES/CEL, reported in 35 published case reports and case series received imatinib at doses from 75 mg to 800 mg daily.
om, zabilježenih u 35 objavljenih prikaza slučajeva i serija slučajeva, primalo je imatinib u dozama od
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.): dani 1 i 15 Leucovorin (75 mg/m2 u 36. satu, i.v.; 15 mg/m2 i.v. ili p.o. svakih 6 sati x
CP 500 mg/m2 i.v.
340 mg/m2)
Of these 11 patients, 4 patients escalated up to
(Napomena, od 411 bolesnika,
The recommended dosage of Imatinib Teva is 400 mg/day for adult patients in chronic phase CML.
Za odrasle bolesnike u kroničnoj fazi KML-a preporučena doza Imatiniba Teva iznosi 400 mg/dan.
Your doctor may decide to increase the dose to 400 mg, to be taken as 1 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 1
Remission induction
Prijavljivanje nuspojava
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; Prednizon 60 mg/m2 peroralno, dani 1-7, 15-21; IDA 9 mg/m2 peroralno, dani 1-28; MTX
Methotrexate (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
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 x
• Stomach pain with feeling sick (nausea).
• Bol u trbuhu s mučninom.
Imatinib Teva is a treatment for adults and children for: - Chronic myeloid leukaemia (CML).
Teva je indiciran za liječenje • Odraslih i pedijatrijskih bolesnika s novodijagnosticiranom kroničnom mijeloičnom leukemijom
What Imatinib Teva contains - The active substance is imatinib (as mesilate).
- Djelatna tvar je imatinib (u obliku imatinibmesilata).
• Feeling sick (nausea), being sick (vomiting), diarrhoea or indigestion.
• Mučnina, povraćanje, proljev ili probavne smetnje.
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 100 mg of imatinib (as mesilate).
Jedna tvrda kapsula sadrži 100 mg imatiniba (u obliku imatinibmesilata).
(2 h, q 12 h), days 2-3 (total of 8
i.v. (24 h), dan 1, Ara-C 1 g/m2 i.v. (2 h, svakih 12 h), dani 2-3 (ukupno 8 ciklusa)
- if you experience bruising, bleeding, fever, fatigue and confusion when taking Imatinib Teva,
• Bol u zdjelici ponekad s mučninom i povraćanjem te neočekivanim krvarenjem iz rodnice,
Major response at 84 months (%) * p<0.001, Fischer's exact test ** molecular response percentages are based on available samples Haematological response criteria (all responses to be confirmed after ≥ 4 weeks): WBC < 10 x 109/l, platelet < 450 x 109/l, myelocyte+metamyelocyte < 5% in blood, no blasts and promyelocytes in blood, basophils < 20%, no extramedullary involvement Cytogenetic response criteria: complete (0% Ph+ metaphases), partial (1-35%), minor (3665%) or minimal (66-95%).
L <10 x 109/l, trombociti <450 x 109/l, mijelociti+metamijelociti <5% u krvi, nema blasta i promijelocita u krvi, bazofili < 20%, nema ekstramedularne zahvaćenosti
− if you have recently received or are about to receive a vaccine against yellow fever.
• ako ste nedavno primili ili ćete uskoro primiti cjepivo protiv žute groznice.
− infection including sepsis
• infekcija, uključujući sepsu
• Median (m)
• medijan (m)
Not known (frequency cannot be estimated from the available data)
Nepoznate učestalosti (učestalost se ne može procijeniti iz dostupnih podataka)
− thirst and increased water consumption
• žeđ i povećan unos vode
In the absence of other compatibility studies this medicinal product must not be mixed with other medicinal products.
Zbog nedostatka ispitivanja kompatibilnosti ovaj lijek se ne smije miješati s drugim lijekovima.
− if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in section 6).
• ako ste alergični na pemetreksed ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
Infection (sepsis) may be severe and could lead to death.
Infekcija (sepsa) može biti vrlo teška i može imati smrtni ishod.
Survival Time (months)
Vrijeme preživljenja (mjeseci)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 November 2015
Datum prvog odobrenja: 27. studeni 2015.
If you are unsure, ask your doctor or pharmacist if any of your medicines are NSAIDs.
Ako niste sigurni, upitajte svog liječnika ili ljekarnika je li koji od Vaših lijekova NSAIL.
• 95 % CI for median
• 95 % CI za medijan
Any diarrhoea requiring hospitalisation (irrespective of grade) or grade 3 or 4 diarrhoea
Svaki proljev koji zahtijeva hospitalizaciju (bez obzira na stupanj) ili proljev stupnja 3 ili 4
Discuss with your doctor when it is safe to restart breast-feeding after finishing your treatment.
Razgovarajte s Vašim liječnikom kada je sigurno ponovno započeti dojenje nakon dovršetka liječenja.
67801 Blansko Czech Republic Tel.: +420 516 427 311 Fax: +420 516 417 350
67801 Blansko Češka Republika Tel.: +420 516 427 311 Fax: +420 516 417 350
− increased skin pigmentation
• pojačana pigmentacija kože
− anaphylactic shock (severe allergic reaction)
• anafilaktički šok (teška alergijska reakcija)
PFS data were partially confirmed by an independent review (400/1,725 patients were randomly selected for review).
Podaci za PFS djelomično su potvrđeni neovisnom procjenom (400/1725 bolesnika bilo je nasumce odabrano za procjenu).
Based on the planned date of your infusion of Pemetrexed medac and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them.
Ovisno o planiranom datumu primjene infuzije lijeka Pemetrexed medac i/ili Vašoj bubrežnoj funkciji, liječnik Vam mora reći koje lijekove možete uzimati i kada ih možete uzimati.
• Median
• medijan
− hypernatraemia - increased sodium in blood
• hipernatremija - povećana razina natrija u krvi
Your doctor will discuss with you the potential risk of taking Pemetrexed medac during pregnancy.
Liječnik će s Vama razgovarati o mogućem riziku primjene lijeka Pemetrexed medac u trudnoći.
Pemetrexed should not be used during pregnancy unless clearly necessary, after a careful consideration of the needs of the mother and the risk for the foetus (see section 4.4).
Pemetreksed se ne smije primjenjivati tijekom trudnoće osim ako je to doista nužno i tek nakon što se pažljivo razmotre potrebe majke i rizik za fetus (vidjeti dio 4.4).
• 95 % CI for HR
• 95 % CI za HR
The European Medicines Agency has waived the obligation to submit the results of studies with Pemetrexed in all subsets of the paediatric population in the granted indications (see section 4.2).
Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka pemetreksed u svim podskupinama pedijatrijske populacije u odobrenim indikacijama (vidjeti dio 4.2).
In particular, tell your doctor if you are using medicines for pain or inflammation (swelling), such as medicines called “nonsteroidal anti-inflammatory drugs” (NSAIDs), including medicines purchased without a doctor's prescription (such as ibuprofen).
Osobito, obavijestite svog liječnika ako koristite lijekove protiv bolova ili upale (otekline), poput lijekova iz skupine takozvanih „nesteroidnih protuupalnih lijekova“ (NSAIL), uključujući lijekove koje ste nabavili bez liječničkog recepta (poput ibuprofena).
C/ Castello, nº1, Pol. Las Salinas,
C/ Castello, nº1, Pol.
− taste change
• promjena okusa
It is a white to light yellow powder.
To je bijeli do svijetložuti prašak.
Event*
Događaj*
• Response rate (%)(95 % CI) • Stable disease (%)
• stopa odgovora (%)(95 % CI) • stabilna bolest (%)
The use of Pemetrexed medac should be avoided during pregnancy.
Primjena lijeka Pemetrexed medac mora se izbjegavati tijekom trudnoće.