natgillin/translations-raw huggingface dataset:
1200 to 1600 mg (duration varying between 1 to 10 days): Nausea, vomiting, diarrhoea, rash, erythema, oedema, swelling, fatigue, muscle spasms, thrombocytopenia, pancytopenia, abdominal pain, headache, decreased appetite.
1200 do 1600 mg (trajanje je variralo između jednog i 10 dana): mučnina, povraćanje, proljev, osip,
Active substances that may have their plasma concentration altered by imatinib:
Djelatne tvari čije bi koncentracije u plazmi imatinib mogao promijeniti:
Posology for DFSP The recommended dose of imatinib is 800 mg/day for adult patients with DFSP.
Doziranje za DFSP Za odrasle bolesnike s DFSP-om preporučena doza imatiniba iznosi 800 mg/dan.
Five (5) patients with DFSP and PDGFR gene re-arrangements were reported in 3 publications.
U 3 publikacije zabilježeno je pet (5) bolesnika s DFSP-om i preraspodjelom PDGFR gena.
There was no change in the kinetics of imatinib on repeated dosing, and accumulation was 1.5-2.5-fold at steady state when dosed once daily.
Nije bilo promjene kinetike imatiniba nakon ponovljenog doziranja, a akumulacija je bila
- Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel problems).
- mučnina s proljevom i povraćanjem, bol u trbuhu ili vrućica (znakovi crijevnih problema).
Renal failure chronic
Pedijatrijska kronična faza
If your daily dose is 800 mg (2 capsules), you should take one capsule in the morning and a second capsule in the evening.
Ako Vaša dnevna doza iznosi 800 mg (2 kapsule), trebate uzimati jednu kapsulu ujutro i drugu kapsulu navečer.
When the response rate is calculated from patients with at least one valid assessment, the response rate for CHR, CCyR and MR was 20/22 (90.9%), 9/9 (100%) and 11/17 (64.7%), respectively.
20/22 (90,9%), 9/9 (100%) odnosno 11/17 (64,7%).
Organ function impairment
Oštećenje funkcije organa
Oval-shape, 18.6x6.6 mm, biconvex dark yellow to brownish film-coated tablet, embossed with company logo on one side and “37” with score line on the other side.
Ovalna, bikonveksna filmom obložena tableta, veličine 18,6x6,6 mm, tamnožute do smeđe boje s utisnutim logom tvrtke na jednoj strani i „37“ s razdjelnom crtom na drugoj strani.
The same publication reported long term follow-up data from 12 MDS/MPD patients with PDGFR gene rearrangements (5 patients from study B2225).
Ista publikacija je objavila i podatke dugotrajnog praćenja od 12 MDS/MPD bolesnika s preraspodjelom
Induction therapy I DEX 10 mg/m2 oral, days 1-5; VCR 2 mg i.v., days 6, 13, 20; daunorubicin 45 mg/m2 i.v., days 6-7, 13-14
I DEX 10 mg/m2 peroralno, dani 1-5; VCR 2 mg i.v., dani 6, 13, 20; daunorubicin 45 mg/m2 i.v., dani 6-7, 13-14
At the time of analysis, the treatment duration was a median of 47 months (24 days - 60 months).
47 mjeseci (24 dana - 60 mjeseci).
Hard capsule with light yellow cap and light yellow body imprinted with 50 mg in black ink.
Tvrda kapsula sa svijetložutom kapicom i svijetložutim tijelom sa crnom tintom otisnutim natpisom 50 mg.
Hard capsule of size 00 with orange opaque colour cap and body imprinted with “400 mg” in black ink.
Tvrda kapsula veličine 00 s narančastom i neprozirnom kapicom i tijelom s oznakom „400 mg“
Migraine, somnolence, syncope, peripheral neuropathy, memory impairment, sciatica, restless leg syndrome, tremor, cerebral haemorrhage
Migrena, pospanost, sinkopa, periferna neuropatija, poremećaj pamćenja,
See section 4.
PRILOG II.
aANC < 0.5 x 109/L and/or platelets < 10 x 109/L
aABN <0,5 x 109/l i/ili trombociti <10 x 109/l
Mild
Blagi
Fluid retention and oedema, fatigue
Retencija tekućine i edem, umor
These patients received imatinib for a median of 47 months (range 24 days - 60 months).
Ti su bolesnici primali imatinib za medijan od 47 mjeseci
Imatinib Actavis 50 mg hard capsules Imatinib Actavis 100 mg hard capsules Imatinib Actavis 400 mg hard capsules
Imatinib Actavis 50 mg tvrde kapsule Imatinib Actavis 100 mg tvrde kapsule Imatinib Actavis 400 mg tvrde kapsule
Imatinib Actavis 400 mg film-coated tablets EU/1/13/825/015
Imatinib Actavis 400 mg filmom obložene tablete EU/1/13/825/015
ANC < 1.0 x 109/L and/or platelets < 50 x 109/L
ABN <1,0 x 109/l i/ili trombociti <50 x 109/l
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/KELom i u bolesnika s MDS/MPD-om povezanim s visokim razinama eozinofila potrebno je razmisliti o pregledu kod specijaliste kardiologa, obavljanje ehokardiograma i određivanje serumskog troponina.
CPM (300 mg/m2/day, IV): days 22-26
CPM (300 mg/m2/dan, i.v.): dani 22-26
Imatinib Actavis 100 mg film-coated tablets EU/1/13/825/008
Imatinib Actavis 100 mg filmom obložene tablete EU/1/13/825/008
The recommended starting dose is 600 mg to be taken as one tablet of 400 mg plus 2 tablets of 100 mg once a day.
Preporučena početna doza je 600 mg, koja se uzima kao jedna tableta od 400 mg i 2 tablete od 100 mg jednom na dan.
Lecithin (soya)
Sojin lecitin
- Chronic renal failure.
- kronično zatajanje bubrega.
Posology for HES/CEL The recommended dose of imatinib is 100 mg/day for adult patients with HES/CEL.
Za odrasle bolesnike s HES/KEL-om preporučena doza imatiniba iznosi 100 mg/dan.
Imatinib Actavis 100 mg film-coated tablets Imatinib Actavis 400 mg film-coated tablets
Imatinib Actavis 100 mg filmom obložene tablete Imatinib Actavis 400 mg filmom obložene tablete
Imatinib Actavis 400 mg hard capsules Each hard capsule contains 400 mg imatinib (as mesilate).
Imatinib Actavis 400 mg tvrde kapsule Svaka tvrda kapsula sadrži 400 mg imatiniba (u obliku imatinibmesilata).
If your daily dose is 800 mg (16 capsules), you should take 8 capsules in the morning and 8 capsules in the evening.
Ako Vaša dnevna doza iznosi 800 mg (16 kapsula), trebate uzimati 8 kapsula ujutro i 8 kapsula navečer.
of the dose was recovered within 7 days in faeces (68% of dose) and urine (13% of dose).
Na temelju izlučivanja spoja(eva) nakon oralne, pomoću 14C- označene doze imatiniba, oko 81% doze izlučilo se u roku od 7 dana u stolici (68% doze) i mokraći (13% doze).
Hard capsule of size 3 with light yellow cap and light yellow body imprinted with “50 mg” in black ink.
Tvrda kapsula veličine 3 sa svijetložutom kapicom i svijetložutim tijelom s oznakom "50 mg"
Iron oxide yellow (E172) Titanium dioxide (E171) Iron oxide red (E172) Lecithin (soya) (E322) Xanthan gum (E415)
Ovojnica tablete poli(vinilni alkohol), djelomično hidrolizirani talk željezov oksid, žuti (E172) titanijev dioksid (E171) željezov oksid, crveni (E172) sojin lecitin (E322) ksantanska guma (E415)
9 Musculoskeletal pain during treatment with imatinib or after discontinuation has been observed in post-marketing.
9 Nakon stavljanja lijeka u promet primijećena je mišićno-koštana bol koja se javlja tijekom liječenja imatinibom, kao i nakon prekida liječenja.
- 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 maternicom).
This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‘sodium-free'.
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po tvrdoj kapsuli, tj. zanemarive količine natrija.
Imatinib Actavis 400 mg tablets imatinib
Imatinib Actavis 400 mg tablete imatinib
Imatinib Actavis 50 mg hard capsules Each hard capsule contains 50 mg imatinib (as mesilate).
Imatinib Actavis 50 mg tvrde kapsule Svaka tvrda kapsula sadrži 50 mg imatiniba (u obliku imatinibmesilata).
Remission induction DEX 10 mg/m2 oral, days 6-7, 13-16; VCR 1 mg i.v., days 7, 14; IDA 8 mg/m2 i.v.
Indukcija remisije DEX 10 mg/m2 peroralno, dani 6-7, 13-16; VCR 1 mg i.v., dani 7, 14; IDA
This medicinal product contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‘sodium-free'.
Natrij Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po tvrdoj kapsuli, tj. zanemarive količine natrija.
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 260 mg/m2.
<1,0 x 109/l i/ili trombociti <50 x 109/l, treba ponoviti 1. korak i nastaviti primjenu imatiniba u smanjenoj dozi od 260 mg/m2
Imatinib Actavis 50 mg hard capsules EU/1/13/825/001
Imatinib Actavis 50 mg tvrde kapsule EU/1/13/825/001
How to store Imatinib Actavis
Kako čuvati Imatinib Actavis
Hard capsule with light orange cap and light orange body imprinted with 100 mg in black ink.
Tvrda kapsula sa svijetlonarančastom kapicom i svijetlonarančastim tijelom sa crnom tintom otisnutim natpisom 100 mg.
Ear and labyrinth disorders
Poremećaji uha i labirinta Manje često
The starting dose is 100 mg, to be taken as one capsule of 100 mg once a day.
Početna doza je 100 mg, koja se uzima kao jedna kapsula od 100 mg jednom na dan.
Imatinib Actavis 400 mg hard capsules EU/1/13/825/020
Imatinib Actavis 400 mg tvrde kapsule EU/1/13/825/020
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 srednju vrijednost Cmax i AUC simvastatina (CYP3A4 supstrat) za 2, odnosno
Stop imatinib until ANC ≥ 1.5 x 109/L and platelets ≥ 75 x 10
Ukinuti imatinib sve dok ABN ne bude ≥1,5 x 109/l i trombociti ≥75 x
The starting dose is 400 mg to be taken as 4 capsules once a day.
Početna doza je 400 mg, koja se uzima kao 4 kapsule jednom na dan.
Package leaflet: Information for the user Imatinib Actavis 100 mg film-coated tablets imatinib
Uputa o lijeku: Informacije za bolesnika Imatinib Actavis 100 mg filmom obložene tablete imatinib
Headache2
Glavobolja2
DEX 10 mg/m2 oral, days 1-5; CP 200 mg/m2 i.v., days 3, 4, 5; MTX 12 mg intrathecal, day 1
DEX 10 mg/m2 peroralno, dani 1-5; CP 200 mg/m2 i.v., dani 3, 4, 5; MTX 12 mg intratekalno, dan 1
Joint and muscle stiffness
Ukočenost zglobova i mišića
LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS
PRILOG I SAŽETAK OPISA SVOJSTAVA LIJEKA
Reproductive system and breast disorders
Poremećaji reproduktivnog sustava i dojki Manje često
Package leaflet: Information for the user Imatinib Actavis 400 mg film-coated tablets imatinib
Uputa o lijeku: Informacije za bolesnika Imatinib Actavis 400 mg filmom obložene tablete imatinib
The starting dose is 100 mg, to be taken as one tablet of 100 mg once a day.
Početna doza je 100 mg, koja se uzima kao jedna tableta od 100 mg jednom na dan.
If your daily dose is 800 mg (8 capsules), you should take 4 capsules in the morning and 4 capsules in the evening.
Ako Vaša dnevna doza iznosi 800 mg (8 kapsula), trebate uzimati 4 kapsule ujutro i 4 kapsule navečer.
Imatinib Actavis 100 mg tablets imatinib
Imatinib Actavis 100 mg tablete imatinib
The starting dose is 100 mg, to be taken as 2 capsules once a day.
Početna doza je 100 mg, koja se uzima kao 2 kapsule jednom na dan.
- Mouth ulcers.
- čirevi u ustima.
DFSP (at dose 800 mg) ANC < 1.0 x 109/L and/or platelets < 50 x 109/L
KML-a i blastična kriza (početna doza 340 mg/m aABN <0,5 x 109/l i/ili trombociti <10 x 109/l
and/or platelets < 10 x 109/L
9/l i/ili trombociti <50 x 109/l
Stop imatinib until ANC ≥ 1.5 x 109/L and platelets ≥ 75 x 109/L.
Ukinuti imatinib sve dok ABN ne bude ≥1,5 x 109/l i/ili trombociti ≥75 x 109/l
DEX 10 mg/m2 oral, days 1-5; CP 200 mg/m2 i.v., days 3-5; MTX 15 mg intrathecal, day 1
DEX 10 mg/m2 peroralno, dani 1-5; CP 200 mg/m2 i.v., dani 3-5; MTX 15 mg intratekalno, dan 1
- Numb or cold toes and fingers (signs of Raynaud's syndrome).
- utrnuli ili hladni prsti na nogama i rukama (znakovi Raynaudovog sindroma). - iznenadno oticanje i crvenilo kože (znakovi kožne infekcije zvane celulitis). - oslabljen sluh.
If you are unable to swallow the tablets, you can dissolve them in a glass of still or mineral water or apple juice: - Use about 50 ml for each 100 mg tablet.
Ako ne možete progutati tabletu, možete je otopiti u čaši obične ili mineralne vode ili soka od jabuke:
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.
Concomitant use of imatinib and medicinal products that induce CYP3A4 (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to imatinib, potentially increasing the risk of therapeutic failure.
Istodobna primjena imatiniba i lijekova koji induciraju CYP3A4 (npr. deksametazon, fenitoin, karbamazepin, rifampicin, fenobarbital ili Hypericum perforatum, poznat također kao gospina trava)
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 od 400 mg jednom na dan.
Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia, hyperglycaemia, hyponatraemia
Hipokalijemija, povećan apetit, hipofosfatemija, smanjen apetit, dehidracija,
Round, 9.2 mm in diameter, biconvex dark yellow to brownish film-coated tablet, embossed with company logo on one side and “36” with score line on the other side.
Okrugla, bikonveksna filmom obložena tableta promjera 9,2 mm, tamnožute do smeđe boje s utisnutim logom tvrtke na jednoj strani i „36“ s razdjelnom crtom na drugoj strani.
The usual starting dose is 600 mg to be taken as 12 capsules once a day.
Uobičajena početna doza je 600 mg, koja se uzima kao 12 kapsula jednom na dan.
Imatinib Actavis 100 mg hard capsules EU/1/13/825/003
Imatinib Actavis 100 mg tvrde kapsule EU/1/13/825/003
Imatinib Actavis 50 mg capsules imatinib
Imatinib Actavis 50 mg kapsule imatinib
- if you experience bruising, bleeding, fever, fatigue and confusion when taking Imatinib Actavis, contact your doctor.
Prije početka liječenja liječnik će pažljivo pregledati bolesnike radi utvrđivanja eventualnih znakova te infekcije. ako dobijete modrice, krvarenje, vrućicu, umor i smetenost prilikom uzimanja Imatiniba Actavis, kontaktirajte liječnika.
- Feeling light-headed, dizzy or fainting (signs of low blood pressure).
- osjećaj da Vam se vrti u glavi, omaglica ili nesvjestica (znakovi sniženog krvnog tlaka).
Blood and lymphatic system disorders
Anafilaktički šok* Poremećaji krvi i limfnog sustava Vrlo često
Imatinib Actavis 100 mg hard capsules Each hard capsule contains 100 mg imatinib (as mesilate).
Imatinib Actavis 100 mg tvrde kapsule Svaka tvrda kapsula sadrži 100 mg imatiniba (u obliku imatinibmesilata).
The starting dose is 100 mg, to be taken as one tablet once a day.
Početna doza je 100 mg, koja se uzima kao jedna tableta jednom na dan.
(1 h), days 1-5; VM26 60 mg/m2 i.v.
Ara-C 75 mg/m2 i.v. (1 h), dani 1-5; VM26 60 mg/m2 i.v. (1 h), dani 1-5
(1 h), days 28-31, 35-38, 42-45; 6-MP 60 mg/m2 oral, days 26-46
CP 1 g/m2 i.v. (1 h), dani 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
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 od 400 mg jednom na dan.
VCR (1.5 mg/m2/day, IV): days 1, 8 and 15
VCR (1,5 mg/m2/dan, i.v.): dani 1, 8 i 15
VCR (1.5 mg/m2/day, IV): days 1, 8, and 15
VCR (1,5 mg/m2/dan, i.v.): dani 1, 8, i 15
Clinical studies in chronic myeloid leukaemia
Klinička ispitivanja kod HES/KEL-a
As cardiac adverse events have been reported uncommonly with imatinib, a careful assessment of the benefit/risk of imatinib therapy should be considered in the HES/CEL population before treatment initiation.
Budući da su srčane nuspojave zabilježene manje često uz imatinib, prije početka liječenja u HES/KEL
If laboratory or clinical findings associated with TMA occur in a patient receiving Imatinib Actavis, treatment should be discontinued and thorough evaluation for TMA, including ADAMTS13 activity and antiADAMTS13-antibody determination, should be completed.
Ako se laboratorijski ili klinički nalaz povezan s TMA-om javi u bolesnika koji prima Imatinib Actavis,
Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people): - Chest pain, irregular heart rhythm (signs of heart problems).
Manje česte (mogu se javiti u do 1 na 100 osoba) ili rijetke (mogu se javiti u do 1 na 1000 osoba):
Each film-coated tablet contains 100 mg of imatinib (as mesilate).
Svaka filmom obložena tableta sadrži 100 mg imatiniba (u obliku imatinibmesilata).
Imatinib Actavis 400 mg capsules imatinib
Imatinib Actavis 400 mg kapsule imatinib
The starting dose is 600 mg to be taken as 6 tablets once a day.
Početna doza je 600 mg, koja se uzima kao 6 tableta jednom na dan.
Each film-coated tablet contains 400 mg of imatinib (as mesilate).
Svaka filmom obložena tableta sadrži 400 mg imatiniba (u obliku imatinibmesilata).
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
The dose is 800 mg per day (8 tablets), to be taken as 4 tablets in the morning and 4 tablets in the evening.
Ako se liječite zbog DFSP-a: Doza je 800 mg na dan (8 tableta), koja se uzima kao 4 tablete ujutro i 4 tablete navečer.
The starting dose is 100 mg, to be taken as one capsule once a day.
Početna doza je 100 mg, koja se uzima kao jedna kapsula jednom na dan.
VCR (1.5 mg/m2/day, IV): days 1, 29
VCR (1,5 mg/m2/dan, i.v.): dani 1, 29
- adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
- odraslih bolesnika s recidivirajućim ili refraktornim Ph+ ALL-om u obliku monoterapije. - odraslih bolesnika s mijelodisplastičnim/mijeloproliferativnim bolestima (MDS/MPD)
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.
Imatinib Actavis 100 mg capsules imatinib
Imatinib Actavis 100 mg kapsule imatinib
Package leaflet: Information for the user Imatinib Actavis 50 mg hard capsules imatinib
Uputa o lijeku: Informacije za bolesnika Imatinib Actavis 50 mg tvrde kapsule imatinib
respectively.
vrijednosti.
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 najniže izmjerene vrijednosti
- Itching.
GIST-om.
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.
Inductionconsolidation therapy
Indukcijskokonsolidacijska terapija
Package leaflet: Information for the user Imatinib Actavis 400 mg hard capsules imatinib
Uputa o lijeku: Informacije za bolesnika Imatinib Actavis 400 mg tvrde kapsule imatinib
(24 h), day 1, and Ara-C 2 g/m2 i.v.
(24 h), dan 1, i Ara-C 2 g/m2 i.v. (svakih 12 h), dani 2-3, kroz 4 ciklusa
Imatinib Actavis 100 mg film-coated tablets
Imatinib Actavis 100 mg filmom obložene tablete
The starting dose is 600 mg to be taken as 6 capsules once a day.
Početna doza je 600 mg, koja se uzima kao 6 kapsula jednom na dan.
Printing ink: shellac, black iron oxide (E172), propylene glycol, ammonia solution, potassium hydroxide.
crni željezov oksid (E172), propilenglikol, otopina amonijaka, kalijev hidroksid.
and platelets ≥ 75 x 109/L.
≥1,5 x 109/l i trombociti ≥75 x 109/l.
Printing ink
otisnutom crnom tintom.
Oval-shape, biconvex dark yellow to brownish film-coated tablet, embossed with company logo on one side and “37” with score line on the other side.
Ovalna, bikonveksna filmom obložena tableta, tamnožute do smeđe boje s utisnutim logom tvrtke na jednoj i „37“ s razdjelnom crtom na drugoj strani.
Round, biconvex dark yellow to brownish film-coated tablet, embossed with company logo on one side and “36” with score line on the other side.
Okrugla, bikonveksna filmom obložena tableta, tamnožute do smeđe boje s utisnutim logom tvrtke na jednoj i „36“ s razdjelnom crtom na drugoj strani.
Actavis Ltd. Tel: +356 21693533
Tel: +356 21693533
Each capsule contains 50 mg imatinib (as mesilate).
Svaka kapsula sadrži 50 mg imatiniba (u obliku imatinibmesilata).
Capsule shell: hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
Ovojnica kapsule: hipromeloza, titanijev dioksid (E171), žuti željezov oksid (E172), crveni željezov oksid (E172), crni željezov oksid (E172).
- 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).
Package leaflet: Information for the user Imatinib Actavis 100 mg hard capsules imatinib
Uputa o lijeku: Informacije za bolesnika Imatinib Actavis 100 mg tvrde kapsule imatinib
The dose is 800 mg per day (16 capsules), to be taken as 8 capsules in the morning and 8 capsules in the evening.
Ako se liječite zbog DFSP-a: Doza je 800 mg na dan (16 kapsula), koja se uzima kao 8 kapsula ujutro i 8 kapsula navečer.
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 doses)iii:
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
Imatinib Actavis 50 mg hard capsules
Imatinib Actavis 50 mg tvrde kapsule
Each capsule contains 400 mg imatinib (as mesilate).
Svaka kapsula sadrži 400 mg imatiniba (u obliku imatinibmesilata).
Moderate
pankreatitis
Imatinib Actavis 100 mg film-coated tablets Pack containing either 10, 20, 30, 60, 90, 120 or 180 film-coated tablets
Pakiranje sadrži 10, 20, 30, 60, 90, 120 ili 180 filmom obloženih tableta Imatinib Actavis 400 mg filmom obložene tablete
Hepatic function should be carefully monitored in circumstances where imatinib is combined with chemotherapy regimens also known to be associated with hepatic dysfunction (see sections 4.5 and 4.8).
U slučajevima kada se imatinib kombinira s režimima kemoterapije za koje je poznato da su povezani s poremećajem funkcije jetre potrebno je pažljivo praćenje jetrene funkcije (vidjeti dijelove
Each hard capsule contains 50 mg of imatinib (as mesilate).
Svaka tvrda kapsula sadrži 50 mg imatiniba (u obliku imatinibmesilata).
The dose is 800 mg per day (8 capsules), to be taken as 4 capsules in the morning and 4 capsules in the evening.
Ako se liječite zbog DFSP-a: Doza je 800 mg na dan (8 kapsula), koja se uzima kao 4 kapsule ujutro i 4 kapsule navečer.
Capsule shell: hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
Ovojnica kapsule: hipromeloza, titanijev dioksid (E171), žuti željezov oksid (E172), crveni željezov oksid (E172).
Haematological adverse reactions
Nehematološke nuspojave
Imatinib Actavis 400 mg hard capsules
Imatinib Actavis 400 mg tvrde kapsule
Each hard capsule contains 400 mg of imatinib (as mesilate).
Svaka tvrda kapsula sadrži 400 mg imatiniba (u obliku imatinibmesilata).
Capsule shell Hypromellose Titanium dioxide (E171) Iron oxide yellow (E172)
Ovojnica kapsule hipromeloza titanijev dioksid (E171) željezov oksid, žuti (E172)
Each capsule contains 100 mg imatinib (as mesilate).
Svaka kapsula sadrži 100 mg imatiniba (u obliku imatinibmesilata).
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 300 mg.
<1,0 x 109/l i/ili trombociti <50 x 109/l, treba ponoviti 1. korak i nastaviti primjenu imatiniba u smanjenoj dozi od 260 mg/m