natgillin/translations-raw huggingface dataset:
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.
U patogenezu MDS/MPD-a, HES/KEL-a i DFSP-a uključena je ili konstitutivna aktivacija receptora za PDGF ili Abl proteintirozin kinaza koja nastaje kao posljedica fuzije za različite partnerske proteine ili konstitutivno stvaranje PDGF-a.
If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Imatinib Accord until ANC ≥ 1x109/1 and platelets ≥ 20x109/1, then resume treatment at 200 mg/m2.
Ako citopenija ustraje 4 tjedna i još uvijek nije povezana s leukemijom, prekinuti primjenu Imatinib Accorda sve dok ABN ne bude 1 x 109/i trombociti  20 x 109/l, nakon toga nastaviti liječenje u dozi od 200 mg/m2.
• Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red blood cells).
• blijeda koža, umor i gubitak daha te tamno obojena mokraća (znakovi snižene razine crvenih krvnih stanica).
• Feeling dizzy or weak.
• omaglica ili slabost.
Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms
Nepoznato Sindrom palmoplantarne eritrodisestezije*, lihenoidna keratoza*, lichen planus*, toksična epidermalna nekroliza*, osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (DRESS)* , pseudoporfirija* Poremećaji mišićno-koštanog sustava i vezivnog tkiva Vrlo često
Active substances that may decrease imatinib plasma concentrations
Djelatne tvari koje mogu smanjiti koncentracije imatiniba u plazmi:
Partial Haematological response criteria (all responses to be confirmed after ≥ 4 weeks): CHR: Study 0110 [WBC < 10 x 109/l, platelets < 450 x 109/l, myelocyte+metamyelocyte < 5% in blood, no blasts and promyelocytes in blood, basophils < 20%, no extramedullary involvement] and in studies 0102 and 0109 [ANC ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, no blood blasts, BM blasts < 5% and no extramedullary disease] NEL Same criteria as for CHR but ANC ≥ 1 x 109/l and platelets ≥ 20 x 109/l (0102 and 0109 only) RTC < 15% blasts BM and PB, < 30% blasts+promyelocytes in BM and PB, < 20% basophils in PB, no extramedullary disease other than spleen and liver (only for 0102 and 0109).
1 Kriteriji hematološkog odgovora (svi se odgovori moraju potvrditi nakon ≥4 tjedna): CHR: Studija 0110 [WBC < 10 x 109/l, trombociti < 450 x 109/l, mijelociti+metamijelociti <5% u krvi, u krvi nema blasta i promijelocita, bazofili < 20%, nema ekstramedularne zahvaćenosti], a u studijama 0102 i 0109 [ABN ≥ 1,5 x 109/l, trombociti ≥100 x 109/l, nema blasta u krvi, blasti u KS <5% i nema ekstramedularne bolesti]
Patients on imatinib treatment who are concerned about their fertility should consult with their physician.
Bolesnici zabrinuti radi svoje plodnosti tijekom liječenja Imatinib Accordom moraju se posavjetovati sa svojim liječnikom.
doses)iii: days 2 and 3
6 doza) iii: dani 2 i 3
Resume treatment with Imatinib Accord at 600 mg.
Ponovno uvesti liječenje Imatinib Accordom u dozi od 600 mg.
Hepatic function should be carefully monitored in circumstances where imatinib is combined with chemotherapy regimens also known to be associated with hepatic dysfunction (see section 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 4.5 i 4.8).
• Swelling such as round your ankles or puffy eyes.
• oticanje kao što je oticanje gležnjeva ili otečene oči.
Hypromellose 6 cps (E464) Talc (E553b)
Hipromeloza 6 cps (E464) talk (E553b) polietilenglikol željezov oksid, žuti (E172)
Treatment duration: In the only clinical trial performed up to now, treatment with imatinib was continued until disease progression (see section 5.1).
Trajanje liječenja: u jedinom kliničkom ispitivanju provedenom do sada, liječenje imatinibom je nastavljeno do progresije bolesti (vidjeti dio 5.1).U vrijeme analize, medijan trajanja liječenja bio je 47 mjeseci (24 dana-60 mjeseci).
Avascular necrosis/hip necrosis*, growth retardation in children and adolescents* Renal and urinary disorders
Nepoznato Avaskularna nekroza/nekroza kuka*, zastoj u rastu kod djece i adolescenata* Poremećaji bubrega i mokraćnog sustava
Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis
Manje često Stomatitis, ulceracija u ustima, gastrointestinalno krvarenje7, podrigivanje, melena, ezofagitis, ascites, želučani ulkus, hematemeza, heilitis, disfagija, pankreatitis
Maintenance (8-week cycles) Cycles 1cy
Održavanje (8-tjedni ciklusi) Ciklusi 1-4
• Severely decreased urine output, feeling thirsty (signs of kidney problems).
• jako smanjeno mokrenje, osjećaj žeđi (znakovi bubrežnih problema).
Imatinib Accord is also a treatment for children and adolescents with CML.
Accord se kod djece i adolescenata također koristi za liječenje KML-a.
DEX 10 mg/ m2 oral, days 1-5;
DEX 10 mg/m2peroralno, dani 1-5;
Active substances that may have their plasma concentration altered by imatinib
Djelatne tvari čije bi koncentracije u plazmi imatinib mogao promijeniti
• Pain or swelling in your abdomen, flatulence, heartburn or constipation.
• bol ili oticanje u trbuhu, vjetrovi, žgaravica ili zatvor.
Imatinib Accord is a treatment for adults for:
Accord se kod odraslih osoba koristi za liječenje:
Pleural effusion5, pharyngolaryngeal pain, pharyngitis
Manje često Pleuralni izljev5, faringolaringealna bol, faringitis Rijetko
Substances that are inducers of CYP3A4 activity (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidone or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to imatinib, potentially increasing the risk of therapeutic failure.
Tvari koje induciraju djelovanje CYP3A4 (npr. deksametazon, fenitoin, karbamazepin, rifampicin, fenobarbital, fosfenitoin, primidon ili Hypericum perforatum, poznat također kao gospina trava) mogu značajno smanjiti izloženost imatinibu, čime se potencijalno povećava rizik od neuspjeha terapije.
VCR 1.3 g/ m2 i.v., day 1; Prednisolone 60 mg/m2 oral, days 1-5
VCR 1,3 g/m2 i.v., dan 1; Prednizolon 60 mg/m2peroralno, dani 1-5
Hyperbilirubinaemia, hepatitis, jaundice
Manje često Hiperbilirubinemija, hepatitis, žutica Rijetko
Stop Imatinib Accord until ANC ≥ 1.5x109/1 and platelets ≥ 75x109/1.
Ukinuti Imatinib Accord sve dok ABN ne bude  1,5 x 109/l i trombociti 75 x 109/l.
How much Imatinib Accord to take
Koliko Imatinib Accorda uzeti
• 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 probavnih problema).
Newly diagnosed Ph+ ALL
Novodijagnosticirani Ph+ ALL
Migraine, somnolence, syncope, peripheral neuropathy, memory impairment, sciatica, restless leg syndrome, tremor, cerebral haemorrhage
Omaglica, parestezija, poremećaj okusa, hipoestezija Manje često Migrena, pospanost, sinkopa, periferna neuropatija, poremećaj pamćenja, ishijalgija, sindrom nemirnih nogu, tremor, cerebralno krvarenje
• Bruising.
• svrbež.
Dose increases from 340 mg/m2 daily to 570 mg/m2 daily (not to exceed the total dose of 800 mg) may be considered in children and adolescents 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.
(ne smije se prekoračiti ukupna doza od 800 mg) u odsustvu teške nuspojave na lijek i teške neutropenije ili trombocitopenije nepovezanih 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.
DEX 10 mg/m2 oral, days 1-5; CP 200 mg/ m2 i.v., days 3, 4, 5;
DEX 10 mg/m2peroralno, dani 1-5; CP 200 mg/m2 i.v., dani 3, 4, 5;
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg of imatinib (as mesilate).
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 100 mg imatiniba (u obliku imatinibmesilata).
The dose is 800 mg per day (to be taken as 4 tablets of 100 mg or 1 tablet of 400 mg in the morning and 4 tablets of 100 mg or 1 tablet of 400 mg in the evening.
Doza je 800 mg na dan, koja se uzima kao 4 tablete od 100 mg ili 1 tableta od 400 mg ujutro i 4 tablete od 100 mg ili 1 tableta od 400 mg navečer.
• Painful and/or blistering skin lesions.
• lezije (oštećenja) kože koje su bolne i/ili s mjehurićima.
Gynaecomastia, erectile dysfunction, menorrhagia, menstruation irregular, sexual dysfunction, nipple pain, breast enlargement, scrotal oedema
Manje često Ginekomastija, erektilna disfunkcija, menoragija, nepravilne mjesečnice, poremećaj seksualne funkcije, bol u bradavicama, povećanje dojki, edem skrotuma
Very common Weight increased Common
Povećana tjelesna težina
Thisinhibition has not been observed in vivoafter the administration of imatinib 400 mg and paracetamol 1000 mg. Higher doses of imatinib and paracetamol have not been studied.
Ovakva inhibicija nije uočena in vivo nakon primjene imatiniba u dozi od 400 mg i paracetamola u dozi od 1000 mg.
Maintenance (8-week cycles) Cycle 5
Održavanje (8-tjedni ciklusi)
• 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).
Eye irritation, eye pain, orbital oedema, scleral haemorrhage, retinal haemorrhage, blepharitis, macular oedema
Manje često Iritacija oka, bol u oku, orbitalni edem, krvarenje bjeloočnice, krvarenje mrežnice, blefaritis, makularni edem
Five (5) patients with MDS/MPD associated with PDGFR gene re-arrangements were reported in 4 publications.
U 4 publikacije zabilježeno je 5 bolesnika s MDS/MPD-om povezanim s preraspodjelom gena za PDGFR.
How to take Imatinib Accord
Kako uzimati Imatinib Accord
Musculoskeletal and connective tissue disorders Very common Muscle spasm and cramps, musculoskeletal pain including myalgia9, arthralgia,
Spazam mišića i grčevi, mišićno-koštana bol uključujući mialgiju9, artralgiju, bol u kostima10
Palpitations, tachycardia, cardiac failure congestive3, pulmonary oedema
Manje često Palpitacije, tahikardija, kongestivno zatajenje srca3, plućni edem Rijetko
Depending on your condition the usual starting dose is either 400 mg or 600 mg: - 400 mg to be taken as 4 tablets of 100 mg or 1 tablet of 400 mg once a day - 600 mg to be taken as 6 tablets of 100 mg or 1 tablet of 400 mg plus 2 tablets of 100 mg once a day.
Ovisno o Vašem stanju, uobičajena početna doza je ili 400 mg ili 600 mg: 400 mg se uzima kao 4 tablete od 100 mg ili 1 tableta od 400 mg jednom na dan.
Methylprednisolone 40 mg intrathecal, day1
Metilprednizolon 40 mg intratekalno, dan 1
Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL).
- Akutne limfoblastične leukemije s pozitivnim Philadelphia kromosomom (Ph-pozitivni ALL).
Imatinib Accord 400 mg film-coated tablets are brownish orange, oval shaped, biconvex, film-coated tablets, debossed on one side with ‘IM' and ‘T2' on either side of breakline and plain on the other side.
Imatinib Accord 400 mg filmom obložene tablete su smećkastonarančaste, ovalne, bikonveksne filmom obložene tablete s utisnutom oznakom „IM“ s jedne strane razdjelne crte i oznakom „T2“ s druge strane razdjelne crte te bez oznaka na drugoj strani tablete.
Increased intracranial pressure, convulsions, optic neuritis
Povišen intrakranijalni tlak, konvulzije, optički neuritis Nepoznato Cerebralni edem* Poremećaji oka
Herpes zoster, herpes simplex, nasopharyngitis, pneumonia1, sinusitis,cellulitis, upper respiratory tract infection, influenza, urinary tract infection, gastroenteritis, sepsis
Manje često Herpes zoster, herpes simplex, nazofaringitis, upala pluća1, sinusitis, celulitis,
Caution should be taken when administering imatinib with inhibitors of the CYP3A4 family.
Kada se imatinib primjenjuje s inhibitorima obiteljiCYP3A4, potrebno je oprezno postupati.
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
• Joint pain with swelling.
• bolovi u zglobovima s oticanjem.
Three (3) patients with HES and CEL associated with PDGFR gene re-arrangements were reported in 3publications.
U 3 publikacije zabilježena su 3 bolesnika s HES-om i KEL-om povezanim s preraspodjelom gena za PDGFR.
G-CSF (5 μg/kg, SC): days 4-13 or until ANC > 1500 post nadir
G-CSF (5 μg/kg, s.c.): dani 5-14 ili do porasta ANC >1500 nakon najniže izmjerene vrijednosti
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 14C-označene doze imatiniba, oko 81% doze izlučilo se u roku od 7 dana u stolici (68% doze) i mokraći (13% doze).
ANC < 1.0x109/l and/or platelets < 50 x 109/l
ABN <1,0 x 109/l i/ili trombociti <50 x 109/l
Imatinib Accord 400 mg tablets
Imatinib Accord 400 mg tablete
Imatinib Accord 100 mg film-coated tablets are brownish orange, round biconvex, film-coated tablets, debossed on one side with ‘IM' and ‘T1' on either side of breakline and plain on the other side.
Imatinib Accord100 mg filmom obložene tablete su smećkastonarančaste, okrugle, bikonveksne filmom obložene tablete s utisnutom oznakom „IM“ s jedne strane razdjelne crte i oznakom „T1“ s druge strane razdjelne crte te bez oznaka na drugoj strani tablete.
Imatinib Accord 100 mg tablets
Imatinib Accord 100 mg tablete
Reproductive system and breast disorders Uncommon
Poremećaji reproduktivnog sustava i dojki
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 Accord at reduced dose of 300 mg.
U slučaju da je ABN ponovno < 1,0 x 109/l i/ili trombociti < 50 x 109/l, treba ponoviti 1. korak i nastaviti primjenu Imatinib Accorda u smanjenoj dozi od 300 mg.
• Difficulty hearing.
• oslabljen sluh.
Ara-C 40 mg intrathecal, days 1, 8, 15, 22;
Ara-C 40 mg intratekalno, dani 1, 8, 15, 22;
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.
Kad se stopa odgovora računa u bolesnika s barem jednom valjanom procjenom, stopa odgovora za CHR, CCyR i MR bila je 20/22
All patients achieved complete haematological response, cytogenetic response and/or clinical response.
citogenetski odgovor i/ili klinički odgovor.
Ileus/intestinal obstruction*, gastrointestinal perforation*, diverticulitis*, gastric antral vascular ectasia (GAVE)* Hepatobiliary disorders Common
Nepoznato Ileus/intestinalna opstrukcija*, gastrointestinalna perforacija*, divertikulitis*,
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 pregledu kod specijaliste kardiologa, obavljanje ehokardiograma i određivanje serumskog troponina.
Five (5) patients with DFSP and PDGFR gene re-arrangements were reported in 3 publications.
U 3 publikacije zabilježeno je 5 bolesnika s DFSP-om i preraspodjelom PDGFR gena.
In the event of recurrence of ANC < 1.0 x 109/1 and/or platelets < 50 x 109/1, repeat step 1 and resume Imatinib Accord at reduced dose of 260 mg/m2.
U slučaju da je ABN ponovno < 1,0 x109/l i/ili trombociti < 50 x109/l, treba ponoviti 1. korak i nastaviti primjenu Imatinib Accorda u smanjenoj dozi od 260 mg/m2.
In paediatric CML patients the most frequent toxicities observed were grade3 or 4 cytopenias involving neutropenia, thrombocytopenia and anaemia.
U pedijatrijskih KML bolesnika najčešće uočene toksičnosti bile su citopenije 3. ili
ARA-C (3 g/m2/dose q 12 h x 4, IV): days 2 and 3
ARA-C (3 g/m2, svakih 12 sati, i.v.): dani 43, 44
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
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
• Chronic renal failure
• kronično zatajenje bubrega
The recommended dose of Imatinib is 800 mg/day for adult patients with DFSP.
Za odrasle bolesnike DFSP-om preporučena doza imatiniba iznosi 800 mg/dan.
• Mouth ulcers.
• čirevi u ustima.
Each film-coated tablet contains 400 mg of imatinib (as mesilate).
Jedna filmom obložena tableta sadrži 400 mg imatiniba (u obliku imatinibmesilata).
A total of 1,106 patients were randomised, 553 to each arm. Baseline characteristics were well balanced between the two arms.
Ukupan broj od 1106 bolesnika je randomiziran po 553 ispitanika u svaki krak.
Each 400 mg film-coated tablet of Imatinib Accord contains 400 mg imatinib (as mesilate).
Jedna filmom obložena tableta Imatinib Accorda od 400 mg sadrži 400 mg imatiniba (u obliku imatinibmesilata).
How to store Imatinib Accord
Kako čuvati Imatinib Accord
Cytogenetic response
Veliki citogenetski odgovor2
Cytogenetic response criteria: complete (0% Ph+ metaphases), partial (1-35%), minor (36-65%) or minimal (66-95%).
Veliki odgovor je kombinacija potpunih i djelomičnih odgovora: potpuni (0% Ph+ metafaza), djelomični (1-35%)
Thrombosis/embolism*
Nepoznato Tromboza/embolija
Each 100 mg film-coated tablet of Imatinib Accorcd ontains 100 mg imatinib (as mesilate).
Jedna filmom obložena tableta Imatinib Accorda od 100 mg sadrži 100 mg imatiniba (u obliku imatinibmesilata).
Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia, lymphadenopathy
Manje često Trombocitemija, limfopenija, depresija koštane srži, eozinofilija, limfadenopatija Rijetko
Imatinib Accord 100 mg film-coated tablets Imatinib Accord 400 mg film-coated tablets imatinib
Imatinib Accord 100 mg filmom obložene tablete Imatinib Accord 400 mg filmom obložene tablete imatinib
MTX 1.5 g/ m2 i.v.
MTX 1,5 g/m2 i.v. (24 h), dan 1;
(3h), days1-4; 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;
The recommended dose of Imatinib Accord is 400 mg/day for adult patients with MDS/MPD.
Za odrasle bolesnike s MDS/MPD-om preporučena doza Imatinib Accorda iznosi 400 mg/dan.
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Nakon dobivanja odobrenja lijeka važno je prijavljivanje sumnji na njegove nuspojave.Time se omogućuje kontinuirano praćenje omjera koristi i rizika lijeka.
Additionally Imatinib Accord 100 mg tablets are also available in PVC/PVdC/Alu perforated unit dose blister in pack-sizes of 30x1, 60x1, 90x1, 120x1 or 180x1 film-coated tablets.
Pored toga, Imatinib Accord 100 mg tablete također su dostupne u PVC/PVdC/Alu perforiranom blisteru s jediničnim dozama u veličinama pakiranja od 30x1, 60x1, 90x1, 120x1 ili 180x1 filmom obložena tableta.
MTX 15 mg intrathecal, day1;
MTX 15 mg intratekalno, dan 1;
Very common Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain6 Common
Mučnina, proljev, povraćanje, dispepsija, bol u trbuhu6
The recommended dosage of Imatinib Accord is 600 mg/day for adult patients in accelerated phase.
Za odrasle bolesnike u ubrzanoj fazi preporučena doza Imatinib Accorda iznosi 600 mg/dan.
- if you experience bruising, bleeding, fever, fatigue and confusion when taking Imatinib Accord, contact your doctor.
Prije početka liječenja liječnik će pažljvo pregledati bolesnike radi utvrđivanja eventualnih znakova te infekcije. - ako dobijete modrice, krvarenje, vrućicu, umor i smetenost prilikom uzimanja Imatinib Accorda, kontaktirajte liječnika.
Investigations
dijagnoze
(1 h), days 28-31, 35-38, 42-45; 6-MP 60 mg/ m2 oral, days 26-46
Indukcijska terapija II 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/m2peroralno, dani 26-46
Additionally Imatinib Accord 400 mg tablets are available in PVC/PVdC/Alu perforated unit dose blister in pack-sizes of 30x1, 60x1 or 90x1 film-coated tablets.
Pored toga, Imatinib Accord 400 mg tablete dostupne su u PVC/PVdC/Alu perforiranom blisteru s jediničnim dozama u veličinama pakiranja od 30x1, 60x1 ili 90x1 filmom obložena tableta.
In the event of recurrence of ANC < 1.0x109/1 and/or platelets < 50x109/1, repeat step1 and resume Imatinib Accordat reduced dose of 400 mg.
U slučaju da je ABN ponovno < 1,0 x 109/l i/ili trombociti < 50 x 109/l, treba ponoviti 1. korak i nastaviti primjenu Imatinib Accorda u smanjenoj dozi od 400 mg.
Additionally Imatinib Accord 100 mg tablets are also available in perforated unit dose blister packs (PVC/PVdC/Alu) containing 30x1, 60x1, 90x1, 120x1 or 180x1 film-coated tablets.
Pored toga, Imatinib Accord 100 mg tablete također su dostupne u perforiranom blisteru s jediničnim dozama (PVC/PVdC/Alu) u veličinama pakiranja od 30x1, 60x1, 90x1, 120x1 ili 180x1 filmom obložena tableta.
VCR (1.5 mg/m2/day, IV): days 1, 29
VCR (1,5 mg/m2/dan, i.v.): dani 1, 8, i 15
(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
ANNEX III LABELLING AND PACKAGE LEAFLET
Tablica 1 Tablični sažetak nuspojava
Methylprednisolone 40 mg intrathecal, days 1, 8, 15, 22
Metilprednizolon 40 mg intratekalno, dani 1, 8, 15, 22
Imatinib Accord 100 mg film-coated tablets
Imatinib Accord 100 mg filmom obložene tablete
Additionally Imatinib Accord 400 mg tablets are available in perforated unit dose blister packs (PVC/PVdC/Alu) containing 30x1, 60x1or 90x1 film-coated tablets.
Pored toga, Imatinib Accord 400 mg tablete dostupne su u perforiranom blisteru s jediničnim dozama (PVC/PVdC/Alu) u veličinama pakiranja od 30x1, 60x1 ili 90x1 filmom obložena tableta.
Imatinib Accord 400 mg film-coated tablets
Imatinib Accord 400 mg filmom obložene tablete
Moderate
Umjereni
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.
Doxorubicine 50 mg/ m2 i.v.
Doksorubicin 50 mg/m2 i.v. (24 h), dan 4;
MARKETING AUTHORISATION NUMBER(S) EU/1/13/845/001-004
Imatinib Accord 100 mg tablete EU/1/13/845/001-004
The recommended dose of Imatinib is 600 mg/day for adult patients in blast crisis.
Za odrasle bolesnike u blastičnoj krizi preporučena doza imatinibaiznosi 600 mg/dan.
If your daily dose is 800 mg (8 tablets of 100 mg or 2 tablets of 400 mg).
Ako Vaša dnevna doza iznosi 800 mg (8 tableta od 100 mg ili 2 tablete od 400 mg), trebate uzimati 4 tablete od 100 mg ili 1 tabletu od 400 mg ujutro i 4 tablete od 100 mg ili 1 tabletu od 400 mg navečer.
(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/m2peroralno, dani 1-20
urethra, preputial and clitoral gland, small intestine, parathyroid glands, adrenal glands and nonglandular stomach.
Ciljni organi neoplastičkih promjena bili su bubrezi, mokraćni mjehur, uretra, žlijezda prepucija i klitorisa, tanko crijevo, paratireoidne žlijezde, nadbubrežne žlijezde i nežljezdani dio želuca.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/845/009-011
Imatinib Accord 400 mg tablete EU/1/13/845/009-011
Hypertension, haematoma, subdural haematoma, peripheral coldness, hypotension, Raynaud's phenomenon
Manje često Hipertenzija, hematom, subduralni hematom, periferna hladnoća, hipotenzija,