natgillin/translations-raw huggingface dataset:
Imatinib Teva B.V. inhibits the growth of these cells in a certain subtype of these diseases.
zavira rast teh celic pri določenih podskupinah teh bolezni.
Imatinib Teva B.V. 100 mg film-coated tablets Pack sizes of 60 or 120 film-coated tablets in blisters.
100 mg filmsko obložene tablete Škatle, ki vsebujejo po 60 ali 120 filmsko obloženih tablet v pretisnem omotu.
The starting dose is 100 mg, to be taken as one capsule of 100 mg once a day.
Začetni odmerek je 100 mg, ki ga vzamete kot eno kapsulo po 100 mg enkrat na dan.
• Pain or swelling in your abdomen, flatulence, heartburn or constipation.
• bolečine v trebuhu ali napihnjen trebuh, vetrovi, zgaga ali zapeka, • neobičajno izpadanje ali tanjšanje las,
If your daily dose is 800 mg (2 capsules), you should take one capsule in the morning and a
Če je vaš dnevni odmerek 800 mg (2 kapsuli), morate vzeti eno kapsulo zjutraj in eno kapsulo zvečer.
Hypertension, haematoma, subdural haematoma, peripheral coldness,
hipertenzija, hematom, subduralni hematom, hladni distalni deli udov, hipotenzija, Raynaudov fenomen pogostnost neznana:
Talk to your doctor before taking Imatinib Teva B.V.: - if you have or have ever had a liver, kidney or heart problem.
se posvetujte z zdravnikom: - če imate ali ste kdaj imeli težave z jetri, ledvicami ali srcem; - če jemljete zdravilo levotiroksin, ker so vam odstranili ščitnico.
The recommended dose of Imatinib Teva B.V. is 400 mg/day for adult patients with unresectable and/or metastatic malignant GIST.
pri odraslih bolnikih z neresektabilnimi in/ali metastatskimi malignimi GIST je 400 mg/dan.
The starting dose is 100 mg, to be taken as one tablet of 100 mg once a day.
Začetni odmerek je 100 mg, ki ga vzamete kot eno tableto po 100 mg enkrat na dan.
Population pharmacokinetics
5.1 Farmakodinamične lastnosti
Imatinib Teva B.V. 400 mg film-coated tablets
400 mg filmsko obložene tablete imatinib
Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia, hyperglycaemia, hyponatraemia
zmanjšan apetit, dehidracija, protin, hiperurikemija, hiperkalciemija, hiperglikemija, hiponatriemija hiperkaliemija, hipomagneziemija nespečnost depresija, zmanjšan libido, anksioznost zmedenost glavobol2
Treatment with imatinib for 36 months was superior to treatment for 12 months in the ITT analysis, i.e. including the entire study population.
Rezultati analize ITT, ki obsega celotno študijsko populacijo, kažejo, da je 36-mesečno zdravljenje z imatinibom boljše od 12-mesečnega zdravljenja.
• Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or having blurred vision.
• izcedek iz oči s srbenjem, rdečino in otekanjem (vnetje očesne veznice), prekomerno solzenje ali
RFS
AFIP
Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia,
zmanjšan apetit, dehidracija, protin, hiperurikemija, hiperkalciemija, hiperglikemija, hiponatriemija redki:
Imatinib Teva B.V. 100 mg film-coated tablets Each film-coated tablet contains 100 mg of imatinib (as mesilate).
100 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 100 mg imatiniba (v obliki mesilata).
The usual starting dose is 600 mg to be taken as 6 capsules once a day.
Običajni začetni odmerek je 600 mg, ki ga vzamete kot 6 kapsul enkrat na dan.
RFS rates (%) 12 month 24 month Imatinib vs placebo
delež bolnikov s preživetjem brez ponovitve bolezni (%) 12 mesecev 24 mesecev imatinib v primerjavi s placebom imatinib v primerjavi s placebom
Your doctor will tell you exactly how many capsules of Imatinib Teva B.V. to take.
Zdravnik vam bo natančno povedal, koliko kapsul zdravila 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 260 mg/m2.
Če se pojav/a ANC < 1,0 x 109/l in/ali koncentracija trombocitov < 50 x 109/l ponovi/ta, ponovite točko 1 in spet začnite zdravljenje z imatinibom z zmanjšanim odmerkom 260 mg/m2.
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 filmsko obložene tablete je pakirano v škatli po 30 ali 90 filmsko Zdravilo Imatinib Teva B.V.
No overall survival benefit has been observed.
vendar vpliv tega pojava na celotno preživetje še vedno ni znan.
When given with a high-fat meal, the rate of absorption of imatinib was minimally reduced (11% decrease in Cmax and prolongation of tmax by 1.5 h), with a small reduction in
Če so imanitib dajali z zelo mastnim obrokom, se je obseg njegove absorpcije minimalno zmanjšal (Cmax se je zmanjšala za
Imatinib Teva B.V. 100 mg film-coated tablets
100 mg filmsko obložene tablete imatinib
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 filmsko obložene tablete je pakirano v škatli po 20x1, 60x1, 120x1 ali 180x1 v perforiranih pretisnih omotih za posamezne odmerke.
Imatinib Teva B.V. 100 mg hard capsules are available in pack sizes of 60 or 120 hard capsules in blisters.
100 mg trde kapsule je pakirano v škatli po 60 ali 120 trdih kapsul v Zdravilo Imatinib Teva B.V.
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 trde kapsule so neprozorne oranžne kapsule s črno oznako 7629
Imatinib Teva B.V. 400 mg film-coated tablets Each film-coated tablet contains 400 mg of imatinib (as mesilate).
400 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 400 mg imatiniba (v obliki mesilata).
Imatinib adverse events, i.e. hepatotoxicity, myelosuppression or others, may increase and it has been reported that concomitant use with L-asparaginase could be associated with increased hepatotoxicity (see section 4.8).
Poročali so, da bi bila lahko sočasna uporaba L asparaginaze povezana z bolj izraženo toksičnostjo za jetra (glejte poglavje 4.8).
Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, Colitis, ileus, inflammatory bowel disease Ileus/intestinal obstruction*, gastrointestinal perforation*, diverticulitis*, gastric antral vascular ectasia (GAVE)*
disfagija, pankreatitis kolitis, ileus, vnetna bolezen črevesa ileus/zapora črevesja*, gastrointestinalna perforacija*, divertikulitis*, žilne ektazije antruma želodca (GAVE)*
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.): 5.-14. dan oziroma do ANC > 1500 po doseženem trojno i.t.
NAME OF THE MEDICINAL PRODUCT Imatinib Teva B.V. 100 mg hard capsules Imatinib Teva B.V. 400 mg hard capsules
100 mg trde kapsule Imatinib Teva B.V.
Imatinib Teva B.V. 400 mg film-coated tablets Pack sizes of 30 or 90 film-coated tablets in blisters.
400 mg filmsko obložene tablete Škatle, ki vsebujejo po 30 ali 90 filmsko obloženih tablet v pretisnem omotu.
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
): 22.-26. dan G-CSF (5 μg/kg, s.c.): 27.-36. dan oziroma do ANC > 1500 po doseženem
Liver function tests
Moteno delovanje organov
Pack sizes of 20x1, 60x1, 120x1 or 180x1 hard capsules in perforated unit dose blisters.
Škatla, ki vsebuje po 20x1, 60x1, 120x1 ali 180x1 trdih kapsul v perforiranem pretisnem omotu za
a ANC < 0.5 x 109/l and/or platelets < 10 x 109/l
aANC < 0,5 x 109/l in/ali koncentracija trombocitov
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 filmsko obložene tablete Temno rumena do rjavkastooranžna filmsko obložena tableta, okrogla in z zarezo na eni strani.
Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis,
flatulenca, napihnjen trebuh, gastroezofagealni refluks, obstipacija, suha usta, gastritis stomatitis, razjede ustne sluznice, krvavitev iz prebavil7, spahovanje, melena, ezofagitis, ascites,
Palpitations, tachycardia, cardiac failure congestive3, pulmonary oedema Arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction,
Ušesne bolezni, vključno z motnjami labirinta vrtoglavica, zvonjenje v ušesih, izguba sluha palpitacije, tahikardija, kongestivno popuščanje srca3, pljučni edem aritmija, atrijska fibrilacija, zastoj srca, miokardni infarkt, angina pektoris, perikardialni izliv perikarditis*, tamponada srca*
The starting dose is 100 mg, to be taken as one capsule once a day.
Začetni odmerek je 100 mg, ki ga vzamete kot eno kapsulo enkrat na dan.
The starting dose is 400 mg, to be taken as one capsule once a day.
Začetni odmerek je 400 mg, ki ga vzamete kot eno kapsulo enkrat na dan.
The doctor will tell you how many tablets of Imatinib Teva B.V. to give to your child.
Zdravnik vam bo povedal, koliko tablet zdravila Imatinib Teva B.V.
These are blood diseases in which some blood cells (named eosinophils) start growing out of control.
To so bolezni krvi, pri katerih se začnejo nenadzorovano razraščati nekatere krvne celice
Not known:
je indicirano za:
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 filmsko obložene tablete Imatinib Teva B.V.
6.6 Special precautions for disposal
6.1 Seznam pomožnih snovi
Your doctor may decide to increase the dose to 400 mg, to be taken as 4 tablets once a day, depending on how you respond to treatment.
Zdravnik se lahko odloči za zvečanje odmerka na 400 mg, ki ga vzamete kot 4 tablete enkrat na dan, odvisno od vašega odziva na zdravljenje.
Anaphylactic shock* Blood and lymphatic system disorders
anafilaktični šok*
(q 12 h), days 2-3, for 4 cycles VCR 1.3 g/m2 i.v., day 1;
ur), 2.-3. dan, v 4 ciklusih VCR 1,3 g/m2 i.v., 1. dan; prednizolon 60 mg/m2
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.
Zdravnik se lahko odloči za zvečanje odmerka na 400 mg, ki ga vzamete kot eno kapsulo po 400 mg enkrat na dan, odvisno od vašega odziva na zdravljenje.
The printing ink is composed of shellac, iron oxide black (E172) and propylene glycol.
Tiskarska barva pa vsebuje šelak, črni železov oksid (E172) in
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 trde kapsule je pakirano v škatli po 30x1 ali 90x1 trdih kapsul v perforiranem pretisnem omotu za posamezne odmerke.
The starting dose is 100 mg, to be taken as one tablet once a day.
Začetni odmerek je 100 mg, ki ga vzamete kot eno tableto enkrat na dan.
The starting dose is 400 mg, to be taken as one tablet once a day.
Začetni odmerek je 400 mg, ki ga vzamete kot eno tableto enkrat na dan.
Your doctor may decide to increase the dose to 400 mg, to be taken as 4 capsules once a day, depending on how you respond to treatment.
Zdravnik se lahko odloči za zvečanje odmerka na 400 mg, ki ga vzamete kot 4 kapsule enkrat na dan, odvisno od vašega odziva na zdravljenje.
Pack sizes of 30x1 or 90x1 hard capsules in perforated unit dose blisters.
Škatla, ki vsebuje po 30x1 ali 90x1 trdih kapsul v perforiranem pretisnem omotu za posamezne
This is because Imatinib Teva B.V.
Zaradi zdravila Imatinib Teva B.V.
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.
Zdravnik se lahko odloči za zvečanje odmerka na 400 mg, ki ga vzamete kot eno tableto po 400 mg enkrat na dan, odvisno od vašega odziva na zdravljenje.
All 65
do 59).
Methylprednisolone 40 mg intrathecal, days 1, 8, 15, 22 Ara-C 1,000 mg/m2/12 h i.v.
Ara-C 40 mg intratekalno, 1., 8., 15., 22. dan; metilprednizolon 40 mg intratekalno, 1., 8., 15., 22. dan Konsolidacija (novo odkrita Ph+ ALL) Ara-C 1.000 mg/m2/12 ur i.v.
Imatinib Teva B.V. 400 mg hard capsules are available in pack sizes of 30 or 90 hard capsules in blisters.
400 mg trde kapsule je pakirano v škatli po 30 ali 90 trdih kapsul v Zdravilo Imatinib Teva B.V.
Imatinib vs placebo
AUC imatiniba.
CP 1 g/m2 i.v.
Ara-C 1 g/m2 i.v.
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 filmsko obložene tablete je pakirano v škatli po 60 ali 120 filmsko obloženih tablet v pretisnem omotu.
If you have any questions about how Imatinib Teva B.V. works or why this medicine has been prescribed for you, ask your doctor.
Če imate kakšna vprašanja glede tega, kako zdravilo Imatinib Teva B.V.
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 trde kapsule je pakirano v škatli po 20x1, 60x1, 120x1 ali 180x1 trdih kapsul v perforiranem pretisnem omotu za posamezne odmerke.
Methotrexate (20 mg/m2/week, PO): days 1, 8, 15, 22, 29, 36, 43, 50
metotreksat (20 mg/m2/teden, peroralno): 8., 15., 22., 29., 36., 43. in 50. dan VCR (1,5 mg/m2/dan, i.v.
The recommended dose of Imatinib Teva B.V. is 100 mg/day for adult patients with HES/CEL.
pri odraslih bolnikih s HES/CEL je 100 mg/dan.
Table 6 Summary of Z9001 trial RFS analyses by NIH and AFIP risk classifications
Preglednica 6 Povzetek študije Z9001: analiza preživetja brez ponovitve bolezni po tveganj kov skupno razmerje tveganj (95 % IZ)*
Imatinib Teva B.V. 100 mg hard capsules Each hard capsule contains 100 mg of imatinib (as mesilate).
100 mg trde kapsule Ena kapsula vsebuje 100 mg imatiniba (v obliki mesilata).
Therefore, caution should be recommended when driving a car
Zato je treba bolnikom, ki vozijo avto ali uporabljajo
In a planned subgroup analysis by mutation type, the HR for RFS for 36 months of treatment for patients with mutations of exon 11 was 0.35 [95% CI: 0.22, 0.56].
razmerje tveganj za preživetje brez ponovitve bolezni 0,35 [95-odstotni IZ: 0,22, 0,56].
The recommended dose of Imatinib Teva B.V. is 600 mg/day for adult patients in blast crisis.
za odrasle bolnike v blastni krizi je 600 mg/dan.
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 zdravljenje odraslih bolnikov po resekciji GIST je priporočeni odmerek zdravila Imatinib Teva B.V.
The age of these patients ranged from newborn to 14 years and imatinib was given at dose 50 mg daily or doses ranging from 400 to 520 mg/m2 daily.
Ti bolniki so bili stari od starosti novorojenčka do 14 let, imatinib pa so prejemali v odmerku 50 mg na dan oziroma v na dan.
The recommended dose of Imatinib Teva B.V. is 800 mg/day for adult patients with DFSP.
pri odraslih bolnikih z DFSP je 800 mg/dan.
If any of these apply to you, tell your doctor before taking Imatinib Teva B.V.
Če kaj od zgoraj navedenega velja za vas, se še pred jemanjem zdravila Imatinib Teva B.V.
The increase in mean AUC with increasing dose was linear and dose proportional in the range of 25-1,000 mg imatinib after oral administration.
Po peroralnem dajanju zdravim prostovoljcem je bil t1/2 približno 18 ur, kar kaže na ustreznost enega odmerka na dan. Zvečevanje povprečne AUC z večanjem odmerka je bilo po peroralnem dajanju linearno in sorazmerno odmerku v območju 25-1000 mg imatiniba.
Imatinib Teva B.V. 400 mg hard capsules Each hard capsule contains 400 mg of imatinib (as mesilate).
400 mg trde kapsule Ena kapsula vsebuje 400 mg imatiniba (v obliki mesilata).
CPM (250 mg/m2/dose q12h x 4 doses, IV): days 3 and 4
): 1. in 2. dan CPM (250 mg/m2/odmerek vsakih 12 ur x 4 odmerki, i.v.
Increased hepatic enzymes
hemolitična anemija
Clinical studies in chronic myeloid leukaemia
Preglednica 2 Odziv pri odraslih bolnikih s KML v kliničnih študijah
Prephase
Študija ADE10 Predhodna faza
Imatinib Teva B.V. 400 mg hard capsules
400 mg trde kapsule imatinib
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 filmsko obložene tablete so temno rumene do rjavkastooranžne, podolgovate filmsko obložene tablete, z zarezo na eni strani ter z oznako “IT” na eni strani zareze in “4” na drugi strani zareze.
Posology for CML in children
Za otroke s kronično fazo KML
These include some types of cancer.
lahko enako vpliva na nekatera druga zdravila.
Posology for DFSP The recommended dose of Imatinib Teva B.V. is 800 mg/day for adult patients with DFSP.
Odmerjanje pri DFSP Priporočeni odmerek zdravila Imatinib Teva B.V.
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
lihenoidna keratoza*, lichen planus*, toksična epidermalna nekroliza*, izpuščaj zaradi zdravila z eozinofilijo in sistemskimi simptomi (DRESSdrug rash with eosinophilia and systemic symptoms)*
4.4 Special warnings and precautions for use
OZNAČEVANJE IN NAVODILO ZA UPORABO
100 vs. 98.1 100 vs. 93.0
v pr. z 98,1
Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia,
ginekomastija, erektilna disfunkcija, menoragija,
Hepatic failure8, hepatic necrosis Skin and subcutaneous tissue disorders Periorbital oedema, dermatitis/eczema/rash Pruritus, face oedema, dry skin, erythema, alopecia, night sweats,
Bolezni jeter, žolčnika in žolčevodov zvišani jetrni encimi hiperbilirubinemija, hepatitis, ikterus odpoved jeter8, nekroza jeter periorbitalni edemi, dermatitis/ekcem/izpuščaj pruritus, edem obraza, suha koža, eritem,
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 IT Methotrexate (age-adjusted): day 1 ONLY Triple IT therapy (age-adjusted): day 8, 15
): 1. in 29. dan DEX (6 mg/m2/dan, peroralno): 1.-5. dan in 29.-33. dan 6-MP (75 mg/m2/dan, peroralno: 8.-28. dan metotreksat (20 mg/m2/teden, peroralno): 8., 15. in 22. dan
imatinib teva b.v. 100 mg hard capsules
100 mg trde kapsule imatinib
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,
Odmerki od 1200 mg do 1600 mg (trajanje zdravljenja od 1 do 10 dni): navzea, bruhanje, driska,
Pruritus, face oedema, dry skin, erythema, alopecia, night sweats, photosensitivity reaction
alopecija, nočno potenje, fotosenzitivna reakcija gnojen izpuščaj, kontuzije, povečano potenje,
100 vs. 100 97.8 vs. 100
v pr. z 98,7
Bilirubin
Blister
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
G-CSF (5 μg/kg, s.c.): 6.-15. dan oziroma do ANC > 1500 po doseženem i.t.
Hyperkalaemia, hypomagnesaemia
hipokaliemija, povečan apetit, hipofosfatemija,
imatinib teva b.v. 400 mg hard capsules
400 mg trde kapsule
- 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
Med zdravljenjem z zdravilom Imatinib Teva B.V ne dojite.
They are usually
Navadno so blagi do zmerni.
AUC (7.4%) compared to fasting conditions.
11 %, tmax pa se je podaljšal za 1,5 ure), AUC pa se je v primerjavi z razmerami na tešče malo zmanjšala (7,4 %).
12 months 24 months
zmerno 24,6
VCR (1.5 mg/m2/day, IV): days 1, 8 and 15
VCR (1,5 mg/m2/dan, i.v.
Imatinib Teva B.V. is indicated for
Imatinib Teva B.V.
• 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.
• mišični krči ali bolečine v sklepih, mišicah ali kosteh v obdobju, ko se zdravite z zdravilom
Study AIT07 was a multicentre, open-label, randomised, phase II/III study that included 128 patients (1 to < 18 years) treated with imatinib in combination with chemotherapy.
128 bolnikov (starih od 1 do manj kot 18 let) in jih zdravili z imatinibom v kombinaciji s kemoterapijo.
Dose reduction or treatment interruption for severe neutropenia and thrombocytopenia are recommended as
Pri hudi nevtropeniji in trombocitopeniji je priporočljivo zmanjšanje odmerka ali prekinitev zdravljenja, kot kaže spodnja preglednica.
Hyperbilirubinaemia, hepatitis, jaundice
želodčna razjeda, hematemeza, vnetje ustnice,
18 Gy in 10 fractions for patients that are CNS3 at diagnosis
18 Gy v 10 frakcijah za bolnike, ki imajo ob postavitvi diagnoze CNS3 VCR (1,5 mg/m2/dan, i.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.
109/l in/ali koncentracija trombocitov < 50 x 109/l ponovi/ta, ponovite točko 1 in spet začnite zdravljenje z imatinibom z zmanjšanim odmerkom 400 mg.
Main demographics in TURQUOISE-III
Glavne demografske značilnosti v TURQUOISE-III
MARKETING AUTHORISATION NUMBER(S) EU/1/14/983/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/983/001
You will take Exviera for either 12 or 24 weeks.
Zdravilo Exviera boste jemali bodisi 12 ali 24 tednov.
Component of a multipack, can't be sold separately.
Komponente večkratnega pakiranja se ne sme izdati posebej.
Changes in selected laboratory parameters are described in Table 4.
Spremembe izbranih laboratorijskih vrednosti so opisane v preglednici 4.
Limited data in patients with end-stage renal disease indicate no clinically significant changes in exposure also in this patient group.
Omejeni podatki pri bolnikih z ledvično odpovedjo ne kažejo nobenih klinično pomembnih sprememb pri izpostavitvi tudi pri tej skupini bolnikov.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 January 2015
Datum prve odobritve: 15.01.2015
25 mg once daily administered in the morning, with food
25 mg enkrat na dan zjutraj, s hrano
The recommended dose of dasabuvir is 250 mg (one tablet) twice daily (morning and evening).
Priporočeni peroralni odmerek dasabuvirja je 250 mg (ena tableta) dvakrat na dan (zjutraj in zvečer).
Co-administration of Exviera with other antivirals has not been studied and, therefore, cannot be recommended.
Exviera z drugimi protivirusnimi zdravili ni bila raziskana in je zato ni mogoče priporočati.
Drug interaction studies have only been performed in adults.
Pediatrična populacija Študije medsebojnega delovanja so bile izvedene le pri odraslih.
In case a dose of Exviera is missed, the prescribed dose can be taken within 6 hours.
Če bolnik izpusti odmerek zdravila Exviera, lahko predpisani odmerek vzame v 6 urah.
No (for any parameter listed above) *AFP= serum alpha fetoprotein
Da (za vse tri zgoraj naštete parametre) Ne (za kateri koli zgoraj našteti parameter) *AFP = alfa-fetoprotein v serumu
Pharmacotherapeutic group: Antivirals for systemic use; direct-acting antivirals, ATC code: J05AX16 Mechanism of action
Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje virusnih infekcij, zdravila z direktnim delovanjem na viruse, oznaka ATC: J05AX16
Peg-IFN + RBV, n (%) Baseline albumin, median g/L
Peg-IFN + RBV, n (%) Izhodiščni albumin, median g/L
Expected: ↓ esomeprazole, lansoprazole
Pričakovano: ↓ esomeprazol, lansoprazol
AFP* < 20 ng/mL, platelets ≥ 90 x 109/L, AND albumin ≥ 35 g/L prior to treatment
AFP* < 20 ng/ml, trombociti ≥ 90 x 109/l IN albumin ≥ 35 g/l pred zdravljenjem
The increase in exposure was similar regardless of meal type (e.g., high-fat versus moderate-fat) or calorie content (approximately 600 kcal versus approximately 1000 kcal).
Zvečanje izpostavljenosti je bilo podobno ne glede na vrsto obroka (npr. zelo masten obrok v primerjavi z zmerno mastnim) ali kalorično vrednost (približno 600 kcal v primerjavi s približno 1000 kcal).
Age, median (range) years Male gender, n (%) IL28B Non-CC genotype, n (%) Prior HCV Treatment:
Starost, mediana leta (razpon) Moški spol, n (%) IL28B ne-CC genotip, n (%) Predhodno zdravljenje za HCV: