natgillin/translations-raw huggingface dataset:
At baseline, 52% had advanced clinical stage (Rai Stage III or IV), 32% of patients had bulky disease (≥5 cm), 44% with baseline anemia, 22% with baseline thrombocytopenia, 28% had a CrCL <60 mL/min, and the median Cumulative Illness Rating Score for Geriatrics (CIRS-G) was 4 (range, 0 to 12).
Na početku ispitivanja 52% bolesnika imalo je uznapredovali klinički stadij bolesti (Rai stadij III ili IV), 32% bolesnika imalo je veliku tumorsku masu (≥ 5 cm), njih 44% je na početku ispitivanja imalo anemiju, a 22% trombocitopeniju, 28% bolesnika imalo je CrCL < 60 ml/min, a medijan rezultata na ljestvici za kumulativnu ocjenu bolesti u starijih bolesnika (engl.
Lymphocytosis
Limfocitoza
Each 140 mg film-coated tablet contains 28 mg of lactose monohydrate.
Pomoćne tvari s poznatim učinkom Jedna filmom obložena tableta od 140 mg sadrži 28 mg laktoze hidrata.
• blurred vision
• zamagljen vid
IMBRUVICA 280 mg film-coated tablets
IMBRUVICA 280 mg filmom obložene tablete
IMBRUVICA 280 mg film-coated tablets: Each tablet contains 280 mg of ibrutinib.
IMBRUVICA 280 mg filmom obložene tablete: jedna tableta sadrži 280 mg ibrutiniba.
The recommended dose for the treatment of MCL is 560 mg once daily.
MCL Preporučena doza za liječenje limfoma plaštenih stanica je 560 mg jedanput na dan.
Each 420 mg film-coated tablet contains 84 mg of lactose monohydrate.
Pomoćne tvari s poznatim učinkom Jedna filmom obložena tableta od 420 mg sadrži 84 mg laktoze hidrata.
Yellow-green to green oblong tablets (17.5 mm in length and 7.4 mm in width), written with “ibr” on one side and “420” on the other side.
Žutozelene do zelene duguljaste tablete (17,5 mm dužine i 7,4 mm širine), s „ibr” ispisanim na jednoj strani i „420” na drugoj strani.
IMBRUVICA 420 mg film-coated tablets Each film-coated tablet contains 420 mg of ibrutinib.
IMBRUVICA 420 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 420 mg ibrutiniba.
Yellow-green to green oblong tablets (17.5 mm in length and 7.4 mm in width), debossed with “ibr” on one side and “420” on the other side.
Žutozelene do zelene duguljaste tablete (dužine 17,5 mm i širine 7,4 mm), s utisnutim „ibr” na jednoj strani i „420” na drugoj strani.
NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg hard capsules
IMBRUVICA 140 mg tvrde kapsule
IMBRUVICA 280 mg film-coated tablets Each film-coated tablet contains 280 mg of ibrutinib.
IMBRUVICA 280 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 280 mg ibrutiniba.
Urticaria Erythema Onychoclasis
Prijavljivanje nuspojava
Purple oblong tablets (15 mm in length and 7 mm in width), debossed with “ibr” on one side and “280” on the other side.
Ljubičaste duguljaste tablete (dužine 15 mm i širine 7 mm), s utisnutim „ibr” na jednoj strani i „280” na drugoj strani.
Subdural haematoma
Manje često Subduralni hematom
Yellow to orange oblong tablets (19 mm in length and 8.1 mm in width), debossed with “ibr” on one side and “560” on the other side.
Žute do narančaste duguljaste tablete (dužine 19 mm i širine 8,1 mm), s utisnutim „ibr” na jednoj strani i „560” na drugoj strani.
Cases of progressive multifocal leukoencephalopathy (PML) including fatal ones have been reported following the use of ibrutinib within the context of a prior or concomitant immunosuppressive therapy.
Nakon primjene ibrutiniba uz prethodno ili konkomitantno imunosupresivno liječenje, prijavljeni su slučajevi progresivne multifokalne leukoencefalopatije (PML), uključujući i one sa smrtnim ishodom.
Each 280 mg film-coated tablet contains 56 mg of lactose monohydrate.
Pomoćne tvari s poznatim učinkom Jedna filmom obložena tableta od 280 mg sadrži 56 mg laktoze hidrata.
• Tablet film-coat: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171); IMBRUVICA 140 mg and IMBRUVICA 420 mg film-coated tablets also contain black iron oxide (E172) and yellow iron oxide (E172); IMBRUVICA 280 mg film-coated tablets also contain black iron oxide (E172) and red iron oxide (E172); IMBRUVICA 560 mg film-coated tablets also contain red iron oxide (E172) and yellow iron oxide (E172).
Jezgra tablete: koloidni, bezvodni silicijev dioksid, umrežena karmelozanatrij, laktoza hidrat (vidjeti dio 2 „IMBRUVICA sadrži laktozu“), magnezijev stearat, mikrokristalična celuloza, povidon, natrijev laurilsulfat (E487) Film ovojnica tablete: poli(vinilni alkohol), makrogol, talk, titanijev dioksid (E171) IMBRUVICA 140 mg i IMBRUVICA 420 mg filmom obložene tablete također sadrže crni željezov oksid (E172) i žuti željezov oksid (E172);
Non-melanoma skin cancers were reported more frequently in patients treated with IMBRUVICA than in patients treated with comparators in pooled comparative randomised phase 3 studies.
U objedinjenim komparativnim, randomiziranim ispitivanjima faze 3, prijavljen je nemelanomski rak kože s većom učestalošću u bolesnika liječenih lijekom IMBRUVICA nego u bolesnika liječenih poredbenim lijekovima.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 420 MG TABLET (30 days)
OMOT 420 MG TABLETE (30 dana)
The recommended dose for the treatment of MCL is 560 mg (four capsules) once daily.
MCL Preporučena doza za liječenje limfoma plaštenih stanica je 560 mg (četiri kapsule) jedanput na dan.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 560 MG TABLET (30 days)
OMOT 560 MG TABLETE (30 dana)
Eighty-one percent of patients had a baseline ECOG performance status of 0 or 1, and 19% had a baseline ECOG performance status of 2.
Na početku ispitivanja 81% bolesnika imalo je ECOG funkcionalni status 0 ili 1, dok je njih 19% imalo ECOG funkcionalni status 2. Medijan broja prethodnih terapija iznosio je 4 (raspon: 1 do 7 terapija).
The median age was 69 years (range, 36 to 89 years), 66% were male, and 79% were Caucasian.
Medijan dobi iznosio je 69 godina (raspon: 36 do 89 godina), 66% ispitanika bili su muškarci, a 79% bijelci.
• Tablet core: colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate (see section 2 “IMBRUVICA contains lactose”), magnesium stearate, microcrystalline cellulose, povidone, sodium lauril sulfate (E487).
Jezgra tablete silicijev dioksid, koloidni, bezvodni karmelozanatrij, umrežena laktoza hidrat magnezijev stearat celuloza, mikrokristalična povidon natrijev laurilsulfat (E487)
The safety and efficacy of IMBRUVICA in patients with treatment naïve CLL/SLL were further evaluated in a randomized, multi-center, open-label, Phase 3 study (PCYC-1130-CA) of IMBRUVICA in combination with obinutuzumab versus chlorambucil in combination with obinutuzumab.
Sigurnost i djelotvornost lijeka IMBRUVICA dodatno su se ocjenjivale u randomiziranom, multicentričnom, otvorenom ispitivanju faze 3 (PCYC-1130-CA) provedenom u prethodno neliječenih bolesnika s KLL-om/LMS-om koji su primali lijek IMBRUVICA u kombinaciji s obinutuzumabom ili klorambucil u kombinaciji s obinutuzumabom.
Study PCYC-1127-CA had a separate monotherapy arm of 31 patients with previously treated WM who failed prior rituximab-containing therapy and received single agent IMBRUVICA.
Obuhvaćala je 31 bolesnika s prethodno liječenim WM-om koji nisu odgovorili na prethodnu terapiju koja je sadržavala rituksimab i koji su primali lijek IMBRUVICA u monoterapiji.
Figure 5: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1130-CA
Slika 5: Kaplan-Meierova krivulja PFS-a (ITT populacija) u ispitivanju PCYC-1130-CA
How to take IMBRUVICA
KAKO UZIMATI LIJEK IMBRUVICA
HOW TO TAKE IMBRUVICA
Kako uzimati lijek IMBRUVICA
• liver failure
• zatajenje jetre
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 560 MG TABLET (28 days)
OMOT 560 MG TABLETE (28 dana)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 280 MG TABLET (30 days)
OMOT 280 MG TABLETE (30 dana)
NAME OF THE MEDICINAL PRODUCT IMBRUVICA 560 mg tablets ibrutinib
IMBRUVICA 560 mg tablete ibrutinib
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 420 MG TABLET (28 days)
OMOT 420 MG TABLETE (28 dana)
PHARMACEUTICAL FORM AND CONTENTS 14 film-coated tablets
14 filmom obloženih tableta
Figure 6: Kaplan-Meier curve of PFS (ITT Population) in Study PCYC-1112- CA
Slika 6: Kaplan-Meierova krivulja PFS-a (ITT populacija) u ispitivanju PCYC-1112- CA
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 280 MG TABLET (28 days)
OMOT 280 MG TABLETE (28 dana)
NAME OF THE MEDICINAL PRODUCT IMBRUVICA 420 mg tablets ibrutinib
IMBRUVICA 420 mg tablete ibrutinib
• back pain or joint pain
• bol u leđima ili zglobovima
The CR rate according to IWCLL criteria was 16.2% in the IMBRUVICA arm versus 3.0% in the chlorambucil arm. At the time of long-term follow-up, a total of 73 subjects (54.9%) originally randomized to the chlorambucil arm subsequently received ibrutinib as cross-over treatment.
Stopa potpunog odgovora prema kriterijima IWCLL-a iznosila je 16,2% u skupini liječenoj lijekom IMBRUVICA te 3,0% u onoj koja je primala klorambucil.
Response Rate (CR, VGPR, PR) Median duration of response, months (range)
Stopa odgovora (CR, VGPR, PR)
Cases of leukostasis have been reported in patients treated with IMBRUVICA.
U bolesnika liječenih lijekom IMBRUVICA prijavljeni su slučajevi leukostaze.
NAME OF THE MEDICINAL PRODUCT IMBRUVICA 280 mg tablets ibrutinib
IMBRUVICA 280 mg tablete ibrutinib
The dose of ibrutinib should be reduced to 280 mg once daily (two capsules) when used concomitantly with moderate CYP3A4 inhibitors.
Kada se uzima istodobno s umjerenim CYP3A4 inhibitorima, doza ibrutiniba mora se sniziti na 280 mg jedanput na dan (dvije kapsule).
Purple oblong (15 mm in length and 7 mm in width), written with “ibr” on one side and “280” on the other side.
Ljubičaste duguljaste tablete (15 mm dužine i 7 mm širine), s „ibr” ispisanim na jednoj strani i „280” na drugoj strani.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 140 MG TABLET (30 days)
OMOT 140 MG TABLETE (30 dana)
NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg tablets ibrutinib
IMBRUVICA 140 mg tablete ibrutinib
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 140 MG TABLET (28 days)
OMOT 140 MG TABLETE (28 dana)
NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg film-coated tablets ibrutinib
IMBRUVICA 140 mg filmom obložene tablete ibrutinib
Warfarin or other vitamin K antagonists should not be administered concomitantly with IMBRUVICA.
Varfarin ili drugi antagonisti vitamina
NAME OF THE MEDICINAL PRODUCT IMBRUVICA 420 mg film-coated tablets ibrutinib
IMBRUVICA 420 mg filmom obložene tablete ibrutinib
Per IRC.
Via C.
Chronic lymphocytic leukaemia (CLL)/Waldenström's macroglobulinaemia (WM) The recommended dose of IMBRUVICA is three capsules (420 mg) once a day.
Preporučena doza za liječenje Waldenströmove makroglobulinemije je 420 mg (tri kapsule) jedanput na dan.
The recommended dose for the treatment of WM is 420 mg once daily.
Preporučena doza za liječenje Waldenströmove makroglobulinemije je 420 mg jedanput na dan.
Others
DRUGO
QUALITATIVE AND QUANTITATIVE COMPOSITION IMBRUVICA 140 mg film-coated tablets Each film-coated tablet contains 140 mg of ibrutinib.
IMBRUVICA 140 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 140 mg ibrutiniba.
The dose of ibrutinib should be reduced to 280 mg once daily when used concomitantly with moderate CYP3A4 inhibitors.
Kada se uzima istodobno s umjerenim CYP3A4 inhibitorima, doza ibrutiniba mora se sniziti na 280 mg jedanput na dan.
EU/1/14/945/007 - 28 tablets (2 wallet packs of 14) EU/1/14/945/008 - 30 tablets (3 wallet packs of 10)
EU/1/14/945/007 - 28 tableta (2 pakiranja omota s po 14) EU/1/14/945/008 - 30 tableta (3 pakiranja omota s po 10)
NAME OF THE MEDICINAL PRODUCT IMBRUVICA 560 mg film-coated tablets ibrutinib
IMBRUVICA 560 mg filmom obložene tablete ibrutinib
At baseline, the median serum IgM value was 3.2 g/dL (range, 0.6 to 8.3 g/dL), 63% of patients were anaemic (haemoglobin ≤11 g/dL or 6.8 mmol/L) and MYD88 L265P mutations were present in 77% of patients, absent in 13% of patients, and 9% of patients were not evaluable for mutation status.
Na početku ispitivanja medijan serumske vrijednosti IgM iznosio je 3,2 g/dl (raspon: 0,6 do 8,3 g/dl), 63% bolesnika imalo je anemiju (hemoglobin ≤ 11 g/dl ili 6,8
How to store IMBRUVICA
Kako čuvati lijek IMBRUVICA
Stomatitis
IMBRUVICA
NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg capsules ibrutinib
IMBRUVICA 140 mg kapsule ibrutinib
Figure 3: Kaplan-Meier curve of OS (ITT Population) in Study PCYC-1115-CA
Slika 3: Kaplan-Meierova krivulja OS-a (ITT populacija) u ispitivanju PCYC-1115-CA
Figure 2: Kaplan-Meier curve of PFS (ITT Population) in Study PCYC-1115-CA
Slika 2: Kaplan-Meierova krivulja PFS-a (ITT populacija) u ispitivanju PCYC-1115-CA
NAME OF THE MEDICINAL PRODUCT IMBRUVICA 280 mg film-coated tablets ibrutinib
IMBRUVICA 280 mg filmom obložene tablete ibrutinib
Ninety-three percent of patients had a baseline ECOG performance status of 0 or 1, and 7% of patients had a baseline ECOG performance status of 2.
Na početku ispitivanja 93% bolesnika imalo je ECOG funkcionalni status 0 ili 1, dok je njih 7% imalo ECOG funkcionalni status 2. Četrdeset i pet posto (45%) bolesnika prethodno nije primalo liječenje, dok je njih 55% bilo prethodno liječeno.
EU/1/14/945/012 - 28 tablets (2 wallet packs of 14) EU/1/14/945/006 - 30 tablets (3 wallet packs of 10)
EU/1/14/945/012 - 28 tableta (2 pakiranja omota s po 14) EU/1/14/945/006 - 30 tableta (3 pakiranja omota s po 10)
: +359 2 489 94 00 jjsafety@its.jnj.com
България „Джонсън & Джонсън България” ЕООД Тел.: +359 2 489 94 00 jjsafety@its.jnj.com
EU/1/14/945/011 - 28 tablets (2 wallet packs of 14) EU/1/14/945/005 - 30 tablets (3 wallet packs of 10)
EU/1/14/945/011 - 28 tableta (2 pakiranja omota s po 14) EU/1/14/945/005 - 30 tableta (3 pakiranja omota s po 10)
See package leaflet for further information.
Za dodatne informacije vidjeti uputu o lijeku.
Bulky disease <5 cm
Broj prethodnih linija liječenja velika tumorska masa < 5 cm
Tel.: +386 1 401 18 00
Johnson & Johnson d.o.o. Tel.: +386 1 401 18 00
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 140 mg of ibrutinib
Jedna filmom obložena tableta sadrži 140 mg ibrutiniba
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 560 mg of ibrutinib
Jedna filmom obložena tableta sadrži 560 mg ibrutiniba
Metabolism
Monoterapija
Refractory disease to purine analog Yes
Svi ispitanici Delecija 17p Da Ne Bolest refraktorna na analoge purina Da Ne Dob
The updated Kaplan-Meier curve for PFS is shown in Figure 7.
Na Slici 7 prikazana je ažurirana Kaplan-Meierova krivulja PFS-a.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 420 mg of ibrutinib
Jedna filmom obložena tableta sadrži 420 mg ibrutiniba
EU/1/14/945/008 (30 tablets)
EU/1/14/945/007 (28 tableta) EU/1/14/945/008 (30 tableta)
d.o.o.
PRILOG II.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 280 mg of ibrutinib
Jedna filmom obložena tableta sadrži 280 mg ibrutiniba
Very common Headache Common
Teška bolest srca
Hazard Ratio
Rai stadij
• inflammation of the fatty tissue underneath the skin
• upala potkožnog masnog tkiva
EU/1/14/945/010 (30 tablets)
EU/1/14/945/009 (28 tableta) EU/1/14/945/010 (30 tableta)
Titanium dioxide (E171) Black iron oxide (E172) Red iron oxide (E172)
IMBRUVICA 280 mg filmom obložene tablete makrogol poli(vinilni alkohol) talk titanijev dioksid (E171) željezov oksid, crni (E172) željezov oksid, crveni (E172)
ECOG per CRF
ECOG funkcionalni status prema test listi ispitanika (CRF)
Talc
tkiva
The updated Kaplan-Meier curve for PFS is shown in Figure 4.
Na Slici 4 prikazana je ažurirana Kaplan-Meierova krivulja PFS-a.
Onychoclasis
Onihoklazija
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 140 MG CAPSULE
VANJSKA KUTIJA 140 MG KAPSULE
Single agent
Starije osobe
Cases of ILD have been reported in patients treated with IMBRUVICA.
U bolesnika koji su liječeni lijekom IMBRUVICA prijavljeni su slučajevi intersticijske bolesti pluća.
Tumour lysis syndrome Hyperuricaemia Nervous system disorders Very common Headache Common
Poremećaji živčanog sustava Vrlo često Glavobolja
Janssen-Cilag Polska Sp. z o.o.
Janssen-Cilag B.V.
Progression free survival (PFS) as assessed by IRC indicated an 80% statistically significant reduction in the risk of death or progression in the IMBRUVICA arm. Efficacy results for Study PCYC-1127CA are shown in Table 11 and the Kaplan-Meier curve for PFS is shown in Figure 8.
Preživljenje bez progresije bolesti (PFS) prema ocjeni IRC-a ukazalo je na statistički značajno smanjenje rizika od smrti ili progresije bolesti za 80% u skupini koja je primala lijek IMBRUVICA.
Angioedema Panniculitis
Krvožilni poremećaji
discontinue IMBRUVICA
prekinite primjenu lijeka IMBRUVICA
Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172)
IMBRUVICA 560 mg filmom obložene tablete makrogol poli(vinilni alkohol) talk titanijev dioksid (E171) željezov oksid, crveni (E172) željezov oksid, žuti (E172)
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 140 MG TABLET
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP
A cycle lasts 3 weeks.
Ciklus traje 3 tjedna.
This means that it changes the activity of the immune system (the body's natural defences).
To znači da mijenja aktivnost imunosnog sustava (prirodne obrane organizma).
This can increase the length of time the patient stays in remission.
To može povećati vrijeme koje bolesnik ostaje u remisije.
Every year, the Agency will review any new information that may become available and this summary will be updated as necessary.
Svake godine Agencija će procijeniti sve nove informacije koje postanu dostupne te će se ovaj sažetak po potrebi ažurirati.
This overview was last updated in 07-2018.
Ovaj pregled informacija posljednji je put ažuriran u 7. 2018.
Histamine is a substance occurring naturally in the body that is involved in many processes.
Histamin je tvar koja prirodno nastaje u tijelu i sudjeluje u mnogim procesima.
Ceplene has been authorised under ‘exceptional circumstances'.
Lijek Ceplene je odobren u „iznimnim okolnostima”.
It is used during the patients' first ‘remission' (a period without symptoms of the disease after the first course of treatment).
Koristi se tijekom bolesnikove prve „remisije” (razdoblje bez simptoma bolesti nakon prvog liječenja).
Between each cycle there should be a treatment-free period of 3 weeks.
Između svakog ciklusa mora biti razdoblje od 3 tjedna bez liječenja.
What is Ceplene and what is it used for?
Što je Ceplene i za što se koristi?
What measures are being taken to ensure the safe and effective use of Ceplene?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ceplene?
Further information on Ceplene can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Više informacija o lijeku Ceplene nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Other information about Ceplene
Ostale informacije o lijeku Ceplene
An overview of Ceplene and why it is authorised in the EU
Pregled informacija o lijeku Ceplene i zašto je odobren u EU-u
This is because it has not been possible to obtain complete information about Ceplene due to the rarity of the disease.
Razlog tome je nemogućnost dobivanja potpunih informacija o lijeku Ceplene zbog male učestalosti bolesti.
When Ceplene is first given, the patient's blood pressure, heart rate and lung function must be checked.
Kada se lijek Ceplene primjenjuje prvi put, mora se provjeriti bolesnikov krvni tlak, srčana frekvencija i funkcija pluća.
The recommended dose of Ceplene is one injection twice a day, one to three minutes after an interleukin-2 injection.
Preporučena doza lijeka Ceplene je jedna injekcija dvaput na dan, jednu do tri minute nakon injekcije interleukina-2.
Ceplene must not be used in patients who have severe heart problems or in women who are pregnant or breastfeeding.
Ceplene se ne smije primjenjivati u bolesnika koji imaju teške probleme sa srcem ili u žena tijekom trudnoće ili dojenja.
AML is rare, and Ceplene was designated an ‘orphan medicine' (a medicine used in rare diseases) on 11 April 2005.
AML je rijetka bolest, a Ceplene je dobio status „lijeka za rijetku bolest” 11. travnja 2005.
Ceplene (histamine dihydrochloride)
Ceplene (histamin dihidroklorid)
Depending on the patient's response to treatment and side effects, the treatment may have to be suspended or the dose adjusted.
Ovisno o bolesnikovom reagiranju na liječenje i nuspojavama, možda će trebati prekinuti liječenje ili prilagoditi dozu.
For patients who were into their first remission the combination of Ceplene and interleukin-2 was more effective than no treatment in increasing the time until AML came back or the patient died from any cause: the average time without disease increased from 291 days with no treatment to 450 days after treatment with Ceplene and interleukin-2.
Za bolesnike koji su bili u svojoj prvoj remisiji kombinacija lijekova Ceplene i interleukin-2 bila je učinkovitija nego neuzimanje terapije u produljenju vremena do povratka AML-a ili smrti bolesnika od bilo kojeg uzroka: prosječno vrijeme bez bolesti povećano je s 291 dan bez terapije na 450 dana nakon liječenja lijekovima Ceplene i interleukin-2.
Side effects reported with Ceplene are carefully evaluated and any necessary action taken to protect patients.
Nuspojave prijavljene za lijek Ceplene pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
What are the risks associated with Ceplene?
Koji su rizici povezani s lijekom Ceplene?
This improves the effectiveness of interleukin-2, a medicine that stimulates the immune system to attack cancerous cells.
To poboljšava učinkovitost interleukina-2, lijeka koji stimulira imunosni sustav da napada stanice raka.
The European Medicines Agency decided that Ceplene's benefits are greater than its risks and it can be authorised for use in the EU.
Europska agencija za lijekove zaključila je da koristi od lijeka Ceplene nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
Ceplene received a marketing authorisation valid throughout the EU on 7 October 2008.
Lijek Ceplene dobio je odobrenje za stavljanje lijeka u promet koje vrijedi na prostoru EU-a od 7. listopada 2008.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ceplene have been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Ceplene nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
Patients can inject themselves once they have been trained appropriately.
Bolesnici se mogu sami injicirati kada ih se osposobi za to.
Each Ceplene injection must be given slowly over five to 15 minutes, in a different site from the interleukin-2 injection, and preferably in the thigh or abdomen (belly).
Svaka injekcija lijeka Ceplene mora se primjenjivati polagano tijekom 5 do 15 minuta, na različito mjesto od injekcije interleukina-2, a po mogućnosti u bedro ili abdomen (trbuh).
The effectiveness of Ceplene has been studied in one main study involving 320 adults with AML who were in remission following leukaemia treatment.
Učinkovitost lijeka Ceplene ispitivana je u jednoj glavnoj studiji koja je obuhvatila 320 odraslih osoba s AML-om koje su bile u remisiji nakon liječenja leukemije.
It must also not be used in patients who have received a bone marrow transplant from a donor, or who are taking steroids (medicines used to reduce or prevent inflammation) given systemically (given by mouth or by injection), clonidine (used to reduce high blood pressure) or histamine H2 blockers (used to treat stomach ulcers, indigestion or heartburn).
Također se ne smije primjenjivati u bolesnika kojima je presađena koštana srž od donora ili koji uzimaju steroide (lijekove koji se upotrebljavaju za smanjenje ili sprječavanje upale) primijenjene sistemski (kroz usta ili injekcijom), klonidin (upotrebljava se za snižavanje visokog krvnog tlaka) ili histamin H2 blokatore (upotrebljava se za liječenje čireva na želucu, probavnih tegoba ili žgaravice).