natgillin/translations-raw huggingface dataset:
Levetiracetam Teva 250 mg film-coated tablets Levetiracetam Teva 500 mg film-coated tablets Levetiracetam Teva 750 mg film-coated tablets Levetiracetam Teva 1000 mg film-coated tablets
Levetiracetam Teva 250 mg filmom obložene tablete Levetiracetam Teva 500 mg filmom obložene tablete Levetiracetam Teva 750 mg filmom obložene tablete Levetiracetam Teva 1000 mg filmom obložene tablete
Rare: may affect up to 1 in 1,000 people • infection;
Rijetko: mogu se javiti u manje od 1 na 1000 ljudi
CLcr (ml/min) = [140-age(years)] x weight (kg)_ (x 0.85 for women)
[140 - dob (godine)] x težina (kg)
• skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (StevensJohnson syndrome), and a more severe form causing skin peeling in more than 30 % of the body surface (toxic epidermal necrolysis).
jako rasprostranjen osip s mjehurma i kožom koja se ljušti, osobito oko usta, nosa, očiju i genitalija (Stevens-Johnsonov sindrom), i mnogo teži oblik koji uzrokuje ljuštenje kože na više od 30% površine tijela (toksična epidermalna nekroliza).
• convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness),
• konvulzije, poremećaj ravnoteže, omaglica (osjećaj nestabilnosti), letargija (nedostatak energije i elana), tremor (nevoljno drhtanje);
Infants 6 to 23 months, children and adolescents weighing less than 50 kg
mjeseca, djeca i adolescenti tjelesne težine manje od 50 kg
Respiratory,
Mišićna slabost,
Tablet coating: hypromellose 6 cp, titanium dioxide (E171), macrogol 3350, colourants*
Ovojnica tablete: hipromeloza 6 cp, titanijev dioksid (E171), makrogol 3350, bojila*
Contact your doctor if you took more tablets than you should.Your doctor will establish the best possible treatment of overdose.
Vaš će liječnik odrediti najbolji mogući način liječenja predoziranja.
Convulsion, balance disorder, dizziness, lethargy, tremor
omaglica, letargija, tremor
• in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy.
parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih, adolescenata, djece i dojenčadi od prvog mjeseca života;
Levetiracetam Teva 1000 mg film-coated tablets Each film-coated tablet contains 1000 mg levetiracetam.
Levetiracetam Teva 1000 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 1000 mg levetiracetama.
An oral solution is the formulation to use in infants.
Oralna otopina je farmaceutski oblik za primjenu u dojenčadi.
Hypromellose 6 cp, Titanium dioxide (E171), Macrogol 3350, Indigotine (E132), Brilliant blue FCF (E133)
Levetiracetam Teva 250 mg filmom obložene tablete hipromeloza 6 cp, titanijev dioksid (E171), makrogol 3350, indigotin (E132), brilliant blue FCF (E133)
With continued long-term treatment, 28.6 % of the patients were free of myoclonic seizures for at least 6 months and 21.0 % were free of myoclonic seizures for at least 1 year.
28,6% bolesnika bilo je barem 6 mjeseci i 21,0% barem 1 godinu bez miokloničkih napadaja.
750 mg film-coated tablets: iron oxide yellow (E172), iron oxide red (E172) and sunset yellow FCF (E110).
500 mg filmom obložene tablete: indigotin (E132), tartrazin (E102) i žuti željezov oksid (E 172). 750 mg filmom obložene tablete: žuti željezov oksid (E 172), crveni željezov oksid (E172) i sunset yellow FCF (E110).
35 infants aged less than 1 year with partial onset seizures have been exposed in placebo-control clinical studies of which only 13 were aged < 6 months.
1 godine s parcijalnim napadajima, a samo je njih 13 bilo u dobi < 6 mjeseci.
Hypromellose 6 cp, Titanium dioxide (E171), Macrogol 3350, Iron oxide yellow (E172), Iron oxide red (E172), Sunset yellow FCF (E110)
Levetiracetam Teva 750 mg filmom obložene tablete hipromeloza 6 cp, titanijev dioksid (E171), makrogol 3350, željezov oksid, žuti (E172), željezov oksid, crveni (E172), sunset yellow FCF (E110)
Levetiracetam Teva 250 mg film-coated tablets Each film-coated tablet contains 250 mg levetiracetam.
Levetiracetam Teva 250 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 250 mg levetiracetama.
Abdominal pain, diarrhoea, dyspepsia, vomiting, nausea
Bol u trbuhu, dijareja, dispepsija,
Levetiracetam Teva 1000 mg film-coated tablets EU/1/11/701/022
Levetiracetam Teva 1000 mg filmom obložene tablete EU/1/11/701/022
Croscarmellose sodium Magnesium stearate
Jezgra tablete kukuruzni škrob povidon karmelozanatrij, umrežena magnezijev stearat
Linear and dose proportional increases were observed for peak plasma concentrations and area under the curve.
Za vršne koncentracije u plazmi i površinu ispod krivulje primijećena su linearna povećanja proporcionalna s dozom.
3.5 to 7 mg/kg twice daily
3,5 do 7 mg/kg dva puta na dan
Levetiracetam Teva 250 mg film-coated tablets EU/1/11/701/001
Levetiracetam Teva 250 mg filmom obložene tablete EU/1/11/701/001
Suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination, anger, confusional state , panic attack, affect lability/mood swings, agitation
halucinacije, srditost, konfuzno stanje, napadaj panike labilnost afekta/promjene raspoloženja, agitacija
Levetiracetam Teva 750 mg film-coated tablets EU/1/11/701/015
Levetiracetam Teva 750 mg filmom obložene tablete EU/1/11/701/015
7 to 14 mg/kg twice daily
7 do 14 mg/kg dva puta na dan
10 to 20 mg/kg twice daily
10 do 20 mg/kg dva puta na dan
Common: may affect up to 1 in 10 people
Često: mogu se javiti u manje od 1 na 10 ljudi
Levetiracetam Teva 500 mg film-coated tablets EU/1/11/701/008
Levetiracetam Teva 500 mg filmom obložene tablete EU/1/11/701/008
Debossed with "7285" on the other side of the tablet.
Oznaka „7285“ utisnuta je na drugoj strani tablete.
7 to 21 mg/kg twice daily
7 do 21 mg/kg dva puta na dan
Debossed with "7287" on the other side of the tablet.
Oznaka „7287“ utisnuta je na drugoj strani tablete.
Uncommon: may affect up to 1 in 100 people
Manje često: mogu se javiti u manje od 1 na 100 ljudi
(1) A 750 mg loading dose is recommended on the first day of treatment with levetiracetam.
500 do 1000 mg jedanput na dan (2) (1) Prvog dana liječenja levetiracetamom preporučuje se udarna doza od 750 mg.
Debossed with "7286" on the other side of the tablet.
Oznaka „7286“ utisnuta je na drugoj strani tablete.
Pancytopenia, neutropenia, agranulocytosis
Pancitopenija neutropenija, agranulocitoza
Levetiracetam Teva 750 mg film-coated tablets
Levetiracetam Teva 750 mg filmom obložene tablete
Levetiracetam Teva 750 mg film-coated tablets levetiracetam
Levetiracetam Teva 750 mg filmom obložene tablete levetiracetam
CLcr (ml/min/1.73 m2 = Height (cm) x ks____
Visina (cm) x ks CLcr (ml/min/1,73 m2) = --------------------------------------Kreatinin u serumu (mg/dl)
Hypromellose 6 cp, Titanium dioxide (E171), Macrogol 3350, Indigotine (E132), Tartrazine (E102), Iron oxide yellow (E172)
Levetiracetam Teva 500 mg filmom obložene tablete hipromeloza 6 cp, titanijev dioksid (E171), makrogol 3350, indigotin (E132), tartrazin (E102), željezov oksid, žuti (E 172)
10 to 30 mg/kg twice daily
10 do 30 mg/kg dva puta na dan
5 to 15 mg/kg twice daily
5 do 15 mg/kg dva puta na dan
Levetiracetam Teva 1,000 mg film-coated tablets levetiracetam
Levetiracetam Teva 1000 mg filmom obložene tablete levetiracetam
(2)A 10.5 mg/kg loading dose is recommended on the first day of treatment with levetiracetam.
(2)Prvog dana liječenja levetiracetamom preporučuje se udarna doza od 10,5 mg/kg. (3)Prvog dana liječenja levetiracetamom preporučuje se udarna doza od 15 mg/kg. (4)Nakon dijalize preporučuje se dodatna doza od 3,5 do 7 mg/kg. (5)Nakon dijalize preporučuje se dodatna doza od 5 do 10 mg/kg.
Levetiracetam Teva 250 mg film-coated tablets
Levetiracetam Teva 250 mg filmom obložene tablete
500 to 1,000 mg twice daily
500 do1000 mg dva puta na dan
Orange, oblong shaped, film-coated tablets, scored on one side and debossed with "9" on one side of the score and with "3" on the other side of the score.
Narančaste, duguljaste, filmom obložene tablete s urezom na jednoj strani tablete te utisnutom oznakom „9“ s jedne i „3“ s druge strane ureza.
Levetiracetam Teva 1,000 mg film-coated tablets
Levetiracetam Teva 1000 mg filmom obložene tablete
3.5 to 10.5 mg/kg twice daily
3,5 do 10,5 mg/kg dva puta na dan
Levetiracetam Teva 500 mg film-coated tablets levetiracetam
Levetiracetam Teva 500 mg filmom obložene tablete levetiracetam
5 to 10 mg/kg twice daily
5 do 10 mg/kg dva puta na dan
Add-on therapy for adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more
Dodatna terapija za odrasle (≥18 godina) i adolescente (12 do 17 godina) tjelesne težine 50 kg ili veće Početna terapijska doza iznosi 500 mg dva puta na dan.
• symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function
• simptome kao što je smanjen volumen mokraće, umor, mučninu, povraćanje, smetenost i oticanje u nogama, gležnjevima ili stopalima jer to može biti znak naglog smanjenja bubrežne funkcije • kožni osip koji može tvoriti mjehure i izgledati poput malih meta (središnje tamne mrlje okružene svijetlim područjem, s tamnim prstenom oko ruba) (multiformni eritem) • rasprostranjeni osip s mjehurićima i kožom koja se ljušti, posebice oko usta, nosa, očiju i genitalija (Stevens-Johnsonov sindrom)
500 to 1,500 mg twice daily
500 do1500 mg dva puta na dan
Levetiracetam Teva 250 mg film-coated tablets levetiracetam
Levetiracetam Teva 250 mg filmom obložene tablete levetiracetam
Levetiracetam Teva 500 mg film-coated tablets
Levetiracetam Teva 500 mg filmom obložene tablete
ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Nazivi i adrese proizvođača odgovornih za puštanje serije lijeka u promet
EU/1/11/701/003 EU/1/11/701/004 EU/1/11/701/005 EU/1/11/701/006 EU/1/11/701/007 EU/1/11/701/029
EU/1/11/701/007 EU/1/11/701/029
Tartrazine
mijalgija
EU/1/11/701/022 30 film-coated tablets EU/1/11/701/023 50 film-coated tablets EU/1/11/701/024 50x1 film-coated tablet EU/1/11/701/025 60 film-coated tablets EU/1/11/701/026 100 film-coated tablets EU/1/11/701/027 120 film-coated tablets EU/1/11/701/028 200 film-coated tablets EU/1/11/701/032 20 film-coated tablets
EU/1/11/701/022 30 filmom obloženih tableta EU/1/11/701/023 50 filmom obloženih tableta EU/1/11/701/024 50x1 filmom obložena tableta EU/1/11/701/025 60 filmom obloženih tableta EU/1/11/701/026 100 filmom obloženih tableta EU/1/11/701/027 120 filmom obloženih tableta EU/1/11/701/028 200 filmom obloženih tableta EU/1/11/701/032 20 filmom obloženih tableta
Levetiracetam Teva may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy.
Ako vozite ili upravljate alatima ili vozilima potreban je oprez jer se pri uzimanju Levetiracetama Teva može javiti osjećaj pospanosti.
EU/1/11/701/001 30 film-coated tablets EU/1/11/701/002 50 film-coated tablets EU/1/11/701/003 50x1 film-coated tablet EU/1/11/701/004 60 film-coated tablets EU/1/11/701/005 100 film-coated tablets EU/1/11/701/006 120 film-coated tablets EU/1/11/701/007 200 film-coated tablets EU/1/11/701/029 20 film-coated tablets
EU/1/11/701/001 30 filmom obloženih tableta EU/1/11/701/002 50 filmom obloženih tableta EU/1/11/701/003 50x1 filmom obložena tableta EU/1/11/701/004 60 filmom obloženih tableta EU/1/11/701/005 100 filmom obloženih tableta EU/1/11/701/006 120 filmom obloženih tableta EU/1/11/701/007 200 filmom obloženih tableta EU/1/11/701/029 20 filmom obloženih tableta
EU/1/11/701/008 30 film-coated tablets EU/1/11/701/009 50 film-coated tablets EU/1/11/701/010 50x1 film-coated tablet EU/1/11/701/011 60 film-coated tablets EU/1/11/701/012 100 film-coated tablets EU/1/11/701/013 120 film-coated tablets EU/1/11/701/014 200 film-coated tablets EU/1/11/701/030 20 film-coated tablets
EU/1/11/701/008 30 filmom obloženih tableta EU/1/11/701/009 50 filmom obloženih tableta EU/1/11/701/010 50x1 filmom obložena tableta EU/1/11/701/011 60 filmom obloženih tableta EU/1/11/701/012 100 filmom obloženih tableta EU/1/11/701/013 120 filmom obloženih tableta EU/1/11/701/014 200 filmom obloženih tableta EU/1/11/701/030 20 filmom obloženih tableta
EU/1/11/701/015 30 film-coated tablets EU/1/11/701/016 50 film-coated tablets EU/1/11/701/017 50x1 film-coated tablet EU/1/11/701/018 60 film-coated tablets EU/1/11/701/019 100 film-coated tablets EU/1/11/701/020 120 film-coated tablets EU/1/11/701/021 200 film-coated tablets EU/1/11/701/031 20 film-coated tablets
EU/1/11/701/015 30 filmom obloženih tableta EU/1/11/701/016 50 filmom obloženih tableta EU/1/11/701/017 50x1 filmom obložena tableta EU/1/11/701/018 60 filmom obloženih tableta EU/1/11/701/019 100 filmom obloženih tableta EU/1/11/701/020 120 filmom obloženih tableta EU/1/11/701/021 200 filmom obloženih tableta EU/1/11/701/031 20 filmom obloženih tableta
Sími: + 354 5503300
Actavis Pharmaceutical Iceland ehf. Sími: + 354 5503300
72 x serum creatinine (mg/dl)
CLcr (ml/min) = ----------------------------------------------- (x 0,85 za žene) 72 x kreatinin u serumu (mg/dl)
Posology
PROMET
Yellow, oblong shaped, film coated tablets, scored on one side and debossed with "9" one side of the score and with "3" on the other side of the score.
Levetiracetam Teva 500 mg filmom obložene tablete Žute, duguljaste, filmom obložene tablete s urezom na jednoj strani tablete te utisnutom oznakom „9“ s jedne i „3“ s druge strane ureza.
It is available as tablets (5, 10, 15 and 20 mg).
Dostupan je u obliku tableta (5, 10, 15 i 20 mg).
However, the longterm effects of the medicine will need to be further investigated.
Međutim, dugoročne učinke lijeka potrebno je dodatno ispitati.
Jakavi is used to treat the following conditions:
Jakavi se koristi za liječenje sljedećih stanja:
The full EPAR for Jakavi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za lijek Jakavi nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Jakavi ruxolitinib
Jakavi ruksolitinib
If the treatment is not considered effective enough, the dose can be increased by 5 mg up to 25 mg twice a day.
Ako se liječenje ne smatra dovoljno djelotvornim, dozu je moguće povećati za 5 mg, do 25 mg dvaput dnevno.
Jakavi must not be used in women who are pregnant or breastfeeding.
Jakavi se ne smije koristiti u žena koje su trudne ili koje doje.
The European Commission granted a marketing authorisation valid throughout the European Union for Jakavi on 23 August 2012.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Jakavi na snazi u Europskoj uniji od 23. kolovoza 2012.
These blood cells migrate to organs including the spleen, causing them to become enlarged.
Te krvne stanice migriraju u organe, uključujući i slezenu, uzrokujući njihovo povećanje.
The main measure of effectiveness was the proportion of patients whose spleen had reduced in size by at least 35%, measured after six months in the first study and after one year in the second study.
Glavna mjera djelotvornosti bila je udio bolesnika čija se slezena smanjila za najmanje 35 %, mjereno nakon šest mjeseci u prvom ispitivanju i nakon godine dana u drugom ispitivanju.
Other information about Jakavi
Ostale informacije o lijeku Jakavi
What measures are being taken to ensure the safe and effective use of Jakavi?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Jakavi?
With regard to safety, the Committee considered that the risk of infections is acceptable but should be monitored further, while other known risks, such as bleeding or a reduction in blood cell counts, can be appropriately managed.
S obzirom na sigurnost, Odbor je smatrao da je rizik od infekcija prihvatljiv, ali da je potreban daljnji nadzor, dok se drugi poznati rizici, poput krvarenja ili smanjenja broja krvnih stanica, mogu kontrolirati na odgovarajući način.
This is a summary of the European public assessment report (EPAR) for Jakavi.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Jakavi.
In polycythaemia vera treatment should also be stopped when haemoglobin levels are very low.
Kod policitemije vere liječenje također treba prekinuti ako je razina hemoglobina vrlo niska.
In myelofibrosis, Jakavi was more effective than placebo and the best available treatment at reducing the size of the spleen.
U slučaju mijelofibroze, Jakavi je bio djelotvorniji od placeba i najbolje dostupne terapije u smanjivanju veličine slezene.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Jakavi.
Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke za uporabu lijeka Jakavi.
• myelofibrosis in adults who have splenomegaly (enlarged spleen) or symptoms related to the disease such as fever, night sweats, bone pain and weight loss.
• mijelofibroze u odraslih osoba koje imaju splenomegaliju (uvećanu slezenu) ili simptome povezane s tom bolešću poput vrućice, noćnih znojenja, bolova u kostima i gubitka težine.
Jakavi is a medicine that contains the active substance ruxolitinib.
Jakavi je lijek koji sadrži djelatnu tvar ruksolitinib.
For more information about treatment with Jakavi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Jakavi pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
What is Jakavi?
Što je Jakavi?
Treatment with Jakavi should only be started by a doctor who is experienced in treating patients with cancer medicines.
Liječenje lijekom Jakavi treba započeti samo liječnik iskusan u liječenju bolesnika s karcinomom.
In addition, the company that makes Jakavi is extending the main studies on myelofibrosis and will provide annual data on the effects of Jakavi in terms of how long patients live and how long they live without their disease getting worse or developing leukaemia.
Osim toga, tvrtka koja proizvodi Jakavi proširuje glavna ispitivanja o mijelofibrozi i osigurat će godišnje podatke o učincima lijeka Jakavi s obzirom na to kako dugo bolesnici preživljavaju i kako dugo žive bez pogoršanja bolesti ili razvoja leukemije.
The second study compared Jakavi with the best available treatment, which included different types of medicines such as anti-cancer agents, hormones and immunosuppressants.
Drugo je ispitivanje uspoređivalo lijek Jakavi s najboljom dostupnom terapijom koja je uključivala različite tipove lijekova poput lijekova protiv karcinoma, hormona i imunosupresiva.
Treatment should be stopped if the patient's blood levels of platelets or neutrophils (a type of white blood cell) fall below certain thresholds, or if no improvement in spleen size or symptoms is seen after six months.
Liječenje treba prekinuti ako razine trombocita i neutrofila (vrste bijelih krvnih stanica) u bolesnikovoj krvi padnu ispod određenog praga ili ako se ne uoči poboljšanje u veličini slezene ili u simptomima nakon 6 mjeseci.
In myelofibrosis, Jakavi was investigated in two main studies involving 528 patients.
U slučaju mijelofibroze, Jakavi je ispitivan u dva glavna ispitivanja koja su uključivala 528 bolesnika.
The active substance in Jakavi, ruxolitinib, works by blocking a group of enzymes known as Janus kinases (JAKs), which are involved in the production and growth of blood cells.
Djelatna tvar u lijeku Jakavi, ruksolitinib, djeluje blokirajući skupine enzima poznatih kao Janus kinaze (JAK-ovi) koji su uključeni u stvaranje i rast krvnih stanica.
A risk management plan has been developed to ensure that Jakavi is used as safely as possible.
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Jakavi.
The Committee noted that the quality of life of patients treated with Jakavi was improved but that the medicine's effects had still to be evaluated in terms of extending the life of patients or delaying the progress of the disease or the onset of leukaemia.
Odbor je primijetio da je kvaliteta života bolesnika liječenih lijekom Jakavi poboljšana, ali je još uvijek potrebno ocijeniti učinke lijeka u smislu produljenja života bolesnika ili odgode napredovanja bolesti ili nastupa leukemije.
In polycythaemia vera, the company will extend the main study to provide long-term data on the safety and effectiveness of Jakavi.
U slučaju policitemije vere, tvrtka će proširiti glavno ispitivanje kako bi osigurala dugoročne o podatke o sigurnosti primjene i djelotvornosti lijeka Jakavi.
Polycythaemia vera is a disease that mainly causes too many red blood cells to be produced, which can cause reduced blood flow to the organs due to ‘thickening' of the blood and occasionally the formation of blood clots.
Policitemija vera je bolest koja uglavnom uzrokuje stvaranje prekomjernog broja crvenih krvnih stanica, što može prouzročiti smanjeni dotok krvi u organe uslijed „zgušnjavanja” krvi i, ponekad, stvaranje krvnih ugrušaka.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Jakavi, including the appropriate precautions to be followed by healthcare professionals and patients.
Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi za lijek Jakavi nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
What is the risk associated with Jakavi?
Koji su rizici povezani s lijekom Jakavi?
By blocking JAKs, Jakavi reduces the abnormal production of blood cells, thereby reducing the symptoms of the diseases.
Blokirajući JAK-ove lijek Jakavi smanjuje abnormalno stvaranje krvnih stanica ublažujući na taj način simptome bolesti.
The patient's complete blood cell count must be taken before starting treatment and monitored during treatment.
Prije početka liječenja treba napraviti kompletnu krvnu sliku bolesnika i pratiti je tijekom liječenja.
Myelofibrosis is a disease in which the bone marrow becomes very dense and rigid and produces abnormal, immature blood cells.
Mijelofibroza je bolest kod koje koštana srž postane vrlo gusta i kruta te proizvodi abnormalne, nezrele krvne stanice.
In myelofibrosis the CHMP considered that the reduction in spleen size and symptoms seen in patients taking Jakavi is clinically important.
U slučaju mijelofibroze, CHMP je smatrao da su smanjenje veličine slezene i simptoma uočeni kod bolesnika koji uzimaju lijek Jakavi klinički važni.
In the first study, the target reduction in spleen size was achieved in 42% of patients treated with Jakavi (65 out of 155) compared with less than 1% of patients given placebo (1 out of 153).
U prvom ispitivanju ciljno smanjivanje veličine slezene postignuto je kod 42 % bolesnika liječenih lijekom Jakavi (65 od 155), u usporedbi s manje od 1 % bolesnika koji su primali placebo (1 od 153).
In polycythaemia vera, the recommended starting dose is 10 mg twice a day.
Preporučena početna doza kod policitemije vere je 10 mg dvaput dnevno.
In myelofibrosis, the recommended starting dose is up to 20 mg twice a day depending on the platelet count.
Preporučena početna doza kod mijelofibroze je do 20 mg dvaput dnevno ovisno o broju trombocita.
In polycythaemia vera the CHMP considered that Jakavi is of benefit to patients who do not respond or are intolerant to treatment with hydroxyurea, while the safety profile is acceptable.
U slučaju policitemije vere, CHMP je smatrao da lijek Jakavi koristi bolesnicima koji ne odgovaraju na terapiju hidroksiureom ili je ne podnose, a sigurnosni profil je prihvatljiv.