natgillin/translations-raw huggingface dataset:
Palpitations and cardiac extra beats, feeling sick (nausea), constipation, diarrhoea, abdominal pain, spinning sensation (vertigo), difficulty breathing (dyspnoea), muscle cramps, changes in laboratory parameters : high blood levels of uric acid, an excess of eosinophils (a type of white blood cell) and elevated creatinine in blood (a breakdown product of muscle), skin rash, angioedema (such as swollen face, tongue or throat, difficulty in breathing or swallowing), low blood pressure, fainting, feeling of tiredness, feeling of weakness, abnormal ECG heart tracing, double vision, impaired vision.
Osjećaj lupanja srca i neuobičajeni otkucaji srca, osjećaj slabosti (mučnina), zatvor, proljev, bol u trbuhu, osjećaj vrtnje (vrtoglavica), poteškoće u disanju (dispneja), grčevi u mišićima i promjene u laboratorijskim pretragama: visoka razina mokraćne kiseline u krvi, prekomjeran broj eozinofila (vrsta bijelih krvnih stanica) i povišena razina kreatinina u krvi (nastaje zbog raspada mišića), kožni osip,
Dyspnoea
Diplopija
Ivabradine does not influence intracardiac conduction, contractility (no negative inotropic effect) or ventricular repolarisation: - in clinical electrophysiology studies, ivabradine had no effect on atrioventricular or intraventricular conduction times or corrected QT intervals; - in patients with left ventricular dysfunction (left ventricular ejection fraction (LVEF) between 30
- u kliničkim ispitivanjima elektrofiziologije, ivabradin nije imao učinka na atrioventrikulska ili na intraventrikulska vremena provođenja ili korigirane QT-intervale; - u bolesnika s disfunkcijom lijeve klijetke (istisna frakcija lijeve klijetke (LVEF) između 30 i 45%),
In patients treated with ivabradine the risk of developing atrial fibrillation is increased (see section 4.8).
Povećan je rizik nastanka fibrilacije atrija u bolesnika koji se liječe ivabradinom (vidjeti dio 4.8).
If during treatment, heart rate decreases persistently below 50 beats per minute (bpm) at rest or the patient experiences symptoms related to bradycardia, the dose must be titrated downward to the next lower dose in patients receiving 7.5 mg twice daily or 5 mg twice daily.
Ukoliko se, tijekom liječenja, nastavi usporavati srčana frekvencija ispod 50 otkucaja u minuti (50/min) u mirovanju, ili u bolesnika nastupe simptomi koji su povezani s bradikardijom, doza se mora titrirati na slijedeću nižu u bolesnika koji primaju 7,5 mg dva puta dnevno ili 5 mg dva puta dnevno.
Use in patients with congenital QT syndrome or treated with QT prolonging medicinal products The use of ivabradine in patients with congenital QT syndrome or treated with QT prolonging medicinal products should be avoided (see section 4.5).
Treba izbjegavati primjenu ivabradina u bolesnika s QT-sindromom ili onih koji se liječe s pripravcima koji produljuju QT-interval (vidjeti dio 4.5).
In the subgroup of patients with HR ≥ 75 bpm and on the recommended target dose of beta-blocker, no statistically significant benefit was observed on the primary composite endpoint (hazard ratio: 0.97, 95%CI [0.74;1.28]) and other secondary endpoints, including hospitalisation for worsening heart failure (hazard ratio: 0.79, 95% CI [0.56;1.10]) or death from heart failure (hazard ratio: 0.69, 95% CI [0.31;1.53]).
U podskupini bolesnika sa srčanom frekvencijom ≥ 75/min koji primaju preporučenu ciljnu dozu beta-blokatora nije zabilježena značajna korist za primarni kompozitni ishod (omjer ugroženosti (HR): 0,97, 95%CI [0,74;1,28]) niti za ostale sekundarne ishode uključujući hospitalizaciju zbog pogoršanja zatajenja srca (omjer ugroženosti
Glycerol (E 422) Magnesium stearate (E 470 B) Yellow iron oxide (E172) Red iron oxide (E172)
Film ovojnica hipromeloza (E 464) titanijev dioksid (E171) makrogol 6000 glicerol (E 422) magnezijev stearat (E 470 B) željezov oksid, žuti (E172) željezov oksid, crveni (E172)
The possible occurrence of such luminous phenomena should be taken into account when driving or using machines in situations where sudden variations in light intensity may occur, especially when driving at night.
Kada bolesnik upravlja vozilom ili radi na stroju, u situacijama u kojima može iznenada doći do promjene u intenzitetu svjetla, osobito tijekom noćne vožnje, treba voditi računa o mogućnosti nastupanja vidnih poremećaja.
See package leaflet for the other excipients.
Vidjeti Uputu o lijeku za ostale pomoćne tvari.
NAME OF THE MEDICINAL PRODUCT Corlentor 5 mg film-coated tablets
NAZIV LIJEKA Corlentor 5 mg filmom obložene tablete
This increase in heart rate can cause the chest pain in people who suffer from angina.
U ljudi koji boluju od angine, to povećanje srčane frekvencije može uzrokovati bol u prsima.
NAME OF THE MEDICINAL PRODUCT Corlentor 7.5 mg film-coated tablets
NAZIV LIJEKA Corlentor 7,5 mg filmom obložene tablete
If, during treatment, heart rate decreases below 50 beats per minute (bpm) at rest or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward including the lowest dose of 2.5 mg twice daily (one half 5 mg tablet twice daily).
Ukoliko tijekom liječenja srčana frekvencija padne ispod 50 otkucaja u minuti (50/min) u mirovanju ili u bolesnika nastupe simptomi koji su povezani s bradikardijom, kao što su omaglica, umor ili hipotenzija, doza se mora titrirati na nižu, uključujući najnižu dozu od 2,5 mg dva puta na dan (polovica tablete od 5
Respiratory,
Omaglica,
Excipient with known effect: 63.91 mg lactose monohydrate For the full list of excipients, see section 6.1.
Pomoćna tvar s poznatim učinkom: 63,91 mg laktoze hidrata
possibly related to bradycardia
moguće povezano s bradikardijom
Corlentor 5 mg: one film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).
Corlentor 5 mg: jedna filmom obložena tableta sadrži 5 mg ivabradina (što odgovara 5,390 mg ivabradinklorida).
Syncope, possibly related to bradycardia
Sinkopa, moguće povezano s bradikardijom
6.4 Special precautions for storage
6.6 Posebne mjere za zbrinjavanje
Precautions for use
Mjere opreza pri primjeni
- if your resting heart rate before treatment is too slow (below 70 beats per minute); - if you are suffering from cardiogenic shock (a heart condition treated in hospital); - if you suffer from a heart rhythm disorder; - if you are having a heart attack; - if you suffer from very low blood pressure; - if you suffer from unstable angina (a severe form in which chest pain occurs very frequently and with or without exertion); - if you have heart failure which has recently become worse; - if your heart beat is exclusively imposed by your pacemaker; - if you suffer from severe liver problems; - if you are already taking medicines for the treatment of fungal infections (such as ketoconazole,
- ako Vam je srčana frekvencija u mirovanju prije liječenja prespora (manje od 70 otkucaja u minuti); - ako bolujete od kardiogenog šoka (medicinsko stanje koje se liječi u bolnici); - ako bolujete od poremećaja srčanog ritma; - ako imate srčani udar;
- The other ingredients in the tablet core are: lactose monohydrate, magnesium stearate (E 470 B), maize starch, maltodextrin, colloidal anhydrous silica (E 551), and in the tablet coating: hypromellose (E 464), titanium dioxide (E 171), macrogol 6000, glycerol (E 422), magnesium stearate (E 470 B), yellow iron oxide (E 172), red iron oxide (E 172).
- Pomoćne tvari u jezgri tablete su: laktoza hidrat, magnezijev stearat (E 470 B), kukuruzni škrob, maltodekstrin, bezvodni koloidni silicijev dioksid (E 551); a u ovojnici tablete: hipromeloza (E 464),
SIA Servier Latvia Tel: + 371 6750 2039
Tel: + 371 6750 2039
Laboratorios Servier, S.L.
Servier Laboratories (Ireland) Ltd.
Corlentor 7.5 mg: one film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).
Corlentor 7,5 mg: jedna filmom obložena tableta sadrži 7,5 mg ivabradina (što odgovara 8,085 mg ivabradinklorida).
de los Madroños, 33 -28043 Madrid, Spain The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Na tiskanoj uputi o lijeku mora se navesti naziv i adresa proizvođača odgovornog za puštanje navedene serije u promet.
However, in the absence of extensive data, non urgent DC-cardioversion should be considered 24 hours after the last dose of ivabradine.
kardioverzija se može učiniti 24 sata nakon posljednje doze ivabradina.
What Corlentor looks like and contents of the pack Corlentor 5 mg tablets are salmon-coloured, oblong film-coated tablets scored on both sides, engraved with “5” on one face and on the other.
Corlentor 5 mg tablete su duguljaste filmom obložene tablete boje lososa s razdjelnom crtom na obje strane, s utisnutom oznakom “5” na jednoj strani, a na drugoj.
Asthenia, possibly related to bradycardia Fatigue, possibly related to bradycardia
Astenija, moguće povezana s bradikardijom Umor, moguće povezan s bradikardijom
Make sure to tell your doctor if you are taking any of the following medicines, as a dose adjustment of Corlentor or monitoring should be required: - fluconazole (an antifungal medicine) - rifampicin (an antibiotic) - barbiturates (for difficult sleeping or epilepsy) - phenytoin (for epilepsy) - Hypericum perforatum or St John's Wort (herbal treatment for depression) - QT prolonging medicines to treat either heart rhythm disorders or other conditions : - quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders) - bepridil (to treat angina pectoris) - certain types of medicines to treat anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole) - anti-malarial medicines (such as mefloquine or halofantrine) - intravenous erythromycin (an antibiotic) - pentamidine (an antiparasitic medicine) - cisapride (against the gastro-oesophageal reflux) - Some types of diuretics which may cause decrease in blood potassium level, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure).
Ako uzimate neke od slijedećih lijekova, svakako o tome obavijestite svog liječnika koji bi trebao prilagoditi dozu Corlentora ili pratiti liječenje: - flukonazol (antifungik) - rifampicin (antibiotik) - barbiturati (za otežano spavanje ili epilepsiju) - fenitoin (za epilepsiju) - Hypericum perforatum ili Gospina trava (biljna terapija za depresiju) - lijekovi koji produljuju QT-interval i primjenjuju se za liječenje poremećaja srčanog ritma ili drugih bolesti:
PK/PD relationship analysis has shown that heart rate decreases almost linearly with increasing ivabradine and S 18982 plasma concentrations for doses of up to 15-20 mg twice daily.
Analiza PK/PD odnosa pokazala je da se srčana frekvencija gotovo linearno smanjuje, kako se povećavaju koncentracije ivabradina i metabolita
Salmon-coloured, oblong, film-coated tablet scored on both sides, engraved with “5” on one face and on the other face.
Duguljasta filmom obložena tableta boje lososa s razdjelnom crtom na obje strane, s utisnutom oznakom “5” na jednoj strani a na drugoj.
Therefore the intake of grapefruit juice should be avoided.
Stoga je tijekom liječenja ivabradinom potrebno izbjegavati konzumiranje soka od grejpa.
In the subgroup of patients with HR ≥ 75 bpm (n=4150), a greater reduction was observed in the primary composite endpoint of 24 % (hazard ratio: 0.76, 95%CI [0.68;0.85] - p<0.0001) and for other secondary endpoints, including all cause death (hazard ratio: 0.83, 95%CI [0.72;0.96] - p=0.0109) and CV death (hazard ratio: 0.83, 95%CI [0.71;0.97] - p=0.0166).
U podskupini bolesnika sa srčanom frekvencijom ≥ 75/min (n=4 150), zabilježeno je izraženije smanjenje primarnog kompozitnog ishoda od 24% (omjer ugroženosti (HR): 0,76, 95%CI [0,68;0,85] - p<0,0001)
It may harm them, even if their signs of illness are the same as yours.
Može im štetiti, čak i ako su njihovi znakovi bolesti jednaki Vašima.
josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone (see sections 4.5 and 5.2) - Combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties (see section 4.5) - Pregnancy, lactation and women of child-bearing potential not using appropriate contraceptive measures (see section 4.6)
Istodobna primjena s inhibitorima citokroma P450 3A4 kao što su azolni antimikotici (ketokonazol, itrakonazol), makrolidni antibiotici (klaritromicin, eritromicin per os, jozamicin, telitromicin), inhibitori proteaze HIV-a (nelfinavir, ritonavir) i nefazodon (vidjeti dijelove 4.5 i 5.2) Istodobna primjena s verapamilom ili diltiazemom koji su umjereni inhibitori CYP3A4 s učinkom na smanjenje srčane frekvencije (vidjeti dio 4.5)
Erythema Pruritus Urticaria
Tablični prikaz nuspojava
Caution should be exercised when using ivabradine in patients with moderate hepatic impairment.
Pri primjeni ivabradina u bolesnika s umjerenim oštećenjem jetre potreban je oprez.
NAME OF THE MEDICINAL PRODUCT Corlentor 5 mg film-coated tablets ivabradine
Corlentor 5 mg filmom obložene tablete ivabradin
Visual function
NAVOĐENJE DJELATNE/IH
Dizziness, possibly related to bradycardia
Malaksalost, moguće povezano s bradikardijom
Patients with hypotension
Mjere opreza pri primjeni Bolesnici s hipotenzijom
NAME OF THE MEDICINAL PRODUCT Corlentor 7.5 mg film-coated tablets ivabradine
Corlentor 7,5 mg filmom obložene tablete ivabradin
- Non cardiovascular QT prolonging medicinal products (e.g. pimozide, ziprasidone, sertindole,
- lijekovi za liječenje anksioznosti, shizofrenije ili drugih psihoza (kao što su pimozid, ziprasidon,
There is no evidence of risk of (excessive) bradycardia on return to sinus rhythm when pharmacological cardioversion is initiated in patients treated with ivabradine.
Pri farmakološkoj konverziji u sinusni ritam, u bolesnika koji se liječe ivabradinom, nije zabilježena opasnost od razvoja (prekomjerne) bradikardije.
One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).
Jedna filmom obložena tableta sadrži 7,5mg ivabradina (što odgovara 8,085 mg ivabradinklorida)
Concomitant use with precautions - Moderate CYP3A4 inhibitors: the concomitant use of ivabradine with other moderate CYP3A4 inhibitors (e.g. fluconazole) may be considered at the starting dose of 2.5 mg twice daily and if resting heart rate is above 70 bpm, with monitoring of heart rate.
inhibitorima (npr. flukonazol) je moguća uz početnu dozu od 2,5 mg dva puta na dan, te ako je srčana frekvencija u mirovanju veća od 70/min te uz praćenje frekvencije srca.
0.5% of patients experienced a severe bradycardia below or equal to 40 bpm.
bolesnika imalo je tešku bradikardiju s brojem otkucaja u minuti ispod ili jednako 40.
Therefore, ivabradine is contra-indicated during breast-feeding (see section 4.3).
Stoga je ivabradin kontraindiciran u žena koje doje (vidjeti dio 4.3).
No dose adjustment is required in patients with mild hepatic impairment.
U bolesnika s blagim oštećenjem jetrene funkcije nije potrebno prilagođavati dozu.
Salmon-coloured, triangular, film-coated tablet engraved with “7.5” on one face and on the other face.
Trokutasta filmom obložena tableta boje lososa s utisnutom oznakom “7,5” na jednoj strani, a na drugoj.
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Resting heart rate below 70 beats per minute prior to treatment - Cardiogenic shock - Acute myocardial infarction - Severe hypotension (< 90/50 mmHg) - Severe hepatic insufficiency - Sick sinus syndrome - Sino-atrial block - Unstable or acute heart failure - Pacemaker dependent (heart rate imposed exclusively by the pacemaker) - Unstable angina - AV-block of 3rd degree - Combination with strong cytochrome P450 3A4 inhibitors such as azole antifungals
Akutni infarkt miokarda Teška hipotenzija (< 90/50 mmHg) Teška insuficijencija jetre Sindrom bolesnog sinusnog čvora Sinusatrijski blok Nestabilno ili akutno zatajenje srca
It participates in the temporal resolution of the visual system, by curtailing the retinal response to bright light stimuli.
Također postoji mogućnost interakcije ivabradina sa Ih strujom retine koja je vrlo slična srčanoj If. Ona sudjeluje u temporalnoj rezoluciji vidnog sustava, smanjujući odgovor retine na jake svjetlosne podražaje.
STATEMENT OF ACTIVE SUBSTANCE(S) One film-coated tablet contains 5 mg ivabradine (equivalent to 5.39 mg ivabradine as hydrochloride)
TVARI Jedna filmom obložena tableta sadrži 5mg ivabradina (što odgovara 5,39 mg ivabradinklorida)
Corlentor 5 mg film-coated tablets Corlentor 7.5 mg film-coated tablets ivabradine
Uputa o lijeku: Informacija za bolesnika Corlentor 5 mg filmom obložene tablete Corlentor 7,5 mg filmom obložene tablete ivabradin
The intake of St John's Wort should be restricted during the treatment with ivabradine.
Tijekom liječenja s ivabradinom potrebno je ograničiti uzimanje Gospine trave.
5 How to store Corlentor Contents of the pack and other information
Kako Corlentor izgleda i sadržaj pakovanja
As the treatment for angina or chronic heart failure is usually life-long, you should discuss with your doctor before stopping this medicinal product.
Ako prestanete uzimati Corlentor: Liječenje angine ili kroničnog zatajenja srca obično je doživotno.
Lactose monohydrate Magnesium stearate (E 470 B) Maize starch
Jezgra laktoza hidrat magnezijev stearat (E 470 B) kukuruzni škrob maltodekstrin silicijev dioksid, koloidni, bezvodni (E 551)
One film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 5mg ivabradina (što odgovara 5,390 mg ivabradinklorida).
Magyarország Servier Hungaria Kft. Tel.: + 36 1 238 77 99
Tel.: + 36 1 238 77 99
Film-coating
Konstipacija Proljev
Rash
ČET
Servier Laboratories (Ireland) Ltd. Tel: +353 (0)1 6638110
Servier Pharma d.o.o. Tel: + 386 (0)1 563 48 11
Other concomitant use
Istobna primjena drugih lijekova
ventricular or supraventricular tachycardia).
umjereni i jaki inhibitori).
Data are insufficient to draw conclusions in patients with moderate hepatic impairment.
U bolesnika s umjerenim oštećenjem jetre nema dovoljno podataka.
Servier Pharma d.o.o.
Servier Nederland Farma B.V.
STATEMENT OF ACTIVE SUBSTANCE(S)
Ελλάδα ΣΕΡΒΙΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ
It is used to treat:
Ovaj se lijek koristi za liječenje:
This summary was last updated in 04-2015.
Sažetak je posljednji put ažuriran : 04. 2015.
The dose depends on the disease being treated, the age and condition of the patient, and the response to treatment, but it should not exceed 800 mg a day.
Doza ovisi o bolesti koja se liječi, dobi i stanju bolesnika, te reakciji na liječenje, no ne smije premašiti 800 mg na dan.
The full EPAR for the reference medicine can also be found on the Agency's website.
Cjeloviti EPAR za referentni lijek također je dostupan na internetskim stranicama Agencije.
The full EPAR for Imatinib medac can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR dostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Dva su lijeka su bioekvivalentna kada u tijelu proizvode iste razine djelatne tvari.
This means that it blocks some specific enzymes known as tyrosine kinases.
To znači da blokira određene enzime poznate pod nazivom tirozin kinaze.
Imatinib medac is available as capsules (100 and 400 mg).
Lijek Imatinib medac dostupan je u kapsulama (100 i 400 mg).
• Adults with Ph+ CML in blast crisis;
• odraslih osoba s Ph+ KML-om u blastičnoj krizi;
These enzymes can be found in certain receptors in cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably.
Ti se enzimi nalaze u određenim receptorima u stanicama raka, uključujući i receptore koji su uključeni u stimulaciju stanica za nekontrolirano dijeljenje.
This means that Imatinib medac is similar to a ‘reference medicine' already authorised in the European Union (EU) called Glivec.
To znači da je lijek Imatinib medac sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Glivec.
It can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of patients with cancers of the blood or solid tumours.
Ovaj se lijek izdaje samo na liječnički recept, a terapiju mora započeti liječnik s iskustvom u liječenju bolesnika s različitim rakovima krvi ili solidnim tumorima.
This means that some of their genes have re-arranged themselves to form a special chromosome called the Philadelphia chromosome.
To znači da su se njihovi određeni geni preraspodijelili tako da tvore poseban kromosom nazvan Philadelphia kromosom.
Therefore, the CHMP's view was that, as for Glivec, the benefit outweighs the identified risk.
Stoga je stav CHMP-a da, kao i kod lijeka Glivec, koristi nadmašuju identificirane rizike.
The European Commission granted a marketing authorisation valid throughout the European Union for Imatinib medac on 25 September 2013.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Imatinib medac na snazi u Europskoj uniji od 25. rujna 2013.
It is also used in children in the ‘chronic phase' of the disease if it is not responding to interferon alpha (another anticancer medicine), and in more advanced phases of the disease (‘accelerated phase' and ‘blast crisis').
Lijek se također koristi u djece u „kroničnoj fazi” bolesti nakon neuspjeha terapije interferonom-alfa (drugog antikancerogenog lijeka), te u uznapredovanim fazama bolesti („u ubrzanoj fazi” ili „u blastičnoj krizi”);
This is a summary of the European public assessment report (EPAR) for Imatinib medac.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Imatinib medac.
Imatinib medac is given by mouth with a meal and a large glass of water to reduce the risk of irritation of the stomach and gut.
Imatinib medac se uzima peroralno uz obrok i veliku čašu vode kako bi se smanjio rizik od iritacije želuca i crijeva.
What measures are being taken to ensure the safe and effective use of Imatinib medac?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Imatinib medac?
What are the benefits and risks of Imatinib medac?
Koje su koristi i rizici od lijeka Imatinib medac?
It is not intended to provide practical advice on how to use Imatinib medac.
Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Imatinib medac.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Imatinib medac has been shown to have comparable quality and to be bioequivalent to Glivec.
Odbor za lijekove za humanu primjenu (CHMP) pri Agenciji zaključilo je kako je u skladu sa zahtjevima EU-a, potvrđeno kako lijek Imatinib medac posjeduje usporedivu kvalitetu te je bioekvivalentan lijeku Glivec.
A risk management plan has been developed to ensure that Imatinib medac is used as safely as possible.
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Imatinib medac.
By blocking these receptors, Imatinib medac helps to control cell division.
Blokirajući te receptore, lijek Imatinib medac pomaže u kontroli podjele stanica.
• Adults with myelodysplastic or myeloproliferative diseases (MDS/MPD), a group of diseases in which the body produces large numbers of abnormal blood cells.
• odraslih osoba s mijelodisplastičnim ili mijeloproliferativnim bolestima (MDS/MPD), grupom bolesti u kojima tijelo proizvodi veliki broj abnormalnih krvnih stanica.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Imatinib medac, 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 Imatinib medac nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati.