natgillin/translations-raw huggingface dataset:
YENTREVE 20 mg Opaque blue body, imprinted with ‘20 mg' and an opaque blue cap, imprinted with ‘9544'.
Neprozirno tijelo plave boje s otisnutom oznakom „20 mg“ i neprozirna plava kapica s otisnutom oznakom „9544“.
YENTREVE 40 mg hard gastro-resistant capsules Duloxetine
YENTREVE 40 mg tvrde želučanootporne kapsule duloksetin
Orthostatic hypotension2 Peripheral coldness
hipertenzivna kriza3 ortostatska hipotenzija2
Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Red iron oxide (E172) Yellow iron oxide (E172) Edible black ink
YENTREVE 40 mg želatina natrijev laurilsulfat titanijev dioksid (E171) indigo karmin (E132) željezov oksid, crveni (E172) željezov oksid, žuti (E172) crna tinta, jestiva
The antibiotic linezolid is a reversible non-selective MAOI and should not be given to patients treated with YENTREVE (see section 4.4).
inhibitor i ne smije se davati bolesnicima koji se liječe lijekom YENTREVE (vidjeti dio 4.4).
YENTREVE and Prior Continence Surgery: There are limited data that suggest that the benefits of YENTREVE are not diminished in women with stress urinary incontinence who have previously undergone continence surgery.
YENTREVE nisu umanjene u žena sa stresnom urinarnom inkontinencijom koje su prethodno bile podvrgnute kirurškom liječenju inkontinencije.
Stevens-Johnson Syndrome6
Stevens-Johnsonov sindrom6 angioneurotski edem6 reakcije fotoosjetljivosti kutani vaskulitis
Furthermore, increases in INR values have been reported when duloxetine was co-administered to patients treated with warfarin.
INR-a kada se duloksetin primjenjivao istodobno u bolesnica liječenih varfarinom.
Duloxetine has a large volume of distribution and forced diuresis, haemoperfusion, and exchange perfusion are unlikely to be beneficial.
hemoperfuzija i izmjena perfuzijom (peritonealna dijaliza) vjerojatno ne bi bile korisne.
Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Edible black ink
YENTREVE 20 mg želatina natrijev laurilsulfat titanijev dioksid (E171) indigo karmin (E132) crna tinta, jestiva
Each capsule contains 20 or 40 mg of duloxetine (as hydrochloride).
Jedna kapsula sadrži 20 ili 40 mg duloksetina (u obliku duloksetinklorida).
YENTREVE contains the active substance duloxetine.
Što je YENTREVE i za što se koristi YENTREVE sadrži djelatnu tvar duloksetin.
• diarrhoea, stomach pain, being sick (vomiting), heartburn or indigestion
• proljev, bol u želucu, povraćanje, žgaravica ili probavne tegobe
Urine flow decreased
poliurija smanjen protok mokraće
Hyperglycaemia (reported especially in diabetic patients) Hyponatraemia
Poremećaji metabolizma i prehrane smanjen apetit dehidracija hiperglikemija (prijavljena posebno u bolesnica sa šećernom bolešću)
YENTREVE 40 mg Opaque orange body, imprinted with '40 mg' and an opaque blue cap, imprinted with ‘9545'.
Neprozirno tijelo narančaste boje s otisnutom oznakom „40 mg“ i neprozirna plava kapica s otisnutom oznakom „9545“.
QUALITATIVE AND QUANTITATIVE COMPOSITION
KVALITATIVNI I KVANTITATIVNI SASTAV YENTREVE 20 mg
YENTREVE 20 mg hard gastro-resistant capsules YENTREVE 40 mg hard gastro-resistant capsules
YENTREVE 20 mg tvrde želučanootporne kapsule YENTREVE 40 mg tvrde želučanootporne kapsule
8 Falls were more common in the elderly (≥65 years old).
Padovi su bili češći u starijih osoba (≥ 65 godina starosti) 9 Učestalost procijenjena na temelju svih podataka iz kliničkih ispitivanja.
There have been reports of bleeding abnormalities, such as ecchymoses, purpura and gastrointestinal haemorrhage with selective serotonin reuptake inhibitors (SSRIs) and serotonin/noradrenaline reuptake inhibitors (SNRIs), including duloxetine.
Kod primjene selektivnih inhibitora ponovne pohrane serotonina (SSRI) i inhibitora ponovne pohrane serotonina i noradrenalina (SNRI), uključujući duloksetin, bilo je izvješća o abnormalnim krvarenjima,
YENTREVE is for oral use.
YENTREVE se uzima kroz usta.
Asthenia Chills
KLINIČKI PODACI
Eli Lilly Norge A.S Tlf: +47 22 88 18 00
Tlf: +47 22 88 18 00
EU/1/04/280/006
12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/280/006
- are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6) - have liver disease - have severe kidney disease - are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see ‘Other medicines and YENTREVE') - are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections
− ako uzimate ili ste unutar zadnjih 14 dana uzimali drugi lijek koji je poznat kao inhibitor monoaminooksidaze (MAOI) (pogledajte „Drugi lijekovi i YENTREVE“)
The co-administration of duloxetine (40 mg twice daily) increases steady state AUC of tolterodine (2 mg twice daily) by 71 %, but does not affect the pharmacokinetics of its active 5-hydroxyl metabolite and no dosage adjustment is recommended.
Istodobna primjena duloksetina (40 mg dvaput dnevno) povećava AUC tolterodina (2 mg dvaput dnevno) u stanju dinamičke ravnoteže za
Do not take more than the daily amount of YENTREVE that has been prescribed for you in one day.
Nemojte u jednome danu uzeti više od propisane dnevne doze lijeka YENTREVE.
Skin and subcutaneous tissue disorders Sweating increased
Poremećaji kože i potkožnog tkiva pojačano znojenje osip noćno znojenje urtikarija kontaktni dermatitis hladan znoj povećana sklonost stvaranju modrica
Diarrhoea Abdominal pain Vomiting Dyspepsia
Poremećaji imunološkog sustava poremećaj preosjetljivosti anafilaktička reakcija
Common side effects (may affect up to 1 in 10 people)
Česte nuspojave (mogu se javiti u najviše 1 na 10 osoba):
Each capsule contains 40 mg of duloxetine (as hydrochloride).
Jedna kapsula sadrži 40 mg duloksetina (u obliku duloksetinklorida).
How to store YENTREVE Keep this medicine out of the sight and reach of children.
Lijek čuvajte izvan pogleda i dohvata djece.
Each capsule contains 20 mg of duloxetine (as hydrochloride).
Jedna kapsula sadrži 20 mg duloksetina (u obliku duloksetinklorida).
Some fatalities have occurred, primarily with mixed overdoses, but also with duloxetine alone at a dose of approximately 1000 mg. Signs and symptoms of overdose (duloxetine alone or in combination with other medicinal products) included somnolence, coma, serotonin syndrome, seizures, vomiting and tachycardia.
Znakovi i simptomi predoziranja (samim duloksetinom ili u kombinaciji s drugim lijekovima) uključivali su somnolenciju,
Eructation Gastritis Dysphagia Flatulence Breath odour
Poremećaji probavnog sustava mučnina suha usta konstipacija proljev bol u abdomenu povraćanje dispepsija gastrointestinalno krvarenje7 gastroenteritis stomatitis podrigivanje gastritis disfagija flatulencija zadah iz usta
Hypertension3,7 Flushing
Krvožilni poremećaji hipertenzija3,7 crvenilo uz osjećaj vrućine sinkopa2 povišeni krvni tlak3
• dizziness, tingling feelings like pins and needles or electric shock-like feelings (particularly in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, sleepiness, feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), shaking (tremor), headaches, muscle pain, feeling irritable, diarrhoea, excessive sweating or vertigo.
poremećaji spavanja (živopisni snovi, noćne more, nemogućnost spavanja), umor, pospanost, osjećaj nemira ili uznemirenosti, osjećaj tjeskobe, mučnina ili povraćanje, nevoljno drhtanje
Blurred vision Mydriasis Visual impairment
Poremećaji oka zamućen vid midrijaza poremećaj vida suho oko glaukom
Clinical efficacy and safety
UČINKOVITU PRIMJENU LIJEKA
• muscle twitching
• trzanje mišića
• feeling sick (nausea), dry mouth, constipation • fatigue
• mučnina, suha usta, zatvor
• throat tightness, nose bleeds
• stezanje u grlu, krvarenja iz nosa
YENTREVE 20 mg hard gastro-resistant capsules.
(20 mg tvrde želučanootporne kapsule)
Tremor
OBLIK
YENTREVE 40 mg hard gastro-resistant capsules.
KUTIJE ZA 40 MG TVRDE ŽELUČANOOTPORNE KAPSULE
Sugar spheres
Gospina trava
Duloxetine is very weakly excreted into human milk based on a study of 6 lactating patients, who did not breast feed their children.
Na temelju ispitivanja provedenom na 6 bolesnica u laktaciji koje nisu dojile svoju djecu pokazalo se da se duloksetin u majčino mlijeko izlučuje u vrlo maloj mjeri.
YENTREVE 40 mg hard gastro-resistant capsules YENTREVE 20 mg hard gastro-resistant capsules
YENTREVE 40 mg tvrde želučanootporne kapsule YENTREVE 20 mg tvrde želučanootporne kapsule duloksetin (u obliku duloksetinklorida)
Eli Lilly Ges.m.b.H.
Eli Lilly Norge A.S
Feeling hot
periferna hladnoća
If you get any side effects, talk to your doctor of pharmacist.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
Dyskinesia Restless legs syndrome
Antibiotik linezolid je reverzibilan neselektivan MAO
Gynaecological haemorrhage Menopausal symptoms
Poremećaji reproduktivnog sustava i dojki ginekološko krvarenje simptomi menopauze menstrualni poremećaj galaktoreja hiperprolaktinemija poslijeporođajno krvarenje6
Haemorrhage
• umor
Respiratory, thoracic and mediastinal disorders Yawning
poput ekhimoza, purpure i gastrointestinalnih krvarenja.
Very rare
Vrlo rijetko:
EMA/PRAC/590265/2015
EMA/PRAC/618057/2015 Corr1
What you need to know before you <take> <use> X:
Dio 2: Što morate znati prije nego počnete <uzimati> <primjenjivati> X
Adopted at the 7-10 September 2015 PRAC
Usvojeno na sjednici PRAC-a 7. - 10. rujna 2015.
• Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
• Obratite se liječniku ako imate bol u uhu, iscjedak iz uha i/ili infekciju uha.
Section 4.4
Dio 4.4:
Possible side effects Tell your doctor immediately if you experience:
Dio 4.: Moguće nuspojave Odmah obavijestite svog liječniku u slučaju:
Frequency ‘not known': pulmonary hypertension
Učestalost „nepoznato": plućna hipertenzija
Bisphosphonates (alendronic acid; alendronic acid, colecalciferol; clodronic acid; etidronic acid; ibandronic; neridronic acid; pamidronic acid; risedronic acid; tiludronic acid; zoledronic acid) - Osteonecrosis of the external auditory canal (EPITT no 18256)
Bisfosfonati (alendronatna kiselina; alendronatna kiselina, kolekalciferol; klodronatna kiselina; etidronatna kiselina; ibandronatna kiselina; neridronatna kiselina; pamidronatna kiselina; risedronatna kiselina; tiludronatna kiselina; zoledronatna kiselina) - osteonekroza vanjskog slušnog kanala (EPITT br. 18256)
HLA-DRB1*04:03 allele (susceptibility to IAS odds ratio: 1.6) is especially found in Caucasians, with a higher prevalence in southern than in northern Europe and HLA-DRB1*04:06 allele (susceptibility to IAS odds ratio: 56.6) is especially found in Japanese and Korean patients.
HLA-DRB1*04:03 alel (omjer izgleda podložnosti prema IAS: 1,6) posebno je prisutan u bijelaca, s većom prevalencijom na jugu u odnosu na sjever Europe i HLA-DRB1*04:06 alel (omjer izgleda podložnosti prema IAS: 56,6) posebno je prisutan u japanskih i korejskih bolesnika.
Leflunomide - Pulmonary hypertension (EPITT no 18221)
Leflunomid1 - plućna hipertenzija (EPITT br. 18221)
- a cough or breathing problems as these may indicate inflammation problems of the lung (interstitial lung disease or pulmonary hypertension);
- kašlja ili problema s disanjem, jer to može upućivati na upalu probleme s plućima (intersticijska plućna bolest ili plućna hipertenzija),
Frequency ‘uncommon': Cases of suspected capillary leak syndrome have been reported with trabectedin.
Učestalost „manje često": Slučajevi sumnje na sindrom kapilarnog curenja prijavljeni su s trabektedinom.
IAS should be considered in the differential diagnosis of spontaneous hypoglycaemia in patients using thioctic acid (see section 4.8).
IAS je potrebno uzeti u obzir u diferencijalnoj dijagnozi spontane hipoglikemije u bolesnika koji koriste tioktatnu kiselinu (vidjeti dio 4.8.).
Patients with a certain human leukocyte antigen genotype (which is more frequent in Japanese and Korean patients, but is also found in Caucasians) are more prone to development of insulin autoimmune syndrome (disorder of the blood glucose regulating hormones with pronounced lowering of blood sugar levels) when treated with thioctic acid.
Bolesnisi s određenim genotipom humanog leukocitnog antigena (koji je češće prisutan u japanskih i korejskih bolesnika, no prisutan je i u bijelaca) podložniji su razvitku autoimunog inzulinskog sindroma (poremećaj hormona koji reguliraju glukozu u krvi sa značajnim sniženjem koncentracije šećera u krvi) kada se liječe tioktatnom kiselinom.
Cases of Insulin Autoimmune Syndrome (IAS) have been reported during treatment with thioctic acid.
Insulin Autoimmune Syndrome, IAS) prijavljeni su tijekom liječenja tioktatnom kiselinom.
The risk of its their occurrence is can be increased in patients with a history of interstitial lung disease.
Rizik od njezine njihove pojave može biti povećan je u bolesnika s intersticijskom plućnom bolesti u anamnezi.
Patients with human leukocyte antigen genotype such as HLA-DRB1*04:06 and HLA-DRB1*04:03 alleles, are more susceptible to develop IAS when treated with thioctic acid.
Bolesnici s genotipom humanog leukocitnog antigena poput HLA-DRB1*04:06 i HLA-DRB1*04:03 alela, podložniji su razvitku IAS-a kada se liječe tioktatnom kiselinom.
Section 4.8 Very rare: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction).
Vrlo rijetko: Osteonekroza vanjskog slušnog kanala (nuspojava razreda bisfosfonata).
Frequency unknown: Disorder of the blood glucose regulating hormones with pronounced lowering of blood sugar levels (insulin autoimmune syndrome).
Nepoznata učestalost: Poremećaj hormona koji reguliraju glukozu u krvi sa značajnim sniženjem koncentracije šećera u krvi (autoimuni inzulinski sindrom).
Interstitial lung disease, as well as rare cases of pulmonary hypertension has have been reported during treatment with leflunomide (see section 4.8).
Za vrijeme liječenja leflunomidom zabilježena je intersticijska plućna bolest, kao i rijetki slučajevi plućne hipertenzije (vidjeti dio 4.8.).
Frequency unknown: insulin autoimmune syndrome (see section 4.4)
Učestalost nije poznata: autoimuni inzulinski sindrom (vidjeti dio 4.4.).
Other side effects such as kidney failure, a decrease in the levels of uric acid in your blood, pulmonary hypertension, male infertility [...] may also occur with an unknown frequency.
Također se mogu javiti druge nuspojave, poput zatajenja bubrega, smanjene koncentracije mokraćne kiseline u krvi, plućne hipertenzije, muške neplodnosti [...], ali je njihova učestalost nepoznata.
Trabectedin - Capillary leak syndrome (EPITT no 18115)
Trabektedin - Sindrom kapilarnog curenja (EPITT br.
Section 4.8 - Undesirable effects: Respiratory, thoracic and mediastinal disorders
Dio 4.4 - Posebna upozorenja i mjere opreza pri uporabi
Thioctic acid - Insulin autoimmune syndrome (EPITT no
Tioktatna kiselina - autoimuni inzulinski sindrom (EPITT br. 18406)
The way it works in this disease is not completely understood.
Način djelovanja kod ove bolesti nije u potpunosti poznat.
As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 10 August 2010.
Budući da je tvrtka dostavila dodatne zatražene informacije, „iznimne okolnosti” prestale su vrijediti 10. kolovoza
This summary was last updated in 11-2016.
Sažetak je posljednji put ažuriran: 11.2016.
The infusion should last one to two hours, but it may last longer if the patient has certain side effects.
Infuzija treba trajati jedan do dva sata, ali može trajati dulje ako bolesnik ima određene nuspojave.
If this does not happen by day 50 (for previously treated patients) or by day 60 (for newly diagnosed patients), the treatment should be stopped.
Ako se to ne dogodi do 50. dana (u prethodno liječenih bolesnika) ili do 60. dana (u novodijagnosticiranih bolesnika), liječenje se treba prekinuti.
The full EPAR for Trisenox can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za lijek Trisenox nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Forty-five of the patients in the studies were adults.
Četrdeset i pet bolesnika u ispitivanjima bili su odrasle osobe.
The main measure of effectiveness was the number of patients who had complete remission.
Glavna mjera djelotvornosti bio je broj bolesnika s potpunom remisijom.
On average, it took 57 days for the patients to reach complete remission.
Bolesnicima je u prosjeku trebalo 57 dana za postizanje potpune remisije.
The treatment is divided into 2 phases: induction and consolidation.
Liječenje je podijeljeno u dvije faze: fazu indukcije i fazu konsolidacije.
Trisenox was originally authorised under ‘exceptional circumstances', because, as the disease is rare, limited information was available at the time of approval.
Lijek Trisenox prvobitno je odobren u „iznimnim okolnostima” zbog toga što su, uzevši u obzir da je bolest rijetka, u trenutku izdavanja odobrenja bile dostupne samo ograničene informacije.
The number of times these cycles are repeated depends on whether patients have received previous treatment or not.
Broj ponavljanja ciklusa ovisi o tome jesu li bolesnici prethodno liječeni.
The European Commission granted a marketing authorisation valid throughout the European Union for Trisenox on 5 March 2002.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Trisenox na snazi u Europskoj uniji od 5. ožujka 2002.
The most common side effects with Trisenox (seen in 1 patient in 10) are hyperglycaemia (high blood glucose levels), hypomagnesaemia (low blood magnesium levels), hypokalaemia (low blood potassium levels), paraesthesia (unusual sensations like pins and needles), dizziness, headache, tachycardia (rapid heartbeat), dyspnoea (difficulty breathing), differentiation syndrome (a potentially fatal complication of chemotherapy in patients with APL), diarrhoea, vomiting, nausea (feeling sick), pruritus (itching), rash, myalgia (muscle pain), pyrexia (fever), pain, fatigue (tiredness), oedema (swelling), prolonged QT interval on an electrocardiogram (an alteration of the electrical activity of the heart), and increased levels of alanine aminotransferase and aspartate aminotransferase (liver enzymes).
Najčešće nuspojave lijeka Trisenox (uočene u 1 na 10 bolesnika) jesu hiperglikemija (povišena razina glukoze u krvi), hipomagnezijemija (niske razine magnezija u krvi), hipokalemija (niske razine kalija u krvi), parestezija (neuobičajeni osjeti poput bockanja iglama), omaglica, glavobolja, tahikardija (ubrzani otkucaji srca), dispneja (poteškoće u disanju), sindrom diferencijacije (potencijalno smrtonosna komplikacija kemoterapije u bolesnika s APL-om), proljev, povraćanje, mučnina, pruritus (svrbež), osip, mialgija (bol u mišićima), pireksija (vrućica), bol, umor (malaksalost), edem (oticanje), produljeni QT interval na elektrokardiogramu (promjena električne aktivnosti srca) i povišene razine alanin aminotransferaze i aspartat aminotransferaze (jetreni enzimi).
This is a summary of the European public assessment report (EPAR) for Trisenox.
Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za lijek Trisenox.
Looking at the results of these two studies together, 87% of the patients had complete remission (45 out of 52).
Uzevši u obzir rezultate obaju ispitivanja zajedno, u 87 % bolesnika (45 od 52) zabilježena je potpuna remisija.
During the consolidation phase, Trisenox is given once a day for five days, followed by a two-day break, repeated for four or five weeks.
Tijekom faze konsolidacije lijek Trisenox daje se jedanput dnevno tijekom pet dana nakon čega slijedi pauza od dva dana, a cijeli se postupak ponavlja četiri ili pet tjedana.
• Patients with APL whose disease has not responded to previous treatment with a retinoid and cancer medicines, or when their disease has come back after this type of treatment.
• u bolesnika s APL-om čija bolest nije reagirala na prethodno liječenje retinoidnim lijekovima i lijekovima za liječenje raka ili čija se bolest ponovno javila nakon takvog liječenja.
97% (72 out of 74) of patients treated with Trisenox did not have any event, compared with 86% (65 out of 76) of those treated with anthracyclines.
U 97 % bolesnika (72 od 74) liječenih lijekom Trisenox nije zabilježen nikakav događaj, u usporedbi s 86 % bolesnika (65 od 76) liječenih antraciklinima.
It is thought to prevent the production of DNA, which is necessary for leukaemia cells to grow.
Smatra se da sprečava stvaranje DNK koja je neophodna za rast stanica leukemije.
The recommended dose of Trisenox depends on the body weight of the patient.
Preporučena doza lijeka Trisenox ovisi o tjelesnoj težini bolesnika.
What measures are being taken to ensure the safe and effective use of Trisenox?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Trisenox?
The translocation affects the way the white blood cells grow, and as a result they lack the ability to use retinoic acid (vitamin A).
Translokacija utječe na rast bijelih krvnih stanica, koje kao rezultat toga nisu sposobne upotrebljavati retinoatnu kiselinu (vitamin A).
During the induction phase, Trisenox is given every day until there are signs that the treatment is working (when the bone marrow does not contain any leukaemia cells).
Tijekom faze indukcije lijek Trisenox daje se svakog dana do pojave znakova da liječenje djeluje (kada u koštanoj srži nema stanica leukemije).
It is not intended to provide practical advice on how to use Trisenox.
Svrha sažetka nije davati praktične savjete o primjeni lijeka Trisenox.
Why is Trisenox approved?
Zašto je Trisenox odobren?
This is when there are no more leukaemia cells in the bone marrow and the levels of platelets and white blood cells in the blood have recovered.
To je stanje kada u koštanoj srži više nema stanica leukemije, a razine trombocita i bijelih krvnih stanica vraćene su na uobičajene razine.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trisenox 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 Trisenox nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
What is Trisenox and what is it used for?
Što je Trisenox i za što se koristi?
Other information about Trisenox
Ostale informacije o lijeku Trisenox
The CHMP decided that Trisenox's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za lijekove za primjenu kod ljudi odlučio je da koristi lijeka Trisenox nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
Trisenox is used to treat adults (aged 18 years or over) with acute promyelocytic leukaemia (APL), a rare form of leukaemia (cancer of the white blood cells) caused by a genetic ‘translocation' (when there is a swap of genes between two chromosomes).
Lijek Trisenox primjenjuje se u liječenju odraslih osoba (u dobi od 18 godina ili više) s akutnom promijelocitnom leukemijom (APL), rijetkim oblikom leukemije (rak bijelih krvnih stanica) izazvanom translokacijom gena (zamjena gena između dvaju kromosoma).
Trisenox has also been investigated in two studies involving a total of 52 patients with APL who had been previously treated with an anthracycline and a retinoid.
Lijek Trisenox također je ispitivan u dvama ispitivanjima koja su obuhvatila ukupno 52 bolesnika s APL-om koji su prethodno liječeni antraciklinom i retinoidom.
Patients with APL are normally treated with retinoids (substances derived from vitamin A).
Bolesnici s APL-om uglavnom se liječe retinoidima (derivati vitamina A).
Trisenox can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the management of patients with acute leukaemias.
Lijek Trisenox izdaje se samo na recept, a liječenje mora nadzirati liječnik s iskustvom u liječenju bolesnika s akutnim leukemijama.
What are the risks associated with Trisenox?
Koji su rizici povezani s lijekom Trisenox?