FrancophonIA/ELRC3.0 huggingface dataset:
English: Fertility No clinical or non-clinical fertility studies have been conducted with TRISENOX.
Croatian: Nisu provedena klinička ili neklinička ispitivanja utjecaja TRISENOXA na plodnost.
English: Unused portions of each vial must be discarded properly.
Croatian: Neiskorišteni dio svake bočice mora se odložiti na ispravan način.
English: Musculoskeletal and connective tissue disorders Myalgia
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva mialgija
English: ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF TRISENOX SINCE NO PRESERVATIVE IS PRESENT.
Croatian: POTREBNO JE PRIDRŽAVATI SE STROGIH ZAHTJEVA ASEPTIČKE TEHNIKE TIJEKOM RUKOVANJA TRISENOXOM S OBZIROM DA LIJEK NE SADRŽI KONZERVANS.
English: Arsenic is excreted in human milk.
Croatian: Arsen se izlučuje u majčino mlijeko.
English: - If you have further questions, please ask your doctor, pharmacist or nurse.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: Each ampoule of 10 ml contains 10 mg of arsenic trioxide.
Croatian: Jedna ampula od 10 ml sadrži 10 mg arsenovog trioksida.
English: There are no studies in pregnant women using TRISENOX.
Croatian: Ispitivanja na trudnicama koje su uzimale TRISENOX nisu provedena.
English: TRISENOX must not be mixed with or concomitantly administered in the same intravenous line with other medicinal products.
Croatian: TRISENOX se ne smije miješati ili davati istodobno s drugim lijekovima kroz istu intravensku liniju.
English: Since no data are available across all renal impairment groups, caution is advised in the use of TRISENOX in patients with renal impairment.
Croatian: S obzirom da ni za jednu skupinu s oštećenjem bubrega nema dostupnih podataka, potreban je oprez kod primjene TRISENOXA u bolesnika s oštećenjem bubrega.
English: In one patient induction treatment was terminated because of severe prolongation of the QTc interval and electrolyte abnormalities on day 3.
Croatian: U jednog bolesnika indukcijsko je liječenje bilo prekinuto zbog jako produljenog QTc intervala i poremećaja elektrolita 3. dana.
English: Hydrochloric acid (for pH adjustment) Water for injections
Croatian: 6.1 Popis pomoćnih tvari natrijev hidroksid kloridna kiselina (za podešavanje pH) voda za injekcije
English: In vitro enzymatic studies with human liver microsomes revealed that arsenic trioxide has no inhibitory activity on substrates of the major cytochrome P450 enzymes such as 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5, 4A9/11.
Croatian: Enzimatska in vitro ispitivanja na humanim jetrenim mikrosomima otkrila su da arsenov trioksid ne posjeduje inhibitornu aktivnost spram supstrata najvažnijih enzima citokroma P450 poput 1A2, 2A6,
English: Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) Induction treatment schedule
Croatian: Novodijagnosticirana akutna promijelocitna leukemija (APL) niskog do srednjeg rizika
English: TRISENOX at 0.15 mg/kg daily until CR. During consolidation, ATRA was given at the same dose for periods of 2 weeks on and 2 weeks off for a total of 7 courses, and TRISENOX was given at the same dose 5 days per week, 4 weeks on and 4 weeks off, for a total of 4 courses.
Croatian: Tijekom konsolidacije, ATRA se davala u istoj dozi tijekom razdoblja od 2 tjedna nakon čega su slijedila 2 tjedna pauze, u ukupno 7 ciklusa, a TRISENOX se davao u istoj dozi 5 dana u tjednu tijekom 4 tjedna, nakon čega su slijedila 4 tjedna pauze, u ukupno 4 ciklusa.
English: IV use after dilution
Croatian: Intravenski nakon razrjeđivanja
English: *In the CALGB study C9710, 2 cases of grade ≥3 increased GGT were reported out of the 200 patients who received TRISENOX consolidation cycles (cycle 1 and cycle 2) versus none in the control arm.
Croatian: *U ispitivanju CALGB C9710, 2 slučaja stupnja ≥ 3 povećane GGT prijavljena su između 200
English: Excipients: sodium hydroxide, hydrochloric acid, water for injections
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: natrijev hidroksid, kloridna kiselina, voda za injekcije
English: Single centre pilot trial N with CR = 11
Croatian: Monocentrično pilot ispitivanje Bolesnici s potpunom remisijom = 11
English: General disorders and administration site conditions Pyrexia
Croatian: Opći poremećaji i reakcije na mjestu primjene pireksija
English: Fertility studies have not been conducted with TRISENOX.
Croatian: S TRISENOXOM nisu provedena ispitivanja plodnosti.
English: Marketing Authorisation Holder Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands
Croatian: Teva B.V., Swensweg 5, 2031 GA Haarlem, Nizozemska
English: If you have any further question on the use of this medicine, ask your doctor, pharmacist or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: TRISENOX 1 mg/ml concentrate for solution for infusion 4 years.
Croatian: TRISENOX 1 mg/ml koncentrat za otopinu za infuziju 4 godine.
English: TRISENOX 1 mg/ml concentrate for solution for infusion TRISENOX 2 mg/ml concentrate for solution for infusion
Croatian: TRISENOX 1 mg/ml koncentrat za otopinu za infuziju TRISENOX 2 mg/ml koncentrat za otopinu za infuziju
English: Blood and lymphatic system disorders Febrile neutropenia
Croatian: Poremećaji krvi i limfnog sustava febrilna neutropenija leukocitoza neutropenija pancitopenija trombocitopenija anemija leukopenija limfopenija
English: The daily dose can be escalated back to 100 % of the original dose if no prolongation occurs.
Croatian: Dnevna doza može se ponovno povisiti na 100%
English: Each carton contains 10 single-use glass ampoules.
Croatian: Jedna kutija sadrži 10 staklenih ampula za jednokratnu primjenu.
English: How to store TRISENOX
Croatian: Kako čuvati TRISENOX
English: Each carton contains 10 single-use glass vials.
Croatian: Jedna kutija sadrži 10 staklenih bočica za jednokratnu primjenu.
English: Preparation of TRISENOX
Croatian: Priprema TRISENOXA
English: Each vial of 6 ml contains 12 mg of arsenic trioxide.
Croatian: Jedna bočica od 6 ml sadrži 12 mg arsenovog trioksida.
English: Present
Croatian: Prisutno
English: In clinical trials, in the relapsed/refractory setting, 40 % of patients treated with TRISENOX experienced at least one QT corrected (QTc) interval prolongation greater than 500 msec. Prolongation of the QTc was observed between 1 and 5 weeks after TRISENOX infusion, and then returned to baseline by the end of 8 weeks after TRISENOX infusion.
Croatian: U kliničkim ispitivanjima bolesti u fazi relapsa/refraktorne na liječenje, 40% bolesnika liječenih TRISENOXOM iskusilo je najmanje jedan korigirani produžetak QT (QTc) intervala veći od 500 ms.
English: Cardiac failure
Croatian: Oštećenje bubrega
English: Use of TRISENOX
Croatian: Uporaba TRISENOXA
English: TRISENOX 2 mg/ml concentrate for solution for infusion Each ml of concentrate contains 2 mg of arsenic trioxide.
Croatian: TRISENOX 2 mg/ml koncentrat za otopinu za infuziju Jedan ml koncentrata sadrži 2 mg arsenovog trioksida.
English: Those serious adverse reactions attributed to arsenic trioxide included APL differentiation syndrome (3), leucocytosis (3), prolonged QT interval (4, 1 with torsade de pointes), atrial fibrillation/atrial flutter (1), hyperglycaemia (2) and a variety of serious adverse reactions related to haemorrhage, infections, pain, diarrhoea, nausea.
Croatian: Te ozbiljne nuspojave pripisane arsenovom trioksidu uključivale su sindrom diferencijacije APL-a (3), leukocitozu (3), produljeni QT interval (4, 1 s torsade de pointes),
English: Leukocyte activation syndrome (APL differentiation syndrome) 27 % of patients with APL, in the relapsed/refractory setting, treated with arsenic trioxide have experienced symptoms similar to a syndrome called the retinoic-acid-acute promyelocytic leukaemia (RA-APL) or APL differentiation syndrome, characterised by fever, dyspnoea, weight gain, pulmonary infiltrates and pleural or pericardial effusions, with or without leucocytosis.
Croatian: U 27% bolesnika s APL-om koji je u fazi relapsa/refraktoran na liječenje i koji su liječeni arsenovim trioksidom pojavili su se simptomi slični sindromu zvanom sindrom retinoatne kiseline u akutnoj promijelocitnoj leukemiji (RA-APL) ili sindrom diferencijacije APL-a, koji karakteriziraju vrućica,
English: Patients in the ATRA + chemotherapy treatment group received IV idarubicin at 12 mg/m2 on days 2, 4, 6, and 8 and oral ATRA at 45 mg/m2 daily until CR. During consolidation, patients received idarubicin at 5 mg/m2 on days 1 to 4 and ATRA at 45 mg/m2 daily for 15 days, then IV mitoxantrone at 10 mg/m2 on days 1
Croatian: Tijekom konsolidacije bolesnici su primali idarubicin u dozi od 5 mg/m2 tijekom 1.- 4. dana i ATRA-u u dozi od 45 mg/m2 dnevno tijekom 15 dana, potom u venu mitoksantron u dozi od 10 mg/m2 tijekom 1.5. dana i ATRA-u ponovno u dozi od 45 mg/m2 dnevno tijekom 15 dana i konačno jednu dozu idarubicina od 12 mg/m2 i ATRA-e od 45 mg/m2 dnevno tijekom 15 dana.
English: Because of the potential for serious adverse reactions in breast-feeding infants and children from TRISENOX, breast-feeding must be discontinued prior to and throughout administration.
Croatian: Prije i tijekom primjene TRISENOXA mora se prekinuti dojenje zbog mogućnosti nastanka ozbiljnih nuspojava u dojenčadi i djece.
English: Encephalopathy, Wernicke encephalopathy
Croatian: Vrlo često konvulzija encefalopatija, Wernickeova encefalopatija
English: Each ml of concentrate contains 1 mg of arsenic trioxide.
Croatian: Jedan ml koncentrata sadrži 1 mg arsenovog trioksida.
English: The infusion duration may be extended up to 4 hours if vasomotor reactions are observed.
Croatian: Trajanje infuzije može se produljiti do
English: The inorganic, lyophilized form of arsenic trioxide, when placed into solution, immediately forms the hydrolysis product arsenious acid (AsIII).
Croatian: 5.2 Farmakokinetička svojstva Anorganski, liofilizirani oblik arsenovog trioksida odmah stvara hidrolitički produkt arsenične kiseline
English: TRISENOX 2 mg/ml concentrate for solution for infusion 3 years.
Croatian: TRISENOX 2 mg/ml koncentrat za otopinu za infuziju 3 godine.
English: Eye disorders Vision blurred
Croatian: Poremećaji oka zamućeni vid
English: Undesirable effects are listed in table 2 below as MedDRA preferred term by system organ class and frequencies observed during TRISENOX clinical trials in 52 patients with refractory/relapsed APL. Frequencies are defined as: (very common ≥ 1/10), (common ≥ 1/100 to < 1/10), (uncommon ≥ 1/1,000 to < 1/100), not known (cannot be estimated from available data).
Croatian: Učestalosti se definiraju kao: (vrlo često ≥ 1/10), (često ≥ 1/100 i < 1/10), (manje često ≥ 1/1000 i
English: Negative Positive Not evaluable
Croatian: Ne može se procijeniti
English: Cytogenetics after TRISENOX therapy Table 5
Croatian: Citogenetika nakon terapije TRISENOXOM
English: Each ml of concentrate contains 2 mg of arsenic trioxide.
Croatian: Jedan ml koncentrata sadrži 2 mg arsenovog trioksida.
English: - fatigue (weariness), pain, fever, headache
Croatian: - otežano disanje - kašalj - bolovi u prsima
English: Each pack contains 10 vials.
Croatian: Jedno pakiranje sadrži 10 bočica.
English: Pleural effusion
Croatian: Mjera ishoda
English: Multicentre trial N with CR = 34
Croatian: Multicentrično ispitivanje Bolesnici s potpunom remisijom = 34
English: • some types of antiarrhythmics (medicines used to correct irregular heart beats, e.g. quinidine, amiodarone, sotalol, dofetilide)
Croatian: primjerice kinidin, amiodaron, sotalol, dofetilid)
English: Very Common Very Common
Croatian: Vrlo često umor
English: - nausea, vomiting, diarrhoea - dizziness, muscle pain, numbness or tingling - rash or itching, increased blood sugar, oedema (swelling due to excess fluid) - shortness of breath, fast heart beat, abnormal ECG heart tracing - reduced potassium or magnesium in the blood, liver function tests abnormal including presence of excess bilirubin or gamma-glutamyltransferase in the blood
Croatian: Vrlo često (javljaju se u više od jedne na 10 osoba): - umor (klonulost), bol, vrućica, glavobolja - mučnina, povraćanje, proljev - omaglica, bolovi u mišićima, obamrlost ili trnci - osip ili svrbež, povećana razina šećera u krvi, oticanje (oteklina zbog viška tekućine) - zadihanost, ubrzani srčani otkucaji, poremećeni EKG nalaz srca - smanjene razine kalija ili magnezija u krvi, poremećeni testovi jetrene funkcije uključujući prisutnost viška bilirubina ili gama- glutamiltransferaze u krvi
English: Cases of encephalopathy were reported with treatment with arsenic trioxide.
Croatian: Uz liječenje arsenovim trioksidom zabilježeni su slučajevi encefalopatije.
English: Relapsed/refractory APL
Croatian: APL u fazi relapsa/refraktoran na liječenje
English: Almac Pharma Services (Ireland) Limited; Finnabair Industrial Estate, Dundalk, Co. Louth, A91 P9KD, Ireland
Croatian: Almac Pharma Services (Ireland) Limited; Finnabair Industrial Estate, Dundalk, Co.
English: How TRISENOX is given
Croatian: Kako se daje TRISENOX
English: The plasma clearance of AsIII in patients with severe renal impairment (creatinine clearance less than 30 ml/min)
Croatian: Plazmatski klirens AsIII u bolesnika s teškim oštećenjem bubrega (klirens kreatinina manji od 30 ml/min) bio je 40% niži u usporedbi s bolesnicima normalne bubrežne funkcije (vidjeti dio 4.4).
English: TRISENOX 1 mg/ml concentrate for solution for infusion arsenic trioxide
Croatian: TRISENOX 1 mg/ml koncentrat za otopinu za infuziju arsenov trioksid
English: - reduction in blood cell counts (platelets, red and/or white blood cells), increased white blood cells - chills, increased weight - a fever due to an infection and low levels of white blood cells, herpes zoster infection - chest pain, bleeding in the lung, hypoxia (low oxygen level), collection of fluid around the heart or the lung, low blood pressure, abnormal heart rhythm - fit, joint or bone pain, inflammation of the blood vessels - increased sodium or magnesium, ketones in the blood and urine (ketoacidosis), renal function tests abnormal, kidney failure - stomach (abdominal) ache - redness of the skin, swollen face, blurred vision
Croatian: - zimica, povećana tjelesna težina - vrućica zbog infekcije i niskih razina bijelih krvnih stanica, infekcija herpesom zosterom - bolovi u prsima, krvarenje u plućima, hipoksija (niska razina kisika), nakupljanje tekućine oko srca ili pluća, nizak krvni tlak, poremećeni srčani ritam
English: Wernicke encephalopathy after arsenic trioxide treatment was reported in patients with vitamin B1 deficiency.
Croatian: U bolesnika s manjkom vitamina B1 zabilježena je Wernickeova encefalopatija nakon liječenja arsenovim trioksidom.
English: Patients with newly diagnosed acute promyelocytic leukaemia Your doctor will give you TRISENOX once every day as an infusion.
Croatian: Liječnik će Vam dati TRISENOX svakog dana kao infuziju.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION TRISENOX 1 mg/ml concentrate for solution for infusion Each ml of concentrate contains 1 mg of arsenic trioxide.
Croatian: TRISENOX 1 mg/ml koncentrat za otopinu za infuziju Jedan ml koncentrata sadrži 1 mg arsenovog trioksida.
English: In a phase 3, multicentre, non-inferiority trial comparing all-trans-retinoic acid (ATRA) plus chemotherapy with ATRA plus arsenic trioxide in newly diagnosed low-to-intermediate risk APL patients (Study APL0406; see also section 5.1), serious adverse reactions including hepatic toxicity, thrombocytopenia, neutropenia and QTc prolongation were observed in patients treated with arsenic trioxide.
Croatian: U multicentričnom ispitivanju neinferiornosti faze 3 u kojem je uspoređena primjena kombinacije sve-trans-retinoatne kiseline (ATRA) i kemoterapije s primjenom kombinacije ATRA-e i arsenovog trioksida u novodijagnosticiranih bolesnika s APL-om niskog do srednjeg rizika (ispitivanje APL0406;
English: - lung infection, infection in the blood - inflammation of the lungs which causes chest pain and breathlessness, cardiac failure - dehydration, confusion - Cerebral disease (Encephalopathy, Wernicke encephalopathy) with various manifestations including difficulties to use arms and legs, speech disorders and confusion
Croatian: - bolest mozga (encefalopatija, Wernickeova encefalopatija) koja se iskazuje na raznolike načine uključujući otežano korištenje ruku i nogu, poremećaje govora i smetenost
English: Hydroxyurea
Croatian: Biotransformacija
English: What TRISENOX looks like and contents of the pack - TRISENOX is a concentrate for solution for infusion (sterile concentrate).
Croatian: - TRISENOX je koncentrat za otopinu za infuziju (sterilni koncentrat).
English: TRISENOX 2 mg/ml concentrate for solution for infusion arsenic trioxide
Croatian: TRISENOX 2 mg/ml koncentrat za otopinu za infuziju arsenov trioksid
English: Relapsed/refractory acute promyelocytic leukaemia (APL) Induction treatment schedule
Croatian: Akutna promijelocitna leukemija (APL) koja je u fazi relapsa/refraktorna na liječenje Raspored indukcijskog liječenja
English: Tell your doctor or nurse straight away if you notice one or more of the following side effects, as these may be signs of allergic reaction: - difficulty in breathing - fever - sudden weight gain - water retention - fainting - palpitations (strong heartbeat you can feel in your chest)
Croatian: - iznenadni porast tjelesne težine - zadržavanje vode - nesvjestica - palpitacije (snažni otkucaji srca koje možete osjetiti u prsima)
English: TRISENOX 1 mg/ml concentrate for solution for infusion Type I borosilicate glass ampoule containing 10 ml of concentrate.
Croatian: TRISENOX 1 mg/ml koncentrat za otopinu za infuziju Ampula od borosilikatnog stakla tipa
English: Name and address of the manufacturer responsible for batch release
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Pulmonary alveolar haemorrhage
Croatian: Herpes zoster sepsa pneumonija
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 10 mg/10 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/204/002
Croatian: EU/1/02/204/002
English: Dilution of TRISENOX
Croatian: Razrjeđivanje TRISENOXA
English: OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
Croatian: OD LIJEKA, AKO JE POTREBNO
English: 3 months.
Croatian: 15 dana svaka 3 mjeseca.
English: Abdominal pain
Croatian: Vrlo često bolovi u abdomenu
English: NAME OF THE MEDICINAL PRODUCT TRISENOX 2 mg/ml concentrate for solution for infusion arsenic trioxide
Croatian: Uputa o lijeku: Informacije za bolesnika TRISENOX 2 mg/ml koncentrat za otopinu za infuziju arsenov trioksid
English: APPROPRIATE
Croatian: Pozitivno
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/204/001
Croatian: EU/1/02/204/001
English: The median age in the multicentre study was 40 years (age range 5 to 73).
Croatian: godina (raspon dobi od 5 do 73 godine).
English: Gamma-glutamyltransferase increased*
Croatian: Vrlo često hiperbilirubinemija porast kreatinina u krvi porast tjelesne težine porast gama-glutamiltransferaze*
English: Nausea
Croatian: Dojenje
English: Prior to initiating therapy with TRISENOX, a 12-lead ECG must be performed and serum electrolytes (potassium, calcium, and magnesium) and creatinine must be assessed; pre-existing electrolyte abnormalities must be corrected and, if possible, medicinal products that are known to prolong the QT interval must be discontinued.
Croatian: (kalij, kalcij i magnezij) te kreatinin; postojeće abnormalnosti u elektrolitima moraju se korigirati i,
English: Electrocardiogram QT prolonged
Croatian: Vrlo često produljenje QT intervala elektrokardiograma
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION TRISENOX 1 mg/ml sterile concentrate arsenic trioxide
Croatian: Uputa o lijeku: Informacije za bolesnika TRISENOX 1 mg/ml koncentrat za otopinu za infuziju arsenov trioksid
English: Not known (frequency cannot be estimated from the available data): - lung infection, infection in the blood - inflammation of the lungs which causes chest pain and breathlessness, cardiac failure - dehydration, confusion - Cerebral disease (Encephalopathy, Wernicke encephalopathy) with various manifestations including difficulties to use arms and legs, speech disorders and confusion
Croatian: - crvenilo kože, natečeno lice, zamućeni vid Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka): - infekcija pluća, infekcija u krvi - upala pluća koja uzrokuje bol u prsima i nedostatak zraka, zatajenje srca
English: to 5 and ATRA again at 45 mg/m2 daily for 15 days, and finally a single dose of idarubicin at 12 mg/m2 and ATRA at 45 mg/m2 daily for 15 days.
Croatian: ATRA u dozi 45 mg/m2 dnevno, a u venu TRISENOX u dozi 0,15 mg/kg dnevno do potpune remisije.
English: Gastrointestinal disorders Diarrhoea
Croatian: Poremećaji probavnog sustava proljev
English: Table 1 Recommendation for initiation of hydroxyurea WBC
Croatian: Tablica 1 Preporuka za započinjanje liječenja hidroksiurejom broj bijelih krvnih stanica hidroksiureja 10-50 x 103/µl
English: Patients in the ATRA + TRISENOX treatment group received oral ATRA at 45 mg/m2 daily and IV
Croatian: Bolesnici u skupini liječenoj kombinacijom ATRA+kemoterapija primali su u intravenski idarubicin u dozi od 12 mg/m2
English: If your doctor or nurse gives you more TRISENOX than he/she should You may experience convulsions, muscle weakness and confusion.
Croatian: Možete osjetiti konvulzije, slabost u mišićima i smetenost.
English: Fluid retention
Croatian: Prijavljivanje nuspojava
English: In newly diagnosed patients with low to intermediate risk APL 63.2 % developed grade 3 or 4 hepatic toxic effects during induction or consolidation treatment with arsenic trioxide in combination with ATRA (see section 4.8).
Croatian: 3. ili 4. stupanj hepatotoksičnih učinaka tijekom indukcijskog ili konsolidacijskog liječenja arsenovim trioksidom u kombinaciji s ATRA-om (vidjeti dio 4.8).
English: Hypotension
Croatian: Plodnost
English: Special populations Hepatic impairment
Croatian: Krvožilni poremećaji vaskulitis hipotenzija
English: The treatment may be repeated every three months depending on the patient's symptoms.
Croatian: Terapiju treba ponoviti svaka tri mjeseca ovisno o simptomima bolesnika.
English: It contains the active substance capsaicin (8%).
Croatian: Sadrži djelatnu tvar kapsaicin (8%).
English: It can be used alone or together with other medicines for pain.
Croatian: Može se koristiti samostalno ili zajedno s drugim lijekovima protiv boli.
English: This summary was last updated in 08-2015.
Croatian: Sažetak je posljednji put ažuriran u 08. 2015.
English: Qutenza capsaicin
Croatian: Qutenza kapsaicin
English: It is applied to the most painful areas of the skin.
Croatian: Primjenjuje se na najbolnija područja kože.
English: Qutenza should remain in place for 30 minutes for the feet and 60 minutes for other parts of the body.
Croatian: Qutenza treba ostati zalijepljen 30 minuta na stopalima i 60 minuta na drugim dijelovima tijela.
English: Because of this, healthcare professionals should wear nitrile gloves while applying and removing the patch.
Croatian: Zbog toga, zdravstveni djelatnici trebaju nositi nitrilne rukavice prilikom primjene i uklanjanja flastera.
English: The painful area should be determined by a doctor and marked on the skin.
Croatian: Liječnik treba odrediti bolno područje i označiti ga na koži.
English: Patches can be cut to match the area to cover.
Croatian: Flasteri se mogu izrezati tako da odgovaraju području koje pokrivaju.
English: It stimulates the ‘transient receptor potential vanilloid 1' (TRPV1) receptor which is found in the nerves in the skin that detect pain.
Croatian: Stimulira "prolazni receptorski potencijal vaniloidnog receptora 1" (TRPV1) koji se nalazi u živcima u koži koji otkrivaju bol.
English: In addition, the company that makes Qutenza will make sure that an educational programme is available for healthcare professionals who will prescribe Qutenza.
Croatian: Nadalje, tvrtka koja proizvodi lijek Qutenza osigurat će da su edukacijski programi dostupni zdravstvenim djelatnicima koji propisuju lijek Qutenza.