natgillin/translations-raw huggingface dataset:
Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) Induction treatment schedule 
Na novo diagnosticirana akutna promielocitna levkemija (APL) z nizkim do srednjim tveganjem Program indukcijskega zdravljenja
TRISENOX has been investigated in 77 newly diagnosed patients with low to intermediate risk APL, in a controlled, randomized, non-inferiority Phase 3 clinical study comparing the efficacy and safety of TRISENOX combined with all-trans-retinoic acid (ATRA) with those of ATRA + chemotherapy (eg, idarubicin and mitoxantrone) (Study APL0406). 
Na novo diagnosticirani bolniki z APL, pri katerih tveganje ni veliko Zdravilo TRISENOX so raziskovali pri 77 na novo diagnosticiranih bolnikih z APL z nizkim do srednjim tveganjem v nadzorovani, randomizirani, neinferiorni klinični študiji 3. faze, v kateri so primerjali učinkovitost in varnost zdravila TRISENOX v kombinaciji z vse-trans-retinojsko kislino
3 months. 
15 dni.
TRISENOX contains sodium 
Zdravilo TRISENOX vsebuje natrij
Duration and frequency of treatment 
Kako se daje zdravilo TRISENOX Trajanje in pogostnost zdravljenja
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. 
mitoksantron v odmerku 10 mg/m2 ob dneh 1 do 5 in znova ATRA v odmerku 45 mg/m2 dnevno 15 dni ter na koncu en odmerek idarubicina 12 mg/m2 in ATRA v odmerku 45 mg/m2 dnevno
Each course of consolidation was initiated at haematological recovery from the previous course defined as absolute neutrophil count > 1.5 × 109/l and platelets > 100 × 109/l. 
določenem kot absolutno število nevtrofilcev > 1,5×10
If syncope, rapid or irregular heartbeat develops, the patient must be hospitalised and monitored continuously, serum electrolytes must be assessed, TRISENOX therapy must be temporarily discontinued until the QTc interval regresses to below 460 msec, electrolyte abnormalities are corrected, and the syncope and irregular heartbeat cease. 
začasno morate prekiniti zdravljenje z zdravilom TRISENOX, dokler se trajanje intervala Q-Tc ne vrne pod 460 ms, se anomalije ravni elektrolitov ne popravijo in sinkopa in nepravilen srčni utrip ne prenehata.
- 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 
- omotica, mišične bolečine, odrevenelost ali mravljinčenje - izpuščaji ali srbečica - zvišana raven sladkorja v krvi, edem (oteklina zaradi prevelike količine tekočine) - zasoplost, hiter srčni utrip, nenormalen EKG - znižana koncentracija kalija ali magnezija v krvi, neobičajni rezultati testov delovanja jeter,
There did not appear to be a relationship between baseline white blood cell (WBC) counts and development of hyperleucocytosis nor did there appear to be a correlation between baseline WBC count and peak WBC counts. 
Ni ugotovljene povezave med osnovno vrednostjo števila belih krvnih celic (WBC - white blood cell) in razvojem hiperlevkocitoze ali med osnovno in najvišjo vrednostjo WBC. Hiperlevkocitoze niso nikoli zdravili z dodatno kemoterapijo in ob nadaljevanju zdravljenja z zdravilom TRISENOX ni bila ozdravljena.
Serious adverse reactions were common (1-10 %) and not unexpected in the relapsed/refractory population. 
V tej skupini z APL v relapsu ali refraktarni fazi so bili resni neželeni učinki pogosti (1-10 %) in pričakovani.
Thereafter, in absence of worsening of the previous toxicity, TRISENOX should be resumed at full dosage. 
Če se prejšnja toksičnost ne poslabša, nadaljujte zdravljenje s polnim odmerkom zdravila TRISENOX.
to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8 °C, unless dilution has taken place in controlled and validated aseptic conditions. 
Če ni porabljeno takoj, je uporabnik odgovoren za čas in pogoje hranjenja pred uporabo in ti ne bi smeli trajati dlje kot 24 ur pri temperaturi med 2-8 °C, razen če se redčenje ni opravilo v nadzorovanih in preverjeno aseptičnih pogojih.
Fertility No clinical or non-clinical fertility studies have been conducted with TRISENOX. 
Zdravila TRISENOX niso preskušali v kliničnih ali predkliničnih študijah plodnosti.
PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). 
- Zdravilo TRISENOX je koncentrat za raztopino za infundiranje (sterilni koncentrat).
Pleuritic pain 
OVOJNINAH AMPULA
The multicentre trial included 5 paediatric patients (< 18 years old), 3 of whom achieved CR. No children of less than 5 years of age were treated. 
Pri obeh je prišlo do CR. Multicentrična študija je vključevala 5 pediatričnih bolnikov (starih < 18 let).
TRISENOX 2 mg/ml concentrate for solution for infusion Each ml of concentrate contains 2 mg of arsenic trioxide. 
TRISENOX 2 mg/ml koncentrat za raztopino za infundiranje En ml koncentrata vsebuje 2 mg arzenovega trioksida.
Each vial of 6 ml contains 12 mg of arsenic trioxide. 
Ena viala s 6 ml vsebuje 12 mg arzenovega trioksida.
- 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 
- bolečine v prsih, krvavitev v pljučih, hipoksija (nizka raven kisika), nabiranje tekočine okoli srca ali pljuč, nizek krvni tlak, moten srčni ritem - konvulzije, bolečine v sklepih ali kosteh, vnetje krvnih žil - zvišana koncentracija natrija ali magnezija, ketonov v krvi in seču (ketoacidoza), neobičajni rezultati testov delovanja ledvic, ledvična odpoved - bolečine v trebuhu (abdomnu)
Each ml of concentrate contains 1 mg of arsenic trioxide. 
En ml koncentrata vsebuje 1 mg arzenovega trioksida.
Patients with newly diagnosed APL confirmed by the presence of t(15; 17) or PML-RARα by RT-PCR or micro speckled PML nuclear distribution in leukaemic cells were included. 
Bolniki z na novo diagnosticirano APL, potrjeno s prisotnostjo t(15; 17) ali PML-RARα z
In order to prevent the development of the APL differentiation syndrome during induction treatment, prednisone (0.5 mg/kg body weight per day throughout induction treatment) may be administered from day 1 of TRISENOX application to the end of induction therapy in APL patients. 
Za preprečitev nastanka sindroma diferenciacije APL med indukcijskim zdravljenjem, lahko odmerite prednizon (0,5 mg/kg telesne mase na dan med indukcijskim zdravljenjem) od 1. dne odmerjanja zdravila TRISENOX do konca indukcijskega zdravljenja pri bolnikih z APL. Priporočamo, da med zdravljenjem s steroidi ne začnete kemoterapije, kajti nimamo izkušenj s skupno uporabo steroidov in kemoterapije med zdravljenjem sindroma aktivacije levkocitov, do katerega pride zaradi zdravila TRISENOX.
- if you are taking or have recently taken any medicine which may affect your liver. 
Zdravnika morate obvezno obvestiti o vseh zdravilih, ki jih uporabljate; - če jemljete ali ste pred kratkim jemali katero koli zdravilo, ki lahko vpliva na jetra.
Blood and lymphatic system disorders Febrile neutropenia 
Bolezni krvi in limfatičnega sistema febrilna nevtropenija levkocitoza nevtropenija pancitopenija trombocitopenija anemija levkopenija limfopenija
OTHER 
raz
TRISENOX 1 mg/ml concentrate for solution for infusion 4 years. 
TRISENOX 1 mg/ml koncentrat za raztopino za infundiranje 4 leta
Very common (may affect more than 1 in 10 people): - fatigue (weariness), pain, fever, headache 
Med zdravljenjem z zdravilom TRISENOX boste morda imeli nekatere od naštetih učinkov: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): - utrujenost (izčrpanost), bolečine, zvišana telesna temperatura, glavobol
At the first signs that could suggest the syndrome (unexplained fever, dyspnoea and/or weight gain, abnormal chest auscultatory findings or radiographic abnormalities), treatment with TRISENOX must be temporarily discontinued and high-dose steroids (dexamethasone 10 mg intravenously twice a day) must be immediately initiated, irrespective of the leukocyte count and continued for at least 3 days or longer until signs and symptoms have abated. 
TRISENOX začasno prekiniti in takoj začeti dajati visoke odmerke steroidov (deksametazon 10 mg intravensko dvakrat na dan) in z njimi nadaljevati vsaj 3 dni ali dlje, dokler bolezenski znaki ne izginejo, ne glede na število levkocitov.
If you are able to become pregnant, you must use effective birth control during treatment with TRISENOX. 
Če lahko zanosite, morate med zdravljenjem z zdravilom TRISENOX uporabljati zanesljivo kontracepcijsko sredstvo.
In the multicentre study 27 of 40 patients were alive with a median follow-up time of 16 months (range 9 to 25). 
V multicentrični študiji je bilo živih 27 od 40 bolnikov.
Each ml of concentrate contains 2 mg of arsenic trioxide. 
En ml koncentrata vsebuje 2 mg arzenovega trioksida.
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 10 vials 
koncentrat za raztopino za infundiranje 10 vial
TRISENOX 2 mg/ml concentrate for solution for infusion 3 years. 
TRISENOX 2 mg/ml koncentrat za raztopino za infundiranje 3 leta
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). 
≥ 1/100 do < 1/10), (občasni ≥1/1.000 do < 1/100), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Hydrochloric acid (for pH adjustment) Water for injections 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev hidroksid klorovodikova kislina (za uravnavanje pH) voda za injekcije
Musculoskeletal and connective tissue disorders Myalgia 
Bolezni mišično-skeletnega sistema in vezivnega tkiva mialgija zelo pogosti artralgija bolečine v kosteh
The following information is intended for medical or healthcare professionals only: 
Naslednje informacije so namenjene samo zdravstvenemu osebju: V ZDRAVILU NI KONZERVANSA, ZATO MORATE MED DELOM Z ZDRAVILOM
Pleural effusion 
Ledvična okvara
- 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 
- možganska bolezen (encefalopatija, Wernickejeva encefalopatija) z različnimi oblikami pojavljanja, vključno s težavami pri uporabi rok in nog, težavami z govorom in zmedenostjo
The plasma clearance of AsIII in patients with severe renal impairment (creatinine clearance less than 30 ml/min) 
Očistek AsIII v plazmi bolnikov s hudo okvaro delovanja ledvic (očistek kreatinina pod 30 ml/min) je bil 40 % nižji v primerjavi z bolniki z normalnim delovanjem ledvic (glejte poglavje 4.4).
QUALITATIVE AND QUANTITATIVE COMPOSITION TRISENOX 1 mg/ml concentrate for solution for infusion Each ml of concentrate contains 1 mg of arsenic trioxide. 
TRISENOX 1 mg/ml koncentrat za raztopino za infundiranje En ml koncentrata vsebuje 1 mg arzenovega trioksida.
NAME OF THE MEDICINAL PRODUCT TRISENOX 2 mg/ml concentrate for solution for infusion arsenic trioxide 
Navodilo za uporabo TRISENOX 2 mg/ml koncentrat za raztopino za infuzijo arzenov trioksid
During therapy with TRISENOX, potassium concentrations must be kept above 4 mEq/l and magnesium concentrations must be kept above 1.8 mg/dl. 
Med zdravljenjem z zdravilom TRISENOX morate vzdrževati koncentracijo kalija nad 4 mEq/l in koncentracijo magnezija nad 1,8 mg/dl. Bolnike, ki dosežejo absolutno vrednost intervala Q-T > 500 ms, morate ponovno pregledati in nemudoma ukrepati, da bi popravili morebitne spremljajoče dejavnike tveganja.
At last follow-up, 6 of 12 patients in the single institution study were alive with a median follow-up time of 28 months (range 25 to 29). 
Pri zadnjem pregledu je bilo živih 6 od 12 bolnikov iz študije z enim zavodom.
TRISENOX 1 mg/ml concentrate for solution for infusion arsenic trioxide 
TRISENOX 1 mg/ml koncentrat za raztopino za infundiranje arzenov trioksid
Do not use the preparation if foreign particulate matter is present. 
Če so v pripravku tuji delci, ga ne uporabljajte.
Relapsed/refractory acute promyelocytic leukaemia (APL) Induction treatment schedule 
Akutna promielocitna levkemija (APL) v relapsu ali refraktarni fazi
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. 
pri dojenčkih in otrocih morate z dojenjem prenehati pred uporabo in med njo.
Preparation of TRISENOX 
Redčenje zdravila TRISENOX
Patients with complete remission received consolidation therapy with TRISENOX for 25 additional doses over a 5 week period. 
Bolnikom s popolno remisijo so odredili konsolidacijsko zdravljenje z zdravilom TRISENOX.
Eye disorders Vision blurred 
Očesne bolezni zamegljen vid
TRISENOX 2 mg/ml concentrate for solution for infusion arsenic trioxide 
TRISENOX 2 mg/ml koncentrat za raztopino za infundiranje arzenov trioksid
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 
idarubicin v odmerku 12 mg/m2 ob dneh 2, 4, 6 in 8 ter peroralno ATRA v odmerku 45 mg/m2 dnevno do CR.
Each cycle consists of 20 doses given 5 days per week (followed by 2 days interruption) for 4 weeks followed by 4 weeks interruption. 
Če se bolezen odzove na zdravilo TRISENOX, boste opravili 4 dodatne cikle zdravljenja, En cikel je sestavljen iz 20 odmerkov, ki jih boste dobivali 5 dni v tednu (ki jim sledi 2-dnevna prekinitev) v obdobju 4 tednov, temu pa bo sledila 4-tedenska prekinitev.
Blood creatinine increased 
kalcija in kreatinina v krvi.
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) 
Nemudoma obvestite svojega zdravnika ali medicinsko sestro, če opazite enega ali več od naslednjih neželenih učinkov, saj so lahko znak alergične reakcije:
70 hours, respectively. 
ur in presnovka DMAV 70 ur.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULE 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
Pulmonary alveolar haemorrhage 
Žilne bolezni vaskulitis hipotenzija
Forty-four per cent of relapsed/refractory APL patients experienced symptoms that could be associated with neuropathy; most were mild to moderate and were reversible upon cessation of treatment with TRISENOX. 
44 odstotkov bolnikov z APL v relapsu ali refraktarni fazi je imelo simptome, ki jih lahko povežemo z nevropatijo.
It is recommended that chemotherapy not be added to treatment with steroids since there is no experience with administration of both steroids and chemotherapy during treatment of the leukocyte activation syndrome due to TRISENOX. 
Jetrna okvara Ker ni na voljo podatkov za nobeno skupino bolnikov z jetrno okvaro in lahko med zdravljenjem z zdravilom TRISENOX pride do hepatotoksičnih učinkov, se pri uporabi zdravila TRISENOX
Headache 
SERIJ
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. 
Zdravilo TRISENOX so dajali v enakem odmerku 5 dni na teden v času 4 tednov, ki so jim sledili 4 tedni brez odmerka, pri čemer so bili skupaj izvedeni 4 cikli.
Present 
Porazdelitev
Hyperbilirubinaemia 
OVOJNINAH VIALA 2 mg/ML
Treatment with TRISENOX must be temporarily interrupted before the scheduled end of therapy at any time that a toxicity grade 3 or greater on the National Cancer Institute Common Toxicity Criteria is observed and judged to be possibly related to TRISENOX treatment. 
Zamik, sprememba in ponovni začetek odmerjanja Zdravljenje z zdravilom TRISENOX morate pred načrtovanim koncem terapije začasno prekiniti v katerem koli trenutku, ko opazite toksičnost 3. stopnje po splošnih Merila pogostih toksičnosti
How to store TRISENOX 
Shranjevanje zdravila TRISENOX
Newly diagnosed non high risk APL patients 
Pri klinično nestabilnih bolnikih z APL je tveganje posebno visoko.
Pneumonitis 
Zdravilo
• some medicines to treat allergies such as hay fever, called antihistamines (e.g. terfenadine and astemizole) 
zdravila za zdravljenje psihoz (izguba stika z realnostjo, npr. tioridazin) zdravila proti depresiji (npr. amitriptilin) nekatere vrste zdravil za zdravljenje bakterijskih okužb (npr. eritromicin in sparfloksacin) nekatere vrste zdravil za zdravljenje alergij, kot je seneni nahod, imenovana antihistaminiki (npr. terfenadin in astemizol)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION TRISENOX 1 mg/ml sterile concentrate arsenic trioxide 
TRISENOX 1 mg/ml sterilni koncentrat arzenov trioksid i. v. uporaba po redčenju
ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF TRISENOX SINCE NO PRESERVATIVE IS PRESENT. 
Priprava zdravila TRISENOX V zdravilu ni konzervansa, zato morate med delom z zdravilom TRISENOX strogo upoštevati aseptične pogoje.
The treatment may be repeated every three months depending on the patient's symptoms. 
Zdravljenje je mogoče ponoviti vsake tri mesece glede na bolnikove simptome.
The painful area should be determined by a doctor and marked on the skin. 
Boleči predel mora določiti zdravnik in ga označiti na koži.
It contains the active substance capsaicin (8%). 
Vsebuje zdravilno učinkovino kapsaicin (8 %).
Because of this, healthcare professionals should wear nitrile gloves while applying and removing the patch. 
Zato morajo zdravstveni delavci med nanašanjem in odstranjevanjem obliža nositi nitrilne rokavice.
It can be used alone or together with other medicines for pain. 
Uporablja se lahko samostojno ali v kombinaciji z drugimi zdravili za lajšanje bolečin.
The European Commission granted a marketing authorisation valid throughout the European Union for Qutenza on 15 May 2009. 
Evropska komisija je dovoljenje za promet z zdravilom Qutenza, veljavno po vsej Evropski uniji, izdala 15. maja 2009.
The full EPAR for Qutenza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Qutenza je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It is applied to the most painful areas of the skin. 
Nanesti ga je treba na najbolj boleče predele kože.
What measures are being taken to ensure the safe and effective use of Qutenza? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Qutenza?
Qutenza should remain in place for 30 minutes for the feet and 60 minutes for other parts of the body. 
Zdravilo Qutenza mora učinkovati 30 minut na predelu stopal in 60 minut na drugih delih telesa.
This is a summary of the European public assessment report (EPAR) for Qutenza. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Qutenza.
The programme will include information on how to administer, handle and dispose of Qutenza and on warnings and precautions that should be considered during treatment. 
Program bo vseboval informacije o načinu dajanja zdravila Qutenza, ravnanju z njim in odlaganju ter opozorila in previdnostne ukrepe, ki jih je treba upoštevati med zdravljenjem.
It may take up to three weeks for Qutenza to have an effect. 
Traja lahko tudi tri tedne, preden začne zdravilo Qutenza učinkovati.
For more information about treatment with Qutenza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Qutenza preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
No more than four patches should be used on the patient at the same time. 
Bolnik lahko hkrati uporablja največ štiri obliže.
In addition, the company that makes Qutenza will make sure that an educational programme is available for healthcare professionals who will prescribe Qutenza. 
Družba, ki izdeluje zdravilo Qutenza, bo zagotovila, da bo v vseh državah članicah na voljo izobraževalni program za zdravstvene delavce, ki bodo predpisovali zdravilo Qutenza.
Other information about Qutenza 
Druge informacije o zdravilu Qutenza
Supportive data showed benefit when Qutenza was repeated over a 1-year period in combination with other treatments. 
Podporni podatki kažejo koristi zdravila Qutenza, kadar se je zdravljenje v enem letu ponovilo v kombinaciji z drugimi zdravljenji.
Qutenza can only be applied to unbroken, non-irritated, dry skin. 
Zdravilo Qutenza se lahko nanaša samo na nepoškodovano, nerazdraženo in suho kožo.
The rapid release of high doses of capsaicin from Qutenza overstimulates the TRPV1 receptors so they become less sensitive to the stimuli that normally cause neuropathic pain. 
Hitro sproščanje visokih odmerkov kapsaicina iz zdravila Qutenza pretirano spodbuja receptorje TRPV1, da ti postanejo manj občutljivi na dražljaje, ki običajno povzročajo nevropatsko bolečino.
A risk management plan has been developed to ensure that Qutenza is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Qutenza je bil pripravljen načrt obvladovanja tveganj.
Once the patch is removed, the area is cleaned using the cleansing gel provided. 
Po odstranitvi obliža je treba predel očistiti s priloženim čistilnim gelom.
The Committee for Medicinal Products for Human Use (CHMP) decided that Qutenza's benefits are greater than its risks and recommended that Qutenza be given marketing authorisation. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Qutenza večje od z njim povezanih tveganj, in je priporočil, da se zanj izda dovoljenje za promet.
Qutenza should be applied by a doctor or by a healthcare professional under the supervision of a doctor. 
Zdravilo Qutenza mora nanesti zdravnik ali zdravstveni delavec pod nadzorom zdravnika.
It stimulates the ‘transient receptor potential vanilloid 1' (TRPV1) receptor which is found in the nerves in the skin that detect pain. 
Spodbuja vaniloidni receptor 1 (TRPV1), ki je v živcih na koži, ki zaznavajo bolečino.
All of the patients had neuropathic pain due to either post-herpetic neuralgia (pain that occurs in people who have had shingles, an infection caused by the varicella zoster virus) or HIV-associated neuropathy (damage to the nerves caused by HIV infection). 
Vsi bolniki so imeli nevropatsko bolečino zaradi postherpetične nevralgije (bolečine, ki se pojavlja pri ljudeh, ki so preboleli pasovec, tj. okužbo, ki jo povzroča virus varicella zoster) ali nevropatije, povezane z virusom HIV (poškodbe živcev, ki jo povzroča okužba z virusom HIV).
What benefit has Qutenza shown during the studies? 
Kakšne koristi je zdravilo Qutenza izkazalo med študijami?