natgillin/translations-raw huggingface dataset:
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?
The main measure of effectiveness in all main studies was the reduction in the 24-hour pain score during an eight- or 12-week period after application of the patch.
Glavno merilo učinkovitosti v vseh glavnih študijah je bilo zmanjšanje 24-urnega točkovanja bolečine v osem- ali dvanajsttedenskem obdobju po nanosu obliža.
Qutenza can cause a burning sensation on the skin.
Zdravilo Qutenza lahko povzroči pekoč občutek na koži.
A fifth study compared Qutenza with a placebo (dummy) patch in 369 patients with painful peripheral diabetic neuropathy, a form of neuropathic pain associated with diabetes; a supportive study looked at repeated treatment over one year.
V peti študiji so zdravilo Qutenza primerjali s placebom (obližem brez zdravilne učinkovine) pri 369 bolnikih z bolečo diabetično periferno nevropatijo, tj. obliko nevropatske bolečine, povezane s sladkorno boleznijo; v podporni študiji so proučevali ponavljajoče se zdravljenje v enem letu.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Qutenza.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Patches can be cut to match the area to cover.
Obliž je mogoče razrezati, da ustreza velikosti predela, ki ga bo prekrival.
Alternatively, medicines for pain may be taken.
Lahko pa se vzamejo tudi protibolečinska zdravila.
Qutenza is used to treat peripheral neuropathic pain (pain that is caused by damage to the nerves) in adults.
Zdravilo Qutenza se uporablja za zdravljenje periferne nevropatske bolečine (bolečine, ki jo povzroča poškodba živcev) pri odraslih osebah.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Qutenza, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
For the full list of all side effects and restrictions with Qutenza, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Qutenza glejte navodilo za uporabo.
What is the risk associated with Qutenza?
Kakšna tveganja so povezana z zdravilom Qutenza?
The active substance in Qutenza, capsaicin, is a substance normally found in chilli peppers.
Zdravilna učinkovina v zdravilu Qutenza, kapsaicin, je snov, ki jo najdemo v papriki čili.
The most common side effects with Qutenza (seen in more than 1 patient in 10) are pain and redness at the site of application.
Najpogostejša neželena učinka zdravila Qutenza (opažena pri več kot 1 bolniku od 10) sta bolečina in pordelost na mestu nanosa.
Why has Qutenza been approved?
Zakaj je bilo zdravilo Qutenza odobreno?
Before applying Qutenza, the area may be treated with a local anaesthetic to numb it; this helps to reduce discomfort.
Pred nanosom zdravila Qutenza se lahko na predel nanese lokalni anestetik, da omrtvi, kar zmanjša neugodje.
Qutenza was more effective at reducing neuropathic pain than the control patches.
Zdravilo Qutenza je bilo pri zmanjševanju nevropatske bolečine učinkovitejše od kontrolnih obližev.
In the two studies of patients with post-herpetic neuralgia, the reduction in pain scores after eight weeks was 30 and 32% in patients who were given Qutenza, compared with 20 and 24% in patients who received the control patches.
V dveh študijah bolnikov s postherpetično nevralgijo je bilo zmanjšanje točkovanja bolečine po osmih tednih 30 in 32 % pri bolnikih, ki so prejemali zdravilo Qutenza, v primerjavi z 20 in 24 % pri bolnikih, ki so prejeli kontrolne obliže.