FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacokinetic data in humans showed transient, low (< 5 ng/ml) systemic exposure to capsaicin in about one third of PHN patients, in 3% of patients with painful diabetic peripheral neuropathyand in no HIV-AN patients following 60-minute applications of Qutenza.
Slovenian: Farmakokinetični podatki pri ljudeh po 60 minut trajajoči aplikaciji zdravila Qutenza so pokazali prehodno, nizko (< 5 ng/ml) sistemsko izpostavljenost kapsaicinu pri približno tretjini bolnikov z bolečo diabetično periferno nevropatijo (PHN), pri 3% bolnikov z bolečo diabetično nevropatijo in z bolečo nevropatijo, povezano s HIV.
English: The treatment area may be pre-treated with a topical anaesthetic or the patient may be administered an oral analgesic prior to application of Qutenza to reduce potential application related discomfort.
Slovenian: Zdravljeni predel bo morda potrebno pred aplikacijo zdravila Qutenza predhodno obdelati s topikalnim anestetikom ali pa bolniku predpisati peroralni analgetik, da se zmanjša morebitno neugodje pri aplikaciji.
English: No dose adjustment is required for patients with renal or hepatic impairment.
Slovenian: Pri bolnikih z okvaro ledvic ali jeter prilagoditev odmerka ni potrebna.
English: The cutaneous patch is stored in a paper coated aluminium foil sachet with polyacrylnitril layer.
Slovenian: Dermalni obliž se nahaja v vrečki iz s papirjem kaširane aluminijaste folije s poliakrilniltrilno plastjo.
English: The cleansing gel is supplied in a high density polyethylene tube with a polypropylene cap.
Slovenian: Čistilni gel je na voljo v tubi iz polietilena visoke gostote s polipropilensko zaporko.
English: Qutenza may be cut into smaller pieces to fit the treatment area.
Slovenian: Obliže Qutenza je mogoče razrezati na manjše kose, tako da se prilegajo zdravljenemu predelu.
English: Qutenza is indicated for the treatment of peripheral neuropathic pain in adults either alone or in combination with other medicines for the treatment of pain.
Slovenian: Zdravilo Qutenza je indicirano za zdravljenje periferne nevropatske bolečine pri odraslih osebah samostojno ali v kombinaciji z drugimi zdravili za lajšanje bolečin.
English: • Itching, bumps, blisters, swelling, dryness on the area where the patch is applied,burning sensation, pain in limbs.
Slovenian: • srbenje, bule, mehurčki, oteklina, suhost na mestu aplikacije obliža, pekoč občutek, bolečine v okončinah
English: Generally small, short-term changes in the ability to feel when something is hot or sharp have been seen after use of capsaicin.
Slovenian: Po uporabi kapsaicina so opazili majhne kratkotrajne spremembe sposobnosti zaznavanja vročega ali ostrega.
English: At the end of the Qutenza treatment your doctor or nurse will clean the treated skin with cleansing gel from a tube supplied with the kit.
Slovenian: Po aplikaciji zdravila Qutenza zdravnik ali medicinska sestra zdravljeni predel očisti s čistilnim gelom iz tube, ki je v kompletu.
English: In patients with painful diabetic peripheral neuropathy, a careful visual examination of the feet should be undertaken prior to each application of Qutenza and at subsequent clinic visits to detect skin lesions related to underlying neuropathy and vascular insufficiency.
Slovenian: Pri bolnikih z bolečo diabetično periferno nevropatijo je treba pred zdravljenjem z zdravilom Qutenza in na poznejših pregledih opraviti natančen pregled stopal, da bi odkrili kožne spremembe, povezane z osnovno nevropatijo in žilno insuficienco.
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov izdelovalca(ev) zdravila, odgovornega(ih) za sproščanje serije
English: If you accidentally touch the Qutenza patch or treated skin before cleansing gel is applied it may burn and/or sting.
Slovenian: Če se nehote dotaknete obliža Qutenza ali zdravljene kože pred nanosom čistilnega gela, lahko nastane pekoč in/ali zbadajoč občutek.
English: Particular attention should be given to diabetic patients with comorbidities of coronary artery disease, hypertension and cardiovascular autonomic neuropathy
Slovenian: Posebno pozornost je treba nameniti sladkornim bolnikom, ki imajo sočasno bolezen koronarnih arterij, hipertenzijo ali kardiovaskularno avtonomno nevropatijo;
English: A section of the release liner should be peeled and folded and the adhesive side of the printed patch placed on the treatment area.
Slovenian: Zaščitno podlogo je treba odlepiti in zapogniti ter lepljivo stran potiskanega obliža aplicirati na zdravljeni predel.
English: • to be aware of the risk of reductions in sensory function which are generally minor and temporary (including to thermal and sharp stimuli) following administration of Qutenza
Slovenian: • poznavanju tveganja, da se po uporabi zdravila Qutenza pojavijo zmanjšanja senzorične funkcije, ki so na splošno blaga in prehodna (vključno z občutljivostjo za dražljaje s toploto in ostrino)
English: This may result in transient erythema and burning sensation (with mucous membranes being particularly susceptible), eye pain, eye and throat irritation and cough.
Slovenian: Ob izpostavljenosti kože kapsaicinu se pojavijo prehodni eritemi in pekoč občutek (posebno občutljive so sluznice), bolečine v očesu, draženje oči in žrela ter kašelj.
English: Apply topical anaesthetic to treatment area.
Slovenian: Na zdravljeni predel nanesite topikalni anestetik.
English: Topical anaesthetics should be removed prior to applying Qutenza and the skin washed and dried thoroughly.
Slovenian: Topikalne anestetike je treba pred uporabo zdravila Qutenza odstraniti, kožo oprati ter posušiti.
English: To ensure Qutenza maintains contact to the treatment area, stretchable socks or rolled gauze may be used.
Slovenian: Stik zdravila Qutenza z zdravljenim predelom je mogoče izboljšati tudi z raztegljivimi nogavicami ali omotom gaze.
English: Qutenza should be used with caution if you are pregnant.
Slovenian: Če ste noseči, je pri uporabi zdravila Qutenza potrebna previdnost.
English: For patients with unstable or poorly controlled hypertension or a history of cardiovascular disease, the risk of adverse cardiovascular events due to the potential stress of the procedure should be considered prior to initiating Qutenza treatment.
Slovenian: Pri bolnikih z nestabilno ali slabo nadzorovano hipertenzijo ali kardiovaskularno boleznijo v anamnezi je treba pred začetkom zdravljenja z zdravilom Qutenza oceniti tveganje neželenih kardiovaskularnih dogodkov zaradi morebitnega stresa zaradi postopka.
English: • in patients with unstable or poorly controlled hypertension or cardiovascular disease: to evaluate, prior to initiating Qutenza treatment, the risk of adverse cardiovascular eventsdue to the potential stress of the procedure.
Slovenian: • pri bolnikih z nestabilnim ali slabo nadzorovanim krvnim tlakom ali kardiovaskularnimi obolenji: pred uporabo zdravila Qutenza oceniti tveganja neželenih kardiovaskularnih dogodkov zaradi morebitnega stresa zaradi postopka.
English: Qutenza should only be applied by your doctor or by a nurse under the supervision of your doctor.
Slovenian: Zdravilo Qutenza sme aplicirati le zdravnik ali medicinska sestra pod nadzorom zdravnika.
English: Gauze wraps or socks may be used to promote contact between patch and skin.
Slovenian: Za izboljšanje stika med obližem in kožo lahko uporabite omote gaze ali nogavice.
English: After the cleansing gel has been wiped off, the area should be gently washed with soap and water.
Slovenian: Po odstranitvi čistilnega gela je treba predel nežno umiti z milom in vodo.
English: Burns second degree, accidental exposure (including eye pain, eye and throat irritation and cough)
Slovenian: Neznana opekline druge stopnje, nenamerna izpostavljenost zdravilu (vključno bolečina v očesu, draženje oči in žrela ter kašelj)
English: In Table 1 below all adverse reactions, which occurred at an incidence greater than control and in more than one patient in controlled clinical trials in patients with postherpetic neuralgia (PHN), painful Human Imunodeficiency Virus - Associated Neuropathy (HIV-AN) and painful diabetic peripheral neuropathy, are listed by system organ class and frequency: very common (≥ 1/10), common (≥ 1/100
Slovenian: V preglednici 1 spodaj so glede na organski sistem in pogostost navedeni vsi neželeni učinki, ki so se pojavili z večjo pogostnostjo kot v kontrolni skupini in pri več kot enem bolniku v kontroliranih kliničnih preskušanjih bolnikov s postherpetično nevralgijo (PNH), bolečo nevropatijo, povezano z virusom humane imunske pomanjkljivosti (HIV-AN - Human Imunnodeficiency Virus - Associated
English: Each 280 cm 2 patch contains a total of 179 mg of capsaicin or
Slovenian: En obliž velikosti 280 cm 2 vsebuje skupno 179 mg kapsaicina oz.
English: The cleansing gel for Qutenza contains butylhydroxyanisole which may cause local skin reactions (e.g. contact dermatitis), or irritation of the eyes and mucous membranes.
Slovenian: Čistilni gel za zdravilo Qutenza vsebuje butilhidroksianizol, ki lahko povzroča lokalne kožne reakcije (npr. kontaktni dermatitis) ali draženje oči in sluznic.
English: • Wheals, prickling sensation, inflammation, increased or decreased skin sensation, skin reaction,
Slovenian: • izpuščaji, zbadanje, vnetje kože, povečana občutljivost, vnetje, kožne reakcije, draženje,
English: Qutenza is for use on your skin.
Slovenian: Zdravilo Qutenza je namenjeno uporabi na koži.
English: Each 280 cm 2 cutaneous patch contains a total of 179 mg of capsaicin or 640 micrograms of capsaicin per cm 2 of patch.
Slovenian: En dermalni obliž velikosti 280 cm 2 vsebuje skupno 179 mg kapsaicina oz. 640 mikrogramov kapsaicina na cm 2 obliža.
English: It may take between 1 to 3 weeks before you experience pain relief with Qutenza.
Slovenian: Do olajšanja bolečin z zdravilom Qutenza lahko traja od 1 do 3 tedne.
English: Overdose may be associated with severe application site reactions, e.g. application site pain, application site erythema, application site pruritus.
Slovenian: Preveliko odmerjanje lahko povzroči hude reakcije na mestu aplikacije, npr. bolečino na mestu aplikacije, eriteme na mestu aplikacije, pruritus na mestu aplikacije.
English: All patients with pre-existing sensory deficits should be clinically assessed for signs of sensory loss to prior to each application of Qutenza.
Slovenian: Pri bolnikih, ki že imajo senzorične izpade, je treba pred vsako namestitvijo zdravila Qutenza klinično oceniti znake poslabšanja senzorične prizadetosti.
English: • Periodic Safety update Reports
Slovenian: o Redno posodobljena poročila o varnosti zdravila (PSUR)
English: The Qutenza cutaneous patch should be applied by a physician or by a health care professional under the supervision of a physician.
Slovenian: Zdravilo Qutenza mora aplicirati zdravnik ali zdravstveni delavec pod nadzorom zdravnika.
English: • If you get any side effects talk to your doctor.
Slovenian: • Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
English: Before placing the Qutenza patches on the skin, the treatment area(s) will be washed with soap and water and dried.
Slovenian: Pred aplikacijo obližev Qutenza na kožo je treba zdravljene predele umiti z milom in vodo ter osušiti.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja Občasni pruritus
English: Removable protective layer (release liner) polyester film, fluoropolymer coated
Slovenian: Odstranljiva zaščitna plast (zaščitna podloga) prevleka iz poliestra s plastjo fluoropolimera
English: Cut patch to match treatment area size.
Slovenian: Obliž odrežite tako, da ustreza velikosti zdravljenega predela.
English: Contains macrogol 300, carbomer, purified water, sodium hydroxide (E524), disodium edetate and butylhydroxyanisole (E320); See package leaflet for further information.
Slovenian: Vsebuje makrogol 300, karbomer, prečiščeno vodo, natrijev hidroksid (E524), dinatrijev edetat in butilhidroksianizol (E320).
English: Common: may affect up to 1 in 10 people
Slovenian: Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov
English: Although neither statistically significant nor dose dependent, the Fertility Index and the number of pregnancies per number of rats in cohabitation were reduced in all capsaicin-treated groups.
Slovenian: Indeks plodnosti in število brejih samic na število podgan, ki so bivale v kohabitaciji, sta se zmanjšala pri vseh skupinah, zdravljenih s kapsaicinom, vendar nista ne statistično značilna ne odvisna od odmerka.
English: What Qutenza contains
Slovenian: Kaj vsebuje zdravilo Qutenza
English: Qutenza is a cutaneous patch for use on your skin.
Slovenian: Zdravilo Qutenza je dermalni obliž za uporabo na koži.
English: See the package leaflet for further information.
Slovenian: Za dodatne informacije glejte navodilo za uporabo!
English: Increase in blood pressure
Slovenian: Preiskave Občasni zvišan krvni tlak
English: Grünenthal GmbH Zieglerstraße 6
Slovenian: Zieglerstraße 6
English: Each Qutenza carton contains 1 or 2 sachets and 1 tube of cleansing gel (50 g).
Slovenian: Ena škatla zdravila Qutenza vsebuje 1 ali 2 vrečki in 1 tubo čistilnega gela (50 g).
English: macrogol 300 carbomer purified water sodium hydroxide (E524) disodium edetate butylhydroxyanisole (E320)
Slovenian: makrogol 300 karbomer prečiščeno vodo natrijev hidroksid (E524) dinatrijev edetat butilhidroksianizol (E320)
English: Cutaneous use.
Slovenian: Za dermalno uporabo.
English: 1 sachet containing 1 cutaneous patch and 1 tube of cleansing gel (50 g).
Slovenian: 1 vrečka z 1 dermalnim obližem in 1 tubo čistilnega gela (50 g).
English: Cleansing gel macrogol 300 carbomer purified water sodium hydroxide (E524) disodium edetate butylhydroxyanisole (E320)
Slovenian: Čistilni gel makrogol 300 karbomer prečiščena voda natrijev hidroksid (E524) dinatrijev edetat butilhidroksianizol (E320)
English: Application site pain, application site erythema
Slovenian: Zelo pogosti bolečina na mestu aplikacije, eritemi na mestu aplikacije
English: Store flat in the original sachet and carton.
Slovenian: Shranjujte v vodoravnem položaju v originalni vrečki in škatli.
English: Very common: may affect more than 1 in 10 people • Redness or pain on the area where the patch is applied which lasts for more than a day.
Slovenian: • rdečina ali bolečina na mestu aplikacije obliža, ki traja dlje kot en dan Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov
English: The treatment area(s) should be gently washed with soap and water.
Slovenian: Zdravljene predele je treba nežno umiti z milom in vodo.
English: 2 sachets, each containing 1 cutaneous patch and 1 tube of cleansing gel (50 g).
Slovenian: 2 vrečki z 1 dermalnim obližem in 1 tubo čistilnega gela (50 g).
English: You should discontinue breastfeeding before treatment with Qutenza is started.
Slovenian: Pred začetkom zdravljenja z zdravilom Qutenza morate prenehati dojiti.
English: Renal and/or hepatic impairment
Slovenian: Bolniki z okvaro ledvic in/ali jeter
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
Slovenian: PODATKI, KI MORAJO BITI NAVEDENI NA PRIMARNI OVOJNINI
English: Use of a mask and protective glasses is recommended when applying and removing the patch, and applying cleansing gel afterwards.
Slovenian: Med namestitvijo in odstranjevanjem obliža ter med poznejšim nanašanjem čistilnega gela je priporočljiva uporaba maske in zaščitnih očal.
English: Application site pruritus, application site papules, application site vesicles, application site oedema, application site swelling, application site dryness
Slovenian: Pogosti pruritus na mestu aplikacije, papule na mestu aplikacije, vezikli na mestu aplikacije, edemi na mestu aplikacije, otekline na mestu aplikacije, suhost na mestu aplikacije
English: Place non-glossy side up while preparing.
Slovenian: Med pripravo obrnite nesijajno stran navzgor.
English: Remove patch release liner and apply to the skin.
Slovenian: Odstranite zaščitno podlogo obliža in obliž aplicirajte na kožo.
English: If Qutenza is used longer than it should
Slovenian: Če ste uporabljali zdravilo Qutenza, dlje kot je predpisano Preveliko odmerjanje je malo verjetno.
English: Outline treatment area.
Slovenian: Označite zdravljeni predel.
English: It is usual for the skin to sting or become red and burn during and after Qutenza treatment for a short while.
Slovenian: Običajno je, da se med uporabo zdravila Qutenza in po njej za nekaj časa pojavi zbadajoč ali pekoč občutek ali rdečina na koži.
English: The patch should be held in place.
Slovenian: Obliž je treba pričvrstiti.
English: Gently clean treated area with soap and water.
Slovenian: Zdravljeni predel nežno očistite z milom in vodo.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single-dose toxicity, and repeated-dose toxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri enkratnem odmerku in toksičnosti pri ponavljajočih se odmerkih, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: Nervous system disorders Common
Slovenian: Bolezni živčevja Pogosti pekoč občutek
English: How to store Qutenza
Slovenian: Shranjevanje zdravila Qutenza
English: Dysgeusia, hypoaesthesia
Slovenian: Žilne bolezni Občasni hipertenzija
English: • to undertake a visual examination of the feet prior to each application of Qutenza and at subsequent clinic visits to detect skin lesions related to underlying neuropathy and vascular insufficiency in patients with painful diabetic peripheral neuropathy
Slovenian: • pregledu stopal, ki ga je treba opraviti pri bolnikih z bolečo diabetično periferno nevropatijo pred zdravljenjem z zdravilom Qutenza in na poznejših pregledih, da bi ugotovili kožne spremembe, povezane z osnovno nevropatijo in žilno insuficienco
English: SACHET OF ONE PATCH
Slovenian: VREČKA Z ENIM OBLIŽEM
English: • to clinically assess patients for increased sensory loss prior to each application of Qutenza in all patients with pre-existing sensory deficits.
Slovenian: • klinični oceni bolnikov, ki že imajo senzorične izpade, glede znakov poslabšanja senzorične prizadetosti pred nadaljevanjem zdravljenja z zdravilom Qutenza
English: Dermal assessment
Slovenian: za dermalno uporabo
English: Disposable socks may be worn on top of the Qutenza patches if your feet are being treated.
Slovenian: Pri aplikaciji obližev Qutenza na stopalih si je mogoče prek obližev obuti nogavice za enkratno uporabo.
English: It is common for the skin to sting or become red and burn during Qutenza treatment.
Slovenian: Običajno se v koži med zdravljenjem z zdravilom Qutenza pojavi zbadajoč in pekoč občutek ali rdečina.
English: There is a diagonal cut in the release liner to aid in its removal.
Slovenian: Za lažje odstranjevanje je zaščitna podloga diagonalno prerezana.
English: A thorough history should be reviewed prior to initiating treatment and an alternative pain reduction strategy put in place prior to Qutenza treatment in patients with suspected high opioid tolerance.
Slovenian: Pri bolnikih, pri katerih obstaja sum na visoko toleranco na opioide, je treba pred pričetkom zdravljenja z zdravilom Qutenza pregledati celotno anamnezo in oblikovati alternativno strategijo za lajšanje bolečin.
English: Backing layer
Slovenian: dermalni obliž
English: The following information is intended for medical or healthcare professionals only: A complete Summary of Product Characteristics (SPC) is provided with this leaflet.
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju:
English: Nitrile gloves should be worn at all times while handling Qutenza and cleaning treatment areas.
Slovenian: Med rokovanjem z zdravilom Qutenza in čiščenjem zdravljenih predelov je treba ves čas nositi nitrilne rokavice.
English: Eye disorders Uncommon
Slovenian: Očesne bolezni Občasni draženje oči
English: Hypertension
Slovenian: Odmerjanje
English: itching, muscle spasms, shingles, swelling of limbs.
Slovenian: Občasni motnje okusa, hipestezija, pekoč občutek
English: STADA PHARMA Slovakia, s.r.o., Tel: +421 252621933
Slovenian: Tel: +421 252621933
English: Pain in extremity
Slovenian: Pogosti bolečine v okončini
English: Talk to your doctor before using Qutenza
Slovenian: Pred začetkom uporabe zdravila Qutenza se posvetujte z zdravnikom.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fycompa on 23 July 2012.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Fycompa, veljavno po vsej Evropski uniji, izdala 23. julija 2012.
English: Secondary generalisation occurs when the excessive electrical activity subsequently reaches the whole brain.
Slovenian: Do sekundarne generalizacije pride, ko prekomerna električna dejavnost postopoma zajame celotne možgane.
English: This is a type of epilepsy where too much electrical activity in one part of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness or a sudden sense of fear.
Slovenian: To je vrsta epilepsije, pri kateri prevelika električna dejavnost v enem delu možganov povzroči simptome, kot so nenadni sunkoviti gibi enega dela telesa, motnje sluha, voha ali vida, odrevenelost ali nenaden občutek strahu.
English: The full EPAR for Fycompa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Fycompa je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is available as tablets (2, 4, 6, 8, 10 and 12 mg) and as an oral suspension (0.5 mg/ml, to be taken by mouth).
Slovenian: Na voljo je v obliki tablet (2, 4, 6, 8, 10 in 12 mg) in kot peroralna suspenzija (0,5 mg/ml za peroralno uporabo).
English: Fycompa oral suspension can be taken with or without food and should always be taken in the same way (i.e. always with food or always without food).
Slovenian: Peroralna suspenzija Fycompa se lahko jemlje s hrano ali brez nje in jo je treba vedno jemati enako (tj. vedno s hrano ali vedno brez nje).
English: Fycompa tablets can be taken with or without food and should not be chewed, crushed or split.
Slovenian: Tablete Fycompa se lahko jemljejo s hrano ali brez nje in se ne smejo žvečiti, zdrobiti ali prelomiti.
English: What measures are being taken to ensure the safe and effective use of Fycompa?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Fycompa?
English: Neurotransmitters are naturally-occurring chemicals in the nervous system that allow nerve cells to communicate with each other.
Slovenian: Živčni prenašalci so naravno prisotne kemične snovi v živčnem sistemu, ki omogočajo medsebojno komunikacijo živčnih celic.
English: All patients were also taking other antiepileptic medicines.
Slovenian: Vsi bolniki so prejemali tudi druga zdravila proti epilepsiji.
English: This is a summary of the European public assessment report (EPAR) for Fycompa.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Fycompa.
English: Glutamate is the main stimulatory neurotransmitter in nerve cells which can trigger and maintain seizures.
Slovenian: Glutamat je glavni spodbujevalni živčni prenašalec v živčnih celicah, ki lahko sproži in vzdržuje napade.
English: For more information about treatment with Fycompa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Fycompa preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fycompa have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Fycompa upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.