FrancophonIA/ELRC3.0 huggingface dataset:
English: Gastrointestinal perforation, oesophagitis, gastrointestinal infection, ileus, gastrointestinal obstruction, ascites, lip oedema, oesophageal spasm, gastric ulcer, gastroesophageal reflux disease, reflux gastritis, retroperitoneal fibrosis, gastrointestinal disorder, anal haemorrhage, haemorrhoids, salivary hypersecretion, retching, salivary gland disorder, cheilitis, aerophagia, eructation, glossodynia, oral pain, teeth brittle
Slovenian: Bolezni prebavil driska, bruhanje, navzea, zaprtost gastrointestinalna krvavitev, stomatitis, gastrointestinalno vnetje, flatulenca, bolečine v trebuhu, disfagija, neprijeten občutek v trebuhu, dispepsija, suha usta gastrointestinalna perforacija, ezofagitis, gastrointestinalna okužba, ileus, gastrointestinalna obstrukcija, ascites, edem ustnic, ezofagealni spazem, želodčna razjeda, gastroezofagealna refluksna bolezen, refluksni gastritis, retroperitonealna fibroza, prebavne motnje, analna krvavitev, hemoroidi, povečano izločanje sline, draženje na bruhanje, delovanja žlez slinavk, heilitis, aerofagija, spahovanje, glosodinija, bolečina v ustih, motnje krhkost zob akutni pankreatitis
English: Refer to the cisplatin SmPC for eye disorders observed with cisplatin therapy.
Slovenian: Glede očesnih motenj, ki se pojavijo ob zdravljenju z cisplatinom, si oglejte povzetek glavnih značilnosti za cisplatin.
English: NAME OF THE MEDICINAL PRODUCT Teysuno 15 mg/4.35 mg/11.8 mg capsules tegafur/gimeracil/oteracil
Slovenian: Teysuno 15 mg/4,35 mg/11,8 mg kapsule tegafurum/gimeracilum/oteracilum
English: The capsule has an opaque white body and opaque brown cap imprinted “TC448” in grey.
Slovenian: Vsaka kapsula ima belo neprosojno telo z rjavim neprosojnim pokrovčkom in odtisom "TC448" v sivi barvi.
English: The capsule has an opaque white body and opaque white cap imprinted “TC442” in grey.
Slovenian: Vsaka kapsula ima belo neprosojno telo z belim neprosojnim pokrovčkom in odtisom "TC442" v sivi barvi.
English: Insomnia
Slovenian: Nevropatija
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 15 mg tegafur, 4.35 mg gimeracil and 11.8 mg oteracil (as salt).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena trda kapsula vsebuje 15 mg tegafurja, 4,35 mg gimeracila in 11,8 mg oteracila (v obliki soli).
English: either 42 capsules or 84 capsules.
Slovenian: Vsaka škatla vsebuje 42 kapsul ali 84 kapsul.
English: No data are available on the concomitant use of folinic acid with Teysuno in combination with cisplatin.
Slovenian: Podatki o sočasni uporabi folinske kisline in zdravila Teysuno v kombinaciji s cisplatinom niso na voljo.
English: Treatment-related bone marrow suppression, including neutropaenia, leukopaenia, thrombocytopaenia, anaemia, and pancytopaenia, has been reported among patients treated with Teysuno in combination with cisplatin.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Teysuno v kombinaciji s cisplatinom, so poročali o supresiji kostnega mozga, povezani z zdravljenjem, vključno z nevtropenijo, levkopenijo, trombocitopenijo, anemijo in pancitopenijo.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 20 mg tegafur, 5.8 mg gimeracil and 15.8 mg oteracil (as salt).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena trda kapsula vsebuje 20 mg tegafurja, 5,8 mg gimeracila in 15,8 mg oteracila (v obliki soli).
English: Hyperbilirubinaemia, alanine aminotransferase increased, aspartate aminotransferase increased
Slovenian: Bolezni jeter, žolčnika in žolčevodov hiperbilirubinemija, povečana alaninaminotransferaza, povečana aspartataminotransferaza nenormalne vrednosti testov jetrne funkcije, povečana gamaglutamiltransferaza akutna odpoved jeter
English: o To help manage nausea and vomiting: ▪ Lie down or take deep breaths when feeling nauseous ▪ Avoid tight clothing - Low red blood cell count leading to anaemia o You may have symptoms such as cold hands and feet, looking pale, light-headedness, fatigue, breathlessness.
Slovenian: - Majhno število rdečih krvnih celic, kar povzroči anemijo: o Lahko imate simptome, kot so hladne roke in noge, bledica, omotica, utrujenost in zasoplost.
English: Treatment should be discontinued if progressive disease or intolerable toxicity is observed.
Slovenian: Če se bolezen poslabša ali bolnik ne prenaša toksičnosti, je treba zdravljenje prekiniti.
English: Discontinue treatment
Slovenian: Namen zdraviti
English: asthenia
Slovenian: Zdravilo
English: - If you get any side effects, talk to your doctor.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetuje z zdravnikom.
English: Caution is advised as co-administration may increase the toxicity of Teysuno.
Slovenian: S sočasno uporabo se lahko poveča toksičnost zdravila Teysuno, zato se priporoča previdnost.
English: Muscle spasms, arthralgia, pain in extremity, back pain, neck pain, bone pain, joint swelling, limb discomfort, muscle tightness, muscular weakness
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva mišično-skeletna bolečina mišični spazmi, artralgija, bolečine v okončinah, bolečine v hrbtu, bolečine v vratu, bolečine v kosteh, otekanje sklepov, neprijeten občutek v okončinah, napetost mišic, mišična oslabelost rabdomioliza
English: No data are available on the concomitant use of methotrexate with Teysuno in combination with cisplatin.
Slovenian: Podatki o sočasni uporabi metotreksata in zdravila Teysuno v kombinaciji s cisplatinom niso na voljo.
English: Teysuno has not been studied in gastric cancer patients with MSI.
Slovenian: Pri bolnikih, ki imajo rak želodca in MSI, še niso izvedli nobenih študij za zdravilo Teysuno.
English: - Eye: itchy and red eyes, allergic reactions in eyes, drooping upper eyelid - Ear: vertigo, ear clogging, ear discomfort
Slovenian: Ušesne bolezni, vključno z motnjami labirinta slušna okvara, gluhost vertigo, zamašitev ušesa, neprijeten občutek v ušesu
English: Refer to the cisplatin SmPC for the effects of cisplatin on fertility, pregnancy and lactation.
Slovenian: Glede vpliva cisplatina na plodnost, nosečnost in dojenje si oglejte povzetek glavnih značilnosti za cisplatin.
English: NAME OF THE MEDICINAL PRODUCT Teysuno 20 mg/5.8 mg/15.8 mg capsules tegafur/gimeracil/oteracil
Slovenian: Teysuno 20 mg/5,8 mg/15,8 mg kapsule tegafurum/gimeracilum/oteracilum
English: - Liver: yellow eyes and skin, changes in blood tests which show the way the liver is working,
Slovenian: - Psihološki učinki: vidno in slušno zaznavanje stvari, ki ne obstajajo, osebnostne spremembe,
English: No data are available on the concomitant use of clozapine with Teysuno in combination with cisplatin.
Slovenian: Podatki o sočasni uporabi klozapina in zdravila Teysuno v kombinaciji s cisplatinom niso na voljo.
English: No data are available on the concomitant use of cimetidine with Teysuno in combination with cisplatin.
Slovenian: Podatki o sočasni uporabi cimetidina in zdravila Teysuno v kombinaciji s cisplatinom niso na voljo.
English: Nitroimidazoles, including metronidazole and misonidazole
Slovenian: Nitroimidazoli, vključno z metronidazolom in mizonidazolom Podatki o sočasni uporabi nitroimidazolov in zdravila Teysuno v kombinaciji s cisplatinom niso na voljo.
English: - Nerve: headache, dizziness, sleeplessness, changes in taste - Eye: eye problems, increased or decreased tearing discomfort, vision problems, serious illness with blistering of the eyes, wearing away of the surface “skin” of the eye (corneal erosion) - Ear: hearing problems - Blood vessels: high or low blood pressure, blood clots in the leg and lung
Slovenian: - Živci: glavobol, omotica, nespečnost, spremembe okusa - Oči: očesne težave, neprijeten občutek pri močnejšem ali šibkejšem solzenju, težave z vidom, huda bolezen z mehurčki na očeh, izjedanje površinske plasti očesa (erozija roženice) - Ušesa: slušne težave - Krvne žile: visok ali nizek krvni tlak, krvni strdki na nogah in v pljučih - Pljučne in nosne poti: kratka sapa, kašelj - Črevesje in usta: suha usta, vnetje ustne sluznice, žrela in požiralnika, kolcanje, bolečine v trebuhu, prebavne težave, vnetje želodca ali črevesja, perforacija želodca, tankega črevesa in debelega črevesa - Jetra: rumeno obarvanje očesnih beločnic in kože, spremembe v vrednosti krvnih testov, ki kažejo delovanje jeter - Koža: izguba las, srbenje, izpuščaj (ali dermatitis, kožna reakcija), suha koža, reakcije na rokah in nogah (bolečina, otekanje in pordelost rok in/ali nog), pigmentne lise na koži - Ledvica: zmanjšana količina urina, spremembe v vrednosti krvnih testov, ki kažejo delovanje ledvic, ter ledvična okvara in odpoved - Drugo: mrzlica, zmanjšanje telesne mase, otekanje na določenih mestih ter bolečine v mišicah in kosteh
English: In a dose escalation study comparing the tolerability of 5_FU in Teysuno and tegafur + gimeracil (no oteracil), the 25 mg/m2 dose level could not be attained in the absence of oteracil due to the occurrence of dose limiting toxicities (Grade 3 diarrhoea in 2 patients, and cardio-respiratory arrest in 1 patient) in the tegafur+gimeracil arm.
Slovenian: brez oteracila zaradi pojava toksičnih učinkov, ki omejujejo odmerek (driska stopnje 3 pri dveh bolnikih in kardiorespiratorni zastoj pri enem bolniku), pri kombinaciji tegafur + gimeracil.
English: b incl corneal epithelium defect, corneal erosion, corneal lesion, corneal opacity, corneal perforation, keratitis, punctate keratitis, ulcerative keratitis, limbal stem cell deficiency, visual acuity reduced, visual impairment, vision blurred.
Slovenian: keratitisom, keratitis punctata, ulcerativim keratitisom, pomanjkanjem limbalnih matičnih celic, zmanjšano ostrino vida, okvaro vida, zamegljenim vidom.
English: Peripheral neuropathy
Slovenian: Nehematološka merila
English: Hepatobiliary disorders
Slovenian: Hematološka merila
English: It does not matter which nostril you use.
Slovenian: Ni pomembno, katero nosnico uporabite.
English: This instrument is labelled in accordance with the EU Waste Electrical and Electronic Equipment Directive (WEEE).
Slovenian: Ta naprava je označena v skladu z Direktivo EU o odpadni električni in elektronski opremi (OEEO).
English: The batteries cannot be replaced.
Slovenian: Baterij ni mogoče zamenjati.
English: Instanyl with food, drink and alcohol
Slovenian: Instanyl skupaj s hrano, pijačo in alkoholom
English: Not known (frequency cannot be estimated from the available data):
Slovenian: Neznano (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
English: The primary therapeutic action is analgesia.
Slovenian: Primarno terapevtsko delovanje je analgezija.
English: The corresponding median Tmax are 12-15 minutes.
Slovenian: Ustrezne mediane vrednosti Tmax znašajo 12-15 minut.
English: This is because it may then give you the wrong dose.
Slovenian: To pa zato, ker lahko nato razprši napačen odmerek.
English: Teratogenic effects have not been demonstrated.
Slovenian: Teratogenih učinkov niso ugotovili.
English: Bend your head slightly forward.
Slovenian: Nagnite glavo nekoliko naprej.
English: These side effects can be very serious.
Slovenian: Ti neželeni učinki so lahko zelo resni.
English: Adequate body temperature and fluid intake should be maintained.
Slovenian: Treba je vzdrževati ustrezno telesno temperaturo in vnos tekočin.
English: Convulsions, loss of consciousness
Slovenian: Konvulzije, izguba zavesti
English: This may reduce the efficacy of Instanyl.
Slovenian: To lahko zmanjša učinkovitost zdravila Instanyl.
English: Do not test before use.
Slovenian: Ne preskušajte pred uporabo.
English: Your doctor will tell you whether Instanyl is suitable for you.
Slovenian: Zdravnik vam bo povedal, ali je zdravilo Instanyl za vas primerno.
English: The battery life is about to run out.
Slovenian: Življenjska doba baterije se bo kmalu iztekla.
English: Each black mark equals 10 minutes; the maximum locking period is 2 hours.
Slovenian: Vsaka črna oznaka pomeni 10 minut; najdaljše obdobje zaklepanja je 2 uri.
English: The clinical studies demonstrated the efficacy and safety of Instanyl.
Slovenian: Klinični študiji sta pokazali učinkovitost in varnost zdravila Instanyl.
English: You should sit or stand in upright position.
Slovenian: Stojte ali sedite v pokončnem položaju.
English: Available in the following presentations:
Slovenian: Na razpolago v naslednjih oblikah pakiranja:
English: Patients must be carefully monitored during the titration process.
Slovenian: Bolnike je treba v obdobju titracije skrbno nadzorovati.
English: The nasal spray has not been used for 7 days or more.
Slovenian: Pršilo za nos ni bilo uporabljeno 7 dni ali več.
English: This is indicated by a ‘P' in the display.
Slovenian: To je označeno z oznako »P« na zaslonu.
English: The absolute bioavailability of Instanyl is approximately 89.
Slovenian: Absolutna biološka uporabnost zdravila Instanyl znaša približno 89%.
English: Elderly and Cachectic population
Slovenian: Starejša in kahektična populacija
English: Start at 50 micrograms
Slovenian: Začnite s 50 mikrogrami.
English: Coadministration with medicinal products that induce 3A4 activity may reduce the efficacy of Instanyl.
Slovenian: Sočasna uporaba z zdravili, ki inducirajo aktivnost 3A4, lahko zmanjša učinkovitost zdravila Instanyl.
English: Each titration step (dose strength) should be evaluated in several episodes.
Slovenian: Vsako stopnjo titracije (jakost odmerka) je treba ovrednotiti v več epizodah.
English: Do not open the blister before you are ready to use the spray.
Slovenian: Ne odpirajte pretisnega omota, dokler niste pripravljeni za uporabo pršila.
English: If you have not been using these medicines you must not use Instanyl, because it may increase the risk that breathing could become dangerously slow and/or shallow, or even stop.
Slovenian: Če niste uporabljali teh zdravil, ne smete uporabljati zdravila Instanyl, saj lahko poviša tveganje, da postane dihanje nevarno počasno in/ali plitko ali se celo ustavi.
English: Instanyl can be harmful to other people, especially children.
Slovenian: Zdravilo Instanyl lahko škoduje drugim ljudem, predvsem otrokom.
English: What Instanyl is and what it is used for
Slovenian: Kaj je zdravilo Instanyl in za kaj ga uporabljamo
English: More recent studies showed that effects on the embryo were due to maternal toxicity and not to direct effects of the substances on the developing embryo.
Slovenian: Novejše študije kažejo, da so učinki na zarodek posledica toksičnosti za mater in ne nastanejo zaradi neposrednega učinkovanja snovi na razvijajoč se zarodek.
English: Patients undergoing treatment with Instanyl should be advised not to drive or operate machinery.
Slovenian: Bolnikom, ki se zdravijo z zdravilom Instanyl, je treba svetovati, naj ne vozijo ali upravljajo strojev.
English: The half-life of the antagonist may be short, therefore repeated administration or continuous infusion may be necessary.
Slovenian: Razpolovni čas antagonista je lahko kratek, zato utegne biti potrebna ponovitev vnosa ali trajna infuzija.
English: Children and adolescents Instanyl should not be used in children and adolescents under 18 years of age.
Slovenian: Zdravila Instanyl se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
English: The major metabolite, norfentanyl is inactive.
Slovenian: Glavni presnovek, norfentanil, je neaktiven.
English: Therefore, the use of any of these medicinal products concomitantly with Instanyl requires special patient care and observation.
Slovenian: Zato je pri uporabi katerega koli od teh zdravil sočasno z zdravilom Instanyl potrebna posebna oskrba bolnika in opazovanje.
English: If the display shows a battery symbol, this means that the battery life is about to run out.
Slovenian: Če se na zaslonu prikaže simbol baterije, to pomeni, da se bo življenjska doba baterije kmalu iztekla.
English: The lock symbol appears in the display together with a countdown-clock symbol, which shows the remaining time left of the locking period (each black mark equals 10 minutes).
Slovenian: Simbol ključavnice se na zaslonu prikaže skupaj s simbolom odštevalne ure, ki prikazuje preostali čas do odklepa pršila (vsaka črna oznaka pomeni10 minut).
English: Instanyl that has passed the expiry date or is no longer required, may still contain enough medicine to be harmful to other people, especially children.
Slovenian: Zdravilo Instanyl, ki mu je pretekel rok uporabnosti ali ga ne potrebujete več, lahko še vedno vsebuje dovolj zdravila, da škoduje drugim ljudem, predvsem otrokom.
English: - if you have ever developed adrenal insufficiency or lack of sex hormones (androgen deficiency) with opioid use.
Slovenian: - če ste kadar koli imeli adrenalno insuficienco ali pomanjkanje spolnih hormonov (pomanjkanje androgenov) ob uporabi opioidov.
English: Your single-dose container is now empty
Slovenian: Enoodmerni vsebnik je sedaj prazen.
English: • The prescribers of Instanyl nasal spray must critically select the patients, carefully monitor them throughout the whole treatment and counsel them on:
Slovenian: • Predpisovalci Instanyl pršila za nos morajo kritično izbirati bolnike, jih ves čas zdravljenja skrbno nadzirati in jim svetovati o:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 July 2009
Slovenian: Datum prve odobritve: 20. julij 2009 Datum zadnjega podaljšanja: 1. julij 2019
English: Patients receiving Instanyl concomitantly with moderate or strong CYP3A4 inhibitors should be carefully monitored for an extended period of time.
Slovenian: Bolnike, ki prejemajo zdravilo Instanyl sočasno z zmernimi ali močnimi zaviralci CYP3A4, je treba skrbno nadzorovati daljše časovno obdobje.
English: The nasal spray is locked and cannot be used.
Slovenian: Pršilo za nos je zaklenjeno in ni ga mogoče uporabiti.
English: Consider next higher strength for next episode
Slovenian: Za naslednjo epizodo razmislite o naslednji višji jakosti.
English: For management of respiratory depression immediate countermeasures should be started including physical or verbal stimulation of the patient.
Slovenian: V okviru zdravljenja depresije dihanja je treba takoj uvesti terapevtske protiukrepe, vključno s fizičnim ali verbalnim spodbujanjem bolnika.
English: • The pharmacist must make use of the checklist for pharmacist.
Slovenian: • Farmacevt mora uporabiti kontrolni seznam za farmacevte.
English: - if you take antidepressants or antipsychotics, please refer to the section ‘Other medicines and Instanyl'.
Slovenian: - če jemljete antidepresive ali antipsihotike, glejte poglavje »Druga zdravila in zdravilo Instanyl«.
English: Patients without maintenance opioid therapy as there is an increased risk of respiratory depression.
Slovenian: Bolniki brez vzdrževalne opioidne terapije, saj obstaja povišano tveganje respiratorne depresije.
English: Instanyl should not be used during pregnancy unless you have discussed this with your doctor.
Slovenian: Zdravila Instanyl ne smete uporabljati med nosečnostjo, razen če ste se o tem posvetovali z zdravnikom.
English: Effects on somatic development and behaviour of the offspring were not observed.
Slovenian: Učinkov na telesni razvoj in vedenje mladičev niso opazili.
English: Reversal of the narcotic effect may result in acute onset of pain and release of catecholamines.
Slovenian: Izničenje narkotičnega učinka lahko povzroči akuten pojav bolečine in sproščanje kateholaminov.
English: You may not feel the dose in your nose, but you have received it when you have pressed the pump.
Slovenian: Morda ne boste občutili odmerka v vašem nosu, vendar ste ga prejeli ob pritisku na bat.
English: What Instanyl is and what it is used for What you need to know before you use Instanyl How to use Instanyl
Slovenian: Kaj je zdravilo Instanyl in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Instanyl Kako uporabljati zdravilo Instanyl
English: Instanyl in doses above 400 micrograms have not been evaluated in clinical trials.
Slovenian: Zdravilo Instanyl v odmerkih nad 400 mikrogramov ni bilo ovrednoteno v kliničnih preskušanjih.
English: Opioids may cause hypotension, especially in patients with hypovolaemia.
Slovenian: Opioidi lahko povzročijo hipotenzijo, še posebej pri bolnikih s hipovolemijo.
English: Symptoms of overdose are:
Slovenian: Znaki prevelikega odmerjanja so:
English: If you experience difficulties breathing while being treated with Instanyl, it is very important that you contact your doctor or hospital immediately.
Slovenian: Če se med zdravljenjem z zdravilom Instanyl pojavijo težave z dihanjem, je zelo pomembno, da takoj pokličete svojega zdravnika ali bolnišnico.
English: If the breakthrough pain has stopped, do not take Instanyl until the next episode of breakthrough pain occurs.
Slovenian: Če je prebijajoča bolečina prenehala, ne uporabljajte zdravila Instanyl, dokler se ne pojavi naslednja epizoda prebijajoče bolečine.
English: BATTERY symbol
Slovenian: Simbol BATERIJE
English: The battery cannot be replaced and you need to get a new nasal spray.
Slovenian: Baterije ni mogoče zamenjati in dobiti morate novo pršilo za nos.
English: The following categories are used to rank the undesirable effects by frequency of occurrence: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); and very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: Za razvrstitev pogostnosti pojavljanja neželenih učinkov se uporabljajo naslednje kategorije: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Other medicines and Instanyl
Slovenian: Druga zdravila in zdravilo Instanyl
English: - medicines called Monoamine Oxidase Inhibitors (MAOI) used for severe depression, even if you have been treated with one in the past 2 weeks.
Slovenian: zdravila, imenovana zaviralci monoaminooksidaze (MAOI), ki se uporabljajo pri hudih oblikah depresije, tudi če ste se zdravili s tem zdravilom v zadnjih 2 tednih.
English: • diltiazem and verapamil (medicines for treatment of high blood pressure or heart diseases).
Slovenian: • diltiazem in verapamil (zdravili za zdravljenje visokega krvnega tlaka ali bolezni srca).
English: Method of titration
Slovenian: Metoda titracije
English: Pharmacotherapeutic group: Analgesics, opioids, ATC code: N02AB03
Slovenian: Farmakoterapevtska skupina: analgetiki, opioidi; oznaka ATC: N02AB03 Mehanizem delovanja
English: • The prescribing physician must ensure that the patient understands how to use Instanyl correctly, according to the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) and ensure that patients and carers are aware of the risks associated with Instanyl, including risks of overdose, misuse, drug dependence and abuse.
Slovenian: • Zdravnik, ki predpiše zdravilo, mora zagotoviti, da bolnik razume kako pravilno uporabljati zdravilo Instanyl v skladu s povzetkom glavnih značilnosti zdravila (SmPC) in navodilom za uporabo (PIL) in poskrbeti, da se bolniki in negovalci zavedajo tveganj, povezanih z uporabo zdravila Instanyl, vključno s tveganji prevelikega odmerjanja, napačne uporabe, razvoja odvisnosti od zdravila in zlorabe.
English: Prior to launch of the multi-dose and single-dose product in each Member State the MAH shall agree the final educational material with the National Competent Authority.
Slovenian: Pred uvajanjem večodmernega in enoodmernega zdravila na tržišče vsake države članice se imetnik dovoljenja za promet z zdravilom dogovori o končnem izobraževalnem gradivu s pristojnim organom države članice.
English: Fentanyl use may be associated with bradycardia.
Slovenian: Uporaba fentanila je lahko povezana z bradikardijo.
English: Adequate pain relief with one dose of Instanyl
Slovenian: Zadostno olajšanje bolečine z enim odmerkom zdravila Instanyl
English: - The risk of side effects increases if you are taking medicines such as certain antidepressants or antipsychotics.
Slovenian: - tveganje neželenih učinkov se poveča, če jemljete zdravila, kot so nekateri antidepresivi ali antipsihotiki.
English: Furthermore, studies in female rats revealed reduced fertility and enhanced embryonal mortality.
Slovenian: Poleg tega so preskušanja pri podganjih samicah pokazala zmanjšano plodnost in večjo umrljivost zarodkov.