FrancophonIA/ELRC3.0 huggingface dataset:
English: Tel: +39 (0)2 241 26710/26711 info@nordicpharma.it
Croatian: Nordic Pharma Tel: +39 (0)2 753 2629 info@nordicpharma.it
English: Erectile dysfunction, breast tenderness, nipple pain
Croatian: Poremećaji reproduktivnog sustava i dojki erektilna disfunkcija, osjetljivost dojki, bol u bradavicama
English: Muscle spasms, arthralgia, pain in extremity, back pain, neck pain, bone pain, joint swelling, limb discomfort, muscle tightness, muscular weakness
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva mišićno-koštana bol spazmi mišića, artralgija, bol u ekstremitetima, bol u leđima, bol u vratu, bol u kostima, oticanje zglobova, nelagoda u udovima, mišićna napetost, mišićna slabost rabdomioliza
English: Pancytopenia, prothrombin time prolonged, international normalised ratio increased, hypoprothrombinaemia, prothrombin time shortened, granulocytosis, leukocytosis, eosinophilia, lymphocytosis, monocyte count decreased, monocyte count increased, thrombocythaemia
Croatian: Poremećaji krvi i limfnog sustava neutropenija, leukopenija, anemija, trombocitopenija febrilna neutropenija, limfopenija pancitopenija, produljeno protrombinsko vrijeme, povećan INR, hipoprotrombinemija, skraćeno protrombinsko vrijeme, granulocitoza, leukocitoza, eozinofilija, limfocitoza, smanjen broj monocita, povećan broj monocita, trombocitemija diseminirana intravaskularna koagulacija
English: No data are available on the concomitant use of methotrexate with Teysuno in combination with cisplatin.
Croatian: Nema dostupnih podataka o istodobnoj primjeni metotreksata s lijekom Teysuno u kombinaciji s cisplatinom.
English: Hypotension, deep vein thrombosis, hypertension
Croatian: hematomi, hiperemija, navale vrućine
English: Platelets Haemoglobin Teysuno dose modification
Croatian: Prilagodba doze lijeka Teysuno
English: o If you experience any of the above-mentioned symptoms, try not to work too hard and get ample sleep and rest. - Low white blood cell count leading to increased risk of severe local (e.g.,oral, lung, urine) or blood infections o You may have symptoms such as fever, chills, coughing, sore throat.
Croatian: - Smanjenje broja bijelih krvnih stanica što dovodi do povećanog rizika od teških lokalnih infekcija (tj. usne šupljine, pluća,mokraće) ili infekcija krvi ᴑ Možete imati smptome kao što je vrućica, zimica, kašljanje, grlobolja.
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.
Croatian: Uslijed liječenja lijekom Teysuno u kombinaciji s cisplatinom, u bolesnika je uočena supresija koštane srži, uključujući neutropeniju, leukopeniju, trombocitopeniju, anemiju i pancitopeniju.
English: Contents of the pack and other information What Teysuno contains - The active substances are tegafur, gimeracil and oteracil.
Croatian: Teysuno sadrži djelatne tvari tegafur, gimeracil i oteracil.
English: Mucosal inflammation, pyrexia, weight decreased, peripheral oedema, chills
Croatian: Opći poremećaji i reakcije na mjestu primjene umor, astenija upala sluznice, pireksija, gubitak na težini, periferni edem, zimica,
English: : +33 (0)1 70 37 28 00 info@nordicpharma.com
Croatian: Tel/Τηλ/Tél/Tel.: +33 (0)1 70 37 28 00 info@nordicpharma.com
English: Table 2: Standard and reduced dose calculations by body surface area (m2)
Croatian: → 15a i/ili cisplatin a izraženo kao sadržaj tegafura Izračun doze lijeka Teysuno Tablica 2: Standardna i smanjena doza izračunata prema površini tijela (m2) Doza lijeka Teysuno Svaka doza u mg (svako doziranje)a
English: Vertigo, ear congestion, ear discomfort
Croatian: Poremećaji uha i labirinta poremećaj sluha, gluhoća vrtoglavica, začepljenost uha, nelagoda u uhu
English: NAME OF THE MEDICINAL PRODUCT Teysuno 20 mg/5.8 mg/15.8 mg capsules tegafur/gimeracil/oteracil
Croatian: Teysuno 20 mg/5,8 mg/15,8 mg kapsule tegafur/gimeracil/oteracil
English: No data are available on the concomitant use of clozapine with Teysuno in combination with cisplatin.
Croatian: Nema dostupnih podataka o istodobnoj primjeni klozapina s lijekom Teysuno u kombinaciji s cisplatinom.
English: Hyperbilirubin-aem ia, alanine aminotransferase increased, aspartate aminotransferase increased
Croatian: Hepatobilijarni poremećaji hiperbilirubinemija, povećanje alaninaminotransfera ze, povećanje aspartataminotransfer aze abnormalni testovi funkcije jetre, povećanje gamaglutamiltransferaze akutno zatajenje jetre
English: (pain, swelling and redness of hands and/or feet), pigmented skin patches - Kidney: decreased urine volume, changes in blood tests which show the way the kidney is working, kidney impairment and failure - Other: chills, weight decrease, swelling in specific areas and muscle bone pain
Croatian: upala želuca ili crijeva, perforacija želuca, tankog i debelog crijeva - Jetru: žutilo očiju i kože, promjene u nalazima krvi koji ukazuju na rad jetre - Kožu: gubitak kose, svrbež, osip ili dermatitis, kožna reakcija, suha koža, reakcija na dlanovima i tabanima (bol, oticanje i crvenilo dlanova i/ili tabana) pigmentirane mrlje po koži - Bubrege: smanjen volumen urina, promjene u nalazima krvi koji ukazuju na rad bubrega, oštećenje i zatajenje bubrega.
English: Acute hepatic failure
Croatian: Teško oštećenje bubrega
English: Very common side effects (may affect more than 1 in 10people) include:
Croatian: Manje česte nuspojave (mogu se javiti u više od 1 na 1000 osoba) uključuju:
English: cysts and polyps)
Croatian: (vodene kozice ili herpes zoster).
English: No data are available on the concomitant use of cimetidine with Teysuno in combination with cisplatin.
Croatian: Nema dostupnih podataka o istodobnoj primjeni cimetidina s lijekom Teysuno u kombinaciji s cisplatinom.
English: What Teysuno looks like and contents of the pack The hard capsules have a white body and opaque brown cap imprinted "TC448" in grey.
Croatian: Tvrde kapsule se sastoje od bijelog tijela i neprozirne smeđe kapice s oznakom „TC448“ u sivoj boji.
English: The corresponding median Tmax are 12-15 minutes.
Croatian: Odgovarajući medijan Tmax je 12-15 minuta.
English: This instrument is labelled in accordance with the EU Waste Electrical and Electronic Equipment Directive (WEEE).
Croatian: Ovaj uređaj označen je u skladu s Direktivom EU o električnom i elektroničkom otpadu (WEEE).
English: Instanyl with food, drink and alcohol
Croatian: Instanyl s hranom, pićem i alkoholom
English: The batteries cannot be replaced.
Croatian: Baterije se ne mogu zamijeniti.
English: This should clear any blockage.
Croatian: Time bi se trebala ukloniti svaka blokada.
English: This may reduce the efficacy of Instanyl.
Croatian: To može smanjiti djelotvornost Instanyla.
English: This is because it may then give you the wrong dose.
Croatian: Tada vam može dati krivu dozu.
English: Try to keep the person awake until emergency help arrives.
Croatian: Pokušajte održati osobu budnom do dolaska hitne pomoći.
English: The primary therapeutic action is analgesia.
Croatian: Glavno terapijsko djelovanje je analgezija.
English: Not known (frequency cannot be estimated from the available data):
Croatian: Nepoznato (učestalost se ne može procijeniti na temelju dostupnih podataka):
English: Please consider to contact the physician for discussion.
Croatian: Molimo razmislite o kontaktiranju liječnika radi diskusije.
English: Teratogenic effects have not been demonstrated.
Croatian: Teratogeno djelovanje nije dokazano.
English: What Instanyl is and what it is used for
Croatian: Što je Instanyl i za što se koristi
English: - Use one dose of Instanyl - Wait 10 minutes
Croatian: - Primijeniti jednu dozu Instanyla - Pričekati 10 minuta
English: • shows the number of doses left
Croatian: • prikazuje broj preostalih doza
English: Instanyl can be harmful to other people, especially children.
Croatian: Instanyl može naškoditi drugim ljudima, a naročito djeci.
English: Effects on somatic development and behaviour of the offspring were not observed.
Croatian: Učinci na somatski razvoj i ponašanje potomaka nije uočeno.
English: Date of latest renewal: 01 July 2019
Croatian: Datum posljednje obnove: 1. srpnja 2019.
English: Children and adolescents Instanyl should not be used in children and adolescents under 18 years of age.
Croatian: Djeca i adolescenti Instanyl ne smiju koristiti djeca i adolescenti u dobi do 18 godina.
English: These side effects can be very serious.
Croatian: Te nuspojave mogu postati vrlo ozbiljne.
English: Convulsions, loss of consciousness
Croatian: Konvulzije, gubitak svijesti
English: Each black mark equals 10 minutes; the maximum locking period is 2 hours.
Croatian: Svaka crna oznaka jednaka je razdoblju od 10 minuta; maksimalno vrijeme zaključavanja je 2 sata.
English: What Instanyl contains
Croatian: Što Instanyl sadrži
English: Contact your doctor to confirm the correct dose of your usual medicine if you are not sure.
Croatian: Kontaktirajte liječnika kako biste potvrdili ispravnu dozu uobičajene terapije ukoliko niste sigurni.
English: You should sit or stand in upright position.
Croatian: 2. Trebate sjesti ili stajati u uspravnom položaju.
English: Instanyl should not be used in pregnancy unless clearly necessary and if the benefits outweigh the risks.
Croatian: Instanyl se ne smije primjenjivati u trudnoći osim ako za time ne postoji jasna potreba i ako koristi nadmašuju rizike.
English: The nasal spray has not been used for 7 days or more.
Croatian: Sprej za nos nije se koristio 7 dana ili više.
English: Furthermore, studies in female rats revealed reduced fertility and enhanced embryonal mortality.
Croatian: Nadalje, ispitivanja na ženkama štakora pokazala su smanjenu plodnost i povećanu embrionalnu smrtnost.
English: Therefore, the use of any of these medicinal products concomitantly with Instanyl requires special patient care and observation.
Croatian: Prema tome, istovremeno korištenje bilo kojeg od ovih lijekova s lijekom Instanyl zahtijeva poseban oprez i nadzor.
English: • It must be pumped 3 or 4 times (primed) until a fine mist appears.
Croatian: • mora se potisnuti 3 ili 4 puta (priprema za primjenu) dok se ne pojavi fina maglica.
English: Other medicines and Instanyl
Croatian: Drugi lijekovi i Instanyl
English: The content is:
Croatian: Sadržaj je:
English: Ask your pharmacist.
Croatian: Upitajte svog ljekarnika za savjet.
English: The safety and efficacy of Instanyl in children aged below 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost Instanyla u djece u dobi do 18 godina nisu još ustanovljene.
English: What you need to know before you use Instanyl
Croatian: Što morate znati prije nego počnete primjenjivati Instanyl
English: • shows whether the nasal spray is locked or ready for use
Croatian: • prikazuje je li sprej za nos zaključan ili spreman za uporabu
English: Instanyl shows linear kinetics.
Croatian: Instanyl pokazuje linearnu kinetiku.
English: It does not matter which nostril you use.
Croatian: Nije bitno je o kojoj se nosnici radi.
English: The battery cannot be replaced and you need to get a new nasal spray.
Croatian: Baterija se ne može zamijeniti i morate nabaviti novi sprej za nos.
English: Fentanyl is highly lipophilic.
Croatian: Fentanil je visoko lipofilan.
English: Your doctor will evaluate if you need medicine to reduce or eliminate the withdrawal symptoms.
Croatian: Liječnik će ocijeniti je li Vam potreban lijek za smanjenje ili uklanjanje simptoma ustezanja.
English: The clinical studies demonstrated the efficacy and safety of Instanyl.
Croatian: Klinička ispitivanja pokazala su djelotvornost i sigurnost Instanyla.
English: Other side effects reported after use of Instanyl:
Croatian: Ostale nuspojave prijavljene nakon primjene Instanyla:
English: Coadministration with medicinal products that induce 3A4 activity may reduce the efficacy of Instanyl.
Croatian: Istovremena primjena lijekova koji induciraju 3A4 aktivnost može smanjiti djelotvornost Instanyla.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity,genotoxicity and carcinogenicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i kancerogenosti.
English: Each titration step (dose strength) should be evaluated in several episodes.
Croatian: Svaki korak u titraciji (jačinu doze) treba ocijeniti u nekoliko epizoda.
English: The nasal spray is locked and cannot be used.
Croatian: Sprej za nos je zaključan i ne može se koristiti.
English: The major metabolite, norfentanyl is inactive.
Croatian: Glavni metabolit norfentanil je inaktivan.
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.
Croatian: Instanyl kojem je istekao rok valjanosti ili koji više nije potreban i dalje može sadržavati dovoljno lijeka da naškodi drugim ljudima, a naročito djeci.
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).
Croatian: Simbol lokota javlja se na zaslonu zajedno sa simbolom odbrojavanja koji prikazuje preostalo vrijeme razdoblja zaključavanja (svaka crna oznaka jednaka je razdoblju od 10 minuta).
English: • The prescribers of Instanyl nasal spray must critically select the patients, carefully monitor them throughout the whole treatment and counsel them on:
Croatian: • Propisivači Instanyl spreja za nos moraju kritički odabrati bolesnike, pažljivo ih nadzirati tijekom čitavog liječenja i savjetovati ih o:
English: If serotonin syndrome is suspected, treatment with Instanyl should be discontinued.
Croatian: Ako se posumnja na pojavu serotoninskog sindroma treba prekinuti liječenje Instanylom.
English: Change in dose must be done together with your doctor.
Croatian: Promjenu doze mora se dogovoriti s liječnikom.
English: Fentanyl use may be associated with bradycardia.
Croatian: Primjena fentanila može biti povezana s bradikardijom.
English: Every time you use Instanyl nasal spray, make sure you or your carer fills in the information on the card.
Croatian: Svaki put kada upotrijebite Instanyl sprej za nos, pobrinite se da vi ili vaš skrbnik ispunite podatke na kartici.
English: What Instanyl is and what it is used for What you need to know before you use Instanyl How to use Instanyl
Croatian: Što je Instanyl i za što se koristi Što morate znati prije nego počnete primjenjivati Instanyl Kako primjenjivati Instanyl
English: If the display shows a battery symbol, this means that the battery life is about to run out.
Croatian: Ako zaslon prikazuje simbol baterije, to znači da će se baterija uskoro isprazniti.
English: Maximum daily dose: Treatment of up to four breakthrough pain episodes, each with no more than two doses separated by at least 10 minutes.
Croatian: Maksimalna dnevna doza: Liječenje do četiri epizode probojne boli, svaka s ne više od dvije doze razdvojene najmanje 10 minuta.
English: You must make sure the pump is pressed all the way down.
Croatian: Morate biti sigurni da je pumpica zaista pritisnuta do kraja.
English: This is indicated by a ‘P' in the display.
Croatian: To je naznačeno oznakom „P“ na zaslonu.
English: Elderly and Cachectic population
Croatian: Starija i kahektična populacija
English: Instanyl should not be used pre-emptively.
Croatian: Instanyl ne treba koristi preventivno.
English: The nasal spray container contains batteries.
Croatian: Sprej za nos sadrži baterije.
English: Pharmacotherapeutic group: Analgesics, opioids, ATC code: N02AB03
Croatian: Farmakoterapijska skupina: Analgetici, opioidi, ATK oznaka: N02AB03
English: Abuse potential and dependence
Croatian: Zloupotreba i ovisnost
English: The display counts downward after each pump (P5, P4, P3, P2 and P1).
Croatian: Zaslon prikazuje jedan broj manje nakon svakog potiska (P5, P4, P3, P2 i P1).
English: Do not press the plunger yet.
Croatian: Još ne pritišćite klip.
English: Your single-dose container is now empty
Croatian: Jednodozni spremnik je sada prazan.
English: Do not throw away Instanyl via wastewater or household waste.
Croatian: Nemojte bacati Instanyl u otpadne vode ili kućni otpad.
English: Patients in the second pivotal study had earlier participated in the Instanyl pharmacokinetic study or in the first pivotal study.
Croatian: Bolesnici uključeni u drugo pivotalno ispitivanje ranije su sudjelovali u farmakokinetskom ispitivanju Instanyla ili u prvom pivotalnom ispitivanju.
English: You should not start breast-feeding until at least 5 days after the last dose of Instanyl.
Croatian: Ne smijete početi dojiti prije nego što prođe najmanje 5 dana od uzimanja posljednje doze Instanyla.
English: Patients undergoing treatment with Instanyl should be advised not to drive or operate machinery.
Croatian: Bolesnicima koji se liječe Instanylom treba savjetovati da ne upravljaju vozilima i ne rade sa strojevima.
English: Dose increase should be done with caution.
Croatian: Dozu treba povećavati s oprezom.
English: If someone has accidentally taken Instanyl, they may have the same symptoms as described above for overdose.
Croatian: Ako netko slučajno uzme Instanyl mogu se pojaviti isti simptomi kao oni navedeni za predoziranje.
English: Patients receiving Instanyl concomitantly with moderate or strong CYP3A4 inhibitors should be carefully monitored for an extended period of time.
Croatian: Bolesnike koji primaju Instanyl istovremeno s umjerenim ili snažnim CYP3A4 inhibitorima treba pomno nadzirati tijekom duljeg razdoblja.
English: • If it is blocked, aim the nasal spray away from you (and any other people) and push firmly down on the pump.
Croatian: • Ako je blokiran, usmjerite sprej za nos dalje od sebe (i drugih ljudi) i čvrsto pritisnite pumpicu.
English: The pain-relieving medicine in Instanyl is very strong and can be life-threatening to children.
Croatian: Lijek za ublažavanje boli u Instanylu je vrlo snažan i može biti po život opasan za djecu.
English: Never try to fix the nasal spray yourself or take it apart.
Croatian: Nikada nemojte pokušavati sami popraviti ili rastaviti sprej za nos.
English: Instanyl in doses above 400 micrograms have not been evaluated in clinical trials.
Croatian: Doze Instanyla više od 400 mikrograma nisu ispitane u kliničkim ispitivanjima.
English: If the breakthrough pain is still ongoing, you may take Instanyl as prescribed by your doctor.
Croatian: Ako epizoda probojne boli i dalje traje, možete primijeniti Instanyl kako je preporučio liječnik.
English: Respiratory depression following an overdose may outlast the duration of action of the opioid antagonist.
Croatian: Respiratorna depresija nakon predoziranja može trajati dulje od djelovanja opioidnog antagonista.
English: BATTERY symbol
Croatian: Simbol BATERIJE
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor or pharmacist for advice before taking any medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek.
English: Opioids act by blocking the pain signals to the brain.
Croatian: Opioidi djeluju blokirajući bolne signale prema mozgu.
English: If you think you are becoming dependent on Instanyl, it is important that you inform you doctor.
Croatian: Ako smatrate da postajete ovisni o Instanylu, važno je da o tome obavijestite liječnika.
English: If the breakthrough pain has stopped, do not take Instanyl until the next episode of breakthrough pain occurs.
Croatian: Ako je probojna bol iščezla, ne primjenjujte Instanyl do pojave sljedeće epizode probojne boli.
English: Do not test before use.
Croatian: Ne testirajte prije primjene.
English: • Always to keep Instanyl out of the reach and sight of children since it can be harmful to them.
Croatian: • Da uvijek čuvaju Instanyl izvan dosega i pogleda djece jer im može naškoditi.
English: The single-dose container should not be tested before use.
Croatian: Jednodozni spremnik se ne smije testirati prije primjene.
English: The half-life of the antagonist may be short, therefore repeated administration or continuous infusion may be necessary.
Croatian: Zbog kratkog poluvijeka antagonista može biti potrebna ponavljana primjena ili kontinuirana infuzija.
English: The MAH shall ensure that, all physicians, pharmacists and patients expected to prescribe/dispense/use Instanyl are provided with educational material regarding the correct and safe use of the product.
Croatian: Nositelj odobrenja mora osigurati da svi liječnici, farmaceuti i bolesnici za koje se očekuje da će propisati/izdati/koristiti Instanyl dobiju edukacijski materijal o ispravoj i sigurnoj primjeni lijeka.
English: Shows how much time is left of the locking period.
Croatian: Pokazuje preostalo vrijeme razdoblja zaključavanja.
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.
Croatian: Novija ispitivanja pokazuju da su učinci na embrij posljedica toksičnog djelovanja na majku, a ne izravnog djelovanja tvari na embrij u razvoju.
English: Opioids may cause hypotension, especially in patients with hypovolaemia.
Croatian: Opioidi mogu izazvati hipotenziju, a naročito u bolesnika s hipovolemijom.
English: Do not change the dose of Instanyl or your other pain medicines on your own.
Croatian: Ne mijenjajte samovoljno dozu Instanyla ili drugih lijekova protiv boli.
English: Therefore:
Croatian: Stoga:
English: The display will now turn on and show ‘P5'.
Croatian: Zaslon će se sada uključiti i prikazati „P5“.
English: For management of respiratory depression immediate countermeasures should be started including physical or verbal stimulation of the patient.
Croatian: Za liječenje respiratorne depresije potrebno je odmah poduzeti protumjere koje uključuju fizičku i verbalnu stimulaciju bolesnika.
English: If Instanyl has been administered, an antidote for the child should be readily available.
Croatian: Ako je primijenjen Instanyl, nužno je odmah imati spreman antidot za dijete.
English: About 75 of fentanyl is excreted into the urine, mostly as inactive metabolites, with less than 10 as unchanged active substance.
Croatian: Oko 75% fentanila izlučuje se u mokraću, većinom u obliku inaktivnih metabolita, sa manje od 10% kao neizmjenjena djelatna tvar.
English: SPECIAL STORAGE CONDITIONS Store below 30C.
Croatian: POSEBNE MJERE ČUVANJA Čuvati na temperaturi ispod 30 °C.
English: The patients had an average of 1 to 4 episodes per day while taking maintenance opioid therapy.
Croatian: Bolesnici su u prosjeku imali 1 do 4 epizode probojne boli dnevno tijekom terapije održavanja opioidima.
English: This is the approximate number of doses that can be delivered from the nasal spray, before the battery is too low and the display turns off.
Croatian: To je približan broj doza koji se može isporučiti iz spreja za nos prije nego baterija postane preslaba, a zaslon se isključi.
English: Local tolerance studies with Instanyl in mini-pigs demonstrated that Instanyl administration was well tolerated.
Croatian: Ispitivanje lokalne podnošljivosti Instanyla na patuljastim svinjama pokazalo je da se primjena Instanyla dobro podnosi.
English: Symbols in the electronic display
Croatian: Simboli na elektroničkom zaslonu
English: If you stop using Instanyl
Croatian: Ako prestanete primjenjivati Instanyl
English: The nasal spray can only be used when the lock symbol is not visible in the display.
Croatian: Sprej za nos smije se koristiti samo kada simbol lokota nije vidljiv na zaslonu.
English: If you think someone has accidentally taken Instanyl, please seek immediate medical assistance.
Croatian: Mislite li da je netko zabunom primijenio Instanyl, molimo odmah potražite medicinsku pomoć.