FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant use of Instanyl with other medicinal products (other than oxymetazoline) administered via the nose has not been evaluated in the clinical trials.
Croatian: Istovremena primjena Instanyla s drugim lijekovima (osim oksimetazolina) koji se primjenjuju u nos nije ispitana u kliničkim ispitivanjima.
English: There have also been reports of patients developing a hole in the septum of the nose - the structure, which separates the nostrils.
Croatian: Prijavljeni su također slučajevi probijanja nosne pregrade - strukture koja razdvaja nosnice.
English: Reversal of the narcotic effect may result in acute onset of pain and release of catecholamines.
Croatian: Poništavanja narkotičkog djelovanja može za posljedicu imati pojavu akutne boli i oslobađanje katekolamina.
English: It is contained in a brown glass bottle with a metering pump.
Croatian: Sadržana je u smeđoj staklenoj bočici s odmjernom pumpicom.
English: If the battery symbol appears in the display, it is recommended that you contact your doctor to get a new nasal spray.
Croatian: Ako se na zaslonu prikaže simbol baterije, preporučuje se da se obratite svom liječniku kako biste dobili novi sprej za nos.
English: Caution is advised when Instanyl is coadministered with medicinal products that affect the serotoninergic neurotransmitter systems.
Croatian: Preporučuje se oprez kod istovremene primjene Instanyla i lijekova koji utječu na serotoninergički neurotransmitorski sustav.
English: • The pharmacist must make use of the checklist for pharmacist.
Croatian: • Ljekarnik mora koristiti kontrolnu listu za ljekarnike.
English: Previous facial radiotherapy.
Croatian: Ranija radioterapija lica.
English: The battery life is about to run out.
Croatian: Baterija će se uskoro isprazniti.
English: If you experience that the nasal spray does not work as described in the “Instructions for use” please contact your doctor or pharmacist.
Croatian: Ako primjetite da sprej za nos ne radi kako je opisano u „Uputama za primjenu“ obratite se svom liječniku ili ljekarniku.
English: The nasal spray must be pumped 5 times (primed), before it can be used (see section ‘Preparing the Instanyl nasal spray').
Croatian: Pumpa spreja za nos se mora potisnuti 5 puta (priprema spreja) prije nego što se sprej može koristiti (vidjeti dio „Priprema Instanyl spreja za nos“).
English: If you experience difficulties breathing while being treated with Instanyl, it is very important that you contact your doctor or hospital immediately.
Croatian: Ako za vrijeme liječenja Instanylom osjetite teškoće s disanjem, vrlo je važno da se odmah javite Vašem liječniku ili u bolnicu.
English: Adequate pain relief with one dose of Instanyl
Croatian: Primjereno ublažavanje boli s jednom dozom Instanyla
English: Dose linearity from 50 micrograms to 400 micrograms of Instanyl has been demonstrated in healthy subjects.
Croatian: Linearnost doze od 50 mikrograma do 400 mikrograma Instanyla pokazana je na zdravim ispitanicima.
English: • If your nasal spray is still not working properly, talk to your pharmacist.
Croatian: • Ako sprej za nos i dalje ne radi ispravno, obratite se svom ljekarniku.
English: You may not feel the dose in your nose, but you have received it when you have pressed the pump.
Croatian: Istisnutu dozu možda nećete osjetiti u nosu, ali primili ste je kad ste pritisnuli klip.
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.
Croatian: Prije stavljanja na tržište jednodoznog i višedoznog lijeka u svakoj državi članici nositelj odobrenja treba s nadležnim tijelom dogovoriti konačni edukacijski materijal.
English: Treatment of acute pain other than breakthrough pain.
Croatian: Liječenje druge akutne boli osim probojne boli.
English: If uncertain of how the pump has been stored, you should check the spray pump before use.
Croatian: Ako niste sigurni kako je bočica bila čuvana, prije primjene provjerite pumpicu.
English: In serious cases taking too much Instanyl may cause coma, sedation, convulsions or severe breathing difficulties (very slow or shallow breathing).
Croatian: U ozbiljnim slučajevima prekomjerno uzimanje Instanyla može izazvati komu, sedaciju, konvulzije ili izrazite teškoće s disanjem (vrlo usporeno ili plitko disanje).
English: Animal data shows that following absorption, fentanyl is rapidly distributed to the brain, heart, lungs, kidneys and spleen followed by a slower redistribution to muscles and fat.
Croatian: Podaci na životinjama pokazuju da se nakon apsorpcije fentanil brzo raspodjeljuje u mozak, srce, pluća, bubrege i slezenu, nakon čega slijedi sporija preraspodjela u mišiće i masno tkivo.
English: The number of doses in the display changes to 5.
Croatian: Broj doza na zaslonu mijenja se u „5“.
English: Repeat this procedure for ‘P2' and ‘P1' (press the white button and pump) until the display changes to show the number of doses in the nasal spray (i.e. 10, 20, 30 or 40 doses) and flashing lock symbol.
Croatian: Ponovite ovaj postupak za „P2“ i „P1“ (pritišćite bijeli gumb i pumpu) sve dok se zaslon ne promijeni tako da prikazuje broj doza u spreju za nos (tj. 10, 20, 30 ili 40 doza) te simbol treperećeg lokota.
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.
Croatian: • Liječnik koji je lijek propisao mora osigurati da bolesnik razumije kako ispravno koristiti Instanyl, u skladu sa Sažetkom opisa svojstava lijeka (SmPC) i Uputom o lijeku, te osigurati da su bolesnici i osobe koje se o njima brinu svjesne rizika povezanih s Instanylom, uključujući rizik predoziranja, pogrešne primjene, ovisnosti i zloupotrebe.
English: A priming sequence of 5 actuations of the nasal spray container is required, indicated by ‘P5', ‘P4', ‘P3', ‘P2' and ‘P1' in the display.
Croatian: Potreban je niz od 5 potisaka spremnika spreja za nos, koja su na zaslonu označena s „P5“, „P4“, „P3“, „P2“ i „P1“.
English: The ‘P' symbol disappears from the display, when the nasal spray is primed again, by spraying once.
Croatian: Simbol „P“ nestaje sa zaslona kada se sprej za nos ponovno pripremi tako što se napravi jedan potisak.
English: Once primed, the display shows the number of doses left and the nasal spray is ready for use again.
Croatian: Nakon pripreme spreja zaslon prikazuje broj preostalih doza i sprej za nos ponovno je spreman za primjenu.
English: After intravenous administration of fentanyl the initial distribution half-life is approximately 6 minutes and a similar half-life is seen after the nasal administration of Instanyl.
Croatian: Nakon intravenske primjene fentanila inicijalni poluvijek distribucije iznosi oko 6 minuta, a slični poluvijek je zabilježen i nakon nazalne primjene Instanyla.
English: The nasal spray is now ready for use, when the next breakthrough pain episode occurs.
Croatian: Sprej za nos sada je spreman za uporabu kada se pojavi sljedeća epizoda probojne boli.
English: The nasal spray is empty when the display shows ‘0' and the lock symbol appears.
Croatian: Sprej za nos je prazan kada zaslon prikazuje „0“ i kada se javlja simbol lokota.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 July 2009
Croatian: Datum prvog odobrenja: 20. srpnja 2009.
English: The initial dose is one puff of 50 micrograms in one nostril each time you have an episode of breakthrough pain.
Croatian: Početna doza je jedan uštrcaj od 50 mikrograma u jednu nosnicu pri svakoj epizodi probojne boli.
English: Clinical data show that fentanyl is absorbed very rapidly through the nasal mucosa.
Croatian: Klinički podaci pokazuju da se fentanil vrlo brzo apsorbira kroz sluznicu nosa.
English: Instanyl should therefore be used with caution in patients with hypotension and/or hypovolaemia.
Croatian: Instanyl stoga treba primjenjivati s oprezom kod bolesnika s hipotenzijom i/ili hipovolemijom.
English: The COUNTDOWN-CLOCK symbol is displayed together with the LOCK-symbol.
Croatian: Simbol ODBROJAVANJA prikazuje se zajedno sa simbolom LOKOTA.
English: Instruction for opening and closing the box: - Pick up the box
Croatian: Upute za otvaranje i zatvaranje kutije - Uzmite kutiju u ruku
English: • The pharmacist must be familiar with the educational material of Instanyl nasal spray before using it in his/her organisation.
Croatian: • Ljekarnik mora poznavati edukacijski materijal o Instanyl spreju za nos prije nego ga koristi u svojoj ustanovi.
English: If you forget to use Instanyl
Croatian: Ako ste zaboravili primijeniti Instanyl
English: Patients with pain who receive chronic opioid therapy develop tolerance to respiratory depression and hence the risk of respiratory depression in these patients may be reduced.
Croatian: Bolesnici s boli koji uzimaju kroničnu opioidnu terapiju razvijaju toleranciju na respiratornu depresiju, te stoga kod njih rizik respiratorne depresije može biti niži.
English: Fentanyl is metabolised primarily in the liver via CYP3A4.
Croatian: Biotransformacija Fentanil se prvenstveno metabolizira u jetri putem CYP3A4.
English: Fentanyl is metabolised mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4), therefore potential interactions may occur when Instanyl is given concurrently with medicinal products that affect CYP3A4 activity.
Croatian: Fentanil se metabolizira većinom putem citokrom P450 3A4 izoenzimskog sustava (CYP3A4), te se stoga potencijalno mogu javiti interakcije ako se Instanyl daje istovremeno s lijekovima koji utječu na aktivnost CYP3A4.
English: About 9 of the dose is recovered in the faeces primarily as metabolites.
Croatian: Oko 9% doze nađeno je u stolici prvenstveno u obliku metabolita.
English: Explanation
Croatian: Objašnjenje
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake kategorije učestalosti nuspojave su navedene slijedom smanjenja ozbiljnosti.
English: On exceptional occasions where a new episode occurs earlier, you can use Instanyl to treat it but you must wait at least 2 hours before doing so.
Croatian: U iznimnim slučajevima kad se nova epizoda javi ranije, možete uzeti Instanyl kako biste je ublažili ali morate pričekati najmanje 2 sata prije nego što to učinite.
English: Generally, the maintenance strength of Instanyl should be increased when a patient requires more than one dose per breakthrough pain episode for several consecutive episodes.
Croatian: Općenito se doza održavanja Instanyla treba povisiti ako je bolesniku kroz nekoliko uzastopnih epizoda probojne boli potrebno više od jedne doze po epizodi.
English: Special care should be taken if you are treated with any of the following medicines: - any medicines which might normally make you sleepy (have a sedative effect) such as sleeping pills, medicines to treat anxiety, antihistamines, or tranquillisers.
Croatian: Poseban oprez je potreban ako primjenjujete neke od sljedećih lijekova: - bilo koji lijek koji izaziva pospanost (djeluje sedirajuće) poput tableta za spavanje, lijekova za liječenje tjeskobe, antihistaminika, ili anksiolitika.
English: Start at 50 micrograms
Croatian: Početna doza 50 mikrograma
English: In a study on pre- and postnatal development the survival rate of offspring was significantly reduced at doses which slightly reduced maternal weight.
Croatian: U ispitivanjima pre- i postnatalnog razvoja preživljavanje potomstva bilo je značajno smanjeno pri dozama koje kod ženke izazivaju blago smanjenje tjelesne težine.
English: The lock symbol starts flashing, when the locking period is over.
Croatian: Simbol lokota počinje treperiti kad istekne razdoblje zaključavanja.
English: Furthermore, Instanyl was significantly superior to placebo in BTP relief at 10, 20, 40, and 60 minutes following administration.
Croatian: Nadalje, Instanyl je bio značajno superioran placebu u ublažavanju probojne boli nakon 10, 20, 40 i 60 minuta od primjene.
English: Remember to press the white button on the side before pumping the nasal spray.
Croatian: Ne zaboravite pritisnuti bijeli gumb sa strane prije nego pritisnete pumpu spreja za nos.
English: If you feel any of the above symptoms you should seek immediate medical assistance.
Croatian: Ako osjetite bilo koji od navedenih simptoma zatražite hitnu medicinsku pomoć.
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).
Croatian: Nuspojave su prema učestalosti javljanja razvrstane u sljedeće kategorije: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000), nepoznato (ne može se ocijeniti na temelju dostupnih podataka).
English: The dose of Instanyl is independent of your usual cancer pain treatment.
Croatian: Doza Instanyla neovisna je o Vašem uobičajenom liječenju boli izazvane rakom.
English: Titration to a higher dose necessitates contact with the health care professional.
Croatian: Titracija do veće doze zahtijeva nadzor zdravstvenog radnika.
English: Comparable bioavailability (AUC) of fentanyl was achieved with and without oxymetazoline, while fentanyl Cmax decreased and Tmax increased by a factor two when oxymetazoline was administered.
Croatian: Postignuta bioraspoloživost (AUC) fentanila bila je usporediva sa ili bez oksimetazolina, dok se Cmax fentanila smanjio, a Tmax povećao za faktor dva kada je primijenjen oksimetazolin.
English: Sedation, myoclonus, paraesthesia, dysaesthesia, dysgeusia
Croatian: Sedacija, mioklonus, parestezija, disestezija, disgeuzija
English: Signs of toxicity are deep sedation, ataxia, miosis, convulsions and respiratory depression, which is the main symptom.
Croatian: Znakovi toksičnosti su duboka sedacija, ataksija, mioza, konvulzije, te respiratorna depresija koja je glavni simptom.
English: In the clinical studies in cancer patients, the most frequent strengths used were 100 and 200 micrograms; however, patients should be titrated to the optimal dose of Instanyl for treating BTP in cancer (see section 4.2).
Croatian: U kliničkim ispitivanjima na bolesnicima s karcinomom najčešće su korištene jačine od 100 i 200 mikrograma; međutim, potrebna je titracija do optimalne doze Instanyla za liječenje probojne boli u bolesnika s karcinomom (vidjeti dio 4.2).
English: In clinical trials elderly patients tend to titrate to a lower effective strength than patients less than 65 years of age.
Croatian: U kliničkim ispitivanjima je titrirana učinkovita doza kod starijih bolesnika težila biti niža od one kod bolesnika mlađih od 65 godina.
English: DK-2630 Taastrup Denmark
Croatian: DK-2630 Taastrup
English: The plasma protein binding of fentanyl is approximately 80.
Croatian: Vezanje fentanila na proteine plazme iznosi oko 80%.
English: The secondary pharmacological effects are respiratory depression, bradycardia, hypothermia, constipation, miosis, physical dependence and euphoria.
Croatian: Sekundarni farmakološki učinci su respiratorna depresija, bradikardija, hipotermija, konstipacija, mioza, fizička ovisnost i euforija.
English: Do not drink alcohol whilst being treated with Instanyl, as it can increase the risk of experiencing dangerous side effects.
Croatian: Za vrijeme liječenja Instanylom ne pijte alkohol, jer može povećati rizik od opasnih nuspojava.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1.8 ml - 10 doses
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU JEDINICA LIJEKA 1,8 ml - 10 doza
English: • CYP3A4 inhibitors such as ketoconazole, itraconazole, or fluconazole (used for treatment of fungal infections);
Croatian: • CYP3A4 inhibitori, poput ketokonazola, itrakonazola ili flukonazola (za liječenje gljivičnih infekcija),
English: Limited data on pharmacokinetics, efficacy and safety are available for the use of Instanyl in patients above 65 years of age.
Croatian: Podaci o farmakokinetici, djelotvornosti i sigurnosti Instanyla u bolesnika starijih od 65 godina su ograničeni.
English: The absolute bioavailability of Instanyl is approximately 89.
Croatian: Apsolutna bioraspoloživost fentanila je približno 89%.
English: • Blow your nose if it feels blocked or you have a cold.
Croatian: • Ispušite nos ako osjećate da je začepljen ili ste prehlađeni.
English: Once the dose has been established according to the steps described above, the patient should be maintained on this strength of Instanyl.
Croatian: Nakon što se prethodno opisanim koracima odredi doza, bolesnika treba održavati na utvrđenoj jačini doze Instanyla.
English: • troleandomycin, clarithromycin, or erythromycin (medicines for treatment of bacterial infections);
Croatian: • troleandomicin, klaritromicin ili eritromicin (za liječenje bakterijskih infekcija),
English: Do not point the nasal spray in the direction of yourself and other people.
Croatian: Ne usmjeravajte sprej za nos u smjeru sebe i drugih osoba.
English: Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Croatian: Bolesnicima koji uzimaju opioidnu terapiju održavanja smatraju se oni koji uzimaju barem 60 mg oralnog morfina dnevno, barem 25 mikrograma transdermalnog fentanila na sat, barem 30 mg oksikodona dnevno, barem 8 mg oralnog hidromorfona dnevno ili ekvivalentnu analgetsku dozu drugog opioida tijekom jednog tjedna ili dulje.
English: • Not to use Instanyl nasal spray to treat any other kind of pain, such as headaches, back pain or toothache.
Croatian: • Neka ne koriste Instanyl sprej za nos za liječenje druge vrste boli, poput glavobolja, boli u leđima ili zubobolje.
English: Frequently, most of these will cease or decrease in intensity with continued use of the medicinal product.
Croatian: Često će većina od njih nestati ili oslabjeti s nastavkom primjene lijeka.
English: • Do not point in the direction of surfaces and objects that could come into contact with other people, particularly children.
Croatian: • ne usmjeravajte prema površinama i predmetima koji bi mogli doći u doticaj s drugim osobama, posebice djecom.
English: Depending on the nasal spray, the starting number can be 10, 20, 30 or 40.
Croatian: Ovisno o spreju za nos, početni broj može biti 10, 20, 30 ili
English: On exceptional occasions where a new episode occurs earlier, patients can use Instanyl to treat it but they must wait at least 2 hours before doing so.
Croatian: U iznimnim slučajevima kad se nova epizoda pojavi ranije, bolesnici mogu primijeniti Instanyl kako bi je ublažili, ali moraju pričekati najmanje 2 sata prije nego što to učine.
English: Redose with same strength.
Croatian: Ponoviti dozu iste jačine.
English: Educational material for the pharmacists should highlight the following:
Croatian: Edukacijski materijal za ljekarnike treba naglasiti sljedeće:
English: Patients should be individually titrated to a dose that provides adequate analgesia with tolerable adverse drug reactions.
Croatian: Dozu treba individualno titrirati do one koja pruža adekvatnu analgeziju uz prihvatljive nuspojave.
English: All three strengths of Instanyl demonstrated statistically significant (p < 0.001) higher pain intensity difference at 10 minutes (PID10) compared with placebo.
Croatian: Instanyla pokazale su statistički značajno (p< 0,001) višu razliku intenziteta boli nakon 10 minuta (RIB10) u usporedbi s placebom.
English: There are no adequate data from the use of fentanyl in pregnant women.
Croatian: Nema odgovarajućih podataka o sigurnost primjene fentanila u trudnica.
English: When the time has passed the lock symbol starts flashing.
Croatian: Kada vrijeme istekne simbol lokota počinje treperiti.
English: • The prescriber must make use of the checklist for prescribers
Croatian: • Propisivač mora koristiti kontrolnu listu za propisivače.
English: • The pharmacist must inform the patients that in order to prevent theft and misuse of Instanyl nasal spray they have to keep it in a safe place to avoid misuse and diversion.
Croatian: • Ljekarnik mora upozoriti bolesnike da radi prevencije krađe i zlouporabe Instanyl spreja za nos, moraju ga čuvati na sigurnom mjestu kako bi se izbjegla zlouporaba ili pogrešna primjena.
English: • gives instruction on number of priming strokes
Croatian: • daje upute o broju napravljenih potisaka za pripremu spreja
English: The spray container contains only one dose.
Croatian: Spremnik sadrži samo jednu dozu.
English: The nasal spray is ready, when the display shows the number of doses (i.e. 10, 20, 30 or 40 doses).
Croatian: Sprej za nos spreman je kada zaslon prikazuje broj doza (tj. 10, 20, 30 ili 40 doza).
English: The initial strength should be one dose of 50 micrograms in one nostril, titrating upwards as necessary through the range of available strengths (50, 100, and 200 micrograms).
Croatian: Terapiju treba započeti jednom dozom jačine 50 mikrograma u jednu nosnicu, te je prema potrebi postupno povećavati kroz raspon dostupnih jačina lijeka (50, 100 i 200 mikrograma).
English: The efficacy and safety of Instanyl (50, 100 and 200 micrograms) have been assessed in two randomised, double-blind, cross-over, placebo-controlled pivotal studies in 279 opioid-tolerant adult cancer patients (age 32-86 years) with breakthrough pain (BTP).
Croatian: Djelotvornost i sigurnost Instanyla (50, 100 i 200 mikrograma) ocijenjena je u dva randomizirana, dvostruko slijepa, križna, placebom kontrolirana pivotalna ispitivanja na 279 odrasla bolesnika s karcinomom i probojnom boli (dob 32-86 godina) koji su tolerantni na opioide.
English: Physicians should keep in mind the potential of abuse, misuse, addiction and overdose of fentanyl.
Croatian: Liječnici trebaju imati na umu mogućnost zloupotrebe, pogrešne primjene, ovisnosti i predoziranja fentanilom.
English: Prolonged treatment with fentanyl during pregnancy may cause withdrawal symptoms in the newborn which can be life-threatening (see section 2)
Croatian: Produljeno liječenje fentanilom u trudnoći može u novorođenčadi prouzročiti simptome ustezanja koji mogu biti opasni za život (pogledajte dio 2).
English: Therefore, the patient must be instructed that the priming should be conducted in a well ventilated area, pointing away from the patient and other people, and away from surfaces and objects that could come into contact with other people, particularly children.
Croatian: Stoga bolesnika treba uputiti da pripremu spreja mora provesti u dobro prozračenom prostoru raspršujući lijek u smjeru suprotnom od bolesnika i drugih osoba i podalje od površina i predmeta koji bi mogli doći u doticaj s drugim osobama, posebice djecom.
English: The dose of Instanyl for treatment of breakthrough pain was independent of the daily maintenance dose of opioid in the clinical studies (see section 5.1).
Croatian: Doza Instanyla za liječenje probojne boli u kliničkim ispitivanjima nije ovisila o dnevnoj dozi opioida u terapiji održavanja (vidjeti dio 5.1).
English: Evaluation of brain slides from the carcinogenicity study in rats revealed brain lesions in animals administered high doses of fentanyl citrate.
Croatian: Pregled rezova mozgova štakora na kojima je ispitivana kancerogenost pokazao je lezije mozga u životinja kojima su davane visoke doze fentanil citrata.
English: The use of concomitant central nervous system depressants may increase the risk of respiratory depression (see section 4.5).
Croatian: Istovremena primjena drugih depresora središnjeg živčanog sustava može povećati rizik depresije disanja (vidjeti dio 4.5).
English: When you first start using Instanyl, your doctor will work with you to find the dose that will relieve your breakthrough pain.
Croatian: Kad započinjete liječenje Instanylom, liječnik će u suradnji s Vama pronaći optimalnu dozu za ublažavanje probojne boli.