natgillin/translations-raw huggingface dataset:
They have high affinity to opioid receptors with relatively low intrinsic activity and therefore partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependent patients.
Imaju visok afinitet prema opioidnim receptorima s razmjerno niskim intrinzičkim djelovanjem, te stoga djelomično antagoniziraju analgetsko djelovanje fentanila i mogu kod bolesnika s ovisnošću o opioidima izazvati simptome ustezanja.
If adverse reactions are intolerable or persistent, the strength should be reduced or treatment with Instanyl be replaced by other analgesics.
U slučaju loše podnošljivosti i ustrajnih nuspojava, jačinu doze treba smanjiti ili liječenje Instanylom zamijeniti drugim analgeticima.
hydromorphone, morphine, oxycodone, pethidine), every day on a regular schedule, for at least a week, to control your persistent pain.
hidromorfon, morfin, oksikodon, petidin) redovito, svaki dan prema rasporedu, najmanje tjedan dana.
In these patients, opioids may decrease respiratory drive.
Kod tih bolesnika opioidi mogu smanjiti nagon za disanjem.
Elderly patients may have a reduced clearance, a prolonged half-life and higher sensitivity to fentanyl than younger patients.
Stariji bolesnici mogu imati smanjeni klirens, produljeni poluvijek i veću osjetljivost na fentanil u odnosu na mlađe bolesnike.
Precautions to be taken before handling or administering the medicinal product Before using Instanyl for the first time, the nasal spray must be primed until a fine mist appears; 3 to 4 actuations of the nasal spray are usually required.
Mjere opreza koje je potrebno poduzeti prije rukovanja ili primjene lijeka Prije prve primjene Instanyla, sprej za nos mora se pripremiti ispuštanjem doza u zrak sve do pojave fine maglice; obično su za to potrebna 3 do 4 potiska spreja za nos.
In a pharmacokinetic interaction study it was found that the maximum plasma concentration of nasally applied fentanyl was reduced about 50% by the concomitant use of oxymetazoline, while the time to reach Cmax (Tmax) was doubled.
U farmakokinetskim ispitivanjima interakcija pokazalo se da se pri istovremenoj primjeni oksimetazolina maksimalna plazmatska koncentracija intranazalno primjenjenog fentanila smanjuje za oko 50%, dok se vrijeme do postizanja Cmax (Tmax) udvostručuje.
This observation was most distinct for patients receiving Instanyl 50 micrograms.
To je opažanje najizraženije bilo kod bolesnika koji su u terapiji održavanja primali Instanyl 50 mikrograma.
Caution should therefore be taken in treatment of elderly, cachectic or debilitated patients.
Stoga je potreban oprez u liječenju starijih, kahektičnih bolesnika ili bolesnika narušenog zdravstvenog stanja.
Do not point in the direction of surfaces and objects that could come into contact with other people, particularly children.
Ne usmjeravajte prema površinama i predmetima koji bi mogli doći u doticaj s drugim osobama, posebice djecom.
System organ class
Klasifikacije organskih sustava
• ritonavir, nelfinavir, amprenavir, and fosamprenavir (medicines that help control HIV infection);
• ritonavir, nelfinavir, amprenavir i fosamprenavir (lijekovi za kontrolu HIV infekcije),
A polypropylene (PP) nasal spray container consisting of a glass bottle (brown Type 1 glass) with metering pump.
Polipropilenski (PP) spremnik spreja za nos sastavljen od staklene bočice (smeđe staklo tipa 1) s odmjernom pumpom.
5.0 ml - 40 doses
5,0 ml - 40 doza
The nasal spray is now ready for use.
Sprej za nos sada je spreman za primjenu.
The display now shows ‘P3' and the lock symbol.
Zaslon sada prikazuje „P3“ i simbol lokota.
The following adverse reactions have been reported with Instanyl and/or other fentanyl-containing compounds during clinical studies and post marketing experience:
Sljedeće su nuspojave prijavljene s Instanylom i/ili drugim lijekovima koji sadrže fentanil tijekom kliničkih ispitivanja te nakon stavljanja lijeka u promet.
Keep track of how many doses you have used and how many you have left in your nasal spray by using the dose-counting card provided with Instanyl nasal spray.
Pratite koliko ste doza upotrijebili i koliko vam ih je ostalo u spreju za nos s pomoću kartice za brojanje doza koja dolazi uz Instanyl sprej za nos.
Patients being treated with medicinal products containing sodium oxybate.
Bolesnici liječeni lijekovima koji sadrže natrijev oksibat.
Each single-dose container contains only one dose.
Svaki jednodozni spremnik sadrži samo jednu dozu.
The elimination half-life is approximately 3-4 hours for Instanyl in cancer patients.
Poluvijek eliminacije kod bolesnika s karcinomom za Instanyl iznosi približno 3 do 4 sata.
Hallucination, drug dependence (addiction), drug abuse
Halucinacije, ovisnost o lijeku, zlouporaba lijeka
• For the multi-dose nasal spray: information about the dose counting scheme.
• Za višedozni sprej za nos: informacije o načinu brojanja doza.
Instanyl incorporates an electronic dose counter, and a lock out period between doses to minimise the risk of accidental overdose, misuse and abuse and to provide some reassurance to patients regarding these risks.
Instanyl ima ugrađen elektronski brojač doza i razdoblje zaključavanja između doza kako bi se smanjio rizik slučajnog predoziranja, pogrešne uporabe i zloporabe te bolesnicima pružila određena sigurnost u vezi tih rizika.
Concomitant use of medicinal products containing sodium oxybate and fentanyl is contraindicated (see section 4.3).
Istovremena primjena lijekova koji sadrže natrijev oksibat i fentanil je kontraindicirana (vidjeti dio 4.3).
It is recommended that concomitant use of nasal decongestants is avoided (see section 5.2).
Preporučuje se izbjegavati istovremenu primjenu nazalnih dekongestiva (vidjeti dio 5.2).
Severe respiratory depression or severe obstructive lung conditions.
Teška respiratorna depresija ili teška opstruktivna bolest pluća.
Instanyl should be used with caution in patients with cerebral tumour or head injury.
Instanyl treba primjenjivati s oprezom kod bolesnika s tumorom mozga ili ozljedom glave.
The safety and efficacy of Instanyl have been evaluated in patients taking the medicinal product at the onset of a breakthrough pain episode.
Sigurnost primjene i djelotvornost lijeka Instanyl ispitivale su se u bolesnika koji su lijek uzimali na početku epizode probojne boli.
If Instanyl nasal spray is frozen the spray pump may crack.
Ako se Instanyl smrzne, pumpica spreja može puknuti.
A pharmacokinetic study has shown that Instanyl single-dose and multi-dose nasal spray are bioequivalent.
Farmakokinetska ispitivanja su pokazala da su jednodozni i višedozni sprej za nos bioekvivalentni.
Sleepiness, drowiness, dizziness, reduced body temperature, slow heart beat, difficulties coordinating arms and legs.
Pospanost, omamljenost, omaglica, snižena tjelesna temperatura, usporeni otkucaji srca, teškoće u koordinaciji ruku i nogu.
No distinct correlation between the maintenance opioid dose and Instanyl doses have been established, however in the second pivotal study patients receiving low maintenance opioid dose tended to achieve effective pain relief with a lower strength of Instanyl compared to patients taking higher levels of maintenance opioid dose.
Nije ustanovljena direktna povezanost između doze opioida u terapiji održavanja kronične boli i doze Instanyla, međutim u drugom pivotalnom ispitivanju su bolesnici koji su primali niže doze opioida u terapiji održavanja u pravilu postizali efektivno ublažavanje bola s nižom dozom Instanyla u usporedbi s bolesnicima koji su u terapiji održavanja koristili više doze opioida.
• Instanyl nasal spray should not be used to treat any other short-term pain or pain status.
• Instanyl sprej za nos se ne smije koristiti za liječenje druge kratkotrajne boli ili bolnog stanja.
During the determination of your right dose, your doctor may instruct you to change to a higher dose.
Pri određivanju odgovarajuće doze liječnik može preporučiti prelazak na višu dozu.
• Priming should be performed in a well ventilated area.
• pripremu spreja treba provesti u dobro prozračenom prostoru;
Pack sizes: 2, 6, 8 and 10 single-dose containers.
Veličine pakiranja: 2, 6, 8 ili 10 jednodoznih spremnika.
Instanyl should not be used during pregnancy unless you have discussed this with your doctor.
Instanyl se tijekom trudnoće ne smije koristiti bez savjetovanja s liječnikom.
After each dose, the number is counting downwards on the display.
Nakon svake doze na zaslonu se prikaže jedan broj manje.
• To open cut with scissors along the line (above the scissors symbol) on the blister.
• Blister otvorite odrezavši ga škarama uzduž crte označene na blisteru (iznad oznake škara).
2.9 ml - 20 doses
2,9 ml - 20 doza
For concomitant use of nasal vasoconstrictor see section 4.5.
Za istovremenu primjenu intranazalnog vazokonstriktora vidjeti dio 4.5.
Throat irritation Respiratory depression, epistaxis, nasal ulcer, rhinorrhea
Respiratorna depresija, epistaksa, ulceracija nosa, rinoreja
You will hear a ‘click' sound when the pump is pressed down completely and the nasal spray has delivered the dose.
8. Začut ćete zvuk „klik“ kada je pumpica pritisnuta do kraja, a sprej za nos isporuči dozu u nos.
After two doses are taken within 60 minutes, Instanyl will lock for a period of 2 hours, from the first dose taken, until another dose can be administered.
Nakon primjene dvije doze unutar 60 minuta Instanyl će se zaključati na razdoblje od 2 sata od prve uzete doze prije nego što se može primijeniti sljedeća doza.
What Instanyl looks like and contents of the pack Instanyl is a nasal spray, solution in a single-dose spray container.
Kako Instanyl izgleda i sadržaj pakiranja Instanyl je sprej za nos, otopina u jednodoznom spremniku.
When priming, please refer to the above safety instructions.
Prilikom pripreme spreja slijedite gore navedene upute za sigurnu primjenu.
Symptoms of overdose are:
Znaci predoziranja su:
However, opioid analgesics are known to impair the mental and/or physical ability required for driving or operating machinery.
Međutim, poznato je da opioidni analgetici smanjuju umne i/ili fizičke sposobnosti potrebne pri upravljanju vozilima i radu na strojevima.
Subjects with allergic rhinitis received oxymetazoline nasal spray one hour prior to Instanyl.
Ispitanici s alergijskim rinitisom primili su oksimetazolin sprej za nos jedan sat prije Instanyla.
Other signs may be hypothermia, decreased muscle tonus, bradycardia and hypotension.
Također se mogu javiti ostali znakovi kao hipotermija, smanjeni tonus mišića, bradikardija i hipotenzija.
If severe or persistent hypotension occurs, hypovolemia should be considered and the condition should be managed with appropiate parenteral fluid therapy.
Ako se javi teška ili trajna hipotenzija, treba uzeti u obzir hipovolemiju i liječiti je primjerenom parenteralnom nadoknadom tekućine.
You should however continue to take your usual pain relieving medicine to treat your cancer pain.
Međutim, nastavite primjenjivati vašu uobičajenu terapiju za ublažavanje boli izazvane rakom.
Fentanyl should be used with caution in patients with evidence of increased intracranial pressure, impaired consciousness or coma.
Fentanil treba primjenjivati s oprezom kod bolesnika sa znakovima povišenog intrakranijalnog tlaka, poremećajima svijesti ili komom.
However, higher values for Tmax were observed in a dose-proportionality study in healthy volunteers.
Međutim, u ispitivanju proporcionalnosti doza na zdravim dobrovoljcima zabilježene su više vrijednosti Tmax.
The influence of hepatic and renal impairment on the pharmacokinetics of Instanyl have not been evaluated; however, when administered intravenously the clearance of fentanyl has shown to be altered due to hepatic and renal impairment caused by alterations in metabolic clearance and plasma proteins.
Utjecaj poremećaja funkcije jetre i bubrega na farmakokinetiku Instanyla nije ispitan; međutim, poznato je da oštećena funkcija bubrega ili jetre mijenjaju klirens fentanila nakon intravenske primjene zbog promjena metaboličkog klirensa i proteina plazme.
The nasal spray allows for up to two doses per breakthrough pain episodes.
Sprej za nos omogućava do dvije doze po epizodi probojne boli.
If your breakthrough pain is not relieved after 10 minutes, you may use only one puff more for this episode.
Ukoliko probojna bol ne prestane nakon 10 minuta, možete primijeniti još samo jedan uštrcaj za istu epizodu.
If discontinuation of all opioid therapy is required, the patient must be closely followed by the physician as gradual downward opioid titration is necessary in order to avoid the possibility of abrupt withdrawal effects.
Ako je potrebno prekinuti svu terapiju opioidima, bolesnika mora nadzirati liječnik jer je zbog izbjegavanja mogućih simptoma naglog ustezanja doze opioida potrebno postupno titrirati na niže.
Precautions to be taken before handling or administering the medicinal product Before using Instanyl for the first time, the nasal spray must be primed.
Mjere opreza koje je potrebno poduzeti prije rukovanja ili primjene lijeka Prije prve primjene Instanyla, sprej za nos je potrebno pripremiti.
Consider next higher strength for next episode
Razmotriti sljedeću primjenu doze veće jačine u sljedećoj epizodi boli.
• The pharmacist should be aware that off label prescription and suspected abuse or misuse of Instanyl should be reported according to your local guidelines for adverse reactions reporting.
• Ljekarnik mora biti svjestan da se propisivanje izvan indikacije i sumnja na pogrešnu primjenu Instanyla moraju prijaviti sukladno lokalnim smjernicama za prijavljivanje nuspojava.
Educational material for the patients should contain the following:
Edukacijski materijal za bolesnike treba sadržavati sljedeće:
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose
SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU JEDINICA LIJEKA 1 doza
In order to keep track of the number of doses of Instanyl used, you should use the tick-boxes in the booklet placed on top of the child-resistant outer box.
Kako biste održali nadzor nad brojem iskorištenih doza Instanyla, koristite kvadratiće za označavanje u knjižici na vrhu kutije sigurne za djece.
Takeda GmbH Robert-Bosch-Strasse 8 D - 78224 Singen Germany
Takeda GmbH Robert-Bosch-Strasse 8 D-78224 Singen Njemačka
Press the white button on the side of the nasal spray (the flashing lock symbol disappears).
4. Pritisnite bijeli gumb sa strane spreja za nos (trepereći simbol lokota nestaje).
If the clinical situation warrants, a patent airway should be established and maintained, possibly with an oropharyngeal airway or endotracheal tube and oxygen should be administered and respiration assisted or controlled, as appropriate.
Ukoliko to zahtijeva klinička situacija, potrebno je kod bolesnika uspostaviti i održavati dišni put, moguće orofaringealnim tubusom ili endotrahealnim tubusom, te primijeniti kisik ili mehaničku ventilaciju ukoliko je potrebno.
Please read the instruction for use at the end of this leaflet to learn how to use Instanyl.
Pročitajte uputu za uporabu na kraju ove upute kako biste naučili kako primjenjivati Instanyl.
The concomitant use of partial opioid agonists/antagonists (e.g. buprenorphine, nalbuphine, pentazocine) is not recommended.
Istovremena primjena parcijalnih opioidnih agonista/antagonista (npr. buprenorfin, nalbufin, pentazocin) se ne preporučuje.
Administration of Instanyl in single doses ranging from 50 to 200 micrograms fentanyl per dose in opioid tolerant cancer patients produces a rapid Cmax level of 0.35 to 1.2 ng/ml.
Primjenom jednostruke doze u rasponu od 50 do 200 mikrograma fentanila kod bolesnika s karcinomom koji podnose opioide brzo se postiže Cmax razina od 0,35 do 1,2 ng/ml.
Typical opioid adverse reactions are to be expected with Instanyl.
Uz Instanyl treba očekivati nuspojave tipične za opioide.
It is advised not to use fentanyl during labour and delivery (including caesarean section) because fentanyl passes through the placenta and may cause respiratory depression in the newborn (neonate).
Preporučuje se ne primjenjivati fentanil tijekom trudova i porođaja (uključujući i carski rez), budući da prolazi placentu i može prouzročiti respiratornu depresiju kod novorođenčeta.
Instanyl should be discontinued immediately if the patient no longer experiences breakthrough pain episodes.
Primjenu Instanyla treba odmah prekinuti ako bolesnik više ne pati od epizoda probojne boli.
Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.
Probojna bol je prolazna egzacerbacija boli koja se javlja povrh inače kontrolirane trajne boli.
2 single-dose containers 6 single-dose containers 8 single-dose containers 10 single-dose containers
2 jednodozna spremnika 6 jednodoznih spremnika 8 jednodoznih spremnika 10 jednodoznih spremnika
The clinical experience with Instanyl in patients with background opioid treatment equivalent to ≥ 500 mg/day morphine or ≥ 200 micrograms/hour transdermal fentanyl is limited.
Kliničko iskustvo s Instanylom kod bolesnika koji u terapiji održavanja koriste opioide u dozi koja odgovara ≥ 500 mg/dan morfina ili ≥ 200 mikrograma/sat transdermalnog fentanila je ograničeno.
The treatment for the persistent background pain should be kept as prescribed.
Trajnu terapiju kronične boli treba nastaviti kako je propisano.
• Only to use Instanyl nasal spray if they are using other opioid pain medicine on a daily basis.
• Da Instanyl sprej za nos koriste samo ako već svakodnevno koriste drugi opioidni analgetik.
These actions can be followed by administration of a specific opioid antagonist such as naloxone.
Može ih slijediti primjena specifičnog opioidnog antagonista poput naloksona.
Manufacturer Takeda GmbH Robert-Bosch-Strasse 8 D - 78224 Singen Germany
Proizvođač Takeda GmbH Robert-Bosch-Strasse 8 D-78224 Singen Njemačka
It is recommended that the patient sit or stand in upright position when administrating Instanyl.
Preporučuje se da pri primjeni Instanyla bolesnik uspravno sjedi ili stoji.
DoseGuard Clear, colourless solution.
DoseGuard Bistra, bezbojna otopina.
The symbol disappears from the display, when the white button on the side of the nasal spray is pressed.
Simbol nestaje sa zaslona kada se pritisnite bijeli gumb sa strane spreja.
There are no human data on fertility available.
Nema podataka o utjecaju na plodnost kod ljudi.
Instanyl contains the active substance fentanyl and belongs to a group of strong painkillers called opioids.
Instanyl sadrži djelatnu tvar fentanil i pripada skupini jakih analgetika (lijekova za ublažavanje boli) koje zovemo opioidima.
The signs and symptoms of fentanyl overdose are expected to be an extension of its pharmacological actions e.g. lethargy, coma and severe respiratory depression.
Znakovi i simptomi predoziranja fentanilom proširenje su njegovog farmakološkog djelovanja, poput letargije, kome i teške respiratorne depresije.
Instanyl comes in different pack sizes of 2, 6, 8 and 10 single-dose containers.
Instanyl je dostupan u pakiranjima sa 2, 6, 8 ili 10 jednodoznih spremnika.
Store below 30 C.
Čuvati na temperaturi ispod 30 °C.
Cachectic patients may have reduced clearance of fentanyl.
Kahektični bolesnici mogu imati smanjeni klirens fentanila.
Instanyl should not be used during childbirth because fentanyl may cause serious breathing problems in the new-born child.
Instanyl se ne smije koristiti tijekom trudova i porođaja jer kod novorođenčeta može izazvati ozbiljne teškoće s disanjem.
Treatment should be initiated by and remain under the supervision of a physician experienced in the management of opioid therapy in cancer patients.
Liječenje treba započeti i nadzirati liječnik s iskustvom u primjeni opioidne terapije u bolesnika s karcinomom.
In a fertility and early embryonic development study in rats, a male-mediated effect was observed at high doses (300 µg/kg/day, s.c.) and is consistent with the sedative effects of fentanyl in animal studies.
U ispitivanju plodnosti i rane embrionalne razvojne toksičnosti kod životinja, kod mužjaka štakora je uočen učinak kod visokih doza (300 μg/kg/dan, s.c.) koji odgovara sedativnom djelovanju fentanila.
The most serious adverse reactions are respiratory depression (potentially leading to apnoea or respiratory arrest), circulatory depression, hypotension and shock and all patients should be closely monitored for these.
Najozbiljnije nuspojave su respiratorna depresija (koja potencijalno vodi do apneje ili respiratornog zastoja), cirkulatorna depresija, hipotenzija i šok, te zbog njihove moguće pojave treba posebno pratiti sve bolesnike.
If Instanyl nasal spray is blocked or does not spray properly:
Ako je Instanyl sprej za nos blokiran ili se lijek ne istiskuje pravilno:
: +32 2 464 06 11 takeda-belgium@takeda.com
Tel./Tél.: +32 2 464 06 11 takeda-belgium@takeda.com
• Only the patient or carer should handle the nasal spray as it contains medication that is attractive for people to abuse.
• Sa sprejem za nos smiju rukovati samo bolesnik ili osoba koja se za njega skrbi jer sadrži lijek koji je privlačan za zloupotrebu.
Hold the edge of the foil, peel the foil back and take the nasal spray out.
Držite rub folije, odvojite foliju povlačenjem i uzmite sprej za nos.
Bend your head slightly forward.
5. Nagnite glavu blago prema naprijed.
• aprepitant (used to treat severe nausea);
• aprepitant (za suzbijanje mučnine),
The display counts down one number and the lock symbol is displayed shortly.
Zaslon prikaže jedan broj manje i nakratko se pojavljuje simbol lokota. 10.
Manufacturer Takeda Pharma A/S Dybendal Alle 10 DK-2630 Taastrup Denmark
Proizvođač Takeda Pharma A/S Dybendal Alle 10 DK-2630 Taastrup Danska
In animal studies, male and female fertility was impaired at sedative doses (see section 5.3).
U studijama na životinjama sedativne doze su kod mužjaka i ženki izazvale smanjenje plodnosti (vidjeti dio 5.3).
Priming should be performed in a well ventilated area.
Pripremu spreja treba provesti u dobro prozračenom prostoru.
In patients with chronic obstructive pulmonary diseases, fentanyl may have more severe adverse reactions.
Kod bolesnika s kroničnom opstruktivnom plućnom bolesti nuspojave fentanila mogu biti teže.
If you experience withdrawal symptoms, you should contact your doctor.
Osjećate li simptome ustezanja, obratite se liječniku.
• Only to use Instanyl nasal spray if they have received the proper information regarding the use of the device and the safety precautions from the prescriber and/or the pharmacist.
• Da Instanyl sprej za nos koriste samo ako su im propisivač i/ili farmaceut dali odgovarajuće upute o korištenju spreja za nos i mjerama opreza.
10 doses (2.0 ml) 20 doses (3.2 ml) 30 doses (4.3 ml) 40 doses (5.3 ml)
10 doza (2,0 ml) 20 doza (3,2 ml) 30 doza (4,3 ml) 40 doza (5,3 ml)
• Do not point the nasal spray in the direction of yourself and other people.
• ne usmjeravajte sprej za nos prema sebi i drugim osobama;
A drug-drug-interaction study was performed with a nasal vasoconstrictor (oxymetazoline).
Ispitivanje interakcija s drugim lijekom provedeno je s nazalnim vazokonstriktorom (oksimetazolin).
How to remove and re-attach the child-resistant cap Remove the child-resistant cap by pressing on both sides of the cap, and then turn the cap counter clockwise and lift it off.
Kako skinuti i ponovno staviti zatvarač siguran za djecu Skinite zatvarač siguran za djecu pritiskom na obje strane zatvarača i potom okrenite zatvarač u smjeru suprotnom od kretanja kazaljke na satu i podignite ga.
Educational material for the physicians should contain the following:
Edukacijski materijal za liječnike treba sadržavati sljedeće:
An in-built lock-out mechanism which controls how often the nasal spray can be used A child-resistant cap, which must be put on the nasal spray, when the nasal spray is not used An electronic display which:
Sprej za nos Instanyl ima: ugrađeni mehanizam za zaključavanje koji kontrolira kako se često sprej za nos može koristiti zatvarač siguran za djecu koji se mora staviti na sprej za nos kada se sprej ne koristi elektronički zaslon koji