Sta Znaci INSTANYLA na Engleskom - Engleski Prijevod

• instanyl

Primjeri korištenja Instanyla na Hrvatski i njihovi prijevodi na Engleskom

Primijeniti jednu dozu Instanyla.
Use one dose of Instanyl.

Doza Instanyla neovisna je o uobičajenoj dozi lijeka za trajnu bol kod raka.
The dose of Instanyl is independent of your usual cancer pain treatment.

To može smanjiti djelotvornost Instanyla.
This may reduce the efficacy of Instanyl.

Ne mijenjajte samovoljno dozu Instanyla ili drugih lijekova protiv boli.
Do not change the dose of Instanyl or your other pain medicines on your own.

Primjereno ublažavanje boli s jednom dozom Instanyla.
Adequate pain relief with one dose of Instanyl.

Doze Instanyla više od 400 mikrograma nisu ispitane u kliničkim ispitivanjima.
Instanyl in doses above 400 micrograms have not been evaluated in clinical trials.

Stoga nije moguće pouzdano odvojiti učinke samog Instanyla.
Thus, it is not possible to definitively separate the effects of Instanyl alone.

Sigurnost i djelotvornost Instanyla u djece u dobi do 18 godina nisu još ustanovljene.
The safety and efficacy of Instanyl in children aged below 18 years have not yet been established.

Klinička ispitivanja pokazala su djelotvornost i sigurnost Instanyla.
The clinical studies demonstrated the efficacy and safety of Instanyl.

Jednodozni spremnik sadrži 1 dozu Instanyla i pakiran je u blisteru sigurnom za djecu.
The single-dose container contains 1 dose of Instanyl and and is supplied in a child-resistant blister.

Ispitanici s alergijskim rinitisom primili su oksimetazolin sprej za nos jedan sat prije Instanyla.
Subjects with allergic rhinitis received oxymetazoline nasal spray one hour prior to Instanyl.

Linearnost doze od 50 mikrograma do 400 mikrograma Instanyla pokazana je na zdravim ispitanicima.
Dose linearity from 50 micrograms to 400 micrograms of Instanyl has been demonstrated in healthy subjects.

Istovremena primjena lijekova koji induciraju 3A4 aktivnost može smanjiti djelotvornost Instanyla.
Co-administration with medicinal products that induce 3A4 activity may reduce the efficacy of Instanyl.

Klinička ispitivanja Instanyla dizajnirana su da se ocijeni sigurnost i djelotvornost u liječenju probojne boli.
The clinical trials of Instanyl were designed to evaluate safety and efficacy in treating breakthrough pain.

Prije prve primjene spreja za nos mora se napraviti 5 potisaka u zrak(priprema spreja) kako bi se postiglo istiskivanje pune doze Instanyla.
Before using the nasal spray for the first time, it must be pumped 5 times(primed) to give a full dose of Instanyl.

Podaci o farmakokinetici, djelotvornosti i sigurnosti Instanyla u bolesnika starijih od 65 godina su ograničeni.
Limited data on pharmacokinetics, efficacy and safety are available for the use of Instanyl in patients above65 years of age.

Istovremena primjena Instanyla s drugim lijekovima(osim oksimetazolina) koji se primjenjuju u nos nije ispitana u kliničkim ispitivanjima.
Concomitant use of Instanyl with other medicinal products(other than oxymetazoline) administered via the nose has not been evaluated in the clinical trials.

Bolesnici uključeni u drugo pivotalno ispitivanje ranije su sudjelovali u farmakokinetskom ispitivanju Instanyla ili u prvom pivotalnom ispitivanju.
Patients in the second pivotal study had earlier participated in the Instanyl pharmacokinetic study or in the first pivotal study.

Ispitivanje lokalne podnošljivosti Instanyla na patuljastim svinjama pokazalo je da se primjena Instanyla dobro podnosi.
Local tolerance studies with Instanyl in mini-pigs demonstrated that Instanyl administration was well tolerated.

Nakon intravenske primjene fentanila inicijalni poluvijek distribucije iznosi oko 6 minuta, a slični poluvijek je zabilježen i nakon nazalne primjene Instanyla.
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.

Sve tri jačine Instanyla pokazale su statistički značajno(p< 0,001) višu razliku intenziteta boli nakon 10 minuta(RIB10) u usporedbi s placebom.
All three strengths of Instanyl showed statistically significant(p< 0.001) higher pain intensity difference at 10 minutes(PID10) compared with placebo.

Što morate znati prije nego počnete primjenjivati Instanyl Nemojte primjenjivati Instanyl: ako ste preosjetljivi(alergični) na fentanil ili bilo koji drugi sastojak Instanyla; ako za kontrolu stalne boli ne koristite propisani opioidni lijek(npr. kodein, fentanil, hidromorfon, morfin, oksikodon, petidin) redovito, svaki dan prema rasporedu, najmanje tjedan dana.
What you need to know before you use Instanyl Do not use Instanyl: if you are hypersensitive( allergic) to fentanyl or any of the other ingredients of Instanyl; if you are not regularly using a prescribed opioid medicine( e. g codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine), every day on a regular schedule, for at least a week, to control your persistent pain.

Doza Instanyla za liječenje probojne boli u kliničkim ispitivanjima nije ovisila o dnevnoj dozi opioida u terapiji održavanja vidjeti dio 5.1.
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.

Kako biste održali nadzor nad brojem iskorištenih doza Instanyla, koristite kvadratiće za označavanje u knjižici na vrhu kutije sigurne za djece.
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.

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(dob 32-86 godina) na kroničnoj terapiji s opioidima i s probojnom boli.
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.

Rezultati sumarne RIB nakon 60 minuta(SRIB0-60) pokazuju da sve jačine Instanyla imaju značajno višu srednju SRIB0-60 u usporedbi s placebom(p< 0,001), ukazujući na bolju kontrolu boli Instanylom u usporedbi s placebom tijekom 60 minuta.
The results of summary of PID at 60 minutes(SPID0-60) showed that all strengths of Instanyl had significantly higher mean SPID0-60 scores compared with placebo(p0.001) demonstrating better pain relief of Instanyl compared to placebo during 60 minutes.

Istovremena primjena Instanyla s jakim CYP3A4 inhibitorima( npr. ritonavir, ketokonazol, itrakonazol, troleandomicin, klaritromicin i nelfinavir) ili umjerenim CYP3A4 inhibitorima( npr. amprenavir, aprepitant, diltiazem, eritromicin, flukonazol, fosamprenavir i verapamil) može za posljedicu imati porast plazmatske koncentracije fentanila, te moguće izazivanje ozbiljnih nuspojava uključujući i fatalnu respiratornu depresiju.
The concomitant use of Instanyl with strong CYP3A4 inhibitors(e.g. ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, and nelfinavir) or moderate CYP3A4 inhibitors(e.g., amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, and verapamil) may result in increased fentanyl plasma concentrations, potentially causing serious adverse drug reactions including fatal respiratory depression.

U ozbiljnim slučajevima prekomjerno uzimanje Instanyla može izazvati komu, sedaciju, konvulzije ili izrazite teškoće s disanjem vrlo usporeno ili plitko disanje.
In serious cases taking too much Instanyl may cause coma, sedation, convulsions or severe breathing difficulties very slow or shallow breathing.

Očekuje se da je prije titracije Instanyla trajna bol kod bolesnika kontrolirana primjenom kronične opioidne terapije, te da se epizode probojne boli ne javljaju češće od četiri puta dnevno.
Before patients are titrated with Instanyl, it is expected that their background persistent pain is controlled by use of chronic opioid therapy and that they are experiencing no more than four episodes of breakthrough pain per day.

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 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.