natgillin/translations-raw huggingface dataset:
The clinical studies of PecFent were designed to evaluate safety and efficacy in treating BTP and all patients were also on background opioid therapies, such as sustained-release morphine or transdermal fentanyl, for their persistent pain.
Klinične študije zdravila PecFent so bile zasnovane za ocenjevanje varnosti in učinkovitosti zdravljenja BTP in vsi bolniki so bili zaradi dolgotrajne bolečine tudi na osnovnih opioidnih terapijah, na primer na morfinu s stalnim sproščanjem ali transdermalnem fentanilu.
• medicines that might have an effect on the way your body breaks down PecFent.
• zdravila, ki bi lahko vplivala na to, kako vaše telo razgrajuje zdravilo PecFent.
Immediate management of opioid overdose includes ensuring a patent airway, physical and verbal stimulation of the patient, assessment of the level of consciousness, ventilatory and circulatory status, and assisted ventilation (ventilatory support) if necessary.
Takojšnje zdravljenje prevelikega opioidnega odmerka vključuje zagotavljanje odprtih dihalnih poti, telesno in besedno spodbujanje bolnika, oceno ravni zavesti in stanja dihal in krvnih obtočil ter po potrebi asistirano ventilacijo (podporo dihanja).
If adverse reactions are intolerable or persistent, the dose should be reduced or treatment with PecFent replaced by another analgesic.
Če neželenih učinkov ni mogoče prenašati ali so dolgotrajni, je treba odmerek zmanjšati ali pa zdravljenje z zdravilom PecFent zamenjati z drugim analgetikom.
In a fertility and early embryonic development study in rats, a male-mediated effect was observed at high doses (300 mcg/kg/day, s.c.) and is consistent with the sedative effects of fentanyl in animal studies.
V študiji plodnosti in zgodnjega embrionalnega razvoja pri podganah so opazili učinek, prenesen preko samcev, pri velikih odmerkih (300 mikrogramov/kg/dan, s.c.), ki je skladen s sedativnimi učinki fentanila v študijah na živalih.
In studies on pre and postnatal development in rats the survival rate of offspring was significantly reduced at doses causing severe maternal toxicity.
V študijah prenatalnega in postnatalnega razvoja pri podganah se je preživetje potomstva pri odmerkih, ki so povzročali težko toksičnost za mater, značilno zmanjšalo.
• The PecFent nasal spray dose strengths can not be compared with other PecFent products
• jakosti odmerkov pršila za nos PecFent niso primerljive z drugimi izdelki PecFent;
Firmly press down on the finger grips until a ‘click' is heard and then let go of the grips (Figure 2).
Čvrsto pritisnite na sprožilec, dokler ne slišite ‘klik', nato ju spustite (slika 2).
It should be noted that although statistically significant increases in Cmax levels were seen following a second dose of PecFent given either one or two hours after the initial dose, this increase is not considered to be large enough to suggest that clinically concerning accumulation or over-exposure would occur, providing a wide safety margin for the recommended dose interval of four hours.
Čeprav so po drugem odmerku zdravila PecFent, danega bodisi eno ali dve uri po začetnem odmerku, ugotovili statistično značilno zvečanje Cmax, menimo, da to zvečanje ni dovolj veliko, da bi kazalo na to, da pride do klinično zaskrbljujočega kopičenja ali prevelike izpostavljenosti, če poskrbimo za širok varnostni razpon za priporočeni interval štirih ur med odmerki.
If you or your carer notice any of the side effects above, call an ambulance straight away.
Če opazite ali če vaš negovalec opazi katerega od navedenih neželenih učinkov, nemudoma pokličite rešilca.
PecFent is not recommended for use in patients who have received monoamine oxidase (MAO) inhibitors within the previous 14 days because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics.
Zdravilo PecFent se ne priporoča pri bolnikih, ki so v zadnjih 14 dneh dobili zaviralce monoaminoksidaze (MAO), saj poročajo o resnih in nepredvidljivih povečanjih učinkov zaviralcev MAO z opioidnimi analgetiki.
As soon as PecFent is no longer needed, patients and members of their household must be advised to systematically dispose of any bottles remaining from a prescription as soon as possible by returning them to their child-resistant container and discarding them, according to local requirements or by returning them to the pharmacy.
Takoj ko zdravila PecFent ne potrebujejo več, naj bolniki in člani njihovih gospodinjstev čim prej dosledno zavržejo vse steklenice, ki so jim še ostale, tako da jih shranijo nazaj v vsebnike z zaporko, varno za otroke, in jih odvržejo v skladu z lokalnimi predpisi ali jih vrnejo v lekarno.
Don't use any other kind of nasal spray for at least 15 minutes after using PecFent.
Ne uporabljajte nobenih drugih pršil za nos vsaj 15 minut po tistem, ko uporabite zdravilo PecFent.
Even if there is little or no medicine left in the bottle, PecFent must be disposed of properly, according to the following steps: o Patients and caregivers must be instructed to properly dispose of all unused, partially used and used PecFent bottles.
Tudi če je v steklenici ostalo malo ali nič zdravila, moramo zdravilo PecFent pravilno odvreči v skladu z naslednjimi koraki: o Bolniki in negovalci morajo biti poučeni o tem, kako se pravilno odvržejo vse neporabljene,
PecFent is used in adults with cancer for a type of pain called ‘breakthrough' pain.
Zdravilo PecFent se uporablja pri odraslih z rakom za vrsto bolečine, ki se imenuje ‘prebijajoča' bolečina.
Treatment of acute pain other than breakthrough pain.
Zdravljenje druge akutne bolečine kot prebijajoče.
Frequently, these will cease or decrease in intensity with continued use of the medicinal product, as the patient is titrated to the most appropriate dose.
Ti neželeni učinki bodo izginili ali se bo njihova intenzivnost zmanjšala pri stalni uporabi zdravila, ko bo bolnik stitriran na najprimernejši odmerek.
Secondary pharmacological effects are respiratory depression, bradycardia, hypothermia, constipation, miosis, physical dependence and euphoria.
Sekundarni farmakološki učinki so depresija dihanja, bradikardija, hipotermija, zaprtost, mioza, telesna odvisnost in evforija.
In a pharmacokinetic study comparing PecFent (100, 200, 400 and 800 micrograms) with oral transmucosal fentanyl citrate (OTFC, 200 micrograms), fentanyl was shown to be rapidly absorbed following single dose intranasal administration of PecFent, with median Tmax ranging from 15 to 21 minutes (Tmax for OTFC was approximately 90 minutes).
V farmakokinetični študiji, v kateri so primerjali zdravilo PecFent (100, 200, 400 in 800 mikrogramov) s peroralnim transmukoznim fentanilcitratom (oral transmucosal fentanyl citrateOTFC, 200 mikrogramov), so pokazali, da se fentanil po enkratni intranazalni aplikaciji zdravila PecFent hitro absorbira, mediani Tmax je med 15 in 21 minutami (Tmax za OTFC je bil približno 90 minut).
• All unused devices or empty containers should be returned systematically according to the local regulation.
• Vse neuporabljene pripomočke ali prazne vsebnike je treba sistematično vrniti v skladu z lokalnimi predpisi.
As with other opioids, in case of insufficient pain control in response to an increased dose of fentanyl, the possibility of opioid-induced hyperalgesia should be considered.
Tako kot pri drugih opioidih, je treba v primeru nezadostnega obvladovanja bolečine v odziv na zvečan odmerek fentanila, upoštevati, da lahko pride do z opioidi sprožene hiperalgezije.
As you repeat step 5, the red bar will become smaller and smaller until you see a green bar in the counting window (Figure 3b-e).
Pri ponavljanju koraka 5 bo rdeči stolpec postajal čedalje manjši, dokler se ne bo v okencu števca pojavil zelen stolpec (slika 3b-e).
Contents of the pack and other information What PecFent contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo PecFent
• When you spray PecFent into your nose the very small spray droplets form a thin gel.
• Ko si razpršite zdravilo PecFent v nos, oblikujejo zelo majhne kapljice pršila redek gel.
Embryo-foetal developmental toxicity studies conducted in rats and rabbits revealed no compoundinduced malformations or developmental variations when administered during the period of organogenesis.
Študije toksičnosti za embriofetalni razvoj, opravljene pri podganah in kuncih, niso pokazale malformacij ali razvojnih variacij, povzročenih z zdravilom, ki so ga dajali med organogenezo.
Patients must be advised that they may not feel the spray being administered, and that they should, therefore, rely on the audible click and the number on the counter advancing to confirm that a spray has been delivered.
Bolnikom morate povedati, da mogoče ne bodo čutili pršenja, zato morajo verjeti slišnemu kliku in zvečanju števila na števcu, ki potrjujeta, da je bil vpih apliciran.
Athletes should be informed that treatment with fentanyl could lead to positive doping tests.
Športnikom morate povedati, da lahko zdravljenje s fentanilom povzroči pozitivne teste na nedovoljena poživila (doping).
After the PecFent bottle has been primed (prepared for use) it delivers 2 full sprays.
Potem ko je bila steklenica z zdravilom PecFent ‘aktivirana' (pripravljena za uporabo), odda 2 polnih vpihov.
o If there are any unwanted therapeutic sprays remaining in the bottle, the patient should be instructed to expel these as follows:
o Če v steklenici ostane kaj neželenih terapevtskih vpihov, je treba bolnika podučiti, naj steklenico izpraznipo naslednjih navodilih:
The plasma protein binding of fentanyl is 80 - 85 %.
80-85 % fentanila se veže na plazemske beljakovine.
• feel very sleepy
• če ste zelo zaspani,
• medicines that might make you sleepy such as sleeping tablets, tranquilisers, muscle relaxants, medicines for anxiety or medicines for allergies (anti-histamines)
• zdravila, zaradi katerih bi lahko bili zaspani, na primer uspavala, pomirjevala, mišične relaksante, zdravila za anksioznost ali zdravila za alergije (antihistaminike);
PecFent can deliver 100, 200, 400 and 800 microgram doses as follows:
Zdravilo PecFent omogoča dajanje odmerkov po 100, 200, 400 in 800 mikrogramov, in sicer:
It is subject to first pass hepatic and intestinal metabolism and the metabolites do not contribute to fentanyl's therapeutic effects.
Izpostavljen je metabolizmu prvega prehoda skozi jetra in črevo, presnovki pa ne prispevajo k terapevtskim učinkom fentanila.
This is because the medicine can get into your breast milk and may cause side effects in the breast-fed child.
Zdravilo namreč lahko pride v vaše mleko in povzroči neželene učinke pri dojenem otroku.
The symptoms of fentanyl overdose via the nasal route are expected to be similar in nature to those of intravenous fentanyl and other opioids, and are an extension of its pharmacological actions, with the most serious significant effect being respiratory depression.
Pričakujemo, da bodo simptomi prevelikega odmerka fentanila po nazalni poti po naravi podobni simptomom prevelikega odmerka intravenskega fentanila in drugih opioidov in da bodo razširitev njegovih farmakoloških učinkov, tako da bo najresnejši pomembni učinek depresija dihanja.
The metabolites are mainly excreted in the urine, while faecal excretion is less important.
Presnovki se v glavnem izločijo z urinom, izločanje z blatom pa je manj pomembno.
If you experience withdrawal symptoms, you should contact your doctor.
Če opazite odtegnitvene simptome, se posvetujte z zdravnikom.
• you have breathing problems such as asthma, wheezing or shortness of breath
• imate težave z dihanjem, na primer astmo, sopenje ali kratko sapo;
• loss of taste, loss or change in sense of smell
• izguba čuta za okus, izguba ali sprememba voha,
May cause allergic reactions (possibly delayed), and exceptionally, bronchospasm (if you do not use the nasal spray correctly).
Lahko povzroča alergijske reakcije (lahko odložene) in izjemoma bronhospazem (če nepravilno uporabljate pršilo za nos).
To prime the bottle, please follow the instructions below:
Steklenico aktivirate tako, da se ravnate po navodilih v nadaljevanju:
Nevertheless, in view of the importance of renal and hepatic function in the metabolism and clearance of fentanyl, additional care should be exercised in the use of PecFent in the elderly.
Kljub temu je glede na pomembnost delovanja ledvic in jeter v presnovi in očistku fentanila pri uporabi zdravila PecFent pri starejših bolnikih potrebna še dodatna skrbnost.
Following long-term treatment, fentanyl may cause withdrawal in the new-born infant.
Po dolgoročnem zdravljenju lahko fentanil pri novorojenčku povzroči odtegnitvene simptome.
[8 spray bottle:] After first-use, use within 60 days
[Steklenica z 8 vpihi:] Porabite v 60 dneh po prvi uporabi.
If this dose is not successful, the patient may be prescribed a bottle of PecFent 400 micrograms/spray and instructed to change to one 400 microgram spray for their next episode of pain.
Če ta odmerek ne zadošča, lahko bolniku predpišemo steklenico zdravila PecFent 400 mikrogramov/vpih in mu naročimo, naj za naslednjo epizodo bolečine uporabi en 400-mikrogramski vpih.
Coma is also known to occur.
da lahko nastopi tudi koma.
In a double-blind, randomized comparator-controlled study (Study 044) of similar design to Study 043 conducted in opioid-tolerant patients with breakthrough cancer pain on stable doses of regularly scheduled opioids, PecFent was shown to be superior to immediate-release morphine sulfate (IRMS).
V dvojno slepi, randomizirani študiji, kontrolirani s primerjalnim zdravilom (študija 044), s podobno zasnovo kot študija 043, opravljeni pri bolnikih, tolerantnih za opioide, s prebijajočo bolečino zaradi raka, na stabilnih, redno razporejenih odmerkih opioidov so pokazali, da je zdravilo PecFent boljše od morfinovega sulfata s takojšnjim sproščanjem (IRMS).
If the spray has not been used within 5 days after priming, the bottle should be discarded.)
Če pršila ne porabite v 5 dneh po aktivaciji, morate steklenico zavreči.)
Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.
Prebijajoča bolečina je prehoden izbruh bolečine, ki se dodatno pojavi ob sicer obvladani dolgotrajni bolečini.
PecFent is only to be used by adults who are already taking other opioid medicines daily for their constant cancer pain.
Zdravilo PecFent naj uporabljajo samo odrasli, ki vsak dan že jemljejo druga opioidna zdravila za stalno bolečino zaradi raka.
Keep out of the sight and reach of children (Figure 6)
Zdravilo shranjujte zunaj dosega in pogleda otrok (slika 6).
• From treatment initiation, patients should be closely followed and the dose titrated until an effective dose is reached and confirmed for two consecutively treated episodes of BTP.
• Od uvedbe zdravljenja naprej moramo bolnike skrbno spremljati in titrirati odmerek, dokler ne dosežemo učinkovitega odmerka in ga ne potrdimo v dveh zaporedno zdravljenih epizodah
• misusing the medicine
• napačna uporaba zdravila,
The effect of renal or hepatic impairment on the pharmacokinetics of PecFent has not been studied.
Učinka okvare ledvic ali jeter na farmakokinetiko zdravila PecFent niso proučevali.
If serotonin syndrome is suspected, treatment with PecFent should be discontinued.
Pri sumu na serotoninski sindrom je treba zdravljenje z zdravilom PecFent prekiniti.
• The pharmacist must inform the patients that in order to prevent theft and misuse of PecFent nasal spray they have to keep it in a safe place to avoid misuse and diversion
• farmacevt mora obvestiti bolnike, da morajo zaradi preprečevanja kraje in nepravilne uporabe pršila nos PecFent to zdravilo hraniti na varnem mestu, da preprečijo nepravilno uporabo in uvedbo zdravila na nezakoniti trg;
Uncommon side effects: (may affect up to 1 in 100 people):
Občasni neželeni učinki (pojavijo se lahko pri do 1 od 100 bolnikov):
The concomitant use of partial opioid agonists/antagonists (e.g. buprenorphine, nalbuphine, pentazocine) is not recommended.
Sočasna uporaba delnih opioidnih agonistov/antagonistov (npr. buprenorfina, nalbufina, pentazocina) ni priporočljiva.
The concomitant use of other central nervous system depressants, including other opioids, sedatives or hypnotics, general anaesthetics, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines and alcohol may produce additive depressant effects.
Sočasna uporaba drugih depresorjev centralnega živčevja, vključno z drugimi opioidi, sedativi ali hipnotiki, splošnimi anestetiki, fenotiazini, pomirjevali, relaksanti skeletnih mišic, sedativnimi antihistaminiki in alkoholom, lahko povzroči dodatne depresorne učinke.
You will hear a second ‘click' and there should now be a single large red bar in the counting window (Figure 3b).
Slišali boste še en ‘klik', v okencu števca pa boste zdaj videli en sam velik rdeč stolpec (slika 3b).
An audible click will be heard and the number displayed on the counter will advance by one.
Zasliši se klik, število, vidno v okencu števca, pa se bo zvečalo za eno.
Although muscle rigidity interfering with respiration has not been seen following the use of PecFent, this is possible with fentanyl and other opioids.
Čeprav po uporabi zdravila PecFent niso ugotavljali rigidnosti mišic, ki bi ovirala dihanje, je to možno pri fentanilu in drugih opioidih.
During the longer-term, open-label study (CP045) this was 6.0 % of 42,227 episodes in 355 patients treated with PecFent during up to 159 days of treatment.
Med dolgoročnejšo odprto študijo (CP045) je to predstavljalo 6,0 % od 42.227 epizod pri 355 bolnikih, zdravljenih z zdravilom PecFent med največ 159 dnevi zdravljenja.
• Do not use for more than 5 days after first use (either priming or using to treat a breakthrough pain episode).
• Zdravila ne uporabljajte več kot 5 dni po prvi uporabi (bodisi aktiviranju bodisi uporabi za blaženje epizode prebijajoče bolečine).
Fentanyl is highly lipophilic and is well distributed beyond the vascular system, with a large apparent volume of distribution.
Fentanil je zelo lipofilen in se dobro porazdeljuje zunaj žilja z velikim navideznim porazdelitvenim volumnom.
• The prescribers of PecFent nasal spray must critically select the patients and closely follow o Instructions for use of the nasal spray device o Instructions for opening and closing of the child-resistant box o Information on the correct indication
• Zdravniki, ki predpisujejo pršilo za nos PecFent, morajo izbirati bolnike po strogih merilih in natančno slediti o navodilom za uporabo pršila za nos; o navodilom za odpiranje in zapiranje vsebnika, varnega za otroke; o informacijam o pravilni indikaciji.
Other medicines and PecFent
Druga zdravila in zdravilo PecFent
• Do not use for more than 60 days after first use (either priming or using to treat a breakthrough pain episode).
• Zdravila ne uporabljajte več kot 60 dni po prvi uporabi (bodisi aktiviranju bodisi uporabi za blaženje epizode prebijajoče bolečine).
• This is a single spray into one nostril from the 100 microgram per spray bottle.
• To je en sam vpih v eno nosnico iz steklenice s 100 mikrogrami na vpih.
• If the spray is blocked, aim the spray away from you (and any other people) and push firmly down on the pump.
• Če je pršilo blokirano, usmerite razpršilno šobo proč od sebe (in drugih ljudi) in čvrsto pritisnite na črpalko.
A new bottle of PecFent will show two red lines in the counting window in the white plastic top on the bottle (Figure 1 and Figure 3a).
Nova steklenica zdravila PecFent ima v okencu števca, ki je v belem plastičnem vrhu steklenice, dve rdeči črtici (sliki 1 in 3a).
fentanyl, oxycodone or hydromorphone) to control your constant background pain.
oksikodon ali hidromorfon) za obvladovanje stalne osnovne bolečine.
Dose-proportionality was demonstrated for Cmax and AUC in the dose range 100 micrograms to 800 micrograms.
Dokazali so sorazmernost odmerku za Cmax in AUC v razponu odmerkov od 100 mikrogramov do 800 mikrogramov.
PecFent is only intended for nasal use, and must not be administered by any other route.
Zdravilo PecFent je namenjeno samo za nazalno uporabo in ga ni dovoljeno uporabljati na noben drug način.
In these patients, opioids may decrease respiratory drive and increase airway resistance.
Pri teh bolnikih lahko opioidi zmanjšajo dihalne spodbude in zvečajo upornost dihalnih poti.
• Patients whose initial dose is 100 micrograms and who need to titrate to a higher dose due to a lack of effect can be instructed to use two 100 microgram sprays (one in each nostril) for their next BTP episode.
• Bolnikom, katerih začetni odmerek je 100 mikrogramov in ki se morajo zaradi pomanjkanja učinka titrirati na večji odmerek, lahko naročimo, naj pri naslednji epizodi BTP uporabijo dva
Finding the right dose
Ugotavljanje pravilnega odmerka
It has been 60 days or more since you primed or used your bottle for the first time.
• je preteklo 60 dni ali več od takrat, ko ste steklenico prvič 'aktivirali' (pripravili za uporabo) ali uporabili.
There was no clinically significant effect of acute rhinitis on Cmax, Tmax or overall exposure to fentanyl, comparing the unchallenged with the acutely challenged states.
Akutni rinitis ni klinično pomembno vplival na Cmax, Tmax ali celotno izpostavljenost fentanilu, če so primerjali neprovocirano stanje z akutno izzvanim stanjem.
The influence of hepatic and renal impairment on the pharmacokinetics of the medicinal product has not been evaluated; however, when administered intravenously the clearance of fentanyl has been shown to be altered in hepatic and renal impairment due to alterations in metabolic clearance and plasma proteins.
Vpliva okvar jeter in ledvic na farmakokinetiko zdravila niso ovrednotili; vendar je dokazano, da se pri okvarah jeter in ledvic pri intravenski uporabi očistek fentanila spremeni zaradi sprememb presnovnega očistka in plazemskih beljakovin.
• you have liver or kidney problems.
• imate težave z jetri ali ledvicami.
If switching to PecFent from another fentanyl product for BTP, independent dose titration with PecFent is required as the bioavailability between products differs significantly.
Če bolnik prehaja na zdravilo PecFent z drugega zdravila s fentanilom za BTP, je potrebna neodvisna titracija odmerka z zdravilom PecFent, ker se biološka uporabnost različnih zdravil pomembno razlikuje.
• get cold clammy skin, look pale, have a weak pulse or other signs of shock.
• če dobite hladno vlažno kožo, postanete bledi, imate šibek srčni utrip ali druge znake šoka.
In severe cases taking too much PecFent may also lead to coma.
V hudih primerih lahko prevelik odmerek zdravila PecFent povzroči tudi komo.
• Do not use PecFent during child birth.
• Ne uporabljajte zdravila PecFent med porodom.
• A dose to treat a breakthrough pain episode might be either 1 spray or 2 sprays (one in each nostril).
• Odmerek za blaženje prebijajoče bolečine je lahko 1 vpih ali 2 vpiha (po eden v vsako nosnico).
• feeling tired or weak, problems moving
• utrujenost ali oslabelost, težave z gibanjem,
• you feel that PecFent is becoming less effective in treating your episodes of breakthrough pain
• imate občutek, da postaja zdravilo PecFent manj učinkovito za zdravljenje obdobij prebijajoče bolečine;
Patients should not use more than 4 doses per day.
Bolniki ne smejo uporabiti več kot 4 odmerke na dan. Bolniki morajo počakati vsaj 4 ure po odmerku,
The variability of the pharmacokinetics of fentanyl was considerable following treatment with both PecFent and OTFC.
Variabilnost farmakokinetike fentanila je bila po zdravljenju tako z zdravilom PecFent kot z OTFC znatna.
PecFent utilises the PecSys nasal drug delivery system to modulate the delivery and absorption of fentanyl.
Zdravilo PecFent uporablja sistem nazalne uporabe zdravila za modulacijo aplikacije in absorpcije fentanila.
Product strength (micrograms)
Jakost zdravila (mikrogrami)
• If you use more PecFent than you should, you may feel sleepy, sick, dizzy or have slow or shallow breathing.
• Če boste uporabili večji odmerek zdravila PecFent, kot bi smeli, boste mogoče zaspani, se boste slabo počutili, boste omotični ali boste počasi ali plitvo dihali.
• nasal sprays to treat a stuffy nose (containing a decongestant such as oxymetazoline)
• pršila za nos za zdravljenje zamašenega nosu (ki vsebujejo dekongestiv, na primer oksimetazolin);