natgillin/translations-raw huggingface dataset:
All patients should be advised to avoid exposing the DUROGESIC application site to direct external heat sources such as heating pads, electric blankets, heated water beds, heat or tanning lamps, sunbathing, hot water bottles, prolonged hot baths, saunas and hot whirlpool spa baths.
Bolnikom je treba naročiti, naj mesta aplikacije zdravila DUROGESIC ne izpostavljajo direktnim zunanjim virom toplote (grelne blazine, električne odeje, ogrevane vodne postelje, toplotne luči ali luči za umetno porjavitev, sončenje, termoforji, dolgotrajne vroče kopeli, savna, vroče masažne kopeli).
(frequency cannot be estimated from the available data.)
To so lahko znaki hude alergijske reakcije (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov.
1 In clinical studies these ranges of daily oral morphine doses were used as a basis for conversion to DUROGESIC.
1 V kliničnih študijah so uporabili zgoraj navedene dnevne peroralne odmerke morfina kot osnovo za pretvorbo v odgovarjajoči odmerek zdravila DUROGESIC.
Make certain that the edges of the patch are adhering properly.
Preverimo, da so tudi robovi obliža dobro prilepljeni.
• Medicines used to treat fungal infection (such as itraconazole, ketoconazole, fluconazole, or voriconazole).
• Zdravila za zdravljenje glivičnih okužb (kot so itrakonazol, ketokonazol, flukonazol ali vorikonazol).
Elderly patients should be observed carefully and the dose should be individualised based upon the status of the patient (see sections 4.4 and 5.2).
Starejše bolnike je treba skrbno spremljati in odmerek glede na status prilagoditi vsakemu bolniku posebej (glejte poglavji 4.4 in 5.2).
In opioid-naïve elderly patients, treatment should only be considered if the benefits outweigh the risks.
O zdravljenju starejših bolnikov, ki opioidov še niso uporabljali, se sme razmisliti le, kadar prednosti zdravljenja odtehtajo tveganja.
Fentanyl, a high clearance active substance, is rapidly and extensively metabolised mainly by CYP3A4.
Fentanil je zdravilo z visokim očistkom, ki se hitro in obsežno presnavlja zlasti preko encima CYP3A4.
Breastfeeding should therefore be discontinued during treatment with DUROGESIC and for at least 72 hours after removal of the patch.
Med zdravljenjem z zdravilom Durogesic in vsaj še 72 ur po odstranitvi obliža je dojenje potrebno prekiniti.
If concomitant use of DUROGESIC with a CYP3A4 inhibitor cannot be avoided, close monitoring for signs or symptoms of increased or prolonged therapeutic effects and adverse effects of fentanyl (in particular respiratory depression) is warranted, and the DUROGESIC dosage must be reduced or interrupted as deemed necessary (see section 4.5).
CYP3A4 ne moremo izogniti, je treba biti posebej pozoren na znake ali simptome povečanega ali podaljšanega terapevtskega učinka in pojava neželenih učinkov fentanila (predvsem na depresijo dihanja), odmerek zdravila DUROGESIC pa po potrebi zmanjšati ali pa zdravljenje prekiniti (glejte poglavje 4.5)
2 In clinical studies these ranges of daily oral morphine doses were used as a basis for conversion to DUROGESIC.
2 V kliničnih študijah so uporabili zgoraj navedene dnevne peroralne odmerke morfina kot osnovo za pretvorbo v odgovarjajoči odmerek transdermalnih obližev DUROGESIC.
Fentanyl is a high clearance active substance and is rapidly and extensively metabolised primarily by CYP3A4 in the liver.
Fentanil ima velik očistek, se hitro in obsežno presnavlja v jetrih, predvsem s CYP3A4.
It may take 20 hours or more for the fentanyl serum concentrations to decrease 50%.
Za zmanjšanje serumske koncentracije fentanila za 50% je potrebno 20 ur ali več.
Patches should be inspected prior to use.
• Obliž je treba pred uporabo pregledati glede morebitne poškodbe.
DUROGESIC may have more severe adverse effects in patients with chronic obstructive or other pulmonary disease.
Kronična bolezen pljuč Neželeni učinki zdravila DUROGESIC pri bolnikih s kronično obstruktivno pljučno boleznijo ali drugimi boleznimi pljuč so lahko resnejši.
PHARMACEUTICAL FORM Transdermal patch.
FARMACEVTSKA OBLIKA transdermalni obliž
• Feeling agitated or disoriented
• občutek razdraženosti ali disorientiranosti
Then they should be safely discarded by putting them back into the original sachet and stored out of sight and reach of other people, especially children, until safely disposed.
Nato jih morate dati v njihovo originalno vrečico in jih hraniti nedosegljivo drugim ljudem, predvsem otrokom, dokler jih ne boste na varen način zavrgli.
Cases of serious respiratory depression after coadministration of CYP3A4 inhibitors with transdermal fentanyl have been reported, including a fatal case after coadministration with a moderate CYP3A4 inhibitor.
Po sočasni uporabi zaviralcev CYP3A4 in transdermalnega fentanila so poročali so o primerih resne depresije dihanja, vključno s smrtnim primerom po sočasni uporabi z zmernimi zaviralci CYP3A4.
nausea (35.7%), vomiting (23.2%), constipation (23.1%), somnolence (15.0%), dizziness (13.1%), and headache (11.8%).
Na osnovi združenih podatkov o varnosti iz teh kliničnih študij so bili najpogosteje poročani neželeni učinki (tj. pojavnost ≥ 10 %): navzea (35,7 %), bruhanje (23,2 %), zaprtje (23,1 %), somnolenca (15,0%), omotica (13,1 %) in glavobol (11,8 %).
• Keep used patches out of sight and reach of children - even used patches contain some medicine which may harm children and may even be fatal
• Tudi uporabljeni obliži vsebujejo nekaj zdravila, ki lahko škoduje otrokom, in lahko povzročijo tudi smrt.
In opioid-naïve patients with renal or hepatic impairment, treatment should only be considered if the benefits outweigh the risks.
O zdravljenju bolnikov z okvaro ledvic ali jeter, ki opioidov še niso uporabljali, se sme razmisliti le, kadar prednosti zdravljenja odtehtajo tveganja.
The concomitant use of DUROGESIC with cytochrome P450 3A4 (CYP3A4) inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong both the therapeutic and adverse effects, and may cause serious respiratory depression.
Sočasna uporaba zdravila DUROGESIC in zaviralcev citokroma P450 3A4 (CYP3A4) lahko povzroči večje plazemske koncentracije fentanila, kar lahko poveča ali podaljša terapevtski učinek fentanila in neželene učinke ter povzroči resno depresijo dihanja.
Patients with renal or hepatic impairment should be observed carefully and the dose should be individualised based upon the status of the patient (see sections 4.4 and 5.2).
Bolnike z okvaro ledvic ali jeter je treba skrbno spremljati, odmerek pa glede na status prilagoditi vsakemu bolniku posebej (glejte poglavi 4.4 in 5.2).
Agitation, Disorientation, Euphoric mood
depresija, anksioznost, stanje zmedenosti, halucinacije agitacija, dezorientiranost, evforično razpoloženje
The interval between IV antagonist doses should be carefully chosen because of the possibility of re-narcotization after the patch is removed; repeated administration or a continuous infusion of naloxone may be necessary.
Presledek med odmerki intravenskega antagonista je treba skrbno izbrati, ker obstaja možnost renarkotizacije po odstranitvi obliža.
6b fentanyl oral parenteral hydromorphone oral parenteral
6b fentanil peroralna parenteralna hidromorfon peroralna parenteralna
How to use DUROGESIC
Kako uporabljati zdravilo DUROGESIC
A lag time of 12 to 24 hours after application of the first patch and after a dose increase must be taken into account.
Po aplikaciji prvega obliža in po zvečanju odmerka je treba upoštevati 12- do 24-urni čas do nastopa polnega učinka.
After coadministration of weak, moderate or strong CYP3A4 inhibitors with short term intravenous fentanyl administration, decreases in fentanyl clearance were generally ≤25%,
Po sočasnem dajanju šibkih, zmernih ali močnih zaviralcev CYP3A4 in kratkotrajne uporabe fentanila se je očistek fentanila na splošno zmanjšal za ≤ 25%, z ritonavirjem (močen zaviralec CYP3A4) pa se je očistek fentanila v povprečju zmanjšal za 67%.
Additional restrictions apply to opioid-naïve patients with renal impairment (see section 4.2).
Dodatne omejitve je treba upoštevati pri bolnikih z okvaro ledvic, ki še niso prejemali opioidov (glejte poglavje 4.2).
Step 5: Wash • Always wash your hands after you have handled the patch using clean water only
• Roke si vedno umijte s čisto vodo.
In case the patch sticks to the skin of another person, take the patch off right away and get medical attention.
V takem primeru je potrebno obliž takoj odstraniti s kože in poiskati medicinsko pomoč.
• Medicines for helping you sleep (such as temazepam, zaleplon, or zolpidem).
• Zdravila za zdravljenje težav sspanjem (temazepam, zaleplon ali zolpidem).
Musculoskeletal and connective tissue disorders
Bolezni mišično skeletnega sistema in vezivnega tkiva mišični krči trzanje mišic
• Excessive sweating
• čezmerno potenje
• Talk to your doctor before you stop using these patches
Če želite prenehati uporabljati obliže • Pogovorite se s svjim zdravnikom, preden prenehate uporabljati te obliže.
Patients may require periodic supplemental doses of a short acting analgesic for “breakthrough” pain.
Lahko se zgodi, da bodo bolniki za lajšanje prebijajoče bolečine potrebovali dodatni kratkodelujoči analgetik.
There have been very rare reports of newborn infants experiencing neonatal withdrawal syndrome when mothers chronically used DUROGESIC during pregnancy (see section 4.6).
Če so matere med nosečnostjo dolgo časa jemale zdravilo DUROGESIC, so pri novorojencih zelo redko poročali o odtegnitvenem sindromu (glejte poglavje 4.6).
DUROGESIC Dosage (mcg/h)
Odmerek zdravila DUROGESIC (mikrogrami/h)
Table 2: Recommended starting dosage of DUROGESIC based upon daily oral morphine dose (for patients who have a need for opioid rotation or for clinically less stable patients: conversion ratio of oral morphine to transdermal fentanyl is approximately equal to 150:1) 1
Preglednica 2: Priporočeni začetni odmerek zdravila DUROGESIC, glede na dnevni peroralni odmerek morfina (za bolnike, pri katerih je potrebno menjavanje opioidov ali za klinično manj stabilne bolnike: pretvorbeno razmerje peroralnega morfina v transdermalni fentanil je približno 150:1) 1
• Press this sticky part of the patch onto the skin
• To lepljivo stran obliža pritisnite na kožo.
In the circumstance in which commencing with oral opioids is not considered possible and DUROGESIC is considered to be the only appropriate treatment option for opioid-naïve patients, only the lowest starting dose (ie, 12 mcg/h) should be considered.
Kadar ocenimo, da pri bolnikih, ki še niso prejemali opioidov, uvedba peroralnih opioidov ni možna in je za zdravljenje primerno le zdravilo DUROGESIC, ga je treba uvesti z najmanjšim odmerkom (to je 12 mikrogramov/h).
If you do, you may increase the amount of medicine you get from the patch.
To lahko zveča količino zdravila, ki se sprosti iz obliža.
The concomitant use of transdermal fentanyl with CYP3A4 inducers may result in a decrease in fentanyl plasma concentrations and a decreased therapeutic effect.
Sočasna uporaba transdermalnega fentanila in induktorjev CYP3A4 lahko povzroči zmanjšanje plazemske koncentracije fentanila in terapevtskega učinka.
As a result of continued absorption of fentanyl from the skin depot after removal of the patch, the half-life of fentanyl after transdermal administration is about 2- to 3-fold longer than intravenous administration.
Zaradi kontinuirane absorbcije fentanila skozi depo v koži je po odstranitvi obliža razpolovni čas fentanila (transdermalna uporaba) okrog 2
Among the remaining 5 subjects with a starting dosage of at least 25 mcg/h whose prior opioid doses were <45 mg of oral morphine equivalents per day, 1 (0.6%) had previously been receiving <30 mg of oral morphine equivalents per day and 4 (2.2%) had been receiving 30 to 44 mg of oral morphine equivalents per day (see section 4.8).
mikrogramov/h, ki so predhodno prejemali odmerek opioida, ki ustreza < 45 mg peroralnega morfina na dan, je 1 (0,6%) predhodno prejemal odmerek opioida, ki ustreza < 30 mg peroralnega morfina na dan, 4 (2,2%) pa so prejemali odmerek opioida, ki ustreza 30 do 40 mg peroralnega morfina na dan (glejte poglavje 4.8).
Tell your doctor if you notice any of these effects.
Če opazite katerega koli izmed teh učinkov, se posvetujte z zdravnikom.
Pharmacodynamic-related interactions
Interakcije, povezane s farmakokinetiko
Table 5: Adverse reactions in adult and paediatric patients System/organ class
Neželeni učinki pri odraslih in pediatričnih bolnikih
b Based on single-dose studies in which an IM dose of each active substance listed was compared with morphine to establish the relative potency.
b Na osnovi študij z enkratnim odmerkom, pri katerih so primerjali i.m.
Equianalgesic potency conversion In patients currently taking opioid analgesics, the starting dose of DUROGESIC should be based on the daily dose of the prior opioid.
Pri bolnikih, ki že prejemajo opioidne analgetike, mora začetni odmerek zdravila DUROGESIC temeljiti na dnevnem odmerku opioida, ki ga je bolnik prejemal pred tem.
Concomitant use of mixed opioid agonists/antagonists The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended.
Sočasna uporaba buprenorfina, nalbufina ali pentazocina ni priporočljiva.
• If your patches keep falling off, talk to your doctor, pharmacist or nurse
• Če se vam obliži vedno znova odlepijo, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
However, as the influence of renal impairment on the pharmacokinetics of fentanyl has not been evaluated, caution is advised (see sections 4.2 and 4.4).
Ker pa vpliva okvare ledvic na farmakokinetiko fentanila niso ocenili, je priporočljiva previdnost (glejte poglavje
Erectile dysfunction, Sexual dysfunction
Motnje reprodukcije in dojk motnje erekcije, motnje v spolnosti
The development of a potentially life-threatening serotonin syndrome may occur with the concomitant use of serotonergic active substances such as Selective Serotonin Re-uptake Inhibitors (SSRIs) and Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs), and with active substances which impair metabolism of serotonin (including Monoamine Oxidase Inhibitors [MAOIs]).
Pri sočasni uporabi serotoninergičnih zdravil, kot so selektivni zaviralci privzema serotonina (SSRISelective Serotonin Re-uptake Inhibitors), zaviralci privzema serotonina-noradrenalina (SNRISerotonin Norepinephrine Re-uptake Inhibitors) in zdravil, ki vplivajo na presnovo serotonina (vključno z zaviralci monoaminooksidaze (MAO)), se lahko pojavi potencialno življenjsko nevaren serotoninski sindrom.
Because fentanyl is metabolised to inactive metabolites in the liver, hepatic impairment might delay its elimination.
Fentanil se v jetrih presnovi v v neaktivne presnovke, zato lahko okvara jeter upočasni njegovo odstranjevanje.
DUROGESIC provides continuous systemic delivery of fentanyl during the 72-hour application period.
Zdravilo DUROGESIC zagotavlja 72-urno kontinuirano sistemsko preskrbo s fentanilom.
Dosage titration should normally be performed in 12 mcg/h or 25 mcg/h increments, although the supplementary analgesic requirements (oral morphine 45/90 mg/day ≈ DUROGESIC 12/25 mcg/h) and pain status of the patient should be taken into account.
Navadno je treba odmerek prilagajati v korakih po 12 mikrogramov/h ali 25 mikrogramov/h, vseeno pa moramo upoštevati dodatne potrebe po analgetikih (peroralni morfin
• Some medicines used to treat heartburn or ulcers (such as cimetidine).
• Nekatera zdravila za zdravljenje zgage ali razjed (kot je cimetidin).
Respiratory depression
Depresija dihanja
Diarrhoea, Dry mouth,
Bolezni prebavil navzea, bruhanje, zaprtje driska, suha usta,
(Uncommon, this may affect up to 1 in 100 people)
(občasni, pojavijo se lahko pri največ 1 od 100 bolnikov)
Your doctor will decide which strength of DUROGESIC is most suitable for you, taking into account the severity of your pain, your general condition and type of pain treatment that you have received so far.
Zdravnik vam bo na osnovi ocene vaše bolečine, splošnega zdravstvenega stanja in dosedanjega protibolečinskega zdravljenja predpisal za vas najprimernejšo jakost zdravila DUROGESIC.
Rare side effects (may affect up to 1 in 1000 people)
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov)
Do not use DUROGESIC if you are breastfeeding.
Zdravila DUROGESIC ne smete uporabljati med dojenjem.
If patients with renal impairment receive DUROGESIC, they should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary.
Če bolniki z okvaro ledvic prejemajo zdravilo DUROGESIC, jih je treba skrbno opazovati glede znakov toksičnih učinkov fentanila in po potrebi zmanjšati odmerek.
Therefore, patients with fever should be monitored for opioid undesirable effects and the DUROGESIC dose should be adjusted if necessary.
Bolnike s zvišano telesno temperaturo je treba skrbno spremljati glede pojava neželenih učinkov opioidov in po potrebi prilagoditi odmerek zdravila DUROGESIC.
You should not breastfeed for 3 days after removing your DUROGESIC patch.
Dojiti ne smete še 3 dni po odstranitvi obliža.
Concomitant use of mixed opioid agonists/antagonists The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended (see also section 4.5).
Sočasna uporaba buprenorfina, nalbufina ali pentazocina ni priporočljiva (glejte poglavje 4.5).
Table 1: Conversion Table - Multiplication Factors for Converting the Daily Dose of Prior Opioids to the Equianalgesic 24-hour Oral Morphine Dose (mg/day Prior Opioid x Factor = Equianalgesic 24-hour Oral Morphine Dose) Prior Opioid
Preglednica 1: Pretvorbena preglednica - multiplikator pretvorbe dnevnega odmerka predhodnega opioida v 24-urni ekvianalgetični odmerek morfina
Used patches should be folded firmly in half so that the sticky side of the patch sticks to itself.
Uporabljene obliže morate prepogniti na pol, z lepljivima stranema skupaj.
DUROGESIC can make you drowsy or breathe more slowly.
Zaradi uporabe zdravila DUROGESIC ste lahko omotični ali počasneje dihate.
More about using DUROGESIC
Več o uporabi transdermalnih obližev DUROGESIC
No risk was identified in the paediatric population beyond that expected with the use of opioids for the relief of pain associated with serious illness and there does not appear to be any paediatric-specific risk associated with DUROGESIC use in children as young as 2 years old when used as directed.
Razen pričakovanega tveganja ob uporabi opioidov za lajšanje bolečin, povezanih z resno boleznijo, v pediatrični populaciji niso opazili nobenega drugega tveganja.
• Never divide or cut the patch
• Obliža ne smete razrezati ali razpoloviti.
UNIQUE IDENTIFIER - 2D BARCODE <Not applicable>
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA
Examples of active substance that may decrease fentanyl plasma concentrations include: carbamazepine, phenobarbital, phenytoin and rifampicin (this list is not exhaustive).
karbamazepin, fenobarbital, fenitoin in rimfapicin (ta seznam ni popoln).
The adverse reactions reported with the use of DUROGESIC from these clinical studies, including the above-mentioned adverse reactions, and from post-marketing experiences are listed below in Table 5.
V preglednici 5 so, vključno z zgornjimi, navedeni neželeni učinki, o katerih so poročali v kliničnih študijah in v obdobju trženja zdravila DUROGESIC.
More than one DUROGESIC patch may be used for doses greater than 100 mcg/h.
Pri odmerkih večjih od 100 mikrogramov/h lahko uporabljamo več obližev hkrati.
• If you have any further questions, ask your doctor, pharmacist or nurse
- Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
What DUROGESIC looks like and contents of the pack [To be completed nationally]
Zdravilo DUROGESIC vsebuje {ime pomožne(ih) snovi} [To be completed nationally]
Elderly patients should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary (see section 4.4).
Starejše bolnike je treba skrbno opazovati glede znakov toksičnosti fentanila in po potrebi zmanjšati odmerek (glejte poglavje 4.4).
If a patch falls off
Če se vam obliž odlepi
Several days should elapse before a new patch is applied to the same area of the skin.
Šele po nekaj dneh lahko zopet damo obliž na isto mesto.
When you are wearing the patch do not expose it to direct heat such as heating pads, electric blankets, hot-water bottles, heated water beds or heat or tanning lamps.
Med uporabo, obliža ne izpostavljajte neposrednemu viru toplote, kot so grelne blazine, električne odeje, termoforji, ogrevane vodne postelje, toplotne luči ali luči za umetno porjavitev.
DUROGESIC should be administered only to opioid-tolerant children age 2 years or older (see section 4.2).
Zdravilo DUROGESIC lahko prejemajo samo otroci, stari 2 leti ali več, pri katerih se je že razvila toleranca na opioide (glejte poglavje 4.2).
To derive the DUROGESIC dosage corresponding to the calculated 24-hour, equianalgesic morphine dosage, use dosage-conversion Table 2 or 3 as follows: a. Table 2 is for adult patients who have a need for opioid rotation or who are less clinically stable (conversion ratio of oral morphine to transdermal fentanyl approximately equal to b. Table 3 is for adult patients who are on a stable, and well-tolerated, opioid regimen (conversion ratio of oral morphine to transdermal fentanyl approximately equal to 100:1).
Za pretvorbo 24-urnega ekvianalgetičnega odmerka morfina v ustrezni odmerek zdravila Durogesic uporabite preglednico 2 ali 3 kot sledi: a. Preglednica 2 je namenjena odraslim bolnikom, pri katerih je potrebno menjavanje opioidov ali za klinično manj stabilne bolnike (razmerje za pretvorbo peroralnega morfina v transdermalni fentanil je približno 150:1).
CYP3A4 Inducers
Induktorji CYP3A4
It belongs to a group of strong painkillers called opioids.
Fentanil uvrščamo v skupino močnih protibolečinskih učinkovin, ki jih imenujemo opioidi.
hydroxyzine, or lorazepam) and medicines for mental conditions (anti-psychotics, such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
• Zdravila, ki seuporabljajo za pomiritev (pomirjevala, kot so alprazolam, klonazepam, diazepam, hidroksizin ali lorazepam) in zdravila za zdravljenje duševnih motenj (antipsihotiki, kot so aripiprazol, haloperidol, olanzapin, risperidon ali fenotiazin).
• Some medicines used to treat depression or Parkinson's disease called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine).You should not take DUROGESIC
• Nekatera zdravila, ke se uporabljajo za zdravljenje depresije ali Parkinsonove bolezni, imenovana zaviralci MAO (kot so izokarboksazid, fenelzin, selegilin ali tranilcipromin).
What you need to know before you use DUROGESIC
Kaj morate vedeti, preden boste uporabili zdravilo DUROGESIC Ne uporabljajte zdravila DUROGESIC
If you, or your partner or carer, notice that the person wearing the patch is unusually drowsy, with slow or shallow breathing: - Take the patch off - Call a doctor, or go to your nearest hospital straight away - Keep the person moving and talking as much as possible
Če vi, vaš partner ali negovalec opazite, da je oseba, ki nosi obliž neobičajno zaspana ter počasneje ali bolj plitvo diha:
Anaphylactic reaction, Anaphylactoid reaction
anafilaktična reakcija, anafilaktoidn a reakcija
Contents of the pack and other information What DUROGESIC contains [To be completed nationally]
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo DUROGESIC
Tolerance, physical dependence, and psychological dependence can develop on repeated use of DUROGESIC (see section 4.4).
Pri dolgotrajni uporabi zdravila DURIGESIC se lahko pojavijo toleranca, fizična in psihična odvisnost (glejte poglavje 4.4).
• Constricted pupils (miosis)
• zožanje zenic (mioza)
Therefore, the product information of the CYP3A4 inhibitor must be consulted for the active substance's half-life and duration of the inhibitory effect before applying the first DUROGESIC patch.
Zato je treba pred prvo namestitvijo transdermalnega obliža DUROGESIC prebrati informacije o zdravilu zaviralca CYP3A4 glede razpolovnega časa ter čas trajanja zaviranja.
• Headache
• driska
Abdominal pain, Abdominal pain upper, Dyspepsia
bolečine v trebuhu, bolečine v zgornjem delu trebuha, dispepsija ileus subileus