natgillin/translations-raw huggingface dataset:
Initial evaluation of the maximum analgesic effect of DUROGESIC cannot be made before the patch is worn for 24 hours.
Maksimalnega analgetičnega učinka zdravila DUROGESIC ne moremo ovrednotiti, dokler bolnik ne nosi obliža 24 ur.
To prevent overdose it is recommended that opioid-naïve patients receive low doses of immediate-release opioids (eg, morphine, hydromorphone, oxycodone, tramadol, and codeine) that are to be titrated until an analgesic dosage equivalent to DUROGESIC with a release rate of 12 mcg/h or 25 mcg/h is attained.
Da bi preprečili preveliko odmerjanje, je pri bolnikih, ki še niso prejemali opioidov, priporočljivo titrirati odmerek z majhnimi odmerki opioidov s takojšnjim sproščanjem (npr. morfin, hidromorfon, oksikodon, tramadol in kodein), dokler ne dosežemo ekvianalgetičnega odmerka za zdravilo DUROGESIC s stopnjo sproščanja 12 mikrogramov/h ali 25 mikrogramov/h.
Opioids increase the tone and decrease the propulsive contractions of the smooth muscle of the gastrointestinal tract.
Opioidi povečajo tonus in zmanjšajo propulzivna krčenja gladkega mišičja v prebavilih.
Hypoaesthesia, Convulsion (including clonic convulsions and grand mal convulsion), Amnesia, Depressed level of consciousness, Loss of consciousness
(vključno z kloničnimi in konvulzijami grand mal), amnezija, zmanjšana stopnja zavesti, izguba zavesti
In general, the discontinuation of opioid analgesia should be gradual in order to prevent withdrawal symptoms (see section 4.8).
Splošno velja, da mora biti za preprečitev pojava odtegnitvenih simptomov ukinitev opioidne analgezije postopna (glejte poglavje 4.8).
Previous analgesic therapy should therefore be gradually phased out after the initial dose application until analgesic efficacy with DUROGESIC is attained.
Predhodno analgetično terapijo zato ukinjamo postopno, v času od prve uporabe obliža do doseženega analgetičnega učinka z zdravilom DUROGESIC.
• Heart beat feels fast or uneven (palpitations, tachycardia)
• hiter ali nenormalen srčni utrip (palpitacije, tahikardija)
The simulations suggest that the steady-state AUC of patients with Child-Pugh Grade B liver disease (Child-Pugh Score = 8) would be approximately 1.36 times larger compared with that of patients with normal liver function (Grade A; Child-Pugh Score = 5.5).
Simulacije kažejo, da bi bila AUC bolnikov z okvaro jeter Child-Pugh razreda B (stopnja Child-Pugh = 8) v stanju dinamičnega ravnovesja približno 1,36-krat večja v primerjavi z bolniki z normalnim delovanjem jeter (razred A,
It is recommended that DUROGESIC be used in patients who have demonstrated opioid tolerance.
Priporočljivo je, da zdravilo DUROGESIC uporabljajo bolniki, ki so že razvili toleranco na opioide.
• It may take some time for your first patch to have its maximum effect.
• Da začne vaš prvi obliž v celoti delovati, lahko traja nekaj časa.
The effects of the inducer decline gradually and may result in increased fentanyl plasma concentrations, which could increase or prolong both the therapeutic and adverse effects, and may cause serious respiratory depression.
Učinki induktorja postopoma upadajo in lahko povzročijo zvečanje plazemskih koncentracij fentanila, to pa lahko poveča ali podaljša terapevtski učinek in neželene učinke ter povzroči hudo depresijo dihanja.
DUROGESIC may interact with these medicines and you may experience changes to mental status such as feeling agitated, seeing, feeling, hearing, or smelling things that are not there (hallucinations) and other effects such as changing blood pressure, fast heart beat, high body temperature, overactive reflexes, lack of coordination, muscle stiffness, nausea, vomitting and diarrhoea.
Zaradi možnega mesdebojnega delovanja zdravila DUROGESIC in temi zdravili lahko pri vas pride do sprememb duševnega stanja, kot so vznemirjenost, videnje, čutenje, slišanje ali vohanje stvari, ki jih ni (halucinacije) in drugih učinkov, kot so sprememba krvnega tlaka, hiter srčni utrip, visoka telesna temperatura, pretirane refleksne reakcije, pomanjkanje koordinacije, okorelost mišic, slabost, bruhanje in driska.
Data in subjects with cirrhosis and simulated data in subjects with different grades of impaired liver function treated with transdermal fentanyl suggest that fentanyl concentrations may be increased, and fentanyl clearance may be decreased compared to subjects with normal liver function.
Podatki o bolnikih s cirozo in simulirani podatki pri preiskovancih z različnimi stopnjami okvare jeter, zdravljenih s transdermalnim fentanilom, kažejo, da so lahko koncentracije fentanila zvečane, očistek fentanila pa zmanjšan v primerjavi s preiskovanci z normalnim delovanjem jeter.
The appropriate initiating dose of DUROGESIC should be based on the patient's current opioid use.
Primeren začetni odmerek zdravila DUROGESIC mora biti določen na podlagi trenutne uporabe opioidov pri bolniku.
Caution is advised when DUROGESIC is co-administered with medicinal products that affect the serotonergic neurotransmitter systems.
Pri predpisovanju zdravila DUROGESIC sočasno z zdravili, ki vplivajo na serotoninergični nevrotransmiterski sistem, je potrebna previdnost.
• Unusual feeling in the skin, such as tingling or crawling feelings (paraesthesia)
• nenavaden občutek na koži kot je mravljinčenje ali zbadanje (parestezija)
Respiratory depression may persist beyond the removal of the DUROGESIC patch.
Depresija dihanja lahko traja še po odstranitvi transdermalnega obliža DUROGESIC.
• Do not use soap or any other cleansers, creams, moisturisers, oils or talc before applying the patch
• Pred namestitvijo obliža ne uporabljajte mil ali drugih čistilnih sredstev, krem, losijonov, olj ali smukca.
DUROGESIC should be applied to non-irritated and non-irradiated skin on a flat surface of the torso or upper arms.
Transdermalni obliž DUROGESIC je treba prilepiti na nerazdraženo in neobsevano kožo, na ravno površino zgornjega dela trupa ali nadlakti.
Fentanyl is an opioid analgesic, interacting predominantly with the µ opioid receptor.
Mehanizem delovanja Fentanil je opioidni analgetik, ki se veže predvsem na µ-opioidne receptorje.
How to store DUROGESIC Contents of the pack and other information
Shranjevanje zdravila DUROGESIC Vsebina pakiranja in dodatne informacije
Stopping suddenly may make you feel unwell
Če jih boste nenadoma prenehali uporabljati, se boste morda počutili slabo.
The safety profile in children and adolescents treated with DUROGESIC was similar to that observed in adults.
Varnostni profil neželenih učinkov je bil pri otrocih in mladostnikih, ki so prejemali zdravilo DUROGESIC, podoben kot pri odraslih.
• Medicines used to treat HIV infection (such as ritonavir).
• Zdravila za zdravljenje okužbe z virusom HIV (kot je ritonavir).
If you switch from a different painkiller to DUROGESIC or if you suddenly stop using DUROGESIC, you may notice withdrawal effects such as sickness, feeling sick, diarrhoea, anxiety or shivering.
Če boste prešli z drugega protibolečinskega zdravila na zdravilo DUROGESIC ali če nenadoma prenehate uporabljati zdravilo DUROGESIC, boste morda opazili odtegnitvene učinke zdravila, kot so slabost, bruhanje, driska, občutek tesnobe in drgetanje.
Make sure it sticks well, especially the edges
Prepričajte se, da se je obliž dobro prilepil na kožo, zlasti na robovih.
• Itching, skin rash or redness of the skin
• srbenje, kožni izpuščaj ali pordela koža
The concomitant use of CYP3A4 inhibitors and DUROGESIC is not recommended, unless the patient is closely monitored (see section 4.4).
Sočasna uporaba zaviralcev CYP3A4 in zdravila DUROGESIC ni priporočljiva, razen če je bolnik pod skrbnim nadzorom (glejte poglavje 4.4).
• If you forget, change your patch as soon as you remember and make note of the day and time.
Če ste pozabili zamenjati obliž • Če ste pozabili zamenjati obliž, ga zamenjajte takoj, ko se spomnite in si zabeležite dan in čas.
The dosage may subsequently be titrated upwards or downwards, if required, in increments of either 12 or 25 mcg/h to achieve the lowest appropriate dosage of DUROGESIC depending on response and supplementary analgesic requirements.
ZMANJŠAMO, ČE JE POTREBNO, V ODMERKIH PO 12 ALI 25 MIKROGRAMOV/H, DOKLER NE DOSEŽEMO NAJMANJŠEGA PRIMERNEGA ODMERKA ZDRAVILA DUROGESIC, ODVISNO OD BOLNIKOVEGA ODZIVA IN DODATNIH POTREB PO ANALGETIKU.
If the site of DUROGESIC application requires cleansing prior to application of the patch, this should be done with clear water.
Če je treba kožo pred uporabo zdravila DUROGESIC očistiti, to naredimo s čisto vodo.
• Your upper body or arm
• zgornji del telesa ali rame
DUROGESIC should be administered to only those opioid-tolerant paediatric patients (ages 2 to 16 years) who are already receiving at least 30 mg oral morphine equivalents per day.
Zdravilo DUROGESIC se sme uporabiti samo pri pediatričnih bolnikih (starih od 2 do 16 let), ki dobro prenašajo opioide in že prejemajo odmerek opioida, ki ustreza vsaj 30 mg peroralnega morfina/dan.
High inter-subject variability in plasma concentrations has been observed.
Opažali so velike razlike v plazemskih koncentracijah med posamezniki.
DUROGESIC should be used with caution in patients with brain tumours.
Zdravilo DUROGESIC je treba previdno uporabljati tudi pri bolnikih z možganskimi tumorji.
DUROGESIC should not be used during pregnancy unless you have discussed this with your doctor.
Zdravila DUROGESIC ne smete uporabljati med nosečnostjo, razen če ste se o tem pogovorili z zdravnikom.
Therefore, the concomitant use of DUROGESIC and CYP3A4 inhibitors is not recommended unless the benefits outweigh the increased risk of adverse effects.
Sočasna uporaba zdravila DUROGESIC in zaviralcev CYP3A4 ni priporočljiva, razen kadar koristi odtehtajo zvečano tveganje za pojav neželenih učinkov.
Dose titration and maintenance therapy The DUROGESIC patch should be replaced every 72 hours.
Titracija odmerka in vzdrževalno zdravljenje Transdermalni obliž DUROGESIC je treba zamenjati vsakih 72 ur.
The potential for serious or life-threatening hypoventilation exists even if the lowest dose of DUROGESIC is used in initiating therapy in opioid-naïve patients, especially in elderly or patients with hepatic or renal impairment.
Verjetnost za pojav resne ali življenjsko nevarne hipoventilacije obstaja celo pri pri uvajanju zdravila DUROGESIC v najmanjšem odmerku bolnikom, ki še niso jemali opioidov, še posebej starejšim bolnikom in bolnikom z okvaro jeter ali ledvic.
To remove the patch from the protective sachet, locate the pre-cut notch (indicated by an arrow on the patch label) along the edge of the seal.
Za odpiranje vrečice poiščemo zarezo na robu blazinice (označena je s puščico).
1a parenteral buprenorphine sublingual parenteral codeine oral parenteral
1a parenteralna buprenorfin sublingvalna parenteralna kodein peroralna parenteralna
• Let your doctor know this has happened and leave the patch on for another 3 days (72 hours) or as directed by your doctor, before changing the new patch as usual
• Obvestite svojega zdravnika in obliž ponovno zamenjajte po 3 dneh (72 urah) ali kot vam je naročil vaš zdravnik.
A patch accidently sticking to another person (particularly a child) can cause the medicine in the patch to go through the skin of the other person and cause serious side effects such as breathing difficulties, with slow or shallow breathing which may be fatal.
Če se obliž prilepi na drugo osebo (predvsem na otroka), lahko pride do nenamernega vnosa zdravila in do neželenih učinkov, kot so težave z dihanjem (počasno ali plitvo dihanje), ki lahko povzročijo smrt.
You may need to be closely monitored if you are taking some of the types of medicines listed below or if you stop taking some of the types of medicines listed below, as this may affect the strength of DUROGESIC you need.
Če jemljete katero od spodaj naštetih zdravil ali ste katero od njih prenehali jemati, vas bodo morda morali skrbno spremljati, ker lahko vplivajo na jakost zdravila DUROGESIC, ki jo potrebujete.
A patient who is treated with DUROGESIC should wait at least 1 week after removal of the last patch before initiating treatment with a CYP3A4 inhibitor.
DUROGESIC, mora po odstranitvi zadnjega obliža počakati vsaj 1 teden, preden lahko začne zdravljenje z zaviralcem CYP3A4.
Serotonergic medicinal products
Serotoninergična zdravila
Further open the sachet along both sides, folding the sachet open like a book.
Vrečico odpremo kot knjigo po obeh straneh zavarjenega roba.
In two paediatric studies, the required fentanyl transdermal patch dose was calculated conservatively: 30 mg to 44 mg oral morphine per day or its equivalent opioid dose was replaced by one DUROGESIC 12 mcg/h patch.
V dveh pediatričnih študijah je bil ustrezen odmerek transdermalnih obližev s fentanilom preračunan previdno: 30 do 44 mg peroralnega morfina na dan ali enakovreden odmerek opioida so zamenjali z enim transdermalnim obližem DUROGESIC 12,5 mikrogramov/h.
• Feeling of body temperature change
• spremembe telesne telesne temperature
15b methadone oral parenteral
15b metadon peroralna parenteralna
To calculate the appropriate starting dose of DUROGESIC, follow the steps below.
Pri izračunu primernega odmerka zdravila DUROGESIC upoštevajte naslednje korake: 1.
Oral doses are those recommended when changing from a parenteral to an oral route.
Peroralni odmerki so tisti priporočeni, pri zamenjavi parenteralnega s peroralnim načinom zdravljenja.
Very rarely these breathing problems can be life-threatening or even fatal, especially in people who have not used strong opioid painkillers (like DUROGESIC or morphine) before.
Zelo redko so lahko te težave z dihanjem življenjsko nevarne ali celo smrtne, še posebej pri bolnikih, ki še niso uporabljali močnih opioidnih protibolečinskih zdravil (kot je zdravilo
If serotonin syndrome is suspected, treatment with DUROGESIC should be discontinued.
Če obstaja sum za serotoninski sindrom, je potrebno zdravljenje z zdravilom DUROGESIC prekiniti.
Hair at the application site (a non-hairy area is preferable) should be clipped (not shaved) prior to application.
Pred aplikacijo obliža je treba dlake na mestu aplikacije (po možnosti je treba izbrati del kože, kjer ni dlak) porezati (ne obriti).
Extra caution should be used in patients with chronic constipation.
Posebna pozornost je potrebna pri bolnikih s kroničnim zaprtjem.
• Muscle tremors or spasms
• tresenje ali mišični krči
• Flu-like illness
• gripi podobni simptomi
The concomitant use of other central nervous system depressants, (including opioids, sedatives, hypnotics, general anaesthetics, phenothiazines, tranquilizers, sedating antihistamines, and alcoholic beverages) and skeletal muscle relaxants, may produce additive depressant effects; hypoventilation, hypotension, profound sedation, coma or death may occur.
sedativi, hipnotiki, splošnimi anestetiki, fenotiazini, trankvilizanti, sedativnimi antihistaminiki in alhokolnimi pijačami) in relaksanti skeletnih mišic ima lahko dodatne zaviralne učinke; pojavijo se lahko hipoventilacija, hipotenzija, globoka sedacija, koma ali smrt.
How to dispose of used patches or patches you no longer use A used or unused patch accidentally sticking to another person, especially a child, may be fatal.
Uporabljen ali neuporabljen obliž, ki se po nesreči prilepi na drugo osebo, predvsem na otroka, je lahko smrtno nevaren.
3b oxycodone oral parenteral oxymorphone rectal parenteral
3b oksikodon peroralna parenteralna oksimorfon rektalna parenteralna
PHARMACEUTICAL FORM AND CONTENTS Transdermal patch [To be completed nationally]
FARMACEVTSKA OBLIKA IN VSEBINA transdermalni obliž [izpolni država članica]
DUROGESIC and alcohol Do not drink alcohol while using DUROGESIC unless you have talked to your doctor first.
Med zdravljenjem z zdravilom DUROGESIC ne pijte alkohola, razen če ste se pred tem pogovorili s svojim zdravnikom.
Excretion occurs primarily, as metabolites, with less than 10% of the dose excreted as unchanged active substance.
Sekrecija poteka predvsem v obliki presnovkov, manj kot 10% zdravilne učinkovine se izloči nespremenjene.
Caution should be exercised when treating patients with myasthenia gravis.
Pri zdravljenju bolnikov z miastenijo gravis je potrebna previdnost.
Fold the sachet at the notch, then carefully tear the sachet material.
Vrečico prepognemo po zarezi in nato previdno pretrgamo.
DUROGESIC doses should be individualised based upon the status of the patient and should be assessed at regular intervals after application.
Odmerek zdravila DUROGESIC je treba prilagoditi vsakemu bolniku posebej, glede na njegovo stanje, in po namestitvi obliža v rednih intervalih ocenjevati njegovo ustreznost.
• DUROGESIC may make you unusually drowsy, and make your breathing more slow or shallow.
• Zdravilo DUROGESIC lahko povzroči neobičajno zaspanost ter počasnejše ali plitvejše dihanje.
The safety of DUROGESIC was evaluated in 289 paediatric subjects (<18 years) who participated in 3 clinical studies for the management of chronic or continuous pain of malignant or non-malignant origin.
Varnost in učinkovitost zdravila DUROGESIC so ocenili pri 289 pediatričnih preiskovancih (< 18 let), ki so sodelovali v 3 kliničnih študijah obvladovanja kronične ali neprestane bolečine rakavega ali nerakavega izvora.
• Some medicines used to treat cancer of the blood (such as idelalisib).
• Nekatera zdravila za zdravljenje krvnega raka (kot je idelalizib).
To guard against accidental ingestion by children, use caution when choosing the application site for DUROGESIC (see sections 4.2 and 6.6) and monitor adhesion of the patch closely.
Da bi pri otrocih preprečili, da bi po nesreči zaužili zdravilo, je potrebna posebna previdnost pri izbiri mesta namestitve transdermalnega obliža DUROGESIC (glejte poglavji 4.2 in 6.6) ter redno spremljanje prilepljenosti obliža.
DUROGESIC contains a medicine called fentanyl.
Zdravilo DUROGESIC vsebuje zdravilno učinkovino fentanil.
• Feeling sleepy (somnolence)
• zaspanost (somnolenca)
Fentanyl is rapidly distributed to various tissues and organs, as indicated by the large volume of distribution (3 to 10 L/kg after intravenous dosing in patients).
Fentanil se hitro porazdeli med različna tkiva in organe, kar kaže velik volumen porazdelitve (3 do
DUROGESIC may be worn continuously for 72 hours.
Zdravilo DUROGESIC se lahko neprekinjeno nosi 72 ur.
The serum fentanyl concentrations attained are proportional to the DUROGESIC patch size.
Linearnost/nelinearnost Serumske koncentracije fentanila so proporcionalne velikosti transdermalnega obliža DUROGESIC.
1 Conversion to DUROGESIC dosages greater than 25 mcg/h is the same for paediatric patients as it is for adult patients
1 Pretvorba v odgovarjajoči odmerek transdermalnih obližev DUROGESIC pri odmerkih, večjih od 25 mikrogramov/h, je za pediatrične in odrasle bolnike enaka (glejte preglednico 2).
20b ketobemidone oral parenteral levorphanol oral parenteral
20b ketobemidon peroralna parenteralna levorfanol peroralna parenteralna
Data from intravenous studies with fentanyl suggest that elderly patients may have reduced clearance, a prolonged half-life, and they may be more sensitive to the drug than younger patients.
Podatki iz študij z intravensko injiciranim fentanilom kažejo, da imajo starejši bolniki lahko zmanjšan očistek, podaljšan razpolovni čas in so lahko bolj občutljivi na zdravilo v primerjavi z mlajšimi bolniki.
The dose of DUROGESIC may need to be increased or a switch to another analgesic active substance may be needed.
Morda bo treba prilagoditi odmerek zdravila DUROGESIC ali preiti na zdravljenje z drugim analgetikom.
• The patches are waterproof
• Obliži so odporni na vodo.
Within 72 hours of IV fentanyl administration, approximately 75% of the dose is excreted into the urine and approximately 9% of the dose into the faeces.
injiciranju fentanila, se približno 75 % odmerka fentanila izloči z urinom in približno 9 % z blatom.
• Medicines used to treat an irregular heart beat (such as amiodarone, diltiazem, or verapamil).
• Zdravila za zdravljenje nepravilnega srčnega utripa (kot so amiodaron, diltiazem ali verapamil).
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using DUROGESIC.
Če karkoli od naštetega velja za vas (ali niste prepričani), se pred uporabo zdravila DUROGESIC
DUROGESIC with antidepressants
Zdravilo DUROGESIC skupaj z antidepresivi
There is a high inter-subject variability in fentanyl pharmacokinetics, in the relationships between fentanyl concentrations, therapeutic and adverse effects, and in opioid tolerance.
V farmakokinetiki fentanila, v razmerju med koncentracijami fentanila ter terapevtskimi in neželenimi učinki in v toleranci na opioide so velike razlike med preiskovanci.
• Some medicines used to treat epilepsy (such as carbamazepine, phenobarbital, or phenytoin).
• Nekatera zdravilaza zdravljenje epilepsije (kot so karbamazepin, fenobarbital ali fenitoin).
The resultant prolongation in gastrointestinal transit time may be responsible for the constipating effect of fentanyl.
Posledično se gastrointestinalni čas prehoda podaljša, kar je lahko vzrok za zaprtje zaradi fentanila.
Patients should be advised on measures to prevent constipation and prophylactic laxative use should be considered.
Bolnikom je treba svetovati, kako preprečiti zaprtje; premisliti pa je potrebno tudi o preventivni uporabi odvajal.
If you are not sure, talk to your doctor or pharmacist before using DUROGESIC.
Če niste prepričani, se pred uporabo zdravila DUROGESIC posvetujte z zdravnikom ali farmacevtom.
Do not sunbathe, have long hot baths or saunas or use hot whirlpool spa baths.
Ne izpostavljajte se sončenju, dolgotrajnim vročim kopelim ali savnam in ne uporabljajte vročih termalnih masažnih bazenov.
Therefore after a dose increase, patients should wear the higher dose patch through two 72-hour applications before any further increase in dose level is made.
Zato mora bolnik pred morebitnim naslednjim povečanjem odmerka obliž uporabljati dve 72-urni obdobji.
There have been reports of patches accidentally sticking to a family member while in close physical contact or sharing the same bed as the person wearing the patch.
Znano je nekaj primerov, ko se je obliž ob tesnem stiku po nesreči prilepil na družinskega člana pri souporabi postelje.
Other medicines and DUROGESIC
Druga zdravila in zdravilo DUROGESIC
It is recommended that DUROGESIC is used in patients who have demonstrated opioid tolerance (see section 4.2).
Zdravilo DUROGESIC je priporočljivo uporabljati pri bolnikih, ki so že razvili toleranco na opioide (glejte poglavje 4.2).
In a study conducted with DUROGESIC, healthy elderly subjects had fentanyl pharmacokinetics which did not differ significantly from healthy young subjects although peak serum concentrations tended to be lower and mean half-life values were prolonged to approximately 34 hours.
Študija zdravila DUROGESIC je pokazala, da v farmakokinetiki fentanila pri zdravih starejših in zdravih mlajših preiskovancih ni statistično značilnih razlik, kljub temu, da so največje serumske koncentracije fentanila pri starejših manjše in povprečni razpolovni čas podaljšan na približno 34 ur.
Follow the advice above and keep the person who was wearing the patch moving and talking as much as possible.
Bolnik, ki je uporabljal obliž naj se ves čas premika in čimveč govori.
• Medicines for relaxing your muscles (such as cyclobenzaprine or diazepam).
• Zdravila za sproščanje mišic (kot sta cikobenzaprin ali diazepam).
Starting dosages of 25 mcg/h and higher were used by the remaining 179 subjects, 174 (97.2%) of whom had been on opioid doses of at least 45 mg of oral morphine equivalents per day.
Ostalih 179 preiskovancev je prejemalo začetne odmerke 25 mikrogramov/h ali večje, 174 (97,2 %) jih je predhodno prejemalo odmerek opioida, ki ustreza vsaj 45 mg peroralnega morfina na dan. Izmed ostalih 5 preiskovancev z začetnim odmerkom vsaj 25