FrancophonIA/ELRC3.0 huggingface dataset:
English: Furthermore, a study at the highest dose (100 µg/h) would be possible only in intensive care units and under concomitant treatment with opioid antagonists (naltrexone) in order to avoid life threatening side effects.
Slovenian: Nadalje bi bila študija z največjimi odmerki (100 µg/h) možna le v oddelkih za intenzivno nego in pri sočasnem zdravljenju z opioidnimi antagonisti (naltreksonom), da bi tako preprečili življenjsko nevarne stranske učinke.
English: The most serious undesirable effect of fentanyl is respiratory depression.
Slovenian: Najresnejši neželeni učinek fentanila je respiratorna depresija.
English: WARNING:
Slovenian: OPOZORILO:
English: Not known (cannot be estimated from the available data): Long-term use of fentanyl can lead to development of tolerance and physical and psychological dependence.
Slovenian: Neznano (iz obstoječih podatkov ni mogoče ovrednotiti): Pri dolgotrajni uporabi fentanila se lahko razvijejo toleranca, telesna in psihična odvisnost.
English: - A fentanyl transdermal patch is usually used for 72 hours (3 days).
Slovenian: - Transdermalni obliž se ponavadi uporablja 72 ur (tri dni).
English: If analgesia is insufficient at the end of the initial application period, the dose may be increased after 3 days, until the desired effect is obtained for each patient.
Slovenian: Če je analgetični učinek ob koncu začetnega obdobja uporabe neustrezen, lahko odmerek povečujete v tridnevnih presledkih, dokler ne dosežete želenega učinka.
English: The major metabolite, norfentanyl, is inactive.
Slovenian: Glavni presnovek, norfentanil, je neaktiven.
English: Physical dependence may develop as well and you might experience withdrawal symptoms, if you do suddenly stop using the patches.
Slovenian: Lahko se pojavi tudi fizična odvisnost in odtegnitveni simptomi, če nenadoma prenehate uporabljati obliže.
English: Inform your doctor if you develop a fever during the treatment, as the increased body temperature may cause too much medicine to pass through the skin.
Slovenian: Svojega zdravnika obvestite, če se med zdravljenjem pri vas pojavi vročina, ker lahko zvišana telesna temperatura povzroči pospešeno prehajanje zdravila skozi kožo.
English: The following frequencies are used for the description of the occurrence of adverse reactions: Very common (≥1/10), Common (≥1/100, <1/10), Uncommon (≥1/1000, <1/100), Rare (≥1/10,000, <1/1000), Very rare (<1/10,000)
Slovenian: Opis neželenih učinkov temelji na naslednjih podatkih o pogostosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100, < 1/10), občasni (≥ 1/1.000, < 1/100), redki (≥ 1/10.000, < 1/1.000), zelo redki (< 1/10.000).
English: It is allowed to stay outside in the sun, but you must protect the patch with some piece of clothing during hot summer days.
Slovenian: Dovoljeno je, da ste izpostavljeni soncu, vendar je potrebno v vročih poletnih dneh obliž pred soncem zavarovati s kosom obleke.
English: Because of the importance of an adequate pain management for the mother, the CHMP agrees, in accordance with the “guideline on summary of product characteristics”, that the proposed text stays in section 4.6 and should not be included as a contra-indication.
Slovenian: Z ozirom na pomembnost ustreznega obvladovanja bolečin pri materah se CHMP strinja, v skladu s „smernico o povzetku glavnih značilnosti zdravila“, da predlagano besedilo ostane v poglavju 4.6 in se ne vključi kot kontraindikacija.
English: Austria ratiopharm
Slovenian: Avstrija ratiopharm
English: In such cases increased care and observation of the patient should be undertaken.
Slovenian: V teh primerih je potrebna večja skrb in natančno spremljanje bolnika.
English: - In children, the upper back is the preferred location to apply the patch, to minimize the potential of the child removing the patch.
Slovenian: - Pri otrocih je zgornji del hrbta najprimernejše mesto namestitve, da zmanjšamo možnost, da ga otroci odstranijo sami.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ali ste pred kratkim jemali katero koli zdravilo tudi, če ste ga dobili brez recepta.
English: The product should be used only as part of an integrated treatment of pain in cases where the patient is adequately assessed medically, socially and psychologically.
Slovenian: Zdravilo uporabite le v sklopu zdravljenja bolečine pri bolnikih, ki so ustrezno medicinsko, socialno in psihološko oskrbljeni.
English: Symptoms are that the person breathes abnormally slowly or weakly.
Slovenian: Simptomi so, da bolnik diha počasi in plitvo.
English: Oral morphine dose (mg/24 h)
Slovenian: Peroralni odmerek morfina (mg/24h)
English: The infusion rate should be adjusted according to previous bolus injections and the individual response of the patient.
Slovenian: Hitrost infuzije prilagodite predhodnim bolusnim injekcijam in odzivu posameznega bolnika.
English: Finally, since Fentanyl ratiopharm is a matrix patch for which the release is proportional to the surface area, dose proportionality is expected and a bioequivalence study with the highest strength is not deemed necessary, nor an additional replicate design study.
Slovenian: Končno je glede na dejstvo, da je zdravilo Fentanyl ratiopharm obliž matriksnega tipa, pri katerem je sproščanje sorazmerno površini, sorazmernost odmerka pričakovana, bioekvivalenčna študija z največjo jakostjo pa ni bila ocenjena za potrebno, kakor tudi ne dodatna študija s ponovitvami.
English: The biostatistical evaluation of the existing single dose study with replicate design (but showing nonbioequivalence) could be considered suitable to evaluate intra-individual variability and to determine the influence of the biopharmaceutical performance, in relation to the different release mechanisms (reservoir versus matrix).
Slovenian: Biostatistično vrednotenje obstoječe študije z enkratnimi odmerki na podlagi ponovitvenega načrta (ki pa izkazuje neobstoj bioekvivalence) lahko velja kot primerno za ovrednotenje intraindividualne variabilnosti ter za določitev vpliva biofarmacevtske učinkovitosti v odvisnosti od različnih mehanizmov sproščanja (obliž z rezervoarjem v primerjavi z matriksnim tipom).
English: The demonstration of bioequivalence with the lowest strength was questioned, as in the results, a higher initial input is suggested for the reference reservoir patch (comparatively to the test patch) and a lower final input (at the end of the patch application) is evidenced.
Slovenian: Dokazovanje bioekvivalentnosti z najmanjšo jakostjo je bilo postavljeno pod vprašaj, saj je v rezultatih za referenčni obliž z rezervoarjem priporočen večji začetni vnos (v primerjavi s testnim obližem), ugotovljen pa je nižji končni vnos (ob koncu aplikacije obliža).
English: Common less than 1 in 10, but more than 1 in 100 patients Uncommon less than 1 in 100, but more than 1 in 1000 patients Rare less than 1 in 1000, but more than 1 in 10,000 patients Very rare less than 1 in 10,000 patients, including isolated reports
Slovenian: Pri vrednotenju neželenih učinkov se običajno uporabljajo naslednja merila za njihovo pogostnost: zelo pogosti več kot 1 od 10 bolnikov pogosti manj kot 1 od 10, vendar več kot 1 od 100 bolnikov občasni manj kot 1 od 100, vendar več kot 1 od 1.000 bolnikov redki manj kot 1 od 1.000, vendar več kot 1 od 10.000 bolnikov zelo redki manj kot 1 od 10.000 bolnikov, vključno s posameznimi primeri
English: Therefore, patients should consult their physician as to whether driving or use of machines is permitted.
Slovenian: Bolniki naj se o tem, ali smejo voziti in upravljati stroje, posvetujejo z zdravnikom.
English: Respiratory depression due to overdose can persist longer than the effect of the opioid antagonist.
Slovenian: Respiratorna depresija, ki je posledica prevelikega odmerka, lahko traja dlje od učinka antagonista opioidov.
English: - Acute or postoperative pain, since dosage titration is not possible during short-term use.
Slovenian: - Akutna ali pooperativna bolečina, ker pri kratkotrajni uporabi ni možno prilagoditi odmerka.
English: The most common sign of overdose is reduced ability to breathe.
Slovenian: Najpomembnejši znak prevelikega odmerjanja je omejena sposobnost dihanja.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Slovenian: Eksperimentalne študije na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Caution should therefore be taken in treatment of patients with hypotension and/or patients with hypovolemia.
Slovenian: Zato morate biti pri zdravljenju bolnikov s hipotenzijo in/ali pri hipovolemičnih bolnikih previdni.
English: The transdermal patch should not be cut, since no information is available on the quality, efficacy and safety of such divided patches.
Slovenian: Transdermalnih obližev ne smete razrezati, ker podatkov o kvaliteti, učinkovitosti in varnosti tako deljenih obližev ni.
English: Using Fentanyl-ratiopharm with food and drink
Slovenian: Uporaba obližev Fentanyl-ratiopharm skupaj s hrano in pijačo
English: For the same reason you should avoid exposing the patch on the skin to direct heat such as electric blankets, hot-water bottles, sauna, solarium or hot baths.
Slovenian: Zato se morate tudi izogibati izpostavljanju obližev izvorom direktne toplote kot npr. električnim odejam, termoforjem, savni, solarijem ali vročim kopelim.
English: The effect is reached within 24 hours after the first patch has been applied and its effects fall gradually after the patch is removed.
Slovenian: Učinek se doseže v roku 24 ur po namestitvi prvega obliža, po odstranitvi pa postopoma izzveni.
English: If higher dosages than 500 mg morphine-equivalent are needed, a reassessment of opioid-therapy is recommended.
Slovenian: V primeru potrebe odmerkov višjih od ekvivalenta 500 mg morfina je potrebno zdravljenje z opioidi ponovno ovrednotiti.
English: Animal studies have shown reduced fertility and increased mortality in rat foetuses.
Slovenian: Študije na živalih (podganah) so pokazale zmanjšano plodnost in povečano embrionalno mortaliteto.
English: In this context, the CHMP accepted the indication “Severe chronic pain which can be adequately managed only with opioid analgesics”.
Slovenian: V tem smislu je CHMP sprejel indikacijo „Huda kronična bolečina, ki jo je mogoče ustrezno obvladati le z opioidnimi analgetiki“.
English: Do not discontinue treatment without consulting your doctor.
Slovenian: Ne odstranjujte obližev brez posveta z vašim zdravnikom.
English: Distribution The plasma protein binding for fentanyl is 84 %.
Slovenian: Porazdelitev: Vezava fentanila na plazemske beljakovine je 84-odstotna.
English: Opioids may cause hypotension, especially in patients with hypovolemia.
Slovenian: Opioidi lahko povzročijo hipotenzijo, zlasti pri hipovolemičnih bolnikih.
English: - Severe impairment of the central nervous system.
Slovenian: - Hudo okvarjeno delovanje osrednjega živčevja.
English: High quantities of fentanyl remain in the transdermal patches even after use.
Slovenian: Visoke količine fentanila ostajajo v transdermalnih obližih tudi po uporabi.
English: - the scope of the referral was the potential public health concerns regarding the extension of the clinical indication - the demonstration of the bioequivalence with the reference product, - and the harmonisation of the Summary of Product Characteristics, labelling and package leaflet,
Slovenian: - predmet napotitve so bili potencialni zadržki v zvezi z javnim zdravjem, povezani z razširitvijo klinične indikacije, - dokazovanje bioekvivalence z referenčnim izdelkom, - in usklajevanje povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo,
English: Pharmacotherapeutic group: opioids; Phenylpiperidine derivatives, ATC code: N02AB03
Slovenian: Farmakoterapevtska skupina: opioidni analgetik, derivati fenipiperidina, oznaka ATC: N02AB03
English: If intravenous administration is impossible, naloxone hydrochloride can also be given intramuscularly or subcutaneously.
Slovenian: Če intravenska uporaba ni mogoča, lahko dajete nalokson klorid tudi intramuskularno ali subkutano.
English: However sometimes you may still need extra painkillers.
Slovenian: V določenih primerih pa boste morda dodatna protibolečinska zdravila še vedno potrebovali.
English: - The patch application site should not be exposed to heat from external heat sources (see “Take special care with Fentanyl-ratiopharm”).
Slovenian: - Mesto namestitve obliže ne smete izpostavljati izvoru zunanje toplote (glejte poglavje “Posebna opozorila za uporabo obližev Fentanyl-ratiopharm”).
English: The patch should be changed after 72 hours.
Slovenian: Obliž moramo zamenjati po 72 urah.
English: Fentanyl is an opioid analgesic which interacts predominantly with the µ-receptor.
Slovenian: Fentanil je opioidni analgetik, ki pretežno interagira z µ-receptorji.
English: Your doctor will decide which strength of Fentanyl-ratiopharm is most suitable for you.
Slovenian: Vaš zdravnik bo odločil kateri odmerek zdravila Fentanyl-ratiopharm je za vas najustreznejši.
English: Do not store above 25 °C.
Slovenian: Shranjujte pri temperaturi do 25°C.
English: Regarding the co-administration with other opioids, it is acknowledged that the risk of combining fentanyl with a mixed agonist/antagonist, like buprenorphine, nalbuphine and pentazocine, consists first in impaired analgesia, due to competitive antagonistic effects, and secondly in the onset of a withdrawal syndrome, which also represents a serious health concern.
Slovenian: Glede sočasne uporabe z drugimi opioidi je potrjeno, da so tveganja, povezana s kombiniranjem fentanila z mešanimi agonisti/antagonisti, kot so buprenorfin, nalbufin in pentazocin, prvič okrnjena analgezija zaradi kompetitivnega antagonističnega učinka in drugič pojav odtegnitvenega sindroma, ki ravno tako predstavlja resen zdravstveni pomislek.
English: Fentanyl-ratiopharm has major influence on the ability to drive and use machines.
Slovenian: Fentanyl-ratiopharm ima pomemben vpliv na sposobnost za vožnjo in upravljanje strojev.
English: The analgesic effect may persist for some time after removal of the transdermal patch.
Slovenian: Analgetični učinek lahko traja še nekaj časa po odstranitvi obliža.
English: If an earlier change becomes necessary in individual cases, no change should be made before 48 hours have elapsed, otherwise a rise in mean fentanyl concentrations may occur.
Slovenian: Če je v posameznih primerih potrebna predhodna zamenjava, jo opravimo šele po 48 urah in ne prej, ker sicer lahko pride do dviga srednje koncentracije fentanila.
English: The small differences observed are not deemed to be of clinical importance and suggests that Fentanyl ratiopharm has a somewhat more pronounced prolonged release profile, which is as expected for a matrix patch in comparison with a reservoir patch.
Slovenian: Za majhne opažene razlike je bilo ocenjeno, da niso klinično pomembne in nakazujejo, da ima zdravilo Fentanyl ratiopharm nekoliko bolj izražen profil podaljšanega sproščanja, kar je skladno s pričakovanji za obliž matriksnega tipa v primerjavi z obližem z rezervoarjem.
English: Besides controversial literature results on the efficacy and safety of fentanyl transdermal in chronic non cancer pain, the CHMP recognised that, in special circumstances, strong opioids could be of help for the treatment of this condition.
Slovenian: Ne glede na nasprotujoče si rezultate iz literature glede učinkovitosti in varnosti transdermalnega fentanila pri kronični nerakavi bolečini je CHMP priznal, da utegnejo biti močni opioidi, v posebnih okoliščinah, koristni pri zdravljenju tega stanja.
English: Use in elderly patients Elderly should be observed carefully and the dose reduced if necessary (see sections 4.4 and 5.2).
Slovenian: Uporaba pri starejših Starejše bolnike je treba skrbno opazovati in odmerek po potrebi zmanjšati (glejte poglavje 4.4 in 5.2).
English: This has to be expected especially at the beginning of treatment, at any change of dosage as well as in connection with alcohol or tranquilizers.
Slovenian: Ta učinek lahko pričakujemo predvsem na začetku zdravljenja, ob spremembah odmerkov ter ob uživanju alkohola in jemanju uspaval.
English: SPECIAL STORAGE CONDITIONS Do not store above 25 °C.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 25 °C.
English: This means that it is possible to give the product to nursing mothers, but breast-feeding has to be discontinued during the use of fentanyl patches and 72 hours thereafter.
Slovenian: To pomeni, da je zdravilo mogoče dati doječim materam, vendar pa morajo le-te med uporabo obližev s fentanilom in 72 ur po njej dojenje prekiniti.
English: Therefore, the CHMP recommends that, according to the above mentioned guideline, this aspect should be mentioned in section 4.5 of the SPC with cross reference to section 4.4 “concomitant use not recommended” rather than a contra-indication.
Slovenian: Posledično CHMP priporoča, da je treba ta vidik, v skladu z zgoraj omenjeno smernico, omeniti v poglavju 4.5 povzetka glavnih značilnosti zdravila s sklicevanjem na poglavje 4.4 „sočasna uporaba ni priporočljiva“ namesto kot kontraindikacijo.
English: Tables 2 and 3 should not be used to switch from transdermal fentanyl to a morphine treatment.
Slovenian: Podatkov iz preglednice 2 in 3 ne smemo uporabiti za prehod zdravljenja s transdermalnih obližev na zdravljenje z morfinom.
English: However, this is rarely seen during treatment of pain due to cancer.
Slovenian: To se pri zdravljenju bolečine pri bolnikih z rakom le redko zgodi.
English: Regarding the therapeutic indication, the MAH has provided a scientific statement, which summarises the publications related to the treatment of chronic non cancer pain with strong opioids and particularly transdermal fentanyl.
Slovenian: V zvezi s terapevtsko indikacijo je imetnik dovoljenja za promet z zdravilom predložil znanstveno izjavo, ki predstavlja povzetek publikacij v zvezi z zdravljenjem kronične nerakave bolečine z močnimi opioidi in še posebej s transdermalnim fentanilom.
English: Prior to application, the skin should be carefully washed with clean water (no cleaning agents) and thoroughly dried.
Slovenian: Pred uporabo obliža morate kožo umiti le s čisto vodo (brez katerih koli čistilnih sredstev) in jo osušiti.
English: Reversing the narcotic effect can give rise to acute pain and release of catecholamines.
Slovenian: Ob koncu narkotičnega učinka se lahko pojavita akutna bolečina in sproščanje kateholaminov.
English: There is also no clinical data available which demonstrates withdrawal symptoms in patients treated with transdermal fentanyl after injection of buprenorphine.
Slovenian: Ravno tako ni na voljo kliničnih podatkov, ki bi dokazovali odtegnitvene simptome pri bolnikih, zdravljenih s transdermalnim fentanilom, po injiciranju buprenorfina.
English: [See Annex I - To be completed nationally]
Slovenian: [Glejte dodatek I - Izpolni država članica]
English: However, from the clinical point of view, this aspect represents only a minor risk for patients receiving transdermal fentanyl pain therapy in average doses.
Slovenian: Vendar pa predstavlja ta vidik s kliničnega stališča le manjše tveganje za bolnike, ki prejemajo protibolečinsko zdravljenje na osnovi transdermalnega fentanila v povprečnih odmerkih.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: In case of withdrawal symptoms it is recommended to treat those with short-acting morphine in low doses.
Slovenian: V primeru pojava simptomov odtegnitve je priporočljivo le te zdraviti s kratkotrajno delujočim morfinom v nizkih odmerkih.
English: When treatment with Fentanyl-ratiopharm is withdrawn, serum fentanyl concentrations decline gradually, falling approximately 50 % in 13-22 hours in adults or 22-25 hours in children, respectively.
Slovenian: Po prenehanju zdravljenja z obliži Fentanyl-ratiopharm se koncentracija fentanila v serumu postopoma manjša ter na približno 50 % pade v 13 do 22 urah pri odraslih in v 22 do 25 urah pri otrocih.
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte s svojim zdravnikom ali farmacevtom.
English: The concomitant use of barbituric acid derivatives should be avoided, since the respiratory depressing effect of fentanyl may be increased.
Slovenian: Sočasni uporabi derivatov barbituratne kisline se moramo izogibati, ker lahko poveča učinek respiratorne depresije fentanila.
English: Any breast milk produced during treatment or within 72 hours after the removal of the last patch should be discarded.
Slovenian: Materino mleko med zdravljenjem ali pridobljeno prej kot 72 ur po zadnji odstranitvi transdermalnih obližev je potrebno zavreči.
English: If you are an elderly patient or if you are in a very bad physical condition (cachectic) your doctor will monitor you more carefully, because it may be necessary to prescribe a lower dose.
Slovenian: Če ste starejši bolnik ali ste v slabi telesni kondiciji (slaboten) vas mora vaš zdravnik skrbno nadzorovati.
English: Pharmacokinetics in special groups
Slovenian: Farmakokinetika pri posebnih skupinah bolnikov
English: Patches with a release rate of 12.5 micrograms/hour are available and are appropriate for dose titration in the lower dosage area.
Slovenian: Obliži s hitrostjo sproščanja 12,5 mikrogramov/h, ki so na voljo, so primerni za prilagajanje odmerka v območju nizkih odmerkov.
English: In these cases, it would be preferable to initiate a treatment with low doses of immediate release morphine and to prescribe Fentanyl-ratiopharm after determination of the optimal dosage.
Slovenian: V teh primerih je zdravljenje bolje začeti z nizkimi odmerki morfina s takojšnjim sproščanjem in predpisati zdravljenje z obliži Fentanylratiopharm po določitvi optimalnega odmerka.
English: In patients with renal or hepatic impairment, clearance of fentanyl may be altered because of changes of plasma proteins and metabolic clearance resulting in increased serum concentrations.
Slovenian: Pri bolnikih z boleznijo ledvic ali jeter je lahko očistek fentanila spremenjen zaradi sprememb plazemskih proteinov in izločanja, kar povzroči povečano koncentracijo v serumu.
English: Other undesirable effects
Slovenian: Drugi neželeni učinki
English: The points of disagreement leading to this referral procedure under Article 29(4) of Directive 2001/83/EC pertained to: 1- The therapeutic indication to be extended to non-cancer patients suffering of severe chronic pain 2- The choice of conversion tables(s) to be included in the SPC 3- Whether breast-feeding and co-administration with partial agonist opioids should be contraindicated 4- The bioequivalence studies needed to demonstrate the equivalence with the reference product
Slovenian: Nesoglasja, ki so privedla do tega napotitvenega postopka v skladu s členom 29(4) Direktive 2001/83/ES, zadevajo: 1- terapevtsko indikacijo, ki bi naj bila razširjena na nerakave bolnike s hudo kronično bolečino 2- izbor tabel za prehod z drugih analgetikov, ki bi naj bile vključene v povzetek glavnih značilnosti zdravila 3- vprašanje, ali naj bosta dojenje in sočasna uporaba z delnimi opioidnimi agonisti kontraindicirana 4- bioekvivalenčne študije, potrebne za dokazovanje ekvivalentnosti z referenčnim izdelkom.
English: Additional dose adjustment should normally be performed in 25 micrograms/hour increments, although the supplementary analgesic requirements and pain status of the patient should be taken into account.
Slovenian: Odmerek se običajno povečuje v presledkih po 25 mikrogramov/uro, vendar morate pri tem upoštevati bolnikove potrebe po dodatnih zdravilih in stopnjo bolečine.