FrancophonIA/ELRC3.0 huggingface dataset:
English: Data from intravenous studies with fentanyl suggest that the elderly patients may have reduced clearance and a prolonged half-life.
Slovenian: Podatki iz študij z intravensko uporabljenim fentanilom kažejo, da je pri starejših bolnikih očistek zmanjšan in razpolovni čas izločanja povečan ter, da so ti bolniki občutljivejši na zdravilo kot mlajši bolniki.
English: What Fentanyl-ratiopharm looks like and contents of the pack Fentanyl-ratiopharm is a transparent, transdermal patch with a sticky back so that it can be stuck onto the skin.
Slovenian: Obliži Fentanyl-ratiopharm so prozorni transdermalni obliži z lepljivim hrbtiščem, ki ga lahko prilepimo na kožo.
English: Intensive care unit treatment is important, if required by the patient's clinical condition.
Slovenian: Če to zahteva klinično stanje bolnika, je potrebno zdravljenje v enoti za intenzivno nego.
English: Immune system disorders Very rare:
Slovenian: otekanje in občutek hlajenja Bolezni imunskega sistema Zelo redki:
English: The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended (see also section
Slovenian: Sočasna uporaba buprenorfina, nalbufina ali pentazocina ni priporočljiva (glejte poglavje 4.5).
English: xerostomia, dyspepsia.
Slovenian: dispneja, hipoventilacija
English: Patients receiving opioid treatment for the first time Patches with a release rate of 12.5 micrograms/hour are available and should be used for initial dosing.
Slovenian: Za prvo zdravljenje uporabite obliže s hitrostjo sproščanja 12,5 mirkogramov/h, ki so na voljo.
English: amblyopia.
Slovenian: ambliopija
English: Do not use Fentanyl-ratiopharm after the expiry date which is stated on the package.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
English: The required fentanyl dosage is adjusted individually and should be assessed regularly after each administration.
Slovenian: Odmerek fentanila prilagodite posameznim bolnikom in po vsaki uporabi ovrednotite njegov učinek.
English: EXPIRY DATE
Slovenian: Datum ura
English: After switching from previously prescribed opioid analgesics to Fentanyl-ratiopharm or after abrupt discontinuation of therapy patients may show opioid withdrawal symptoms (for instance: nausea, vomiting, diarrhoea, anxiety and shivering).
Slovenian: Pri nekaterih bolnikih, ki z drugega opioidnega analgetika preidejo na obliže Fentanyl-ratiopharm, se lahko pojavijo reakcije, značilne za prekinitev zdravljenja z opioidi (npr. slabost, bruhanje, driska, tesnoba in mišični tremor).
English: Skin and subcutaneous tissue disorders Very common: sweating, pruritus.
Slovenian: bolečine v sečnem mehurju, oligurija Bolezni kože in podkožja Zelo pogosti: potenje, pruritus Pogosti:
English: If progressive dose increases are made, the active surface area required may reach a point where no further increase is possible.
Slovenian: Če postopoma povečujete odmerek lahko pride do tega, da zmanjka prostora na koži za namestitve nadaljnjih obližev.
English: - if your central nervous system is severely impaired, for instance by brain injury.
Slovenian: - če imate hudo okvarjeno delovanje osrednjega živčevja.
English: Patients may require periodic supplemental doses of a short-acting analgesic for breakthrough pain.
Slovenian: Pri nekaterih bolnikih bo v primeru t. i. "preboja bolečine", morda potreben analgetik s kratkim delovanjem.
English: • the current general condition, the medical status of the patient, and
Slovenian: Upoštevati moramo: - možnost razvoja tolerance - splošno in zdravstveno stanje bolnika in - stopnjo prizadetosti zaradi bolezni
English: The CHMP considers that the criteria of the guideline on transdermal dosage formsCPMP/EWP/280/96- (i.e. exact proportionality of the formulation and acceptable in vitro release test) were met with the fentanyl ratiopharm transdermal patch as well as with the reference medicinal product.
Slovenian: eksaktna sorazmernost formulacije in sprejemljiv test sproščanja in vitro) izpolnjeni tako pri transdermalnem obližu fentanyl ratiopharm, kakor tudi pri referenčnem zdravilu.
English: Adhesive layer
Slovenian: Transdermalni obliž
English: The incidence of respiratory depression increases as the fentanyl dose is increased.
Slovenian: Incidenca tega učinka se povečuje z odmerkom.
English: Fentanyl-ratio 100µg/h, dispositif transdermique The Netherlands Fentanyl ratiopharm 100, pleister voor transdermaal gebruik 100 µg/uur United Kingdom Ribofen 100 microgram/hr Transdermal patch
Slovenian: Fentanyl ratiopharm 100, pleister voor transdermaal gebruik 100 µg/uur Velika Britanija Ribofen 100 microgram/hr Transdermal patch
English: If severe or persistent hypotension occurs, hypovolemia should be considered, and the condition should be managed with appropriate parenteral fluid therapy.
Slovenian: Če se pojavi hujša ali dolgotrajna hipotenzija, bodite pripravljeni na možnost hipovolemije.
English: Rash, erythema and pruritus will usually disappear within one day after the patch has been removed.
Slovenian: izpuščaji, eritem Izpuščaji, eritem in pruritus v 24 urah po odstranitvi transdermalnega obliža običajno izginejo.
English: Morphine
Slovenian: anafilaksija
English: The initial evaluation of the maximum analgesic effect of Fentanyl-ratiopharm should not be made before the patch has been worn for 24 hours.
Slovenian: Največjega analgetičnega učinka transdermalnih obližev Fentanyl-ratiopharm ni mogoče ovrednotiti, dokler ni transdermalni obliž nameščen 24 ur, ker serumska koncentracija fentanila po namestitvi obliža v obdobju 24 ur postopoma narašča.
English: A period of 7 days should be allowed to elapse before applying a new patch to the same area of skin.
Slovenian: Isti predel kože lahko znova uporabite šele po 7-dnevnem premoru.
English: Therefore patients who develop fever should be monitored for opioid adverse reactions.
Slovenian: Zato bodite pri bolnikih, ki imajo zvišano telesno temperaturo, še posebej pozorni na pojav neželenih učinkov opioidov.
English: If discontinuation of the patch is necessary, any replacement with other opioids should be gradual, starting at a low dose and increasing slowly.
Slovenian: Prehod na drugo zdravljenje ali prenehanje zdravljenja Kadar je treba zdravljenje z obliži prekiniti, se priporoča postopna zamenjava z drugimi opioidi z nizkimi začetnimi odmerki in počasnim povečevanjem le teh. Koncentracija fentanila po odstranitvi obliža postopno upada.
English: - As the transdermal patch is protected by an outer waterproof backing film, it can also be worn while showering.
Slovenian: - Transdermalni obliž je na zunanji strani zaščiten z vodotesno folijo, zato ga lahko nosite tudi med prhanjem.
English: To remove hair, scissors should be used instead of razors.
Slovenian: Pred pritrditvijo obliža morate dlake na mestu uporabe postriči (ne obriti).
English: As the transdermal patch is protected by an outer waterproof backing film, it can also be worn while showering.
Slovenian: Transdermalni obliž je na zunanji strani zaščiten z vodotesno folijo, zato ga bolnik lahko nosi tudi med prhanjem.
English: Continued absorption of fentanyl from the skin accounts for a slower reduction in serum concentration than is seen after an intravenous infusion.
Slovenian: Počasnejše upadanje serumske koncentracije kot po intravenski infuziji lahko razložimo z neprekinjeno absorpcijo fentanila skozi kožo.
English: Used transdermal patches should be folded with the adhesive surfaces inwards and discarded or whenever possible returned to the pharmacy.
Slovenian: - Uporabljene transdermalne obliže zvijte skupaj, tako da se lepljive površine dotikajo, shranite jih v zunanjo ovojnino in jih odstranite na ustrezen način ali če je mogoče vrnite vašemu farmacevtu.
English: Intramuscular administration will give a more prolonged effect than intravenous administration.
Slovenian: Učinek po intramuskularnem odmerku traja dlje kot po intravenskem.
English: The transdermal patch is then applied using slight pressure with the palm of the hand for approximately 30 seconds.
Slovenian: Po odstranitvi zaščitne plasti ga položite na želeno mesto in ga z dlanjo držite v takem položaju približno 30 sekund.
English: [20 transdermal patches:] Date
Slovenian: [20 transdermalnih obližev:] Datum ura
English: Oxymorphine 1
Slovenian: Morfin Hidromorfin Oksikodon Metadon Levorfanol Oksimorfin
English: Equianalgesic doses (mg)
Slovenian: Odmerki z enakim analgetičnim učinkom (mg)
English: [5 transdermal patches:] Date
Slovenian: [5 transdermalnih obližev:] Datum ura
English: Fentanyl-ratiopharm should not be used in this population.
Slovenian: Obližev Fentanyl-ratiopharm pri otrocih ne uporabljajte.
English: - Fold the used patch in half so that the sticky edges adhere to each other.
Slovenian: Uporabljene transdermalne obliže zvijte skupaj, tako da se lepljive površine dotikajo.
English: How to store Fentanyl-ratiopharm Further information
Slovenian: Shranjevanje zdravila Fentanyl-ratiopharm Dodatne informacije
English: Fentanyl-ratio 75 µg/h, dispositif transdermique The Netherlands Fentanyl ratiopharm 75, pleister voor transdermaal gebruik 75 µg/uur United Kingdom Ribofen 75 microgram/hr Transdermal patch
Slovenian: Fentanyl ratiopharm 75, pleister voor transdermaal gebruik 75 µg/uur Velika Britanija Ribofen 75 microgram/hr Transdermal patch
English: Additional or alternative methods of analgesia or alternative administration of opioids should be considered when the Fentanyl-ratiopharm dose exceeds 300 micrograms/hour.
Slovenian: Če z odmerkom 300 mikrogramov/uro obližev Fentanyl-ratiopharm ne dosežete zadovoljivega učinka, pretehtajte možnost uporabe dodatnega opioida ali alternativnega načina dajanja zdravila.
English: Excipients:
Slovenian: Izločanje:
English: Itching will usually disappear within one day after the patch has been removed.
Slovenian: Srbenje ponavadi preneha dan po odstranitvi obliža.
English: An exception can be made if the doctor has expressly prescribed Fentanyl-ratiopharm.
Slovenian: Izjema je le, če je zdravilo izredno predpisal zdravnik.
English: The obtained sum should be converted to correspond the oral morphine dosage using Table 1.
Slovenian: S preglednico 1 pretvorite skupno količino v ustrezni peroralni odmerek morfina.
English: Very common: sweating, pruritus.
Slovenian: Zelo pogosti: navzea, bruhanje, zaprtje Pogosti:
English: In chronic non-cancer pain, it might be preferable to initiate the treatment with immediate-release strong opoids (e.g. morphine) and to prescribe fentanyl transdermal patch after determination of the efficacy and the optimal dosage of the strong opioid.
Slovenian: Za začetno zdravljenje kroničnih bolečin, ki niso povezane z rakavimi obolenji, so močni opioidi (npr. morfin) s takojšnjim sproščanjem morda primernejši.
English: DATE OF REVISION OF THE TEXT {MM/YYYY} [To be completed nationally]
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA [Izpolni država članica]
English: If you have been using Fentanyl-ratiopharm for some time, it might happen that Fentanyl-ratiopharm will become less effective for you so that a dose adjustment will be necessary (tolerance may develop).
Slovenian: Pri dolgotrajni uporabi obližev Fentanyl-ratiopharm se lahko zgodi, da bodo obliži Fentanylratiopharm postali manj učinkoviti.
English: Codeine
Slovenian: aritmija
English: The conservative conversion scheme (150:1) as specified in the present SPC of Fentanyl ratiopharm for patient who have a need for opioid rotation and the conversion scheme 100:1 (Donner's table) for patients under stable and well -tolerated opioid therapy.
Slovenian: Glede shem za odmerjanje za prehod z drugih analgetikov, ki so na voljo v povzetku glavnih značilnosti zdravila za prehod s peroralnega morfina na transdermalni fentanil je CHMP na podlagi razpoložljivih podatkov izoblikoval mnenje, da je treba v povzetku glavnih značilnosti zdravila (tabela 4.2) navesti obe tabeli: konzervativno shemo za prehod (150:1), navedeno v obstoječem povzetku glavnih značilnosti zdravila za zdravilo Fentanyl ratiopharm za bolnike, ki potrebujejo rotacijo opioidov, ter shemo za prehod 100:1 (Donnerjevo tabelo) za bolnike s stabilnim zdravljenjem z opioidi, ki ga bolniki dobro prenašajo.
English: Blue printing ink
Slovenian: Zaščitna obloga polipropilenska folija modro črnilo za tisk
English: Before starting to use Fentanyl-ratiopharm you should inform your doctor if you suffer from any of the below disorders, because the risk of side effects is higher and/or your doctor may need to prescribe a lower dose of fentanyl.
Slovenian: Uporabe obližev Fentanyl-ratiopharm ne prekinjajte samostojno, brez posveta s svojim zdravnikom, ker je tveganje za pojav odtegnitvenih znakov večje, če z uporabo obližev nenadoma prekinete.
English: Fentanyl-ratio 25 µg/h, dispositif transdermique The Netherlands Fentanyl ratiopharm 25, pleister voor transdermaal gebruik 25 µg/uur United Kingdom Ribofen 25 microgram/hr Transdermal patch
Slovenian: Fentanyl ratiopharm 25, pleister voor transdermaal gebruik 25 µg/uur Velika Britanija Ribofen 25 microgram/hr Transdermal patch
English: Using other medicines
Slovenian: Medsebojno učinkovanje z drugim zdravili
English: [10 transdermal patches:] Date
Slovenian: [10 transdermalnih obližev:] Datum ura
English: 50 µg/h transdermal patch transdermal use 8.25 mg/15 cm² which release 50 µg fentanyl per hour
Slovenian: 50 µg/h, dispositif transdermique obliž uporaba površina: 15 cm2) vsebuje 8,25 mg fentanila (ustreza hitrosti sproščanja učinkovine 50 mikrogramov/h).
English: Drug dependence
Slovenian: Odvisnost od zdravila
English: Each patch of 7.5 cm2 contains 4.125 mg fentanyl.
Slovenian: Vsak transdermalni obliž z aktivno površino 7,5 cm2 vsebuje 4,125 mg fentanila (kar ustreza hitrosti sproščanja fentanila 25 mikrogramov/h).
English: HOW TO USE Fentanyl-ratiopharm
Slovenian: Kako uporabite obliž Fentanyl-ratiopharm
English: Fold used patches and discard or return to the pharmacy.
Slovenian: Uporabljene transdermalne obliže zvijte skupaj in jih zavrzite ali vrnite v lekarno.
English: [3 transdermal patches:] Date
Slovenian: [3 transdermalni obliži:] Datum ura
English: arrhythmia.
Slovenian: Dojenje
English: Do not use soap, oil, lotions, alcohol or other cleansers that may irritate the skin.
Slovenian: Če je potrebno, pred uporabo obliža kožo umijete s čisto vodo (brez katerih koli čistilnih sredstev kot so npr. mila, olja, losijoni, alkohol in podobno, ker tudi ta sredstva kožo razdražijo) in jo povsem posušite.
English: Corrective treatment may often be required (see section 4.8).
Slovenian: (glejte poglavje 4.8).
English: Ribofen 100 microgram/hr Transdermal patch (pending)
Slovenian: Ribofen 100 microgram/hr Transdermal patch (v obravnavi)
English: 4.9 Overdose
Slovenian: Zdravljenje ob prevelikem odmerku
English: At least 7 days should elapse before the same part is used again.
Slovenian: Obliž lahko namestite na isto mesto 7 dni po prejšnji namestitvi.
English: Transparent and colourless patch with blue imprint on the backing foil: “fentanyl 100 µg/h“.
Slovenian: Prozoren in brezbarven obliž z zaščitno oblogo z modrim napisom “fentanil 100 µg/h“.
English: Fentanyl-ratio 50 µg/h, dispositif transdermique The Netherlands Fentanyl ratiopharm 50, pleister voor transdermaal gebruik 50 µg/uur United Kingdom Ribofen 50 microgram/hr Transdermal patch
Slovenian: Fentanyl ratiopharm 50, pleister voor transdermaal gebruik 50 µg/uur Velika Britanija Ribofen 50 microgram/hr Transdermal patch
English: 100 µg/h transdermal patch transdermal use 16.5 mg/30 cm² which release 100 µg fentanyl per hour
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsak transdermalni obliž z aktivno površino 30 cm2 vsebuje 16,5 mg fentanila (kar ustreza hitrosti sproščanja fentanila 100 mikrogramov/h).
English: Transparent and colourless patch with blue imprint on the backing foil: “fentanyl 75 µg/h“.
Slovenian: Prozoren in brezbarven obliž z zaščitno oblogo z modrim napisom “fentanil 75 µg/h“.
English: fentanyl
Slovenian: GmbH
English: HOW TO STORE Fentanyl-ratiopharm
Slovenian: KAKO JEMATI ZDRAVILO FENTANYL-RATIOPHARM
English: Renal impairment
Slovenian: Bolezni ledvic
English: Each patch of 22.5 cm2 contains 12.375 mg fentanyl.
Slovenian: 1 obliž (aktivna površina: 22,5 cm2) vsebuje 12,375 mg fentanila (ustreza hitrosti sproščanja učinkovine 75
English: Dose titration and maintenance therapy
Slovenian: Membrana za sproščanje zdravila tetraftalatna folija
English: Transdermal patch
Slovenian: Merckle GmbH
English: Ribofen 25 microgram/hr Transdermal patch (pending)
Slovenian: Ribofen 25 microgram/hr Transdermal patch (v obravnavi)
English: How to apply Fentanyl-ratiopharm - Find a flat part of your upper body (trunk) or upper arm, where the skin is without hair, cuts, spots or other skin blemishes.
Slovenian: - Najdite ravno mesto na zgornjem delu telesa (trup) ali roki, kjer je koža neporaščena, ni poškodovana (porezana, popraskana) in brez drugih sprememb (materina znamenja, izrastki).
English: Ribofen 50 microgram/hr Transdermal patch (pending)
Slovenian: Ribofen 50 microgram/hr Transdermal patch (v obravnavi)
English: Ribofen 75 microgram/hr Transdermal patch (pending)
Slovenian: Ribofen 75 microgram/hr Transdermal patch (v obravnavi)
English: 75 µg/h transdermal patch transdermal use 12.375 mg/22.5 cm² which release 75 µg fentanyl per hour
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsak transdermalni obliž z aktivno površino 22,5 cm2 vsebuje 12,375 mg fentanila (kar ustreza hitrosti sproščanja fentanila 75 mikrogramov/h).
English: • the possible development of tolerance,
Slovenian: Zato bo potrebno prilagoditi odmerek (razvoj tolerance).
English: Skin and subcutaneous tissue disorders
Slovenian: Uporaba pri bolnikih z okvaro ledvic ali jeter
English: Fentanyl-ratiopharm is available in packs of 3, 5, 10 or 20 transdermal patches.
Slovenian: Škatle s 3, 5, 10, ali 20 transdermalnimi obliži.
English: Take special care with Fentanyl-ratiopharm
Slovenian: SHRANJEVANJE ZDRAVILA FENTANYL-RATIOPHARM
English: Transparent and colourless patch with blue imprint on the backing foil: “fentanyl 25 µg/h“.
Slovenian: Prozoren in brezbarven obliž z zaščitno oblogo z modrim napisom “fentanil 25 µg/h“.
English: Fentanyl is metabolised to inactive metabolites in the liver, so patients with hepatic disease might have a delayed elimination.
Slovenian: Pri bolnikih z okvarjenim delovanjem jeter je lahko izločanje fentanila počasnejše.
English: Occasionally, additional adhesion of the patch may be required.
Slovenian: Transdermalni obliž bo morda treba dodatno pritrditi.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF FENTANYLRATIOPHARM 25/50/75/100 µg/h TTS AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA FENTANYLRATIOPHARM IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each patch releases 25 micrograms fentanyl per hour.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsak transdermalni obliž z aktivno površino 15 cm2 vsebuje 8,25 mg fentanila (kar ustreza hitrosti sproščanja fentanila 50 mikrogramov/h).
English: Transparent and colourless patch with blue imprint on the backing foil: “fentanyl 50 µg/h“.
Slovenian: Prozoren in brezbarven obliž z zaščitno oblogo z modrim napisom “fentanil 50 µg/h“.
English: Fentanyl-ratiopharm 100 µg/h TTS and associated names (see Annex I)
Slovenian: Fentanyl-ratiopharm 100 µg/h TTS in povezana imena (glejte dodatek I) [Glejte dodatek I - Izpolni država članica]
English: Following intramuscular or subcutaneous administration the onset of action will be slower compared with intravenous administration.
Slovenian: Pri obeh načinih uporabe je delovanje zdravila le nekoliko počasnejše kot pri intravenski uporabi.
English: Uncommon: diarrhoea.
Slovenian: Žilne bolezni Občasni:
English: The Netherlands ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, Germany
Slovenian: Nizozemska ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Nemčija
English: Patients with hepatic impairment should be observed carefully and the dose reduced if necessary.
Slovenian: Zato je treba te bolnike skrbno opazovati in po potrebi uporabiti manjše odmerke zdravila.
English: NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 100 µg/h TTS and associated names (see Annex I) [See Annex I - To be completed nationally] fentanyl
Slovenian: NAVODILO ZA UPORABO Fentanyl-ratiopharm 100 µg/h TTS in povezana imena (glejte dodatek I) [Glejte Dodatek I - Izpolni država članica] fentanil
English: Ketobemidone 10
Slovenian: kserostomija, dispepsija
English: France ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, Germany
Slovenian: Francija ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Nemčija
English: Germany ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, Germany
Slovenian: Nemčija ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Nemčija
English: Tolerance, physical or psychological dependence may develop if you use Fentanyl-ratiopharm for a longer period.
Slovenian: Pri dolgotrajni uporabi obližev Fentanyl-ratiopharm se lahko pojavi psihična ali telesna odvisnost.
English: NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 25 µg/h TTS and associated names (see Annex I) [See Annex I - To be completed nationally]
Slovenian: Fentanyl-ratiopharm 25 µg/h TTS in povezana imena (glejte dodatek I) [Glejte dodatek I - Izpolni država članica]
English: Withdrawal symptoms may be nausea, vomiting, diarrhoea, anxiety and shivering.
Slovenian: Odtegnitveni simptomi so slabost, bruhanje, driska, tesnoba in trzanje mišic.
English: NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 75 µg/h TTS and associated names (see Annex I) [See Annex I - To be completed nationally]
Slovenian: Fentanyl-ratiopharm 75 µg/h TTS in povezana imena (glejte dodatek I) [Glejte dodatek I - Izpolni država članica]
English: NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 75 µg/h TTS and associated names (see Annex I) [See Annex I - To be completed nationally] fentanyl
Slovenian: NAVODILO ZA UPORABO Fentanyl-ratiopharm 75 µg/h TTS in povezana imena (glejte dodatek I) [Glejte Dodatek I - Izpolni država članica] fentanil
English: NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 50 µg/h TTS and associated names (see Annex I) [See Annex I - To be completed nationally]
Slovenian: Fentanyl-ratiopharm 50 µg/h TTS in povezana imena (glejte dodatek I) [Glejte dodatek I - Izpolni država članica]
English: 25 µg/h transdermal patch transdermal use 4.125 mg/7.5 cm² which release 25 µg fentanyl per hour
Slovenian: 1 obliž (aktivna površina: 7,5 cm2) vsebuje 4,125 mg fentanila (ustreza hitrosti sproščanja učinkovine 25 mikrogramov/h)
English: NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 50 µg/h TTS and associated names (see Annex I) [See Annex I - To be completed nationally] fentanyl
Slovenian: NAVODILO ZA UPORABO Fentanyl-ratiopharm 50 µg/h TTS in povezana imena (glejte dodatek I) [Glejte Dodatek I - Izpolni država članica] fentanil
English: NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 25 µg/h TTS and associated names (see Annex I) [See Annex I - To be completed nationally] fentanyl
Slovenian: Fentanyl-ratiopharm 25 µg/h TTS in povezana imena (glejte dodatek I) [Glejte Dodatek I - Izpolni država članica] fentanil
English: This may increase or prolong both the therapeutic effects and the adverse reactions, which may cause severe respiratory depression.
Slovenian: Interakcija med transdermalno uporabljenim fentanilom in močnimi zaviralci encima CYP3A4 lahko podaljša tako terapevtski učinek in povzroči neželene učinke, vključno z močno respiratorno depresijo.
English: Do not under any circumstances use a double dose.
Slovenian: Če ste pozabili uporabiti obliž Fentanyl-ratiopharm Pod nobenimi pogoji ne vzemite dvojnega odmerka.
English: United Kingdom ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm, Germany
Slovenian: Velika Britanija ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Nemčija
English: Bear in mind that the design of this medicinal product could be tempting to a child. Fentanyl-ratiopharm can have life-threatening side-effects in persons that are not using prescribed opioid medicines on a regular basis.
Slovenian: Za osebe, ki se ne zdravijo redno s predpisanimi opioidi, so neželeni učinki obližev Fentanylratiopharm lahko življensko nevarni.