natgillin/translations-raw huggingface dataset:
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.
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.
Prior to application, the skin should be carefully washed with clean water (no cleaning agents) and thoroughly dried.
Pred uporabo obliža morate kožo umiti le s čisto vodo (brez katerih koli čistilnih sredstev) in jo osušiti.
Reversing the narcotic effect can give rise to acute pain and release of catecholamines.
Ob koncu narkotičnega učinka se lahko pojavita akutna bolečina in sproščanje kateholaminov.
There is also no clinical data available which demonstrates withdrawal symptoms in patients treated with transdermal fentanyl after injection of buprenorphine.
Ravno tako ni na voljo kliničnih podatkov, ki bi dokazovali odtegnitvene simptome pri bolnikih, zdravljenih s transdermalnim fentanilom, po injiciranju buprenorfina.
[See Annex I - To be completed nationally]
[Glejte dodatek I - Izpolni država članica]
However, from the clinical point of view, this aspect represents only a minor risk for patients receiving transdermal fentanyl pain therapy in average doses.
Vendar pa predstavlja ta vidik s kliničnega stališča le manjše tveganje za bolnike, ki prejemajo protibolečinsko zdravljenje na osnovi transdermalnega fentanila v povprečnih odmerkih.
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
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
In case of withdrawal symptoms it is recommended to treat those with short-acting morphine in low doses.
V primeru pojava simptomov odtegnitve je priporočljivo le te zdraviti s kratkotrajno delujočim morfinom v nizkih odmerkih.
When treatment with Fentanyl-ratiopharm is withdrawn, serum fentanyl concentrations decline gradually, falling approximately 50 % in 13-22 hours in adults or 22-25 hours in children, respectively.
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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte s svojim zdravnikom ali farmacevtom.
The concomitant use of barbituric acid derivatives should be avoided, since the respiratory depressing effect of fentanyl may be increased.
Sočasni uporabi derivatov barbituratne kisline se moramo izogibati, ker lahko poveča učinek respiratorne depresije fentanila.
Any breast milk produced during treatment or within 72 hours after the removal of the last patch should be discarded.
Materino mleko med zdravljenjem ali pridobljeno prej kot 72 ur po zadnji odstranitvi transdermalnih obližev je potrebno zavreči.
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.
Če ste starejši bolnik ali ste v slabi telesni kondiciji (slaboten) vas mora vaš zdravnik skrbno nadzorovati.
Pharmacokinetics in special groups
Farmakokinetika pri posebnih skupinah bolnikov
Patches with a release rate of 12.5 micrograms/hour are available and are appropriate for dose titration in the lower dosage area.
Obliži s hitrostjo sproščanja 12,5 mikrogramov/h, ki so na voljo, so primerni za prilagajanje odmerka v območju nizkih odmerkov.
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.
V teh primerih je zdravljenje bolje začeti z nizkimi odmerki morfina s takojšnjim sproščanjem in predpisati zdravljenje z obliži Fentanylratiopharm po določitvi optimalnega odmerka.
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.
Pri bolnikih z boleznijo ledvic ali jeter je lahko očistek fentanila spremenjen zaradi sprememb plazemskih proteinov in izločanja, kar povzroči povečano koncentracijo v serumu.
Other undesirable effects
Drugi neželeni učinki
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
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.
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.
Odmerek se običajno povečuje v presledkih po 25 mikrogramov/uro, vendar morate pri tem upoštevati bolnikove potrebe po dodatnih zdravilih in stopnjo bolečine.
If you are very late changing your patch then you should contact your doctor because you might need some extra painkillers.
Če ste se spomnili in zamenjali obliž zelo prepozno, se posvetujte s svojim zdravnikom, ker bodo morda potrebna dodatna zdravila proti bolečinam.
The CHMP recommended also adding the following statement in section 4.4 of the SPC: “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.”
CHMP je priporočil tudi vključitev naslednje navedbe v poglavje 4.4 povzetka glavnih značilnosti zdravila: „Pri kronični nerakavi bolečini utegne biti priporočljivo začeti zdravljenje z močnimi opioidi s takojšnjim sproščanjem (npr. morfinom) in predpisati fentanil v transdermalnem obližu po določitvi učinkovitosti in optimalnega odmerjanja močnih opioidov.“
These medicines may increase the effects and side effects of Fentanyl-ratiopharm.
Ta zdravila lahko zvišajo učinkovitost in neželene učinke obližev Fentanyl-ratiopharm.
If needed, a similar dose can be given every 2 or 3 minutes, or be administered as continued infusion as 2 mg in 500 ml sodium chloride 9 mg/ml (0.9 %) solution for injection or glucose 50 mg/ml (5 %) solution.
Začetni odmerek po potrebi ponavljajte na 2 do 3 minute ali ga dajte kot neprekinjeno infuzijo 2miligramskega odmerka v 500 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje ali ratopine glukoze 50 mg/ml (5 %).
Treatment with Fentanyl-ratiopharm should only be initiated by an experienced physician familiar with the pharmacokinetics of fentanyl transdermal patches and the risk for severe hypoventilation.
Zdravljenje z obliži Fentanyl-ratiopharm lahko začne le izkušen zdravnik, ki je seznanjen s farmakokinetiko transdermalnih obližev fentanila in s tveganjem hude hipoventalacije.
This applies, for example, to: - ritonavir (used to treat AIDS) - ketoconazole, itraconazole (used to treat fungal diseases) - diltiazem (used to treat heart disease) - cimetidine (used to treat gastrointestinal diseases) - macrolide antibiotics (used to treat infections)
To velja za: - ritonavir (zdravilo za zdravljenje AIDS-a) - ketokonazol, itrakonazol (zdravila za zdravljenje glivičnih okužb) - diltiazem (zdravila za zdravljenje bolezni srca) - cimetidin (zdravila za zdravljenje bolezni prebavil) - makrolidni antibiotiki (zdravila za zdravljenje okužb)
The peak-to-trough fluctuations of plasma concentrations are higher with the reference product and are not of a high magnitude.
Nihanja v razmerju med najvišjo in najnižjo plazemsko koncentracijo so pri referenčnem izdelku večja in niso velikega obsega.
These actions can be followed by administration of a specific opioid antagonist such as naloxone.
Tem ukrepom lahko sledi uporaba opioidnega antagonista, kot je nalokson.
Please tell your doctor if you are taking MAO inhibitors (e.g. moclobemide against depression or selegiline against Parkinson's disease) or have taken them within the last 14 days.
Prosimo obvestite svojega zdravnika, če jemljete ali ste v zadnjih 14 dneh jemali zaviralce monoaminooksidaze (npr. moklobemid proti depresiji ali selegilin proti Parkinsonovi bolezni).
In patients with existing respiratory depression, fentanyl should only be used with caution and at a lower dose.
Pri bolnikih z obstoječo respiratorno depresijo je treba fentanil uporabljati previdno in v manjših odmerkih.
Fentanyl-ratiopharm should not be administered to children under 12 years of age because there is limited experience of use in children.
Obližev Fentanyl-ratiopharm na splošno pri otrocih mlajših od 12 let ne uporabljajte, ker so izkušnje z uporabo omejene.
sedation, nervousness, loss of appetite.
sedacija, živčnost, zmanjšan apetit
PHARMACEUTICAL FORM AND CONTENTS 1 transdermal patch
FARMACEVTSKA OBLIKA IN VSEBINA 1 transdermalni obliž
Lactation should therefore be discontinued for at least 72 hours after the removal of fentanyl transdermal patch”
Posledično je treba dojenje prekiniti za najmanj 72 ur po odstranitvi transdermalnega obliža s fentanilom“.
Do not use Fentanyl-ratiopharm - if you are hypersensitive (allergic) to fentanyl or any of the other ingredients of the product.
Ne uporabljajte obližev Fentanyl-ratiopharm: - če ste alergični na (preobčutljivi na) fentanil ali katero koli sestavino zdravila.
For management of respiratory depression immediate countermeasures should be started, including removing the patch and physically or verbally stimulating the patient.
Takojšnja ukrepa pri respiratorni depresiji sta odstranitev transdermalnega obliža ter fizična in verbalna stimulacija bolnika.
Around 75 % of fentanyl is excreted into the urine, mostly as metabolites, with less than 10 % as unchanged active substance.
Okoli 75 % fentanila se izloča z urinom, večinoma v obliki presnovkov (nespremenjenega zdravila je manj kot 10 %).
In patients who experience a marked decrease in the period 48-72 hours after application, replacement of fentanyl after 48 hours may be necessary.
Pri bolnikih, pri katerih pride do znatnega zmanjšanja analgetičnega učinka v 48 do 72 urah po namestitvi obliža, je treba transdermalni obliž fentanila po 48 urah zamenjati.
Increased plasma concentrations were, however, observed in individual subjects.
Pri posameznikih so opazili zvišane koncentracije zdravila v plazmi.
On the outer package you can write the date and time you applied the patch.
Na zunanjo ovojnino lahko zapišete datum in uro namestitve.
While waiting for the doctor, keep the person awake by talking to or shaking her/him now and then.
Medtem ko čakate na zdravnika poizkusite obdržati bolnika v budnem stanju tako, da se z njim pogovarjate, ga občasno stresite.
They have high affinity to opioid receptors with relatively low intrinsic activity and therefore partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependant patients (see also section 4.4).
Ker imajo visoko afiniteto za opioidne receptorje z zelo nizko intrinzično aktivnostjo tako delno nasprotujejo analgetičnemu učinku fentanila in lahko povzročijo pojav odtegnitvenih simptomov (glejte poglavje 4.4).
The painkiller, fentanyl, slowly passes from the patch, through the skin and into the body.
Analgetik fentanil počasi prehaja iz obliža skozi kožo v telo.
Patients with myasthenia gravis
Bolniki z miastenijo gravis
respiratory depression, apnoea.
respiratorna depresija, apneja
Regarding breast-feeding, section 4.6 of the proposed SPC reads: “Fentanyl is excreted into breast milk and may cause sedation and respiratory depression in the breastfed infant.
V zvezi z dojenjem se poglavje 4.6 predlaganega povzetka glavnih značilnosti zdravila glasi: „Fentanil se izloča v materino mleko in utegne povzročati sedacijo in respiratorno depresijo pri dojenih dojenčkih.
General disorders and administration site conditions Rare:
Splošne motnje in težave na mestu aplikacije Redki:
The need to perform a bioequivalence study with the highest strength and a valid study with replicate design was discussed.
Obravnavana je bila potreba po izvedbi bioekvivalenčne študije z največjo jakostjo in veljavne študije na podlagi ponovitvenega načrta.
Both the lowest effective fentanyl concentration and the concentration causing adverse reactions will increase with the development of increasing tolerance.
Najnižja učinkovita koncentracija fentanila in koncentracija pri kateri nastopijo možni neželeni učinki se lahko pri razvoju tolerance zvišata.
When changing over from oral or parenteral opioids to fentanyl treatment, the initial dosage should be calculated as follows:
Ob prehodu s peroralnih ali parenteralnih opioidov na zdravljenje s fentanilom izračunajte začetni odmerek, kot je opisano v nadaljevanju:
Patients with fever/external heat
Zvišana telesna temperatura/zunanji viri toplote
Switching from other opioids
Prehod iz drugega zdravljenja z opioidi
Finally, regarding the demonstration of bioequivalence, the discussions pertained to the deviations to the guideline “Note for guidance on modified release oral and trans-dermal dosage forms: section II: pharmacokinetic and clinical evaluation- (CPMP/EWP/280/96)”.
Razprava v zvezi z dokazovanjem bioekvivalence se je nanašala na odstopanje od smernice „Navodila za peroralne in transdermalne farmacevtske oblike s prirejenim sproščanjem: poglavje II: farmakokinetično in klinično vrednotenje (CPMP/EWP/280/96)“.
However, studies of fentanyl transdermal patch in elderly patients demonstrated fentanyl pharmacokinetics which did not differ significantly from young patients although serum concentrations tended to be higher.
Študije transdermalnih obližev fentanila pri starejših bolnikih so pokazale, da farmakokinetika fentanila ni bila bistveno drugačna kot pri mlajših bolnikih, čeprav so koncentracije v serumu bile višje.
Psychiatric disorders Very common: somnolence.
Psihiatrične motnje Zelo pogosti: zaspanost Pogosti:
About 9 % of the dose is recovered in the faeces, primarily as metabolites.
V blatu se izloči približno 9 % odmerka, zlasti v obliki presnovkov.
Fentanyl-ratiopharm should be used with caution in patients who may be particularly susceptible to the intracranial effects of CO2 retention such as those with evidence of increased intracranial pressure, impaired consciousness or coma.
Fentanyl-ratiopharm uporabljajte še posebej previdno pri bolnikih, občutljivih na učinke intrakranialnega zadrževanja ogljikovega dioksida, na primer pri tistih, pri katerih so se v preteklosti že pojavili povišan intrakranialni pritisk, stanje zmanjšane zavesti ali koma.
Oral administration of ritonavir (one of the most potent CYP3A4 inhibitors) reduced the clearance of intravenous fentanyl by two thirds and doubled the halflife.
Peroralna aplikacija ritonavira (eden najmočnejših zaviralcev encima CYP3A4) je zmanjšala očistek intravensko danega fentanila za dve tretjini in podvojila razpolovni čas.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Ime in naslov imetnika dovoljenja za promet:
Uncommon: tremor, paraesthesia, speech disorder.
tremor, paraestezija, motnje govora
What Fentanyl-ratiopharm is and what it is used for Before you use Fentanyl-ratiopharm How to use Fentanyl-ratiopharm Possible side effects
Kaj je zdravilo Fentanyl-ratiopharm in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Fentanyl-ratiopharm Kako jemati zdravilo Fentanyl-ratiopharm Možni neželeni učinki
The Composite foil containing the following layers from outside to inside: coated Kraft paper, low density polyethylene foil, aluminium foil, Surlyn (thermoplastic ethylene-methacrylic acid copolymer).
Sestava plasti od zunaj na vznoter: kraft papir, polietilenska folija nizke gostote, folija iz aluminija, Surlyn (termoplastični kisli etilenmetakrilni kopolimer).
The patches should not be cut into smaller parts, because the quality, efficacy and safety of such divided patches have not been demonstrated.
Transdermalnih obližev ne smete razrezati na manjše kose, ker podatkov o kvaliteti, učinkovitosti in varnosti tako deljenih obližev ni.
If these medicines are taken together this may enhance their toxicity.
Ta zdravila lahko povečajo toksičnost zdravljenja.
Chronic pulmonary disease
Kronična pljučna bolezen
Biotransformation
Biološka transformacija:
The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended.
Ne priporočamo sočasne uporabe buprenorfina, nalbufina ali pentazocina.
Itraconazole (a potent CYP3A4 inhibitor) at 200 mg/day given orally for four days had no significant effect on the pharmacokinetics of intravenous fentanyl.
Peroralna uporaba itrakonazola (močnega zaviralca encima CYP3A4) v dnevnih odmerkih 200 mg in v trajanju 4 dni ni znatno vplivala na farmakokinetiko intravensko uporabljenega fentanila.
Other signs and symptoms of overdose are drowsiness, low body temperature, slow heart rate, decreased muscle tone, deep sedation, loss of muscle co-ordination, constriction of the pupils and convulsions.
Drugi znaki in simptomi prevelikega odmerjanja so zaspanost, nizka telesna temperature, počasen utrip srca, zmanjšan tonus mišic, globoka sedacija, izguba koordinacije delovanja mišic, zoženje zenic in krči.
Uncommon: tachycardia, bradycardia.
tahikardija, bradikardija
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
- Če katerikoli neželeni učinek postane resen ali, če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
After the first application of Fentanyl-ratiopharm, serum fentanyl concentrations increase gradually, generally levelling off between 12 and 24 hours, and remaining relatively constant for the remainder of the 72-hour application period.
Po prvi uporabi obližev Fentanyl-ratiopharm koncentracija zdravila v serumu počasi narašča, po 12 do 24 urah se stabilizira in ostane razmeroma stabilna še ves preostali čas 72-urnega obdobja uporabe.
If you wish to interrupt or stop the treatment, you should always talk to your doctor about the reasons for discontinuation and your continued treatment.
Če želite zdravljenje prekiniti ali ustaviti, se o razlogih za to vedno predhodno posvetujte s svojim zdravnikom.
Simultaneous use of Fentanyl-ratiopharm and alcoholic beverages increases the risk of severe adverse reactions, and may cause breathing difficulties, a fall of blood pressure, profound sedation and coma.
Sočasno uživanje alkohola in uporaba obližev Fentanyl-ratiopharm poveča tveganje za hude neželene učinke, ki lahko povzročijo težave s dihanjem, padec krvnega tlaka, globoko sedacijo in komo.
Fentanyl-ratiopharm should not be used during pregnancy and breast-feeding unless clearly necessary.
Obliži Fentanylratiopharm se med nosečnostjo in dojenjem ne uporabljajo razen, če je to nujno potrebno.
Studies have shown that almost all patients, despite treatment with a fentanyl patch, require supplemental treatment with potent rapid-release medicinal products to arrest breakthrough pain.
Študije so pokazale, da je skoraj pri vseh bolnikih, kljub zdravljenju z obliži fentanila, v primeru t. i. "preboja bolečine", potrebno dodatno zdravljenje z močnimi, hitro delujočimi zdravili proti bolečinam.
MAO-inhibitors have been reported to increase the effect of narcotic analgesics, especially in patients with cardiac failure.
Zaviralci monoaminooksidaze (MAO-inhibitorji) povečajo učinek narkotičnih analgetikov, še posebej pri bolnikih z boleznimi srca.
In very elderly or weak patients, it is not recommended to initiate an opioid treatment with Fentanylratiopharm, due to their known susceptibility to opioid treatments.
Pri zelo starih ali šibkih bolnikih zdravljenje z obliži Fentanyl-ratiopharm ni priporočljivo zaradi njihove občutljivosti na zdravljenje z opioidnimi analgetiki.
Each transdermal patch is packed in a separate sachet.
Transdermalni obliži so pakirani posamezno v zaščitne blazinice.
Skin rash and skin reddening will usually disappear within one day after the patch has been removed.
Kožni izpuščaj in rdečica kože ponavadi izgineta dan po odstranitvi obliža.
The CNS depressants mentioned above include: - opioids - anxiolytics and tranquilizers - hypnotics - general anaesthetics - phenothiazines - skeletal muscle relaxants - sedating antihistamines - alcoholic beverages
Zaviralci osrednjega živčnega sistema omenjeni zgoraj vključujejo: - opioide - anksiolitike - hipnotike - splošne anestetike - fenotiazine - mišične relaksante - sedativne antihistaminike - in alkoholne pijače
The symptoms of fentanyl overdose are an extension of its pharmacological actions, e.g. lethargy, coma, respiratory depression with Cheyne-Stokes respiration and/or cyanosis.
Znaki prevelikega odmerjanja so povečani farmakološki učinki fentanila, kot so stupor, koma, respiratorna depresija s Cheyne-Stokesovim dihanjem in/ali cianoza.
For all practical purposes by the second 72-hour application, a steady state serum concentration is reached and is maintained during subsequent applications of a patch of the same size.
Po 72urni uporabi je v serumu doseženo stanje dinamičnega ravnovesja, ki se vzdržuje z nadaljno uporabo obližev enake velikosti.
In addition, the CHMP recommends including the following information in section 4.4 of the SPC:
Nadalje CHMP predlaga, da se v poglavje 4.4 povzetka glavnih značilnosti zdravila vključi naslednja informacija:
If any of the following serious, very rare side effects occur your should discontinue treatment and immediately contact your doctor or visit a hospital: severe respiratory depression (severe breathlessness, rattling breath) or complete block of the digestion channel (convulsive pain, vomiting, flatulence).
Če opazite katere koli od naštetih resnih, zelo redkih neželenih učinkov, takoj prenehajte z zdravljenjem in o tem nemudoma obvestite svojega zdravnika ali nemudoma obiščite najbližjo bolnišnico: omejeno sposobnost dihanja (huda depresija dihanja) ali zaporo prebavnega trakta (krče z bolečinami, bruhanje, napenjanje in plini).
Transdermal fentanyl release (micrograms/h)
Transdermalno sproščanje fentanila (mikrogrami/h)
Signs of toxicity are deep sedation, ataxia, miosis, convulsions and respiratory depression, which is the main symptom.
Znaki zastrupitve so globoka sedacija, ataksija, mioza, epileptični napadi in respiratorna depresija, ki je najpomembnejši simptom.
Directly after removal from the pack and the release liner, the patch is applied to a non-hairy area of skin on the upper body (chest, back, upper arm).
Takoj potem, ko odstranite ovojnino, morate transdermalni obliž namestiti na neporaščeno kožo na zgornjem delu telesa (prsni koš, hrbet, nadlahet).
By combining several transdermal patches, a fentanyl release rate of over 100 micrograms/h can be achieved.
S kombinacijo večih transdermalnih obližev lahko dosežemo hitrost sproščanja fentanila prek 100 mikrogramov/h.