natgillin/translations-raw huggingface dataset:
less than 1 in 10, but more than 1 in 100 patients less than 1 in 100, but more than 1 in 1000 patients less than 1 in 1000, but more than 1 in 10,000 patients less than 1 in 10,000 patients, including isolated reports
več kot 1 od 10 bolnikov zelo pogosti manj kot 1 od 10, vendar več kot 1 od 100 bolnikov pogosti manj kot 1 od 100, vendar več kot 1 od 1. 000 bolnikov občasni manj kot 1 od 1. 000, vendar več kot 1 od 10. 000 bolnikov redki manj kot 1 od 10. 000 bolnikov, vključno s posameznimi primeri zelo redki
Other side effects Very common:
Drugi neželeni učinki:
Somnolence, headache, dizziness, nausea, vomiting, constipation, sweating, itching.
Zelo pogosti: zaspanost, glavobol, omotica, slabost, bruhanje, zaprtost, potenje, srbenje.
Unnatural feeling of happiness, memory loss, difficulties in sleeping, hallucinations, agitation, tremor, sensitivity disturbances, speech disorders, fall or rise in the blood pressure and heart rate, difficulties in breathing, diarrhoea, difficulty in passing urine, skin rash, skin reddening (erythema).
nenavadno občutje sreče, izguba spomina, težave s spanjem, prividi, razdraženost, tresenje, motnje zaznavanja, motnje govora, padec ali dvig krvnega tlaka in utripa srca, težave z dihanjem, driska, težave pri odvajanju vode, kožni izpuščaj, rdečica kože (eritem).
Generalised acute allergic reactions with a fall in the blood pressure and/ or difficulty in breathing (anaphylactic reactions), delusional ideas, states of excitement, loss of physical strength, depression, anxiety, confusion, sexual dysfunction, withdrawal symptoms, coordination disturbances, seizures (including clonic and grand mal seizures), diminished visual acuity, impaired respiration (respiratory depression), respiratory arrest (apnoea), painful bloating, block of the digestion channel, urinary bladder pain, passing water less than normal (reduced urine excretion).
generalizirane alergične reakcije s padcem krvnega tlaka in/ ali težko dihanje (anafilaktične reakcije), privide, stanje vzdraženosti, izguba fizične moči, depresija, tesnoba, zmedenost, motnje spolnih funkcij, odtegnitveni znaki, motnje koordinacije, epileptični napadi (klonični in grand mal napadi), zmanjšana ostrina vida, motnje dihanja (depresija dihanja), zastoj dihanja (apnena), boleče napenjanje, zapora prebavnega trakta, bolečine v mehurju, zmanjšano izločanje urina.
If you have been will become less develop).
13 Pri dolgotrajni uporabi obližev Fentanyl- ratiopharm se lahko zgodi, da bodo obliži Fentanyl - ratiopharm postali manj učinkoviti.
using Fentanyl-ratiopharm for some time, it might happen that Fentanyl-ratiopharm effective for you so that a dose adjustment will be necessary (tolerance may
Zato bo potrebno prilagoditi odmerek (razvoj tolerance).
HOW TO STORE Fentanyl-ratiopharm
SHRANJEVANJE ZDRAVILA FENTANYL- RATIOPHARM
Keep out of the reach and sight of children, even after use.
Tudi po uporabi.
High quantities of the active substance remain in the transdermal patches even after use.
Visoke količine fentanila ostajajo v transdermalnih obližih tudi po uporabi.
Do not store above 25 °C.
Shranjujte pri temperaturi do 250 C.
For environmental and safety reasons, used as well as unused and out of date patches must be discarded or returned to the pharmacy for disposal.
Shranjujte v originalni ovojnini.
Used patches should be folded in half with the sticky sides together.
Uporabljene transdermalne obliže zvijte skupaj tako, da se lepljive površine dotikajo, shranite v zunanjo ovojnino in jih odstranite na ustrezen način.
Put back used patches in the outer package and discard or whenever possible hand in to your pharmacist.
Kadar je le možno, jih vrnite svojemu farmacevtu.
What Fentanyl-ratiopharm contains
Kaj vsebujejo obliži Fentanyl- ratiopharm
- The active substance is fentanyl.
- Zdravilna učinkovina je: fentanil
Polyacrylate adhesive layer Backing film:
Lepljiva površina: poliakrilatni adheziv Zaščitna obloga: polipropilenska folija, modro črnilo za tisk Membrana za sproščanje zdravila: tetraftalatna folija
Polyethylene terephthalate foil (siliconised)
Farmacevtska oblika s sestavo pakiranja
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.
Obliži Fentanyl- ratiopharm so prozorni transdermalni obliži z lepljivim hrbtiščem, ki ga lahko prilepimo na kožo.
Marketing Authorisation Holder
Ime in naslov imetnika dovoljenja za promet:
Manufacturer Merckle GmbH Ludwig-Merckle-Str.
Merckle GmbH
Austria Germany
3 89143 Blaubeuren Nemčija
Fentanyl-ratiopharm 25 µg/ h transdermales Matrixpflaster Fentanyl-ratiopharm 25 µg/ h Matrixpflaster
Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni:
Spain France The Netherlands United Kingdom
< DE/ H/ 0739/ 01/ MR > Avstrija Nemčija Španija Francija Nizozemska Velika Britanija
This leaflet was last approved in {MM/ YYYY}.
Navodilo je bilo
INFORMATION FOR THE USER
15 NAVODILO ZA UPORABO
86 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.
4 Prosimo obvestite svojega zdravnika, če jemljete ali ste v zadnjih 14 dneh jemali zaviralce monoaminooksidaze (npr. moklobemid proti depresiji ali selegilin proti Parkinsonovi bolezni).
How to apply Fentanyl-ratiopharm
5 Kako uporabite obliž Fentanyl- ratiopharm
If you have been will become less develop).
7 Pri dolgotrajni uporabi obližev Fentanyl- ratiopharm se lahko zgodi, da bodo obliži Fentanyl - ratiopharm postali manj učinkoviti.
Fentanyl-ratiopharm 50 µg/ h transdermales Matrixpflaster Fentanyl-ratiopharm 50 µg/ h Matrixpflaster
Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni:
Spain France The Netherlands United Kingdom
< DE/ H/ 0739/ 02/ MR > Avstrija Nemčija Španija Francija Nizozemska Velika Britanija
91 PACKAGE LEAFLET:
9 NAVODILO ZA UPORABO
93 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.
4 Prosimo obvestite svojega zdravnika, če jemljete ali ste v zadnjih 14 dneh jemali zaviralce monoaminooksidaze (npr. moklobemid proti depresiji ali selegilin proti Parkinsonovi bolezni).
Fentanyl-ratiopharm 75 µg/ h transdermales Matrixpflaster Fentanyl-ratiopharm 75 µg/ h Matrixpflaster
Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni:
Spain France The Netherlands United Kingdom
< DE/ H/ 0739/ 03/ MR > Avstrija Nemčija Španija Francija Nizozemska Velika Britanija
98 PACKAGE LEAFLET:
9 NAVODILO ZA UPORABO
100 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.
4 Prosimo obvestite svojega zdravnika, če jemljete ali ste v zadnjih 14 dneh jemali zaviralce monoaminooksidaze (npr. moklobemid proti depresiji ali selegilin proti Parkinsonovi bolezni).
Fentanyl-ratiopharm 100 µg/ h transdermales Matrixpflaster Fentanyl-ratiopharm 100 µg/ h Matrixpflaster
Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni:
Spain France The Netherlands United Kingdom
< DE/ H/ 0739/ 04/ MR > Avstrija Nemčija Španija Francija Nizozemska Velika Britanija
105
9
London, 23 October 2007 EMEA/ 338591/ 2007
London, 23. oktober 2007 EMEA/ 331678/ 2007
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Fentanyl-ratiopharm 25/ 50/ 75/ 100 µg/ h Matrixpflaster and associated names
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 29( 4) 1 ZA Fentanyl- ratiopharm 25/ 50/ 75/ 100 µg/ h Matrixpflaster in z njim povezana imena
Fentanyl-ratiopharm 25/ 50/ 75/ 100 µg/ h Matrixpflaster and associated names, is an opioid analgesic which is indicated in severe chronic pain which can be adequately managed only with opioid analgesics.
Fentanyl- ratiopharm 25/ 50/ 75/ 100 µg/ h Matrixpflaster in z njim povezana imena so opioidni analgetiki, indicirani za hude kronične bolečine, ki jih je mogoče primerno blažiti le z opioidnimi analgetiki.
Ratiopharm GmbH submitted applications for mutual recognition of Fentanyl-ratiopharm 25/ 50/ 75/ 100 µg/ h Matrixpflaster and associated names, transdermal patch on the basis of the marketing authorisation granted by Germany 04 April 2006.
Družba Ratiopharm GmbH je predložila vlogo za postopek medsebojnega priznavanja zdravila Fentanyl - ratiopharm 25/ 50/ 75/ 100 µg/ h Matrixpflaster in z njim povezanih imen v obliki transdermalnega obliža na osnovi dovoljenja za promet z zdravilom, ki ga je Nemčija odobrila dne 4. aprila 2006.
During their July 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Fentanyl- ratiopharm 25/ 50/ 75/ 100 µg/ h Matrixpflaster and associated names, that the objections raised by France should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Med svojim zasedanjem julija 2007 je bil CHMP na podlagi vseh predloženih podatkov in znanstvene razprave v okviru Odbora mnenja, da je razmerje med koristmi in tveganji za zdravilo Fentanyl- ratiopharm 25/ 50/ 75/ 100 µg/ h Matrixpflaster in z njim povezana imena ugodno, da ugovori, ki jih je imela Francija, ne bi smeli preprečiti izdaje dovoljenja za promet z zdravilom in da je treba Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo dopolniti.
The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Znanstveni zaključki so na voljo v Dodatku II, skupaj s Povzetkom glavnih značilnosti zdravila v Dodatku III.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 13 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Evropska komisija je končno mnenje spremenila v odločbo dne 23. oktobra 2007.
ratiopharm Arzneimittel Vertriebs- GmbH Albert-Schweitzer- Gasse 3, 1140 WIEN, Austria
ratiopharm
Fenturogenox 25 µg/ h - transdermales Matrixpflaster
Fenturogenox
transdermal patch
transdermalna
transdermal use
1 obliž (aktivna
4.125 mg/ 7.5 cm² which release 25 µg fentanyl per hour
vsebuje 4, 125 mg fentanila (ustreza hitrosti sproščanja učinkovine 25 mikrogramov/ h)
Fenturogenox 50 µg/ h - transdermales Matrixpflaster
50 µg/ h
50 µg/ h
50 µg/ h - transdermales Matrixpflaster
ratiopharm GmbH Graf-Arco-Str.
ratiopharm GmbH
3, 89079 Ulm, Germany
Fentanyl- ratio
Fentanyl-ratio 50 µg/ h, dispositif transdermique
50 µg/ h
50 µg/ h
50 µg/ h, dispositif transdermique
3 The Netherlands
4 Nizozemska
Fentanilo Matrix ratiomed 25 microgramos/ h parches transdérmicos EFG
Fentanilo Matrix 25 µg/ h ratiomed 25 microgramos/ h parches transdérmicos EFG
Fentanilo Matrix ratiomed 50 microgramos/ h parches transdérmicos EFG
Fentanilo Matrix 50 µg/ h ratiomed 50 microgramos/ h parches transdérmicos EFG
Fentanilo Matrix ratiomed 75 microgramos/ h parches transdérmicos EFG
Fentanilo Matrix 75 µg/ h ratiomed 75 microgramos/ h parches transdérmicos EFG
Avenida de Burgos 16D, 5º Planta, 28036
Avenida de Burgos 16D, 5º Planta, 28036 Madrid, Spanija
Fentanilo Matrix ratiomed 100 microgramos/ h parches
Fentanilo Matrix 100 µg/ h ratiomed 100 microgramos/ h parches transdérmicos EFG
transdérmicos EFG
Velika Britanija
Ribofen 25 microgram/ hr Transdermal patch (pending)
Ribofen 25 25 µg/ h microgram/ hr Transdermal patch (v obravnavi)
Ribofen 50 microgram/ hr Transdermal patch (pending)
Ribofen 50 50 µg/ h microgram/ hr Transdermal patch (v obravnavi)
Ribofen 75 microgram/ hr Transdermal patch (pending)
Ribofen 75 75 µg/ h microgram/ hr Transdermal patch (v obravnavi)
Ribofen 100 microgram/ hr Transdermal patch (pending)
Ribofen 100 100 µg/ h microgram/ hr Transdermal patch (v obravnavi)
16.5 mg/ 30 cm² which release 100 µg fentanyl per hour
6 učinkovine 100 mikrogramov/ h).
5 ANNEX II
7 DODATEK II
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA( OV) GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
6 SCIENTIFIC CONCLUSIONS
8 ZNANSTVENI ZAKLJUČKI
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF FENTANYL- RATIOPHARM 25/ 50/ 75/ 100 µg/ h TTS AND ASSOCIATED NAMES (SEE ANNEX I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA FENTANYL - RATIOPHARM IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
8 GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
10 PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO
the CHMP has recommended the granting of the Marketing Authorisation(s) and the amendment of the Summary of Product Characteristics, labelling and package leaflet which are set out in Annex III for Fentanyl-ratiopharm 25/ 50/ 75/ 100 µg/ h TTS and associated names (see Annex I).
CHMP priporočil podelitev dovoljenj( a) za promet in dopolnitev povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo, kot je podano v Dodatku III za zdravilo Fentanyl - ratiopharm in z njim povezana imena (glejte Dodatek I).
9 ANNEX III
11 DODATEK III
10 SUMMARY OF PRODUCT CHARACTERISTICS
12 POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Fentanyl-ratiopharm 25 µg/ h TTS and associated names (see Annex I)
Fentanyl- ratiopharm 25 µg/ h TTS in povezana imena (glejte dodatek I)
Table 1:
14 Preglednica 1:
Recommended initial dose of transdermal fentanyl based on daily oral morphine dose (for patients who have a need for opioid rotation)
Transdermalno sproščanje fentanila (mikrogrami/ h)
Oral morphine
Preglednica 3:
dose (mg/ 24 h)
Peroralni odmerek morfina (mg/ 24h)
Table 3:
150- 209
< 60
75
60-89 90-149 150-209 210-269 270-329 330-389 390-449 450-509 510-569 570-629 630-689
210- 269 270- 329 330- 389 390- 449 450- 509 510- 569 570- 629 630- 689 690- 749
25 50 75 100 125 150 175 200 225 250 275 13
100 125 150 175 200 225 250 275 300
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.
Prior to application, the skin should be carefully washed with clean water (no cleaning agents) and thoroughly dried.
16 Pred uporabo obliža morate kožo umiti le s čisto vodo (brez katerih koli čistilnih sredstev) in jo osušiti.
A period of 7 days
Isti predel kože lahko znova uporabite šele po 7- dnevnem premoru.
The most common adverse reactions following administration at usual doses are drowsiness, confusion, nausea, vomiting and constipation.
17 Najpogostejši neželeni učinki po običajnih odmerkih so zaspanost, zmedenost, slabost, bruhanje in zaprtje.
15 Respiratory depression As with all potent opioids some patients may experience respiratory depression with Fentanyl- ratiopharm, and patients must be observed for this effect.
Respiratorna depresija Fentanyl- ratiopharm lahko, tako kot drugi močni opioidi, povzroči respiratorno depresijo.
Patients with fever/ external heat Significant increases in body temperature can potentially increase fentanyl absorption rate.
18 Ob znatnem zvišanju telesne temperature se lahko poveča hitrost absorbcije fentanila.
16 Due to limited experience in children under 12 years of age, Fentanyl-ratiopharm should be used in this age group only after careful consideration has been given to the benefit versus risk ratio.
Pediatrični bolniki Zaradi omejenih izkušenj uporabe Fentanyl- ratiopharm pri otrocih mlajših od 12 let ne priporočamo, razen v primerih pazljivega ovrednotenja razmerja med koristmi in tveganji zdravljenja.
Lactation As fentanyl is excreted into breast milk, lactation should be discontinued under treatment with Fentanyl-ratiopharm (see also section 4.6).
Dojenje Ker fentanil prehaja v materino mleko je potrebno dojenje med zdravljenjem z obliži Fentanyl - ratiopharm prekiniti (glejte poglavje 4. 6).
Itraconazole (a potent CYP3A4 inhibitor) at 200 mg/ day given orally for four days had no significant effect on the pharmacokinetics of intravenous fentanyl.
19 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.
17 4.6 Pregnancy and lactation
Nosečnost in dojenje
respiratory depression, apnoea.
prsnega koša in mediastinalnega prostora dispneja, hipoventilacija respiratorna depresija, apneja 20
18 Very common: sweating, pruritus.
Bolezni kože in podkožja Zelo pogosti: potenje, pruritus Pogosti:
A starting dose of 0.4-2 mg naloxone hydrochloride i. v. is recommended for adults.
21 Priporočamo intravensko dajanje nalokson klorida v začetnem odmerku od 0, 4 do 2 mg (pri odraslih).
Pharmacokinetics in special groups Elderly and debilitated patients may have reduced clearance of fentanyl leading to prolonged terminal half life.
22 Farmakokinetika pri posebnih skupinah bolnikov Pri starejših in oslabelih bolnikih je očistek fentanila lahko zmanjšan; zdravilo ima zato daljšo razpolovno dobo.
20 Long-term carcinogenicity studies have not been performed.
Dolgoročnih študij kancerogenosti niso opravili.
High quantities of fentanyl remain in the transdermal patches even after use.
23 Visoke količine fentanila ostajajo v transdermalnih obližih tudi po uporabi.
Fentanyl-ratiopharm 50 µg/ h TTS and associated names (see Annex I)
Fentanyl- ratiopharm 50 µg/ h TTS in povezana imena (glejte dodatek I)
The corresponding fentanyl dosage should be determined as follows: a) using Table 2 for patients who have a need for opioid rotation (conversion ratio of oral morphine to transdermal fentanyl equal to150:1) b) using Table 3 for patients on stable and well tolerated opioid therapy (conversion ratio of oral morphine to transdermal fentanyl equal to 100:1)
Odmerek fentanil določite na naslednji način: a) s preglednico 2 za bolnike s potrebo menjavanja zdravljenja z opioidi (delež pretvorbe peroralnega morfina v transdermalni fentanil je enak 150: 1) b) s preglednico 3. za stabilne bolnike, ki dobro prenašajo zdravljenje z opioidi (delež pretvorbe peroralnega morfina v transdermalni fentanil je enak 100: 1)
23 Table 1:
25 Preglednica 1:
Prior to application, the skin should be carefully washed with clean water (no cleaning agents) and thoroughly dried.
27 Pred uporabo obliža morate kožo umiti le s čisto vodo (brez katerih koli čistilnih sredstev) in jo osušiti.
The most common adverse reactions following administration at usual doses are drowsiness, confusion, nausea, vomiting and constipation.
28 Najpogostejši neželeni učinki po običajnih odmerkih so zaspanost, zmedenost, slabost, bruhanje in zaprtje.
Patients with fever/ external heat Significant increases in body temperature can potentially increase fentanyl absorption rate.
29 Ob znatnem zvišanju telesne temperature se lahko poveča hitrost absorbcije fentanila.
Itraconazole (a potent CYP3A4 inhibitor) at 200 mg/ day given orally for four days had no significant effect on the pharmacokinetics of intravenous fentanyl.
30 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.
respiratory depression, apnoea.
prsnega koša in mediastinalnega prostora dispneja, hipoventilacija respiratorna depresija, apneja 31
A starting dose of 0.4-2 mg naloxone hydrochloride i. v. is recommended for adults.
32 Priporočamo intravensko dajanje nalokson klorida v začetnem odmerku od 0, 4 do 2 mg (pri odraslih).
30 5.1 Pharmacodynamic properties
Farmakodinamične lastnosti
Pharmacokinetics in special groups Elderly and debilitated patients may have reduced clearance of fentanyl leading to prolonged terminal half life.
33 Farmakokinetika pri posebnih skupinah bolnikov Pri starejših in oslabelih bolnikih je očistek fentanila lahko zmanjšan; zdravilo ima zato daljšo razpolovno dobo.
High quantities of fentanyl remain in the transdermal patches even after use.
34 Visoke količine fentanila ostajajo v transdermalnih obližih tudi po uporabi.
Fentanyl-ratiopharm 75 µg/ h TTS and associated names (see Annex I)
Fentanyl- ratiopharm 75 µg/ h TTS in povezana imena (glejte dodatek I)
Table 1:
36 Preglednica 1:
25 50 75 100 125 150 175 200 225 250 275 35
100 125 150 175 200 225 250 275 300
Prior to application, the skin should be carefully washed with clean water (no cleaning agents) and thoroughly dried.
38 Pred uporabo obliža morate kožo umiti le s čisto vodo (brez katerih koli čistilnih sredstev) in jo osušiti.
The most common adverse reactions following administration at usual doses are drowsiness, confusion, nausea, vomiting and constipation.
39 Najpogostejši neželeni učinki po običajnih odmerkih so zaspanost, zmedenost, slabost, bruhanje in zaprtje.
37 Respiratory depression As with all potent opioids some patients may experience respiratory depression with Fentanyl- ratiopharm, and patients must be observed for this effect.
Respiratorna depresija Fentanyl- ratiopharm lahko, tako kot drugi močni opioidi, povzroči respiratorno depresijo.
Patients with fever/ external heat Significant increases in body temperature can potentially increase fentanyl absorption rate.
40 Ob znatnem zvišanju telesne temperature se lahko poveča hitrost absorbcije fentanila.
38 Due to limited experience in children under 12 years of age, Fentanyl-ratiopharm should be used in this age group only after careful consideration has been given to the benefit versus risk ratio.
Pediatrični bolniki Zaradi omejenih izkušenj uporabe Fentanyl- ratiopharm pri otrocih mlajših od 12 let ne priporočamo, razen v primerih pazljivega ovrednotenja razmerja med koristmi in tveganji zdravljenja.
Itraconazole (a potent CYP3A4 inhibitor) at 200 mg/ day given orally for four days had no significant effect on the pharmacokinetics of intravenous fentanyl.
41 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.
39 4.6 Pregnancy and lactation
Nosečnost in dojenje
respiratory depression, apnoea.
prsnega koša in mediastinalnega prostora dispneja, hipoventilacija respiratorna depresija, apneja 42
40 Very common: sweating, pruritus.
Bolezni kože in podkožja Zelo pogosti: potenje, pruritus Pogosti:
A starting dose of 0.4-2 mg naloxone hydrochloride i. v. is recommended for adults.
43 Priporočamo intravensko dajanje nalokson klorida v začetnem odmerku od 0, 4 do 2 mg (pri odraslih).
Pharmacokinetics in special groups Elderly and debilitated patients may have reduced clearance of fentanyl leading to prolonged terminal half life.
44 Farmakokinetika pri posebnih skupinah bolnikov Pri starejših in oslabelih bolnikih je očistek fentanila lahko zmanjšan; zdravilo ima zato daljšo razpolovno dobo.
42 Long-term carcinogenicity studies have not been performed.
Dolgoročnih študij kancerogenosti niso opravili.
High quantities of fentanyl remain in the transdermal patches even after use.
45 Visoke količine fentanila ostajajo v transdermalnih obližih tudi po uporabi.
Fentanyl-ratiopharm 100 µg/ h TTS and associated names (see Annex I)
Fentanyl- ratiopharm 100 µg/ h TTS in povezana imena (glejte dodatek I)
Table 1:
47 Preglednica 1:
25 50 75 100 125 150 175 200 225 250 275 46
100 125 150 175 200 225 250 275 300
Prior to application, the skin should be carefully washed with clean water (no cleaning agents) and thoroughly dried.
49 Pred uporabo obliža morate kožo umiti le s čisto vodo (brez katerih koli čistilnih sredstev) in jo osušiti.