natgillin/translations-raw huggingface dataset:
Indehaveren af markedsføringstilladelsen gennemfører sin risikostyringsplan som meddelt CHMP på CHMP’ s møde i maj 2005 og angivet i svaret på vurderingsrapporten den 10. maj 2005.
To undertaking its risk management plan as communicated to the CHMP during May 2005 CHMP meeting and outlined in the assessment report response on 10 May 2005.
38
44
FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKER, INDGIVELSESVEJ, ANSØGERE OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE Medlemsstat
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State
Indehaver af markedsføringstillade lse
Pharmaceutical
Lægemiddelfor Indgivelsesvej m
administration
3, 89079 Ulm, Tyskland
3, 89079 Ulm, Germany
depotplaster transdermal anvendelse
transdermal patch
4. 125 mg/ 7. 5 cm² som frigiver 25 mikrogram per time
4.125 mg/ 7.5 cm² which release 25 µg fentanyl per hour
8. 25 mg/ 15 cm² som frigiver 50 mikrogram per time
8.25 mg/ 15 cm² which release 50 µg fentanyl per hour
12. 375 mg/ 22. 5 cm² som frigiver 75 mikrogram per time
12.375 mg/ 22.5 cm² which release 75 µg fentanyl per hour
16. 5 mg/ 30 cm² som frigiver 100 mikrogram per time
16.5 mg/ 30 cm² which release 100 µg fentanyl per hour
depotplaster
transdermal patch
transdermal anvendelse
transdermal use
Gasse 3, 1140 WIEN, Matrixpflaster Østrig Østrig
Gasse 3, 1140 WIEN, Matrixpflaster Austria Austria
ratiopharm Arzneimittel Vertriebs -
ratiopharm Arzneimittel Vertriebs- GmbH
Fentanyl - ratiopharm 75
Fentanyl- ratiopharm 75 µg/ h
12. 375 mg/ 22. 5 cm² som frigiver 75
12.375 mg/ 22.5 cm² which release 75 µg fentanyl per hour
GmbH Albert- Schweitzer - Gasse 3, 1140 WIEN, Østrig
Albert-Schweitzer- Gasse 3, 1140 WIEN, Austria
µg/ h transdermales Matrixpflaster
transdermales Matrixpflaster
ratiopharm Arzneimittel Vertriebs - GmbH Albert- Schweitzer - Gasse 3, 1140 WIEN, Østrig
ratiopharm Arzneimittel Vertriebs- GmbH Albert-Schweitzer- Gasse 3, 1140 WIEN, Austria
ratiopharm Nederland bv Ronde Tocht 11, 1507 CC Zaandam, Nederlandene
ratiopharm Nederland bv Ronde Tocht 11, 1507 CC Zaandam, The Netherlands
ratiopharm Nederland bv
ratiopharm Nederland bv Ronde Tocht 11, 1507
Fentanyl ratiopharm 50
Fentanyl ratiopharm 50 µg/ uur, pleister
8. 25 mg/ 15 cm² som frigiver 50
8.25 mg/ 15 cm² which release 50 µg fentanyl per hour
Ronde Tocht 11, 1507 CC Zaandam, Nederlandene
CC Zaandam, The Netherlands
µg/ uur, pleister voor transdermaal gebruik
voor transdermaal gebruik
4 Spanien
Spain
Fentanilo Matrix ratiopharm 100 microgramos/ h parches transdérmicos EFG
Fentanilo Matrix
depotplaster
transdermal
16. 5 mg/ 30 cm² som frigiver 100 mikrogram per time
which release 100 µg fentanyl per hour
FAGLIGE KONKLUSIONER OG BEGRUNDELSE FOR ÆNDRING AF PRODUKTRESUMÉET (- RESUMÉERNE), ETIKETTERINGEN OG INDLÆGSSEDLEN FREMLAGT AF EMEA
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
SAMMENDRAG AF DEN FAGLIGE VURDERING AF FENTANYL "RATIOPHARM" OG TILKNYTTEDE NAVNE (SE BILAG I)
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF FENTANYL- RATIOPHARM AND ASSOCIATED NAMES (SEE ANNEX I)
4, i direktiv 2001/ 83/ EF vedrørte uenighed om følgende punkter:
The points of disagreement leading to this referral procedure under Article 29(4) of Directive 2001/ 83/ EC pertained to:
1 - Den påtænkte udvidelse af den terapeutiske indikation til andre svære kroniske smerter end cancersmerter 2 - Hvilke( n) omregningstabel( ler), der skal indgå i produktresuméet 3 - Hvorvidt amning og sideløbende brug af opioider af typen partielle agonister bør være kontraindiceret 4 - Kravet om, at bioækvivalensundersøgelserne påviser ækvivalens med referenceproduktet
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 contra- indicated 4- The bioequivalence studies needed to demonstrate the equivalence with the reference product
I denne forbindelse godtog CHMP indikationen "Svære kroniske smerter, hvor kun opioidanalgetika har tilfredsstillende virkning".
In this context, the CHMP accepted the indication “ Severe chronic pain which can be adequately managed only with opioid analgesics”.
"Ved andre kroniske smerter end cancersmerter kan det være hensigtsmæssigt at indlede behandlingen med stærkt virkende opioider med umiddelbar frigivelse (f. eks. morphin) og først ordinere fentanyl depotplaster, efter at virkning og optimal dosering af stærkt virkende opioder er fastlagt."
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 .”
Vedrørende de i produktresuméet angivne tabeller til omregning af dosis fra oral morphin til fentanyl er det ud fra de foreliggende oplysninger CHMP' s opfattelse, at begge tabeller bør være indeholdt i produktresuméet (pkt.
Regarding the dose conversion schemes provided in the SPC from oral morphine to transdermal fentanyl, the CHMP, based on the available data, is of the opinion that both tables should be mentioned in the SPC (section 4.2).).
I produktresuméet for Fentanyl "ratiopharm" angives det forsigtigt skønnede omregningsforhold (150: 1) for patienter med behov for opioid- rotation og 100: 1 (Donners tabel) for patienter i stabil, veltolereret opioidbehandling.
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.
"Fentanyl udskilles med modermælk og kan medføre sedation og respirationsdepression hos det ammede barn.
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 breast- fed infant.
Amning bør der derfor tidligst finde sted 72 timer efter aftagning af fentanyl depotplasteret "Produktet kan altså anvendes af ammende mødre, men amning bør ophøre under brug af plasteret og 72 timer efter.
Lactation should therefore be discontinued for at least 72 hours after the removal of fentanyl transdermal patch” 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.
4. 6 og ikke anføres som en kontraindikation.
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.
4. 4 i produktresuméet: ….
In addition, the CHMP recommends including the following information in section 4.4 of the SPC: ….
4. 6) ….
Lactation As fentanyl is excreted into breast milk, lactation should be discontinued under the treatment with fentanyl (see also section 4.6) ….
Vedrørende anvendelse samtidig med andre opioider erkendes det, at der ved kombination af fentanyl med en partiel agonist/ antagonist som buprenorphin, nalbuphin eller pentazocin for det første er risiko for nedsat analgetisk virkning på grund af kompetitive antagonistiske virkninger, for det andet for abstinenssyndrom, der ligeledes er en alvorlig tilstand.
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.
7 Fra et klinisk synspunkt repræsenterer dette dog kun en mindre risiko for patienter i transdermal smertebehandling med fentanyl i sædvanlig dosis.
7 However, from the clinical point of view, this aspect represents only a minor risk for patients receiving transdermal fentanyl pain therapy in average doses.
4. 4 "sideløbende anvendelse anbefales ikke" i stedet for som en kontraindikation.
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.
Hvad endelig angår påvisning af bioækvivalens vedrørte drøftelserne afvigelserne fra guidelinen "Note for guidance on modified release oral and trans- dermal dosage forms: section II: pharmacokinetic and clinical evaluation (CPMP/ EWP/ 280/ 96)".
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 )”.
CHMP finder, at kriterierne i guidelinen for transdermale doseringsformer − CPMP/ EWP/ 280/ 96 − (dvs. eksakt proportionalitet af formuleringen og acceptabel in vitro- udløsningsprøve) opfyldes både af Fentanyl "ratiopharm" og af referenceproduktet.
The CHMP considers that the criteria of the guideline on transdermal dosage forms - CPMP/ 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.
En undersøgelse, hvor der anvendes den højeste dosis (100 µg i timen), vil desuden kun kunne gennemføres på intensivafdelinger og vil kræve sideløbende behandling med opioidantagonister (naltrexon) for at undgå livstruende bivirkninger.
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.
Hvis en sådan undersøgelse skulle udføres i EU, ville styrken 50 µg/ time sædvanligvis blive anbefalet.
As a general rule in EU, if such a study would have to be conducted, the 50 µg/ h strength would be recommended.
Biostatistisk analyse af denne undersøgelse kan muligvis være velegnet til at vurdere den intra- individuelle variation og betydningen af de forskellige udløsningssystemers biofarmaceutiske funktion (reservoir kontra matrix).
The biostatistical evaluation of the existing single dose study with replicate design (but showing non- bioequivalence) 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).
CHMP fandt også bioækvivalensen mellem testproduktet og referenceproduktet tilstrækkelig velkarakteriseret i de to undersøgelser (med enkeltdosering og gentagen dosering), hvor der blev anvendt en reduceret plasterstørrelse (7, 5 cm²).
The CHMP considered also that bioequivalence between test and reference medicinal product has been sufficiently characterised in 2 studies (single and multiple dose) performed with a reduced patch size (7.5 cm²).
Hverken en bioækvivalensundersøgelse med den højeste styrke eller en supplerende undersøgelse med gentagelser anses derfor for nødvendig.
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.
8 BEGRUNDELSE FOR ÆNDRINGEN AF PRODUKTRESUMÉET, ETIKETTERINGEN OG INDLÆGSSEDLEN
8 GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Eftersom indbringelsen vedrørte:
Whereas
- mulige sundhedsmæssige betænkeligheder i forbindelse med udvidelsen af den kliniske
- the scope of the referral was the potential public health concerns regarding the extension of the
indikation
clinical indication
- påvisning af bioækvivalens med referenceproduktet og
- the demonstration of the bioequivalence with the reference product,
- harmonisering af produktresuméet, etiketteringen og indlægssedlen,
- and the harmonisation of the Summary of Product Characteristics, labelling and package leaflet,
anbefalede CHMP på grundlag af den dokumentation, der er forelagt af indehaveren af markedsføringstilladelsen, og den faglige drøftelse i udvalget udstedelse af de markedsføringstilladelse( r) og ændring af det produktresumé og den etikettering og indlægsseddel, der fremgår af bilag III, for Fentanyl "ratiopharm" og tilknyttede navne – se bilag I.
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 and associated names (see Annex I).
10 PRODUKTRESUME
10 SUMMARY OF PRODUCT CHARACTERISTICS
Fentanyl- ratiopharm 25 µg/ h Matrixpflaster og andre berørte navne (se Vedlæg I)
Fentanyl-ratiopharm 25 µg/ h Matrixpflaster and associated names (see Annex I)
1 depotplaster frigiver 25 mikrogram fentanyl i timen.
Each patch releases 25 micrograms fentanyl per hour.
1 plaster på 7, 5 cm2 indeholder 4, 125 mg fentanyl.
Each patch of 7.5 cm2 contains 4.125 mg fentanyl.
Transparent og farveløst plaster med blåt tryk på bagsidefolien: “ fentanyl 25 µg/ h “.
Transparent and colourless patch with blue imprint on the backing foil: “ fentanyl 25 µg/ h“.
Doseringen individualiseres ud fra den enkelte patients tidligere opioidbehandling under hensyntagen til • mulig udvikling af tolerans • patientens aktuelle almentilstand og medicinske status • sygdommens sværhedsgrad.
The dosing is individual and based on the patient’ s opioid history and takes into account: • the possible development of tolerance, • the current general condition, the medical status of the patient, and • the degree of severity of the disorder.
Patienter, der får opioidbehandling for første gang Der foreligger plastre med en frigivelseshastighed på 12, 5 mikrogram i timen, og de bør anvendes til indledning af behandlingen.
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.
Hos gamle eller svagelige bør opioidbehandling ikke indledes med Fentanyl - ratiopharm, da denne patientgruppe er kendt for at være meget modtagelig over for opioider.
In very elderly or weak patients, it is not recommended to initiate an opioid treatment with Fentanyl- ratiopharm, due to their known susceptibility to opioid treatments.
I så fald skal behandlingen fortrinsvis indledes med lave doser af et morphinpræparat med konventionel udløsning, og Fentanyl- ratiopharm gives først, når den optimale dosering er fastlagt.
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.
Ved skift fra andre opioider Den initiale dosis ved overgang fra perorale eller parenterale opioider til behandling med fentanyl beregnes som følger:
Switching from other opioids When changing over from oral or parenteral opioids to fentanyl treatment, the initial dosage should be calculated as follows:
Den tilsvarende fentanyldosis fastsættes som følger: a) Ved hjælp af tabel 2 for patienter, som har behov for opioidrotation (med konvertering fra peroralt morphin til transdermalt fentanyl i forholdet 150: 1) b) Ved hjælp af tabel 3 for patienter på stabil og veltolereret opioidterapi (med konvertering fra peroralt morphin til transdermalt fentanyl i forholdet 100: 1)
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)
Ækvianalgetiske doser ved konvertering Alle de i tabellen opgivne doseringer har en analgetisk virkning svarende til 10 mg parenteralt morphin.
Equianalgesic potency conversion All dosages given in the table are equivalent in analgesic effect to 10 mg parenteral morphine.
Ækvianalgetiske doser (mg) Aktivt stof Morphin Hydromorphon Oxycodon Methadon Levorphanol Oxymorphin Diamorphin Pethidin Codein Buprenorphin Ketobemidon
Equianalgesic doses (mg) Active substance Parenteral (im) Oral Morphine Hydromorphone Oxycodone Methadone Levorphanol Oxymorphine Diamorphine Pethidine Codeine Buprenorphine Ketobemidone
Parenteralt (i. m.) 10 1, 5 10- 15 10 2 1 5 75 - 0, 4 10
10 1.5 10-15 10 2 1 5 75 - 0.4 10
Peroralt 30- 40 7, 5 20- 30 20 4 10 (rektalt) 60 - 200 0, 8 (sublingualt) 20- 30
30-40 7.5 20-30 20 4 10 (rectal) 60 - 200 0.8 (sublingual) 20-30
Anbefalet initialdosis af transdermalt fentanyl ud fra daglig peroral morphindosis (for patienter med behov for opioidrotation)
Recommended initial dose of transdermal fentanyl based on daily oral morphine dose (for patients who have a need for opioid rotation)
Peroral morphindosis (mg/ døgn)
dose (mg/ 24 h) < 44
Transdermal frigivelse af fentanyl (mikrogram/ time)
Transdermal fentanyl release (micrograms/ h) 12.5
< 44 0- 134 135- 224 225- 314 315- 404 405- 494 495- 584 585- 674 675- 764 765- 854 855- 944 945- 1034 1035- 1124
315-404 405-494 495-584 585-674 675-764 765-854 855-944
13 Tabel 3:
Table 3:
Anbefalet initial dosis af transdermalt fentanyl baseret på daglig peroral morphindosis (for patienter på stabil og veltolereret opioidterapi)
Recommended initial dose of transdermal fentanyl based on daily oral morphine dose (for patients on stable and well tolerated opioid therapy)
Peroral morphindosis (mg/ døgn) < 60
Oral morphine dose (mg/ 24 h) < 60
Transdermal frigivelse af fentanyl (mikrogram/ time) 12, 5
Transdermal fentanyl release (micrograms/ h) 12.5
60- 89 90- 149 150- 209 210- 269 270- 329 330- 389 390- 449 450- 509 510- 569 570- 629 630- 689 690- 749
60-89 90-149 150-209 210-269 270-329 330-389 390-449 450-509 510-569 570-629 630-689 690-749
25 50 75 100 125 150 175 200 225 250 275 300
25 50 75 100 125 150 175 200 225 250 275 300
Ved at kombinere flere depotplastre kan der opnås en frigivelseshastighed for fentanyl på over 100 mikrogram i timen.
13 By combining several transdermal patches, a fentanyl release rate of over 100 micrograms/ h can be achieved.
Den indledende evaluering af den maksimale analgetiske virkning af Fentanyl- ratiopharm må ikke finde sted, før plasteret har været i brug i 24 timer.
The initial evaluation of the maximum analgesic effect of Fentanyl-ratiopharm should not be made before the patch has been worn for 24 hours.
I de næste 12 timer administreres dette analgetikum efter behov.
In the first 12 hours after changing to Fentanyl-ratiopharm the patient continues to receive the previous analgesic at the previous dose; over the next 12 hours this analgesic is administered according to need.
Dosistitrering og vedligeholdelsesbehandling Plasteret bør skiftes hver 72. time.
Dose titration and maintenance therapy The patch should be replaced every 72 hours.
Det kan være nødvendigt at skifte depotplasteret efter 48 timer hos patienter, som oplever et markant fald 48- 72 timer efter applikation.
In patients who experience a marked decrease in the period 48-72 hours after application, replacement of fentanyl after 48 hours may be necessary.
Der foreligger plastre med en frigivelseshastighed på 12, 5 mikrogram i timen, som er egnet til dosistitrering i det lave dosisområde.
Patches with a release rate of 12.5 micrograms/ hour are available and are appropriate for dose titration in the lower dosage area.
Yderligere dosisjustering bør normalt foretages med dosisintervaller på 25 mikrogram i timen, idet der dog bør tages højde for patientens behov for yderligere analgesi og smertestatus.
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.
Yderligere eller alternative metoder til analgesi eller alternativ administration af opioider bør overvejes, når doseringen af Fentanyl- ratiopharm overstiger 300 mikrogram/ time.
Additional or alternative methods of analgesia or alternative administration of opioids should be considered when the Fentanyl-ratiopharm dose exceeds 300 micrograms/ hour.
Ændring eller afslutning af behandlingen Hvis det er nødvendigt at seponere plasteret, bør det gradvist erstattes af andre opioider, idet der indledes med en lav dosis, som langsomt øges.
Changing or ending therapy If discontinuation of the patch is necessary, any replacement with other opioids should be gradual, starting at a low dose and increasing slowly.
Dette er nødvendigt, fordi fentanylniveauet aftager gradvist, når plasteret fjernes, og det tager mindst 17 timer at få halveret fentanyls serumkoncentration.
This is because fentanyl levels fall gradually after the patch is removed; it takes at least 17 hours for the fentanyl serum concentration to decrease by 50%.
14 Umiddelbart efter det er taget ud af pakningen og beskyttelsesfolien er fjernet, anbringes depotplasteret på et hårløst område af huden på overkroppen (bryst, ryg eller overarm).
Method of administration 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).
Dernæst anbringes depotplasteret, som trykkes fast med et let tryk med håndfladen i ca. 30 sekunder.
The transdermal patch is then applied using slight pressure with the palm of the hand for approximately 30 seconds.
Hudområdet, hvor plasteret anbringes, skal være uden småsår (fx på grund af strålebehandling eller barbering) og hudirritation.
The skin area to which the patch is applied should be free of microlesions (e. g. due to irradiation or shaving) and skin irritation.
Behandlingens varighed Plasteret bør skiftes efter 72 timer.
Duration of administration The patch should be changed after 72 hours.
Hvis der er spor af plasteret på huden, efter at det er taget af, kan de fjernes med rigeligt vand og sæbe.
14 If traces of the transdermal patch remain on the skin after its removal, these can be cleaned off using copious amounts of soap and water.
Erfaring med behandling af børn under 12 år er begrænset.
Paediatric population The experience in children under 12 years of age is limited.
Fentanyl- ratiopharm depotplaster må ikke anvendes til denne population.
Fentanyl-ratiopharm should not be used in this population.
4. 4 og 5. 2).
Use in elderly patients Elderly should be observed carefully and the dose reduced if necessary (see sections 4.4 and 5.2).
4. 4).
Hepatic and renal impairment Patients with hepatic or renal impairment should be observed carefully and the dose reduced if necessary (see section 4.4).
Behandling med Fentanyl- ratiopharm må kun indledes af en erfaren læge, der har kendskab til farmakokinetikken bag fentanyl depotplastre og risikoen for svær hypoventilation.
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.
5. 2).
After exhibiting a serious adverse reaction a patient should be monitored for 24 hours following removal of a transdermal patch due to the half life of fentanyl (see section 5.2).
Ved kroniske smerter, der ikke skyldes cancer, vil det muligvis være bedre at indlede behandlingen med stærke opioider med konventionel udløsning (fx morphin) og at ordinere fentanyl depotplaster efter bestemmelse af effekt og optimal dosering af det stærke opioid.
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.