qanastek/EMEA-V3 huggingface dataset:
Very Rare (occurring in less than 1 out of 10,000 people) Allergic reactions (which may be serious enough to require immediate medical attention) including hives, swelling of the face, lips, tongue, and/ or throat which may cause difficulty in breathing or swallowing, bronchospasm (wheezing or shortness of breath), severe skin reactions, inflammation of the stomach lining or stomach ulcers that can become serious and may lead to bleeding, liver problems, serious kidney problems, severe increase in blood pressure, confusion, seeing, feeling or hearing things that are not there (hallucinations).
Rari Ħafna (li jseħħu f’ inqas minn persuna 1 minn kull 10, 000) Reazzjonijiet allerġiċi (li jistgħu jkunu serji biżżejjed biex ikunu jeħtieġu attenzjoni medika immedjata) inkluż ħorriqija, nefħa tal- wiċċ, xofftejn, ilsien u/ jew gerżuma li jistgħu jikkawżaw diffikultà fit- teħid tan - nifs jew biex wieħed jibla ’, bronkospażmi (tħarħir jew qtugħ ta ’ nifs), reazzjonijiet severi tal- ġilda, infjammazzjoni ta ’ l- inforra ta ’ l- istonku jew ulċeri fl- istonku li jistgħu jsiru serji u jistgħu jwasslu għal fsada, problemi fil- fwied, problemi serji fil- kliewi, żieda severa fil- pressjoni tad- demm, konfużjoni, tara, tħoss u tisma ’ affarijiet li mhumiex hemm (alluċinazzjonijiet).
HOW TO STORE< Etoricoxib >
KIF TAĦŻEN < Etoricoxib >
Do not use< Etoricoxib > after the expiry date which is stated on the pack.
Tużax < Etoricoxib > wara d- data ta ’ skadenza li tidher fuq il- pakkett.
What< Etoricoxib > contains
X’ fih < Etoricoxib >
Core: calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate, microcrystalline cellulose.
41 Qalba: calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate, microcrystalline cellulose.
What< Etoricoxib > looks like and contents of the pack
Id- dehra ta '< Etoricoxib > u l- kontenut tal- pakkett
< Etoricoxib > Tablets are available in four strengths:
Il- Pilloli ta ’ < Etoricoxib > jiġu f’ erba ’ qawwiet:
41 60 mg dark green, apple-shaped, biconvex film coated tablets marked ‘ ARCOXIA 60’ on one side and ‘ 200’ on the other.
60 mg pilolli miksijin b’ rita ġejjin għat- tond miż- żewġ naħat, f’ għamla ta ’ tuffieħa, blu- ħodor immarkati ‘ ARCOXIA 60 ’ fuq naħa u b ’ ‘ 200 ’ fuq in- naħa l- oħra.
This medicinal product is authorized in the Member States of the EEA under the following names:
Dan il- prodott mediċinali huwa awtorizzat fl- Istati Membri taż- ŻEE bl- ismijiet li ġejjin:
Bulgaria Czech Rep.
Il- Bulgarija Ir- Rep.
Cyprus Denmark Estonia Finland
ĊEKA Ċipru Id- Danimarka L- Estonja Il- Finlandja
Malta Netherlands
Franza Il- Ġermanja
ARCOXIA 30, 60, 90 or 120 mg film-coated tablets Arcoxia 30 mg, 60 mg, 90 mg, 120 mg
Arcoxia 30 mg, comprimé pelliculé ARCOXIA 30/ 60/ 90/ 120 mg Filmtabletten;
Auxib 30 mg, 60 mg, 90 mg, 120 mg Norway Poland Portugal
ARCOXIA 30, 60, 90 or 120 mg film- coated tablets Arcoxia 30 mg, 60 mg, 90 mg, 120 mg Auxib 30 mg, 60 mg, 90 mg, 120 mg
Romania Slovakia Slovenia Spain
Ir- Rumanija Is- Slovakja Is- Slovenja Spanja
This leaflet was last approved in (MM/ YYYY).
Dan il- fuljett kien approvat l- aħħar f '(XX/ SSSS).
44 CONDITIONS OF THE MARKETING AUTHORISATION
44 KUNDIZZJONJIET TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
National competent authorities (NCA) shall ensure that the following conditions are fulfilled by the marketing authorisation holders:
Awtoritajiet kompetenti nazzjonali (NCA) għandhom jiżguraw li l- kundizzjonijiet li ġejjin huma ssodisfatti mid- detenturi ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
- A direct healthcare professional communication (DHPC) must be sent to all healthcare professionals
- Komunikazzjoni diretta mal- professjonisti tal- kura tas- saħħa (DHPC) jeħtieġ li tintbagħat lill -
who prescribe etoricoxib according to national practice.
professjonisti tal- kura tas- saħħa kollha li jagħtu etoricoxib fuq riċetta skond il- prattika nazzjonali.
This information should inform healthcare professionals on the cardiorenal risks associated with etoricoxib and should be in line with the DHPC endorsed by the CHMP.
Dan it - tagħrif għandu jinforma lill- professjonisti tal- kura tas- saħħa dwar ir- riskji kardjorenali b’ etoricoxib u għandu jkun konformi mad- DHPC approvata mis- CHMP.
London, 23 October 2008 EMEA/ 542169/ 2008
Londra, 23 ta ’ Ottubru 2008 EMEA/ CHMP/ 620036/ 2008
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 31(2) REFERRAL
OPINJONI TAL- KUMITAT GĦALL- PRODOTTI MEDIĊINALI GĦALL- UŻU MILL - BNIEDEM SKONT REFERENZA MILL- ARTIKOLU 31( 2)
Etoricoxib containing medicinal products
Prodotti mediċinali li fihom etoricoxib
Etoricoxib is a selective inhibitor of COX-2 (cyclooxygenase 2) indicated in the symptomatic relief of osteoarthritis (OA, 30-60mg once daily (od)), rheumatoid arthritis (RA, 90mg od) and the pain and signs of inflammation associated with acute gouty arthritis (120mg od).
Etoricoxib huwa inibitur selettiv ta ’ COX- 2 (cyclooxygenase 2) indikat fis- serħan sintomattiv ta ’ osteoartrite (OA, 30- 60mg darba kuljum (od)), artrite rewmatojde (RA, 90mg od) u l- uġigħ u s- sinjali ta ’ infjammazzjoni assoċjati ma ’ artrite tal- gotta akuta (120mg od).
This referral procedure relates to a request for arbitration concerning the benefit/ risk of the 90mg dose of etoricoxib in the treatment of RA and ankylosing spondylitis (AS).
Din il- proċedura ta ’ referenza għandha x’ taqsam ma ’ talba għall- arbitraġġ dwar il- benefiċċju/ riskju tad- doża ta ’ 90 mg ta ’ etoricoxib fil- kura ta ’ RA u ankylosing spondylitis (AS).
At the end of the mutual recognition procedure for the variation to extend the indication to include AS, there was a discrepancy between different European Union (EU) Member States regarding the safety of etoricoxib at the 90mg dose.
Fl- aħħar tal- proċedura ta ’ rikonoxximent reċiproku għall- varjazzjoni biex l- indikazzjoni tiġi estiża sabiex tinkludi AS, kien hemm diskrepanza bejn Stati Membri differenti tal- Unjoni Ewropea (UE) fir - rigward tas- sigurtà ta ’ etoricoxib f’ doża ta ’ 90mg.
As these concerns were not resolved during the course of the procedure, and since the 90mg dose of etoricoxib was used in both RA and AS, a notification of an official referral for arbitration under Article 31(2) of Directive 2001/ 83, as amended to the CHMP was made by France on 19 September 2007.
Minħabba li dan it- tħassib ma kienx solvut waqt il - kors tal- proċedura, u minħabba li d- doża ta ’ 90mg ta ’ etoricoxib intużat kemm f’ RA kif ukoll f’ AS, fid- 19 ta ’ Settembru 2007 saret notifikazzjoni lis- CHMP min- naħa ta ’ Franza fir- rigward ta ’ referenza uffiċjali għal arbitraġġ skont l- Artikolu 31( 2) tad- Direttiva 2001/ 83 kif emendata.
The main unresolved areas of concern identified by France were concerns regarding long term safety of a daily dose of 90mg etoricoxib in the view of possible increased cardiovascular (CV) risk related to the use of the 90mg dose in the RA and AS indications.
L- oqsma ta ’ tħassib ewlenin mhux solvuti identifikati minn Franza kienu tħassib fir- rigward tas - sigurtà fit- tul ta ’ doża ta ’ kuljum ta ’ 90mg etoricoxib mil- lat ta ’ żieda possibbli fir- riskju kardjovaskulari (KV) relatat mal- użu ta ’ 90mg fl- indikazzjonijiet ta ’ RA u ta ’ AS.
France considered that a review of the benefit/ risk profile of etoricoxib containing medicinal products was of Community interest.
Franza kkunsidrat li reviżjoni tal- profil benefiċċju/ riskju ta ’ prodotti mediċinali li fihom etoricoxib kienet ta ’ interess għall - Komunità.
The arbitration procedure was discussed by the CHMP at its plenary meeting in September 2007 and a Rapporteur (Dr.
Il- proċedura ta ’ arbitraġġ kienet diskussa mis- CHMP fil- laqgħa plenarja tiegħu f’ Settembru 2007 u nħatru Rapporteur (Dr.
Karl Broich) and Co-Rapporteur (Dr.
Karl Broich) u Co- Rapporteur (Dr.
The referral procedure was initiated on 20 September 2007 with the adoption of a CHMP list of questions that were to be addressed by the marketing authorisation holders (MAHs).
Il- proċedura ta ’ referenza nbdiet fl- 20 ta ’ Settembru 2007 bl- adozzjoni ta ’ lista ta ’ mistoqsijiet tas- CHMP li kellhom jiġu indirizzati mid- detenturi tal- awtorizzazzjoni għat- tqegħid fis- suq (MAHs).
During the February 2008 plenary meeting Dr.
Waqt il- laqgħa plenarja ta ’ Frar 2008, Dr.
Rafe Survana was appointed Co-Rapporteur, replacing Dr.
Rafe Survana inħatar Co- Rapporteur, u ħa l- post ta ’ Dr.
Written explanations were provided by the MAHs on 14 December 2008, 5 May 2008, 12 June 2008 and 20 June 2008.
Spjegazzjonijiet bil- miktub ingħataw mid- Detenturi ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq fl- 14 ta ’ Diċembru 2008, 5 ta ’ Mejju 2008, 12 ta ’ Ġunju 2008 u fl- 20 ta ’ Ġunju 2008.
The CHMP concluded that the data confirmed the known renovascular safety profile of etoricoxib (hypertension, oedema and congestive heart failure).
Is- CHMP ikkonkluda li d- dejta kkonfermat il- profil ta ’ sigurtà renovaskulari magħruf ta ’ etoricoxib (pressjoni għolja, edema u falliment konġestiv tal- qalb).
The data further confirmed a similar CV thrombotic risk like diclofenac and some degree of upper gastrointestinal (GI) safety advantage over naproxen and diclofenac (though no particular lower GI safety advantage).
Id- dejta kkonfermat ukoll riskju trombotiku KV simili għal diclofenac u xi grad ta ’ vantaġġ ta ’ sigurtà gastrointestinali fil- parti ta ’ fuq (GI) fuq naproxen u diclofenac (madankollu l- ebda vantaġġ partikolari fis- sigurtà GI tan- naħa t’ isfel).
There was little direct comparative safety data for individual non-steroidal anti-inflammatory drugs (NSAIDs) other than diclofenac and naproxen.
Kien hemm ftit dejta tas- sigurtà komparattiva diretta għal mediċini anti- infjammatorji mhux sterojdi individwali (NSAIDs) għajr għal diclofenac u naproxen.
Drug utilisation data showed that some patients with high blood pressure are being initiated on etoricoxib.
Kien għalhekk diffiċli biex jiġu stabbiliti r - riskji għal etoricoxib meta mqabbla ma ’ ibuprofen, ketoprofen u NSAIDs oħrajn mhux daqshekk komunement użati.
Reproduction is authorised provided the source is acknowledged. hypertensive patients and alerts prescribers that blood pressure needs to be monitored, especially within 2 weeks of treatment initiation.
Dejta ta ’ utilizzazzjoni tal- mediċina wriet li xi pazjenti bi pressjoni tad- demm għolja qed jinbdew fuq etoricoxib.
Healthcare professionals were to be reminded of these measures through a communication letter (Dear Healthcare Professional Letter).
Professjonisti fil- qasam tas- saħħa kellhom ikunu mfakkrin fuq dawn il- miżuri permezz ta ’ ittra ta ’ kommunikazzjoni (Ittra Għażiż Professjonist tal- Kura tas- Saħħa).
Data from clinical studies showed clinically meaningful treatment effect for the 90mg etoricoxib once daily dose for both RA and AS indications; however, some data are available to indicate that lower doses might also show effect.
Dejta minn studji kliniċi wriet effett ta ’ kura klinikament sinifikattiv għad- doża ta ’ 90mg etoricoxib darba kuljum kemm għall- indikazzjonijiet RA kif ukoll għall- AS; madankollu hemm xi dejta disponibbli li tindika li dożi iktar baxxi jistgħu wkoll juru effett.
The CHMP therefore recommended that dose finding studies should be explored to conclude if treatment with 60mg once daily would also be adequate for some patients.
Għaldaqstant, is- CHMP irrakkomanda li l- istudji ta ’ tfittix tad- doża għandhom jiġu esplorati biex jiġi konkluż jekk kura b’ 60 mg darba kuljum tkunx ukoll adegwata għal xi pazjenti.
Based on the review of the available data, the CHMP considered that the benefits of etoricoxib outweigh the risks in the treatment of rheumatoid arthritis and ankylosing spondylitis.
Abbażi tar- reviżjoni dwar id- dejta disponibbli, is- CHMP ikkunsidra li l- benefiċċji ta ’ etoricoxib jegħlbu r- riskji fil- kura ta ’ artrite rewmatojde u ta ’ ankylosing spondylitis.
On 26 June 2008, the CHMP, having considered the data provided by the MAHs, recommended the granting of the variation to the marketing authorisations.
Fis- 26 ta ’ Ġunju 2008, wara li kkunsidra d- dejta mogħtija mid- Detenturi ta ’ l- Awtorizzazzjoni għat - Tqegħid fis- Suq, is- CHMP irrakkomanda l- għoti tal- varjazzjoni lill- awtorizzazzjonijiet għat- tqegħid fis- suq.
The list of product names concerned is given in Annex I.
Il- lista ta ’ ismijiet ta ’ prodotti ikkonċernati tingħata f’ Anness I.
The scientific conclusions are provided in Annex II, the amended product information in Annex III and the conditions of the marketing authorisation in Annex IV.
Il- konklużjonijiet xjentifiċi huma mogħtija fl- Anness II, l- informazzjoni emendata tal- prodott fl- Anness III u l- kundizzjonijiet tal - awtorizzazzjoni għat- tqegħid fis- suq fl- Anness IV.
The final opinion was converted into a decision by the European Commission on 9 September 2008.
L- opinjoni finali inbidlet f’ deċiżjoni mill- Kummissjoni Ewropea fid- 9 ta ’ Settembru 2008.
∗ Notes: the information given in this document and its annexes reflects only the CHMP opinion dated 26 June 2008.
∗ Noti: l- informazzjoni mogħtija f’ dan id- dokument u fl- annessi tiegħu tirrifletti biss l- opinjoni tas- CHMP datata 26 ta ’ Ġunju 2008.
The Member States’ competent authorities will continue to keep the product under regular review.
L- awtoritajiet kompetenti tal- Istati Membri se jkomplu jżommu l- prodott taħt reviżjoni regolari.
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
LISTA TA` L- ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWIET TAL- PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, L- APPLIKANTI, ID- DETENTURI TA` L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ FL- ISTATI MEMBRI Stat Membru
Route of
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq
Content
L- Applikant
Name
Isem Ivvintat
Form
Għamla Farmaċewtika
(concentration)
Il- Kontenut (Konċentrat)
3, 89079 Ulm, Germany
3, 89079 Ulm, Il- Ġermanja
transdermal patch
garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda
transdermal use
użu transdermali
4.125 mg/ 7.5 cm² which release 25 µg fentanyl per hour
4. 125 mg/ 7. 5 cm² li terħi 25 µg fentanyl fis- siegħa
8.25 mg/ 15 cm² which release 50 µg fentanyl per hour
8. 25 mg/ 15 cm² li terħi 50 µg fentanyl fis- siegħa
12.375 mg/ 22.5 cm² which release 75 µg fentanyl per hour
12. 375 mg/ 22. 5 cm² li terħi 75 µg fentanyl fis- siegħa
16.5 mg/ 30 cm² which release 100 µg fentanyl per hour
16. 5 mg/ 30 cm² li terħi 100 µg fentanyl fis- siegħa
ratiopharm Arzneimittel Vertriebs- GmbH Albert-Schweitzer-
ratiopharm Arzneimittel Vertriebs - GmbH Albert- Schweitzer - Gasse 3, 1140 WIEN, L- Awstrija
Gasse 3, 1140 WIEN, Matrixpflaster Austria Austria
L- Awstrija
transdermal patch
garża li tipprovdi mediċina li tgħaddi minn
Gasse 3, 1140 WIEN, Matrixpflaster Austria Austria
Gasse 3, 1140 WIEN, L- Awstrija
ratiopharm Arzneimittel Vertriebs- GmbH
ratiopharm Arzneimittel Vertriebs - GmbH Albert- Schweitzer - Gasse 3, 1140 WIEN, L- Awstrija
2
L- Awstrija
Albert-Schweitzer- Gasse 3, 1140 WIEN, Austria
ratiopharm Arzneimittel Vertriebs - GmbH Albert- Schweitzer - Gasse 3, 1140 WIEN, L- Awstrija
transdermales Matrixpflaster
Fentanyl - ratiopharm 100 µg/ h transdermales Matrixpflaster
Austria
100
transdermal patch
garża li tipprovdi
transdermal use
mediċina li tgħaddi minn ġol- ġilda
4.125 mg/ 7.5 cm² which release 25 µg fentanyl per hour
fis- siegħa
3, 89079 Ulm, Germany
3, 89079 Ulm, Il - Ġermanja
The Netherlands
3 L- Olanda
ratiopharm Nederland bv Ronde Tocht 11, 1507 CC Zaandam, The Netherlands
ratiopharm Nederland bv Ronde Tocht 11, 1507 CC Zaandam, L - Olanda
ratiopharm Nederland bv Ronde Tocht 11, 1507
ratiopharm Nederland bv Ronde Tocht 11, 1507 CC Zaandam, L - Olanda
Avenida de Burgos 16D, 5º Planta, 28036 Madrid, Spain
Avenida de Burgos 16D, 5º Planta, 28036 Madrid, Spanja
Fentanilo Matrix ratiopharm 50 microgramos/ h parches transdérmicos EFG
Fentanilo Matrix ratiopharm 50 microgramos/ h parches
Fentanilo Matrix
Fentanilo Matrix ratiopharm 100 microgramos/ h parches transdérmicos EFG
transdermal
garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda
which release 100 µg fentanyl per hour
16. 5 mg/ 30 cm² li terħi 100 µg fentanyl fis- siegħa
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
KONKLUŻJONIJIET XJENTIFIĊI U ARGUMENTI GĦAL EMENDI TAS- SOMMARJU( I) TAL- KARATTERISTIĊI TAL- PRODOTT, TIKKETTA U FULJETT TA ’ TAGĦRIF IPPREŻENTATI MILL- EMEA
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF FENTANYL- RATIOPHARM AND ASSOCIATED NAMES (SEE ANNEX I)
SOMMARJU TOTALI TA ’ L- EVALWAZZJONI XJENTIFIKA TA ’ FENTANYL - RATIOPHARM U ISMIJIET ASSOĊJATI (ARA ANNESS I)
The points of disagreement leading to this referral procedure under Article 29(4) of Directive 2001/ 83/ EC pertained to:
Il- punti tan- nuqqas ta ’ qbil li wasslu għal din il- proċedura ta ’ referenza taħt l- Artikolu 29( 4) tad - Direttiva 2001/ 83/ KE kellhom x’ jaqsmu ma ’:
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
1 - L- indikazzjoni terapewtika li kellha tiġi estiża għal pazjenti li m’ għandhomx kanċer li jsofru minn uġigħ kroniku qawwi 2 - L- għażla ta ’ tabella( i) ta ’ konverżjoni li għandhom jiġu inklużi fis- Sommarju tal- Karatteristiċi tal- Prodotti (SPC) 3 - Jekk it- treddigħ u l- ko- amministrazzjoni ma ’ agonisti parzjali ta ’ l- opijojdi għandhomx ikunu kontra- indikati 4 - L- istudji tal- bijoekwivalenza meħtieġa biex juru l- ekwivalenza mal- prodott ta ’ referenza
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.
Fir- rigward ta ’ l- indikazzjoni terapewtika, id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq ipprovda stqarrija xjentifika, li tiġbor fil- qosor il- pubblikazzjonijiet relatati għat- trattament ta ’ uġigħ mhux tal- kanċer kroniku b’ opijojdi qawwija u b’ mod partikolari fentanyl transdermali.
Besides controversial literature results on the efficacy and safety of fentanyl transdermal in chronic non cancer pain, the CHMP recognised that, in special circumstances, strong opioids could be of help for the treatment of this condition.
Minbarra riżultati kontroversjali tal- letteratura fuq l- effikaċja u s- sigurtà ta ’ fentanyl transdermali f’ uġigħ mhux tal- kanċer kroniku, il- CHMP irrikkonoxxa li, f’ ċirkostanzi speċjali, opijojdi qawwija jistgħu jkunu ta ’ għajnuna fit- trattament ta ’ din il- kondizzjoni.
In this context, the CHMP accepted the indication “ Severe chronic pain which can be adequately managed only with opioid analgesics”.
F’ dan il- kuntest, il- CHMP aċċetta l- indikazzjoni “ Uġigħ kroniku qawwi li jista ’ jkun adegwatament immaniġjat biss b’ analġeżiċi opijojdi ”.
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 .”
Il- CHMP irrakkomanda wkoll iż- żieda ta ’ l- istqarrija segwenti f’ sezzjoni 4. 4 tas- Sommarju tal - Karatteristiċi tal- Prodotti (SPC): “ F’ uġigħ kroniku mhux relatat mal- kanċer, jista ’ jkun preferibbli li tibda t- trattament b’ opijojdi qawwija li jirrilaxxaw ruħhom minnufih (eż. morfina) u li tagħti b’ riċetta roqgħa b’ fentanyl transdermali wara d- determinazzjoni ta ’ l- effikaċja u d- dożaġġ ottimu ta ’ l- opijojd qawwi. ”
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).).
Rigward l- iskemi ta ’ konverżjoni tad- dożi ipprovduti fis- Sommarju tal- Karatteristiċi tal- Prodotti (SPC) minn morfina orali sa fentanyl transdermali, il- CHMP, abbażi tat- tagħrif disponibbli, huwa ta ’ l - opinjoni li ż- żewġ tabelli għandhom jissemmew fis- Sommarju tal- Karatteristiċi tal- Prodotti (SPC) (sezzjoni 4. 2).
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.
L- iskema ta ’ konverżjoni konservattiva (150: 1) kif speċifikata fis- Sommarju tal - Karatteristiċi tal- Prodotti (SPC) preżenti ta ’ Fentanyl ratiopharm hija għal pazjenti li għandhom bżonn rotazzjoni ta ’ l- opijojdi u l- iskema ta ’ konverżjoni 100: 1 (tabella ta ’ Donner) hija għal pazjenti taħt terapija bl- opijojdi stabbli u ittollerata sewwa.
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.
Fir- rigward tat- treddigħ, is- sezzjoni 4. 6 tas- Sommarju tal- Karatteristiċi tal- Prodotti (SPC) ipproponut tgħid: “ Fentanyl jiġi eskretat għal ġol- ħalib tas- sider u jista ’ jikkaġuna sedazzjoni u dipressjoni respiratorja fit- tarbija li tkun qedgħa tiġi imreddgħa.
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.
Dan ifisser li huwa possibbli li tagħti l- prodott lin- nisa li jkunu qed ireddgħu, imma t- treddigħ għandu jitwaqqaf waqt l- użu ta ’ l- irqajja ’ b’ fentanyl u għal 72 siegħa wara.
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.
Minħabba l- importanza ta ’ ġestjoni adegwata ta ’ l- uġigħ għall- omm, il- CHMP jaqbel, b’ mod konformi mal - “ linja gwida tas- sommarju tal- karatteristiċi tal- prodott ”, li t- test ipproponut jibqa ’ f’ sezzjoni 4. 6 u m’ għandux ikun inkluż bħala kontra- indikazzjoni.
In addition, the CHMP recommends including the following information in section 4.4 of the SPC: ….
Barra minn hekk, il- CHMP jirrakkomanda li jiġi inkluż it- tagħrif segwenti f’ sezzjoni 4. 4 fis- Sommarju tal- Karatteristiċi tal- Prodotti (SPC): ….
Lactation As fentanyl is excreted into breast milk, lactation should be discontinued under the treatment with fentanyl (see also section 4.6) ….
Treddigħ Minħabba li fentanyl huwa eskretat fil- ħalib tas- sider, it- treddigħ għandu jitwaqqaf waqt it- trattament b’ fentanyl (ara ukoll sezzjoni 4. 6) ….
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 Fir- rigward ta ’ l- amministrazzjoni fl- istess ħin ma ’ opijojdi oħra, huwa rikonoxxut li r- riskju ta ’ l - ikkumbinar ta ’ fentanyl ma ’ agonist/ antagonist imħallat bħal buprenorphine, nalbuphine u pentazocine, jikkonsisti l- ewwel f’ analġiżja imxekkla, minħabba effetti antagonisti kompettitivi, u t - tieni fil- bidu ta ’ sindromu ta ’ irtirar, li ukoll jirrappreżenta tħassib serju għas- saħħa.
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.
Madankollu, mil- lat kliniku, dan l- aspett jirrappreżenta biss riskju minuri għal pazjenti li qed jirċievu terapija kontra l- uġigħ b’ fentanyl transdermali f’ dożi medji.
There is also no clinical data available which demonstrates withdrawal symptoms in patients treated with transdermal fentanyl after injection of buprenorphine.
Ma hemm l- ebda dejta disponibbli li turi sintomi ta ’ irtirar f’ pazjenti ittrattati b’ fentanyl transdermali wara injezzjoni ta ’ buprenorphine.
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.
Għaldaqstant, is- CHMP jirrakkomanda li, skond il- linja gwida msemmija hawn fuq, dan l- aspett għandu jkun imsemmi f’ sezzjoni 4. 5 tas- Sommarju tal- Karatteristiċi tal- Prodotti (SPC) b’ referenza għalih f’ sezzjoni 4. 4, “ użu fl- istess ħin mhux irrakkomandat ” aktar milli bħala kontra- indikazzjoni.
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 )”.
Fl- aħħarnett, fir- rigward tal- wiri ta ’ bijoekwivalenza, id- diskussjonijiet kienu fuq id- devjazzjonijiet mil- linja gwida “ Nota għal gwida fuq forom ta ’ dożaġġ b’ rilaxx immodifikat orali u transdermali: sezzjoni II: evalwazzjoni farmakokinetika u evalwazzjoni klinika - (CPMP/ EWP/ 280/ 96) ”.
The need to perform a bioequivalence study with the highest strength and a valid study with replicate design was discussed.
Ġiet diskussa l- ħtieġa li jsir studju ta ’ bijoekwivalenza bil- qawwa l- aktar għolja u studju validu b’ disinn irreplikat.
The demonstration of bioequivalence with the lowest strength was questioned, as in the results, a higher initial input is suggested for the reference reservoir patch (comparatively to the test patch) and a lower final input (at the end of the patch application) is evidenced.
Kien hemm dubbji dwar it- turija tal- bijoekwivalenza bl- aktar doża baxxa, minħabba li fir- riżultati, input inizjali aktar għoli huwa issuġġerit għar- roqgħa riżerva ta ’ referenza (meta mqabbla mar- roqgħa tat- test) u huwa evidenzjat input finali aktar baxx (fit- tmiem ta ’ l- applikazzjoni tar- roqgħa).
The peak-to-trough fluctuations of plasma concentrations are higher with the reference product and are not of a high magnitude.
L - oxxilazzjonijiet mill- quċċata għall- aktar punt baxx tal- konċentrazzjonijiet fil- plażma huma aktar għoljin bil- prodott ta ’ referenza u m’ humiex ta ’ daqs kbir.
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.
Il- CHMP jikkunsidra li l- kriterji tal- linja gwida fuq forom ta ’ dożaġġ transdermali - CPMP/ EWP/ 280/ 96 - (jiġifieri proporzjonalità eżatta tal- formulazzjoni u test ta ’ rilaxx aċċettabbli in vitro) intlaqgħu bir- roqgħa ta ’ fentanyl ratiopharm transdermali kif ukoll bil- prodott mediċinali ta ’ referenza.
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.
Barra dan, studju fl- aktar doża għolja (100 µg/ siegħa) jkun possibbli biss fis- swali tal- kura intensiva u taħt trattament konkomitanti b’ antagonisti opijojdi (naltrexone) sabiex jiġu evitati effetti sekondarji li jipperikolaw il- ħajja.
Therefore, due to ethical and safety reasons, it would be questionable to conduct studies with the highest strength when all necessary information could be derived from studies with lower patch strengths.
Għaldaqstant, minħabba raġunijiet etiċi u ta ’ sigurtà, ikun kwestjonabbli li jsiru studji bl- ogħla qawwa meta t- tagħrif neċessarju kollu jista ’ jinkiseb minn irqajja ’ ta ’ qawwiet aktar baxxi.
As a general rule in EU, if such a study would have to be conducted, the 50 µg/ h strength would be recommended.
Bħala regola ġenerali, fl- UE, jekk ikun irid isir studju bħal dan, il- qawwa ta ’ 50 µg/ siegħa għandha tkun irrakkomandata.
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).
L- evalwazzjoni bijostatistika ta ’ l- istudju b’ doża waħda eżistenti b’ disinn replika (iżda ma turix bijoekwivalenza) tista ’ tkun ikkunsidrata tajba biex tevalwa l- varjabbilità ġo l- individwu u biex tiddetermina l- influwenza ta ’ l- eżekuzzjoni bijofarmaċewtika, fir- rigward tal- mekkaniżmi ta ’ rilaxx differenti (riserva kontra matriċi).
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).
Il- CHMP ikkunsidra wkoll illi l- bijoekwivalenza bejn test u prodotti mediċinali ta ’ referenza ġiet ikkaratterizzata suffiċjentement f’ 2 studji (doża waħda u multipla) magħmula b’ roqgħa ta ’ daqs imnaqqas (7. 5 ċm²).
The small differences observed are not deemed to be of clinical importance and suggests that Fentanyl ratiopharm has a somewhat more pronounced prolonged release profile, which is as expected for a matrix patch in comparison with a reservoir patch.
Id- differenzi żgħar osservati m’ humiex meqjusin li huma ta ’ importanza klinika u jissuġġerixxu li Fentanyl ratiopharm x’ aktarx għandu profil ta ’ rilaxx fit- tul aktar fid- deher, li huwa mistenni għal roqgħa matriċi meta mqabbla ma ’ roqgħa riserva
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.
Finalment, minħabba li Fentanyl ratiopharm huwa roqgħa matriċi għal liema, ir- rilaxx huwa proporzjonali għall- erja tal- wiċċ, hija mistennija proporzjonalità fid- doża u studju ta ’ bijoekwivalenza bl- aktar qawwa għolja ma jidhirx neċessarju, lanqas studju ta ’ disinn replika addizzjonali.
8 GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
8 ARGUMENTI GĦAL EMENDI TAS- SOMMARJU( I) TAL- KARATTERISTIĊI TAL - PRODOTT, TIKKETTA U FULJETT TA ’ TAGĦRIF
- the scope of the referral was the potential public health concerns regarding the extension of the
- l- iskop tar- referenza kien it- tħassib potenzjali fir- rigward tas- saħħa pubblika rigward l -
clinical indication
estensjoni ta ’ l- indikazzjoni klinika
- the demonstration of the bioequivalence with the reference product,
- t- turija tal- bijoekwivalenza bil- prodott ta ’ referenza,
- and the harmonisation of the Summary of Product Characteristics, labelling and package leaflet,
- u l- armonizzazzjoni tas- Sommarju tal- Karatteristiċi tal- Prodott, tikketta u fuljett ta ’ tagħrif,
based on the documentation submitted by the Marketing Authorisation Holder and the scientific discussion within the Committee,
fuq il- bażi tad- dokumentazzjoni ppreżentata mid- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u d- diskussjoni xjentifika fi ħdan il- Kumitat,
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).
il- CHMP irrakkomanda l- għoti ta ’ l- Awtorizzazzjoni( jiet) għat- Tqegħid fis- Suq u l- emenda tas - Sommarju tal- Karatteristiċi tal- Prodott, tikketta u fuljett ta ’ tagħrif li huma stabbiliti fl- Anness III għal Fentanyl- ratiopharm u ismijiet assoċjati (ara Anness I).
10 SUMMARY OF PRODUCT CHARACTERISTICS
10 SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT
Fentanyl-ratiopharm 25 µg/ h Matrixpflaster and associated names (see Annex I)
Fentanyl- ratiopharm 25 µg/ h Matrixpflaster u ismijiet assoċjati miegħu (Ara Anness I)
Each patch releases 25 micrograms fentanyl per hour.
Kull garża terħi 25 mikrogramma fentanyl fis- siegħa.
Each patch of 7.5 cm2 contains 4.125 mg fentanyl.
Kull garża ta ’ 7. 5 cm2 fiha 4. 125 mg fentanyl.
Transparent and colourless patch with blue imprint on the backing foil: “ fentanyl 25 µg/ h“.
Garża trasparenti u bla kulur b’ sinjal kaħlani fuq il- fojl warrani: “ fentanyl 25 µg/ h “.
The product is indicated in severe chronic pain which can be adequately managed only with opioid analgesics.
Il- prodott huwa indikat f’ uġigħ qawwi u kroniku li jista ’ jiġi immaniġġjat adegwatament biss bl- użu ta ’ analġesiċi tat- tip opjojdi.
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.
Id- dożaġġ huwa addattat għal kull individwu u ibbażat fuq l- istorja ta ’ kura bl- opjojdi tal- pazjent u jitqies: • Il- possibilita ’ li tiġi żviluppata tolleranza, • Il- kundizzjoni ġenerali fil- preżent, l- istat mediku tal- pazjent, u • Il- grad tas- severita ’ tal- kundizzjoni.
The required fentanyl dosage is adjusted individually and should be assessed regularly after each administration.
Id- doża ta ’ fentanyl hija mfassla individwalment u trid tiġi riveduta ta ’ spiss wara kull amministrazzjoni.
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.
Pazjenti li jirċievu kura bl- opjojdi għall- ewwel darba Garża li terħi 12. 5 mikrogramma/ siegħa hija disponibbli u din għandha tintuża fid- dożaġġ tal- bidu.
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.
Fl- anzjani ta ’ eta ’ kbira ħafna u f’ pazjenti debboli ħafna, mhux irrakkommandat illi tinbeda kura bl - opjojdi bil- Fentanyl- ratiopharm, minħabba is- suxxettibbilita ’ magħrufa li dawn il- pażjenti għandhom għal din it- tip ta ’ kura.
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.
F’ każi bħal dawn, ikun aktar xieraq illi l- kura tinbeda b’ dożi zgħar ta ’ morfina li tintreħa immedjatament u il- Fentanyl- ratiopharm jiġi preskritt biss wara li tiġi stabbilita d- doża ottimali.
Switching from other opioids When changing over from oral or parenteral opioids to fentanyl treatment, the initial dosage should be calculated as follows:
Tibdil minn opjojdi oħrajn F’ każ ta ’ tibdil minn opjojdi orali jew parenterali għal kura bil- fentanyl, id- doża tal- bidu għandha tiġi kkalkulata skond li ġej:
The quantity of analgesics required over the last 24 hours should be determined.
Il- kwantita ’ ta ’ analġesiċi meħtieġa tul l- aħħar 24 siegħa trid tiġi ddeterminata.
The obtained sum should be converted to correspond the oral morphine dosage using Table 1.
It- total miksub għandu jiġi mibdul fid- doża ekwivalenti ta ’ morfina orali permezz ta ’ Tabella 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)
Id- doża ekwivalenti ta ’ fentanyl għandha tiġi determinata skond li ġej: a) permezz ta ’ Tabella 2 għal dawk il- pażjenti li jkollhom bżonn tibdil regolari fil- kura ta ’ l - opjojdi (ir- ratio tal- konverżjoni minn fentanyl orali għal fentanyl transdermali huwa ta ’ 150: 1) b) permezz ta ’ Tabella 3 għal dawk il- pażjenti li qegħdin fuq kura stabbli u tollerata tajjeb bl - opjojdi (ir- ratio tal- konverżjoni minn morfina għal fentanyl transdermali huwa ta ’ 100: 1)
Equianalgesic potency conversion All dosages given in the table are equivalent in analgesic effect to 10 mg parenteral morphine.
Konverżjoni tad- doża li tipprovdi effett analġesiku ekwivalenti:
Equianalgesic doses (mg) Active substance Parenteral (im) Oral Morphine Hydromorphone Oxycodone Methadone Levorphanol Oxymorphine Diamorphine Pethidine Codeine Buprenorphine Ketobemidone
Id- dożi li jidhru f’ din it- tabella għandhom l- effett analġesiku ekwivalenti ta’ 10mg morfina parenterali Doża li tipprovdi effett analġesiku ekwivalenti (mg) Sustanza Attiva Parenterali (im) Morfina 10 Hydromorphone 1. 5 Oxycodone 10- 15 Methadone 10 Levorphanol 2 Oxymorphine 1 Diamorphine 5 Pethidine 75 Codeine - Buprenorphine 0. 4 Ketobemidone 10
30-40 7.5 20-30 20 4 10 (rectal) 60 - 200 0.8 (sublingual) 20-30
Orali 30- 40 7. 5 20- 30 20 4 10 (rettali) 60 - 200 0. 8 (taħt l- ilsien) 20- 30
Recommended initial dose of transdermal fentanyl based on daily oral morphine dose (for patients who have a need for opioid rotation)
Doża inizjali rakkomandata ta’ fentanyl transdermali bbażata fuq doża ta ’ ġurnata ta ’ morfina orali (għal dawk il- pażjenti li jkollhom bżonn ta ’ tibdil regolari fil- kura bl- opjojdi)
dose (mg/ 24 h) < 44
Doża ta ’ morfina orali
Transdermal fentanyl release (micrograms/ h) 12.5
Irħir ta ’ fentanyl transdermali
315-404 405-494 495-584 585-674 675-764 765-854 855-944
(milligramma/ 24 siegħa) < 44 45- 134 135- 224 225- 314 315- 404 405- 494 495- 584 585- 674 675- 764 765- 854 855- 944 945- 1034 1035- 1124
100 125 150 175 200 225 250
(mikrogramma/ siegħa) 12. 5 25 50 75 100 125 150 175 200 225 250 275 300
Table 3:
Tabella 3::
Recommended initial dose of transdermal fentanyl based on daily oral morphine dose (for patients on stable and well tolerated opioid therapy)
Doża inizjali rakkomandata ta’ fentanyl transdermali bbażata fuq doża ta ’ ġurnata ta ’ morfina orali (għal dawk il- pażjenti li huma stabbli u jitolleraw tajjeb il- kura tagħhom bl- opjojdi)
Oral morphine dose (mg/ 24 h) < 60
Doża ta ’ morfina orali
60-89 90-149 150-209 210-269 270-329 330-389 390-449 450-509 510-569 570-629 630-689 690-749
(milligramma/ 24 siegħa) < 60 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
(mikrogramma/ siegħa) 12. 5 25 50 75 100 125 150 175 200 225 250 275 300
13 By combining several transdermal patches, a fentanyl release rate of over 100 micrograms/ h can be achieved.
13 Bit- taħlit ta ’ bosta biċċiet ta’ garża transdermali, tista ’ tinkiseb rata ta ’ irħir ta ’ fentanyl il fuq minn 100 mikrogramma fis- siegħa.
The initial evaluation of the maximum analgesic effect of Fentanyl-ratiopharm should not be made before the patch has been worn for 24 hours.
L- evalwazzjoni inizjali ta ’ l- effett analġesiku massimu ta’ Fentanyl- ratiopharm m’ għandiex issir qabel il- garża tintlibes għal mill- inqas 24 siegħa.
This is due to the gradual increase in serum fentanyl concentrations during the first 24 hours after application of the patch.
Dan minħabba iż- żieda gradwali tal- konċentrazzjoni ta ’ fentanyl fis- serum matul l- ewwel 24 siegħa wara li l- garża tkun applikata.
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.
Fl- ewwel 12- il siegħa wara bidla għall- Fentanyl- ratiopharm, il- pazjent għandu jibqa ’ jirċievi l- analġesiku ta ’ qabel u bl- istess doża; għat- 12 il siegħa ta ’ wara, dan l- analġesiku għandu jiba ’ jinagħata skond il- bżonn.
Dose titration and maintenance therapy The patch should be replaced every 72 hours.
Titrazzjoni tad- doża u d- dożaġġ ta ’ manteniment Il- garża trid tinbidel kull 72 siegħa.
The dose should be titrated individually until analgesic efficacy is attained.
Id- doża trid tiġi mibdula skond l- individwu sakemm l- effiċjenza analġesika tiġi stabbilita.
In patients who experience a marked decrease in the period 48-72 hours after application, replacement of fentanyl after 48 hours may be necessary.
F’ pazjenti li jħossu tnaqqis sostanzjali tal- effett fil- perijodu bejn 48- 72 siegħa wara l- applikazzjoni, tista ’ tinbidel il- garża ta ’ fentanyl wara 48 siegħa.
Patches with a release rate of 12.5 micrograms/ hour are available and are appropriate for dose titration in the lower dosage area.
Garża b’ rata ta ’ irħir ta ’ 12. 5 mikrogramma/ siegħa hija disponibbli u hija adattata għat- titrazzjoni tad - doża meta l- livell tad- dożaġġ meħtieġ ikun baxx.
If analgesia is insufficient at the end of the initial application period, the dose may be increased after 3 days, until the desired effect is obtained for each patient.
Jekk it- tnaqqis fl- uġigħ sa l- aħħar tal- perjodu inizjali ma jkunx biżżejjed, id- doża tista ’ tiżdied wara 3 ijiem, sakemm l- effett mixtieq għal kull pazjent jintlaħaq.
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.
Tibdiliet oħrajn fid- doża normalment għandhom isiru b’ żidiet ta ’ 25 mikrogramma/ siegħa, iżda għandu jitqies ukoll il- bżonn ta ’ analġesiċi supplementari u l- istat ta ’ uġigħ tal- pazjent.
Patients may require periodic supplemental doses of a short-acting analgesic for breakthrough pain.
Pazjenti jistgħu jkollhom bżonn ta ’ dożi supplementari ta’ analġesiċi kull tant żmien li jaħdmu malajr biex jilqgħu kontra ħruġ ta ’ l- uġigħ.
Additional or alternative methods of analgesia or alternative administration of opioids should be considered when the Fentanyl-ratiopharm dose exceeds 300 micrograms/ hour.
Metodi addizzjonali jew alternattivi ta ’ kura kontra l- uġigħ jew anke amministrazzjoni ta ’ opjojdi oħrajn għandhom jiġu kkunsidrati meta d- doża ta ’ Fentanyl ratiopharm taqbeż 300 mikrogramma/ siegħa.
Withdrawal symptoms have been reported when changing from long-term treatment with morphine to transdermal fentanyl despite adequate analgesic efficacy.
Sintomi assoċjati mal- waqfien tal- kura ġew irrapportati meta kura fit- tul b’ morfina nbidlet f’ wahda transdermali b’ fentanyl, minkejja kura analġesika effikaċi u adeguata.
In case of withdrawal symptoms it is recommended to treat those with short-acting morphine in low doses.
Huwa rrakkomandat illi pazjenti li juru sintomi assoċjati mal- waqfien tal- kura jingħataw dożi żgħar ta’ morfina b’ effett qasir.
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.
Tibdil jew waqfien tat- terapija Jekk l- użu tal- garża jrid jiġi mwaqqaf, kull bidla għal opjojdi oħrajn għandha tkun gradwali, tibda b’ doza baxxa u tiżdied bil- mod.
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%.
Dan għaliex il- livelli ta ’ fentanyl jinżlu gradwalment wara li titneħħa il- garża; ikun hemm bżonn mill- inqas 17- il siegħa sabiex il- konċentrazzjoni ta ’ fentanyl fis- serum jaqa 'b’ 50%.
As a general rule, the discontinuation of opioid analgesia should be gradual, in order to prevent withdrawal symptoms (nausea, vomiting, diarrhoea, anxiety and muscular tremor).
Bħala regola ġenerali, it- twaqqif tal- kura analġesika b’ opjojdi jrid ikun gradwali, sabiex jiġu evitati sintomi assoċjati mal- waqfien tal- kura (tqalliegħ, rimettar, dijarea, ansjeta’ u tregħid muskolari).
Tables 2 and 3 should not be used to switch from transdermal fentanyl to a morphine treatment.
Tabella 2 u tabella 3 m’ għandhomx jintużaw meta tinbidel il- kura minn garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda bil- fentanyl għal kura bil- morfina.
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).
Metodu ta ’ l- mministrazzjoni Hekk kif titneħħa mill- pakkett u r- release liner, il- garża għandha tiġi applikata fuq parti tal- ġilda mingħajr pil lejn in- naħa ta ’ fuq tal- ġisem (sider, dahar, dirgħajn).
To remove hair, scissors should be used instead of razors.
Bix jitneħħa l- pil għandu jintuża mqass u mhux xafra.
Prior to application, the skin should be carefully washed with clean water (no cleaning agents) and thoroughly dried.
Qabel l- applikazzjoni, il- ġilda trid titnaddaf b’ attenzjoni bl- użu ta ’ ilma safi (l- ebda aġenti ta ’ tindif) u titnixxef sewwa.
The transdermal patch is then applied using slight pressure with the palm of the hand for approximately 30 seconds.
Eżatt wara, il- garża transdermali tiġi applikata permezz ta ’ pressjoni ħafifa bil- pala tal- id għal madwar 30 sekonda.
The skin area to which the patch is applied should be free of microlesions (e. g. due to irradiation or shaving) and skin irritation.
Il- parti tal- ġilda fejn ser tiġi applikata il- garża m’ għandhiex ikollha qsim żgħar (eż. minħabba radjazzjoni jew tqaxxir) u l- ġilda m’ għandhiex tkun irritata.
As the transdermal patch is protected by an outer waterproof backing film, it can also be worn while showering.
Peress li l- garża transdermali hija protetta b’ film estern fuq in- naħa ta ’ wara li jiflaħ għall- ilma, tista ’ tintlibes wkoll waqt id- doċċa.
Occasionally, additional adhesion of the patch may be required.
Xi drabi, il- garża jkollha titwaħħal aħjar b’ xi ħaġa oħra..
If progressive dose increases are made, the active surface area required may reach a point where no further increase is possible.
Jekk isiru żidiet progressivi fid- doża, l- erja tas- superfiċje attiva meħtieġa tista ’ tilħaq il- punt illi aktar żidiet ma jkunux fiżikament possibli.
Duration of administration The patch should be changed after 72 hours.
Tul ta ’ l- amministrazzjoni Il- garża għandha tinbidel kull 72 siegħa.
If an earlier change becomes necessary in individual cases, no change should be made before 48 hours have elapsed, otherwise a rise in mean fentanyl concentrations may occur.
Jekk għal xi raġuni jkun jinħtieg li tinbidel qabel il- waqt, l - ebda tibdil m’ għandu jsir qabel ma jkunu għaddew 48 siegħa, inkella jista ’ jkun hemm żieda fil- koncentrazzjoni medja ta’ fentanyl.
A new skin area must be selected for each application.
Irid jintagħżel post ġdid fuq il- ġilda għal kull applikazzjoni,.
The analgesic effect may persist for some time after removal of the transdermal patch.
14 Mill- inqas 7 ijiem iridu jkunu għaddew qabel ma titwaħħal garża fuq l- istess parti tal- ġilda. L- effett analġesiku jista ’ jdum għal xi żmien wara li tkun tneħħiet il- garża transdermali.
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.
Jekk jibqgħu xi biċċiet tal- garża fuq il- ġilda wara li din titneħħa, dawn jistgħu jitneħħew bl- użu ta ’ ammonti kbar ta ’ ilma u sapun.
No alcohol or other solvents must be used for cleaning, as these may penetrate the skin due to the effect of the patch.
M’ għandhux jintuża l- alkoħol jew solventi oħra biex titnaddaf il- ġilda, għaliex dawn jistgħu jippenetraw fil- ġilda minħabba l- effett tal- garża.
Paediatric population The experience in children under 12 years of age is limited.
Tfal u addoloxxenti L- esperjenza dwar l- użu fit- tfal ta ’ taħt it- 12- il sena hija limitata.
Fentanyl-ratiopharm should not be used in this population.
Fentanyl- ratiopharm m’ għandiex tintuża f’ din il- popolozzjoni ta ’ pazjenti
Use in elderly patients Elderly should be observed carefully and the dose reduced if necessary (see sections 4.4 and 5.2).
Anzjani L- anzjani iridu jkunu osservati mill- qrib u d- doża għandha tiġi mnaqqsa jekk ikun hemm bżonn (ara sezzjoni 4. 4 u 5. 2).
Hepatic and renal impairment Patients with hepatic or renal impairment should be observed carefully and the dose reduced if necessary (see section 4.4).
Indeboliment epatiku u renali Pazjenti b’ indeboliment epatiku jew renali iridu jkunu osservati mill- qrib u d- doża għandha tiġi mnaqqsa jekk ikun hemm bżonn (ara sezzjoni 4. 4).
- Hypersensitivity to the active substance or to any of the excipients.
- Ipersensittività għas- sustanza attiva jew għal xi sustanzi mhux attivi.