qanastek/EMEA-V3 huggingface dataset:
- Acute or postoperative pain, since dosage titration is not possible during short-term use.
- Uġigħ akut jew ta ’ wara operazzjoni, għax titrazzjoni tad- doża mhix possibbli waqt kura qasira.
- Severe impairment of the central nervous system.
- Indeboliment sever tas- sistema nervuża ċentrali
The product should be used only as part of an integrated treatment of pain in cases where the patient is adequately assessed medically, socially and psychologically.
Il- prodott għandu jintuża biss bħala parti minn kura integrali tal- uġigħ f’ każi fejn il- pazjent jista jiġi ikkontrollat b’ mod mediku, soċjalment u psikoloġikalment kif inhu xieraq.
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.
Kura bil- Fentanyl – ratiopharm għandha tinbeda biss minn tabib espert u li hu mgħarref sew fil- farmakokinetika ta ’ garża transdermali ta ’ fentanyl u l- periklu ta ’ ipoventilazzjoni severa.
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).
Wara reazzjoni avversa u serja, il- pazjent irid jibqa ’ taħt osservazzjoni għal 24 siegħa wara li titneħħa il- garża minħabba il- half life ta ’ fentanyl (ara sezzjoni 5. 2).
The transdermal patch should not be cut, since no information is available on the quality, efficacy and safety of such divided patches.
F’ kaz ta ’ uġiegħ kroniku li mhux ġej minn kanċer, il- kura tista ’ tinbeda b’ opjojd qawwi b’ reħa immedjata (eż. morfina), u tiġi preskritta Fentanyl- ratiopharm wara li tiġi stabbilita l- effikaċja u l- aħjar dożaġġ ta ’ l- opjojd qawwi Il- garża transdermali m’ għandiex tinqata ’, għax m’ hemmx informazzjoni disponibbli fuq il- kwalita ’, l - effikaċja u s- sigurta ’ ta ’ garża hekk masqsuma.
If higher dosages than 500 mg morphine-equivalent are needed, a reassessment of opioid-therapy is recommended.
Jekk ikun hemm bżonn ta ’ dożi ‘ l fuq mill- ekwivalenti ta ’ 500 mg morfina, huwa rrakkomandat illi t- terapija bl- opjojdi tiġi evalwata mill ġdid.
The most common adverse reactions following administration at usual doses are drowsiness, confusion, nausea, vomiting and constipation.
Wara l- amministrazzjoni b’ dozi rakkomandati, r- reazzjonijiet avversi l- aktar komuni huma ħedla, konfużjoni, tqalligħ, rimettar u stitikezza.
The first of these are transient and their cause should be investigated if symptoms persist.
Dawn ta ’ l- ewwel huma ta ’ natura ħafifa u għal żmien qasir u l- kawża tagħhom trid tiġi investigata jekk is- sintomi jippersistu.
Constipation, on the other hand, does not stop if treatment continues.
Mill- banda l- oħra, stitikezza ma ’ tieqafx sakemm titkompla il- kura.
All of these effects can be expected and should, therefore, be anticipated in order to optimise treatment, especially constipation.
Dawn l- effetti kollha huma mistennija u, għaldaqstant, għandha tittieħed azzjoni minn qabel, speċjalment fir- rigward tas- stitikezza, sabiex il- kura tkun l- aħjar possibbli.
Corrective treatment may often be required (see section 4.8).
Ta ’ spiss, jitsta ’ jagħti l- każ li jkun hemm bżonn ta ’ kura korrettiva (ara sezzjoni 4. 8).
The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended (see also section 4.5).
L- użu konkomittanti ta ’ buprenorphine, nalbuphine jew pentazocine mhux irrakkomandat (ara sezzjoni 4. 5)
Respiratory depression
Ħruġ ta ’ uġigħ mhux mistenni
15 As with all potent opioids some patients may experience respiratory depression with Fentanyl- ratiopharm, and patients must be observed for this effect.
15 Minkejja kura b’ garza ta ’ fentanyl, stħarriġ wera li kważi l- pazjenti kollha jkollhom bżonn ta ’ mediċini qawwija u li jaħdmu fil- pront sabiex jilqgħu immedjatament kontra l- ħruġ ta ’ uġigħ mhux mistenni.
Respiratory depression may persist beyond the removal of the patch.
Id- dipressjoni respiratorja tista ’ tippersisti wkoll wara li titneħħa l- garża.
The incidence of respiratory depression increases as the fentanyl dose is increased.
L- inċidenza tad - dipressjoni respiratorja tiżdied hekk kif tiżdied id- doża ta ’ fentanyl.
CNS active substances may worsen the respiratory depression (see section 4.5).
Sustanżi attivi li jaffettwaw is - CNS jistgħu jaggravaw d- dipressjoni respiratorja (ara sezzjoni 4. 5).
In patients with existing respiratory depression, fentanyl should only be used with caution and at a lower dose.
F’ pazjenti fejn id- dipressjoni repiratorju diġa ’ hija preżenti, il- fentanyl għandu jintuża b’ kawtela kbira u f’ dożi baxxi.
Chronic pulmonary disease In patients with chronic obstructive or other pulmonary diseases fentanyl may have more severe adverse reactions, in such patients opioids may decrease respiratory drive and increase airway resistance.
F’ dawn il- pazjenti, l- opjojdi jistgħu jbaxxu ir- ritmu respiratorju u jżidu r - resistenza għall- arja fil- passaġġ respiratorju.
Drug dependence Tolerance and physical and psychological dependence may develop upon repeated administration of opioids, but is rare in treatment of cancer related pain.
Dipendenza fuq id- droga Tolleranza u dipendenza fisika u psikoloġika tista ’ tiżviluppa bl- amministrazzjoni ripetuta tal- opjojdi, iżda huma rari fil- kura ta ’ l- uġigħ relatat mal- kanċer.
Increased intracranial pressure Fentanyl-ratiopharm should be used with caution in patients who may be particularly susceptible to the intracranial effects of CO2 retention such as those with evidence of increased intracranial pressure, impaired consciousness or coma.
Żieda tal- pressjoni ġol- kranju Fentanyl- ratiopharm għandu jintuża bil- prudenza f’ pazjenti li jistgħu jkunu iktar suxxettibli għall - effetti ġewwa l- kranju ġejjin minħabba retenzjoni ta’ CO2, bħal ma huma dawk b’ evidenza ta ’ żieda tal- pressjoni ġol- kranju, diffikulta ’ li jibqgħu konxji, jew koma.
Cardiac disease Opioids may cause hypotension, especially in patients with hypovolemia.
Mard tal- qalb L- opjojdi jistgħu jikkawżaw pressjoni baxxa, speċjalment f’ pazjenti li jbatu minn ipovolimja.
Caution should therefore be taken in treatment of patients with hypotension and/ or patients with hypovolemia.
Pazjenti li jbatu minn pressjoni baxxa u/ jew pazjenti li jbatu minn ipovolimja jridu jkunu kkurati b’ attenzjoni kbira.
Fentanyl may produce bradycardia.
Fentanyl jista ’ jipproduċi bradikardja.
Fentanyl-ratiopharm should be administered with caution to patients with bradyarrhythmias.
Fentanyl- ratiopharm irid jiġi amministrat bi prudenza f’ pazjenti li jbatu minn bradiarritmija.
Impaired liver function Fentanyl is metabolised to inactive metabolites in the liver, so patients with hepatic disease might have a delayed elimination.
Indeboliment tal- fwied Fentanyl jiġi metabolizzat fil- fwied f’ mataboliti inattivi; għalhekk l- eliminazzjoni tista ’ tieħu iktar fit - tul f’ pazjenti li jbatu minn mard tal- fwied.
Patients with hepatic impairment should be observed carefully and the dose reduced if necessary.
Pazjenti li jbatu minn indeboliment tal- fwied għandhom jiġu osservati b’ attenzjoni u id- doża għandha tiġi mnaqqsa fejn ikun hemm bżonn.
Renal impairment Less than 10% of fentanyl is excreted unchanged by the kidneys, and unlike morphine, there are no known active metabolites eliminated by the kidneys.
Indeboliment renali Inqas minn 10% ta ’ fentanyl jiġi eliminat bħala prodott mhux mibdul mill- kliewi u, kuntrarjament għal morfina, m’ hemm l- ebda metaboliti attivi magħrufa li jiġu eliminati mill- kliewi.
Data obtained with intravenous fentanyl in patients with renal failure suggest that the volume of distribution of fentanyl may be changed by dialysis.
Tagħrif miġbur wara l- amministrazzjoni tal- fentanyl ġol- vina f’ pazjenti b’ insuffiċjenza renali jindika li l- volum ta ’ distribuzzjoni tal- fentanyl jista ’ jinbidel bid- dijaliżi.
This may affect serum concentrations.
Dan jista ’ jaffetwa l- konċentrazzjonijiet fis - serum.
If patients with renal impairment receive transdermal fentanyl they should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary.
Jekk pazjenti b’ indeboliment renali jirċievu fentanyl transdermali, dawn għandhom jiġu osservati bir- reqqa għal xi ħjiel ta ’ tossiċita ’ tal- fentanyl u d- doża għandha tiġi mnaqqsa jekk ikun hemm il- bżonn.
Patients with fever/ external heat Significant increases in body temperature can potentially increase fentanyl absorption rate.
Pazjenti b’ deni/ sħana esterna Żieda sostanzjali fit- temperatura tal- ġisem tista ’ tirriżulta f’ żieda fir- rata ta ’ assorbiment ta ’ fentanyl.
Therefore patients who develop fever should be monitored for opioid adverse reactions.
Għalhekk, pazjenti li jkollhom id- deni jridu jkunu monitorjati għal xi reazzjonijiet avversi tal- opjojdi.
The patch application site should not be exposed to heat from external heat sources, e. g. sauna.
Il- post fejn tiġi applikata il- garża m’ għandux jiġi espost għas- sħana ġejja minn sorsi esterni eż. Sawna.
Elderly patients Data from intravenous studies with fentanyl suggest that the elderly patients may have reduced clearance and a prolonged half-life.
Pazjenti anzjani Tagħrif minn studji li saru bl- amministrazzjoni ta ’ fentanyl ġol- vina jindika li f’ pazjenti anzjani jista ’ jkun hemm rata ta ’ eliminazzjoni mnaqqsa u half- life itwal.
Moreover elderly patients may be more sensitive to the active substance than younger patients.
Barra minn hekk, l- anzjani jistgħu ikunu aktar sensittivi għas- sustanza attiva minn pazjenti iżgħar minnhom.
However, studies of fentanyl transdermal patch in elderly patients demonstrated fentanyl pharmacokinetics which did not differ significantly from young patients although serum concentrations tended to be higher.
16 bl- użu tal- Fentanyl transdermal patch f’ pazjenti anzjani, irriżulta li ma kienx hemm differenza sinjifikanti fil- parametri farmakokinetiċi ħdejn pazjenti żgħar, għalkemm il- konċentrazzjonijiet fis - serum kellhom tendenza li jkunu ogħla.
Elderly or cachectic patients should be observed carefully and the dose reduced if necessary.
Pazjenti anzjani jew kakesiċi għandhom jiġu osservati b’ attenzjoni u id- doża għandha tiġi mnaqqsa jekk ikun hemm il- bżonn.
Paediatric patients 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.
Pazjenti pedjatriċi Minħabba l- użu limitat fit- tfal taħt it- 12- il sena, Fentanyl- ratiopharm għandu jintuża f’ din il - kategorija ta ’ pazjenti biss wara li jiġi stabbilit sewwa jekk il- benefiċċju potenzjali jiġġustifikax ir - riskju potenzjali assoċjat mal- użu.
16 Lactation As fentanyl is excreted into breast milk, lactation should be discontinued under treatment with Fentanyl-ratiopharm (see also section 4.6).
Peress illi fentanyl jiġi eliminat fil- ħalib tal- omm, it- treddiegħ għandu jitwaqqaf waqt kura bil- Fentany- ratiopharm (ara sezzjoni 4. 6)
Patients with myasthenia gravis Non-epileptic (myo)clonic reactions can occur.
Pazjenti b’ majestenja gravis Jista ’ jkun hemm rejazzjonijiet mhux epilettiċi (mijo) kloniċi.
Caution should be exercised when treating patients with myasthenia gravis.
Pazjenti b’ majestenja gravis għandhom jiġu kkurati bil- prudenza.
Interactions Combination with barbituric acid derivatives, buprenorphine, nalbuphine and pentazocine should in general be avoided (see section 4.5).
Interazzjonijiet Bħala regola, l- użu kkombinat ma derivattivi ta ’ barbituric acid, buprenorphine, nalbuphine u pentazocine għandu jiġi evitat (ara sezzjoni 4. 5)
The concomitant use of barbituric acid derivatives should be avoided, since the respiratory depressing effect of fentanyl may be increased.
L- użu fl- istess ħin ta ’ derivattivi ta ’ barbituric acid għandu jiġi evitat, peress li l- effett ta ’ dipressjoni repiratorja kawżat mill- fentanyl jista ’ jiżdied.
The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended.
L- użu konkomittanti ta ’ buprenorphine, nalbuphine jew pentazocine mhux rakommandat.
They have high affinity to opioid receptors with relatively low intrinsic activity and therefore partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependant patients (see also section 4.4).
Għaldaqstant jopponu parzjalment l- effett analġesiku ta ’ fentanyl u jistgħu ikunu kawża ta ’ sintomi assoċjati mal- waqfien tal- kura f’ pazjenti dipendenti fuq l- opjojdi (ara sezzjoni 4. 4)
The concomitant use of other CNS depressants may produce additive depressant effects and hypoventilation, hypotension as well as profound sedation or coma may occur.
L- użu konkomittanti ta ’ dipressanti oħrajn tas- CNS jista ’ jikkawża żiieda fl- effetti dipressanti, u jista ’ jkun hemm ipoventilazzjoni, pressjoni baxxa kif ukoll sedazzjoni qawwija jew koma.
The CNS depressants mentioned above include:
Id- dipressanti tas- CNS imsemmija jinkludu:
- opioids
- opjojdi
- anxiolytics and tranquilizers
- ansjolitiċi u trankwillanti
- hypnotics
- ipnotiċi
- general anaesthetics
- anestetiċi generali
- phenothiazines
- phenothiazines
- skeletal muscle relaxants
- Rilassanti tal- muskoli skeletali
- sedating antihistamines
- antiistaminiċi b’ effetti sedattivi
- alcoholic beverages
- xorb alkoħoliku
Therefore, the use of any of the above mentioned concomitant medicinal products and active substances require observation of the patient.
Għalhekk, l- użu ta ’ xi wieħed mill- kumbinazzjonijiet bejn medicini u sustanzi attivi hawn fuq imsemmija jirrikjedi sorveljanza stretta tal- pazjent.
MAO-inhibitors have been reported to increase the effect of narcotic analgesics, especially in patients with cardiac failure.
Inibituri tal- MAO gew irrapurtati li jżidu l- effett tal- analġesiċi narkotiċi, speċjalment f’ pazjenti li jbatu minn insuffiċjenza tal- qalb.
Therefore, fentanyl should not be used within 14 days after discontinuation of treatment with MAO-inhibitors.
Għalhekk, fentanyl m’ għandux jintuża qabel ma ’ jgħaddu 14- il ġurnata mill- waqfien ta ’ kura bl- inibituri tal- MAO.
Fentanyl, a high clearance active substance, is rapidly and extensively metabolised mainly by CYP3A4.
Fentanyl, sustanza li għandha rata ta ’ tneħħija għolja, tiġi metabolizzata malajr u b’ mod estensiv, l- aktar minn CYP3A4.
Itraconazole (a potent CYP3A4 inhibitor) at 200 mg/ day given orally for four days had no significant effect on the pharmacokinetics of intravenous fentanyl.
Madankollu,
Increased plasma concentrations were, however, observed in individual subjects.
17 f’ xi individwi, ġew osservati żiediet tal- konċentrazzjoni fil- plażma.
Oral administration of ritonavir (one of the most potent CYP3A4 inhibitors) reduced the clearance of intravenous fentanyl by two thirds and doubled the half- life.
L- amministrazzjoni orali ta ’ ritonavir (wieħed mill- inibituri l- iktar qawwi ta ’ CYP3A4) tbaxxi b’ żewġ terzi r- rata tat- tneħħija ta ’ fentanyl mogħti minn ġol- vina, u tirdoppja l- half- life.
Concomitant use of potent CYP3A4-inhibitors (e. g. ritonavir) with transdermally administered fentanyl may result in increased plasma concentrations of fentanyl.
L- użu fl- istess ħin ta ’ inibituri qawwijin ta ’ CYP3A4 (ez. ritonavir) ma użu transdermali ta ’ fentanyl jista ’ jirriżulta f’ żieda fil - konċentrazzjoni fil - plażma ta ’ fentanyl.
This may increase or prolong both the therapeutic effects and the adverse reactions, which may cause severe respiratory depression.
Dan jista ’ jzid jew itawwal, kemm l- effetti terapewtiċi, kif ukoll l- effetti avversari, b’ rizultat ta ’ dipressjoni respiratorja qawwija.
In such cases increased care and observation of the patient should be undertaken.
F’ każi bħal dawn, hemm bżonn li l- pazjent jiġi kkurat u osservat b’ aktar attenzjoni.
Combined use of ritonavir or other potent CYP3A4-inhibitors with transdermal fentanyl is not recommended, unless the patient is carefully observed.
L- użu fl- istess ħin ta ’ ritonavir, jew inibituri qawwijin ta ’ CYP3A4 oħrajn, ma ’ l- użu transdermali ta ’ fentanyl m’ huwiex irrakkomandat sakemm il- pazjent ma jiġix osservat bir- reqqa.
17 The safety of fentanyl in pregnancy has not been established.
Is- sigurta ’ fl- użu ta ’ fentanyl fit- tqala għada ma gietx stabbilita.
Studies in animals have shown reproductive toxicity (see section 5.3).
Studji fuq annimali urew tossiċita ’ fis- sistema riproduttiva (ara sezzjoni 5. 3).
The potential risk for humans is unknown.
Ir- riskju potenzjali fuq il- bniedem għadu mhux magħruf.
Fentanyl should only be used during pregnancy when clearly necessary.
Fentanyl m’ għandux jintuża waqt it- tqala ħlief meta jkun hemm il- bżonn ċar.
Long-term treatment during pregnancy may cause withdrawal symptoms in the infant.
Kura fit- tul waqt it- tqala, tista ’ tikkawża sintomi assoċjati mal- waqfien tal- kura fit- tarbija.
It is advised not to use fentanyl during labour and delivery (including caesarean section) since fentanyl passes the placenta and may cause respiratory depression in the new born infant.
L- użu ta ’ fentanyl waqt it- tqala u il- ħlas (anke ħlas ċesarju) m’ huwiex irrakkommandat għax il- fentanyl jgħaddi mill- plaċenta u jista ’ jikkawza dipressjoni respiratorja fit- tarbija tat- twelid.
Fentanyl is excreted into breast milk and may cause sedation and respiratory depression in the breast- fed infant.
Fentanyl joħroġ fil- ħalib tas- sider u għaldaqstant jista ’ jkollu effetti sedattivi u jikkawza dipressjoni respiratorja fit- trabi li qed jerdgħu.
Lactation should therefore be discontinued during treatment and for at least 72 hours after the removal of Fentanyl-ratiopharm (see also section 4.4)
Għalhekk, it- treddiegħ irid jitwaqqaf waqt il- kura u sa mill- inqas 72 siegħa wara li titneħħa il- Fentanyl- ratiopharm (ara sezzjoni 4. 4)
Fentanyl-ratiopharm has major influence on the ability to drive and use machines.
Fentanyl- ratiopharm għandu effett qawwi ħafna fuq il- ħila ta 'sewqan u l- użu ta ’ magni.
This has to be expected especially at the beginning of treatment, at any change of dosage as well as in connection with alcohol or tranquilizers.
Dan għandu jkun mistenni speċjalment fil- bidu tal- kura, meta tinbidel id- doża, kif ukoll meta jintuża flimkien mal - alkoħol jew aġenti sedattivi.
Patients stabilized on a specific dosage will not necessarily be restricted.
Dawn ir- restrizzjonijiet mhux bil- fors japplikaw għal dawk il- pazjenti li jinsabu fl- istat fiss fuq dożaġġ speċifiku.
Therefore, patients should consult their physician as to whether driving or use of machines is permitted.
Għalhekk, pazjenti għandhom ifittxu l- parir tat- tabib biex jaraw jekk jistgħux isuqu u jħaddmu magni.
Very common (≥ 1/ 10), Common (≥ 1/ 100, < 1/ 10), Uncommon (≥ 1/ 1000, < 1/ 100), Rare (≥ 1/ 10,000, < 1/ 1000), Very rare (< 1/ 10,000)
Reazzjonijiet avversi huma kklassifikati taħt it- titlu tal- frekwenza, l- aktar frekwenti l- ewwel, bil- konvenzjoni li ġejja: komuni ħafna (≥ 10%), komuni (≥ 1% u < 10%), mhux komuni (≥ 0. 1% u < 1%), rari (≥ 0. 01% u < 0. 1%), rari ħafna (≤ 0. 01%).
The most serious undesirable effect of fentanyl is respiratory depression.
L- effett mhux mixtieq, l- iktar serju, kkawżat mill- fentanyl huwa d- dipressjoni respiratorja.
Cardiac disorders Uncommon: tachycardia, bradycardia.
Disturbi fil- qalb Mhux komuni: takikardija, bradikardija.
Rare: arrhythmia.
Rari: arritmija.
Nervous system disorders Very common: headache, dizziness.
Disturbi fis- sistema nervuża Komuni ħafna: uġigħ ta ’ ras, sturdament.
Uncommon: tremor, paraesthesia, speech disorder.
Mhux komuni: tregħid, parasteżija, anormalitajiet fil- kliem u fil- lingwa.
ataxia, seizures (including clonic and grand mal seizures).
ataxia, aċċessjonijiet, (kemm tat- tip kloniku kif ukoll grand mal).
Very rare:
Disturbi fl- għajnejn Rari ħafna:
Respiratory, thoracic and mediastinal disorders Uncommon: dyspnoea, hypoventilation.
Disturbi respiratorji, toraċiċi, u medjastinali Mhux komuni: qtugħ ta ’ nifs, rata baxxa tat- teħid tan- nifs.
respiratory depression, apnoea.
dipressjoni respiratorja, apneja.
Gastrointestinal disorders Very common: nausea, vomiting, constipation.
Disturbi gastro- intestinali Komuni ħafna: tqalliegħ, rimettar, stitikezza.
Common:
18 Komuni:
Uncommon: diarrhoea.
Mhux komuni:
Rare: hiccup.
Rari:
painful flatulence, ileus.
gżerostomja, dispepsja. dijarea sulluzzu. gass fl- istonku bl- uġigħ, sadd fl- imsaren (ileju).
Renal and urinary disorders Uncommon: urinary retention.
Disturbi fil- kliewi u fis- sistema urinarja Mhux komuni: żamma ta ’ l- awrina.
cystalgia, oliguria.
uġigħ fil- bużżieqa ta ’ l- awrina, oligurja.
Skin and subcutaneous tissue disorders Very common: sweating, pruritus.
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Komuni ħafna: żieda fl- għaraq, ħakk.
18 Common:
Komuni:
skin reactions on the application site.
reazzjonijiet tal- ġilda fil- post fejn titwaħħal il- garża.
Rash, erythema and pruritus will usually disappear within one day after the patch has been removed.
Mhux komuni: exantema, eritema Ir- raxx, l- eritema u l- ħakk is- soltu jisparixxu f’ inqas minn ġurnata wara li titneħħa l- garża.
Vascular disorders Uncommon: hypertension, hypotension.
Disturbi vaskulari Mhux komuni: pressjoni għolja, pressjoni baxxa.
Rare: vasodilatation.
Rari: vasodilatazzjoni.
General disorders and administration site conditions Rare: oedema, cold feeling.
Disturbi ġenerali u kundizzjonijiet fil- post tal- amministrazzjoni Rari: edima, ksieħ.
Immune system disorders Very rare:
Disturbi fis- sistema immunitarja Rari ħafna:
anaphylaxis.
anafilassi.
Psychiatric disorders Very common: somnolence.
Disturbi psikjatriċi Komuni ħafna: ngħas.
sedation, nervousness, loss of appetite.
sedazzjoni, nervożita ’, nuqqas ta ’ aptit.
Uncommon: euphoria, amnesia, insomnia, hallucinations, agitation.
Mhux komuni: ewforija, amnesija, nuqqas ta ’ rqad, alluċinazzjonijiet, aġitazzjoni.
delusional ideas, states of excitement, asthenia, depression, anxiety, confusion, sexual dysfunction, withdrawal symptoms.
ħsibijiet delużjonali, eċċitament eċċessiv, astenja, dipressjoni, ansjeta ’, konfużjoni, anormalita ’ fil- funzjoni sesswali, sintomi assoċjati mal- waqfien mill- kura.
Other undesirable effects Not known (cannot be estimated from the available data):
Effetti mhux mixtieqa oħrajn Mhux magħrufa (ma jistgħux jiġu evalwati mit- tagħrif kurrenti):
Long-term use of fentanyl can lead to development of tolerance and physical and psychological dependence.
L- użu fit- tul ta ’ fentanyl jista ’ jwassal għal żvilupp ta ’ reżistenza u dipendenza kemm fiżika kif ukoll psikoloġika.
After switching from previously prescribed opioid analgesics to Fentanyl-ratiopharm or after abrupt discontinuation of therapy patients may show opioid withdrawal symptoms (for instance: nausea, vomiting, diarrhoea, anxiety and shivering).
Wara bidla minn analġesiċi opjojdi għall- Fentanyl- ratiopharm jew wara tmiem ħesrem tat- terapija, il- pazjenti jistgħu jezibixxu sintomi assoċjati mal- waqfien tal- kura tal- opjojdi (per eżempju: tqalliegħ, rimettar, dijarea, anzjeta ’ u tregħid).
Symptoms The symptoms of fentanyl overdose are an extension of its pharmacological actions, e. g. lethargy, coma, respiratory depression with Cheyne-Stokes respiration and/ or cyanosis.
Sintomi Is- sintomi ta ’ doża eċċessiva ta ’ fentanyl huma estensjonijiet ta ’ l- attivita` farmakoloġika ez. letarġija, koma, dipressjoni respiratorja, b’ respirazzjoni Cheyne- Stokes, u/ jew cyanosis.
Other symptoms may be hypothermia, decreased muscle tonus, bradycardia, hypotension.
Sintomi oħrajn jistgħu jkunu ipotermja, tnaqqis fit- ton tal- muskoli (ipotonija), bradikardija, pressjoni baxxa.
Signs of toxicity are deep sedation, ataxia, miosis, convulsions and respiratory depression, which is the main symptom.
Sinjali ta ’ tossiċita ’ huma sedazzjoni qawwija, ataxia, miosis, konvulżjonijiet u dipressjoni respiratorja, b’ dan ta ’ l- aħħar ikun is- sintomu ewlieni.
Treatment For management of respiratory depression immediate countermeasures should be started, including removing the patch and physically or verbally stimulating the patient.
Trattament Miżuri fil- pront għandhom jittieħdu kontra d- dipressjoni respiratorja, li jinkludu it- tneħħija tal- garża u t- tqanqil fiżiku u verbali tal- pazjent.
These actions can be followed by administration of a specific opioid antagonist such as naloxone.
Dan jista ’ jiġi segwit bl- amministrazzjoni ta ’ antagonista speċifika ta ’ l- opjojdi bħal ma ’ hu naloxone.
A starting dose of 0.4-2 mg naloxone hydrochloride i. v. is recommended for adults.
Id- doża inizjali rrakkomandata ghall- adulti hi 0. 4- 2 mg naloxone hydrochloride mogħtija minn ġol- vina.
If needed, a similar dose can be given every 2 or 3 minutes, or be administered as continued infusion as 2 mg in 500 ml sodium chloride 9 mg/ ml (0.9%) solution for injection or glucose 50 mg/ ml (5%) solution.
Jekk ikun hemm il- bżonn, doża simili tista ’ tingħata kull 2- 3 minuti, inkella tista ’ tiġi amministrata bħala infużjoni kontinwa ta ’ 2mg ġo 500ml sodium chloride 9mg/ ml (0. 9%) soluzzjoni
The infusion rate should be adjusted according to previous bolus injections and the individual response of the patient.
Ir- rata ta ’ infużjoni trid tiġi aġġustata skond l- injezzjonijiet bolus meħuda qabel u r- rispons individwali tal- pazjent.
If intravenous administration is impossible, naloxone hydrochloride can also be given intramuscularly or subcutaneously.
Jekk l- amministrazzjoni minn ġol- vina ma tkunx possibli, naloxone hydrochloride jista ’ jingħata wkoll fil- muskolu jew taħt il - ġilda.
Following intramuscular or subcutaneous administration the onset of action will be slower compared with intravenous administration.
L- effett, wara l- amministrazzjoni ġol- muskolu jew taħt il- ġilda, idum iktar biex jibda jinħass meta mqabbel ma ’ dak ta ’ wara l- amministrazzjoni minn ġol- vina.
Intramuscular administration will give a more prolonged effect than intravenous administration.
L- effett wara l- amministrazzjoni ġol- muskolu idum iktar fit- tul meta mqabbel ma ’ dak ta ’ wara l- amministrazzjoni minn ġol- vina.
Respiratory depression due to overdose can persist longer than the effect of the opioid antagonist.
Dipressjoni respiratorja minħabba doża eċċessiva tista ’ ddum iktar mill- effett ta ’ l- antagonista ta ’ l- opjojdi.
Reversing the narcotic effect can give rise to acute pain and release of catecholamines.
L- inverzjoni tal- effett narkotiku tista ’ tirriżulta f’ uġigħ akut u l- liberazzjoni ta ’ catecholamines.
Intensive care unit treatment is important, if required by the patient’ s clinical condition.
Kura intensiva hija importanti jekk din tkun meħtieġa minħabba l- kundizzjoni klinika tal- pazjent.
If severe or persistent hypotension occurs, hypovolemia should be considered, and the condition should be managed with appropriate parenteral fluid therapy.
Jekk ikun hemm pressjoni baxxa qawwija jew persistenti, għandha tiġi kkunsidrata l - possibilita ’ ta ’ ipovolimja, u din il- kundizzjoni trid tiġi mmaneġġjata bit- terapija fluwida u parenterali xierqa.
Pharmacotherapeutic group: opioids; Phenylpiperidine derivatives, ATC code:
Kategorija farmakoterapewtika: opjojdi; derivattivi ta ’ Phenylpiperidine, Kodiċi ATC:
Fentanyl is an opioid analgesic which interacts predominantly with the µ-receptor.
Fentanyl huwa analġesiku tal- klassi opjojdi li jinteraġixxi l- aktar ma ’ l- µ- receptor.
Its principal therapeutic effects are analgesia and sedation.
L- effetti prinċipali huma analġesija u sedazzjoni.
The serum concentrations of fentanyl that cause a minimal analgesic effect in opioid-naive patients fluctuate between 0.3– 1.5 ng/ ml; an increased incidence of adverse reactions is observed if serum levels exceed 2 ng/ ml.
Il- konċentrazzjoni ta ’ fentanyl fis- serum, li tikkawża effett minimu ta ’ analġesija f’ pazjenti li qed jirċievu opjojdi għall- ewwel darba, tvarja bejn 0. 3- 1. 5ng/ ml; isseħħ żieda fl- inċidenza ta ’ reazzjonijiet avversi meta l- livelli fis- serum jiskorru 2ng/ ml.
Both the lowest effective fentanyl concentration and the concentration causing adverse reactions will increase with the development of increasing tolerance.
Kemm l- inqas doża effettiva ta ’ fentanyl, kif ukoll il- konċentrazzjoni minima li tikkawża reazzjonijiet avversi, jiżdiedu hekk kif tiżviluppa żieda fit- tolleranza.
The tendency to develop tolerance varies considerably between individuals.
Hemm differenzi kbar fit- tendenza għal l- iżvilupp ta ’ tolleranza bejn pażjent u ieħor.
Following administration of Fentanyl-ratiopharm, fentanyl is continuously absorbed through the skin over a period of 72 hours.
Wara l- amministrazzjoni ta ’ Fentanyl- ratiopharm, fentanyl jiġi assorbit kontinwament minn ġol- ġilda għal perijodu ta ’ 72 siegħa.
Due to the polymer matrix and the diffusion of fentanyl through the skin layers, the release rate remains relatively constant.
Kawża tal - polymer matrix u d- diffużjoni ta ’ fentanyl mis- saffi tal- ġilda, ir- rata ta ’ rħir tibqa ’ relattivament kostanti.
Absorption After the first application of Fentanyl-ratiopharm, serum fentanyl concentrations increase gradually, generally levelling off between 12 and 24 hours, and remaining relatively constant for the remainder of the 72-hour application period.
Assorbiment Wara l- ewwel applikazzjoni ta ’ Fentanyl- ratiopharm, il- konċentrazzjoni ta ’ fentanyl fis- serum tiżdied b’ mod gradwali, issir livell bejn 12 u 24 siegħa wara, u tibqa ’ relattivament kostanti għall- bqija tal - perijodu ta ’ l- applikazzjoni ta ’ 72 siegħa.
For all practical purposes by the second 72-hour application, a steady state serum concentration is reached and is maintained during subsequent applications of a patch of the same size.
Fil- prattika, sat- tieni applikazzjoni ta’ 72 siegħa, il- konċentrazzjoni fissa fis- serum diġa ’ tkun intlaħqet u din tiġi miżmuma tul l- applikazzjonijiet sussegwenti b’ garża ta ’ l - istess daqs.
Distribution The plasma protein binding for fentanyl is 84%.
Distribuzzjoni Il- perċentwal ta ’ fentanyl li jeħel mal- proteini tad- demm huwa 84%.
Biotransformation Fentanyl is metabolized primarily in the liver via CYP3A4.
Biotrasformazzjoni Fentanyl jiġi metabolizzat primarjament fil- fwied minn CYP3A4.
The major metabolite, norfentanyl, is inactive.
Il- metabolit prinċipali, norfentanyl, m’ huwiex attiv.
Elimination When treatment with Fentanyl-ratiopharm is withdrawn, serum fentanyl concentrations decline gradually, falling approximately 50% in 13-22 hours in adults or 22-25 hours in children, respectively.
Eliminazzjoni Meta titwaqqaf il- kura bil- Fentanyl- ratiopharm il- konċentrazzjoni ta ’ fentanyl fis- serum taqa ’ gradwalment, u titbaxxa b’ madwar 50% fit- 13 sa 22 siegħa fl- adulti jew fit- 22 sa 25 siegħa fit- tfal, rispettivament.
Continued absorption of fentanyl from the skin accounts for a slower reduction in serum concentration than is seen after an intravenous infusion.
L- assorbiment ta ’ fentanyl li jissokta mill- ġilda jispjega għaliex ir- rata ta ’ tnaqqis tal- konċentrazzjoni fis- serum hija inqas minn dik osservata wara infużjoni minn ġol- vina.
Around 75% of fentanyl is excreted into the urine, mostly as metabolites, with less than 10% as unchanged active substance.
20 Madwar 75% ta ’ fentanyl jiġi eliminat fl- awrina, l- biċċa l- kbira bħala metaboliti, b’ inqas minn 10% mneħħi bħala prodott mhux mibul.
About 9% of the dose is recovered in the faeces, primarily as metabolites.
Madwar 9% mid- doża mogħtija tista ’ tiġi estratta mill- purgar, il- biċċa l- kbira bħala metaboliti.
Pharmacokinetics in special groups Elderly and debilitated patients may have reduced clearance of fentanyl leading to prolonged terminal half life.
Farmakokinetika f’ popolazzjonijiet speċjali L- anzjani u pazjenti debboli jistgħu ikollhom rata ta ’ eliminazzjoni ta ’ fentanyl baxxa li twassal għal half life terminali mtawwal.
In patients with renal or hepatic impairment, clearance of fentanyl may be altered because of changes of plasma proteins and metabolic clearance resulting in increased serum concentrations.
F’ pazjenti b’ indeboliment renali jew epatiku, jista ’ jkun hemm tibdil fir - rata ta ’ eliminazzjoni ta ’ fentanyl, minnħabba bidliet fil- proteini tal- plażma u t- tneħħija metabolika, li jwassal għal żieda tal- konċentrazzjonijiet fis- serum.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Tagħrif mhux kliniku, bbażat fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, ma ’ juri l- ebda periklu speċjali għall- bnedmin, l- ebda effett tossiku minn dożi ripetuti u l- ebda effett tossiku fuq il - ġeni.
Animal studies have shown reduced fertility and increased mortality in rat foetuses.
Studji fuq annimali urew fertilita ’ mnaqqsa u żieda fil- mortalita ’ tal- fetu tal- ġrieden.
Teratogenic effects have, however, not been demonstrated.
Mandankollu, effetti teratoġeniċi ma ġewx stabbiliti.
Long-term carcinogenicity studies have not been performed.
Studji fit- tul dwar attivita 'karċinoġenika ma twettqux.
Adhesive layer Polyacrylate adhesive layer
Saff li jwaħħal Saff li jwaħħal magħmul minn Polyacrylate
Backing film Polypropylene foil Blue printing ink
Fojl warrani Fojl magħmul minn Polypropylene Linka għall- istampar kaħlanija
Release liner Polyethylene terephthalate foil (siliconised)
Release liner Fojl magħmul minn Polyethylene terephthalate (bis- silicone)
Do not store above 25 °C.
Taħżinx f’ temperatura ’ l fuq minn 25°C
Each transdermal patch is packed in a separate sachet.
Kull garża transdermali hija ippakkjata għaliha ġo qartas separat.
The Composite foil containing the following layers from outside to inside: coated Kraft paper, low density polyethylene foil, aluminium foil, Surlyn (thermoplastic ethylene-methacrylic acid copolymer).
Il- fojl Composite huwa magħmul minn dawn is- saffi, minn barra għal ġewwa: karta Kraft miksija, fojl ta ’ polyethylene b’ densita ’ baxxa, fojl ta ’ l- aluminju, Surlyn (thermoplastic ethylene- methacrylic acid copolymer).
Pack containing 3, 5, 10 or 20 transdermal patches
Pakketti li fihom 3, 5, 10 jew 20 garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda
6.6 Special precautions for disposal
21 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
High quantities of fentanyl remain in the transdermal patches even after use.
Kwantitajiet kbar ta’ fentanyl jibqgħu fil- garża transdermali wkoll wara l- użu tagħha.
Used transdermal patches should be folded with the adhesive surfaces inwards and discarded or whenever possible returned to the pharmacy.
Il- garża wżata trid tkun mitwija bin- naħat li jwaħħlu fuq il- parti ta’ ġewwa u tintrema, jew meta jkun possibli, tittieħed lura għand is- spiżjar.
Any unused medicinal product should be discarded or returned to the pharmacy.
Kull fdalijiet tal- prodott li ma jiġux użati għandhom jintremew jew jittieħdu lura għand l- ispiżjar.
{Name and address} {tel} {fax} {e-mail}
{Isem u indirizz} {telefon} {fax} {e- mail}
21 [To be completed nationally]
[Biex timtela mill- pajjiż partikolari]
DATE OF FIRST AUTHORIZATION/ RENEWAL OF THE AUTHORIZATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI
Fentanyl-ratiopharm 50 µg/ h Matrixpflaster and associated names (see Annex I)
Fentanyl- ratiopharm 50 µg/ h Matrixpflaster u ismijiet assoċjati miegħu (Ara Anness I)
Each patch releases 50 micrograms fentanyl per hour.
Kull garża terħi 50 mikrogramma fentanyl fis- siegħa.
Each patch of 15 cm2 contains 8.25 mg fentanyl.
Kull garża ta ’ 15 cm2 fiha 8. 25 mg fentanyl.
Transparent and colourless patch with blue imprint on the backing foil: “ fentanyl 50 µg/ h“.
Garża trasparenti u bla kulur b’ sinjal kaħlani fuq il- fojl warrani: “ fentanyl 50 µg/ h “.
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)
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)
23 Table 1:
23 Tabella 1:
dose (mg/ 24 h)
Doża ta ’ morfina orali
Transdermal fentanyl release (micrograms/ h)
Irħir ta ’ fentanyl transdermali
Oral morphine dose (mg/ 24 h)
Doża ta ’ morfina orali
24 By combining several transdermal patches, a fentanyl release rate of over 100 micrograms/ h can be achieved.
24 Bit- taħlit ta ’ bosta biċċiet ta’ garża transdermali, tista ’ tinkiseb rata ta ’ irħir ta ’ fentanyl il fuq minn 100 mikrogramma fis- siegħa.
The analgesic effect may persist for some time after removal of the transdermal patch.
25 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.
25 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.
26 As with all potent opioids some patients may experience respiratory depression with Fentanyl- ratiopharm, and patients must be observed for this effect.
26 Minkejja kura b’ garza ta ’ fentanyl, stħarriġ wera li kważi l- pazjenti kollha jkollhom bżonn ta ’ mediċini qawwija u li jaħdmu fil- pront sabiex jilqgħu immedjatament kontra l- ħruġ ta ’ uġigħ mhux mistenni.
However, studies of fentanyl transdermal patch in elderly patients demonstrated fentanyl pharmacokinetics which did not differ significantly from young patients although serum concentrations tended to be higher.
27 bl- użu tal- Fentanyl transdermal patch f’ pazjenti anzjani, irriżulta li ma kienx hemm differenza sinjifikanti fil- parametri farmakokinetiċi ħdejn pazjenti żgħar, għalkemm il- konċentrazzjonijiet fis - serum kellhom tendenza li jkunu ogħla.
27 Lactation As fentanyl is excreted into breast milk, lactation should be discontinued under treatment with Fentanyl-ratiopharm (see also section 4.6).
Peress illi fentanyl jiġi eliminat fil- ħalib tal- omm, it- treddiegħ għandu jitwaqqaf waqt kura bil- Fentany- ratiopharm (ara sezzjoni 4. 6)
Increased plasma concentrations were, however, observed in individual subjects.
28 f’ xi individwi, ġew osservati żiediet tal- konċentrazzjoni fil- plażma.
28 The safety of fentanyl in pregnancy has not been established.
Is- sigurta ’ fl- użu ta ’ fentanyl fit- tqala għada ma gietx stabbilita.
Common:
29 Komuni:
29 Common:
Komuni:
Around 75% of fentanyl is excreted into the urine, mostly as metabolites, with less than 10% as unchanged active substance.
31 Madwar 75% ta ’ fentanyl jiġi eliminat fl- awrina, l- biċċa l- kbira bħala metaboliti, b’ inqas minn 10% mneħħi bħala prodott mhux mibul.
6.6 Special precautions for disposal
32 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
32 [To be completed nationally]
[Biex timtela mill- pajjiż partikolari]
Fentanyl-ratiopharm 75 µg/ h Matrixpflaster and associated names (see Annex I)
Fentanyl- ratiopharm 75 µg/ h Matrixpflaster u ismijiet assoċjati miegħu (Ara Anness I)
Each patch releases 75 micrograms fentanyl per hour.
Kull garża terħi 75 mikrogramma fentanyl fis- siegħa.
Each patch of 22.5 cm2 contains 12.375 mg fentanyl.
Kull garża ta ’ 22. 5 cm2 fiha 12. 375 mg fentanyl.
Transparent and colourless patch with blue imprint on the backing foil: “ fentanyl 75 µg/ h“.
Garża trasparenti u bla kulur b’ sinjala kaħlani fuq il- fojl warrani: “ fentanyl 75 µg/ h “.
34 Table 1:
34 Tabella 1:
35 By combining several transdermal patches, a fentanyl release rate of over 100 micrograms/ h can be achieved.
35 Bit- taħlit ta ’ bosta biċċiet ta’ garża transdermali, tista ’ tinkiseb rata ta ’ irħir ta ’ fentanyl il fuq minn 100 mikrogramma fis- siegħa.
The analgesic effect may persist for some time after removal of the transdermal patch.
36 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.
36 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.
37 As with all potent opioids some patients may experience respiratory depression with Fentanyl- ratiopharm, and patients must be observed for this effect.
37 Minkejja kura b’ garza ta ’ fentanyl, stħarriġ wera li kważi l- pazjenti kollha jkollhom bżonn ta ’ mediċini qawwija u li jaħdmu fil- pront sabiex jilqgħu immedjatament kontra l- ħruġ ta ’ uġigħ mhux mistenni.
However, studies of fentanyl transdermal patch in elderly patients demonstrated fentanyl pharmacokinetics which did not differ significantly from young patients although serum concentrations tended to be higher.
38 bl- użu tal- Fentanyl transdermal patch f’ pazjenti anzjani, irriżulta li ma kienx hemm differenza sinjifikanti fil- parametri farmakokinetiċi ħdejn pazjenti żgħar, għalkemm il- konċentrazzjonijiet fis - serum kellhom tendenza li jkunu ogħla.
38 Lactation As fentanyl is excreted into breast milk, lactation should be discontinued under treatment with Fentanyl-ratiopharm (see also section 4.6).
Peress illi fentanyl jiġi eliminat fil- ħalib tal- omm, it- treddiegħ għandu jitwaqqaf waqt kura bil- Fentany- ratiopharm (ara sezzjoni 4. 6)
Increased plasma concentrations were, however, observed in individual subjects.
39 f’ xi individwi, ġew osservati żiediet tal- konċentrazzjoni fil- plażma.
39 The safety of fentanyl in pregnancy has not been established.
Is- sigurta ’ fl- użu ta ’ fentanyl fit- tqala għada ma gietx stabbilita.
Common:
40 Komuni:
40 Common:
Komuni:
Around 75% of fentanyl is excreted into the urine, mostly as metabolites, with less than 10% as unchanged active substance.
42 Madwar 75% ta ’ fentanyl jiġi eliminat fl- awrina, l- biċċa l- kbira bħala metaboliti, b’ inqas minn 10% mneħħi bħala prodott mhux mibul.
6.6 Special precautions for disposal
43 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
Fentanyl-ratiopharm 100 µg/ h Matrixpflaster and associated names (see Annex I)
Fentanyl- ratiopharm 100 µg/ h Matrixpflaster u ismijiet assoċjati miegħu (Ara Anness I)
Each patch releases 100 micrograms fentanyl per hour.
Kull garża terħi 100 mikrogramma fentanyl fis- siegħa.
Each patch of 30 cm2 contains 16.5 mg fentanyl.
Kull garża ta ’ 30 cm2 fiha 16. 5 mg fentanyl.
Transparent and colourless patch with blue imprint on the backing foil: “ fentanyl 100 µg/ h“.
Garża trasparenti u bla kulur b’ sinjal kaħlani fuq il- fojl warrani: “ fentanyl 100 µg/ h “.
45 Table 1:
45 Tabella 1:
46 By combining several transdermal patches, a fentanyl release rate of over 100 micrograms/ h can be achieved.
46 Bit- taħlit ta ’ bosta biċċiet ta’ garża transdermali, tista ’ tinkiseb rata ta ’ irħir ta ’ fentanyl il fuq minn 100 mikrogramma fis- siegħa.
The analgesic effect may persist for some time after removal of the transdermal patch.
47 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.
47 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.
48 As with all potent opioids some patients may experience respiratory depression with Fentanyl- ratiopharm, and patients must be observed for this effect.
48 Minkejja kura b’ garza ta ’ fentanyl, stħarriġ wera li kważi l- pazjenti kollha jkollhom bżonn ta ’ mediċini qawwija u li jaħdmu fil- pront sabiex jilqgħu immedjatament kontra l- ħruġ ta ’ uġigħ mhux mistenni.
However, studies of fentanyl transdermal patch in elderly patients demonstrated fentanyl pharmacokinetics which did not differ significantly from young patients although serum concentrations tended to be higher.
49 bl- użu tal- Fentanyl transdermal patch f’ pazjenti anzjani, irriżulta li ma kienx hemm differenza sinjifikanti fil- parametri farmakokinetiċi ħdejn pazjenti żgħar, għalkemm il- konċentrazzjonijiet fis - serum kellhom tendenza li jkunu ogħla.
49 Lactation As fentanyl is excreted into breast milk, lactation should be discontinued under treatment with Fentanyl-ratiopharm (see also section 4.6).
Peress illi fentanyl jiġi eliminat fil- ħalib tal- omm, it- treddiegħ għandu jitwaqqaf waqt kura bil- Fentany- ratiopharm (ara sezzjoni 4. 6)
Increased plasma concentrations were, however, observed in individual subjects.
50 f’ xi individwi, ġew osservati żiediet tal- konċentrazzjoni fil- plażma.
50 The safety of fentanyl in pregnancy has not been established.
Is- sigurta ’ fl- użu ta ’ fentanyl fit- tqala għada ma gietx stabbilita.
Common:
51 Komuni:
51 Common:
Komuni:
Around 75% of fentanyl is excreted into the urine, mostly as metabolites, with less than 10% as unchanged active substance.
53 Madwar 75% ta ’ fentanyl jiġi eliminat fl- awrina, l- biċċa l- kbira bħala metaboliti, b’ inqas minn 10% mneħħi bħala prodott mhux mibul.
6.6 Special precautions for disposal
54 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
54 [To be completed nationally]
[Biex timtela mill- pajjiż partikolari]
55 LABELLING
55 TIKKETTA
56 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
56 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON BOX
KAXXA TAL- KARTUN
Polyacrylate adhesive layer Polypropylene foil Blue printing ink Polyethylene terephthalate foil (siliconised)
Saff li jwaħħal magħmul minn Polyacrylate Fojl magħmul minn Polypropylene Linka għall- istampar kaħlanija Fojl magħmul minn Polyethylene terephthalate (bis- silicone)
3 transdermal patches 5 transdermal patches 10 transdermal patches 20 transdermal patches
3 garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda 5 garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda 10 garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda 20 garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda
Please fill in date and time when you put your patch on.
Jekk jogħġbok niżżel d- data u l- ħin meta tilbes il- garża.
[3 transdermal patches:]
[3 garża transdermali:]
[5 transdermal patches:]
[5 garża transdermali:]
patches:]
57 [10 garża transdermali:]
[20 transdermal patches:]
[20 garża transdermali:]
Time Date
Ħin Data
Fold used patches and discard or return to the pharmacy.
Itwi l- garża wżata u armiha, jew ħudha lura għand l- ispiżjar.
{Name and Address} {tel} {fax} {e-mail}
{Isem u indirizz} {telefon} {fax} {e- mail}
59 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
59 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
[See Annex I - To be completed nationally]
[Ara Anness I - Biex timtela mill- pajjiż partikolari] >
Do not store above 25 °C.
60 Taħżinx f’ temperatura ’ l fuq minn 25°C
Fold used patches and discard or return to the pharmacy.
Itwi l- garża wżata u armiha jew ħudha lura għand l- ispiżjar.
[See Annex I - To be completed nationally]
[Biex timtela mill- pajjiż partikolari]
{Name and Address}
{Isem u indirizz}
patches:]
62 [10 garża transdermali:]
64 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
64 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Do not store above 25 °C.
65 Taħżinx f’ temperatura ’ l fuq minn 25°C
66 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
66 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
patches:]
67 [10 garża transdermali:]
69 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
69 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Do not store above 25 °C.
70 Taħżinx f’ temperatura ’ l fuq minn 25°C
71 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
71 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
patches:]
72 [10 garża transdermali:]
74 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
74 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Do not store above 25 °C.
75 Taħżinx f’ temperatura ’ l fuq minn 25°C