qanastek/EMEA-V3 huggingface dataset:
If inadequate pain relief is obtained with 2 x 100 microgram sublingual tablets, an increase in dose to the next higher available strength for the next episode of breakthrough pain should be considered.
Jekk ma jkunx hemm serħan mill- uġigħ adegwat b’ 2 pilloli ta ’ 100 mikrogramma għal taħt l- ilsien, għandu jiġi kkonsidrat li għandu jkun hemm żieda fid- doża għall- episodju li jmiss ta ’ uġigħ sfondat.
Dose escalation should continue in a stepwise manner until adequate analgesia is achieved.
Iż- żieda fid- doża għandu jkompli fi stadji sakemm tintlaħaq analġesja adegwata.
This titration should follow the course of administering a single sublingual tablet, with administration of a supplemental second sublingual tablet after 15-30 minutes, if inadequate pain relief is obtained.
Din it- tittrazzjoni għandha ssegwi l- kors ta ’ l- għoti ta ’ doża ta ’ pillola waħda għal taħt l- ilsien, bl- għoti tat- tieni pillola supplimentali ta ’ taħt l- ilsien wara 15- 30 minuta, jekk ma jkunx hemm serħan mill- uġigħ.
The dose strength for the supplemental sublingual tablet should be increased from 100 to 200 micrograms at doses of 400 micrograms and higher.
Il- qawwa tad- doża għandha tiżdied minn 100 sa 200 mikrogramma f’ dożi ta ’ 400 mikrogramma u ogħla.
This is illustrated in the schedule below.
Dan hu illustrat fl- iskeda t’ hawn taħt.
No more than two (2) sublingual tablets should be administered for a single episode of breakthrough pain during this titration phase.
Mhux aktar minn żewġ (2) pilloli għal taħt l- ilsien għandhom jingħataw għal episodju wieħed ta ’ uġigħ sfondat waqt din il- fażi ta ’ tittrazzjoni.
Strength (micrograms) of first sublingual
Qawwa (mikrogrammi) ta ’ l- ewwel pillola
Strength (micrograms) of supplemental
Qawwa (mikrogrammi) (tat- tieni) pillola
tablet per episode of breakthrough pain
għal taħt l- ilsien għal kull episodju ta ’ uġigħ sfondat 100 200 300 400 600 800
(second) sublingual tablet to be taken 15-30 minutes after first tablet, if required
suppliemntali li trid tittieħed 15- 30 minuta wara l- ewwel pillola, jekk meħtieġ 100 100 100 200 200 -
If adequate analgesia is achieved at the higher dose, but undesirable effects are considered unacceptable, an intermediate dose (using the 50 microgram or 100 microgram sublingual tablet where appropriate) may be administered.
Jekk analġesja xierqa tintlaħaq fid- doża ogħla, imma effetti mhux xierqa huma kkonsidrati li mhumiex aċċettabbli, tista ’ tingħata doża intermedja (bl- għoti ta ’ pillola ta ’ 50 mikrogramma jew 100 mikrogramma meta jixraq).
Doses higher than 800 micrograms have not been evaluated in clinical studies.
Dożi ogħla minn 800 mikrogramma ma ġewx evalwati fi studji kliniċi.
In order to minimise the risk of opioid– related adverse reactions and to identify the appropriate dose, it is imperative that patients be monitored closely by health professionals during the titration process.
Sabiex wieħed jimminimizza r- riskju ta ’ reazzjonijiet avversi relatati ma opjojdi u sabiex wieħed jidentifika d- doża xierqa, huwa imperattiv li l- pazjenti jiġu monitorati mill- qrib minn professjonisti tas- saħħa waqt il- proċess ta ’ tittrazzjoni.
19 Maintenance therapy:
20 Terapija ta ’ manteniment:
Once an appropriate dose has been established, which may be more than one tablet, patients should be maintained on this dose and should limit consumption to a maximum of four Rapinyl doses per day.
Ġaladarba doża xierqa ġiet stabilità, li tista ’ tkun ta ’ aktar minn pillola waħda, il- pazjenti għandhom jinżammu fuq din id- doża u għandhom jirristrinġu l- konsum għal massimu ta ’ erba ’ dożi ta ’ Rapinyl kuljum.
Dose re-adjustment:
Aġġustament mill- ġdid tad- doża:
If the response (analgesia or adverse reactions) to the titrated Rapinyl dose markedly changes, an adjustment of dose may be necessary to ensure that an optimal dose is maintained.
Jekk ir- rispons (analġesja jew reazzjonijiet avversi għad- doża ttittrata ta ’ Rapinyl tinbidel b’ mod notevoli, jista ’ jkun hemm bżonn t’ aġġustament għad- doża sabiex jiġi żgurat li l- aħjar doża tibqa ’ tinżamm.
If more than four episodes of breakthrough pain are experienced per day over a period of more than four consecutive days, then the dose of the long acting opioid used for persistent pain should be re- evaluated.
Jekk aktar minn erba ’ episodji ta ’ uġigħ sfondat huma esperjenzati kuljum fuq perijodu ta ’ aktar minn erbat ijiem konsekuttivi, id- doża għal opjojdi użata minħabba uġigħ persistenti li jaġixxi fuq perijodu ta ’ żmien twil għandha tiġi evalwat mill- ġdid.
If the long acting opioid or dose of long acting opioid is changed the Rapinyl dose should be re-evaluated and re-titrated as necessary to ensure the patient is on an optimal dose.
Jekk l- opjojdi li jaġixxi għal perijodu ta ’ żmien twil jew id- doża ta ’ l- opjojdi li taġixxi fuq perijodu ta ’ żmien twil tinbidel, id- doża ta Rapinyl għandha tiġi evalwata mill- ġdid u tittrata mill- ġdid kif meħtieġ sabiex il- pazjent ikun fuq l- aħjar doża.
It is imperative that any dose re-titration of any analgesic is monitored by a health professional.
Huwa imperattiv li kull tittrazzjoni ta ’ doża mill- ġdid tiġi monitorata minn professjonist tal- kura tas- saħħa.
Discontinuation of therapy:
It- twaqqif tat- terapija:
For patients no longer requiring any opioid therapy, the Rapinyl dose should be taken into consideration before a gradual downward titration of opioids to minimise possible withdrawal effects.
Għal pazjenti li ma jinħteġux aktar terapija ta ’ opjojdi, id- doża ta ’ Rapinyl għandha tittieħed konsiderazzjoni qabel ma jkun hemm tnaqqis gradwali ’ l isfel ta ’ opjojdi sabiex jitnaqqsu kemm jista ’ l- effetti possibbli wara l- waqfien.
In patients who continue to take their chronic opioid therapy for persistent pain but no longer require treatment for breakthrough pain, Rapinyl therapy may usually be discontinued immediately.
F’ pazjenti li jkomplu bit- terapija kronika ta ’ opjojdi tagħhom minħabba uġigħ persistenti imma ma jinħteġux aktar trattament għal uġigħ sfondat, it- terpija b’ Rapinyl tista ’ ġeneralment titwaqqaf minnufih.
Use in children and adolescents:
Użu fi tfal u addoloxenti:
Rapinyl must not be used in patients less than 18 years of age due to a lack of data on safety and efficacy.
Rapinyl m’ għandux jintuża f’ pazjenti li għandhom inqas minn 18- il sena peress li m’ hemmx biżżejjed dejta dwar is- sigurtà u l- effikaċja.
Use in elderly patients Dose titration needs to be approached with particular care and patients observed carefully for signs of fentanyl toxicity (see section 4.4).
Użu f’ pazjenti anzjani It- titrazzjoni tad- doża trid issir b’ attenzjoni partikolari u l- pazjenti għandhom jiġu osservati b’ attenzjoni għal sinjali ta ’ tossiċità minn fentanyl (ara sezzjoni 4. 4).
Use in patients with renal and hepatic impairment Patients with kidney or liver dysfunction should be carefully observed for signs of fentanyl toxicity during the Rapinyl titration phase (see section 4.4).
Użu f’ pazjenti b’ indeboliment fil- kliewi u fil- fwied Pazjenti li għandhom funzjoni indebolita tal- kliewi jew tal- fwied għandhom jiġu osservati b’ attenzjoni għal sinjali ta ’ tossiċità minn fentanyl waqt il- fażi ta ’ tittrazzjoni ta ’ Rapinyl (ara sezzjoni 4. 4).
Opioid-naïve patients because of the risk of life-threatening respiratory depression.
L- użu ta ’ Rapinyl huwa kontra- indikat f’ pazjenti inġenwi li qegħdin fuq opjojdi minħabba r- riskju ta dipressjoni respiratorja li tista ’ tkun ta ’ periklu għal ħajja.
Severe respiratory depression or severe obstructive lung conditions.
Kundizzjonijiet ta ’ dipressjoni respiratorja severa jew impediment sever fil- pulmuni.
Patients and their carers must be instructed that Rapinyl contains an active substance in an amount that can be fatal to a child, and therefore to keep all tablets out of the reach and sight of children.
Il- pazjenti u min jieħu ħsiebhom għandhom jingħataw istruzzjonijiet li Rapinyl fih sustanza attiva f’ ammont li fit- tfal jista ’ jwassal għal mewt, u għalhekk il- pilloli kollha għandhom jinżammu fejn ma jintlaħqux jew ma jidhrux mit- tfal.
Due to the potentially serious undesirable effects that can occur when taking an opioid therapy such as Rapinyl, patients and their carers should be made fully aware of the importance of taking Rapinyl correctly and what action to take should symptoms of overdose occur.
Minħabba l- possibilità li jista ’ jkun hemm effetti mhux mixtieqa serji meta ttieħed it- terapija opjojdi bħal Rapinyl, il- pazjenti u min jieħu ħsiebhom għandhom ikunu konxji dwar l- importanza li Rapinyl jittieħed sew u x’ azzjoni għandha tittieħed jekk is- sintomi ta ’ doża eċċessiva jseħħu.
Before Rapinyl therapy is initiated, it is important that the patient’ s long-acting opioid treatment used to control their persistent pain has been stabilised.
21 Qabel it- terapija b’ Rapinyl tiġi mibdija, huwa importanti li t- trattament opjojdi fit- tul tal- pazjent li tingħata sabiex jiġi kontrollat l- uġigħ persistenti ikun ġie stabilizzat.
Upon repeated administration of opioids such as fentanyl, tolerance and physical and/ or psychological dependence may develop.
Ma ’ l- għoti ripetut ta ’ opjojdi bħal fentanyl, tista ’ tiżviluppa tolleranza u d- dipendenza fiżika u/ jew psikoloġika.
Iatrogenic addiction following therapeutic use of opioids is rare.
Vizzju ijatroġeniku wara l- użu terapewtiku ta ’ opjojdi huwa rari.
20 In common with all opioids, there is a risk of clinically significant respiratory depression associated with the use of Rapinyl.
B’ mod komuni ma ’ l- opjojdi kollha, hemm riskju sinifikanti kliniku ta ’ dipressjoni respiratorja assoċjata ma ’ l- użu ta ’ Rapinyl.
Particular caution should be exercised during dose titration with Rapinyl in patients with chronic obstructive pulmonary disease or other medical conditions predisposing them to respiratory depression (e. g. myasthenia gravis) because of the risk of further respiratory depression, which could lead to respiratory failure.
Attenzjoni partikolari għandha tiġi eżerċitata waqt tittrazzjoni tad- doża f’ pazjenti li għandhom mard pulmonari ostruttiv kroniku jew kundizzjonijiet mediċi li jippredisponuhom għal dipressjoni respiratorja (eż. majastenja gravis) minħabba r- riskju akbar ta ’ dipressjoni respiratorja, li jista ’ jwassal għal falliment respiratorju.
Rapinyl should only be administered with extreme caution in patients who may be particularly susceptible to the intracranial effects of hyperkapnia, such as those showing evidence of raised intracranial pressure, reduced consciousness, coma or brain tumours.
Rapinyl għandu jingħata biss b’ attenzjoni estrema lil pazjenti li huma partikolarment suxxetibbli għall- effetti intrakranjali ta ’ iperkapnija, bħal dawk li juru evidenza ta ’ pressjoni intrakranjali mgħollija, koxjenza mnaqqsa, koma jew tumuri tal- moħħ.
In patients with head injuries, the clinical course may be masked by the use of opioids.
F’ pazjenti b’ leżjonijiet fir- ras, il- kors kliniku jista ’ jiġi mmaskrat bl- użu ta ’ opjojdi.
In such a case, opioids should be used only if absolutely necessary.
F’ każ bħal dan, l- opjojdi għandhom jintużaw biss jekk assolutament meħtieġa.
Intravenous fentanyl has been shown to cause bradycardia.
Fentanyl ġol- vina intwera li jikkaġuna bradikardja.
Rapinyl should be used with caution in patients with bradyarrhythmias.
Rapinyl għandu jintuża b’ kawtela f’ pazjenti b’ bradiarritmiji.
Data from intravenous studies with fentanyl suggest that elderly patients may have reduced clearance, a prolonged half-life and they may be more sensitive to the active substance than younger patients.
Dejta minn studji dwar fentanyl li ngħata ġol- vina jissuġerixxu li pazjenti anzjani jista ’ jkollhom rata ta ’ tneħħija mnaqqsa, half- life mtawwla u jistgħu jkunu aktar sensittivi għas- sustanza attiva minn pazjenti iżgħar.
Elderly, cachectic, or debilitated patients should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary.
Pazjenti anzjani, kaċektiċi jew debilitati għandhom ikunu osservati b’ reqqa għal sinjali ta ’ tossiċità ta ’ fentanyl u d- doża għandha tiġi mnaqqsa jekk hemm bżonn.
Rapinyl should be administered with caution to patients with liver or kidney dysfunction, especially during the titration phase.
Rapinyl għandu jiġi mogħti b’ kawtela lil pazjenti li għandhom indeboliment tal- fwied jew tal- kliewi, speċjalment waqt il- fażi ta ’ tittrazzjoni.
The use of Rapinyl in patients with hepatic or renal impairment may increase the bioavailability of fentanyl and decrease its systemic clearance, which could lead to accumulation and increased and prolonged opioid effects.
L- użu ta ’ Rapinyl f’ pazjenti b’ indeboliment tal- fwied jew tal- kliewi jista ’ jżid il- bijodisponibilità ta ’ fentanyl u jnaqqas it- tneħħija sistemika tiegħu, li jista ’ jwassal għal akkumulazzjoni u żieda u effetti opjojdi mdewwma.
Care should be taken in treating patients with hypovolaemia and hypotension.
Għandha tingħata attenzjoni meta pazjenti jiġu ttrattati għall- ipovolemja u ipotensjoni.
Rapinyl has not been studied in patients with mouth wounds or mucositis.
Rapinyl ma ġiex studjat f’ pazjenti li għandhom leżjonijiet tal- ħalq jew mukosite.
There may be a risk of increased systemic drug exposure in such patients and therefore extra caution is recommended during dose titration.
Jista ’ jkun hemm riskju għal żieda fl- espożizzjoni sistemika tal- mediċina f’ pazjenti bħal dawn u għalhekk huwa rakkomandat li jkun hemm aktar kawtela waqt it- tittrazzjoni tad- doża.
There should be no noticeable effects on cessation of treatment with Rapinyl, but possible symptoms of withdrawal are anxiety, tremor, sweating, paleness, nausea and vomiting.
M’ għandux ikun hemm effetti notevoli mat- twaqqif tat- trattament b’ Rapinyl, imma jista ’ jkun hemm sintomi bħal ansjetà, rogħda, togħrieq, sfurija, tqallih u remettar.
Fentanyl is metabolised by CYP3A4.
Fentanyl jiġi metabolizzat b’ CYP3A4.
Active substances that inhibit CYP3A4 activity such as macrolide antibiotics (e. g. erythromycin), azole antifungal agents (e. g. ketoconazole, itraconazole) or certain protease inhibitors (e. g. ritonavir) may increase the bioavailability of fentanyl by decreasing its systemic clearance, potentially enhancing or prolonging opioid effects.
Mediċini li jimpedixxu l- attività ta ’ CYP3A4 bħall- antibijotiċi makrolidi (eż. erythromycin), sustanzi ta ’ kontra l- moffa azole (eż. ketoconazole, itraconazole) jew ċertu impedituri tal- protease (eż. ritonavir) jistgħu jżidu l- bijodisponibilità ta ’ fentanyl billi jnaqqsu t- tneħħija sistemika, u b’ hekk jistgħu jħarrxu jew idewmu l- effetti opjojdi.
Grapefruit juice is also known to inhibit CYP3A4.
Il- meraq tal- grejpfrut huwa magħruf li jimpedixxi CYP3A4.
Fentanyl should therefore be given to patients with caution if administered concomitantly with CYP3A4 inhibitors.
Għalhekk fentanyl għandu jingħata lil pazjenti b’ kawtela jekk ikun qed jingħata flimkien ma ’ impedituri CYP3A4.
Concomitant use of other CNS depressants, such as other morphine derivatives (analgesics and antitussives), general anaesthetics, skeletal muscle relaxants, sedative antidepressants, sedative H1 antihistamines, barbiturates, anxiolytics (ie benzodiazepines), hypnotics, antipsychotics, clonidine and related substances may produce increased CNS depressant effects.
L- użu konkomitanti ta ’ sedattivi tas- SNĊ, bħal derivati tal- morfina (analġesiċi u antitussivi), loppju ġenerali, rilassaturi tal- muskoli skeletriċi, mediċina sedattiva kontra d- dipressjoni, sedattivi antiħistaminiċi H1, barbiturati, anksjolitiċi (ie. benzodiazepines), ipnotiċi, antipsikotiċi, clonidine u sustanzi relatati jistgħu jżidu l- effetti sedattivi tas- SNĊ.
Respiratory depression, hypotension and profound sedation may occur.
Jista ’ jkun hemm dipressjoni respiratorja, pressjoni baxxa u sedazzjoni profonda.
Alcohol potentiates the sedative effects of morphine-based analgesics, therefore concomitant administration of alcoholic beverages or medicinal products containing alcohol with Rapinyl is not recommended.
22 L- alkoħol iħarrax l- effetti sedattivi ta ’ analġesiċi li jkunu bażati fuq il- morfina, għalhekk l- għoti konkomitanti ta ’ xorb alkoħoliku jew prodotti mediċinali li fihom l- alkoħol ma ’ Rapinyl mhux rakkomandat.
Rapinyl is not recommended for use in patients who have received monoamine oxidase (MAO) inhibitors within 14 days because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics.
Rapinyl mhux rakkomandat biex jintuża f’ pazjenti li rċevew impedituri ta ’ monoamine oxidase (MAO) fi żmien 14- il jum minħabba li tħarrix sever u imprevedibbli b’ impedituri MAO ġie rapportat b’ analġesiċi opjojdi.
21 The concomitant use of partial opioid agonists/ antagonists (e. g. buprenorphine, nalbuphine, pentazocine) is not recommended.
L- użu fl- istess ħin ta ’ agonisti/ antagonisti parzjali ta ’ opjojdi (eż. buprenorphine, nalbuphine, pentazocine) mhux rakkomandat.
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 dependent patients.
Dawn għandhom affinità għolja għal riċettaturi ta ’ opjojdi b’ attività intrinsika relattivament baxxa u għalhekk jantagonizzaw l- effett analġesiku parzjali ta ’ fentanyl u jistgħu jissensitizzaw is- sintomi ta ’ waqfien f’ pazjenti dipendenti fuq opjojdi.
The safety of fentanyl in pregnancy has not been established.
Is- sigurtà ta ’ fentanyl fit- tqala ma ġietx stabilita.
Fentanyl should only be used during pregnancy when clearly necessary.
Fentanyl għandu jintuża biss waqt it- tqala meta tassew ikun hemm bżonn ċar għalih.
Long-term treatment during pregnancy may cause withdrawal symptoms in the new-born infant.
Trattament fuq perijodu ta ’ żmien twil waqt it- tqala jista ’ jikkawża sintomi ta ’ waqfien fuq it- tarbija li għadha kif twieldet.
Fentanyl should not be used during labour and delivery (including caesarean section) since fentanyl crosses the placenta and may cause respiratory depression in the foetus or in the new-born infant.
Fentanyl m’ għandux jiintuża waqt il- ħlas u t- twelid (li jinkludi b’ ċesarja) peress li fentanyl jaqsam is- sekonda u jista ’ jikkawża dipressjoni respiratorja fil- fetu jew fit- tarbija li għadha kif titwieled.
Fentanyl is excreted into breast milk and may cause sedation and respiratory depression in the breast- fed child.
Fentanyl jiġi eliminat fil- ħalib ta ’ l- omm u jista ’ jikkawża sedazzjoni u dipressjoni respiratorja fit- tarbija mredda ’.
Fentanyl should only be used by breast-feeding women if the benefits clearly outweigh the potential risks for both mother and child.
Fentanyl għandu jintuża minn nisa li qed ireddgħu kemm- il darba l- benefiċċji miksubin huma ta’ riskji potenzjali nqas kemm għall- omm u t- tarbija biss.
However, fentanyl may impair the mental or physical ability to perform potentially hazardous tasks such as driving or operating machinery.
Madankollu, fentanyl jista ’ jfixkel il- abilita mentali jew fiżiċi biex jitwettqu doveri potenzjalment perikolużi bħal sewqan u tħaddim ta ’ magni.
Patients should be advised not to drive or operate machinery if they become dizzy or drowsy or experience blurred or double vision while taking Rapinyl.
Il- pazjenti għandhom jingħataw parir biex ma jsuqux jew iħadmu magni jekk iħossuhom sturduti jew mħedla jew jesperjenzaw vista ’ mċajpra jew vista ’ doppja waqt li jkunu fuq Rapinyl.
Undesirable effects typical of opioids are to be expected with Rapinyl; they tend to decrease in intensity with continued use.
Effetti mhux mixtieqa komuni għal opjojdi għandhom ikunu mistennija b’ Rapinyl; dawn għandhom tendenza li jonqsu mill- intensità jekk jibqgħu jintużaw.
The most serious potential adverse reactions associated with opioid use are respiratory depression (which could lead to respiratory arrest), hypotension and shock.
L- aktar reazzjonijiet avversi serji assoċjati ma ’ l- użu ta ’ opjojdi huma dipressjoni respiratorja (li tista ’ twassal għal waqfien respiratorju), pressjoni baxxa u xokk.
Other very commonly reported adverse reactions include: nausea, vomiting, constipation, headache, somnolence/ fatigue and dizziness.
Reazzjonijijiet avversi oħra rapportati b’ mod komuni ħafna jinkludu: tqalligħ, remettar, stitikezza, uġigħ ta ’ ras, ħedla/ għeja u sturdament.
Adverse reactions from clinical studies with Rapinyl in patients and volunteers, with a suspected relationship to treatment, are listed below by system organ class and frequency (very common ≥ 1/ 10; common ≥ 1/ 100 to < 1/ 10).
Reazzjonijiet avversi minn studji kliniċi b’ Rapinyl f’ pazjenti u volontieri, b’ relazzjoni suspettata għat- trattament, huma elenkati hawn isfel skond is- sistema tal- klassifika tal- organi u l- frekwenza (komuni ħafna ≥ 1/ 10; komuni ≥ 1/ 100 sa < 1/ 10).
Dizziness, somnolence, headache Common:
Sturdament, ħedla, uġigħ ta ’ ras Komuni:
Vasovagal reaction, hypoaesthesia, paraesthesia, hyperacusis
Reazzjoni vażovagali, ipoestesja, paraestesja, iperakusi
Eye disorders Common:
23 Disturbi fl- għajnejn Komuni:
Vision abnormal
Vista abnormali
Respiratory depression, rhinitis, pharyngitis
Dipressjoni respiratorja, rinite, farinġite
Nausea Common:
Tqalligħ Komuni:
Vomiting, abdominal pain, diarrhoea, constipation, stomach discomfort, dyspepsia, dry mouth 22 Skin and subcutaneous tissue disorders Common:
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Komuni:
Orthostatic hypotension, flushing, hot flush
Ipotensjoni ortostatika, fwawar, fwawar sħan
Fatigue Common:
Għeja Komuni:
Asthenia, application site irritation
Astenja, irritazzjoni fis- sit ta ’ applikazzjoni
Depression, anorexia, concentration impaired, euphoria
Dipressjoni, anoreksja, konċentrazzjoni indebolita, ewforja
All the above adverse reactions were reported in opioid naïve volunteers administered with Rapinyl.
Ir- reazzjonijiet avversi kollha t’ hawn fuq kienu rapportati f’ voluntieri inġenwi li qegħdin fuq opjojdi li ngħataw permezz ta ’ Rapinyl.
Patients (n=23) treated with Rapinyl only experienced dizziness, nausea and vomiting.
Pazjenti (n=23) trattati b’ Rapinyl biss ħassew ngħas, tqalligħ u remettar.
The following adverse reactions associated with other medicinal products containing fentanyl have also been reported (very common ≥ 1/ 10; common ≥ 1/ 100 to < 1/ 10; uncommon ≥ 1/ 1000 to < 1/ 100; rare ≥ 1/ 10,000 to < 1/ 1000; very rare < 1/ 10,000; not known (cannot be estimated from available data)):
Ir- reazzjonijiet avversi li ġejjin kienu assoċjati ma ’ prodotti oħra ta ’ fentanyl li wkoll ġew rapportati (komuni ħafna ≥ 1/ 10; komuni ≥ 1/ 100 sa < 1/ 10; mhux komuni ≥ 1/ 1000 sa < 1/ 100; rari ≥ 1/ 10, 000 sa < 1/ 1000; rari ħafna < 1/ 10, 000; mhux magħrufa (ma tistax tittieħed stima mid- dejta disponibbli)):
Bradycardia, tachycardia, hypertension Very rare:
Bradikardja, takikardja, pressjoni għolja Rari ħafna:
Arrhythmias
Arritmiji
Myoclonus, insomnia, taste disorders Uncommon:
Majoklonus, nuqqas ta ’ rqad, disturbi fit- togħma Mhux komuni:
Abnormal gait/ coordination, vertigo, amnesia, speech disorders, tremor
Pass/ koordinazzjoni mhux normalit, vertiġoni, amnesija, disturbi fit- taħdit, rogħda
Respiratory thoracic and mediastinal disorders Uncommon:
Disturbi respiratorji, toraċiċi u medjastinali Mhux komuni:
Hypoventilation, asthma, dyspnoea, Very rare:
Ipoventilazzjoni, ażma, dispnea, Rari ħafna:
Apnoea, haemoptysis
Apnea, emoptisi
Gastro-intestinal occlusion, dysphagia, mouth ulcers/ stomatitis, tongue disorder Uncommon:
Disturbi gastro- intestinali Komuni: okklużjoni gastro- intestinali, disfaġja, ulċeri tal- ħalq/ stomatite, disturbi fl- ilsien Mhux komuni:
Enlarged abdomen, flatulence, thirst Rare:
Addome minfuħ, gass, għatx Rari:
Hiccups
Sulluzzu
Urinary retention, change in urinary frequency Very rare: bladder spasm, oliguria
Żamma awrinarja, bidla fil- frekwenza meta tgħaddi awrina Rari ħafna: spażmu fil- bużżieqa awrinarja, oligurja
Sweating
Tagħriq
Accidental injuries
Korriment, avvelenament u komplikazzjonijiet ta ’ xi proċedura Komuni: korrimenti aċċidentali
Vascular disorders Common:
24 Disturbi vaskulari Komuni:
Vasodilation
Twessiegħ tal- vażi tad- demm
Malaise
Tħossok ma tiflaħx
Hallucinations, confusion, anxiety, nervousness, abnormal thinking, abnormal dreams Uncommon:
Alluċinazzjonijiet, konfużjoni, ansjetà, nervożità, ħsibijiet mhux normali, ħolm mhux normali Mhux komuni:
Agitation, depersonalisation, emotional lability 23 4.9 Overdose
Aġitazzjoni, depersonalizzazzjoni, vulnerabilità emozzjonali
The symptoms of fentanyl overdose are an extension of its pharmacological actions, the most serious effect being respiratory depression, which may lead to respiratory arrest.
Is- sintomi ta ’ doża eċċessiva ta ’ fentanyl huma estensjoni ta ’ l- azzjonijiet farmakoloġiċi tiegħu, bl- aktar effett serju jkun dipressjoni respiratorja li jista ’ jwassal għal arrest respiratorju.
Management of opioid overdose in the immediate term includes removal of any remaining Rapinyl sublingual tablets from the mouth, physical and verbal stimulation of the patient and an assessment of the level of consciousness.
It- treġija ta ’ doża eċċessiva ta ’ opjojdi fil- perijodu immedjat jinkludi t- tneħħija ta ’ pilloli għal taħt l- ilsien li jkun għad fadal mill- ħalq, stimulazzjoni fiżika u verbali tal- pazjent u stima tal- livell ta ’ koxjenza.
A patent airway should be established and maintained.
Passaġġ minn fejn tgħaddi l- arja għandu jiġi stabbilit u miżmum.
If necessary an oropharyngeal airway or endotracheal tube should be inserted, oxygen administered and mechanical ventilation initiated, as appropriate.
Jekk ikun meħtieġ passaġġ orofarinġeali jew tubu endotrakeali għandu jiddaħħal, jingħata l- ossiġenu u tiġi mibdija ventilazzjoni mekkanika, kif xieraq.
Adequate body temperature and parenteral fluid intake should be maintained.
Għandha tibqa ’ tinżamm temperatura tal- ġisem xierqa u l- għoti ta ’ fluwidu parenterali.
For the treatment of accidental overdose in opioid-naïve individuals, naloxone or other opioid antagonists should be used as clinically indicated and in accordance with their Summary of Product Characteristics.
Għat- trattament ta ’ doża eċċessiva aċċidentali f’ individwi inġenwi dwar opjojdi, naloxone jew opjojdi oħra antagonisti għandhom jintużaw kif indikat klinikament u b’ konformità mas- Sommarju tal - Karatteristiċi tal- Prodott taghom.
Repeated administration of the opioid antagonist may be necessary if the duration of respiratory depression is prolonged.
L- għoti ripetut ta ’ l- antagonist opjojdi jista ’ jkun meħtieġ jekk jitwal iż- żmien tad- dipressjoni respiratorja.
Care should be taken when using naloxone or other opioid antagonists to treat overdose in opioid- maintained patients, due to the risk of precipitating an acute withdrawal syndrome.
Kura għandha tingħata meta jintuża naloxone jew antagonisti ta ’ opjojdi oħrajn sabiex tiġi kkurata doża eċċessiva f’ pazjenti li qed jinżammu fuq opjojdi, minħabba r- riskju ta ’ preċipitazzjoni tas- sindromu tat- twaqqif akut.
If severe or persistent hypotension occurs, hypovolaemia should be considered, and the condition should be managed with appropriate parenteral fluid therapy.
Jekk ikun hemm pressjoni baxxa severa jew persistenti, għandha tiġi kkonsidrata l- ipovolemja, u l- kundizzjoni għandha tiġi ġestita b’ terapija bi fluwidu parenterali xieraq.
Muscle rigidity interfering with respiration has been reported with fentanyl and other opioids.
Riġidità muskolari li tinterferixxi ma ’ respirazzjoni ġiet rapportata ma ’ fentanyl u opjojdi oħra.
In this situation, endotracheal intubation, assisted ventilation and administration of opioid antagonists as well as muscle relaxants may be requested.
F’ din is- sitwazzjoni, intubazzjoni endotrakeali, ventilazzjoni assistita u l- għoti ta ’ antagonisti opjojdi kif ukoll rilassaturi muskolari jistgħu jiġu mitluba.
Phenylpiperidine derivatives, ATC code:
Kodiċi ATC:
Fentanyl is a potent µ-opioid analgesic with rapid onset of analgesia and short duration of action.
Fentanyl huwa analġesiku qawwi tat- tip opjojdi- µ li jaġixxi malajr u fuq perijodu ta ’ żmien qasir.
Fentanyl is approximately 100-fold more potent than morphine as an analgesic.
Fentanyl huwa madwar 100 darba aktar qawwi mill- morfina bħala analġesiku.
Secondary effects of fentanyl on central nervous system (CNS), respiratory and gastro-intestinal function are typical of opioid analgesics and are considered to be class effects.
L- effetti sekondarji fuq is- sistema nervuża ċentrali (SNĊ), il- funzjoni respiratorja u gastro- intestinali huma tipiċi ta ’ opjojdi analġesiċi u huma kkonsidrati li huma effetti tal- kategorija.
The analgesic effects of fentanyl are related to the blood level of the active substance; in opioid-naïve patients, minimum effective analgesic serum concentrations of fentanyl range from 0.3-1.2 ng/ ml, while blood levels of 10-20 ng/ ml produce surgical anaesthesia and profound respiratory depression.
L- effetti analġesiċi ta ’ fentanyl huma relatati mal- livell ta ’ demm tas- sustanza attiva; f’ pazjenti inġenwi li qegħdin fuq opjojdi, il- konċentrazzjonijiet effettivi minimi fis- serum ta ’ fentanyl ivarjaw minn 0. 3- 1. 2 ng/ ml, filwaqt li l- livelli tad- demm ta ’ 10- 20 ng/ ml jipproduċu anestesija kirurġika u dipressjoni respiratorja profonda.
In patients with chronic cancer pain on stable maintenance doses of opioids, Rapinyl has been shown to induce significantly superior relief of breakthrough pain compared to placebo from 15 minutes after administration onwards, with a significantly lower need for rescue analgesic therapy.
25 F’ pazjenti b’ uġigħ dovut għal kanċer kroniku fuq dożi stabbli ta ’ manteniment ta ’ opjojdi, Rapinyl intwera li jissensitizza b’ mod sinifikanti solljev superjuri ta ’ uġigħ sfondat meta mqabbel ma ’ plaċebo wara 15- il minuta mill- għoti ’ l quddiem, bi bżonn sinifikament imnaqqas għal terapija analġesika ta ’ sopravivenza.
The safety and efficacy of Rapinyl have been evaluated in patients taking the drug at the onset of the breakthrough pain episode.
Is- sigurtà u l- effikaċja ta ’ Rapinyl ġew evalwati f’ pazjenti li kienu qed jieħdu l- mediċina malli sfonda l- episodju ta ’ l- uġigħ.
Pre-emptive use of Rapinyl for predictable pain episodes was not investigated in the clinical trials.
L- użu sabiex jilqa ’ minn qabel għal uġigħ prevedibbli b’ Rapinyl ma ġiex mistħarreġ fil- provi kliniċi.
Fentanyl, in common with all µ-opioid receptor agonists, produces dose dependent respiratory depression.
Fentanyl, bħal fil- każ ta ’ l- agonisti riċettaturi opjojdi- µ kollha, jipproduċi dipressjoni respiratorja li tiddependi mid- doża mogħtija.
This risk is higher in opioid-naïve subjects than in patients experiencing severe pain or receiving chronic opioid therapy.
Dan ir- riskju hu ogħla f’ individwi inġenwi dwar l- opjojdi milli f’ pazjenti li jħossu uġigħ sever jew li qed jirċievu terapija kronika ta ’ opjojdi.
Long-term treatment with opioids typically leads to development of tolerance to their secondary effects.
Trattament fuq tul ta ’ żmien b’ opjojdi ġeneralment iwassal għal tolleranza ta ’ l- effetti kollaterali tagħhom.
24 While opioids generally increase the tone of urinary tract smooth muscle, the net effect tends to be variable, in some cases producing urinary urgency, in others, difficulty in urination.
Filwaqt li l- opjojdi ġeneralment iżidu t- ton tal- muskolu mieles tal- passaġġ urinarju, l- effett nett għandu tendenza li jkun varjabbli, f’ xi każijiet jipproduċi urġenza urinarja, f’ każijiet oħra diffikultà biex tgħaddi l- urina.
Opioids increase the tone and decrease the propulsive contractions of the smooth muscle of the gastrointestinal tract leading to a prolongation in gastrointestinal transit time, which may be responsible for the constipating effect of fentanyl.
L- opjojdi jżidu t- ton u jnaqqsu l- kontrazzjonijiet propulsivi tal- muskolu mieles tal- passaġġ gastro- intestinali li jwassal għal dewmin fil- ħin ta ’ transizzjoni gastro- intestinali, li jista ’ jkun responsabbli għall- effett stitiku ta ’ fentanyl.
Fentanyl is a highly lipophilic drug absorbed very rapidly through the oral mucosa and more slowly through the gastrointestinal tract.
Fentanyl huwa mediċina lipofilika hafna li jiġi assorbit malajr mill- mukosa tal- ħalq u aktar bil- mod permezz tal- passaġġ gastro- intestinali.
Orally administered fentanyl undergoes pronounced hepatic and intestinal first pass effects.
Fentanyl li jingħata mill- ħalq jgħaddi minn tibdil notevoli ta ’ l - 1st pass effect fil- fwied u fl- imsaren.
Rapinyl is a quick dissolving sublingual tablet formulation.
Rapinyl hija formulazjoni ta ’ pillola għal taħt l- ilsien li tinħall malajr.
Rapid absorption of fentanyl occurs over about 30 minutes following administration of Rapinyl.
Fentanyl jiġi assorbit malajr f’ madwar 30 minuta minn wara t- teħid ta ’ Rapinyl.
The bioavailability of Rapinyl has not been studied but is estimated to be about 70%.
Il- bijodisponibilità ta ’ Rapinyl għadha ma ġietx studjata imma hija stmata li hi ta ’ madwar 70%.
Mean maximal plasma concentrations of fentanyl range from 0.2 to 1.3 ng/ ml (after administration of 100 to 800 µg Rapinyl) and are reached within 22.5 to 240 minutes.
Il- konċentrazzjonijiet massimi medji ta ’ fentanyl fil - plazma ivarjaw minn 0. 2 sa 1. 3 ng/ ml (wara l- għoti ta ’ 100 sa 800 µg Rapinyl) u jintlaħqu bejn 22. 5 sa 240 minuta wara.
About 80-85% of fentanyl is bound by plasma proteins, mainly α 1-glycoprotein and to a lesser extent albumin and lipoprotein.
Madwar 80- 85% ta ’ fentanyl jintrabat mal- proteini fil- plażma, prinċipalment ma ’ α1- glycoprotein u fi proporzjon ferm inqas ma ’ l- albumina u lipoproteina.
The volume of distribution of fentanyl at steady state is about 3-6 l/ kg.
Il- volum ta ’ distribuzzjoni ta ’ fentanyl fi stadju fiss hu ta ’ madwar 3- 6 l/ kg.
Fentanyl is metabolised primarily via CYP3A4 to a number of pharmacologically inactive metabolites, including norfentanyl.
Fentanyl huwa metabolizzat prinċipalment permezz ta ’ CYP3A4 f’ għadd ta ’ metaboliti farmakoloġikament mhux attivi, li jinkludu norfentanyl.
Within 72 hours of intravenous fentanyl administration around 75% of the dose is excreted into the urine, mostly as metabolites, with less than 10% as unchanged drug.
Fi żmien 72 siegħa mit- teħid ġol- vina ta ’ fentanyl madwar 75% tad- doża tiġi eliminata fl- awrina, prinċipalment bħala metaboliti, b’ inqas minn 10% bħala l- mediċina mhux mibdula.
About 9% of the dose is recovered in the faeces, primarily as metabolites.
Madwar 9% tad- doża ġiet rkuprata mill- ippurgar, prinċipalment bħala metaboliti.
Total plasma clearance of fentanyl is about 0.5 l/ h/ kg.
It- tneħħija totali fil- plażma ta ’ fentanyl hi ta ’ madwar 0. 5 l/ h/ kg.
After Rapinyl administration, the main elimination half-life of fentanyl is about 7 hours (range 3-12.5 hours) and the terminal half-life is about 20 hours (range 11.5-25 hours).
Wara l- għoti ta ’ Rapinyl, il- half- life ta ’ l- eliminazzjoni medja hi ta ’ madwar 7 sigħat (medda ta ’ 3- 12. 5 sigħat) u l- half life terminali hi ta ’ madwar 20 siegħa (medda 11. 5- 25 siegħa).
The pharmacokinetics of Rapinyl have been shown to be dose proportional over the dose range of 100 to 800 µg.
Il- farmakokinetiċi ta ’ Rapinyl intwerew li huma proporzjonali għad- doża fuq il- firxa ta ’ dożi ta ’ bejn 100 sa 800 µg.
Renal/ hepatic impairment Impaired hepatic or renal function could cause increased serum concentrations.
Farmakokinetiċi fi gruppi speċjali Indeboliment fil- funzjoni epatika jew renali tista ’ twassal għal konċentrazzjonijiet ogħla fis- serum.
Elderly, cachectic or generally impaired patients may have a lower fentanyl clearance, which could cause a longer terminal half-life for the compound (see sections 4.2 and 4.4).
Pazjenti anzjani, kaċetiċi jew indeboliti b’ mod ġenerali jista ’ jkollhom rata ta ’ tneħħija ta ’ fentanyl aktar baxxa, li jista ’ jwassal għal half- life terminali itwal għall- kompost (ara sezzjonijiet 4. 2 u 4. 4).
5.3 Preclinical safety data
26 5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Safety pharmacology and repeated dose toxicity data reveal no special hazard for humans that is not already covered by other sections of this SPC.
Dejta dwar is- sigurtà farmakoloġika u tossiċità minħabba dożi ripetuti ma wera ebda ħsara speċjali għal bniedem li mhix diġà koperta f’ sezzjonijiet oħra ta ’ dan is- SKP.
Animal studies have shown reduced fertility and increased mortality in rat foetuses.
Studji fuq l- annimali wrew fertilità mnaqqsa u żieda fl- imwiet tal- feti fil- firien.
Teratogenic effects have, however, not been demonstrated.
Madankollu, effetti teratoġeniċi ma ntwerewx.
Mutagenicity testing in bacteria and in rodents yielded negative results.
Testijiet mutaġeniċi f’ batterja u f’ annimali gerriema taw riżultati negattivi.
Like other opioids fentanyl showed mutagenic effects in vitro in mammalian cells.
Bħal opjojdi oħra fentanyl wera effetti mutaġeniċi in vitro fiċ- ċelluli mammiferi.
A mutagenic risk with therapeutic use seems unlikely since effects were induced only at very high concentrations.
Riskju mutaġeniku b’ użu terapewtiku jidher improbabbli peress li l- effetti kienu sensitizzati biss f’ konċentrazzjonijiet għoljin.
Long-term carcinogenicity studies have not been performed.
Studji karċinoġeniku fuq perijodu ta ’ żmien twil ma sarux.
Mannitol (E421) Silicified microcrystalline cellulose Croscarmellose sodium
Mannitol (E421) Silicified microcrystalline cellulose Croscarmellose sodium Magnesium stearate
Store in the original blister package in order to protect from moisture.
Aħżen fil- pakkett ta ’ folji oriġinali sabiex tilqa ’ mill- umdità.
Rapinyl sublingual tablets are packaged in OPA/ PVC/ aluminium/ aluminium blisters contained in a cardboard outer carton.
Il- pilloli għal taħt l- ilsien ta ’ Rapinyl huma ppakkjati f’ folji ta ’ OPA/ PVC/ aluminju/ aluminju li jinsabu f’ kartuna fuq barra tal- kardbord.
The packaging is colour-coded for each Rapinyl sublingual tablet strength.
Il- pakkett huwa kodifikat skond il- kulur għal kull qawwa ta ’ pillola għal taħt l- ilsien ta ’ Rapinyl.
Pack size:
Id- daqs tal- pakketti:
Packs of 10 or 30 sublingual tablets.
Pakketti ta ’ 10 jew 30 pillola għal taħt l- ilsien.
Not all pack sizes may be marketed
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali
Waste material should be disposed of safely.
Materjal ta ’ skart għandu jintrema b’ mod sikur.
Patients/ carers should be encouraged to return any unused product to the Pharmacy, where it should be disposed of in accordance with national and local requirements.
Il- pazjenti/ min jieħu ħsiebhom għandhom jiġu inkorraġiti jirritornaw kull prodott li ma ntużax lura lill- Ispiżerija, fejn għandu jintrema b’ mod konformi mal- ħtiġijiet nazzjonali u lokali.
[See Annex I - To be completed nationally] {Name and address }< {tel }> < {fax }> < {e-mail }>
[Ara Anness I - Biex jimtela mill- pajjiż partikolari] {Isem u indirizz} < {tel} > < {faks} > < {posta elettronika} >
26 LABELLING
28 TIKKETTA
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
29 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton Label
Tikketta tal- Kartuna
Rapinyl and associated names (see Annex I) 50 microgram sublingual tablets [See Annex I - To be completed nationally] Rapinyl 100 microgram sublingual tablets Rapinyl 200 microgram sublingual tablets Rapinyl 300 microgram sublingual tablets Rapinyl 400 microgram sublingual tablets Rapinyl 600 microgram sublingual tablets Rapinyl 800 microgram sublingual tablets
Rapinyl u ismijiet assoċjati (ara Anness I) 50 mikrogramma pilloli għal taħt l- ilsien [Ara Anness I - Biex jitlesta fil- pajjiż partikolari] Rapinyl 100 mikrogramma pilloli għal taħt l- ilsien Rapinyl 200 mikrogramma pilloli għal taħt l- ilsien Rapinyl 300 mikrogramma pilloli għal taħt l- ilsien Rapinyl 400 mikrogramma pilloli għal taħt l- ilsien Rapinyl 600 mikrogramma pilloli għal taħt l- ilsien Rapinyl 800 mikrogramma pilloli għal taħt l- ilsien
Each sublingual tablet contains 50 micrograms fentanyl (as citrate) 100 micrograms fentanyl (as citrate) 200 micrograms fentanyl (as citrate) 300 micrograms fentanyl (as citrate) 400 micrograms fentanyl (as citrate) 600 micrograms fentanyl (as citrate) 800 micrograms fentanyl (as citrate)
Kull pillola għal taħt l- ilsien fiha 50 mikrogramma fentanyl (bħala citrate) 100 mikrogramma fentanyl (bħala citrate) 200 mikrogramma fentanyl (bħala citrate) 300 mikrogramma fentanyl (bħala citrate) 400 mikrogramma fentanyl (bħala citrate) 600 mikrogramma fentanyl (bħala citrate) 800 mikrogramma fentanyl (bħala citrate)
10 tablets 30 tablets
10 pilloli 30 pillola
To be dissolved under the tongue.
Użu għal taħt l- ilsien Sabiex tinħall taħt l- ilsien.
Do not swallow Read the package leaflet before use.
Tiblax Aqra l- fuljett ta ’ tagħrif qabel l- użu.
This product should ONLY be used as prescribed.
Dan il- prodott għandu jintuża BISS kif preskritt.
If the product is used by anyone else it could represent a SERIOUS risk to their health
Jekk il- prodott jintuża minn xi ħadd ieħor jista ’ jkun hemm riskju SERJU għas- saħħa tagħhom
Store in the original blister package in order to protect from moisture
Aħżen fil- pakkett ta ’ folji oriġinali sabiex tilqa ’ mill- umdità.
It is recommended to keep Rapinyl in a locked storage space
Huwa rakkomandat li Rapinyl jinżamm f’ post li jingħalaq
Unused product should be taken, if possible, to your pharmacist.
Prodott mhux użat għandu jittieħed, jekk possibbli, lill- ispiżjar tiegħek.
[See Annex I - To be completed nationally]
[Ara Anness I - Biex jitlesta fil- pajjiż partikolari]
{Name and address }< {tel }> < {fax }> < {e-mail }>
{Isem u indirizz} < {tel} > < {faks} > < {posta elettronika} >
[To be completed nationally]
[Biex jitlesta fil- pajjiż partikolari]
29 [To be completed nationally]
[Biex jitlesta fil- pajjiż partikolari]
Rapinyl 50 micrograms Rapinyl 100 micrograms Rapinyl 200 micrograms Rapinyl 300 micrograms Rapinyl 400 micrograms Rapinyl 600 micrograms Rapinyl 800 micrograms
Rapinyl 50 mikrogramma Rapinyl 100 mikrogramma Rapinyl 200 mikrogramma Rapinyl 300 mikrogramma Rapinyl 400 mikrogramma Rapinyl 600 mikrogramma Rapinyl 800 mikrogramma
30 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
32 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Rapinyl and associated names (see Annex I) 50 µg sublingual tablets [See Annex I - To be completed nationally] Rapinyl 100 µg sublingual tablets Rapinyl 200 µg sublingual tablets Rapinyl 300 µg sublingual tablets Rapinyl 400 µg sublingual tablets Rapinyl 600 µg sublingual tablets Rapinyl 800 µg sublingual tablets
Rapinyl u ismijiet assoċjati (ara Anness I) 50 µg pilloli għal taħt l- ilsien [Ara Anness I - Biex jitlesta fil- pajjiż partikolari] Rapinyl 100 µg pilloli għal taħt l- ilsien Rapinyl 200 µg pilloli għal taħt l- ilsien Rapinyl 300 µg pilloli għal taħt l- ilsien Rapinyl 400 µg pilloli għal taħt l- ilsien Rapinyl 600 µg pilloli għal taħt l- ilsien Rapinyl 800 µg pilloli għal taħt l- ilsien
31 PACKAGE LEAFLET
33 FULJETT TA ’ TAGĦRIF
32 PACKAGE LEAFLET:
34 FULJETT TA ’ TAGĦRIF:
Rapinyl and associated names (see Annex I) 50 microgram sublingual tablets [See Annex I - To be completed nationally] Rapinyl 100 microgram sublingual tablets Rapinyl 200 microgram sublingual tablets Rapinyl 300 microgram sublingual tablets Rapinyl 400 microgram sublingual tablets Rapinyl 600 microgram sublingual tablets Rapinyl 800 microgram sublingual tablets
Rapinyl u ismijiet assoċjati (ara Anness I) 50 mikrogramma pilloli għal taħt l- ilsien [Ara Anness I - Biex jitlesta fil- pajjiż partikolari] Rapinyl 100 mikrogramma pilloli għal taħt l- ilsien Rapinyl 200 mikrogramma pilloli għal taħt l- ilsien Rapinyl 300 mikrogramma pilloli għal taħt l- ilsien Rapinyl 400 mikrogramma pilloli għal taħt l- ilsien Rapinyl 600 mikrogramma pilloli għal taħt l- ilsien Rapinyl 800 mikrogramma pilloli għal taħt l- ilsien Fentanyl
What Rapinyl is and what it is used for 2.
X’ inhu Rapinyl u għalxiex jintuża 2.
Before you take Rapinyl 3.
Qabel ma tieħu Rapinyl 3.
How to take Rapinyl 4.
Kif għandek tieħu Rapinyl 4.
How to store Rapinyl 6.
Kif taħżen Rapinyl 6.
WHAT RAPINYL IS AND WHAT IT IS USED FOR
X’ INHU RAPINYL U GĦALXIEX JINTUŻA
Rapinyl is a treatment for people who must already regularly be taking strong pain-relieving medicine (opioids) for their persistent cancer pain, but require treatment for their breakthrough pain.
Rapinyl hu trattament għl persuni li diġà qed jieħdu mediċina qawwija b’ mod regolari biex iserraħhom mill- uġigħ (opjojdi) għall- uġigħ persistenti tagħhom mill- kanċer, imma jinħtieġu trattament għall- uġigħ sfondat tagħhom.
If you are not sure, talk to your doctor.
Jekk m’ intix żgur, staqsi lit- tabib tiegħek.
Breakthrough pain is pain which occurs suddenly, even though you have taken or used your usual opioid pain-relieving medicine.
L- uġigħ sfondat hu uġigħ li jseħħ f’ daqqa, anke jekk tkun ħadt jew użajt l- mediċina opjojdi li s- soltu sserħek.
The active substance in Rapinyl sublingual tablets is fentanyl.
Is- sustanza attiva fil- pilloli Rapinyl għal taħt l- ilsien hi fentanyl.
Fentanyl belongs to a group of strong pain-relieving medicines called opioids.
Fentanyl jappartjeni hħal grupp ta ’ mediċini qawwija li jserrħu mill- uġigħ msejħa opjojdi.
BEFORE YOU TAKE RAPINYL
QABEL MA TIEĦU RAPINYL
• if you are allergic (hypersensitive) to fentanyl or any of the other ingredients of Rapinyl • if you have severe breathing problems
Tieħux Rapinyl • jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal fentanyl jew sustanzi oħra ta ’ Rapinyl • jekk għandek probelmi severi biex tieħu n- nifs
Before you start treatment with Rapinyl, you must have been regularly taking or using a prescribed strong pain-relieving medicine, called an opioid, to control your persistent pain.
Qabel ma tibda t- trattament b’ Rapinyl, inti regolarment kont qed tieħu jew qed tuża mediċna qawwija li tingħata b’ riċetta għas- serħan ta ’ l- uġigħ, li tissejjaħ opjojdi, sabiex tikkontrolla l- uġigħ persistenti.
If you have not, this medicine could cause severe breathing difficulties (see section 4 – Possible side effects).
Jekk le, din il- mediċina tista ’ tikkaġuna diffikultajiet severi fit- teħid tan- nifs (ara sezzjoni 4 – Effetti sekondarji li jista ’ jkollu).
If you are not sure, talk to your doctor.
Jekk m’ intix żgur, kellem lit- tabib tiegħek.
33 Take special care with Rapinyl
Oqgħod attent ħafna b’ Rapinyl
Tell your doctor before treatment if you have or have recently had any of the following, as your doctor will need to take account of these when prescribing your dose: • a head injury, because Rapinyl may cover up the extent of the injury • breathing problems or suffer from myasthenia gravis (a condition characterised by muscle weakness) • a slow heart rate or low blood pressure • liver or kidney disease, as this may require your doctor to more carefully adjust your dose • a brain tumour and/ or raised intracranial pressure (an increase of pressure in the brain which causes severe headache, a feeling of sickness and blurred vision) • mouth wounds or mucositis (swelling and redness of the inside of the mouth)
35 Għarraf lit- tabib tiegħek qabel it- trattament jekk għandek jew riċentement kellek xi wieħed minn dawn li ġejjin, peress li t- tabib tiegħek għandu mnejn ikollu bżonn jikkonsidra dawn meta jippreskrivi d- doża tiegħek: • ferita fir- ras peress li Rapinyl jista ’ jkopri l- firxa tal- ferita • problemi bit- teħid tan- nifs jew tbati minn majastenja gravis (kundizzjoni li hi karatterizzata minn debolezza muskolari) • rata baxxa ta ’ taħbit tal- qalb jew pressjoni tad- demm baxxa • mard tal- fwied jew tal- kliewi, peress li dan għandu mnejn ikun jeħtieġ li t- tabib tiegħek jaġġusta b’ reqqa akbar id- doża tiegħek • tumur tal- moħħ u/ jew pressjoni intrakranjali mgħollija (żieda fil- pressjoni tal- moħħ li tikkawża uġigħ ta ’ ras qawwi, tħossik ma tiflaħx u vista mċajpra) • leżjonijiet fil- ħalq jew mukosite (nefħa u ħmura fuq in- naħa ta ’ ġewwa tal- ħalq)
When taking Rapinyl, if you are to have any surgery, inform your doctor or dentist that you are taking this medicine.
Jekk ikun ser ikollok xi intervent kirurġiku u qed tieħu Rapinyl, għarraf lit- tabib jew dentist tiegħek li qed tieħu din il- mediċina.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines (other than your regular opioid pain-relieving medicine), including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra (għajr il- mediċina opjojdi regolari li sserħek mill- uġigħ), anki dawk mingħajr riċetta.