qanastek/EMEA-V3 huggingface dataset:
76 PACKAGE LEAFLET
76 FULJETT TA ’ TAGĦRIF
What Fentanyl-ratiopharm is and what it is used for 2.
X’ inhu Fentanyl- ratiopharm u għalxiex jintuża 2.
Before you use Fentanyl-ratiopharm 3.
Qabel ma tuża Fentanyl- ratiopharm 3.
How to use Fentanyl-ratiopharm 4.
Kif għandek tuża Fentanyl- ratiopharm 4.
How to store Fentanyl-ratiopharm 6.
Kif taħżen Fentanyl- ratiopharm 6.
WHAT FENTANYL-RATIOPHARM IS AND WHAT IT IS USED FOR
X’ INHU FENTANYL- RATIOPHARM U GĦALXIEX JINTUŻA
Fentanyl is one of a group of strong painkillers called opioids.
Fentanyl jappartjeni għall- grupp ta ’ analġesiċi qawwijin li jissejħu opjojdi.
The painkiller, fentanyl, slowly passes from the patch, through the skin and into the body.
L- analġesiku, fentanyl, jgħaddi bil- mod mill- garża, minn ġol- ġilda u għal ġol- ġisem.
Fentanyl-ratiopharm is used for treatment of severe and long-lasting pain that can only adequately be managed with strong pain relievers.
Fentanyl- ratiopharm jintuża għall- kura ta ’ uġigħ qawwi w dewmieni li jista ’ jiġi mmaneġġjat adegwatament biss permezz ta ’ analġesiċi qawwijin
BEFORE YOU USE FENTANYL-RATIOPHARM
QABEL MA TUŻA FENTANYL- RATIOPHARM
Do not use Fentanyl-ratiopharm
Tużax Fentanyl- ratiopharm
- if you are hypersensitive (allergic) to fentanyl or any of the other ingredients of the product.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal fentanyl jew sustanzi oħra tal- prodott
- if you suffer from pain which lasts only for a short period, e. g. after a surgical procedure.
- jekk tbati minn uġigħ illi ma ’ jdumx fit- tul, eż. wara proċedura kirurġica.
- if your central nervous system is severely impaired, for instance by brain injury.
- jekk is- sistema nervuża ċentrali tiegħek hija dgħajfa ħafna bħal, per eżempju, wara ferita fil -
Take special care with Fentanyl-ratiopharm
Oqgħod attent ħafna b ’ Fentanyl- ratiopharm:
Fentanyl-ratiopharm is a medicinal product that could be life-threatening to children.
Fentanyl- ratiopharm huwa prodott mediċinali li jista ’ jkun ta ’ theddida għall- ħajja fit- tfal.
This is also the case with used transdermal patches.
Dan japplika wkoll għal garża transdermali użata.
Bear in mind that the design of this medicinal product could be tempting to a child.
Dejjem żomm f’ moħħok illi l- għamla tal- prodott tista ’ tidher attrajenti fl- għajnejn tat- tfal.
Fentanyl-ratiopharm can have life-threatening side-effects in persons that are not using prescribed opioid medicines on a regular basis.
Fentanyl- ratiopharm jista ’ jkollu effetti mhux mixtieqa ta ’ theddida għall- ħajja f’ persuni li mhux qed jieħdu mediċini tat- tip opjojdi fuq bażi regolari.
Before starting to use Fentanyl-ratiopharm you should inform your doctor if you suffer from any of the below disorders, because the risk of side effects is higher and/ or your doctor may need to prescribe a lower dose of fentanyl.
Qabel tibda l- kura b’ Fentanyl- ratiopharm għandek tgħarraf lit- tabib tiegħek jekk tbati minn kundizzjonijiet imsemmijin hawn taħt, peress li r- riskju ta ’ effetti mhux mixtieqa huwa ogħla u għaldaqstant it- tabib jista ’ jiktiblek doża inqas ta ’ fentanyl.
- asthma, respiratory depression or any lung disease
- ażma, dipressjoni respiratorja jew xi mard fil- pulmun
- low blood pressure
- pressjoni baxxa
- impaired liver function
- indeboliment tal- fwied
- impaired kidney function
- indeboliment tal- kliewi
- if you have had a head injury, a brain tumour, signs of increased intracranial pressure (e. g.
- jekk kellek xi ferita f’ rasek, tumur ġo moħħok, sinjali ta ’ żieda tal- pressjoni ġol- kranju
headache, visual disturbances), changes in your state of consciousness or loss of consciousness or coma
(eż. uġigħ ta ’ ras, tibdil fil- vista), tibdil fl- isstat konxju jew tintilef minn sensik jew koma
- slow irregular heartbeat (bradyarrhythmias)
- rata baxxa u irregolari tat- taħbit tal- qalb (bradiarritmija)
- myasthenia gravis (a disease causing tiredness and weakness of the muscles)
- Majastenja gravis (marda li tikkawza għejja u indeboliment fil- muskoli)
Inform your doctor if you develop a fever during the treatment, as the increased body temperature may cause too much medicine to pass through the skin.
Għarraf lit- tabib tiegħek jekk jaqbdek id- deni waqt il- kura, għax żieda fit- temperatura tal- ġisem tista ’ twassal għal assorbiment żejjed tal- mediċina minn ġol- ġilda.
For the same reason you should avoid exposing the patch on the skin to direct heat such as electric blankets, hot-water bottles, sauna, solarium or hot baths.
Għall- istess raġuni, għandek tevita li tesponi l- garza mwaħħla fuq il- ġilda għal sorsi ta ’ sħana esterna bħal kutri tal- elettriku, hot water bottles, sawna, solarium jew banju sħun.
It is allowed to stay outside in the sun, but you must protect the patch with some piece of clothing during hot summer days.
Tista ’ toqgħod barra fix- xemx, iżda trid tgħatti l- garża b’ xi ħwejjeġ fil- ġranet sħan tas- sajf.
Tolerance, physical or psychological dependence may develop if you use Fentanyl-ratiopharm for a longer period.
Tolleranza, kif ukoll dipendenza fiżika jew psikoloġika, tista ’ tirriżulta jekk tuża l- Fentanyl - ratiopharm għal medda twila ta ’ żmien.
However, this is rarely seen during treatment of pain due to cancer.
Madankollu, dawn rarament li jseħħu waqt il- kura tal- uġigħ tal- kanċer.
If you are an elderly patient or if you are in a very bad physical condition (cachectic) your doctor will monitor you more carefully, because it may be necessary to prescribe a lower dose.
Jekk inti pazjent anzjan, jew jekk tinstab f’ kundizzjoni fisika ħażina ħafna (kakesiku), it- tabib tiegħek ser josservak b’ iktar attenzjoni, għax jista ’ jkun hemm il- bżonn li d- doża preskritta tiġi mnaqqsa.
The patches should not be cut into smaller parts, because the quality, efficacy and safety of such divided patches have not been demonstrated.
Il- garża m’ għandiex tinqasam f’ biċċiet iżgħar, għax m’ hemmx informazzjoni disponibbli fuq il- kwalita ’, l- effikaċja u s- sigurta ’ ta ’ garża hekk masqsuma.
Children Fentanyl-ratiopharm should not be administered to children under 12 years of age because there is limited experience of use in children.
Tfal Fentanyl- ratiopharm m’ għandux jintuża fit- tfal taħt it- 12- il sengħa għaliex it- tagħrif disponibbli dwar l- użu fit- tfal huwa limitat.
An exception can be made if the doctor has expressly prescribed Fentanyl-ratiopharm.
Tista ’ ssir eċċezzjoni meta t- tabib ikun ippreskriva espressivament Fentanyl- ratiopharm.
Using other medicines Please tell your doctor if you use barbiturates (used for treating sleep disorders), buprenorphine, nalbuphine or pentazocine (other strong painkillers).
Jekk jogħġbok għid lit- tabib tiegħek jekk qed tieħu barbiturates (jintużaw għal problemi ta ’ rqad), buprenorphine, nalbuphine jew pentazocine (analġesiċi qawwijin oħrajn).
It is not recommended to use those together with Fentanyl-ratiopharm.
Mhux irrakkommandat li dawn jittieħdu waqt l- użu ta ’ Fentanyl- ratiopharm
If you take concomitantly medicines that affect brain function it is more likely that you’ ll have side effects especially difficulty in breathing.
Jekk qed tuża, fl- istess ħin, mediċini oħrajn li jistgħu jaffetwaw il- funzjoni tal- moħħ, ir- riskju ta ’ effetti sekondarji, speċjalment id- diffikultà biex tieħu n- nifs, jiżdied.
This applies, for example, to:
Per eżempju, dan japplika għal:
- medicines used for treating anxiety (tranquillisers)
- mediċini li jtaffu l- ansjeta ’ (kalmanti)
- medicines used for treating depression (antidepressants)
- mediċini għal kura tad- dipressjoni (antidipressivi)
- medicines used for treating psychological disorders (neuroleptics)
- mediċini għal kura ta ’ disturbi psikologiċi (newroleptiċi)
- anaesthetics, if you think you are going to have an anaesthetic, tell the doctor or dentist that you
- anestetiċi, jekk taħseb li ser tieħu anestetiku, għarraf lit- tabib jew id- dentist illi qed tuża
are using Fentanyl-ratiopharm
Fentanyl- ratiopharm
- medicines used for treating sleep disorders (hypnotics, sedatives)
- mediċini għal kura ta ’ disturbi tal- irqad (ipnotiċi, aġenti sedattivi, barbiturates)
- medicines used for treating allergies or travel sickness (antihistamines/ antiemetics)
- mediċini kontra l- allerġiji jew id- dardir tas- safar (Antiħistaminiċi/ anti- emetiċi)
- other strong-acting painkillers (opioids)
- analġesiċi qawwijin oħrajn (opjojdi)
- alcohol
- l- alkoħol
You should not take the medicines listed below at the same time as you are using Fentanyl- ratiopharm, unless you are closely monitored by your doctor.
M’ għandekx tuża l- mediċini li ġejjin flimkien ma ’ Fentanyl- ratiopharm, sakemm ma ’ tkunx osservat mill- viċin mit- tabib tiegħek.
These medicines may increase the effects and side effects of Fentanyl-ratiopharm.
Dawn il- mediċini jistgħu iżidu l- effetti kif ukoll l- effetti sekondarji ta’ Fentanyl- ratiopharm.
This applies, for example, to:
Dan japplika għal, per eżempju:
- ritonavir (used to treat AIDS)
- ritonavir (użat fil- kura tal- marda t’ AIDS)
- ketoconazole, itraconazole (used to treat fungal diseases)
- ketoconazole, itraconazole (użati għall- kura ta ’ infezzjonijiet tal- fungu)
- diltiazem (used to treat heart disease)
- diltiazem (użat għall- kura ta ’ mard fil- qalb)
- cimetidine (used to treat gastrointestinal diseases)
- cimetidine (użat għall- kura ta ’ mard gastro- intestinali)
- macrolide antibiotics (used to treat infections)
- antibiotiċi makrolidi (użati għall- kura ta ’ infezzjonijiet)
79 Please tell your doctor if you are taking MAO inhibitors (e. g. moclobemide against depression or selegiline against Parkinson’ s disease) or have taken them within the last 14 days.
Moclobemide, jintuża kontra d- dipressjoni, jew selegiline, jintuża fil- kura tal- marda ta ’ Parkinson) jew jekk tkun ħadthom fl- aħħar ġimgħatejn.
If these medicines are taken together this may enhance their toxicity.
Jekk dawn il- mediċini jittieħdu flimkien, tista ’ tiżdied it- tossiċita ’ tagħhom.
Using Fentanyl-ratiopharm with food and drink Simultaneous use of Fentanyl-ratiopharm and alcoholic beverages increases the risk of severe adverse reactions, and may cause breathing difficulties, a fall of blood pressure, profound sedation and coma.
L- użu fl- istess ħin ta ’ Fentanyl- ratiopharm u x- xorb alkoħoliku jżid ir- riskju ta ’ reazzjonijiet avversi severi, u jista ’ jikkawża diffikultà fin- nifs, tnaqqis fil- pressjoni tad- demm, sedazzjoni profonda u koma.
Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
It is advised not to use Fentanyl-ratiopharm during labour and delivery (including caesarean section) because fentanyl may cause breathing problems in the newborn child.
L- użu ta ’ Fentanyl- ratiopharm waqt it- tqala u il- ħlas (anki ħlas ċesarju) mhux rakkommandat, peress li fentanyl jista ’ jikkawza problemi tan- nifs fit- tarbija tat- twelid.
If you get pregnant during treatment with Fentanyl-ratiopharm, consult your doctor.
Jekk toħroġ tqila waqt kura bil- Fentanyl- ratiopharm, fittex il- parir tat- tabib tiegħek.
Fentanyl-ratiopharm should not be used during pregnancy and breast-feeding unless clearly necessary.
Fentanyl- ratiopharm m’ għandux jintuża waqt it- tqala u r- treddiegħ ħlief meta jkun hemm bżonn ċar.
Safe use during pregnancy has not been established.
Is- sigurta ’ waqt it- tqala għada ma gietx stabbilita.
Fentanyl passes into the breast-milk and may cause side effects in the breast-fed infant as sedation and respiratory depression.
Fentanyl joħroġ fil- ħalib tas- sider u għaldastant jista ’ jkollu effetti sedattivi u jikkawza dipressjoni respiratorja fit- trabi li għadhom qed jerdgħu.
Any breast milk produced during treatment or within 72 hours after the removal of the last patch should be discarded.
Il - ħalib tas- sider li tipproduċi l- omm waqt il- kura, jew sa 72 siegħa wara li titneħħa l- aħħar garża, għandu jintrema.
Driving and using machines Fentanyl-ratiopharm has major influence on the ability to drive and use machines.
Fentanyl- ratiopharm għandu effett qawwi ħafna fuq il- ħila tas- 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 ikun iktar mistenni fil- bidu tal- kura, meta tinbidel id- doża, kif ukoll meta jintuża flimkien mal- alkoħol jew aġenti sedattivi.
If you have been using the same dose of Fentanyl-ratiopharm for a longer period of time, your doctor may decide that you are permitted to drive and use dangerous machines.
Jeqq kont qed tuża l- istess doża ta ’ Fentanyl- ratiopharm għal zmien twil, it- tabib tiegħek jista ’ jtik permess biex issuq jew tħaddem magni perikolużi.
Do not drive or operate dangerous machines while using Fentanyl-ratiopharm, unless your doctor has told you that such is permitted.
M’ għandekx issuq jew tħaddem magni perikolużi waqt l- użu ta ’ Fentanyl- ratiopharm, sakemm it- tabib tiegħek ma jgħidlekx speċifikament illi dan huwa permess.
HOW TO USE Fentanyl-ratiopharm
KIF GĦANDEK TUŻA FENTANYL- RATIOPHARM
Always use Fentanyl-ratiopharm exactly as your doctor has told you.
Dejjem uża Fentanyl- ratiopharm eżattament kif ikun qallek it- tabib.
Your doctor will decide which strength of Fentanyl-ratiopharm is most suitable for you.
It- tabib tiegħek jiddeċidi liema doża ta ’ Fentanyl- ratiopharm hi l- iktar addatata għalik.
Your doctor will base his judgement on: the severity of your pain, your general condition and the type of pain treatment that you have received so far.
It- tabib tiegħek jibbaża d- deċiżjoni tiegħu fuq: kemm qed tħoss uġigħ, il- kundizzjoni ġenerali tiegħek u it- tip ta ’ kura għall- uġigħ li tkun irċevejt s’ issa.
According to your reaction the strength of the patch or the number of patches may need to be adjusted.
Skond ir- rispons tiegħek, jista ’ jkun hemm bżonn illi d- doża tal- garża jew in- numru tagħhom jiġumibdula.
The effect is reached within 24 hours after the first patch has been applied and its effects fall gradually after the patch is removed.
L- effett analġesiku massimu jintlaħaq sa 24 siegħa wara li tkun ingħatat l- ewwel garża u jiddgħajjef gradwalment wara li din titneħħa.
Do not discontinue treatment without consulting your doctor.
Twaqqafx il- kura qabel ma tfittex il- parir tat- tabib tiegħek
Your first patch will start to work slowly, this may take as long as one day, so your doctor may give you extra painkillers until your fentanyl transdermal patch starts working completely.
L- ewwel garza tibda taħdem bil- mod, u l- effett jista ’ jdum biex jinħass anki ġurnata, u għaldaqstant it- tabib tiegħek jista ’ jippreskrivilek analġesiċi oħrajn, sakemm l- effett tal- Fentanyl- ratiopharm jibda jinħass kif meħtieġ.
After this, the Fentanyl-ratiopharm should help to relieve pain continuously and you should be able to stop taking these extra painkillers.
Wara, il - Fentanyl- ratiopharm għandu jgħin biex itaffi l- uġigħ kontinwament u jista ’ jkun possibli li tieqaf tieħu dawn l- analġesiċi żejda.
However sometimes you may still need extra painkillers.
Madankollu, xorta waħda jista ’ jkollok bżonn ta ’ analġesiċi miżjuda kull tant żmien..
80
80 Kif tapplika l- Fentanyl- ratiopharm
- If the skin is hairy, then cut the hair with scissors.
- Jekk il- ġilda għandha l- pil, neħħieh bl- użu ta ’ mqass.
If
Tqaxxarx, għax it- tqaxxir jirrita il- ġilda.
the skin needs washing, wash with water.
Jekk il- ġilda għandha bżonn tiġi maħsula, inħasel bl- ilma.
Do not use soap, oil, lotions, alcohol or other cleansers that may irritate the skin.
Tużax sapun, żejt, fwejjaħ, alkoħol, jew xi likwidu għall- ħasil tal- ġisem iehor li jista ’ jirrita l- ġilda.
The skin must be completely dry before applying the patch.
Il- ġilda trid tkun kompletament niexfa qabel ma ’ titwaħħal il- garża.
- The patch must be stuck on immediately after opening the package.
- Il- garża trid titwaħħal immedjatament wara li l- pakkett jinfetaħ.
When the release liner has
Wara li jitneħħa r- release liner,
been removed, the patch is applied by pressing it firmly onto the skin with the palm of the hand for approximately 30 seconds to make sure that the patch sticks well to the skin.
il- garża tiġi applikata fuq il- ġilda permezz ta ’ pressjoni ħafifa bil- pala tal- id għal madwar 30 sekonda sabiex ikun assigurat li l- garża teħel sewwa mal- ġilda.
Pay special attention to see that the patch sticks properly at the edges.
Oqgħod attent li l- ġnub tal- garża jeħlu sewwa.
- A fentanyl transdermal patch is usually used for 72 hours (3 days).
- Garża ta ’ Fentanyl- ratiopharm is- soltu tintuża għal 72 siegħa (3 ijiem).
On the outer package you
Tista ’ tniżżel id- data u
can write the date and time you applied the patch.
il- ħin ta ’ meta applikajt il- garża fuq il- kaxxa ta ’ barra.
This may help you remember when to change your patch.
Dan jista ’ jgħinek biex tiftakar meta l- garża għandha tinbidel.
- The patch application site should not be exposed to heat from external heat sources (see “ Take
- Il- post fejn titwaħħal il- garża ma ’ jridx ikun espost għas- sħana li ġejja minn sorsi esterni (ara
special care with Fentanyl-ratiopharm”).
“ Oqgħod attent ħafna bil- Fentanyl- ratiopharm ”)
- As the transdermal patch is protected by an outer waterproof backing film, it can also be worn
- Peress li l- garża transdermali hija protetta b’ film estern fuq in- naħa ta ’ wara li jiflaħ għall- ilma,
while showering.
tista ’ tintlibes wkoll waqt id- doċċa.
- In children, the upper back is the preferred location to apply the patch, to minimize the potential
- Fit- tfal, in- naħa ta ’ fuq tad- dar huwa il- post preferibbli fejn titwaħħal il- garża, biex b’ hekk
of the child removing the patch.
jitnaqqas ir- riskju li it- tifel/ tifla i/ tneħħi l- garża.
How to change the transdermal patch
Kif tibdel il- garża transdermali
- Remove the patch after the period your doctor has told you.
- Neħħi l- garża wara l- perijodu li jkun speċifikalek it- tabib.
In most cases this is after 72 hours
Fl- aktar każi, dan huwa wara 72
(3 days), in some patients after 48 hours (2 days).
siegħa (3 ijiem), f’ xi pazjenti wara 48 siegħa (2 ijiem).
Usually the patch does not come off by itself.
Is- soltu, il- garża ma ’ tinqalax waħedha.
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.
- Fold the used patch in half so that the sticky edges adhere to each other.
- Itwi l- garża wżata b’ mod illi l- ġnub li jwaħħlu jeħlu ma ’ xulxin.
Put back used patches
Poġġi l- garża wżata lura fil -
in the outer package and discard or whenever possible hand in to your pharmacist.
pakkett ta ’ barra u armiha, jew, jekk ikun possibli, ħudha lura għand l- ispiżjar.
- Apply a new patch as described above but on another part of the skin.
- Applika garża ġdida kif spjegat qabel iżda fuq parti oħra tal- ġilda.
At least 7 days should
Mill- inqas 7 ijiem iridu jkunu
elapse before the same part is used again.
għaddew qabel ma ’ tkun tista ’ tintuża l- istess parti tal- ġisem.
If you use more Fentanyl-ratiopharm than you should If you have stuck on more patches than prescribed, remove the patches and contact your doctor or hospital on their opinion of the risk.
Jekk waħħalt numru ta ’ garżi iktar milli suppost, neħħihom u fittex il- parir tat- tabib tiegħek jew ċempel l- isptar biex tara x’ inhu r- riskju.
The most common sign of overdose is reduced ability to breathe.
Is- sinjal l- aktar komuni ta ’ doża eċċessiva huwa abilita ’ mnaqqsa biex tieħu n- nifs.
Symptoms are that the person breathes abnormally slowly or weakly.
Is- sintomi huma t- teħid tan- nifs ikun bil- mod ħafna jew in- nifs ikun dgħajjef.
If this should occur – remove the patches and contact a doctor immediately.
Jekk dan iseħħ, neħħi il- garża u kkuntattja t- tabib minnufiħ.
While waiting for the doctor, keep the person awake by talking to or shaking her/ him now and then.
Waqt li qed tistenna l- wasla tat- tabib, żomm il- pażjent imqajjem billi tkellmu jew iċċaqalqu minn ħin għall- iehor.
Other signs and symptoms of overdose are drowsiness, low body temperature, slow heart rate, decreased muscle tone, deep sedation, loss of muscle co-ordination, constriction of the pupils and convulsions.
Sinjali u sintomi oħrajn ta ’ doża eċċessiva huma ħedla, temperatura baxxa, rata baxxa tat- taħbit tal- qalb, tnaqqis fit- ton tal- muskoli, sedazjoni profonda, telf ta ’ koordinazzjoni fil- muskoli, djuq fil- pupilla tal- għajnejn u konvulżjonijiet.
If you forget to use Fentanyl-ratiopharm Do not under any circumstances use a double dose.
Taħt l- ebda ċirkostanzi ma trid tieħu doża doppja biex tpatti għal xi doża li tkun insejt tieħu.
You should change your patch at the same time of day every three days (every 72 hours), unless directed otherwise by your doctor.
Għandek tbiddel il- garża darba kull tlett ijiem (kull 72 siegħa) fl- istess ħin, sakemm it- tabib tiegħek ma ’ jgħidlekx mod ieħor.
If you forget, then change your patch as soon as you remember.
Jekk tinsa ’, biddel il- garża fil- mument li tiftakar.
If you are very late changing your patch then you should contact your doctor because you might need some extra painkillers.
Jekk tkun bdilt il- garża tard ħafna, tkellem mat- tabib tiegħek għax jista ’ jkollok bżonn ta ’ xi analġesiċi oħrajn.
If you stop using Fentanyl-ratiopharm If you wish to interrupt or stop the treatment, you should always talk to your doctor about the reasons for discontinuation and your continued treatment.
81 Jekk tixtieq tinterrompi jew twaqqaf il- kura, dejjem għandek tgħarraf lit- tabib tiegħek dwar ir- raġunijiet għaliex trid tieqaf mill- kura u ħu parir dwar il- kura sussegwenti tiegħek.
Prolonged use of Fentanyl-ratiopharm can cause physical dependence.
L- użu fit- tul ta ’ Fentanyl- ratiopharm jista ’ jirriżulta f’ dipendenza fiżika.
If you do stop using the patches you may feel unwell.
Jekk tieqaf tuża l- garża, jista ’ ma tħossokx sewwa.
As the risk of withdrawal symptoms is greater when the treatment is stopped suddenly, you should never stop treatment with Fentanyl-ratiopharm independently but always consult your doctor first.
Peress li r- riskju tal- effetti assoċjati mal- waqfien mill- kura huwa ikbar meta tiġi mwaqqfa ħesrem, qatt m’ għandek tieqaf mill- kura minn jeddek, imma għandek dejjem l- ewwel tfittex il- parir tat- tabib tiegħek
Like all medicines, Fentanyl-ratiopharm can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Fentanyl- ratiopharm jista ’ jkollu effetti sekondarji, għalkemm jistgħu ma ’ jidhrux f’ kulħadd.
The assessment of side effects is based on the following frequency data:
It- termini li ġejjin jintużaw biex jiddeskrivu kemm il darba ġew irrapurtati l- effetti sekondarji:
less than 1 in 10, but more than 1 in 100 patients less than 1 in 100, but more than 1 in 1000 patients less than 1 in 1000, but more than 1 in 10,000 patients less than 1 in 10,000 patients, including isolated reports
iseħħu f’ iktar minn pazjent minn kull 10 Komuni ħafna iseħħu f’ inqas minn 1 kull 10, iżda f’ iktar minn 1 minn kull Komuni 100 pazjenti iseħħu f’ inqas minn 1 kull 100, iżda f’ iktar minn 1 minn Mhux kull 1, 000 pazjenti komuni iseħħu f’ inqas minn 1 kull 1000, iżda f’ iktar minn 1 minn Rari kull 10000 pazjenti iseħħu f’ inqas minn 1 kull 10000 pazjenti, rapporti iżolati Rari ħafna inklużi
If any of the following serious, very rare side effects occur your should discontinue treatment and immediately contact your doctor or visit a hospital: severe respiratory depression (severe breathlessness, rattling breath) or complete block of the digestion channel (convulsive pain, vomiting, flatulence).
Jekk iġġarrab xi effetti sekondarji minn dawn li ġejjin li huma serji, imma rari ħafna,, minnufiħ għandek twaqqaf il- kura u tmur għand it- tabib tiegħek jew lejn l- isptar: dipressjoni respiratorja qawwija (qtugħ ta ’ nifs qawwi, ħsejjes fin- nifs) jew blukkaġġ kompletament tas- sistema diġestiva (uġigħ konvulsiv, rimettar, uġigħ minħabba gass fl- istonku).
Other side effects Very common:
Komuni ħafna:
Somnolence, headache, dizziness, nausea, vomiting, constipation, sweating, itching.
Ngħas, uġigħ ta ’ ras, sturdament, tqalliegħ, rimettar, stitikezza, żieda fl- għaraq, ħakk.
Itching will usually disappear within one day after the patch has been removed.
Is- soltu, il- ħakk jispiċċa fiżmien ġurnata wara li titneħħa l- garża.
Feeling unusually drowsy or tired (depressant effect on brain function), nervousness, loss of appetite, dry mouth, stomach pain, skin reactions at the attachment site.
Ngħas jew għejja kbira (effett dipressanti fuq il- moħħ), nervożismu, nuqqas ta’ aptit, ħalq xott, uġigħ ta ’ żaqq, reazzjonijiet tal- ġilda fil- post fejn titwaħħal il- garża
Unnatural feeling of happiness, memory loss, difficulties in sleeping, hallucinations, agitation, tremor, sensitivity disturbances, speech disorders, fall or rise in the blood pressure and heart rate, difficulties in breathing, diarrhoea, difficulty in passing urine, skin rash, skin reddening (erythema).
aġitazzjoni, tregħid, disturbi tas- sensi, disturbi fil- kliem u fil- lingwa, inżul jew żieda fil- pressjoni u t- tħabbit tal- qalb, problemi fin- nifs, dijarea, problemi biex tgħaddi l- awrina, raxx, ħmura (eritema).
Skin rash and skin reddening will usually disappear within one day after the patch has been removed.
Is- soltu, ir- raxx u l- ħmura jisparixxu fiżmien ġurnata wara li titneħħa l- garża.
Irregular heartbeat, dilated blood vessels, hiccup, water retention in the tissues, feeling cold.
Tħabbit tal- qalb irregolari, vini u arterji imwessgħin, sulluzzu, akkumulazzjoni ta ’ ilma fil- ġisem, kesħa.
Generalised acute allergic reactions with a fall in the blood pressure and/ or difficulty in breathing (anaphylactic reactions), delusional ideas, states of excitement, loss of physical strength, depression, anxiety, confusion, sexual dysfunction, withdrawal symptoms, coordination disturbances, seizures (including clonic and grand mal seizures), diminished visual acuity, impaired respiration (respiratory depression), respiratory arrest (apnoea), painful bloating, block of the digestion channel, urinary bladder pain, passing water less than normal (reduced urine excretion).
Rejazzjonijiet allerġiċi ġenerali b’ inżul fil- pressjoni tad- demm u/ jew problemi fin- nifs (rejazzjonijiet anafilattiċi), ħsibijiet mhux normali, eċċitament eċċessiv, debbolezza, dipressjoni, ansjeta ’, confużjoni, funzjoni sesswali anormali, sintomi assoċjati mal - waqfien tal- kura, problemi fil- koordinazzjoni, aċċessjonijiet (kemm tat- tip kloniku kif ukoll grand mal), vista mnaqqsa, indeboliment tas- sistema respiratorja (dipressjoni
If you have been will become less develop).
82 respiratorja), waqfien tas- sistema respiratorja (apneja), nefħa fl- istonku bl- uġigħ, blukkaġġ tas- sistema diġestiva, uġigħ fil- bużżieqa tal- awrina, produzzjoni mnaqqsa ta ’ awrina (eskrezzjoni mnaqqsa tal- awrina).
using Fentanyl-ratiopharm for some time, it might happen that Fentanyl-ratiopharm effective for you so that a dose adjustment will be necessary (tolerance may
Jekk ilek tuża l- Fentanyl- ratiopharm għal żmien twil, jita ’ jagħti l- każ li l- effett tiegħu jibda ’ jinħass inqas, tant illi d- doża trid tiġi rranġata (jista ’ tkun żviluppata reżistenza).
Physical dependence may develop as well and you might experience withdrawal symptoms, if you do suddenly stop using the patches.
Tista ’ tiżviluppa dipendenza fiżika wkoll u tista ’ tbati minn sintomi assoċjati mal- waqfien tal- kura jekk tieqaf ħesrem mill- kura tiegħek.
Withdrawal symptoms may be nausea, vomiting, diarrhoea, anxiety and shivering.
Dawn is- sintomi jinkludu tqalliegħ, rimettar, dijarea, ansjeta ’ u tregħid.
HOW TO STORE Fentanyl-ratiopharm
KIF TAĦŻEN FENTANYL- RATIOPHARM
Keep out of the reach and sight of children, even after use.
Żomm il- mediċina fejn ma tintlaħaqx u ma tidhirx mit- tfal, ukoll wara li tispiċċa minnha.
High quantities of the active substance remain in the transdermal patches even after use.
Kwantitajiet kbar tas- sustanza attiva jibqgħu fil- garża transdermali wkoll wara li tkun spiċċajt mill- użu tagħha.
Do not use Fentanyl-ratiopharm after the expiry date which is stated on the package.
Tużax Fentanyl- ratiopharm wara d- data ta ’ skadenza li tidher fuq il- pakett.
For environmental and safety reasons, used as well as unused and out of date patches must be discarded or returned to the pharmacy for disposal.
Għall- protezzjoni ta ’ l- ambjent u minħabba raġunijiet ta ’ sigurta ’, il- garża wżata kif ukoll dawk mhux użati jew skaduti għandhom jintremew jew jittieħdu lura għand l- ispiżjar.
Used patches should be folded in half with the sticky sides together.
Il- garża wżata trid tiġi mitwija fi tnejn biż- żewġ naħat li jwaħħlu mwaħħlin ma ’ xulxin.
Put back used patches in the outer package and discard or whenever possible hand in to your pharmacist.
Poġġi l- garża wżata lura fil- pakkett ta ’ barra u armiha, jew, meta jkun possibli, ħudha lura għand l- ispiżjar.
What Fentanyl-ratiopharm contains
X’ fih Fentanyl- ratiopharm
- The active substance is fentanyl.
- Is- sustanza attiva hi fentanyl.
Each patch of 7.5 cm2 contains 4.125 mg fentanyl.
Kull garża ta ’ 7. 5 cm2 fiha 4. 125 mg
Adhesive layer:
Saff li jwaħħal:
Polyacrylate adhesive layer Backing film:
Saff li jwaħħal magħmul minn Polyacrylate Fojl warrani:
Polypropylene foil, blue printing ink Release liner:
Fojl magħmul minn Polypropylene, Linka għall- istampar kaħlanija Release liner:
Polyethylene terephthalate foil (siliconised)
Fojl magħmul minn Polyethylene terephthalate (bis- silicone)
What Fentanyl-ratiopharm looks like and contents of the pack Fentanyl-ratiopharm is a transparent, transdermal patch with a sticky back so that it can be stuck onto the skin.
Fentanyl- ratiopharm hija garża trasparenti li tipprovdi mediċina li tgħaddi minn ġol- ġilda bil- parti ta ’ wara li twaħħal biex b’ hekk tkun tista ’ titwaħħal mal- ġilda.
The transdermal patches are equipped with a blue imprint with the strength.
Il- garża transdermali għandha is- qawwa partikolari tagħha stampata b’ linka kaħlanija fuq il- parti ta ’ wara.
Fentanyl-ratiopharm is available in packs of 3, 5, 10 or 20 transdermal patches.
Fentanyl- ratiopharm huwa disponibbli f’ paketti ta ’ 3, 5, 10 jew 20 il- garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda.
{Name and address} {tel} {fax} {e-mail}
{Isem u indirizz} {telefon}
83
83 {fax} {e- mail}
Spain France The Netherlands United Kingdom
Merckle GmbH Ludwig- Merckle- Str.
84 PACKAGE LEAFLET:
84 FULJETT TA ’ TAGĦRIF:
86 Please tell your doctor if you are taking MAO inhibitors (e. g. moclobemide against depression or selegiline against Parkinson’ s disease) or have taken them within the last 14 days.
Moclobemide, jintuża kontra d- dipressjoni, jew selegiline, jintuża fil- kura tal- marda ta ’ Parkinson) jew jekk tkun ħadthom fl- aħħar ġimgħatejn.
87
87 Kif tapplika l- Fentanyl- ratiopharm
If you stop using Fentanyl-ratiopharm If you wish to interrupt or stop the treatment, you should always talk to your doctor about the reasons for discontinuation and your continued treatment.
88 Jekk tixtieq tinterrompi jew twaqqaf il- kura, dejjem għandek tgħarraf lit- tabib tiegħek dwar ir- raġunijiet għaliex trid tieqaf mill- kura u ħu parir dwar il- kura sussegwenti tiegħek.
If you have been will become less develop).
89 respiratorja), waqfien tas- sistema respiratorja (apneja), nefħa fl- istonku bl- uġigħ, blukkaġġ tas- sistema diġestiva, uġigħ fil- bużżieqa tal- awrina, produzzjoni mnaqqsa ta ’ awrina (eskrezzjoni mnaqqsa tal- awrina).
{Name and address} {tel} {fax} {e-mail}
{Isem u indirizz}
90
90 {telefon} {fax} {e- mail}
93 Please tell your doctor if you are taking MAO inhibitors (e. g. moclobemide against depression or selegiline against Parkinson’ s disease) or have taken them within the last 14 days.
Moclobemide, jintuża kontra d- dipressjoni, jew selegiline, jintuża fil- kura tal- marda ta ’ Parkinson) jew jekk tkun ħadthom fl- aħħar ġimgħatejn.
94
94 Kif tapplika l- Fentanyl- ratiopharm
If you stop using Fentanyl-ratiopharm If you wish to interrupt or stop the treatment, you should always talk to your doctor about the reasons for discontinuation and your continued treatment.
95 Jekk tixtieq tinterrompi jew twaqqaf il- kura, dejjem għandek tgħarraf lit- tabib tiegħek dwar ir- raġunijiet għaliex trid tieqaf mill- kura u ħu parir dwar il- kura sussegwenti tiegħek.
If you have been will become less develop).
96 respiratorja), waqfien tas- sistema respiratorja (apneja), nefħa fl- istonku bl- uġigħ, blukkaġġ tas- sistema diġestiva, uġigħ fil- bużżieqa tal- awrina, produzzjoni mnaqqsa ta ’ awrina (eskrezzjoni mnaqqsa tal- awrina).
97
97 {telefon} {fax} {e- mail}
100 Please tell your doctor if you are taking MAO inhibitors (e. g. moclobemide against depression or selegiline against Parkinson’ s disease) or have taken them within the last 14 days.
Moclobemide, jintuża kontra d- dipressjoni, jew selegiline, jintuża fil- kura tal- marda ta ’ Parkinson) jew jekk tkun ħadthom fl- aħħar ġimgħatejn.
101
101 Kif tapplika l- Fentanyl- ratiopharm
If you stop using Fentanyl-ratiopharm If you wish to interrupt or stop the treatment, you should always talk to your doctor about the reasons for discontinuation and your continued treatment.
102 Jekk tixtieq tinterrompi jew twaqqaf il- kura, dejjem għandek tgħarraf lit- tabib tiegħek dwar ir- raġunijiet għaliex trid tieqaf mill- kura u ħu parir dwar il- kura sussegwenti tiegħek.
If you have been will become less develop).
103 respiratorja), waqfien tas- sistema respiratorja (apneja), nefħa fl- istonku bl- uġigħ, blukkaġġ tas- sistema diġestiva, uġigħ fil- bużżieqa tal- awrina, produzzjoni mnaqqsa ta ’ awrina (eskrezzjoni mnaqqsa tal- awrina).
104
104 {telefon} {fax} {e- mail}
London, 23 October 2007 EMEA/ 338591/ 2007
Londra, it- 23 ta 'Ottubru 2007 EMEA/ 331678/ 2007
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Fentanyl-ratiopharm 25/ 50/ 75/ 100 µg/ h Matrixpflaster and associated names
OPINJONI LI SSEGWI L- ARTIKOLU 29( 4) 1 RERERENZA GĦAL Fentanyl- ratiopharm 25/ 50/ 75/ 100 µg/ h Matrixpflaster u assoċjati
International Non-Proprietary Name (INN): fentanyl
L- Isem Internazzjonali mhux Patentat (INN): fentanyl
Fentanyl-ratiopharm 25/ 50/ 75/ 100 µg/ h Matrixpflaster and associated names, is an opioid analgesic which is indicated in severe chronic pain which can be adequately managed only with opioid analgesics.
Fentanyl- ratiopharm 25/ 50/ 75/ 100 µg/ h Matrixpflaster u ismijiet assoċjati, hu analġesiku opioid li hu indikat għal uġigħ kroniku sever li jkun jista 'jiġi ġestit adegwatament biss b' analġesiċi opioid.
Ratiopharm GmbH submitted applications for mutual recognition of Fentanyl-ratiopharm 25/ 50/ 75/ 100 µg/ h Matrixpflaster and associated names, transdermal patch on the basis of the marketing authorisation granted by Germany 04 April 2006.
Ratiopharm GmbH ippreżentat applikazzjonijiet għal għarfien reċiproku għal Fentanyl- ratiopharm 25/ 50/ 75/ 100 µg/ h Matrixpflaster u ismijiet assoċjati, stikka transdermali skond l- awtorizzazzjoni għat - tqegħid fis- suq mogħtija mill- Ġermanja fl- 4 ta 'April ta' l- 2006.
The Mutual Recognition Procedure started on 06 July 2006.
Il- Proċedura ta 'l- Għarfien Reċiproku nbdiet fis- 6 ta' Lulju ta 'l- 2006.
The Reference Member State was Germany and the Concerned Member States were Austria, France, the Netherlands, Spain and the United Kingdom.
L- Istat Membru ta 'Referenza kien il- Ġermanja u l- Istati Membri Konċernati kienu l- Awstrija, Franza, l- Olanda, Spanja u r- Renju Unit.
These Member States were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Dawn l- Istati Membri ma setgħux jaqblu dwar l - Għarfien Reċiproku ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq mogħtija mill- Istat Membru ta' Referenza.
Germany referred the reasons for disagreement to the EMEA on 20 December 2006.
Il - Ġermanja rreferiet ir- raġunijiet għan- nuqqas ta 'qbil lill- EMEA fl- 20 ta' Diċembru ta 'l- 2006.
Significant difference has been identified with regard to the proposed indication, posology and contraindications in the product information and the demonstration of bioequivalence and this was considered to be of serious public health concern.
Ġiet identifikata differenza sinjifikanti fir- rigward ta 'l- indikazzjoni proposta, il- pożoloġija u l - kontraindikazzjonijiet fit- tagħrif dwar il- prodott u t- turija tal- bijoekwivalenza u dan ġie kkunsidrat ta' tħassib għas- saħħa pubblika.
This refers to the extension of the indication to non-cancer patients, the choice of conversion tables, whether contraindication for breastfeeding and for interactions with partial agonist opioids should be given inn the product information and the studies needed to demonstrate bioequivalence with the reference medicinal product.
Dan jirreferi għall- estensjoni ta 'l- indikazzjoni għal pazjenti li ma jkollhomx kankru, l - għażla ta' tabelli ta 'konverżjoni, jekk għandux jingħata tagħrif dwar il- kontraindikazzjonijiet għat- treddigħ u dwar l- interazzjonijiet ma' opioids agonisti parzjali fit- tagħrif dwar il- prodott u fl- istudji meħtieġa biex tintwera l- bijoekwivalenza bil- prodott mediċinali ta 'referenza.
The arbitration procedure started on 24 January 2007 with the adoption of a list of questions.
Il- proċedura ta 'arbitraġġ inbdiet fl- 24 ta' Jannar ta 'l- 2007 bl- adozzjoni ta' lista ta 'mistoqsijiet.
The Rapporteur was Dr Karl Broich and Co-Rapporteur was Dr Eric Abadie.
Ir- rapporteur kien Dr Karl Broich u l- Ko- Rapporteur kien Dr Eric Abadie.
The Marketing Authorisation Holder provided written explanations on 13 April 2007.
Id- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq ipprovda spjegazzjonijiet bil- miktub fit- 13 ta' April ta 'l- 2007.
During their July 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Fentanyl- ratiopharm 25/ 50/ 75/ 100 µg/ h Matrixpflaster and associated names, that the objections raised by France should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Waqt il- laqgħa tagħhom ta 'Lulju ta' l- 2007, is- CHMP, fid- dawl tad- dejta globali ppreżentata u d- diskussjoni xjentifika fi ħdan il- Kumitat, kien tal- fehma li l- bilanċ bejn il- benefiċċju u r- riskju kien favorevoli għal Fentanyl- ratiopharm 25/ 50/ 75/ 100 µg/ h Matrixpflaster u ismijiet assoċjati, li l- objezzjonijiet imqajma minn Franza m' għandhomx jipprevjenu l- għoti ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq u li s- Sommarju tal - Karatteristiċi tal- Prodott, it- tikketta u l- fuljett ta' tagħrif ta 'l- Istat Membru ta' Referenza għandhom jiġu emendati.
A positive opinion was adopted by consensus 19 July 2007.
Fid- 19 ta 'Lulju ta' l- 2007 kienet adottata opinjoni pożittiva b' kunsens.
The list of the product names concerned is given in Annex I.
Il- lista ta 'ismijiet ta' prodotti konċernati tidher fl- Anness I.
The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Il- konklużjonijiet xjentifiċi huma mogħtija fl - Anness II, flimkien mas- Sommarju tal- Karatteristiċi tal- Prodott fl- Anness III.
The final opinion was converted into a Decision by the European Commission on 23 October 2007.
L- opinjoni finali nbidlet f' Deċiżjoni mill- Kummissjoni Ewropea fit- 23 ta 'Ottubru ta' l- 2007.
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
7 Westferry Circus, Canary Wharf, Londra, E14 4HB, Ir- Renju Unit Tel.
Marketing
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq
(Invented)
L- Applikant
Pharmaceutical
Isem Ivvintat
ratiopharm Arzneimittel Vertriebs- GmbH Albert-Schweitzer- Gasse 3, 1140 WIEN, Austria
ratiopharm Arzneimittel Vertriebs - GmbH Albert- Schweitzer - Gasse 3, 1140 WIEN, L- Awstrija
2 Austria
L- Awstrija
Fenturogenox 100 µg/ h - transdermales Matrixpflaster
Fenturogenox 100 µg/ h 100 µg/ h - transdermales Matrixpflaster
Fentanyl-ratio 25 µg/ h, dispositif transdermique
Fentanyl- ratio 25 µg/ h 25 µg/ h, dispositif transdermique
Fentanyl-ratio 50 µg/ h, dispositif transdermique
Fentanyl- ratio 50 µg/ h 50 µg/ h, dispositif transdermique
Fentanyl-ratio 75 µg/ h, dispositif transdermique
Fentanyl- ratio 75 µg/ h 75 µg/ h, dispositif transdermique
Fentanyl-ratio 100 µg/ h, dispositif transdermique
Fentanyl- ratio 100 µg/ h 100 µg/ h, dispositif transdermique
3 The Netherlands
L- Olanda
Fentanilo Matrix ratiomed 50 microgramos/ h parches transdérmicos EFG
Fentanilo Matrix ratiomed 50 microgramos/ h parches
Avenida de Burgos 16D, 5º Planta, 28036
Avenida de Burgos 16D, 5º Planta, 28036 Madrid, Spanja
Madrid, Spain
Ir- Renju Unit
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF FENTANYL- RATIOPHARM 25/ 50/ 75/ 100 µg/ h TTS AND ASSOCIATED NAMES (SEE ANNEX I)
SOMMARJU TOTALI TA ’ L- EVALWAZZJONI XJENTIFIKA TA ’ FENTANYL - RATIOPHARM U ISMIJIET ASSOĊJATI (ARA ANNESS I)
8 GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
8 ARGUMENTI GĦAL EMENDI TAS- SOMMARJU( I) TAL- KARATTERISTIĊI TAL -
the CHMP has recommended the granting of the Marketing Authorisation(s) and the amendment of the Summary of Product Characteristics, labelling and package leaflet which are set out in Annex III for Fentanyl-ratiopharm 25/ 50/ 75/ 100 µg/ h TTS and associated names (see Annex I).
il- CHMP irrakkomanda l- għoti ta ’ l- Awtorizzazzjoni( jiet) għat- Tqegħid fis- Suq u l- emenda tas - Sommarju tal- Karatteristiċi tal- Prodott, tikketta u fuljett ta ’ tagħrif li huma stabbiliti fl- Anness III għal Fentanyl- ratiopharm u ismijiet assoċjati (ara Anness I).
Fentanyl-ratiopharm 25 µg/ h TTS and associated names (see Annex I)
Fentanyl- ratiopharm 25 µg/ h TTS u ismijiet assoċjati miegħu (Ara Anness I)
Oral morphine
Doża ta ’ morfina orali
60-89 90-149 150-209 210-269 270-329 330-389 390-449 450-509 510-569 570-629 630-689
(milligramma/ 24 siegħa) < 60 60- 89 90- 149 150- 209 210- 269 270- 329 330- 389 390- 449 450- 509 510- 569 570- 629 630- 689 690- 749
25 50 75 100 125 150 175 200 225 250 275 13
(mikrogramma/ siegħa) 12. 5 25 50 75 100 125 150 175 200 225 250 275 300
By combining several transdermal patches, a fentanyl release rate of over 100 micrograms/ h can be achieved.
13 Bit- taħlit ta ’ bosta biċċiet ta’ garża transdermali, tista ’ tinkiseb rata ta ’ irħir ta ’ fentanyl il fuq minn 100 mikrogramma fis- siegħa.
A period of 7 days
Irid jintagħżel post ġdid fuq il- ġilda għal kull applikazzjoni,.
In chronic non-cancer pain, it might be preferable to initiate the treatment with immediate-release strong opoids (e. g. morphine) and to prescribe fentanyl transdermal patch after determination of the efficacy and the optimal dosage of the strong opioid.
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.
Breakthrough pain Studies have shown that almost all patients, despite treatment with a fentanyl patch, require supplemental treatment with potent rapid-release medicinal products to arrest breakthrough pain.
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.
15 Respiratory depression As with all potent opioids some patients may experience respiratory depression with Fentanyl- ratiopharm, and patients must be observed for this effect.
Dipressjoni respiratorja L- istess kif jiġri bl- użu tal- opjojdi qawwijin kollha, xi pażjenti jistgħu jbatu minn dipressjoni repiratorja meta jużaw Fentanyl- ratiopharm u l- pazjenti jridu jiġu sorveljati sewwa li ma ’ jkollhomx dan l- effett.
16 Due to limited experience in children under 12 years of age, Fentanyl-ratiopharm should be used in this age group only after careful consideration has been given to the benefit versus risk ratio.
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.
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)
17 4.6 Pregnancy and lactation
4. 6 Tqala u effetti fuq il- ħalib tas- sider
The safety of fentanyl in pregnancy has not been established.
Is- sigurta ’ fl- użu ta ’ fentanyl fit- tqala għada ma gietx stabbilita.
Skin and subcutaneous tissue disorders
uġigħ fil- bużżieqa ta ’ l- awrina, oligurja.
18 Very common: sweating, pruritus.
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Komuni ħafna: żieda fl- għaraq, ħakk.
20 Long-term carcinogenicity studies have not been performed.
Studji fit- tul dwar attivita 'karċinoġenika ma twettqux.
Fentanyl-ratiopharm 50 µg/ h TTS and associated names (see Annex I)
Fentanyl- ratiopharm 50 µg/ h TTS u ismijiet assoċjati miegħu (Ara Anness I)
30 5.1 Pharmacodynamic properties
5. 1 Tagħrif farmakodinamiku
Fentanyl-ratiopharm 75 µg/ h TTS and associated names (see Annex I)
Fentanyl- ratiopharm 75 µg/ h TTS u ismijiet assoċjati miegħu (Ara Anness I)
Table 1:
34 Tabella 1:
25 50 75 100 125 150 175 200 225 250 275 35
(mikrogramma/ siegħa) 12. 5 25 50 75 100 125 150 175 200 225 250 275 300
By combining several transdermal patches, a fentanyl release rate of over 100 micrograms/ h can be achieved.
35 Bit- taħlit ta ’ bosta biċċiet ta’ garża transdermali, tista ’ tinkiseb rata ta ’ irħir ta ’ fentanyl il fuq minn 100 mikrogramma fis- siegħa.
Breakthrough pain Studies have shown that almost all patients, despite treatment with a fentanyl patch, require supplemental treatment with potent rapid-release medicinal products to arrest breakthrough pain.
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.
37 Respiratory depression As with all potent opioids some patients may experience respiratory depression with Fentanyl- ratiopharm, and patients must be observed for this effect.
Dipressjoni respiratorja L- istess kif jiġri bl- użu tal- opjojdi qawwijin kollha, xi pażjenti jistgħu jbatu minn dipressjoni repiratorja meta jużaw Fentanyl- ratiopharm u l- pazjenti jridu jiġu sorveljati sewwa li ma ’ jkollhomx dan l- effett.
38 Due to limited experience in children under 12 years of age, Fentanyl-ratiopharm should be used in this age group only after careful consideration has been given to the benefit versus risk ratio.
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.
39 4.6 Pregnancy and lactation
4. 6 Tqala u effetti fuq il- ħalib tas- sider
40 Very common: sweating, pruritus.
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Komuni ħafna: żieda fl- għaraq, ħakk.
42 Long-term carcinogenicity studies have not been performed.
Studji fit- tul dwar attivita 'karċinoġenika ma twettqux.
Fentanyl-ratiopharm 100 µg/ h TTS and associated names (see Annex I)
Fentanyl- ratiopharm 100 µg/ h TTS u ismijiet assoċjati miegħu (Ara Anness I)
Table 1:
45 Tabella 1:
25 50 75 100 125 150 175 200 225 250 275 46
(mikrogramma/ siegħa) 12. 5 25 50 75 100 125 150 175 200 225 250 275 300
By combining several transdermal patches, a fentanyl release rate of over 100 micrograms/ h can be achieved.
46 Bit- taħlit ta ’ bosta biċċiet ta’ garża transdermali, tista ’ tinkiseb rata ta ’ irħir ta ’ fentanyl il fuq minn 100 mikrogramma fis- siegħa.