qanastek/EMEA-V3 huggingface dataset:
Oral ingestion of the fentanyl-containing gel may cause life-threatening hypoventilation or death.
Inġestjoni orali tal- ġell li fih il- fentanyl jista ’ jwassal għal ipoventilazzjoni li huwa ta ’ theddid għall - ħajja jew jista ’ jwassal għall- mewt.
Do not touch the gel or allow gel to touch the mouth or other mucosal areas.
Tmissx il- ġell u tħallix il- ġell imiss mal- ħalq jew partijiet mukużali oħrajn.
A potentially dangerous amount of fentanyl remains in the IONSYS system after use.
Ikun fadal ammont ta ’ fentanyl potenzjalment perikoluż fis- sistema IONSYS wara l- użu.
Please refer to section 6.6 for Special precautions for disposal.
Jekk jogħġbok ara sezzjoni 6. 6 għal Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema.
Remove the IONSYS system before a magnetic resonance imaging (MRI) procedure, cardioversion, or defibrillation.
Neħħi s- sistema IONSYS qabel proċedura ta ’ imaġini bir- reżonanza manjetika (MRI), kardjoverżjoni jew defibrillazzjoni.
Abuse potential and dependence
Potenzjal ta ’ abbuż u dipendenza
The active substance in IONSYS is fentanyl which has a well known abuse potential.
Is- sustanza attiva f’ IONSYS huwa fentanyl li għandu potenzjal magħruf ta ’ abbuż.
Physicians should evaluate patients for a history of drug abuse and follow such patients closely.
Tobba għandhom jevalwaw l- istorja tal- pazjent dwar abbuż ta ’ droga u l- pazjenti għandhom jiġu segwiti mill- qrib.
Since IONSYS is indicated only for a short-term treatment the risks related to the dependence potential are not of concern.
Billi IONSYS huwa indikat għal trattament għal żmien qasir il- potenzjal ta ’ riskju relatat mad - dipendenza m’ huwiex konċernanti.
There was also no evidence of abuse of the system during the clinical trials.
Ma kienx hemm evidenza ta ’ abbuż tas- sistema waqt il- provi kliniċi.
Respiratory depression
Dipressjoni respiratorja
As with all potent opioids, significant respiratory depression may occur with IONSYS; patients must be observed for these effects (see also Section 4.9).
Bħal b’ kull opioid qawwija, jista ’ jkun hemm dipressjoni respiratorja sinjifikanti b’ IONSYS; pazjenti għandhom jiġu osservati għal dawn l- effetti (ara anke Sezzjoni 4. 9).
The use of concomitant CNS-active medicinal products may increase the risk of respiratory depression (see Section 4.5).
L- użu konkomitanti ta ’ prodotti mediċinali attivi fis- sistema nervuża ċentrali jistgħu iżidu r- riskju ta ’ dipressjoni respiratorja (ara Sezzjoni 4. 5).
Chronic pulmonary disease
Mard pulmonari kroniku
In patients with chronic obstructive pulmonary disease or patients with conditions pre-disposing them to hypoventilation, more severe adverse reactions may be experienced.
F’ pazjenti b’ mard kroniku struttiv pulmonari jew pazjenti b’ kundizzjonijiet li jagħmluhom predisposti għal ipoventilazzjoni, jistgħu jiġu esperjenzati reazzjonijiet avversi aktar severi.
In such patients, opioids may decrease respiratory drive and increase airway resistance.
F’ dawn il- pazjenti, opioids jistgħu inaqqsu d- drive respiratorja u jżidu resistenza fil- passaġġ ta ’ l- arja
Head injuries and increased intracranial pressure
Feriti fir- ras u żieda fil- pressjoni intrakranjali
IONSYS should not be used in patients who may be particularly susceptible to the intracranial effects of CO2 retention, such as those with evidence of increased intracranial pressure, impaired consciousness, or coma.
IONSYS m’ għandux jintuża f’ pazjenti li huma partikolarment suxxettibbli għall- effetti intrakranjali ta ’ ritenzjoni ta ’ CO2, bħal dawk b’ evidenza ta ’ żieda ta ’ pressjoni intrakranjali, konoxxenza indebolita, jew koma.
Opioids may obscure the clinical course of patients with head injury.
Opioids jistgħu joskuraw il- kors kliniku ta ’ pazjenti b’ ferita f’ rashom.
IONSYS should be used with caution in patients with brain tumours.
IONSYS għandu jintuża b’ attenzjoni f’ pazjenti b’ tumuri fil- moħħ.
Cardiac disease
Mard kardijaku
Fentanyl may produce bradycardia or hypotension and should therefore be administered with caution to patients with bradyarrhythmias or any significant cardiovascular disease.
Fentanyl jista ’ jipproduċi bradikardija jew ipotensjoni u għalhekk għandu jingħata b’ kawtela lil pazjenti bi bradiarritmiji jew kwalunkwe mard kardjovaskulari sinjifikanti.
Paralytic ileus
Ileus paralitiku
IONSYS should be used with caution in patients with paralytic ileus.
IONSYS għandu jintuża b’ kawtela f’ pazjenti b’ ileus paralitiku.
Hepatic disease
Mard epatiku
Fentanyl is metabolized into inactive metabolites in the liver.
Fentanyl huwa metabolizzat f’ metaboliti inattivi fil- fwied.
Hepatic disease may delay elimination.
Mard epatiku jista ’ jittardja l - eliminazzjoni.
Patients with hepatic impairment should be observed carefully for signs of fentanyl toxicity.
Pazjenti b’ indeboliment epatiku għandhom jiġu osservati bir- reqqa għal sinjali ta ’ tossiċità ta ’ fentanyl.
Renal disease
Mard renali
Less than 10% of administered fentanyl is excreted unchanged by the kidney.
5 Inqas minn 10% ta ’ fentanyl mogħti jiġi eskretat mingħajr bdil mill- kliewi.
Data obtained with intravenous fentanyl in
Kontra għal morfina, l - ebda metaboliti attivi ta ’ fentanyl huma eliminati mill- kliewi.
5 patients with renal failure suggest that the volume of distribution of fentanyl may be changed by dialysis.
Tagħrif ottenut b’ fentanyl mogħti ġol - vini f’ pazjenti b’ insuffiċjenza renali jissuġġerixxu li l- volum ta ’ distribuzzjoni ta ’ fentanyl jista ’ jinbidel b’ dijalisi.
This may affect serum concentrations.
Dan jista ’ jaffettwa konċentrazzjonijiet ta ’ serum.
If patients with renal impairment receive IONSYS, they should be observed carefully for signs of fentanyl toxicity.
Jekk pazjenti b’ insuffiċjenza renali jirċievu IONSYS, dawn għandhom jiġu osservati bir- reqqa għal sinjali ta ’ tossiċità ta ’ fentanyl.
Limited data on pharmacokinetics, safety and efficacy are available for the use of IONSYS in patients > 75 years.
Hemm tagħrif limitat fuq farmakokinetika, sigurtà u effikaċja għall- użu ta ’ IONSYS f’ pazjenti > 75 sena.
Elderly patients should be observed carefully for signs of fentanyl toxicity.
Pazjenti anzjani għandhom jiġu osservati bir- reqqa għal sinjali ta ’ tossiċità ta ’ fentanyl.
Obese patients
Pazjenti obeżi
Efficacy and safety in patients with body mass index greater than 40 has not been established.
Ma ġietx stabbilita l- effikaċja u sigurtà f’ pazjenti b’ indiċi tal- massa tal- ġisem ikbar minn 40.
Hearing impairment
Indeboliment fis- smiegħ
IONSYS should be used with caution in patients with hearing impairment who might not be able to hear the audible signals from the system.
IONSYS għandu jintuża b’ kawtela f’ pazjenti b’ indeboliment fis- smiegħ minħabba li jista ’ jkun li ma jkunux jistgħu jisimgħu is- sinjali li jinstemgħu mis- sistema.
Thoracic/ chest and upper abdominal surgeries
Kirurġiji torassiċi / fis- sider u addominali fin- naħa ta ’ fuq
Only limited data are available in patients with thoracic/ chest and upper abdominal surgeries.
Hu disponibbli tagħrif limitat f’ pazjenti b’ kirurġiji torassiċi / fis- sider u addominali fin- naħa ta ’ fuq.
IONSYS should therefore be used with caution in these patients.
IONSYS għalhekk għandu jintuża b’ kawtela f’ dawn il- pazjenti.
Cystic Fibrosis
Fibrożi Ċistika
Efficacy and safety in patients with cystic fibrosis has not been established.
Ma ġietx stabbilita l- effikaċja u sigurtà f’ pazjenti b’ fibrożi cistika.
Physical status
Stat fiżiku
The safety of IONSYS has not been established in patients with American Society of Anesthesiologists (ASA) physical status classification IV.
Ma ġietx stabbilita is- sigurtà ta ’ IONSYS f’ pazjenti b’ klassifikazzjoni IV tal- istat fiżiku skond is - Soċjetà Amerikana tal- Anestesjoloġisti (ASA).
With each new IONSYS application the patient may use IONSYS more frequently than during the remainder of the 24 hour dosing period, due to a lower absorption of fentanyl from the system for the first few hours (see section 5.2).
Ma kull applikazzjoni ġdida ta ’ IONSYS il- pazjent jista ’ juża IONSYS b’ mod iktar frekwenti milli waqt il- perijodu ta ’ dożaġġ ta ’ 24 siegħa li jkun għad fadal, minħabba assorbiment iktar baxx ta ’ fentanyl mis- sistema għall- ewwel ftit siegħat (ara sezzjoni 5. 2)
Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Interaction studies have only been performed in adults.
Saru studji dwar l- effett ta ’ mediċini ta ’ affarijiet oħra fuq l- effett farmaewtiku tal- prodott fl- adulti.
The concomitant use of other central nervous system depressants, including other opioids, sedatives or hypnotics, general anaesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, sedating antihistamines, and alcoholic beverages, may produce additive depressant effects.
L- użu konkomitanti ta ’ dipressanti tas- sistema nervuża ċentrali oħrajn, inkluż opioids oħrajn, sedattivi, jew ipnotiċi, anestesija ġenerali, phenothiazines, kalmanti, rilassanti tal- muskoli skeltrali, antistamini sedattivi, u xorb alkoħoliku, jistgħu jipproduċu effetti dipressanti addizzjonali.
Hypoventilation, hypotension, and profound sedation or coma may occur.
Jistgħu iseħħu ipoventilazzjoni, ipotensjoni, u sedazzjoni profonda jew koma.
Therefore, the use of any of these medicinal products concomitantly with IONSYS requires special patient care and observation.
Għalhekk, l- użu ta ’ kwalunkwe minn dawn il- prodotti mediċinali flimikien ma ’ IONSYS jirrikjedi kura speċjali u osservazzjoni fuq il - pazjent.
Fentanyl, a high clearance active substance, is rapidly and extensively metabolised mainly by CYP3A4.
Fentanyl, sustanza attiva bi tneħħija għolja, hija metabolizzata b’ mod rapidu u estensiv prinċipalment permezz ta ’ CYP3A4.
Itraconazole, a potent CYP3A4 inhibitor, at 200 mg/ day orally for 4 days had no significant effect on the pharmacokinetics of intravenous fentanyl.
Intraconazole, inibitur qawwi ta ’ CYP3A4, b’ 200mg/ kuljum mill- ħalq għal 4 ijiem ma kellu ebda effett sinjifikattiv fuq il- farmakokinetika ta ’ fentanyl mogħti mill- vini.
Oral ritonavir, one of the most potent CYP3A4 inhibitors, reduced the clearance of intravenous fentanyl by two thirds.
Ritonavir orali, wieħed mill- iktar inibituri qawwija ta ’ CYP3A4, naqqas b’ żewġ terzi t- tneħħija ta ’ fentanyl mogħti mill- vini.
The concomitant use of potent CYP3A4 inhibitors such as ritonavir with IONSYS may result in an increase in fentanyl plasma concentrations, which could increase or prolong both the therapeutic and adverse events, and may cause serious respiratory depression.
L- użu ta ’ inibituri qawwija ta ’ CYP3A4 bħal ritonavir flimkien ma ’ IONSYS jista ’
In this situation, special patient care and observation are appropriate.
F’ din is- sitwazzjoni, huwa approprjat li jkun hemm attenzjoni speċjali u osservazzjoni tal- pazjent.
The concomitant use of ritonavir or other CYP3A4 inhibitors and IONSYS is not recommended unless the patient is closely monitored.
L- użu ta ’ ritonavir jew inibitur ta ’ CYP3A4 ieħor flimkien ma ’ IONSYS mhux irrakkomandat sakemm il- pazjent hu monitorjat bir - reqqa.
6 IONSYS 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.
IONSYS mhux irrakkomandat għal użu f’ pazjenti li ħadu inibituri ta ’ monoamine oxidase (MAO) fi żmien 14- il jum minħabba li ġiet irrapurtata potenzjazzjoni severi u mhux prevedibbli bl- inibituri ta ’ MAO ma ’ analgesiċi opioid.
Pregnancy and lactation
4. 6 Tqala u Treddigħ
There are no adequate data from the use of fentanyl in pregnant women.
M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ fentanyl waqt it- tqala.
Studies in animals have shown reproductive toxicity (see section 5.3).
Studji fuq bhejjem urew tossiċità fis- sistema riproduttiva (ara sezzjoni 5. 3).
The potential risk for humans is unknown.
Mhux magħruf ir- riskju potenzjali fuq il- bnedmin.
IONSYS should not be used in pregnancy unless clearly necessary.
IONSYS m’ għandux jintuża waqt it- tqala sakemm mhux neċċessarju.
Administration during childbirth is not recommended because fentanyl crosses the placenta and the foetal respiratory centre is sensitive to opiates.
Mhux irrakkomandat l- għoti waqt it- twelid minħabba li fentanyl jgħaddi mill- plaċenta u ċ- ċentru respiratorju tal- fetu huwa sensittiv għall- opiates.
If IONSYS is administered, an antidote for the child should be readily available.
Jekk IONSYS jingħata, għandu jkun disponibbli antidot għat- tarbija.
Following long-term treatment fentanyl may cause withdrawal in the newborn.
Wara trattament għal żmien twil fentanyl jista ’ jikkawża withdrawal fit- tarbija tat- twelid.
Fentanyl is excreted into maternal milk.
Fentanyl jiġi eskretat għal ġol- ħalib tal- omm.
Breast-feeding is not recommended for 24 hours following removal of IONSYS.
It- treddigħ mhux rakkomandat għal 24 siegħa wara t - tneħħija ta ’ IONSYS.
Women of childbearing potential/ Fertility
Nisa b’ potenzjal ta ’ tqala/ fertilità
See section 5.3 (reproductive toxicology)
Ara sezzjoni 5. 3 (tossikoloġija riproduttiva)
Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
IONSYS has major influence on the ability to drive and use machines.
IONSYS għandu influwenza qawwija ħafna fuq il- ħila biex issuq u tħaddem magni.
Fentanyl can cause dizziness and somnolence, therefore patients should only drive vehicles or operate heavy machinery if sufficient time has elapsed after the administration of IONSYS.
Fentanyl jista ’ jikkawża sturdament u ngħas, għalhekk pazjenti għandhom isuqu vetturi jew iħaddmu magni biss jekk għadda ħin suffiċjenti wara l- għoti ta ’ IONSYS.
Undesirable effects
4. 8 Effetti mhux mixtieqa
In controlled clinical studies, the safety of IONSYS 40 micrograms was evaluated in a total of 791 patients.
Fi studji kliniċi kontrollati, is- sigurtà ta ’ IONSYS 40 mikrogramma ġiet evalwata f’ total ta ’ 791 pazjent.
The most commonly reported adverse events were nausea, vomiting, headache and pruritus.
L- iktar effetti avversi komuni li ġew irrappurtati kienu nawżea, remettar, uġigħ ta ’ ras u ħakk.
These were mostly of mild to moderate severity.
Dawn kienu l- iktar ta ’ severita` ħafifa għal moderata.
The following adverse reactions that are at least possibly related to treatment have been reported in the clinical trials; not all of these reactions have been uniformly attributed to IONSYS by the investigators, therefore causation cannot be established.
Ir- reazzjonijiet avversi li ġejjin li huma mill- inqas possibilment relatati mat- trattament ġew rappurtati fil- provi kliniċi; mhux ir- reazzjonijiet kollha ġew uniformement attribwiti lil IONSYS mill- investigaturi, għalhekk ma jista’ x jiġi stabbilit il - kawżalità.
Common Undesirable Effects (> 1/ 100 to < 1/ 10)
Effetti Mhux Effetti Mhux Effetti Mhux Mixtieqa Mhux Mixtieqa Komuni Mixtieqa Komuni komuni (≥1/ 1, 000 sa (≥1/ 100 sa < 1/ 10) Ħafna (≥1/ 10) < 1/ 100) Disturbi vaskulari
Vascular Disorders
Vażodilitazzjoni
Dizziness Somnolence
Sturdament Ngħas
Agitation Abnormal dreams Anxiety Insomnia Hallucinations Depression Hypesthesia
Aġitazzjoni Ħolm anormali Anzjetà Nuqqas ta ’ rqad Alluċinazzjonijiet
Uncommon Undesirable Effects (> 1/ 1000 to < 1/ 100) Nervousness Tremor Vertigo
Depressjoni Ipoestesija Nervożità Rogħda Vertigo
Cardiac disorders
Disturbi fil- qalb Disturbi fil - metaboliżmu u n - nutrizzjoni
Hypotension
Ipotensjoni
Tachycardia Bradycardia Hypertension Migraine Syncope
Takikardija Bradikardija Ipertensjoni Mugranja Sinkope Uġigħ fil- muskoli / Majalġja Edima Ipokalċimja Ipogliċemija Ipokalimja
Hypoxia
Ipoksja
Apnea Hiccup Hypoventilation Dyspnea Lung disorder Cough increased Rhinitis
Apneja Sulluzzu Ipoventilazzjoni Qtugħ ta ’ nifs Disturbi pulmonari Żieda fis- sogħla Rinite
Gastro-intestinal disorders
Disturbi gastro - intestinali
Nausea Vomiting
Nawseja Rimettar
Constipation Flatulence
Stitikezza Gass fl- istonku
Eructation Gastro-intestinal disorder Ileus Dry mouth Dyspepsia Anorexia
Tifwiq Disturb gastrointestinali Ileus Ħalq xott Dispepsja Anoressija
Rash Wound site inflammation edema
Raxx Infjammazzjoni fil- post tal- ferita Edima
Urinary retention
Ritenzjoni urinarja
Oliguria Urination impaired
Oliguria Indeboliment fl- awrina
Headache, *ASRs - erythema
Uġigħ ta ’ ras, * ASRs - eritema
*ASRs – itching, vesicles Fever
* ASRs – ħakk, bżieżaq żgħar Deni
*ASRs– papules/ pustules, sweating, dry & flaky skin, burning Abdominal pain Back pain Pain Chills
* ASRs – nfafet/ ponot, għaraq, ġilda xotta u titfarfar, ħruq Uġigħ addominali Uġigħ fid- dahar Uġigħ Ksieħ
*ASRs = application site reactions
* ASRs = Reazzjonijiet fis- sit tal- applikazzjoni
Overdose
4. 9 Doża eċċessiva
The manifestations of fentanyl overdosage are an extension of its pharmacologic actions, the most serious effect being respiratory depression.
Il- manifestazzjonijiet ta ’ dożi eċċessivi ta ’ fentanyl huma estenzjoni tal- azzjonijiet farmakoloġiċi tiegħu, l- iktar effett serju huwa dipressjoni respiratorja.
8 Treatment
8 Għal maneġġjar ta ’ dipressjoni respiratorja, kontro- miżuri immedjati jinkludu t- tneħħija tas- sistema IONSYS u l- istimulazzjoni tal- pazjent b’ mod fiżiku jew verbali.
These actions can be followed by administration of a specific opioid antagonist such as naloxone.
Dawn l- azzjonijiet jistgħu jiġu segwiti b’ għoti ta ’ antagonista speċifika tal- opioid bħal naloxone.
Respiratory depression following an overdose may outlast the duration of action of the opioid antagonist.
Dipressjoni respiratorja wara doża eċċessiva tista ’ ddum iktar mid- durata tal- azzjoni tal- antagonista tal- opioid.
The half-life of the antagonist may be short; therefore, repeated administration or continuous infusion may be necessary.
Il- half- life tal- antagonista tista tkun qasira; għalhekk, jista ’ jkun hemm neċessita` ta ’ għoti ripetuta jew infużjoni kontinwa.
Reversal of the narcotic effect may result in acute onset of pain and release of catecholamines.
Riversjar tal- effett narkotiku jista ’ jwassal għal attakk akut ta ’ uġigħ u l- ħelsien ta ’ catecholamines.
If the clinical situation warrants, a patent airway should be established and maintained, possibly with an oropharyngeal airway or endotracheal tube and oxygen should be administered and respiration assisted or controlled, as appropriate.
Jekk is- sitwazzjoni klinika tirrikjedi, għandu jiġi stabbilit u mantenut passaġġ tal- arja prodott, possibilment mill- orofarinġi jew b’ tubu endotrakjali u ossiġnu għandu jingħata u r- respirazzjoni għandha tkun assistita jewkontrollata, kif ikun hemm bżonn.
Adequate body temperature and fluid intake should be maintained.
Għandha tinżamm temperatura adegwata tal- ġisem u teħid ta ’ fluwidi.
If severe or persistent hypotension occurs, hypovolemia should be considered and the condition should be managed with appropriate parenteral fluid therapy.
Jekk ikun hemm ipotensjoni severi u persistenti, għandu jkun ikkunsidrat hypovolemia u l- kundizzjoni għandha tkun kontrollata b’ terapija approprijata ta ’ fluwidu parenterali.
Opioid analgesics (phenylpiperidine derivative), ATC code:
Analġesiċi opioid (phenylpiperidine derivative), Kodiċi ATC:
Fentanyl is an opioid analgesic, interacting predominantly with the opioid μ -receptor.
Fentanyl huwa analġesiku opioid, li jinteraġixxi b’ mod predominanti mal - μ- riċettur ta ’ l- opiod.
Its primary therapeutic actions are analgesia and sedation.
L - azzjoni terapewtika primarja huma analġesija u sedazzjoni.
Its secondary pharmacological effects are respiratory depression, bradycardia, hypothermia, constipation, miosis, physical dependence and euphoria.
L- effetti farmakoloġiċi sekondarji huma dipressjoni respiratorja, bradikardija, ipotermja, stitikezza, mijożi, dipendenza fiżika u ewforja.
Minimum effective analgesic serum concentrations of fentanyl in opioid-naïve patients treated for acute post-operative pain range from 0.2 to 1.2 ng/ ml; undesirable effects increase in frequency at serum levels above 2 ng/ ml.
Konċentrazzjoni ta ’ serum analġesiku effettiva minima ta ’ fentanyl f’ pazjenti li m’ għandhomx esperjenza ta ’ opioid trattati għal uġigħ akut wara operazzjoni ta ’ bejn 0. 2 u 1. 2 ng/ ml; effetti mhux mixtieqa jiżdiedu fil- frekwenza f’ livelli ta ’ serum ‘ il fuq minn 2ng/ ml.
At the initiation of each dose, an electrical current moves a pre-determined amount of fentanyl from the active substance-containing reservoir through the skin and into systemic circulation.
Mall- bidu ta ’ kull doża, kurrent elettriku jmexxi ammont predeterminat ta ’ fentanyl mir- riżerva li żżomm is- sustanza attiva li jgħaddi minn ġol- ġilda għal ġo ċirkulazzjoni sistemika.
IONSYS delivers a nominal dose of 40 micrograms fentanyl over each 10-minute dosing period.
IONSYS jitrasmetti doża nominali ta ’ 40 mikrogramma fentanyl għal kull perijodu ta ’ dożaġġ ta ’ 10 minuti.
Upon system removal after the last dose, decline in serum fentanyl concentration is similar to that of intravenous fentanyl.
Meta titneħħa s- sistema wara l- ahhar doża, tnaqqis fil- konċentrazzjoni ta ’ fentanyl fis- serum huwa simili għal dak ta ’ fentanyl mogħti mill- vini.
When IONSYS is applied without activating the current, the average absorption rate of fentanyl over 24 hours was 2.3 micrograms fentanyl/ hour, indicating minimal passive delivery.
Meta IONSYS jiġi applikat mingħajr ma jiġi attivat il- kurrent, ir- rata medja ta ’ assorbiment ta ’ fentanyl fuq medda ta ’ 24 siegħa kienet ta ’ 2. 3 mikrogrammi fentanyl/ siegħa, li jindika trasmissjoni passiva minima.
Average serum concentrations observed in post-surgical patients were in the range of 0.4-1.5 ng/ ml over a 24 hour dosing period.
Konċentrazzjonijiet medji ta ’ serum osservati f’ pazjenti wara operazzjoni kienu fil- medda ta ’ 0. 4 - 1. 5ng/ ml fuq perijodu ta ’ dożaġġ ta ’ 24 siegħa.
In general the maximum serum fentanyl concentration occurs approximately 15 minutes after the initiation of a dose.
Ġeneralment, il- konċentrazzjoni massima ta ’ fentanyl fis- serum isseħħ madwar 15- il minuta wara l- bidu tad- doża.
Following an on-demand dose of fentanyl by IONSYS, fentanyl has an absorption half-life of approximately 15 minutes.
Wara doża ta ’ fentanyl fuq rikjesta b’ IONSYS, fentanyl għandu half- life ta ’ assorbiment ta ’ madwar 15- il minuta.
Fentanyl exhibits three compartment distribution pharmacokinetics.
Fentanyl juri distribuzzjoni farmakokinetika ta ’ tliet kompartamenti.
With intravenous administration, the initial distribution half-life is approximately 6 minutes; the second distribution half-life is 1 hour, and the terminal half-life is 13 hours.
B’ għoti mill- vini, id - distibuzzjoni half- life tal- bidu hija ta ’ madwar 6 minuti; it- tieni distribuzzjoni half- life hija siegħa; u l - half- life terminali hija 13- il siegħa.
9 The average volume of distribution for fentanyl at steady state is 6 l/ kg, the average clearance is 53 l/ h.
Il- volum medju ta ’ distribuzzjoni għal fentanyl fi stat fiss huwa 6 l/ kg, il- medja ta ’ tneħħija hija 53 l/ h.
Elderly, cachectic, or debilitated patients may have a reduced clearance of fentanyl and, therefore, the active substance may have a prolonged terminal half-life in these patients.
Anzjani, pazjenti kakektiċi jew debilitati jista ’ jkollhom tneħħija mnaqqsa ta ’ fentanyl u, għalhekk, is - sustanza attiva jista ’ jkollha half- life terminali itwal f’ dawn il- pazjenti.
Fentanyl is metabolized primarily in the liver.
Fentanyl huwa metabolizzat primarjament mill- fwied.
Around 75% of fentanyl is excreted into the urine, mostly as metabolites, with less than 10% as unchanged active substance.
Madwar 75% tal- fentanyl huwa eskretat fl- awrina, l- iktar bhala metaboliti;
About 9% of the dose is recovered in the faeces, primarily as metabolites.
Madwar 9% mid- doża tiġi rkuprata fil- purgar, primarjament bħala metaboliti.
Mean values for unbound fractions of fentanyl in plasma are estimated to be between 13 and 21%.
Valuri medji għal frazzjonijiet mhux imwaħħla ta ’ fentanyl fil- plażma huma stmati li jkunu bejn 13 u 21%.
Skin does not appear to metabolize fentanyl delivered transdermally.
Ma jidhirx li l- ġilda timmetabolizza fentanyl li jiġi mgħoddi minn ġol- ġilda.
None of the four demographic factors studied [weight (lean/ obese), age, race, or gender] had a significant effect on active substance exposure (AUC) following use of IONSYS.
L- ebda mill- erba fatturi demografiċi studjati [piż (magħlub/ obeż), età, razza, jew sess] ma kellhom effett sinjifikanti fuq espożizzjoni tas- sustanza attiva (AUC) wara l- użu ta ’ IONSYS.
Absorption of fentanyl from IONSYS is similar whether applied to the upper outer arm or chest.
Assorbiment ta ’ fentanyl minn IONSYS huwa simili kemm jekk applikat fuq in- naħa ta ’ barra ta ’ fuq tad- driegħ jew fuq is- sider.
When the system is applied on the lower inner arm, fentanyl amount absorbed is approximately 20% lower than the upper outer arm or chest.
Meta s- sistema tiġi applikata fuq in- naħa ta ’ isfel u ta ’ ġewwa tad- driegħ, l- ammont ta ’ fentanyl assorbit huwa madwar 20% iktar baxx minn- naħa ta ’ fuq ta ’ barra tad- driegħ jew is- sider.
Fentanyl pharmacokinetics appear to be similar with both single and multiple 24 hour applications.
Il - farmakokinetika ta ’ fentanyl tidher simili kemm f’ applikazzjoni singoli jew multipli ta ’ 24 siegħa.
Systemic absorption of fentanyl increased as a function of time independent of frequency of dosing, with the initial dose being approximately 40% of the nominal 40 micrograms dose absorbed between 12 and 24 hours after application.
Assorbiment sistemiku ta ’ fentanyl jiżdied bħala funzjoni ta ’ ħin indipendentement mill- frekwenza ta ’ dożaġġ, bid- doża tal- bidu tkun ta ’ madwar 40% tad- doża nominali ta ’ 40 mikrogramma assorbiti bejn 12 u 24 siegħa wara l- applikazzjoni.
The pharmacokinetic absorption profile will repeat with each application to a new skin site, therefore with each new application absorption is less when IONSYS is first applied, and consequently a fall in plasma fentanyl concentrations will occur.
Il- profil ta ’ assorbiment farmakokinetiku jirrepeti ruħu ma ’ kull applikazzjoni fuq post ġdid fuq il- ġilda, għalhekk ma ’ kull applikazzjoni ġdida l- assorbiment huwa inqas meta IONSYS jiġi applikat l- ewwel darba, u konsegwentement iseħħ tnaqqis fil - konċentrazzjonijiet ta ’ fentanyl fil- plażma.
Preclinical safety data
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Non-clinical data revealed no special hazard for humans based on conventional studies of repeated dose toxicity.
Fi studji li m’ humiex kliniċi, magħmula fuq studji konvenzjonali ta ’ effett tossiku minn dożi ripetuti ma ’ wrew l- ebda periklu speċjali għall- bnedmin.
Standard reproductive and developmental toxicity studies have been carried out using parenteral administration of fentanyl.
Studji standard ta ’ tossiċità riproduttiva jew ta ’ żvilupp saru bl- użu ta ’ għoti parenterali ta ’ fentanyl.
In a rat study fentanyl did not influence male fertility.
Fi studju fuq firien, fentanyl ma influwenzax il- fertilità maskili.
Studies with female rats revealed reduced fertility and enhanced embryo mortality.
Studji fuq firien feminili wrew fertilità mnaqqsa u żieda fil- mortalità tal- embriju.
An intravenous dose of up to 0.4mg/ kg/ day for 14 days to female rats produced no effects on fertility.
Dożi mogħtija mill- vini sa 0. 4mg/ kg/ ġurnata għal 14- il jum fuq firien feminili ma pproduċew l- ebda effetti fuq fertilità.
A single daily bolus dose of fentanyl impaired fertility in rats when given in intravenous doses of 0.3 times the human dose for 12 days.
Doża bolus singola ta ’ kuljum ta ’ fentanyl indeboliet il- fertilità fil- firien meta ingħataw dożi mogħtija mill- vini ta ’ 0. 3 tad- doża tal - bniedem għal 12- il jum.
More recent studies showed that effects on the embryo were due to maternal toxicity and not to direct effects of the substance on the developing embryo.
Studji iktar riċenti juru li l- effetti fuq l- embriju kienu kkawżati minn tossiċità materna u mhux minn effetti diretti tas- sustanza fuq l- embriju fl- iżvilupp.
There were no indications for teratogenic effects in studies in two species (rats and rabbits).
Ma kien hemm l- ebda indikazzjonijiet ta ’ effetti teratoġeniċi fi studji fuq żewġ speċji (firien u fniek).
In a study on pre- and postnatal development the survival rate of offspring was significantly reduced at doses which slightly reduced maternal weight.
Fi studju fuq żvilupp ta ’ qabel u wara t- twelid ir - rata ta ’ sopravivenza tal- wild kien imnaqqas b’ mod sinjifikanti f’ dożi li naqqsu l- piż matern bi ftit.
This effect could either be due to altered maternal care or a direct effect of fentanyl on the pups.
Dan l- effett jista ’ jkun minħabba bdil fil- kura materna jew effett dirett tal- fentanyl fuq iż- żgħar.
Effects on somatic development and behaviour of the offspring were not observed.
Ma ġewx osservati l- effetti fuq l- iżvilupp somatiku u l- imġiba tal- wild.
Mutagenicity testing in bacteria and in rodents yielded negative results.
Ittestjar għal mutaġeniċità f’ batteri u annimali gerriema taw riżultati negattivi.
Fentanyl induced mutagenic effects in mammalian cells in vitro, comparable to other opioid analgesics.
Fentanyl induċa effetti mutaġeniċi f’ ċelluli mammiferi in vitro, paragunabbli għal analġesiċi opioid oħrajn.
A mutagenic risk for the use of therapeutic doses seems unlikely since effects appeared only at high concentrations.
Jidher improbabbli li jkun hemm riskju mutaġeniku għal dożi terapewtiċi minħabba li effetti dehru biss f’ konċentrazzjonijiet għoljin.
The carcinogenicity of fentanyl has not been studied.
Ma ġiex studjat il- karċinoġeniċità ta ’ fentanyl.
See Section 4.9 Overdose.
Tossiċità akuta: ara Sezzjoni 4. 9 Doża eċċessiva.
List of excipients
6. 1 Lista ta ’ sustanzi mhux attivi
Bottom housing assembly:
Kif inhu mmuntat l- għata ta ’ taħt
- glycol-modified polyethylene terephthalate
- glycol- modified polyethylene terephthalate
- anode hydrogel: purified water, sodium hydroxide, polacrilin and polyvinyl alcohol
- hydrogel anodiku: ilma ppurifikat, sodium hydroxide, polacrilin u polyvinyl alcohol.
- anode electrode: silver foil and electrically conductive adhesive tape (ECAT).
- elettrodu anodiku: fojl tal- fidda u tejp adeżiv li jikkonduċi l- elettriku (ECAT)
- cathode electrode: trilaminate of silver chloride composite material, silver foil, ECAT.
- elettrodu katodiku: tliet safef ta ’ materjal kompost ta ’ silver chloride, fojl tal- fidda, ECAT
- skin adhesive: polybutene, resin ester.
- adeżiv tal- ġilda: polybutene, ester tar- reżina.
- liner: polyester film, silicone.
- liner: kisja tal- polyester, silikon film
Incompatibilities
6. 2 Inkompatibilitajiet
Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
1 year Use immediately after opening.
Sena Uża immedjatament wara li jinfetaħ.
Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Each IONSYS system is individually packaged in a rectangular sealed foil sachet, together with a moisture absorber.
Kull sistema IONSYS hi ppakkjata individwalment f’ qartas rettangolari tal- fojl issiġillat flimkien ma ’ assorbent tal- umidità.
The sachet foil is comprised of a lamination of nylon, aluminium foil and a heat seal layer of a copolymer of polyethylene and polymethacrylic acid.
Il- qartas tal- fojl huwa magħmul minn laminazzjoni ta ’ najlon, fojl tal- aluminju u saff ta ’ copolymer ta ’ polyethylene polymethacrylic acid issiġillat bis- sħana.
Each sachet is packaged in a folding cardboard carton.
Kull pakkett huwa ppakkjat f’ kaxxa tal- kartun li tintlewa.
There is one unit per carton.
F’ kull kartuna jkun hemm unit wieħed.
Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
Contact with the gel can be harmful to humans.
Kuntatt mal- ġell jista ’ jkun ta ’ periklu għall- bniedem.
If the fentanyl gel contacts the skin during application or removal, the area should be washed with copious amounts of water.
Jekk il- ġell ta ’ fentanyl imiss mal- ġilda waqt l - applikazzjoni jew tneħħija, is- sit għandu jinħasel b’ ħafna ilma.
Soap, alcohol, or other solvents should not be used to remove the gel because they may enhance the active substances’ ability to penetrate the skin.
M’ għandhomx jintużaw sapun, alkoħol, jew solventi oħrajn sabiex jitneħħa l- ġell minħabba li dawn jistgħu iżidu l- abilità tas- sustanzi attivi sabiex jippenetraw il- ġilda.
IONSYS Testing Instructions for the Pharmacist or Other Heath Care Professional (To be Performed Prior to Dispensing).
Struzzjonijiet dwar ittestjar ta ’ IONSYS għall- Ispiżjar jew Professjonista tas- Saħħa ieħor (Li għandhom isiru qabel ma jingħata)
Each IONSYS system should be tested before it is dispensed to a patient to ensure the system is functional.
Kull sistema IONSYS għanda tiġi ttestjata qabel ma tingħata lill- pazjent sabiex jiġi żgurat li s- sistema hija funzjonabbli.
This can be done by pressing the recessed dosing button of the IONSYS, with the IONSYS still in its sealed sachet.
Dan jista ’ jsir billi tingħafas il- buttuna riċeduta ta ’ IONSYS, IONSYS meta jkun għadu fil- pakkett siġillat.
No medicinal product is delivered from the system unless IONSYS is applied to the skin.
L- ebda prodott mediċinali ma jgħaddi mis- sistema sakemm IONSYS ma jiġix applikat fuq il- ġilda.
Therefore 80 doses and 24 hours of use are still available after the following functionality test is performed:
Għalhekk 80 doża u 24 siegħa ta ’ użu jibqġhu disponibbli wara li jkun sar it- test ta ’ funzjonalità segwenti:
Hold the unopened foil sachet that contains IONSYS.
Żomm il- qartas tal- fojl magħluq li fih IONSYS.
By feel, determine where the IONSYS system is, and which side of IONSYS is rounded.
Billi tħoss, sib fejn qiegħda s- sistema IONSYS, u liema hi n- naħa ta ’ IONSYS li ġejja fit- tond.
With the rounded side facing up, run a finger along the unit until you feel the recessed button on one end.
Bin- naħa t- tundjata lejn in- naħa ta ’ fuq, mexxi subgħajk tul il- unit sakemm tħoss il- buttuna riċeduta f’ tarf minnhom.
Firmly press and release the button twice within 3 seconds
Għafas sew u ħalli l- buttuna darbtejn fi 3 sekondi
a) Immediately, a single audio beep will be emitted confirming that IONSYS unit is functional and can be dispensed.
a) Immedjatament, jinstema ħoss awdjo wieħed li jikkonferma li l- unit IONSYS huwa funzjonabbli u jista ’’ jiġi mogħti
b) After 4 minutes, IONSYS will beep for about 15 seconds.
11 b) Wara 4 minuti, IONSYS jagħmel ħoss għal madwar 15- il sekonda.
This is normal and indicates that the IONSYS is not in contact with the skin.
Din hi ħaġa normali u tindika li IONSYS mhux f’ kuntatt mal- ġilda.
This beeping alarm does not impact the functionality of IONSYS.
Dan il- ħoss, ma jaffettwax il- funzjonalita` tas- sistema IONSYS.
If neither the single beep emitted upon double-pressing the dosing button nor the 15 second beeping after 4 minutes are heard, return the IONSYS in its intact package to the manufacturer.
Jekk ma jinstemax il- ħoss waħdani wara li tingħafas darbtejn il- buttuna tad- dożaġġ u lanqas il- ħoss ta ’ madwar 15- il sekonda wara 4 minuti, IONSYS għandu jiġi rritornat lill- manifattur fil- pakkett intatt.
Do not open the sachet and do not dispense such an IONSYS system to a patient.
Tiftaħx il- pakkett u tagħtix din is- sistema IONSYS lill- pazjent.
Contact with the fentanyl hydrogel can be harmful to humans.
Kuntatt ma ’ fentanyl hydrogel jista ’ jkun ta ’ periklu għall- bnedmin.
Medical staff and patients should handle the used system carefully and only by the sides and top housing.
Staff mediku u pazjenti għandhom imissu s- sistema użata b’ attenzjoni u jmissuha biss mill- ġnub u mill- għata ta ’ fuq.
The design of the system allows separate disposal of the red fentanyl-containing bottom housing and the white electronic/ battery containing top housing.
Il- mod kif ġiet diżenjata s- sistema tippermetti illi jkun hemm rimi separat tal- parti ħamra ta ’ isfel li fiha l - fentanyl u l- parti bajda elettronika ta ’ fuq li fiha l- batterija.
To dispose of a used IONSYS system:
Biex tarmi s- sistema wżata IONSYS:
Pull the red tab to separate the bottom housing from the top housing.
Iġbed id- dendul aħmar biex tissepara l- parti ta ’ isfel tal- għata mill- parti ta ’ fuq tal- għata.
Fold the bottom gel-containing housing in half with the sticky side facing in.
Itwi minn- nofs il- parti t’ isfel li fiha l- ġell bill- parti li twaħħal tħares il- ġewwa.
Dispose of bottom housing in accordance with local legislation for opioid medicinal products.
Armi l- parti t’ isfel skond leġislazzjoni lokali għal prodotti mediċinali opioid.
The used bottom housing of IONSYS contains a dangerous amount of fentanyl.
Il- parti t’ isfel tal - għata ta ’ IONSYS użat jikkontjeni ammont perikoluż ta ’ fentanyl.
Dispose of top housing, containing electronics, according to local procedures for battery waste.
Armi l- parti ta ’ fuq tal- għata, li fiha l- elettronika, skond proċeduri lokali għal rimi ta ’ batteriji.
Local arrangements should be in place to ensure that used systems are returned appropriately (e. g. to hospital pharmacies) for disposal of the residual fentanyl in the hydrogel and will be disposed according to local legal requirements.
Għandu jkun hemm arranġamenti lokali sabiex jiżguraw li sistemi wżati jiġu rritornati kif suppost (p. e. l- ispiżeriji tal- isptar) għar- rimi ta ’ fentanyl li jifdal fil- hydrogel u dan jintrema skond kif jitolbu l - liġijiet lokali.
Date of first authorisation:
L- ewwel awtorizzazzjoni:
24 January 2006.
24 ta ’ Jannar 2006
12 10.
12 ANNESS II
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
CONDITIONS OF THE MARKETING AUTHORISATION
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott.
Medicinal product subject to special and restricted medical prescription (See Annex I:
Prodott mediċinali jingħata b' riċetta speċjali u ristretta tat- tabib (Ara Anness I:
The Marketing Authorisation Holder must implement nationally, prior to marketing, and as agreed with the competent authorities in the Member States:
Kif miftiehem mal- awtoritajiet kompetenti fl- Istati Membri, qabel ma jitqiegħed fuq is - suq, id- Detentur tal- Awtorizzazzjoni tal- Manifattura għandu jimplimenta b’ mod nazzjonali:
• An educational plan for physicians and health care providers, which is aimed at risk minimisation and to support safe and effective use for the product.
• Pjan edukattiv għal tobba u fornituri tal- kura tas- saħħa, li l- iskop tiegħu jkun biex inaqqas r- riskju u sabiex jappoġġa użu mingħajr periklu u effettiv tal- prodott.
This plan should address the following:
Dan il- pjan għandu jindirizza s- segwenti:
Overdose/ underdose Accidental exposure Misuse/ abuse/ diversion Mechanical failures Use in patients with a history of drug abuse Disposal according with the local legal requirements
Doża eċċessiva / doża inqas milli suppost Esponiment aċċidentali Użu żbaljat / abbuż / żvijar Fallimenti mekkaniċi Użu f’ pazjenti b’ passat ta ’ abbuż ta ’ droga Rimi skond kif jitolbu l- liġijiet lokali
• An educational plan for patients, which is aimed at risk minimisation and to support safe and effective use for the product.
• Pjan edukattiv għal pazjenti, immirat sabiex jimminimizza r- riskju u sabiex jappoġġa użu sikur u effettiv tal- prodott.
Training for the patients will be via a healthcare professional.
Taħriġ tal- pazjenti jsir permezz ta ’ professjonista fil- kura tas- saħħa.
Overdose/ underdose Accidental exposure Misuse/ abuse/ diversion Mechanical failures Disposal according with the local legal requirements
Doża eċċessiva / doża inqas milli suppost Espożizzjoni aċċidentali Użu żbaljat / abbuż / żvijar Fallimenti mekkaniċi Rimi skond rekwiżiti legali lokali
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market.
Il- MAH għandu jiżgura li s- sistema ta ’ farmakoviġilanza qiegħda f’ posta u taħdem qabel ma ’ l- prodott jitqiegħed fuq is- suq.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq (MAH) jobbliga ruħu li jagħmel studji u attivitajiet ta ’ farmakoviġilanza addizzjonali kif dettaljati fil- Pjan ta ’ Farmakoviġilanza.
15 An updated Risk Management Plan, as per the CHMP Guideline on Risk Management Systems for medicinal products for human use, should be submitted at the same time as the PSURs, within 60 days of an important (Pharmacovigilance or Risk minimisation) milestone being reached or when the results of a study becoming available or at the request of the Competent authority.
14 Pjan aġġornat tal- Maneġġjar tar- Riskju, skond il- linji gwida CHMP fuq Sistemi ta ’ Maneġġjar ta ’ Riskju f’ prodotti mediċinali għall- użu fil- bniedem, għandhom jiġu sottomessi fl- istess żmien tal - PSURs, fi żmien 60 jum minn meta tintlaħaq mira (Farmakoviġilanza jew Minimizzazzajoni tar - Riskju) importanti jew meta r- riżultati ta ’ studju jiġu disponibbli jew fuq rikjesta tal- Awtorità Kompetenti.
LABELLING
17 TAGĦRIF LI GĦANDU JIDHER FUQ < IL- PAKKETT TA ’ BARRA > < U > < IL- PAKKETT LI JMISS MAL- PRODOTT >
CARDBOARD CARTON
KARTUNA
IONSYS 40 micrograms per dose iontophoretic transdermal system Fentanyl
IONSYS 40 mikrogramma għal kull doża ta ’ sistema jontoforetika li tipprovdi mediċina li tgħaddi minn ġol- ġilda
Each system delivers 40 micrograms fentanyl per 10 minutes dose, to a maximum of 3.2 mg (80 doses).
Kull sistema tgħaddi 40 mikrogramma fentanyl għal kull doża ta ’ 10 minuti, għal massimu ta ’ 3. 2mg (80 doża).
Each system contains 10.8 mg fentanyl hydrochloride equivalent to 9.7 mg of fentanyl.
Kull sistema fiha 10. 8mg fentanyl hydrochloride ekwivalenti għal 9. 7mg ta ’ fentanyl.
- cathode hydrogel: sodium citrate, polyvinyl alcohol, anhydrous citric acid, cetylpyridinium
- hydrogel katodiku: sodium citrate, polyvinyl alcohol, anhydrous citric acid, cetypyridinium
chloride, purified water and sodium chloride.
chloride, ilma ppurifikat u sodium chloride.
- anode electrode: silver foil and electrically conductive adhesive tape (ECAT)
- elettrodu anodiku: fojl tal- fidda u tejp adeżiv li jikkonduċi l- elettriku (ECAT)
- cathode electrode: trilaminate of silver chloride composite material, silver foil, ECAT
- elettrodu katodiku: tliet safef ta ’ materjal kompost ta ’ silver chloride, fojl tal- fidda, ECAT
- skin adhesive: polybutene, resin ester
- adeżiv tal- ġilda: polybutene, ester tar- reżina.
Iontophoretic transdermal system (ITS); one system + moisture absorber
Sistema jontoforetika li tipprovdi mediċina li tgħaddi minn ġol- ġilda (ITS); sistema waħda + assorbent tal- umidità.
For hospital use only
Għal użu fl- isptar biss.
Use immediately after opening
Użah immedjatament wara li tiftaħ.
19 DO NOT USE IF SEAL ON SACHET IS BROKEN OR IF MOISTURE ABSORBER IS MISSING OR NOT INTACT
18 TUŻAX JEKK IS- SIĠILL FUQ IL- QARTAS HUWA MKISSER JEW JEKK L- ASSORBENT TAL - UMIDITÀ HUWA NIEQES JEW MHUX INTATT
For further information, read the enclosed leaflet.
Għal iktar informazzjoni ara l- fuljett mehmuż.
EXP {MM/ YYYY}
SKAD {XX/ SSSS}
Store in the original package
Aħżen fil- pakkett oriġinali
A potentially dangerous amount of fentanyl remains in the system after use.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN.
See package leaflet for disposal information
Ara l- fuljett ta ’ tagħrif għal informazzjoni dwar kif jintrema.
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, Belgium
Janssen- Cilag International NV Turnhoutseweg 30, B- 2340 Beerse, Il- Belġju
Medicinal product subject to special and restricted medical prescription.
Prodott mediċinali jingħata bir- riċetta speċjali u ristretta tat- tabib
ALUMINIUM FOIL SACHET
QARTAS TAL- FOJL TAL- ALUMINJU
Contains 10.8 mg fentanyl hydrochloride equivalent to 9.7 mg of fentanyl Transdermal use.
Fih 10. 8mg fentanyl hydrochloride ekwivalenti għal 9. 7mg ta ’ fentanyl Użu transdermali.
Read the package leaflet before use.
Ara l- fuljett ta ’ tagħrif qabel l- użu.
< EXP {MM/ YYYY}
SKAD {XX/ SSSS}
One system + moisture absorber
Sistema waħda + assorbent tal- umidità.
Test system before opening sachet – see enclosed leaflet.
Ittestja s- sistema qabel ma tiftaħ il- qartas – ara fuljett mehmuż.
To open, tear carefully starting from the pre-cut notch.
Biex tiftaħ, qatta ’ bil- mod minn fejn hemm ix- xaqq diġa maqtugħ.
Use immediately after opening.
Uża immedjatament wara li tiftaħ.
Do not use if moisture absorber is missing or not intact.
Tużaħx jekk l- assorbent tal- umidità huwa nieqes jew mhux intatt.
A potentially dangerous amount of fentanyl remains in the system after use.
Ammont potenzjalment perikoluż ta ’ fentanyl jibqa ’ fis- sistema wara l- użu
PACKAGE LEAFLET
21 FULJETT TA ’ TAGĦRIF:
IONSYS 40 micrograms per dose iontophoretic transdermal system fentanyl
IONSYS 40 mikrogramma għal kull doża ta ’ sistema jontoforetika li tipprovdi mediċina li tgħaddi minn ġol- ġilda fentanyl
- If you have any further questions, please ask your doctor or your nurse.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- infermier tiegħek.
- This product has been prescribed for you.
- Din il- mediċina ġiet mogħtija lilek.
- If any of the side-effects gets serious, or if you notice any side effects not listed in this leaflet,
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
please tell your doctor or nurse.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- infermier tiegħek.
What IONSYS is and what it is used for 2.
X’ inhu IONSYS u għalxiex jintuża 2.
Before you use IONSYS 3.
Qabel ma tuża IONSYS 3.
How to use IONSYS 4.
Kif għandek tuża IONSYS 4.
Possible side effects 5.
Effetti sekondarji li jista ’’ jkollu 5.
How to store IONSYS 6.
Kif taħżen IONSYS 6.
WHAT IONSYS IS AND WHAT IT IS USED FOR
X’ INHU IONSYS U GĦALXIEX JINTUŻA
IONSYS is a system that you can operate to control your pain.
IONSYS huwa sistema li tista topera sabiex tikkontrolla l- uġigħ.
IONSYS is used in hospital only, to treat pain after an operation.
IONSYS jintuża l- isptar biss, sabiex jitratta uġigħ wara xi operazzjoni.
You control your own treatment, under the guidance of medical staff.
Inti tikkontrolla t- trattament tiegħek, taħt il- gwida tal- istaff mediku.
BEFORE YOU USE IONSYS
QABEL MA TUŻA IONSYS
Do not use IONSYS:
Tużax IONSYS:
- If you are allergic (hypersensitive) to fentanyl, adhesive bandages or tapes, or any of the
- Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal fentanyl, faxex adeżivi jew tejp, jew
ingredients listed below.
xi ingredjenti oħra mikruba hawn taħt.
Take special care with IONSYS Tell your doctor or nurse
Għid lit- tabib jew lill- infermier tiegħek
- If you already have problems with your lungs or trouble breathing
- Jekk inti għandek problemi fil- pulmun jew tbati biex tieħu n- nifs
- If you have problems with your heart, liver or kidneys
- Jekk inti għandek problemi b’ qalbek, bil- fwied jew kliewi
- If you get headaches or have had a head injury
- Jekk ikollok uġigħ ta ’ ras jew jekk kellek xi ferita f’ rasek
- If you have any difficulty hearing
- Jekk għandek problemi ta ’ smiegħ
- If you have abnormally slow bowel movements
- Jekk għandek ċaqliq tal- imsaren bil- mod b’ mod anormali
Taking other medicines Some medicines can affect the way IONSYS works, or make it more likely that you’ ll have side effects.
Ċerti mediċini jistgħu jaffettwaw il- mod kif jaħdem IONSYS, jew iżidu l- possibilità li jkollok effetti mhux mixtieqa.
Check with your doctor if you’ re taking:
Staqsi lit- tabib jekk qed tieħu:
- any medicine which makes you sleepy or drowsy (such as other morphine-related painkillers,
- xi mediċina li traqqdek jew tħeddlek (bħal mediċini kontra l- uġigħ relatati mal- morfina,
antihistamines or tranquillisers)
antistamini jew kalmanti)
- muscle relaxants (these may be prescribed for back pain)
- rilassanti tal- muskoli (dawn jistgħu jingħataw għal uġigħ fid- dahar)