qanastek/EMEA-V3 huggingface dataset:
Methylnaltrexone bromide-treated patients had a significantly higher rate of laxation within 4 hours of the double-blind dose (62% for 0.15 mg/ kg and 58% for 0.3 mg/ kg) than placebo-treated patients (14%); p < 0.0001 for each dose versus placebo.
L- ewwel punt ta ’ riferiment aħħari kien il- proporzjon ta ’ pazjenti b’ rescue- free laxation fi żmien 4 sigħat miż- żmien tad- doża double blind tal- prodott mediċinali methylnaltrexone bromide kellhom rata ta ’ ippurgar ogħla b’ mod sinifikanti fi żmien 4 sigħat tad - doża double- blind (62% għal 0. 15 mg/ kg u 58% għal 0. 3 mg/ kg) mill- pazjenti kkurati bil- plaċebo (14%); p < 0. 0001 għal kull doża kontra l- plaċebo
During the first week (days 1, 3, 5, 7), patients received either
L- istudju 302 ipparaguna dożi double blind li jingħataw taħt il- ġilda ta ’ methylnaltrexone bromide li ngħataw ġurnata iva u ġurnata le għal ġimgħatejn mal- plaċebo.
5 methylnaltrexone bromide 0.15 mg/ kg or placebo.
Matul l- ewwel ġimgħa (jiem 1, 3, 5, 7), il- pazjenti rċevew 0. 15 mg/ kg methylnaltrexone bromide jew plaċebo.
In the second week, a patient’ s assigned dose could be increased to 0.30 mg/ kg if the patient had 2 or fewer rescue-free laxations up to day 8.
Fit- tieni ġimgħa, id- doża assenjata lill- pazjent setgħat togħla għal 0. 30 mg/ kg jekk il- pazjent kellu 2 rescue- free laxations jew inqas sat- 8 jum.
Data from 133 (62 methylnaltrexone bromide, 71 placebo) patients were analysed.
Tagħrif minn 133 (62 methylnaltrexone bromide, 71 plaċebo) pazjent ġew analizzati.
There were 2 primary endpoints: proportion of patients with a rescue-free laxation within 4 hours of the first dose of study medicinal product and proportion of patients with a rescue-free laxation within 4 hours after at least 2 of the first 4 doses of medicinal product.
Kien hemm żewġ punti primarji ta ’ riferiment aħħarija: il- proporzjon ta ’ pazjenti b’ rescue free laxation fi żmien 4 sigħat mill- ewwel doża tal- prodott mediċinali li qed jiġi studjat u l- proporzjon ta ’ pazjenti b’ rescue- free laxation fi żmien 4 sigħat wara ta ’ lanqas 2 mill- ewwel 4 dożi tal- prodott mediċinali.
Methylnaltrexone bromide-treated patients had a higher rate of laxation within 4 hours of the first dose (48%) than placebo-treated patients (16%); p < 0.0001.
Pazjenti trattati b ’ methylnaltrexone bromide kellhom rata ogħla ta ’ ippurgar fi żmien 4 sigħat mill- ewwel doża (48%) mill- pazjenti li kienu qed jieħdu l- plaċebo (16%); p < 0. 0001 (Figura 1).
Methylnaltrexone bromide-treated patients also had significantly higher rates of laxation within 4 hours after at least 2 of the first 4 doses (52%) than did placebo-treated patients (9%); p < 0.0001.
Pazjenti trattati b ’ methylnaltrexone bromide ukoll kellhom rati ta ’ ippurgar ogħla b’ mod sinifikanti fi żmien 4 sigħat wara ta ’ lanqas 2 mill- ewwel 4 dożi (52%) milli kellhom pazjenti trattati bi plaċebo (9%); p < 0. 0001.
Stool consistency was not meaningfully improved in patients who had soft stool at baseline.
Il- konsistenza ta ’ l- ippurgar ma kienitx imtejba ħafna f’ pazjenti li kellhom ippurgar artab mall- linja bażi.
In both studies, there was no evidence to suggest differential effects of age or gender on safety or efficacy.
Fiż- żewġ studji, ma kien hemm l- ebda evidenza li tissuġerixxi effetti differenti minħabba età jew sess fuq is- sigurtà jew l- effikaċja.
The effect on race could not be analysed because the study population was predominantly Caucasian (88%)
L- effett fuq ir- razza ma setax jiġi analizzat peress li l- popolazzjoni studjata kienet prinċipalment Kawkasi (88%).
Durability of response was demonstrated in Study 302, in which the laxation response rate was consistent from dose 1 through dose 7 over the course of the 2-week, double-blind period
It- tul tar- rispons kien muri fi Studju 302, fejn ir- rata ta ’ rispons ta ’ ippurgar kienet konsistenti mill- 1 doża sa doża 7 waqt il- perijodu double- blind ta ’ ġimagħtejn.
The efficacy and safety of methylnaltrexone bromide were also demonstrated in open-label treatment administered from Day 2 through Week 4 in Study 301, and in two open-label extension studies (301EXT and 302EXT) in which methylnaltrexone bromide was given as needed for up to 4 months (only 8 patients up to this point).
L- effikaċja u s- sigurtà ta ’ methylnaltrexone bromide kienu murija wkoll fi trattament open label mogħti minn Jum 2 sa Ġimgħa 4 fi Studju 301, u f’ żewġ studji ta ’ estensjoni b’ open label (301EXT u 302EXT) meta methylnaltrexone bromide ngħata kif meħtieġ għal sa 4 xhur (s’ issa 8 pazjenti biss).
A total of 136, 21, and 82 patients received at least one open-label dose in studies 301, 301EXT, and 302EXT, respectively.
Total ta ’ 136, 21, u 82 pazjent irċevew minn ta ’ lanqas doża waħda open label fl- istudji 301, 301EXT, u 302EXT, rispettivament.
RELISTOR was administered every 3.2 days (median dosing interval, with a range of 1-39 days).
RELISTOR kien mogħti kull 3. 2 jiem (intervall ta ’ doża medjana fuq medda ta ’ 1- 39 jum).
The rate of laxation response was maintained throughout the extension studies for those patients who continued treatment.
Ir- rata ta ’ rispons purganti inżammet matul l- istudji ta ’ estensjoni għal dawk il- pazjenti li baqgħu jieħdu trattament.
There was no significant relationship between baseline opioid dose and laxation response in methylnaltrexone bromide-treated patients in these studies.
6 Ma kien hemm ebda relazzjoni sinifikanti bejn id- doża ta ’ opjojdi mal- linja bażi u r- rispons purganti f’ pazjenti trattati b’ methylnaltrexone bromide f’ dawn l- istudji.
In addition, median daily opioid dose did not vary meaningfully from baseline in either methylnaltrexone bromide-treated patients or in placebo-treated patients.
Minbarra hekk, id- doża medjana ta ’ kuljum ma varjatx b’ mod sinifikanti mill- linja bażi ta ’ riferiment kemm f’ pazjenti trattati b’ RELISTOR jew f’ pazjenti trattati bi plaċebo.
There were no clinically relevant changes in pain scores from baseline in either the methylnaltrexone bromide or placebo-treated patients.
Ma kien hemm ebda bidliet klinikament rilevanti fil- punteġġi ta ’ l- uġigħ mill- punt ta ’ riferiment kemm f’ pazjenti trattati b’ methynaltrxone jew pazjenti trattati bi plaċebo.
Effect on cardiac repolarisation In a double-blind, randomised, parallel-group ECG study of single, subcutaneous doses of methylnaltrexone bromide (0.15, 0.30 and 0.50 mg/ kg), in 207 healthy volunteers, no signal of QT/ QTc prolongation or any evidence of an effect on secondary ECG parameters or waveform morphology was detected as compared to placebo and a positive control (orally administered 400 mg moxifloxacin).
Effett fuq ir- ripolarizzazzjoni kardijaka Fi studju double- blind, randomized ta ’ l- ECG fuq grupp parallel f’ 207 voluntier b’ saħħtu, li ngħataw doża waħda taħt il- ġilda ta ’ methylnaltrexone bromide (0. 15, 0. 30 u 0. 50 mg/ kg), ma kien hemm ebda sinjal ta ’ titwil ta ’ QT/ QTc jew evidenza oħra fuq parametri sekondarji ta ’ l- ECG jew morfoloġija fuq il- waveform ma ġie indikat meta mqabbel ma ’ plaċebo jew kontroll pożittiv (400 mg moxifloxacin mogħti mill- ħalq).
Absorption Methylnaltrexone bromide is absorbed rapidly, with peak concentrations (Cmax) achieved at approximately 0.5 hours following subcutaneous administration.
Assorbiment Methylnaltrexone jiġi assorbit malajr, bl- ogħla konċentrazzjonijiet (Cmax) jintlaħqu madwar 0. 5 sigħat wara l - għoti taħt il- ġilda.
The Cmax and area under the plasma concentration-time curve (AUC) increase with dose increase from 0.15 mg/ kg to 0.5 mg/ kg in a dose- proportional manner.
Cmax u l- erja taħt il- kurva tal- konċentrazzjoni tal- plażma mal- ħin (AUC) tiżdied maż- żieda fid - doża minn 0. 15 mg/ kg sa 0. 5 mg/ kg b’ mod proporzjonali mad- doża.
Absolute bioavailability of a 0.30 mg/ kg subcutaneous dose versus a 0.30 mg/ kg intravenous dose is 82%.
Il- bijodisponibilità assoluta ta ’ doża taħt il - ġilda ta ’ 0. 30 mg/ kg kontra doża ta ’ 0. 30 mg/ kg li tingħata ġol- vina hija ta ’ 82%.
Distribution Methylnaltrexone undergoes moderate tissue distribution.
Firxa Methylnaltrexone ikollu firxa moderata fit- tessuti.
The steady-state volume of distribution (Vss) is approximately 1.1 l/ kg.
L- istat fiss ta ’ volum ta ’ distribuzzjoni (Vss) huwa madwar 1. 1 l/ kg.
Methylnaltrexone is minimally bound to human plasma proteins (11.0% to 15.3%) as determined by equilibrium dialysis.
Methylnaltrexone jintrabat mill- inqas mal- proteini tal- plażma tal- bniedem (11. 0% sa 15. 3%) kif stabbilit b’ dijaliżi ta ’ ekwilibriju.
6 Metabolism Methylnaltrexone is metabolised to a modest extent in humans based on the amount of methylnaltrexone metabolites recovered from excreta.
Metaboliżmu Methylnaltrexone huwa metabolizzat b’ mod modest fil- bniedem skond l- ammont ta ’ metaboli ta ’ methylnaltrexone rkuprati mill- ippurgar.
Conversion to methyl-6-naltrexol isomers and methylnaltrexone sulphate appears to be the primary pathway to metabolism.
Il- konverżjoni għal iżomeri ta ’ methyl- 6- naltrexol u methylnaltrexone sulphate jidher li huwa l- passaġġ primarju għal metaboliżmu.
Each of the methyl-6- naltrexol isomers has somewhat less antagonist activity than parent compound, and a low exposure in plasma of approximately 8% of the drug-related materials.
Kull wieħed mill- iżomeri ta ’ methyl- 6- naltrexol għandu kemmxejn anqas attività antagonista mill- kompost ġenitur, u espożizzjoni baxxa fil- plażma ta ’ madwar 8% tal- materjal relatat mal- mediċina.
Methylnaltrexone sulphate is an inactive metabolite and present in plasma at a level of approximately 25% of drug related materials.
Methynaltrexone sulphate huwa metabolu mhux attiv u preżenti fil - plażma f’ livell ta ’ madwar 25% ta ’ materjal relatat mal- mediċina.
N- demethylation of methylnaltrexone to produce naltrexone is not significant, accounting for 0.06% of the administered dose.
N- demethylation ta ’ methylnaltrexone sabiex jipproduċu naltrexone mhux sinifikanti, li jgħodd għal 0. 06% tad- doża mogħtija.
Excretion Methylnaltrexone is eliminated primarily as the unchanged active substance.
Eskrezzjoni Methylnaltrexone jiġi eliminat l- aktar bħala s- sustanza attiva mhux mibdula.
Approximately half of the dose is excreted in the urine and somewhat less in faeces.
Madwar nofs id- doża tiġi eliminata fl- awrina u ftit inqas fl- ippurgar.
The terminal disposition half-life (t1/ 2) is approximately 8 hours.
Il- half- life terminali ta ’ dispożizzjoni (t1/ 2) hija ta ’ madwar 8 sigħat.
Hepatic insufficiency The effect of mild and moderate hepatic impairment on the systemic exposure to methylnaltrexone has been studied in 8 subjects each, with Child-Pugh Class A and B, compared to healthy subjects.
Insuffiċjenza epatika L- effett ta ’ indeboliment epatiku ħafif u moderat fuq l- espożizzjoni sistematika ta ’ methylnaltrexone ġie studjat fi 8 individwi kull wieħed minnhom, b’ Child- Pugh ta ’ Klassi A u B, imqabblin ma ’ individwi b’ saħħithom.
Results showed no meaningful effect of hepatic impairment on the AUC or Cmax of methylnaltrexone.
Ir - riżultati ma wrew ebda effett sinifikanti ta ’ indeboliment epatiku fuq l- AUC jew Cmax ta ’ methylnaltrexone.
The effect of severe hepatic impairment on the pharmacokinetics of methylnaltrexone has not been studied.
L - effett ta ’ indeboliment epatiku sever fuq il- farmakokinetika ta ’ methylnaltrexone ma ġiex studjat.
Renal insufficiency In a study of volunteers with varying degrees of renal impairment receiving a single dose of 0.30 mg/ kg methylnaltrexone bromide, renal impairment had a marked effect on the renal excretion of methylnaltrexone.
Inuffiċjenza renali Fi studju ta ’ voluntieri bi gradi differenti ta ’ indeboliment renali li rċevew doża waħda ta ’ 0. 30 mg/ kg methylnaltrexone bromide, l- indeboliment renali kellu effett notevoli fuq l- eliminazzjoni mill- kliewi ta ’ methylnaltrexone.
The renal clearance of methylnaltrexone decreased with increasing severity of renal impairment.
It- tneħħija mill- kliewi ta ’ methylnaltrexone tnaqqset b’ żieda fis- severità ta ’ l- indeboliment renali.
Severe renal impairment decreased the renal clearance of methylnaltrexone by 8- to 9-fold; however, this resulted in only a 2-fold increase in total methylnaltrexone exposure (AUC).
L- indeboliment renali sever naqqas it- tneħħija ta ’ methylnaltrexone bi 8 sa 9 darbiet; madankollu dan 7 irriżulta f’ żieda ta ’ darbtejn fl- espożizzjoni totali għal methylnaltrexone (AUC).
Cmax was not significantly changed.
Cmax ma kienx mibdul b’ mod sinifikanti.
No studies were performed in patients with end-stage renal impairment requiring dialysis.
L- ebda studju ma ġie mwettaq f’ pazjenti b’ indeboliment renali ta ’ l- aħħar stadju li kienu jeħtieġu d - dijaliżi.
Paediatric patients No studies have been performed in the paediatric population (see section 4.2).
Pazjenti tfal L- ebda studju ma ġie mwettaq fil- popolazzjoni ta ’ tfal (ara sezzjoni 4. 2).
Elderly patients In a study comparing single and multiple-dose pharmacokinetic profiles of intravenous methylnaltrexone at a dose of 24 mg between healthy, young (18 to 45 years of age n=10) and elderly (65 years of age and over n=10) subjects, the effect of age on exposure to methylnaltrexone was found to be minor.
Pazjenti anzjani Fi studju li qabbel profili farmakokinetiċi ta ’ dożi waħdanin u multipli ta ’ methylnaltrexone mogħti ġol- vina f’ doża ta ’ 24 mg bejn individwi b’ saħħithom, żgħar (18 sa 45 sena n=10) u anzjani (65 sena u aktar u n=10), l- effett ta ’ l- età għall- espożizzjoni ta ’ methylnaltrexone instab li hu minuri.
The mean steady-state Cmax and AUC for the elderly were 545 ng/ ml and 412 ng·h/ ml, approximately 8.1% and 20%, respectively, greater than those for young subjects.
L- istat fiss medju Cmax u AUC għall- anzjani kienu 545 ng/ ml u 412 ng· h/ ml, madwar 8. 1% u 20%, rispettivament ogħla minn dawk individwi żgħażagħ.
Therefore, no dose adjustment is recommended based on age.
Għalhekk, l- ebda aġġustament għad- doża minħabba l- età mhu rakkomandat.
Gender No meaningful gender differences have been observed.
Sess L- ebda differenza notevoli minħabba s- sess ma ġiet osservata.
Weight An integrated analysis of pharmacokinetic data from healthy subjects indicated that methylnaltrexone mg/ kg dose-adjusted exposure increased as body weight increased.
Piż Analiżi integrata ta ’ tagħrif farmakokinetiku minn individwi b’ saħħithom indikat li l- espożizzjoni aġġustata għad- doża ta ’ methylnaltrexone mg/ kg żdidet ma ’ żieda fil- piż tal- ġisem.
The mean methylnaltrexone exposure at 0.15 mg/ kg over a weight range of 38 to 114 kg was 179 (range=139-240) ng. h/ ml.
L- espożizzjoni medja għal methylnaltrexone f’ doża ta ’ 0. 15 mg/ kg fuq firxa ta ’ piżijiet ta ’ bejn 38 sa 114 kg kienet ta ’ 179 (firxa ta ’ =139- 240) ng. h / ml.
This exposure for the 0.15 mg/ kg dose can be achieved with a weight-band-based dose adjustment using an 8 mg dose for body weight 38 to less than 62 kg and a 12 mg dose for body weight 62 to 114 kg, yielding a mean exposure of 187 (range =148-220) ng. h/ ml.
Din l- espożizzjoni għad- doża ta ’ 0. 15 mg/ kg tista ’ tintlaħaq b’ faxxa ta ’ piżijiet ibbażati skond l- aġġustament tad- doża billi tintuża doża ta ’ 8 mg għal piż tal- ġisem ta ’ 38 sa inqas minn 62 kg u doża ta ’ 12 mg għal piż tal- ġisem ta ’ 62 sa 114 kg, li jrendi espożizzjoni medja ta ’ 187 (firxa =148- 220) ng. h / mL.
In addition, the analysis showed that 8 mg dose for body weight 38 to less than 62 kg and a 12 mg dose for body weight 62 to 114 kg correspond to mean doses of 0.16 (range=0.21-0.13) mg/ kg and 0.16 (range=0.19-0.11) mg/ kg, respectively, based on the body weight distribution of patients participating in studies 301 and 302.
Minbarra hekk, l- analiżi wriet li doża ta ’ 8 mg għal piż tal- ġisem ta ’ 38 sa inqas minn 62 kg u doża ta ’ 12 mg għal piż tal- ġisem ta ’ 62 sa 114 kg jikkorispondu għal dożi medji ta ’ 0. 16 (firxa=0. 21- 0. 13) mg/ kg u 0. 16 (firxa=0. 19- 0. 11) mg/ kg, rispettivament, skond id- distribuzzjoni tal- piż tal- ġisem ta ’ pazjenti li pparteċipaw fl- istudji 301 u 302.
7 5.3 Preclinical safety data
5. 3 Tagħrif ta 'qabel l- użu kliniku
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, and genotoxicity.
Informazzjoni li mhix klinika ma tirrivela ebda periklu speċjali għal bniedem, fuq bażi ta ’ studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti u effett tossiku fuq il- ġeni.
Cardiac effects were observed in some non- clinical studies in canines (prolongation of action potentials in Purkinje fibers or prolongation of the QTc interval).
Effetti kardjovaskulari kienu osservati fi studji mhux kliniċi fil- klieb (titwil tal- potenzjal t’ azzjoni fil- fibri Purkinje jew titwil fl - intervall QTc).
The mechanism of this effect is unknown; however, the human cardiac potassium ion channel (hERG) appears not to be involved.
Il- mekkaniżmu ta ’ dan l- effett mhux magħruf; madankollu l- kanal kardijaku uman għall- ijoni tal - potassium (hERG) ma jidhirx li hu involut.
Subcutaneous injections of RELISTOR at 150 mg/ kg/ day decreased fertility in rats.
Injezzjoni taħt il- ġilda ta ’ RELISTOR f’ doża ta ’ 150 mg/ kg/ jum naqset il- fertilità fil- firien.
Doses up to 25 mg/ kg/ day (18 times the exposure [AUC] in humans at a subcutaneous dose of 0.3 mg/ kg) did not affect fertility or general reproductive performance.
Dożi sa 25 mg/ kg/ jum (18- il darba aktar l- espożizzjoni [AUC] għal bniedem f’ doża ta ’ 0. 3 mg/ kg li tingħata taħt il- ġilda) ma affettwatx il- fertilità jew il- prestazzjoni riproduttiva ġenerali.
There was no evidence of teratogenicity in rats or rabbits.
Ma kien hemm ebda evidenza ta ’ teratoġeniċità fil- firien jew fil- fniek.
Subcutaneous injections of RELISTOR at 150/ 100 mg/ kg/ day to rats resulted in decreased offspring weights; doses up to 25 mg/ kg/ day (18 times the exposure [AUC] in humans at a subcutaneous dose of 0.3 mg/ kg) had no effect on labour, delivery, or offspring survival and growth.
Injezzjonijiet taħt il- ġilda ta ’ RELISTOR f’ dożi ta ’ 150/ 100 mg/ kg/ kuljum għal firien irriżultaw f’ piżijiet mnaqqsa tal- ġriewi; dożi ta ’ 25 mg/ kg/ jum (18- il darba l- espożizzjoni [AUC] fil- bniedem f’ doża ta ’ 0. 3 mg/ kg li tigħata taħt il- ġilda) ma kellhom ebda effett fuq il- ħlas, it- twelid, jew is- sopravivenza tal- wild u l- iżvilupp.
Methylnaltrexone bromide is excreted via the milk of lactating rats.
Methylnaltrexone bromide huwa eliminat fil- ħalib ta ’ firien li qed ireddgħu.
Carcinogenicity studies have not been conducted with RELISTOR.
Ma sarux studji dwar il- karċinoġeniċità b’ RELISTOR.
Sodium chloride Sodium calcium edetate Glycine hydrochloride Water for injections Hydrochloric acid (to adjust pH) Sodium hydroxide (to adjust pH)
Sodium chloride Sodium calcium edetate Glycine hydrochloride Ilma għall- injezzjonijiet Hydrochloric acid (biex taġġusta l- pH) Sodium hydroxide (biex taġġusta l- pH)
After withdrawl in the injection syringe:
Wara t- tneħħija tas- siringa ta ’ l- injezzjoni:
Due to light sensitivity, the solution for injection should be used within 24 hours.
Minħabba sensittività għad- dawl, is- soluzzjoni għall- injezzjoni għandha tintuża fi żmien 24 siegħa.
Store below 30ºC.
Aħżen f’ temperatura taħt 30ºC.
For storage of the medicinal product in the syringe, see section 6.3.
Għall- ħażna tal- prodott mediċinali fis- siringa, ara sezzjoni 6. 3.
6.5 Nature and contents of container
9 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Clear, Type I, flint glass, single-use vial, grey butyl rubber stopper, and aluminium overseal with flip-off-cap.
Kunjett ċar, Tip I, bi ħġieġ taż- żnied, kunjett li jintuża darba biss, b’ tapp griż tal- lastku tal- butyl, u siġill ta ’ l - aluminium b’ għatu li jinqala ’ bis- saba ’.
8 Each vial contains 0.6 ml of solution for injection.
Kull kunjett fih 0. 6 ml ta ’ soluzzjoni għall- injezzjoni.
The presentations of RELISTOR are:
RELISTOR issibu bħala:
1 vial of solution for injection
Kunjett 1 b’ soluzzjoni għall- injezzjoni
2 vials of solution for injection 2 sterile 1 ml injection syringes with retractable injection needle 4 alcohol swabs
2 kunjetti b’ soluzzjoni għall- injezzjoni 2 siringi ta ’ l- injezzjoni sterili ta ’ 1 ml b’ labra ta ’ l- injezzjoni li tinġibed lura 4 ġbajjar ta ’ l- alkoħol
7 vials of solution for injection 7 sterile 1 ml injection syringes with retractable injection needle 14 alcohol swabs
7 kunjetti għal soluzzjoni għall- injezzjoni 7 siringi ta ’ l- injezzjoni sterili ta ’ 1 ml b’ labra ta ’ l- injezzjoni li tinġibed lura 14 ġbajjar ta ’ l- alkoħol
Wyeth Europa Limited Huntercombe Lane South Taplow, Maidenhead Berkshire SL6 OPH United Kingdom Tel:
Wyeth Europa Limited Huntercombe Lane South Taplow, Maidenhead Berkshire SL6 OPH Ir- Renju Unit Tel:
Name and address of the manufacturer responsible for batch release
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Via Franco Gorgone Zona Industriale IT-95030 Catania Italy
Via Franco Gorgone Zona Industriale IT- 95030 Catania L- Italja
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.2 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid dis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza deskritta f’ verżjoni 1. 2 ippreżentata f’ Modulu 1. 8. 1. ta ’ l- Applikazzjoni għal Awtorizzazzjoni għat- Tqegħid fis - Suq, hija f’ postha u qed tiffunzjona minn qabel u waqt li l- prodott ikun fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.2 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan ta ’ l- Immaniġġar tar- Riskju L- MAH jimpenja ruħu li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza addizzjonali dettaljati fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni 1. 2 tal- Pjan ta ’ l- Immaniġġar tar- Riskju (RMP) ippreżentata fil- Modolu 1. 8. 2 ta ’ l- Applikazzjoni dwar l- Awtorizzazzjoni għat- Tqehħid fis- Suq u kull aġġornament sussegwenti ta ’ l- RMP miftiehem mas- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
(PSUR)
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Minbarra hekk, RMP aġġornat għandu jiġi sottomess: • Meta tasal informazzjoni ġdida li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni tas- Sigurtà attwali, il- Pjan ta ’ Farmakoviġilanza jew attivitajiet li jistgħu jiminimizzaw ir- riskju. • Fi żmien 60 jum minn meta jintlaħaq tragward importanti (farmakoviġilanza jew minimizzazzjoni ta ’ riskju) • Fuq talba ta ’ l- EMEA
CARTON TEXT
KITBA FUQ IL- KARTUNA
RELISTOR 12 mg/ 0.6 ml solution for injection.
RELISTOR 12 mg/ 0. 6 ml soluzzjoni għall- injezzjoni.
Sodium chloride, sodium calcium edetate, glycine hydrochloride, water for injections, hydrochloric acid (to adjust pH), sodium hydroxide (to adjust pH).
Sodium chloride, sodium calcium edetate, glycine hydrochloride, ilma għall- injezzjonijiet, hydrochloric acid (biex jaġġusta l- pH), sodium hydroxide (biex jaġġusta l- pH).
1 vial of 0.6 ml
Kunjett 1 ta ’ 0. 6 ml
2 vials of 0.6 ml 2 sterile 1 ml injection syringes with retractable injection needle 4 alcohol swabs
2 kunjetti ta ’ 0. 6 ml 2 siringi ta ’ l- injezzjoni sterili ta ’ 1 ml b’ labra ta ’ injezzjoni li tinġibed lura 4 ġbajjar ta ’ l- alkoħol
7 vials of 0.6 ml 7 sterile 1 ml injection syringes with retractable injection needle 14 alcohol swabs
7 kunjetti ta ’ 0. 6 ml 7 siringi ta ’ l- injezzjoni sterili ta ’ 1 ml b’ labra ta ’ injezzjoni li tinġibed lura 14- il ġbara ta ’ l- alkoħol
Wyeth Europa Limited Huntercombe Lane South Taplow, Maidenhead Berkshire SL6 0PH United Kingdom Tel:
Wyeth Europa Limited Huntercombe Lane South Taplow, Maidenhead Berkshire SL6 0PH Ir- Renju Unit Tel:
RELISTOR 12 mg/ 0.6 ml
RELISTOR 12 mg/ 0. 6 ml
15 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
17 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
TEXT FOR VIAL LABEL
TEST GĦAT- TIKKETTA TAL- KUNJETT
RELISTOR 12 mg/ 0.6 ml solution for injection.
RELISTOR 12 mg/ 0. 6 ml soluzzjoni għal injezzjoni.
0.6 ml of solution (12 mg methylnaltrexone bromide)
0. 6 ml ta ’ soluzzjoni (12 mg methylnaltrexone bromide)
16 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
18 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
LABEL TEXT FOR TRAY LIDDING
KITBA TAT- TIKKETTA GĦALL- GĦATU TAT- TREJ
RELISTOR 12 mg/ 0.6 ml solution for injection.
RELISTOR 20 mg/ 0. 6 ml soluzzjoni għall- injezzjoni.
INFORMATION FOR THE USER
20 FULJETT TA ’ TAGĦRIF:
RELISTOR 12 mg/ 0.6 ml solution for injection Methylnaltrexone bromide
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU RELISTOR 12 mg/ 0. 6 ml soluzzjoni għall- injezzjoni Methylnaltrexone bromide
It may harm them, even if
Tista ’ tagħmlilhom il- ħsara, anki
their symptoms are the same as yours.
jekk ikollhom l- istess sintomi bħal tiegħek.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin
tell your doctor or pharmacist.
f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek
What RELISTOR is and what it is used for 2.
X’ inhu RELISTOR u għalxiex jintuża 2.
Before you use RELISTOR 3.
Qabel ma tuża RELISTOR 3.
How to use RELISTOR 4.
Kif għandek tuża RELISTOR 4.
How to store RELISTOR 6.
Kif taħżen RELISTOR 6.
WHAT RELISTOR IS AND WHAT IT IS USED FOR
X’ INHU RELISTOR U GĦALXIEX JINTUŻA
RELISTOR treats constipation that is caused by medicines for moderate to severe pain called opioids (for example morphine, codeine).
RELISTOR jikkura l- istitikezza li tiġi kkaġunata minn mediċini għall- uġigħ minn moderat sa sever imsejħa opjojdi (per eżempju morphine (morfina), codeine).
Opioids are prescribed by your doctor.
L- opjojdi jiġu preskritti mit- tabib tiegħek.
RELISTOR is given on top of your usual laxatives.
RELISTOR jingħata qabel il- porog li tieħu s- soltu.
RELISTOR is for use in adults (aged 18 and over).
RELISTOR jista ’ jintuża f’ adulti (18- il sena ’ l fuq).
BEFORE YOU USE RELISTOR
QABEL MA TUŻA RELISTOR
Do not use RELISTOR
Tużax RELISTOR
- If you are allergic (hypersensitive) to methylnaltrexone bromide or any of the other ingredients.
- Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal methylnaltrexone bromide jew għal kwalunkwe
- If you or your doctor know that your bowels are obstructed or your bowels are in a state where
- Jekk int jew it- tabib tiegħek tafu li l- imsaren tiegħek huma imblukkati jew jekk l- imsaren tiegħek huma fi
there is an immediate need for surgical intervention (which has to be diagnosed by your doctor).
stat fejn intervent kirurġiku hu meħtieġ (li jrid jiġi dijanjostikat mit- tabib tiegħek).
Take special care with RELISTOR
Oqgħod attent ħafna b’ RELISTOR
- If you have severe liver or kidney disease.
- Jekk għandek mard tal- fwied jew tal- kliewi sever.
- If you develop severe or persistent diarrhoea (passing of frequent watery stools) discontinue
- Jekk tiżviluppa dijarea severa jew persistenti (tgħaddi ippurgar maħlul ta ’ spiss) waqqaf it- terapija u
therapy and contact your doctor immediately.
kkuntattja lit- tabib tiegħek minnufih.
- It is important to be near a toilet with assistance available if necessary, since bowel movement
- Huwa importanti li tkun qrib tojlit bl- assistenza disponibbli jekk ikun hemm bżonn, peress li l- ippurgar
may happen within 30 minutes after injection of the medicine.
jista ’ jseħħ fi żmien 30 minuta minn wara li tingħata l- injezzjoni tal- mediċina.
- Please talk to your doctor if you experience persistent stomach pain, nausea, (feeling sick in the
- Jekk jogħġbok kellem lit- tabib tiegħek jekk tħoss uġigħ persistenti fl- istonku, tqalligħ, (tħossok ma tiflaħx
stomach) or vomiting that is new or worsened.
fl- istonku) jew tibda tirremetti jew tirremetti aktar.
- Please also talk to your doctor if you have a colostomy, a peritoneal catheter, or already known
- Jekk jogħġbok kellem lit- tabib tiegħek jekk għandek kolostomija, kateter peritoneali, jew mard magħruf
disease called diverticular disease or faecal impaction.
diġà li jissejjaħ mard divertikulari jew sadd ta ’ l- ippurgar.
- If you have suffered from constipation before you had to take opioids (for pain), please also talk to
- Jekk batejt minn stitikezza qabel ma bdejt tieħu l- opjojdi (għal uġigħ), jekk jogħġbok kellem lit- tabib
your doctor.
tiegħek.
19 Using other medicines
Meta tieħu mediċini oħra
Your doctor may allow you to take other medicines, including those used for constipation.
It- tabib tiegħek għandu mnejn iħallik tieħu mediċini oħra inkluż dawk użati għal stitikezza.
Using RELISTOR with food and drink
Meta tieħu RELISTOR ma ’ l- ikel u x- xorb
RELISTOR can be taken with or without food.
RELISTOR jista ’ jittieħed ma ’ l- ikel jew mingħajr ikel.
The effects of methylnaltrexone bromide in pregnant women are not known, and so the use of RELISTOR during pregnancy is not recommended.
L- effetti ta ’ methylnaltrexone bromide f’ nisa waqt it- tqala mhux magħruf, u għalhekk l- użu ta ’ RELISTOR waqt it- tqala mhux rakkomandat.
Women using RELISTOR should not breast-feed, since it is not known if methylnaltrexone bromide passes into human breast milk.
In- nisa li jieħdu RELISTOR m’ għandhomx ireddgħu, peress li mhux magħruf jekk methylnaltrexone bromide jgħaddix mal- ħalib ta ’ l- omm.
RELISTOR may cause dizziness, and this may have an effect on driving and use of machines.
RELISTOR għandu mnejn jikkawża sturdamenti u dawn jistgħu ikollhom effett fuq is- sewqan u t- tħaddim ta ’ magni.
Important information about some of the ingredients of RELISTOR
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ RELISTOR
This medicine contains less than 1 mmol sodium (23 mg) per dose i. e., essentially “ sodium free .”
Din il- mediċina fiha inqas minn 1 mmol sodium (23 mg) f’ kull doża i. e., essenzjalment hija "ħielsa mis- sodium." ’
HOW TO USE RELISTOR
KIF GĦANDEK TUŻA RELISTOR
Always use RELISTOR exactly as your doctor has told you.
Dejjem għandek tuża RELISTOR skond il- parir tat- tabib.
The usual dose is 8 mg methylnaltrexone bromide (0.4 ml RELISTOR) for patients weighing 38-61 kg or 12 mg (0.6 ml RELISTOR) for patients weighing 62-114 kg.
Id- doża li ġeneralment tingħata hi ta ’ 8 mg methylnaltrexone (0. 4 ml RELISTOR) għal pazjenti li jiżnu 38- 61 kg jew 12 mg (0. 6 ml RELISTOR) għal pazjenti li jiżnu 62- 114 kg.
The dose is given every 48 hours (every two days) as an injection under the skin.
Id- doża tingħata kull 48 siegħa (kull jumejn) bħala injezzjoni taħt il- ġilda.
Your doctor will determine your dose.
It- tabib tiegħek jistabbilixxi d- doża li għandek tieħu.
RELISTOR is given by an injection under the skin (by subcutaneous injection) in either (1) your upper legs (thighs), (2) your abdomen (stomach), and (3) your upper arm (if not self-injecting).
RELISTOR jingħata bħala injezzjoni taħt il- ġilda (b’ injezzjoni subkutanja) jew (1) fil- parti ta ’ fuq ta ’ riġlejk (koxxa), (2) f’ żaqqek (l- istonku), u (3) fil- parti ta ’ fuq ta ’ driegħek (jekk ma tinjettax lilek innifsek).
(See INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF RELISTOR AT THE END OF THIS LEAFLET.)
(Ara STRUZZJONIJIET DWAR KIF TIPPREPARA U TAGĦTI L- INJEZZJONI TA ’ RELISTOR FL- AĦĦAR TA ’ DAN IL- FULJETT.)
You may have a bowel movement within a few minutes to a few hours of the injection; therefore, it is recommended to have a toilet facility or bedpan near you.
22 Għandek mnejn tipporga fi żmien ftit minuti sa ftit sigħat wara l- injezzjoni; għalhekk, huwa rakkomandat li jkollok tojlit jew patella ħdejk.
If you use more RELISTOR than you should
Jekk tieħu RELISTOR aktar milli suppost
If you have used more RELISTOR than you should (either by injecting too much on a single occasion or by using more than one injection in 24 hours), talk to a doctor or pharmacist immediately.
Jekk ħadt aktar RELISTOR milli suppost (billi injettajt aktar milli meħtieġ f’ okkażjoni waħda jew billi ħadt aktar minn injezzjoni waħda f’ 24 siegħa), kellem lit- tabib jew l- ispiżjar tiegħek minnufih.
Always have the outer carton of the medicine with you, even if it is empty.
Dejjem żmomm il- kartuna ta ’ barra tal- mediċina miegħek, anke jekk tkun vojta.
20 If you forget to use RELISTOR
Jekk tinsa tieħu RELISTOR
If you forget a dose, talk to your doctor or pharmacist as soon as possible.
Jekk tinsa tieħu d- doża, kellem lit- tabib jew l- ispiżjar tiegħek minnufih.
If you stop using RELISTOR
Jekk tieqaf tieħu RELISTOR
If you stop using RELISTOR, talk to a doctor or pharmacist.
Jekk tieqaf tieħu RELISTOR, kellem lil tabib jew spiżjar.
Like all medicines, RELISTOR can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, RELISTOR jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The most common side effects likely to occur in more than 1 in 10 patients:
L- aktar effetti sekondarji komuni li x’ aktarx iseħħu f’ aktar minn pazjent 1 f’ kull 10 huma:
• Abdominal pain (belly ache)
• Uġigħ addominali (uġigħ ta ’ żaqq)
• Nausea (feeling sick in the stomach)
• Dardir (tħoss l- istonku mdardar)
• Flatulence (passing wind)
• Gass (tbasbas)
• Diarrhoea (passing of frequent watery stools)
• Dijarea (tipporga maħlul ta ’ spiss)
Common side effects reported in more than one in 100 patients, but in less than one in ten patients receiving RELISTOR are:
Effetti sekondarji komuni rraportati f’ aktar minn pazjent wieħed f’ kull 100, imma inqas minn wieħed f’ kull għaxra li qed jirċievu RELISTOR huma:
• Dizziness (light-headed)
• Sturdamenti (tħossok mitluf)
• Reaction at the site of injection (e. g., stinging, burning, pain redness, oedema)
• Reazzjoni fis- sit ta ’ l- injezzjoni (eż. tingiż, ħruq, ħmura bl- uġigħ, tbenġil),
HOW TO STORE RELISTOR
KIF TAĦŻEN RELISTOR
Do not use RELISTOR after the expiry date, which is stated on the carton and vial.
Tużax RELISTOR wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- kunjett.
Keep the vial in the outer carton in order to protect from light.
23 Żomm il- kunjett fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
Only use RELISTOR if the solution is clear, colourless to pale yellow, and does not contain flakes or particles.
Uża RELISTOR biss jekk is- soluzzjoni tkun ċara, mingħajr kulur jew tkanġi f’ isfar ċar, u ma fihiex biċċiet jew frak.
The syringe and needle should NEVER be reused.
Is- siringa u l- labra QATT m’ għandhom jerġgħu jintużaw.
NEVER recap the needle.
QATT m’ għandek terġa tgħatti l- labra.
Dispose the needle and syringe as instructed by your doctor, nurse or pharmacist.
Armi l- labra u s- siringa skond l- istruzzjonijiet tat- tabib, in- ners jew l- ispiżjar tiegħek.
What RELISTOR contains
X’ fih RELISTOR
The active substance is methylnaltrexone bromide.
Is- sustanza attiva hi methylnaltrexone bromide.
One ml of solution contains 20 mg methylnaltrexone bromide.
Millilitru ta ’ soluzzjoni fih 20 mg methynaltrexone bromide.
The other ingredients are sodium chloride, sodium calcium edetate, glycine hydrochloride, water for injections, hydrochloric acid (to adjust pH) and sodium hydroxide (to adjust pH).
Is- sustanzi l- oħra huma sodium chloride, sodium calcium edetate, glycine hydrochloride, ilma għall - injezzjonijiet, hydrochloric acid (biex jaġġusta l- pH) u sodium hydroxide (biex jaġġusta l- pH).
What RELISTOR looks like and contents of the pack
Id- dehra ta ’ RELISTOR u l- kontenut tal- pakkett
RELISTOR is a solution for injection.
RELISTOR hija soluzzjoni għall- injezzjoni.
It is clear, colourless to pale yellow, and does not contain flakes or particles.
Hija ċara u mingħajr kulur li tkanġi f’ isfar ċar u ma fihiex biċċiet jew frak.
Each vial contains 0.6 ml of solution.
Kull kunjett fih 0. 6 ml ta ’ soluzzjoni.
Packs of more than one vial contain trays consisting of: one vial, one 1 ml injection syringe with retractable injection needle, and two alcohol swabs:
Pakketti ta ’ aktar minn kunjett wieħed fihom trejs li jikkonsistu minn: kunjett wieħed, siringa ta ’ l- injezzjoni ta ’ 1 ml b’ labra ta ’ l- injezzjonijiet li tinġibed lura u żewġ ġbajjar ta ’ l- alkoħol.
The following packs are available:
Il- pakketti li ġejjin huma disponibbli:
Single vial
Kunjett wieħed
Pack containing 2 vials, 2 injection syringes with retractable injection needle, and 4 alcohol swabs (i. e.
Pakkett li fih 2 kunjetti, 2 siringi ta ’ l- injezzjoni b’ labra ta ’ l- injezzjoni li tinġibed lura, u 4 ġbajjar ta ’ l- alkoħol (i. e.
2 trays).
2 trejs)
Pack containing 7 vials, 7 injection syringes with retractable injection needle, and 14 alcohol swabs (i. e.7 trays).
7 trejs)
Marketing Authorisation Holder:
Wyeth Europa Limited.
Wyeth Europa Limited Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH United Kingdom Tel:
Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH Ir- Renju Unit Tel:
Via Franco Gorgone Zona Industriale 95030 Catania Italy
Via Franco Gorgone Zona Industriale 95030 Catania L- Italja
23 Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
There are also links to other web sites about rare diseases and treatments.
Hemm ukoll links għall- websites oħra dwar mard rari u kura. < ----------------------------------------------------------------------------------------------------------------------------------------
24 INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF RELISTOR
26 STRUZZJONIJIET DWAR KIF TIPPREPARA U TAGĦTI INJEZZJONI TA ’ RELISTOR
This section is divided into the following subsections:
Din it- taqsima hija mqassma fis- subsezzjonijiet li ġejjin:
Introduction Step 1:
Daħla Step 1:
Setting up for an injection Step 2:
Kif tħejji ruħek għal injezzjoni Step 2:
Preparing the injection syringe Step 3:
Kif tipprepara s- siringa għall- injezzjoni Step 3:
Choosing and preparing an injection site Step 4a:
Kif tagħżel u tipprepara s- sit għall- injezzjoni Step 4a:
Injecting RELISTOR using a pack containing injection syringe with retractable injection needle Step 4b:
Kif tinjetta RELISTOR li jiġi f’ pakkett li fih siringa ta ’ l- injezzjoni b’ labra li tinġibed lura Step 4b:
Injecting RELISTOR using a standard injection syringe and injection needle
Kif tinjetta RELISTOR permezz ta ’ siringa ta ’ l- injezzjoni u labra ta ’ l- injezzjoni standard
Introduction
Daħla
The following instructions explain how to inject RELISTOR.
L- istruzzjonijiet li ġejjin jispjegaw kif tinjetta RELISTOR.
Please read the instructions carefully and follow them step by step.
Jekk jogħġbok aqra l- istruzzjonijiet sew u segwihom pass wara pass.
You will be instructed by your healthcare professional on the techniques of self-administration.
Inti ser tingħata struzzjonijiet mill- professjonist tal- kura tas- saħħa tiegħek dwar it- teknika ta ’ awto- amministrazzjoni.
Do not attempt to administer an injection until you are sure that you understand how to give the injection.
Tipprovax tagħtiha qabel ma tkun żgur li tifhem kif għandek tagħti l- injezzjoni.
This injection should not be mixed in the same syringe with any other medicine.
Din l - injezzjoni m’ għandiex titħallat fl- istess siringa ma ’ xi mediċina oħra.
You may receive either a pack containing a tray with everything needed for the injection, or a single vial only.
Inti tista ’ tirċievi pakkett li fih trej b’ dak kollu li għandek bżonn għall- injezzjoni, jew inkella kunjett wieħed biss.
If you receive only the vial, you will need to obtain alcohol swabs and an injection syringe.
Jekk tirċievi l- kunjett biss, inti jkollok bżonn ukoll l- imsiħ ta ’ l- alkoħol u siringa ta ’ l- injezzjoni.
Step 1:
Stadju 1:
Setting up for an injection
Kif tħejji għal injezzjoni
Select a flat, clean, well-lit working surface.
Agħżel superfiċje ċatta, nadifa u mdawwla.
Wash your hands with soap and warm water.
Aħsel idejk bis- sapun u ilma daqsxejn sħun.
Assemble the supplies you will need for your injection.
Iġbor l- affarijiet li għandek bżonn għall- injezzjoni tiegħek.
These include the RELISTOR vial, a 1 ml injection syringe (with or without retractable needle), 2 alcohol swabs, and a cotton ball or gauze.
Dawn jinkludu l- kunjett ta ’ RELISTOR, siringa ta ’ l- injezzjoni ta ’ 1 ml (b’ labra li tinġibed lura jew mingħajrha), 2 msiħ ta ’ l- alkoħol, biċċa tat - tajjar jew garża
Make sure the solution in the vial is clear and colourless to pale yellow, and does not contain flakes or particles.
Aċċerta ruħek li s- soluzzjoni fil- kunjett hija ċara u ta ’ mingħajr ebda lewn jew tkanġi fl- isfar ċar u ma fihiex biċċiet jew partiċelli viżibbli.
If it is not, do not use the solution.
Jekk ma tkunx m’ għandekx tuża s- soluzzjoni.
Contact your pharmacist, nurse or physician for assistance.
Ikkuntattja lil spiżjar, ners jew tabib tiegħek għal assistenza.
Step 2:
Stadju 2:
Preparing the injection syringe
Kif tipprepara s- siringa ta ’ l- injezzjoni
Remove the protective cap from the vial.
Neħħi l- għatu protettiv minn mill- kunjett.
Wipe the vial’ s rubber stopper with an alcohol swab and place it on your flat work surface.
Imsaħ t- tapp tal- lastku bi ġbara ta ’ l- alkoħol u poggih fuq is- superfiċje tal- bank ta ’ fejn qed taħdem.
Pick up the syringe from your work surface.
Aqbad is- siringa minn fuq is- superfiċje tal- bank ta ’ fejn qed taħdem.
Hold the barrel of the syringe with one hand and pull the needle cover straight off.
Żomm it- tubu tas- siringa b’ id waħda u iġbed l- għatu tal- labra bu dritt ’ l barra.
Place the needle cover back on the work surface.
Qiegħed l- għatu tal- labra lura fuq is- superfiċje ta ’ fejn qed taħdem.
Do not touch the needle or allow it to touch any surface.
M’ għandekx tmiss il- labra jew tħalliha tmiss ma ’ xi superfiċje.
Carefully pull the syringe plunger back until the end of the plunger is at the line that represents your dose.
B’ attenzjoni iġbed il- planġer tas - siringa lura sakemm it- tarf tal- planġer ikun fil- linja li jirrappreżenta d- doża tiegħek.
Insert the needle straight down into the centre of the vial stopper.
Daħħal il- labra minn ġoċ- ċentru tat- tapp tal- kunjett.
Do not insert it at an angle as the needle may bend or break.
Iddaħaliex f’ angolu peress li l- labra tista ’ titgħawweġ jew tinqasam.
You will feel a slight resistance as the needle passes through the stopper.
Għandek tħoss ftit reżistenza kif il- labra tgħaddi minn ġot- tapp.
Look for the needle tip inside the vial.
Fittex il- ponta tal- labra fil - kunjett.
In order to get the air out of the syringe, gently push the plunger down to inject the air into the vial.
Sabiex toħroġ l- arja ’ l barra mis- siringa, bil- mod imbotta l- planġer ’ l isfel sabiex tinjetta l- arja fil - kunjett.
If you are using the supplied injection syringe with retractable injection needle, DO NOT PUSH THE PLUNGER DOWN COMPLETELY.
Jekk tuża s- siringa ta ’ l- injezzjoni fornuta b’ labra ta ’ l- injezzjoni li tinġibed lura, TIMBUTTAX IL- PLANĠER ’ L ISFEL KOLLU.
Make sure you stop pushing the plunger when you feel resistance.
Kun żgur li tieqaf timbotta l- planġer meta tħoss reżistenza.
If you push the plunger completely, you will hear a ‘ click’ sound.
Jekk timbotta l- planġer kompletament, ser tisma ’ ħoss ta ’ ‘ klikk ’.
This will mean that the safety mechanism has been activated, and the needle will disappear into the syringe.
Dan ifisser li l- mekkaniżmu tas- sigurtà ġie attivat, u l- labra ser tisparixxi fis- siringa.
If this happens, discard the product and start again using another vial and syringe.
Jekk dan iseħħ, armi l- prodott u erġa ’ ibda mill- ġdid billi tuża kunjett u siringa oħra.
With the needle still in the vial, turn the vial upside-down.
Bil- labra fil- kunjett, aqleb il- kunjett rasu ’ l isfel.
Hold the syringe at eye level and make sure the tip of the needle is in the fluid all of the time.
Żomm is- siringa mal- livell ta ’ għajnejk u kun żgur li t - tarf tal- labra ikun fil- likwidu l- ħin kollu.
Slowly pull the plunger down to the dosage marking on the syringe that matches your dose.
Bil- mod iġbed il- planġer ’ l isfel sal- marka tad- doża li taqbel mad- doża tiegħek fuq is- siringa.
You may see some fluid or bubbles inside the vial when the syringe is properly filled.
Għandek mnejn tara xi fluwidu jew bżieżaq ġol- kunjett meta s- siringa timtela sewwa.
With the needle still inserted in the upside down vial, check for air bubbles in the syringe.
Bil- labra għadha mdaħħla fil- kunjett rasu ’ l isfel, iċċekkja għal bżieżaq ta ’ l- arja fis- siringa.
Gently tap the syringe to make any air bubbles rise to the top of the syringe; be sure that you still hold onto the vial and syringe.
Bil- mod taptap is- siringa sabiex il- bżieżaq ta ’ l- arja jitilgħu fin- naħa ta ’ fuq tas- siringa: kun ċert li tibqa ’ żżomm il- kunjett u s- siringa.
Slowly push the plunger up until all air bubbles are removed.
Bil- mod imbotta l- planġer sakemm il- bżieżaq kollha jitilqu.
If you push solution back into the vial, slowly pull back the plunger to draw the correct amount of solution back into the syringe.
Jekk timbotta s - soluzzjoni lura fil- kunjett, bil- mod imbotta lura ’ l planġer sabiex tiġbed l- ammont korrett ta ’ soluzzjoni lura fis- siringa.
Remove the syringe and needle from the vial.
Neħħi s- siringa u l- labra minn ġol- kunjett.
Keep the needle attached to the syringe.
Żomm il- labra mqabbda mas- siringa.
Do not touch the needle or allow the needle to touch any surface.
Tmissx il- labra jew tħalli l- labra tmiss ma ’ xi superfiċje.
26 Step 3:
28 Stadju 3:
Choosing and preparing an injection site
Kif tagħżel u tipprepara sit għall- injezzjoni
The three areas of the body recommended for injection of RELISTOR are:
It- tliet żoni tal- ġisem li huma rakkomandati għal injezzjoni ta ’ RELISTOR huma:
(1) your upper legs (thighs), (2) your abdomen (stomach), and (3) your upper arm (if not self injecting).
(1) in- naħa ta ’ fuq ta ’ riġlejk (il- koxox), (2) żaqqek (l- istonku), u (3) in- naħa ta ’ fuq ta ’ dirgħajk (jekk mhux b’ awto- injezzjoni).
It is recommended to move to a different site each time an injection is given.
Huwa rakkomandat li ddawwar il- post kull darba li tieħu injezzjoni oħra.
Avoid repeated injections at the exact same spot previously used.
Evita li tagħti injezzjonijiet ripetuti fl- istess post.
Do not inject into areas where the skin is tender, bruised, red, or hard.
M’ għandekx tinjetta f’ postijiet fejn il- ġilda tkun ratba, imbenġla, ħamra, jew iebsa.
Avoid areas with scars or stretch marks.
Evita postijiet b’ farretti jew stretch marks.
To prepare the area of skin where RELISTOR is to be injected, wipe the injection site with an alcohol swab.
Sabiex tipprepara l- ġilda fejn RELISTOR ser jiġi injettat, naddaf il- post fejn ser tinjetta bi ġbara ta ’ l - alkoħol.
DO NOT TOUCH THIS AREA AGAIN BEFORE GIVING THE INJECTION.
M’ GĦANDEKX TERĠA ’ TMISS DAN IL- POST QABEL MA TAGĦTI L- INJEZZJONI.
Allow the injection site to air-dry before injecting.
Ħalli s- sit ta ’ l- injezzjoni jinxef waħdu qabel ma tinjetta.
Step 4a:
Stadju 4a:
Injecting RELISTOR using a pack containing injection syringe with retractable injection needle
Kif tinjetta s- soluzzjoni RELISTOR li jiġi f’ pakkett li fih siringa ta ’ l- injezzjoni b’ labra ta ’ l - injezzjoni li tinġibed lura
Holding the filled syringe with the needle pointing up, recheck the syringe for air bubbles.
Jekk 1. ikun hemm bżieżaq, taptap bil- mod is- siringa b’ subajk sakemm il- bżieżaq jitilgħu ’ l fuq fis- siringa.
If there are bubbles, gently tap the syringe with your finger until the air bubbles rise to the top of the syringe.
Bil - mod imbotta l- planġer ’ l fuq sabiex tisforza l- bżieżaq ’ l barra minn ġos- siringa.
Slowly push the plunger up to force the air bubbles out of the syringe.
Żomm is- siringa b’ id waħda bħal lapes.