qanastek/EMEA-V3 huggingface dataset:
Since absorption is insignificant from the site of topical application in man, carcinogenesis and reproductive toxicity studies have not been conducted with REGRANEX.
Minħabba li l- assorbiment huwa insinifikanti mis- sit tal- applikazzjoni topikali fil- bniedem, ma ġewx kondotti studji ta ’ karċinoġeniċita` u tossiċita` riproduttiva b’ REGRANEX.
In the process of healing the wound, becaplermin induces cell proliferation.
Fil- proċess tal- fejqan tal- ferita, becaplermin jinduċi l- proliferazzjoni taċ- ċelluli.
However, skin tumours have not been reported in the clinical trials at the site of application or in close proximity.
Iżda, ma ġewx irrapurtati tumuri fil- ġilda fil- provi kliniċi fuq is- sit tal- applikazzjoni jew fil- viċin.
In a preclinical study designed to determine the effects of PDGF on exposed bone, rats injected at the metatarsals with 3 or 10 µg/ site (concentration of 30 or 100 µg/ ml/ site) of becaplermin every other day for 13 days displayed histological changes indicative of accelerated bone remodelling consisting of periosteal hyperplasia and subperiosteal bone resorption and exostosis.
Fi studji ta ’ qabel l- użu kliniku ddiżinjati sabiex jiddeterminaw l- effetti ta’ PDGF fuq għadam espost, firien li ġew injettati fil- metatarsali bi 3 jew 10 μg/ sit (konċentrazzjoni ta ’ 30 jew 100 μg/ ml/ sit) ta ’ becaplermin kull jum alternattiv għal 13- il jum wera kambjamenti istoloġiċi indikattivi għal rimudellar aċċellerat tal- għadam konsistenti f’ iperplasija perjostali u assorbiment mill- ġdid subperjostali tal- għadam u esostożi.
The soft tissue adjacent to the injection site had fibroplasia with accompanying mononuclear cell infiltration reflective of the ability of PDGF to stimulate connective tissue growth.
It- tessut artab qrib is- sit tal- injezzjoni kellu fibroplasia akkumpanjat b’ infiltrazzjoni ta ’ ċelluli mononukleari li jirrifletti l- abilita` ta ’ PDGF sabiex jistimula t - tkabbir ta ’ tessut konnettiv.
Preclinical absorption studies through full-thickness wounds were conducted in rats with a wound area of 1.4 - 1.6 cm².
Studji ta ’ l- assorbiment qabel l- użu kliniku f’ feriti tal- ħxuna massima ġew kondotti fuq firien b’ erja ta ’ ferita ta ’ 1. 4 – 1. 6ċm2.
Systemic absorption of a single dose and multiple applications for 5 consecutive days of becaplermin to those wounds was insignificant.
Assorbiment sistemiku ta ’ doża singola u applikazzjonijiet multipli għal 5 t’ ijiem konsekuttivi ta ’ becaplermin fuq dawk il- feriti kien insinifikanti.
carmellose sodium (E466) sodium chloride sodium acetate glacial acetic acid (E260) methyl parahydroxybenzoate (methylparaben) (E218) propyl parahydroxybenzoate (propylparaben) (E216) m-cresol lysine hydrochloride water for injections
carmellose sodium (E466) sodium chloride sodium acetate glacial acetic acid (E260) methyl parahydroxybenzoate (methylparaben) (E218) propyl parahydroxybenzoate (propylparaben) (E216) m- cresol lysine hydrochloride ilma għal injezzjonijiet
There are no known incompatibilities.
M’ hemmx inkompatibilitajiet magħrufa.
Use within 6 weeks after first opening.
Uża fi żmien 6 ġimgħat minn meta jinfetaħ.
REGRANEX is supplied in 15 g laminated polyethylene-lined multidose tubes.
REGRANEX jinbieh f’ tubi ta ’ 15gr dożi multipli laminati u inforrati bil- polyethylene.
6.6 Instructions for use and handling, and disposal
6. 6 Struzzjonijiet għall- użu u maniġġar u għar- rimi
(See section 4.2).
(Ara sezzjoni 4. 2)
- A tube of REGRANEX should be used on a single patient only.
-
- Care should be taken during use to avoid microbial contamination and spoilage.
Għandu jkun hemm attenzjoni waqt l- użu sabiex ma jkunx hemm kontaminazzjoni mikrobjali u taħsir.
- Hands should be washed thoroughly before applying REGRANEX.
- - -
- The tip of the tube should not come into contact with the wound or any other surface.
It- tarf tat- tubu m’ għandux imiss mal- ferita jew ma xi superfiċji oħrajn.
- The use of a clean application aid is recommended and contact with other parts of the body should
Huwa rrakomandat l- użu ta ’ mezz għall- applikazzjoni nadif u għandu jiġi evitat kuntatt ma ’ partijiet oħrajn tal- ġisem.
be avoided.
-
- Before each application, the ulcer should be gently rinsed with saline or water to remove residual
Qabel kull applikazzjoni, l- ulċera għanda tiġi imlaħalħa ġentilment b’ saline jew ilma sabiex jitneħħa xi residwu ta ’ ġell.
gel.
- -
- The tube should be closed tightly after each use.
It- tubu għandu jingħalaq sewwa wara kull użu.
- After treatment is completed, any unused gel should be discarded.
Wara li jiġi kompletat it- trattament, kwalunkwe ġell mhux użat għandu jintrema.
NUMBER IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
March 29, 1999/ March 31, 2004
29 ta’ Marzu 1999/ 31 ta ’ Marzu 2004
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U SID L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT B.
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U SID L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL - LOTT
Name and address of the manufacturers of the biological active substance
Isem u indirizz tal- manufattur tas- sustanza bijoloġika attiva
Janssen-Pharmaceutica N. V., Turnhoutseweg 30, B-2340 Beerse, Belgium.
Janssen- Pharmaceutica N. V., Turnhoutseweg 30, B- 2340 Beerse, Belgium
Medicinal product subject to restricted medical prescription (see Annex I:
Prodott mediċinali jingħata b' riċetta ristretta tat- tabib (Ara Anness I:
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Is- sid ta 'din l- awtorizzazzjoni għall- kummerċ għandu jagħti tagħrif lill- Kummissjoni Ewropeja dwar il- pjanijiet kummerċjali tal- prodott mediċinali awtorizzat b' din id- deċiżjoni.
10 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
10 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA JEW, FIN- NUQQAS TA 'DAN, FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
REGRANEX 0.01% gel becaplermin
REGRANEX 0. 01% ġell becaplermin
100 microgram / g gel becaplermin
100 mikrogramma/ g ġell becaplermin
Contains carmellose sodium (E466), sodium chloride, sodium acetate, glacial acetic acid (E260), methyl parahydroxybenzoate (methylparaben) (E218), propyl parahydroxybenzoate (propylparaben) (E216), m-cresol, lysine hydrochloride and water for injections.
Fih carmellose sodium (E466), sodium chloride, sodium acetate, glacial acetic acid (E260), methyl parahydroxybenzoate (methylparaben) (E218), propyl parahydroxybenzoate (propylparaben) (E216), m- cresol, lysine hydrochloride, ilma għal injezzjonijiet
Multidose tube containing 15 gram of gel
Tubu ta ’ dożi multipli li fih 15 gramma ġell
For cutaneous use only
Għal użu kutanju biss
Marketing authorisation holder:
Sid l- awtorizzazzjoni għall- kummerċ:
Batch No.
Lott
Read the package leaflet before use Use within 6 weeks after first opening
Aqra l- fuljett ta ’ tagħrif qabel l- użu Uża fi żmien 6 ġimgħat minn meta jinfetaħ
Date opened:
Data li infetaħ:
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
12 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA JEW, FIN- NUQQAS TA 'DAN, FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
TUBE
TUBU
Date
JIS [XX/ SSSS]
Store in a refrigerator (2°C - 8°C) Do not freeze Close tightly after each use
Għalaq sewwa wara kull użu.
Please read this leaflet carefully because it contains important information about your medicine.
Jekk jogħġbok aqra sew dan il- fuljett kollu, għax fih tagħrif importanti fuq il- mediċina tiegħek.
If there is anything that you do not understand or if you need further information or advice, you should ask your doctor or your pharmacist who will have more details.
Jekk hemm xi ħaġa li ma tifhimx jew jekk tkun trid aktar tagħrif jew pariri, għandek tistaqsi lit- tabib jew spiżjar tiegħek li jkollu iktar dettalji.
What REGRANEX is and what it is used for 2.
X’ inhu REGRANEX u għalxiex jintuża 2.
Before you use REGRANEX 3.
Qabel ma tuża REGRANEX 3.
How to use REGRANEX 4.
Kif għandek tuża REGRANEX 4.
Storing REGRANEX 6.
Kif taħżen REGRANEX 6.
REGRANEX 0.01% Gel Becaplermin
REGRANEX 0. 01% Ġell Becaplermin
The active substance in REGRANEX is becaplermin.
Is- sustanza attiva f ’ REGRANEX hi becaplermin.
Each gram of REGRANEX contains 100 micrograms of becaplermin.
Kull gramma ta ’ REGRANEX fiha 100 mikrogramma ta ’ becaplermin.
The other ingredients are: carmellose sodium (E466), sodium chloride, sodium acetate, glacial acetic acid (E260), methyl parahydroxybenzoate (methylparaben) (E218), propyl parahydroxybenzoate (propylparaben) (E216), m-cresol, lysine hydrochloride and water for injections.
L- ingredjenti l- oħrajn huma: carmellose sodium (E466), sodium chloride, sodium acetate, glacial acetic acid (E260), methyl parahydroxybenzoate (methylparaben) (E218), propyl parahydroxybenzoate (propylparaben) (E216), m- cresol, lysine hydrochloride u ilma għal injezzjonijiet.
WHAT REGRANEX IS AND WHAT IT IS USED FOR
X’ INHU REGRANEX U GĦALXIEX JINTUŻA
Becaplermin is a human recombinant Platelet Derived Growth Factor (rhPDGF), which helps the growth of normal tissue in order to heal ulcers.
Becaplermin huwa Fattur tat- Tkabbir Derivat mill- Platelet uman rikombinanti – BB (rhPDGF- BB) li jgħin fit- tkabbir ta ’ tessut normali sabiex jitfejqu l- ulċeri.
REGRANEX is a clear colourless to straw-coloured non-sterile preserved gel and is filled in multidose tubes containing 15 grams.
REGRANEX huwa ġell priżervat non- sterile ċar u mingħajr kulur sa kulur it- tiben u jsir f’ tubi ta ’ dożi multipli li fihom 15- il gramma.
REGRANEX is used in association with other good wound care measures to promote the healing of skin ulcers that measure less than or equal to 5 square centimetres which are due to complications of diabetes and have adequate blood supply.
REGRANEX huwa wżat flimkien ma ’ miżuri tajbin għall- kura ta ’ feriti sabiex jippromwovi l- fejqan ta ’ ulċeri tal- ġilda ta ’ kejl inqas minn jew daqs 5 ċentimetri kwadri li huma konsegwenza ta ’ kumplikazzjonijiet ta ’ dijabete u għandhom suppliment ta ’ demm adegwat.
By using REGRANEX, it is more likely that your ulcers will heal completely and that the time needed for your ulcers to heal will be reduced.
Bl- użu ta ’ REGRANEX, huwa iktar possibbli li l- ulċeri tiegħek ifiequ kompletament u ż- żmien li jkun hemm bżonn sabiex ifiequ l- ulċeri jiġi ridott.
BEFORE YOU USE REGRANEX
QABEL MA TUŻA REGRANEX
Do not to use REGRANEX:
Tużax REGRANEX:
- If you are allergic to the active substance or to the other ingredients of REGRANEX.
- Jekk tbati minn allerġija għas- sustanza attiva jew għall- ingredjenti l- oħrajn ta ’ REGRANEX
- If you have a skin tumour at or near the site of application of REGRANEX.
- Jekk int għandek tumur fil- ġilda fis- sit jew ħdejn is- sit tal- applikazzjoni ta ’ REGRANEX.
- If your ulcer is infected.
- Jekk l- ulċera tiegħek hija infettata.
Should your wound become infected during the use of REGRANEX,
Jekk il- ferita tiegħek issir infettata waqt l- użu ta ’
the product should be discontinued until the infection has cleared.
REGRANEX, il- prodott m’ għandux jitkompla jintuża sakemm tiċċara l- infezzjoni.
- If your ulcer is larger than 5 square centimetres
- Jekk l- ulċera tiegħek hija ikbar minn 5 ċentimetri kwadri.
Take special care with REGRANEX
Oqgħod attent ħafna b’ REGRANEX:
- Special warning
- Twissija speċjali
You should inform your doctor if you have any malignant condition(s).
Għandek tinforma lit- tabib tiegħek jekk għandek xi kundizzjoni( jiet) malinja (/ i)
- Pregnancy and breast-feeding
- Tqala u treddigħ
REGRANEX should not be used by pregnant women or by nursing mothers.
REGRANEX m’ għandux jintuża minn nisa tqal jew minn ommijiet li qed ireddgħu.
- Children and the elderly
- Tfal u anzjani
REGRANEX has not been tested in children under the age of 18.
REGRANEX ma ġiex ippruvat fuq tfal ta ’ taħt 18- il sena.
There are no special instructions necessary for the elderly.
Ma hemmx struzzjonijiet speċjali neċessarji għall- anzjani.
- Other medicines
- Mediċini oħrajn
You should not apply other topical medicines on your ulcer while using REGRANEX.
M’ għandekx tapplika mediċini topiċi oħrajn fuq l- ulċera waqt li qed tuża REGRANEX.
Only saline sodium chloride solution or water should be used to clean the ulcer.
Għanda tintuża biss soluzzjoni ta ’ saline sodium chloride jew ilma sabiex titnaddaf l- ulċera.
- Driving and operating machinery
- Sewqan u tħaddim ta ’ magni:
Not applicable
Ma japplikax.
HOW TO USE REGRANEX
KIF JINTUŻA REGRANEX
Please observe these instructions for use, in order to fully benefit from REGRANEX
Jekk jogħġbok segwi dawn l- istruzzjonijiet għall- użu sewwa, sabiex tibbenefika kompletament minn REGRANEX.
Before treatment with REGRANEX, your ulcer should be cleaned.
Qabel it- trattament b ’ REGRANEX, l- ulċera għanda tiġi mnaddfa.
It is very important to make sure that you also take very good care of your ulcers while using REGRANEX to help them heal quickly and as fully as possible.
Huwa importanti ħafna wkoll illi inti tieħu ħsieb l- ulċeri sewwa waqt li tuża REGRANEX sabiex tgħin li jfiequ malajr u b’ mod komplet kemm jista jkun.
If you experience signs of infection of the ulcer (e. g. redness, swelling, fever, pain, odour), you should consult your doctor immediately for specific treatment.
Jekk tesperjenza xi sinjali ta ’ infezzjoni tal- ulċera (p. e. ħmura, nefħa, deni, uġigħ, riħa), għandek tikkonsulta mat- tabib immedjatament għal trattament speċifiku.
You should not apply pressure or walk on the ulcer during treatment and should closely follow your doctor’ s advice on proper care of the ulcer together with other measures that may be needed to relieve pressure from your ulcer.
M’ għandekx tapplika pressjoni jew timxi fuq l- ulċera waqt it- trattament u għandek issegwi l- parir tat- tabib bir- reqqa għal kura tajba tal- ulċera flimkien ma ’ miżuri oħra li jista jkun hemm bżonn sabiex tittaffa l- pressjoni minn fuq l- ulċera.
Before REGRANEX you should wash your hands thoroughly.
Qabel ma tuża REGRANEX għandek taħsel idejk sewwa.
Before each application, the ulcer should be gently rinsed with saline or water to remove residual gel.
Qabel kull applikazzjoni, l- ulċera għandha titlaħlaħ ġentilment b’ saline jew ilma sabiex jitneħħa residwu ta ’ ġell.
Apply REGRANEX as a continuous thin layer to the entire wound area(s) once daily using a clean application aid (e. g. a cotton swab or a tongue depressor).
Applika REGRANEX bħala saff irqiq kontinwu fuq l- erja kollha tal- ferita darba kuljum billi tuża mezz għall- applikazzjoni nadifa (p. e. tajjara jew strument li jippressa l- ilsien ‘ l isfel).
Contact with other parts of the body should be avoided.
Għandu jiġi evitat kuntatt ma ’ partijiet oħra tal- ġisem.
The tip of the tube should not come into contact with the wound or any other surface and care should be taken during use to avoid any other forms of possible microbial contamination or spoilage.
It- tarf tat- tubu m’ għandux jiġi f’ kuntatt mal- ferita jew ma ’ xi superfiċji oħra u għanda tingħata attenzjoni sabiex jiġu evitati forom oħra ta ’ kontaminazzjoni mikrobjali possibbli jew taħsir.
Once REGRANEX has been applied, cover the ulcer with a moist saline gauze dressing.
Ladarba jiġi applikat REGRANEX, għatti l- ulċera b ’ garża niedja b’ saline.
The dressing should be changed at least once a day to keep the wound moist.
Il- garża għanda tiġi mibdula ta ’ l- inqas darba kuljum sabiex il- ferita tinżamm niedja.
REGRANEX should only be applied
REGRANEX għandu jiġi applikat
17 once daily even if you change your dressing more frequently.
17 biss darba kuljum anke jekk il- garża tinbidel iktar ta ’ spiss.
REGRANEX should not be used with occlusive dressings.
REGRANEX m’ għadux jintuża ma ’ garżi okklużiva.
REGRANEX should not be used for more than 20 weeks.
REGRANEX m’ għandux jintuża għal iktar minn 20 ġimgħa.
If there is no sign of healing after the first ten weeks of continuous therapy, please contact your doctor.
Jekk ma hemm l- ebda sinjal ta ’ fejqan wara l- ewwel għaxar ġimgħat ta ’ terapija kontinwa, informa lit - tabib tiegħek.
Your doctor will decide whether treatment should be continued.
It- tabib tiegħek jiddeċiedi jekk għandekx tkompli t- trattament.
REGRANEX is not intended for repeated use.
REGRANEX mhux intiż għal użu ripetut.
This medicinal product has been prescribed for you personally and you should not pass it on to others.
Dan il- prodott mediċinali ġie miktub lilek personalment u m’ għandekx tgħaddih lil ħaddieħor.
Any unfinished gel should be discarded after treatment is completed.
Kwalunkwe ġell mhux użat għand jintrema ladarba jiġi kompletat it- trattament.
If you use more REGRANEX than you should:
Jekk tuża REGRANEX aktar milli suppost għandek:
If you accidentally apply too much REGRANEX, it is unlikely to do you any harm.
Jekk aċċidentalment tapplika wisq REGRANEX, mhux probabbli li għandu jagħmillek ħsara.
However, always try to exactly follow the instructions for use.
Iżda dejjem għandek issegwi l- istruzzjonijiet għall- użu b’ eżattezza.
Like all medicines, REGRANEX can have side effects.
Bħall- kull mediċina oħra, REGRANEX jista ’ jkollu effetti oħra.
The following conditions were reported during clinical trials of REGRANEX therapy: infection (including skin and bone infection), skin ulceration and skin disorders (including redness and pain).
Il- kundizzonijiet segwenti ġew irrapurtati waqt provi kliniċi ta ’ terapija b ’ REGRANEX: infezzjoni (inkluż infezzjoni tal- ġilda jew tal- għadam), ulċerazzjoni tal- ġilda u mard tal- ġilda (inkluż ħmura u uġigħ).
Blisters and swelling were reported rarely.
Nfafet u nefħa ġew irrapurtati rarament.
Cases of excessive production of tissue in the ulcer due to an exaggerated healing response have rarely been observed in patients receiving REGRANEX.
Każijiet ta ’ produzzjoni eċċesiva ta ’ tessut fl- ulċera minħabba reazzjoni esaġerata ta ’ fejqan ġew osservati rarament f’ pazjenti jirċievu REGRANEX.
If you start to feel unwell or notice any undesirable effects including effects not mentioned in this leaflet or if you are unsure about the effect of this product, do not hesitate to contact your doctor or pharmacist.
Jekk tibda tħossok ma tiflaħx jew tinduna b ’ xi effetti mhux mixtieqa inklużi effetti oħrajn li mhux imniżżlin f’ dan il- fuljett jew jekk m’ intix ċert fuq l- effett ta ’ dan il- prodott jekk jogħġbok għarraf lit - tabib jew lill- ispiżjar tiegħek.
STORING REGRANEX
KIF TAĦŻEN REGRANEX
Close the tube tightly after each use.
Għalaq it- tubu sewwa wara kull użu.
Do not use your medicine after the expiry date (MM/ YY) as indicated on the tube and the outer carton.
M’ għandekx tuża l- mediċina wara d- data ta ’ skadenza (XX/ SS) li tidher fuq it- tubu u l- kartuna ta ’ barra.
Pfarrgasse 75 A-1232 Wien Tel: +43 1 610 300
Österreich JANSSEN- CILAG Pharma GmBH Pfarrgasse 75 A- 1232 Wien Tel: +43 1 610 300
What is Relistor?
X’ inhu Relistor?
Relistor is a medicine that contains the active substance methylnaltrexone bromide.
Relistor huwa mediċina li fiha s- sustanza attiva methylnaltrexone bromide.
It is available as a solution for injection containing 12 mg methylnaltrexone bromide in 0.6 ml.
Jiġi bħala soluzzjoni għall - injezzjoni li fiha 12 mg methylnaltrexone bromide f’ 0. 6 ml.
What is Relistor used for?
Għalxiex jintuża Relistor?
Relistor is used to treat the constipation caused by opioids (painkillers that are related to morphine) in adults who are very ill and are receiving palliative care (treatment of the symptoms of a disease that is not intended to lead to cure).
Relistor jintuża fit- trattament ta ’ l- istitikezza kkawżata minn oppjojdi (taffejja ta ’ l- uġigħ li huma relatati mal- morfina) f’ adulti li huma morda ħafna u li qegħdin jirċievu trattament li jnaqqas l- uġigħ (trattament tas- sintomi ta ’ marda li mhijiex maħsuba li twassal għall- kura).
It is used when the response to the usual laxative medicines has not been sufficient.
Jintuża meta r- rispons għall- mediċini lassattivi normali ma jkunx biżżejjed.
How is Relistor used?
Kif jintuża Relistor?
Relistor is given as an injection under the skin, once every two days.
Relistor jingħata bħala injezzjoni taħt il- ġilda, darba kull jumejn.
The dose depends on the patient’ s body weight, and should be reduced in patients who have severe problems with their kidneys.
Id- doża tiddependi fuq il- piż tal - ġisem tal- pazjent, u għandha titnaqqas f’ pazjenti li għandhom problemi severi fil- kliewi.
It is not recommended for patients who have very severe problems with their kidneys that requires dialysis or severe liver problems.
Mhuwiex rakkomandat għall- pazjenti li għandhom problemi severi ħafna fil- kliewi li jeħtieġu dijaliżi jew li għandhom problemi severi fil- fwied.
Patients can inject themselves once they have been trained appropriately.
Il- pazjenti jistgħu jinjettaw lilhom infushom ladarba jkunu ġew imħarrġa jagħmlu dan kif xieraq.
How does Relistor work?
Kif jaħdem Relistor?
Opioids relieve pain by attaching to ‘ opioid receptors ’ in the brain and spinal cord.
L- opjojdi jtaffu l- uġigħ billi jeħlu ma ’ ‘ riċetturi ta ’ l- opjojdi ’ fil- moħħ u fis- sinsla.
These receptors are also found in the gut.
Dawn ir- riċetturi jinsabu wkoll fl- imsaren.
The active substance in Relistor, methylnaltrexone bromide, is a mu-opioid receptor antagonist.
Meta l- opjojdi jeħlu mar- riċetturi ta ’ l- imsaren, il- mobilità ta ’ l- imsaren tonqos, u dan iwassal għal stitikezza Is- sustanza attiva f’ Relistor, methylnaltrexone bromide, hija antagonista ta ’ riċettur mu- opjojde.
This means that it blocks a specific type of opioid receptor called the ‘ mu-opioid receptor’.
Dan ifisser li timblokka tip speċifiku ta ’ riċettur opjojde msejjaħ ‘ riċettur mu- opjojde ’.
Methylnaltrexone bromide is derived from naltrexone, a well-known substance that is used to block the action of opioids.
Methylnaltrexone bromide huwa miksub minn naltrexone, sustanza magħrufa sewwa li tintuża biex timblokka l- azzjoni ta ’ l- opjojdi.
In contrast to naltrexone, methylnatrexone bromide is less able to enter the brain, meaning that it blocks the mu-opioid receptors in the gut but not in the brain.
B’ kuntrast għal naltrexone, methylnatrexone bromide huwa inqas kapaċi jidħol fil- moħħ, u dan ifisser li jimblokka r- riċetturi mu- opjojdi fl- imsaren iżda mhux fil- moħħ.
By blocking these receptors, Relistor reduces the constipation due to opioids, but does not interfere with their painkilling effects.
Billi jimblokka dawn ir- riċetturi, Relistor inaqqas l- istitikezza dovuta għall- opjojdi, iżda ma jinterferixxix ma ’ l- effetti ta ’ taffija ta ’ l- uġigħ tagħhom.
Relistor was studied in two main studies in a total of 288 patients with an advanced illness and constipation caused by opioids.
Relistor ġie studjat f’ żewġ studji prinċipali fuq total ta ’ 288 pazjent b’ marda avvanzata u bi stitikezza kkawżata minn opjojdi.
Both studies compared the effectiveness of Relistor with that of placebo (a dummy treatment) in stimulating the bowel to open.
Iż- żewġ studji qabblu l- effikaċja ta ’ Relistor ma ’ dak ta ’ plaċebo (trattament finta) fl- istimulazzjoni ta ’ l- imsaren biex jiftħu.
The main measure of effectiveness in both studies was the number of patients whose bowel opened within four hours of the first dose.
Il- kejl ewlieni ta ’ l- effikaċja fiż- żewġ studji kien in - numru ta ’ pazjenti li l- imsaren tagħhom infetħu fi żmien erba ’ sigħat mill- ewwel doża.
The second study also looked at the number of patients whose bowels opened at least twice within four hours of the first four doses.
It- tieni studju ħares ukoll lejn numru ta ’ pazjenti li l- imsaren tagħhom infetħu għal talanqas darbtejn fi żmien erba ’ sigħat mill- ewwel erba ’ dożi.
What benefit has Relistor shown during the studies?
Liema benefiċċju wera Relistor waqt l- istudji mwettqa?
Relistor was more effective than placebo in stimulating the bowels to open.
Relistor kien iktar effikaċi minn plaċebo fl- istimulazzjoni ta ’ l- imsaren biex jiftħu.
In the two studies taken together, 55% of the patients receiving Relistor opened their bowels within four hours after first injection (91 out of 165), compared with 15% of the patients receiving placebo (18 out of 123).
Fiż- żewġ studji meħudin flimkien, 55% tal- pazjenti li rċevew Relistor fetħu l- imsaren tagħhom fi żmien erba ’ sigħat wara l- ewwel injezzjoni (91 minn 165), meta mqabbel ma ’ 15% tal- pazjenti li rċevew plaċebo (18 minn 123).
In the second study, 52% of the patients receiving Relistor opened their bowels at least twice within four hours of the first four doses (32 out of 62), compared with 8% of those receiving placebo (6 out of 71).
Fit- tieni studju, 52% tal- pazjenti li rċevew Relistor fetħu l- imsaren tagħhom għal talanqas darbtejn fi żmien erba ’ sigħat mill- ewwel erba ’ dożi (32 minn 62), meta mqabbel ma ’ 8% ta ’ dawk li kienu qegħdin jirċievu plaċebo (6 minn 71).
What is the risk associated with Relistor?
X’ inhu r- riskju assoċjat ma ’ Relistor?
The most common side effects with Relistor (seen in more than 1 patient in 10) are abdominal (tummy) pain, nausea (feeling sick), flatulence (wind) and diarrhoea.
L- iktar effetti sekondarji komuni ta ’ Relistor (li jidhru f’ aktar minn pazjent 1 minn kull 10) huma uġigħ addominali (taż- żaqq), nawżea (dardir), gass u dijarrea.
For the full list of all side effects reported with Relistor, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rappurtati b’ Relistor, ara l- Fuljett ta' Tagħrif.
Relistor should not be used in people who may be hypersensitive (allergic) to methylnaltrexone bromide or any of the other ingredients.
Relistor ma għandux jintuża f’ nies li jista ’ jkollhom sensittività eċċessiva (allerġiċi) għal methylnaltrexone bromide jew għal kwalunkwe sustanza oħra tiegħu.
It should also not be used in patients whose bowel is blocked or who have a condition that needs immediate bowel surgery.
Ma għandux jintuża wkoll f’ pazjenti li l- imsaren tagħhom huma mblukkati jew li għandhom kundizzjoni li teħtieġ kirurġija immedjata fuq l- imsaren.
Why has Relistor been approved?
Għaliex ġie approvat Relistor?
The Committee for Medicinal Products for Human Use (CHMP) decided that Relistor’ s benefits are greater than its risks for the treatment of opioid-induced constipation in advanced illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Relistor huma ikbar mir- riskji tiegħu għat- trattament ta ’ stitikezza indotta minn opjojdi f’ pazjenti b’ mard avvanzat li jkunu qegħdin jirċievu trattament ta ’ taffija ta ’ l- uġigħ meta r- rispons għal terapija lassattiva normali ma kienx biżżejjed.
The Committee recommended that Relistor be given marketing authorisation.
Il- Kumitat irrakkomanda li Relistor jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Relistor:
Informazzjoni oħra dwar Relistor:
The European Commission granted a marketing authorisation valid throughout the European Union for Relistor to Wyeth Europa Limited on 02 July 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq madwar l- Unjoni Ewropea, għal Relistor lil Wyeth Europa Limited fi 02 ta ’ Lulju 2008.
The full EPAR for Relistor can be found here.
L- EPAR sħiħ għal Relistor jista ’ jiġi kkonsultat hawn.
EU Procedure number Invented name Strength
Numru tal- proċedura ta ’ l- EU
Pharmaceutical Form
Isem inventat Qawwa
12 mg/ 0.6 ml
12 mg/ 0. 6 ml Soluzzjoni għall- injezzjoni
Solution for injection.
Użu għal taħt il- ġilda
Subcutaneous use Vial (glass)
Kunjett (ħġieġ)
0.6 ml (20 mg/ ml)
0. 6 ml (20 mg/ ml)
1 vial
Kunjett
Solution for injection
Użu għal taħt il- ġilda
2 vials + 2 sterile syringes + 4 alcohol swabs
2 kunjetti + 2 siringi sterili + 4 imsiħ ta ’ l - alkoħol
7 vials + 7 sterile syringes + 14 alcohol swabs
7 kunjetti+ 7 siringi sterili + 14 - il msiħ ta ’ l- alkoħol
RELISTOR 12 mg / 0.6 ml solution for injection.
RELISTOR 12 mg / 0. 6 ml soluzzjoni għall- injezzjoni.
Each vial of 0.6 ml contains 12 mg methylnaltrexone bromide.
Kull kunjett ta ’ 0. 6 ml fih 12 mg methylnaltrexone bromide.
One ml of solution contains 20 mg methylnaltrexone bromide.
Millilitru wieħed fih 20 mg methylnaltrexone bromide.
Sterile, clear solution, colourless to pale-yellow, essentially free from visible particulates.
Soluzzjoni sterili, ċara, mingħajr kulur li tkanġi f’ isfar pallidu, essenzjalment ħielsa minn frak viżibbli.
Treatment of opioid-induced constipation in advanced illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient.
Trattament għal stitikezza minħabba opjojdi f’ pazjenti b’ mard avvanzat li qed jirċievu kura palljattiva meta r- rispons għal terapija li ġeneralment tingħata b’ purganti ma jkunx biżżejjed.
For adults only.
Għal adulti biss
RELISTOR should be added to induce prompt bowel movements when response to usual laxative therapy has been insufficient.
RELISTOR għandu jiġi miżjud sabiex jinduċi movimenti fl- imsaren meta rispons għal terapija li ġeneralment tingħata b’ purganti ma jkunx biżżejjed.
The recommended dose of methylnaltrexone bromide is 8 mg (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 rakkomandata ta ’ methylnaltrexone bromide hi ta ’ 8 mg (0. 4 ml RELISTOR) (għal pazjenti li jiżnu 38- 61 kg) jew 12 mg (0. 6 ml RELISTOR) (għal pazjenti li jiżnu bejn 62- 114 kg).
The usual administration schedule is one single dose every other day.
L- iskeda tad- doża li ġeneralment tingħata hi dik ta ’ doża waħda ġurnata iva u ġurnata le.
Doses may also be given with longer intervals, as per clinical need.
Id- dożi jistgħu jingħataw b’ intervalli itwal skond il- ħtieġa klinika.
Patients may receive two consecutive doses 24 hours apart, only when there has been no response (bowel movement) to the dose on the preceding day.
Il- pazjenti jistgħu jirċievu żewġ dożi konsekuttivi li jkunu 24 siegħa bejnithom biss meta ma jkunx hemm rispons (moviment ta ’ l- imsaren) għad- doża li tkun ingħatat fil- jum ta ’ qabel.
Patients whose weight falls outside of the ranges should be dosed at 0.15 mg/ kg.
Il- pazjenti li l- piż tagħhom jaqa ’ lil hinn mill- meded mogħtija għandhom jiġu dożati b’ 0. 15 mg/ kg.
The injection volume for these patients should be calculated:
Il- volum injettat għal dawn il- pazjenti għandu jiġi kkalkulat:
Dose (ml) = patient weight (kg) x 0.0075
Doża (ml) = piż tal- pazjent (kg) x 0. 0075
Renal patients In patients with severe renal impairment (creatinine clearance less than 30 ml/ min), the dose of methylnaltrexone bromide should be reduced from 12 mg to 8 mg (0.4 ml RELISTOR) for those weighing 62 to 114 kg, or from 0.15 mg/ kg to 0.075 mg/ kg for those whose weight falls outside the 62 to 114 kg range (see section 5.2).
2 Pazjenti bi problemi tal- kliewi F’ pazjenti li għandhom indeboliment renali sever (tneħħija ta ’ kreatinina ta ’ inqas minn 30 ml/ min), id- doża ta ’ methylnaltrexone bromide għandha titnaqqas minn 12 mg għal 8 mg (0. 4 ml RELISTOR) għal dawk li jiżnu bejn 62 sa 114 kg, jew minn 0. 15 mg/ kg għal 0. 075 mg/ kg għal dawk li l- piż tagħhom jaqa ’ barra mill- medda ta ’ 62 sa 114 kg (ara sezzjoni 5. 2).
There are no data available from patients with end-stage renal impairment on dialysis, and RELISTOR is not recommended in these patients (see section 4.4).
M’ hemmx tagħrif disponibbli minn pazjenti b’ indeboliment renali fil- fażi terminali fuq dijaliżi, u RELISTOR mhux rakkomandat f’ dawn il- pazjenti (ara sezzjoni 4. 4).
2 Hepatic impairment No dose adjustment is necessary in patients with mild to moderate hepatic impairment (see section 5.2).
Indeboliment epatiku L- ebda aġġustament fid- doża mhu meħtieġ f’ pazjenti li għandhom indeboliment epatiku minn ħafif sa moderat (ara sezzjoni 5. 2).
There are no data available from patients with severe hepatic impairment (Child-Pugh Class C), and RELISTOR is not recommended in these patients (see section 4.4).
M’ hemmx tagħrif disponibbli minn pazjenti li għandhom indeboliment epatiku sever (Child- Pugh Class C), u RELISTOR mhux rakkomandat f’ dawn il- pazjenti (ara sezzjoni 4. 4).
Paediatric patients There is no experience in children under the age of 18 (see section 5.2).
Pazjenti tfal M’ hemmx esperjenza dwar l- użu fit- tfal li għandhom inqas minn 18- il sena (ara sezzjoni 5. 2).
Therefore, methylnaltrexone should not be used in the paediatric age group until further data become available.
Għalhekk, methylnaltrexone m’ għandux jingħata lil tfal li qegħdin f’ din l- età pedjatrika sakemm aktar informazzjoni tkun disponibbli.
Elderly patients No dose adjustment is recommended based on age (see section 5.2).
Pazjenti anzjani L- ebda aġġustament tad- doża mhu rakkomandat skond l- età (ara sezzjoni 5. 2).
Administration
Għoti
RELISTOR is given as a subcutaneous injection.
RELISTOR għandu jingħata bħala injezzjoni taħt il- ġilda.
It is recommended to rotate injection sites.
Huwa rakkomandat li s- siti ta ’ injezzjoni jiġu mdawwra.
It is not recommended to inject into areas where the skin is tender, bruised, red, or hard.
Tinjettax f’ siti fejn il- ġilda tkun ratba, mbenġla, ħamra jew iebsa.
Areas with scars or stretch marks should be avoided.
Siti bi tbajja ’ jew sinjali ta ’ twessigħ għandhom jiġu evitati.
The three areas of the body recommended for injection of RELISTOR are upper legs, abdomen, and upper arms.
It- tliet postijiet fil- ġisem li huma rakkomandati li fihom tingħata l- injezzjoni ta ’ RELISTOR huma fil- koxox, l - addome u fil- parti ta ’ fuq tad- dirgħajn.
RELISTOR can be injected without regard to food.
RELISTOR jista ’ jiġi injettat mingħajr konsiderazzjoni għal ikel.
Use of methylnaltrexone bromide in patients with known or suspected mechanical gastrointestinal obstruction or acute surgical abdomen is contraindicated.
L- użu ta ’ methylnaltrexone bromide f’ pazjenti li għandhom sadd mekkaniku intestinali magħruf jew suspettat jew addome kirurġika akuta huwa kontra- indikat.
The activity of methylnaltrexone bromide has been studied in patients with constipation induced by opioids.
L- attività ta ’ methylnaltrexone bromide ġiet studjata f’ pazjenti bi stitikezza kkaġunata minħabba opjojdi.
Therefore, RELISTOR should not be used for treatment of patients with constipation not related to opioid use.
Għalhekk, RELISTOR m’ għandux jintuża fit- trattament ta ’ pazjenti bi stitikezza mhux relatata ma ’ l- użu ta ’ opjojdi.
If severe or persistent diarrhoea occurs during treatment, patients should be advised not to continue therapy with RELISTOR and consult their physician.
Kemm- il darba jkun hemm dijarea severa jew persistenti waqt it- trattament, il- pazjenti għandhom jiġu avżati biex ma jkomplux jieħdu t- terapija b’ RELISTOR u jikkonsultaw it- tabib tagħhom.
Data from clinical trials suggest treatment with methylnaltrexone bromide can result in the rapid onset (within 30 to 60 minutes on average) of a bowel movement.
Tagħrif minn provi kliniċi jissuġġerixxi li t- trattament b’ methylnaltrexone bromide jista ’ jikkaġuna ċaqlieq ta ’ malajr (fi żmien minn 30 sa 60 minuta) fl- imsaren.
Methylnaltrexone bromide treatment has not been studied in clinical trials for longer than 4 months, and should therefore only be used for a limited period (see section 5.2).
3 It- trattament b’ methylnaltrexone bromide ma ġiex studjat fil- provi kliniċi għal aktar minn 4 xhur u għalhekk għandu jintuża biss għal perijodu limitat (ara sezzjoni 5. 2).
RELISTOR should only be used in patients who are receiving palliative care.
RELISTOR għandu jintuża biss f’ pazjenti li qed jirċievu kura palljattiva.
It is added to usual laxative treatment.
Huwa ġeneralment jiġi miżjud ma ’ trattament purganti.
RELISTOR is not recommended in patients with severe hepatic impairment or with end-stage renal impairment requiring dialysis (see section 4.2).
RELISTOR mhux rakkomandat lil pazjenti b’ indeboliment epatiku sever jew b’ indeboliment renali ta ’ l- aħħar fażi li jeħtieġ dijaliżi (ara sezzjoni 4. 2).
Use of methylnaltrexone bromide in patients with colostomy, peritoneal catheter, active diverticular disease or fecal impaction has not been studied.
L- użu ta ’ methylnaltrexone bromide f’ pazjenti b’ kolostomija, kateter peritoneali, mard divertikulari attiv jew sadd bl- ippurgar ma ġiex studjat.
Therefore, RELISTOR should only be administered with caution in these patients.
Għalhekk, RELISTOR għandu jingħata b’ kawtela f’ dawn il- pazjenti.
3 This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i. e., essentially sodium- free).
Dan il- prodott mediċinali fih inqas minn 1 mmol ta ’ sodju (23 mg) f’ kull doża, i. e essenzjalment mingħajr sodju.
Methylnaltrexone does not affect the pharmacokinetics of medicinal products metabolised by cytochrome P450 (CYP) isozymes.
Methylnaltrexone ma jaffettwax il- farmakokinetiċi ta ’ prodotti mediċinali oħra metabolizzati bl- isoenzimi P450 (CYP) ta ’ cytochrome.
Methylnaltrexone is minimally metabolised by CYP isozymes.
Methylnaltrexone huwa metabolizzat mill- inqas b’ isoenzimi CYP.
In vitro metabolism studies suggest that methylnaltrexone does not inhibit the activity of CYP1A2, CYP2E1, CYP2B6, CYP2A6, CYP2C9, CYP2C19 or CYP3A4, while it is a weak inhibitor of the metabolism of a model CYP2D6 substrate.
Studji dwar il- metaboliżmu in vitro jissuġġerixxu li methylnaltrexone ma jimpedixxiex l- attività ta ’ CYP1A2, CYP2E1, CYP2B6, CYP2A6, CYP2C9, CYP2C19 jew CYP3A4, filwaqt li hu impeditur dgħajjef tal- metaboliżmu ta ’ mudell tas- substrat CYP2D6.
In a clinical drug interaction study in healthy adult male subjects, a subcutaneous dose of 0.3 mg/ kg of methylnaltrexone did not significantly affect the metabolism of dextromethorphan, a CYP2D6 substrate.
Fi studju dwar l- effett tal- mediċina jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku f’ individwi rġiel adulti, doża ta ’ 0. 3 mg/ kg ta ’ methylnaltrexone mogħtija taħt il- ġilda m’ affettwatx b’ mod sinifikanti l- metaboliżmu ta ’ dextromethorphan, substrat ta ’ CYP2D6.
The organic cation transporter (OCT)-related drug-drug interaction potential between methylnaltrexone and an OCT inhibitor was studied in 18 healthy subjects by comparing the single- dose pharmacokinetic profiles of methylnaltrexone before and after multiple 400 mg doses of cimetidine.
Il- potenzjal ta ’ l- effett tal- mediċina ma ’ mediċina relatata mat- trasportatur katajoniku organiku (OCT) bejn methylnaltrexone u impeditur OCT ġie studjat fi 18- il pazjent b’ saħħithom billi ġew mqabbla l- profili farmakokinetiċi ta ’ doża waħda ta ’ methylnaltrexone qabel u wara li ngħataw dożi multipli ta ’ 400 mg cimetidine.
The renal clearance of methylnaltrexone was reduced following multiple-dose administration of cimetidine (from 31 l/ h to 18 L/ h).
It- tneħħija mill- kliewi ta ’ methylnaltrexone tnaqqset wara l- għoti f’ dożi multipli ta ’ cimetidine (minn 31 l/ h sa 18 l/ h).
However, this resulted in a small reduction in total clearance (from 107 L/ h to 95 l/ h).
Madankollu dan jirriżulta fi tnaqqis żgħir mit- tneħħija totali (minn 107 l/ h sa 95 l/ h).
Consequently, no meaningful change in AUC of methylnaltrexone, in addition to Cmax, was observed before and after multiple-dose administration of cimetidine.
Konsegwentement, ma kien hemm ebda bidla notevoli osservata fl- AUC ta ’ methylnaltrexone, barra minn dak ta ’ Cmax, qabel u wara l- għoti ta ’ dożi multipli ta ’ cimetidine.
Pregnancy There are no adequate data with the use of methylnaltrexone bromide in pregnant women.
Tqala M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ methylnaltrexone bromide waqt it- tqala.
Studies in animals have shown reproductive toxicity at high doses (see section 5.3).
Studji fuq bhejjem urew ħsara fuq is- sistema riproduttiva f’ dożi għoljin (ara sezzjoni 5. 3).
RELISTOR should not be used during pregnancy unless clearly necessary.
RELISTOR m’ għandux jintuża waqt it- tqala jekk m’ hemmx bżonn ċar.
Lactation It is unknown whether methylnaltrexone bromide is excreted in human breast milk.
Treddigħ Mhux magħruf jekk methylnaltrexone bromide jiġix eliminat fil- ħalib ta ’ l- omm.
Animal studies have shown excretion of methylnaltrexone bromide in breast milk.
Studji fuq l- annimali indikaw il- preżenza ta ’ methylnaltrexone bromide fil- ħalib ta ’ l- omm.
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy with RELISTOR should be made, taking into account the benefit of breast-feeding to the child and the benefit of RELISTOR therapy to the woman.
Deċiżjoni jekk għandekx tkompli/ twaqqaf it - terapija b’ RELISTOR għandha tittieħed skond il- benefiċċju li l- wild qed jieħu mit- treddigħ u l- benefiċċju tat- terapija b’ RELISTOR fuq il- mara.
No studies on the effects on the ability to drive and use machines have been performed.
Jista ’ jkun hemm sturdamenti, u dan jista ’ jkollu effett fuq il- ħila biex issuq u tħaddem magni.
However, as a pure peripherally restricted opioid antagonist, the likelihood that methylnaltrexone will affect such activities is low.
(see section 4. 8).
The most common drug-related adverse reactions in all patients exposed to methylnaltrexone bromide during all phases of placebo-controlled studies were abdominal pain, nausea, diarrhoea and flatulence.
L- aktar effetti komuni avversi relatati mal- mediċina fil- pazjenti kollha esposti għal methylnaltrexone bromide waqt il- fażijiet kollha ta ’ l- istudji bi plaċebos bħala kontrolli kienu uġigħ addominali, nawseja, dijarea u gass.
Generally, these reactions were mild or moderate.
Ġeneralment, dawn ir- reazzjonijiet kienu ħfief jew moderati.
The adverse reactions are classified as:
Ir- reazzjonijiet avversi huma klassifikati bħala:
Very common (≥ 1/ 10); Common (≥ 1/ 100 to < 1/ 10); Uncommon (≥ 1/ 1,000 to < 1/ 100); Rare (≥ 1/ 10,000 to < 1/ 1,000); Very rare (< 1/ 10,000), unknown (cannot be estimated from the available data).
Komuni ħafna (≥1/ 10); Komuni (≥1/ 100 sa < 1/ 10); Mhux komuni (≥1/ 1, 000 sa < 1/ 100); Rari (≥1/ 10, 000 sa < 1/ 1, 000); Rari ħafna (< 1/ 10, 000), mhux magħruf (ma jistax jiġi stmat mit- tagħrif disponibbli).
4 Gastrointestinal disorders Very common:
Disturbi gastro- intestinali Komuni ħafna:
Abdominal pain, nausea, flatulence, diarrhoea
Uġigħ addominali, nawseja, gass, dijarea
Skin and subcutaneous tissue disorders Common:
u fit- tessuti ta ’ taħt il- ġilda
Injection site reactions (e. g. stinging, burning, pain, redness, oedema)
Komuni: reazzjonijiet fis- sit ta ’ l- injezzjoni (eż. tingiż, ħruq, uġigħ, ħmura, edema)
No case of overdose has been reported during clinical trials.
L- ebda każ ta ’ doża eċċessiva ma ġie rrappurtat waqt il- provi kliniċi.
A study of healthy volunteers noted orthostatic hypotension associated with a dose of 0.64 mg/ kg administered as an intravenous bolus.
Studju ta ’ voluntieri b’ saħħithom innota ipotensjoni ortostatika assoċjata ma ’ doża ta ’ 0. 64 mg/ kg mogħtija bħala bolus ghal ġol- vini.
In the event of an overdose, signs and symptoms of orthostatic hypotension should be monitored and reported to a physician.
F’ każ ta ’ doża eċċessiva, is- sinjali u s- sintomi ta ’ ipotensjoni ortostatika għandhom jiġu monitorati u rapportati lil tabib.
Treatment should be initiated as appropriate.
It- trattament għandu jibda kif jixraq.
Pharmacotherapeutic group: not yet assigned, ATC code: not yet assigned.
Kategorija farmakoterapewtika: għadu mhux assenjat, Kodiċi ATC: għadu mhux assenjat.
Mode of action Methylnaltrexone bromide is a selective antagonist of opioid binding at the mu-receptor.
Kif jaħdem Methylnaltrexone bromide huwa antagonist selettiv ta ’ opjojdi li jintrabat fir- riċettatur- mu.
In vitro studies have shown methylnaltrexone to be a mu-opioid receptor antagonist (inhibition constant [Ki] = 28 nM), with 8-fold less potency for kappa opioid receptors (Ki = 230 nM) and much reduced affinity for delta opioid receptors.
Studji in vitro wrew li methylnaltrexone huwa riċettatur antagonista ta ’ mu- opjojdi (konstant ta ’ l- inibizzjoni [Ki] = 28 nM), b’ potenza ta ’ 8 darbiet inqas għal riċettaturi opjojdi kappa (Ki = 230 nM) u b’ affinità mnaqqsa ħafna għal riċettaturi opjojdi delta.
As a quaternary amine, the ability of methylnaltrexone to cross the blood-brain barrier is restricted.
Bħala ammina kwartenarja, l- abbilità ta ’ methylnaltrexone biex jaqsam il- barriera tad- demm għal moħħ hija ristretta.
This allows methylnaltrexone to function as a peripherally acting mu-opioid antagonist in tissues such as the gastrointestinal tract, without impacting opioid-mediated analgesic effects on the central nervous system.
Dan jippermetti lil methylnaltrexone biex jiffunzjona bħala antagonist fuq il- mu- opjojdi f’ tessuti bħall - apparat gastro- intestinali, mingħajr ma jagħmel impatt fuq l- effetti analġeżiċi li jsiru permezz ta ’ opjojdi fuq is- sistema nervuża ċentrali.
Clinical efficacy and safety The efficacy and safety of methylnaltrexone bromide in the treatment of opioid-induced constipation in patients receiving palliative care was demonstrated in two randomised, double-blind, placebo-controlled studies.
5 Effikaċja klinika u sigurtà L- effikaċja u s- sigurtà ta ’ methylnaltrexone bromide fit- trattament ta ’ stitikezza ikkaġunata minħabba opjojdi f’ pazjenti li qed jirċievu kura palljativa ġew murija f’ żewġ studji randomised, double blind, li saru bi plaċebos bħala kontroll.
In these studies, the median age was 68 years (range 21-100); 51% were females.
F’ dawn l- istudji, l- età medjana kienet ta ’ 68 sena (fuq medda ta ’ 21- 100); 51% kienu nisa.
In both studies, patients had advanced terminal illness and limited life expectancy, with the majority having a primary diagnosis of incurable cancer; other primary diagnoses included end-stage COPD/ emphysema, cardiovascular disease/ heart failure, Alzheimer’ s disease/ dementia, HIV/ AIDS, or other advanced illnesses.
Fiż - żewġ studji, il- pazjenti kellhom mard terminali avvanzat u stennija ta ’ ħajja limitata, bil- maġġoranza jkollhom dijanjosi primarja ta ’ kanċer li ma jfieqx; dijanjosi primarji oħrajn kienu jinkludu COPD/ emfisema, mard kardjovaskulari/ insuffiċjenza tal- qalb, marda ta ’ Alzheimer/ dimenzja, HIV/ AIDS, jew mard avvanzat ieħor.
Prior to screening, patients had opioid-induced constipation defined as either< 3 bowel movements in the preceding week or no bowel movement for > 2 days.
Qabel ma ġew skrinjati, il- pazjenti kellhom stitikezza kaġunata minn opjojdi mfissra bħala jew jippurgaw < 3 darbiet fil- ġimgħa ta ’ qabel jew ma jippurgaw xejn għal > 2 ijiem.
Study 301 compared methylnaltrexone bromide given as a single, double-blind, subcutaneous dose of 0.15 mg/ kg, or 0.3 mg/ kg versus placebo.
L- istudju 301 ipparaguna methylnaltrexone bromide mogħti b’ doża waħda double- blind li tingħata taħt il- ġilda ta ’ 0. 15 mg/ kg jew 0. 3 mg/ kg,, mal- plaċebo.
The double-blind dose was followed by an open-label, 4-week dosing period, where methylnaltrexone bromide could be used as needed, no more frequently than 1 dose in a 24-hour period.
Id- doża double- blind kienet segwita minn perijodu ta ’ dożaġġ fuq 4 ġimgħat, meta methylnaltrexone bromide seta ’ jiġi wżat kif meħtieġ, b’ mhux aktar minn doża waħda f’ perijodu ta ’ 24 siegħa.
Throughout both study periods, patients maintained their usual laxative regimen.
Matul iż- żewġ perijodi ta ’ studju, il- pazjenti baqgħu bl- istess programm ta ’ mediċina purganti, imma rescue laxatives kienu pprojbiti minn 4 sigħat qabel sa 4 sigħat wara kull injezzjoni ta ’ studju mediċinali.
A total of 154 patients (methylnaltrexone bromide 0.15 mg/ kg, n=47, methylnaltrexone bromide 0.3 mg/ kg, n=55, placebo, n=52) were treated in the double-blind period.
Total ta ’ 154 pazjent (methylnaltrexone bromide 0. 15 mg/ kg, n=47, methylnaltrexone bromide 0. 3 mg/ kg, n=55, plaċebo, n=52) kienu trattati fil- perijodu double- blind.