qanastek/EMEA-V3 huggingface dataset:
Patients taking anti-arrhythmic medications for the control of arrhythmias and anti-seizure medications for the control of seizure disorders were excluded from clinical trials.
Pazjenti li kienu qed jieħdu mediċini anti- arritmiċi għal kontroll ta ’ arritmiji u mediċini kontra l - puplesijagħal kontroll ta ’ disturbi marbuta mal- puplesija ġew esklużi fil- provi kliniċi.
Peritonitis is a known complication in patients receiving peritoneal dialysis (PD) and in a clinical study with Renagel, a number of peritonitis cases were reported.
Il- peritonite hija kumplikazzjoni magħrufa f’ pazjenti li qed jirċievu dijaliżi peritoneali u fi studju kliniku b’ Renagel, għadd ta ’ każijiet ta ’ peritonite ġew rapportati.
Therefore, patients on PD should be closely monitored to ensure the reliable use of appropriate aseptic technique with the prompt recognition and management of any signs and symptoms associated with peritonitis.
Għalhekk, pazjenti b’ PD għandhom jiġu sorveljati mill- qrib sabiex jiġi żgurat l- użu afidabbli tat- teknika asettika xierqa bl - għarfien żvelt u l- ġestjoni ta ’ xi sinjali u sintomi assoċjati ma ’ peritonite.
As data on the chronic use of sevelamer for over one year are not yet available, potential absorption and accumulation of sevelamer during long-term chronic treatment cannot be totally excluded (see section 5.2 Pharmacokinetics).
Peress li għad m’ hemmx data fuq l- użu kroniku ta’ sevelamer fuq perjodu ta ’ aktar minn sena, l - assorbiment u l- akkumulazzjoni potenzjali ta ‘ sevelamer matul il- kura kronika fuq perijodu twil ta ’ żmien ma jistgħux ikunu kompletament esklużi (ara sezzjoni 5. 2 Tagħrif farmakokinetiku).
However, the bioavailability of ciprofloxacin was decreased by approximately 50% when co-administered with Renagel in a single dose study.
Imma il- bijodisponibilità ta ’ cipofloxacin tnaqqset b’ madwar 50% meta ingħatat flimkien ma Renagel fi studju ta ’ doża waħda.
No studies on the effects on ability to drive and use machines have been performed.
Ma saru l- ebda studji dwar l- effetti fuq il- ħila ta ’ sewqan u tħaddim ta ’ magni.
Data possibly or probably related to Renagel from these studies (299 patients) and from uncontrolled clinical trials (384 patients) are listed by frequency in the
Dejta li possibilment jew probabilment huma relatati ma ’ Renagel minn dawn l- istudji (299 pazjent) u minn provi kliniċi mingħajr kontrolli (384 pazjent) huma elenkati skond il- frekwenza fit- tabella t’ hawn isfel.
The reporting rate is classified as very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10), uncommon (≥ 1/ 1,000, < 1/ 100), rare (≥ 1/ 10,000, < 1/ 1,000), very rare (< 1/ 10,000), including isolated.
Disturbi gastrointestinali Komuni ħafna (≥1/ 10):
Renagel has been given to normal healthy volunteers in doses up to 14 grams, the equivalent of thirty- five 403 mg capsules (equivalent to seventeen 800 mg tablets), per day for eight days with no undesirable effects.
Renagel ingħata lill- voluntieri normali b’ saħħithom f’ dożi sa 14- il gramma, l- ekwivalent ta ’ ħamsa u tletin pillola 403 mg (ekwivalenti għall- sbatax 800 mg pillola), kuljum għal tmient ijiem mingħajr l - ebda effetti mhux mixtieqa.
Renagel contains sevelamer, a non-absorbed phosphate binding poly(allylamine hydrochloride) polymer, free of metal and calcium.
Il- pilloli Renagel fihom sevelamer, polimer li jgħaqqad poly( alkylamine hydrochloride) mhux assorbit, li ma fihx metal u kalċju.
By binding phosphate in the gastrointestinal tract, sevelamer lowers the phosphate concentration in the serum.
Sevelamer jbaxxi l - konċentrazzjoni ta ’ phosphate fis- serum għax jorbot phosphate fl- apparat gastrointestinali
In clinical trials, selevamer has been shown to be effective in reducing serum phosphorus in patients receiving haemodialysis or peritoneal dialysis.
Fi provi kliniċi selevamer wera li jista ’ jkune effettiv billi jnaqqas il- fosforu fis- serum f’ pazjenti li qed jirċievu emodijaliżi jew dijaliżi peritoneali
Sevelamer has been shown to bind bile acids in vitro and in vivo in experimental animal models.
Sevelamer wera li hu kapaċi jorbot aċidi tal- bile in vitro u in vivo f’ mudelli esperimentali ta ’ l - annimali.
In clinical trials mean total and LDL cholesterol declined by 15-31%.
Fi studji kliniċi l- livell medju tal- kolesterol tat- tip LDL u totali naqas bi 15- 31%.
In the clinical studies in haemodialysis patients, sevelamer alone did not have a consistent and clinically significant effect on serum intact parathyroid hormone (iPTH).
11 Fi studji kliniċi f’ pazjenti li kienu qed jirċievu dijaliżi tad- demm, sevelamer waħdu, biss ma kellux effett konsistenti u klinikalment sinifikanti fuq l- ormon paratirojde intatt fis- serum (iPTH).
11 In a clinical trial of one-year duration, Renagel had no adverse effect on bone turnover or mineralisation compared to calcium carbonate.
Fi prova klinika li damet sejra sena, Renagal ma kellux effett avvers fuq rendiment ta ’ l- għadam jew mineralizzazzjoni meta mqabbel ma ’ calcium carbonate.
The effects may be secondary to vitamin D and/ or vitamin K depletion at these high doses.
L- effetti għandhom mnejn kienu sekondarji għat- tnaqqis tal- vitamini D u/ jew K fil- livell ta ’ dawn id- dożi għoljin.
Iron oxide black (E172) Propylene glycol Hypromellose
Iron oxide black (E172), Propylene glycol Hypromellose.
6.2 Incompatibilities
12 6. 2 Inkompatibilitajiet
Do not store above25ºC.
Taħżinx f’ temperatura ’ l- fuq minn 25°C.
12 Keep the container tightly closed.
Żomm il - kontenitur magħluq sewwa.
High density polyethylene bottles, with a child resistant polypropylene cap and an induction seal.
Flixken ta ’ polyethylene ta’ densità għolja, b’ tap ta ’ polypropylene li ma jistgħux jiftħuh it- tfal b’ siġill ta ’ l- induzzjoni.
800 mg tablets
800 mg pilloli
6 x 30 tablets 1 x 100 tablets 1 x 180 tablets 2 x 180 tablets 3 x 180 tablets
6 x 30 pillola 1 x 100 pillola 1 x 180 pillola 2 x 180 pillola 3 x 180 pillola
Not all pack sizes
Jista ’ jkun li mhux
may be marketed.
il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
Genzyme Europe B. V., Gooimeer 10, 1411 DD Naarden, The Netherlands
Genzyme Europe B. V., Gooimeer 10, 1411 DD Naarden, L- Olanda
13 ANNEX II
13 Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija tal- Mediċini Ewropea (EMEA) http // www. emea. europa. eu.
14 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
14 ANNESS II
Name and address of the manufacturer responsible for batch release
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
Genzyme Limited, 12 Rookwood Way, Haverhill, Suffolk CB9 8PB, United Kingdom
Genzyme Limited, 12 Rookwood Way, Haverhill, Suffolk CB9 8PB, Renju Unit
The MAH commits to performing a registry study and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jimpenja ruħu li jwettaq studju ta ’ reġistru u attivitajiet ta ’ farmakoviġilanza dettaljata fil- Pjan ta ’ Farmakoviġilanza.
An updated Risk Management Plan should be provided as per the CHMP Guideline on Risk Management Systems. for medicinal products for Human Use.
Pjan ta ’ Ġestjoni aġġornat għandu jiġi pprovdut skond il- Linji Gwida ta ’ CHMP dwar is- Sistemi ta ’ Ġestjoni tar- Riskju għal prodotti mediċinali għal- Użu mill- Bniedem.
The MAH will submit 6-montly PSURs unless otherwise specified by the CHMP
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jissottometti PSUR ta ’ kull 6 xhur kemm- il darba ma jiġiex speċifikat mod ieħor mis- CHMP
17 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
TIKKETTA
OUTER CARTON - BOTTLE OF 360 TABLETS 400 mg
KARTUNA TA ’ BARRA - FLIXKUN TA ’ 360 PILLOLA TA ’ 400 mg
Renagel 400 mg film-coated tablets sevelamer
Renagel 400 mg pilloli miksija b’ rita sevelamer
Each tablet contains 400 mg of the sevelamer.
Kull pillola fiha 400 mg ta ’ sevelamer
The tablet also contains iron oxide black (E172) and propylene glycol.
Il- pillola fiha wkoll iron oxide black (E172), u propylene glycol
360 film-coated tablets
360 pillola miksija b’ rita
Tablets must be swallowed whole.
Il- pilloli jridu jinbelgħu sħaħ.
Keep the bottle tightly closed.
Taħżinx f’ temperatura `l fuq minn 25oC Żomm il- kontenitur magħluq sewwa.
19 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
20 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON - 2 BOTTLES OF 360 TABLETS 400 mg
KARTUNA TA ’ BARRA - 2 FLIEXKEN TA ’ 360 PILLOLA TA ’ 400 mg
2 bottles of 360 film-coated tablets
2 fliexken ta ’ 360 pillola miksija b’ rita
Read the package leaflet before use.
Tomgħodhomx Aqra l- fuljett ta ’ tagħrif qabel l- użu.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENTUR ’ TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Renagel 400 mg sevelamer
Renagel 400mg Sevelamer
21 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
22 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON - 3 BOTTLES OF 360 TABLETS 400 mg
KARTUNA TA ’ BARRA - 3 FLIEXKEN TA ’ 360 PILLOLA TA ’ 400 mg
3 bottles of 360 film-coated tablets
3 fliexken ta ’ 360 pillola miksija b’ rita
23 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
24 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
LABEL - BOTTLE OF 360 TABLETS 400 mg
TIKKETTA - FLIXKUN TA ’ 360 PILLOLA TA ’ 400 mg
25 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
26 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON - 6 BOTTLES OF 30 TABLETS 800 mg
KARTUNA TA ’ BARRA - 6 FLIEXKEN TA ’ 30 PILLOLA TA ’ 800 mg
Renagel 800 mg film-coated tablets sevelamer
Renagel 800 mg pilloli miksija b’ rita sevelamer
Each tablet contains 800 mg of the sevelamer.
Kull pillola fiha 800 mg ta ’ sevelamer
6 bottles of 30 film-coated tablets
6 fliexken ta ’ 30 pillola miksija b’ rita
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
28 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON - BOTTLE OF 100 TABLETS 800 mg
KARTUNA TA ’ BARRA - FLIXKUN TA ’ 100 PILLOLA TA ’ 800 mg
100 film-coated tablets
100 pillola miksija b’ rita
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
30 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON - BOTTLE OF 180 TABLETS 800 mg
KARTUNA TA ’ BARRA - FLIXKUN TA ’ 180 PILLOLA TA ’ 800 mg
The tablet also contains iron oxide black (E172) and propylene glycol.
Il- pillola fiha wkoll ossidu tal- ħadid iswed (E172), u propylene glycol
180 film-coated tablets
180 pillola miksija b’ rita Aqra l- fuljett ta ’ tagħrif qabel l- użu
31 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
32 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON - 2 BOTTLES OF 180 TABLETS 800 mg
KARTUNA TA ’ BARRA - 2 FLIEXKEN TA ’ 180 PILLOLA TA ’ 800 mg
2 bottles of 180 film-coated tablets
2 fliexken ta ’ 180 pillola miksija b’ rita
Read the package leaflet before use.
Tomgħodhomx Aqra l- fuljett ta ’ tagħrif qabel l- użu
33 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
34 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON - 3 BOTTLES OF 180 TABLETS 800 mg
KARTUNA TA ’ BARRA - 3 FLIEXKEN TA ’ 180 PILLOLA TA ’ 800 mg
3 bottles of 180 film-coated tablets
3 fliexken ta ’ 180 pillola miksija b’ rita
35 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
36 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
LABEL - BOTTLE OF 30 TABLETS 800 mg
TIKKETTA - FLIXKUN TA ’ 30 PILLOLA TA ’ 800 mg
37 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
38 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
LABEL - BOTTLE OF 100 TABLETS 800 mg
TIKKETTA - FLIXKUN TA ’ 100 PILLOLA TA ’ 800 mg
39 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
40 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
LABEL - BOTTLE OF 180 TABLETS 800 mg WITH OUTER CARTON
TIKKETTA - FLIXKUN TA ’ 180 PILLOLA TA ’ 800 mg B’ KARTUNA TA ’ BARRA
180 film-coated tablets
180 pillola miksija b’ rita
41 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
42 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
LABEL - BOTTLE OF 180 TABLETS 800 mg WITHOUT OUTER CARTON
TIKKETTA - FLIXKUN TA ’ 180 PILLOLA TA ’ 800 mg MINGĦAJR IL- KARTUNA TA ’ BARRA
The tablet also contains iron oxide black (E172) and propylene glycol.
Il- pillola fiha wkoll iron oxide black (E172), u propylene glycol.
Do not store above 25°C.
Taħżinx f’ temperatura `l fuq minn 25oC.
Keep the bottle tightly closed.
Żomm il- kontenitur magħluq sewwa.
Read all of this leaflet carefully before you start taking this medicine.
Aqra sew dan il- fuljett kollu qabel tibda tieħu din il- mediċina Żomm dan il- fuljett.
- If you have further questions, ask your doctor or your pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
It may harm them, even if
-
What Renagel is and what it is used for.
X’ inhu Renagel u għalxiex jintuża.
Before you take Renagel.
Qabel ma ’ tieħu Renagel.
How to take Renagel.
Kif għandek tieħu Renagel.
How to store Renagel.
Kif taħżen Renagel.
WHAT RENAGEL IS AND WHAT IT IS USED FOR
X’ INHU RENAGEL U GĦAL XIEX JINTUŻA
Renagel contains sevelamer as the active ingredient.
Renagel fih sevelamer bħala s- sustanza attiva.
It binds phosphate from food in the digestive tract and so reduces serum phosphate levels in the blood.
Huwa jingħaqad ma ’ fosfat li jiġi mill- ikel fl- apparat diġestiv u għalhekk inaqqas il- livelli ta ’ fosfat fid- demm.
Renagel is used to control the levels of phosphate in the blood of adult kidney failure patients on haemodialysis or peritoneal dialysis treatment.
Renagel jintuża biex jikkontrolla l- livelli ta ’ fosfat fid- demm ta ’ kliewi insuffiċjenti adulti li qegħdin fuq trattament ta ’ dijaliżi tad- demm jew dijaliżi peritoneali.
Episodes of high calcium levels in your blood will therefore be fewer than when calcium tablets alone are taken to regulate your blood phosphate levels.
Għalhekk, episodji ta ’ livelli għoljin ta ’ kalċju fid- demm tiegħek ser ikunu inqas milli meta kont qed tieħu il- pilloli ta ’ kalċju biss biex tirregola l- livelli tal- fosfat.
Renagel also binds bile acids and so reduces the levels of LDL (‘ bad’) cholesterol in your blood.
Renagel jorbot ukoll l- aċidi biljari u għalhekk inaqqas il- livelli ta ’ LDL kolesterol (‘ ħażin ’) f’ demmek.
It may be necessary to use other medicines with Renagel, which could include calcium or vitamin D supplements, to control the development of renal bone disease.
Jista ’ jkun meħtieġ li tuża mediċini oħra ma ’ Renagel, li jistgħu jinkludu supplimenti ta ’ kalċju jew vitamina D, sabiex jiġi kkontrollat il- mard ta ’ l- iżvilupp ta ’ l- għadam renali.
BEFORE YOU TAKE RENAGEL
QABEL MA ’ TIEĦU RENAGEL
Do not take Renagel if you: • have low levels of phosphate in your blood • have bowel obstruction. • are allergic (hypersensitive) to sevelamer or to any of the other ingredients of the product (see Section 6:
Tieħux Renagel • jekk għandek livelli baxxi ta ’ phosphate f’ demmek • jekk għandek imblukkar ta ’ l- imsaren • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal sevelamer jew sustanza oħra tal - prodott (Ara Sezzjoni 6:
Further information).
Aktar tagħrif)
Take special care with Renagel Children:
Oqgħod attent ħafna b’ Renagel Tfal:
The safety and efficacy in children has not been established.
Is- sigurtà u l- effikaċja fit- tfal ma ġietx stabbilita.
Therefore if you are below the age of 18 years you should consult your doctor before taking Renagel.
Għalhekk jekk int taħt it- 18- il sena int għandek tieħu parir tat- tabib tiegħek qabel ma tibda tieħu b’ Renagel.
45 Adults:
Adulti:
If any of the following applies to you, please consult your doctor before taking Renagel: • you are not on dialysis • swallowing problems • problems with motility (movement) in your stomach and bowel • retention of stomach contents • active inflammation of the bowel • have undergone major surgery on your stomach or bowel.
46 • inti m’ intix qiegħed fuq dijalisi • għandek problemi biex tibla ’ • problemi bil- motilità (moviment) fl- istonku jew l- imsaren tiegħek • trid taqla ’ mill- istonku tiegħek • infjammazzjoni attiva fl- imsaren • tkun għamilt intervent kirurġiku maġġur fl- istonku jew l- imsaren tiegħek
Additional treatments:
Trattameti addizzjonali:
Due to either your kidney condition or your dialysis treatment you may: • develop a low or high level of calcium in your blood.
Minħabba il- kondizzjoni tal- kliewi tiegħek jew il- kura ta ’ dijaliżi int għandek: • mnejn tiżviluppa livell baxx jew għoli ta ’ kalċju f’ demmek.
Since Renagel does not contain calcium your doctor might prescribe additional calcium tablets. • have a low amount of vitamin D in your blood.
Peress li Renagel ma fihx kalċju it- tabib tiegħek għandu mnejn jagħtik riċetta għall- pilloli ta ’ kalċju. • mnejn ikollok ammont baxx ta ’ Vitamina D f’ demmek.
Therefore, your doctor may monitor the levels of vitamin D in your blood and prescribe additional vitamin D as necessary.
Għalhekk it- tabib għandu mnejn jimmonitorja l- livelli ta ’ Vitamina D f’ demmek u jagħtik riċetta għal aktar Vitamina D jekk hemm bżonn.
If you do not take multivitamin supplements you may also develop low levels of vitamins A, E, K and folic acid in your blood and therefore your doctor may monitor these levels and prescribe supplemental vitamins as necessary.
Jekk ma tiħux supplimenti ta ’ multivitamini, int għandek mnejn tiżviluppa ukoll livelli baxxi ta ’ Vitamina A, E, K u folic acid f’ demmek u għalhekk it- tabib tiegħek għandu mnejn jimmonitorja dawn il- livelli u jagħtik riċetta għal vitamini supplimentali hekk kif ikun meħtieġ.
Changing treatment:
Meta taqleb it- trattament:
When you switch from another phosphate binder to Renagel, your doctor might consider monitoring the levels of bicarbonate in your blood more closely because Renagel may decrease the levels of bicarbonate.
Meta taqleb minn binder tal- fosfat ieħor għal Renagel, it- tabib tiegħek għandu mnejn jikkonsidra li jrid jissorvelja l- livelli ta ’ bikarbonat fid- demm tiegħek mill- qrib peress li Renagel jista ’ jnaqqas il - livelli ta ’ bikarbonat.
Special note for patients on peritoneal dialysis You may develop peritonitis (infection of your abdominal fluid) associated with your peritoneal dialysis.
Nota speċjali għal pazjenti b’ dijaliżi peritoneali Tista ’ tiżviluppa peritonite (infezzjoni tal fluwidu addominali tiegħek) li hi assoċjata mad- dijaliżi peritoneli tiegħek.
This risk can be reduced by careful adherence to sterile techniques during bag changes.
Dan ir- riskju jista ’ jitnaqqas bl- osservanza attenta għat- tekniċi sterili matul il- bidliet tal- borża.
You should tell your doctor immediately if you experience any new signs or symptoms of abdominal distress, abdominal swelling, abdominal pain, abdominal tenderness, or abdominal rigidity, constipation, fever, chills, nausea or vomiting.
Għandek tgħid minnufih lit- tabib tiegħek jekk ikollok xi sinjali jew sintomi ġodda ta ’ dwejjaq addomainali, nefħa addominali, uġigħ addominali, tenerezza addominali jew riġidità addominali, stitikezza, deni, tertir, dardir jew remettar.
You should expect to be monitored more carefully for problems with low levels of vitamins A, D, E, K and folic acid.
Barraminhekk, għandek tistenna li tiġi sorveljat aktar mill- qrib għal problemi b’ livelli baxxi ta ’ vitamini A, D, E, K u aċidu folliku
Taking other medicines Always mention to your doctor all medicines you are taking or have recently taken, even those obtained without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Renagel should not be taken at the same time as ciprofloxacin (an antibiotic).
Renagel m’ għandux jittieħed fl- istess żmien ma ’ ciprofloxacin (antibijotiku).
If you are taking medicines for heart rhythm problems or for epilepsy, you should consult your doctor when taking Renagel.
Jekk qed tieħu mediċini għal problemi ta ’ ritmu tal- qalb jew għall- epilessija, għandek tikkonsulta lit - tabib tiegħek meta tieħu Renagel.
The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used in transplant patients) may be reduced by Renagel.
L- effetti ta ’ mediċini bħal ciclosporin, mycophenolatemofetilu tacrolimus (mediċini użati minn pazjenti li għamlu trapjant) jista ’ jitnaqqas b’ Renagel.
Your doctor will advise you if you are taking these medicines.
It- tabib tiegħek ser jagħtik parir jekk inti qed tieħu dawn il- mediċini.
Your doctor will check for interactions between Renagel and other medicines on a regular basis.
It- tabib tiegħek ser jiċċekkja għal interazzjonijiet bejn Renagel u mediċini oħra fuq bażi regolari.
Taking Renagel with food and drink You should take Renagel tablets with meals.
Meta tieħu Renagel ma ’ l- ikel u max- xorb Int għandek tieħu l- pilloli Renagel ma ’ l- ikliet.
However, you should adhere to your prescribed diet and liquid intake.
Imma, int għandek timxi mad- dieta preskritta u ma ’ skond kemm għandek tixrob.
The tablets must be swallowed whole.
Trid tibla ’ l- pilloli sħaħ.
Pregnancy and breast-feeding If you are pregnant or breast-feeding, you should ask your doctor or pharmacist before taking Renagel.
Tqala u Treddigħ Jekk int tqila jew qed tredda ’ int għandek titlob il- parir tat- tabib jew spiżjar tiegħek qabel tieħu r - Renagel.
46 Driving and using machines Renagel is unlikely to affect your ability to drive or to operate machines.
47 Sewqan u tħaddim ta ’ magni Mhux probabbli li Renagel ser jaffettwa l- ħila tas- sewqan u tħaddim tal- magni.
HOW TO TAKE RENAGEL
KIF GĦANDEK TIEĦU RENAGEL
You should take Renagel as prescribed by your doctor.
Int għandek tieħu Renagel kif jgħidlek it- tabib tiegħek.
He/ she will base the dose on your serum phosphate level.
Hu/ hi ser jibbaża/ tibbaża d- doża skond il- livell ta ’ fosfat fis- serum.
The recommended starting dose of Renagel for adults and the elderly (> 65 years) is two to four tablets with each meal 3 times a day.
Id- doża rrakkomandata tal- bidu ta ’ Renagel għall- adulti u dawk anzjani (> 65 sena) hi ta ’ 2- 4 pilloli ma ’ kull ikla 3 darbiet kuljum.
In some cases where Renagel should be administered at the same time as another drug.
F’ xi każi meta Renagel għandu jingħata fl- istess ħin ma ’ mediċina oħra.
Your doctor may advise you to take this drug 1 hour before or 3 hours after Renagel intake, or he/ she may consider monitoring the blood levels of that drug.
It- tabib tiegħek jista ’ jagħtik parir biex tieħu din il- mediċina siegħa qabel jew 3 sigħat wara li tieħu r- Renagel, jew għandu/ għandha mnejn jara/ tara jekk għandux jimmonitorja l- livelli tad- demm ta ’ dik il- mediċina.
Your doctor will check the levels of phosphate in your blood periodically and he/ she may adjust the dose of Renagel when necessary (between 1 and 10 tablets of 400 mg per meal) to reach an adequate phosphate level.
It- tabib tiegħek ser jiċċekkja l- livelli ta ’ fosphat fid- demm tiegħek perjodikament u t- tabib għandu/ għandha mnejn jaġġusta/ taġġusta d- doża ta ’ Renagal, jekk dan ikun meħtieġ, (ta ’ bejn 1 u 10 pilloli ta ’ 400 mg ma ’ kull ikla), biex tilħaq livell adattat ta ’ phosphate.
If you take more Renagel than you should There are no reported overdoses in patients.
Jekk tieħu aktar Renagel milli suppost M’ hemm l- ebda każi ta ’ pazjenti li ħadu aktar milli suppost.
In the event of a possible overdose you should contact your doctor immediately.
F’ każ li tieħu aktar milli suppost, int għandek tikkuntattja immedjatament it- tabib tiegħek.
If you forget to take Renagel If you have missed one dose, this dose should be omitted and the next dose should be taken at the usual time with a meal.
Jekk tinsa tieħu r- Renagel Jekk tinsa tieħu doża waħda, m’ għandekx tieħu din id- doża u għandek tieħu d- doża li jmiss fil- ħin tas - soltu ma ’ l- ikel.
Do not take two doses at the same time.
Tiħux żewġ dożi fl- istess ħin.
Like all medicines, Renagel can cause side effects, although not everybody gets them.
Bħall kull mediċina oħra, Renagel jista ’ jkollu effetti oħra, għalkemm ma jidhrux fuq kulħadd
The following side effects have been reported in patients taking Renagel:
L- effetti oħra li ġejjin ġew irrapportati f’ pazjenti li qed jieħdu Renagel:
Common (likely to occur in fewer than 1 in 10 patients and more than 1 in 100 patients): diarrhoea, indigestion, abdominal pain, constipation, flatulence Very rare (likely to occur in fewer than 1 in 10,000 patients): intestinal obstruction.
Komuni ħafna (li jistgħu jseħħu f’ aktar minn pazjent 1 minn kull 10): dardir, rimettar Komuni (li jistgħu jseħħu f’ inqas minn pazjent 1 minn kull 10 u aktar minn pazjent 1 f’ 100): dijarea, indiġistjoni, uġigħ addominali, stitikezza, gass Rari ħafna (li jistgħu jseħħu f’ inqas minn pazjent 1 min kull 10, 000): sadd intestinali
Most of these events are also commonly observed in patients with chronic kidney disease and are not necessarily due to Renagel.
Ħafna minn dawn il- każi huma osservati wkoll f’ pazjenti b’ mard kroniku tal- kliewi u mhux neċessarjament huma dovuti għal Renegal.
Since constipation may be a preceding symptom in very rare cases of intestinal obstruction, please inform your doctor or pharmacist.
Peress l- istitikezzza għandha mnejn tkun sintomu ta ’ qabel f’ każijiet rari ħafna ta ’ imblukkar ta ’ l- intestini, jekk jogħġbok għarraf lit- tabib jew l- ispiżjar tiegħek.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi effetti minn dawn jisserjew, jew jekk tinduna b’ xi effetti oħrajn li mhux imniżżlin f’ dan il - fuljett, jekk jogħġbok għarraf lit- tabib jew l- ispiżjar tiegħek
HOW TO STORE RENAGEL
KIF TAĦŻEN RENAGEL
Do not store above 25 °C.
Taħżinx f’ temperatura ’ l- fuq minn 25°C.
Do not use Renagel after the expiry date stated on the labelling after the letters “ EXP”.
M’ għandekx tuża Renagel wara id- data li jiskadi dikjarata fuq it- tikketta wara l- ittri « JIS ».
47 Medicines should not be disposed of via wastewater or household waste.
48 Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Renagel contains
X’ fih Renagel
- The active substance is selevamer.
- Is- sustanza attiva hi sevelamer.
- The other ingredients are silica colloidal anhydrous and stearic acid.
- Is- sustanzi l- oħra huma silica, colloidal anhydrous u stearic acid.
The tablet coating contains
Il- qoxra tal- kapsula hi magħmula
hypromellose and diacetylated monoglycerides.
minn gelatin, titanium dioxide (E171), sodium lauryl sulphate u silicon dioxide.
The printing ink contains iron oxide black (E172), hypromellose and propylene glycol.
Il- linka ta ’ l- istampar fiha iron oxide black (E172), hypromellose and propylene glycol.
What Renagel looks like and contents of the pack
Id- dehra tal- prodott u d- daqs tal- pakkett
Renagel tablets are film coated, off white, oval tablets with Renagel 400 imprinted on one side.
Il- pilloli Renagel huma miksija b’ rita, offwajt u ovali li fuqhom hemm stampat Renagel 400 fuq naħa minnhom.
The tablets are packed in high density polyethylene bottles with a child resistant polypropylene cap and an induction seal.
Il- pilloli huma ppakkjati fi fliexken ta ’ high density polyethylene b’ għatu tal- polypropylene reżistenti għat- tfal u b’ siġġill ta ’ induzzjoni.
Pack sizes are:
Id- daqsijiet tal- pakketti huma:
Marketing authorisation holder:
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq Marketing authorisation holder:
Gooimeer 10 1411 DD Naarden The Netherlands
Gooimeer 10 1411 DD Naarden L- Olanda
Genzyme Ltd 12 Rookwood Way Haverhill, Suffolk CB9 8PB United Kingdom
Id- detenturi ta ’ l- awtorizzazzjoni tal- manifattura responsabbli mir- rilaxx tal- lott Genzyme Ltd., 12 Rookwood Way Haverhill, Suffolk CB9 8PB, Ir- Renju Unit.
IDA Industrial Park Old Kilmeaden Road Waterford Ireland
IDA Industrial Park Old Kilmeaden Road Waterford L- Irlanda
48 For any information about this medicine, please contact the local representative of the Marketing Authorisation holder.
49 Għall kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tas- Sid ta ’ l- Awtoriżżazzjoni għall- Kummerċ.
This leaflet was last approved in {MM/ YYYY}.
Dan il- fuljett kien approvat l- aħħar f ’ (XX/ SSSS).
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 Ewropea dwar il - Mediċini (EMEA) http // www. emea. europa. eu.
49 PACKAGE LEAFLET:
50 FULJETT TA ’ TAGĦRIF:
50 Adults:
Adulti:
If any of the following applies to you, please consult your doctor before taking Renagel: • you are not on dialysis • swallowing problems • problems with motility (movement) in your stomach and bowel • retention of stomach contents • active inflammation of the bowel • have undergone major surgery on your stomach or bowel.
51 • inti m’ intixqiegħed fuq dijalisi • għandek problemi biex tibla ’ • problemi bil- motilità (moviment) fl- istonku jew l- imsaren tiegħek • trid taqla ’ mill- istonku tiegħek • infjammazzjoni attiva fl- imsaren • tkun għamilt intervent kirurġiku maġġur fl- istonku jew l- imsaren tiegħek
Special note for patients on peritoneal dialysis You may develop peritonitis (infection of your abdominal fluid) associated with your peritoneal dialysis.
Nota speċjali għal pazjenti b’ dijaliżi peritoneali Tista ’ tiżviluppa peritonite (infezzjoni tal- fluwidu addominali tiegħek) li hi assoċjata mad- dijaliżi peritoneli tiegħek.
51 Driving and using machines Renagel is unlikely to affect your ability to drive or to operate machines.
52 Sewqan u tħaddim ta ’ magni Mhux probabbli li Renagel ser jaffettwa l- ħila tas- sewqan u tħaddim tal- magni.
He/ she will base the dose on your serum phosphate level.
Hu/ hi ser jibbaża/ tibbaża d- doża skond il - livell ta ’ fosfat fis- serum.
The recommended starting dose of Renagel for adults and the elderly (> 65 years) is one or two tablets with each meal 3 times a day.
Id- doża rrakkomandata tal- bidu ta ’ Renagel għall- adulti u dawk anzjani (> 65 sena) hi ta ’ pillola jew żewġ pilloli ma ’ kull ikla 3 darbiet kuljum.
Your doctor will check the levels of phosphate in your blood periodically and he/ she may adjust the dose of Renagel when necessary (between 1 and 5 tablets of 800 mg per meal) to reach an adequate phosphate level.
It- tabib tiegħek ser jiċċekkja l- livelli ta ’ fosphat fid- demm tiegħek perjodikament u t- tabib għandu/ għandha mnejn jaġġusta/ taġġusta d- doża ta ’ Renagal, jekk dan ikun meħtieġ, (ta ’ bejn 1 u 5 pilloli ta ’ 800 mg ma ’ kull ikla), biex tilħaq livell adattat ta ’ phosphate.
Very rare (likely to occur in fewer than 1 in 10,000 patients): intestinal obstruction.
Komuni ħafna (li jistgħu jseħħu f’ aktar minn pazjent 1 minn kull 10): dardir, rimettar Komuni (li jistgħu jseħħu f’ inqas minn pazjent 1 minn kull 10 u aktar minn pazjent 1 f’ 100): dijarea, indiġistjoni, uġigħ addominali, stitikezza, gass Rari ħafna (li jistgħu jseħħu f’ inqas minn pazjent 1 min kull 10, 000): sadd intestinali
52 Medicines should not be disposed of via wastewater or household waste.
53 Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
Renagel tablets are film coated, off white, oval tablets with Renagel 800 imprinted on one side.
Il- pilloli Renagel huma miksija b’ rita, offwajt u ovali li fuqhom hemm stampat Renagel 800 fuq naħa minnhom.
6 x 30 tablets 1 x 100 tablets 1x 180 tablets 2 x 180 tablets 3 x 180 tablets
6 x 30 pillola 1 x 100 pillola 1 x 180 pillola 2 x 200 pillola 3 x 180 pillola
12 Rookwood Way Haverhill, Suffolk CB9 8PB United Kingdom
Id- detenturi ta ’ l- awtorizzazzjoni tal- manifattura responsabbli mir- rilaxx tal- lott Genzyme Ltd., 12 Rookwood Way Haverhill, Suffolk CB9 8PB, Ir- Renju Unit.
53 For any information about this medicine, please contact the local representative of the Marketing Authorisation holder.
54 Għall kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tas- Sid ta ’ l- Awtoriżżazzjoni għall- Kummerċ.
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 Ewropea dwar il - Mediċini (EMEA) http // www. emea. europa. eu.
Replagal 1 mg/ ml concentrate for solution for infusion.
Replagal 1 mg/ ml konċentrat għal soluzzjoni għall- infużjoni
1 ml of concentrate for solution for infusion contains 1 mg of agalsidase alfa.
1 ml ta 'konċentrat għal soluzzjoni għall- infużjoni fih 1 mg ta' agalsidase alfa.
Each vial of 1 ml of concentrate contains 1 mg of agalsidase alfa.
Kull kunjett ta '1 ml ta' konċentrat fih 1 mg ta ’ agalsidase alfa.
Each vial of 3.5 ml of concentrate contains 3.5 mg of agalsidase alfa.
Kull kunjett ta '3. 5 ml ta' konċentrat fih 3. 5 mg ta ’ agalsidase alfa.
Agalsidase alfa is the human protein α -galactosidase A produced in a human cell line by genetic engineering technology.
Agalsidase alfa hija proteina α- galactosidase A umana li hija prodotta minn razza ta 'ċelloli umani bit- teknoloġija ta' l- inġinerija ġenetika.
A clear and colourless solution.
Soluzzjoni ċara u bla kulur.
Replagal is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry Disease (α -galactosidase A deficiency).
Replagal huwa intiż għal terapija ta 'sostituzzjoni ta' enżimi fuq żmien twil f' pazjenti li huma konfermati bil- Marda ta 'Fabry (defiċjenza ta' α- galactosidase A).
Replagal treatment should be supervised by a physician experienced in the management of patients with Fabry Disease or other inherited metabolic diseases.
It- trattament b' Replagal għandu jiġi sorveljat minn tabib li għandu esperjenza fil- ġestjoni ta 'pazjenti bil- Marda ta' Fabry jew mard ereditarju marbut mal- metaboliżmu.
Replagal is administered at a dose of 0.2 mg/ kg body weight every other week by intravenous infusion over 40 minutes.
Replagal għandu jingħata f' doża ta '0. 2 mg/ kg piż korporali ġimgħa iva u ġimgħa le permezz ta' infużjoni ġol- vina fuq perijodu ta '40 minuta.
For preparation and administration instructions, see section 6.6.
Għal aktar informazzjoni dwar il- preparazzjoni u kif jingħata, ara sezzjoni 6. 6.
Patients aged over 65 years Studies in patients over the age of 65 have not been performed and no dosage regimen can presently be recommended in these patients as safety and efficacy have not yet been established.
Pazjenti li għandhom aktar minn 65 sena Ma sarux studji f' pazjenti li għandhom aktar minn 65 sena u l- ebda reġimen ta 'doża ma jista' jiġi rakkomandat attwalment f' dawn il- pazjenti peress li s- sigurtà u l- effikaċja għalihom għadhom ma ġewx stabbiliti.
Patients with hepatic impairment No studies have been performed in patients with hepatic impairment.
Pazjenti b' indeboliment tal- fwied Ma sarux studji f' pazjenti li għandhom indeboliment tal- fwied.
Patients with renal impairment No dose adjustment is necessary in patients with renal impairment.
Pazjenti b' indeboliment tal- kliewi L- ebda aġġustament fid- doża mhu meħtieġ f' pazjenti li għandhom indeboliment tal- kliewi.
The presence of extensive renal damage (eGFR < 60mL/ min) may limit the renal response to enzyme replacement therapy.
Il- preżenza ta 'ħsara estensiva fil- kliewi (eGFR < 60mL/ min) tista' tirristrinġi r- rispons tal- kliewi għal terapija ta 'sostituzzjoni ta' enżimi.
Limited data are available in patients on dialysis or post-kidney transplantation, no dose adjustment is recommended.
L- ebda aġġustament fid- doża mhu meħtieġ minn dejta ristretta disponibbli għal pazjenti li qegħdin fuq dijalisi jew wara t- trapjant tal- kliewi.
Paediatric Patients The experience in children is limited.
Pazjenti pedjatriċi L- esperjenza fi tfal hi ristretta.
Studies in children (0-6 years) have not been performed and no dosage regimen can presently be recommended in the patients as safety and efficacy have not yet been established.
Ma sarux studji fi tfal (0- 6 snin) u l- ebda reġmen ta 'dożi ma jista' attwalment jiġi rakkomandat għal pazjenti peress li s- sigurtà u l- effikaċja għalihom għadhom ma ġewx stabbiliti.
Limited clinical data in children (7-18 years) do not permit to recommend an optimal dosage regimen presently (see section 5.2).
Attwalment, dejta klinika ristretta fi tfal (7- 18- il sena) ma tippermettiex li jiġi rakkomandat
2 the 6 month study with Replagal administered at 0.2 mg/ kg in this population, this dose regimen is suggested for children between 7– 18 years of age.
Peress li ma kienx hemm kwistjonijiet ta 'sigurtà inkontrati fl- istudju li dam sejjer sitt xhur b' Replagal mogħti f' doża ta' 0. 2 mg/ kg f' din il- popolazzjoni, dan ir- reġimen tad- doża hu rakkomandat għal tfal bejn 7 - 18- il sena ta 'età.
Hypersensitivity to the active substance or any of the excipients.
Sensittività eċċessiva gћas- sustanza attiva jew gћal xi sustanzi mhux attivi.
Idiosyncratic infusion related reactions 13.7% of patients treated with Replagal in clinical trials have experienced idiosyncratic infusion related reactions.
Reazzjonijiet idjosinkratiċi relatati ma ’ l- infużjoni Fi provi kliniċi 13. 7% ta ’ pazjenti trattati b’ Replagal kellhom reazzjonijiet idjosinkratiċi relatati ma ’ l- infużjoni.
Overall, the percentage of infusion related reactions was significantly lower in females than males.
Kollox ma ’ kollox il- persentaġġ ta ’ reazzjonijiet relatati ma ’ l- infużjoni kienu sinifikattivament aktar baxxi fin- nisa milli fl- irġiel.
The most common symptoms have been rigors, headache, nausea, pyrexia, flushing and fatigue.
L- aktar sintomi komuni kienu tertir, uġigħ ta 'ras, dardir, deni, ħmura u għejja.
Serious infusion reactions have been reported uncommonly; symptoms reported include pyrexia, rigors, tachycardia, urticaria, nausea/ vomiting, angioneurotic oedema with throat tightness, stridor and swollen tongue.
Reazzjonijiet serji ta 'l- infużjoni ġew rapportati mhux komunement; sintomi rapportati jinkludu deni, tertir, takikardja, urtikarja, dardir/ remettar, edema anġjonewrotika b’ issikkar fil- griżmejn, stridor u nefħa fl- ilsien.
Other infusion-related symptoms may include dizziness and hyperhidrosis.
Sintomi oħrajn relatati ma ’ infużjoni jistgħu jinkludu sturdament u iperidrożi.
The onset of infusion related reactions has generally occurred within the first 2-4 months after initiation of treatment with Replagal although later onset (after 1 year) has been reported as well.
Il- bidu ta ’ reazzjonijiet relatati ma ’ infużjonijiet ġeneralment seħħew fl - ewwel 2- 4 xhur minn wara l- bidu ta ’ trattament b’ Replagal għalkemm bidu aktar tard (wara sena) kien irrapportat ukoll.
These effects have decreased with time.
Dawn l- effetti naqsu maż- żmien.
If mild or moderate acute infusion reactions occur, medical attention must be sought immediately and appropriate actions instituted.
Jekk iseħħu reazzjonijiet akuti minn ħfif sa moderati għall- infużjoni, wieħed minnufih għandu jfittex għal attenzjoni medika u għandhom jinbdew proċeduri xierqa.
The infusion can be temporarily interrupted (5 to 10 minutes) until symptoms subside and the infusion may then be restarted.
L- infuzjoni tista ’ tiġi temporanjament imwaqqfa (għal brjn 5 sa 10 minuti) sakemm is- sintomi jbattu u l- infuzjoni tista ’ imbagħad terġa tinbeda mill- ġdid.
Mild and transient effects may not require medical treatment or discontinuation of the infusion.
Effetti ħfief jew transitorji jistgħu ma jeħteġux trattament mediku jew tittwaqqif ta ’ l- infużjoni.
In addition, oral or intravenous pre-treatment with antihistamines and/ or corticosteroids, from 1 to 24 hours prior to infusion may prevent subsequent reactions in those cases where symptomatic treatment was required.
Barraminhekk, trattament orali jew intravenuż minn qabel b’ antiħistamini u/ jew kortikosterojdi, minn 1 sa 24 siegħa qabel l- infużjoni jista ’ jimpedixxi reazzjonijiet sussegwenti f’ dawk il- każijiet fejn trattament sintomatiku ikun meħtieġ.
Allergic-type hypersensitivity reactions As with any intravenous protein product, allergic-type hypersensitivity reactions are possible.
Reazzjonijiet ta 'sensittività eċċessiva ta' tip allerġiku Bħal fil- każ ta 'kull prodott ieħor li fih il- proteini li jingħata ġol- vini, jista' jkun hemm reazzjonijiet ta 'sensittività eċċessiva ta' tip allerġiku.
If severe allergic or anaphylactic-type reactions occur, the administration of Replagal should be discontinued immediately and appropriate treatment initiated.
Jekk iseħħu reazzjonijiet allerġiċi jew ta ’ tip anafilaktojde severa, l- għoti jista jiġi mwaqqaf fil- pront u proċeduri xierqa ta 'trattament għandhom jinbdew.
The current medical standards for emergency treatment are to be observed.
Għandhom jiġu osservati l- istandards attwali għal trattament mediku.
IgG antibodies to the protein As with all protein pharmaceutical products, patients may develop IgG antibodies to the protein.
Antikorpi IgG għall- proteina Bħal bil- prodotti farmaċewtiċi kollha li fihom il- proteina, il- pazjenti jistgħu jiżviluppaw antikorpi IgG għall- proteina.
A low titre IgG antibody response has been observed in approximately 24% of the male patients treated with Replagal.
Reazzjoni ta ’ l- antikorpi IgG f’ titru baxx ġiet osservata f’ bejn wieħed u ieħor 24% tal- pazjenti rġiel ittrattati b’ Replagal.
Based on limited data this percentage has been found to be lower (7%) in the male paediatric population.
Ibbażat fuq dejta ristretta dan il- persentaġġ instab li kien aktar baxx (7%) fil- popolazzjoni pedjatrika maskili.
These IgG antibodies appeared to develop following approximately 3-12 months of treatment.
Dawn l- antikorpi IgG dehru li żviluppaw bejn wieħed u ieħor bejn 3- 12- il xahar wara t- trattament.
After 12 to 54 months of therapy, 17% of Replagal treated patients were still antibody positive whereas 7% showed evidence for the development of immunologic tolerance, based on the disappearance of IgG antibodies over time.
Wara 12 sa 54 xahar ta ’ terapija, 17% ta ’ pazjenti ttrattati b’ Repagal kienu għadhom pożittivi għal antikorpi filwaqt li ma wrew l- ebda evidenza ta ’ żvilupp ta ’ tolleranza immunoloġika, ibbażat fuq l- għejbin ta ’ antikorpi IgG matul iż- żmien.
The remaining 76% remained antibody negative throughout.
Is- 76% l- oħra baqgħu negattivi għal antikorpi l- ħin kollu.
No IgE antibodies have been detected in any patient receiving Replagal.
Antikorpi IgE ma ġew osservati fl- ebda pazjent li qiegħed jingħata Replagal.
Patients with renal impairment The presence of extensive renal damage may limit the renal response to enzyme replacement therapy, possibly due to underlying irreversible pathological changes.
Pazjenti b' indeboliment tal- kliewi Il- preżenza ta ’ ħsara renali estensiva tista ’ tirristrinġi r- reazzjoni għal terapija ta ’ sostituzzjoni ta ’ l- enżimi, possibbilment minħabba bidliet patoloġiċi rriversibbli li diġà jkunu hemm.
In such cases, the loss of renal function remains within the expected range of the natural progression of disease.
F’ każijiet bħal dawn, it- telf tal- funzjoni renali jibqa ’ fi ħdan il- firxa mistennija tal- progressjoni naturali tal- marda.
Replagal should not be co-administered with chloroquine, amiodarone, benoquin or gentamicin since these substances have the potential to inhibit intra-cellular α -galactosidase activity.
Replagal m’ għandux jingħata flimkien ma ’ chloroquine, amiodarone, benoquin jew gentamicin peress li dawn il- mediċini għandhom potenzjal li jinibixxu l- attività ta ’ α- galactosidase intra- ċellolari.
As α -galactosidase A is itself an enzyme, it would be an unlikely candidate for cytochrome P450 mediated drug-drug interactions.
Peress li α- galactosidase A hija hi stess enżima, hi tkun kandidata improbabbli għal effetti interattivi bejn mediċina u pħra li jsiru permezz ta ’ cytochrome P450.
In clinical studies, neuropathic pain medicinal products (such as carbamazepine, phenytoin and gabapentin) were administered concurrently to most patients without any evidence of interaction.
Fi studji kliniċi, prodotti mediċinali għal
3 4.6 Pregnancy and lactation
3 uġigħ newropatiku (bħal ma huma carbamazepine, phenytoin u gabapentin) kienu mogħtija fl- istess waqt ’ il parti l- kbira tal- pazjenti mingħajr l- ebda evidenza ta ’ interazzjoni.
Very limited clinical data on pregnancies exposed to Replagal (n=4) have shown no adverse effects on the mother and newborn child.
Tagħrif minn għadd ristrett (n=4) dwar l- użu tiegħu waqt it- tqala juri li m' hemm l- ebda effetti mhux mixtieqa fuq is- saħħa ta 'l- omm u t- tarbija tat- twelid.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy or embryonal/ foetal development when exposed during organogenesis (see Section 5.3).
Studji fuq il- bhejjem ma jurux effetti ħżiena diretti jew indiretti fuq it- tqala, fuq l- iżvilupp ta 'l- embriju/ fetu, meta espost waqt l- organoġenisi (ara 5. 3).
It is not known whether Replagal is excreted in human milk.
Mhux magħruf jekk Replagal hux eliminat fil- ħalib tal- bniedem.
Caution should be exercised when prescribing to pregnant or breast-feeding women.
Wieħed għandu joqgħod attent meta jikteb riċetta għal din il- mediċina għal nisa tqal.
Replagal has no or negligible influence on the ability to drive and use machines.
Replagal m' għandu l- ebda jew effett negliġibbli biss fuq il- ħila ta 'sewqan u l- użu ta' magni.
The most commonly reported undesirable effects were infusion associated reactions, which occurred in 13.7% of patients treated with Replagal in clinical trials.
L- aktar effetti mhux mixtieqa komuni rapportati kienu reazzjonijiet assoċjati ma ’ l- infużjoni, li fi provi kliniċi seħħew fi 13. 7% ta ’ pazjenti ttrattati b’ Replagal.
Most undesirable effects were mild to moderate in severity.
Fil- parti l- kbira l- effetti mhux mixtieqa kienu ta 'severità ħafifa għal moderata.
Table 1 lists adverse drug reactions (ADRs) reported for the 153 patients treated with Replagal in clinical trials, including 21 patients with history of endstage renal disease and 17 female patients.
Tabella 1 telenka r- reazzjonijiet avversi tal- mediċina (ADRs) rapportati fuq 153 pazjent ittrattati b’ Replagal fi provi kliniċi, li jinkludu 21 pazjent bi storja ta ’ mard renali fl- istadju finali u 17- il pazjent mara.
Information is presented by system organ class and frequency (very common > 1/ 10; common > 1/ 100 ,< 1/10; uncommon > 1/1000 ,< 1/100).
L- informazzjoni qed tiġi preżentata skond il- kategorija tas- sistema ta 'l- organi u l- frekwenza (komuni ħafna > 1/ 10; komuni > 1/ 100, < 1/ 10; mhux komuni > 1/ 1000, < 1/ 100).
The occurrence of an event in a single patient is defined as uncommon in view of the number of patients treated.
Meta jseħħ każ fuq pazjent wieħed dan huwa mfisser bħala mhux komuni in vista tal- fatt ta 'l- għadd ta' persuni trattati.
A single patient could be affected by several ADRs.
Pazjent wieħed jista 'jiġi affettwat b' diversi ADRs.
Table 1 Metabolism and nutrition disorders
Disturbi fil- metaboliżmu u n- nutrizzjoni
peripheral oedema
edma periferika
headache dizziness, dysgeusia, neuropathic pain, tremor, hypersomnia, hypoesthesia, paraesthesia
uġigħ ta 'ras stordament, disgewsja, uġigħ newropatiku, tertir, ipersomnija, ipoestesja, paraestesja
parosmia
parosmija
lacrimation increased
jiżdid id- dmugħ
tinnitus, tinnitus aggravated
tinnite, tinnite aggravata
tachycardia, palpitations
takikardja, palpitazzjonijiet
flushing hypertension
fwawar pressjoni għolja
cough, hoarseness, throat tightness, dyspnoea, nasopharyngitis, pharyngitis, throat secretion increased, rhinorrhoea
sogħla, ħanqa, issikar fil- griżmejn, dispnea, nasofarinġite, faringite, żieda fil- katarru mill- griżmejn, rinorrea
nausea diarrhoea, vomiting, abdominal pain/ discomfort
dijarrea, remettar, uġigħ/ dwejjaq addominali
Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit - tessuti ta 'taħt il- ġilda
acne, erythema, pruritus, rash, livedo reticularis angioneurotic oedema, urticaria
akne, eritema, ħakk, raxx, livedo reticularis edema anġjonewrotika, urtikarja