qanastek/EMEA-V3 huggingface dataset:
The expiry date refers to the last day of that month. • Store in a refrigerator (2°C – 8°C).
Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar. • Aħżen fi- friġġ (2°C – 8°C).
The reconstituted diluted infusion solution is stable for 24 hours at 25°C, but for bacteriological reasons it is recommended to use it as soon as possible.
Is- soluzzjoni rikostitwita u dilwita għall- infużjoni hija stabbli għal 24 siegħa f’ temperatura ta ’ 25°C, iżda għal raġunijiet batterjoloġiċi, huwa rakkomandat li tintuża kemm jista ’ jkun malajr.
The infusion is to be started within 3 hours of reconstitution and dilution.
L - infużjoni għandha tinbeda fi żmien 3 sigħat minn meta tkun rikostitwita u dilwita.
When reconstitution and dilution are performed under aseptic conditions, Remicade infusion solution can be used within 24 hours if stored at 2°C to 8°C.
Meta tkun rikostitwita u dilwita taħt kundizzjonijiet asettiċi, is- soluzzjoni ta ’ Remicade għall- infużjoni tista ’ tintuża fi żmien 24 siegħa jekk tinħażen f’ temperatura ta ’ bejn 2°C - 8°C.
Remicade will not be given to you if there are opaque particles, discolouration or other foreign particles present.
It- tabib tiegħek jew xi professjonist ieħor fil- qasam tal- kura tas- saħħa ser jieħdu ħsieb l- imaniġġjar u l - ħażna ta ’ Remicade Remicade mhux se jingħatalek jekk ikun hemm xi frak mhux ċar, telf tal- kulur jew frak ieħor preżenti.
FURTHER INFORMATION
X’ fih Remicade
What Remicade contains • The active substance is infliximab.
- Is- sustanza attiva hi infliximab.
After reconstitution each ml contains 10 mg of infliximab. • The other ingredients are sucrose, polysorbate 80, monobasic sodium phosphate and dibasic sodium phosphate.
kull ml jkun fih 10 mg ta ’ infliximab.
What Remicade looks like and contents of the pack Remicade is supplied as a glass vial containing a powder.
Id- Dehra ta ’ Remicade u l- kontenuti tal- pakkett Remicade jiġi bħala kunjett tal- ħġieġ li jkun fih trab.
The powder is a freeze-dried white pellet.
It- trab huwa pellit bajda mnixxfa bil- friża.
Remicade is produced in packs of 1, 2, 3, 4 or 5 vials, but not all pack sizes may be marketed.
Remicade jiġi f’ pakketti ta ’ 1, 2, 3, 4 jew 5 kunjetti, iżda jista ’ jkun li mhux id- daqsijiet kollha jkunu għal skop kummerjali.
45 Einsteinweg 101 2333 CB Leiden The Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
2 BG-София 1407 Tел.: +359 2 806 3030
3 BG София 11407 Tел.: +359 2 806 3030
Nederland Walmolen 1NL-3994 DL Houten Tel: + 31-(0)800 999 90 00
Nederland Walmolen 1 NL- 3394 DL Houten Tel: + 31 - (0) 800 999 90 00
Taśmowa 7 PL-02-677 Warszawa Tel.: + 48-(0)22 478 41 50
Taśmowa 7 PL- 02- 677 Warszawa Tel.: + 48 - (0) 22 478 41 50Al.
France 34 avenue Léonard de Vinci F-92400 Courbevoie Tél: + 33-(0)1 80 46 40 40
France 34 avenue Léonard de Vinci92 rue Baudin F- 92300 92400 Courbevoie Tél: + 33 - (0) 1 80 46 40 40
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
47 THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY:
48 IT- TAGĦRIF LI JMISS QED JINGĦATA BISS GĦALL- PROFESSJONISTI FIL- QASAM MEDIKU JEW FIL- KURA TAS- SAĦĦA:
Instructions for use and handling – reconstitution, dilution and administration
Tagħrif għal użu u mmaniġġjar- biex ikun rikostitwit, dilwit u mogħti
Dilute the total volume of the reconstituted Remicade solution dose to 250 ml with sodium chloride 9 mg/ml (0.9%) solution for infusion.
Iddilwixxi l- volum totali tad- doża tas- soluzzjoni rikostitwita Remicade għal 250 ml b’ soluzzjoni għall- infużjoni ta ’ sodium chloride 9 mg/ ml (0. 9%).
This can be accomplished by withdrawing a volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion from the 250-ml glass bottle or infusion bag equal to the volume of reconstituted Remicade.
Dan jista ’ jsir billi jinġibed volum tas - soluzzjoni għall- infużjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) mil- flixkun tal- ħġieġ jew borża ta ’ l- infużjoni ta ’ 250 ml li jkun daqs il- volum ta ’ Remicade rikostitwit.
Do not store any un used portion of the infusion solution for reuse.
Taħżinx xi parti mis- soluzzjoni biex tużaha darb’ oħra.
What is Renagel?
X' inhu Renagel?
Renagel is a medicine containing the active substance sevelamer.
Renagel hu mediċina li fiha s- sustanza attiva sevelamer.
It is available as white oval tablets (400 mg and 800 mg).
Huwa disponibbli bħala pilloli ovali bojod (400 mg u 800 mg).
What is Renagel used for?
Għal xiex jintuża Renagel?
Renagel is used to control hyperphosphataemia (high blood phosphate levels) in adult patients on dialysis (a blood clearance technique).
Renagel jintuża għall- kontroll ta 'l- iperfosfatemija (livelli għoljin ta' fosfat fid- demm) f' pazjenti adulti li għaddejjin minn dijaliżi (teknika tat- tisfija tad- demm).
It can be used in patients undergoing haemodialysis (using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood).
Jista 'jintuża f' pazjenti li għaddejjin mill - emodijaliżi (bl- użu ta' magna li tiffiltra d- demm) jew dijaliżi peritoneali (il- fluwidu jiġi ppumpjat fiż - żaqq u membrana interna tiffiltra d- demm).
Renagel should be used with other treatments such as calcium supplements and vitamin D3 to control the development of bone disease.
Renagel għandu jintuża ma 'trattamenti oħra bħal supplimenti tal- kalċju u tal- vitamina D3 biex jikkontrolla l- iżvilupp ta' mard ta 'l- għadam.
How is Renagel used?
Kif jintuża Renagel?
The recommended starting dose of Renagel depends on the level of phosphate in the blood and ranges from 800 to 1,600 mg three times a day.
Id- doża inizjali rakkomandata ta 'Renagel tiddependi mil- livell ta' fosfat fid- demm u tvarja bejn 800 u 1, 600 mg tliet darbiet kuljum.
The dose of Renagel should be adjusted to ensure that the blood phosphate level stays below 1.76 mmol/ l.
Id- dożaġġ ta 'Renagel għandu jkun aġġustat biex jassigura li l- livelli ta' fosfat fid- demm jibqgħu anqas minn 1. 76 mmol/ l.
Patients should take Renagel tablets whole with meals and stick to their prescribed diets.
Il- pazjenti għandhom jieħdu l- pilloli ta 'Renagel sħaħ ma' l- ikel u jżommu mad- dieti preskritti.
The safety and effectiveness of Renagel have not been established in children.
Is- sigurtà u l- effikaċja ta 'Renagel fit- tfal ma ġewx stabbiliti.
How does Renagel work?
Kif jaħdem Renagel?
Patients with severe kidney disease cannot eliminate phosphate from their bodies.
Il- pazjenti bi problemi gravi fil- kliewi ma jistgħux jeliminaw il- fosfat minn ġisimhom.
This leads to hyperphosphataemia, which, in the long term, can cause complications such as heart disease.
Dan iwassal għal iperfosfatemija, li hija kundizzjoni li, fit- tul, tista 'tikkawża kumplikazzjonijiet bħal mard tal- qalb.
The active substance in Renagel, sevelamer, is a phosphate binder.
Is- sustanza attiva f' Renagel, sevelamer, hija sustanza li teħel mal- fosfat.
When taken with meals, sevelamer binds to phosphate from food within the gut, preventing it from being absorbed into the body.
Meta jittieħed ma 'l- ikel, sevelamer jeħel mal- fosfat preżenti fl- ikel ta' ġo l- imsaren, u b' hekk iwaqqaf l- assorbiment tiegħu fil - ġisem.
This help to reduce the phosphate levels in the blood.
Dan jgħin biex inaqqas il- livelli ta 'fosfat fid- demm.
How has Renagel been studied?
Kif ġie studjat Renagel?
The effects of Renagel were first tested in experimental models before being studied in humans.
L- effetti ta 'Renagel għall- ewwel ġew ittestjati f' mudelli sperimentali qabel ma ġew studjati fil - bniedem.
In haemodialysis, Renagel has been studied in two short-term studies lasting eight weeks and one longer study lasting 44 weeks.
Fl- emodijaliżi, Renagel ġie studjat f' żewġ studji b' terminu ta 'żmien qasir li damu 8 ġimgħat u wieħed itwal li dam 44 ġimgħa.
The first study compared Renagel with calcium acetate (another phosphate-lowering medicine) in 84 patients.
L- ewwel studju qabbel Renagel mal- kalċju aċetat (calcium acetate, mediċina oħra li tbaxxi l- livell tal- fosfat) f' 84 pazjent.
The second, which did not compare Renagel with any
Fit- tieni studju, li ma qabbilx Renagel ma 'mediċina oħra,
Reproduction is authorised provided the source is acknowledged. other medicine, included 172 patients.
Reproduction is authorised provided the source is acknowledged. ħadu sehem 172 pazjent.
The longer study examined the use of Renagel in 192 patients, the majority of whom had taken Renagel in previous studies.
L- istudju t- twil eżamina l- użu ta 'Renagel f' 192 pazjent li l- maġġoranza tagħhom kienu ħadu Renagel fi studji preċedenti.
In peritoneal dialysis, there has been one study of Renagel comparing its effectiveness with that of calcium acetate in 143 patients over 12 weeks.
Fid- dijaliżi peritoneali, kien hemm biss studju wieħed ta 'Renagel li qabbel l- effikaċja tiegħu ma' dik tal- kalċju aċetat f' 143 pazjent fuq perjodu ta '12- il ġimgħa.
In all studies, the main measure of effectiveness was the change in blood phosphate levels between the start and the end of treatment.
Fl- istudji kollha, il- mezz ewlieni tal- kejl ta 'l- effikaċja kien it- tibdil fil- livelli ta' fosfat fid- demm bejn il- bidu u t- tmiem tat- trattament.
What benefit has Renagel shown during the studies?
X' inhuma l- benefiċċji ta 'Renagel li ħarġu minn dawn l- istudji?
Renagel produced a significant decrease in serum phosphate in all studies.
Renagel wassal għal tnaqqis sinifikanti tal- livelli tas- serum ta 'fosfat fl- istudji kollha.
In the comparative study of patients undergoing haemodialysis, there was an average fall of 0.65 mmol/ l over the eight weeks of Renagel treatment, compared with 0.68 mmol/ l when the patients were taking calcium acetate.
Fl- istudju kumparattiv ta 'pazjenti li għaddejjin minn emodijaliżi, ġie irreġistrat tnaqqis medju ta' 0. 65 mmol/ l fuq il- perjodu ta 'tmien ġimgħat tat- trattament b' Renagel, meta mqabbla ma' 0. 68 mmol/ l meta l- pazjenti kienu qed jieħdu l- kalċju aċetat.
Patients taking Renagel had a similar fall in phosphate levels in the second study.
Il- pazjenti li kienu qed jieħdu Renagel kellhom tnaqqis simili tal- livelli ta 'fosfat fit- tieni studju.
In the third, there was an average fall of 0.71 mmol/ l over 44 weeks.
Fit- tielet studju kien hemm tnaqqis medju ta '0. 71 mmol/ l fuq perjodu ta' 44 ġimgħa.
In the study of patients undergoing peritoneal dialysis, the patients receiving Renagel had similar falls in phosphate to those receiving calcium acetate (0.52 and 0.58 mmol/ l, respectively).
Fl- istudju ta 'pazjenti li kienu sottoposti għal dijaliżi peritoneali, il- pazjenti li kienu qed jirċievu Renagel kellhom tnaqqis fil- livelli tal- fosfat simili għal dawk li kienu qed jirċievu l- kalċju aċetat (0. 52 u 0. 58 mmol/ l, rispettivament).
What is the risk associated with Renagel?
X' inhuma r- riskji assoċjati ma 'Renagel?
The most common side effects with Renagel (seen in more than 1 patient in 10) are nausea (feeling sick) and vomiting.
L- effetti sekondarji l- aktar komuni b' Renagel (li dehru f' aktar minn pazjent 1 minn 10) huma nawżea (dardir) u remettar.
For the full list of all side effects reported with Renagel, see the Package Leaflet.
Għal- lista sħiħa ta 'effetti sekondarji rrappurtati ma' Renagel, ara l- Fuljett ta 'Tagħrif.
Renagel should not be used in people who may be hypersensitive (allergic) to sevelamer or any of the other ingredients.
Renagel ma għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal sevelamer jew għal xi ingredjenti oħra tiegħu.
Renagel should also not be used in people with hypophosphataemia (low blood phosphate levels) or with bowel obstruction (a blockage in the gut).
Renagel lanqas ma għandu jintuża minn persuni b' ipofosfatemija (livell baxx ta 'fosfat fid- demm) jew b' ostruzzjoni (sadd) fil- musrana.
Why has Renagel been approved?
Għaliex ġie approvat Renagel?
The Committee for Medicinal Products for Human Use (CHMP) decided that Renagel’ s benefits are greater than its risks for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Renagel huma ogħla mir- riskji tiegħu meta jintuża fil- kontroll ta' l- iperfosfatemija fil- pazjenti adulti sottoposti għal emodijaliżi jew dijaliżi peritoneali.
The Committee recommended that Renagel be given marketing authorisation.
Il- Kumitat irrakkomanda li Renagel jingħata awtrorizzazzjoni għat- tqegħid fis- suq.
Renagel was originally authorised under ‘ Exceptional Circumstances’, because, for scientific reasons, limited information was available at the time of approval.
Oriġinarjament, Renagel kien ġie awtorizzat f '"Ċirkostanzi Eċċezzjonali", minħabba li meta ngħatat l - awtorizzazzjoni, kien disponibbli tagħrif limitat, għal raġunijiet xjentifiċi.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 26 June 2006.
Billi l- kumpanija pprovdiet it- tagħrif addizzjonali mitlub, iċ - "Ċirkostanzi Eċċezzjonali" ntemmu fis- 26 ta 'Ġunju 2006.
Other information about Renagel:
Aktar tagħrif dwar Renagel:
The European Commission granted a marketing authorisation valid throughout the European Union for Renagel to Genzyme Europe B. V. on 28 January 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Renagel lil Genzyme Europe B. V. fit- 28 ta 'Jannar 2000.
The marketing authorisation was renewed on 28 January 2005.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 28 ta 'Jannar 2005.
The full EPAR for Renagel can be found here.
L- EPAR sħiħ għal Renagel jista 'jiġi konsultat hawn.
Renagel 400 mg film-coated tablets
Renagel 400 mg pilloli miksijin b’ rita
Each tablet contains 400 mg sevelamer.
Kull pillola fiha 400 mg sevelamer.
Film-coated tablet The off-white, oval tablets are imprinted with Renagel 400 on one side.
Pilloli miksijin b’ rita Il- pilloli offwajt, ovali għandhom Renagel 400 stampat fuq naħa waħda.
Renagel is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Renagel hu indikat għall- kontroll ta ’ l- iperfosfatemija f’ pazjenti adulti li qed jirċievu dijaliżi tad - demm jew dijaliżi peritoneali.
Renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 – dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
Renagel għandu jintuża fi ħdan kuntest ta ’ metodu terapewtiku multiplu, li jista ’ jinkludi supplimenti tal- kalċju, 1, 25 – dihydroxy Vitamin D3 jew wieħed mill - analogi tiegħu biex jikkontrollaw l- iżvilupp tal- mard ta ’ l- għadam renali.
Children The safety and efficacy of this product has not been established in patients below the age of 18 years.
It- tfal Is- sigurtà u l- effikaċja ta ’ dan il- prodott għadhom ma ġewx stabbiliti f’ pazjenti taħt it- 18- il sena.
Adults and elderly (> 65 years) For patients who are not on phosphate binders, dosage is determined individually based on serum phosphate concentration as indicated in the table below:
Adulti u anzjani (> 65 sena) Għal pazjenti li mhumiex qed jieħdu sustanzi li jorbtu phosphate, id- doża tkun determinata individwalment u tkun ibbażata fuq konċentrazzjoni ta ’ phosphate fis- serum hekk kif inhi indikata fit - tabella t’ hawn taħt:
Serum phosphate level in patients not on phosphate binders
Livell ta ’ fosfat fis- serum
of Renagel 400 mg tablets
Doża inizjali tal- pilloli Renagel 400 mg
1.76 – 2.42 mmol/ l (5.5-7.5 mg/ dl) 2.42 – 2.91 mmol/ l (7.5-9 mg/ dl) > 2.91 mmol/ l (> 9 mg/ dl)
fil- pazjenti li m’ humiex qed jieħdu s- sustanzi li jorbtu l- fosfat 1. 76 – 2. 42 mmol/ l (5. 5- 7. 5 mg/ dl) 2. 42 – 2. 91 mmol/ l (7. 5- 9 mg/ dl) > 2. 91 mmol/ l (> 9 mg/ dl)
2 tablets, 3 times per day 3 tablets,3 times per day 4 tablets, 3 times per day
2 pilloli, 3 darbiet kuljum 3 pilloli, 3 darbiet kuljum 4 pilloli, 3 darbiet kuljum
If Renagel is prescribed as an alternative phosphate binder, Renagel should be given in equivalent doses on a mg weight basis compared to the patient’ s previous calcium based phosphate binder.
Jekk Renagel jingħata bir- riċetta tat- tabib bħala sustanza alternattiva li torbot phosphate, Renagel għandu jingħata f’ dożi ekwivalenti fuq bażi ta ’ piż f’ mg imqabbel mas- sustanza li torbot il- phosphate ibbażata fuq il- kalċju li ngħata qabel lill- pazjent.
Serum phosphate levels should be closely monitored and the dose of Renagel adjusted accordingly with the goal of lowering serum phosphate to 1.76 mmol/ l (5.5mg/ dl) or less.
Il- livelli ta ’ phosphate fis- serum għandhom ikunu monitorjati sewwa u d- doża ta ’ Renagel għandha tkun aġġustata skond l- objettiv tat - tnaqqis tal- phosphate fis- serum għal 1. 76 mmol/ 1 (5. 5mg/ dl) jew inqas.
Serum phosphate should be tested every two to three weeks until a stable serum phosphate level is reached and on a regular basis thereafter.
Phosphate fis- serum għandu jkun ittestjat bejn kull ġimgħatejn sa tlett ġimgħat sakemm jintlaħaq livell stabbli ta ’ phosphate fis - serum u fuq bażi regolari wara.
The dose range may vary between 1 and 10 capsules per meal.
Il- firxa tad- doża tista ’ tvarja bejn 1 u 10 400 mg pillola ma ’ kull ikla.
The average actual daily dose used in the chronic phase of a one year clinical study was 7 grams of sevelamer.
Id- doża ta ’ kuljum attwali medja li ntużat fil- fażi kronika ta ’ studju kliniku ta ’ sena kien ta ’ 7 grammi sevelamer.
2 4.3 Contra-indications
2 Il- pazjenti għandhom jieħdu Renagel ma ’ l- ikel u josservaw id- dieta preskritta tagħhom.
4.4 Special warnings and precautions for use
Tomgħodhomx.
Efficacy and safety of Renagel has not been studied in children or in predialysis patients.
4. 3 Kontra- indikazzjonijiet
The safety and efficacy of Renagel has not been studied in patients with swallowing disorders, untreated or severe gastroparesis, and retention of gastric contents.
L- effikaċja u sigurtà ta ’ Renagel ma ġewx studjati f’ pazjenti li għandhom problemi biex jibilgħu, gastroparesi li ma ġietx ikkurata jew severa, u żamma tal - kontenut gastriku.
Renagel should only be used in these patients following careful assessment of benefit and risks.
Renagel għandu jintuża biss fil- każ ta ’ dawn il- pazjenti wara assessjar bir- reqqa tal- benefiċċji u riskji.
Efficacy and safety of Renagel has not been studied in patients with active inflammatory bowel disease, gastrointestinal motility disorders, abnormal or irregular bowel motion and patients with a history of major gastrointestinal surgery.
L- effikaċja u sigurtà ta ’ Renagel ma ġewx studjati f’ pazjenti li għandhom mard ta ’ l- imsaren imfjammati f’ fażi attiva, diżordnijiet tal- motilità gastrointestinali, ippurgar annormali jew irregolari, u pazjenti li għamlu operazzjonijiet kbar gastrointestinali.
Consequently, caution should be exercised when Renagel is used in patients with these disorders.
Mela, wieħed għandu joqgħod attent meta Renagel jingħata lill- pazjenti li għandhom dawn il- problemi.
In very rare cases, intestinal obstruction and ileus/ subileus have been observed in patients during treatment with Renagel.
F’ każi rari ħafna, l- imblukkar ta ’ l- intestini u l- ileus/ subileus kienu osservati f’ pazjenti waqt li kienu qed jiġu kkurati b‘ Renagel.
Constipation may be a preceding symptom.
L- istitikezza għandha mnejn tkun sintomu ta ’ qabel.
Patients who are constipated should be monitored carefully while being treated with Renagel.
Il- pazjenti li jbatu b’ stitikezzaix- xedda għandhom ikunu monitorjati bl- attenzjoni waqt li jkunu qed jirċievu l- kura b‘ Renagel.
Renagel treatment should be re- evaluated in patients who develop severe constipation or other severe gastrointestinal symptoms.
Il- kura b’ Renagel għandha terġa ’ tiġi evalwata f’ pazjenti li jiżviluppaw stitikezza severa jew sintomi gastrointestinali severi oħra.
Renagel alone is not indicated for the control of hyperparathyroidism.
Renagel waħdu mhux indikat għall- kontroll ta ’ l- iperparatirojdiżmu.
In patients with secondary hyperparathyroidism Renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 - dihydroxy Vitamin D3 or one of its analogues to lower the intact parathyroid hormone (iPTH) levels.
Fil- każ ta ’ pazjenti li kellhom iperparatirojdiżmu sekondarju, Renagel għandu jintuża fi ħdan il- kuntest ta ’ metodu terapewtiku multiplu, li għandu mnejn jinkludi supplimenti tal- kalċju, 1, 25 – dihydroxy Vitamini D3 jew mill - analogi tiegħu biex ibaxxu il- livelli ta ’ l- ormon paratirojde intatt (iPTH).
Patients with renal insufficiency may develop hypocalcaemia or hypercalcaemia.
Pazjenti li għandhom insuffiċjenza renali għandhom mnejn jiżviluppaw ipokalċaemja jew iperkalċaemja.
Renagel does not contain calcium.
Renagel ma fihx kalċju.
Serum calcium levels should be monitored as is done in normal follow-up of a dialysis patient.
Il- livelli tal- kalċju fis- serum għandhom ikunu monitorjati hekk kif isir fi studju normali ta ’ wara ta ’ pazjent fuq id- dijaliżi.
Elemental calcium should be given as a supplement in case of hypocalcaemia.
Kalċju elementali għandu jingħata bħala suppliment fil- każ ta ’ l- ipokalċaemja.
Depending on diet intake and the nature of end stage renal failure, dialysis patients may develop low vitamin A, D, E and K levels.
Il- pazjenti ta ’ fuq id- dijaliżi għandhom mnejn jiżvillupaw livelli baxxi ta ’ vitamina A, D, E u K.
In preclinical studies, sevelamer at the equivalent of 10 times the maximal human dose has been shown to reduce the absorption of vitamins D, E and K, and folic acid (see also 5.3 Preclinical safety data).
Fi studji ta ’ qabel l - użu kliniku, doża ta ’ sevellamar ekwivalenti daqs 10 darbiet id- doża massima fil- bniedem intweriet li tnaqqas l- assorbiment ta ’ vitamina D, E u K u ta ’ l- aċidu folliku (ara ukoll 5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- medicina).
Therefore, in patients not taking these vitamins, monitoring vitamin A, D and E levels and assessing vitamin K status through the measurement of thromboplastin time should be considered and the vitamins should be supplemented if necessary.
Mela, fil- każ ta ’ pazjenti li mhumiex qed jieħdu dawn il - vitamini, il- monitoraġġ tal- livelli ta ’ Vitamina A, D u E u l- assessjar ta ’ l- istatus ta ’ Vitamina K permezz ta ’ kejl tal- ħin tat- tromboplastin għandu jitqies u l- vitamini għandhom ikunu supplimentati jekk hemm bżonn.
Additional monitoring of vitamins and folic acid is recommended in patients receiving peritoneal dialysis, since in the clinical study, vitamin A, D, E and K levels were not measured in these patients.
Monitoraġġ addizzjonali ta ’ vitamini u aċidu folliku huwa rakkomandat f’ pazjenti li qed jirċievu dijaliżi peritoneali, peress li fl- istudju kliniku, il- livelli ta ’ vitamina A, D, E u K ma ġewx mkejla f’ dawn il- pazjenti.
There is at present insufficient data to exclude the possibility of folate deficiency during long term Renagel treatment.
Bħalissa m’ hawnx biżżejjed tagħrif biex tkun eskluża l- possibbiltà tad- defiċjenza ta ’ folate matul il - kura b‘ Renagel fuq firxa ta ’ żmien twil.
Serum chloride may increase during Renagel treatment as chloride may be exchanged for phosphorus in the intestinal lumen.
Il- livell ta ’ chloride fis- serum għandu mnejn jiżdied matul il- kura b’ Renagel għax chloride jista ’ jinbidel għal phosphate fil- lumen intestinali.
Although no clinically significant serum chloride increase has been observed in the clinical studies, serum chloride should be monitored as is done in the routine follow-up of a dialysis patient.
Minkejja l- fatt li ma kien osservat l- ebda żjieda fil - chloride fis- serum li kien klinikalment sinifikanti fl- istudji kliniċi, chloride fis- serum għandu jkun monitorjat hekk kif isir fl- istudju ta ’ rutina li jsir wara u li jinvolvi pazjent fuq id- dijaliżi.
One gram of Renagel contains approximately 180 mg (5.1mEq) chloride.
Gramma waħda ta ’ Renagel fih bejn wieħed u ieħor 180 mg (5. 1mEq) chloride.
Patients with chronic renal failure are predisposed to developing metabolic acidosis.
3 Pazjenti li għandhom insuffiċjenza kronika huma predisposti li jiżviluppaw aċidosi metabolika.
Worsening of acidosis has been reported upon switching from other phosphate binders to sevelamer in a number of studies where lower bicarbonate levels in the sevelamer-treated patients compared to patients treated with calcium-based binders were observed.
It- tiħżin ta ’ l- aċidosi ġiet rapportata malli kien hemm bdil minn binders tal- fosfat oħrajn għal sevelamer f’ għadd ta ’ studji fejn kienu osservati livelli aktar baxxi ta ’ bikarbonat fil- pazjenti trattati b’ sevelamer meta mqabbla ma ’ pazjenti trattati b’ binders bażati fuq il- kalċju.
Closer monitoring of serum bicarbonate levels is therefore recommended.
Għalhekk huwa rakkomandat li jkun hemm monitoraġġ aktar mill- qrib ta ’ livelli ta ’ bikarbonat fis- serum.
3 Very rare cases of hypothyroidism have been reported in patients co-administered Renagel and Levothyroxine.
Każijiet rari ħafna ta ’ ipotajrojdiżmu ġew rapportati f’ pazjenti li ngħataw Renagel u Levothyroxine.
Closer monitoring of TSH levels is therefore recommended in patients receiving both medicinal products.
Monitoraġġ mill- qrib tal- livelli ta ’ TSH huwa għalhekk rakkomandat f’ pazjenti li qed jieħdu ż- żewġ prodotti mediċinali.
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- puplesija għal kontroll ta ’ disturbi marbuta mal- puplesija ġew esklużi fil- provi kliniċi.
Caution should be exercised when prescribing Renagel to patients also taking these medications.
Attenzjoni għandha tingħata meta Renagel jiġi preskritt lil pazjenti li wkoll qed jieħdu dawn il- mediċini
Patients receiving dialysis are subject to certain risks for infection specific to the dialysis modality.
Pazjenti li qed jirċievi dijaliżi huma suġġetti għal ċertu riskji ta ’ infezzjoni speċifiċi għal mod kif isir id- dijaliżi.
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.
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. 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).
Interaction studies have not been conducted in patients on dialysis.
Ma saru l- ebda studji ta ’ interazzjonijiet fuq pazjenti li qed jirċievu dijaliżi tad- demm.
In interaction studies in healthy volunteers, Renagel had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol.
Skond studji ta ’ interazzjonijiet f’ voluntiera b’ saħħithom, Renagel ma kellu l- ebda effett fuq il - bijodisponibilità ta ’ digoxin, ta ‘ warfarin, ta ’ l- enalapril jew ta’ metoprolol.
However, the bioavailability of ciprofloxacin was decreased by approximately 50% when co-administered with Renagel in a single dose study.
Imma l- bijodisponibilità ta ‘ cipofloxacin tnaqqset b’ madwar 50% meta ingħatat flimkien ma Renagel fi studju ta ’ doża waħda.
Consequently, Renagel should not be taken simultaneously with ciprofloxacin.
Għalhekk, Renagel m’ għandux jittieħed flimkien ma ciprofloxacin.
Renagel may affect the bioavailability of other medicinal products.
Renagel għandu mnejn jaffettwa l- bijodisponibilità ta ’ prodotti mediċinali oħra.
Reduced levels of ciclosporin, mycophenolate mofetil and tacrolimus have been reported in transplant patients when coadministered with Renagel without any clinical consequences (i. e graft rejection).
Livelli mnaqqsa ta ’ ciclosporin, mycophenolate mofetil u tacrolimus ġew irrapportati f’ pazjenti bi trapjant meta ngħata Renagel magħhom mingħajr konsegwenzi kliniċi (i. e. trapjant riġettat).
The possibility of an interaction cannot be excluded and a close monitoring of blood concentrations of mycophenolate mofetil, ciclosporin and tacrolimus should be considered during the use of combination and after its withdrawal.
Il- possibilità ta ’ interazzjoni ma tistax tiġi eskluża u monitoraġġ mill- qrib tal- konċentrazzjonijiet ta ’ mycophenolate mofetil, ciclosporin u tacrolimus fid- demm għandu jiġi kkonsidrat waqt l- użu konġunt u wara li jitwaqqaf.
When administering any medicinal product where a reduction in the bioavailability could have a clinically significant effect on safety or efficacy, the medicinal product should be administered at least one hour before or three hours after Renagel, or the physician should consider monitoring blood levels.
Meta wieħed jagħti kwalunkwe prodott mediċinali fejn it- tnaqqis fil- bijodisponibilità jista ’ jkollu effett klinikalment sinifikanti fuq is- sigurtà u l- effikaċja, il- prodott mediċinali għandu jingħata ta ’ l - anqas siegħa qabel jew tlett sigħat wara Renagel, jew it- tabib għandu jara jekk għandux jiċċekja l - livelli tad- demm.
The safety of Renagel has not been established in pregnant or lactating women.
Is- sigurtà ta ‘ Renagel ma ġietx stabbilita f’ nisa tqal jew li qed irreddgħu.
In animal studies there was no evidence that sevelamer induced embryo-foetal toxicity.
Fi studju fuq annimali ma kien hemm xejn x’ juri li sevelamer ikkaġuna tossiċità fl- embriju- fetu.
Renagel should only be given to pregnant or lactating women if clearly needed and after a careful risk/ benefit analysis has been conducted for both the mother and the foetus or infant (See 5.3 Preclinical safety data).
Ir- Renagel għandu jingħata biss lin- nisa tqal u li qed ireddgħu jekk hu verament meħtieġ u wara li jsir analiżi bir- reqqa tar - riskju/ benefiċċju fuq l- omm u l- fetu jew it- tarbija (ara Sezzjoni 5. 3 Studju qabel l- użu kliniku dwar is - sigurtà tal- medicina).
No studies on the effects on ability to drive and use machines have been performed.
Ma saru ebda studji dwar l- effetti fuq il- ħila ta ’ sewqan u t- tħaddim ta ’ magni.
In parallel design studies involving 244 haemodialysis patients with treatment duration of up to 54 weeks and 97 peritoneal dialysis patients with treatment duration of 12 weeks, the most frequently occurring (≥ 5% of patients) undesirable effects possibly or probably related to Renagel were all in the gastrointestinal disorders system organ class.
Fi studji paralleli pjanati li kien jinvolvi 244 pazjent fuq trattament ta’ emodijaliżi għal sa 54 ġimgħa, u 97 pazjent b’ dijaliżi peritoneali fuq trattament għal 12- il ġimgħa, l- aktar effetti avversi mhux mixtieqa li seħħew (≥ 5% ta ’ pazjenti) li possibilment jew probabilment kienu relatati ma ’ Renagel kienu lkoll disturbi fis- sistema gastrointestinali fis- sistema tal- klassi ta ’ l- organi.
The reporting rate is classified as very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10),
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.
4 uncommon (≥ 1/ 1,000, < 1/ 100), rare (≥ 1/ 10,000, < 1/ 1,000), very rare (< 1/ 10,000), including isolated reports.
Ir- rata ta ’ raportaġġ hi klassifikata bħala komuni ħafna (≥1/ 10), komuni (≥1/ 100,, < 1/ 10), mhux komuni (≥1/ 1, 1000, > 1/ 100), rari (≥1/ 10, 000, 1/ 1, 1000), rari ħafna (< 1/ 10, 000), inkluż ir- rapporti.
Gastrointestinal disorders Very common (≥ 1/ 10):
Disturbi gastrointestinali Komuni ħafna (≥1/ 10):
Diarrhoea, dyspepsia, flatulence, upper abdominal pain, constipation
Nawsea, remettar, Komuni (≥1/ 100 sa < 1/ 10): Dijarea, dispepsja, gass, uġigħ addominali fin- naħa ta ’ fuq, stitikezza
Most of these events are commonly observed in patients Stage 5 Chronic Kidney Disease and are not necessarily attributable to Renagel.
Ħafna minn dawn il- każijiet kienu osservati komunament f’ pazjenti fi Stadju 5 Mard tal- Kliewi Kroniku u mhux neċessarjament seħħu minħabba Renagel
Post-marketing experience:
Esperjenza ta ’ wara d- dħul fis- suq:
In very rare cases, intestinal obstruction and ileus/ subileus have been observed in patients during treatment with Renagel.
F’ każi rari ħafna, l- imblukkar ta ’ l- intestini u l- ileus\ subileus kienu osservati f’ pazjenti waqt li kienu qed jiġu kkurati bir- Renagel.
No case of overdose has been reported.
L- ebda każ ta ’ doza eċċessiva ma ġie rrapurtat.
Renagel has been given to normal healthy volunteers in doses up to 14 grams, the equivalent of thirty- five 403 mg capsules (equivalent to thirty-five 400 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- ħamsa u tletin 400 mg pillola), kuljum għal tmient ijiem mingħajr l- ebda effetti mhux mixtieqa.
Treatment of hyperphosphatemia.
Kura ta ’ l- iperphosphatemija.
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( allylamine hydrochloride) tal- fosfat mhux assorbit li ma fihx metall u kalċju.
It contains multiple amines separated by one carbon from the polymer backbone.
Fih amini multipli li huma separati permezz ta ’ carbon wieħed mill- istruttura ċentrali tal- polimer.
These amines become partially protonated in the intestine and interact with phosphate molecules through ionic and hydrogen bonding.
Dawn l- amini jsiru parzjalment protonati fl- intestin u jinterraġixxu mal- molekuli ta ’ phosphate permezz ta ’ l- għaqda ionika u ta ’ hydrogen bonding.
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 decreases the incidence of hypercalcaemic episodes as compared to patients using calcium based phosphate binders alone, probably because the product itself does not contain calcium.
Sevelamer jnaqqas l- inċidenza tal- każi iperkalċemiċi meta mqabbla ma ’ pazjenti li jużaw biss sustanzi li jorbtu phosphate li huma bbażati fuq il- kalċju, probabbilment minħabba l- fatt li l- prodott innifsu ma fihx kalċju.
The effects on phosphate and calcium were proven to be maintained throughout a study with one year follow-up.
Hemm provi li juru li l- effetti fuq phosphate u kalċju baqgħu jinħassu matul studju li sar sena wara.
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.
Bile acid binding by ion exchange resins is a well-established method of lowering blood cholesterol.
L- irbit ta ’ l- aċidu tal- bile permezz tar- reżini fuq bażi ta ’ skambju joniku hu metodu stabbilit li jintuża biex ibaxxi l- kolesterol tad- demm.
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%.
This effect is observed after 2 weeks is maintained with long-term treatment.
Dan l- effett kien osservat wara 2 ġimgħat u jibqa ’ ikun sostnut bi trattament fit- tul.
Triglycerides, HDL cholesterol and albumin did not change.
It- trigliċeridi, il- kolesterol HDL u l- albumina baqgħu l- istess.
In the clinical studies in haemodialysis patients, sevelamer alone did not have a consistent and clinically significant effect on serum intact parathyroid hormone (iPTH).
5 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).
In the 12 week study involving peritoneal dialysis patients however, similar iPTH reductions were seen compared with patients receiving calcium acetate.
Madankollu, fl- istudju ta ’ 12- il ġimgħa li kien jinvolvi pazjenti fuq dijaliżi peritoneali, tnaqqis iPTH simili kien mqabbel ma pazjenti li qed jirċievu calcium acetate.
In patients with secondary hyperparathyroidism Renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 – dihydroxy Vitamin D3 or one of its analogues to lower the intact parathyroid hormone (iPTH) levels.
Fil- każ ta ’ dawk il- pazjenti li kellhom iperparatirojdiżmu sekondarju, Renagel għandu jintuża fil- kuntest ta ’ metodu terapewtiku multiplu, li jista ’ jinkludi supplimenti ta ’ kalċju, 1, 25 – dihydroxy Vitamin D3 jew wieħed mill- analogi tiegħu biex ibaxxi l- livelli ta ’ l- ormon paratirojde intatt (iPTH).
5 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.
Renagel is not absorbed from the gastrointestinal tract according to a single dose pharmacokinetic study in healthy volunteers.
Skond studju farmakokinetiku ta ’ doża waħda fuq voluntiera b’ saħħithom, irriżulta li Renagel mhuwiex assorbit mis- sistema gastrointestinali.
Pharmacokinetic studies have not been carried out in renal failure patients (see section 4.4 Special warnings and special precautions for use).
Studji farmakokinetiċi ma sarux fuq pazjenti li kellhom insuffiċjenza renali (ara sezzjoni 4. 4 Avviżi speċjali u prekawzjonijiet speċjali għall- użu).
In preclinical studies in rats and dogs, Renagel at a dose of 10 times the maximum human doses reduced absorption of fat soluble vitamins D, E and K, and folic acid.
Skond studji ta ’ qabel l- użu kliniku fuq firien u klieb, meta Renagel ingħata f’ doża ta ’ 10 darbiet id - dożi massimi li jingħataw lill- bnedmin, dan naqqas l- assorbiment ta ’ vitamini liposolubbli D, E u K, u folic acid.
In a study in rats, administering sevelamer in 15-30 x the human dose, an increase in serum copper was detected.
Skond studju fil- firien, l- għoti ta ‘ sevelamer fi 15- 30 x id- doża umana, żjieda f’ copper fis- serum kienet osservata.
This was not confirmed in a dog study or in clinical trials.
Dan ma kienx ikkonfermat fl- ebda studju fuq il- klieb jew fi studji kliniċi.
Currently, no formal carcinogenicity data are available.
Bħalissa, m’ hemm l- ebda tagħrif formali dwar il- karċinoġeniċità.
However, in vitro and in vivo studies have indicated that Renagel does not have genotoxic potential.
Imma, studji in vitro u dawk in vivo indikaw li Renagel ma għandux riskju genotossiku potenzjali.
Also the medicinal product is not absorbed in the gastrointestinal tract.
Barra minn dan, il- prodott mediċinali mhux assorbit fis- sistema gastrointestinali.
In reproduction studies there was no evidence that sevelamer induced embryolethality, foetotoxicity or teratogenicity at the doses tested (up to 1 g/ kg/ day in rabbits and up to 4.5 g/ kg/ day in rats).
M’ hemm xejn x’ juri fl- istudji dwar ir- riproduzzjoni, li sevelamer iżid l- embrijoletalità, il- fetutossiċità jew it- teratoġeniċità fid- dożi ittestjati (sa 1 g/ kg/ kuljum fil- fniek u sa 4. 5 g/ kg/ kuljum fil- firien).
Deficits in skeletal ossification were observed in several locations in fetuses of female rats dosed with sevelamer at 8-20 times the maximum human dose of 200 mg/ kg.
Kienu osservat nuqqas fl- ossifikazzjoni skeletali f’ ħafna partijiet tal- fetu ta ’ firien nisa li ngħataw doża ta ’ sevelamer li kienet bejn 8 u 20 darba aktar mid- doża massima umana ta ’ 200 mg/ kg.
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.
Silica, colloidal anhydrous Stearic acid
Silica colloidal anhydrous Stearic acid
The tablet coating contains:
Ir- rita tal- pillola tikkonsisti minn:
Hypromellose Diacetylated monoglycerides
Hypromellose Diacetylated monoglycerides
The printing ink contains:
Il- linka ta ’ l- istampar fiha:
Iron oxide black (E172) Propylene glycol Hypromellose
Iron oxide black (E172) Propylene glycol Hypromellose.
Do not store above 25ºC.
Taħżinx f’ temperatura ‘ l- fuq minn 25°C.
6 Keep the container tightly closed.
Żomm il- kontenitur magħluq sewwa.
High density polyethylene bottles, with a child resistant polypropylene cap and an induction seal.
Fliexken ta ’ polyethylene ta ’ densità għolja, b’ tap ta ’ polypropylene li ma jistgħux jiftħuh it- tfal b’ siġill ta ’ l- induzzjoni.
400 mg tablets
400 mg pilloli
1 x 360 tablets 2 x 360 tablets 3 x 360 tablets
1 x 360 pillola 2 x 360 pillola 3 x 360 pillola
may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
Any unused product or waste material should be disposed of in accordance with local requirements.
L- ebda ħtiġijiet speċjali Kull fdal tal- prodott li ma jiġix użat jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali
Genzyme Europe B. V., Gooimeer 10, 1411 DD Naarden, The Netherlands
Genzyme Europe B. V., Gooimeer 10, 1411 DD Naarden, l- Olanda
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIŻŻAZZJONI/ TIĠDID TA ’ L- AWTORIŻŻAZZJONI
28/ 01/ 2000 Renewal date:
28/ 01/ 2000 Data ta ’ tiġdid:
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija tal- Mediċini Ewropea (EMEA) http // www. emea. europa. eu /.
Renagel 800 mg film-coated tablets
Renagel 800 mg pilloli miksijin b’ rita
Each tablet contains 800 mg sevelamer.
Kull pillola fiha 800 mg sevelamer.
Film-coated tablet The off-white, oval tablets are imprinted with Renagel 800 on one side.
Pilloli miksijin b’ rita Il- pilloli offwajt, ovali għandhom Renagel 800 stampat fuq naħa waħda.
Renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 – dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
Renagel hu indikat għall- kontroll ta ’ l- iperfosfatemija f’ pazjenti adulti li qed jirċievu dijaliżi tad- demm jew dijaliżi peritoneali. Renagel għandu jintuża fi ħdan kuntest ta ’ metodu terapewtiku multiplu, li jista ’ jinkludi supplimenti tal- kalċju, 1, 25 – dihydroxy Vitamin D3 jew wieħed mill- analogi tiegħu biex jikkontrollaw l- iżvilupp tal- mard ta ’ l- għadam renali.
Serum phosphate level in patients not on Starting dose of Renagel 800
Livell ta ’ fosfat fis- serum
phosphate binders
Doża inizjali tal- pilloli
mg tablets
Renagel 800 mg
1.76 – 2.42 mmol/ l (5.5-7.5 mg/ dl)
1. 76 – 2. 42 mmol/ l (5. 5- 7. 5 mg/ dl) > 2. 42 mmol/ l (> 7. 5 mg/ dl)
1 tablet, 3 times per day
1 pillola, 3 darbiet kuljum 2 pilloli, 3 darbiet kuljum
> 2.42 mmol/ l (> 7.5 mg/ dl)
Jekk Renagel jingħata bir- riċetta tat- tabib għandu jingħata f’ dożi ekwivalenti fuq bażi
2 tablets, 3 times per day
bħala sustanza alternattiva li torbot phosphate, Renagel ta ’ piż f’ mg imqabbel mas- sustanza li torbot il- phosphate
If Renagel is prescribed as an alternative phosphate binder, Renagel should be given in equivalent doses on a mg weight basis compared to the patient’ s previous calcium based phosphate binder.
ibbażata fuq il- kalċju li ngħata qabel lill- pazjent.
Serum phosphate levels should be closely monitored and the dose of Renagel adjusted accordingly with the goal of lowering serum phosphate to 1.76 mmol/ l (5.5 mg/ dl) or less.
Il- livelli ta ’ phosphate fis- serum għandhom ikunu monitorjati sewwa u d- doża ta ’ Renagel għandha tkun aġġustata skond l- objettiv tat- tnaqqis tal - phosphate fis- serum għal 1. 76 mmol/ 1 (5. 5 mg/ dl) jew inqas.
Serum phosphate should be tested every two to three weeks until a stable serum phosphate level is reached and on a regular basis thereafter.
Phosphate fis- serum għandu jkun ittestjat bejn kull ġimgħatejn sa tlett ġimgħat sakemm jintlaħaq livell stabbli ta ’ phosphate fis- serum u fuq bażi regolari wara.
The dose range may vary between 1 and 5 800 mg tablets per meal.
Il- firxa tad- doża tista ’ tvarja bejn 1 u 5 800 mg pillola ma ’ kull ikla.
Patients should take Renagel with meals and adhere to their prescribed diets.
Il- pazjenti għandhom jieħdu Renagel ma ’ l- ikel u josservaw id- dieta preskritta tagħhom.
The tablets must be swallowed whole.
Il- pilloli jridu jinbelgħu sħaħ.
Do not chew.
Tomgħodhomx.
8 4.3 Contra-indications
8 4. 3 Kontra- indikazzjonijiet
• Hypersensitivity to sevelamer or to any of the excipients.. • Hypophosphataemia or bowel obstruction.
• Sensittività eċċessiva għal sevelamer u kwalunkwe sustanzi mhux attivi fil- prodott. • Ipofosfatemija jew imsaren imblukkat.
Efficacy and safety of Renagel has not been studied in children or in predialysis patients.
L- effikaċja u sigurtà ta ’ Renagel ma ġewx studjati fit- tfal, jew f’ pazjenti li qed jirċievu kura tad - dijaliżi peritoneali.
The safety and efficacy of Renagel has not been studied in patients with swallowing disorders, untreated or severe gastroparesis, and retention of gastric contents.
L- effikaċja u sigurtà ta ’ Renagel ma ġewx studjati f’ pazjenti li għandhom problemi biex jibilgħu, gastroparesi li ma ġietx ikkurata jew severa, u żamma tal- kontenut gastriku.
Renagel treatment should be re- evaluated in patients who develop severe constipation or other severe gastrointestinal symptoms.
Il- kura b’ Renagel għandha terġa ’ tiġi evalwata f’ pazjenti li jiżviluppaw stitikezza severa jew sintomi gastrointestinali severi oħra
Additional monitoring of vitamins and folic acid is recommended in patients receiving peritoneal dialysis, since in the clinical study, vitamin A, D, E and K levels were not measured in these patients.
Monitoraġġ addizzjonali ta ’ vitamini u aċidu folliku huwa rakkomandat f’ pazjenti li qed jirċievu dijaliżi peritoneali, peress li fl- istudju kliniku, il- livelli ta ’ vitamina A, D, E u K ma ġewx imkejla f’ dawn il- pazjenti.
Patients with chronic renal failure are predisposed to developing metabolic acidosis.
Pazjenti li għandhom insuffiċjenza kronika huma predisposti li jiżviluppaw aċidosi metabolika.
Worsening of acidosis has been reported upon switching from other phosphate binders to sevelamer in a number of studies where lower bicarbonate levels in the sevelamer-treated patients compared to patients treated with calcium-based binders were observed.
It- tiħżin ta ’ l- aċidosi ġiet rapportata malli kien hemm bdil minn binders tal- fosfat oħrajn għal 9 sevelamer f’ għadd ta ’ studji fejn kienu osservati livelli aktar baxxi ta ’ bikarbonat fil- pazjenti trattati b’ sevelamer meta mqabbla ma ’ pazjenti trattati b’ binders bażati fuq il- kalċju.
9 Very rare cases of hypothyroidism have been reported in patients co-administered Renagel and Levothyroxine.
Każijiet rari ħafna ta ’ ipotajrojdiżmu ġew rapportati f’ pazjenti li ngħataw Renagel u Levothyroxine.