qanastek/EMEA-V3 huggingface dataset:
What MIRAPEXIN looks like and contents of the pack MIRAPEXIN 0.088 mg tablets are white, round, flat, embossed with a code, without scoring.
Id- dehra ta ’ MIRAPEXIN u l- kontenuti tal- pakkett Il- pilloli MIRAPEXIN 0. 088 mg huma bojod, tondi, ċatti, imnaqqxa b’ kodiċi, mingħajr ferq.
MIRAPEXIN is available in aluminium blister strips of 10 tablets per strip, in cartons containing 3 or 10 blister strips (30 or 100 tablets).
MIRAPEXIN hu disponibbli fi strixxi bil- folji ta ’ l- aluminju ta ’ 10 pilloli f’ kull strixxa, f’ kaxxi tal- kartun li fihom 3 jew 10 strixxi bil- folji (30 jew 100 pillola).
Marketing Authorisation Holder Boehringer Ingelheim International GmbH D-55216 Ingelheim am Rhein Germany
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq Boehringer Ingelheim International GmbH D- 55216 Ingelheim am Rhein Il- Ġermanja
Manufacturer Boehringer Ingelheim Pharma GmbH & Co.
Manifattur Boehringer Ingelheim Pharma GmbH & Co.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
93 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
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94
This leaflet was last approved on {date}
Dan il- fuljett kien approvat l- aħħar fi {data}
- 95 -
95 FULJETT TA ’ TAGĦRIF:
MIRAPEXIN 0.18 mg tablets pramipexole
MIRAPEXIN 0. 18 mg pilloli pramipexole
- treat the symptoms of moderate to severe primary Restless Legs Syndrome (RLS).
- jikkura s- sintomi tas- Sindrome tas- Saqajn Bla Kwiet (Restless Legs Syndrome - RLS) primarju
- kidney disease.
- mard tal- kliewi
increased sexual desire), binge eating.
aptit sesswali), tiekol bl- addoċċ.
- psychosis, (e. g. comparable with symptoms of schizophrenia)
- psikosi, (eż. komparabbli ma ’ sintomi ta ’ l- iskiżofrenja)
- vision impairment
- Indeboliment fil- vista
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96 Għandhom isirulek eżamijiet regolari ta ’ l- għajnejn eżamijiet matul il- kura b’ MIRAPEXIN.
This is to avoid postural hypotension (a fall in blood pressure on standing up)
Dan biex tiġi evitata pressjoni tad- demm baxxa li tiddependi mill- qagħda (il - pressjoni tad- demm titbaxxa malli tqum bilwieqfa)
Take care if you are using any medicines that calm you down (have a sedative effect) or if you are drinking alcohol.
Oqgħod attenta/ a jekk qed tuża kwalunkwe mediċini li jikkalmawk (għandhom effett sedattiv) jew jekk qed tixrob l- alkoħol.
Important information about some of the ingredients of MIRAPEXIN tablets MIRAPEXIN tablets contain mannitol.
Tagħrif importanti dwar xi wħud mis- sustanzi tal- pilloli MIRAPEXIN Il- pilloli MIRAPEXIN fihom il- mannitol.
1 tablet MIRAPEXIN
1 pillola MIRAPEXIN 0. 088 mg tliet darbiet kuljum
The usual maintenance dose is 1,1 mg per day.
Id- doża normali tal- manteniment hi ta ’ 1. 1 mg darba kuljum.
Restless Legs Syndrome The dose is usually taken once a day, in the evening, 2-3 hours before bedtime.
98 Normalment id- doża titttieħed darba kuljum, filgħaxija, 2- 3 sigħat qabel il- ħin ta ’ l- irqad.
2 tablets MIRAPEXIN
1 pillola
OR
MIRAPEXIN 0. 18 mg
OR
2 pilloli MIRAPEXIN 0. 18 mg JEW
4 tablets MIRAPEXIN 0.088 mg
4 pilloli MIRAPEXIN 0. 088 mg
3 tablets MIRAPEXIN 0.18 mg OR 6 tablets MIRAPEXIN 0.088 mg
3 pilloli MIRAPEXIN 0. 18 mg JEW 6 pilloli MIRAPEXIN 0. 088 mg
If you stop taking MIRAPEXIN Do not stop taking MIRAPEXIN without first talking to your doctor.
Jekk tieqaf tieħu MIRAPEXIN Tiqafx tieħu MIRAPEXIN mingħajr ma l- ewwel titkellem mat- tabib tiegħek.
If you suffer from Parkinson’ s disease you should not stop treatment with MIRAPEXIN abruptly.
99 Jekk tbati mill- marda ta ’ Parkinson, m’ għandekx twaqqaf il- kura b’ MIRAPEXIN f’ daqqa.
These symptoms include:
Dawn is- sintomi jinkludu:
If you suffer from Parkinson’ s disease, you may experience the following side effects:
Jekk tbati mill- Marda ta ’ Parkinson, jista ’ jkollok dawn l- effetti sekondarji
Each MIRAPEXIN 0.18 mg tablet contains 0.18 mg of pramipexole base (as 0.25 mg of pramipexole dihydrochloride monohydrate).
Kull pillola MIRAPEXIN 0. 18 mg fiha 0. 18 mg ta ’ bażi ta ’ pramipexole bħala 0. 25 mg ta ’ pramipexole dihydrochloride monohydrate).
What MIRAPEXIN looks like and contents of the pack MIRAPEXIN 0.18 mg tablets are white, oval, flat, embossed with a code.
Id- dehra ta ’ MIRAPEXIN u l- kontenuti tal- pakkett Il- pilloli MIRAPEXIN 0. 18 mg huma bojod, ovali, ċatti, imnaqqxa b’ kodiċi.
Tablets are scored and breakable in half.
Il- pilloli għandhom ferq u jistgħu jinqasmu min- nofs.
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102 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
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104 FULJETT TA ’ TAGĦRIF:
MIRAPEXIN 0.35 mg tablets pramipexole
MIRAPEXIN 0. 35 mg pilloli pramipexole
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105 Għandhom isirulek eżamijiet regolari ta ’ l- għajnejn eżamijiet matul il- kura b’ MIRAPEXIN.
Restless Legs Syndrome The dose is usually taken once a day, in the evening, 2-3 hours before bedtime.
107 Normalment id- doża titttieħed darba kuljum, filgħaxija, 2- 3 sigħat qabel il- ħin ta ’ l- irqad.
If you take more MIRAPEXIN than you should If you accidentally take too many tablets
Jekk tieħu MIRAPEXIN aktar milli suppost Jekk aċċidentalment tieħu pilloli żejda
(Possible side effects)
deskritti f’ Kapitlu 4 (Effetti sekondarji li jista ’ jkollu).
If you suffer from Parkinson’ s disease you should not stop treatment with MIRAPEXIN abruptly.
108 Jekk tbati mill- marda ta ’ Parkinson, m’ għandekx twaqqaf il- kura b’ MIRAPEXIN f’ daqqa.
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- deni
Each MIRAPEXIN 0.35 mg tablet contains 0.35 mg of pramipexole base (as 0.5 mg of pramipexole dihydrochloride monohydrate).
Kull pillola MIRAPEXIN 0. 35 mg fiha 0. 35 mg ta ’ bażi ta ’ pramipexole (bħala 0. 5 mg ta ’ pramipexole dihydrochloride monohydrate).
What MIRAPEXIN looks like and contents of the pack MIRAPEXIN 0.35 mg tablets are white, oval, flat, embossed with a code.
Id- dehra ta ’ MIRAPEXIN u l- kontenuti tal- pakkett Il- pilloli MIRAPEXIN 0. 35 mg huma bojod, ovali, ċatti, imnaqqxa b’ kodiċi.
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111 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
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113 FULJETT TA ’ TAGĦRIF:
MIRAPEXIN 0.7 mg tablets pramipexole
MIRAPEXIN 0. 7 mg pilloli pramipexole
Stimulation of the dopamine receptors triggers nerve impulses in the brain that help to control body movements.
L- istimulazzjoni tar- riċetturi ta ’ dopamine tikkawża impulsi tan - nervituri fil- moħħ li jgħinu biex jikkontrollaw il- movimenti tal- ġisem.
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114 Għandhom isirulek eżamijiet regolari ta ’ l- għajnejn eżamijiet matul il- kura b’ MIRAPEXIN.
Always take MIRAPEXIN exactly as your doctor has told you.
KIF TUŻA MIRAPEXIN Dejjem għandek tieħu MIRAPEXIN skond il- parir tat- tabib.
Restless Legs Syndrome The dose is usually taken once a day, in the evening, 2-3 hours before bedtime.
Sindrome tas- Saqajn Bla Kwiet Normalment id- doża titttieħed darba kuljum, filgħaxija, 2- 3 sigħat qabel il- ħin ta ’ l- irqad.
During the first week, the usual dose is 1 tablet MIRAPEXIN 0.088 mg once a day (equivalent to 0.088 mg daily):
116 Matul l- ewwel ġimgħa, id- doża normali hi ta ’ pillola waħda ta ’ MIRAPEXIN 0. 088 mg darba kuljum (ekwivalenti għal 0. 088 mg kuljum):
OR
MIRAPEXIN 0. 18 mg JEW
If you suffer from Parkinson’ s disease you should not stop treatment with MIRAPEXIN abruptly.
117 Jekk tbati mill- marda ta ’ Parkinson, m’ għandekx twaqqaf il- kura b’ MIRAPEXIN f’ daqqa.
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- deni
If you suffer from Parkinson’ s disease, you may experience the following side effects:
Jekk tbati mill- Marda ta ’ Parkinson, jista ’ jkollok dawn l- effetti sekondarji Komuni ħafna:
Each MIRAPEXIN 0.7 mg tablet contains 0.7 mg of pramipexole base (as 1 mg of pramipexole dihydrochloride monohydrate).
Kull pillola MIRAPEXIN 0. 7 mg fiha 0. 7 mg ta ’ bażi ta ’ pramipexole (bħala 1 mg ta ’ pramipexole dihydrochloride monohydrate).
What MIRAPEXIN looks like and contents of the pack MIRAPEXIN 0.7 mg tablets are white, round, flat, embossed with a code.
Id- dehra ta ’ MIRAPEXIN u l- kontenuti tal- pakkett Il- pilloli MIRAPEXIN 0. 7 mg huma bojod, tondi, ċatti, imnaqqxa b’ kodiċi.
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120 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
- 122 -
122 FULJETT TA ’ TAGĦRIF:
MIRAPEXIN 1.1 mg tablets pramipexole
MIRAPEXIN 1. 1 mg pilloli pramipexole
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123 Għandhom isirulek eżamijiet regolari ta ’ l- għajnejn eżamijiet matul il- kura b’ MIRAPEXIN.
3.
124 3.
Restless Legs Syndrome The dose is usually taken once a day, in the evening, 2-3 hours before bedtime.
125 Sindrome tas- Saqajn Bla Kwiet Normalment id- doża titttieħed darba kuljum, filgħaxija, 2- 3 sigħat qabel il- ħin ta ’ l- irqad.
If you suffer from Parkinson’ s disease you should not stop treatment with MIRAPEXIN abruptlyA sudden stop could cause you to develop a medical condition called neuroleptic malignant syndrome which may represent a major health risk.
It- twaqqif f’ daqqa jista ’ jkun il- kawża li tiżviluppa kundizzjoni medika msejħa sindrome malinn newroleptiku li jista ’ jirrappreżenta riskju maġġuri għas- saħħa.
- 126 -
- deni
Each MIRAPEXIN 1.1 mg tablet contains 1.1 mg of pramipexole base (as 1.5 mg of pramipexole dihydrochloride monohydrate).
Kull pillola MIRAPEXIN 1. 1 mg fiha 1. 1 mg ta ’ bażi ta ’ pramipexole (bħala 1. 5 mg ta ’ pramipexole dihydrochloride monohydrate).
What MIRAPEXIN looks like and contents of the pack MIRAPEXIN 1.1 mg tablets are white, round, flat, embossed with a code.
Id- dehra ta ’ MIRAPEXIN u l- kontenuti tal- pakkett Il- pilloli MIRAPEXIN 1. 1 mg huma bojod, tondi, ċatti, imnaqqxa b’ kodiċi, b’ ferq.
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129 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHOM JIĠU MPLIMENTATI MILL- ISTATI MEMBRI
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHOM JIĠU MPLIMENTATI MILL- ISTATI MEMBRI
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented.
L- Istati Membri għandhom jiżguraw li l- kundizzjonijiet jew restrizzjonijiet fir- rigward ta ’ użu sikur u effettiv tal- prodott mediċinali deskritti taħt jiġu mplimentati kollha.
The MAH shall provide physicians prior to launch with an educational material that will include the following components of information: • Need and clinical importance of adverse drug reaction (ADR) reporting in general. • Background data on erythropoietin antibody-mediated pure red cell aplasia (AEAB-mediated PRCA) associated with erythropoiesis stimulating agents (ESA) treatment. • List of diagnoses or adverse events (AE) terms that trigger ADR reporting for MIRCERA. • A questionnaire to gather detailed ADR report documentation. • The MAH’ s offer of testing or re-testing antibody (AB) status in a reference laboratory. • Literature to provide information on loss of effect and its differential causes, the definition of AEAB-mediated PRCA, the diagnostic work-up of potential AEAB-mediated PRCA, the need of discontinuation of ESA treatment due to cross-reactivity with other ESAs on diagnosis of AEAB-mediated PRCA..
Qabel it- tqegħid fis- suq, id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jipprovdi lit- tobba materjal ta ’ edukazzjoni li jkun jinkludi l- komponenti ta ’ informazzjoni li ġejjin: • Il- bżonn u l- importanza klinika ġenerali li jiġu rrappurtati reazzjonijiet avversi tal- mediċina (ADR). • Tagħrif ġenerali dwar aplasija pura taċ- ċelloli l- ħomor ikkawżata minn antikorpi għall - eritropoetin (PRCA ikkawżata minn AEAB) assoċjata ma ’ kura b’ sustanzi li jistimulaw l - eritropoesi (ESA). • Lista ta ’ terminoloġija ta ’ dijanjosi jew ta ’ avvenimenti avversi (AE) li jwasslu għal rapport ta ’ ADR għal MIRCERA. • Kwestjonarju biex tinġabar dokumentazzjoni dettaljata ta ’ rapport ta ’ ADR. • L- offerta tad- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq li jeżamina jew jeżamina mill- ġdid l- istat ta ’ l- antikorpi (AB) fl- laboratorju ta ’ referenza. • Letteratura biex tipprovdi informazzjoni dwar it- telf ta ’ effett u l- kawżi differenzjali ta ’ dan, definizzjoni ta ’ PRCA ikkawżata minn AEAB, attivitajiet li jwasslu għal dijanjosi ta ’ PRCA ikkawżata minn AEAB potenzjali, l- bżonn li titwaqqaf il- kura ta ’ ESA wara dijanjosi ta ’ PRCA ikkawżata minn AEAB minħabba reazzjoni nkroċjata ma ’ ESAs oħrajn.
What is MIRCERA?
X’ inhu MIRCERA?
MIRCERA is a solution for injection, which contains the active substance methoxy polyethylene glycol-epoetin beta.
MIRCERA huwa soluzzjoni għall- injezzjoni, li fiha s- sustanza attiva methoxy polyethylene glycol - epoetin beta.
It is available in vials and in pre-filled syringes at various strengths ranging between 50 and 1,000 micrograms per millilitre.
Jiġi fi fjali u f’ siringi mimlija għal- lest f’ diversi konċentrazzjonijiet li jvarjaw bejn 50 u 1, 000 mikrogramma kull millilitru.
What is MIRCERA used for?
Għal x’ hiex jintuża MIRCERA?
MIRCERA is used to treat anaemia (low red blood cell counts) in patients who have chronic kidney disease (long-term, progressive decrease in the ability of the kidneys to work properly).
MIRCERA jintuża fit- trattament ta ’ l- anemija (nuqqas ta ’ ċelloli ħomor tad- demm) fil- pazjenti li jkollhom mard kroniku tal- qalb (tnaqqis progressiv u fit- tul milli l- kliewi jibqgħu jaħdmu sew).
How is MIRCERA used?
Kif jintuża MIRCERA?
Treatment with MIRCERA must be initiated under the supervision of a doctor who has experience in the management of patients with kidney disease.
It- trattament b’ MIRCERA għandu jinbeda bis- sorveljanza ta ’ tabib li jkollu esperjenza fil- ġestjoni ta ’ pazjenti bil- mard tal- kliewi.
The starting dose and the frequency of dosing depend on whether MIRCERA is replacing another medicine used to stimulate the production of red blood cells or not.
Id- doża inizjali u l- frekwenza tad- doża tiddependi minn jekk MIRCERA jkunx qed jissostitwixxi mediċina oħra użata biex tistimula l- produzzjoni taċ- ċelloli ħomor tad- demm jew le.
Patients who have not been receiving one of these medicines need to start with a dose of 0.6 micrograms per kilogram body weight twice a month.
Il- pazjenti li ma jkunux qed jirċievu xi waħda minn dawn il- mediċini jkunu jridu jibdew b’ doża ta ’ 0. 6 mikrogrammi għal kull kilogramma li jiżnu darbtejn fix- xahar.
Patients who have been receiving one of these medicines need to receive MIRCERA once a month, with the dose ranging between 120 and 360 micrograms.
Il- pazjenti li jkunu qed jieħdu dawn il- mediċini jkollhom jieħdu MIRCERA darba fix- xahar, bid- doża tvarja bejn 120 u 360 mikrogramma.
See the Summary of Product Characteristics (also part of the EPAR) for full details.
Ara s- Sommarju tal- Karatteristiċi tal- Prodott (ukoll parti mill- EPAR) għad- detallji kollha.
In all cases, doses should be adjusted depending on the levels of haemoglobin (a protein in red blood cells that carries oxygen around the body), which should be monitored every two weeks until they are stable, and then periodically.
Fil- każi kollha, id- dożi għandhom jiġu aġġustati skond il- livelli ta ’ l- emoglobina (proteina fiċ - ċelloli ħomor tad- demm li ġġorr l- ossiġenu madwar il- ġisem, li għandhom jiġu kkontrollati kull ġimagħtejn sakemm jistabbilizzaw, u mbagħad perjodikament.
MIRCERA is intended for long-term use.
MIRCERA għandu jintuża għal użu fit - tul.
MIRCERA is given as an injection, either subcutaneously (under the skin) or intravenously (into a vein).
MIRCERA jingħata b’ injezzjoni, jew taħt il- ġilda jew fil- vina.
Patients can inject themselves subcutaneously or intravenously through a haemodialysis line (a tube leading into a vein) once they have been trained.
Il- pazjenti jistgħu jinjettaw il- mediċina lilhom infushom jew taħt il- ġilda jew fil- vina minn ġo tubu ta ’ l- emodijaliżi jekk ikunu ġew imħarrġa biex jagħmlu dan.
MIRCERA should be used with caution in patients who have severe problems with their liver.
MIRCERA għandu jintuża b’ kawtela f’ pazjenti li jkollhom problemi severi fil - fwied.
It is not recommended for use in children, due to a lack of information on the safety and effectiveness of the medicine in this group.
Mhux rakkomandat għall- użu fit- tfal, minħabba nuqqas ta ’ tagħrif dwar is- sigurtà u l- effettività ta ’ din il- mediċina fit- tfal.
How does MIRCERA work?
Kif jaħdem MIRCERA?
A hormone called erythropoietin stimulates the production of red blood cells from the bone marrow.
L- ormon magħruf bħala eritropoetina jistimula l- produzzjoni taċ- ċelloli ħomor tad- demm mill - mudullun.
Erythropoietin is produced by the kidneys, and patients with chronic kidney disease have a lack of erythropoietin, causing anaemia.
L- eritropoetina tiġi prodotta mill- kliewi, u l- pazjenti li jkollhom mard kroniku fil- kliewi jkollhom nuqqas ta ’ eritropoetina, u dan jikkawża anemija.
The way it interacts with the receptor is slightly 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Is- sustanza attiva f’ MIRCERA, methoxy polyethylene glycol- epoetin beta, tista ’ tistimula l- produzzjoni taċ- ċelloli ħomor tad- demm bħalma 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged different from natural erythropoietin, and this gives it a longer effect.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged tagħmel l- eritropoetina.
It is also cleared from the body less quickly.
Dan isir għax is- sustanza attiva tista ’ teħel ma ’ l- istess riċetturi li teħel magħhom l- eritropoetina.
As a result, it can be given less often than other medicines derived from erythropoietin.
Minħabba f’ hekk, jista ’ jingħata inqas spiss minn mediċini oħra derivati mill- eritropoetina.
The active substance in MIRCERA is made up of epoetin beta bound to a chemical called methoxy- polyethylene glycol.
Is- sustanza attiva f’ MIRCERA hi magħmula minn epoetin beta mwaħħel ma ’ kimika magħrufa bħala methoxy- polyethylene glycol.
The epoetin beta is produced by ‘ recombinant DNA technology’: it is made by a cell that has received a gene, which makes it able to produce epoetin beta.
L- epoetin beta jiġi prodott permezz tat - ‘ teknoloġija rikombinanti tad - DNA ’: jiġi manifatturat minn ċellola li tkun irċeviet ġene li jagħmilha kapaċi tipproduċi l- epoetin beta.
How has MIRCERA been studied?
Kif ġie studjat MIRCERA?
The effects of MIRCERA were first tested in experimental models before being studied in humans.
L- effetti ta ’ MIRCERA għall- ewwel ġew ittestjati f’ mudelli esperimentali qabel ma ġew studjati fil - bniedem.
MIRCERA has been studied in six main studies involving a total of 2,399 adults with anaemia associated with chronic kidney disease, where it was compared with other medicines used to stimulate red blood cell production.
MIRCERA ġie studjat f’ sitt studji ewlenin li fihom b’ kollox ħadu sehem 2, 399 adult bl- anemija assoċjata mal- mard kroniku tal- kliewi, fejn tqabbel ma ’ mediċini oħra użati biex jistimulaw il - produzzjoni taċ- ċelloli ħomor tad- demm.
Two of these studies involved patients who were starting treatment for anaemia.
Fi tnejn minn dawn l- istudji ħadu sehem pazjenti li kienu qed jibdew trattament għall- anemija.
The first, in 181 patients on dialysis (a blood clearance technique used in advanced chronic kidney disease), looked at MIRCERA injected intravenously every two weeks over 24 weeks and compared it with epoetin alfa or beta.
L- ewwel wieħed, bis- sehem ta ’ 181 pazjent li kienu qed jagħmlu dijaliżi (teknika ta ’ tneħħija tad- demm użata f’ pazjenti b’ mard tal- kliewi kroniku avvanzat), studja MIRCERA injettat fil- vina kull ġimagħtejn għal 24 ġimgħa u qabblu ma ’ epoetin alfa jew beta.
The second study, in 324 patients not on dialysis, looked at MIRCERA injected subcutaneously every two weeks over 28 weeks, comparing it with darbepoetin alfa.
It- tieni studju, li fih ħadu sehem 324 pazjent li ma kinux qed jagħmlu d- dijaliżi, studja MIRCERA injettat taħt il- ġilda kull ġimagħtejn għal 28 ġimgħa, u qabblu ma ’ darbepoetin alfa.
The other four studies (in 1,894 patients) were carried out in patients on dialysis who had already been receiving medicines to stimulate red blood cell production.
L- erba ’ studji l- oħra (bis- sehem ta ’ 1, 894 pazjent) saru f’ pazjenti li kienu qed jagħmlu d- dijaliżi li kienu diġà qed jieħdu mediċini biex jistimulaw il- produzzjoni taċ- ċelloli ħomor tad- demm.
In these studies, patients either remained on the medicines they were already receiving, or changed to MIRCERA, given intravenously or subcutaneously every two or four weeks, and the effectiveness of the two treatment options was compared.
F’ dawn l - istudji, il- pazjenti baqgħu jieħdu l- istess mediċini li kienu diġà qed jieħdu, jew minflok bdew jieħdu MIRCERA, mogħti fil- vina jew taħt il- ġilda kull ġimagħtejn jew erba ’ ġimgħat, u tqabblet l- effettività taż- żewġ trattamenti.
The studies lasted 36 weeks.
L- istudji damu 36 ġimgħa.
In all six studies, the main measure of effectiveness was the change in haemoglobin levels.
Fis- sitt studji li huma, il- mezz ewlieni tal- kejl ta ’ l- effettività kien it- tibdil fil- livelli ta ’ l- emoglobina.
Most patients also received iron to prevent deficiency (low iron levels) during the studies.
Il- biċċa l- kbira tal- pazjenti ngħataw ukoll il- ħadid biex tkun evitata d- defiċjenza (livelli baxxi ta ’ ħadid) waqt l- istudji.
What benefit has MIRCERA shown during the studies?
X’ inhuma l- benefiċċji ta ’ MIRCERA li ntwerew f’ dawn l- istudji?
MIRCERA was as effective as the comparator medicines in correcting and maintaining haemoglobin levels.
MIRCERA kien effettiv daqs il- mediċini li tqabbel magħhom fl- irranġar u ż- żamma tal- livelli ta ’ l - emoglobina.
In the studies of patients starting treatment for anaemia for the first time, 126 (93%) of the 135 patients receiving MIRCERA in the first study, and 158 (98%) of the 162 receiving it in the second had a clinically significant increase in haemoglobin levels between the start and end of the studies.
Fl- istudji ta ’ pazjenti li kienu qed jibdew it- trattament għall- anemija għall- ewwel darba, 126 (93%) tal- 135 pazjent li kienu qed jieħdu MIRCERA fl- ewwel studju, u 158 (98%) tal- 162 li kienu qed jiħduh fit- tieni studju kellhom żieda klinikament sinjifikanti fil- livelli ta ’ l- emoglobina bejn il- bidu u t- tmiem ta ’ l- istudji.
Similar response rates were seen in the patients taking the comparator medicines.
Kien hemm rati ta ’ rispons simili fil- pazjenti li kienu qed jieħdu l - mediċini tat- tqabbil.
The second study showed that patients taking MIRCERA and those taking darbepoetin alfa had similar increases in haemoglobin levels (around 2 g/ dl).
It- tieni studju wera li l- pazjenti li kienu qed jieħdu MIRCERA u dawk li kienu qed jieħdu darbepoetin alfa kellhom żidiet simili fil- livelli ta ’ l- emoglobina (madwar 2 g/ dl).
In the studies of patients who had already been receiving medicines to stimulate red blood cell production, patients who changed to MIRCERA maintained their haemoglobin levels as effectively as the patients who remained on their existing medicines.
Fl- istudji ta ’ pazjenti li kienu diġà qed jieħdu mediċini li jistimulaw il- produzzjoni ta ’ ċelloli tad - demm ħomor, il- pazjenti li bdew jieħdu MIRCERA minflok il- mediċina l- oħra effettivament żammew il- livelli ta ’ l- emoglobina daqs il- pazjenti li baqgħu jieħdu l- mediċini ta ’ qabel.
There was no overall change in haemoglobin levels over the course of these studies with any of the treatments.
Ma kienx hemm tibdil globali fil- livelli ta ’ l- emoglobina matul dawn l- istudju fl- ebda wieħed mit- trattamenti.
What is the risk associated with MIRCERA?
X’ inhu r- riskju assoċjat ma ’ MIRCERA?
The most common side effect with MIRCERA (seen in between 1 and 10 patients in 100) is hypertension (high blood pressure).
L- iktar effett sekondarju komuni tat- teħid ta ’ MIRCERA (li deher f’ bejn pazjent wieħed u għaxra minn kull mija) hu l- pressjoni għolja.
For the full list of all side effects reported with MIRCERA, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati ma ’ MIRCERA, ara l- Fuljett ta ’ Tagħrif.
MIRCERA should not be used in people who may be hypersensitive (allergic) to methoxy polyethylene glycol-epoetin beta or any of the other ingredients.
MIRCERA m’ għandux jingħata lil persuni li jkollhom allerġija għal methoxy polyethylene glycol - epoetin beta jew għal xi sustanza oħra tiegħu.
It should also not be used in patients who have hypertension that is not controlled.
Lanqas ma għandu jingħata lil pazjenti li jkollhom pressjoni għolja mhux ikkontrollata.
Why has MIRCERA been approved?
Għaliex ġie approvat MIRCERA?
The Committee for Medicinal Products for Human Use (CHMP) concluded that MIRCERA corrected and maintained haemoglobin levels in patients with chronic kidney disease and that its effects are comparable with those of other epoetins.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li MIRCERA irranġa u żamm tajbin il- livelli ta ’ l- emoglobina f’ pazjenti b’ mard kroniku tal- kliewi u li l- effetti tiegħu jistgħu jitqabblu ma ’ dawk ta ’ epoetins oħra.
It decided that MIRCERA’ s benefits are greater than its risks for the treatment of anaemia associated with chronic kidney disease.
Iddeċieda li l- benefiċċji ta ’ MIRCERA fit - trattament ta ’ anemija assoċjata ma ’ mardiet kroniċi tal- kliewi huma ikbar mir- riskji tiegħu.
The Committee recommended that MIRCERA be given marketing authorisation.
Il- Kumitat irrakkomanda li MIRCERA jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
against erythropoietin (these antibodies may develop during treatment and can reduce its effectiveness).
Il- kumpanija se tipprovdi wkoll, lit- tobba li jitolbuha, ittestjar b’ xejn għall- antikorpi ta ’ kontra l- eritropoetina (dawn l- antikorpi jistgħu jiżviluppaw waqt it- trattament u jistgħu inaqqsu l- effettività tiegħu).
Other information about MIRCERA:
Tagħrif ieħor dwar MIRCERA:
The European Commission granted a marketing authorisation valid throughout the European Union for MIRCERA to Roche Registration Limited on 20 July 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- UE kollha għal MIRCERA lil Roche Registration Limited fil- 20 ta ’ Lulju 2007.
The full EPAR for MIRCERA can be found here.
L- EPAR sħiħ dwar MIRCERA jista ’ jinstab hawnhekk.
This summary was last updated in 06-2007.
Dan is- sommarju kien aġġornat l- aħħar f’ 06- 2007.
Invented name
Isem inventat Isem
Mircera
MIRCERA
pre-filled syringe (glass)
siringa mimlija għal - lest (ħġieġ)
0.3 ml (167 µg/ ml)
0. 3 ml (167 µg / ml)
1 pre-filled syringe
siringa mimlija għal - lest waħda
0.3 ml (250 µg/ ml)
0. 3 ml (250 µg / ml)
0.3 ml (333 µg/ ml)
0. 3 ml (333 µg / ml)
1 pre-filled syringe
siringa mimlija għal - lest waħda siringa mimlija għal -
Subcutaneous or intravenous use
Użu għal taħt il- ġilda jew
pre-filled syringe (glass)
siringa mimlija għal -
0.3 ml (500 µg/ ml)
0. 3 ml (500 µg / ml)
1 pre-filled syringe
għal ġol- vini
0.3 ml (667 µg/ ml)
0. 3 ml (667 µg / ml)
0.3 ml (833 µg/ ml)
0. 3 ml (833 µg / ml)
0.6 ml (667 µg/ ml)
0. 6 ml (667 µg / ml)
0.6 ml (1000 µg/ ml)
0. 6 ml (1000 µg / ml)
0.6 ml (1333 µg/ ml)
0. 6 ml (1333 µg / ml)
30 µg/ 0.3 ml
30 µg/ 0. 3 ml
40 µg/ 0.3 ml
40 µg/ 0. 3 ml
pre-filled syringe (glass)
siringa mimlija għal - 0. 3 ml (200 µg / ml) lest (ħġieġ)
pre-filled syringe (glass)
siringa mimlija għal - 0. 3 ml (400 µg / ml) lest (ħġieġ)
0.6 ml (600 µg/ ml)
siringa mimlija għal - 0. 6 ml (600 µg / ml) lest (ħġieġ)
MIRCERA 50 micrograms/ ml solution for injection
MIRCERA 50 mikrogramma/ ml soluzzjoni għall- injezzjoni
1 ml (one vial) contains 50 micrograms of methoxy polyethylene glycol-epoetin beta*.
1 ml (kunjett wieħed) fih 50 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta *.
The strength indicates the quantity of the protein moiety of the methoxy polyethylene glycol-epoetin beta molecule without consideration of the glycosylation.
Il- qawwa tindika l- kwantità tal- parti minn proteina fil- molekula ta ’ methoxy polyethylene glycol- epoetin beta mingħajr konsiderazzjoni tal- glikolsilazzjoni.
*Protein produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells and covalently conjugated to a linear methoxy-polyethylene glycol (PEG).
* Proteina magħmula permezz ta ’ teknoloġija rikombinanti tad- DNA f’ ċelluli ta ’ l- Ovarju ta ’ Ħamster Ċiniż (CHO) u kkonjugata b’ mod kovalenti ma ’ methoxy- polyethylene glycol (PEG) lineari.
The potency of methoxy polyethylene glycol-epoetin beta should not be compared to the one of another pegylated or non-pegylated protein of the same therapeutic class.
Il- qawwa ta ’ methoxy polyethylene glycol- epoetin beta m’ għandhiex titqabbel ma ’ dik ta ’ proteina oħra, pegylated jew mhux pegylated, ta ’ l- istess klassi terapewtika.
For more information, see section 5.1.
Għal aktar tagħrif, ara sezzjoni 5. 1.
The solution is clear and colourless to slightly yellowish.
Is- soluzzjoni hija ċara u mingħajr kulur għal kemmxejn safranija.
Treatment of symptomatic anaemia associated with chronic kidney disease (CKD).
Kura ta ’ anemija sintomatika assoċjata ma ’ marda kronika tal- kliewi (CKD).
The safety and efficacy of MIRCERA therapy in other indications has not been established.
Is- sigurtà u l- effikaċja ta ’ terapija b’ MIRCERA f’ indikazzjonijiet oħra ma ġietx stabbilita.
Treatment of symptomatic anaemia in adult chronic kidney disease patients Treatment with MIRCERA has to be initiated under the supervision of a physician experienced in the management of patients with renal impairment.
Kura ta ’ anemija sintomatika f’ pazjenti adulti b’ mard kroniku tal- kliewi Kura b’ MIRCERA għandha tinbeda taħt is- sorveljanza ta ’ tabib b’ esperjenza fl- immaniġġjar ta ’ pazjenti b’ indeboliment renali.
Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician’ s evaluation of the individual patient’ s clinical course and condition is necessary.
Is- sintomi u r- riżultat ta ’ l- anemija jistgħu jvarjaw skond l- età, s- sess u l- effett globali tal- marda; valutazzjoni ta ’ tabib tal- progressjoni u l- kundizzjoni klinika tal- pazjent individwali hija neċessarja.
MIRCERA should be administered either subcutaneously or intravenously in order to increase haemoglobin to not greater than 12 g/ dl (7.45 mmol/ l).
MIRCERA għandha tingħata minn taħt il- ġilda jew minn ġol- vini sabiex iżżid l- emoglobina sa mhux aktar minn 12 g/ dl (7. 45 mmol/ l).
Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid puncture of peripheral veins.
Użu minn taħt il- ġilda huwa preferibbli f’ pazjenti li mhux qed jirċievu emodijalisi biex jiġi evitat it- titqib ta ’ vini periferali.
MIRCERA can be injected subcutaneously in the abdomen, arm or thigh.
MIRCERA tista ’ tiġi njettata taħt il- ġilda fl- addome, fid- dirgħajn jew fil- koxxa.
All three injection sites are equally suitable.
It- tliet postijiet huma adattati l- istess.
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
Minħabba varjabilità bejn il- pazjenti, xi kultant jistgħu jiġu osservati valuri ndividwali ta ’ l - emoglobina għall- pazjent aktar jew inqas mil- livell mixtieq.
Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/ dl (6.21 mmol/ l) to 12 g/ dl (7.45 mmol/ l).
Varjabilità ta ’ l- emoglobina għandha tiġi rranġata permezz ta ’ mmaniġġjar tad- doża, b’ kunsiderazzjoni għall- firxa mmirata ta ’ l- emoglobina ta ’ 10 g/ dl (6. 21 mmol/ l) sa 12 g/ dl (7. 45 mmol/ l).
A sustained haemoglobin level of greater than 12 g/ dl (7.45 mmol/ l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dl (7.45 mmol/ l) are observed are described below.
Livell sostnut ta ’ l- emoglobina ta ’ aktar minn 12 g/ dl (7. 45 mmol/ l) għandu jiġi evitat; gwida għall- aġġustament xieraq tad- doża għal meta jiġu osservati valuri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 45 mmol/ l) hija deskritta isfel.
A rise in haemoglobin of greater than 2 g/ dl (1.24 mmol/ l) over a four-week period should be avoided.
Żjieda fl- emoglobina ta ’ aktar minn 2 g/ dl (1. 24 mmol/ l) fuq perijodu ta ’ erba ’ ġimgħat għandha tiġi evitata.
If it occurs, appropriate dose adjustment should be made as provided.
Jekk dan iseħħ, aġġustament xieraq tad- doża għandu jsir kif ipprovdut.
2 Patients should be monitored closely to ensure that the lowest approved dose of MIRCERA is used to provide adequate control of the symptoms of anaemia.
2 Il- pazjenti għandhom jiġu ssorveljati mill- viċin sabiex jiġi assigurat li tiġi wżata l- inqas doża approvata ta ’ MIRCERA biex jiġi pprovdut kontroll adegwat tas- sintomi ta ’ l- anemija.
It is recommended that haemoglobin is monitored every two weeks until stabilized and periodically thereafter.
Huwa rrakkomandat li l- emoglobina tiġi ssorveljata kull ġimagħtejn sakemm tistabilizza u minn hemm ’ l quddiem perjodikament.
Patients not currently treated with an erythropoiesis stimulating agent (ESA):
Pazjenti li bħalissa mhux ikkurati b’ aġent li jistimula l- eritropoesi (ESA):
The recommended starting dose is 0.6 microgram/ kg body weight, administered once every two weeks as a single intravenous or subcutaneous injection in order to increase haemoglobin levels to greater than 10 g/ dl (6.21 mmol/ l).
Id- doża tal- bidu rrakkomandata hija ta ’ 0. 6 mikrogramma/ kg piż tal- ġisem, mogħtija darba kull ġimagħtejn bħala injezzjoni waħda ġol- vina jew taħt il- ġilda biex b’ hekk iżżid il- livelli ta ’ l - emoglobina għal aktar minn 10 g/ dl (6. 21 mmol/ l).
The dose may be increased by approximately 25% of the previous dose if the rate of rise in haemoglobin is less than 1.0 g/ dl (0.621 mmol/ l) over a month.
Id- doża tista ’ tiġi miżjuda b’ madwar 25% tad- doża ta ’ qabel jekk ir- rata taż- żjieda fl- emoglobina hija anqas minn 1. 0 g/ dl (0. 621 mmol/ l) fuq medda ta ’ xahar.
Further increases of approximately 25% may be made at monthly intervals until the individual target haemoglobin level is obtained.
Jistgħu jsiru aktar żidiet ta ’ madwar 25% f’ intervalli ta ’ xahar sakemm tintlaħaq il- mira ndividwali tal- livell ta ’ emoglobina.
If the rate of rise in haemoglobin is greater than 2 g/ dl (1.24 mmol/ l) in one month or if the haemoglobin level is increasing and approaching 12 g/ dl (7.45 mmol/ l), the dose is to be reduced by approximately 25%.
Jekk ir- rata taż- żjieda fl- emoglobina hija aktar minn 2 g/ dl (1. 24 mmol/ l) f’ xahar jew jekk il- livell ta ’ emoglobina qed jiżdied u joqrob għal 12 g/ dL (7. 45 mmol/ l), id- doża għandha titnaqqas b’ madwar 25%.
If the haemoglobin level continues to increase, therapy should be interrupted until the haemoglobin level begins to decrease, at which point therapy should be restarted at a dose approximately 25% below the previously administered dose.
Jekk il- livell ta ’ emoglobina jibqa ’ jiżdied, it- terapija għandha titwaqqaf sakemm il- livell ta ’ l - emoglobina jibda jonqos, fejn it- terapija għandha terġa ’ tinbeda b’ doża ta ’ madwar 25% inqas mid - doża li ngħatat qabel.
After dose interruption a haemoglobin decrease of approximately 0.35 g/ dl (0.22 mmol/ l) per week is expected.
Wara interruzzjoni tad- doża, huwa mistenni tnaqqis fl- emoglobina ta ’ madwar 0. 35 g/ dL (0. 22 mmol/ l) kull ġimgħa.
Dose adjustments should not be made more frequently than once a month.
Bidliet fid- doża m’ għandhomx isiru aktar frekwenti minn darba kull xahar.
If the haemoglobin concentration above 10 g/ dl (6.21 mmol/ l) is reached for the individual patient, MIRCERA may be administered once-monthly using the dose equal to twice the previous once-every– two-weeks dose.
Jekk tintlaħaq il- konċentrazzjoni ta ’ emoglobina ta ’ aktar minn 10 g/ dl (6. 21 mmol/ l) għall- pazjent individwali, MIRCERA tista ’ tingħata darba fix- xahar, bl- użu ta ’ doża ugwali għad- doppju tad- doża ta ’ qabel ta ’ darba kull ġimagħtejn.
Patients currently treated with an ESA:
Pazjenti li bħalissa qed jiġu kkurati b’ ESA:
Patients currently treated with an ESA can be switched to MIRCERA administered once a month as a single intravenous or subcutaneous injection.
Pazjenti li bħalissa qed jiġu kkurati b’ ESA jistgħu jinqalbu għal MIRCERA mogħtija darba fix- xahar bħala injezzjoni waħda fil- vina jew taħt il- ġilda.
The starting dose of methoxy polyethylene glycol- epoetin beta is based on the calculated previous weekly dose of darbepoetin alfa or epoetin at the time of substitution as described in Table 1.
Id- doża tal- bidu ta ’ methoxy polyethylene glycol - epoetin beta hija bbażata fuq id- doża kkalkulata ta ’ kull ġimgħa ta ’ qabel ta ’ darbepoetin alfa jew epoetin fil- ħin tas- sostituzzjoni kif deskritt f’ Tabella 1.
The first injection should start at the next scheduled dose of the previously administered darbepoetin alfa or epoetin.
L- ewwel injezzjoni għandha tinbeda mad- doża ta ’ wara skedata li jmiss ta ’ darbepoetin alfa jew epoetin li kien jingħata qabel.
MIRCERA starting doses
mogħtija ġol- vina jew
Previous weekly Previous weekly
il- ġilda
Monthly MIRCERA
ġilda
darb
taħt il- ġilda
epoetin alfa epoetin
(IU/ ġimgħa)
intravenous or
(mikrogramma/ darba
intravenous or intravenous or
(mikrogramma/ ġimgħa) < 40
subcutaneous dose
xahar) 120
If a dose adjustment is required to maintain the target haemoglobin concentration above 10 g/ dl (6.21 mmol/ l), the monthly dose may be increased by approximately 25%.
Jekk jinħtieġ tibdil fid- doża biex tinżamm il- mira ta ’ konċentrazzjoni ta ’ emoglobina ’ l fuq minn 10 g/ dl (6. 21 mmol/ l), id- doża ta ’ kull xahar tista ’ tiżdied b’ madwar 25%.
If the rate of rise in haemoglobin is greater than 2 g/ dl (1.24 mmol/ l) over a month or if the haemoglobin level is increasing and approaching 12 g/ dl (7.45 mmol/ l), the dose is to be reduced by approximately 25%.
3 Jekk ir- rata taż- żjieda fl- emoglobina hija ta ’ aktar minn 2 g/ dl (1. 24 mmol/ l) fuq medda ta ’ xahar jew jekk il- livell ta ’ emoglobina qed jiżdied u joqrob għal 12 g/ dL (7. 45 mmol/ l), id- doża għandha titnaqqas b’ madwar 25%.
If the haemoglobin level continues to increase, therapy should be interrupted until the haemoglobin level begins to decrease, at which point therapy should be restarted at a dose approximately 25% below the previously administered dose.
Jekk il- livell ta ’ emoglobina jibqa ’ jiżdied, it- terapija għandha titwaqqaf sakemm il- livell ta ’ l- emoglobina jibda jonqos, imbagħad it- terapija għandha terġa ’ tinbeda f’ doża ta ’ madwar 25% inqas mid- doża li ngħatat qabel.
After dose interruption a haemoglobin decrease of approximately 0.35 g/ dl (0.22 mmol/ l) per week is expected.
Wara interruzzjoni tad- doża, huwa mistenni tnaqqis fl - emoglobina ta ’ madwar 0. 35 g/ dL (0. 22 mmol/ l) kull ġimgħa.
3 Since the treatment experience is limited in patients on peritoneal dialysis, regular haemoglobin monitoring and strict adherence to dose adjustment guidance is recommended in these patients.
Minħabba li l- esperjenza bil- kura hija limitata f’ pazjenti b’ dijalisi peritonejali, sorveljanza regolari ta ’ l- emoglobina u twettiq bir- reqqa tal- linji gwida għall- aġġustament fid- doża huma rrakkomandati f’ dawn il- pazjenti.
Treatment interruption Treatment with MIRCERA is normally long-term.
Interruzzjoni tal- kura Kura b’ MIRCERA ġeneralment hija għal tul ta ’ żmien.
However, it can be interrupted at any time, if necessary.
Madankollu, tista ’ tiġi nterrotta f’ kull ħin, jekk hemm bżonn.
Missed dose If one dose of MIRCERA is missed, the missed dose is to be administered as soon as possible and administration of MIRCERA is to be restarted at the prescribed dosing frequency.
Meta tinsa tieħu doża Jekk tintesa doża waħda ta ’ MIRCERA, d- doża minsija trid tingħata malajr kemm jista ’ jkun, u l - għotja ta ’ MIRCERA għandha terġa ’ tinbeda bil- frekwenza ta ’ dożaġġ preskritt.
Paediatric use MIRCERA is not recommended for use in children and adolescents below 18 years due to a lack of safety and efficacy data.
Użu fit- tfal MIRCERA mhix irrakkomandata għall- użu fit- tfal u adoloxxenti taħt 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
Elderly patients In clinical studies 24% of patients treated with MIRCERA were aged 65 to 74 years, while 20% were aged 75 years and over.
Pazjenti anzjani Fi istudji kliniċi 24% tal- pazjenti kkurati b’ MIRCERA kellhom età ta ’ 65 sa 74 sena, waqt li 20% kellhom età ta ’ 75 sena jew aktar.
No dose adjustment is required in patients aged 65 years or older.
M’ hemmx bżonn ta ’ aġġustament fid- doża f’ pazjenti b’ età ta ’ 65 sena jew aktar.
Patients with hepatic impairment No adjustments of the starting dose nor of the dose modification rules are required in patients with hepatic impairment (see section 5.2).
Pazjenti b’ indeboliment tal- fwied L- ebda aġġustament tad- doża tal- bidu jew tar- regoli tal- modifikazzjoni tad- doża ma huma meħtieġa f’ pazjenti b’ indeboliment tal- fwied (ara sezzjoni 5. 2).
Uncontrolled hypertension
Pressjoni għolja mhix ikkontrollata.
Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 microgram/ l or with transferrin saturation below 20%.
Terapija supplimentari ta ’ ħadid hija rrakkomandata għall- pazjenti kollha b’ valuri ta ’ ferritin fis- serum taħt 100 mikrogramma/ l jew b’ saturazzjoni ta ’ transferrin taħt 20%.
To ensure effective erythropoiesis, iron status has to be evaluated for all patients prior to and during treatment.
Biex tkun żgurata eritropoesi effettiva, l- istat tal- ħadid fid- demm għandu jkun evalwat fil- pazjenti kollha, qabel u waqt il- kura.
Failure to respond to MIRCERA therapy should prompt for a search for causative factors.
Falliment ta ’ rispons għall- kura b’ MIRCERA għandu jġiegħel tfittxija għall- fatturi ta ’ kawża.
Deficiencies of iron, folic acid or vitamin B12 reduce the effectiveness of ESAs and should therefore be corrected.
Defiċjenzi ta ’ ħadid, folic acid jew vitamina B12 inaqqasu l- effettività ta ’ ESAs u għalhekk għandhom jiġu kkoreġuti.
Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, severe aluminium toxicity, underlying haematologic diseases, or bone marrow fibrosis may also compromise the erythropoietic response.
Infezzjonijiet fl- istess waqt, episodji ta ’ infjammazzjoni jew trawmatiċi, telf ta ’ demm okkult, emolisi, tossiċità ta ’ l- aluminju severa, preżenza ta ’ mard ematoloġiku fl- istess ħin, jew fibrożi tal- mudullun ukoll jistgħu jikkompromettu r- rispons eritropoetiku.
A reticulocyte count should be considered as part of the evaluation.
L- għadd ta ’ retikuloċiti għandu jiġi kkunsidrat bħala parti mill- evalwazzjoni.
If all the conditions mentioned are excluded and the patient has a sudden drop of haemoglobin associated with reticulocytopenia and anti-erythropoietin antibodies, examination of the bone marrow for the diagnosis of Pure Red Cell Aplasia (PRCA) should be considered.
Jekk il- kundizzjonijiet imsemmija kollha huma esklużi u l - pazjent ikollu nuqqas f’ daqqa ta ’ emoglobina assoċjat ma ’ retikulocitopenija u antikorpi anti - eritropoetin, għandha tiġi kkunsidrata eżaminazzjoni tal- mudullun ta ’ l- għadam għad- dijanjosi ta ’ Aplasija Pura taċ- Ċelluli l- Ħomor (PRCA).
In case PRCA is diagnosed, therapy with MIRCERA must be discontinued and patients should not be switched to another ESA.
F’ każ li tiġi dijanjosata PRCA, terapija b’ MIRCERA għandha titwaqqaf, u l- pazjenti m’ għandhomx jinqalbu għall- ESA ieħor.
Pure Red Cell Aplasia caused by anti-erythropoietin antibodies has been reported in association with ESAs.
4 Aplasija Pura taċ- Ċelluli l- Ħomor ikkawżata minn antikorpi anti- eritropoetin, kienet irrappurtata f’ assoċjazzjoni ma ’ ESAs.
These antibodies have been shown to cross-react with all ESAs, and patients suspected or confirmed to have antibodies to erythropoietin should not be switched to MIRCERA.
Dawn l- antikorpi ntwerew li jirreaġixxu ma ’ l- ESAs kollha, u pazjenti ssuspettati jew ikkonfermati li għandhom antikorpi għal eritropoetin m’ għandhomx jinqalbu fuq MIRCERA.
Haemoglobin concentration:
Konċentrazzjoni ta ’ l- emoglobina:
In patients with chronic kidney disease, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
F’ pazjenti b’ marda kronika tal- kliewi, l- konċentrazzjoni ta ’ l - emoglobina miżmuma m’ għandhiex taqbeż il- limitu ta ’ fuq tal- konċentrazzjoni mmirata ta ’ l - emoglobina rrakkomandata f’ sezzjoni 4. 2.
In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12g/ dl (7.5 mmol/ l).
Fi provi kliniċi, kienet osservata żjieda fir- riskju ta ’ mewt u ta ’ avvenimenti kardjovaskulari serji meta sustanzi li jistimolaw l- eritropoesi (ESAs) ingħataw biex tintlaħaq emoglobina ta ’ aktar minn 12 g/ dl (7. 5 mmol/ l).
Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Provi kliniċi kkontrollati ma wrewx benefiċċji sinifikanti attribwiti lill- għoti ta ’ epoetins meta l - konċentrazzjoni ta ’ l- emoglobina tiżdied ’ l fuq mil- livell neċessarju għall- kontroll ta ’ sintomi ta ’ l - anemija u biex tiġi evitata trasfużjoni tad- demm.
4 Blood pressure monitoring:
Sorveljanza tal- pressjoni tad- demm:
As with other ESAs, blood pressure may rise during treatment with MIRCERA.
Bħal f’ ESAs oħra, il- pressjoni tad- demm tista ’ tiżdied waqt kura b’ MIRCERA.
Blood pressure should be adequately controlled in all patients before, at initiation of, and during treatment with MIRCERA.
Il- pressjoni tad- demm għandha tkun ikkontrollata b’ mod adegwat fil- pazjenti kollha qabel, fil- bidu, u waqt il- kura b’ MIRCERA.
If high blood pressure is difficult to control by medical treatment or dietary measures, the dose must be reduced or administration discontinued (see section 4.2).
Jekk huwa diffiċli biex tikkontrolla l- pressjoni għolja tad - demm b’ kura b’ mediċini jew b’ miżuri ta ’ dieta, d- doża għandha titnaqqas jew l- għoti għandu jitwaqqaf (ara sezzjoni 4. 2).
Effect on tumour growth:
Effett fuq it- tkabbir tat- tumur:
MIRCERA, like other ESAs, is a growth factor that primarily stimulates red blood cell production.
MIRCERA, bħal ESAs oħra, hija fattur tat- tkabbir li tistimula primarjament il- produzzjoni ta ’ ċelluli ħomor tad- demm.
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Riċetturi għal eritropoetin jistgħu jinstabu fuq il- wiċċ ta ’ varjetà ta ’ ċelluli tat- tumur.
As with all growth factors, there is a concern that ESAs could stimulate the growth of any type of malignancy.
Bħal b’ fatturi tat- tkabbir oħra, hemm il- biża ’ li ESAs jistgħu jistimulaw it - tkabbir ta ’ kull tip ta ’ tumur malinn.
Two controlled clinical studies in which epoetins were administered to patients with various cancers including head and neck cancers, and breast cancer, have shown an unexplained excess mortality.
Żewġ studji kliniċi kkontrollati fejn epoetins ġew amministrati lill - pazjenti b’ diversi kanċers, inkluż kanċers fir- ras u fl - għonq, u kanċer tas- sider, urew żjieda mhux spjegata ta ’ mortalità.
MIRCERA is not approved for the treatment of anaemia in patients with cancer.
MIRCERA mhix approvata għall- kura ta ’ anemija f’ pazjenti bil- kanċer.