qanastek/EMEA-V3 huggingface dataset:
MIRCERA 600 micrograms/0.6 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
MIRCERA 600 mikrogramma/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest methoxy polyethylene glycol epoetin beta
1 pre-filled syringe contains 600 micrograms of methoxy polyethylene glycol-epoetin beta.
Siringa waħda mimlija għal- lest fiha 600 mikrogramma ta ’ methoxy polyethylene glycol epoetin beta.
217 10.
242 10.
218 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
243 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
600 micrograms PRE-FILLED SYRINGES LABEL
TIKKETTA TAS- SIRINGI MIMLIJA GĦAL- LEST ta ’ 600 mikrogramma
MIRCERA 600 µg/0.6 ml injection methoxy polyethylene glycol-epoetin beta SC/IV
MIRCERA 600 µg/ 0. 6 ml injezzjoni methoxy polyethylene glycol- epoetin beta SC/ IV
219 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
244 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON 800 micrograms PRE-FILLED SYRINGE
KARTUNA TA ’ BARRA – SIRINGA MIMLIJA GĦAL- LEST ta ’ 800 mikrogramma
MIRCERA 800 micrograms/0.6 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
MIRCERA 800 mikrogramma/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest methoxy polyethylene glycol epoetin beta
1 pre-filled syringe contains 800 micrograms of methoxy polyethylene glycol-epoetin beta.
Siringa waħda mimlija għal- lest fiha 800 mikrogramma ta ’ methoxy polyethylene glycol epoetin beta.
220 10.
245 10.
221 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
246 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
800 micrograms PRE-FILLED SYRINGES LABEL
TIKKETTA TAS- SIRINGI MIMLIJA GĦAL- LEST ta ’ 800 mikrogramma
MIRCERA 800 µg/0.6 ml injection methoxy polyethylene glycol-epoetin beta SC/IV
MIRCERA 800 µg/ 0. 6 ml injezzjoni methoxy polyethylene glycol- epoetin beta SC/ IV
222 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
247 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON 30 micrograms PRE-FILLED SYRINGE
KARTUNA TA ’ BARRA – SIRINGA MIMLIJA GĦAL- LEST ta ’ 30 mikrogramma
MIRCERA 30 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
MIRCERA 30 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest methoxy polyethylene glycol epoetin beta
1 pre-filled syringe contains 30 micrograms of methoxy polyethylene glycol-epoetin beta.
Siringa waħda mimlija għal- lest fiha 30 mikrogramma ta ’ methoxy polyethylene glycol epoetin beta.
223 10.
248 10.
224 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
249 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
30 micrograms PRE-FILLED SYRINGES LABEL
TIKKETTA TAS- SIRINGI MIMLIJA GĦAL- LEST ta ’ 30 mikrogramma
MIRCERA 30 µg/0.3 ml injection methoxy polyethylene glycol-epoetin beta SC/IV
MIRCERA 30 µg/ 0. 3 ml injezzjoni methoxy polyethylene glycol- epoetin beta SC/ IV
225 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
250 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON 40 micrograms PRE-FILLED SYRINGE
KARTUNA TA ’ BARRA – SIRINGA MIMLIJA GĦAL- LEST ta ’ 40 mikrogramma
MIRCERA 40 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
MIRCERA 40 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest methoxy polyethylene glycol epoetin beta
1 pre-filled syringe contains 40 micrograms of methoxy polyethylene glycol-epoetin beta.
Siringa waħda mimlija għal- lest fiha 40 mikrogramma ta ’ methoxy polyethylene glycol epoetin beta.
226 10.
251 10.
227 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
252 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
40 micrograms PRE-FILLED SYRINGES LABEL
TIKKETTA TAS- SIRINGI MIMLIJA GĦAL- LEST ta ’ 40 mikrogramma
MIRCERA 40 µg/0.3 ml injection methoxy polyethylene glycol-epoetin beta SC/IV
MIRCERA 40 µg/ 0. 3 ml injezzjoni methoxy polyethylene glycol- epoetin beta SC/ IV
228 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
253 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON 60 micrograms PRE-FILLED SYRINGE
KARTUNA TA ’ BARRA – SIRINGA MIMLIJA GĦAL- LEST ta ’ 60 mikrogramma
MIRCERA 60 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
MIRCERA 60 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest methoxy polyethylene glycol epoetin beta
1 pre-filled syringe contains 60 micrograms of methoxy polyethylene glycol-epoetin beta.
Siringa waħda mimlija għal- lest fiha 60 mikrogramma ta ’ methoxy polyethylene glycol epoetin beta.
229 10.
254 10.
230 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
255 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
60 micrograms PRE-FILLED SYRINGES LABEL
TIKKETTA TAS- SIRINGI MIMLIJA GĦAL- LEST ta ’ 60 mikrogramma
MIRCERA 60 µg/0.3 ml injection methoxy polyethylene glycol-epoetin beta SC/IV
MIRCERA 60 µg/ 0. 3 ml injezzjoni methoxy polyethylene glycol- epoetin beta SC/ IV
231 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
256 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON 120 micrograms PRE-FILLED SYRINGE
KARTUNA TA ’ BARRA – SIRINGA MIMLIJA GĦAL- LEST ta ’ 120 mikrogramma
MIRCERA 120 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
MIRCERA 120 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest methoxy polyethylene glycol epoetin beta
1 pre-filled syringe contains 120 micrograms of methoxy polyethylene glycol-epoetin beta.
Siringa waħda mimlija għal- lest fiha 120 mikrogramma ta ’ methoxy polyethylene glycol epoetin beta.
232 10.
257 10.
233 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
258 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
120 micrograms PRE-FILLED SYRINGES LABEL
TIKKETTA TAS- SIRINGI MIMLIJA GĦAL- LEST ta ’ 120 mikrogramma
MIRCERA 120 µg/0.3 ml injection methoxy polyethylene glycol-epoetin beta SC/IV
MIRCERA 120 µg/ 0. 3 ml injezzjoni methoxy polyethylene glycol- epoetin beta SC/ IV
234 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
259 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON 360 micrograms PRE-FILLED SYRINGE
KARTUNA TA ’ BARRA – SIRINGA MIMLIJA GĦAL- LEST ta ’ 360 mikrogramma
MIRCERA 360 micrograms/0.6 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
MIRCERA 360 mikrogramma/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest methoxy polyethylene glycol epoetin beta
1 pre-filled syringe contains 360 micrograms of methoxy polyethylene glycol-epoetin beta.
Siringa waħda mimlija għal- lest fiha 360 mikrogramma ta ’ methoxy polyethylene glycol epoetin beta.
235 10.
260 10.
236 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
261 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
360 micrograms PRE-FILLED SYRINGES LABEL
TIKKETTA TAS- SIRINGI MIMLIJA GĦAL- LEST ta ’ 360 mikrogramma
MIRCERA 360 µg/0.6 ml injection methoxy polyethylene glycol-epoetin beta SC/IV
MIRCERA 360 µg/ 0. 6 ml injezzjoni methoxy polyethylene glycol- epoetin beta SC/ IV
237 B.
262 B.
238 PACKAGE LEAFLET:
263 FULJETT TA ’ TAGĦRIF:
MIRCERA 50 micrograms/ml solution for injection 100 micrograms/ml solution for injection 200 micrograms/ml solution for injection 300 micrograms/ml solution for injection 400 micrograms/ml solution for injection 600 micrograms/ml solution for injection 1000 micrograms/ml solution for injection
MIRCERA 50 mikrogramma/ ml soluzzjoni għall- injezzjoni 100 mikrogramma/ ml soluzzjoni għall- injezzjoni 200 mikrogramma/ ml soluzzjoni għall- injezzjoni 300 mikrogramma/ ml soluzzjoni għall- injezzjoni 400 mikrogramma/ ml soluzzjoni għall- injezzjoni 600 mikrogramma/ ml soluzzjoni għall- injezzjoni 1000 mikrogramma/ ml soluzzjoni għall- injezzjoni
1.
X’ inhu MIRCERA u għalxiex jintuża 1.
Before you use MIRCERA 3.
Qabel ma tuża MIRCERA 3.
How to use MIRCERA 4.
Kif għandek tuża MIRCERA 4.
How to store MIRCERA 6.
Kif taħżen MIRCERA 6.
WHAT MIRCERA IS AND WHAT IT IS USED FOR
X’ INHU MIRCERA U GĦALXIEX JINTUŻA
This medicine is prescribed to you because you have anaemia caused by your chronic kidney disease and associated with typical symptoms such as tiredness, weakness and shortness of breath.
Din il- mediċina ġiet preskritta lilek minħabba li għandek anemija kkawżata mill- marda kronika tal - kliewi u assoċjata ma ’ sintomi tipiċi bħal għeja, dgħjufija u qtugħ ta ’ nifs.
This means that you have too few red blood cells and your haemoglobin level is too low (your body’s tissues might not receive enough oxygen)..
Dan ifisser li int għandek ftit wisq elluliċelluli ħomor tad- demm u l- livell ta ’ l- emoglobina tiegħek huwa baxx wisq (it- tessuti ta ’ ġismek jistgħu ma jkunux qed jirċievu biżżejjed ossiġnu).
MIRCERA is used to treat only the symptomatic anaemia caused by your chronic kidney disease.
MIRCERA jintuża biex jikkura l- anemija sintomatika kkawżata mill- marda kronika tal- kliewi biss.
It has not been shown that MIRCERA can be used to treat anaemia caused by other diseases.
Ma ntweriex li MIRCERA jista ’ jintuża biex jikkura anemija kkawżata minn mard ieħor.
MIRCERA is a medicine produced by gene-technology.
MIRCERA hija mediċina prodotta minn teknoloġija tal- geni.
Like the natural hormone erythropoietin, MIRCERA increases the number of red blood cells and haemoglobin level in your blood.
Bħall- ormon naturali eritropoetin, MIRCERA jżid in- numru ta ’ ċelluli ħomor tad- demm u jżid il- livell ta ’ l- emoglobina fid- demm tiegħek.
Compared to other medicines of the same class called erythropoiesis stimulating agents (or ESA), MIRCERA can stay in your body longer, therefore fewer injections are required for your treatment.
Ikkomparat ma ’ mediċini oħrajn ta ’ l- istess klassi msejħa aġenti li jistimolaw l- eritropoesi (jew ESA), MIRCERA jista ’ jdum aktar f’ ġismek, għalhekk ikun hemm bżonn ta ’ inqas injezzjonijiet għall- kura tiegħek.
2.
264 2.
BEFORE YOU USE MIRCERA
QABEL MA TUŻA MIRCERA
Do not use MIRCERA
Tużax MIRCERA
- if you are allergic (hypersensitive) to methoxy polyethylene glycol-epoetin beta or to any of the
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal methoxy polyethylene glycol- epoetin
other ingredients of MIRCERA (see section 6)
beta jew sustanzi oħra ta ’ MIRCERA (ara sezzjoni 6)
- if you have high blood pressure that cannot be controlled
- jekk għandek pressjoni għolja tad- demm li ma tistax tiġi kkontrollata
239 Take special care with MIRCERA
Oqgħod attent ħafna b’ MIRCERA
MIRCERA is indicated to treat only the symptomatic anaemia caused by chronic kidney disease.
MIRCERA huwa ndikat biex jikkura l- anemija sintomatika kkawżata minn marda kronika tal- kliewi biss.
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 ġewx stabbiliti.
Before treatment with MIRCERA
Qabel kura b’ MIRCERA
- A condition called Pure Red Cell Aplasia (stopped or reduced production of red blood cells) due
imnaqqsa taċ- ċelluli ħomor tad- demm) minħabba li kienu osservati antikorpi anti- eritropoetin f’ uħud mill- pazjenti kkurati b’ ESAs oħra.
to anti-erythropoietin antibodies was observed in some patients treated with other ESAs. – If your doctor suspects or confirms that you have these antibodies in your blood you must not be treated with MIRCERA.
- Jekk it- tabib tiegħek jissuspetta jew jikkonferma li inti għandek dawn l- antikorpi fid- demm
- If you are a cancer patient be aware that MIRCERA, like other ESAs may act as a growth
- Jekk inti pazjent li għandek il- kanċer għandek tkun taf li MIRCERA, bħal ESAs oħra jista ’
factor.
jaħdem bħala fattur tat- tkabbir.
- It is not known if MIRCERA has a different effect in patients with haemoglobinopathies
- Mhux magħruf jekk MIRCERA għandux effett differenti f’ pazjenti b’ emoglobinopatiji (mard
(disorders associated with abnormal haemoglobin), past or present bleeding, seizures or with a high blood platelet count.
assoċjat ma ’ emoglobina anormali), fsada preżenti jew fil- passat, aċċessjoni jew b’ għadd ta ’ plejtlets fid- demm għoli.
If you have any of these conditions your doctor will discuss it with you and must treat you with caution.
Jekk għandek xi waħda minn dawn il- kundizzjonijiet, it- tabib tiegħek jiddiskuti dan miegħek u għandu jikkurak b’ kawtela.
- Healthy people should not use MIRCERA.
- Persuni b’ saħħithom m’ għandhomx jużaw MIRCERA.
Using it can lead to too high haemoglobin levels and
Jekk din tintuża tista ’ twassal għal -
cause problems with the heart or blood vessels that may be life-threatening.
livelli ta ’ emoglobina għolja wisq u tikkawża problemi fil- qalb u fil- kanali tad- demm li jistgħu jkunu ta ’ periklu ghall- ħajja.
During treatment with MIRCERA
Waqt kura b’ MIRCERA
- Your doctor may initiate treatment with MIRCERA if your haemoglobin level is 10 g/dl (6.21
- It- tabib tiegħek jista 'jibda kura b’ MIRCERA jekk il- livell ta ’ l- emoglobina tiegħek huwa 10
mmol/l) or less.
g/ dl (6. 21 mmol/ l) jew inqas.
After initiation of therapy, your doctor will seek to maintain your haemoglobin level between 10 and 12 g/dl (7.45 mmol/l). – Your doctor will check the amount of iron in your blood before and during MIRCERA treatment.
- It- tabib tiegħek jiċċekkja l- kwantità ta ’ ħadid fid- demm tiegħek qabel u waqt il- kura b ’
If the amount is too low your doctor may give you an additional iron supplement.
Jekk il- kwantità hija baxxa wisq it- tabib tiegħek jista ’ jtik mediċina li fiha l- ħadid.
If
- It- tabib tiegħek jiċċekkja l- pressjoni tad- demm tiegħek qabel u waqt il- kura tiegħek b ’
your blood pressure is high and cannot be controlled either by appropriate medicines or a special diet, your doctor will interrupt your MIRCERA treatment or reduce the dose.
Jekk il- pressjoni tad- demm tiegħek hija għolja u ma tistax tiġi kkontrollata la b’ mediċini xierqa u lanqas b’ dieta speċjali, it- tabib tiegħek iwaqqaf il- kura tiegħek b’ MIRCERA jew inaqqas id- doża.
- Your doctor will check that your haemoglobin does not exceed a certain level, as high
- It- tabib tiegħek se jiċċekkja li l- emoglobina tiegħek ma tkunx aktar minn ċertu livell peress li
haemoglobin could put you at risk of having a problem of the heart or the blood vessels and could increase risk of death.
emoglobina għolja tista ’ tpoġġik f’ riskju li jkollok problema tal- qalb jew tal- vini/ arterji tad - demm u tista ’ żżid ir- riskju ta ’ mewt.
- Contact your doctor if you feel tired, weak or have shortness of breath as this could mean that
- Kellem lit- tabib tiegħek jekk tħossok għajjien, dgħajjef jew jekk ikollok qtugħ ta ’ nifs minħabba
your MIRCERA treatment is not effective.
li dan jista ’ jfisser li l- kura tiegħek b’ MIRCERA mhix effettiva.
Your doctor will check that you do not have other causes of anaemia and may perform blood tests or examine your bone marrow.
It- tabib tiegħek jiċċekkja li int m’ għandekx kawżi oħra ta ’ l- anemija u jista ’ jagħmel testijiet tad- demm jew jeżamina il - mudullun.
If you have developed Pure Red Cell Aplasia your MIRCERA treatment will be discontinued.
Jekk żviluppajt Aplasija Pura taċ- Ċelluli l- Ħomor il- kura tiegħek b’ MIRCERA titwaqqaf.
You will not receive another ESA and your doctor will treat you for this condition.
Int ma tingħatax ESA ieħor u t- tabib tiegħek jikkurak għal din il- kundizzjoni.
Children and adolescents Treatment with MIRCERA is not recommended in children and adolescents as it has not been studied in these patients.
Tfal u adoloxxenti Kura b’ MIRCERA mhix irrakkomandata fit- tfal u adoloxxenti minħabba li ma ġietx studjata f’ dawn il- pazjenti.
Using other medicines Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
No interaction studies have been performed.
Ma sarux studji ta ’ interazzjoni.
There is no evidence that MIRCERA interacts with other medicines.
M’ hemmx evidenza li MIRCERA tinteraġixxi ma ’ mediċini oħra.
Using MIRCERA with food and drink Food and drink do not affect MIRCERA.
265 Meta tuża MIRCERA ma ’ l- ikel u max- xorb Ikel u xorb ma affettwax lil MIRCERA.
MIRCERA has not been studied in pregnant or breast-feeding women.
MIRCERA ma ġietx studjata f’ nisa tqal jew li qed ireddgħu.
Tell your doctor if you are pregnant, think you are pregnant or intend to become pregnant.
Għid lit- tabib tiegħek jekk inti tqila, taħseb li inti tqila jew tixtieq toħroġ tqila.
Your doctor will consider what is the best treatment for you during pregnancy.
It- tabib tiegħek jikkunsidra x’ inhu l- aħjar kura għalik waqt it- tqala.
Tell your doctor if you are breast-feeding or intend to breast-feed.
Għid lit- tabib tiegħek jekk qed tredda ’ jew tixtieq tredda ’.
Your doctor will advise if you should stop or continue breast-feeding and stop or continue your treatment.
It- tabib tiegħek jgħidlek jekk għandekx tkompli jew twaqqaf t- treddigħ, jew tkompli jew twaqqaf l- kura tiegħek b’ MIRCERA.
240 Driving and using machines MIRCERA does not affect your ability to drive and use machines.
Sewqan u tħaddim ta ’ magni MIRCERA ma taffettwax l- ħila tiegħek biex issuq u tħaddem magni.
Important information about some of the ingredients of MIRCERA This medicine contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially ‘sodium-free’.
Tagħrif importanti dwar uħud mis- sustanzi ta ’ MIRCERA Din il- mediċina fiha inqas minn 1 mmol ta ’ sodju (23 mg) kull ml, i. e. essenzjalment ‘ bla sodju ’.
HOW TO USE MIRCERA
KIF GĦANDEK TUŻA MIRCERA
Always use MIRCERA exactly as your doctor has told you.
Dejjem għandek tuża MIRCERA skond il- parir eżatt tat- tabib.
Treatment with MIRCERA must be started under the supervision of a healthcare professional.
Kura b’ MIRCERA għandha tinbeda taħt is- superviżjoni ta ’ professjonist fil- qasam mediku.
Further injections can be given by a healthcare professional or, after you have been trained, you can inject MIRCERA yourself (see instructions at the end of this leaflet.)
Injezzjonijiet ta ’ wara jistgħu jingħataw minn professjonist fil- qasam tas- saħħa jew, wara li tkun ġejt imħarreġ, inti tista ’ tinjetta MIRCERA lilek innifsek (ara l- istruzzjonijiet fl- aħhar ta ’ dan il- fuljett.)
MIRCERA can be injected under the skin in the abdomen, arm or thigh; or into a vein.
MIRCERA jista ’ jiġi njettat taħt il- ġilda fl- addome, fid- dirgħajn jew fil- koxxa; jew ġo vina.
Your doctor will decide which is best for you.
It- tabib tiegħek jiddeċidi liema post hu l- aħjar għalik.
Your doctor will carry out regular blood tests to monitor how your anaemia is responding to treatment by measuring your haemoglobin level.
It- tabib tiegħek jagħmel testijiet tad- demm regolari biex jissorvelja kif l- anemija tiegħek qed tirrispondi għall- kura billi jkejjel il- livell ta ’ emoglobina tiegħek.
- If you are not currently treated with an ESA
- Jekk bħalisssa mhux qed tiġi kkurat b’ ESA
The recommended starting dose of MIRCERA is 0.6 micrograms for every kilogram of your body weight.
Id- doża tal- bidu rrakkomandata ta ’ MIRCERA hija ta ’ 0. 6 mikrogramma kull kilogramm ta ’ piż tal - ġisem tiegħek.
The dose is to be administered once every 2 weeks as a single injection.
Id- doża għandha tingħata darba kull ġimgħatejn bħala injezzjoni waħda.
Your doctor may increase or decrease your dose or temporarily stop your treatment to adjust your haemoglobin level, as appropriate for you.
It- tabib tiegħek jista ’ jżid jew inaqqas id- doża tiegħek jew iwaqqaf il- kura temporanjament biex jaġġusta il- livell ta ’ emoglobina tiegħek, kif xieraq għalik.
Dose changes will not be made more often than once a month.
Bidliet fi- doża mhux se jsiru aktar ta ’ spiss minn darba fix- xahar.
Once your anaemia is corrected your doctor may change your dosing to once a month administration.
Ladarba l- anemija tiegħek tiġi kkoreġuta it- tabib tiegħek jista ’ jbiddillek id- dożaġġ għall- għotja ta ’ darba fix- xahar.
- If you are currently being treated with another ESA
- Jekk bħalissa qed tiġi kkurat b’ ESA ieħor
Your doctor may replace your current medicine with MIRCERA.
It- tabib tiegħek jista ’ jibdillek il- mediċina tiegħek li qed tieħu bħalissa għal MIRCERA.
Your doctor will decide to treat you with MIRCERA administered as a single injection once a month.
It- tabib tiegħek jiddeċiedi jekk jikkurakx b’ MIRCERA amministrata bħala injezzjoni darba fix- xahar.
Your doctor will calculate your MIRCERA starting dose based on the last dose of your previous medicine.
It- tabib tiegħek jikkalkola d- doża tal- bidu tiegħek ta ’ MIRCERA ibbażat fuq l- aħħar doża tal- mediċina tiegħek ta ’ qabel.
The first MIRCERA dose will be given on the planned injection day of your previous medicine.
L- ewwel doża ta ’ MIRCERA tingħata fil- ġurnata ppjanata għal l- injezzjoni tal- mediċina tiegħek ta ’ qabel.
Your doctor may increase or decrease your dose or temporarily stop your treatment to adjust your haemoglobin to an appropriate level for you.
It- tabib tiegħek jista ’ jżid jew inaqqas id- doża jew iwaqqaf temporanjament il- kura tiegħek biex jaġġusta l- emoglobina tiegħek sa livell xieraq għalik.
Dose changes will not be made more often than once a month.
Bidliet fid- doża mhux se jsiru aktar ta ’ spiss minn darba fix- xahar.
If you use more MIRCERA than you should Please contact your doctor or pharmacist if you used too large a dose of MIRCERA as it may be necessary to perform some blood tests and interrupt your treatment.
266 Jekk tuża MIRCERA aktar milli suppost Jekk jogħġbok kellem lit- tabib jew lill- ispiżjar tiegħek jekk użajt doża kbira wisq ta ’ MIRCERA minħabba li jista ’ jkun hemm bżonn li jsiru xi testijiet tad- demm u li titwaqqaf temporanjament il- kura tiegħek.
If you forget to use MIRCERA If you miss a dose of MIRCERA administer the missed dose as soon as you remember and talk to your doctor about when to use the next doses.
Jekk tinsa tuża MIRCERA Jekk tinsa doża ta ’ MIRCERA ħudha hekk kif tiftakar u kellem lit- tabib tiegħek dwar meta tieħu d - dożi li jmiss.
If you stop using MIRCERA Treatment with MIRCERA is normally long-term.
Jekk tieqaf tuża MIRCERA Kura b’ MIRCERA normalment hija fit- tul.
It can, however, be stopped on the advice of your doctor at any time.
Madankollu jista ’ jitwaqqaf f’ kull waqt fuq parir tat- tabib tiegħek..
Like all medicines, MIRCERA can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, MIRCERA jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10); common (affects 1 to 10 users in 100); uncommon (affects 1 to 10 users in 1’000); rare (affects 1 to 10 users in 10’000); very rare (affects less than 1 user in 10’000); not known (frequency cannot be estimated from the available data).
Il- frekwenza ta ’ l- effetti sekondarji possibli elenkati taħt hija definita bl- użu tal- konvenzjoni li ġejja: komuni ħafna (jaffettwaw aktar minn persuna waħda li qed tużah minn kull 10); komuni (jaffettwaw minn persuna 1 sa 10 li qed jużawh minn kull 100); mhux komuni (jaffettwaw minn persuna 1 sa 10 li qed jużawh minn kull 1’ 000); rari (jaffettwaw minn persuna 1 sa 10 li qed jużawh minn kull 10’ 000); rari ħafna (jaffettwaw inqas minn persuna 1 li qed tużah minn kull 10’ 000); mhux magħruf (il - frekwenza ma tistax tiġi stmata mit- tagħrif disponibbli).
A common side effect is hypertension (high blood pressure).
Effett sekondarju komuni hija ipertensjoni (pressjoni għolja tad- demm).
Uncommon side effects are:
Effetti sekondarji mhux komuni huma:
- vascular access thrombosis (blood clots in your dialysis access).
- trombożi ta ’ aċċess vaskulari (biċċiet ta ’ demm magħqud fl- aċċess għad- dijalisi tiegħek)
Rare side effects are:
Effetti sekondarji rari huma:
- hypertensive encephalopathy (very high blood pressure that can result in headache, especially
- enċefalopatija ipertensiva (pressjoni tad- demm għolja ħafna li tista ’ twassal għall- uġigħ ta ’ ras,
sudden, stabbing, migraine -like headache, confusion, speech disturbances, fits or convulsions).
speċjalment uġigħ ta ’ ras bħall- emikranja li jitfaċċa f’ daqqa u jtektek, konfużjoni, disturbi fid - diskors, aċċessjonijiet jew konvulżjonijiet).
If you have these symptoms please contact your doctor immediately to receive treatment.
Jekk għandek dawn is- sintomi, jekk jogħġbok kellem lit- tabib tiegħek minnufiħ biex tingħata kura.
- maculo-papular rash (red skin reaction that can include pimples or spots)
- raxx makulo- papulari (reazzjoni fil- ġilda bi ħmura li tista ’ tinkludi ponot jew insiemer)
- hot flush
- fwawar
- hypersensitivity (allergic reaction that can cause unusual wheezing or difficulty in breathing;
- sensittività eċċessiva (reazzjoni allerġika li tista ’ tikkawża tisfir mhux tas- soltu jew diffikultà
swollen tongue, face or throat, or swelling around the injection site, or make you feel light- headed, faint or cause you to collapse).
biex tieħu n- nifs; nefħa fl- ilsien, wiċċ jew griżmejn, jew nefħa madwar il- post ta ’ l- injezzjoni, jew iġġiegħlek tħossok sturdut, iħossok ħass ħażin jew tikkollassa.
If you have these symptoms please contact your doctor immediately to receive treatment.
Jekk għandek dawn is - sintomi jekk jogħġbok kellem lit- tabib tiegħek minnufih biex tingħata kura.
During clinical studies patients had a slight decrease in their platelet blood counts.
Waqt l- istudji kliniċi l- pazjenti kellhom tnaqqis żgħir fl- għadd tal- plejtlets fid- demm.
Some patients had platelet counts below the normal range.
Xi pazjenti kellhom għadd ta ’ plejtlets taħt il- firxa normali.
HOW TO STORE MIRCERA
KIF TAĦŻEN MIRCERA
Do not use MIRCERA after the expiry date which is stated on the outer carton and vial label after ‘EXP’.
Tużax MIRCERA wara d- data ta ’ skadenza li tidher fuq il- kartuna ta ’ barra u fuq it- tikketta tal- kunjett wara ‘ JIS ’.
Keep the vial in the outer carton in order to protect from light.
Żomm il- kunjett fil- kartuna ta ’ barra sabiex tilqa mid- dawl.
You may remove MIRCERA from the refrigerator and store it at a room temperature not above 25 °C for a period of one month.
Tista ’ tneħħi MIRCERA mill- friġġ u taħżnu f’ temperatura tal- kamra mhux ’ l fuq minn 25°C għall - perijodu wieħed ta ’ xahar.
During this period when you have stored MIRCERA at a room temperature not above 25 °C you may not put MIRCERA back in the refrigerator before use.
F’ dan il- perijodu fejn MIRCERA kien maħżun f’ temperatura tal- kamra mhux ’ l fuq minn 25°C tista ’ terġa tpoġġi lil MIRCERA fil- friġġ qabel l- użu.
Once you have removed your medicine from the refrigerator you must use it within this period of one month.
Ladarba neħħejt il - mediċina tiegħek mill- friġġ trid tużaha f’ dan il- perijodu ta ’ xahar.
What MIRCERA contains
X’ fih MIRCERA
- The active substance is methoxy polyethylene glycol-epoetin beta.
- Is- sustanza attiva hija methoxy polyethylene glycol- epoetin beta.
1 ml (one vial) contains 50
1 ml (kunjett wieħed) fih 50
100, 200, 300, 400, 600, 1000 micrograms methoxy polyethylene glycol-epoetin beta.
100, 200, 300, 400, 600, 1000 mikrogramma ta ’ methoxy polyethylene glycol- epoetin beta.
- The other ingredients are sodium dihydrogen phosphate monohydrate, sodium sulphate,
- Is- sustanzi l- oħra huma sodium dihydrogen phosphate monohydrate, sodium sulphate, mannitol
mannitol (E421), methionine, poloxamer 188 and water for injections.
(E421), methionine, poloxamer 188 u ilma għall- injezzjonijiet.
What MIRCERA looks like and contents of the pack MIRCERA is a solution for injection in vial.
Id- Dehra ta ’ MIRCERA u l- kontenuti tal- pakkett MIRCERA hija soluzzjoni għall- injezzjoni f’ kunjett.
The solution is clear, colourless to slightly yellowish and free of visible particles.
Is- soluzzjoni hija ċara, bla kulur għal kemmxejn safranija u bla frak viżibbli.
MIRCERA comes in glass vials with grey laminated rubber stopper and flip-off cap made in aluminium and plastic.
MIRCERA huwa disponibbli f’ kunjetti tal- ħġieġ b’ tapp laminat griż tal- lasktu u għatu flip- off magħmul minn aluminju u plastik.
Each vial contains 1ml of solution.
Kull kunjett fih 1ml ta ’ soluzzjoni.
One pack contains 1 vial.
Pakkett wieħed fih kunjett wieħed.
1 D-79639 Grenzach-Wyhlen Germany
1 D- 79639 Grenzach Wyhlen Il- Ġermanja
Magyarország Roche (Magyarország) Kft.
268 Magyarország България Roche (Magyarország) Kft.
This leaflet was last approved in {MM/YYYY}.
269 Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
HOW TO SELF INJECT MIRCERA
KIF TINJETTA MIRCERA LILEK NNIFSEK
Always use MIRCERA exactly as your doctor has told you.
Dejjem uża MIRCERA eżatt kif qallek it- tabib tiegħek.
Check with your doctor or nurse if you are unsure.
Iċċekkja mat- tabib jew ners tiegħek jekk għandek xi dubji.
MIRCERA can be self-injected by yourself either under the skin or if you are on haemodialysis, through the haemodialysis line according to your doctor’s advice.
MIRCERA jista ’ jiġi njettat minnek nnifsek jew taħt il- ġilda jew jekk inti fuq emodijalisi, minn ġol - linja tal- emodijalisi skond il- parir tat- tabib tiegħek.
The vial does not contain any preservative and is to be used for one single injection only.
Il- kunjett sterili ma fih l- ebda preservattivi u għandu jintuża għall- injezzjoni waħda biss.
More than one dose must not be administered per vial.
M’ għandhiex tingħata aktar minn doża waħda kull kunjett.
Do not mix the solution with other injectable medicines.
Tħallatx is- soluzzjoni ma ’ mediċini oħra li jiġu njettati.
Store the vial in the outer carton box.
Aħżen il- kunjett fil- kartuna ta ’ barra.
244 Safety tips ● Remove the vial of MIRCERA from the refrigerator and allow it to reach room temperature in its outer carton box.
Pariri ta ’ sigurtà • Neħħi l- kunjett ta ’ MIRCERA mill- friġġ u ħallih jilħaq temperatura tal- kamra fil- kartuna ta ’ barra tiegħu.
This should take about 30 minutes after the package has been removed from the fridge. ● Make sure that the vial has not been removed from the fridge for more than a single period or for longer than 1 month. ● Do not use a vial that has been frozen and do not expose it to temperatures above 25 °C. ● Do not use a vial after the expiry date stated on the label. ● Only use the vial if the solution is clear, colourless (slightly yellow in colour is acceptable) and is free of visible particles. ● Do not shake the vial. ● When handling syringes, do not touch the needles. ● Keep the syringes in their wrappers until you are ready to prepare your dose.
Dan għandu jieħu madwar 30 minuta wara li l- pakkett jitneħħa mill- friġġ. • Kun żgur li l- kunjett ma nħariġx mill- friġġ għall- aktar minn perijodu wieħed jew għal aktar minn xahar. • Tużax kunjett li kien iffriżat u tesponiħx għal temperatura ta ’ ’ l fuq minn 25°C. • Tużax kunjett wara d- data ta ’ skadenza li tidher fuq it- tikketta. • Uża l- kunjett biss jekk is- soluzzjoni hija ċara, bla kulur (kulur kemmxejn safrani huwa aċċettabbli) u m’ għandhiex frak viżibbli. • Tħawwadx il- kunjett. • Meta qed tuża siringi, tmissx il- labar. • Żomm is- siringi fl- għata tagħhom sakemm tkun lest biex tipprepara d- doża tiegħek.
Getting started Assemble all of the supplies you will need for an injection on a clean surface:
Preparazzjoni tal- bidu Iġbor l- affarijiet kollha li se jkollok bżonn għall- injezzjoni fuq wiċċ nadif:
Included in the pack: ● One vial of MIRCERA Not included in the pack: ● A syringe ● One long needle to withdraw MIRCERA from the vial ● One short needle for injection ● Cleansing alcohol swabs ● Sterile gauze ● Container for the waste material
Inkluż fil- pakkett: • Kunjett wieħed ta ’ MIRCERA Mhux inkluż fil- pakkett: • Siringa • Labra twila biex tiġbed MIRCERA minn ġol- kunjett • Labra qasira għall- injezzjoni • Msielaħ tal- alkoħol biex tnaddaf • Garża sterili • Kontenitur għall- materjal ta ’ skart
The following instructions explain how to use MIRCERA vials to inject yourself.
270 L- istruzzjonijiet li ġejjin jispjegaw kif tuża kunjetti ta ’ MIRCERA biex tinjetta lilek innifsek.
Please read the instructions carefully and follow them step by step.
Jekk jogħġbok aqra sew l- istruzzjonijiet u imxi magħhom pass wara pass.
Wash your hands thoroughly before you start.
Aħsel idejk sew qabel ma tibda.
Preparing the dose of MIRCERA ● Remove the protective cap from the vial (1). ● Clean the rubber top of the vial with a cleansing alcohol swab.
Preparazzjoni tad- doża ta ’ MIRCERA • Neħħi l- għatu ta ’ protezzjoni mill- kunjett (1). • Naddaf il- wiċċ tal- lastku tal- kunjett b’ imselħa tal- alkoħol biex tnaddaf.
● Remove the syringe from the wrapping.
• Neħħi s- siringa mill- għata.
Do not touch the tip of the syringe. ● Take the needle guard containing the long needle and place it firmly on to the tip of the syringe (2).
Tmissx it- tarf tas- siringa. • Ħu l- għatu ta ’ protezzjoni tal- labra li fih il- labra twila u waħħlu sew mat- tarf tas- siringa (2).
● Remove the needle guard without touching the needle and keep the syringe with the needle in your hand. ● Insert the needle through the rubber stopper into the vial (3).
• Neħħi l- għatu ta ’ protezzjoni tal- labra mingħajr ma tmiss il- labra u żomm f’ idek is- siringa bil - labra. • Daħħal il- labra minn ġot- tapp tal- lasktu għal ġol- kunjett (3).
245 ● Hold the vial firmly in one hand and the syringe in the other and turn both upside down (4).
271 • Żomm sew il- kunjett f’ id waħda u s- siringa fl- id l- oħra u aqlibhom it- tnejn ta ’ taħt fuq (4).
● Keeping the vial upside down, slowly pull back on the plunger to fill the syringe with the solution to the line that matches the dose your doctor prescribed. ● Keeping the vial upside down and the needle in the vial, check for air bubbles in the syringe.
• Waqt li qed iżżomm il- kunjett rasu l- isfel, bil- mod iġbed lura l- planġer biex timla s- siringa bis - soluzzjoni sal- linja li taqbel mad- doża li ppreskrivilek it- tabib tiegħek. • Waqt li qed iżżomm il- kunjett rasu l- isfel u l- labra fil- kunjett, iċċekkja għall- bżieżaq tal- arja fis - siringa.
To remove air bubbles, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe.
Biex tneħħi l- bżieżaq tal- arja, tektek bil- mod is- siringa b’ subajk sakemm il- bżieżaq tal - arja jitilgħu fin- naħa ta ’ fuq tas- siringa.
Then slowly push the plunger up to push the solution and the air bubbles out of the syringe. ● Keep the tip of the needle in the liquid and once again pull the plunger back to the line on the syringe that matches your dose. ● Remove the syringe from the long needle while keeping the needle in the vial.
Wara imbotta l- planġer ’ l fuq biex timbotta s- soluzzjoni u l- bżieżaq tal- arja l- barra mis- siringa. • Żomm il- ponta tal- labra fil- likwidu u iġbed għal darba oħra l- planġer lura sal- linja fuq is- siringa li taqbel mad- doża tiegħek. • Neħħi s- siringa minn mal- labra t- twila waqt li tħalli s- siringa fil- kunjett.
Avoid touching the tip of the syringe. ● Take the needle guard containing the short injection needle and place it firmly on to the tip of the syringe (5).
Evità li tmiss it- tarf tas - siringa. • Ħu l- għatu ta ’ protezzjoni tal- labra li fih il- labra għall- injezzjoni l- qasira u waħħlu sew mat- tarf tas- siringa (5).
Injecting the solution If your doctor has advised you to inject MIRCERA through the haemodialysis line or into a vein, please administer your dose as shown by your health care professional.
Injezzjoni tas- soluzzjoni Jekk it- tabib tiegħek irrakkomandalek biex tinjetta MIRCERA minn ġol- linja tal- emodijalisi jew ġo vina, jekk jogħġbok amministra d- doża tiegħek kif urik il- professjonist fil- qasam tas- saħħa tiegħek.
If you are advised to inject MIRCERA under your skin please administer your dose as described below.
Jekk ġejt irrakkomandat biex tinjetta MIRCERA taħt il- ġilda jekk jogħġbok amministra d- doża tiegħek kif deskritt hawn taħt.
246 ● Select the injection site in the abdomen, thigh or arm (except your navel or waistline) (6).
272 • Għażel il- post għall- injezzjoni fiż- żaqq, fil- koxxa jew fid- dirgħajn (minbarra ż- żokra jew il - qadd) (6).
● Clean the skin, where the injection is to be made with a cleansing alcohol swab. ● Wait for the area to dry. ● Remove the needle guard. ● With one hand, pinch a fold of loose skin.
• Naddaf il- ġilda fejn se tagħmel l- injezzjoni b’ imselħa tal- alkoħol għat- tindif. • Stenna sakemm il- post ikun nixef. • Neħħi l- għatu ta ’ protezzjoni tal- labra. • B’ id waħda, oqros parti mill- ġilda li mhix miġbuda.
Insert the short injection needle into the pinched skin, holding the syringe like a pencil, use a quick “dart like” motion to insert the injection needle either straight up and down (90 degrees angle) or at a slight angle (45 degrees angle) into the skin, as shown by your health care professional (7).
Daħħal il- labra l- qasira għall- injezzjoni ġol- ġilda maqrusa, int u żżomm is- siringa qisha lapes, uża moviment ħafif “ qisek qed titfa ’ vleġġa ” biex iddaħħal il- labra għall- injezzjoni jew dritt ’ l fuq u ’ l isfel (angolu ta ’ 90 grad) jew f’ angolu żgħir (angolu ta ’ 45 grad) ġol- ġilda, kif ġejt muri mill- professjonist fil- qasam tas- saħħa tiegħek (7).
● Inject the solution by gently pushing the plunger all the way down. ● Pull the injection needle straight out of the skin. ● Press on the injection site with a small bandage or sterile gauze for several seconds. ● Do not massage the injection site.
• Injetta s- soluzzjoni b’ attenzjoni billi timbotta l- planġer ’ l isfel għal kollox. • Iġbed il- labra għall- injezzjoni dritt il- barra mill- ġilda. • B’ faxxa żgħira jew b’ garża sterili, għafas fuq il- post ta ’ l- injezzjoni għal diversi sekondi. • Timmassaġġjax il- post ta ’ l- injezzjoni.
Any bleeding may be covered with an adhesive bandage.
Kull fsada tista ’ titgħatta b’ faxxa li teħel.
Disposal The syringe, needles and all injection materials are intended for single use and must be discarded after the injection.
Rimi Is- siringa, labar u kull materjal għall- injezzjoni huma maħsuba għall- użu ta ’ darba u għandhom jintremew wara l- injezzjoni.
Dispose of the syringe and needles safely in a closed container.
Armi s- siringa u l- labar b’ mod sigur f’ kontenitur magħluq.
Medicines should not be disposed of via via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
Ask your pharmacist how to dispose of medicines that are no longer required.
Staqsi lill- ispiżjar tiegħek dwar kif għandek tarmi mediċini li m’ għandekx bżonn.
247 PACKAGE LEAFLET:
273 FULJETT TA ’ TAGĦRIF:
MIRCERA 30 micrograms/0.3 ml solution for injection in pre -filled syringe 40 micrograms/0.3 ml solution for injection in pre-filled syringe 50 micrograms/0.3 ml solution for injection in pre-filled syringe 60 micrograms/0.3 ml solution for injection in pre-filled syringe 75 micrograms/0.3 ml solution for injection in pre-filled syringe 100 micrograms/0.3 ml solution for injection in pre-filled syringe 120 micrograms/0.3 ml solution for injection in pre-filled syringe 150 micrograms/0.3 ml solution for injection in pre-filled syringe 200 micrograms/0.3 ml solution for injection in pre-filled syringe 250 micrograms/0.3 ml solution for injection in pre-filled syringe 360 micrograms/0.6 ml solution for injection in pre-filled syringe 400 micrograms/0.6 ml solution for injection in pre-filled syringe 600 micrograms/0.6 ml solution for injection in pre-filled syringe 800 micrograms/0.6 ml solution for injection in pre-filled syringe
MIRCERA 30 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlja għal- lest 40 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlja għal- lest 50 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlja għal- lest 60 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlja għal- lest 75 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlja għal- lest 100 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlja għal- lest 120 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlja għal- lest 150 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlja għal- lest 200 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlja għal- lest 250 mikrogramma/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlja għal- lest 360 mikrogramma/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlja għal- lest 400 mikrogramma/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlja għal- lest 600 mikrogramma/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlja għal- lest 800 mikrogramma/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlja għal- lest
What MIRCERA is and what it is used for 2.
X’ inhu MIRCERA u għalxiex jintuża 2.
This medicine is prescribed to you because you have anaemia caused by your chronic kidney disease and associated whith typical symptoms, such as tiredness, weakness and shortness of breath.
Din il- mediċina ġiet preskritta lilek minħabba li għandek anemija kkawżata mill- marda kronika tal - kliewi u assoċjata ma ’ sintomi tipiċi bħal għeja, dgħjufija u qtugħ ta ’ nifs.
This means that you have too few red blood cells and your haemoglobin level is too low (your body’s tissues might not receive enough oxygen).
Dan ifisser li int għandek ftit wisq ċelluli ħomor tad- demm u l- livell ta ’ l- emoglobina tiegħek huwa baxx wisq (it- tessuti ta ’ ġismek jistgħu ma jkunux qed jirċievu biżżejjed ossiġnu).
Like the natural hormone erythropoietin, MIRCERA increases the number of red blood cells and haemoglobin level in your blood.
Bħal l- ormon naturali eritropoetin, MIRCERA jżid in- numru ta ’ ċelluli ħomor tad- demm u jżid il- livell ta ’ l- emoglobina fid- demm tiegħek.
248 2.
274 2.
Take special care with MIRCERA
Oqgħod attent ħafna b’ MIRCERA
- A condition called Pure Red Cell Aplasia (stopped or reduced production of red blood cells) due
- Kundizzjoni magħrufa bħala Aplasija Pura taċ- Ċelluli l- Ħomor (produzzjoni mwaqqfa jew
to anti -erythropoietin antibodies was observed in some patients treated with other ESAs.
imnaqqsa taċ- ċelluli ħomor tad- demm) minħabba li kienu osservati antikorpi anti- eritropoetin f’ uħud mill- pazjenti kkurati b’ ESAs oħra.
- If your doctor suspects or confirms that you have these antibodies in your blood you must not be
- Jekk it- tabib tiegħek jissuspetta jew jikkonferma li inti għandek dawn l- antikorpi fid- demm
treated with MIRCERA.
tiegħek m’ għandekx tiġi kkurat b’ MIRCERA.
- Your doctor may initiate treatment with MIRCERA if your haemoglobin level is 10 g/dl
- It- tabib tiegħek jista 'jibda kura b’ MIRCERA jekk il- livell ta ’ l- emoglobina tiegħek huwa
(6.21 mmol/l) or less.
10 g/ dl (6. 21 mmol/ l) jew inqas.
After initiation of therapy, your doctor will seek to maintain your haemoglobin level between 10 and 12 g/dl (7.45 mmol/l).
Wara l- bidu tat- terapija, it- tabib tiegħek se jipprova jżomm il - livell ta ’ l- emoglobina tiegħek bejn 10 u 12 g/ dl (7. 45 mmol/ l).
- Your doctor will check the amount of iron in your blood before and during MIRCERA
- It- tabib tiegħek jiċċekkja l- kwantità ta ’ ħadid fid- demm tiegħek qabel u waqt il- kura b ’
Your doctor will check that you do not have other causes of anaemia and may perform blood tests or examine your bone marrow.
It- tabib tiegħek jiċċekkja li int m’ għandekx kawżi oħra ta ’ l- anemija u jista ’ jagħmel testijiet tad- demm jew jeżamina il - mudullun tal- għadam tiegħek.
You will not receive another ESA and your doctor will treat you for this condition.
Int ma tingħatax ESA ieħor u t- tabib tiegħek jikkurak għal din il - kundizzjoni.
Using other medicines Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
275 Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Using MIRCERA with food and drink Food and drink do not affect MIRCERA.
Meta tuża MIRCERA ma ’ l- ikel u max- xorb Ikel u xorb ma affettwax lil MIRCERA.
249 Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
Tqala u treddigħ Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
Driving and using machines MIRCERA does not affect your ability to drive and use machines.
Sewqan u tħaddim ta ’ magni MIRCERA ma taffettwax l- ħila tiegħek biex issuq u tħaddem magni.
- If you are not currently treated with an ESA
Jekk bħalisssa mhux qed tiġi kkurat b’ ESA
- If you are currently being treated with another ESA
- Jekk bħalisssa qed tiġi kkurat b’ ESA ieħor
If you use more MIRCERA than you should Please contact your doctor or pharmacist if you used too large a dose of MIRCERA as it may be necessary to perform some blood tests and interrupt your treatment.
276 Jekk tuża MIRCERA aktar milli suppost Jekk jogħġbok kellem lit- tabib jew lill- ispiżjar tiegħek jekk użajt doża kbira wisq ta ’ MIRCERA minħabba li jista ’ jkun hemm bżonn li jsiru xi testijiet tad- demm u li titwaqqaf temporanjament il- kura tiegħek.
250 If you stop using MIRCERA Treatment with MIRCERA is normally long-term.
Jekk tieqaf tuża MIRCERA Kura b’ MIRCERA normalment hija fit- tul.
It can, however, be stopped on the advice of your doctor at any time.
Madankollu jista ’ jitwaqqaf f’ kull waqt fuq parir tat- tabib tiegħek.
swollen tongue, face or throat, or swelling around the injection site, or make you feel light- headed, faint or cause you to collapse).
biex tieħu n- nifs; nefħa fl- ilsien, wiċċ jew griżmejn, jew nefħa madwar il- post ta ’ l- injezzjoni, jew iġġiegħlek tħossok sturdut, iħossok ħass ħażin jew tikkollassa).
Do not use MIRCERA after the expiry date which is stated on the outer carton and pre-filled syringe label after ‘EXP’.
277 Tużax MIRCERA wara d- data ta ’ skadenza li tidher fuq il- kartuna ta ’ barra u fuq it- tikketta tas- siringa mimlija għal- lest wara ‘ JIS ’.
Keep the pre-filled syringe in the outer carton in order to protect from light.
Żomm is- siringa mimlija għal- lest fil- kartuna ta ’ barra sabiex tilqa mid- dawl.
You may remove MIRCERA from the refrigerator and store it at a room temperature not above 25 °C for a single period of one month.
Tista ’ tneħħi MIRCERA mill- friġġ u taħżnu f’ temperatura tal- kamra mhux ’ l fuq minn 25°C għall - perijodu wieħed ta ’ xahar.
251 Ask your pharmacist how to dispose of medicines that are no longer required.
Staqsi lill - ispiżjar dwar kif għandek tarmi mediċini li m’ għandekx bżonn.
- The active substance is methoxy polyethylene glycol-epoetin beta.
- Is- sustanza attiva hija methoxy polyethylene glycol epoetin beta.
One pre-filled syringe with
Siringa waħda mimlija għal -
0.3 ml or 0.6 ml contains 30, 40, 50, 60, 75, 100, 120, 150, 200, 250 micrograms or 360, 400, 600, 800 micrograms.
lest b’ 0. 3 ml jew b’ 0. 6 ml fiha 30, 40, 50, 60, 75, 100, 120, 150, 200, 250 mikrogramma jew 360, 400, 600, 800 mikrogramma.
What MIRCERA looks like and contents of the pack MIRCERA 0.3 ml or 0.6 ml is a solution for injection in pre-filled syringe.
Id- Dehra ta ’ MIRCERA u l- kontenuti tal- pakkett MIRCERA 0. 3 ml jew 0. 6 ml hija soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest.
MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2.
MIRCERA huwa disponibbli f’ siringi mimlija għal- lest b’ tapp tal- planġer laminat u għatu tat- tarf b’ labra 27G1/ 2 waħda.
Each pre-filled syringe contains 0.3 ml or 0.6 ml.
Kull siringa mimlija għal- lest fiha 0. 3 ml jew 0. 6 ml.
One pack contains 1 pre-filled syringe.
Daqsijiet tal- pakkett ta ’ 1 u ta ’ 3.
Marketing Authorisation Holder Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW Ir- Renju Unit
Manufacturer Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Germany
Roche Pharma AG Emil- Barell- Strasse 1 D- 79639 Grenzach- Wyhlen Il- Ġermanja
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
278 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq: