qanastek/EMEA-V3 huggingface dataset:
Keep the container in the outer carton, in order to protect from light
Żomm il- kontenitur fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl
For intravenous use after dilution
Għall- użu fil- vini wara dilwizzjoni
Vial of 10 ml (10 mg/ ml)
Kunjett ta ’ 10 ml (10 mg/ ml)
62 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
66 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
MabThera 500 mg concentrate for solution for infusion
MabThera 500 mg konċentrat għal soluzzjoni għal infużjoni
1 vial contains 10 mg/ ml rituximab.
Kunjett wieħed fih 10 mg/ ml ta ’ rituximab.
Concentrate for solution for infusion 1 vial of 50 ml
Konċentrat għal soluzzjoni għal infużjoni Kunjett wieħed ta ’ 50 ml
For intravenous use after dilution Read the package leaflet before use
Għall- użu ġol- vina wara dilwizzjoni Aqra l- fuljett ta ’ tagħrif qabel l- użu
63 10.
67 10.
64 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
68 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL - PAKKETTI Ż- ŻGĦAR EWLENIN
For intravenous use after dilution
Għall- użu ġol- vina wara dilwizzjoni
Vial of 50 ml (10 mg/ ml)
Kunjett ta ’ 50 ml (10 mg/ ml)
MABTHERA in RA Patient Alert Card This alert card contains important safety information that you need to be aware of before you are given MABTHERA and
69 KLIEM GĦALL- KARTUNA TA ’ TWISSIJA TAL- PAZJENT GĦALL- ARTRITE REWMATIKA
Dates of MABTHERA Treatment:
Dati ta ’ Kura b’ MABTHERA:
Start: ____________________
MABTHERA fil- Kartuna ta ’ Twissija tal - Pazjent b’ RA Bidu:
during treatment with MABTHERA. • Show this card to any doctor involved
kura b’ MABTHERA.
the MABTHERA package leaflet for more
Uri din il- kartuna lil kull tabib involut fil- kura tiegħek, mhux biss lit- tabib speċjalista tiegħek li qed jippreskrivih
information. • Please make sure you also have a list of all your
• Ara l- fuljett ta ’ tagħrif ta ’ MABTHERA għal aktar informazzjoni. • Jekk jogħġbok kun ċert/ a li jkollok miegħek lista tal- mediċini l- oħra kollha tiegħek f’ kull vista
other medicines with you at any visit to a health care professional.
għand professjonist fil- kura tas- saħħa.
MABTHERA may increase the risk of getting
MABTHERA jista ’ jżid ir- riskju li tieħu
infections.
infezzjonijiet.
Patient’ s Name: ____________________ Doctor’ s Name: ____________________
Isem tat- Tabib: ____________________
Prior to MABTHERA treatment
Numru tat- telefon tat- Tabib: ____________________ Qabel kura b’ MABTHERA
Doctor’ s Phone: ____________________
PERESS LI L- IMMUNOSOPPRESSJONI
You should not be treated with • MABTHERA if you have an active infection or serious problem with your immune system.
Inti m’ għandekx tiġi kkurat/ a b’ MABTHERA jekk għandek infezzjoni attiva jew problema serja bis- sistema immuni tiegħek.
AS THE IMMUNOSUPRESSION CAUSED BY MABTHERA CAN LAST FOR SEVERAL MONTHS, SIDE EFFECTS MAY OCCUR EVEN AFTER YOU HAVE STOPPED TREATMENT.
IKKAWŻATA MINN MABTHERA TISTA ’ DDUM GĦAL BOSTA XHUR, EFFETTI SEKONDARJI JISTGĦU JSEĦĦU ANKE ’ WARA LI INTI TKUN WAQQAFT IL- KURA.
TELL YOUR DOCTOR IF YOU ARE TAKING OR HAVE PREVIOUSLY TAKEN MEDICINES WHICH MAY AFFECT YOUR IMMUNE SYSTEM, SUCH AS CHEMOTHERAPY OR IMMUNOSUPPRESSIVE AGENTS
GĦID LIT- TABIB TIEGĦEK JEKK QED TIEĦU JEW ĦADT QABEL MEDIĊINI LI JISTGĦU JAFFETTWAW IS- SISTEMA IMMUNI TIEGĦEK, BĦAL KIMOTERAPIJA JEW SUSTANZI IMMUNOSOPPRESSIVI
PLEASE THEREFORE KEEP THIS CARD WITH YOU FOR 24 MONTHS AFTER THE LAST DOSE OF MABTHERA,
MIEGĦEK GĦAL 24 XAHAR WARA L- AĦĦAR DOŻA TA ’ MABTHERA,
During or after treatment with MABTHERA If you develop symptoms suggestive of infections, such as fever, persistent cough, weight loss, or listlessness, seek medical attention immediately.
Waqt jew wara kura b’ MABTHERA Jekk tiżviluppa sintomi li jissuġġerixxu infezzjoni, bħal deni, sogħla persistenti, telf ta ’ piż, jew letarġija, fittex attenzjoni medika minnufih.
Very rarely, some patients taking MabThera have had a serious brain infection called Progressive Multifocal leukoencephalopathy (PML) which has been fatal.
Rari ħafna, xi pazjenti li jieħdu MabThera kellhom infezzjoni serja fil- moħħ imsejjħa Lewkoenċefalopatija Multifokali Progressiva (PML) li kienet fatali.
Symptoms of PML include memory loss, trouble thinking, difficulty with walking and/or loss of vision.
Sintomi ta ’ PML jinkludu telf ta ’ memorja, problemi biex taħseb, diffikultà biex timxi u/ jew telf tal- vista.
You should tell your doctor immediately if you experience any of these symptoms.
Għandek tgħid lit- tabib tiegħek minnufih jekk ikollok xi wieħed minn dawn is- sintomi.
67 PACKAGE LEAFLET:
71 FULJETT TA ’ TAGĦRIF:
MabThera 100 mg concentrate for solution for infusion rituximab
MabThera 100 mg konċentrat għal soluzzjoni għal infużjoni rituximab
Read this leaflet carefully before you start taking this medicine.
Aqra sew dan il- fuljett kollu qabel tibda tieħu din il- mediċina.
please tell your doctor, nurse or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib, lin- ners jew lill- ispiżjar tiegħek.
What MabThera is and what it is used for 2.
X’ inhu MabThera u għalxiex jintuża 2.
Before you use MabThera 3.
Qabel ma tuża MabThera 3.
How to use MabThera 4.
Kif għandek tuża MabThera 4.
How to store MabThera 6.
Kif taħżen MabThera 6.
WHAT MABTHERA IS AND WHAT IT IS USED FOR
X’ INHU MABTHERA U GĦALXIEX JINTUŻA
MabThera contains an antibody (rituximab) which is a type of protein.
MabThera fih antikorp (rituximab) li huwa tip ta ’ proteina.
Rituximab binds to the surface of a type of white blood cell, the B lymphocyte.
Rituximab jeħel mal- wiċċ ta ’ tip ta ’ ċellula bajda tad- demm, il- limfoċite B.
When rituximab binds to the surface of this cell it causes the cell to die.
Meta rituximab jeħel mal- wiċċ ta ’ din iċ- ċellula huwa jikkawża l - mewt taċ- ċellula.
M abThera may be used for the treatment of three different conditions.
MabThera jista ’ jintuża għall- kura ta ’ tliet kundizzjonijiet differenti.
Your doctor may prescribe MabThera for the treatment of:
It- tabib tiegħek jista ’ jordna MabThera għall- kura ta ’:
a) Non-Hodgkin’s Lymphoma Non-Hodgkin’s lymphoma is a disease of the lymphatic system.
a) Limfoma Mhux ta ’ Hodgkin Il- limfoma mhux ta ’ Hodgkin hija marda tas- sistema limfatika.
B lymphocytes are involved in the cause of some of the symptoms you may have.
Il- limfoċiti B huma involuti fil- kawża ta ’ xi wħud mis- sintomi li jista ’ jkollok.
Ma bThera can be used alone or with other medicines your doctor may prescribe to induce remission of your disease.
MabThera jista ’ jintuża waħdu jew ma ’ mediċini oħra li t - tabib tiegħek jista ’ jordna biex jinduċi remissjoni tal- marda tiegħek.
MabThera may be used as a continuous (maintenance) treatment for 2 years in patients who have responded to induction treatment.
MabThera jista ’ jintuża bħala kura kontinwa (ta ’ manteniment) għal sentejn fil- pazjenti li jkunu rrispondew għall- kura ta ’ induzzjoni.
b) Chronic lymphocytic leukaemia Chronic lymphocytic leukaemia (CLL) is the most common form of adult leukaemia.
b) Lewkimja limfoċitika kronika Lewkimja limfoċitika kronika (CLL) hija l- aktar forma komuni ta ’ lewkimja fl- adulti.
CLL affects a particular lymphocyte, the B cell, which originates in the bone marrow and develops in the lymph nodes.
CLL taffettwa limfoċit partikolari, iċ- ċellula B, li toriġina fil- mudullun ta ’ l- għadam u tiżviluppa fil- glandoli tal- limfa.
Patients with CLL have too many abnormal lymphocytes, which accumulate mainly in the bone marrow and blood.
Pazjenti b’ CLL għandhom limfoċiti mhux normali żejda, li jakkumulaw fil- biċċa l- kbira fil- mudullun ta ’ l- għadam u fid- demm.
The proliferation of these abnormal B-lympho cytes is the cause of symptoms you may have.
Il- proliferazzjoni ta ’ dawn il- limfoċiti B mhux normali hija l- kawża tas - sintomi li jista ’ jkollok.
MabThera in combination with chemotherapy destroys these cells which are gradually removed from the body by biological processes.
MabThera flimkien ma ’ kimoterapija jkisser dawn iċ- ċelluli li jitneħħew b’ mod gradwali mill- ġisem permezz ta ’ proċessi bijoloġiċi.
c) Rheumatoid arthritis MabThera is used for the treatment of rheumatoid arthritis.
ċ) Artrite Rewmatika MabThera jintuża għall- kura ta ’ l- artrite rewmatika.
Rheumatoid arthritis is a disease of the joints.
L- artrite rewmatika hija marda tal- ġogi.
B lymphocytes are involved in the cause of some of the symptoms you have.
Il - limfoċiti B huma involuti fil- kawża ta ’ xi wħud mis- sintomi li għandek.
MabThera is used to treat rheumatoid arthritis in people who have already tried some other medicines which have either stopped working or have not worked well enough.
MabThera jintuża sabiex tiġi kkurata l- artrite rewmatika f’ persuni li diġà jkunu ppruvaw mediċini oħra li jew ikunu waqfu jaħdmu jew ma jkunux ħadmu tajjeb biżżejjed.
MabThera is usually taken together with another medicine called methotrexate.
MabThera ġeneralment jittieħed ma ’ mediċina oħra msejħa methotrexate.
BEFORE YOU USE MABTHERA
QABEL MA TUŻA MABTHERA
68 Do not take MabThera
Tieħux MabThera
- if you are allergic to rituximab, to other similar proteins, or to any of the other ingredients in the
- jekk int allerġiku/ a għal rituximab, proteini oħra simili, jew għal xi sustanzi oħra fis- soluzzjoni
- if you have an active infection
- jekk għandek infezzjoni attiva
If you are not sure about this, you should ask your doctor who will inform you accordingly.
Jekk m’ intix ċert/ a dwar dan, inti għandek tistaqsi lit- tabib tiegħek li jinfurmak kif meħtieġ.
Tell your doctor before your MabThera treatment
Qabel il- kura tiegħek b’ MabThera għid lit- tabib tiegħek
- if you think you have hepatitis infection now or have had it in the past.
- jekk taħseb li għandek infezzjoni ta ’ l- epatite issa jew kellek waħda fil- passat.
In a few cases, patients
Fi ftit każijiet,
who have had hepatitis B might have a repeated attack of hepatitis, which can be fatal in very rare cases.
pazjenti li kellhom l- epatite B jista ’ jkollhom attakk ripetut ta ’ l- epatite li f’ każijiet rari ħafna jista ’ jkun fatali.
Patients with a history of hepatitis B infection will be carefully checked by their doctor for signs of active hepatitis B.
Pazjenti bi storja ta ’ infezzjoni ta ’ l- epatite B se jiġu ċċekkjati bir- reqqa mit - tabib tagħhom għal sinjali ta ’ epatite B attiva.
- if you are taking treatment for high blood pressure.
- jekk qed tieħu kura għall- pressjoni għolja tad- demm.
You may be asked not to take your
Inti tista ’ tintalab biex ma tiħux il -
medicines 12 hours before your infusion of MabThera.
mediċini tiegħek 12- il siegħa qabel l- infużjoni ta ’ MabThera.
Some people have a fall in their blood pressure during the infusion.
F’ xi nies titbaxxa l- pressjoni tad - demm tagħhom waqt l- infużjoni.
- if you have ever had heart disease (i.e. angina, palpitations, or heart failure) or a history of
- jekk xi darba kellek mard tal- qalb (jiġifieri anġina, palpitazzjonijiet, jew insuffiċjenza tal- qalb)
breathing problems.
jew storja ta ’ problemi tan- nifs.
Your doctor may need to take special care of you during your treatment with MabThera (in any of the above cases).
It- tabib tiegħek jista ’ jkollu bżonn jieħu kura speċjali tiegħek waqt il- kura tiegħek b’ MabThera (f’ kull wieħed mill- każijiet ta ’ fuq).
Take special care with MabThera
Oqgħod attent ħafna b’ MabThera
- tell your doctor if you are taking or have previously taken medicines which may affect your
- għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt qabel mediċini li jista ’ jkollhom effett fuq is -
immune system, such as chemotherapy or immunosuppressive agents.
sistema immuni tiegħek, bħal kimoterapija jew sustanzi immunosoppressivi.
If you have rheumatoid arthritis also tell your doctor
Jekk għandek artrite rewmatika għid ukoll lit- tabib tiegħek
- if you think you may have an infection, even a mild one like a cold.
- jekk taħseb li jista ’ jkollok infezzjoni, anki waħda ħafifa bħal riħ.
The cells that are affected
Iċ- ċelluli li huma affettwati
by MabThera help to fight infection and you should wait until the infection has passed before you are given MabThera.
b’ MabThera jgħinu biex tkun miġġielda l- infezzjoni u inti għandek tistenna sakemm tgħaddi l - infezzjoni qabel ma tingħata MabThera.
Also please tell your doctor if you had a lot of infections in the past or suffer from severe infections.
Jekk jogħġbok għid ukoll lit- tabib tiegħek f’ każ li kellek ħafna infezzjonijiet fil- passat jew inkella tbati minn infezzjonijiet akuti.
- if you think you may need any vaccinations in the near future, including vaccinations needed to
- jekk taħseb li jista ’ jkollok bżonn xi tilqimiet fil- futur qrib, fosthom tilqimiet meħtieġa biex
travel to other countries.
tivvjaġġa lejn pajjiżi oħra.
Some vaccines should not be given at the same time as MabThera or in the months after you receive MabThera.
Xi vaċċini m’ għandhomx jingħataw fl- istess żmien ma ’ MabThera jew fix- xhur wara li tirċievi MabThera.
Your doctor will check if you should have any vaccines before you receive MabThera.
It- tabib tiegħek se jiċċekkja jekk għandekx tieħu xi vaċċini qabel ma tirċievi MabThera.
At present, there is not very much information about MabThera treatment in children and adolescents; if you are under 18 years of age, you or your parent/career should ask your doctor if MabThera is right for you.
Attwalment, m’ hemmx wisq informazzjoni dwar il- kura b’ MabThera fit- tfal u adoloxxenti; u jekk inti taħt it- 18- il sena, inti jew il- ġenitur/ min jieħu ħsiebek għandkom issaqsu lit- tabib tiegħek jekk MabThera huwiex tajjeb għalik.
Taking other medicines Before starting treatment, make sure your doctor knows if you are taking or have recently taken any other medicines (including those you have bought for yourself from a pharmacy, supermarket or health store).
Meta tieħu mediċini oħra Qabel ma tibda l- kura, kun ċert li t- tabib tiegħek jaf jekk qiegħed/ qiegħda tieħu jew ħadt dan l- aħħar xi mediċini oħra (anki dawk li xtrajt inti stess minn spiżerija, supermarket jew ħanut li jbigħ prodotti tas - saħħa.
This is extremely important, as using more than one medicine at the same time can strengthen or weaken their effect.
Dan huwa importanti ħafna għax l- użu ta ’ aktar minn mediċina waħda fl- istess ħin jista ’ jqawwi jew idgħajjef l- effett tagħhom.
MabThera should not be used with other drugs unless your doctor has told you it is safe to do so.
MabThera m’ għandux jintuża ma ’ mediċini oħra sakemm it- tabib tiegħek ma jkunx qallek li m’ hemmx periklu li tagħmel dan.
Pregnancy and breast-feeding You must tell your doctor if you are pregnant, if you think you are pregnant or if you intend to become pregnant.
Tqala u treddigħ Inti għandek tgħid lit- tabib tiegħek jekk inti tqila, jekk taħseb li inti tqila jew jekk qed tippjana biex toħroġ tqila.
This is because MabThera is an antibody and can cross the placenta and affect your baby.
Dan minħabba li MabThera huwa antikorp u jista ’ jgħaddi mill- plaċenta u jaffettwa lit - tarbija tiegħek.
If you can get pregnant, you must use an effective method of birth control during therapy with MabThera and for 12 months after the last time you were treated with MabThera.
Jekk tista ’ tinqabad tqila, inti għandek tuża metodu effettiv ta ’ kontroll tat- twelid waqt terapija b’ MabThera u għal 12- il xahar wara l- aħħar darba li tkun ġejt ikkurat b’ MabThera.
MabThera might also get into breast milk and so you should not breast-feed your baby during therapy with MabThera and for 12 months after the last time you were treated with MabThera
MabThera jista ’ jgħaddi wkoll għal ġol- ħalib tas- sider u għalhekk inti m’ għandekx tredda ’ lit- tarbija tiegħek waqt terapija b’ MabThera u għal 12- il xahar wara l- aħħar darba li ġejt ikkurat b’ MabThera.
Driving and using machines It is not known whether MabThera has an effect on your ability to drive a car or use machines.
73 Sewqan u tħaddim ta ’ magni Mhux magħruf jekk MabThera għandux effett fuq il- ħila tiegħek li ssuq karozza jew tħaddem magni.
HOW TO USE MABTHERA
KIF GĦANDEK TUŻA MABTHERA
MabThera is an infusion (“drip”) which is given directly into your veins.
MabThera huwa infużjoni (“ dripp ”) li tingħata direttament fil- vini tiegħek.
You will be observed by a health care professional while you are being given MabThera in case you have any side effects during the infusion.
Inti se tkun osservat/ a minn professjonist tal- kura tas- saħħa waqt li tkun qiegħed/ qiegħda tingħata MabThera f’ każ li jkollok xi effetti sekondarji waqt l- infużjoni.
Before the infusion is given you will be given medicines to prevent or reduce possible reactions to MabThera.
Qabel ma tingħata l- infużjoni inti se tingħata mediċini biex jimpedixxu jew inaqqsu r- reazzjonijiet possibbli għal MabThera.
a) If you are being treated for non-Hodgkin’s Lymphoma If you are treated with MabThera alone you will receive infusions at weekly intervals for a total of four infusions (days 1, 8, 15 and 22), so that the a course of treatment usually lasts for 22 days.
a) Jekk qed tiġi kkurat/ a għal Limfoma mhux ta ’ Hodgkin Jekk qed tiġi kkurat b’ MabThera waħdu inti se tirċievi infużjonijiet f’ intervalli ta ’ ġimgħa għal total ta ’ erba ’ infużjonijiet (ġurnata 1, 8, 15 u 22), sabiex kors ta ’ kura ġeneralment idum 22 jum.
Repeated treatment courses with MabThera are possible.
Korsijiet ta ’ kura ripetuta b’ MabThera huma possibbli.
If you are treated with MabThera in combination with other medicines, you will receive an infusion of MabThera on the same day as the other medicines, which are usually given 8 times at 3-week intervals.
Jekk tiġi kkurat/ a b’ MabThera flimkien ma ’ mediċini oħra, inti se tirċievi infużjoni ta ’ MabThera fl- istess jum bħall- mediċini l- oħra, li ġeneralment jingħataw 8 darbiet f’ intervalli ta ’ 3 ġimgħat minn xulxin.
If you have responded to treatment and are further treated with Ma bThera as continuous (maintenance) treatment, you will receive one infusion of MabThera every 3 months for two years.
Jekk irrispondejt għall- kura u tkompli tiġi kkurat b’ MabThera bħala kura kontinwa (ta ’ manteniment), inti se tirċievi infużjoni waħda ta ’ MabThera kull 3 xhur għal sentejn.
Your doctor may change the number of infusions depending on your disease.
It- tabib tiegħek jista ’ jbiddel in- numru ta ’ infużjonijiet skond il - marda tiegħek.
b) If you are being treated for chronic lymphocytic leukemia When you are treated with Mab Thera in combination with chemotherapy, you will receive MabThera infusions on day 0 cycle 1 then day 1 of each cycle for 6 cycles in total.
b) Jekk qed tiġi kkurat/ a għall- lewkimja limfoċitika kronika Meta tkun qed tiġi kkurat b’ MabThera flimkien ma ’ kimoterapija, inti se tirċievi infużjonijiet ta ’ MabThera f’ ġurnata 0 ta ’ ċiklu 1 u wara f’ ġurnata 1 ta ’ kull ċiklu għal total ta ’ 6 ċikli.
Each cycle has a duration of 28 days.
Kull ċiklu għandu tul ta ’ 28 ġurnata.
The chemotherapy should be given after the MabThera infusion.
Il- kimoterapija għandha tingħata wara l- infużjoni ta ’ MabThera.
Your doctor will decide if you should receive concomitant supportive therapy.
It- tabib tiegħek se jiddeċiedi jekk għandekx tirċievi terapija ta ’ sapport fl- istess waqt.
c) If you are being treated for rheumatoid arthritis Each course of treatment is made up of two separate infusions which are given 2 weeks apart.
ċ) Jekk qed tiġi kkurat/ a għall- artrite rewmatika Kull kors ta ’ kura huwa magħmul minn żewġ infużjonijiet separati li jingħataw ġimagħtejn ’ il bogħod minn xulxin.
Repeated courses of treatment with MabThera are possible.
Korsijiet ripetuti ta ’ kura b’ MabThera huma possibbli.
Depending on the signs and symptoms of your disease, your doctor will decide when you should receive more MabThera.
Jiddependi mis- sinjali u s- sintomi tal- marda tiegħek, it- tabib tiegħek se jiddeċiedi meta għandek tirċievi aktar MabThera.
This may be months from now.
Dan jista ’ jkun xhur mil- lum.
Like all medicines, MabThera can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, MabThera jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Most side effects are mild to moderate but some may be serious and require treatment.
Il- biċċa l- kbira ta ’ l- effetti sekondarji huma ħfief għal moderati iżda xi wħud jistgħu jkunu serji u jkollhom bżonn ta ’ kura.
Rarely, some of these reactions have been fatal.
Rarament, xi wħud minn dawn ir- reazzjonijiet kienu fatali.
Infusion reactions During or within the first 2 hours of the first infusion you may develop fever, chills and shivering.
Reazzjonijiet għall- infużjoni Waqt jew sa l- ewwel sagħtejn mill- ewwel infużjoni inti tista ’ tiżviluppa deni, kesħa u tregħid.
Less frequently, some patients may experience blisters, itching, sickness, tiredness, headache, breathing difficulties, tongue or throat swelling, itchy or runny nose, vomiting, flushing or palpitations.
B’ mod anqas frekwenti, xi pazjenti jistgħu jesperjenzaw infafet, tekil tal- ġilda, taqligħ, għeja, uġigħ ta ’ ras, diffikultajiet tan- nifs, nefħa fl- ilsien jew fil- gerżuma, imnieħer iqattar jew jieklok, rimettar, fwawar jew palpitazzjonijiet.
If you have heart disease or angina, these reactions might get worse.
Jekk għandek mard tal- qalb jew anġina, dawn ir- reazzjonijiet jistgħu jmorru għall- agħar.
Tell the person giving you the infusion immediately if you develop any of these symptoms, as the infusion may need to be slowed down or stopped for a while.
Għid immedjatament lill- persuna li tkun qiegħda tagħtik l- infużjoni jekk tiżviluppa xi wieħed minn dawn is- sintomi, billi l- infużjoni għandha mnejn ikollha bżonn tingħata aktar bil- mod jew titwaqqaf għal xi ħin.
You may require additional treatment such as an antihistamine or paracetamol.
Inti jista ’ jkollok bżonn ta ’ kura addizzjonali bħal antiħistamina jew paraċetamol.
When these symptoms go away, or improve, the infusion can be continued.
Meta dawn is- sintomi jmorru, l- infużjoni tkun tista ’ titkompla.
These reactions are less likely to happen after the second infusion.
Dawn ir- reazzjonijiet huma anqas probabbli li jseħħu wara t- tieni infużjoni.
Infections Tell your doctor after your MabThera treatment if you get any symptoms of an infection, for example fever, cough, sore throat, burning pain when passing urine, or you start to feel weak or generally unwell.
74 Infezzjonijiet Għid lit- tabib tiegħek wara l- kura tiegħek b’ MabThera jekk tħoss xi sintomi ta ’ infezzjoni, pereżempju deni, sogħla, griżmejk juġgħuk, ħruq li jweġġa ’ meta tagħmel l- awrina, jew tibda tħossok dgħajjef jew ma tiflaħx b’ mod ġenerali.
You might get infections more easily following MabThera therapy.
Inti jistgħu jaqbduk infezzjonijiet aktar faċilment wara terapija b’ MabThera.
Often these are colds, but there have been cases of pneumonia or urinary infections.
Ħafna drabi dawn ikunu rjiħat, iżda kien hemm każijiet ta ’ pnewmonja jew infezzjonijiet urinarji.
70 Very rarely, some patients taking MabThera have had a serious brain infection, which has been fatal.
Rari ħafna, xi pazjenti li kienu qed jieħdu MabThera kellhom infezzjonijiet serji f’ moħħom li kienu fatali.
Tell your doctor immediately if you have memory loss, trouble thinking, difficulty with walking or loss of vision.
Għid lit- tabib tiegħek immedjatament jekk għandek telf fil- memorja, diffikultà biex taħseb, diffikultà fil- mixi jew telf tal- vista.
Other reactions a) If you are being treated for non-Hodgkin’s Lymphoma or chronic lymphocytic leukaemia The most commonly reported side effects due to MabThera (reported in more than 1 out of 10 patients are: • infections such as pneumonia (bacterial) and herpes (viral) or bronchial tube inflammation (bronchitis) • low number of white blood cells, with or without fever • allergic reactions after infusion • nausea • skin rashes, itching ,bald spots on the scalp fever, chills, physical weakness, headache • decreased immunity (decreased IgG levels)
Reazzjonijiet oħra a) Jekk qed tiġi kkurat għal Limfoma mhux ta ’ Hodgkin jew lewkimja limfoċitika kronika L- effetti sekondarji irrapportati b’ mod l- aktar komuni kkawżati minn MabThera (irrapportati f’ aktar minn pazjent wieħed minn kull 10) huma: • infezzjonijiet bħal pnewmonja (ikkawżata minn batterja) u herpes (ikkawżata minn virus) jew infjammazzjoni tat- tubu tal- bronki (bronkite) • numru baxx ta ’ ċelluli bojod tad- demm, bid- deni jew bla deni • reazzjonijiet allerġiċi wara infużjoni • tqalligħ • raxx fil- ġilda, ħakk, partijiet bla xagħar fil- qurrija, deni, rogħda, debbulizza fiżika, uġigħ ta ’ ras • immunità mnaqqsa (livelli ta ’ IgG imnaqqsa)
Common side effects due to MabThera (reported in more than 1 out of 100 patients) include: • Infections such as sepsis and pneumonia (bacterial), herpes (viral) or candidal (fungal) bronchial tube and sinuses inflammation, or other general infections of unknown origin. • Low number of red blood cells, low number of platelets in the blood, low number of red and white blood cells and platelets. • Allergic reactions (hypersensitivity) • High sugar level in the blood, weight loss, excess fluid in the face and the body, increased blood levels of the enzyme (LDH), low blood level of calcium. • Abnormal sensations of the skin, such as numbness, tingling, pricking, burning, a creeping skin sensation, decreased sense of touch.
Effetti sekondarji komuni kkawżati minn MabThera (irrapportati f’ aktar minn pazjent wieħed minn kull 100) jinkludu: • Infezzjonijiet bħal sepsi u pnewmonja (ikkawżata minn batterja), herpes (ikkawżata minn virus) jew infjammazzjoni tat- tubu tal- bronki u tas- sinusis ikkawżata minn kandida (mill - moffa), jew infezzjonijiet ġenerali oħra ta ’ oriġini mhux magħrufa • Numru baxx ta ’ ċelluli ħomor tad- demm, numru baxx ta ’ plejtlits fid- demm, numru baxx ta ’ ċelluli ħomor u bojod tad- demm u ta ’ plejtlits • Reazzjonijiet allerġiċi (sensittività eċċessiva) • Livelli għolja ta ’ zokkor fid- demm, telf ta ’ piż, fluwidu żejjed fil- wiċċ u fil- ġisem, żjieda fil - livelli fid- demm ta ’ l- enżima (LDH), livell baxx ta ’ calcium fid- demm. • Sensazzjonijiet mhux normali fil- ġilda, bħal tnemnim, tingiż, qris, ħruq, tħoss bħal dud miexi fuq il- ġilda, sensazzjoni tal- mess imnaqqsa.
Feeling restless, difficulty falling asleep, becoming red in the face and bruising of the skin as a consequence of dilation of the blood vessels, dizziness, anxiety. • An increased production of tears, secretion and shedding disorders, inflammation of the eye (conjunctivitis). • Ringing sound in the ears, ear pain. • Heart disorders (heart attack, irregular heart rate, abnormally fast heart rate). • High or low blood pressure, a rise in blood pressure upon assuming an upright posture. • Inflammation, irritation and / or tightness of the lungs, throat and / or sinuses, shortness of breath, too little oxygen reaching the body organs, coughing. • Vomiting, diarrhoea, pain in the abdomen, irritation and /or ulceration of the throat and the mouth, difficulties in swallowing, constipation, indigestion.
Tħossok aġitat/ a, diffikultà biex torqod, il- wiċċ jiħmar u tbenġil fil- ġilda bħala konsegwenza tad- dilatazzjoni tal- kanali tad- demm, sturdament, ansjetà • Żjieda fil- produzzjoni tad- dmugħ, disturbi fis- sekrezzjoni u tat- tqaxxir, infjammazzjoni ta ’ l - għajn (konġuntivite) Żanżin fil- widnejn, uġigħ fil- widnejn • Disturbi fil- qalb (attack ta ’ qalb, rata tal- qalb irregolari, rata tal- qalb mgħaġġla b’ mod mhux normali • Pressjoni tad- demm għolja jew baxxa, tnaqqis fil- pressjoni tad- demm hekk kif tqum bil - wiefqa. • Infjammazzjoni, irritazzjoni u / jew tagħfis fil- pulmun, griżmejn u / jew sinusis, qtugħ ta ’ nifs, ftit wisq ossiġnu jilħaq l- organi tal- ġisem, sogħla. • Rimettar, dijarea, uġigħ fl- addome, irritazzjoni u / jew ulċerazzjoni fil- griżmejn u fil- ħalq, diffikultajiet biex tibla ’, stitkezza, indiġestjoni.
Eating disorders: decrease in the amount of food eaten with a consequential dangerous loss in weight. • Skin disorders, burning sensation of the skin, itching, increased perspiration, night sweats. • Musculoskeletal disorders, abnormal increase in tightness of muscle tone, pain, joint pain, muscle pain, back and neck pain. • General disorders, tumour pain, becoming markedly red in the face and other areas of the skin, general discomfort or uneasiness, flu syndrome, fatigue, shaking, multi-organ dysfunction.
Disturbi biex tiekol: tnaqqis fl- ammont ta ’ ikel li jittiekel b’ konsegwenza ta ’ telf perikoluż fil- piż. • Disturbi fil- ġilda, sensazzjoni ta ’ ħruq fil- ġilda, ħakk, żjieda fl- għaraq, għaraq bil- lejl. • Disturbi muskolu- skeltrali, żjieda mhux normali fl- egħbusija tat- ton tal- muskoli, uġigħ, uġigħ fil- ġogi, uġigħ fid- dahar u fl- għonq. • Disturbi ġenerali, uġigħ tat- tumur, ssir aħmar ħafna fil- wiċċ u f’ postijiet oħra fil- ġilda, skomdu ġenerali jew ma tħossokx sew,, sindrome ta ’ riħ, għeja, tregħid, disfunzjoni ta ’ diversi organi
Uncommon side effects due to MabThera (reported in more than 1 out of 1000 patients) include: • abnormal clotting, decrease of blood cells production, autoimmune decrease of red blood cells, swollen/enlarged lymph nodes • low mood and loss of interest or pleasure in usual activities, nervousness • taste changes • heart disorder (heart attack, abnormally fast heart rate, reduced heart rate, irregular heart rate, chest pain) • inflammation, irritation and/or tightness of the lungs, asthma, shortness of breath • enlargement of the abdomen • pain at the infusion site
75 Effetti sekondarji mhux komuni kkawżati minn MabThera (irrapportati f’ aktar minn pazjent wieħed minn kull 1000) jinkludu: • tgħaqid mhux normali tad- demm, tnaqqis fil- produzzjoni ta ’ ċelluli tad- demm, tnaqqis awto - immuni ta ’ ċelluli ħomor tad- demm, glandoli tal- limfa minfuħa/ akbar mis- soltu • burdata depressa u nuqqas ta ’ interess jew pjaċir fl- attivitajiet tas- soltu, nervi, • bidliet fit- togħma • disturb fil- qalb (attakk tal- qalb, rata tal- qalb mgħaġġla aktar min- normal, rata tal- qalb imnaqqsa, rata tal- qalb irregolari, uġigħ fis- sider) • infjammazzjoni, irritazzjoni u/ jew tgħafis fil- pulmun, ażżma, qtugħ ta ’ nifs • tkabbir ta ’ l- addome • uġigħ fis- sit ta ’ l- infużjoni
71 b) If you are being treated for rheumatoid arthritis Some other less frequent effects might occur, including: pain in the tummy, back, chest, muscles and/or joints, at the infusion site (where the drip is put into your vein), feeling unwell, changes in blood pressure, changes in heart rate, diarrhoea, indigestion, cramp, dizziness, tingling or numbness, anxiety or nervousness, cough, watery or itchy eyes, runny or itchy nose, sweating, sinusitis.
b) Jekk qed tiġi kkurat/ a għall- artrite rewmatika Jista ’ jkun hemm xi effetti oħra inqas frekwenti, fosthom: uġigħ fiż- żaqq, fid- dahar, fis- sider, fil - muskoli u/ jew fil- ġogi, fis- sit ta ’ l- infużjoni (il- post fejn jiddaħħal id- dripp fil- vina tiegħek), tħossok ma tiflaħx, bidliet fil- pressjoni tad- demm, bidliet fir- ritmu tal- qalb, dijarea, indiġestjoni, bugħawwieġ, sturdament, tnemnim jew tirżiħ, ansjetà jew nervożità, sogħla, għajnejk idemmgħu jew jekluk, imnieħer iqattar jew jieklok, għaraq, sinożite.
Some patients also have some changes to blood tests including a fall in the number of red cells, white cells or both.
Xi pazjenti jkollhom ukoll bidliet fit- testijiet tad- demm fosthom tnaqqis fiċ- ċelluli ħomor, fiċ- ċelluli bojod jew fit- tnejn.
If you are receiving MabThera in combination with other medicines, some of the side effects you may experience may be due to the other medicine.
Jekk qed tirċievi MabThera flimkien ma ’ mediċini oħra, xi wħud mill- effetti sekondarji li tista ’ tħoss jistgħu jkunu minħabba l- mediċina l- oħra.
If any of the side effects gets serious, or, if you notice any side effects not listed in this leaflet, please inform your doctor, nurse or pharmacist (chemist) immediately.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib, lin- ners jew lill- ispiżjar tiegħek immedjatament.
HOW TO STORE MABTHERA
KIF TAĦŻEN MABTHERA
Do not use MabThera after the expiry date which is stated on the carton after EXP.
Tużax MabThera wara d- data ta ’ skadenza li tidher fuq il- kartuna wara EXP.
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.
What Mab Thera contains
X’ fih MabThera
- The active ingredient in MabThera is called rituximab.
- Is- sustanza attiva f’ MabThera hija msejħa rituximab.
The vial contains 100 mg of Rituximab
Il- kunjett fih 100 mg ta ’ Rituximab
(10 mg/ml).
(10mg/ ml).
- The other ingredients are sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide,
- Is- sustanzi l- oħra huma sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide,
hydrochloric acid and water for injections.
hydrochloric acid u ilma għall- injezzjonijiet.
What MabThera looks like and contents of the pack
Id- dehra ta ’ MabThera u l- kontenuti tal- pakkett
MabThera is a clear, colourless solution, supplied as a concentrate for solution for infusion.
MabThera huwa soluzzjoni ċara, bla kulur, li tiġi fornuta bħala konċentrat għal soluzzjoni għal infużjoni.
Vials of 10 ml are available as a pack of 2 vials.
Il- kunjetti ta ’ 10 ml huma disponibbli bħala pakkett ta ’ 2 kunjetti.
Marketing Authorisation Holder and Manufacturer
76 Id- Detentur ta ’ l- Awtorizzazzjoni għat - tqegħid fis- Suq u l- Manifattur:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwardin il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Malta (See United Kingdom)
Malta (Ara Renju Unit)
Slovenská republika Roche Slovensko, s.r.o.
77 Slovenská republika Ísland Roche Slovensko, s. r. o.
MabThera 500 mg concentrate for solution for infusion rituximab
MabThera 500 mg konċentrat għal soluzzjoni għal infużjoni rituximab
B lymphocytes are involved in the cause of some of the symptoms you have.
Il - limfoċiti B huma involuti fil- kawża ta ’ xi wħud mis- sintomi li jista ’ jkollok.
2.
79 2.
75 Do not take MabThera
Tieħux MabThera
- if you are allergic to rituximab, to other similar proteins, or to any of the other ingredients in the
- jekk int allerġiku/ a għal rituximab, proteini oħra simili, jew għal xi sustanzi oħra fis- soluzzjoni.
Driving and using machines It is not known whether MabThera has an effect on your ability to drive a car or use machines.
80 Sewqan u tħaddim ta ’ magni Mhux magħruf jekk MabThera għandux effett fuq il- ħila tiegħek li ssuq karozza jew tħaddem magni.
a) If you are being treated for non-Hodgkin’s Lymphoma If you are treated with MabThera alone you will receive infusions at weekly intervals for a total of four infusions (days 1, 8, 15 and 22), so that the a course of treatment usually lasts for 22 days.
a) Jekk qed tiġi kkurat/ a għal Limfoma mhux ta ’ Hodgkin Jekk qed tiġi kkurat b’ MabThera waħdu, inti se tirċievi infużjonijiet f’ intervalli ta ’ ġimgħa għal total ta ’ erba ’ infużjonijiet (ġurnata 1, 8, 15 u 22), sabiex kors ta ’ kura ġeneralment idum 22 jum.
Infections Tell your doctor after your MabThera treatment if you get any symptoms of an infection, for example fever, cough, sore throat, burning pain when passing urine, or you start to feel weak or generally unwell.
Infezzjonijiet Għid lit- tabib tiegħek wara l- kura tiegħek b’ MabThera jekk tħoss xi sintomi ta ’ infezzjoni, pereżempju deni, sogħla, griżmejk juġgħuk, ħruq li jweġġa ’ meta tagħmel l- awrina, jew tibda tħossok dgħajjef jew ma tiflaħx b’ mod ġenerali.
You might get infections more easily following MabThera therapy.
Inti jistgħu jaqbduk infezzjonijiet aktar faċilment wara terapija
77 Very rarely, some patients taking MabThera have had a serious brain infection, which has been fatal.
Rari ħafna, xi pazjenti li kienu qed jieħdu MabThera kellhom infezzjonijiet serji f’ moħħom li kienu fatali.
Other reactions a) If you are being treated for non-Hodgkin’s Lymphoma or chronic lymphocytic leukaemia The most commonly reported side effects due to MabThera (reported in more than 1 out of 10 patients are: • infections such as pneumonia (bacterial) and herpes (viral) or bronchial tube inflammation (bronchitis) • low number of white blood cells, with or without fever • allergic reactions after infusion • nausea • skin rashes, itching ,bald spots on the scalp fever, chills, physical weakness, headache • decreased immunity (decreased IgG levels)
Reazzjonijiet oħra a) Jekk qed tiġi kkurat għal Limfoma mhux ta ’ Hodgkin jew lewkimja limfoċitika kronika L- effetti sekondarji irrapportati b’ mod l- aktar komuni kkawżati minn MabThera (irrapportati f’ aktar minn pazjent wieħed minn kull 10) huma: • infezzjonijiet bħal pnewmonja (ikkawżata minn batterja) u herpes (ikkawżata minn virus) jew infjammazzjoni tat- tubu tal- bronki, bronkite • numru baxx ta ’ ċelluli bojod tad- demm, bid- deni jew bla deni • reazzjonijiet allerġiċi wara infużjoni • tqalligħ
Uncommon side effects due to MabThera (reported in more than 1 out of 1000 patients) include: • abnormal clotting, decrease of blood cells production, autoimmune decrease of red blood cells, swollen/enlarged lymph nodes • low mood and loss of interest or pleasure in usual activities, nervousness • taste changes • heart disorder (heart attack, abnormally fast heart rate, reduced heart rate, irregular heart rate, chest pain) • inflammation, irritation and/or tightness of the lungs, asthma, shortness of breath • enlargement of the abdomen • pain at the infusion site
82 Effetti sekondarji mhux komuni kkawżati minn MabThera (irrapportati f’ aktar minn pazjent wieħed minn kull 1000) jinkludu: • tgħaqid mhux normali tad- demm, tnaqqis fil- produzzjoni ta ’ ċelluli tad- demm, tnaqqis awto - immuni ta ’ ċelluli ħomor tad- demm, glandoli tal- limfa minfuħa/ akbar mis- soltu • burdata depressa u nuqqas ta ’ interess jew pjaċir fl- attivitajiet tas- soltu, nervi, • bidliet fit- togħma • disturb fil- qalb (attakk tal- qalb, rata tal- qalb mgħaġġla aktar min- normal, rata tal- qalb imnaqqsa, rata tal- qalb irregolari, uġigħ fis- sider) • infjammazzjoni, irritazzjoni u/ jew tgħafis fil- pulmun, ażżma, qtugħ ta ’ nifs • tkabbir ta ’ l- addome • uġigħ fis- sit ta ’ l- infużjoni
78 b) If you are being treated for rheumatoid arthritis Some other less frequent effects might occur, including: pain in the tummy, back, chest, muscles and/or joints, at the infusion site (where the drip is put into your vein), feeling unwell, changes in blood pressure, changes in heart rate, diarrhoea, indigestion, cramp, dizziness, tingling or numbness, anxiety or nervousness, cough, watery or itchy eyes, runny or itchy nose, sweating, sinusitis.
b) Jekk qed tiġi kkurat/ a għall- artrite rewmatika Jista ’ jkun hemm xi effetti oħra inqas frekwenti, fosthom: uġigħ fiż- żaqq, fid- dahar, fis- sider, fil - muskoli u/ jew fil- ġogi, fis- sit ta ’ l- infużjoni (il- post fejn jiddaħħal id- dripp fil- vina tiegħek), tħossok ma tiflaħx, bidliet fil- pressjoni tad- demm, bidliet fir- ritmu tal- qalb, dijarea, indiġestjoni, bugħawwieġ, sturdament, tnemnim jew tirżiħ, ansjetà jew nervożità, sogħla, għajnejk idemmgħu jew jekluk, imnieħer iqattar jew jieklok, għaraq, sinożite.
The vial contains 500 mg of Rituximab
Il- kunjett fih 500 mg ta ’ Rituximab
What Mab Thera looks like and contents of the pack
Id- dehra ta ’ MabThera u l- kontenuti tal- pakkett
The pack contains one 50 ml vial.
Il- pakkett fih kunjett ta ’ 50 ml wieħed.
Marketing Authorisation Holder and Manufacturer
83 Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur:
1 D-79639 Grenzach-Wyhlen
1 D- 79639 Grenzach- Wyhlen Il- Ġermanja
Ísland Roche a/s c/o Icepharma hf Sími: +354 540 8000
Roche a/ s c/ o Icepharma hf Sími: +354 540 8000
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 DWAR L- UŻU SIGUR U EFFETTIV TAL - PRODOTTI MEDIĊINALI LI JRIDU JIĠU IMPLIMENTATI MILL- ISTATI MEMBRI
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 KUNDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR L- UŻU SIGUR U EFFETTIV TAL- PRODOTTI MEDIĊINALI LLI JRIDU JIĠU IMPLIMENTATI MILL- ISTATI MEMBRI
The Member States must ensure that the education plans for physicians, health care providers, and patients contain the measures a) to m) as detailed below, and are suitable for the purpose of minimising adverse events associated with the intravitreal injection procedure (e. g. endophthalmitis) prior to marketing.
L- Istati Membri jridu jiżguraw li l- pjanijiet ta ’ l- edukazzjoni għat- tobba, għal dawk involuti fil- kura tas- saħħa, u għall- pazjenti jkun fihom il- miżuri a) sa m) kif imsemmi hawn taħt, u huma xierqa għall - iskop tat- tnaqqis ta ’ l- episodji sekondarji assoċjati mal- proċedura ta ’ l- injezzjoni intravitreali (eż. l - endoftalmite) qabel it- tqegħid fis- suq.
An educational plan for physicians and health care providers which is aimed at risk minimisation and to support safe and effective use for the product.
Pjan edukattiv għat- tobba u għal dawk involuti fil- kura tas- saħħa li jkun immirat għat- tnaqqis tar- riskji u għall- appoġġ ta ’ l- użu sigur u effettiv tal- prodott.
This pl an shall consist of measures aiming to minimise adverse events associated with the intravitreal injection procedure (e.g. endophthalmitis) through adequate education about:
Il- pjan irid ikun jikkonsisti minn miżuri immirati għat- tnaqqis ta ’ episodji sekondarji assoċjati mal- proċedura ta ’ l- injezzjoni intravitreali (eż. l- endoftalmite) permezz ta ’ edukazzjoni xierqa dwar:
b) Sterile techniques to minimize risk of infection c) Use of antibiotics d) Use of povidone iodine e) Performing lid scrubs f) Use of anesthetic to ensure patient comfort g) Techniques for the intravitreal injection h) Management of intraocular pressure (IOP) i) Management of endophthalmitis j) Understanding the risk factors involved in developing endophthalmitis k) Reporting of serious adverse events • An educational plan for patients which is aimed at risk minimisation and to support safe and effective use for the product.
a) Il- proċedura intravitreali kif imwettqa fl- istudji kliniċi kruċjali b) Tekniċi sterili għat- tnaqqis tar- riskju ta ’ l- infezzjoni c) L- użu ta ’ l- antibijotiċi d) L- użu ta ’ povidone iodine e) It- tindif metikoluż tal- għotjien f) L- użu ta ’ anestetiku biex tkun żgurata l- kumdità tal- pazjent g) Proċeduri għall- injezzjoni intravitreali h) Il- ġestjoni tal- pressjoni ta ’ ġol- għajn (IOP) i) Il- ġestjoni ta ’ l- endoftalmite j) Spjegazzjoni tal- fatturi tar- riskju involuti fl- iżvilupp ta ’ l- endoftalmite k) Ir- rappurtaġġ ta ’ episodji sekondarji serji • Pjan edukattiv għall- pazjenti li jkun immirat għat- tnaqqis tar- riskji u għall- appoġġ ta ’ l- użu sigur u effettiv għall- prodott.
This plan shall consist of measures to provide adequate education on: l) Key signs and symptoms of serious adverse events associated with the intravitreal injection procedure m) When to seek urgent attention from the health care provider
Il- pjan irid jinkludi miżuri biex tingħata edukazzjoni xierqa dwar: l) Sinjali u sintomi ta ’ episodji sekondarji serji assoċjati mal- proċeduri ta ’ l- injezzjoni intravitreali m) Meta jkun hemm bżonn li tinkiseb attenzjoni urġenti minn dawk involuti fil- kura tas- saħħa
Its purpose is to explain how the assessment done by the Committee for Medicinal products for Human Use (CHMP) on the basis of the studies performed, led to the recommendations on the conditions of use.
Jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqin, biex jissodisfa r- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk teħtieġ iktar tagħrif dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (li hu wkoll parti mill- EPAR) jew kellem lit- tabib jew lill- ispiżjar tiegħek Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR.
What is Macugen?
X’ inhu Macugen?
Macugen is a solution for intraocular injection (injection into the eye).
Macugen huwa soluzzjoni għal injezzjoni intraokulari (injezzjoni fil- għajn).
It is given by an ophthalmologist (eye specialist) who is skilled at this type of injection.
Jingħata minn oftalmologu (speċjalista tal- għajnejn) li jkun imħarreġ f’ din it- tip ta ’ injezzjoni.
Macugen contains the active ingredient pegaptanib sodium.
Macugen fih is- sustanza attiva pegaptanib sodium.
What is Macugen used for?
Għal xiex jintuża Macugen?
Macugen is used to treat patients with the wet form of age-related macular degeneration (AMD).
Macugen jintuża fit- trattament ta ’ pazjenti li jsofru mill- forma umda tad- deġenerazzjoni makulari relatata ma ’ l- età (AMD).
This disease affects the central part of the retina (called the macula), at the back of the eye and causes loss of vision.
Din il- marda taffettwa l- parti ċentrali tar- retina (magħrufa bħala l- makula), fuq wara tal- għajn u tikkawża telf fil- viżta.
The macula provides central vision that is needed for driving a car, reading fine print, and other similar tasks.
Il- makula tipprovdi l- viżjoni ċentrali meħtieġa għas- sewqan ta ’ karozza, il- qari ta ’ kitba rqiqa, u funzjonijiet simili.
The wet form of the disease is caused by abnormal blood vessels under the retina and the macula, which may bleed and leak fluid.
Il- forma umda ta ’ din il- marda hija kkawżata minn arterji u vini anormali taħt ir- retina u l- makula, li minnhom jista ’ joħroġ id- demm jew fluwidu.
This causes the loss of vision.
Dan iwassal għal telf fil- viżta.
AMD is rare in people under 55 years of age.
L- AMD hija rari f’ persuni ta ’ taħt il- 55 sena.
It is more common in people 75 years of age or older (1 in 20 people of this age group are affected by AMD).
Hija iktar komuni f’ persuni ta ’ 75 sena jew iktar (1 minn kull 20 persuna f’ din il- kategorija huma affettwati mill- AMD).
How is Macugen used?
Kif jintuża Macugen?
Macugen is given as one injection into the affected eye every 6 weeks.
Macugen jingħata b’ injezzjoni waħda fil- għajn mogħtija kull 6 ġimgħat.
An ophthalmologist who is skilled at this type of injection should give Macugen.
Din għandha tingħata minn oftalmologu mħarreġ fl- għoti ta ’ din it- tip ta ’ injezzjoni.
Before each injection, a local anaesthetic will be given to reduce or prevent any pain from the injection.
Qabel kull injezzjoni, jingħata anestetiku lokali biex jipprevjeni jew inaqqas l- uġigħ ta ’ l- injezzjoni.
Antibiotic eye drops may also be given before and after the Macugen injection, to prevent eye infection.
Jista ’ jingħata qtar ta ’ l- antibijotiku qabel u wara l- injezzjoni ta ’ Macugen, għall- prevenzjoni ta ’ infezzjoni tal- għajn.
How does Macugen work?
Kif jaħdem Macugen?
Macugen blocks a substance called Vascular Endothelial Growth Factor which makes the blood vessels grow, and also causes fluid to leak from the vessels and swelling.
Macugen jimblokka sustanza magħrufa bħala Vascular Endothelial Growth Factor li jġiegħel lill - arterji u lill- vini jikbru, u jwassal ukoll għall- ħruġ ta ’ fluwidu mill- arterji u l- vini u nefħa.
All these effects are thought to worsen the disease.
Huwa maħsub li dawn il- miżuri kollha jagħmlu din il- marda agħar.
Macugen blocks this factor so there is less growth of these blood vessels, and less bleeding and leakage.
Macugen jimblokka dan il- fattur u għalhekk ikun hemm inqas tkabbir ta ’ dawn l- arterji u vini, u inqas telf ta ’ demm u fluwidu.
How has Macugen been studied?
Kif ġie studjat Macugen?
Macugen has been investigated in two main clinical studies.
Macugen ġie investigat f’ żewġ studji kliniċi ewlenin.
The studies included 1190 patients and lasted up to two years.
Fl- istudji ħadu sehem 1190 pazjent u dawn damu sejrin sa sentejn.
The safety and efficacy of three different doses of Macugen were studied (0.3 mg, 1 mg and 3 mg).
Ġew studjati s- sigurtà u l- effikaċja ta ’ tliet dożi differenti ta ’ Macugen (0. 3 mg,