qanastek/EMEA-V3 huggingface dataset:
Do not stop taking your medicine unless your doctor tells you to.
Tieqafx tieħu il- mediċina tiegħek sakemm ma jgħidlekx tagħmel hekk it- tabib tiegħek.
If you have any further questions on the use of this product, ask your doctor.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib tiegħek.
Like all medicines, CellCept can have side effects, although not everybody gets them.
Bħall- kull mediċina oħra, CellCept jista 'jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Some of the more usual problems are diarrhoea, fewer white cells and/ or red cells in your blood, infection and vomiting.
Uħud mill- aktar problemi komuni huma dijarea, tnaqqis fiċ- ċelloli bojod u/ jew ċelloli ħomor tad- demm tiegħek, infezzjonijiet u rimettar.
Your doctor will do regular blood tests to monitor any changes in the number of your blood cells or changes in the levels of any of the substances carried in your blood, e. g. sugar, fat, cholesterol.
It- tabib tiegħek se jagħmel testijiet regolari tad- demm, biex jissorvelja xi tibdil fin- numru ta ’ ċelloli tad- demm tiegħek jew bidliet fil- livelli ta 'xi sustanzi li jinġarru fid- demm tiegħek, e. ż. zokkor, xaħam, kolesterol.
Children may be more likely than adults to have side effects such as diarrhoea, infections, fewer white cells and fewer red cells in the blood.
It- tfal jistgħu jkunu f' riskju akbar mill- adulti li jkollhom effetti sekondarji bħal dijarea, infezzjonijiet, anqas ċelloli bojod u anqas ċelloli ħomor fid- demm.
CellCept reduces your body’ s own defence mechanisms to stop you rejecting your transplanted kidney, heart or liver.
CellCept inaqqas il- mekkaniżmi ta ’ difiża tal- ġisem tiegħek stess biex iwaqqfek milli tiċħad l- kliewi, l - qalb jew il- fwied trapjantati.
Consequently your body will not be as good as normal at fighting infections.
Minħabba dan ġismek ma jkunx tajjeb daqs s- soltu biex jiġġieled l - infezzjonijiet.
So if you are taking CellCept you may therefore catch more infections than usual, such as infections of the brain, skin, mouth, stomach and intestines, lungs and urinary tract.
Għalhekk jekk qed tieħu CellCept tista ’ tieħu aktar infezzjonijiet mis- soltu, bħal infezzjonijiet fil- moħħ, fil- ġilda, fil- ħalq, fl- istonku, fl- imsaren, fil- pulmuni u fil- passaġġ ta ’ l- awrina.
As can happen in patients taking this type of medicine, a very small number of CellCept patients have developed cancer of the lymphoid tissues and skin.
Bħal ma jista ’ jiġri f’ pazjenti li qed jieħdu din it- tip ta ’ mediċina, numru żgħir ta ’ pazjenti b’ CellCept żviluppaw kanċer tal- ġilda u tat- tessuti limfatiċi.
73 General unwanted effects affecting your body as a whole could include hypersensitivity (such as anaphylaxis, angioeodema), fever, lethargy, difficulty in sleeping, pains (such as abdominal, chest, joint/ muscle, pain on passing urine), headache, flu symptoms and swelling.
74 Effetti mhux mixtieqa ġenerali oħra li jistgħu jaffettwaw lill- ġismek kollu jistgħu jinkludu sensittività eċċessiva (bħal anafilassi, anġio- edima) deni, għeja, diffikultà biex torqod, uġigħ (bħal uġigħ addominali, fis- sider, fil- ġogi/ muskoli, uġigħ waqt li qed tgħaddi l- awrina), uġigħ ta 'ras, sintomi ta' riħ, u nefħa.
Other unwanted effects may include:
Effetti oħra mhux mixtieqa jistgħu jinkludu:
Disorders of the skin such as acne, cold sores, shingles, skin growth, hair loss, rash, itching.
Disturbi fil- ġilda bħal akne, bżieżaq tar- riħ, ħruq ta 'Sant' Antnin, tkabbir tal- ġilda, telf ta ’ xagħar, raxx, u ħakk.
Urinary disorders such as kidney problems or the urgent need to pass urine.
Disturbi fis- sistema urinarja bħal problemi tal- kliewi jew tħoss urġenza biex tgħaddi l- awrina.
Disorders of the digestive system and mouth such as constipation, nausea, indigestion, pancreas inflammation, intestinal disorders including bleeding, inflammation of the stomach, liver problems, inflammation of the colon, loss of appetite, flatulence and mouth ulcers.
Disturbi fis- sistema diġestiva u fil- ħalq bħal stitikezza, tqalligħ, indiġestjoni, infjammazzjoni tal- frixa, disturbi intestinali inkluż fsada, infjammazzjoni ta ’ l- istonku, problemi tal- fwied, infjammazzjoni tal - kolon, nuqqas ta 'aptit, gass u ulċeri fil- ħalq.
Disorders of the nerves and senses such as convulsions, tremor, dizziness, depression, drowsiness, numbness, muscle spasms, anxiety, changes in thinking or mood.
Disturbi tan- nervituri u tas- sensi bħal aċċessjonijiet, tregħid, sturdament, depressjoni, għeja, tnemnim, spażmi tal- muskoli, ansjetà, bidla fil- ħsieb jew burdata.
Metabolic, blood and vascular disorders such as weight loss, gout, high blood sugar, bleeding, clots and bruises, change in blood pressure, abnormal heart beat and dilation of blood vessels may be seen.
Disturbi fil- metaboliżmu, tad- demm, u vaskulari bħal telf ta 'piż, gotta, livell ta' zokkor għoli fid- demm, fsada, demm magħqud u tbenġil, bidla fil- pressjoni tad- demm, taħbit tal- qalb mhux normali, u twessiegħ ta 'l- arterji u l- vini tad- demm.
Disorders of the lungs such as pneumonia, bronchitis, shortness of breath, cough, fluid on the lungs/ chest cavity, sinus problems.
Disturbi fil- pulmun bħal pnewmonja, bronkite, qtugħ ta 'nifs, sogħla, ilma fil- pulmun/ spazju tas- sider u problemi tas- sinus.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet whilst you are taking CellCept, please tell your doctor or pharmacist.
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 jew lill- ispiżjar tiegħek.
However, do not stop taking your medicine unless you have discussed this with your doctor first.
Madankollu, tieqafx tieħu il- mediċina tiegħek sakemm l- ewwel ma tkunx iddiskutejt dan mat- tabib tiegħek.
HOW TO STORE CELLCEPT
KIF TAĦŻEN CELLCEPT
Do not use the capsules after the expiry date stated on the carton (EXP).
M’ għandekx tuża l- kapsuli wara id- data ta ’ skadenza li tidher fuq il- kartuna wara JIS.
What CellCept contains
X’ fih CellCept
- The active substance is mycophenolate mofetil.
- Is- sustanza attiva hi mycophenolate mofetil.
CellCept capsules: pregelatinised maize starch croscarmellose sodium polyvidone (K-90) magnesium stearate
Kapsuli CellCept: pregelatinised maize starch croscarmellose sodium
74 Capsule shells: gelatin indigo carmine (E132) yellow iron oxide (E172) red iron oxide (E172) titanium dioxide (E171) black iron oxide (E172) potassium hydroxide shellac.
Il- qoxra tal- kapsula: gelatin, indigo carmine (E132) iron oxide isfar (E172) iron oxide aħmar (E172) titanium dioxide (E171) iron oxide iswed (E172) potassium hydroxide shellac.
What CellCept looks like and contents of the pack
Id- Dehra ta ’ CellCept u l- kontenuti tal- pakkett:
1 carton contains 100 capsules (in blister packs of 10) 1 carton contains 300 capsules (in blister packs of 10)
CellCept 250 mg kapsuli: kartuna 1 fiha 100 kapsula (f’ paketti ta ’ folji ta ’ 10) kartuna 1 fiha 300 kapsula (f’ paketti ta ’ folji ta ’ 10)
CellCept capsules are oblong, blue/ brown, branded with black "CellCept 250" on the capsule cap and "Company logo" on the capsule body.
Kapsuli iebsa Kapsuli CellCept: ublung, blu/ kannella, ttimbrati b’ tipa sewda b ’ "CellCept 250" fuq l- għatu tal- kapsula u bil - “ logo tal- Kumpanija ” fuq il- parti l- oħra tal- kapsula
Marketing Authorisation Holder
Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq
Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
Roche Registration Ltd 40 Broadwater Road Welwyn Garden City Hertfordshire AL7 3AY Ir- Renju Unit
Manufacturing Authorisation holder responsible for batch release Roche Pharma AG, Emil Barell Str.
Il- Manifattur Awtorizzat responsabbli għall- ħruġ tal- lott Roche Pharma AG, Emil Barell Str.
1, 79639 Grenzach Wyhlen, Germany.
1, 79639 Grenzach Wyhlen, Il- Ġermanja.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Deutschland Roche Pharma AG Tel: +49 (0) 7624 140
76 Deutschland Roche Pharma AG Tel: +49 (0) 7624 140
This leaflet was last approved in {MM/ YYYY}
Dan il- fuljett kien approvat l- aħħar f ’ [data]
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/. >.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
76 PACKAGE LEAFLET:
77 FULJETT TA 'TAGĦRIF:
CellCept 500 mg powder for concentrate for solution for infusion mycophenolate mofetil
CellCept 500 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni mycophenolate mofetil
Before you use CellCept 3.
Qabel ma ’ tuża CellCept 3.
How to use CellCept 4.
Kif għandek tuża CellCept 4.
Further information
Aktar Tagħrif
CellCept 500 mg powder for concentrate for solution for infusion is used to prevent your body rejecting a transplanted kidney or liver.
CellCept trab għall- konċentrat għal soluzzjoni għall- infużjoni jintuża biex ma jħallix il- ġisem tiegħek jiċħad kilwa, jew fwied trapjantati.
CellCept 500 mg powder for concentrate for solution for infusion is used together with other medicines known as ciclosporin and corticosteroids.
CellCept trab għall- konċentrat għal soluzzjoni għall- infużjoni jintuża flimkien ma 'mediċini oħra magħrufa bħala ciclosporin u kortikosterojdi.
BEFORE YOU USE CELLCEPT
QABEL MA ’ TIEĦU CELLCEPT
CellCept should not be given to you:
CellCept m’ għandux jingħatalek:
- If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid, polysorbate
- Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal mycophenolate mofetil, mycophenolic
80 or any of the other ingredients of CellCept.
acid, polysorbate 80 jew sustanzi oħra ta 'CellCept.
Tell your doctor if this applies to you.
Għid lit- tabib tiegħek jekk dan japplika għalik.
Therefore you should limit your exposure to sunlight and UV light by wearing appropriate protective clothing and using a sunscreen with high protection factor.
Għalhekk għandek tillimita l- esponiment tiegħek għax- xemx u għar- raġġi UV billi tilbes ħwejjeġ protettivi xierqa u bl- użu ta ’ sunscreen b’ fattur protettiv għoli.
77 Taking other medicines:
78 Meta tieħu mediċini oħra:
If you answer yes to any of the following questions talk to your doctor before you start to take CellCept:
Jekk twieġeb iva għal xi waħda minn dawn il- mistoqsijiet li ġejjin, kellem lit- tabib qabel ma tibda tieħu CellCept:
(which are sometimes given to patients after a transplant operation), cholestyramine (used to treat patients with high blood cholesterol), rifampicin (antibiotic), phosphate binders (used in patients with chronic renal failure to reduce the absorption of phosphate) or any other medicines (including those you can buy without a prescription) that your doctor does not know about?
jingħataw lill- pazjenti wara operazzjoni ta ’ trapjant), cholestyramine (użat biex jikkura pazjenti b’ kolesterol fid- demm għoli), rifampicin (antibijotiku), antaċidi, phosphate binders (użati f’ pazjenti b’ insuffiċjenza renali kronika biex inaqqsu l- assorbiment tal- fosfat) jew xi mediċini oħra (anki dawk mingħajr riċetta) li t- tabib tiegħek ma jafx dwarhom?
Pregnancy and breast feeding:
Tqala u Treddigħ:
Do not take CellCept if you are breastfeeding.
Tieħux CellCept jekk qed tredda ’.
You must not use CellCept during pregnancy unless clearly indicated by your doctor.
M’ għandekx tuża CellCept waqt it- tqala sakemm mhux indikat b’ mod ċar mit- tabib tiegħek.
Your doctor should advise you about using contraception before treatment with CellCept is started, during treatment with CellCept, and for 6 weeks after you have stopped treatment with CellCept.
It- tabib tiegħek għandu jagħtik parir dwar l- użu ta ’ kontraċettivi qabel ma tinbeda kura b’ CellCept, waqt il- kura b’ CellCept u għal 6 ġimgħat wara li twaqqaf il- kura b’ CellCept.
HOW TO USE CELLCEPT
KIF GĦANDEK TUŻA CELLCEPT
You will be given the intravenous infusion solution as your doctor has prescribed.
Se tingħata s- soluzzjoni għall- infużjoni fil- vini kif preskritt mit- tabib tiegħek.
The usual way to administer CellCept is as follows:
Ġeneralment CellCept jingħata kif ġej:
The first dose should be given within 24 hours after the transplant operation.
L- ewwel doża għandha tingħata fi żmien 24 siegħa wara li jkun sar it- trapjant.
The recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose).
Id- doża rakkomandata f’ pazjenti bi trapjanti tal- kliewi hija ta ’ 1 g mogħtija darbtejn kuljum (doża ta ’ 2 g kuljum).
The first dose of IV CellCept will be given as soon as possible following the transplant operation and will be continued for at least 4 days.
L- ewwel doża ta 'CellCept IV se tingħata mill- iktar fis possibbli wara li tkun saret l- operazzjoni tat - trapjant u se titkompla għal mill- inqas erbat ijiem.
The recommended daily dose of CellCept 500 mg powder for concentrate for solution for infusion in liver transplant patients is 1 g administered twice daily (2 g daily dose).
Id- doża rakkomandata ta ’ kuljum ta ’ CellCept 500 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni f’ pazjenti bi trapjant tal- fwied hija ta ’ 1 g mogħtija darbtejn kuljum (doża ta ’ 2g kuljum).
Oral administration of CellCept will be initiated as soon as you can tolerate oral medication.
Amministrazzjoni ta ’ CellCept orali se tinbeda hekk kif int tkun tista ’ tittollera mediċina mill- ħalq.
The recommended dose of oral CellCept in liver transplant patients is 1.5 g administered twice daily (3 g daily dose).
Id- doża rakkomandata ta ’ CellCept mill- ħalq f ’ pazjenti bi trapjant renali hija ta ’ 1. 5g mogħtija darbtejn kuljum (doża ta ’ kuljum ta ’ 3g).
The content of CellCept 500 mg powder for concentrate for solution for infusion vials must be reconstituted with 14 ml of glucose intravenous infusion 5% each.
Il- kontenut tal- kunjetti ta ’ CellCept 500 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni
A further dilution with glucose 78 intravenous infusion 5% is required to a final concentration of 6 mg/ ml.
79 għandhom jiġu rikostitwiti b’ 14 ml ta ’ infużjoni għal ġol- vini ta ’ 5% glukosju kull wieħed.
This means that to prepare a 1 g dose of mycophenolate mofetil the content of 2 reconstituted vials (approx.
Hija meħtieġa dilwazzjoni oħra ma ’ infużjoni għal ġol- vini ta ’ 5% glukosju għall- konċentrazzjoni finali ta ’ 6 mg/ ml.
2 x 15 ml) must be further diluted into 140 ml glucose intravenous infusion 5% solution.
Dan ifisser li biex tiġi ppreparata doża ta ’ 1g ta ’ mycophenolate mofetil il- kontent ta ’ żewġ kunjetti rikostitwiti (madwar 2 x 15 ml) għandhom jiġu dilwiti iżjed f’ 140 ml ta ’ infużjoni għal ġol- vini ta ’ 5% glukosju.
If the infusion solution is not prepared immediately prior to administration, the commencement of administration of the infusion solution should be within 3 hours from reconstitution and dilution of the medicinal product.
Jekk is- soluzzjoni għall- infużjoni ma tiġix ippreparata immedjatament qabel l- amministrazzjoni, l- bidu ta ’ l- amministrazzjoni tas- soluzzjoni għall- infużjoni għandu jkun sa 3 sigħat mir- rikostituzzjoni u dilwazzjoni tal- prodott mediċinali.
Avoid skin contact with prepared solutions.
Evita li s- soluzzjonijiet ippreparati jiġu f’ kuntatt mal- ġilda.
If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water.
Jekk iseħħ kuntatt, aħsel sew bis- sapun u l - ilma, laħlaħ l- għajnejn b’ ilma normali.
CellCept 500 mg powder for concentrate for solution for infusion must be given as intravenous infusion.
CellCept 500 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni għandu jingħata bħala infużjoni fil - vini.
The infusion flow rate should be controlled to equate a 2 hour period of administration.
Ir- rata ta ’ l- infużjoni għandha tiġi kkontrollata biex il- perjodu ta ’ l- amministrazzjoni iddum sagħtejn.
CellCept IV solution should never be administered by rapid or bolus intravenous injection.
Soluzzjoni ta ’ CellCept IV m’ għandha qatt tiġi amministrata permezz ta ’ injezzjoni ġol- vini malajr jew bolus.
As soon as you are able to tolerate oral medication your doctor will switch you to CellCept capsules, tablets or oral suspension.
Hekk kif tkun tista ’ titollera mediċina mill- ħalq it- tabib tiegħek se jaqilbek fuq kapsuli, pilloli jew suspensjoni orali ta ’ CellCept.
The duration of treatment will be decided by your doctor.
It- tul tal- kura se jiddeċidiħ it- tabib tiegħek.
If too much CellCept IV solution is given:
Jekk tingħata aktar CellCept IV milli suppost:
If you know that the dose of CellCept IV solution given to you exceeds the dose recommended by the doctor, seek medical advice immediately.
Jekk taf li d- doża ta ’ soluzzjoni ta ’ CellCept IV li ġiet mogħtija lilek hija iktar mid- doża rakkomandata mit- tabib, fittex parir mediku minnufih.
If a dose of CellCept is missed:
Jekk tinqabeż doża ta ’ CellCept:
If a dose of CellCept is missed, the dose should be administered as soon as possible.
Jekk tinqabeż doża ta ’ CellCept, id- doża għandha tiġi amministrata mill- iktar fis possibbli.
Further dosing should continue at the usual time.
Id- dożi l - oħrajn għandhom jitkomplew fil- ħin tas- soltu.
Effects when treatment with CellCept is stopped:
Effetti meta titwaqqaf il- kura b’ CellCept:
Do not stop using your medicine unless your doctor tells you to.
Tieqafx tuża il- mediċina tiegħek sakemm ma jgħidlekx tagħmel hekk it- tabib tiegħek.
POSSIBLE SIDE EFFECTS
X’ EFFETTI SEKONDARJI LI JISTA ’ JKOLLU
CellCept reduces your body’ s own defence mechanisms to stop you rejecting your transplanted kidney or liver.
CellCept inaqqas il- mekkaniżmi ta ’ difiża tal- ġisem tiegħek stess biex iwaqqfek milli tiċħad l- kliewi, jew il- fwied trapjantati.
Consequently your body will not be as good as normal at fighting infections.
Minħabba dan ġismek ma jkunx tajjeb daqs s- soltu biex jiġġieled l- infezzjonijiet.
People receiving CellCept 500 mg powder for concentrate for solution for infusion therefore catch more infections than usual, such as infections of the brain, skin, mouth, stomach and intestines, lungs and urinary tract.
Għalhekk nies li qed tieħdu CellCept 500 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni jaqbduhom aktar infezzjonijiet mis- soltu, bħal infezzjonijiet fil- moħħ, fil- ġilda, fil- ħalq, fl- istonku, fl - imsaren, fil- pulmuni u fil- passaġġ ta ’ l- awrina.
General unwanted effects affecting your body as a whole could include hypersensitivity (such as anaphylaxis, angioeodema), fever, lethargy, difficulty in sleeping, pains (such as abdominal, chest, joint/ muscle, pain on passing urine), headache, flu symptoms and swelling.
Effetti mhux mixtieqa ġenerali oħra li jistgħu jaffettwaw lill- ġismek kollu jistgħu jinkludu sensittività eċċessiva (bħal anafilassi, anġio- edima) deni, għeja, diffikultà biex torqod, uġigħ (bħal uġigħ addominali, fis- sider, fil- ġogi/ muskoli, uġigħ waqt li qed tgħaddi l- awrina), uġigħ ta 'ras, sintomi ta' riħ, u nefħa.
Other unwanted effects may include:
80 Effetti oħra mhux mixtieqa jistgħu jinkludu:
Disorders of the skin such as acne, cold sores, shingles, hair loss, rash, itching.
Disturbi fil- ġilda bħal akne, bżieżaq tar- riħ, ħruq ta 'Sant' Antnin, telf ta ’ xagħar, raxx, u ħakk.
79 Urinary disorders such as kidney problems or the urgent need to pass urine.
Disturbi fis- sistema urinarja bħal problemi tal- kliewi jew tħoss urġenza biex tgħaddi l- awrina.
Disorders of the nerves and senses such as convulsions, tremor, depression, drowsiness, numbness, muscle spasms, changes in thinking or mood.
Disturbi tan- nervituri u tas- sensi bħal aċċessjonijiet, tregħid, depressjoni, għeja, tnemnim, spażmi tal - muskoli, bidla fil- ħsieb jew burdata.
Metabolic, blood and vascular disorders such as dehydration, weight loss, high blood sugar, bleeding, clots and bruises, change in blood pressure and abnormal heart beat may be seen.
Disturbi fil- metaboliżmu, tad- demm, u vaskulari bħal deidrazzjoni, telf ta 'piż, livell ta' zokkor għoli fid- demm, fsada, demm magħqud u tbenġil, bidla fil- pressjoni tad- demm u taħbit tal- qalb mhux normali.
Other unwanted effects caused by the intravenous infusion include local inflammation of the veins.
Effetti oħra mhux mixtieqa ikkawżati mill- infużjoni fil- vini jinkludu infjammazzjoni lokali tal- vini.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet during your treatment with CellCept, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk waqt il- kura tiegħek b’ CellCept tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
Keep out of the reach and sight of children.
Żomm fejn ma ’ jintlaħaqx u ma ’ jidhirx mit- tfal żgħar.
Do not use the powder for solution for infusion after the expiry date stated on the carton and on the vials (EXP).
Tużax it- trab għall- konċentrat għal soluzzjoni għall- infużjoni wara id- data ta ’ skadenza li tidher fuq kartuna u l- kunjetti wara JIS.
Powder for concentrate for solution for infusion: do not store above 30 °C.
Trab għall- konċentrat għal soluzzjoni għall- infużjoni:
Reconstituted solution and the diluted solution: store at 15 – 30 °C.
Is- soluzzjoni rikostitwita u s- soluzzjoni dilwita: aħżen f’ temperatura ta ’ 15 - 30°C.
CellCept 500 mg powder for concentrate for solution for infusion:
CellCept 500 trab għall- konċentrat għal soluzzjoni għall- infużjoni:
Polysorbate 80 citric acid hydrochloric acid sodium chloride.
Polysorbate 80 citric acid hydrochloric acid sodium chloride.
What CellCept looks like and contents of the pack
81 Id- Dehra ta ’ CellCept u l- kontenuti tal- pakkett:
80 Powder for concentrate for solution for infusion:
Trab għall- konċentrat għal soluzzjoni għall- infużjoni:
CellCept 500 mg powder for concentrate for solution for infusion must be reconstituted and further diluted with glucose intravenous infusion 5% prior to administration to the patient.
CellCept 500 trab għall- konċentrat għal soluzzjoni għall- infużjoni għandu jiġi rikostitwit u dilwit aktar ma ’ infużjoni għal ġol- vini ta ’ 5% glukosju qabel l- amministrazzjoni lill- pazjent.
Eesti Roche Eesti OÜ Tel: + 372 - 6 177 380
Eesti Tel: + 372 - 6 177 380 Roche Eesti OÜ
España Roche Farma S. A.
82 España Roche Farma S. A.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/. >
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
82 PACKAGE LEAFLET:
83 FULJETT TA 'TAGĦRIF:
CellCept 1 g/ 5 ml powder for oral suspension mycophenolate mofetil
CellCept 1 g/ 5 ml trab għal suspensjoni orali mycophenolate mofetil
if their symptoms are the same as yours
ħsara, anki jekk ikollom l- istess sintomi bħall tiegħek.
CellCept 1 g/ 5 ml powder for oral suspension is used to prevent your body rejecting a transplanted kidney, heart or liver.
CellCept 1 g/ 5 ml trab għal suspensjoni orali jintuża biex ma jħallix il- ġisem tiegħek jiċħad kilwa, qalb jew fwied trapjantati.
CellCept 1 g/ 5 ml powder for oral suspension is used together with other medicines known as ciclosporin and corticosteroids.
CellCept 1 g/ 5 ml trab għal suspensjoni orali jintuża flimkien ma 'mediċini oħra magħrufa bħala ciclosporin u kortikosterojdi.
Do not take CellCept:
Tieħux CellCept:
- If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the
- Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal mycophenolate mofetil, mycophenolic
other ingredients of CellCept.
acid, jew sustanzi oħra ta 'CellCept.
- In case of any evidence of infection (e. g. fever, sore throat), unexpected bruising and/ or
- F’ każ ta ’ evidenza ta ’ infezzjoni (e. ż. deni, uġigħ fil- griżmejn), tbenġil u/ jew fsada bla spjegazzjoni.
- If you have or ever have had any problems with your digestive system, e. g. stomach ulcers.
- Jekk għandek jew qatt kellek xi problemi bis- sistema diġestiva tiegħek e. ż., ulċeri fl- istonku.
- If you suffer from phenylketonuria (a rare, hereditary disorder of the metabolism).
- Jekk issofri minn phenylketonuria (marda tal- metaboliżmu eridetarja, rari).
83 Taking other medicines:
84 Meta tieħu mediċini oħra:
Your doctor should advise you about using contraception before taking CellCept, whilst taking CellCept, and for six weeks after you have stopped taking CellCept.
It- tabib tiegħek għandu jagħtik parir dwar l- użu ta ’ kontraċettivi qabel ma tieħu CellCept, waqt li qed tieħu CellCept u għal 6 ġimgħat wara li tieqaf tieħu CellCept.
Important information about some of the ingredients of CellCept 1 g/ 5 ml powder for oral suspension:
Tagħrif importanti dwar xi sustanzi ta ’ CellCept 1 g/ 5 ml trab għal suspensjoni orali:
If you suffer from phenylketonuria (a rare, hereditary disorder of the metabolism), talk to your doctor before you start to take this medicine.
Jekk tbagħti minn Phenylketonuria (marda tal - metaboliżmu eridetarja, rari) kellem lit- tabib tiegħek qabel ma tibda tieħu din il- mediċina.
This medicine also contains sorbitol which is a sugar.
Din il- mediċina fiha wkoll sorbitol li huwa zokkor.
If you have been told by your doctor that you have an intolerance to some sugars, such as sorbitol, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi zokkrijiet, bħal sorbitol, kellem lit- tabib tiegħek qabel tieħu dan il- prodott mediċinali.
The usual way to take CellCept oral suspension is as follows:
Il- doża tas- ssoltu ta ’ CellCept suspensjoni orali hija:
The recommended daily dose is 10 ml suspension (2 g of the active ingredient) taken as 2 separate doses.
Id- doża rakkomandata ta ’ kuljum hija ta ’ 10 ml ta ’ suspensjoni (2 g tas- sustanza attiva) li tittieħed bħala żewġ dożi separati.
This means taking 5 ml suspension in the morning and then 5 ml suspension in the evening.
Dan ifisser 5 ml ta ’ suspensjoni filgħodu u 5 ml ta ’ suspensjoni filgħaxija.
84 The dose given will vary depending on the size of the child.
Id- doża mogħtija tvarja skond id- daqs tat- tifel/ tifla.
The recommended dose is 600 mg/ m² taken twice a day.
Id- doża rakkomandata hija 600 mg/ m² li tittieħed darbtejn
The recommended daily dose is 15 ml suspension (3 g of the active ingredient) taken as 2 separate doses.
Id- doża rakkomandata ta ’ kuljum hija 15 ml ta ’ suspensjoni (3 g tas- sustanza attiva) li titieħed bħala żewġ dożi separati.
This means taking 7.5 ml suspension in the morning then 7.5 ml suspension in the evening.
Dan ifisser li trid tieħu 7. 5 ml ta ’ suspensjoni filgħodu u wara 7. 5 ml ta ’ suspensjoni filgħaxija.
No data are available to recommend the use of CellCept in children who have received a heart transplant.
M’ hemm l- ebda tagħrif disponibli biex jiġi rakkomandat l- użu ta ’ CellCept fi tfal li rċevew trapjant tal - qalb.
The recommended daily dose is 15 ml suspension (3 g of the active ingredient) taken as 2 separate doses.
Id- doża rakkomandata ta ’ kuljum hija ta ’ 15 ml ta ’ suspensjoni kuljum (3g tas- sustanza attiva) li tittieħed bħala żewġ dożi separati.
It is recommended that the pharmacist reconstitutes CellCept oral suspension for you prior to dispensing.
Huwa rakkomandat li l- ispiżjar jirrikostitwixxi s- suspensjoni orali ta ’ CellCept qabel tingħatalek.
To reconstitute the suspension the pharmacist will proceed as follows:
Biex jirrikostitwixxi s- suspensjoni l- ispiżjar se jipproċedi kif ġej:
(The shelf-life of the reconstituted suspension is 2 months.)
(Is- suspensjoni rikostitwita iddum tajba għal xahrejn)
Avoid inhalation or direct contact with skin or mucous membranes of the dry powder as well as direct contact of the reconstituted suspension with the skin.
Evita li t- trab niexef kif ukoll is- suspensjoni rikostitwita jittieħdu man- nifs jew jiġu f’ kuntatt dirett mal - ġilda jew membrani mukużi.
85 To withdraw the suspension with the oral dispenser proceed as follows:
86 Biex ittella s- suspensjoni bid- dispenser orali pproċedi kif ġej:
Shake closed bottle well for about 5 seconds before each use.
Ħawwad il- flixkun magħluq għal madwar 5 sekondi qabel kull darba li tużah.
Remove child-resistant cap.
Neħħi l- għatu reżistenti għat- tfal tal- flixkun.
Before inserting the tip of the dispenser into bottle adapter, push the plunger completely down toward the tip of the dispenser.
Qabel ma ddaħħal il- ponta tad- dispenser fl- adattur tal- flixkun, imbotta il- planġer s’ isfel nett lejn it - tarf tad- dispenser.
Insert tip firmly into opening of the bottle adapter.
Daħħal it- tarf sewwa fil- ftuħ ta ’ l- adattur tal- flixkun.
Turn the entire unit (bottle and dispenser) upside down.
Dawwar kollox (il- flixkun u d- dispenser) ta ’ taħt fuq.
Pull the plunger out slowly until the desired amount of medication is withdrawn into the dispenser (see figure).
Iġbed il- planġer ’ l barra bil- mogħod sa kemm l- ammont mixtieq tal- mediċina tinġibed fid- dispenser (ara l- figura).
Turn the entire unit right side up and remove the dispenser slowly from the bottle.
Erġa dawwar kollox kif suppost bit- tapp ’ l fuq, u neħħi d- dispenser mill- flixkun bil- mogħod.
Dispense directly into mouth and swallow.
Itfa dirrettament fil- ħalq u ibla ’.
Do not mix with any liquid prior to dispensing.
Tħallatx ma ’ xi likwidu ieħor qabel l- għotja.
Close bottle with child-resistant cap after each use.
Agħlaq il- flixkun bit- tapp reżistenti għat- tfal wara kull użu.
Immediately after administration:
Immedjatament wara l- amministrazzjoni:
Disassemble dispenser, rinse under running tap water and air dry prior to next use.
Żarma d- dispenser, laħlaħ taħt l- ilma tal- vit u nixxef b’ mod naturali qabel ma terġa tużaħ.
Care should be taken to avoid contact of the skin with the suspension.
Għandu jkun hemm attenzjoni biex jiġi evitat kuntatt tal- ġilda mas- suspensjoni.
If such contact occurs, wash thoroughly with soap and water.
Jekk iseħħ kuntatt, aħsel sew bis- sapun u l- ilma.
If you take more CellCept than you should:
87 Jekk tieħu aktar CellCept milli suppost:
If you take more suspension than you have been told to take, or if someone else accidentally takes your medicine, immediately see a doctor or go to a hospital straight away.
Jekk tieħu aktar suspensjoni milli qalulek tieħu, jew jekk xi ħadd ieħor jieħu l- mediċina tiegħek bi żball, ara tabib jew mur l- isptar minnufih.
86 If you stop taking CellCept:
Jekk tieqaf tieħu CellCept:
Disorders of the lungs such as pneumonia, bronchitis, shortness of breath, cough, fluid on the lungs/ chest cavity, sinus problems.
Disturbi fil- pulmun bħal pnewmonja, bronkite, qtugħ ta 'nifs, sogħla, ilma fil- pulmun/ spazju tas- sider u
Do not use after the expiry date stated on the carton and bottle label (EXP).
M’ għandekx tuża wara id- data ta ’ skadenza li tidher fuq il- kartuna u t- tikketta tal- flixkun wara JIS.
87 The shelf-life of the reconstituted suspension is two months.
Is- suspensjoni rikostitwita ddum tajba xaharejn.
The pharmacist will write the date of expiration on the bottle label in the black box next to "Use before".
L- ispiżjar se jikteb id- data ta ’ meta tiskadi fuq it- tikketta tal- flixkun fil- kaxxa s- sewda ħdejn ‘ Uża qabel ’.
Do not use the suspension past this expiry date.
Tużax s- suspensjoni wara d- data li tiskadi.
Powder for oral suspension: do not store above 30°C.
Taħżinx f’ temperatura ’ l fuq minn 30°C.
Reconstituted suspension: do not store above 30°C.
Taħżinx f’ temperatura ’ l fuq minn 30°C.
- The active substance is mycophenolate mofetil
- Is- sustanza attiva hi mycophenolate mofetil.
CellCept 1 g/ 5 ml powder for oral suspension:
CellCept 1 g / 5 ml trab għal suspensjoni orali:
A bottle adapter and 2 oral dispensers are also provided.
Hemm ipprovdut ukoll adattatur tal- flixkun u 2 dispensers orali.
Marketing Authorisation Holder
89 Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq
Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
Roche Registration Ltd 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW Ir- Renju Unit
Ireland Roche Products (Ireland) Ltd.
90 Ireland Roche Products (Ireland) Ltd.
Tel: +421 - 2 52638201
Tel: +421 - 2 5263820
Lietuva UAB “ Roche Lietuva” Tel: +370 5 2546799
Lietuva UAB “ Roche Lietuva ” Tel: +370 5 2362718
This leaflet was last approved on {MM/ YYYY}
Dan il- fuljett kien approvat l- aħħar f ’ [data]
90 PACKAGE LEAFLET:
91 FULJETT TA 'TAGĦRIF:
CellCept 500 mg tablets mycophenolate mofetil
Pilloli CellCept 500 mg mycophenolate mofetil
CellCept tablets are used to prevent your body rejecting a transplanted kidney, heart or liver.
Il- pilloli CellCept jintużaw biex ma jħallux il- ġisem tiegħek jiċħad kilwa, qalb jew fwied trapjantati.
- If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the
- Tieħux CellCept: Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal mycophenolate mofetil,
other ingredients of CellCept.
mycophenolic acid, jew sustanzi oħra ta 'CellCept.
91 If you answer yes to any of the following questions talk to your doctor before you start to take CellCept:
92 Jekk twieġeb iva għal xi waħda minn dawn il- mistoqsijiet li ġejjin, kellem lit- tabib qabel ma tibda tieħu CellCept:
(which are sometimes given to patients after a transplant operation), cholestyramine (used to treat patients with high cholesterol), rifampicin (antibiotic), antacids, phosphate binders (used in patients with chronic renal failure to reduce the absorption of phosphate) or any other medicines (including those you can buy without a prescription) that your doctor does not know about?
jingħataw lill- pazjenti wara operazzjoni ta ’ trapjant), cholestyramine (użat biex jikkura pazjenti b’ kolesterol għoli), rifampicin (antibijotiku), antaċidi, phosphate binders (użati f’ pazjenti b’ insuffiċjenza renali kronika biex inaqqsu l- assorbiment tal- fosfat) jew xi mediċini oħra (anki dawk mingħajr riċetta) li t- tabib tiegħek ma jafx dwarhom?
Pregnancy and breast-feeding:
Tqala u Treddigħ:
Your doctor should advise you about using contraception before taking CellCept, whilst taking CellCept, and for six weeks after you have stopped taking CellCept.
It- tabib tiegħek għandu jagħtik parir dwar l- użu ta ’ kontraċettivi qabel ma tieħu CellCept, waqt li qed tieħu CellCept u għal sitt ġimgħat wara li tieqaf tieħu CellCept.
The recommended daily dose is 4 tablets (2 g of the active ingredient) taken as 2 separate doses.
Id- doża rakkomandata ta ’ kuljum hija ta ’ 4 pilloli (2 g tas- sustanza attiva) li tittieħed bħala żewġ dożi separati.
This means taking 2 tablets in the morning then 2 tablets in the evening.
Dan ifisser 2 pilloli filgħodu u 2 pilloli filgħaxija.
The recommended daily dose is 6 tablets (3 g of the active ingredient) taken as 2 separate doses.
Id- doża rakkomandata ta ’ kuljum hija 6 pilloli (3 g tas- sustanza attiva) li jittieħdu bħala żewġ dożi separati.
This means taking 3 tablets in the morning then 3 tablets in the evening.
Dan ifisser li trid tieħu 3 pilloli filgħodu u wara 3 pilloli filgħaxija.
Children:
93 Tfal:
92 Liver Transplant
Trapjant tal- Fwied
The recommended daily dose is 6 tablets (3 g of the active ingredient) taken as 2 separate doses.
Id- doża rakkomandata ta ’ kuljum hija ta ’ 6 pilloli kuljum (3g tas- sustanza attiva) li tittieħed bħala żewġ dożi separati.
This means taking 3 tablets in the morning and then 3 tablets in the evening.
Dan ifisser li trid tieħu 3 pilloli filgħodu u wara 3 pilloli filgħaxija.
Swallow your tablets whole with a glass of water.
Ibla ’ l- pilloli tiegħek sħaħ ma ’ tazza ilma.
Do not break or crush them.
Tkissirhomx u tfarrakomx.
If you take more tablets than you have been told to take, or if someone else accidentally takes your medicine, immediately see a doctor or go to a hospital straight away.
Jekk tieħu aktar pilloli milli qalulek tieħu, jew jekk xi ħadd ieħor jieħu l- mediċina tiegħek bi żball, ara tabib jew mur l- isptar minnufih.
POSSIBLE SIDE EFFECTS
4 EFFETTI SEKONDARJI LI JISTA ’ JKOLLU
General unwanted effects affecting your body as a whole could include hypersensitivity (such as anaphylaxis, angioeodema), fever, lethargy, difficulty in sleeping, pains (such as abdominal, chest, joint/ muscle, pain on passing urine), headache, flu symptoms and swelling.
94 Effetti mhux mixtieqa ġenerali oħra li jistgħu jaffettwaw lill- ġismek kollu jistgħu jinkludu sensittività eċċessiva (bħal anafilassi, anġio- edima) deni, għeja, diffikultà biex torqod, uġigħ (bħal uġigħ addominali, fis- sider, fil- ġogi/ muskoli, uġigħ waqt li qed tgħaddi l- awrina), uġigħ ta 'ras, sintomi ta' riħ, u nefħa.
93 Other unwanted effects may include:
Effetti oħra mhux mixtieqa jistgħu jinkludu:
Do not use the tablets after the expiry date stated on the carton (EXP).
M’ għandekx tuża l- pilloli wara id- data ta ’ skadenza li tidher fuq il- kartuna wara JIS.
Keep in outer carton in order to protect from light.
Aħżen fil- kartuna ta ’ barra, sabiex tilqa ’ mid- dawl.
CellCept tablets: microcrystalline cellulose polyvidone (K-90) croscarmellose sodium magnesium stearate
Pilloli CellCept: microcrystalline cellulose polyvidone (K90) croscamellose sodium
94 What CellCept looks like and contents of the pack
Id- Dehra ta ’ CellCept u l- kontenuti tal- pakkett:
1 carton contains 50 tablets (in blister packs of 10) 1 carton contains 150 tablets (in blister packs of 10)
CellCept 500 mg pilloli: kartuna 1 fiha 50 pillola (f’ paketti ta ’ folji ta ’ 10) kartuna 1 fiha 150 pillola (f’ paketti ta ’ folji ta ’ 10)
Tablets:
Pilloli:
Eesti Roche Eesti OÜ Tel: + 372 - 6 177 380
96 Eesti Österreich Roche Eesti OÜ Tel: + 372 - 6 177 380
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
RAPPORT TA ’ VALUTAZZJONI PUBBLIKA EWROPEA (EPAR)
This document is a summary of the European Public Assessment Report (EPAR).
Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropea (EPAR).
It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Huwa jispjega kif il- Kumitat għall- 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 inti teħtieġ aktar informazzjoni dwar il- kondizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta ’ Tagħrif (ara parti mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
What is CELSENTRI?
X’ inhu CELSENTRI?
CELSENTRI is a medicine containing the active substance maraviroc.
CELSENTRI huwa mediċina li fiha s- sustanza attiva maraviroc.
It is available as blue, oval tablets (150 or 300 mg).
Jiġi bħala pilloli blu, ovali (tal- 150 jew 300 mg).
What is CELSENTRI used for?
Għalxiex jintuża CELSENTRI?
CELSENTRI is an antiviral medicine.
CELSENTRI hu mediċina antivirali.
It is used in combination with other antiviral medicines to treat adults who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Jintuża flimkien ma ’ mediċini oħra antivirali fit- trattament ta ’ adulti infettati bil- virus ta ’ l- immunodefiċjenza umana ta ’ l- ewwel tip (HIV- 1), virus li jikkawża l - acquired immune deficiency syndrome (AIDS).
CELSENTRI is only used in patients who have been treated for HIV infection before and only when the HIV-1 they are infected with is ‘ CCR5-tropic’, which is determined by a blood test.
CELSENTRI jintuża biss f’ pazjenti li kienu ġew ittrattati għal infezzjoni ta ’ l- HIV qabel u biss meta l - HIV- 1 li jkunu infettati bih ikun ‘ CCR5- tropic ’, li jiġi stabbilit permezz ta ’ test tad- demm.
This means that the virus, when infecting a cell, attaches to a specific protein called CCR5 on the surface of the cell.
Dan ifisser ukoll li l- virus, meta jinfetta ċellola, jeħel ma ’ proteina tas- superfiċje magħrufa bħala CCR5 fuq is- superfiċje taċ- ċellola.
How is CELSENTRI used?
Kif jintuża CELSENTRI?
Treatment with CELSENTRI should be initiated by a doctor who has experience in the management of HIV infection.
It- trattament b’ CELSENTRI għandu jinbeda minn tabib li jkollu esperjenza fil- ġestjoni ta ’ l- infezzjoni ta ’ l- HIV.
Before treatment, the doctor must check that the patient ’ s blood only shows infection with CCR5-tropic virus, using a newly drawn blood sample and a reliable ‘ tropism test’.
Qabel it- trattament, it- tabib ikollu jiċċekkja jekk id- demm tal- pazjent jurix biss infezzjoni b’ virus li jkun CCR5- tropic, bl- użu ta ’ kampjun tad- demm miġbud frisk u ‘ tropism test ’ ta ’ min joqgħod fuqu.
The recommended dose is 150, 300 or 600 mg twice a day, depending on the other medicines that the patient is taking.
Id- doża rakkomandata hi 150, 300 jew 600 mg darbtejn kuljum, skond il- mediċini l- oħra li jkun qed jieħdu l- pazjent.
It can be taken with or without food.
Jista ’ jittieħed ma ’ l- ikel jew waħdu.
CELSENTRI should be used with caution in patients aged over 65 years and in patients who have problems with their liver.
CELSENTRI għandu jintuża b’ kawtela f’ pazjenti ta ’ iktar minn 65 sena u f’ pazjenti li jkollhom problemi fil- fwied.
Patients who have kidney problems may need to take CELSENTRI less frequently if they are taking other medicines that are broken down in the body (metabolised) in the same way as CELSENTRI, and their response to treatment should be closely monitored.
Il- pazjenti li jkollhom problemi bil- kliewi jista ’ jkollhom jieħdu CELSENTRI inqas spiss jekk ikunu qed jieħdu mediċini oħra li jitkissru (jiġu metabolizzati) fil- ġisem bl- istess mod bħal CELSENTRI, u r- rispons għat - trattament għandu jiġi sorveljat strettament.
For more information, see the Summary of Product Characteristics (also part of the EPAR).
Għal aktar tagħrif, ara s- Sommarju tal- Karatteristiċi tal - Prodott (ukoll parti mill- EPAR).
There is no information on switching to CELSENTRI from another type of medicine for HIV infection in patients whose HIV is being treated successfully, when no virus can be detected in their blood.
M’ hemmx tagħrif dwar il- qlib għal CELSENTRI minn tip ieħor ta ’ mediċina għall- infezzjoni ta ’ l - HIV fil- pazjenti li l- HIV tagħhom ikun qiegħed jiġi ttrattat b’ suċċess, meta l- ebda virus ma jkun jista ’ jinstab fid- demm tagħhom.
There is also no information on the re-use of CELSENTRI in patients who have taken it in the past, but in whom it stopped working.
Lanqas ma hemm tagħrif dwar l- użu mill- ġdid ta ’ CELSENTRI f’ pazjenti li jkunu ħaduh fl- imgħoddi, iżda li fihom ma jkunx għadu jaħdem.
Other treatments should be considered in these cases.
F’ dawn il- każi għandhom jiġu kkunsidrati trattamenti oħra.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged uses this protein to enter the cells.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif jaħdem CELSENTRI?
By attaching itself to the protein, maraviroc prevents it from entering the cells.
Is- sustanza attiva f’ CELSENTRI, maraviroc, hu ‘ antagonist tas- CCR5 ’.
Maraviroc cannot work when the virus in a blood sample attaches to another protein called CXCR4, or when it can attach to both CCR5 and CXCR4.
Maraviroc ma jkunx jista ’ jaħdem meta l- virus fil- kampjun tad- demm jeħel ma ’ proteina oħra magħrufa bħala CXCR4, jew meta jkun jista ’ jeħel kemm ma ’ CCR5 u kemm ma ’ CXCR4.
As HIV can only reproduce itself within cells, CELSENTRI, taken in combination with other antiviral medicines, reduces the level of CCR5-tropic HIV in the blood of patients, and keeps it at a low level.
Billi l- HIV jista ’ jirriproduċi lilu nnifsu fiċ- ċelloli biss, CELSENTRI, meta meħud flimkien ma ’ mediċini antivirali oħra, inaqqas il- livelli ta ’ HIV CCR5- tropic fid- demm tal- pazjenti, u jżommu f’ livelli baxxi.
CELSENTRI does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
CELSENTRI ma jfejjaqx l- infezzjoni ta ’ l- HIV jew l- AIDS, iżda jbiegħed il- ħsara lis- sistema immunitarja u l- iżvilupp ta ’ infezzjonijiet u mardiet marbuta ma ’ l - AIDS.
How has CELSENTRI been studied?
Kif ġie studjat CELSENTRI?
The effects of CELSENTRI were first tested in experimental models before being studied in humans.
L- effetti ta ’ CELSENTRI għall- ewwel ġew ittestjati f’ mudelli esperimentali qabel ma ġew studjati fuq il- bniedem.
CELSENTRI was studied in two main studies involving a total of 1,076 patients with CCR5-tropic HIV infection.
CELSENTRI ġie studjat f’ żewġ studji ewlenin li fihom b’ kollox ħadu sehem 1, 076 pazjent b’ infezzjoni ta ’ l- HIV CCR5- tropic.
The patients had taken other treatments for HIV for at least six months, but these had stopped working.
Il- pazjenti kienu ħadu trattamenti oħra għall- HIV għal ta ’ l- inqas sitt xhur, iżda dawn kienu waqfu jaħdmu.
The effects of CELSENTRI, taken once or twice a day, were compared with those of placebo (a dummy treatment).
L- effetti ta ’ CELSENTRI, meħud darba jew darbtejn kuljum, tqabblu ma ’ dawk ta ’ plaċebo (trattament finta).
All of the patients also took ‘ optimised background therapy’ (a combination of other antiviral medicines chosen for each patient as it had the best chances of reducing the levels of HIV in the blood).
Il- pazjenti kollha ħadu wkoll ‘ terapija ottimizzata fl- isfond ’ (kombinazzjoni ta ’ mediċini antivirali oħra magħżula għal kull pazjent minħabba li din kellha l- aqwa ċans li tnaqqas il- livelli ta ’ l- HIV fid- demm).
The main measure of effectiveness was the reduction in the levels of HIV in the blood (viral load) after 24 weeks.
Il- kejl ewlieni ta ’ l- effikaċja kien it - tnaqqis fil- livelli ta ’ l- HIV fid- demm (tagħbija virali) wara 24 ġimgħa.
What benefit has CELSENTRI shown during the studies?
X’ inhu l- benefiċċju ta ’ CELSENTRI li ntwera f’ dawn l- istudji?
CELSENTRI was more effective than placebo in reducing viral loads, when taken in combination with optimised background therapy.
CELSENTRI kien iktar effettiv mill- plaċebo fit- tnaqqis tat- tagħbijiet virali meta meħud flimkien ma ’ terapija ta ’ sfond ottimizzata.
Looking at the results of the two studies taken together, viral loads had fallen by an average of 99% after 24 weeks in the patients adding CELSENTRI to optimised background therapy, compared with 90% in those adding placebo.
L- analiżi tar- riżultati taż- żewġ studji meħudin flimkien uriet li t - tagħbijiet virali naqsu b’ medja ta ’ 99% wara 24 ġimgħa f’ pazjenti li żiedu CELSENTRI mat- terapija ta ’ sfond ottimizzata, meta mqabbla ma ’ 90% ta ’ dawk li żiedu l- plaċebo.
The proportion of patients who had undetectable levels of HIV in their blood was about 45% when CELSENTRI was added to optimised background therapy compared with 23% of the patients receiving optimised background therapy only.
Il- proporzjon ta ’ pazjenti li kellhom livelli ta ’ HIV fid- demm baxxi wisq biex jiġu reġistrati kien madwar 45% meta CELSENTRI żdied mat- terapija ta ’ l- isfond ottimizzata mqabbla ma ’ 23% tal- pazjenti li ngħataw it- terapija ta ’ sfond biss.
Similar results were also observed when looking at the patients who continued treatment with CELSENTRI 300 mg twice a day for 48 weeks.
Ġew osservati riżultati simili f’ pazjenti li komplew it- trattament b’ CELSENTRI 300 mg darbtejn kuljum għal 48 ġimgħa.
The once- and twice-daily doses of CELSENTRI were of similar effectiveness.
Id- dożi ta ’ CELSENTRI darba jew darbtejn kuljum kellhom effikaċja simili.