qanastek/EMEA-V3 huggingface dataset:
Common side effects likely to affect less than 1 in 10, but more than 1 in 100 people:  Changes in different laboratory parameters, including increase in liver enzymes, renal parameters such as creatinine, potassium, blood sugar, blood lipids, cholesterol, phosphates, magnesium, calcium and uric acid  Kidney problems with increased levels of urea  Disorders of the digestive system such as constipation, indigestion, flatulence, belching, inflammation of the mouth, oesophagus, stomach, intestine, liver or pancreas and gastrointestinal bleeding  Convulsions, increased tension in the muscles, shaking and muscle weakness, joint pain
Effetti sekondarji komuni li x’ aktax jaffettwaw anqas minn persuna 1 f’ kull 10 imma aktar minn 1 f’ kull 100 persuna. • Bidliet fil- parametri tal- laboratorju, li jinkludi żieda fl- enżimi tal- fwied, parametric tal- kliewi bħal kreatinin u urea, potassjum, iz- zokkor fid- demm, lipidi fid- demm, kolesterol, phosphates, manjesju, kalċju u aċidu uriku • Disturbi tal- kliewi b’ żiedafil- livelli ta ’ urea
42  Sleeplessness dizziness and headache, tingling or numbness, change of the sense of taste, loss of appetite, weight loss  Inflammation and infections of the respiratory and gastrointestinal tract, sore throat, inflammation of the sinuses, runny and itchy nose  Skin cancer or non cancerous growth of the skin and fungal infections of the skin and vagina  Changes in blood pressure, faster heart beat, dilation of blood vessels  Fluid retention in the body, fever, discomfort, lethargy and weakness  Inflammation of the liver, yellowing of the skin and whites of the eyes
46 • Disturbi fis- sistema diġestiva bħal stitikezza, indiġestjoni, gass fl- istonku, infjammazzjoni tal - ħalq, l- esofagu, l- istonku, l- imsaren, il- fwied jew il- frixa u emorraġija gastrointestinali. • Aċċessjonijiet, żieda fit- tensjoni tal- muskoli, rogħda u debolezza muskolari, uġigħ fil- ġogi • Nuqqas ta ’ rqad, stordamenti u uġigħ ta ’ ras, tnemin jew tirżiħ, bidla fis- sensazzjoni ta ’ togħma, nuqqas t’ aptit, nuqqas ta ’ piż • Infjammazzjoni u infezzjonijiet fl- apparat respiratorju u gastrointestinali, uġigħ fil- griżmejn, infjammazzjoni tas- sinus, imnieħer iqattar jew bil- ħakk • Kanċer tal- ġilda jew żvilupp mhux kanċeroġeniku u infezzjonijiet fungali tal- ġilda u l- vaġina • Bidliet fil- pressjoni tad- demm, il- qalb tħabbat aktar malajr, jitwessgħu l- vażi tad- demm • Żamma ta ’ fluwidu fil- ġisem, deni, skonfort, letarġija u debbolezza • Infjammazzjoni tal- fwied, ġilda u l- abjad tal- għajnejn li jisfaru
Uncommon side effects likely to affect less than 1 in 100 but more than 1 in 1000 people  Proliferation of the lymphatic tissue, including malignant tumours  Inflammation or infections of the heart and its valves and of the membrane that covers the brain and spinal cord
Effetti sekondarji rari li x’ aktarx jaffettwaw inqas minn persuna 1 f’ 100 jew aktar minn persuna 1 f’ 1000 • Proliferazzjoni tat- tessut linfatiku, li jinkludi tumuri malinni • Infjammazzjoni jew infezzjonijiet tal- qalb u l- valvi tagħha u tar- rita li tgħatti l- moħħ u l- ispina dorsali
Other side effects that have been reported where frequency has not been established  Hypersensitivity (allergic) reactions
Effetti sekondarji oħra li ġew rapportati iżda fejn il- frekwenza ma ġietx stabbilita Reazzjonijiet (allerġiċi) ta ’ sensittività eċċessiva
Do not stop taking your medicine unless you have discussed this with your doctor first.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, waqt li qed tieħu Mycophenolate mofetil Teva għid lit - tabib jew lill- ispiżjar tiegħek.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Madankollu, m’ għandekx tieqaf tieħu l- mediċina qabel ma tkun iddiskutejtha mat- tabib tiegħek.
HOW TO STORE MYCOPHENOLATE MOFETIL TEVA
KIF TAĦŻEN MYCOPHENOLATE MOFETIL TEVA
Do not use Mycophenolate mofetil Teva after the expiry date as stated on the blister and carton.
Tużax Mycophenolate mofetil Teva wara d- data ta ’ skadenza li tidher fuq il- kartuna wara JIS.
The expiry date refers to the last day of that month.
Id- data ta ’ skadenza tirreferi għal l- aħħar jum ta ’ dak ix- xahar.
This medicine does not require any special storage conditions.
Din il- mediċina m’ għandiex bżonn kundizzjonijiet ta ’ ħażna speċjali
What Mycophenolate mofetil Teva contains:
X’ fih Mycophenolate mofetil Teva:
- The active substance is mycophenolate mofetil.
- Is- sustanza attiva hi 250 mg mycophenolate mofetil.
Each capsule contains 250 mg mycophenolate
Kull kapsula fiha 250 mg mycophenolate
mofetil
mofetil
The other ingredients are:
- Is- sustanzi l- oħra huma:
Capsule content:
Il- Kontenut tal- kapsula:
Pregelatinised maize starch Povidone K-30 Croscarmellose sodium Magnesium stearate
Pregelatinised maize starch Povidone K- 30 Croscarmellose sodium Magnesium stearate
Capsule shells:
Il- qoxra tal- kapsuli:
Cap:
47 Ras:
43 Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin Black ink containing: shellac, black iron oxide (E172), propylene glycol and potassium hydroxide
Red iron oxide (E127) Yellow iron oxide (E110) Titanium dioxide (E171) Gelatin Il- linka sewda tikkonsisti minn shellac, black iron oxide (E172), propylene glycol u potassium hydroxide
What Mycophenolate mofetil Teva looks like and contents of the pack
Id- dehra ta ’ Mycophenolate mofetil Teva u d- daqs tal- pakkett
Hard capsules:
Kapsuli iebsin:
Cap: light blue opaque printed ‘ M’ axially in black ink.
Il- korp; lewn il- karamelli opak, li fuqu hemm stampat ‘ 250 ’ b’ mod assjali b’ linka sewda Ir- ras: kaħlanija ċara opaka li fuqha hemm stampat “ M ” b’ mod assjali b’ linka sewda.
Mycophenolate mofetil Teva 250 mg hard capsules are available in PVC/ PVdC -aluminium blisters in pack sizes of 100 or 300 capsules per carton.
Mycophenolate mofetil Teva 250 mg kapsuli iebsin jiġu f’ pakketti tal- folji tal- PVC/ PVdC- aluminju f’ daqsijiet ta ’ 100 jew 300 kapsula f’ kull kartuna
Marketing Authorisation Holder and Manufacturers
Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur
Marketing Authorisation Holder Teva Pharma B. V.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq TEVA Pharmaceutical Works Co. Ltd.
Computerweg 10 3542 DR Utrecht The Netherlands
Computerweg 10, 3542 DR Utrecht, l- Olanda
Manufacturers Teva Pharmaceutical Works Private Limited Company Pallagi út 13 Debrecen H-4042 Hungary
Debrecen H- 4042, l- Ungerija
TEVA Pharmaceutical Works Private Limited Company H-2100 Gödöllő Táncsics Mihály út 82 Hungary
TEVA Pharmaceuticals Works Pribate Limited Company H- 2100 Gödöllő Táncsics Mihály út 82 L- Ungerija
TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG UK
TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG Ir- Renju Unit
Swensweg 5 2031 GA Haarlem The Netherlands
Swensweg 5 2031 GA Haarlem L- Olanda
TEVA Santé SA Rue Bellocier 89107 Sens France
TEVA Santé SA
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) hhtp: / /www. emea. europa. eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu
INFORMATION FOR THE USER
51 FULJETT TA ’ TAGĦRIF:
Mycophenolate mofetil Teva 500mg film-coated tablets Mycophenolate mofetil
Mycophenolate mofetil Teva 500mg pilloli miksijin b’ rita Mycophenolate mofetil
Mycophenolate mofetil Teva is used to prevent your body rejecting a transplanted kidney, heart or liver.
Mycophenolate mofetil Teva jintuża biex jimpedixxi ‘ l ġisemek milli jirriġetta kliewi, qalb jew fwied trapjantati.
It is used in combination with other medicines with a similar function (i. e. ciclosporin and corticosteroids).
Huwa jintuża flimkien ma ’ mediċini oħra li għandhom l- istess funzjoni (i. e ciclosporin u corticosteroids).
Because of this, there is an increased risk of skin cancer.
Minħabba f’ hekk hemm riskju akbar ta ’ kanser tal- ġilda.
Therefore you should limit your exposure to sunlight and ultra violet (UV) light by wearing appropriate protective clothing and using a sunscreen with a high protection factor.
Għalhekk għandek tillimita l- espożizzjoni tiegħek għax- xemx u għad - dawl ultra vjola (UV) billi tilbes ilbies protettiv u billi tuża sunscreen b’ fattur ta ’ protezzjoni għoli.
45 If you answer yes to any of the following questions talk to your doctor before you start to take Mycophenolate mofetil Teva:
Jekk it- tweġiba hija iva għal xi waħda mill- mistoqsijiet li ġejjin kellem lit- tabib tiegħek qabel ma tibda ’ tieħu Mycophenolate mofetil Teva:
are sometimes given to patients after a transplant operation), cholestyramine (used to treat patients with high blood cholesterol), rifampicin (antibiotic), antacids, phosphate binders (used in patients with chronic kidney 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 lil pazjenti wara operazzjoni ta ’ trapjant), cholestyramine (użat biex jittratta pazjenti li għandhom livell għoli ta ’ kolesterol fid- demm), rifampicin (antibijotiku), antacidi, phosphate binders (użati f’ pazjenti li għandhom indeboliment renali kroniku li jnaqqas l- assorbiment ta ’ fosfat) jew xi mediċini oħra (inkluż dawk li tista ’ tixtri mingħajr riċetta) li t- tabib tiegħek ma jafx dwarhom?.
Your doctor will have to advise you what is
Meta tieħu Mycophenolate mofetil Teva ma ’ l- ikel u max- xorb It- teħid ta ’ l- ikel u x- xorb ma jaffettwax it- trattament tiegħek b’ Mycophenolate mofetil Teva.
Taking Mycophenolate mofetil Teva with food and drink Taking food and drink has no influence on your treatment with Mycophenolate mofetil Teva.
Tqala u treddigħ M’ għandekx tieħu Mycophenolate mofetil Teva jekk qed tredda ’.
Pregnancy and breast-feeding Do not take Mycophenolate mofetil Teva if you are breast-feeding.
It- tabib tiegħek għandu jirrakomandalek dwar l- użu ta ’ kontraċezzjoni qabel ma ’ tieħu Mycophenolate mofetil Teva, waqt li qed tieħu Mycophenolate mofetil Teva, u għal sitt ġimgħat wara li tkun waqaft tieħu Mycophenolate mofetil Teva.
Your doctor should advise you about using contraception before taking Mycophenolate mofetil Teva, whilst taking Mycophenolate mofetil Teva, and for 6 weeks after you have stopped taking Mycophenolate mofetil Teva. Mycophenolate mofetil Teva may cause spontaneous abortions or damage, including problems with development of the ears, to your unborn baby.
Dan għaliex Mycophenolate mofetil Teva jista ’ jikkaġuna abort spontanju jew ħsara, li jinkludu problemi fl- iżvilupp tal- widnejn tat- tarbija tiegħek li għadha ma twellditx.
The first dose will be given within 72 hours after the transplant operation.
L- ewwel doża għandha tingħata fi żmien 72 siegħa minn wara l- operazzjoni tat- trapjant.
The recommended daily dose is 4 tablets (2 g of the active ingredient) taken as 2 separate doses.
Id- doża rakkomandata hi ta ’ 4 pilloli (2 g tas- sustanza attiva) li jittieħdu bħala 2 dożi separati.
This means taking 2 tablets in the morning then 2 tablets in the evening.
Dan ifisser li tieħu 2 pilloli filgħodu u 2 pilloli filgħaxija.
The dose given will vary depending on the size of the child.
Id- doża li tingħata għandha tvarja skond id- daqs tat- tifel/ tifla.
The recommended daily dose is 6 tablets (3 g of the active ingredient) taken as 2 separate doses.
Id- doża rakkomandata ta ’ kuljum hi ta ’ 6 pilloli (3 g tas- sustanza attiva) li tittieħed f’ żewġ dożi separati.
This means taking 3 tablets in the morning then 3 tablets in the evening.
Dan ifisser li għandhom jittieħdu 3 pilloli filgħodu u 3 pilloli filgħaxija.
No data are available to recommend the use of Mycophenolate mofetil Teva in children and adolescents who have received a heart transplant.
L- ebda tagħrif ma hu disponibbli sabiex Mycophenolate mofetil Teva jiġi rakkomandat fi tfal u adoloxxenti li rċevew trapjant tal- qalb.
46 Adults:
Adulti:
The first dose of oral Mycophenolate mofetil Teva will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medicines.
53 L- ewwel doża ta ’ Mycophenolate mofetil Teva li tittieħed mill- ħalq għandha tingħatalek ta ’ lanqas 4 ijiem wara l- operazzjoni ta ’ trapjant u meta tkun kapaci tibla ’ l- mediċini mill- ħalq.
This means taking 3 tablets in the morning then 3 tablets in the evening.
Dan ifisser li jittieħdu 3 pilloli filgħodu u mbagħad 3 pilloli filgħaxija.
No data are available to recommend the use of Mycophenolate mofetil Teva in children and adolescents who have received a liver transplant.
L- ebda tagħrif ma hu disponibbli sabiex Mycophenolate mofetil Teva jiġi rakkomandat fi tfal li rċevew trapjant tal- fwied.
Method and route of administration Swallow your tablets whole with a glass of water.
Mod ta ’ kif u mnejn jingħata Ibla ’ l- kapsuli tiegħek b’ mod sħiħ ma’ tazza ilma.
Do not break or crush them.
M’ għandekx tkissirhom jew titħannhom.
Treatment will continue for you as long as you need immunosuppression to prevent your body from rejecting your transplanted organ.
It- trattament ser jissokta għalik sakemm ikollok bżonn l- immunosoppressjoni sabiex jimpedixxik lil ġismek milli jirriġetta l- organu ttrapjantat.
If you take more Mycophenolate mofetil Teva than you should It is important not to take too many tablets.
Jekk tieħu aktar Mycophenolate mofetil Teva milli suppost Huwa importanti li ma tieħux aktar pilloli milli suppost.
Contact your nearest hospital Accident and Emergency department or a doctor for advice if you have swallowed more tablets than you have been told to take or if you think a child has swallowed any.
Ikkuntattja l- eqreb dipartiment ta ’ l- Aċċidenti u l- Emerġenza fi sptar jew tabib għal parir jekk blajt aktar pilloli milli qalulek biex tieħu jew jekk taħseb li t- tifel/ tifla tiegħek belgħet minnhom.
Very common side effects likely to affect more than 1 in 10 people:  Diarrhoea, vomiting, feeling sick  Decrease in normal amounts of different blood cells, which can result in increased risk of infections, bruising, bleeding, breathlessness and weakness  Bacterial, fungal and viral infections of the digestive and urinary tract, cold sores and shingles
Effetti sekondarji komuni ħafna li x’ aktarx jaffettwaw aktar minn persuna 1 f’ 10: • Dijarea, remettar, tħossok ma tiflaħx • Tnaqqis fl- ammonti normali ta ’ ċelluli differenti tad- demm, li jistgħu jirriżultaw f’ riskju ogħla ta ’ infezzjonijiet, tbenġil, emorraġiji, qtugħ ta ’ nifs u debbulezza • Infezzjonijiet batteriċi, fungali u viral ital- passaġġ diġestiv u urinarju, nfafet fuq ix- xofftejn u ħruq ta ’ Sant Antnin
Common side effects likely to affect less than 1 in 10, but more than 1 in 100 people:  Changes in different laboratory parameters, including increase in liver enzymes, renal parameters such as creatinine, potassium, blood sugar, blood lipids, cholesterol, phosphates, magnesium, calcium and uric acid  Kidney problems with increased levels of urea  Disorders of the digestive system such as constipation, indigestion, flatulence, belching, inflammation of the mouth, oesophagus, stomach, intestine, liver or pancreas and gastrointestinal bleeding  Convulsions, increased tension in the muscles, shaking and muscle weakness, joint pain  Sleeplessness dizziness and headache, tingling or numbness, change of the sense of taste, loss of appetite, weight loss 47  Inflammation and infections of the respiratory and gastrointestinal tract, sore throat, inflammation of the sinuses, runny and itchy nose  Skin cancer or non cancerous growth of the skin and fungal infections of the skin and vagina  Changes in blood pressure, faster heart beat, dilation of blood vessels  Fluid retention in the body, fever, discomfort, lethargy and weakness  Inflammation of the liver, yellowing of the skin and whites of the eyes
Effetti sekondarji komuni li x’ aktax jaffettwaw anqas minn persuna 1 f’ kull 10 imma aktar minn 1 f’ kull 100 persuna. • Bidliet fil- parametri tal- laboratorju, li jinkludi żieda fl- enżimi tal- fwied, parametric tal- kliewi bħal kreatinin u urea, potassjum, iz- zokkor fid- demm, lipidi fid- demm, kolesterol, phosphates, manjesju, kalċju u aċidu uriku • Disturbi tal- kliewi b’ żieda fil- livelli ta ’ l- urea • Disturbi fis- sistema diġestiva bħal stitikezza, indiġestjoni, gass fl- istonku, tifwieq, infjammazzjoni tal- ħalq, l- esofagu, l- istonku, l- imsaren, il- fwied jew il- frixa u emorraġija gastrointestinali. • Aċċessjonijiet, żieda fit- tensjoni tal- muskoli, rogħda u debolezza muskolari, uġigħ fil- ġogi
Do not stop taking your medicine unless you have discussed this with your doctor first.
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.
This medicine does not require any special storage conditions.
Din il- mediċina m’ għandiex bżonn kundizzjonijiet ta ’ ħażna speċjali.
The active substance is mycophenolate mofetil.
- Is- sustanza attiva hi 500 mg mycophenolate mofetil.
Tablet core:
Pilloli jikkonsistu minn:
Microcrystalline cellulose Povidone K-30 Magnesium stearate Croscarmellose sodium
Microcrystalline cellulose Povidone K- 30 Magnesium stearate Croscarmellose sodium
Tablet coat:
Il- kisi tal- pillola:
Hypromellose (HPMC 2910) Titanium dioxide (E171) Macrogol (PEG 400) Talc Indigo carmine aluminium lake (E132) Iron oxide black (E172) Iron oxide red (E172)
Hypromellose (HPMC 2910) Titanium dioxide (E171) Macrogol (PEG 400) Talc
48 What Mycophenolate mofetil Teva looks like and contents of the pack
Id- dehra ta ’ Mycophenolate mofetil Teva u d- daqs tal- pakkett
Pale purple, oval shaped film-coated tablet, debossed with "M500" on one side and plain on the other side.
Pilloli Mycophenolate mofetil Teva miksija b’ rita: pilloli miksija b’ rita ta ’ lewn il- lavanda pallida, f’ għamla ovali, intaljati “ M500 ” fuq naħa waħda u bla ebda disinn fuq in- naħa l- oħra.
Mycophenolate mofetil Teva 500 mg film-coated tablets are available in PVC/ PVdC -aluminium blisters in pack sizes of 50 or 150 tablets per carton.
Il- pilloli miksija b’ rita ta ’ Mycophenolate mofetil Teva 500 mg jiġu f’ pakketti tal- folji ta ’ PVC/ PVdC – aluminju li d- daqsijiet tagħhom huma ta ’ 50 jew 150 pillola f’ kull kartuna
Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur
Marketing Authorisation Holder Teva Pharma B. V.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq TEVA Pharmaceutical Works Co. Ltd.
Computerweg 10, 3542 DR Utrecht The Netherlands
Computerweg 10, 3542 DR Utrecht l- Olanda
Manufacturers Teva Pharmaceutical Works Private Limited Company Pallagi út 13.
Manifattur Teva Pharmaceutical Works Private Limited Company Pallagi út 13.
Debrecen H-4042 Hungary
Debrecen H- 4042, L- Ungerija
Teva Pharmaceuticals Works Private Limited Company H-2100 Gödöllő Táncsics Mihály ut 82 Hungary
Teva Pharmaceuticals Works Private Limited Company H- 2100 Gödöllő, Táncsics Mihály t 82 L- Ungerija
Teva UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG, UK
Teva UK Ltd Brampton Road Hampden Park Eastboure, East Sussex BN22 9AG, Ir- Renju Unit
This leaflet was last approved in {MM/ YYYY}.
Tel: + {Símanúmer} < {e- mail} >
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu.
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS} Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu
What is Myfenax?
X’ inhu Myfenax?
Myfenax is a medicine containing the active substance mycophenolate mofetil.
Myfenax huwa mediċina li fiha s- sustanza attiva mycophenolate mofetil.
It is available as capsules (250 mg) and tablets (500 mg).
Jiġi bħala kapsuli (250 mg) u pilloli (500 mg).
Myfenax is a ‘ generic medicine’.
Myfenax huwa ‘ mediċina ġenerika ’.
This means that Myfenax is similar to a ‘ reference medicine’ already authorised in the European Union (EU) called CellCept.
Dan ifisser li Myfenax jixbah lill - ‘ mediċina ta ’ referenza ’ diġà awtorizzata u li diġà tinsab disponibbli fl- Unjoni Ewropea (UE) magħrufa bħala CellCept.
For more information on generic medicines, see the question-and-answer document here.
Għal iktar tagħrif dwar il- mediċini ġeneriċi, ara d- dokument ta ’ mistoqsija u tweġiba hawn.
What is Myfenax used for?
Għal xiex jintuża Myfenax?
Myfenax is used to prevent the body from rejecting a transplanted kidney, heart or liver.
Myfenax jintuża biex il- ġisem ma jitħalliex jirreġetta kilwa, qalb jew fwied trapjantat.
It is used with ciclosporin and corticosteroids (other medicines used to prevent organ rejection).
Jintuża maċ - ċiklosporina u l- kortikosterojdi (mediċini oħra biex jipprevjenu r- riġettar ta ’ l- organi).
How is Myfenax used?
Kif jintuża Myfenax?
Myfenax treatment should be initiated and maintained by a qualified transplant specialist.
It- trattament b’ Myfenax għandu jinbeda u jiġi sorveljat minn speċjalista tat- trattamenti kwalifikat.
The way that Myfenax should be given and the dose depend on the type of organ transplant and the patient ’ s age and size.
Il- mod u d- doża li bih għandu jingħata Myfenax jiddependu mit- tip ta ’ organu trapjantat u mill- età u d- daqs tal- pazjent.
For kidney transplants, the recommended dose in adults is 1.0 g twice a day starting within 72 hours after the transplant.
Għat- trapjanti tal- kliewi, id- doża rakkomandata fl- adulti hija 1. 0 g darbtejn kuljum li għandha tinbeda 72 siegħa wara t- trapjant.
In children aged between two and 18 years, the dose of Myfenax is calculated depending on height and weight.
Fit- tfal ta ’ bejn sentejn u 18- il sena, id- doża ta ’ Myfenax tiġi kkalkulata skond it- tul u l- piż.
For heart transplants, the recommended adult dose is 1.5 g twice a day, starting within five days following the transplant.
Għat- trapjanti tal- qalb, id- doża rakkomandata għall- adulti hija ta ’ 1. 5 g darbtejn kuljum, li tinbeda fi żmien ħamest ijiem mit- trapjant.
For liver transplants in adults, mycophenolate mofetil should be given as an infusion (drip into a vein) for the first four days after the transplant, before the patient is switched to 1.5 g Myfenax twice a day as soon as it can be tolerated.
Għat- trapjanti tal- fwied fl- adulti, mycophenolate mofetil għandu jingħata bħala infużjoni (dripp fil - vina) għall- ewwel erbat ijiem wara t- trapjant, qabel ma l- pazjent tinbidillu d- doża għal 1. 5 g Myfenax darbtejn kuljum hekk kif din tkun tista ’ tiġi tollerata.
Myfenax is not recommended for use in children after heart or liver transplants because of a lack of information on its effects in this group.
Myfenax mhuwiex rakkomandat sabiex jintuża fuq tfal wara trapjanti tal- qalb u tal- fwied minħabba nuqqas ta ’ tagħrif dwar l- effetti tiegħu f’ dan il - grupp.
The dose may need to be adjusted in patients with liver or kidney disease.
Id- doża jista ’ jkollha tiġi aġġustata f’ pazjenti bi problemi b’ mard tal- fwied u tal- kliewi.
For more information, see the Summary of Product Characteristics (also part of the EPAR).
Għal iktar tagħrif, ara s- Sommarju tal- Karatteristiċi tal- Prodott (li wkoll huwa parti mill- EPAR).
How does Myfenax work?
Kif jaħdem Myfenax?
The active substance in Myfenax, mycophenolate mofetil, is an immunosuppressive medicine.
Is- sustanza attiva Myfenax, mycophenolate mofetil, hija mediċina immunosoppressiva.
In the body, it is converted into mycophenolic acid, which blocks an enzyme called ‘ inosine monophosphate dehydrogenase’.
Fil- ġisem, tinbidel f’ aċidu mikofenoliku, li jimblokka enzim magħruf bħala inosina monofosfat deidrogenażi (inosine monophosphate dehydrogenase).
By 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Dan l- enzim huwa importanti għall- formazzjoni tad- DNA 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non-commercial or commercial purposes, provided the EMEA is acknowledged preventing the production of new DNA, Myfenax reduces the rate at which the lymphocytes multiply.
(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 2008 Reproduction and/ or distribution of this document is authorised for non- commercial or commercial purposes, provided the EMEA is acknowledged fiċ- ċelloli, partikolarment fil- linfoċiti (tip ta ’ ċelloli tad- demm bojod li għandhom x’ jaqsmu fir- riġettar ta ’ l- organi trapjantati).
This makes them less effective at recognising and attacking the transplanted organ, lowering the risk of the organ being rejected.
Bil- prevenzjoni tal- produzzjoni ta ’ DNA ġdid, Myfenax inaqqas ir- rata li biha jimmultiplikaw ruħhom il- linfoċiti.
How has Myfenax been studied?
Kif ġie studjat Myfenax?
Because Myfenax is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicine (they produce the same levels of the active substance in the body).
Billi Myfenax huwa mediċina ġenerika, l- istudji ġew limitati għal testijiet li juru li huwa bijoekwivalenti għall- mediċina ta ’ referenza (jipproduċu l- istess livelli tas- sustanza attiva fil- ġisem).
What are the benefit and risk of Myfenax?
X’ inhu l- benefiċċju u r- riskju ta ’ Myfenax?
Because Myfenax is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Billi Myfenax huwa mediċina ġenerika u huwa bijoekwivalenti għall- mediċina ta ’ referenza, il - benefiċċji u r- riskji jitqiesu li kienu l- istess bħal dawk tal- mediċina ta ’ referenza.
Why has Myfenax been approved?
Għaliex ġie approvat Myfenax?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Myfenax has been shown to have comparable quality and to be bioequivalent to Cellcept.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (is- CHMP) ikkonkluda li, skond il - ħtiġiet ta ’ l- UE, intwera li Myfenax għandu kwalità komparabbli u li huwa bijoekwivalenti għal CellCept.
Therefore, the CHMP’ s view was that, as for CellCept, the benefit outweighs the identified risk.
Għalhekk, l- opinjoni tas- CHMP hija li, bħal fil- każ ta ’ CellCept, il- benefiċċji jegħlbu r - riskju identifikat.
The Committee recommended that Myfenax be given marketing authorisation.
Il- Kumitat irrakkomanda li Myfenax jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Myfenax:
Informazzjoni oħra dwar Myfenax:
The European Commission granted a marketing authorisation valid throughout the EU for Myfenax to Teva Pharma B. V. on 21 February 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Myfenax lil Teva Pharma B. V. fil- 21 ta ’ Frar 2008.
The full EPAR for Myfenax can be found here.
L- EPAR sħiħ għal Myfenax jista ’ jinstab hawn.
The full EPAR for the reference medicine can also be found on the EMEA’ s website.
L- EPAR sħiħ għall- mediċina ta ’ referenza jista ’ jinstab ukoll fuq is- sit ta 'l- internet ta ’ l- EMEA.
EU/ 1/ 07/ 438/ 001 EU/ 1/ 07/ 438/ 002 EU/ 1/ 07/ 438/ 003 EU/ 1/ 07/ 438/ 004
Numru ta ’ l- UE EU/ 1/ 07/ 438/ 001 EU/ 1/ 07/ 438/ 002 EU/ 1/ 07/ 438/ 003 EU/ 1/ 07/ 438/ 004
Myfenax Myfenax Myfenax Myfenax
Isem inventat Myfenax Myfenax Myfenax Myfenax
100 capsules 300 capsules 50 tablets 150 tablets
Daqs tal- pakkett 100 kapsula 300 kapsula 50 pillola 100 pillola
Myfenax 250 mg hard capsules
Myfenax 250 mg kapsuli iebsin
Hard capsule (capsule) The capsule: body is caramel opaque, printed with ‘ 250’ axially in black ink The capsule cap is light blue opaque printed ‘ M’ axially in black ink.
Kapsula, iebsa (kapsula) Il- kapsula: korp li hu lewn il- karamelli opak, li fuqu hemm stampat ‘ 250 ’ b’ mod assjali b’ linka sewda Ir- ras tal- kapsula hi kaħlanija ċara opaka li fuqha hemm stampat “ M ” b’ mod assjali b’ linka sewda.
Myfenax is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Myfenax hu indikat flimkien ma ’ ciclosporin u corticosteroids għall- profilassi ta ’ riġezzjoni akuta ta ’ trapjanti f’ pazjenti li jirċievu trapjanti renali, kardijaċi jew epatiċi alloġeniċi.
Treatment with Myfenax should be initiated and maintained by appropriately qualified transplant specialists.
Trattament b’ Myfenax għandu jiġi mibdi u mantenut minn speċjalisti kwalifikati xierqa fit- trapjanti.
Adults: oral Myfenax should be initiated within 72 hours following transplantation.
Myfenax mogħti mill- ħalq għandu jiġi mibdi fi żmien 72 siegħa minna wara t- trapjant.
Children and adolescents: the recommended dose of mycophenolate mofetil is 600 mg/ m2 administered orally twice daily (up to a maximum of 2 g daily).
Tfal u adolexxenti: id- doża rakkomandata ta ’ mycophenolate mofetil hija ta ’ 600mg/ m2 li tingħata mill- ħalq darbtejn kuljum (sa ’ massimu ta ’ 2 g kuljum).
Myfenax capsules should only be prescribed to patients with a body surface area of at least 1.25 m2.
Il- kapsuli Myfenax għandhom jiġu biss preskritti lil pazjenti b’ erja superfiċjali korporali ta ’ minn l- anqas 1. 25m2.
Patients with a body surface are of 1.25 to 1.5 m2 may be prescribed Myfenax capsules at a dose of 750 mg twice daily (1.5 g daily dose).
Pazjenti b’ erja superfiċjali korporali ta ’ bejn 1. 25- 1. 5 m2 għandhom jiġu ppreskritti l- kapsuli Myfenax f’ doża ta ’ 750 mg darbtejn kuljum (doża ta’ 1. 5 g kuljum).
Patients with a body surface area greater than 1.5 m2 may be prescribed Myfenax capsules at a dose of 1 g twice daily (2 g daily dose).
Pazjenti b ’ erja superfiċjali korporali akbar minn 1. 5 m2 għandhom jiġu ppreskritti l- kapsuli Myfenax f’ doża ta ’ 1 g darbtejn kuljum (doża ta ’ 2 g kuljum).
As some adverse reactions occur with greater frequency in this age group (see section 4.8) compared with adults, temporary dose reduction or interruption may be required; these will need to take into account relevant clinical factors including severity of reaction.
Peress li xi reazzjonijiet avversi jiġru bi frekwenza akbar f’ dan il- grupp ta ’ età (ara sezzjoni 4. 8) meta mqabbel ma ’ l- adulti, tnaqqis temporanju jew twaqqif tad- doża jista ’ jkun meħtieġ; dawn għandhom jiġu kkunsidrati ma ’ fatturi kliniċi relevanti li jinkludu s- severità tar- reazzjoni.
These are insufficient to make dosage recommendations and therefore use in this age group is not recommended.
Dawn huma insuffiċjenti sabiex isiru rakkomandazzjonijiet dwar id- doża u għalhekk l- użu f’ dan il - grupp ta ’ eta ’ mhux rakkomandat.
Adults: oral Myfenax should be initiated within 5 days following transplantation.
Myfenax mogħti mill- ħalq għandu jiġi mibdi fi żmien 5 ijiem wara t- trapjant.
2 Children and adolescents: no data are available for paediatric cardiac transplant patients, therefore use in this patients group is not recommended until further data to support this is available.
2 Tfal u adoloxxenti: m’ hemm l- ebda tagħrif disponibbli għal pazjenti tfal bi trapjant kardijaku, għalhekk l- użu f’ dan il- grupp ta ’ pazjenti mhux rakkomandat sakemm ikun hemm aktar tagħrif li jappoġġja dan.
Adults: intravenous mycophenolate should be administered for the first 4 days following hepatic transplant, with oral Myfenax initiated as soon after this as it can be tolerated.
Adulti: mycophenolate intravenuż għandu jiġi mogħti għall- ewwel 4 ijiem wara t- trapjant tal- fwied, b’ doża orali ta ’ Myfenax li tkun ittollerata li tinbeda kemm jista ’ jkun malajr wara dan.
Use in elderly (≥ 65 years)
Użu fl- anzjani (≥ 65 sena)
In renal transplant patients with severe chronic renal impairment (glomerular filtration rate < 25 ml min-1 1.73 m-2), outside the immediate post-transplant period, doses greater than 1 g administered twice a day should be avoided.
F’ pazjenti bi trapjanti tal- kliewi b’ indeboliment kroniku sever tal- kliewi (rata ta ’ filtrazzjoni glomerulari < 25 ml• min- 1• 1. 73 m- 2), barra milli fil- perijodu immedjat ta ’ wara t- trapjant, dożi akbar minn 1g mogħtijin darbtejn kuljum għandhom jiġu evitati.
Renal transplant rejection does not lead to changes in MPA pharmacokinetics; dosage reduction or interruption of Myfenax is not required.
Tiċħid tat- trapjant tal - kliewi ma jwassalx għal tibdil fil- farmakokinetiċi ta ’ MPA; tnaqqis fid- doża jew twaqqif ta ’ Myfenax mhux meħtieġ.
There is no basis for Myfenax dose adjustment following cardiac transplant rejection.
Ma hemm l- ebda bażi għal aġġustament fid- doża ta ’ Myfenax wara trapjant tal- qalb riġettat.
Hypersensitivity reactions to the active substance, to mycophenolic acid or any of the excipients..
Sensittività eċċessiva għas- sustanza attiva, għal mycophenolic acid, jew għal xi sustanzi mhux attivi
Myfenax is contraindicated in women who are breast-feeding (see section 4.6).
Myfenax huwa kontra- indikat f’ nisa li qed ireddgħu (ara sezzjoni 4. 6).
Patients receiving immunosuppressive regimens involving combinations of medicinal products, including Myfenax, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section 4.8).
Pażjenti li qegħdin fuq reġimens immunosoppressivi li jinvolvu kumbinazzjonijiet ta ’ prodotti mediċinali, li jinkludu Myfenax, huma f’ riskju akbar li jiżviluppaw limfomi u tumuri malinni oħrajn, b’ mod partikolari dawk tal- ġilda (Ara sezjoni 4. 8).
The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent.
Ir- riskju jidher li huwa aktar relatat ma ’ l- intensità u t- tul ta ’ l- immunosoppressjoni milli mill- użu ta ’ xi mediċina speċifika.
As general advice to minimise the risk for skin cancer, exposure to sunlight and ultra violet (UV) light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Bħala rakkomandazzjoni ġenerali biex jitnaqqas ir- riskju għal kanċer tal- ġilda, espożizzjoni għad- dawl tax- xemx u d- dawl ultra 3 vjola (UV) għandu jkun ristrett billi jintlibsu ħwejjeġ protettivi u billi jintuża sunskrin b’ fattur ta ’ protezzjoni għoli.
Patients receiving Myfenax should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression.
Pazjenti li jirċievu Myfenax għandhom jiġu mogħtija istruzzjonijiet biex jirraportaw minnufih kull evidenza ta ’ infezzjoni, tbenġil mhux mistenni, fsada jew xi manifestazzjoni oħra ta ’ dipressjoni tal - mudullun.
3 Patients treated with immunosuppressants, including Myfenax, are at increased risk for opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis (see section 4.8).
Pazjenti trattati b’ immunosoppressanti, inkluż Myfenax, huma f’ riskju akbar għall- infezzjonijiet opportunistiċi (mill- batterja, moffa, virus u protożoa), infezzjonijiet fatali u sepsis (ara sezzjoni 4. 8).
These infections are often related to a high total immunosuppressive burden and may lead to serious or fatal conditions that physicians should consider in the differential diagnosis in immunosuppressed patients with deteriorating renal function or neurological symptoms.
Dawn l- infezzjonijiet ħafna drabi huma relatati ma ’ esponiment immunosoppressiv totali għoli u jistgħu jwasslu għall- kundizzjonijiet serji jew fatali li t- tobba għandhom jikkunsidraw fid- dijanjosi differenzjali f’ pazjenti immunosoppressi b’ funzjoni tal - fwied li qed tiddeterjora jew b’ sintomi newroloġiċi.
Patients receiving Myfenax should be monitored for neutropenia, which may be related to Myfenax itself, concomitant medicinal products, viral infections, or some combination of these causes.
Pazjenti li jirċievu Myfenax għandhom jiġu sorveljati għan- newtropenja, li tista ’ tkun relatata ma ’ Myfenax innifsu, prodotti mediċinali konkomitanti, infezzjonijiet minn vajrusis, jew xi kumbinazzjoni ta ’ dawn il- kawżi.
Patients taking Myfenax should have complete blood counts weekly during the first month, twice monthly for the second and third months of treatment then monthly through the first year.
Pazjenti li jieħdu Myfenax għandhom jittieħdulhom l- għadd komplut tad- demm kull ġimgħa għall- ewwel xahar, darbtejn fix- xahar għat- tieni u t- tielet xhur ta ’ trattament imbagħad kull xahar matul l- ewwel sena.
If neutropenia develops (absolute neutrophil count < 1.3 x 103/μ l) it may be appropriate to interrupt or discontinue Myfenax.
Jekk tiżviluppa n- newtropenija (għadd ta ’ newtrofils assolut < 1. 3 103/ µl) jkun aħjar li Myfenax jiġi interrot jew imwaqqaf.
Patients should be advised that during treatment with Myfenax, vaccinations may be less effective and the use of live attenuated vaccines should be avoided (see section 4.5).
Il- pazjenti għandhom jiġu avżati li waqt trattament b’ Myfenax, il- vaċċinazzjonijiet jistgħu jkunu anqas effettivi u l- użu ta ’ vaċċini ħajjin imma attenwati għandhom jiġu evitati (ara sezzjoni 4. 5).
Because mycophenolate has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation, Myfenax should be administered with caution in patients with active serious digestive system disease.
Peress li mycophenolate ġie assoċjat ma ’ inċidenza akbar ta ’ reazzjonijiet avversi tas- sistema diġestiva, inkluż każi mhux tas- soltu ta ’ ulċerazzjoni tat- tubi gastrointestinali, emorraġija u perforazzjoni, Myfenax għandu jiġi mgħoti b’ kawtela ’ l pazjenti b’ mard attiv serju tas- sistema diġestiva.
Myfenax is an inosine monophosphate dehydrogenase (IMPDH) inhibitor.
Myfenax huwa impeditur ta ’ inosine monophosphate dehydrogenase (IMPDH).
On theoretical grounds, therefore, it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.
Għalhekk, fuq bażi teoretika, għandu jiġi evitat f’ pazjenti li għandhom defiċjenza ereditarja rari ta ’ hypoxanthine- guanine phosphoribosyl- transferase (HGPRT) bħal ma ’ huma s- sindromi Lesch- Nyhan u Kelley- Seegmiller.
It is recommended that Myfenax should not be administered concomitantly with azathioprine because such concomitant administration has not been studied.
Huwa rakkomandat li Myfenax ma jingħatax flimkien ma ’ azathioprine minħabba li l- għoti konkomittanti bħal dan ma ġiex studjat.
In view of the significant reduction in the AUC (area under the curve) of MPA by cholestyramine, caution should be used in the concomitant administration of Myfenax with medicinal products that interfere with enterohepatic recirculation because of the potential to reduce the efficacy of Myfenax.
In vista tat- tnaqqis sinifikattiv fl- AUC (erja taħt il- kurva) jew MPA minn cholestyramine, għandha tiġi użata l- kawtela fl- użu konkomitanti ta ’ Myfenax ma ’ prodotti mediċinali li jiddisturbaw iċ - ċirkulazzjoni mill- ġdid enteroepatika minħabba l- potenzjal li jnaqqas l- effikaċja ta ’ Myfenax.
Antacids with magnesium and aluminium hydroxides: absorption of mycophenolate mofetil was decreased when administered with antacids.
Antacids b’ magnesium u aluminium hydroxides: assorbiment ta ’ mycophenolate mofetil ġie mnaqqas meta mogħti ma ’ l- antacids.
Cholestyramine: following single dose administration 1.5 g of mycophenolate mofetil to normal healthy subjects pre-treated with 4 g three times a day (TID )of cholestyramine for 4 days, there was a 40% reduction in the AUC of MPA (see section 4.4 and section 5.2).
Cholestyramine: wara l- għoti ta ’ doża waħdanija ta ’ 1. 5 g ta ’ mycophenolate mofetil lil soġġetti normali f’ saħħithom li jkunu diġa ġew trattati b’ 4 g tliet darbiet kuljum (TID) ta ’ cholestyramine għal 4 ijiem, kien hemm tnaqqis ta ’ 40% fl- AUC (erja taħt il- kurva) ta ’ MPA (ara sezzjoni 4. 4: u sezzjoni 5. 2).
Caution should be used during concomitant administration because of the potential to reduce efficacy of Myfenax.
Għandha tintuża l- kawtela waqt l- għoti konkomitanti minħabba l- potenzjal li titnaqqas l - effikaċja ta ’ Myfenax.
4 Medicinal products that interfere with enterohepatic circulation: caution should be used with medicinal products that interfere with enterohepatic circulation because of their potential to reduce the efficacy of Myfenax.
Prodotti mediċinali li jfixklu ċ- ċirkulazzjoni enteroepatika: għandha tintuża l- kawtela bi prodotti mediċinali li jiddisturbaw iċ- ċirkulazzjoni enteroepatika minħabba l- potenzjal tagħhom li jnaqqsu l - effikaċja ta ’ Myfenax..
Ganciclovir; based on the results of a single dose administration study of recommended doses of oral mycophenolate and intravenous ganciclovir and the known effects of renal impairment on the pharmacokinetics of mycophenolate (see section 4.2) and ganciclovir, it is anticipated that co- administration of these agents (which compete for mechanisms of renal tubular secretion) will result in increases in MPAG and ganciclovir concentration.
Ganciclovir: ibbażat fuq ir- riżultati ta ’ stħarriġ b’ għoti ta ’ doża ewlenija tad- dożi rakkomandati ta ’ mycophenolate b’ mod orali u ganciclovir intravenuż u l- effetti magħrufa dwar l- indeboliment tal - kliewi fuq il- farmakokinetiċi ta ’ mycophenolate (ara sezzjoni 4. 2) u ganciclovir, huwa antiċipat li l- għoti konkomittanti ta ’ dawn iż- żewġ mediċini (li jikkompetu għall- mekaniżmi ta ’ tnixxija mit- tubuli tal - kliewi) tirriżulta f’ żidiet fil- konċentrazzjonijiet ta ’ MPAG u ganciclovir.
No substantial alteration of MPA pharmacokinetics is anticipated and mycophenolate mofetil dose adjustment is not required.
L- ebda tibdil sostanzjali ma huwa antiċipat u aġġustament tad- doża ta ’ Mycophenolate mofetil mhux meħtieġ.
In patients with renal impairment in which Myfenax and ganciclovir or its prodrugs, e. g. valganciclovir, are co-administered the dose recommendations for ganciclovir should be observed and patients monitored carefully.
F’ pazjenti b’ indeboliment tal- kliewi fejn Myfenax u ganciclovir jew il- prodrugs tagħha, eż. valganciclovir, huma mgħotijin konkomitantement ir- rakkomandazzjonijiet tad- doża għal ganciclovir għandhom jiġu osservati u l- pażjenti moniterjati bir- reqqa.
Rifampicin: in patients not also taking ciclosporin, concomitant administration of Mycophenolate mofetil and rifampicin resulted in a decrease in MPA exposure (AUC0-12h) of 18% to 70%.
Rifampicin: f’ pazjenti li mhux qed jieħdu wkoll ciclosporin, it- teħid konkomitanti ta ’ mycophenolate mofetil u rifamicin irriżulta fi tnaqqis fl- espożizzjoni għal MPA (AUC 1- 12h) ta ’ 18% sa 70%.
It is recommended to monitor MPA exposure levels and to adjust Myfenax doses accordingly to maintain clinical efficacy when rifampicin is administered concomitantly.
Huwa rakkomandat li l- livelli ta ’ espożizzjoni ta ’ MPA jiġu monitorati u sabiex id- dożi ta ’ Myfenax jiġu aġġustati skond dan sabiex tibqa ’ tiġi mantenuta l- effikaċja klinika meta rifampicin tiġi mogħtija ma ’ dan.
Sirolimus: in renal transplant patients, concomitant administration of mycphenolate mofetil and CsA resulted in reduced MPA exposures by 30-50% compared with patients receiving the combination of sirolimus and similar doses of Myfenax (see also section 4.4).
5 Sirolimus: f’ pazjenti li għandhom trapjant renali, it- teħid konkomitanti ta ’ mycophenolate mofetil u CsA irriżulta fi tnaqqis għal espożizzjonijiet għal MPA bi 30- 50% meta mqabbel ma ’ pazjenti li qed jirċievu kombinazzjoni ta ’ sirolimus u dożi simili ta ’ Myfenax (ara wkoll sezzjoni 4. 4).
Sevelamer: decrease in MPA Cmax and AUC by 30% and 25%, respectively, were observed when mycophenolate mofetil was concomitantly administered with sevelamer without any clinical consequences (i. e. graft rejection).
Sevelamer: tnaqqis f’ Cmax u AUC0- 12 ta ’ MPA bi 30% u 25% rispettivament kienu osservati meta mycophenolate mofetil kien mogħti flimkien ma ’ sevelamer mingħajr konsegwenzi kliniċi (i. e. riġettazzjoni tat- trapjant).
It is recommended, however, to administer Myfenax at least one hour before or three hours after sevelamer intake to minimise the impact on the absorption of MPA.
Madankollu, huwa rakkomandat li Myfenax jiġi mogħti ta ’ lanqas siegħa qabel jew tliet sigħat wara it- teħid ta ’ sevelamer biex jitnaqqas kemm jista ’ l- impatt ta ’ l- assorbiment ta ’ MPA.
There is no data on mycophenolate mofetil with phosphate binders other than sevelamer.
M’ hemmx tagħrif disponibbli dwar Mycophenolate mofetil ma ’ phosphate binders oħra li m’ humiex sevelamer.
Tacrolimus: in liver transplant recipients initiated on mycophenolate mofetil and tacrolimus, the AUC and Cmax of MPA, the active metabolite of mycophenolate mofetil, were not significantly affected by trough tacrolimus level.
Tacrolimus: f’ pazjenti bi trapjanti tal- fwied mibdija fuq mycophenolate mofetil u tacrolimus, l- AUC u Cmax ta ’ MPA, il- metabolit attiv ta ’ mycophenolate mofetil ma kienx affettwat b’ mod sinifikanti bil - livell lanqas baxx ta ’ tacrolimus.
However, in hepatic transplant patients, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of mycophenolate mofetil (1.5 g taken twice [BID] a day, morning and evening]) were administered to patients taking tacrolimus (see also section 4.4).
Madankollu, f’ pazjenti bi trapjant tal- fwied kien hemm żieda ta ’ madwar 20% fl- AUC ta ’ tacrolimus meta dożi multipli ta ’ mycophenolate mofetil (1. 5 g li għandhom jittieħdu darbtejn kuljum [BID] filgħodu u filgħaxija) ġew amministrati lil pazjenti li ħadu tacrolimus (ara wkoll sezzjoni 4. 4).
Other interactions: co-administration of probenecid with mycophenolate mofetil in monkeys raises plasma AUC of MPAG by 3-fold.
Interazzjonijiet oħrajn: l- għoti konkomitanti ta ’ probenicid ma ’ mycophenolate mofetil fix- xadini jgħolli l- plażma AUC ta ’ MPAG bi 3 darbiet.
5 Live vaccines: live vaccines should not be given to patients with an impaired immune response The antibody response to other vaccines may be diminished (see also section 4.4).
Ir- rispons ta ’ l- antikorp għall- vaċċini oħra jista ’ jkun imnaqqas (ara wkoll sezzjoni 4. 4).
It is recommended that Myfenax therapy should not be initiated until a negative pregnancy test has been obtained.
Huwa rakkomandat li t- terapija b’ Myfenax m’ għandiex tinbeda sakemm jinkiseb test tat- tqala neġattiv.
Effective contraception must be used before beginning Myfenax therapy, during therapy, and for six weeks following discontinuation of therapy (see section 4.5).
Kontraċezzjoni effettiva għandha tiġi wżata qabel tinbeda terapija b’ Myfenax, waqt it - terapija, u għal sitt ġimgħat wara li tintemm it- terapija (ara sezzjoni 4. 5).
The use of Myfenax is not recommended during pregnancy and should be reserved for cases where no more suitable alternative treatment is available.
L- użu ta ’ Myfenax mhux rakkomandat waqt it- tqala u għandu jiġi riżervat biss għal każijiet fejn m’ hemmx trattament adattat alternattiv disponibbli.
Myfenax should be used in pregnant women only if the potential benefit outweighs the potential risk to the foetus.
Fin- nisa tqal Myfenax għandu jiġi użat biss jekk il- benefiċċju potenzjali jkun akbar mir- riskju potenzjali għall- fetu.
There is limited data from the use of mycophenolate mofetil in pregnant women.
Hemm biss tagħrif ristrett dwar l - użu ta ’ mycophenolate mofetil f’ nisa tqal.
However, congenital malformations including ear malformations, i. e. abnormally formed or absent external/ middle ear have been reported in children of patients exposed to mycophenolate mofetil in combination with other immunosuppressants during pregnancy.
Madankollu, malformazzjonijiet konġenitali li jinkludu malformazzjonijiet tal- widna i. e żvilupp abnormali jew in- nuqqas ta ’ widna tan- nofs jew il- widna esterna ġew rapportati fi tfal ta ’ pazjenti esposti għal mycophenolate mofetil ma ’ immunosuppressanti oħra waqt it- tqala.
Because of the potential for serious adverse reactions to mycophenolate mofetil in breast-fed infants, Myfenax is contraindicated in breast-feeding mothers (see section 4.3).
Minħabba fir- riskju potenzjali għar - reazzjonijiet avversi serji għal mycophenolate mofetil fi trabi li jkunu mredda ’, Myfenax huwa kontra - indikat f’ ommijiet li jkunu qegħdin ireddgħu (ara sezzjoni 4. 3).