qanastek/EMEA-V3 huggingface dataset:
On 16 November 2006, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Mycograb 2 mg/ ml powder for solution for injection intended for the treatment of invasive candidiasis in adult patients, in combination with amphotericin B or a lipid formulation of amphotericin B.
Fis- 16 ta ’ Novembru 2006, il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) adotta opinjoni negattiva, u rrakkomanda r- rifjut ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq tal- prodott mediċinali Mycograb, trab għas- soluzzjoni għall- injezzjoni 2 mg/ ml, maħsub għat- trattament ta ’ kandidjasi invażiva f’ pazjenti adulti, f’ kombinazzjoni ma ’ amphotericin B jew formulazzjoni lipida ta ’ amphotericin B.
The company that applied for authorisation is NeuTec Pharma plc.
Il- kumpanija li applikat għall- awtorizzazzjoni hija NeuTec Pharma plc.
The applicant requested a re- examination of the opinion.
L- applikant talab għal eżaminazzjoni mill- ġdid ta ’ l- opinjoni.
After having considered the grounds for this request, the CHMP re- examined the initial opinion, and confirmed the refusal of the marketing authorisation on 20 March 2007.
Wara li kkunsidra r- raġuni għal din it- talba, is- CHMP eżamina mill- ġdid l- opinjoni tal- bidu, u kkonferma r- rifjut ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq fl- 20 ta ’ Marzu 2007.
What is Mycograb?
X’ inhu Mycograb?
Mycograb is a white powder that contains the active substance efungumab.
Mycograb huwa trab abjad li fih is- sustanza attiva efungumab.
The powder needs to be dissolved in sterile water before being injected into a vein.
It- trab jeħtieġ li jiġi maħlul fl- ilma sterili qabel ma jiġi injettat ġewwa vina.
What was Mycograb expected to be used for?
Għal x’ hiex huwa mistenni li jintuża Mycograb?
Mycograb was to be used together with amphotericin B (another antifungal medicine) to treat adult patients with invasive candidiasis.
Mycograb kien se jintuża ma ’ amphotericin B (mediċina oħra kontra l- fungi) biex jitratta pazjenti adulti b’ kandidjasi invażiva.
This disease is caused by infection with a common fungus (yeast) called Candida.
Din il- marda hija kkaġunata minn infezzjoni b’ fungu komuni (ħmira) msejħa Candida.
In invasive candidiasis, the fungal infection spreads to the internal organs such as the liver, spleen and kidneys via the bloodstream.
F’ kandidjasi invażiva, l- infezzjoni mill- fungu tinfirex għall- organi interni bħal ma huma l- fwied, il- milsa u l- kliewi minn ġon- nixxija tad- demm fil- ġisem.
Invasive candidiasis is a life-threatening disease..
Kandidjasi invażiva hija marda ta ’ periklu għall- ħajja.
Because the number of patients with invasive fungal infections is low, Mycograb was designated an ‘ orphan medicine’ (a medicine used in rare diseases) on 5 December 2001.
Minħabba li n- numru ta ’ pazjenti b’ infezzjonijiet invażivi bil- fungu huwa wieħed baxx, Mycograb ġie innominat bħala ‘ mediċina orfni ’ (mediċina li tintuża f’ mard rari) fil- 5 ta ’ Diċembru 2001.
How is Mycograb expected to work?
Kif huwa mistenni li jaħdem Mycograb?
The active substance in Mycograb, efungumab, is an antifungal agent.
Is- sustanza attiva f’ Mycograb, efunumab, hija mediċina kontra l- fungi.
It has been designed to attach to a specific protein on the surface of the fungal cells, called Heat Shock Protein 90 (hsp90).
Ġiet imfassla biex teħel ma ’ proteina speċifika fuq il- wiċċ taċ- ċelloli tal- fungi, imsejħa Heat Shock Protein 90 (hsp90).
This protein is involved in the formation and the repair of the cell wall and is essential for the survival of the fungal cells.
Din il - proteina hija involuta fil- formazzjoni u t- tiswija tal- membrana ċellulari u hija essenzjali għas - sopravivenza taċ- ċelloli tal- fungu.
By attaching to hsp90, efungumab blocks the protein’ s normal activities.
Enfungumab jimblokka l- attivitajiet normali tal- proteina billi jeħel ma ’ hsp90.
This weakens the cell wall, making the fungal cells fragile and unable to grow.
Dan idgħajjef il- ħajt taċ- ċellola, u jagħmel iċ- ċelloli tal- fungu fraġili u mingħajr ma jkunu jistgħu jikbru.
Efungumab is produced by a method known as ‘ recombinant DNA technology’.
Enfumag huwa magħmul b’ metodu magħruf bħala ‘ teknoloġija rekombinanti tad- DNA ’.
This means that it is made by a bacterium that has received a gene (DNA), which makes it able to produce the substance.
Din tfisser li huwa magħmul minn batterju li rċieva ġene (DNA), li tagħmlu kapaċi li jagħmel is- sustanza.
What documentation did the company present to support its application to the CHMP?
X’ dokumentazzjoni ppreżentat il- kumpanija biex tappoġġja l- applikazzjoni tagħha lis- CHMP?
The effects of Mycograb were first tested in experimental models before being studied in humans.
Qabel ma ġew studjati fil- bnedmin, l- effetti ta ’ Mycograb ġew l- ewwel ittestjati f’ mudelli esperimentali.
The main study of the medicine’ s effects involved 139 adults with invasive candidiasis.
L- istudju ewlieni ta ’ l- effetti tal- mediċina involva 139 adult b’ kandidjasi invażiva.
The study compared the effects of Mycograb to those of a placebo (a dummy treatment), when they were given with amphotericin B for 5 days.
L- istudju qabbel l - effetti ta ’ Mycograb ma ’ dawk ta ’ plaċebo (trattament finta), meta ngħataw ma ’ amphotericin B għal 5 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
The effectiveness was measured by looking at the percentage of patients responding to treatment, based on improvement of their symptoms (including fever) and elimination of the fungus from samples, as measured on day 10 (5 days after the end of Mycograb or placebo treatment).
L- effikaċja ġiet imkejjla b’ kunsiderazzjoni tal- perċentwali ta ’ pazjenti li rrispondew għat - trattament, fuq il- bażi tat- titjib tas- sintomi tagħhom (inkluż deni) u eliminazzjoni tal- fungu mill - kampjuni, kif imkejla f’ jum 10 (5 ijiem wara t- trattament b’ Mycograb jew bi plaċebo).
(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 What were the major concerns that led the CHMP to recommend the refusal of the marketing authorisation?
X’ kienu t- tħassib maġġuri li wasslu lis- CHMP biex jirrikmanda r- rifjut ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq?
In November 2006, the CHMP was concerned about some aspects of the quality of the medicine (such as the way the molecules of efungumab may fold or aggregate in the solution for injection and the level of some substances that could stimulate an immune response in patients).
F’ Novembru 2006, is- CHMP kien imħasseb fuq xi aspetti tal- kwalità tal- mediċina (bħalma huwa l - mod kif il- molekuli ta ’ Mycograb jistgħu jintlewew jew jaggregaw fis- soluzzjoni għall- injezzjoni u l - livell ta ’ xi sustanzi li jistgħu jistimulaw reazzjoni immuni fil- pazjenti).
It also had concerns about the safety of Mycograb.
Kien imħasseb ukoll fuq is - sigurtà ta ’ Mycograb.
The medicine is associated with ‘ cytokine release syndrome’, a condition that can cause nausea, vomiting, pain and also hypertension (high blood pressure), but the reason for this is not clear.
Il- mediċina hija assoċjata ma ’ ‘ sindromu ta ’ liberazzjoni ta ’ ċitokini ’, kondizzjoni li tista ’ tikkaġuna dardir, rimettar, uġigħ u anke pressjoni għolja, imma r- raġuni għal dan mhix ċara.
Too few patients have received Mycograb for its safety to be sufficiently assessed.
Ftit wisq pazjenti ngħataw Mycograb sabiex is- sigurtà tiegħu tkun evalwata biżżejjed.
In March 2007, following the re-examination, the CHMP removed their concern regarding the cytokine release syndrome and hypertension, as these would be manageable in clinical practice.
F’ Marzu 2007, wara eżaminazzjoni mill- ġdid, is- CHMP neħħa t- tħassib tiegħu dwar is- sindromu ta ’ liberazzjoni taċ- ċitokini u l- pressjoni għolja, minħabba li dawn ikunu maniġġevoli fil- prattika klinika.
However, all other concerns remain.
Madankollu, it- tħassib l- ieħor kollu jibqa ’.
At this point in time, the committee was of the opinion that the benefits of Mycograb in the treatment of invasive candidiasis did not outweigh its risks.
F’ dan il- waqt, il- kumitat kien ta ’ l- opinjoni li l- benefiċċji ta ’ Mycograb fit- trattament ta ’ kandidjasi invażiva ma jisbqux ir- riskji tiegħu.
Hence, the CHMP recommended that Mycograb be refused marketing authorisation.
Għalhekk, is- CHMP irrikmanda li Mycograb jiġi mċaħħad minn awtorizzazzjoni għat- tqegħid fis- suq.
What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Mycograb?
X’ inhuma l- konsegwenzi tar- rifjut għal pazjenti fi provi kliniċi jew fi programmi ta ’ użu ta ’ kompassjoni li jużaw Mycograb?
The company informed the CHMP that there are no consequences on patients currently included in clinical trials or compassionate use programmes with Mycograb.
Il- kumpanija informat lis- CHMP li ma hemm l- ebda konsegwenzi fuq pazjenti bħalissa inklużi fi provi kliniċi jew programmi ta ’ użu ta ’ kompassjoni b’ Mycograb.
If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Jekk inti qiegħed fi prova klinika jew programm ta ’ użu ta ’ kompassjoni u teħtieġ aktar tagħrif dwar it- trattament tiegħek, ikkuntattja lit - tabib li qiegħed jagħtihulek.
What is Mycophenolate mofetil Teva?
X’ inhu l- Mycophenolate Mofetil Teva?
Mycophenolate mofetil Teva is a medicine containing the active substance mycophenolate mofetil.
Mycophenolate Mofetil Teva hija mediċina li fiha s- sustanza attiva mycophenolate mofetil.
It is available as capsules (250 mg) and tablets (500 mg).
Huwa disponibbli f’ forma ta ’ kapsuli (250 mg) u ta ’ pilloli (500 mg).
Mycophenolate mofetil Teva is a ‘ generic medicine’.
Mycophenolate Mofetil Teva hija ‘ mediċina ġenerika ’.
For more information on generic medicines, see the question-and-answer document here.
Dan ifisser li Mycophenolate Mofetil Teva hija simili għall - ‘ mediċina ta ’ referenza ’ diġa awtorizzata fl- Unjoni Europea (UE) li jisimha CellCept. http: // www. emea. europa. eu/ pdfs/ human/ pcwp/ 39390506en. pdfGħall- aktar informazzjoni dwar il - mediċini ġeneriċi, ara id- dokument mistoqsija- u- tweġiba hawn.
What is Mycophenolate mofetil Teva used for?
Għal xiex tintuża l- Mycophenolate Mofetil Teva?
Mycophenolate mofetil Teva is used to prevent the body from rejecting a transplanted kidney, heart or liver.
Mycophenolate Mofetil Teva hija wżata sabiex tipprevjeni milli l- ġisem jiċħad trapjant ta ’ kilwa, qalbe jew fwied.
It is used with ciclosporin and corticosteroids (other medicines used to prevent organ rejection).
Hija wżata flimkien ma ’ ciclosporin u kortikosterojdi (mediċini oħrajn użati sabiex jipprevjenu tiċħid ta ’ organu).
How is Mycophenolate mofetil Teva used?
Kif tintuża l- Mycophenolate Mofetil Teva?
Mycophenolate mofetil Teva treatment should be initiated and maintained by a qualified transplant specialist.
Trattament bil- Mycophenolate Mofetil Teva għandu jinbeda u jitkompla minn speċjalista kwalifikat fit- trapjanti.
The way that Mycophenolate mofetil Teva should be given and the dose depend on the type of organ transplant and the patient ’ s age and size.
Il- mod ta ’ kif Mycophenolate Mofetil Teva għandha tingħata u d- doża tiddependi mit- tip ta ’ organu li jiġi trapjantat u l- 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.
F’ każijiet ta ’ trapjant tal- kliewi d- doża rakkomandata f’ adulti hija ta ’ 1. 0 g darbtejn kuljum li tibda 72 siegħa wara t- trapjant.
In children aged between two and 18 years, the dose of Mycophenolate mofetil Teva is calculated depending on height and weight.
Id- doża ta ’ Mycophenolate Mofetil Teva għal tfal ta ’ bejn sentejn u t- 18 – il sena hija kalkulata 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.
F’ każ ta ’ trapjant tal- qalb id- doża rakkommandata għall- adulti hija ta ’ 1. 5 g darbtejn kuljum, li jinbdew 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 Mycophenolate mofetil Teva twice a day as soon as it can be tolerated.
F’ każ ta ’ trapjanti tal- fwied f’ adulti, għandu jingħata mycophenolate mofetil bħala infużjoni (bid - dripp fil- vina) għall- ewwel erbat ijiem wara t- trapjant, qabel ma ’ l- pazjent jista ’ jingħata 1. 5 g ta ’ Mycophenolate mofetil Teva darbtejn kuljum hekk kif din tista ’ tiġi tollerata mill- pazjent.
Mycophenolate mofetil Teva is not recommended for use in children after heart or liver transplants because of a lack of information on its effects in this group.
Mycophenolate mofetil Teva mhijiex rakkommandata għal użu fit- tfal wara trapjanti tal- qalb jew tal - fwied minħabba nuqqas ta ’ informazzjoni dwar l- effetti tagħha f’ dan il- grupp.
The dose may need to be adjusted in patients with liver or kidney disease.
Id- doża tista ’ tkun aġġustata skond il- bżonn f’ pazjenti b’ mard tal- fwied jew tal- kliewi.
(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 enzyme called ‘ inosine monophosphate dehydrogenase’.
Is- sustanza attiva Mycophenolate mofetil Teva, mycophenolate mofetil hija mediċina immunosuppressive.
This enzyme is important for the formation of DNA in cells, particularly in the lymphocytes (a type of white blood cell which is involved in the rejection of organ transplants).
Din l- enzima hija importanti għal formazzjoni ta ’ ċelloli tad- DNA, b’ mod partikolari l- linfoċiti (tip ta ’ ċelloli bojod tad- demm li huma involuti fit- tiċħid ta ’ trapjanti ta ’ organu).
By preventing the production of new DNA, Mycophenolate mofetil Teva reduces the rate at which the lymphocytes multiply.
Mycophenolate mofetil Teva inaqqas ir- rata li bih jimmultiplikaw il- linfoċiti billi tippreveni l- produzzjoni ta ’ DNA ġdida.
This makes them less effective at recognising and attacking the transplanted organ, lowering the risk of the organ being rejected.
Dan iwassal sabiex ikunu anqas effettivi fl- għarfien u l- attakk ta ’ organu trapjantat, tnaqqis tar- riskju ta ’ tiċħid ta ’ l- organu.
How has Mycophenolate mofetil Teva been studied?
Kif ġiet studjata Mycophenolate mofetil Teva?
Because Mycophenolate mofetil Teva 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).
Minħabba li Mycophenolate mofetil Teva hija mediċina ġenerika, l- istudji ġew limitati għal testijiet biex jintwera li hija bijoekwivalenti għall- mediċini ta ’ referenza (huma jipproduċu l- istess livelli ta ’ sustanza attiva fil- ġisem).
What are the benefit and risk of Mycophenolate mofetil Teva?
X’ inhu l- benefiċċju u r- riskju ta ’ Mycophenolate mofetil Teva?
Because Mycophenolate mofetil Teva 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.
Minħabba li Mycophenolate mofetil Teva hija mediċina ġenerika u bijoekwivalenti għall- mediċini ta ’ referenza, il- benefiċċju u r- riskju tagħha huma meqjusa li huma analogi għal dawk tal- mediċini ta ’ referenza.
Why has Mycophenolate mofetil Teva been approved?
Għaliex ġiet approvata Mycophenolate mofetil Teva?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Mycophenolate mofetil Teva has been shown to have comparable quality and to be bioequivalent to Cellcept.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li, b’ mod konformi mal- ħtiġijiet ta ’ l- UE, ġie muri li Mycophenolate mofetil Teva għandha kwalità komparabbli ma ’ u li hija bijoekwivlenti għal CellCept.
Therefore, the CHMP’ s view was that, as for CellCept, the benefit outweighs the identified risk.
Għaldaqstant, il- fehma tas- CHMP kienet li, bħal f’ CellCept, il - benefiċċji jegħlbu r- riskji identifikati.
The Committee recommended that Mycophenolate mofetil Teva be given marketing authorisation.
Il- Kumitat irrakkomanda li Mycophenolate mofetil Teva tingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Mycophenolate mofetil Teva:
Informazzjoni ulterjuri dwar Mycophenolate mofetil Teva:
The European Commission granted a marketing authorisation valid throughout the EU for Mycophenolate mofetil Teva to Teva Pharma B. V. on 21 February 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Mycophenolate mofetil Teva valida fl- Unjoni Ewropea kollha lil Teva Pharma BV fil- 21 ta ’ Frar 2008.
The full EPAR for Mycophenolate mofetil Teva can be found here.
http: // www. emea. europa. eu/ humandocs/ Humans/ EPAR/ mycophenolatemofetilteva/ mycophenolatemo fetilteva. htmL- EPAR sħiħ għal Mycophenolate mofetil Teva jista ’ jinstab hawnhekk.
The full EPAR for the reference medicine can also be found on the EMEA’ s website.
L- EPARs sħaħ għall- mediċina ta ’ referenza jista ’ jinstab fuq il- websajt ta ’ l- EMEA ukoll.
This summary was last updated in 01-2008.
Dan is- sommarju kien approvat l- aħħar f’ 01- 2008.
EU/ 1/ 07/ 439/ 001 EU/ 1/ 07/ 439/ 002 EU/ 1/ 07/ 439/ 003 EU/ 1/ 07/ 439/ 004
Numru ta ’ l- UE EU/ 1/ 07/ 439/ 001 EU/ 1/ 07/ 439/ 002 EU/ 1/ 07/ 439/ 003 EU/ 1/ 07/ 439/ 004
Mycophenolate mofetil Teva Mycophenolate mofetil Teva Mycophenolate mofetil Teva Mycophenolate mofetil Teva
Isem inventat Mycophenolate mofetil Teva Mycophenolate mofetil Teva Mycophenolate mofetil Teva Mycophenolate mofetil Teva
250 mg 250 mg 500 mg 500 mg
Qawwa 250 mg 250 mg 500 mg 500 mg
Capsule, hard Capsule, hard Film-coated tablet Film-coated tablet
Għamla farmaċewtika Kapsula, iebsa Kapsula, iebsa Pillola miksija b’ rita Pillola miksija b’ rita
Oral use Oral use Oral use Oral use
Mnejn jingħata Jittieħed mill- ħalq Jittieħed mill- ħalq Jittieħed mill- ħalq Jittieħed mill- ħalq
blister (PVC/ PVDC/ alu) blister (PVC/ PVDC/ alu) blister (PVC/ PVDC/ alu) blister (PVC/ PVDC/ alu)
Il- pakkett folja (PVC/ PVDC/ alu) folja (PVC/ PVDC/ alu) folja (PVC/ PVDC/ alu) folja (PVC/ PVDC/ alu)
100 capsules 300 capsules 50 tablets 150 tablets
Daqs tal- pakkett 100 kapsula 300 kapsula 50 pillola 150 pillola
Mycophenolate mofetil Teva 250 mg hard capsules
Mycophenolate mofetil Teva 250 mg kapsuli iebsin
Excipient For a full list of excipients, see section 6.1
Sustanza mhix attiva Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1
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.
Mycophenolate mofetil Teva is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva should be initiated and maintained by appropriately qualified transplant specialists.
Trattament b’ Mycophenolate mofetil Teva għandu jiġi mibdi u mantenut minn speċjalisti kwalifikati xierqa fit- trapjanti.
Adults: oral Mycophenolate mofetil Teva should be initiated within 72 hours following transplantation.
Mycophenolate mofetil Teva mogħti mill- ħalq għandu jiġi mibdi fi żmien 72 siegħa minna wara t- trapjant.
The recommended dose in renal transplant patients is 1.0 g administered twice daily (2 g daily dose).
Id- doża rakkomandata f’ pazjenti bi trapjant tal- kliewi hi ta ’ 1. 0 g li tingħata darbtejn kuljum (doża ta ’ 2 g kuljum).
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). Mycophenolate mofetil Teva capsules should only be prescribed to patients with a body surface area of at least 1.25 m2.
Pazjenti b’ erja superfiċjali korporali ta ’ bejn 1. 25- 1. 5 m2 għandhom jiġu ppreskritti l- kapsuli Mycophenolate mofetil Teva f’ doża ta ’ 750 mg darbtejn kuljum (doża ta’ 1. 5 g kuljum).
Patients with a body surface are of 1.25 to 1.5 m2 may be prescribed Mycophenolate mofetil Teva capsules at a dose of 750 mg twice daily (1.5 g daily dose).
Pazjenti b ’ erja superfiċjali korporali akbar minn 1. 5 m2 għandhom jiġu ppreskritti l- kapsuli Mycophenolate mofetil Teva f’ doża ta ’ 1 g darbtejn kuljum (doża ta ’ 2 g kuljum).
Patients with a body surface area greater than 1.5 m2 may be prescribed Mycophenolate mofetil Teva capsules at a dose of 1 g twice daily (2 g daily dose). 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.
Children (< 2 years): there are limited safety and efficacy data in children below the age of 2 years.
Tfal (< Sentejn): hemm biss tagħrif ristrett dwar is- sigurtà u l- effikaċja ta ’ tfal ta ’ taħt is- sentejn.
These are insufficient to make dose 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.
Use in cardiac transplant:
Użu fi trapjanti kardijaċi:
2 Adults: oral Mycophenolate mofetil Teva should be initiated within 5 days following transplantation.
Mycophenolate mofetil Teva mogħti mill- ħalq għandu jiġi mibdi fi żmien 5 ijiem wara t - trapjant.
The recommended dose in cardiac transplant patients is 1.5 g administered twice daily (3 g daily dose).
Id- doża rakkomandata f’ pazjenti bi trapjant kardijaku hi ta ’ 1. 5 g li tingħata darbtejn kuljum (doża ta ’ 3 g kuljum).
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.
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 Mycophenolate mofetil Teva 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 ’ Mycophenolate mofetil Teva li tkun ittollerata li tinbeda kemm jista ’ jkun malajr wara dan.
The recommended oral dose in hepatic transplant patients is 1.5 g administered twice daily (3 g daily dose).
Id- doża orali rakkomandata f’ pazjenti bi trapjant tal- fwied hija ta ’ 1. 5 g li tingħata darbtejn kuljum (doża ta ’ 3 g kuljum).
Children and adolescents: no data are available for paediatric hepatic transplant patients, therefore use in this patients group is not recommended until further data to support this is available.
Tfal u adoloxxenti: l- ebda tagħrif ma hu disponibbli għal pazjenti pedjatri bi trapjant tal- fwied, għalhekk l- użu f’ dan il- grupp ta ’ pazjenti mhux rakkomandat sakemm ikun hemm aktar tagħrif li jappoġġja dan.
Use in elderly ( 65 years)
Użu fl- anzjani (≥ 65 sena)
The recommended dose of 1.0 g administered twice a day for renal transplant patients and 1.5 g twice a day for cardiac or hepatic transplant patients is appropriate for the elderly.
Id- doża rakkomandata ta ’ 1. 0 g li tingħata darbtejn kuljum għal pazjenti bi trapjanti tal- kliewi u 1. 5 g darbtejn kuljum għal pazjenti bi trapjanti kardijaċi jew tal- fwied huma adattati għall- anzjani.
Use in renal impairment
Użu f’ indeboliment tal- kliewi
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.
These patients should also be carefully observed.
Dawn il- pażjenti għandhom ukoll jiġu osservati bir- reqqa.
No dose adjustments are needed in patients experiencing delayed renal graft function post-operatively (see section 5.2).
L- ebda tibdil fid- dożi ma huwa meħtieġ f’ pazjenti li jkollhom dewmien fil - funzjoni tal- graft renali wara l- operazzjoni (Ara sezzjoni 5. 2).
No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment.
M’ hemm l- ebda dejta fuq pazjenti bi trapjanti tal- qalb u tal- fwied b’ indeboliment kroniku sever tal- kliewi.
Use in severe hepatic impairment
Użu f’ indeboliment tal- fwied sever
No dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease.
L- ebda aġġustament tad- doża mhu meħtieġ għal pazjenti bi trapjant tal- kliewi li għandu marda parenkimali epatika severa.
No data are available for cardiac transplant patients with severe hepatic parenchymal disease.
M’ hemm l- ebda tagħrif disponibbli għal pazjenti bi trapjant kardijaku b’ marda parenkimali epatika severa.
Treatment during rejection episodes
Trattament waqt episodji ta ’ tiċħid:
Mycophenolic acid (MPA) is the active metabolite of mycophenolate mofetil.
Mycophenolic acid (MPA) huwa l- metabolit attiv ta ’ mycophenolate mofetil.
Renal transplant rejection does not lead to changes in MPA pharmacokinetics; dose reduction or interruption of Mycophenolate mofetil Teva is not required.
Tiċħid tat- trapjant tal - kliewi ma jwassalx għal tibdil fil- farmakokinetiċi ta ’ MPA; tnaqqis fid- doża jew twaqqif ta ’ Mycophenolate mofetil Teva mhux meħtieġ.
There is no basis for Mycophenolate mofetil Teva dose adjustment following cardiac transplant rejection.
Ma hemm l- ebda bażi għal aġġustament fid- doża ta ’ Mycophenolate mofetil Teva wara trapjant tal- qalb riġettat.
No pharmacokinetic data are available during hepatic transplant rejection.
Ma hemm l- ebda dejta farmakokinetika waqt tiċħid ta ’ trapjant tal- fwied.
Hypersensitivity 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
Mycophenolate mofetil Teva is contraindicated in women who are breast-feeding (see section 4.6).
Mycophenolate mofetil Teva huwa kontra- indikat f’ nisa li qed ireddgħu (ara sezzjoni 4. 6).
As general advice to
Ir- riskju jidher li huwa aktar relatat ma ’ l- intensità u t- tul ta ’ l- immunosoppressjoni milli mill- użu ta ’ xi mediċina speċifika.
3 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 vjola (UV) għandu jkun ristrett billi jintlibsu ħwejjeġ protettivi u billi jintuża sunskrin b’ fattur ta ’ protezzjoni għoli.
Patients receiving Mycophenolate mofetil Teva should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression.
Pazjenti li jirċievu Mycophenolate mofetil Teva għandhom jiġu mogħtija istruzzjonijiet biex jirraportaw minnufih kull evidenza ta ’ infezzjoni, tbenġil mhux mistenni, fsada jew xi manifestazzjoni oħra ta ’ dipressjoni tal- mudullun.
Patients treated with immunosuppressants, including Mycophenolate mofetil Teva, 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 Mycophenolate mofetil Teva, 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 Mycophenolate mofetil Teva should be monitored for neutropenia, which may be related to Mycophenolate mofetil Teva itself, concomitant medicinal products, viral infections, or some combination of these causes.
Pazjenti li jirċievu Mycophenolate mofetil Teva għandhom jiġu sorveljati għan- newtropenja, li tista ’ tkun relatata ma ’ Mycophenolate mofetil Teva innifsu, prodotti mediċinali konkomitanti, infezzjonijiet minn vajrusis, jew xi kumbinazzjoni ta ’ dawn il- kawżi.
Patients taking Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva 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/ l) it may be appropriate to interrupt or discontinue Mycophenolate mofetil Teva.
Jekk tiżviluppa n- newtropenija (għadd ta ’ newtrofils assolut < 1. 3 103/ µl) jkun aħjar li Mycophenolate mofetil Teva jiġi interrot jew imwaqqaf.
Patients should be advised that during treatment with Mycophenolate mofetil Teva 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’ Mycophenolate mofetil Teva, il- vaċċinazzjonijiet jistgħu jkunu anqas effettivi u l- użu ta ’ vaċċini ħajjin imma attenwati għandhom jiġu evitati (ara sezzjoni 4. 5).
Influenza vaccination may be of value.
Il- vaċċin kontra l- influwenza jista ’ jkun ta ’ siwi.
Prescribers should refer to national guidelines for influenza vaccination.
Dawk li jippreskrivu għandhom jirreferu għall- gwidi nazzjonali tat- tilqim kontra l- influwenza.
Because mycophenolate has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation, Mycophenolate mofetil Teva 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, Mycophenolate mofetil Teva għandu jiġi mgħoti b’ kawtela ’ l pazjenti b’ mard attiv serju tas- sistema diġestiva.
Mycophenolate mofetil Teva is an inosine monophosphate dehydrogenase (IMPDH) inhibitor.
Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva should not be administered concomitantly with azathioprine because such concomitant administration has not been studied.
4 Huwa rakkomandat li Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva with medicinal products that interfere with enterohepatic recirculation because of the potential to reduce the efficacy of Mycophenolate mofetil Teva.
In vista tat- tnaqqis sinifikattiv fl- AUC (erja taħt il- kurva) jew MPA minn cholestyramine, għandha tiġi użata l- kawtela fl- użu konkomitanti ta ’ Mycophenolate mofetil Teva ma ’ prodotti mediċinali li jiddisturbaw iċ- ċirkulazzjoni mill- ġdid enteroepatika minħabba l- potenzjal li jnaqqas l- effikaċja ta ’ Mycophenolate mofetil Teva.
The risk-benefit ratio of mycophenolate mofetil in combination with tacrolimus or sirolimus has not been established (see also section 4.5).
Il- proporzjon dwar ir- riskju għal benefiċċju ta ’ teħid ta mycophenolate mofetil ma ’ tacrolimus jew sirolimus għadu ma ġiex stabbilit (ara wkoll sezzjoni 4. 5).
Aciclovir: higher aciclovir plasma concentrations were observed when mycophenolate mofetil was administered with aciclovir in comparison to the administration of aciclovir alone.
Aciclovir: konċentrazzjonijiet ogħla fil- plażma ta ’ aciclovir kienu osservati meta mycophenolate mofetil kien mogħti ma ’ aciclovir meta mqabbel ma ’ l- għoti ta ’ aciclovir waħdu.
The changes in MPAG (the phenolic glucuronide of MPA) pharmacokinetics (MPAG increased by 8%) were minimal and are not considered clinically significant.
It- tibdiliet fil - farmakokinetiċi MPAG (phenolic glucuronide ta ’ MPA) (MPAG tiżdied bi 8%) huma minimi u mhumiex ikkunsiderati klinikament sinifikattivi.
Because MPAG plasma concentrations are increased in 4 the presence of renal impairment, as are aciclovir concentrations, the potential exists for mycophenolate mofetil and aciclovir, or its prodrugs, e. g. valaciclovir, to compete for tubular secretion and further increases in concentrations of both substances may occur.
Peress li konċentrazzjonijiet fil- plażma ta ’ MPAG jiżdiedu fil- preżenza ta ’ indeboliment tal- kliewi, kif jiġri lill- konċentrazzjonijiet ta ’ aciclovir, jeżisti l - potenzjal għal mycophenolate mofetil u aciclovir, jew il- prodrugs tiegħu, eż. valaciclovir, li jikkompetu għat- tnixxija tubulari u jista ’ jkun hemm aktar żidiet fil- konċentrazzjonijiet taż- żewġ sustanzi.
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 mogħtiha 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 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 mycophenolate mofetil.
Għandha tintuża l- kawtela waqt l- għoti konkomitanti minħabba l- potenzjal li titnaqqas l- effikaċja ta ’ mycophenolate mofetil.
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 mycophenolate mofetil.
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 ’ mycophenolate mofetil
Ciclosporin A: ciclosporin A (CsA) pharmacokinetics were unaffected by mycophenolate mofetil.
Ciclosporin A: il- farmakokinetiċi ta ’ ciclosporin A (CsA) ma kienux affettwati b’ mycophenolate mofetil.
In contrast, if concomitant ciclosporin treatment is stopped, an increase in MPA AUC of around 30% should be expected.
Mill- banda l- oħra, jekk it trattatment konkomitanti b’ ciclosporin jiġi mwaqqaf, huwa mistenni li jkun hemm żieda ta ’ madwar 30% fl- AUC ta ’ MPA.
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 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 Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva 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.
Oral contraceptives: the pharmacokinetics and pharmacodynamics of oral contraceptives were unaffected by co-administration of mycophenolate (see also section 5.2).
5 Kontraċettivi orali: il- farmakokinetiċi u l- farmakodinamiċi ta ’ kontraċettivi orali ma kinux effettwati mill- għoti konkomitanti ta ’ mycophenolate (ara wkoll sezzjoni 5. 2).
Rifampicin: in patients not also taking ciclosporin, concomitant administration of Mycophenolate mofetil and rifampicin resulted in a decrease in MPA exposure (AUC 0-12h) of 18% to 70%. It is recommended to monitor MPA exposure levels and to adjust Mycophenolate mofetil Teva 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 ’ Mycophenolate mofetil Teva 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 mycophenolate mofetil and CsA resulted in reduced MPA exposures by 30-50% compared with patients receiving the combination of sirolimus and similar doses of mycophenolate mofetil (see also section 4.4).
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 ’ Mycophenolate mofetil Teva (ara wkoll sezzjoni 4. 4).
Sevelamer: decrease in MPA C max and AUC 0-12 by 30% and 25%, respectively, were observed when mycophenolate mofetil was concomitantly administered with sevelamer without any clinical consequences (i. e. graft rejection). It is recommended, however, to administer Mycophenolate mofetil Teva at least one hour before or three hours after sevelamer intake to minimise the impact on the absorption of MPA.
Madankollu, huwa rakkomandat li Mycophenolate mofetil Teva 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.
Trimethoprim/ sulfamethoxazole: no effect on the bioavailability of MPA was observed.
Trimethoprim/ sulfamethoxazole: l- ebda effett fuq il- bijodisponibilità ta ’ MPA ma ġiet osservata.
Norfloxacin and metronidazole: in healthy volunteers, no significant interaction was observed when mycophenolate mofetil was concomitantly administered with norfloxacin and metronidazole separately.
Norfloxacin u metronidazole: f’ voluntiera b’ saħħithom, ma kienet osservata ebda interazzjoni sinifikanti meta mycophenolate mofetil ġie mogħti flimkien ma ’ norfloxacin u metronidazole separatament.
However, norfloxacin and metronidazole combined reduced the MPA exposure by approximately 30% following a single dose of mycophenolate mofetil.
Madankollu, norfloxacin u metronidazole flimkien naqqsu l- espożizzjoni għal MPA b’ madwar 30% wara doża waħda ta ’ mycophenolate mofetil.
5 Tacrolimus: in liver transplant recipients initiated on mycophenolate mofetil and tacrolimus, the AUC and C max 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.
In renal transplant patients, the tacrolimus concentration did not appear to be altered by mycophenolate mofetil.
F’ pazjenti bi trapjant renali, il- konċentrazzjoni ta ’ tacrolimus ma dehritx li kienet mibdula b’ mycophenolate mofetil.
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 a day [BID], 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. Thus, other substances known to undergo renal tubular secretion may compete with MPAG and thereby raise plasma concentrations of MPAG or the other substance undergoing tubular secretion.
Għalhekk, sustanzi oħra li jnixxu mit- tubuli tal- kliewi jistgħu jikkompetu ma ’ MPAG u b’ hekk jgħollu l- konċentrazzjonijiet fil- plażma ta ’ MPAG jew ta ’ sustanza li tkun qed tnixxi mit- tubuli.
Live vaccines: live vaccines should not be given to patients with an impaired immune response.
Vaċċini ħajjin: vaċċini ħajjin m’ għandhomx jingħataw lill- pazjenti b’ rispons immunitarju mhux sħiħ.
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 Mycophenolate mofetil Teva therapy should not be initiated until a negative pregnancy test has been obtained.
Huwa rakkomandat li t- terapija b’ Mycophenolate mofetil Teva m’ għandiex tinbeda sakemm jinkiseb test tat- tqala neġattiv.
Effective contraception must be used before beginning mycophenolate mofetil therapy, during therapy, and for six weeks following discontinuation of therapy (see section 4.5). Patients should be instructed to consult their physician immediately should pregnancy occur.
Pazjenti għandhom jingħataw parir biex jikkonsultaw mat- tabib tagħhom hekk kif jinqabdu tqal.
The use of Mycophenolate mofetil Teva is not recommended during pregnancy and should be reserved for cases where no more suitable alternative treatment is available.
L- użu ta ’ Mycophenolate mofetil Teva mhux rakkomandat waqt it- tqala u għandu jiġi riżervat biss għal każijiet fejn m’ hemmx trattament adattat alternattiv disponibbli.
Mycophenolate mofetil Teva should be used in pregnant women only if the potential benefit outweighs the potential risk to the foetus.
Fin- nisa tqal Mycophenolate mofetil Teva 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, 6 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.
Cases of spontaneous abortions have been reported in patients exposed to mycophenolate mofetil.
Każijiet ta ’ abort spontanju ġew irrapportati f’ pazjenti esposti għal mycophenolate mofetil.
Studies in animals have shown reproductive toxicity (see section 5.3).
Studji fl- annimali wrew tossiċità reproduttiva (ara sezzjoni 5. 3).
Mycophenolate mofetil has been shown to be excreted in the milk of lactating rats.
Mycophenolate mofetil ġie muri li jiġi eliminat fil- ħalib ta ’ firien li jkunu qegħdin ireddgħu.
It is not known whether this substance is excreted in human milk.
Mhux magħruf jekk din is- sustanza tiġiex eliminata fil- ħalib uman.
Because of the potential for serious adverse reactions to mycophenolate mofetil in breast-fed infants, Mycophenolate mofetil Teva 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 ’, Mycophenolate mofetil Teva huwa kontra- indikat f’ ommijiet li jkunu qegħdin ireddgħu (ara sezzjoni 4. 3).
The pharmacodynamics profile and the reported adverse reactions indicate that an effect is unlikely.
Il- profil farmakodinamiku u r- reazzjonijiet avversi rraportati jindikaw li effett mhux probabbli li jseħħ.
The following undesirable effects cover adverse reactions from clinical trials:
L- effetti mhux mixtieqa li ġejjin ikopru reazzjonijiet avversi tal- mediċina minn provi kliniċi:
The principal adverse reactions associated with the administration of mycophenolate in combination with ciclosporin and corticosteroids include diarrhoea, leucopenia, sepsis and vomiting and there is evidence of a higher frequency of certain types of infections (see section 4.4).
Ir- reazzjonijiet avversi prinċipali assoċjati ma’ l- amministrazzjoni ta ’ mycophenolate flimkien ma ’ ciclosporin u corticosteroids jinkludu dijarrea, lewkopenija, sepsis u remettar u hemm evidenza ta ’ frekwenza ogħla ta ’ ċertu tipi ta ’ infezzjonijiet (ara sezzjoni 4. 4).
Malignancies:
Mard malinn:
Patients receiving immunosuppressive regimens involving combinations of medicinal products, including mycophenolate, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section 4.4).
Pazjenti li jkunu fuq reġimens immunosoppressivi li jinvolvu kumbinazzjonijiet ta ’ prodotti mediċinali inkluż mycophenolate, huma f’ riskju akbar li jiżviluppaw limfomi u mard malinn ieħor, partikolarment tal- ġilda (ara sezzjoni 4. 4).