qanastek/EMEA-V3 huggingface dataset:
Carglumic acid was shown to decrease blood ammonia levels and increase urea levels in blood and urine, whereas the liver content of carbamoyl phosphate synthetase activators was significantly increased.
Instab li carglumic acid jnaqqas il- livelli ta ’ ammonja fid- demm u jżid il- livelli ta ’ l- urea fid- demm u fl- awrina, filwaqt li l- kontenut ta’ attivaturi ta ’ carbamoyl phosphate synthetase fil- kliewi żdied b’ mod sinifikanti.
In patients with N-acetylglutamate synthase deficiency, carglumic acid was shown to induce a rapid normalisation of plasma ammonia levels, usually within 24 hours.
F’ pazjenti b’ nuqqas ta ’ N- acetylglutamate synthase, instab li carglumic acid jżid in- normalizzazzjoni ta ’ malajr tal- livelli ta ’ ammonja fil- plażma, ġeneralment fi żmien 24 siegħa.
When the treatment was instituted before any permanent brain damage, patients exhibited normal growth and psychomotor development.
Meta t- trattament inbeda qabel kull ħsara permanenti fil- moħħ, il- pazjenti wrew tkabbir normali u żvilupp psikomutur.
The pharmacokinetics of carglumic acid has been studied in healthy male volunteers using both radiolabelled and unlabelled product.
Il- farmakokinetiċi ta ’ carglumic acid ġew studjati f’ voluntieri rġiel b’ saħħithom bl- użu ta ’ prodotti radjutikkettati u mhux radjutikkettati.
Absorption After a single oral dose of 100 mg/ kg body weight, approximately 30% of carglumic acid is estimated to be absorbed.
Assorbiment Wara doża orali waħdanija ta ’ 100 mg/ kg piż korporali, madwar 30% ta ’ carglumic acid hi stmata li tista ’ tiġi assorbita.
At that dose-level, in 12 volunteers given Carbaglu tablets, plasma concentration peaked at 2.6 µg/ ml (median; range 1.8-4.8) after 3 hours (median; range 2-4).
F’ dik il- livell ta ’ doża, fi 12- il voluntiera mogħtija l- pilloli Carbaglu, il- konċentrazzjoni ta ’ plażma laħqet l- ogħla livell f’ 2. 6 µg/ ml (medjan; firxa 1. 8- 4. 8) wara tliet sigħat (medjan; firxa 2- 4).
Distribution The plasma elimination curve of carglumic acid is biphasic with a rapid phase over the first 12 hours after administration followed by a slow phase (terminal half life up to 28 hours).
Distribuzzjoni Il- kurva ta ’ l- eliminazzjoni minn ġol- plażma ta ’ carglumic acid hi bifażika b’ fażi rapida fl- ewwel 12- il siegħa wara l- amministrazzjoni segwita minn fażi kajmana (ħalf- life terminali sa 28 siegħa).
Diffusion into erythrocytes is non existent.
Id- diffużjoni fl- eritroċoti ma ssirx.
Protein binding has not been determined.
Ir- rabta mal- proteini għada ma ġietx stabbilita.
Metabolism A proportion of carglumic acid is metabolised.
Metabolżmu Proporzjon ta ’ carglumic acid jiġi metabolizzat.
It is suggested that depending on its activity, the intestinal bacterial flora may contribute to the initiation of the degradation process, thus leading to a variable extent of metabolism of the molecule.
Hu suġġerit li skond l- attività, il- flora batterika fl- imsaren tista ’ tikkontribwixxi għal bidu tal- proċess ta ’ degradazzjoni, li b’ hekk twassal għal metaboliżmu varjabbli tal- molekula.
One metabolite that has been identified in the faeces is glutamic acid.
Metabolit wieħed li ġie identifikat fl- ippurgar hu glutamic acid.
Metabolites are detectable in plasma with a peak at 36-48 hours and a very slow decline (half-life around 100 hours).
Il- metaboliti huma intraċċati fil- plażma f’ livelli massimi wara 36- 48 siegħa u tnaqqis kajman ħafna (ħalf- life ta ’ madwar 100 siegħa).
The end product of carglumic acid metabolism is carbon dioxide, which is eliminated through the lungs.
4 Il- prodott aħħari tal- metaboliżmu ta ’ carglumic acid hu d- dijossidu karboniku, li jiġi eliminate mill- pulmun.
Elimination After a single oral dose of 100 mg/ kg body weight, 9% of the dose is excreted unchanged in the urine and up to 60% in the faeces.
Eliminazzjoni Wara doża orali waħdanija ta ’ 100 mg/ kg piż korporali, 9% tad- doża tiġi eliminata mingħajr bidla fl- awrina u sa 60% fl- ippurgar.
Their range was consistent with
Il- livelli ta ’ carglumic acid fil- plażma kienu mkejjla f’ pazjenti fil- kategoriji ta ’ kull eta, minn trabi għadhom kif jitwieldu sa adoloxxenti, li ngħataw trattament b’ dożi ta ’ kuljum li jvarjaw (7 – 122 mg/ kg/ kuljum).
4 those measured in healthy adults, even in newborn infants.
Il- medda tagħhom kienet konsistenti ma ’ dik imkejla f’ adulti b’ saħħithom, anke fuq trabi għadhom kif jitwieldu.
Whatever the daily dose, they were slowly declining over 15 hours to levels around 100 ng/ ml.
Irrispettivament mid- doża ta ’ kuljum, kien hemm tnaqqis bil- mod f’ 15- il siegħa għal- livelli ta ’ madwar 100 ng/ ml.
Safety pharmacology studies have shown that Carbaglu administered orally at doses of 250, 500, 1000 mg/ kg had no statistically significant effect on respiration, central nervous system and cardiovascular system.
Studji dwar is- sigurtà farmakoloġika wrew li l- għotja ta ’ Carbaglu b’ mod orali b’ dożi ta ’ 250, 500, 1000 mg/ kg ma kellha l- ebda effett statistikament sinifikanti fuq respirazzjoni, fuq is- sistema nervuża ċentrali u fuq is- sistema kardjovaskulari.
Carbaglu showed no significant mutagenic activity in a battery of genotoxicity tests performed in vitro (Ames test, human lymphocyte metaphase analysis) and in vivo (micronucleus test in rat).
Carbaglu ma wera l- ebda attività mutaġenika sinifikanti f’ sensiela ta ’ testijiet dwar il- genotossiċità mwettqa in vitro (Ames Test, analiżi tal- metafażi tal- limfoċiti fil- bniedem) u in vivo (eżami mikronuklejari fil- far).
Single doses of carglumic acid up to 2800 mg/ kg orally and 239 mg/ kg intravenously did not induce any mortality or abnormal clinical signs in adult rats.
Dożi orali waħdanien ta ’ carglumic acid sa 2800 mg/ kg u 239 mg/ kg fil- vina ma wassal għall- ebda mortalità jew sinjali klinikament anormali fuq firien adulti.
In newborn rats receiving daily carglumic acid by oral gavage for 18 days as well as in young rats receiving daily carglumic acid for 26 weeks, the No Observed Effect Level (NOEL) was established at 500 mg/ kg/ day and the No Observed Adverse Effect Level (NOAEL) was established at 1000 mg/ kg/ day.
F’ firien li għadhom kif jitwieldu li rċevew carglumic acid kuljum fil- ħalq permezz ta ’ alimentazzjoni gastrika għal 18- il jum kif ukoll f’ firien żgħar li ngħataw carglumic acid kuljum għal 26 ġimgħa, kien stabbilit il- Livell ta ’ L- Ebda Effett Osservat (NOEL) b’ 500 mg/ kg/ kuljum u l- Livell ta ’ L- Ebda Effett Avvers Osservat (NOAEL) kien stabbilit b’ 1000 mg/ kg/ kuljum.
No adverse effects have been observed on male or female fertility.
L- ebda effetti avversi ma ġew osservati fuq il- fertilità ta ’ nisa u rġiel.
In rats and rabbits no evidence has been seen of embryotoxicity, foetotoxicity or teratogenicity up to maternotoxic doses leading to fifty times exposure as compared to humans in rats and seven times in rabbits.
Fil- firien u l- fniek ma kien ebda evidenza ta ’ embrijotossiċità, fetotossiċità jew teratoġeniċità sa dożi maternotossiċi li jwasslu għal espożizzjoni ta ’ ħamsin darba meta mqabbla bejn bnedmin u firien u seba ’ darbiet fil- fniek.
Carglumic acid is secreted in the milk of lactating rats and although developmental parameters were unaffected, there were some effects on body weight / body weight gain of pups breast-fed by dams treated with 500 mg/ kg/ day and a higher mortality of pups from dams treated with 2000/ kg/ day, a dose that caused maternotoxicity.
Carglumic acid jitnixxa fil- ħalib ta ’ firien li jreddhħu u għalkemm il- parametri ta ’ żvilupp ma kinux affettwati, kien hemm xi effetti fuq il- piż korporali / żieda fil- piż korporali ta ’ ġriewi mredgħa min- nisa trattati b’ 2000/ kg/ kuljum, doża li kkawżat maternotossiċità.
The maternal systemic exposures after 500 and 2000 mg/ kg/ day were twenty five times and seventy times the expected human exposure.
L- espożizzjonijiet sistematiċi materni wara 500 u 2000 mg/ kg/ kuljum kienu ħames darbiet u sebgħin darba l- espożizzjoni mistennija għal bniedem.
No carcinogenicity study has been conducted with carglumic acid.
L- ebda studju dwar il- karċinoġeniċità ma ġie mwettaq b’ carglumic acid.
Microcrystalline cellulose sodium laurilsulfate hypromellose croscarmellose sodium silica colloidal anhydrous sodium stearyl fumarate
Microcrystalline cellulose sodium laurilsulfate hypromellose croscarmellose sodium silica colloidal anhydrous sodium stearyl fumarate
6.3 Shelf life
5 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
1 month
30 xahar Wara li jinfetaħ ir- reċipjent tal- pilloli: xahar
5 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
Store in a refrigerator (2°C – 8°C)
Aħżen fi friġġ (2°C – 8°C)
After first opening of the tablet container:
Wara li tiftaħ għall- ewwel darba l- kontenitur tal- pilloli:
Do not refrigerate.
Tagħmlux fil- friġġ.
Do not store above 30°C.
Taħżinx f’ temperatura `l fuq minn 30°C.
Keep the container tightly closed in order to protect from moisture.
Żomm il- kontenitur magħluq sewwa sabiex tilqa ’ mill- umdità.
5-, 15- or 60- polypropylene tablet containers closed by a polyethylene cap with a desiccant unit.
Kontenitur ta ’ polypropylene li jesa ’ 5, 15 jew 60 pillola magħluq b’ għatu ta ’ polyethylene b’ desikkant ġo fih.
No special requirements
L- ebda ħtiġijiet speċjali
MARKETING AUTHORISATION HOLDER
SID TA ’ L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
Orphan Europe Immeuble “ Le Wilson” F-92058 Paris La Défense France
Orphan Europe Immeuble “ Le Wilson ” F- 92058 Paris La Défense Franza
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
EU/ 1/ 02/ 246/ 001 (15 dispersible tablets) EU/ 1/ 02/ 246/ 002 (60 dispersible tablets) EU/ 1/ 02/ 246/ 003 (5 dispersible tablets)
EU/ 1/ 02/ 246/ 001 (15- il pillola li jinfirxu) EU/ 1/ 02/ 246/ 002 (60- il pillola li jinfirxu) EU/ 1/ 02/ 246/ 003 (5 pilloli li jinfirxu)
24 January 2003
24 ta ’ Jannar 2003
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA) http: // www. emea. europa. eu
6 ANNEX II
6 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
SID L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦALL - KUMMERĊ
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
7 A SID L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- manufattur responsabbli mill- ħruġ tal- lott
Orphan Europe, Immeuble ‘ Le Wilson’, 70 avenue du Général de Gaulle, F-92800 Puteaux, France
Orphan Europe, Immeuble ‘ Le Wilson ’, 70 Avenue du Général de Gaulle, F- 92800 Puteaux, Franza
CONDITIONS OF THE MARKETING AUTHORISATION
B KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ SID L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
Summary of Product Characteristics, section 4.2)
Karatteristiċi tal- Prodott fil - Qosor, sezzjoni 4. 2)
Not applicable.
Ma jgħoddx f’ dan il- każ
8 ANNEX III
8 ANNESS III
10 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
10 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON BOX AND TABLET CONTAINER LABEL X 5 TABLETS
KAXXA TAL- KARTUN TA ’ BARRA U TIKKETTA TAL- KONTENITUR TAL- PILLOLI X 5 PILLOLI
Carbaglu 200 mg dispersible tablets Carglumic acid
Carbaglu 200 mg pilloli li jinfirxu Carglumic acid
5 dispersible tablets
5 pilloli li jinfirxu
Oral use Read the package leaflet before use
Jittieħed mill- ħalq Aqra l- fuljett ta ’ tagħrif qabel l- użu
EXP {MM/ YYYY} Discard one month after first opening.
JIS {XX/ SSSS} Armi xahar wara li jinfetaħ għall- ewwel darba.
Opened:
Infetaħ:
After first opening of the tablet container: do not refrigerate, do not store above 30°C.
Wara li tiftaħ għall- ewwel darba l- kontenitur tal- pilloli: tagħmlux fil- friġġ, taħżinx f’ temperatura `l fuq minn 30°C.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TA ’ SID L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
MANUFACTURER’ S BATCH NUMBER
NUMRU TAL- LOTT TAL - MANIFATTUR
Batch {number}
Lott {numru}
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
12 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON BOX AND TABLET CONTAINER LABEL X 15 TABLETS
KAXXA TAL- KARTUN TA ’ BARRA U TIKKETTA TAL- KONTENITUR TAL- PILLOLI X 15- IL PILLOLA
15 dispersible tablets
15- il pillola li jinfirxu
Keep out of the reach and sight of children.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal
Opened:
Aqra l- fuljett ta ’ tagħrif qabel tużah
Store in a refrigerator (2°C – 8°C)
DATA TA ’ META JISKADI
After first opening of the tablet container: do not refrigerate, do not store above 30°C.
Infetaħ:
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
KUNDIZZJONIJIET SPEĊJALI TA 'KIF JINĦAŻEN
Batch {number}
< Lott > [numru]
60 dispersible tablets
60 pillola li jinfirxu
Oral use Read the package leaflet before use.
Jittieħed mill- ħalq Aqra l- fuljett ta ’ tagħrif qabel l- użu
17 PACKAGE LEAFLET: INFORMATION FOR THE USER
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU
Carbaglu 200 mg dispesible tablets Carglumic acid
Carbaglu 200 mg pilloli li jinxterdu Carglumic acid
Read all of this leaflet carefully before you start taking this medicine.
Aqra sew dan il- fuljett kollu qabel tibda tieħu din il- mediċina
You may need to read it again.
Jista jkollok bżonn terġa taqrah.
- If you have further questions, please ask your doctor or your pharmacist.
- Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek.
It
- Din il- mediċina ġiet mogħtija għall- użu personali tiegħek u m’ għandekx tagħtiha lil persuni
may harm them, even if their symptoms are the same as yours.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollom l- istess sintomi bħal tiegħek.
What Carbaglu is and what it is used for 2.
X’ inhu Carbaglu u għalxiex jintuża 2.
Before you take Carbaglu 3.
Qabel ma tieħu Carbaglu 3.
How to take Carbaglu 4.
Kif għandek tieħu Carbaglu 4.
Possible side effects 5 How to store Carbaglu 6.
Kif taħżen Carbaglu 6.
WHAT CARBAGLU IS AND WHAT IT IS USED FOR
X’ INHU CARBAGLU U GĦALXIEX JINTUŻA
Carbaglu can help eliminating excess of hyperammonaemia (elevated ammonia level in the blood), due to the lack of a specific liver enzyme N- acetylglutamate synthase.
Carbaglu jista ’ jgħin jelimina iperammonemija (livell għoli ta ’ ammonja fid- demm), kkawżata minn nuqqas ta ’ enżima speċifika tal- fwied, N- acetylglutamate synthase.
Patients with this rare disorder are not able to eliminate nitrogen waste, which builds up after eating protein.
Pazjenti b’ din il- marda rari ma jkunux jistgħu jeliminaw in- nitroġenu mill- ġisem, li jinġabar wara li jittieklu l- proteini.
Nitrogen waste is in the form of ammonia, which is especially toxic for the brain and leads, in severe cases, to reduced levels of consciousness and to coma.
In- nitroġenu u fil- forma ta ’ ammonja, li hi partikolarment tossika għall- moħħ, u f’ każi serji twassal għal tnaqqis tal - koxjenza u għal koma.
This disorder will persist during the entire life time of the patient and therefore the need for this treatment is lifelong.
Din il- marda tippersiti matul il- ħajja kollha tal- pazjent u għalhekk il- bżonn għal dan it- trattament jibqa ’ tul il- ħajja kollha.
BEFORE YOU TAKE CARBAGLU
QABEL MA TIEĦU CARBAGLU
Do not take Carbaglu:
Tieħux Carbaglu:
Do not take Carbaglu if you are hypersensitive (allergic) to carglumic acid or any of the other ingredients of Carbaglu.
Tieħux Carbaglu jekk tbati minn sensittività eċċessiva (allerġija) għal carglumic aċid jew sustanzi oħra ta ’ Carbaglu.
Do not take Carbaglu during breast-feeding
Tieħux Carbaglu jekk qed tredda ’.
Take special care with Carbaglu:
Oqgħod attent ħafna b’ Carbaglu:
Your doctor will test your individual responsiveness to carglumic acid before initiating any long term treatment.
It- tabib tiegħek se jeżaminalek ir- rispons individwali għal carglumic acid qabel jingħata bidu għal xi trattament fuq medda twila ta ’ żmien.
The dose should be adjusted individually in order to maintain normal ammonia plasma levels.
Id- doża għandha tkun mibdula skond l- indivdwu biex jinżammu l- livelli normali ta ’ ammonja fil - plażma.
Your doctor may prescribe supplemental arginine or restrict your protein intake.
It- tabib tiegħek jista ’ jgħidlek biex tieħu ammont żejjed ta ’ arginine jew biex tnaqqas l- ammont ta ’ proteini li tieħu.
In order to follow-up your condition and your treatment, your doctor may examine your liver, your kidneys, your heart and your blood on a regular basis.
Sabiex ikun jista ’ jsegwi l- kondizzjoni u t- trattament tiegħek, it- tabib għandu mnejn jeżaminalek il - fwied, il- kliewi, il- qalb u d- demm tiegħek fuq bażi regolari.
18 Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki mhux bir- riċetta.
Taking Carbaglu with food and drink Carbaglu must be taken orally before meals or feedings.
Meta tieħu Carbaglu ma ’ l- ikel u x- xorb Carbaglu għandu jittieħed mill- ħalq qabel l- ikel jew tmigħ.
The tablets must be dispersed in a minimum of 5 to 10 ml of water and taken immediately.
Il- pilloli għandhom jinfirxu f’ minimu ta ’ 5 sa 10 ml ilma u għandhom jittieħdu minnufih.
The suspension has a slightly acidic taste.
Is - suspensjoni għandha togħma kemmxejn aċiduża.
Pregnancy and Breast-feeding
Tqala u Treddigħ
The effects of Carbaglu on pregnancy and the unborn child are not known.
L- effetti ta ’ Carbaglu fuq it- tqala u fuq it- tarbija mhix mwielda mhumiex magħrufa.
Please consult your doctor for advice if you are pregnant or planning to become pregnant.
Jekk jogħġbok ikkonsulta t- tabib tiegħek għal parir jekk inti tqila jew qed taħseb biex tinqabad tqila.
The excretion of carglumic acid into breast milk has not been studied in women.
L- eliminazzjoni ta ’ carglumic acid fil- ħalib ta ’ l- omm għadu ma ġiex studjat fin- nisa.
Nevertheless, as carglumic acid has been shown to be present in the milk of lactating rats with potential toxic effects for their fed pups, you should not breast feed your baby if you are taking Carbaglu.
Madankollu, peress li carglumic acid ġie muri li hu preżenti fil- ħalib ta ’ ommijiet firien b’ effetti potenzjali tossiċi għal ġriewi mredda ’ tagħhom, inti m’ għandekx tredda ’ it- tarbija tiegħek jekk qed tieħu Carbaglu.
Driving and using machines Effects on the ability to drive and use machines are not known.
L- effetti fuq il- ħila għas- sewqan u biex tħaddem il- magni m’ humiex magħrufa.
HOW TO TAKE CARBAGLU
KIF JITTIEĦED CARBAGLU
Always take Carbaglu exactly as your doctor has instructed you.
Dejjem għandek tieħu Carbaglu skond il- parir tat- tabib tiegħek.
You should check with your doctor or pharmacist if you are unsure.
Dejjem għandek taċċerta ruħek mat- tabib jew spiżjar tiegħek jekk ikollok xi dubju.
The usual dose:
Id- doża normali:
- the initial daily dose is usually 100 mg per kilogram of body weight, up to a maximum of
- id- doża inizjali ta ’ kuljum hi ġeneralment ta ’ 100 mg kull kilogramma ta ’ piż tal- ġisem, sa
250 mg per kilogram of body weight (for example, if you weight 10kg, you should take 1g per day, or 5 tablets),
massimu ta ’ 250 mg kull kilogramma ta ’ piż tal- ġisem (pereżempju jekk inti tiżen 10 kg, għandek tieħu 1g kuljum jew 5 pilloli),,
- in the long term, the daily dose usually ranges from 10 mg to 100 mg per kilogram of body
- fuq medda twila ta ’ żmien, id- doża ta ’ kuljum tvarja minn 10 mg sa 100 mg kull kilogramma ta ’
weight.
piż tal- ġisem.
Your doctor will determine the dose suitable to you in order to maintain normal ammonia levels in your blood.
It- tabib tiegħek jiddeċiedi d- doża meħtieġa minnek biex iżommlok il- livelli normali ta ’ ammonja fid - demm tiegħek.
When the patient is in hyperammonaemic coma, Carbaglu is administered by fast push through a syringe via the tube set up and used to feed you..
Meta l- pazjent jinsab f’ koma iperammonemika, Carbaglu jingħata b’ għafsa ta ’ malajr permezz ta ’ siringa minn tubu li jitqiegħed biex ikun jista ’ jisqik.
If you take more Carbaglu than you should:
Jekk tieħu Carbaglu aktar milli suppost għandek:
Ask your doctor or pharmacist for advice.
Staqsi għal parir lit- tabib jew spiżjar tiegħek.
If you forget to take Carbaglu:
Jekk tinsa tieħu Carbaglu:
Do not take a double dose to make up for forgotten individual doses.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
POSSIBLE SIDE EFFECTS
X’ EFFETTI OĦRA JISTA ’ JKOLLU
Like all medicines, Carbaglu can have side effects.
Bħall- kull mediċina oħra, Carbaglu jista ’ jkollu effetti oħra.
The following side effects were reported as follows: very common (occurring in at least one in 10 patients), common (occurring in at least one in 100 patients), uncommon (occurring in at least one
L- effetti kollaterali li ġejjin ġew rapportati kif ġej: komuni ħafna (li jseħħ f’ ta ’ lanqas pazjent wieħed f’ kull 10), komuni (li jseħħ f’ ta ’ lanqas pazjent 1 f’ kull 100), mhux komuni (li jseħħ f’ ta ’ lanqas pazjent wieħed f’ kull 1, 000) rari (li jseħħ f’ ta ’ lanqas pazjent wieħed f’ kull 10, 000), rari ħafna (li jseħħ f’ ta ’ lanqas wieħed f’ kull 100, 000).
19 in1,000 patients), rare (occurring in at least one in 10,000 patients), very rare (occurring in at least one in 100,000 patients). • Common: increased sweating • Uncommon: increased transaminases
19 • Komuni: żieda fit- tagħriq • Mhux komuni: transaminases ogħla
If you notice any side effects, please inform your doctor or pharmacist.
Jekk tinduna b ’ xi effetti oħrajn, jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE CARBAGLU
KIF TAĦŻEN CARBAGLU
Do not use after the expiry date stated on the tablet container.
M’ għandekx tuża wara d- data li jiskadi li tidher fuq il- kontenitur tal- pilloli.
After first opening of the container: do not refrigerate, do not store above 30°C.
Wara li tiftaħ għall- ewwel darba l- kontenitur tal- pilloli, tagħmlux fil- friġġ, taħżinx f’ temperatura `l fuq minn 30°C.
Write the date of opening on the tablet container.
Ikteb id- data ta ’ meta ftaħtu fuq il- kontenitur tal- pilloli.
Discard 1 month after first opening.
Armih xahar wara li tkun ftaħtu għall- ewwel darba.
FURTHER INFORMATION
GĦAL AKTAR TAGĦRIF
Carbaglu 200 mg dispersible tablets Carglumic acid
Carbaglu 200 mg pilloli li jinferxu Cabglumic acid
- The active substance is carglumic acid.
- Is- sustanza attiva hi carglumic acid.
- The other ingredients are microcrystalline cellulose, sodium laurilsulfate, hypromellose,
- Sustanzi oħra jinkludu microcrystalline cellulose, sodium laurilsulfate, hypromellose,
croscarmellose sodium, silica colloidal anhydrous, sodium stearyl fumarate.
croscarmellose sodium, silica colloidal anhydrous, sodium stearyl fumarate.
Marketing Authorisation Holder and Manufacturer Orphan Europe Immeuble “ Le Wilson” F-92058 Paris La Défense France Tel: + 33 1 4773 6458 Fax: + 33 1 4900 1800
Sid l- Awtorizzazzjoni għall- Kummerċ u Manifattur Orphan Europe Immeuble “ Le Wilson ” F- 92058 Paris La Défense Franza Tel: + 33 1 4773 6458 Faks: + 33 1 4900 1800
20 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
20 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tas- Sid ta ’ l- Awtorizzazzjoni għall- Kummerċ
This leaflet was last approved on
Dan il- fuljett kien approvat l- aħħar fl -
This document is a summary of the European Public Assessment Report (EPAR).
Dan id- dokument huwa sommarju tar- Rapport tal- Valutazzjoni Pubblika Ewropea (EPAR).
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk teħtieġ iktar tagħrif dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (li hu wkoll parti mill- EPAR) jew kellem lit- tabib jew lill- ispiżjar tiegħek Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is CellCept?
X’ inhu CellCept?
CellCept is a medicine containing the active substance mycophenolate mofetil.
CellCept huwa mediċina li fiha s- sustanza attiva mikofenolat mofetil (mycophenolate mofetil).
It is available as capsules (250 mg), tablets (500 mg), a powder to be made up into an oral suspension (1 g/ 5 ml) and a powder to be made up into a solution for infusion (drip into a vein; 500 mg).
Jiġi bħala kapsuli (250 mg), pilloli (500 mg), trab li jinħall f’ sospensjoni orali (1 g/ 5 ml) u trab li jinħall f’ soluzzjoni għall- infużjoni (dripp fil- vina; 500 mg).
What is CellCept used for?
Għal xiex jintuża CellCept?
CellCept is used to prevent the body from rejecting a transplanted kidney, heart or liver.
CellCept jintuża biex ma jħallix lill- ġisem jiċħad kilwa, qalb jew fwied trapjantati.
It is used with ciclosporin and corticosteroids (other medicines used to prevent organ rejection).
Jintuża flimkien ma ’ ċiklosporina (ciclosporin) u kortikosterojdi (mediċini oħra użati fil- prevenzjoni tat- tiċħid ta ’ l - organi).
How is CellCept used?
Kif jintuża CellCept?
CellCept treatment should be initiated and maintained by a qualified transplant specialist.
It- trattament b’ CellCept għandu jinbeda u jitkompla minn speċjalista tat- trapjanti kwalifikat.
The way that CellCept should be given and the dose depend on the type of organ transplant and the patient ’ s age and size.
Il- mod li bih jingħata CellCept kif ukoll id- doża jiddependu mit- tip ta ’ trapjant ta ’ l- organu u mill- età u d- daqs tal- pazjent.
For kidney transplants, the recommended dose in adults is 1.0 g twice a day by mouth (capsules, tablets or oral suspension) starting within 72 hours after the transplant.
Għat- trapjanti tal- kliewi, id- doża rakkomandata fl- adulti hija 1. 0 g darbtejn kuljum oralment (kapsuli, pilloli jew sospensjoni orali) u jibda minn 72 siegħa wara t- trapjant.
It can also be given as an infusion lasting two hours starting within 24 hours after the transplant, for up to 14 days.
Jista ’ jingħata wkoll bħala infużjoni ta ’ sagħtejn li tista ’ tibda minn 24 siegħa sa 14- il jum wara li jkun sar it- trapjant.
In children aged between two and 18 years, the dose of CellCept is calculated depending on height and weight and should be given by mouth.
Fit- tfal ta ’ bejn sentejn u 18- il sena, id- doża ta ’ CellCept tiġi kkalkulata skond it- tul u l- piż u għandha tingħata oralment.
For heart transplants, the recommended adult dose is 1.5 g twice a day by mouth, starting within five days following the transplant.
Għat- trapjanti tal- qalb, id- doża rakkomandata għall- adulti hija 1. 5 g oralment darbtejn kuljum, li għandha tibda minn ħamest ijiem wara t- trapjant.
For liver transplants in adults, CellCept should be given as a 1-g infusion twice a day for the first four days after the transplant, before the patient is switched to 1.5 g twice a day by mouth as soon as it can be tolerated.
Għat- trapjanti tal- fwied fl- adulti, CellCept għandu jingħata bħala infużjoni ta ’ 1g darbtejn kuljum għall- ewwel erbat ijiem wara t- trapjant, qabel ma l- pazjent jaqleb għal doża ta ’ 1. 5 g oralment darbtejn kuljum hekk kif jibda jiġi tollerat.
CellCept is not recommended for use in children after heart or liver transplants because of a lack of information on its effects in this group.
CellCept mhuwiex rakkomandat għall- użu fit- tfal wara t- trapjanti tal- qalb jew 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 b’ mard tal- fwied jew tal- qalb.
For more information, see the Summary of Product Characteristics (also part of the EPAR).
Għal iktar tagħrif, ara s - Sommarju tal- Karatteristiċi tal- Prodott (ukoll parti mill- EPAR).
How does CellCept work?
Kif jaħdem CellCept?
The active substance in CellCept, mycophenolate mofetil, is an immunosuppressive medicine.
Is- sustanza attiva f’ CellCept, mikofenolat mofetil hija mediċina immunosuppressiva.
In the body, it is converted into mycophenolic acid, which blocks an enzyme called ‘ inosine monophosphate dehydrogenase’.
Fil- ġisem, tinbidel f’ aċidu mikofenoliku (mycophenolic acid), li jimblokka enżim magħruf bħala inosina - monofosfat- deidrogenasi (‘ inosine monophosphate dehydrogenase ’).
This enzyme is important for the formation of DNA in cells, particularly in the 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Dan l- enzim huwa importanti fil - 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. lymphocytes (a type of white blood cell which is involved in the rejection of organ transplants).
Reproduction is authorised provided the source is acknowledged. formazzjoni tad- DNA fiċ- ċelloli, partikolarment fil- limfoċiti (tip ta ’ ċelloli tad- demm bojod) li għandhom x’ jaqsmu mat- tiċħid ta ’ trapjanti ta ’ l- organi).
By preventing the production of new DNA, CellCept reduces the rate at which the lymphocytes multiply.
Bil- prevenzjoni tal- produzzjoni ta ’ DNA ġdid, CellCept inaqqas ir- rata tat- tkattir tal- limfoċiti.
This makes them less effective at recognising and attacking the transplanted organ, lowering the risk of the organ being rejected.
Dan jagħmilhom inqas effettivi fl- għarfien u fl - attakki fuq l- organi trapjantati, u b’ hekk inaqqas ir- riskju li l- organu jiġi riġettat.
How has CellCept been studied?
Kif ġie studjat CellCept?
CellCept capsules and tablets have been studied in three studies involving a total of 1,493 adults following kidney transplant, in one study involving 650 adults following heart transplant and in one study involving 565 adults following liver transplant.
Il- kapsuli u l- pilloli ta ’ CellCept ġew studjati fi tliet studji li fihom ħadu sehem 1, 493 adult wara trapjant tal- kliewi, fi studju wieħed ħadu sehem 650 adult wara trapjant tal- qalb u fi studju ieħor ħadu sehem 565 adult wara trapjant tal- fwied.
CellCept was compared with azathioprine (another anti-rejection medicine) in all studies except for one of the kidney transplant studies, in which it was compared with placebo (a dummy treatment).
CellCept tqabbel ma ’ ażatioprina (azathioprine - mediċina oħra kontra t- tiċħid ta ’ organi barranin) fl- istudji kollha ħlief f’ wieħed mill- istudji tat- trattament tal - kliewi, li fih tqabbel ma ’ plaċebo (trattament finta).
A further study looked at the effect of CellCept oral suspension in 100 children following a kidney transplant.
Studju ieħor ħares lejn l- effett tas- soluzzjoni orali ta ’ CellCept f’ mitt tifel u tifla wara trapjant tal- kliewi.
In all of the studies, all of the patients also received ciclosporin and corticosteroids, and the main measure of effectiveness was the proportion of patients whose new organ had been rejected after six months.
Fl- istudji kollha, il- pazjenti kollha ngħataw ukoll sospensjoni orali ta ’ ċiklosporina u korticosterojdi, u l- mezz ewlieni tal- kejl ta ’ l- effikaċja kien il- proporzjon ta ’ pazjenti li ċaħdu l- organu l- ġdid tagħhom wara sitt xhur.
Further studies showed that the solution for infusion and the oral suspension produced similar levels of the active substance in the blood as the capsules.
Studji oħra wrew li s- soluzzjoni għall- infużjoni u s- sospensjoni orali wasslu għal livelli simili tas - sustanza attiva fid- demm daqs dik fil- kapsuli.
What benefit has CellCept shown during the studies?
X’ inhuma l- benefiċċji ta ’ CellCept li ntwerew f’ dawn l- istudji?
CellCept was as effective as azathioprine and more effective than placebo in preventing the rejection of transplanted kidneys after six months.
CellCept kien effettiv daqs ażatioprina u iktar effettiv mill- plaċebo fil- prevenzjoni tat- tiċħid tal- kliewi trapjantati wara sitt xhur.
In children undergoing kidney transplants, the rejection rates were similar to those seen in adults taking CellCept and lower than those seen in other studies of children who did not receive CellCept.
Fit- tfal li kien se jsirilhom trapjant tal- kliewi, ir- rati ta ’ tiċħid kienu simili għal dawk li dehru f’ adulti li kienu qed jieħdu CellCept u inqas minn dawk li dehru fi studji oħra ta ’ tfal li ma ngħatawx CellCept.
In the heart transplant study, around 38% of patients taking CellCept and those taking azathioprine experienced rejection after six months.
Fl- istudju tat- trapjanti tal- qalb, madwar 38% tal- pazjenti li ngħataw CellCept u dawk li kienu qed jieħdu ażatioprina kellhom tiċħid ta ’ l- organu wara sitt xhur.
Following liver transplant, 38% of the patients taking CellCept had rejected their new liver after six months, compared with 48% of those taking azathioprine, but the proportion of patients who had lost their new liver after a year was similar in the two groups, at around 4%.
Wara t- trapjant tal- fwied, 38% tal - pazjenti li kienu qed jieħdu CellCept kienu ċaħdu l- fwied il- ġdid wara sitt xhur, meta mqabbla ma ’ 48% ta ’ dawk li kienu qed jieħdu ażatioprina, iżda l- proporzjon ta ’ pazjenti li kienu tilfu l- fwied il - ġdid wara sena kien simili fiż- żewġ gruppi, madwar 4%.
What is the risk associated with CellCept?
X’ inhu r- riskju assoċjat ma ’ CellCept?
The most serious risk associated with CellCept is the possible development of cancer, particularly lymphoma and skin cancer.
L- iktar riskju serju assoċjat ma ’ CellCept huwa l- possibilità ta ’ l- iżvilupp tal- kankru, partikolarment dak fil- limfoma u fil- ġilda.
The most common side effects with CellCept used in combination with ciclosporin and corticosteroids (seen in more than 1 patient in 10) are sepsis (blood infection), gastrointestinal candidiasis (a fungal infection of the stomach or gut), urinary tract infection (infection of the structures that carry urine), herpes simplex (a viral infection that causes cold sores), herpes zoster (a viral infection that causes chickenpox and shingles), leucopenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), vomiting, abdominal (tummy) pain, diarrhoea and nausea (feeling sick).
L- iktar effett sekondarju komuni ma ’ CellCept użat f’ kombinazzjoni ma ’ ċiklosporina u korticosterojdi (li dehru f’ iktar minn pazjent wieħed minn kull 10) huma s- sepsis (infezzjoni fid- demm), kandidjasi gastrointestinali (infezzjoni fungali ta ’ l- istonku jew tal- musrana), infezzjoni fil- pajp li minnu tgħaddi l- awrina, herpes simplex (infezzjoni virali li tikkawża selħiet fix - xufftejn), herpes zoster (infezzjoni virali li tikkawża l- ġidri riħ u l- ħruq ta ’ Sant’ Antnin), il- lewkopenja (tnaqqis fl- għadd ta ’ ċelloli tad- demm bojod), tromboċitopenija (tnaqqis fil- livelli tal- pjastrini fid - demm), rimettar, uġigħ ta ’ żaqq, dijarrea u dardir.
For the full list of side effects reported with CellCept, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji rrappurtati ma ’ CellCept, ara l- Fuljett ta ’ Tagħrif.
CellCept should not be used in people who may be hypersensitive (allergic) to mycophenolate mofetil or mycophenolic acid.
CellCept m’ għandux jintuża f’ persuni li jistgħu jkunu allerġiċi għal mikofenolat mofetil jew għall - aċidu mikofenoliku.
It should not be used in women are breast-feeding.
M’ għandux jintuża f’ nisa li jkunu qed ireddgħu.
CellCept treatment is not recommended for use in pregnant women, and should only be started in women after a negative pregnancy test and if effective contraception is used before, during and for six weeks after CellCept treatment.
It- trattament b’ CellCept mhux rakkomandat li jintuża f’ nisa tqal, u għandu jinbeda biss f’ nisa b’ test tat- tqala negattiv u jekk tintuża kontraċezzjoni effettiva qabel, waqt u għal sitt ġimgħat wara t- trattament b’ CellCept.
Why has CellCept been approved?
Għaliex ġie approvat CellCept?
The Committee for Medicinal Products for Human Use (CHMP) decided that CellCept’ s benefits are greater than its risks in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ CellCept huma ikbar mir- riskji tiegħu meta użat flimkien ma ’ ċiklosplorina u korticosterojdi għall - prevenzjoni ta ’ tiċħid akut ta ’ wara t- trapjant f’ pazjenti li kienu ngħataw trapjanti alloġeneiċi tal - kliewi, tal- qalb jew tal- fwied.
The Committee recommended that CellCept be given marketing authorisation.
Il- Kumitat irrakkomanda li CellCept jingħata l- awtorizzazzjoni għat - tqegħid fis- suq.
Other information about CellCept:
Tagħrif ieħor dwar CellCept:
The European Commission granted a marketing authorisation valid throughout the European Union for CellCept to Roche Registration Limited on 14 February 1996.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal CellCept lil Roche Registration Limited fl- 14 ta ’ Frar 1996.
The marketing authorisation was renewed on 14 February 2001 and on 14 February 2006.
L- awtorizzazzjoni għat- tqegħid fis - suq ġiet imġedda fl- 14 ta ’ Frar 2001 u fl- 14 ta ’ Frar 2006.
The full EPAR for CellCept can be found here.
L- EPAR sħiħ għal CellCept jista ’ jinstab minn hawnhekk.
CellCept 250 mg capsules.
CellCept 250 mg kapsuli.
Each capsule contains 250 mg mycophenolate mofetil.
Kull kapsula fiha 250 mg mycophenolate mofetil.
Capsules, hard.
Kapsuli, iebsin.
CellCept capsules: oblong, blue/ brown, branded with black "CellCept 250" on the capsule cap and "Company logo" on the capsule body.
Kapsuli CellCept: oblung, blu/ kannella, ttimbrati bl- iswed b ’ "CellCept 250" fuq - l- għatu tal- kapsula u bil - “ logo tal- Kumpanija ” fuq il- parti l- oħra.
CellCept is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
CellCept huwa ndikat f’ taħlita ma 'ciclosporin u kortikosterojdi għall- profilassi ta ’ tiċħid akut tat- trapjant f' pazjenti li rċevew trapjant alloġeniku renali, tal- qalb, jew tal- fwied.
Treatment with CellCept should be initiated and maintained by appropriately qualified transplant specialists.
Il- kura b' CellCept għandha tinbeda u titkompla, minn speċjalisti tat- trapjanti bi kwalifikazzjoni xierqa.
Use in renal transplant:
Użu fi trapjanti tal- kliewi:
Adults: oral CellCept should be initiated within 72 hours following transplantation.
CellCept mill- ħalq għandu jinbeda 72 siegħa wara li jkun sar it- trapjant.
The recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose).
Id- doża rakkomandata f' pazjenti bi trapjant tal- kliewi hija ta '1 g mogħtija darbtejn kuljum (doża ta ’ 2 g kuljum).
Children and adolescents (aged 2 to 18 years): the recommended dose of mycophenolate mofetil is 600 mg/ m2 administered orally twice daily (up to a maximum of 2 g daily).
Tfal u adoloxxenti (b’ età minn 2 sa 18- il sena): id- doża rakkomandata ta 'mycophenolate mofetil hija ta' 600 mg/ m2 mogħtija mill- ħalq darbtejn kuljum (sa massimu ta ’ 2 g kuljum).
CellCept capsules should only be prescribed to patients with a body surface area of at least 1.25 m2.
Il- kapsuli CellCept għandhom jiġu preskritti biss lill- pazjenti li ġisimhom huwa ta ’ erja ta ’ mill- inqas 1. 25 m2.
Patients with a body surface area of 1.25 to 1.5 m2 may be prescribed CellCept capsules at a dose of 750 mg twice daily (1.5 g daily dose).
Pazjenti li ġisimhom huwa ta ’ erja ta ’ bejn 1. 25 u 1. 5 m2 jistgħu jiġu preskritti kapsuli CellCept 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 CellCept capsules at a dose of 1 g twice daily (2 g daily dose).
Pazjenti li ġisimhom huwa ta ’ erja ta ’ aktar minn 1. 5 m2 jistgħu jiġu preskritti kapsuli CellCept 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 jseħħu b’ iktar frekwenza f’ pazjenti ta 'din l- età (ara sezzjoni 4. 8) meta mqabbla ma ’ adulti, jista ’ jkun hemm bżonn li jew titwaqqaf il- mediċina għal ftit żmien jew titnaqqas id- doża; dawn ikollhom bżonn jieħdu f’ kunsiderazzjoni fatturi kliniċi relevanti inkluż s- severità tar- reazzjoni.
Children (< 2 years): there are limited safety and efficacy data in children below the age of 2 years.
Tfal (< sentejn (2)): hemm tagħrif ta ’ sigurtà u effikaċja limitat fi tfal taħt l- età ta ’ sentejn.
These are insufficient to make dosage recommendations and therefore use in this age group is not recommended.
Dawn m’ humiex suffiċjenti biex isiru rakkomandazzjonijiet tad- doża u għalhekk użu f’ dan il- grupp ta ’ età m’ huwiex rakkomandat.
Use in cardiac transplant:
Użu ta 'CellCept f' pazjenti bi trapjant tal- qalb:
Adults: oral CellCept should be initiated within 5 days following transplantation.
CellCept mill- ħalq għandu jinbeda sa 5 ijiem wara li jkun sar it- 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 tal- qalb hija ta '1. 5 g mogħtija darbtejn kuljum (doża ta ’ 3 g kuljum).
Children: no data are available for paediatric cardiac transplant patients.
Tfal: m’ hemmx tagħrif disponnibli dwar pazjenti pedjatriċi bi trapjant tal- qalb.
2 Use in hepatic transplant:
2 Użu fi trapjanti tal- fwied:
IV CellCept should be administered for the first 4 days following hepatic transplant, with oral CellCept initiated as soon after this as it can be tolerated.
CellCept IV għandu jiġi mogħti għall- ewwel erbat ijiem wara t- trapjant tal- fwied, u wara CellCept mill- ħalq għandu jinbeda malajr kemm jista ’ jkun, hekk kif jiġi ttollerat.
The recommended oral dose in hepatic transplant patients is 1.5 g administered twice daily (3 g daily dose).
Id- doża rakkomandata f' pazjent bi trapjant tal- fwied hija ta '1. 5 g mogħtija darbtejn kuljum (doża ta ’ 3 g kuljum).
Children: no data are available for paediatric hepatic transplant patients.
Tfal: m’ hemmx tagħrif disponnibli dwar pazjenti pedjatriċi bi trapjant tal- fwied.
Use in elderly (≥ 65 years): the recommended dose of 1 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.
Użu fl- anzjani (≥ 65 sena): id- doża rakkomandata hija ta '1 g mogħtija darbtejn kuljum għall- pazjenti bi trapjant renali u 1. 5 g darbtejn kuljum għall- pazjenti bi trapjanti tal- qalb jew tal- fwied hija xieraq għall - anzjani.
Use in renal impairment: 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.
Użu f' pazjenti b’ indeboliment renali: f’ pazjenti bi trapjant tal- kliewi b’ indeboliment kroniku, sever renali (rata ta 'filtrazzjoni tal- glomerulus < 25 ml• min- 1• 1. 73 m- 2), wara l- perijodu immedjat ta ’ wara t- trapjant, dożi aktar minn 1 g mogħtija darbtejn kuljum għandhom jiġu evitati.
These patients should also be carefully observed.
Dawn il- pazjenti għandhom ukoll jiġu ssorveljati b’ reqqa.
No dose adjustments are needed in patients experiencing delayed renal graft function post-operatively (see section 5.2).
M' hemmx bżonn ta ’ aġġustament fid- doża f' pazjenti, li l- kliewi tagħhom idumu biex jibdew jaħdmu wara l- operazzjoni (ara sezzjoni 5. 2).
No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment.
M’ hemmx tagħrif disponibbli dwar pazjenti bi trapjant tal- qalb jew epatiku b’ indeboliment kroniku sever tal- kliewi.
Use in severe hepatic impairment: no dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease.
Użu f' pazjenti b’ indeboliment tal- fwied: m' hemmx bżonn ta ’ aġġustament fid- doża f' pazjenti bi trapjant renali b’ mard parenkimali sever tal- fwied.
No data are available for cardiac transplant patients with severe hepatic parenchymal disease.
M’ hemmx tagħrif dwar pazjenti bi trapjant tal- qalb b’ mard parenkimali sever tal- fwied.
Treatment during rejection episodes:
Kura waqt episodji ta ’ tiċħid:
MPA (mycophenolic acid) is the active metabolite of mycophenolate mofetil.
MPA (mycophenolic acid) huwa l- metabolit attiv ta ’ mycophenolate mofetil.
Renal transplant rejection does not lead to changes in MPA pharmacokinetics; dosage reduction or interruption of CellCept is not required.
Tiċħid ta ’ trapjant renali ma jwassalx għall- bidla fil- farmakokinetika ta 'MPA; tnaqqis fid- dożaġġ jew waqfien ta ’ CellCept mhux meħtieġ.
There is no basis for CellCept dose adjustment following cardiac transplant rejection.
M’ hemmx bażi għal aġġustament tad- doża ta ’ CellCept wara tiċħid ta ’ trapjant tal- qalb.
No pharmacokinetic data are available during hepatic transplant rejection.
Tagħrif farmakokinetiku waqt tiċħid ta ’ trapjant epatiku mhux disponibbli.
Hypersensitivity reactions to CellCept have been observed (see section 4.8).
Kienu osservati reazzjonijiet ta 'sensittività eċċessiva għal CellCept (ara Sezzjoni 4. 8).
Therefore, CellCept is contraindicated in patients with a hypersensitivity to mycophenolate mofetil or mycophenolic acid.
Għalhekk CellCept huwa kontra- indikat f' pazjenti b' sensittività eċċessiva għal mycophenolate mofetil jew mycophenolic acid.
CellCept is contraindicated in women who are breastfeeding (see section 4.6).
CellCept huwa kontra- indikat f’ nisa li qed ireddgħu (ara sezzjoni 4. 6).
For information on use in pregnancy and contraceptive requirements see section 4.6.
Għal tagħrif dwar l- użu fit- tqala u l- ħtiġijiet ta ’ kontraċezzjoni ara sezzjoni 4. 6.
4.4 Special warnings and precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu.
Patients receiving immunosuppressive regimens involving combinations of medicinal products, including CellCept, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section 4.8).
Pazjenti li qegħdin jirċievu programm ta ’ dożaġġ immunosoppressiv li jinvolvi taħlitiet ta ’ prodotti mediċinali, inkluż CellCept, huma f' riskju akbar li jiżviluppaw limfoma jew tumuri malinni oħra, speċjalment dak tal- ġilda (ara sezzjoni 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 marbut mal- qawwa u t- tul ta ’ l - immunosoppressjoni, aktar milli ma ’ l- użu ta ’ xi sustanza speċifika.
As general advice to minimise the risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Bħala parir ġenerali, sabiex jitnaqqas ir- riskju ta ’ kanċer tal- ġilda, esposizzjoni għax- xemx u dawl UV għandu jkun limitat permezz ta ’ lbies protettiv u bl- użu ta ’ sunscreen b’ fattur ta ’ protezzjoni għoli.
Patients receiving CellCept should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression.
Pazjenti li qed jirċievu CellCept għandhom jiġu avżati biex jirrappurtaw immedjatament xi evidenza ta 'infezzjoni, tbenġil mhux mistenni, emorraġija jew sintomi oħra ta ’ indeboliment tal- mudullun.