qanastek/EMEA-V3 huggingface dataset:
Zarzio is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately.
Zarzio normalment jingħata f’ ċentru ta ’ trattament speċjalizzat, minkejja li pazjenti li jirċievuh b’ injezzjoni taħt il- ġilda jistgħu jinjettaw rwieħhom ladarba jiġu mħarrġa sabiex jagħmlu dan.
How does Zarzio work?
Kif jaħdem Zarzio?
The active substance in Zarzio, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Is- sustanza attiva f’ Zarzio, filgrastim hija simili ħafna għal proteina umana msejjħa stimulazzjoni tal - kolownja granuloċijto (G- CSF).
How has Zarzio been studied?
Kif ġie studjat Zarzio?
Zarzio was studied to show that it is comparable to the reference medicine, Neupogen.
Zarzio ġie studjat biex jiġi muri li huwa komparabbli mal- mediċina ta ’ referenza, Neupogen.
Four studies looked at the levels of neutrophils in the blood in a total of 146 healthy volunteers who received Zarzio or Neupogen.
Erba ’ studji ħarsu lejn il- livelli ta ’ newtrofils fid- demm f’ total ta ’ 146 voluntiera b’ saħħithom li rċevew Zarzio jew Neupogen.
The studies looked at the effects of single and repeated administration of various doses of the medicines, either injected under the skin or infused into a vein.
L- istudji ħarsu lejn l- effetti ta ’ amministrazzjoni ta ’ darba u repetuta f’ dożi varji tal- mediċini, kemm dawk injettati taħt il- ġilda jew infużi fil- vini.
What benefit has Zarzio shown during the studies?
Liema benefiċċju wera Zarzio waqt l- istudji li ġew mwettqa?
Zarzio and Neupogen brought about similar increases in blood neutrophil counts in healthy volunteers over the course of the studies.
Zarzio u Neupogen ġabu żjiediet simili ta ’ numru ta ’ newtrofil fid- demm f’ voluntiera b’ saħħithom matul l- istudji.
This was considered sufficient to demonstrate that the benefits of Zarzio are comparable to those of the reference medicine.
Dan kien ikkunsidrat suffiċjenti sabiex juri li l- benefiċċji ta ’ Zarzio jistgħu jiġu mqabbla ma ’ dawk tal- mediċina ta ’ referenza.
What is the risk associated with Zarzio?
X’ inhu r- riskju assoċjat ma ’ Zarzio?
The most common side effect with Zarzio (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
X' inhu r- riskju assoċjat ma 'Zarzio (li deher f' iktar minn pazjent wieħed minn kull għaxra) hu uġiegħ muskoloskeletali (uġigħ fil- muskoli u fl- għadam).
Other side effects may be seen in more than 1 patient in 10, depending on the condition that Zarzio is being used for.
Effetti sekondarji oħrajn jistgħu jidhru f’ aktar minn pazjent minn għaxra skond il- kondizzjoni li Zarzio jkun użat għaliha.
For the full list of all side effects reported with Zarzio, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrapportati b’ Zarzio, ara l- Fuljett ta ’ Tagħrif.
Zarzio should not be used in people who may be hypersensitive (allergic) to filgrastim or any of the other ingredients.
Zarzio m’ għandux jintuża minn persuni ipersensittivi (allerġiċi) għal filgrastim jew għal xi ingredjenti oħra tiegħu.
Why has Zarzio been approved?
Għaliex ġie approvat Zarzio?
The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Zarzio has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkunsidra li, b’ mod konformi mal- ħtiġijiet tal- Unjoni Ewropea, Zarzio wera li għandu kwalità, sigurtà u effikaċja komparabbli ma ’ dawk ta ’ Neupogen.
The Committee recommended that Zarzio be given marketing authorisation.
Il- Kumitat irrakkomanda li Zarzio jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Zarzio:
Informazzjoni oħra dwar Zarzio:
The European Commission granted a marketing authorisation valid throughout the EU for Zarzio to Sandoz GmbH on 06 February 2009.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Zarzio lil Sandoz GmbH fil- 06 ta ’ Frar 2009.
The full EPAR for Zarzio can be found here.
L- EPAR sħiħ għal Zarzio jista ’ jiġi kkonsultat hawnhekk.
EU/ 1/ 08/ 495/ 003
EU/ 1/ 08/ 495/ 003 EU/ 1/ 08/ 495/ 004
30 MU (60 MU/ ml)
30 MU (60 MU/ ml) 30 MU (60 MU/ ml)
Subcutaneous or intravenous use
Soluzzjoni għall- injezzjoni jew infużjoni Soluzzjoni għall- injezzjoni jew infużjoni
Subcutaneous or intravenous use
Użu għal taħt il - ġilda jew ġol- vini Użu għal taħt il - ġilda jew ġol- vini
Pre-filled Syringe (glass)
Siringa mimlija għal- lest (ħġieġ) Siringa mimlija għal- lest (ħġieġ)
0.5 ml
0. 5 ml 0. 5 ml
10 pre-filled syringes
5 siringi mimlija għal- lest 10 siringi mimlija għal- lest
Pre-filled Syringe (glass)
Siringa mimlija għal- lest (ħġieġ) Siringa mimlija
3 pre-filled syringes
3 siringi mimlija għal- lest 5 siringi mimlija
Pre-filled Syringe (glass)
għal- lest (ħġieġ)
5 pre-filled syringes
għal- lest
Zarzio 30 MU/ 0.5 ml solution for injection or infusion in pre-filled syringe
Zarzio 30 MU/ 0. 5 ml soluzzjoni għall- injezzjoni jew infużjoni f’ siringa mimlija għal- lest
Zarzio is available in strengths of 30 MU/ 0.5 ml and 48 MU/ 0.5 ml.
2 Zarzio hu disponibbli fil- qawwiet ta ’ 30 MU/ 0. 5 ml u 48 MU/ 0. 5 ml.
For up to 4 years, there have been no reports of abnormal haematopoiesis in normal donors.
F’ perjodu ta ’ 4 snin, ma kien hemm l- ebda rapporti ta ’ ematopoiesi anormali f’ donaturi normali.
Nevertheless, a risk of promotion of a
Madankollu, ma jistax jiġi eskluż riskju ta ’ promozzjoni ta ’ klonu majelojde malinn.
Zarzio contains sorbitol.
Zarzio fih sorbitol.
Patients with rare hereditary problems of fructose intolerance should not use this medicinal product.
Pazjenti li għandhom problemi ereditarji rari ta ’ intolleranza għall- fructose, m’ għandhomx jużaw dan il- prodott mediċinali.
In four clinical studies none of the healthy volunteers or cancer patients developed anti-rhG-CSF antibodies (neither binding nor neutralising) upon treatment with Zarzio.
F’ erba ’ studji kliniċi, l- ebda wieħed mill- voluntiera b’ saħħithom jew pazjenti bil- kanċer ma żviluppa antikorpi anti- rhG- CSF (la li jeħlu u lanqas li jinnewtralizzaw) meta ngħataw kura b’ Zarzio.
Zarzio containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Zarzio li fih r- metHuG- CSF (filgrastim) jikkawża żidiet notevoli fl- għadd tan- newtrofili tad- demm periferali fi żmien 24 siegħa, b’ żidiet żgħar fil- monoċiti.
Neutrophils produced in response to filgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
In - newtrofili prodotti b’ rispons għal filgrastim juru funzjoni normali jew imtejba kif muri minn testijiet tal- funzjoni kemotattika u fagoċitika.
Following termination of filgrastim therapy, circulating neutrophil counts decrease by 50% within 1 - 2 days, and to normal levels within 1 - 7 days.
Wara t- tmiem tat- terapija b’ filgrastim, l- għadd tan- newtrofili li jkunu jiċċirkolaw jonqos b’ 50% fi żmien minn jum sa jumejn, u għal- livelli normali żmien 1 - 7 ijiem.
Accordingly, G-CSF has been shown to induce endothelial cell functions related to angiogenesis.
Għaldaqstant, intwera li G- CSF jikkaġuna funzjonijiet taċ- ċelluli endoteljali marbuta mal- anġjoġenesi.
Additionally, G-CSF has been shown to increase neutrophil migration across the vascular endothelium.
Flimkien ma ’ dan, intwera li G- CSF iżid il- migrazzjoni tan- newtrofili minn naħa għall- oħra tal- endothelium vaskulari.
One retrospective European study evaluating the use of G-CSF after allogeneic bone marrow transplantation in patients with acute leukaemias suggested an increase in the risk of GvHD, treatment
Studju retrospettiv Ewropew li evalwa l- użu ta ’ G- CSF wara trapjant alloġeneiku tal- mudullun f’ pazjenti b’ lewkimji akuti, issuġġerixxa żieda fir- riskju ta ’ GvHD, mortalità marbuta mal- kura
13 related mortality (TRM) and mortality when G-CSF was administered.
13 (TRM) u l- mortalità meta ngħata G- CSF.
b
1. 11
Randomised, double-blind, single and multiple dose, crossover studies in 146 healthy volunteers showed that the pharmacokinetic profile of Zarzio was comparable to that of the reference product after subcutaneous and intravenous administration.
Studji crossover, randomised, double- blind, dwar dożi waħidhom u dożi multipli li saru fuq 146 voluntiera b’ saħħithom, urew li l- profil farmakokinetiku ta ’ Zarzio kien komparabbli ma ’ dak tal - prodott tar- referenza wara l- għoti taħt il- ġilda u l- għoti ġol- vini.
There is a positive linear correlation between the dose and the serum concentration of filgrastim, whether administered intravenously or subcutaneously.
Hemm korrelazzjoni lineari pożittiva bejn id- doża u l- konċentrazzjoni fis- serum ta ’ filgrastim, kemm jekk jingħata ġol- vina jew taħt il- ġilda.
14 Elimination
14 Eliminazzjoni
Zarzio must not be diluted with sodium chloride solutions.
Zarzio m’ għandux jiġi dilwit b’ soluzzjonijiet ta ’ sodium chloride.
Accidental exposure to freezing temperatures does not adversely affect the stability of Zarzio.
L- espożizzjoni aċċidentali għal temperaturi taħt iż- żero mhux ser taffettwa b’ mod negattiv l- istabbiltà ta ’ Zarzio.
In view of the possible risk of microbial contamination, Zarzio syringes are for single use only.
Minħabba r- riskju possibbli ta ’ kontaminazzjoni mikrobjali, is- siringi b’ Zarzio jintużaw darba biss.
If required, Zarzio may be diluted in glucose 50 mg/ ml (5%) solution.
Jekk ikun meħtieġ, Zarzio jista ’ jiġi dilwit f’ soluzzjoni ta ’ 50 mg/ ml (5%) ta ’ glucose.
Zarzio 48 MU/ 0.5 ml solution for injection or infusion in pre-filled syringe
Zarzio 48 MU/ 0. 5 ml soluzzjoni għall- injezzjoni jew infużjoni f’ siringa mimlija għal- lest
Zarzio is available in strengths of 30 MU/ 0.5 ml and 48 MU/ 0.5 ml.
Zarzio hu disponibbli fil- qawwiet ta ’ 30 MU/ 0. 5 ml u 48 MU/ 0. 5 ml.
29 related mortality (TRM) and mortality when G-CSF was administered.
29 (TRM) u l- mortalità meta ngħata G- CSF.
30 Elimination
30 Eliminazzjoni
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U DETENTURI TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skont il- Linja Gwida CHPM dwar is- Sistemi tal- Immaniġġjar tar- Riskju għal prodotti mediċinali għall- użu uman, l- RMP aġġornat għandu jkun sottomess fl- istess ħin mar- Rapport Perjodiku dwar l - Aġġornament tas- Sigurtà (Periodic Safety Update Report - PSUR) li jkun imiss.
Zarzio 30 MU/ 0.5 ml
Zarzio 30 MU/ 0. 5 ml
Zarzio 48 MU/ 0.5 ml
Zarzio 48 MU/ 0. 5 ml
Zarzio 30 MU/ 0.5 ml injection or infusion
Zarzio 30 MU/ 0. 5 ml injezzjoni jew infużjoni
Zarzio 48 MU/ 0.5 ml injection or infusion
Zarzio 48 MU/ 0. 5 ml injezzjoni jew infużjoni
Zarzio 30 MU/ 0.5 ml solution for injection or infusion in pre-filled syringe Zarzio 48 MU/ 0.5 ml solution for injection or infusion in pre-filled syringe Filgrastim
Zarzio 30 MU/ 0. 5 ml soluzzjoni għall- injezzjoni jew infużjoni f’ siringa mimlija għal- lest Zarzio 48 MU/ 0. 5 ml soluzzjoni għall- injezzjoni jew infużjoni f’ siringa mimlija għal- lest Filgrastim
What Zarzio is and what it is used for 2.
X’ inhu Zarzio u għalxiex jintuża 2.
Before you use Zarzio 3.
Qabel ma tuża Zarzio 3.
How to use Zarzio 4.
Kif għandek tuża Zarzio 4.
How to store Zarzio 6.
Kif taħżen Zarzio 6.
WHAT ZARZIO IS AND WHAT IT IS USED FOR
X’ INHU ZARZIO U GĦALXIEX JINTUŻA
Zarzio contains the active substance filgrastim.
Zarzio fih is- sustanza attiva filgrastim.
If the number of white blood cells is too low (neutropenia), the risk of infection increases.
Jekk in- numru ta ’ ċelluli bojod tad- demm ikun baxx wisq (newtropenja), ir - riskju ta ’ infezzjoni jiżdied.
Zarzio is used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (with fever) which can be caused by the use of cytotoxic anticancer chemotherapy in children and adults.
Zarzio jintuża biex inaqqas it- tul ta ’ żmien ta ’ newtropenja u l- okkorrenza ta ’ newtropenja febbrili (b’ deni) li tista ’ tkun ikkawżata mill- użu ta ’ kimoterapija ċitotossika kontra l- kanċer fit- tfal u fl- adulti.
Zarzio is used to reduce the duration of neutropenia after high-dose chemotherapy and total body irradiation (radiotherapy) followed by bone marrow transplantation, in children and adults at increased risk of prolonged severe neutropenia.
Zarzio jintuża biex inaqqas iż- żmien kemm iddum in- newtropenja wara kimoterapija b’ doża għolja u irradjazzjoni totali tal- ġisem (radjuterapija) segwita minn trapjant tal- mudullun, fit- tfal u fl- adulti li huma f’ riskju miżjud ta ’ newtropenja severa għal żmien twil.
Zarzio is used to stimulate the bone marrow to release (mobilisation) peripheral blood progenitor cells (PBPC, a type of stem cells) into the blood, so that they eventually grow and develop into all types of blood cells: white blood cells, red blood cells and platelets.
Zarzio jintuża biex jistimula l- mudullun biex jerħi (mobilizzazzjoni) ċelluli proġenituri tad- demm periferali (PBPC, tip ta ’ ċelluli staminali) ġod- demm, biex b’ hekk eventwalment jikbru u jiżviluppaw fit- tipi kollha ta ’ ċelluli tad- demm: ċelluli bojod tad- demm, ċelluli ħomor tad- demm u plejtlits.
As chemotherapy and/ or radiotherapy can depress the activity of your bone marrow, this will help to speed up its recovery.
Minħabba li l- kimoterapija u/ jew ir- radjuterapija jistgħu jnaqqsu l- attività tal- mudullun tiegħek, dan ser jgħin biex iħaffef l- irkuprar tiegħu.
If you donate stem cells for another person, the PBPCs will be removed from your blood and given to the recipient after he/ she has received their chemotherapy and/ or radiotherapy.
Jekk tagħmel donazzjoni ta ’ ċelluli staminali għal persuna oħra, il- PBPCs ser jitneħħew mid- demm tiegħek u jingħataw lir- reċipjent wara li hu/ hi jkunu rċivew il- kimoterapija u/ jew ir- radjuterapija tagħhom.
52 Severe chronic neutropenia
52 Newtropenja kronika severa
Zarzio is used in children and adults to increase the number of white blood cells and reduce the occurrence and duration of infections related to specific forms of severe chronic neutropenia: congenital (inborn), cyclic (recurring), or idiopathic (without known cause).
Zarzio jintuża fit- tfal u fl- adulti biex iżid in- numru ta ’ ċelluli bojod tad- demm u jnaqqas l- okkorrenza u t- tul ta ’ żmien ta ’ infezzjonijiet marbuta ma ’ forom speċifiċi ta ’ newtropenja kronika severa: konġenitali (titwieled biha), ċiklika (isseħħ mill- ġdid), jew idjopatika (mingħajr kawża magħrufa).
Zarzio is used to treat persistent neutropenia in patients with advanced HIV infection, in order to reduce the risk of bacterial infections, when other treatments are not appropriate.
Zarzio jintuża għall- kura ta ’ newtropenja persistenti f’ pazjenti b’ infezzjoni avvanzata tal- HIV, sabiex ser inaqqas ir- riskju ta ’ infezzjonijiet batterjali, meta kuri oħrajn ma jkunux adattati.
BEFORE YOU USE ZARZIO
QABEL MA TUŻA ZARZIO
Do not use Zarzio
Tużax Zarzio
- if you are allergic (hypersensitive) to filgrastim or to any of the other ingredients of Zarzio
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal filgrastim jew sustanzi oħra ta ’
(listed in section 6. ‘ What Zarzio contains’).
Zarzio (elenkati f’ sezzjoni 6 ‘ X’ fih Zarzio ’)
Take special care with Zarzio Please tell your doctor:
Oqgħod attent ħafna b’ Zarzio Jekk jogħġbok għid lit- tabib tiegħek:
Driving and using machines Zarzio has no influence on the ability to drive and use machines.
Sewqan u tħaddim ta ’ magni Zarzio m’ għandu l- ebda effett fuq il- ħila biex issuq u tħaddem magni.
Important information about some of the ingredients of Zarzio This medicine contains sorbitol (a type of sugar).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Zarzio Din il- mediċina fiha sorbitol (tip ta ’ zokkor).
HOW TO USE ZARZIO
KIF GĦANDEK TUŻA ZARZIO
The amount of Zarzio you need depends on your bodyweight and the condition you are treated for.
L- ammont ta ’ Zarzio li teħtieġ jiddependi fuq il- piż ta ’ ġismek u l- kundizzjoni li għaliha tkun qed tingħata kura.
The first dose should not be administered less than 24 hours
L- ewwel doża m’ għandhiex tingħata inqas
53 following cytotoxic chemotherapy.
53 minn 24 siegħa wara l- kimoterapija ċitotossika.
Zarzio will be given for 5 - 7 consecutive days.
Zarzio ser jingħata għal perjodu ta ’ 5 - 7 t’ ijiem konsekuttivi.
Treatment with Zarzio should be maintained until the last stem cell collection.
Il- kura b’ Zarzio għandha titkompla sal- aħħar ġbir ta ’ ċelluli staminali.
Zarzio will be given until the expected lowest level of white blood cells is passed and has recovered to the normal range.
Zarzio ser jingħata sakemm l- inqas livell mistenni ta ’ ċelluli bojod tad- demm ikun għadda u jkun irkupra għall- medda normali.
Zarzio treatment will last for 4 - 5 consecutive days.
Il- kura b’ Zarzio iddum għal 4 - 5 t’ ijiem konsekuttivi.
Long-term treatment with Zarzio is required for neutropenia.
Il- kura fit- tul b’ Zarzio hi meħtieġa għan- newtropenja.
Long-term treatment with Zarzio may be required to maintain a normal number of white cells in your blood.
Il- kura fit- tul b’ Zarzio tista ’ tkun meħtieġa biex iżżomm numru normali ta ’ ċelluli bojod fid- demm tiegħek.
How Zarzio is used Always use Zarzio exactly as your doctor has told you.
Kif tuża Zarzio Dejjem għandek tuża Zarzio skont il- parir eżatt tat- tabib.
You should check with your doctor, nurse or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib, l - infermiera jew mal- ispiżjar tiegħek jekk ikollok xi dubju.
This medicine is given by injection into the tissue just under the skin (subcutaneous injection), or through an intravenous infusion (“ a drip”).
Din il- mediċina tingħata permezz ta ’ injezzjoni fit- tessut li hi immedjatment taħt il- ġilda (injezzjoni subkutanea), jew permezz ta ’ infużjoni ġol- vini (“ dripp ”).
Your doctor may decide that it would be more convenient for you to inject Zarzio yourself.
It- tabib tiegħek jista ’ jiddeċiedi li jista ’ ikun aħjar għalik li tinjetta Zarzio inti stess.
Your doctor or nurse will show you how to inject yourself.
It- tabib jew l - infermiera tiegħek ser juruk kif tinjetta lilek innifsek.
Instructions on how to inject yourself with Zarzio can be found at the end of this leaflet.
Struzzjonijiet dwar kif tinjetta Zarzio lilek innifsek, jinsabu fl- aħħar ta ’ dan il- fuljett.
If you use more Zarzio than you should
54 Jekk tuża Zarzio aktar milli suppost
If you have used more Zarzio than you should, contact your nurse, doctor or pharmacist immediately.
Jekk tkun użajt Zarzio aktar milli suppost, ikkuntattja lill- infermeira, lit- tabib jew lill- ispiżjar tiegħek immedjatament.
54 If you forget to use Zarzio
Jekk tinsa tuża Zarzio
If you have forgotten a dose of Zarzio, you should contact your doctor to discuss when you should inject the next dose.
Jekk tkun insejt tieħu doża ta ’ Zarzio, għandek tikkuntattja lit- tabib tiegħek biex tiddiskuti meta għandek tinjetta d- doża li jmiss.
If you stop using Zarzio
Jekk tieqaf tuża Zarzio
Your doctor will tell you when you can stop using Zarzio.
It- tabib tiegħek ser jgħidlek meta tkun tista ’ tieqaf tuża Zarzio.
It is quite normal to have several courses of treatment with Zarzio.
Hu normali għal kollox li jkollok diversi korsijiet tal- kura b’ Zarzio.
Like all medicines, Zarzio can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Zarzio jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Common side effects • diarrhoea • injection site pain • hair loss • rash • enlarged liver • inflammation of blood vessels of the skin • loss of calcium from the bones (osteoporosis) • spleen disorder
Effetti sekondarji komuni • dijarea • uġigħ fis- sit tal- injezzjoni • telf ta ’ xagħar • raxx • il- fwied jikber • infjammazzjoni tal- vini jew arterji fil- ġilda • telf ta ’ calcium mill- għadam (osteoporożi) • disturbi fil- milsa
55 blood pressure, skin rash, nettle rash; these reactions can occur at the start of the treatment or throughout the treatment • worsening of rheumatoid arthritis or arthritic symptoms • blood or protein in the urine
55 Effetti sekondarji mhux komuni • tnaqqis fil- pressjoni tad- demm • reazzjonijiet qishom allerġija, li jinkludu anafilassi (sturdament, tnaqqis sever fil- pressjoni tad - demm, diffikultà biex tieħu n- nifs), anġjoedema (nefħa bl- uġigħ tal- wiċċ jew tal- gerżuma), diffikultà biex tieħu n- nifs, pressjoni tad- demm baxxa, raxx tal- ġilda, jew raxx bħal dak ikkawżat mill- ħurrieq; dawn ir- reazzjonijiet jistgħu jseħħu fil- bidu tal- kura jew matul il- kura • aggravament ta ’ artrite rewmatojde jew sintomi artritiċi • demm jew proteina fl- awrina
HOW TO STORE ZARZIO
KIF TAĦŻEN ZARZIO
Do not use Zarzio after the expiry date which is stated on the carton and on the syringe label after EXP.
Tużax Zarzio wara d- data ta ’ skadenza li tidher fuq il- kartuna fuq it- tikketta tas- siringa wara EXP.
What Zarzio contains
X’ fih Zarzio
Zarzio 30 MU/ 0.5 ml solution for injection or infusion in pre-filled syringe:
Zarzio 30 MU/ 0. 5 ml soluzzjoni għall- injezzjoni jew infużjoni f’ siringa mimlija għal- lest:
Zarzio 48 MU/ 0.5 ml solution for injection or infusion in pre-filled syringe:
Zarzio 48 MU/ 0. 5 ml soluzzjoni għall- injezzjoni jew infużjoni f’ siringa mimlija għal- lest:
What Zarzio looks like and contents of the pack
56 Id- Dehra ta ’ Zarzio u l- kontenuti tal- pakkett
Zarzio is a clear, colourless to slightly yellowish solution for injection or infusion in a pre-filled syringe.
Zarzio hu soluzzjoni ċara u bla kulur jew kemm kemm safra għall- injezzjoni f’ siringa mimlija għal - lest.
Zarzio is available in packs containing 1, 3, 5 or 10 pre-filled syringes with injection needle and with or without a needle safety guard.
Zarzio hu disponibbli f’ pakketti li fihom 1, 3, 5 jew 10 siringi mimlija għal- lest b’ labra tal- injezzjoni bi jew mingħajr protezzjoni tas- sigurtà tal- labra.
56 Not all pack sizes may be marketed.
Mhux id- daqsijiet kollha tal- pakketti jistgħu jitpoġġew fis- suq.
58
58 Lietuva Sandoz Pharmaceuticals d. d filialas eimyni kių g.
This section contains information on how to give yourself an injection of Zarzio.
Din is- sezzjoni fiha tagħrif dwar kif għandek tagħti injezzjoni ta ’ Zarzio lilek innifsek.
Zarzio is provided with or without a needle safety guard and you will be shown how to use this by your doctor or nurse.
Zarzio hu pprovdut bi jew mingħajr protezzjoni tas - sigurtà tal- labra, u t- tabib jew l- infermiera tiegħek ser juruk kif tużaha.
How do I inject myself?
Kif ninjetta lili nnifsi?
A new pre-filled syringe of Zarzio with or without a needle safety guard 2.
Siringa ġdida mimlija għal- lest b’ Zarzio bi jew mingħajr protezzjoni tas- sigurtà tal- labra 2.
A puncture-proof container for disposing of used syringes safely if you use the Zarzio pre-filled syringe without a needle safety guard.
Kontenitur li ma jittaqqabx biex tarmi s- siringi użati b’ mod siġur jekk qed tuża s- siringa mimlija għal- lest ta ’ Zarzio mingħajr protezzjoni tas- sigurtà tal- labra.
What should I do before I give myself a subcutaneous injection of Zarzio?
X’ għandi nagħmel qabel ma nagħti lili nnifsi injezzjoni taħt il- ġilda b’ Zarzio?
Take your Zarzio pack out of the refrigerator.
Oħroġ il- pakkett ta ’ Zarzio mill- friġġ.
Check the appearance of Zarzio.
Iċċekkja d- dehra ta ’ Zarzio.
If it is cloudy or there are particles in it, you must not use it.
Jekk ikun imċajpar jew jekk ikun fih il- partikuli, m’ għadekx tużah.
Do not warm Zarzio in any other way (for example, do not warm it in a microwave or in hot water).
Issaħħanx Zarzio bi kwalunkwe mod ieħor (per eżempju, issaħħnux fil- microwave jew f’ ilma jaħraq).
How do I prepare the injection?
59 Kif għandi nipprepara l- injezzjoni?
Before you inject Zarzio you must do the following:
Qabel ma tinjetta Zarzio, għandek tagħmel dan li ġej:
Push the plunger up to the number (ml) that matches the dose of Zarzio that your doctor prescribed.
Imbotta l- planġer san- numru (ml) li jaqbel mad- doża ta ’ Zarzio li għaliha jkun tak riċetta t- tabib tiegħek.
Check again to make sure the correct dose of Zarzio is in the syringe.
Iċċekkja mill- ġdid biex taċċerta ruħek li jkun hemm id- doża korretta fis- siringa ta ’ Zarzio.
Change the place that you inject each time so you don’ t become sore in one area.
Ibdel il- post li fih tinjetta kull darba biex ma jkollokx uġigħ f’ żona waħda.
Disposal of used syringes
60 Kif tarmi s- siringi użati
60 Pre-filled syringe with needle safety guard
Siringa mimlija għal- lest bi protezzjoni tas- sigurtà tal- labra
When diluted in glucose 50 mg/ ml (5%) solution, filgrastim is compatible with glass and a variety of plastics including polyvinylchloride, polyolefin (a copolymer of polypropylene and polyethylene) and polypropylene.
Meta jkun dilwiti f’ soluzzjoni ta ’ 50 mg/ ml (5%) ta ’ glucose, filgrastim hu kompatibbli mal- ħġieġ u ma ’ varjetà ta ’ plastiks li jinkludu polyvinylchloride, polyolefin (copolymer ta ’ polypropylene u polyethylene) u polypropylene.
Using the pre-filled syringe without a needle safety guard
61 Kif tuża s- siringa mimlija għal- lest mingħajr protezzjoni tas- sigurtà tal- labra
100 mg
Zavesca 100 mg
Hard capsules
Kapsula iebsin
Oral use
U u orali
Blister (Alu/ Aclar)
Folja (Aluminju/ Aclar)
84 hard capsules
84 kapsula iebsin
What is Zavesca?
X’ inhi Zavesca?
Zavesca is a medicine that contains the active substance miglustat.
Zavesca hija mediċina li fiha s- sustanza attiva miglustat.
It is available as white capsules (100 mg).
Tinsab bħala kapsula bajda għal użu orali.
What is Zavesca used for?
Għalxiex tintuża Zavesca?
Zavesca is used to treat two rare, inherited diseases that affect the way the body handles fats.
Zavesca tintuża għat- trattament ta ’ żewġ mardiet rari li jintirtu, li jaffettwaw kif il- ġisem iħaddem ix - xaħmijiet.
Both diseases cause a build-up of fatty substances called glycosphingolipids in the body.
Iż- żewġ mardiet jikkawwżaw li jinġabru sustanzi xaħmija msejjħa glikosfingolipids fil - ġisem.
Zavesca is used in the following patients:  adults with mild to moderate type 1 Gaucher disease.
Zavesca jintu¿ aw f’ dawn il- pazjenti li ġejjin: is used in the following patients:  adulti b’ tip 1 tal- marda Gaucher fi stadju ħafif għal moderat.
Patients with this disease lack an enzyme called glucocerebrosidase, resulting in a glycosphingolipid called glucosylceramide building up in different parts of the body, such as the spleen, liver and bones.
Pazjenti b’ din il- marda għandhom nuqqas ta ’ enzim imsajjaħ glukoċerebrosidażi,, li jwassal għal żieda fil- livell ta ’ sustanza glukosilċeramide f’ partijiet differenti tal- ġisem, bħall- milsa, il- fwied u l- għadam.
Zavesca is used in patients who cannot receive the standard treatment of enzyme replacement therapy (ERT) given by infusion (drip into a vein);  adults, adolescents and children with Niemann-Pick type C disease, a potentially fatal disease in which glycosphingolipids build up within cells in the brain and elsewhere in the body.
Zavesca jintuża f’ pazjenti li ma jistgħux jirċievu t- trattament standard ta ’ terapija tar- rimpjazzament ta ’ l- enzim (ERT) mogħti permezz ta ’ infużjoni (dripp fil- vina).  adulti, adoloxxenti u tfal bil- marda Niemann- Pick tat- tip Ċ, marda potenzjalment fatali li fiha jakkumulaw il- glikosfingolipids fiċ- ċelloli fil- moħħ u f’ partijiet oħra tal- ġisem.
Zavesca is used to treat the ‘ neurological’ symptoms of the disease (symptoms affecting the brain and nerves).
Zavesca huwa wżat sabiex jittratta s- sintomi ‘ newroloġiċi ’ tal- marda (sintomi li jaffettwaw il- moħħ u n- nervaturi).
These include loss of co-ordination, problems with ‘ saccadic’ (rapid) eye movements that can lead to impaired vision, delayed development, difficulty swallowing, increased muscle tone, fits and learning difficulties.
Dawn jinkludu nuqqas ta ’ koordinazzjoni, problemi b’ movimenti mgħaġġla tal- għajnejn tat- tip saccadic li jistgħu jwasslu għat- telf tal- vista, żvilupp ritardat, problemi biex wieħed jibla ’, żieda fit - ton tal- muskulatura, attakki ta ’ konvulżjoni u problemi fit- tagħlim.
Because the number of patients with these diseases is low, they are considered ‘ rare’, and Zavesca was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 18 October 2000 for type 1 Gaucher disease and on 16 February 2006 for Niemann Pick type C disease.
Billi l- għadd ta ’ pazjenti b’ dawn il- mardiet huwa wieħed baxx, huma kkunsidrati ‘ rari ’, u Zavesca kien ikklassifikat bħala ‘ mediċina orfni ’ (mediċina użata għal mardiet rari) fit- 18 ta ’ Ottubru ta ’ l - 2000 għat- tip 1 tal- marda ta ’ Gaucher u fis- 16 ta ’ Frar għal marda tat- tip Ċ ta ’ Niemann Pick.
How is Zavesca used?
Kif tintuża Zavesca?
Treatment with Zavesca should be started and monitored by doctors who are experienced in the management of Gaucher or Niemann-Pick type C disease.
It- trattament b’ Zavesca għandu jinbeda u jiġi sorveljat minn tobba b’ esperjenza fit- trattament tal - marda ta ’ Gaucher jew il- marda tat- tip C ta ’ Niemann Pick.
The recommended starting dose for type 1 Gaucher disease is one capsule by mouth three times a day.
Id- doża inizjali rakkomandata għat- tip 1 tal- marda ta ’ Gaucher hija kapsula orali tliet darbiet kuljum.
For Niemann-Pick type C disease, the recommended dose is two capsules three times a day for adults and adolescents.
Għal marda tat- tip Ċ ta ’ Niemann Pick, id- doża rakkomandata hija żewġ kapsuli tliet darbiet kuljum għal adulti u għal adoloxxenti.
The dose depends on weight and height in children below 12 years.
Id- doża tiddependi fuq il- piż u fuq it- tul fi tfal taħt it- 12- il sena.
Zavesca can be taken with or without food.
Zavesca tista ’ tittieħed ma ’ jew mingħajr l- ikel.
It is intended for long-term use.
Zavesca hija intenzjonata għal użu fit- tul.
The dose should be reduced in patients with kidney problems and, on a temporary basis, in patients who develop diarrhoea.
Id- do¿ a għandha titnaqqas f’ pazjenti bi problemi fil- kliewi u fuq ba¿ i temporanja, f’ pazjenti li ji¿ viluppaw dijarea.
Zavesca has not been studied in patients with liver problems.
Zavesca ma ġietx studjata f’ pazjenti bi problemi tal- fwied.
For further information, see the Summary of Product Characteristics (also part of the EPAR).
Għal tagħrif sħiħ dwar id- do¿ a, ara s- Sommarju tal- Karatteristiċi tal- Prodott (li wkoll hu parti mill- EPAR).
How does Zavesca work?
Kif taħdem Zavesca?
The active substance in Zavesca, miglustat, prevents an enzyme called glucosylceramide synthase from working.
Is- sustanza attiva f’ Zavesca, miglustast, jipprevjeni enzim (sintażi tal - glukosilċeramide) milli jaħdem.
This enzyme is involved in the first step of the production of glycosphingolipids.
Dan l- enzim huwa involut fl- ewwel pass fil- produzzjoni ta ’ glikosfingolipids.
By preventing the enzyme from working, miglustat can reduce the production of glycosphingolipids in cells.
Billi miglustat jipprevjenti l- enzim milli jaħdem, dan jista ’ jnaqqas il- produzzjoni tal- glikosfingolipids fiċ- ċelloli.
This is expected to slow down or prevent the development of the symptoms of type 1 Gaucher disease and to reduce the symptoms of Niemann-Pick type C disease.
Dan huwa mistenni li jnaqqas il- progressjoni jew jipprevjeni l- iżvilupp tas- sintomi tat- tip 1 tal- marda ta ’ Gaucher u sabiex inaqqas is- sintomi tal- marda tat- tip Ċ ta ’ Niemann Pick.
How has Zavesca been studied?
Kif ġiet studjata Zavesca?
For mild to moderate type 1 Gaucher disease, the effectiveness of Zavesca was investigated in one main study involving 28 patients who were unable or unwilling to receive ERT.
Għal marda ta ’ Gaucher ħafifa għal moderata tat- tip 1l- effikaċja ta ’ Zavesca ġiet investigata fi istudju ewlieni li jinvolvi 28 pazjent li ma setgħux jew ma ridux jingħataw ERT.
The main part of the study lasted for a year, but 13 patients carried on receiving the medicine for a further two years.
L- istudju ewlieni dam sena, iżda 13- il pazjent baqgħu jirċievu l- mediċina għal sentejn oħra.
The study measured if Zavesca had an effect on the size of the liver and spleen, and if it improved blood counts, such as the levels of haemoglobin (a protein found in red blood cells that carries oxygen around the body) and platelet counts (components that help the blood to clot).
L- istudju kejjel jekk Zavesca kellhiex effett fuq id- daqs tal- fwied u l- milsa, u jekk kellhiex xi effetti fuq il- parametri tad- demm, bħall - konċentrazzjoni ta ’ l- emoglobina (proteina fiċ- ċelloli tad- demm ħomor li ġġorr l- ossiġnu) u l- għadd ta ’ pjastrini (komponenti li jgħinu d- demm jagħqad).
For Niemann-Pick type C disease, the effectiveness of Zavesca was studied in one main study involving 31 patients, 12 of whom were less than 12 years old.
Għal marda tat- tip Ċ ta ’ Niemann Pick, l- effikaċja ta ’ Zavesca ġiet studjata fi studju ewlieni li jinvolvi 31 pazjent, 12 minnhom kienu anqas minn 12- il sena.
The study compared the effects of adding Zavesca to standard care (measures used to relieve symptoms) with standard care alone.
L- istudju qabbel l- effetti taż- żieda ta ’ Zavesca għal kura standard (miżuri użati għat- taffija ta ’ sintomi) b’ kura standard biss.
The main measure of effectiveness was the change in the speed at which the patients made saccadic horizontal eye movements after a year, but the study also looked at other neurological symptoms such as the patients ’ ability to swallow and their intellectual function.
Il- kejl prinċipali tal - effikaċja kienet il- bidla fl- għaġla fil- movimenti tal- għajnejn b’ mod orizzontali tat- tip saccadic wara sena, iżda l- istudju ħares ukoll lejn sintomi newroloġiċi oħrajn bħalma huma l- kapaċitajiet tal- pazjenti sabiex jibilgħu u l- funzjoni intellettwali.
Some patients were treated for up to five and a half years.
Xi pazjenti ġew ikkurati sa ħames snin u nofs.
A survey of 66 patients treated with Zavesca was also carried out.
Saret ukoll inkjesta fuq 66 pazjent ittratti b’ Zavesca.
What benefit has Zavesca shown during the studies?
Liema benefiċċju wriet Zavesca waqt l- istudji mwettqa?
In the study of type 1 Gaucher disease, there was a reduction in liver organ size of 12% and a reduction in spleen size of 19% after a year.
Fl- istudju tal- marda tat- tip 1 tal- marda ta ’ Gaucher, kien hemm tnaqqis fid- daqs tal- fwied bi 12% u tnaqqis fid- daqs tal- milsa b’ 19% wara sena.
On average, the levels of haemoglobin increased by 0.26 g per decilitre and platelet counts increased by 8.29 million per millilitre.
Bħala medja, il- konċentrazzjonijiet ta ’ l- emoglobina żdiedu minn 0. 26 g/ dl u l- għadd ta ’ pjastrini żdied b’ 8. 29 × 109/ l.
The benefits of Zavesca were maintained over three years of continuous treatment.
Il- benefiċċji ta ’ Zavesca ġew miżmuma fuq tliet snin ta ’ trattament kontinwu b’ Zavesca.
In the study of Niemann-Pick type C disease, the improvement in eye movements was similar in patients treated with and without Zavesca.
Fl- istudju tal- marda tat- tip Ċ ta ’ Niemann Pick, it- titjib fil- movimenti tal- għajnejn kien simili fil - pazjenti ttrattati b’ Zavesca u mingħajr Zavesca.
However, there were signs of improvement in swallowing ability and intellectual function in the patients treated with Zavesca.
Minkejja dan, kien hemm sinjali ta ’ titjib fil - kapaċitajiet li wieħed jibla ’ u fil- funzjoni intellettwali fil- pazjenti ttrattati b’ Zavesca.
The survey showed that Zavesca led to a stabilisation or a decrease in the rate at which symptoms got worse in about three-quarters of the patients.
L- inkjesta wriet li Zavesca wasslet għal stabilizzazzjoni jew għal tnaqqis fir- rata li biha s- sintomi marru għall- agħar f’ madwar tliet kwarti tal- pazjenti.
What is the risk associated with Zavesca?
X’ inhu r- riskju assoċjat ma ’ Zavesca?
The most common side effects with Zavesca (seen in more than 1 patient in 10) are weight loss, tremor (shaking), diarrhoea, flatulence (gas) and abdominal pain (stomach ache).
L- aktar effetti sekondarji komuni b’ Zavesca (li affettwaw iktar minn pazjent wieħed minn kull 10) huma telf fil- piż, rogħda, dijarea, flatulanza (gass) u uġigħ addominali (fiż- żaqq).
For the full list of all side effects reported with Zavesca, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati ma ’ Zavesca, ara l- Fuljett ta ’ Tagħrif.
Zavesca should not be used in people who may be hypersensitive (allergic) to miglustat or any of the other ingredients.
Zavesca m’ għandux jintuża minn persuni li jistgħu jkunu allerġiċi għal miglustat jew għal xi sustanzi oħra tiegħu.
Why has Zavesca been approved?
Għaliex ġiet approvata Zavesca?
The Committee for Medicinal Products for Human Use (CHMP) decided that Zavesca’ s benefits are greater than its risks for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease for whom ERT is unsuitable, and of progressive neurological manifestations in adult and paediatric patients with Niemann-Pick type C disease.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li, għat- trattament tal- pazjenti adulti bil- marda ta ’ Gaucher tat- tip 1 bil- marda ħafifa jew moderata, il- benefiċċji ta ’ Zavesca huma ikbar mir- riskju f’ dawk li għalihom ma tistax tintuża t- terapija tar- rimpjazzament ta ’ l - enzimi u li juru manifestazzjonijiet newroloġiċi progressivi fl- adulti u f’ pazjenti pedjatriċi bil- marda Niemann- Pick tat- tip Ċ.
The Committee recommended that Zavesca be given marketing authorisation.
Il- Kumitat irrakkomanda li Zavesca tingħata l- awtorizzazzjoni għat- tqegħid fis- suq f’ din l- indikazzjoni ristretta.
Zavesca has been authorised under ‘ Exceptional Circumstances’ because, as the disease is rare, it has not been possible to obtain complete information on the medicine.
Zavesca ġiet awtorizzata taħt “ Ċirkostanzi Eċċezzjonali ”, għax, billi l- marda hija rari, ma kienx possibbli li jinkiseb iktar tagħrif dwar il- mediċina.
Every year, the European Medicines Agency (EMEA) will review any new information that may become available and this summary will be updated as necessary.
Kull sena, l- Aġenzija Ewropea għall- Mediċini (l - EMEA) tirrevedi kwalunkwe tagħrif ġdid li jista 'jinkiseb u dan is- sommarju se jiġi aġġornat kif meħtieġ.
2/ 3 What information is still awaited for Zavesca?
2/ 3 Liema informazzjoni għadha mistennija għal Zavesca?
The company that makes Zavesca will complete the following studies to address the product’ s effectiveness and safety in type 1 Gaucher disease:  a post-marketing plan to inform doctors on how to use Zavesca and to get patients to report information on the safety of the medicine;  a study to follow up patients already in clinical trials, to continue assessment of the medicine’ s safety and effectiveness and to find out more about the neurological aspects of the disease;  a study to look at the effectiveness and safety of Zavesca in patients who switch from ERT;  a further study of the natural history of the disease, together with the European Working Group for Gaucher Disease (EWGGD).
Il- kumpanija li tagħmel Zavesca ser tiffinalizza l- istudji li ġejjin sabiex tindirizza l- effikaċja u s - sigurtà tal- prodott għal marda ta ’ Gaucher tat- tip 1:  Pjan għal wara t- tqegħid fis- suq, sabiex jgħarraf lit- tobba kif jużaw Zavesca u jitlob sabiex pazjenti jirrappurtaw dwar is- sigurtà tal- mediċina,  Studju li jsegwi pazjenti li diġa ’ qed jagħmlu provi kliniċi, sabiex ikomplu jevalwaw is- sigurtà u l - effikaċja tal- mediċina u sabiex jagħmlu aktar sejbiet dwar l- aspetti newroloġiċi tal- marda;  Studju biex iħares lejn l- effikaċja u s- sigurtà ta ’ Zavesca f’ pazjenti li jaqilbu mill- ERT, u,  Studju ieħor dwar l- istorja naturali tal- marda, flimkien mal- Grupp ta ’ Ħidma Ewropew għall - Marda ta ’ Gaucher (EWGGD).
Other information about Zavesca:
Informazzjoni oħra dwar Zavesca:
The European Commission granted a marketing authorisation valid throughout the European Union for Zavesca on 20 November 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Zavesca fl- 20 ta ’ Novembru 2002.
The marketing authorisation holder is Actelion Registration Ltd.
Actelion Registration Ltd. hija d- detentur tal- awtorizzazzjoni għat - tqegħid fis- suq.
The marketing authorisation was renewed on 20 November 2007.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fl- 20 ta ’ Novembru 2007.
The records of Zavesca’ s designation as an orphan medicine are available here (type 1 Gaucher disease) and here (Niemann-Pick type C disease).
Ir- reġistri li juru n- nominazzjoni ta ’ Zavesca bħala mediċina orfni huma disponibbli hawn (b’ tip 1 tal - marda Gaucher) u hawnhekk (marda tat- tip Ċ ta ’ Niemann Pick).
The full EPAR for Zavesca can be found here.
L- EPAR sħiħ għal Zavesca jista ’ jinstab hawn.
Zavesca 100 mg hard capsules.
Zavesca 100mg kapsuli iebsa.
Each capsule contains 100 mg miglustat.
Kull kapsula fiha 100mg ta ’ miglustat
White capsules with “ OGT 918” printed in black on the cap and “ 100” printed in black on the body.
Kapsuli bojod b ’ “ OGT 918 ” miktub bl- iswed fuq l- għatu u “ 100 ” miktub bl- iswed fuq il- korp tal - kapsula.
Zavesca is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease.
4. 1 Indikazzjonijiet terapewtiċi
Zavesca may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable (see sections 4.4 and 5.1).
Zavesca jista ’ jintuża biss għall- kura ta ’ dawk il- pazjenti fejn it - terapija ta ’ sostituzzjoni ta ’ l- enzimi mhijiex adattata (ara sezzjonijiet 4. 4 u 5. 1).
Zavesca is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease (see sections 4.4, and 5.1).
Zavesca huwa indikat għall- kura ta ’ manifestazzjonijiet newroloġiċi progressivi f’ pazjenti adulti u pazjenti pedjatriċi li għandhom il- marda Niemann- Pick ta ’ tip Ċ (ara sezzjonijiet 4. 4, u 5. 1).
Therapy should be directed by physicians who are knowledgeable in the management of Gaucher disease or Niemann-Pick type C disease, as appropriate.
It- terapija għandha tkun immexxija minn tobba li għandhom esperjenza fl- immaniġġjar tal- marda ta ’ Gaucher jew il- marda ta ’ Niemann- Pick ta ’ tip Ċ.
Zavesca can be taken with or without food.
Zavesca jista ’ jittieħed ma ’ l- ikel jew fuq stonku vojt.
Dosage in type 1 Gaucher disease
Dożaġġ fil- marda ta ’ Gaucher ta ’ tip 1
The recommended starting dose for the treatment of adult patients with type 1 Gaucher disease is 100 mg three times a day.
Id- doża tal- bidu rrakkomandata għall- pazjenti adulti bil- marda ta ’ Gaucher ta ’ tip 1 hi ta ’ 100 mg, tliet darbiet kuljum.
Temporary dose reduction to 100 mg once or twice a day may be necessary in some patients because of diarrhoea.
F’ każ ta ’ dijarea, jista ’ jkun hemm bżonn ta ’ tnaqqis temporanju tad- doża għal 100 mg darba jew darbtejn kuljum.
There is no experience with the use of Zavesca in patients with type 1 Gaucher disease under the age of 18.
M’ hemm l- ebda esperjenza dwar l- użu ta ’ Zavesca f’ pazjenti bil- marda ta ’ Gaucher ta ’ tip 1 ta ’ taħt it - 18- il sena.
The use of Zavesca is therefore not recommended in children or adolescents with type 1 Gaucher disease.
Għalhekk, l- użu ta ’ Zavesca mhux irrakkomandat fit- tfal u fl- adoloxxenti bil- marda ta ’ Gaucher ta ’ tip 1.
There is no experience with the use of Zavesca in patients over the age of 70.
M’ hemmx esperjenza klinika bl- użu ta ’ Zavesca f’ pazjenti ta ’ iktar minn 70 sena.
Dosage in Niemann-Pick type C disease
Dożaġġ fil- marda ta ’ Niemann- Pick ta ’ tip Ċ
The recommended dose for the treatment of adult and adolescent patients with Niemann-Pick type C disease is 200 mg three times a day.
Id- doża rrakkomandata għall- kura ta ’ pazjenti adulti u adoloxxenti bil- marda ta ’ Niemann- Pick ta ’ tip Ċ hija 200 mg tliet darbiet kuljum.
Dosing in patients under the age of 12 years should be adjusted on the basis of body surface area as illustrated below:
Dożaġġ f’ pazjenti taħt l- età ta ’ 12- il sena għandu jiġi aġġustat skond l- erja tas- superfiċje tal- ġisem kif indikat isfel:
Body surface area (m2)
Erja tas- superfiċje tal - ġisem (m2)
> 1.25 > 0.88 - 1.25 > 0.73 - 0.88 > 0.47 - 0.73 ≤ 0.47
> 1. 25 > 0. 88 - 1. 25 > 0. 73 - 0. 88 > 0. 47 - 0. 73 ≤ 0. 47
200 mg three times a day 200 mg twice a day 100 mg three times a day 100 mg twice a day 100 mg once a day
200 mg tliet darbiet kuljum 200 mg darbtejn kuljum 100 mg tliet darbiet kuljum 100 mg darbtejn kuljum 100 mg darba kuljum
Temporary dose reduction may be necessary in some patients because of diarrhoea.
Tnaqqis temporanju tad- doża jista ’ jkun neċessarja f’ xi pazjenti minħabba dijarea.
The benefit to the patient of treatment with Zavesca should be evaluated on a regular basis (see section 4.4).
Il- benefiċċju tal- kura b’ Zavesca għall- pazjent għandu jiġi vvalutat fuq bażi regolari (ara sezzjoni 4. 4).
There is limited experience with the use of Zavesca in Niemann-Pick type C disease patients under the age of 4 years.
Hemm esperjenza limitata bl- użu ta ’ Zavesca f’ pazjenti bil- marda ta ’ Niemann- Pick ta ’ tip Ċ taħt l- età ta ’ 4 snin.
Pharmacokinetic data indicate increased systemic exposure to miglustat in patients with renal impairment.
It- tagħrif farmakokinetiku jindika li jkun hemm żjieda fl- espożizzjoni sistemika ta ’ miglustat f’ pazjenti b’ indeboliment tal- kliewi.
In patients with an adjusted creatinine clearance of 50– 70 ml/ min/ 1.73 m2, administration should commence at a dose of 100 mg twice daily in patients with type 1 Gaucher disease and at a dose of 200 mg twice daily (adjusted for body surface area in patients below the age of 12) in patients with Niemann-Pick type C disease.
F’ pazjenti li l- krejatinina tagħhom titneħħa b’ rata aġġustata ta ’ 50– 70 ml/ min/ 1. 73 m2, l- għoti għandu jinbeda b’ doża ta ’ 100 mg darbtejn kuljum f’ pazjenti bil- marda ta ’ Gaucher ta ’ tip 1, u b’ doża ta ’ 200 mg darbtejn kuljum (aġġustata għal erja tas- superfiċje tal- ġisem f’ pazjenti taħt l- età ta ’ 12- il sena) f’ pazjenti bil- marda ta ’ Niemann- Pick ta ’ tip Ċ.
In patients with an adjusted creatinine clearance of 30– 50 ml/ min/ 1.73 m2, administration should commence at a dose of 100 mg once daily in patients with type 1 Gaucher disease and at a dose of 100 mg twice daily (adjusted for body surface area in patients below the age of 12) in patients with Niemann-Pick type C disease.
F’ pazjenti li l- krejatinina tagħhom titneħħa b’ rata aġġustata ta ’ 30– 50 ml/ min/ 1. 73 m2, l- għoti għandu jinbeda b’ doża ta ’ kapsula ta ’ 100 mg darba kuljum f’ pazjenti bil- marda ta ’ Gaucher ta ’ tip 1 u b’ doża ta ’ 100 mg darbtejn kuljum (aġġustata għal erja tas- superfiċje tal- ġisem f’ pazjenti taħt l- età ta ’ 12- il sena) f’ pazjenti bil- marda ta ’ Niemann- Pick ta ’ tip Ċ.
Use in patients with severe renal impairment (creatinine clearance < 30 ml/ min/ 1.73 m2) is not recommended (see sections 4.4 and 5.2).
L- użu f’ pazjenti b’ indeboliment serju tal- kliewi (tneħħija tal- krejatinina ta ’ < 30 ml/ min/ 1. 73 m2) mhuwiex irrakkomandat (ara sezzjonijiet 4. 4 u 5. 2).
Zavesca has not been evaluated in patients with hepatic impairment.
Zavesca ma kienx evalwat f’ pazjenti b’ indeboliment tal- fwied.
Although no direct comparisons with Enzyme Replacement Therapy (ERT) have been performed in treatment-naive patients with type 1 Gaucher disease, there is no evidence of Zavesca having an efficacy or safety advantage over ERT.
Għalkemm ma saru l- ebda paraguni diretti mat- Terapija tas- Sostituzzjoni ta ’ l- Enzimi (Enzyme Replacement Therapy - ERT) f’ pazjenti inkonsapevoli mill- kura bil- marda ta ’ Gaucher ta ’ tip 1, m’ hemmx evidenza li Zavesca għandu vantaġġ fl- effikaċja jew fis- sigurtà fuq l- ERT.
ERT is the standard of care for patients who require treatment for type 1 Gaucher disease (see section 5.1).
L- ERT hi l- kura standard f’ pazjenti li jeħtieġu l- kura għall- marda ta ’ Gaucher ta ’ tip 1 (ara sezzjoni 5. 1).