qanastek/EMEA-V3 huggingface dataset:
Immediately after reconstitution, the product must be further diluted to 100 ml with sodium chloride 9 mg/ ml (0.9%) solution for injection.
Minnufih wara rikonstituzzjoni, il- prodott għandu jiġi dilwit aktar għal 100 ml b' sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni.
- From a 100 ml infusion bag or bottle, withdraw a volume of sodium chloride 9 mg/ ml (0.9%)
- Minn borża għall- infużjoni jew flixkun ta ’ 100 ml, iġbed volum ta '9 mg/ ml (0. 9%) ta ’ soluzzjoni
solution for injection equal to the volume of the reconstituted vials (for 2 vials remove 20 ml, for 3 vials remove 30 ml, for 4 vials remove 40 ml).
għall- injezzjoni ta 'sodium chloride ugwali għall- volum tal- kunjetti rikonstitwiti (għal 2 kunjetti neħħi 20 ml, għal 3 kunjetti neħħi 30 ml, għal 4 kunjetti neħħi 40 ml).
- Slowly add the reconstituted ORENCIA solution from each vial to the infusion bag or bottle using
- Żid bil- mod is- soluzzjoni ta 'ORENCIA rikonstitwita minn kull kunjett għal ġol- borża ta' infużjoni
the same silicone-free disposable syringe provided with each vial.
jew flixkun permezz ta 'l- istess siringa li tintrema wara l- użu bla silikon ipprovduta ma' kull kunjett.
- Gently mix.
- Ħallat bil- mod.
The concentration of the fully diluted ORENCIA solution in the infusion bag or bottle
Il- konċentrazzjoni tas- soluzzjoni ta 'ORENCIA dilwita għal kollox fil- borża ta'
will be approximately 5, 7.5, or 10 mg of abatacept per ml of solution depending on whether 2, 3, or 4 vials of abatacept are used.
infużjoni jew flixkun sejra tkun bejn wieħed u ieħor 5, 7. 5, jew 10 mg ta 'abatacept għal kull ml ta' soluzzjoni jiddependi fuq jekk jintużawx 2, 3 jew 4 kunjetti ta 'abatacept.
- Any unused portion in the vials must be immediately discarded in accordance with local
- Kull porzjon mhux użat fil- kunjett għandu jintrema immedjatament skond ir- rekwiżiti lokali.
When reconstitution and dilution are performed under aseptic conditions ORENCIA infusion solution can be used immediately or within 24 hours if stored refrigerated at 2°C to 8°C.
Meta r- rikonstituzzjoni u d- dilwizzjoni jsiru taħt kundizzjonijiet asettiċi, ORENCIA soluzzjoni għall- infużjoni tista 'tintuża minnufih jew fi żmien 24 siegħa jekk maħżuna fi friġġ f' temperatura ta' bejn 2°C u 8°C.
Prior to administration, the ORENCIA solution should be inspected visually for particulate matter and discolouration.
Qabel l- għoti, is- soluzzjoni ta ’ ORENCIA għandha tiġi spezzjonata viżwalment għal xi frak jew telf tal- kulur.
Discard the solution if any particulate matter or discolouration is observed.
Armi s- soluzzjoni jekk jiġu osservati xi frak jew telf tal- kulur.
The entire, fully diluted ORENCIA solution should be administered over a period of 30 minutes and must be administered with an infusion set and a sterile, non-pyrogenic, low-protein-binding filter (pore size of 0.2 to 1.2 μ m).
Is- soluzzjoni kollha ta ’ ORENCIA, dilwita għal kollox għandha tingħata fuq perijodu ta '30 minuta u għandha tingħata b' sett ta' l- infużjoni u filtru b' livell baxx ta 'tagħqid mal- proteini, mhux piroġeniku u sterili (daqs tal- pora ta' 0. 2 sa 1. 2 μm).
- Do not store any unused portion of the infusion solution for reuse.
- Ma għandek taħżen ebda prozjon mhux użat tas- soluzzjoni għall- infużjoni għal użu darb’ oħra.
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom
Bristol- Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH Ir- Renju Unit
Detailed information on this 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 /
Name and address of the manufacturers of the biological active substance
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
Contrada Fontana del Ceraso 03012 Anagni Italy
Contrada Fontana del Ceraso 03012 Anagni L- Italja
The CHMP considered that a Patient Alert Card should be provided and this is included in Annex III.
Is- CHMP qieset li għandha tkun provduta Kartuna ta ’ Twissija għall- Pazjent u din hija nkluża f’ Anness III.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market.
Sistema ta ’ farmakoviġilanza Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għandu jiżgura li jkun hemm sistema ta ’ farmakoviġilanza u din tkun fis- seħħ qabel ma ’ l- prodott jitpoġġa fis- suq.
Risk Management plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Pjan ta ’ l- immaniġġar tar- Riskji Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq jikkommetti ruħu li jwettaq l- istudji u l - attivitajiet ta ’ farmakoviġilanza addizzjonali mogħtija fid- dettall fil- Pjan ta ’ Farmakoviġilanza.
An updated Risk Management Plan should be provided as per CHMP Guideline on Risk Management Systems for medicinal products for human use.
Pjan ta ’ l- immaniġġar tar- Riskji aġġornat għandu jkun provdut skond il- Linja Gwida tas- CHMP dwar is- Sistemi ta ’ l- immaniġġar tar- Riskji għal prodotti mediċinali għal użu mill- bniedem.
17 ANNEX III
18 ANNESS III
ORENCIA 250 mg powder for concentrate for solution for infusion Abatacept
ORENCIA 250 mg trab għal konċentrat għal soluzzjoni għall- infużjoni Abatacept
Each vial contains 250 mg abatacept.
Kull kunjett fih 250 mg ta 'abatacept.
Excipients: maltose, sodium dihydrogen phosphate monohydrate and sodium chloride
Sustanzi mhux attivi: maltose, sodium dihydrogen phosphate monohydrate u sodium chloride
Powder for concentrate for solution for infusion
Trab għal konċentrat għal soluzzjoni għall- infużjoni.
1 vial 1 sterile silicone-free syringe
kunjett 1 siringa 1 sterili bla silikon
2 vials 2 sterile silicone-free syringes
2 kunjetti 2 siringi sterili bla silikon
3 vials 3 sterile silicone-free syringes
3 kunjetti 3 siringi sterili bla silikon
Intravenous use after reconstitution and dilution Read the package leaflet before reconstitution and use.
Użu għal ġol- vina wara rikostituzzjoni u dilwizzjoni Aqra l- fuljett ta 'tagħrif qabel ir- rikostituzzjoni u l- użu.
Use the silicone-free disposable syringe included in the package for reconstitution.
Uża siringa bla silikon li tintrema wara l- użu inkluża fil- pakkett għar- rikostituzzjoni.
20 Read the package leaflet for the shelf-life of the reconstituted product.
21 Aqra l- fuljett ta ’ tagħrif biex tkun taf kemm idum tajjeb il- prodott rikostitwit.
TRAY LABEL
TIKKETTA TAT- TILAR
NAME OF THE MARKETING AUTHORISATION HOLDER
ISEM TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FUS- SUQ
ORENCIA 250 mg powder for concentrate for solution for infusion Abatacept Intravenous use
ORENCIA 250mg trab għal konċentrat għal soluzzjoni għall- infużjoni Abatacept Użu għal ġol- vini
250 mg of abatacept
250 mg ta ’ abatacept
23 PATIENT ALERT CARD TEXT
24 IL- KITBA TAL- KARTUNA TA ’ TWISSIJA GĦALL- PAZJENT
Orencia Patient Alert Card
Kartuna ta ’ Twissija għall- Pazjent dwar Orencia
Infections
Infezzjonijiet − Jekk tiżviluppa sintomi li jissuġġerixxu
This alert card contains important safety information that you need to be aware of before you are given ORENCIA and during treatment with ORENCIA. • Show this card to any doctor involved in
li hemm xi infezzjonijiet, bħal deni,
−
importanti dwar is- sigurtà li inti trid tkun taf qabel tingħata ORENCIA u matul t- trattament b’ ORENCIA. • Uri din il- kartuna lil kwalunkwe tabib
If you develop symptoms suggestive of infections, such as fever, persistent cough, weight loss, or listlessness, seek medical attention immediately.
sogħla persistenti, telf fil- piż, jew nuqqas ta ’ attenzjoni, fittex attenzjoni medika minnufih.
your treatment.
involut fit- trattament tiegħek.
Dates of ORENCIA Treatment:
Dati tat- Trattament b’ ORENCIA:
Infections Start:
Infezzjonijiet Bidu:
Most recent:
ORENCIA iżid ir- riskju li int tieħu infezzjoni. ____________________
- You should not be treated with ORENCIA
- M’ għandekx tiġi ttrattat/ a b’ ORENCIA
if you have severe infection. - You should be screened for certain infections prior to treatment with
L- aktar reċenti: jekk għandek infezzjoni serja.
____________________
- Għandek tiġi ċċekkjat/ a għal ċerti ____________________
ORENCIA, according to relevant guidelines.
ORENCIA, skond linji gwida relevanti. • Ara l- fuljett ta ’ tagħrif ta ’ ORENCIA għal aktar informazzjoni.
Tuberculosis (TB):
Tuberkolożi (TB):
The safety of ORENCIA in individuals with latent TB is unknown.
Is- sigurtà ta ’ ORENCIA • Jekk jogħġbok kun żgur li jkollok miegħek
You should be screened for TB
b’ TB
• See the ORENCIA package leaflet for more information. • Please make sure you also have a list of all your other medicines with you at any visit to a health care professional.
ukoll lista tal- mediċini kollha l- oħra
prior to ORENCIA treatment.
magħrufa.
It is very Patient’s Name: ____________________ important that you tell your doctor if you Doctor’ s Name: ____________________ have ever had TB, or if you have been in close contact with someone who has had TB.
Huwa lil professjonista tal- kura tas- saħħa. importanti ferm li tgħid lit- tabib tiegħek jekk qattx kellek TB, jew jekk kontx f’ kuntatt Isem tal- Pazjent: ____________________
Doctor’s Phone: ____________________ Hepatitis:
Epatite:
Anti-rheumatic therapies have been associated with hepatitis B reactivation.
Terapiji anti rewmatiċi kienu Telefon assoċjati ma ’ ri- attivazzjoni ta ’ l- epatite B.
Keep this card with you for 3 months after the You should be screened for viral hepatitis in last ORENCIA dose, since side effects may
Għandek tiġi ċċekkjat/ a għal epitate virali
accordance with published guidelines.
Isem tat- Tabib: ____________________ tat- Tabib: ____________________
occur a long time after your last dose of ORENCIA.
skond il- linji gwida ppubblikati.
PACKAGE LEAFLET
Żomm din il- kartuna miegħek għal 3 xhur wara l- aħħar doża ta ’ ORENCIA, minħabba li jistgħu jseħħu effetti sekondarji wara l- aħħar doża tiegħek ta ’ ORENCIA.
25 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF
INFORMATION FOR THE USER ORENCIA 250 mg powder for concentrate for solution for infusion Abatacept
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA ORENCIA 250 mg trab għal konċentrat għal soluzzjoni għall- infużjoni Abatacept
Read all of this leaflet carefully before you start using this medicine.
Aqra dan il- fuljett kollu qabel tibda tieħu din il- mediċina.
What ORENCIA is and what it is used for 2.
X' inhu ORENCIA u għalxiex jintuża 2.
Before you use ORENCIA 3.
Qabel ma tuża ORENCIA 3.
How to use ORENCIA 4.
Kif għandek tuża ORENCIA 4.
Possible side effects 5 How to store ORENCIA 6.
Effetti sekondarji li jista ’ jkollu 5 Kif taħżen ORENCIA 6.
WHAT ORENCIA IS AND WHAT IT IS USED FOR
X' INHU ORENCIA U GĦALXIEX JINTUŻA
ORENCIA is an infusion treatment for adults with moderate to severe rheumatoid arthritis and is used in combination with a medicine called methotrexate.
ORENCIA huwa trattament b' infużjoni għall- adulti b' artrite tar- rewmatiżmu u jintuża flimkien ma 'mediċina msejjħa methotrexate.
The active ingredient of ORENCIA, abatacept, is a protein produced in cell cultures.
Is- sustanza attiva ta 'ORENCIA, abatacept, hija proteina magħmula f' kolturi ta' ċelluli.
Rheumatoid arthritis is a long-term progressive systemic disease that, if untreated, can lead to serious consequences, such as joint destruction, increased disability and impairment of daily activities.
Artrite tar- rewmatiżmu hija marda progressiva sistematika u fit- tul li, jekk ma tiġix ittrattata, tista 'twassal għal konsegwenzi serji, bħall- qerda tal- ġogi, żieda fid- disabilità u diffikultà biex twettaq l - attivitajiet ta' kuljum.
In people with rheumatoid arthritis the body's own immune system attacks normal body tissues, leading to pain and swelling of the joints.
F' nies b' artrite tar- rewmatiżmu, is- sistema immuni tal- ġisem stess tattakka t - tessuti normali tal- ġisem, u dan iwassal għal uġigħ u nefħa tal- ġogi.
This can cause joint damage.
Dan jista 'jikkawża ħsara fil- ġogi.
ORENCIA lessens the immune system's attack on normal t issues by interfering with the immune cells (called T lymphocytes) that contribute to the development of rheumatoid arthritis.
ORENCIA jnaqqas l- attakk tas- sistema immuni fuq it- tessuti normali billi jinterferixxi maċ- ċelluli ta 'l- immunità (imsejħa limfoċiti T) li jikkontribwixxu għall- iżvilupp ta' artrite tar- rewmatiżmu.
ORENCIA is used after another group of medicines called TNF blockers.
ORENCIA jintuża wara grupp ta 'mediċini ieħor imsejħa aġenti li jimblokkaw TNF.
ORENCIA is used to:
ORENCIA jintuża biex:
- slow down the damage to your joints
- jagħmel li l- ħsara fuq il- ġogi tiegħek ddum iktar biex isseħħ
- improve your physical function
- itejjeb il- funzjoni fiżika tiegħek
BEFORE YOU USE ORENCIA
QABEL MA TUŻA ORENCIA
Do not use ORENCIA If you are allergic (hypersensitive) to abatacept or any of the other ingredients.
Tużax ORENCIA Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal abatacept jew sustanzi oħra ta 'ORENCIA.
If you have a severe or uncontrolled infection, therapy with ORENCIA must not be started.
Jekk għandek infezzjoni serja jew mhux ikkontrollata, it- terapija b' ORENCIA ma għandhiex tinbeda.
Having an infection could put you at risk of serious side effects from ORENCIA.
Jekk ikollok infezzjoni, dan jista 'jpoġġik f' riskju ta' effetti sekondarji serji ta ’ ORENCIA.
Take special care with ORENCIA If you experience allergic reactions such as chest tightness, wheezing, severe dizziness or lightheadedness, swelling or skin rash tell your doctor immediately.
Oqgħod attent ħafna b' ORENCIA Jekk tesperjenza reazzjonijiet allerġiċi bħal tagħfis fis- sider, tħarħir, sturdamenti qawwija jew sturdamenti oħra, nefħa jew raxx tal- ġilda avża lit- tabib tiegħek minnufih.
If you have any kind of infection, including long-term or localised infection, or often get infections.
Jekk għandek kwalunkwe tip ta 'infezzjoni, inkluż infezzjoni fit- tul jew lokalizzata, jew jekk tieħu infezzjonijiet ta' spiss.
It is important you tell your doctor if you have symptoms of infection (e.g. fever, malaise, dental problems).
Huwa importanti li tavża lit- tabib tiegħek jekk għandek xi sintomu ta 'infezzjoni (eż. deni, telqa, problemi dentali).
ORENCIA also can lower your body's ability to fight infection and the treatment can make you more prone to getting infections or make any infection you have worse.
ORENCIA jista 'wkoll ibaxxi l- abbiltà ta' ġismek li jiġġieled kontra infezzjoni u t- trattament jista 'jagħmlek iktar suxxettibbli li tieħu infezzjoni jew jiggrava xi infezzjoni li diġà għandek.
If you have had tuberculosis (TB) or have symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever) tell your doctor.
27 Jekk kellek it- tuberkolożi (TB) jew jekk għandek sintomi ta 'tuberkolożi (sogħla persistenti, telf fil- piż, nuqqas ta' konċentrazzjoni, deni ħafif) avża lit- tabib tiegħek.
Before you use ORENCIA, your doctor will examine you for tuberculosis or do a skin test.
Qabel ma tuża ORENCIA, it- tabib tiegħek jeżaminak għat- tuberkolożi jew jagħmillek test tal- ġilda.
26 If you have viral hepatitis tell your doctor.
Jekk għandek epatite virali avża lit- tabib tiegħek.
Before you use ORENCIA, your doctor may examine you for hepatitis.
Qabel ma tuża ORENCIA, it- tabib tiegħek jista 'jeżaminak għall- epatite.
If you have cancer.
Jekk għandek kanċer.
Your doctor will have to decide if you can still be given ORENCIA.
It- tabib tiegħek ikollu jiddeċiedi jekk tistax tingħata ORENCIA xorta waħda.
If you recently had a vaccination or are planning to have one.
Jekk tlaqqamt reċentament jew jekk qed tippjana li titlaqqam.
Some vaccines should not be given while receiving ORENCIA.
Xi tilqim m’ għandux jingħata waqt li tkun qed tirċievi ORENCIA.
Check with your doctor before you receive any vaccines.
Ikkonsulta mat- tabib tiegħek qabel tirċievi xi tilqima.
If you are using a blood glucose monitor to check your blood glucose levels.
Jekk qed tuża monitor tal- glucose fid- demm biex tiċċekkja l- livelli tal- glucose fid- demm.
ORENCIA contains maltose, which is a type of sugar that can give falsely high blood glucose readings with certain types of blood glucose monitors.
ORENCIA fih maltose, li huwa tip ta 'zokkor li jista', b' mod falz, jagħti qari ta 'livell għoli ta' glucose fid- demm b' ċerti tipi ta 'monitors tal- glucose fid- demm.
Your doctor may recommend a different method for monitoring your blood glucose levels.
It- tabib tiegħek jista 'jirrikmanda metodu differenti għall- monitoraġġ tal- livelli ta' glucose fid- demm tiegħek.
ORENCIA and older people ORENCIA can be used by people over 65 with no change in dose.
ORENCIA u persuni anzjani ORENCIA jista 'jintuża minn persuni li għandhom iktar minn 65 sena mingħajr ma jkun hemm bżonn ta' bidla fid- doża.
Since the elderly are more susceptible to infections and cancer, ORENCIA should be used with caution in this patient population.
Minħabba li l- anzjani huma aktar suxxettibbli għall- infezzjonijiet u għall- kanċer, ORENCIA għandu jintuża bi prudenza f' din il- popolazzjoni ta 'pazjenti.
ORENCIA and children / adolescents ORENCIA has not been studied in patients under 18 years of age, therefore ORENCIA is not recommended in this patient population.
ORENCIA u tfal / adoloxxenti ORENCIA ma ġiex studjat f' pazjenti taħt it- 18- il sena, għalhekk ORENCIA m' huwiex rakkomandat f' din il- popolazzjoni ta 'pazjenti.
ORENCIA is not to be used with biological medicines for rheumatoid arthritis including adalimumab, etanercept, and infliximab; there is insufficient evidence to recommend co- administration with anakinra and rituximab.
ORENCIA m’ għandux jintuża flimkien ma 'mediċini bijoloġiċi għall- artrite tar- rewmatiżmu inkluż adalimumab, etanercept, u infliximab; m' hemmx biżżejjed evidenza biex jingħata flimkien ma' anakinra u rituximab.
ORENCIA can be taken with other medicines commonly used in the treatment of rheumatoid arthritis, such as steroids or painkillers including non-steroidal anti-inflammatories such as ibuprofen or diclofenac.
ORENCIA jista 'jittieħed ma' mediċini oħra li jintużaw b’ mod komuni fit- trattament ta 'artrite tar - rewmatiżmu, bħal sterojdi jew mediċini għal kontra l- uġigħ inkluż anti- infjammatorji li m’ humiex sterojdi bħalma huma ibuprofen jew diclofenac.
Ask your doctor or pharmacist for advice before taking any other medicine while using ORENCIA.
Staqsi lit- tabib jew lill- ispiżjar tiegħek għal parir qabel tibda tieħu xi mediċina oħra meta tkun qed tieħu ORENCIA.
Pregnancy and breast-feeding The effects of ORENCIA in pregnancy are not known, so do not use ORENCIA if you are pregnant unless your doctor specifically recommends it.
Tqala u Treddigħ L- effetti ta 'ORENCIA fit- tqala m' humiex magħrufin, għalhekk tużax ORENCIA jekk inti tqila sakemm ma jkunx it- tabib tiegħek li speċifikament jirrikmandalek li tuża ORENCIA.
Pregnancy must be avoided while using ORENCIA.
Waqt li tkun qed tuża ORENCIA għandek tevita li tinqabad tqila.
Your doctor will advise you on adequate contraceptive methods while using ORENCIA and up to 14 weeks after the last dose.
It- tabib tiegħek jagħtik parir fuq metodi ta 'kontraċezzjoni adegwati meta tuża ORENCIA u sa 14- il ġimgħa wara l- aħħar doża.
If you become pregnant while using ORENCIA, tell your doctor.
Jekk tinqabad tqila fil- perijodu li tkun qed tuża ORENCIA, għid lit- tabib tiegħek.
It is not known whether abatacept, the active ingredient, passes into human milk.
M' huwiex magħruf jekk abatacept, is- sustanza attiva, tgħaddix fil- ħalib uman.
You must stop breast-feeding if you are being treated with ORENCIA and for up to 14 weeks after the last dose.
Għandek twaqqaf it - treddigħ jekk qiegħda tiġi ttrattata b' ORENCIA u sa 14- il ġimgħa wara l- aħħar doża.
Driving and using machines If you are feeling tired or unwell after receiving ORENCIA, you should not drive or operate any machinery.
Sewqan u tħaddim ta 'magni Jekk tħossok għajjien/ a jew jekk ma tħossokx tajjeb/ tajba wara li tirċievi ORENCIA, m’ għandekx issuq jew tħaddem ebda magna.
It is not known if ORENCIA will affect the ability to drive or use machines.
M' huwiex magħruf jekk ORENCIA jaffettwax l- abbiltà li ssuq jew tuża magni.
Important information about some of the ingredients of ORENCIA This medicine contains 1.5 mmol (or 34.5 mg) sodium per maximum dose of 4 vials (0.375 mmol or 8.625 mg sodium per vial).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ ORENCIA Din il- mediċina fiha 1. 5 mmol (or 34. 5 mg) sodium f’ doża massima ta ’ 4 kunjetti (0. 375 mmol jew 8. 625 mg sodium f’ kull kunjett).
To be taken into consideration by patients on a controlled sodium diet.
Dan għandu jiġi kkunsidrat minn pazjenti fuq dieta bis- sodium ikkontrollat.
HOW TO USE ORENCIA
KIF GĦANDEK TUŻA ORENCIA
ORENCIA is supplied as a powder for solution for infusion.
ORENCIA huwa fornut bħala trab għal soluzzjoni għall- infużjoni.
This means that before ORENCIA is given to you, it is first dissolved in water for injections, then further diluted with sodium chloride 9 mg/ml (0.9%) solution for injection.
Dan ifisser li qabel ma ORENCIA jingħatalek, l- ewwel jiddewweb fl- ilma għall- injezzjonijiet, imbagħad jiġi dilwit iktar b' sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni.
27 The recommended dose of abatacept given to you is based on your body weight:
Id- doża rakkomandata ta 'abatacept mogħtija lilek hija bbażata fuq il- piż ta' ġismek:
Your weight
Il- piż tiegħek
Less than 60 kg 60 kg - 100 kg More than 100 kg
Inqas minn 60 kg 60 kg – 100 kg
How ORENCIA is given to you
Kif jingħatalek ORENCIA
ORENCIA is given to you into a vein, usually in your arm, over a period of 30 minutes.
ORENCIA jingħatalek ġol- vina, normalment fi driegħ, fuq perijodu ta '30 minuta.
This procedure is referred to as an infusion.
Din il- proċedura tissejjaħ infużjoni.
Healthcare professionals will monitor you while you receive your ORENCIA infusion.
Il- professjonisti fil- qasam mediku jimmonitorjawk waqt li tirċievi ORENCIA b' infużjoni.
How often ORENCIA is given to you ORENCIA should be given to you again, 2 and then 4 weeks after the first infusion.
Kemm- il darba jingħatalek ORENCIA ORENCIA għandu jingħatalek mill- ġdid, ġimagħtejn u mbagħad 4 ġimgħat wara l- ewwel infużjoni.
After that you will receive a dose every 4 weeks.
Wara, tirċievi doża kull 4 ġimgħat.
Your doctor will advise you on the duration of treatment and what other medications you may continue to take while on ORENCIA.
It- tabib tiegħek jagħtik parir fuq kemm għandu jdum it- trattament u xi trattamenti oħrajn tista 'tibqa' tieħu waqt li tkun qed tieħu ORENCIA.
If you use more ORENCIA than you should In case this happens, your doctor will monitor you for any signs or symptoms of side effects, and treat these symptoms if necessary.
Jekk tuża ORENCIA aktar milli suppost Fil- każ li jseħħ dan, it- tabib tiegħek jimmonitorjak għal kwalunkwe sinjal jew sintomu ta 'effetti sekondarji, u jittratta dawn is- sintomi jekk ikun hemm bżonn.
If you forget to use ORENCIA If you miss receiving ORENCIA when you are supposed to, ask your doctor when to schedule your next dose.
Jekk tinsa tuża ORENCIA Jekk ma tieħux ORENCIA meta suppost tagħmel dan, staqsi lit- tabib tiegħek meta għandek tieħu d - doża li jmiss.
If you stop using ORENCIA The decision to stop using ORENCIA should be discussed with your doctor.
Jekk tieqaf tuża ORENCIA Id- deċiżjoni li tieqaf tuża ORENCIA għandha tiġi diskussa mat- tabib tiegħek.
Like all medicines, ORENCIA can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, ORENCIA jista 'jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The most common side effects with ORENCIA are headache and nausea.
L- aktar effetti sekondarji komuni b' ORENCIA huma wġigħ ta 'ras u nawsja.
Like all medicines that affect your immune system, ORENCIA can cause serious side effects, which may need treatment.
Bħall- mediċini kollha li jaffettwaw is- sistema immuni tiegħek, ORENCIA jista 'jikkawża effetti sekondarji serji, li jistgħu jkunu jeħtieġu trattament.
Possible serious side effects include serious infections, malignancies and allergic reactions.
Effetti sekondarji serji li jista 'jkollu jinkludu infezzjonijiet serji, reazzjonijiet malinni u allerġiċi.
Tell your doctor immediately if you notice any of the following:
Għid lit- tabib tiegħek minnufih jekk tinnota xi sintomu minn dawn li ġejjin:
Severe rash, hives or other signs of allergic reaction Swollen face, hands, feet Trouble breathing or swallowing
Raxx qawwi, ħorriqija jew sinjali oħra ta 'reazzjoni allerġika Nefħa fil- wiċċ, idejn, saqajn Problemi biex tieħu n- nifs jew biex tibla'
Tell your doctor as soon as possible if you notice any of the following:
Għid lit- tabib tiegħek minnufih jekk tinnota xi sintomu minn dawn li ġejjin:
Signs of infection such as fever, malaise, dental problems, burning sensation during urination, painful skin rash, painful skin blisters, coughing
Sinjali ta 'infezzjoni bħal deni, telqa, problemi fis- snien, ħruq waqt l- għamil ta' l- awrina, raxx tal - ġilda bl- uġigħ, nuffati tal- ġilda bl- uġigħ, sogħla
The symptoms described above can be signs of the side effects listed below, all of which have been observed with ORENCIA in clinical trials:
Is- sintomi deskritti hawn fuq jistgħu jkunu sinjali ta 'l- effetti sekondarji elenkati hawn taħt, li kollha kemm huma ġew osservati bl- użu ta' ORENCIA fi provi kliniċi:
Very common side effects (at least 1 in 10 patients): headache.
29 Effetti sekondarji komuni ħafna (għallinqas 1 f' 10 pazjenti): uġigħ ta 'ras.
Common side effect (at least 1 in 100 and less than 1 in 10 patients): infections of nose, throat and lungs, urinary infections, painful skin blisters (herpes), rhinitis, dizziness, high blood pressure, flushing, cough, nausea, diarrhoea, upset stomach, abdominal pain, rash, fatigue, weakness and abnormal liver function tests.
Effetti sekondarji komuni (għallinqas 1 f' 100 u inqas minn 1 f' 10 pazjenti): infezzjonijiet ta 'l - imnieħer, gerżuma u pulmun, infezzjonijiet tas- sistema ta' l- awrina, nuffati fil- ġilda bl- uġigħ (herpes), rinite, sturdament, pressjoni tad- demm għolja, fwawar fil- wiċċ, sogħla, nawsja, dijarea, stonku malleb, uġigħ addominali, raxx, għeja, dgħjufija u testijiet anormali tal- funzjoni tal- fwied.
28 Uncommon side effects (at least 1 in 1,000 and less than 1 in 100 patients): tooth infection, infected skin ulcer, nail fungal infection, skin cancer, low blood platelet count, low blood cell counts, allergic reactions, anxiety, numbness, hives, eye inflammation, dry eye, reduced vision, palpitation, rapid heart rate, low heart rate, low blood pressure, hot flush, mouth sores, increased tendency to bruise, hair loss, dry skin, painful joints, pain in the extremities, flu-like illness, increased weight, infusion-related reactions, depression, absence of menstruation, migraine, kidney infection, psoriasis, difficulty in breathing and throat tightness.
Effetti sekondarji mhux komuni (għallinqas 1 f' 1, 000 u inqas minn 1 f' 100 pazjent): infezzjoni tas - snien, ulċera tal- ġilda infettata, infezzjoni tad- dwiefer b' fungus, kanċer tal- ġilda, għadd baxx ta 'plejtlits tad- demm, għadd baxx taċ- ċelluli tad- demm, reazzjonijiet allerġiċi, ansjetà, titrix, ħorriqija, infjammazzjoni ta' l- għajnejn, għajn xotta, indeboliment fil- vista, palpitazzjoni, rata rapida ta 'tħabbit tal- qalb, rata baxxa ta' tħabbit tal- qalb, fwawar, ulċeri fil- ħalq, tendenza akbar għat- tbenġil, telf ta 'xagħar, ġilda xotta, uġigħ fil- ġogi, uġigħ fl- estremitajiet, mard li jixbaħ l- influwenza, żieda fil- piż, reazzjonijiet relatati ma' l- infużjoni, depressjoni, nuqqas ta 'menstwrazzjoni, emigranja, infezzjoni fil - kliewi, psorjasi, diffikultà fit- teħid tan- nifs u sikkatura fil- griżmejn.
Rare side effects (at least 1 in 10,000 and less than 1 in 1,000 patients): blood stream infection.
Effetti sekondarji rari (għallinqas 1 f' 10, 000 u inqas minn 1 f' 1, 000 pazjent): infezzjoni li taffettwa l - fluss tad- demm.
Your doctor may also do tests to examine your blood values.
It- tabib jista 'jagħmillek xi testijiet biex jeżamina l- valuri tad- demm tiegħek.
HOW TO STORE ORENCIA
KIF TAĦŻEN ORENCIA
Do not use after the expiry date which is stated on the label and the carton after EXP.
Tużaħx wara d- data ta 'skadenza li tidher fuq it- tikketta u l- kartuna wara JIS.
After reconstitution and dilution, the infusion solution is stable for 24 hours in a refrigerator, but for bacteriological reasons, it is to be used immediately.
Wara rikostituzzjoni u dilwizzjoni, is- soluzzjoni għall- infużjoni tibqa ’ stabbli għal 24 siegħa fi friġġ, iżda għal raġunijiet batterjoloġiċi, għandha tintuża minnufih.
Do not use ORENCIA if you notice opaque particles, discolouration or other foreign particles present in the infusion solution.
Tużax ORENCIA jekk tinnota frak opaki, telf fil- kulur jew xi frak barranin preżenti fis- soluzzjoni għall- infużjoni.
What ORENCIA contains The active substance is abatacept.
X' fih ORENCIA Is- sustanza attiva hija abatacept.
After reconstitution, each ml contains 25 mg of abatacept.
Wara rikostituzzjoni, kull ml fih 25 mg ta 'abatacept.
The other ingredients are maltose, sodium dihydrogen phosphate monohydrate and sodium chloride.
Is- sustanzi l- oħra huma maltose, sodium dihydrogen phosphate monohydrate u sodium chloride.
What ORENCIA looks like and contents of the pack ORENCIA powder for concentrate for solution for infusion is a white to off-white powder that can appear solid or broken into pieces.
Id- dehra ta 'ORENCIA u d- daqs tal- pakkett ORENCIA trab għal soluzzjoni għall- infużjoni huwa trab bajdani għal offwajt li jista' jidher solidu jew maqsum f' biċċiet.
ORENCIA is available in packs of either 1, 2 or 3 vials and is supplied with respectively 1, 2 or 3 silicone-free syringes.
30 ORENCIA huwa disponibbli f' pakketti ta 'kunjett 1, 2 jew 3 u huwa fornut rispettivament flimkien ma' 1, 2 jew 3 siringi li huma bla silikon.
29 Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Id- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
Contrada Fontana del Ceraso I-03012 Anagni-Frosinone Italy
Contrada Fontana del Ceraso I- 03012 Anagni- Frosinone L- Italja
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta 'l- awtorizzazzjoni għat- tqegħid fis- suq.
BRI STOL-MYERS SQUIBB PHARMACEUTICALS LTD BRISTOL-MYERS SQUIBB SPOL.
BRISTOL- MYERS SQUIBB PHARMACEUTICALS LTD
This leaflet was last approved in (MM/YYYY)
Dan il- fuljett kien approvat l- aħħar f ’ (XX/ SSSS)
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta 'l- Aġenzija Ewropea dwar il - mediċini (EMEA): http: // www. emea. europa. eu /
The following information is intended for medical or healthcare professionals only
It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku
Reconstitution and dilution should be performed in accordance with good practices rules, particularly with respect to asepsis.
Ir- rikostituzzjoni u d- dilwizzjoni għandhom isiru skond regoli ta 'prattika tajba, b' mod partikolari fir - rigward ta' asepsi.
Dose selection: see section 3 ‘How to use ORENCIA’ of the Package Leaflet
Għażla tad- doża: ara sezzjoni 3 ‘ Kif għandek tuża ORENCIA ’ tal- Fuljett ta ’ Tagħrif.
Reconstitution of vials: under aseptic conditions, reconstitute each vial with 10 ml of water for injections, using the silicone-free disposable syringe provided with each vial and an 18-21 gauge needle.
Rikostituzzjoni tal- kunjetti: taħt kundizzjonijiet asettiċi, irrikostitwixxi kull kunjett b' 10 ml ilma għall- injezzjonijiet, billi tuża siringi bla silikon li jintremew wara l- użu pprovduti ma 'kull kunjett u labra b' toqba 18- 21.
Remove the flip-top from the vial and wipe the top with an alcohol swab.
Neħħi t- tapp li jinfetaħ b’ daqqa ta ’ saba ’ mill- kunjett u imsaħ il- parti ta 'fuq bi swab bl- alkoħol.
Insert the syringe needle into the vial through the centre of the rubber stopper and direct the stream of water for injections to the glass wall of the vial.
Daħħal il- labra tas- siringa fil- kunjett minn nofs it- tapp tal- gomma u dderieġi l- ilma għall- injezzjonijiet lejn il- ħġieġ minn ġewwa tal- kunjett.
Do not use the vial if a vacuum is not present.
Tużax il- kunjett jekk ma jkunx hemm vakwu preżenti.
Remove the syringe and needle after 10 ml of water for injections have been injected into the vial.
Neħħi s- siringa u l- labra wara li 10 ml ta 'ilma għall- injezzjonijiet ikun ġie injettat fil- kunjett.
To minimise foam formation in solutions of ORENCIA the vial should be rotated with gentle swirling until the contents are completely dissolved.
Biex tnaqqas il- formazzjoni tar- ragħwa fis- soluzzjonijiet ta 'ORENCIA, il- kunjett għandu jiddawwar b' tidwir ħafif sakemm il- kontenut idub għal kollox.
Do not use prolonged or vigorous agitation.
Tużax aġitazzjoni fit- tul jew bis - saħħa.
Upon complete dissolution of the powder, the vial should be vented with a needle to dissipate any foam that may be present.
Malli t- trab idub għal kollox, għandha tgħaddi l- arja mill- kunjett permezz ta 'labra sabiex titneħħa ragħwa li tista' tkun preżenti.
After reconstitution the solution should be clear and colourless to pale yellow.
Wara rikostituzzjoni, is- soluzzjoni għandha tkun ċara u bla kulur għal safranija ċara.
Do not use if opaque particles, discolouration, or other foreign particles are present.
Tużahx jekk ikun hemm preżenti partikuli opaki, telf fil- kulur, jew xi frak barranin oħra.
31 Preparation of infusion: immediately after reconstitution, dilute the product to 100 ml with sodium chloride 9 mg/ml (0.9%) solution for injection.
32 Preparazzjoni ta 'l- infużjoni: minnufih wara rikostituzzjoni, iddilwa l- prodott għal 100 ml b' sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni.
From a 100 ml infusion bag or bottle, withdraw a volume of 0.9% sodium chloride injection equal to the volume of the reconstituted ORENCIA vials (for 2 vials remove 20 ml, for 3 vials remove 30 ml, for 4 vials remove 40 ml).
Minn borża għall- infużjoni jew flixkun, iġbed volum ta '0. 9% soluzzjoni ta' injezzjoni ta 'sodium chloride ugwali għall- volum tal- kunjetti ta' ORENCIA rikostitwiti (għal 2 kunjetti neħħi 20 ml, għal 3 kunjetti neħħi 3 0ml, għal 4 kunjetti neħħi 40 ml).
Slowly add the reconstituted ORENCIA solution from each vial to the infusion bag or bottle using the same silicone-free disposable syringe provided with each vial.
Żid bil- mod is- soluzzjoni ta 'ORENCIA rikostitwita minn kull kunjett għal ġol- borża ta' infużjoni jew flixkun permezz ta 'l- istess siringa li tintrema wara l- użu bla silikon ipprovduta ma' kull kunjett.
Gently mix.
Ħallat bil- mod.
The concentration of the fully diluted ORENCIA solution in the infusion bag or bottle will be approximately 5, 7.5, or 10 mg of abatacept per ml of solution depending on whether 2, 3, or 4 vials of abatacept are used.
Il- konċentrazzjoni tas- soluzzjoni ta 'ORENCIA dilwita għal kollox fil - borża ta' infużjoni jew flixkun sejra tkun bejn wieħed u ieħor 5, 7. 5, jew 10 mg ta 'abatacept għal kullml ta' soluzzjoni jiddependi fuq jekk jintużawx 2, 3 jew 4 kunjetti ta 'abatacept.
Administration: when reconstitution and dilution are performed under aseptic conditions ORENCIA infusion solution can be used immediately or within 24 hours if stored refrigerated at 2°C to 8°C.
Għoti: meta r- rikostituzzjoni u d- dilwizzjoni jsiru taħt kundizzjonijiet asettiċi, ORENCIA soluzzjoni għall- infużjoni tista 'tintuża minnufih jew fi żmien 24 siegħa jekk maħżuna fi friġġ f' temperatura ta' bejn 2°C u 8°C.
However, for microbiological reasons, it is to be used immediately.
Madankollu, għal raġunijiet mikrobijoloġiċi, għandha tintuża minnufih.
Prior to administration, the ORENCIA solution should be inspected visually for particulate matter and discolouration.
Qabel l- għoti, is- soluzzjoni ORENCIA għandha tiġi spezzjonata viżwalment għal frak jew telf fil- kulur.
Discard the solution if any particulate matter or discolouration is observed.
Armi s - soluzzjoni jekk jiġu osservati xi frak jew telf fil- kulur.
The entire, fully diluted ORENCIA solution should be administered over a period of 30 minutes and must be administered with an infusion set and a sterile, non-pyrogenic, low-protein-binding filter (pore size of 0.2 to 1.2 μm).
Is- soluzzjoni kollha ta ’ ORENCIA, dilwita għal kollox għandha tingħata fuq perjodu ta '30 minuta u għandha tingħata b' sett ta' l- infużjoni u filtru b' livell baxx ta 'tagħqid tal- proteini, mhux piroġeniku u sterili (daqs tal- pora ta' 0. 2 sa 1. 2 μm).
Do not store any unused portion of the infusion solution for reuse.
Ma għandek taħżen ebda parti tas- soluzzjoni għall - infużjoni għal użu mill- ġdid.
Other medicines:
Mediċini oħra:
ORENCIA should not be mixed with other medicines or infused concomitantly in the same intravenous line with other medicines.
ORENCIA m’ għandux jitħallat ma 'mediċini oħrajn jew jittieħed b' infużjoni fl- istess ħin fl- istess linja intravenuża ma' mediċini oħra.
No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of ORENCIA with other agents.
Ma saru ebda studji tal- kompatibilità fiżika jew bijokimika sabiex tiġi evalwata l- ko- amministrazzjoni ta 'ORENCIA ma' sustanzi oħra.
EU number
Numru tal- proċedura ta ’ l- EMEA Numru ta ’ l- EU
Package size
Kontenut (konċentrazzjoni) Daqs tal- pakkett
Hard capsule Hard capsule Hard capsule
Kapsula iebsa Kapsula iebsa Kapsula iebsa
Bottle (HDPE) Bottle (HDPE) Bottle (HDPE)
Flixkun tal- polyethylene b’ densità għolja Flixkun tal- polyethylene b’ densità għolja Flixkun tal- polyethylene b’ densità għolja
60 Capsules 60 Capsules 60 Capsules
60 kapsula 60 kapsula 60 kapsula
Orfadin 2 mg hard capsules.
Orfadin 2 mg kapsuli iebsin.
Each capsule contains 2 mg nitisinone.
Kull kapsula fiha 2 mg ta ’ nitisinone.
White, opaque capsules marked “ NTBC 2mg” on one side of the capsule.
Kapsuli bojod, opaki, immarkati b ’ “ NTBC 2mg ” fuq naħa waħda tal- kapsula.
Treatment of patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.
Kura ta ’ pazjenti b’ dijanjosi kkonfermata ta ’ tirosinemia ereditarja ta ’ tip 1 (HT- 1) flimkien ma ’ restrizzjoni tad- dieta ta ’ tyrosine u phenylalanine.
Nitisinone treatment should be initiated and supervised by a physician experienced in the treatment of HT-1 patients.
It- terapija b’ nitisinone trid tinbeda u tiġi mmaniġġjata minn tabib li għandu esperjenza fil- kura ta ’ pazjenti bl- HT- 1.
Treatment of all genotypes of the disease should be initiated as early as possible to increase overall survival and avoid complications such as liver failure, liver cancer and renal disease.
Il- kura tal- ġenotipi kollha tal- marda għandhom jinbdew kmieni kemm jista ’ jkun biex iżidu s- sopravivenza totali u jevitaw komplikazzjonijiet bħal insufffiċjenza tal- fwied, kanċer tal - fwied u mard renali.
Adjunct to the nitisinone treatment, a diet deficient in phenylalanine and tyrosine is required and should be followed by monitoring of plasma amino acids (see sections 4.4 and 4.8).
Kura aġġuntiva għall- kura b’ nitisinone, dieta li hi defiċjenti f’ phenylalanine u tyrosine hi meħtieġa u għandha tiġi segwita minn monitoraġġ ta ’ l- amino acids tal- plażma (ara sezzjonijiet 4. 4 u 4. 8).
The dose of nitisinone should be adjusted individually.
Id- doża ta ’ nitisinone għandha tkun aġġustata individwalment.
The recommended initial dose is 1 mg/ kg body weight/ day divided in 2 doses administered orally.
Id- doża tal- bidu rakkomandata hi ta ’ 1 mg/ kg ta ’ piż tal- ġisem / kuljum maqsuma f’ 2 dożi li jingħataw mill- ħalq.
The capsule may be opened and the content suspended in a small amount of water or formula diet immediately before intake.
Il- kapsula tista ’ tinfetaħ u l- kontenut jitħallat ma ’ ammont żgħir ta ’ ilma jew dieta tal - formula immedjatament qabel tittieħed.
Dose adjustment During regular monitoring, it is appropriate to follow urine succinylacetone, liver function test values and alpha-fetoprotein levels (see section 4.4).
Aġġustament tad- doża Matul il- monitoraġġ regolari, ikun xieraq li tiċċekkja l- livelli ta ’ succinylacetone fl- awrina, il- valuri tat- test tal- funzjoni tal- fwied u l- livelli ta ’ alpha- fetoprotein (ara sezzjoni 4. 4).
If urine succinylacetone is still detectable one month after the start of nitisinone treatment, the nitisinone dose should be increased to 1.5 mg/ kg body weight/ day divided in 2 doses.
Jekk succinylacetone fl - awrina jkun jista ’ jiġi osservat wara xahar mill- bidu tal- kura b’ nitisinone, id- doża ta ’ nitisinone għandha tiżdied għal 1. 5 mg/ kg ta ’ piż tal- ġisem / kuljum, maqsuma f’ 2 dożi.
A dose of 2 mg/ kg body weight/ day may be needed based on the evaluation of all biochemical parameters.
Doża ta ’ 2 mg għal kull kilogramm ta ’ piż tal- ġisem kuljum tista ’ tkun meħtieġa bbażata fuq l- evalwazzjoni tal- parametri bijokimiċi kollha.
This dose should be considered as a maximal dose for all patients.
Din id- doża għandha tkun ikkunsidrata bħala d- doża massima għall- pazjenti kollha.
If the biochemical response is satisfactory, the dose should be adjusted only according to body weight gain.
Jekk ir- rispons bijokimiku jkun sodisfaċenti, id- doża għandha tiġi aġġustata biss skond iż- żieda tal- piż tal- ġisem.
However, in addition to the tests above, during the initiation of therapy or if there is a deterioration, it may be necessary to follow more closely all available biochemical parameters (i. e. plasma succinylacetone, urine 5-aminolevulinate (ALA) and erythrocyte porphobilinogen (PBG)-synthase activity).
Madankollu, flimkien mat- testijiet t’ hawn fuq, matul il- bidu tat- terapija jew jekk ikun hemm deterjorament, jista ’ jkun meħtieġ li ssegwi iktar mill- qrib il- parametri bijokimiċi kollha disponibbli (i. e. succinylacetone fil- plażma, 5- aminolevulinate (ALA) fl- awrina u l- attività ta ’ erythrocyte porphobilinogen (PBG) - synthase).
2 Mothers receiving nitisinone should not breast-feed (see sections 4.6 and 5.3).
Ommijiet li jkunu qed jużaw nitisinone m’ għandhomx ireddgħu (ara sezzjonijiet 4. 6 u 5. 3).
Dietary restriction in relation to visual disorders It is recommended that a slit-lamp examination of the eyes is performed before initiation of nitisinone treatment.
Hu rakkomandat li jsir eżami slit- lamp ta ’ l- għajnejn qabel il- bidu tal- kura b’ nitisinone.
A patient displaying visual disorders during treatment with nitisinone should without delay be examined by an ophthalmologist.
Pazjent li jkollu disturbi tal- vista matul il- kura b’ nitisinone għandu jiġi eżaminat minn oftalmologu mingħajr telf ta ’ żmien.
It should be established that the patient is adhering to his dietary regimen and the plasma tyrosine concentration should be measured.
Għandu jiġi stabbilit jekk il- pazjent hux qed isegwi l- kors tad- dieta, u għandha titkejjel il - konċentrazzjoni ta ’ tyrosine fil- plażma.
A more restricted tyrosine and phenylalanine diet should be implemented in case the plasma tyrosine level is above 500 micromol/ l.
Dieta iktar ristretta ta ’ tyrosine u phenylalanine għandha tiġi implimentata fil- każ li l- livell ta ’ tyrosine fil- plażma jkun iktar minn 500 micromol/ l.
It is not recommended to lower the plasma tyrosine concentration by reduction or discontinuation of nitisinone, since the metabolic defect may result in deterioration of the patient’ s clinical condition.
Mhux rakkomandat li tbaxxi l- konċentrazzjoni ta ’ tyrosine fil- plażma bit- tnaqqis jew bit- twaqqif ta ’ nitisinone, għax id- difett metaboliku jista ’ jirriżulta f’ deterjorament tal- kundizzjoni klinika tal- pazjent.
Liver monitoring The liver function should be monitored regularly by liver function tests and liver imaging.
Monitoraġġ tal- fwied Il- funzjoni tal- fwied għandha tiġi mmonitorjata regolarment permezz ta ’ testijiet tal- funzjoni tal- fwied u bl- immaġni tal- fwied.
It is recommended also to monitor serum alpha-fetoprotein concentration.
Hu rakkomandat ukoll li jsir monitoraġġ tal- konċentrazzjoni ta ’ alpha - fetoprotein fis- serum.
Increase in serum alpha- fetoprotein concentration may be a sign of inadequate treatment.
Iż- żieda fil- konċentrazzjoni ta ’ alpha- fetoprotein fis- serum tista ’ tkun sinjal ta ’ kura inadegwata.
Patients with increasing alpha- fetoprotein or signs of nodules in the liver should always be evaluated for hepatic malignancy.
Pazjenti li jkollhom alpha- fetoprotein li tkun qed tiżdied jew sinjali ta ’ għoqod fil - fwied għandhom dejjem ikunu evalwati għal malinni tal- fwied.
Platelet and white blood cell (WBC) monitoring It is recommended that platelet and white cell counts are monitored regularly, as a few cases of reversible trombocytopenia and leucopenia were observed during clinical evaluation.
Monitoraġġ tal- plejtlits u taċ- ċelluli bojod tad- demm (white blood cell - WBC) Hu rakkomandat li l- għadd tal- plejtlets plejtlits u taċ- ċelluli bojod tad- demm ikun immonitorjat regolarment, minħabba li xi ftit każijiet ta ’ tromboċitopenja u lewkopenja riversibbli kienu osservati matul l- evalwazzjoni klinika.
Monitoring visits should be performed every 6 months; shorter intervals between visits are recommended in case of adverse events.
Viżti ta ’ monitoraġġ għandhom jitwettqu kull 6 xhur; intervalli iqsar bejn il- viżti huma rakkomandati f’ każ ta ’ avvenimenti avversi.
No formal interaction studies with other medicinal products have been conducted.
Ma sarux studji formali dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal - prodott.
Nitisinone is metabolised in vitro by CYP 3A4 and dose-adjustment may therefore be needed when nitisinone is co-administered with inhibitors or inducers of this enzyme.
Nitisinone hu metabolat in vitro minn CYP 3A4 u jista ’ jkun hemm bżonn ta ’ aġġustament tad- doża meta nitisinone jingħata flimkien ma ’ inibituri jew inducers ta ’ din l- enzima.
Based on in vitro studies, nitisinone is not expected to inhibit CYP 1A2, 2C9, 2C19, 2D6, 2E1 or 3A4- mediated metabolism.
Ibbażat fuq studji in vitro, nitisinone mhux mistenni li jinibixxi metaboliżmu medjat ta ’ CYP 1A2, 2C9, 2C19, 2D6, 2E1 jew 3A4.
No formal food interactions studies have been performed.
Ma sarux studji formali dwar l- effett ta ’ l- ikel fuq l- effett farmaċewtiku tal- prodott.
However, nitisinone has been co- administered with food during the generation of efficacy and safety data.
Madankollu, nitisinone ingħata flimkien ma ’ l- ikel matul produzzjoni ta ’ dejta fuq l- effikaċja u s- sigurtà.
Therefore, it is recommended that if nitisinone treatment is initiated with food, this should be maintained on a routine basis.
Għalhekk, hu rakkomandat li jekk il- kura b’ nitisinone tinbeda ma ’ l- ikel, din għandha titkompla fuq bażi regolari.
Pregnancy There are no adequate data from the use of nitisinone in pregnant women.
Tqala M’ hemmx informazzjoni adegwata mill- użu ta ’ nitisinone f’ nisa tqal.
Nitisinone should not be used during pregnancy unless clearly necessary.
Nitisinone m’ għandux jintuża waqt it- tqala jekk m’ hemmx bżonn ċar.
Lactation It is not known whether nitisinone is excreted in human breast milk.
Treddigħ Mhuwiex magħruf jekk nitisinone jitneħħiex fil- ħalib tas- sider uman.
Animal studies have shown adverse postnatal effects via exposure of nitisinone in milk.
Għalhekk, ommijiet li
Therefore, mothers receiving nitisinone should not breast-feed, since a risk to the suckling child cannot be excluded (see sections 4.3 and 5.3).
3 jkunu qed jieħdu nitisinone m’ għandhomx ireddgħu, għax ir- riskju lit- tarbija li tkun qed terda ’ ma jistax jiġi eskluż (ara sezzjonijiet 4. 3 u 5. 3).
3 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
The adverse reactions considered at least possibly related to treatment are listed below, by body system organ class, and absolute frequency.
Ir- reazzjonijiet avversi kkunsidrati li kienu mill- inqas possibbilment relatati mal- kura huma elenkati hawn taħt skond il- klassi ta ’ l- organi tas- sistema tal- ġisem u skond il- frekwenza assoluta.