qanastek/EMEA-V3 huggingface dataset:
In cynomolgus monkeys treated with natalizumab until parturition, low levels of natalizumab were detected in the breast milk of some animals, indicating the possibility for transfer of natalizumab into breast milk in humans (see section 4.6).
F’ xadini cynomolgus kkurati b’ natalizumab sat- twelid, livelli baxxi ta ’ natalizumab instabu fil- ħalib tas- sider ta ’ xi annimali, u b’ hekk jissuġġerixxi li hemm il- possibilità li natalizumab jgħaddi fil- ħalib tas- sider fil- bnedmin (ara sezzjoni 4. 6).
Sodium phosphate, monobasic, monohydrate Sodium phosphate, dibasic, heptahydrate Sodium chloride Polysorbate 80 (E433) Water for Injections.
Sodium phosphate, monobasic, monohydrate Sodium phosphate, dibasic, heptahydrate Sodium chloride Polysorbate 80 (E433) Ilma għall- injezzjonijiet.
TYSABRI must not be mixed with other medicinal products except those mentioned in section 6.6.
TYSABRI m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn ħlief dawk imsemmija f’ sezzjoni 6. 6.
Concentrate
Konċentrat
4 years
Erba ’ snin
Diluted solution
Soluzzjoni dilwita
After dilution, immediate use is recommended.
Wara d- dilwazzjoni, huwa rrakkomandat użu mmedjat.
If not used immediately, the diluted solution must be stored at 2˚ C - 8˚ C and infused within 8 hours of dilution.
Jekk ma jintużax immedjatament, is- soluzzjoni dilwita għandha tinħażen f’ temperatura ta ’ 2˚C - 8˚C u infuża sa 8 sigħat wara d- dilwazzjoni.
In-use storage times and conditions prior to use are the responsibility of the user.
It- tul u l - kundizzjonijiet ta ’ ħażna waqt l- użu huma r- responsabbiltà ta ’ min qed jużah.
Store in a refrigerator (2 ˚ C - 8˚ C).
Aħżen fi friġġ (2˚C - 8˚C).
For storage conditions of the diluted medicinal product see section 6.3.
12 Għall- kundizzjonijiet ta ’ ħażna tal- prodott mediċinali dilwit, ara sezzjoni 6. 3.
15 ml TYSABRI in a vial (type I glass) with a stopper (bromobutyl rubber) and a seal (aluminium) with a flip-off cap.
15 ml ta ’ TYSABRI f’ kunjett (ħġieġ tat- tip I) b’ tapp (lasktu bromobutyl) u siġill (aluminju) b’ għatu flip- off.
Pack size of one vial per carton.
Daqs tal- pakkett huwa kunjett wieħed f’ kull kartuna.
Instructions for use:
Istruzzjonijiet għall- użu:
Inspect the TYSABRI vial for particles prior to dilution and administration.
Spezzjona il- kunjett ta ’ TYSABRI għall- frak qabel id- dilwazzjoni u l- għotja.
If particles are observed and/ or the liquid in the vial is not colourless, clear to slightly opalescent, the vial must not be used.
Jekk jiġu osservati l- frak u/ jew il- likwidu fil- kunjett mhux bla kulur, ċar għal kemmxejn ikanġi, l- kunjett m’ għandux jintuża.
Use aseptic technique when preparing TYSABRI solution for intravenous (IV) infusion.
Uża teknika asettika meta tipprepara soluzzjoni ta ’ TYSABRI għall- infużjoni ġol- vini (IV).
Remove flip-off cap from the vial.
Neħħi l- għatu flip- off mill- kunjett.
Insert the syringe needle into the vial through the centre of the rubber stopper and remove 15 ml concentrate for solution for infusion.
Daħħal il- labra tas- siringa ġewwa l- kunjett minn ġewwa ċ - ċentru tat- tapp tal- lasktu u iġbed 15 ml ta ’ konċentrat għal soluzzjoni għall- infużjoni.
Add the 15 ml concentrate for solution for infusion to 100 ml sodium chloride 9 mg/ ml (0.9%) solution for injection.
Żid il- 15 ml ta ’ konċentrat għal soluzzjoni għall- infużjoni ma ’ 100 ml ta ’ soluzzjoni għall - injezzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%).
Gently invert the TYSABRI solution to mix completely.
Aqleb bil- mod ta ’ taħt fuq is- soluzzjoni TYSABRI biex tħallat kollox.
TYSABRI must not be mixed with other medicinal products or diluents.
TYSABRI m’ għandux jitħallat ma ’ prodotti mediċinali jew dilwenti oħra.
5 Visually inspect the diluted product for particles or discolouration prior to administration.
5 Spezzjona il- prodott dilwit għall- frak jew tibdil fil- kulur qabel l- għotja.
Do not use if it is discoloured or if foreign particles are seen.
Tużax jekk tkun bidlet il- kulur jew jekk tara xi frak.
The diluted product is to be used as soon as possible and within 8 hours of dilution.
Il- prodott dilwit għandu jintuża mill- aktar fis possibbli u sa 8 sigħat mid- dilwizzjoni.
If the diluted product is stored at 2˚ C - 8˚ C (do not freeze), allow the solution to warm to room temperature prior to infusion.
Jekk il - prodott dilwit huwa maħżun f’ 2˚C - 8˚C (tiffriżax), ħalli is- soluzzjoni tilħaq it- temperatura tal - kamra qabel l- infużjoni.
The diluted solution is to be infused intravenously over 1 hour at a rate of approximately 2 ml/ minute.
Is- soluzzjoni dilwita għandha tiġi infuża ġol- vini fuq perijodu ta ’ siegħa b’ rata ta ’ madwar 2 ml/ minuta.
After the infusion is complete, flush the intravenous line with sodium chloride 9 mg/ ml (0.9%) solution for injection.
Wara li tintemm l- infużjoni, laħlaħ il- pajp sejjer għal ġol- vina b’ soluzzjoni għall- injezzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%).
Each vial is for single– use only.
Kull kunjett huwa għall- użu ta ’ darba biss.
Any unused product or waste material must be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Elan Pharma International Ltd., Monksland, Athlone, County Westmeath, Ireland
Elan Pharma International Ltd., Monksland, Athlone, County Westmeath, L- Irlanda
27th June 2006
27 ta ’ Ġunju 2006 13 10.
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 Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
14 A.
14 ANNESS II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
Robijnlaan 8 NL-2132 Hoofddorp The Netherlands
Robijnlaan 8 NL- 2132 Hoofddorp L- Olanda
Biogen Idec Denmark Manufacturing ApS Biogen Idec Allé 1 DK-3400 Hillerød Denmark
Biogen Idec Denmark Manufacturing ApS Biogen Idec Allé 1 DK- 3400 Hillerød Id- Danimarka
The Marketing Authorisation Holder must implement nationally, prior to marketing, and as agreed with the competent authorities in the Member States that all physicians who intend to prescribe TYSABRI are provided with a physician pack containing the following elements: • Product information • Physician information about TYSABRI • Patient alert card.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jimplimenta nazzjonalment, qabel it - tqegħid fis- suq, u kif miftiehem ma ’ l- awtoritajiet kompetenti fl- Istati Membri li t- tobba kollha li jaħsbu li se jiktbu TYSABRI jiġu pprovduti b’ pakk għat- tobba li fiħ l- affarijiet li ġejjin: • Informazzjoni dwar il- prodott • Informazzjoni għat- tobba dwar TYSABRI • Kartuna ta ’ Allarm tal- pazjent
The physician information about TYSABRI shall contain the following key elements: • Restricted indication • Atypical/ opportunistic infections in particular PML including:
L- informazzjoni għat- tobba dwar TYSABRI irid ikollha dawn l- elementi prinċipali li ġejjin: • Indikazzjoni ristretta • Infezzjonijiet atipiċi/ opportunistiċi speċjalment PML, inkluż:
Diagnosis of PML including differentiation between PML and MS relapse PML management algorithm Possibility of other opportunistic infections
Dijanjożi ta ’ PML, inkluż id- divrenzjar bejn PML u episodju ta ’ rkadar ta ’ MS Sett ta ’ regoli għall- immaniġġjar ta ’ PML Possibilità ta ’ infezzjonijiet opportunistiċi oħra
• Infusion reactions • Hypersensitivity reactions • Antibody formation
• Reazzjonijiet tal- infużjoni • Reazzjonijiet ta ’ sensittività eċċessiva • Formazzjoni ta ’ antikorpi
15 • Need to inform patients about the benefits and risk of TYSABRI and provide them with a patient alert card.
16 • Bżonn li tinforma il- pazjienti dwar il- benfiċċji u r- riskji ta ’ TYSABRI u tipprovdilhom kartuna ta ’ allarm tal- pazjent.
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
Id- Detentur ta ’ l- Awtorizazzjoni għat- tqegħid fis- Suq irid jassigura li s- sistema ta ’ farmakoviġilanza hija f’ postha u li qed taħdem qabel ma l- prodott jitpoġġa fis- suq u sakemm il- prodott li tpoġġa fis- suq baqa ’ jintuża.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Id- Detentur ta ’ l- Awtorizazzjoni għat- tqegħid fis- Suq jikkommetti ruħu li jwettaq l- istudji u l - attivitajiet miżjuda ta ’ Farmakoviġilanza kif iddettaljat fil- Pjan ta ’ Farmakoviġilanza.
An updated Risk Management Plan should be provided as per the CHMP Guideline on Risk Management Systems for medicinal products for human use.
Pjan ta ’ Mmaniġġjar ta ’ Riskji mġedded għandu jiġi pprovdut skond il- Linji Gwida ta ’ CHMP dwar is- Sistemi ta ’ Mmaniġġjar ta ’ Riskji għall- prodotti mediċinali għall- użu fil- bniedem.
The MAH will submit PSURs on 6 monthly basis until otherwise specified.
Id- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- Suq se jissottometti PSURs kull 6 xhur sakemm speċifikat mod ieħor.
TYSABRI 300 mg concentrate for solution for infusion natalizumab
TYSABRI 300 mg konċentrat għal soluzzjoni għall- infużjoni natalizumab
Each 15 ml vial of concentrate contains 300 mg natalizumab (20 mg/ ml);
Kull kunjett ta ’ 15 ml ta ’ konċentrat fih 300 mg natalizumab (20 mg/ ml);
sodium phosphate, monobasic, monohydrate; sodium phosphate, dibasic, heptahydrate; sodium chloride; polysorbate 80 (E433) and water for injections.
sodium phosphate, monobasic, monohydrate; sodium phosphate, dibasic, heptahydrate; sodium chloride; polysorbate 80 (E433) u ilma għall- injezzjoni.
1 x 15 ml vial
Kunjett 1 x 15 ml
Dilute before infusion.
Iddilwixxi qabel l- infużjoni.
Monksland Athlone County Westmeath Ireland
Monksland Athlone County Westmeath L- Irlanda
In addition to this leaflet you will be given a Patient Alert Card, which contains important safety information that you need to know before you are given TYSABRI (pronounced tie-SA-bree) and during treatment with TYSABRI.
Minbarra dan il- fuljett inti se tingħata Kartuna ta ’ Allarm tal- Pazjent, li fiha informazzjoni importanti dwar is- sigurtà li inti teħtieġ li tkun taf qabel tingħata TYSABRI (ippronunċjat tie- SA- bree) u waqt kura b’ TYSABRI.
- Keep this leaflet and the Patient Alert Card.
- Żomm dan il- fuljett u l- Kartuna ta ’ Allarm tal- Pazjent.
- It is important that you keep the Alert Card with you during treatment and for six months after
- Huwa mportanti li żżomm il- Kartuna ta ’ Allarm miegħek waqt il- kura u għal sitt xhur wara l -
the last dose of TYSABRI, since side effects may occur even after you have stopped treatment.
aħħar doża ta ’ TYSABRI, minħabba li effetti sekondarji jistgħu jseħħu anke wara li twaqqaf il - kura.
If you
- Dan il- fuljett se jispjega dwar l- effetti sekondarji li uħud mill- pazjenti jkollhom b ’ TYSABRI.
have any worrying side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
Jekk għandek xi effetti sekondarji li qed jinkwetawk, jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What TYSABRI is and what it is used for 2.
X’ inhu TYSABRI u għalxiex jintuża 2.
Before you use TYSABRI 3.
Qabel ma tuża TYSABRI 3.
How to use TYSABRI 4.
Kif għandek tuża TYSABRI 4.
How to store TYSABRI 6.
Kif taħżen TYSABRI 6.
WHAT TYSABRI IS AND WHAT IT IS USED FOR
X’ INHU TYSABRI U GĦALXIEX JINTUŻA
TYSABRI is used to treat multiple sclerosis (MS).
TYSABRI jintuża biex jikkura l- isklerożi multipla (MS).
The symptoms of MS vary from patient to patient, and you may experience some or none of them.
Is- sintomi ta ’ MS jvarjaw minn pażjent għal pazjent, u int tista ’ tesperjenza uħud jew l- ebda minnhom.
Symptoms can include; walking problems, numbness in the face, arms or legs, problems seeing things, tiredness, feeling off-balance or light headed, bladder and bowel problems, difficulty in thinking and concentrating, depression, acute or chronic pain, sexual problems, and stiffness and muscle spasms.
Is- Sintomi jistgħu jinkludu; problemi biex timxi, tnemnim fil- wiċċ, idejn jew saqajn, problemi biex tara, għejja, tħossok titlef il- bilanċ jew sturdut, problemi tal- bużżieqa tal- awrina u tal- musrana, diffikultà biex taħseb u tikkonċentra, depressjoni, uġigħ akut jew kroniku, problemi sesswali, u egħbusija u spażmi fil- muskoli.
When the symptoms flare up, it is called a relapse (also known as an exacerbation or an attack).
Meta s- sintomi jiżdiedu, din tissejjaħ rikaduta (magħrufa wkoll bħala taħrix tal- marda jew attakk).
When a relapse occurs, you may notice the symptoms suddenly, within a few hours, or slowly progressing over several days.
Meta sseħħ rikaduta, tista ’ tinnota s- sintomi f’ daqqa waħda, f’ temp ta ’ ftit siegħat, jew progressjoni bil- mod fuq medda ta ’ bosta ġranet.
Your symptoms will then usually improve gradually (this is called a remission).
Wara s- sintomi tiegħek ġeneralment jitjiebu bil- mod (dan jissejjaħ remissjoni).
MS causes inflammation in the brain that damages the nerve cells.
MS tikkawża infjammazzjoni fil- moħħ li tagħmel ħsara liċ- ċelluli tan- nervaturi.
In TYSABRI the active ingredient is natalizumab, a protein similar to your own antibodies.
F’ TYSABRI is - sustanza attiva hija natalizumab, proteina simili għall- antikorpi tiegħek stess.
It stops the cells that cause inflammation from going into your brain.
Hija twaqqaf iċ- ċelluli li jikkawżaw l- infjammazzjoni milli jmorru ġo moħħok.
This reduces nerve damage caused by MS.
Dan inaqqas il- ħsara lin- nervaturi kkawżata minn MS.
In clinical trials, TYSABRI approximately halved the progression of the disabling effects of MS and also decreased the number of MS attacks by about two-thirds.
Fi provi kliniċi, TYSABRI naqqas b’ madwar in- nofs il- progress tal- effetti li jikkawżaw id- diżabilità ta ’ MS u naqqas ukoll in- numru ta ’ attakki ta ’ MS b’ madwar żewġ- terżi.
However, TYSABRI cannot repair the damage that has already been caused by MS.
Iżda, TYSABRI ma jistax isewwi l- ħsara li diġà saret minn MS.
When you receive TYSABRI you might not notice any improvement, but TYSABRI may still be working to prevent your MS becoming worse.
Meta tirċievi TYSABRI tista ’ ma tinnota l- ebda titjib, iżda TYSABRI jista ’ jkun għadu qed jaħdem biex jipprevjeni l- MS tiegħek milli tmur għall- agħar.
It is important to continue with your medicine for as long as you and your doctor decide that it is helping you.
Huwa mportanti li tkompli bil- mediċina tiegħek sakemm int u t- tabib tiegħek tiddeċiedu li qed tgħinek.
BEFORE YOU USE TYSABRI
QABEL MA TUŻA TYSABRI
Before you start treatment with TYSABRI, it is important that you and your doctor have discussed the benefits you would expect to receive from this treatment and the risks that are associated with it.
24 Qabel ma tibda l- kura b’ TYSABRI, huwa mportanti li int u t- tabib tiegħek tkunu ddiskutejtu l - benefiċċji li int tistenna li tieħu minn din il- kura u r- riskji li huma assoċjati magħha.
Do not use TYSABRI • If you are allergic (hypersensitive) to natalizumab or any of the other ingredients of TYSABRI (see section 6 for the ingredients).
Tużax TYSABRI • Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal natalizumab jew sustanzi oħra ta ’ TYSABRI (ara sezzjoni 6 għas- sustanzi).
• If your doctor has told you that you have PML (progressive multifocal leukoencephalopathy).
• Jekk it- tabib tiegħek qallek li għandek PML (lewkoenċefalopatija multifokali progressiva).
PML is a rare infection of the brain.
PML hija infezzjoni rari tal- moħħ.
• If your doctor tells you that you have a serious problem with your immune system (due to disease for example, leukaemia or HIV or due to a medicine you are taking or have previously taken).
• Jekk it- tabib tiegħek jgħidlek li għandek problema serja bis- sistema immuni tiegħek (minħabba mard per eżempju, lewkimja jew HIV jew minħabba mediċina li qed tieħu jew li ħadt qabel).
• If you are taking medicines that cannot be used with TYSABRI (see Using other medicines, below).
• Jekk qed tieħu mediċini li ma jistgħux jintużaw ma ’ TYSABRI (ara Meta tuża mediċini oħra, taħt).
• If you have cancer (unless it is a type of skin cancer called basal cell carcinoma).
• Jekk għandek kanċer (sakemm mhux tip ta ’ kanċer tal- ġilda msejjaħ karċinoma taċ- ċelluli bażali).
• If you are under 18 years of age.
• Jekk inti għandek eta ’ taħt 18- il sena.
Take special care with TYSABRI There have been reports of a rare brain infection called PML (progressive multifocal leukoencephalopathy) that have occurred in patients who have been given TYSABRI.
Oqgħod attent ħafna b’ TYSABRI Kien hemm rapporti ta ’ infezzjoni rari tal- moħħ imsejjħa PML (lewkoenċefalopatija multifokali progressiva) li seħħew f’ pazjenti li ngħataw TYSABRI.
PML usually leads to severe disability or death.
PML ħafna drabi twassal għall- diżabilità severa jew mewt.
The symptoms of PML may be similar to an MS relapse (e. g. weakness or visual changes).
Is- sintomi ta ’ PML jistgħu jkunu simili għal rikaduta ta ’ MS (e. ż. debbulizza jew bidliet fil- vista).
Therefore, if you believe your MS is getting worse or if you notice any new symptoms, it is very important that you speak to your doctor as soon as possible.
Għalhekk, jekk taħseb li l- MS tiegħek sejra għall- agħar jew jekk tinnota xi sintomi ġodda, huwa mportanti ħafna li tkellem lit- tabib tiegħek mill- aktar fis possibbli.
Speak with your partner or caregivers and inform them about your treatment.
Kellem lis- sieħeb/ sieħba tiegħek jew lin- nies li qed jieħdu ħsiebek u nfurmhom dwar il- kura tiegħek.
Symptoms might arise that you might not become aware of by yourself, such as changes in mood or behaviour, memory lapses, speech and communication difficulties, which your doctor may need to investigate further to rule out PML.
Jista ’ jkun hemm sintomi li inti ma tindunax bihom waħdek, bħal bidliet fil- burdata jew fl- imġieba, telf tal- memorja, diffikultajiet fil- kliem u l- komunikazzjoni, li t- tabib tiegħek għandu mnejn ikollu bżonn jinvestiga aktar biex jelimina PML.
You will also find this information in the Patient Alert Card you have been given by your doctor.
Issib din l- informazzjoni wkoll fil- Kartuna ta ’ Allarm tal- Pazjent li ngħatatlek mit- tabib tiegħek.
It is important that you keep this Alert Card and show it to your partner or caregivers.
Huwa mportanti li inti żżomm din il- Kartuna ta ’ Allarm u turiha lis- sieħeb/ a tiegħek jew lill- persuni li qed jieħdu ħsiebek.
Serious infections may occur with TYSABRI.
Jista ’ jkun hemm infezzjonijiet serji b’ TYSABRI.
If you develop any infection, or if you develop symptoms like an unexplained fever, severe diarrhoea, prolonged dizziness / headache / stiff neck, weight loss, or listlessness, or other symptoms potentially associated with an infection whilst receiving TYSABRI, speak to your doctor as soon as possible and show the Patient Alert Card and this package leaflet to him.
Jekk tiżviluppa xi infezzjoni, jew jekk tiżviluppa xi sintomi bħal deni bla spjegazzjoni, dijarea qawwija, sturdament / uġigħ ta ’ ras / egħbusija fl- għonq li jdum, telf fil- piż, jew nuqqas ta ’ enerġija, jew sintomi oħra potenzjalment assoċjati ma ’ infezzjoni waqt li qed tirċievi TYSABRI, kellem lit- tabib tiegħek mill- aktar fis possibbli u urih l- Kartuna ta ’ Allarm tal- Pazjent u dan il- fuljet ta ’ tagħrif.
It is important that you keep this Alert Card.
Huwa mportanti li inti żżomm din il- Kartuna ta ’ Allarm.
Using other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines you may have obtained without a prescription.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
You may not be able to use TYSABRI with some medicines that affect your immune system.
Jista ’ jagħti l- każ li ma tkunx tista ’ tuża TYSABRI ma ’ ċertu mediċini li jaffettwaw is- sistema immuni tiegħek.
24 Pregnancy and breast-feeding You should not use TYSABRI if you are pregnant unless you have discussed this with your doctor.
25 M’ għandekx tuża TYSABRI jekk inti tqila sakemm ma tkunx iddiskutejt dan mat- tabib tiegħek.
Be sure to tell your doctor immediately if you are pregnant, think you may be pregnant, or if you are planning to become pregnant.
Kun ċerta li tgħid lit- tabib tiegħek minnufih jekk inti tqila, jew taħseb li inti tqila jew jekk qed tippjana li toħroġ tqila.
Do not breast-feed whilst using TYSABRI.
Treddgħax waqt li qed tuża TYSABRI.
You should discuss with your doctor whether you choose to breast-feed or to use TYSABRI.
Għandek tiddikuti mat- tabib tiegħek jekk tagħżilx li tredda ’ jew li tuża TYSABRI.
Ask your doctor or pharmacist for advice before taking any other medicine with TYSABRI.
Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu mediċini oħra ma ’ TYSABRI.
Driving and using machines TYSABRI is not expected to have an effect on your ability to drive or to operate machines.
Sewqan u tħaddim ta ’ magni TYSABRI mhux mistenni li jkollu effett fuq il- ħila tiegħek li ssuq jew li tħaddem magni.
If you are concerned, discuss this with your doctor.
Jekk għandek xi dubji, iddiskutihom mat- tabib tiegħek.
HOW TO USE TYSABRI
KIF GĦANDEK TUŻA TYSABRI
TYSABRI will be prepared and given to you by a doctor.
TYSABRI se jiġi ppreparat u mogħti lilek mit- tabib.
Information for medical or healthcare professionals on how to prepare and administer TYSABRI is provided at the end of this leaflet.
Informazzjoni għat- tobba u professjonisti tas- saħħa dwar kif tipprepara u tagħti TYSABRI hija pprovduta fl- aħħar ta ’ dan il- fuljett.
The adult dose is 300 mg given once every 4 weeks.
Id- doża għall- adulti hija 300 mg mogħtija darba kull 4 ġimgħat.
TYSABRI must be diluted before it is given to you.
TYSABRI għandu jiġi dilwit qabel ma jingħatalek.
It is given as a drip into a vein (by intravenous infusion), usually in your arm.
Jingħata bħala drip ġo vina (permezz ta ’ infużjoni ġol- vini), ħafna drabi f’ idejk.
This takes about 1 hour.
Dan jieħu madwar siegħa.
A few patients have had an allergic reaction to TYSABRI.
Numru żgħir ta ’ pazjenti kellhom reazzjoni allerġika għal TYSABRI.
Your doctor will check for allergic reactions during the infusion and for 1 hour afterwards.
It- tabib tegħek jissorveljak għar - reazzjonijiet allerġiċi waqt l- infużjoni u għal siegħa wara.
Continuous dosing with TYSABRI is important, especially during the first few months of treatment.
Hu importanti id- doża kontinwa ta ’ TYSABRI, speċjalment waqt l- ewwel ftit xhur tal- kura.
This is because patients who received one or two doses of TYSABRI and then had a gap in treatment of three months or more, were more likely to have an allergic reaction when resuming treatment.
Dan hu minħabba li pazjenti li irċevew waħda jew żewġ dożi ta ’ TYSABRI u wara waqfien tal- kura għal tlett xhur jew aktar, kienu aktar probabli li jkollhom rejazzjonijiet allerġiċi meta jerġa ’ jinbeda t - trattament.
If you miss your dose of TYSABRI If you miss your usual dose of TYSABRI, arrange with your doctor to receive it as soon as you can.
Jekk tinsa tieħu TYSABRI Jekk tinsa tieħu d- doża tiegħek tas- soltu ta ’ TYSABRI, ftiehem mat- tabib tiegħek biex teħodha mill - aktar fis possibbli.
You can then continue to receive your dose of TYSABRI every 4 weeks.
Wara tista ’ tibqa tieħu d- doża tiegħek ta ’ TYSABRI kull 4 ġimgħat.
Like all medicines, TYSABRI can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, TYSABRI jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If you have any worrying side effects, including any not listed in this leaflet, please tell your doctor, nurse or pharmacist as soon as possible.
Jekk għandek xi effetti sekondarji li qed jinkwetawk, inkluż xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib, ners jew lill- ispiżjar tiegħek.
25 Speak to your doctor or nurse immediately if you notice any of the following:
Kellem lit- tabib jew ners tiegħek minnufih jekk tinnota xi wieħed minn dawn li ġejjin:
Signs of allergy to TYSABRI, during or shortly after your infusion: • Itchy rash (hives) • Swelling of your face, lips or tongue • Difficulty breathing • Chest pain or discomfort • Increase or decrease in your blood pressure (your doctor or nurse will notice this if they are monitoring your blood pressure).
Sinjali ta ’ allerġija għal TYSABRI li ġejjin waqt jew ftit wara l- infużjoni tiegħek: • Raxx bil- ħakk (ħorriqija) • Nefħa fil- wiċċ, xuftejjn jew ilsien • Diffikultà biex tieħu n- nifs
Signs of a possible liver problem: • Yellowing of your skin or the whites of your eyes • Unusual darkening of the urine.
Sinjali ta ’ problema possibbli fil- fwied: • Sfura tal- ġilda jew ta ’ l- abjad t’ għajnejk • Kulur skur mhux tas- soltu ta ’ l- awrina.
TYSABRI can also have other side effects.
TYSABRI jista ’ jkollu effetti sekondrji oħra.
Side effects are listed below by how commonly they have been reported in clinical trials:
L- effetti sekondarji huma mniżżla hawn taħt skond il- frekwenza ta ’ rappurtar fil- provi kliniċi:
Common side effects that may occur in less than 10 in 100 patients: • Urinary tract infection • Sore throat and runny or blocked up nose • Shivering • Itchy rash (hives) • Headache • Dizziness • Feeling sick (nausea) • Being sick (vomiting) • Joint pain • Fever • Tiredness.
Effetti sekondarji komuni li jistgħu jidhru f’ anqas minn 10 kull 100 pazjent: • Infezzjoni fil- passaġġ ta ’ l- awrina • Uġigħ fil- griżmejn u mnieħer iqattar jew imblukkat • Tertir • Raxx bil- ħakk (ħorriqija) • Uġigħ ta ’ ras • Sturdament • Tħossok ma tiflaħx (tqalliġh) • Tħossok mdardar (rimettar) • Uġigħ fil- ġogi • Deni • Għeja.
Uncommon side effects that may occur in less than 1 in 100 patients: • Severe allergy (hypersensitivity).
Effetti sekondarji mhux komuni li jistgħu jidhru f’ anqas minn 1 kull 100 pazjent: • Allerġija severa (sensittività eċċessiva).
Rare side effects that may occur in less than 1 in 1000 patients: • Unusual infections (so-called “ Opportunistic infections”) • Progressive multifocal leukoencephalopathy (PML), a rare brain infection.
Effetti sekondarji rari li jistgħu jseħħu f’ inqas minn 1 minn kull 1000 pazjent: • Infezzjonijiet mhux tas- soltu (hekk magħrufa “ Infezzjonijiet opportunistiċi ”) • Lewkoenċefalopatija multifokali progressiva (PML), infezzjoni rari tal- moħħ.
What to do if your MS gets worse or you notice new symptoms There have been reports of a rare brain infection called PML (progressive multifocal leukoencephalopathy) that have occurred in patients who have been given TYSABRI.
X’ tagħmel jekk l- MS tiegħek tmur għall- agħar jew jekk tinnota sintomi ġodda Kien hemm rapporti ta ’ infezzjoni rari fil- moħħ imsejjħa PML (lewkoenċefalopatija multifokali progressiva) li seħħew f’ pazjenti li ngħataw TYSABRI.
The symptoms of PML may be similar to an MS relapse. • Therefore, if you believe your MS is getting worse or if you notice any new symptoms, it is important that you speak to your doctor as soon as possible. • Discuss your treatment with your partner or caregivers.
Is- sintomi ta ’ PML jista ’ jkunu simili għall- rikaduta ta ’ MS. • Għalhekk, jekk taħseb li l- MS tiegħek sejra għall- agħar jew jekk tinnota xi sintomi ġodda, huwa mportanti li tkellem lit- tabib tiegħek minnufih. • Kellem lis- sieħeb/ sieħba tiegħek jew lin- nies li qed jieħdu ħsiebek u infurmhom dwar il- kura tiegħek.
They might see new symptoms that you might not notice such as changes in mood or behaviour, memory lapses, speech and communication difficulties, which your doctor may need to investigate further to rule out PML. • Show the Alert Card and this package leaflet to any doctor involved with your treatment, not only to your neurologist.
Huma jistgħu jinnutaw sintomi ġodda li inti forsi ma tinnutax bħal bidliet fil- burdata jew fl- imġieba, telf tal- memorja, diffikultajiet fil- kliem u l- komunikazzjoni, li t- tabib tiegħek għandu mnejn ikollu bżonn jinvestiga aktar biex jelimina PML. • Uri l- Kartuna ta ’ Allarm u dan il- fuljett ta ’ tagħrif lil kull tabib involut fil- kura tiegħek, u mhux biss lin- newrologu tiegħek.
The symptoms of infections include: − an unexplained fever − severe diarrhoea
Is- sintomi ta ’ infezzjonijiet jinkludu: − deni bla spjegazzjoni − dijarea severa − qtugħ ta ’ nifs − sturdament li jdum − uġigħ ta ’ ras − egħbusijja ta ’ l- għonq − telf fil- piż
26 − shortness of breath − prolonged dizziness − headache − stiff neck − weight loss − listlessness.
27 − nuqqas ta ’ enerġija.
• Speak to your doctor as soon as possible if you think you have an infection. • Show the Alert Card and this package leaflet to any doctor involved with your treatment, not only to your neurologist.
• Kellem lit- tabib tiegħek malajr kemm jista ’ jkun jekk taħseb li għandek infezjoni. • Uri l- Kartuna ta ’ Allarm u dan il- fuljett ta ’ tagħrif lil kull tabib involut fil- kura tiegħek, u mhux biss lin- newrologu tiegħek.
You will also find this information in the Patient Alert Card you have been given by your doctor.
Issib dan it- tagħrif ukoll fil- Kartuna ta ’ Allarm tal- Pazjent li ngħatatlek mit- tabib tiegħek.
Will TYSABRI always work?
TYSABRI dejjem se jaħdem?
In a few patients who use TYSABRI, over time the body’ s natural defence may stop TYSABRI from working properly (the body develops antibodies to TYSABRI).
F’ xi pazjenti li jużaw TYSABRI, tul iż- żmien id- diviza naturali tal- ġisem tista ’ twaqqaf lil TYSABRI milli jaħdem kif jixraq (il- ġisem jiżviluppa antikorpi għal TYSABRI).
Your doctor can decide whether TYSABRI is not working properly for you by testing your blood and will stop TYSABRI, if necessary.
It- tabib tiegħek jista ’ jiddeċiedi jekk TYSABRI hux qed jaħdem tajjeb għalik billi jeżamina d- demm tiegħek, u jekk hemm bżonn iwaqqaf TYSABRI.
HOW TO STORE TYSABRI
KIF TAĦŻEN TYSABRI
Store in a refrigerator (2°C to 8°C).
Aħżen fi friġġ (2˚C - 8˚C).
Do not use TYSABRI after the expiry date stated on the label and carton.
Tużax TYSABRI wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kaxxa.
If not used immediately, the diluted solution must be stored at 2˚ C - 8˚ C and infused within 8 hours of dilution.
Jekk ma tintużax minnufih, is- soluzzjoni dilwita għandha tinħażen f’ temperatura ta ’ 2˚C - 8˚C u infuża sa 8 sigħat mid- dilwazzjoni.
Do not use TYSABRI if you notice particles in the liquid and/ or the liquid in the vial is discoloured.
Tużax TYSABRI jekk tinnota xi frak fil- likwidu u/ jew bidla fil- kulur tal- likwidu tal- kunjett.
What TYSABRI contains Each 15 ml vial of concentrate contains 300 mg natalizumab (20 mg/ ml).
X’ fih TYSABRI Kull kunjett ta ’ 15 ml ta ’ konċentrat fih 300 mg natalizumab (20 mg/ ml).
Sodium phosphate, monobasic, monohydrate Sodium phosphate, dibasic, heptahydrate Sodium chloride Polysorbate 80 (E433) Water for injections.
Sodium phosphate, monobasic, monohydrate Sodium phosphate, dibasic, heptahydrate Sodium chloride Polysorbate 80 (E433) Ilma għall- injezzjonijiet.
What TYSABRI looks like and contents of the pack TYSABRI is a clear, colourless to slightly cloudy liquid.
Id- Dehra ta ’ TYSABRI u l- kontenuti tal- pakkett TYSABRI huwa likwidu ċara, bla kulur, għal kemmxejn ikanġi.
Each carton contains one glass vial.
Kull kartuna fiha kunjett wieħed tal - ħġieġ.
27 Marketing Authorisation Holder Elan Pharma International Ltd.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq Elan Pharma International Ltd.
Monksland Athlone County Westmeath Ireland
Monksland Athlone County Westmeath
Manufacturer Biogen Idec B. V.
L- Manifattur Biogen Idec B. V.
For any further information about this medicine, please
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
This information is provided at the end of the leaflet.
Din l- informazzjoni tinstab f’ l- aħħar tal- fuljett.
Tél/ Tel: +32 2 219 12 18
België/ Belgique/ Belgien Biogen Idec Belgium N. V. / SA Tél/ Tel: +32 2 219 12 18
Eesti Richter Gedeon Eesti filiaal Tel: +372 742 0200
Eesti Richter Gedeon EestiEseti filiaal Tel: +372 742 0200
France Biogen Idec France Tél: +33 (0)1 41 37 95 95
România France Biogen Idec France Tél: +33 (0) 1 41 37 95 95
Italia Biogen-Dompé s. r. l.
29 Italia Biogen- Dompé s. r. l.
Tel: +37 16 784 5338
Tel: +37 16 748 5338
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 Ewropeja 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:
Remove flip-top from the vial.
Neħħi l- għatu flip- off mill- kunjett.
Gently invert the TYSABRI solution to mix completely.
Aqleb bil- mod ta ’ taħt fuq is- soluzzjoni biex tħallat kollox.
Visually inspect the diluted product for particles or discolouration prior to administration.
5 Spezzjona il- prodott dilwit għall- frak jew tibdil fil- kulur qabel l- għotja.
If the diluted product is stored at 2°C - 8°C (do not freeze), allow the solution to warm to room temperature prior to infusion.
Jekk il - prodott dilwit huwa maħżun f’ 2˚C - 8˚C (tiffriżax), ħalli is- soluzzjoni tilħaq it- temperatura tal - kamra qabel l- infużjoni.
What is Tyverb?
X’ inhu Tyverb?
Tyverb is a medicine containing the active substance lapatinib.
Tyverb huwa mediċina li fiha s- sustanza attiva lapatinib.
It is available as yellow, oval tablets (250 mg).
Din tiġi bħala pilloli sofor ovali (250 mg).
What is Tyverb used for?
Għal xiex jintuża Tyverb?
Tyverb is used to treat patients with advanced or metastatic breast cancer which has been shown to be ‘ expressing’ large amounts of ErbB2.
Tyverb jintuża fit- trattament ta ’ pazjenti b’ kanċer tas- sider avvanzat jew metastatiku li jkun juru li ‘ jesprimi ’ ammonti kbar ta ’ ErbB2.
This means that the cancer produces (expresses) a specific protein called ErbB2 (also known as HER2) in large quantities on the surface of the tumour cells. ‘ Metastatic’ means that the cancer has spread to other parts of the body.
Dan ifisser li l- kanċer jipproduċi (jesprimi) protejina speċifika msejħa ErbB2 (magħrufa wkoll bħala HER2) fi kwantitajiet kbar fil- wiċċ taċ- ċelluli tat- tumur. ‘ Metastatiku ’ ifisser li l- kanċer ikun infirex għal partijiet oħra tal- ġisem.
Tyverb is used in combination with capecitabine (another anticancer medicine).
Tyverb jintuża flimkien ma ’ kapeċitabina (mediċina oħra kontra l- kanċer).
It is only used in patients whose disease is getting worse following previous treatment including an anthracycline and a taxane (other types of anticancer medicine), and following treatment of their metastatic disease with trastuzumab (another anticancer medicine).
Jintuża biss f’ pazjenti li l - marda tagħhom tkun qed tiggrava wara trattament inkluż antraċiklina u taksejn (anthracycline u taxane) (tipi oħra ta ’ mediċina kontra l- kanċer), u wara trattament tal- marda metastatika tagħhom bit - trastużumab (mediċina oħra kontra l- kanċer).
How is Tyverb used?
Kif jintuża Tyverb?
Tyverb should only be initiated by a doctor who has experience in giving anticancer medicines.
Tyverb għandu jkun mibdi biss minn tabib bl- esperjenza fl- għoti ta ’ mediċini kontra l- kanċer.
The recommended dose of Tyverb is five tablets once a day.
Id- doża rakkomandata ta ’ Tyverb hija ta ’ ħames pilloli darba kuljum.
All five tablets must be taken at the same time, at least one hour before or one hour after food.
Il- ħames pilloli għandhom jittieħdu f’ daqqa, talanqas siegħa qabel jew siegħa wara l- ikel.
Each patient should take the medicine at the same time each day with respect to food, such as always before or always after a meal.
Kull pazjent għandu jieħu l- mediċina fl- istess ħin kuljum skond l- ikel, bħal pereżempju dejjem qabel jew dejjem wara ikla.
The doctor may decide to interrupt or stop treatment in patients experiencing certain side effects, especially those affecting the heart, lungs or liver.
It- tabib jista ’ jiddeċiedi l- interruzzjoni jew il- waqfa tat- trattament ta ’ pazjenti li jkunu qegħdin jesperjenzaw effetti sekondarji partikolarment dawk li jaffettwaw il- qalb, il- pulmun jew il- fwied.
If patients start to take Tyverb again, they may need to use a lower dose.
Jekk pazjenti jerġgħu jibdew jieħdu Tyverb, jista ’ jkun li jkollhom jużaw doża inqas.
Patients who stop taking Tyverb after developing severe liver problems should not start to take the medicine again.
Pazjenti li jieqfu milli jieħdu Tyverb wara li jiżviluppaw problemi gravi tal- fwied m’ għandhomx jerġgħu jieħdu l- mediċina mill- ġdid.
Tyverb should be used with caution in patients who have severe kidney problems or moderate to severe liver problems.
Tyverb għandu jintuża b’ kawtela f’ pazjenti li jkollhom problemi gravi fil- kliewi jew problemi tal - fwied li jkunu bejn stat moderat u gravi.
How does Tyverb work?
Kif jaħdem Tyverb?
The active substance in Tyverb, lapatinib, belongs to a group of medicines called protein kinase inhibitors.
Is- sustanza attiva f’ Tyverb, lapatinib, tappartjeni għal grupp ta ’ mediċini msejħa inibituri tal- protejina kinażi.
These compounds act by blocking types of enzymes known as protein kinases.
Dawn il- komposti jaġixxu billi jibblokkaw tipi ta ’ enzimi magħrufa bħala protejini kinażi.
These enzymes can be found in some receptors on the surface of cancer cells, including ErbB2, which is a receptor for epidermal growth factor.
Dawn l- enzimi jistgħu jinsabu f’ xi riċetturi fuq il- wiċċ ta ’ ċelluli tal- kanċer, inkluż ErbB2, li huwa riċettur għall- fattur tat- tkabbir epidermali.
Reproduction is authorised provided the source is acknowledged. uncontrollably.
Reproduction is authorised provided the source is acknowledged. diviżjoni mhux kontrollata.
By blocking these receptors, Tyverb helps to control cell division.
Billi jimblokka dawn ir- riċetturi, Tyverb jgħin biex jikkontrolla d - diviżjoni taċ- ċelluli.
About a quarter of breast cancers express ErbB2.
Madwar kwart tal- każijiet tal- kanċer tas- sider juri ErbB2.
How has Tyverb been studied?
Kif ġie studjat Tyverb?
The effects of Tyverb were first tested in experimental models before being studied in humans.
L- effetti ta ’ Tyverb ġew ittestjati għall- ewwel darba b’ mudelli esperimentali qabel ma ’ ġew studjati fuq il- bniedem.
Tyverb was studied in one main study involving 408 women with advanced or metastatic breast cancer that was expressing large quantities of ErbB2.
Tyverb kien studjat fi studju ewlieni li involva 408 nisa b’ kanċer tas- sider avvanzat jew metastatiku li kien juri kwantitajiet kbar ta ’ ErbB2.
The women had already been treated with anthracyclines, taxanes and trastuzumab but their disease had got worse or come back.
In- nisa kienu diġà ġew ittrattati b’ antraċiklini, taksejns u trastużumab iżda l- marda tagħhom kienet marret għall- agħar jew reġgħet inbdiet.
The study compared the effectiveness of Tyverb in combination with capecitabine with that of capecitabine alone.
L- istudju qabbel l - effikaċja ta ’ Tyverb flimkien mal- kapeċitabina ma ’ l- effikaċja tal- kapeċitabina waħedha.
The main measure of effectiveness was the time until the disease got worse, which was assessed in scans about every six weeks.
Il- kejl ewlieni ta ’ l- effikaċja kien il- ħin sa meta l- marda marret għall- agħar, li kien eżaminat fi skens madwar kull sitt ġimgħat.
What benefit has Tyverb shown during the studies?
X' benefiċċji ta 'Tyverb intwerew f' dawn l- istudji?
Tyverb in combination with capecitabine was more effective than capecitabine alone.
Tyverb flimkien ma kapeċitabina kien iktar effikaċi mill- kapeċitabina waħedha.
On average, as assessed by the patients’ doctors, adding Tyverb increased the time until the disease got worse from 18.3 to 23.9 weeks.
Bħala medja, skond valutazzjonijiet li wettqu t- tobba tal- pazjenti, bl- użu ta ’ Tyverb, iż- żmien sa meta l- marda marret għall- agħar twal minn 18. 3 sa 23. 9 ġimgħat.
However, at the time of the medicine’ s assessment, it was difficult to determine within this study whether adding Tyverb had increased the patients’ survival times or not.
Madankollu, fil- ħin tal- valutazzjoni tal- mediċina, kien diffiċli li jiġi determinat f’ dan l- istudju jekk l- użu ta ’ Tyverb kien żied iż- żmien ta ’ sopravivenza tal - pazjenti jew le.
What is the risk associated with Tyverb?
X' inhu r- riskju assoċjat ma 'Tyverb?
The most common side effects with Tyverb in combination with capecitabine (seen in more than 1 patient in 10) are diarrhoea (which may lead to dehydration), nausea (feeling sick), vomiting, rash, anorexia (loss of appetite), fatigue (tiredness), dyspepsia (indigestion), dry skin, stomatitis (inflammation of the lining of the mouth), constipation, abdominal (tummy) pain, palmar-plantar erythrodysaesthesia (redness and pain on the hands and feet), pain in the extremities (hands and feet), back pain, inflammation of the mucous membranes (moist body surfaces) and insomnia (difficulty sleeping).
L- effetti sekondarji ta ’ Tyverb flimkien mal- kapeċitabina (li dehru f’ iktar minn wieħed minn kull 10 pazjent) huma id- dijarrea (li tista ’ twassal għall- diżidratazzjoni), in- nawżea (dardir), l- irrimettar, raxx, l- anoressija (nuqqas ta ’ aptit), għeja kbira, dispepsija (indiġestjoni), ġilda xotta, stomatite (infjammazzjoni tar- rita tal- ħalq), konstipazzjoni, uġigħ addominali (fiż- żaqq), eritrodisestesija palmo - plantari (ħmura u uġigħ fuq l- idejn u s- saqajn), uġigħ fl- idejn u s- saqajn, uġigħ fid- dar, infjammazzjoni tal- membrana mukuża (wiċċ tal- ġisem li tkun niedja) u insonnja (diffikultà fl- irqad).
For the full list of all side effects reported with Tyverb, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha rrappurtati b’ Tyverb, ara l- Fuljett ta' Tagħrif.
Tyverb should not be used in people who may be hypersensitive (allergic) to lapatinib or any of the other ingredients.
Tyverb m’ għandux jintuża minn persuni allerġiċi għal lapatinib jew għal xi ingredjenti oħra tiegħu.
Why has Tyverb been approved?
Għaliex ġie approvat Tyverb?
The Committee for Medicinal Products for Human Use (CHMP) decided that Tyverb’ s benefits are greater than its risks, in combination with capecitabine, for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpress ErbB2 (HER2).
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Tyverb huma ikbar mir- riskji tiegħu, meta jintuża ma ’ kapeċitabina, għat- trattament ta ’ pazjenti b’ kanċer tas- sider avvanzat jew metastatiku li t- tumur tagħhom ikunu juru ż- żejjed ErbB2 (HER2).
The Committee recommended that Tyverb be given marketing authorisation.
Il - Kumitat irrakkomanda li Tyverb jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Tyverb has been given ‘ Conditional Approval’.
Tyverb ingħata ‘ Approvazzjoni Kundizzjonali ’.
This means that there is more evidence to come about the medicine, in particular its effects on survival and on the spread of breast cancer.
Dan ifisser li għad irid ikun hemm iktar evidenza dwar din il- mediċina, b’ mod partikolari l- effetti tagħha fuq is- sopravivenza u t0tixrid tal- kanċer tas - sider.
Every year, the European Medicines Agency (EMEA) will review any new information that may have become available and this summary will be updated as necessary.
Kull sena, l- Aġenzija Ewropea għall- Mediċini (EMEA) ser tirrevedi kwalunkwe tagħrif ġdid li jista 'jinkiseb u dan is- sommarju jiġi aġġornat kif meħtieġ.
What information is still awaited for Tyverb?
Liema informazzjoni għadha mistennija għal Tyverb?
The company that makes Tyverb will provide an updated analysis of the effects of Tyverb on survival times of patients in the main study.
Il- kumpanija li tipproduċi Tyverb se tipprovdi analiżi aġġornata ta ’ l- effetti ta ’ Tyverb fuq iż- żmien ta ’ sopravivenza ta ’ pazjenti fl- istudju ewlieni.
It will also perform a study comparing the effects of treatment containing Tyverb and a treatment containing trastuzumab on the spread of cancer to the brain.
Ser twettaq ukoll studju li jqabbel l- effetti tat - trattament li fih Tyverb u trattament li fih trastużumab fuq il- firxa tal- kanqer għall- moħħ.
Other information about Tyverb:
Tagħrif ieħor dwar Tyverb:
The European Commission granted a marketing authorisation valid throughout the European Union for Tyverb to Glaxo Group Limited on 10 June 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Tyverb valida fl- Unjoni Ewropea kollha lil Glaxo Group Limited fi x ta ’ 10 Ġunju 2008.
The full EPAR for Tyverb can be found here.
L- EPAR sħiħ għal Tyverb jista ’ jiġi kkonsultat hawn.
EU Number EU/ 1/ 07/ 440/ 001 EU/ 1/ 07/ 440/ 002
Numru ta ’ l- EU EU/ 1/ 07/ 440/ 001 EU/ 1/ 07/ 440/ 002
Invented name Tyverb Tyverb
Isem ivvintat Tyverb Tyverb
Strength 250 mg 250 mg
Qawwa 250 mg 250 mg
Route of administration Oral use Oral use
Mnejn jingħata Użu orali Użu orali
Packaging Blister (PA/ Alu/ PVC/ Alu) Blister (PA/ Alu/ PVC/ Alu)
Kontenut Folja blister (PA/ Alu/ PVC/ Alu) Folja blister (PA/ Alu/ PVC/ Alu)
Package size 70 tablets 2x70 tablets
Daqs tal- pakkett 70 pillola 2x70 pillola
SUMMARY OF PRODUCT CHARACTERISTICS 1.
SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT 1.
Tyverb 250 mg film-coated tablets
Tyverb 250 mg pilloli miksijin b’ rita
Each film-coated tablet contains lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib.
Kull pillola miksija b’ rita fiha lapatinib ditosylate monohydrate, ekwivalenti għal 250 mg lapatinib.
Oval, biconvex, yellow film-coated tablets, with “ GS XJG ” debossed on one side.
Pilloli ovali, konvessi fuq iż- żewġ naħat, sofor miksijin b’ rita, b ’ “ GS XJG ” imħaffra fuq naħa waħda.
Tyverb, in combination with capecitabine, is indicated for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpress ErbB2 (HER2).
Tyverb, flimkien ma capecitabine, huwa indikat għall- kura ta ’ pazjenti b’ kanċer tas- sider avvanzat jew metastatiku li t- tumuri tagħhom jesprimu ErbB2 (HER2) żejjed.
Patients should have progressive disease following prior therapy which must include anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting (see section 5.1).
Il- pazjenti għandu jkollhom marda progressiva wara li tkun diġà ingħatat terapija li għandha tinkludi anthracyclines u taxanes u terapija bi trastuzumab fi sfond ta ’ metastasi (ara sezzjoni 5. 1).
Lapatinib treatment should only be initiated by a physician experienced in the administration of anti- cancer agents.
Kura b’ Lapatinib għandha tinbeda biss minn tabib b’ esperjenda fl- għoti ta ’ aġenti kontra l- kanċer.
ErbB2 overexpressing tumours are defined by IHC3+, or IHC2+ and gene amplification or gene amplification alone.
Tumuri li jesprimu ErbB2 żejjed huma definiti b’ IHC3+, jew IHC2+ u amplifikazzjoni tal- ġene jew amplifikazzjoni tal- ġene biss.
Gene amplification should be performed using an accurate and validated assay.
L- amplifikazzjoni tal- ġene għandha ssir permezz ta ’ l- użu ta ’ assay preċiż u validat.
Lapatinib is taken in combination with capecitabine.
Lapatinib jittieħed flimkien ma ’ capecitabine.
The recommended dose of lapatinib is 1250 mg (i. e. five tablets) once daily continuously.
Id- doża rakkommandata ta ’ lapatinib hija ta ’ 1250mg (jiġifieri ħames pilloli) darba kuljum kontinwament.
The daily dose should not be divided.
Id- doża ta ’ kuljum m’ għandhiex titqassam matul il- jum.
Lapatinib should be taken either at least one hour before, or at least one hour after food.
Lapatinib għandu jittieħed mill- anqas jew siegħa qabel jew mill- anqas siegħa wara l- ikel.