qanastek/EMEA-V3 huggingface dataset:
Glaxo Group Limited, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom.
Glaxo Group Limited, Berkeley Avenue, Greenford, Middlesex UB6 0NN, Ir- Renju Unit.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu. / >
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA) http: // www. emea. europa. eu. / >
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL - HRUĠ TAL- LOTT
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- manifatturi responsabbli għall- ħruġ tal- lott.
Glaxo Operations UK Limited Priory Street Ware Hertfordshire SG12 0DG United Kingdom
Glaxo Wellcome Operations UK Limited Priority Street Ware Hertfordshire SG12 ODJ Renju Unit.
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIŻŻAZZJONI GĦAT- TQEGĦID FIS- SUQ
Summary of Product Characteristics, section 4.2).
Sommarju tal- Karatteristiċi tal- Prodott, sezzjoni, 4. 2)
Not aplicable.
Ma ’ jgħoddx f’ dan il- każ.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 3 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza L- MAH għandu jassigura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ verżjoni 3 ippreżentata fil- Module 1. 8. 1 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq hija f’ postha u tiffunzjona qabel u waqt li l- prodott ikun fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4a of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan ta ’ Immaniġġjar tar- Riskju L- MAH jikkommetti li jwettaq l- istudji u l- attivitajiet addizjonali ta ’ farmakoviġilanza ddettaljati fil- Pjan ta 'Farmakoviġilanza kif miftiehem f’ verżjoni 4a tal- Pjan għall- Immaniġġjar tar- Riskju (RMP) ippreżentat f’ Module 1. 8. 2 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u kull aġġornament ta ’ l - RMP iffissat mis- CHMP li jiġi wara.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Ġwida tas- CHMP fuq is- Sistemi għall- Immaniġġjar tar- Riskju għall- prodotti mediċinali għall- użu fil- bniedem, l- RMP aġġornata għandha tiġi sottomessa fl- istess ħin mar- Rapport Perjodiku ta ’ l - Aġġornament għas- Sigurtà (PSUR).
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
OBBLIGAZZJONIJIET SPEĊIFIĊI TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame.
Id- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jtemm il- programm ta 'studji li ġejjin fiż - żmien speċifikat.
The results of which shall be taken into account in the risk benefit balance during the assessment of the application for a renewal.
Ir- riżultati ta 'dawn għandhom jittieħdu f’ kunsiderazzjoni fil- bilanċ bejn il - benefiċċju/ riskju waqt l- assessjar ta ’ l- applikazzjoni għal tiġdid.
To perform and submit an updated analysis of survival data for study EGF100151.
Biex isir u jkun sottomess analiżi aġġornata tad- dejta ta ’ sopravivenza mill- istudju EGF100151.
A data cut-off date of August 2008 will be applied, with the results of the analysis to be submitted by December 2008.
Se tiġi applikata data ta 'skadenza sa Awissu 2008, u r- riżultati ta ’ l- analiżi jiġu sottomessi sa Diċembru 2008.
To conduct a Phase III randomised, controlled clinical study to evaluate the incidence of brain metastases as the site of relapse with a lapatinib-containing therapy compared with an appropriate, trastuzumab-containing control arm.
Biex isir studju kliniku, kontrollat, randomised ta ’ Fażi III biex issir evalwazzjoni ta ’ l- inċidenza ta ’ metastasi fil- moħħ bħala sit ta ’ rkadenza b’ terapija li jkun fiha lapatinib meta mqabbla ma ’ fergħa ta ’ kontroll approprjata li fiha trastuzumab.
The study protocol will be finalised and submitted to the EMEA by July 2008.
Il- protokoll ta ’ l- istudju se jkun finaliżżat u sottomess lil EMEA sa Lulju 2008.
The final study report for the trial will by submitted by May 2013.
Ir- rapport finali ta ’ l - istudju se jkun sottomess sa Mejju 2013.
15 A. LABELLING
15 ANNESS III
OUTER CARTON (14 DAY, SINGLE PACK)
KARTUNA TA ’ BARRA (14- IL ĠURNATA, PAKKETT WIEĦED)
Tyverb 250 mg film-coated tablets lapatinib
Tyverb 250 mg pilloli miksijin b’ rita lapatinib
70 film-coated tablets
70 pillola miksijin b’ rita
Glaxo Group Ltd, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom
Glaxo Group Ltd, Berkeley Avenue, Greenford, Middlesex UB6 0NN, Ir- Renju Unit.
INSTRUCTIONS ON USE
STRUZZJONIET DWAR L- UŻU
OUTER CARTON (28-DAY, MULTIPACK)
KARTUNA TA ’ BARRA (28 ĠURNATA, PAKKETT MULTIPLU)
140 film-coated tablets Multipack comprising 2 packs, each containing 70 film-coated tablets
140 pillola miksijin b’ rita Pakkett multiplu magħmul minn 2 pakketti, kull wieħed fih 70 pillola miksijin b’ rita
OUTER CARTON (14 DAY PACK, PART OF 28 DAY MULTIPACK)
KARTUNA TA ’ BARRA (PAKKETT TA ’ 14- IL- ĠURNATA, PARTI MINN PAKKETT MULTIPLU TA ’ 28 ĠURNATA)
Component of the multipack, not to be sold separately
Jagħmel parti minn pakkett multiplu, mhux biex jinbiegħ separatament
Tyverb 250 mg tablets lapatinib
Tyverb 250 mg pilloli lapatinib
EXPIRY DATE
DATA TA META JISKADI
Tyverb 250 mg film-coated tablets Lapatinib
Tyverb 250 mg pilloli miksijin b’ rita Lapatinib
Don’ t pass it on to others.
M’ għandekx tgħaddiha lil persuni oħra.
their symptoms seem the same as yours.
ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
What Tyverb is and what it is used for 2.
X’ inhu Tyverb u għalxiex jintuża 2.
Before you take Tyverb 3.
Qabel ma tieħu Tyverb 3.
How to take Tyverb 4.
Kif għandek tieħu Tyverb 4.
How to store Tyverb 6.
Kif taħżen Tyverb 6.
WHAT TYVERB IS AND WHAT IT IS USED FOR
X’ INHU TYVERB U GĦALXIEX JINTUŻA
Tyverb is used to treat certain types of breast cancer.
Tyverb jintuża biex jikkura ċerti tipi ta ’ kanċer tas- sider.
It may slow or stop cancer cells from growing, or may kill them.
Huwa jista ’ jnaqqas jew iwaqqaf iċ- ċelluli tal - kanċer milli jikbru, jew jista ’ joqtolhom.
While taking Tyverb you will also take another medicine containing the active substance capecitabine to treat cancer.
Waqt li tkun qed tieħu Tyverb inti tkun qed tieħu mediċina oħra li fiha is- sustanza attiva capecitabine biex tikkura l- kanċer.
Information about capecitabine, is described the capecitabine patient information leaflet.
Informazzjoni dwar capecitabine, hija deskritta fil- fuljett ta ’ tagħrif għall- pazjent ta ’ capecitabine.
Ask your doctor to give you information about capecitabine.
Staqsi lit- tabib tiegħek biex itik informazzjoni dwar capecitabine.
BEFORE YOU TAKE TYVERB
QABEL MA TIEĦU TYVERB
Do not take Tyverb
Tieħux Tyverb
- if you are allergic (hypersensitive) to lapatinib or any of the other ingredients of Tyverb.
- Jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal lapatinib jew xi sustanzi oħra ta ’ Tyverb.
Take special care with Tyverb
Oqogħod attent ħafna b’ Tyverb
Your doctor will run tests to check that your heart is working properly before and during your treatment with Tyverb.
It- tabib tiegħek se jgħammillek testijiet biex jara li qalbek qed taħdem tajjeb qabel u waqt il- kura tiegħek b’ Tyverb.
− Tell your doctor if you have any heart problems before you take Tyverb.
− Għid lit- tabib tiegħek jekk għandek xi problemi f’ qalbek qabel ma ’ tieħu Tyverb.
Your doctor also needs to know before you take Tyverb: − If you have any liver problems. − If you have any kidney problems.
It- tabib tiegħek għandu jkun jaf ukoll qabel ma tieħu Tyverb: − Jekk għandekx xi problemi fil- fwied. − Jekk għandekx xi problemi fil- kliewi.
Your doctor will run tests to check that your liver is working properly before and during your treatment with Tyverb.
It- tabib tiegħek jagħmillek testijiet biex jara li l- fwied tiegħek ikun qed jaħdem sew qabel u waqt il - kura tiegħek b’ Tyverb.
Tell your doctor if any of these apply to you.
Għid lit- tabib tiegħek jekk xi waħda minn dawn tapplika għalik.
25 Tell your doctor or pharmacist if you are taking, or have recently taken any other medicines.
26 Meta tieħu mediċini oħra Għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew dan l- aħħar ħadt xi mediċini oħra.
This includes any medicines you bought without a prescription.
Dan jinkludi xi mediċini li xrajt mingħajr riċetta.
It is especially important to tell your doctor if you are taking, or have recently taken any of the following medicines.
Huwa speċjalment importanti li tgħid lit- tabib tiegħek jekk inti qed tieħu jew dan l- aħhar ħadt xi waħda minn dawn il- mediċini li ġejjin.
Some medicines may affect the way Tyverb works or Tyverb may affect how other medicines work.
Xi mediċini jistgħu jaffettwaw il- mod kif jaħdem Tyverb jew Tyverb jista ’ jaffetwa l- mod kif jaħdmu mediċini oħra.
These medicines include some medicines in the following groups: − erythromycin, ketoconazole, itraconazole, posaconazole, voriconazole, rifabutin, rifampicin, telithromycin – medicines used to treat infections − cyclosporine – a medicine used to suppress the immune system for example after organ transplantations − ritonavir, saquinavir – medicines used to treat HIV − phenytoin, carbamazepine – medicines used to treat seizures − cisapride – a medicine used to treat certain digestive system problems − pimozide – a medicine used to treat certain psychological illnesses − quinidine, digoxin – medicines used to treat certain heart problems − repaglinide – a medicine used to treat diabetes − verapamil – a medicine used to treat high blood pressure or angina − nefazodone – a medicine used to treat depression − St John’s Wort – a herb extract used to treat depression − topotecan, paclitaxel – medicines used to treat certain types of cancer − rosuvastatin – a medicine used to treat high cholesterol − drugs that decrease stomach acidity (used to treat stomach ulcers or indigestion)
John’ s Wort – estratt minn ħaxixa użat biex jikkura depressjoni − topotecan, paclitaxel – mediċini użati biex jikkuraw ċerti tipi ta ’ kanċer − rosuvastatin – mediċina użata biex tikkura livelli għolja ta ’ kolesterol − mediċini li jnaqqsu l- aċidità fl- istonku (użati fil- kura ta ’ ulċeri fl- istonku jew indiġistjoni)
Tell your doctor if you’re taking, or have recently taken, any of these.
Għid lit- tabib tiegħek jekk qed tieħu, jew dan l- aħħar ħadt xi waħda minn dawn.
Your doctor will review the medicines you are currently taking to make sure you are not taking something that can’t be taken with the Tyverb.
It- tabib tiegħek se janalizza mill- ġdid l- mediċini li qed tieħu bħalissa biex jiżgura li inti m’ intix qed tieħu xi ħaġa li ma tistax tittieħed flimkien ma ’ Tyverb.
You r doctor will advise you whether an alternative is available.
It- tabib tiegħek jagħtik parir dwar jekk hemmx alternattiva.
Taking Tyverb with food and drink Tyverb is affected by food intake.
Meta tieħu Tyverb ma ’ l- ikel u max- xorb Tyverb huwa affettwat mit- teħid ta ’ l- ikel.
You should take Tyverb either at least one hour before or at least one hour after food.
Inti għandek tieħu Tyverb mill- anqas siegħa qabel jew mill- anqas siegħa wara l- ikel.
It is important that you take your tablets at the same time in relation to food each day.
Huwa importanti li inti tieħu l- pilloli kuljum fl- istess ħin skond kif tiekol.
For example, always take your tablet one hour before breakfast.
Per eżempju dejjem ħu l- pilloli siegħa qabel il- kolazzjon.
You should not drink grapefruit juice while you are being treated with Tyverb.
Inti m’ għandex tixrob meraq tal- grejpfrut waqt li tkun qed tingħata kura b’ Tyverb.
Pregnancy and breast-feeding The effect of Tyverb during pregnancy is not known.
Tqala u treddigħ L- effett ta ’ Tyverb waqt it- tqala m’ huwiex magħruf.
It is not known whether Tyverb passes into breast-milk.
Inti m’ għandekx tuża Tyverb jekk inti tqila sakemm ma jirrakkomandahx speċifikament it- tabib tiegħek. − Jekk inti tqila jew qed tippjana biex toħroġ tqila għid lit- tabib tiegħek. − Uża metodu sikur ta ’ kontraċezzjoni biex tevita li toħroġ tqila waqt li kun qed tieħu Tyverb. − Jekk toħroġ tqila waqt kura b’ Tyverb, għid lit- tabib tiegħek. − M’ huwiex magħruf jekk Tyverb jgħaddix fil- ħalib tas- sider.
Do not breast-feed while taking Tyverb. − If you are breast-feeding or planning to breast-feed, tell your doctor.
Treddgħax waqt li tieħu Tyverb. − Jekk qed tredda ’ jew qed tippjana biex tredda ’, għid lit- tabib tiegħek.
Ask your doctor or pharmacist for advice before taking Tyverb if you are unsure.
Staqsi lit- tabib jew lill- ispiżjar tiegħek għall- parir qabel tieħu Tyverb jekk m’ intix ċerta.
Driving and using machines No studies have been performed on the effects of Tyverb on your ability to drive or use machines.
Sewqan u tħaddim ta ’ magni Ma saru l- ebda studji dwar l- effetti ta ’ Tyverb fuq il- ħila tiegħek li issuq u tħaddem magni.
You are responsible to decide if you are able to drive a motor vehicle or perform other tasks that require increased concentration.
Inti responsabbli li tiddeċiedi jekk tistax issuq vettura bil- mutur jew tagħmel biċċa xogħol li għaliha hemm bżonn żieda fil- konċentrazzjoni.
Because of the possible side effects of Tyverb, your ability to drive or operate machinery could be affected.
Minħabba l- effetti sekondarji li Tyverb jista ’ jkollu, il- ħila tiegħek li ssuq u tħaddem magni tista ’ tkun affettwata.
Descriptions of these effects can be found in the “Possible side effects” section.
Deskrizzjonijiet ta ’ dawn l- effetti jistgħu jinstabu fis- sezzjoni “ Effetti sekondarji li jista ’ jkollu ”.
26 Read all the information in this leaflet for guidance.
Aqra l- informazzjoni kollha f’ dan il- fuljet bħala gwida.
Discuss with your doctor, nurse or pharmacist if you are unsure about anything.
Iddiskuti mat- tabib, infermier jew spiżjar tiegħek jekk ikollok xi dubju dwar kwalunkwe ħaġa.
HOW TO TAKE TYVERB
KIF TIEĦU TYVERB
Always take Tyverb exactly as your doctor has told you.
Dejjem ħu Tyverb eżatt skond kif qallek it- tabib tiegħek.
Check with your doctor or pharmacist if you’re not sure.
Aċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju.
− The usual dose is five Tyverb tablets a day.
− Id- doża tas- soltu hija ta ’ ħames pilloli Tyverb kuljum.
Five Tyverb tablets will give you a total dose of 1250 mg a day. − Swallow the five tablets whole with water, one after the other, at the same time each day.
Ħames pilloli Tyverb jagħtuk doża totali ta ’ 1250 mg kuljum. − Ibla ’ il- ħames pilloli sħaħ ma ’ l- ilma, waħda wara l- oħra, kuljum fl- istess ħin.
− You should take Tyverb either at least one hour before or at least one hour after food.
− Inti għandek tieħu Tyverb jew mill- anqas siegħa qabel jew mill- anqas siegħa wara l- ikel.
It is important that you take your tablets at the same time in relation to food each day.
Huwa importanti li inti tieħu l- pillloli kuljum fl- istess ħin skond kif tiekol.
For example, always take your tablets one hour before breakfast. − Depending on your response to treatment, your doctor may recommend lowering your dose or temporarily stopping your treatment. − Your doctor will also carry out blood tests to check your liver function before and during treatment with Tyverb. − You will take another medicine containing the active substance capecitabine while you are taking Tyverb.
Per eżempju, dejjem ħu il- pilloli siegħa qabel il- kolazzjon. − Skond kif inti tirrispondi għall- kura, it- tabib tiegħek jista ’ jirrakkomanda tnaqqis fid- doża jew waqfien temporanju mill- kura. − It- tabib tiegħek jagħmillek ukoll testijet tad- demm biex jiċċekja il- funzjoni tal- fwied tiegħek qabel u waqt kura b’ Tyverb. − Inti se tieħu mediċina oħra li fiha s- sustanza attiva capecitabine waqt li inti tkun qed tieħu Tyverb.
Your doctor will advise you about the dose of capecitabine, when to take it and how often.
It - tabib tiegħek jagħtik parir dwar id- doża ta ’ capecitabine, meta teħodha u kemm frekwenti.
If you take too much Tyverb Contact a doctor or pharmacist immediately.
Jekk tieħu aktar Tyverb milli suppost Ikkuntattja tabib jew spiżjar immedjatament.
If possible show them the pack.
Jekk inhu possibbli urihom il- pakkett.
If you forget to take Tyverb Don’t take a double dose to make up for a missed dose.
Jekk tinsa ’ tieħu Tyverb Tieħux doża doppja biex tpatti għad- doża li nsejt tieħu.
Just take the next dose at the scheduled time.
Sempliċement ħu d- doża li jmiss fil- ħin skedat.
Like all medicines, Tyverb can cause side effects, although not everybody gets them.
Bħal kull mediċina, Tyverb jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
(These may affect more than 1 in 10 people treated with Tyverb in combination with capecitabine).
(Dawn jistgħu jaffetwaw aktar minn persuna waħda minn kull 10 ikkurati b’ Tyverb flimkien ma’ capecitabine).
- Diarrhoea (which may make you dehydrated)
- Dijarea (li tista ’ tagħmlek deidratat/ a)
- Tell your doctor if you get diarrhoea.
- Għid lit- tabib tiegħek jekk ikollok dijarea.
Other very common side effects include:
Effetti sekondarji oħra komuni ħafna jinkludu:
- Loss of appetite
- Telf t’ aptit
- Feeling sick (nausea)
- Tħossok imdardar/ imdardra (nawsja)
- Being sick (vomiting)
- Tirremetti (tivvomta)
- Rash
- Raxx
- Tiredness
- Għeja
- Indigestion
- Indiġistjoni
- Sore mouth/mouth ulcers
- Feriti fil- ħalq/ ulċeri fil- ħalq
- Stomach pain
- Uġigħ fl- istonku
- Trouble sleeping
- Problema biex torqod
- Back pain
- Uġigħ fid- dahar
- Pain in hands and feet
- Uġigħ fl- idejn u s- saqajn
- Dry skin
- Ġilda xotta
- A skin reaction on the palms of the hands or soles of the feet (including tingling, numbness,
- Reazzjoni fil- ġilda fil- paliet ta ’ l- idejn u s- saqajn (inkluż tingiż, tnemnim, uġigħ, nefħa jew ħmura)
Tell your doctor if any of these side effects get severe or troublesome.
- Għid lit- tabib tiegħek jekk xi wieħed minn dawn l- effetti jaggrava jew idejqek.
Common side effects
28 Effetti sekondarji komuni
(These may affect up to 1 in 10 people treated with Tyverb in combination with capecitabine).
(Dawn jistgħu jaffettwaw sa persuna waħda minn kull 10 persuni kkurati b’ Tyverb flimkien ma ’ capecitabine)
- An effect on how your hearts works
- Effett fuq il- mod kif taħdem qalbek
In most cases, the effect on your hearts function will not have any symptoms.
F’ ħafna mill- każijiet, l- effett fuq il- funzjoni ta ’ qalbek ma ’ jkollu l- ebda sintomi.
If you do experience symptoms associated with this side effect, these are likely to include an irregular heartbeat and shortness of breath.
Jekk inti tesperjenza sintomi assoċjati ma ’ dan l- effett sekondarju, dawn x’ aktarx jinkludu taħbit irregolari tal- qalb u qtugħ ta ’ nifs.
− Liver problems, which may cause itching, yellow eyes or skin (jaundice), or dark urine or pain or discomfort in the right upper area of the stomach.
jew uġigħ jew dwejjaq fuq in- naħa tal- lemin u ta ’ fuq ta ’ l- istonku.
- Tell your doctor if you get any of these symptoms.
- Għid lit- tabib tiegħek jekk ikollok xi sintomi minn dawn.
Other common side effects
Effetti sekondarji komuni oħra
− Tell your doctor or pharmacist if this side effect gets severe or troublesome.
− Għid lit- tabib jew lill- ispiżjar tieħek jekk dan l- effett sekondarju jiggrava jew idejqek.
(These may affect up to 1 in 100 people treated with Tyverb in combination with capecitabine).
(Dawn jistgħu jaffettwaw sa pesuna waħda minn kull 100 ikkurati b’ Tyverb flimkien ma ’ capecitabine). − Infjammazzjoni tal- pulmun ikkaġunata mill- mediċina, li tista ’ tikkawża qtugħ ta ’ nifs jew sogħla
Tell your doctor immediately if you get either of these symptoms.
Għid lit- tabib tiegħek immedjatament jekk ikollok xi wieħed minn dawn is- sintomi.
Other uncommon side effects include: − blood tests results that show changes in liver function (usually mild and temporary)
Effetti sekondarji oħra mhux komuni jinkludu: − riżultati tat- testijiet tad- demm li juru tibdil fil- funzjoni tal- fwied (ġeneralment ħafif u temporanju)
If you get other side effects
Jekk ikollok effetti sekondarji oħra
- If you notice any side effects not listed in this leaflet:
- Jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett:
Tell your doctor or pharmacist.
Għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE TYVERB
KIF TAĦŻEN TYVERB
Do not use Tyverb after the expiry date which is stated on the blister and the carton.
Tużax Tyverb wara d- data ta ’ skadenza li tidher fuq il- folja u l- kartuna.
Do not store above 30ºC
Taħżinx f’ temperatura aktar minn 30ºC
What Tyverb contains
X’ fih Tyverb
28 The active substance in Tyverb is lapatinib ditosylate monohydrate.
Is- sustanza attiva f’ Tyverb hija lapatinib ditosylate monohydrate.
Each film-coated tablet contains lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib.
Kull pillola miksija b’ rita fiha lapatinib, ekwivalenti għal 250 mg lapatinib.
The other ingredients are: − Microcrystalline cellulose, povidone (K30), sodium starch glycolate (Type A), magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400, polysorbate 80, iron oxide yellow (E172), iron oxide red (E172).
29 Is- sustanzi l- oħra huma: − Microcrystalline cellulose, povidone (K30), sodium starch glycolate (Type A), magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400, polysorbate 80, iron oxide yellow (E172), iron oxide red (E172).
What Tyverb looks like and contents of the pack
Id- Dehra ta ’ Tyverb u l- kontenut tal- pakkett
Tyverb film-coated tablets are oval, biconvex, yellow film-coated, with ‘GS XJG’ marked on one side.
Il- pilloli miksija b’ rita Tyverb huma ovali, konvessi fuq iż- żewġ naħat, sofor miksijin b’ rita b ’ ‘ GS XJG ’ immarkata fuq naħa waħda.
Each pack of Tyverb contains 70 tablets in aluminium foil blisters of 10 tablets each.
Kull pakkett Tyverb fih 70 pillola f’ folji ta ’ l- aluminju ta ’ 10 pilloli l- waħda.
Each foil has a perforation down the middle to allow the blisters to be separated into a daily dose of 5 tablets.
Kull folja fiha toqob minn naħa s’ oħra biex l- folja tkun tista ’ tinqata ’ f’ doża ta ’ 5 pilloli kuljum.
Tyverb is also available in multipacks containing 140 tablets that comprise 2 packs, each containing 70 tablets.
Tyverb jinstab ukoll f’ pakketti multipli li fihom 140 pillola magħmulin minn żewġ pakketti, li kull wieħed minnhom fih 70 pillola.
Not all pack sizes may be marketed.
Jista jkun li mhux il- pakketti tad- daqsijiet kollha jkunu ghall- skop kummerċjali.
Marketing Authorisation Holder Glaxo Group Ltd, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom.
Id- Detentur ta ’ l- Aworizzazzjoni għat- tqegħid fis- Suq Glaxo Group Ltd, Berkeley Avenue, Greenford, Middlesex UB6 0NN, Ir- Renju Unit.
Manufacturer Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG 12 0DJ, United Kingdom.
Manifattur Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG 12 0DJ, Ir- Renju Unit.
The European Medicines Agency (EMEA) will review new information on the medicine every year and this leaflet will be updated as necessary.
L- Aġenzija Ewropeja dwar il- Mediċini (EMEA) ser tirrevedi l- informazzjoni l- ġdida dwar il- mediċina kull sena u dan il- fuljett ser jiġi aġġornat skond il- bżonn. >
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
31 Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
The Marketing Authorisation Holder (MAH) shall ensure that, at launch, all healthcare professionals who are experienced to prescribe/ use Valdoxan are provided with educational materials containing the following:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq (MAH) irid jassigura li, mat- tqiegħid fis- suq, il- professjonisti kollha tal- kura tas- saħħa li huma esperjenzati biex jippreskrivu/ jużaw Valdoxan ikunu provduti b’ materjal edukattiv li jkun fih dan li ġej:
EPAR summary for the public
VALDOXAN Sommarju ta ’ l- EPAR għall- pubbliku
What is Valdoxan?
X’ inhu Valdoxan?
Valdoxan is a medicine that contains the active substance agomelatine.
Valdoxan huwa mediċina li fiha s- sustanza attiva agomelatine.
What is Valdoxan used for?
Għal xiex jintuża Valdoxan?
Valdoxan is used to treat major depression in adults.
Valdoxan jintuża biex jikkura dipressjoni maġġuri fl- adulti.
How is Valdoxan used?
Kif jintuża Valdoxan?
The recommended dose of Valdoxan is one tablet once a day, taken at bedtime with or without food.
Id- doża rakkomandata ta ’ Valdoxan hija ta ’ pillola waħda darba kuljum, li tittieħed qabel l- irqad mal - ikel jew fuq xejn.
Because a benefit of Valdoxan has not been shown clearly in patients aged over 65 years, it should be used with caution in this age group.
Minħabba li ma ntwera l- ebda benefiċċju b’ mod ċar ta ’ Valdoxan f’ pazjenti li għandhom aktar minn 65 sena, Valdoxan għandu jintuża b’ mod kawt f’ dan il- grupp ta ’ età.
How does Valdoxan work?
Kif jaħdem Valdoxan?
The active substance in Valdoxan, agomelatine, is an antidepressant.
Is- sustanza attiva f’ Valdoxan, agomelatine, hija antidipressant.
Valdoxan might also help to normalise the patient ’ s sleep patterns.
Valdoxan jista ’ wkoll jgħin ireġġa ’ għan - normal l- istili tal- irqad tal- pazjent.
How has Valdoxan been studied?
Kif ġie studjat Valdoxan?
The effects of Valdoxan were first tested in experimental models before being studied in humans.
L- effetti ta ’ Valdoxan għall- ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq il - bniedem.
Valdoxan has been compared with placebo (a dummy treatment) in five main short-term studies involving a total of 1,893 adults with major depression.
Valdoxan tqabbel ma ’ plaċebo (kura finta) f’ ħames studji ewlenin fuq medda qasira ta ’ żmien li kienu jinvolvu total ta ’ 1, 893 adult b’ dipressjoni maġġuri.
The company also presented the results of a further study comparing Valdoxan with sertraline (another antidepressant).
Il - kumpanija ppreżentat ukoll ir- riżultati ta ’ studju ieħor li qabbel Valdoxan ma ’ sertraline (antidipressant ieħor).
Two other main studies compared the ability of Valdoxan and placebo to prevent symptoms returning in 706 patients whose depression had already been controlled with Valdoxan.
Żewġ studji ewlenin oħra qabblu l- kapaċità ta ’ Valdoxan u plaċebo li jipprevjeni r- ritorn tas- sintomi f’ 706 pazjenti li d- dipressjoni tagħhom kienet diġà ġiet ikkontrollata b’ Valdoxan.
What benefit has Valdoxan shown during the studies?
Liema benefiċċju wera Valdoxan waqt l- istudji mwettqa?
In the short-term studies, Valdoxan was seen to be more effective than placebo in the two studies where no active comparator was used.
Fl- istudji fuq perjodu ta ’ żmien qasir, Valdoxan irriżulta aktar effettiv mill- plaċebo fiż- żewġ studji li fihom ma ntuża l- ebda komparatur attiv.
In the other three studies, which did include an active comparator, there were no differences in scores between the patients taking Valdoxan and those taking placebo.
Fit- tliet studji l- oħra, li ma kinux jinkludu komparatur attiv, ma kien hemm l- ebda differenza fil- punti bejn il- pazjenti li ħadu Valdoxan u dawk li ħadu plaċebo.
In the first of the long-term studies, there was no difference between Valdoxan and placebo in preventing symptoms returning during 26 weeks of treatment.
Fl- ewwel wieħed mill- istudji fuq perjodu ta ’ żmien twil, ma kien hemm l- ebda differenza bejn Valdoxan u plaċebo fil- prevenzjoni tar- ritorn tas- sintomi matul 26 ġimgħa ta ’ kura.
However, the second study showed that symptoms returned in 21% of the patients taking Valdoxan over 24 weeks (34 out of 165), compared with 41% of the patients taking placebo (72 out of 174).
Madankollu, it - tieni studju wera li s- sintomi reġgħu feġġew f’ 21% tal- pazjenti li kienu qed jieħdu Valdoxan fuq 24 ġimgħa (34 minn 165), meta mqabbla ma ’ 41% tal- pazjenti li kienu qed jieħdu plaċebo (72 minn 174).
What is the risk associated with Valdoxan?
X’ inhu r- riskju assoċjat ma ’ Valdoxan?
The most common side effects with Valdoxan (seen in between 1 and 10 patients in 100) are headache, dizziness, somnolence (sleepiness), insomnia (difficulty sleeping), migraine, nausea (feeling sick), diarrhoea, constipation, upper abdominal pain (tummy ache), hyperhidrosis (excessive sweating), back pain, fatigue (tiredness), increases in liver enzymes and anxiety.
L- iktar effetti sekondarji komuni b’ Valdoxan (li dehru f’ bejn pazjent 1 u 10 minn kull 100) huma wġigħ ta ’ ras, sturdament, sonnolenza (ngħas), insonnja (diffikultà biex wieħed jorqod), emikranja, nawżea (dardir), dijarrea, stitikezza, uġigħ fin- naħa ta ’ fuq tal- addome (uġigħ ta ’ żaqq), iperidrożi (għaraq eċċessiv), uġigħ fid- dahar, għeja kbira, żidiet fl- enzimi tal- fwied u ansjetà.
Some of these side effects may be linked to the patient’ s depression rather than Valdoxan itself.
Xi wħud minn dawn l- effetti sekondarji jistgħu jkunu relatati mad- dipressjoni tal- pazjent aktar milli ma ’ Valdoxan innifsu.
For the full list of all side effects reported with Valdoxan, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji kollha rrappurtati b’ Valdoxan, ara l - Fuljett ta ’ Tagħrif.
Valdoxan should not be used in people who may be hypersensitive (allergic) to agomelatine or any of the other ingredients.
Valdoxan m’ għandux jintuża f’ nies li huma ipersensittivi (allerġiċi) għal agomelatine jew għal xi sustanza oħra tiegħu.
It must also not be used in patients who are taking medicines that slow down the breakdown of Valdoxan in the body, such as fluvoxamine (another antidepressant) and ciprofloxacin (an antibiotic).
M’ għandux jintuża wkoll f’ pazjenti li qed jieħdu mediċini li jdewmu l- assorbiment ta ’ Valdoxan fil- ġisem, bħalma huma fluvoxamine (antidepressant ieħor) u ciprofloxacin (antibijotiku).
Valdoxan should not be used in elderly patients with dementia.
Valdoxan m’ għandux jintuża f’ pazjenti anzjani li jbatu bid- dimenzja.
Why has Valdoxan been approved?
Għaliex ġie approvat Valdoxan?
The Committee for Medicinal Products for Human Use (CHMP) noted that Valdoxan’ s benefits in terms of treating depression might be lower than seen with other antidepressants.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) innota li l- benefiċċji ta ’ Valdoxan fir- rigward tal- kura tad- dipressjoni, jistgħu jkunu inqas minn dawk ta ’ antidipressanti oħra.
However, since the medicine has a new mode of action, few side effects and a different safety profile to existing antidepressants, the Committee concluded that Valdoxan could be a valuable treatment for some patients as long as their liver function is tested frequently.
Madankollu, minħabba li l- mediċina għandha mod ġdid ta ’ azzjoni, ftit effetti sekondarji u profil ta ’ sigurtà differenti minn antidipressanti oħra li jeżistu, il- Kumitat wasal għall- konklużjoni li Valdoxan jista ’ jkun kura siewja għal xi pazjenti diment li l- funzjoni tal- fwied tagħhom tiġi ttestjata spiss.
Therefore, the CHMP decided that Valdoxan’ s benefits are greater than its risks for the treatment of major depressive episodes in adults.
Għaldaqstant, is- CHMP iddeċieda li l- benefiċċji ta ’ Valdoxan huma ikbar mir- riskji tiegħu għall- kura ta ’ episodji ta ’ dipressjoni maġġuri fl- adulti.
The Committee recommended that Valdoxan be given marketing authorisation.
Il- Kumitat irrakkomanda li Valdoxan jingħata awtorizzazzjoni għat- tqegħid fis- suq.
2/ 3 Which measures are being taken to ensure the safe use of Valdoxan?
2/ 3 Liema miżuri qed jittieħdu sabiex jiġi assigurat użu sigur għal Valdoxan?
The company that makes Valdoxan will supply educational material for prescribers of Valdoxan when it is launched.
Il- kumpanija li tipproduċi Valdoxan sejra tipprovdi materjal edukattiv lil dawk li jippreskrivu Valdoxan meta dan jitqiegħed fis- suq.
Other information about Valdoxan:
Informazzjoni oħra dwar Valdoxan:
The European Commission granted a marketing authorisation valid throughout the European Union for Valdoxan to Les Laboratoires Servier on 19 February 2009.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Valdoxan lil Les Laboratoires Servier fil- 19 Frar 2009.
The full EPAR for Valdoxan can be found here.
L- EPAR sħiħ għal Valdoxan jista ’ jiġi kkonsultat hawn.
EU Procedure number
Numru ta ’ Proċedura ta ’ l- EU
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita
Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC) Blister (alu/ PVC)
Folja (alu/ PVC) Folja (alu/ PVC) Folja (alu/ PVC) Folja (alu/ PVC) Folja (alu/ PVC) Folja (alu/ PVC) Folja (alu/ PVC) Folja (alu/ PVC)
7 tablets 14 tablets 28 tablets 42 tablets 56 tablets 84 tablets 98 tablets 100 tablets
7 pilloli 14 pilloli 28 pilloli 42 pilloli 56 pilloli 84 pilloli 98 pilloli 100 pilloli
Valdoxan 25 mg film-coated tablets
Valdoxan 25 mg pilloli miksija b’ rita
Valdoxan tablets may be taken with or without food.
Il- pilloli Valdoxan jistgħu jittieħdu ma ’ l- ikel jew mingħajru.
Valdoxan is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy (see section 4.4).
(ara sezzjoni 4. 4)
Only limited clinical data is available on the use of Valdoxan in elderly patients ≥ 65 years old with major depressive episodes.
L- informazzjoni klinika hija limitata dwar l- użu ta ’ Valdoxan f’ pazjenti anzjani ≥ 65 sena b’ episodji maġġuri dipressivi.
Therefore, caution should be exercised when prescribing Valdoxan to these patients (see section 4.4).
(ara sezzjoni 4. 4).
However, only limited clinical data on the use of Valdoxan in depressed patients with severe or moderate renal impairment with major depressive episodes is available.
Madankollu, l- informazzjoni klinika hija limitata dwar l- użu ta ’ Valdoxan f’ pazjenti b’ dipressjoni li jbagħtu minn disturbi fil- kliewi serji jew moderati.
Therefore, caution should be exercised when prescribing Valdoxan to these patients.
Għalhekk, għandha tingħatha attenzjoni meta Valdoxan jiġi preskritt lil dawn il- pazjenti.
2 Valdoxan is contraindicated in patients with hepatic impairment (see sections 4.3, 4.4 and 5.2).
Valdoxan huwa kontra- indikat f’ pazjenti b’ disturbi fil- fwied (ara sezzjonijiet 4. 3, 4. 4 u 5. 2).
Valdoxan is not recommended in the treatment of depression in patients under 18 years of age since safety and efficacy of Valdoxan have not been established in this age group.
Valdoxan mhux rakkomandat għall- kura ta ’ dipressjoni f’ pazjenti ta ’ taħt it- 18 – il sena minħabba li s - sigurta` u l- effikaċja ta ’ Valdoxan mhumiex stabbiliti f’ dan il- grupp.
Valdoxan should not be used for the treatment of major depressive episodes in elderly patients with dementia since the safety and efficacy of Valdoxan have not been established in these patients.
Valdoxan ma jistax jintuża għall- kura ta ’ episodji dipressivi maġġuri f’ pazjenti anzjani bid- dimenzja minħabba li s- sigurta` u l- effikaċja ta ’ Valdoxan ma ġewx stabbiliti f’ dawn il- pazjenti.
Valdoxan should be used with caution in patients with a history of mania or hypomania and should be discontinued if a patient develops manic symptoms.
Valdoxan għandu jintuża b’ attenzjoni f’ pazjenti li għandhom storja ta ’ manija jew ipomanija u għandu jiġi imwaqqaf jekk il- pazjent jiżviluppa sintomi manijaċi.
Caution should be exercised when prescribing Valdoxan with moderate CYP1A2 inhibitors (e. g. propranolol, grepafloxacine, enoxacine) which may result in increased exposure of agomelatine.
Kawtela għandha tittieħed meta jiġi preskriv Valdoxan ma ’ impedituri moderati CYP1A2 (e. z propranolol, grepafloxacine, enoxacine) li jista` jirrizulta f’ zieda ta ’ esponiment t’ agomelatine.
In clinical studies, elevations of serum transaminases (> 3 times the upper limit of the normal range) have been observed in patients treated with Valdoxan particularly on a 50 mg dose (see section 4.8).
Fi studji kliniċi, żidiet fil- livell tas- serum transaminasi (> 3 darbiet mill- għola limitu tal- livell normali) ġew osservati f’ pazjenti b’ Valdoxan b’ mod partikolari b ’ 50 mg (ara sezzjoni 4. 8).
When Valdoxan was discontinued in these patients, the serum transaminases usually returned to normal levels.
Meta Valdoxan kien imwaqqaf f’ dawn il- pazjenti, is- serum transaminasi normalment irritorna għal- livellijiet normali.
The decision whether to continue the patient on therapy with Valdoxan should be guided by clinical judgement pending laboratory evaluations.
Id- deċiżjoni jekk il- pazjent ikomplix fuq il- kura b’ Valdoxan għandha tiġi ggwidata b’ ġudizzju kliniku sakemm isiru testijiet fil- laboratorju.
Caution should be exercised when Valdoxan is administered to patients who consume substantial quantities of alcohol or who are treated with medicinal products associated with risk of hepatic injury.
Kawtela għandha tingħata lil dawk il- pazjenti li jikkonsmaw kwantitajiet sostanzjali ta ’ alkoħol jew li huma kkurati bi prodotti mediċinali b’ riskju ta ’ ħsara fil- fwied meta tingħata kura b’ Valdoxan.
Valdoxan contains lactose.
Valdoxan fih il- lactose.
Consequently, co-administration of Valdoxan with potent CYP1A2 inhibitors (e. g. fluvoxamine, ciprofloxacin) is contraindicated.
Għalhekk, l- użu ta ’ Valdoxan ma ’ impedituri CYP1A2 (eż. fluvoxamine, ciprofloxacin) huwa kontra - indikat.
No evidence of pharmacokinetic or pharmacodynamic interaction with medicinal products which could be prescribed concomitantly with Valdoxan in the target population was found in phase I clinical trials: benzodiazepines, lithium, paroxetine, fluconazole and theophylline.
Ma nstabet l- ebda evidenza ta ’ interazzjoni farmakokinetika jew farmakodinamika ma ’ prodotti mediċinali li jistgħu jiġu preskritti flimkien ma ’ Valdoxan fil- popolazzjoni immirata fi provi kliniċi f’ fażi 1: benzodiazepines, lithium, paroxetine, fluconazole u theophylline.
The combination of Valdoxan and alcohol is not advisable.
Valdoxan ma ’ l- alkoħol mhuwiex rakkomandat.
Therefore, clinical consequences of ECT concomitant treatment with Valdoxan are considered to be unlikely.
Għalhekk, konsegwenzi kliniċi ta ’ kura bl- ECT flimkien mal- kura b’ Valdoxan x’ aktarx ma jseħħux.
If treatment with Valdoxan is considered necessary, breastfeeding should be discontinued.
Jekk il- kura b’ Valdoxan hija kkonsidrata neċessarja, it- treddigħ għandu jiġi mwaqqaf.
In clinical trials, over 3,900 depressed patients have received Valdoxan.
Fi studji kliniċi, iktar minn 3900 pazjent b’ dipressjoni irċevew Valdoxan.
It is therefore sometimes difficult to ascertain which symptoms are a result of the illness itself and which are a result of treatment with Valdoxan.
Għalhekk ikun diffiċli xi kultant biex taċċerta liema sintomi huma riżultat tal- marda nfisha u liema huma riżultat tal - kura b’ Valdoxan.
In humans, Valdoxan has positive phase shifting properties; it induces a phase advance of sleep, body temperature decline and melatonin onset.
Fil- bnedmin Valdoxan għandu propjetajiet posittivi fil- fażi li jinbidel minn ħin għall- ieħor; jinduċi fażi avvanzata ta ’ l- irqad, tnaqqis fit- temperaturi, u bidu ta ’ melatonin.
The efficacy and safety of Valdoxan in major depressive episodes have been studied in a clinical programme including 5,800 patients of whom 3,900 were treated with Valdoxan.
L- effikaċja u s- sigurta` ta ’ Valdoxan f’ episodji dipressivi maġġuri ġew studjati fi programm kliniku li jinkludi 5800 pazjent li minnhom 3900 kienu kkurati b’ Valdoxan.
Six placebo controlled trials have been performed to investigate the short term efficacy of Valdoxan in major depressive disorder: two flexible dose studies and four fixed dose studies.
Sitt provi ikkontrollati bi plaċebo saru biex jinvestigaw l- effikaċja f’ perjodu qasir ta ’ żmien ta ’ Valdoxan b’ diżordni dipressiva maġġuri: żewġ studji b’ doża flessibli u erbgħa b’ doża fissa.
Response rates were statistically significantly higher with Valdoxan compared with placebo.
Il- livell tar- rispons b’ Valdoxan kien statistikament sinifikanti ogħla meta mqabbel ma ’ plaċebo.
Patients responding to 8/ 10-weeks of acute treatment with open-label Valdoxan 25-50 mg once daily were randomised to either Valdoxan 25-50 mg once daily or placebo for further 6-months.
Pazjenti li rrispondew għal kura akuta ta ’ 8/ 10 ġimgħat b ’ Valdoxan open- label 25- 50 mg darba kuljum kienu randomizzati għal għal jew Valdoxan 25- 50 mg darba kuljum jew plaċebo għal 6 xhur oħra.
Valdoxan 25- 50 mg once daily demonstrated a statistically significant superiority compared to placebo (p=0.0001) on the primary outcome measure, the prevention of depressive relapse, as measured by time to relapse.
L- inċidenza li l- marda
The incidence of relapse during the 6-months double-blind follow up period was 22% and 47% for Valdoxan and placebo, respectively.
6 terġa titfaċċa waqt is- 6 xhur segwiti double- blind kienet 22% u 47% għal Valdoxan u plaċebo, rispettivament.
Valdoxan does not alter daytime vigilance and memory in healthy volunteers.
Valdoxan ma jbiddilx l- attenzjoni ta ’ matul l- jum u l- memorja f’ voluntiera b’ saħħithom.
In depressed patients, treatment with Valdoxan 25 mg increased slow wave sleep without modification of REM (Rapid Eye Movement) sleep amount or REM latency.
F’ pazjenti bid- dipressjoni il- kura b’ Valdoxan 25 mg żiedet l- irqad mewġa bil- mod mingħar ma immodifikat l - ammont ta ’ l- irqad REM (Moviment mgħaġġel ta ’ l- għajnejn) jew il- perjodu ta ’ l- REM moħbi.
Valdoxan 25 mg also induced an advance of the time of sleep onset and of minimum heart rate.
Valdoxan 25 mg ukoll wassal għal avvanz fi- żmien għall- bidu ta ’ l- irqad u fir- rata minima tat- taħbit tal- qalb.
6 In a specific sexual dysfunction comparative study with remitted depressed patients, there was a numerical trend (not statistically significant) towards less sexual emergent dysfunction than venlafaxine for Sex Effects Scale (SEXFX) drive arousal or orgasm scores on Valdoxan.
Fi studju komparattiv speċifiku fuq disfunzjoni sesswali f’ pazjenti li ma baqgħux ibgħatu bid - dipressjoni, kien hemm trend numerikali (mhux statistikament sinifikanti) lejn inqas disfunzjoni sesswali b’ Valdoxan minn b’ venlafaxine għall- impulsi sesswali u orgażmi imkejla b’ punti miksuba fl - Iskala ta ’ l- Effetti Sesswali (SEXFX).
The pooled analysis of studies using the Arizona Sexual Experience Scale (ASEX) showed that Valdoxan was not associated with sexual dysfunction.
Ġabra ta ’ studji analizzati permezz ta ’ Iskala Sesswali Arizona (ASEX) urew li Valdoxan ma kienx assoċjat ma ’ disfunzjoni sesswali.
In healthy volunteers Valdoxan preserved sexual function in comparison with paroxetine.
F’ voluntiera b’ saħħithom Valdoxan żamm il- funzjoni sesswali meta mqabbel ma ’ paroxetine.
Valdoxan had neutral effect on body weight, heart rate and blood pressure in clinical studies.
Valdoxan kellu effett newtrali fuq il- piż tal- ġisem, ir- rata tal- qalb u l- pressjoni tad- demm fi studji kliniċi.
In a study designed to assess discontinuation symptoms by the Discontinuation Emergent Signs and Symptoms (DESS) check-list in patients with remitted depression, Valdoxan did not induce discontinuation syndrome after abrupt treatment cessation.
Fi studju mfassal apposta biex ikejjel is- sintomi ta ’ diskontinwazzjoni permezz ta ’ Lista ta ’ Sinjali li joħorġu mad- Diskontinwazzjoni (DESS) f’ pazjenti li ma baqgħux ibagħtu bid- dipressjoni, Valdoxan ma wassalx għal xi sindromu ta ’ diskontinwazzjoni wara li l- kura twaqqfet f’ daqqa.
Valdoxan has no abuse potential as measured in healthy volunteer studies on a specific visual analogue scale or the Addiction Research Center Inventory (ARCI) 49 check-list.
Valdoxan ma weriex xi abbuż potenzjali meta mkejjel fi studji fuq voluntiera b’ saħħithom fuq skala analogu viżwali speċifika jew fid - 49 lista ta ’ l- Inventarju taċ- Ċentru tar- Riċerka fuq id- Dipendenza (ARCI).
Les Laboratoires Servier 22, rue Garnier F-92200 Neuilly-sur-Seine France
Les Laboratoires Servier 22, rue Garnier F- 92200 Neuilly- sur- Seine Franza
Les Laboratoires Servier Industrie, 905, route de Saran - 45520 Gidy, France Servier (Ireland) Industries Ltd, Gorey Road - Arklow - Co.
Les Laboratoires Servier Industrie, 905, route de Saran - 45520 Gidy, Franza Servier (Ireland) Industries Ltd, Gorey Road - Arklow - Co.
Wicklow, Ireland Przedsiebiorstwo Farmaceutyczne ANPHARM S. A., ul.
Wicklow, L - Irlanda Przedsiebiorstwo Farmaceutyczne ANPHARM S. A., ul.
Annopol 6B - 03-236 Warszawa, Poland
Annopol 6B - 03- 236 Warszawa, Il - Polonja
The Marketing Authorisation Holder (MAH) shall ensure that, at launch, all healthcare professionals who are experienced to prescribe/ use Valdoxan are provided with educational materials containing the following:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq (MAH) irid jassigura li, ma ’ l- illoncjar, il- professjonisti kollha tal- kura tas- saħħa li huma esperjenzati biex jippreskrivu/ jużaw Valdoxan ikunu provduti b’ materjal edukattiv li jkun fih dan li ġej:
Valdoxan 25 mg film-coated tablets Agomelatine
Valdoxan 25 mg pilloli miksija b’ rita Agomelatine
Les Laboratoires Servier 22, rue Garnier F-92200 Neuilly-sur-Seine France
Les Laboratoires Servier 22, Rue Garnier F- 92200 Neuilly- sur- Seine Franza
Valdoxan 25 mg tablets Agomelatine
Valdoxan 25 mg pilloli Agomelatine
What Valdoxan is and what it is used for 2.
X’ inhu Valdoxan u għalxiex jintuża 2.
Before you take Valdoxan 3.
Qabel ma tieħu Valdoxan 3.
How to take Valdoxan 4.
Kif għandek tieħu Valdoxan 4.
Possible side effects 5 How to store Valdoxan 6.
Effetti sekondarji li jista ’ jkollu 5.
Further information
Kif taħżen Valdoxan 6.
WHAT VALDOXAN IS AND WHAT IT IS USED FOR
X’ INHU X U GĦALXIEX JINTUŻA
Valdoxan belongs to a group of medicines called antidepressants and you have been given Valdoxan to treat your depression.
Int ġejt mogħti Valdoxan biex tikkura d- dipressjoni tiegħek.
BEFORE YOU TAKE VALDOXAN
QABEL MA TIEĦU VALDOXAN
Do not take Valdoxan
Tieħux Valdoxan
- if you are allergic (hypersensitive) to agomelatine or any of the other ingredients of Valdoxan (see
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal agomelatine jew sustanzi oħra ta ’
‘ What Valdoxan contains ’ in section 6).
Valdoxan (ara ‘ X’ fih Valdoxan ’ f’ sezzjoni 6)
Take special care with Valdoxan There could be some reasons why Valdoxan may not be suitable for you:
Oqgħod attent ħafna b’ Valdoxan Jista ’ jkun hemm xi raġunijiet għala Valdoxan ma jkunx jaqbel miegħek:
Some patients may get increased levels of liver enzymes in their blood during treatment with Valdoxan.
Xi pazjenti jista jkollhom żidiet fil- livelli ta ’ l- enzimi tal- fwied fid- demm waqt il- kura b’ Valdoxan.
Based on the evaluation of these tests the doctor will decide whether you should continue using Valdoxan or not (see also under “ How to take Valdoxan ” in section 3).
Ibbazata fuq l- evalwazzjoni ta ’ dawn it- testijiet it- tabib jiddeċidi jekk inti tkomplix tuża Valdoxan jew le (ara ukoll taħt ‘ Kif tieħu Valdoxan ’ f’ sezzjoni 3).
safe for you to take Valdoxan.
tiegħek meta tieħu Valdoxan.
Valdoxan is not intended for use in children and adolescents (under 18 years old).
Valdoxan mhuwiew maħsub għall- użu fit- tfal u adoloxxenti (ta ’ taħt it - 18 – il sena).