qanastek/EMEA-V3 huggingface dataset:
53%) in patients.
Eliminazzjoni Porfimer sodium jitneħħa bil- mod mill- ġisem b’ rata medja CLT ta ’ 0. 859 ml/ h/ kg (CV 53%) f’ pazjenti.
The serum decay was bi-exponential, with a slow distribution phase and a very long elimination phase that started approximately 24 hours after injection.
It- tnaqqis fis- serum kien bi- esponenzjali, b’ fażi ta ’ distribuzzjoni u fażi twila ħafna u fażi ta ’ eliminazzjoni twila ħafna li tkun bdiet madwar 24 siegħa wara l- injezzjoni.
Special populations The influence of renal and hepatic impairment on exposure to porfimer sodium has not been evaluated (see sections 4.2, 4.3 and 4.4).
Popolazzjonijiet speċifiċi L- influwenza ta’ l- indeboliment tal- kliewi u tal- fwied fuq l- espożizzjoni ta ’ porfimer sodium ma ġiex mistħarreġ (ara sezzjonijiet 4. 2, 4. 3 u 4. 4).
Gender had no effect on pharmacokinetic parameters except for tmax, which was approximately 1.5 hours in women and 0.17 hours in men.
Il- ġeneru ma kellux effett fuq il- fatturi farmakokinetiċi, minbarra tmax, li kellha valur ta ’ 1. 5 sigħat fin - nisa u 0. 17 sigħat fl- irġiel.
This difference may have been due to the sensitivity of the assay used.
Din id- differenza segħtet kienet minħabba s- sensittività tal- metodu użat.
Reproductive toxicology studies were insufficient to support the safety of porfimer sodium during pregnancy, as no light activation had been used.
25 Studji tossikoloġiċi fuq is- sistema riproduttiva ma kienux biżżejjed biex jassiguraw is- sikurezza ta ’ porfimer sodium waqt it- tqala.
Preclinical studies indicate that the excretion of PhotoBarr components occurs primarily via the faecal route
Studji ta ’ qabel l- użu kliniku jindikaw li l- eliminazzjoni prinċipali ta ’ porfimer sodium issir prinċipalment fl- ippurgar.
After reconstitution: use immediately (within 3 hours).
Wara li jiġi rikostitwit: użu minnufih (fi żmien 3 sigħat).
Do not use after the expiry date stated on the carton and vial after the EXP.
M’ għandekx tuża wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- kunjett wara JIS.
75 mg powder in a vial (glass type I, 40 ml capacity) with a grey butyl stopper.
75 mg trab f’ kunjetti (ħġieġ tip I, jesa ’ 40 ml) b’ tapp griż tal- butyl.
Instructions for reconstitution PhotoBarr 75 mg vial should be reconstituted with 31.8 ml of 5% glucose solution for injection, resulting in a final porfimer sodium concentration of 2.5 mg/ ml in the solution for injection.
Rikostituzzjoni Il- kunjett ta ’ 75 mg ta ’ PhotoBarr għandu jiġi rikostitwit b’ 31. 8 ml ta ’ 5% glucoseta ’ infużjoni intravenuża, għal konċentrazzjoni finali ta ’ 2. 5 mg/ ml ta ’ porfimer sodium għal soluzzjoni għall - injezzjoni.
Do not use other diluents.
26 Tużax dilwenti oħrajn.
Sufficient vials of PhotoBarr should be reconstituted to provide the patient with a dose of 2 mg/ kg.
Għandhom jitlestew biżżejjed fjali ta ’ PhotoBarr sabiex jipprovdu l- pazjent b' doża ta ’ 2 mg/ kg bil - kalkulazzjoni ta ’ hawn isfel.
Spills and disposal Spills of PhotoBarr should be wiped up with a damp cloth.
Titjir u rimi Kull titjir ta ’ PhotoBarr għandu jintmesaħ b’ biċċa niedja.
26 PhotoBarr is for single use only and any unused solution should be discarded.
PhotoBarr huwa għal użu ta ’ darba biss u kull soluzzjoni mhux użata għandha tintrema.
Engelenkampstraat 72 NL-6131JJ Sittard The Netherlands
Engelenkampstraat 72 NL- 6131JJ Sittard l- Olanda
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT >
28 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR (I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Route de Bû 78550 Houdan France
Route de Bû 78550 Houdan Franza
The MAH shall agree the details of educational materials with the National Competent Authorities to ensure that all health care professionals who intend to prescribe and/ or dispense PhotoBarr are provided with the following: • Prescriber guide • Prescriber slide kit • Healthcare professionals administration and monitoring guide • Patient alert card • Patient guide
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jiftiehem dwar il- materjal edukattiv mal- Awtoritajiet Kompetenti Nazzjonali sabiex jiżgura li l- professjonisti kollha tal- kura tas- saħħa li għandhom ħsieb jippreskrivu u/ jew iqassmu PhotoBarr jiġu provduti b’ dan li ġej: • Gwida għal min jikteb ir- riċetti • Kitt ta ’ slides għal min jikteb ir- riċetti • Gwida dwar l- għoti u l- monitoraġġ mill- professjonisti tal- kura tas- saħħa • Kard ta ’ alert lil pazjent • Gwida tal- pazjent
Caution should be exercised if patients have moderate hepatic disease
Pazjenti M’ GĦANDHOMX jiu trattati b’ porfimer jekk: o ikollhom mard tal- fwied sever o għandhom fistli fit- trakea jew bronki- esofaġeali o ikollhom tmermir suspettat tal- vażi tad- demm ewlenin.
−
− -
Before initiating therapy, o The patient should be screened for skin type o Patients should be aware of the long half-life of porfimer and that the compound gets activated by light. o Patients should avoid being exposed to light for 60-90 days post-exposure. o all patients should know that UV blocking is not effective in blocking visible light which activates porfimer. o Patients should be aware of potential risk factors (skin phototype and hepatic impairment). o Patients should be instructed to seek medical advice if signs/symptoms suggestive of photosensitivity occur during or after therapy with porfimer.
Kawtela għandha tiġi eżerċitata jekk il- pazjenti ikollhom mard tal- fwied moderat Qabel tinbeda t- terapija, o Il- pazjent għandu jiġi skrinjat għat- tip ta ’ ġilda o Il- pazjenti għandhom ikunu konxji dwar il- half- life twil ta ’ porfimer u li l- kompost jiġi attivat bid- dawl. o Pazjenti għandhom jevitaw li jiġu esposti għad- dawl għal 60- 90 jum wara l- espożizzjoni o Il- pazjenti kollha għandhom ikunu jafu li imblokk bl- UV mhux effettiv biex jimblokka d- dawl viżibbli li jattiva porfimer
29
29 Pazjenti għandhom ikunu konxji dwar fatturi ta ’ riskju potenzjali o (fototip tal- ġilda u indeboliment epatiku).
It is important to follow exactly the correct steps for reconstitution and administration of porfimer.
Huwa importanti li ssegwi eżattament l- istadji korretti għar- rikostituzzjoni u l- għoti ta ’ porfimer.
It is important to have an appropriate light dose and a proper setting for the laser.
Huwa importanti li tingħata d- doża xierqa ta ’ dawl u kontroll xieraq għal- laser.
Healthcare professionals should be aware of side effects that may arise during or shortly after treatment, and how to treat them.
Professjonisti tal- kura tas- saħħa għandhom ikunu konxji dwar effetti kollaterali waqt u ftit wara t- trattament, u kif wieħed għandu jitratthom.
Patients should be warned of the possibility of long term side effects, especially photosensitivity, and the need to seek medical assistance if they arise.
Pazjenti għandhom jingħataw twissija dwar il- possibilità ta ’ effetti kollaterali fuq tul ta ’ żmien, speċjalment fotosensittività, u l- bżonn ta ’ assistenza medika jekk ikun hemm bżonn.
Record the patient’s skin type and the date of injection on the patient alert card
Irreġistra t- tip ta ’ ġilda tal- pazjent u d- data tal- injezzjoni fuq il- kard ta ’ alert tal- pazjent.
You should not be treated with PhotoBarr if you have severe liver disease (eg cirrhosis)
M’ għandekx tiġi trattat b’ PhotoBarr jekk għandek mard tal- fwied sever (eż. cirrosi)
You should be screened for skin type Area in card for physician to record skin type and date of injection.
Għandek tiġi skrinjat għat- tip ta ’ ġilda Hemm post fuq il- kard għat- tabib biex jirrikordja t- tip ta ’ ġilda u d- data tal - injezzjoni.
Patient guide − Brief background and introduction to Barrett’s oesophagus and high grade dysplasia − What photodynamic therapy is − Patients should inform their doctor before they start treatment if they have severe hepatic disease. − That PhotoBarr o Remains in your body for 60-90 days after receiving the injection o Is activated by visible light o There is an increased risk of photosensitivity (sensitivity to light) o Exposed skin will become red and cause discomfort in most cases but severe cases of photosensitivity are possible o Commercially available sun blocks are not effective in preventing sensitivity due to light − Photosensitivity can only be prevented by avoiding exposure to the sun for 90 days after receiving the PhotoBarr injection − It is important that patients tell their doctor if they get exposed to sunlight after receiving treatment with PhotoBarr. − There are a number of potential side effects that patients should be aware of.
Li PhotoBarr o Jibqa ’ fil- ġisem tiegħek għal 60- 90 jum wara li tirċievi l- injezzjoni o Jiġi attivat bid- dawl viżibbli o Hemm riskju ogħla ta ’ fotosensittività (sensittività għad- dawl) o Il- ġilda esposta ser issir ħamra u tikkawża skonfort f’ ħafna każijiet imma każijiet severi ta ’ fotosensittività huma possibbli o Sun blocks kummerċjalment disponibbli m’ humiex effettivi biex jevitaw is- sensittività minħabba d- dawl.
30 Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2 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 ’ Ġestjoni dwar ir- Riskju Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jimpenja ruħu li jwettaq studju ta ’ reġistru u attivitajiet ta ’ farmakoviġilanza, skond il- Pjan ta ’ Farmakoviġilanza, kif miftehem fil- verżjoni 2 tal- Pjan ta ’ Ġestjoni dwar ir- Riskju (RMP) preżentata f’ Modulu 1. 8. 2 tal- Applikazzjoni tal- Awtorizzazzjoni għat- Tqegħid fis- Suq u kull aġġornament sussegwenti tal- RMP miftiehem mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products of human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida ta ’ CHMP dwar Sistemi ta ’ Ġestjoni dwar ir- Riskju għal prodotti mediċinali li jintużaw mill- bniedem, RMP aġġornat għandu jiġi sottomess fl- istess ħin tar - Rapport ta ’ Aġġornament Perijodiku dwar is- Sigurtà (PSUR).
In addition, an updated RMP should be submitted:
Barra minn hekk, RMP aġġornat għandu jiġi sottomess:
− When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities − Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached − At the request of the EMEA
− Meta jasal tagħrif ġdid li jista ’ jkollu impatt fuq l- Ispeċifikazzjoni dwar is- Sigiurtà attwali, il- Pjan ta ’ Farmakoviġilanza u attivitajiet li jnaqqsu r- riskju − Fi żmien 60 jum li jintlaħaq tragward importanti (farmakoviġilanza dwar minimizzazzjoni ta ’ riskju) Fuq talba tal- EMEA
31 ANNEX III
31 ANNESS III
Carton - 15 mg
Kartuna 15 mg
PhotoBarr 15 mg powder for solution for injection Porfimer sodium
PhotoBarr 15 mg trab għal soluzzjoni għall- injezzjoni Porfimer sodium
One vial contains 15 mg porfimer sodium.
Kull kunjett fih 15 mg trab ta ’ porfimer sodium.
After reconstitution, each ml solution contains 2.5 mg porfimer sodium.
Wara rikostituzzjoni, kull ml fih 2. 5 mg porfimer sodium
Hydrochloric acid, sodium hydroxide (for pH adjustment).
Hydrochloric acid, sodium hydroxide (għal aġġustament ta ’ pH).
Intravenous use Read the package leaflet before use.
Għal użu ġol- vina Aqra l- fuljett li jinsab fil- pakkett qabel l- użu.
After reconstitution, protect from light and use within 3 hours.
Żomm il- kunjett fil- kartuna ta ’ barra sabiex tilqa mid- dawl Wara li tirrikostitwixxi, ipproteġi mid- dawl uża fi żmien 3 sigħat.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 34 Axcan Pharma International B.V.
34 BŻONN.
Engelenkampstraat 72 6131JJ Sittard The Netherlands
Engelenkampstraat 72 NL- 6131JJ Sittard l- Olanda
Vial 15 mg - 7 ml
Kunjett ta ’ 15 mg - 7 ml
PhotoBarr 15 mg powder for solution for injection Porfimer sodium Intravenous use
PhotoBarr 15 mg trab għal soluzzjoni għall- injezzjoni Porfimer sodium Jittieħed minn ġol- vina
Read the package leaflet before use.
Aqra l- fuljett li jinsab fil- pakkett qabel l- użu.
Carton – 75 mg
Kartuna - 75 mg
PhotoBarr 75 mg powder for solution for injection Porfimer sodium
PhotoBarr 75 mg trab għal soluzzjoni għall- injezzjoni Porfimer sodium
One vial contains 75 mg porfimer sodium After reconstitution, each ml solution contains 2.5 mg porfimer sodium.
Wara rikostituzzjoni, kull ml ta ’ soluzzjoni fih 2. 5 mg porfimer sodium.
Powder for solution for injection.1 vial
Trab għal soluzzjoni għall- injezzjoni.
Keep the vial in the outer carton in order to protect from light After reconstitution, protect from light and use immediately within 3 hours.
Żomm il- fjala fil- kartuna ta ’ barra sabiex tilqa mid- dawl Wara r- rikostituzzjoni, ipproteġi mid- dawl u uża minnufih fi żmien 3 sigħat.
37 Engelenkampstraat 72 6131JJ Sittard The Netherlands
Engelenkampstraat 72 NL- 6131JJ Sittard l- Olanda
38 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
38 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Vial 75 mg - 40 ml
Kunjett 75 mg - 40 ml
PhotoBarr 75 mg powder for solution for injection Porfimer sodium Intravenous use
PhotoBarr 75 mg trab għal soluzzjoni għall- injezzjoni Porfimer sodium Jittieħed minn ġol- vina
40 PACKAGE LEAFLET:
40 FULJETT TA ’ TAGĦRIF:
You may need to read it again
Jista ’ jkollok bżonn terġa taqrah.
What PhotoBarr is and what it is used for 2.
X’ inhu PhotoBarr u għalxiex jintuża 2.
Before you use PhotoBarr 3.
Qabel ma tuża PhotoBarr 3.
How to use PhotoBarr 4.
Kif għandek tuża PhotoBarr 4.
Possible side effects 5 How to store PhotoBarr 6.
Kif taħżen PhotoBarr 6.
WHAT PHOTOBARR IS AND WHAT IT IS USED FOR
X’ INHU PHOTOBARR U GĦALXIEX JINTUŻA
PhotoBarr is a light -activated medicine used in photodynamic therapy (PDT) in combination with a non-burning red laser light.
PhotoBarr hija mediċina attivata bid- dawl f’ terapija fotodinamika (PDT), f ’ kombinazzjoni ma ’ dawl laser aħmar li ma jaħraqx.
PDT specifically targets and destroys abnormal cells.
PDT speċifikament hu mmirat u jeqred ċelluli anormali.
PhotoBarr is used to remove high -grade dysplasia (cells with atypical changes that increase the risk of developing cancer) in patients with Barrett's oesophagus (gullet).
PhotoBarr huwa użat biex ineħħi displasja ta ’ grad għoli (ċelluli b’ bidliet atipiċi li jżidu r- riskju li jiżviluppa l- kanċer) f’ pazjenti li għandhom esofagu ta ’ Barrett.
BEFORE YOU USE PHOTOBARR
QABEL MA TUŻA PHOTOBARR
Do not use PhotoBarr
Tużax PhotoBarr
- if you are allergic (hypersensitive) to porfimer sodium, other porphyrins or any of the other
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal porfimer sodium, jew porfirini oħra
ingredients of PhotoBarr (listed in section 6, ‘What PhotoBarr contains’)
jew sustanza ta ’ PhotoBarr (elenkata f’ sezzjoni 6, ‘ X’ fih PhotoBarr ’)
- if you have porphyria
- jekk għandek porfirja
- if you have an opening (fistula) between the oesophagus and the airways
- jekk għandek ftuħ (fistula) bejn l- esofagu u l- passaġġi tan- nifs
- if you suffer from varices of your oesophageal veins or erosion of other major blood vessels
- jekk tbati minn variċi għal vini tal- esofagu jew tgħawwir ta ’ vażi tad- demm maġġuri
- if you have ulcers in your oesophagus
- jekk għandek ulċeri ta ’ daqs partikolari fl- esofagu tiegħek
- if you have severe liver or kidney problems
- jekk għandek problemi severi fil- funzjoni tal- fwied jew tal- kliewi
Take special care with PhotoBarr Tell your doctor if any of the following applies to you:
Oqgħod attent ħafna b’ PhotoBarr Għid lit- tabib tiegħek jekk dan li ġej japplika għalik:
- you are taking any other medicines (see below),
- jekk qed tieħu mediċini oħrajn (ara isfel)
- you have a liver or kidney problems
- jekk hemm problemi bil- fwied jew bil- kliewi
- you have a family history of cataracts
- jekk hemm storja fil- familja ta ’ kataretti
- you are 75 years or older,
- jekk għandek 75 sena jew aktar
- you have or have had heart or lung disease
- jekk għandek jew kellek problemi kardijaċi serji jew mard pulmonari.
PhotoBarr should not be used in children and adolescents below 18 years of age, due to lack of experience.
PhotoBarr m’ għandux jintuża fi tfal u adoloxxenti li għandhom inqas minn 18- il sena, minħabba nuqqas ta ’ esperjenza
41 Tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
41 Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Some other medicines may increase the risk for photosensitivity reactions for example antibiotics or antidiabetic medicines.
Xi mediċini jistgu jgħollu r- riskju ta ’ reazzjonijiet ta ’ fotosensittività pereżempju, antibijotiċi u/ jew prodotti tad- dijabete.
Using PhotoBarr with food and drink The laser light application will induce difficulties with swallowing (pain, nausea and vomiting).
Meta tieħu PhotoBarr mal- ikel u x- xorb L- applikazzjoni tad- dawl laser ser toħloq diffikultajiet biex tibla ’ (uġigħ, tqalligħ u remettar).
Therefore, you should take liquid food only for a few days (in some cases up to 4 weeks).
Għalhekk, għandek tieħu ikel likwidu għal ftit jiem (f’ xi każijiet għal 4 ġimgħat).
If eating or drinking becomes impossible or if you keep vomiting, please return to the clinical for medical attention.
Jekk it- teħid tal- ikel jew ix- xorb isir impossibbli jew jekk tibqa ’ tirremetti, jekk jogħbok irritorna lura fil- klinika għal attenzjoni medika
Pregnancy and breast-feeding PhotoBarr should not be used during pregnancy unless clearly necessary.
Tqala u treddigħ PhotoBarr m’ għandux jintuża waqt it- tqala kemm- il darba mhux daqshekk meħtieġ.
Women of childbearing age should take adequate contraceptive precautions whilst and up to 90 days after receiving PhotoBarr.
Nisa li huma ta ’ età li jista t- tfal għandhom jieħdu prekawzjonijiet xierqa waqt li qed jingħataw PhotoBarr u sa 90 jum wara li tkun irċevejt PhotoBarr.
You should stop breast-feeding before using PhotoBarr.
Għandek tieqaf tredda ’ qabel tibda tuża PhotoBarr.
During your light treatment you may receive sedation.
Waqt it- trattament tiegħek bid- dawl għandek mnejn jagħtuk kalmant.
In this case, you should avoid any activities that require mental alertness such as driving a car or using any machine.
F' dan il- każ, għandek tevita kull attività li teħtieġ il- prontezza mentali bħal sewqan ta ’ vettura jew l- użu ta ’ magna
HOW TO USE PHOTOBARR
KIF GĦANDEK TUŻA PHOTOBARR
How does photodynamic therapy (PDT) work?
Kif taħdem it- terapija fotodinamika (PDT)?
One course of PDT consists of one injection of PhotoBarr plus one or two laser light applications.
Kors wieħed ta ’ PDT tikkonsisti minn injezzjoni waħda flimkien ma ’ applikazzjoni waħda jew tnejn ta ’ dawl tal- laser.
To increase your response rate, you may need up to three PDT courses, separated by at least 90 days.
Sabiex tiżdied ir- rata ta ’ rispons tiegħek, għandek mnejn ikollok bżonn tliet korsijiet ta ’ PDT, separati bejniethom b’ 90 jum.
PhotoBarr injection:
Injezzjoni ta ’ PhotoBarr:
You will receive one intravenous injection of PhotoBarr (2 mg per kg of body weight), 40 to 50 hours before laser light treatment.
Għandek tirċievi injezzjoni waħda ġol- vina ta ’ PhotoBarr (2 mg għal kull kg ta ’ piż tal- ġisem) bejn 40 sa 50 siegħa qabel trattament bid- dawl laser.
The reddish-brown solution is slowly injected, over 3 to 5 minutes, into a vein.
Is- soluzzjoni ta ’ lewn kannella fl- aħmar tiġi injettata bil- mod ġol- vina fuq perijodu ta ’ bejn 3 sa 5 minuti.
Laser light treatment:
Trattament bid- dawl laser:
Your doctor will apply the red laser light (not a burning laser) to the involved area using an endoscope (a device used to see inside certain parts of the body).
It- tabib tiegħek ser japplika id- dawl laser ħamrani (mhux laser li jaħraq) fiż- żona involuta permezz ta ’ endoskopu (tagħmir li jintuża ġewwa ċertu partijiet tal- ġisem.
You may receive a second laser light treatment 96-120 hours after the initial injection of PhotoBarr.
Għandek mnejn tirċievi trattament ieħor bid- dawl laser 96- 120 siegħa wara l- injezzjoni inizjali ta ’ PhotoBarr.
You will be given a sedative along with a local anaesthetic to minimise discomfort.
Ser tingħata kalmant flimkien ma ’ anestetiku sabiex jitnaqqas l- iskomfort
If you miss the laser light treatment Both the medicine and laser light are necessary for the therapy to work.
Jekk tonqos milli tieħu t- trattament bid- dawl id- dawl laser?
If you realise that you have missed your appointment for the laser treatment, contact your doctor immediately.
Kemm il- mediċina u kemm id- dawl laser huma meħtieġa għat- terapija Jekk tinduna li tlift xi appuntament għat- trattament tal- laser, ikkuntattja lit- tabib tiegħek minnufih.
Your doctor will decide how to proceed with the treatment.
It- tabib tiegħek ser jiddeċiedi kif tipproċedi bit- trattament tiegħek.
They consist mainly of sunburn -like reactions, mild redness on exposed skin, usually the face and hands.
Kif tevita li jkollok reazzjoni fotosensittiva Reazzjonijiet ta ’ fotosensittività huma effetti komuni ħafna ta ’ PhotoBarr (li jaffettwaw aktar minn 2 fi 3 utenti) Dawn jikkonsistu minn reazzjonijiet bħal ħruq mix- xemx, ħmura ħafifa fuq il- ġilda esposta, ġeneralment fil- wiċċ u l- idejn.
For 90 days following your PhotoBarr injection, you must take precautions to avoid exposure of skin and eyes to light.
Għal 90 jum wara l- injezzjoni ta ’ PhotoBarr, għandek tieħu prekawzjonijiet sabiex tevita l- espożizzjoni tal- ġilda u l- għajnejn għad- dawl.
If you have liver problems, this period might be longer.
Jekk għandek problemi tal- fwied, dan il- perijodu jista ’ jkun itwal.
Since PhotoBarr is activated by the red part of light, sunscreens for UV (ultraviolet) light will not protect you against photosensitivity reactions.
Peress li PhotoBarr hu attivat mill- parti l- ħamra tad- dawl, kremi tad- dlik kontra x- xemx għad- dawl UV (ultravjola) mhux ser jipproteġuk kontra reazzjonijiet ta ’ fotosensittività.
Direct sunlight:
Xemx diretta:
42 Before you go to receive your PhotoBarr injection, check that there are adequate shades and curtains in your home to keep out bright sunlight.
42 Qabel ma tmur biex tieħu l- injezzjoni PhotoBarr tiegħek, iċċekja li fid- dar tiegħek hemm biżżejjed lqugħ u purtieri sabiex jilqgħalek għad- dawl qawwi tax- xemx.
If you go out during daylight hours (even on cloudy days and while travelling in a vehicle), you should take the following precautions:
Jekk toħroġ waqt is- sigħat ta ’ dawl tax - xemx (anke f’ jiem bis- sħab u waqt li qed tivvjaġġa f’ karozza) għandek tieħu l- prekawzjonijiet li ġejjin:
- cover as much skin as possible by wearing a long-sleeved shirt, trousers, socks, shoes, gloves
- għatti kemm tista ’ mill- ġilda billi tilbes qmis ta ’ komma twila, qalziet twil, kalzetti, żarbun,
and a wide brimmed hat
ingwanti u kappell bil- falda wiesgħa.
- protect your eyes with dark sunglasses.
- ipproteġi għajnejk billi tilbes nuċċali tax- xemx skur
- remember to take protective clothing and sunglasses with you to your appointment, as you will
- tinsiex tieħu ilbies protettiv u nuċċali tax- xemx miegħek għall- appuntament li jmissek, peress li
be photosensitive once the injection has been given.
int ser tkun fotosensittiv, ġaladarba tingħatalek l- injezzjoni.
Indoor light:
Dawl ta ’ ġewwa:
Avoid direct exposure to bright indoor lights, including dental lamps, operating room lamps, unshaded light bulbs at close proximity or neon lights.
Evita l- espożizzjoni diretta ta ’ dawl luminanti ta ’ ġewwa, li jinkludu l- lampi tad- dentist, lampi li jintużaw għal interventi kiruġiċi, lampi mingħajr lqugħ u li toqgħod qrib ta ’ dawl tan- neon.
However, to speed up the natural process of inactivating the medicine in your body, it is good to expose the skin to normal levels of indoor light.
Madankollu biex tgħaġġel il- proċess naturali sabiex il- mediċina ma tibqax attiva f’ ġismek, huwa tajjeb jekk tesponi l- ġilda għal livelli normali ta ’ dawl ta ’ ġewwa.
You do not need to stay in a darkened room.
M’ għandekx għalfejn tibqa ’ ġo kamra mudlama.
Photosensitivity skin test About 90 days after the PhotoBarr injection, you should test the photosensitivity of your skin as follows:
Test għal fotosensittività tal- ġilda Wara 90 jum mit- teħid tal- injezzjoni PhotoBarr, inti tista ’ tittestja l- ġilda tiegħek kif ġej:
Cut a 2-inch hole in a paper bag, put it on your hand or elbow (not your face).
Aqta ’ toqba ta ’ 2 pulzieri f’ borża tal- karti, agħmilha f’ idejk jew fuq minkbejk (mhux fuq wiċċek).
Expose a small area of skin to sunlight for 10 minutes.
Esponi l- erja żgħira tal- ġilda fid- dawl tax- xemx għal 10 minuti.
Check for the appearance of red marks, swelling or blistering after one day.
Iċċekkja għad dehra ta ’ marki ħomor, nefħa jew nfafet wara jum
- if none of these appear on the exposed area, then you can gradually return to your normal
- jekk ebda wieħed minn dawn ma jidher fl- erja esposta, mela jidher li tista ’ tibda tirritorna għall -
outdoor activities, limiting exposure to the sun during the midday hours.
attivitajiet normali tiegħek, billi tillimita l- espożizzjoni għax- xemx fis- sigħat ta ’ nofsinhar.
- if any of these signs are seen, then continue to protect yourself from bright light for 2 more
- jekk xi wieħed minn dawn is- sinjali qed jidher allura ibqa ’ ipproteġi ruħek mid- dawl illuminanti
weeks, then repeat the skin test.
għal ġimagħtejn oħra, imbagħad erġa ’ irrepeti t- test tal- ġilda.
If you go on holiday to an area with more sunshine, remember to repeat the skin test, especially if some areas of skin have not been exposed to sunlight since your PhotoBarr treatment.
Speċjalment jekk xi partijiet mill- ġilda ma kienux esposti għax- xemx minn meta ħadt it- trattament ta ’ PhotoBarr.
Like all medicines, PhotoBarr can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, PhotoBarr jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
All patients who receive PhotoBarr will be photosensitive (sensitive to light) and must observe precautions to avoid direct sunlight and bright indoor light (see above ‘How to prevent a photosensitivity reaction’).
Kull pazjent li jirċievi PhotoBarr ser ikun fotosensittiv (sensitiv għad- dawl) u għandu jieħu prekawzjonijiet sabiex jevita xemx diretta jew dawl qawwi ġewwa (ara fuq, ‘ Kif tevita reazzjoni fotosensittiva ’).
Tell your doctor immediately:
Għarraf lit- tabib tiegħek minnufih jekk:
- if you notice a change in your eyesight.
- tinduna b’ bidla fil- vista t’ għajnejk.
You should visit your eye specialist.
Għandek iżżur lill- ispeċjalista tal- għajnejn tiegħek.
- if you are not able to swallow at all or repeated vomiting occurs
- jekk ma tistax tibla xejn jew tibqa ’ tirremetti.
Side effects may occur with certain frequencies, which are defined as follows:
Effetti sekondarji jistgu jseħħu b’ ċertu frekwenzi, li huma mfissra kif ġej:
affects more than 1 user in 10 affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000 frequency cannot be estimated from the available data.
li jaffettwaw aktar minn utent 1 f’ kull 10 li jaffettwaw aktar minn 1 sa 10 utenti f’ kull 100 li jaffettwaw aktar minn 1 sa 10 utenti fkull 1, 000 li jaffettwaw aktar minn 1 sa 10 utenti f’ kull 10, 000 li jaffettwaw anqas minn utent 1 f’ kull 10, 000 Frekwenza ma tistax tiġi stabbilita mit- tagħrif disponibbli.
- photosensitivity reactions (see section 3)
- reazzjonijiet ta ’ fotosensittività (ara sezzjoni 3)
- constipation, dehydration
- stitikezza, deidrazzjoni.
- back pain, pain in arms and legs, pain due to treatment
- uġigħ fid- dahar, uġigħ fid- dirgħajn u r- riġlejn,
- headache, feeling nervous, tingling feeling, problems sleeping
- uġigħ ta ’ ras, tħossok nervuż, tnemnim, problemi biex torqod.
- abdominal stiffness, stomach pain, vomiting blood
- ebusija addominali, uġigħ fl- istonku, remettar tad- demm,
- disorders of the gullet such as ulcer, irritation or constriction
- disturb fil- pajp tal- ikel, bħal ulċera, irritazzjoni jew tagħfis
- loose stools, passing dark tarry stool, sore throat, hiccups, belching
- ippurgar maħlul, tgħaddi ppurgar b’ ċapep suwed, uġigħ fil- griżmejn, tnaqqis fl- aptit, sulluzzu,
- fluid in chest, chest pain, fast heart beat, shortness of breath, shakes due to high fever, chills
- fluwidu fis- sider, uġigħ fis- sider, nifs qasir, uġigħ minħabba t- trattament, rogħda minħabba deni
- loss of weight, decrease in appetite, feeling tired, loss of taste
- telf fil- piż, tnaqqis fl- aptit, tħossok għajjien, ma tibqax ittiegħem.
- skin ulcer, rash, itchiness, hives, change in skin colour, scratch, scar, abnormal tissue, bump on
- ulċera fil- ġilda, raxx, ħakk, ħorriqija, bidla fil- kulur tal- ġilda, grif, ġerħa, tessut mhux normali,
the skin, very small cysts in the skin, dry and fragile skin
boċċa fil- ġilda, ċisti żgħar fuq il- ġilda, ġilda xotta u fraġli.
- difficulty breathing, decrease in level of oxygen, choking, swelling of the airways, fluid in
- diffikultà biex tieħu n- nifs, tnaqqis fil- livell ta ’ ossiġenu, tifga, il- passaġġi tal- arja jintefħu,
airways, shortness of breath during physical activity, wheezing, coughing up more phlegm, coughing up blood, stuffy nose
fluwidu fil- passaġġ respiratorju, nifs qasir waqt attività fiżika, tħarħir, sogħla bil- materja, tisogħol id- demm, mnieħer imblukkat.
- lung infection, sinus infection
- Infezzjoni fil- pulmun, infezzjoni fis- sinus
- chest pain or heart attack, high blood pressure or low blood pressure, chest discomfort
- uġigħ fis- sider jew attakk tal- qalb, pressjoni tad- demm għolja jew pressjoni tad- demm baxxa,
- abnormal blood test results, including increase in white blood cells, low potassium levels
- testijiet tad- demm mħux normali, li jinkludu żieda fl- għadd ta ’ ċelluli tad- demm bojod, livelli
- bleeding, loss of blood, increased tendency to bruise
- emorraġija, tendenza ogħla biex titbenġel
- overdevelopment of breasts in men, inability to urinate, temperature intolerance, cold sweats,
- l- iżvilupp żejjed ta ’ sider fl- irġiel, ma tistax tgħaddi awrina, intolleranza għat- temperatura,
night sweats
togħriq fil- kesħa
- general swelling, general pain, musculoskeletal chest pain, stiffness of joint, inflammation of the
- nefħa ġenerali, uġigħ ġenerali, uġigħ fis- sider muskoluskeletriku, ebusija tal- ġog,
heel
infjammazzjoni tal- għarqub
- shakes, restlessness, dizziness, numbness, flushes, feeling weak, feeling unwell
- rogħda, irrikwitezza, tħossok sturdut, tnemnim, fwawar, tħossok debboli, tħossok ma tiflaħx.
- loss of hearing, ringing in the ears, swelling of the eye, eye pain
- telf tas- smigħ, ċenċil fil- widnejn, nefħa fl- għajnejn, uġigħ fl- għajnejn.
- rash, redness at the injection site, nail fungal infection, skin infection, blister, itchy skin,
- raxx, ħmura fis- sit tal- injezzjoni, infezzjoni fungali fid- dwiefer, infezzjoni tal- ġilda, infafet,
overgrowth of tissue at the site of skin injury, scar pain, scab, presence of skin moles, abnormal hair growth
ħakk fuq il- ġilda, uġigħ minn ġerħa, il- preżenza ta ’ tbajja ’ fuq il- ġilda, xagħar jikber mhux normali.
HOW TO STORE PHOTOBARR
KIF TAĦŻEN PHOTOBARR
Do not use PhotoBarr after the expiry date which is stated on the carton and vial after EXP.
M’ għandekx tuża PhotoBarr wara d- data li jiskadi li tidher fuq il- kartuna u l- kunjett wara JIS.
Do not store above 25°C.
Taħżinx f’ temperatura 'l fuq minn 25 °C.
After reconstitution, PhotoBarr solution should be protected from light and used immediately (within 3 hours).
Wara li jkun ġie rikostitwit, PhotoBarr għandu jiġi mħares mid- dawl u għandu jintuża minnufih (fi żmien 3 sigħat)..
44 What PhotoBarr contains
44 X’ fih PhotoBarr:
- The active substance is porfimer sodium.
Is- sustanza attiva hi porfimer sodium.
After
Kull kunjett fih 15 mg ta ’ porfimer sodium.
reconstitution, each ml solution contains 2.5 mg porfimer sodium.
Wara r - rikostituzzjoni kull ml fih 2. 5 ml porfimer sodium.
- The other ingredients are hydrochloric acid and sodium hydroxide (for pH adjustment).
Is- sustanzi l- ohra huma hydrochloric acid u/ jew sodium hydroxide (għal aġġustament ta ’ pH).
What PhotoBarr looks like and contents of the pack PhotoBarr is a reddish brown powder for solution for injection.
Porfimer sodium hija soluzzjoni għall- injezzjoni ta ’ lewn kannella fl- aħmar.
One single-use vial per pack.
Il- prodott jiġi fornut għal użu ta ’ darba biss.
Marketing Authorisation Holder Axcan Pharma International B.V., Engelenkampstraat 72, NL -6131JJ Sittard, The Netherlands
Axcan Pharma International B. V., Engelenkampstraat 72, NL- 6131JJ Sittard, l- Olanda
Manufacturer Axcan Pharma S.A., Route de Bû, 78550 Houdan, France
Axcan Pharma S. A., Route de Bû, 78550 Houdan, Franza
For any information about this medicine, please contact the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
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
You may need to read it again
Jista ’ jkollok bżonn terġa taqrah
PhotoBarr is a light -activated medicine used photodynamic therapy (PDT)in combination with a non-burning, red laser light.
PhotoBarr hija mediċina attivata bid- dawl f’ terapija fotodinamika (PDT), f ’ kombinazzjoni ma ’ dawl laser aħmar li ma jaħraqx.
- if you are allergic (hypersensitive) to porfimer sodium other porphyrins or to any other
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal porfimer sodium, jew porfirini oħra
ingredients of PhotoBarr (listed in section 6 “What PhotoBarr contains”)
ta ’ PhotoBarr (elenkata f’ sezzjoni 6, ‘ X’ fih PhotoBarr ’)
- if you have severe liver of kidney problems
- jekk għandek problemi severi fil- funzjoni tal- fwied jew tal- kliewi
- you have liver or kidney problems
- jekk hemm problemi bil- fwied jew bil- kliewi
- you have a family history of cataracts,
- jekk hemm storja fil- familja ta ’ kataretti
- have or have had heart or lung disease
- jekk għandek jew kellek problemi kardijaċi serji jew mard pulmonari.
46 Tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
46 Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Some other medicines may increase the risk for photosensitivity reactions for example antibiotics or antidiabetic medicines.
Xi mediċini jistgħu jgħollu r- riskju ta ’ reazzjonijiet ta ’ fotosensittività pereżempju, antibijotiċi u/ jew prodotti tad- dijabete.
No studies on the effects on the ability to drive and use machines have been performed.
Sewqan u tħaddim ta ’ magni Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
In this case, you should avoid any activity that requires mental alertness such as driving a car or using any machine.
F' dan il- każ, għandek kull attività li teħtieġ il- prontezza mentali bħal sewqan ta ’ vettura jew l- użu ta ’ magna.
You will receive one intravenous injection of PhotoBarr (2 mg per kg of body weight) 40 to 50 hours before laser light treatment.
Għandek tirċievi injezzjoni waħda ġol- vina ta ’ PhotoBarr (2 mg għal kull kg ta ’ piż tal- ġisem) bejn 40 sa 50 siegħa qabel trattament bid- dawl laser.
Your doctor will apply the red laser light(not a burning laser) to the involved area using an endoscope (a device used to see inside certain parts of the body)..
It- tabib tiegħek ser japplika id- dawl laser laser ħamrani (mhux laser li jaħraq) fiż- żona involuta permezz ta ’ endoskopu (tagħmir li jintuża ġewwa ertu partijiet tal- ġisem.
You will be given a sedative along with a local anaesthetic, to minimise discomfort
Ser tingħata kalmant flimkien ma ’ anestetiku sabiex jitnaqqas l- skomfort.
47 Before you go to receive your PhotoBarr injection, check that there are adequate shades and curtains in your home to keep out bright sunlight.
Qabel ma tmur biex tieħu l- injezzjoni PhotoBarr tiegħek, iċċekja li fid- dar tiegħek hemm biżżejjed lqugħ u purtieri sabiex jilqgħalek għad- dawl qawwi tax- xemx.
Avoid direct exposure to bright indoor lights, including dental lamps, operating room lamps, unshaded light bulbs at close proximity or neon lights.
Dawl ta ’ ġewwa: Evita l- espożizzjoni diretta ta ’ dawl luminanti ta ’ ġewwa, li jinkludu l- lampi tad - dentist, lampi li jintużaw għal interventi kiruġiċi, lampi mingħajr lqugħ u li toqgħod qrib ta ’ dawl tan - neon.
You should visit your eye specialist.
Għandekiżżur lill- ispeċjalista tal- għajnejn tiegħek.
- tightening of the gullet (oesophagus), difficulty in swallowing that may cause pain
- għafis fl- esofagu, diffikultà biex tibla li jista ’ jikkawża l- uġigħ,
- bleeding, loss of blood, increased tendency to bruise
- emorragija, tendenza ogħla biex titbenġel
- over development of breasts in men, inability to urinate, temperature intolerance, cold sweats,
- l- iżvilupp żejjed ta ’ sider fl- irġiel, ma tistax tgħaddi awrina, intolleranza għat- temperatura,
- shakes, restlessness, dizziness, numbness, flushes, feeling weak, feeling unwell
infjammazzjoni tal- għarqub
- loss of hearing, ringing in the ears, swelling of the eye, eye pain
- rogħda, irrikwitezza, tħossok sturdut, tnemnim, fwawar, tħossok debboli, tħossok ma tiflaħx.
- rash, redness at the injection site, nail fungal infection, skin infection, blister, itchy skin,
- telf tas- smigħ, ċenċil fil- widnejn, nefħa fl- għajnejn, uġigħ fl- għajnejn.
overgrowth of tissue at the site of skin injury, scar pain, scab, presence of skin moles, abnormal hair growth
raxx, ħmura fis- sit tal- injezzjoni, infezzjoni fungali fid- dwiefer, infezzjoni tal- ġilda, infafet, ħakk fuq il- ġilda, uġigħ minn ġerħa, il- preżenza ta ’ tbajja ’ fuq il- ġilda, xagħar jikber mhux normali.
After reconstitution, PhotoBarr solution should be protected from light and used immediately (within 3 hours).
Wara li jkun ġie rikostitwit, PhotoBarr għandu jiġi mħares mid- dawl u għandu jintuża minnufih (fi żmien 3 sigħat).
Chemical and physical in -use stability has been demonstrated for 3 hours at 23°C.
Stabbilità kimika u fiżika tal- prodott għall- użu ġiet murija għal 3 sigħat f ’ temperatura ta ’ 23°C.
If not used immediately, in-use storage time and conditions prior to use are the responsibility of the user.
Jekk ma ’ jintużax minnufih, il- ħażna tiegħu għall- użu u kundizzjonijiet qabel l- użu huma r- responsabbiltà tal- utent.
FURTHER INFORMATION
X’ fih PhotoBarr:
49 What PhotoBarr contains
49
After
Kull kunjett fih 75 mg ta ’ porfimer sodium.
- reconstitution, each ml solution contains 2.5 mg porfimer sodium.
Wara r - rikostituzzjoni kull ml fih 2. 5 ml porfimer sodium
The other ingredients are hydrochloric acid and/or sodium hydroxide (for pH adjustment).
Is- sustanzi l- oħra huma hydrochloric acid u/ jew sodium hydroxide (għal aġġustament ta ’ pH).
What PhotoBarr looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett
PhotoBarr is a reddish brown powder for solution for injection.
Porfimer sodium hija soluzzjoni għall- injezzjoni ta ’ lewn kannella fl- aħmar..
Marketing Authorisation Holder:
Il- prodott jiġi fornut għal użu ta ’ darba biss.
Axcan Pharma International B.V., Engelenkampstraat 72, NL-6131JJ Sittard, The Netherlands
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq Axcan Pharma International B. V., Engelenkampstraat 72, NL- 6131JJ Sittard, l- Olanda
Axcan Pharma S.A., Route de Bû, 78550 Houdan, France
Axcan Pharma S. A., Route de Bû, 78550 Houdan, Franza
50 ANNEX IV
50 ANNESS IV
51 GROUNDS FOR ONE ADDITIONAL RENEWAL
51 BAŻI GĦAL TIĠDID ADDIZZJONALI WIEĦED
Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit-risk balance of PhotoBarr remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Skont it- tagħrif disponibbli minn meta ngħatat l- Awtorizzazzjoni għat- Tqegħod fis- Suq inizjali, is- CHMP jikkonsidra li l- bilanċ dwar il- benefiċċju/ riskju ta ’ PhotoBarr għadu pożittiv, imma jikkonsidra li l- profil tas- sigurtà għandu jibqa ’ jiġi monitorat mill- qrib minħabba r- raġunijiet li ġejjin:
− Several follow-up measures in terms of clinical trials aiming to address several identified risks of PhotoBarr (i.e. prevention of photosensitivity, oesophageal stenosis and oesophageal perforation) are still ongoing: two clinical trials (PHOEST07-01 and PHOTB05-01) have been initiated only recently. − In addition and further to the ongoing status of these clinical trials, the CHMP considered that there was a need to have a risk management plan for this medicinal product, including education materials as risk minimisation activities in order to lower identified and potential risks related to the use of this medicinal product.
− Diversi miżuri ta ’ follow- up f’ termini ta ’ provi kliniċi bil- għan li jindirizzaw diversi riskji identifikati għal PhotoBarr (i. e. prevenzjoni ta ’ fotosensittività, stenosi esofageali u perforazzjoni esofageali) għadhom għaddejjin: żewġ provi kliniċi (PHOEST07- 01 u PHOTB05- 01) ġew mibdija biss riċentement. − Barra minn hekk u lil hinn mill- istat għaddej ta ’ dawn il- provi kliniċi, is- CHMP ikkonsidra li kien meħtieġ pjan ta ’ ġestjoni għal dan il- prodott mediċinali, li jinkludi materjal edukattiv għal attivitajiet li jiminimizzaw r- riskju sabiex jitnaqqsu r- riskji identifikati u potenzjali relatati mal- użu ta ’ dan il- prodott mediċinali.
Therefore, based upon the safety profile of PhotoBarr, the CHMP concluded that the MAH should submit one additional renewal application in 5 years time.
Għalhekk, skont il- profil tas- sigurtà ta ’ PhotoBarr, is- CHMP ikkonkluda li l- MAH għandu jissottometti applikazzjoni ta ’ tiġdid addizzjonali fi żmien 5 snin.
What is Plavix?
X’ inhu Plavix?
Plavix are pink tablets.
Plavix huma pilloli roża.
Plavix contains the active ingredient clopidogrel (75 mg).
Plavix fih l- ingredjent attiv clopidogrel (75 mg).
What is Plavix used for?
Għal x’ hiex jintuża Plavix?
Plavix is used in adult patients to prevent atherothrombotic events (problems caused by blood clots and hardening of arteries).
Plavix jintuża f’ pazjenti adulti biex jipprevjeni episodji aterotrombotiċi (problemi kkawżati minn għoqiedi tad- demm u ebusija ta ’ l- arterji).
Plavix can be given to: • patients who have recently had a myocardial infarction (heart attack); Plavix can be started in the few days after the attack and up to 35 days later, • patients who have had a recent ischaemic stroke (non-bleeding stroke); Plavix can be started in the 7 days after the attack and up to 6 months later, • patients with peripheral arterial disease (problem with blood flow in the arteries), • patients who have a condition known as acute coronary syndrome, when it should be given with aspirin (another anticoagulant), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up).
Plavix jista ’ jingħata lil: • pazjenti li jkun għadu kemm tahom attakk tal- qalb; Plavix jista ’ jinbeda fl- ewwel ftit jiem wara l- attakk u sa 35 jum wara, • pazjenti li riċentament tkun tathom puplesija iskemika (puplesija li ma tkunx seħħet minħabba ħruġ ta ’ demm; Plavix jista ’ jinbeda fis- sebat ijiem ta ’ wara l- attakk u sa sitt xhur wara, • pazjenti b’ mard fl- arterji periferali (problemi bil- mixi tad- demm fl- arterji), • pazjenti b’ kundizzjoni magħrufa bħala sindromu koronarju akut, meta jingħata ma ’ l- aspirina (antikoagulant ieħor), fosthom f’ pazjenti li tkun iddaħħlitilhom stent (tubu qasir imqiegħed f’ arterja biex ma jħallihiex tingħalaq).
Plavix can be used in patients who are having a heart attack with an ‘ ST segment elevation’ (an abnormal reading on the electrocardiogram or ECG) when the doctor thinks that they would benefit from the treatment.
Plavix jista ’ jintuża f’ pazjenti li jkollhom attakk tal - qalb flimkien ma ’ ‘ elevazzjoni fit- taqsima ST ’ (riżultat mhux normali ta ’ l - elettrokardjogramma jew ECG) meta t- tabib jaħseb li jkunu se jibbenefikaw mit- trattament.
It can also be used in patients who do not have this abnormal reading on the ECG, if they have unstable angina (a severe type of chest pain) or have had a ‘ non-Q-wave’ myocardial infarction.
Jista ’ jintuża wkoll f’ pazjenti li ma jkollhomx din l- abnormalità fl- ECG, jekk ikollhom anġina instabbli (uġigħ sever fis- sider) jew li jkollhom attakk tal- qalb ‘ mhux tal- mewġa Q ’ (‘ non- Q - wave ’).
How is Plavix used?
Kif jintuża Plavix?
Plavix should be given as a single daily dose of 75 mg (one tablet) with or without food.
Plavix għandu jingħata bħala doża waħdanija ta ’ 75 mg (pillola waħda) ma ’ jew mingħajr l- ikel.
In acute coronary syndrome, Plavix is used together with aspirin and the treatment generally starts with a 300 mg loading dose, which is followed by a daily dose of 75 mg for at least 4 weeks in ST elevation myocardial infarction or for up to 12 months in non-ST elevation syndrome.
Fis - sindromu koronarju akut, Plavix jintuża ma ’ l- aspirina u t- trattament ġeneralment jibda b’ doża waħdanija ta ’ 300 mg, segwita minn doża ta ’ kuljum ta ’ 75 mg għal ta ’ l- inqas 4 ġimgħat f’ pazjenti li jkun tahom attakk tal- qalb akkumpanjat minn elevazzjoni tat- taqsima ST ta ’ l- ECG għal ta ’ l- inqas 4 ġimgħat jew għal mhux iktar minn 12- il xahar f’ pazjenti bis- sindromu li fih ma tkunx elevata t - taqsima ST.
How does Plavix work?
Kif jaħdem Plavix?
Plavix is an inhibitor of platelet aggregation.
Plavix hu inibitur ta ’ l- aggregazzjoni tal- platelets.
This means that it helps to prevent blood clots from forming.
Dan ifisser li jgħin fil- prevenzjoni ta ’ l- għaqid tad - demm.
When the blood clots, this is due to special cells in the blood, the platelets, sticking together (aggregating).
Meta d- demm jagħqad, dan iseħħ minħabba li ċelloli speċjali fid- demm, il- platelets, jeħlu ma ’ xulxin (aggregating).
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Clopidogrel, is- sustanza attiva fi Plavix, iwaqqaf il- platelets milli jeħlu ma ’ 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged becoming ‘ sticky’.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged xulxin billi jimblokka sustanza, ADP, milli tingħaqad ma ’ riċettur speċjali fuq il- wiċċ tagħhom.
This reduces the risk of a blood clot forming and helps prevent another heart attack or stroke.
Dan iwaqqaf lill- platelets milli jsiru ‘ jwaħħlu ’.
How has Plavix been studied?
Kif ġie studjat Plavix?
The effectiveness of Plavix as an anticoagulant was examined in a study (CAPRIE) of around 19,000 patients with atherothrombosis, where Plavix was compared with aspirin.
L- efikaċja ta ’ Plavix bħala antikoagulant ġiet eżaminata fi studju (CAPRIE) li fih ħadu sehem madwar 19, 000 pazjent b’ aterotrombożi, fejn Plavix tqabbel ma ’ l- aspirina.
Neither the patient nor the doctor knew what medicine the patient was receiving.
La l- pazjent u lanqas it- tabib ma kien jaf liema mediċina kien qed jingħata l- pazjent.
The study lasted from one to three years, and examined the rate of new ischaemic events (heart attacks, ischaemic strokes and death).
L- istudju dam bejn sena u tliet snin, u eżamina r - rata ta ’ episodji iskemiċi ġodda (attakki tal- qalb, puplesiji iskemiċi u mewt).
In non-ST elevation acute coronary syndrome, Plavix was compared to a placebo (a dummy treatment) in over 12,000 patients for up to one year (CURE study):
Fis- sindromu koronarju akut mhux akkumpanjat minn elevazzjoni fit- taqsima ST, Plavix tqabbel ma ’ plaċebo (trattament finta) f’ iktar minn 12, 000 pazjent għal mhux iktar minn sena (l- istudju CURE):