qanastek/EMEA-V3 huggingface dataset:
Weight decreased, body temperature increased Blood albumin decreased, blood chloride increased, blood urea increased, haematocrit decreased, haemoglobin decreased, oxygen saturation decreased, protein total decreased
Telf fil- piż, żieda fit- temperatura tal- ġisem Tnaqqis fil- livelli tal- albumina fid- demm, żieda fil- livelli ta ’ klorur fid- demm, żieda fil- livelli ta ’ urea fid- demm, tnaqqis fil- livelli tal- ematokrit, tnaqqis fil - livelli tal- emoglobina, tnaqqis fil- livelli tas- saturazzjoni tal- ossiġnu, tnaqqis fil - livelli tal- proteini totali
9 Injury poisoning, and procedural complications Common:
Korriment, avvelenament u komplikazzjonijiet ta ’ xi proċedura Komuni:
Post procedural pain, abrasion Blister, post procedural haemorrhage
Nuffat, emorraġija post- proċedurali
Of the serious adverse events (SAEs) in the PhotoBarr PDT + OM group, 44 (23.1%) were considered associated with the treatment.
44 suġġett (23. 1%) tal- grupp PhotoBarr PDT + OM kellhom reazzjonijiet avversi serji li ġew assoċjati mat- trattament.
The most frequently reported treatment-associated serious adverse reaction (SAR) was dehydration (4%), experienced by 5 patients.
Minn dawn, l- aktar komuni kienu deidratazzjoni (4%), li effettwat 5 pazjenti.
The majority of the SARs were gastrointestinal disorders (8% - 11 patients), specifically nausea (3% - 4 patients), vomiting (3% - 4 patients) and upper abdominal pain (2% - 2 patients).
Fil- biċċa l- kbira, r- reazzjonijiet avversi li kienu serji li effettwaw ħdax il- pazjent, kienu problemi fis- sistema diġestiva (8%), b’ mod speċifiku d- dardir (3% - 4 pazjenti), rimettar (3% - 4 pazjenti), u uġigħ fin- naħa ta ’ fuq tal- addome (2% - 2 pazjenti).
The majority of treatment-associated oesophageal stenosis (which includes oesophageal narrowing and oesophageal strictures) reported in the PhotoBarr PDT + OM group were of mild or moderate intensity (92%).
Fil- biċċa l- kbira ta ’ trattamenti assoċjati ma ’ stenożi tal- esofagu (li jinkludu tidjiq u konrtazzjonijiet fl - esofagu) li ġew rapportati fil- grupp ta ’ PhotoBarr PDT + OM, kienu ta ’ natura hafifa jew moderata (92%).
All incidences of strictures were considered associated with treatment of which 1% was considered serious.
L- inċidenzi kollha ta ’ kontrazzjonijiet ġew ikkunsidrati li kienu assoċjati mat- trattament, li minnhom 1% kienu ta ’ natura serja.
An occurrence rate of 12% for oesophageal strictures was observed during the first course of treatment.
Fl- ewwel kors tat- trattament ġiet osservata rata ta ’ 12% ta ’ kontrazzjonijiet fl- esofagu.
The occurrence rate rose to 32% when a second course of therapy was given, especially in the areas where second treatment overlaps the first and amounted to 10% for those who received a third treatment course.
Dawk li ħadu t- tielet trattament kellhom rata ta’ 10%.
The majority of these was mild to moderate in intensity and could be managed through 1-2 dilatations.
Fil- biċċa l- kbira, l - gravità kienet minn ħafifa sa moderata, u l- problema ġiet milgħuba wara 1- 2 trattamenti ta ’ twessigħ.
Eight percent were severe, requiring multiple (6 - > 10) dilatations.
Tmienja fil- mija kienu serji hu kellhom bżonn madwar (6 - > 10) trattamenti ta ’ twessigħ.
The formation of oesophageal stenosis cannot be reduced or eliminated by the use of steroids.
Il - formazzjoni ta ’ stenożi fl- esofagu ma tistax tiġi mnaqqsa jew mrażżna permezz tal- isterojdi.
One case of possible precipitation of cataracts has been reported.
Kien hemm każ rapportat li pazjent seta qabdu l- kataretti minħabba t- trattament.
A 51 year-old obese man was treated with PhotoBarr PDT for HGD in BO, off-label.
Raġel oħxon ta ’ 51 sena kien ittrattat b’ terapija fotodinamika, PhotoBarr għal HGD fl- esofagu ta ’ Barrett (mingħajr tikketta)..
PhotoBarr There is no information on overdose of PhotoBarr.
PhotoBarr M’ hemmx informazzjoni fuq każijiet ta ’ doża eċċessiva b’ PhotoBarr.
The recommended 2 mg/ kg dose, instead of the recommended single administration, was given twice two days apart (10 patients) and three times within two weeks (1 patient), without any notable adverse reactions being reported.
Dożi ogħla tal- prodott mediċinali minn dawk rakkomandati ta ’ 2 mg/ kg, ngħataw f’ intervall ta ’ jumejn (f’ 10 pazjenti), u tlett dożi ta ’ 2 mg/ kg, li ngħataw f’ intervall ta ’ ġimagħtejn (f’ pazjent wieħed), kienu tollerati mingħajr reazzjonijiet avversi.
The effects of an overdose on the duration of photosensitivity are unknown.
L- effetti ta ’ doża eċċessiva fuq is- sensittività eċċessiva għad- dawl m’ humiex magħrufa.
Laser treatment should not be given if an overdose of PhotoBarr is administered.
F’ każ ta ’ doża eċċessiva b’ PhotoBarr, m’ għandux ikun hemm trattament bil- laser.
In the event of an overdose, patients should protect their eyes and skin from direct sunlight or bright indoor lights for 90 days.
Pazjenti li jkunu ħadu doża eċċessiva għandhom iħarsu għajnejhom u l- ġilda minn dawl dirett tax- xemx, jew lampi qawwija ta ’ ġewwa għal 90 jum.
At this time, patients should test for residual photosensitivity (see section 4.4).
F’ dan il- perijodu l- pazjenti għandhom jiċċekjaw għal sensittività eċċessiva għad- dawl residwa (ara sezzjoni 4. 4).
Porfimer sodium is not dialyzable.
PhotoBarr ma jitneħħiex b’ dijalisi.
Laser light Light doses of two to three times the recommended dose have been administered to a few patients with superficial endobronchial tumours.
Dawl laser Dożi ta ’ dawl minn darbtejn sa tlett darbiet aktar minn dawk rakkomandati ngħataw lil ftit pazjenti b’ tumuri superfiċjali fil- bronki.
One patient experienced life-threatening dyspnoea and the others had no notable complications.
Pazjent wieħed sofra qtugħ ta ’ nifs letali, filwaqt li l- bqija ma
Increased symptoms and damage to normal tissue might be expected following an overdose of light.
Huwa mistenni li jkun hemm żieda fis- sintomi u ħsara lit- tessut normali meta jkun hemm espożizzjoni eċċessiva għad- dawl.
Sensitizers used in photodynamic/ radiation therapy, ATC code:
Sensitizzaturi użati gal terapija fotodinamika/ radjazzjoni Kodiċi ATC:
Mechanism of action Porfimer sodium is a mixture of porphyrin units, which are linked together in chains of two to eight units The cytotoxic actions of porfimer sodium are light and oxygen-dependent.
L- azzjoni ċitotossika ta ’ porfimer sodium tiddependi fuq dawl u ossiġnu.
Photodynamic therapy with PhotoBarr is a 2-stage process.
Terapija fotodinamika b’ PhotoBarr tikkonsisti f’ żewġ stadji.
The first stage is the intravenous injection of PhotoBarr.
L- ewwel proċess jinvolvi injezzjoni ġol- vina b’ PhotoBarr.
10 Clearance from a variety of tissues occurs over 40-72 hours, but tumours, skin, and organs of the reticuloendothelial system (including liver and spleen) retain porfimer sodium for a longer period.
Ir- rata ta ’ eliminazzjoni ta ’ PhotoBarr minn tessuti diversi tieħu ’ l fuq minn 40 - 72 sigħat, iżda tumuri, ġilda, u l- organi tas- sistema retikulo- endoteljali (li jinkludu l- fwied u l- milsa) iżżommu porfimer sodium għal perjodu itwal.
Illumination of the target area with 630 nm wavelength laser light constitutes the second stage of therapy.
It- tieni parti tat- terapija tinvolvi l- espożizzjoni għad - dawl laser b’ 630 nm wavelength, fuq il- parti li jkollha bżonn it- trattament.
Tumour and dysplastic tissue selectivity in treatment may occur partly through selective retention of porfimer sodium but mainly through a selective delivery of light.
Is- selettività tat- trattament għat- tumur jew għat- tessut displastiku, tista ’ parzjalment tiġri minħabba li dan it- tip ta ’ tessut iżomm aktar porfimer sodium, iżda l- aktar minħabba l- mod ta ’ kif jiġi mwassal id- dawl.
Cellular damage caused by porfimer sodium PDT is a consequence of the propagation of free radical reactions.
Il- ħsara li tiġri liċ - ċelluli minħabba t- terapija fotodinamika PhotoBarr hija konsegwenza tar- reazzjonijiet li jinvolvu radikali liberi.
Radical initiation may occur after porfimer sodium absorbs light to form a porphyrin excited state.
Ir- reazzjonijiet tar- radikali liberi jinbdew wara li porfimer sodium jassorbi d- dawl u b’ hekk porphyrin jifforma stat ta ’ enerġija ogħla.
Spin transfer from porfimer sodium to molecular oxygen may then generate singlet oxygen.
It- trasferiment tal- għażil minn porfimer sodium għal molekuli tal- ossiġnu jipproduċu ossiġnu fi stat waħdani.
Subsequent free radical reactions can form superoxide and hydroxyl radicals.
Sussegwentement reazzjonijiet tar- radikali jipproduċu superoxide u hydroxyl.
Tumour cell death also occurs through ischaemic necrosis secondary to vascular occlusion that appears to be partly mediated by thromboxane A2 release.
Dan hu maħsub li jiġri parzjalment permezz ta ’ thromboxane A2 li jkun disponibbli.
The laser treatment induces a photochemical, not a thermal, effect.
It- trattament bil- laser jikkaġuna effett fotokemikali mhux termali.
The necrotic reaction and associated inflammatory response evolve over several days.
Ir- reazzjoni nekrotika u l - infjammazzjoni assoċjata ma ’ kif il- ġisem jirreaġixxi, jiżviluppaw fuq medda ta ’ diversi jiem.
Clinical efficacy In a controlled clinical trial, a PhotoBarr PDT + OM (omeprazole) patient group (n=183)was compared to a group of patients receiving OM only (n=70).
Effikaċja klinika Fi prova klinika kkontrollata, grupp ta ’ pazjenti li kienu fuq PhotoBarr PDT + OM (n=183) ġew mqabbla ma ’ grupp ta ’ pazjenti li kienu ngħataw OM biss (n=70).
Eligible patients for this study were to have biopsy-proven HGD in Barrett's oesophagus (BO).
Il- pazjenti li kienu eliġibbli f’ dan l - istudju kellhom HGD fl- esofagu ta ’ Barrett (BO) li ġie kkonfermat b’ biopsija.
Patients were excluded from the study if there was a presence of invasive oesophageal cancer, if they had a history of cancer other than non- melanoma skin cancer or if they had received prior PDT to the oesophagus.
Pazjenti li nstabilhom kanċer invażiv fl- esofagu ġew esklużi jekk kellhom storja medika ta ’ kanċer minbarra kanċer tal- ġilda li mhuwiex melanoma, jew jekk ma ħadux trattament qabel ta ’ PDT fl- esofagu.
Other exclusion criteria were patients in whom omeprazole therapy was contraindicated.
Raġunijiet oħrajn biex pazjenti ġew esklużi kienu kontraindikazzjoni għal użu ta ’ terapija b’ omeprazole.
Patients randomised to treatment with PDT received PhotoBarr at a dose of 2 mg/ kg body weight through slow intravenous injection over 3 to 5 minutes.
L- injezzjoni ngħatat fuq bejn 3 sa 5 minuti.
One or 2 laser light treatments were administered following PhotoBarr injection.
Wara l- injezzjoni ta ’ PhotoBarr, il- pazjenti ngħataw trattament jew tnejn bid- dawl laser.
The first laser light session occurred 40-50 hours after injection and a second session, if indicated, occurred 96-120 hours after injection.
L - ewwel sessjoni bid- dawl laser saret 40- 50 siegħa wara l- injezzjoni u tieni sessjoni, jekk dan ġie indikat saret wara 96- 120 siegħa.
Patients randomised to the OM only group received orally omeprazole 20 mg BID for the duration of the study.
L- għoti flimkien ma ’ omerprazole (20 mg BID) beda tal- anqas jumejn qabel l- injezzjoni ta ’ PhotoBarr. Pazjenti li ġew magħżula b’ modd randomised fil- grupp OM, ngħataw mill - ħalq 20 mg omeprazole BID, matul dan l- istudju.
Patients were followed every 3 months until 4 consecutive, quarterly follow-up endoscopic biopsy results were negative for HGD, and then biannually until the last enrolled patient had completed a minimum of 24 months of follow-up evaluations after randomisation.
Il- pazjenti ġew sorveljati kull 3 xhur sakemm ir- riżultati tal- bijopsija u l- endoskopija wrew għal erba ’ darbiet wara xulxin li ma ’ kienx hemm HGD u mbagħad darbtejn f’ sena sakemm l- aar pazjent arwolat kien lesta minimu ta ’ 24 xahar ta ’ evalwazzjonijiet wara randomizzazzjoni.
PhotoBarr PDT + OM was effective in eliminating HGD in patients with BO.
PhotoBarr PDT + OM kien effettiv biex inneħħi HGD f ’ pazjenti b ’ esofagu ta ’ Barrett.
At final analysis, performed at a minimum of 24 months follow-up, a statistically significant percentage of patients (77%) in the PhotoBarr PDT + OM group demonstrated complete HGD ablation compared to 39% of patients in the OM alone group (p < 0.0001).
Il- perċentwal ta ’ pazjenti li tfejqu għal kollox minn HGD kien statistikament sinifikanti (77%) fil- grupp ta ’ PhotoBarr PDT + OM, meta mqabbel ma ’ riżultat miksub ta ’ 39% mill- grupp ta ’ OM biss (p < 0. 0001).
Fifty-two percent of patients in the PDT + OM group showed normal squamous cell epithelium while 59% had absence of dysplasia compared to 7% and 14% in the OM alone group, respectively (p < 0.0001).
52% tal- pazjenti fil- grupp PDT + OM, urew li kellhom iċ- ċelluli tal- epitelju normali, filwaqt li 59% ma kellhomx displasja, meta mqabbla ma ’ 7% u 14% fil- grupp ta ’ OM biss (p < 0. 0001).
These results confirm those observed after a minimum of 6 months follow-up which showed HGD ablation in 72% of patients in the PhotoBarr PDT + OM group compared to 31% in the OM only group.
11 grupp PhotoBarr PDT + OM, meta mqabbla ma ’ 31% fil- grupp OM biss.
Forty-one percent of patients showed normal squamous cell epithelium and 49% had absence of dysplasia.
Wieħed u erbgħin fil mija tal- pazjenti urew li kellhom ċelluli tal- epitelju squamous anormali, filwaqt li 49% ma kellhomx displasja.
By the end of the minimum follow-up of two years, 13% in the PhotoBarr PDT + OM group had progressed to cancer compared to 28% in the OM only group in the intent-to-treat (ITT) population.
Wara mill- anqas sentejn sorveljanza, 13% tal- grupp PhotoBarr PDT + OM, żviluppaw kanċer, meta mqabbla ma ’ 28% fil grupp li użaw OM biss fil- popolazjoni ITT (intent to treat).
The proportion of patients who progressed to cancer in the PhotoBarr PDT + OM group was statistically lower than in the OM only group (p=0.0060).
Il- proporzjon ta ’ pazjenti li żviluppaw kanċer fil- grupp PhotoBarr PDT + OM kien statistikament aktar baxx mill- grupp li użaw OM biss (p=0. 0060).
The survival curves indicated that, by the end of the entire follow-up period, patients in the PhotoBarr PDT + OM group had a 83% chance of being cancer-free as compared to a 53% chance for patients in the OM only group.
Il- kurva ta ’ sopravivenza tindika li matul l- istudju kollhu, pazjenti li kienu fil- grupp PDT + OM kellhom 83% ċans li ma jiżviluppawx kanċer, meta mqabbla ma ’ 53% ċans fil- każ ta ’ pazjenti tal- grupp OM biss.
Comparison between the survival curves of the two treatment arms using the log rank test showed a statistically significant difference between the curves of the two groups in the ITT population (p=0.0014), indicating a significant delay in the progression to cancer.
Din tindika dewmien sinifikanti fl- iżvilupp tal- kanċer.
11 The pharmacokinetics of porfimer sodium have been studied in 12 patients with endobronchial cancer and 23 healthy subjects (11 men and 12 women), given 2 mg/ kg porfimer sodium through slow intravenous injection.
Studju farmakokinetiku sar fuq 12- il pazjent li kellhom kanċer fil- bronki u 23 individwu b’ saħħtu (11 - il rael u 12- il mara) li ngħataw 2 mg/ kg portimer sodium b’ injezzjoni ġol- vina bil- mod.
Plasma samples were obtained out to 56 days (patients) or 36 days (volunteers) post-injection.
Kampjuni tal - plażma ttieħdu sa 56 jum (pazjenti) jew 36 jum (voluntieri) wara l- injezzjoni.
In patients, the mean peak plasma concentration (Cmax) was 79.6 μ g/ ml (CV 61%, range 39-222), whereas in volunteers Cmax was 40 μ g/ ml and AUCinf was 2400 μ g/ h/ ml.
61%, medda ta ’ 39- 222), filwaqt li tal- voluntieri Cmax kien ta ’ 40 μg/ ml u AUCinf kien ta ’ 2400 μg/ ml.
Distribution In vitro binding of porfimer sodium to human serum protein is around 90% and independent of concentration between 20 and 100 μ g/ ml.
Distribuzzjoni Madwar 90% ta ’ porfimer sodium jeħel in vitro ma ’ proteini tas- serum fil- ġisem tal- bniedem, b’ mod indipendenti mill- konċentrazzjoni ta ’ bejn 20 u 100 μg/ ml.
Elimination Porfimer sodium is cleared slowly from the body, with a mean CLT of 0.859 ml/ h/ kg (CV 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.
Ii- taħsir 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.
The mean elimination half-life (t1/ 2) was 21.5 days (CV 26%, range 264-672) in patients and 17 days in volunteers.
Il- half- life ta ’ eliminazzjoni medja (t1/ 2) kienet ta ’ 21. 5 ijiem (CV 26%, medda 264- 672) f’ pazjenti u 17- il jum wara f’ voluntieri.
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 tal- 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.
At the time of intended photoactivation 40-50 hours after injection, the pharmacokinetic profiles of porfimer sodium in men and women were very similar.
Fil- ħin mistenni biex ikun hemm trattament bid- dawl, 40- 50 sigħat wara l- injezzjoni, il- profili farmakokinetiċi ta ’ PhotoBarr fin- nisa u l- irġiel kienu bħal xulxin.
Porfimer sodium was not mutagenic in standard genotoxicity tests in the absence of light.
Porfimer sodium ma kienx mutaġeniku f’ testijiet ġenotossiċi standard fl- assenza tad- dawl.
With light activation, porfimer sodium was mutagenic in some in-vitro tests.
B’ attivazzjoni bid- dawl, porfimer sodium wera li huwa mutaġeniku f’ ċerti testijiet tal- laboratorju in vitro.
Reproductive toxicology studies were insufficient to support the safety of porfimer sodium during pregnancy, as no light activation had been used.
Studji tossikoloġiċi fuq is- sistema riproduttiva ma kienux biżżejjed biex jassiguraw is- sikurezza ta ’ porfimer sodium waqt it- tqala.
In these studies foetotoxicity, but not teratogenicity, occurred in rats and rabbits only at evaluated intravenous doses (greater than of equal to 4 mg/ kg) and at greater frequency (daily) compared in the clinical use.
Dan sar meta l- annimali ngħataw dożi elevati intravenużi (akbar jew daqs 4 mg/ kg) u bi frekwenza akbar (kuljum) meta mqabbla mal- użu fil- klinika.
Preclinical studies indicate that the excretion of porfimer sodium 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.
Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
Aċidu idrokloriku (għal aġġustament tal- pH) Idrossidu tas- sodju (għal aġġustament tal- pH)
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Dan il- prodott mediċinali m' għandux jitħallat ma ’ prodotti mediċinali oħrajn, ħlief dawk imsemmija f ’ sezzjoni 6. 6.
12 After reconstitution: use immediately (within 3 hours).
Wara li jiġi rikostitwit: użu minnufih (fi żmien 3 sigħat).
After it has been reconstituted, PhotoBarr should be used immediately (within 3 hours) and protected from light.
Huwa għandu jiġi mħares mid- dawl.
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.
From a microbiological point of view, the product should be used immediately.
Minn aspett mikrobijoloġiku, il- prodott għandu jintuża minnufih.
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.
Do not use after the expiry date stated on the carton and vial after EXP.
M’ għandekx tuża wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- kunjett wara JIS.
For storage conditions of the reconstituted medicinal product, see section 6.3.
Għal kundizzjonijiet ta ’ ħażna tal- prodott mediċinali rikostitwit, ara sezzjoni 6. 3
15 mg powder in a vial (glass type I, 7 ml capacity) with a grey butyl stopper.
15 mg trab f’ kunjett (ħġieġ tip I, jesa ’ 7 ml) b’ tapp griż tal- butyl.
1 vial.
Daqs tal- pakk: kunjett l.
Instructions for reconstitution PhotoBarr 15 mg vial should be reconstituted with 6.6 ml of 5% glucose solution for injection resulting in a final porfimer sodium concentration of 2.5 mg/ ml in the solution for injection.
Struzzjonijiet dwar ir- rikostituzzjoni Il- kunjett ta ’ 15 mg ta ’ PhotoBarr għandu jiġi rikostitwit b’ 6. 6 ml ta ’ 5% glucose ta ’ infużjoni intravenuża, għal konċentrazzjoni finali ta ’ 2. 5 mg/ ml ta ’ porfimer sodium għal soluzzjoni għall - injezzjoni.
Do not use other diluents.
Tużax dilwenti oħrajn.
Do not mix PhotoBarr with other medicinal products in the same solution.
M’ għandekx tħallat PhotoBarr ma ’ mediċini oħrajn fl- istess soluzzjoni.
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.
For most patients (up to 75 kg) two vials of PhotoBarr 75 mg will suffice.
Għal biċċa l- kbira tal- pazjenti (sa 75 kg) żewġ kunjetti ta ’ PhotoBarr 75 mg huma biżżejjed.
A PhotoBarr 15 mg vial will be needed for every additional 7.5 kg body weight.
Kull kunjett ta ’ 15 mg PhotoBarr ikun meħtieġ għal kull 7. 5 kg addizzjonali ta ’ piż tal- ġisem.
Spills and disposal Spills of PhotoBarr should be wiped up with a damp cloth.
13 Kull titjir ta ’ PhotoBarr għandu jintmesaħ b’ biċċa niedja.
Skin and eye contact should be avoided due to the potential for photosensitivity reactions upon exposure to light; use of rubber gloves and eye protection is recommended.
Kull kuntatt mal- ġilda u l- għajnejn għandu jiġi evitat minħabba l- potenzjal ta ’ reazzjonijiet fotosensittivi mal- espożizzjoni għad- dawl; l- użu ta ’ ingwanti u ta ’ protezzjoni tal- għajnejn huwa rakkomandat.
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.
Accidental exposure PhotoBarr is neither a primary ocular irritant nor a primary dermal irritant.
Espożizzjoni aċċidentali PhotoBarr la huwa irritant okulari primarju u lanqas irritant dermali.
However, because of its potential to induce photosensitivity, PhotoBarr might be an eye and/ or skin irritant in the presence of bright light.
Madankollu, minħabba l- probabilità li tiġi indotta fotosensittività, PhotoBarr jista ’ jkun irritant tal- għajnejn u/ jew tal- ġilda fil - preżenza ta ’ dawl luminuż.
It is important to avoid contact with the eyes and skin during preparation and/ or administration.
Huwa importanti li tevita l- kuntatt mal- għajnejn u mal- ġilda waqt il - preparazzjoni u/ jew l- għoti.
As with therapeutic overdose, any accidentally overexposed person must be protected from bright light .’
Bħal fil- każ ta ’ doża terapewtika, kull persuna li aċċidentalment ħa doża eċċessiva għandu jiġi protett mid- dawl luminuż.
Engelenkampstraat 72
Engelenkampstraat 72 NL- 6131JJ Sittard l- Olanda
25 March 2004 Date of latest renewal:
25 ta ’ Marzu 2004 Data tal- aħħar reviżjoni:
PhotoBarr 75 mg powder for solution for injection.
PhotoBarr 75 mg trab għal soluzzjoni għall- injezzjoni.
Each vial contains 75 mg porfimer sodium
Kull kunjett fih 75 mg porfimer sodium.
After reconstitution, each ml solution contains 2.5 mg porfimer sodium.
Wara r- rikostituzzjoni, kull ml ta ’ soluzzjoni fiha 2. 5 mg ta ’ porfimer sodium.
A dark red to reddish brown lyophilised powder or cake.
Trab (jew kejk) ta ’ kulur ħamrani skur għal kannella fl- aħmar.
- ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO).
Terapija fotodinamika (PDT) permezz ta ’ PhotoBarr hija ntiża għal asportazzjoni ta ’ displasja qawwija (HGD) f’ pazjenti li għandhom Esofagu ta ’ Barrett (BO).
Reconstituted PhotoBarr solution (ml) = Patient's weight (kg) x 2 mg/ kg = 0.8 x patient's weight 2.5 mg/ ml
Soluzzjoni ta ’ PhotoBarr rikostitwita (ml) = Piż tal- ġisem tal- pazjent (kg) x2 mg/ kg = 0. 8xpiż tal- ġisem 2. 5 mg/ ml
15 Progression to cancer was related to the number of PDT courses administered.
Il- progress għal kanċer kien relatat mal- għadd ta ’ korsijiet ta ’ PDT mogħtija.
Patients who received one course of PDT had a greater risk of progression to cancer than patients who received two or three courses of PDT (50% vs.
Pazjenti li rċevew kors wieħed ta ’ PDT kellhom riskju ogħla ta ’ firxa għal kanċer milli dawk li rċevew żewġ jew tliet korsijiet ta ’ PDT (50% kontra 39% u 11% rispettivament).
39% and 11% respectively)
Mod ta ’ amministrazzjoni
Method of administration For instructions on reconstitution prior to administration, see section 6.6
15 Għal struzzjonijiet dwar ir- rikostituzzjoni qabel l- għoti, ara sezzjoni 6. 6.
Physicians should be trained in the use of PDT.
It- tobba għandhom ikunu mħarrġin fl- użu ta ’ terapija fotodinamika.
PhotoBarr should be administered as a single slow intravenous injection over 3 to 5 minutes at 2 mg/ kg body weight.
L- injezzjoni ddum tingħata 'l fuq minn 3 minuti sa 5 minuti.
Treated Barrett's Mucosa Length (cm)
fl- esofagu ta ’ Barrett li jkun trattat (ċm)
Fibre Optic Diffuser Size (cm)
fibra ottika (ċm)
Balloon Window Size (cm)
bużżieqa (ċm)
The light dose (J/ cm)= power output from diffuser (W) x treatment time (sec) Diffuser length (cm)
Id- doża tad- dawl (J/ ċm) = Rata ta ’ enerġija li toħroġ mid- diffużur (W) x tul taż- żmien tat- trattament (sec) Tul tad- diffużur (ċm)
Fibre optic power outputs and treatment times required to deliver 130 J/ cm of diffuser length using the centring balloon
Rata ta ’ enerġija li toħroġ mid- diffużur tal- fibra ottika u tul ta ’ żmien tat- trattament meħtieġ biex iforni 130 J/ ċm ta ’ tul ta’ diffużur bil- bużżieqa li tiċċentra.
Diffuser
Qis tal- kanal Tul tal -
Light
Intensità
Required power
Rata ta ’
Treatment
Tul
window
tal- bużżieqa apparat
length (cm)
tad- dawl
intensity
enerġija meħtieġaa (W)
output from a
taż- żmien
time (sec)
taż- żmien
length (cm)
(ċm) (ċm)
(mW/ cm)
(mW/ ċm)
diffuser (W)
tat- trattam tat- trattame
1.35 1.90 1.40
1. 40
Diffuser
Tul tad -
Required power
Rata ta ’ enerġija
Treatment time Treatment time
Tul tat- trattament Tul tat- trattament
length (cm)
diffużur (ċm)
output from diffusera (W)
(W)
High-grade dysplasia in Barrett's oesophagus of < 7 cm
Displasja qawwija fl- esofagu ta ’ Barrett li huwa < 7 ċm
Light delivery devices NA
Mhux applikabbli
Photoactivation
Trattament biss
Laser Light Application a
għad- dawl laser a
Short (< 2.5 cm) fibre optic diffuser (50 J/ cm)
ċm) tal- fibra ottika (50 J/ ċm)
Treatment of "skip" areas only
taż- żoni maqbuża
Discrete nodules will receive an initial light application of 50 J/ cm (using short diffuser) before the balloon light application.
Għoqod diskreti jingħataw doża ta ’ dawl ta ’ 50 J/ ċm (jintuża diffuiżur qasir) fil- bidu qabel l- użu bid- dawl permezz tal- bużżieqa u l- apparat regolari.
Patients may receive a second course of PDT a minimum of 90 days after the initial therapy; up to three courses of PDT (each injection separated by a minimum of 90 days) should be given to a previously treated segment which still shows HGD or to a new segment if the initial Barrett's segment was > 7 cm in length.
Huma jistgħu jingħataw sa tlett korsijiet ta ’ terapija fotodinamika (kull injezzjoni tingħata mill- anqas 90 jum wara ta ’ qabel) fuq l- istess parti li tkun ġiet trattata qabel li tkun għadha turi HGD, kif ukoll meta l - parti ta ’ Barrett tkun oriġinalment > 7 ċm fit- tul.
Special populations
Popolazzjonijiet speċifiċi
Paediatric patients PhotoBarr is not recommended for use in children below age 18 years due to a lack of data on safety and efficacy.
Pazjenti pedjatriċi PhotoBarr m’ għandux jintuża fi tfal jew adoloxxenti taħt it- 18- il sena minħabba nuqqas ta ’ tagħrif fuq is- sigurtà u l- effikaċja.
Elderly patients(≥ 65 years old) Dose modification based upon age is not required.
Pazjenti anzjani (> 65 sena)
(see section 4.3).
Mhux meħtieġ li d- doża tiġi aġġustata minħabba l- età.
4.3 Contraindications
Indeboliment fil- kliewi L- influwenza ta ’ indeboliment fil- kliewi minħabba l- espożizzjoni għal porfimer sodium ma ġietx evalwata (ara sezzjoni 4. 3).
- Hypersensitivity to the active substance, other porphyrins or to any of the excipients.
Indeboliment fil- fwied L- influwenza ta ’ indeboliment fil- fwied minħabba l- espożizzjoni għal porfimer sodium ma ġietx evalwata (ara sezzjonijiet 4. 3 u 4. 4)
- Severe renal and/ or hepatic impairment.
4. 3 Kontraindikazzjonijiet
- Oesophageal or gastric varices or patients with oesophageal ulcers > 1 cm in diameter.
Variċi fl- esofagu jew fl- istonku jew ulċeri fl- esofagu b’ dijametru > 1 ċm.
- Tracheo-oesophageal or broncho-oesophageal fistula.
Fistula fit- trakea- esofagali jew bronko- esofagali.
- Suspected erosion of major blood vessels due to risk of massive, potentially fatal haemorrhage.
Ħjiel ta ’ tgħawwir fil- vażi tad- demm maġġuri minħabba riskju ta ’ emorraġija serja li tista ’ tkun fatali.
Efficacy and especially safety of PDT with PhotoBarr have not been established in patients with contraindications to, or not being eligible for, oesophagectomy.
L- effikaċja u fuq kollox is- sigurtà ta ’ meta tingħata terapija fotodinamika b’ PhotoBarr, ma ġewx mistħarrġa f’ pazjenti li huma kontra- indikati jew mhux elliġibli għal esofagotomija.
Photodynamic therapy with PhotoBarr has exclusively been studied in patients not suffering from severe medical conditions, such as
It- terapija fotodinamika b’ PhotoBarr ġiet mistħarrġa biss f’ pazjenti li ma ’ kellhomx mard serju, bħal
18 congestive heart failure of advanced stage or serious pulmonary conditions that might impair the eligibility of patients for surgical procedures.
18 insuffiċjenza kardijaka konġestiva fi stadju avvanzat, jew mard serju fil- pulmun li jista ’ jinibixxi l - pazjent minn intervent kirurġiku.
In clinical trials, PhotoBarr PDT has only been tested in patients being treatment naive concerning mucosal ablative therapy.
Terapija fotodinamika b’ PhotoBarr ġiet ippruvata waqt provi kliniċi fuq pazjenti mhux konxji mit - trattament ta ’ asportazzjoni mukuża.
Safety and efficacy in patients with treatment failure of other local mucosal ablative therapy has not been evaluated.
Ma ġewx mistħarrġa s- sigurtà u l- effikaċja f’ pazjenti li ma ’ rnexxewlhomx trattamenti lokali oħrajn ta ’ asportazzjoni mukuża.
Patients older than 75 years may be at a higher risk of respiratory related adverse events such as pleural effusion and dyspnoea
Pazjenti li għandhom iktar minn minn 75 sena jista ’ jkollhom riskju akbar minħabba effetti avversi fis - sistema respiratorja, bħal effużjoni plewrali u qtugħ ta ’ nifs.
Photosensitivity All patients who receive PhotoBarr will be photosensitive and must observe precautions to avoid exposure of skin and eyes to direct sunlight or bright indoor light (from examination lamps, including dental lamps, operating room lamps, unshaded light bulbs at close proximity, neon lights, etc.) for at least 90 days after treatment as some patients may remain photosensitive for up to 90 days or more.
Għalhekk għandhom jieħdu prekawzjonijiet kontra l- espożizzjoni tal- ġilda u l- għajnejn mid- dawl dirett tax- xemx jew dawl minn lampi qawwija (lampi li jintużaw biex jeżaminaw, inklużi lampi tad- dentist, lampi tal- kamra tal - interventi kirurġiċi, bozoz mikxufa mill- viċin, dawl neon, eċċ.).
During this period, patients should wear dark sunglasses, which have an average white light transmittance of < 4% when outdoors.
Tul dan il- perijodu, il- pazjenti għandhom jilbsu nuċċali tax- xemx skur, li bħala medja jittrażmetti dawl abjad < 4% meta jkunu barra.
The photosensitivity is due to residual photoactive substances, which will be present in all parts of the skin.
Din is- sensittività eċċessiva għad - dawl hija minħabba sustanzi fotoattivi li jibqgħu preżenti fil- ġilda kollha.
Exposure of the skin to ambient indoor light is, however, beneficial because the remaining medicinal product will be inactivated gradually through a photo- bleaching reaction.
Madankollu, l- espożizzjoni tal- ġilda għal dawl ambjentali ġewwa d- dar, hija ta ’ ġid, għax b ’ hekk id- droga żejda tiġi nnewtralizzata bid- dawl.
The level of photosensitivity will vary for different areas of the body, depending on the extent of previous exposure to light.
Ir- reazzjoni tal - ġilda għad- dawl tvarja skond il- parti tal- ġisem, u tiddependi fuq kemm il- ġilda tkun ġiet esposta għad - dawl qabel.
Hepatic Impairment No pharmacokinetic and safety data in patients with hepatic impairment are available.
Indeboliment epatiku Ebda tagħrif farmakokinetiku u dwar is- sigurtà f’ pazjenti b’ indeboliment epatiku mhux disponibbli.
19 Prophylactic use of corticosteroids to reduce stricture formation should be avoided during PDT as its use has shown not to reduce, and may worsen, stricture formation.
Dan għaliex ġie ppruvat li ma jaħdmux, u jistgħu jaggravaw is- sitwazzjoni.
PhotoBarr PDT regularly causes dysphagia, odynophagia, nausea and vomiting.
It- terapija fotodinamika b’ PhotoBarr regolarment tikkaġuna disfaġja, odinofaġja, dardir, u rimettar.
If PDT is to be used before or after radiotherapy, sufficient time should be allowed between the therapies to ensure that the inflammatory reaction produced by the first treatment has subsided prior to commencement of the second treatment.
Jekk terapija fotodinamika tkun ser tingħata qabel jew wara radjoterapija, għandu jgħaddi żmien biżżejjed bejn iż- żewġ trattamenti biex jiġi żgurat li l- infjammazzjoni kkaġunata mill- ewwel trattament tkun marret, qabel jinbeda t- tieni wieħed.
No formal interaction studies have been performed with PhotoBarr investigating pharmacokinetic product interactions with other medicinal products.
Ma kien hemm l- ebda studju formali dwar kif prodotti mediċinali – prodott mediċinali ieħor u PhotoBarr jaffettwaw il- kwalitajiet farmakokinetiċi ta ’ xulxin.
Compounds that quench active oxygen species or scavenge radicals, such as dimethyl sulphoxide, b- carotene, ethanol, formate and mannitol would be expected to decrease PDT activity.
Eżempji ta ’ sustanzi bħal dawn huma dimethyl sulphoxide, b- carotene, ethanol, formate u mannitol.
Preclinical data also suggest that tissue ischaemia, allopurinol, calcium channel blockers and some prostaglandin synthesis inhibitors could interfere with PhotoBarr PDT.
Informazzjoni ta ’ qabel l- użu kliniku tissuġerixxi li iskemja fit- tessut, allopurinol, imblokkaturi tal- kanali tal- kalċju u inibituri tal - produzzjoni ta ’ prostaglandins, jistgħu jinterferixxu ma ’ terapija fotodinamika ta ’ PhotoBarr.
Pregnancy There are no clinical data on exposed pregnancies available for porfimer sodium.
20 M’ hemmx tagħrif kliniku tal- effett ta ’ porfimer tas- sodju fuq it- tqala.
Animal studies are insufficient with respect to effects on pregnancy, embryo/ foetal development, parturition and postnatal 20 development (see section 5.3).
L- istħarriġ fuq l- annimali dwar t- tqala, l- iżvilupp tal- fetu, il- proċess tat- twelid, u l- iżvillup ta ’ wara, m’ huwiex biżżejjed (ara sezzjoni 5. 3).
The potential risk for humans is unknown.
Ir- riskju li jista ’ jkun hemm meta jintuża fil- bniedem mhux magħruf.
Porfimer sodium should not be used during pregnancy unless clearly necessary.
Porfimer tas- sodju m’ għandux jintuża waqt it- tqala sakemm ma jkunx hemm triq oħra.
Women of child-bearing potential should use effective contraception before, during and for at least 90 days after treatment.
Nisa li jistgħu jinqabdu tqal għandhom jużaw mezzi ta ’ kontraċezzjoni qabel, waqt u sa 90 jum wara t - trattament.
Lactation It is not known whether porfimer sodium is excreted into human breast milk.
Treddigħ Mhux magħruf jekk fil- bniedem, porfimer sodium jiġix eliminat fil- ħalib tas- sider jew le.
In rats porfimer sodium passed into breast milk.
Fil- firien li jreddgħu nstab li porfimer sodium jgħaddi ġol- ħalib tas- sider.
Breastfeeding should be terminated prior to treatment.
Għaldaqstant, la m’ hemmx informazzjoni dwar dan fil- bniedem, il- ħalib tas- sider għandu jitwaqqaf qabel it- trattament.
For the PDT procedure, sedation may be required and consequently caution should be taken.
PhotoBarr m’ għandu l- ebda effett jew ftit li xejn fuq il- ħila ta ’ sewqan u l- użu ta ’ magni.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetaà tagħhombl- aktar serji jitniżżlu l- ewwel.
Summary of adverse reactions with porfimer sodium in patients with HGD and BO
Ġabra fil- qosor ta ’ reazzjonijiet avversi b’ porfimer sodium f’ pazjenti b’ HGD u BO.
Neoplasms benign,
Infezzjonijiet u infestazzjonijiet Mhux komuni:
Bronchitis, nail fungal infection, sinusitis, skin infection malignant and unspecified (incl cysts and polyps)
Bronkite, infezzjonijiet fungali fid- dwiefer, sinusite, infezzjonijiet fil- ġilda
21 Metabolism and nutrition disorders Very common:
21 Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi) Mhux komuni:
Dehydration Common:
Lewkoċitożi Disturbi fil -- metabolismu u n- nutrizzjoni Komuni ħafna:
Uncommon:
Deidratazzjoni Komuni:
Appetite decreased, electrolyte imbalance Hypokalaemia
Tnaqqis fl- aptit, żbilanċ elettrolitiku
Headache, paraesthesia, dysgeusia Dizziness, hypoaesthesia, tremor
Uġigħ ta ’ ras, paresteżja, disgewsia
Ear and labyrinth disorders Uncommon:
Irritazzjoni fil- għajnejn, edema fl- għajnejn Disturbi fil- widnejn u sistema labrintika Mhux komuni:
Vascular disorders Uncommon:
Angina pectoris, fibrillazzjoni atrijali, tħabbit irregolari fl- arterji, skonfort fis - sider Disturbi vaskulari Mhux komuni:
Hypertension, haemorrhage, hot flushes, hypotension, orthostatic hypotension
Pressjoni għolja, emorraġija, fwawar, pressjoni baxxa, pressjoni baxxa meta bil- wieqfa Disturbi respiratorji, toraċiċiu medjastinali
Uncommon:
Mhux komuni: imnieħer,
Pleural effusion, pharyngitis, atelectasis, dyspnoea Choking, dyspnoea exertional, haemoptysis, hypoxia, nasal congestion, pneumonia aspiration, productive cough, respiratory depression, respiratory tract congestion, wheezing
Effużjoni plewrali, farinġite, atelektażi, qtugħ ta ’ nifs Tifga, qtugħ ta ’ nifs meta tagħmel sforz, emoptisi, ipoksja, konġestjoni fl - infjammazjoni tal- pulmun minħabba aspirazzjoni, sola misjura, dipressjoni respiratorja, konġestjoni fl- apparat tas- sistema respiratorja, tħarħir
Hiccups, odynophagia, diarrhoea, dyspepsia, oesophageal ulcer, abdominal pain upper, abdominal pain, haematemesis, oesophageal pain, eructation, melaena (haematocheznia), oesophageal disorder, regurgitation of food, abdominal rigidity, oesophageal spasm, oesophagitis.
sulluzzu, odinofagja, dijarea, dispepsja, ulċera fl- esofagu, uġigħ fin naħa ta ’ fuq tal- addome, uġigħ fl- addome, haematemesis, uġigħ fl- esofagu, tifwiq, melaena (ematoċeznija), disturb fl- esofagu, rigurġitazzjoni tal- ikel, spażmu fl- esofagu, esofaġite.
Uncommon:
Disturbi muskolu- skeltrali u tal- connective tissue
22
22 Komuni:
Congenital and familial and genetic disorders Uncommon:
Mhux komuni:
Pigmented naevus
Uġigħ fid- dahar, uġigħ fir- riġlejn Ġbid fil- ġogi, tnaqqis fil- movimenti tal- ġogi, uġigħ fil- muskoli u għadam tas - sider, plantar faxxite
General disorders and administration site conditions Very common:
Gynaecomastia Disturbi konġenitali u ġenetiċi Mhux komuni:
Pyrexia Common:
Naevus ippigmentat Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata Komuni ħafna:
Uncommon:
Deni Komuni:
Rigors, fatigue Feeling hot, injection site erythema, lethargy, malaise, oedema peripheral, pain, pitting oedema, temperature intolerance, weakness
Rogħda ta ’ bard, għajja
Weight decreased, body temperature increased Blood albumin decreased, blood chloride increased, blood urea increased, haematocrit decreased, haemoglobin decreased, oxygen saturation decreased, protein total decreased
Telf fil- piż, żieda fit- temperatura tal- ġisem Tnaqqis fil- livelli tal- albumina fid- demm, żieda fil- livelli ta ’ klorur fid- demm, żieda fil- livelli ta ’ urea fid- demm, tnaqqis fil- livelli tal- ematokrit, tnaqqis fil - livelli tal - emoglobina, tnaqqis fil- livelli tas- saturazzjoni tal- ossiġnu, tnaqqis fil- livelli tal- proteini totali
Injury, poisoning, and procedural complications Common:
Korriment, avvelenament u komplikazzjonijiet ta ’ xi proċedura Komuni:
The majority of the SAEs experienced were gastrointestinal disorders (8% - 11 patients), specifically nausea (3% - 4 patients), vomiting (3% - 4 patients) and upper abdominal pain (2% - 2 patients).
Fil- biċċa l- kbira, r- reazzjonijiet avversi li kienu serji li effettwaw ħdax il- pazjent, kienu problemi fis- sistema diġestiva (8% - 11 pazjenti), b’ mod speċifiku d- dardir (3% - 4 pazjenti), rimettar (3% - 4 pazjenti), u uġigħ fin- naħa ta ’ fuq tal- addome (2% - 2 pazjenti).
The majority of treatment-associated oesophageal stenosis (which includes oesophageal narrowing and oesophageal strictures) reported in the PhotoBarr PDT + OM group were of mild or moderate intensity (92%).
Fil- biċċa l- kbira ta ’ trattamenti assoċjati ma ’ stenożi tal- esofagu (li jinkludu tidjiq u kontrazzjonijiet fl - esofagu) li ġew rapportati fil- grupp ta ’ PhotoBarr PDT + OM, kienu ta ’ natura hafifa jew moderata (92%).
A 51 year-old obese man was treated with PhotoBarr PDT for HGD in BO, off label.
Raġel oħxon ta ’ 51 sena kien ittrattat b’ terapija fotodinamika, PhotoBarr għal HGD fl- esofagu ta ’ Barrett (mingħajr tikketta).
The recommended 2 mg/ kg dose, instead of the recommended single administration, was given twice two days apart (10 patients) and three times within two weeks (1 patient) without any notable adverse reactions being reported.
Dożi ogħla tal- prodott mediċinali minn dawk rakkomandati ta ’ 2 mg/ kg, ngħataw f’ intervall ta ’ jumejn (f’ 10 pazjenti), u tlett dożi ta ’ 2 mg/ kg, li ngħataw f’ intervall ta ’ ġimagħtejn (f’ pazjent wieħed), kienu tollerati mingħajr reazzjonijiet avversi.
Laser treatment should not be given if an overdose of PhotoBarr is administered.
Pazjenti
In the event of an overdose, patients should protect their eyes and skin from direct sunlight or bright indoor lights for 90 days.
23 li jkunu ħadu doża eċċessiva għandhom iħarsu għajnejhom u l- ġilda minn dawl dirett tax- xemx, jew lampi qawwija ta ’ ġewwa għal 90 jum.
One patient experienced life-threatening dyspnoea and the others had no notable complications.
Pazjent wieħed sofra qtugħ ta ’ nifs letali, filwaqt li l- bqija ma kellhomx komplikazzjonijiet.
Sensitizers used in photodynamic/ radiation therapy, ATC code:
Sensitizzaturi użati għal terapija fotodinamika/ radjazzjoni, Kodiċi ATC:
Mechanism of action Porfimer sodium is a mixture of porphyrin units, which are linked together in chains of two to eight units.
Mekkaniżmu t’ azzjoni Porfimer sodium hija taħlita ta ’ unitajiet ta ’ porphyrin, li huma marbutin flimkien fi ktajjen ta ’ bejn żewġ u tmien unitajiet.
The cytotoxic actions of porfimer sodium are light and oxygen-dependent.
L- azzjoni ċitotossika ta ’ porfimer sodium tiddependi fuq dawl u ossiġnu.
Photodynamic therapy with PhotoBarr is a 2-stage process.
Terapija fotodinamika b ’ PhotoBarr tikkonsisti f’ żewġ stadji.
The first stage is the intravenous injection of PhotoBarr.
L- ewwel proċess jinvolvi injezzjoni ġol - vina b ’ PhotoBarr.
Clearance from a variety of tissues occurs over 40-72 hours, but tumours, skin, and organs of the reticuloendothelial system (including liver and spleen) retain porfimer sodium for a longer period.
Ir- rata ta ’ eliminazzjoni ta ’ PhotoBarr minn tessuti diversi tieħu l- fuq minn 40- 72 sigħat, iżda tumuri, ġilda, u l- organi tas- sistema retikulo- endoteljali (li jinkludu l- fwied u l- milsa) iżżommu porfimer sodium għal perjodu itwal.
Illumination of the target area with 630 nm wavelength laser light constitutes the second stage of therapy.
It- tieni parti tat- terapija tinvolvi l- espożizzjoni għad - dawl laser b ’ 630 nm wavelength, fuq il- parti li jkollha bżonn it- trattament.
Clinical efficacy In a controlled clinical trial, a PhotoBarr PDT + OM (omeprazole) patient group (n=183) was compared to a group of patients receiving OM only (n=70).
Effikaċja klinika Fi prova klinika kkontrollata, grupp ta ’ pazjenti li kienu fuq PhotoBarr PDT + OM ġew mqabbla ma ’ grupp ta ’ pazjenti li kienu ngħataw OM biss (n=70).
Eligible patients for this study were to have biopsy-proven HGD in Barrett’ s oesophagus (BO).
Il- pazjenti li kienu eliġibbli f’ dan l- istudju kellhom HGD fl- esofagu ta ’ Barrett (BO) li ġie kkonfermat b’ biopsija.
Co-administration of omeprazole (20 mg BID) began at least 2 days before PhotoBarr injection.
L- għoti flimkien ma ’ omerprazole (20 mg BID) beda tal- anqas jumejn qabel l- injezzjoni ta ’ PhotoBarr.
Patients randomised to the OM only group received orally omeprazole 20 mg BID for the duration of the study.
Pazjenti li ġew magħżula b’ modd randomised fil- grupp OM, ngħataw mill - ħalq 20 mg omeprazole BID, matul dan l- istudju.
Patients were followed every 3 months until 4 consecutive, quarterly follow-up endoscopic biopsy results were negative for HGD, and then biannually until the last enrolled patient had completed a minimum of 24 months of follow-up evaluations after randomisation.
Il- pazjenti ġew sorveljati kull 3 xhur sakemm ir- riżultati tal- biopsija u l- endoskopija urew għal erba ’ darbiet wara xulxin li ma ’ kienx hemm HGD u mbagħad darbtejn f’ sena sakemm l- agħar pazjent arwolat kien lesta minimu ta ’ 24 xahar ta ’ evalwazzjonijiet wara randomizzazzjoni.
PhotoBarr PDT + OM was effective in eliminating HGD in patients with BO.
24 PhotoBarr PDT + OM kien effettiv biex inneħħi HGD f ’ pazjenti b ’ esofagu ta ’ Barrett.
These results confirm those observed after a minimum of 6 months follow-up which showed HGD ablation in 72% of patients in the PhotoBarr PDT + OM group compared to 31% in the OM only group.
Dawn ir- riżultati jikkonfermaw oħrajn li wara mill- anqas sorveljanza ta ’ 6 xhur kien hemm fejqan minn HGD f ’ 72% tal- pazjenti li kienu fil - grupp PhotoBarr PDT + OM, meta mqabbla ma ’ 31% fil- grupp OM biss.
24 By the end of the minimum follow-up of two years, 13% in the PhotoBarr PDT + OM group had progressed to cancer compared to 28% in the OM only group in the intent-to-treat (ITT) population.
Wara mill- anqas sentejn sorveljanza, 13% tal- grupp PhotoBarr PDT + OM, żviluppaw kanċer, meta mqabbla ma ’ 28% fil grupp li użaw OM biss fil- popolazjoni ITT (intent to treat).
Comparison between the survival curves of the two treatment arms using the log rank test showed a statistically significant difference between the curves of the two groups in the ITT population (p=0.0014) indicating a significant delay in the progression to cancer.
Din tindika dewmien sinifikanti fl- iżvilupp tal- kanċer.
The pharmacokinetics of porfimer sodium have been studied in 12 patients with endobronchial cancer and 23 healthy subjects (11 men and 12 women), given 2 mg/ kg porfimer sodium through slow intravenous injection.
Studju farmakokinetiku sar fuq 12- il pazjent li kellhom kanċer fil- bronki u 23 individwu b’ saħħtu (11 - il raġel u 12- il mara) li ngħataw 2 mg/ kg portimer sodium b’ injezzjoni ġol- vina bil- mod.
Plasma samples were obtained up to 56 days (patients) or 36 days (volunteers) post injection.
Kampjuni tal- plażma ttieħdu sa 56 jum (pazjenti) jew 36 jum (voluntieri) wara l- injezzjoni.
61%, range 39-222), whereas in volunteers Cmax was 40 μ g/ ml and AUCinf was 2400 μ g/ h/ ml.
Fil- pazjenti, il- medja ta ’ l- ogħla konċentrazzjoni fil- plażma (Cmax) kienet ta ’ 79. 6 μg/ ml (CV 61%, medda ta ’ 39- 222), filwaqt li tal- voluntieri Cmax kien ta ’ 40 μg/ ml u AUCinf kien ta ’ 2400 μg/ ml..
Distribution In vitro binding of porfimer sodium to human serum protein is around 90% and independent of concentration between 20 and 100 μ g/ ml.
Distribuzzjoni Madwar 90% ta ’ porfimer sodium jeħel in vitro ma ’ proteini tas- serum fil- ġisem tal- bniedem, b ’ mod indipendenti mill- konċentrazzjoni ta ’ bejn 20 u 100 μg/ ml.