natgillin/translations-raw huggingface dataset:
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. 
Bolniki, ki so bili naključno izbrani za zdravljenje s PDT, so dobivali PhotoBarr v odmerku 2 mg/kg telesne mase s počasno intravensko injekcijo v času 3 do 5 minut.
o all patients should know that UV blocking is not effective in blocking visible light which activates porfimer. 
o Vsi bolniki se morajo poučiti o tem, da UV-zaščita nima zaščitnega delovanja pri vidni svetlobi, s kakršno se porfirini aktivirajo.
Patients were excluded from the study if there was a presence of invasive oesophageal cancer, if they had a history of cancer other than nonmelanoma skin cancer or if they had received prior PDT to the oesophagus. 
Bolnike so izključili iz raziskave, če so imeli invazivni rak požiralnika, rak v anamnezi, razen kožnega raka, ki ni bil melanom, ali če so poprej dobili PDT v požiralnik.
Keep the vial in the outer carton in order to protect from light. 
Vialo hranite v zunanji ovojnini, da jo zaščitite pred svetlobo.
In an open label pharmacokinetic study, all 24 healthy subjects experienced photosensitivity reactions, which were characteristically represented by erythematous rash and oedema and were mild to moderate in intensity. 
V odprti farmakokinetični raziskavi je imelo vseh 24 zdravih prostovoljcev preobčutljivostne reakcije na svetlobo, za katere je bil značilen eritematozni izpuščaj in edem blage do zmerne stopnje.
Laser light 
Laserska svetloba
Reconstituted PhotoBarr solution (ml) = Patient's weight (kg) x 2 mg/kg = 0.8 x patient's weight 
Rekonstituirana raztopina PhotoBarra (ml) = bolnikova masa (kg) x 2 mg/kg = 0,8 x bolnikova masa
Patient guide − Brief background and introduction to Barrett's oesophagus and high grade 
Navodila za bolnike − Kratek opis in razlaga Barretovega požiralnika ter visoke stopnje displazije
First light application 
Prva uporaba svetlobe
Photodynamic therapy with PhotoBarr is a two-stage process requiring administration of both medicinal product and light. 
Fotodinamično zdravljenje s PhotoBarrom je dvostopenjski proces, ki zahteva uporabo tako zravila kot svetlobe.
Both residual and additional segments may be treated in the same light session(s) if the total length of the segments treated with the balloon/diffuser combination is not greater than 7 cm. 
Tako preostali kot dodatni segmenti, se lahko zdravijo s svetlobo v času istih obiskov, če celotna dolžina segmentov, zdravljenih s kombinacijo balona/difuzorja, ni večja od 7 cm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uncommon: 
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) Občasne:
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. 
Podrobne informacije o tem zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA): http://www.ema.europa.eu/.
Spills of PhotoBarr should be wiped up with a damp cloth. 
Razlit PhotoBarr obrišite z vlažno krpo.
− It is important that patients tell their doctor if they get exposed to sunlight after receiving treatment with PhotoBarr. 
− Pomembno je, da bolniki opozorijo zdravnika, če so bili po zdravljenju s PhotoBarrom izpostavljeni svetlobi.
Tumour cell death also occurs through ischaemic necrosis secondary to vascular occlusion that appears to be partly mediated by thromboxane A2 release. 
Uničenje tumorskih celic prav tako nastopi s pomočjo ishemične nekroze, ki nastane kot posledica žilne okluzije, za katero se zdi, da jo delno povzroči sproščanje tromboksana A2.
A maximum of 7 cm of Barrett's mucosa is treated at the first light session using an appropriate size of centering balloon and fibre optic diffuser (Table 1). 
Pri prvem zdravljenju s svetlobo se zdravi največ 7 cm sluznice Barrettovega požiralnika z uporabo primerne velikosti balona za centriranje in difuzorja z optičnimi vlakni (Preglednica 1).
A second laser light application may be given to a previously treated segment that shows a 'skip' area, (i.e., an area that does not show sufficient mucosal response) using a short < 2.5 cm fibre optic diffuser at the light dose of 50 J/cm of diffuser length (see Table 3). 
Prej zdravljenemu segmentu se lahko doda druga uporaba laserske svetlobe, ki kaže »izpuščeno« področje (tj. področje, ki ne kaže zadostnega odziva sluznice pri uporabi < 2,5 cm difuzorja z kratkimi optičnimi vlakni pri odmerku svetlobe 50 J/cm dolžine difuzorja (glejte Preglednico 3).
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). 
Večina HNU so bile prebavne motnje (8% - 11 bolnikov), posebno slabost (3% - 4 bolniki), bruhanje (3% - 4 bolniki) in bolečine v zgornjem delu trebuha (2% - 2 bolnika).
Spin transfer from porfimer sodium to molecular oxygen may then generate singlet oxygen. 
Sučni prenos od porfimer-natrija do molekulskega kisika lahko nato proizvede kisik singlet.
Other exclusion criteria were patients in whom omeprazole therapy was contraindicated. 
Drugi kriteriji za izločitev so bili bolniki, pri katerih je bilo zdravljenje z omeprazolom kontraindicirano.
It is possible that concomitant use of other photosensitising agents (e.g., tetracyclines, sulphonamides, phenothiazines, sulphonylurea hypoglycaemic agents, thiazide diuretics, griseofulvin and fluoroquinolones) could increase the photosensitivity reaction. 
Možno je, da sočasna uporaba drugih snovi, ki povečujejo občutljivost za svetlobo (npr. tetraciklinov, sulfonamidov, fenotiazinov, hipoglikemičnih pripravkov sulfoniluree, tiazidnih diuretikov, grizeofulvina ter fluorokinolonov) lahko poveča fotosenzitivno reakcijo.
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
One patient experienced life-threatening dyspnoea and the others had no notable complications. 
Pri enem bolniku se je pojavila smrtno nevarna dispneja, pri drugih pa ni bilo večjih težav.
- Severe renal and/or hepatic impairment. 
- Huda ledvična in/ali jetrna okvara.
No formal interaction studies have been performed with PhotoBarr investigating pharmacokinetic interactions with other medicinal products. 
Opravljene niso bile nobene predpisane raziskave s PhotoBarrom o medsebojnem delovanju, ki bi preučevale farmakokinetične interakcije z drugimi zdravili.
Do not use PhotoBarr after the expiry date which is stated on the carton and vial after EXP. 
PhotoBarra ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatlici in viali za oznako EXP.
Bronchitis, nail fungal infection, sinusitis, skin infection 
Bronhitis, glivične okužbe nohtov, sinuzitis, infekcije kože
PhotoBarr injection: You will receive one intravenous injection of PhotoBarr (2 mg per kg of body weight) 40 to 50 hours before laser light treatment. 
Injiciranje zdravila PhotoBarr: Prejeli boste eno intravensko injekcijo PhotoBarra (2 mg na kg telesne mase) 40 do 50 ur pred zdravljenjem z lasersko svetlobo.
After it has been reconstituted, PhotoBarr should be used immediately (within 3 hours) and protected from light. 
Po pripravi je treba PhotoBarr takoj uporabiti (v 3 urah) in ga zaščititi pred svetlobo.
What PhotoBarr looks like and contents of the pack PhotoBarr is a reddish brown powder for solution for injection. 
Izgled zdravila PhotoBarr in vsebina pakiranja PhotoBarr je rdečkastorjav prašek za raztopino za injiciranje.
Tissue damage also results from ischaemia secondary to vasoconstriction, platelet activation and aggregation and clotting. 
Tudi poškodba tkiva je posledica ishemije, ki nastane ob vazokonstrikciji, aktivaciji in agregaciji ter strjevanju trombocitov.
B CONDITIONS OF THE MARKETING AUTHORISATION 
B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
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%). 
Večina stenoz požiralnika, povezanih z zdravljenjem (ki vključuje zoženje in strikture požiralnika), o katerih so poročali v skupini, ki je dobivala PhotoBarr PDT + OM, je bila blagih do srednje hudih (92%).
The most frequently reported adverse reactions were photosensitivity reactions (69%), oesophageal stenosis (40%), vomiting (32%), chest pain of non-cardiac origin (20%), pyrexia (20%), dysphagia (19%), constipation (13%), dehydration (12%) and nausea (11%). 
Najpogostejši opaženi neželeni učinki so bile preobčutljivostne reakcije na svetlobo (69%), ezofagealna stenoza (40%), bruhanje (32%), bolečina v prsih, ki ni povezana s srcem/ki nima izvora v srcu (20%), pireksija (20%), disfagija (19%), zaprtje (13%), dehidracija (12%) in slabost (11%).
Back pain, pain in the limb 
Bolečina v hrbtu, bolečina v okončinah
The medicinal product should only be administered when material and personnel experienced in evaluating and treating anaphylaxis are immediately available. 
Zdravilo dajemo le takrat, ko je na voljo material in osebje, izkušeno v ocenjevanju in zdravljenju anafilaksije.
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. 
Vsi bolniki, ki dobivajo PhotoBarr, so občutljivi na svetlobo in morajo upoštevati posebna opozorila, da se izognejo izpostavljenosti kože in oči neposredni sončni svetlobi ali močni notranji svetlobi (svetilke za opazovanje, vključno z zobozdravstvenimi svetilkami, lučmi v operacijskih dvoranah, nezasenčenimi žarnicami v neposredni bližini, neonskimi lučmi itd.), najmanj 90 dni po zdravljenju, ker lahko nekateri bolniki ostanejo občutljivi na svetlobo še do 90 dni ali več.
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). 
Pri dvainpetdesetih odstotkih bolnikov v skupini, ki je dobivala PDT + OM, je bil ploščatocelični epitelij normalen, medtem ko je bilo pri 59% bolnikov opaziti odsotnost displazije v primerjavi s 7% ter 14% v skupini, ki je dobivala samo OM (p<0,0001).
PhotoBarr should not be used in children and adolescents below 18 years of age, due to lack of experience. 
Pri otrocih in mladostnikih, mlajših od 18 let, se zdravilo PhotoBarr zaradi pomanjkanja izkušenj ne priporoča.
All patients who receive PhotoBarr will be photosensitive and must observe precautions to avoid sunlight and bright indoor light (see section 4.4). 
Vsi bolniki, ki dobivajo PhotoBarr, so občutljivi na svetlobo in morajo upoštevati previdnostne ukrepe, da se izognejo sončni svetlobi in močni notranji svetlobi (glejte poglavje 4.4).
PhotoBarr is a light-activated medicine used photodynamic therapy (PDT)in combination with a non-burning, red laser light. 
PhotoBarr je zdravilo, ki ga aktivira svetloba, in se uporablja za fotodinamično zdravljenje (PDT) (photodynamic therapy) v kombinaciji z rdečo nevročo lasersko svetlobo.
You may receive a second laser light treatment 96-120 hours after the initial injection of PhotoBarr. 
Prejmete lahko tudi drugo zdravljenje z lasersko svetlobo 96-120 ur po začetnem vbrizganem odmerku PhotoBarra.
The second stage of therapy is illumination with laser light 40-50 hours following injection with PhotoBarr. 
Druga stopnja zdravljenja je osvetlitev z lasersko svetlobo 40-50 ur po injiciranju
Repeat light application 
Ponovljena uporaba svetlobe
Very common: Oesophageal stenosis acquired*, vomiting*, dysphagia, constipation, 
Zelo pogoste: Pridobljena ezofagealna stenoza*, bruhanje*, disfagija, zaprtje, slabost*.
If eating or drinking becomes impossible or if you keep vomiting, please return to the clinical for medical attention. 
Če ne morete jesti ali piti, ali če se bruhanje ponavlja, pojdite nazaj na kliniko, kjer vam bodo nudili zdravniško pomoč.
Both the medicine and laser light are necessary for the therapy to work. 
Za uspešnost zdravljenja sta potrebna tako zdravilo kot laserska svetloba.
The first stage is the intravenous injection of PhotoBarr. 
Prva stopnja je intravensko injiciranje PhotoBarra.
Eligible patients for this study were to have biopsy-proven HGD in Barrett's oesophagus (BO). 
Bolniki, primerni za to raziskavo, so morali imeti z biopsijo potrjeno HGD v Barrettovem požiralniku (BP).
In rats porfimer sodium passed into breast milk. 
Pri podganah je porfimer-natrij prehajal v materino mleko.
The treatment regimen is summarized in Table 4. 
Način dajanja odmerkov je na kratko prikazan v Preglednici 4.
Patients randomised to the OM only group received orally omeprazole 20 mg BID for the duration of the study. 
Bolniki, ki so bili naključno razvrščeni v skupino, ki je dobivala samo OM, so dobili 20 mg omeprazola peroralno dvakrat na dan v času raziskave.
The first laser light session occurred 40-50 hours after injection and a second session, if indicated, occurred 96-120 hours after injection. 
Prvo zdravljenje z lasersko svetlobo je potekalo 40-50 ur po injiciranju, drugo, če je bilo potrebno, pa 96-120 ur po injiciranju.
Musculoskeletal and connective tissue disorders Common: 
Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogoste:
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 15 mg 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 15 mg
Psychiatric disorders Common: 
Psihiatrične motnje Pogoste:
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. 
Krivulje preživetja so pokazale, da so imeli do konca celotnega spremljevalnega obdobja bolniki v skupini, ki je dobivala PhotoBarr PDT + OM, 83% možnost, da ne zbolijo za rakom, v primerjavi s 53% možnostjo pri bolnikih, ki so se zdravili samo z OM.
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 se uporablja za odpravo displazije (celice z netipičnimi spremembami, ki povečujejo tveganje za razvoj raka) visoke stopnje pri bolnikih z Barrettovim požiralnikom.
These manifestations may be attributable to a pseudoporphyria state (temporary medicinal product-induced cutaneous porphyria). 
Te pojave lahko pripišemo stanju psevdoporfirije (trenutna kožna porfirija, ki nastane zaradi zdravila).
PhotoBarr is for single use only and any unused solution should be discarded. 
PhotoBarr je namenjen za enkratno uporabo; neuporabljeno raztopino zavrzite.
Injury poisoning, and procedural complications Common: 
Poškodbe zastrupitve in zapleti pri posegih Pogoste:
PhotoBarr should not be used during pregnancy unless clearly necessary. 
PhotoBarra ne smete uporabljati med nosečnostjo, razen v nujnih primerih.
o Patients should avoid being exposed to light for 60-90 days post-exposure. 
o Bolniki se ne smejo izpostavljati svetlobi 60-90 dni po injiciranju.
There are no clinical data on exposed pregnancies available for porfimer sodium. 
Kliničnih podatkov o izpostavljenosti nosečnic porfimer-natriju ni na voljo.
Porfimer sodium should not be used during pregnancy, unless clearly necessary. 
Porfimer-natrij se ne sme uporabljati med nosečnostjo, razen če je to nujno potrebno.
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). 
Odstotek bolnikov, pri katerih se je razvil rak, je bil v skupini, zdravljeni s PhotoBarrom PDT + OM, statistično pomembno nižji kot v skupini, zdravljeni zgolj z OM (p=0,0060).
Pleural effusion, pharyngitis, atelectasis, dyspnoea 
Plevralni izliv, faringitis, atelektaza, dispneja
o they have suspected erosions of major blood vessels. 
o če imajo razjedo (erozijo) velikih krvnih žil.
A dark red to reddish brown lyophilised powder or cake. 
Temno rdeč do rdečkastorjav liofiliziran prašek ali pogača.
− Any unused product or waste material should be disposed of in accordance with local requirements. 
− Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
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. 
Od snovi, ki udušijo aktivne vrste kisika, ali sproščajo radikale, kot so dimetilsulfoksid, b-karoten, etanol, format in manitol, bi pričakovali, da zmanjšajo delovanje PDT.
You will be given a sedative along with a local anaesthetic to minimise discomfort. 
Za zmanjšanje nelagodja boste dobili pomirjevalo skupaj z lokalnim anestetikom.
Of the serious adverse events (SAEs) in the PhotoBarr PDT + OM group, 44 (23.1%) were considered associated with the treatment. 
Od hudih neželenih učinkov (HNU) v skupini bolnikov, ki so dobivali PhotoBarr PDT + OM, se je štelo, da jih je 44 (23,1%) nastalo kot posledica zdravljenja.
Breastfeeding should be terminated prior to treatment. 
Pred začetkom zdravljenja je treba prenehati dojiti.
One course of PDT consists of one injection of PhotoBarr plus one or two laser light applications. 
En ciklus PDT sestoji iz enega injiciranja PhotoBarra ter ene ali dveh aplikacij laserske svetlobe.
Short fibre optic diffusers (< 2.5 cm) are to be used to pretreat nodules with 50 J/cm diffuser length prior to regular balloon treatment in the first laser light session or for the retreatment of "skip" areas after the first light session. 
Difuzorji s kratkimi optičnimi vlakni (< 2,5 cm) se uporabljajo za predhodno zdravljenje vozličkov pri dolžini difuzorja 50 J/cm pred rednim zdravljenjem z balonom pri prvem zdravljenju z lasersko svetlobo, ali za ponovno zdravljenje »izpuščenih« področij po prvem zdravljenju z lasersko svetlobo.
The effects of an overdose on the duration of photosensitivity are unknown. 
Ni znanih učinkov prevelikega odmerjanja na trajanje občutljivosti na svetlobo.
Nodules are to be pre-treated at a light doses of 50 J/cm of diffuser length with a short (< 2.5 cm) fibre optic diffuser placed directly against the nodules followed by standard balloon application as described above. 
Vozliče je treba predhodno zdraviti z odmerki svetlobe 50 J/cm dolžine difuzorja z difuzorjem s kratkimi (< 2,5 cm) optičnimi vlakni, nameščenim neposredno na vozličih, čemur sledi standardna uporaba balona, kot je opisano zgoraj.
a Whenever possible, the BO segment selected for treatment should include normal tissue margins of a few millimetres at the proximal and distal ends. 
Kadar je mogoče, mora segment BP, izbran za zdravljenje, vključevati običajne robove tkiv nekaj milimetrov na proksimalnih in distalnih koncih.
Light intensity (mW/cm) 
Jakost svetlobe (mW/cm)
Fibre optic power outputs and treatment times required to deliver 130 J/cm of diffuser length using the centring balloon 
Izhodne moči difuzorjev z optičnimi vlakni in časi zdravljenja, potrebni za dajanje 130 J/cm dolžine difuzorja z uporabo balona za centriranje
Read the package leaflet before use. 
Pred uporabo preberite navodilo.
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. 
75 mg-vialo PhotoBarra je treba pripraviti z 31,8 ml 5% raztopine glukoze za injiciranje, katere rezultat je končna koncentracija porfimer-natrija v raztopini za injiciranje 2,5 mg/ml.
PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection. 
FARMACEVTSKA OBLIKA IN VSEBINA Prašek za raztopino za injiciranje.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 75 mg 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 75 mg
Laser light treatment: 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). 
Zdravljenje z lasersko svetlobo: Zdravnik vam bo z endoskopom (pripravo, ki se uporablja za vpogled v določene dele telesa) apliciral rdečo lasersko svetlobo (ne vročega laserja) na zadevno mesto.
HOW TO USE PHOTOBARR 
KAKO UPORABLJATI ZDRAVILO PHOTOBARR
15 mg powder in a vial (glass type I, 7 ml capacity) with a grey butyl stopper. 
15 mg praška v viali (steklo hidrolitske skupine I, prostornina 7 ml) s sivim butilnim zamaškom.
Basal cell carcinoma, lentigo Blood and lymphatic system disorders Uncommon: 
Bazalni celični karcinom, lentigo Bolezni krvi in limfatičnega sistema Občasne:
Porfimer sodium is cleared slowly from the body, with a mean CLT of 0.859 ml/h/kg (C.V. 53%) in patients. 
Porfimer-natrij se pri bolnikih počasi izčisti iz telesa, pri čemer je CLT 0,859 ml/h/kg (C.V.
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. 
15 mg-vialo PhotoBarra je treba pripraviti s 6,6 ml 5% raztopine glukoze za injiciranje, katere rezultat je končna koncentracija porfimer-natrija v raztopini za injiciranje 2,5 mg/ml.
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. 
Priporočeni odmerek zdravila 2 mg/kg, namesto priporočenega enkratnega odmerka, dan dvakrat (10 bolnikom) v razmaku dveh dni, in trikrat 2 mg/kg (1 bolniku) v času dveh tednov, so bolniki prenašali brez opaznih neželenih učinkov.
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. 
Ti rezultati potrjujejo rezultate, opažene po najmanj 6-mesečnem kontrolnem pregledu, ki je pokazal ablacijo HGD pri 72% bolnikov v skupini, zdravljeni s PhotoBarrom PDT + OM, v primerjavi z 31% bolnikov v skupini, zdravljeni zgolj z OM.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton - 15 mg 
PODATKI NA ZUNANJI OVOJNINI Karton - 15 mg
75 mg powder in a vial (glass type I, 40 ml capacity) with a grey butyl stopper. 
75 mg praška v viali (steklo hidrolitske skupine I, prostornina 40 ml ) s sivim butilnim zamaškom.
Very common side effects fever photosensitivity reactions (see section 3) vomiting, nausea tightening of the gullet (oesophagus), difficulty in swallowing that may cause pain constipation, dehydration 
Zelo pogosti neželeni učinki vročina, fotosenzitivni odzivi (glejte poglavje 3), bruhanje, slabost, zoženje požiralnika, težave pri požiranju, ki je lahko boleče, zaprtje, dehidracija.
Treated Barrett's Mucosa Length (cm) 
Dolžina sluznice zdravljenega Barrettovega požiralnika (cm)
Before you use PhotoBarr 3. 
Kaj morate vedeti, preden boste uporabili zdravilo PhotoBarr 3.
− Record the patient's skin type and the date of injection on the patient alert card 
− V bolnikovo kontrolno izkaznico vnesite tip kože in datum injiciranja zdravila.
You will be given a sedative along with a local anaesthetic, to minimise discomfort 
Za zmanjšanje nelagodja boste dobili pomirjevalo skupaj z lokalnim anestetikom
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton - 75 mg 
PODATKI NA ZUNANJI OVOJNINI Karton - 75 mg
You should stop breast-feeding before using PhotoBarr. 
Pred uporabo PhotoBarra prenehajte dojiti.
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). 
Vpliv ledvične in jetrne okvare na izpostavljenost porfimer-natriju ni bil ocenjen (glejte poglavja 4.2, 4.3 in 4.4).
Tracheo-oesophageal fistula, Gastrointestinal necrosis Skin and subcutaneous tissue disorders 
Traheoezofagenalna fistula, gastrointestinalna nekroza
PHARMACEUTICAL FORM Powder for solution for injection. 
FARMACEVTSKA OBLIKA Prašek za raztopino za injiciranje.
Treatment time (min:sec) 
Čas zdravljenja (min:sek)