FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Bulgarian: 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.
English: Also, whenever possible, the BO segment selected for the first light applications should include normal tissue margin of a few millimetre at the proximal and distal ends.
Bulgarian: a Kadar je mogoče, mora segment BP, izbran za zdravljenje, vključevati običajne robove tkiv nekaj milimetrov na proksimalnih in distalnih koncih.
English: Keep this leaflet.
Bulgarian: oči si zavarujte
English: PhotoBarr is contraindicated in patients with severe hepatic impairment.
Bulgarian: PhotoBarr je kontraindiciran pri bolnikih
English: For this treatment, the fibre optic diffuser is used without a balloon, and a light intensity of 400 mW/cm should be used.
Bulgarian: Za to zdravljenje se uporablja difuzor z optičnimi vlakni brez balona ter moč svetlobe 400 mW/cm. V
English: Efficacy and especially safety of PDT with PhotoBarr have not been established in patients with contraindications to, or not being eligible for, oesophagectomy.
Bulgarian: Učinkovitost in predvsem varnost PDT s PhotoBarrom ni bila ugotovljena pri bolnikih
English: Porfimer sodium should not be used during pregnancy, unless clearly necessary.
Bulgarian: sme uporabljati med nosečnostjo, razen če je to nujno potrebno.
English: 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).
Bulgarian: in jetrne okvare na izpostavljenost porfimer-natriju ni bil ocenjen (glejte poglavja 4.2, 4.3 in 4.4).
English: Hydrochloric acid, sodium hydroxide (for pH adjustment).
Bulgarian: Klorovodikova kislina, natrijev hidroksid (za uravnavanje pH-vrednosti).
English: Progression to cancer was related to the number of PDT courses administered.
Bulgarian: s številom opravljenih ciklusov PDT.
English: In the clinical studies with PhotoBarr, follow-up surveillance was done every three months, or every six months after four consecutive biopsy results had shown no more high-grade dysplasia (see section
Bulgarian: spremljevalni kontrolni pregled vsake tri mesece ali celo vsakih šest mesecev po tem, ko rezultati štirih zaporednih biopsij niso več pokazali
English: 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).
Bulgarian: s PhotoBarrom PDT + OM (omeprazol), s skupino bolnikov (n=183), ki so dobivali samo OM (n=70).
English: − Patients should inform their doctor before they start treatment if they have severe o Remains in your body for 60-90 days after receiving the injection 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 o Commercially available sun blocks are not effective in preventing sensitivity due to light
Bulgarian: − Bolniki morajo zdravnika pred pričetkom zdravljenja obvestiti o morebitni hudi o Obstaja velika nevarnost nastanka fotosenzitivnih reakcij (preobčutljivosti na o Na izpostavljeni koži se lahko pojavi rdečina, ki v večini primerov pozroča nelagodje in se lahko razvije v hudo preobčutljivost na svetlobo.
English: 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).
Bulgarian: s PhotoBarrom PDT + OM, statistično pomembno nižji kot v skupini, zdravljeni zgolj z OM (p=0,0060).
English: Photodynamic therapy with PhotoBarr should be performed only by, or under the supervision of, a physician with experience in endoscopic laser procedures.
Bulgarian: s PhotoBarrom mora opraviti zdravnik, ki ima izkušnje z endoskopskimi laserskimi postopki oz.
English: Pulmonary or cardiac disorders
Bulgarian: Bolezni pljuč in srca
English: Patients with BO > 7 cm, should have the remaining untreated length of Barrett's epithelium treated with a second PDT course at least 90 days later.
Bulgarian: Način dajanja odmerkov je na kratko prikazan v Preglednici 4. Pri bolnikih z BP > 7 cm je treba preostalo nezdravljeno dolžino epitelija Barrettovega požiralnika zdraviti z drugim ciklusom PDT najmanj
English: - Tracheo-oesophageal or broncho-oesophageal fistula.
Bulgarian: - Fistule sapnika in požiralnika ali fistule bronhijev in požiralnika.
English: Joint contracture, joint range of motion decreased, musculoskeletal chest pain,
Bulgarian: Kontraktura sklepa, zmanjšani obseg gibljivosti sklepa, mišično-kostna
English: 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.
Bulgarian: s 6,6 ml 5% raztopine glukoze za injiciranje, katere rezultat je končna koncentracija porfimer-natrija v raztopini za injiciranje 2,5 mg/ml.
English: CLINICAL PARTICULARS
Bulgarian: V kliničnih raziskavah
English: Table 2.
Bulgarian: V preglednici 2
English: A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Bulgarian: ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Bulgarian: Tega zdravila ne smemo mešati z drugimi zdravili, razen
English: PhotoBarr PDT causes direct intracellular damage by initiating radical chain reactions that damage intracellular membranes and mitochondria.
Bulgarian: s tem, da sproži radikalne verižne reakcije, ki poškodujejo membrane
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 75 mg porfimer sodium.
Bulgarian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 75 mg porfimer-natrija.
English: Choking, dyspnoea exertional, haemoptysis, hypoxia, nasal congestion, pneumonia aspiration, productive cough, respiratory depression, respiratory
Bulgarian: Dušenje, oteženo dihanje po naporu, hemoptiza, hipoksija, nazalna kongestija, aspiracijska pljučnica, produktivni kašelj, respiratorna depresija, kongestija
English: After reconstitution, protect from light and use within 3 hours.
Bulgarian: Po pripravi zaščitite zdravilo pred svetlobo in uporabite v 3 urah.
English: The active substance is porfimer sodium.
Bulgarian: - Zdravilna učinkovina je porfimer-natrij.
English: Healthcare professionals administration and monitoring guide
Bulgarian: Navodila za zdravstveno osebje za odmerjanje zdravila in spremljanje zdravljenja
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 15 mg porfimer sodium.
Bulgarian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 15 mg porfimer-natrija.
English: The influence of hepatic impairment on exposure to porfimer sodium has not been evaluated (see section 4.3 and 4.4).
Bulgarian: Vpliv jetrne okvare na izpostavljenost porfimer-natriju ni bil ocenjen (glejte poglavji 4.3 in 4.4).
English: Patient guide − Brief background and introduction to Barrett's oesophagus and high grade
Bulgarian: − Kratek opis in razlaga Barretovega požiralnika ter visoke stopnje displazije
English: Oesophageal Stenosis
Bulgarian: Stenoza požiralnika
English: o Patients should avoid being exposed to light for 60-90 days post-exposure.
Bulgarian: o Bolnike je potrebno seznaniti z daljšim razpolovnim časom porfirinov in o o Bolniki se ne smejo izpostavljati svetlobi 60-90 dni po injiciranju.
English: 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.
Bulgarian: s kratkimi (< 2,5 cm) optičnimi vlakni, nameščenim neposredno na vozličih, čemur sledi standardna uporaba balona, kot je opisano zgoraj.
English: Angina pectoris, atrial fibrillation, atrial flutter, chest discomfort Vascular disorders
Bulgarian: Angina pektoris, atrijska fibrilacija, atrijska undulacija, pritisk v prsih
English: Patients with mild to moderate hepatic impairment should be clearly instructed that the period requiring the precautionary measures described below may be longer than 90 days.
Bulgarian: Bolnikom z blago do zmerno okvaro jeter je treba jasno razložiti, da je lahko obdobje, v katerem
English: Non Cardiac Chest Pain
Bulgarian: Nekardiogena prsna bolečina
English: Very common: Photosensitivity reaction Common:
Bulgarian: Bolezni kože in podkožja Zelo pogoste: Fotosenzitivna reakcija Pogoste:
English: If intake of food and/or drink becomes impossible or repeated vomiting occurs, patients should be advised to return to the clinic for evaluation and to receive intravenous fluids if needed.
Bulgarian: Če postane zaužitje hrane in/ali pijače nemogoče, ali če se bruhanje ponavlja, je treba bolnikom
English: − It is important that patients tell their doctor if they get exposed to sunlight after receiving treatment with PhotoBarr.
Bulgarian: − Pomembno je, da bolniki opozorijo zdravnika, če so bili po zdravljenju
English: Marketing Authorisation Holder
Bulgarian: IMETNIK DOVOLJENJA
English: 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.
Bulgarian: Izogniti se je treba profilaktični uporabi kortikosteroidov, da bi zmanjšali nastanek strikture med zdravljenjem
English: The other ingredients are hydrochloric acid and/or sodium hydroxide (for pH adjustment).
Bulgarian: Po pripravi - Ostale učinkovine so klorovodikova kislina in/ali natrijev hidroksid (za uravnavanje pH
English: The light dose (J/cm)= power output from diffuser (W) x treatment time (sec)
Bulgarian: Da bi izračunali odmerek svetlobe, se za vse difuzorje z optičnimi vlakni uporablja naslednja posebna odmerek svetlobe (J/cm) = izhodna moč iz difuzorja (W) x čas zdravljenja (sek)
English: Medicinal products that decrease clotting, vasoconstriction or platelet aggregation, e.g., thromboxane A2 inhibitors, could decrease the efficacy of PDT.
Bulgarian: inhibitorji tromboksana A2, bi lahko zmanjšali učinkovitost PDT.
English: NAME OF THE MEDICINAL PRODUCT PhotoBarr 15 mg powder for solution for injection
Bulgarian: IME ZDRAVILA PhotoBarr 15 mg prašek za raztopino za injiciranje
English: NA
Bulgarian: dan
English: 3, 5 or 7 cm balloon (130 J/cm)
Bulgarian: (130 J/cm)
English: Paediatric patients
Bulgarian: Zdravljenje bolnikov
English: 15 mg powder in a vial (glass type I, 7 ml capacity) with a grey butyl stopper.
Bulgarian: 15 mg praška v viali (steklo hidrolitske skupine I, prostornina 7 ml)
English: Each vial contains 15 mg of porfimer sodium.
Bulgarian: Ena viala vsebuje 15 mg porfimer-natrija.
English: Special populations
Bulgarian: Posebne skupine bolnikov
English: Pruritus, rash, skin fragility, skin discolouration, skin ulcer, dermatitis exfoliative, dry skin, milia, rash maculo-papular, rash papular, scar, skin hyperpigmentation, skin lesion, skin nodule, urticaria
Bulgarian: Pruritus, kožni izpuščaj, krhkost kože, obarvanje kože, razjeda na koži, eksfoliativni dermatitis, suha koža, kožni izpuščaj, makulo-papulozni izpuščaj, papulozni izpuščaj, brazgotina, hiperpigmentacija kože, razjeda na koži, živčni vozlički na koži, urtikarija.
English: if none of these appear on the exposed area, then you can gradually return to your normal outdoor activities, limiting exposure to the sun during the midday hours.
Bulgarian: Če se ti znaki ne pojavijo, lahko postopno začnete opravljati običajne dejavnosti na prostem in
English: NAME OF THE MEDICINAL PRODUCT PhotoBarr 75 mg powder for solution for injection.
Bulgarian: IME ZDRAVILA PhotoBarr 75 mg prašek za raztopino za injiciranje.
English: Forty-one percent of patients showed normal squamous cell epithelium and 49% had absence of dysplasia.
Bulgarian: 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
English: Each vial contains 75 mg of porfimer sodium.
Bulgarian: Ena viala vsebuje 75 mg porfimer-natrija.
English: However, because of its potential to induce photosensitivity, PhotoBarr might be an eye and/or skin irritant in the presence of bright light.
Bulgarian: PhotoBarr lahko draži oči in/ali kožo na močni svetlobi, ker lahko povzroči fotosenzitivnost.
English: Frequency not known side effects lung infection lower number of red cells in your blood cataract lesion in intestine, abnormal opening between the wind pipe and the food pipe allergic reaction blood clots in your vessels, blockage of blood arteries, inflammation of a vein
Bulgarian: - razjeda na črevesju, nenormalna odprtina med sapnikom in požiralnikom - krvni strdki v žilah, blokada arterij, vnetje vene
English: Feeling hot, injection site erythema, lethargy, malaise, oedema peripheral, pain, pitting oedema, temperature intolerance, weakness
Bulgarian: Občutek vročine, rdečina na mestu injiciranja, letargija, slabost, periferni edem, bolečina, edem vdolbinice, neprenašanje toplote, oslabelost
English: Photodynamic therapy (PDT) with PhotoBarr is indicated for ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO).
Bulgarian: s PhotoBarrom je indicirano v primeru odprave displazije visoke stopnje (HGD, high-grade dysplasia) pri bolnikih z Barrettovim
English: 4.8 Undesirable effects a. Summary of the safety profile
Bulgarian: Preglednica 5. Povzetek neželenih učinkov
English: Light intensity (mW/cm)
Bulgarian: svetlobe 400 mW/cm
English: The other ingredients are hydrochloric acid and sodium hydroxide (for pH adjustment).
Bulgarian: Po pripravi - Ostale učinkovine so klorovodikova kislina in natrijev hidroksid (za uravnavanje pH-vrednosti).
English: One or 2 laser light treatments were administered following PhotoBarr injection.
Bulgarian: Po injiciranju PhotoBarra je sledilo eno do 2 zdravljenji z lasersko svetlobo.
English: Balloon Window Length (cm)
Bulgarian: Velikost odprtine za balon (cm)
English: How to prevent a photosensitivity reaction
Bulgarian: s pomočjo fotobelilne reakcije.
English: OTHER
Bulgarian: Poleg
English: As measured by immersing the diffuser into the cuvette in the power meter and slowly increasing the laser power.
Bulgarian: in ob postopnem povečevanju moči laserja.
English: Hypersensitivity
Bulgarian: Občutljivost na svetlobo
English: 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).
Bulgarian: PhotoBarr PDT + OM je učinkovito odpravil HGD pri bolnikih z BP. V končni analizi, opravljeni po najmanj 24-mesečnem obdobju spremljanja in izvajanja kontrolnih pregledov, je statistično pomemben odstotek bolnikov (77%) v skupini, ki je dobivala PhotoBarr PDT + OM, pokazal popolno ablacijo
English: − Area in card for physician to record skin type and date of injection.
Bulgarian: izkaznici je predviden prostor, v katerega zdravnik vnese tip kože in
English: Laser treatment should not be given if an overdose of PhotoBarr is administered.
Bulgarian: sme uporabiti, če je bil dan prevelik odmerek PhotoBarra.
English: Tumour and dysplastic tissue selectivity in treatment may occur partly through selective retention of porfimer sodium but mainly through a selective delivery of light.
Bulgarian: Selektivnost tumorjev in displastičnega tkiva pri zdravljenju lahko delno nastane
English: Uptake of photosensitiser
Bulgarian: Absorpcija v fotosenzibilizatorju svetlobe
English: For any information about this medicine, please contact the Marketing Authorisation Holder.
Bulgarian: Za vse nadaljnje informacije o tem zdravilu
English: Photoactivation is controlled by the total light dose delivered.
Bulgarian: s celotnim uporabljenim odmerkom svetlobe.
English: In case of persistence of HGD, further treatment courses (up to a maximum of three courses) may be given (separated by a minimum of 90 days) to increase the response rate.
Bulgarian: V primeru trdovratne HGD je možno nadaljnje zdravljenje (do največ treh ciklusov) (v razmaku najmanj 90 dni), da se poveča odstotek odzivov. To je treba pretehtati glede na povečano stopnjo nastanka strikture (glejte poglavje 4.8 ter poglavje 5.1).
English: The recommended dose of PhotoBarr is 2 mg/kg body weight.
Bulgarian: s PDT, so dobivali PhotoBarr v odmerku 2 mg/kg telesne mase
English: PhotoBarr Injection
Bulgarian: Fotodinamično zdravljenje
English: Porphyria.
Bulgarian: PhotoBarra.
English: Common:
Bulgarian: Občasne:
English: Tell your doctor immediately: if you notice a change in your eyesight.
Bulgarian: svojega zdravnika, če se pojavi kar koli od naštetega:
English: Do not store above 25°C.
Bulgarian: s skupno zmogljivostjo, ki ne presega 2,5 W.
English: BEFORE YOU USE PHOTOBARR
Bulgarian: Po pripravi je PhotoBarr
English: 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.
Bulgarian: ter 14% v skupini, ki je dobivala samo OM (p<0,0001). Ti rezultati potrjujejo rezultate, opažene po najmanj 6-mesečnem kontrolnem pregledu, ki je pokazal ablacijo HGD pri 72% bolnikov v skupini, zdravljeni
English: − It is important to follow exactly the correct steps for reconstitution and administration of porfimer.
Bulgarian: slediti korakom za pripravo in odmerjanje.
English: Pharmacotherapeutic group: Sensitizers used in photodynamic/radiation therapy, ATC code: L01XD01
Bulgarian: Farmakoterapevtska skupina: Senzibilizatorji, ki se uporabljajo za fotodinamično/obsevalno
English: Back pain, pain in the limb
Bulgarian: - bolečine v hrbtu, bolečine v okončinah, bolečina, ki je posledica zdravljenja.
English: POSSIBLE SIDE EFFECTS
Bulgarian: Vpliv ledvične
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial 75 mg - 40 ml
Bulgarian: Viala 75 mg - 40 ml
English: PHARMACEUTICAL PARTICULARS
Bulgarian: Podrobne informacije o zdravilu
English: The first stage is the intravenous injection of PhotoBarr.
Bulgarian: s PhotoBarrom je 2-stopenjski proces. Prva stopnja je intravensko injiciranje PhotoBarr.
English: − Patients should NOT be treated with porfimer if:
Bulgarian: − Bolnikom je treba pojasniti, da morajo
English: One patient experienced life-threatening dyspnoea and the others had no notable complications.
Bulgarian: Pri enem bolniku se je pojavila smrtno nevarna dispneja, pri drugih pa ni bilo večjih težav. Po prevelikem odmerku svetlobe se lahko pričakuje povečano število
English: Other less common skin manifestations were reported in areas where photosensitivity reactions had occurred, such as increased hair growth, skin discolouration, skin nodules, skin wrinkling and skin fragility.
Bulgarian: so poročali na področjih, kjer so se pojavile preobčutljivostne reakcije, kot so večja poraščenost, obarvanje kože, vozlički v koži, nagubanje kože in krhkost kože. Te pojave lahko pripišemo stanju psevdoporfirije (trenutna kožna porfirija, ki nastane zaradi zravila).
English: PACKAGE LEAFLET: INFORMATION FOR THE USER PhotoBarr 15 mg powder for solution for injection Porfimer sodium
Bulgarian: NAVODILO ZA UPORABO PhotoBarr 15 mg prašek za raztopino za injiciranje Porfimer-natrij
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial 15 mg - 7 ml
Bulgarian: Viala 15 mg - 7 ml
English: PACKAGE LEAFLET: INFORMATION FOR THE USER PhotoBarr 75 mg powder for solution for injection Porfimer sodium
Bulgarian: NAVODILO ZA UPORABO PhotoBarr 75 mg prašek za raztopino za injiciranje Porfimer-natrij
English: Musculoskeletal and connective tissue disorders Common:
Bulgarian: s pofrimer-natrijem Infekcijske in parazitske bolezni Občasne:
English: What PhotoBarr looks like and contents of the pack PhotoBarr is a reddish brown powder for solution for injection.
Bulgarian: PhotoBarr je rdečkastorjav prašek za raztopino za injiciranje.
English: Table 2 provides the settings that would be used to deliver the dose within the shortest time (light intensity of 270 mW/cm).
Bulgarian: se nahajajo nastavitve, ki se morajo uporabljati za dajanje odmerka v najkrajšem času (jakost svetlobe 270 mW/cm). Po potrebi je dodana še druga možnost (jakost svetlobe 200 mW/cm) za prilagoditev laserjev
English: Photosensitivity skin test
Bulgarian: Absorpcija v fotosenzibilizatorju Fotoaktivacija
English: Day 5
Bulgarian: s 7%
English: Lactation
Bulgarian: Bolezni
English: Basal cell carcinoma, lentigo Blood and lymphatic system disorders Uncommon:
Bulgarian: Bazalni celični karcinom, lentigo
English: Co-administration of omeprazole (20 mg BID) began at least 2 days before PhotoBarr injection.
Bulgarian: se je začela najmanj 2 dni pred injiciranjem PhotoBarra.
English: Cold sweat, dermatitis, hair growth abnormal, increased tendency to bruise, keloid scar, night sweats, photosensitive rash, rash macular, rash scaly, scab,
Bulgarian: Mrzel pot, dermatitis, neobičajna poraščenost, večje nagnjenje k podplutbam, keloidna brazgotina, nočno potenje, izpuščaj, ki nastane kot posledica izpostavljenosti svetlobi, makularni izpuščaj, luskasti izpuščaj, krastavost,
English: Pharmacovigilance Plan or risk minimisation activities
Bulgarian: izračun bodisi medicinskega izdelka bodisi odmerka
English: nausea*
Bulgarian: s temnimi
English: You should stop breast-feeding before using PhotoBarr.
Bulgarian: KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO PHOTOBARR
English: Porfimer sodium2.
Bulgarian: s PhotoBarrom PDT.
English: Renal impairment The influence of renal impairment on exposure to porfimer sodium has not been evaluated (see section
Bulgarian: Vpliv ledvične okvare na izpostavljenost PhotoBarru ni bil ocenjen (glejte poglavje 4.3).
English: If you miss the laser light treatment
Bulgarian: Lasersko zdravljenje se ne
English: Clinical efficacy
Bulgarian: V nadzorovanem kliničnem preskušanju
English: aAs measured by immersing the diffuser into the cuvette in the power meter and slowly increasing the laser power.
Bulgarian: s potopitvijo difuzorja v kiveto v merilniku jakosti
English: In this leaflet:
Bulgarian: Opomba:
English: You will be given a sedative along with a local anaesthetic, to minimise discomfort
Bulgarian: skupaj z lokalnim anestetikom
English: Uncommon:
Bulgarian: Neznana:
English: PhotoBarr PDT plus omeprazole (PDT + OM) treatment was compared to a group treated with omeprazole alone (OM only), in the BO with HGD controlled clinical trial.
Bulgarian: V nadzorovanem kliničnem preskušanju so primerjali skupino bolnikov (n=183), zdravljenih s PhotoBarrom PDT + OM (omeprazol), s skupino bolnikov (n=70), ki so dobivali samo OM. Bolniki, primerni za to raziskavo, so morali imeti z biopsijo potrjeno HGD v Barrettovem požiralniku (BP).
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Bulgarian: Imetnik dovoljenja za promet z zdravilom se mora o podrobnostih glede izobraževalnega gradiva dogovoriti
English: - Porphyria.
Bulgarian: Porfimer-natrij se ne
English: Common side effects back pain, pain in arms and legs, pain due to treatment headache, feeling nervous, tingling feeling, problems sleeping abdominal stiffness, stomach pain, vomiting blood disorders of the gullet such as ulcer, irritation or constriction loose stools, passing dark tarry stool, sore throat, hiccups, belching fluid in chest, chest pain, fast heart beat, shortness of breath, shakes due to high fever, chills loss of weight, decrease in appetite, feeling tired, loss of taste skin ulcer, rash, itchiness, hives, change in skin colour, scratch, scar, abnormal tissue, bump on the skin, very small cysts in the skin, dry and fragile skin
Bulgarian: - razjeda na koži, kožni izpuščaj, srbečica, koprivnica, sprememba barve kože, majhne kožne ranice, brazgotina, nenormalno tkivo, kožne bule, zelo majhne kožne ciste, suha in krhka koža.
English: EXPIRY DATE
Bulgarian: Zahtevana izhodna