FrancophonIA/ELRC3.0 huggingface dataset:
English: 15 mg powder in a vial (glass type I, 7 ml capacity) with a grey butyl stopper.
Slovenian: 15 mg praška v viali (steklo hidrolitske skupine I, prostornina 7 ml) s sivim butilnim zamaškom.
English: Basal cell carcinoma, lentigo Blood and lymphatic system disorders Uncommon:
Slovenian: Bazalni celični karcinom, lentigo Bolezni krvi in limfatičnega sistema Občasne:
English: Porfimer sodium is cleared slowly from the body, with a mean CLT of 0.859 ml/h/kg (C.V. 53%) in patients.
Slovenian: Porfimer-natrij se pri bolnikih počasi izčisti iz telesa, pri čemer je CLT 0,859 ml/h/kg (C.V.
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.
Slovenian: 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.
English: 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.
Slovenian: 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.
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.
Slovenian: 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.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton - 15 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI Karton - 15 mg
English: 75 mg powder in a vial (glass type I, 40 ml capacity) with a grey butyl stopper.
Slovenian: 75 mg praška v viali (steklo hidrolitske skupine I, prostornina 40 ml ) s sivim butilnim zamaškom.
English: 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
Slovenian: Zelo pogosti neželeni učinki vročina, fotosenzitivni odzivi (glejte poglavje 3), bruhanje, slabost, zoženje požiralnika, težave pri požiranju, ki je lahko boleče, zaprtje, dehidracija.
English: Treated Barrett's Mucosa Length (cm)
Slovenian: Dolžina sluznice zdravljenega Barrettovega požiralnika (cm)
English: Before you use PhotoBarr 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo PhotoBarr 3.
English: − Record the patient's skin type and the date of injection on the patient alert card
Slovenian: − V bolnikovo kontrolno izkaznico vnesite tip kože in datum injiciranja zdravila.
English: You will be given a sedative along with a local anaesthetic, to minimise discomfort
Slovenian: Za zmanjšanje nelagodja boste dobili pomirjevalo skupaj z lokalnim anestetikom
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton - 75 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI Karton - 75 mg
English: You should stop breast-feeding before using PhotoBarr.
Slovenian: Pred uporabo PhotoBarra prenehajte dojiti.
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).
Slovenian: Vpliv ledvične in jetrne okvare na izpostavljenost porfimer-natriju ni bil ocenjen (glejte poglavja 4.2, 4.3 in 4.4).
English: Tracheo-oesophageal fistula, Gastrointestinal necrosis Skin and subcutaneous tissue disorders
Slovenian: Traheoezofagenalna fistula, gastrointestinalna nekroza
English: PHARMACEUTICAL FORM Powder for solution for injection.
Slovenian: FARMACEVTSKA OBLIKA Prašek za raztopino za injiciranje.
English: Treatment time (min:sec)
Slovenian: Čas zdravljenja (min:sek)
English: Patients may receive a second laser light application 96-120 hours after administration.
Slovenian: Bolniki lahko prejmejo drugi odmerek laserske svetlobe 96-120 ur po dajanju zdravila.
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).
Slovenian: 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 HGD v primerjavi z 39% bolnikov v skupini, zdravljeni samo z OM (p<0,0001).
English: Treatment time (sec)
Slovenian: Čas zdravljenja (sek)
English: - Oesophageal or gastric varices or patients with oesophageal ulcers >1 cm in diameter.
Slovenian: - Varice požiralnika ali želodca ali bolniki z razjedami požiralnika premera >1 cm.
English: Photosensitivity skin test
Slovenian: Kožni preskus preobčutljivosti na svetlobo
English: Take special care with PhotoBarr Tell your doctor if any of the following applies to you: you are taking any other medicines (see below), you have a liver or kidney problems you have a family history of cataracts you are 75 years or older, you have or have had heart or lung disease
Slovenian: Bodite posebno pozorni pri uporabi zdravila PhotoBarr Obvestite svojega zdravnika, če se pojavi kar koli od naštetega: kadar jemljete druga zdravila (glejte spodaj), če imate težave z jetri ali ledvicami, če imate očesno mreno v družinski anamnezi, če ste stari 75 let ali več, če imate ali ste imeli resno bolezen srca ali pljuč.
English: The cytotoxic actions of porfimer sodium are light and oxygen-dependent.
Slovenian: Citotoksični učinki porfimer-natrija so blagi in odvisni od kisika.
English: Name and address of the manufacturer responsible for batch release Axcan Pharma SAS
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Axcan Pharma International B.V.
English: o Patients should be instructed to seek medical advice if signs/symptoms suggestive of photosensitivity occur during or after therapy with porfimer.
Slovenian: o Bolnike je treba poučiti, da se v primeru, da se med ali po zdravljenju s porfirini pojavijo fotosenzitivne reakcije, posvetujejo z zdravnikom.
English: − Photosensitivity can only be prevented by avoiding exposure to the sun for 90 days after receiving the PhotoBarr injection
Slovenian: − Fotosenzitivne reakcije se lahko preprečijo samo, če se izognete izpostavljenosti kože in oči svetlobi v obdobju 90 dni po injekciji PhotoBarra.
English: One course of PDT consists of one injection plus one or two light applications.
Slovenian: En ciklus PDT se sestoji iz enega injiciranja PhotoBarra ter ene ali dveh aplikacij svetlobe.
English: All patients who receive PhotoBarr will be photosensitive (sensitive to light) and must observe precautions to avoid direct sunlight and bright indoor light (see above ‘How to prevent a photosensitivity reaction').
Slovenian: Vsi bolniki, ki dobivajo PhotoBarr, so fotosenzitivni (občutljivi na svetlobo) in morajo upoštevati posebna opozorila, da se izognejo neposredni sončni svetlobi in močni notranji svetlobi (glejte zgoraj 'Kako preprečimo fotosenzitivne reakcije').
English: PhotoBarr Injection
Slovenian: Injiciranje PhotoBarra
English: A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
English: Diffuser length (cm)
Slovenian: Dolžina difuzorja (cm)
English: Blood albumin decreased, blood chloride increased, blood urea increased, haematocrit decreased, haemoglobin decreased, oxygen saturation decreased,
Slovenian: Zmanjšana vrednost krvnega albumina, zvišana vrednost klorida v krvi, zvišana vrednost sečnine v krvi, zmanjšana vrednost hematokrita, zmanjšana vrednost hemoglobina, manjša nasičenost s kisikom, manjša vrednost skupnih
English: Table 3 lists appropriate fibre optic power outputs and treatment times using a light intensity of 400 mW/cm.
Slovenian: V Preglednici 3 so naštete ustrezne izhodne moči difuzorjev z optičnimi vlakni ter časi zdravljenja pri uporabljeni jakosti svetlobe 400 mW/cm.
English: Photodynamic therapy with PhotoBarr should be performed only by, or under the supervision of, a physician with experience in endoscopic laser procedures.
Slovenian: Fotodinamično zdravljenje s PhotoBarrom mora opraviti zdravnik, ki ima izkušnje z endoskopskimi laserskimi postopki oz. se lahko opravi le pod nadzorom takega zdravnika.
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
Slovenian: - okužba pljuč - manjše število rdečih krvnih celic v vaši krvi - očesna mrena - razjeda na črevesju, nenormalna odprtina med sapnikom in požiralnikom - alergijska reakcija - krvni strdki v žilah, blokada arterij, vnetje vene
English: - Hypersensitivity to the active substance, other porphyrins or to any of the excipients.
Slovenian: - Preobčutljivost za zdravilno učinkovino, druge porfirine ali katero koli pomožno snov.
English: − There are a number of potential side effects that patients should be aware of.
Slovenian: − Bolniki morajo biti seznanjenimi z možnimi neželenimi učinki.
English: affects less than 1 user in 10,000
Slovenian: prizadene manj kot 1 od 10.000 bolnikov
English: Short fibre optic diffusers to be used without a centering balloon to deliver 50 J/cm of diffuser length at a light intensity of 400 mW/cm
Slovenian: Difuzorji z majhno dolžino optičnih vlaken, ki se uporabljajo brez centrirnega balona za oddajanje 50 J/cm dolžine difuzorja pri jakosti svetlobe 400 mW/cm
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.
Slovenian: Zdravljenje bolnikov s PhotoBarrom PDT in omeprazolom (PDT + OM) so primerjali s skupino bolnikov, zdravljenih samo z omeprazolom (samo OM) pri BP s HGD v nadzorovanem kliničnem preskušanju.
English: The laser light application will induce difficulties with swallowing (pain, nausea and vomiting).
Slovenian: Uporaba zdravila PhotoBarr skupaj s hrano in pijačo Uporaba laserske svetlobe povzroči težave pri požiranju (bolečino, slabost in bruhanje).
English: For this treatment, the fibre optic diffuser is used without a balloon, and a light intensity of 400 mW/cm should be used.
Slovenian: Za to zdravljenje se uporablja difuzor z optičnimi vlakni brez balona ter moč svetlobe 400 mW/cm.
English: Increased symptoms and damage to normal tissue might be expected following an overdose of light.
Slovenian: Po prevelikem odmerku svetlobe se lahko pričakuje povečano število simptomov in poškodba zdravega tkiva.
English: Preclinical studies indicate that the excretion of porfimer sodium components occurs primarily via the faecal route.
Slovenian: Predklinične študije kažejo, da se sestavine porfimer-natrija izločajo predvsem z blatom.
English: Laser Light Application
Slovenian: Uporaba laserske svetlobe
English: After reconstitution, each ml solution contains 2.5 mg porfimer sodium.
Slovenian: Po pripravi vsebuje vsak ml raztopine 2,5 mg porfimer-natrija.
English: General disorders and administration site conditions Very common: Pyrexia
Slovenian: Splošne težave in spremembe na mestu aplikacije Zelo pogoste: Vročica (pireksija) Pogoste:
English: affects more than 1 user in 10
Slovenian: prizadene več kot 1 od 10 bolnikov
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.
Slovenian: Kadar je možno, naj izbrani segment BP za prve uporabe (laserske) svetlobe zajema tudi običajni, nekaj milimetrski rob tkiva na proksimalnih in distalnih koncih.
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).
Slovenian: V nadzorovanem kliničnem preskušanju so primerjali skupino bolnikov, zdravljenih s PhotoBarrom PDT + OM (omeprazol), s skupino bolnikov (n=183), ki so dobivali samo OM (n=70).
English: • Healthcare professionals administration and monitoring guide
Slovenian: • Navodila za zdravstveno osebje za odmerjanje zdravila in spremljanje zdravljenja
English: Summary of adverse reactions with porfimer sodium Infections and infestations
Slovenian: Povzetek neželenih učinkov s pofrimer-natrijem Infekcijske in parazitske bolezni Občasne:
English: Choking, dyspnoea exertional, haemoptysis, hypoxia, nasal congestion, pneumonia aspiration, productive cough, respiratory depression, respiratory
Slovenian: Dušenje, oteženo dihanje po naporu, hemoptiza, hipoksija, nazalna kongestija, aspiracijska pljučnica, produktivni kašelj, respiratorna depresija, kongestija
English: In clinical trials, PhotoBarr PDT has only been tested in patients being treatment naive concerning mucosal ablative therapy.
Slovenian: V kliničnih preskušanjih PhotoBarra je bila PDT preizkušena le pri bolnikih, ki še niso bili zdravljeni z ablativnim zdravljenjem sluznice.
English: After reconstitution, protect from light and use within 3 hours.
Slovenian: Po pripravi zaščitite zdravilo pred svetlobo in uporabite v 3 urah.
English: What PhotoBarr contains The active substance is porfimer sodium.
Slovenian: Kaj vsebuje zdravilo PhotoBarr - Zdravilna učinkovina je porfimer-natrij.
English: Non Cardiac Chest Pain
Slovenian: Nekardiogena prsna bolečina
English: Uptake of photosensitiser
Slovenian: Absorpcija v fotosenzibilizatorju
English: Treatment of "skip" areas only aDiscrete nodules will receive an initial light application of 50 J/cm (using short diffuser) before the balloon light application.
Slovenian: Samo zdravljenje »izpuščenih« področij a Pri posameznih vozličih uporabimo začetni odmerek svetlobe 50 J/cm (pri difuzorju s kratkimi vlakni) pred uporabo svetlobe iz balona.
English: p/a Trust Company Amsterdam B.V.
Slovenian: Axcan Pharma International B.V.
English: Angina pectoris, atrial fibrillation, atrial flutter, chest discomfort Vascular disorders
Slovenian: Angina pektoris, atrijska fibrilacija, atrijska undulacija, pritisk v prsih
English: Pulmonary or cardiac disorders
Slovenian: Bolezni pljuč in srca
English: Follow-up procedure
Slovenian: Spremljanje postopka
English: - Tracheo-oesophageal or broncho-oesophageal fistula.
Slovenian: - Fistule sapnika in požiralnika ali fistule bronhijev in požiralnika.
English: As measured by immersing the diffuser into the cuvette in the power meter and slowly increasing the laser power.
Slovenian: Kot je bilo izmerjeno s potopitvijo difuzorja v kiveto v merilniku jakosti in ob postopnem povečevanju moči laserja.
English: The reddish-brown solution is slowly injected, over 3 to 5 minutes, into a vein.
Slovenian: Rdečkastorjavo raztopino počasi injicirajo v veno na vaši roki 3 do 5 minut.
English: Photodynamic therapy (PDT) with PhotoBarr is indicated for ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO).
Slovenian: Fotodinamično zdravljenje (PDT, photodynamic therapy) s PhotoBarrom je indicirano v primeru odprave displazije visoke stopnje (HGD, high-grade dysplasia) pri bolnikih z Barrettovim požiralnikom (BP).
English: Common:
Slovenian: Pogoste:
English: Healthcare professionals administration and monitoring guide
Slovenian: Navodila za zdravstveno osebje za odmerjanje zdravila in spremljanje zdravljenja
English: Side effects may occur with certain frequencies, which are defined as follows: Very common:
Slovenian: Razvrstitev pogostosti neželenih učinkov: Zelo pogosto:
English: aAs measured by immersing the diffuser into the cuvette in the power meter and slowly increasing the laser power.
Slovenian: Izmerjeno s potopitvijo difuzorja v kiveto v merilniku jakosti in ob postopnem povečevanju moči laserja.
English: Very common: Photosensitivity reaction Common:
Slovenian: Bolezni kože in podkožja Zelo pogoste: Fotosenzitivna reakcija Pogoste:
English: In patients, the mean peak plasma concentration (Cmax) was 79.6 μg/ml (CV 61%, range 39-222), whereas in volunteers Cmax was 40 μg/ml and AUCinf was 2400 μg/h/ml.
Slovenian: 61%, razpon 39-222), pri prostovoljcih pa je bil Cmax 40 μg/ml in AUCinf 2400 μg/h/ml.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 75 mg porfimer sodium.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 75 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).
Slovenian: Vpliv jetrne okvare na izpostavljenost porfimer-natriju ni bil ocenjen (glejte poglavji 4.3 in 4.4).
English: Do not use PhotoBarr if you are allergic (hypersensitive) to porfimer sodium, other porphyrins or any of the other ingredients of PhotoBarr (listed in section 6, ‘What PhotoBarr contains') if you have porphyria if you have an opening (fistula) between the oesophagus and the airways if you suffer from varices of your oesophageal veins or erosion of other major blood vessels if you have ulcers in your oesophagus if you have severe liver or kidney problems
Slovenian: PhotoBarra (naštetih v poglavju 6, »Kaj vsebuje zdravilo PhotoBarr«), - če imate porfirijo, - če imate odprtino (fistulo) med požiralnikom in dihalnimi potmi, - če imate varice v venah požiralnika ali razjedo (erozijo) drugih velikih krvnih žil, - če imate razjede v požiralniku, - če imate hudo motnjo v delovanju jeter ali ledvic.
English: One single-use vial per pack.
Slovenian: Viala za enkratno uporabo.
English: Hydrochloric acid, sodium hydroxide (for pH adjustment).
Slovenian: Klorovodikova kislina, natrijev hidroksid (za uravnavanje pH-vrednosti).
English: 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.
Slovenian: Do konca najmanj dveletnega obdobja kontrolnih pregledov se je rak razvil pri 13% bolnikov v skupini, zdravljeni s PhotoBarrom PDT + OM, medtem ko je bilo v skupini, zdravljeni samo z OM, v populaciji bolnikov, ki so čakali na zdravljenje (ITT), 28% takih primerov.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 15 mg porfimer sodium.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 15 mg porfimer-natrija.
English: After reconstitution, PhotoBarr is a dark red to reddish brown, opaque solution.
Slovenian: Po pripravi je PhotoBarr temno rdeča do rdečkastorjava motna raztopina.
English: Congenital and familial and genetic disorders Uncommon:
Slovenian: Vrojene, dedne in genetske okvare Občasne:
English: Light doses
Slovenian: Odmerki svetlobe
English: Photodynamic therapy (PDT) with PhotoBarr is indicated for: - ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO).
Slovenian: Fotodinamično zdravljenje (PDT, photodynamic therapy) s PhotoBarrom je indicirano v primeru odprave displazije visoke stopnje (HGD, 'high-grade dysplasia) pri bolnikih z Barrettovim požiralnikom (BP).
English: Ocular sensitivity
Slovenian: Občutljivost oči
English: However, because of its potential to induce photosensitivity, PhotoBarr might be an eye and/or skin irritant in the presence of bright light.
Slovenian: PhotoBarr lahko draži oči in/ali kožo na močni svetlobi, ker lahko povzroči fotosenzitivnost.
English: Accidental exposure
Slovenian: Nenamerna izpostavljenost zdravilu
English: Feeling hot, injection site erythema, lethargy, malaise, oedema peripheral, pain, pitting oedema, temperature intolerance, weakness
Slovenian: Občutek vročine, rdečina na mestu injiciranja, letargija, slabost, periferni edem, bolečina, edem vdolbinice, neprenašanje toplote, oslabelost
English: Joint contracture, joint range of motion decreased, musculoskeletal chest pain,
Slovenian: Kontraktura sklepa, zmanjšani obseg gibljivosti sklepa, mišično-kostna bolečina v prsih, plantarni fascitis
English: The other ingredients are hydrochloric acid and/or sodium hydroxide (for pH adjustment).
Slovenian: - Ostale učinkovine so klorovodikova kislina in/ali natrijev hidroksid (za uravnavanje pHvrednosti).
English: Each vial contains 15 mg of porfimer sodium.
Slovenian: Ena viala vsebuje 15 mg porfimer-natrija.
English: affects 1 to 10 users in 100
Slovenian: prizadene 1 do 10od 100 bolnikov
English: Cardiac disorders Common:
Slovenian: Srčne bolezni Pogoste:
English: Pinnacle Biologics B.V., p/a Trust Company Amsterdam B.V., Crystal Tower 21st Floor, Orlyplein 10, 1043 DP Amsterdam, The Netherlands
Slovenian: Imetnik dovoljenja za promet z zdravilom Axcan Pharma International B.V., Engelenkampstraat 72, NL-6131JJ Sittard, Nizozemska
English: Each vial contains 75 mg of porfimer sodium.
Slovenian: Ena viala vsebuje 75 mg porfimer-natrija.
English: NAME OF THE MEDICINAL PRODUCT PhotoBarr 15 mg powder for solution for injection
Slovenian: IME ZDRAVILA PhotoBarr 15 mg prašek za raztopino za injiciranje
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
Slovenian: 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: Photosensitivity
Slovenian: Preobčutljivost
English: One or 2 laser light treatments were administered following PhotoBarr injection.
Slovenian: Po injiciranju PhotoBarra je sledilo eno do 2 zdravljenji z lasersko svetlobo.
English: Crystal Tower 21st Floor,
Slovenian: Engelenkampstraat 72
English: affects 1 to 10 users in 1,000
Slovenian: prizadene 1 do 10od 1.000 bolnikov
English: Prescriber guide and Prescriber slide kit − The educational tools are designed to aid physicians in optimising the benefit-risk
Slovenian: − Izobraževalna orodja so namenjena zdravnikom za optimiziranje razmerja koristi in
English: Oesophageal Stenosis
Slovenian: Stenoza požiralnika
English: NAME OF THE MEDICINAL PRODUCT PhotoBarr 75 mg powder for solution for injection.
Slovenian: IME ZDRAVILA PhotoBarr 75 mg prašek za raztopino za injiciranje.
English: HOW TO STORE PHOTOBARR
Slovenian: SHRANJEVANJE ZDRAVILA PHOTOBARR
English: Hydrochloric acid (for pH-adjustment)
Slovenian: Klorovodikova kislina (za uravnavanje pH-vrednosti) Natrijev hidroksid (za uravnavanje pH-vrednosti)
English: Hypersensitivity to the active substance, other porphyrins or to any of the excipients.
Slovenian: 4.3 Kontraindikacije - Preobčutljivost za zdravilno učinkovino, druge porfirine ali katero koli pomožno snov.
English: The other ingredients are hydrochloric acid and sodium hydroxide (for pH adjustment).
Slovenian: - Ostale učinkovine so klorovodikova kislina in natrijev hidroksid (za uravnavanje pH-vrednosti).
English: cover as much skin as possible by wearing a long-sleeved shirt, trousers, socks, shoes, gloves and a wide brimmed hat protect your eyes with dark sunglasses.
Slovenian: Če greste podnevi na prosto (tudi v oblačnem vremenu in med vožnjo z avtomobilom), se zaščitite, kot sledi: zakrijte si čim večji del kože tako, da nosite srajco z dolgimi rokavi, hlače, nogavice, čevlje, rokavice in širokokrajni klobuk, oči si zavarujte s temnimi sončnimi očali, ne pozabite vzeti k zdravniku zaščitnih oblačil in sončnih očal, ker boste po aplikaciji injekcije postali občutljivi na svetlobo.
English: − Caution should be exercised if patients have moderate hepatic disease
Slovenian: − Pri bolnikih z zmerno okvaro jeter je potrebna previdnost.
English: Instructions for reconstitution
Slovenian: Navodilo za pripravo zdravila
English: affects 1 to 10 users in 10,000
Slovenian: prizadene 1 do 10od 10.000 bolnikov