FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Če se ti znaki ne pojavijo, lahko postopno začnete opravljati običajne dejavnosti na prostem in zmanjšate izpostavljenost soncu v opoldanskih urah.
English: Photodynamic therapy with PhotoBarr should be applied by physicians trained in endoscopic use of PDT and only in those facilities properly equipped for the procedure.
Slovenian: Fotodinamično zdravljenje s PhotoBarrom naj uporabijo le zdravniki, ki so usposobljeni za endoskopsko uporabo PDT in le v tistih ustanovah, ki so primerno opremljene za ta postopek.
English: There may be an increase in the risk of thrombo-embolic events especially in patients with prolonged immobilization, post major surgery and other thromboembolic risk factors.
Slovenian: Pojavi se lahko povečano tveganje tromboembolije, še posebej pri bolnikih z dolgotrajno imobilizacijo, po večji operaciji in pri ostalih faktorjih tveganja za tromboembolijo.
English: Safety and efficacy in patients with treatment failure of other local mucosal ablative therapy has not been evaluated.
Slovenian: Varnosti in učinkovitosti pri bolnikih z neuspelim zdravljenjem z lokalno ablativno terapijo sluznice nismo ocenjevali.
English: Available treatment and surveillance guidelines should be considered.
Slovenian: Upoštevati je treba razpoložljivo zdravljenje in navodila za spremljanje bolnika.
English: Avoid direct exposure to bright indoor lights, including dental lamps, operating room lamps, unshaded light bulbs at close proximity or neon lights.
Slovenian: Izogibajte se neposredni izpostavljenosti močni notranji svetlobi vključno z zobozdravstvenimi svetilkami, lučmi v operacijskih dvoranah, nezasenčenimi žarnicami v neposredni bližini ali neonskimi lučmi.
English: Immune system disorders Not known:
Slovenian: Bolezni imunskega sistema Neznana:
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Slovenian: Načrt upravljanja tveganja (RMP, risk management plan) Imetnik dovoljenja za promet se zavezuje k izvajanju raziskav in drugih dejavnosti za spremljanje farmakovigilance, podrobno opredeljenih v načrtu farmakovigilance, kot narekuje različica RMP 2, predstavljena v modulu prijave v postopek za pridobivanje dovoljenja zdravila 1.8.2. in morebitnih dopolnilih RMP v skladu z navodili CHMP.
English: There is no information on overdose of PhotoBarr.
Slovenian: Ni podatkov o prevelikem odmerjanju PhotoBarra.
English: Photodynamic therapy with PhotoBarr has exclusively been studied in patients not suffering from severe medical conditions, such as congestive heart failure of advanced stage or serious pulmonary conditions that might impair the eligibility of patients for surgical procedures.
Slovenian: Fotodinamično zdravljenje s PhotoBarrom smo preučevali izključno pri bolnikih, ki ne trpijo zaradi hudih bolezenskih stanj, kot so kongestivna srčna odpoved v napredovali fazi ali hude pljučne bolezni, ki bi lahko vplivale na primernost bolnikov za kirurške posege.
English: The formation of oesophageal stenosis cannot be reduced or eliminated by the use of steroids.
Slovenian: Uporaba steroidov ne more zmanjšati ali preprečiti nastajanja stenoze.
English: Porfimer sodium is not dialyzable.
Slovenian: Porfimer-natrij ni primeren za dializo.
English: 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.
Slovenian: Bolniki lahko dobijo drugo epizodo PDT najmanj 90 dni po začetnem zdravljenju; predhodno zdravljeni del, ki še vedno kaže HGD, ali novi del lahko prejme do tri epizode PDT (vsako injekcijo posebej čez najmanj 90 dni), če je bila dolžina začetnega segmenta Barrettovega požiralnika >7 cm.
English: if you are not able to swallow at all or repeated vomiting occurs
Slovenian: - če sploh ne morete požirati ali če se bruhanje ponavlja.
English: Day 3a
Slovenian: 3. dan a
English: A second option (light intensity of 200 mW/cm) has also been included where necessary to accommodate lasers with a total capacity that does not exceed 2.5 W.
Slovenian: Po potrebi je dodana še druga možnost (jakost svetlobe 200 mW/cm) za prilagoditev laserjev s skupno zmogljivostjo, ki ne presega 2,5 W.
English: Based on evidence for a primarily hepatic/biliary elimination of photoactive substances, severity of phototoxic reactions and duration of the period of photosensitivity in patients with any grade of hepatic impairment may be increased.
Slovenian: Na osnovi dokazov za v prvi vrsti jetrno/žolčno izločanje fotoaktivnih spojin lahko zaključimo, da bosta resnost fototoksičnih reakcij in trajanje občutljivosti za svetlobo pri bolnikih s kakršno koli stopnjo okvare jeter lahko povečana.
English: 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.
Slovenian: Pri bolnikih so opravili kontrolne preglede vsake 3 mesece, dokler niso bili rezultati endoskopske biopsije 4 zaporednih četrtletnih kontrolnih pregledov negativni za HGD, nato pa dvakrat letno, dokler ni zadnji bolnik, vključen v raziskavo, zaključil najmanj 24-mesečnega obdobja kontrolnih ocen po naključni izbiri (randomizaciji).
English: Exposure of the skin to ambient indoor light is, however, beneficial because the remaining medicinal product will be inactivated gradually through a photobleaching reaction.
Slovenian: Izpostavljenost kože okoliški svetlobi na prostem je vsekakor koristna, ker se preostanek medicinskega izdelka postopno deaktivira s pomočjo fotobelilne reakcije.
English: Illumination of the target area with 630 nm wavelength laser light constitutes the second stage of therapy.
Slovenian: Osvetlitev ciljnega področja z lasersko svetlobo valovne dolžine 630 nm predstavlja drugo fazo zdravljenja.
English: Approximately 40-50 hours after PhotoBarr administration, light should be delivered by a fibre optic diffuser passed through the central channel of a centring balloon.
Slovenian: Približno 40-50 ur po dajanju PhotoBarra je potrebna osvetlitev z difuzorjem z optičnimi vlakni, ki poteka skozi osrednji kanal balona za centriranje.
English: Forty-one percent of patients showed normal squamous cell epithelium and 49% had absence of dysplasia.
Slovenian: Pri enainštiridesetih odstotkih bolnikov je bil opažen normalni ploščatocelični epitelij, pri 49% pa odsotnost displazije.
English: They consist mainly of sunburn-like reactions, mild redness on exposed skin, usually the face and hands.
Slovenian: Predstavljajo jih predvsem reakcije, podobne sončnim opeklinam, blaga rdečina na izpostavljeni koži, navadno na obrazu in rokah.
English: Metabolism and nutrition disorders Very common: Dehydration* Common:
Slovenian: Presnovne in prehranske motnje Zelo pogoste: Dehidracija* Pogoste:
English: Direct sunlight: Before you go to receive your PhotoBarr injection, check that there are adequate shades and curtains in your home to keep out bright sunlight.
Slovenian: Neposredna sončna svetloba: Preden greste po injekcijo PhotoBarra, se prepričajte, da so v vašem domu nameščeni ustrezni senčniki in zavese, ki vas ščitijo pred močno sončno svetlobo.
English: If you go on holiday to an area with more sunshine, remember to repeat the skin test, especially if some areas of skin have not been exposed to sunlight since your PhotoBarr treatment.
Slovenian: Če greste na dopust v kraje z več sončne svetlobe, ne pozabite ponoviti kožnega preskusa, še zlasti če nekateri predeli kože niso bili izpostavljeni sončni svetlobi od vašega zdravljenja s PhotoBarrom dalje.
English: It is possible that prolonged exposure to light at the clinical research unit or accidental sunlight exposure after discharge may be responsible for the high frequency of photosensitivity reactions.
Slovenian: Možno je, da daljša izpostavljenost svetlobi na oddelku za klinične raziskave ali naključna izpostavljenost sončni svetlobi po sprostitvi povzroči večjo pogostost fotosenzitivnih reakcij.
English: Conventional UV (ultraviolet) sunscreens are of no value in protecting against photosensitivity reactions because photoactivation is caused by visible light.
Slovenian: Običajni faktorji zaščite pred UV-žarki (ultravijoličnim sevanjem) so brez učinka pri zaščiti pred fotosenzitivnimi reakcijami, ker fotoaktivacijo povzroča vidna svetloba.
English: The majority of these reported adverse reactions were mild to moderate in intensity.
Slovenian: Večina teh opaženih neželenih učinkov je bila blagih do zmerno hudih.
English: Sufficient vials of PhotoBarr should be reconstituted to provide the patient with a dose of 2 mg/kg.
Slovenian: Pripraviti je treba zadostno število vial PhotoBarra, da se bolniku zagotovi odmerek 2 mg/kg.
English: Patients older than 75 years may be at a higher risk of respiratory related adverse events such as pleural effusion and dyspnoea.
Slovenian: Bolniki, starejši od 75 let, so morda bolj ogroženi, kar zadeva neželene učinke, povezane z dihanjem, kot so plevralni izliv in dispneja.
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.
Slovenian: Izogniti se je treba profilaktični uporabi kortikosteroidov, da bi zmanjšali nastanek strikture med zdravljenjem s PDT, ker se je izkazalo, da njegova uporaba ni zmanjšala in da lahko celo poslabša nastanek zoženja.
English: Acute hypersensitivity reactions including anaphylaxis have been reported.
Slovenian: Poročali so o akutnih preobčutljivostnih reakcijah, vključno z anafilaksijo.
English: An occurrence rate of 12% for oesophageal strictures was observed during the first course of treatment.
Slovenian: Opažena je bila 12% pogostost pojavljanja striktur požiralnika v prvi fazi zdravljenja.
English: WHAT PHOTOBARR IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO PHOTOBARR IN ZA KAJ GA UPORABLJAMO
English: If you go out during daylight hours (even on cloudy days and while travelling in a vehicle), you should take the following precautions: 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.
English: Required Power Output from Diffuser a
Slovenian: Zahtevana izhodna moč iz difuzorja a
English: Efficacy and especially safety of PDT with PhotoBarr have not been established in patients with contraindications to, or not being eligible for, oesophagectomy.
Slovenian: Učinkovitost in predvsem varnost PDT s PhotoBarrom ni bila ugotovljena pri bolnikih s kontraindikacijami ali pri tistih, ki niso primerni za ezofagektomijo.
English: If you miss the laser light treatment
Slovenian: Če ste izpustili zdravljenje z lasersko svetlobo
English: Medicinal products that decrease clotting, vasoconstriction or platelet aggregation, e.g., thromboxane A2 inhibitors, could decrease the efficacy of PDT.
Slovenian: Medicinski izdelki, ki zmanjšujejo strjevanje krvi, vazokonstrikcijo ali agregacijo trombocitov, npr. inhibitorji tromboksana A2, bi lahko zmanjšali učinkovitost PDT.
English: − Healthcare professionals should be aware of side effects that may arise during or shortly after treatment, and how to treat them.
Slovenian: − Zdravstveno osebje se mora zavedati možnih neželenih učinkov, ki se lahko pojavijo med ali kmalu po zdravljenju, ter kako ukrepati, če se neželeni učinki pojavijo.
English: Elderly patients(≥ 65 years old) Dose modification based upon age is not required.
Slovenian: Starejši bolniki (> 65 let starosti) Odmerka ni treba prilagoditi starosti bolnika.
English: With light activation, porfimer sodium was mutagenic in some in-vitro tests.
Slovenian: Pri aktiviranju svetlobe je bil porfimer-natrij mutagen v nekaterih in vitro preskusih.
English: What PhotoBarr is and what it is used for 2.
Slovenian: Kaj je zdravilo PhotoBarr in za kaj ga uporabljamo 2.
English: The MAH shall agree the details of educational materials with the National Competent Authorities to ensure that all health care professionals who intend to prescribe and/or dispense PhotoBarr are provided with the following:
Slovenian: Imetnik dovoljenja za promet z zdravilom se mora o podrobnostih glede izobraževalnega gradiva dogovoriti s pristojnim nacionalnim organom in zagotoviti, da vsi zdravniki, ki bodo zdravilo lahko predpisovali, in drugo zdravstveno osebje oz. farmacevti, ki bodo delali z zdravilom, prejmejo naslednja gradiva:
English: It is not known whether porfimer sodium is excreted into human breast milk.
Slovenian: Ni znano, ali se porfimer-natrij izloča v materino mleko.
English: Photodynamic therapy with PhotoBarr is a 2-stage process.
Slovenian: Fotodinamično zdravljenje s PhotoBarrom je 2-stopenjski proces.
English: The most frequently reported treatment-associated serious adverse reaction (SAR) was dehydration (4%), experienced by 5 patients.
Slovenian: Huda neželena reakcija (HNR), o kateri so najpogosteje poročali kot o posledici zdravljenja, je bila dehidracija (4%), ki je bila prisotna pri 5 bolnikih.
English: Procedure
Slovenian: Postopek
English: A small area of skin should be exposed to sunlight for 10 minutes.
Slovenian: Majhen predel kože je treba izpostaviti sončni svetlobi za 10 minut.
English: 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. 39% and 11% respectively)
Slovenian: Pri bolnikih, ki so prejeli samo eno epizodo PDT, je bilo tveganje razvoja raka večje kot pri bolnikih, ki so prejeli 2 ali 3 epizode PDT (50% proti 39 oz. 11%).
English: Pharmacotherapeutic group: Sensitizers used in photodynamic/radiation therapy, ATC code: L01XD01
Slovenian: Farmakoterapevtska skupina: Senzibilizatorji, ki se uporabljajo za fotodinamično/obsevalno zdravljenje, oznaka ATC: L01XD01
English: To calculate the light dose, the following specific light dosimetry equation applies for all fibre optic diffusers:
Slovenian: Da bi izračunali odmerek svetlobe, se za vse difuzorje z optičnimi vlakni uporablja naslednja posebna enačba za odmerjanje svetlobe:
English: − Patients should be warned of the possibility of long term side effects, especially photosensitivity, and the need to seek medical assistance if they arise.
Slovenian: − Bolnike je treba opozoriti na možnost dolgotrajnih neželenih učinkov, posebno preobčutljivosti na svetlobo, in poučiti, da v takih primerih poiščejo zdravstveno pomoč.
English: 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.
Slovenian: Očistek v različnih tkivih se pojavi po 40-72 urah, vendar pa porfimer-natrij dalj časa ostane v tumorjih, koži in organih retikuloendotelijskega sistema (vključno z jetri in vranico).
English: High-grade dysplasia in Barrett's oesophagus of < 7 cm
Slovenian: Displazija visoke stopnje v Barrettovem požiralniku < 7 cm
English: Patients should be advised to consult their ophthalmologist if they notice any vision changes after treatment with PhotoBarr PDT.
Slovenian: Bolnikom je treba svetovati, da se posvetujejo z oftalmologom, če opazijo kakršne koli spremembe vida po zdravljenju s PhotoBarrom PDT.
English: 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.
Slovenian: Primerjava med krivuljama preživetja pri dveh zdravljenih skupinah z uporabo testa log rank je pokazala statistično pomembno razliko med krivuljama v obeh skupinah populacije ITT (p=0,0014), kar kaže na pomemben zastoj v napredovanju raka.
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 5.1).
Slovenian: V kliničnih raziskavah s PhotoBarrom je bil opravljen spremljevalni kontrolni pregled vsake tri mesece ali celo vsakih šest mesecev po tem, ko rezultati štirih zaporednih biopsij niso več pokazali visoke stopnje displazije (glejte poglavje 5.1).
English: PhotoBarr PDT regularly causes dysphagia, odynophagia, nausea and vomiting.
Slovenian: PhotoBarr PDT redno povzroča disfagijo, odinofagijo, slabost in bruhanje.
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.
Slovenian: V primeru trdovratne HGD je možno nadaljnje zdravljenje (do največ treh ciklusov) (v razmaku najmanj 90 dni), da se poveča odstotek odzivov.
English: Women of child-bearing potential should use effective contraception before, during and for at least 90 days after treatment.
Slovenian: Ženske v rodni dobi naj uporabljajo učinkovito kontracepcijo pred zdravljenjem, med njim in najmanj 90 dni po zaključku zdravljenja.
English: Table 2 provides the settings that would be used to deliver the dose within the shortest time (light intensity of 270 mW/cm).
Slovenian: V preglednici 2 se nahajajo nastavitve, ki se morajo uporabljati za dajanje odmerka v najkrajšem času (jakost svetlobe 270 mW/cm).
English: Short (< 2.5 cm) fibre optic diffuser (50 J/cm)
Slovenian: Difuzor s kratkimi (< 2,5 cm) optičnimi vlakni (50 J/cm)
English: Photoactivation
Slovenian: Fotoaktivacija
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.
Slovenian: O drugih manj pogostih kožnih pojavih so poročali na področjih, kjer so se pojavile preobčutljivostne reakcije, kot so večja poraščenost, obarvanje kože, vozlički v koži, nagubanje kože in krhkost kože.
English: Intravenous use
Slovenian: Za intravensko uporabo
English: PhotoBarr should be administered as a single slow intravenous injection over 3 to 5 minutes.
Slovenian: PhotoBarr je treba dajati kot enkratno počasno intravensko injekcijo 3 do 5 minut.
English: − It is important to follow exactly the correct steps for reconstitution and administration of porfimer.
Slovenian: − Pomembno je natančno slediti korakom za pripravo in odmerjanje.
English: Before exposing any area of skin to direct sunlight or bright indoor light, the patient should test it for residual photosensitivity.
Slovenian: Pred izpostavitvijo katerega koli dela kože neposredni sončni svetlobi ali močni svetlobi v prostoru, mora bolnik preizkusiti rezidualno občutljivost na svetlobo.
English: If accidentally injected paravenously there may be damage to paravenous tissue.
Slovenian: Če se pomotoma vbrizga v okolico vene, lahko poškoduje okoliško tkivo.
English: Women of childbearing age should take adequate contraceptive precautions whilst and up to 90 days after receiving PhotoBarr.
Slovenian: Ženske v rodni dobi naj jemljejo ustrezna kontracepcijska sredstva med in do 90 dni po uporabi PhotoBarra.
English: Co-administration of omeprazole (20 mg BID) began at least 2 days before PhotoBarr injection.
Slovenian: Sočasna uporaba omeprazola (20 mg dvakrat na dan) se je začela najmanj 2 dni pred injiciranjem PhotoBarra.
English: 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.
Slovenian: Pazite, da izdelek ne pride v stik s kožo in očmi, ker lahko pri izpostavljenosti svetlobi izzove preobčutljivostne reakcije; priporočljiva je uporaba gumijastih rokavic in zaščite za oči.
English: Radical initiation may occur after porfimer sodium absorbs light to form a porphyrin excited state.
Slovenian: Nastajanje radikalov se lahko pojavi po tem, ko porfimer-natrij absorbira svetlobo, da nastane povečano stanje porfirina.
English: Method of administration For instructions on reconstitution prior to administration, see section 6.6
Slovenian: Postopek uporabe Pred uporabo preberite navodila za pripravo, glejte poglavje 6.6
English: The recommended dose of PhotoBarr is 2 mg/kg body weight.
Slovenian: Odmerjanje Priporočeni odmerek PhotoBarra je 2 mg/kg telesne mase.
English: You may need to read it again If you have any further questions, please ask your doctor or pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
English: Check for the appearance of red marks, swelling or blistering after one day.
Slovenian: Po enem dnevu preverite, ali so se pojavila rdeča znamenja, oteklina ali mehurčki.
English: − You should not be treated with PhotoBarr if you have severe liver disease (eg
Slovenian: − Zdravljenja s PhotoBarrom ne smete prejemati, če imate hudo okvaro jeter (npr.
English: - Suspected erosion of major blood vessels due to risk of massive, potentially fatal haemorrhage.
Slovenian: - Sum za razjedo velikih krvnih žil zaradi nevarnosti masivne, potencialno usodne krvavitve.
English: The first stage of PDT is the slow intravenous injection of PhotoBarr.
Slovenian: Prva stopnja PDT je počasno intravensko injiciranje PhotoBarra.
English: Note: No more than 1.5 times the required diffuser power output should be needed from the laser.
Slovenian: Opomba: Potrebna je največ 1,5-kratna zahtevana izhodna moč razpršitve svetlobe iz laserja.
English: Manufacturer Axcan Pharma SAS, Route de Bû, 78550 Houdan, France
Slovenian: Izdelovalec Axcan Pharma SAS, Route de Bû, 78550 Houdan, Francija
English: The mean elimination half-life (t1/2) was 21.5 days (CV 26 %, range 264-672) in patients and 17 days in volunteers.
Slovenian: Srednja razpolovni čas izločanja (t1/2) je bila pri bolnikih 21,5 dni (CV 26%, razpon 264-672) in pri prostovoljcih 17 dni.
English: Very rare:
Slovenian: Zelo redko:
English: − It is important to have an appropriate light dose and a proper setting for the laser.
Slovenian: − Pomembno je, da je osvetlitev ustrezno odmerjena in da so nastavitve laserja pravilne.
English: Indoor light:
Slovenian: Notranja svetloba:
English: Laser treatment should not be given if an overdose of PhotoBarr is administered.
Slovenian: Lasersko zdravljenje se ne sme uporabiti, če je bil dan prevelik odmerek PhotoBarra.
English: Preclinical data also suggest that tissue ischaemia, allopurinol, calcium channel blockers and some prostaglandin synthesis inhibitors could interfere with PhotoBarr PDT.
Slovenian: Predklinični podatki prav tako kažejo na ishemijo tkiva, alopurinol, blokatorji kalcijevih kanalčkov in nekateri zaviralci sinteze prostaglandina pa bi lahko vplivali na zdravljenje s PhotoBarrom PDT.
English: Expose a small area of skin to sunlight for 10 minutes.
Slovenian: Majhno površino kože izpostavite sončni svetlobi za 10 minut.
English: Light doses of two to three times the recommended dose have been administered to a few patients with superficial endobronchial tumours.
Slovenian: Odmerki (laserske) svetlobe, ki so enaki dvakratnim ali trikratnim priporočenim odmerkom, so bili uporabljeni pri maloštevilnih bolnikih s površinskimi endobronhialnimi tumorji.
English: For most patients (up to 75 kg) two vials of PhotoBarr 75 mg will suffice.
Slovenian: Pri večini bolnikov (do 75 kg) zadostujeta dve viali PhotoBarra 75 mg. 15 mg-viala PhotoBarra se doda na vsakih dodatnih 7,5 kg telesne mase.
English: Fibre optic diffuser/balloon combinationa
Slovenian: Kombinacija difuzorja z optičnimi vlakni/balonaa