natgillin/translations-raw huggingface dataset:
Če naj se PDT uporablja pred ali po radioterapiji, je potrebno dovolj časa med zdravljenji, da se zagotovi, da se je vnetna reakcija, ki jo je povzročilo prvo zdravljenje, umirila pred začetkom drugega
If PDT is to be used before or after radiotherapy, sufficient time should be allowed between the therapies to ensure that the inflammatory reaction produced by the first treatment has subsided prior to commencement of the second treatment.
V primeru predhodno zdravljenega segmenta požiralnika, kadar ni bil dovolj ozdravljen, in/ali če histološka ocena opravljenih biopsij ni jasna, se lahko naslednja epizoda PDT prestavi še za 1-2 meseca.
In the case of a previously treated oesophageal segment, if it has not sufficiently healed and/or histological assessment of biopsies is not clear, the subsequent course of PDT may be delayed for an additional 1-2 months.
EU/1/04/272/001
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o Bolniki morajo biti seznanjeni z možnimi nevarnostmi (fototip kože in okvare jeter).
o Patients should be aware of potential risk factors (skin phototype and hepatic impairment).
Kot vsa zdravila, ima lahko tudi zdravilo PhotoBarr neželene učinke, ki pa se ne pojavijo pri vseh
Like all medicines, PhotoBarr can cause side effects, although not everybody gets them.
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Pogoji shranjevanja pripravljenega zdravila so navedeni v razdelku 6.3.
For storage conditions of the reconstituted medicinal product, see section 6.3.
Raziskave toksičnosti na reprodukcijo so bile nezadostne, da bi podpirale varnost porfimer-natrija med nosečnostjo, ker ni bila uporabljena aktivacija svetlobe.
Reproductive toxicology studies were insufficient to support the safety of porfimer sodium during pregnancy, as no light activation had been used.
Ni znano:
Not known:
Ne mešajte PhotoBarra z drugimi medicinskimi izdelki v isti
Do not mix PhotoBarr with other medicinal products in the same solution.
Neželeni učinki, o katerih so poročali, so našteti spodaj v Preglednici 5 glede na vrsto organskega sistema in njihovo pogostost.
Adverse reactions reported are listed below in Table 5 by organ class and frequency.
V teh raziskavah je nastala toksičnost za zarodek, ne pa tudi teratogenost, pri podganah in kuncih le pri ocenjenih intravenskih odmerkih (večjih ali enakih 4 mg/kg) in pri klinični uporabi pri večji primerjani pogostosti (dnevno).
In these studies foetotoxicity, but not teratogenicity, occurred in rats and rabbits only at evaluated intravenous doses (greater than of equal to 4 mg/kg) and at greater frequency (daily) compared in the clinical use.
Občutljivost na svetlobo je posledica preostalih fotoaktivnih snovi, ki bodo prisotne na vseh delih kože.
The photosensitivity is due to residual photoactive substances, which will be present in all parts of the skin.
Kadar je možno, naj izbrani segment za prvo uporabo svetlobe zajema vsa področja HGD.
Whenever possible, the segment selected for the first light application should include all the areas of HGD.
Zato v tem času bolniki ne smejo ostati v zatemnjenem prostoru, treba pa jih je tudi spodbujati, da izpostavljajo kožo okoliški svetlobi v prostoru.
Therefore, patients should not stay in a darkened room during this period and should be encouraged to expose their skin to ambient indoor light.
PhotoBarr ni niti primarni okularni iritant niti primarni dermalni iritant.
PhotoBarr is neither a primary ocular irritant nor a primary dermal irritant.
Fotosenzitivne reakcije so zelo pogost neželeni učinek PhotoBarra (prizadenejo več kot 2 bolnika od 3).
Photosensitivity reactions are very common side effects of PhotoBarr (affecting more than 2 users in 3).
so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Zato je treba paziti, da se prepreči izliv (ekstravazacija) na mestu injiciranja.
Therefore, care should be taken to prevent extravasation at the injection site.
− V roku 60 dni od doseganja pomembnega mejnika (na področju farmakovigilance ali
− Within 60 days of an important (pharmacovigilance or risk minimisation) milestone
Ni znane koristi od vbrizgavanja druge snovi na mesto ekstravazacije.
There is no known benefit from injecting the extravasation site with another substance.
Majhen predel kože je treba izpostaviti sončni svetlobi za 10 minut.
A small area of skin should be exposed to sunlight for 10 minutes.
Okvara celic, ki jo povzroči porfimer-natrij PDT, je posledica širjenja reakcij prostih radikalov.
Cellular damage caused by porfimer sodium PDT is a consequence of the propagation of free radical reactions.
Porfimer-natrij je mešanica enot porfirina, ki se med seboj vežejo v verigah po dve do osem enot.
Porfimer sodium is a mixture of porphyrin units, which are linked together in chains of two to eight units.
Če ni fotosenzitivne reakcije v 24 urah (rdečina, edem, mehurčki), lahko bolnik postopoma spet začne opravljati običajna opravila na prostem, pri čemer naj bo v začetku previden, postopoma pa si lahko dovoli čedalje večjo izpostavljenost.
If no photosensitivity reaction (erythema, oedema, blistering) occurs within 24 hours, the patient can gradually resume normal outdoor activities, initially continuing to exercise caution and gradually allowing increased exposure.
Obiščite specialista za očesne bolezni.
You should visit your eye specialist.
- Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Posledica zdravljenja s PDT je, da se lahko bolniki pritožujejo nad bolečino v prsih pod grodnico zaradi vnetnih reakcij v področju zdravljenja.
As a result of PDT treatment, patients may complain of substernal chest pain because of inflammatory responses within the area of treatment.
Farmakokinetiko porfimer-natrija so preučevali pri 12 bolnikih z endobronhialnim rakom in 23 zdravih osebah (11 moških in 12 ženskah), ki so prejeli 2 mg/kg porfimer-natrija s počasnim intravenskim injiciranjem.
The pharmacokinetics of porfimer sodium have been studied in 12 patients with endobronchial cancer and 23 healthy subjects (11 men and 12 women), given 2 mg/kg porfimer sodium through slow intravenous injection.
V času zdravljenja s svetlobo lahko dobite sedative.
During your light treatment you may receive sedation.
Da bi povečali vašo stopnjo odzivnosti, boste morda potrebovali do tri cikluse PDT v razmaku najmanj 90
To increase your response rate, you may need up to three PDT courses, separated by at least 90 days.
Kot v primeru terapevtskega prekomernega odmerka, je treba osebo, ki je bila izdelku izpostavljena nenamerno, zaščititi pred močno svetlobo.
As with therapeutic overdose, any accidentally overexposed person must be protected from bright light.'
V tem primeru se morate izogibati vsem aktivnostim, ki zahtevajo vašo pozornost, kot je na primer vožnja ali upravljanje
In this case, you should avoid any activities that require mental alertness such as driving a car or using any machine.
Na podlagi predkliničnih raziskav se sprejemljiva jakost svetlobe za kombinacijo balona/difuzorja uvršča med 175 in 270 mW/cm difuzorja.
Based on preclinical studies, acceptable light intensity for the balloon/diffuser combination ranges from 175-270 mW/cm of diffuser.
Z ZDRAVILOM Pinnacle Biologics B.V. p/a Trust Company Amsterdam B.V.
Pinnacle Biologics B.V. p/a Trust Company Amsterdam B.V.
Pojavi se lahko povečano tveganje tromboembolije, še posebej pri bolnikih z dolgotrajno imobilizacijo, po večji operaciji in pri ostalih faktorjih tveganja za tromboembolijo.
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.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
You may need to read it again If you have any further questions, please ask your doctor or pharmacist.
tega je treba posodobljen RPM oddati v naslednjih primerih:
In addition, an updated RMP should be submitted:
Preobčutljivostne reakcije na svetlobo so se pojavile najprej na obrazu, rokah in v predelu vratu, tj. na področjih kože, ki so najbolj občutljiva za naključno izpostavljenost sončni svetlobi.
The photosensitivity reactions occurred primarily on the face, hands, and neck regions, which are the areas of the skin that are most susceptible to accidental sunlight exposure.
Ni podatkov o prevelikem odmerjanju PhotoBarra.
There is no information on overdose of PhotoBarr.
Raziskava, ki je preučevala farmakodinamične interakcije, je pokazala, da lahko uporaba kortikosteroidov, ki se dajejo pred PDT ali sočasno z njim, da bi zmanjšali nastanek zoženja, zmanjša
A study investigating pharmacodynamic interactions has demonstrated that corticosteroids given before or concomitant with PDT to decrease formation of strictures may decrease the safety of treatment.
Večina teh pojavov je bila blage do zmerne stopnje in jih je bilo mogoče odpraviti v 1-2 razširitvah (dilatacijah).
The majority of these was mild to moderate in intensity and could be managed through 1-2 dilatations.
Na razpolago ni nobenih farmakokinetičnih podatkov in podatkov o varnosti za bolnike z okvaro jeter.
No pharmacokinetic and safety data in patients with hepatic impairment are available.
Uporabe zdravila PhotoBarr pri otrocih, mlajših od 18 let, ni mogoče priporočiti zaradi nezadostnih podatkov o varnosti in učinkovitosti v tej starostni skupini.
PhotoBarr is not recommended for use in children below age 18 years due to a lack of data on safety and efficacy.
Osvetlitev ciljnega področja z lasersko svetlobo valovne dolžine 630 nm predstavlja drugo fazo zdravljenja.
Illumination of the target area with 630 nm wavelength laser light constitutes the second stage of therapy.
Porfimer-natrij ni bil mutagen v običajnih raziskavah genotoksičnosti v odsotnosti svetlobe.
Porfimer sodium was not mutagenic in standard genotoxicity tests in the absence of light.
IME IN NASLOV IMETNIKA DOVOLJENJA
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Približno 40-50 ur po dajanju PhotoBarra je potrebna osvetlitev z difuzorjem z optičnimi vlakni, ki poteka skozi osrednji kanal balona za centriranje.
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.
Pripraviti je treba zadostno število vial PhotoBarra, da se bolniku zagotovi odmerek 2 mg/kg.
Sufficient vials of PhotoBarr should be reconstituted to provide the patient with a dose of 2 mg/kg.
Če bolniki potujejo v drugo geografsko območje, kjer je veliko sončne svetlobe, morajo ponovno preskusiti svojo stopnjo občutljivosti na svetlobo.
If patients travel to a different geographical area with greater sunshine, they should retest their level of photosensitivity.
Zahtevana izhodna moč iz difuzorja a
Required power output from diffuser a
Aktivnejši način življenja zdravih in sorazmerno mladih bolnikov v primerjavi z rakavimi bolniki je morda dejavnik, ki prispeva k omenjenim
The more active lifestyle of the healthy and relatively younger subjects compared with cancer patients may have been a contributing factor to these photosensitivity reactions.
Upoštevati je treba razpoložljivo zdravljenje in navodila za spremljanje bolnika.
Available treatment and surveillance guidelines should be considered.
Opažena je bila 12% pogostost pojavljanja striktur požiralnika v prvi fazi zdravljenja.
An occurrence rate of 12% for oesophageal strictures was observed during the first course of treatment.
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.
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.
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU Izdaja zdravila je le pod omejenimi pogoji
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
− Zdravstveno osebje se mora zavedati možnih neželenih učinkov, ki se lahko pojavijo med ali kmalu po zdravljenju, ter kako ukrepati, če se neželeni učinki
− Healthcare professionals should be aware of side effects that may arise during or shortly after treatment, and how to treat them.
prizadene 1 do 10od 10.000 bolnikov
affects 1 to 10 users in 10,000
Prva stopnja PDT je počasno intravensko injiciranje PhotoBarra.
The first stage of PDT is the slow intravenous injection of PhotoBarr.
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.
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.
Varnosti in učinkovitosti pri bolnikih z neuspelim zdravljenjem z lokalno ablativno terapijo sluznice nismo ocenjevali.
Safety and efficacy in patients with treatment failure of other local mucosal ablative therapy has not been evaluated.
Uporaba steroidov ne more zmanjšati ali preprečiti nastajanja stenoze.
The formation of oesophageal stenosis cannot be reduced or eliminated by the use of steroids.
Porfimer-natrij ni primeren za dializo.
Porfimer sodium is not dialyzable.
ima za posledico fotokemični, ne pa tudi toplotnega učinka.
The laser treatment induces a photochemical, not a thermal, effect.
Bolniki, starejši od 75 let, so morda bolj ogroženi, kar zadeva neželene učinke, povezane z dihanjem, kot so plevralni izliv in dispneja.
Patients older than 75 years may be at a higher risk of respiratory related adverse events such as pleural effusion and dyspnoea.
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
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.
Poleg tega se morajo lečeči zdravniki zavedati možnosti bujnega razraščanja ploščatega epitelija in nevarnosti, da spregledajo raka.
Also, treating physicians should be aware of the possibility of squamous overgrowth and the risk of overlooking cancer.
Krvne vzorce so dobili do 56 dni (bolniki) ali 36 dni (prostovoljci) po
Plasma samples were obtained out to 56 days (patients) or 36 days (volunteers) post-injection.
Fotoaktivacija
Photoactivation
Možno je, da daljša izpostavljenost svetlobi na oddelku za klinične raziskave ali naključna izpostavljenost sončni svetlobi po sprostitvi povzroči večjo pogostost fotosenzitivnih reakcij.
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.
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).
All patients who receive PhotoBarr will be photosensitive and must observe precautions to avoid sunlight and bright indoor light (see section 4.4).
ne pozabite vzeti k zdravniku zaščitnih oblačil in sončnih očal, ker boste po aplikaciji injekcije
remember to take protective clothing and sunglasses with you to your appointment, as you will be photosensitive once the injection has been given.
Podatki o dolgotrajnem učinku PhotoBarra (več kot dve leti)
Data on the long-term effect of PhotoBarr (beyond two years) are not available at the moment.
Poročali so o akutnih preobčutljivostnih reakcijah, vključno z anafilaksijo.
Acute hypersensitivity reactions including anaphylaxis have been reported.
Zdravilo dajemo le takrat, ko je na voljo material in osebje, izkušeno v ocenjevanju in zdravljenju anafilaksije.
The medicinal product should only be administered when material and personnel experienced in evaluating and treating anaphylaxis are immediately available.
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).
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.
Ni znano, ali se porfimer-natrij izloča v materino mleko.
It is not known whether porfimer sodium is excreted into human breast milk.
Opomba: Potrebna je največ 1,5-kratna zahtevana izhodna moč razpršitve svetlobe iz laserja.
Note: No more than 1.5 times the required diffuser power output should be needed from the laser.
PhotoBarr je treba dajati kot enkratno počasno intravensko injekcijo 3 do 5 minut.
PhotoBarr should be administered as a single slow intravenous injection over 3 to 5 minutes.
Huda neželena reakcija (HNR), o kateri so najpogosteje poročali kot o posledici zdravljenja, je bila dehidracija (4%), ki je bila prisotna pri 5 bolnikih.
The most frequently reported treatment-associated serious adverse reaction (SAR) was dehydration (4%), experienced by 5 patients.
− Pomembno je, da je osvetlitev ustrezno odmerjena in da so nastavitve laserja pravilne.
− It is important to have an appropriate light dose and a proper setting for the laser.
smejo upravljati vozil ali strojev po zdravljenju s svetlobo, če so bili pri postopku sedirani.
Patients should not drive or use machines after the light treatment if they have been sedated for the procedure.
Zelo redko:
Very rare:
PhotoBarr PDT redno povzroča disfagijo, odinofagijo, slabost in bruhanje.
PhotoBarr PDT regularly causes dysphagia, odynophagia, nausea and vomiting.
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).
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).
prizadene manj kot 1 od 10.000 bolnikov
affects less than 1 user in 10,000
Postopek uporabe Pred uporabo preberite navodila za pripravo, glejte poglavje 6.6
Method of administration For instructions on reconstitution prior to administration, see section 6.6
Pred izpostavitvijo katerega koli dela kože neposredni sončni svetlobi ali močni svetlobi v prostoru, mora bolnik preizkusiti rezidualno občutljivost na svetlobo.
Before exposing any area of skin to direct sunlight or bright indoor light, the patient should test it for residual photosensitivity.
s kratkimi (< 2,5 cm) optičnimi vlakni (50 J/cm)
Short (< 2.5 cm) fibre optic diffuser (50 J/cm)
- Sum za razjedo velikih krvnih žil zaradi nevarnosti masivne, potencialno usodne krvavitve.
- Suspected erosion of major blood vessels due to risk of massive, potentially fatal haemorrhage.
Nastajanje radikalov se lahko pojavi po tem, ko porfimer-natrij absorbira svetlobo, da nastane povečano stanje porfirina.
Radical initiation may occur after porfimer sodium absorbs light to form a porphyrin excited state.
Po enem dnevu preverite, ali so se pojavila rdeča znamenja, oteklina ali mehurčki.
Check for the appearance of red marks, swelling or blistering after one day.
− Zdravljenja s PhotoBarrom ne smete prejemati, če imate hudo okvaro jeter (npr.
− You should not be treated with PhotoBarr if you have severe liver disease (eg
Preglednica 3.
Table 3.
Če se pomotoma vbrizga v okolico vene, lahko poškoduje okoliško tkivo.
If accidentally injected paravenously there may be damage to paravenous tissue.
o Vsi bolniki se morajo poučiti o tem, da UV-zaščita nima zaščitnega delovanja pri vidni svetlobi, s kakršno se porfirini aktivirajo.
o all patients should know that UV blocking is not effective in blocking visible light which activates porfimer.
Izbira kombinacije difuzorja z optičnimi vlakni/balona je odvisna od dolžine požiralnika, ki jo je treba zdraviti (Preglednica 1).
The choice of fibre optic/balloon diffuser combination will depend on the length of oesophagus to be treated (Table 1).
PhotoBarra ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatlici in viali za oznako EXP.
Do not use PhotoBarr after the expiry date which is stated on the carton and vial after EXP.
V primeru dajanja prevelikih odmerkov, si morajo bolniki za 90 dni zaščititi oči in kožo pred neposredno sončno svetlobo ali močno zunanjo svetlobo.
In the event of an overdose, patients should protect their eyes and skin from direct sunlight or bright indoor lights for 90 days.
s PhotoBarrom naj uporabijo le zdravniki, ki so usposobljeni za endoskopsko uporabo PDT in le v tistih ustanovah, ki so
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.
PhotoBarr je zdravilo, ki ga aktivira svetloba, in se uporablja za fotodinamično zdravljenje (PDT) (photodynamic therapy) v kombinaciji z rdečo nevročo lasersko svetlobo.
PhotoBarr is a light-activated medicine used photodynamic therapy (PDT)in combination with a non-burning, red laser light.
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.
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.
Pljučnica
Pneumonia
Rekonstituirana raztopina PhotoBarra (ml) = bolnikova masa (kg) x 2 mg/kg = 0,8 x bolnikova masa
Reconstituted PhotoBarr solution (ml) = Patient's weight (kg) x 2 mg/kg = 0.8 x patient's weight
Injiciranje zdravila PhotoBarr: Prejeli boste eno intravensko injekcijo PhotoBarra (2 mg na kg telesne mase) 40 do 50 ur pred zdravljenjem z lasersko svetlobo.
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.
Prehrana pri bolnikih
Nutrition in Patients
Razlit PhotoBarr obrišite z vlažno krpo.
Spills of PhotoBarr should be wiped up with a damp cloth.
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.
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.
V tem času je treba na bolnikih opraviti preskus glede rezidualne občutljivosti na svetlobo (glejte poglavje 4.4).
At this time, patients should test for residual photosensitivity (see section 4.4).