natgillin/translations-raw huggingface dataset:
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Tega zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjeni v poglavju 6.6. 6.3 Rok uporabnosti
As per the CHMP Guideline on Risk Management Systems for medicinal products of human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
V skladu s smernicami Odbora za zdravila za humano medicino (CHMP) glede sistema upravljanja tveganja za uporabo zdravil za humano medicino, je potrebno posodobljen RPM priložiti sočasno z naslednjim rednim poročilom o varnosti zdravila (PSUR, periodic safety update report).
The serum decay was bi-exponential, with a slow distribution phase and a very long elimination phase that started approximately 24 hours after injection.
Razgradnja v serumu je bila bieksponenčna, s počasno fazo porazdelitve ter zelo dolgo fazo izločanja, ki se je začela približno 24 ur po injiciranju.
At the time of intended photoactivation 40-50 hours after injection, the pharmacokinetic profiles of porfimer sodium in men and women were very similar.
V času načrtovane fotoaktivacije 40-50 ur po injiciranju so bili farmakokinetični profili porfimer-natrija pri moških in ženskah zelo podobni.
Animal studies are insufficient with respect to effects on pregnancy, embryo/foetal development, parturition and postnatal development (see section 5.3).
Študije na živalih ne zadoščajo, kar zadeva vplive na nosečnost, razvoj zarodka/plodu, porod in razvoj otroka po rojstvu (glejte poglavje 5.3).
The laser treatment induces a photochemical, not a thermal, effect.
Lasersko zdravljenje ima za posledico fotokemični, ne pa tudi toplotnega učinka.
Only a solution without particles should be used and without visible signs of deterioration.
Uporabiti je dovoljeno le raztopino brez delcev in brez vidnih znakov kvarjenja.
Some other medicines may increase the risk for photosensitivity reactions for example antibiotics or antidiabetic medicines.
Nekatera zdravila lahko povečajo tveganje za preobčutljivostne reakcije na svetlobo, na primer antibiotiki ali antidiabetična zdravila.
Subsequent free radical reactions can form superoxide and hydroxyl radicals.
Zaradi poznejših reakcij prostih radikalov lahko nastanejo superoksid in radikali hidroksila.
All incidences of strictures were considered associated with treatment of which 1% was considered serious.
Vsi primeri striktur bi naj bili povezani z zdravljenjem, od tega je 1% veljal za hude.
However, to speed up the natural process of inactivating the medicine in your body, it is good to expose the skin to normal levels of indoor light.
Da bi pospešili naravni proces deaktiviranja zdravila v telesu, je dobro izpostaviti kožo običajni jakosti notranje svetlobe.
Spills and disposal
Razlitje in odstranjevanje
How does photodynamic therapy (PDT) work?
Kako poteka fotodinamično zdravljenje (PDT)?
Progression to cancer was related to the number of PDT courses administered.
Razvoj raka je bil povezan s številom opravljenih ciklusov PDT.
If extravasation does occur, the area should be protected from light for a minimum of 90 days.
Če pride do izliva, je treba to področje zaščititi pred svetlobo najmanj 90 dni.
The level of photosensitivity will vary for different areas of the body, depending on the extent of previous exposure to light.
Stopnja občutljivosti na svetlobo se spreminja glede na različne dele telesa, odvisno od stopnje predhodne izpostavljenosti svetlobi.
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.
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 zdravljenja.
If you realise that you have missed your appointment for the laser treatment, contact your doctor immediately.
Če ugotovite, da ste zamudili obisk za zdravljenje z lasersko svetlobo, se takoj posvetujte z zdravnikom.
Do not mix PhotoBarr with other medicinal products in the same solution.
Ne mešajte PhotoBarra z drugimi medicinskimi izdelki v isti raztopini.
if any of these signs are seen, then continue to protect yourself from bright light for 2 more weeks, then repeat the skin test.
Če opazite katere od teh znakov, se še naprej zaščitite pred močno svetlobo v naslednjih 2 tednih, zatem pa kožni preskus ponovite.
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.
Bolnikom z blago do zmerno okvaro jeter je treba jasno razložiti, da je lahko obdobje, v katerem so potrebni previdnostni ukrepi, opisani v nadaljevanju, daljše od 90 dni.
MARKETING AUTHORISATION NUMBER(S) EU/1/04/272/002
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/04/272/002
This has to be balanced against the increased rate of stricture formation (see section 4.8 and section 5.1).
To je treba pretehtati glede na povečano stopnjo nastanka strikture (glejte poglavje 4.8 ter poglavje 5.1).
MARKETING AUTHORISATION NUMBER(S) EU/1/04/272/001
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/04/272/001
During your light treatment you may receive sedation.
V času zdravljenja s svetlobo lahko dobite sedative.
o Patients should be aware of potential risk factors (skin phototype and hepatic impairment).
o Bolniki morajo biti seznanjeni z možnimi nevarnostmi (fototip kože in okvare jeter).
In this case, you should avoid any activities that require mental alertness such as driving a car or using any machine.
V tem primeru se morate izogibati vsem aktivnostim, ki zahtevajo vašo pozornost, kot je na primer vožnja ali upravljanje s stroji.
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.
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.
Not known:
Ni znano:
Special care to ensure accurate PhotoBarr dosing and/or light dose is crucial, since miscalculation of either medicinal product or light dose may lead to a less effective treatment or cause detrimental effect to the patient.
Odločilna je posebna skrb za zagotavljanje točnega odmerjanja PhotoBarra in/ali odmerka svetlobe, ker lahko napačen izračun bodisi medicinskega izdelka bodisi odmerka svetlobe povzroči manj učinkovito zdravljenje ali škodljivi učinek za bolnika.
Patients should not drive or use machines after the light treatment if they have been sedated for the procedure.
Bolniki ne smejo upravljati vozil ali strojev po zdravljenju s svetlobo, če so bili pri postopku sedirani.
Pharmacovigilance Plan or risk minimisation activities
farmakovigilanco ali ukrepe za zmanjšanje tveganj.
Whenever possible, the segment selected for the first light application should include all the areas of HGD.
Kadar je možno, naj izbrani segment za prvo uporabo svetlobe zajema vsa področja HGD.
For any information about this medicine, please contact the Marketing Authorisation Holder.
Za vse nadaljnje informacije o tem zdravilu se obrnite na krajevno predstavništvo imetnika dovoljenja za promet z zdravilom.
Therefore, care should be taken to prevent extravasation at the injection site.
Zato je treba paziti, da se prepreči izliv (ekstravazacija) na mestu injiciranja.
Appetite decreased, electrolyte imbalance
Zmanjšanje teka, elektrolitsko neravnovesje
Patients with pulmonary or cardiac medical illness or a history of such illness should be treated with caution.
Bolnike z boleznijo pljuč ali srca ali s tovrstno boleznijo v anamnezi je treba previdno zdraviti.
The photosensitivity is due to residual photoactive substances, which will be present in all parts of the skin.
Občutljivost na svetlobo je posledica preostalih fotoaktivnih snovi, ki bodo prisotne na vseh delih kože.
Therefore, patients should not stay in a darkened room during this period and should be encouraged to expose their skin to ambient indoor light.
Zato v tem času bolniki ne smejo ostati v zatemnjenem prostoru, treba pa jih je tudi spodbujati, da izpostavljajo kožo okoliški svetlobi v prostoru.
Photosensitivity reactions are very common side effects of PhotoBarr (affecting more than 2 users in 3).
Fotosenzitivne reakcije so zelo pogost neželeni učinek PhotoBarra (prizadenejo več kot 2 bolnika od 3).
PhotoBarr is neither a primary ocular irritant nor a primary dermal irritant.
PhotoBarr ni niti primarni okularni iritant niti primarni dermalni iritant.
Adverse reactions reported are listed below in Table 5 by organ class and frequency.
Neželeni učinki, o katerih so poročali, so našteti spodaj v Preglednici 5 glede na vrsto organskega sistema in njihovo pogostost.
PDT specifically targets and destroys abnormal cells.
PDT cilja in uničuje spremenjene celice.
In vitro binding of porfimer sodium to human serum protein is around 90% and independent of concentration between 20 and 100 μg/ml.
In vitro vezava porfimer-natrija na človeške beljakovine v serumu je približno 90% in ni odvisna od koncentracije od 20 do 100 μg/ml.
Reproductive toxicology studies were insufficient to support the safety of porfimer sodium during pregnancy, as no light activation had been used.
Raziskave toksičnosti na reprodukcijo so bile nezadostne, da bi podpirale varnost porfimer-natrija med nosečnostjo, ker ni bila uporabljena aktivacija svetlobe.
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.
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).
Photoactivation is controlled by the total light dose delivered.
Fotoaktivacija se nadzoruje s celotnim uporabljenim odmerkom svetlobe.
Also, treating physicians should be aware of the possibility of squamous overgrowth and the risk of overlooking cancer.
Poleg tega se morajo lečeči zdravniki zavedati možnosti bujnega razraščanja ploščatega epitelija in nevarnosti, da spregledajo raka.
To increase your response rate, you may need up to three PDT courses, separated by at least 90 days.
Da bi povečali vašo stopnjo odzivnosti, boste morda potrebovali do tri cikluse PDT v razmaku najmanj 90 dni.
There is no known benefit from injecting the extravasation site with another substance.
Ni znane koristi od vbrizgavanja druge snovi na mesto ekstravazacije.
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.
Če postane zaužitje hrane in/ali pijače nemogoče, ali če se bruhanje ponavlja, je treba bolnikom svetovati, da pridejo nazaj na kliniko zaradi ocene in da po potrebi dobijo tekočino intravensko.
How to prevent a photosensitivity reaction
Kako preprečimo fotosenzitivne reakcije?
The occurrence rate rose to 32% when a second course of therapy was given, especially in the areas where second treatment overlaps the first and amounted to 10% for those who received a third treatment course.
Pogostost pojavljanja se je povečala na 32% po drugi fazi zdravljenja, zlasti v predelih, kjer se drugo zdravljenje prekriva s prvim, in se je zvečala na 10% pri tistih bolnikih, ki so bili deležni tretje faze zdravljenja.
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.
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.
Like all medicines, PhotoBarr can cause side effects, although not everybody gets them.
Kot vsa zdravila, ima lahko tudi zdravilo PhotoBarr neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Cellular damage caused by porfimer sodium PDT is a consequence of the propagation of free radical reactions.
Okvara celic, ki jo povzroči porfimer-natrij PDT, je posledica širjenja reakcij prostih radikalov.
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.
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.
If some photosensitivity reaction occurs with the limited skin test, the patient should continue exercising precautions for another 2 weeks before retesting.
Če se pri omejenem kožnem preskusu pojavi kaka fotosenzitivna reakcija, mora biti bolnik previden še naslednja 2 tedna pred ponovnim preskušanjem.
Tumour and dysplastic tissue selectivity in treatment may occur partly through selective retention of porfimer sodium but mainly through a selective delivery of light.
Selektivnost tumorjev in displastičnega tkiva pri zdravljenju lahko delno nastane s pomočjo selektivnega zadrževanja porfimer-natrija, v glavnem pa s pomočjo selektivnega oddajanja svetlobe.
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.
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 varnost zdravljenja.
You should visit your eye specialist.
Obiščite specialista za očesne bolezni.
Since PhotoBarr is activated by the red part of light, sunscreens for UV (ultraviolet) light will not protect you against photosensitivity reactions.
Ker se PhotoBarr aktivira z rdečim delom svetlobe, vas zaščitni faktorji, ki ščitijo pred UV (ultravijolično) svetlobo, ne bodo obvarovali pred fotosenzitivnimi reakcijami.
How to use PhotoBarr 4.
Kako uporabljati zdravilo PhotoBarr 4.
The frequency and nature of the photosensitivity reactions experienced in this study are unlike the documented incidence seen in previous clinical studies in cancer patients (approx. 20%) or the spontaneously reported incidence from commercial use of PhotoBarr (< 20%).
Pogostost in vrsta preobčutljivostnih reakcij na svetlobo, ki so nastale v tej raziskavi, niso take kot so pojavi, opaženi v prejšnjih kliničnih raziskavah pri rakavih bolnikih (približno 20%), ali pojavi, o katerih so spontano poročali v zvezi s komercialno uporabo PhotoBarra (< 20%).
Investigations Common:
Preiskave Pogoste:
In the PDT + OM group, 133 patients were treated.
V skupini, zdravljeni s PDT + OM, je bilo 133 bolnikov.
Porfimer sodium is a mixture of porphyrin units, which are linked together in chains of two to eight units.
Porfimer-natrij je mešanica enot porfirina, ki se med seboj vežejo v verigah po dve do osem enot.
PhotoBarr is contraindicated in patients with severe hepatic impairment.
PhotoBarr je kontraindiciran pri bolnikih s hudo jetrno okvaro.
For storage conditions of the reconstituted medicinal product, see section 6.3.
Pogoji shranjevanja pripravljenega zdravila so navedeni v razdelku 6.3.
PhotoBarr PDT causes direct intracellular damage by initiating radical chain reactions that damage intracellular membranes and mitochondria.
PhotoBarr PDT povzroči neposredno škodo v celici s tem, da sproži radikalne verižne reakcije, ki poškodujejo membrane in mitohondrije v celicah.
As a result of PDT treatment, patients may complain of substernal chest pain because of inflammatory responses within the area of treatment.
Posledica zdravljenja s PDT je, da se lahko bolniki pritožujejo nad bolečino v prsih pod grodnico zaradi vnetnih reakcij v področju zdravljenja.
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.
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.
Cut a 2-inch hole in a paper bag, put it on your hand or elbow (not your face).
V papirnato vrečko naredite približno 5 cm luknjo, ki jo nato položite na roko ali komolec (ne na obraz).
Porfimer sodium was not mutagenic in standard genotoxicity tests in the absence of light.
Porfimer-natrij ni bil mutagen v običajnih raziskavah genotoksičnosti v odsotnosti svetlobe.
As with therapeutic overdose, any accidentally overexposed person must be protected from bright light.'
Kot v primeru terapevtskega prekomernega odmerka, je treba osebo, ki je bila izdelku izpostavljena nenamerno, zaščititi pred močno svetlobo.
− Within 60 days of an important (pharmacovigilance or risk minimisation) milestone
− V roku 60 dni od doseganja pomembnega mejnika (na področju farmakovigilance ali
About 90 days after the PhotoBarr injection, you should test the photosensitivity of your skin as follows:
Po približno 90-tih dneh po injekciji PhotoBarra je treba preskusiti občutljivost kože na svetlobo, kot sledi:
remember to take protective clothing and sunglasses with you to your appointment, as you will be photosensitive once the injection has been given.
ne pozabite vzeti k zdravniku zaščitnih oblačil in sončnih očal, ker boste po aplikaciji injekcije postali občutljivi na svetlobo.
No pharmacokinetic and safety data in patients with hepatic impairment are available.
Na razpolago ni nobenih farmakokinetičnih podatkov in podatkov o varnosti za bolnike z okvaro jeter.
Weight decreased, body temperature increased
Izguba telesne teže, zvišana telesna temperatura
During this period, patients should wear dark sunglasses, which have an average white light transmittance of <4% when outdoors.
V tem času morajo bolniki nositi temna očala s povprečno prepustnostjo bele svetlobe <4% na prostem.
PhotoBarr is not recommended for use in children below age 18 years due to a lack of data on safety and efficacy.
Uporabe zdravila PhotoBarr pri otrocih, mlajših od 18 let, ni mogoče priporočiti zaradi nezadostnih podatkov o varnosti in učinkovitosti v tej starostni skupini.
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.
Pri bolnikih z BP > 7 cm je treba preostalo nezdravljeno dolžino epitelija Barrettovega požiralnika zdraviti z drugim ciklusom PDT najmanj 90 dni kasneje.
The majority of these was mild to moderate in intensity and could be managed through 1-2 dilatations.
Večina teh pojavov je bila blage do zmerne stopnje in jih je bilo mogoče odpraviti v 1-2 razširitvah (dilatacijah).
Keep out of the reach and sight of children.
Zdravilo shranjujte zunaj dosega in pogleda otrok.
Plasma samples were obtained up to 56 days (patients) or 36 days (volunteers) post injection.
Krvne vzorce so dobili do 56 dni (bolniki) ali 36 dni (prostovoljci) po injiciranju.
Based on preclinical studies, acceptable light intensity for the balloon/diffuser combination ranges from 175-270 mW/cm of diffuser.
Na podlagi predkliničnih raziskav se sprejemljiva jakost svetlobe za kombinacijo balona/difuzorja uvršča med 175 in 270 mW/cm difuzorja.
If patients travel to a different geographical area with greater sunshine, they should retest their level of photosensitivity.
Če bolniki potujejo v drugo geografsko območje, kjer je veliko sončne svetlobe, morajo ponovno preskusiti svojo stopnjo občutljivosti na svetlobo.
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.
Če se ti znaki ne pojavijo, lahko postopno začnete opravljati običajne dejavnosti na prostem in zmanjšate izpostavljenost soncu v opoldanskih urah.
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.
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.
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.
Pojavi se lahko povečano tveganje tromboembolije, še posebej pri bolnikih z dolgotrajno imobilizacijo, po večji operaciji in pri ostalih faktorjih tveganja za tromboembolijo.
Safety and efficacy in patients with treatment failure of other local mucosal ablative therapy has not been evaluated.
Varnosti in učinkovitosti pri bolnikih z neuspelim zdravljenjem z lokalno ablativno terapijo sluznice nismo ocenjevali.
Available treatment and surveillance guidelines should be considered.
Upoštevati je treba razpoložljivo zdravljenje in navodila za spremljanje bolnika.
Avoid direct exposure to bright indoor lights, including dental lamps, operating room lamps, unshaded light bulbs at close proximity or neon lights.
Izogibajte se neposredni izpostavljenosti močni notranji svetlobi vključno z zobozdravstvenimi svetilkami, lučmi v operacijskih dvoranah, nezasenčenimi žarnicami v neposredni bližini ali neonskimi lučmi.
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.
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.
There is no information on overdose of PhotoBarr.
Ni podatkov o prevelikem odmerjanju PhotoBarra.
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.
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.
The formation of oesophageal stenosis cannot be reduced or eliminated by the use of steroids.
Uporaba steroidov ne more zmanjšati ali preprečiti nastajanja stenoze.
Porfimer sodium is not dialyzable.
Porfimer-natrij ni primeren za dializo.
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.
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.
if you are not able to swallow at all or repeated vomiting occurs
- če sploh ne morete požirati ali če se bruhanje ponavlja.
Day 3a
3. dan a