natgillin/translations-raw huggingface dataset:
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
Blood albumin decreased, blood chloride increased, blood urea increased, haematocrit decreased, haemoglobin decreased, oxygen saturation decreased,
in na recept (glejte Dodatek I: Povzetek glavnih
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
− Bolniki morajo biti seznanjenimi z možnimi neželenimi učinki.
− There are a number of potential side effects that patients should be aware of.
Nosečnost
Pregnancy
Tudi poškodba tkiva je posledica ishemije, ki nastane ob vazokonstrikciji, aktivaciji in agregaciji ter strjevanju trombocitov. Raziskave na živalih
Tissue damage also results from ischaemia secondary to vasoconstriction, platelet activation and aggregation and clotting.
takoj po injiciranju 79,6 μg/ml (C.V. 61%, razpon 39-222), pri prostovoljcih pa je bil Cmax 40 μg/ml in AUCinf 2400 μg/h/ml.
In patients,the mean peak plasma concentration (Cmax) was 79.6 μg/ml (C.V. 61%, range 39-222), whereas in volunteers Cmax was 40 μg/ml and AUCinf was 2400 μg/h/ml.
Predklinične študije kažejo, da se sestavine porfimer-natrija izločajo predvsem z blatom.
Preclinical studies indicate that the excretion of porfimer sodium components occurs primarily via the faecal route.
invazivni rak požiralnika, rak v anamnezi, razen kožnega raka, ki ni bil melanom, ali če so poprej dobili PDT v požiralnik.
Patients were excluded from the study if there was a presence of invasive oesophageal cancer, if they had a history of cancer other than nonmelanoma skin cancer or if they had received prior PDT to the oesophagus.
skupinah z uporabo testa log rank je pokazala statistično pomembno razliko med krivuljama v obeh skupinah populacije ITT (p=0,0014),
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.
se uporabljajo za predhodno zdravljenje vozličkov pri dolžini difuzorja 50 J/cm pred rednim zdravljenjem z balonom pri prvem zdravljenju z lasersko svetlobo, ali za ponovno zdravljenje »izpuščenih« področij po prvem zdravljenju z lasersko svetlobo.
Short fibre optic diffusers (< 2.5 cm) are to be used to pretreat nodules with 50 J/cm diffuser length prior to regular balloon treatment in the first laser light session or for the retreatment of "skip" areas after the first light session.
Preglednica 4. Displazija visoke stopnje v Barrettovem požiralniku < 7 cm Naprave za oddajanje
High-grade dysplasia in Barrett's oesophagus of < 7 cm
PDT cilja in uničuje
PDT specifically targets and destroys abnormal cells.
s pomočjo ishemične nekroze, ki nastane kot posledica žilne okluzije, za katero se zdi, da jo delno povzroči sproščanje tromboksana A2. Lasersko zdravljenje
Tumour cell death also occurs through ischaemic necrosis secondary to vascular occlusion that appears to be partly mediated by thromboxane A2 release.
Raziskave o vplivu zdravila na sposobnost vožnje in upravljanje
4.7 Effects on ability to drive and use machines
Redko:
Rare:
Benigne, maligne in neopredeljene novotvorbe (vključno
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uncommon:
Zdravnik vam bo z endoskopom (pripravo, ki se uporablja za vpogled v določene dele telesa) apliciral rdečo lasersko svetlobo (ne vročega laserja) na zadevno mesto.
Laser light treatment: Your doctor will apply the red laser light (not a burning laser) to the involved area using an endoscope (a device used to see inside certain parts of the body).
a Kadar je mogoče, mora segment BP, izbran za zdravljenje, vključevati običajne robove tkiv nekaj milimetrov na proksimalnih in distalnih koncih.
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.
oči si zavarujte
Keep this leaflet.
PhotoBarr je kontraindiciran pri bolnikih
PhotoBarr is contraindicated in patients with severe hepatic impairment.
Za to zdravljenje se uporablja difuzor z optičnimi vlakni brez balona ter moč svetlobe 400 mW/cm. V
For this treatment, the fibre optic diffuser is used without a balloon, and a light intensity of 400 mW/cm should be used.
Učinkovitost in predvsem varnost PDT s PhotoBarrom ni bila ugotovljena pri bolnikih
Efficacy and especially safety of PDT with PhotoBarr have not been established in patients with contraindications to, or not being eligible for, oesophagectomy.
sme uporabljati med nosečnostjo, razen če je to nujno potrebno.
Porfimer sodium should not be used during pregnancy, unless clearly necessary.
in jetrne okvare na izpostavljenost porfimer-natriju ni bil ocenjen (glejte poglavja 4.2, 4.3 in 4.4).
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).
Klorovodikova kislina, natrijev hidroksid (za uravnavanje pH-vrednosti).
Hydrochloric acid, sodium hydroxide (for pH adjustment).
s številom opravljenih ciklusov PDT.
Progression to cancer was related to the number of PDT courses administered.
spremljevalni kontrolni pregled vsake tri mesece ali celo vsakih šest mesecev po tem, ko rezultati štirih zaporednih biopsij niso več pokazali
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
s PhotoBarrom PDT + OM (omeprazol), s skupino bolnikov (n=183), ki so dobivali samo OM (n=70).
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).
− Bolniki morajo zdravnika pred pričetkom zdravljenja obvestiti o morebitni hudi o Obstaja velika nevarnost nastanka fotosenzitivnih reakcij (preobčutljivosti na o Na izpostavljeni koži se lahko pojavi rdečina, ki v večini primerov pozroča nelagodje in se lahko razvije v hudo preobčutljivost na svetlobo.
− Patients should inform their doctor before they start treatment if they have severe o Remains in your body for 60-90 days after receiving the injection o There is an increased risk of photosensitivity (sensitivity to light) o Exposed skin will become red and cause discomfort in most cases but severe o Commercially available sun blocks are not effective in preventing sensitivity due to light
s PhotoBarrom PDT + OM, statistično pomembno nižji kot v skupini, zdravljeni zgolj z OM (p=0,0060).
The proportion of patients who progressed to cancer in the PhotoBarr PDT + OM group was statistically lower than in the OM only group (p=0.0060).
s PhotoBarrom mora opraviti zdravnik, ki ima izkušnje z endoskopskimi laserskimi postopki oz.
Photodynamic therapy with PhotoBarr should be performed only by, or under the supervision of, a physician with experience in endoscopic laser procedures.
Bolezni pljuč in srca
Pulmonary or cardiac disorders
Način dajanja odmerkov je na kratko prikazan v Preglednici 4. Pri bolnikih z BP > 7 cm je treba preostalo nezdravljeno dolžino epitelija Barrettovega požiralnika zdraviti z drugim ciklusom PDT najmanj
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.
- Fistule sapnika in požiralnika ali fistule bronhijev in požiralnika.
- Tracheo-oesophageal or broncho-oesophageal fistula.
Kontraktura sklepa, zmanjšani obseg gibljivosti sklepa, mišično-kostna
Joint contracture, joint range of motion decreased, musculoskeletal chest pain,
s 6,6 ml 5% raztopine glukoze za injiciranje, katere rezultat je končna koncentracija porfimer-natrija v raztopini za injiciranje 2,5 mg/ml.
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.
V kliničnih raziskavah
CLINICAL PARTICULARS
V preglednici 2
Table 2.
ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Tega zdravila ne smemo mešati z drugimi zdravili, razen
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
s tem, da sproži radikalne verižne reakcije, ki poškodujejo membrane
PhotoBarr PDT causes direct intracellular damage by initiating radical chain reactions that damage intracellular membranes and mitochondria.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 75 mg porfimer-natrija.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 75 mg porfimer sodium.
Dušenje, oteženo dihanje po naporu, hemoptiza, hipoksija, nazalna kongestija, aspiracijska pljučnica, produktivni kašelj, respiratorna depresija, kongestija
Choking, dyspnoea exertional, haemoptysis, hypoxia, nasal congestion, pneumonia aspiration, productive cough, respiratory depression, respiratory
Po pripravi zaščitite zdravilo pred svetlobo in uporabite v 3 urah.
After reconstitution, protect from light and use within 3 hours.
- Zdravilna učinkovina je porfimer-natrij.
The active substance is porfimer sodium.
Navodila za zdravstveno osebje za odmerjanje zdravila in spremljanje zdravljenja
Healthcare professionals administration and monitoring guide
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 15 mg porfimer-natrija.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 15 mg porfimer sodium.
Vpliv jetrne okvare na izpostavljenost porfimer-natriju ni bil ocenjen (glejte poglavji 4.3 in 4.4).
The influence of hepatic impairment on exposure to porfimer sodium has not been evaluated (see section 4.3 and 4.4).
− Kratek opis in razlaga Barretovega požiralnika ter visoke stopnje displazije
Patient guide − Brief background and introduction to Barrett's oesophagus and high grade
Stenoza požiralnika
Oesophageal Stenosis
o Bolnike je potrebno seznaniti z daljšim razpolovnim časom porfirinov in o o Bolniki se ne smejo izpostavljati svetlobi 60-90 dni po injiciranju.
o Patients should avoid being exposed to light for 60-90 days post-exposure.
s kratkimi (< 2,5 cm) optičnimi vlakni, nameščenim neposredno na vozličih, čemur sledi standardna uporaba balona, kot je opisano zgoraj.
Nodules are to be pre-treated at a light doses of 50 J/cm of diffuser length with a short (< 2.5 cm) fibre optic diffuser placed directly against the nodules followed by standard balloon application as described above.
Angina pektoris, atrijska fibrilacija, atrijska undulacija, pritisk v prsih
Angina pectoris, atrial fibrillation, atrial flutter, chest discomfort Vascular disorders
Bolnikom z blago do zmerno okvaro jeter je treba jasno razložiti, da je lahko obdobje, v katerem
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.
Nekardiogena prsna bolečina
Non Cardiac Chest Pain
Bolezni kože in podkožja Zelo pogoste: Fotosenzitivna reakcija Pogoste:
Very common: Photosensitivity reaction Common:
Če postane zaužitje hrane in/ali pijače nemogoče, ali če se bruhanje ponavlja, je treba bolnikom
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.
− Pomembno je, da bolniki opozorijo zdravnika, če so bili po zdravljenju
− It is important that patients tell their doctor if they get exposed to sunlight after receiving treatment with PhotoBarr.
IMETNIK DOVOLJENJA
Marketing Authorisation Holder
Izogniti se je treba profilaktični uporabi kortikosteroidov, da bi zmanjšali nastanek strikture med zdravljenjem
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.
Po pripravi - Ostale učinkovine so klorovodikova kislina in/ali natrijev hidroksid (za uravnavanje pH
The other ingredients are hydrochloric acid and/or sodium hydroxide (for pH adjustment).
Da bi izračunali odmerek svetlobe, se za vse difuzorje z optičnimi vlakni uporablja naslednja posebna odmerek svetlobe (J/cm) = izhodna moč iz difuzorja (W) x čas zdravljenja (sek)
The light dose (J/cm)= power output from diffuser (W) x treatment time (sec)
inhibitorji tromboksana A2, bi lahko zmanjšali učinkovitost PDT.
Medicinal products that decrease clotting, vasoconstriction or platelet aggregation, e.g., thromboxane A2 inhibitors, could decrease the efficacy of PDT.
IME ZDRAVILA PhotoBarr 15 mg prašek za raztopino za injiciranje
NAME OF THE MEDICINAL PRODUCT PhotoBarr 15 mg powder for solution for injection
dan
NA
(130 J/cm)
3, 5 or 7 cm balloon (130 J/cm)
Zdravljenje bolnikov
Paediatric patients
15 mg praška v viali (steklo hidrolitske skupine I, prostornina 7 ml)
15 mg powder in a vial (glass type I, 7 ml capacity) with a grey butyl stopper.
Ena viala vsebuje 15 mg porfimer-natrija.
Each vial contains 15 mg of porfimer sodium.
Posebne skupine bolnikov
Special populations
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.
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
Če se ti znaki ne pojavijo, lahko postopno začnete opravljati običajne dejavnosti na prostem in
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.
IME ZDRAVILA PhotoBarr 75 mg prašek za raztopino za injiciranje.
NAME OF THE MEDICINAL PRODUCT PhotoBarr 75 mg powder for solution for injection.
Pri dvainpetdesetih odstotkih bolnikov v skupini, ki je dobivala PDT + OM, je bil ploščatocelični epitelij normalen, medtem ko je bilo pri 59% bolnikov opaziti odsotnost displazije v primerjavi
Forty-one percent of patients showed normal squamous cell epithelium and 49% had absence of dysplasia.
Ena viala vsebuje 75 mg porfimer-natrija.
Each vial contains 75 mg of porfimer sodium.
PhotoBarr lahko draži oči in/ali kožo na močni svetlobi, ker lahko povzroči fotosenzitivnost.
However, because of its potential to induce photosensitivity, PhotoBarr might be an eye and/or skin irritant in the presence of bright light.
- razjeda na črevesju, nenormalna odprtina med sapnikom in požiralnikom - krvni strdki v žilah, blokada arterij, vnetje vene
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
Občutek vročine, rdečina na mestu injiciranja, letargija, slabost, periferni edem, bolečina, edem vdolbinice, neprenašanje toplote, oslabelost
Feeling hot, injection site erythema, lethargy, malaise, oedema peripheral, pain, pitting oedema, temperature intolerance, weakness
s PhotoBarrom je indicirano v primeru odprave displazije visoke stopnje (HGD, high-grade dysplasia) pri bolnikih z Barrettovim
Photodynamic therapy (PDT) with PhotoBarr is indicated for ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO).
Preglednica 5. Povzetek neželenih učinkov
4.8 Undesirable effects a. Summary of the safety profile
svetlobe 400 mW/cm
Light intensity (mW/cm)
Po pripravi - Ostale učinkovine so klorovodikova kislina in natrijev hidroksid (za uravnavanje pH-vrednosti).
The other ingredients are hydrochloric acid and sodium hydroxide (for pH adjustment).
Po injiciranju PhotoBarra je sledilo eno do 2 zdravljenji z lasersko svetlobo.
One or 2 laser light treatments were administered following PhotoBarr injection.
Velikost odprtine za balon (cm)
Balloon Window Length (cm)
s pomočjo fotobelilne reakcije.
How to prevent a photosensitivity reaction
Poleg
OTHER
in ob postopnem povečevanju moči laserja.
As measured by immersing the diffuser into the cuvette in the power meter and slowly increasing the laser power.
Občutljivost na svetlobo
Hypersensitivity
PhotoBarr PDT + OM je učinkovito odpravil HGD pri bolnikih z BP. V končni analizi, opravljeni po najmanj 24-mesečnem obdobju spremljanja in izvajanja kontrolnih pregledov, je statistično pomemben odstotek bolnikov (77%) v skupini, ki je dobivala PhotoBarr PDT + OM, pokazal popolno ablacijo
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).
izkaznici je predviden prostor, v katerega zdravnik vnese tip kože in
− Area in card for physician to record skin type and date of injection.
sme uporabiti, če je bil dan prevelik odmerek PhotoBarra.
Laser treatment should not be given if an overdose of PhotoBarr is administered.
Selektivnost tumorjev in displastičnega tkiva pri zdravljenju lahko delno nastane
Tumour and dysplastic tissue selectivity in treatment may occur partly through selective retention of porfimer sodium but mainly through a selective delivery of light.
Absorpcija v fotosenzibilizatorju svetlobe
Uptake of photosensitiser
Za vse nadaljnje informacije o tem zdravilu
For any information about this medicine, please contact the Marketing Authorisation Holder.
s celotnim uporabljenim odmerkom svetlobe.
Photoactivation is controlled by the total light dose delivered.
V primeru trdovratne HGD je možno nadaljnje zdravljenje (do največ treh ciklusov) (v razmaku najmanj 90 dni), da se poveča odstotek odzivov. To je treba pretehtati glede na povečano stopnjo nastanka strikture (glejte poglavje 4.8 ter poglavje 5.1).
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.
s PDT, so dobivali PhotoBarr v odmerku 2 mg/kg telesne mase
The recommended dose of PhotoBarr is 2 mg/kg body weight.
Fotodinamično zdravljenje
PhotoBarr Injection
PhotoBarra.
Porphyria.
Občasne:
Common:
svojega zdravnika, če se pojavi kar koli od naštetega:
Tell your doctor immediately: if you notice a change in your eyesight.
s skupno zmogljivostjo, ki ne presega 2,5 W.
Do not store above 25°C.
Po pripravi je PhotoBarr
BEFORE YOU USE PHOTOBARR
ter 14% v skupini, ki je dobivala samo OM (p<0,0001). Ti rezultati potrjujejo rezultate, opažene po najmanj 6-mesečnem kontrolnem pregledu, ki je pokazal ablacijo HGD pri 72% bolnikov v skupini, zdravljeni
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.
slediti korakom za pripravo in odmerjanje.
− It is important to follow exactly the correct steps for reconstitution and administration of porfimer.
Farmakoterapevtska skupina: Senzibilizatorji, ki se uporabljajo za fotodinamično/obsevalno
Pharmacotherapeutic group: Sensitizers used in photodynamic/radiation therapy, ATC code: L01XD01
- bolečine v hrbtu, bolečine v okončinah, bolečina, ki je posledica zdravljenja.
Back pain, pain in the limb
Vpliv ledvične
POSSIBLE SIDE EFFECTS
Viala 75 mg - 40 ml
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial 75 mg - 40 ml
Podrobne informacije o zdravilu
PHARMACEUTICAL PARTICULARS
s PhotoBarrom je 2-stopenjski proces. Prva stopnja je intravensko injiciranje PhotoBarr.
The first stage is the intravenous injection of PhotoBarr.
− Bolnikom je treba pojasniti, da morajo
− Patients should NOT be treated with porfimer if:
Pri enem bolniku se je pojavila smrtno nevarna dispneja, pri drugih pa ni bilo večjih težav. Po prevelikem odmerku svetlobe se lahko pričakuje povečano število
One patient experienced life-threatening dyspnoea and the others had no notable complications.
so poročali na področjih, kjer so se pojavile preobčutljivostne reakcije, kot so večja poraščenost, obarvanje kože, vozlički v koži, nagubanje kože in krhkost kože. Te pojave lahko pripišemo stanju psevdoporfirije (trenutna kožna porfirija, ki nastane zaradi zravila).
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.
NAVODILO ZA UPORABO PhotoBarr 15 mg prašek za raztopino za injiciranje Porfimer-natrij
PACKAGE LEAFLET: INFORMATION FOR THE USER PhotoBarr 15 mg powder for solution for injection Porfimer sodium
Viala 15 mg - 7 ml
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial 15 mg - 7 ml
NAVODILO ZA UPORABO PhotoBarr 75 mg prašek za raztopino za injiciranje Porfimer-natrij
PACKAGE LEAFLET: INFORMATION FOR THE USER PhotoBarr 75 mg powder for solution for injection Porfimer sodium
s pofrimer-natrijem Infekcijske in parazitske bolezni Občasne:
Musculoskeletal and connective tissue disorders Common:
PhotoBarr je rdečkastorjav prašek za raztopino za injiciranje.
What PhotoBarr looks like and contents of the pack PhotoBarr is a reddish brown powder for solution for injection.
se nahajajo nastavitve, ki se morajo uporabljati za dajanje odmerka v najkrajšem času (jakost svetlobe 270 mW/cm). Po potrebi je dodana še druga možnost (jakost svetlobe 200 mW/cm) za prilagoditev laserjev
Table 2 provides the settings that would be used to deliver the dose within the shortest time (light intensity of 270 mW/cm).
Absorpcija v fotosenzibilizatorju Fotoaktivacija
Photosensitivity skin test
s 7%
Day 5
Bolezni
Lactation
Bazalni celični karcinom, lentigo
Basal cell carcinoma, lentigo Blood and lymphatic system disorders Uncommon:
se je začela najmanj 2 dni pred injiciranjem PhotoBarra.
Co-administration of omeprazole (20 mg BID) began at least 2 days before PhotoBarr injection.
Mrzel pot, dermatitis, neobičajna poraščenost, večje nagnjenje k podplutbam, keloidna brazgotina, nočno potenje, izpuščaj, ki nastane kot posledica izpostavljenosti svetlobi, makularni izpuščaj, luskasti izpuščaj, krastavost,
Cold sweat, dermatitis, hair growth abnormal, increased tendency to bruise, keloid scar, night sweats, photosensitive rash, rash macular, rash scaly, scab,
izračun bodisi medicinskega izdelka bodisi odmerka
Pharmacovigilance Plan or risk minimisation activities
s temnimi
nausea*
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO PHOTOBARR
You should stop breast-feeding before using PhotoBarr.
s PhotoBarrom PDT.
Porfimer sodium2.
Vpliv ledvične okvare na izpostavljenost PhotoBarru ni bil ocenjen (glejte poglavje 4.3).
Renal impairment The influence of renal impairment on exposure to porfimer sodium has not been evaluated (see section
Lasersko zdravljenje se ne
If you miss the laser light treatment
V nadzorovanem kliničnem preskušanju
Clinical efficacy
s potopitvijo difuzorja v kiveto v merilniku jakosti
aAs measured by immersing the diffuser into the cuvette in the power meter and slowly increasing the laser power.
Opomba:
In this leaflet:
skupaj z lokalnim anestetikom
You will be given a sedative along with a local anaesthetic, to minimise discomfort
Neznana:
Uncommon:
V nadzorovanem kliničnem preskušanju so primerjali skupino bolnikov (n=183), zdravljenih s PhotoBarrom PDT + OM (omeprazol), s skupino bolnikov (n=70), ki so dobivali samo OM. Bolniki, primerni za to raziskavo, so morali imeti z biopsijo potrjeno HGD v Barrettovem požiralniku (BP).
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.
Imetnik dovoljenja za promet z zdravilom se mora o podrobnostih glede izobraževalnega gradiva dogovoriti
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Porfimer-natrij se ne
- Porphyria.