qanastek/EMEA-V3 huggingface dataset:
Healthcare professional’ s administration and monitoring guide − It is important to follow exactly the correct steps for reconstitution and administration of porfimer. − It is important to have an appropriate light dose and a proper setting for the laser. − Any unused product or waste material should be disposed of in accordance with local requirements. − Healthcare professionals should be aware of side effects that may arise during or shortly after treatment, and how to treat them. − Patients should be warned of the possibility of long term side effects, especially photosensitivity, and the need to seek medical assistance if they arise. − Record the patient’ s skin type and the date of injection on the patient alert card
Pazjenti għandhom jingħataw twissija dwar il- possibilità ta ’ effetti kollaterali fuq tul ta ’ żmien, speċjalment fotosensittività, u l- bżonn ta ’ assistenza medika jekk ikun hemm bżonn.
Patient alert card − The need to show this card to any doctor treating them − That PhotoBarr o Remains in your body for 60-90 days after receiving the injection o Is activated by visible light 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 cases of photosensitivity are possible o Commercially available sun blocks are not effective in preventing sensitivity due to light o Photosensitivity can only be prevented by avoiding exposure to the sun for 90 days after receiving the PhotoBarr injection
Fotosensittività tista ’ tiġi evitata billi ma jkunx hemm espożizzjoni o għax- xemx għal 90 jum wara li tirċievi injezzjoni ta ’ PhotoBarr
− You should not be treated with PhotoBarr if you have severe liver disease (eg cirrhosis) − You should be screened for skin type − Area in card for physician to record skin type and date of injection.
M’ għandekx tiġi trattat b’ PhotoBarr jekk għandek mard tal- fwied sever (eż. cirrosi)
Patient guide − Brief background and introduction to Barrett’ s oesophagus and high grade dysplasia − What photodynamic therapy is − Patients should inform their doctor before they start treatment if they have severe hepatic disease. − That PhotoBarr o Remains in your body for 60-90 days after receiving the injection o Is activated by visible light 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 cases of photosensitivity are possible o Commercially available sun blocks are not effective in preventing sensitivity due to light − Photosensitivity can only be prevented by avoiding exposure to the sun for 90 days after receiving the PhotoBarr injection − It is important that patients tell their doctor if they get exposed to sunlight after receiving treatment with PhotoBarr. − There are a number of potential side effects that patients should be aware of.
Li PhotoBarr o Jibqa ’ fil- ġisem tiegħek għal 60- 90 jum wara li tirċievi l- injezzjoni o Jiġi attivat bid- dawl viżibbli o Hemm riskju ogħla ta ’ fotosensittività (sensittività għad- dawl) o Il- ġilda esposta ser issir ħamra u tikkawża skonfort f’ ħafna każijiet imma każijiet severi ta ’ fotosensittività huma possibbli o Sun blocks kummerċjalment disponibbli m’ humiex effettivi biex jevitaw is- sensittività minħabba d- dawl.
PhotoBarr 15 mg powder for solution for injection
PhotoBarr 15 mg trab għal soluzzjoni għall- injezzjoni.
Each vial contains 15 mg porfimer sodium.
Kull kunjett fih 15 mg porfimer sodium.
After reconstitution, each ml solution contains 2.5 mg porfimer sodium.
Wara r- rikostituzzjoni, kull ml ta ’ soluzzjoni fiha 2. 5 mg porfimer sodium.
A dark red to reddish brown lyophilised powder or cake.
Trab jew kejk ta ’ kulur ħamrani skur għal kannella fl- aħmari.
Photodynamic therapy (PDT) with PhotoBarr is indicated for ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO).
Terapija fotodinamika (PDT) permezz ta ’ PhotoBarr hija intiża għal asportazzjoni ta ’ displasja qawwija (HGD) f’ pazjenti li għandhom Esofagu ta ’ Barrett (BO).
Photodynamic therapy with PhotoBarr should be performed only by, or under the supervision of, a physician with experience in endoscopic laser procedures.
Terapija fotodinamika permezz ta ’ PhotoBarr trid issir biss minn tabib b’ esperjenza fl- użu tal- proċeduri tal- laser endoskopiku, jew inkella taħt is- sorveljanza tiegħu.
Posology The recommended dose of PhotoBarr is 2 mg/ kg body weight.
Pożoloġija Id- doża rakkomandata ta ’ PhotoBarr hi ta ’ 2 mg/ kg piż tal- ġisem
Reconstituted PhotoBarr solution (ml) = Patient's weight (kg) x 2 mg/ kg = 0.8 x patient's weight 2.5 mg/ ml
Soluzzjoni ta ’ PhotoBarr rikostitwita (ml) = Piż tal- ġisem tal- pazjent (kg) x2 mg/ kg=0. 8 x piż tal- ġisem 2. 5 mg/ ml
After reconstitution, PhotoBarr is a dark red to reddish brown, opaque solution.
Wara r- rikostituzzjoni, PhotoBarr hu soluzzjoni opaka ta ’ lewn ħamrani skur għal kannella fl- aħmar.
Only a solution without particles should be used and without visible signs of deterioration.
Soluzzjoni mingħajr frak u mingħajr sinjali ta ’ deterjorament biss għandha tintuża.
Photodynamic therapy with PhotoBarr is a two-stage process requiring administration of both medicinal product and light.
It- terapija fotodinamika permezz ta ’ PhotoBarr hija maqsuma f’ żewġ stadji, u tirrikjedi li jingħata kemm prodott mediċinali kif ukoll dawl.
One course of PDT consists of one injection plus one or two light applications.
Kors wieħed ta ’ PDT jikkonsisti minn injezzjoni waħda u applikazzjoni waħda jew tnejn tad- dawl.
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.
Fil- każ li l- HGD jibqa ’ jippersisti, jistgħu jingħataw aktar korsijiet (sa massimu ta ’ tliet korsijiet) ta ’ trattament (li bejniethom irid ikun hemm tal- anqas 90 jum bejniethom) sabiex ir- rata ta ’ rispons tkun ogħla.
This has to be balanced against the increased rate of stricture formation (see section 4.8 and section 5.1).
(ara sezzjonijiet 4. 8 u 5. 1)
Progression to cancer was related to the number of PDT courses administered.
Il- progress għal kanċer kien relatat mal- għadd ta ’ korsijiet ta ’ PDT mogħtija.
39% and 11% respectively)
Pazjenti li rċevew kors wieħed ta ’ PDT kellhom riskju ogħla ta ’ firxa għal kanċer milli dawk li rċevew żewġ jew tliet korsijiet ta ’ PDT (50% kontra 39% u 11% rispettivament).
2 Method of administration For instructions on reconstitution prior to administration, see section 6.6.
Mod ta ’ amministrazzjoni Għal struzzjonijiet dwar ir- rikostituzzjoni qabel l- għoti, ara sezzjoni 6. 6.
Physicians should be trained in the use of PDT.
2 It- tobba għandhom ikunu mħarrġin fl- użu ta ’ terapija fotodinamika.
The first stage of PDT is the slow intravenous injection of PhotoBarr.
L- ewwel parti ta ’ din it- terapija tikkonsisti f’ injezzjoni ġol- vina bil- mod ta ’ PhotoBarr.
The second stage of therapy is illumination with laser light 40-50 hours following injection with PhotoBarr.
Waqt it- tieni parti tat- terapija jkun hemm illuminazzjoni bid- dawl laser.
Patients may receive a second laser light application 96-120 hours after administration.
Il- pazjenti jistgħu jerġgħu jingħataw it- tieni illuminazzjoni bil- laser 96- 120 siegħa wara li jkun ingħata PhotoBarr.
PhotoBarr should be administered as a single slow intravenous injection over 3 to 5 minutes.
L- injezzjoni ddum tingħata 'l fuq minn 3 minuti sa 5 minuti.
If accidentally injected paravenously there may be damage to paravenous tissue.
Jekk bi żball ma jingħatax fil- vina, jista ’ jkun hemm ħsara fit- tessut ta ’ madwar il- vina.
Therefore, care should be taken to prevent extravasation at the injection site.
Għalhekk, attenzjoni għandha tingħata sabiex ma jkunx hemm ekstravażjoni fis- sit tal- injezzjoni.
If extravasation does occur, the area should be protected from light for a minimum of 90 days.
F’ każ ta ’ ekstravażjoni, l- erja trid tiġi mħarsa mid- dawl għal mill- anqas 90 jum.
There is no known benefit from injecting the extravasation site with another substance.
Ma jidhirx li jkun ta ’ ġid li tingħata injezzjoni ta ’ xi sustanza oħra fil- post tal- estravażjoni.
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.
Id- dawl jiġi diffuż permezz ta ’ fibra ottika li jgħaddi minn kanal ċentrali li hemm f’ bużżieqa, li isservi biex it - tessut isserraħ fuqha.
The choice of fibre optic/ balloon diffuser combination will depend on the length of oesophagus to be treated (Table 1).
L- għażla ta ’ tagħmir ta ’ kombinazzjoni ta ’ diffużur ta ’ fibra ottika, u bużżieqa, tiddependi fuq it- tul tal- esofagu li jkun ser jiġi ttrattat (Tabella 1).
Fibre optic diffuser/ balloon combinationa
Diffużur tal- fibra ottika, flimkien mal- bużżieqaa
Treated Barrett's mucosa length (cm)
fl- esofagu ta ’ Barrett li jkun trattat (ċm)
Fibre optic diffuser size (cm)
tal- fibra ottika (ċm)
Balloon window size (cm)
tal- bużżieqa (ċm)
Whenever possible, the BO segment selected for treatment should include normal tissue margins of a few millimetres at the proximal and distal ends.
Fejn possibli, il- parti tal- esofagu ta ’ Barrett li jkun se jiġi ttrattat, għandu jkollu burduri ta ’ tessut normali, ta ’ ftit millimetri fuq in- naħa ta ’ quddiem u ta ’ wara.
Light doses Photoactivation is controlled by the total light dose delivered.
Dożi ta ’ dawl L- attivazzjoni bid- dawl hija kkontrollata bid- doża tad- dawl fornuta.
The objective is to expose and treat all areas of HGD and the entire length of BO.
L- għan huwa li ż- żoni ta ’ HGD u t- tul kollu tal- esofagu ta ’ Barrett jiġu esposti għad- dawl u ttrattati.
The light dose administered will be 130 Joules/ cm (J/ cm) of diffuser length using a centring balloon.
Id- doża ta ’ dawl tkun ta ’ 130 Joules/ ċm (J/ ċm) ta ’ tul tad- diffużur meta tintuża bużżieqa li tiċċentra.
Based on preclinical studies, acceptable light intensity for the balloon/ diffuser combination ranges from 175-270 mW/ cm of diffuser.
Skond stħarriġ ta ’ qabel l- użu kliniku, l- intensità tad- dawl aċċettata meta jintuża d- diffużur flimkien mal- bużżieqa, għandha tkun fuq medda ta ’ 175- 270 mW/ ċm ta ’ diffużur.
To calculate the light dose, the following specific light dosimetry equation applies for all fibre optic diffusers:
Biex tikkalkola d- doża tad- dawl, il- formula dożimetrika li ġejja tintuża għal kull diffużur li jaħdem fil - fibra ottika:
The light dose (J/ cm) = power output from diffuser (W) x treatment time (sec) Diffuser length (cm)
Id- doża tad- dawl (J/ ċm) = Rata ta ’ enerġija li toħroġ mid- diffużur (W) x żmien tat- trattament (sec) Tul tad- diffużur (ċm)
Table 2 provides the settings that would be used to deliver the dose within the shortest time (light intensity of 270 mW/ cm).
Tabella 2 turi l- aġġustamenti biex tingħata doża fl- anqas ħin (b’ intensità tad- dawl ta ’ 270 mW/ ċm).
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.
It - tieni għazla (b’ intensità tad- dawl ta ’ 200 mW/ ċm) ġiet inkluża biex jiġu aġġustati tagħmir tal- laser li għandhom kapaċità totali li ma ’ taqbiżx 2. 5 W.
Table 2.
TABELLA 2.
Fibre optic power outputs and treatment times required to deliver 130 J/ cm of diffuser length using the centring balloon Balloon Window
Qis tal- kanal Tul tal -
Diffuser Length
Intensità
Light Intensity
Rata ta ’
Required Power Treatment Output from Time (sec) a
Tul
Treatment Time
Tul
Length (cm) (cm)
tal- bużżieqa - apparat
(mW/ cm)
tad- dawl
Diffuser (W)
enerġija meħtieġaa (W)
(min: sec)
(ċm) (ċm)
3 5
nt (min: sec) ent (sec) 3 5
As measured by immersing the diffuser into the cuvette in the power meter and slowly increasing the laser power.
Kif mkejla bit- tagħmir li jkejjel l- enerġija wara li jiġi mgħaddas id- diffużur u miżjud bil- mod il- qawwa tal- laser.
No more than 1.5 times the required diffuser power output should be needed from the laser.
Il- qawwa tal- laser meħtieġa mhux suppost tkun aktar minn 1. 5 darba aktar minn dik li toħroġ mid- diffużur.
If more than this is required, the system should be checked.
Jekk ikun hemm bżonn ta ’ aktar minn hekk, is- sistema għandha tiġi ċċekjata.
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.
Diffużuri tal- fibra ottika qosra (≤ 2. 5 ċm) jintużaw fuq għoqod ta ’ tumuri żgħar b’ rata ta ’ 50 J/ ċm ta ’ tul tal- apparat, qabel l- ewwel trattament regolari bil- bużżieqa waqt l- ewwel espożizzjoni b’ laser.
For this treatment, the fibre optic diffuser is used without a balloon, and a light intensity of 400 mW/ cm should be used.
F’ dan it- trattament, id- diffużur tal - fibra ottika, jintuża mingħajr bużżieqa, u b’ intensità tad- dawl ta ’ 400 mW/ ċm.
Table 3 lists appropriate fibre optic power outputs and treatment times using a light intensity of 400 mW/ cm.
Tabella 3 turi r- rata tal - enerġija li toħroġ mill- apparat tal- fibra ottika, kif ukoll it- tul ta ’ żmien ta ’ trattament meta l- intensità tad- dawl tkun 400 mW/ ċm.
Short fibre optic diffusers to be used without a centering balloon to deliver 50 J/ cm of diffuser length at a light intensity of 400 mW/ cm
Tabella 3. Diffużuri bil- fibra ottika qosra li jintużaw mingħajr bużżieqa li tiċċentra, biex ifornu 50 J/ ċm ta ’ tul tad- diffużur, b’ intensità ta ’ dawl ta ’ 400 mW/ ċm
Diffuser
Tul tad- diffużur
Required power
Rata ta ’ enerġija meħtieġa mid- diffużura (W)
Treatment time Treatment time
Tul tat- trattament
length (cm)
Tul tat - trattament
output from diffusera (W)
(ċm)
First light application A maximum of 7 cm of Barrett's mucosa is treated at the first light session using an appropriate size of centering balloon and fibre optic diffuser (Table 1).
L- ewwel espożizzjoni għad- dawl Waqt l- ewwel sessjoni bid- dawl jiġi ttrattat tul massimu ta ’ 7 ċm ta ’ mukoża ta ’ Barrett, u jintużaw bużżieqa u diffużur tal- fibra ottika, ta ’ qis xieraq (Tabella 1).
Whenever possible, the segment selected for the first light application should include all the areas of HGD.
Fejn possibbli, il- parti magħżula li trid tiġi ttrattata bid- dawl, għandha jkun fiha zoni ta ’ HGD.
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.
Barra dan, fejn possibli, il- parti tal- esofagu ta ’ Barrett li tkun ser tiġi ttrattata, għandha jkollha burduri ta ’ ftit millimetri tessut normali fuq in- naħa ta ’ quddiem u ta ’ wara.
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.
Qabel it- trattament ewlieni, għoqod ta ’ tumuri żgħar għandhom jiġu ttrattati b’ dożi ta ’ dawl ta ’ 50 J/ ċm ta ’ tul tad- diffużur F’ dan il- każ jintuża diffużur tal- fibra ottika qasira (≤ 2. 5 ċm), li jitqiegħed direttament bi dritt l- għoqod.
Repeat light application 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).
Fit- tieni trattament jintuża diffużur tal- fibra ottika qasira ta ’ ≤ 2. 5 ċm u b’ doża ta ’ dawl ta ’ 50 J/ ċm ta ’ tul tal - apparat (ara Tabella 3).
The treatment regimen is summarized in Table 4.
Il- kors tat- trattament huwa spjegat fil- qosor f ’ Tabella 4.
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.
Pazjenti b ’ esofagu ta ’ Barrett > 7 ċm, għandu jkollhom il- kumplament tal- epitelju ta ’ Barrett li ma jintlaħaqx fl- ewwel trattament, ittrattat b ’ kors ieħor ta ’ terapija fotodinamika, tal- anqas 90 jum wara.
Table 4.
TABELLA 4.
High-grade dysplasia in Barrett's oesophagus of < 7 cm
Displasja qawwija fl- esofagu ta ’ Barrett li huwa ≤ 7 ċm
Procedure PhotoBarr Injection
Injezzjoni PhotoBarr
Study day Day 1
Jum 1 Jum 3a
Light delivery Devices NA
Mhux applikabbli
Treatment intent Uptake of photosensitiser
Jittieħed il - fotosensitizzatur
Laser Light Application
Espożizzjoni għad- dawl laser
3, 5 or 7 cm balloon (130 J/ cm)
Bużżieqa ta ’ 3, 5 jew 7 ċm (130 J/ ċm)
Photoactivation
Attivazzjoni bid- dawl
Laser Light Application a
Espożizzjoni għad- dawl laser
Day 5
Jum 5
Short (< 2.5 cm) fibre optic diffuser (50 J/ cm)
Diffużur qasir (≤ 2. 5 ċm) tal- fibra ottika (50 J/ ċm)
Treatment of "skip" areas only
Trattament biss taż- żoni maqbuża
Discrete nodules will receive an initial light application of 50 J/ cm (using short diffuser) before the balloon light application.
4 a Għoqod diskreti jingħataw doża ta ’ dawl ta ’ 50 J/ ċm (jintuża diffuiżur qasir) fil- bidu qabel l- użu bid- dawl permezz tal- bużżieqa u l- apparat regolari.
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
Il- pazjenti jistgħu jingħataw it- tieni kors ta ’ PDT mill- anqas 90 jum wara l- ewwel terapija.
4 previously treated segment which still shows HGD or to a new segment if the initial Barrett's segment was > 7 cm in length.
Huma jistgħu jingħataw sa tlett korsijiet ta ’ terapija fotodinamika (kull injezzjoni tingħata mill- anqas 90 jum wara ta ’ qabel) fuq l- istess parti li tkun ġiet trattata qabel li tkun għadha turi HGD, kif ukoll meta l - parti ta ’ Barrett tkun oriġinalment > 7 ċm fit- tul.
Both residual and additional segments may be treated in the same light session(s) if the total length of the segments treated with the balloon/ diffuser combination is not greater than 7 cm.
Kemm partijiet li jkun fadal jew partijiet oħrajn, jistgħu jiġu ittrattati fl- istess sessjoni (jiet) tat- trattament bid- dawl, jekk it- tul totali tal- partijiet ittrattati bil- kombinazzjoni ta ’ bużżieqa u diffużur, ma jkunux akbar minn 7 ċm.
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.
F ’ każ li parti mill- esofagu tkun diġà ġiet trattata u ma tkunx tfiqet, u/ jew ir- riżultat istoloġiku ta ’ biopsiji ma ’ jkunx ċar, jista ’ jkun hemm differiment ta ’ xahar jew xahrejn fil- kors ta ’ terapija fotodinamika li jkun imiss.
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.
Attenzjoni speċjali sabiex jiġi żgurat dożi tajba ta ’ PhotoBarr u/ jew dawl, hija kruċjali imbilli dożi ħżiena fil- prodott mediċinali jew f’ espożizzjoni għad- dawl, jistgħu jikkaġunaw trattament anqas effettiv jew ħsara lil pazjent.
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.
It- terapija fotodinamika b’ PhotoBarr għandha tingħata minn tobba mħarrġa fl- użu endoskopiku waqt it- terapija fotodinamika.
Paediatric patients PhotoBarr is not recommended for use in children below age 18 years due to a lack of data on safety and efficacy.
Popolazzjonijiet speċifiċi Pazjenti pedjatriċi PhotoBarr mhux irrakomandat għall- użu fit- tfal jew l- adoloxxenti taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja
Elderly patients (≥ 65 years old) Dose modification based upon age is not required.
Pazjenti anzjani (> 65 sena) Mhux meħtieġ li d- doża tiġi aġġustata minħabba l- età.
Renal impairment The influence of renal impairment on exposure to porfimer sodium has not been evaluated (see section 4.3).
Indeboliment fil- kliewi L- influwenza ta ’ indeboliment fil- kliewi minħabba l- espożizzjoni għal porfimer sodium ma ġietx evalwata (ara sezzjoni 4. 3).
Hepatic impairment The influence of hepatic impairment on exposure to porfimer sodium has not been evaluated (see section 4.3 and 4.4).
Indeboliment fil- fwied L- influwenza ta ’ indeboliment fil- fwied minħabba l- espożizzjoni għal porfimer sodium ma ġietx evalwata (ara sezzjonijiet 4. 3 u 4. 4)
Hypersensitivity to the active substance, other porphyrins or to any of the excipients.
Sensittività eċċessiva għas- sustanza attiva jew għal porfirini oħra jew għal xi sustanzi mhux attivi.
Porphyria.
Porfirja
Severe renal and/ or hepatic impairment.
Indeboliment qawwi fil- fwied u/ jew kliewi.
Oesophageal or gastric varices or patients with oesophageal ulcers > 1 cm in diameter.
Variċi fl- esofagu jew fl- istonku jew ulċeri fl- esofagu b’ dijametru > 1 ċm.
Tracheo-oesophageal or broncho-oesophageal fistula.
Fistula fit- trakea- esofagali jew bronko- esofagali.
Suspected erosion of major blood vessels due to risk of massive, potentially fatal haemorrhage.
Ħjiel ta ’ tgħawwir fil- vażi tad- demm maġġuri minħabba riskju ta ’ emorraġija serja li tista ’ tkun fatali.
Efficacy and especially safety of PDT with PhotoBarr have not been established in patients with contraindications to, or not being eligible for, oesophagectomy.
L- effikaċja u fuq kollox is- sigurtà ta ’ meta tingħata terapija fotodinamika b’ PhotoBarr, ma ġewx mistħarrġa f’ pazjenti li huma kontraindikati jew mhux eliġibli għal esofagotomija.
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.
It- terapija fotodinamika b’ PhotoBarr ġiet mistħarrġa biss f’ pazjenti li ma ’ kellhomx mard serju, bħal insuffiċjenza kardijaka konġestiva fi stadju avvanzat, jew mard serju fil- pulmun li jista ’ jinibixxi l - pazjent minn intervent kirurġiku.
In clinical trials, PhotoBarr PDT has only been tested in patients being treatment naive concerning mucosal ablative therapy.
5 Terapija fotodinamika b’ PhotoBarr ġiet ippruvata waqt provi kliniċi fuq pazjenti mhux konxji mit- trattament ta ’ asportazzjoni mukuża.
Safety and efficacy in patients with treatment failure of other local mucosal ablative therapy has not been evaluated.
Ma ġewx mistħarrġa s- sigurtà u l- effikaċja f’ pazjenti li ma rnexxewlhomx trattamenti lokali oħrajn ta ’ asportazzjoni mukuża.
5 Patients older than 75 years may be at a higher risk of respiratory related adverse events such as pleural effusion and dyspnoea.
Pazjenti li għandhom iktar minn minn 75 sena jista ’ jkollhom riskju akbar minħabba effetti avversi fis- sistema respiratorja, bħal effużjoni plewrali u qtugħ ta ’ nifs.
Pulmonary or cardiac disorders Patients with pulmonary or cardiac medical illness or a history of such illness should be treated with caution.
Disturbi pulmonari jew kardijaċi Pazjenti li għandhom mard mediku fil- pulmun jew fil- qalb, jew storja medika ta ’ din ix- xorta, għandhom jiġu ttrattati b ’ kawtela.
These patients may be at higher risk for the development of cardiac and pulmonary related adverse events such as heart rhythm disorders, angina pectoris, dyspnoea, cough, pleural effusion, pharyngitis, atelectasis and events like dehydration (see also section 4.8).
Dawn il- pazjenti jistgħu jkunu f’ riskju ogħla li jiżviluppaw problemi fil- qalb jew fil- fwied, bħal mard li jaffettwa t- taħbit tal- qalb, angina pectoris, qtugħ ta ’ nifs, sogħla, effużjoni plewrali, atelektażi, kif ukoll każijiet ta ’ deidratazzjoni (ara ukoll sezzjoni 4. 8).
Photosensitivity All patients who receive PhotoBarr will be photosensitive and must observe precautions to avoid exposure of skin and eyes to direct sunlight or bright indoor light (from examination lamps, including dental lamps, operating room lamps, unshaded light bulbs at close proximity, neon lights, etc.) for at least 90 days after treatment, as some patients may remain photosensitive for up to 90 days or more.
Għalhekk għandhom jieħdu prekawzjonijiet kontra l- espożizzjoni tal- ġilda u l- għajnejn mid- dawl dirett tax- xemx jew dawl minn lampi qawwija (lampi li jintużaw biex jeżaminaw, inklużi lampi tad- dentist, lampi tal- kamra tal - interventi kirurġiċi, bozoz mikxufa mill- viċin, dawl neon, eċċ.).
During this period, patients should wear dark sunglasses, which have an average white light transmittance of < 4% when outdoors.
Tul dan il- perijodu, il- pazjenti għandhom jilbsu nuċċali tax - xemx skur, li bħala medja jittrażmetti dawl abjad < 4% meta jkunu barra.
The photosensitivity is due to residual photoactive substances, which will be present in all parts of the skin.
Din is- sensittività eċċessiva għad- dawl hija minħabba sustanzi fotoattivi li jibqgħu preżenti fil- ġilda kollha.
Exposure of the skin to ambient indoor light is, however, beneficial because the remaining medicinal product will be inactivated gradually through a photo- bleaching reaction.
Madankollu, l - espożizzjoni tal- ġilda għal dawl ambjentali ġewwa d- dar, hija ta ’ ġid, għax b ’ hekk id- droga żejda tiġi nnewtralizzata bid- dawl.
Therefore, patients should not stay in a darkened room during this period and should be encouraged to expose their skin to ambient indoor light.
Għalhekk, il- pazjenti m’ għandhomx joqgħodu fi kmamar mudlama f’ dan iż - żmien, u għandhom jiġu mħajjra jesponu l- ġilda għad- dawl ambjentali ta ’ ġewwa.
The level of photosensitivity will vary for different areas of the body, depending on the extent of previous exposure to light.
Ir- reazzjoni tal - ġilda għad- dawl tvarja skondil- parti tal- ġisem, u tiddependi fuq kemm il- ġilda tkun ġiet esposta għad - dawl qabel.
Before exposing any area of skin to direct sunlight or bright indoor light, the patient should test it for residual photosensitivity.
Qabel tinkixef parti mill- ġilda fid- dawl dirett tax- xemx jew dawl qawwi ieħor, il- pazjent għandu l- ewwel jiċċekkja li m’ għadhux sensittiv għad- dawl b’ mod eċċessiv.
A small area of skin should be exposed to sunlight for 10 minutes.
Parti żgħira mill- ġilda għandha tkun esposta għad- dawl tax- xemx għal 10 minuti.
The tissue around the eyes may be more sensitive, and therefore, it is not recommended that the face be used for testing.
It- tessut ta ’ madwar l- għajnejn jista ’ jkun aktar sensittiv, u għalhekk mhux rakkomandat li jintuża l- wiċċ biex tiċċekkja għas- sensittività.
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.
Fil- bidu, dan isir b ’ kawtela u l- espożizzjoni tiżdied gradwalment.
If some photosensitivity reaction occurs with the limited skin test, the patient should continue exercising precautions for another 2 weeks before retesting.
Il- pazjent għandu jibqa ’ jieħu l- prekawzjonijiet meħtieġa u jerġa ’ jiċċekja l- ġilda ġimagħtejn wara jekk ikun hemm sensittività eċċessiva għad- dawl meta l- pazjent jiċċekkja fuq parti żgħira tal- ġilda.
If patients travel to a different geographical area with greater sunshine, they should retest their level of photosensitivity.
Il - pazjent għandu jerġa ’ jirrepeti dan it- test kemm- il darba jmur f ’ post aktar xemxi.
Conventional UV (ultraviolet) sunscreens are of no value in protecting against photosensitivity reactions because photoactivation is caused by visible light.
Dlik konvenzjonali ta ’ kontra r- raġġi UV (ultraviolet) ma jipproteġix kontra reazzjonijiet kkaġunati minħabba sensittività eċċessiva għad- dawl.
Hepatic impairment No pharmacokinetic and safety data in patients with hepatic impairment are available.
Indeboliment epatiku Ebda tagħrif farmakokinetiku u dwar is- sigurtà f’ pazjenti b’ indeboliment epatiku mhu disponibbli.
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.
Skond evidenza għal eliminazzjoni epatika/ jew mill- marrara primarja ta ’ sustanzi fotoattivi, is- severità ta ’ reazzjonijiet fototossiċi u t- tul ta ’ żmien ta ’ fotosensittività f’ pazjenti b’ xi grad ta ’ indebolment epatiku jista ’ jiżdied.
PhotoBarr is contraindicated in patients with severe hepatic impairment.
PhotoBarr huwa kontraindikat f’ pazjenti b’ indeboliment epatiku sever.
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.
Pazjenti b’ indeboliment epatiku minn ħafif sa sever għandhom jiġu mogħtija struzzjonijiet ċari li l- perijodu meħtieġ għal miżuri prekawzjonarji deskritti hawn isfel jistgħu jdumu gal aktar minn 90 jum.
Patients should be advised to consult their ophthalmologist if they notice any vision changes after treatment with PhotoBarr PDT.
Il- pazjenti għandhom jingħataw parir sabiex jikkonsultaw mal- oftalmologu tagħhom jekk jindunaw b’ xi tibdil fil- vista wara li jkunu ġew ittrattati bit- terapija fotodinamika ta ’ PhotoBarr.
As a result of PDT treatment, patients may complain of substernal chest pain because of inflammatory responses within the area of treatment.
Dan minħabba infjammazzjoni li tiżviluppa fil- parti ttrattata.
Such pain may be of sufficient intensity to warrant the short- term prescription of opiate analgesics.
Dan l- uġigħ jista ’ jkun tant qawwi li jiġġustifika l- ħruġ ta ’ riċetta għal żmien qasir, għal analġeżiċi narkotiċi sabiex l- uġigħ jitaffa ’.
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.
Dan għaliex ġie ppruvat li ma jaħdmux, u jistgħu jaggravaw is- sitwazzjoni.
PhotoBarr PDT regularly causes dysphagia, odynophagia, nausea and vomiting.
6 It- terapija fotodinamika b’ PhotoBarr regolarment tikkaġuna disfaġja, odinofaġja, dardir, u rimettar.
Therefore, patients should be advised to receive liquid food during the first days (up to 4 weeks) after the laser light application.
Għalhekk, il- pazjenti għandhom ikunu mwissija biex jieħdu ikel likwidu fl- ewwel jiem (sa 4 ġimgħat) wara t- trattament bid- dawl laser.
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.
Jekk il- pazjenti ma jkunux jistgħu jżommu l- ikel jew/ u x- xorb, minħabba rimettar bla waqfien, huma għandhom imorru l- klinika biex jiġu eżaminati u jekk meħtieġ jingħataw likwidi ġol- vina.
6 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.
Jekk terapija fotodinamika tkun ser tingħata qabel jew wara radjoterapija, għandu jgħaddi żmien biżżejjed bejn iż- żewġ trattamenti biex jiġi żgurat li l- infjammazzjoni kkaġunata mill- ewwel trattament tkun marret, qabel jinbeda t- tieni wieħed.
Data on the long-term effect of PhotoBarr (beyond two years) are not available at the moment.
Attwalment, m’ hemmx tagħrif fuq l- effetti fit- tul ta ’ PhotoBarr (’ il fuq minn sentejn).
Also, treating physicians should be aware of the possibility of squamous overgrowth and the risk of overlooking cancer.
Importanti wkoll li t- tobba li jagħtu dan it- trattament ikunu konxji dwar il- possibbiltà ta ’ zvilupp żejjed ta ’ qxur, kif ukoll ir- riskju li ma jarawx sintomi ta ’ kanċer.
Therefore, adequate and rigorous surveillance should be continued despite possible endoscopic partial or complete restitution of the normal squamous mucosa.
Għalhekk, għandha titkompla s- sorveljanza xierqa u b’ reqqa, anke jekk l- eżami endoskopu juri li hemm fejqan parzjali jew sħiħ tat- tessut mukuż squamous.
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).
Fl- istudji kliniċi b’ Photobarr, sorveljanza fuq il- pazjenti kienet ssir kull tlett xhur, jew kull sitt xhur wara li jkunu ttieħdu r- riżultati tal- biopsija għal erba ’ darbiet u ntwera ’ u ma hemmx sinjali ta ’ displasja qawwija aktar (ara sezzjoni 5. 1).
Available treatment and surveillance guidelines should be considered.
Għandhom jiġu kkunsidrati l- linji gwida disponibbli dwar trattament u sorveljanza.
No formal interaction studies have been performed with PhotoBarr investigating pharmacokinetic interactions with other medicinal products.
Ma kien hemm l- ebda studju formali dwar kif prodotti mediċinali – prodott mediċinali ieħor u PhotoBarr jaffettwaw il- kwalitajiet farmakokinetiċi ta ’ xulxin.
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.
Stħarriġ farmakodinamiku wera li meta jingħataw kortikosterojdi qabel jew ma ’ terapija fotodinamika, bi skop biex inaqqsu t- tidjieq, is- sigurtà tat- trattament tista ’ titbaxxa.
It is possible that concomitant use of other photosensitising agents (e. g., tetracyclines, sulphonamides, phenothiazines, sulphonylurea hypoglycaemic agents, thiazide diuretics, griseofulvin and fluoroquinolones) could increase the photosensitivity reaction.
Hemm possibbiltà li l- użu ta ’ PhotoBarr flimkien ma ’ sustanzi li jikkaġunaw sensittività eċċessiva għad- dawl (eż: tetracyclines, sulphonamides, phenothiazines, sustanzi ipogliċemiċi tat- tip sulphonylurea, dijuretiċi thiazide, griseofulvin u fluoroquinolones) jistgħu jżidu aktar din is - sensittività eċċessiva għad- dawl.
PhotoBarr PDT causes direct intracellular damage by initiating radical chain reactions that damage intracellular membranes and mitochondria.
Terapija fotodinamika, PhotoBarr, tagħmel ħsara fiċ- ċelluli billi tibda reazzjonijiet katina b’ radikali ħielsa li jattakkaw il- membrani intraċellulari u l- mitokondrija.
Tissue damage also results from ischaemia secondary to vasoconstriction, platelet activation and aggregation and clotting.
Ikun hemm ukoll ħsara fit- tessut minħabba iskemja sekondarja li tiġi wara tagħfis fl- arterji, attivazzjoni ta ’ plejtlets, aggregazzjoni u emboli.
Research in animals and in cell culture has suggested that many active substances could influence the effects of PDT, possible examples of which are described below.
Eżempji possibbli ta ’ sustanzi bħal dawn huma spjegati fil- paragrafu li jmiss.
There are no human data available to support or rebut these possibilities.
M’ hemmx stħarriġ fuq l- bniedem li jipprova jew immur kontra dawn l- possibiltajiet.
Compounds that quench active oxygen species or scavenge radicals, such as dimethyl sulphoxide, b-carotene, ethanol, formate and mannitol would be expected to decrease PDT activity.
Eżempji ta ’ sustanzi bħal dawn huma dimethyl sulphoxide, b- carotene, ethanol, formate u mannitol.
Preclinical data also suggest that tissue ischaemia, allopurinol, calcium channel blockers and some prostaglandin synthesis inhibitors could interfere with PhotoBarr PDT.
Informazzjoni ta ’ qabel l- użu kliniku tissuġerixxi li iskemja fit- tessut, allopurinol, imblokkaturi tal- kanali tal- kalċju u inibituri tal- produzzjoni ta ’ prostaglandins, jistgħu jinterferixxu ma ’ terapija fotodinamika ta ’ PhotoBarr.
Medicinal products that decrease clotting, vasoconstriction or platelet aggregation, e. g., thromboxane A2 inhibitors, could decrease the efficacy of PDT.
Prodotti mediċinalili jnaqqsu t- tgħaqqid tad- demm, it- tagħfis ta ’ vażi jew l- aggregazzjoni ta ’ plejtlets eż. inibituri ta ’ thromboxane A2, jistgħu jnaqqsu l- effikaċja ta ’ terapija fotodinamika.
Pregnancy There are no clinical data on exposed pregnancies available for porfimer sodium.
Tqala M’ hemmx tagħrif kliniku tal- effett ta ’ porfimer tas- sodju fuq it- tqala.
The potential risk for humans is unknown.
L- istħarriġ fuq l- annimali dwar t- tqala, l- iżvilupp tal- fetu, il- proċess tat- twelid, u l- iżvillup ta ’ wara, m’ huwiex biżżejjed (ara sezzjoni 5. 3).
Porfimer sodium should not be used during pregnancy, unless clearly necessary.
Ir- riskju li jista ’ jkun hemm meta jintuża fil- bniedem mhux magħruf.
Women of child-bearing potential should use effective contraception before, during and for at least 90 days after treatment.
Porfimer tas- sodju m’ għandux jintuża waqt it- tqala sakemm ma jkunx hemm triq oħra. Nisa li jistgħu jinqabdu tqal għandhom jużaw mezzi ta ’ kontraċezzjoni qabel, waqt u sa 90 jum wara t- trattament.
Lactation It is not known whether porfimer sodium is excreted into human breast milk.
7 Treddigħ Mhux magħruf jekk fil- bniedem, porfimer sodium jiġix eliminat fil- ħalib tas- sider jew le.
In rats, porfimer sodium passed into breast milk.
Fil- firien li jreddgħu nstab li porfimer sodium jgħaddi ġol- ħalib tas- sider.
Breast-feeding should be terminated prior to treatment.
Għaldaqstant, il- ħalib tas- sider għandu jitwaqqaf qabel it- trattament.
7 For the PDT procedure, sedation may be required, and consequently caution should be taken.
Il- proċedura ta ’ PDT tista ’ tirrikjedi l- użu tal- loppju u għalhekk wieħed irrid joqgħod attent.
Patients should not drive or use machines after the light treatment if they have been sedated for the procedure.
Il- pazjenti m’ għandhomx issuqu jew iħaddmu magni wara t- trattament bid- dawl jekk ikunu ġew mogħtija l- loppju għall- proċedura.
All patients who receive PhotoBarr will be photosensitive and must observe precautions to avoid sunlight and bright indoor light (see section 4.4).
Il- pazjenti kollha li ser jieħdu PhotoBarr ser ikunu sensittivi għad- dawl u għandhom josservaw prekawzjonijiet biex jevitaw id- dawl tax- xemx u d- dwal qawwi ta ’ ġewwa (ara sezzjoni 4. 4).
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.
Waqt studju farmakokinetiku, bit- tikketta tidher, kull wieħed minn 24 suġġett kellhom reazzjonijiet minħabba sensittività eċċessiva għad dawl.
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.
Dawn kienu kkaratterizzati b’ raxx eritematiku, u edema, u kienu jvarjaw fil- gravità minn ħfief għal moderati.
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.
Dawn ir- reazzjonijiet attakkaw l- aktar il- wiċċ, l - idejn, u partijiet tal- għonq, li huma kollha żoni suxxettibbli għal esposiżjoni aċċidentali għad- dawl tax- xemx.
These manifestations may be attributable to a pseudoporphyria state (temporary medicinal product-induced cutaneous porphyria).
Kien hemm rapportati wkoll effetti fuq il- ġilda li kienu anqas komuni bħal: żieda fir- rata ta ’ kemm jitwal ix- xagħar, bdil fil- lewn tal- ġilda, għoqod fil- ġilda, kif ukoll tikmix u fraġilità tal- ġilda.
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.
Dawn l- effetti setgħu ġew ikkaġunati minħabba stat ta ’ pseudoporfirja (porfirja fil- ġilda stimulata minn prodotti mediċinali).
20%) or the spontaneously reported incidence from commercial use of PhotoBarr (< 20%).
Il- frekwenza u n- natura ta ’ dawn r- reazzjonijiet minħabba sensittività eċċessiva għad- dawl, ma kienux bħal dawk rapportati fi studji kliniċi oħrajn li saru fuq pazjenti li għandhomkanċer (madwar 20%), jew bħal dawk rapportati waqt l- użu kummerċjali ta ’ PhotoBarr (< 20%).
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.
Jista ’ jkun li din il- frekwenza għolja kienet dovuta għal espożizzjoni twila għad- dawl fil- klinika tar- riċerka, jew inkella minħabba espożizzjoni aċċidentali għax- xemx meta l- pazjenti tħallew joħorġu.
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.
Fattur ieħor li seta kkontribwixxa għal din id- differenza huwa l- mod attiv li jgħixu l- individwi u l- fatt li kienu aktar b’ saħħithom u iżgħar mill- pazjenti b’ kanċer.
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.
It- trattament permezz ta 'terapija fotodinamika b’ PhotoBarr flimkien ma ’ omeprazole (PDT + OM) ġie mqabbel ma ’ grupp ittrattat b’ omeprazole biss (OM biss), waqt provi kliniċi kkontrollati fuq l- esofagu ta ’ Barrett (BO) flimkien ma ’ displasja qawwija (HGD).
In the PDT + OM group, 133 patients were treated.
Fil- grupp ta ’ PDT + OM, ġew ittrattati 133 pazjenti.
The most frequently reported adverse reactions were photosensitivity reactions (69%), oesophageal stenosis (40%), vomiting (32%), chest pain of non-cardiac origin (20%), pyrexia (20%), dysphagia (19%), constipation (13%), dehydration (12%) and nausea (11%).
L- aktar reazzjonijiet avversi rapportati kienu: sensittività eċċessiva għad- dawl (69%), stenożi fl- esofagu (40%), rimettar (32%), uġigħ fis- sider li mhuwiex tal- qalb (20%), deni (20%), disfaġja (19%), stitikezza (13%), deidratazzjoni (12%), u dardir (11%).
The majority of these reported adverse reactions were mild to moderate in intensity.
Fil- biċċa l- kbira, dawn ir- reazzjonijiet kienu minn ħfief sa moderati.
Adverse reactions reported are listed below in Table 5 by organ class and frequency.
F’ Tabella 5 hemm lista ta ’ reazzjonijiet avversi li huma klassifikati skond il- frekwenza u organu li effettwat.
Frequencies are defined as: very common (> 1/ 10); common (> 1/ 100 ,< 1/10); uncommon (> 1/1000 ,< 1/100).
Il- frekwenzi huma mfissra hekk: komuni ħafna (> 1/ 10); komuni (> 1/ 100, < 1/ 10); mhux komuni (> 1/ 1000, < 1/ 100).
Neoplasms benign,
Ġabra fil- qosor ta ’ reazzjonijiet avversi b’ porfimer sodium f’ pazjenti b’ HGD u BO Infezzjonijiet u infestazzjonijiet Mhux komuni:
Bronchitis, nail fungal infection, sinusitis, skin infection malignant and unspecified (incl cysts and polyps)
Bronkite, infezzjonijiet fungali fid- dwiefer, sinusite, infezzjonijiet fil- ġilda Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi) Mhux komuni:
Blood and lymphatic system disorders Uncommon:
Kanċer taċ- ċelluli bażali, lentigo Disturbi tad- demm u tas- sistema limfatika Mhux komuni:
Metabolism and nutrition disorders Very common:
Lewkoċitożi Disturbi fil- metaboliżmu u n- nutrizzjoniKomuni ħafna:
Dehydration Common:
Komuni:
Uncommon:
Ipokalimja
Appetite decreased, electrolyte imbalance Hypokalaemia
Deidratazzjoni
Psychiatric disorders Common:
8 Disturbi psikjatriċi Komuni:
Anxiety, insomnia Restlessness
Ansjetà, nuqqas ta ’ rqad
Eye disorders
Irrekwitezza Disturbi fis- sistema nervuża Komuni:
Headache, paraesthesia, dysgeusia Dizziness, hypoaesthesia, tremor
Uġigħ ta ’ ras, paresteżja, disgewsja
Eye irritation, eye oedema
Sturdament, ipoesteżija, rogħda Disturbi fl- għajnejn Mhux komuni:
8 Ear and labyrinth disorders Uncommon:
Irritazzjoni fil- għajnejn, edema fl- għajnejn Disturbi fil- widnejn u sistema labrintika Mhux komuni:
Cardiac disorders
Truxija, tinnite, tinnite aggravata Disturbi fil- qalb Komuni:
Deafness, tinnitus, tinnitus aggravated
Takikardja, uġigħ fis- sider
Vascular disorders Uncommon:
Angina pectoris, fibrillazzjoni atrijali, tħabbit irregolari fl- arterji, skonfort fis- sider Disturbi vaskulari Mhux komuni:
Hypertension, haemorrhage, hot flushes, hypotension, orthostatic hypotension
Pressjoni għolja, emorraġija, fwawar, pressjoni baxxa, pressjoni baxxa meta tqum bil- wieqfa Disturbi respiratorji, toraċiċi u medjastinali
Respiratory, thoracic and mediastinal disorders Common:
Komuni:
Choking, dyspnoea exertional, haemoptysis, hypoxia, nasal congestion, pneumonia aspiration, productive cough, respiratory depression, respiratory tract congestion, wheezing
Effużjoni plewrali, farinġite, atelektażi, qtugħ ta ’ nifs Tifga, qtugħ ta ’ nifs meta tagħmel sforz, emoptisi, ipoksja, konġestjoni fl - imnieħer, infjammazjoni tal- pulmun minħabba aspirazzjoni, sola misjura, dipressjoni respiratorja, konġestjoni fl- apparat tas- sistema respiratorja, tħarħir
Gastrointestinal disorders Very common:
Disturbi gastrointestinali Komuni ħafna:
Oesophageal stenosis acquired, vomiting, dysphagia, constipation, nausea Common:
Stenożi akkwistata tal- esofagu, rimettar, disfaġja, stitikezza, dardir Komuni:
Hiccups, odynophagia, diarrhoea, dyspepsia, oesophageal ulcer, abdominal pain upper, abdominal pain, haematemesis, oesophageal pain, eructation, melaena (haematocheznia), oesophageal disorder, regurgitation of food, abdominal rigidity, oesophageal spasm, oesophagitis.
sulluzzu, odinofaġja, dijarea, dispepsja, ulċera fl- esofagu, uġigħ fin naħa ta ’ fuq tal- addome, uġigħ fl- addome, ematemesi, uġigħ fl- esofagu, tifwiq, melaena (ematoċeznija), disturb fl- esofagu, rigurġitazzjoni tal- ikel, spażmu fl- esofagu, esofaġite.
Loose stools, oesophagitis ulcerative, abdominal discomfort, abdominal distension, abdominal pain lower, acquired pylori stenosis, chapped lips, colitis, flatulence, gastritis, gastrointestinal haemorrhage, halitosis, oesophageal haemorrhage, oesophageal perforation.
Purgar maħlul, ulċeri fl- esofagu, uġigħ ħafif fl- addome, distenzzjoni addominali, uġigħ fin- naħa t ’ isfel tal- addome, stenożi pajlori akkwiżiti, xufftejn maqsuma, kolite, uġigħ ta ’ gass, gastrite, emorraġija fl- istonku u l - imsaren, halitosis, emorraġija fl- esofagu, esofaġite ulċerativa, skumdita addominali, distensjoni addominali, toqob fl- esofagu.
Photosensitivity reaction Common:
Sensittività eċċessiva għad- dawl Komuni:
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
Ħakk, raxx, ġilda fraġili, bidliet fil- lewn tal- ġilda, ulċeri tal- ġilda, dermatite, tqaxxir tal- ġilda, ġilda xotta, milia, raxx makulo- papulari, raxx papulari, ċikatriċi, iperpigmentazzjoni tal- ġilda, feriti fil- ġilda, għoqod fil- ġilda, urtikarja
Cold sweat, dermatitis, hair growth abnormal, increased tendency to bruise, keloid scar, night sweats, photosensitive rash, rash macular, rash scaly, scab, scar pain, vitiligo.
Għaraq kiesaħ, dermatite, xagħar jikber b ’ mod mhux normali, tendenza li titbenġel malajr, ċikatriċi kelojd, għaraq bil- lejl, raxx mid- dawl, raxx makulari, raxx bil- qxur, skorċa ta ’ qxur niexef, uġigh fil- ċikatriċi, vitiligo.
Back pain, pain in the limb Joint contracture, joint range of motion decreased, musculoskeletal chest pain, plantar fascitis
Uġigħ fid- dahar, uġigħ fir- riġlejn Ġbid fil- ġogi, tnaqqis fil- movimenti tal- ġogi, uġigħ fil- muskoli u għadam tas- sider, plantar faxxite
Uncommon:
Disturbi fil- kliewi u tas- sistema urinarja Mhux komuni:
Reproductive system and breast disorders Uncommon:
Tiżmim tal- awrina Disturbi fis- sistema riproduttiva u fis- sider Mhux komuni:
Congenital, and familial and genetic disorders Uncommon:
9 Disturbi konġenitali u ġenetiċi/ familjali Mhux komuni:
General disorders
Deni Komuni:
Pigmented naevus and administration site conditions
Rogħda ta ’ bard, għajja
Rigors, fatigue Feeling hot, injection site erythema, lethargy, malaise, oedema peripheral, pain, pitting oedema, temperature intolerance, weakness
Sħanat, eritema fil- post tal- injezzjoni, ħass ħażin, edema periferali, uġigħ, edema bil- ħofor, intolleranza tas- sħana, dgħjufija Stħarriġ Komuni: