qanastek/EMEA-V3 huggingface dataset:
A second course of treatment may be given at the discretion of the treating physician in patients where additional tumour necrosis and removal is deemed appropriate, with a recommended minimum interval of 4 weeks between treatments.
It- tieni kors ta 'kura jista ’ jingħata skond il- fehma tat- tabib li jkun qed jikkura lill- pazjenti fejn ikun meħtieġ ukoll nekrożi u tneħħija ta ’ tumur, b’ intervall minimu rakkomandat ta ’ 4 ġimgħat bejn l- interventi.
Use in children - There is no relevant indication for use of Foscan in children or adolescents.
Użu fi tfal - M’ hemmx indikazzjoni rilevanti sabiex Foscan jingħata lit- tfal jew l- adoloxxenti.
 Hypersensitivity to the active substance or to any of the excipients.  Porphyria or other diseases exacerbated by light.  Hypersensitivity to porphyrins.  Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site.  A planned surgical procedure within the next 30 days.  Coexisting ophthalmic disease likely to require slit-lamp examination within the next 30 days.  Existing therapy with a photosensitizing agent.
 Sensittività eċċessiva għas- sustana attiva jew għal xi sustanzi mhux attivi  Porfirja jew mard ieħor li jmur għall- agħar bid- dawl  Sensittività eċċessiva għal porphyrins  Tumuri li huma magħrufa li qed jieklu f’ vina/ arterja prinċipali li tinsab fis- sit ta ’ illuminazzjoni jew qribha  Jekk intervent kirurġiku jkun ippjanat fi żmien 30 jum  Jekk ikun hemm mard tal- għajnejn ko- eżistenti li aktarx ikun jeħtieġ eżami b’ dawl qawwi fi żmien 30 jum  Jekk qed tingħata terapija permezz ta ’ dawl qawwi
Special care must be taken to prevent extravasation at the injection site.
Għandha tingħata attenzjoni speċjali sabiex tiġi evitata l- estravażjoni fis- sit ta ’ l- injezzjoni.
If extravasation occurs, protect the area from light for at least 3 months.
Jekk isseħħ l- estravażjoni, ipproteġi din il- parti mid- dawl għal mill- anqas tliet xhur.
There is no known benefit from injecting the extravasation site with another substance.
M’ hemm l- ebda benefiċċju magħruf mill- injezzjoni ta ’ xi sustanza oħra fis- sit fejn seħħet l- estravażjoni.
Some pulse oximeters may produce light of a wavelength close to that used for the photoactivation of Foscan.
Xi ossimetri tal- polz jistgħu jipproduċu dawl ta ’ tul ta 'wavelength li hija qrib ta ’ dik li tintuża għall- fotoattivazzjoni ta ’ Foscan.
Oximeters must be repositioned at least every 10-15 minutes to avoid the risk of local skin burns.
Il- pożizzjoni ta ’ l- ossimetri għandha tinbidel mill- anqas kull 10- 15- il minuta sabiex jiġi evitat ir- riskju ta ’ ħruq lokali tal- ġilda.
For 6 months following Foscan treatment avoid prolonged direct sunlight exposure of the injection site arm.
Għal 6 xhur wara l- għoti tat- terapija ta ’ Foscan evita l- espożizzjoni prolongata diretta tas- sit ta ’ l- injezzjoni għax- xemx.
As a precautionary measure, if prolonged outdoor activity is planned, the injection arm should be protected by wearing a long sleeved, coloured shirt.
Bħala miżura ta ’ prekawzjoni, jekk xi attività fuq barra hija ppjanata għal tul ta ’ ħin, id- driegħ injettat għandu jiġi protett billi tintlibes qmis b’ komma twila kkulurita.
Unplanned or emergency surgical procedures where Foscan has been administered within the previous 30 days must be undertaken only if absolutely necessary and the potential benefits outweigh the risk to the patient.
Fil- każ li Foscan ikun ingħata matul l- aħħar 30 ġurnata, interventi kirurġiċi mhux ippjanati jew ta ’ emerġenza, għandhom isiru biss jekk ikunu assolutament meħtieġa u fejn il- benefiċċji potenzjali jiżbqu r- riskju għall- pazjent.
All precautions must be taken to avoid direct illumination of the patient with surgical lamps during these procedures.
Għandhom jittieħdu l- prekawzjonijiet kollha biex tiġi evitata l- illuminazzjoni diretta tal- pazjenti b’ lampi tal- kirurġija matul dawn il- proċeduri.
All patients who receive Foscan will become temporarily photosensitive.
Il- pazjenti kollha li jingħataw Foscan isiru temporanjament fotosensittivi.
Precautions must be taken to avoid exposure of skin and eyes to direct sunlight or bright indoor light during the first 15 days after injection.
Għandhom jittieħdu l- prekawzjonijiet biex tkun evitata l- espożizzjoni tal- ġilda u ta ’ l- għajnejn għad- dawl dirett tax- xemx jew għal dawl qawwi ta ’ ġewwa, matul l- ewwel 15- il jum wara l- injezzjoni.
Skin photosensitivity reactions are caused by visible light; therefore ultraviolet sunscreens provide no protection.
Reazzjonijiet fotosensittivi tal- ġilda huma kkaġunati b' dawl viżibbli, u għalhekk prodotti li jilqgħu mir- raġġi ta ’ l- ultravjola ma jipprovdu l- ebda protezzjoni.
It is important that patients are re-introduced to normal light gradually.
Hu importanti li l- pazjenti jerġgħu jiġu esposti għad- dawl normali b’ mod gradwali.
Clinicians must counsel patients to observe the following precautions that are provided in the Package Leaflet.
It- tobba għandhom jagħtu parir lill- pazjenti biex josservaw il- prekawzjonijiet segwenti li huma provduti fil- Fuljett ta ’ Tagħrif:
Time after
Ħin wara
What should I do to prevent burns?
X’ għandi nagħmel biex nevita l- ħruq tal- ġilda?
Foscan Injection Day 1 (0-24 hours)
l- Injezzjoni ta ’ Foscan L- 1 Ġurnata (0- 24 siegħa)
Stay indoors in a darkened room.
Ibqa ’ ġewwa f’ kamra mudlama.
Keep the curtains drawn and use light bulbs of 60W or less.
Żomm il- purtieri magħluqin u uża bozoz ta ’ 60 W jew anqas.
Avoid exposure to direct sunlight.
Evita l- espożizzjoni diretta għad- dawl tax- xemx.
Days 2-7
2- 7 Ġurnata
You can gradually return to normal indoor lighting.
Int tista ’ ftit ftit tirritorna għad- dawl normali fuq ġewwa.
Remember to avoid direct sunlight coming through the window or direct light from household appliances such as reading lamps.
Tista ’ tara t- televiżjoni.
You may watch television.
Tista ’ toħroġ mid- dar wara li tinżel ix- xemx.
The type of clothes you must wear are:
Jekk ikun assolutament meħtieġ li toħroġ barra matul il- ħin tad- dawl tax- xemx, għandek toqgħod attent li tgħatti l- ġilda tiegħek kollha inklużi wiċċek u idejk u ilbes nuċċali skur.
Scarf: for head and neck.
It- tip ta ’ ħwejjeġ li għandek tilbes jinkludu:
Long sleeved top: for upper body/ arms.
Kappell bil- faldi wiesa: għar- ras, għonq, imnieħer u widnejn Xalla: għar- ras u għonq Nuċċali tax- xemx b’ pannelli tal- ġemb: għall- għajnejn u l- ġilda ta ’ madwar l- għajnejn Flokk tal- komma twila: għall- parti ta ’ fuq tal- ġisem/ dirgħajn Qalziet twil: għall- parti t’ isfel tal- ġisem/ riġlejn Ingwanti: għall- idejn, polz u swaba Kalzetti: għas- saqajn u l- għekiesi Żarbun magħluq: għas- saqajn Tilbisx ħwejjeġ ħfief ħafna, għaliex ma jħarsukx mid- dawl qawwi.
Long trousers: for lower body/ legs.
Ilbes ħwejjeġ skuri, minsuġin tajjeb.
Closed shoes: for feet.
Jekk tesponi ruħek għad- dawl bi żball, tista ’ tħoss il- ġilda tniggeż jew taħraq.
Do not wear very thin clothing because it will not protect you from strong light.
Oħroġ mid- dawl immedjatament.
If you expose yourself to light by mistake, you may get a prickly or burning feeling on the skin.
Għajnejk jistgħu jkunu sensittivi ħafna għad- dawl qawwi matul din il- ġimgħa.
Your eyes may be very sensitive to bright lights during this week.
Jista ’ jkollok uġigħ f’ għajnejk jew uġigħ ta ’ ras meta tixgħel id- dawl.
If you have this problem, wear dark glasses.
Jekk ikollok din il- problema, ilbes nuċċali skur.
Days 8-14
8- 14 Ġurnata
You can now begin to go outside during daylight hours.
Issa tista ’ tibda toħroġ barra matul il- ħin tad- dawl tax- xemx.
Stay in shaded areas or go out when it is cloudy.
Ibqa ’ f’ żoni dellin jew oħroġ meta jkun imsaħħab.
Continue to wear dark, closely woven clothing.
Ibqa ’ ilbes ħwejjeġ skuri u li huma minsuġin tajjeb.
Start on Day 8 with 10-15 minutes outdoors.
Mat- 8 ġurnata ibda oħroġ barra għal 10- 15- il minuta.
If you do not see any skin redness in the next 24 hours, you can gradually increase your time outdoors during the week.
Jekk ma tara l- ebda ħmura sa l- 24 siegħa li jmiss, tista ’ gradwalment iżżid il- ħin tiegħek barra matul il- ġimgħa.
Avoid direct sunlight or strong indoor lighting.
Evita d- dawl tax- xemx dirett jew dawl qawwi ta ’ ġewwa.
Stay in the shade.
Ibqa ’ fid- dell.
Day 15 onward
15- il Ġurnata `l quddiem
Your sensitivity to light is gradually getting back to normal.
Is- sensittività tiegħek għad- dawl qegħda tirritorna lura għan- normal.
You must test this carefully by exposing the back of your hand to the sun for 5 minutes.
Għandek tivverifika dan b’ attenzjoni billi tesponi n- naħa ta ’ wara ta ’ idejk għax- xemx għal 5 minuti.
Wait 24 hours to see if there is any redness.
Agħti 24 siegħa ċans biex tara jekk hemmx xi ħmura.
If there is redness, you should avoid direct sunlight for another 24 hours.
Jekk hemm il- ħmura, għandek tevita d- dawl tax- xemx dirett għal 24 siegħa oħra.
You can then repeat the test.
Wara, tista ’ tirrepeti din il- prova.
If there is no redness, you can gradually increase your exposure to sunlight day by day.
Jekk m’ hemmx ħmura, tista ’ bil- mod tibda żżid l- espożizzjoni tiegħek għax- xemx ġurnata b’ ġurnata.
Do not stay in the sunlight for more than 15 minutes the first time.
Għall- ewwel darba, tibqax aktar minn 15- il minuta fid- dawl tax- xemx.
Most people will be able to go back to their normal routine by Day 22.
Il- parti l- kbira tan- nies jerġgħu lura għar- rutina normali wara madwar 22 ġurnata.
On the first day after the skin test, you can stay in direct sunlight for 15 minutes.
Fl- ewwel ġurnata wara l- prova fuq il- ġilda, tista ’ tibqa fid- dawl tax- xemx dirett għal 15- il minuta.
You can increase your exposure by another 15 minutes each day i. e. second day 30 minutes, third day 45 minutes, fourth day 60 minutes and so on.
Tista ’ żżid l- espożizzjoni tiegħek bi 15- il minuta kuljum, i. e. it- tieni ġurnata 30 minuta, it- tielet ġurnata 45 minuta, ir- raba ’ ġurnata 60 minuta, u tibqa ’ sejjer hekk.
If at any time you notice a prickly or burning feeling or see skin reddening after exposure to sun, wait until this disappears before exposing your skin to light for this length of time again.
Jekk fi kwalunkwe mument tinnota xi tingiż jew ħruq jew tara ħmura fuq il- ġilda wara l- espożizzjoni għax- xemx, agħti ċans li din titlaq qabel ma terġa tesponi l- ġilda tiegħek għad- dawl għal dan it- tul ta ’ ħin għal darba oħra.
For 30 days following Foscan treatment, avoid eye tests that use bright lights.
Għal 30 ġurnata wara l- kura b’ Foscan evita li tagħmel testijiet ta ’ l- għajnejn li jużaw dwal qawwi.
For 3 months following Foscan treatment, avoid UV tanning beds.
Għal 3 xhur wara l- kura b 'Foscan, evita li tixxemmex b’ soddod tal- UV.
Do not sunbathe.
Tixxemmix.
For 6 months following Foscan treatment, care should be taken to avoid direct prolonged sunlight exposure of the arm used for Foscan injection.
Għal 6 xhur wara l- għoti tat- terapija ta ’ Foscan evita l- espożizzjoni prolongata diretta tas- sit ta ’ l- injezzjoni għax- xemx.
As a precautionary measure, if prolonged outdoor activity is planned, the injection arm should be protected by wearing a long sleeved, coloured shirt.
Bħala miżura ta ’ prekawzjoni, jekk xi 4 attività fuq barra hija ppjanata għal tul ta ’ ħin, id- driegħ injettat għandu jiġi protett billi tintlibes qmis b’ komma twila kkulurita.
4 This product contains 48 vol% ethanol (alcohol), i. e up to 4.2 g per dose, equivalent to 84 ml of beer, 35 ml wine per dose.
Dan il- prodott fih 48 vol% ta ’ ethanol (alkoħol), i. e sa 4, 2 g f’ kull doża, li hija ekwivalenti għal 84 ml ta ’ birra, 35 ml inbid għal kull doża.
Harmful for those suffering from alcoholism.
Dan hu perikoluż għal dawk li jbatu mill- alkoħoliżmu.
The amount of alcohol in this product may alter the effects of other medicines.
Dan għandu jiġi kkunsidrat f ’ nisa tqal jew li qed ireddgħu, tfal, u dawk il- gruppi li jinsabu f’ riskju bħal pazjenti b’ mard tal- fwied jew bl- epilessija.
There is potential for exacerbation of skin photosensitivity if temoporfin is used with other photosensitising active substances.
Hemm il- possibbilità li l- fotosensittività tal- ġilda tmur għall- agħar jekk temoporfin jintuża ma ’ sustanzi oħra fotosensitizzanti attivi.
Such a reaction has been reported with topical 5-fluorouracil.
Reazzjoni bħal din kienet irrapportata flimkien ma ’ 5- fluorouracil topiku.
No other drug interactions have been observed.
Ma kienu osservati l- ebda effetti ma 'mediċini oħrajn.
An in vitro study with human liver tissue has shown no potential for drug interaction through inhibition of cytochrome P-450 enzymes by temoporfin.
Studju in vitro fuq it- tessut tal- fwied tal- bniedem ma wera l- ebda potenzjal għal interazzjoni tal- mediċina permezz ta ’ l- impediment ta ’ l- enżimi ta 'ċitrokroma P- 450 b' temoporfin.
4.6 Pregnancy and lactation
Tqala u Treddigħ 4. 6
There are no data from the use of temoporfin in pregnant women.
M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ temoporfin waqt it- tqala.
Animal studies are insufficient with respect to effects on embryonal/ foetal development (see section 5.3).
Studji fuq bhejjem m’ humiex biżżejjed fir- rigward ta 'effetti dwar l- iżvilupp ta ’ l- embriju/ fetu (ara sezzjoni 5. 3).
The potential risk for humans is unknown.
Ir- riskju li jista 'jkun hemm fuq in- nies, mhux magħruf.
Temoporfin should not be used during pregnancy unless clearly necessary.
Temoporfin m’ għandux jintuża waqt it- tqala jekk m’ hemmx bżonn ċar.
Animal studies suggest a toxic effect in early pregnancy (see section 5.3).
Studji fuq bhejjem jissuġġerixxu effett tossiku fil- bidu tat- tqala (ara sezzjoni 5. 3).
Therefore, pregnancy must be avoided for 3 months after treatment with temoporfin.
Għalhekk, għandha tiġi evitata t- tqala sa 3 xhur wara l- kura b 'temoporfin.
It is not known if temoporfin is excreted in human milk.
Mhux magħruf jekk temoporfin jiġiex eliminat fil- ħalib ta ’ l- omm.
Women receiving Foscan must not breast feed for at least one month following injection.
Nisa li qed jingħataw Foscan m’ għandhomx ireddgħu sa mill- anqas xahar wara l- injezzjoni.
4.7 Effects on ability to drive and use machines
Effetti fuq il- ħila biex issuq u tħaddem magni 4. 7
The amount of alcohol in this product may impair your ability to drive or use machines.
L- ammont ta ’ alkoħol f’ dan il- prodott jista ’ jimpedixxi l- ħila tiegħek li ssuq jew tħaddem inġenji.
On the basis of the pharmacodynamic profile, temoporfin is presumed to be safe or unlikely to produce an effect.
Abbażi tal- profil farmakodinamiku, wieħed jista ’ jassumi li temoporfin huwa sikur jew mhux mistenni li jipproduċi xi effett.
To avoid photosensitivity problems, it is advised not to drive during the first 15 days after injection, and to use machines only if it is practical to do so under subdued lighting conditions according to the recommended lighting precautions (see section 4.4).
Biex tevita problemi ta ’ fotosensittività, il- parir hu li ma ssuqx matul l- ewwel 15- il ġurnata wara l- injezzjoni, u li tuża magni biss jekk hu prattiku li tagħmel hekk taħt kondizzjonijiet ta ’ dawl baxx skond il- prekawzjonijiet rakkomandati dwar id- dawl (ara sezzjoni 4. 4).
Driving and use of machines may resume under normal lighting or daylight conditions once photosensitivity has been shown to have subsided.
Is- sewqan u l- użu ta ’ magni jista ’ jkompli taħt kondizzjonijiet ta ’ dawl normali jew tad- dawl tax- xemx hekk kif ikun jidher li l- fotosensittività tkun għaddiet.
All patients who receive Foscan will become temporarily photosensitive and must be instructed to observe precautions to avoid sunlight and bright indoor light.
Il- pazjenti kollha li jingħataw Foscan isiru temporanjament fotosensittivi u għandhom jingħataw struzzjoni biex jieħdu l- prekawazzjonijiet biex jevitaw id- dawl tax- xemx u dawl qawwi ta ’ ġewwa.
Most toxicities associated with this therapy are local effects seen in the region of illumination and occasionally in surrounding tissues.
L- aktar effetti tossiċi marbuta ma ’ din it- terapija huma effetti lokali li dehru fil- parti ta ’ l - illuminazzjoni u kull tant żmien fit- tessuti tal- madwar.
The local adverse reactions are characteristic of an acute tissue inflammatory response induced by photoactivation.
Ir- reazzjonijiet lokali avversi huma karatteristiċi ta ’ effett akut ta ’ infjammazjoni tat- tessut bħala riżultat tal- fotoattivazzjoni.
The frequency listed below is defined using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10).
Il- frekwenza elenkata hawn isfel hija skond il- konvenzjoni li ġejja: komuni ħafna (≥ 1/ 10); komuni (≥ 1/ 100, < 1/ 10).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
L- effetti li huma l- aktar serji mniżżla qabel dawk anqas serji.
5 Infections and infestations Common effects: localised infection.
5 Disturbi tad- demm u tas- sistema limfatika Effetti komuni: anemija
Gastrointestinal disorders Very common effects: constipation.
Disturbi gastro- intestinali Effetti komuni ħafna: stitikezza.
Common effects: vomiting, mouth ulceration, swallowing difficult.
Effetti komuni: remettar, ulċeri fil- ħalq, diffikultà biex tibla ’
Skin and subcutaneous tissue disorders Common effects: blisters, erythema, burn, skin hyperpigmentation, photosensitivity reaction, sunburn, skin necrosis.
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Effetti komuni: infafet, ġilda fl- aħmar, ħruq, iperpigmentazzjoni tal- ġilda, reazzjoni fotosensittiva, ħruq tax- xemx, nekrosi tal- ġilda.
General disorders and administration site conditions Very common effects: injection site pain.
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata Effetti komuni ħafna: uġigħ fis- sit ta ’ l- injezzjoni.
This pain is transient and can be reduced by slowing the injection rate.
Dan l- uġigħ ma jdumx ħafna u jista ’ jitnaqqas billi l- injezzjoni tingħata bil- mod.
Common effects: fever, nausea, injection site reaction, burning sensation, giddiness.
Effetti komuni: deni, dardir, reazzjoni fis- sit ta ’ l- injezzjoni, sensazzjoni ta ’ ħruq, sturdament
Surgical and medical procedures Very common effects: pain, haemorrhage, pain in face, scar, mouth necrosis, dysphagia, face oedema.
Proċeduri kirurġiċi u mediċi Effetti komuni ħafna: uġigħ, emorraġija, uġigħ fil- wiċċ, marki, nekrożi fil- ħalq, disfaġja, edema fil - wiċċ.
The pain may require the use of NSAIDs or opiate analgesics for a short time following treatment.
L- uġigħ jista ’ jkun jeħtieġ l- użu ta ’ NSAIDs jew analġeżiċi opiate għal perijodu qasir wara l - kura.
Common effects: oedema, trismus.
Effetti komuni: edema, triżmu (ma tistax tiftaħ ħalqek).
In the event of an overdose, laser treatment would result in deeper tumour necrosis than would be expected with the recommended dose.
Fil- każ ta ’ doża eċċessiva, kura bil- laser tirriżulta f’ nekrożi aktar profonda tat- tumur milli jkun mistenni bid- doża rakkomandata.
Illumination of the tumour should only be carried out if the potential benefit justifies the potential risk of excessive necrosis.
Illuminazzjoni tat- tumur għandha ssir biss jekk il- benefiċċju potenzjali jiġġustifika r- riskju potenzjali ta ’ nekrożi eċċessiva.
If the tumour is not illuminated, a period of at least 4 weeks between overdose and re-administration of Foscan must be allowed.
Jekk it- tumur ma jiġix illuminat, għandu jitħalla perijodu ta ’ mill- anqas 4 ġimgħat qabel terġa ’ tieħu Foscan.
The adverse reactions associated with overdose would be expected to be limited to photosensitivity reactions.
Huwa mistenni li r- reazzjonijiet avversi assoċjati ma ’ doża eċċessiva ta ’ Foscan ikunu marbuta ma ’ reazzjonijiet ta ’ fotosensittività.
Exposure to ambient light after overdose carries an increased risk of photosensitivity reactions.
Espożizzjoni għal dawl naturali wara doża eċċessiva iżżid r- riskju ta ’ reazzjonijiet fotosensittivi.
Published clinical research has shown that the duration and intensity of photosensitivity at the recommended dose of 0.15 mg/ kg were reduced by one third relative to a dose of 0.3 mg/ kg.
Riċerka klinika ppublikata wriet li t- tul u l- intensità ta 'fotosensittività meta ngħatat doża rakkomandata ta ’ 0. 15 mg/ kg tnaqqsu b’ terz meta mqabbla ma ’ doża ta ’ 0. 3 mg/ kg.
Animal studies have shown some haematological and blood chemistry changes (decreased platelets, erythrocytes and haemoglobin, increased neutrophils, fibrinogen, bilirubin, triglyceride and cholesterol).
Studji fuq bhejjem urew xi bidliet ematoloġiċi u fil- kimika tad- demm (tnaqqis fl- għadd tal- plejtlets, tal- eritroċiti u tal- emoglobina u żjieda ta ’ newtrofili, ta ’ fibrinoġen, ta ’ bilirubin, ta ’ trigliċeridi u ta ’ kolesterol).
Strict observance of the reduced light regime is required.
Hemm bżonn ta ’ osservazzjoni stretta tal- programm ta ’ dawl imnaqqas.
A skin photosensitivity test must be carried out before the patient returns to normal light conditions.
Irid isir test ta 'fotosensittività tal- ġilda qabel ma ’ l- pazjent jirritorna għall- kondizzjonijiet ta' dawl normali.
No specific systemic symptoms are known to be associated with overdose.
M’ huma magħrufa l- ebda sintomi sistemiċi speċifiċi marbuta ma ’ doża eċċessiva.
Treatment should be supportive.
Il- kura għandha tkun ta ’ appoġġ.
Limited information is available on the effects of overexposure to laser light during treatment.
Informazzjoni ristretta hija disponibbli dwar l- effetti ta ’ espożizzjoni eċċessiva għal dawl tal- laser matul il- kura.
Increased damage to tissue was noted.
Ġiet osservata ħsara akbar fit- tessut.
5.1 Pharmacodynamic properties
Tagħrif farmakodinamiku 5. 1
Pharmacotherapeutic group:
Grupp farmakodinamiku:
L01XD05.
Mediċina antineoplastika u immunomodulanti, Kodiċi ATC hu L01XD05.
Temoporfin is a photosensitising agent used in the photodynamic therapy of tumours.
Temoporfin hija mediċina fotosensitizzanti li tintuża fit- terapija fotodinamika ta ’ tumuri.
6 The pharmacological activity is initiated by photoactivation of temoporfin with non-thermal light at 652nm following intravenous administration.
L- attività farmakoloġika tinbeda b' fotoattivazzjoni ta ’ temoporfin b’ dawl mhux termali ta '652 nm wara li jingħata ġol- vina.
The therapeutic effect is mediated through the generation of highly reactive oxygen species, a process dependent on the intracellular interaction of temoporfin with light and oxygen.
L- effett terapewitiku jinkiseb permezz tal- ġenerazzjoni ta ’ speċi ta ’ ossiġnu mill- aktar reattiv, proċess li jiddependi fuq l- interazzjoni intraċellulari ta ’ temoporfin ma 'dawl u ossiġnu.
In a clinical trial of 147 patients with advanced head and neck squamous cell carcinoma, tumour response, defined as a reduction of a minimum of 50% of the tumour mass for a minimum of four weeks, was observed in 25% after a single treatment.
6 Fi prova klinika li saret fuq 147 pazjent b’ karċinoma avvanzata taċ- ċelluli skwamużi fir- ras u fl- għonq, riżultat pożittiv fuq it- tumur, definit bħala tnaqqis ta ’ minimu ta ’ 50% tal- massa tat- tumur għallinqas għal erba ’ ġimgħat, kien osservat f’ 25% tal- pazjenti wara trattament wieħed.
A WHO local complete response was observed in 14% of patients.
Effett lokali komplut skond il- WHO ġie osservat f’ 14% tal- pazjenti.
Tumour responses are enhanced in patients with fully illuminated lesions of 10mm or less in depth.
Ir- riżultati fuq it- tumur kienu mtejjba f’ pazjenti b’ feriti lluminati kompletament fi profondità ta ’ 10 mm jew anqas.
The median observed duration of tumour response for all patients was 57 days for overall response and 84 days for complete response.
Iż- żmien medju ta ’ kemm dam l- effett fuq it- tumur għall- pazjenti kollha kien ta ’ 57 jum għar- riżultat ġenerali u 84 jum għar- riżultat komplut.
Thirty-seven patients received at least 2 treatments with Foscan.
Sebgħa u tletin pazjent ingħataw mill- anqas 2 trattamenti b’ Foscan.
Ten patients achieved a tumour response due to re-treatment.
Għaxar pazjenti kisbu riżultati pożittivi fuq it- tumur permezz ta 'kura repetuta.
Of these, 6 had a complete local response according to WHO criteria.
Minn dawn, 6 kellhom riżultat lokali komplut skond il- kriterji tal- WHO.
5.2 Pharmacokinetic properties
Tagħrif farmakokinetiku 5. 2
Temoporfin is a low clearance substance with a terminal plasma half-life of 65 hours in patients.
Temoporfin huwa sustanza li għandu r- rata ta 'tneħħija baxxa, b’ half- life terminali fil- plażma ta ’ 65 siegħa fil- pazjenti.
Peak plasma levels occur at 2-4 hours post-injection thereafter plasma levels decline in a bi-exponential manner.
L- ogħla livelli fil- plażma jintlaħqu wara 2- 4 sigħat wara l- injezzjoni, u għalhekk il - livelli fil- plażma jonqsu b’ mod bi- esponenzjali.
An extensive volume of distribution is observed that is intermediate between total and extracellular body water.
Kien osservat volum ta ’ distribuzzjoni estensiv li hu intermedju bejn l- ilma totali u ilma extraċellulari tal- ġisem.
Temoporfin does not concentrate in the tissues.
Temoporfin ma jakkumulax fit- tessuti.
Plasma protein binding is at 85-87%.
Ir - rabta ma 'proteini tal- plażma hi ta ’ 85- 87%.
Temoporfin is bound to plasma lipoproteins and high density proteins such as albumin in the blood.
Temoporfin jingħaqad ma 'lipoproteini tal- plażma u ma ’ proteini ta ’ densità għolja bħal albumina fid- demm.
By 15 days post-infusion, temoporfin plasma concentration has declined to background such that patients are generally able to begin a gradual return to normal outdoor lighting conditions.
Sa 15- il jum wara l- infużjoni, il- konċentrazzjoni ta 'temoporfin fil- plażma naqset għal- livelli baxxi b’ tali mod li l- pazjenti ġeneralment ikunu jistgħu jerġgħu jirritornaw gradwalment għal kondizzjonijiet normali tad- dawl ta ’ barra.
Limited data are available on the elimination of temoporfin in humans.
Hemm informazzjoni ristretta disponibbli dwar l- eliminazzjoni ta ’ temoporfin fil- bniedem.
Animal data show temoporfin is exclusively eliminated by the liver into the bile and excreted in the faeces.
Informazzjoni miksuba mill- bhejjem turi li temoporfin huwa eliminat esklussivament mill- fwied fil- bile u jitneħħa ma ’ l- ippurgar.
Two major metabolites of temoporfin are eliminated into the bile.
Żewġ metaboli ewlenin ta 'temoporfin huma eliminati fil- bile.
There is no enterohepatic recirculation of these metabolites.
Dawn il- metaboli ma jiġux iċċirkolati mill- ġdid mill- fwied.
Both these metabolites show conjugated character.
Dawn iż- żewġ metaboli juru karatteristiċi kkonjugati.
No metabolites are seen in the systemic circulation.
L- ebda metabolu ma jidher fiċ- ċirkolazzjoni sistematika.
5.3 Preclinical safety data
Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina 5. 3
In repeated dose toxicity studies in rats and dogs, the main undesirable effects of temoporfin were phototoxicity and adverse injection site reactions.
Fi studji dwar it- tossiċita, fejn ingħataw dożi repetuti lill- firien u lill- klieb, l- effetti mhux mixtieqa prinċipali ta ’ temoporfin kienu l- fototossiċità u reazzjonijiet avversi fis- sit ta ’ l- injezzjoni.
Local irritancy of Foscan solution for injection after intravenous administration occurred with all doses.
Irritazzjoni lokali għas- soluzzjoni għall- injezzjoni ta ’ Foscan wara li ngħatat ġol- vina, kienet rapportata mad- dożi kollha.
High rates of administration caused death in dogs and rabbits.
Meta ngħata b’ rati għolja wassal għall- mewt ta ’ klieb u fniek.
No other signs of toxicity were found, however, in dogs treated with the recommended therapeutic dose, systemic exposure exceeded that of humans.
Ma kien hemm l- ebda sinjali oħrajn ta ’ tossiċità, madankollu, fil- klieb ittrattati bid- doża terapewtika rrakkomandata, għalkemm l- espożizzjoni sistemika kienet aktar minn dik tal- bniedem.
The genotoxicity of temoporfin has been investigated to a limited extent.
Il- ġenotossiċità ta ’ temoporfin kienet investigata sa ċertu punt.
Due to the generation of reactive oxygen species, temoporfin poses a minor risk of mutagenicity.
Minħabba l- ġenerazzjoni ta ’ speċi ossiġnu reattiv, temoporfin iġib miegħu riskju minuri ta ’ mutaġeniċità.
This risk can be controlled in the clinical situation by minimising direct exposure to light (see section 4.4).
Dan ir- riskju jista ’ jiġi kkontrollat fis- sitwazzjoni klinika billi jitnaqqas l- espożizzjoni diretta għad- dawl (ara sezzjoni 4. 4).
In developmental toxicity studies in rabbits, temoporfin, at systemic exposures equal to those obtained in humans with the recommended therapeutic dose, caused an increase in early post-implantation loss.
Fi studju dwar it- tossiċità ta ’ temoporfin, fuq l- iżvilupp tal- fniek, f’ espożizzjonijiet sistemiċi ugwali għal dawk miksuba mill- bniedem fid- doża terapewtika rakkomandata, wassal għal żjieda ta ’ telfien wara l- impjantazzjoni.
Although no other developmental effects were observed, the applied doses were not sufficiently in excess of the human therapeutic dose to provide an adequate margin of safety.
Għalkemm ma kienu osservati l- ebda effetti oħrajn fl- iżvilupp, id- dożi applikati ma kienux suffiċjentament ikbar mid- doża terapewtika għall- bniedem biex tiġi provduta firxa adegwata ta ’ sigurtà.
6.1 List of excipients
Lista ta ’ sustanzi mhux attivi 6. 1
Ethanol, anhydrous (E1510) Propylene glycol (E1520)
Ethanol, mhux idrat (E1510) Propylene glycol (1520)
7 6.2 Incompatibilities
7 6. 2 Inkompatibilitajiet
In the absence of incompatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux miegħu, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn, ħlief dawk imsemmija f’ sezzjoni 6. 6.
Do not dilute with aqueous solutions.
Tiddilwix ma ’ soluzzjonijiet likwidi.
Once opened, the solution must be used immediately.
La darba tinfetaħ is- soluzzjoni għandha tintuża minnufih.
Do not store above 25oC.
Taħżinx f’ temperatura `l fuq minn 25C.
Foscan is supplied in 6 ml Type I amber glass vials with a bromobutyl elastomer stopper and aluminium seal.
Foscan jiġi f’ kunjetti tal- ħġieġ ambra ta ’ Tip I ta ’ 6 ml li fihom għatu elastomer tal- bromobutyl u siġġill ta ’ l- aluminju.
The vials contain 1 ml, 3 ml or 6 ml of solution for injection.
Il- kunjetti fihom soluzzjoni għall- injezzjoni ta ’ 1 ml, 3 ml jew 6 ml.
Each pack contains 1 vial and a filter with Luer lock connections for syringe and cannula.
Kull pakkett fih kunjett wieħed u filtru b’ konnessjonijiet biex jista ’ jeħel mas- siringa u mal- kannula b’ Luer lock.
The filter is contained in a polyethylene container.
Il- filtru jinsab fir- reċipjent tal- polyethylene.
Appropriate precaution must be taken when handling this medicinal product.
Għandhom jittieħdu l- prekawzjonijiet xierqa waqt l- immaniġġar ta ’ dan il- prodott mediċinali.
Studies have shown that Foscan is non-irritant.
Studji wrew li Foscan mhux irritanti.
Each vial represents a single dose and any unused solution must be discarded.
Kull kunjett tirrapreżenta doża waħda u kull soluzzjoni mhux użata għandha tintrema.
Foscan is photosensitive.
Foscan hu fotosensittiv.
Once removed from its packaging it must be administered immediately.
Hekk kif jitneħħa mill- kartuna għandu jingħata minnufih.
Where delay is unavoidable, the solution must be protected from light.
Meta ma jkunx jista ’ jittieħed mill- ewwel, is- soluzzjoni għandha tiġi mħarsa mid- dawl.
United Drug House Magna Drive Dublin 24 Ireland
United Drug House Magna Drive Dublin 24 L- Irlanda
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ 8.
24 October 2001 Date of last renewal:
24 t ’ Ottubru 2001 Data ta ’ l- aħħar tiġdid:
24 October 2006
24 t ’ Ottubru 2006
DATE OF REVISION OF THE TEXT
8 DATA TA ’ META ĠIET RIVEDUTA L- KITBA 10.
NAME OF THE MEDICINAL PRODUCT
9 ISEM TAL- PRODOTT MEDIĊINALI 1.
Foscan 4 mg/ ml solution for injection
Foscan 4 mg/ ml soluzzjoni għall- injezzjoni
QUALITATIVE AND QUANTITATIVE COMPOSITION
GĦAMLA KWALITATTIVA U KWANTITATTIVA 2.
Each ml contains 4 mg of temoporfin.
Kull ml fih 4 mg ta ’ temoporfin.
4.3 Posology and method of administration
Pożoloġija u metodu ta ’ kif għandu jingħata 4. 2
9 Each field is to be illuminated once only at each treatment.
10 Kull parti għandha tiġi lluminata darba biss matul kull trattament.
As a precautionary measure, if prolonged outdoor activity is planned, the injection arm should be protected by wearing a long sleeved, coloured shirt.
Bħala miżura ta ’ prekawzjoni, jekk xi 12 attività fuq barra hija ppjanata għal tul ta ’ ħin, id- driegħ injettat għandu jiġi protett billi tintlibes qmis b’ komma twila kkulurita.
11 This product contains 48 vol% ethanol (alcohol), i. e up to 1.0 g per dose, equivalent to 21 ml of beer, 9 ml wine per dose.
Dan il- prodott fih 48 vol% ta ’ ethanol (alkoħol), i. e sa 1. 0 g f’ kull doża, li hija ekwivalenti għal 21 ml ta ’ birra, 9 ml inbid għal kull doża.
To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.
Dan għandu jiġi kkunsidrat f ’ nisa tqal jew li qed ireddgħu, tfal, u dawk il- gruppi li jinsabu f’ riskju bħal pazjenti b’ mard tal- fwied jew bl- epilessija.
4.9 Undesirable effects
4. 8 Effetti mhux mixtieqa
Blood and lymphatic system disorders Common effects: anaemia.
Infezzjoni u Infestazzjoni Effetti komuni: infezzjoni lokalizzata.
Gastrointestinal disorders Very common effects: constipation.
Disturbi tad- demm u tas- sistema limfatika Effetti komuni: anemija 13 Disturbi gastro- intestinali Effetti komuni ħafna: stitikezza.
12 Skin and subcutaneous tissue disorders Common effects: blisters, erythema, burn, skin hyperpigmentation, photosensitivity reaction, sunburn, skin necrosis.
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Effetti komuni: infafet, ġilda fl- aħmar, ħruq, iperpigmentazzjoni tal- ġilda, reazzjoni fotosensittiva, ħruq tax- xemx, nekrosi tal- ġilda.
The pharmacological activity is initiated by photoactivation of temoporfin with non-thermal light at 652nm following intravenous administration.
L- attività farmakoloġika tinbeda b' fotoattivazzjoni ta ’ temoporfin b’ dawl mhux termali ta '652 nm wara li jingħata ġol- vina.
In a clinical trial of 147 patients with advanced head and neck squamous cell carcinoma, tumour response, defined as a reduction of a minimum of 50% of the tumour mass for a minimum of four weeks, was observed in 25% after a single treatment.
14 Fi prova klinika li saret fuq 147 pazjent b’ karċinoma avvanzata taċ- ċellula skwamużi fir- ras u fl- għonq, riżultat pożittiv fuq it- tumur, definit bħala tnaqqis ta ’ minimu ta ’ 50% tal- massa tat- tumur għallinqas għal erba ’ ġimgħat, kien osservat f’ 25% tal- pazjenti wara trattament wieħed.
13 The median observed duration of tumour response for all patients was 57 days for overall response and 84 days for complete response.
Iż- żmien medju ta ’ kemm dam l- effett fuq it- tumur għall- pazjenti kollha kien ta ’ 57 jum għar- riżultat ġenerali u 84 jum għar- riżultat komplut.
No other signs of toxicity were found, however, in dogs treated with the recommended therapeutic dose, systemic exposure exceeded that of humans.
Ma kien hemm l- ebda sinjali oħrajn ta ’ tossiċità, madankollu, fil- klieb ittrattati bid- doża terapewtika rrakkomandata, għalkemm l - espożizzjoni sistemika kienet aktar minn dik tal- bniedem.
In the absence of incompatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6. 2 Inkompatibilitajiet 15 Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux miegħu, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn, ħlief dawk imsemmija f’ sezzjoni 6. 6.
14 6.3 Shelf life
Żmien kemm idum tajjeb il- prodott mediċinali 6. 3
The vials contain 3.5 ml, or 5 ml of solution for injection.
Il- kunjetti fihom soluzzjoni għall- injezzjoni ta ’ 3. 5 ml jew 5 ml.
CONDITIONS OF THE MARKETING AUTHORISATION
DATA TA ’ META ĠIET RIVEDUTA L- KITBA 10.
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Name and address of the manufacturer responsible for batch release
17 DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI A.
United Drug House Magna Drive Dublin 24 Ireland.
United Drug House Magna Drive Dublin 24 L- Irlanda
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ B.
Summary of Product Characteristics, section 4.2)
Sommarju tal - Karatteristiċi tal- Prodott, sezzjoni 4. 2).
18 A.
18 ANNESS III
19 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA
OUTER CARTON OF 1 MG/ ML
KARTUNA TA ’ BARRA, 1 MG/ ML
NAME OF THE MEDICINAL PRODUCT
ISEM TAL- PRODOTT MEDIĊINALI 1.
Foscan 1 mg/ ml solution for injection Temoporfin
Foscan 1 mg/ ml soluzzjoni għall- injezzjoni Temoporfin
LIST OF EXCIPIENTS
Kull ml fih 1 mg ta ’ temoporfin.
Ethanol anhydrous and propylene glycol (see package leaflet for further information).
GĦAMLA FARMAĊEWTIKA U KONTENUT 4.
Solution for injection 1 ml Solution for injection 3 ml Solution for injection 6 ml Sterile filter
Soluzzjoni għall- injezzjoni 1 ml Soluzzjoni għall- injezzjoni 3 ml Soluzzjoni għall- injezzjoni 6 ml Filtru sterili
METHOD AND ROUTE(S) OF ADMINISTRATION
MOD TA ’ KIF U MNEJN JINGĦATA 5.
Read the package leaflet before use.
Użu għal ġol- vini Aqra l- fuljett ta ’ tagħrif qabel l- użu.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
JINTLAĦAQX U MA JIDHIRX MIT- TFAL
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJA( IET) SPEĊJALI OĦRA, JEKK MEĦTIEĠA 7.
Single dose.
Doża waħda.
Discard the remainder after use.
Armi dak li jifdal wara l- użu.
EXPIRY DATE
DATA TA ’ META JISKADI 8.
EXP
JIS {xahar/ sena}
Store in the original package in order to protect from light.
Taħżinx f’ temperatura ’ l fuq minn 25oC Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
FIS- SUQ
United Drug House Magna Drive Dublin 24 Ireland
United Drug House Magna Drive Dublin 24, L- Irlanda
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ 12.
Justification for not including Braille accepted
Il- Ġustifikazzjoni li ma jkunx inkluż il- Braille hija aċċettata
VIAL LABEL OF 1 MG/ ML
TIKKETTA TAL- KUNJETT, 1 MG/ ML
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
ISEM TAL- PRODOTT MEDIĊINALI U MNEJN GĦANDU JINGĦATA 1.
Foscan 1 mg/ ml solution for injection Temoporfin Intravenous use
Foscan 1 mg/ ml soluzzjoni għall- injezzjoni Temoporfin Użu għal ġol- vini
METHOD OF ADMINISTRATION
METODU TA ’ KIF GĦANDU JINGĦATA 2.
For intravenous injection.
Għal injezzjoni għal ġol- vini.
Read the package leaflet before use.
Aqra l- fuljett tat- tagħrif qabel l- użu.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
IL- KONTENUT SKOND IL- PIŻ, VOLUM, JEW PARTI INDIVIDWALI 5.
OTHER
OĦRAJN 6.
OUTER CARTON OF 4 MG/ ML
KARTUNA TA ’ BARRA, 4 MG/ ML
Foscan 4 mg/ ml solution for injection Temoporfin
Foscan 4 mg/ ml soluzzjoni għall- injezzjoni Temoporfin
LIST OF EXCIPIENTS
LISTA TA ’ SUSTANZI MHUX ATTIVI 3.
Solution for injection 3.5 ml Solution for injection 5.0 ml Sterile filter
Soluzzjoni għall- injezzjoni 3. 5 ml Soluzzjoni għall- injezzjoni 5. 0 ml Filtru sterili
EU/ 1/ 01/ 197/ 001 (3.5 ml) EU/ 1/ 01/ 197/ 002 (5 ml)
EU/ 1/ 01/ 197/ 001 (3. 5 ml) EU/ 1/ 01/ 197/ 002 (5 ml)
VIAL LABEL OF 4 MG/ ML
TIKKETTA TAL- KUNJETT, 4 MG/ ML
Foscan 4 mg/ ml solution for injection Temoporfin Intravenous use
Foscan 4 mg/ ml soluzzjoni għall- injezzjoni Temoporfin Użu għal ġol- vini
14 mg/ 3.5 ml 20 mg/ 5.0 ml
14 mg/ 3. 5 ml 20 mg / 5. 0 ml
26 PACKAGE LEAFLET:
26 B.
- If you have further questions, please ask your doctor or your pharmacist.
Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
please tell your doctor or your pharmacist
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek
1.
X’ inhu Foscan u għalxiex jintuża 1.
Before you use Foscan 3.
Qabel ma tuża Foscan Kif għandek tuża Foscan 3.
Possible side effects 5.
Effetti kollaterali li jista ’ jkollu 4.
How to store Foscan 6.
Kif taħżen Foscan 5.
Further information
Aktar tagħrif 6.
WHAT FOSCAN IS AND WHAT IT IS USED FOR
X’ INHU FOSCAN U GĦALXIEX JINTUŻA 1.
Foscan is a porphyrin photosensitising medicine.
Foscan huwa, mediċina porfirina fotosensitizzanti.
Foscan is used for the treatment of head and neck cancer in patients who cannot be treated with other therapies.
Foscan jintuża għat- trattament ta ’ kanċer tar- ras u tal- għonq f’ pazjenti li ma jistgħux jiġu ttrattati b’ terapiji oħra.
BEFORE YOU USE FOSCAN
QABEL MA TUŻA FOSCAN 2.
- if you are hypersensitive (allergic) to temoporfin or any of the ingredients of Foscan,
Tużax Foscan jekk tbati minn sensittività eċċessiva (allerġija) għal temoporfin jew xi ingredjenti oħra ta ’
- if you are hypersensitive (allergic) to porphyrins,
Foscan jekk tbati minn sensittività eċċessiva (allerġija) għal porphyrins
- if you have porphyria, or any other disease that is made worse by light,
jekk għandek porfirja jew mard ieħor li jista 'jiggrava bid- dawl
- if the tumour being treated goes through a large blood vessel,
jekk it- tumur li qed jiġi kkurat jgħaddi minn xi vina/ arterja prinċipali
- if you are going to have an operation in the next 30 days,
jekk se tagħmel xi operazzjoni fi żmiem 30 ġurnata
- if you have an eye disease which needs examination with bright light in the next 30 days,
jekk għandek mard f’ għajnejk li jeħtieġ li jiġi eżaminat b’ dawl qawwi fit- 30 ġurnata li jmiss
- if you are already being treated with a photosensitising agent.
jekk diġà qed tiġi kkurat permezz ta ’ sustanza fotosensitizzanti
Take special care with Foscan Foscan will make you sensitive to light for about 15 days after your injection.
Oqgħod attent ħafna b’ Foscan Foscan se jagħmlek sensittiv għad- dawl għal madwar 15- il ġurnata wara l- injezzjoni.
This means that normal daylight or bright indoor lighting could give you skin burns.
Dan ifisser li dawl normali tax- xemx jew dawl qawwi ta ’ ġewwa jista ’ jaħraqlek il- ġilda.
To stop this, you MUST follow carefully the instructions for gradual exposure to increasing light levels indoors over the first week and outdoor, shaded light during the second week after treatment.
Biex twaqqaf dan milli jseħħ, int GĦANDEK issegwi b' attenzjoni l- istruzzjonijiet għall- espożizzjoni gradwali biex iżżid il- livelli tad- dawl ta ’ ġewwa matul l- ewwel ġimgħa u dawl fid- dell ta 'barra matul it- tieni ġimgħa ta ’ wara l- kura.
Please speak to your doctor about this before you go home after being injected with Foscan.
Jekk jogħġbok kellem lit- tabib tiegħek dwar dan qabel ma tmur id- dar wara li tkun ġejt injettat b’ Foscan.
Sunscreen creams will not prevent this sensitivity.
Kremi li jipproteġu l- ġilda mix- xemx mhux se jevitaw din is- sensittività.
You will gradually become less sensitive to light.
Bil- mod il- mod, issir inqas sensittiv għad- dawl.
Normally, people are able to begin to return to normal outdoor lighting after 15 days.
Normalment, il- persuni jistgħu jerġgħu lura għad- dawl normali ta ’ barra wara 15- il ġurnata.
You must not let an optician or ophthalmologist examine your eyes with bright lights for 30 days after Foscan injection.
M' għandekx tħalli lil tekniku jew lil speċjalista tal- għajnejn jeżaminalek għajnejk b’ dawl qawwi, għal 30 jum wara injezzjoni b' Foscan.
You must not use UV sunbeds or sunbathe for 3 months after Foscan injection.
M’ għandekx tuża sodod tax- xemx tal- UV jew toqgħod tixxemmex għal 3 xhur wara injezzjoni b’ Foscan.
For 6 months following Foscan treatment, avoid prolonged direct sunlight exposure of the injection site arm.
Għal 6 xhur wara l- għoti tat- terapija ta ’ FOSCAN tikxifx is- sit ta ’ l- injezzjoni għax- xemx għal żmien twil.
As a precautionary measure, if prolonged outdoor activity is planned, protect your injection arm by wearing a long sleeved, coloured shirt.
Bħala miżura ta ’ prekawzjoni, jekk xi attività fuq barra hija ppjanata għal tul ta ’ ħin, id- driegħ injettat għandu jiġi protett billi tilbes qmis b’ komma twila kkulurita.
27 The table of instructions tells you what to do to prevent skin burns.
28 It- tabella ta ’ struzzjonijiet tgħidlek x’ għandek tagħmel biex tevita l- ħruq tal- ġilda.
You must follow these instructions carefully.
Għandek issegwi dawn l- istruzzjonijiet b’ attenzjoni.
Please ask your doctor, nurse or pharmacist if you are not sure about anything.
Jekk jogħġbok staqsi lit- tabib, lill- infirmiera jew lill- ispiżjar tiegħek jekk m’ intix ċert dwar xi ħaġa.
Foscan Injection Day 1 (0-24 hours)
l- Injezzjoni ta ’ Foscan L- 1 Ġurnata (0 - 24 siegħa)
Keep the curtains drawn and use light bulbs of 60W or less.
Żomm il- purtieri magħluqin u uża bozzoz ta ’ 60 W jew anqas.
Remember to avoid direct sunlight coming through the window or direct light from household appliances such as reading lamps.
Ftakar li għandek tevita dawl tax- xemx dirett mit- tieqa jew dawl dirett minn tagħmir tad- dar bħal lampi tal- qari.
You may watch television.
Tista ’ tara t- televiżjoni.
You can go outdoors after dusk.
Tista ’ toħroġ mid- dar wara li tinżel ix- xemx.
Long trousers: for lower body/ legs.
Kappell bil- faldi wiesa: għar- ras, għonq, imnieħer u widnejn Xalla: għar- ras u għonq Nuċċali tax- xemx b’ pannelli tal- ġemb: għall- għajnejn u l- ġilda ta ’ madwar l- għajnejn Flokk tal- komma twila: għall- parti ta ’ fuq tal- ġisem/ dirgħajn Qalziet twil: għall- parti t’ isfel tal- ġisem/ riġlejn Ingwanti: għall- idejn, polz u swaba Kalzetti: għas- saqajn u l- għekiesi Żarbun magħluq: għas- saqajn Tilbisx ħwejjeġ ħfief ħafna, għaliex ma jħarsukx mid- dawl qawwi.
Gloves: for hands, wrist and fingers.
Ilbes ħwejjeġ skuri, minsuġin tajjeb.
Do not wear very thin clothing because it will not protect you from strong light.
Jekk tesponi ruħek għad- dawl bi żball, tista tħoss il- ġilda tniggeż jew taħraq.
Wear dark, closely woven clothing.
Oħroġ mid- dawl immedjatament.
If there is no redness, you can gradually increase your exposure to sunlight day by day.
Jekk m’ hemmx ħmura, tista ’ bil- mod tibda żżid l- espożizzjoni tiegħek għax - xemx ġurnata b’ ġurnata.
For 6 months following Foscan treatment, care should be taken to avoid direct prolonged sunlight exposure of the arm used for Foscan injection.
Għal 6 xhur wara l- għoti tat- terapija ta ’ FOSCAN evita l- espożizzjoni prolongata diretta tas- sit ta ’ l- injezzjoni għax- xemx.
As a precautionary measure, if prolonged outdoor activity is planned, the injection arm should be protected by wearing a long sleeved, coloured shirt.
Bħala miżura ta ’ 30 prekawzjoni, jekk xi attività fuq barra hija ppjanata għal tul ta ’ ħin, id- driegħ injettat għandu jiġi protett billi tintlibes qmis b’ komma twila kkulurita.
28 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Using Foscan with food and drink:
Meta tieħu Foscan ma ’ l- ikel u max- xorb:
Your normal food and drink will not affect your treatment with Foscan
L- ikel u x- xorb normali tiegħek mhux se jaffettwaw il- kura tiegħek b’ Foscan.
Pregnancy You must avoid becoming pregnant for 3 months after Foscan treatment.
Tqala Int għandek tevita li toħroġ tqila sa 3 xhur wara l- kura b’ Foscan.
Ask you doctor or pharmacist for advice before taking any medicine if you are pregnant
Itlob għall- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina jekk inti tqila.
Breast-feeding Do not breastfeed for at least 1 month after Foscan injection.
Jekk qed tredda ’ Treddax għal ta 'l- anqas xahar wara l- injezzjoni.
Driving and using machines The amount of alcohol in this product may impair your ability to drive or use machines for a few hours after injection.
L- ammont ta ’ alkoħol f’ dan il- prodott jista ’ jimpedixxi l- ħila tiegħek biex issuq jew tħaddem magni għal ftit sigħat wara l- injezzjoni.