FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Maltese: 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.
English: 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.
Maltese: L-użu ta' kortikosterojdi bħala prevenzjoni biex inaqqsu it-tidjiq, għandu jiġi evitat waqt terapija fotodinamika.
English: − Photosensitivity can only be prevented by avoiding exposure to the sun for 90 days after receiving the PhotoBarr injection
Maltese: − Fotosensittività tista' tiġi evitata billi ma jkunx hemm espożizzjoni għax-xemx għal 90 jum wara li tirċievi injezzjoni ta' PhotoBarr
English: NA
Maltese: Tqala
English: The influence of renal and hepatic impairment on exposure to porfimer sodium has not been evaluated (see sections 4.2, 4.3 and 4.4).
Maltese: L-influwenza ta'l-indeboliment tal-kliewi u tal-fwied fuq l-espożizzjoni ta' porfimer sodium ma ġiex mistħarreġ (ara sezzjonijiet 4.2, 4.3 u 4.4).
English: 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.
Maltese: Mhux komuni: 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 limsaren, halitosis, emorraġija fl-esofagu, esofaġite ulċerativa, skumdita addominali, distensjoni addominali, toqob fl-esofagu.
English: High-grade dysplasia in Barrett's oesophagus of < 7 cm
Maltese: Displasja qawwija fl-esofagu ta' Barrett li huwa < 7 ċm Proċedura
English: Porfimer sodium was not mutagenic in standard genotoxicity tests in the absence of light.
Maltese: Porfimer sodium ma kienx mutaġeniku f'testijiet ġenotossiċi standard fl-assenza tad-dawl.
English: These results confirm those observed after a minimum of 6 months follow-up which showed HGD ablation in 72% of patients in the PhotoBarr PDT + OM group compared to 31% in the OM only group.
Maltese: Dawn ir-riżultati jikkonfermaw oħrajn li wara mill-anqas sorveljanza ta' 6 xhur kien hemm fejqan minn HGD f' 72% tal-pazjenti li kienu filgrupp PhotoBarr PDT + OM, meta mqabbla ma' 31% fil-grupp OM biss.
English: Hydrochloric acid (for pH-adjustment)
Maltese: Aċidu idrokloriku (għal aġġustament tal-pH)
English: After reconstitution, each ml solution contains 2.5 mg porfimer sodium.
Maltese: Wara r-rikostituzzjoni, kull ml ta' soluzzjoni fiha 2.5 mg porfimer sodium.
English: PhotoBarr PDT + OM was effective in eliminating HGD in patients with BO.
Maltese: PhotoBarr PDT + OM kien effettiv biex inneħħi
English: Avoid direct exposure to bright indoor lights, including dental lamps, operating room lamps, unshaded light bulbs at close proximity or neon lights.
Maltese: Evita l-espożizzjoni diretta ta' dawl luminanti ta' ġewwa, li jinkludu l-lampi tad-dentist, lampi li jintużaw għal interventi kiruġiċi, lampi mingħajr lqugħ u li toqgħod qrib ta' dawl tan-neon.
English: Ocular sensitivity
Maltese: Jittieħed ilfotosensitizzatur
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 15 mg
Maltese: INDIVIDWALI 15 mg
English: PhotoBarr is contraindicated in patients with severe hepatic impairment.
Maltese: PhotoBarr huwa kontraindikat f'pazjenti b'indeboliment epatiku sever.
English: For storage conditions of the reconstituted medicinal product, see section 6.3.
Maltese: Għal kundizzjonijiet ta' ħażna tal-prodott mediċinali rikostitwit, ara sezzjoni 6.3
English: o Patients should be instructed to seek medical advice if signs/symptoms suggestive of photosensitivity occur during or after therapy with porfimer.
Maltese: o Pazjenti għandhom jingħataw struzzjonijiet sabiex ifittxu attenzjoni medika jekk ikun hemm sinjali/sintomi ta' fotosensittività waqt u wara t-terapija b'porfimer.
English: Pregnancy and breast-feeding
Maltese: Nutrizzjoni tal-Pazjenti
English: Cellular damage caused by porfimer sodium PDT is a consequence of the propagation of free radical reactions.
Maltese: Il-ħsara li tiġri liċċelluli minħabba t-terapija fotodinamika PhotoBarr hija konsegwenza tar-reazzjonijiet li jinvolvu radikali liberi.
English: PhotoBarr is a light-activated medicine used photodynamic therapy (PDT)in combination with a non-burning, red laser light.
Maltese: PhotoBarr hija mediċina attivata bid-dawl f'terapija fotodinamika (PDT), f' kombinazzjoni ma' dawl laser aħmar li ma jaħraqx.
English: Women of childbearing age should take adequate contraceptive precautions whilst and up to 90 days after receiving PhotoBarr.
Maltese: Nisa li huma ta' età li jista t-tfal għandhom jieħdu prekawzjonijiet xierqa waqt li qed jingħataw PhotoBarr u sa 90 jum wara li tkun irċevejt PhotoBarr.
English: Blister, post procedural haemorrhage
Maltese: Nuffat, emorraġija post-proċedurali
English: 4.8 Undesirable effects a. Summary of safety profile
Maltese: Sommarju tal-profil tas-sigurtà
English: b.Tabulated summary of adverse reactions
Maltese: Tabella ta' sommarju ta' reazzjonijiet avversi
English: Required Power Output from Diffuser a
Maltese: Rata ta' enerġija meħtieġa a
English: The influence of hepatic impairment on exposure to porfimer sodium has not been evaluated (see section 4.3 and 4.4).
Maltese: L-influwenza ta' indeboliment fil-fwied minħabba l-espożizzjoni għal porfimer sodium ma ġietx evalwata (ara sezzjonijiet 4.3 u 4.4)
English: Uncommon side effects difficulty breathing, decrease in level of oxygen, choking, swelling of the airways, fluid in airways, shortness of breath during physical activity, wheezing, coughing up more phlegm, coughing up blood, stuffy nose lung infection, sinus infection chest pain or heart attack, high blood pressure or low blood pressure, chest discomfort abnormal blood test results, including increase in white blood cells, low potassium levels bleeding, loss of blood, increased tendency to bruise over development of breasts in men, inability to urinate, temperature intolerance, cold sweats, night sweats general swelling, general pain, musculoskeletal chest pain, stiffness of joint, inflammation of the heel shakes, restlessness, dizziness, numbness, flushes, feeling weak, feeling unwell loss of hearing, ringing in the ears, swelling of the eye, eye pain rash, redness at the injection site, nail fungal infection, skin infection, blister, itchy skin, overgrowth of tissue at the site of skin injury, scar pain, scab, presence of skin moles, abnormal hair growth
Maltese: - emorragija, tendenza ogħla biex titbenġel - l-iżvilupp żejjed ta' sider fl-irġiel, ma tistax tgħaddi awrina, intolleranza għat-temperatura, togħriq fil-kesħa - nefħa ġenerali, uġigħ ġenerali, uġigħ fis-sider muskoluskeletriku, ebusija tal-ġog, infjammazzjoni tal-għarqub - rogħda, irrikwitezza, tħossok sturdut, tnemnim, fwawar, tħossok debboli, tħossok ma tiflaħx. - telf tas-smigħ, ċenċil fil-widnejn, nefħa fl-għajnejn, uġigħ fl-għajnejn. raxx, ħmura fis-sit tal-injezzjoni, infezzjoni fungali fid-dwiefer, infezzjoni tal-ġilda, infafet, - ħakk fuq il-ġilda, uġigħ minn ġerħa, il-preżenza ta' tbajja' fuq il-ġilda, xagħar jikber mhux normali.
English: The majority of treatment-associated oesophageal stenosis (which includes oesophageal narrowing and oesophageal strictures) reported in the PhotoBarr PDT + OM group were of mild or moderate intensity (92%).
Maltese: Fil-biċċa l-kbira ta' trattamenti assoċjati ma' stenożi tal-esofagu (li jinkludu tidjiq u kontrazzjonijiet flesofagu) li ġew rapportati fil-grupp ta' PhotoBarr PDT + OM, kienu ta' natura hafifa jew moderata (92%).
English: Summary of adverse reactions with porfimer sodium
Maltese: Sommarju ta' reazzjonijiet mhux mixtieqa b'porfimer sodium
English: Some other medicines may increase the risk for photosensitivity reactions for example antibiotics or antidiabetic medicines.
Maltese: Xi mediċini jistgħu jgħollu r-riskju ta' reazzjonijiet ta' fotosensittività pereżempju, antibijotiċi u/jew prodotti tad-dijabete.
English: 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.
Maltese: 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.
English: LIST OF EXCIPIENTS
Maltese: Espożizzjoni aċċidentali
English: 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).
Maltese: 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).
English: These manifestations may be attributable to a pseudoporphyria state (temporary medicinal product-induced cutaneous porphyria).
Maltese: Dawn l-effetti setgħu ġew ikkaġunati minħabba stat ta' pseudoporfirja (porfirja fil-ġilda stimulata minn prodotti mediċinali).
English: In clinical trials, PhotoBarr PDT has only been tested in patients being treatment naive concerning mucosal ablative therapy.
Maltese: Terapija fotodinamika b'PhotoBarr ġiet ippruvata waqt provi kliniċi fuq pazjenti mhux konxji mit-trattament ta' asportazzjoni mukuża.
English: Gender had no effect on pharmacokinetic parameters except for tmax, which was approximately 1.5 hours in women and 0.17 hours in men.
Maltese: Il-ġeneru ma kellux effett fuq il-fatturi farmakokinetiċi, minbarra tmax, li kellha valur ta' 1.5 sigħat finnisa u 0.17 sigħat fl-irġiel.
English: Comparison between the survival curves of the two treatment arms using the log rank test showed a statistically significant difference between the curves of the two groups in the ITT population (p=0.0014) indicating a significant delay in the progression to cancer.
Maltese: Meta il-kurvi tas-sopravivenza taż-żewġ trattamenti jiġu mqabbla permezz ta' test log rank, wieħed issib li hemm differenza li hija statistikament sinifikanti bejn iż-żewġ kurvi taż-żewġ gruppi tal-popolazzjoni ITT(p=0.0014).
English: Clearance from a variety of tissues occurs over 40-72 hours, but tumours, skin, and organs of the reticuloendothelial system (including liver and spleen) retain porfimer sodium for a longer period.
Maltese: Ir-rata ta' eliminazzjoni ta' PhotoBarr minn tessuti diversi tieħu l-fuq minn 40-72 sigħat, iżda tumuri, ġilda, u l-organi tas-sistema retikulo-endoteljali (li jinkludu l-fwied u l-milsa) iżżommu porfimer sodium għal perjodu itwal.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION PhotoBarr 75 mg powder for solution for injection Porfimer sodium
Maltese: PhotoBarr 75 mg trab għal soluzzjoni għall-injezzjoni Porfimer sodium
English: nausea*
Maltese: FIS-SUQ
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial 15 mg - 7 ml
Maltese: Ż-ŻGĦAR EWLENIN Kunjett ta' 15 mg - 7 ml
English: Renal impairment The influence of renal impairment on exposure to porfimer sodium has not been evaluated (see section
Maltese: L-influwenza ta' indeboliment fil-kliewi minħabba l-espożizzjoni għal porfimer sodium ma ġietx evalwata (ara sezzjoni 4.3).
English: - Porphyria.
Maltese: DIKJARAZZJONI
English: For most patients (up to 75 kg) two vials of PhotoBarr 75 mg will suffice.
Maltese: Għal biċċa l-kbira tal-pazjenti (sa 75 kg) żewġ kunjetti ta' PhotoBarr 75 mg huma biżżejjed.
English: Patients older than 75 years may be at a higher risk of respiratory related adverse events such as pleural effusion and dyspnoea.
Maltese: Pazjenti li għandhom iktar minn minn 75 sena jista' jkollhom riskju akbar minħabba effetti avversi fissistema respiratorja, bħal effużjoni plewrali u qtugħ ta' nifs.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER PhotoBarr 15 mg powder for solution for injection Porfimer sodium
Maltese: PhotoBarr 15 mg trab għal soluzzjoni għall-injezzjoni Porfimer sodium
English: However, because of its potential to induce photosensitivity, PhotoBarr might be an eye and/or skin irritant in the presence of bright light.
Maltese: Madankollu, minħabba l-probabilità li tiġi indotta fotosensittività, PhotoBarr jista' jkun irritant tal-għajnejn u/jew tal-ġilda filpreżenza ta' dawl luminuż.
English: The recommended 2 mg/kg dose, instead of the recommended single administration, was given twice two days apart (10 patients) and three times within two weeks (1 patient), without any notable adverse reactions being reported.
Maltese: Dożi ogħla tal-prodott mediċinali minn dawk rakkomandati ta' 2 mg/kg, ngħataw f'intervall ta' jumejn (f'10 pazjenti), u tlett dożi ta' 2 mg/kg, li ngħataw f'intervall ta' ġimagħtejn (f'pazjent wieħed), kienu tollerati mingħajr reazzjonijiet avversi.
English: affects 1 to 10 users in 10,000
Maltese: li jaffettwaw aktar minn 1 sa 10 utenti f'kull 10,000
English: Based on preclinical studies, acceptable light intensity for the balloon/diffuser combination ranges from 175-270 mW/cm of diffuser.
Maltese: 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.
English: General disorders and administration site conditions Very common: Pyrexia
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Mhux komuni: Gynaecomastia
English: Photodynamic therapy with PhotoBarr is a 2-stage process.
Maltese: Terapija fotodinamika b' PhotoBarr tikkonsisti f'żewġ stadji.
English: Sodium hydroxide (for pH-adjustment)
Maltese: Idrossidu tas-sodju (għal aġġustament tal-pH)
English: Embolism, Deep vein thrombosis, Phlebitis Respiratory, thoracic and mediastinal disorders Common:
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Komuni:
English: Method of administration For instructions on reconstitution prior to administration, see section 6.6.
Maltese: Mod ta' amministrazzjoni Għal struzzjonijiet dwar ir-rikostituzzjoni qabel l-għoti, ara sezzjoni 6.6.
English: Common side effects back pain, pain in arms and legs, pain due to treatment headache, feeling nervous, tingling feeling, problems sleeping abdominal stiffness, stomach pain, vomiting blood disorders of the gullet such as ulcer, irritation or constriction loose stools, passing dark tarry stool, sore throat, hiccups, belching fluid in chest, chest pain, fast heart beat, shortness of breath, shakes due to high fever, chills loss of weight, decrease in appetite, feeling tired, loss of taste skin ulcer, rash, itchiness, hives, change in skin colour, scratch, scar, abnormal tissue, bump on the skin, very small cysts in the skin, dry and fragile skin
Maltese: 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 Mhux komuni: 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.
English: Forty-one percent of patients showed normal squamous cell epithelium and 49% had absence of dysplasia.
Maltese: Wieħed u erbgħin fil mija tal-pazjenti urew li kellhom ċelluli tal-epitelju squamous anormali, filwaqt li 49% ma kellhomx displasja.
English: Medicinal products that decrease clotting, vasoconstriction or platelet aggregation, e.g., thromboxane A2 inhibitors, could decrease the efficacy of PDT.
Maltese: 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.
English: Hepatic Impairment
Maltese: Infezzjonijiet u infestazzjonijiet
English: Hydrochloric acid, sodium hydroxide (for pH adjustment).
Maltese: - Is-sustanzi l-ohra huma hydrochloric acid u/jew sodium hydroxide (għal aġġustament ta'
English: 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.
Maltese: Ittieni 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.
English: pyrexia (20%), dysphagia (19%), constipation (13%), dehydration (12%) and nausea (11%).
Maltese: 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%).
English: PhotoBarr should be administered as a single slow intravenous injection over 3 to 5 minutes.
Maltese: PhotoBarr għandu jingħata bħala injezzjoni waħda intravenuża bil-mod. L-injezzjoni ddum tingħata 'l fuq minn 3 minuti sa 5 minuti.
English: 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.
Maltese: Waqt studju farmakokinetiku, bit-tikketta tidher, kull wieħed minn 24 suġġett kellhom reazzjonijiet minħabba sensittività eċċessiva għad dawl.
English: Increased symptoms and damage to normal tissue might be expected following an overdose of light.
Maltese: Huwa mistenni li jkun hemm żieda fis-sintomi u ħsara lit-tessut normali meta jkun hemm espożizzjoni eċċessiva għad-dawl.
English: NAME OF THE MEDICINAL PRODUCT PhotoBarr 75 mg powder for solution for injection
Maltese: PhotoBarr 75 mg trab għal soluzzjoni għall-injezzjoni.
English: Joint contracture, joint range of motion decreased, musculoskeletal chest pain,
Maltese: Mhux komuni: Ġbid fil-ġogi, tnaqqis fil-movimenti tal-ġogi, uġigħ fil-muskoli u għadam
English: Such pain may be of sufficient intensity to warrant the shortterm prescription of opiate analgesics.
Maltese: Ġew irrappurtati reazzjonijiet ta' sensittività eċċessiva akuta nklużi anafilasi.
English: Feeling hot, injection site erythema, lethargy, malaise, oedema peripheral, pain, pitting oedema, temperature intolerance, weakness
Maltese: Mhux komuni: Sħanat, eritema fil-post tal-injezzjoni, ħass ħażin, edema periferali, uġigħ,
English: The majority of the SAEs experienced were gastrointestinal disorders (8% - 11 patients), specifically nausea (3% - 4 patients), vomiting (3% - 4 patients) and upper abdominal pain (2% - 2 patients).
Maltese: Fil-biċċa l-kbira, r-reazzjonijiet avversi li kienu serji li effettwaw ħdax il-pazjent, kienu problemi fis-sistema diġestiva (8% - 11 pazjenti), b'mod speċifiku d-dardir (3% - 4 pazjenti), rimettar (3% - 4 pazjenti), u uġigħ fin-naħa ta' fuq tal-addome (2% - 2 pazjenti).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use
Maltese: DETENTUR (I) TA' L-AWTORIZZAZZJONI TAL-MANIFATTURA RESPONSABBLI
English: Patients may receive a second laser light application 96-120 hours after administration.
Maltese: Il-pazjenti jistgħu jerġgħu jingħataw it-tieni illuminazzjoni bil-laser 96-120 siegħa wara li jkun ingħata PhotoBarr.
English: Women of child-bearing potential should use effective contraception before, during and for at least 90 days after treatment.
Maltese: Nisa li jistgħu jinqabdu tqal għandhom jużaw mezzi ta' kontraċezzjoni qabel, waqt u sa 90 jum wara ttrattament.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq jimpenja ruħu li jwettaq studju ta' reġistru u attivitajiet ta' farmakoviġilanza, skond il-Pjan ta' Farmakoviġilanza, kif miftehem fil-verżjoni 2 tal-Pjan ta' Ġestjoni dwar ir-Riskju (RMP) preżentata f'Modulu 1.8.2 tal-Applikazzjoni tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kull aġġornament sussegwenti tal-RMP miftiehem mis-CHMP.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali jingħata b'riċetta ristretta tat-tabib (Ara Anness I: Sommarju talKaratteristiċi tal-Prodott, sezzjoni 4.2)
English: Balloon Window Size (cm)
Maltese: Qis tal-kanal talbużżieqa (ċm)
English: a Whenever possible, the BO segment selected for treatment should include normal tissue margins of a few millimetres at the proximal and distal ends.
Maltese: 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.
English: There may be an increase in the risk of thrombo-embolic events especially in patients with prolonged immobilization, post major surgery and other thromboembolic risk factors.
Maltese: Jista' jkun hemm żieda fir-riskju ta' avvenimenti trombo-emboliċi aktar u aktar f'pazjenti b'immobilizzazjoni għal tul taż-żmien, fatturi ta' riskju ta' wara operazzjoni serja u fatturi oħra ta' riskju tromboemboliċi.
English: 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.
Maltese: Dawl ta' ġewwa:Evita l-espożizzjoni diretta ta' dawl luminanti ta' ġewwa, li jinkludu l-lampi taddentist, lampi li jintużaw għal interventi kiruġiċi, lampi mingħajr lqugħ u li toqgħod qrib ta' dawl tan-neon.
English: Lactation
Maltese: Manifattur
English: PhotoBarr should not be used in children and adolescents below 18 years of age, due to lack of experience.
Maltese: PhotoBarr m'għandux jintuża fi tfal u adoloxxenti li għandhom inqas minn 18-il sena, minħabba nuqqas ta' esperjenza.
English: Co-administration of omeprazole (20 mg BID) began at least 2 days before PhotoBarr injection.
Maltese: L-għoti flimkien ma' omerprazole (20 mg BID) beda tal-anqas jumejn qabel l-injezzjoni ta' PhotoBarr.
English: NAME OF THE MEDICINAL PRODUCT PhotoBarr 15 mg powder for solution for injection
Maltese: PhotoBarr 15 mg trab għal soluzzjoni għall-injezzjoni.
English: Very common side effects fever photosensitivity reactions (see section 3) vomiting, nausea tightening of the gullet (oesophagus), difficulty in swallowing that may cause pain constipation, dehydration
Maltese: Effetti sekondarji komuni ħafna - deni - reazzjonijiet ta' fotosensittività (ara sezzjoni 3) - remettar, tqalligħ - għafis fl-esofagu, diffikultà biex tibla li jista' jikkawża l-uġigħ, - stitikezza, deidrazzjoni.
English: 6.3 Shelf life
Maltese: 4. GĦAMLA
English: The survival curves indicated that, by the end of the entire follow-up period, patients in the PhotoBarr PDT + OM group had a 83% chance of being cancer-free as compared to a 53% chance for patients in the OM only group.
Maltese: Il-kurva ta' sopravivenza tindika li matul l-istudju kollhu, pazjenti li kienu fil-grupp PDT + OM kellhom 83% ċans li ma jiżviluppawx kanċer, meta mqabbla ma' 53% ċans fil-każ ta' pazjenti tal-grupp OM biss.
English: Fibre optic power outputs and treatment times required to deliver 130 J/cm of diffuser length using the centring balloon
Maltese: Rata ta' enerġija li toħroġ mid-diffużur tal-fibra ottika u tul ta' żmien tat-trattament meħtieġ biex iforni 130 J/ċm ta' tul ta'diffużur bil-bużżieqa li tiċċentra.
English: You should stop breast-feeding before using PhotoBarr.
Maltese: Għandek tieqaf tredda' qabel tibda tuża PhotoBarr.