FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Entacapone Teva on 18 February 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Entacapone Teva valida fl-Unjoni Ewropea kollha fit-18 ta' Frar 2011.
English: The CHMP concluded that, in accordance with EU requirements, Entacapone Teva has been shown to have comparable quality and to be bioequivalent to Comtess.
Maltese: Is-CHMP ikkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, intwera li l-kwalità ta' Entacapone Teva hija komparabbli u bijoekwivalenti għal dik ta' Comtess.
English: Entacapone blocks an enzyme that is involved in the breakdown of levodopa in the body called catechol-O-methyl transferase (COMT).
Maltese: L-entakapon timblokka l-enżima li hija involuta fit-tkissir tal-levodopa fil-ġisem imsejħa katekol-O-metiltransferażi (COMT).
English: The active substance in Entacapone Teva, entacapone, works to restore the levels of dopamine in the parts of the brain that control movement and co-ordination.
Maltese: Is-sustanza attiva f'Entacapone Teva, lentakapon, taħdem billi ġġib lura l-livelli normali tad-dopamina fil-partijiet tal-moħħ li jikkontrollaw ilmoviment u l-koordinazzjoni.
English: Because Entacapone Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Ġaladarba Entacapone Teva huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, jitqies li l-benefiċċji u r-riskji huma l-istess bħal dawk tal-mediċina ta' referenza.
English: Because Entacapone Teva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Comtess.
Maltese: Peress li Entacapone Teva huwa mediċina ġenerika, l-istudji fuq in-nies ġew limitati għal testijiet li jiddeterminaw jekk din il-mediċina hix bijoekwivalenti għall-mediċina ta' referenza Comtess.
English: This means that Entacapone Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Comtess.
Maltese: Dan ifisser li Entacapone Teva huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Comtess.
English: Entacapone Teva is a medicine that contains the active substance entacapone.
Maltese: Entacapone Teva huwa mediċina li fih is-sustanza attiva entakapon.
English: What are the benefits and risks of Entacapone Teva?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Entacapone Teva?
English: As a result, levodopa remains active for longer.
Maltese: Minħabba dan illevodopa tibqa' attiva tul iżjed żmien.
English: What is Entacapone Teva?
Maltese: Kif jintuża Entacapone Teva?
English: Why has Entacapone Teva been approved?
Maltese: Għaliex ġie approvat Entacapone Teva?
English: Entacapone Teva is used together with levodopa (either a combination of levodopa and benserazide or a combination of levodopa and carbidopa) when the patient is having ‘fluctuations' towards the end of the period between two doses of their medication.
Maltese: Entacapone Teva jintuża flimkien mal-levodopa (jew mal-levodopa u l-benserażide jew mal-levodopa u l-karbidopa) meta l-pazjenti jkollhom ‘fluttwazzjonijiet' lejn l-aħħar tal-perjodu bejn żewġ dożi talmedikazzjoni tagħhom.
English: Entacapone Teva can only be used with conventional combinations of levodopa.
Maltese: Entacapone Teva jista' jintuża flimkien ma' taħlitiet konvenzjonali tal-levodopa.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Maltese: Żewġ mediċini jkunu bijoekwivalenti meta jipproduċu l-istess livelli tas-sustanza attiva tagħhom fil-ġisem.
English: Fluctuations happen when the effects of the medication wear off and symptoms re-emerge.
Maltese: Il-fluttwazzjonijiet jiġru meta l-effetti tal-mediċina ma jibqgħux jinħassu u ssintomi jfeġġu mill-ġdid.
English: In patients with Parkinson's disease, the cells in the brain that produce the neurotransmitter dopamine begin to die and the amount of dopamine in the brain decreases.
Maltese: Din tgħin sabiex jittejbu s-sintomi tal-marda ta' Parkinson's, bħalma huma l-ebusija fil-muskoli u d-dewmien fiċ-ċaqliq.
English: Entacapone Teva is only used in combination either with levodopa and benserazide or with levodopa and carbidopa.
Maltese: Għaldaqstant il-fehma tas-CHMP kienet li, sewwasew bħal Comtess, il-benefiċċji huma akbar mir-riskji identifikati.
English: Other information about Entacapone Teva
Maltese: Entacapone Teva
English: 20 October 2015 EMA/498568/2015
Maltese: EMA/498568/2015
English: Caraway fruit EMA/498568/2015
Maltese: Frotta tal-karwija EMA/828089/2015
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 ta' Ottubru 2015
English: Caraway fruit medicines must not be used in patients who are hypersensitive (allergic) to caraway fruit or other plants of the Apiaceae (Umbelliferae) family (fennel, anise, celery, coriander and dill), to mugwort or birch.
Maltese: Il-mediċini li fihom il-frotta tal-karwija ma għandhomx jintużaw f'pazjenti li jkunu ipersensittivi (allerġiċi) għall-frotta tal-karwija jew għal pjanti oħrajn tal-familja Apiaceae (Umbelliferae) (bużbież, aniż, karfus, kosbor u xibt), il-mugwort jew il-betula.
English: Caraway fruit
Maltese: Frotta tal-karwija
English: Caraway fruit medicines should only be used in adults and adolescents over the age of 12 years.
Maltese: Il-mediċini li fihom il-frotta tal-karwija għandhom jintużaw biss f'adulti u adolexxenti li għandhom iktar minn 12-il sena.
English: What are the risks associated with caraway fruit medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini li fihom il-frotta tal-karwija?
English: What are the HMPC conclusions on its medicinal uses?
Maltese: X'inhuma l-konklużjonijiet tal-HMPC dwar l-użijiet mediċinali tagħha?
English: Further information on the risks associated with caraway fruit medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati mal-mediċini li fihom il-frotta tal-karwija, inklużi lprekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografu taħt it-tab ‘Id-dokumenti kollha' fis-sit web tal-Aġenzija:
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of caraway fruit.
Maltese: Dan id-dokument huwa sommarju tal-konklużjonijiet xjentifiċi li wasal għalihom il-Kumitat għallProdotti Mediċinali Erbali (HMPC) dwar l-użijiet mediċinali tal-frotta tal-karwija.
English: Further information on the HMPC assessment of caraway fruit medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC noted the lack of clinical studies on the effects of caraway fruit in patients, but took into account the well documented use of this herbal medicine for the above-mentioned use.
Maltese: L-HMPC innota n-nuqqas ta' studji kliniċi dwar l-effetti tal-frotta tal-karwija fil-pazjenti, iżda kkunsidra l-użu ddokumentat sew ta' din il-mediċina erbali għall-użu msemmi hawn fuq.
English: Other information about caraway fruit medicines
Maltese: Aktar informazzjoni dwar il-mediċini li fihom il-frotta tal-karwija
English: Date of latest renewal: 4 March 2009
Maltese: Data tal-aħħar reviżjoni: 4 ta' Marzu 2009
English: Manufacturer Axcan Pharma SAS, Route de Bû, 78550 Houdan, France
Maltese: Manifattur Axcan Pharma SAS, Route de Bû, 78550 Houdan, Franza
English: Orlyplein 10, 1043 DP Amsterdam The Netherlands
Maltese: Orlyplein 10, 1043 DP Amsterdam l-Olanda
English: PhotoBarr Injection
Maltese: Injezzjoni PhotoBarr
English: PhotoBarr is neither a primary ocular irritant nor a primary dermal irritant.
Maltese: PhotoBarr la huwa irritant okulari primarju u lanqas irritant dermali.
English: The active substance is porfimer sodium.
Maltese: - Is-sustanza attiva hi porfimer sodium.
English: Powder: 3 years.
Maltese: Trab: 3 snin
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/272/002
Maltese: EU/1/04/272/001
English: The mean elimination half-life (t1/2) was 21.5 days (CV 26 %, range 264-672) in patients and 17 days in volunteers.
Maltese: Il-half-life ta' eliminazzjoni medja (t1/2) kienet ta' 21.5 ijiem (CV 26 %, medda 264-672) f'pazjenti u 17-il jum wara f'voluntieri.
English: Laser light
Maltese: Dawl laser
English: 3, 5 or 7 cm balloon (130 J/cm)
Maltese: Bużżieqa ta' 3, 5 jew 7 ċm (130 J/ċm)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 March 2004
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI /TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 25 ta' Marzu 2004
English: Thrombo-embolism
Maltese: Trombo-emboliżmu
English: Pinnacle Biologics B.V., p/a Trust Company Amsterdam B.V., Crystal Tower 21st Floor, Orlyplein 10, 1043 DP Amsterdam, The Netherlands
Maltese: Pinnacle Biologics B.V., p/a Trust Company Amsterdam B.V., Crystal Tower 21st Floor, Orlyplein 10, 1043 DP Amsterdam, l-Olanda
English: Subsequent free radical reactions can form superoxide and hydroxyl radicals.
Maltese: Sussegwentement reazzjonijiet tar-radikali jipproduċu superoxide u hydroxyl.
English: Oesophageal Stenosis
Maltese: Stenożi Esofagali
English: Musculoskeletal and connective tissue disorders Common:
Maltese: Disturbi muskolu-skeltrali u tal-connective tissue Komuni:
English: For a full list of excipients, see 6.1.
Maltese: Għal-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: Frequencies are defined as: very common (>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma mfissra hekk: komuni ħafna (>1/10); komuni (>1/100, <1/10); mhux komuni (>1/1000, <1/100); mhux magħrufa (ma jistgħux jiġu stimati mid-dejta disponibbli).
English: How does photodynamic therapy (PDT) work?
Maltese: Kif taħdem it-terapija fotodinamika (PDT)?
English: Light Intensity (mW/cm)
Maltese: Intensità tad-dawl (mW/ċm)
English: Porphyria.
Maltese: Porfirja
English: Fifty-two percent of patients in the PDT + OM group showed normal squamous cell epithelium while 59% had absence of dysplasia compared to 7% and 14% in the OM alone group, respectively (p<0.0001).
Maltese: 0001). 52% tal-pazjenti fil-grupp PDT + OM, urew li kellhom iċ-ċelluli tal-epitelju normali, filwaqt li 59% ma kellhomx displasja, meta mqabbla ma' 7% u 14% fil-grupp ta' OM biss (p<0.0001).
English: Reconstituted PhotoBarr solution (ml) = Patient's weight (kg) x 2 mg/kg = 0.8 x patient's weight
Maltese: Soluzzjoni ta' PhotoBarr rikostitwita (ml) = Piż tal-ġisem tal-pazjent (kg)x2 mg/kg = 0.8xpiż tal-ġisem 2.5 mg/ml
English: Angina pectoris, atrial fibrillation, atrial flutter, chest discomfort Vascular disorders
Maltese: Angina pectoris, fibrillazzjoni atrijali, tħabbit irregolari fl-arterji, skonfort fissider
English: Metabolism and nutrition disorders Very common: Dehydration* Common:
Maltese: Disturbi fil--metabolismu u n-nutrizzjoni Komuni ħafna: Deidratazzjoni* Komuni:
English: * see section c.
Maltese: * ara sezzjoni ċ.
English: Table 4.
Maltese: TABELLA 4.
English: 4.6 Fertility, Pregnancy and lactation
Maltese: .6 Fertilità, Tqala u Treddigħ
English: The most frequently reported treatment-associated serious adverse reaction (SAR) was dehydration (4%), experienced by 5 patients.
Maltese: Minn dawn, l-aktar komuni kienu deidratazzjoni (4%), li effettwat 5 pazjenti.
English: affects 1 to 10 users in 1,000
Maltese: li jaffettwaw aktar minn 1 sa 10 utenti fkull 1,000
English: Adverse reactions reported are listed below in Table 5 by organ class and frequency.
Maltese: F'Tabella 5 hemm lista ta' reazzjonijiet avversi li huma klassifikati skond il-frekwenza u organu li effettwat.
English: Treatment time (sec)
Maltese: Tul tat-trattament (sec)
English: In patients,the mean peak plasma concentration (Cmax) was 79.6 μg/ml (C.V. 61%, range 39-222), whereas in volunteers Cmax was 40 μg/ml and AUCinf was 2400 μg/h/ml.
Maltese: Fil-pazjenti, il-medja tal-ogħla konċentrazzjoni fil-plażma (Cmax) kienet ta' 79.6 μg/ml (C.V. 61%, medda ta' 39-222), filwaqt li tal-voluntieri Cmax kien ta' 40 μg/ml u AUCinf kien ta' 2400 μg/ml.
English: Chemical and physical in-use stability has been demonstrated for 3 hours at 23°C.
Maltese: Stabbilità kimika u fiżika tal-prodott għall-użu ġiet murija għal 3 sigħat f' temperatura ta' 23°C.
English: 75 mg powder in a vial (glass type I, 40 ml capacity) with a grey butyl stopper.
Maltese: 75 mg trab f'kunjetti (ħġieġ tip I, jesa' 40 ml) b'tapp griż tal-butyl.
English: 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%).
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: 15 mg powder in a vial (glass type I, 7 ml capacity) with a grey butyl stopper.
Maltese: 15 mg trab f'kunjett (ħġieġ tip I, jesa' 7 ml) b'tapp griż tal-butyl.
English: In patients, the mean peak plasma concentration (Cmax) was 79.6 μg/ml (CV 61%, range 39-222), whereas in volunteers Cmax was 40 μg/ml and AUCinf was 2400 μg/h/ml.
Maltese: Fil-pazjenti,il-medja ta' l-ogħla konċentrazzjoni fil-plażma (Cmax) kienet ta' 79.6 μg/ml (CV 61%, medda ta' 39-222), filwaqt li tal-voluntieri Cmax kien ta' 40 μg/ml u AUCinf kien ta' 2400 μg/ml..
English: Pharmacotherapeutic group: Sensitizers used in photodynamic/radiation therapy, ATC code: L01XD01
Maltese: Sensitizzaturi użati għal terapija fotodinamika/radjazzjoni, Kodiċi ATC:
English: Leukocytosis
Maltese: FARMAĊEWTIKU
English: Table 2 provides the settings that would be used to deliver the dose within the shortest time (light intensity of 270 mW/cm).
Maltese: Tabella 2 turi l-aġġustamenti biex tingħata doża fl-anqas ħin (b'intensità tad-dawl ta' 270 mW/ċm).
English: The second stage of therapy is illumination with laser light 40-50 hours following injection with PhotoBarr.
Maltese: It-tieni parti tat-terapija tinbeda 40-50 siegħa wara l-injezzjoni ta' Photobarr.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/272/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/272/001
English: PhotoBarr 15 mg vial should be reconstituted with 6.6 ml of 5% glucose solution for injection resulting in a final porfimer sodium concentration of 2.5 mg/ml in the solution for injection.
Maltese: Il-kunjett ta' 15 mg ta' PhotoBarr għandu jiġi rikostitwit b'6.6 ml ta' 5% glucose ta' infużjoni intravenuża, għal konċentrazzjoni finali ta' 2.5 mg/ml ta' porfimer sodium għal soluzzjoni għallinjezzjoni.
English: The proportion of patients who progressed to cancer in the PhotoBarr PDT + OM group was statistically lower than in the OM only group (p=0.0060).
Maltese: Il-proporzjon ta' pazjenti li żviluppaw kanċer fil-grupp PhotoBarr PDT + OM kien statistikament aktar baxx mill-grupp li użaw OM biss (p=0.0060).
English: Keep this leaflet.
Maltese: Jum ta' studju
English: Pulmonary or cardiac disorders
Maltese: Disturbi pulmonari jew kardijaċi
English: Each vial contains 15 mg of porfimer sodium.
Maltese: Kull kunjett fih 15 mg porfimer sodium.
English: You may receive a second laser light treatment 96-120 hours after the initial injection of PhotoBarr.
Maltese: Għandek mnejn tirċievi trattament ieħor bid-dawl laser 96-120 siegħa wara l-injezzjoni inizjali ta' PhotoBarr.
English: HOW TO STORE PHOTOBARR
Maltese: QABEL MA TUŻA PHOTOBARR
English: Treatment Time (min:sec)
Maltese: Tul tat-trattament (min:sec)
English: Each vial contains 75 mg of porfimer sodium.
Maltese: Kull kunjett fih 75 mg porfimer sodium.
English: Of the serious adverse events (SAEs) in the PhotoBarr PDT + OM group, 44 (23.1%) were considered associated with the treatment.
Maltese: 44 suġġett (23.1%) tal-grupp PhotoBarr PDT + OM kellhom reazzjonijiet avversi serji li ġew assoċjati mat-trattament.
English: Study day Light delivery Devices Treatment intent
Maltese: Kif intenzjonat it-trattament
English: Summary of adverse reactions with porfimer sodium Infections and infestations
Maltese: Sommarju ta' reazzjonijiet mhux mixtieqa b'porfimer sodium Infezzjonijiet u infestazzjonijiet
English: The light dose (J/cm)= power output from diffuser (W) x treatment time (sec)
Maltese: Id-doża tad-dawl (J/ċm)= Rata ta' enerġija li toħroġ mid-diffużur (W) x żmien tat-trattament (sec) Tul tad-diffużur (ċm)
English: PhotoBarr 75 mg vial should be reconstituted with 31.8 ml of 5% glucose solution for injection, resulting in a final porfimer sodium concentration of 2.5 mg/ml in the solution for injection.
Maltese: Il-kunjett ta' 75 mg ta' PhotoBarr għandu jiġi rikostitwit b'31.8 ml ta' 5% glucoseta' infużjoni intravenuża, għal konċentrazzjoni finali ta' 2.5 mg/ml ta' porfimer sodium għal soluzzjoni għallinjezzjoni.
English: In a controlled clinical trial, a PhotoBarr PDT + OM (omeprazole) patient group (n=183)was compared to a group of patients receiving OM only (n=70).
Maltese: Fi prova klinika kkontrollata, grupp ta' pazjenti li kienu fuq PhotoBarr PDT + OM (n=183) ġew mqabbla ma' grupp ta' pazjenti li kienu ngħataw OM biss (n=70).
English: Porfimer sodium is cleared slowly from the body, with a mean CLT of 0.859 ml/h/kg (C.V. 53%) in patients.
Maltese: Porfimer sodium jitneħħa bil-mod mill-ġisem b'rata medja CLT ta' 0.859 ml/h/kg (CV 53%) f'pazjenti.
English: 78550 Houdan
Maltese: Axcan Pharma SAS Route de Bû 78550 Houdan Franza
English: The first laser light session occurred 40-50 hours after injection and a second session, if indicated, occurred 96-120 hours after injection.
Maltese: Lewwel sessjoni bid-dawl laser saret 40-50 siegħa wara l-injezzjoni u tieni sessjoni, jekk dan ġie indikat saret wara 96-120 siegħa.
English: Tracheo-oesophageal fistula, Gastrointestinal necrosis Skin and subcutaneous tissue disorders
Maltese: Fistula trakeo-esofogali, Nekrożi gastro-intestinali
English: 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.
Maltese: 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 issensittività eċċessiva għad-dawl.
English: The other ingredients are hydrochloric acid and sodium hydroxide (for pH adjustment).
Maltese: 3. LISTA TA' SUSTANZI MHUX ATTIVI Hydrochloric acid, sodium hydroxide (għal aġġustament ta' pH).
English: Short (< 2.5 cm) fibre optic diffuser (50 J/cm)
Maltese: Diffużur qasir (≤ 2.5 ċm) tal-fibra ottika (50
English: Direct sunlight:
Maltese: Xemx diretta:
English: Elderly
Maltese: Kataretti
English: Photodynamic therapy (PDT) with PhotoBarr is indicated for ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO).
Maltese: Terapija fotodinamika (PDT) permezz ta' PhotoBarr hija intiża għal asportazzjoni ta' displasja qawwija (HGD) f'pazjenti li għandhom Esofagu ta' Barrett (BO).
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropeja dwar il-Mediċini (EMA) http://www.ema.europa.eu
English: Diffuser length (cm)
Maltese: Tul talapparat (ċm)
English: PhotoBarr PDT regularly causes dysphagia, odynophagia, nausea and vomiting.
Maltese: It-terapija fotodinamika b'PhotoBarr regolarment tikkaġuna disfaġja, odinofaġja, dardir, u rimettar.
English: With light activation, porfimer sodium was mutagenic in some in-vitro tests.
Maltese: B'attivazzjoni bid-dawl, porfimer sodium wera li huwa mutaġeniku f'ċerti testijiet tal-laboratorju in vitro.
English: Patients who received one course of PDT had a greater risk of progression to cancer than patients who received two or three courses of PDT (50% vs. 39% and 11% respectively)
Maltese: 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).
English: Tracheo-oesophageal or broncho-oesophageal fistula.
Maltese: Fistula fit-trakea-esofagali jew bronko-esofagali.
English: Pleural effusion, pharyngitis, atelectasis, dyspnoea
Maltese: Mhux komuni: Sturdament, ipoesteżija, rogħda
English: In vitro binding of porfimer sodium to human serum protein is around 90% and independent of concentration between 20 and 100 μg/ml.
Maltese: Madwar 90% ta' porfimer sodium jeħel in vitro ma' proteini tas-serum fil-ġisem tal-bniedem, b' mod indipendenti mill-konċentrazzjoni ta' bejn 20 u 100 μg/ml.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 15 mg porfimer sodium.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kunjett fih 15 mg trab ta' porfimer sodium.
English: At final analysis, performed at a minimum of 24 months follow-up, a statistically significant percentage of patients (77%) in the PhotoBarr PDT + OM group demonstrated complete HGD ablation compared to 39% of patients in the OM alone group (p<0.0001).
Maltese: Il-perċentwal ta' pazjenti li tfejqu għal kollox minn HGD kien statistikament sinifikanti (77%) fil-grupp ta' PhotoBarr PDT + OM, meta mqabbel ma' riżultat miksub ta' 39% mill-grupp ta' OM biss (p<0.
English: Very common: Oesophageal stenosis acquired*, vomiting*, dysphagia, constipation,
Maltese: Komuni ħafna: Stenożi akkwistata tal-esofagu*, rimettar*, disfaġja, stitikezza, dardir* Komuni:
English: The pharmacokinetics of porfimer sodium have been studied in 12 patients with endobronchial cancer and 23 healthy subjects (11 men and 12 women), given 2 mg/kg porfimer sodium through slow intravenous injection.
Maltese: Studju farmakokinetiku sar fuq 12-il pazjent li kellhom kanċer fil-bronki u 23 individwu b'saħħtu (11il rael u 12-il mara) li ngħataw 2 mg/kg portimer sodium b'injezzjoni ġol-vina bil-mod. Kampjuni talplażma ttieħdu sa 56 jum (pazjenti) jew 36 jum (voluntieri) wara l-injezzjoni.
English: The laser treatment induces a photochemical, not a thermal, effect.
Maltese: It-trattament bil-laser jikkaġuna effett fotokemikali mhux termali.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial 75 mg - 40 ml
Maltese: Ż-ŻGĦAR EWLENIN Kunjett 75 mg - 40 ml
English: PhotoBarr injection: You will receive one intravenous injection of PhotoBarr (2 mg per kg of body weight) 40 to 50 hours before laser light treatment.
Maltese: Għandek tirċievi injezzjoni waħda ġol-vina ta' PhotoBarr (2 mg għal kull kg ta' piż tal-ġisem) bejn 40 sa 50 siegħa qabel trattament bid-dawl laser.
English: 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.
Maltese: Eżempji ta' sustanzi bħal dawn huma dimethyl sulphoxide, b-carotene, ethanol, formate u mannitol.