FrancophonIA/ELRC3.0 huggingface dataset:
English: Some resistant isolates have been identified from avian Aspergillus fumigatus.
Maltese: Xi iżolati reżistenti ġew identifikati minn Aspergillus fumigatus avjarju.
English: In humans it is known that itraconazole can inhibit the metabolism of medicinal products that are substrates for cytochrome 3A isoenzymes, for example, chloramphenicol, ivermectin or methylprednisolone.
Maltese: Fil-bnedmin huwa magħruf li itraconazole jista' jinibixxi l-metaboliżmu ta' prodotti mediċinali li huma substrati għal isoenzimi taċ-ċitokromju 3A, pereżempju, chloramphenicol, ivermectin jew methylprednisolone.
English: Bottle (10 ml and 50 ml)
Maltese: Flixkun (10 ml u 50 ml)
English: 7255 LX Hengelo (Gld) THE NETHERLANDS.
Maltese: 7255 LX Hengelo (Gld) IL-PAJJIZI L-BAXXI.
English: <{MM/YYYY}>
Maltese: JIS {xahar/sena}
English: Psittaciformes (only):
Maltese: Psittaciformi (biss):
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Purified water.
Maltese: Hydrochloric acid (għall-aġġustament tal-pH) Sodium hydroxide (għall-aġġustament tal-pH)
English: Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives.
Maltese: Antimikotiċi għall-użu sistematiku, derivattivi ta' triazole.
English: Av. Herrmann-Debrouxlaan 17 B 1160 Oudergem- Brussels Tel.: 0032-27344899
Maltese: Herrmann-Debrouxlaan 17 B 1160 Oudergem-Brussell Tel .: 0032-27344899
English: THE NETHERLANDS
Maltese: L-Olanda
English: Candidiasis (Psittaciformes only):
Maltese: Kandidjasi (Psittaciformi biss):
English: Strigiformes (owls)
Maltese: Strigiformi (kokki)
English: Do not store above 25 °C.
Maltese: Taħżinx f'temperaturi ogħla minn 25 °C.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: Il-frekwenza ta' reazzjonijiiet avversi hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali trattat li juru reazzjoni(jiet) avversa(i)) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal trattat) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal trattat) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal trattat) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati trattat).
English: 7255 LX Hengelo (Gld) THE NETHERLANDS
Maltese: 7255 LX Hengelo (Gld) IL-PAJJIŻI L-BAXXI
English: Itraconazole elimination may be a saturable process.
Maltese: L-eliminazzjoni ta' itraconazole tista' tkun proċess saturabbli.
English: 5 to 10 mg (0.5 ml to 1 ml) itraconazole per kg bodyweight per day for 8 weeks.
Maltese: 5 sa 10 mg (0.5 ml sa 1 ml) ta' itraconazole għal kull kg tal-piż tal-ġisem kuljum għal 8 ġimgħat.
English: Not applicable.
Maltese: Ilma purifikat.
English: One metabolite, hydroxyitraconazole, has the same antifungal activity as the parent drug.
Maltese: Metabolit wieħed, hydroxyitraconazole, għandu l-istess attività antifungali bħall-mediċina ġenitur.
English: Lubichowska 126 83-200 Starogard Gdański Tel.: 0048-583523849
Maltese: Starogard Gdański Tel .: 0048-583523849
English: The 1 ml oral syringe has graduations for 0.05 ml solution (= 0.5 mg itraconazole).
Maltese: Is-siringa orali ta' 1 ml għandha gradwazzjonijiet għal soluzzjoni ta' 0.05 ml (= 0.5 mg ta' itraconazole).
English: Resistance to azole antifungals is most commonly exhibited by modification of the cyp51A gene which encodes for the target enzyme 14-alpha-sterol demethylase.
Maltese: Reżistenza għal antifungali azole hija l-aktar komunement esibita mill-modifika tal-ġene cyp51A li jikkodifika għall-enzima fil-mira 14-alpha-sterol demethylase.
English: The minimum inhibitory concentrations of itraconazole for different Aspergillus isolates in birds in Europe varies between 0.25 and >16 g/ml.
Maltese: Il-konċentrazzjonijiet minimi inibitorji ta' itraconazole għal iżolati differenti ta' Aspergillus fl-għasafar flEwropa jvarjaw bejn 0.25 u >16 g/ml.
English: Laboratory studies in pregnant rats administered high dosages (40 and 160 mg/kg bodyweight daily for 10 days) have shown evidence of dose-related harmful effects to the pregnant rat and to the embryo/foetus.
Maltese: Studji fil-laboratorji fuq firien tqal li ngħataw dożi għoljin (40 u 160 mg/kg piż tal-ġisem kuljum għal 10 ijiem) wrew evidenza ta' effetti ta' ħsara relatati mad-doża lill-far tqila u lill-embriju/fetu.
English: Aspergillosis:
Maltese: Asperġillożi:
English: Laboratory animal studies have shown that itraconazole used concomitantly with amphotericin B may be antagonistic against Aspergillus spp.
Maltese: Studji fl-annimali fil-laboratorju wrew li meta itraconazole jintuża flimkien ma' amphotericin B jista' jkun antagonistiku kontra Aspergillus spp.
English: Itraconazole inhibits the synthesis of ergosterol.
Maltese: Itraconazole jinibixxi s-sintesi ta' ergosterol.
English: 6-8 88326 Aulendorf Tel.: 0049-7525205-71
Maltese: Dechra Veterinary Products / Albrecht GmbH Veterinär-medizinische Erzeugnisse Hauptstr. 6-8 88326 Aulendorf Tel .: 0049-7525205-71
English: Anseriformes (specifically swans)
Maltese: Anseriformi (speċifikament ċinji)
English: None.
Maltese: Av.
English: Fungitraxx 10 mg/ml oral solution itraconazole
Maltese: Fungitraxx 10 mg/ml soluzzjoni orali itraconazole
English: Laboratory studies in rats have shown evidence of dose-related teratogenic, foetotoxic and maternotoxic effects at high dosages (40 and 160 mg/kg bodyweight administered daily for 10 days during their gestational period).
Maltese: Studji fil-laboratorju fil-firien urew evidenza ta' effetti teratoġeniċi, fetutoniċi u maternotoniċi relatati mad-doża f'dożaġġi għoljin (40 u 160 mg/kg piż tal-ġisem mgħotija kuljum għal 10 ijiem matul ilperjodu tat-tqala tagħhom).
English: Data were limited on the minimum inhibitory concentrations for different Candida isolates.
Maltese: Id-dejta dwar il-konċentrazzjonijiet minimi inibitorji għal iżolati differenti ta' Candida kienet limitata.
English: The 5 ml oral syringe has graduations for 0.2 ml solution (= 2 mg itraconazole).
Maltese: Is-siringa orali ta' 5 ml għandha gradwazzjonijiet għal soluzzjoni ta' 0.2 ml (= 2 mg ta' itraconazole).
English: Floris Veterinaire Produkten B.V. Kempenlandstraat 33
Maltese: Floris Veterinaire Produkten B.V.
English: Amounts to be administered:
Maltese: Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq:
English: 10 mg (1 ml) itraconazole per kg bodyweight per day for 14 days.
Maltese: 10 mg (1 ml) ta' itraconazole għal kull kg tal-piż tal-ġisem kuljum għal 14-il jum.
English: Accipitriformes (hawks)
Maltese: Pakkett (daqs)
English: Detailed information on this veterinary medicine is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini (http://www.ema.europa.eu/).
English: A graduated polypropylene oral syringe is also included.
Maltese: Polipropilene siringa orali gradwata hija inkluża wkoll.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar veterinarju dan il-prodott tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini (http://www.ema.europa.eu/).
English: Box containing 1 bottle of 50 ml with one 5 ml oral syringe.
Maltese: Kaxxa li fiha flixkun 1 ta' 50 ml b'siringa orali waħda ta' 5 ml.
English: Box containing 1 bottle of 10 ml with one 1 ml oral syringe.
Maltese: Kaxxa li fiha flixkun 1 ta' 10 ml b'siringa orali waħda ta' 1 ml.
English: Thurles, Co. Tipperary Tel.: 00353-50443169
Maltese: Tel .: 00353-50443169
English: The different target species consume different types of food and exhibit differing metabolism.
Maltese: L-ispeċi fil-mira differenti jikkunsmaw tipi differenti ta' ikel u juru metaboliżmu differenti.
English: Administration route:
Maltese: Deskrizzjoni:
English: Package sizes
Maltese: DAQS TAL-PAKKETT
English: Dechra Veterinary Products/Albrecht GmbH Veterinär-medizinische Erzeugnisse Hauptstr.
Maltese: Għalhekk l-għoti ta' dan il-prodott ma' prodotti mediċinali veterinarji oħra għandu jiġu evitat.
English: Because of its long half-life, itraconazole does not reach steady state plasma levels for at least 6 days after the start of treatment.
Maltese: Minħabba l-half-life twila tiegħu, itraconazole ma jilħaqx livelli stabbli fil-plasma għal mill-inqas 6 ijiem wara l-bidu tal-kura.
English: Cardboard box containing an amber glass (type III) bottle with a tamper-evident polypropylene screw cap and LDPE insert.
Maltese: Kaxxa tal-kartun li fiha flixkun tal-ħġieġ ambra (tat-tip III) b'tapp bil-kamin tal-polypropylene li ma jistax jinfetaħ mit-tfal u inserzjoni tal-LDPE.
English: Outer carton
Maltese: TIKKETTAR
English: If suspected lesions (such as the occurrence of cutaneous nodules or erythematous papules, respiratory symptoms such as coughing and wheezing) occur in humans, consult a physician.
Maltese: Jekk ikun hemm leżjonijiet suspettati (bħall-okkorrenza ta' noduli fil-ġilda jew bżieżaq żgħar eritematużi, sintomi respiratorji bħal sogħla u tħarħir) li jseħħu fil-bnedmin, ikkonsulta tabib.
English: For the treatment of African Grey Parrots (see section “Special warnings”) use no more than 5 mg (0.5 ml) itraconazole per kg bodyweight per day.
Maltese: Għall-kura ta' Pappagalli Griżi Afrikani (ara sezzjoni “Twissijiet speċjali”) uża mhux aktar minn 5 mg (0.5 ml) ta' itraconazole għal kull kg tal-piż tal-ġisem kuljum.
English: For the treatment of African Grey Parrots (see section 4.5) use no more than 5 mg (0.5 ml) itraconazole per kg bodyweight per day.
Maltese: Għall-kura ta' Pappagalli Griżi Afrikani (ara sezzjoni 4.5) uża mhux aktar minn 5 mg (0.5 ml) ta' itraconazole għal kull kg tal-piż tal-ġisem kuljum.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Maltese: Sustanza attiva:
English: For the treatment of African Grey Parrots use no more than 5 mg (0.5 ml) itraconazole per kg bodyweight per day for 14 days (see section “Special warnings”).
Maltese: Għall-kura ta' Pappagalli Griżi Afrikani uża mhux aktar minn 5 mg (0.5 ml) ta' itraconazole għal kull kg tal-piż tal-ġisem kuljum għal 14-il jum (ara sezzjoni “Twissijiet speċjali”).
English: Fungitraxx 10 mg/ml oral solution for ornamental birds itraconazole
Maltese: VETERINARJU Fungitraxx 10 mg/ml soluzzjoni orali għal għasafar ornamentali itraconazole
English: DD/MM/YYYY
Maltese: Il-Ġermanja
English: The concomitant use of the antibiotic erythromycin can result in an increased plasma concentration of itraconazole in the blood of the bird, which may result in increased adverse effects.
Maltese: L-użu konkomitanti tal-antibijotiku erythromycin jista' jwassal għal konċentrazzjoni ogħla ta' itraconazole fil-plasma fid-demm tal-għasfur, li jista' jwassal għal żieda fl-effetti avversi.
English: For the treatment of African Grey Parrots use no more than 5 mg (0.5 ml) itraconazole per kg bodyweight per day for 14 days (see section 4.5).
Maltese: Għall-kura ta' Pappagalli Griżi Afrikani uża mhux aktar minn 5 mg (0.5 ml) ta' itraconazole għal kull kg tal-piż tal-ġisem kuljum għal 14-il jum (ara sezzjoni 4.5).
English: Frequent and repeated use of antifungals from the same class may increase the risk of development of resistance to that class of antifungals.
Maltese: L-użu frekwenti u ripetut ta' antifungali mill-istess klassi jista' jżid ir-riskju li tiġi żviluppata reżistenza għal dik il-klassi ta' antifungali.
English: No information on overdose is currently available in the target species (see section 4.6.
Maltese: Ma hemm l-ebda informazzjoni dwar doża eċċessiva attwalment disponibbli fl-ispeċi fil-mira (ara sezzjoni 4.6.).
English: Dose and treatment schedule:
Maltese: Grupp farmako-terapewtiku:
English: Fungitraxx 10 mg/ml oral solution for ornamental birds
Maltese: VETERINARJU Fungitraxx 10 mg/ml soluzzjoni orali għal għasafar ornamentali
English: The mode of action of itraconazole is based on its highly selective binding ability for fungal cytochrome P-450 isoenzymes.
Maltese: Il-mod ta' azzjoni ta' itraconazole huwa bbażat fuq il-ħila selettiva ħafna ta' rbit tiegħu għall-iżoenzimi fungali taċ-ċitokromju P-450.
English: Although the relevance of this information for the target species is unknown, it would be prudent to avoid the concurrent use of such substances with this product because an increase and/or a prolongation of their pharmacological effects, including side effects, may occur.
Maltese: Għalkemm il-rilevanza ta' din l-informazzjoni għall-ispeċi fil-mira mhijiex magħrufa, ikun prudenti li jiġi evitat l-użu konkomitanti ta' dawn is-sustanzi ma' dan il-prodott minħabba li jista' jkun hemm żieda u/jew titwil tal-effetti farmakoloġiċi tagħhom, inklużi effetti sekondarji.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Maltese: Fin-nuqqas ta' studji dwar kompatibbiltà, dan il-prodott mediċinali veterinarju m'għandux jitħallat ma' prodotti mediċinali veterinarji oħra.
English: Tisseel/Tissucol and Artiss
Maltese: Tisseel/Tissucol u Artiss
English: Scientific Discussion
Maltese: Diskussjoni Xjentifika
English: Benefit Risk balance
Maltese: Bilanċ tal-Benefiċċju Riskju
English: The CHMP also concluded the Article 20 review on Evicel.
Maltese: Is-CHMP ikkonkluda wkoll ir-reviżjoni skont l-Artikolu 20 dwar Evicel.
English: Excessive pressure
Maltese: Pressjoni eċċessiva
English: Evicel was sprayed antero-laterally via pressure regulator with N2 (nitrogen) for a single two-second burst at approximately 2½ to 3 centimetres with reduced pressure of 8 (eight) PSI.
Maltese: Evicel kien sprejjat antero-lateralment permezz ta' regolatur tal-pressjoni b'N2 (nitroġenu) għal splużjoni unika ta' żewġ sekondi f'madwar 2½ sa 3 ċentimetri bi pressjoni mnaqqsa ta' 8 (tmien) PSI.
English: It is not recommended for use in laparoscopic surgery.
Maltese: Mhuwiex rakkomandat għall-użu f'kirurġija laparoskopika.
English: Tisseel/Tissucol use different pressure regulators for open surgery (pressurized air) and minimally invasive/laparoscopic procedures (pressurized CO2), respectively.
Maltese: Tisseel/Tissucol juża regolaturi tal-pressjoni differenti għal kirurġija miftuħa (arja taħt pressjoni) u għal proċeduri minimament invażivi/laparoskopiċi (CO2 taħt pressjoni), rispettivament.
English: Beriplast P, Tisseel, Tissucol and Artiss contain aprotinin, whereas Quixil contains tranexamic acid.
Maltese: Beriplast P, Tisseel, Tissucol u Artiss fihom aprotinin, filwaqt li Quixil fih l-aċidu traneksamiku.
English: Inappropriate distance from the tissue surface
Maltese: Distanza inadegwata mill-wiċċ tat-tessut
English: The CHMP agreed that the DHPC should be circulated to all users of those products in Europe, no later than 15 January 2013.
Maltese: Is-CHMP qabel li d-DHPC għandha tiġi ċirkolata lill-utenti kollha ta' dawk il-prodotti fl-Ewropa, sa mhux aktar tard mill-15 ta' Jannar 2013.
English: Despite risk mitigation activities put in place between August 2010 and early 2011 for Quixil and Evicel, including: 1) a direct healthcare professional communication regarding a change in product labelling, 2) field safety notification for the pressure regulator including change in the instructions for use, and 3) updated customer training programs, two new cases of air embolism (and a third case was received during the referral procedure) have been reported following use of the spray application of Evicel (one non-fatal case in August 2011 and a fatal case in January 2012).
Maltese: Minkejja attivitajiet ta' mitigazzjoni tar-riskju stabbiliti bejn Awwissu 2010 u kmieni fl-2011 għal Quixil u Evicel, inkluż: 1) komunikazzjoni diretta lill-professjonisti tal-kura tas-saħħa rigward tibdil fit-tikkettar tal-prodott, 2) notifika ta' sikurezza fuq il-post għar-regolatur tal-pressjoni inkluż tibdil fl-istruzzjonijiet għall-użu, u 3) programmi aġġornati ta' taħriġ għall-klijenti, żewġ każijiet ġodda ta' emboliżmu tal-ajru (u t-tielet każ kien riċevut matul il-proċedura ta' riferiment) kienu rrapportati wara l-użu tal-applikazzjoni ta' Evicel bħala sprej (każ wieħed mhux fatali f'Awwissu 2011 u każ fatali f'Jannar 2012).
English: In minimally invasive/laparoscopic procedures (Tisseel/Tissucol), only carbon dioxide gas should be used.
Maltese: Fi proċeduri minimament invażivi/laparoskopiċi (Tisseel/Tissucol), għandu jintuża biss iddijossidu tal-karbonju.
English: Tisseel and Tissucol differ in terms of Factor XIII content.
Maltese: Tisseel u Tissucol jvarjaw f'termini tal-kontenut tal-Fattur XIII.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC fibrinogencontaining solutions for sealant authorised for administration by spray application;
Maltese: • Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għal soluzzjonijiet li fihom fibrinoġen għal siġillanti awtorizzati għall-għoti b'applikazzjoni bħala sprej;
English: The CHMP reviewed all cases of gas embolism reported with the use of sprayable fibrin sealants (including the cases reported with Quixil and Evicel).
Maltese: Is-CHMP irreveda l-każijiet kollha ta' emboliżmu tal-gass irrapportati bl-użu ta' siġillanti tal-fibrina li jistgħu jiġu sprejjati (inkluż il-każijiet irrapportati bi Quixil u Evicel).
English: However, technical requirements when limiting spray application to CO2 gas were considered to add uncertainties to the clinical use of those products, e.g. in minimally invasive/laparoscopic surgery where the maximal pressure to be applied is 1.5 bar, the pressure regulator intended for open wound surgery that allows a higher pressure, could be used by mistake, or the handling associated with CO2 cylinders and respective pressure reducing connectors in the operating theatre.
Maltese: Madankollu, meta l-applikazzjoni bħala sprej tiġi limitata għal CO2 ġie kkunsidrat li r-rekwiżiti tekniċi jżidu inċertezzi mal-użu kliniku ta' dawk il-prodotti, eż. f'kirurġija minimament invażiva/laparoskopika fejn il-pressjoni massima li għandha tiġi applikata hija ta' 1.5 bar, ir-regolatur tal-pressjoni maħsub għal kirurġija fuq ferita miftuħa li jippermetti pressjoni ogħla, jista' jintuża bi żball, jew l-immaniġġjar assoċjat ma' ċilindri tas-CO2 u konnekters rispettivi li jnaqqsu l-pressjoni fit-teatru tal-operazzjoni.
English: Risk of air embolism associated with the spray application of fibrin sealants
Maltese: Riskju ta' emboliżmu tal-arja assoċjat mal-applikazzjoni ta' siġillanti tal-fibrina bħala sprej
English: The CHMP agreed on a Direct Healthcare Professional Communication (DHPC), to communicate the outcome of the present review.
Maltese: Is-CHMP qabel dwar Komunikazzjoni Diretta lill-Professjonali tal-Kura tas-Saħħa (DHPC), biex jikkomunika r-riżultat tar-reviżjoni attwali.
English: During the Article 31 procedure, the CHMP also noted a new case of gas embolism reported with the use of Evicel during laser prostatectomy.
Maltese: Matul il-proċedura skont l-Artikolu 31, is-CHMP innota wkoll każ ġdid ta' emboliżmu tal-gass irrapportat bl-użu ta' Evicel matul prostatektomija bil-laser.
English: Following this, the UK's Medicines and Healthcare products Regulatory Agency triggered a procedure under Article 31 on 24 May 2012, requesting the CHMP to carry out the same assessment for the other fibrin sealants available in the EU, i.e. Quixil, Tissucol, Tisseel, Artiss, Beriplast P, and associated names (see Annex I).
Maltese: Wara dan, lAġenzija Regolatorja tal-Mediċini u tal-prodotti għall-Kura tas-Saħħa tar-Renju Unit tat bidu għal proċedura skont l-Artikolu 31 fl-24 ta' Mejju 2012, fejn talbet lis-CHMP iwettaq l-istess evalwazzjoni għas-siġillanti l-oħra tal-fibrina disponibbli fl-UE, jiġifieri Quixil, Tissucol, Tisseel, Artiss, Beriplast P, u ismijiet assoċjati (ara Anness I).
English: Finally, Tisseel/Tissucol and Artiss should only be sprayed using a pressure regulator that caps the maximum pressure at 2.0 bar in open wound surgery and using a pressure regulator device that deliver a maximum pressure of 1.5 bar and carbon dioxide gas only in minimally invasive/laparoscopic procedures.
Maltese: Fl-aħħar nett, Tisseel/Tissucol u Artiss għandhom jiġu sprejjati biss b'regolatur tal-pressjoni li jillimita l-pressjoni massima għal 2.0 bar f'kirurġija fuq ferita miftuħa u permezz ta' apparat li jirregola l-pressjoni li jwassal pressjoni massima ta' 1.5 bar u dijossidu tal-karbonju biss fi proċeduri minimament invażivi/laparoskopiċi.
English: Artiss is indicated as a tissue glue to adhere/seal subcutaneous tissue in plastic, reconstructive and burn surgery, as a replacement or an adjunct to sutures or staples.
Maltese: Artiss huwa indikat bħala kolla għat-tessut biex iwaħħal/jissiġilla tessut subkutanju f'kirurġija plastika, rikostruttiva u fuq ħruq, bħala sostitut jew żieda ma' suturi jew stejpils.
English: CHMP considered restricting spray application of these products to CO2 gas only.
Maltese: Is-CHMP ikkunsidra li jirrestrinġi l-applikazzjoni ta' dawn il-prodotti bħala sprej għal CO2 biss.
English: Beriplast P is not sprayed using automated pressure regulator.
Maltese: Beriplast P ma jiġix sprejjat b'regolatur awtomatizzat tal-pressjoni.
English: On 15 November 2012, the CHMP concluded the review of Quixil (for which four cases of lifethreatening air embolism were reported) and agreed that the benefit-risk balance of Quixil as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis is positive under normal conditions of use, subject to changes to the product information and implementation of risk minimisation measures, including educational materials and training to be provided to users of the product.
Maltese: Fil-15 ta' Novembru 2012, is-CHMP ikkonkluda r-reviżjoni ta' Quixil (li għalih kienu rrapportati erba' każijiet ta' emboliżmu tal-arja ta' periklu għall-ħajja) u qabel li l-bilanċ tal-benefiċċju-riskju ta' Quixil bħala kura ta' appoġġ f'kirurġija fejn tekniki kirurġiċi standard mhumiex biżżejjed, għat-titjib tal-emostasi huwa pożittiv taħt kundizzjonijiet normali ta' użu, soġġett għal tibdil għall-fuljett ta'
English: Annex II Scientific conclusions and grounds for variation to the terms of the Marketing Authorisations
Maltese: Anness II Konklużjonijiet xjentifiċi u raġunijiet għal varjazzjoni tat-termini talAwtorizzazzjonijiet għat-Tqegħid fis-Suq
English: The patient underwent a surgical procedure for an unknown reason and Tisseel was reported to have been sprayed using the Easyspray pressure regulator to a ‘closure port' leading to an air embolism.
Maltese: Il-pazjent għadda minn proċedura kirurġika għal raġuni mhux magħrufa u Tisseel kien irrapportat li kien ġie sprejjat bir-regolatur tal-pressjoni Easyspray għal ‘closure port' li wassal għal emboliżmu tal-arja.
English: However the CHMP noted that to date, only one non-fatal case of air embolism has been reported for these products as compared to the 8 cases of air embolism (including 3 cases with fatal outcome) reported with Quixil and Evicel.
Maltese: Madankollu, is-CHMP innota li sal-lum, każ wieħed biss mhux fatali ta' emboliżmu tal-arja kien ġie rrapportat għal dawn il-prodotti meta mqabbel mat8 każijiet ta' emboliżmu tal-arja (inkluż 3 każijiet fatali) irrapportati bi Quixil u Evicel.