FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 ml OXERVATE solution in sterile, preservative-free multi-dose Type I glass vials, closed with a rubber stopper and an aluminium overseal with a polypropylene flip-off cap, presented in cardboard cartons.
Maltese: 1 ml soluzzjoni ta' OXERVATE f'kunjetti tal-ħġieġ sterili ta' Tip 1, mingħajr preservattivi, ta' ħafna dożi, magħluqin b'tapp tal-lastiku u b'siġill tal-aluminju b'għatu tal-polypropylene li jinqala' bissaba', ippreżentata f'kaxxa tal-kartun.
English: In case of concomitant use with contact lenses, see section 4.4.
Maltese: F'każ ta' użu fl-istess waqt b'lentijiet tal-kuntatt, ara sezzjoni 4.4.
English: OXERVATE is used to treat adults with moderate or severe ‘neurotrophic keratitis'.
Maltese: OXERVATE jintuża biex jittratta adulti b'‘keratite newrotrofika' moderata jew severa.
English: EMA/80652/2014 EMEA/H/C/00551
Maltese: EMEA/H/C/00551
English: EPAR summary for the public ziconotide
Maltese: Sommarju tal-EPAR għall-pubbliku ziconotide
English: The full EPAR for Prialt can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Prialt can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Prialt jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The starting dose of Prialt is 2.4 micrograms per day.
Maltese: Id-doża tal-bidu bi Prialt hija ta' 2.4 mikrogrammi kuljum.
English: The maximum dose is 21.6 micrograms per day.
Maltese: Id-doża massima hija ta' 21.6 mg kuljum.
English: The most common side effects with Prialt (seen in more than 1 patient in 10) are confusion, dizziness, nystagmus (uncontrolled eye movement), impaired memory (forgetfulness), headache, somnolence (sleepiness), blurred vision, nausea (feeling sick), vomiting, abnormal gait (difficulty walking) and asthenia (weakness).
Maltese: L-effetti sekondarji l-aktar komuni bi Prialt (li dehru f'aktar minn pazjent minn 10) huma konfużjoni, sturdament, nistagmus (moviment tal-għajnejn bla kontroll), memorja mdgħajfa (meta wieħed jinsa), uġigħ ta' ras, somnolenza (ngħas), viżjoni mċajpra, nawżja (tħossok ma tiflaħx), remettar, gawta abnormali (problemi fil-mixi) u astenja (dgħjufija).
English: This is a summary of the European public assessment report (EPAR) for Prialt.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Prialt.
English: Before treatment, patients with cancer or AIDS pain had an average VASPI score of 74 mm, and those with other types of pain had a score of 80 mm. After treatment, the scores in patients receiving Prialt decreased to 35 and 54 mm, respectively, while scores in patients receiving placebo were 61 and 72 mm.
Maltese: Wara t-trattament, il-livelli fil-pazjenti li jirċievu Prialt niżel sa 35 u 54 mm, rispettivament, filwaqt li livelli ta' pazjenti li jirċievu plaċebo kienu 61 u 72 mm.
English: In the third study, there was a trend for Prialt to be more effective than placebo, with the VASPI score changing from 81 mm before treatment to 68 mm in patients receiving Prialt and to 74 mm in patients receiving placebo.
Maltese: Fit-tielet studju, kien hemm tendenza li Prialt ikun aktar effikaċi minn plaċebo, b'livell ta' VASPI jinbidel minn 81 mm qabel it-trattament għal 68 mm f'pazjenti li jirċievu Prialt u għal 74 mm f'pazjenti li jirċievu plaċebo.
English: The active substance in Prialt, ziconotide, is a copy of a natural substance called omega-conopeptide, which is found in the venom of a type of sea snail.
Maltese: Is-sustanza attiva Prialt, ziconotide, hija kopja ta' sustanza naturali msejħa omega-conopeptide, li tinsab f'velenu ta' tip ta' għakruxu tal-baħar.
English: Prialt was originally authorised under ‘exceptional circumstances', because, as the disease is rare, limited information was available at the time of approval.
Maltese: Prialt kien oriġinarjament awtorizzat taħt “ċirkostanzi ta' eċċezzjoni”, għaliex, minħabba li l-marda hija rari, kien hemm informazzjoni limitata disponibbli fi żmien l-approvazzjoni.
English: What is Prialt?
Maltese: X'inhu Prialt?
English: Prialt is a solution for infusion that contains the active substance ziconotide.
Maltese: Prialt huwa soluzzjoni għall-infużjoni li fih is-sustanza attiva ziconotide.
English: How has Prialt been studied?
Maltese: Kif ġie studjat Prialt?
English: A risk management plan has been developed to ensure that Prialt is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jassigura li Prialt jintuża bl-aktar mod sigur possibbli.
English: What is the risk associated with Prialt?
Maltese: X'riskji huma assoċjati ma' Prialt?
English: This is a score given by the patients of their pain on a scale from 0 mm (no pain) to 100 mm (maximum pain).
Maltese: Dan huwa livell mogħti mill-pazjenti ta' wġigħ fuq skala minn 0 mm (bla wġigħ) sa 100 mm (uġigħ massimu).
English: Prialt has been compared with placebo (a dummy treatment) in 589 patients with severe long-term pain in three main studies.
Maltese: Prialt ġie mqabbel ma' plaċebo (trattament finta) f'589 pazjent b'uġigħ sever fuq żmien twil fi tliet studji prinċipali.
English: What benefit has Prialt shown during the studies?
Maltese: Liema benefiċċji wera Prialt waqt l-istudji mwettqa?
English: Because the number of patients who have long-term pain that requires painkillers to be injected directly into the spine is low, the disease is considered ‘rare', and Prialt was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 July 2001.
Maltese: Minħabba li n-numru ta' pazjenti li għandhom uġigħ għal żmien twil li jeħtieġ mediċina kontra l-uġigħ injettata direttament fix-xewka tad-dahar huwa baxx, il-marda hija kkunsidrata ‘rari', u Prialt ġie klassifikat bħala ‘mediċina orfni' (mediċina użata għal mard rari) fid-9 ta' Lulju 2001.
English: What measures are being taken to ensure the safe and effective use of Prialt?
Maltese: X'miżuri qegħdin jittieħdu biex jassiguraw użu sigur u effettiv ta' Prialt?
English: Most patients need doses lower than 9.6 micrograms per day.
Maltese: Il-biċċa l-kbira tal-pazjenti jeħtieġu dożi anqas minn 9.6 mikrogrammi kuljum.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that Prialt provides an alternative to other intrathecal painkillers, such as opioids.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li Prialt jipprovdi alternattiva għal mediċina oħra intratekali kontra l-uġigħ, bħall-opjojdi.
English: Prialt must be given as a very slow continuous infusion through an intrathecal catheter (a tube inserted into the spinal canal) using an infusion pump capable of delivering an accurate amount of the medicine.
Maltese: Prialt għandu jingħata bħala infużjoni kontinwa u bil-mod permezz ta' kateter intratekali (tubu mdaħħal fil-kanal tax-xewka tad-dahar) bl-użu ta' pompa ta' infużjoni kapaċi li tagħti ammont preċiż talmediċina.
English: Ziconotide acts by blocking special pores called calcium channels on the surface of the nerve cells that transmit the pain signals.
Maltese: Ziconotide jaġixxi billi jimblokka pori speċjali msejħa kanali tal-kalċju fuq il-wiċċ taċ-ċelluli nervużi li jittrażmettu sinjali tal-uġigħ.
English: Why has Prialt been approved?
Maltese: Għaliex ġie approvat Prialt?
English: Prialt must not be used in patients at the same time as intrathecal chemotherapy (medicines to treat cancer that are injected into the spinal canal).
Maltese: Prialt ma għandux jintuża f'pazjenti fl-istess żmien mal-kimoterapija intratekali (mediċini li jittrattaw ilkanċer li jiġu injettati fil-kanal tax-xewka tad-dahar).
English: By blocking the flow of calcium into the nerve cells, ziconotide interferes with the transmission of pain signals within the spine.
Maltese: Billi jimblokka l-fluss talkalċju fiċ-ċelloli nervużi, ziconotide jinterferixxi mat-trażmissjoni ta' sinjali tal-uġigħ fix-xewka taddahar.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Prialt on 21 February 2005..
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fuq is-suq valida fl-Unjoni Ewropea kollha għal Prialt fil-21 ta' Frar 2005.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 17 January 2014.
Maltese: Billi l-kumpanija pprovdiet it-tagħrif addizzjonali mitlub, iċ-‘ċirkostanzi ta' eċċezzjoni' ntemmu fis-17 ta' Jannar 2014.
English: Other information about Prialt
Maltese: Aktar tagħrif dwar Prialt
English: Treatment with Prialt should only be carried out by a doctor who has experience in the intrathecal dosing of medicines.
Maltese: Trattament bi Prialt għandu jsir biss minn tabib li għandu esperjenza f'dożaġġ ta' mediċini intratekali.
English: In all of the studies, the main measure of effectiveness was the change in the Visual Analog Scale of Pain Intensity (VASPI).
Maltese: Fl-istudji kollha, il-kejl ewlieni tal-effikaċja kienet il-bidla fil-Visual Analog Scale ta' Intensità tal-Uġigħ (VASPI).
English: How is Prialt used?
Maltese: Kif jaħdem Prialt?
English: For the full list of all side effects and restrictions with Prialt, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u rrestrizzjonijiet kollha bi Prialt, ara l-fuljett ta' tagħrif.
English: London, 23 April 2009 Doc.
Maltese: Londra, 23 ta' April 2009 Dok. ta' Ref.
English: Ref. EMEA/196121/2009
Maltese: EMEA/316927/2009
English: International non-proprietary name (INN): ixabepilone
Maltese: Isem internazzjonali komuni (INN): ixabepilone
English: What is Ixempra?
Maltese: Ixempra?
English: On 18 March 2009, Bristol-Myers Squibb Pharma EEIG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ixempra, for the treatment of locally advanced or metastatic breast cancer.
Maltese: Fit-18 ta' Marzu 2009, Bristol-Myers Squibb Pharma EEIG innotifikat uffiċjalment lill-Kumitat għallProdotti Mediċinali għall-Użu mill-Bniedem (CHMP) li hija tixtieq tirtira l-applikazzjoni tagħha għallawtorizzazzjoni għat-tqegħid fis-suq għal Ixempra, għall-kura tal-kanċer tas-sider lokalment avvanzat jew metastatiku.
English: The other two studies compared the effects of capecitabine given on its own with the effects of Ixempra given in combination with capecitabine in a total of 1,973 women.
Maltese: Iż-żewġ studji l-oħra qabblu l-effetti ta' capecitabine mogħti waħdu mal-effetti ta' Ixempra mogħti flimkien ma' capecitabine f'total ta' 1,973 mara.
English: The first study looked at Ixempra given on its own in 128 women, but did not compare it with any other treatment.
Maltese: L-ewwel studju ħares lejn Ixempra mogħti waħdu f'128 mara, iżda ma qabblux ma' xi kura oħra.
English: The active substance in Ixempra, ixabepilone, is a cytotoxic medicine that belongs to a group of medicines called the ‘epothilones'.
Maltese: Is-sustanza attiva f'Ixempra, ixabepilone, hija mediċina ċitotossika li tappartjeni għal grupp ta' mediċini msejħa ‘epotiloni'.
English: Ixabepilone is expected to block the ability of cells to modify the internal ‘skeleton' that they need to divide and multiply.
Maltese: Ixabepilone huwa mistenni li jimblokka l-kapaċità taċ-ċelloli li jimmodifikaw l-‘iskeletru' intern li jeħtieġu sabiex jinqasmu u jimmultiplikaw.
English: It was to be used in combination with capecitabine (another anticancer medicine) when previous treatment with cytotoxic medicines (medicines that kill cells that are dividing, such as cancer cells) had failed.
Maltese: Kellu jintuża flimkien ma' capecitabine (mediċina oħra ta' kontra l-kanċer) meta tkun kura preċedenti b'mediċini ċitotossiċi (mediċini li joqtlu ċ-ċelloli li qegħdin jinqasmu, bħaċ-ċelloli tal-kanċer) ma tkunx ħadmet.
English: What was Ixempra expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża
English: The effects of Ixempra were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Ixempra għall-ewwel ġew ittestjati f'mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: Ixabepilone is also expected to affect non-cancer cells such as nerve cells, which could cause side effects.
Maltese: Ixabepilone huwa mistenni wkoll li jaffettwa ċelloli li mhumiex tal-kanċer bħal ċelloli tan-nervituri, li jista' jikkawża effetti sekondarji.
English: The CHMP had given a negative opinion and did not recommend a marketing authorisation for Ixempra for the treatment of locally advanced or metastatic breast cancer.
Maltese: Il-CHMP kien ħareġ opinjoni negattiva u ma rrakkomandax awtorizzazzjoni għat-tqegħid fis-suq għal Ixempra għall-kura ta' kanċer tas-sider lokalment avvanzat jew metastatiku.
English: What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes using Ixempra?
Maltese: X'dokumentazzjoni ppreżentat il-kumpanija biex tappoġġa l-applikazzjoni tagħha lis-CHMP?
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Ixempra and that patients receiving Ixempra as part of a compassionate use programme will continue to receive the medicine.
Maltese: Il-kumpanija għarrfet lis-CHMP li ma kienx hemm konsegwenzi għall-pazjenti li jkunu għaddejjin minn provi kliniċi b'Ixempra u li pazjenti li qegħdin jirċievu Ixempra bħala parti minn programm ta' użu b'kumpassjoni sejrin ikomplu jirċievu l-mediċina.
English: Ixempra is a medicine that contains the active substance ixabepilone.
Maltese: X'kien it-tħassib ewlieni tas-CHMP?
English: OTHER GE Healthcare
Maltese: GE Healthcare
English: GE Medical Systems Polska Sp. z o.o.
Maltese: GE Medical Systems Polska Sp. z o.o. Woloska
English: GR-15125 MΑΡΟΥΣΙ
Maltese: GR - 15125
English: Date of latest renewal: 12 June 2008
Maltese: Data tal-aħħar tiġdid: 12 ta'Ġunju 2008
English: 5 x 3 ml presentation: EU/1/98/065/002
Maltese: preżentazzjoni 5 x 3 ml: EU/1/98/065/002
English: GE Healthcare AS Nycoveien 1, NO-0485 Oslo, Norway
Maltese: GE Healthcare AS, Nycoveien 1, 0485 Oslo, In-Norveġja
English: Woloska St. 9
Maltese: St. 9
English: GE International Inc. Meza 4
Maltese: GE International Inc.
English: • Warm sensation
Maltese: • Sensazzjoni ta' sħana
English: H-2040 BUDAÖRS Tel. + 36 23 410 412
Maltese: BUDAÖRS Tel. + 36 23 410 412
English: Hypersensitivity has been reported.
Maltese: Ġiet irrapportata sensittività eċċessiva.
English: M.G.P.
Maltese: M.G.P. spol.
English: Store upright in a refrigerator (2°C - 8°C).
Maltese: Aħżen wieqaf fil-friġġ (2°C - 8°C).
English: SI-2000 Maribor Tel: + 386 2 4716300
Maltese: Maribor Tel: + 386 2 4716300
English: OPTISON could be repeatedly administered, however, the clinical experience is limited.
Maltese: OPTISON jista' jerġa' jingħata ripetutament, iżda l-esperjenza klinika hija limitata.
English: N-acetyltryptophan Caprylic acid
Maltese: Human albumin Sodium chloride N-acetyltryptophan Caprylic acid
English: Excipient with known effect: Each ml contains 0.15 mmol (3.45 mg) of sodium.
Maltese: Kull ml fih 0.15 mmol (3.45 mg) ta' sodium.
English: GE Healthcare Buchler GmbH & Co. KG Gieselweg 1
Maltese: GE Healthcare Buchler GmbH & Co.
English: NO-0485 Oslo Tlf: + 47 23 18 50 50
Maltese: Oslo Tlf: + 47 23 18 50 50
English: Store upright in a refrigerator (2oC - 8ºC).
Maltese: Aħżen f'pożizzjoni vertikali fi friġġ (2oC - 8ºC).
English: Adverse reactions to OPTISON are rare and usually of a non-serious nature.
Maltese: Reazzjonijiet avversi ta' OPTISON huma rari u normalment ma jkunux serji.
English: Side effects to OPTISON are rare and usually not serious.
Maltese: L-effetti sekondarji għal OPTISON huma rari u normalment ma jkunux serji.
English: What OPTISON contains - The active substance is perflutren-containing microspheres of heat treated human albumin 58 x 108/ml, suspended in human albumin solution 1%.
Maltese: X'fih OPTISON - Is-sustanza attiva tikkonsisti f'mikrosferi li fihom perflutren ta' albumina umana ttrattata bis sħana 5-8 x 108/ml, bħala sospensjoni f'soluzzjoni ta' albumina umana 1%.
English: Before administering OPTISON, please see section 6.6 for instructions for use/handling.
Maltese: Qabel ma jingħata OPTISON, jekk jogħġbok ara sezzjoni 6.6 għal istruzzjonijiet ta' użu/immaniġġjar.
English: C/Gobelas, 35-37
Maltese: GE Healthcare Bio-Sciences, S.A.U. C/ Gobelas, 35-37
English: Rare side effects (affects 1 to 10 users in 10,000):
Maltese: Effetti sekondarji rari (jaffettwaw minn utent 1 sa 10 utenti minn kull 10,000):
English: MARKETING AUTHORISATION NUMBERS 1 x 3 ml presentation: EU/1/98/065/001
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ preżentazzjoni 1 x 3 ml: EU/1/98/065/001
English: PHARMACEUTICAL FORM Dispersion for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Dispersjoni għall-injezzjoni.
English: The effect of OPTISON on pulmonary haemodynamics was studied in a prospective, open-label study of 30 patients scheduled for pulmonary artery catheterisation, including 19 with an elevated baseline pulmonary arterial systolic pressure (PASP) (>35 mmHg; mean 70.1±33.0 mmHg; range 36.0-176.0
Maltese: L-effetti ta' OPTISON fuq l-emodinamika pulmonari ġew studjati fi studju prospettiv bit-tikketta mikxufa, fuq 30 pazjent skedati għal katiterizzazzjoni tal-arterja pulmonari, li fosthom 19 kellhom pressjoni sistolika arterjali pulmonari tal-linja bażi għolja (PASP) (>35 mmHg; medja 70.1±33.0 mmHg; medda 36.0-176.0 mmHg) u 11 kellhom PASP normali (≤35 mmHg; medja 29.
English: Reported side effects following the use of OPTISON:
Maltese: Effetti sekondarji li ġew irrapporati wara l-użu ta' OPTISON:
English: Sodium hydroxide (pH adjustment) Water for injections
Maltese: Sodium hydroxide (aġġustament tal-pH)
English: Josipa Marohnića 1
Maltese: KG Gieselweg 1
English: GE Healthcare SAS 22/24, avenue de l'Europe F-78-140 Velizy Villacoublay Tél: + 33 1 34 49 54 54
Maltese: GE Healthcare SAS 22/24, avenue de l'Europe F-78-140
English: Concentration: Perflutren-containing microspheres, 5-8 x 108/ml with a mean diameter range of 2.54.5 µm.
Maltese: Konċentrazzjoni: mikrosferi li fihom Perflutren, 5-8 x 108/ml b'medja ta' dijametru fil-limiti ta' bejn 2.5 u 4.5 µm.
English: • Paraesthesia (tingling sensations)
Maltese: • Sturdament • Parestesija (sensazzjoni ta' tnemnim)
English: Visual disturbances
Maltese: Disturbi fil-vista
English: NAME OF THE MEDICINAL PRODUCT OPTISON 0.19 mg/ml dispersion for injection
Maltese: OPTISON 0.19 mg/ml dispersjoni għal injezzjoni
English: Systemic haemodynamic parameters and ECGs were also evaluated.
Maltese: Il-parametri emodinamiċi sistemiċi u l-ECGs ġew evalwati wkoll.
English: LIST OF EXCIPIENTS Excipients: Human albumin, sodium chloride, N-acetyltryptophan, caprylic acid, sodium hydroxide and water for injections.
Maltese: Eċċipjenti: Soluzzjoni tal-albumina tal-bniedem, sodium chloride, N-acetyltryptophan, caprylic acid,
English: Such clinical states include adult respiratory distress syndrome, the use of artificial respiration with positive end-expiratory pressure, severe heart failure (NYHA IV), endocarditis, acute myocardial infarction with on-going angina or unstable angina, hearts with prosthetic valves, acute states of systemic inflammation or sepsis, known states of hyperactive coagulation system and/or recurrent thromboembolism, renal or hepatic end-stage disease.
Maltese: Dawn is-sitwazzjonijiet kliniċi jinkludu s-sindromu ta' distress respiratorju fl-adulti, l-użu ta' respirazzjoni artifiċjali bi pressjoni pożittiva wara li joħroġ in-nifs, insuffiċjenza severa tal-qalb (NYHA IV), endokardite, infart mijokardijaku akut b'anġina kontinwa jew anġina instabbli, qlub b'valvoli prostetiċi, kondizzjonijiet akuti ta' infjammazzjoni sistemika jew sepsis, kondizzjonijiet magħrufa tas-sistema tal-koagulazzjoni iperattiva u/jew tromboëmboliżmu rikorrenti, mard tal-aħħar fażi fil-kliewi jew fil-fwied.
English: Your heart activity and rhythm will be monitored when you get OPTISON.
Maltese: L-attività u r-ritmu ta' qalbek sejrin jiġu mmonitorjati meta tingħata OPTISON.
English: OPTISON contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Maltese: OPTISON fih inqas minn 1 mmol ta' sodium (23 mg) f'kull doża, jiġifieri huwa essenzjalment ‘ħieles mis-sodium'.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/065/001 EU/1/98/065/002 13.
Maltese: EU/1/98/065/001 EU/1/98/065/002
English: Dysgeusia (altered taste), headache Tinnitus, dizziness, paraesthesia
Maltese: Tinnite, sturdament, paraestesija
English: - if you have severe pulmonary hypertension (systolic pulmonary artery pressure > 90 mm Hg).
Maltese: - jekk għandek ipertensjoni qawwija fil-pulmun (pressjoni sistolika tal-arterja tal-pulmun > 90 mm Hg).
English: OPTISON consists of perflutren-containing microspheres of heat treated human albumin, suspended in human albumin solution, 1%.
Maltese: OPTISON jikkonsisti f'mikrosferi tal-albumina umana ittrattati bis-sħana li fihom perflutren, jgħumu f'soluzzjoni ta' albumina tal-bniedem, 1%.
English: Ventricular tachycardia
Maltese: Takikardja ventrikulari
English: Common side effects (affects 1 to 10 users in 100):
Maltese: Effetti sekondarji komuni (jaffettwaw minn utent 1 sa 10 minn kull 100):
English: - Use the suspension within 30 minutes after withdrawal.
Maltese: - Uża s-suspensjoni fi żmien 30 minuta minn meta tinġibed.
English: OPTISON consists of perflutren -containing microspheres.
Maltese: OPTISON jikkonsisti f'mikrosferi li fihom perflutren.
English: High levels of radioactivity were also retained in lungs for a considerable time, approx. 10% of the total dose 40 minutes after dose administration (cf. 35% in liver).
Maltese: Il-pulmuni wkoll żammew livelli għoljin ta' radjuattività għal żmien mhux ħażin, bejn wieħed u ieħor 10% tad-doża totali 40 minuta wara li ngħatat id-doża (cf. 35% fil-fwied).
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c (7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 May 1998
Maltese: Data tal-ewwel awtorizzazzjoni: 18 ta'Mejju 1998
English: BE-1831 Diegem België/Belgique/Belgien Tél/Tel: + 32 (0) 2 719 73 11
Maltese: BE-1831 Diegem België/Belgique/Belgien
English: In two uncontrolled studies including a total of 42 children and adolescents, aged 8 months to 19 years, the safety profile appeared to be similar to that seen in adults.
Maltese: F'żewġ studji mhux ikkontrollati li kienu jinkludu total ta' 42 tifel/tifla u adoloxxenti, ta' età bejn 8 xhur u 19-il sena, il-profil ta' sigurtà deher li huwa simili għal dak li deher fl-adulti.
English: - Inject the suspension through the plastic cannula, no smaller than 20 G at a maximum injection rate of 1.0 ml/s.
Maltese: - Injetta s-suspensjoni permezz tal-kannula tal-plastik, li ma tkunx iżgħar minn 20 G b'rata massima ta' injezzjoni ta' 1.0 ml/s.
English: The duration of the useful imaging time is 2.5 - 4.5 minutes for a dose of 0.5 - 3.0 ml.
Maltese: It-tul ta' żmien li jkun hemm bżonn għall-viżjoni huwa ta' 2.5 - 4.5 minuti għal doża ta' 0.5 - 3.0 ml.
English: Pharmacotherapeutic group: Ultrasound contrast medium, ATC Code: V08D A01
Maltese: Mezz għall-kuntrast fl-ultrasawnd, Kodiċi ATC: