FrancophonIA/ELRC3.0 huggingface dataset:
English: Date of first authorisation: 20 September 2006 Date of latest renewal: 15 July 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' Settembru 2006 Data tal-aħħar tiġdid: 15 ta' Lulju 2016
English: Millmount Healthcare Limited Block 7, City North Business Campus Stamullen, Co. Meath K32 YD60 Ireland
Maltese: Millmount Healthcare Limited Block 7, City North Business Campus Stamullen, Co. Meath K32 YD60
English: • and abnormal electrocardiogram.
Maltese: • u elettrokardjogramma anormali.
English: Lantheus EU Limited Rocktwist House, Block 1, Western Business Park Shannon, Co. Clare V14 FW97 Ireland
Maltese: Lantheus EU Limited Rocktwist House, Block 1, Western Business Park Shannon, Co. Clare V14 FW97 L-Irlanda
English: Luminity contains propylene glycol.
Maltese: Luminity fih propylene glycol.
English: Sodium Content
Maltese: Kontenut ta' Sodium
English: Headache, flushing.
Maltese: Uġigħ ta' ras, fwawar.
English: This medicine contains 103.5 mg/ml propylene glycol, which is equivalent to 182.2mg in each vial.
Maltese: Din il-mediċina fiha 103.5 mg/ml propylene glycol, ekwivalenti għal 182.2 mg f'kull kunjett.
English: Not known: Cardiac arrest, ventricular arrhythmias (ventricular fibrillation, ventricular tachycardia, premature ventricular contactions), asystole, atrial fibrillation, cardiac ischaemia, supraventricular tachycardia, supraventricular arrhythmia
Maltese: Bradikardija, Takikardija, Palpitazzjonijiet Mhux magħruf:Arrest kardijaku, arritmiji ventrikulari (fibrillazzjoni ventrikulari, takikardija ventrikulari, kontrazzjonijiet ventrikulari premature), asistolija, fibrillazzjoni atrijali, iskemja kardijaka, takikardja supraventrikulari, arritmija supraventrikulari
English: Pulmonary disease
Maltese: Mard pulmonari
English: All lipids are metabolised to free fatty acids.
Maltese: Il-lipidi kollha jiġu metabolizzati f'aċidi grassi liberi.
English: The time to maximum Doppler signal intensity tmax was shown to be similar to the perflutren blood tmax (1.13 versus 1.77 minutes).
Maltese: Il-ħin sa l-intensità massima tassinjal Doppler tmas instab li kien simili għat- tmas tad-demm għal perflutren (1.13 kontra 1.77 minuti).
English: Excipient(s) with known effect Each ml contains 2.679 mg sodium
Maltese: Kull ml fih 2.679 mg ta' sodium
English: Pharmacotherapeutic group: ultrasound contrast media, microspheres of phospholipids, ATC Code: V08DA04
Maltese: Kategorija farmakoterapewtika: mezzi ta' kuntrast ta' l-ultrasound, mikrosferi fosfolipidi, Kodiċi ATC:
English: Pack sizes of 1 or 4 vials.
Maltese: Daqsijiet tal-pakkett ta' 1 jew 4 kunjetti.
English: Other medicines and Luminity
Maltese: Mediċini oħra u Luminity
English: • and abnormal vision.
Maltese: • u vista mhux normali.
English: The pharmacokinetics and metabolism of MPEG5000 DPPE have not been evaluated in humans.
Maltese: Il-farmakokinetika u l-metaboliżmu ta' MPEG5000
English: • fatigue,
Maltese: • Sturdament,
English: Fundamental and non-linear imaging techniques (second harmonic, multipulse phase and/or amplitude modulation) using both continuous and triggered acquisition were utilised in clinical studies with Luminity.
Maltese: Intużaw tekniki ta' immaġni fundamentali u mhux lineari (second harmonic, multipulse phase u/jew amplitude modulation) bl-użu ta' ksib kontinwu jew imqabbad fi studji kliniċi b'Luminity.
English: Pharmacokinetics in special population groups
Maltese: Farmakokinetiċi fi gruppi ta' popolazzjonijiet speċjali
English: The most frequently reported adverse reactions are: headache (2.0%), flushing (1.0%) and back pain (0.9%).
Maltese: L-aktar reazzjonijiet avversi rrapportati ta' sikwit huma: uġigħ ta' ras (2.0%), fwawar (1.0%) u wġigħ fid-dahar (0.9%).
English: Luminity is an ultrasound contrast agent that contains microspheres (tiny bubbles) of perflutren gas as the active substance.
Maltese: Luminity huwa sustanza ta' kuntrast użat f'ultrasound li fiha mikrosferi żgħar (bżieżaq żgħar) tal-gass perflutren bħala s-sustanza attiva.
English: The observed 99% drop in Doppler signal intensity within 10 minutes (t1/2 approximately 2 minutes) was in agreement with the decline in measurable blood levels of perflutren.
Maltese: It tnaqqis osservat ta' 99% fl-intensità tas-sinjal Doppler f'għaxar minuti (t1/2 madwar 2 minuti) kien jaqbel mat-tnaqqis fil-livelli mkejla ta' perflutren fid-demm.
English: Luminity 150 microlitres/ml gas and solvent for dispersion for injection/infusion perflutren
Maltese: Luminity 150 mikrolitri/ml gass u solvent biex jinxtered għall-injezzjoni/infużjoni perflutren
English: BATCH NUMBER<, DONATION AND PRODUCT CODES>
Maltese: NUMRU TAL-LOTT<, DONAZZJONI U KODIĊI
English: Adverse reactions were reported with the following frequencies (Very common ≥ 1/10; Common ≥ 1/100 to < 1/10; Uncommon ≥ 1/1,000 to < 1/100; Rare ≥ 1/10,000 to < 1/1,000; Very rare < 1/10,000), not known (cannot be estimated from the available data).
Maltese: Reazzjonijiet avversi kienu rrappurtati bil-frekwenzi li ġejjin (Komuni ħafna ≥ 1/10; Komuni ≥ 1/100 sa < 1/10;
English: Patients on mechanical ventilation
Maltese: Pazjenti fuq ventilazzjoni mekkanika
English: Do not store the vial above 30°C following activation.
Maltese: 30°C wara l-attivazzjoni.
English: EU/1/06/361/001 4 single-dose vials EU/1/06/361/002 1 single-dose vial
Maltese: EU/1/06/361/002 kunjett wieħed ta' doża waħda
English: • feeling faint,
Maltese: • telf tas-sensi,
English: United Kingdom
Maltese: L-Irlanda
English: How to store Luminity
Maltese: Tużax Luminity
English: The approximate amount of perflutren gas in each ml of Luminity is 150 microlitres.
Maltese: L-ammont approssimattiv ta' gass ta' perflutren f'kull ml ta' Luminity huwa 150 mikrolitri.
English: Each ml contains maximum 6.4 x 109 perflutren-containing lipid microspheres with a mean diameter range of 1.1-2.5 μm (approximately 150 microlitres perflutren gas per ml).
Maltese: Kull ml fih massimu ta' 6.4 x 109 mikrosferi lipidi li fihom perflutren li d-dijametru medju tagħhom huwa 1.1-2.5 μm (bejn wieħed u ieħor 150 mikrolitri ta' gass ta' perflutren għal kull ml).
English: Luminity 150 microlitres/ml gas and solvent for dispersion for injection/infusion
Maltese: TAL-PRODOTT MEDIĊINALI Luminity 150 mikrolitri/ml gass u solvent li jinxtered għall-injezzjoni/infużjoni
English: Bolus intravenous injection using fundamental imaging technique at rest:
Maltese: Injezzjoni ta' bolus ġol-vina bl-użu ta' teknika ta' immaġni fundamentali waqt il-mistrieħ:
English: Rare: Arthralgia, flank pain, neck pain, muscle cramp Not known: Muscle spasm, musculoskeletal pain, musculoskeletal discomfort, myalgia, hypertonia
Maltese: Spażmi fil-muskoli, uġigħ muskoluskeletriku, skumdità muskoluskeletali, uġigħ fil-muskoli, ipertonija
English: Uncommon: Dyspnoea, Throat Irritation
Maltese: Mhux komuni: Dispneja, Irritazzjoni fil-ġerżuma
English: The approximate amount of perflutren gas in each ml is 150 microlitres (μl).
Maltese: 150 mikrolitri (μl).
English: • Dizziness,
Maltese: • għeja,
English: Fertility Animal studies do not indicate direct or indirect harmful effects on fertility.
Maltese: Studji f'annimali ma jurux effetti ħżiena diretti jew indiretti fuq il-fertilità.
English: Pregnancy
Maltese: ipoksja
English: These effects were observed at exposure levels in excess of the maximum human exposure indicating little relevance to clinical use.
Maltese: Dawn l-effetti ġew osservati f'livelli ta' espożizzjoni ogħla mill-espożizzjoni massima umana, u dan jindika ftit li xejn rilevanza għall-użu kliniku.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis sezzjoni 6.1.
English: Patients with adult respiratory distress syndrome, endocarditis, prosthetic heart valves, systemic inflammation, sepsis, hyperactive coagulation and/or recurrent thromboembolism Luminity should be used only after careful consideration and such use should be monitored closely during administration in patients with adult respiratory distress syndrome, endocarditis, a heart with prosthetic valves, acute states of systemic inflammation or sepsis, known states of hyperactive coagulation and/or recurrent thromboembolism.
Maltese: Pazjenti bis-sindrome ta' għeja respiratorja, endokardite, valvi prostetiċi tal-qalb, infjammazzjoni sistemika, sepsis, koagulazzjoni iperattiva u/jew tromboemboliżmu rikorrrenti Luminity għandu jintuża biss wara konsiderazzjoni b'attenzjoni, u dan l-użu għandu jiġi mmonitorjat mill-qrib waqt l-għoti f'pazjenti bis-sindrome ta' problemi respiratorji fl-adulti, endokardite, qalb b'valvoli prostetiċi, stati akuti ta' infjammazzjoni sistemika jew sepsis, stati magħrufa ta' koagulazzjoni iperattiva u/jew tromboemboliżmu rikorrenti.
English: Excipients: 1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC), 1,2-dipalmitoyl-sn-glycero-3-phosphatidic acid, monosodium salt (DPPA), N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE), sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride, propylene glycol, glycerol, water for injections
Maltese: Sustanzi mhux attivi: 1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC), 1,2-dipalmitoyl-sn-glycero-3-phosphatidic acid, monosodium salt (DPPA), N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE), sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride, propylene glycol, glycerol, ilma għall-injezzjonijiet
English: Gas and solvent for dispersion for injection/infusion 1 x 1.5 ml single-dose vial 4 x 1.5 ml single-dose vials
Maltese: U KONTENUT Gass u solvent biex jinxtered għall-injezzjoni/infużjoni 1 x kunjett ta' doża waħda ta' 1.5 ml 4 x kunjetti ta' doża waħda ta' 1.5 ml
English: The product consists of lipid encapsulated perflutren microspheres.
Maltese: Il-prodott huwa magħmul minn mikrosferi ta' perflutren inkapsulati fil-lipidi.
English: Each ml contains a maximum of 6.4 x 109 perflutren-containing lipid microspheres, with a mean diameter range of 1.1-2.5 micrometres (μm).
Maltese: Kull ml fih massimu ta' 6.4 x 109 mikrosferi lipidi li fihom perflutren, b'dijametru medju li jvarja bejn 1.1-2.5 mikrometri (μm).
English: • itching,
Maltese: • ħakk,
English: The reported adverse reactions following the use of Luminity in pivotal and supportive trials (total of 2,526 patients) occur within minutes after administration and usually resolve without therapeutic intervention within 15 minutes.
Maltese: Ir-reazzjonijiet avversi rrapportati wara l-użu ta' Luminity fi provi prinċipali u ta' sostenn (total ta' 2,526 pazjent) iseħħu fi żmien ftit minuti wara li jingħata u ġeneralment jitilqu mingħajr intervent terapewtiku fi żmien 15-il minuta.
English: The recommended dose via an intravenous infusion is 1.3 ml dispersion added to 50 ml of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection.
Maltese: Id-doża rakkomandata permezz ta' infużjoni ġol-vina hija ta' 1.3 ml dispersjoni miżjuda ma' 50 ml ta' soluzzjoni ta' 9 mg/ml (0.9%) ta' sodium chloride jew ta' 50 mg/ml (5%) ta' glukosju għal injezzjoni.
English: - The other ingredients are 1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC), 1,2dipalmitoyl-sn-glycero-3-phosphatidic acid, monosodium salt (DPPA), N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE), sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride, propylene glycol, glycerol and water for injections.
Maltese: L-ingredjenti l-oħra huma 1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC), 1,2-dipalmitoylsn-glycero-3-phosphatidic acid, monosodium salt (DPPA), N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE), sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride, propylene glycol, glycerol u ilma għall-injezzjonijiet.
English: - The dispersion should be withdrawn from the vial using a syringe with a 18 to 20 gauge sterile needle or attached to a sterile non-siliconised mini-spike.
Maltese: - Id-dispersjoni għandha tinġibed mill-kunjett billi tintuża labra sterilizzata b'kejl ta' 18 sa 20 jew imqabbda ma' mini-spike sterilizzat mhux silikonizzat.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: The Vialmix will alert the operator if the shaking frequency varies by 5% or more below the target frequency.
Maltese: IlVialmix għandu jinforma lill-operatur jekk il-frekwenza tat-taħwid tvarja b'5% jew aktar taħt ilfrekwenza fil-mira.
English: Doppler ultrasound measurements were performed with Luminity in conjunction with the pharmacokinetic evaluation of perflutren.
Maltese: Twettaq kejl b'ultrasound Doppler b'Luminity flimkien mal-valutazzjoni farmakokinetika ta' perflutren.
English: The product can be re-activated up to 48 hours after initial activation and used up to 12 hours after the second activation.
Maltese: Il-prodott jista' jerġa' jiġi attivat sa 48 siegħa wara l-attivazzjoni inizjali u jintuża sa 12-il siegħa wara t-tieni attivazzjoni.
English: The pharmacokinetic properties of Luminity were evaluated in normal healthy subjects and subjects with chronic obstructive pulmonary disease (COPD) following intravenous administration of a 50 µl/kg dose of the product.
Maltese: It-tagħrif farmakokinetiku ta' Luminity ġie evalwat f'suġġetti normali b'saħħithom u f'suġġetti b'mard kroniku ta' imblokk tal-pulmun (COPD - chronic obstructive pulmonary disease) wara li ngħatat doża ta' 50 µl/kg tal-prodott ġol-vina.
English: Rats treated with Luminity for 1 month exhibited dose-related, reversible perivascular and peribronchiolar eosinophil infiltration, alveolar macrophage accumulation and increased goblet cell size and number in the lungs.
Maltese: Il-firien ikkurati b'Luminity għal xahar urew infiltrazzjoni eosinofilika perivaskulari u peribronkjali riversibbli, relatata mad-doża, akkumulazzjoni ta' makrofagi alveolari u daqs u numru akbar ta' ċelloli goblet fil-pulmun.
English: CLlung was found to be significantly reduced (51%) in females compared to males (all subjects).
Maltese: Instab li CLpulmun kienet notevolment inqas (51%) fin-nisa meta mqabbel ma' l-irġiel
English: Luminity should only be administered by trained physicians with technical expertise in performing and interpreting contrast echocardiograms, and appropriate resuscitation equipment should be available in case of cardiopulmonary or hypersensitivity reactions (see section 4.4).
Maltese: sensittività eċċessiva għandu jkun hemm apparat ta' risuxxitazzjoni disponibbli (ara sezzjoni 4.4).
English: Single doses of up to 100 microlitres dispersion/kg and multiple doses up to 150 microlitres dispersion/kg were tolerated well in Phase I clinical trials.
Maltese: Dożi singoli ta' taħlita li fiha sa 100 mikrolitru għal kull kg u dożi multipli ta' taħlit li fihom sa 150 mikrolitru għal kull kg kienu ttollerati sewwa fil-provi kliniċi ta' l-Ewwel Fażi.
English: Patients with unstable cardiopulmonary status should be monitored during and for at least 30 minutes following Luminity administration.
Maltese: Pazjenti bi stat kardjopulmonari instabbli għandhom jiġu mmonitorjati matul u għal mill-inqas 30 minuta wara l-għoti ta' Luminity.
English: The recommended dose is 10 microlitre dispersion/kg by slow bolus intravenous injection, followed by a 10 ml bolus of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection.
Maltese: Id-doża rakkomandata hija taħlita ta' 10 mikrolitri/kg b'injezzjoni tal-bolus bil-mod ġol-vina, segwita b'10 ml ta' bolus ta' soluzzjoni ta' 9 mg/ml (0.9%) ta' sodium chloride jew ta' 50 mg/ml (5%) ta'
English: Uncommon: Pruritus, increased sweating Rare: Rash, urticaria, erythema, erythematous rash
Maltese: Mhux komuni: Uġigħ Addominali, Dijarea, Dardir, Rimettar,
English: • eye swelling,
Maltese: • togħma mibdula,
English: Extreme caution should be used when considering the administration of Luminity to patients with unstable cardiopulmonary status, for example: unstable angina, acute myocardial infarction, severe ventricular arrhythmias, severe heart failure (NYHA IV) or respiratory failure.
Maltese: Għandha tintuża kawtela estrema meta tikkunsidra l għoti ta' Luminity lil pazjenti bi stat kardjopulmonari instabbli, per eżempju: anġina instabbli, infart mijokardijaku akut, arritmiji ventrikulari severi, insuffiċjenza severa tal-qalb (NYHA IV) jew insuffiċjenza tan-nifs.
English: • abdominal pain, diarrhoea, nausea (feeling sick), vomiting,
Maltese: • uġigħ addominali, dijarea, nawsja (tħossok marid/a), rimettar,
English: Each ml contains a maximum of 6.4 x 109 perflutren-containing lipid bubbles, with an average diameter range of 1.1-2.5 micrometres.
Maltese: Kull ml fih massimu ta' 6.4 x 109 bżieżaq lipidi li fihom perflutren, b'dijametru li jvarja bejn 1.1 u 2.5 mikrometri.
English: - Luminity may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection.
Maltese: - Luminity jista' jiġi dilwit b'soluzzjoni ta' 9 mg/ml (0.9%) ta' sodium chloride għal injezzjoni jew soluzzjoni ta' 50 mg/ml (5%) ta' glukosju għal injezzjoni.
English: 1.5 ml liquid in clear borosilicate Type I glass vial, closed with a chlorobutyl elastomeric lyophilisation stopper, and sealed with an aluminium crimp seal having a plastic flip-off button.
Maltese: Kunjett ċar tal-ħġieġ tal-borosilikat tat-tip I b'1.5 ml ta' likwidu, magħluq b'tapp tal-chlorobutyl elastomeric lyophilisation, u ssiġillat b'siġill irbattut ta' l-aluminju li jkollu buttuna tal-plastik tat-tip flip-off.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol ta' sodium (23 mg) għal kull doża, jiġifieri essenzjalment huwa ‘ħieles mis-sodium'.
English: Patients with Cardiac Shunts
Maltese: Pazjenti b'Mogħdijiet (Shunts)
English: Luminity is a gas and solvent for dispersion for injection or infusion.
Maltese: Luminity huwa gass u solvent għal dispersjoni għal injezzjoni jew infużjoni.
English: Do not use Luminity after the expiry date which is stated on the carton and label after EXP. Before activation (shaking), store in a refrigerator (2°C - 8°C).
Maltese: Qabel attivazzjoni (taħwid), aħżen fi friġġ (2°C - 8°C).
English: Serious immediate hypersensitivity reactions (eg: anaphylaxis, anaphylactic shock and anaphylactoid reactions, hypotension and angioedema) have been reported following the administration of Luminity.
Maltese: Wara l-għoti ta' Luminity, ġew irrapportati reazzjonijiet ta' sensittività eċċessiva immedjati u serji (eż: anafilassi, xokk anafilattiku u reazzjonijiet anafilaktojde, pressjoni baxxa u anġjoedema).
English: Luminity contains sodium.
Maltese: Luminity fih is-sodium
English: Nervous system disorders Common: Headache
Maltese: Disturbi fis-sistema nervuża Komuni: Uġigħ ta' ras Mhux komuni: Sturdament, Disgewżja
English: • back pain, chest pain,
Maltese: • ħass ħażin,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: • breathing problems, cough, dry throat, difficulty in swallowing,
Maltese: • problemi bit-teħid tan-nifs, sogħla, gerżuma xotta, diffikultà biex tibla',
English: • feeling hot and
Maltese: • sensazzjoni ta' sħana u
English: Further information
Maltese: Sorsi oħra ta' informazzjoni
English: During contrast-enhanced echocardiography, serious cardiopulmonary reactions, including fatalities, have occurred during or within 30 minutes of Luminity administration in patients including those with severe cardiac and pulmonary diseases (see section 4.8).
Maltese: seħħew waqt jew fi żmien 30 minuta mill-għoti ta' Luminity f'pazjenti li jinkludu dawk b'mard kardijaku u pulmonari sever (ara sezzjoni 4.8).
English: Before administering Luminity, the medicinal product must be activated by using a mechanical shaking device, the Vialmix, see section 6.6.
Maltese: Qabel jingħata Luminity, il-prodott mediċinali jrid jiġi attivat bl-użu ta' apparat għat-taħwid mekkaniku, il-Vialmix, ara sezzjoni 6.6.
English: Treatment of an overdose should be directed towards the support of all vital functions and prompt institution of symptomatic therapy.
Maltese: It-trattament ta' doża eċċessiva għandu jkun dirett lejn is-sostenn tal-funzjonijiet vitali kollha u l-introduzzjoni immedjata ta' terapija sintomatika.
English: PHARMACEUTICAL FORM
Maltese: MEDIĊINALI
English: Store in a refrigerator (2°C - 8°C) For storage conditions after activation of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħżin wara l-attivazzjoni tal-prodott mediċinali, ara sezzjoni 6.3
English: Intravenous infusion using non-linear contrast imaging technique (rest and stress) or fundamental imaging technique at rest:
Maltese: Infużjoni ġol-vina bl-użu tat-teknika ta' immaġni ta' kuntrast mhux lineari (mistrieħ u stress) jew bitteknika ta' immaġni fundamentali waqt il-mistrieħ:
English: Administration and mechanical activation procedure Luminity should not be administered by methods not specified in section 4.2 (e.g. intra-arterial injection).
Maltese: Luminity m'għandux jingħata permezz ta' metodi oħra mhux speċifikati f'sezzjoni 4.2 (eż. Injezzjoni fl-arterji).
English: • Numbness, tingling and or burning sensation,
Maltese: • Ħedla, tingiż jew sensazzjoni ta' ħruq,
English: The naturally occurring phospholipids in Luminity (see section 6.1) are distributed in the endogenous lipid pools in the body (for example, liver) whereas the synthetic component (MPEG5000) has been shown to be excreted in the urine in preclinical studies.
Maltese: Il-fosfolipidi li jseħħu b'mod naturali f'Luminity (ara sezzjoni 6.1) huma mqassma fil-postijiet endoġeniċi tal-lipidi fil-ġisem (pereżempju, il-fwied) filwaqt li l-komponent sintetiku (MPEG5000)
English: Uncommon: Chest Pain, fatigue, feeling hot, injection site pain Rare: Pyrexia, rigors
Maltese: Mhux komuni: Uġigħ fis-Sider, Għeja, Sensazzjoni ta' Sħana, Uġigħ fil-post fejn tingħata l-injezzjoni Rari:
English: Luminity is used in adults to obtain a clearer scan of the chambers of the heart, especially of the left ventricle, during echocardiography (a diagnostic test where an image of the heart is obtained using ultrasound).
Maltese: speċjalment tal-ventrikolu tax-xellug, waqt ekukardjografija (test dijanjostiku fejn tinkiseb stampa tal qalb bl-użu tal-ultrasound).
English: Rare: Abnormal electrocardiogram
Maltese: Elettrokardjogramma Abnormali Rappurtar ta' reazzjonijiet avversi suspettati
English: CLINICAL PARTICULARS 4.1 Therapeutic indications
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Note: if the product is allowed to stand for more than 5 minutes after activation, it should be resuspended with 10 seconds of hand agitation prior to syringe withdrawal from the vial.
Maltese: Nota: jekk il-prodott jitħalla joqgħod għal aktar minn 5 minuti wara l-attivazzjoni, huwa għandu jiġi sospiż mill-ġdid b'10 sekondi ta' aġitazzjoni bl-idejn qabel ma jinġibed bis-siringa mill-kunjett.
English: (listed in section 6).
Maltese: Prodott, sezzjoni 4.2).
English: Uncommon: Dizziness, dysgeusia
Maltese: Pazjenti b'indeboliment tal-fwied
English: In most subjects after 4-5 minutes, perflutren was undetectable in blood and expired air. Perflutren concentrations in blood were shown to decline in a mono-exponential fashion with a mean half-life of 1.3 minutes in healthy subjects and 1.9 minutes in COPD subjects.
Maltese: 1.3 minuti f'suġġetti b'saħħithom u ta' 1.9 minuti f'suġġetti b'COPD.
English: The safety of microspheres in patients on mechanical ventilation has not been established.
Maltese: Is-sigurtà tal-mikrosferi f'pazjenti fuq ventilazzjoni mekkanika ma ġietx stabbilita.