FrancophonIA/ELRC3.0 huggingface dataset:
English: One millilitre of IKERVIS contains 1 mg of ciclosporin.
Maltese: Millilitru wieħed ta' IKERVIS fih 1 mg ta' ciclosporin.
English: Percentage of patients who experienced a severe keratitis recurrence was 35% and 48% in patients treated 12 months and 6 months with IKERVIS respectively in the SANSIKA study.
Maltese: Il-perċentwal ta' pazjenti li kellhom okkorrenza mill-ġdid ta' keratite severa kien ta' 35% u 48% f'pazjenti ttrattati għal 12-il xahar u 6 xhur b'IKERVIS rispettivament fl-istudju SANSIKA.
English: ikervis
Maltese: Pożoloġija
English: IKERVIS should be administered last (see section 4.4).
Maltese: IKERVIS għandu jingħata l-aħħar (ara sezzjoni 4.4).
English: IKERVIS 1 mg/mL eye drops, emulsion ciclosporin
Maltese: IKERVIS 1 mg/mL qtar għall-għajnejn, emulsjoni ciclosporin
English: Santen Oy Sími: + 358 (0) 3 284 8111
Maltese: Tel: +358 (0) 3 284 8111
English: Elderly patients The elderly population has been studied in clinical studies.
Maltese: Il-popolazzjoni anzjana ġiet studjat fi studji kliniċi.
English: The proportion of responders in the IKERVIS group was 28.6%, compared to 23.1% in the vehicle group.
Maltese: Il-proporzjon ta' dawk li rrispondew fil-grupp ta' IKERVIS kien ta' 28.6%, meta mqabbel ma' 23.1% fil-grupp tal-likwidu mingħajr mediċina.
English: The following adverse reactions listed below were observed in clinical studies.
Maltese: Ir-reazzjonijiet avversa li ġejjin elenkati taħt kienu osservati fi studji kliniċi.
English: No impairment of fertility has been reported in animals receiving intravenous ciclosporin (see section
Maltese: Ma kienx irrappurtat indeboliment fil-fertilità f'annimali li rċevew ciclosporin fil-vini (ara sezzjoni
English: Irritation, redness, and increase in tears when the drops are put into the eye, redness of the eyelid, watery eyes, eye redness, blurred vision.
Maltese: Irritazzjoni fis-sit fejn tqattar, eritema fis-sit fejn tqattar, dmugħ fis-sit fejn tqattar.
English: Patients randomised to the vehicle group were switched to IKERVIS after 6 months.
Maltese: Pazjenti randomised għall-grupp tal-likwidu mingħajr mediċina inqalbu għal IKERVIS wara 6 xhur.
English: In the 6 month, double-masked, vehicle controlled, supportive clinical trial (SICCANOVE study), 492 DED patients with moderate to severe keratitis (defined as a CFS score of 2 to 4) were also randomised to IKERVIS or vehicle daily at bedtime for 6 months.
Maltese: Fil-prova klinika ta' 6 xhur, double-masked, ta' appoġġ u kkontrollata bil-likwidu mingħajr mediċina (studju SICCANOVE), 492 pazjent b'DED b'keratite moderata sa severa (definita bħala punteġġ ta' CFS ta' 2 sa 4) kienu randomised ukoll għal IKERVIS jew għal-likwidu mingħajr mediċina kuljum qabel l-irqad għal 6 xhur.
English: The severity of keratitis, assessed using CFS, improved significantly from baseline at Month 6 with IKERVIS compared to vehicle (mean change from baseline was -1.764 with IKERVIS vs. -1.418 with vehicle, p=0.037).
Maltese: Is-severità tal-keratite, evalwata bl-użu ta' CFS tjiebet b'mod sinifikanti mil-linja bażi f'Xahar 6 b'IKERVIS meta mqabbel mal-likwidu mingħajr mediċina (bidla medja mil-linja bażi kienet ta'1.764 b'IKERVIS kontra -1.418 bil-likwidu mingħajr mediċina, p=0.037).
English: How to store IKERVIS 6.
Maltese: Kif taħżen IKERVIS 6.
English: IKERVIS 1 mg/mL eye drops, emulsion
Maltese: IL-PRODOTT MEDIĊINALI IKERVIS 1 mg/mL qtar għall-għajnejn, emulsjoni
English: Santen Pharmaceutical Spain S.L.
Maltese: Danmark SantenPharma AB
English: Common (may affect up to 1 in 10 people)
Maltese: Komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10)
English: • Open the aluminium pouch, which contains 5 single-dose containers.
Maltese: • Iftaħ il-borża ż-żgħira tal-aluminju, li fiha 5 kontenituri ta' doża waħda.
English: Pharmacotherapeutic group: Ophthalmologicals, other ophthalmologicals, ATC code: S01XA18.
Maltese: Oftalmoloġiċi, oftalmoloġiċi oħrajn, Kodiċi ATC:
English: Eye drops, emulsion.
Maltese: U KONTENUT Qtar għall-għajnejn, emulsjoni.
English: In addition, no improvement was observed for IKERVIS compared to vehicle at Month 6 for other secondary endpoints, including ocular discomfort score, Schirmer test, use of concomitant artificial tears, investigator's global evaluation of efficacy, tear break-up time, lissamine green staining, quality of life score, and tear osmolarity.
Maltese: Barra dan, ma kien osservat l-ebda titjib għal IKERVIS meta mqabbel mal-likwidu mingħajr mediċina f'Xahar 6 għall-punti finali sekondarji oħra, inkluż punteġġ ta' skonfort fl-għajnejn, test ta' Schirmer, użu ta' dmugħ artifiċjali fl-istess waqt, valutazzjoni globali tal-investigatur dwar l-effikaċja, ħin li fih tinħall qatra dmugħ, tlewwin b'lissamine green, punteġġ tal-kwalità tal-ħajja, u osmolarità tad-dmugħ.
English: The proportion of IKERVIS-treated patients with a 3-grade improvement in CFS score at Month 6 (from 4 to 1) was 28.8%, compared to 9.6% of vehicle-treated subjects, but this was a post-hoc analysis, which limits the robustness of this outcome.
Maltese: Il-proporzjon ta' pazjenti kkurati b'IKERVIS b'titjib ta' grad 3 fil-punteġġ ta' CFS f'Xahar 6 (minn 4 sa 1) kien ta' 28.8%, meta mqabbel ma' 9.6% ta' individwi kkurati bil-likwidu mingħajr mediċina, iżda din kienet analiżi posthoc, li tillimita r-robustezza ta' dan ir-riżultat.
English: Each single-dose container contains 0.3 mL eye drops, emulsion.
Maltese: Kull kontenitur b'doża waħda fih 0.3 mL ta' qtar għall-għajnejn, emulsjoni.
English: 1 mL of emulsion contains 1 mg of ciclosporin.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA 1 mL ta' emulsjoni fih 1 mg ta' ciclosporin.
English: A small but statistically significant difference in CFS improvement was observed between the treatment groups at Month 6 in favour of IKERVIS (mean change from baseline in CFS -1.05 with IKERVIS and -0.82 with vehicle, p=0.009).
Maltese: Kienet osservata differenza żgħira iżda statistikament sinifikanti fit-titjib f'CFS bejn il-gruppi ta' kura f'Xahar 6 favur IKERVIS (bidla medja mil-linja bażi f'CFS ta' -1.05 b'IKERVIS u ta' -0.
English: IKERVIS is used to treat adults with severe keratitis (inflammation of the cornea, the transparent layer in the front part of the eye).
Maltese: IKERVIS jintuża biex jikkura adulti b'keratite severa (infjammazzjoni tal-kornea, is-saff trasparenti fil-parti ta' quddiem tal-għajn).
English: How to store IKERVIS
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: In both studies one third of the patients in average had Sjögren's syndrome; as for the overall population, a statistically significant improvement in CFS in favour of IKERVIS was observed in this subgroup of patients.
Maltese: Fiż-żewġ studji medja ta' terz tal-pazjenti kellhom is-sindrome ta' Sjögren; għall-popolazzjoni globali, kien osservat titjib statistikament sinifikanti f'CFS favur IKERVIS f'dan is-sottogrupp ta' pazjenti.
English: Therefore, caution should be exercised when corticosteroids are administered concomitantly with Ikervis (see section 4.5).
Maltese: Għalhekk, għandu jkun hemm kawtela meta kortikosterojdi jingħataw flimkien ma' IKERVIS (ara sezzjoni 4.5).
English: Common Erythema of eyelid, lacrimation increased, ocular hyperaemia, vision blurred, eyelid oedema, conjunctival hyperaemia, eye irritation, eye pain.
Maltese: Eritema tal-kappell tal-għajn, żieda fid-dmugħ, iperimija fl-għajnejn, vista mċajpra, edima fil-kappell tal-għajn,
English: Ísland
Maltese: Il-Finlandja
English: One mL of emulsion contains 1 mg of ciclosporin.
Maltese: U KWANTITATTIVA Ml wieħed ta' emulsjoni fih 1 mg ta' ciclosporin.
English: In patients with dry eye disease, a condition that may be considered to have an inflammatory immunological mechanism, following ocular administration, ciclosporin is passively absorbed into Tlymphocyte infiltrates in the cornea and conjunctiva and inactivates calcineurin phosphatase.
Maltese: F'pazjenti b'marda tal-għajnejn xotti, kondizzjoni li tista' tiġi kkunsidrata li għandha mekkaniżmu immunoloġiku infjammatorju, wara għoti fl-għajn, ciclosporin jiġi assorbit b'mod passiv fl-infiltrati tal-limfoċiti-T fil-kornea u fil-konġuntiva u jinattiva calcineurin phosphatase.
English: Package leaflet: Information for the patient IKERVIS 1 mg/mL, eye drops, emulsion ciclosporin
Maltese: TAL-PRODOTT MEDIĊINALI ikervis 1 mg/mL qtar għall-għajnejn, emulsjoni ciclosporin
English: Three patients had values above the upper limit of quantification (5 ng/mL) however they were already taking oral ciclosporin at a stable dose, which was allowed by the studies' protocol.
Maltese: Tliet pazjenti kellhom valuri 'l fuq mill-ogħla limitu ta' kwantifikazzjoni (5 ng/mL) madankollu dawn diġà kienu qed jieħdu ciclosporin orali f'doża stabbli, kif permess mill-protokoll tal-istudji.
English: Milky white emulsion.
Maltese: - Din il-mediċina ġiet mogħtija lilek biss.
English: Excipient IKERVIS contains cetalkonium chloride which may cause eye irritation.
Maltese: Eċċipjent IKERVIS fih cetalkonium chloride li jista' jikkawża irritazzjoni fl-għajnejn.
English: Santen GmbH Tel: +49 (0) 3030809610
Maltese: Deutschland Santen GmbH Tel: +49 (0)
English: In five clinical studies including 532 patients who received IKERVIS and 398 who received IKERVIS vehicle (control), IKERVIS was administered at least once a day in both eyes, for up to one year.
Maltese: F'ħames studji kliniċi li kienu jinkludu 532 pazjent li rċevew IKERVIS u 398 li rċevew il-likwidu ta' IKERVIS mingħajr il-mediċina (kontroll), IKERVIS ingħata mill-inqas darba kuljum fiż-żewġ għajnejn, għal perjodu ta' mhux aktar minn sena.
English: Ciclosporin-induced inactivation of calcineurin inhibits the dephosphorylation of the transcription factor NF-AT and prevents NF-AT translocation into the nucleus, thus blocking the release of proinflammatory cytokines such as IL-2.
Maltese: NF-AT u tipprevjeni t-traslokazzjoni ta' NF-AT għal ġon-nukleu, u b'hekk timblokka ir-reħa ta' ċitokini pro-infjammatorji bħal IL-2.
English: The efficacy and safety of IKERVIS were evaluated in two randomised, double-masked, vehiclecontrolled clinical studies in adult patients with dry eye disease (keratoconjunctivitis sicca) who met the International Dry Eye Workshop (DEWS) criteria.
Maltese: L-effikaċja u s-sigurtà ta' IKERVIS kienu evalwati f'żewġ studji kliniċi randomised, double-masked u kkontrollati bil-likwidu mingħajr mediċina f'pazjenti adulti li jbatu mill-marda tal-għajnejn xotti (keratokonġuntivite sikka) li ssodisfaw il-kriterji Internazzjonali tal-Workshop tal-Għajn Xotta (DEWS - Dry Eye Workshop).
English: Santen UK Limited Tel: + 44 (0) 845 075 4863
Maltese: United Kingdom Santen UK Limited Tel: +44
English: Uncommon side effects related to the eye:
Maltese: Kienu rrappurtati l-effetti sekondarji li ġejjin:
English: Ciclosporin appears to block the resting lymphocytes in the G0 or G1 phase of the cell cycle.
Maltese: Ciclosporin jidher li jimblokka l-limfoċiti rieqda fil-fażi G0 jew G1 taċ-ċiklu taċ-ċellula.
English: • Take one single-dose container from the aluminium pouch.
Maltese: • Aqbad kontenituri wieħed ta' doża waħda mill-borża ż-żgħira tal-aluminju.
English: After the 24-month period, 61.3% of 62 patients included in the primary efficacy population did not experience a relapse based on CFS scores.
Maltese: Wara l-perjodu ta' 24 xahar, 61.3% ta' 62 pazjent inklużi fil-popolazzjoni tal-effikaċja primarja ma kellhomx rikaduta bbażat fuq punteġġi tas-CFS.
English: Studies in animals have shown reproductive toxicity following systemic administration of ciclosporin at exposure considered sufficiently in excess of the maximum human exposure indicating little relevance to the clinical use of IKERVIS.
Maltese: Studji f'annimali urew effett tossiku fuq is-sistema riproduttiva wara għoti sistemiku ta' ciclosporin f'esponiment meqjusa ferm ogħla mill-esponiment massimu fil-bniedem li jindika rilevanza żgħira għall-użu kliniku ta' IKERVIS.
English: Date of latest renewal: 24 April 2006
Maltese: Data tal-aħħar tiġdid: 24 ta' April 2006
English: The mean terminal half-life was 12 minutes (range 2 to 33 minutes).
Maltese: Il-medja tal-half-life terminali kienet ta' 12-il minuta (medda ta' bejn 2 u 33 minuta).
English: v1.0-08/2000 ©BRG 2000
Maltese: v1.0-08/2000
English: MARKETING AUTHORISATION NUMBERS EU/1/01/177/002
Maltese: FIS-SUQ EU/1/01/177/002
English: NL - 1077 ZX Amsterdam The Netherlands
Maltese: NL - 1077 ZX Amsterdam
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 March 2001
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 26 ta' Marzu 2001
English: Rare (≥ 1/10,000 to < 1/1000)
Maltese: Rari (≥ 1/10,000 sa
English: Bracco International B.V., Strawinskylaan 3051, NL - 1077 ZX Amsterdam, The Netherlands
Maltese: Bracco International B.V., Strawinskylaan 3051, NL - 1077 ZX Amsterdam, L-Olanda
English: The safety of SonoVue after intravenous administration was evaluated in 4653 adult patients who participated in 58 clinical trials.
Maltese: Is-sigurtà ta' SonoVue wara l-għoti ġol-vini ġiet evalwata f'4653 pazjent adult li ħadu sehem fi 58 prova klinika.
English: • Risk Management Plan ( RMP)
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP)
English: Doppler of microvasculature
Maltese: Doppler tal-mikrovaskulatura
English: - The other ingredients are: macrogol 4000, distearoylphosphatidylcholine,
Maltese: - Is-sustanzi l-oħra huma: macrogol 4000, distearoylphosphatidylcholine,
English: For the limitation in the interpretation of a negative urosonography, see section 4.4. and 5.1.
Maltese: Għal-limitazzjoni fl-interpretazzjoni ta' urosonografija negattiva, ara sezzjoni 4.4 u 5
English: Ultrasonography of excretory urinary tract
Maltese: Ultrasonografija tal-passaġġ urinarju eskretali
English: Vision blurred,
Maltese: Vista mċajpra,
English: Headache, paraesthesia, dizziness, dysgeusia
Maltese: Uġigħ ta' ras, parasteżija, sturdament, disġewsja
English: No clinical data are available.
Maltese: Ma hemm l-ebda data klinika disponibbli.
English: Via Ribes 5, Bioindustry Park Colleretto Giacosa - 10010 (TO) Italy
Maltese: Bracco Imaging S.p.A Via Ribes 5, Biondustry Park Colleretto Giacosa - 10010 ( TO) L-Italja
English: Myocardial infarction** Myocardial ischemia**
Maltese: Infart talmijokardijaku**, Iskemja talmijokardijaku**
English: Adverse Drug Reactions Frequency Category
Maltese: Reazzjonijiet Avversi għal Mediċina Kategorija ta' Frekwenza
English: In the second study including 228 patients (463 kidney-ureter units), SonoVue ultrasound was correctly positive in 57 out of 71 units with reflux and correctly negative in 302 out of 392 units without reflux.
Maltese: Fit-tieni studju li fih ħadu sehem 228 pazjent (463 unità ta' kliewi-ureteri), ultrasound b'SonoVue kien korrettament pożittiv f'57 minn 71 unità b'rifluss u korrettament negattiv fi 302 unitajiet mingħajr rifluss minn 392.
English: Do not use SonoVue:
Maltese: Tużax SonoVue:
English: Musculoskeletal, connective tissue and bone disorders
Maltese: Disturbi muskolu-skeletriku, tat-tessuti konnettivi
English: Doppler of macrovasculature
Maltese: Doppler tal-makrovaskultura
English: In one study including 183 patients (366 kidney-ureter units), SonoVue ultrasound was correctly positive in 89 out 103 units with reflux and correctly negative in 226 out of 263 units without reflux.
Maltese: Fi studju li fih ħadu sehem 183 pazjent (366 unità ta' kliewi-ureteri), ultrasound b'SonoVue kien korrettament pożittiv f'89 minn 103 unità b'rifluss u korrettament negattiv f'226 minn 263 unità mingħajr rifluss.
English: The adverse reactions are classified by System Organ Class and frequency, using the following convention: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < /100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), not known (cannot be estimated from the available data)
Maltese: Komuni ħafna (≥ 1/10), Komuni (≥ 1/100 sa < 1/10), Mhux komuni (≥ 1/1,000 sa < 1/100), Rari (≥ 1/10,000 sa < 1/1,000), Rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Marketing authorisation holder Bracco International B.V.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Bracco International B.V.
English: 2 years.
Maltese: 2 mL.
English: In a Phase I study doses up to 52 mL of SonoVue were administered to normal volunteers without serious adverse events being reported.
Maltese: Fi studju ta' Fażi I, dożi li sa 52 mL ta' SonoVue ingħataw lil voluntiera normali u ma kienu rrappurtat avvenimenti avversi serji.
English: Vasovagal reaction
Maltese: Reazzjoni vażovagali
English: The microbubbles have a mean diameter of about 2.5 µm, with 90% having a diameter less than 6 µm and 99% having a diameter less than 11 µm.
Maltese: Il-bżieżaq żgħar għandhom dijametru medju ta' madwar 2.5 µm, b'90% li jkollhom dijametru ta' inqas minn 6 µm u 99% jkollhom dijametru ta' inqas minn 11 µm.
English: - If you have severe pulmonary hypertension (pulmonary artery pressure > 90mmHg).
Maltese: - Jekk għandek pressjoni għolja ħafna tad-demm fl-arterja pulmonari (pressjoni fl-arterja pulmonari > 90 mmHg).
English: Paediatric population-Intravesical use
Maltese: Popolazzjoni pedjatrika-Użu intravessikali
English: Uncommon (≥ 1/1,000 to < 1/100)
Maltese: Mhux komuni (≥ 1/1,000 sa
English: Most of the side effects to SonoVue are rare and usually not serious.
Maltese: Ħafna mill-effetti sekondarji ta' SonoVue huma rari u ġeneralment ma jkunux serji.
English: For the full list of excipients, see section 6.1
Maltese: Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: • In paediatric patients the recommended dose of SonoVue is 1mL.
Maltese: • F'pazjenti pedjatriċi d-doża rakkomandata ta' SonoVue hija ta' 1 mL.
English: The recommended dose is 2 or 2.4 mL per patient.
Maltese: Id-doża rakkomandata hi ta' 2 jew 2.4 mL kull pazjent.
English: The following side effects have been reported with SonoVue:
Maltese: Li ġejjin huma effetti sekondarji rrapportati b'SonoVue:
English: - If you have adult respiratory distress syndrome (a severe, medical condition characterized by widespread inflammation in the lungs).
Maltese: - Jekk għandek sindrome ta' distress respiratorju fl-adulti (kundizzjoni medika severa karatterizzata b'infjammazzjoni mifruxa fil-pulmun.
English: * Cases suggestive of hypersensitivity may include: skin erythema, bradycardia, hypotension, dyspnoea, loss of consciousness, cardiac/cardio-respiratory arrest, anaphylactic reaction, anaphylactic shock.
Maltese: * Każijiet suġġestivi ta' sensittività eċċessiva jistgħu jinkludu eritema tal-ġilda, bradikardja, pressjoni baxxa, dispnea, nuqqas ta' koxjenza, arrest kardijaku/kardjorespiratorju, reazzjoni anafilattika, xokk anafilattiku.
English: Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: Echocardiography
Maltese: Ekokardjografija
English: Patients with unstable cardiopulmonary status
Maltese: Pazjenti bi status kardjopulmonari instabbli
English: Intravesical local tolerance for SonoVue was also assessed.
Maltese: Ġiet ivvalutata wkoll it-tolleranza intravessikali lokali għal SonoVue.
English: 4.6 Pregnancy, lactation, and fertility
Maltese: .6 Fertilità, tqala u treddigħ
English: At the proposed clinical doses for intravenous administration, SonoVue has been shown to provide marked increase in signal intensity of more than 2 minutes for B-mode imaging in echocardiography and of 3 to 8 minutes for Doppler imaging of the macrovasculature and microvasculature.
Maltese: Fid-dożi kliniċi proposti għall-għoti ġol-vini, intwera li SonoVue jipprovdi żieda ċara fl-intensità tassinjal ta' iktar minn 2 minuti għall-immaġni tal-B-mode fl-ekokardjografija u ta' minn 3 sa 8 minuti għall-immaġni Doppler tal-makrovaskulatura u l-mikrovaskulatura.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of the dispersion contains 8 µL sulphur hexafluoride microbubbles, equivalent to 45 micrograms.
Maltese: U KWANTITATTIVA Kull mL fih 8 µl tad-dispersjoni fih bżieżaq żgħar ta' eżafluworur tal-kubrit, ekwivalenti għal 45 mikrogramma.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu .
English: The safety of SonoVue after intravesical administration was based on evaluation of published literature involving use of SonoVue in over 6000 paediatric patients (age range 2 days to 18 years).
Maltese: Is-sigurtà ta' SonoVue wara l-għoti intravessikali kienet ibbażata fuq valutazzjoni ta' letteratura ppubblikata li kienet tinvolvi l-użu ta' SonoVue fuq aktar minn 6000 pazjent pedjatriku (medda ta' età minn jumejn sa 18-il sena).
English: This dose might be repeated if needed up to 4.8 mL.
Maltese: Din id-doża tista' tiġi ripetuta jekk meħtieġ sa 4.8 mL.
English: After a single intravenous injection of 0.03 or 0.3 mL of SonoVue/kg (approximately 1 and 10 times the maximum clinical dose) to human volunteers, the sulphur hexafluoride was cleared rapidly.
Maltese: Wara injezzjoni waħda ġol-vina ta' 0.03 jew 0.3 mL ta' SonoVue/kg (madwar 1 sa 10 darbiet tad-doża klinika massima) lil voluntiera umani, l-eżafluworur tal-kubrit tneħħa malajr.
English: If you have a serious pulmonary or cardiac condition you will be under close medical supervision during and for at least 30 minutes after the injection of SonoVue.
Maltese: Jekk għandek kundizzjoni pulmonari jew kardijaka serja ser tkun taħt superviżjoni medika mill-qrib waqt u għal tal-inqas 30 minuta wara l-injezzjoni ta' SonoVue.
English: Moreover, ECG and blood pressure monitoring should be performed during SonoVue-enhanced echocardiography with a pharmacological stress (e.g. with dobutamine).
Maltese: Barra minn hekk, għandu jsir monitoraġġ bl-ECG u tal-pressjoni tad-demm matul l-ekokardjografija mtejba permezz ta' SonoVue bi stress farmakoloġiku (eż. b'dobutamine).
English: System Organ Class
Maltese: istema tal-Klassifika tal-Organi
English: Intravenous use
Maltese: Użu intravessikali
English: Final study report to be submitted by 2Q 2020
Maltese: Rapport finali tal-istudju għandu jiġi ppreżentat sa K2 2020
English: SonoVue increases the accuracy in detection or exclusion of abnormalities in cerebral arteries and extracranial carotid or peripheral arteries in adult patients by improving the Doppler signal to noise ratio.
Maltese: SonoVue jżid l-eżattezza ta' l-indikazzjoni jew l-esklużjoni ta' anormalitajiet fl-arterji ċerebrali u fil-karotide extrakranjali jew fl-arterji periferali f'pazjenti adulti billi jtejjeb ir-rata Doppler signal to noise ratio.
English: Unscrew the syringe from the transfer system.
Maltese: Ħoll is-siringa mis-sistema tat-trasferiment.
English: Other medicines and SonoVue
Maltese: Mediċini oħra u SonoVue
English: SonoVue is indicated for use in ultrasonography of the excretory tract in paediatric patients from newborn to 18 years to detect vesicoureteral reflux.
Maltese: SonoVue huwa indikat għall-użu f'ultrasonografija tal-passaġġ eskretali f'pazjenti pedjatriċi mittwelid sa 18-il sena għad-detezzjoni ta' rifluss vesikureterali.
English: Solvent: Sodium chloride 9 mg/mL (0.9%) solution for injection.
Maltese: Sodium chloride 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni
English: METHOD OF ADMINISTRATION
Maltese: MANIFATTURA RESPONSABBLI
English: Uncommon side effects (may affect up to 1 in 100 people): - Headache - Numbness - Dizziness - Strange taste in the mouth - Redness - Chest discomfort - Feeling sick (nausea) - Abdominal pain - Skin rash - Feeling hot - Local reactions where the injection was given such as: pain or an unusual sensation at the injection site
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 f'100): - Uġigħ ta' ras - Tirżiħ - Stordament - Togħma stramba fil-ħalq - Ħmura - Skonfort tas-sider - Tħossok marid (dardir) - Uġigħ ta' żaqq - Raxx tal-ġilda - Tħossok sħun - Reazzjonijiet lokali fejn ingħatat l-injezzjoni bħal: uġigħ jew sensazzjoni mhux tas-soltu fis-sit tal-injezzjoni