FrancophonIA/ELRC3.0 huggingface dataset:
English: Ventavis 20 microgram/ml; 1 ml
Maltese: Ventavis 20 mikrogramma/ml; 1 ml
English: Bayer Vital GmbH Tel: +49 (0)214-30 513 48
Maltese: Tel: +49 (0)214-30 513 48
English: Polígono Industrial Santa Rosa s/n 28806 Alcalá de Henares Madrid
Maltese: Polígono Industrial Santa Rosa s/n
English: • I-Neb nebuliser
Maltese: • Nebulizzatur I-Neb
English: Chest discomfort / chest pain Cough
Maltese: Skomdu/uġigħ fis sider
English: The I-Neb AAD nebuliser has been shown to be suitable for the administration of Ventavis 10 microgram/ml (1 ml ampoule) and 20 microgram/ml nebuliser solution.
Maltese: In-nebulizzatur I-Neb AAD intwera li hu adattat għall-għoti ta' Ventavis 10 mikrogrammi/ml (ampulla ta' 1 ml) u 20 mikrogramma/ml soluzzjoni għan-nebulizzatur.
English: For administration with the Venta-Neb.
Maltese: istruzzjoni tan-nebulizzatur Venta-Neb.
English: 30 AMPOULES WITH 1 ML
Maltese: 30 ampulla b'1 ml
English: - Multipack containing 168 (4x42) ampoules for use with the Breelib and I-Neb nebuliser.
Maltese: - Pakkett multiplu li fih 168 (4x42) ampulla għall-użu man-nebulizzatur Breelib u I-Neb.
English: Multipack containing 168 (4x42) ampoules for use with the Breelib and I-Neb nebuliser.
Maltese: Pakkett multiplu li fih 168 (4x42) ampulla għall-użu man-nebulizzatur Breelib u I-Neb.
English: 42 AMPOULES WITH 1 ML
Maltese: 42 ampulla b'1 ml
English: 30 ampoules with 2 ml.
Maltese: 30 ampulla b'2 ml.
English: Treatment of adult patients with primary pulmonary hypertension, classified as NYHA functional class III, to improve exercise capacity and symptoms.
Maltese: Trattament ta' pazjenti adulti bi pressjoni pulmonari għolja primarja, ikklassifikata bħala klassi funzjonali
English: Following intravenous infusion, the recovery of total radioactivity is 81 %, and the respective recoveries in urine and faeces are 68% and 12%.
Maltese: l-irkupru tar-radjuattività totali hu ta' 81%, u l-irkupri rispettivi fl-awrina u fil-ħmieġ huma ta' 68% u
English: The duration of an inhalation session with Breelib nebuliser is approximately 3 minutes, which reflects the higher delivery rate of the Breelib compared to other nebulisers.
Maltese: It-tul ta' sessjoni ta' teħid man-nifs bin-nebulizzatur Breelib huwa madwar 3 minuti, li jirrifletti r-rata ta' twassil ogħla ta' Breelib meta mqabbel ma' nebulizzaturi oħra.
English: Ventavis 10 microgram/ml nebuliser solution (1 ml ampoule)
Maltese: Ventavis 10 mikrogrammi/ml soluzzjoni għan-nebulizzatur (ampulla ta' 1 ml)
English: The ready-to-use Ventavis nebuliser solution is administered with a suitable inhalation device (nebuliser) (see below and section 6.6).
Maltese: Is-soluzzjoni għan-nebulizzatur lesta biex tintuża ta' Ventavis tingħata b'apparat adattat għat-teħid man-nifs (nebulizzatur) (ara taħt u sezzjoni 6.6).
English: It imitates a natural substance in the body called prostacyclin.
Maltese: Din timita sustanza naturali fil-ġisem li tissejjaħ prostacycline.
English: Ventavis 10 microgram/ml; 2 ml
Maltese: Ventavis 10 mikrogrammi/ml; 2 ml
English: • P2 Programme 2: 2.5 microgram active substance on the mouth piece 10 inhalation cycles.
Maltese: • Programm P2 2: 2.5 mikrogrammi ta' sustanza attiva fuq il-biċċa tal-ħalq 10 ċikli ta'
English: 30 ampoules with 1 ml.
Maltese: 30 ampulla b'1 ml.
English: The I-Neb AAD System is a portable, hand-held, vibrating mesh technology nebuliser system.
Maltese: Is-sistema I-Neb AAD hi sistema ta' nebulizzatur portabbli, li tinżamm fl-idejn, tat-tip vibrating mesh technology (teknoloġija ta' xibka li tivvibra).
English: Ventavis 10 microgram/ml; 1 ml
Maltese: Ventavis 10 mikrogrammi/ml; 1 ml
English: The nebulising device delivers 5 microgram iloprost at the mouthpiece.
Maltese: L-apparat nebulizzanti jwassal 5 mikrogrammi ta' iloprost fil-biċċa tal-ħalq.
English: Venta-Neb, a portable ultrasonic battery-powered nebuliser, has been shown to be suitable for the administration of Ventavis 10 microgram/ml nebuliser solution (2 ml ampoule).
Maltese: • Venta-Neb Venta-Nab, nebulizzatur ultrasoniku li jista' jinġarr u li jaħdem bil-batteriji, intwera li hu adattat għall-għoti ta' Ventavis10 mikrogrammi/ml soluzzjoni għan-nebulizzatur (ampulla ta' 2 ml).
English: Venta-Neb, a portable ultrasonic battery-powered nebuliser, has also been shown to be suitable for the administration of Ventavis 10 microgram/ml.
Maltese: Venta-Neb Venta-Neb, nebulizzatur ultrasoniku li jista' jinġarr u li jaħdem bil-batteriji, ukoll intwera li hu adattat għall-għoti ta' Ventavis 10 mikrogrammi/ml.
English: Fatal cases included cerebral and intracranial haemorrhage.
Maltese: Każijiet fatali inkludew emorraġija ċerebrali u fil-kranju.
English: NOVAGEM Limited
Maltese: ANNESS III
English: Multipack: 90 (3 x 30) ampoules with 2 ml.
Maltese: Pakkett multiplu: 90 (3 x 30) ampulla b'2 ml. 100 ampulla b'2 ml.
English: Ελλάδα Bayer Ελλάς ΑΒΕΕ
Maltese: Nisa li jistgħu joħorġu tqal
English: Continuous intravenous/subcutaneous infusion of iloprost up to 26 weeks in rodents and non-rodents did not cause any organ toxicity at dose levels which exceeded the human therapeutic systemic exposure between 14 and 47 times (based on plasma levels).
Maltese: Infużjoni kontinwa fil-vini/taħt il-ġilda ta' iloprost sa 26 ġimgħa f'annimali gerriema u dawk mhux gerriema, ma' kkawżat l-ebda tossiċità ta' l-organi f'livelli ta' doża li qabżu l-espożizzjoni sistemika terapewtika fil-bnedmin bejn 14 u 47 darba (ibbażata fuq livelli fil-plażma).
English: • pain when swallowing (pharyngolaryngeal irritation)
Maltese: • uġigħ meta tibla' (irritazzjoni fil-farinġi u l-larinġi)
English: • chest discomfort / chest pain
Maltese: • skomdu fis-sider/uġigħ fis-sider
English: Pack containing 30 or 42 ampoules for use with the Breelib and I-Neb nebuliser.
Maltese: Pakkett fih 30 jew 42 ampulla għall-użu man-nebulizzatur Breelib u I-Neb.
English: In a study with intravenous infusion of iloprost, patients with end-stage renal failure undergoing intermittent dialysis treatment are shown to have a significantly lower clearance (mean CL = 5 ± 2 ml/minute/kg) than that observed in patients with renal failure not undergoing intermittent dialysis treatment (mean CL = 18 ± 2 ml/minute/kg).
Maltese: Fi studju b'infużjoni fil-vini ta' iloprost, pazjenti b'insuffiċjenza tal-kliewi ta' l-aħħar stadju li kienu qed jieħdu trattament intermittenti ta' dijalisi, intwera li għandhom tneħħija sinnifikattivament aktar baxxa (medja ta' CL = 5 ± 2 ml/min/kg) minn dak osservat f'pazjenti b'insuffiċjenza tal-kliewi li ma kienx qed ikollhom trattament intermittenti ta' dijalisi (medja ta' CL medja = 18 ± 2 ml/min/kg).
English: One inhalation session will usually last about 4 to 10 minutes with I-Neb AAD depending on the prescribed dose.
Maltese: Sessjoni ta' teħid man-nifs normalment iddum madwar 4 sa 10 minuti b'I-Neb AAD
English: Ventavis is a clear, colourless nebuliser solution for inhalation with the Breelib, the I-Neb or the Venta-Neb nebuliser.
Maltese: Ventavis huwa soluzzjoni għan-nebulizzatur ċara, mingħajr kulur biex tittieħed man-nifs binnebulizzatur Breelib, I-Neb jew Venta-Neb.
English: In a small, randomised, 12-week double-blinded, placebo-controlled study (the STEP trial), 34 patients treated with bosentan 125 mg twice per day for at least 16 weeks who were in stable haemodynamic conditions before enrolment, tolerated the addition of inhaled iloprost at the concentration of 10 microgram/ml (up to 5 microgram 6 to 9 times per day during waking hours).
Maltese: 34 pazjent ittrattati b'bosentan 125 mg darbtejn kuljum għal mill-inqas 16-il ġimgħa u li kienu f'kundizzjoni emodinamika stabbli qabel iddaħħlu fl-istudju, ittolleraw iż-żjieda ta' iloprost meħud man-nifs f'konċentrazzjoni ta' 10 mikrogrammi/ml (sa 5 mikrogrammi 6 sa 9 darbiet kuljum matul is sigħat li kienu mqajjma).
English: Cmax and AUC (0-tlast) after inhalation of 5 microgram iloprost administered as Ventavis 20 microgram/ml using the Breelib were 77% and 42%, respectively higher compared to inhalation of the same dose using Ventavis 10 microgram/ml and the I-Neb AAD system.
Maltese: 20 mikrogramma/ml permezz ta' Breelib kienu 77% u 42% ogħla rispettivament meta mqabbla ma'
English: Comparable systemic exposures (AUC (0-tlast)) and approximately 30% higher maximum serum concentrations (Cmax) were found following inhalation of Ventavis 20 microgram/ml compared to Ventavis 10 microgram/ml which was in line with the observed shorter inhalation time using Ventavis 20 microgram/ml.
Maltese: (AUC (0-tl-aħħar)) u konċentrazzjonijiet massimi fis-serum madwar 30% ogħla (Cmax) instabu wara teħid man-nifs ta' Ventavis 20 mikrogramma/ml meta mqabbel ma' Ventavis 10 mikrogrammi/ml, li kien jaqbel mal-ħin iqsar ta' teħid man-nifs osservat bl-użu ta' Ventavis 20 mikrogramma/ml.
English: When iloprost at the concentration of 10 microgram/ml is administered via inhalation in patients with pulmonary hypertension or healthy volunteers (iloprost dose at the mouthpiece: 5 microgram: inhalation time in between 4.6 - 10.6 min), mean peak serum concentrations of about 100 to 200 picogram/ml were observed at the end of inhalation session.
Maltese: ħin ta' ġbid man-nifs ta' 4.6 - 10.6 min), kienu osservati konċentrazzjonijiet massimi medji fis-serum ta' madwar 100 sa 200 pikogramma/ml fit-tmiem tas sessjoni ta' teħid man-nifs.
English: Not known (cannot be estimated from the available data):
Maltese: Mhux magħrufa (ma tistax tiġi stmata minn data disponibbli):
English: Following intravenous infusion, the apparent steady-state volume of distribution was 0.6 to 0.8 l/kg in healthy subjects.
Maltese: Wara infużjoni fil-vini, il-volum apparenti ta' distribuzzjoni fi stat fiss kien minn 0.6 sa 0.8 l/kg f'individwi f'saħħithom.
English: 1 ml solution contains 10 microgram iloprost (as iloprost trometamol).
Maltese: 1 ml ta' soluzzjoni fiha 10 mikrogrammi ta' iloprost (bħala iloprost trometamol).
English: Ventavis 20 mcg/ml 1 ml ampoule yellow-red ring
Maltese: Ventavis 20 mcg/ml ampulla ta' 1 ml ċirku isfar-aħmar
English: Data with intravenously administered iloprost indicated that the elimination is reduced in patients with hepatic dysfunction and in patients with renal failure requiring dialysis (see section 5.2).
Maltese: Data dwar iloprost mogħti ġol-vini ndikat li t-tneħħija hija mnaqqsa f'pazjenti bi problemi fil funzjoni tal-fwied u f'pazjenti b'insuffiċjenza tal-kliewi li jeħtieġu d-dijalisi (ara sezzjoni 5.2).
English: Different nebuliser devices can be used to administer Ventavis 20µg/ml.
Maltese: Jistgħu jintużaw apparati għan-nebulizzazzjoni differenti biex jingħata Ventavis 20µg/ml.
English: Ventavis 10 microgram/ml nebuliser solution Ventavis 20 microgram/ml nebuliser solution
Maltese: Ventavis 10 mikrogrammi/ml soluzzjoni għan-nebulizzatur Ventavis 20 mikrogramma/ml soluzzjoni għan-nebulizzatur
English: Package leaflet: Information for the user Ventavis 20 microgram/ml nebuliser solution
Maltese: Informazzjoni għall-utent Ventavis 20 mikrogramma/ml soluzzjoni għan-nebulizzatur
English: Use dosing intervals of 3 - 4 hours (this corresponds to a maximum of 6 administrations per day).
Maltese: Uża intervalli ta' dożaġġ ta' 3 - 4 sigħat (dan jikkorrispondi għal massimu ta' 6 għotjiet kuljum).
English: • P1 Programme 1: 5 microgram active substance on the mouth piece 25 inhalation cycles.
Maltese: • Programm P1 1: 5.0 mikrogrammi ta' sustanza attiva fil-biċċa tal-ħalq 25 ċiklu ta' teħid tan nifs.
English: Iloprost may increase the effects of vasodilatators and antihypertensive agents and then favour the risk of hypotension (see section 4.4).
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Iloprost jista' jżid l-effetti ta' vażodilataturi u ta' sustanzi li jbaxxu l-pressjoni tad-demm u jiffavorixxu r-riskju ta' pressjoni baxxa (ara sezzjoni 4.4).
English: Other medicines and Ventavis
Maltese: Mediċini oħra u Ventavis
English: Inhalation use
Maltese: Mhux applikabbli
English: PACK WITH 30 AMPOULES IN A CARTON WITH 90 (3 x 30) AMPOULES WITH 2 ML PACK WITH 30 AMPOULES IN A CARTON WITH 300 (10 x 30) AMPOULES WITH 2 ML
Maltese: F'KARTUNA B'90 (3 X 30) AMPULLA TA' 2 ML PAKKETT BI 30 AMPULLA
English: ACE inhibitors.
Maltese: o eptifibatide,
English: Syncope is a common symptom of the disease itself, but can also occur under therapy.
Maltese: Sinkope huwa sintomu komuni tal-marda nnifisha, iżda jista' jseħħ ukoll meta tkun qed tingħata terapija.
English: • fast heartbeat (tachycardia)
Maltese: • sens tat-togħma mibdul (disġewsja)
English: Ventavis 10 microgram/ml nebuliser solution 4 years.
Maltese: Ventavis 10 mikrogrammi/ml soluzzjoni għan-nebulizzatur 4 snin.
English: Patients with diseases of the respiratory tract
Maltese: Pazjenti b'mard tal-apparat respiratorju
English: The metabolites are eliminated from plasma and urine in 2 phases, for which half-lives of about 2 and 5 hours (plasma) and 2 and 18 hours (urine) have been calculated.
Maltese: Il-metaboliti huma eliminati mill-plażma u mill-awrina f'2 fażijiet, li għalihom kienu kkalkulati half-lives ta' madwar 2 u 5 siegħat (plażma) u 2 u 18-il siegħa (awrina).
English: P2 Programme 2: 2.5 microgram active substance on the mouth piece 10 inhalation cycles.
Maltese: Programm P2 2: 2.5 mikrogrammi ta' sustanza attiva fuq il-biċċa tal-ħalq 10 ċikli ta' teħid man-nifs.
English: 1 ml solution contains 20 microgram iloprost (as iloprost trometamol).
Maltese: 1 ml ta' soluzzjoni fih 20 mikrogramma ta' iloprost (bħala iloprost trometamol).
English: Pulmonary veno-occlusive disease
Maltese: Interruzzjoni tat-terapija
English: After intravenous administration, iloprost is extensively metabolised via ß-oxidation of the carboxyl side chain.
Maltese: Wara għoti fil-vini, iloprost huma metabolizzat b'mod estensiv permezz ta' l-ossidazzjoni ß tal katina karboxil tal-ġenb.
English: Drug product Ampoule coloured rings
Maltese: Ċrieki kkuluriti tal-ampulla
English: Ventavis 10 microgram/ml, nebuliser solution Iloprost
Maltese: Ventavis 10 mikrogrammi/ml, soluzzjoni għan-nebulizzatur Iloprost
English: 5 mcg purple purple
Maltese: 5 mcg vjola vjola
English: − Cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last 3 months.
Maltese: - Episodji ċerebrovaskulari (eż. attakk iskemiku temporanju, puplesija) matul l-aħħar 3 xhur.
English: EU/1/03/255/010 [168 (4 x 42) x 1 ml]
Maltese: [168 (4 x 42) x 1 ml]
English: The dose delivered by the I-Neb AAD system is controlled by the medication chamber in combination with a control disc. For each medication chamber there is a corresponding colour coded control disc.
Maltese: Id-doża ssettjata minn qabel ipprovduta mis-sistema I-Neb AAD hi kkontrollata mill kompartiment tal-mediċina flimkien ma' disk tal-kontroll.
English: In subjects with normal renal and hepatic function, the disposition of iloprost following intravenous infusion is characterised in most cases by a two-phase profile with mean half-lives of 3 to 5 minutes and 15 to 30 minutes.
Maltese: F'individwi b'funzjoni normali tal-kliewi u tal-fwied, id-dispożizzjoni ta' iloprost wara infużjoni fil-vini hija kkaratterizzata fil-biċċa l-kbira tal-każijiet minn profil b'żewġ fażijiet, b'half-lives medji ta' 3 sa 5 minuti u 15 sa 30 minuti.
English: The safety and efficacy of Ventavis in children aged up to 18 years have not been established.
Maltese: Is-sigurtà u effikaċja ta' Ventavis fi tfal b'età sa 18-il sena għadhom ma ġewx determinati s'issa.
English: The Mass Median Aerodynamic Diameter (MMAD) of the aerosol is between 1 and 5 micrometers.
Maltese: Id-Dijametru tal-Massa Erodinamika Medjana (MMAD - Mass Median Aerodynamic Diameter) tal-aerosol hu bejn
English: Multipack: 168 (4 x 42) ampoules with 1 ml co-packed with Breelib consumables set (containing 1 mouthpiece and 1 medication chamber).
Maltese: Pakkett multiplu: 168 (4 x 42) ampulla b'1 ml ippakkjati flimkien ma' set ta' oġġetti li jintużaw flimkien ma' Breelib (li fih biċċa tal-ħalq waħda u kompartiment tal-mediċina wieħed).
English: P1 Programme 1: 5 microgram active substance on the mouth piece 25 inhalation cycles.
Maltese: Programm P1 1: 5.0 mikrogrammi ta' sustanza attiva fuq il-biċċa tal-ħalq 25 ċiklu ta' teħid man-nifs.
English: Switching to the Breelib nebuliser
Maltese: Bidla għan-nebulizzatur Breelib
English: Hepatic impairment Iloprost elimination is reduced in patients with hepatic dysfunction (see section 5.2).
Maltese: It-tneħħija ta' iloprost hija mnaqqsa f'pazjenti b'disfunzjoni tal-fwied (ara sezzjoni 5.2).
English: Ventavis 20 microgram/ml nebuliser solution 1 ml solution contains 20 microgram iloprost (as iloprost trometamol).
Maltese: Ventavis 20 mikrogramma/ml soluzzjoni għan-nebulizzatur Soluzzjoni ta' 1 ml fiha 20 mikrogramma ta' iloprost (bħala iloprost trometamol).
English: Bayer S.p.A. Tel: +39 02 397 81
Maltese: Tel: +39 02 397 81
English: The baseline 6-minute walk test values reflected a moderate exercise limitation: in the iloprost group the mean was 332 metres (median value: 340 metres) and in the placebo group the mean was 315 metres (median value: 321 metres).
Maltese: Il-valuri fil-linja bażi tat-test ta' mixja ta' 6 minuti rriflettew limitazzjoni moderata fleżerċizzju: fil-grupp b'iloprost il-medja kienet ta' 332 metru (valur medjan:
English: Ventavis 10 microgram/ml nebuliser solution (1 ml ampoule) delivers 2.5 microgram and Ventavis 20 microgram/ml nebuliser solution delivers 5 microgram at the mouthpiece of the Breelib nebuliser.
Maltese: 2.5 mikrogrammi u Ventavis 20 mikrogramma/ml soluzzjoni għan-nebulizzatur iwassal 5 mikrogrammi fil-biċċa tal-ħalq tan-nebulizzatur Breelib.
English: Ventavis 20 microgram/ml nebuliser solution
Maltese: Ventavis 20 mikrogramma/ml soluzzjoni għan-nebulizzatur
English: In the iloprost group, the mean change from baseline after 12 weeks of treatment in the 6-minute walking distance was an increase of 22 metres (-3.3 metres in the placebo group, no data imputation for death or missing values).
Maltese: Fil-grupp ta' iloprost, il-medja ta' tibdil mill-linja bażi fid-distanza ta' mixja ta' 6 minuti wara 12il ġimgħa ta' trattament kienet żjieda ta' 22 metru (-3.3 metri fil-grupp tal-plaċebo, l-ebda imputazzjoni ta' informazzjoni għal mewt jew valuri neqsin).
English: Ventavis 10 microgram/ml nebuliser solution 1 ml solution contains 10 microgram iloprost (as iloprost trometamol).
Maltese: U KWANTITATTIVA Ventavis 10 mikrogrammi/ml soluzzjoni għan-nebulizzatur Soluzzjoni ta' 1 ml fiha 10 mikrogrammi ta' iloprost (bħala iloprost trometamol).
English: Ventavis 10 mcg/ml 1 ml ampoule white-yellow ring
Maltese: Ventavis 10 mcg/ml ampulla ta' 1 ml ċirku abjad-isfar
English: Each ampoule with 1 ml contains 20 microgram iloprost.
Maltese: Kull ampulla ta' 1 ml fiha 20 mikrogramma ta' iloprost.
English: There is no need for dose adaptation in patients with a creatinine clearance >30 ml/min (as determined from serum creatinine using the Cockroft and Gault formula).
Maltese: M'hemmx bżonn ta' adattament tad-doża f'pazjenti bi tneħħija tal-krejatinina ta' >30 ml/min (kif iddeterminat mill-kreatinina fis-serum bl-użu tal-formula ta' Cockroft u Gault).
English: In case of poor tolerability of the 5 microgram dose, the dose should be reduced to 2.5 microgram iloprost.
Maltese: F'każ ta' tollerabilità batuta tad-doża ta' 5 mikrogrammi, id-doża għandha titnaqqas għal 2.5 mikrogrammi ta' iloprost.
English: Device
Maltese: Apparat
English: No studies performed following inhalation.
Maltese: ilma għall-injezzjonijiet.
English: Ventavis 10 microgram/ml, Nebuliser solution Iloprost
Maltese: Ventavis 10 mikrogrammi/ml, soluzzjoni għan-nebulizzatur
English: Each ampoule with 2 ml contains 20 microgram iloprost.
Maltese: Kull ampulla ta' 2 ml fiha 20 mikrogramma ta' iloprost.
English: Since the I-Neb AAD nebuliser can be used for Ventavis 10 microgram/ml and Ventavis 20 microgram/ ml, the table below provides a summary of the user instructions of the I-Neb for the 2 concentrations of Ventavis:
Maltese: Peress li n-nebulizzatur I-Neb AAD tista' tintuża għal Ventavis 10 mikrogrammi/ ml u Ventavis 20 mikrogramma/ ml, it-tabella t'hawn taħt tipprovdi sommarju tal-istruzzjonijiet għall-utent ta' I-Neb għaż-żewġ konċentrazzjonijiet ta' Ventavis:
English: Results of in vitro studies reveal that CYP 450-dependent metabolism plays only a minor role in the biotransformation of iloprost.
Maltese: Riżultati ta' studji in vitro wrew li l-metaboliżmu, li jiddependi minn CYP 450, għandu biss funzjoni minuri fil-bijotrasformazzjoni ta' iloprost.
English: • Ventavis 20 microgram/ml nebuliser solution is inhaled using the nebulisers your doctor prescribed (either the Breelib or the I-Neb AAD nebuliser).
Maltese: • Is-soluzzjoni għan-nebulizzatur Ventavis 20 mikrogramma/ml tittieħed man-nifs bl-użu tan-nebulizzaturi li ppreskrivilek it-tabib tiegħek (in-nebulizzatur Breelib jew I-Neb AAD.
English: Each ampoule with 1 ml solution contains 10 microgram iloprost.
Maltese: Kull ampulla b'1 ml ta' soluzzjoni fiha 10 mikrogrammi ta' iloprost.
English: Ventavis should not be initiated in patients with systolic blood pressure less than 85 mmHg.
Maltese: Ventavis m'għandux jinbeda f'pazjenti bi pressjoni sistolika inqas minn 85 mmHg.
English: This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Maltese: Dan il-prodott mediċinali fih ammonti żgħar ta' ethanol (alkoħol), anqas minn 100 mg f'kull doża.
English: A potential risk to the breast-feeding child cannot be excluded and it is preferable to avoid breast-feeding during Ventavis therapy.
Maltese: Riskju potenzjali għat-tarbija li qed terda' ma jistax jiġi eskluż u huwa preferibbli li tevità t-treddigħ waqt terapija b'Ventavis.
English: Each ampoule with 2 ml solution contains 20 microgram iloprost.
Maltese: Kull ampulla b'2 ml ta' soluzzjoni fiha 20 mikrogramma ta' iloprost.
English: Ventavis 20 microgram/ml is double the concentration of Ventavis 10 microgram/ml.
Maltese: Ventavis 20 mikrogramma/ml għandu konċentrazzjoni d-doppju ta' Ventavis 10 mikrogrammi/ml.
English: • The other ingredients are trometamol, ethanol, sodium chloride, hydrochloric acid for pH adjustment, and water for injections.
Maltese: • Is-sustanzi l-oħra huma trometamol, ethanol, sodium chloride, hydrochloric acid għal aġġustament tal-pH, u ilma għall-injezzjonijiet.
English: • If you could get pregnant, use reliable contraception from the time you start treatment and during treatment.
Maltese: • Jekk tista' toħroġ tqila, uża kontraċezzjoni affidabbli minn meta tibda t-trattament u waqt it trattament.
English: • If you have liver problems or very severe kidney problems, requiring dialysis, tell your doctor.
Maltese: • Jekk għandek problemi fil-fwied, jew problemi severi ħafna fil-kliewi, li jeħtieġu dijalisi, għid lit-tabib tiegħek.
English: No data from controlled clinical trials are available.
Maltese: M'hemm l-ebda data disponibbli minn provi kliniċi kkontrollati.
English: Blood pressure should be checked while initiating Ventavis.
Maltese: skont id-doża preskritta.
English: Direct vasodilatation of the pulmonary arterial bed occur with consecutive significant improvement of pulmonary artery pressure, pulmonary vascular resistance and cardiac output as well as mixed venous oxygen saturation.
Maltese: Vasodilatazzjoni diretta tas-saff ta' l-arterji pulmonari sseħħ b'titjib konsekuttiv sinifikanti talpressjoni ta' l-arterja pulmonari, tar-reżistenza vaskulari pulmonari u tal-funzjoni tal-qalb kif ukoll tas-saturazzjoni mħallta ta' ossiġnu fil-vini.
English: Although, clinical studies have not been conducted, in vitro studies investigating the inhibitory potential of iloprost on the activity of cytochrome P450 enzymes revealed that no relevant inhibition of drug metabolism via these enzymes by iloprost is to be expected.
Maltese: Għalkemm ma sarux studji kliniċi, studji in vitro li nvestigaw il-potenzjal inibitorju ta' iloprost fuq lattività ta' l-enzimi taċ-ċitokromju P450 wrew li mhux mistennija l-ebda inibizzjoni rilevanti fuq ilmetaboliżmu tal-mediċina permezz ta' dawn l-enzimi minn iloprost.
English: PHARMACEUTICAL FORM
Maltese: Prodott mediċinali
English: Ventavis 20 mcg/ml (1 ml ampoule with yellow and red rings)
Maltese: Ventavis 20 mcg/ml (ampulla ta' 1 ml bi ċrieki ta' lewn isfar u aħmar)