FrancophonIA/ELRC3.0 huggingface dataset:
English: • Observed food effect for test and reference products As per the current recommendations for modified release formulations1,2, bioequivalence studies in fasted and fed conditions are required.
Maltese: • Effett osservat tal-ikel għat-test u l-prodotti ta' referenza Skont ir-rakkomandazzjonijiet attwali għal formulazzjonijiet b'rilaxx modifikat 1,2, hemm il-ħtieġa ta' studji ta' bijoekwivalenza f'kundizzjonijiet ta' sawm u mitmugħa.
English: • Dosing recommendations for didanosine
Maltese: Didanosine:
English: This is attributed to the delay in absorption rate of enteric coated formulation which is reflected in the Tmax which is about 2 hours for the enteric coated formulation compared to 0.67 hours for the buffered tablet.
Maltese: Fl max li huwa ta' madwar sagħtejn għall-formulazzjoni b'kisja enterika meta mqabbel ma' 0.67 siegħat għall-pillola buffered.
English: It contains the active substance insulin human (rDNA).
Maltese: Fih is-sustanza attiva insulina umana (rDNA).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) VELOSULIN EPAR summary for the public
Maltese: RAPPORT TAL-VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) VELOSULIN
English: The active substance in Velosulin, insulin human (rDNA), is produced by a method known as ‘recombinant DNA technology': the insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin.
Maltese: Is-sustanza attiva f'Velosulin, l-insulina umana (rDNA), hi prodotta b'metodu magħruf bħala ‘teknoloġija rekombinanti tad-DNA': l-insulina tiġi magħmula minn ħmira li tkun irċeviet ġene (DNA), li tagħmilha kapaċi tipproduċi l-insulina.
English: The marketing authorisation was renewed on 7 October 2007.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fis-7 ta' Ottubru 2007.
English: The European Commission granted a marketing authorisation valid throughout the EU for Velosulin to Novo Nordisk A/S on 7 October 2002.
Maltese: Il-Kummissjoni Ewropea tat l-awtorizzazzjoni għat-tqegħid fis-suq għal Velosulin valida fl-Unjoni Ewropea kollha lil Novo Nordisk A/S fis-7 ta' Ottubru 2002.
English: Velosulin is a solution for injection or infusion (drip).
Maltese: Velosulin hu soluzzjoni għall-injezzjoni jew infużjoni (dripp).
English: Why has Velosulin been approved?
Maltese: Għaliex ġie approvat Velosulin?
English: Velosulin is a replacement insulin that is identical to the insulin made by the pancreas.
Maltese: Velosulin hu insulina ta' sostituzzjoni identika għall-insulina magħmula millfrixa.
English: What is Velosulin?
Maltese: X'inhu Velosulin?
English: Velosulin is intended for continuous subcutaneous infusion (under the skin) using an insulin infusion pump.
Maltese: Velosulin ġie studjat ukoll meta użat f'pompa ta' l-insulina.
English: The studies used to support Velosulin are those that have been used to support Actrapid, another insulin approved in the European Union (EU).
Maltese: L-istudji użati biex jappoġġjaw Velosulin huma dawk li ntużaw biex jappoġġaw Actrapid, insulina oħra approvata fl-Unjoni Ewropea (UE).
English: As with all insulins, Velosulin may cause hypoglycaemia (low blood glucose).
Maltese: Bħall-insulini kollha, Velosulin jista' jikkawża ipogliċemija (livell baxx ta' zokkor).
English: For the full list of all side effects reported with Velosulin, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rappurtati ma' Velosulin, ara l-Fuljett ta' Tagħrif.
English: What is the risk associated with Velosulin?
Maltese: X'inhu r-riskju assoċjat ma' Velosulin?
English: Velosulin led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with the other human insulin.
Maltese: Velosulin wassal għal tnaqqis fil-livell ta' HbA1c, li juri li l-livelli ta' glukożju kienu ġew ikkontrollati għal livell simili għal dak li deher fl-insulina umana l-oħra.
English: Velosulin should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients.
Maltese: Velosulin m'għandux jintuża minn persuni allerġiċi għall-insulina umana (rDNA) jew għal kwalunkwe sustanza oħra tiegħu.
English: The studies measured the level of fasting blood sugar or a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Maltese: Il-mediċina tista' tinkiseb biss b'riċetta ta' tabib.
English: System organ class (MedDRA)
Maltese: Klassi tas-sistemi u tal-organi (MedDRA)
English: 3 minutes
Maltese: 3 minuti
English: • hypersensitivity (i.e. allergy)
Maltese: • sensittività eċċessiva (i.e. allerġija)
English: Peripheral oedema§
Maltese: Edima periferali§
English: Systemic toxicity
Maltese: Tossiċità sistemika
English: Bleeding events*§
Maltese: Avvenimenti ta' fsada*§
English: • 42 ampoules.
Maltese: • 42 ampulla.
English: • Stimulation of endogenous fibrinolytic potential
Maltese: • Stimulazzjoni tal-potenzjal fibrinolitiku endoġenu
English: Bayer AG 51368 Leverkusen Germany
Maltese: 51368 Leverkusen
English: Iloprost, the active substance of Ventavis, is a synthetic prostacyclin analogue.
Maltese: Iloprost, is-sustanza attiva ta' Ventavis, huwa analogu sintetiku ta' prostacycline.
English: Bayer Hispania S.L.
Maltese: España Bayer Hispania S.L.
English: − Severe arrhythmias.
Maltese: - Arritmiji severi.
English: • 300 ampoules.
Maltese: • 300 ampulla.
English: Bronchospasm* (see section 4.4) / Wheezing
Maltese: Bronkospażmu* (ara sezzjoni 4.4) /Tħarħir
English: 2.5 microgram 5 microgram
Maltese: 2.5 mikrogrammi 5 mikrogrammi
English: • The active substance is iloprost.
Maltese: • Is-sustanza attiva hi iloprost.
English: Local tolerance, contact sensitising and antigenicity potential
Maltese: Tolleranza lokali, sensibilizzazzjoni għall-kuntatt u potenzjal ta' antiġenetiċità
English: Ventavis contains ethanol
Maltese: Ventavis fih ethanol
English: (e.g. active peptic ulcers, trauma, intracranial haemorrhage).
Maltese: ulċeri attivi fl-istonku, trawma, emorraġija intrakranjali).
English: Control disc
Maltese: Disk talkontroll
English: Not known: frequency cannot be estimated from the available data.
Maltese: Mhux magħrufa: frekwenza ma tistax tiġi stmata minn data disponibbli.
English: • 90 (3x30) ampoules
Maltese: • 90 (3x30) ampulla
English: Gastrointestinal disorders Nausea
Maltese: Disturbi gastrointestinali
English: • 300 (10x30) ampoules.
Maltese: • 300 (10x30) ampulla.
English: Each ml contains 1.62 mg ethanol 96% (equivalent to 1.50 mg ethanol).
Maltese: Kull ml fih 1.62 mg ta' 96% ethanol (ekwivalenti għal 1.50 mg ethanol).
English: Breelib nebuliser:
Maltese: Nebulizzatur Breelib:
English: Date of first authorisation: 16 September 2003 Date of latest renewal: 26 August 2013
Maltese: Data tal-aħħar tiġdid: 26 ta' Awwissu 2013
English: In clinical trials peripheral oedema was reported in 12.2% of patients on iloprost and 16.2% of patients on placebo.
Maltese: Fil-provi kliniċi edima periferali kienet irrappurtata fi 12.2% tal-pazjenti fuq iloprost u 16.2% talpazjenti fuq plaċebo.
English: • 168 (4x42) ampoules
Maltese: • 168 (4x42) ampulla
English: Each ml contains 0.81 mg ethanol 96% (equivalent to 0.75 mg ethanol)
Maltese: Kull ml fih 0.81 mg ta' 96% ethanol (ekwivalenti għal 0.75 mg ethanol)
English: The following pharmacological effects have been observed in vitro:
Maltese: Dawn l-effetti farmakoloġiċi li ġejjin kienu osservati in vitro:
English: • 90 ampoules
Maltese: • 90 ampulla
English: • 30 ampoules
Maltese: • 30 ampulla
English: Serum glucose levels
Maltese: Livelli ta' glucose fis-serum
English: Ventavis is used to treat moderate cases of primary pulmonary hypertension (PPH) in adult patients.
Maltese: Ventavis jintuża biex jittratta każijiet moderati ta' pressjoni pulmonari għolja primarja (PPH primary pulmonary hypertension) f'pazjenti adulti.
English: Bayer, spol.
Maltese: Slovenská republika Bayer, spol.
English: Bayer AB Tel: +46 (0) 8 580 223 00
Maltese: Tel: +46 (0) 8 580 223 00
English: Tachycardia Palpitations
Maltese: Takikardija Palpitazzjonijiet
English: The rate of responders to iloprost was 16.8% (17/101) and the rate of responders in the placebo group was 4.9% (5/102) (p=0.007).
Maltese: Ir-rata ta' dawk li rrispondew għal iloprost kienet ta' 16.8% (17/101) u rrata ta' dawk li rrispondew fil-grupp tal-plaċebo kienet ta' 4.9% (5/102) (p=0.007).
English: Immune system disorders
Maltese: Distrubi fis-sistema immuni
English: m. b. H. Tel: +43-(0)1-711 46-0
Maltese: Tel: +43-(0)1-711 46-0
English: “How to use Ventavis”).
Maltese: Ventavis”).
English: Τηλ: +30 210 61 87 500
Maltese: Bayer Ελλάς ΑΒΕΕ Τηλ: +30 210 61 87 500
English: One inhalation session with Breelib will usually last about 3 minutes.
Maltese: Sessjoni ta' teħid man-nifs waħda bi Breelib normalment iddum madwar 3 minuti.
English: 30 AMPOULES WITH 2 ML 90 AMPOULES WITH 2 ML 90 (3 x 30) AMPOULES WITH 2 ML 100 AMPOULES WITH 2 ML 300 AMPOULES WITH 2 ML 300 (10 x 30) AMPOULES WITH 2 ML
Maltese: 30 AMPULLA B'2 ML 90 AMPULLA B'2 ML 90 (3 x 30) AMPULLA B'2 ML 100 AMPULLA B'2 ML 300 AMPULLA B'2 ML 300 (10 x 30) AMPULLA B'2 ML
English: In the iloprost group the NYHA class was improved in 26% of patients (placebo: 15%) (p = 0.032), unchanged in 67.7% of patients (placebo: 76%) and deteriorated in 6.3% of patients (placebo: 9%).
Maltese: Fil-grupp ta' iloprost il-klassi ta' l-NYHA marret għall-aħjar f'26% tal-pazjenti (plaċebo 15%) (p=0.032), ma tbiddlitx f'67.7% tal-pazjenti (plaċebo: 76%) u marret għall-agħar f'6.3% talpazjenti (plaċebo: 9%).
English: EU/1/03/255/001 EU/1/03/255/002 EU/1/03/255/003 EU/1/03/255/004 EU/1/03/255/005 EU/1/03/255/006 EU/1/03/255/007 EU/1/03/255/008 EU/1/03/255/011 EU/1/03/255/013
Maltese: EU/1/03/255/005 EU/1/03/255/006 EU/1/03/255/007 EU/1/03/255/008 EU/1/03/255/011 EU/1/03/255/013
English: • 100 ampoules
Maltese: • 100 ampulla
English: Patients with a creatinine clearance of ≤30 ml/min were not investigated in the clinical trials.
Maltese: Pazjenti bi tneħħija tal-kreatinina ta' ≤30 ml/min ma kinux investigati fil-provi kliniċi.
English: I-Neb AAD nebuliser:
Maltese: Nebulizzatur I-Neb AAD:
English: Multipacks containing:
Maltese: Pakketti multipli fihom:
English: Pain in jaw/trismus
Maltese: Uġigħ fixxedaq/trismus
English: • swelling of the limbs (peripheral oedema)
Maltese: • nefħa fid-dirgħajn/riġlejn (edima periferali)
English: Bayer OÜ Tel: +372 655 8565
Maltese: Tel: +372 655 8565
English: Other possible effects
Maltese: Effetti oħra possibbli
English: The active substance of Ventavis is iloprost.
Maltese: Is-sustanza attiva ta' Ventavis hija iloporst.
English: Τηλ: +357 22 48 38 58
Maltese: NOVAGEM Limited Τηλ: +357 22 48 38 58
English: Ventavis inhalation might entail the risk of inducing bronchospasm, especially in patients with bronchial hyperactivity (see section 4.8).
Maltese: Teħid man-nifs ta'Ventavis jista' jwassal għal riskju ta' induzzjoni ta' bronkospażmu, speċjalment f'pazjenti b'attività eċċessiva tal-bronki (ara sezzjoni 4.8).
English: Bayer B.V. Tel: +31-(0)297-28 06 66
Maltese: Tel: +31-(0)297-28 06 66
English: Bayer A/S Tlf: +45-45 23 50 00
Maltese: Tlf: +45-45 23 50 00
English: Vasodilatation Flushing
Maltese: Vasodilatazzjoni Fwawar
English: Bayer Austria Ges.
Maltese: Österreich Bayer Austria Ges. m. b. H.
English: Multipack containing 90 (3x30) or 300 (10x30) ampoules.
Maltese: Pakkett multiplu li fih 90 (3x30) jew 300 (10x30) ampulla.
English: In vitro (bacterial, mammalian cells, human lymphocytes) and in vivo studies (micronucleus test) for genotoxic effects have not produced any evidence for a mutagenic potential.
Maltese: Studji in vitro (fuq batterja, ċelluli mammiferi, limfoċiti umani) u in vivo (test tal-mikronukleu) dwar effetti ġenotossiċi ma pproduċew l-ebda evidenza ta' potenzjal mutaġeniku.
English: Limited data are available on the use of the Breelib nebuliser.
Maltese: Hemm data limitata disponibbli dwar l-użu tan-nebulizzatur Breelib.
English: Tetranor-iloprost is pharmacologically inactive as shown in animal experiments.
Maltese: Tetranor ijloprost huwa farmakoloġikament inattiv kif intwera f'esperimenti fuq l-annimali.
English: Breelib is a small handheld, battery-powered, breath activated, vibrating mesh technology system.
Maltese: Breelib huwa sistema żgħira li tinżamm fl-idejn, li taħdem permezz ta' batteriji, attivata min-nifs, tattip vibrating mesh technology (teknoloġija ta' xibka li tivvibra).
English: Bayer plc Tel: +44 (0)118 206 3000
Maltese: Tel: +44 (0)118 206 3000
English: A mean increase in the 6-minute walk test of 44.7 metres from a baseline mean value of 329 metres vs. a change of -7.4 metres from a baseline mean value of 324 metres in the placebo group (no data imputation for death or missing values) was observed in the subgroup of 49 patients with primary pulmonary hypertension receiving treatment of inhaled iloprost for 12 weeks (46 patients in the placebo group).
Maltese: Żjieda medja ta' 44.7 metri fit-test ta' mixja ta' 6 minuti mill-valur medju fil-linja bażi ta' 329 metru vs. bidla ta' -7.4 metri mill-valur medju fil-linja bażi ta' 324 metru fil-grupp tal-plaċebo (l-ebda imputazzjoni ta' informazzjoni għal mewt jew valuri neqsin) kienet osservata fis-sotto-grupp ta' 49 pazjent bi pressjoni pulmonari għolja primarja li kienu qed jirċievu t-trattament ta' teħid man-nifs ta' iloprost għal 12-il ġimgħa (46 pazjent fil-grupp tal-plaċebo).
English: Pharmacokinetics after use with different nebulisers
Maltese: Farmakokinetika wara l-użu b'nebulizzaturi differenti
English: • pain in jaw/spasm of the jaw muscles (trismus)
Maltese: • uġigħ fix-xedaq/spażmu fil-muskoli tax-xedaq (trismus)
English: Poligono Industrial Santa Rosa s/n 28806 Alcalá de Henares Madrid
Maltese: 28806 Alcalá de Henares
English: • Breelib nebuliser
Maltese: • Nebulizzatur Breelib
English: The main metabolite is tetranor-iloprost, which is found in the urine in free and conjugated form.
Maltese: Il-metabolu prinċipali huwa tetranor-iloprost, li jinstab fl-awrina fil-forma libera u fil-forma kkonjugata.
English: Multipack: 300 (10 x 30) ampoules with 2 ml.
Maltese: Pakkett multiplu: 300 (10 x 30) ampulla b'2 ml.
English: The measured MMAD of the aerosol droplets was 2.6 micrometres.
Maltese: LMMAD imkejjel tal-qtar tal-aerosol kien ta' 2.6 mikrometri.
English: SIA Bayer Tel: +371 67 84 55 63
Maltese: Tel: +371 67 84 55 63
English: Genotoxic potential, tumourigenicity
Maltese: Potenzjal ġenotossiku, tumoroġenetiċità
English: The total clearance of iloprost is about 20 ml/kg/min, which indicates extrahepatic contribution to the metabolism of iloprost.
Maltese: It-tneħħija totali ta' iloprost hija madwar 20 ml/kg/min, li tindika kontribuzzjoni ekstra-epatika għall-metaboliżmu ta' iloprost.
English: • Ventavis 10 microgram/ml:
Maltese: • Ventavis 10 mikrogrammi/ml:
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excluding heparin, ATC code: B01AC11
Maltese: Sustanzi antitrombotiċi, inibituri tal-aggregazzjoni tal-plejtlits minbarra l-eparina, Kodiċi ATC:
English: A specific antidote is not known.
Maltese: Antidotu speċifiku mhux magħruf.
English: Room ventilation
Maltese: Ventilazzjoni tal-kamra
English: Excipients: trometamol, ethanol 96%, sodium chloride, hydrochloric acid (for pH adjustment), water for injections.
Maltese: Eċċipjenti: trometamol, ethanol 96%, sodium chloride, hydrochloric acid (għall-aġġustament tal-pH), ilma għall injezzjonijiet.
English: • Ventavis 20 microgram/ml:
Maltese: • Ventavis 20 mikrogramma/ml:
English: Gender Gender is not of clinical relevance to the pharmacokinetics of iloprost.
Maltese: Sess Is-sess mhux ta' rilevanza klinika għall-farmakokinetika ta' iloprost.
English: Contents of the pack and other information What Ventavis contains:
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Ventavis:
English: • Low blood pressure (hypotension)
Maltese: • Pressjoni baxxa (ipotensjoni).
English: Bayer s.r.o.
Maltese: Česká republika Bayer s.r.o.
English: Multipack: 168 (4 x 42) ampoules with 1 ml.
Maltese: Pakkett multiplu: 168 (4 x 42) ampulla b'1 ml.
English: Part of a multipack containing 90 ampoules with 2 ml.
Maltese: Parti minn pakkett multiplu li fih 90 ampulla ta' 2 ml.
English: Part of a multipack containing 300 ampoules with 2 ml.
Maltese: Parti minn pakkett multiplu li fih 300 ampulla ta' 2 ml.
English: Reproductive toxicology
Maltese: Tossikoloġija fir-riproduzzjoni
English: Peripheral oedema is a very common symptom of the disease itself, but can also occur under therapy.
Maltese: Edima periferali hija sintomu komuni ħafna tal-marda nnifisha, iżda tista' sseħħ ukoll meta tkun qed tingħata terapija.
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: EU/1/03/255/009 EU/1/03/255/010 EU/1/03/255/012 EU/1/03/255/014
Maltese: EU/1/03/255/012 EU/1/03/255/014
English: 168 (4 x 42) AMPOULES WITH 1 ML
Maltese: 168 (4 x 42) AMPULLA B'1 ML
English: • Medicines that thin the blood or inhibit blood clotting, this includes acetylsalicylic acid (ASA - a compound found in many medicines that lower fever and relieve pain), heparin, coumarin-type anticoagulants, such as warfarin or phenprocoumon, non-steroidal anti-inflammatory drugs, non-selective phosphodiesterase inhibitors, such as pentoxifylline, selective phosphodiesterase 3 (PDE 3) inhibitors, such as cilostazol or anagrelide, ticlopidine, clopidogrel, glycoprotein IIb/IIIa antagonists, such as o abciximab, o eptifibatide, o tirofiban, defibrotide.
Maltese: - heparin, - sustanzi kontra l-koagulazzjoni tad-demm tat-tip coumarin, bħal - warfarin jew phenprocoumon - mediċini anti-infjammatorji mhux sterojdi, - inibituri mhux selettivi ta' phosphodiesterase, bħal pentoxifylline, - inibituri selettivi ta' phosphodiesterase 3 (PDE 3), bħal cilostazol jew anagrelide, - ticlopidine, - clopidogrel, - antagonisti ta' glycoprotein IIb/IIIa, bħal o abciximab,
English: Dyspnoea Pharyngolaryngeal pain
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni għan-nebulizzatur.
English: The measured MMAD of the aerosol droplets was 2.1 micrometres.
Maltese: L-MMAD imkejjel tal-qtar tal-aerosol kien 2.1 mikrometri.
English: Total plasma protein binding of iloprost is concentration-independent in the range of 30 to 3,000 picogram/ml and amounts to approximately 60%, of which 75% is due to albumin binding.
Maltese: It-total ta' twaħħil ta' iloprost mal-proteini fil-plażma huwa indipendenti mill-konċentrazzjoni b'valuri ta' bejn 30 u 3,000 pikogramma/ml u jammonta għal madwar 60%, li minnhom 75% huwa minħabba t-twaħħil ma' l-albumina.
English: The Mass Median Aerodynamic Diameter (MMAD) of the aerosol measured using I-Neb nebulising systems equipped with power level 10 disc was similar between Ventavis 20 microgram/ml (golden programme) and Ventavis 10 microgram/ml (purple programme) nebuliser solutions (i.e.: around 2 micrometres) but with faster delivery when using Ventavis 20 microgram/ml.
Maltese: Id-Dijametru tal-Massa Erodinamika Medjana (MMAD - Mass Median Aerodynamic Diameter) tal-aerosol imkejjel permezz ta' sistemi nebulizzanti I-Neb mgħammra b'disk b'livell ta' qawwa 10 kien simili bejn Ventavis 20 mikrogramma/ml (programm lewn id-deheb) u Ventavis 10 mikrogrammi/ml (programm vjola) soluzzjonijiet għan-nebulizzatur (jiġifieri: madwar
English: A cautious initial dose titration using dosing intervals of 3-4 hours is recommended (see section 4.2).
Maltese: Hija rakkomandata titrazzjoni b'attenzjoni tad-doża tal-bidu bl-użu ta' intervalli ta' bejn id-doża ta' 3-4 sigħat (ara sezzjoni 4.2).
English: Ventavis 10 microgram/ml (1 ml ampoule) and Ventavis 20 microgram/ml nebuliser solution
Maltese: Ventavis 10 mikrogrammi/ml (ampulla ta' 1 ml) u Ventavis 20 mikrogramma/ml soluzzjoni għannebulizzatur
English: The frequencies of adverse reactions are defined as very common (≥1/10) and common (≥1/100 to <1/10).
Maltese: Il-frekwenzi tar-reazzjonijiet avversi huma definiti bħala komuni ħafna (≥1/10) u komuni (≥1/100 sa <1/10).
English: Pharmacokinetics of iloprost were investigated in a randomised, crossover study with 27 patients, stable on Ventavis 10 microgram/ml inhaled with I-Neb, following inhalation of single doses of 2.5 or 5 microgram iloprost using the Breelib or the I-Neb AAD nebuliser.
Maltese: Il-farmakokinetika ta' iloprost kienet investigata fi studju randomised u crossover b'27 pazjent stabbli fuq Ventavis 10 mikrogrammi/ml meħud man-nifs b'I-Neb, wara t-teħid man-nifs ta' dożi waħdanin ta' 2.5 jew 5 mikrogrammi iloprost bl-użu tan-nebulizzatur Breelib jew I-Neb AAD.
English: Elderly Pharmacokinetics in elderly patients have not been investigated.
Maltese: Anzjani Il-farmakokinetika ma ġietx investigata f'pazjenti anzjani.
English: Ampoules with 1 ml nebuliser solution (for the use of Breelib or I-Neb AAD):
Maltese: Ampulli b'soluzzjoni għan-nebulizzatur ta' 1 ml (biex jintużaw ma' Breelib jew I-Neb AAD):
English: • or other inhibitors of platelet aggregation, such as acetylsalicylic acid, non-steroidal anti-inflammatory medicinal products, non-selective phosphodiesterase inhibitors like pentoxifylline, selective phosphodiesterase 3 (PDE3) inhibitors like cilostazol or anagrelide, ticlopidine, clopidogrel, glycoprotein IIb/IIIa antagonists, like o abciximab, o eptifibatide, o tirofiban, defibrotide.
Maltese: inibituri selettivi ta' phosphodiesterase 3 (PDE3) bħal cilostazol jew anagrelide, ticlopidine, clopidogrel, antagonisti tal-glikoproteina IIb/IIIa, bħal o abciximab, o eptifibatide, o tirofiban,
English: Syncope§ (see section 4.4) Hypotension*
Maltese: (ara sezzjoni 4.4) Pressjoni baxxa*
English: • Venta-Neb nebuliser (2 ml ampoule with white and pink rings)
Maltese: • Nebulizzatur Venta-Neb (ampulla ta' 2 ml bi ċrieki ta' lewn abjad u roża)
English: 90 ampoules with 2 ml.
Maltese: 90 ampulla b'2 ml.
English: A randomised, double-blind, multi-centre, placebo-controlled phase III trial (study RRA02997) has been conducted in 203 adult patients (inhaled iloprost at the concentration of 10 microgram/ml: N=101; placebo n=102) with stable pulmonary hypertension.
Maltese: III randomised, multi-ċentrika, fejn la l-individwu u lanqas l-investigatur ma jkunu jafu xi trattament ikun qed jingħata, kkontrollata bil-plaċebo (studju RRA02997) saret f'203 pazjent adult
English: 300 ampoules with 2 ml.
Maltese: 300 ampulla b'2 ml.
English: • 1 ml ampoules for use with Breelib or I-Neb nebulisers:
Maltese: • Ampulli ta' 1 ml għall-użu man-nebulizzaturi Breelib jew I-Neb:
English: Following inhalation of these doses with the Breelib the maximum plasma concentrations (Cmax) and systemic exposures (AUC (0-tlast)) increased dose-proportionally.
Maltese: Wara t-teħid man-nifs ta' dawn id-dożi bi Breelib il-konċentrazzjonijiet massimi fil-plażma (Cmax) u lesponimenti sistemiċi (AUC (0-tl-aħħar)) żdiedu b'mod proporzjonali mad-doża.
English: Ventavis is intended for inhalation use by nebulisation.
Maltese: Ventavis huwa maħsub biex jinġibed man-nifs permezz ta' nebulizzazzjoni.
English: Ventavis 10 microgram/ml
Maltese: Ventavis 10 mikrogrammi/ml
English: Ventavis 20 microgram/ml
Maltese: Ventavis 20 mikrogramma/ml
English: These concentrations decline with half-lives between approximately 5 and 25 minutes.
Maltese: Dawn il-konċentrazzjonijiet jonqsu b'half-lives madwar bejn 5 u 25 minuta.
English: How to store Ventavis
Maltese: Tużax Ventavis
English: 42 ampoules with 1 ml.
Maltese: 42 ampulla b'1 ml.
English: Ampoules with 2 ml nebuliser solution (for the use of Venta-Neb):
Maltese: Ampulli b'soluzzjoni għan-nebulizzatur ta' 2 ml (biex jintużaw ma' Venta-Neb):
English: 108 of the patients included were diagnosed with primary pulmonary hypertension, 95 were diagnosed with secondary pulmonary hypertension of which 56 were associated with chronic thromboembolic disease, 34 with connective tissue disease (including CREST and scleroderma) and 4 were considered appetite suppressant medicinal product related.
Maltese: pressjoni pulmonari għolja primarja, 95 kellhom dijanjosi ta' pressjoni pulmonari għolja sekondarja li minnhom 56 kienu assoċjati ma' mard tromboemboliku kroniku, 34 ma' mard tat-tessut konnettiv (li jinkludi CREST u skleroderma) u 4 kienu kkunsidrati li kellhom trażżin fl-aptit konness mal-prodott mediċinali.