qanastek/EMEA-V3 huggingface dataset:
5 Iloprost can inhibit platelet function and its use with anticoagulants (such as heparin, coumarin-type anticoagulants) or other inhibitors of platelet aggregation (such as acetylsalicylic acid, non-steroidal anti-inflammatory medicinal products, ticlopidine, clopidogrel and glycoprotein IIb/ IIIa antagonists: abciximab, eptifibatide and tirofiban) may increase the risk of bleeding.
Iloprost jista ’ jinibixxi l- funzjoni tal- plejtlets u l- użu tiegħu ma ’ mediċini kontra t- tagħqid tad- demm (bħall- eparina, mediċina kontra t- tagħqid tad- demm tat- tip kumarin) jew inibituri oħra ta ’ l - aggregazzjoni tal- plejtlets (bħal acetyl salicylic acid, mediċini mhux sterojdi ta ’ kontra l - infjammazzjoni, ticlopidine, clopidogrel u antagonisti tal- glikoproteina IIb/ IIIa: abciximab, eptifibatide u tirofiban) jistgħu jżidu r- riskju ta ’ fsad ta ’ demm.
A careful monitoring of the patients taking anticoagulants according to common medical practice is recommended.
Hija rakkomandata osservazzjoni b’ attenzjoni tal- pazjenti li qed jieħdu mediċini kontra t- tagħqid tad- demm skond il- prattika medika komuni.
The concomitant use of other platelet inhibitors should be avoided in patients taking anticoagulants.
L- użu flimkien ta ’ inibituri oħra tal- plejtlets għandu jkun evitat f’ pazjenti li qed jieħdu mediċina kontra t- tagħqid tad- demm.
Intravenous infusion of iloprost has no effect either on the pharmacokinetics of multiple oral doses of digoxin or on the pharmacokinetics of co-administered tissue plasminogen activator (t-PA) in patients.
Infużjoni ġol- vini ta ’ iloprost m’ għandha l- ebda effett, la fuq il- farmakokinetiċi ta ’ dożi multipli mill - ħalq ta ’ digoxin u lanqas fuq il- farmakokinetika ta ’ l- għotja flimkien ma ’ l- attivatur ta ’ plasminogen fit- tessut (t- PA) f’ pazjenti.
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 have to be expected.
Għalkemm studji kliniċi ma sarux, studji in vitro li nvestigaw il- potenzjal inibitorju ta ’ iloprost fuq l- attività ta ’ l- enzimi taċ- ċitokromju P450 wrew li m’ għandu jkun mistenni l - ebda inibizzjoni rilevanti fuq il- metaboliżmu tal- mediċina permezz ta ’ dawn l- enzimi minn iloprost.
There are no adequate data from the use of Ventavis in pregnant women.
M’ hemmx informazzjoni xierqa dwar l- użu ta ’ Ventavis f’ nisa tqal.
Animal studies have shown reproductive toxicity (see section 5.3).
Studji fuq annimali wrew tossiċità riproduttiva (ara sezzjoni 5. 3).
Ventavis is contra- indicated during pregnancy (see section 4.3).
Ventavis huwa kontra- indikat waqt it- tqala (ara sezzjoni 4. 3).
Women of child-bearing potential should use effective contraceptive measures during treatment.
Nisa b’ potenzjal ta ’ tqala għandhom jużaw miżuri kontraċettivi effettivi waqt il- kura.
It is not known whether Ventavis enters the breast milk.
Mhux magħruf jekk Ventavis jgħaddix fil- ħalib tas- sider.
The medicinal product must not be administered to breast feeding mothers (see section 4.3).
Il- prodott mediċinali m’ għandux jingħata lill- ommijiet li qed ireddgħu (ara sezzjoni 4. 3).
Care should be exercised during initiation of therapy until any effects on the individual have been determined.
Għandha tingħata attenzjoni waqt il- bidu tal- kura sakemm ikun iddeterminat x’ effett għandha il - mediċina fuq l- individwu.
In patients experiencing hypotensive symptoms such as dizziness, the abilityto drive or operate machines may be affected.
F’ pazjenti li qed ikollhom sintomi ta ’ pressjoni baxxa, bħal sturdament, il - ħila biex issuq u biex tuża l- magni tista ’ tkun effettwata.
In addition to local effects resulting from administration of iloprost by inhalation such as increased cough, adverse reactions with iloprost are related to the pharmacological properties of prostacyclins.
Flimkien ma ’ l- effetti lokali li jirriżultaw mill- għotja ta ’ iloprost bil- ġbid tan- nifs għal ġol- pulmuni, bħal żjieda fis- sogħla, effetti avversi b’ iloprost huma relatati mal- karatteristiċi farmakoloġiċi tal - prostacyclins.
The most common adverse reactions seen in clinical trials include vasodilatation, hypotension, headache and increased cough.
L- aktar reazzjonijiet avversi komuni li dehru fi provi kliniċi inkludew vasodilatazzjoni, pressjoni baxxa, uġigħ ta ’ ras u żieda fis- sogħla.
Frequencies of adverse reactions are reported as follows: very common ≥ 1/ 10; common ≥ 1/ 100 to < 1/ 10; uncommon ≥ 1/ 1,000 and < 1/ 100; rare ≥ 1/ 10,000 to < 1/ 1,000; very rare < 1/ 10,000.
Il- frekwenzi tar- reazzjonijiet avversi huma rrappurtati kif ġej: komuni ħafna ≥ 1/ 10; komuni ≥ 1/ 100 sa < 1/ 10; mhux komuni ≥ 1/ 1, 000 u < 1/ 100; rari ≥ 1/ 10, 000 sa < 1/ 1, 000; rari ħafna < 1/ 10, 000.
The table below reports adverse reactions by MedDRA system organ classes (MedDRA SOCs).
It- tabella t’ hawn taħt tirrapporta r- reazzjonijiet avversi skond is- sistema tal- klassifika ta ’ l- organi MedDRA (MedDRA SOCs).
The incidences are based on clinical trial data.
L- inċidenzi huma bbażati fuq tagħrif ta ’ provi kliniċi.
6 Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà tagħhom.
System organ class
6 Sistema tal- klassifika ta ’ l- organi Komuni hafna
Common
komuni
Nervous system disorders
Uġigħ ta ’ ras Disturbi fis- sistema nervuża Disturbi vaskulari
Headache
Vasodilatazzjoni,
Vascular disorders
Sinkope,
Vasodilatation, Hypotension
Disturbi respiratorji, toraċiċi u medjastinali
Syncope, Dizziness related to hypotension
Pressjoni baxxa Żieda fis- sogħla
Respiratory, thoracic and mediastinal disorders
Sturdament relatat ma ’ pressjoni baxxa
Pain in jaw/ trismus
Uġigħ fix- xedaq/ trismus
Syncope is a common symptom of the disease itself, but can also occur under therapy.
Sinkope huwa sintomu komuni tal- marda nnifisha, iżda jista ’ jseħħ ukoll meta tkun qed tingħata terapija.
The increased occurrence of syncopes can be related to the deterioration of the disease or insufficient effectiveness of the product (see section 4.4).
Iż- żieda fl- okkorrenza ta ’ sinkopi tista ’ tkun relatata mad- deterjorazzjoni tal- marda jew effettività insuffiċjenti tal- prodott (ara sezzjoni 4. 4).
Peripheral oedema is a very common symptom of the disease itself, but can also occur under therapy.
Edima periferali hija sintomu komuni ħafna tal- marda nnifisha, iżda tista ’ sseħħ ukoll meta tkun qed tingħata terapija.
The occurrence of peripheral oedema can be related to the deterioration of the disease or insufficient effectiveness of the product.
L- okkorrenza ta ’ edima periferali tista ’ tkun relatata mad- deterjorazzjoni tal- marda jew effettività insuffiċjenti tal- prodott.
Bleeding events (mostly haematoma) were common as expected in this patient population with a high proportion of patients taking anticoagulant co-medication.
Episodji ta ’ fsad ta ’ demm (l- aktar ematoma) kienu komuni kif mistenni f’ din il- popolazzjoni ta ’ pazjenti bi proporzjon għoli li kienu qed jieħdu (flimkien ma ’ Ventavis) mediċini kontra t- tagħqid tad- demm.
The frequency of bleeding events did not differ between iloprost and placebo-treated patients.
Il- frekwenza ta ’ episodji ta ’ fsad ta ’ demm ma ’ varjatx bejn pazjenti kkurati b’ iloprost u dawk kkurati bil- plaċebo.
Post marketing experience
Esperjenza ta ’ wara t- tqegħid fis- suq
Vomiting, nausea, diarrhoea and dyspnoea have been reported in association with Ventavis inhalation.
Rimettar, tqalligħ, dijarea u qtugħ ta ’ nifs ġew irrappurtati f’ assoċjazzjoni ma ’ Ventavis meħud man - nifs.
Bronchospasm and wheezing have also been reported in patients treated with Ventavis inhalation (see section 4.4 Special warnings and precautions for use).
Bronkospażmu u tħarħir ġew irrappurtati wkoll f’ pazjenti kkurati b’ Ventavis meħud man- nifs (ara sezzjoni 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu).
Adverse events in healthy volunteers
Avvenimenti avversi f’ voluntiera f’ saħħithom
In a randomized placebo-controlled study in 160 healthy volunteers, inhaled doses of iloprost solution were given either with a fixed dose of 2.5 micrograms iloprost 6 times daily (total daily dose of 15 micrograms), or beginning with 5.0 microgram and increasing up to 20 micrograms, or the highest tolerated dose for a total of 6 dose inhalations (total daily dose of 70 micrograms).
Fi studju randomized ugwalment ikkontrollat bil- plaċebo li sar fuq 160 voluntiera f’ saħħithom, dożi ta ’ soluzzjoni ta ’ iloprost miġbuda man- nifs ingħataw jew ma ’ doża fissa ta ’ 2. 5 mikrogrammi ta ’ iloprost 6 darbiet kuljum (doża totali kuljum ta ’ 15 – il mikrogramma), jew b’ doża li tibda b’ 5. 0 mikrogrammi u tiżdied sa 20 mikrogramma jew l- ogħla doża ttollerata għal total ta ’ 6 dożi miġbuda man- nifs (doża totali kuljum ta ’ 70 mikrogramma),
In the fixed dose group of 2.5 micrograms per inhalation chest pain, or chest discomfort (32.5%), pharyngolaryngeal pain, or throat irritation (22.5%) and nausea (7.5%) – (all non-serious and mild in intensity) – occurred more frequently in comparison with the adverse events obtained from the placebo controlled phase II and III studies in patients with doses of 2.5 micrograms or 5 micrograms per inhalation.
Fil- grupp li kien qed jieħu doża fissa ta ’ 2. 5 mikrogrammi ma ’ kull ġbid man- nifs, uġigħ fis- sider li jgħaddi malajr jew skonfort fis- sider (32. 5%), uġigħ faringolarinġeali, jew irritazzjoni fil- griżmejn (22. 5%) u dardir (7. 5%) (kollha mhux serji u ħfief fl- intensità tagħhom) seħħew iktar ta ’ spiss meta mqabbla ma ’ l- avvenimenti avversi li nkisbu mill- istudji ta ’ fazi II u III li kienu kkontrollati bil - plaċebo f’ pazjenti li kienu qed jieħdu dożi ta ’ 2. 5 mikrogrammi jew 5 mikrogrammi ma ’ kull ġbid man- nifs.
Five volunteers were unable to increase the dose up to 20 micrograms per inhalation because of mild to moderate transient chest pain or chest discomfort, usually accompanied by headache, dizziness and nausea.
Ħames volontiera ma kienux kapaċi li jżidu d- doża sa 20 mikrogramma ma ’ kull ġbid man- nifs minħabba uġigħ fis- sider li jgħaddi malajr li kien minn ħafif sa moderat jew skonfort fis- sider, li normalment kienu akkompanjati minn uġigħ ta ’ ras, sturdament u dardir.
7 4.9 Overdose
7 4. 9 Doża eċċessiva
No case of overdose has been reported.
L- ebda każ ta ’ doża eċċessiva ma kien irrappurtat.
Hypotensive/ vasovagal reaction might be anticipated as well as headache, flushing, nausea, vomiting, and diarrhoea.
Reazzjoni ta ’ pressjoni baxxa / vasovagali tista ’ tkun mistennija kif ukoll uġigħ ta ’ ras, fwawar, dardir, rimettar, u dijareja.
• Therapy
• Terapija
A specific antidote is not known.
5.
Platelet aggregation inhibitors excluding heparin, ATC code:
Inibituri ta ’ l- aggregazzjoni tal- plejtlets minbarra l- eparina, Kodiċi ATC:
Iloprost, the active substance of Ventavis, is a synthetic prostacyclin analogue.
Iloprost, is- sustanza attiva ta ’ Ventavis, hija analogu sintetiku ta ’ prostacycline.
The following pharmacological effects have been observed in vitro:
Dawn l- effetti farmakoloġiċi li ġejjin kienu osservati in vitro:
• Inhibition of platelet aggregation, platelet adhesion and release reaction
• Inibizzjoni ta ’ l- aggregazzjoni tal- plejtlets, aderenza tal- plejtlets u reazzjoni tal- ħelsien
• Dilatation of arterioles and venules
• Dilatazzjoni ta ’ friegħi żgħar ta ’ l- arterji u l- vini
• Increase of capillary density and reduction of increased vascular permeability caused by mediators such as serotonin or histamine in the microcirculation
• Żjieda fid- densità tal- kapillari u tnaqqis fiż- żjieda tad- dħul u l- mogħdija ta ’ likwidu vaskulari kkawżata minn medjaturi bħal serotonina jew istamina fil- mikroċirkolazzjoni
• Stimulation of endogenous fibrinolytic potential
• Stimulazzjoni tal- potenzjal fibrinolitiku endoġenu
The pharmacological effects after inhalation of Ventavis are:
L- effetti farmakoloġiċi wara l- ġbid tan- nifs għal ġol- pulmuni ta ’ Ventavis huma:
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.
Twesigħ dirett tas- saff ta ’ l- arterji pulmonari jseħħ b’ titjib konsekuttiv sinifikanti tal- pressjoni ta ’ l - arterja pulmonari, tar- reżistenza vaskulari pulmonarja u tal- funzjoni tal- qalb kif ukoll tas- saturazzjoni mħallat ta ’ ossiġnu fil- vini.
No clinical trial data are available comparing directly in intra-patient observations the acute haemodynamic response after intravenous to that after inhaled iloprost.
L- ebda informazzjoni dwar provi kliniċi m’ hi disponibbli li tqabbel direttament, permezz ta ’ osservazzjonijiet fil- pazjent stess, ir- rispons emodinamiku akut wara l- għotja ġol- vini ta ’ iloprost ma ’ dak wara li iloprost ikun miġbud man- nifs.
The haemodynamics observed suggest an acute response with preferential effect of inhaled treatment on the pulmonary vessels.
L- emodinamika osservata tissuġġerixxi rispons akut b’ effett preferenzjali tal- kura permezz ta ’ ġbid man- nifs fuq il- vini u arterji pulmonari.
The pulmonary vasodilatory effect of each single inhalation levels off within one to two hours.
L- effett ta ’ vasodilatazzjoni pulmonari kkawżata b ’ kull ġibda tan- nifs għal ġol- pulmuni, jispiċċa minn siegħa sa sagħtejn wara.
However, the predictive value of these acute haemodynamic data are considered to be of limited value as acute response does not in all cases correlate with long-term benefit of treatment with inhaled iloprost.
Madankollu, il- valur imbassar ta ’ din l- informazzjoni emodinamika akuta huwa kkunsidrat li għandu valur limitat, billi r- rispons akut mhux assoċjat fil- każi kollha ma ’ benefiċċju fit - tul tal- kura b’ iloprost miġbud man- nifs.
• Efficacy in adult patients with pulmonary hypertension
• Effikaċja f’ pazjenti adulti bi pressjoni pulmonari għolja
8 A randomised, double-blind, multi-centre, placebo-controlled phase III trial (study RRA02997) has been conducted in 203 adult patients (inhaled iloprost:
Prova ta ’ fażi III b’ pazjenti magħżula bl- addoċċ, multi- ċentriku, fejn la s- suġġett u lanqas l - 8 investigatur ma jkun jafu x’ kura ikun qed jirċievi, ikkontrollat bil- plaċebo (studju RRA02997) sar f’ 203 pazjent adult (iloprost miġbud man- nifs:
N=101; placebo n=102) with stable pulmonary hypertension.
N=101; plaċebo n=102) bi pressjoni pulmonari għolja stabbli.
Inhaled iloprost (or placebo) was added to patients' current therapy, which could include a combination of anticoagulants, vasodilators (e. g. calcium channel blockers), diuretics, oxygen, and digitalis, but not PGI2 (prostacyclin or its analogues).
Iloprost miġbud man- nifs (jew plaċebo) kien miżjud mal- kura eżistenti tal- pazjenti, li seta ’ jinkludi taħlita ta ’ mediċini kontra t- tagħqid tad- demm, mediċini li jwessgħu l- arterji u l- vini (eż. blokkaturi tal- kanal tal- kalċju), dijuretiċi, ossiġnu, u digitalis, imma mhux PGI2 (prostacycline jew analogi tagħha).
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 drug related.
108 mill- pazjenti inklużi instab li kienu jbatgħu bi pressjoni pulmonari għolja primarja, 95 instab li kienu jbatgħu bi 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- mediċina.
The baseline 6-minute walk test values reflected a moderate exercise limitation: in the iloprost group the mean was 332 meters (median value:
Il- valuri tat- test ta ’ linja bażi ta ’ mixja ta ’ 6 minuti rriflettew limitazzjoni moderata fl- eżerċizzju: fil- grupp b’ iloprost il- medja kienet ta ’ 332 metru (valur medjan:
340 meters) and in the placebo group the mean was 315 meters (median value:
340 metru) u fil- grupp tal- plaċebo l- medja kienet ta ’ 315 metru (valur medjan:
321 meters).
321 metru).
In the iloprost group, the median daily inhaled dose was 30 micrograms (range 12.5 to 45 micrograms/ day).
Fil- grupp b’ iloprost, il- medjan tad- doża ta ’ kuljum miġbuda man - nifs kien ta ’ 30 mikrogramma( b’ varjazzjoni minn 12. 5 sa 45 mikrogramma/ kuljum).
The primary efficacy endpoint defined for this study, was a combined response criterion consisting of improvement in exercise capacity (6 minute walk test) at 12 weeks by at least 10% versus baseline, and improvement by at least one NYHA class at 12 weeks versus baseline, and no deterioration of pulmonary hypertension or death at any time before 12 weeks.
L- effikaċja primarja immirata għal dan l- istudju, kien kriterju ta ’ rispons imħallat li jikkonsisti f’ titjib fil- kapaċità ta ’ l- eżerċizzju (test ta ’ mixja ta ’ 6 minuti) wara 12- il ġimgħa b’ mill- inqas 10% kontra l- linja bażi, u titjib ta ’ mill- inqas klassi waħda ta ’ l- NYHA wara 12- il ġimgħa kontra l- linja bażi, u l- ebda deterjorament tal- pressjoni pulmonari għolja jew mewt fl- ebda żmien qabel 12- il ġimgħa.
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).
Ir- rata ta ’ dawk li rrispondew għal iloprost kienet ta ’ 16. 8% (17/ 101) u r- rata ta ’ dawk li rrispondew fil- grupp tal- plaċebo kienet ta ’ 4. 9% (5/ 102) (p=0. 007).
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 meters (-3.3 meters in the placebo group, no data imputation for death or missing values).
Fil- grupp ta ’ iloprost, il- medja ta ’ tibdil mill- linja bażi fid- distanza ta ’ mixja ta ’ 6 minuti wara 12- il ġimgħa kienet żjieda ta ’ 22 metru (- 3. 3 metri fil- grupp tal- plaċebo, l- ebda imputazzjoni ta ’ informazzjoni għal mewt jew valuri neqsin).
15%) (p = 0.032), unchanged in 67.7% of patients (placebo:
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%) and deteriorated in 6.3% of patients (placebo:
76%) u marret għall- agħar f’ 6. 3% tal- pazjenti (plaċebo:
Invasive haemodynamic parameters were assessed at baseline and after 12 weeks treatment.
Il- parametri invasivi emodinamiċi kienu mkejla fil- linja bażi u wara 12- il ġimgħa ta ’ kura.
A subgroup analysis showed that no treatment effect was observed as compared to placebo on the 6-minute walk test in the subgroup of patients with secondary pulmonary hypertension.
Analiżi ta ’ sotto- grupp uriet li l- ebda effett mill- kura ma kien osservat meta mqabbel mal- plaċebo fit - test ta ’ mixja ta ’ 6 minuti f’ sotto- grupp ta ’ pazjenti bi pressjoni pulmonari għolja sekondarja.
A mean increase in the 6-minute walk test of 44.7 meters from a baseline mean value of 329 meters vs. a change of -7.4 meters from a baseline mean value of 324 meters 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).
Żjieda medja ta ’ 44. 7 metri fit- test ta ’ mixja ta ’ 6 minuti mill- valur medju tal- linja bażi ta ’ 329 metru vs. bidla ta ’ - 7. 4 metri mill- valur medju tal- 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 l- kura tal- ġbid man- nifs ta ’ iloprost għal 12- il ġimgħa (46 pazjent fil- grupp tal- plaċebo).
No study has been performed with Ventavis in children with pulmonary hypertension.
L- ebda studju ma sar b ’ Ventavis fi tfal bi pressjoni pulmonari għolja.
• Absorption
• Assorbiment
When iloprost is administered via inhalation in patients with pulmonary hypertension (iloprost dose at the mouthpiece:
Meta iloprost jingħata permezz ta ’ ġbid tan- nifs għal ġol- pulmuni f’ pazjenti bi pressjoni pulmonari għolja (doża ta ’ iloprost fil- biċċa tal- ħalq:
5 micrograms), peak serum levels of 100 to 200 picograms/ ml were observed at the end of inhalation session.
5 mikrogrammi), livelli massimi fis- serum ta ’ 100 sa 200 pikogrammi/ ml kienu osservati fit- tmiem tas- sessjoni ta ’ ġbid għal ġol- pulmuni.
These levels decline with half-lives between approximately 5 and 25 minutes.
Dawn il- livelli jonqsu bin- nofs f’ madwar 5 u 25 minuta.
Within 30 minutes to 1 hour after the end of inhalation, iloprost is not detectable in the central compartment (limit of quantification 25 picograms/ ml).
Minn 30 minuta sa siegħa wara t- tmiem tal- ġbid tan- nifs għal ġol- pulmuni, iloprost ma jkunx imkejjel fil- kompartiment ċentrali (limitu ta ’ kwantifikazzjoni 25 pikogrammi/ ml).
• Distribution
• Distribuzzjoni
No studies performed following inhalation.
L- ebda studji ma saru wara l- ġbid tan- nifs għal ġol- pulmuni.
Following intravenous infusion, the apparent steady-state volume of distribution was 0.6 to 0.8 l/ kg in healthy subjects.
Wara infużjoni ġol- vini, il- volum apparenti ta ’ distribuzzjoni f’ stat stabbli kien minn 0. 6 sa 0. 8 l/ kg f’ suġġetti f’ saħħithom.
Total plasma protein binding of iloprost is concentration-independent in the range of 30 to 3000 picograms/ ml and amounts to approximately 60%, of which 75% is due to albumin binding.
It- total tat- tgħaqqid ta ’ iloprost ma ’ proteina tal- plażma huwa indipendenti mill- konċentrazzjoni b’ valuri ta ’ bejn 30 u 3000 pikogrammi/ ml u tammonta sa madwar 60%, li 9 minnhom 75% huma minħabba t- tgħaqqid ma ’ albumina.
9 • Metabolism
• Metaboliżmu
Iloprost is extensively metabolised principally via ß-oxidation of the carboxyl side chain.
Iloprost huma metabolizzat b’ mod estensiv prinċipalment permezz ta ’ l- ossidazzjoni ß tal- katina karboxil tal- ġenb.
No unchanged substance is eliminated.
L- ebda sustanza mhux mibdula m’ hi eliminata.
The main metabolite is tetranor-iloprost, which is found in the urine in free and conjugated form in 4 diastereoisomers.
Il- metabolu prinċipali huwa tetranor- iloprost, li jinstab fl- awrina fil- forma libera u fil- forma kkonjugata f’ 4 dijasterjoajsomers.
Tetranor-iloprost is pharmacologically inactive as shown in animal experiments.
Tetranor- ijloprost huwa farmakoloġikament inattiv kif intwera f’ esperimenti fuq l- annimali.
Results of in vitro studies reveal that CYP 450-dependent metabolism plays only a minor role in the biotransformation of iloprost.
Riżultati ta ’ studji in vitro wrew li l- metaboliżmu, li jiddependi minn CYP 450, għandu biss funzjoni minuri fil- bijotrasformazzjoni ta ’ iloprost.
Further in vitro studies suggest that metabolism of iloprost in the lungs is similar after intravenous administration or inhalation.
Studji oħra in vitro jissuġġerixxu li l - metaboliżmu ta ’ iloprost fil- pulmuni huwa simili wara l- għotja ġol- vina jew permess ta ’ ġbid tan - nifs għal ġol- pulmuni.
• Elimination
• Tneħħija
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.
F’ suġġetti b’ funzjoni normali tal- kliewi u tal- fwied, id- dispożizzjoni ta ’ iloprost wara infużjoni ġol- vina hija kkaratterizzata fil- biċċa l- kbira tal- każi minn profil b’ żewġ fażijiet, b’ ħinijiet medji biex il- konċentrazzjoni tonqos bin- nofs ta ’ 3 sa 5 minuti u 15 sa 30 minuti.
A mass-balance study was done using 3H-iloprost in healthy subjects.
3 Sar studju tal- bilanċ tal- massa bl- użu ta ’ H- iloprost f’ suġġetti f’ saħħithom.
Following intravenous infusion, the recovery of total radioactivity is 81%, and the respective recoveries in urine and faeces are 68% and 12%.
Wara infużjoni ġol- vina, l- irkupru tar- radjuattività totali hu ta ’ 81%, u l- irkupri rispettivi fl- awrina u fil- ħmieġ huma ta ’ 68% u 12%.
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.
Il- metaboliti huma eliminati mill- plażma u mill- awrina f’ 2 fażijiet, li għalihom kienu kkalkulati ħinijiet biex jonqsu bin- nofs ta ’ madwar 2 u 5 siegħat (plażma) u 2 u 18 siegħat (awrina).
• Pharmacokinetics after use with different nebulisers
• Farmakokinetika wara l- użu b’ nebulizzaturi differenti
In a randomized, crossover study with 20 healthy adult men, pharmacokinetics was investigated following inhalation of Ventavis (5 mcg iloprost) by the I-Neb AAD in comparison to the ProDose (5 mcg disk).
Fi studju randomized u crossover b’ 20 raġel adult b’ saħħtu, il- farmakokinetika kienet investigata wara t- teħid man- nifs ta ’ Ventavis (5 mcg iloprost) bl- I- Neb AAD f’ paragun mal - ProDose (diska ta ’ 5 mcg).
Higher maximum serum level (Cmax) and systemic exposure (AUC(0-tlast)) as well as a shorter time to reach maximum serum concentration (tmax) were found following Ventavis inhalation via the I-Neb AAD in comparison to the ProDose nebulizer.
Livell massimu fis- serum (Cmax) u esponiment sistemiku (AUC( 0- tlast)) ogħla kif ukoll ħin iqsar biex tintlaħaq il- konċentrazzjoni massima fis- serum (tmax) instabu wara t- teħid man- nifs ta ’ Ventavis permezz tal- I- Neb AAD f’ paragun man- nebulizzatur ProDose.
The pharmacokinetic results reflect the slightly different in vitro characteristics of these nebulizers (see Section 4.2).
Ir- riżultati farmakokinetiċi jirriflettu d - differenza ħafifa fil- karatteristiċi in vitro ta ’ dawn in- nebulizzaturi (ara sezzjoni 4. 2).
ProDose
Parametri farmakoinetiċi ta ’ iloprost wara teħid man- nifs ta ’ 5 mcg iloprost minn I- Neb AAD vs.
geometric mean (CV%)
ProDose AUC( 0- tlast) Tmax Cmax (pg· h/ mL) (h), (pg/ mL) medja geometrika (CV%) medjan (firxa) medja geometrika (CV%)
median (range)
I- Neb ProDose
119 (41.2%)
119 (41. 2%) 80. 0 (46. 7%)
ProDose
0. 147
0.183 (0.133 – 0.279)
(0. 086 – 0. 268) 0. 183 (0. 133 – 0. 279)
18.7 (50.5%)
28. 9 (47. 4%) 18. 7 (50. 5%)
Area under the concentration time curve from 0h data point up to last measurable
AUC( 0- tlast) = Erja taħt il- kurva tal- konċentrazzjoni vs ħin mill- punt ta ’ tagħrif 0h sa l- aħħar livell fis- serum li jista ’ jitkejjel CV = koeffiċjent ta ’ varjazzjoni
CV = coefficient of variation
• Karatteristiċi fil- pazjenti
10 • Characteristics in patients
Problemi fil- funzjoni tal- kliewi:
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).
Fi studju b’ infużjoni ġol- vina ta ’ iloprost, pazjenti b’ kollass tal- funzjoni tal- kliewi fl- istadju ta ’ l- aħħar li kien qed jieħdu kura intermittenti ta ’ dijalisi, intwera li għandhom tneħħija sinnifikattivament aktar 10 baxxa (medja ta ’ CL = 5 ± 2 ml/ min/ kg) minn dak osservat f’ pazjenti b’ kollass tal- funzjoni tal- kliewi li ma kienx qed ikollhom kura intermittenti ta ’ dijalisi (medja ta ’ CL = 18 ± 2 ml/ min/ kg).
Hepatic dysfunction:
Problemi fil- funzjoni tal- fwied:
Because iloprost is extensively metabolised by the liver, the plasma levels of the active substance are influenced by changes in hepatic function.
Minħabba li iloprost huwa metabolizzat mod estensiv mill- fwied, il- livelli fil- plażma tas- sustanza attiva huma influwenzati minn tibdil fil- funzjoni tal- fwied.
In an intravenous study, results were obtained involving 8 patients suffering from liver cirrhosis.
Riżultati kienu miksuba minn studju ta ’ għotja ġol- vina, b ’ 8 pazjenti li kienu jsofru minn ċirrożi tal- fwied.
The mean clearance of iloprost is estimated to be 10 ml/ minute/ kg.
Il- medja tat- tneħħija ta ’ iloprost hija stmata li tkun 10 ml/ minuta/ kg.
Age and gender:
Età u sess:
Age and gender are not of clinical relevance to the pharmacokinetics of iloprost.
L- età u s- sess mhumiex ta ’ rilevanza klinika għall- farmakokinetiċi ta ’ iloprost.
• Systemic toxicity
• Tossiċità sistemika
In acute toxicity studies, single intravenous and oral doses of iloprost caused severe symptoms of intoxication or death (IV) at doses about two orders of magnitude above the intravenous therapeutic dose.
Fi studji dwar it- tossiċità akuta, dożi waħidhom ta ’ iloprost ġol- vina u mill- ħalq ikkawżaw sintomi serji ta ’ avvelenament jew mewt ((IV) f’ dożi ta ’ madwar darbtejn għola mid- doża terapewtika ġol - vina.
Considering the high pharmacological potency of iloprost and the absolute doses required for therapeutic purposes the results obtained in acute toxicity studies do not indicate a risk of acute adverse effects in humans.
Meta wieħed jikkunsidra il- qawwa farmakoloġika għojla ta ’ ijloprost u d- dożi assoluti meħtieġa għal skopijiet terapewtiċi, ir- riżultati miksuba fi studji dwar it- tossiċità akuta ma jindikawx riskju ta ’ effetti avversi akuti fil- bnedmin.
As expected for a prostacyclin, iloprost produced haemodynamic effects (vasodilatation, reddening of skin, hypotension, inhibition of platelet function, respiratory distress) and general signs of intoxication such as apathy, gait disturbances, and postural changes.
Kif mistenni għal prostacycline, iloprost ipproduċa effetti emodinamiċi (vasodilatazzjoni, ħmura tal- ġilda, pressjoni baxxa, inibizzjoni tal - funzjoni tal- plejtlets, diffikulta ’ biex tieħu n- nifs) u sinjali ġenerali ta ’ avvelenament bħal apatija, disturbi fil- mod kif wieħed jimxi, u tibdil fil- pożizzjoni tal- ġisem.
Continuous IV/ SC 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).
Infużjoni kontinwa IV/ SC ta ’ iloprost sa 26 ġimgħa f’ annimali gerriema u dawn 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).
Only expected pharmacological effects like hypotension, reddening of skin, dyspnoea, increased intestinal motility were observed.
Effetti farmakoloġiċi mistennija biss bħal pressjoni baxxa, ħmura tal- ġilda, diffikulta ’ biex tieħu n- nifs, żjieda fil- moviment spontanju ta ’ l - imsaren kienu osservati.
Based on Cmax values in rats the systemic exposure in these parenteral studies was approximately 3.5 times higher than the maximum achievable exposure after inhalation.
Ibbażżati fuq valuri ta ’ Cmax fil- firien, l- espożizzjoni sistemika f’ dawn l- istudji b’ għotja mhux mill - ħalq kienu madwar 3. 5 darbiet ogħla mill- espożizzjoni massima li setgħet tintlaħaq wara l- għotja bi ġbid tan- nifs għal ġol- pulmuni.
This highest achievable dose of 48.7 micrograms/ kg/ day was also the “ no observed adverse effect level” (NOAEL) as evaluated in inhalation toxicity studies in rats up to 26 weeks.
L- ogħla doża li setgħet tintlaħaq ta ’ 48. 7 mikrogrammi/ kg/ kuljum kienet ukoll “ il- livell fejn ma kien osservat l- ebda effett mhux mixtieq ” (NOAEL) kif evalwat fi studji dwar it- tossiċità fil- ġbid tan- nifs għal ġol- pulmuni fil- firien sa 26 ġimgħa.
Following inhalation the systemic exposure based on AUC values in rats exceeded the corresponding therapeutic exposure in human patients by approximately 13 times.
Wara l- ġbid tan- nifs għal ġol- pulmuni, l- espożizzjoni sistemika bbażata fuq il- valuri ta ’ l- AUC fil- firien qabżet b’ madwar 13- il darba l- espożizzjoni korrispondenti terapewtika f’ pazjenti umani.
• Genotoxic potential, tumorigenicity
• Potenzjal ġenotossiku, tumoroġenetiċità
Iloprost is not a gene mutagen in bacterial and mammalian cells in vitro and is not clastogenic in human lymphocytes up to cytotoxic concentrations and in the micronucleus test in vivo.
Iloprost ma jbiddilx il- ġeni ta ’ ċelluli ta ’ batterji u ta ’ mammiferi in vitro u mhuwiex klastoġeniku la f’ limfoċiti umani sa konċentrazzjonijiet ċitossiċi u lanqas fit- test tal - mikronukleju in vivo.
No tumorigenic potential of iloprost could be demonstrated in tumorigenicity studies in rats and mice.
L- ebda potenzjal tumoroġeniku ta ’ iloprost ma seta jintwera fi studji dwar it- tumoroġenetiċità fil- firien u fil- ġrieden.
• Reproduction toxicology
• Tossikoloġija fir- riproduzzjoni
In embryo- and foetotoxicity studies in rats continuous intravenous administration of iloprost led to anomalies of single phalanges of the forepaws in a few foetuses/ pups without dose dependence.
Dan l - effett ma kienx dipendenti fuq id- doża.
11 These alterations are not considered as true teratogenic effects, but are most likely related to iloprost induced growth retardation in late organogenesis due to haemodynamic alterations in the foetoplacental unit.
Dawn il- bidliet mhumiex ikkunsidrati bħala effetti teratoġeniċi veri, imma huma x’ aktarx konnessi 11 ma ’ ttardjar fl- iżvilupp ikkaġunat minn iloprost lejn l- aħħar ta ’ l- organoġenesi minħabba tibdil emodinamiku fil- kumpless fetoplaċentali.
In comparable embryotoxicity studies in rabbits and monkeys no such digit anomalies or other gross-structural abnormalities were observed in the foetuses/ pups up to the highest tested dose.
Fi studji komparabbli dwar l- embrijotossiċità fil- fniek u fix- xadini l- ebda anomaliji bħal dawk fis- saqajn jew anormalitajiet strutturali kbar ma kienu osservati fil- feti/ frieħ sa l- ogħla doża ittestjata.
In rats, passage of extremely low levels of iloprost into the milk was observed.
Fil- firien, kienet osservata mogħdija ta ’ livelli baxxi ħafna ta ’ iloprost għal ġol- ħalib.
• Local tolerance, contact sensitising and antigenicity potential
• Tolleranza lokali, sensibilizzazzjoni tal- ġilda għall- kuntatt u potenzjal ta ’ antiġenetiċità
In inhalation studies in rats, the administration of an iloprost formulation with a concentration of 20 micrograms/ ml up to 26 weeks did not cause any local irritation of the upper and lower respiratory tract.
Fi studju fil- firien dwar il- ġbid tan- nifs għal ġol- pulmuni, l- għotja ta ’ formulazzjoni ta ’ iloprost b’ konċentrazzjoni ta ’ 20 mikrogrammi/ ml sa 26 ġimgħa, ma kkawżat l- ebda irritazzjoni lokali fis - sistema respiratorja ta ’ fuq u t’ isfel.
A dermal sensitisation (maximisation test) and an antigenicity study in guinea pigs showed no sensitising potential.
Fi studju dwar is- sensibilizzazzjoni tal- ġilda (test ta ’ massimizzazzjoni) u studju dwar l - antiġenetiċità fil- fniek ta ’ l- Indi ma wrew l- ebda potenzjal ta ’ sensibilizzazzjoni.
Trometamol, Ethanol 96%, Sodium chloride, Hydrochloric acid (for pH adjustment), Water for injections
Trometamol Ethanol 96%, Sodium chloride, Hydrochloric acid (għall- aġġustament tal- pH), Ilma għall- injezzjonijiet
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Fl- assenza ta ’ studji dwar il- kompatilibilità, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħra.
This medicinal product does not require any special storage conditions.
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
1-ml ampoules, colourless, glass type I, containing 1 ml nebuliser solution, ring coded with three coloured rings (pink – red- red).
Ampulli ta ’ 1- ml, bla kulur, ħġieġ tat- tip I, li fihom 1 ml ta ’ soluzzjoni għan- nebulizzatur, mmarkati bi tlett ċrieki kkuluriti (roża – aħmar – aħmar).
3-ml ampoules, colourless, glass type I, containing 2 ml nebuliser solution, ring coded with two coloured rings (white – pink).
Ampulli ta ’ 3- ml, bla kulur, ħġieġ tat- tip I, li fihom 2 ml ta ’ soluzzjoni għan- nebulizzatur, mmarkati b’ żewġ ċrieki kkuluriti (abjad- roża).
1 ml nebuliser solution:
1 ml soluzzjoni għan- nebulizzatur:
Packages containing 30 or 168 ampoules.
Pakketti fihom 30 jew 168 ampulla.
2 ml nebuliser solution:
2 ml soluzzjoni għan- nebulizzatur:
Packages containing 30, 90, 100 or 300 ampoules.
Pakketti fihom 30, 90, 100 u 300 ampulla.
12 6.6 Special precautions for disposal and other handling
12 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
For each inhalation session the contents of one opened ampoule of Ventavis has to be transferred into the nebuliser medication chamber immediately before use.
Għal kull sessjoni ta ’ ġbid tan- nifs għal ġol- pulmuni, il- kontenut ta ’ ampulla waħda miftuħa ta ’ Ventavis jrid ikun trasferit fil- kompartiment tal- medikazzjoni tan- nebulizzatur dritt qabel l- użu.
After each inhalation session, any solution remaining in the nebuliser should be discarded.
Wara kull sessjoni ta ’ ġbid tan- nifs għal ġol- pulmuni, xi soluzzjoni li jkun fadal fin- nebulizzatur għandha tintrema.
16 September 2003 Date of last renewal:
16 ta ’ Settembru, 2003 Data ta ’ l- aħħar tiġdid:
16 September 2008
16 ta ’ Settembru, 2008
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTURI TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL - LOTT
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTURI TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
Name and address of the manufacturers responsible for batch release
Isem u indirizz tal- manifattur responsabbli mill- ħruġ tal- lott.
S. A., Poligono Industrial Santa Rosa s/ n, 28806 Alcalá de Henares, Madrid, Spain
S. A., Poligono Industrial Santa Rosa s/ n, 28806 Alcalá de Henares, Madrid, Spanja.
Summary of Product Characteristics, section 4.2)
Karatteristiċi tal- Prodott fil - Qosor, 4. 2)
The Marketing Authorisation Holder will submit yearly PSURs unless otherwise specified by the CHMP.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq ser jissottometti PSURs kull sena sakemm mhux speċifikat mod ieħor mis- CHMP.
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/ risk profile.
Id- detentur ta ’ L- awtorizzazzjoni għat- tqegħid fis- suq għandu jtemm il- programm ta 'studji li ġejjin fiż- żmien speċifikat, u r- riżultati ta' dawn l- istudji għandhom iservu ta 'bażi għall- istima tal- profil bejn il- benefiċċju/ riskju li ssir kull sena.
In July 2004, the CHMP and MAH agreed on a protocol for an observational study 308120 to gather longer-term data on the safety and efficacy of Ventavis (iloprost).
F’ Lulju 2004, is- CHMP u l- MAH qablu fuq protokoll biex isir studju ta ’ l- osservazzjoni numru 308120 sabiex jinġabar tagħrif fuq perijodu twil ta ’ żmien dwar is- sigurtà u l- effikaċja ta ’ Ventavis (iloprost).
The first patient will be enrolled by April 2005 the latest.
L- ewwel pazjent ser jiġi rreġistrat sa mhux iktar tard minn April 2005.
Progress reports will be provided together with the submission of the PSURs.
Rapporti dwar il - progress ser jiġu pprovduti flimkien mas- sottomissjoni tal- PSURs.
A final study report will be provided within 6 months after last patient completed and forwarded for review by CHMP, estimated dated of 4Q 2011.
Rapport dwar l- istudju finali ser jiġi pprovdut sa 6 xhur wara li l- istudju fuq l- aħħar pazjent ikun intemm u ntbagħat għall - konsiderazzjoni tas- CHMP.
(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)
PAKKETT B’ 30 AMPULLA FI KARTUNA B’ 90 (3 X 30) AMPULLA TA ’ 2 ML) PAKKETT B’ 30 AMPULLA FI KARTUNA B’ 300 (10 X 30) AMPULLA TA ’ 2 ML)
Ventavis 10 microgram/ ml, Nebuliser solution Iloprost
Ventavis 10 mikrogrammi/ ml, Soluzzjoni għan- nebulizzatur Iloprost
Each ampoule with 2 ml contains 20 micrograms iloprost (as iloprost trometamol).
Kull ampulla ta ’ 2 ml fiha 20 mikrogrammi ta ’ iloprost (bħala iloprost trometamol).
Excipients: trometamol, ethanol 96%, sodium chloride, hydrochloric acid (for pH adjustment), water for injections.
Sustanzi mhux attivi: trometamol, ethanol 96%, sodium chloride, hydrochloric acid (għall- aġġustament tal- pH), ilma għall- injezzjonijiet
30 ampoules with 2 ml.
Soluzzjoni għan- nebulizzatur 30 ampulla b’ 2 ml Parti minn kaxxa li fiha 90 ampulla ta ’ 2 ml.
Part of a box containing 90 ampoules with 2 ml.
M’ hemmx bejgħ ta ’ pakketti individwali.
Part of a box containing 300 ampoules with 2 ml.
Parti minn kaxxa li fiha 300 ampulla ta ’ 2 ml.
No individual sale of single packs.
M’ hemmx bejgħ ta ’ pakketti individwali.
Inhalation use.
5.
Read the package leaflet before use.
MOD TA ’ KIF U MNEJN JINGĦATA
(OUTER CARTON / 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)
19 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TA ’ BARRA / 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)
Ventavis 10 microgram/ ml nebuliser solution Iloprost
Ventavis 10 mikrogrammi/ ml, soluzzjoni għan- nebulizzatur Iloprost
1 ml solution contains 10 micrograms iloprost (as iloprost trometamol).
Kull 1 ml ta ’ soluzzjoni fiha 10 mikrogrammi ta ’ iloprost (bħala iloprost trometamol).
Each ampoule with 2 ml contains 20 micrograms iloprost.
Kull ampulla ta ’ 2 ml fiha 20 mikrogrammi ta ’ iloprost
Excipients: trometamol, ethanol 96%, sodium chloride, hydrochloric acid (for pH adjustment), water for injections
Sustanzi mhux attivi: trometamol, ethanol 96%, sodium chloride, hydrochloric acid (għall- aġġustament tal- pH), ilma għall- injezzjonijiet
30 ampoules with 2 ml.
30 ampulla b’ 2 ml.
90 ampoules with 2 ml.
90 ampulla b’ 2 ml.
90 (3 x 30) ampoules with 2 ml.
90 (3 x 30) ampulla b’ 2 ml.
100 ampoules with 2 ml.
100 ampulla b’ 2 ml.
300 ampoules with 2 ml.
300 ampulla b’ 2 ml.
300 (10 x 30) ampoules with 2 ml.
300 (10 x 30) ampulla b’ 2 ml.
(PACK WITH 42 AMPOULES IN A CARTON WITH 168 (4 x 42) AMPOULES WITH 1 ML)
PAKKETT B’ 42 AMPULLA FI KARTUNA B’ 168 (4 X 42) AMPULLA TA ’ 1 ML)
Each ampoule with 1 ml contains 10 micrograms iloprost (as iloprost trometamol).
Kull ampulla ta ’ 1 ml fiha 10 mikrogrammi ta ’ iloprost (bħala iloprost trometamol).
42 ampoules with 1 ml.
Soluzzjoni għan- nebulizzatur 42 ampulla b’ 1 ml Parti minn kaxxa li fiha 168 ampulla ta ’ 1 ml.
Part of a box containing 168 ampoules with 1 ml.
M’ hemmx bejgħ ta ’ pakketti individwali.
No individual sale of single packs.
5.
Read the package leaflet before use.
Għall- użu permess ta ’ ġbid tan- nifs għal ġol- pulmuni Aqra l- fuljett fil- pakkett qabel l- użu
(OUTER CARTON / 30 AMPOULES WITH 1 ML 168 AMPOULES WITH 1 ML)
(KARTUNA TA ’ BARRA / 30 AMPULLA B’ 1 ML 168 AMPULLA B’ 1 ML
30 ampoules with 1 ml.
30 ampulla b’ 1 ml.
168 ampoules with 1 ml.
168 ampulla b’ 1 ml.
(AMPOULE WITH 2 ML)
(AMPULLA B’ 2 ML)
Ventavis 10 microgram/ ml nebuliser solution Iloprost Inhalation use
Ventavis 10 mikrogrammi/ ml, soluzzjoni għan- nebulizzatur Iloprost Għall- użu permess ta ’ ġbid tan- nifs għal ġol- pulmuni
(AMPOULE WITH 1 ML)
(AMPULLA B’ 1 ML)
Ventavis 10 microgram/ ml nebuliser solution Iloprost Inhalation use
Ventavis 10 mikrogrammi/ ml, soluzzjoni għan- nebulizzatur Iloprost Għal biex jinġibed man- nifs
28 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF
Ventavis 10 microgram/ ml nebuliser solution Iloprost
Ventavis 10 mikrogrammi/ ml soluzzjoni tan- nebulizzatur Iloprost
What Ventavis is and what it is used for 2.
X’ inhu Ventavis u għalxiex jintuża 2.
Before you use Ventavis 3.
Qabel ma tużaVentavis 3.
How to use Ventavis 4.
Kif għandek tużaVentavis 4.
Possible side effects 5 How to store Ventavis 6.
Effetti sekondarji li jista ’ jkollu 5.
Further information
Kif taħżen Ventavis 6.
WHAT VENTAVIS IS AND WHAT IT IS USED FOR
X’ INHU VENTAVIS U GĦALXIEX JINTUŻA
What Ventavis is:
X' inhu Ventavis:
Ventavis is a nebuliser solution.
Ventavis huwa soluzzjoni għan- nebulizzatur.
The solution is changed into an aerosol mist by a special machine called a nebuliser.
Din is- soluzzjoni tinbidel fi ċpar ta ’ l- aerosol b’ magna speċjali msejħa nebulizzatur.
Breathing in the mist carries Ventavis to the lungs, where it can work most effectively in the artery between heart and lungs.
X’ ħin tiġbed dan iċ- ċpar man- nifs, dan iwassal Ventavis fil- pulmun, fejn ikun jista ’ jaħdem bl- aktar mod effettiv fl- arterja ta ’ bejn il- qalb u l- pulmun.
How Ventavis works:
Kif jaħdem Ventavis:
Ventavis imitates a natural substance in the body called prostacyclin.
Ventavis jimita sustanza naturali fil- ġisem li tissejjaħ prostacycline.
Ventavis and prostacyclin inhibit unwanted blocking or narrowing of blood vessels and allow more blood to flow through the arteries.
Ventavis u prostacyclin jinibixxu bblukkar mhux mixtieq jew tidjiq ta ’ vini u arterji tad- demm u jħallu iktar demm jgħaddi minn ġo l- arterji.
What Ventavis is used for:
Għalxiex jintuża Ventavis:
Ventavis is used to treat moderate cases of primary pulmonary hypertension (PPH).
Ventavis jintuża biex jikkura każijiet moderati ta ’ pressjoni pulmonari għolja primarja (PPH).
This is a condition where blood pressure is too high in the blood vessels between the heart and the lungs.
Din hija kondizzjoni fejn il- pressjoni tad- demm hija għolja wisq fil- vini u fl- arterji ta ’ bejn il- qalb u l- pulmun.
Ventavis tends to lower blood pressure within the pulmonary artery, by improving blood flow.
Ventavis għandu tendenza li jbaxxi l- pressjoni tad- demm fl- arterja pulmonari, billi jtejjeb iċ - ċirkolazzjoni tad- demm.
This means less work for the heart.
Dan ifisser inqas xogħol għall- qalb.
Improved blood flow leads to an improved supply of oxygen to the body and reduced strain on the heart.
Titjib fiċ- ċirkolazzjoni tad- demm iwassal għal titjib fil- provvista ta ’ ossiġnu lill- ġisem u inqas sforz fuq il- qalb.
The heart can function more effectively.
Il- qalb tkun tista ’ tiffunzjona b’ mod aktar effettiv.
BEFORE YOU USE VENTAVIS
QABEL MA TUŻA VENTAVIS
• If you are allergic (hypersensitive) to iloprost or any of the other ingredients of Ventavis. • If you are at risk of bleeding – for example, active stomach ulcers, injuries, or other bleeding • If you have a significant suspected build-up of fluid in the lungs, with difficulty in breathing • If your disease is due to a blocked or narrow vein rather than a blocked or narrow artery. • If you have had a stroke within the last 3 months, or any other interruption of blood supply to the brain • If you have a heart problem, for example:
Tużax Ventavis Jekk taħseb li xi wieħed/ waħda minn dawn jgħoddu għalik, jekk jogħġbok għid lit- tabib tiegħek: • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal iloprost jew sustanzi oħra ta ’ Ventavis. • Jekk inti għandek riskju ta ’ fsad ta ’ demm – per eżempju, ulċeri attivi ta ’ l- istonku, feriti, jew fsad ieħor tad- demm 30 • Jekk għandek akkumulazzjoni sinifikanti ta ’ ilma fil- pulmun, flimkien ma ’ diffikultà biex tieħu n- nifs • Jekk il- mard tiegħek huwa minħabba xi vina ibblukkata jew dejqa mhux minħabba arterja ibblukkata jew dejqa • Jekk kellek puplesija matul l- aħħar 3 xhur, jew xi interruzzjoni oħra fil- provvista ta ’ demm lejn il- moħħ • Jekk għandek xi problema tal- qalb, per eżempju:
- you sometimes have chest pain
‫־ ‬ ‫־ ‬ ‫־ ‬ ‫־ ‬ ‫־ ‬
- poor blood flow to the muscles of the heart (coronary heart disease)
attakk tal- qalb matul l- aħħar sitt xhur tibdil serju fir- rata ta ’ taħbit tal- qalb jekk xi kultant ikollok uġigħ f’ sidrek ċirkolazzjoni tad- demm batuta lejn il- muskoli tal- qalb (mard koronarju tal- qalb) xi mard tal- qalb li mhux qed ikun ikkurat jew mhux taħt osservazzjoni medika mill- qrib dijanjosi ta ’ difett tal- qalb
-
‫־ ‬
any disease of the heart which is not being treated or not under close medical observation
bħal valv tal- qalb difettuż li jġiegħel il- qalb biex taħdem b’ mod batut.
a heart defect has been diagnosed, such as a faulty heart valve that causes the heart to work poorly.
• Jekk inti tqila jew qed tredda ’ (ara sezzjoni 2.
• If you are pregnant or breast-feeding (see section 2., Take special care, ‘ Pregnancy, ‘ Breast-feeding’).
Oqgħod attent ħafna, ‘ Tqala ’, ‘ Treddigħ ’).
Inhaling Ventavis
Oqgħod attent ħafna b’ Ventavis − Jekk għandek infezzjoni tal- pulmuni, ażżma severa, jew xi mard ieħor tal - pulmuni.