natgillin/translations-raw huggingface dataset:
The Committee for Medicinal Products for Human Use (CHMP) decided that, despite the limited data available, Ventavis’ s benefits are greater than its risks for the treatment of patients with primary pulmonary hypertension, classified as NYHA functional class III, to improve exercise capacity and symptoms.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so kljub omejenim razpoložljivim podatkom, koristi zdravila Ventavis pri zdravljenju bolnikov s primarno pljučno hipertenzijo, razvrščeno v funkcijski razred III NYHA, za izboljšanje fizične zmogljivosti in simptomov, večje od z njim povezanih tveganj.
The Committee recommended that Ventavis be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Ventavis odobri dovoljenje za promet.
Ventavis has been authorised under ‘ Exceptional Circumstances’, because, as the disease is rare, it has not been possible to obtain complete information on the medicine.
Zdravilo Ventavis je bilo odobreno v „ izjemnih okoliščinah “, ker zaradi redkosti bolezni ni bilo mogoče pridobiti vseh informacij o zdravilu.
Every year, the European Medicines Agency (EMEA) will review any new information that may become available and this summary will be updated as necessary.
Evropska agencija za zdravila (EMEA) bo vsako leto pregledala vse nove razpoložljive informacije in po potrebi posodobila ta povzetek.
Which information is still awaited for Ventavis?
Katere informacije o zdravilu Ventavis še pričakujemo?
The company that makes Ventavis will carry out further studies to collect data on the long-term use of the medicine.
Družba, ki izdeluje zdravilo Ventavis, bo izvedla nadaljnje študije, da bi zbrala podatke o dolgotrajni uporabi tega zdravila.
Other information about Ventavis:
Druge informacije o zdravilu Ventavis:
The European Commission granted a marketing authorisation valid throughout the European Union for Ventavis to Bayer Schering Pharma AG on 16 September 2003.
Evropska komisija je dovoljenje za promet z zdravilom Ventavis, veljavno po vsej Evropski uniji, odobrila družbi Bayer Schering Pharma AG dne 16. septembra 2003.
The marketing authorisation was renewed on 16 September 2008.
Dovoljenje za promet je bilo obnovljeno 16. septembra 2008.
The record of Ventavis’ s designation as an orphan medicine is available here.
Zapis o določitvi zdravila Ventavis kot zdravila sirote je na voljo tukaj.
The full EPAR for Ventavis can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ventavis je na voljo tukaj.
Pharmaceutical Form
Inhalacijska uporaba
Route of Administration
Inhalacijska uporaba
Packaging
10 µg/ ml
Content
30 ampul
Package size
1 ml (10 µg/ ml)
Ventavis Ventavis Ventavis Ventavis Ventavis Ventavis Ventavis Ventavis
Inhalacijska uporaba
Inhalation use Inhalation use Inhalation use Inhalation use Inhalation use Inhalation use Inhalation use Inhalation use
Inhalacijska raztopina za nebulator
ampoule (glass) ampoule (glass) ampoule (glass) ampoule (glass) ampoule (glass) ampoule (glass) ampoule (glass) ampoule (glass)
Inhalacijska raztopina za nebulator
30 ampoules 100 ampoules 300 ampoules 30 ampoules 168 ampoules 90 ampoules 3 x 30 ampoules 10 x 30 ampoules
10 x 30 ampul
Ventavis 10 microgram/ ml nebuliser solution
Ventavis 10 mikrogramov/ ml inhalacijska raztopina za nebulator
1 ml solution contains 10 micrograms iloprost (as iloprost trometamol).
1 ml raztopine vsebuje 10 mikrogramov iloprosta (v obliki trometamolijevega iloprostata).
Each ampoule with 1 ml contains 10 micrograms iloprost.
Vsaka ampula z 1 ml raztopine vsebuje 10 mikrogramov iloprosta.
Each ampoule with 2 ml contains 20 micrograms iloprost.
Vsaka ampula z 2 ml raztopine vsebuje 20 mikrogramov iloprosta.
For a full list of excipients, see section 6.1.
Pomožne snovi: etanol 96% 0, 81 mg na ml Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
Clear, colourless solution.
Inhalacijska raztopina za nebulator Prozorna, brezbarvna raztopina
Treatment of patients with primary pulmonary hypertension, classified as NYHA functional class III, to improve exercise capacity and symptoms.
Zdravljenje bolnikov s primarno pljučno hipertenzijo opredeljeno kot funkcijski razred III po NYHA za izboljšanje fizične zmogljivosti in simptomov.
Ventavis is intended for inhalation use by nebulisation (see section 6.6).
Zdravilo Ventavis je namenjeno za inhalacijsko uporabo s pomočjo nebulatorja (glejte poglavje 6. 6).
• Dose per inhalation session:
• Odmerek na posamezno inhalacijo:
The recommended dose is 2.5 micrograms or 5.0 micrograms of inhaled iloprost (as delivered at the mouthpiece of the nebuliser), starting with the low dose of 2.5 microgram for the first inhalation, followed by 5.0 micrograms for the second inhalation.
Priporočeni odmerek je 2, 5 mikrogramov ali 5 mikrogramov inhaliranega iloprosta (apliciranega skozi ustnik nebulatorja), z začetnim nižjim 2, 5 mikrogramskim odmerkom za prvo inhalacijo, ki ji sledi 5 mikrogramski odmerek za drugo inhalacijo.
In case of poor tolerability of the 5.0 microgram dose, the dose should be reduced to 2.5 micrograms.
V primeru slabega prenašanja 5 mikrogramskega odmerka je treba odmerek znižati na 2, 5 mikrograme.
Two compressed air nebuliser systems, HaloLite and Prodose, have been shown to be suitable nebulisers for the administration of Ventavis.
HaloLite in Prodose.
With both systems the mass median aerodynamic diameter of the aerosol droplet (MMAD) with iloprost was between 2.6 and 2.7 micrometres.
Pri obeh je povprečni masni aerodinamični premer kapljice aerosola (MMAD - 'mass median aerodynamic diameter') z iloprostom med 2, 6 in 2, 7 mikrometra.
For each inhalation session the content of one ampoule containing 2 ml of Ventavis nebuliser solution will be transferred into the nebuliser medication chamber immediately before use.
Za vsako inhalacijo se vsebina ene ampule, ki vsebuje 2 ml Ventavis inhalacijske raztopine za nebulator, neposredno pred uporabo prenese v prostor za zdravilo v nebulatorju.
HaloLite and Prodose are dosimetric systems.
HaloLite in Prodose sta sistema za odmerjanje.
They stop automatically after the pre-set dose has been delivered.
Po aplikaciji vnaprej določenega odmerka se samodejno ustavita.
The inhalation time depends on the patient ’ s breathing pattern.
Trajanje inhalacije je odvisno od bolnikovega načina dihanja.
Dose of iloprost at
Odmerek iloprosta pri
mouthpiece
ustniku
(frequency of 15 breaths per minute)
(frekvenca dihanja 15/ min)
4 to 5 min
4 do 5 min
8 to 10 min
8 do 10 min
For a dose of 5 micrograms iloprost at mouthpiece it is recommended to complete two inhalation cycles with 2.5 micrograms pre-set dose program with a filling of one ampoule containing 2 ml Ventavis nebuliser solution, which shows two coloured rings (white – pink).
Za odmerek 5 mikrogramov iloprosta pri ustniku je priporočljivo narediti dva inhalacijska cikla s predhodno določenim odmerkom 2, 5 mikrogramov in polnjenjem iz ene ampule, ki vsebuje 2 ml Ventavis inhalacijske raztopine za nebulator, na kateri sta dva barvna obroča (bel in rožnat).
Venta-Neb, a portable ultrasonic battery-powered nebuliser, has also been shown to be suitable for the administration of Ventavis.
Prenosni, ultrazvočni, baterijski nebulator Venta- Neb je dokazano primeren tudi za apliciranje zdravila Ventavis.
The measured MMAD of the aerosol droplets was 2.6 micrometres.
Izmerjeni masni aerodinamični premer kapljice aerosola (MMAD) je 2, 6 mikrometra.
For each inhalation session, the content of one ampoule containing 2 ml Ventavis nebuliser solution and showing two coloured rings (white – pink) will be transferred into the nebuliser medication chamber immediately before use.
Za vsako inhalacijo se vsebina ene ampule, ki vsebuje 2 ml Ventavis inhalacijske raztopine za nebulator, na kateri sta dva barvna obroča (bel in rožnat), neposredno pred inhalacijo prenese v prostor za zdravilo v nebulatorju.
Two programs can be operated:
Na voljo sta dva programa:
5.0 micrograms active substance on the mouth piece 25 inhalation cycles.
5 mikrogramov zdravilne učinkovine na ustniku 25 inhalacijskih ciklov.
2.5 micrograms active substance on the mouth piece 10 inhalation cycles.
2, 5 mikrogramov zdravilne učinkovine na ustniku 10 inhalacijskih ciklov.
The selection of the pre set program is made by the physician.
Zdravnik predhodno izbere določen program.
Venta-Neb prompts the patient to inhale by an optical and an acoustic signal.
Nebulator Venta- Neb z optičnim in zvočnim signalom spodbudi bolnika, naj vdihne.
It stops after the pre-set dose has been administered.
Oddajanje signala se ustavi po aplikaciji vnaprej pripravljenega odmerka.
To obtain the optimal droplet size for the administration of Ventavis the green baffle plate should be used.
Da bi dosegli optimalno velikost kapljic za aplikacijo zdravila Ventavis je treba uporabiti zeleno ploščo.
For details refer to the instruction manual of the Venta-Neb nebuliser.
Za podrobnosti glejte navodila za uporabo nebulatorja Venta- Neb.
2.5 micrograms
Odmerek iloprosta pri ustniku 2, 5 mikrogramov
4 min
Predviden inhalacijski čas 4 min
The I-Neb AAD System is a portable, hand-held, vibrating mesh technology nebuliser system.
Nebulator I- Neb AAD je prenosni, ročni sistem za razprševanje, ki temelji na tehnologiji vibrirajoče mrežice.
This system generates droplets by ultrasound, which is forcing the solution through a mesh.
Sistem z ultrazvokom potiska raztopino skozi mrežico in tako ustvarja kapljice.
The I-Neb AAD nebuliser has also been shown to be suitable for the administration of Ventavis.
Nebulator I- Neb AAD je primeren tudi za apliciranje zdravila Ventavis.
The measured MMAD of the aerosol droplets was 2.1 micrometres.
Izmerjena vrednost MMAD aerosolnih kapljic je bila 2, 1 mikrometra.
This nebuliser monitors the breathing pattern to determine the aerosol pulse time required to deliver the pre-set dose of 2.5 or 5 micrograms iloprost.
Nebulator spremlja način dihanja in tako določi pulzni čas aerosola, potreben za dovajanje nastavljenega odmerka 2, 5 ali 5 mikrogramov iloprosta.
The pre-set dose provided by the I-Neb AAD system is controlled by the medication chamber in combination with a control disc.
Prostor za zdravilo v kombinaciji z nadzornim diskom nadzira nastavljeni odmerek, ki ga dovaja nebulator I- Neb AAD.
There are two different colour coded medication chambers.
Obstajata dva prostora za zdravilo z različnima barvnima oznakama.
For each medication chamber there is a corresponding colour coded control disc:
Za vsak prostor za zdravilo obstaja nadzorni disk, označen z ustrezno barvo:
For the 2.5 micrograms dose the medication chamber (350 microliter) with the red latch is used together with the red control disc.
Za odmerek 2, 5 mikrogramov se uporablja prostor za zdravilo (350 mikrolitrov) z rdečim zapahom in rdečim nadzornim diskom.
For the 5 micrograms dose the medication chamber (650 microliter) with the purple coloured latch is used together with the purple control disc.
Za odmerek 5 mikrogramov se uporablja prostor za zdravilo (650 mikrolitrov) z vijoličastim zapahom in vijoličastim nadzornim diskom.
For each inhalation session with the I-Neb AAD, the content of one 1-ml ampoule of Ventavis, showing three coloured rings (pink – red- red), will be transferred into the appropriate nebuliser medication chamber immediately before use.
Za vsak inhalacijski cikel z nebulatorjem I- Neb AAD se vsebina ene 1- mililitrske ampule zdravila Ventavis, na kateri so trije barvni obroči (rožnat– rdeč– rdeč), neposredno pred uporabo prenese v ustrezen prostor za zdravilo v nebulatorju.
Device
Pripomoček I- Neb AAD
Estimated
Odmerek
2.5 micrograms
iloprosta pri ustniku 2, 5 mikrogramov 5 mikrogramov
I-Neb AAD
Predviden
5 micrograms
inhalacijski čas 3, 2 min 6, 5 min
Since the I-Neb nebuliser has been shown to produce an aerosol with slightly different physical characteristics to those of HaloLite, Prodose and VentaNeb devices and a faster delivery of the solution (see section 5.2), patients stabilized on one nebuliser should not switch to another nebuliser without supervision by the treating physician.
Zato bolniki, katerih stanje je stabilno ob uporabi določenega nebulatorja, ne smejo preiti na uporabo drugega brez nadzora svojega zdravnika.
The efficacy and tolerability of inhaled iloprost when administered with other nebulising systems, which provide different nebulisation characteristics of iloprost solution, have not been established.
Učinkovitost in prenašanje inhaliranega iloprosta ob uporabi drugih nebulatorjev, ki dajejo raztopini iloprosta drugačne pršilne lastnosti, niso ugotavljali.
• Daily dose:
• Dnevni odmerek:
The dose per inhalation session should be administered 6 to 9 times per day according to the individual need and tolerability.
Inhalacijski odmerek je potrebno aplicirati šest - do devetkrat na dan, glede na potrebe posameznika in prenašanje zdravila.
• Duration of treatment:
• Trajanje zdravljenja:
The duration of treatment depends on clinical status and is left to the physician’ s discretion.
Trajanje zdravljenja je odvisno od kliničnega stanja in je prepuščeno presoji zdravnika.
Iloprost elimination is reduced in patients with hepatic dysfunction (see section 5.2).
Pri bolnikih z okvaro jeter je izločanje iloprosta zmanjšano (glejte poglavje 5. 2).
Initially, doses of 2.5 micrograms should be administered with dosing intervals of at least 3 hours (corresponds to administration of max.
V začetku mora med aplikacijo posameznih 2, 5 mikrogramskih odmerkov preteči vsaj 3 ure (kar ustreza največ 6 aplikacijam dnevno).
Thereafter, dosing intervals may be shortened cautiously based on individual tolerability.
Kasneje se lahko intervali odmerjanja previdno krajšajo glede na bolnikovo prenašanje zdravila.
If a further increase in the dose up to 5.0 micrograms is indicated, again dosing intervals of at least 3 hours should be chosen initially and shortened according to individual tolerability.
Če je indicirano nadaljnje zvečevanje odmerka do 5 mikrogramov, mora začetni interval odmerjanja ponovno znašati vsaj 3 ure, nato pa se krajša glede na bolnikovo prenašanje zdravila.
A further undesired accumulation of the medicinal product following treatment over several days is not likely due to the overnight break in administration of the medicinal product.
Zaradi prekinitve aplikacije zdravila ponoči nadaljnje neželeno kopičenje zdravila po več dni trajajočem zdravljenju ni verjetno.
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).
Pri bolnikih z očistkom kreatinina > 30 ml/ min (določenega po Cockroftovi in Gaultovi formuli iz vrednosti kreatinina v serumu) prilagajanje odmerka ni potrebno.
Patients with a creatinine clearance of ≤ 30 ml/ min were not investigated in the clinical trials.
Bolniki z očistkom kreatinina ≤ 30 ml/ min niso bili vključeni v klinična preskušanja.
There is no experience with Ventavis in children or adolescents.
Izkušenj o uporabi zdravila Ventavis pri otrocih in mladostnikih ni.
− Hypersensitivity to the active substance or to any of the excipients. − Conditions where the effects of Ventavis on platelets might increase the risk of haemorrhage (e. g. active peptic ulcers, trauma, intracranial haemorrhage). − Severe coronary heart disease or unstable angina; − Myocardial infarction within the last six months; − Decompensated cardiac failure if not under close medical supervision;
- stanja, pri katerih bi se lahko zaradi učinka zdravila Ventavis na trombocite povečalo tveganje
4 − Severe arrhythmias; cerebrovascular events (e. g. transient ischaemic attack, stroke) within the last 3 months. − Pulmonary hypertension due to venous occlusive disease. − Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension. − Pregnancy and lactation (see section 4.6).
za pojav krvavitev (npr. aktivna želodčna razjeda, poškodba, intrakranialna krvavitev)
4.4 Special warnings and precautions for use
- dekompenzirano srčno popuščanje, ki ni pod zdravniškim nadzorom
The use of Ventavis is not recommended in patients with unstable pulmonary hypertension, with advanced right heart failure.
- prirojene ali pridobljene okvare zaklopk s klinično pomembno motnjo v delovanju srca, ki ni v
In case of deterioration or worsening of right heart failure transfer to other medicinal products should be considered.
V primeru napredovanja ali poslabšanja desnostranskega srčnega popuščanja je treba razmisliti o možnosti uporabe kakega drugega zdravila.
The pulmonary vasodilatory effect of inhaled iloprost is of short duration (one to two hours).
Vazodilatorni učinek inhaliranega iloprosta v pljučih je kratkotrajen (eno do dve uri).
Patients who experience syncope in association with pulmonary hypertension should avoid any exceptional straining, for example during physical exertion.
Bolniki, pri katerih se kot posledica pljučne hipertenzije pojavlja kratkotrajna izguba zavesti (sinkopa), naj se izogibajo pretiranim naporom, npr. fizičnim obremenitvam.
Before physical exertion it might be useful to inhale.
Pred fizičnimi napori je koristno inhalirati.
The occurrence of a nocturnal or exertional syncope reflects therapeutic gaps and/ or insufficient efficiency, and the need to adapt and/ or change the therapy should be considered (see section 4.8).
Pojav nočnih sinkop ali sinkop ob obremenitvenih je znak nezadostnega ali premalo učinkovitega zdravljenja, zato je treba razmisliti o prilagoditvi in/ ali spremembi obstoječega zdravljenja (glejte poglavje 4. 8).
Ventavis inhalation might entail the risk of inducing bronchospasm, especially in patients with bronchial hyperactivity (see section 4.8 Undesirable effects).
Zdravilo Ventavis lahko povzroči tveganje za bronhospazem, predvsem pri bolnikih z bronhialno hiperaktivnostjo (glejte poglavje 4. 8 Neželeni učinki).
Moreover, the benefit of Ventavis has not been established in patients with concomitant Chronic Obstructive Pulmonary Disease (COPD) and severe asthma.
Pri bolnikih s sočasno kronično obstruktivno pljučno boleznijo (KOPB) in hudo astmo koristnost zdravila Ventavis ni bila ugotovljena.
Patients with concomitant acute pulmonary infections, COPD and severe asthma should be carefully monitored.
Bolnike s sočasnimi akutnimi pljučnimi okužbami, KOPB in hudo astmo je treba skrbno nadzorovati.
In patients with low systemic blood pressure, care should be taken to avoid further hypotension.
Pri bolnikih s nizkim sistemskim krvnim tlakom je treba paziti, da ne bi prišlo do nadaljnje hipotenzije.
Ventavis should not be initiated in patients with systolic arterial hypotension less than 85 mmHg.
Zdravila Ventavis se ne sme uporabljati pri bolnikih, ki imajo sistolni arterijski tlak nižji od 85 mmHg.
Should signs of pulmonary oedema occur when inhaled iloprost is administered in patients with pulmonary hypertension, the possibility of associated pulmonary veno-occlusive disease should be considered.
Če se pri bolnikih s pljučno hipertenzijo med inhalacijo iloprosta pojavijo znaki pljučnega edema, je treba pomisliti na možnost pridružene pljučne venske okluzivne bolezni.
The treatment should be stopped.
Zdravljenje je treba prenehati.
Careful monitoring of the patient should be performed, when inhaled iloprost therapy is stopped and an alternative treatment should be considered in critically ill patients.
Ob ukinitvi zdravljenja z inhaliranjem iloprosta je pri kritično bolnih osebah potreben skrben nadzor in uvedba morebitnega alternativnega zdravljenja.
Iloprost elimination is reduced in patients with hepatic dysfunction and in patients with renal failure requiring dialysis (see section 5.2).
Pri bolnikih z okvaro jeter kot tudi pri tistih z okvaro ledvic, ki zahteva zdravljenje z dializo, je izločanje iloprosta zmanjšano (glejte poglavje 5. 2).
A cautious initial dose titration using dosing intervals of at least 3 hours is recommended (see section 4.2).
Priporočljivo je, da se začetni odmerek titrira previdno, interval med posameznimi odmerki pa naj ne bo krajši od 3 ur (glejte poglavje 4. 2).
It cannot be excluded that this is also relevant to man on prolonged Ventavis therapy.
Ni izključeno, da to velja tudi za dolgotrajno zdravljenje z zdravilom Ventavis pri človeku.
To minimise accidental exposure, it is recommended to use Ventavis with nebulisers with inhalation- triggered systems (HaloLite/ Prodose), and to keep the room well ventilated.
Za zmanjšanje nenamerne izpostavljenosti je priporočljivo uporabljati zdravilo Ventavis z nebulatorji, ki imajo sistem za aktivacijo ob inhalaciji (HaloLite/ Prodose) in poskrbeti za dobro zračenje prostora.
Ventavis nebuliser solution should not come into contact with skin and eyes; oral ingestion of Ventavis solution should be avoided.
Ventavis inhalacijska raztopina za nebulator ne sme priti v stik s kožo in očmi; izogibati se je treba peroralnemu zaužitju Ventavis inhalacijske raztopine za nebulator.
During nebulisation sessions a facial mask must be avoided and only a mouthpiece should be used.
Med inhalacijo z nebulatorjem se je treba izogibati nošenju obrazne maske in uporabljati le ustnik.
Iloprost may increase the effect of vasodilatators and antihypertensive agents.
Iloprost lahko poveča učinek vazodilatatorjev in antihipertenzivov.
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 lahko zavira delovanje trombocitov in njegova uporaba v kombinaciji z antikoagulanti (kot so heparin in kumarini) ali z drugimi zaviralci agregacije trombocitov (npr. acetilsalicilna kislina, nesteroidna protivnetna zdravila, tiklopidin, klopidogrel in antagonisti glikoproteinov IIb/ IIIa: abciksimab, eptifibatid in tirofiban) lahko poveča tveganje za pojav krvavitev.
A careful monitoring of the patients taking anticoagulants according to common medical practice is recommended.
V skladu s splošno klinično prakso je priporočljivo skrbno spremljati bolnike, ki prejemajo antikoagulante.
The concomitant use of other platelet inhibitors should be avoided in patients taking anticoagulants.
Pri bolnikih, ki prejemajo antikoagulante, se je treba izogibati sočasni uporabi drugih zaviralcev trombocitov.
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.
5 Intravenska infuzija iloprosta pri bolnikih ne vpliva na farmakokinetiko večkratnih odmerkov digoksina, kot tudi ne na farmakokinetiko sočasno apliciranega tkivnega aktivatorja plazminogena (t - PA).
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.
Čeprav kliničnih študij niso opravljali, so študije in vitro, v katerih so proučevali zaviralne lastnosti iloprosta na delovanje encimov citokroma P450, pokazale, da ni pričakovati, da bi zaradi iloprosta ti encimi imeli pomembnejši zaviralni učinek na presnovo zdravil.
There are no adequate data from the use of Ventavis in pregnant women.
Ni ustreznih podatkov o uporabi zdravila Ventavis pri nosečnicah.
Animal studies have shown reproductive toxicity (see section 5.3).
V študijah na živalih je bila ugotovljena reproduktivna toksičnost (glejte poglavje 5. 3).
Ventavis is contra- indicated during pregnancy (see section 4.3).
Uporaba zdravila Ventavis med nosečnostjo je kontraindicirana (glejte poglavje 4. 3).
Women of child-bearing potential should use effective contraceptive measures during treatment.
Ženske v rodnem obdobju morajo med zdravljenjem uporabljati učinkovito kontracepcijo.
It is not known whether Ventavis enters the breast milk.
Ni znano, ali se zdravilo Ventavis izloča z materinim mlekom.