natgillin/translations-raw huggingface dataset:
If you are starting Ventavis treatment or if you switch from an alternative device your first inhalation will be with Ventavis 10 microgram/ml (1 ml ampoule with white and yellow rings).
Ako započinjete liječenje lijekom Ventavis ili prelazite s uporabe drugog uređaja Vaša prva inhalacija bit će s lijekom Ventavis od 10 mikrograma/ml (ampula od 1 ml s bijelim i žutim prstenom).
• Ventavis 20 microgram/ml:
• Ventavis 20 mikrograma/ml:
• For the inhalation you should use a mouthpiece to prevent Ventavis coming into contact with your skin.
• Kako bi se spriječilo da Ventavis dođe u kontakt s kožom, pri inhalaciji je potrebno koristiti nastavak za usta.
Ventavis 20 microgram/ml is provided in colourless ampoules, containing 1 ml nebuliser solution.
Ventavis 20 mikrograma/ml je dostupan u bezbojnim ampulama koje sadrže 1 ml otopine za nebulizator.
Ventavis 10 microgram/ml (1 ml ampoule) and Ventavis 20 microgram/ml nebuliser solution
Ventavis 10 mikrograma/ml (ampula od 1 ml) i Ventavis 20 mikrograma/ml otopina za nebulizator
Ventavis 20 microgram/ml nebuliser solution 5 years.
Ventavis 20 mikrograma/ml otopina za nebulizator 5 godina.
Multipack: 300 (10 x 30) ampoules with 2 ml.
Višestruko pakiranje: 300 (10 x 30) ampula s 2 ml.
168 (4 x 42) AMPOULES WITH 1 ML
168 (4 x 42) AMPULA S 1 ML
No disturbance of post-natal development and reproductive performance was seen in animals exposed during lactation.
U životinja izloženih lijeku tijekom laktacije nije uočen poremećaj u postnatalnom razvoju i reprodukciji.
This nebuliser monitors the breathing pattern to determine the aerosol pulse time required to deliver the pre-set dose of 2.5 or 5 microgram iloprost.
Ovim nebulizatorom prati se obrazac disanja kako bi se odredilo vrijeme impulsa za aerosol potrebno za isporuku unaprijed određene doze iloprosta od 2,5 ili 5 mikrograma.
Iloprost may increase the effects of vasodilatators and antihypertensive agents and then favour the risk of hypotension (see section 4.4).
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Iloprost može pojačati učinke vazodilatora i antihipertenzivnih lijekova i tako pridonijeti riziku od hipotenzije (vidjeti dio 4.4).
No tumourigenic potential of iloprost was observed in tumourigenicity studies in rats and mice.
U ispitivanjima tumorogenosti na štakorima i miševima nije uočen tumorogeni potencijal iloprosta.
Dose of iloprost at mouthpiece
Doza iloprosta u nastavku za usta
The ampoules containing 1 ml are marked with two coloured rings (white - yellow).
Ampule koje sadrže 1 ml označene su s dva prstena u boji (bijeli - žuti).
Close supervision by the treating physician is necessary if switching from Ventavis 10 microgram/ml to Ventavis 20 microgram/ml to control the acute tolerance relating to faster delivery rate of iloprost with the double concentration.
Ako se prelazi s lijeka Ventavis 10 mikrograma/ml na Ventavis 20 mikrograma/ml, neophodan je pomni nadzor nadležnog liječnika zbog kontrole akutne podnošljivosti vezano uz bržu primjenu iloprosta pri dvostrukoj koncentraciji.
The pre-set dose provided by the I-Neb AAD nebuliser is controlled by the medication chamber in combination with a control disc.
Unaprijed određenu dozu koja se primjenjuje putem I-Neb AAD nebulizatora kontrolira komora za lijek u kombinaciji s kontrolnim diskom.
• chest discomfort / chest pain
• nelagoda/bol u prsnom košu
This nebuliser monitors the breathing pattern to determine the aerosol pulse time required to deliver the pre-set dose of 5 micrograms iloprost of the Ventavis 20 microgram/ml nebuliser solution (1 ml ampoule with yellow and red rings).
Ovaj nebulizator prati obrazac disanja kako bi se odredilo vrijeme impulsa za aerosol potrebno za isporuku unaprijed određene doze od 5 mikrograma iloprosta iz Ventavis 20 mikrograma/ml otopine za nebulizator
If you tolerate this dose well, your dose should be increased to 5 microgram and you should continue on this dose.
Ako dobro podnosite tu dozu, Vašu dozu je potrebno povećati na 5 mikrograma i nastaviti s tom dozom.
The ampoules containing 1 ml are marked with two coloured rings (yellow-red).
Ampule s 1 ml označene su s dva prstena u boji (žuti-crveni).
The pre-set dose provided by the I-Neb AAD system is controlled by the medication chamber in combination with a control disc.
Dozu koja se primjenjuje putem sustava I-Neb AAD kontrolira komora za lijek u kombinaciji s kontrolnim diskom.
Multipack containing 168 (4x42) ampoules for use with the Breelib and I-Neb nebuliser.
Višestruko pakiranje sadrži 168 (4x42) ampula za primjenu pomoću nebulizatora Breelib i I-Neb.
Cmax and AUC (0-tlast) after inhalation of 5 microgram iloprost administered as Ventavis 20 microgram/ml using the Breelib were 77% and 42%, respectively higher compared to inhalation of the same dose using Ventavis 10 microgram/ml and the I-Neb AAD system.
20 mikrograma/ml pomoću nebulizatora Breelib bila je 77%, odnosno 42% veća u usporedbi s inhalacijom iste doze primjenom lijeka Ventavis 10 mikrograma/ml pomoću sustava I-Neb AAD.
Pack containing 30 or 42 ampoules for use with the Breelib and I-Neb nebuliser.
- Pakiranje s 30 ampula ili 42 ampule za primjenu pomoću nebulizatora Breelib ili I-Neb.
Multipack: 90 (3 x 30) ampoules with 2 ml.
Višestruko pakiranje: 90 (3 x 30) ampula s 2 ml.
For each inhalation session the content of one opened ampoule of Ventavis has to be transferred completely into the medication chamber immediately before use.
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Prilikom svake inhalacije, sadržaj jedne otvorene ampule lijeka Ventavis mora se neposredno prije primjene u potpunosti prenijeti u komoru za lijek.
Package leaflet: Information for the user Ventavis 20 microgram/ml nebuliser solution
Uputa o lijeku: Informacije za korisnika Ventavis 20 mikrograma/ml otopina za nebulizator iloprost
Ventavis 10 microgram/ml nebuliser solution 4 years.
Ventavis 10 mikrograma/ml otopina za nebulizator 4 godine.
Bayer d. o. o. Tel.: +386 (0)1 58 14 400
Tel.: +386 (0)1 58 14 400
This nebuliser monitors the breathing pattern to determine the aerosol pulse time required to deliver the pre-set dose of 5 microgram iloprost.
Ovim nebulizatorom prati se obrazac disanja da bi se odredilo vrijeme impulsa za aerosol potrebno za isporuku unaprijed određene doze iloprosta od 5 mikrograma.
Nebuliser solution.
Otopina za nebulizator.
• 90 (3x30) ampoules
• 90 (3x30) ampula • 300 (10x30) ampula.
Interruption of therapy
Prekid liječenja
Package leaflet: Information for the user Ventavis 10 microgram/ml nebuliser solution
Uputa o lijeku: Informacije za korisnika Ventavis 10 mikrograma/ml otopina za nebulizator iloprost
Bayer plc Tel: +44 (0)118 206 3000
Tel: +44 (0) 118 206 3000
If this dose is well tolerated, dosing should be increased to 5 microgram iloprost using 1 ml ampoule of Ventavis 10 microgram/ml and maintained at that dose.
Ako se ta doza podnosi dobro, dozu je potrebno povećati i zadržati na dozi s 5 mikrograma iloprosta primjenom ampule od 1 ml lijeka Ventavis 10 mikrograma/ml.
• P1 Programme 1: 5 microgram active substance on the mouth piece 25 inhalation cycles.
• P1 program 1: 5 mikrograma djelatne tvari u nastavku za usta uz 25 ciklusa inhalacije.
Device
OBLIK
Using more Ventavis than you should may lead to dizziness, headache, flushing (reddening of the face), nausea (feeling sick), jaw pain or back pain.
Ako primijenite više lijeka Ventavis nego što ste trebali Uzimanje veće količine lijeka Ventavis od potrebne može dovesti do omaglice, glavobolje, naleta crvenila (crvenilo lica), mučnine, boli u čeljusti ili boli u leđima.
For Ventavis 20 microgram/ml (5 microgram dose), the medication chamber with the golden coloured latch is used together with the golden control disc.
Za Ventavis 20 mikrograma/ml (doza od 5 mikrograma) koristi se komora za lijek s jezičkom zlatne boje zajedno s kontrolnim diskom zlatne boje.
If you tolerate this dose well, your dose should be increased to 5 microgram iloprost and you should continue on this dose.
Ako dobro podnosite tu dozu, Vašu dozu je potrebno povećati na 5 mikrograma iloprosta i nastaviti s tom dozom.
The adverse reactions reported below are based on pooled clinical trial data from phase II and III clinical trials involving 131 patients taking the medicinal product and on data from post-marketing surveillance.
provedenim na 131 bolesniku koji je uzimao lijek i na podacima prikupljenim tijekom praćenja nakon stavljanja lijeka u promet.
In general, when starting Ventavis treatment the first inhaled dose should be 2.5 microgram iloprost as delivered at the mouthpiece.
Općenito, na početku liječenja lijekom Ventavis, prva doza koja se inhalira mora biti 2,5 mikrograma iloprosta dostavljena putem nastavka za usta.
1 ml solution contains 10 microgram iloprost (as iloprost trometamol).
1 ml otopine sadrži 10 mikrograma iloprosta (u obliku iloprosttrometamola).
Ventavis 10 microgram/ml; 2 ml
Ventavis 10 mikrograma/ml; 2 ml
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
U KARTONSKOJ KUTIJI S 90 (3 x 30) AMPULA S 2 ML PAKIRANJE S 30 AMPULA
• P2 Programme 2: 2.5 microgram active substance on the mouth piece 10 inhalation cycles.
• P2 program 2: 2,5 mikrograma djelatne tvari u nastavku za usta uz 10 ciklusa inhalacije.
42 ampoules with 1 ml.
42 ampule s 1 ml.
Ventavis 10 microgram/ml nebuliser solution (1 ml ampoule)
Ventavis 10 mikrograma/ml otopina za nebulizator (ampula od 1 ml)
For administration with the Breelib.
Za primjenu pomoću nebulizatora Breelib.
1 ml solution contains 20 microgram iloprost (as iloprost trometamol).
1 ml otopine sadrži 20 mikrograma iloprosta (u obliku iloprosttrometamola).
P2 Programme 2: 2.5 microgram active substance on the mouth piece 10 inhalation cycles.
P2 program 2: 2,5 mikrograma djelatne tvari u nastavku za usta uz 10 ciklusa inhalacije.
For the 2.5 microgram dose of Ventavis 10 microgram/ml the medication chamber with the red coloured latch is used together with the red control disc.
Za dozu od 2,5 mikrograma lijeka Ventavis 10 mikrograma/ml koristi se komora za lijek s crvenim jezičkom u kombinaciji s crvenim kontrolnim diskom.
Ventavis 20 microgram/ml; 1 ml
Ventavis 20 mikrograma/ml; 1 ml
• 168 (4x42) ampoules co-packed with Breelib consumables set (containing 1 mouthpiece and 1
• 168 (4 x 42) ampula pakiranih zajedno sa zamjenskim setom Breelib (sadrži 1 nastavak za usta i
42 AMPOULES WITH 1 ML
42 ampule s 1 ml
Multipack: 168 (4 x 42) ampoules with 1 ml.
Višestruko pakiranje:168 (4 x 42) ampula s 1 ml.
Ampoules with 2 ml nebuliser solution (for the use of Venta-Neb):
Ampule s 2 ml otopine za nebulizator (za primjenu pomoću uređaja Venta-Neb): Pakiranja sadrže:
• 3 ml ampoules, colourless, glass type I, containing 2 ml nebuliser solution, ring coded with two coloured rings (white - pink).
• ampule od 3 ml, od bezbojnog stakla tipa I, s 2 ml otopine za nebulizator, označene s dva prstena u različitim bojama (bijeli - ružičasti).
Inhalation use.
Za inhaliranje
• For the 2.5 microgram dose the medication chamber with the red latch is used together with the red control disc.
• Za dozu od 2,5 mikrograma koristi se komora za lijek s crvenim jezičkom u kombinaciji s crvenim kontrolnim diskom.
Just before you start to inhale, break the glass ampoule containing 2 ml solution, which has two coloured rings (white-pink), and pour the complete contents into the nebuliser medication chamber.
Neposredno prije početka inhalacije, prelomite staklenu ampulu koja sadrži 2 ml otopine i označena je s dva prstena u boji (bijeli - ružičasti) i sav sadržaj izlijte u komoru za lijek u nebulizatoru.
Ventavis 10 microgram/ml; 1 ml
Ventavis 10 mikrograma/ml; 1 ml
Part of a multipack containing 168 (4 x 42) ampoules with 1 ml co-packed with Breelib consumables set (containing 1 mouthpiece and 1 medication chamber).
Dio višestrukog pakiranja koje sadrži 168 (4 x 42) ampula s 1 ml pakiranih zajedno sa zamjenskim setom Breelib (sadrži 1 nastavak za usta i 1 komoru za lijek).
Tel: +420 266 101 111
Bayer s.r.o. Tel: +420 266 101 111
Just before you start to inhale, break the glass ampoule containing 1 ml solution, which has two coloured rings (white - yellow), and pour the complete contents into the nebuliser medication chamber.
Neposredno prije početka inhalacije, prelomite staklenu ampulu koja sadrži 1 ml otopine i označena je s dva prstena u boji (bijeli - žuti) i sav njezin sadržaj izlijte u komoru za lijek u nebulizatoru.
90 ampoules with 2 ml.
90 ampula s 2 ml.
30 ampoules with 2 ml.
30 ampula s 2 ml.
• nausea
• kašalj
• 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.
nesteroidne protuupalne lijekove, neselektivne inhibitore fosfodiesteraze, kao što je pentoksifilin, selektivne inhibitore fosfodiesteraze 3 (PDE 3), kao što su cilostazol ili anagrelid,
The I-Neb AAD nebuliser has been shown to be suitable for the administration of Ventavis 10 microgram/ml (1 ml ampoule with white and yellow rings).
AAD pokazao se prikladnim za primjenu lijeka Ventavis 10 mikrograma/ml (ampula od 1 ml s bijelim i žutim prstenom).
100 ampoules with 2 ml.
100 ampula s 2 ml.
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
S 2 ML 90 (3 x 30) AMPULA S 2 ML 100 AMPULA
At initiation of Ventavis treatment with I-Neb system the first inhaled dose should be 2.5 microgram iloprost as delivered at the mouthpiece of the nebuliser using 1 ml ampoule of Ventavis 10 microgram/ml.
Na početku liječenja lijekom Ventavis s I-Neb sustavom, prva doza koja se inhalira je 2,5 mikrograma iloprosta dostavljena putem nastavka za usta nebulizatora primjenom ampule od 1 ml lijeka Ventavis
Ventavis 20 microgram/ml nebuliser solution 1 ml solution contains 20 microgram iloprost (as iloprost trometamol).
Ventavis 20 mikrograma/ml otopina za nebulizator 1 ml otopine sadrži 20 mikrograma iloprosta (u obliku iloprosttrometamola).
Dose of iloprost at Estimated inhalation time mouthpiece
Procijenjeno trajanje inhalacije u nastavku za usta
If you get any side effects talk to your doctor.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.
Ventavis 10 microgram/ml nebuliser solution 1 ml solution contains 10 microgram iloprost (as iloprost trometamol).
Ventavis 10 mikrograma/ml otopina za nebulizator 1 ml otopine sadrži 10 mikrograma iloprosta (u obliku iloprosttrometamola).
• 1 ml ampoules, colourless, glass type I, containing 1 ml nebuliser solution, ring coded with two coloured rings (yellow - red).
• ampule od 1 ml, od bezbojnog stakla tipa I, s 1 ml otopine za nebulizator, označene s dva prstena u različitim bojama (žuti - crveni).
Each ampoule with 2 ml contains 20 microgram iloprost.
Svaka ampula s 2 ml otopine sadrži 20 mikrograma iloprosta.
• I-Neb nebuliser
• Nebulizator I-Neb
For each inhalation session with the I-Neb AAD, the content of one 1-ml ampoule of Ventavis 20 microgram/ml, showing two coloured rings (-yellow-red), will be transferred into the appropriate nebuliser medication chamber with golden coloured latch together with the golden colour disc immediately before use.
Za svaku inhalaciju pomoću sustava I-Neb AAD sadržaj jedne ampule od 1 ml lijeka Ventavis 20 mikrograma/ml označene s dva prstena u boji (žuti-crveni) premješta se u odgovarajuću komoru za lijek s jezičkom zlatne boje zajedno s diskom zlatne boje neposredno prije primjene.
Moreover, the benefit of Ventavis has not been established in patients with concomitant Chronic Obstructive Pulmonary Disease (COPD) and severe asthma.
Nadalje, u bolesnika s popratnom kroničnom opstruktivnom bolesti pluća (KOPB) i teškom astmom nije utvrđena korist lijeka Ventavis.
Multipack: 168 (4 x 42) ampoules with 1 ml co-packed with Breelib consumables set (containing 1 mouthpiece and 1 medication chamber).
Višestruko pakiranje: 168 (4 x 42) ampula s 1 ml pakiranih zajedno sa zamjenskim setom Breelib (sadrži 1 nastavak za usta i 1 komoru za lijek).
Polígono Industrial Santa Rosa s/n 28806 Alcalá de Henares Madrid
Berlimed S.A. Polígono Industrial Santa Rosa s/n
300 ampoules with 2 ml.
300 ampula s 2 ml.
No reliable conclusion could be drawn on efficacy of the association as the sample size was limited and the study was of short duration.
Zbog ograničene veličine uzorka i kratkog trajanja ispitivanja ne može se donijeti pouzdan zaključak o djelotvornosti te kombinacije lijekova.
Each ampoule with 1 ml contains 10 microgram iloprost.
Svaka ampula s 1 ml otopine sadrži 10 mikrograma iloprosta.
Ventavis 20 mcg/ml 1 ml ampoule yellow-red ring
Ventavis 20 mikrograma/ml ampula od 1 ml žuti-crveni prsten
EU/1/03/255/013 [168 (4 x 42) x 1 ml] co-packed with Breelib consumables set (containing 1 mouthpiece and 1 medication chamber).
EU/1/03/255/013 [168 (4 x 42) x 1 ml] pakirano zajedno sa zamjenskim setom Breelib (sadrži 1
Ventavis 10 mcg/ml (1 ml ampoule with white and yellow rings)
Ventavis 10 µg/ml (ampula od 1 ml s bijelim i žutim prstenom)
4.2 Posology and method of administration Drug product
4.2 Doziranje i način primjene
Ventavis 20 mcg/ml (1 ml ampoule with yellow and red rings)
Ventavis 20 µg/ml (ampula od 1 ml sa žutim i crvenim prstenom)
At initiation of Ventavis treatment the first inhaled dose should be 2.5 microgram iloprost as delivered at the mouthpiece of the nebuliser.
Na početku liječenja lijekom Ventavis, prva doza koja se inhalira je 2,5 mikrograma iloprosta dostavljena putem nastavka nebulizatora za usta.
Ventavis 20 microgram/ml
Ventavis 20 mikrograma/ml.
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).
U bolesnika čiji je klirens kreatinina veći od 30 ml/min (utvrđen iz serumskog kreatinina pomoću
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET • Periodička izvješća o neškodljivosti
• 1 ml ampoules, colourless, glass type I, containing 1 ml nebuliser solution, ring coded with two coloured rings (white - yellow).
• ampule od 1 ml, od bezbojnog stakla tipa I, s 1 ml otopine za nebulizator, označene s dva prstena u različitim bojama (bijeli - žuti).
For the 5 microgram dose of Ventavis 20 microgram/ml the medication chamber with the gold coloured latch is used together with the gold control disc.
Za dozu od 5 mikrograma lijeka Ventavis 20 mikrograma/ml koristi se komora za lijek sa zlatnim jezičkom u kombinaciji sa zlatnim kontrolnim diskom.
Trometamol
trombocitopenija
- Multipack containing 168 (4x42) ampoules for use with the Breelib and I-Neb nebuliser.
- Višestruko pakiranje s 168 (4 x 42) ampula za primjenu pomoću nebulizatora Breelib ili I-Neb.
Ventavis 10 microgram/ml nebuliser solution Ventavis 20 microgram/ml nebuliser solution
Ventavis 10 mikrograma/ml otopina za nebulizator Ventavis 20 mikrograma/ml otopina za nebulizator
- Multipack containing 168 (4x42) ampoules with Breelib consumables set (containing 1
- Višestruko pakiranje sadrži 168 (4x42) ampula sa zamjenskim setom za Breelib (sadrži
If this dose is well tolerated, dosing should be increased to 5 microgram iloprost and maintained at that dose.
Ako se ta doza podnosi dobro, doziranje je potrebno povećati i zadržati na dozi s 5 mikrograma iloprosta.
If this dose is well tolerated, dosing should be increased to 5 microgram iloprost using 2 ml ampoule of Ventavis 10 microgram/ml and maintained at that dose.
Ako se ta doza podnosi dobro, doziranje se treba povećati i zadržati na dozi s 5 mikrograma iloprosta korištenjem ampule od 2 ml lijeka Ventavis 10
Ventavis 20 microgram/ml is available in the following packs: - Pack containing 30 ampoules or 42 ampoules for use with the Breelib and I-Neb nebuliser.
• ampule od 1 ml za primjenu pomoću nebulizatora Breelib ili I-Neb: − Pakiranje sadrži 30 ili 42 ampule za primjenu pomoću nebulizatora Breelib i I-Neb.
For each medication chamber there is a corresponding colour coded control disc:
Svaka komora za lijek obilježena je odgovarajućom bojom i ima kontrolni disk označen tom istom odgovarajućom bojom.
Each ampoule with 1 ml contains 20 microgram iloprost.
Svaka ampula s 1 ml otopine sadrži 20 mikrograma iloprosta.
For each inhalation session with the I-Neb AAD, the content of one 1 ml ampoule of Ventavis 20 microgram/ml with two coloured rings (yellow - red), is transferred into the medication chamber immediately before use.
Za svaku inhalaciju pomoću I-Neb AAD sadržaj jedne ampule od 1 ml lijeka Ventavis 20 mikrograma/ml označene s dva prstena u boji (žuti - crveni), premješta se u komoru za lijek neposredno prije primjene.
Ventavis 10 mcg/ml 1 ml ampoule white - yellow ring
Ventavis 10 µg/ml ampula od 1 ml bijeli - žuti prsten
For each inhalation session with the I-Neb AAD, the content of one 1 ml ampoule of Ventavis, with two coloured rings (white - yellow) is transferred into the medication chamber immediately before use.
Za svaku inhalaciju pomoću I-Neb AAD sadržaj jedne ampule od 1 ml lijeka Ventavis označene s dva prstena u boji (bijeli - žuti), premješta se u komoru za lijek neposredno prije primjene.
EU/1/03/255/014 [168 (4 x 42) x 1 ml] co-packed with Breelib consumables set (containing 1 mouthpiece and 1 medication chamber).
EU/1/03/255/014 [168 (4 x 42) x 1 ml] pakirano zajedno sa zamjenskim setom Breelib (sadrži
Ventavis 10 mcg/ml 1 ml ampoule white-yellow ring
Ventavis 10 mikrograma/ml ampula od 1 ml bijeli-žuti prsten
No study has been performed with Ventavis in children with pulmonary hypertension.
Na djeci s plućnom hipertenzijom nije provođeno ispitivanje s lijekom Ventavis.
The I-Neb AAD nebuliser has been shown to be suitable for the administration of Ventavis 10 microgram/ml (1 ml ampoule) and 20 microgram/ml nebuliser solution.
AAD pokazao se prikladnim za primjenu Ventavis 10 mikrograma/ml (ampula od 1 ml) i
Different nebuliser devices can be used to administer Ventavis 20µg/ml.
Za primjenu lijeka Ventavis 20µg/ml mogu se koristiti različiti nebulizatori.
Blood pressure should be checked while initiating Ventavis.
Na početku liječenja lijekom Ventavis potrebno je kontrolirati krvni tlak.
• For the 5 microgram dose the medication chamber with the purple coloured latch is used together with the purple control disc.
• Za dozu od 5 mikrograma koristi se komora za lijek s ljubičasto obojenim jezičkom zajedno s ljubičastim kontrolnim diskom.
Only patients who are maintained at the 5 microgram dose and who have repeatedly experienced extended inhalation times with Ventavis 10 microgram/ml, which could result in incomplete inhalation, may be considered suitable for switching to Ventavis 20 microgram/ml.
Ventavis 20 mikrograma/ml otopina za nebulizator Prelazak na Ventavis 20 mikrograma/ml može se razmotriti samo u bolesnika koji su na održavanju dozom od 5 mikrograma i koji su opetovano imali produljeno vrijeme inhalacije s lijekom Ventavis 10 mikrograma/ml, što može rezultirati nepotpunom inhalacijom.
Ventavis 20 microgram/ml nebuliser solution
Ventavis 20 mikrograma/ml otopina za nebulizator
For each inhalation session, the content of one ampoule containing 2 ml of Ventavis 10 microgram/ml nebuliser solution and marked with two coloured rings (white - pink) is transferred into the nebuliser medication chamber immediately before use.
Neposredno prije svake pojedinačne inhalacije sadržaj jedne ampule od 2 ml Ventavis 10 mikrograma/ml otopine za nebulizator označene s dva prstena u boji (bijeli - ružičasti) premješta se u komoru za lijek u nebulizatoru.
• 1 ml ampoules for use with Breelib or I-Neb nebulisers:
• ampule od 2 ml za primjenu pomoću nebulizatora Venta-Neb:
What Ventavis looks like and content of the pack:
Moguće nuspojave Kako čuvati Ventavis Sadržaj pakiranja i druge informacije
168 (4 x 42) AMPOULES WITH 1 ML CO-PACKED WITH BREELIB CONSUMABLES SET
168 (4 x 42) AMPULA S 1 ML PAKIRANO ZAJEDNO SA ZAMJENSKIM