natgillin/translations-raw huggingface dataset:
• The nebuliser turns Ventavis solution into a mist which you breathe in through your mouth.
• Nebulator spremeni raztopino zdravila Ventavis v meglico, ki jo vdihnete skozi usta.
Women of childbearing potential should use effective contraceptive measures during treatment with Ventavis.
Ženske v rodni dobi morajo med zdravljenjem z zdravilom Ventavis uporabljati učinkovito kontracepcijsko metodo.
Two programmes can be operated: 3.
Na voljo sta dva programa.
• Increase of capillary density and reduction of increased vascular permeability caused by mediators such as serotonin or histamine in the microcirculation
• povečanje gostote kapilar in zmanjšanje povečane žilne permeabilnosti, ki jo povzročajo mediatorji kot so serotonin ali histamin v mikrocirkulaciji, • stimulacija endogene fibrinolize.
− Severe coronary heart disease or unstable angina.
- huda koronarna srčna bolezen ali nestabilna angina pektoris
The duration of an inhalation session with Breelib nebuliser is approximately 3 minutes, which reflects the higher delivery rate of the Breelib compared to other nebulisers.
Inhalacija z nebulatorjem Breelib traja približno 3 minute, kar kaže na večjo hitrost dovajanja zdravila z nebulatorjem Breelib v primerjavi z drugimi nebulatorji.
The pulmonary vasodilatory effect of inhaled iloprost is of short duration (one to two hours).
Vazodilatatorni učinek inhaliranega iloprosta v pljučih je kratkotrajen (ena do dve uri).
• awareness of fast or hard heartbeat (palpitations)
• občutek hitrega in močnega bitja srca (palpitacije)
Systemic exposures exceeded human therapeutic exposures after inhalation by factors of more than 10 (Cmax, cumulative AUC).
Po inhalaciji je sistemska izpostavljenost za več kot 10-krat presegla terapevtsko izpostavljenost po inhalaciji pri človeku (Cmax, kumulativni AUC).
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 kakšnega drugega zdravila.
If any of these happen when you have used more Ventavis than you should:
Če se pojavi kateri koli od teh simptomov, potem ko ste uporabili večji odmerek zdravila Ventavis, kot bi smeli:
During nebulisation sessions a facial mask must be avoided and only a mouthpiece should be used.
Med inhalacijo z nebulatorjem se je treba izogibati uporabi maske za obraz in uporabljati le ustnik.
Before taking any medicine ask your doctor or pharmacist, who has more information on medicines to be careful with or avoid when using Ventavis.
Preden začnete jemati katero koli zdravilo, se posvetujte z zdravnikom ali farmacevtom, ki imata več podatkov o tem, katerim zdravilom se je treba izogibati ali morate biti pri njihovem jemanju previdni,
If you forget to use Ventavis
Če ste pozabili uporabiti zdravilo Ventavis
Undesirable exposure to Ventavis
Neželena izpostavljenost zdravilu Ventavis
• If you have liver problems or very severe kidney problems, requiring dialysis, tell your doctor.
• Če imate težave z jetri ali hude ledvične težave, pri katerih je potrebna dializa, se posvetujte z zdravnikom.
Care should be exercised during initiation of therapy until any effects on the individual have been determined.
Pri uvedbi zdravljenja je potrebna previdnost, dokler ni ugotovljeno, kako le-to učinkuje na posameznika.
The following pharmacological effects have been observed in vitro:
V študijah in vitro so opazili naslednje farmakološke učinke:
A cautious initial dose titration using dosing intervals of 3-4 hours is recommended (see section 4.2).
Priporočljivo je, da se začetni odmerek titrira previdno, interval med posameznimi odmerki pa naj bo od 3 - 4 ure (glejte poglavje 4.2).
Breathing in the mist carries Ventavis to the lungs, where it can work most effectively in the artery between heart and lungs.
Z vdihavanjem meglice zdravila Ventavis pride le-to v pljuča, kjer lahko zelo učinkovito deluje na arterijo med srcem in pljuči.
Following intravenous infusion, the recovery of total radioactivity is 81 %, and the respective recoveries in urine and faeces are 68% and 12%.
Po intravenski infuziji je celokupna radioaktivnost 81 %, v seču 68 % in v blatu 12 %.
After intravenous administration, iloprost is extensively metabolised via ß-oxidation of the carboxyl side chain.
Po intravenski uporabi se iloprost presnavlja preko ß-oksidacije karboksilne stranske verige.
Bleeding events (mostly epistaxis and haemoptysis) were very common as expected in this patient population with a high proportion of patients taking anticoagulant co-medication.
Krvavitve (najpogosteje epistaksa in hemoptiza) so bile kot pričakovano zelo pogoste pri tistih populacijah bolnikov, v katerih velik delež bolnikov sočasno jemlje tudi antikoagulante.
Therefore, the same dosing recommendations as in patients with hepatic impairment (see above) are to be applied.
Zato glede odmerjanja veljajo ista priporočila kot za bolnike z okvaro jeter (glejte zgoraj).
In an intravenous study, results were obtained involving 8 patients suffering from liver cirrhosis.
V študiji intravenske uporabe so dobili izsledke pri 8 bolnikih z jetrno cirozo.
• Do NOT drink or swallow Ventavis solution.
• NE pijte raztopine Ventavis.
It imitates a natural substance in the body called prostacyclin.
Le-ta posnema delovanje naravne snovi v telesu, imenovane prostaciklin.
Following intravenous infusion, the apparent steady-state volume of distribution was 0.6 to 0.8 l/kg in healthy subjects.
Po intravenski infuziji je bil navidezni volumen porazdelitve v stanju dinamičnega ravnovesja pri zdravih osebah 0,6 do 0,8 l/kg.
If you have very severe kidney problems and require dialysis or if you have liver problems, your doctor will introduce you to Ventavis gradually and possibly prescribe fewer daily inhalations.
Če imate zelo hudo okvaro ledvic ali potrebujete dializo ter v primeru okvare jeter, vam bo zdravnik uvedel zdravljenje z zdravilom Ventavis postopoma in vam morda predpisal manj inhalacij na dan.
108 of the patients included were diagnosed with primary pulmonary hypertension, 95 were diagnosed with secondary pulmonary hypertension of which 56 were associated with chronic thromboembolic disease, 34 with connective tissue disease (including CREST and scleroderma) and 4 were considered appetite suppressant medicinal product related.
Od vključenih bolnikov jih je 108 imelo diagnozo primarne pljučne hipertenzije, 95 pa diagnozo sekundarne pljučne hipertenzije, ki je bila pri 56 bolnikih povezana s kronično tromboembolijo, pri 34 z obolenjem vezivnih tkiv (vključno s CREST in sklerodermijo), pri 4 pa z zdravili za zmanjševanje apetita.
Should patients deteriorate on this treatment intravenous prostacyclin treatment should be considered.
Če bi se bolnikovo stanje ob tem zdravljenju poslabšalo, je treba razmisliti o možnosti intravenske aplikacije prostaciklina.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON WITHOUT BLUE BOX
PODATKI NA ZUNANJI OVOJNINI NOTRANJA ŠKATLA BREZ MODREGA OKENCA
Your doctor may change the dosage.
Morda vam bo zdravnik spremenil odmerek zdravila.
• breathing difficulties (dyspnoea)
• težave z dihanjem (dispneja)
A dermal sensitisation (maximisation test) and an antigenicity study in guinea pigs showed no sensitising potential.
Kožna senzibilizacija (maksimizacijski test) in študije antigenosti pri morskih prašičkih niso pokazali senzibilizacijskega učinka.
In acute toxicity studies, single intravenous and oral doses of iloprost caused severe symptoms of intoxication or death (intravenous) at doses about two orders of magnitude above the intravenous therapeutic dose.
V študijah akutne toksičnosti so enkratni intravenski in peroralni odmerki iloprosta povzročili hude simptome zastrupitve ali smrt (intravenski) pri odmerkih, ki so približno dvakrat presegali intravenske terapevtske odmerke.
The increased occurrence of syncope can be related to the deterioration of the disease or insufficient effectiveness of the product (see section 4.4).
Večja pogostnost sinkope je lahko povezana z napredovanjem bolezni ali nezadostno učinkovitostjo zdravila (glejte poglavje 4.4).
Iloprost, the active substance of Ventavis, is a synthetic prostacyclin analogue.
Iloprost, učinkovina zdravila Ventavis, je sintetični analog prostaciklina.
Common (≥1/100 to <1/10)
zelo pogosti pogosti (≥ 1/100 do < 1/10)
Tell your doctor if you are taking any other medication because the combined effect with Ventavis may lower your blood pressure further (see below “Other medicines and Ventavis”).
Obvestite zdravnika, če jemljete katero koli drugo zdravilo, saj lahko sočasna uporaba z zdravilom Ventavis dodatno zniža krvni tlak (glejte spodaj, »Druga zdravila in zdravilo
Following inhalation of these doses with the Breelib the maximum plasma concentrations (Cmax) and systemic exposures (AUC (0-tlast)) increased dose-proportionally.
Po inhalaciji teh odmerkov z nebulatorjem Breelib so opazili, da so največje plazemske koncentracije (Cmax) in sistemska izpostavljenost (AUC (0-tlast)) povečale glede na velikost odmerka.
Syncope§ (see section 4.4) Hypotension*
Žilne bolezni vazodilatacija pordevanje sinkopa§ (glejte poglavje 4.4) hipotenzija*
When using the Breelib nebuliser please follow the instructions for use provided with the device.
Ko uporabljate nebulator Breelib, upoštevajte navodila za uporabo, priložena temu pripomočku.
What you need to know before you use Ventavis Do not use Ventavis
Kaj morate vedeti, preden boste uporabili zdravilo Ventavis Ne uporabljajte zdravila Ventavis
It is not known whether Ventavis passes into human milk.
Ni znano, če zdravilo Ventavis prehaja v materino mleko.
Fill the medication chamber with Ventavis immediately before use.
Prostor za zdravilo napolnite z zdravilom Ventavis tik pred uporabo.
• Any Ventavis solution remaining in the nebuliser after inhalation must be thrown away (see section 5).
• Vso raztopino zdravila Ventavis, ki po inhalaciji ostane v nebulatorju, je treba zavreči (glejte poglavje 5).
It cannot be excluded that this is also relevant to humans on prolonged Ventavis therapy.
Ni izključeno, da to velja tudi za dolgotrajno zdravljenje z zdravilom Ventavis pri človeku.
In order to ensure that you receive the prescribed dose, check the colour of the medication chamber and the colour of the control disc.
Da boste zagotovo prejeli predpisani odmerek, preverite barvo prostora za zdravilo in barvo nadzornega diska.
No studies performed following inhalation.
Študij po inhaliranju niso izvedli.
In vitro (bacterial, mammalian cells, human lymphocytes) and in vivo studies (micronucleus test) for genotoxic effects have not produced any evidence for a mutagenic potential.
Študije genotoksičnosti in vitro (bakterijske celice, celice sesalcev in humani limfociti) in in vivo (mikronukleusni test) niso pokazale mutagenega potenciala.
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.
Analiza po podskupinah je pokazala, da pri podskupini s sekundarno hipertenzijo v primerjavi s placebom ni bilo opaziti učinka zdravljenja na 6-minutni test hoje.
Thereafter, your doctor may cautiously shorten the dosing intervals depending on how you tolerate the treatment.
Nato lahko zdravnik previdno skrajša intervale med posameznimi odmerki, glede na to, kako dobro prenašate zdravilo.
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.
Intravenska infuzija iloprosta pri bolnikih ne vpliva na farmakokinetiko večkratnih peroralnih odmerkov digoksina, kot tudi ne na farmakokinetiko sočasno apliciranega tkivnega aktivatorja plazminogena (t-PA).
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).
Inhalacijski iloprost (ali placebo) je bil dodan bolnikovemu takratnemu zdravljenju, ki je lahko vključevalo kombinacijo antikoagulantov, vazodilatatorjev (npr. zaviralci kalcijevih kanalčkov), diuretikov, kisika in digitalisa, ne pa tudi PGI2 (prostaciklina ali njegovih analogov).
Although, clinical studies have not been conducted, in vitro studies investigating the inhibitory potential of iloprost on the activity of cytochrome P450 enzymes revealed that no relevant inhibition of drug metabolism via these enzymes by iloprost is to be expected.
Čeprav kliničnih študij niso opravljali, so študije in vitro, v katerih so proučevali zaviralne lastnosti iloprosta na delovanje encimov citokroma P450, pokazale, da zaradi iloprosta ni pričakovati pomembnejšega zaviralnega učinka teh encimov na presnovo zdravil.
The most serious adverse reactions were hypotension, bleeding events, and bronchospasm.
Najresnejši neželeni učinki so bili hipotenzija, krvavitve in bronhospazem.
No disturbance of post-natal development and reproductive performance was seen in animals exposed during lactation.
Motenj postnatalnega razvoja in sposobnosti razmnoževanja pri živalih, ki so bile učinkovini izpostavljene med dojenjem, niso opazili.
• talk to your doctor
• se posvetujte z zdravnikom.
The ready-to-use Ventavis nebuliser solution is administered with a suitable inhalation device (nebuliser) (see below and section 6.6).
Za uporabo pripravljeno zdravilo Ventavis inhalacijska raztopina za nebulator se uporablja z ustreznim pripomočkom za inhaliranje (nebulatorjem) (glejte spodaj in poglavje 6.6).
• The other ingredients are trometamol, ethanol, sodium chloride, hydrochloric acid for pH adjustment, and water for injections.
• Druge sestavine so trometamol, etanol, natrijev klorid, klorovodikova kislina za uravnavanje vrednosti pH in voda za injekcije.
Within 30 minutes to 2 hours after the end of inhalation, iloprost is not detectable in the central compartment (limit of quantification 25 picogram/ml).
V 30 minutah do 2 urah po končani inhalaciji iloprost v osrednjem prostoru ni več zaznaven (meja kvantifikacije:
In addition to local effects resulting from administration of iloprost by inhalation such as cough, adverse reactions with iloprost are related to the pharmacological properties of prostacyclins.
Poleg lokalnih učinkov npr. kašelj, ki so posledica inhaliranega iloprosta, so neželeni učinki iloprosta povezani s farmakološkimi lastnostmi prostaciklinov.
Ventavis inhibits unwanted blocking or narrowing of blood vessels and allows more blood to flow through the vessels.
Zdravilo Ventavis preprečuje nastanek neželene zapore ali zoženje krvnih žil in omogoča večji pretok krvi skozi žile.
It is not known whether iloprost/metabolites are excreted in human breast milk.
Ni znano, ali se iloprost/presnovki izločajo v materino mleko.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
• Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve redno posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
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 pri uporabi drugih nebulatorjev, ki dajejo raztopini iloprosta drugačne pršilne lastnosti, nista dokazani.
− Pulmonary hypertension due to venous occlusive disease.
- pljučna hipertenzija zaradi venske okluzivne bolezni
• Medicines used to treat high blood pressure or heart disease, such as beta blockers, nitro-vasodilators,
• zdravila za zdravljenje visokega krvnega tlaka ali bolezni srca, kot so antagonisti adrenergičnih receptorjev beta,
Only expected pharmacological effects like hypotension, reddening of skin, dyspnoea, increased intestinal motility were observed.
Opazili so le pričakovane farmakološke učinke, kot so hipotenzija, pordelost kože, dispneja in povečana črevesna peristaltika.
In case of interruption of Ventavis therapy, the risk of rebound effect is not formally excluded.
V primeru prekinitve zdravljenja z zdravilom Ventavis se tveganja za pojav sekundarnih učinkov ne more izključiti.
• if you have a heart problem, such as poor blood flow to the heart muscles (severe coronary heart disease or unstable angina).
• če imate težave s srcem, kot so slaba prekrvitev srčne mišice (huda koronarna srčna bolezen ali nestabilna angina pektoris).
Ventavis inhalation might entail the risk of inducing bronchospasm, especially in patients with bronchial hyperactivity (see section 4.8).
Bolniki z boleznimi dihal Zdravilo Ventavis lahko povzroči tveganje za pojav bronhospazma, predvsem pri bolnikih z bronhialno hiperaktivnostjo (glejte poglavje 4.8).
Follow carefully the instructions that come with the nebuliser especially the instructions on hygiene and cleaning of the nebuliser.
Natančno upoštevajte navodila, priložena nebulatorju, predvsem navodila za vzdrževanje in čiščenje nebulatorja.
Physicians should be alerted to the presence of concomitant conditions or medicinal products that might increase the risk of hypotension and syncope (see section 4.5).
Zdravniki morajo biti pozorni na prisotnost sočasnih bolezni ali sočasno jemanje zdravil, ki lahko povečajo tveganje za pojav hipotenzije in sinkope (glejte poglavje 4.5).
What Ventavis is and what it is used for What you need to know before you use Ventavis How to use Ventavis
Kaj je zdravilo Ventavis in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Ventavis Kako uporabljati zdravilo Ventavis
• widening of the blood vessels (vasodilatation).
• razširjene krvne žile (vazodilatacija).
• if your pulmonary hypertension is due to a blocked or narrowed vein (venous occlusive disease).
• če je pri vas pljučna hipertenzija posledica zaprte ali zožene vene (venska okluzivna bolezen).
The baseline 6-minute walk test values reflected a moderate exercise limitation: in the iloprost group the mean was 332 metres (median value: 340 metres) and in the placebo group the mean was 315 metres (median value: 321 metres).
minutnega testa hoje so pokazale zmerno omejitev telesne dejavnosti: v skupini, ki je prejemala iloprost, je bilo povprečje 332 metrov (mediana vrednost: 340 metrov), medtem, ko je bilo v skupini, ki je prejemala placebo, povprečje 315 metrov (mediana vrednost: 321 metrov).
The active substance of Ventavis is iloprost.
Učinkovina zdravila Ventavis je iloprost.
• Swelling, mainly of the ankles and legs, due to fluid retention (peripheral oedema) is a very common symptom of the illness itself but can also occur during treatment with Ventavis.
Drugi možni učinki • otekanje, predvsem gležnjev in nog, zaradi zastajanja tekočine (periferni edem) je zelo pogost simptom bolezni same, vendar se lahko pojavi tudi med zdravljenjem z zdravilom Ventavis.
• Inhibition of platelet aggregation, platelet adhesion and release reaction
• zaviranje agregacije in adhezije trombocitov ter reakcij sproščanja,
Your doctor will consider changing your treatment.
Zdravnik se bo morda odločil za spremembo zdravljenja.
Contents of the pack and other information What Ventavis contains:
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Ventavis
Other possible effects
Možni neželeni učinki
The measured MMAD of the aerosol droplets was 2.6 micrometres.
Izmerjeni MMAD kapljic aerosola je bil 2,6 mikrometra.
• Bleeding events (mostly nosebleed (epistaxis) and coughing up blood (haemoptysis)) may very commonly occur, especially if you are also taking blood-thinning medicines (anticoagulants).
• Zelo pogosto se lahko pojavijo krvavitve (večinoma krvavitve iz nosu (epistaksa) in izkašljevanje krvi iz dihal (hemoptiza)), predvsem če sočasno jemljete tudi zdravila za redčenje krvi (antikoagulante).
One inhalation session with Breelib will usually last about 3 minutes.
Posamezna inhalacija z nebulatorjem Breelib običajno traja 3 minute.
No clinical trial data are available comparing directly in intra-patient observations the acute haemodynamic response after intravenous to that after inhaled iloprost.
Ni podatkov o kliničnih preskušanjih, v katerih bi pri bolnikih neposredno primerjali akutni hemodinamični odziv po intravenski in inhalacijski uporabi iloprosta.
The mean clearance of iloprost is estimated to be 10 ml/minute/kg.
Ocenjeni povprečni očistek iloprosta je približno 10 ml/min/kg.
Excipients: trometamol, ethanol 96%, sodium chloride, hydrochloric acid (for pH adjustment), water for injections.
trometamol, etanol 96 %, natrijev klorid, klorovodikova kislina (za uravnavanje vrednosti pH), voda za injekcije.
One inhalation session with Venta-Neb will usually last about 4 to 10 minutes depending on the prescribed dose.
Posamezna inhalacija z nebulatorjem Venta-Neb traja običajno 4 do 10 minut, odvisno od predpisanega odmerka.
4.2 Posology and method of administration Drug product
4.2 Odmerjanje in način uporabe Zdravilo
− Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension.
- prirojene ali pridobljene okvare zaklopk s klinično pomembno motnjo v delovanju srca, ki ni v povezavi s pljučno hipertenzijo
Fatal cases included cerebral and intracranial haemorrhage.
Med smrtnimi primeri so bile tudi smrti zaradi cerebralne in intrakranialne krvavitve.
• mouth and tongue irritation including pain
• neprijeten občutek v ustih in jeziku, tudi bolečine
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.
Presnovki se iz plazme in seča izločajo v dveh fazah, za kateri sta izračunana razpolovna časa približno 2 in 5 ur
Ventavis10 microgram/ml is available in the following packs:
Zdravilo Ventavis 10 mikrogramov/ml je na voljo v naslednjih pakiranjih:
2.5 mcg red red
2,5 mikrogramov rdeč rdeč
For administration with the Breelib or the I-Neb.
Za uporabo z nebulatorjem Breelib ali I-Neb.
• Inhaling Ventavis might trigger breathing difficulties (see section 4), especially in patients with bronchospasm (sudden constriction of the muscles in the walls of the small airways) and wheezing.
• Vdihavanje zdravila Ventavis lahko povzroči težave z dihanjem (glejte poglavje 4), predvsem pri bolnikih, ki imajo bronhospazem (nenaden krč mišic v steni majhnih dihalnih poti) in so zasopli.
No disturbance of postnatal development and reproductive performance was seen in the offspring that were raised, indicating that the observed retardation in rats was compensated during the postnatal development.
Pri mladičih niso opazili motenj v postnatalnem razvoju in sposobnosti razmnoževanja, kar kaže, da je ta zastoj v rasti pri podganah nadomeščen v postnatalnem razvoju.
In addition, instructions for hygiene and cleaning of the nebulisers provided by the device manufacturers should be followed carefully.
Dodatno je treba skrbno upoštevati tudi navodila za vzdrževanje in čiščenje nebulatorja, ki so priložena nebulatorju.
Contact of Ventavis with skin or swallowing Ventavis
Stik zdravila Ventavis s kožo ali zaužitje zdravila Ventavis
Frequently observed symptoms following overdose are dizziness, headache, flushing, nausea, jaw pain or back pain.
Pogosto opaženi simptomi po prevelikem odmerjanju so omotica, glavobol, pordevanje, navzea,bolečine v čeljusti ali bolečine v hrbtu.
• For the inhalation you should use a mouthpiece to prevent Ventavis coming into contact with your skin.
• Pri vdihavanju uporabite ustnik, da preprečite stik zdravila Ventavis s kožo.
For further details please refer to the instruction manual of the nebuliser device or ask your doctor.
Za podrobnosti glejte navodilo za uporabo nebulatorja ali se posvetujte z zdravnikom.