natgillin/translations-raw huggingface dataset:
Adempas can be taken alone or together with certain other medicines used to treat PAH.
Zdravilo Adempas se lahko jemlje samo ali skupaj z določenimi drugimi zdravili, ki se uporabljajo za zdravljenje PAH.
In case of overdose, standard supportive measures should be adopted as required.
V primeru prevelikega odmerjanja je treba uvesti ustrezne standardne podporne ukrepe.
65 years or older
Bolniki, stari 65 let ali več
Patients with mild and moderate renal impairment were included in the pivotal studies.
Bolniki z blago in zmerno ledvično okvaro so bili vključeni v ključne študije.
Do not stop taking this medicine without talking to your doctor first, because this medicine prevents the progression of the disease.
Ne prenehajte jemati tega zdravila brez predhodnega posveta z zdravnikom, saj to zdravilo preprečuje napredovanje bolezni.
During the first weeks of treatment your doctor will need to measure your blood pressure at regular intervals.
V prvih tednih zdravljenja vam bo zdravnik moral meriti krvni tlak v rednih intervalih.
If you are older than 65 years, you have an increased risk of developing low blood pressure.
Če ste starejši od 65 let, imate povečano tveganje za nizek krvni tlak.
The volume of distribution is moderate with volume of distribution at steady state being approximately 30 L.
Volumen porazdelitve je zmeren; volumen porazdelitve v stanju dinamičnega ravnovesja je približno 30 l.
Based on this study and as riociguat is not an inducer of any of the relevant metabolic enzymes, also no pharmacokinetic interaction is expected with other hormonal contraceptives.
Glede na to študijo in ker riociguat ni induktor katerega koli od pomembnih encimov presnove, tudi farmakokinetičnih interakcij z drugimi hormonskimi kontraceptivi ni pričakovati.
If you miss a dose, continue with the next dose as planned.
Če ste pozabili vzeti odmerek, nadaljujte z naslednjim odmerkom, kot je načrtovano.
Your doctor will regularly monitor you.
Zdravnik bo redno spremljal zdravljenje.
The European Medicines Agency has deferred the obligation to submit the results of studies with Adempas in one or more subsets of the paediatric population in the treatment of pulmonary hypertension.
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Adempas za eno ali več podskupin pediatrične populacije pri zdravljenju pljučne hipertenzije.
Effects of other substances on riociguat
Vpliv drugih učinkovin na riociguat
Because the heart must work harder than normal, people with pulmonary hypertension feel tired, dizzy and short of breath.
Ker mora srce delati močneje kot običajno, se bolniki s pljučno hipertenzijo počutijo utrujene, omotične in zasople.
In case treatment has to be interrupted for 3 days or more, treatment should be restarted with 1 mg three times daily for 2 weeks, and continued with the dose titration regimen as described above.
Če je treba zdravljenje prekiniti za 3 dni ali več, je treba zdravljenje ponovno začeti z odmerkom 1 mg trikrat na dan 2 tedna, nato pa zdravljenje nadaljevati s titriranjem odmerka, kot je opisano zgoraj.
If your treatment has to be stopped for 3 days or more, please tell your doctor before restarting your treatment.
Če morate zdravljenje prekiniti za 3 dni ali več, obvestite zdravnika, preden začnete ponovno jemati zdravilo.
Riociguat pharmacokinetics are linear from 0.5 to 2.5 mg. Inter-individual variability (CV) of riociguat exposure (AUC) across all doses is approximately 60%.
Farmakokinetika riociguata je linearna od 0,5 do 2,5 mg. Interindividualna variabilnost (CV) izpostavljenosti riociguatu (AUC) je za vse odmerke približno 60 %.
With increased doses, over additive effects on systemic blood pressure were observed in some cases.
Pri povečevanju odmerkov so v nekaterih primerih opazili več kot aditivne učinke na sistemski krvni tlak.
Data from animals indicate that riociguat is excreted into milk.
Podatki na živalih kažejo, da se riociguat izloča v mleko.
Patients with ALT > 3 x ULN and bilirubin > 2 x ULN were not studied (see section 4.4).
Bolnikov z ALT > 3 x ULN in bilirubinom > 2 x ULN niso preučevali (glejte poglavje 4.4).
Riociguat is rapidly absorbed with maximum concentrations (Cmax) appearing 1-1.5 hours after tablet intake.
Riociguat se hitro absorbira in doseže največje koncentracije (Cmax) 1 - 1,5 ure po zaužitju tablete.
In juvenile rats, the changes consisted of thickening of trabecular bone and of hyperostosis and remodeling of metaphyseal and diaphyseal bone, whereas in adolescent rats an overall increase of bone mass was observed.
Pri mladih podganah so spremembe predstavljali zadebelitev trabekularne kosti in hiperostoza ter preoblikovanje metafiz in diafiz, medtem ko so pri adolescentnih podganah opazili celokupno povečanje kostne mase.
If any of these applies to you, talk to your doctor first and do not take Adempas.
Če kar koli od navedenega velja za vas, se najprej posvetujte z zdravnikom in ne jemljite zdravila Adempas.
• persistent or recurrent CTEPH after surgical treatment, to improve exercise capacity (see section 5.1).
• perzistentno ali ponovno CTEPH po kirurškem zdravljenju, za izboljšanje telesne zmogljivosti (glejte poglavje 5.1).
Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake "EXP".
Your dose may need to be adjusted.
Vaš odmerek bo morda treba prilagoditi.
Concomitant use with CYP3A4 inducers
Sočasna uporaba z induktorji CYP3A4
Individual dose titration at treatment initiation allows adjustment of the dose to the patient´s needs.
Titriranje odmerka na začetku zdravljenja omogoča prilagoditev le-tega bolnikovim potrebam.
Do not take Adempas during pregnancy.
Zdravila Adempas ne smete jemati med nosečnostjo.
If this happens, contact your doctor immediately as you may need urgent medical treatment.
V tem primeru takoj obvestite zdravnika, saj morda potrebujete takojšnjo zdravniško pomoč.
It works by widening the pulmonary arteries (the blood vessels that connect the heart to the lungs), making it easier for the heart to pump blood through the lungs.
Deluje tako, da razširi pljučne arterije (krvne žile, ki povezujejo srce s pljuči) in zato srce lažje črpa kri skozi pljuča.
Tél : + 33 (0) 1 80 46 40 40
MSD FRANCE Tél : + 33 (0) 1 80 46 40 40
If there is a chance you could become pregnant, use reliable forms of contraception while you are taking these tablets.
Če obstaja možnost da zanosite, morate med jemanjem teh tablet uporabljati zanesljive kontracepcijske metode.
The risk of serious and fatal respiratory tract bleeding may be further increased under treatment with riociguat, especially in the presence of risk factors, such as recent episodes of serious haemoptysis including those managed by bronchial arterial embolisation.
Tveganje za resne in smrtne krvavitve v dihalih se lahko med zdravljenjem z riociguatom še poveča, predvsem ob prisotnosti dejavnikov tveganja, kot so nedavne resne hemoptize, vključno s tistimi po embolizaciji bronhialnih arterij.
Special considerations for patients with kidney or liver problems You should tell your doctor if you have kidney or liver problems.
Posebna navodila za bolnike, ki imajo težave z ledvicami ali jetri Obvestite zdravnika, če imate težave z ledvicami ali jetri.
Riociguat also directly stimulates sGC independently of NO.
Riociguat spodbuja sGC tudi neposredno, neodvisno od NO.
Your doctor will monitor your health status and should consider a reduced starting dose for Adempas.
Zdravnik bo spremljal vaše zdravstveno stanje in razmislil o zmanjšanju začetnega odmerka zdravila Adempas.
95% CI, [p-value]
95 % CI, [vrednost p]
The tablets should be taken 3 times a day, approximately 6 to 8 hours apart.
Tablete se jemlje trikrat na dan, približno vsakih 6 do 8 ur.
The safety profile observed in HIV patients taking a single dose of 0.5 mg riociguat together with different combinations of HIV drugs used in HAART was generally comparable to other patient populations.
Varnostni profil, ki so ga opazili pri bolnikih, okuženih z virusom HIV, ki so jemali enkratni odmerek 0,5 mg riociguata hkrati z različnimi kombinacijami zdravil proti virusu HIV, uporabljenih v HAART, je bil na splošno primerljiv z varnostnim profilom pri drugih populacijah bolnikov.
An open-label extension study (CHEST-2) included 237 patients who had completed CHEST-1.
V odprto podaljšanje študije (CHEST-2) je bilo vključenih 237 bolnikov, ki so zaključili študijo CHEST-1.
In cigarette smokers riociguat exposure is reduced by 50-60% (see section 5.2).
Pri kadilcih cigaret se izpostavljenost riociguatu zmanjša za 50 - 60 % (glejte poglavje 5.2).
Inadvertent overdosing with total daily doses of 9 to 25 mg riociguat between 2 to 32 days was reported.
Poročali so o nenamernih prevelikih dnevnih odmerkih od 9 do 25 mg riociguata med 2. do 32. dnem.
Patients should be aware of how they react to this medicinal product, before driving or using machines.
Bolniki morajo pred vožnjo ali upravljanjem strojev vedeti, kako se odzivajo na to zdravilo.
Tablets should be taken three times daily approximately 6 to 8 hours apart (see section 5.2).
Tablete je treba vzeti trikrat na dan, približno vsakih 6 do 8 ur (glejte poglavje 5.2).
In growing, juvenile and adolescent rats, effects on bone formation were seen.
Pri rastočih, mladih in adolescentnih podganah so opazili učinke na rast in razvoj kosti.
Current smokers should be advised to stop smoking due to a risk of a lower response.
Kadilcem je treba svetovati, da prenehajo s kajenjem, ker obstaja tveganje za slabši odziv na zdravljenje.
- if you have low blood pressure (systolic blood pressure less than 95 mmHg) before starting first treatment with this medicine.
- če imate nizek krvni tlak (sistolični krvni tlak manj kot 95 mm Hg) pred začetkom prvega zdravljenja s tem zdravilom).
Blood pressure should be monitored and dose reduction of riociguat be considered.
Spremljati je treba krvni tlak in razmisliti o zmanjšanju odmerka riociguata.
Adverse reactions were similar to those seen at lower doses (see section 4.8).
Neželeni učinki so bili podobni tistim, ki so jih opazili pri manjših odmerkih (glejte poglavje 4.8).
What Adempas is and what it is used for 2.
Kaj je zdravilo Adempas in za kaj ga uporabljamo 2.
Highly active antiretroviral therapy (HAART)
Visokoaktivno protiretrovirusno zdravljenje (HAART - highly active antiretroviral therapy)
- if you are allergic to riociguat or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na riociguat ali katero koli sestavino tega zdravila (navedeno v poglavju 6), - če ste noseči.
What you need to know before you take Adempas 3.
Kaj morate vedeti, preden boste vzeli zdravilo Adempas 3.
Adempas can be used for patients with CTEPH who cannot be operated on, or after surgery for patients in whom increased blood pressure in the lungs remains or returns.
Zdravilo Adempas se lahko uporablja pri bolnikih s CTEPH, ki jih ni mogoče operirati, ali pri bolnikih, ki so bili operirani, a je zvišan krvni tlak v pljučih ostal visok ali pa se je ponovno zvišal.
Efficacy in patients with CTEPH
Učinkovitost pri bolnikih s CTEPH
A careful monitoring of patients taking anticoagulants according to common medical practice is recommended.
Pri bolnikih, ki jemljejo antikoagulante, se priporoča skrbno spremljanje v skladu z običajno klinično prakso.
In addition, ritonavir showed inhibition of P-gp.
Poleg tega je ritonavir zaviral P-gp.
If you are 65 years or older your doctor will take extra care in adjusting your dose of Adempas, because you may be at greater risk of low blood pressure.
Če ste stari 65 let ali več, vam bo zdravnik posebno previdno določil odmerek zdravila Adempas, saj pri vas obstaja večje tveganje za nizek krvni tlak.
The safety of Adempas has been evaluated in phase III studies of 681 patients with CTEPH and PAH receiving at least one dose of riociguat (see section 5.1).
Varnost zdravila Adempas so ocenjevali v študijah faze III, v katere je bilo vključenih 681 bolnikov s CTEPH in PAH, ki so prejeli vsaj en odmerek riociguata (glejte poglavje 5.1).
NAME OF THE MARKETING AUTHORISATION HOLDER Bayer (Logo)
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Bayer (logotip)
Developmental toxicity studies in rats and rabbits have shown reproductive toxicity of riociguat.
Študije razvojne toksičnosti pri podganah in kuncih so pokazale toksičnost riociguata na sposobnost razmnoževanja.
Intra-cellular cGMP plays an important role in regulating processes that influence vascular tone, proliferation, fibrosis, and inflammation.
Znotrajcelični cGMP ima pomembno vlogo pri uravnavanju žilnega tonusa, proliferacije, fibroze in vnetja.
Dizziness has been reported and may affect the ability to drive and use machines (see section 4.8).
Poročali so o omotici, ki lahko vpliva na sposobnost vožnje in upravljanja s stroji (glejte poglavje 4.8).
Results were consistent in the main sub-groups evaluated (ITT analysis, see table 2).
Izsledki so bili skladni v vseh glavnih ovrednotenih podskupinah (analiza glede na namero zdravljenja (ITT - intention-to-treat, glejte preglednico 2).
It may cause side effects such as dizziness.
Zdravilo lahko povzroči neželene učinke, kot je omotičnost.
These findings were in accordance with improvements in additional haemodynamic parameters.
Ti izsledki so bili v skladu z izboljšanji drugih hemodinamskih parametrov.
Hospitalisations due to PH Decrease in 6MWD due to PH Persistent worsening of Functional Class due to PH
bolniki s kakršnim koli kliničnim poslabšanjem smrt hospitalizacija zaradi PH skrajšanje 6MWD zaradi PH vztrajno poslabševanje funkcijskega razreda zaradi PH uvedba novega zdravljenja PH
The use of riociguat in other forms of PAH not studied is not recommended (see section 5.1).
Uporabe riociguata se ne priporoča pri drugih, neraziskanih oblikah PAH (glejte poglavje 5.1).
Treatment should only be started and monitored by a doctor experienced in the treatment of CTEPH or PAH.
Zdravljenje mora uvesti in nadzirati zdravnik, ki ima izkušnje z zdravljenjem CTEPH ali PAH.
Your doctor will decide with you if you either should stop breast-feeding or stop treatment with Adempas.
Zdravnik se bo skupaj z vami odločil, ali boste prenehali dojiti ali pa se boste prenehali zdraviti z zdravilom Adempas.
All patients were WHO Functional Class III and 82% received background therapy with an endothelin receptor antagonist (ERA).
Vsi bolniki so spadali v III. funkcijski razred po klasifikaciji SZO in 82 % jih je prejemalo osnovno zdravljenje z antagonisti endotelinskih receptorjev (ERA - endothelin receptor antagonist).
If you have taken more tablets than you should and experience any side effects (see section 4), please contact your doctor.
Če ste vzeli večji odmerek zdravila Adempas, kot bi smeli Če ste vzeli več tablet, kot bi smeli, in imate kakršne koli neželene učinke (glejte poglavje 4), se posvetujte z zdravnikom.
Riociguat has vasodilatory properties which may result in lowering of blood pressure.
Riociguat deluje vazodilatacijsko, kar ima lahko za posledico znižanje krvnega tlaka.
Please tell your doctor if you smoke or if you stop smoking during treatment.
Zdravnika obvestite, če kadite ali če med zdravljenjem prenehate kaditi.
You will receive Adempas only for special types of pulmonary arterial hypertension (PAH), see section 1.
Zdravilo Adempas boste prejeli le za določeno obliko pljučne arterijske hipertenzije (PAH), glejte poglavje 1.
An open-label extension study (PATENT-2) included 396 patients who had completed PATENT-1 at the cut-off-date.
V odprto podaljšanje študije (PATENT-2) je bilo vključenih 396 bolnikov, ki so zaključili študijo PATENT-1 na presečni dan zbiranja podatkov.
Due to the potential for serious adverse reactions in breast-fed infants Adempas should not be used during breast-feeding.
Zaradi možnih resnih neželenih učinkov pri dojenčkih, se zdravila Adempas ne sme uporabljati med dojenjem.
you have any symptoms of low blood pressure (hypotension) such as dizziness, lightheadedness, or fainting or if you are taking medicines to lower your blood pressure or medicines that cause an increase in urination or if you have problems with your heart or circulation.
- če imate simptome nizkega krvnega tlaka (hipotenzija), kot so omotica, vrtoglavica ali omedlevica, ali če jemljete zdravila za zniževanje krvnega tlaka ali zdravila, ki povečajo pogostnost uriniranja, ali če imate težave s srcem ali krvnim obtokom.
If you have difficulty swallowing the whole tablet, talk to your doctor about other ways to take Adempas.
Če ne morete požirati celih tablet, se z zdravnikom pogovorite o drugih načinih jemanja zdravila Adempas.
The maximum total daily dose is 7.5 mg i.e., 2.5 mg 3 times daily.
Največji dnevni odmerek je 7,5 mg, tj. 2,5 mg trikrat na dan.
Concomitant treatment of riociguat and warfarin did not alter prothrombin time induced by the anticoagulant.
Sočasno zdravljenje z riociguatom in varfarinom ni vplivalo na spremembo protrombinskega časa, doseženega z antikoagulantom.
- if you have increased pressure in your pulmonary circulation associated with scarring of the lungs, of unknown cause (idiopathic pulmonary pneumonia).
- če imate zvišan tlak v pljučnem krvnem obtoku, povezan z brazgotinjenjem pljuč neznanega vzroka (idiopatsko pljučnico).
In chronic thromboembolic pulmonary hypertension, pulmonary endarterectomy is the treatment of choice as it is a potentially curative option.
Pri kronični trombembolični pljučni hipertenziji je pljučna endarteriektomija metoda izbora za zdravljenje, saj je potencialno kurativna.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
Therefore, patients are advised to stop smoking (see section 4.2).
Zato je treba bolnikom svetovati, da prenehajo kaditi (glejte poglavje 4.2).
Cobicistat, ritonavir, atazanavir and darunavir are additionally classified as CYP3A inhibitors.
Kobicistat, ritonavir, atazanavir in darunavir so dodatno opredeljeni kot zaviralci CYP3A.
Effects observed in repeat-dose toxicity studies were mainly due to the exaggerated pharmacodynamic activity of riociguat (haemodynamic and smooth muscle relaxing effects).
Učinki, ki so jih opazili v študijah ponavljajočih odmerkov, so bili posledica predvsem poudarjene farmakodinamične aktivnosti riociguata (hemodinamski učinki in sprostitev gladkih mišic).
Corresponding values for the main metabolite were higher in subjects with renal impairment compared to healthy subjects.
Ustrezne vrednosti za glavni presnovek so bile večje pri osebah z ledvično okvaro v primerjavi z zdravimi osebami.
Should signs of pulmonary oedema occur, the possibility of associated PVOD should be considered and treatment with riociguat should be discontinued.
Če se pojavijo znaki pljučnega edema, je treba pomisliti na možnost pridružene pljučne venookluzivne bolezni in zdravljenje z riociguatom prekiniti.
What you need to know before you take Adempas
Kaj morate vedeti, preden boste vzeli zdravilo Adempas
What Adempas is and what it is used for
Kaj je zdravilo Adempas in za kaj ga uporabljamo
These findings were in accordance with improvements in additional haemodynamic parameters (see table 5).
Ti izsledki so bili v skladu z izboljšanjem drugih hemodinamskih parametrov (glejte preglednico 5).
In elderly patients (65 years or older) there is a higher risk of hypotension and therefore particular care should be exercised during individual dose titration (see section 5.2).
Pri starejših bolnikih (starih 65 let ali več) obstaja večje tveganje za hipotenzijo, zato je pri titriranju odmerka potrebna posebna previdnost (glejte poglavje 5.2).
Riociguat must not be used in patients with a systolic blood pressure below 95 mmHg (see section 4.3).
Riociguata se ne sme uporabljati pri bolnikih s sistoličnim krvnim tlakom nižjim od 95 mm Hg (glejte poglavje 4.3).
There was no evidence of a favourable clinical effect of the combination in the population studied.
Koristni klinični učinki omenjene kombinacije zdravil v preučevani populaciji niso bili ugotovljeni.
Adempas is available in different strengths and by checking your blood pressure regularly at the beginning of your treatment, your doctor will ensure that you are taking the appropriate dose.
Zdravilo Adempas je na voljo v različnih jakostih, zato bo zdravnik z rednim merjenjem vašega krvnega tlaka na začetku zdravljenja določil ustrezen odmerek.
If you forget to take Adempas
Če ste pozabili vzeti zdravilo Adempas
Adempas is a film-coated tablet:
Zdravilo Adempas je filmsko obložena tableta:
• acute bleeding from the lungs (pulmonary haemorrhage) may result in coughing up blood, cases with fatal outcomes were observed (uncommon side effect, may affect up to 1 in 100 people).
• akutna krvavitev v pljučih (pulmonalna krvavitev) lahko povzroči izkašljevanje krvi, opazili so primere s smrtnim izidom (občasni neželeni učinek, ki se lahko pojavi pri največ 1 od
Intake with food reduced riociguat AUC slightly, Cmax was reduced by 35%.
Jemanje s hrano blago zmanjša AUC riociguata; Cmax se je zmanjšal za 35 %.
• In patients on stable doses of Adempas, the initiation of strong multi pathway CYP and P-gp/BCRP inhibitors is not recommended as no dosage recommendation can be given due to limited data.
• Pri bolnikih na stabilnih odmerkih zdravila Adempas se ne priporoča uvedba močnih zaviralcev več presnovnih poti CYP in P-gp/BCRP, ker zaradi omejenih podatkov ni mogoče dati nobenega priporočila.
If you have been told by a doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte z zdravnikom.
Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD).
Pljučni vazodilatatorji lahko močno poslabšajo kardiovaskularno stanje bolnikov s pljučno venookluzivno boleznijo (PVOD - pulmonary veno-occlusive disease).
In pulmonary hypertension patients there is increased likelihood for respiratory tract bleeding, particularly among patients receiving anticoagulation therapy.
Pri bolnikih s pljučno hipertenzijo je večja verjetnost krvavitev v dihalih, predvsem pri bolnikih, ki se zdravijo z antikoagulanti.
Therefore, drug-drug interactions by inhibition of CYP1A1 could result in increased riociguat exposure, especially in smokers (see section 5.2).
Zato lahko medsebojno delovanje zdravil, ki zavirajo CYP1A1 poveča izpostavljenost riociguatu, predvsem pri kadilcih (glejte poglavje 5.1).
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium free”.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni »brez natrija«.
Do not take Adempas: - if you are taking certain medicines called PDE5 inhibitors (e.g. sildenafil, tadalafil, vardenafil).
Ne jemljite zdravila Adempas: - če jemljete določena zdravila, imenovana zaviralci PDE-5 (npr. sildenafil, tadalafil, vardenafil).
Strong CYP1A1 inhibitors should be used with caution (see section 4.4).
Močne zaviralce CYP1A1 je treba uporabljati previdno (glejte poglavje 4.4).
For the transition from PDE5 inhibitors to riociguat, median treatment-free time for sildenafil was 1 day and for tadalafil 3 days.
Ob prehodu z zaviralcev PDE5 na riociguat je bil mediani čas brez zdravljenja 1 dan za sildenafil in 3 dni za tadalafil.
The recommended starting dose is 1 mg three times daily for 2 weeks.
Priporočeni začetni odmerek je 1 mg trikrat na dan 2 tedna.