natgillin/translations-raw huggingface dataset:
For more information about using Lynparza, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Lynparza glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
An overview of Lynparza and why it is authorised in the EU
Pregled zdravila Lynparza in zakaj je odobreno v EU
Why is Lynparza authorised in the EU?
Zakaj je bilo zdravilo Lynparza odobreno v EU?
The company that markets Lynparza will carry out studies to further confirm the benefit, including long-term benefit, of the medicine in patients with ovarian cancer.
Podjetje, ki trži zdravilo Lynparza, bo izvedlo študije za nadaljnjo potrditev koristi, vključno z dolgoročno koristjo zdravila pri raku jajčnikov.
Lynparza can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the use of cancer medicines.
Predpisovanje in izdaja zdravila Lynparza je le na recept, zdravljenje pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
Therefore, when PARP proteins are blocked, the damaged DNA in cancer cells cannot be repaired, and, as a result, the cancer cells die.
Z zaviranjem beljakovin PARP se poškodovana DNK v rakavih celicah ne more popraviti, zato rakave celice odmrejo.
The active substance in Lynparza, olaparib, blocks the action of enzymes called human poly (ADP ribose) polymerase (PARP), which help to repair damaged DNA in cells (both in normal and in cancer cells) during cell division.
Učinkovina v zdravilu Lynparza, olaparib, zavira delovanje encimov, imenovanih humane poli (ADPriboza) polimeraze (PARP), ki v celicah (normalnih in rakavih) pomagajo popravljati poškodovano DNK.
Lynparza contains the active substance olaparib.
Zdravilo Lynparza vsebuje učinkovino olaparib.
What are the risks associated with Lynparza?
Kakšna tveganja so povezana z zdravilom Lynparza?
• treatment of breast cancer which is HER2-negative and that has spread beyond the original site in patients with mutations in BRCA1 or BRCA2 genes who have been treated with certain breast cancer medicines (unless these medicines were not suitable).
• zdravljenje raka dojk, ki je HER2-negativen in se je razširil zunaj prvotne lokacije pri bolnikih z mutacijami v genih BRCA1 ali BRCA2 , ki so bili zdravljeni z določenimi zdravili za zdravljenje raka (razen če ta zdravila niso bila primerna).
What is Lynparza and what is it used for?
Kaj je zdravilo Lynparza in za kaj se uporablja?
Lynparza was effective in a study involving 302 patients with HER2-negative breast cancer with BRCA1/2 mutations whose cancer had spread.
Zdravilo Lynparza je bilo učinkovito v študiji, ki je vključevala 302 bolnika s HER2-negativnim rakom dojke z mutacijami genov BRCA1/2, pri katerih se je rak razširil.
• In a third study involving 391 patients with advanced cancer who had BRCA1/2 mutations, the disease had not got worse in around 74% of patients who took Lynparza for 2 years compared with 35% of patients on placebo.
• V tretji študiji, v katero je bilo vključenih 391 bolnikov z napredovalim rakom z mutacijami genov BRCA1/2, se bolezen ni poslabšala pri približno 74 % bolnikov, ki so jemali zdravilo Lynparza dve leti, v primerjavi z 35 % bolnikov, ki so prejemali placebo.
Studies show that Lynparza increases the time patients live without their disease getting worse after treatment with platinum-based chemotherapy has reduced or cleared the cancer:
Študije so pokazale, da zdravilo Lynparza podaljša čas, ki ga bolniki preživijo brez poslabšanja bolezni po zmanjšanju ali odstranitvi raka s kemoterapijo na osnovi platine.
− in newly diagnosed women with advanced cancer with mutations (changes) in one or both genes known as BRCA1 and BRCA2 who have been treated with platinum-based chemotherapy and in whom this treatment has reduced or cleared the cancer;
− ženskah z novo diagnosticiranim napredovalim rakom z mutacijami (spremembami) v enem ali obeh genih, znanih kot BRCA1 in BRCA2, ki so bile zdravljene s kemoterapijo na osnovi platine, zaradi česar se je rak zmanjšal ali izginil;
For the full list of side effects and restrictions with Lynparza, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Lynparza glejte navodilo za uporabo.
• continuing treatment of high-grade (fast-growing) cancers of the ovaries, fallopian tubes (which connect the ovaries to the womb) and the peritoneum (membrane lining the abdomen) in:
• nadaljevalno zdravljenje raka visoke stopnje (hitrorastočega raka) jajčnikov, jajcevodov (ki povezujejo jajčnike z maternico) in potrebušnice (mrene v trebušni votlini) pri:
In ovarian, fallopian tube or peritoneal cancers, Lynparza can also delay the next cycle of platinum chemotherapy.
Pri raku jajčnikov, jajcevodov ali potrebušnice lahko zdravilo Lynparza odloži naslednji cikel kemoterapije na osnovi platine.
− women whose cancer had come back (relapsed) after previous treatment and in whom platinum-based chemotherapy has reduced or cleared the cancer;
− ženskah, katerih rak se je po predhodnem zdravljenju ponovno pojavil in pri katerih se je s kemoterapijo na osnovi platine zmanjšal ali izginil;
Patients treated with Lynparza lived on average 7.0 months without their disease getting worse compared with 4.2 months for patients treated with the doctor's choice of another cancer medicine.
Bolniki, zdravljeni z zdravilom Lynparza, so v povprečju živeli 7,0 meseca brez poslabšanja bolezni, bolniki, zdravljeni z drugim zdravilom za zdravljenje raka po zdravnikovi presoji, pa štiri mesece.
How does Lynparza work?
Kako zdravilo Lynparza deluje?
Generally the outcome is poor for patients with ovarian, fallopian tube or peritoneal cancers and for patients with HER2-negative breast cancer with BRCA mutations whose cancer has spread.
Na splošno je izid pri bolnikih z rakom jajčnikov, jajcevodov ali potrebušnice ter pri bolnikih s HER2negativnim rakom dojke z mutacijami gena BRCA, pri katerih se je rak razširil, slab.
• In another study involving 265 patients with relapsed cancer, those who took Lynparza lived on average for 8.4 months without their disease getting worse compared with 4.8 months for patients on placebo.
• V drugi študiji, v katero je bilo vključenih 265 bolnikov s ponovljenim rakom, so tisti, ki so jemali zdravilo Lynparza, brez poslabšanja bolezni povprečno živeli 8,4 meseca, bolniki, ki so jemali placebo, pa 4,8 meseca.
How is Lynparza used?
Kako se zdravilo Lynparza uporablja?
• A study of 295 patients with relapsed cancer of the ovary, fallopian tube or peritoneum found that those receiving Lynparza lived on average for 19.1 months without their disease getting worse compared with 5.5 months for patients receiving placebo (a dummy treatment).
• V študiji z 295 bolniki s ponovljenim rakom jajčnikov, jajcevodov ali potrebušnice so ugotovili, da so bolniki, ki so prejemali zdravilo Lynparza, brez poslabšanja bolezni povprečno živeli 19,1 meseca, bolniki, ki so prejemali placebo (zdravilo brez učinkovine), pa 5,5 meseca.
Treatment may be interrupted or stopped or the dose reduced if certain side effects develop.
Če se pojavijo določeni neželeni učinki, bo morda treba začasno ali trajno prekiniti zdravljenje ali zmanjšati odmerek.
The European Commission granted a marketing authorisation valid throughout the European Union for Vimpat on 29 August 2008.
Evropska komisija je dovoljenje za promet z zdravilom Vimpat, veljavno po vsej Evropski uniji, izdala 29. avgusta 2008.
It can also be used in patients who are temporarily unable to take the tablets or syrup.
Prav tako se lahko uporablja pri bolnikih, ki začasno ne morejo jemati tablet ali sirupa.
What measures are being taken to ensure the safe and effective use of Vimpat?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vimpat?
The full EPAR for Vimpat can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Vimpat je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What is Vimpat and what is it used for?
Kaj je zdravilo Vimpat in za kaj se uporablja?
Vimpat infusion can be used to begin treatment.
Infuzija zdravila Vimpat se lahko uporablja za začetek zdravljenja.
It explains how the Agency assessed the medicine to recommend its authorisation and its conditions of use.
Pojasnjuje, kako je agencija ocenila zdravilo, na podlagi česar je priporočila njegovo odobritev in pogoje njegove uporabe.
It is not intended to provide practical advice on how to use Vimpat.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
What benefits of Vimpat have been shown in studies?
Kakšne koristi je zdravilo Vimpat izkazalo v študijah?
This is a summary of the European public assessment report (EPAR) for Vimpat.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vimpat.
What are the risks associated with Vimpat?
Kakšna tveganja so povezana z zdravilom Vimpat?
Vimpat must not be used in people who have second or third degree AV block (a type of heart rhythm disorder).
Zdravila Vimpat ne smejo uporabljati osebe, ki imajo AV blok druge ali tretje stopnje (vrsto motnje srčnega ritma).
It can be used to treat partial-onset seizures with or without secondary generalisation (where the seizure subsequently spreads to other parts of the brain).
Uporablja se lahko za zdravljenje napadov parcialnega izvora s sekundarno generalizacijo ali brez nje (ko se napad posledično razširi na druge dele možganov).
If treatment with Vimpat has to be stopped, the dose should be gradually reduced.
Če je treba zdravljenje z zdravilom Vimpat prekiniti, je treba odmerek zmanjševati postopoma.
This action may prevent abnormal electrical activity spreading through the brain, reducing the chance of an epileptic fit.
To lahko prepreči širjenje nenormalne električne dejavnosti po možganih, s čimer se zmanjša možnost pojava epileptičnega napada.
This compared with 23% of the patients taking placebo.
Ta delež je pri bolnikih, ki so jemali placebo, znašal 23 %.
The company also provided data to support dosing of Vimpat in children from 4 years of age and supportive results from studies of the safety of Vimpat in this population.
Družba je zagotovila tudi podatke v podporo odmerjanju zdravila Vimpat pri otrocih, starih štiri leta ali več, in podporne rezultate iz študij o varnosti zdravila Vimpat pri tej populaciji.
Two additional studies looked at the appropriate duration of the infusion for Vimpat solution and compared its safety with that of placebo infusions in a total of 199 patients.
V dveh dodatnih študijah so ugotavljali ustrezno trajanje infundiranja raztopine zdravila Vimpat ter primerjali njegovo varnost z infuzijami placeba pri 199 bolnikih.
Other information about Vimpat
Druge informacije o zdravilu Vimpat
In younger patients weighing less than 50 kg, the dose is based on body weight, and treatment may be started with the syrup.
Pri mlajših bolnikih s telesno maso, manjšo od 50 kg, odmerek temelji na telesni masi, zdravljenje pa se lahko začne s sirupom.
If the doctor decides that a faster effect is needed, treatment in some patients with Vimpat may be started with a higher first dose (called a loading dose).
Če zdravnik meni, da je potreben hitrejši učinek, se lahko zdravljenje z zdravilom Vimpat prične z višjim začetnim odmerkom (imenovanim polnilni odmerek).
Taking the known side effects into account, the Agency considered Vimpat's benefits to be greater than its risks and recommended that it be given marketing authorisation.
Agencija je ob upoštevanju znanih neželenih učinkov menila, da so koristi zdravila Vimpat večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vimpat have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Vimpat upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
The 600-mg dose was as effective as the 400-mg dose, but it had more side effects.
600-miligramski odmerek je bil enako učinkovit kot 400-miligramski odmerek, vendar je povzročal več neželenih učinkov.
Around 78% of Vimpat-treated and 83% of carbamazepine-treated patients did not have a seizure for 12 months.
Približno 78 % bolnikov, ki so jemali zdravilo Vimpat, in 83 % tistih, ki so jemali karbamazepin, ni imelo epileptičnega napada 12 mesecev.
For more information about treatment with Vimpat read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Vimpat preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Vimpat is an epilepsy medicine used to treat partial-onset seizures (epileptic fits starting in one specific part of the brain) in patients with epilepsy aged 4 years and older.
Vimpat je zdravilo proti epilepsiji, ki se uporablja za zdravljenje parcialnih napadov (epileptičnih napadov, ki se začnejo v določenem delu možganov) pri bolnikih z epilepsijo, starejših od 4 let.
The most common side effects with Vimpat (seen in more than 1 patient in 10) are dizziness, headache, diplopia (double vision) and nausea (feeling sick).
Najpogostejši neželeni učinki zdravila Vimpat (opaženi pri več kot 1 bolniku od 10) so omotica, glavobol, diplopija (dvojni vid) in navzeja (slabost).
The main measure of effectiveness was the proportion of patients who did not have a seizure for at least 6 months after reaching a stable dose.
Glavno merilo učinkovitosti je bil delež bolnikov, ki niso imeli epileptičnega napada vsaj šest mesecev po doseženem ustaljenem odmerku.
Why is Vimpat approved?
Zakaj je bilo zdravilo Vimpat odobreno?
This was found to be 90% in those taking Vimpat and 91% in those taking carbamazepine.
Ta delež je pri bolnikih, ki so jemali zdravilo Vimpat, znašal 90 %, pri tistih, ki so jemali karbamazepin, pa 91 %.
Vimpat was more effective than placebo (a dummy treatment) at reducing seizures in three main studies involving a total of 1,308 patients aged 16 years and above also taking other epilepsy medicines.
Zdravilo Vimpat je bilo učinkovitejše od placeba (zdravila brez zdravilne učinkovine) pri zmanjševanju števila napadov v treh glavnih študijah, v katerih je sodelovalo 1 308 bolnikov, starih 16 ali več let, ki so jemali tudi druga zdravila proti epilepsiji.
Vimpat is given on its own or combined with other medicines for epilepsy.
Zdravilo Vimpat se daje samostojno ali v kombinaciji z drugimi zdravili za zdravljenje epilepsije.
The usual starting dose in adults and older children (weighing at least 50 kg) is 50 mg twice a day which may be increased weekly to a maximum dose of 300 mg twice a day if used alone, or 200 mg twice a day if given with other epilepsy medicines.
Običajni začetni odmerek pri odraslih in starejših otrocih (s telesno maso najmanj 50 kg) je 50 mg dvakrat na dan, ki se ga lahko tedensko povečuje do največjega odmerka 300 mg dvakrat na dan, če se zdravilo uporablja samostojno, ali 200 mg dvakrat na dan, če se daje z drugimi zdravili za epilepsijo.
For practical information about using Vimpat, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Vimpat naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The European Medicines Agency decided that Vimpat, used alone or added to other epilepsy medicines, had been shown to be effective in the treatment of partial onset seizures.
Evropska agencija za zdravila je zaključila, da je zdravilo Vimpat, ki se uporabi samostojno ali kot dodatek k drugemu zdravilu za epilepsijo, dokazano učinkovito pri zdravljenju parcialnih napadov.
A fourth study involving 888 recently diagnosed patients showed that Vimpat, used on its own by mouth at a dose of 200 mg to 600 mg a day, was at least as effective as carbamazepine, another medicine for epilepsy.
Četrta študija, v katero je bilo vključenih 888 nedavno diagnosticiranih bolnikov, je pokazala, da je bilo zdravilo Vimpat, uporabljeno samostojno in vzeto peroralno v odmerku od 200 mg do 600 mg na dan, vsaj tako učinkovito kot karbamazepin, drugo zdravilo proti epilepsiji.
Lower doses should be used in patients with severely reduced kidney function or reduced liver function.
Pri bolnikih s hudo okvaro delovanja ledvic je treba uporabljati nižje odmerke.
Taking the results of the three main studies together, 34% of the patients taking Vimpat 200 mg a day and 40% of the patients taking Vimpat 400 mg a day with their existing treatment had a reduction in their seizures by at least half.
Ob upoštevanju rezultatov treh glavnih študij skupaj se je pri 34 % bolnikov, ki so poleg obstoječega zdravljenja jemali zdravilo Vimpat v odmerku 200 mg na dan, in 40 % bolnikov, ki so poleg obstoječega zdravljenja jemali zdravilo Vimpat v odmerku 400 mg na dan, število epileptičnih napadov zmanjšalo vsaj za pol.
For the full list of all side effects and restrictions with Vimpat, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Vimpat glejte navodilo za uporabo.
How is Vimpat used?
Kako se zdravilo Vimpat uporablja?
The main measure of effectiveness was the number of patients whose number of seizures was at least halved after 12 weeks of treatment with a stable dose.
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih se je število epileptičnih napadov po 12 tednih zdravljenja z ustaljenim odmerkom vsaj prepolovilo.
An additional study in 118 patients was carried out to test that starting treatment with doses of 200 mg Vimpat by infusion, followed by regular doses taken by mouth, can be applied safely and that adequate levels in the body are achieved.
Dodatna študija je bila izvedena pri 118 bolnikih z namenom proučevanja varnosti začetnega zdravljenja z infundiranjem 200-miligramskega odmerka zdravila Vimpat, ki mu sledijo vzdrževalni odmerki, zaužiti peroralno, in ugotavljanja, ali to privede do ustreznih ravni zdravilne učinkovine v telesu.
Vimpat can only be obtained with a prescription and is available as tablets (50 mg; 100 mg; 150 mg; 200 mg), as a syrup (10 mg/ml) and as a solution for infusion (drip) into a vein.
Na voljo je v obliki tablet (50 mg, 100 mg, 150 mg, 200 mg), kot sirup (10 mg/ml) in raztopina za infundiranje (kapalna infuzija) v veno.
For more details see the package leaflet.
Za več informacij glejte navodilo za uporabo.
How does Vimpat work?
Kako zdravilo Vimpat deluje?
Side effects affecting the nervous system such as dizziness may be higher after a loading dose and dizziness was the most common reason for stopping treatment.
Neželeni učinki, ki prizadenejo živčni sistem, kot je na primer omotica, utegnejo biti večji po uporabi polnilnega odmerka.
The active substance in Vimpat, lacosamide, is an epilepsy medicine.
Zdravilna učinkovina v zdravilu Vimpat, lakozamid, je zdravilo proti epilepsiji.
It contains the active substance lacosamide.
Vsebuje zdravilno učinkovino lakozamid.
Patients were given Vimpat by mouth at a dose of 200 mg, 400 mg or 600 mg a day, or placebo in addition to their existing treatment of up to three other epilepsy medicines.
Bolniki so poleg obstoječega zdravljenja z največ tremi drugimi zdravili proti epilepsiji začeli peroralno jemati tudi zdravilo Vimpat v odmerku 200 mg, 400 mg ali 600 mg na dan ali placebo.
• Risk Management Plan (RMP)
- Načrt za obvladovanje tveganja (RMP)
Alternative treatments should be considered.
Razmisliti je treba o alternativnem zdravljenju.
They are available in packs of:
Na voljo so v pakiranjih po:
Your doctor will check this.
To bo preveril vaš zdravnik.
These medicinal products should be used with caution.
Ta zdravila je treba uporabljati previdno.
Special considerations for patients who smoke
Posebno opozorilo za bolnike, ki kadijo
Riociguat has a dual mode of action.
Riociguat ima dvojni mehanizem delovanja.
Your doctor may decide to monitor your blood pressure.
Zdravnik se lahko odloči, da bo spremljal vaš krvni tlak.
No such effects were observed in adult rats.
Teh učinkov pri odraslih podganah niso opazili.
The relevance of this finding for humans is unknown.
Pomen teh izsledkov za ljudi ni znan.
In case of pronounced hypotension, active cardiovascular support may be required.
V primeru močno izražene hipotenzije je lahko potrebna aktivna kardiovaskularna podpora.
• inoperable CTEPH,
• neoperabilno CTEPH,
The absolute bioavailability of riociguat is high (94%).
Absolutna biološka uporabnost riociguata je velika (94 %).
The use of Adempas in children and adolescents (under 18 years of age) should be avoided because efficacy and safety have not been established for this age group.
Uporabi zdravila Adempas pri otrocih in mladostnikih (starih manj kot 18 let) se je treba izogibati, ker učinkovitost in varnost nista bili dokazani za to starostno skupino.
Until more is known about the implications of these findings the use of riociguat in children and in growing adolescents should be avoided.
Dokler ni znanega več o pomenu teh izsledkov, se je treba uporabi riociguata pri otrocih in odraščajočih mladostnikih izogibati.
This also includes recreational drugs called poppers.
To vključuje tudi rekreacijske droge, t. i. »poppers«.
Terminal half-life increased from 7.3 to 9.2 hours and total body clearance decreased from 6.1 to 2.4 L/h.
Končni razpolovni čas se je povečal s 7,3 na 9,2 ure, celokupni očistek iz telesa pa se je zmanjšal s 6,1 na 2,4 l/h.
Monthly pregnancy tests are recommended.
Priporoča se mesečna uporaba testov za ugotavljanje nosečnosti.
Tablets can generally be taken with or without food.
Tablete se lahko jemljejo s hrano ali brez nje.
Frequencies are defined as: very common (≥1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Elimination half-life is about 7 hours in healthy subjects and about 12 hours in patients.
Razpolovni čas izločanja je pri zdravih osebah približno 7 ur, pri bolnikih pa 12 ur.
Improved Stable Deteriorated p-value
izboljšanje stabilno poslabšanje vrednost p
Doses above 1 mg riociguat were not investigated in this study.
Odmerkov, večjih od 1 mg riociguata, v tej študiji niso preučevali.
Six patients (10%) experienced at least one clinical worsening event, including 2 deaths unrelated to study drug.
Šest bolnikov (10 %) je imelo vsaj eno klinično poslabšanje, vključno z dvema smrtnima primeroma, ki nista bila povezana z zdravilom v preskušanju.
Your doctor will check if Adempas is suitable for you.
Vaš zdravnik bo preveril, če je zdravilo Adempas primerno za vas.
The safety and efficacy of riociguat in children and adolescents below 18 years have not been established.
Varnost in učinkovitost riociguata pri otrocih in mladostnikih, starih manj kot 18 let, nista bili dokazani.
Date of latest renewal: 18 January 2019
Datum prve odobritve: 27. marec 2014 Datum zadnjega podaljšanja: 18. januar 2019
If you smoke, it is recommended that you stop, as smoking may reduce the effectiveness of these tablets.
Če kadite, je priporočljivo prenehati s kajenjem, saj lahko kajenje zmanjša učinkovitost teh tablet.
The most serious side effects are:
Najbolj resni neželeni učinki so:
If your blood pressure drops (which can make you feel dizzy) then you may need immediate medical attention.
Če se vam krvni tlak naglo zniža (zaradi česar ste lahko omotični), morda potrebujete takojšnjo zdravniško pomoč.
Plasma concentrations of riociguat in smokers are reduced compared to non-smokers.
Koncentracije riociguata v plazmi so pri kadilcih manjše kot pri nekadilcih.