FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the magnitude of effect of bilirubin is modest (compared to the typical patient with a bilirubin of 0.6 mg/dl, a patient with an elevated bilirubin of 4.5 mg/dl would have approximately 30% lower oral clearance of ambrisentan).
Slovenian: Vendar pa je obseg vpliva bilirubina zmeren (v primerjavi s tipičnim bolnikom z vrednostjo bilirubina 0,6 mg/dl, bo imel bolnik z zvišano vrednostjo bilirubina 4,5 mg/dl približno za 30 % manjši očistek ambrisentana po peroralni uporabi).
English: These changes in exposure to ethinyl estradiol or norethindrone were small and are unlikely to be clinically significant (see section 4.5).
Slovenian: Te spremembe izpostavljenosti etinilestradiolu in noretindronu so majhne in ni verjetno, da bi bile klinično pomembne (glejte poglavje 4.5).
English: In addition, the rat study showed an increased incidence of interventricular septal defects, trunk vessel defects, thyroid and thymus abnormalities, ossification of the basisphenoid bone, and the occurrence of the umbilical artery located on the left side of the urinary bladder instead of the right side.
Slovenian: Poleg tega je študija na podganah pokazala večjo pojavnost defektov medprekatnega pretina, defektov trunkusnih žil, nepravilnosti ščitnice in timusa, osifikacij bazisfenoidne kosti in poteka umbilikalne arterije na levi strani sečnega mehurja namesto na desni.
English: • abnormal blood test results for liver function
Slovenian: • nenormalni izvidi krvnih preiskav delovanja jeter,
English: Ambrisentan is absorbed rapidly in humans.
Slovenian: Absorpcija ambrisentana pri človeku je hitra.
English: This prevents endothelin-mediated activation of second messenger systems that result in vasoconstriction and smooth muscle cell proliferation.
Slovenian: Na ta način prepreči z endotelinom povzročeno aktivacijo sekundarnega sporočilnega sistema, kar ima za posledico vazokonstrikcijo in proliferacijo gladkih mišičnih celic.
English: If patients have pre-existing fluid overload, this should be managed as clinically appropriate prior to starting ambrisentan.
Slovenian: Če pri bolniku že obstaja preobremenitev s tekočino, je to treba klinično ustrezno obvladati pred začetkom zdravljenja z ambrisentanom.
English: The usual dose of Ambrisentan Mylan is one 5 mg tablet, once a day.
Slovenian: Običajni odmerek zdravila Ambrisentan Mylan je ena 5 mg tableta enkrat na dan.
English: The symptoms of your condition can also make you less fit to drive or use machines.
Slovenian: Tudi simptomi vaše bolezni lahko poslabšajo vašo sposobnost upravljanja vozil in strojev.
English: Steady-state is generally achieved following 4 days of repeat dosing.
Slovenian: Stanje dinamičnega ravnovesja je običajno doseženo po 4-dnevnem zdravljenju.
English: A total of 17 patients (6.5%) in the ambrisentan treatment groups had decreases in haemoglobin of ≥15% from baseline and which fell below the lower limit of normal.
Slovenian: V skupini, ki je prejemala ambrisentan, se je pri skupno 17 bolnikih (6,5 %) koncentracija hemoglobina od izhodišča znižala za ≥ 15 % in je bila nižja od spodnje meje normalne vrednosti.
English: If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy test before you start taking Ambrisentan Mylan and regularly while you are taking this medicine.
Slovenian: Če ste ženska v rodni dobi, bo zdravnik opravil test za ugotavljanje nosečnosti pred začetkom zdravljenja z zdravilom Ambrisentan Mylan in redno med jemanjem tega zdravila.
English: Ambrisentan is a non-sulphonamide (propanoic acid) ERA.
Slovenian: Ambrisentan je nesulfonamidni (propanojska kislina) ERA.
English: Following initial doses of rifampicin, a transient increase in ambrisentan AUC(0-τ) (121% and 116% after first and second doses of rifampicin, respectively) was observed, presumably due to a rifampicin-mediated OATP inhibition.
Slovenian: Po začetnih odmerkih rifampicina so ugotovili prehodno povečanje AUC(0-τ) ambrisentana (121 % po prvem in 116 % po drugem odmerku rifampicina), verjetno zaradi zavrtja OATP z rifampicinom.
English: The MAH will agree the distribution plan with the National Competent Authorities before the product launch in each territory and will ensure that all patients taking Ambrisentan Mylan have been provided with the relevant educational materials.
Slovenian: Pred prihodom zdravila na trg se mora imetnik dovoljenja za promet z zdravilom s pristojnimi nacionalnimi organi dogovoriti o načrtu razdeljevanja in poskrbeti, da bodo vsi bolniki, ki jemljejo zdravilo Ambrisentan Mylan, prejeli ustrezno izobraževalno gradivo.
English: A decrease in plasma inhibin-B concentration and an increase in plasma FSH concentration were observed.
Slovenian: Ugotovili so znižanje plazemske koncentracije inhibina B in zvišanje plazemske koncentracije FSH.
English: It is recommended that haemoglobin and/or haematocrit levels are measured during treatment with ambrisentan, for example at 1 month, 3 months and periodically thereafter in line with clinical practice.
Slovenian: Med zdravljenjem z ambrisentanom je priporočljivo spremljati vrednosti hemoglobina in/ali hematokrita, na primer 1. in 3. mesec, nato pa periodično v skladu s klinično prakso.
English: Hepatic transaminases increased
Slovenian: zvišanje jetrnih transaminaz
English: Consequently, if PAH patients develop acute pulmonary oedema when treated with ambrisentan, the possibility of pulmonary veno-occlusive disease should be considered.
Slovenian: Če se bolnikom s PAH med zdravljenjem z ambrisentanom razvije akutni pljučni edem, je treba upoštevati možnost pljučne venookluzivne bolezni.
English: • a runny or blocked nose, congestion or pain in the sinuses
Slovenian: • izcedek iz nosu ali zmašen nos, kongestija ali bolečine v obnosnih votlinah (sinusih),
English: This is a very common side effect that may affect more than one in 10 people.
Slovenian: To je zelo pogost neželen učinek, ki se lahko pojavi pri več kot 1 od 10 bolnikov.
English: Women of child-bearing potential who are not using reliable contraception (see sections 4.4 and 4.6).
Slovenian: Ženske v rodni dobi, ki ne uporabljajo zanesljive kontracepcijske metode (glejte poglavji 4.4 in 4.6).
English: Although no clear evidence of a detrimental effect of ambrisentan long-term exposure on sperm count was found in ARIES-E study, chronic administration of ambrisentan was associated with changes in markers of spermatogenesis.
Slovenian: Čeprav študija ARIES-E ni prinesla nobenih jasnih dokazov o škodljivih učinkih dolgoročne izpostavljenosti ambrisentanu na število semenčic, je bila kronična uporaba ambrisentana povezana s spremenjenimi označevalci spermatogeneze.
English: The effect of ambrisentan on male human fertility is not known.
Slovenian: Vpliv ambrisentana na plodnost moških ni znan.
English: If you take more Ambrisentan Mylan than you should If you take too many tablets you may be more likely to have side effects, such as headache, flushing, dizziness, nausea (feeling sick), or low blood pressure that could cause light-headedness:
Slovenian: Če ste vzeli večji odmerek zdravila Ambrisentan Mylan, kot bi smeli Če vzamete preveč tablet, obstaja večja verjetnost, da se vam pojavijo neželeni učinki, npr. glavobol, zardevanje, omotica, siljenje na bruhanje (slabost v želodcu) ali nizek krvni tlak, ki lahko povzroči vrtoglavico.
English: Clinical efficacy in combination with tadalafil
Slovenian: Klinična učinkovitost v kombinaciji s tadalafilom
English: Ambrisentan Mylan tablets contain small amounts of a sugar called lactose.
Slovenian: Tablete Ambrisentan Mylan vsebujejo majhno količino sladkorja, imenovanega laktoza.
English: Effect of ambrisentan on xenobiotic transporters
Slovenian: Vpliv ambrisentana na ksenobiotske prenašalce
English: In male rats, there were no effects of ambrisentan on sperm motility at all doses tested (up to 300 mg/kg/day).
Slovenian: Pri podganjih samcih ambrisentan ni vplival na gibljivost semenčic pri nobenem od testiranih odmerkov (do 300 mg/kg/dan).
English: If patients develop sustained, unexplained, clinically significant ALT and/or AST elevation, or if ALT and/or AST elevation is accompanied by signs or symptoms of hepatic injury (e.g. jaundice), ambrisentan therapy should be discontinued.
Slovenian: Če se pri bolniku razvije trajajoče, nepojasnjeno, klinično pomembno zvišanje ALT in/ali AST ali če zvišanje vrednosti ALT in/ali AST spremljajo znaki in simptomi okvare jeter (npr. zlatenica), je treba zdravljenje z ambrisentanom prekiniti.
English: The observed probability of survival for subjects receiving ambrisentan (combined ambrisentan dose group) at 1, 2 and 3 years was 93%, 85% and 79% respectively.
Slovenian: Opažena verjetnost preživetja preiskovancev, ki so prejemali ambrisentan (skupina s kombiniranimi odmerki ambrisentana) je bila 93 % po 1 letu, 85 % po 2 letih in 79 % po 3 letih.
English: Ambrisentan is an orally active, propanoic acid-class, ERA selective for the endothelin A (ETA) receptor.
Slovenian: Ambrisentan je peroralno delujoč antagonist endotelinskih receptorjev (ERA) iz razreda propanojske kisline, selektiven za receptorje endotelin A (ETA).
English: • flushing (redness of the skin)
Slovenian: • zardevanje (pordelost kože),
English: Ambrisentan does not undergo significant renal metabolism or renal clearance (excretion).
Slovenian: Ambrisentan ni podvržen pomembni ledvični presnovi ali ledvičnemu očistku (izločanju).
English: Therefore at concentrations observed in the plasma (approximately 4% relative to parent ambrisentan), 4-hydroxymethyl ambrisentan is not expected to contribute to pharmacological activity of ambrisentan.
Slovenian: Pri koncentracijah, opaženih v plazmi (približno 4 % v primerjavi z izvornim ambrisentanom), torej ne pričakujemo, da bi 4-hidroksimetil ambrisentan prispeval k farmakološki aktivnosti ambrisentana.
English: A statistically significant increase (3.41 ± 6.96) was observed for the combined dose group in the physical functioning scale of the SF-36 Health Survey compared with placebo (-0.20 ± 8.14, p=0.005).
Slovenian: V skupini s kombiniranim odmerkom je bilo opaženo statistično pomembno izboljšanje (3,41 ± 6,96) na lestvici telesne zmogljivosti vprašalnika o kakovosti življenja SF-36 (SF-36 Health Survey) v primerjavi s placebom (−0,20 ± 8,14, p = 0,005).
English: Systemic exposure to ambrisentan in male rats at this dose (based on steady-state AUC) was 6-fold that achieved at the 10 mg/day clinical dose.
Slovenian: Sistemska izpostavljenost ambrisentanu je bila pri podganjih samcih ob tem odmerku (na podlagi AUC v stanju dinamičnega ravnovesja) 6-krat tolikšna, kot je dosežena s kliničnim odmerkom 10 mg/dan.
English: This change in exposure is unlikely to be of any clinical relevance and therefore ambrisentan may be co-administered with ketoconazole.
Slovenian: Verjetnost, da bi te spremembe v izpostavljenosti imele kakršenkoli klinični pomen, je majhna, zato se ambrisentan lahko uporablja skupaj s ketokonazolom.
English: When used in combination with tadalafil, patients were initiated with 5 mg ambrisentan and 20 mg tadalafil.
Slovenian: Med uporabo v kombinaciji s tadalafilom so bolniki zdravljenje začeli s 5 mg ambrisentana in 20 mg tadalafila.
English: Ambrisentan also undergoes oxidative metabolism mainly by CYP3A4 and to a lesser extent by CYP3A5 and CYP2C19 to form 4-hydroxymethyl ambrisentan (21%) which is further glucuronidated to 4-hydroxymethyl ambrisentan glucuronide (5%).
Slovenian: Ambrisentan se tudi oksidativno presnavlja, predvsem s CYP3A4 in v manjšem obsegu s CYP3A5 in CYP2C19, do 4-hidroksimetil ambrisentana (21 %), ki se nadalje glukuronidira do 4-hidroksimetil ambrisentan glukuronida (5 %).
English: If you are a man taking Ambrisentan Mylan, it is possible that this medicine may lower your sperm count.
Slovenian: Če ste moški in jemljete zdravilo Ambrisentan Mylan, vam to zdravilo lahko zmanjša število semenčic.
English: Blood and lymphatic system disorders Anaemia (decreased haemoglobin, decreased haematocrit)
Slovenian: Bolezni krvi in limfatičnega sistema anemija (znižana vrednost hemoglobina, znižana vrednost hematokrita)
English: The effect was significant for both FC II and FC III patients.
Slovenian: Učinek je bil značilen tako pri bolnikih v II.
English: Approximately 22% of the administered dose is recovered in the urine following oral administration with 3.3% being unchanged ambrisentan.
Slovenian: V urinu se pojavi približno 22 % peroralno prejetega odmerka, od tega 3,3 % ambrisentana v nespremenjeni obliki.
English: Ambrisentan Mylan is to be taken orally to begin at a dose of 5 mg once daily and may be increased to 10 mg daily depending upon clinical response and tolerability.
Slovenian: Zdravilo Ambrisentan Mylan bolnik jemlje peroralno v začetnem odmerku 5 mg enkrat na dan; odmerek je mogoče povečati na 10 mg na dan, odvisno od kliničnega odziva in prenašanja.
English: If a clinically significant decrease in haemoglobin or haematocrit is observed, and other causes have been excluded, dose reduction or discontinuation of treatment should be considered.
Slovenian: Če se vrednost hemoglobina ali hematokrita klinično pomembno zmanjša in se drugi vzroki izključijo, je treba razmisliti o zmanjšanju odmerka ali prekinitvi zdravljenja.
English: In a population pharmacokinetic analysis, creatinine clearance was found to be a statistically significant covariate affecting the oral clearance of ambrisentan.
Slovenian: Pri analizi populacijske farmakokinetike je bilo ugotovljeno, da je očistek kreatinina statistično pomembna kovariata, ki vpliva na očistek peroralno prejetega ambrisentana.
English: You can take Ambrisentan Mylan with or without food.
Slovenian: Tableto zdravila Ambrisentan Mylan lahko vzamete s hrano ali brez nje.
English: Ambrisentan blocks the ETA receptor subtype, localized predominantly on vascular smooth muscle cells and cardiac myocytes.
Slovenian: Ambrisentan blokira podtip receptorjev ETA, ki se nahajajo predvsem v gladkih mišičnih celicah žilne stene in srčnih miocitih.
English: Ambrisentan (ARIES-C and post marketing)
Slovenian: Ambrisentan (ARIES-C in po prihodu zdravila na trg)
English: Ambrisentan Mylan may cause side effects, such as low blood pressure, dizziness, tiredness (see section 4), that may affect your ability to drive or use machines.
Slovenian: Zdravilo Ambrisentan Mylan lahko povzroči neželene učinke, npr. nizek krvni tlak, omotico, utrujenost (glejte poglavje 4), ki lahko poslabšajo vašo sposobnost upravljanja vozil in strojev.
English: Cases of worsening dyspnoea of unclear aetiology have been reported shortly after starting ambrisentan therapy.
Slovenian: Opisani so bili primeri poslabšanja dispneje nejasne etiologije, ki se je pojavila kmalu po začetku zdravljenja z ambrisentanom.
English: Data derived from routine pharmacovigilance surveillance Most of the reported cases of cardiac failure were associated with fluid retention.
Slovenian: Podatki iz rednega farmakovigilančnega spremljanja Večina opisanih primerov srčnega popuščanja je bila povezana z zastajanjem tekočine.
English: Eye disorders Blurred vision, visual impairment
Slovenian: Očesne bolezni zamegljen vid, okvara vida neznana
English: Sudden hearing loss
Slovenian: nenadna izguba sluha
English: Ambrisentan is glucuronidated via several UGT isoenzymes (UGT1A9S, UGT2B7S and UGT1A3S) to form ambrisentan glucuronide (13%).
Slovenian: Ambrisentan se glukuronidira s številnimi UGT izoencimi (UGT1A9S, UGT2B7S in UGT1A3S), pri čemer se tvori ambrisentan glukuronid (13 %).
English: Time to First Hospitalisation for Worsening PAH (Adjudicated) First hospitalisation, no. (%)
Slovenian: Čas od prvega sprejema v bolnišnico zaradi poslabšanja PAH (presojeno) Prvi sprejem v bolnišnico, št. (%)
English: Treatment with ambrisentan resulted in an increase in mean cardiac index, a decrease in mean pulmonary artery pressure, and a decrease in mean pulmonary vascular resistance.
Slovenian: Zaradi zdravljenja z ambrisentanom se je povečal srednji srčni indeks, zmanjšal srednji pljučni arterijski krvni tlak in zmanjšal srednji pljučni žilni upor.
English: Dependent on tolerability the dose of tadalafil was increased to 40 mg after 4 weeks and the dose of ambrisentan was increased to 10 mg after 8 weeks.
Slovenian: Odvisno od prenašanja so odmerek tadalafila po 4 tednih povečali na 40 mg, odmerek ambrisentana pa po 8 tednih na 10 mg.
English: Ambrisentan is highly plasma protein bound.
Slovenian: Ambrisentan se v velikem obsegu veže na plazemske proteine.
English: • lung disease where the veins in the lungs are blocked (pulmonary veno-occlusive disease).
Slovenian: • pljučno bolezen z zaporo ven v pljučih (pljučna venookluzivna bolezen).
English: In patients without clinical symptoms of hepatic injury or of jaundice, re-initiation of ambrisentan may be considered following resolution of hepatic enzyme abnormalities.
Slovenian: Pri bolnikih brez kliničnih simptomov okvare jeter ali zlatenice se lahko o ponovni uvedbi zdravljenja z ambrisentanom razmisli, ko se nepravilnosti jetrnih encimov odpravijo.
English: What you need to know before you take Ambrisentan Mylan
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Ambrisentan Mylan
English: Ambrisentan Mylan widens the pulmonary arteries, making it easier for the heart to pump blood through them.
Slovenian: Zdravilo Ambrisentan Mylan širi pljučne arterije in tako srcu olajša potiskanje krvi v njih.
English: With the exception of a 13% increase in sildenafil Cmax following co-administration with ambrisentan, there were no other changes in the pharmacokinetic parameters of sildenafil, N-desmethyl-sildenafil and ambrisentan.
Slovenian: Z izjemo 13-odstotnega povečanja vrednosti Cmax sildenafila pri sočasni uporabi ambrisentana drugih sprememb farmakokinetičnih parametrov sildenafila, N-desmetil-sildenafila in ambrisentana niso zasledili.
English: 30 film-coated tablets 30x1 film-coated tablets.
Slovenian: 30 filmsko obloženih tablet 30 × 1 filmsko obložena tableta
English: Idiopathic pulmonary fibrosis (IPF), with or without secondary pulmonary hypertension (see section 5.1).
Slovenian: Idiopatska pljučna fibroza (IPF) s sekundarno pljučno hipertenzijo ali brez nje (glejte poglavje 5.1).
English: → Ask your doctor or pharmacist for advice if you take more tablets than prescribed.
Slovenian: → Posvetujte se s svojim zdravnikom ali s farmacevtom, če ste vzeli več tablet, kot vam je predpisal zdravnik.
English: Patients with pre-existent hepatic disease (cirrhosis or clinically significantly elevated aminotransferases) and patients using other targeted therapy for PAH (e.g. prostanoids) were excluded.
Slovenian: Bolniki, ki so že imeli bolezen jeter (ciroza ali klinično pomembno zvišanje aktivnosti aminotransferaz), in bolniki, ki so se zdravili z drugo obliko usmerjenega zdravljenja PAH (npr. s prostanoidi), so bili izključeni.
English: • inflammation of the liver caused by the body's own defences (autoimmune hepatitis) In combination with tadalafil
Slovenian: • vnetje jeter, ki ga povzroči lastni obrambni sistem telesa (avtoimunski hepatitis).
English: If there is any doubt on what contraceptive advice should be given to the individual patient, consultation with a gynaecologist should be considered.
Slovenian: V primeru dvoma o primerni obliki kontracepcije pri posamezni bolnici je treba pridobiti mnenje ginekologa.
English: When co-administered with cyclosporine A, the dose of ambrisentan should be limited to 5 mg once daily and the patient should be carefully monitored (see sections 4.5 and 5.2).
Slovenian: Med sočasno uporabo s ciklosporinom A je treba odmerek ambrisentana omejiti na 5 mg enkrat na dan, bolnika pa je treba pozorno spremljati (glejte poglavji 4.5 in 5.2).
English: Most cases of peripheral oedema in clinical studies with ambrisentan were mild to moderate in severity, although it may occur with greater frequency and severity in patients ≥65 years.
Slovenian: V kliničnih študijah je bil periferni edem v večini primerov blag do zmeren, vendar pa se lahko pojavi pri bolnikih, starih ≥ 65 let, pogosteje in v hujši obliki.
English: In a population pharmacokinetic analysis, the oral clearance was shown to be decreased as a function of increasing bilirubin levels.
Slovenian: Pri analizi populacijske farmakokinetike so ugotovili, da se očistek po peroralni uporabi zmanjša v odvisnosti od zvišanja vrednosti bilirubina.
English: Other side effects include
Slovenian: Med drugimi neželenimi učinki so
English: 6MWD (metres, median change)
Slovenian: 6-minutna prehojena razdalja (metri, mediana sprememba)
English: If you forget to take Ambrisentan Mylan
Slovenian: Če ste pozabili vzeti zdravilo Ambrisentan Mylan
English: The number of patients who received concomitant ambrisentan and sildenafil in ARIES-E and AMB222 was 22 patients (5.7%) and 17 patients (47%), respectively.
Slovenian: Ambrisentan in sildenafil je v študiji ARIES-E sočasno uporabljalo 22 bolnikov (5,7 %), v študiji AMB222 pa 17 bolnikov (47 %).
English: The Cmax and AUC(0-∞) were slightly decreased for ethinyl estradiol (8% and 4%, respectively), and slightly increased for norethindrone (13% and 14%, respectively).
Slovenian: Cmax in AUC(0-∞) etinilestradiola sta se rahlo zmanjšali (Cmax za 8 % in AUC za 4 %), noretindrona pa rahlo povečali (Cmax za 13 % in AUC(0-∞) za 14 %).
English: In placebo controlled clinical trials of 12 weeks duration mean reduction in systolic and diastolic blood pressures from base line to end of treatment were 3 mm Hg and 4.2 mm Hg respectively.
Slovenian: V 12-tedenskih s placebom kontroliranih kliničnih preskušanjih je bilo povprečno znižanje sistoličnega krvnega tlaka od izhodišča do konca zdravljenja 3 mmHg in diastoličnega krvnega tlaka 4,2 mmHg.
English: Multiple doses of ambrisentan resulted in slight increases in digoxin AUC0-last and trough concentrations, and a 29% increase in digoxin Cmax.
Slovenian: Pri ponavljajočih se odmerkih ambrisentana so ugotovili rahlo zvišanje vrednosti AUC0-last digoksina in najmanjših koncentracij digoksina v stanju dinamičnega ravnovesja ter zvišanje vrednosti Cmax digoksina za 29 %.
English: The other ingredients are lactose, see section 2, ‘Ambrisentan Mylan contains lactose', microcrystalline cellulose (E460i), sodium croscarmellose, magnesium stearate (E570), polyvinyl alcohol part hydrolysed, titanium dioxide (E171), macrogol/PEG, talc (E553b), Allura red (E129), see section 2 ‘Ambrisentan Mylan contains Allura red (E129)', Indigo carmine (E132)
Slovenian: Druge sestavine so laktoza, glejte poglavje 2, „Zdravilo Ambrisentan Mylan vsebuje laktozo“, mikrokristalna celuloza (E460i), natrijev karmelozat, premreženi, magnezijev stearat (E570), delno hidrolizirani polivinil alkohol, titanov dioksid (E171), makrogol/PEG, smukec (E553b), alurno rdeče (E129), glejte poglavje 2 „Zdravilo Ambrisentan Mylan vsebuje alurno rdeče barvilo (E129)“, indigotin (E132)
English: ARIES-2 included 192 patients and compared ambrisentan 2.5 mg and 5 mg with placebo.
Slovenian: Študija ARIES-2, ki je vključevala 192 bolnikov, je primerjala uporabo ambrisentana v odmerku 2,5 mg in 5 mg s placebom.
English: Due to the mechanism of action, an overdose of ambrisentan could potentially result in hypotension (see section 5.3).
Slovenian: V primeru prevelikega odmerka ambrisentana se zaradi mehanizma delovanja zdravila lahko pojavi hipotenzija (glejte poglavje 5.3).
English: In vitro studies in rat hepatocytes also showed that ambrisentan did not induce Pgp, BSEP or MRP2 protein expression.
Slovenian: Tudi študije na podganjih jetrnih parenhimskih celicah in vitro so pokazale, da ambrisentan ne inducira ekspresije beljakovin Pgp, BSEP ali MRP2.
English: In the post-marketing period, cases of anaemia requiring blood cell transfusion have been reported (see section 4.8).
Slovenian: Med obdobjem trženja so bili opisani primeri anemije, ki so zahtevali transfuzijo krvnih celic (glejte poglavje 4.8).
English: • That Ambrisentan Mylan is teratogenic in animals
Slovenian: • da je zdravilo Ambrisentan Mylan pri živalih teratogeno,
English: This slight increase in sildenafil Cmax is not considered clinically relevant (see section 4.5).
Slovenian: To rahlo povečanje vrednosti Cmax sildenafila ni klinično pomembno (glejte poglavje 4.5).