natgillin/translations-raw huggingface dataset:
In the post-marketing period, cases of anaemia requiring red blood cell transfusion have been reported (see section 4.8).
V obdobju po uvedbi zdravila na trg so poročali o primerih anemije, zaradi katere je bila potrebna transfuzija eritrocitov (glejte poglavje 4. 8).
Tracleer treatment must not be initiated in women of child-bearing potential unless they practice reliable contraception (see section 4.5) and the result of the pre-treatment pregnancy test is negative (see section 4.6).
Zdravljenja z zdravilom Tracleer ne uvajamo pri ženskah v rodni dobi, če ne uporabljajo zanesljive kontracepcije (glejte poglavje 4. 5) in če test nosečnosti pred začetkom zdravljenja ni negativen (glejte poglavje 4. 6).
Patients and prescribers must be aware that, due to potential pharmacokinetic interactions, Tracleer may render hormonal contraceptives ineffective (see section 4.5).
Bolnica in zdravnik, ki zdravilo predpiše, se mora zavedati, da lahko zaradi možnih farmakokinetičnih interakcij zdravilo Tracleer povzroči neučinkovitost hormonske kontracepcije (glejte poglavje 4. 5).
Therefore, women of child-bearing potential must not use hormonal contraceptives (including oral, injectable, transdermal, and implantable forms) as the sole method of contraception but should use an additional or an alternative reliable method of contraception.
Zato ženske v rodni dobi ne smejo uporabljati hormonske kontracepcije (vključno s peroralnimi, transdermalnimi oblikami, oblikami za vbrizganje in vsadki) kot edinega načina kontracepcije, temveč morajo uporabljati dodatno ali drugo zanesljivo metodo kontracepcije.
If there is any doubt on what contraceptive advice should be given to the individual patient, consultation with a gynaecologist is recommended.
V primeru dvoma v zvezi z načinom kontracepcije, ki se svetuje posamični bolnici, se priporoča posvetovanje z ginekologom.
Because of possible hormonal contraception failure during Tracleer treatment and also bearing in mind the risk that pulmonary hypertension severely deteriorates with pregnancy, monthly pregnancy tests during treatment with Tracleer are recommended to allow early detection of pregnancy.
Zaradi možne odpovedi hormonske kontracepcije v času zdravljenja z zdravilom Tracleer in ob upoštevanju tveganja, da se pljučna hipertenzija z nosečnostjo hudo poslabša, se v času zdravljenja z zdravilom Tracleer priporočajo mesečni testi nosečnosti za zgodnje odkrivanje nosečnosti.
5 Pulmonary veno-occlusive disease
5 Pljučna venookluzivna bolezen
Cases of pulmonary oedema have been reported with vasodilators (mainly prostacyclins) when used in patients with pulmonary veno-occlusive disease.
Pri uporabi vazodilatatorjev (zlasti prostaciklinov) pri bolnikih s pljučno vensko okluzivno boleznijo so poročali o primerih pljučnega edema.
Consequently, should signs of pulmonary oedema occur when Tracleer is administered in patients with PAH, the possibility of associated veno-occlusive disease should be considered.
Zato moramo v primeru, da se pri bolnikih s PAH, ko prejemajo Tracleer, pojavijo znaki pljučnega edema, pomisliti na možnost povezane venske okluzivne bolezni.
In the post-marketing period there have been rare reports of pulmonary oedema in patients treated with Tracleer who had a suspected diagnosis of pulmonary veno-occlusive disease.
V obdobju po uvedbi zdravila na trg so pri bolnikih, zdravljenih z zdravilom Tracleer, pri katerih so sumili na pljučno vensko okluzivno bolezen, o pljučnem edemu poročali redko.
However, 1,611 patients (804 Tracleer- and 807 placebo-treated patients) with severe chronic heart failure (CHF) were treated for a mean duration of 1.5 years in a placebo- controlled study (study AC-052-301/ 302 [ENABLE 1 & 2]).
Je pa v s placebom nadzorovani študiji (študija AC- 052- 301/ 302 [ENABLE 1 & 2]) s povprečnim trajanjem zdravljenja 1, 5 let sodelovalo 1611 bolnikov (804 bolniki so jemali zdravilo Tracleer, 807 bolnikov je prejemalo placebo) s hudim kroničnim srčnim popuščanjem (CHF – Chronic Hearth Failure).
In this study there was an increased incidence of hospitalisation due to CHF during the first 4 - 8 weeks of treatment with Tracleer, which could have been the result of fluid retention.
V tej študiji je bilo število primerov hospitalizacije zaradi CHF v prvih 4– 8 tednih zdravljenja z zdravilom Tracleer povečano, kar je lahko bila posledica zadrževanja tekočine.
In this study, fluid retention was manifested by early weight gain, decreased haemoglobin concentration and increased incidence of leg oedema.
V tej študiji se je zadrževanje tekočine pokazalo kot zgodnje povečanje telesne mase, znižanje koncentracije hemoglobina in povečanje števila primerov oteklin spodnjih okončin.
At the end of this study, there was no difference in overall hospitalisations for heart failure nor in mortality between Tracleer- and placebo-treated patients.
Na koncu študije med bolniki, ki so jemali zdravilo Tracleer, in bolniki, ki so prejemali placebo, ni bilo razlike niti v skupnem številu hospitalizacij zaradi srčnega popuščanja niti v umrljivosti.
Consequently, it is recommended that patients be monitored for signs of fluid retention (e. g., weight gain), especially if they concomitantly suffer from severe systolic dysfunction.
Zato priporočamo, da bolnike opazujemo glede pojava znakov zadrževanja tekočine (denimo, povečanje telesne mase) in to še zlasti, če imajo sočasno hudo sistolično disfunkcijo.
There is limited clinical trial experience with the use of Tracleer in patients with PAH associated with HIV infection, treated with antiretroviral medicinal products (see section 5.1).
O uporabi zdravila Tracleer pri bolnikih s PAH, povezanim z okužbo s HIV, ki se zdravijo s protiretrovirusnimi zdravili, imamo omejene izkušnje iz kliničnih preskušanj (glejte poglavje 5. 1).
No specific interaction studies between bosentan and antiretroviral medicinal products have been performed.
Specifičnih študij medsebojnega delovanja med bosentanom in protiretrovirusnimi zdravili niso izvedli.
Due to the potential for such interactions especially related to the inducing effect of bosentan on CYP450 (see section 4.5), which could affect the efficacy of antiretroviral therapy, these patients should be monitored carefully regarding control of their HIV infection.
Zaradi možnosti takega medsebojnega delovanja zlasti v povezavi z učinkom bosentana na indukcijo encima CYP450 (glejte poglavje 4. 5), ki bi lahko vplivalo na učinkovitost protiretrovirusnega zdravljenja, moramo te bolnike skrbno spremljati v smislu nadzora njihove okužbe s HIV.
An increased risk of hepatic toxicity and haematological adverse events cannot be excluded when bosentan is used in combination with antiretroviral medicinal products.
Pri kombinaciji bonsetana s protiretrovirusnimi zdravili ni mogoče izključiti povečanega tveganja za nastanek jetrne toksičnosti in hematoloških neželenih učinkov.
Tracleer should not be used concomitantly with glibenclamide, due to an increased risk of elevated liver aminotransferases (see section 4.5).
Zdravila Tracleer ne smemo uporabljati sočasno z glibenklamidom zaradi večje nevarnosti za povišanje vrednosti jetrnih aminotransferaz (glejte poglavje 4. 5).
An alternative antidiabetic medicinal product should be used in patients in whom an antidiabetic treatment is indicated.
Pri bolnikih, ki antidiabetik potrebujejo, uporabite drugo zdravilo za zdravljenje sladkorne bolezni.
Fluconazole: concomitant use of Tracleer with fluconazole is not recommended (see section 4.5).
Sočasne uporabe flukonazola in zdravila Tracleer ne priporočamo (glejte poglavje 4. 5).
Although not studied, this combination may lead to large increases in plasma concentrations of bosentan.
Čeprav tega niso preučili, lahko ta kombinacija pripelje do velikega povišanja plazemske koncentracije bosentana.
Rifampicin: co-administration of Tracleer with rifampicin is not recommended (see section 4.5).
Sočasne uporabe zdravila Tracleer in rifampicina ne priporočamo (glejte poglavje 4. 5).
Concomitant administration of both a CYP3A4 inhibitor and a CYP2C9 inhibitor should be avoided (see section 4.5).
Izogibati se moramo sočasni uporabi zaviralcev CYP3A4 in CYP2C9 (glejte poglavje 4. 5).
The possibility 6 of altered efficacy of medicinal products metabolised by these isoenzymes should be considered.
Upoštevajte možnost spremenjene učinkovitosti zdravil, ki jih
Inhibition of these isoenzymes may increase the plasma concentration of bosentan (see ketoconazole).
Zavora teh izoencimov lahko poviša koncentracijo bosentana v plazmi (glejte ketokonazol).
Concomitant administration with fluconazole, which inhibits mainly CYP2C9, but to some extent also CYP3A4, could lead to large increases in plasma concentrations of bosentan.
Sočasno dajanje s flukonazolom, ki zavira predvsem CYP2C9, do določene mere pa tudi CYP3A4, lahko povzroči do veliko povišanje plazemskih koncentracij bosentana.
The combination is not recommended (see section 4.4).
Te kombinacije ne priporočamo (glejte poglavje 4. 4).
For the same reason, concomitant administration of both a potent CYP3A4 inhibitor (such as ketoconazole, itraconazole and ritonavir) and a CYP2C9 inhibitor (such as voriconazole) with Tracleer is not recommended (see section 4.4).
Iz istega razloga odsvetujemo sočasno uporabo zdravila Tracleer tako z močnim zaviralcem CYP3A4 (denimo, ketokonazolom, itrakonazolom in ritonavirjem) in tudi zaviralcem CYP2C9 (denimo, vorikonazolom) (glejte poglavje 4. 4).
Specific interaction studies have demonstrated the following:
Študije medsebojnega delovanja so pokazale naslednje:
Hormonal contraceptives:
Hormonska kontracepcija:
Co-administration of Tracleer 125 mg twice daily for 7 days with a single dose of oral contraceptive containing norethisterone 1 mg + ethinyl estradiol 35 mcg decreased the AUC of norethisterone and ethinyl estradiol by 14% and 31%, respectively.
Sočasno dajanje zdravila Tracleer 125 mg dvakrat na dan 7 dni s peroralnim kontracepcijskim sredstvom v enem odmerku, vsebujočim noretisteron 1 mg in etinil estradiol 35 μg, je zmanjšalo AUC noretisterona in etinil estradiola za 14% oziroma 31%.
However, decreases in exposure were as much as 56% and 66%, respectively, in individual subjects.
Pri posameznicah pa so bila zmanjšanja izpostavljenosti tudi do 56% oziroma 66%.
Therefore, hormone- based contraceptives alone, regardless of the route of administration (i. e. oral, injectable, transdermal, and implantable forms), are not considered as reliable methods of contraception (see sections 4.4, 4.6).
Zato kontracepcija, ki temelji samo na hormonih, ni zanesljiv način kontracepcije, ne glede na način apliciranja (npr. peroralno, parenteralno, transdermalno ali v obliki vsadka) (glejte poglavji 4. 4, 4. 6).
Cyclosporine A: co-administration of Tracleer and cyclosporine A (a calcineurin inhibitor) is contraindicated (see section 4.3).
Sočasna uporaba zdravila Tracleer in ciklosporina A (kalcinevrinski inhibitor) je kontraindicirana (glejte poglavje 4. 3).
Indeed, when co-administered, initial trough concentrations of bosentan were approximately 30-fold higher than those measured after bosentan alone.
Kadar so ju uporabljali sočasno, so bile izhodiščne koncentracije bosentana tik pred naslednjim odmerkom približno 30- krat višje kot koncentracije, izmerjene pri jemanju bosentana samega.
At steady state, bosentan plasma concentrations were 3- to 4-fold higher than with bosentan alone.
V stanju dinamičnega ravnovesja so bile plazemske koncentracije bosentana 3 - do 4- krat višje kot pri jemanju bosentana samega.
The blood concentrations of cyclosporine A (a CYP3A4 substrate) decreased by approximately 50%.
Koncentracije ciklosporina A (substrat CYP3A4) v krvi so se znižale za približno 50%.
Tacrolimus, sirolimus: co-administration of tacrolimus or sirolimus and Tracleer has not been studied in man but co-administration of tacrolimus or sirolimus and Tracleer may result in increased plasma concentrations of bosentan in analogy to co-administration with cyclosporine A.
Sočasne uporabe zdravila Tracleer s takrolimusom in sirolimusom pri človeku sicer niso preučili, lahko pa sočasno dajanje takrolimusa ali sirolimusa z zdravilom Tracleer povzroči povišane plazemske koncentracije bosentana po analogiji sočasnega dajanja ciklosporina A.
Concomitant Tracleer may reduce the plasma concentrations of tacrolimus and sirolimus.
Sočasno dajanje zdravila Tracleer lahko zniža plazemske koncentracije takrolimusa in sirolimusa.
Patients in need of the combination should be closely monitored for adverse events related to Tracleer and for tacrolimus and sirolimus blood concentrations.
Bolnike, ki to kombinacijo potrebujejo, je treba pazljivo opazovati zaradi neželenih dogodkov, povezanih z zdravilom Tracleer, in zaradi koncentracij takrolimusa in sirolimusa v krvi.
Glibenclamide: co-administration of Tracleer 125 mg twice daily for 5 days decreased the plasma concentrations of glibenclamide (a CYP3A4 substrate) by 40%, with potential significant decrease of the hypoglycaemic effect.
Pri sočasni uporabi zdravila Tracleer v odmerku 125 mg dvakrat na dan 5 dni se je plazemska koncentracija glibenklamida (substrat CYP3A4) znižala za 40% in potencialno pomembno zmanjšala hipoglikemični učinek.
The plasma concentrations of bosentan were also decreased by 29%.
Plazemske koncentracije bosentana so se tudi znižale za 29%.
In this context, this combination should not be used (see section 4.4).
V tem oziru te kombinacije ne smemo uporabljati (glejte poglavje 4. 4).
Warfarin: co-administration of bosentan 500 mg twice daily for 6 days decreased the plasma concentrations of both S-warfarin (a CYP2C9 substrate) and R-warfarin (a CYP3A4 substrate) by 29% and 38%, respectively.
Pri sočasni uporabi bosentana v odmerku 500 mg dvakrat na dan 6 dni se je plazemska koncentracija S- varfarina (substrat CYP2C9) znižala za 29% in plazemska koncentracija R- varfarina (substrat CYP3A4) za 38%.
Clinical experience of concomitant administration of bosentan with warfarin in patients with pulmonary arterial hypertension did not result in clinically relevant changes in International Normalized Ratio (INR) or warfarin dose (baseline versus end of the clinical studies).
Klinične izkušnje o sočasni uporabi bosentana in varfarina pri bolnikih s pljučno arterijsko hipertenzijo niso pokazale klinično pomembnih sprememb v mednarodnem normaliziranem razmerju (INR – International Normalized Ratio) ali odmerku varfarina (izhodiščna vrednost v primerjavi z vrednostjo na koncu kliničnih študij).
In addition, the frequency of changes in warfarin dose during the trials due to changes in INR or due to adverse events was similar among bosentan- and placebo-treated patients.
Poleg tega je bila med študijami pogostnost sprememb odmerka varfarina zaradi sprememb INR ali zaradi neželenih dogodkov podobna pri bolnikih, ki so jemali bosentan, in pri bolnikih, ki so prejemali placebo.
No dose adjustment is needed for warfarin and similar oral anticoagulant agents when bosentan is initiated but intensified monitoring of INR is recommended, especially during bosentan initiation and the up-titration period.
Za varfarin in podobne peroralne antikoagulante ob začetku zdravljenja z bosentanom prilagajanje odmerka ni potrebno, priporočamo pa pogostejše spremljanje INR, še zlasti med uvajanjem in višanjem odmerka bosentana.
Simvastatin: co-administration of Tracleer 125 mg twice daily for 5 days decreased the plasma concentrations of simvastatin (a CYP3A4 substrate), and its active β -hydroxy acid metabolite by 34% 7 and 46%, respectively.
Pri sočasni uporabi zdravila Tracleer v odmerku 125 mg dvakrat na dan 5 dni se je plazemska koncentracija simvastatina (substrat CYP3A4) znižala za 34%, plazemska koncentracija njegovega
Monitoring of cholesterol levels and subsequent dosage adjustment should be considered.
Upoštevamo spremljanje ravni holesterola in posledično prilagoditev odmerka.
Ketoconazole: co-administration of Tracleer 62.5 mg twice daily for 6 days and ketoconazole, a potent CYP3A4 inhibitor, increased the plasma concentrations of bosentan approximately 2-fold.
Pri sočasni uporabi zdravila Tracleer v odmerku 62, 5 mg dvakrat na dan 6 dni in ketokonazola, močnega zaviralca CYP3A4, se je plazemska koncentracija bosentana zvišala približno za dvakrat.
Although not demonstrated through in vivo studies, similar increases in bosentan plasma concentrations are expected with the other potent CYP3A4 inhibitors (such as itraconazole and ritonavir).
Čeprav študije in vivo tega niso pokazale, lahko podobno povišanje plazemske koncentracije bosentana pričakujemo tudi z drugimi močnimi zaviralci CYP3A4 (denimo, itrakonazolom in ritonavirjem).
However, when combined with a CYP3A4 inhibitor, patients who are poor metabolisers of CYP2C9 are at risk of increases in bosentan plasma concentrations that may be of higher magnitude, thus leading to potential harmful adverse events.
V kombinaciji z zaviralcem CYP3A4 obstaja pri bolnikih, ki slabo presnavljajo CYP2C9, tveganje še večjega povišanja plazemske koncentracije bosentana, kar lahko povzroči potencialno škodljive neželene dogodke.
Digoxin: co-administration of bosentan 500 mg twice daily for 7 days decreased the AUC, Cmax and Cmin of digoxin by 12%, 9% and 23%, respectively.
Pri sočasni uporabi bosentana v odmerku 500 mg dvakrat na dan 7 dni so se znižale vrednosti AUC, Cmax in Cmin za digoksin za 12%, 9% oziroma 23%.
The mechanism for this interaction may be induction of P-glycoprotein.
Mehanizem tega medsebojnega delovanja je lahko indukcija P- glikoproteina.
Epoprostenol: limited data obtained from a study (AC-052-356, BREATHE-3) in which 10 paediatric patients received the combination of Tracleer and epoprostenol indicate that after both single- and multiple-dose administration, the Cmax and AUC values of bosentan were similar in patients with or without continuous infusion of epoprostenol (see section 5.1).
Omejeni podatki, pridobljeni v študiji (AC- 052- 356, BREATHE- 3), v kateri je 10 pediatričnih bolnikov prejemalo kombinacijo zdravila Tracleer in epoprostenola, kažejo, da sta bili, tako po enkratnem kot tudi po večkratnem odmerjanju, vrednosti Cmax in AUC za bosentan podobni pri bolnikih s kontinuirno infuzijo epoprostenola ali brez nje (glejte poglavje 5. 1).
Rifampicin: co-administration in 9 healthy subjects of Tracleer 125 mg twice daily for 7 days and rifampicin, a potent inducer of CYP2C9 and CYP3A4, decreased the plasma concentrations of bosentan by 58%, and this decrease could achieve almost 90% in an individual case.
Rifampicin: sočasno dajanje zdravila Tracleer 125 mg dvakrat na dan 7 dni in rifampicina, močnega induktorja CYP2C9 in CYP3A4, 9 zdravim osebam je zmanjšalo plazemske koncentracije bosentana za 58%, v enem primeru je to zmanjšanje doseglo 90%.
A subsequent significantly reduced effect of bosentan is expected when it is co-administered with rifampicin.
Zato ob sočasnem dajanju bosentana z rifampicinom pričakujemo značilno manjši učinek bosentana.
Data on other CYP3A4 inducers, e. g. carbamazepine, phenobarbital, phenytoin and St John's wort are lacking, but their concomitant administration is expected to lead to reduced systemic exposure to bosentan.
Podatki o drugih induktorjih CYP3A4, denimo, karbamazepinu, fenobarbitalu, fenitoinu in šentjanževki, so pomanjkljivi, pričakujemo pa, da njihovo sočasno dajanje povzroči zmanjšano sistemsko izpostavljenost bosentanu.
Sildenafil: co-administration of Tracleer 125 mg twice daily (steady state) with sildenafil 80 mg three times a day (at steady state) concomitantly administered during 6 days in healthy volunteers resulted in a 63% decrease of the sildenafil AUC and a 50% increase of the bosentan AUC.
Sildenafil: šestdnevno sočasno dajanje zdravila Tracleer 125 mg dvakrat na dan (ravnovesno stanje) s sildenafilom 80 mg trikrat na dan (v ravnovesnem stanju) zdravim prostovoljcem je povzročilo 63% zmanjšanje AUC sildenafila in 50% povečanje AUC bosentana.
Caution is recommended in case of co-administration.
V primeru sočasnega dajanja je potrebna previdnost.
Studies in animals have shown reproductive toxicity (teratogenicity, embryotoxicity, see section 5.3).
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja (teratogenost, embriotoksičnost, glejte poglavje 5. 3).
There are minimal data on the use of Tracleer in pregnant women.
Na voljo je malo podatkov o uporabi zdravila Tracleer pri nosečnicah.
Tracleer is contraindicated in pregnancy (see section 4.3).
Zdravilo Tracleer je kontraindicirano (glejte poglavje 4. 3) med nosečnostjo.
Patients and prescribers must be aware that due to potential pharmacokinetic interactions, Tracleer may render hormonal contraceptives ineffective (see section 4.5).
Bolnica in zdravnik, ki zdravilo predpiše, se mora zavedati, da lahko zaradi možnih farmakokinetičnih interakcij zdravilo Tracleer povzroči neučinkovitost hormonske kontracepcije (glejte poglavje 4. 5).
Therefore, women of childbearing potential must not use hormonal contraceptives (including oral, injectable, transdermal, and implantable forms) as the sole method of contraception but must use an additional or an alternative reliable method of contraception.
Zato ženske v rodni dobi ne smejo uporabljati hormonske kontracepcije (vključno s peroralnimi, transdermalnimi oblikami, oblikami za vbrizganje in vsadki) kot edinega načina kontracepcije, temveč morajo uporabljati dodatno ali drugo zanesljivo metodo kontracepcije.
8 Use during lactation
8 Uporaba med dojenjem
It is not known whether bosentan is excreted into human milk.
Ni znano, ali se bosentan izloča v materino mleko.
No studies on the effect of Tracleer on the ability to drive and use machines have been performed.
Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
Tracleer may cause dizziness, which could influence the ability to drive or use machines.
Zdravilo Tracleer lahko povzroči omotico, ki bi lahko vplivala na sposobnost vožnje in upravljanja s stroji.
Integrated findings from placebo-controlled trials
Integrirani izsledki iz s placebom nadzorovanih študij
In eight placebo-controlled studies, six of which were for indications other than pulmonary arterial hypertension, a total of 677 patients were treated with bosentan at daily doses ranging from 100 mg to 2000 mg and 288 patients were treated with placebo.
V osmih s placebom nadzorovanih študijah, od katerih jih je bilo šest za indikacije, nepovezane s pljučno arterijsko hipertenzijo, je skupno 677 bolnikov prejemalo bosentan v dnevnem odmerku od 100 mg do 2000 mg, 288 bolnikov pa je prejemalo placebo.
The foreseen duration of treatment ranged from 2 weeks to 6 months.
Predvideno trajanje zdravljenja je bilo od 2 tednov do 6 mesecev.
The adverse drug reactions that occurred more frequently on bosentan than on placebo (≥ 3% of bosentan-treated patients, with ≥ 2% difference) were headache (15.8% vs 12.8%), flushing (6.6% vs 1.7%), abnormal hepatic function (5.9% vs 2.1%), leg oedema (4.7% vs 1.4%), and anaemia (3.4% vs 1.0%), all of which were dose related.
Neželeni učinki zdravila, ki so se pojavili bolj pogosto pri bosentanu kot pri placebu (≥ 3% bolnikov, ki so prejemali bosentan, z razliko ≥ 2%), so bili glavobol (15, 8% proti 12, 8%), rdečica obraza (6, 6% proti 1, 7%), moteno delovanje jeter (5, 9% proti 2, 1%), otekanje spodnjih okončin (4, 7% proti 1, 4%) in anemija (3, 4% proti 1, 0%), pri čemer so bili vsi neželeni učinki odvisni od odmerka.
Placebo-controlled trials in primary (idiopathic/ familial) PAH and PAH associated with connective tissue diseases
S placebom nadzorovane študije pri primarnem (idiopatskem/ družinskem) PAH in PAH, povezanem z boleznimi veziv
The table below shows the adverse drug reactions that occurred in ≥ 3% of patients treated with Tracleer (125 and 250 mg twice daily) in the phase 3 placebo-controlled trials in pulmonary arterial hypertension, and which were more frequent in these patients:
Spodnja preglednica navaja neželene učinke zdravila, ki so se pojavili pri ≥ 3% bolnikov, ki so v 3. fazi s placebom nadzorovanih študijah pljučne arterijske hipertenzije jemali zdravilo Tracleer (odmerek 125 mg in 250 mg dvakrat na dan), in ki so bili pri teh bolnikih pogostejši: