natgillin/translations-raw huggingface dataset:
Avanafil is approximately 99% bound to plasma proteins.
Približno 99 % avanafila se veže na beljakovine v plazmi.
Renal dialysis is not expected to accelerate clearance as avanafil is highly bound to plasma proteins and it is not eliminated in the urine.
Hemodializa naj ne bi pospešila izločanja, saj se avanafil močno veže na beljakovine v plazmi in se ne izloča z urinom.
• The safety of combined use of avanafil and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive medicinal products.
• na varnost sočasne uporabe avanafila in zaviralcev receptorjev alfa lahko vplivajo tudi drugi dejavniki, vključno z zmanjšanim intravaskularnim volumnom in drugimi antihipertenzivnimi zdravili.
Avanafil was shown to augment the hypotensive effects of nitrates compared to placebo in healthy subjects.
Avanafil je pri zdravih posameznikih povečal hipotenzivni učinek nitratov v primerjavi s placebom.
This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots).
To zdravilo se uporablja za zdravljenje pljučne arterijske hipertenzije (tj. povečan krvni pritisk v pljučih) in kronične tromboembolične pljučne hipertenzije (tj. povečan krvni pritisk v pljučih kot posledica zapore zaradi krvnih strdkov).
Seasonal allergy
Bolezni imunskega sistema sezonska alergija
Therefore, administration of avanafil to patients who are using any form of organic nitrate or nitric oxide donor (such as amyl nitrite) is contraindicated.
Zato je uporaba avanafila pri bolnikih, ki uporabljajo kakršno koli obliko organskega nitrata ali donorja dušikovega oksida (kot je amil-nitrit), kontraindicirana.
Patients with mild to moderate hepatic impairment (Child-Pugh class A or B) should initiate treatment with the minimum efficacious dose and adjust posology based on tolerance.
Pri bolnikih z blago do zmerno okvaro jeter (razred A ali B po Child-Pughu) je treba zdravljenje začeti z najnižjim učinkovitim odmerkom in prilagoditi odmerjanje glede na toleranco.
Studies have shown that medicinal products that inhibit CYP3A4 can increase avanafil exposure (see section 4.2).
Študije so pokazale, da lahko zdravila, ki zavirajo CYP3A4, povečajo izpostavljenost avanafilu (glejte poglavje 4.2).
• If you have a serious liver or kidney problem
• če imate resne težave z jetri ali ledvicami
• If you have chest pain (angina) or you get chest pain during sexual intercourse
• če imate bolečine v prsih (angino pektoris) ali če se te pojavijo med spolnim odnosom;
Patients who are using any form of organic nitrate or nitric oxide donors (such as amyl nitrite) (see section 4.5).
Bolniki, ki uporabljajo kakršno koli obliko organskega nitrata ali donorje dušikovega oksida (kot je amil-nitrit) (glejte poglavje 4.5).
There was no effect of a single dose of avanafil on amlodipine plasma levels.
Enkratni odmerek avanafila ni vplival na ravni amlodipina v plazmi.
• an erection that will not go away (“priapism”).
• dolgotrajna erekcija („priapizem“).
Although specific interactions of avanafil with rivaroxaban and apixaban (both CYP3A4 substrates) have not been studied, an interaction is not expected.
Čeprav specifičnega medsebojnega delovanja avanafila z rivaroksabanom in apiksabanom (oba sta substrata CYP3A4) niso proučevali, medsebojnega delovanja med temi zdravili ni pričakovati.
In phase III clinical trials no events of “hypotension” but occasional episodes of “dizziness” were observed (see section 4.8).
V kliničnih preskušanjih III. faze niso zabeležili nobenih primerov „hipotenzije“, so pa poročali o občasnih epizodah „omotice“( glejte poglavje 4.8).
The patient should be advised that in case of sudden visual effects, he should stop taking Spedra and consult a physician immediately (see section 4.3).
Bolnika je treba opozoriti, naj v primeru nenadnih motenj vida preneha uporabljati zdravilo Spedra in se takoj posvetuje z zdravnikom (glejte poglavje 4.3).
Paediatric population There is no relevant use of Spedra in the paediatric population in the indication of erectile dysfunction.
Pediatrična populacija Zdravilo Spedra ni namenjeno za uporabo pri pediatrični populaciji za indikacijo erektilne disfunkcije.
Patients with mild or moderate renal impairment (creatinine clearance ≥30 mL/min but <80 mL/min) who were enrolled in phase 3 studies showed decreased efficacy compared to those with normal renal function.
Pri bolnikih z blago do zmerno okvaro ledvic (očistek kreatinina ≥ 30 ml/min, vendar <80 ml/min), ki so bili vključeni v študije tretje faze, so opazili zmanjšano učinkovitost v primerjavi z bolniki z normalno ledvično funkcijo.
Antihypertensives other than alpha-blockers
Antihipertenzivi, ki niso zaviralci receptorjev alfa
• The other ingredients are mannitol, fumaric acid, hydroxypropylcellulose, hydroxypropylcellulose low substituted, calcium carbonate, magnesium stearate and ferric oxide yellow (E172).
• Druge sestavine zdravila so manitol, fumarna kislina, hidroksipropilceluloza, hidroksipropilceluloza, malo substituirana kalcijev karbonat, magnezijev stearat in rumeni železov oksid (E172).
Effects of other substances on avanafil
Učinki drugih zdravil na avanafil
The approximately 20,000-fold selectivity for PDE5 versus PDE3, and enzyme found in heart and blood vessels, is important because PDE3 is involved in control of cardiac contractility.
Dejstvo, da je približno 20.000-krat bolj selektiven za PDE5 kot za PDE3, tj. encim, ki se nahaja v srcu in krvnih žilah, je pomembno, ker PDE3 pomaga uravnavati krčenje srca.
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 „Uporabno do“.
Adverse reactions were similar to those seen at lower doses but incidence rates and severities were increased.
Neželeni učinki so bili podobni tistim pri manjših odmerkih, vendar so bili pogostejši in izrazitejši.
Drinking alcohol at the same time as taking Spedra may increase your heart rate and lower your blood pressure.
Uživanje alkohola sočasno z uporabo zdravila Spedra lahko poviša srčni utrip in zniža vaš krvni tlak.
The potential induction of CYP1A2, CYP2B6 and CYP3A4 by avanafil evaluated in primary human hepatocytes in vitro did not reveal any potential interaction at clinically relevant concentrations.
Morebitna indukcija izoencimov CYP1A2, 2B6 in 3A4 zaradi avanafila, ki so jo preučevali na primarnih človeških hepatocitih in vitro, ni pokazala nobenega možnega medsebojnega delovanja pri klinično pomembnih koncentracijah.
• an abnormal blood test result for creatinine, a chemical excreted in the urine, and a measure of kidney function
• nenormalni rezultati krvnih testov kreatinina, snovi, ki se izloča v urin, ter meritev ledvičnih funkcij
This increases the blood flow into your penis, helping it stay hard and erect when you get sexually excited.
Tako se poveča krvni dotok v penis, ki posledično nabrekne in otrdi, kadar ste spolno vzburjeni.
• If you have loss of vision in one eye due to not enough blood getting to your eye (non-arteritic ischemic optic neuropathy [NAION])
• če doživljate izgubo vida zaradi premajhnega dotoka krvi v oko (nearteritične ishemične optične nevropatije [NAION]);
Dose adjustments are not required in elder patients.
Pri starejših bolnikih odmerka ni treba prilagajati.
In vitro results showed for avanafil a modest potential for acting as P-gp substrate and P-gp inhibitor with digoxin as a substrate at concentrations lower than the calculated intestinal concentration.
Rezultati in vitro so pokazali, da ima avanafil nizek potencial za delovanje kot substrat P-glikoproteina in zaviralec P-glikoproteina z digoksinom kot substrat pri koncentracijah, nižjih od izračunanih koncentracij v črevesju.
Avanafil was not found to accumulate in plasma when dosed 200 mg twice daily over 7 days.
Avanafil se pri odmerjanju 200 mg dvakrat na dan v obdobju 7 dni ni kopičil v plazmi.
Based upon measurements of avanafil in semen of healthy volunteers 45-90 minutes after dosing, less than 0.0002% of the administered dose may appear in the semen of patients.
Glede na rezultate meritev avanafila v semenčicah zdravih prostovoljcev 45-90 minut po odmerjanju se lahko v semenčicah pojavi manj kot 0,0002% zaužitega odmerka.
Patients were instructed to take 1 dose of study medicinal product approximately 30 minutes prior to initiation of sexual activity.
Bolniki so morali vzeti 1 odmerek preučevanega zdravila približno 30 minut pred začetkom spolnega odnosa.
The maximum concentration and exposure was similar to that observed after subjects with normal hepatic function received an efficacious avanafil 100 mg dose.
Najvišja koncentracija in največja izpostavljenost sta bili podobni kot pri osebah z normalnim delovanjem jeter, ki so prejele učinkoviti odmerek 100 mg avanafila.
Avanafil has not been evaluated in patients with erectile dysfunction due to spinal cord injury or other neurological disorders and in subjects with severe renal or hepatic impairment.
Avanafila niso preučevali pri bolnikih z erektilno disfunkcijo, ki je posledica poškodbe hrbtenjače ali drugih nevroloških motenj, ter pri bolnikih s hudo okvaro ledvic ali jeter.
Single dose of up to 800 mg of avanafil have been given to healthy subjects and multiple daily doses up to 300 mg have been given to patients.
Zdravim osebam so dajali do 800 mg avanafila v enkratnem odmerku, bolnikom pa do 300 mg v večkratnih dnevnih odmerkih.
Dose adjustments can also be required if Spedra is used together with certain other medicines.
Odmerek je včasih treba prilagoditi tudi zaradi sočasne uporabe zdravila Spedra z nekaterimi drugimi zdravili.
A total of 1774patients received avanafil, which was taken as needed at doses of 50 mg (one study), 100 mg and 200 mg (four studies), respectively.
Avanafil je prejemalo skupno 1.774 bolnikov, ki so ga jemali v odmerkih po 50 mg (ena študija) oziroma 100 mg in 200 mg (štiri študije).
• penile disorder
• motnje penisa
As dizziness and altered vision were reported in clinical trials with avanafil, patients should be aware of how they react to Spedra before driving or using machines.
Ker so v kliničnih študijah poročali o omoticah in spremembah vida, morajo bolniki pred vožnjo ali upravljanjem strojev vedeti, kako zdravilo Spedra vpliva nanje.
When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by avanafil produces increased levels of cGMP in the corpus cavernosum of the penis.
Ko spolno vzburjenje sproži lokalno sproščanje dušikovega oksida, se zaradi zaviralnih učinkov avanafila na PDE5 povišajo ravni cGMP v kavernoznem tkivu penisa.
Although specific interactions have not been studied, other CYP3A4 inhibitors, including grapefruit juice would likely increase avanafil exposure.
Čeprav specifičnega medsebojnega delovanja niso preučevali, obstaja verjetnost, da bi tudi drugi zaviralci CYP3A4, med drugim grenivkin sok, povečali izpostavljenost avanafilu.
Adverse reaction (MedDRA Preferred Term) System Organ Class Common
Neželeni učinek (navedba po MedDRA) Organski sistem Pogosti
Further, the metabolites of avanafil (M4, M16 and M27), also demonstrated a minimal inhibition of CYPs 1A1/2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4.
Presnovki avanafila (M4, M16 in M27) so prav tako minimalno zavirali izoencime CYP 1A1/2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 in 3A4.
These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors.
O tovrstnih dogodkih, ki jih lahko spremljata tinitus in omotica, so poročali v časovni povezavi z jemanjem zaviralcev PDE5.
Since the in vitro data identified potential avanafil interactions with CYPs 2C19, 2C8/9, 2D6 and 3A4, further clinical studies using omeprazole, rosiglitazone and desipramine did not reveal clinically relevant interactions with CYPs 2C19, 2C8/9 and 2D6.
Ker so podatki, pridobljeni in vitro, pokazali, da obstaja možnost medsebojnega delovanja avanafila z izoencimi CYP 2C19, 2C8/9, 2D6 in 3A4, nadaljnje klinične študije z uporabo omeprazola, rosiglitazona in dezipramina niso pokazale klinično pomembnih medsebojnih delovanj z izoencimi CYP 2C19, 2C8/9 in 2D6.
After oral administration, avanafil is excreted as metabolites predominantly in the faeces (approximately 63% of administered oral dose) and to a lesser extent in the urine (approximately 21% of the administered oral dose).
Po peroralni uporabi se avanafil v obliki presnovka pretežno izloči z blatom (približno 63% peroralnega odmerka) ter v manjšem obsegu z urinom (približno 21% peroralnega odmerka).
In in vitro studies in human liver microsomes, avanafil showed a negligible potential for drug-drug interactions with CYP1A1/2, 2A6, 2B6 and 2E1.
V študijah in vitro na mikrosomih človeških jeter je avanafil pokazal, da obstaja zanemarljiva možnost medsebojnega delovanja avanafila z izoencimi CYP1A1/2, 2A6, 2B6 in 2E1.
NAME OF THE MARKETING AUTHORISATION HOLDER Menarini Luxembourg
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Menarini Luxembourg
• In those patients already taking an optimised dose of Spedra, alpha-blocker therapy should be initiated at the lowest dose.
• pri bolnikih, ki že jemljejo optimalni odmerek zdravila Spedra, je treba zdravljenje z zaviralci receptorjev alfa začeti z najmanjšim odmerkom.
Grapefruit juice can increase exposure to the medicine and should be avoided within 24 hours prior to taking Spedra.
Grenivkin sok lahko poveča izpostavljenost zdravilu, zato se morate uživanju grenivkinega soka izogibati 24 ur pred jemanjem zdravila Spedra.
A clinical study was conducted to assess the effect of avanafil on the potentiation of the blood pressure-lowering effects of selected antihypertensive medicinal products (amlodipine and enalapril).
Izvedena je bila klinična študija za oceno učinka avanafila na povečanje učinkov nekaterih antihipertenzivnih zdravil (amlodipina in enalaprila) na zniževanje krvnega tlaka.
Avanafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 4.5), and as such potentiates the hypotensive effect of nitrates (see section 4.3).
Avanafil ima vazodilatatorne lastnosti, kar pomeni, da povzroča rahlo in prehodno znižanje krvnega tlaka (glejte poglavje 4.5), s čimer poveča hipotenzivni učinek nitratov (glejte poglavje 4.3).
In subjects with mild (creatinine clearance ≥ 50 - < 80 mL/min) and moderate (creatinine clearance ≥ 30 - < 50 mL/min) renal impairment, the pharmacokinetics of a single 200 mg dose of avanafil were not altered.
Pri osebah z blago (očistek kreatinina  50-< 80 ml/min) in zmerno (očistek kreatinina  30< 50 ml/min) okvaro ledvic se farmakokinetika enkratnega odmerka 200 mg avanafila ni spremenila.
In all trials, statistically significant improvement in all primary efficacy measures were observed for all three doses of avanafil compared to placebo.
V vseh preskušanjih so pri vseh treh odmerkih avanafila opazili statistično pomembno izboljšanje v primerjavi s placebom po vseh primarnih merilih učinkovitosti.
• raised liver enzymes
• povišani jetrni encimi
In particular, tell your doctor and do not take Spedra if you are taking “nitrate” medicines for chest pain (angina) such as amyl nitrite or glyceryl trinitrate.
Še zlasti morate obvestiti svojega zdravnika in ne smete vzeti zdravila Spedra, če jemljete „nitrate“ proti bolečinam v prsih (angini pektoris), kot je amil-nitrit ali gliceriltrinitrat.
• If you have any bleeding disorder or active peptic ulceration.
• če imate motnje strjevanja krvi ali aktivno razjedo želodca.
The safety and efficacy of combinations of avanafil and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied (see section 4.4).
Varnost in učinkovitost avanafila v kombinaciji z drugimi zaviralci PDE5 ali drugimi zdravili za erektilno disfunkcijo nista bili preučeni (glejte poglavje 4.4).
If you have any further questions on the use of Spedra, ask your doctor or pharmacist.
Če imate kakršna koli dodatna vprašanja o uporabi zdravila Spedra, se posvetujte z zdravnikom ali farmacevtom.
• an abnormal blood test result for a prostate test called ‘PSA'
• nenormalni rezultati krvnih testov prostate ‘PSA'
• other medicines that may reduce the breakdown of Spedra in the body (‘moderate CYP3A4
• druga zdravila, ki lahko zavirajo razgradnjo zdravila Spedra v telesu („srednje močne zaviralce
Consumption of alcohol in combination with avanafil can increase the potential for symptomatic hypotension (see section 4.5).
Uživanje alkohola v kombinaciji z avanafilom lahko poveča možnosti za simptomatsko hipotenzijo (glejte poglavje 4.5).
In a single-dose three-way crossover design study evaluating healthy subjects, the mean maximum reduction in diastolic blood pressure was significantly greater following avanafil administered in combination with alcohol than following avanafil alone (3.2 mmHg) or alcohol alone (5.0 mmHg) (see section 4.4).
V trismerni navzkrižni študiji z enkratnim odmerkom, v katero so bile vključene zdrave osebe, je bilo povprečno največje znižanje diastoličnega krvnega tlaka znatno večje po uporabi avanafila v kombinaciji z alkoholom kot po uporabi samo avanafila (3,2 mmHg) ali samo alkohola (5,0 mmHg) (glejte poglavje 4.4).
In vitro studies with human platelets indicate that PDE5 inhibitors do not have an effect on platelet aggregation on their own, but at supratherapeutic doses they potentiate the anti-aggregatory effect of the nitric oxide donor sodium nitroprusside.
Študije in vitro s človeškimi trombociti kažejo, da zaviralci PDE5 sami nimajo učinka na agregacijo trombocitov, vendar pa v odmerkih, višjih od terapevtskih odmerkov, povečujejo protiagregacijski učinek natrijevega nitroprusida kot donorja dušikovega oksida.
Patients with known hereditary degenerative retinal disorders.
Bolniki z znanimi dednimi degenerativnimi boleznimi mrežnice.
Angina pectoris Tachycardia
Srčne bolezni palpitacije angina pektoris tahikardija
What Spedra looks like and contents of the pack
Izgled zdravila Spedra in vsebina pakiranja
In such circumstances, nitrates should still only be administered under close medical supervision with appropriate haemodynamic monitoring (see section 4.3).
V opisanih okoliščinah se lahko nitrate uporabi izključno pod strogim zdravniškim nadzorom, ki vključuje ustrezno spremljanje hemodinamskih sprememb (glejte poglavje 4.3).
If Spedra is used in combination with another medicinal product which reduces systemic blood pressure, the additive effects may result in symptomatic hypotension (e.g. dizziness, light-headedness, syncope or near-syncope).
Pri sočasni uporabi zdravila Spedra z drugim zdravilom, ki znižuje sistemski krvni tlak, lahko aditivni učinki povzročijo simptomatsko hipotenzijo (npr. omotico, vrtoglavico, izgubo zavesti ali skorajšnjo izgubo zavesti).
• premature ejaculation
• prezgodnja ejakulacija
The plasma concentrations of the major circulating metabolites, M4 and M16, are approximately 23% and 29% that of the parent compound, respectively.
Koncentraciji glavnih presnovkov v plazmi, M4 oziroma M16, sta približno 23% oziroma 29% koncentracije izhodne spojine.
There are no data from the use of avanafil in pregnant women.
Podatkov o uporabi avanafila pri nosečnicah ni.
This can happen in men with conditions like sickle cell disease, multiple myeloma or leukaemia.
(Ta se lahko pojavi pri moških z boleznimi, kot so bolezen srpastih celic, multiplim mielomom ali levkemijo);
Avanafil had no effect on the pharmacokinetics of amlodipine, but amlodipine increased the maximum and total exposure of avanafil by 28% and 60%, respectively (see section 4.4).
Avanafil ni vplival na farmakokinetiko amlodipina, je pa amlodipin povečal največjo oziroma skupno izpostavljenost avanafilu za 28% oziroma 60% (glejte poglavje 4.4).
Protein binding is independent of total active substance concentrations, age, renal and hepatic function.
Vezava je neodvisna od celokupnih koncentracij zdravilne učinkovine, starosti ter delovanja ledvic in jeter.
• an abnormal blood test result for bilirubin, a chemical produced from the normal breakdown of red blood cells
• nenormalni rezultati krvnih testov bilirubina, snovi, ki nastaja ob nenormalni razgradnji rdečih krvničk
Spedra contains the active substance avanafil.
Zdravilo Spedra vsebuje zdravilno učinkovino avanafil.
Effects of avanafil on other medicinal products
Učinki avanafila na druga zdravila
In humans, PDE5 inhibitors do not appear to affect bleeding time alone or in combination with acetylsalicylic acid.
Pri ljudeh naj zaviralci PDE5 niti sami niti v kombinaciji z acetilsalicilno kislino ne bi vplivali na čas krvavitev.
At a maternally toxic dose of 1000 mg/kg/day (approximately 49 times the MRHD on a mg/m basis), decreased fetal body weight occurred with no signs of teratogenicity.
Pri maternalno toksičnem odmerku 1.000 mg/kg/dan (približno 49-krat večjem odmerku od MRHD na podlagi mg/m2), so zabeležili manjšo telesno maso plodov brez znakov teratogenosti.
Concomitant use of other treatments for erectile dysfunction The safety and efficacy of combinations of Spedra and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied.
Sočasna uporaba drugih zdravljenj erektilne disfunkcije Varnost in učinkovitost zdravila Spedra v kombinaciji z drugimi zaviralci PDE5 ali drugimi zdravili za zdravljenje erektilne disfunkcije nista bili preučeni.
It is eliminated predominantly by hepatic metabolism (mainly CYP3A4).
Izloča se predvsem s presnovo v jetrih (večinoma s CYP3A4).
PDE5 inhibitors have been shown to increase the hypotensive effects of this medicine.
Pokazalo se je, da PDE5 zaviralci povečajo hipotenziven učinek teh zdravil.
Across all of the pivotal trials of avanafil, the percentage of successful intercourse attempts was significantly higher for all doses of avanafil compared to placebo for attempts at all post-dosing time intervals examined.
V vseh ključnih preskušanjih avanafila je bil odstotek poskusov, ki so se končali z uspešnim spolnim odnosom, pri vseh odmerkih avanafila znatno višji kot pri placebu v vseh preučevanih časovnih intervalih po odmerjanju.
• pain or discomfort in the lower abdomen
• bolečina ali neugodje v spodnjem delu trebuha
Also do not take Spedra if you are taking medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir or if you are taking medicines for fungal infections such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin (see beginning of section 2 under ‘Do not take Spedra').
Zdravila Spedra tudi ne smete vzeti, če jemljete zdravila za zdravljenje okužbe z virusom HIV ali aidsom, kot so ritonavir, indinavir, sakvinavir, nelfinavir ali atazanavir, ali če jemljete zdravila proti glivičnim okužbam, npr. ketokonazol, itrakonazol ali vorikonazol, ali določene antibiotike proti bakterijskim okužbam, npr. klaritromicin ali telitromicin (glejte začetek poglavja 2 pod naslovom “Ne jemljite zdravila Spedra”).
Overall adverse events and adverse reactions for avanafil-treated subjects were more frequent in subjects with a Body Mass Index (BMI) <25 (normal BMI subjects).
Splošni neželeni dogodki in neželeni učinki so bili pogostejši pri posameznikih z indeksom telesne mase (ITM) < 25 (posameznikih z normalnim ITM).
Penis disorder Spontaneous penile erection
Motnje reprodukcije in dojk motnje penisa spontana erekcija penisa genitalni pruritus
Patients with severe renal impairment (creatinine clearance < 30 mL/min).
Bolniki s hudo okvaro ledvic (očistek kreatinina < 30 ml/min).