natgillin/translations-raw huggingface dataset:
In post-marketing experience with sildenafil for male erectile dysfunction, serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported in temporal association with the use of sildenafil.
V pomarketinškem obdobju so v časovni povezanosti s sildenafilom, uporabljenim za erektilno disfunkcijo pri moških, poročali o resnih kardiovaskularnih dogodkih, vključno z miokardnim infarktom, nestabilno angino pektoris, nenadno srčno smrtjo, ventrikularno aritmijo, cerebrovaskularno krvavitvijo, tranzitorno ishemično atako, hipertenzijo in hipotenzijo.
Most, but not all, of these patients had pre- existing cardiovascular risk factors.
Večina teh bolnikov (ne pa vsi) je imela že prej obstoječe kardiovaskularne dejavnike tveganja.
Sildenafil should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’ s disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
Sildenafil je treba previdno uporabljati pri bolnikih z anatomskimi deformacijami penisa (npr. z angulacijo, kavernozno fibrozo ali Peyronijevo boleznijo) in pri bolnikih z določenimi boleznimi, ki povzročajo nagnjenost k priapizmu (npr. s srpastocelično anemijo, multiplim mielomom ali levkemijo).
Visual defects and cases of non-arteritic anterior ischaemic optic neuropathy have been reported in connection with the intake of sildenafil and other PDE5 inhibitors.
V povezavi z jemanjem sildenafila in ostalih zaviralcev PDE5 so poročali o okvarah vida in o primerih nearteritične anteriorne ishemične optične nevropatije.
The patient should be advised that in case of sudden visual defect, he should stop taking Revatio and consult a physician immediately (see section 4.3).
Bolnika je treba opozoriti, da naj v primeru nenadne okvare vida preneha jemati Revatio in o tem nemudoma obvesti svojega zdravnika (glejte poglavje 4. 3).
Caution is advised when sildenafil is administered to patients taking an alpha-blocker as the co- administration may lead to symptomatic hypotension in susceptible individuals (see section 4.5).
Sildenafil je treba previdno uporabljati pri bolnikih, ki jemljejo zaviralec alfa, kajti takšna sočasna uporaba lahko pri občutljivih posameznikih povzroči simptomatsko hipotenzijo (glejte poglavje 4. 5).
In order to minimize the potential for developing postural hypotension, patients should be hemodynamically stable on alpha-blocker therapy prior to initiating sildenafil treatment.
Da bo možnost za posturalno hipotenzijo čim manjša, morajo biti bolniki, zdravljeni z zaviralcem alfa, pred uvedbo sildenafila hemodinamsko stabilni.
In pulmonary arterial hypertension patients, there may be a potential for increased risk of bleeding when sildenafil is initiated in patients already using a Vitamin K antagonist, particularly in patients with pulmonary arterial hypertension secondary to connective tissue disease.
Pri bolnikih s pljučno arterijsko hipertenzijo lahko obstaja večje tveganje za krvavitev v primeru uvedbe terapije s sildenafilom pri bolnikih, ki že uporabljajo antagonist vitamina K; to še zlasti velja za bolnike s sekundarno pljučno arterijsko hipertenzijo zaradi bolezni vezivnega tkiva.
No data are available with sildenafil in patients with pulmonary hypertension associated with pulmonary veno-occlusive disease.
4 Podatkov o sildenafilu pri bolnikih s pljučno arterijsko hipertenzijo, povezano s pljučno venookluzivno boleznijo ni.
However, cases of life threatening pulmonary oedema have been reported with vasodilators (mainly prostacyclin) when used in those patients.
So pa pri takšnih bolnikih poročali o smrtno nevarnem pljučnem edemu ob uporabi vazodilatatorjev (predvsem prostaciklina).
Consequently, should signs of pulmonary oedema occur when sildenafil is administered in patients with pulmonary hypertension, the possibility of associated veno-occlusive disease should be considered.
Če se med uporabo sildenafila pri bolnikih s pljučno hipertenzijo pojavijo znaki pljučnega edema, je zato treba pomisliti na možnost spremljajoče venookluzivne bolezni.
4 Lactose monohydrate is present in the tablet film coat.
Filmska obloga tablete vsebuje monohidrat laktoze.
Effects of other medicinal products on sildenafil In vitro studies:
Učinki drugih zdravil na sildenafil Študije in vitro:
Population pharmacokinetic analysis of pulmonary arterial hypertension clinical trial data indicated a reduction in sildenafil clearance and/ or an increase of oral bioavailability when co-administered with CYP3A4 substrates and the combination of CYP3A4 substrates and beta-blockers.
Populacijska farmakokinetična analiza podatkov iz kliničnih preskušanj pri pljučni arterijski hipertenziji je pokazala, da se očistek sildenafila zmanjša in/ ali se njegova peroralna biološka uporabnost poveča, če je uporabljen sočasno s substrati CYP3A4 ali kombinacijo substratov CYP3A4 in zaviralcev beta.
The exposure to sildenafil in patients on CYP3A4 substrates and CYP3A4 substrates plus beta-blockers was 43% and 66% higher, respectively, compared to patients not receiving these classes of medicines.
V primerjavi z bolniki, ki niso dobivali substratov CYP3A4 oz. substratov CYP3A4 in zaviralcev beta, je bila izpostavljenost sildenafilu pri prejemnikih substratov CYP3A4 večja za 43%, pri prejemnikih substratov CYP3A4 in zaviralcev beta pa za 66%.
This concentration range covers the increase in sildenafil exposure observed in specifically designed drug interaction studies with CYP3A4 inhibitors (except more potent CYP3A4 inhibitors e. g. ketoconazole, itraconazole, ritonavir).
Ta razpon koncentracij zajema povečanje izpostavljenosti sildenafilu, ki so jo opazili v specifično zasnovanih študijah interakcij z zaviralci CYP3A4 (razen močnejših zaviralcev CYP3A4, npr. ketokonazola, itrakonazola, ritonavirja).
CYP3A4 inducers seemed to have a substantial impact on the pharmacokinetics of sildenafil in pulmonary arterial hypertension patients, which was confirmed in the in-vivo interaction study with CYP3A4 inducer bosentan.
To je potrdila in vivo izvedena študija interakcij z induktorjem CYP3A4 bosentanom.
Co-administration of bosentan (a moderate inducer of CYP3A4, CYP2C9 and possibly of CYP2C19) 125mg twice daily 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 sildenafil AUC.
Sočasna uporaba bosentana (zmeren induktor CYP3A4, CYP2C9 in morda CYP2C19) v odmerku 125 mg dvakrat na dan in sildenafila v odmerku 80 mg trikrat na dan (v stanju dinamičnega ravnovesja), 6 dni pri zdravih prostovoljcih je povzročila 63% zmanjšanje AUC sildenafila.
Caution is recommended in case of co-administration.
V primeru sočasne uporabe je potrebna previdnost.
Efficacy of sildenafil should be closely monitored in patients using concomitant potent CYP3A4 inducers, such as carbamazepine, phenytoin, phenobarbital, St John’ s wort and rifamipicine.
Učinkovitost sildenafila je treba natančno nadzirati pri bolnikih, ki sočasno uporabljajo močne induktorje CYP3A4, npr. karbamazepin, fenitoin, fenobarbital, šentjanževko ali rifampicin.
Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg twice daily) with sildenafil (100 mg single dose) resulted in a 300% (4-fold) increase in sildenafil Cmax and a 1,000% (11-fold) increase in sildenafil plasma AUC.
11- kratno, povečanje AUC sildenafila v plazmi.
At 24 hours, the plasma levels of sildenafil were still approximately 200 ng/ ml, compared to approximately 5 ng/ ml when sildenafil was administered alone.
Po 24 urah je bila koncentracija sildenafila v plazmi še vedno približno 200 ng/ ml v primerjavi s približno 5 ng/ ml v primeru, ko je bil sildenafil uporabljen sam.
This is consistent with ritonavir’ s marked effects on a broad range of P450 substrates.
To se sklada z izrazitimi učinki ritonavirja na številne substrate P450.
Based on these pharmacokinetic results co-administration of sildenafil with ritonavir is contraindicated in pulmonary arterial hypertension patients (see section 4.3).
Glede na te farmakokinetične podatke je sočasna uporaba sildenafila z ritonavirjem pri bolnikih s pljučno arterijsko hipertenzijo kontraindicirana (glejte poglavje 4. 3).
Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with sildenafil (100 mg single dose) resulted in a 140% increase in sildenafil Cmax and a 210% increase in sildenafil AUC.
Sočasna uporaba zaviralca proteaz HIV sakvinavirja, ki zavira CYP3A4, v stanju dinamičnega ravnovesja (1200 mg trikrat na dan) in sildenafila (posamičen odmerek 100 mg) je povzročila 140% povečanje Cmax sildenafila in 210% povečanje AUC sildenafila.
When a single 100 mg dose of sildenafil was administered with erythromycin, a specific CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), there was a 182% increase in sildenafil systemic exposure (AUC).
5 Ob uporabi posamičnega 100- mg odmerka sildenafila hkrati z eritromicinom, specifičnim zaviralcem CYP3A4, je v stanju dinamičnega ravnovesja (500 mg dvakrat na dan 5 dni) prišlo do 182% povečanja sistemske izpostavljenosti (AUC) sildenafilu.
In normal healthy male volunteers, there was no evidence of an effect of azithromycin (500 mg daily for 3 days) on the AUC, Cmax, Tmax, elimination rate constant, or subsequent half-life of sildenafil or its principal circulating metabolite.
Pri normalnih zdravih moških prostovoljcih ni bilo opaziti učinkov azitromicina (3 dni po 500 mg na dan) na AUC, Cmax, tmax, konstanto hitrosti eliminacije ali na poznejši razpolovni čas sildenafila oz. njegovega glavnega presnovka v obtoku.
5 Potent CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have effects similar to ritonavir (see section 4.3).
Pri močnih zaviralcih CYP3A4, npr. pri ketokonazolu in itrakonazolu, bi lahko pričakovali učinke, podobne učinkom ritonavirja (glejte poglavje 4. 3).
CYP3A4 inhibitors of intermediate potency (e. g. clarithromycin, telithromycin and nefazodone) are expected to have an effect in between that of ritonavir and CYP3A4 inhibitors of medium potency (e. g. saquinavir/ erythromycin), a seven-fold increase in exposure is assumed.
Pričakovati je, da imajo izrazitejši zaviralci CYP3A4 (npr. klaritromicin, telitromicin in nefazodon) učinek, ki je med učinkom ritonavirja in učinkom srednje močnih zaviralcev CYP3A4 (npr. sakvinavirja/ eritromicina); predpostavljajo sedemkratno povečanje izpostavljenosti.
Therefore dose adjustments are recommended when using CYP3A4 inhibitors of intermediate potency (see section 4.4).
Zato je med uporabo izrazitejših zaviralcev CYP3A4 priporočljivo prilagoditi odmerek (glejte poglavje 4. 4).
The population pharmacokinetic analysis in pulmonary arterial hypertension patients suggested that co-administration of beta-blockers in combination with CYP3A4 substrates might result in an additional increase in sildenafil exposure compared with administration of CYP3A4 substrates alone.
Populacijska farmakokinetična analiza pri bolnikih s pljučno arterijsko hipertenzijo je pokazala, da lahko sočasna uporaba zaviralcev beta in substratov CYP3A4 v primerjavi z uporabo substratov CYP3A4 samih, dodatno poveča izpostavljenosti sildenafilu.
Single doses of antacid (magnesium hydroxide/ aluminium hydroxide) did not affect the bioavailability of sildenafil.
Posamični odmerki antacida (magnezijev hidroksid/ aluminijev hidroksid) niso vplivali na biološko uporabnost sildenafila.
Co-administration of oral contraceptives (ethinyloestradiol 30 μ g and levonorgestrel 150 μ g) did not affect the pharmacokinetics of sildenafil.
Sočasna uporaba peroralnih kontraceptivov (30 μg etinilestradiola in 150 μg levonorgestrela) ni vplivala na farmakokinetiko sildenafila.
Due to the nitrate component it has the potential to have serious interaction with sildenafil.
Zaradi njegove nitratne komponente obstaja možnost za močnejše interakcije s sildenafilom.
Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 > 150 μ M).
Sildenafil je šibek zaviralec izoencimov 1A2, 2C9, 2C19, 2D6, 2E1 in 3A4 citokroma P450 (IC50 > 150 μM).
No interactions were observed between sildenafil (100 mg single dose) and acenocoumarol.
Nobenih interakcij niso opazili med sildenafilom (posamičen odmerek 100 mg) in acenokumarolom.
Sildenafil (50 mg) did not potentiate the hypotensive effects of alcohol in healthy volunteers with mean maximum blood alcohol levels of 80 mg/ dl.
Sildenafil (50 mg) ni stopnjeval hipotenzivnih učinkov alkohola pri zdravih prostovoljcih, ki so imeli povprečno največjo koncentracijo alkohola v krvi 80 mg/ dl.
In a study of healthy volunteers sildenafil at steady state (80 mg three times a day) resulted in a 50% increase in bosentan AUC (125 mg twice daily).
6 V študiji zdravih prostovoljcev je sildenafil v stanju dinamičnega ravnovesja (80 mg trikrat na dan) povzročil 50% povečanje AUC bosentana (125 mg dvakrat na dan).
Caution is recommended in case of co-administration.
Ob sočasni rabi je potrebna previdnost.
6 In a specific interaction study, where sildenafil (100 mg) was co-administered with amlodipine in hypertensive patients, there was an additional reduction on supine systolic blood pressure of 8 mmHg.
V specifični interakcijski študiji, v kateri so hipertenzivni bolniki dobivali sildenafil (100 mg) sočasno z amlodipinom, se je sistolični krvni tlak v ležečem položaju dodatno znižal za 8 mmHg.
In three specific drug-drug interaction studies, the alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg, or 100 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy.
100 mg).
In these study populations, mean additional reductions of supine systolic and diastolic blood pressure of 7/ 7 mmHg, 9/ 5 mmHg, and 8/ 4 mmHg, respectively, and mean additional reductions of standing blood pressure of 6/ 6 mmHg, 11/ 4 mmHg, and 4/ 5 mmHg, respectively were observed.
8/ 4 mmHg ter dodatno znižanje krvnega tlaka v stoječem položaju za 6/ 6 mmHg, 11/ 4 mmHg in 4/ 5 mmHg.
When sildenafil and doxazosin were administered simultaneously to patients stabilized on doxazosin therapy, there were infrequent reports of patients who experienced symptomatic postural hypotension.
Ko so sildenafil in doksazosin sočasno uporabili pri bolnikih, stabiliziranih na terapiji z doksazosinom, so poročali o redkih primerih simptomatske posturalne hipotenzije.
Concomitant administration of sildenafil to patients taking alpha- blocker therapy may lead to symptomatic hypotension in susceptible individuals (see section 4.4).
Sočasna uporaba sildenafila pri bolnikih, ki dobivajo terapijo z zaviralci alfa, lahko pri občutljivih posameznikih povzroči simptomatsko hipotenzijo (glejte poglavje 4. 4).
Sildenafil (100 mg single dose) did not affect the steady state pharmacokinetics of the HIV protease inhibitor saquinavir, which is a CYP3A4 substrate/ inhibitor.
Sildenafil (v posamičnem odmerku 100 mg) ni vplival na farmakokinetiko zaviralca proteaz HIV sakvinavirja (ki je substrat/ zaviralec CYP3A4) v stanju dinamičnega ravnovesja.
Consistent with its known effects on the nitric oxide/ cGMP pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors or nitrates in any form is therefore contraindicated (see section 4.3).
S tem se sklada ugotovitev, da sildenafil okrepi hipotenzivno delovanje nitratov, zato je njegova sočasna uporaba z donorji dušikovega oksida ali nitrati v kakršnikoli obliki kontraindicirana (glejte poglavje 4. 3).
Sildenafil had no clinically significant impact on the plasma levels of oral contraceptives (ethinyloestradiol 30 μ g and levonorgestrel 150 μ g).
Sildenafil nima klinično pomembnega vpliva na koncentracijo peroralnih kontraceptivov (30 μg etinilestradiola in 150 μg levonorgestrela) v plazmi.
Studies in animals have shown toxicity with respect to postnatal development (see section 5.3).
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih vplivov na nosečnost in razvoj zarodka/ plodu, pokazale pa so toksične učinke na postnatalni razvoj (glejte poglavje 5. 3).
Due to lack of data, Revatio should not be used in pregnant women unless strictly necessary.
Zaradi pomanjkanja podatkov zdravila Revatio pri nosečnicah ne smete uporabljati, če ni nujno potrebno.
Revatio should not be administered to breast- feeding mothers.
Zdravila Revatio ne smete uporabljati pri doječih materah.
As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they might be affected by Revatio, before driving or operating machinery.
V kliničnih preskušanjih s sildenafilom so poročali o omotici in spremembah vida, zato morajo biti bolniki preden vozijo ali upravljajo s stroji, seznanjeni, kako lahko Revatio nanje vpliva.
In the pivotal placebo-controlled study of Revatio in pulmonary arterial hypertension, a total of 207 patients were treated with Revatio at daily doses ranging from 20 mg to 80 mg three times a day and 70 patients were treated with placebo.
V ključni, s placebom kontrolirani študiji zdravila Revatio za zdravljenje pljučne arterijske hipertenzije, je Revatio v dnevnih odmerkih od 20 mg do 80 mg trikrat na dan dobivalo skupno 207 bolnikov, 70 bolnikov pa je dobivalo placebo.
259 subjects who completed the pivotal study entered a long-term extension study.
259 preiskovancev, ki so dokončali to ključno študijo, je bilo vključenih v dolgoročno podaljšano študijo.
Doses up to 80 mg three times a day (4 times the recommended dose of 20 mg three times a day) were studied (N=149 patients treated for at least 1 year, 101 on 80 mg three times a day).
Vsaj eno leto je bilo zdravljenih 149 bolnikov; 101 bolnik je dobival 80 mg trikrat na dan.
The overall frequency of discontinuation in sildenafil treated patients at the recommended daily dose of 20 mg three times a day (2.9%) was low and the same as placebo (2.9%).
Skupna pogostnost prekinitev zdravljenja med bolniki, ki so dobivali sildenafil v priporočenem dnevnem odmerku 20 mg trikrat na dan (2, 9%), je bila majhna in enaka kot pri placebu (2, 9%).
7 In a placebo-controlled study of Revatio as an adjunct to intravenous epoprostenol in pulmonary arterial hypertension, a total of 134 patients were treated with Revatio (in a fixed titration starting from 20 mg, to 40 mg and then 80 mg, three times a day) and epoprostenol, and 131 patients were treated with placebo and epoprostenol.
7 V študiji, kontrolirani s placebom, v kateri so preučevali Revatio kot dodatek intravenskemu epoprostenolu pri pljučni arterijski hipertenziji, je skupno 134 bolnikov dobivalo Revatio (v fiksni titraciji najprej 20 mg, nato 40 mg in 80 mg trikrat na dan) in epoprostenol, 131 bolnikov pa placebo in epoprostenol.
The overall frequency of discontinuations in sildenafil/ epoprostenol treated patients due to adverse events was 5.2% compared to 10.7% in the placebo/ epoprostenol treated patients.
Skupna pogostnost prekinitev zaradi neželenih učinkov je bila med bolniki, ki so dobivali sildenafil/ epoprostenol, 5, 2% in pri tistih, ki so dobivali placebo/ epoprostenol, 10, 7%.
Newly reported adverse drug reactions, which occurred more frequently in the sildenafil/ epoprostenol group, were bloodshot eyes/ red eyes, blurred vision, nasal congestion, night sweats, back pain and dry mouth.
Novo opisani neželeni učinki na zdravilo, pogostejši v skupini, ki je dobivala sildenafil/ epoprostenol, so bili konjunktivalna injekcija/ rdeče oči, zamegljen vid, zamašenost nosu, nočno znojenje, bolečine v hrbtu in suha usta.
The known adverse events headache, flushing, pain in extremity and oedema were noted in a higher frequency in sildenafil/ epoprostenol treated patients compared to placebo/ epoprostenol treated patients.
Znani neželeni učinki glavobol, zardevanje, bolečine v udih in edemi so bili pogostejši pri bolnikih, ki so dobivali sildenafil/ epoprostenol, kot pri tistih, ki so dobivali placebo/ epoprostenol.
In the two-placebo controlled studies adverse events were generally mild to moderate in severity.
V teh dveh s placebom kontroliranih študijah so bili neželeni učinki na splošno blagi do zmerni.
The most commonly reported adverse reactions that occurred (greater or equal to 10%) on Revatio compared to placebo were headache, flushing, dyspepsia, diarrhoea and limb pain.
Najpogosteje opisani neželeni učinki, ki so se pojavili (več ali enako 10%) med uporabo zdravila Revatio v primerjavi s placebom, so bili glavobol, zardevanje, dispepsija, driska in bolečine v okončinah.
Adverse reactions which occurred in > 1% of Revatio-treated patients and were more frequent (> 1% difference) on Revatio in the pivotal study or in the Revatio combined data set of both the placebo- controlled studies in pulmonary arterial hypertension, at doses of 20, 40 or 80 mg three times a day are listed in the table below by class and frequency grouping (very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10), uncommon (≥ 1/ 1000, < 1/ 100) and not known (cannot be estimated from the available data).
Neželeni učinki, ki so se pojavili pri > 1% bolnikov, zdravljenih z zdravilom Revatio, ter so bili v ključni študiji oziroma v kombiniranih podatkih iz obeh s placebom kontroliranih študij pljučne arterijske hipertenzije ob odmerkih 20, 40 ali 80 mg trikrat na dan pogostejši pri jemanju zdravila (razlika > 1%), so prikazani v spodnji tabeli po organskem sistemu in pogostnosti: zelo pogosti (≥ 1/ 10), pogosti (≥1/ 100, < 1/ 10), občasni (≥1/ 1000, < 1/ 100) in ni znano (ni mogoče oceniti iz podatkov, ki so na voljo).
Reports from post-marketing experience are included in italics.
Poročila iz pomarketinških izkušenj so navedena v ležeči pisavi.
MedDRA System Organ Class Infections and infestations
MedDRA podatkovna baza glede na organske sisteme Infekcijske in parazitske bolezni
Cellulitus, influenza, sinusitis not otherwise specified (NOS)
celulitis, gripa, neopredeljen sinuzitis
Anaemia NOS
neopredeljena anemija
Metabolism and nutrition disorders Common
pogosti
Fluid retention
zastajanje tekočine
Nervous system disorders Very Common Common
Bolezni živčevja zelo pogosti pogosti
Headache Migraine NOS, tremor, paresthesia, burning sensation NOS, hypoaesthesia
glavobol neopredeljena migrena, tremor, parestezija, neopredeljen pekoč občutek, hipestezija
Retinal haemorrhage, visual disturbance NOS, blurred vision, photophobia, chromatopsia, cyanopsia, eye irritation, blood shot eyes/ red eyes
mrežnična krvavitev, neopredeljene motnje vida, zamegljen vid, fotofobija, kromatopsija, cianopsija, draženje oči, konjunktivalna injekcija/ rdeče oči
Visual acuity reduced, diplopia, abnormal sensation in eye
zmanjšanje ostrine vida, diplopija, nenormalni občutki v očesu
Ear and labyrinth disorders Common
8 Ušesne bolezni, vključno z motnjami labirinta pogosti ni znano
Not known Vascular disorders
vrtoglavica nenadna oglušelost *
Sudden deafness*
Žilne bolezni
8 Respiratory, thoracic and mediastinal disorders Common
Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti
Bronchitis NOS, epistaxis, rhinitis NOS, cough, nasal congestion
neopredeljen bronhitis, epitaksa, neopredeljen rinitis, kašelj, zamašenost nosu
Diarrhoea, dyspepsia Gastritis NOS, gastroenteritis NOS, gastrooesophageal reflux disease, haemorrhoids, abdominal distension, dry mouth
diareja, dispepsija neopredeljen gastritis, neopredeljen gastroenteritis, gastroezofagealna refluksna bolezen, hemoroidi, napenjanje v trebuhu, suha usta
Skin and subcutaneous tissue disorders Common Not known
Bolezni kože in podkožja pogosti ni znano
Alopecia, erythema, night sweats Skin rash
alopecija, eritem, nočno znojenje kožni izpuščaj
Musculoskeletal, connective tissue and bone disorders
Bolezni mišično- skeletnega sistema in vezivnega tkiva
Limb pain Myalgia, back pain
bolečine v okončinah mialgija, bolečine v hrbtu
Reproductive system and breast disorders Uncommon Not known
Motnje reprodukcije in dojk občasni ni znano