natgillin/translations-raw huggingface dataset:
§ Further to the assessment of the data on serious skin reactions, celecoxib is associated with very rare occurrence of serious skin reactions, as evidenced in clinical studies and post marketing surveillance, which analysis revealed several risk factors for the occurrence of theseserious skin reactions with celecoxib. 
§ Po vrednotenju podatkov o hudih kožnih reakcijah je celekoksib povezan z zelo redkimi pojavi hudih kožnih reakcij, kot je razvidno iz klinicnih študij in postmarketinškega nadzora, katerih analiza je pokazala vec dejavnikov tveganja za pojav hudih kožnih reakcij s celekoksibom.
For the primary endpoint complicated ulcers (defined as gastrointestinal bleeding, perforation or obstruction) celecoxib was not significantly different than either ibuprofen or diclofenac individually. 
Glede primarne koncne tocke, ki so jo predstavljali zapleteni ulkusi (opredeljeni kot gastrointestinalna krvavitev, predrtje ali zapora), se celekoksib ni znacilno razlikoval ne od ibuprofena ne od diklofenaka.
If a woman becomes pregnant during treatment, celecoxib should be discontinued. 
Ce ženska med zdravljenjem zanosi, je treba uporabo celekoksiba prekiniti.
Although it is not a strong inhibitor of this enzyme, a dose reduction may be necessary for individually dose-titrated drugs that are metabolised by CYP2D6 (See 4.5). 
Ceprav ni mocan zaviralec tega encima, utegne biti potrebno znižanje odmerka individualno titriranih zdravil, ki se presnavljajo s CYP2D6 (glejte poglavje 4.5).
The data were inconsistent in comparison with diclofenac (150 mg per day). 
V primerjavi z diklofenakom (150 mg na dan) so bili podatki nekonsistentni.
Very rare: myositis 
Zelo redki: miozitis
Further to discussions at the CHMP October 2004 plenary meeting, the European Commission recommended that this public health issue on all aspects of cardiovascular safety including thrombotic events and cardio-renal events is the subject of Community referrals under Article 31 of Directive 2001/83/EC, as amended regarding decentrally authorised products containing celecoxib, etoricoxib and lumiracoxib and subject to a review procedure under Article 18 of Council Regulation (EEC) No 2309/93, as amended regarding the centrally authorised products containing celecoxib (Onsenal), parecoxib (Dynastat/Rayzon) and valdecoxib (Bextra/Valdyn), which were started in November 2004. 
V zvezi z razpravo Odbora za zdravila za uporabo v humani medicini (CHMP) na plenarni seji oktobra 2004 je Evropska komisija priporocila, da se za to javno zdravstveno vprašanje o vseh vidikih kardiovaskularne varnosti, vkljucno s tromboticnimi dogodki in kardiorenalnimi dogodki, sproži napotitveni postopek Skupnosti v skladu z 31. clenom Direktive 2001/83/ES z vsemi dodatki za zdravila, odobrena po decentraliziranem postopku, in vsebujejo celekoksib, etorikoksib in lumirakoksib ter revizijski postopek v skladu z 18. clenom Uredbe Sveta (EGS) št. 2309/93 z vsemi dodatki za zdravila, odobrena po centraliziranem postopku, in vsebujejo celekoksib (Onsenal), parekoksib (Dynastat/Rayzon) in valdekoksib (Bextra/Valdyn).
In September 2004, the Marketing Authorisation Holder (MAH) of rofecoxib (a selective Cox-2inhibitor) informed the EMEA that new clinical trial (APPROVe) data for rofecoxib have revealed a risk of thrombotic cardiovascular (CV) events. 
Septembra 2004 je imetnik dovoljenja za promet z rofekoksibom (selektivnim zaviralcem Cox-2) obvestil Evropsko agencijo za zdravila, da so podatki iz novega klinicnega preizkušanja (APPROVe) rofekoksiba pokazali tveganje za tromboticne kardiovaskularne dogodke.
The phase I metabolism is mainly catalysed by CYP2C9. 
Prvo fazo presnove katalizira predvsem CYP2C9.
The MAH commits to performing a global CV study to confirm long term CV safety of Celecoxib. 
Imetnik dovoljenja za promet se zavezuje, da bo izvedel globalno kardiovaskularno študijo za potrditev dolgorocne kardiovaskularne varnosti celekoksiba.
{Invented Name}100 mg and 200 mg capsules contain lactose (149.7 mg and 49.8 mg, respectively). 
Trde kapsule {izmišljeno ime} a 100 mg oz. 200 mg vsebujejo laktozo (149,7 mg oz. 49,8 mg).
The dose may, if needed, later be increased to 200 mg twice daily. 
Ce je potrebno, se odmerek kasneje poveca na 200 mg dvakrat na dan.
There is a genetic polymorphism of this enzyme. 
Ta encim kaže genetski polimorfizem.
Examples of drugs which are metabolised by CYP2C19 are diazepam, citalopram and imipramine. 
Zgledi zdravil, ki se presnavljajo s CYP2C19, so diazepam, citalopram in imipramin.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine. 
Bolniki z redkimi prirojenimi motnjami, kot so galaktozna intoleranca, laponska oblika zmanjšane aktivnosti laktaze ali malabsorbcija laktoze, ne smejo jemati tega zdravila.
Ongoing Clinical Trials: Preliminary safety information from three long-term studies involving patients with Sporadic Adenomatous Polyps or who were predisposed to developing Alzheimer's disease treated with celecoxib is available. 
Klinicne študije, ki še potekajo: na voljo so preliminarne varnostne informacije iz treh dolgorocnih študij, ki so zajele bolnike s sporadicnimi adenomatoznimi polipi in bolnike s predispozicijo za Alzheimerjevo bolezen, zdravljene s celekoksibom.
The pharmacokinetics of celecoxib has not been studied in patients with renal impairment but is unlikely to be markedly changed in these patients. 
Farmakokinetika celekoksiba pri bolnikih z okvaro jeter ni raziskana, vendar ni verjetno, da bi bila izrazito spremenjena.
COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and central nervous system functions (fever induction, pain perception and cognitive function). 
COX-2 je vpletena tudi v ovulacijo, ugnezdenje zarodka in zaprtje arterioznega duktusa, uravnavanje delovanja ledvic in delovanje osrednjega živcevja (indukcija zvišane telesne temperature, zaznavanje bolecine in kognitivno funkcioniranje).
Therefore, patients receiving oral anticoagulants should be closely monitored for their prothrombin time INR, particularly in the first few days when therapy with celecoxib is initiated or the dose of celecoxib is changed (see 4.4). 
Zato je treba pri bolnikih, ki dobivajo peroralne antikoagulanse, natancno spremljati protrombinski cas INR, zlasti v prvih dneh po zacetku zdravljenja ali spremembi odmerka celekoksiba (glejte poglavje 4.4).
Investigations Uncommon: increased SGOT and SGPT, increased creatinine, BUN increased 
Preiskave Obcasni: zvišanje SGOT in SGPT, zvišanje kreatinina, zvišanje secnine
Severe renal impairment is contraindicated. 
Huda okvara ledvic je kontraindikacija.
Active peptic ulceration or gastrointestinal (GI) bleeding. 
Aktiven pepticni ulkus ali krvavitev iz gastrointestinalnega trakta.
Pfizer AB Nytorpsvägen 36 P.O. 
Pfizer AB Nytorpsvägen 36 P.O. Box 501
Inflammatory bowel disease. 
Vnetna crevesna bolezen.
Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis. 
Simptomatsko zdravljenje osteoartroze ali revmatoidnega artritisa.
Celecoxib can be used with low-dose acetylsalicylic acid but is not a substitute for acetylsalicylic acid for cardiovascular prophylaxis. 
Celekoksib se lahko uporablja z majhnimi odmerki acetilsalicilne kisline, vendar ni nadomestilo za acetilsalicilno kislino v kardiovaskularni profilaksi.
SCIENTIFIC CONCLUSIONS FOR THE AMENDMENT OF THE MARKETING AUTHORISATION 
ZNANSTVENI ZAKLJUCKI ZA DOPOLNILO DOVOLJENJA ZA PROMET
COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established. 
COX-2 so pri cloveku našli v tkivu okoli želodcnih ulkusov, a njena vloga pri celjenju ulkusov ni ugotovljena.
Approximately 7400 patients were treated with celecoxib in controlled trials and of those approximately 2300 have received it for 1 year or longer. 
V kontroliranih preskušanjih je celekoksib dobivalo približno 7.400 bolnikov; približno 2.300 od teh ga je dobivalo 1 leto ali vec.
The absolute risk for the composite endpoint was 3.0% for the higher dose of celecoxib, 2.2% for the lower dose of celecoxib, and 0.9% for placebo. 
Absolutno tveganje za sestavljen opazovani dogodek je bilo 3,0 % pri višjem odmerku celekoksiba, 2,2 % pri manjšem odmerku celekoksiba in 0,9 % pri placebu.
- Addition of brief information of the CV findings in PreSAP (Efficacy and safety of celecoxib (SC-58635) in the prevention of colorectal sporadic adenomatous polyps) and APC (Prevention of sporadic colorectal adenomas with celecoxib); to include more stringent wording regarding CV risk groups. 
- dodana je kratka informacija o kardiovaskularnih izsledkih v PreSAP (Ucinkovitost in varnost celekoksiba (SC-58635) pri preprecevanju posameznih kolorektalnih adenomnih polipov) in APC (Preprecevanje posameznih kolorektalnih adenomov s celekoksibom); vkljuciti strožje besedilo v zvezi s skupinami za kardiovaskularna tveganja.
6.6 Instructions for use and handling, and disposal (if appropriate) No special requirements. 
6.6 Navodila za pripravo in ravnanje z zdravilom Ni posebnih zahtev.
The main metabolites found in the circulation have no detectable COX-1 or COX-2 activity. 
Glavni presnovki v obtoku ne delujejo zaznavno na COX-1 ali COX-2.
The changes of the Product Information related to the SCAR can be summarised as follows: - Addition of a warning to report that the onset of skin reactions occur in the majority of cases within the first month of treatment. 
Spremembe informacij o zdravilu, povezanih s hudimi kožnimi neželenimi reakcijami (Severe Cutaneous Adverse Reaction, SCAR), lahko povzamemo, kot sledi: - dodano je opozorilo k porocilu, da se kožne reakcije v vecini primerov pojavijo v prvem mesecu zdravljenja.
Whereas, the CHMP - is of the Opinion that the benefit/risk balance of medicinal products containing celecoxib in the agreed indications remains favourable and the Marketing Authorisations should be maintained according to revised Summaries of Product Characteristics (attached in Annex III of the CHMP Opinion), - concluded that the cardiovascular safety and serious skin reactions should be continuously and carefully monitored and assessed, - recommended to initiate a long term study to investigate the safety of celecoxib relative to non selective NSAIDs. 
Ob upoštevanju, da je CHMP - mnenja, da razmerje med koristjo in tveganjem za zdravila, ki vsebujejo celekoksib za dogovorjene indikacije, ostaja ugodno in da se dovoljenja za promet ohranijo v skladu s popravljenimi Povzetki glavnih znacilnosti zdravil (priloženih mnenju CHMP v Dodatku III), - zakljucil, da je treba kardiovaskularno varnost in hude kožne reakcije neprekinjeno in natancno spremljati in vrednotiti, - priporocil lansiranje dolgorocne študije, ki bi raziskovala varnost celekoksiba v primerjavi z neselektivnimi nesteroidnimi protivnetnimi zdravili, - priporocil nadaljnje ukrepe za dodatno raziskovanje varnosti celekoksiba.
Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease. 
Potrjena ishemicna bolezen srca, bolezen perifernih arterij in/ali cerebrovaskularna bolezen
Also for the combined NSAID group there was no statically significant difference for complicated ulcers (relative risk 0,77, 95 % CI 0.41-1.46, based on entire study duration). 
Tudi v primerjavi s kombinirano skupino nesteroidnih antirevmatikov glede zapletenih ulkusov ni bilo statisticno znacilne razlike (relativno tveganje 0,77, 95 % IZ 0,41-1,46, na podlagi celotnega trajanja študije).
To continue to report all ADR frequencies, based on the adverse reaction profile derived from placebo controlled studies, particularly the long-term studies as well as other post marketing experience and make changes to the SPC in accordance with standard Pharmacovigilance reporting and procedures (PSUR, Type II variation within MRP). 
Da bo nadaljeval s porocanjem vseh pojavov neželenih ucinkov zdravila na podlagi profila o neželenih ucinkih iz s placebom kontroliranih študij, zlasti dolgorocnih, kot tudi iz drugih postmarketinških izkušenj, in da bo spremenil SPC v skladu s standardnim porocanjem o farmakovigilanci in postopki farmakovigilance (PSUR, variacije tipa II v okviru postopka medsebojnega priznavanja).
Very rare: angioedema, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, epidermal necrolysis, 
Zelo redki: angioedem, eksfoliacijski dermatitis, multiformni eritem, Stevens-Johnsonov sindrom, epidermalna nekroliza in multiformni eritem
Capsule shells contain gelatin, titanium dioxide E171; ink contains iron oxide E172. 
Ovojnica kapsul vsebuje želatino in titanov dioksid E171, crnilo vsebuje železov oksid E172.
After the Commission Decision, the Member State competent authorities will update the product information as required. 
Pristojne oblasti držav clanic bodo podatke o izdelku posodobile v skladu z zahtevami, ko bo podana odlocba Komisije.
Pharmacia Ltd. Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom 
Pharmacia Ltd. Ramsgate Road Sandwich Kent CT13 9NJ Velika Britanija
Uncommon: anxiety, depression, tiredness Very rare: confusion, hallucinations. 
Obcasni: anksioznost, depresija, utrujenost Zelo redki: zmedenost, halucinacije
Celecoxib has been shown to cause malformations in the two animal species studied (See 4.6 and 5.3). 
Pokazalo se je, da celekoksib povzroca malformacije ploda pri dveh testiranih živalskih vrstah (glejte poglavji 4.6 in 5.3).
Patients who experience dizziness, vertigo or somnolence while taking celecoxib should refrain from driving or operating machinery. 
Bolniki, ki med jemanjem celekoksiba doživljajo omotico, vrtoglavico ali zaspanost, ne smejo voziti ali upravljati strojev.
In animals, exposure to celecoxib during early embryonic development resulted in pre-implantation and post-implantation losses. 
Pri živalih je izpostavljenost celekoksibu v casu zgodnjega embrionalnega razvoja povzrocila splav pred ugnezditvijo in po ugnezditvi.
However, in healthy subjects, in small multiple dose studies with 600 mg BID (three times the highest recommended dose) celecoxib had no effect on platelet aggregation and bleeding time compared to placebo. 
Vendar pri zdravih preiskovancih v majhnih študijah z vec odmerki 600 mg (trikratni najvecji priporoceni odmerek) dvakrat na dan celekoksib ni vplival na agregacijo trombocitov in cas krvavitve v primerjavi s placebom.
Patients known to be CYP2C9 poor metabolisers should be treated with caution (see 5.2. 
Bolnike, ki so slabi metabolizatorji s CYP2C9, je treba zdraviti previdno (glejte poglavje 5.2).
Ramsgate Road Sandwich Kent CT13 9NJ England 
Ramsgate Road Sandwich Kent CT13 9NJ Velika Britanija
Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with celecoxib after careful consideration (see 5.1). 
Bolnike s pomembnimi dejavniki tveganja srcnožilnih dogodkov (npr. visok krvni tlak, hiperlipidemija, sladkorna bolezen, kajenje) lahko s celekoksibom zdravimo le po skrbnem premisleku (glejte poglavje
ANNEX III SUMMARY OF THE PRODUCT CHARACTERISTICS Note: This SPC is the one that was Annexed to the Commission Decision on this Article 31 referral for celecoxib containing medicinal products. 
Opomba: Ta Povzetek glavnih znacilnosti zdravila je bil priložen k odlocbi Komisije v zvezi s tem postopkom, ki je bil sprožen v skladu s clenom 31, za zdravila, ki vsebujejo celekoksib.
The difference in antiplatelet activity between some COX-1 inhibiting NSAIDs and COX-2 selective inhibitors may be of clinical significance in patients at risk of thrombo-embolic reactions. 
Razlika v antitrombocitni aktivnosti med nekaterimi nesteroidnimi antirevmatiki, ki zavirajo COX-1, in selektivnimi zaviralci COX-2 bi lahko bila klinicno pomembna pri bolnikih, ki jih ogrožajo trombembolicne reakcije.
In patients with rheumatoid arthritis celecoxib had no statistically significant effect on the pharmacokinetics (plasma or renal clearance) of methotrexate (in rheumatologic doses). 
Pri bolnikih z revmatoidnim artritisom celekoksib ni statisticno znacilno vplival na farmakokinetiko (plazemski ali ledvicni ocistek) metotreksata (v revmatoloških odmerkih).
- Addition of the contraindications Established ischaemic heart disease and/or cerebrovascular disease and Peripheral arterial disease. 
- dodani sta kontraindikaciji Potrjena ishemicna srcna bolezen in/ali cerebrovaskularno obolenje ter Periferna arterijska bolezen.
In an interaction study, celecoxib had no clinically relevant effects on the pharmacokinetics of oral contraceptives (1 mg norethistherone /35 microg ethinylestradiol). 
V študiji medsebojnega delovanja celekoksib ni klinicno pomembno vplival na farmakokinetiko peroralnih kontraceptivov (1 mg noretisterona/35 mikrogramov etinilestradiola).
Examples of drugs which are metabolised by CYP2D6 are antidepressants (tricyclics and SSRIs), neuroleptics, antiarrhythmic drugs, etc. 
Zgledi zdravil, ki se presnavljajo s CYP2D6, so antidepresivi (triciklicni in zaviralci sprejema serotonina), nevroleptiki, antiaritmiki itn.
Celecoxib is contraindicated in pregnancy and in women who can become pregnant (see 4.3 and 4.4). 
Celekoksib je kontraindiciran pri nosecnicah in ženskah, ki bi lahko zanosile (glejte poglavji 4.3 in 4.4).
Ketoconazole or antacids have not been observed to affect the pharmacokinetics of celecoxib. 
Za ketokonazol in antacide ni ugotovljeno, da bi vplivali na farmakokinetiko celekoksiba.
Patients with severe hepatic impairment (serum albumin <25 g/l) have not been studied and celecoxib is contraindicated in this patient group. 
Študij pri bolnikih s hudo okvaro jeter (albumin v serumu < 25 g/l) ni bilo in pri teh bolnikih je celekoksib kontraindiciran.
As for NSAIDs, the risk of acute renal insufficiency, which is usually reversible, may be increased in some patients with compromised renal function (e.g. dehydrated patients or elderly patients)when ACE inhibitors or angiotensin II receptor antagonists are combined with NSAIDs, including celecoxib. 
Za NSAID-e velja, da se tveganje akutne ledvicne insuficience, ki je obicajnoreverzibilna, lahko pri nekaterih bolnikih s prizadeto funkcijo ledvic (npr. dehidrirani ali starejši bolniki) poveca v primeru, da kombiniramo zaviralce ACE ali antagoniste receptorjev angiotenzina II z NSAID-i, vkljucno s celekoksibom.
COX-2 is the isoform of the enzyme that has been shown to be induced by proinflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. 
COX-2 je tista izooblika encima, ki jo dokazano inducirajo provnetni dražljaji in naj bi bila predvsem odgovorna za sintezo prostanoidnih mediatorjev bolecin, vnetja in zvišane telesne temperature.
The significantly lower incidence of this event with celecoxib was maintained with or without acetylsalicylic acid use. 
Incidenca tega ucinka je bila ob celekoksibu znacilno manjša ne glede na uporabo ali neuporabo acetilsalicilne kisline.
Patients known to be CYP2C9 poor metabolisers should be treated with caution. 
Bolnike, ki so slabi slabi metabolizatorji s CYP2C9, je treba zdraviti previdno.
Twenty-two percent of enrolled patients took concomitant low-dose acetylsalicylic acid (£325 mg/day), 
Dvaindvajset odstotkov vkljucenih bolnikov je hkrati jemalo nizke odmerke acetilsalicilne kisline (£ 325 mg/dan), predvsem za kardiovaskularno profilakso.
Concomitant use of 200 mg single dose of celecoxib and 200 mg once daily of fluconazole, a potent CYP2C9 inhibitor, resulted in a mean increase in celecoxib Cmax of 60% and in AUC of 130%. 
Socasna uporaba enkratnega odmerka 200 mg celekoksiba in 200 mg flukonazola (mocnega zaviralca CYP2C9) enkrat na dan je povzrocila povprecno povecanje Cmax celekoksiba za 60 % in njegove AUC za 130 %.
Breast feeding (See 4.6 and 5.3). 
Dojenje (glejte poglavji 4.6 in 5.3).
4.6 Pregnancy and lactation 
4.6 Nosecnost in dojenje
As the cardiovascular risks of celecoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. 
Ker se tveganje za srcnožilna obolenja pri višjih odmerkih celekoksiba in daljši izpostavljenosti zdravilu lahko poveca, naj bo trajanje zdravljenja cim krajše, dnevni odmerek pa najmanjši, ki je še ucinkovit.
Experience in such patients is limited to cirrhotic patients (See 4.3, 4.4 and 5.2). 
Izkušnje s takšnimi bolniki so omejene predvsem na tiste s cirozo (glejte poglavja 4.3, 4.4 in 5.2).
Conventional embryo-fetal toxicity studies resulted in dose dependent occurrences of diaphragmatic hernia in rat fetuses and of cardiovascular malformations in rabbit fetuses at systemic exposures to free drug approximately 5X (rat) and 3X (rabbit) higher than those achieved at the maximum recommended daily human dose (400 mg). 
Konvencionalne raziskave toksicnosti zdravila za zarodek in plod so pokazale od odmerka odvisno pojavnost hernije diafragme pri podganjih plodih in od odmerka odvisno pojavnost srcnožilnih malformacij pri kuncjih plodih pri sistemski izpostavljenosti prostemu zdravilu, ki je bila približno 5x (podgane) oz. 3x (kunci) višja kot jo dosežemo z maksimalnim priporocenim dnevnim odmerkom za ljudi (400 mg).
Immune system disorders: Very rare: serious allergic reactions, anaphylactic shock 
Bolezni imunskega sistema Zelo redki: resna alergijska reakcija, anafilakticni šok
Celecoxib is metabolised in the liver by hydroxylation, oxidation and some glucuronidation. 
Celekoksib se presnovi v jetrih s hidroksilacijo, oksidacijo in deloma z glukuronidacijo.
In patients on concurrent therapy with warfarin, serious bleeding events have occurred. 
Pri bolnikih, socasno zdravljenih z varfarinom, so se pojavile resne krvavitve.
However, adequate monitoring for methotrexate-related toxicity should be considered when combining these two drugs. 
Vendar je med socasno uporabo teh dveh zdravil priporocljivo ustrezno spremljati toksicne ucinke metotreksata.
For all strokes, there was no increased event rate with celecoxib compared with placebo. 
Za vse kapi skupaj se delež incidentov pri celekoksibu ni razlikoval od placeba.
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [Item to be completed by the Marketing Authorisation Holder once the Marketing Authorisation has been granted or renewed.] 
DATUM DOVOLJENJA ZA PROMET Tocka bo dopolnjena s strani imetnika dovoljenja za promet, po izdaji ali podaljšanju odlocbe.
The incidence of clinically significant decreases in haemoglobin (>2 g/dL), confirmed by repeat testing, was significantly lower in patients on celecoxib compared to the NSAID group, relative risk 0.29, 95% CI 0.17- 0.48. 
Incidenca klinicno pomembnega znižanja hemoglobina (> 2 g/dl), potrjenega s ponovnim testiranjem, je bila znacilno manjša med bolniki, ki so dobivali celekoksib, kot med bolniki, ki so dobivali nesteroidne antirevmatike (relativno tveganje 0,29, 95 % IZ 0,17-0,48).
Pharmacokinetic interactions 
Farmakokineticno medsebojno delovanje
Cardiac disorders Uncommon: myocardial infarction*, heart failure, palpitations 
Srcne bolezni Obcasni: miokardni infarkt*, srcno popušcanje, palpitacije