natgillin/translations-raw huggingface dataset:
The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks (see sections 4.3, 4.4).
Odlocitev, da se predpiše selektivni zaviralec COX-2, mora temeljiti na oceni vseh tveganj za vsakega posameznega bolnika (glejte poglavji 4.3 in 4.4).
NSAIDs may reduce the effect of diuretics and antihypertensive medicinal products.
NSAID-i lahko poslabšajo ucinek diuretikov in antihipertenzivov.
- Addition of a warning for prescribers to consider discontinuation of therapy if during treatment, patients deteriorate in any of the organ system functions described.
- dodano je opozorilo za predpisovalce zdravila, naj preucijo možnost prekinitve zdravljenja, ce se med zdravljenjem bolniku poslabša katerakoli opisana funkcija organskih sistemov.
Effects of other drugs on celecoxib
Vplivi drugih zdravil na celekoksib
To provide all ongoing epidemiological studies in accordance with updates on on-going post marketing activities (for example, within PSURs for Celebra).
Da bo zagotovil, da so vse potekajoce epidemiološke študije usklajene s posodobitvami potekajocih postmarketinških dejavnosti (na primer, s PSUR-i za zdravilo Celebra).
These data resulted in the worldwide withdrawal of Vioxx (rofecoxib) from the market on 30 September 2004 by the MAH and raised questions regarding the cardiovascular safety of other Cox-2 inhibitors.
Zaradi teh podatkov je imetnik dovoljenja za promet dne 30. septembra 2004 z vseh svetovnih tržišc umaknil zdravilo Vioxx (rofekoksib), pojavila pa so se tudi vprašanja glede kardiovaskularne varnosti drugih zaviralcev Cox-2.
The changes of the Product Information related to the CV can be summarised as follows: - Addition of a statement that decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks.
Spremembe informacij o zdravilu v zvezi s kardiovaskularnim sistemom lahko povzamemo kot sledi: - dodana je izjava, da mora odlocitev o uvedbi selektivnega zaviralca COX-2 temeljiti na vrednotenju celotnega tveganja za posameznega bolnika.
Plasma protein binding is about 97% at therapeutic plasma concentrations and the drug is not preferentially bound to erythrocytes.
Pri terapevtskih koncentracijah v plazmi je vezava na beljakovine v plazmi približno 97-odstotna; zdravilo se ne veže prednostno na eritrocite.
Effects of celecoxib on other drugs
Vplivi celekoksiba na druga zdravila
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
DODATEK II ZNANSTVENI ZAKLJUCKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNACILNOSTI ZDRAVILA, PREDSTAVLJENI S STRANI EVROPSKE AGENCIJE ZA ZDRAVILA
Studies in animals (rats and rabbits) have shown reproductive toxicity, including malformations (see 4.3 and 5.3).
Študije na živalih (podganah in kuncih) so pokazale reprodukcijske toksicne ucinke, vkljucno z malformacijami (glejte poglavji 4.3 in 5.3).
7 MARKETING AUTHORISATION HOLDER {Name and address} [Country name in the language of the text, NO telephone, fax numbers, e-mail addresses or websites.]
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM (Ime in naslov) /Besedilo, številka telefona in faksa, elektronska pošta ali internetni naslov je v jeziku države./
5.3 Preclinical safety data
5.3 Predklinicni podatki o varnosti
Concomitant use of inducers of CYP2C9 such as rifampicin, carbamazepine and barbiturates may reduce plasma concentrations of celecoxib.
Socasna uporaba induktorjev CYP2C9, npr. rifampicina, karbamazepina ali barbituratov, lahko zmanjša koncentracijo celekoksiba v plazmi.
In the event of suspected overdose, appropriate supportive medical care should be provided e.g. by eliminating the gastric contents, clinical supervision and, if necessary, the institution of symptomatic treatment.
Pri sumu na preveliko odmerjanje je treba zagotoviti ustrezno podporno medicinsko oskrbo, npr. odstranitev vsebine želodca, klinicni nadzor in, ce je potrebno, uvesti simptomatsko zdravljenje.
Elderly >65 years: As in younger adults, 200 mg per day should be used initially.
Starejši bolniki (> 65 let): Kot pri mlajših odraslih je treba na zacetku uporabiti 200 mg na dan. Ce je potrebno, se odmerek kasneje poveca na 200 mg dvakrat na dan.
In the latter study, at the lowest systemic exposure where this anomaly occurred in a single animal, the estimated margin relative to the maximum recommended daily human dose was 3X.
V tej raziskavi, v kateri se je pri najmanjši sistemski izpostavljenosti zdravilu ta anomalija pokazala le pri eni eksperimentalni živali, so ocenili, da je mejna vrednost 3x maksimalni priporoceni odmerek za ljudi.
Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ³10).
Huda jetrna bolezen (serumski albumin <25 g/l ali Child-Pugh >10).
- Addition of a warning for patients with a history of any drug allergy.
- dodano je opozorilo za bolnike z anamnezo alergije na katerokoli zdravilo.
Celecoxib is a diaryl-substituted pyrazole, chemically similar to other non-arylamine sulfonamides (e.g. thiazides, furosemide) but differs from arylamine sulfonamides (e.g. sulfamethoxizole and other sulfonamide antibiotics).
Celekoksib je diaril-substituiran pirazol, kemicno podoben drugim nearilaminskim sulfonamidom (npr. tiazidom, furosemidu), a drugacen od arilaminskih sulfonamidov (npr. sulfametoksazola in drugih sulfonamidnih antibiotikov).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100 mg or 200 mg celecoxib.
KAKOVOSTNA IN KOLICINSKA SESTAVA Vsaka trda kapsula vsebuje 100 mg oziroma 200 mg celekoksiba.
Kent CT13 9NJ United Kingdom
Kent CT13 9NJ Velika Britanija
Several clinical studies have been performed confirming efficacy and safety in osteoarthritis and rheumatoid arthritis.
Narejenih je bilo vec klinicnih študij in potrdile so ucinkovitost in varnost pri osteoartritisu in revmatoidnem artritisu.
§ 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.