natgillin/translations-raw huggingface dataset:
4.1 Therapeutic indications Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.
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).
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).
4. 2 Odmerjanje in nacin uporabe
4.2 Posology and method of administration 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.
The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis (4.3, 4.4, 4.8 and 5.1).
Obcasno je treba ponovno oceniti potrebo bolnika po lajšanju simptomov in njegov odziv na zdravljenje, še posebej to velja pri bolnikih z osteoartrozo (glejte poglavja 4. 3, 4. 4, 4. 8. in 5. 1.).
Osteoarthritis:
Osteoartroza:
The usual recommended daily dose is 200 mg taken once daily or in two divided doses.
Obicajni priporoceni dnevni odmerek je 200 mg, ki naj ga bolnik vzame naenkrat ali v dveh deljenih odmerkih.
Rheumatoid arthritis:
Revmatoidni artritis:
The initial recommended daily dose is 200 mg taken in two divided doses.
Priporoceni zacetni dnevni odmerek je 200 mg, ki naj ga bolnik vzame v dveh deljenih odmerkih.
Elderly > 65 years:
Razlike med rasami:
As in younger adults, 200 mg per day should be used initially.
200 mg na dan.
(See 4.4 and 5.2).
Posebna previdnost je potrebna pri starejših osebah, pri katerih je telesna masa nižja od 50 kg (glejte poglavji 4. 4 in 5. 2).
Treatment should be initiated at half the recommended dose in patients with established moderate liver impairment with a serum albumin of 25-35 g/ l.
Pri bolnikih z ugotovljeno zmerno jetrno okvaro (serumski albumin 25- 35 g/ l) zacnemo zdravljenje s polovicnim priporocenim odmerkom.
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).
20 Renal impairment:
Ledvicna okvara:
(See 4.3, 4.4 and 5.2).
Izkušnje z uporabo celekoksiba pri bolnikih z blago do zmerno ledvicno okvaro so omejene, zato takšne bolnike zdravimo previdno (glejte polgavja 4. 3, 4. 4 in 5. 2).
Celecoxib is not indicated for use in children.
Celekoksib ni indiciran za uporabo pri otrocih.
4.3 Contraindications History of hypersensitivity to the active substance or to any of the excipients (see 6.1).
4. 3 Kontraindikacije
Known hypersensitivity to sulphonamides.
.
Active peptic ulceration or gastrointestinal (GI) bleeding.
Preobcutljivost za ucinkovino ali za katero od pomožnih snovi.
In pregnancy and in women of childbearing potential unless using an effective method of contraception (See 4.5).
V casu nosecnosti in pri ženskah v rodni dobi, razen ce uporabljajo ucinkovito metodo kontracepcije (glejte poglavje 4. 4).
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).
The potential for human risk in pregnancy is unknown, but cannot be excluded.
Pri cloveku nevarnost za plod zaradi jemanja zdravila v casu nosecnosti ni znana, a je ne moremo izkljuciti.
Breast feeding (See 4.6 and 5.3).
Dojenje (glejte poglavji 4. 6 in 5. 3).
Severe hepatic dysfunction (serum albumin < 25 g/ l or Child-Pugh score ≥ 10).
Huda jetrna bolezen (serumski albumin < 25 g/ l ali Child- Pugh > 10).
Patients with estimated creatinine clearance < 30 ml/ min.
Bolniki z ocenjenim ocistkom kreatinina < 30 ml/ min (0, 5 ml/ s).
Inflammatory bowel disease.
4. 4 Posebna opozorila in previdnostni ukrepi
4.4 Special warnings and special precautions for use Upper gastrointestinal complications [perforations, ulcers or bleedings (PUBs)], some of them resulting in fatal outcome, have occurred in patients treated with celecoxib.
Pri bolnikih, zdravljenih s celekoksibom, so se na zgornjih prebavilih pojavljali zapleti (perforacije, ulkusi in krvavitve), ki so bili v nekaterih primerih usodni.
A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs.
Glede GI varnosti pri primerjavi selektivnih zaviralcev COX- 2 in acetilsalicilne kisline ter NSAID- ov in acetilsalicilne kisline po izvedenih dolgotrajnih klinicnih študijah ni bilo nobene bistvene razlike (glejte poglavje 5. 1).
NSAIDs + acetylsalicylic acid has not been demonstrated in long- term clinical trials (see 5.1).
V primerjavi s placebom, so povecano število nevarnih srcnožilnih dogodkov, v glavnem miokardni infarkt, ugotovili pri dolgotrajni, s placebom nadzirani študiji odkrili, pri osebah s sporadicnimi
Increased number of serious cardiovascular events, mainly myocardial infarction, has been found in a long-term placebo-controlled study in subjects with sporadic adenomatous polyps treated with celecoxib at doses of 200mg BID and 400mg BID compared to placebo (see 5.1).
21 adenomatoznimi polipi, zdravljenih s celekoksibom, v odmerkih po 200 mg dvakrat dnevno in 400 mg dvakrat na dan (glejte poglavje 5. 1).
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 vecjih odmerkih celekoksiba in daljši izpostavljenosti zdravilu lahko poveca, naj bo trajanje zdravljenja cim krajše, dnevni odmerek panajmanjši, ki je še ucinkovit.
The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis (4.2, 4.3, 4.8 and 5.1).
Obcasno je treba ponovno oceniti potrebo bolnika po lajšanju simptomov in njegov odziv na zdravljenje, še posebej to velja pri bolnikih z osteoartrozo (glejte poglavja 4. 3, 4. 4, 4. 8. in 5. 1.).
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 5. 1).
COX-2 selective inhibitors are not a substitute for acetylsalicylic acid for prophylaxis of cardiovascular
Selektivni zaviralci COX- 2 ne vplivajo na antitrombocitno delovanje, zato niso nadomestilo za acetilsalicilno kislino v profilaksi kardiovaskularnih trombembolicnih bolezni.
Therefore, antiplatelet therapies should not be discontinued (see section 5.1).
Zato antiagregacijskega zdravljenja ne smemo ukiniti (glejte poglavje 5. 1.).
Therefore, celecoxib should be used with caution in patients with history of cardiac failure, left ventricular dysfunction or hypertension, and in patients with pre-existing oedema from any other reason, since prostaglandin inhibition may result in deterioration of renal function and fluid retention.
Zavrtje prostaglandinov namrec lahko poslabša delovanje ledvic in povzroci zastajanje tekocine.
Compromised renal or hepatic function and especially cardiac dysfunction are more likely in the elderly and therefore medically appropriate supervision should be maintained.
Zato je pri njih potreben stalen ustrezen zdravniški nadzor.
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).
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).
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use ofcelecoxib (see 4.8).
Z uporabo celekoksiba so bile povezane resne kožne reakcije, nekatere s smrtnim izidom, med njimi eksfoliacijski dermatitis, Stevens- Johnsonov sindrom in toksicna epidermalna nekroliza (glejte poglavje 4. 8).
Serious hypersensitivity reactions (anaphylaxis and angioedema) have been reported in patients receiving celecoxib (see 4.8).
Pri bolnikih, ki so dobivali celekoksib, so bile opisane resne preobcutljivostne reakcije (anafilaksija in angioedem) (glejte poglavje 4. 8).
Patients with a history of sulphonamide allergy or any drug allergy may be at greater risk of serious skin reactions or hypersensitivity reactions (see 4.3).
Resne kožne reakcije ali preobcutljivostne reakcije lahko bolj ogrožajo bolnike z anamnezo alergije na sulfonamide ali alergije na kakršnakoli zdravila (glejte poglavje 4. 3).
Caution should be exercised when combining celecoxib with warfarin and other oral anticoagulants (See 4.5).
Uporaba celekoksiba v kombinaciji z varfarinom ali drugimi peroralnimi antikoagulansi zato zahteva previdnost (glejte poglavje 4. 5).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose 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.
4.5 Interaction with other medicinal products and other forms of interaction Pharmacodynamic interactions Anticoagulant activity should be monitored particularly in the first few days after initiating or changing the dose of celecoxib in patients receiving warfarin or other anticoagulants since these patients have an increased risk of bleeding complications.
Te bolnike namrec bolj ogrožajo zapleti s krvavitvami.
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).
NSAIDs may reduce the effect of diuretics and antihypertensive medicinal products.
NSAID- i lahko poslabšajo ucinek diuretikov in antihipertenzivov.
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.
22 Coadministration of NSAIDs and cyclosporin or tacrolimus have been suggested to increase the nephrotoxic effect of cyclosporin and tacrolimus.
Socasna uporaba nesteroidnih antirevmatikov in ciklosporina ali takrolimusa domnevno poveca nefrotoksicni ucinek teh dveh zdravil.
In the submitted studies, as with other NSAIDs, an increased risk of gastrointestinal ulceration or other gastrointestinal complications compared to use of celecoxib alone was shown for concomitant administration of low-dose acetylsalicylic acid (see 5.1).
Tako kot za druge nesteroidne antirevmatike, so v predloženih študijah tudi za celekoksib ugotovili, da njegovo socasno uporabo z majhnimi odmerki acetilsalicilne kisline spremlja vecje tveganje za ulkuse in druge zaplete na prebavilih kot uporabo celekoksiba samega (glejte poglavje 5. 1)
Effects of celecoxib on other drugs Celecoxib is an inhibitor of CYP2D6.
Farmakokineticno medsebojno delovanje Vplivi celekoksiba na druga zdravila Celekoksib je zaviralec CYP2D6.
During celecoxib treatment, the plasma concentrations of the CYP2D6 substrate dextromethorphan were increased by 136%.
Plazemska koncentracija dekstrometorfana, substrata CYP2D6, se je med zdravljenjem s celekoksibom povecala za okrog 136%.
Examples of drugs which are metabolised by CYP2D6 are antidepressants (tricyclics and SSRIs), neuroleptics, anti- arrhythmic drugs, etc.
Zgledi zdravil, ki se presnavljajo s CYP2D6, so antidepresivi (triciklicni in zaviralci sprejema serotonina), nevroleptiki, antiaritmiki itn.
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).
In healthy subjects, co-administration of celecoxib 200 mg twice daily with 450 mg twice daily of lithium resulted in a mean increase in Cmax of 16% and in AUC of 18% of lithium.
23 Pri zdravih preiskovancih je socasna uporaba 200 mg celekoksiba dvakrat na dan in 450 mg litija dvakrat na dan povzrocila povprecno zvecanje Cmax litija za 16% in njegove AUC za 18%.
Since celecoxib is predominantly metabolised by CYP2C9 it should be used at half the recommended dose in patients receiving fluconazole.
Vplivi drugih zdravil na celekoksib Celekoksib se pretežno presnavlja s CYP2C9, zato je treba pri bolnikih, ki dobivajo flukonazol, uporabiti le polovicen priporoceni odmerek celekoksiba.
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%.
4.6 Pregnancy and lactation No clinical data on exposed pregnancies are available for celecoxib.
Za celekoksib ni na voljo klinicnih podatkov od nosecnic, ki so bile izpostavljene zdravilu.
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).
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).
23 There are no studies on the excretion of celecoxib in human milk.
Študij o izlocanju celekoksiba v materinem mleku pri cloveku ni.
Celecoxib is excreted in the milk of lactating rats at concentrations similar to those in plasma.
Celekoksib se izloca v mleku dojecih podgan v koncentraciji, podobni koncentraciji v plazmi.
4.7 Effects on ability to drive and use machines 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.
4.8 Undesirable effects 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 following events have been reported in patients receiving celecoxib in 12 placebo and/ or active controlled trials.
Pri bolnikih, ki so celekoksib dobivali v 12 preskušanjih, kontroliranih s placebom in/ ali aktivno ucinkovino, so porocali o naslednjih ucinkih.
Side-effects listed have a rate equal or greater than placebo, and the discontinuation rate due to side effects was 7.1% in patients receiving celecoxib and 6.1% in patients receiving placebo.
Delež prekinitev zaradi neželenih ucinkov je bil 7, 1% pri bolnikih, ki so dobivali celekoksib, in 6, 1% pri bolnikih, ki so dobivali placebo.
Additional reactions reported from post-marketing experience in > 70 million treated patients include headache, nausea and arthralgia, and the reactions included as very rare, in italics in the list below.
Med dodatnimi reakcijami, opisanimi v pomarketinškem obdobju pri > 70 milijonih zdravljenih bolnikov, so glavobol, navzeja in artralgija ter reakcije, ki so na spodnjem seznamu navedene v poševnem tisku kot zelo redke.
[Very Common (> 1/ 10), Common (≥ 1/ 100, < 1/ 10) Uncommon (≥ 1/ 1000, < 1/ 100) Rare (≥ 1/ 10,000, < 1/ 1000) Very rare (< 1/ 10,000 including isolated cases)]
[Zelo pogosti (> 1/ 10), pogosti (≥ 1/ 100, < 1/ 10), obcasni (≥ 1/ 1. 000, < 1/ 100), redki (≥ 1/ 10. 000, < 1/ 1. 000), zelo redki (< 1/ 10. 000, vkljucno s posameznimi primeri)]
Blood and the lymphatic system disorders Uncommon: anaemia Rare: leucopenia, thrombocytopenia Very rare: pancytopenia.
Bolezni krvi in limfaticnega sistema Obcasni: anemija Redki: levkopenija, trombocitopenija
Immune system disorders:
24 Zelo redki: pancitopenija
Metabolism and nutrition disorders Uncommon: hyperkalaemia
Bolezni imunskega sistema Zelo redki: resna alergijska reakcija, anafilakticni šok
Psychiatric disorders Common: insomnia Uncommon: anxiety, depression, tiredness Very rare: confusion, hallucinations.
Presnovne in prehranske motnje Obcasni: hiperkaliemija
Nervous system disorders Common: dizziness Uncommon: blurred vision, hypertonia, paraesthesia Rare: ataxia, taste alteration Very rare: aggravated epilepsy, meningitis aseptic, ageusia, anosmia
Psihiatricne motnje Pogosti: nespecnost Obcasni: anksioznost, depresija, utrujenost Zelo redki: zmedenost, halucinacije
Ear and labyrinth disorders Uncommon: tinnitus Very rare: decreased hearing
Bolezni živcevja Pogosti: omotica Obcasni: zamegljen vid, hipertonija, parestezije Redki: ataksija, spremembe okusa Zelo redki: poslabšanje epilepsije, asepticni meningitis, agevzija, anozmija
Cardiac disorders Uncommon: myocardial infarction*, heart failure, palpitations
Ušesne bolezni, vkljucno z motnjami labirinta Obcasni: tinitus Zelo redki: poslabšanje sluha
Vascular disorders Uncommon: hypertension, hypertension aggravated
Srcne bolezni Obcasni: miokardni infarkt *, srcno popušcanje, palpitacije
24 Rare: ischaemic stroke* Very rare: vasculitis.
Žilne bolezni Obcasni: hipertenzija, poslabšanje hipertenzije Redko: ishemicna kap * Zelo redki: vaskulitis
Respiratory, thoracic and mediastinal disorders Common: pharyngitis, rhinitis Uncommon: cough, dyspnoea Very rare: bronchospasm.
Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosti: faringitis, rinitis Obcasni: kašelj, dispneja Zelo redki: bronhospazem
Gastrointestinal disorders Common: abdominal pain, diarrhoea, dyspepsia, flatulence Uncommon: constipation, eructation, gastritis, stomatitis, vomiting, aggravation of gastrointestinal inflammation Rare: duodenal, gastricoesophageal, intestinal and colonic ulceration, dysphagia, intestinal perforation, oesophagitis, melaena Very rare: gastrointestinal haemorrhage, acute pancreatitis, colitis/ colitis aggravated.
Bolezni prebavil Pogosti: bolecine v trebuhu, driska, dispepsija, flatulenca Obcasni: zaprtje, spahovanje, gastritis, stomatitis, bruhanje, poslabšanje želodcnocrevesnega vnetja Redki: razjeda na dvanajstniku, želodcu, požiralniku, tankem in debelem crevesju, disfagija, predrtje crevesa, ezofagitis, melena Zelo redki: gastrointestinalna krvavitev, akutni pankreatitis, kolitis/ poslabšanje kolitisa
Skin and subcutaneous tissue disorders Common: rash Uncommon: urticaria Rare: alopecia, photosensitivity Very rare: angioedema, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, epidermal necrolysis,
Bolezni kože in podkožja Pogosti: izpušcaj Obcasni: urtikarija Redki: alopecija, fotosenzibilnost Zelo redki: angioedem, eksfoliacijski dermatitis, multiformni eritem, Stevens- Johnsonov sindrom, epidermalna nekroliza in multiformni eritem
Musculoskeletal and connective tissue disorders Uncommon: leg cramps Very rare: myositis
25 Bolezni mišicno- skeletnega sistema in vezivnega tkiva Obcasni: krci v nogah Zelo redki: miozitis
General disorders and administration site conditions Common: peripheral oedema/ fluid retention
Splošne težave in spremembe na mestu aplikacije Pogosti: periferni edemi/ zastajanje tekocine
*In a pooled analysis of 20 placebo-controlled studies with duration greater than 2 weeks up to 1 year in patients with OA and RA, the excess rate of myocardial infarction in patients treated with celecoxib 200 or 400 mg daily over placebo was 0.7 events per 1000 patients (Rare) and there was no excess of strokes.
Presežka možganskih kapi ni bilo.
In preliminary data from two studies in patients with colorectal polyps treated with celecoxib 400 mg daily (see Section 5.1) the excess rate over placebo of myocardial infarction over 3 years was 7 events per 1000 patients (Uncommon).
Po preliminarnih podatkih ene od dveh študij pri bolnikih s kolorektalnimi polipi, zdravljenih s 400 mg celekoksiba na dan (glejte poglavje 5. 1), je bil presežni delež miokardnih infarktov v primerjavi s placebom v 3 letih 7 incidentov na 1000 bolnikov (obcasno).
In the same studies, the excess rate for clearly identified ischaemic stroke for the 400 mg daily dose (not including events that were haemorrhagic or of unknown aetiology) was 0.5 event per 1000 over 3 years (Rare).
V isti študiji je bil presežni delež jasno identificirane ishemicne možganske kapi pri odmerku 400 mg na dan (izkljucujoc incidente, ki so bili hemoragicni ali neznane etiologije) 0, 5 incidentov na 1000 v 3 letih (redko).
Single doses up to 1200 mg and multiple doses up to 1200
4. 9 Preveliko odmerjanje
25 mg twice daily have been administered to healthy subjects for nine days without clinically significant adverse effects.
Zdravim preiskovancem so devet dni aplicirali posamicne odmerke 1. 200 mg in veckratne odmerke do 1. 200 mg dvakrat na dan brez klinicno pomembnih neželenih ucinkov.
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.
5.1 Pharmacodynamic properties Pharmacotherapeutic group:
5. 1 Farmakodinamicne lastnosti
ATC code:
Farmakoterapevtska skupina: oznaka ATC:
M01AH01.
M01AH01.
Celecoxib is an oral, selective, cyclooxygenase-2 (COX-2) inhibitor within the clinical dose range (200-400 mg daily).
Peroralno uporabljeni celekoksib v obmocju klinicnih odmerkov selektivno zavira ciklooksigenazo- 2 (COX- 2).
No statistically significant inhibition of COX-1 (assessed as ex vivo inhibition of thromboxane B2 [TxB2] formation) was observed in this dose range in healthy volunteers.
V tem obmocju odmerkov pri zdravih prostovoljcih niso ugotovili statisticno znacilnega zavrtja COX- 1 (ocenjevanega z zavrtjem tvorbe tromboksana B2 [TxB2] ex vivo).
Cyclooxygenase is responsible for generation of prostaglandins.
Znani sta dve izoobliki, COX- 1 in COX- 2.
Two isoforms, COX-1 and COX-2, have been identified.
COX- 2 je
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).
26 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).