natgillin/translations-raw huggingface dataset:
3.23 for etoricoxib and 4.96 for diclofenac in the MEDAL Study; 9.12 with etoricoxib and 12.28 with diclofenac in the EDGE study; and 3.71 with etoricoxib and 4.81 with diclofenac in the EDGE II study.
3, 23 za etorikoksib in 4, 96 za diklofenak v študiji MEDAL, 9, 12 za etorikoksib in 12, 28 za diklofenak v študiji EDGE ter 3, 71 za etorikoksib in 4, 81 za diklofenak v študiji EDGE II.
The upper GI benefit for etoricoxib compared with diclofenac was not statistically significant in patients taking concomitant low-dose aspirin (approximately 33% of patients).
Pri bolnikih, ki so sočasno jemali majhen odmerek acetilsalicilne kisline (približno 33% bolnikov), korist etorikoksiba za zgornja prebavila v primerjavi z diklofenakom ni bila statistično pomembna.
The rate for confirmed upper GI events in elderly patients was evaluated and the largest reduction was observed in patients ≥ 75 years of age (1.35 [95% CI 0.94, 1.87] vs.
Največje zmanjšanje so opazili pri bolnikih, starih nad 75 let ali starejših (1, 35 [95% IZ:
2.78 [95% CI 2.14, 3.56] events per hundred patient-years for etoricoxib and diclofenac, respectively.
2, 14, 3, 56] dogodkov na sto bolnik- let pri diklofenaku).
Etoricoxib was associated with a statistically significantly lower rate of discontinuations due to hepatic- related adverse experiences than diclofenac.
Uporaba etorikoksiba je bila povezana s statistično pomembno manjšim deležem prekinitev zdravljenja zaradi z jetri povezanih neželenih dogodkov kot uporaba diklofenaka.
In the pooled MEDAL Program, 0.3% of patients on etoricoxib and 2.7% of patients on diclofenac discontinued due to hepatic-related adverse experiences.
V združenem programu MEDAL je bilo zaradi z jetri povezanih neželenih dogodkov zdravljenje prekinjeno pri 0, 3% bolnikov, ki so prejemali etorikoksib, in 2, 7% bolnikov, ki so prejemali diklofenak.
The rate per hundred patient-years was 0.22 on etoricoxib and 1.84 for diclofenac (p-value was < 0.001 for etoricoxib vs. diclofenac).
Delež na sto bolnik- let je za etorikoksib znašal 0, 22, za diklofenak pa 1, 84 (p- vrednost je bila < 0, 001 za etorikoksib v primerjavi z diklofenakom).
Additional Thrombotic Cardiovascular Safety Data In clinical studies excluding the MEDAL Program Studies, approximately 3100 patients were treated with etoricoxib ≥ 60 mg daily for 12 weeks or longer.
Zdravljenje je trajalo 12 tednov ali več.
There was no discernible difference in the rate of confirmed serious thrombotic cardiovascular events between patients receiving etoricoxib ≥ 60 mg, placebo, or non-
Deleži potrjenih resnih trombotičnih srčno- žilnih zapletov se pri bolnikih, ki so prejemali etorikoksib v odmerku ≥ 60 mg, placebo ali NSAR- e, razen naproksena, niso opazno razlikovali.
However, the rate of these events was higher in patients receiving etoricoxib compared with those receiving naproxen 500 mg twice daily.
Vendar je bil delež teh zapletov večji pri bolnikih, ki so prejemali etorikoksib, kot pri bolnikih, ki so prejemali naproksen v odmerku 500 mg dvakrat na dan.
The difference in antiplatelet activity between some COX-1 inhibiting NSAIDs and selective COX-2 inhibitors may be of clinical significance in patients at risk of thrombo-embolic events.
Razlika v antitrombotičnem delovanju med nekaterimi NSAR- i, ki zavirajo COX- 1, in selektivnimi zaviralci COX- 2 je pri bolnikih s tveganjem za trombembolične dogodke lahko klinično pomembna.
Additional Gastrointestinal Safety Data In two 12-week double-blind endoscopy studies, the cumulative incidence of gastroduodenal ulceration was significantly lower in patients treated with etoricoxib 120 mg once daily than in patients treated with either naproxen 500 mg twice daily or ibuprofen 800 mg three times daily.
V dveh 12- tedenskih, dvojno slepih endoskopskih študijah je bila kumulativna pojavnost razjed želodca in dvanajstnika pomembno manjša pri bolnikih, ki so se zdravili z etorikoksibom v odmerku 120 mg enkrat na dan, kot pri bolnikih, ki so se zdravili z naproksenom v odmerku 500 mg dvakrat na dan ali ibuprofenom v odmerku 800 mg trikrat na dan.
Etoricoxib had a higher incidence of ulceration as compared to placebo.
Pojavnost razjed je bila pri etorikoksibu večja kot pri placebu.
Renal Function Study in the Elderly A randomized, double-blind, placebo-controlled, parallel-group study evaluated the effects of 15 days of treatment of etoricoxib (90 mg), celecoxib (200 mg bid), naproxen (500 mg bid) and placebo on urinary sodium excretion, blood pressure, and other renal function parameters in subjects 60 to 85 years of age on a 200-mEq/ day sodium diet.
V randomizirani, dvojno slepi, s placebom primerjani vzporedni študiji so ocenjevali učinek 15 - dnevnega zdravljenja z etorikoksibom (90 mg), celekoksibom (200 mg dvakrat na dan), naproksenom (500 mg dvakrat na dan) in placebom na izločanje natrija v urinu, krvni tlak in druge kazalce delovanja ledvic pri preiskovancih, starih 60 do 85 let, na dieti z 200 mEq natrija na dan.
Etoricoxib, celecoxib, and naproxen had similar effects on urinary sodium excretion over the 2 weeks of treatment.
5. 2 Farmakokinetične lastnosti
Absorption Orally administered etoricoxib is well absorbed.
Absorpcija Peroralno zaužiti etorikoksib se dobro absorbira.
The absolute bioavailability is approximately 100%.
Absolutna biološka uporabnost je približno 100%.
Following 120 mg once-daily dosing to steady state, the peak plasma concentration (geometric mean Cmax = 3.6 µg/ ml) was observed at approximately 1 hour (Tmax) after administration to fasted adults.
Po odmerjanju 120 mg enkrat na dan do stanja dinamičnega ravnovesja so maksimalno plazemsko koncentracijo (geometrična sredina Cmax = 3, 6 µg/ ml) pri odraslem izmerili približno eno uro (Tmax) po zaužitju na tešče.
The geometric mean area under the curve (AUC0-24hr) was 37.8 µg• hr/ ml.
Geometrična sredina površine pod krivuljo (AUC0– 24 ur) je znašala 37, 8 µg• h/ ml.
The rate of absorption was affected, resulting in a 36% decrease in Cmax and an increase in Tmax by 2 hours.
Vplivalo je na hitrost absorpcije in povzročilo 36% zmanjšanje Cmax in podaljšanje Tmax za 2 uri.
Distribution Etoricoxib is approximately 92% bound to human plasma protein over the range of concentrations of 0.05 to 5 µg/ ml.
Porazdelitev Približno 92% etorikoksiba se pri ljudeh v koncentracijah 0, 05 do 5 µg/ ml veže na plazemske beljakovine.
Etoricoxib crosses the placenta in rats and rabbits, and the blood-brain barrier in rats.
Pri podganah prehaja krvno- možgansko pregrado.
Metabolism Etoricoxib is extensively metabolised with < 1% of a dose recovered in urine as the parent drug.
Presnova Etorikoksib se močno presnavlja, < 1% odmerka se pojavi v urinu v obliki prvotne učinkovine.
The major route of metabolism to form the 6’ -hydroxymethyl derivative is catalyzed by CYP enzymes.
Glavna presnovna pot je tvorba 6 '- hidroksimetilnega presnovka, ki jo katalizirajo encimi CYP.
In vitro studies indicate that CYP2D6, CYP2C9, CYP1A2 and CYP2C19 also can catalyse the main metabolic pathway, but their quantitative roles in vivo have not been studied.
In vitro študije nakazujejo, da lahko tudi CYP2D6, CYP2C9, CYP1A2 in CYP2C19 katalizirajo glavno presnovno pot, vendar njihove kvantitativne vloge niso preučevali in vivo.
The principal metabolite is the 6’ -carboxylic acid derivative of etoricoxib formed by further oxidation of the 6’ -hydroxymethyl derivative.
Glavni presnovek je 6 '- karboksilni derivat etorikoksiba, ki nastane z nadaljnjo oksidacijo 6' - hidroksimetilnega presnovka.
These principal metabolites either demonstrate no measurable activity or are only weakly active as COX-2 inhibitors.
Ta glavna presnovka nimata merljive aktivnosti ali le šibko zavirata COX- 2.
None of these metabolites inhibit COX-1.
Noben od teh presnovkov ne zavira COX- 1.
23 Following administration of a single 25-mg radiolabeled intravenous dose of etoricoxib to healthy subjects, 70% of radioactivity was recovered in urine and 20% in faeces, mostly as metabolites.
Izločanje Po enkratnem intravenskem odmerku 25 mg radioaktivno označenega etorikoksiba, ki so ga dobili zdravi preiskovanci, se je 70% radioaktivnosti izločilo v urinu in 20% v blatu, večinoma v obliki presnovkov.
Less than 2% was recovered as unchanged drug.
Manj kot 2% sta se izločila v obliki nespremenjene učinkovine.
The plasma clearance after a 25-mg intravenous dose is estimated to be approximately 50 ml/ min.
Ocenjujejo, da znaša plazemski očistek po 25 mg intravenskem odmerku približno 50 ml/ min.
Characteristics in patients
25 Značilnosti pri bolnikih
Pharmacokinetics in the elderly (65 years of age and older) are similar to those in the young.
Farmakokinetika pri starejših bolnikih (starih 65 let ali več) je podobna kot pri mlajših bolnikih.
The pharmacokinetics of etoricoxib are similar between men and women.
Farmakokinetika etorikoksiba je pri moških in ženskah podobna.
Patients with mild hepatic dysfunction (Child-Pugh score 5-6) administered etoricoxib 60 mg once daily had an approximately 16% higher mean AUC as compared to healthy subjects given the same regimen.
Jetrna insuficienca: pri bolnikih z blago motnjo delovanja jeter (ocena po Child- Pughu 5– 6), ki so dobivali 60 mg etorikoksiba enkrat na dan, je bila povprečna AUC za približno 16% večja kot pri zdravih preiskovancih, ki so dobivali enak odmerek.
Patients with moderate hepatic dysfunction (Child-Pugh score 7-9) administered etoricoxib 60 mg every other day had similar mean AUC to the healthy subjects given etoricoxib 60 mg once daily; etoricoxib 30 mg once daily has not been studied in this population.
Etorikoksiba v odmerku 30 mg enkrat na dan pri tej populaciji niso preučevali.
(See sections 4.2 and 4.3.)
Kliničnih ali farmakokinetičnih podatkov za bolnike s hudo motnjo delovanja jeter (ocena po Child- Pughu ≥ 10) nimamo (glejte poglavji 4. 2 in 4. 3).
The pharmacokinetics of a single dose of etoricoxib 120 mg in patients with moderate to severe renal insufficiency and patients with end-stage renal disease on hemodialysis were not significantly different from those in healthy subjects.
Farmakokinetika enkratnega odmerka 120 mg etorikoksiba pri bolnikih z zmerno do hudo ledvično insuficienco ter pri bolnikih s končno ledvično odpovedjo na hemodializi, se ni pomembno razlikovala od farmakokinetike pri zdravih preiskovancih.
Hemodialysis contributed negligibly to elimination (dialysis clearance approximately 50 ml/ min).
Hemodializa je k izločanju prispevala le neznatno (očistek dialize približno 50 ml/ min).
(See sections 4.3 and 4.4.)
(Glejte poglavji 4. 3 in 4. 4.)
The pharmacokinetics of etoricoxib in paediatric patients (< 12 years old) have not been studied.
Farmakokinetike etorikoksiba pri pediatričnih bolnikih (< 12 let) niso preučevali.
In a pharmacokinetic study (n=16) conducted in adolescents (aged 12 to 17) the pharmacokinetics in adolescents weighing 40 to 60 kg given etoricoxib 60 mg once daily and adolescents > 60 kg given etoricoxib 90 mg once daily were similar to the pharmacokinetics in adults given etoricoxib 90 mg once daily.
V farmakokinetični študiji (n = 16) pri mladostnikih (starih 12 do 17 let) je bila farmakokinetika pri mladostnikih s telesno maso 40 do 60 kg, ki so dobivali etorikoksib v odmerku 60 mg enkrat na dan, in mladostnikih s telesno maso > 60 kg, ki so dobivali etorikoksib v odmerku 90 mg enkrat na dan, podobna farmakokinetiki pri odraslih, ki so dobivali etorikoksib v odmerku 90 mg enkrat na dan.
Safety and effectiveness of etoricoxib in paediatric patients have not been established (see section 4.2).
Varnosti in učinkovitosti etorikoksiba pri otrocih niso dokazali (glejte poglavje 4. 2).
Rats developed hepatocellular and thyroid follicular cell adenomas at > 2-times the daily human dose [90 mg] based on systemic exposure when dosed daily for approximately two years.
Pri podganah so se pojavili hepatocelularni adenomi in folikularni adenomi ščitnice pri > 2- kratnem dnevnem odmerku za človeka (90 mg) glede na sistemsko izpostavljenost pri dnevnem odmerjanju približno dve leti.
In the 14-week toxicity study etoricoxib caused gastrointestinal ulcers at exposures greater than those seen in man at the therapeutic dose.
V 14 - tedenski študiji toksičnosti je etorikoksib povzročil razjede v prebavilih pri izpostavljenosti, večji od izpostavljenosti človeka pri terapevtskem odmerku.
In the 53- and 106-week toxicity study, gastrointestinal ulcers were also seen at exposures comparable to those seen in man at the therapeutic dose.
V 53 - in 106- tedenskih študijah toksičnosti so razjede v prebavilih opazili tudi pri izpostavljenostih, ki so bile primerljive z izpostavljenostjo človeka pri terapevtskem odmerku.
Etoricoxib was not teratogenic in reproductive toxicity studies conducted in rats at 15 mg/ kg/ day (this represents approximately 1.5 times the daily human dose [90 mg] based on systemic exposure).
Etorikoksib ni deloval teratogeno v študijah reproduktivne toksičnosti pri podganah, ki so dobivale odmerek 15 mg/ kg/ dan (kar glede na sistemsko izpostavljenost ustreza približno 1, 5- kratnemu priporočenemu dnevnemu odmerku pri človeku [90 mg]).
However no treatment-related external or skeletal foetal
Pri kuncih so pri izpostevljenosti, ki je bila manjša od izpostavljenosti človeka pri klinični uporabi dnevnega odmerka (90 mg), opazili z zdravljenjem povezano večjo pojavnost kardiovaskularnih malformacij, niso pa opazili nobenih z zdravljenjem povezanih malformacij na zunanjosti ali skeletu plodov.
In rats and rabbits, there was a dose dependent increase in post implantation loss at exposures greater than or equal to 1.5 times the human exposure (see sections 4.3 and 4.6).
Pri podganah in kuncih so pri izpostavljenosti, ki je bila enaka ali večja od 1, 5- kratne izpostavljenosti človeka, ugotovili od odmerka odvisno povečanje izgub zarodkov po ugnezdenju (glejte poglavji 4. 3 in 4. 6).
Calcium hydrogen phosphate (anhydrous) Croscarmellose sodium Magnesium stearate Microcrystalline cellulose
Jedro: brezvodni kalcijev hidrogenfosfat premreženi natrijev karmelozat magnezijev stearat mikrokristalna celuloza
Carnauba wax Lactose monohydrate Hypromellose Titanium dioxide (E171) Triacetin The 30-, 60- and 120-mg tablets also contain indigo carmine lake (E132) and yellow ferric oxide (E172).
Obloga tablete: karnauba vosek laktoza monohidrat hipromeloza titanov dioksid (E171) triacetin 30 mg, 60 mg in 120 mg tablete vsebujejo še indigo karmin (E132) in rumeni železov oksid (E172).
Keep the container tightly closed in order to protect from moisture.
Plastenko shranjujte tesno zaprto za zagotovitev zaščite pred vlago.
30 mg Aluminum/ aluminium blisters in packs containing 7 and 28 tablets.
30 mg Aluminij/ aluminij pretisni omoti v škatlah po 7 ali 28 tablet.
60, 90 and 120 mg Aluminum/ aluminium blisters in packs containing 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 or 100 tablets.
Aluminij/ aluminij pretisni omoti v škatlah po 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 ali 100 tablet.
Aluminum/ aluminium blisters (unit doses) in packs of 50 or 100 tablets.
Aluminij/ aluminij pretisni omoti (enoodmerni) v škatlah po 50 ali 100 tablet.
White, round, HDPE bottles with a white, polypropylene closure containing 30 tablets and two1-gram desiccant containers or 90 tablets and one1-gram desiccant container.
Bele, okrogle plastenke iz polietilena visoke gostote (HDPE) z belim polipropilenskim zamaškom s 30 tabletami in dvema 1- gramskima sušilnima sredstvoma ali 90 tabletami in enim 1- gramskim sušilnim sredstvom.
6.6 Special precautions for disposal 25 No special requirements.
6. 6 Posebni varnostni ukrepi za zdstranjevanje in ravnanje z zdravilom
[See Annex 1- To be completed nationally.] {Name and address} {tel} {fax} {e-mail}
27 [Glejte Dodatek I - Izpolni država članica] {Ime in naslov} {tel.} {fax} {e- mail}
[To be completed nationally.]
[Izpolni država članica]
26 LABELLING
28 OZNAČEVANJE
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
29 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
< ARCOXIA (see Annex 1) > 30 mg film-coated tablets< ARCOXIA (see Annex 1) > 60 mg film-coated tablets< ARCOXIA (see Annex 1) > 90 mg film-coated tablets < ARCOXIA (see Annex 1) > 120 mg film-coated tablets [See Annex I - To be completed nationally]
< ARCOXIA (Glejte Dodatek I) > 30 mg filmsko obložene tablete < ARCOXIA (Glejte Dodatek I) > 60 mg filmsko obložene tablete < ARCOXIA (Glejte Dodatek I) > 90 mg filmsko obložene tablete < ARCOXIA (Glejte Dodatek I) > 120 mg filmsko obložene tablete [Glejte Dodatek I – Izpolni država članica]
Lactose (see leaflet for more information).
Laktoza (za več informacij glejte Navodilo za uporabo).
30mg 7 Film-coated tablets 28 Film-coated tablets
30 mg 7 filmsko obloženih tablet 28 fimsko obloženih tablet
60 mg – 90 mg -120mg 2 Film coated tablets 5 Film-coated tablets 7 Film-coated tablets 10 Film-coated tablets 14 Film-coated tablets 20 Film-coated tablets 28 Film-coated tablets 30 Film-coated tablets 50 Film-coated tablets 84 Film-coated tablets 98 Film-coated tablets 100 Film-coated tablets 50 Film-coated tablets (unit dose) 100 Film-coated tablets (unit dose) 30 Film-coated tablets (HDPE bottles) 90 Film-coated tablets (HDPE bottles)
60 mg- 90mg- 120mg 2 filmsko obloženi tableti 5 filmsko obloženih tablet 7 filmsko obloženih tablet 10 filmsko obloženih tablet 14 filmsko obloženih tablet 20 filmsko obloženih tablet 28 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 84 filmsko obloženih tablet 98 filmsko obloženih tablet 100 filmsko obloženih tablet 50 filmsko obloženih tablet (enoodmerni pretisni omot) 100 filmsko obloženih tablet (enoodmerni pretisni omot) 30 filmsko obloženih tablet (HDPE plastenke) 90 filmsko obloženih tablet (HDPE plastenke)
METHOD AND ROUTE(S) OF ADMINISTRATION
POSTOPEK IN POT( I) UPORABE ZDRAVILA 30 Peroralna uporaba.
[See Annex I - To be completed nationally]
< [Glejte Dodatek I - Izpolni država članica]
{Name and Address }< {tel }> < {fax }> < {e-mail }>
{Ime in naslov} < {tel.} > < {fax} > < {e- mail} >
GENERAL CLASSIFICATION FOR SUPPLY 29 [To be completed nationally]
31 [Izpolni država članica]
30 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
32 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
HDPE BOTTLE
HDPE PLASTENKA
< ARCOXIA (see Annex 1) > 60 mg film-coated tablets< ARCOXIA (see Annex 1) > 90 mg film-coated tablets< ARCOXIA (see Annex 1) > 120 mg film-coated tablets [See Annex I - To be completed nationally]
< ARCOXIA (Glejte Dodatek I) > 60 mg filmsko obložene tablete < ARCOXIA (Glejte Dodatek I) > 90 mg filmsko obložene tablete < ARCOXIA (Glejte Dodatek I) > 120 mg filmsko obložene tablete [Glejte Dodatek I – Izpolni država članica]
30 Film coated tablets (HDPE bottles) 90 Film coated tablets (HDPE bottles)
30 filmsko obloženih tablet (HDPE plastenke) 90 filmsko obloženih tablet (HDPE plastenke)
32 PACKAGE LEAFLET
34 NAVODILO ZA UPORABO
< ARCOXIA > 30 mg film-coated tablets< ARCOXIA > 60 mg film-coated tablets< ARCOXIA > 90 mg film-coated tablets < ARCOXIA > 120 mg film-coated tablets
< ARCOXIA (Glejte Dodatek I) > 30 mg filmsko obložene tablete < ARCOXIA (Glejte Dodatek I) > 60 mg filmsko obložene tablete < ARCOXIA (Glejte Dodatek I) > 90 mg filmsko obložene tablete < ARCOXIA (Glejte Dodatek I) > 120 mg filmsko obložene tablete
[See Annex I – To be completed nationally]
[Glejte Dodatek I – Izpolni država članica]
What< ARCOXIA > is and what it is used for 2.
Kaj je zdravilo < ARCOXIA > in za kaj ga uporabljamo 2.
Before you take< ARCOXIA > 3.
Kaj morate vedeti, preden boste vzeli zdravilo < ARCOXIA > 3.
How to take< ARCOXIB > 4.
Kako jemati zdravilo < ARCOXIA > 4.
How to store< ARCOXIA > 6.
Shranjevanje zdravila < ARCOXIA > 6.
WHAT< ARCOXIA > IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO < ARCOXIA > IN ZA KAJ GA UPORABLJAMO
• < ARCOXIA > is one of a group of medicines called selective COX-2 inhibitors.
• Zdravilo < ARCOXIA > je eno izmed zdravil iz skupine zdravil, imenovanih selektivni zaviralci COX- 2.
These belong to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). • < ARCOXIA > helps to reduce the pain and swelling (inflammation) in the joints and muscles of people with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout.
Ti spadajo v družino zdravil, ki jih imenujemo nesteroidna protivnetna zdravila (NSAR- i). • Zdravilo < ARCOXIA > pomaga ublažiti bolečino in otekanje (vnetje) sklepov in mišic, pri bolnikih z osteoartrozo, revmatoidnim artritisom, ankilozirajočim spondilitisom ali s protinom.
BEFORE YOU TAKE< ARCOXIA >
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO < ARCOXIA >
Do not take< ARCOXIA >: • if you are allergic (hypersensitive) to etoricoxib or any of the other ingredients of < ARCOXIA > (see Further information, section 6) • if you are allergic to non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin and COX-2 inhibitors (see Possible Side Effects, section 4) • if you have a current stomach ulcer or bleeding in your stomach or intestines • if you have serious liver disease • if you have serious kidney disease • if you are or could be pregnant or are breast-feeding (see ‘Pregnancy and breast feeding’) • if you are under 16 years of age • if you have inflammatory bowel disease, such as Crohn’s Disease, Ulcerative Colitis, or Colitis • if your doctor has diagnosed heart problems including heart failure (moderate or severe types), angina (chest pain) or if you have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrow or blocked arteries), or any kind of stroke (including mini- stroke, transient ischaemic attack or TIA).
36 • če ste alergični na nesteroidne antirevmatike (NSAIR- e), vključno z acetilsalicilno kislino in z zaviralci COX- 2 (glejte poglavje 4 Možni neželeni učinki). • če ravno imate želodčno razjedo ali krvavitev iz želodca ali črevesa. • če imate hudo bolezen jeter. • če imate hudo bolezen ledvic. • če ste ali bi lahko bili noseči ali če dojite (glejte 'Nosečnost in dojenje'). • če ste mlajši od 16 let. • če imate vnetno bolezen črevesa, kot so Crohnova bolezen, ulcerozni kolitis ali kolitis. • če je zdravnik pri vas ugotovil bolezni srca, vključno s srčnim popuščanjem (zmerno ali hudo obliko), angino pektoris (bolečina v prsnem košu), ali če ste kdaj imeli srčni napad, obvodno operacijo koronark ("bypass"), bolezen perifernih arterij (slaba prekrvavitev v nogah ali stopalih zaradi zožanih ali zamašenih arterij) ali možgansko kap (vključno z malo možgansko kapjo ali tranzitorno ishemično atako (TIA)).
Etoricoxib may slightly increase your risk of heart attack and stroke and this is why it should not be used in those who have already had heart problems or stroke • if you have high blood pressure that has not been controlled by treatment (check with your doctor or nurse if you are not sure whether your blood pressure is adequately controlled)
Etorikoksib lahko rahlo poveča tveganje za pojav srčnega napada in možganske kapi, zato ga bolniki, ki so že imeli težave s srcem ali doživeli možgansko kap, ne smejo uporabljati. • če imate visok krvni tlak, ki kljub zdravljenju ni ustrezno nadzorovan (če niste prepičani, če je vaš tlak ustrezno nadzorovan, se posvetujte s svojim zdravnikom ali z medicinsko sestro).
If you think any of these are relevant to you, do not take the tablets until you have consulted your doctor.
Če menite, da karkoli od navedenega velja za vas, tablet ne jemljite, ne da bi se prej posvetovali z zdravnikom.
Take special care with< ARCOXIA > < ARCOXIA > may not be suitable for you, or you may need to be monitored regularly while taking it if any of the following apply to you:
Bodite posebno pozorni pri uporabi zdravila < ARCOXIA > Zdravilo < ARCOXIA > morda ni primerno za vas ali pa morate biti, medtem ko ga jemljete, pod rednim nadzorom zdravnika, če za vas velja kaj od naštetega: