FrancophonIA/ELRC3.0 huggingface dataset:
English: These effects are usually reversible.
Slovenian: Ti učinki so običajno reverzibilni.
English: No formal interaction studies have been done.
Slovenian: Formalnih študij o medsebojnem delovanju niso opravili.
English: It is to be reconstituted only with one of the following:
Slovenian: Rekonstituira se ga lahko le z naslednjim:
English: The clinical relevance of these observations has not been established.
Slovenian: Klinični pomen teh opažanj ni znan.
English: This medicinal product must not be mixed with other medicinal products except for those mentioned in section 6.6.
Slovenian: Zdravila ni dovoljeno mešati z drugimi zdravili, razen s tistimi, ki so navedena v poglavju 6.6.
English: If a dose lower than 40 mg is required, excess medicine should be discarded.
Slovenian: Če je potreben odmerek, manjši od 40 mg, je treba presežek zdravila zavreči.
English: Additional studies in other surgical settings provided similar observations.
Slovenian: Dodatne študije v drugih kirurških okoliščinah so privedle do podobnih opažanj.
English: The solution is for single use only and must not be stored in a refrigerator or freezer.
Slovenian: Raztopina je namenjena samo za enkratno uporabo in se je ne sme shranjevati v hladilniku ali zmrzovalniku.
English: Children and adolescents Children and adolescents under the age of 18 should not be given Dynastat.
Slovenian: Otroci in mladostniki Otrokom in mladostnikom, mlajšim od 18 let, se zdravila Dynastat ne sme dajati.
English: The carcinogenic potential of parecoxib has not been evaluated.
Slovenian: Karcinogenega potenciala parekoksiba niso ocenili.
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
English: Such effects may occur shortly after treatment initiation and are usually reversible.
Slovenian: Taki učinki se lahko pojavijo kmalu po uvedbi zdravljenja in so običajno reverzibilni.
English: The physician should be prepared to treat severe hypotension.
Slovenian: Zdravnik naj bo pripravljen na zdravljenje hude hipotenzije.
English: All patients received standard of care analgesia during treatment.
Slovenian: Vsi bolniki so med zdravljenjem prejemali standardno analgezijo.
English: It may also play a role in ulcer healing.
Slovenian: Morda igra vlogo tudi pri celjenju ulkusov.
English: Unless such requirements are met, in-storage times and conditions prior to use are the responsibility of the user, and would not normally be longer than 12 hours at 25C.
Slovenian: Če tovrstni pogoji niso izpolnjeni, so čas shranjevanja in pogoji shranjevanja rekonstituirane raztopine pred uporabo odgovornost uporabnika; običajno naj čas ne bi bil daljši od 12 ur pri temperaturi 25 °C.
English: The exact magnitude of the risk associated with a single dose has not been determined, nor has the exact duration of therapy associated with increased risk.
Slovenian: Natančna velikost tveganja, povezanega z uporabo enkratnega odmerka, ni bila ugotovljena, prav tako pa ni bilo ugotovljeno natančno trajanje zdravljenja, ki je povezano s povečanim tveganjem.
English: Your doctor may reduce the dose of Dynastat or other medicines, or you may need to take a different medicine.
Slovenian: Zdravnik bo morda moral zmanjšati odmerek zdravila Dynastat ali drugih zdravil, ali pa boste morali vzeti drugačno zdravilo.
English: Therefore, parecoxib is not recommended in these patients.
Slovenian: Parekoksiba se zato pri tej skupini bolnikov ne priporoča.
English: CABG post-operative safety studies
Slovenian: CABG študije varnosti po operacijah
English: If blood pressure rises significantly, alternative treatment should be considered.
Slovenian: Če krvni tlak občutno naraste, je treba razmisliti o drugih možnostih zdravljenja.
English: Dynastat must be reconstituted before use.
Slovenian: Zdravilo Dynastat je treba pred uporabo rekonstituirati.
English: Dynastat is not recommended in the first 6 months of pregnancy and you must not receive Dynastat in the last three months of pregnancy.
Slovenian: Zdravila Dynastat ni priporočljivo uporabljati v prvih 6 mesecih nosečnosti in zdravila Dynastat ne smete prejeti v zadnjih 3 mesecih nosečnosti.
English: The following solutions cannot be used for reconstitution:
Slovenian: Naslednjih raztopin se za pripravo ne sme uporabljati:
English: The effect of enzyme induction has not been studied.
Slovenian: Učinek indukcije encimov ni raziskan.
English: Do not use this medicine after the expiry date which is stated on the carton and on the vial label after Exp.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki viale poleg oznake »EXP«.
English: For the short-term treatment of postoperative pain in adults.
Slovenian: Za kratkotrajno zdravljenje pooperacijske bolečine pri odraslih.
English: The effects of parecoxib have not been evaluated in late pregnancy or in the pre- and postnatal period.
Slovenian: Učinkov parekoksiba niso ovrednotili v pozni nosečnosti in v pred- ali poporodnem obdobju.
English: The entire contents of the vial should be withdrawn for a single administration.
Slovenian: Za enkratno uporabo je treba izvleči celotno vsebino viale.
English: What Dynastat is and what it is used for
Slovenian: Kaj je zdravilo Dynastat in za kaj ga uporabljamo
English: Other medicines and Dynastat
Slovenian: Druga zdravila in zdravilo Dynastat
English: Two isoforms, COX-1 and COX-2, have been identified.
Slovenian: Znani sta dve izoobliki, COX-1 in COX-2.
English: Pregnant women on NSAIDs should be closely monitored for amniotic fluid volume.
Slovenian: Nosečnice, ki jemljejo NSAID, je treba skrbno spremljati glede volumna amnijske tekočine.
English: The safety and efficacy of parecoxib in children under 18 years old have not been established.
Slovenian: Varnost in učinkovitost parekoksiba pri otrocih, starih do 18 let, nista bili dokazani.
English: Reports from post-marketing experience have been listed as “frequency not known” because the respective frequencies cannot be estimated from the available data.
Slovenian: Poročila iz izkušenj v obdobju trženja zdravila so navedena v rubriki »neznana pogostnost«, saj odgovarjajoče pogostnosti iz razpoložljivih podatkov ni mogoče oceniti.
English: Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis
Slovenian: Stevens-Johnsonov sindrom, multiformni eritem, eksfoliativni dermatitis
English: Data from epidemiological studies suggest an increased risk of miscarriage after use of prostaglandin synthesis inhibitors in early pregnancy.
Slovenian: Podatki iz epidemioloških študij kažejo na večje tveganje za splav po uporabi zaviralcev sinteze prostaglandinov v zgodnji nosečnosti.
English: About 70% of the dose is excreted in the urine as inactive metabolites.
Slovenian: Približno 70 % odmerka se izloči z urinom v obliki neaktivnih presnovkov.
English: Dynastat will be given to you by a doctor or nurse.
Slovenian: Zdravilo Dynastat vam bo dal zdravnik ali medicinska sestra.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali medicinsko sestro, preden vzamete to zdravilo.
English: You will only be given Dynastat for short periods, and only for pain relief.
Slovenian: Zdravilo Dynastat boste dobivali le kratek čas in samo za ublažitev bolečin.
English: Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, Coxibs, ATC code: M01AH04
Slovenian: Farmakoterapevtska skupina: zdravila s protivnetnim in protirevmatičnim učinkom, koksibi, oznaka ATC: M01AH04
English: What you need to know before you use Dynastat
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Dynastat
English: The shelf life of the unreconstituted product is 3 years.
Slovenian: Rok uporabnosti nerekonstituiranega zdravila je 3 leta.
English: Dynastat is used for the short-term treatment of pain in adults after an operation.
Slovenian: Zdravilo Dynastat se uporablja za kratkotrajno zdravljenje bolečin pri odraslih po operaciji.
English: Appropriate measures should be taken by physicians to monitor for any serious skin reactions with therapy, e.g. additional patient consultations.
Slovenian: Zdravniki morajo izvajati ustrezne ukrepe za nadzor kakršnihkoli resnih kožnih reakcij med zdravljenjem, npr. z dodatnimi kontrolami bolnika.
English: Studies in types of surgery other than CABG procedures included patients with American Society of Anaesthesiology (ASA) Physical Status Class I-III only.
Slovenian: Študije drugih tipov operacijskih posegov, razen postopkov CABG, so vključevale le bolnike s kliničnim statusom Ameriškega združenja za anesteziologijo (ASA - American Society of Anaesthesiology), razreda I-III.
English: Higher doses were associated with aggravation and delayed healing of skin infections, an effect probably associated with COX-2 inhibition.
Slovenian: Večji odmerki so bili povezani s poslabšanjem in upočasnjenim zdravljenjem kožnih okužb, kar je verjetno učinek, povezan z zavrtjem COX-2.
English: ▪ If you are breast-feeding, you must not receive Dynastat, as a small amount of Dynastat will be transferred to your breast milk.
Slovenian: • Če dojite, ne smete prejeti zdravila Dynastat, ker lahko majhna količina zdravila Dynastat prehaja v vaše mleko.
English: Do not use Dynastat if you have severe liver disease
Slovenian: Ne uporabljajte zdravila Dynastat, če imate hudo bolezen jeter.
English: Therefore, antiplatelet therapies should not be discontinued (see section 5.1).
Slovenian: Zato antiagregacijskega zdravljenja ne smemo ukiniti (glejte poglavje 5.1).
English: The reconstituted product should be used immediately (up to 24 hours if prepared aseptically), and should not be frozen or refrigerated.
Slovenian: Rekonstituirano zdravilo je treba uporabiti takoj (v roku 24 ur, če je bilo rekonstituirano z uporabo aseptične tehnike) in se ga ne sme zamrzovati ali shranjevati v hladilniku.
English: In the pooled analysis of 676 patients, 318 received placebo and 358 received parecoxib.
Slovenian: V združeni analizi 676 bolnikov je 318 bolnikov dobivalo placebo, 358 bolnikov pa parekoksib.
English: It represents approximately 10% of the concentration of valdecoxib; because of this metabolite's low concentration, it is not expected to contribute a significant clinical effect after administration of therapeutic doses of parecoxib.
Slovenian: Predstavlja približno 10 % koncentracije valdekoksiba; zaradi majhne koncentracije tega presnovka ni pričakovati, da bi imel pri uporabi terapevtskih odmerkov parekoksiba pomemben klinični učinek.
English: Your doctor may want to monitor your blood pressure during treatment with Dynastat.
Slovenian: Vaš zdravnik bo med zdravljenjem z zdravilom Dynastat morda želel nadzirati vaš krvni tlak.
English: The decision to prescribe a selective cyclooxygenase-2 (COX-2) inhibitor should be based on an assessment of the individual patient's overall risks (see sections 4.3 and 4.4).
Slovenian: Odločitev, da se predpiše selektivni zaviralec ciklooksigenaze-2 (COX-2), mora temeljiti na oceni vseh tveganj za vsakega posameznega bolnika (glejte poglavji 4.3 in 4.4).
English: Most trials were designed for dosing of parecoxib up to 3 days.
Slovenian: Večino preskušanj so zasnovali za do 3-dnevno odmerjanje parekoksiba.
English: However, inhibition of prostaglandin synthesis might adversely affect pregnancy.
Slovenian: Vendar pa lahko zaviranje sinteze prostagladinov neugodno vpliva na nosečnost.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino ali katerokoli pomožno snov navedeno v poglavju 6.1.
English: Opioid analgesics can be used concurrently with parecoxib, dosing as described in the paragraph above.
Slovenian: Opioidne analgetike lahko uporabljamo hkrati s parekoksibom, odmerjanje pa mora biti takšno, kot je opisano v zgornjem odstavku.
English: Parecoxib has been used in a range of major and minor surgeries.
Slovenian: Parekoksib so uporabili pri različnih večjih in manjših kirurških posegih.
English: The IM injection should be given slowly and deeply into the muscle.
Slovenian: Intramuskularno injekcijo je treba dajati počasi in globoko v mišico.
English: It is recommended that Dynastat is used as soon as possible after it is mixed with solvent, although it may be stored if the instructions at the end of the leaflet are strictly followed.
Slovenian: Priporočljivo je, da se rekonstituirano raztopino zdravila Dynastat uporabi čimprej po mešanju praška z vehiklom; vendar pa se raztopino lahko shranjuje, če se strogo upošteva navodila, ki so navedena na koncu tega navodila.
English: The third trimester of pregnancy and breast-feeding (see sections 4.6 and 5.3).
Slovenian: Tretje trimesečje nosečnosti in obdobje dojenja (glejte poglavji 4.6 in 5.3).
English: For more information on storage see the package leaflet.
Slovenian: Za več podatkov o shranjevanju glejte navodilo za uporabo.
English: In case of overdose, patients should be managed by symptomatic and supportive care.
Slovenian: V primeru prevelikega odmerjanja je potrebno simptomatsko in podporno zdravljenje.
English: Chemical and physical in-use stability of the reconstituted solution, which should not be refrigerated or frozen, have been demonstrated for up to 24 hours at 25C.
Slovenian: Kemična in fizikalna stabilnost rekonstituirane raztopine, ki je ne smemo shranjevati v hladilniku ali zamrzovati, sta dokazani za obdobje do 24 ur pri temperaturi 25 °C.
English: NSAID use during the second or third trimester of pregnancy may cause foetal renal dysfunction which may result in reduction of amniotic fluid volume or oligohydramnios in severe cases.
Slovenian: Uporaba NSAID v drugem in tretjem trimesečju nosečnosti lahko pri plodu povzroči motnjo delovanja ledvic, kar lahko privede do zmanjšanja volumna amnijske tekočine ali oligohidramnija pri hudih primerih.
English: In this case, it is advisable to rehydrate patients first and then start therapy with Dynastat.
Slovenian: Te bolnike je priporočljivo najprej rehidrirati in šele nato začeti zdravljenje z zdravilom Dynastat.
English: Dynastat should be administered within 24 hours of reconstitution (see section 6.3), or discarded.
Slovenian: Zdravilo Dynastat je treba uporabiti v 24 urah po rekonstituciji (glejte poglavje 6.3) ali pa ga zavreči.
English: The injection may be given rapidly and directly into a vein or into an existing intravenous line (a thin tube running into a vein), or it can be given slowly and deeply into a muscle.
Slovenian: Injekcijo se lahko da hitro in neposredno v veno ali v že napeljano intravensko pot (tanko cevko, ki teče v veno), lahko pa se jo da počasi in globoko v mišico.
English: If there are particles in the injection solution or if either the powder or solution is discoloured, the solution will not be used.
Slovenian: Če so v raztopini za injiciranje delci ali sta prašek ali raztopina obarvana, raztopina ne bo uporabljena.
English: Use with oral anticoagulants
Slovenian: Uporaba s peroralnimi antikoagulanti
English: The usual dose to start with is 40 mg. You may be given another dose - either 20 mg or 40 mg - 6 to 12 hours after the first one.
Slovenian: Običajni začetni odmerek je 40 mg. Dodaten odmerek - 20 ali 40 mg - lahko prejmete od 6 do 12 ur po prvem.
English: Myocardial infarction, bradycardia
Slovenian: Miokardni infarkt, bradikardija
English: Patients should be advised to immediately report any emergent skin condition to their physician.
Slovenian: Bolnikom je treba naročiti, da morajo o vsaki novonastali kožni spremembi takoj obvestiti zdravnika.
English: The volume of distribution of valdecoxib after its IV administration is approximately 55 litres.
Slovenian: Volumen porazdelitve valdekoksiba po intravenski uporabi je približno 55 litrov.
English: If the injection makes you feel dizzy or tired, do not drive or use machines until you feel better again.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Če ste po injekciji omotični ali utrujeni, ne vozite in ne upravljajte strojev, dokler se ne počutite bolje.
English: Use of parecoxib beyond 3 days
Slovenian: Uporaba parekoksiba, daljša od 3 dni
English: Dynastat has been administered to 335 elderly patients (65-96 years of age) in pharmacokinetic and therapeutic trials.
Slovenian: Zdravilo Dynastat so v farmakokinetičnih in terapevtskih študijah dajali 335 starejšim bolnikom (starim od 65 do 96 let).
English: If Dynastat is used with strong pain killers (called opioid analgesics) such as morphine the dose of Dynastat will be the same as explained above.
Slovenian: Če zdravilo Dynastat uporabite sočasno z močnimi zdravili proti bolečinam (imenovanimi opioidni analgetiki), kot je npr. morfin, je odmerek zdravila Dynastat enak kot je obrazloženo zgoraj.
English: Therefore, the concomitant administration of these drugs should be done with caution.
Slovenian: Pri sočasni uporabi navedenih zdravil je zato potrebna previdnost.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila glede rekonstitucije zdravila pred uporabo glejte poglavje 6.6.
English: Solvent ampoules 2 ml ampoule: colourless neutral glass, Type I.
Slovenian: Ampule vehikla 2 ml ampula: brezbarvno naravno steklo, tip I.
English: Concomitant use with opioid analgesics
Slovenian: Sočasna uporaba opioidnih analgetikov
English: Manufacturer: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium
Slovenian: Izdelovalec: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgija
English: If, during treatment, patients deteriorate in any of the organ system functions described below, appropriate measures should be taken and discontinuation of parecoxib therapy should be considered.
Slovenian: Če se med zdravljenjem poslabša delovanje kateregakoli organskega sistema, opisanega spodaj, je treba izvesti ustrezne ukrepe in razmisliti o ukinitvi zdravljenja s parekoksibom.
English: The concomitant use of NSAIDs with oral anticoagulants increases the risk of bleeding.
Slovenian: Sočasna uporaba nesteroidnih protivnetnih zdravil in peroralnih antikoagulantov poveča tveganje za krvavitve.
English: Data from 3 randomised placebo-controlled trials, where the protocols allowed treatment of parecoxib for >3 days was pooled and analysed.
Slovenian: Podatke iz 3 randomiziranih, s placebom nadzorovanih preskušanj, katerih protokoli so dopuščali več kot 3-dnevno zdravljenje s parekoksibom, so združili in analizirali.
English: If there is clinical evidence of deterioration in the condition of these patients, appropriate measures including discontinuation of parecoxib should be taken.
Slovenian: Če obstajajo klinični dokazi za poslabšanje stanja teh bolnikov, je treba izvesti ustrezne ukrepe, vključno s prekinitvijo zdravljenja s parekoksibom.
English: Coadministration of parecoxib and heparin did not affect the pharmacodynamics of heparin (activated partial thromboplastin time) compared to heparin alone.
Slovenian: Sočasna uporaba parekoksiba in heparina ni vplivala na farmakodinamiko heparina (aktivirani delni tromboplastinski čas) v primerjavi z dajanjem samega heparina.
English: Patients who experience dizziness, vertigo or somnolence after receiving Dynastat should refrain from driving or operating machines.
Slovenian: Bolniki, pri katerih se po prejemu zdravila Dynastat pojavijo omotica, vrtoglavica ali zaspanost, ne smejo voziti ali upravljati strojev.
English: Administration of a single dose of parecoxib to lactating women following caesarean section resulted in the transfer of a relatively small amount of parecoxib and its active metabolite valdecoxib into human milk, and this resulted in a low relative dose for the infant (approximately 1% of the weight-adjusted maternal dose).
Slovenian: Dajanje enkratnega odmerka parekoksiba doječim ženskam po carskem rezu je imelo za posledico prenos relativno majhne količine parekoksiba in njegovega aktivnega presnovka valdekoksiba v materino mleko in posledično nizek relativen odmerek za dojenčka (približno 1 % materinega odmerka, prilagojenega na telesno maso).
English: However, due to the importance of microbiological infection risk for injectable products, the reconstituted solution should be used immediately unless reconstitution has taken place in controlled and validated aseptic conditions.
Slovenian: Vendar pa je treba zaradi tveganja mikrobiološke okužbe pri zdravilih za injiciranje rekonstituirano raztopino uporabiti takoj, razen če je rekonstitucija potekala v nadzorovanih in preverjenih aseptičnih pogojih.
English: Parecoxib is rapidly and almost completely converted to valdecoxib and propionic acid in vivo with a plasma half-life of approximately 22 minutes.
Slovenian: Parekoksib se in vivo hitro in skoraj popolnoma pretvori v valdekoksib in propionsko kislino s plazemskim razpolovnim časom približno 22 minut.
English: Clinical trials indicate that Dynastat can be given with low dose acetylsalicylic acid ( 325 mg).
Slovenian: Klinične študije kažejo, da je zdravilo Dynastat mogoče uporabljati hkrati z majhnim odmerkom acetilsalicilne kisline (≤ 325 mg).
English: In healthy elderly subjects, the apparent oral clearance of valdecoxib was reduced, resulting in an approximately 40% higher plasma exposure of valdecoxib compared to healthy young subjects.
Slovenian: Pri zdravih starejših preskušancih je bil navidezni peroralni očistek valdekoksiba zmanjšan, kar je povzročilo približno 40 % večjo plazemsko izpostavljenost valdekoksibu kot pri zdravih mladih preskušancih.
English: Chemical and physical in-use stability of the reconstituted solution have been demonstrated for up to 24 hours at 25C.
Slovenian: Kemična in fizikalna stabilnost rekonstituirane raztopine sta dokazani za obdobje do 24 ur pri temperaturi 25 °C.
English: Of the patients treated with parecoxib, 317 patients received parecoxib for up to 4 days, 32 patients for up to 5 days, while only 8 patients were treated for up to 6 days and 1 patient for 7 or more days.
Slovenian: Med bolniki, ki so jih zdravili s parekoksibom, je 317 bolnikov dobivalo parekoksib do 4 dni, 32 bolnikov do 5 dni, le 8 bolnikov pa so zdravili do 6 dni in 1 bolnika 7 dni ali več.
English: Cerebrovascular disorder
Slovenian: Cerebrovaskularne motnje
English: COX-2 selective inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane.
Slovenian: Selektivni zaviralci COX-2 zmanjšujejo tvorbo sistemskega (in s tem morda tudi endotelijskega) prostaciklina, ne da bi vplivali na trombocitni tromboksan.
English: In all clinical assessments parecoxib was administered at a fixed time interval whereas the opioids were administered on as needed basis.
Slovenian: V vseh kliničnih ocenjevanjih so parekoksib uporabljali v določenih časovnih presledkih, opioide pa po potrebi.
English: COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established.
Slovenian: Pri človeku so COX-2 odkrili v tkivu okoli želodčnih razjed, vendar njen pomen za celjenje razjed ni znan.
English: The injection solution should be a clear colourless liquid.
Slovenian: Raztopina za injiciranje mora biti bistra, brezbarvna tekočina.
English: The first perceptible analgesic effect occurred in 7-13 minutes, with clinically meaningful analgesia demonstrated in 23-39 minutes and a peak effect within 2 hours following administration of single doses of 40 mg IV or IM Dynastat.
Slovenian: Prvi zaznavni analgetični učinek se je pojavil po 7 do 13 minutah, klinično pomembna analgezija pa je bila dokazana po 23 do 39 minutah, z največjim učinkom v 2 urah po uporabi enkratnih odmerkov 40 mg zdravila Dynastat intravensko ali intramuskularno.
English: How to use Dynastat
Slovenian: Kako uporabljati zdravilo Dynastat