FrancophonIA/ELRC3.0 huggingface dataset:
English: Dynastat is available in packs containing 10 vials.
Croatian: Dynastat je dostupan u pakiranjima od 10 bočica.
English: ▪ If you are breast-feeding, you must not receive Dynastat, as a small amount of Dynastat will be transferred to your breast milk.
Croatian: • Ako dojite, ne smijete primati Dynastat jer će mala količina Dynastata prijeći u majčino mlijeko.
English: Active peptic ulceration or gastrointestinal (GI) bleeding.
Croatian: Aktivni peptički ulkus ili gastrointestinalno (GI) krvarenje.
English: What Dynastat is and what it is used for What you need to know before you use Dynastat How to use Dynastat
Croatian: Što je Dynastat i za što se koristi Što morate znati prije nego počnete primjenjivati Dynastat Kako primjenjivati Dynastat
English: Patients appear to be at highest risk for these reactions early in the course of therapy; the onset of the reaction occurring in the majority of cases within the first month of treatment.
Croatian: Čini se da je rizik od ovakvih reakcija u bolesnika najveći na početku terapije; reakcija se u većini slučajeva javlja u prvom mjesecu liječenja.
English: If blood pressure rises significantly, alternative treatment should be considered.
Croatian: Ako se krvni tlak značajno povisi, potrebno je razmotriti druge načine liječenja.
English: The third trimester of pregnancy and breast-feeding (see sections 4.6 and 5.3).
Croatian: Treće tromjesečje trudnoće i dojenje (vidjeti dijelove 4.6 i 5.3).
English: It may also play a role in ulcer healing.
Croatian: Također može igrati ulogu u cijeljenju ulkusa.
English: Cyclooxygenase is responsible for generation of prostaglandins.
Croatian: Ciklooksigenaza je odgovorna za stvaranje prostaglandina.
English: Use with oral anticoagulants
Croatian: Primjena s oralnim antikoagulansima
English: The shelf life of the unreconstituted product is 3 years.
Croatian: Rok valjanosti nerekonstituiranog lijeka je 3 godine.
English: What you need to know before you use Dynastat
Croatian: Što morate znati prije nego počnete primjenjivati Dynastat
English: Clinical trials indicate that Dynastat can be given with low dose acetylsalicylic acid ( 325 mg).
Croatian: Klinička ispitivanja pokazuju da se Dynastat može primijeniti s niskom dozom acetilsalicilne kiseline ( 325 mg).
English: Patients without a history of sulfonamide allergy may also be at risk for serious skin reactions.
Croatian: Bolesnici koji u povijesti bolesti nemaju alergiju na sulfonamide također mogu biti u riziku od ozbiljnih kožnih reakcija.
English: In this case, it is advisable to rehydrate patients first and then start therapy with Dynastat.
Croatian: U tom se slučaju savjetuje prvo rehidrirati bolesnike, a potom započeti terapiju Dynastatom.
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.
Croatian: Ako ovi uvjeti nisu zadovoljeni, vrijeme i uvjeti čuvanja prije primjene odgovornost su korisnika i obično ne bi trebali iznositi dulje od 12 sati na temperaturi od 25C.
English: Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis
Croatian: Stevens-Johnsonov sindrom, multiformni eritem, eksfolijativni dermatitis
English: Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Croatian: Ustanovljena ishemijska bolest srca, periferna arterijska bolest i/ili cerebrovaskularna bolest.
English: For the short-term treatment of postoperative pain in adults.
Croatian: Za kratkotrajno liječenje poslijeoperacijske boli u odraslih.
English: Dynastat should be administered within 24 hours of reconstitution (see section 6.3), or discarded.
Croatian: Dynastat se mora primijeniti u roku od 24 sata po rekonstituciji (vidjeti dio 6.3) ili baciti.
English: The volume of distribution of valdecoxib after its IV administration is approximately 55 litres.
Croatian: Volumen distribucije valdekoksiba nakon i.v. primjene iznosi približno 55 litara.
English: About 70% of the dose is excreted in the urine as inactive metabolites.
Croatian: Oko 70% doze izluči se u mokraći u obliku inaktivnih metabolita.
English: Dynastat is used for the short-term treatment of pain in adults after an operation.
Croatian: Dynastat se primjenjuje za kratkotrajno liječenje boli u odraslih nakon operacije.
English: Thus, 24 hours should be considered the maximum shelf life of the reconstituted product.
Croatian: Stoga se 24 sata mora smatrati maksimalnim rokom valjanosti rekonstituiranog lijeka.
English: Blood pressure should be monitored closely during the initiation of therapy with parecoxib and throughout the course of therapy.
Croatian: Krvni se tlak mora pažljivo nadzirati tijekom početka terapije parekoksibom, kao i tijekom cijelog trajanja terapije.
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.
Croatian: On čini približno 10% koncentracije valdekoksiba, no zbog niske koncentracije tog metabolita, ne očekuje se da će značajno pridonijeti kliničkom učinku parekoksiba nakon primjene u terapijskim dozama.
English: COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established.
Croatian: COX-2 identificiran je u tkivima oko želučanog ulkusa u čovjeka, ali njegova važnost za cijeljenje ulkusa još nije ustanovljena.
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.
Croatian: Ako se Dynastat primjenjuje s jakim lijekovima protiv boli (koji se zovu opioidni analgetici) kao što je morfij doza Dynastata bit će ista kao što je objašnjeno gore.
English: The solution is for single use only and must not be stored in a refrigerator or freezer.
Croatian: Otopina je samo za jednokratnu primjenu i ne smije se čuvati u hladnjaku niti zamrzavati.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology or repeated dose toxicity at 2-fold the maximum human exposure to parecoxib.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije ili toksičnosti ponovljenih doza pri izloženosti parekoksibu koja je dvostruko veća od one maksimalne u ljudi.
English: Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, Coxibs, ATC code: M01AH04
Croatian: Farmakoterapijska skupina: protuupalni i antireumatski lijekovi, koksibi, ATK oznaka: M01AH04
English: Appropriate measures should be taken by physicians to monitor for any serious skin reactions with therapy, e.g. additional patient consultations.
Croatian: Liječnici moraju poduzeti odgovarajuće mjere kako bi nadzirali sve ozbiljne kožne reakcije na terapiju, npr. dodatne posjete bolesnika.
English: The effects of parecoxib have not been evaluated in late pregnancy or in the pre- and postnatal period.
Croatian: Nisu procijenjeni učinci parekoksiba u kasnoj trudnoći niti u prenatalnom i postnatalnom razdoblju.
English: Higher doses were associated with aggravation and delayed healing of skin infections, an effect probably associated with COX-2 inhibition.
Croatian: Više doze bile su povezane s pogoršanjem ili usporenim cijeljenjem kožnih infekcija, što je učinak vjerojatno povezan s inhibicijom COX-2.
English: Reports from post-marketing experience have been listed as “frequency not known” because the respective frequencies cannot be estimated from the available data.
Croatian: Prijave iz iskustva nakon stavljanja lijeka u promet navedene su kao “nepoznata učestalost” zato što se njihova učestalost ne može procijeniti iz dostupnih podataka.
English: Dynastat and opioids should not be administered together in the same syringe.
Croatian: Dynastat i opioidi ne smiju se primjenjivati zajedno u istoj štrcaljki.
English: The concomitant use of NSAIDs with oral anticoagulants increases the risk of bleeding.
Croatian: Istodobna primjena nesteroidnih protuupalnih lijekova s oralnim antikoagulansima povećava rizik od krvarenja.
English: The injection solution should be a clear colourless liquid.
Croatian: Otopina za injekciju mora biti bistra, bezbojna tekućina.
English: In case of overdose, patients should be managed by symptomatic and supportive care.
Croatian: U slučaju predoziranja bolesnike se mora liječiti simptomatski i potpornim mjerama.
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.
Croatian: Injekcija se može dati brzo i izravno u venu ili u već postavljenu intravensku liniju (tanka cjevčica uvedena u venu), ili se može dati sporo i duboko u mišić.
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).
Croatian: Odluka da se propiše selektivni inhibitor ciklooksigenaze-2 (COX-2) mora se temeljiti na procjeni ukupnog rizika u pojedinog bolesnika (vidjeti dijelove 4.3 i 4.4).
English: Data from epidemiological studies suggest an increased risk of miscarriage after use of prostaglandin synthesis inhibitors in early pregnancy.
Croatian: Podaci iz epidemioloških studija ukazuju na povećani rizik od spontanog pobačaja nakon primjene inhibitora sinteze prostaglandina u ranoj trudnoći.
English: Dynastat is contraindicated in the third trimester of pregnancy (see section 4.3).
Croatian: Dynastat je kontraindiciran u trećem tromjesečju trudnoće (vidjeti dio 4.3).
English: Aseptic technique is required for its preparation.
Croatian: Za pripremu je potrebno koristiti aseptičnu tehniku.
English: Additional studies in other surgical settings provided similar observations.
Croatian: Dodatna ispitivanja primjene kod drugih vrsta operacija dovela su do sličnih opažanja.
English: Dynastat must be reconstituted before use.
Croatian: Dynastat se prije primjene mora rekonstituirati.
English: Coadministration of parecoxib and heparin did not affect the pharmacodynamics of heparin (activated partial thromboplastin time) compared to heparin alone.
Croatian: Istodobna primjena parekoksiba i heparina nije utjecala na farmakodinamiku heparina (aktivirano parcijalno tromboplastinsko vrijeme) u usporedbi sa samo heparinom.
English: Therefore, antiplatelet therapies should not be discontinued (see section 5.1).
Croatian: Stoga se ne smije prekinuti primjena antitrombocitne terapije (vidjeti dio 5.1).
English: The following adverse reactions were reported for patients who received parecoxib (N=5,402) in 28 placebo-controlled clinical trials.
Croatian: Sljedeće nuspojave zabilježene su u bolesnika koji su primali parekoksib (N=5402) u 28 placebom kontroliranih kliničkih ispitivanja.
English: Dynastat can lead to an increase in blood pressure or worsening of existing high blood pressure which may result in an increase in side-effects associated with heart conditions.
Croatian: Dynastat može dovesti do povećanja krvnog tlaka ili pogoršanja već povišenog krvnog tlaka, što može rezultirali povećanjem nuspojava povezanih sa srčanim stanjima.
English: 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).
Croatian: COX-2 također je uključen u ovulaciju, implantaciju i zatvaranje ductus arteriosusa, regulaciju funkcije bubrega i funkcije središnjeg živčanog sustava (indukcija vrućice, percepcija boli i kognitivne funkcije).
English: Diuresis or alkalisation of urine may not be useful due to high protein binding of valdecoxib.
Croatian: Diureza ili alkalizacija mokraće možda neće biti korisne zbog velike sposobnosti vezanja valdekoksiba za proteine.
English: Within each frequency grouping, adverse reactions are listed using MedDRA terminology and presented in order of decreasing seriousness.
Croatian: Unutar svake skupine po učestalosti, nuspojave su navedene prema MedDRA terminologiji i prikazane u padajućem nizu prema ozbiljnosti.
English: These results indicate that although valdecoxib is not metabolised by CYP2C19, it may be an inhibitor of this isoenzyme.
Croatian: Ovi rezultati pokazuju da, iako se valdekoksib ne metabolizira putem CYP2C19, on može inhibirati taj izoenzim.
English: Patients who experience dizziness, vertigo or somnolence after receiving Dynastat should refrain from driving or operating machines.
Croatian: Bolesnici koji razviju omaglicu, vrtoglavicu ili somnolenciju nakon primanja Dynastata moraju se suzdržati od upravljanja vozilima i rada sa strojevima.
English: Lithium serum concentration should be monitored closely when initiating or changing parecoxib therapy in patients receiving lithium.
Croatian: Serumske koncentracije litija treba pažljivo pratiti kad se započinje ili mijenja terapija parekoksibom u bolesnika koji primaju litij.
English: Pre-specified events that occurred with the highest incidence in all three treatment groups involved the category of surgical wound complications, including deep surgical infections and sternal wound healing events.
Croatian: Unaprijed definirani događaji koji su se dogodili najvišom incidencijom u sve tri terapijske skupine uključivali su kategoriju komplikacija kirurške rane, uključujući duboke kirurške infekcije i poremećeno cijeljenje sternalne rane.
English: Opioid analgesics can be used concurrently with parecoxib, dosing as described in the paragraph above.
Croatian: Opioidni analgetici mogu se primjenjivati istodobno s parekoksibom, doziranje kao što je opisano u prethodnom odlomku.
English: When adjusted for body weight, steady state plasma exposure of valdecoxib was 16% higher in elderly females compared to elderly males (see section 4.2).
Croatian: Nakon prilagodbe prema tjelesnoj težini, izloženost valdekoksibu u plazmi u stanju dinamičke ravnoteže bila je 16% viša u starijih žena u usporedbi sa starijim muškarcima (vidjeti dio 4.2).
English: Parecoxib is rapidly and almost completely converted to valdecoxib and propionic acid in vivo with a plasma half-life of approximately 22 minutes.
Croatian: Parekoksib se brzo i gotovo potpuno konvertira u valdekoksib i propionsku kiselinu in vivo uz poluvijek u plazmi od približno 22 minute.
English: In the pooled analysis of 676 patients, 318 received placebo and 358 received parecoxib.
Croatian: U objedinjenoj analizi 676 bolesnika, 318 bolesnika primalo je placebo, dok je 358 bolesnika primalo parekoksib.
English: The IM injection should be given slowly and deeply into the muscle.
Croatian: Intramuskularnu injekciju mora se dati sporo i duboko u mišić.
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.
Croatian: Međutim, zbog važnosti rizika od mikrobiološke infekcije lijekovima koji se injiciraju, rekonstituirana otopina mora se odmah primijeniti osim ako se rekonstitucija nije provela u kontroliranim i validiranim aseptičkim uvjetima.
English: Parecoxib should be discontinued at the first sign of hypersensitivity.
Croatian: Parekoksib se mora prekinuti kod prvog znaka preosjetljivosti.
English: PFIZER ΕΛΛΑΣ Α.Ε.
Croatian: PFIZER ΕΛΛΑΣ A.E.
English: However, in the repeated dose toxicity studies in dogs and rats, the systemic exposures to valdecoxib (the active metabolite of parecoxib) were approximately 0.8-fold the systemic exposure in elderly human subjects at the maximum recommended therapeutic dose of 80 mg daily.
Croatian: Međutim, u ispitivanjima toksičnosti ponovljenih doza u pasa i štakora, sistemska izloženost valdekoksibu (djelatnom metabolitu parekoksiba) iznosila je približno 0,8 sistemske izloženosti u starijih ljudskih ispitanika pri maksimalnoj preporučenoj terapijskoj dozi od 80 mg dnevno.
English: Patients should be advised to immediately report any emergent skin condition to their physician.
Croatian: Bolesnike se mora savjetovati da svom liječniku odmah prijave pojavu bilo kakve iznenadne kožne promjene.
English: The following solutions cannot be used for reconstitution:
Croatian: Sljedeće otopine ne smiju se koristiti za rekonstituciju lijeka:
English: During the first and second trimester of pregnancy, Dynastat should not be given unless clearly necessary.
Croatian: Dynastat se ne smije primjenjivati u prvom i drugom tromjesečju trudnoće, osim kad za time postoji jasna potreba.
English: Added pain relief compared to opioids alone was shown.
Croatian: Pokazalo se da postoji dodatno ublažavanje boli u usporedbi sa samo opioidima.
English: Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with parecoxib after careful consideration (see section 5.1).
Croatian: Bolesnici sa značajnim čimbenicima rizika za kardiovaskularni događaj (npr. hipertenzijom, hiperlipidemijom, šećernom bolešću, pušenjem) smiju se liječiti parekoksibom tek nakon pažljivog razmatranja (vidjeti dio 5.1).
English: Effect of parecoxib (or its active metabolite valdecoxib) on the pharmacokinetics of other medicinal products
Croatian: Učinak parekoksiba (ili njegovog djelatnog metabolita valdekoksiba) na farmakokinetiku drugih lijekova
English: Placebo/valdecoxib treatment was also associated with a higher incidence of CV thromboembolic events versus placebo treatment, but this difference did not reach statistical significance.
Croatian: Liječenje placebom/valdekoksibom također je bilo povezano s većom incidencijom kardiovaskularnih tromboembolijskih događaja naspram liječenja placebom, ali razlika nije dosegla statističku značajnost.
English: Reconstitution solvents Acceptable solvents for reconstitution of Dynastat are:
Croatian: Otapala za rekonstituciju Prihvatljiva otapala za rekonstituciju Dynastata su:
English: The most common adverse reaction for Dynastat is nausea.
Croatian: Najčešća nuspojava Dynastata je mučnina.
English: Surgical wound complications (most involving the sternal wound) were observed at an increased rate with parecoxib/valdecoxib treatment.
Croatian: Komplikacije kirurške rane (većinom sternalne rane) bile su opažene u povećanoj stopi uz liječenje parekoksibom/valdekoksibom.
English: After reconstitution, the liquid should be a clear solution.
Croatian: Nakon rekonstitucije, tekućina mora biti bistra otopina.
English: In short-term studies (7 days), the incidence of endoscopically observed gastroduodenal ulcers or erosions in healthy young and elderly ( 65 years) subjects administered Dynastat (5-21%), although higher than placebo (5-12%), was statistically significantly lower than the incidence observed with NSAIDs (66-90%).
Croatian: U kratkotrajnim ispitivanjima (7 dana) incidencija endoskopski opaženih gastroduodenalnih ulkusa ili erozija u zdravih mladih i starijih ( 65 godina) ispitanika kojima se primjenjivao Dynastat (5-21%), iako viša nego uz placebo (5-12%), bila je statistički značajno niža od incidencije opažene uz nesteroidne protuupalne lijekove (66-90%).
English: There are no adequate data from the use of parecoxib in pregnant women or during labour.
Croatian: Nema odgovarajućih podataka o primjeni parekoksiba u trudnica ili tijekom porođaja.
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.
Croatian: Preporučuje se primijeniti Dynastat što prije nakon miješanja s otapalom, iako ga se može čuvati ako se strogo pridržavate uputa na kraju Upute.
English: In reproduction toxicity tests, the incidence of post-implantation losses, resorptions and foetal body weight retardation occurred at doses not producing maternal toxicity in the rabbit studies.
Croatian: U testovima reproduktivne toksičnosti, incidencija postimplantacijskih gubitaka, resorpcije i smanjene fetalne tjelesne težine nastupila je pri dozama koje nisu bile toksične za majke u ispitivanjima na kunićima.
English: If you are given more Dynastat than you should you may experience side-effects that have been reported with recommended doses.
Croatian: Ako ste dobili više Dynastata nego što ste smjeli možete osjetiti nuspojave koje su opisane za preporučene doze.
English: Three of the six cardiovascular thromboembolic events in the placebo/valdecoxib treatment group occurred during the placebo treatment period; these patients did not receive valdecoxib.
Croatian: Tri od šest kardiovaskularnih tromboembolijskih događaja u skupini koja je primala placebo/valdekoksib nastalo je tijekom razdoblja primjene placeba; ovi bolesnici nisu dobili valdekoksib.
English: Valdecoxib is a selective COX-2 inhibitor within the clinical dose range.
Croatian: Valdekoksib je selektivni inhibitor COX-2 unutar kliničkog raspona doza.
English: Parecoxib should be used with caution in patients with hypertension.
Croatian: Parekoksib se mora primjenjivati s oprezom u bolesnika s hipertenzijom.
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.
Croatian: Ako se tijekom liječenja bolesniku pogorša funkcija bilo kojeg organskog sustava, kako je opisano u nastavku, moraju se primijeniti odgovarajuće mjere i razmotriti prekid terapije parekoksibom.
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.
Croatian: U zdravih starijih ispitanika, vidljivi oralni klirens valdekoksiba bio je smanjen, što je dovelo do približno 40% veće izloženosti valdekoksibu u plazmi u usporedbi s onom u zdravih mladih ispitanika.
English: Steady state plasma concentrations of valdecoxib were reached within 4 days with twice daily dosing.
Croatian: Stanja dinamičke ravnoteže koncentracija valdekoksiba u plazmi bila su postignuta u roku od 4 dana uz doziranje dvaput dnevno.
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.
Croatian: Primjena nesteroidnih protuupalnih lijekova tijekom drugog ili trećeg tromjesečja trudnoće može uzrokovati fetalni poremećaj funkcije bubrega koji može dovesti do smanjenja plodne vode ili oligohidramnija u teškim slučajevima.
English: The use of Dynastat, as with any medicinal product known to inhibit cyclooxygenase/prostaglandin synthesis, is not recommended in women attempting to conceive (see sections 4.3, 5.1 and 5.3).
Croatian: Primjena Dynastata, kao i bilo kojeg drugog lijeka za koji se zna da inhibira ciklooksigenazu/sintezu prostaglandina, ne preporučuje se u žena koje pokušavaju začeti (vidjeti dijelove 4.3, 5.1 i 5.3).
English: Reconstitution solvents This medicinal product must not be mixed with other medicinal products.
Croatian: Ovaj lijek ne smije se miješati s drugim lijekovima.
English: COX-2 inhibitors have been associated with increased risk of cardiovascular and thrombotic adverse events when taken long term.
Croatian: Inhibitori COX-2 povezani su s povećanim rizikom od kardiovaskularnih i trombotičkih štetnih događaja kad se uzimaju dulje vrijeme.
English: History of previous serious allergic drug reaction of any type, especially cutaneous reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme or patients with known hypersensitivity to sulfonamides (see sections 4.4 and 4.8).
Croatian: Prethodne ozbiljne alergijske reakcije na lijek bilo kojeg tipa, osobito kožne reakcije kao što su Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, multiformni eritem ili bolesnici s poznatom preosjetljivošću na sulfonamide (vidjeti dijelove 4.4 i 4.8).
English: Dynastat may mask fever and other signs of inflammation (see section 5.1).
Croatian: Dynastat može prikriti vrućicu i druge znakove upale (vidjeti dio 5.1).