natgillin/translations-raw huggingface dataset:
As the cardiovascular risk of COX-2 specific inhibitors may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.
Kardiovaskularno tveganje zaradi specifičnih zaviralcev COX-2 se pri večjih odmerkih in daljši izpostavljenosti lahko poveča, zato mora biti zdravljenje čim krajše in z najmanjšim učinkovitim dnevnim odmerkom.
However caution is advised when methotrexate is administered concurrently with NSAIDs, because NSAID administration may result in increased plasma levels of methotrexate.
Kljub temu je priporočljiva previdnost pri sočasni uporabi metotreksata z nesteroidnimi protivnetnimi zdravili, ker lahko dajanje le-teh privede do zvišanih koncentracij metotreksata v plazmi.
Dynastat is supplied as a sterile, single unit-of-use vial that is packaged with a 2 ml ampoule with a fill volume of 2 ml sodium chloride 9 mg/ml (0.9%) solution (see below for various pack sizes and configurations)
Zdravilo Dynastat je na voljo v obliki sterilne viale za enkratno uporabo, skupaj z 2 ml ampulo s polnitveno prostornino 2 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) (glejte spodaj za različna pakiranja).
Diuresis or alkalisation of urine may not be useful due to high protein binding of valdecoxib.
Diureza ali alkalizacija urina sta vprašljiva ukrepa, ker je valdekoksib v veliki meri vezan na beljakovine.
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.
Trije od šestih kardioavskularnih/trombemboličnih dogodkov pri skupini, ki je prejemala placebo/valdekoksib, so se pojavili med prejemanjem placeba.
Coadministration of NSAIDs and ciclosporin or tacrolimus has been suggested to increase the nephrotoxic effect of ciclosporin and tacrolimus because of NSAID effects on renal prostaglandins.
Sočasna uporaba nesteroidnih protivnetnih zdravil in ciklosporina ali takrolimusa naj bi povečala nefrotoksični učinek ciklosporina in takrolimusa zaradi učinka nesteroidnih protivnetnih zdravil na ledvične prostaglandine.
Anticoagulant therapy should be monitored, particularly during the first few days after initiating Dynastat therapy in patients receiving warfarin or other anticoagulants, since these patients have an increased risk of bleeding complications.
Pri bolnikih, ki prejemajo varfarin ali druge antikoagulante, je treba nadzirati antikoagulantno zdravljenje, zlasti v prvih nekaj dneh po uvedbi zdravila Dynastat, saj imajo ti bolniki povečano tveganje za hemoragične zaplete.
These decreases were not considered clinically important since Cmax of valdecoxib is comparable after IM and IV parecoxib administration.
Tega zmanjšanja niso ocenili za klinično pomembnega, ker je Cmax valdekoksiba po i.m.
COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
COX-2 je izooblika encima, za katero je dokazano, da jo inducirajo provnetni dražljaji; domnevno je ta izooblika odgovorna za sintezo prostanoidnih mediatorjev bolečine, vnetja in zvišane telesne temperature.
These results indicate that although valdecoxib is not metabolised by CYP2C19, it may be an inhibitor of this isoenzyme.
To kaže, da valdekoksib lahko zavira CYP2C19, čeprav se ne presnavlja s pomočjo tega izoencima.
In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors or Angiotensin-II antagonists, may result in further deterioration of renal function, including possible acute renal failure.
Pri starejših bolnikih s hipovolemijo (vključno s tistimi, ki se zdravijo z diuretiki), ali z zmanjšanim delovanjem ledvic, lahko sočasna uporaba nesteroidnih protivnetnih zdravil, vključno s selektivnimi zaviralci COX-2, z zaviralci ACE ali antagonisti angiotenzina II povzroči nadaljnje poslabšanje ledvične funkcije, vključno z akutno odpovedjo ledvic.
Inflammatory bowel disease.
Vnetna črevesna bolezen.
Following IV or IM injection, parecoxib is rapidly converted to valdecoxib, the pharmacologically active substance, by enzymatic hydrolysis in the liver.
Po intravenski ali intramuskularni injekciji se parekoksib z encimsko hidrolizo v jetrih hitro spremeni v farmakološko aktivno učinkovino valdekoksib.
Parecoxib is suspected to cause serious birth defects when administered during the last trimester of pregnancy because as with other medicinal products known to inhibit prostaglandin, it may cause premature closure of the ductus arteriosus or uterine inertia (see sections 4.3, 5.1 and 5.3).
Obstaja sum, da lahko parekoksib v zadnjem trimesečju nosečnosti povzroči resne okvare ploda, ker lahko - tako kot druga zdravila, ki zavirajo prostaglandine - povzroči prezgodnje zaprtje arterioznega duktusa ali inertnost maternice (glejte poglavja 4.3, 5.1 in 5.3).
There is limited experience in other types of surgery, for example gastrointestinal or urological surgery (see section 5.1).
Izkušnje pri drugih vrstah operacij, npr. gastrointestinalnih in uroloških, so omejene (glejte poglavje 5.1).
Gastrointestinal studies
Študije trombocitov
5 + 5 pack: contains 5 powder vials and 5 solvent ampoules.
Pakiranje 5 + 5: vsebuje 5 vial praška in 5 ampul vehikla.
There is no clinical experience in patients with severe hepatic impairment (Child-Pugh score 10), therefore its use is contraindicated in these patients (see sections 4.3 and 5.2).
Kliničnih izkušenj pri bolnikih s hudo okvaro jeter (ocena  10 po Child-Pughu) ni, zato je zdravilo pri njih kontraindicirano (glejte poglavji 4.3 in 5.2).
Plasma exposure of omeprazole (CYP 2C19 substrate) 40 mg once daily was increased by 46% following administration of valdecoxib 40 mg twice daily for 7 days, while the plasma exposure to valdecoxib was unaffected.
Plazemska izpostavljenost omeprazolu (substratu CYP2C19) v odmerku 40 mg enkrat na dan se je po 7-dnevni uporabi valdekoksiba 40 mg dvakrat na dan povečala za 46 %, plazemska izpostavljenost valdekoksibu pa se ob tem ni spremenila.
Average Cmax of parecoxib after IM dosing was lower compared to bolus IV dosing, which is attributed to slower extravascular absorption after IM administration.
Povprečna Cmax parekoksiba je bila po intramuskularni uporabi manjša kot po bolusni intravenski uporabi, kar je treba pripisati počasnejši zunajžilni absorpciji po intramuskularni aplikaciji.
Thus, 24 hours should be considered the maximum shelf life of the reconstituted product.
Torej je maksimalni rok uporabnosti rekonstituirane raztopine 24 ur.
Blood pressure should be monitored closely during the initiation of therapy with parecoxib and throughout the course of therapy.
Med uvedbo in ves čas zdravljenja s parekoksibom je treba natančno nadzirati krvni tlak.
Valdecoxib is eliminated via hepatic metabolism with less than 5% unchanged valdecoxib recovered in the urine.
Valdekoksib se izloča s presnovo v jetrih; manj kot 5 % valdekoksiba se nespremenjenega izloči z urinom.
In clinical trials, the daily requirement for PRN opioids was significantly reduced when coadministered with parecoxib.
V kliničnih preskušanjih se je dnevna potreba po opioidih PP (PP - po potrebi) pomembno zmanjšala, če so bili uporabljeni sočasno s parekoksibom.
Nine prespecified adverse event categories were evaluated (cardiovascular thromboembolic events, pericarditis, new onset or exacerbation of congestive heart failure, renal failure/dysfunction, upper GI ulcer complications, major non-GI bleeds, infections, non-infectious pulmonary complications, and death).
Ocenjevali so devet vnaprej določenih kategorij neželenih dogodkov (kardiovaskularni/trombembolični dogodki, perikarditis, ponovni pojav ali poslabšanje kongestivnega srčnega popuščanja, odpoved/poslabšano delovanje ledvic, zapleti z razjedami v zgornjih prebavilih, močne krvavitve, ki ne izvirajo iz prebavil, infekcije, neinfektivni pulmonalni zapleti in smrt).
As with other medicinal products known to inhibit prostaglandin synthesis, fluid retention and oedema have been observed in some patients taking parecoxib.
Tako kot pri drugih zdravilih, ki zavirajo sintezo prostaglandinov, so tudi pri bolnikih, ki so jemali parekoksib, opazili zastajanje tekočine in edeme.
The solvent is contained in colourless neutral glass ampoules (2 ml).
Vehikel je pakiran v brezbarvne ampule (2 ml) iz nevtralnega stekla.
Metabolism and nutrition disorders Hypokalaemia Hyperglycaemia, anorexia
Presnovne in prehranske motnje Hipokaliemija Hiperglikemija, anoreksija
Oral anticoagulants include warfarin/coumarin-type and novel oral anticoagulants (e.g. apixaban, dabigatran, and rivaroxaban) (see section 4.5).
Med peroralne antikoagulante uvrščamo peroralne antikoagulante varfarinskega/kumarinskega tipa in novejše peroralne antikoagulante (npr. apiksaban, dabigatran in rivaroksaban) (glejte poglavje 4.5).
3 + 3 pack: contains 3 powder vials and 3 solvent ampoules.
Pakiranje 3 + 3: vsebuje 3 viale praška in 3 ampule vehikla.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, and is therefore considered essentially ‘sodium- free'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni »brez natrija«.
In young subjects, Dynastat 40 mg twice daily had no clinically significant effect on acetylsalicylic acid-mediated inhibition of platelet function (see section 4.5).
Pri mladih preskušancih zdravilo Dynastat v odmerku 40 mg dvakrat na dan ni klinično pomembno vplivalo na zavrtje delovanja trombocitov z acetilsalicilno kislino (glejte poglavje 4.5).
In patients with moderate hepatic impairment (Child-Pugh score 7-9), treatment should be initiated with half the usual recommended dose of Dynastat and the maximum daily dose should be reduced to 40 mg since valdecoxib exposures were more than doubled (130%) in these patients.
Pri bolnikih z zmerno okvaro jeter (ocena od 7 do 9 po Child-Pughu) je treba zdravljenje začeti s polovičnim običajnim priporočenim odmerkom zdravila Dynastat, največji dnevni odmerek pa je treba zmanjšati na 40 mg, ker so pri teh bolnikih ugotovili več kot dvojno (130 %) izpostavljenost valdekoksibu.
Patients with severe hepatic impairment have not been studied and therefore the use of Dynastat in patients with severe hepatic impairment is not recommended (see sections 4.2 and 4.3).
Študij pri bolnikih s hudo okvaro jeter ni bilo, zato uporaba zdravila Dynastat zanje ni priporočljiva (glejte poglavji 4.2 in 4.3).
Since prostaglandin synthesis inhibition may result in deterioration of renal function and fluid retention, caution should be observed when administering Dynastat in patients with impaired renal function (see section 4.2) or hypertension, or in patients with compromised cardiac or hepatic function or other conditions predisposing to fluid retention.
Ker lahko zavrtje sinteze prostaglandinov poslabša delovanje ledvic in povzroči zastajanje tekočine, je treba zdravilo Dynastat uporabljati previdno pri bolnikih z oslabelim delovanjem ledvic (glejte poglavje 4.2) ali hipertenzijo ali oslabelim delovanjem srca, jeter ali drugimi stanji, ki povečujejo zastajanje tekočine.
Plasma exposure (AUC and Cmax) to valdecoxib was increased (38% and 24%, respectively) when coadministered with ketoconazole (CYP3A4 inhibitor), however, a dosage adjustment should not generally be necessary for patients receiving ketoconazole.
Plazemska izpostavljenost (AUC in Cmax) valdekoksibu se je med sočasno uporabo ketokonazola (zaviralca CYP3A4) povečala (AUC za 38 % in Cmax za 24 %), vendar bolnikom, ki prejemajo ketokonazol, odmerka praviloma ni treba prilagajati.
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.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti in toksičnosti pri ponavljajočih se odmerkih pri 2-kratni največji človeški izpostavljenosti parekoksibu ne kažejo posebnega tveganja za človeka.
Dynastat must not be administered to women who breast-feed (see section 4.3).
Zdravila Dynastat ne smemo dajati doječim ženskam (glejte poglavje 4.3).
The efficacy of Dynastat was established in studies of dental, gynaecologic (hysterectomy), orthopaedic (knee and hip replacement), and coronary artery bypass graft surgical pain.
Učinkovitost zdravila Dynastat so ugotovili v študijah operacijske bolečine pri stomatoloških, ginekoloških (histerektomija) in ortopedskih posegih (zamenjava kolka in kolena) ter obvodni operaciji koronarnih arterij.
In the submitted studies, as with other NSAIDs, an increased risk of gastrointestinal ulceration or other gastrointestinal complications compared to use of parecoxib alone was shown for concomitant administration of low-dose acetylsalicylic acid (see section 5.1).
V predloženih študijah so (tako kot velja za druga nesteroidna protivnetna zdravila) ugotovili večje tveganje za razjede in druge zaplete na prebavilih, če je bil parekoksib uporabljen z majhnim odmerkom acetilsalicilne kisline, kot če je bil uporabljen sam (glejte poglavje 5.1).
Administration of IV parecoxib 40 mg had no significant effect on the pharmacokinetics of either IV fentanyl or IV alfentanil (CYP3A4 substrates).
Uporaba intravenskega parekoksiba v odmerku 40 mg ni pomembno vplivala na farmakokinetiko intravenskega fentanila ali intravenskega alfentanila (substratov CYP3A4).
Rare: may affect up to 1 in 1,000 people ▪ Rash or ulceration in any part of your body (e.g. skin, mouth, eyes, face, lips or tongue), or any other signs of allergic reactions such as skin rash, swelling of the face, lips and tongue,
• izpuščaj ali razjeda na kateremkoli delu vašega telesa (npr. koža, usta, oči, obraz, ustnice ali jezik) ali kakršnikoli drugi znaki alergijske reakcije, na primer kožni izpuščaj, otekanje obraza,
Dynastat and opioids should not be administered together in the same syringe.
Zdravila Dynastat ne smemo aplicirati v isti brizgi skupaj z opioidi.
Do not take Dynastat: - if you are allergic to parecoxib or any of the other ingredients of this medicine (listed in section
• če ste alergični na parekoksib ali katerokoli sestavino tega zdravila (navedeno v poglavju 6)
Injectable anaesthetics
Inhalacijski anestetiki
They will dissolve the powder before giving you the injection, and will inject the solution into a vein or a muscle.
Raztopino vam bo injiciral/a v veno ali mišico.
Exposure of valdecoxib following single doses of Dynastat, as measured by both the area under the plasma concentration vs. time curve (AUC) and peak concentration (Cmax), is approximately linear in the range of clinical doses.
Izpostavljenost valdekoksibu, merjena s površino pod krivuljo koncentracije v plazmi v odvisnosti od časa (AUC) in največjo koncentracijo v plazmi (Cmax), je po enkratnih odmerkih zdravila Dynastat v območju kliničnih odmerkov približno linearna.
Therefore, parecoxib should be used with caution in patients with compromised cardiac function, preexisting oedema, or other conditions predisposing to, or worsened by, fluid retention including those taking diuretic treatment or otherwise at risk of hypovolemia.
Zato je treba parekoksib uporabljati previdno pri bolnikih z okvarjenim delovanjem srca, obstoječim edemom ali drugimi boleznimi, ki povzročijo nagnjenost k zastajanju tekočine, ali ki se poslabšajo z zastajanjem tekočine, vključno z bolniki, ki dobivajo diuretike ali jih sicer ogroža hipovolemija.
Coadministration of valdecoxib with glibenclamide (CYP3A4 substrate) did not affect either the pharmacokinetics (exposure) or the pharmacodynamics (blood glucose and insulin levels) of glibenclamide.
Sočasna uporaba valdekoksiba in glibenklamida (substrata CYP3A4) ni vplivala niti na farmakokinetiko (izpostavljenost) niti na farmakodinamiko (koncentracijo glukoze in insulina v krvi) glibenklamida.
Coadministration of IV parecoxib 40 mg with propofol (CYP2C9 substrate) or midazolam (CYP3A4 substrate) did not affect either the pharmacokinetics (metabolism and exposure) or the pharmacodynamics (EEG effects, psychomotor tests and waking from sedation) of IV propofol or IV midazolam.
Sočasna uporaba intravenskega parekoksiba v odmerku 40 mg in propofola (substrata CYP2C9) ali midazolama (substrata CYP3A4) ni vplivala niti na farmakokinetiko (presnovo in izpostavljenost) niti na farmakodinamiko (EEG učinke, psihomotorične teste in prebujanje iz sedacije) intravenskega propofola ali intravenskega midazolama.
The reduction in opioid use with Dynastat treatment on Days 2 and 3 was 7.2 mg and 2.8 mg (37% and 28% respectively).This reduction in opioid use was accompanied by significant reductions in patient-reported opioid symptom distress.
Med zdravljenjem z zdravilom Dynastat se je uporaba opioidov 2. in 3. dan zmanjšala za 7,2 mg in 2,8 mg (tj. za 37 % oz. 28 %).
Valdecoxib is not removed by haemodialysis.
Hemodializa ne odstrani valdekoksiba.
After reconstitution, the liquid should be a clear solution.
Po rekonstituciji mora biti tekočina bistra raztopina.
1 + 1 pack: contains 1 powder vial and 1 solvent ampoule.
Pakiranje 1 + 1: vsebuje 1 vialo praška in 1 ampulo vehikla.
In post-marketing experience, toxic epidermal necrolysis has been reported in association with the use of valdecoxib, and cannot be ruled out for parecoxib (see section 4.4).
Med izkušnjami v obdobju trženja je bila toksična epidermalna nekroliza opisana v zvezi z uporabo valdekoksiba in je ni mogoče izključiti tudi pri parekoksibu (glejte poglavje 4.4).
The IV bolus injection may be given rapidly and directly into a vein or into an existing IV line.
bolusno injekcijo pa se lahko daje hitro in neposredno v veno ali v obstoječo intravensko pot.
Exposure to valdecoxib was similar in terms of AUC and Cmax following IV and IM administration.
Izpostavljenost valdekoksibu je bila glede na AUC in Cmax po intravenski in intramuskularni uporabi podobna.
Inhibition of prostaglandins by NSAIDs, including COX-2 inhibitors, may diminish the effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin II antagonists, beta-blockers and diuretics.
Zaviralni učinek nesteroidnih protivnetnih zdravil, vključno z zaviralci COX-2, na prostaglandine lahko zmanjša učinek zaviralcev angiotenzinske konvertaze (ACE - angiotensin converting enzyme), antagonistov angiotenzina II, antagonistov adrenergičnih receptorjev beta in diuretikov.
▪ If you have previously had an ulcer, bleeding or perforation of the gastrointestinal tract.
• če ste kdaj prej imeli razjedo, krvavitev ali predrtje (perforacijo) v prebavilih
What Dynastat looks like and contents of the pack Dynastat is available as a white to off-white powder.
Zdravilo Dynastat je na voljo v obliki belega do belkastega praška.
Plasma exposure (AUC and Cmax) to valdecoxib was increased (62% and 19%, respectively) when coadministered with fluconazole (predominantly a CYP2C9 inhibitor), indicating that the dose of parecoxib should be reduced in those patients who are receiving fluconazole therapy.
Plazemska izpostavljenost (AUC in Cmax) valdekoksibu se je med sočasno uporabo flukonazola (ki zavira predvsem CYP2C9) povečala (AUC za 62 % in Cmax za 19 %); kar kaže, da je treba pri bolnikih, ki dobivajo flukonazol, odmerek parekoksiba zmanjšati.
The powder is contained in colourless glass vials (5 ml) with a stopper, sealed with a purple flip-off cap on the aluminium overseal.
Prašek je pakiran v brezbarvne steklene viale (5 ml) z zamaškom, zaščitenim s prevleko iz aluminija, ki ima na sredini vijolično pretržno zaporko, ki se odstrani na poteg.
Reconstitution process
Postopek rekonstitucije
Dynastat is preservative free.
Zdravilo Dynastat ne vsebuje konzervansov.
Vascular disorders Hypertension, hypotension
Hipertenzija, hipotenzija
In a placebo-controlled, orthopedic and general surgery study (n =1050), patients received Dynastat at an initial parenteral dose of 40 mg IV followed by 20 mg twice daily for a minimum of 72 hours in addition to receiving standard care including supplemental patient controlled opioids.
V študiji na področju ortopedije in splošne kirurgije (n = 1050), ki je bila nadzorovana s placebom, so bolniki prejeli zdravilo Dynastat v začetnem parenteralnem odmerku 40 mg i.v., kateremu je sledil odmerek 20 mg dvakrat na dan, najmanj 72 ur.
The first CABG surgery study evaluated patients treated with IV parecoxib 40 mg bid for a minimum of 3 days, followed by treatment with valdecoxib 40 mg bid (parecoxib/valdecoxib group) (n=311) or placebo/placebo (n=151) in a 14-day, double-blind placebo-controlled study.
parekoksibom 40 mg dvakrat na dan najmanj 3 dni, čemur je sledilo zdravljenje z valdekoksibom 40 mg dvakrat na dan (skupina parekoksib/valdekoksib) (n = 311), ali prejemanje placeba/placeba (n = 151) v 14-dnevni dvojno slepi s placebom nadzorovani študiji.
There were no significant differences between active treatments and placebo for any of the other pre-specified event categories (renal dysfunction/failure, upper GI ulcer complications or surgical wound complications).
Aktivno zdravljenje se ni pomembno razlikovalo od placeba glede nobene vnaprej opredeljene kategorije pojavov (moteno delovanje ledvic/ledvična odpoved, zapleti z razjedami v zgornjih prebavilih ali zapleti kirurške rane).
Psychiatric disorders Agitation, insomnia Nervous system disorders Hypoaesthesia, dizziness
Psihiatrične motnje Agitiranost, nespečnost Bolezni živčevja Hipestezija, omotica
Following single IV and IM doses of parecoxib 20 mg, Cmax of valdecoxib is achieved in approximately 30 minutes and approximately 1 hour, respectively.
odmerkih 20 mg parekoksiba je Cmax valdekoksiba dosežena v približno 30 minutah (i.v.)
On the basis of pharmacokinetics, no dose adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance of 30-80 ml/min.
Glede na farmakokinetiko, bolnikom z blago do zmerno okvaro ledvic (očistek kreatinina 30-80 ml/min), odmerka ni treba prilagoditi.
OUTER CARTON: 40 mg vials
ZUNANJA ŠKATLA: 40 mg viale
Sodium chloride 9 mg/ml (0.9%) solution
Raztopina natrijevega klorida 9 mg/ml (0,9 %)
Patients should be adequately hydrated and the need to monitor the renal function should be assessed at the beginning of the concomitant treatment and periodically thereafter.
Na začetku sočasnega zdravljenja in občasno tudi kasneje je treba oceniti potrebo po spremljanju ledvične funkcije.
40 mg vial: Remove the purple flip-off cap to expose the central portion of the rubber stopper of the parecoxib 40 mg vial.
40-mg viala: Odstranite vijolično pretržno zaporko, da boste razkrili osrednji del gumijastega zamaška 40-mg viale parekoksiba.
Active peptic ulceration or gastrointestinal (GI) bleeding.
Aktivna peptična razjeda ali krvavitev v prebavilih.
Skin and subcutaneous tissue disorders Pruritus, hyperhidrosis
Bolezni kože in podkožja Srbenje, hiperhidroza
Dynastat has not been studied in cardiovascular revascularization procedures other than coronary artery bypass graft (CABG) procedures.
Zdravilo Dynastat, razen v študijo operacij obvodov koronarne arterije (CABG - coronary artery bypass graft), ni bilo vključeno v nobeno drugo študijo kardiovaskularnih kirurških postopkov revaskularizacije.
Patients without a history of sulfonamide allergy may also be at risk for serious skin reactions.
Tveganje za pojav resnih kožnih reakcij je lahko prisotno tudi pri bolnikih, ki nimajo alergije na sulfonamid v anamnezi.
In the second CABG surgery study, four pre-specified event categories were evaluated (cardiovascular/thromboembolic; renal dysfunction/renal failure; upper GI ulcer/bleeding; surgical wound complication).
V drugi študiji v zvezi z operativnim posegom CABG so ocenjevali štiri vnaprej določene kategorije dogodkov (kardiovaskularni/trombembolični, poslabšano delovanje/odpoved ledvic, razjeda v zgornjih prebavilih/krvavenje, zapleti v zvezi s kirurško rano).
When reconstituted in sodium chloride 9 mg/ml (0.9%) solution, Dynastat contains approximately 0.44 mEq of sodium per vial.
Po rekonstituciji z 9 mg/ml (0,9 %) raztopino natrijevega klorida zdravilo Dynastat vsebuje približno 0,44 mEq natrija na vialo.