natgillin/translations-raw huggingface dataset:
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 sodium.
Predstavlja približno 10% koncentracije valdekoksiba; zaradi majhne koncentracije tega presnovka ni pričakovati, da bi imel ob uporabi terapevtskih odmerkov natrijevega parekoksibata pomemben klinični učinek.
Elimination Valdecoxib is eliminated via hepatic metabolism with less than 5% unchanged valdecoxib recovered in the urine.
Izločanje Valdekoksib se izloča s presnovo v jetrih; manj kot 5% nespremenjenega valdekoksiba se izloči s sečem.
About 70% of the dose is excreted in the urine as inactive metabolites.
Približno 70% odmerka se izloči s sečem v obliki neaktivnih presnovkov.
Plasma clearance (CLp) for valdecoxib is about 6 l/ hr.
Plazemski očistek (OČp) valdekoksiba je okrog 6 l/ uro.
After IV or IM dosing of parecoxib sodium, the elimination half-life (t1/ 2) of valdecoxib is about 8 hours.
Po intravenskem ali intramuskularnem vnosu natrijevega parekoksibata je razpolovni čas izločanja (t1/ 2) valdekoksiba okrog 8 ur.
Elderly Subjects:
Starejše osebe:
Dynastat has been administered to 335 elderly patients (65-96 years of age) in pharmacokinetic and therapeutic trials.
Dynastat so v farmakokinetičnih in terapevtskih raziskavah dajali 335 starejšim bolnikom (starim od 65 do 96 let).
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.
Pri zdravih starejših preiskovancih je bil navidezni peroralni očistek valdekoksiba zmanjšan, kar je povzročilo približno 40% večjo plazemsko izpostavljenost valdekoksibu kot pri zdravih mladih preiskovancih.
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).
Po prilagoditvi za telesno težo je bila ravnotežna plazemska izpostavljenost valdekoksibu pri starejših ženskah 16% večja kot pri starejših moških (glejte poglavje 4. 2).
11 Renal Impairment:
Okvara ledvic:
In patients with varying degrees of renal impairment administered 20 mg IVDynastat, parecoxib was rapidly cleared from plasma.
Pri bolnikih z različno stopnjo okvare ledvic, ki so intravensko dobili 20 mg Dynastata, se je parekoksib hitro očistil iz plazme.
Because renal elimination of valdecoxib is not important to its disposition, no changes in valdecoxib clearance were found even in patients with severe renal impairment or in patients undergoing dialysis (see section 4.2).
11 njegovo odstranjevanje, sprememb očistka valdekoksiba niso ugotovili niti pri bolnikih s hudo ledvično okvaro ali na dializi (glejte poglavje 4. 2).
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 jetrno okvaro (ocena od 7 do 9 po Child- Pughu) je treba zdravljenje začeti s polovičnim običajnim priporočenim odmerkom Dynastata, 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).
Raziskav pri bolnikih s hudo jetrno okvaro ni bilo, zato uporaba Dynastata zanje ni priporočljiva (glejte poglavji 4. 2 in 4. 3).
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 temelju običajnih študij varnosti in toksičnosti pri ponavljajočih se odmerkih pri 2- kratni največji človeški izpostavljenosti parekoksibu niso pokazale posebne nevarnosti za človeka.
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.
Vendar je bila sistemska izpostavljenost valdekoksibu (aktivnemu presnovku parekoksiba) v raziskavah toksičnosti ponavljajočih se odmerkov pri psih in podganah približno 0, 8- kratnik sistemske izpostavljenosti pri starejših osebah ob največjem priporočenem terapevtskem odmerku 80 mg na dan.
Higher doses were associated with aggravation and delayed healing of skin infections, an effect probably associated with COX-2 inhibition.
Večji odmerki so bili povezani s poslabšanjem in upočasnjenim zdravljenjem kožnih okužb, kar je verjetno učinek, povezan z zavrtjem COX- 2.
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.
V preizkusih reprodukcijske toksičnosti se je incidenca poimplantacijskih izgub, resorpcij in upočasnitve telesne mase ploda pojavila v odmerkih, ki v raziskavah na kuncih niso povzročili maternalne toksičnosti.
The effects of parecoxib have not been evaluated in late pregnancy or in the pre- and postnatal period.
Učinkov parekoksiba niso ovrednotili v pozni nosečnosti in v pred - ali poporodnem obdobju.
Parecoxib sodium administered intravenously to lactating rats as a single dose showed concentrations of parecoxib, valdecoxib and a valdecoxib active metabolite in milk similar to that of maternal plasma.
Po aplikaciji enkratnega intravenskega odmerka natrijevega parekoksibata doječim podganam so se parekoksib, valdekoksib in aktivni presnovek valdekoksiba v mleku pojavili v podobni koncentraciji, kot v plazmi doječe podgane.
The carcinogenic potential of parecoxib sodium has not been evaluated.
Karcinogenega potenciala natrijevega parekoksibata niso ocenili.
Powder Disodium hydrogen phosphate Phosphoric acid and/ or sodium hydroxide (for pH adjustment).
Prašek natrijev hidrogenfosfat fosforjeva kislina in/ ali natrijev hidroksid (za uravnavanje pH)
This medicinal product must not be mixed with other medicinal products except for those mentioned in section 6.6.
Zdravila ni dovoljeno mešati z drugimi zdravili, razen s tistimi, ki so navedena v poglavju 6. 6.
Dynastat and opioids should not be administered together in the same syringe.
Dynastata ne smemo aplicirati v isti brizgi skupaj z opioidi.
Use of Ringer-Lactate solution for injection or glucose 50 g/ l (5%) in Ringer Lactate solution for injection for reconstitution will cause the parecoxib to precipitate from solution and therefore is not recommended.
Priprava raztopine natrijevega parekoksibata z uporabo raztopine Ringerjevega laktata za injiciranje ali 5% (50 g/ l) glukoze v raztopini Ringerjevega laktata za injiciranje povzroči precipitacijo parekoksiba iz raztopine in zato ni priporočljiva.
Use of Sterile Water for Injection is not recommended, as the resulting solution is not isotonic.
Uporaba vode za injekcije ni priporočljiva, ker nastala raztopina ni izotonična.
12 Do not inject Dynastat into an IV line delivering any other drug.
Zdravila Dynastat ne smemo aplicirati v intravensko pot, v katero apliciramo druga zdravila.
The IV line must be adequately flushed prior to and after Dynastat injection with a solution of known compatibility (see section 6.6).
Pred injiciranjem Dynastata in po njem je treba intravensko pot temeljito sprati s poznano kompatibilno raztopino.
Injection into an IV line delivering glucose 50 g/ l (5%) in Ringer-Lactate solution for injection, or other IV fluids not listed in 6.6, is not recommended as this may cause precipitation from solution.
12 Injiciranje v intravensko pot, po kateri teče 5% (50 g/ l) glukoza v raztopini Ringerjevega laktata ali kakšna druga intravenska tekočina, ki ni navedena v poglavju 6. 6, ni priporočljivo, ker lahko povzroči precipitacijo natrijevega parekoksiba iz raztopine.
Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 24 hours at 25°C.
Kemična in fizikalna stabilnost pripravljene raztopine sta dokazani za obdobje 24 ur pri temperaturi 25 °C.
From a microbiological point of view, the aseptically prepared product should be used immediately.
Z mikrobiološkega stališča je treba aseptično pripravljeno zdravilo uporabiti takoj.
If not used immediately, in-use 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, unless reconstitution has taken place in controlled and validated aseptic conditions.
Če pripravljene raztopine ne uporabite takoj, so čas shranjevanja pripravljene raztopine in pogoji pred uporabo odgovornost uporabnika; v povprečju naj čas ne bi bil daljši od 12 ur pri temperaturi 25°C, razen če je priprava raztopine potekala v nadzorovanih in preverjenih aseptičnih pogojih.
This medicinal product does not require special storing conditions prior to reconstitution.
Za shranjevanje zdravila pred pripravo niso potrebna posebna navodila.
Do not refrigerate or freeze reconstituted solutions.
Pripravljene raztopine ne shranjujte v hladilniku in je ne zamrzujte.
For storage conditions of the recosntituted medicinal product see section 6.3.
Za pogoje shranjevanja pripravljene raztopine glejte poglavje 6. 3.
Parecoxib sodium vials 20 mg vials:
Viale z natrijevim parekoksibatom 20- mg viale:
Type I colourless glass vials (2 ml) with a laminated stopper, sealed with a yellow flip- off cap on the aluminium overseal.
2- ml steklene viale iz brezbarvnega stekla tipa I z laminiranim zamaškom, zaščitenim s prevleko iz aluminija, ki ima na sredini rumeno pretržno zaporko, ki se odstrani na poteg.
Dynastat is available in packs containing 10 vials.
Dynastat je na voljo v naslednjem pakiranju: škatla z 10 vialami.
Dynastat must be reconstituted before use.
Dynastat je treba pred uporabo pripraviti.
Dynastat is preservative free.
Dynastat ne vsebuje konzervansov.
Reconstitution solvents Acceptable solvents for reconstitution of Dynastat are:
Vehikli za pripravo Dovoljeni vehikli za pripravo raztopine Dynastata so:
sodium chloride 9 mg/ ml (0.9%) solution glucose 50 g/ l (5%) solution for infusion sodium chloride 4.5 mg/ ml (0.45%) and glucose 50 g/ l (5%) solution for injection
0, 9% (9 mg/ ml) raztopina natrijevega klorida 5% (50 g/ l) raztopina glukoze za infundiranje raztopina 0, 45% (4, 5 mg/ ml) natrijevega klorida in 5% (50 g/ l) glukoze za injiciranje.
Reconstitution process Use aseptic technique to reconstitute lyophilised parecoxib (as parecoxib sodium).
Postopek priprave Za pripravo liofiliziranega parekoksiba (v obliki natrijevega parekoksibata) uporabite aseptični postopek.
Remove the yellow flip-off cap to expose the central portion of the rubber stopper of the 20 mg parecoxib vial.
Odstranite rumeno pretržno zaporko, da boste razkrili osrednji del gumijastega zamaška viale z 20 mg parekoksiba.
Withdraw, with a sterile needle and syringe, 1 ml of an acceptable solvent and insert the needle through the central portion of the rubber stopper transferring the solvent into the 20 mg vial.
S sterilno iglo in brizgo izvlecite 1 ml dovoljenega vehikla; zabodite iglo skozi osrednji del gumijastega zamaška in prenesite vehikel v 20- mg vialo.
After reconstitution, Dynastat should be inspected visually for particulate matter and discoloration prior to administration.
Po pripravi je treba Dynastat pregledati in se tako prepričati, da ne vsebuje delcev in ni obarvan.
The solution should not be used if discolored or cloudy, or if particulate matter is observed.
Če je raztopina obarvana, motna ali so v njej delci, je ne smete uporabiti.
Dynastat should be administered within 24 hours of reconstitution (see section 6.3), or discarded.
Dynastat je treba aplicirati v 24 urah po pripravi (glejte poglavje 6. 3) ali pa ga zavreči.
IV line solution compatibility After reconstitution with acceptable solvents, Dynastat may only be injected IV or IM, or into IV lines delivering:
13 Kompatibilnost z raztopinami v intravenski liniji Po pripravi z dovoljenim vehiklom smemo Dynastat injicirati samo intravensko ali intramuskularno, ali v intravensko pot, po kateri teče:
sodium chloride 9 mg/ ml (0.9%) solution glucose 50 g/ l (5%) solution for infusion sodium chloride 4.5 mg/ ml (0.45%) and glucose 50 g/ l (5%) solution for injection Ringer-Lactate solution for injection
0, 9% (9 mg/ ml) raztopina natrijevega klorida 5% (50 g/ l) raztopina glukoze za infundiranje raztopina 0, 45% (4, 5 mg/ ml) natrijevega klorida in 5% (50 g/ l) glukoze za injiciranje raztopina Ringerjevega laktata za injiciranje.
Any unusedproduct or waste material should be disposed of in accordance with local requirements.
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
22 March 2002 Date of first renewal:
22. 3. 2002
Dynastat 20 mg powder and solvent for solution for injection
Dynastat 20 mg prašek in vehikel za raztopino za injiciranje
Powder and solvent for solution for injection White to off-white powder.
Bel ali belkast prašek.
Solvent: clear, colourless solution.
Vehikel: bistra, brezbarvna raztopina
15 IV line solution compatibility After reconstitution with acceptable solvents, Dynastat may only be injected IV or IM, or into IV lines delivering: sodium chloride 9 mg/ ml (0.9%) solution glucose 50 g/ l (5%) solution for infusion sodium chloride 4.5 mg/ ml (0.45%) and glucose 50 g/ l (5%) solution for injection Ringer-Lactate solution for injection
0, 9% (9 mg/ ml) raztopina natrijevega klorida 5% (50 g/ l) raztopina glukoze za infundiranje raztopina 0, 45% (4, 5 mg/ ml) natrijevega klorida in 5% (50 g/ l) glukoze za injiciranje raztopina Ringerjevega laktata za injiciranje
In patients with severe renal impairment (creatinine clearance < 30 ml/ min.) or patients who may be predisposed to fluid retention parecoxib should be initiated at the lowest recommended dose and the patient's kidney function closely monitored (see sections 4.4 and 5.2).
Bolnikom s hudo okvaro ledvic (očistek kreatinina < 30 ml/ min) ali bolnikom, nagnjenim k zastoju tekočine, je treba parekoksib uvesti v najmanjšem priporočenem odmerku, bolnikovo delovanje ledvic pa je treba natančno nadzirati (glejte poglavji 4. 4 in 5. 2).
16 Established ischaemic heart disease, peripheral arterial disease and/ or cerebrovascular disease.
16
Because of the possibility for increased adverse reactions at higher doses of parecoxib, other COX-2 inhibitors and NSAIDs, patients treated with parecoxib should be reviewed following dose increase and, in the absence of an increase in efficacy, other therapeutic options should be considered (see section 4.2).
Zaradi možnosti številnejših neželenih učinkov pri večjih odmerkih parekoksiba, drugih zaviralcev COX- 2 in nesteroidnih protivnetnih zdravil, je treba bolnike, ki dobivajo parekoksib, po zvečanju odmerka ponovno pregledati in v primeru, da se učinkovitost ne zveča, pretehtati druge terapevtske možnosti (glejte poglavje 4. 2).
Studies in other surgeries than CABG procedures included patients with ASA (American Society of Anaesthesiology) Physical Status Class I-III only.
Študije drugih operacijskih posegov, razen postopke CABG, so vključevale le bolnike s kliničnim statusom ASA (ASA - American Society od Anaesthesiology), razreda I- III.
17 Parecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
17 Parekoksib moramo ukiniti ob prvem pojavu kožnega izpuščaja, lezij na sluznicah ali kakršnegakoli drugega znaka preobčutljivosti.
Serious skin reactions are known to occur with NSAIDs including COX-2 selective inhibitors as well as other medications.
Znano je, da se med uporabo nesteroidnih protivnetnih zdravil, vključno s selektivnimi zaviralci COX- 2, in tudi drugih zdravil pojavljajo resne kožne reakcije.
However, the reported rate of serious skin events appears to be greater for valdecoxib (the active metabolite of parecoxib) as compared to other COX-2 selective inhibitors.
Toda, kot kaže, je opisani delež resnih kožnih reakcij večji pri valdekoksibu (aktivnem presnovku parekoksiba) kot pri drugih selektivnih zaviralcih COX- 2.
18 Co-administration of parecoxib sodium and heparin did not affect the pharmacodynamics of heparin (activated partial thromboplastin time) compared to heparin alone.
18 Sočasna uporaba natrijevega parekoksibata in heparina ni vplivala na farmakodinamiko heparina (aktivirani delni tromboplastinski čas) v primerjavi z dajanjem samega heparina.
NSAIDs may reduce the effect of diuretics and antihypertensive medicinal products.
Nesteroidna protivnetna zdravila lahko zmanjšajo učinek diuretikov in antihipertenzivnih zdravil.
19 Co-administration of valdecoxib with glibenclamide (CYP3A4 substrate) did not affect either the pharmacokinetics (exposure) or the pharmacodynamics (blood glucose and insulin levels) of glibenclamide.
19 Anestetiki za injiciranje:
Parecoxib sodium 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 synthesis, it may cause premature closure of the ductus arteriosus or uterine inertia (see sections 4.3, 5.1 and 5.3).
Dynastat je kontraindiciran v zadnjem trimesečju nosečnosti (glejte poglavje 4. 3).
The
Te raziskave so vključevale stomatološke, ginekološke in ortopedske operacije, obvod na koronarnih arterijah ter predoperacijsko uporabo pred stomatološkimi in ortopedskimi posegi.
20 discontinuation rate due to adverse events in these studies was 5.0% for patients receiving Dynastat and 4.3% for patients receiving placebo.
Delež prekinitev zaradi neželenih učinkov je bil v teh raziskavah 5, 0% pri bolnikih, ki so dobivali Dynastat, in 4, 3% pri tistih, ki so dobivali placebo.
[Very Common (≥ 1/ 10), Common (≥ 1/ 100, < 1/ 10) Uncommon (≥ 1/ 1000, < 1/ 100) Rare (≥ 1/ 10,000, < 1/ 1000) Very rare (< 1/ 10,000), not known (cannot be estimated from the available data)] Infections and infestations Uncommon: abnormal sternal serous wound drainage, wound infection.
[Zelo pogosto (≥ 1/ 10), pogosto (≥ 1/ 100, < 1/ 10), občasno (≥ 1/ 1. 000, < 1/ 100), redko (≥ 1/ 10. 000, < 1/ 1. 000), zelo redko (< 1/ 10. 000), ni znano (ni mogoče oceniti iz podatkov, ki so na voljo)]
21 Following coronary artery bypass graft surgery, patients administered Dynastat have a higher risk of adverse events, such as cardiovascular/ thromboembolic events, deep surgical infections and sternal wound healing complications.
Po obvodni operaciji koronarnih arterij bolnike, ki dobijo Dynastat, bolj ogrožajo neželeni učinki, npr. kardiovaskularni/ tromboembolični dogodki, globoke kirurške okužbe in zapleti na sternalni rani.
In post-marketing experience, the following reactions have been reported in association with the use of parecoxib:
V pomarketinških raziskavah so bile v zvezi z uporabo parekoksiba opisane naslednje reakcije:
Rare: acute renal failure, renal failure, myocardial infarction, congestive heart failure, abdominal pain, nausea, vomiting, dyspnoea, tachycardia and Stevens-Johnson syndrome.
21 Redko: akutna odpoved ledvic, odpoved ledvic, miokardni infarkt, kongestivno srčno popuščanje, abdominalna bolečina, navzea, bruhanje, dispneja, tahikardija in Stevens- Johnsonov sindrom.
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
V študiji na področju ortopedije in splošne kirurgije (n = 1050), ki je bila nadzorovana s placebom, so bolniki prejeli Dynastat v začetnem parenteralnem odmerku 40 mg i. v., kateremu je sledil odmerek 20 mg dvakrat na dan, najmanj 72 ur.
22 a minimum of 72 hours in addition to receiving standard care including supplemental patient controlled opioids.
Poleg tega so dobivali standardno oskrbo, vključno z dodatnimi opioidi, ki jih je uravnaval bolnik.
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.
Manjšo uporabo opioidov pa je po navedbi bolnikov spremljalo bistveno manj neprijetnosti zaradi opioidnih simptomov.
Additional studies in other surgical settings provided similar observations.
Pri uporabi
There are no data indicating less overall adverse events associated with the use of parecoxib compared to placebo when used in conjunction with opioids.
22 parekoksiba v primerjavi s placebom niso zasledili podatkov, ki bi ob sočasnem jemanju opioidov nakazovali povezavo z manjšo prisotnostjo celotnih neželenih učinkov.
In addition to routine adverse event reporting, pre-specified event categories, adjudicated by an independent expert committee, were examined in two placebo- controlled safety studies in which patients received parecoxib sodium for at least 3 days and then were transitioned to oral valdecoxib for a total duration of 10-14 days.
Bolniki so dobivali natrijev parekoksib vsaj 3 dni, potem pa so prešli na peroralni valdekoksib v skupnem trajanju od 10 do 14 dni.
In a large (N=1050) major orthopedic/ general surgery trial, patients received an initial dose of parecoxib 40 mg IV, then 20 mg IV Q12H for a minimum of 3 days followed by valdecoxib PO (20 mg Q12H) (n=525) for the remainder of a 10 day treatment period, or placebo IV
V veliki (n = 1050) pomembni raziskavi ortopedskih/ splošnih kirurških posegov so bolniki najmanj 3 dni prejemali začetni odmerek parekoksiba 40 mg IV, nato 20 mg IV Q12H, nato pa valdekoksib peroralno (20 mg Q12H) (n = 525) preostalih 10 dni obdobja zdravljenja ali pa so po prejemanju placeba IV prejemali placebo peroralno (n = 525).
23 followed by placebo PO (n=525).
23 Raziskave trombocitov:
In healthy elderly subjects, the apparent oral clearance of valdecoxib was reduced, resulting in an approximately 40% higher plasma exposure of valdecoxib
Pri zdravih starejših preiskovancih je bil navidezni peroralni očistek valdekoksiba zmanjšan, kar je povzročilo približno 40% večjo plazemsko izpostavljenost valdekoksibu kot pri zdravih mladih preiskovancih.
Because renal elimination of valdecoxib is not important to its disposition, no changes in valdecoxib clearance were found even in patients with severe renal impairment or in patients undergoing dialysis (see section 4.2).
24 njegovo odstranjevanje, sprememb očistka valdekoksiba niso ugotovili niti pri bolnikih s hudo ledvično okvaro ali na dializi (glejte poglavje 4. 2).
Solvent Sodium chloride Hydrochloric acid or sodium hydroxide (for pH adjustment) Water for injections.
Vehikel natrijev klorid klorvodikova kislina ali natrijev hidroksid (za uravnavanje pH) voda za injekcije
25 Dynastat and opioids should not be administered together in the same syringe.
Dynastata ne smemo aplicirati v isti brizgi skupaj z opioidi.
Use of Sterile Water for Injection is not recommended, as the resulting solution is not isotonic.
25 Uporaba vode za injekcije ni priporočljiva, ker nastala raztopina ni izotonična.
Do not inject Dynastat into an IV line delivering any other drug.
Zdravila Dynastat ne smemo aplicirati v intravensko pot, v katero apliciramo druga zdravila.
Injection into an IV line delivering glucose 50 g/ l (5%) in Ringer-Lactate solution for injection, or other IV fluids not listed in 6.6, is not recommended as this may cause precipitation from solution.
Injiciranje v intravensko pot, po kateri teče 5% (50 g/ l) glukoza v raztopini Ringerjevega laktata ali kakšna druga intravenska tekočina, ki ni navedena v poglavju 6. 6, ni priporočljivo, ker lahko povzroči precipitacijo natrijevega parekoksiba iz raztopine.
For storage conditions of the reconstituted medicinal product see section 6.3.
Za pogoje shranjevanja pripravljene raztopine glejte poglavje 6. 3.