natgillin/translations-raw huggingface dataset:
Pregnancy, breast-feeding and fertility ▪ If you are pregnant or trying to become pregnant, tell your doctor. 
• Če ste noseči ali poizkušate zanositi, to povejte zdravniku.
Adequate monitoring of methotrexate-related toxicity should be considered when coadministering parecoxib and methotrexate. 
Med sočasno uporabo parekoksiba in metotreksata je zato treba razmisliti o ustreznem spremljanju z metotreksatom povezanih toksičnih učinkov.
No effects of parecoxib on male or female fertilities were found in rats. 
Pri podganah niso ugotovili, da bi parekoksib vplival na plodnost samcev ali samic.
Powder for solution for injection 
prašek za raztopino za injiciranje
Additionally, fatal reports of toxic epidermal necrolysis have been reported through postmarketing surveillance in patients receiving valdecoxib (the active metabolite of parecoxib) and cannot be ruled out for parecoxib (see section 4.8). 
Dodatno so v študijah v obdobju trženja pri bolnikih, ki so prejemali valdekoksib (aktivni presnovek parekoksiba), poročali o toksični epidermalni nekrolizi s smrtnim izidom; pojava le-teh ni mogoče izključiti pri uporabi parekoksiba (glejte poglavje 4.8).
Type I colourless glass vials (5 ml) with a butyl rubber stopper, sealed with a purple polypropylene flip-off cap on the aluminium overseal. 
5 ml steklene viale iz brezbarvnega stekla tipa I z zamaškom iz butilne gume, zaščitenim s prevleko iz aluminija, ki ima na sredini vijolično polipropilensko pretržno zaporko, ki se odstrani na poteg.
There were no significant differences in the overall safety profile, including the four pre-specified event categories described above for the second CABG surgery study, for parecoxib/valdecoxib compared to placebo treatment in these post-surgical patients. 
Pri bolnikih po prestani operaciji pri prejemanju parekoksiba/valdekoksiba v primerjavi s prejemanjem placeba niso zaznali nobenih pomembnih razlik v splošnem varnostnem profilu, vključno s predhodno določenimi štirimi kategorijami v zvezi z drugo študijo operacije CABG, ki so opisane zgoraj.
Exposure to parecoxib was similar after IV or IM administration in terms of AUC. 
Izpostavljenost parekoksibu je bila glede na AUC po intravenski in intramuskularni uporabi podobna.
Fluid retention, oedema, renal 
Zastajanje tekočine, edemi, ledvica
Valdecoxib is a selective COX-2 inhibitor within the clinical dose range. 
Valdekoksib v območju kliničnih odmerkov selektivno zavira COX-2.
Hydrochloric acid or sodium hydroxide (for pH adjustment) Water for injection. 
Vehikel natrijev klorid klorovodikova kislina ali natrijev hidroksid (za uravnavanje pH) voda za injekcije
3 vials and 3 solvent ampoules 
3 viale s praškom in 3 ampule z vehiklom
Each 2 ml of reconstituted powder contains 40 mg of parecoxib. 
2 ml rekonstituiranega praška vsebuje 40 mg parekoksiba.
The recommended dose is 40 mg administered intravenously (IV) or intramuscularly (IM), followed every 6 to 12 hours by 20 mg or 40 mg as required, not to exceed 80 mg/day. 
), ter nato vsakih 6 do 12 ur 20 mg ali 40 mg, glede na potrebo, vendar ne več kot 80 mg/dan.
After reconstitution, the concentration of parecoxib is 20 mg/ml. 
Koncentracija parekoksiba po rekonstituciji je 20 mg/ml.
Use of Ringer-Lactate solution for injection or glucose 50 mg/ml (5%) in Ringer Lactate solution for injection for reconstitution will cause the parecoxib to precipitate from solution and therefore is not recommended. 
Rekonstitucija raztopine natrijevega parekoksibata z uporabo raztopine Ringerjevega laktata za injiciranje ali 50 mg/ml (5 %) glukoze v raztopini Ringerjevega laktata za injiciranje povzroči precipitacijo parekoksiba iz raztopine in zato ni priporočljiva.
- If you get any side effects, talk to your doctor or nurse. 
- Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom ali medicinsko sestro.
Hypersensitivity reactions (anaphylaxis and angioedema) have been reported in post-marketing experience with valdecoxib and parecoxib (see section 4.8). 
Med izkušnjami z valdekoksibom in parekoksibom so v obdobju trženja poročali o preobčutljivostnih reakcijah (anafilaksa in angioedem) (glejte poglavje 4.8).
If any of these applies to you, you will not be given the injection. 
Če karkoli od naštetega velja za vas, injekcije ne boste dobili, zato morate o tem nemudoma obvestiti zdravnika ali medicinsko sestro.
Serious skin reactions, including erythema multiforme, exfoliative dermatitis and Stevens-Johnson syndrome (some of them fatal) have been reported through post-marketing surveillance in patients receiving parecoxib. 
V študijah v obdobju trženja so pri bolnikih, ki so prejemali parekoksib, poročali o hudih kožnih reakcijah, vključno z multiformnim eritemom, eksfoliativnim dermatitisom in Stevens-Johnsonovim sindromom (nekateri s smrtnim izidom).
As the cardiovascular risk of cyclooxygenase-2 (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 ciklooksigenaze-2 (COX-2) se lahko poveča s povečevanjem odmerka in s trajanjem izpostavljenosti zdravilu.
Pancreatitis, oesophagitis, oedema mouth (perioral swelling) 
Pankreatitis, ezofagitis, edem ust (perioralna oteklina)
Acute renal failure has been reported through post-marketing surveillance in patients receiving parecoxib (see section 4.8). 
Med študijami v obdobju trženja so pri bolnikih, ki so prejemali parekoksib, poročali o akutni odpovedi ledvic (glejte poglavje 4.8).
Opioid-sparing effects 
Učinek manjše uporabe opioidov
Of the patients treated with placebo, 270 patients received placebo for up to 4 days, 43 patients for up to 5 days, while only 3 patients were treated for up to 6 days and 2 patients for 7 or more days. 
43 bolnikov do 5 dni, le 3 bolnike pa so zdravili do 6 dni in 2 bolnika 7 dni ali več.
Dynastat contains the active substance parecoxib. 
Zdravilo Dynastat vsebuje učinkovino parekoksib.
It is not recommended to inject into an IV line delivering glucose 50 mg/ml (5%) in RingerLactate solution for injection, or other IV fluids not listed in this section, as this may cause precipitation from solution. 
Ni priporočljivo, da bi zdravilo injicirali v intravensko pot, po kateri teče 50 mg/ml (5 %) glukoza v raztopini Ringerjevega laktata za injiciranje ali kakršnakoli druga intravenska tekočina, ki ni navedena v tem poglavju, ker to lahko povzroči precipitacijo iz raztopine.
There was a significantly (p<0.05) greater incidence of cardiovascular/thromboembolic events (myocardial infarction, ischemia, cerebrovascular accident, deep vein thrombosis and pulmonary embolism) detected in the parecoxib/valdecoxib treatment group compared to the placebo/placebo treatment group for the IV dosing period (2.2% and 0.0% respectively) and over the entire study period (4.8% and 1.3% respectively). 
Pomembno večjo pojavnost (p < 0,05) kardiovaskularnih/trombemboličnih dogodkov (miokardni infarkt, ishemijo, cerebrovaskularni insult, globoko vensko trombozo in pljučno embolijo) so odkrili pri skupini, zdravljeni s parekoksibom/valdekoksibom, v primerjavi s skupino, ki je v obdobju i.v.
This medicinal product contains less than 23 mg of sodium in each dose and therefore is essentially sodium-free. 
Zdravilo Dynastat vsebuje natrij To zdravilo vsebuje manj kot 23 mg natrija na odmerek, kar v bistvu pomeni 'brez natrija'.
IV line solution compatibility 
Kompatibilnost v intravenski poti
The only other acceptable solvents for reconstitution are: 
Kot drugi vehikel za pripravo raztopine so dovoljeni samo:
or muscle tissue. 
• obarvanje kože ali modrice
Renal failure acute 
Akutna ledvična odpoved
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 for at least 3 days and then were transitioned to oral valdecoxib for a total duration of 10-14 days. 
Poleg rutinskega poročanja neželenih dogodkov so v dveh s placebom nadzorovanih študijah varnosti raziskali vnaprej opredeljene kategorije pojavov, ki jih je presojal odbor neodvisnih strokovnjakov.
If you get any side effects, talk to your doctor or nurse. 
Če opazite kateregakoli izmed neželenih učinkov, se posvetujte z zdravnikom ali medicinsko sestro.
BUN increased. 
• povečano znojenje
Powder vial: Each vial contains 40 mg parecoxib (as 42.36 mg parecoxib sodium). 
Viala s praškom: Ena viala vsebuje 40 mg parekoksiba (v obliki 42,36 mg natrijevega parekoksibata).
Upper gastrointestinal (GI) complications (perforations, ulcers or bleedings [PUBs]), some of them resulting in fatal outcome, have occurred in patients treated with parecoxib. 
Pri bolnikih, zdravljenih s parekoksibom, so se pojavili zapleti v zgornjih prebavilih (perforacije, ulkusi ali krvavitve), ki so imeli v nekaterih primerih smrten izid.
Disodium hydrogen phosphate Phosphoric acid and/or sodium hydroxide (for pH adjustment). 
Prašek natrijev hidrogenfosfat fosforjeva kislina in/ali natrijev hidroksid (za uravnavanje pH).
How to store Dynastat 
Shranjevanje zdravila Dynastat
- if you have had a serious allergic reaction (especially a serious skin reaction) to any medicines - if you have had an allergic reaction to a group of medicines called “sulfonamides” (e.g. some antibiotics used to treat infections) - if you currently have a gastric or intestinal ulcer or bleeding in the stomach or gut - if you have had an allergic reaction to acetylsalicylic acid (aspirin) or to other NSAIDs (e.g. 
• če ste imeli alergijsko reakcijo na skupino zdravil, imenovano “sulfonamidi” (npr. nekateri antibiotiki za zdravljenje okužb)
Caution should be used when initiating treatment with Dynastat in patients with dehydration. 
Pri dehidriranih bolnikih je med uvajanjem zdravljenja z zdravilom Dynastat potrebna previdnost.
Injection into an IV line delivering glucose 50 mg/ml (5%) in Ringer-Lactate solution for injection, or other IV fluids not listed in section 6.6, is not recommended as this may cause precipitation from solution. 
Injiciranje v intravensko pot, po kateri teče 50 mg/ml (5 %) 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.
Abnormal sternal serous wound drainage, wound infection Blood and lymphatic system disorders Anaemia postoperative 
Bolezni krvi in limfatičnega sistema Pooperacijska anemija
Withdraw with a sterile needle and syringe, 2 ml of an acceptable solvent and insert the needle through the central portion of the rubber stopper transferring the solvent into the parecoxib 40 mg vial. 
S sterilno iglo in brizgo izvlecite 2 ml dovoljenega vehikla; zabodite iglo skozi osrednji del gumijastega zamaška in prenesite vehikel v 40 mg vialo.
Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or nonsteroidal antiinflammatory drugs (NSAIDs) including COX-2 inhibitors. 
Bolniki, ki so po uporabi acetilsalicilne kisline ali nesteroidnih protivnetnih zdravil (NSAIDnonsteroidal anti-inflammatory drugs), vključno z zaviralci COX-2, doživeli bronhospazem, akutni rinitis, nosne polipe, angionevrotičen edem, urtikarijo ali druge alergijske reakcije.
Each vial contains 40 mg parecoxib, as 42.36 mg parecoxib sodium. 
Ena viala vsebuje 40 mg parekoksiba, kar ustreza 42,36 mg natrijevega parekoksibata.
Caution should be exercised with respect to monitoring the incision for signs of infection in surgical patients receiving Dynastat. 
Kirurškim bolnikom, zdravljenim z zdravilom Dynastat, je treba iz previdnosti nadzirati operacijsko rano glede prisotnosti znakov okužbe.
Thus, each 2 ml of reconstituted solution contains 40 mg of parecoxib. 
Tako 2 ml rekonstituirane raztopine vsebuje 40 mg parekoksiba.
Dynastat should be introduced with caution and at half the usual recommended dose in patients with moderate hepatic impairment (Child-Pugh score 7-9) and the maximum daily dose should be reduced to 40 mg. 
Pri bolnikih z zmerno okvaro jeter (ocena od 7 do 9 po Child-Pughu) pa je treba zdravljenje začeti previdno in s polovičnim običajnim priporočenim odmerkom zdravila Dynastat; maksimalni dnevni odmerek je treba zmanjšati na 40 mg.
Administration is by intramuscular (IM) or intravenous (IV) injection. 
Zdravilo se aplicira kot intramuskularna (i.m.)
The magnitude of analgesic effect of the 40 mg dose was comparable with that of ketorolac 60 mg IM or ketorolac 30 mg IV. After a single dose, the duration of analgesia was dose and clinical pain model dependent, and ranged from 6 to greater than 12 hours. 
Izrazitost analgetičnega učinka 40 mg odmerka je bila primerljiva tisti po 60 mg ketorolaka intramuskularno ali 30 mg ketorolaka intravensko.
• sodium chloride 9 mg/ml (0.9%) solution for injection/infusion 
• 9 mg/ml (0,9 %) raztopina natrijevega klorida za injiciranje/infundiranje
Cardiovascular 
Trombocitopenija
Renal function should be monitored when parecoxib and any of these medicinal products are coadministered. 
Med sočasno uporabo parekoksiba s katerim od teh zdravil je treba nadzirati delovanje ledvic.
Each vial contains 40 mg parecoxib (as 42.36 mg parecoxib sodium). 
Ena viala vsebuje 40 mg parekoksiba (v obliki 42,36 mg natrijevega parekoksibata).
Use aseptic technique to reconstitute lyophilised parecoxib (as parecoxib). 
Za rekonstitucijo liofiliziranega parekoksiba (v obliki parekoksiba) uporabite aseptično tehniko.
Patients were randomized within 24-hours post-CABG surgery to: parecoxib initial dose of 40 mg IV, then 20 mg IV Q12H for a minimum of 3 days followed by valdecoxib PO (20 mg Q12H) (n=544) for the remainder of a 10 day treatment period; placebo IV followed by valdecoxib PO (n=544); or placebo IV followed by placebo PO (n=548). 
na 12 ur najmanj 3 dni, nato pa preostalih 10 dni zdravljenja še valdekoksib peroralno (20 mg na 12 ur) (n = 544); po prejemanju placeba i.v.
The IM injection is to be given slowly and deeply into the muscle and the IV bolus injection may be given rapidly and directly into a vein or into an existing IV line. 
Intravensko bolusno injekcijo se lahko daje hitro in neposredno v veno ali v obstoječo intravensko pot.
• sodium chloride 9 mg/ml (0.9%) solution for injection/infusion; 
• 9 mg/ml (0,9 %) raztopina natrijevega klorida za injiciranje/infundiranje;
Lithium serum concentration should be monitored closely when initiating or changing parecoxib therapy in patients receiving lithium. 
Če uvedemo ali spremenimo zdravljenje s parekoksibom pri bolnikih, ki dobivajo litij, je treba koncentracijo litija v serumu natančno nadzorovati.
Reconstitution solvents Reconstitute Dynastat 40 mg with 2 ml sodium chloride 9 mg/ml (0.9%) solution. 
Vehikli za rekonstitucijo Za pripravo raztopine 40 mg zdravila Dynastat uporabite 2 ml raztopine natrijevega klorida 9 mg/ml
Injection into an IV line delivering glucose 50 mg/ml (5%) in Ringer-Lactate solution for injection, or other IV fluids not listed above, is not recommended as this may cause precipitation from solution. 
Injiciranje v intravensko pot, po kateri teče 50 mg/ml (5 %) glukoza v raztopini Ringerjevega laktata za injiciranje ali kakšna druga intravenska tekočina, ki ni navedena v tem poglavju, ni priporočljivo, ker lahko povzroči precipitacijo iz raztopine.
Acetylsalicyclic acid and other NSAIDs 
• acetilsalicilno kislino (aspirin) ali druga protivnetna zdravila
Reactions might include wheezing (bronchospasm), badly blocked nose, itchy skin, rash or swelling of the face, lips or tongue, other allergic reactions or nasal polyps after taking these medicines - if you are more than 6 months pregnant - if you are breast-feeding - if you have severe liver disease - if you have inflammation of the intestines (ulcerative colitis or Crohn's disease) - if you have heart failure - if you are about to have heart surgery or surgery on your arteries (including any coronary artery procedure) 
Taka reakcija lahko vključuje piskajoče dihanje (bronhospazem), zelo zamašen nos, srbenje kože, izpuščaj ali otekanje obraza, ustnic ali jezika, druge alergijske reakcije ali nosne polipe po jemanju teh zdravil
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING 
Izgled zdravila Dynastat in vsebina pakiranja
Ecchymosis, rash, urticaria 
Ekhimoze, izpuščaj, urtikarija
▪ Dry socket (inflammation and pain after a tooth extraction) ▪ Increased sweating ▪ Low levels of potassium in blood test results 
• sindrom suhe jamice (vnetje in bolečina po izdrtju zoba)
Some people may be given lower doses: ▪ People with liver problems ▪ People with severe kidney problems ▪ Patients over 65 who weigh less than 50 kg ▪ People taking fluconazole. 
• bolniki, starejši od 65 let, ki tehtajo manj kot 50 kg
- if you have established heart disease and /or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages - if you have or have had problems with your blood circulation (peripheral arterial disease) 
možgansko kap, lažjo obliko možganske kapi (tranzitorna ishemična ataka - TIA), ali zamašitev krvnih žil, ki vodijo do srca ali možganov, ali operativno odstranitev ali obvod zamašenega dela
Surgical wound complications (most involving the sternal wound) were observed at an increased rate with parecoxib/valdecoxib treatment. 
Pri zdravljenju s parekoksibom/valdekoksibom so opazili več zapletov v zvezi s kirurškimi ranami (največkrat v zvezi z rano prsnice).
It is one of a family of medicines called COX-2 inhibitors (this is short for cyclo-oxygenase-2 inhibitors). 
Gre za zdravilo iz skupine t. i. zaviralcev COX-2 (to je okrajšava za "zaviralci ciklooksigenaze-2").Bolečino in otekanje v telesu včasih povzročijo posebne snovi, ki se imenujejo prostaglandini.
OUTER CARTON: 40 mg powder and solvent for solution for injection 
ZUNANJA ŠKATLA: 40 mg prašek in vehikel za raztopino za injiciranje
Cases of severe hypotension shortly following parecoxib administration have been reported in postmarketing experience with parecoxib. 
V obdobju po začetku trženja zdravila so poročali o primerih hude hipotenzije, ki se je pojavila kmalu po aplikaciji parekoksiba.
▪ Acetylsalicylic acid (aspirin) or other anti-inflammatory medicines ▪ Fluconazole - used for fungal infections ▪ ACE inhibitors, Angiotensin-II inhibitors, beta blockers and diuretics - used for high blood pressure and heart conditions ▪ Ciclosporin or Tacrolimus - used after transplants ▪ Warfarin - or other warfarin like medicines used to prevent blood clots including newer medicines like apixaban, dabigatran, and rivaroxaban 
• zaviralce ACE, antagoniste angiotenzina II, antagoniste adrenergičnih receptorjev beta in diuretike - uporabljajo se pri visokem krvnem tlaku in boleznih srca
• glucose 50 mg/ml (5%) solution for infusion 
• 50 mg/ml (5 %) raztopina glukoze za infundiranje
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 followed by placebo PO (n=525). 
na 12 ur, nato pa valdekoksib peroralno (20 mg na 12 ur) (n = 525) preostalih 10 dni obdobja zdravljenja ali pa so po prejemanju placeba i.v.
• glucose 50 mg/ml (5%) solution for infusion; 
• 50 mg/ml (5%) raztopina glukoze za infundiranje;
Dynastat 40 mg powder for solution for injection 
Dynastat 40 mg prašek za raztopino za injiciranje
Administration other than IV or IM 
NAVEDBA ENE ALI VEČ UČINKOVIN
▪ Lithium - used to treat depression ▪ Rifampicin - used for bacterial infections ▪ Antiarrhythmics - used to treat an irregular heartbeat ▪ Phenytoin or Carbamazepine - used for epilepsy ▪ Methotrexate - used for rheumatoid arthritis and cancer ▪ Diazepam - used for sedation and anxiety ▪ Omeprazole - used for treating ulcers 
• diazepam - uporablja se za pomiritev in pri tesnobi • omeprazol - uporablja se za zdravljenje razjed
Dosing. 
Dojenje
Dynastat 40 mg powder for injection Parecoxib 
Dynastat 40 mg prašek za raztopino za injiciranje parekoksib
Dynastat should be inspected visually for particulate matter and discoloration prior to administration. 
Zdravilo Dynastat je treba pregledati in se tako prepričati, da ne vsebuje delcev in ni obarvan.
No dosage adjustment is generally necessary in patients with mild hepatic impairment (Child-Pugh score 5-6). 
Bolnikom z blago okvaro jeter (ocena od 5 do 6 po Child-Pughu) odmerka praviloma ni treba prilagajati.
▪ If you are dehydrated - this may happen if you have had diarrhoea or have been vomiting (being sick) or unable to drink fluids ▪ If you have an infection as it may hide a fever (which is a sign of infection) ▪ If you use medicines to reduce blood clotting (e.g. warfarin/warfarin like anticoagulants or novel oral anti-clotting medicines, e.g. apixaban, dabigatran, and rivaroxaban) ▪ If you use medicines called corticosteroids (e.g. prednisone) ▪ If you use a class of medicines used to treat depression called selective serotonin re-uptake inhibitors (e.g. sertraline) 
• če jemljete zdravila proti strjevanju krvi (npr. varfarin/varfarinu podobne antikoagulante ali novejše peroralne antikoagulante, npr. apiksaban, dabigatran in rivaroksaban)
• sodium chloride 4.5 mg/ml (0.45%) and glucose 50 mg/ml (5%) solution for injection/infusion. 
• 4,5 mg/ml (0,45 %) raztopina natrijevega klorida in 50 mg/ml (5 %) raztopina glukoze za injiciranje/infundiranje.
• sodium chloride 4.5 mg/ml (0.45%) and glucose 50 mg/ml (5%) solution for injection/infusion; or 
• 4,5 mg/ml (0,45 %) raztopina natrijevega klorida in 50 mg/ml (5 %) raztopina glukoze za injiciranje/infundiranje; ali
• glucose 50 mg/ml (5%) solution for infusion; or 
• 5 % (50 mg/ml) raztopino glukoze za infundiranje; ali
Uncommon: may affect up to 1 in 100 people ▪ Heart attack ▪ There is a risk of cerebrovascular disease e.g. stroke, or transient ischaemic attack (transient reduced blood flow to the brain)/mini-stroke or angina, or blockages to blood vessels to the heart or brain ▪ Blood clot in the lungs ▪ Worsening of high blood pressure ▪ Ulcers in the digestive system, chronic stomach acid reflux ▪ The heart may beat more slowly 
(prehodno zmanjšan pretok krvi v možgane)/mini možganska kap ali angina pektoris ali ovira do krvnih žil, srca ali možganov
wheezing, difficulty breathing or swallowing (potentially fatal) ▪ Swelling, blistering or peeling of the skin ▪ Acute kidney failure ▪ Hepatitis (inflamed liver) ▪ Inflammation of the gullet (oesophagus) ▪ Inflammation of the pancreas (can lead to stomach pain) 
izpuščaj na koži, otekanje obraza, ustnic ali jezika, ki lahko povzroči piskajoče ali težko dihanje ali požiranje - to se pojavi redko
• sodium chloride 4.5 mg/ml (0.45%) and glucose 50 mg/ml (5%) solution for injection/infusion 
• 0,45 % (4,5 mg/ml) raztopino natrijevega klorida in 5 % (50 mg/ml) raztopino glukoze za injiciranje/infundiranje
Renal failure, 
Ledvična okvara
Dynastat 40 mg powder and solvent for solution for injection 
Dynastat 40 mg prašek in vehikel za raztopino za injiciranje
Dynastat 40 mg powder and solvent for solution for injection parecoxib 
Dynastat 40 mg prašek in vehikel za raztopino za injiciranje parekoksib
MA (EU) Number Invented name Strength Pharmaceutical Form Route of Administration 
Izmišljeno ime Jakost Farmacevtska oblika Pot uporabe
2 vials +2 pre-filled syringes +2 plunger rods + 2 vial adapters + 2 needles 
2 viali + 2 napolnjeni injekcijski brizgi + 2 bata brizge + 2 adapterja viale + 2 igli
3 x (1 vial + 1 prefilled syringe + 1 plunger rod + 1 vial adapter + 1 needle) (multipack) 
3 x (1 viala + 1 napolnjena injekcijska brizga + 1 bat brizge + 1 adapter viale + 1 igla) (skupno pakiranje)
1 vial + 1 pre-filled syringe + 1 plunger rod + 1 vial adapter + 1 needle 
1 viala + 1 napolnjena injekcijska brizga + 1 bat brizge + 1 adapter viale + 1 igla
The maximum dose is one tablet of the highest strength (80/10 mg) once a day. 
Največji dovoljeni odmerek je ena tableta najvišje jakosti (80/10 mg) enkrat na dan.