natgillin/translations-raw huggingface dataset:
Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
Preobčutljivost za zdravilno učinkovino ali za katerokoli pomožno snov (glejte poglavje 6. 1).
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 sulphonamides (see sections 4.4 and 4.8).
Stevens - Johnsonovega sindroma, toksične epidermalne nekrolize, multiformnega eritema ali bolniki z znano preobčutljivostjo za sulfonamide (glejte poglavji 4. 4. in 4. 8).
Active peptic ulceration or gastrointestinal (GI) bleeding.
Zdravilo je kontraindicirano:
Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
zaviralci COX- 2 (ciklooksigenaze- 2), doživeli bronhospazem, akutni rinitis, nosne polipe, angionevrotski edem, urtikarijo ali druge alergijske reakcije;
The third trimester of pregnancy and breast-feeding (see sections 4.6 and 5.3).
- v tretjem trimesečju nosečnosti in obdobju dojenja (glejte poglavji 4. 6 in 5. 3),
Severe hepatic dysfunction (serum albumin < 25 g/ l or Child-Pugh score ≥ 10).
- za bolnike s hudo disfunkcijo jeter (albumin v serumu < 25 g/ l ali ocena ≥ 10 po Child- Pughu),
Inflammatory bowel disease.
- za bolnike s črevesno vnetno boleznijo,
Congestive heart failure (NYHA II-IV).
- za bolnike s kongestivnim srčnim popuščanjem (NYHA II- IV),
Treatment of post-operative pain following coronary artery bypass graft (CABG) surgery (see sections 4.8 and 5.1).
- zdravljenje pooperacijske bolečine CABG (operativna vstavitev presadka koronarnega obvoda)
Established ischaemic heart disease, peripheral arterial disease and/ or cerebrovascular disease.
- potrjena ishemična srčna bolezen, bolezen perifernih arterij in/ ali cerebrovaskularna bolezen
There is limited clinical experience with Dynastat treatment beyond three days.
Kliničnih izkušenj z več kot tridnevno uporabo Dynastata je malo.
Because of the possibility for increased adverse reactions at higher doses 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).
COX-2 inhibitors have been associated with increased risk of cardiovascular and thrombotic adverse events when taken long term.
Dolgotrajna uporaba zaviralcev COX- 2 je bila povezana s povečanim tveganjem za srčnožilne in trombotične neželene učinke.
Patients with significant risk factors for cardiovascular events (e. g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with parecoxib sodium after careful consideration (see section 5.1).
Bolnike s pomembnimi dejavniki tveganja za srčnožilne dogodke (npr. hipertenzija, hiperlipidemija, diabetes mellitus, kajenje) lahko zdravimo z natrijevim parekoksibatom le po skrbnem premisleku (glejte poglavje 5. 1).
Appropriate measures should be taken and discontinuation of parecoxib therapy should be considered if there is clinical evidence of deterioration in the condition of specific clinical symptoms in these patients (see section 5.1).
Če se pri teh bolnikih pojavijo klinični znaki poslabšanja specifičnih kliničnih simptomov, je treba ustrezno ukrepati in razmisliti o prekinitvi zdravljenja s parekoksibom (glejte poglavje 5. 1).
Dynastat has not been studied in cardiovascular revascularization procedures other than coronary artery bypass graft procedures.
Dynastat razen v študijo operacij obvodov koronarne arterije (CABG), ni bil vključen v nobeno drugo študijo kardiovaskularnih kirurških postopkov revaskularizacije.
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 CABG, so vključevale le bolnike s kliničnim statusom ASA (ASA - American Society of Anaesthesiology), razreda I- III.
COX-2 inhibitors are not a substitute for acetylsalicylic acid for prophylaxis of cardiovascular thrombo-embolic diseases because of their lack of antiplatelet effects.
Ker selektivni zaviralci COX- 2 nimajo antiagregacijskega delovanja, niso nadomestilo za acetilsalicilno kislino v profilaksi kardiovaskularnih trombemboličnih bolezni.
Therefore, antiplatelet therapies should not be discontinued (see section 5.1).
Zato antiagregacijske terapije ne smemo ukiniti (glejte poglavje 5. 1).
Upper gastrointestinal 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.
Caution is advised in the treatment of patients most at risk of developing a gastrointestinal complication with NSAIDs; the elderly, patients using any other NSAID or acetylsalicylic acid concomitantly or patients with a prior history of gastrointestinal disease, such as ulceration and GI bleeding.
Med zdravljenjem je potrebna previdnost pri bolnikih, ki jih ob uporabi nesteroidnih protivnetnih zdravil najbolj ogrožajo zapleti na prebavilih, pri starejših, pri bolnikih, ki sočasno jemljejo kakšno drugo nesteroidno protivnetno zdravilo ali acetilsalicilno kislino, in pri bolnikih z anamnezo bolezni prebavil, npr. razjede ali krvavitve v prebavilih.
There is further increase in the risk of gastrointestinal adverse effects (gastrointestinal ulceration or other gastrointestinal complications), when parecoxib sodium is taken concomitantly with acetylsalicylic acid (even at low doses).
Tveganje za neželene učinke v prebavilih (razjeda v prebavilih ali drugi gastrointestinalni zapleti), se še dodatno poveča, kadar se parekoksib uporablja sočasno z acetilsalicilno kislino (celo pri majhnih odmerkih).
Dynastat has been studied in dental, orthopaedic, gynaecologic (principally hysterectomy) and coronary artery bypass graft surgery.
Dynastat so preučevali pri stomatoloških, ortopedskih in ginekoloških (predvsem histerektomiji) operacijah in obvodni operaciji koronarnih arterij.
Serious skin reactions, including erythema multiforme, exfoliative dermatitis and Stevens-Johnson syndrome have been reported through post-marketing surveillance in patients receiving parecoxib.
V pomarketinških raziskavah so pri bolnikih, ki so prejemali parekoksib, poročali o hudih kožnih reakcijah, vključno z multiformnim eritemom, eksfoliativnim dermatitisom in Stevens- Johnsonovim sindromom.
Additionally, serious skin reactions, some of them fatal, including 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 pomarketinških raziskavah pri bolnikih, ki so prejemali valdekoksib (aktivni presnovek parekoksiba), poročali o resnih kožnih reakcijah, tudi takih s smrtnim izidom, vključno s toksično epidermalno nekrolizo; pojava le- teh ni mogoče izključiti pri uporabi parekoksiba (glejte poglavje 4. 8).
Appropriate measures should be taken by physicians to monitor for any serious skin reactions with therapy, e. g. additional patient consultations.
Zdravnik mora ustrezno ukrepati, da lahko nadzira morebitne resne kožne reakcije med terapijo, npr. z dodatnimi kontrolami bolnika.
Parecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Znano je, da se med uporabo nesteroidnih protivnetnih zdravil,
Serious skin reactions are known to occur with NSAIDs including COX-2 selective inhibitors as well as other medications.
4 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
Toda, kot kaže, je opisani delež resnih kožnih reakcij večji pri valdekoksibu (aktivnem presnovku parekoksiba) kot pri drugih selektivnih zaviralcih COX- 2.
Patients with a history of sulphonamide allergy may be at greater risk of skin reactions (see section 4.3).
Pri bolnikih z anamnezo alergije na sulfonamid, obstaja večje tveganje za pojav kožnih reakcij (glejte poglavje 4. 3).
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 po pridobitvi dovoljenja za promet poročajo o reakcijah preobčutljivosti (anafilaksa in angioedem) (glejte poglavje 4. 8).
Some of these reactions have occurred in patients with a history of allergic-type reactions to sulphonamides (see section 4.3).
Nekaj teh reakcij se je pojavilo pri bolnikih, ki so imeli reakcije alergijskega tipa na sulfonamide (glejte poglavje 4. 3).
Acute renal failure has been reported through post-marketing surveillance in patients receiving parecoxib (see section 4.8).
Med raziskavami po pridobitvi dovoljenja za promet so pri bolnikih, ki so prejemali parekoksib, poročali o akutni odpovedi ledvic (glejte poglavje 4. 8).
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 Dynastat uporabljati previdno pri bolnikih z oslabelim delovanjem ledvic (glejte poglavje 4. 2), hipertenzijo ali oslabelim delovanjem srca, jeter ali drugimi stanji, ki povečujejo zastajanje tekočine.
Caution should be used when initiating treatment with Dynastat in patients with dehydration.
Previdnost je potrebna, ko uvajamo zdravljenje z Dynastatom pri dehidriranih bolnikih.
In this case, it is advisable to rehydrate patients first and then start therapy with Dynastat.
Te bolnike je priporočljivo najprej rehidrirati in šele potem začeti zdravljenje z Dynastatom.
Dynastat should be used with caution in patients with moderate hepatic dysfunction (Child-Pugh score 7-9) (see section 4.2).
Dynastat moramo previdno uporabljati tudi pri bolnikih z zmerno disfunkcijo jeter (ocena od 7 do 9 po Child- Pughu) (glejte poglavje 4. 2).
If during treatment, patients deteriorate in any of the organ system functions described above, appropriate measures should be taken and discontinuation of parecoxib sodium therapy should be considered.
Če se med zdravljenjem poslabša delovanje kateregakoli organskega sistema, opisanega zgoraj, je treba uvesti ustrezne ukrepe in razmisliti o ukinitvi zdravljenja z natrijevim parekoksibatom.
Dynastat may mask fever and other signs of inflammation (see section 5.1).
Dynastat lahko prikrije zvišano telesno temperaturo in druge znake vnetja (glejte poglavje 5. 1).
In isolated cases, an aggravation of soft tissue infections has been described in connection with the use of NSAIDs and in nonclinical studies with Dynastat (see section 5.3).
Pri posameznikih so v zvezi z nesteroidnimi protivnetnimi zdravili in v nekliničnih raziskavah z Dynastatom opisali poslabšanje okužbe mehkih tkiv (glejte poglavje 5. 3).
Caution should be exercised with respect to monitoring the incision for signs of infection in surgical patients receiving Dynastat.
Kirurškim bolnikom, zdravljenim z Dynastatom, je treba iz previdnosti nadzirati operacijsko rano glede na prisotnost znakov okužbe.
Caution should be exercised when co-administering Dynastat with warfarin and other oral anticoagulants (see section 4.5).
Previdnost je potrebna pri sočasni uporabi Dynastata in varfarina ali drugih peroralnih antikoagulansov (glejte poglavje 4. 5).
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 4.6 and 5.1).
Tako kot drugih zdravil, ki zavirajo ciklooksigenaze/ sintezo prostaglandinov, tudi Dynastata ni priporočljivo uporabljati pri ženskah, ki načrtujejo nosečnost (glejte poglavji 4. 6 in 5. 1).
Interaction studies have only been performed in adults.
Študije medsebojnega delovanja so bile opravljene le pri odraslih bolnikih.
Pharmacodynamic interactions 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.
Te bolnike bolj ogrožajo hemoragični zapleti.
Therefore, patients receiving oral anticoagulants should be closely monitored for their prothrombin time INR, particularly in the first few days when therapy with parecoxib is initiated or the dose of parecoxib is changed (see section 4.4).
INR, zlasti v prvih dneh po začetku zdravljenja s parekoksibom ali spremembi njegovega odmerka (glejte poglavje 4. 4).
Dynastat had no effect on acetylsalicylic acid-mediated inhibition of platelet aggregation or bleeding times.
Dynastat ne vpliva na zavrtje agregacije trombocitov ali čas krvavitev, povezanih z acetilsalicilno kislino.
Clinical trials indicate that Dynastat can be given with low dose acetylsalicylic acid (≤ 325 mg).
Klinične raziskave kažejo, da je Dynastat mogoče uporabljati hkrati z majhnim odmerkom acetilsalicilne kisline (≤325 mg).
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 raziskavah 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).
Co-administration of parecoxib sodium and heparin did not affect the pharmacodynamics of heparin (activated partial thromboplastin time) compared to heparin alone.
5 Sočasna uporaba natrijevega parekoksibata in heparina ni vplivala na farmakodinamiko heparina (aktivirani delni tromboplastinski čas) v primerjavi z dajanjem samega heparina.
5 NSAIDs may reduce the effect of diuretics and antihypertensive medicinal products.
Nesteroidna protivnetna zdravila lahko zmanjšajo učinek diuretikov in antihipertenzivnih zdravil.
As for NSAIDs, the risk of acute renal insufficiency may be increased when ACE inhibitors or diuretics are co- administered with parecoxib sodium.
Tako kot pri nesteroidnih protivnetnih zdravilih se lahko tudi med sočasno uporabo zaviralcev ACE ali diuretikov in natrijevega parekoksibata poveča tveganje za akutno ledvično insuficienco.
Co-administration of NSAIDs and cyclosporin or tacrolimus has been suggested to increase the nephrotoxic effect of cyclosporin and tacrolimus.
Sočasna uporaba nesteroidnih protivnetnih zdravil in ciklosporina ali takrolimusa naj bi povečala nefrotoksični učinek ciklosporina in takrolimusa.
Renal function should be monitored when parecoxib sodium and any of these medicinal products are co-administered.
Med sočasno uporabo natrijevega parekoksibata s katerim od teh zdravil je treba nadzirati delovanje ledvic.
Dynastat may be co-administered with opioid analgesics.
Dynastat se lahko uporablja sočasno z opioidnimi analgetiki.
Effects of other medicinal products on the pharmacokinetics of parecoxib (or its active metabolite valdecoxib) Parecoxib is rapidly hydrolysed to the active metabolite valdecoxib.
Vpliv drugih zdravil na farmakokinetiko parekoksiba (ali njegovega aktivnega presnovka valdekoksiba) Parekoksib se hitro hidrolizira v aktivni presnovek valdekoksib.
In humans, studies demonstrated that valdecoxib metabolism is predominantly mediated via CYP3A4 and 2C9 isozymes.
Raziskave so dokazale, da presnova valdekoksiba pri ljudeh poteka pretežno s pomočjo izoencimov CYP3A4 in 2C9.
Plasma exposure (AUC and Cmax) to valdecoxib was increased (62% and 19%, respectively) when co- administered with fluconazole (predominantly a CYP2C9 inhibitor), indicating that the dose of parecoxib sodium should be reduced in those patients who are receiving fluconazole therapy.
Plazemska izpostavljenost (AUC in Cmaks) valdekoksibu se je med sočasno uporabo flukonazola (ki zavira predvsem CYP2C9) povečala (AUC za 62% in Cmaks za 19%); kar kaže, da je treba pri bolnikih, ki dobivajo flukonazol, odmerek natrijevega parekoksibata zmanjšati.
Plasma exposure (AUC and Cmax) to valdecoxib was increased (38% and 24%, respectively) when co- administered with ketoconazole (CYP3A4 inhibitor), however, a dosage adjustment should not generally be necessary for patients receiving ketoconazole.
Plazemska izpostavljenost (AUC in Cmaks) valdekoksibu se je med sočasno uporabo ketokonazola (zaviralca CYP3A4) povečala (AUC za 38% in Cmaks za 24%), vendar bolnikom, ki prejemajo ketokonazol, odmerka praviloma ni treba prilagajati.
Effect of parecoxib (or its active metabolite valdecoxib) on the pharmacokinetics of other medicinal products Treatment with valdecoxib (40 mg twice daily for 7 days) produced a 3-fold increase in plasma concentrations of dextromethorphan (CYP2D6 substrate).
Vpliv parekoksiba (ali njegovega aktivnega presnovka valdekoksiba) na farmakokinetiko drugih zdravil Zdravljenje z valdekoksibom (40 mg dvakrat na dan 7 dni) je povzročilo 3- kratno povečanje koncentracije dekstrometorfana (substrata CYP2D6) v plazmi.
Therefore, caution should be observed when co-administering Dynastat and medicinal products that are predominantly metabolised by CYP2D6 and which have narrow therapeutic margins (e. g. flecainide, propafenone, metoprolol).
Zato je potrebna previdnost med sočasno uporabo Dynastata in zdravil, ki se presnavljajo pretežno s CYP2D6 in imajo ozko terapevtsko območje (npr. flekainid, propafenon, metoprolol).
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.
Therefore, caution should be observed when administering Dynastat with medicinal products known to be substrates of CYP2C19 (e. g. phenytoin, diazepam, or imipramine).
Zato je potrebna previdnost med uporabo Dynastata z zdravili, za katera je znano, da so substrati CYP2C19 (npr. fenitoin, diazepam ali imipramin).
In interaction studies in rheumatoid arthritis patients receiving weekly methotrexate intramuscularly, orally administered valdecoxib (40 mg twice daily) did not have a clinically significant effect on the plasma concentrations of methotrexate.
V raziskavah o medsebojnem delovanju pri bolnikih z revmatoidnim artritisom, ki so enkrat na teden dobivali metotreksat intramuskularno, peroralno dan valdekoksib (40 mg dvakrat na dan) ni klinično pomembno vplival na koncentracijo metotreksata v plazmi.
However, adequate monitoring of methotrexate-related toxicity should be considered when co-administering these two medicinal products.
Vendar je treba med sočasno uporabo obeh zdravil ustrezno spremljati z metotreksatom povezane toksične učinke.
Co-administration of valdecoxib and lithium produced significant decreases in lithium serum clearance (25%) and renal clearance (30%) with a 34% higher serum exposure compared to lithium alone.
Sočasna uporaba valdekoksiba in litija je povzročila pomembno zmanjšanje serumskega (25%) in ledvičnega očistka (30%) litija, tako da se je serumska izpostavljenost v primerjavi s samim litijem povečala za 34%.
Lithium serum concentration should be monitored closely when initiating or changing parecoxib sodium therapy in patients receiving lithium.
Če uvedemo ali spremenimo zdravljenje z natrijevim parekoksibatom pri bolnikih, ki dobivajo litij, je treba koncentracijo litija v serumu natančno nadzorovati.
6 Injectable anaesthetics:
6 Anestetiki za injiciranje:
Coadministration of IV parecoxib sodium 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 natrijevega parekoksibata 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.
Additionally, coadministration of valdecoxib had no clinically significant effect on the hepatic or intestinal CYP 3A4-mediated metabolism of orally administered midazolam.
Poleg tega sočasna uporaba valdekoksiba ni klinično pomembno vplivala na jetrno ali črevesno presnovo (posredovano s CYP3A4) peroralno uporabljenega midazolama..
Administration of IV parecoxib sodium 40 mg had no significant effect on the pharmacokinetics of either IV fentanyl or IV alfentanil (CYP3A4 substrates).
Uporaba intravenskega natrijevega parekoksibata v odmerku 40 mg ni pomembno vplivala na farmakokinetiko intravenskega fentanila ali intravenskega alfentanila (substratov CYP3A4).
Inhalation anaesthetics:
Inhalacijski anestetiki:
No formal interaction studies have been done.
Formalnih raziskav o medsebojnem delovanju niso opravili.
In surgery studies in which parecoxib sodium was administered pre-operatively, no evidence of pharmacodynamic interaction was observed in patients receiving parecoxib sodium and the inhalation anaesthetic agents nitrous oxide and isoflurane (see section 5.1).
V kirurških raziskavah, v katerih so natrijev parekoksibat uporabili pred operacijo, niso pri bolnikih, ki so dobivali natrijev parekoksibat in inhalacijska anestetika dušikov oksid in izofluran, ugotovili nobenih farmakodinamičnih interakcij (glejte poglavje 5. 1).
Pregnancy:
Nosečnost Pri uporabi v zadnjem trimesečju nosečnosti lahko natrijev parekoksibat povzroči hude okvare ploda, ker lahko – tako kot druga zdravila, ki zavirajo sintezo prostaglandinov – povzroči prezgodnje zaprtje ductusa arteriosusa ali inertnost maternice (glejte poglavja 4. 3, 5. 1 in 5. 3).
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).
Like other medicinal products that inhibit COX-2, Dynastat is not recommended in women attempting to conceive (see sections 4.4, 5.1 and 5.3).
Tako kot za druga zdravila, ki zavirajo COX- 2, tudi za Dynastat ni priporočljiva uporaba pri ženskah, ki načrtujejo nosečnost (glejte poglavja 4. 4, 5. 1 in 5. 3).
There are no adequate data from the use of parecoxib sodium in pregnant women or during labour.
O uporabi natrijevega parekoksibata pri nosečnicah in med porodom ni dovolj podatkov.
Studies in animals have shown reproductive toxicity (see sections 5.1 and 5.3).
Poskusi na živalih so pokazale reprodukcijsko toksičnost (glejte poglavji 5. 1 in 5. 3).