qanastek/EMEA-V3 huggingface dataset:
Dynastat must not be given to women during the last three months of pregnancy or to breast-feeding women.
Dynastat m’ għandux jingħata lil nisa tqas matul l- aħħar tliet xhur tat- tqala tagħhom lin- nisa li jkunu qed ireddgħu.
It must not be used after coronary bypass surgery.
M’ għandux jintuża wara kirurġija tal- bypass koronarja.
Why has Dynastat been approved?
Għaliex ġie approvat Dynastat?
The Committee for Medicinal Products for Human Use (CHMP) decided that Dynastat’ s benefits are greater than its risks for the short-term treatment of postoperative pain.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Dynastat huma ikbar mir- riskji tiegħu fit- trattament fil- qosor tal- uġigħ ta ’ wara l- operazzjoni.
The Committee recommended that Dynastat be given marketing authorisation.
Il - Kumitat irrakkomanda li Dynastat jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Dynastat:
Tagħrif ieħor dwar Dynastat:
The European Commission granted a marketing authorisation valid throughout the European Union for Dynastat on 22 March 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Dynastat fit- 22 ta ’ Marzu 2002.
The marketing authorisation holder is Pfizer Limited.
Id- detentur tal- awtorizzazzjoni għat- tqegħid fis- suq huwa Pfizer Limited.
The marketing authorisation was renewed on 22 March 2007.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 22 ta ’ Marzu 2007.
The full EPAR for Dynastat is available here.
L- EPAR sħiħ għal Dynastat huwa disponibbli minn hawnhekk.
This summary was last updated in 02-2009.
Dan is- sommarju ġie aġġornat l- aħħar f’ 02- 2009.
Dynastat 20 mg powder for solution for injection
Dynastat 20 mg trab għal soluzzjoni għall- injezzjoni.
20 mg vial:
Fjala ta ’ 20 mg:
Each vial contains 20 mg parecoxib (present as 21.18 mg parecoxib sodium) for reconstitution.
Kull fjala fiha 20 mg parecoxib (preżenti kwantu għal 21. 18 mg parecoxib sodium) għar- rikostituzzjoni.
After reconstitution, the final concentration of parecoxib is 20 mg/ ml.
Wara r- rikostituzzjoni, l- konċentrazzjoni finali ta ’ parecoxib hija ta ’ 20 mg/ ml.
When reconstituted in sodium chloride 9 mg/ ml (0.9%) solution, Dynastat contains approximately 0.22 mEq of sodium per vial.
Meta rikostitwit f’ soluzzjoni ta ’ 9 mg/ ml (0. 9%) ta ’ sodium chloride, Dynastat ikun fih bejn wieħed u ieħor 0. 22 mEq ta ’ sodium f ’ kull fjala '.
Powder for solution for injection White to off-white powder.
Trab abjad ikanġi fl- offwajt.
For the short-term treatment of postoperative pain.
Għal kura mhux fit- tul kontra l- uġigħ ta ’ wara operazzjoni.
The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks (see sections 4.3 and 4.4).
Id- deċiżjoni li jiġi preskritt inibitur selettiv ta ’ COX- 2 għandha tkun ibbażata fuq valutazzjoni tar - riskji ġenerali tal- pazjent individwali (ara sezzjonijiet 4. 3 u 4. 4).
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.
Id- doża rakkomandata hija ta ’ 40 mg mgħotija fil- vina (IV) jew ġol- muskolu (IM), segwita minn kull 6 sigħat sa 12- il siegħa b’ 20 mg jew 40 mg skond il- bżonn, mingħajr ma wieħed jeċċedi t- 80 mg kuljum.
The IV bolus injection may be given rapidly and directly into a vein or into an existing IV line.
L- injezzjoni IV bolus tista ’ tiġi amministrata malajr u direttament ġol- vina jew ġo tubu IV eżistenti.
The IM injection should be given slowly and deeply into the muscle (see section 6.6 for instructions for reconstitution).
L- injezzjoni IM għandha tingħata bil- mod il- mod u fil- fond tal- muskolu (ara sezzjoni 6. 6 għall- istruzzjonijiet għar- rikostituzzjoni).
Concomitant Use with Opioid Analgesics:
Użu flimkien ma ’ analġeżiċi opioid:
Opioid analgesics can be used concurrently with parecoxib, dosing as described in the paragraph above.
Analġeżiċi opioid jistgħu jintużaw fl- istess żmien ma ’ parecoxib, b’ dużaġġ hekk kif inhu deskritt fil- paragrafu ta ’ hawn fuq.
In all clinical assessments parecoxib was administered at a fixed time interval whereas the opioids were administered on as needed basis (PRN).
Fl- assessjar kliniku kollu, parecoxib kien mgħoti b’ interval fiss ta ’ ħin, filwat li l- analġeżiċi opioid ingħataw skond il- bżonn (PRN).
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.
Minħabba li r- risju kardjovaskolari ta ’ l- inibituri speċifiċi ta ’ cyclooxygenase- 2 (COX- 2), jista jiżdied mad- doża u mat- tul ta ’ żmien ta ’ esposizzjoni, għandha tingħata l- iktar doża baxxa effettiva, għall - inqas tul ta ’ żmien possibli.
Precipitation may occur when Dynastat is combined in solution with other medicinal products and therefore Dynastat must not be mixed with any other drug, either during reconstitution or injection.
Preċipitazzjoni tista ’ sseħħ meta Dynastat jitħallat f’ soluzzjoni ma ’ prodotti mediċinali oħra u għalhekk Dynastat m’ għandux jitħallat ma ’ xi mediċina oħra, kemm matul ir- rikostituzzjoni kif ukoll waqt l- injezzjoni.
In those patients where the same IV line is to be used to inject another medicinal product, the line must be adequately flushed prior to and after Dynastat injection with a solution of known compatibility.
F’ dawk il- pazjenti fejn l- istess linja IV għandha tintuża sabiex jiġi injettat prodott mediċinali ieħor, il- linja għandha tiġi mlaħalħa sewwa qabel u wara l- injezzjoni ta ’ Dynastat b’ soluzzjoni li hija magħrufa li hija kompatibili.
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
Kompatibilità tas- soluzzjoni f’ linja IV Wara rikostituzzjoni b’ solventi aċċettabbli, Dynastat jista ’ jiġi injettat biss IV jew IM, jew f’ linji IV bl- għoti ta ’: soluzzjoni ta ’ 9 mg/ ml (0. 9%) ta ’ sodium chloride
2 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
2 soluzzjoni għall- infużjoni ta ’ 50 g/ l (5%) ta ’ glucose soluzzjoni għall- injezzjoni ta ’ 4. 5 mg/ ml (0. 45%) ta ’ sodium chloride u ta ’ 50 g/ l (5%) ta ’ glucose soluzzjoni għall- injezzjoni ta ’ Ringer- Lactate
Injection into an IV line delivering glucose 50 g/ l (5%) in Ringer-Lactate solution for injection, or other IV fluids not listed above, is not recommended as this may cause precipitation from solution.
Injezzjoni f’ linja IV li tagħti 50 g/ l (5%) ta ’ glucose f’ soluzzjoni għall- injezzjoni ta ’ Ringer- Lactate, jew ta ’ fluwidi IV oħra mhux imniżżla hawn fuq, m’ hiex rikmandata minħabba li din tista ’ tikkawża preċipitazzjoni minn soluzzjoni.
However, for elderly patients weighing less than 50 kg, initiate treatment with half the usual recommended dose of Dynastat and reduce the maximum daily dose to 40 mg (see section 5.2).
Ġeneralment ma jkun hemm bżonn ta ’ l- ebda aġġustament fid- doża f’ pazjenti anzjani (≥ 65 sena). Iżda f’ dawk il- pazjenti li l- piż tagħhom huwa inqas minn 50 Kg, ibda l- kura b’ nofs id- doża ta ’ Dynastat normalment rakkomandata u naqqas id- doża massima ta ’ kuljum għal 40 mg (ara sezzjoni 5. 2) Indeboliment tal- Fwied:
Introduce Dynastat with caution and at half the usual recommended dose in patients with moderate hepatic impairment (Child-Pugh score 7-9) and reduce the maximum daily dose to 40 mg.
Ġeneralment ma jkunx hemm bżonn ta ’ l- ebda aġġustament fid- doża f’ pazjenti li għandhom indeboliment ħafif tal- fwied (Child- Pugh skala 5 - 6). F’ pazjenti li għandhom indeboliment moderat tal -- fwied ibda l- kura b’ Dynastat b’ ċerta kawtela u b’ nofs id- doża normalment rakkomandata (Child- Pughs Skala 7 - 9) u naqqas id- doża massima ta ’ kuljum għal 40 mg.
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).
Peress li ma hemmx esperjenza klinika f’ pazjenti li għandhomindeboliment serju ħafna tal- fwied (Child - Pughskala > 9), l- użu tiegħu mhuwiex rakkomandat f’ dawn il- pazjenti (Ara sezzjoni 4. 3 u 5. 2).
Renal Impairment:
Indeboliment renali:
On the basis of pharmacokinetics, no dosage adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance of 30-80 ml/ min.).
Fuq bażi farmakokinetika, ma hemm bżonn ta ’ l- ebda aġġjustament fid- doża, f’ pazjenti li għandhom indeboliment renali ħafif għal moderat (clearance ta ’ Creatinine ta ’ 30 sa 80 ml/ min).
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).
F’ pazjenti li għandhom indeboliment renali serju ħafna (clearance ta ’ Creatinine < 30 ml/ min) jew f’ pazjenti li jistgħu ikunu predisposti li jżommu l- fluwidi, parecoxib għandu jinbeda bl- inqas doża rrikmandata, u l- funzjoni tal- kliewi tal- pazjent għandha tkun immonitorjata sew (ara sezzjoni 4. 4 u 5. 2).
Children and adolescents:
Tfal u Adoloxxenti:
There is no experience in children and adolescents.
M’ hemmx esperjenza dwar l- użu fit- tfal u l- adoloxxenti.
Therefore, its use is not recommended in these patients.
Għalhekk l- użu tiegħu mhuwiex rakkomandat fuq dawn il- pazjenti.
4.3 Contraindications
4. 3 Kontra- indikazzjonijet
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).
Passat ta ’ reazzjoni allerġika serja ta ’ kwalunkwe tip għall- mediċina, b’ mod speċjali reazzjonijiet fuq il- ġilda bħas- sindrome Stevens- Johnson, nekroliżi epidermali tossika, eritema multiforme jew pazjenti b’ sensittività eċċessiva għal sulphonamides (ara sezzjonijiet 4. 4 u 4. 8).
Active peptic ulceration or gastrointestinal (GI) bleeding.
Ulċera attiva fis- sistema diġestiva jew fsada gastro- intestinali (GI)
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.
Pazjenti li sofrew spażmu fil- bronki, rinite akuta, polipi nażali, edema anġjonewrotika, urtikarja u reazzjonijiet ta ’ natura allerġika (oħrajn), wara li jkun ġie amministrat lilhom acetylsalicylic acid jew NSAIDs jew impedituri selettivi cyclooxygenase (COX- 2) oħra.
The third trimester of pregnancy and breast-feeding (see sections 4.6 and 5.3).
It- tielet trimestru tat- tqala u treddigħ mis- sider (ara sezzjoni 4. 6 u 5. 3).
Severe hepatic dysfunction (serum albumin < 25 g/ l or Child-Pugh score ≥ 10).
Indeboliment serju ħafna tal- fwied (albumina fis- serum < 25 g/ l jew punteġġ Child- Pugh ≥ 10).
Inflammatory bowel disease.
Mard infjammatorju fil- musrana.
Congestive heart failure (NYHA II-IV).
Insuffiċjenza tal- qalb konġestiva (NYHA III- IV)
Treatment of post-operative pain following coronary artery bypass graft (CABG) surgery (see sections 4.8 and 5.1).
Trattament ta ’ uġigħ ta ’ wara operazzjoni wara kirurġija li tinvolvi coronary artery bypass graft (CABG) (ara s- sezzjonijiet 4. 8 u 5. 1).
Established ischaemic heart disease, peripheral arterial disease and/ or cerebrovascular disease.
Mard tal- qalb iskemiku stabbilit, mard arterjali periferali u/ jew mard ċerebrovaskulari.
There is limited clinical experience with Dynastat treatment beyond three days.
L- esperjenza klinika ta ’ kura b ’ Dynastat għal aktar minn tliet ijiem, hija limitata.
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).
Minħabba l- possibiltà li jkun hemm żieda fir- reazzjonijiet avversi meta jittieħdu dożi akbar ta ’ parecoxib, impedituri COX- 2 oħra u NSAIDs, il- pazjenti li jkunu qed jingħataw il- kura b’ parecoxib għandhom ikunu osservati wara li tiżdiedilhom id- doża u, fl- assenza ta ’ żieda fl- effikaċja, għandhom jiġu kkunsidrati għażliet terapewtiċi oħra (ara sezzjoni 4. 2).
COX-2 inhibitors have been associated with increased risk of cardiovascular and thrombotic adverse events when taken long term.
Inibituri ta ’ COX- 2 ġew assoċjati ma ’ riskju akbar ta ’ episodji avversi kardjovaskulari u trombotiċi meta meħudin fuq perjodu ta ’ żmien twil.
The exact magnitude of the risk associated with a single dose has not been determined, nor has the exact duration of therapy associated with increased risk.
L- ammont preċiż ta ’ riskju assoċjat ma ’ doża waħda għadu ma ġiex stabbilit, lanqas ma ġie stabbilit it- tul preċiż tat- terapija assoċjata ma ’ żieda fir- riskju.
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).
Pazjenti b’ fatturi ta ’ riskju sinifikanti għal episodji kardjovaskulari (eż. pressjoni għolja, hyperlipidimia, dijabete mellitus, tipjip) għandhom jiġu ttrattati biss b ’ parecoxib sodium wara li tkun tqieset b’ attenzjoni (ara sezzjoni 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).
Għandhom jittieħdu miżuri adegwati u l- waqfien tat- terapija b’ parecoxib għandu jiġi kkunsidrat jekk ikun hemm biżżejjed evidenza klinika ta ’ deterjorazzjoni fil- kundizzjoni ta ’ sintomi kliniċi speċifiċi f’ dawn il- pazjenti (ara sezzjoni 5. 1).
Dynastat has not been studied in cardiovascular revascularization procedures other than coronary artery bypass graft procedures.
Dynastat ma ġiex studjat fi proċeduri ta ’ rivaskularizzazzjoni kardjovaskulari għajr proċeduri ta ’ coronary artery bypass graft.
Studies in other surgeries than CABG procedures included patients with ASA (American Society of Anaesthesiology) Physical Status Class I-III only.
Studji f’ kirurġiji oħra għajr proċeduri CABG inkludew pazjenti bi Status Fiżiku ta ’ ASA (Soċjetà Amerikana ta ’ Anestesjoloġija) ta ’ Klassi I- III biss.
COX-2 inhibitors are not a substitute for acetylsalicylic acid for prophylaxis of cardiovascular thrombo-embolic diseases because of their lack of antiplatelet effects.
Inibituri ta ’ COX- 2 mhumiex sostituti għal acetylsalicylic acid għal profilassi ta ’ mard kardjovaskulari trombo- emboliku minħabba n- nuqqas ta ’ effetti kontra il- plejtlits, li għandhom.
Therefore, antiplatelet therapies should not be discontinued (see section 5.1).
Għalhekk, terapiji kontra il- plejtlits ma għandhomx jitwaqqfu (ara sezzjoni 5. 1).
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.
Kumplikazzjonijiet fil- parti gastro- intestinali ta ’ fuq [tiċrit, ulċeri jew fsada (PUBs)], li xi wħud minnhom wasslu għall- mewt - seħħew fuq pazjenti li kienu qed jiġu kkurati b’ parecoxib. - Għandha tintuża l- attenzjoni meta tingħata kura lil pazjenti li huma l- aktar f’ riskju li jiżviluppaw komplikazzjonijiet gastro- intestinali b’ NSAIDs jew acetylsalicylic acid fl- istess żmien tal- kura jew pazjenti li għandhom passat mediku ta ’ mard gastro- intestinali, bħal ulċeri u fsada GI.
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).
Hemm żieda fir- riskju ta ’ effetti avversi gastro- intestinali (ulċera gastrointestinali jew kumplikazzjonijiet gastrointestinali oħra), meta parecoxib sodium jittieħed flimkien ma ’ acetylsalicylic acid (anke f’ dożi żgħar).
Dynastat has been studied in dental, orthopaedic, gynaecologic (principally hysterectomy) and coronary artery bypass graft surgery.
Dynastat ġie studjat f’ kirurġija dentali, ortopedika, ġinekoloġika (l- aktar fl- isterektomija) u fil - kirurġija coronary artery bypass graft.
There is little experience in other types of surgery, for example gastrointestinal or urological surgery.
Ftit hemm esperjenza f’ tipi ta ’ kirurġiji oħra, bħal per eżempju dawk gastro- intestinali u uroloġiċi.
Serious skin reactions, including erythema multiforme, exfoliative dermatitis and Stevens-Johnson syndrome have been reported through post-marketing surveillance in patients receiving parecoxib.
Reazzjonijiet serji fil- ġilda, inkluż eritema multiforme, dermatite bi tqaxxir fil- ġilda u s- sindrome Stevens- Johnson ġew irrapportati permezz ta ’ sorveljanza wara t- tqegħid fis- suq f’ pazjenti li kienu qegħdin jirċievu parecoxib.
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).
Barra minn hekk, reazzjonijiet serji tal- ġilda, uħud minnhom fatali, inkluż nekroliżi epidermali tossika, ġew irrapportati f’ sorveljanza wara t- tqegħid fis- suq f’ pazjenti li kienu qegħdin jirċievu valdecoxib (il- metabolit attiv ta ’ parecoxib) u dawn ma jistgħux jiġu eliminati għal parecoxib.
Patients appear to be at highest risk for these reactions early in the course of therapy; the onset of the reaction occurring in the majority of cases within the first month of treatment.
Jidher li l- pazjenti jkunu l- aktar fir- riskju għal dawn ir- reazzjonijiet kmieni fil- kors ta ’ terapija, il- bidu tar- reazzjoni sseħħ fil- maġġoranza tal- każijiet matul l- ewwel xahar tat- trattament.
Appropriate measures should be taken by physicians to monitor for any serious skin reactions with therapy, e. g. additional patient consultations.
Għandhom jittieħdu miżuri xierqa mit- tobba sabiex jimmonitorjaw kull każ serju ta ’ reazzjoni fil- ġilda b’ terapija eż. konsultazzjonijiet addizzjonali mal- pazjenti.
Patients should be advised to immediately report any emergent skin condition to their physician.
Il- pazjenti għandhom jiġu avżati sabiex jirrapportaw minnufih lit- tabin kull kundizzjoni fil- ġilda li tfeġġ.
Parecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Parecoxib għandu jitwaqqaf ma ’ l- ewwel feġġa ta ’ raxx tal- ġilda, feriti bil- mukus, jew ma ’ kwalunkwe sinjal ieħor ta ’ sensittività eċċessiva.
Serious skin reactions are known to occur with NSAIDs including COX-2 selective inhibitors as well as other medications.
Reazzjonijiet serji tal- ġilda huma magħrufin li jseħħu b’ NSAIDs
4 selective inhibitors.
4 inkluż inibituri selettivi ta ’ COX- 2 kif ukoll medikazzjonijiet oħra.
Patients with a history of sulphonamide allergy may be at greater risk of skin reactions (see section 4.3).
Pazjenti b’ passat ta ’ allerġija b’ sulfonamid jistgħu jkunu f’ riskju akbar għal reazzjonijiet tal- ġilda (ara Sezzjoni 4. 3).
Patients without a history of sulphonamide allergy may also be at risk for serious skin reactions.
Pazjenti mingħajr passat ta ’ allerġija għal sulphonamide ukoll jistgħu jkunu f’ riskju għal reazzjonijiet serji tal- ġilda.
Hypersensitivity reactions (anaphylaxis and angioedema) have been reported in post-marketing experience with valdecoxib and parecoxib (see section 4.8).
Ġew rapportati reazzjonijiet ta ’ sensittività eċċessiva (anafilassi u anġjoedema) b’ valdecoxib u parecoxib fiż- żmien wara li l- prodott ħareġ fis- suq (ara sezzjoni 4. 8).
Some of these reactions have occurred in patients with a history of allergic-type reactions to sulphonamides (see section 4.3).
Xi wħud minn dawn ir - reazzjonijiet seħħew f’ pazjenti li għandhom passat mediku ta ’ reazzjonijiet ta ’ natura allerġika għas - sulfonamidi (ara sezzjoni 4. 3).
Parecoxib should be discontinued at the first sign of hypersensitivity.
Parecoxib għandu jitwaqqaf ma ’ l- ewwel sinjal ta ’ sensittività eċċessiva.
Acute renal failure has been reported through post-marketing surveillance in patients receiving parecoxib (see section 4.8).
Indeboliment reali serju ġie rrappurtat permezz ta ’ sorveljanza wara l- ħruġ fis- suq tal- prodott f’ pazjenti li kienu qegħdin jirċievu parecoxib (ara sezzjoni 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.
Peress li l- inibizzjoni ta ’ sinteżi ta ’ prostaglandin tista ’ tħassar il- funzjoni renali u tikkawża retenzjoni ta ’ fluwidu, għandha tintuża kawtela meta Dynastat jiġi amministrat f’ pazjenti li għandhom indeboliment renali (ara sezzjoni 4. 2), jew b’ ipertensjoni, jew f’ pazjenti b’ kundizzjoni kardijaka jew tal- kliewi kompromessa jew kundizzjonijiet oħra li jippredisponu ir- retenzjoni ta ’ fluwidu.
Caution should be used when initiating treatment with Dynastat in patients with dehydration.
Għandha tintuża kawtela meta tinbeda l- kura b’ Dynastat f’ pazjenti li jkunu diżidratati.
In this case, it is advisable to rehydrate patients first and then start therapy with Dynastat.
F’ dan il- każ, huwa rakkomandat li l- ewwel il- pazjent jitfejjaq min- nixfa u wara tinbeda l- kura b’ Dynastat.
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.
Jekk matul trattament, pazjenti jmorru għall- agħar fir- rigward ta ’ kwalunkwe episodju tal- funzjoni ta ’ l- organi deskritt hawn fuq, għandhom jittieħdu miżuri adegwati u t- twaqqif tat- terapija b’ parecoxib sodium għandu jiġi kkunsidrat.
Dynastat may mask fever and other signs of inflammation (see section 5.1).
Dynastat jista jaħbi d- deni u sinjali oħra ta ’ infjammazzjoni (ara sezzjoni 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).
F’ każi iżolati, ġie deskritt aggravar ta ’ infezzjonijiet fit- tessuti rotob waqt użu ta ’ Dynastat b’ konnessjoni ma ’ l- użu tal - NSAIDs u fi studji mhux kliniċi (ara sezzjoni 5. 3).
Caution should be exercised with respect to monitoring the incision for signs of infection in surgical patients receiving Dynastat.
L- inċiżjoni għandha tkun eżaminata bir- reqqa għal- sinjali ta ’ infezzjoni, f’ pazjenti li kellhom intervent kirurġiku u li jkunu qed jiġu kurati b’ Dynastat.
Caution should be exercised when co-administering Dynastat with warfarin and other oral anticoagulants (see section 4.5).
Għandha tintuża l- attenzjoni meta Dynasat jittieħed ma ’ warfarin u mediċinai kontra l- koagulazzjoni oħra li jittieħdu mill- ħalq( ara sezzjoni 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).
Bħal kull prodott mediċinali li jimpedixxi cyclooxyngenase/ sintesi ta ’ prostaglandin, l- użu ta ’ Dynastat mhuwiex rakkomandat għal nisa li qed jippruvaw biex ikollhom it- tfal (ara sezzjoni 4. 6 u 5. 1).
Interaction studies have only been performed in adults.
Studji ta ’ interazzjoni twettqu biss f’ adulti.
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.
Interazzjonijiet Farmakodinamiċi Terapija kontra l- koagulazzjoni tad- demm għandha tiġi sorveljata b’ mod partikolari matul l- ewwel ġranet minn meta tinbeda l- kura b’ Dynastat, f’ pazjenti li tkun qed tiġi amministrata lilhom warfarin jew mediċini kontra l- koagulazzjoni oħra, peress li dawn il- pazjenti għandhom riskju akbar ta ’ kumplikazzjoni ta ’ fsada.
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).
Għalhekk pazjenti li jkunu qed jingħataw mediċini kontra l- koagulazzjoni mill- ħalq għandhom ikunu osservati mill- qrib għall- ħin prothrombin INR, speċjalment fl- ewwel ftit ġranet meta l- kura b’ parecoxib tinbeda jew tinbidel id- doża ta ’ parecoxib (ara sezzjoni 4. 4).
Dynastat had no effect on acetylsalicylic acid-mediated inhibition of platelet aggregation or bleeding times.
Dynastat ma għandu l- ebda effett fuq l- inibizzjoni ta ’ l- aggregazzjoni ta ’ plejtlets, medjata permezz ta ’ acetylsalicylic acid jew fuq perijodi ta ’ fsada.
Clinical trials indicate that Dynastat can be given with low dose acetylsalicylic acid (≤ 325 mg).
5 ma ’ doża baxxa ta ’ acetylsalicylic acid (≤ 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).
Fl- istudji li ġew sottomessi,, bħal ma ġara fil- każ ta ’ NSAIDs oħra, ġiet ippruvata żieda fl- ulċerazzjoni gastro- intestinali jew kumplikazzjonijiet gastro - intestinali oħra mqabbla ma ’ l- użu ta ’ parecoxib waħdu meta ġie amministrat miegħu L- acetylsalicylic acid f’ dożi żgħar (ara sezzjoni 5. 1)
Co-administration of parecoxib sodium and heparin did not affect the pharmacodynamics of heparin (activated partial thromboplastin time) compared to heparin alone.
L- amministrazzjoni flimkien ta ’ parecoxib sodium u heparin m ’ affettwawx il- farmakodinamika ta ’ heparin (ħin tat- tromboplastina parzjalment attivata) kif imqabbla ma ’ heparin waħidha.
5 NSAIDs may reduce the effect of diuretics and antihypertensive medicinal products.
In- NSAIDs jistgħu jnaqqsu l- effett tad- dijuretiċi u prodotti mediċinali anti- ipertensivi.
As for NSAIDs, the risk of acute renal insufficiency may be increased when ACE inhibitors or diuretics are co- administered with parecoxib sodium.
Għal dak li jirrigwarda n- NSAIDs ir- riskju ta ’ insuffiċjenza renali akuta jista ’ jiżdied meta impediturii ACE jew dijuretiċi jiġu amministrati flimkien ma ’ parecoxib sodium.
Co-administration of NSAIDs and cyclosporin or tacrolimus has been suggested to increase the nephrotoxic effect of cyclosporin and tacrolimus.
L- amministrazzjoni flimkien ta ’ NSAIDs u cyclosporin jew tacrolimus ġiet issuġgerita sabiex iżżid l- effett nekrotossiku ta ’ l- istess cyclosporin u tacrolimus.
Renal function should be monitored when parecoxib sodium and any of these medicinal products are co-administered.
Il- funzjoni renali għandha tiġi sorveljata meta parecoxib sodium u xi wieħed minn dawn il- prodotti mediċinali jkunu amministrati flimkien.
Dynastat may be co-administered with opioid analgesics.
Dynastat jista jiġi amministrat ma ’ analġeżiċi opioid.
In clinical trials, the daily requirement for PRN opioids was significantly reduced when coadministered with parecoxib.
Fi studji kliniċi, il- bżonn ta ’ opioids PRN kuljum kien sostanzjalment mnaqqas meta mgħoti ma ’ parecoxib.
Effects of other medicinal products on the pharmacokinetics of parecoxib (or its active metabolite valdecoxib) Parecoxib is rapidly hydrolysed to the active metabolite valdecoxib.
Effetti ta ’ prodotti mediċinali oħra fuq il- farmakokinetika ta ’ parecoxib (jew valdecoxib metabolu attiv tiegħu) Parecoxib huwa idrolożżat malajr għal metabolu attiv valdecoxib.
In humans, studies demonstrated that valdecoxib metabolism is predominantly mediated via CYP3A4 and 2C9 isozymes.
Fil- bniedem, studji wrew li l- metaboliżmu ta ’ valdecoxib huwa l- aktar medjat permezz ta ’ isożemi CYP3A4 u 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.
Dan jindika li d - doża ta ’ parecoxib sodium għandha titnaqqas f’ dawk il- pazjenti li qegħdin jieħdu l- kura b’ fluconazole.
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.
Madankollu, fil- biċċa l- kbira, m’ għandux ikun hemm bżonn ta ’ bidla fid- dożaġġ għal dawk il- pazjenti li jkunu qed jieħdu ketoconazole.
The effect of enzyme induction has not been studied.
L- effett ta ’ l- induzzjoni ta ’ l- enżimi ma ġiex studjat.
The metabolism of valdecoxib may increase when co-administered with enzyme inducers such as rifampicin, phenytoin, carbamazepine or dexamethasone.
Il- metaboliżmu ta ’ valdecoxib jista ’ jiżdied meta dan ikun amministrat flimkien ma ’ prodotti li jinduċu l- enżimi bħal rifampicin, phenytoin, carbamazepine jew dexamethasone.
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).
Effett ta ’ parecoxib (jew valdecoxib metabolu attiv tiegħu) fuq il- farmakokinetiċi ta ’ prodotti mediċinali ohra.
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).
Il- kura b’ valdecoxib (40 mg darbtejn kuljum għal 7 tijiem) ikkawżat żieda ta ’ tlett darbiet aktar fil - konċentrazzjonijiet fil- plażma ta ’ dextrometorphan (sustrat ta ’ CYP2DS). Għalhekk wieħed għandu juża kawtela meta jkun qed jagħti flimkien Dynastat u prodotti mediċinali li huma primarjament metaboliżżati bis- CYP2DS u li għandhom effetti terapewtiċi marġinali dojoq (eż. flecainide, 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.
L- esponiment tal- plażma ta ’ omeprazole (sustrat ta ’ CYP2C19) 40 mg darba kuljum, ġie miżjud b’ 46% wara l- amministrazzjoni ta ’ valdecoxib 40 mg darbtejn kuljum għal 7 ijiem, filwaqt li l- esponiment tal- plażma għal- valdecoxib ma ġiex affettwat.
Therefore, caution should be observed when administering Dynastat with medicinal products known to be substrates of CYP2C19 (e. g. phenytoin, diazepam, or imipramine).
Dawn ir- riżultati jindikaw illi għalkemm valdecoxib mhuwiex metabolizzat bis- CYP2C19, jista ’ jkun impeditur ta ’ din l - iżoenżima. Għalhekk wieħed għandu juża kawtela meta jagħti Dynastat ma ’ prodotti mediċinali magħrufa bħala sustrati ta ’ CYP2C19 (ez. phenytoin, diazepam jew imipramina).
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.
Madankollu sorveljanza kif jixraq
However, adequate monitoring of methotrexate-related toxicity should be considered when co-administering these two medicinal products.
6 tat- tossiċità relatata ma ’ methotrexate, għandha tigi kunsidrata meta wieħed ikun qed jagħti dawn iż - żewg prodotti mediċinali flimkien.
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.
L- amministrazzjoni ta ’ valdecoxib u lithium irriżulta fi tnaqqis sinifikanti fil- clearance mis- serum ta ’ lithium (25%) u clearance renali (30%) b’ esponiment ogħla b’ 34% fis- serum meta mqabbel ma ’ lithium waħdu.
Lithium serum concentration should be monitored closely when initiating or changing parecoxib sodium therapy in patients receiving lithium.
Il- konċentrazzjoni fis- serum ta ’ lithium għandu jiġi sorveljat bl- attenzjoni meta wieħed jibda jew ibiddel terapija ta ’ parecoxib sodium, f’ pazjenti li qed jingħataw lithium.
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.
L- amministrazzjoni ta ’ valdecoxib flimkien ma ’ glibenclamide (sustrat ta ’ CYP3A4) ma affettwatx la l- farmakokinetiċi (esponiment) u lanqas il- farmakodinamiċi (livelli ta ’ glucose fid- demm u ta ’ l - insulina) ta ’ glibenclamide.
6 Injectable anaesthetics:
Anestetiċi li jistgħu jiġu injettati:
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.
L- amministrazzjoni flimkien ta ’ 40 mg IV parecoxib sodium u propofol (sustrat ta ’ CYP2C9) jew midazolam (sustrat ta ’ CYP3A4) ma effettwax la l- farmakokinetiċi (metaboliżmu u esponiment) u l- anqas il- farmakodinamiċi (effetti EEG, testijiet psikomuturi u qawmien mis- sedazzjoni) ta ’ l- IV propofol u IV midażolam.
Additionally, coadministration of valdecoxib had no clinically significant effect on the hepatic or intestinal CYP 3A4-mediated metabolism of orally administered midazolam.
Barra minn hekk hekk l- amministrazzjoni ma ’ valdecoxib ma kellu l- ebda effett kliniku sinifikanti fuq il- metaboliżmu tal- fwied jew dak intestinali, medjat bis- CYP3A4, ta ’ midazolam li jittieħed mill- ħalq.
Administration of IV parecoxib sodium 40 mg had no significant effect on the pharmacokinetics of either IV fentanyl or IV alfentanil (CYP3A4 substrates).
L- amministrazzjoni ta ’ 40 mg IV parecoxib sodium ma kellha l- ebda effett sinifikanti fuq il- farmakokinetiċi ta ’ L- IV fentanyl jew IV alfentanil (sustrati ta’ CYP3A4).
Inhalation anaesthetics:
Anestetiċi li jittieħdu man- nifs:
No formal interaction studies have been done.
Ma sarux studji formali fuq l- interazzjoni.
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).
Fi studji kirurġiċi fejn parecoxib sodium ġie amministrat qabel operazzjoni, ma ġie nnutat l- ebda sinjal ta ’ interazzjoni farmakodinamika f’ pazjenti li kienu qed jingħataw parecoxib sodium u l- aġenti nitrous oxide u isoflurane, li huma anestetiċi li jittieħdu man- nifs. (ara sezzjoni 5. 1).
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).
Hemm suspetti li parecoxib sodium jikkawża difetti serji fit- twelid meta mogħti matul l- aħħar tliet xhur tat- tqala, għax bħal fil- każ ta ’ prodotti oħra mediċinali li huma magħrufa li jinibixxu s- sinteżi ta ’ prostaglandin, jista ’ jikkawża l- għeluq prematur tad- ductus arteriosus u inerzja ta ’ l- utru (ara Sezzjonijiet 4. 3, 5. 1 u 5. 3).
Dynastat is contraindicated (see section 4.3) in the last trimester of pregnancy.
Dynastat huwa kontraindikat (ara sezzjoni 4. 3) matul l- aħħar tliet xhur tat- tqala.
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).
Bħal prodotti mediċinali oħra li jinibixxu l- COX- 2, Dynastat mhuwiex rakkomandat għal nisa li qed jippruvaw biex ikollhom it- tfal (ara sezzjonijiet 4. 4, 5. 1 u 5. 3).
There are no adequate data from the use of parecoxib sodium in pregnant women or during labour.
M’ hemmx biżżejjed informazzjoni mill- użu ta ’ parecoxib sodium fin- nisa tqal jew waqt il- ħlas.
Studies in animals have shown reproductive toxicity (see sections 5.1 and 5.3).
Studji fuq bhejjem urew ħsara fuq is- sistema riproduttiva (ara sezzjonijiet 5. 1 u 5. 3).
Dynastat should not be used during the first two trimesters of pregnancy unless clearly necessary (i. e. the potential benefit to the patient outweighs the potential risk to the foetus).
Dynastat m’ għandux jintuża matul l- ewwel żewġ trimestri tat- tqala ħlief meta hemm bżonn speċifiku (jiġifieri l- benefiċċju potenzjali fil- pazjenta jkun ikbar mir- riskju potenzjali fuq il- fetu).
Parecoxib, valdecoxib (its active metabolite) and a valdecoxib active metabolite are excreted in the milk of rats.
Parecoxib, valdecoxib (il- metabolu attiv tiegħu) u l- metabolu attiv valdecoxib joħorġu mal- ħalib tal - firien.
It is not known whether valdecoxib is excreted in human milk.
Mhuwiex magħruf jekk valdecoxib joħroġx mal- ħalib tal- bniedem.
Dynastat should not be administered to women who breast-feed (see sections 4.3 and 5.3).
Dynastat m’ għandux jiġi amministrat lil nisa li qed ireddgħu (ara sezzjonijiet 4. 3 u 5. 3).
No studies on the effect of Dynastat on the ability to drive or use machines have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
However, patients who experience dizziness, vertigo or somnolence after receiving Dynastat should refrain from driving or operating machines.
Iżda pazjenti li jsofru minn sturdament, vertigo jew tħeddil, wara li jiġi amministrat lilhom Dynastat, m’ għandhomx isuqu jew iħaddmu magni.
4.8 Undesirable effects
7 4. 8 Effetti mhux mixtieqa
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà tagħhom.
Of the Dynastat treated patients in controlled trials, 1962 were patients with post-surgical pain.
1962 mill pazjenti li ngħataw il- kura b’ Dynasat fi provi kkontrollati, kienu pazjenti li kellhom uġigħ ta ’ wara operazzjoni kirurġika..
The following undesirable effects had a rate greater than placebo and have been reported among 1543 patients administered Dynastat 20 or 40 mg as a single or multiple dose (up to 80 mg/ day) in 12 placebo controlled studies, including dental, gynaecologic, orthopaedic surgery or coronary artery bypass graft surgery as well as pre-operative administration in dental and orthopaedic surgeries.
L- effetti mhux mixtieqa imsemmija hawn taħt kellhom rata akbar mill- plaċebo u ġew rappurtati fost 1543 pazjent li ngħata l- kura bi 20 jew 40 mg Dynastat f’ doża singola jew f’ diversi dożi (sa 80 mg/ kuljum) fi 12- il studju kontrollat bil- plaċebo, li jinkludu kirurġiji dentali, ġinekoloġici, ortopediċi jew coronary artery bypass graft, kif ukoll l- amministrazzjoni qabel l- operazzjoni f’ operazzjonijiet dentali u ortopediċi.
The discontinuation rate due to adverse events in these studies was 5.0% for patients receiving Dynastat and 4.3% for patients receiving placebo.
F’ dawn l- istudji r- rata ta ’ twaqqif minħabba effetti avversi, kienet ta ’ 0. 5% f’ pazjenti b’ Dynastat u 4. 3% f’ pazjenti bil- plaċebo.
7 [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)]
[Komuni ħafna (> 1/ 10), Komuni ((≥1/ 100, < 1/ 10) Mhux komuni (≥1/ 1000, < 1/ 100) Rari (≥1/ 10, 000, < 1/ 1000) Rari ħafna (< 1/ 10, 000) mhux magħruf (ma jistax jiġi stmat mit- tagħrif disponibbli)]
Infections and infestations Uncommon: abnormal sternal serous wound drainage, wound infection.
Infezzjonijiet u impestazzjonijiet Mhux komuni: tnixxija anormali u serja ta ’ materja minn ferita sternali, infezzjoni tal- ferita
Blood and lymphatic system disorders Common: post-operative anaemia Uncommon: thrombocytopenia
Disturbi tad- demm u tas- sistema limfatika Komuni: anemija ta ’ wara operazzjoni Mhux komuni: tromboċitopenja
Metabolism and nutrition disorders Common: hypokalaemia
Disturbi tal- metaboliżmu u nutrizzjoni Komuni: ipokalemija
Common: agitation, insomnia
Disturbi prikjatriċi Komuni: aġitazzjoni, nuqqas ta ’ rqad
Nervous system disorders Common: hypoaesthesia Uncommon: cerebrovascular disorder
Disturbi tas- sistema nervuża Komuni: ipoesteżja, Mhux komuni: disturbi ċerebrovaskolari
Cardiac disorders Uncommon: bradycardia
Disturbi tal- qalb Mhux komuni: bradikardja
Vascular disorders Common: hypertension, hypotension Uncommon: aggravated hypertension
Disturbi vaskulari Komuni: ipertensjoni, ipotensjoni Mhux komuni: ipertensjoni aggravata
Respiratory, thoracic and mediastinal disorders Common: respiratory insufficiency, pharyngitis
Disturbi respiratorju, toraċiku u medjastinali Komuni: insuffiċjenza respiratorja, farinġite
Gastrointestinal disorders Common: alveolar osteitis (dry socket), dyspepsia, flatulence Uncommon: gastroduodenal ulceration
Disturbi gastro- intestinali Komuni: ostejite alvejolari (dry socket), dispepsja, gass fl- istonku Mhux komuni: ulċerazzjoni gastro- duwodenali
Skin and subcutaneous tissue disorders Common: pruritus Uncommon: ecchymosis
Disturbi tal- ġilda u tessuti ta ’ taħtha Komuni: prurite Mhux komuni: ekkimożi
Musculoskeletal and connective tissue disorders Common: back pain
Disturbi muskolu- skeletriċi u tat- tessut konnettiv Komuni: uġigħ fid- dahar
Renal and urinary disorders Common: oliguria
8 Disturbi tal- kliewi u tas- sistema urinarja Komuni: oligurja
General disorders and administration site conditions Common: peripheral oedema
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jittieħed Komuni: edema periferali
SGOT increased, SGPT increased, blood urea nitrogen increased.
Stħarriġ Komuni: żieda fil- krejatinina fid- demm Mhux komuni: żieda f ’ SGOT, żieda f’ SGPT, żieda f’ BUN
The following rare, serious adverse events have been reported in association with the use of NSAIDs and cannot be ruled out for Dynastat: bronchospasm and hepatitis.
L- effetti avversi li ġejjin ġew rapportati meta kien hemm l- użu ta ’ NSAIDs u ma jistgħux jiġu esklużi fl- użu ta ’ Dynastat: insuffiċjenza akuta renali, insuffiċjenza tal- qalb konġestiva, spażmu fil- bronki u epatite.
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 8 wound healing complications.
Wara coronary artery bypass graft pazjenti li jkun ġie amministrat lilhom Dynastat, jista ’ jkollhom riskju ogħla ta ’ effetti avversi, bħal episodji kardjovaskulari/ trmoboemboliċi, infezzjonijiet kirurġiċi fil - fond u kumplikazzjoni fil- fejqan ta ’ ferita sternali.
Cardiovascular/ thromboembolic events include myocardial infarction, stroke/ TIA, pulmonary embolus and deep vein thrombosis (see section 4.3 and 5.1).
Episodji kardjovaskulari/ tromboemboliċi jinkludu infart mijokardjali, puplesija/ TIA, embolu pulmonary u trombożi fil- vini profonda (ara sezzjonijiet 4. 3 u 5. 1).
In post-marketing experience, the following reactions have been reported in association with the use of parecoxib:
Fl’ esperjenza li nkisbet wara li Dynastat tpoġġa fis- suq, ġew irrapportati r- reazzjonijiet li ġejjin b’ assoċjazzjoni ma ’ l- użu ta ’ parecoxib:
Rare: acute renal failure, renal failure, myocardial infarction, congestive heart failure, abdominal pain, nausea, vomiting, dyspnoea, tachycardia and Stevens-Johnson syndrome.
Rari: indeboliment renali serju, indeboliment renali, infart mijokardijaku, insufiċjenza tal- qalb konġestiva, uġigħ addominali, dardir, rimettar, dispnea, takikardja u s- sindrome Stevens- Johnson.
Very rare: erythema multiforme, exfoliative dermatitis and hypersensitivity reactions including anaphylaxis and angioedema (see section 4.4).
Rari ħafna: eritema multiforme, dermatite bi tqaxxir fil- ġilda u reazzjonijiet ta ’ sensittività eċċessiva inkluż anafilassi u anġjoedima (ara sezzjoni 4. 4).
In post marketing experience, the following reaction has been reported in association with the use of valdecoxib, and cannot be ruled out for parecoxib: toxic epidermal necrolysis (see section 4.4).
Wara li Dynastat tpoġġa fis- suq gew rapportati r- reazzjonijiet segwenti, assoċjati ma ’ l- użu ta ’ valdecoxib u ma jistgħux jiġu eliminati għal parecoxib: reazzjonijiet anafilattiċi, anġjo- edema, infart mijokardijaku (rari ħafna), eritema multiforma, dermatite esfoljattiva, sindromu Stevens- Johnson u nekroliżi tossika epidermali (ara sezzjoni 4. 4).
No case of parecoxib overdose has been reported.
L- ebda każ ta ’ doza eċċessiva ta ’ parecoxib ma ġie rrapurtat.
Valdecoxib is not removed by haemodialysis.
F’ kaz ta ’ doza eċċessiva, l- pazjenti għandhom jigu mogħtija kura sintomatika u ta ’ appoġġ. Valdecoxib ma jġix imneħħi bid- dijaliżi tad- demm.
Diuresis or alkalisation of urine may not be useful due to high protein binding of valdecoxib.
Dijureżi jew alkalizzazzjoni ta ’ l- urina tista ’ ma tkunx ta ’ utilità minħabba r- rabta għolja mal- proteini ta ’ valdecoxib.
Coxib, ATC code:
Coxib, Kodiċi ATC:
Parecoxib is a prodrug of valdecoxib.
Parecoxib huwa prodrug ta ’ valdecoxib.
Valdecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor within the clinical dose range.
Fil- firxa tad- dożi kliniċi, valdecoxib huwa impeditur selettiv cyclooxygenase- 2 (COX- 2).
Cyclooxygenase is responsible for generation of prostaglandins.
Cyclooxygenase hu responsabbli għall- ġenerazzjoni tal- prostaglandini.
Two isoforms, COX-1 and COX-2, have been identified.
Żewġ iżoformi, COX- 1 u COX- 2, ġew identifikati.
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 hija l- iżoforma ta ’ l- enżima li tiġi ndotta minn stimulazzjonijiet pro- infjammatorji u li ġiet akkreditata bħala primarjament responsabbli għas - sintesi ta ’ medjaturi prostanojdi ta ’ l- uġigħ, infjammazzjoni u deni.
COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and central nervous system functions (fever induction, pain perception and cognitive function).
COX- 2 hi nvoluta wkoll fl - ovulazzjoni, impjantazzjoni u fl- għeluq tad- ductus arteriosus, fir- regolazzjoni tal- funzjoni renali, u fil - funzjonijiet tas- sistema nervuża ċentrali (ħruġ ta ’ deni, perċezzjoni ta ’ l- uġigħ u l- funzjoni konjittiva).
It may also play a role in ulcer healing.
Jista ’ jkollha wkoll rwol fil- fejqan ta ’ l- ulċeri.
COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established.
COX- 2 ġiet identifikata fit- tessuti ta ’ madwar ulċeri fl - istonku fil- bniedem, iżda r- relevanza tagħha fil- fejqan ta ’ dawn l- ulċeri għadha ma ġietx stabbilita.
The difference in antiplatelet activity between some COX-1 inhibiting NSAIDs and COX-2 selective inhibitors may be of clinical significance in patients at risk of thrombo-embolic reactions.
9 Id- differenza fl- attività ta ’ kontra l- plejtlets ta ’ bejn xi NSAIDs li jimpedixxu COX- 1 u mpedituri selettivi COX- 2 tista ’ tkun ta ’ sinifikat kliniku f’ pazjenti li għandhom riskju ta ’ reazzjonijiet trombo - embolitiċi.
COX-2 selective inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane.
Impedituri selettivi COX- 2 inaqqsu l- formazzjoni ta ’ prostasiklin sistematiku (u allura possibilment ta ’ l- endotilju) mingħajr ma jaffettwa l- plejtlet thromboxane.
The clinical relevance of these observations has not been established.
Ir- relevanza klinika ta ’ dawn l- osservazzjonijiet ma ġietx stabbilita.