qanastek/EMEA-V3 huggingface dataset:
There were no significant differences between active treatments and placebo for any of the other pre- specified event categories (renal dysfunction/ failure, upper GI ulcer complications or surgical wound complications).
Ma kienx hemm differenzi sinifikanti bejn trattamenti attivi u plaċebo għal kwalunkwe kategorija oħra ta ’ avveniment speċifikata qabel (funzjonament ħażin/ indeboliment, renali, kumplikazzjonijiet b’ ulċeri GI fil- parti ta ’ fuq jew kumplikazzjonijiet f’ feriti kirurġiċi).
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
Fi prova ta ’ kirurġija ortopedika/ ġenerali maġġuri kbira (N=1050), pazjenti irċevew doża inizjali ta ’ parecoxib 40 mg IV, imbagħad 20 mg IV Q12H għal minimu ta ’ 3 ijiem u wara ngħataw valdecoxib PO (20 mg Q12H) (n=525) għall- bqija ta ’ perjodu ta ’ trattament ta ’ 10 ijiem, jew plaċebo IV segwit bi plaċebo PO (n=525).
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 sodium/ valdecoxib compared to placebo treatment in these post-surgical patients.
Ma kien hemm ebda differenzi sinifikanti fil - profil ta ’ sigurtà totali, inkluż l- erba ’ kategoriji ta ’ avvenimenti speċifikati qabel deskritti fuq għat - tieni studju tal- kirurġija CABG, għal parecoxib sodium/ valdecoxib meta mqabbel ma ’ trattament bi plaċebo f’ dawn il- pazjenti wara kirurġija.
Elimination of valdecoxib is by extensive hepatic metabolism involving multiple pathways, including cytochrome P 450 (CYP) 3A4 and CYP2C9 isoenzymes and glucuronidation (about 20%) of the sulphonamide moiety.
L- eliminazzjoni ta ’ valdecoxib issir permezz ta ’ metaboliżmu epatiku estensiv li tinvolvi diversi triqat, inkluż iċ- ċitokromju P 450 (CYP) 3A4 u
A hydroxylated metabolite of valdecoxib (via the CYP pathway) has been identified in human plasma that is active as a COX-2 inhibitor.
Metabolu hydroxylated ta ’ valdecoxib (permezz tal- pathway CYP) ġiet identifikata fi plażma umana li hija attiva bħala inibitur ta ’ COX- 2.
In healthy elderly subjects, the apparent oral clearance of valdecoxib was reduced, resulting in an approximately 40% higher plasma exposure of valdecoxib
F’ suġġetti anzjani b’ saħħithom, il- clearance apparenti ta ’ valdecoxib mill- ħalq kienet imnaqqsa, b’ riżultat ta ’ esponiment fil- plażma ta ’ valdecoxib madwar 40% ogħla meta mqabbla ma ’ suġġetti żagħżagħ b’ saħħithom.
Powder Disodium hydrogen phosphate Phosphoric acid and/ or sodium hydroxide (for pH adjustment).
Trab Dibasic sodium phosphate, heptahydrate Phosphoric acid u/ jew sodium hydroxide (biex jirranġa l- pH).
Solvent Sodium chloride Hydrochloric acid or sodium hydroxide (for pH adjustment) Water for injections.
Sodium chloride Hydrochloric acid jew sodium hydroxide (biex jirranġa l- pH) Ilma għall- injezzjonijiet.
25 Dynastat and opioids should not be administered together in the same syringe.
Dynastat u opjojdi m’ għandhomx jiġu amministrati flimkien fl- istess siringa.
Do not inject Dynastat into an IV line delivering any other drug.
Tinjettax Dynastat f’ linja IV li qed tipprovdi xi mediċina oħra.
For storage conditions of the reconstituted medicinal product see section 6.3.
Għal kundizzjonijiet ta ’ ħażna tal- prodott mediċinali rikostitwit ara sezzjoni 6. 3.
6.5 Nature and contents of container
28 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Dynastat is supplied as a sterile, single unit-of-use vial that is packaged with a 2 ml ampoule with a fill volume of 1 ml sodium chloride 9mg/ ml (0.9%) solution (see below for various pack sizes and configurations).
Fjali 20 mg: fjali tal- ħġieġ bla kulur Tip Numru 1 (2 ml) b’ tapp laminat, issiġillat b’ għatu isfar li tiftħu b’ subgħajk (flip off) fuq kisja ta ’ l- aluminju.
3 x 3 pack: contains 3 vials of parecoxib 20 mg and 3 ampoule with 1 ml sodium chloride 9 mg/ ml (0.9%) solution.
Dynastat jinstab f’ pakketti ta ’ 10 fjali.
26 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Reconstitution solvents Reconstitute Dynastat 20 mg with 1 ml sodium chloride 9 mg/ ml (0.9%) solution.
Irrikostitwixxi Dynastat 20 mg bi 1 ml soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%).
The only other acceptable solvents for reconstitution are: 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
Glucose 50 g / l (5%) soluzzjoni għall- infużjoni sodium chloride 4. 5 mg/ ml (0. 45%) u Glucose 50 g / l (5%) soluzzjoni għall- injezzjoni.
Dynastat should be administered within 24 hours of reconstitution (see section 6.3), or discarded
Is- soluzzjoni m’ għandiex tiġi wżata jekk tkun tilfet il- kulur jew imqallba jew jekk wieħed jinnota xi frak.
The reconstituted product is isotonic.
Il- prodott rikostitwit huwa iżotoniku.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal - prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu.
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA) http: // www. emea. europa. eu
Dynastat 40 mg powder for solution for injection
Dynastat 40 mg trab għal soluzzjoni għall- injezzjoni.
Each vial contains 40 mg parecoxib (present as 42.36 mg parecoxib sodium) for reconstitution.
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 0.44 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. 44 mEq ta ’ sodium f’ kull fjala.
29 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
31 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 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
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).
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 (GI) gastrointestinal bleeding.
Ulċera attiva fis- sistema diġestiva jew fsada gastro- intestinali (GI)
Treatment of post-operative pain following coronary artery bypass graft (CABG) surgery (see section 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.
32 Mard tal- qalb iskemiku stabbilit, mard arterjali periferali u/ jew mard ċerebrovaskulari.
30 4.4 Special warnings and precautions for use
33 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
However, the reported rate of serious skin events
Madankollu, ir- rata rrapportata ta ’
31 appears to be greater for valdecoxib (the active metabolite of parecoxib) as compared to other COX-2 selective inhibitors.
34 episodji serji tal- ġilda tidher li hija ikbar għal valdecoxib (il- metabolit attiv ta ’ parecoxib) hekk kif imqabbel ma ’ inibituri selettivi oħra ta ’ COX- 2.
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).
35 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)
32 NSAIDs may reduce the effect of diuretics and antihypertensive medicinal products.
In- NSAIDs jistgħu jnaqqsu l- effett tad- dijuretiċi u prodotti mediċinali anti- ipertensivi.
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..
However, adequate monitoring of methotrexate-related toxicity should be considered when co-administering these two medicinal products.
36 tat- tossiċità relatata ma ’ methotrexate, għandha tigi kunsidrata meta wieħed ikun qed jagħti dawn iż - żewg prodotti mediċinali flimkien.
33 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.
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 oruterine 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 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 jew waqt il - ħlas ħlief meta hemm bżonn speċifiku (jiġifieri l- benefiċċju potenzjali fil- pazjenta jkun ikbar mir - riskju potenzjali fuq il- fetu).
4.8 Undesirable effects
37 4. 8 Effetti mhux mixtieqa
34 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.
[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)]
General disorders and administration site conditions Common: peripheral oedema
38 Komuni: oligurja
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
35 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 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 fondi u kumplikazzjoni fil- fejqan ta ’ ferita sternali.
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.
39 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.
36 Opioid-sparing Effects:
Effetti ta ’ tnaqqis fl- użu ta ’ Opioids:
In addition to routine adverse event reporting, pre-specified event categories, adjudicated by an independent expert committee, were examined in two placebo- controlled safety studies in which patients received parecoxib sodium for at least 3 days and then were transitioned to oral valdecoxib for a total duration of 10-14 days.
Il- pazjenti kollha rċevew analġeżija standard matul it- trattament.
All patients received standard of care analgesia during treatment Patients received low-dose acetylsalicylic acid prior to randomization and throughout the two CABG surgery studies.
Pazjenti rċevew doża baxxa ta ’ acetylsalicylic acid qabel it- tqassim b’ mod każwali u matul iż- żewġ studji ta ’ kirurġija CABG.
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).
Il- pazjenti tqassmu b’ mod każwali fi żmien 24 siegħa wara kirurġija CABG għal: doża inizjali ta ’ 40 mg parecoxib IV, imbagħad 20 mg IV Q12H għal mill - inqas 3 ijiem segwit bi valdecoxib PO (20 mg Q12H) (n=544) għall- bqija tal- perjodu ta ’ trattament ta ’ 10 ijiem; plaċebo IV segwit bi valdecoxib PO (n=544); jew plaċebo IV segwit bi plaċebo PO (n=548).
A significantly (p=0.033) greater incidence of events in the cardiovascular/ thromboembolic category was detected in the parecoxib / valdecoxib treatment group (2.0%) compared to the placebo/ placebo treatment group (0.5%).
40 Inkixfu ferm iktar inċidenzi (p=0. 033) ta ’ episodji fil- kategorija kardjovaskulari/ tromboemboliċi fil - grupp ta ’ trattament parecoxib / valdecoxib treatment group (2. 0%) meta mqabbel mal- grupp ta ’ trattament plaċebo/ plaċebo (0. 5%).
37 General Surgery:
Kirurġija ġenerali:
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).
Fi prova ta ’ kirurġija ortopedika/ ġenerali maġġuri kbira (N=1050), pazjenti irċevew doża inizjali ta ’ parecoxib 40 mg IV, imbagħad 20 mg IV Q12H għal minimu ta ’ 3 ijiem u wara ngħataw valdecoxib PO (20 mg Q12H) (n=525) għall- bqija ta ’ perjodu ta ’ trattament ta ’ 10 ijiem, jew plaċebo IV segwit bi plaċebo PO (n=525).
38 Elderly Subjects:
Pazjenti Anzjani:
Powder Disodium hydrogen phosphate Phosphoric acid and/ or sodium hydroxide (for pH adjustment).
42 Trab Dibasic sodium phosphate, heptahydrate Phosphoric acid u/ jew sodium hydroxide (biex jirranġa l- pH).
39 Use of Ringer-Lactate solution for injection or glucose 50 g/ l (5%) in Ringer Lactate solution for injection for reconstitution will cause the parecoxib to precipitate from solution and therefore is not recommended.
L- użu ta ’ soluzzjoni Ringer- Lactate għall- injezzjoni jew glucose 50 g/ l (5%) f’ soluzzjoni Ringer- Lactate għall- injezzjoni għar- rikostituzzjoni, iġġiegħel lil parecoxib jippreċipita u għalhekk mhuwiex rakkomandat.
This medicinal nproduct does not require special storing conditions prior to reconstitution.
Dan il- prodott mediċinali ma jeħtieġx kundizzjonijiet speċjali ta ’ ħażna qabel rikostituzzjoni.
Parecoxib sodium vials 40 mg vials:
Fjali ta ’ parecoxib sodium
Type I colourless glass vials (5 ml) with a laminated stopper, sealed with a purple flip- off cap on the aluminium overseal.
Fjali 20 mg: fjali tal- ħġieġ bla kulur Tip Numru 1 (2 ml) b’ tapp laminat, issiġillat b’ għatu vjola li tiftħu b’ subgħajk (flip off) fuq kisja ta ’ l- aluminju.
6.6 Special precautions for disposal and other handling.
43 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Reconstitution solvents Acceptable solvents for reconstitution of Dynastat are:
Solventi għar- rikostituzzjoni Solventi xierqa għar- rikostituzzjoni ta ’ Dynastat huma:
Reconstitution Process Use aseptic technique to reconstitute lyophilised parecoxib (as parecoxib sodium).
Uża teknika asettika biex tirrikostitwixxi parecoxib lajofilizzat (bħala parecoxib sodium).
Remove the purple flip-off cap to expose the central portion of the rubber stopper of the 40 mg parecoxib vial.
Neħħi l- kappa safra li jinfetaħ b’ subgħajk b’ mod li tesponi l- parti ċentrali tat- tapp tal- gomma tal- fjala 20 mg tal- parecoxib.
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 40 mg vial.
Iġbed permezz ta ’ labra sterili u siringa, 1ml ta ’ solvent xieraq u daħħal il- labra ġol- parti ċentrali tat- tapp tal- gomma, b’ mod li s- solvent jiġi trasferit ġol- fjala ta ’ 20 mg.
40 After reconstitution, Dynastat should be inspected visually for particulate matter and discoloration prior to administration.
Is- soluzzjoni hija ċara u bla kulur.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu.
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu
Dynastat 40 mg powder and solvent for solution for injection
Dynastat 40 mg trab u solvent għal soluzzjoni għall- injezzjoni
When reconstituted in sodium chloride 9 mg/ ml (0.9%) solution, Dynastat contains approximately 0.44 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. 44 mEq ta ’ sodium f ’ kull fjala.
Solvent: clear and colourless solution.
Solvent: soluzzjoni ċara u mingħajr kulur.
In all clinical assessments parecoxib was administered at a fixed time interval whereas the opioids were administered on as needs basis (PRN).
Fl- assessjar kliniku kollu, parecoxib kien mgħoti b’ interval fiss ta ’ ħin, filwat li l- analġeżiċi opioid ingħataw skond il- bżonn (PRN).
42 IV line solution compatibility After reconstitution with acceptable solvents, Dynastat may only be injected IV or IM, or into IV lines delivering: sodium chloride 9 mg/ ml (0.9%) solution glucose 50 g/ l (5%) solution for infusion sodium chloride 4.5 mg/ ml (0.45%) and glucose 50 g/ l (5%) solution for injection Ringer-Lactate solution for injection
46 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 soluzzjoni għall- infużjoni ta ’ 50 g/ l (5%) ta ’ glucose soluzzjoni għal injezzjoni ta ’ 4. 5 mg/ ml (0. 45%) ta ’ sodium chloride u ta ’ 50 g/ l (5%) ta ’ glucose soluzzjoni għal injezzjoni Ringer- Lactate
43 Established ischaemic heart disease, peripheral arterial disease and/ or cerebrovascular disease.
Mard tal- qalb iskemiku stabbilit, mard arterjali periferali u/ jew mard ċerebrovaskulari.
4.4 Special warnings and precautions for use
47 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
There is further increase in the risk of gastrointestinal adverse effects (gastrointestinal ulceration or other gastrointestinal complications), when parecoxib sodium istaken concomitantly with acetylsalicylic acid (even at low doses).
Hemm żieda fir- riskju ta ’ effetti avversi gastro- intestinali (ulċerazzjoni gastrointestinali jew kumplikazzjonijiet gastrointestinali oħra), meta parecoxib sodium jittieħed flimkien ma ’ acetylsalicylic acid (anke f’ dożi żgħar).
44 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.
Clinical trials indicate that Dynastat can be given with low dose acetylsalicylic acid (≤ 325 mg).
49 ma ’ doża baxxa ta ’ acetylsalicylic acid (≤ 325 mg).
45 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.
However, adequate monitoring of methotrexate-related toxicity should be considered when co-administering these two medicinal products.
50 tat- tossiċità relatata ma ’ methotrexate, għandha tigi kunsidrata meta wieħed ikun qed jagħti dawn iż - żewg prodotti mediċinali flimkien.
46 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.
4.8 Undesirable effects
51 4. 8 Effetti mhux mixtieqa
Within each frequency grouping, undesirable effect are presented in order of decreasing seriousness.
F’ kull sezzjoni ta frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà tagħhom.
47 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.
General disorders and administration site conditions Common: peripheral oedema
52 Komuni: oligurja
48 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.
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.
53 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.
49 Opioid-sparing Effects:
Effetti ta ’ tnaqqis fl- użu ta ’ Opioids:
A significantly (p=0.033) greater incidence of events in the cardiovascular/ thromboembolic category was detected in the parecoxib / valdecoxib treatment group (2.0%) compared to the placebo/ placebo treatment group (0.5%).
54 Inkixfu ferm iktar inċidenzi (p=0. 033) ta ’ episodji fil- kategorija kardjovaskulari/ tromboemboliċi fil - grupp ta ’ trattament parecoxib / valdecoxib treatment group (2. 0%) meta mqabbel mal- grupp ta ’ trattament plaċebo/ plaċebo (0. 5%).
50 General Surgery:
Kirurġija ġenerali:
51 Elderly Subjects:
Pazjenti Anzjani:
Powder Disodium hydrogen phosphate Phosphoric acid and/ or sodium hydroxide (for pH adjustment).
56 Trab Dibasic sodium phosphate, heptahydrate Phosphoric acid u/ jew sodium hydroxide (biex jirranġa l- pH).
52 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
Dynastat is supplied as a sterile, single unit-of-use vial that is packaged with a 2 ml ampoule with a fill volume of 2 ml sodium chloride 9 mg/ ml (0.9%) solution (see below for various pack sizes and configurations)
Fjali 40 mg: fjali tal- ħġieġ bla kulur Tip Numru 1 (5 ml) b’ tapp laminat, issiġillat b’ għatu vjola li tiftħu b’ subgħajk (flip off) fuq kisja ta ’ l- aluminju.
3 x 3 pack: contains 3 vials with parecoxib 40 mg and 3 ampoule with 2 ml sodium chloride 9 mg/ ml (0.9%) solution.
57 Dynastat jinstab f’ pakketti ta ’ 10 fjali.
Aseptic technique is required for its preparation.
Irrikostitwixxi Dynastat 40 mg bi 2 ml soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) billi tuża teknika asettika.
Reconstitution solvents Reconstitute Dynastat 40 mg with 2 ml sodium chloride 9 mg/ ml (0.9%) solution The only other acceptable solvents for reconstitution are: 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
Glucose 50 g / l (5%) soluzzjoni għall- infużjoni sodium chloride 4. 5 mg/ ml (0. 45%) u Glucose 50 g / l (5%) soluzzjoni għall- injezzjoni.
Remove the purple flip-off cap to expose the central portion of the rubber stopper of the 40 mg parecoxib vial.
Neħħi l- kappa safra li jinfetaħ b’ subgħajk b’ mod li tesponi l- parti ċentrali tat- tapp tal- gomma tal- fjala 40 mg tal- parecoxib.
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 40 mg vial.
Iġbed permezz ta ’ labra sterili u siringa, 2ml ta ’ solvent xieraq u daħħal il- labra ġol- parti ċentrali tat- tapp tal- gomma, b’ mod li s- solvent jiġi trasferit ġol- fjala ta ’ 40 mg.
Dynastat should be administered within 24 hours of reconstitution (See Section 6.3), or discarded.
Is- soluzzjoni m’ għandiex tiġi wżata jekk tkun tilfet il- kulur jew imqallba jew jekk wieħed jinnota xi frak.
55 ANNEX II
59 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
56 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA ATTIVA U DETENTUR TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
Whalton Road Morpeth Northumberland NE61 3YA United Kingdom
Whalton Road Morpeth Northumberland NE61 3YA Ir- Renju Unit
Pfizer Manufacturing Belgium NV Rijksweg 12 2870 Puurs Belgium
Pfizer Manufacturing Belgium NV Rijksweg 12 2870 Puurs Belġjum
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Fuq il- fuljett ta 'tagħrif tal- prodott mediċinali għandu jkun hemm l- isem u l- indirizz tal- manifattur responsabbli mill- ħruġ tal- lott konċernat.
The MAH will continue to submit yearly PSURs unless otherwise specified by the CHMP
Id- detentur ta ’ L- awtorizzazzjoni għat- tqegħid fis- suq għandu jibgħat PSURs kull sena, sakem ma jkunx speċifikat mod ieħor mis- CHMP.
57 ANNEX III
61 ANNESS III
59 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
63 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON:
KARTUNA TA ’ BARRA:
20 mg PACK SIZE:
20 mg DAQS TAL- PAKKETT:
10 vials
10 FJALI
Dynastat 20 mg Powder for solution for injection
Dynastat 20 mg Trab għal soluzzjoni għall- injezzjoni
Parecoxib (as parecoxib sodium)
Parecoxib (bħala parecoxib sodium)
Each vial contains 20 mg parecoxib, as 21.18 mg parecoxib sodium.
Kull fjala fiha 20 mg parecoxib, bħala 21. 18 mg parecoxib sodium.
When reconstituted with 1 ml solvent, provides 20 mg/ ml of parecoxib.
Meta tkun rikostitwita b ’ 1 ml solvent, ikollha 20 mg/ ml ta ’ parecoxib.
Also contains disodium hydrogen phosphate, phosphoric acid and sodium hydroxide.
Ingredjenti oħra: dibasic sodium phosphate heptahydrate, phosphoric acid u sodium hydroxide.
Powder for solution for injection
Trab għalsoluzzjoni għall- injezzjoni
10 vials
10 fjali
Intravenous or intramuscular use.
Użu għal ġol- vini jew ġol- muskoli.
This medicinal product does not require any special storing conditions prior to reconstitution
Dan il- prodott mediċinali ma jeħtieġ ebda kundizzjonijiet ta ’ ħażna speċjali qabel ir- rikostituzzjoni.
60 10.
64 10.
< Batch > /< Lot > {number}
< Lott > [numru]
After reconstitution the product should be used immediately.
Wara r- rikostituzzjoni l- prodott għandu jiġi wżat minnufih.
61 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
65 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL TEXT:
KITBA FUQ IL- FJALA:
< EXP {MM/YYYY} >
JIS {XX/ SSSS}
< Batch > /< Lot > < BN >
< Lott > {numru}
62 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
66 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
1 vial AND 1 solvent ampoule
1 fjala U 1 ampulla solvent
Dynastat 20 mg Powder and solvent for solution for injection
Dynastat 20 mg Trab u solvent għal soluzzjoni għall- injezzjoni
When reconstituted with 1 ml solvent, provides 20 mg/ ml of parecoxib.
Meta tkun rikostitwita b ’ 1 ml solvent, tagħti 20 mg/ ml ta ’ parecoxib.
Also contains disodium hydrogen phosphate, phosphoric acid and sodium hydroxide.
Ingredjenti oħra: dibasic sodium phosphate heptahydrate, phsophoric acid u sodium hyroxide.
1 ml solvent ampoule contains sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.
Ampulla solvent ta ’ 1 ml fiha sodium chloride, hydrochloric acid, sodium hydroxide u ilma għal - injezzjonijiet.
Powder and solvent for solution for injection
Trab u solvent għal soluzzjoni għall- injezzjoni
1 vial and 1 solvent ampoule
1 fjala u 1 ampulla solvent
Intravenous or intramuscular use.
Għal użu fil- vina jew fil- muskoli.
This medicinal product does not require any special storing conditions prior to reconstitution..
Dan il- prodott mediċinali ma jeħtieġ ebda kundizzjoni speċjali ta ’ ħażna qabel ir- rikostituzzjoni.
After reconstitution the product should be used immediately.
Wara ir- rikostituzzjoni, il- prodott għandu jintuża minnufih.
The solution is for single use only and must not be stored in a refrigerator or freezer.
Is- soluzzjoni hija għal użu ta ’ darba biss u ma għandhiex tinħażen fi friġġ jew friża.
EU/ 1/ 02/ 209/ 002
EU/ 1/ 02/ 209/ 02
MANUFACTURER’ S BATCH NUMBER
NUMRU TAL- LOTT TAL- MANIFATTUR
After reconstitution the product should be used immediately.
Wara rikostituzzjoni l- prodott għandu jiġi wżat minnufih.
Dynastat 20mg
Dynastat 20mg
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE PACKAGING
68 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA JEW, FIN- NUQQAS TA 'DAN, FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT:
KARTUNA TA ’ BARRA:
3 vials and 3 solvent ampoules
3 fjali u 3 ampulli solvent
Also contains disodium hydrogen phosphate heptahydrate, phosphoric acid and sodium hydroxide.
Ingredjenti oħra: dibasic sodium phosphate heptahydrate, phosphoric acid u sodium hydroxide.
1 ml solvent ampoule contains sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.
Ampulla solvent ta ’ 1 ml fiha sodium chloride, hydrochloric acid, sodium hydroxide u ilma għall - injezzjonijiet.
Intravenous or intramuscular use
Użu għal ġol- vini u ġol- muskoli.
EU/ 1/ 02/ 209/ 003
EU/ 1/ 02/ 209/ 03
< Batch > < Lot > {number}
< Lott > [numru]
GENERAL CLASSIFICATION FOR SUPPLY
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATAL -
INFORMATION IN BRAILLE
INFORMATION BIL- BRAILLE
66 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
70 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
5 vials and 5 solvent ampoules
5 fjali u 5 ampulli solvent
Also contains disodium hydrogen phosphate, phosphoric acid and sodium hydroxide.
Ingredjenti oħra: dibasic sodium phosphate heptahydrate,, phosphoric acid u sodium hydroxide.
1 ml solvent ampoule contains sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.
Ampulla solvent ta ’ 1 ml fiha sodium chloride, hydrochloric acid, sodium hyrdroxide u ilma għall - injezzjonijiet.
EU/ 1/ 02/ 209/ 004
EU/ 1/ 02/ 209/ 04
INFORMATION IN BRAILLE Dynastat 20mg
INFORMAZZJONI BIL- BRAILLE
68 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
72 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
SOLVENT AMPOULE TEXT:
KITBA TA ’ AMPULLA SOLVENT:
Sodium chloride 9 mg/ ml (0.9%) solution
Sodium chloride 9 mg/ ml (0. 9%) soluzzjoni
Solvent for Dynastat 20 mg
Solvent għal Dynastat 20 mg
< EXP {MM/YYYY} >
< JIS [XX/ SSSS] >
69 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
73 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
40 mg PACK SIZE:
40 mg DAQS TAL- PAKKETT:
Dynastat 40 mg Powder for solution for injection
Dynastat 40 mg Trab għal soluzzjoni għall- injezzjoni
Each vial contains 40 mg parecoxib, as 42.36 mg parecoxib sodium.
Kull fjala fiha 40 mg parecoxib, bħala 42. 36 mg parecoxib sodium.
When reconstituted with 2 ml solvent, provides 20 mg/ ml of parecoxib.
Meta tkun rikostitwita b ’ 2 ml solvent, tagħti 20 mg/ ml ta ’ parecoxib.
Powder for solution for injection
Trab għal soluzzjoni għall- injezzjoni
This medicinal product does not require any special storing conditions prior to reconstitution.
Dan il- prodott mediċinali ma jeħtieġ ebda kundizzjoni speċjali ta ’ ħażna qabel ir- rikostituzzjoni.
EU/ 1/ 02/ 209/ 005
EU/ 1/ 02/ 209/ 05
Dynastat 40mg
Dynastat 40mg
71 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
75 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
72 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
76 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
Dynastat 40 mg Powder and solvent for solution for injection
Dynastat 40 mg Trab u solvent għal soluzzjoni għall- injezzjoni
2 ml solvent ampoule contains sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.
Ampulla solvent ta ’ 2 mlfiha sodium chloride, hydrochloric acid, sodium hydrochloride u ilma għall - injezzjonijiet
This medicinal product does not require any special storing conditions prior to reconstitution..
M ’ hemm l’ ebda istruzzjonijiet speċjali għal ħażna.
EU/ 1/ 02/ 209/ 006
EU/ 1/ 02/ 209/ 06
74 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
78 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
3 vials and 3 solvent ampoules
3 fjali u 3 ampulli sovent
2 ml solvent ampoule contains sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.
Ampulla sovent ta ’ 2ml fiha sodium chloride, hydrochloric acid, sodium hydroxide u ilma għall - injezzjonijiet.
EU/ 1/ 02/ 209/ 007
EU/ 1/ 02/ 209/ 07
76 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
80 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
2 ml solvent ampoule contains sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.
Ampulla solvent ta ’ 2 ml fiha sodium chloride, hydrochloric acid, sodium hydroxide u ilma għall - injezzjonijiet.
Intravenous or intramuscular use
Użu għal ġol- vini jew ġol- muskoli
EU/ 1/ 02/ 209/ 008
EU/ 1/ 02/ 209/ 08
78 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
82 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Sodium chloride 9 mg/ ml (0.9%) solution
Sodium chloride 9 mg/ ml (0. 9%) soluzzjoni.
Solvent for Dynastat 40 mg
Solvent għal Dynastat 40 mg
79 B.
83 B.
Information for the User
84 FULJETT TA ’ TAGĦRIF:
Dynastat 20 mg powder for solution for injection parecoxib (as parecoxib sodium)
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Dynastat 20 mg trab għal soluzzjoni għall- injezzjoni parecoxib (bħala parecoxib sodium)
Read all of this leaflet carefully before you start using this medicine.
Aqra sew dan il- fuljett kollu qabel ma tibda tieħu din il- mediċina
What Dynastat is and what it's used for 2.
X’ inhu Dynastat u għalxiex jintuża 2.
Before you use Dynastat 3.
Qabel ma tuża Dynastat 3.
How to use Dynastat 4.
Kif għandek tuża Dynastat 4.
How to store Dynastat 6.
Kif taħżen Dynastat 6.
WHAT DYNASTAT IS AND WHAT IT IS USED FOR
X’ INHU DYNASTAT U GĦALXIEX JINTUŻA
Dynastat is a powder for solution for injection.
Dynastat huwa trab għal soluzzjoni għall- injezzjoni.
It is supplied in cartons containing 10 glass vials.
Dynastat jinstab f’ pakketti ta ’ 10 fjali.
Dynastat is used to treat pain.
Dynastat jintuża biex jikkura l- uġigħ.
The injection is given to you by a doctor or nurse, usually in a hospital or clinic, such as after an operation.
It- titqiba tingħatalek min tabib/ a jew nurse ġeneralment fi sptar jew klinika, bħal wara operazzjoni.
It is one of a family of medicines called COX-2 inhibitors (this is short for cyclo-oxygenase-2 inhibitors).
Huwa wieħed minn familja ta ’ mediċini li jissejħu inibituri COX- 2 (titlu fil- qosor għal cyclo- oxygenase- 2 inhibitors)
Pain and swelling are sometimes caused by substances in the body called prostaglandins.
Sustanzi fil- ġisem msejħa prostaglandins, jistgħu jikkawżaw uġigħ u nefħa.
Dynastat works by lowering the amount of these prostaglandins.
Dynastat jaġixxi billi jnaqqas l- ammont ta ’ dawn il- prostaglandins.
There are other prostaglandins that protect the stomach lining or cause the blood to clot, and Dynastat does not affect those.
Dynastat ma jaffetwax prostaglandins oħra li jipproteġu l- kisja ta ’ ġewwa ta ’ l- istonku, jew jikkawża koagulazzjoni tad- demm.
BEFORE YOU USE DYNASTAT
Qabel ma tuża Dynastat
Do not use Dynastat
Tużax Dynastat
- if you are allergic (hypersensitive) to parecoxib or any of the other ingredients of Dynastat
- jekk inti allerġiku (tbati minn sensittività eċċessiva) għal parecoxib jew sustanzi oħra ta ’ Dynastat
- if you have had a serious allergic reaction (especially a serious skin reaction) to any medicines
- jekk kellek reazzjoni allerġika serja (b’ mod speċjali reazzjoni serja fil- ġilda) għal xi mediċini
- if you have had an allergic reaction to a group of medicines called “ sulphonamides” (e. g. some
- jekk għandek reazzjoni allerġika lejn grupp ta ’ mediċini msejjħa sulfonamidi (ez. xi antibijotiċi
antibiotics used to treat infections)
wżati kontra l- infezzjonijiet)
- if you currently have a gastric or intestinal ulcer or gastrointestinal bleeding
- jekk fil- preżent għandek ulċera gastrika jew intestinali jew fsada gastrointestinali
- if you have had an allergic reaction to acetylsalicylic acid (aspirin) or to other NSAIDs (e. g.
- jekk kellek reazzjoni allerġika għal acetylsalicylic acid (aspirina) jew NSAIDs oħrajn (ez.
ibuprofen) or to COX-2 inhibitors.
ibuprofen) jew inibituri COX- 2.
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
Reazzjonijiet jistgħu jinkludu tħarħir (bronkospażmu), imnieħrek miżdud ħafna, ħakk tal- ġilda, ħmura jew tinfiħ tal- wiċċ, xuftejn jew ilsien, reazzjonijiet allerġiċi oħra jew polipi nażali wara li tieħu dawn il- mediċini.
- if you are more than 6 months pregnant
- jekk għandek ’ l fuq minn 6 xhur tqala
- if you are breastfeeding
- jekk qegħda tredda ’
- if you have severe liver disease
- jekk għandek indeboliment sever tal- fwied
- if you have inflammation of the intestines (ulcerative colitis or Crohn’ s disease)
- jekk għandek infjammazzjoni ta ’ l- imsaren (kolite ulċerativa jew il- Marda ta ’ Crohn’ s).
- if you have heart failure
- jekk għandek insuffiċjenza serja tal- qalb
- if you are about to have heart surgery or surgery on your arteries (including any coronary artery
- jekk se tagħmel xi kirurġija f’ qalbek jew kirurġija fl- arterji tiegħek (inkluż kwalunkwe proċedura
procedure)
fl- arterja koronarja)
- if you have established heart disease and / or cerebrovascular disease e. g. if you have had a heart
- jekk għandek mard tal- qalb stabbilit u/ jew mard ċerebrovaskulari eż. jekk kellek attakk tal- qalb,
attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages
puplesija, puplesija ħafifa (TIA) jew imblukkar tal- vini għall- qalb jew għall- moħħ jew operazzjoni sabiex tiftaħ jew tagħmel bypass ta ’ vini mblukkati
81
- jekk fil- passat kellek xi ulċera, tisfija tad- demm jew perforazzjoni tal- passaġġ gastro- intestinali
- if you have or have had problems with your blood circulation (peripheral arterial disease) or if
- Tużax Dynastat jekk fil- preżent għandek xi ulċera gastrika jew intestinali jew fsada
you have had surgery on the arteries of your legs.
- jekk qed tieħu acetylsalicylic acid jew NSAIDs oħra (e. ż. ibuprofen)
If any of these applies to you, you will not be given the injection.
- jekk tbati minn anġina, emboli, pressjoni għolja jew livell għoli ta ’ kolesterol
Tell your doctor or nurse immediately.
- jekk qed tieħu xi mediċina kontra l- plejtlets (e. ż. acetylsalicylic acid)
Take special care with Dynastat
- jekk int għandek żamma ta ’ fluwidi (edema)
Make sure your doctor knows, before you are given Dynastat If you have previously had an ulcer, bleeding or perforation of the gastrointestinal tract.
Tużax Dynastat jekk għandek mard serju fil- fwied.
Do not use Dynastat if you have severe liver disease.
- jekk inti nieqes mill- ilma – dan jista jiġri jekk kellek dijarrea, kont qed tirremetti (peress li marid)
If you might be 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) If you are a woman trying to become pregnant
Jekk qed tieħu mediċini biex tnaqqas it- tgħaqqid tad- demm (e. ż. warfarina)
Taking other medicines Tell your doctor or nurse about any other medicines you are taking or took recently (in the last week) – even medicines you bought yourself without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lin- ners tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar (matul din l- aħħar ġimgħa) xi mediċini oħra, anki dawk mingħajr riċetta.
Medicines can sometimes interfere with each other.
Xi kultant, il- mediċini jistgħu jinterferixxu ma ’ xulxin.
Your doctor may reduce the dose of Dynastat or other medicines, or you may need to take a different medicine.
It- tabib tiegħek jista ’ jnaqqas id- doża ta ’ Dynastat jew ta ’ mediċini oħra, jew jista ’ jkollok bżonn tieħu mediċina differenti.
It ’ s especially important to mention:
Huwa importanti ferm għalik li ssemmi:
Acetylsalicylic acid or other anti-inflammatory drugs Fluconazole – used for fungal infections ACE inhibitors – used for high blood pressure and heart conditions Cyclosporin or Tacrolimus – used after transplants Warfarin – or other medicines used to prevent blood clots Lithium – used to treat depression Rifampicin – used for bacterial infections Antiarrhythmics – used to treat an irregular heartbeat Phenytoin or Carbamazepine – used for epilepsy Theophylline – used for asthma Methotrexate – used for rheumatoid arthritis and cancer Antidepressants – used to treat depression Neuroleptics – used to treat psychoses
Acetylsalicylic acid jew mediċini oħra kontra l- infjammazzjoni Fluconazole – użati biex jittrataw infezzjonijiet tal- fungi Inibituri ta ’ l- ACE – użati għal pressjoni għolja u mard tal- qalb Cyclosporin jew Tacrolimus – użati wara trapjanti Warfarin – jew mediċini oħra użati biex jimpedixxu emboli Lithium – użat kontra d- depressjoni Rifampicin – użat għal infezzjonjiet ikkawżati minn batterji Mediċini kontra l- arritmja – użati sabiex jittratta taħbit irregolari tal- qalb Phenytoin jew Carbamazepine – użat għall- epilessija Theophylline – użat għall- ażma Methotrexate – għal l- artrite rewmatika u kanċer Anti- depressanti – użati biex jittrattaw id- depressjoni Newrolettiċi – użati sabiex jittrattaw psikożi
Dynastat can be used in combination with low dose acetylsalicylic acid
Dynastat jista ’ jintuża flimkien ma ’ doża baxxa ta ’ acetylsalicylic acid
Pregnancy and breast-feeding If you are pregnant, tell your doctor, as Dynastat may not be right for you.
- Jekk int tqila, għid lit- tabib tiegħek, għax Dynastat jista ’ ma jkunx tajjeb għalik.
You will not be given Dynastat in the last three months of pregnancy.
M’ intix ser tingħata Dynastat fl- aħħar tlett xhur tat- tqala.
If you are breast-feeding, you must not have Dynastat.
- Jekk qed tredda ’, m’ għandekx tieħu Dynastat.
Ask your doctor for advice: it may be better to stop breast-feeding altogether to take the injections.
li tieqaf tredda ’ minnufih biex tieħu l- injezzjonijiet.
Get advice from a doctor or pharmacist before taking any medicine if you ’ re pregnant or breast- feeding.
Itlob għall- parir tat- tabib jew l- ispiżjar tiegħek qabel tieħu xi mediċina jekk int tqila jew qed tredda ’.
82 Driving and using machines If the injection makes you feel dizzy or tired, do not drive or use machines until you feel better again.
Sewqan u tħaddim ta ’ magni Jekk l- injezzjoni tistordik jew tħeddlek, issuqx u m’ għandekx tħaddem magni sa ma tħossok aħjar.
HOW TO USE DYNASTAT
KIF TINGĦATA L- INJEZZJONI
Dynastat will be given to you by a doctor or nurse.
Dynastat jingħatalek minn tabib jew infermier/ a.
They will dissolve the powder before giving you the injection, and will inject the solution into a vein or a muscle.
Huma se jħollu t- trab qabel jagħtuk l- injezzjoni, u jinjettaw is- soluzzjoni ġol- vina jew ġol- muskolu.
You will only be given Dynastat for short periods, and only for pain relief.
Int tingħata Dynastat biss għal perjodu qasir ta ’ żmien u biex itaffilek l- uġigħ biss.
If there are particles in the injection solution or if either the powder or solution is discoloured, the product will not be used.
Jekk hemm xi frak fis- soluzzjoni ta ’ l- injezzjoni, jew jekk it- trab jew is- soluzzjoni tilfet il- kulur, il - prodott m’ għandux jintuża.
The usual dose to start with is 40 mg.
Id- doża li normalment tibda biha hi ta ’ 40 mg.
You may be given another dose – either 20 mg or 40 mg – 6 to 12 hours after the first one.
Int tista ’ tingħata doża oħra - jew ta ’ 20 mg jew ta ’ 40 mg - minn 6 sa 12 - il siegħa wara li tkun ingħatajt l- ewwel waħda.
You will not be given more than 80 mg in 24 hours.
Mhux se jingħatalek aktar minn 80 mg fi żmien 24 siegħa.
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.
Xi persuni jistgħu jingħataw dożi iżgħar Persuni bi problemi fil- fwied Persuni bi problemi serji fil- kliewi Persuni li għandhom ‘ l fuq minn 65 sena u li jiżnu inqas minn 50 kg Persuni li jkunu qegħdin jieħdu fluconazole