natgillin/translations-raw huggingface dataset:
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).
Dynastat je na voljo v obliki sterilne viale za enkratno uporabo, skupaj z 2- ml ampulo s polnitveno prostornino 1 ml raztopine natrijevega klorida 9 mg/ ml (0, 9%) (glejte spodaj za različna pakiranja).
Pack sizes 1 x 1 pack: contains 1 vial with parecoxib 20 mg and 1 ampoule with 1 ml sodium chloride 9 mg/ ml (0.9%) solution.
Velikosti pakiranj Pakiranje 1 x 1: vsebuje 1 vialo z 20 mg parekoksiba in 1 ampulo z 1 ml raztopine natrijevega klorida 9 mg/ ml (0, 9%).
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.
Pakiranje 3 x 3: vsebuje 3 viale z 20 mg parekoksiba in 3 ampule z 1 ml raztopine natrijevega klorida 9 mg/ ml (0, 9%).
5 x 5 pack: contains 5 vials of parecoxib 20 mg and 5 ampoule with 1 ml sodium chloride 9 mg/ ml (0.9%) solution.
Pakiranje 5 x 5: vsebuje 5 vial z 20 mg parekoksiba in 5 ampul z 1 ml raztopine natrijevega klorida 9 mg/ ml (0, 9%).
26 6.6 Special precautions for disposal and other handling
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Reconstitution solvents Reconstitute Dynastat 20 mg with 1 ml sodium chloride 9 mg/ ml (0.9%) solution.
26 Vehikli za pripravo Za pripravo raztopine 20 mg Dynastata z 1 ml raztopine natrijevega klorida 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
5% (50 g/ l) raztopina glukoze za infundiranje raztopina 0, 45% (4, 5 mg/ ml) natrijevega klorida in 5% (50 g/ l) glukoze za injiciranje.
After reconstitution, Dynastat should be inspected visually for particulate matter and discoloration prior to administration.
Po pripravi je treba Dynastat pregledati in se tako prepričati, da ne vsebuje delcev in ni obaravan.
Dynastat should be administered within 24 hours of reconstitution (see section 6.3), or discarded
Dyanstat je treba aplicirati v 24 urah po pripravi (glejte poglavje 6. 3) ali pa ga zavreči.
IV line solution compatibility After reconstitution with acceptable solvents, Dynastat may only be injected IV or IM, or into IV lines delivering:
Kompatibilnost z raztopinami v intravenski liniji Po pripravi z dovoljenim vehiklom smemo Dynastat injicirati samo intravensko ali intramuskularno, ali v intravensko pot, po kateri teče:
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
Each vial contains 40 mg parecoxib (present as 42.36 mg parecoxib sodium) for reconstitution.
Vsaka 40- mg viala vsebuje 40 mg parekoksiba v obliki natrijeve soli (42, 36 mg natrijevega parekoksibata) za pripravo raztopine.
When reconstituted in sodium chloride 9 mg/ ml (0.9%) solution, Dynastat contains approximately 0.44 mEq of sodium per vial.
Po pripravi z 9 mg/ ml (0, 9%) raztopino natrijevega klorida vsebuje Dynastat približno 0, 44 mEq natrija na vialo.
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
29 5% (50 g/ l) raztopina glukoze za infundiranje raztopina 0, 45% (4, 5 mg/ ml) natrijevega klorida in 5% (50 g/ l) glukoze za injiciranje raztopina Ringerjevega laktata za injiciranje
Therefore, its use is not recommended in these patients.
Uporaba tega zdravila pri teh bolnikih torej ni priporočljiva.
History of previous serious allergic drug reaction of any type, especially cutaneous reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme or patients with known hypersensitivity to sulphonamides (see sections 4.4 and 4.8).
Stevens - Johnsonovega sindroma, toksične epidermalne nekrolize, multiformnega eritema ali bolniki z znano preobčutljivostjo za sulfonamide (glejte poglavji 4. 4. in 4. 8).
Active peptic ulceration or (GI) gastrointestinal bleeding.
Zdravilo je kontraindicirano:
Treatment of post-operative pain following coronary artery bypass graft (CABG) surgery (see section 4.8 and 5.1).
- zdravljenje pooperacijske bolečine CABG (operativna vstavitev presadka koronarnega obvoda)
There is limited clinical experience with Dynastat treatment beyond three days.
Kliničnih izkušenj z več kot dvodnevno uporabo Dynastata je malo.
Studies in other surgeries than CABG procedures included patients with ASA (American Society of Anaesthesiology) Physical Status Class I-III only.
Študije drugih operacijskih posegov, razen postopke CABG, so vključevale le bolnike s kliničnim statusom ASA (ASA - American Society of Anaesthesiology), razreda I- III.
There is further increase in the risk of gastrointestinal adverse effects (gastrointestinal ulceration or other gastrointestinal complications), when parecoxib sodium is taken concomitantly with acetylsalicylic acid (even at low doses).
Tveganje za neželene učinke v prebavilih (razjeda v prebavilih in drugi gastrointestinalni zapleti), se še dodatno poveča, kadar se parekoksib uporablja sočasno z acetilsalicilno kislino (celo pri majhnih odmerkih).
However, the reported rate of serious skin events
Znano je, da se med uporabo nesteroidnih protivnetnih zdravil,
31 appears to be greater for valdecoxib (the active metabolite of parecoxib) as compared to other COX-2 selective inhibitors.
31 vključno s selektivnimi zaviralci COX- 2, in tudi drugih zdravil pojavljajo resne kožne reakcije.
Acute renal failure has been reported through post-marketing surveillance in patients receiving parecoxib (see section 4.8).
Med raziskavami po pridobitvi dovoljenja za promet so pri bolnikih, ki so prejemali parekoksib, poročali o akutni odpovedi ledvic (glejte pogalvje 4. 8).
Co-administration of parecoxib sodium and heparin did not affect the pharmacodynamics of heparin (activated partial thromboplastin time) compared to heparin alone.
32 Sočasna uporaba natrijevega parekoksibata in heparina ni vplivala na farmakodinamiko heparina (aktivirani delni tromboplastinski čas) v primerjavi z dajanjem samega heparina.
32 NSAIDs may reduce the effect of diuretics and antihypertensive medicinal products.
Nesteroidna protivnetna zdravila lahko zmanjšajo učinek diuretikov in antihipertenzivnih zdravil.
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.
33 Anestetiki za injiciranje:
Parecoxib sodium is suspected to cause serious birth defects when administered during the last trimester of pregnancy because as with other medicinal products known to inhibit prostaglandin synthesis, it may cause premature closure of the ductus arteriosus oruterine inertia (see sections 4.3, 5.1 and 5.3).
Dynastat je kontraindiciran v zadnjem trimesečju nosečnosti (glejte poglavje 4. 3).
34 discontinuation rate due to adverse events in these studies was 5.0% for patients receiving Dynastat and 4.3% for patients receiving placebo.
Delež prekinitev zaradi neželenih učinkov je bil v teh raziskavah 5, 0% pri bolnikih, ki so dobivali Dynastat, in 4, 3% pri tistih, ki so dobivali placebo.
[Very Common (≥ 1/ 10), Common (≥ 1/ 100, < 1/ 10) Uncommon (≥ 1/ 1000, < 1/ 100) Rare (≥ 1/ 10,000, < 1/ 1000) Very rare (< 1/ 10,000), not known (cannot be estimated from the available data)]
[Zelo pogosto (≥ 1/ 10), pogosto (≥ 1/ 100, < 1/ 10), občasno (≥ 1/ 1. 000, < 1/ 100), redko (≥ 1/ 10. 000, < 1/ 1. 000), zelo redko (< 1/ 10. 000), ni znano (ni mogoče oceniti iz podatkov, ki so na voljo)]
Infections and infestations Uncommon: abnormal sternal serous wound drainage, wound infection.
34 Infekcijske in parazitske bolezni Občasno: nenormalen serozen izcedek iz sternalne rane, okužba rane
SGOT increased, SGPT increased, blood urea nitrogen increased
Preiskave Pogosto: zvišanje kreatinina v krvi Občasno: zvišanje SGOT, zvišanje SGPT, zvišanje sečnine
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.
Naslednji redki, resni neželeni učinki so bili opisani med uporabo nesteroidnih protivnetnih zdravil in jih pri Dynastatu ni mogoče izključiti: bronhospazem in hepatitis.
Following coronary artery bypass graft surgery, patients administered Dynastat have a higher risk of adverse events, such as cardiovascular/ thromboembolic events, deep surgical infections and sternal wound healing complications.
Po obvodni operaciji koronarnih arterij bolnike, ki dobijo Dynastat, bolj ogrožajo neželeni učinki, npr. kardiovaskularni/ tromboembolični dogodki, globoke kirurške okužbe in zapleti na sternalni rani.
Rare: acute renal failure, renal failure, myocardial infarction, congestive heart failure, abdominal pain, nausea, vomiting, dyspnoea, tachycardia and Stevens-Johnson syndrome.
35 Redko: akutna odpoved ledvic, odpoved ledvic, miokardni infarkt, kongestivno srčno popuščanje, abdominalna bolečina, navzea, bruhanje, dispneja, tahikardija in Stevens- Johnsonov sindrom.
36 Opioid-sparing Effects:
Učinek manjše uporabe opioidov:
The reduction in opioid use with Dynastat treatment on Days 2 and 3 was 7.2 mg and 2.8 mg (37% and 28% respectively). This reduction in opioid use was accompanied by significant reductions in patient-reported opioid symptom distress.
28%).
There are no data indicating less overall adverse events associated with the use of parecoxib compared to placebo when used in conjunction with opioids.
36 parekoksiba v primerjavi s placebom niso zasledili podatkov, ki bi ob sočasnem jemanju opioidov nakazovali povezavo z manjšo prisotnostjo celotnih neželenih učinkov.
Three of the six cardiovascular thromboembolic events in the placebo/ valdecoxib treatment group occurred during the placebo treatment period; these patients did not receive valdecoxib.
Vnaprej določeni dogodki, ki so se najpogosteje pojavljali v vseh treh obravnavanih skupinah, so vključevali zaplete v zvezi s kirurško rano, to je globlje ležeče infekcije kirurške rane ali zdravljenje rane na prsnici.
Pre-specified events that occurred with the highest incidence in all three treatment groups involved the category of surgical wound complications, including deep surgical infections and sternal wound healing events.
Aktivne terapije se niso značilno razlikovale od placeba glede nobene vnaprej opredeljene kategorije pojavov (moteno delovanje ledvic/ ledvična odpoved, zapleti z razjedami v zgornjih prebavilih ali zapleti kirurške rane).
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).
Glede profila splošne varnosti niso pri bolnikih po prestani operaciji zaznali nobene pomembne razlike, tudi ne glede vnaprej določenih kategorij, ki so opisane zgoraj v zvezi z drugo študijo operacije CABG, v zvezi s prejemanjem parekoksiba natrija/ valdekoksiba v primerjavi s prejemanjem placeba.
37 General Surgery:
37 Raziskave trombocitov:
38 Elderly Subjects:
Starejše osebe:
Because renal elimination of valdecoxib is not important to its disposition, no changes in valdecoxib clearance were found even in patients with severe renal impairment or in patients undergoing dialysis (see section 4.2).
38 njegovo odstranjevanje, sprememb očistka valdekoksiba niso ugotovili niti pri bolnikih s hudo ledvično okvaro ali na dializi (glejte poglavje 4. 2).
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.
Priprava raztopine natrijevega parekoksibata z uporabo raztopine Ringerjevega laktata za injiciranje ali 5% (50 g/ l) glukoze v raztopini Ringerjevega laktata za injiciranje povzroči precipitacijo parekoksiba iz raztopine in zato ni priporočljiva.
Injection into an IV line delivering glucose 50 g/ l (5%) in Ringer-Lactate solution for injection, or other IV fluids not listed in 6.6, is not recommended as this may cause precipitation from solution.
39 Injiciranje v intravensko pot, po kateri teče 5% (50 g/ l) glukoza v raztopini Ringerjevega laktata ali kakšna druga intravenska tekočina, ki ni navedena v poglavju 6. 6, ni priporočljivo, ker lahko povzroči precipitacijo natrijevega parekoksiba iz raztopine.
This medicinal nproduct does not require special storing conditions prior to reconstitution.
Za shranjevanje zdravila pred pripravo niso potrebna posebna navodila.
Parecoxib sodium vials 40 mg vials:
Viale z natrijevim parekoksibatom 40- mg viale:
Type I colourless glass vials (5 ml) with a laminated stopper, sealed with a purple flip- off cap on the aluminium overseal.
5- ml steklene viale iz brezbarvnega stekla tipa I z laminiranim zamaškom, zaščitenim s prevleko iz aluminija, ki ima na sredini vijolčno pretržno zaporko, ki se odstrani na poteg.
Reconstitution Process Use aseptic technique to reconstitute lyophilised parecoxib (as parecoxib sodium).
Postopek priprave Za pripravo liofiliziranega parekoksiba (v obliki natrijevega parekoksibata) uporabite aseptični postopek.
Remove the purple flip-off cap to expose the central portion of the rubber stopper of the 40 mg parecoxib vial.
Odstranite vijolčno pretržno zaporko, da boste razkrili osrednji del gumijastega zamaška viale s 40 mg parekoksiba.
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.
S sterilno iglo in brizgo izvlecite 2 ml dovoljenega vehikla; zabodite iglo skozi osrednji del gumijastega zamaška in prenesite vehikel v 40- mg vialo.
40 After reconstitution, Dynastat should be inspected visually for particulate matter and discoloration prior to administration.
Po pripravi je treba Dynastata pregledati in se tako prepričati, da ne vsebuje delcev in ni obarvan.
The solution should not be used if discolored or cloudy, or if particulate matter is observed.
Če je raztopina obarvana, motna ali so v njen delci, je ne smete uporabiti.
IV line solution compatibility After reconstitution with acceptable solvents, Dynastat may only be injected IV or IM, or into IV lines delivering:
40 Kompatibilnost z raztopinami v intravenski liniji Po pripravi z dovoljenim vehiklom smemo Dynastat injicirati samo intravensko ali intramuskularno, ali v intravensko pot, po kateri teče:
Solvent: clear and colourless solution.
Vehikel: bistra, brezbarvna raztopina
In all clinical assessments parecoxib was administered at a fixed time interval whereas the opioids were administered on as needs basis (PRN).
V vseh kliničnih ocenjevanjih so parekoksib uporabljali v določenih časovnih presledkih, opioide pa po potrebi (PP).
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
0, 9% (9 mg/ ml) raztopina natrijevega klorida 5% (50 g/ l) raztopina glukoze za infundiranje raztopina 0, 45% (4, 5 mg/ ml) natrijevega klorida in 5% (50 g/ l) glukoze za injiciranje raztopina Ringerjevega laktata za injiciranje
43 Established ischaemic heart disease, peripheral arterial disease and/ or cerebrovascular disease.
43
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).
Tveganje za neželene učinke v prebavilih (razjeda v prebavilih ali drugi gastrointestinalni zapleti), se še dodatno poveča, kadar se parekoksib uporablja sočasno z acetilsalicilno kislino (celo pri majhnih odmerkih).
44 Parecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
44 Parekoksib moramo ukiniti ob prvem pojavu kožnega izpuščaja, lezij na sluznicah ali kakršnegakoli drugega znaka preobčutljivosti.
However, the reported rate of serious skin events appears to be greater for valdecoxib (the active metabolite of parecoxib) as compared to other COX-2 selective inhibitors.
Toda, kot kaže, je opisani delež resnih kožnih reakcij je večji pri valdekoksibu (aktivnemu presnovku parekoksiba) kot pri drugih selektivnih zaviralcih COX- 2.
45 Co-administration of parecoxib sodium and heparin did not affect the pharmacodynamics of heparin (activated partial thromboplastin time) compared to heparin alone.
45 Sočasna uporaba natrijevega parekoksibata in heparina ni vplivala na farmakodinamiko heparina (aktivirani delni tromboplastinski čas) v primerjavi z dajanjem samega heparina.
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.
46 Anestetiki za injiciranje:
Within each frequency grouping, undesirable effect are presented in order of decreasing seriousness.
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
47 discontinuation rate due to adverse events in these studies was 5.0% for patients receiving Dynastat and 4.3% for patients receiving placebo.
Delež prekinitev zaradi neželenih učinkov je bil v teh raziskavah 5, 0% pri bolnikih, ki so dobivali Dynastat, in 4, 3% pri tistih, ki so dobivali placebo.
Infections and infestations Uncommon: abnormal sternal serous wound drainage, wound infection.
47 Infekcijske in parazitske bolezni Občasno: nenormalen serozen izcedek iz sternalne rane, okužba rane
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.
Naslednji redki, resni neželeni učinki so bili opisani med uporabo nesteroidnih protivnetnih zdravil in jih pri Dynastatu ni mogoče izključiti: bronhospazem in hepatitis.
Rare: acute renal failure, renal failure, myocardial infarction, congestive heart failure, abdominal pain, nausea, vomiting, dyspnoea, tachycardia and Stevens-Johnson syndrome.
48 Redko: akutna odpoved ledvic, odpoved ledvic, miokardni infarkt, kongestivno srčno popuščanje, abdominalna bolečina, navzea, bruhanje, dispneja, tahikardija in Stevens- Johnsonov sindrom.
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).
V obdobju po pridobitvi dovoljenja za promet je bila v zvezi z uporabo valdekoksiba opisana naslednja reakcija; ki je ni mogoče izključiti tudi pri parekoksibu: toksična epidermalna nekroliza (glejte poglavje 4. 4).
49 Opioid-sparing Effects:
Učinek manjše uporabe opioidov:
There are no data indicating less overall adverse events associated with the use of parecoxib compared to placebo when used in conjunction with opioids.
49 parekoksiba v primerjavi s placebom niso zasledili podatkov, ki bi ob sočasnem jemanju opioidov nakazovali povezavo z manjšo prisotnostjo celotnih neželenih učinkov.
50 General Surgery:
50 Raziskave trombocitov:
51 Elderly Subjects:
Starejše osebe:
Because renal elimination of valdecoxib is not important to its disposition, no changes in valdecoxib clearance were found even in patients with severe renal impairment or in patients undergoing dialysis (see section 4.2).
51 njegovo odstranjevanje, sprememb očistka valdekoksiba niso ugotovili niti pri bolnikih s hudo ledvično okvaro ali na dializi (glejte poglavje 4. 2).
Use of Sterile Water for Injection is not recommended, as the resulting solution is not isotonic.
52 Uporaba vode za injekcije ni priporočljiva, ker nastala raztopina ni izotonična.
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)
Dynastat je na voljo v obliki sterilne viale za enkratno uporabo, skupaj z 2- ml ampulo s polnitveno prostornino 2 ml raztopine natrijevega klorida 9 mg/ ml (0, 9%) (glejte spodaj za različna pakiranja).
Pack Sizes 1 x 1 pack: contains 1 vial with parecoxib 40 mg and 1 ampoule with 2 ml sodium chloride 9 mg/ ml (0.9%) solution.
Velikosti pakiranj Pakiranje 1 x 1: vsebuje 1 vialo s 40 mg parekoksiba in 1 ampulo z 2 ml raztopine natrijevega klorida 9 mg/ ml (0, 9%).
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.
Pakiranje 3 x 3: vsebuje 3 viale s 40 mg parekoksiba in 3 ampule z 2 ml raztopine natrijevega klorida 9 mg/ ml (0, 9%).
53 5 x 5 pack: contains 5 vials with parecoxib 40 mg and 5 ampoule with 2 ml sodium chloride 9 mg/ ml (0.9%) solution.
Pakiranje 5 x 5: vsebuje 5 vial s 40 mg parekoksiba in 5 ampul z 2 ml raztopine natrijevega klorida 9 mg/ ml (0, 9%).
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
5% (50 g/ l) raztopina glukoze za infundiranje raztopina 0, 45% (4, 5 mg/ ml) natrijevega klorida in 5% (50 g/ l) glukoze za injiciranje.
Dynastat should be administered within 24 hours of reconstitution (See Section 6.3), or discarded.
Dynastat je treba aplicirati v 24 urah po pripravi (glejte poglavje 6. 3) ali pa ga zavreči.
55 ANNEX II
55 DODATEK II
56 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
Whalton Road Morpeth Northumberland NE61 3YA United Kingdom
Whalton Road Morpeth Northumberland NE61 3YA Velika Britanija
Pfizer Manufacturing Belgium NV Rijksweg 12 2870 Puurs Belgium
Pfizer Manufacturing Belgium NV Rijksweg 12 2870 Puurs Belgija
The MAH will continue to submit yearly PSURs unless otherwise specified by the CHMP
Imetnik dovoljenja za promet bo še naprej vlagal letna poročila PSUR, razen če CHMP ne odloči drugače.
57 ANNEX III
57 DODATEK III
59 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
59 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
OUTER CARTON:
ZUNANJA OVOJNINA:
20 mg PACK SIZE:
20 mg VELIKOST PAKIRANJA:
Dynastat 20 mg Powder for solution for injection
Dynastat 20 mg prašek za raztopino za injiciranje
Parecoxib (as parecoxib sodium)
parekoksib (v obliki natrijevega parekoksibata)
Each vial contains 20 mg parecoxib, as 21.18 mg parecoxib sodium.
Vsaka viala vsebuje 20 mg parekoksiba, v obliki 21, 18 mg natrijevega parekoksibata.
When reconstituted with 1 ml solvent, provides 20 mg/ ml of parecoxib.
Po pripravi z 1 ml vehikla nastane raztopina z 20 mg/ ml parekoksiba.
Powder for solution for injection
Prašek za raztopino za injiciranje.
Intravenous or intramuscular use.
Za intravensko ali intramuskularno uporabo.
This medicinal product does not require any special storing conditions prior to reconstitution
Za shranjevanje zdravila pred pripravo niso potrebna posebna navodila.
< Batch > /< Lot > {number}
{številka}
After reconstitution the product should be used immediately.
Po pripravi je treba zdravilo uporabiti takoj.
61 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
61 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VIAL TEXT:
BESEDILO NA VIALI:
< EXP {MM/YYYY} >
{MM/ LLLL}
< Batch > /< Lot > < BN >
< Serija: > {številka}
62 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
62 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
1 vial AND 1 solvent ampoule
1 viala IN 1 ampula z vehiklom