natgillin/translations-raw huggingface dataset:
Parecoxib 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, it may cause premature closure of the ductus arteriosus or uterine inertia (see sections 4.3, 5.1 and 5.3).
Za parekoksib se sumnja da uzrokuje ozbiljne urođene defekte kad se primjenjuje tijekom posljednjeg tromjesečja trudnoće, zato što kao i drugi lijekovi za koje se zna da inhibiraju prostaglandin, može prouzročiti preuranjeno zatvaranje ductus arteriosusa ili inerciju uterusa (vidjeti dijelove 4.3, 5.1 i 5.3).
There is limited experience in other types of surgery, for example gastrointestinal or urological surgery (see section 5.1).
Ograničeno je iskustvo s primjenom kod drugih vrsta operacija, na primjer gastrointestinalnih ili uroloških operacija (vidjeti dio 5.1).
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%).
Značajno (p=0,033) veća incidencija događaja u kardiovaskularnoj/tromboembolijskoj kategoriji otkrivena je u skupini liječenoj parekoksibom/valdekoksibom (2,0%) u usporedbi sa skupinom koja je primala placebo/placebo (0,5%).
Severe hepatic impairment (serum albumin <25 g/l or Child-Pugh score 10).
Teško oštećenje funkcije jetre (serumski albumin <25 g/l ili Child-Pugh rezultat  10).
In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of NSAIDs, including Dynastat should be considered.
U žena koje imaju problema sa začećem ili koje se podvrgavaju testiranju neplodnosti treba razmotriti prekid liječenja nesteroidnim protuupalnim lijekovima uključujući i Dynastat.
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.
U onih bolesnika u kojih se ista i.v. linija koristi za injiciranje drugog lijeka, linija se mora primjereno isprati prije i nakon injiciranja Dynastata otopinom poznate kompatibilnosti.
The mean (SD) duration of treatment was 4.1 (0.4) days for parecoxib and 4.2 (0.5) days for placebo, the range was 4-7 days for parecoxib and 4-9 days for placebo.
Srednja vrijednost (SD) trajanja liječenja parekoksibom iznosila je 4,1 (0,4) dana, a 4,2 (0,5) dana za placebo, dok je raspon bio od 4 do 7 dana za parekoksib i od 4 do 9 dana za placebo.
On the basis of pharmacokinetics, no dose adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance of 30-80 ml/min.
Na temelju farmakokinetike, nije potrebna prilagodba doziranja u bolesnika s blagim do umjerenim oštećenjem bubrega (klirens kreatinina od 30 do 80 ml/min).
Effects of other medicinal products on the pharmacokinetics of parecoxib (or its active metabolite valdecoxib)
Učinci drugih lijekova na farmakokinetiku parekoksiba (ili njegovog djelatnog metabolita valdekoksiba)
Moderate hepatic impairment did not result in a reduced rate or extent of parecoxib conversion to valdecoxib.
Umjereno oštećenje jetre nije dovelo do smanjenja brzine ili opsega konverzije parekoksiba u valdekoksib.
Reporting of overdose with parecoxib has been associated with adverse reactions which have also been described with recommended doses of parecoxib.
Zabilježena predoziranja parekoksibom povezana su s nuspojavama koje su također bile opisane i uz preporučene doze parekoksiba.
In humans, studies demonstrated that valdecoxib metabolism is predominantly mediated via CYP3A4 and 2C9 isozymes.
U ljudi, ispitivanja su pokazala da je metabolizam valdekoksiba pretežno posredovan izoenzimima CYP3A4 i 2C9.
Dynastat is preservative free.
Dynastat ne sadrži konzervanse.
Solvent: clear and colourless solution.
Otapalo: bistra i bezbojna otopina.
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.
Međutim, zabilježena stopa ozbiljnih kožnih događaja čini se većom kod primjene valdekoksiba (djelatnog metabolita parekoksiba) nego drugih selektivnih inhibitora COX-2.
Patients with a history of sulfonamide allergy may be at greater risk of skin reactions (see section 4.3).
Bolesnici koji u povijesti bolesti imaju alergiju na sulfonamide mogu biti u većem riziku od kožnih reakcija (vidjeti dio 4.3).
The most serious reactions occur uncommonly to rarely, and include cardiovascular events such as myocardial infarction and severe hypotension, as well as hypersensitivity events such as anaphylaxis, angioedema and severe skin reactions.
Najozbiljnije reakcije se javljaju manje često ili rijetko, a uključuju kardiovaskularne događaje kao što su infarkt miokarda i teška hipotenzija, kao i reakcije preosjetljivosti poput anafilaksije, angioedema i teških kožnih reakcija.
The first perceptible analgesic effect occurred in 7-13 minutes, with clinically meaningful analgesia demonstrated in 23-39 minutes and a peak effect within 2 hours following administration of single doses of 40 mg IV or IM Dynastat.
Prvi zamjetni analgetski učinak nastupio je nakon 7-13 minuta, uz klinički značajnu analgeziju nakon 2339 minuta i vršni učinak unutar 2 sata nakon primjene jednokratne doze Dynastata od 40 mg i.v. ili i.m.
The carcinogenic potential of parecoxib has not been evaluated.
Kancerogenost parekoksiba nije ispitana.
SOLVENT AMPOULE LABEL : 2 ml
NALJEPNICA AMPULE S OTAPALOM: 2 ml
No effects of parecoxib on male or female fertilities were found in rats.
U štakora nisu pronađeni nikakvi učinci parekoksiba na plodnost mužjaka ili ženki.
As with all NSAIDs, parecoxib can lead to the onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of cardiovascular events.
Kao i drugi nesteroidni protuupalni lijekovi, parekoksib može dovesti do nastanka hipertenzije ili pogoršanja postojeće hipertenzije, a oboje može pridonijeti povećanju incidencije kardiovaskularnih događaja.
There is limited clinical experience with Dynastat treatment beyond three days.
Kliničko je iskustvo u liječenju Dynastatom duljem od tri dana ograničeno.
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 je izooblik enzima za koji se pokazalo da ga induciraju proupalni podražaji i smatra se da je prvenstveno zadužen za sintezu prostanoidnih medijatora boli, upale i vrućice.
A hydroxylated metabolite of valdecoxib (via the CYP pathway) has been identified in human plasma that is active as a COX-2 inhibitor.
Hidroksilirani metabolit valdekoksiba (putem CYP-a) koji je pronađen u ljudskoj plazmi aktivan je kao inhibitor COX-2.
Dissolve the powder completely using a gentle swirling motion and inspect the reconstituted product before use.
Potpuno otopite prašak u bočici laganim kružnim pokretima i pregledajte rekonstituirani lijek prije primjene.
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).
Ne postoji kliničko iskustvo u bolesnika s teškim oštećenjem jetre (Child-Pugh rezultat 10) pa je stoga njegova primjena u ovih bolesnika kontraindicirana (vidjeti dijelove 4.3 i 5.2).
Dynastat contains
Dynastat sadrži
Caution should be exercised when coadministering Dynastat with warfarin and other oral anticoagulants (see section 4.5).
Potreban je oprez kad se Dynastat primjenjuje istodobno s varfarinom i drugim oralnim antikoagulansima (vidjeti dio 4.5).
If there is clinical evidence of deterioration in the condition of these patients, appropriate measures including discontinuation of parecoxib should be taken.
Ako postoji klinički dokaz pogoršanja stanja tih bolesnika, moraju se poduzeti odgovarajuće mjere uključujući i prekid primjene parekoksiba.
• Use of Sterile Water for Injection for reconstitution is not recommended, as the resulting solution is not isotonic.
• Primjena sterilne vode za injekciju ne preporučuje se za rekonstituciju, jer otopina koja se dobije nije 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 se isporučuje kao sterilna bočica s jediničnom dozom za jednokratnu primjenu, pakirana s ampulom od 2 ml napunjenu volumenom od 2 ml otopine natrijevog klorida 9 mg/ml (0,9%) (vidjeti niže za različite veličine pakiranja i oblike).
However caution is advised when methotrexate is administered concurrently with NSAIDs, because NSAID administration may result in increased plasma levels of methotrexate.
Međutim, preporučuje se oprez kada se metotreksat primjenjuje istodobno s nesteroidnim protuupalnim lijekovima, jer primjena nesteroidnih protuupalnih lijekova može uzrokovati povećane razine metotreksata u plazmi.
How to store Dynastat
Kako čuvati Dynastat
Dynastat may be coadministered with opioid analgesics.
Dynastat se može istodobno primjenjivati s opioidnim analgeticima.
Studies in types of surgery other than CABG procedures included patients with American Society of Anaesthesiology (ASA) Physical Status Class I-III only.
Ispitivanja primjene kod drugih vrsta operacija osim postupaka ugradnje aortokoronarne premosnice uključila su samo bolesnike s fizikalnim statusom klase I-III prema Američkom anesteziološkom društvu (engl.
Dynastat should be used with caution in patients with moderate hepatic impairment (Child-Pugh score 7-9) (see section 4.2).
Dynastat se mora primjenjivati s oprezom u bolesnika s umjerenim oštećenjem jetre (Child-Pugh rezultat 7-9) (vidjeti dio 4.2).
These decreases were not considered clinically important since Cmax of valdecoxib is comparable after IM and IV parecoxib administration.
Ta se sniženja nisu smatrala klinički važnima budući da je Cmax valdekoksiba usporediv nakon i.m. i i.v. primjene parekoksiba.
There are no data indicating less overall adverse events associated with the use of parecoxib compared to placebo when used in conjunction with opioids.
Nema podataka koji pokazuju da parekoksib, u usporedbi s placebom, ima ukupno manje štetnih događaja povezanih s njegovom primjenom kad se primjenjuje zajedno s opioidima.
Treatment with valdecoxib (40 mg twice daily for 7 days) produced a 3-fold increase in plasma concentrations of dextromethorphan (CYP2D6 substrate).
Liječenje valdekoksibom (40 mg dvaput dnevno tijekom 7 dana) izazvalo je trostruko povećanje koncentracije dekstrometorfana (supstrata CYP2D6) u plazmi.
In a series of small, multiple dose studies in healthy young and elderly subjects, Dynastat 20 mg or 40 mg twice daily had no effect on platelet aggregation or bleeding compared to placebo.
U nizu malih ispitivanja višekratne doze u zdravih mladih i starijih ispitanika, Dynastat u dozi od 20 mg ili 40 mg dvaput dnevno nije imao utjecaja na agregaciju trombocita ili krvarenje u usporedbi s placebom.
▪ If you have previously had an ulcer, bleeding or perforation of the gastrointestinal tract.
• ako ste prethodno imali čir, krvarenje ili probušenje (perforaciju) probavnog trakta
Therefore, caution should be observed when coadministering Dynastat and medicinal products that are predominantly metabolised by CYP2D6 and which have narrow therapeutic margins (e.g. flecainide, propafenone, metoprolol).
Stoga je potreban oprez kad se istodobno primjenjuju Dynastat i lijekovi koje pretežno metabolizira CYP2D6 i koji imaju uske terapijske granice (npr. flekainid, propafenon, metoprolol).
Concomitant use with opioid analgesics
Istodobna primjena opioidnih analgetika
Some of these reactions have occurred in patients with a history of allergic-type reactions to sulfonamides (see section 4.3).
Neke od tih reakcija nastale su u bolesnika koji su u povijesti bolesti imali alergijski tip reakcije na sulfonamide (vidjeti dio 4.3).
Based on the mechanism of action, the use of NSAIDs, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women.
Na temelju mehanizma djelovanja, primjena nesteroidnih protuupalnih lijekova može odgoditi ili spriječiti rupturu folikula jajnika što se povezuje s reverzibilnom neplodnosti u nekih žena.
After IV or IM dosing of parecoxib, the elimination half-life (t1/2) of valdecoxib is about 8 hours.
Nakon i.v. ili i.m. doziranja parekoksiba, poluvijek eliminacije (t1/2) valdekoksiba je oko 8 sati.
Chemical and physical in-use stability of the reconstituted solution have been demonstrated for up to 24 hours at 25C.
Pokazalo se da je rekonstituirana otopina kemijski i fizikalno stabilna do 24 sata na temperaturi od 25C.
Adequate monitoring of methotrexate-related toxicity should be considered when coadministering parecoxib and methotrexate.
Mora se razmotriti odgovarajući nadzor toksičnosti povezane s metotreksatom kad se parekoksib i metotreksat primjenjuju istodobno.
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.
Razlika u antitrombocitnoj aktivnosti između nekih nesteroidnih protuupalnih lijekova koji inhibiraju COX-1 i selektivnih inhibitora COX-2 može biti od kliničkog značaja u bolesnika s rizikom od tromboembolijskih reakcija.
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 sulfonamide moiety.
Valdekoksib se eliminira opsežnim metaboliziranjem u jetri pomoću brojnih metaboličkih puteva, uključujući izoenzime citokroma P450 (CYP) 3A4 i CYP2C9 i glukuronidaciju (oko 20%) sulfonamidnog dijela.
- If you have further questions, ask your doctor or nurse.
- Ako imate dodatnih pitanja, obratite se liječniku ili medicinskoj sestri.
In young subjects, Dynastat 40 mg twice daily had no clinically significant effect on acetylsalicylic acid-mediated inhibition of platelet function (see section 4.5).
U mladih ispitanika, Dynastat u dozi od 40 mg dvaput dnevno nije imao klinički značajnog učinka na inhibiciju funkcije trombocita posredovanu acetilsalicilnom kiselinom (vidjeti dio 4.5).
Patients with severe hepatic impairment have not been studied and therefore the use of Dynastat in patients with severe hepatic impairment is not recommended (see sections 4.2 and 4.3).
Bolesnici s teškim oštećenjem jetre nisu ispitani i stoga se primjena Dynastata u bolesnika s teškim oštećenjem jetre ne preporučuje (vidjeti dijelove 4.2 i 4.3).
Coadministration 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.
Istodobna primjena valdekoksiba i litija izazvala je značajno smanjenje serumskog klirensa (25%) i bubrežnog klirensa (30%) litija uz 34% veću serumsku izloženost u odnosu na primjenu samo litija.
Use of water for injection is not recommended, as the resulting solution is not isotonic.
Primjena vode za injekcije se ne preporučuje, jer dobivena otopina nije izotonična.
However, for elderly patients weighing less than 50 kg, treatment should be initiated with half the usual recommended dose of Dynastat and reduce the maximum daily dose to 40 mg (see section 5.2).
Međutim, u starijih bolesnika tjelesne težine manje od 50 kg, liječenje se mora započeti polovicom uobičajeno preporučene doze Dynastata i sniziti maksimalnu dnevnu dozu na 40 mg (vidjeti dio 5.2).
Do not use Dynastat if you currently have a gastric or intestinal ulcer or gastrointestinal bleeding
Nemojte primjenjivati Dynastat ako trenutno imate čir na želucu ili crijevima ili krvarite u probavni trakt
In animals, administration of prostaglandin synthesis inhibitors, including parecoxib, has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality (see sections 5.1 and 5.3).
Ispitivanja na životinjama pokazala su da primjena inhibitora sinteze prostaglandina, uključujući i parekoksib rezultira u povećanom preimplantacijskom i postimplantacijskom gubitku i letalitetu embrija i fetusa (vidjeti dijelove 5.1 i 5.3).
Dynastat had no effect on acetylsalicylic acid-mediated inhibition of platelet aggregation or bleeding times.
Dynastat nije imao učinka na inhibiciju agregacije trombocita posredovanu acetilsalicilnom kiselinom ili na vrijeme krvarenja.
2 ml solvent ampoule contains sodium chloride, hydrochloric acid, sodium hydroxide and water for injection.
Ampula s 2 ml otapala sadrži natrijev klorid, kloridnu kiselinu, natrijev hidroksid i vodu za injekciju.
In patients with varying degrees of renal impairment administered 20 mg IV Dynastat, parecoxib was rapidly cleared from plasma.
U bolesnika s različitim stupnjevima oštećenja bubrega kojima se intravenski dao Dynastat od 20 mg, parekoksib se brzo uklonio iz plazme.
Plasma clearance (CLp) for valdecoxib is about 6 l/hr.
Klirens plazme (CLp) za valdekoksib iznosi oko 6 l/sat.
COX-2 selective inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane.
Selektivni inhibitori COX-2 smanjuju stvaranje sistemskog (pa stoga moguće i endotelijalnog) prostaciklina bez utjecaja na trombocitni tromboksan.
Caution should be used when initiating treatment with Dynastat in patients with dehydration.
Potreban je oprez kad se započinje liječenje Dynastatom u dehidriranih bolesnika.
Administration of a single dose of parecoxib to lactating women following caesarean section resulted in the transfer of a relatively small amount of parecoxib and its active metabolite valdecoxib into human milk, and this resulted in a low relative dose for the infant (approximately 1% of the weight-adjusted maternal dose).
Primjena jedne doze parekoksiba u dojilja nakon carskog reza rezultirala je prijenosom relativno male količine parekoksiba i njegovog aktivnog metabolita valdekoksiba u majčino mlijeko, što je rezultiralo malom relativnom dozom za dojenče (otprilike 1% doze u majki ponderirane prema težini).
Valdecoxib, but not parecoxib, is extensively partitioned into erythrocytes.
Valdekoksib se, za razliku od parekoksiba, opsežno raspodjeljuje u eritrocite.
There is further increase in the risk of gastrointestinal adverse effects (gastrointestinal ulceration or other gastrointestinal complications), when parecoxib is taken concomitantly with acetylsalicylic acid (even at low doses).
Taj se rizik od gastrointestinalnih nuspojava (gastrointestinalni ulkusi ili druge gastrointestinalne komplikacije) dodatno povećava kad se parekoksib uzima istodobno s acetilsalicilnom kiselinom (čak i pri niskim dozama).
It is one of a family of medicines called COX-2 inhibitors (this is short for cyclo-oxygenase-2 inhibitors).
Pripada skupini lijekova koji se zovu COX-2 inhibitori (skraćenica za inhibitore ciklooksigenaze-2).
Also contains disodium hydrogen phosphate, phosphoric acid and sodium hydroxide.
Također sadrži natrijev hidrogenfosfat, fosfatnu kiselinu i natrijev hidroksid.
Plasma exposure (AUC and Cmax) to valdecoxib was increased (62% and 19%, respectively) when coadministered with fluconazole (predominantly a CYP2C9 inhibitor), indicating that the dose of parecoxib should be reduced in those patients who are receiving fluconazole therapy.
Izloženost valdekoksibu u plazmi (AUC i Cmax) bila je povećana (62% odnosno 19%) kad se primjenjivao istodobno s flukonazolom (pretežno inhibitorom CYP2C9), što pokazuje da se doza parekoksiba mora sniziti u onih bolesnika koji primaju terapiju flukonazolom.
Serious skin reactions, including erythema multiforme, exfoliative dermatitis and Stevens-Johnson syndrome (some of them fatal) have been reported through post-marketing surveillance in patients receiving parecoxib.
Ozbiljne kožne reakcije, uključujući multiformni eritem, eksfolijativni dermatitis i Stevens-Johnsonov sindrom (od kojih su neki imali smrtni ishod) u bolesnika koji su primali parekoksib zabilježene su tijekom praćenja lijeka nakon stavljanja u promet.
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).
Budući da bubrežna eliminacija valdekoksiba nije važna za njegovu raspoloživost, nisu pronađene promjene u klirensu valdekoksiba čak ni u bolesnika s teškim oštećenjem bubrega ili u bolesnika na dijalizi (vidjeti dio 4.2).
Gastrointestinal studies
Gastrointestinalni učinci
Because of the possibility for increased adverse reactions at higher doses of 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).
Zbog povećane mogućnosti nuspojava kod viših doza parekoksiba, drugih inhibitora COX-2 i nesteroidnih protuupalnih lijekova, bolesnike koji se liječe parekoksibom mora se pregledati nakon povišenja doze i, u slučaju da nije došlo do povećanja djelotvornosti, moraju se razmotriti druge terapijske opcije (vidjeti dio 4.2).
Data from 3 randomised placebo-controlled trials, where the protocols allowed treatment of parecoxib for >3 days was pooled and analysed.
Objedinjeni su i analizirani podaci iz 3 placebom kontrolirana randomizirana ispitivanja u kojima su protokoli ispitivanja dozvoljavali liječenje parekoksibom u trajanju > 3 dana.
Parecoxib is rapidly hydrolysed to the active metabolite valdecoxib.
Parekoksib se brzo hidrolizira do djelatnog metabolita valdekoksiba.
The metabolism of valdecoxib may increase when coadministered with enzyme inducers such as rifampicin, phenytoin, carbamazepine or dexamethasone.
Metabolizam valdekoksiba može biti pojačan kad se istodobno primjenjuju induktori enzima kao što su rifampicin, fenitoin, karbamazepin ili deksametazon.
There is limited clinical experience with Dynastat treatment beyond three days (see section 5.1).
Kliničko je iskustvo s liječenjem Dynastatom duljim od tri dana ograničeno (vidjeti dio 5.1).
Plasma exposure (AUC and Cmax) to valdecoxib was increased (38% and 24%, respectively) when coadministered with ketoconazole (CYP3A4 inhibitor), however, a dosage adjustment should not generally be necessary for patients receiving ketoconazole.
Izloženost valdekoksibu u plazmi (AUC i Cmax) bila je povećana (38% odnosno 24%) kad se istodobno primjenjivao ketokonazol (inhibitor CYP3A4), međutim, prilagodba doziranja općenito ne bi trebala biti neophodna u bolesnika koji primaju ketokonazol.
Manufacturer: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium
Proizvođač: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgija
Parecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Primjena parekoksiba mora se prekinuti kod prve pojave kožnog osipa, lezija sluznica ili drugih znakova preosjetljivosti.
The occurrence of adverse events in patients receiving parecoxib for 4-7 days (median duration 4 days) was low after treatment Day 3 and similar to placebo.
Pojava štetnih događaja u bolesnika koji su primali parekoksib od 4 do 7 dana (medijan trajanja iznosio je 4 dana) bila je rijetka nakon 3. dana liječenja i slična onoj zabilježenoj kod primjene placeba.
What Dynastat looks like and contents of the pack Dynastat is available as a white to off-white powder.
Dynastat je dostupan kao bijeli do gotovo bijeli prašak.
For storage conditions of the reconstituted medicinal product see section 6.3.
Uvjete čuvanja nakon rekonstitucije lijeka vidjeti u dijelu 6.3.