natgillin/translations-raw huggingface dataset:
200 mg (1 mg/ml) after reconstitution
200 mg (1 mg/ml) po rekonstituciji
1 Bottle
1 plastenka
200 mg Powder for oral solution Oral use
200 mg prašek za peroralno raztopino
Invented name Strength Pharmaceutical form Route of administration Packaging
številka EU ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija)
20 mg Gastro-resistant capsule, hard
20 mg gastrorezistentna kapsula, trda peroralna uporaba plastenka (HDPE)
(Invented) name Strength Pharmaceutical form Route of administration
Jakost Farmacevtska oblika Pot uporabe
Bottle (HDPE) 14 capsules
14 kapsul
As a result, levodopa remains active for longer.
Posledično ostane levodopa aktivna dlje.
It can be taken with or without food.
Zdravilo se lahko jemlje s hrano ali brez nje.
The marketing authorisation was renewed on 16 September 2003 and on 16 September 2008.
Dovoljenje za promet z zdravilom je bilo obnovljeno dne 16. septembra 2003 in 16. septembra 2008.
The patients then lose their ability to control their movements reliably.
Bolniki zatem izgubijo zmožnost zanesljivega nadzora nad svojimi gibi.
It is available as brown-orange tablets (200 mg).
Na voljo je v obliki rjavkastooranžnih tablet (200 mg).
Other information about Comtess:
Druge informacije o zdravilu Comtess:
It should not be used with combinations that are ‘modified release' (when the levodopa is released slowly over a few hours).
Ne sme se ga uporabljati v kombinacijah s „prilagojenim sproščanjem“ (kjer se levodopa počasi sprošča v obdobju več ur).
What benefit has Comtess shown during the studies?
Kakšne koristi je zdravilo Comtess izkazalo med študijami?
The European Commission granted a marketing authorisation valid throughout the European Union for Comtess on 16 September 1998.
Evropska komisija je dovoljenje za promet z zdravilom Comtess, veljavno po vsej Evropski uniji, odobrila dne 16. septembra 1998.
The Committee recommended that Comtess be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Comtess odobri dovoljenje za promet.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) COMTESS EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) COMTESS Povzetek EPAR za javnost
Comtess is used to treat patients with Parkinson's disease.
Zdravilo Comtess se uporablja za zdravljenje bolnikov s Parkinsonovo boleznijo.
When patients first add Comtess to their existing medication, they may need to take a lower daily dose of levodopa, either by changing how often they take it, or by reducing the amount of levodopa taken in each dose.
Ko bolnik prvič doda zdravilo Comtess svojim obstoječim zdravilom, bo morda moral vzeti manjši dnevni odmerek levodope, kar lahko doseže tako, da bodisi spremeni pogostost jemanja levodope ali pa zmanjša količino levodope, zaužite v vsakem odmerku.
Comtess should not be used in patients with:
Zdravila Comtess ne smejo uporabljati bolniki:
• liver disease;
• z obolenji jeter,
• a history of neuroleptic malignant syndrome (a dangerous nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres).
• ki so imeli v preteklosti nevroleptični maligni sindrom (nevarno obolenje živčnega sistema, ki ga običajno povzročijo antipsihotična zdravila) ali rabdomiolizo (razgradnjo mišičnih vlaken).
Fluctuations happen when the effects of the medication wear off and symptoms re-emerge.
Do nihanj pride, ko začnejo učinki zdravil popuščati in se ponovno pojavijo značilni simptomi.
The main measure of effectiveness was the time spent in the ‘on' state (the time when levodopa is controlling the symptoms of Parkinson's disease) after the first levodopa dose of the morning in the first study, and over one day in the second study.
Glavno merilo učinkoitosti je bil čas, ko je bilo bolnikovo stanje dobro (stanje „vklopa“, ko je levodopa nadzorovala simptome Parkinsonove bolezni), in sicer po prvem jutranjem odmerku levodope v prvi študiji in v teku celega dne v drugi študiji.
What is the risk associated with Comtess?
Kakšna tveganja so povezana z zdravilom Comtess?
Comtess is a medicine that contains the active substance entacapone.
Comtess je zdravilo, ki vsebuje zdravilno učinkovino entakapon.
Comtess should not be used in people who may be hypersensitive (allergic) to entacapone or any of the other ingredients.
Zdravila Comtess ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) entakapon ali katero koli drugo sestavino zdravila.
Comtess was more effective than placebo in both studies.
V obeh študijah je bilo zdravilo Comtess učinkovitejše od placeba.
It is taken as one tablet with each dose of the other medicine, up to a maximum of 10 tablets a day.
Bolnik zaužije eno tableto zdravila Comtess skupaj z vsakim odmerkom drugega zdravila, vendar največ 10 tablet na dan.
In the first study, adding Comtess increased the ‘on' time by 1 hour and 18 minutes more than adding placebo.
V prvi študiji je dodajanje zdravila Comtess podaljšalo trajanje stanja „vklopa“ za 1 uro in 18 minut v primerjavi s placebom.
In the second study, the ‘on' time was increased by 35 minutes compared with placebo.
V drugi študiji je bil v primerjavi s placebom ta čas daljši za 35 minut.
Why has Comtess been approved?
Zakaj je bilo zdravilo Comtess odobreno?
The most common side effects with Comtess (seen in between 1 and 10 patients in 100) are dyskinesia (uncontrollable movements), nausea (feeling sick) and harmless urine discoloration.
Najpogostejši neželeni učinki zdravila Comtess (opaženi pri 1 do 10 bolnikih izmed 100) so diskinezija (nekontrolirani gibi), navzeja (občutek slabosti) in nenevarna sprememba barve urina.
It only works when it is taken with levodopa, a copy of the neurotransmitter dopamine that can be taken by mouth.
Deluje samo pri uporabi skupaj z levodopo, kopijo živčnega prenašalca dopamina, ki se jo lahko jemlje peroralno.
Comtess has been studied in a total of 376 patients with Parkinson's disease, in two six-month studies that measured the effects of adding Comtess or placebo (a dummy medicine) to the patient's combination of levodopa and carbidopa or levodopa and benserazide.
Zdravilo Comtess so preučevali pri skupno 376 bolnikih s Parkinsonovo boleznijo v dveh šestmesečnih študijah, v katerih so merili učinke dodajanja zdravila Comtess ali placeba (zdravila brez zdravilne učinkovine) bolnikovi kombinaciji levodope in karbidope oziroma levodope in benserazida.
For the full list of all side effects reported with Comtess, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Comtess, glejte navodilo za uporabo.
• phaeochromocytoma (a tumour of the adrenal gland);
• s feokromocitomom (tumorjem nadledvične žleze),
The active substance in Comtess, entacapone, works to restore the levels of dopamine in the parts of the brain that control movement and co-ordination.
Zdravilna učinkovina v zdravilu Comtess, entakapon, deluje tako, da ponovno vzpostavi ravni dopamina v delih možganov, ki nadzorujejo gibe in njihovo usklajenost.
They are linked with a reduction in the effects of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and having difficulties moving about.
Nihanja so povezana z zmanjšanjem učinka levodope, ko bolnik doživlja nenadne preskoke med stanjem, ko se lahko giblje (stanje „vklopa“), in med stanjem, ko ima z gibanjem težave (stanje „izklopa“).
Comtess should not be used together with other medicines that belong to the group ‘monoamine oxidase inhibitors' (a type of antidepressant).
Zdravilo Comtess se ne sme jemati hkrati z drugimi zdravili, ki spadajo v skupino zaviralcev monoaminooksidaze (vrste antidepresivov).
Comtess can only be used with conventional combinations of levodopa.
Zdravilo Comtess se lahko uporablja le s standardnimi kombinacijami levodope.
The full EPAR for Comtess is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Comtess je na voljo tukaj.
See the Summary of Product Characteristics (also part of the EPAR) for full details.
Za podrobne informacije glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
Comtess is used together with levodopa (either a combination of levodopa and benserazide or a combination of levodopa and carbidopa) when the patient is having ‘fluctuations' towards the end of the period between two doses of their medication.
Zdravilo Comtess se uporablja skupaj z levodopo (bodisi v kombinaciji z levodopo in benserazidom ali kombinaciji z levodopo in karbidopo), kadar bolnik doživlja „nihanja“ proti koncu obdobja med dvema odmerkoma zdravil.
Comtess is used when these fluctuations cannot be treated with the standard levodopacontaining combination alone.
Zdravilo Comtess se uporablja, kadar nihanj ne moremo zdraviti samo s standardno kombinacijo, ki vsebuje levodopo.
Comtess is only used in combination either with levodopa and benserazide or with levodopa and carbidopa.
Zdravilo Comtess se uporablja samo v kombinaciji z levodopo in benserazidom oziroma levodopo in karbidopo.
This helps to improve the symptoms of Parkinson's disease, such as stiffness and slowness of movement.
To olajša simptome Parkinsonove bolezni, kot sta otrdelost mišic in upočasnjeno izvajanje gibov.
The Committee for Medicinal Products for Human Use (CHMP) decided that Comtess's benefits are greater than its risks as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa for use in patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Comtess kot dodatka k standardnima kombinacijama levodope/benserazida oziroma levodope/karbidope za zdravljenje bolnikov s Parkinsonovo boleznijo in motoričnimi nihanji ob koncu delovanja odmerka, ki jih ne moremo stabilizirati z navedenimi kombinacijami, večje od z njim povezanih tveganj.
Entacapone blocks an enzyme that is involved in the breakdown of levodopa in the body called
Entakapon blokira encim, imenovan katehol-O-metiltransferaza (COMT), ki sodeluje pri razgradnji levodope v telesu.
How does Comtess work?
Kako zdravilo Comtess deluje?
How has Comtess been studied?
Kako je bilo zdravilo Comtess raziskano?
What is Comtess used for?
Za kaj se zdravilo Comtess uporablja?
How is Comtess used?
Kako se zdravilo Comtess uporablja?
What is Comtess?
Kaj je zdravilo Comtess?
Patients under 18 years of age.
Bolniki, mlajši od 18 let.
These beneficial effects were maintained for up to 52 weeks.
Ti koristni učinki so se vzdrževali do 52 tednov dolgo.
Further to the assessment of:
v zvezi z vrednotenjem:
On 23 June 2005, the CHMP concluded that:
Dne 23. junija je CHMP zaključil, da:
The volume of distribution (Vss) is 9 L.
Porazdelitveni prostor (Vss) je 9 l.
Patients should not exceed this dose.
Bolniki ne smejo prekoračiti tega odmerka.
The undesirable effects profile was generally similar to that reported in the OA and RA studies.
Profil neželenih učinkov je bil na splošno podoben tistemu, o katerem so poročali v študijah OA in RA.
However, exposure is limited to clinical trials.
Vendar pa je izpostavljenost omejena na klinična preizkušanja.
The CHMP confirmed changes to the Product Information already introduced through a type II variation adopted in May 2005 and requested further changes.
CHMP je potrdil spremembe Informacij o zdravilu, že vnešene z variacijo tipa II, sprejeto maja 2005 in zahteval še nadaljne spremembe.
[Common (>1/100, <1/10) Uncommon (>1/1000, <1/100) Rare (>1/10,000, <1/1,000) Very rare
[pogosti (>1/100, <1/10) občasni (>1/1.000, <1/100) redki (>1/10.000, <1/1.000) zelo redki
Median tmax is about 2 hours post dose.
Mediani tmax je okrog 2 uri po odmerku.
Dosage adjustment in the elderly is not necessary.
Prilagajanje odmerjanja pri starejših osebah ni potrebno.
Plasma clearance is 7.7 L/h.
Plazemski očistek je 7,7 l/h.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY AND ICELAND
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE IN IMETNIKOV DOVOLJENJ ZA PROMET Z ZDRAVILI V DRŽAVAH ČLANICAH TER NA NORVEŠKEM IN ISLANDIJI
In elderly subjects (over 65 years old), a 15% increase in AUC was observed as compared to younger subjects.
Pri starejših osebah (starejših od 65 let) so opazili 15-odstotno zvečanje AUC v primerjavi z mlajšimi osebami.
In addition various conjugates (glucuronides and sulfates) of these metabolites are formed.
Poleg tega nastajajo različni konjugati(glukuronidi in sulfati) teh presnovkov.
Clear PVC/aluminium blisters in packs containing 2, 4, 5, 6, 10, 20, 30, 50, 100, or 600 film-coated tablets.
Prozorni pretisni omoti iz PVC/aluminija v škatlah, ki vsebujejo po 2, 4, 5, 6, 10, 20, 30, 50, 100 ali 600 filmsko obloženih tablet.
Therefore, the combination should be administered with caution, especially in the elderly.
Zato je treba to kombinacijo uporabljati zelo previdno, posebno pri starejših bolnikih.
Elderly: As with other drugs used in the elderly, it is prudent to initiate treatment with the lower recommended dose.
Starejši bolniki: Podobno kot pri drugih zdravilih, ki se uporabljajo pri starejših bolnikih, je pametno začeti zdravljenje z najmanjšim priporočenim odmerkom.
To support multiple venues for healthcare professionals including prescribers and pharmacists.
Da se bo zavzel za to, da se poklicni zdravstveni delavci vključno s predpisovalci in farmacevti, večkrat srečajo.
In patients who fail to respond, the dose may be increased to 200 mg daily in one or two divided doses.
Pri bolnikih, ki se ne odzovejo, se lahko odmerek zveča na 200 mg na dan v enem ali dveh razdeljenih odmerkih.
Camberley Surrey GU16 7SR United Kingdom
Camberley Surrey GU16 7SR Velika Britanija
Further to the assessment of the data on serious skin reactions, lumiracoxib does not appear to be associated with an unusually large number of reports of serious skin reactions.
Po vrednotenju podatkov o hudih kožnih reakcijah, se ne zdi, da bi bil lumirakoksib povezan z neobičajno velikim številom poročil o hudih kožnih reakcijah.
The cardiovascular safety of lumiracoxib beyond 1 year of use has not been established.
Kardiovaskularne varnosti lumirakoksiba za čas uporabe, daljši od enega leta, niso ugotovili.
Randomization was stratified by low-dose ASA use (24% of patients in the overall study population) and age.
Randomizacija je bila stratificirana po uporabi ASA v majhnih odmerkih (24 % bolnikov v celotni populaciji študije) in po starosti.
Paediatric use: {Invented Name} has not been studied in children and thus is contraindicated in children under 18 years of age.
Uporaba pri otrocih: Zdravila {IZMIŠLJENO IME} pri otrocih niso proučevali, zato je pri otrocih, mlajših od 18 let, kontraindicirano.
To conduct a Prescription Event Monitoring study.
Da bo izvedel študijo o spremljanju predpisovanja zdravil.
The use of lumiracoxib in pregnant women has not been studied in adequate and well controlled clinical trials and therefore it should not be used during the first two trimesters of pregnancy unless the potential benefit to the patients justifies the potential risk to the fetus.
Uporabe lumirakoksiba pri nosečnicah niso proučili v ustreznih in dobro kontroliranih kliničnih preskusih, zato ga v prvih dveh trimesečjih nosečnosti ne smemo uporabljati, razen če možna korist za bolnico upravičuje možno tveganje za plod.
The maximum treatment duration in clinical studies was 12 months.
Najdaljše trajanje zdravljenja v kliničnih študijah je bilo 12 mesecev.
Hypertensive Patients:
Hipertenzivni bolniki:
In the post-orthopedic surgery pain studies, anemia was reported more frequently, although the frequency was similar to placebo.
V študijah bolečin po ortopedskih operacijah so pogosteje poročali o anemiji, čeprav je bila njena pogostost podobna kot pri placebu.
The absolute bioavailability of lumiracoxib is approximately 74%.
Absolutna biološka uporabnost lumirakoksiba je približno 74 %.
The recommended starting dose is 100 mg once daily.
Priporočeni začetni odmerek je 100 mg enkrat na dan.
CYP2C9 polymorphism:
Polimorfizem CYP2C9:
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, PREDSTAVLJENEGA S STRANI EVROPSKE AGENCIJE ZA ZDRAVILA
Following 400 mg once daily dosing, Cmax was about 9 µg/ml and AUC was about 31 µg h/ml.
Po odmerjanju 400 mg enkrat na dan je bila Cmax okrog 9 µg/ml, AUC pa okrog 31 µg h/ml.
Hypromellose, Macrogol, talc, iron oxide red (E172), iron oxide black (E172) and titanium dioxide (E171)
Hipromeloza, makrogol, smukec, rdeči železov oksid (E172), črni železov oksid (E172) in titanov dioksid (E171).
In a long-term controlled study with lumiracoxib 400 mg daily, rare cases of hepatitis have been reported (see section 4.8).
V dolgoročni kontrolirani študiji z lumirakoksibom v odmerku 400 mg na dan so poročali o redkih primerih hepatitisa (glejte poglavje 4.8).
Renal prostaglandins may play a compensatory role in the maintenance of renal perfusion.
Možno je, da imajo ledvični prostaglandini kompenzacijsko vlogo pri vzdrževanju perfuzije ledvic.
Between November 2004 and June 2005, the MAH made an oral explanation to the CHMP on cardiovascular and skin safety aspects for lumiracoxib on 18 January 2005.
Med novembrom 2004 in junijem 2005 je imetnik dovoljenja za promet 18. januarja 2005 pred CHMP ustno obrazložil kardiovaskularne in kožne varnostne vidike za lumirakoksib.
Patients with congestive heart failure (NYHA II-IV).
Bolniki s kongestivnim srčnim popuščanjem (NYHA II-IV).
The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks (see section 4.3 and 4.4).
Odločitev, da se predpiše selektivni zaviralec COX-2, mora temeljiti na ocenitvi vseh tveganj za vsakega posameznega bolnika (glejte poglavji 4.3 in 4.4).
Third trimester of pregnancy and breast feeding (see section 4.6 and 5.3).
Tretje trimesečje nosečnosti in dojenje (glejte poglavji 4.6 in 5.3).
However, the APTC event rate was numerically higher for lumiracoxib than for naproxen but lower than for ibuprofen.
Vendar je bila frekvenca APTC dogodkov številčno večja pri lumirakoksibu kot pri naproksenu, a manjša kot pri ibuprofenu.
Diuretics, ACE inhibitors and Angiotensin II antagonists: NSAIDs may reduce the effect of diuretics and antihypertensive drugs.
Diuretiki, zaviralci ACE in antagonisti angiotenzina II: NSAR lahko zmanjšajo učinek diuretikov in antihipertenzivnih zdravil.
Therefore antiplatelet therapies should not be discontinued (see section 4.5 and 5.1).
Zato antiagregacijskega zdravljenja ne smemo ukiniti (glejte poglavji 4.5 in 5.1).
{Invented Name} film-coated tablets are administered orally and may be taken with or without food.
{IZMIŠLJENO IME} filmsko obložene tablete so za peroralno uporabo in se lahko jemljejo s hrano ali brez nje.
{Invented Name} 100 mg and 200 mg film-coated tablets contain lactose (23.3 mg and 46.6 mg, respectively).
{IZMIŠLJENO IME}100 mg in 200 mg filmsko obložene tablete vsebujejo laktozo (23,3 mg oziroma 46,6 mg).
In the event of suspected overdose, appropriate supportive medical care should be provided e.g. by eliminating the gastric contents, clinical supervision and, if necessary, the institution of symptomatic treatment.
V primeru suma na prevelik odmerek je treba nuditi ustrezno podporno medicinsko oskrbo, na primer odstranitev želodčne vsebine, klinični nadzor, po potrebi pa tudi uvesti simptomatsko zdravljenje.
Other NSAIDs: Lumiracoxib can be used with low-dose aspirin.
Drugi NSAR: Lumirakoksib se lahko uporablja z majhnimi odmerki aspirina.
Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids, coxibs, ATC code: M01 AH 06
Farmakoterapevtska skupina: Nesteroidna protivnetna in protirevmatična zdravila, koksibi, Oznaka ATC: M01 AH 06.
Administration of 100 mg, 200 mg or 400 mg once daily leads to >90% peak inhibition of COX-2.
Uporaba 100 mg, 200 mg ali 400 mg enkrat na dan povzroči >90 % največje inhibicije COX-2.
Acute pain
Akutna bolečina
Over the range of 25 to 800 mg, extent of exposure (AUC) increases in a dose-proportional manner and the peak plasma concentration (Cmax) was roughly dose-proportional.
V mejah med 25 in 800 mg se obseg izpostavljenosti (AUC) zvečuje sorazmerno odmerku, najvišja koncentracija v plazmi (Cmax) je bila približno sorazmerna odmerku.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take 100 mg and 200 mg film-coated tablets.
Bolniki z redkimi dednimi boleznimi: intoleranco galaktoze, laponskim pomanjkanjem laktaze ali glukozno-galaktozno malabsorpcijo ne smejo jemati 100-miligramskih in 200-miligramskih filmsko obloženih tablet.
No special precautions for storage.
Za shranjevanje zdravila niso potrebna posebna navodila.
In vitro studies indicate that lumiracoxib is not a significant inhibitor of other cytochrome P450 isoforms, including CYP1A2, CYP2C8, CYP 2C19, CYP2D6, CYP2E1, and CYP3A4.
Študije in vitro kažejo, da lumirakoksib ni pomemben zaviralec drugih izoform citokroma P450, na primer CYP1A2, CYP2C8, CYP 2C19, CYP2D6, CYP2E1 in CYP3A4.
This indicates lumiracoxib and/or its metabolites are preferentially distributed and retained in inflamed tissue.
To kaže, da se lumirakoksib in/ali njegovi presnovki prednostno porazdeljujejo in zadržujejo v vnetem tkivu.
Compared to a daily dose of 200 mg, a daily dose of 400 mg of lumiracoxib is associated with a relatively higher frequency of drug-related adverse events, especially the gastrointestinal, neurological and psychiatric events.
V primerjavi z dnevnim odmerkom 200 mg je dnevni odmerek 400 mg lumirakoksiba povezan z relativno večjo pogostostjo neželenih učinkov, povezanih z zdravilom, posebno gastrointestinalnih, nevroloških in psihiatričnih dogodkov.
At 15 minutes post 400 mg dose, the plasma concentration reached 0.6 µg/ml, which is sufficiently high to achieve over 90% inhibition of COX-2.
15 minut po 400-miligramskem odmerku je plazemska koncentracija dosegla 0,6 µg/ml, ki zadostuje za preko 90-odstotno inhibicijo COX-2.
Two isoforms, COX-1 and COX-2 have been identified.
Identificirali so dve izoobliki, COX-1 in COX-2.
Patients appear to be at highest risk for these reactions early in the course of therapy, with the onset of the reaction occurring in the majority of cases within the first month of treatment.
Kaže, da je tveganje za te reakcije največje kmalu po začetku zdravljenja: v večini primerov so reakcije nastopile v prvem mesecu zdravljenja.
The concentration of 4'-hydroxy metabolite in plasma and synovial fluid is low, thus it is unlikely to contribute to efficacy.
Koncentracija 4'-hidroksi presnovka v plazmi in sinovialni tekočini je nizka, zato ni verjetno, da bi ta presnovek prispeval k učinkovitosti zdravila.
If there is clinical evidence of deterioration in the condition of these patients, appropriate measures including discontinuation of lumiracoxib should be taken.
Če se pri teh bolnikih pojavijo klinični znaki poslabšanja stanja, so potrebni ustrezni ukrepi, vključno z ukinitvijo lumirakoksiba.
These data resulted in the worldwide withdrawal of Vioxx (rofecoxib) from the market on 30 September 2004 by the MAH and raised questions regarding the cardiovascular safety of other Cox-2 inhibitors.
Zaradi teh podatkov je imetnik dovoljenja za promet dne 30. septembra 2004 z vseh svetovnih tržišč umaknil zdravilo Vioxx (rofekoksib), pojavila pa so se tudi vprašanja o kardiovaskularni varnosti drugih zaviralcev Cox-2.
The use of lumiracoxib is contraindicated in the last trimester of pregnancy because, as with other drugs known to inhibit prostaglandin synthesis, it may cause uterine inertia and premature closure of the ductus arteriosus.
Uporaba lumirakoksiba je kontraindicirana v zadnjem trimesečju nosečnosti, ker, podobno kot druga zdravila, za katera je znano, da zavirajo sintezo prostaglandinov, lahko povzroča inertnost maternice in prezgodnje zapiranje duktusa arteriozusa.