natgillin/translations-raw huggingface dataset:
Most commonly reported adverse reactions are of gastrointestinal character and are seen in approximately 7% of the patients.
Neželeni učinki, o katerih so najpogosteje poročali, so gastrointestinalne narave in so jih opažali pri približno 7% bolnikov.
These adverse reactions do not usually lead to discontinuation of the treatment.
Ti neželeni učinki običajno ne vodijo v prekinitev zdravljenja.
Adverse reactions are ranked according to frequency using the following convention:
Neželeni učinki so navedeni po pogostnosti z uporabo naslednjega dogovora:
Very common (> 1/ 10), Common (> 1/ 100 ,< 1/10), Uncommon (> 1/ 1,000 ,< 1/100), Rare (> 1/ 10,000, < 1/ 1,000), Very rare (< 1/ 10,000), including isolated reports:
Zelo pogosti (> 1/ 10), Pogosti (> 1/ 100, < 1/ 10), Občasni (> 1/ 1. 000, < 1/ 100), Redki (> 1/ 10. 000, < 1/ 1. 000), Zelo redki (< 1/ 10. 000), vključno s posameznimi primeri:
Platelet, bleeding and clotting disorders Rare: thrombocytopenia.
Bolezni trombocitov, krvavitve in motnje strjevanja krvi Redki: trombocitopenija.
Rare: severe anaemia.
Bolezni eritrocitov Redki: huda anemija.
Self-limiting, mild haemoglobin and haematocrit decrease have been observed on initiating gemfibrozil therapy.
Ob uvajanju zdravljenja z gemfibrozilom so opažali blaga znižanja vrednosti hemoglobina in hematokrita, ki so prenehala sama.
White cell and reticuloendothelial system disorders Rare: leucopoenia, eosinophilia, bone marrow hypoplasia.
Bolezni levkocitov in retikuloendotelijskega sistema Redki: levkopenija, eozinofilija, hipoplazija kostnega mozga.
Self-limiting, white cell decrease has been observed on initiating gemfibrozil therapy.
Ob uvajanju zdravljenja z gemfibrozilom so opažali znižanja koncentracije levkocitov, ki so prenehala sama.
Central and peripheral nervous system Common: vertigo, headache.
18 Centralni in periferni živčni sistem Pogosti: vrtoglavica, glavobol.
Rare: dizziness, somnolence, paresthesia, peripheral neuritis, decreased libido.
Redki: omotica, somnolenca, parestezija, periferni nevritis, zmanjšanje libida.
Vision disorders Rare: blurred vision.
Motnje vida Redki: zamegljen vid.
Heart rate and rhythm disorders Uncommon: atrial fibrillation.
Motnje srčne frekvence in ritma Občasni: atrijska fibrilacija.
Gastro-intestinal system disorders Very common: dyspepsia.
Bolezni prebavil Zelo pogosti: dispepsija.
Common: abdominal pain, diarrhoea, flatulence, nausea, vomiting, constipation.
Pogosti: bolečine v trebuhu, diareja, flatulenca, navzea, bruhanje, zaprtje.
Rare: pancreatitis, acute appendicitis.
Redki: pankreatitis, akutni apendicitis.
Liver and biliary system disorders Rare: cholestatic jaundice, disturbed liver function, hepatitis, cholelithiasis, cholecystitis.
Bolezni jeter, žolčnika in žolčevodov Redki: holestatska zlatenica, motnje delovanja jeter, hepatitis, holelitiaza, holecistitis.
Skin and appendages disorders Common: eczema, rash.
Bolezni kože in adneksov Pogosti: ekcem, izpuščaj.
Rare: exfoliative dermatitis, dermatitis, pruritus, alopecia.
Redki: eksfoliativni dermatitis, dermatitis, pruritus, alopecija.
Musculoskeletal disorders Rare: arthralgia, synovitis, myalgia, myopathy, myasthenia, painful extremities and myositis accompanied by increase in creatine kinase (CK), rhabdomyolysis.
Bolezni mišično- skeletnega sistema Redki: artralgija, sinovitis, mialgija, miopatija, miastenija, bolečine v okončinah in miozitis s spremljajočimi povišanimi vrednostmi kreatin- kinaze (CK – » creatine kinase «), rabdomioliza.
Urinary system disorders Rare: impotence.
Bolezni sečil Redki: impotenca.
Body as a whole-general disorders Common: fatigue.
Telo v celoti - splošne težave Pogosti: utrujenost.
Rare: photosensitivity, angioedema, laryngeal edema, urticaria.
Redki: fotosenzitivnost, angioedem, edem grla, urtikarija.
Overdose has been reported.
Poročali so o prevelikem odmerjanju.
Non-specific symptoms reported were nausea and vomiting.
Nespecifična simptoma, o katerih so poročali, sta bila navzea in bruhanje.
The patients fully recovered.
Bolniki so si popolnoma opomogli.
Symptomatic supportive measures should be taken if overdose occurs.
V primeru prevelikega odmerjanja uporabite simptomatske podporne ukrepe.
Serum-lipid lowering agent Chemical subgroup:
Zdravila za zmanjšanje ravni serumskih lipidov Kemijska podskupina:
Fibrates ATC code:
Fibrati Oznaka ATC:
Gemfibrozil is a non-halogenated phenoxypentanoic acid.
Gemfibrozil je nehalogenirana fenoksipentanojska kislina.
Gemfibrozil is a lipid regulating agent which regulates lipid fractions.
Gemfibrozil je učinkovina za uravnavanje lipidov, ki uravnava lipidne frakcije.
Gemfibrozil's mechanism of action has not been definitively established.
Načina delovanje gemfibrozila niso dokončno ugotovili.
In man, gemfibrozil stimulates the peripheral lipolysis of triglyceride rich lipoproteins such as VLDL and cholymicrons (by stimulation of LPL).
Pri človeku gemfibrozil spodbuja periferno lipolizo lipoproteinov, bogatih s trigliceridi, kot so VLDL in hilomikroni (preko spodbujanja LPL).
Gemfibrozil also inhibits synthesis of VLDL in the liver.
Gemfibrozil tudi zavira sintezo VLDL v jetrih.
Gemfibrozil increases the HDL2 and HDL3 subfractions as well as apolipoprotein A-I and A-II.
Gemfibrozil povečuje koncentracije podfrakcij HDL2 in HDL3, pa tudi koncentracije apolipoproteina A- I in A- II.
Animal studies suggest that the turnover and removal of cholesterol from the liver is increased by gemfibrozil.
19 Študije na živalih kažejo, da gemfibrozil povečuje pretok in odstranjevanje holesterola iz jeter.
In the Helsinki Heart Study, which was a large placebo-controlled study with 4081 male subjects, 40 to 55 years of age, with primary dyslipidaemia (predominantly raised non-HDL cholesterol +/ - hypertriglyceridaemia), but no previous history of coronary heart disease, gemfibrozil 600 mg twice daily, produced a significant reduction in total plasma triglycerides, total and low density lipoprotein cholesterol and a significant increase in high density lipoprotein cholesterol.
V študiji Helsinki Heart Study, ki je bila obsežna, s placebom kontrolirana študija s 4. 081 moškimi, starimi od 40 do 55 let, s primarno dislipidemijo (predvsem s povišano koncentracijo ne- HDL holesterola + / - hipertrigliceridemijo), a brez koronarne srčne bolezni v preteklosti, je gemfibrozil 600 mg dvakrat na dan povzročil značilno znižanje plazemske koncentracije celokupnih trigliceridov, celokupnega holesterola in LDL holesterola ter značilno povišanje koncentracije HDL holesterola.
The cumulative rate of cardiac end-points (cardiac death and non-fatal myocardial infarction) during a 5 year follow-up was 27.3/ 1000 in the gemfibrozil group (56 subjects) and 41.4/ 1000 in the placebo group (84 subjects) showing a relative risk reduction of 34.0% (95% confidence interval 8.2 to 52.6, p < 0.02) and an absolute risk reduction of 1.4% in the gemfibrozil group compared to placebo.
Kumulativna stopnja srčnih končnih točk (srčna smrt in miokardni infarkt brez smrtnega izida) v 5 - letnem sledenju je bila 27, 3/ 1000 v skupini gemfibrozila (56 oseb) in 41, 4/ 1000 v skupini placeba (84 oseb), kar kaže zmanjšanje relativnega tveganja za 34, 0% (95% interval zaupanja 8, 2 do 52, 6, p < 0, 02) ter zmanjšanje absolutnega tveganja za 1, 4% v skupini gemfibrozila v primerjavi s placebom.
Diabetes patients and patients with severe lipid fraction deviations showed a 68% and 71% reduction of CHD endpoints, respectively.
Diabetiki ter bolniki s hudimi odkloni lipidnih frakcij so pokazali 68% oziroma 71% znižanje CHD končnih točk.
Absorption Gemfibrozil is well absorbed from the gastro-intestinal tract after oral administration with a bioavailability close to 100%.
Absorpcija Gemfibrozil se po peroralnem dajanju iz prebavil dobro absorbira z biološko razpoložljivostjo blizu 100%.
As the presence of food alters the bioavailability slightly gemfibrozil should be taken 30 minutes before a meal.
Ker navzočnost hrane nekoliko spremeni biološko razpoložljivost, je treba gemfibrozil zaužiti 30 minut pred obrokom.
Peak plasma levels occur in one to two hours.
Najvišje plazemske koncentracije se pojavijo v eni do dveh urah.
After administration of 600 mg twice daily a Cmax in the range 15 to 25 mg/ ml is obtained.
Po dajanju 600 mg dvakrat na dan dosežemo Cmax v razponu med 15 in 25 mg/ ml.
Distribution Volume of distribution at steady state is 9-13 l.
Porazdelitev Volumen porazdelitve v stanju dinamičnega ravnovesja je 9- 13 l.
The plasma protein binding of gemfibrozil and its main metabolite are at least 97%.
Vezava gamfibrozila in njegovega poglavitnega presnovka na plazemske beljakovine je vsaj 97%.
Biotransformation Gemfibrozil undergoes oxidation of a ring methyl group to form successively a hydroxymethyl and a carboxyl metabolite (the main metabolite).
Biološka transformacija Da uspešno tvori hidroksimetilni in karboksilni presnovek (poglavitni presnovek), je gemfibrozil podvržen oksidaciji metilne skupine obroča.
This metabolite has a low activity compared to the mother compound gemfibrozil and an elimination half-life of approximately 20 hours.
Ta presnovek ima v primerjavi z izhodiščno spojino gemfibrozilom nizko aktivnost ter razpolovni čas izločanja približno 20 ur.
The enzymes involved in the metabolism of gemfibrozil are not known.
Encimi, ki sodelujejo v presnovi gemfibrozila, niso znani.
The interaction profile of gemfibrozil is complex (see sections 4.3, 4.4 and 4.5).
Profil medsebojnega delovanja gemfibrozila je zapleten (glejte poglavja 4. 3, 4. 4 in 4. 5).
In vitro and in vivo studies have shown that gemfibrozil inhibits CYP2C8, CYP2C9, CYP2C19, CYP1A2, UGTA1 and UGTA3.
Študije in vitro ter in vivo so pokazale, da gemfibrozil zavira CYP2C8, CYP2C9, CYP2C19, CYP1A2, UGTA1 in UGTA3.
Elimination Gemfibrozil is eliminated mainly by metabolism.
Izločanje Gemfibrozil se izloča predvsem s presnovo.
Approximately 70% of the administered human dose is excreted in the urine, mainly as conjugates of gemfibrozil and its metabolites.
Približno 70% danega odmerka za človeka se izloči v urinu, predvsem v obliki konjugatov gemfibrozila in njegovih presnovkov.
Less than 6% of the dose is excreteed unchanged in the urine.
Manj kot 6% odmerka se v urin izloči nespremenjenega.
Six percent of the dose is found in faeces.
Šest odstotkov odmerka najdemo v blatu.
The total clearance of gemfibrozil is in the range 100 to 160 ml/ min, and the elimination half-life is in the range 1.3 to 1.5 hours.
Skupni očistek gemfibrozila je v razponu med 100 in 160 ml/ min in razpolovni čas izločanja je med 1, 3 in 1, 5 ur.
The pharmacokinetics is linear within the therapeutic dose range.
Farmakokinetika je v okviru terapevtskega razpona odmerkov linearna.
Special patient groups No pharmacokinetic studies have been performed in patients with impaired hepatic function.
Posebne skupine bolnikov Pri bolnikih z okvarjenim delovanjem jeter niso opravili farmakokinetičnih študij.
There are limited data on patients with mild, moderate and non-dialysed severe renal impairment.
O bolnikih z blago in zmerno ledvično okvaro ter o bolnikih s hudo ledvično okvaro, ki pa še niso dializno odvisni, so na voljo le omejeni podatki.
The limited data support the use of up to 1200 mg a day in patients with mild to moderate renal failure not receiving another lipid lowering drug.
Omejeni podatki potrjujejo uporabo do 1200 mg na dan pri bolnikih z blago do zmerno ledvično odpovedjo, ki ne prejemajo drugega zdravila za nižanje koncentracije lipidov.
In a 2-year study of gemfibrozil, subcapsular bilateral cataracts occurred in 10%, and unilateral in 6.3%, of male rats treated at 10 times the human dose.
V 2- letni študiji gemfibrozila so se pri samcih podgan, ki so prejemali 10- kratni odmerek za človeka, pri 10% pojavile subkapsularne obojestranske katarakte, enostranske pa pri 6, 3%.
In a mouse carcinogenicity study at dosages corresponding to 0.1 and 0.7 times the clinical exposure (based on AUC), there were no significant differences from controls in the incidence of tumors.
V študiji kancerogenosti pri miših, ki so prejemale odmerke, ki so ustrezali 0, 1 - in 0, 7- kratniku klinične izpostavljenosti (na podlagi AUC), ni bilo značilnih razlik v pojavnosti tumorjev v primerjavi 20 s kontrolno skupino.
In a rat carcinogenicity study at dosages corresponding to 0.2 and 1.3 times the clinical exposure (based on AUC), the incidence of benign liver nodules and liver carcinomas was significantly increased in high dose males, and the incidence of liver carcinomas increased also in the low dose males, but this increase was not statistically significant.
V študiji kancerogenosti pri podganah, ki so prejemale odmerke, ki so ustrezali 0, 2 - in 1, 3- kratniku klinične izpostavljenosti (na podlagi AUC), je bila pojavnost benignih vozličev na jetrih in karcinomov jeter značilno povečana pri samcih, ki so prejemali visoke odmerke, pojavnost karcinomov jeter je bila povečana tudi pri samcih, ki so prejemali nizke odmerke, vendar to povečanje ni bilo statistično značilno.
Liver tumours induced by gemfibrozil and other fibrates in small rodents are generally considered to be related to the extensive proliferation of peroxisomes in these species and, consequently, of minor clinical relevance.
Za tumorje jeter, ki jih povzroča gemfibrozil in drugi fibrati pri malih glodalcih, splošno velja, da so povezani z obsežno proliferacijo peroksisomov pri tej vrsti in so torej le malo klinično pomembni.
In the male rat, gemfibrozil also induced benign Leydig cell tumors.
Pri samcih podgan je gemfibrozil povzročal tudi benigne tumorje Leydigovih celic.
The clinical relevance of this finding is minimal.
Klinični pomen te ugotovitve je majhen.
In reproductive toxicity studies, administration of gemfibrozil at approximately 2 times the human dose (based on body surface area) to male rats for 10 weeks resulted in decreased fertility.
V študijah vpliva na sposobnost razmnoževanja je dajanje približno 2- kratnega odmerka gemfibrozila za človeka (na podlagi telesne površine) samcem podgan 10 tednov povzročilo zmanjšano plodnost.
Fertility was restored after a drug-free period of 8 weeks.
Plodnost se je povrnila na izhodiščno po 8 tednih po prenehanju dajanja.
Gemfibrozil was not teratogenic in either rats or rabbits.
Gemfibrozil pri podganah ali kuncih ni bil teratogen.
Administration of 1 and 3 times the human dose (based on body surface area) of gemfibrozil to female rabbits during organogenesis caused a dose-related decrease in litter size.
Dajanje 1- kratnega in 3- kratnega odmerka gemfibrozila za človeka (na podlagi telesne površine) kunčjim samicam v obdobju organogeneze je povzročilo od odmerka odvisno zmanjšanje števila potomcev.
Administration of 0.6 and 2 times the human dose (based on body surface area) of gemfibrozil to female rats from gestation Day 15 through weaning caused dose-related decreases in birth weight and suppression of pup growth during lactation.
Dajanje 0, 6 - in 2- kratnega odmerka gemfibrozila za človeka (na podlagi telesne površine) samicam podgan od 15. dneva gestacije do prenehanja sesanja mladičev je povzročilo od odmerka odvisno zmanjšanje porodne telesne mase in zastoj rasti mladičev med sesanjem.
Maternal toxicity was observed in both species and the clinical relevance of decreases in rabbit litter size and rat pup weight is uncertain.
Pri obeh vrstah so opažali toksičnost za matere, klinični pomen zmanjšanja števila potomcev pri kuncih in zmanjšanja mase podganjih mladičev pa ni znan.
[To be implemented nationally]
[Dopolniti nacionalno]
Not all pack sizes may be marketed [To be implemented nationally]
[Dopolniti nacionalno]
CHMP/ 1268/ 04 6.6 Instructions for use and handling
6. 6 Navodila za pripravo in ravnanje z zdravilom
[To be implemented nationally]
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET 21 [Dopolniti nacionalno]
DATE OF FIRST AUTHORIZATION/ RENEWAL OF AUTHORIZATION
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET
DATE OF (PARTIAL) REVISION OF THE TEXT
DATUM (DELNE) REVIZIJE BESEDILA
23/ 22
22
28 November 2005 EMEA/ CHMP/ 324332/ 2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 31 REFERRAL
28. november 2005 EMEA/ CHMP/ 383179/ 2005 MNENJE ODBORA ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) V ZVEZI Z NAPOTITVIJO IZ ČLENA 31
LUMIRACOXIB
LUMIRAKOKSIB
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. eu. int http: / /www. emea. eu. int  EMEA 2005 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Upon consideration of all available data, the CHMP adopted an opinion for lumiracoxib on 23 June 2005 recommending the maintenance of the Marketing Authorisations for lumiracoxib containing medicinal products in the indications stated in the Summary of Product Characteristics as set out in Annex III.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. eu. int http: // www. emea. eu. int EMEA 2005 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Po upoštevanju vseh razpoložljivih podatkov je CHMP dne 23. junija 2005 sprejel mnenje za lumirakoksib, v katerem priporoča ohranitev dovoljenj za promet za zdravila, ki vsebujejo lumirakoksib, za indikacije, navedene v Povzetku glavnih značilnosti zdravila, kot je opredeljeno v Dodatku III.
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
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE IN IMETNIKOV DOVOLJENJ ZA PROMET Z ZDRAVILI V DRŽAVAH ČLANICAH TER NA NORVEŠKEM IN ISLANDIJI
Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom
Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR Velika Britanija
Film-coated tablet
filmsko obložena tableta peroralno
2 Member State
2 Država članica
3 Member State
3 Država članica
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, PREDSTAVLJENEGA S STRANI EVROPSKE AGENCIJE ZA ZDRAVILA
5 SCIENTIFIC CONCLUSIONS FOR THE AMENDMENT OF THE MARKETING AUTHORISATION
5 ZNANSTVENI ZAKLJUČKI ZA DOPOLNILO DOVOLJENJA ZA PROMET
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.
Further to discussions at the CHMP October 2004 plenary meeting, the European Commission recommended that this public health issue on all aspects of cardiovascular safety including thrombotic events and cardio-renal events is the subject of Community referrals under Article 31 of Directive 2001/ 83/ EC, as amended regarding decentrally authorised products containing celecoxib, etoricoxib and lumiracoxib and subject to a review procedure under Article 18 of Council Regulation (EEC) No 2309/ 93, as amended regarding the centrally authorised products containing celecoxib (Onsenal), parecoxib (Dynastat/ Rayzon) and valdecoxib (Bextra/ Valdyn), which were started in November 2004.
Postopka ste se začela novembra 2004.
On 7 April 2005, the FDA (Food and Drug Administration) and the EMEA requested that Pfizer voluntarily withdraw Bextra (valdecoxib) from the market and Pfizer agreed to suspend sale and marketing of Bextra worldwide pending further discussions on the unfavorable risk versus benefit due to data on serious skin reactions.
Podjetje je soglašalo tudi, da po vsem svetu ustavi prodajo in trženje zdravila Bextra do nadaljne razprave o neugodnem razmerju med tveganjem in koristjo v zvezi s podatki o hudih kožnih reakcijah.
the new data provided on rofecoxib by the APPROVe clinical study, which revealed a risk of thrombotic CV events,
novih podatkov, ki jih je za rofekoksib prispevala klinična raziskava APPROVe in, ki kažejo tveganje za trombotične kardiovaskularne dogodke,
- the data on celecoxib presented in the APC study, which suggested a dose-related
podatkov za celekoksib iz raziskave APC, ki so nakazali povečanje tveganja hudih kardiovaskularnih dogodkov, ki so odvisni od odmerka,
- the data on valdecoxib and parecoxib presented in the CABG (Coronary Artery Bypass
podatkov za valdekoksib in parekoksib iz raziskav CABG (Coronary Artery Bypass Graft) in CABG II, ki kažejo višjo stopnjo hudih kardiovaskularnih tromboembolijskih dogodkov v skupinah bolnikov, ki so se zdravili s parekoksibom/ valdekoksibom, v primerjavi s skupino bolnikov, ki je prejemala placebo,
- the data on etoricoxib in the EDGE study and pooled analyses of other clinical trials,
podatkov za etorikoksib iz raziskave EDGE ter analiz združenih podatkov iz drugih kliničnih preizkušanj, ki nakazujejo povezavo z večjim tveganjem za trombotične dogodke v primerjavi z naproksenom;
- the data on lumiracoxib in the Target study, which suggested a small increase in
podatkov za lumirakoksib iz raziskave Target, ki nakazujejo majhno povečanje trombotičnih dogodkov (zlasti miokardnega infarkta) v primerjavi z naproksenom,
thrombotic events (especially myocardial infarction) versus naproxen, all available data show an increased risk of CV adverse reactions for Cox-2 inhibitors as a class and agreed that there is an association between duration and dose of intake and the probability of suffering a CV reaction.
6 vsi dostopni podatki kažejo povečano tveganje neželenih kardiovaskularnih reakcij pri skupini zaviralcev Cox- 2 in soglašal, da obstaja povezava med trajanjem jemanja in odmerki ter verjetnostjo pojava kardiovaskularne reakcije.
6 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.
There were no cases of Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme reported in association with the use of lumiracoxib.
Ni bilo primerov Stevens- Johnsonovega sindroma, toksične epidermalne nekrolize ali multiformnega eritema, ki bi bili povezani z uporabo lumirakoksiba.
The changes of the Product Information related to the CV can be summarised as follows:
Spremembe Informacij o zdravilu v zvezi s kardiovaskularnim sistemom lahko povzamemo, kot sledi:
- Addition of a statement that decision to prescribe a selective COX-2 inhibitor should be based
- dodana je izjava, da mora odločitev, da se predpiše selektiven zaviralec COX- 2, temeljiti na
on an assessment of the individual patient's overall risks.
vrednotenju celotnega tveganja posameznega bolnika;
- Addition of a statement that prescribers should use the lowest effective dose, for the shortest
- dodana je izjava, da naj predpisovalci zdravila uporabljajo najnižji učinkovit odmerek za
possible duration, and that the need for pain relief should be re-evaluated frequently.
najkrajši možni čas trajanja ter da je potrebo za lajšanje bolečin potrebno pogosto ponovno oceniti.
disease and Peripheral arterial disease.
obolenje ter Periferna arterijska bolezen;
- Addition of a warning on clinical trials which suggest that selective Cox-2 inhibitors may be
- dodano je svarilo v zvezi z kliničnimi preizkušanji, ki navaja, da so selektivni zaviralci Cox- 2
associated with a risk of thrombotic events (especially MI and stroke), relative to placebo and some NSAIDs.
(v primerjavi s placebom in nekaterimi nestereoidnimi protivnetnimi zdravili) lahko povezani z večjim tveganjem trombotičnih dogodkov, predvsem z miokardnim infarktom in možgansko kapjo kot placebo in nekateri NSAID;
hyperlipidaemia (high cholesterol levels), diabetes and smoking.
hiperlipidemija (visoke ravni holesterola), sladkorna bolezen in kajenje;