natgillin/translations-raw huggingface dataset:
The Cmax of the active metabolite is twice as high following a single 300-mg clopidogrel loading dose as it is after four days of 75-mg maintenance dose.
Cmax aktivnega presnovka je po enem 300-mg polnilnem odmerku klopidogrela dvakrat večja kot po štirih dneh uporabe vzdrževalnega odmerka 75 mg. Cmax je dosežena približno 30 do 60 minut po uporabi zdravila.
Blood and the lymphatic system disorders
Krvavitve in hematološke motnje
Slovenská republika Mylan sr.o
Ceská republika MylanPharmaceuticals s.r.o.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 75 mg klopidogrela v obliki klopidogrelijevega klorida.
Due to the risk of bleeding and haematologicaladverse reactions, blood cell count determination and/or other appropriate testing should be promptly considered whenever clinical symptoms suggestive of bleeding arise during the course of treatment (see section 4.8).
Če se med zdravljenjem pojavijo klinični simptomi, ki opozarjajo na možnost krvavitve, moramo zaradi tveganja pojava krvavitve in hematoloških neželenih učinkov pretehtati potrebo po določanju števila krvnih celic in/ali po drugih ustreznih preiskavah (glejte poglavje 4.8).
Boxes of 7, 14, 28, 56, 84 film-coated tablets in calendar blisters are available.
Na voljo so škatle s 7, 14, 28, 56 ali 84 filmsko obloženimi tabletami v koledarskem pretisnem omotu.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Musculo-skeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia
Bolezni mišičnoskeletneg a sistema in vezivnega tkiva mišično-skeletne krvavitve (hemartroza), artritis, artralgija, mialgija
• If you cut or injure yourself, it may take longer than usual for bleeding to stop.
• se lahko krvavitev ustavi počasneje kot ponavadi, če se urežete ali poškodujete.
• very common (affects more than 1 user in 10)
• zelo pogosti (pojavijo se pri več kot 1 od 10 uporabnikov)
Although the administration of clopidogrel 75 mg/day did not modify the pharmacokinetics of S-warfarin or International Normalised Ratio (INR) in patients receiving long-term warfarin therapy, coadministration of clopidogrel with warfarin increases the risk of bleeding because of independent
Uporaba 75 mg klopidogrela na dan ni spremenila farmakokinetike S-varfarina (substrata CYP2C9) ali internacionalnega normaliziranega razmerja (INR) pri bolnikih, ki so dolgotrajno prejemali varfarin.
While you are taking Clopidogrel Qualimed:
Ko jemljete zdravilo Klopidogrel Qualimed:
The plasma concentrations of the active metabolite was 20% reduced (loading dose) and 14% reduced (maintenance dose) during concomitant treatment with pantoprazole 80 mg once daily.
Pri sočasni uporabi 80 mg pantoprazola enkrat dnevno, so se zmanjšale plazemske koncentracije aktivnega presnovka za 20 % (začetni odmerek) in 14 % (vzdrževalni odmerek), z zmanjšanjem zavrtja agregacije trombocitov za 15 % in 11 %.
Apart from the specific medicinal product interaction information described above, interaction studies with clopidogrel and some medicinal products commonly administered in patients with atherothrombotic disease have not been performed.
Drugih študij o interakcijah klopidogrela z nekaterimi drugimi zdravili, ki jih bolniki z aterotrombotično boleznijo pogosto jemljejo, niso izvedli.
The decrease was associated with a 39% (loading dose) and 21% (maintenance dose) reduction of inhibition of platelet aggregation.
Povprečno zavrtje agregacije trombocitov se je zmanjšalo za 39 % (začetni odmerek) oz. 21 % (vzdrževalni odmerek).
In a randomised, double-blind, parallel-group study (CLARINET), 906 paediatric patients (neonates and infants) with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt were randomised to receive clopidogrel 0.2 mg/kg (n=467) or placebo (n=439) along with concomitant background therapy up to the time of second stage surgery.
Randomizirana dvojno slepa študija vzporednih skupin (CLARINET) je zajela 906 pediatričnih bolnikov (novorojenčkov in dojenčkov) s cianotično prirojeno srčno hibo, paliativno oskrbljeno s sistemsko-pljučnim arterijskim spojem (šantom).
Clopidogrel is a prodrug, one of whose metabolites is an inhibitor of platelet aggregation.
Klopidogrel je predzdravilo in eden njegovih presnovkov zavira agregacijo trombocitov.
Omeprazole 80 mg once daily administered either at the same time as clopidogrel or with 12 hours between the administrations of the two drugs decreased the exposure of the active metabolite by 45% (loading dose) and 40% (maintenance dose).
Če sta bila klopidogrel in omeprazol uporabljena skupaj istočasno ali v presledku 12 ur, se je izpostavljenost aktivnemu presnovku klopidogrela zmanjšala za 45 % (začetni odmerek) oz. 40 % (vzdrževalni odmerek).
Rash, pruritus, skin bleeding (purpura)
Bolezni kože in modrice izpuščaj, srbenje, kožne krvavitve (purpura)
Very rare erythema multiforme), angioedema, rash erythematous, urticaria, eczema, lichen planus
bulozni dermatitis (toksična epidermalna nekroliza, StevensJohnsonov sindrom, multiformni eritem), angioedem, eritematozni izpuščaj, urtikarija, ekcem, lihen planus
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
DOVOLJENJA ZA PROMET Z ZDRAVILOM Izdaja zdravila je le na recept.
In CLARITY, there was an overall increase in bleeding in the clopidogrel plus ASA group vs. the placebo plus ASA group.
V študiji CLARITY je v skupini bolnikov, ki so se zdravili s klopidogrelom in ASA, prišlo do splošnega povečanja krvavitev v primerjavi s skupino, ki je jemala placebo in ASA.
100 film-coated tablets: EU/1/09/559/009
100 filmsko obloženih tablet: EU/1/09/559/009
7 film-coated tablets - calendar blister 14 film-coated tablets - calendar blister 28 film-coated tablets - calendar blister
7 filmsko obloženih tablet - koledarski pretisni omot 14 filmsko obloženih tablet 14 filmsko obloženih tablet - koledarski pretisni omot 28 filmsko obloženih tablet 28 filmsko obloženih tablet - koledarski pretisni omot 30 filmsko obloženih tablet 30x1 filmsko obloženih tablet 50 filmsko obloženih tablet 50x1 filmsko obloženih tablet 56 filmsko obloženih tablet 56 filmsko obloženih tablet - koledarski pretisni omot 84 filmsko obloženih tablet 84 filmsko obloženih tablet - koledarski pretisni omot 90 filmsko obloženih tablet 100 filmsko obloženih tablet
Platelet aggregation induced by agonists other than ADP is also inhibited by blocking the amplification of
Zavrta je tudi agregacija trombocitov, ki jo izzovejo drugi agonisti kot ADP, ker pride do blokade ojačenja trombocitne aktivacije s sproščenim ADP.
Blister of OPA/Al/PVC-Al containing 7, 14, 28, 30, 50, 56, 84, 90 and 100 film-coated tablets in the box.
Na voljo so v pretisnih omotih (OPA/Al/PVC-Al) po 7, 14, 28, 30, 50, 56, 84, 90 in 100 filmsko obloženih tablet v škatli.
If you are breastfeeding or planning to breastfeed, talk to your doctor before taking this medicine.
Če dojite ali nameravate dojiti, se pred jemanjem tega zdravila posvetujte z zdravnikom.
Serum sickness, anaphylactoid reactions
Bolezni imunskega sistema serumska bolezen, anafilaktoidne reakcije
Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).
Ena filmsko obložena tableta vsebuje 75 mg klopidogrela v obliki klopidogrelijevega klorida.
EFFECTIVE USE OF THE MEDICINAL PRODUCT
FARMACEVTSKI PODATKI
Retroperitoneal haemorrhage
Peroralni antikoagulanti.
Consequently, NSAIDs including Cox-2 inhibitors and clopidogrel should be co-administered with caution (see section 4.4).
Zato moramo biti previdni pri sočasni uporabi nesteroidnih protivnetnih zdravil, vključno z zaviralci COX2 in klopidogrela (glejte poglavje 4.4).
A crossover study in 40 healthy subjects, 10 each in the four CYP2C19 metaboliser groups (ultrarapid, extensive, intermediate and poor), evaluated pharmacokinetic and antiplatelet responses using 300 mg followed by 75 mg/day and 600 mg followed by 150 mg/day, each for a total of 5 days (steady state).
Študija je ocenila farmakokinetiko in antiagregacijski odziv po uporabi odmerka 300 mg in potem 75 mg/dan ter 600 mg in potem 150 mg/dan, vsako od obeh shem skupaj 5 dni (stanje dinamičnega ravnovesja).
50x1 film-coated tablets EU/1/09/559/011
50x1 filmsko obloženih tablet: EU/1/09/559/011
Boxes of 7, 14, 28, 30, 50, 56, 84, 90 and 100 film-coated tablets in blisters are available.
Na voljo so v pretisnih omotih po 7, 13, 28, 30, 50, 56, 84, 90 in 100 filmsko obloženih tablet v škatli.
• common (affects 1 to 10 users in 100)
• pogosti (pojavijo se pri 1 do 10 od 100 uporabnikov)
Fertility Clopidogrel was not shown to alter fertility in animal studies.
Plodnost Šudije na živalih niso pokazale, da bi klopidogrel vplival na plodnost.
30x1 film-coated tablets EU/1/09/559/010
30x1 filmsko obloženih tablet: EU/1/09/559/010
• Hepatic impairment
• Pediatrična populacija
A. THE MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
A. IMETNIKI DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNI ZA SPROŠČANJE SERIJE
• rare (affects 1 to 10 users in 10,000)
• redki (pojavijo se pri 1 do 10 od 10.000 uporabnikov)
Therefore clopidogrel should be used with caution in these patients (see section 4.2).
Zaradi pomanjkanja izkušenj pri zdravljenju bolnikov z ledvično okvaro klopidogrel tem bolnikom dajemo previdno (glejte poglavje 4.2).
Neutropenia, including severe neutropenia
Ušesne bolezni, vključno z motnjami labirinta vrtoglavica
If you forget to take a dose of Clopidogrel Qualimed, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Če ste pozabili vzeti zdravilo Klopidogrel Qualimed Če ste pozabili vzeti odmerek in od tega ni minilo več kot 12 ur, ga vzemite takoj, ko se spomnite.
Contact your doctor or the nearest hospital emergency department because of the increased risk of
Če ste vzeli večji odmerek zdravila Klopidogrel Qualimed, kot bi smeli Zaradi povečanega tveganja za krvavitev se posvetujte s svojim zdravnikom ali z medicinskim osebjem na najbližjem oddelku za nujno zdravniško pomoč.
CALENDAR BLISTER (boxes of 7, 14, 28, 56 or 84 tablets)
KOLEDARSKI PRETISNI OMOT ŠKATLE Z DNE 7, 14, 28, 56, IN 84
Other medicinal products: A number of other clinical studies have been conducted with clopidogrel and other concomitant medicinal products to investigate the potential for pharmacodynamic and pharmacokinetic interactions.
Da bi proučili možnosti za farmakodinamične in farmakokinetične interakcije, so številne klinične študije izvedli tudi z drugimi zdravili.
Patients should inform physicians and dentists that they are taking clopidogrel before any surgery is scheduled and before any new medicinal product is taken.
Pred vsakim načrtovanim kirurškim posegom in preden vzamejo katerokoli novo zdravilo, morajo bolniki zdravnika in zobozdravnika obvestiti, da jemljejo klopidogrel.
- heparin, or any other injectable medicine used to reduce blood clotting, -omeprazole, esomeprazole or cimetidine, medicines to treat for upset stomach,
• omeprazol, esomeprazol ali cimetidin, zdravila za zdravljenje težav z želodcem,
Week 2 (for boxes of 14, 28, 56, 84)
Teden 2 (samo za škatle z 14, 28, 56 in 84 tabletami) Teden 3 (samo za škatle z 28, 56 in 84 tabletami) Teden 4 (samo za škatle z 28, 56 in 84 tabletami)
Therefore, concomitant use should be undertaken with caution (see section 4.4).
Zaradi previdnosti se je treba izogniti sočasni uporabi omeprazola ali esomeprazola (glejte poglavje 4.4).
No clinically significant pharmacodynamic interactions were observed when clopidogrel was co-administered with atenolol, nifedipine, or both atenolol and nifedipine.
Pri sočasnem jemanju klopidogrela ter atenolola in nifedipina ali obeh niso opazili nobenih klinično pomembnih farmakodinamičnih interakcij.
- a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer) - a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
• če pri vas obstaja tveganje za krvavitev, kot je: - zdravstveno stanje s tveganjem za notranjo krvavitev (rana na želodcu), - krvna motnja, zaradi katere ste bolj nagnjeni k notranji krvavitvi (krvavitev v tkivih, organih ali sklepih vašega telesa), - nedavna huda poškodba, - nedavni kirurški poseg (tudi na zobeh), - načrtovan kirurški poseg (tudi na zobeh) v naslednjih sedmih dneh;
System Organ Class
Sistem farmakovigilance
• Severe hepatic impairment.
• Huda jetrna okvara.
A. THE MANUFACTURING AUTHORISATION HOLDER(S)
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
• uncommon (affects 1 to 10 users in 1,000)
• občasni (pojavijo se pri 1 do 10 od 1.000 uporabnikov)
- fluoxetine, fluvoxamine, or moclobemide, medicines to treat depression, - carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy, - ticlopidine, other antiplatelet agent.
• karbamazepin ali oksakarbazepin, zdravila za zdravljenje nekaterih oblik epilepsije,
Breastfeeding
propilenglikol
6.3 Shelf life 2 years.
6.3 Rok uporabnosti
- signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 ‘Take special care with Clopidogrel Qualimed').
Nemudoma se posvetujte s svojim zdravnikom, če se pri vas pojavijo: - zvišana telesna temperatura, znaki okužbe ali huda utrujenost, kar so znaki redkega zmanjšanja števila določenih krvnih celic; - znaki jetrnih težav, npr. porumenelost kože in/ali oči (zlatenica), ki so lahko povezani s krvavitvijo, ki se pojavi pod kožo kot drobne rdeče pike, in/ali zmedenostjo (glejte poglavje 2 »Bodite posebno pozorni pri jemanju zdravila Klopidogrel Qualimed«); - otekanje ust ali bolezni kože, kot so izpuščaj, srbenje in mehurji na koži kar so lahko znaki alergijske reakcije.
Clopidogrel Qualimed is taken to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as
Klopidogrel Qualimed se jemlje za preprečevanje nastanka krvnih strdkov (trombov) v otrdelih krvnih žilah (arterijah).
The safety and efficacy of clopidogrel have been evaluated in 4 double-blind studies involving over 80,000 patients: the CAPRIE study, a comparison of clopidogrel to ASA, and the CURE, CLARITY and COMMIT studies comparing clopidogrel to placebo, both medicinal products given in combination with ASA and other standard therapy.
CURE, CLARITY in COMMIT pa klopidogrel in placebo; bolniki so oboje dobivali v kombinaciji z ASA in drugo standardno terapijo.
Clopidogrel is first metabolised to a 2-oxo-clopidogrel intermediate metabolite.
Klopidogrel se najprej presnovi v 2-oksoklopidogrel, ki je vmesen presnovek.
Common side effects: Diarrhoea, abdominal pain, indigestion or heartburn.
Pogosti neželeni učinki: driska, bolečina v trebuhu, slaba prebava ali zgaga.
As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel Qualimed.
Iz varnostnih razlogov naj matere, ki se zdravijo z zdravilom Klopidogrel dura, ne dojijo.
Thrombocytopenia , leucopenia, eosinophilia
huda trombocitopenija, granulocitopenija, anemija
No substantial differences in active metabolite exposure and mean inhibition of platelet aggregation
Med ultrahitrimi, dobrimi in srednjimi metabolizatorji niso ugotovili bistvenih razlik v izpostavljenosti aktivnemu presnovku in povprečnem zavrtju agregacije trombocitov (IPA).
If you forget to take Clopidogrel Qualimed:
Ne jemljite zdravila Klopidogrel Qualimed:
Common
Sre
A pharmacodynamic interaction between clopidogrel and heparin is possible, leading to increased risk of bleeding.
Vendar pa sočasna uporaba klopidogrela in varfarina poveča tveganje krvavitev zaradi neodvisnih vplivov na hemostazo.
WHAT CLOPIDOGREL QUALIMED IS AND WHAT IT IS USED FOR Clopidogrel Qualimed belongs to a group of medicines called antiplatelet medicinal products.
Klopidogrel Qualimed spada v skupino zdravil, ki se imenujejo zaviralci agregacije trombocitov.
Before you take Clopidogrel Qualimed
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO KLOPIDOGREL QUALIMED
Always take Clopidogrel Qualimed exactly as your doctor has told you.
Pri jemanju zdravila Klopidogrel Qualimed natančno upoštevajte zdravnikova navodila.
Method of administration For oral use
Za peroralno uporabo
This leaflet was last approved in MM/YYYY.
Navodilo je bilo odobreno {MM/LLLL}
What Clopidogrel Qualimed contains
KAKO JEMATI ZDRAVILO KLOPIDOGREL QUALIMED
Repeated doses of 75 mg per day produced substantial inhibition of ADP-induced platelet aggregation from the first day; this increased progressively and reached steady state between Day 3 and Day 7.
Večkratni odmerki po 75 mg na dan od prvega dne pomembno zavirajo agregacijo trombocitov, ki jo je sprožil ADP.
The most common side effect is bleeding.
Najpogostejši neželeni učinek o katerem so poročali med zdravljenjem z zdravilom Klopidogrel Qualimed je krvavitev.
Usually treatment is short-term.
Ponavadi je zdravljenje kratkoročno.
Date of first authorisation: 15 June 2017
Datum prve odobritve: 15. junij 2017
H-2900 Komárom Hungary
H-2900 Komárom Madžarska
APEX (28 weeks)
APEX (28 tednov)
FACT (52 weeks)
FACT (52 tednov)
• ringing in the ears
• zvenenje v ušesih,
• muscle damage, a condition which on rare occasions can be serious.
• okvara mišic, stanje, ki je lahko v redkih primerih resno.
Your doctor may ask you to have blood tests to check that your liver is working normally.
Zdravnik vas bo morda napotil na krvne preiskave, da preveri, ali vaša jetra normalno delujejo.
Table 2 summarises the primary efficacy endpoint results:
V preglednici 2 so povzeti izidi primarnih opazovanih dogodkov učinkovitosti:
The potential risk for human is unknown.
Možno tveganje za ljudi ni znano.
A risk to a suckling infant cannot be excluded.
Tveganja za dojenega otroka ni mogoče izključiti.
117 Allee des Parcs 69 800 Saint Priest France
117 Allee des Parcs 69 800 Saint Priest Francija
Your doctor will have prescribed the strength most suitable for you.
Vaš zdravnik vam bo predpisal za vas ustrezno jakost.
Combined Results
Združeni rezultati
Do not give this medicine to children under the age of 18 because the safety and efficacy have not been established.
Zdravila ne dajajte otrokom, starim manj kot 18 let, saj varnost in učinkovitost nista bili dokazani.
• difficulty in sleeping, sleepiness
• težave s spanjem, zaspanost,
Other side effects which are not mentioned above are listed below.
Ostali neželeni učinki, ki niso omenjeni zgoraj, so našteti spodaj.
Also contains lactose.
Vsebuje tudi laktozo.
Do not use this medicine after the expiry date which is stated on the packaging after ‘EXP.'
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake ''EXP:''.
In most cases, these reactions occurred during the first month of therapy with febuxostat.
V večini primerov so se te reakcije pojavile v prvih mesecih zdravljenja s febuksostatom.
Four pharmacologically active hydroxyl metabolites have been identified, of which three occur in plasma of humans.
Identificirali so štiri farmakološko aktivne hidroksilirane presnovke, od katerih se trije pojavljajo v plazmi pri ljudeh.
• If you are allergic to febuxostat or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na febuksostat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Overall 56.6% of patients discontinued trial treatment prematurely and 45% of patients did not complete all trial visits.
Skupno je preskušanje predčasno prekinilo 56,6% bolnikov, 45% bolnikov pa ni opravilo vseh obiskov v okviru preskušanja.
• urgent need to urinate
• nujna potreba po odvajanju urina,
Not everyone gets flares, but you could get a flare-up even if you are taking Febuxostat Mylan, and especially during the first weeks or months of treatment.
Do izbruha ne pride pri vseh ljudeh, vendar se lahko pojavi tudi, če jemljete zdravilo Febuksostat Mylan, še zlasti v prvih tednih ali mesecih zdravljenja.
Prophylaxis against gout flares was obligatory over the 26-week period.
Preventivno zdravljeneje zagonov putike je bilo obvezno v času 26-ih tednov.
Your doctor will often prescribe other medicines, if they are needed, to help prevent or treat the symptoms of flares (such as pain and swelling in a joint).
Vaš zdravnik vam bo pogosto predpisal druga zdravila, če bodo potrebna za preprečevanje ali zdravljenje simptomov izbruhov protina (kot so bolečine in oteklost sklepov).
The efficacy and safety of febuxostat in the prevention and treatment of Tumor Lysis Syndrome was evaluated in the FLORENCE (FLO-01) study.
Učinkovitost in varnost febuksostata pri preventivi in zdravljenju sindroma tumorske lize sta bili ocenjeni v študiji FLORENCE (FLO-01).
Long-term, open label extension Studies
Dolgotrajne, odprte podaljšane raziskave
Stop taking this medicine and contact your doctor immediately or go to an emergency department nearby if the following rare (may affect up to 1 in 1,000 people) side effects occur, because a serious allergic reaction might follow:
Prenehajte jemati zdravilo in nemudoma pokličite svojega zdravnika ali pojdite na oddelek za nujno medicinsko pomoč najbližje bolnišnice, če se pojavijo naslednji redki (pojavijo se pri 1 od 1.000 bolnikov) neželeni učinki, saj jim lahko sledijo resne alergijske reakcije:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
The majority of adverse reactions were either mild or moderate.
Večina neželenih učinkov je bilo bodisi milih ali zmernih.
Over time, gout flares will occur less often and be less painful if you keep taking Febuxostat Mylan every day.
Čez čas se bodo izbruhi protina pojavljali manj pogosto in bodo manj boleči, če boste nadaljevali z jemanjem zdravila Febuksostat Mylan vsak dan.
Febuxostat is rapidly (tmax of 1.0-1.5 h) and well absorbed (at least 84%).
Febuksostat se hitro (tmax 1,0-1,5 h) in dobro absorbira (vsaj 84 %).
Medicinal products that inhibit glucuronidation, such as NSAIDs and probenecid, could in theory affect the elimination of febuxostat.
Zdravila, ki zavirajo glukuronidacijo, kot so NSAID in probenecid, lahko zato teoretično vplivajo na izločanje febuksostata.
The rash may progress to widespread blistering or peeling of the skin.
Izpuščaj se lahko razvije v razširjeno mehurjenje ali luščenje kože.
Post Marketing long term studies
Dolgoročne študije iz obdobja trženja
• abnormally low blood cell counts (white or red blood cells or platelets)
• nenormalno majhno število krvnih celic (belih ali rdečih celic ali krvnih ploščic),
Your doctor might decide to permanently stop treatment with Febuxostat Mylan.
Vaš zdravnik se lahko odloči, da za stalno prekine zdravljenje z zdravilom Febuksostat Mylan.
These findings are considered a consequence of species specific purine metabolism and urine composition and of no relevance to clinical use.
Ti dogodki so posledica vrstno značilne presnove purina in sestave urina in nimajo pomena za klinično uporabo.
The frequencies are based on studies and post-marketing experience in gout patients.
Pogostnost temelji na študijah in izkušnjah v obdobju trženja pri bolnikih s protinom.
Febuxostat treatment should not be started until an acute attack of gout has completely subsided.
Zdravljenje s febuksostatom se ne sme začeti, dokler se akutni zagon protina popolnoma ne izboljša.
• anaphylactic reactions, drug hypersensitivity (see also section 2 “Warnings and precautions”)
• anafilaktične reakcije, preobčutljivost na zdravilo (glejte tudi poglavje »Opozorila in previdnostni ukrepi”)