natgillin/translations-raw huggingface dataset:
The efficacy of clopidogrel was observed independently of the dose of ASA (75-325 mg once daily).
Učinkovitost klopidogrela so opazili neodvisno od odmerka ASA (75- 325 mg enkrat na dan).
The CLARITY trial included 3,491 patients presenting within 12 hours of the onset of a ST elevation MI and planned for thrombolytic therapy.
V študijo CLARITY je bilo vključenih 3. 491 bolnikov v 12 urah po nastopu akutnega miokardnega infarkta z elevacijo ST spojnice, ki so bili predvideni za trombolitično terapijo.
Patients received clopidogrel (300 mg loading dose, followed by 75 mg/ day, n=1,752) or placebo (n=1,739), both in combination with ASA (150 to 325 mg as a loading dose, followed by 75 to 162 mg/ day), a fibrinolytic agent and, when appropriate, heparin.
Bolniki so dobivali klopidogrel (300 mg udarni odmerek, nato pa 75 mg na dan, n=1. 752) ali placebo (n=1. 739), oboje v kombinaciji z ASA (150 mg do 325 mg kot udarni odmerek, nato 75 mg do 162 mg na dan), fibrinolitičnim sredstvom in po potrebi heparinom.
The patient population included 19.7% women and 29.2% patients ≥ 65 years.
Populacijo bolnikov je sestavljalo 19, 7% žensk in 29, 2% bolnikov v starosti ≥ 65 let.
A total of 99.7% of patients received fibrinolytics (fibrin specific:
Skupno 99, 7% bolnikov je dobivalo fibrinolitike (fibrinsko specifične:
68.7%, non-fibrin specific:
68, 7%, nefebrinsko specifične:
31.1%), 89.5% heparin, 78.7% beta blockers, 54.7% ACE inhibitors and 63% statins.
31, 1%), 89, 5% heparin, 78, 7% zaviralce adrenergičnih receptorjev beta, 54, 7% zaviralce ACE in 63% statine.
24, 47%; p < 0.001), mainly related to a reduction in occluded infarct-related arteries.
Primarni opazovani dogodek je bil opažen pri 15, 0% bolnikov v skupini s klopidogrelom in 21¸7% bolnikov v skupini s placebom, kar predstavlja absolutno zmanjšanje za 6, 7% in 36% zmanjšanje verjetnosti v prid klopidogrela (95% IZ od 24% do 47%; p < 0, 001) v glavnem zaradi zmanjšanja zaradi infarkta zamašenih arterij.
This benefit was consistent across all prespecified subgroups including patients’ age and gender, infarct location, and type of fibrinolytic or heparin used.
Ta koristni učinek se je pojavljal v vseh prehodno opredeljenih 9 podskupinah glede na bolnikovo starost ali spol, mesto infarkta in tip uporabljenega fibrinolitika ali heparina.
ST elevation, ST depression or left bundle-branch block).
V študijo COMMIT z 2x2 faktorsko raziskovalno zasnovo je bilo vključenih 45. 852 bolnikov v 24 urah po nastopu simptomov, ki bi lahko kazali na miokardni infarkt, z neustreznimi vrednostmi EKG, ki so to potrjevale (elevacija ST spojnice, depresija ST spojnice ali levokračni blok).
Patients received clopidogrel (75 mg/ day, n=22,961) or placebo (n=22,891), in combination with ASA (162 mg/ day), for 28 days or until hospital discharge.
Bolniki so 28 dni oziroma do odpusta dobivali klopidogrel (75 mg na dan, n=22. 961) ali placebo (n=22. 891) v kombinaciji z ASA (162 mg na dan).
The population included 27.8% women, 58.4% patients ≥ 60 years (26% ≥ 70 years) and 54.5% patients who received fibrinolytics.
Populacijo bolnikov je sestavljalo 27, 8% žensk, 58, 4% bolnikov starost ≥ 60 let (26% ≥ 70 let) in 54, 5% bolnikov, ki so dobivali fibrinolitike.
Clopidogrel significantly reduced the relative risk of death from any cause by 7% (p = 0.029), and the relative risk of the combination of re-infarction, stroke or death by 9% (p = 0.002), representing an absolute reduction of 0.5% and 0.9%, respectively.
Klopidogrel je pomembno zmanjšal relativno tveganje za smrt zaradi kateregakoli vzroka za 7% (p=0, 029) in relativno tveganje za ponovni infarkt, kap ali smrt za 9% (p=0, 002), kar je predstavljalo absolutno zmanjšanje za 0, 5% oziroma 0, 9%.
However, plasma concentrations of the parent compound are very low and below the quantification limit (0.00025 mg/ l) beyond 2 hours.
5. 2 Farmakokinetične lastnosti
Absorption is at least 50%, based on urinary excretion of clopidogrel metabolites.
Absorpcija je najmanj 50%, na podlagi metabolitov klopidrogela, izločenih z urinom.
Clopidogrel is extensively metabolised by the liver and the main metabolite, which is inactive, is the carboxylic acid derivative, which represents about 85% of the circulating compound in plasma.
Klopidogrel se obsežno presnavlja v jetrih, glavni metabolit, ki je neučinkovit, je derivat karboksilne kisline in predstavlja približno 85% v plazmi krožeče spojine.
Peak plasma levels of this metabolite (approx.
Najvišja plazemska raven tega metabolita (pribl.
3mg/ l after repeated 75 mg oral doses) occurred approximately 1 hour after dosing.
3 mg/ l po večkratnih 75 mg peroralnih odmerkih) se je pojavila približno 1 uro po odmerjanju.
Clopidogrel is a prodrug.
Klopidogrel je predzdravilo.
The active metabolite, a thiol derivative, is formed by oxidation of clopidogrel to 2-oxo-clopidogrel and subsequent hydrolysis.
Aktivni metabolit, derivat tiola, se tvori z oksidacijo klopidogrela v 2 - okso- klopidogrel in kasnejšo hidrolizo.
The oxidative step is regulated primarily by Cytochrome P450 isoenzymes 2B6 and 3A4 and to a lesser extent by 1A1, 1A2 and 2C19.
Fazo oksidacije primarno regulirata izoencima citokroma P450 2B6 in 3A4, v manjši meri tudi 1A1, 1A2 in 2C19.
The active thiol metabolite, which has been isolated in vitro, binds rapidly and irreversibly to platelet receptors, thus inhibiting platelet aggregation.
Učinkoviti tiolov metabolit, ki so ga izolirali in vitro, se hitro in ireverzibilno veže na trombocitne receptorje ter tako zavira agregacijo trombocitov.
This metabolite has not been detected in plasma.
Tega metabolita niso določili v plazmi.
The kinetics of the main circulating metabolite were linear (plasma concentrations increased in proportion to dose) in the dose range of 50 to 150 mg of clopidogrel.
Kinetika glavnega krožečega metabolita je bila linearna (plazemske koncentracije so se povišale sorazmerno z odmerkom) v razponu odmerkov 50 do 150 mg klopidogrela.
Clopidogrel and the main circulating metabolite bind reversibly in vitro to human plasma proteins (98% and 94% respectively).
Klopidogrel in glavni krožeči metabolit se in vitro reverzibilno vežeta na humane plazemske proteine (98% oziroma 94%).
Following an oral dose of 14C-labelled clopidogrel in man, approximately 50% was excreted in the urine and approximately 46% in the faeces in the 120-hour interval after dosing.
Po peroralnem odmerku s 14C- označenega klopidogrela pri človeku, se ga je približno 50% izločilo z urinom in približno 46% z blatom v 120 urnem intervalu po odmerjanju.
The elimination half- life of the main circulating metabolite was 8 hours after single and repeated administration.
Razpolovni čas izločanja glavnega krožečega metabolita je bil 8 ur po enkratnem in večkratnem dajanju.
After repeated doses of 75 mg clopidogrel per day, plasma levels of the main circulating metabolite were lower in subjects with severe renal disease (creatinine clearance from 5 to 15 ml/ min) compared to subjects with moderate renal disease (creatinine clearance from 30 to 60 ml/ min) and to levels observed in other studies with healthy subjects.
Po večkratnih odmerkih 75 mg klopidogrela na dan, je bila plazemska raven glavnega krožečega metabolita nižja pri osebah s hudo ledvično boleznijo (očistek kreatinina 5 do 15 ml/ min) v primerjavi z osebami z zmerno ledvično boleznijo (očistek kreatinina 30 do 60 ml/ min) in v primerjavi z ravnmi, opaženimi v drugih študijah z zdravimi osebami.
Although inhibition of ADP-induced platelet aggregation was lower (25%) than that observed in healthy subjects, the prolongation of bleeding was similar to that seen in healthy subjects receiving 75 mg of clopidogrel per day.
Čeprav je bila inhibicija z ADP sprožene agregacije trombocitov manjša (25%) od tiste, opažene pri zdravih osebah, je bilo podaljšanje krvavitve podobno tistemu, ki so ga opazili pri zdravih osebah, ki so prejemale 75 mg klopidogrela na dan.
The pharmacokinetics and pharmacodynamics of clopidogrel were assessed in a single and multiple dose study in both healthy subjects and those with cirrhosis (Child-Pugh class A or B).
Farmakokinetika in farmakodinamika klopidogrela sta bili ocenjeni v študiji enkratnega in večkratnega odmerka tako pri zdravih osebah kot pri tistih s cirozo (Child- Pugh klasifikacija A ali B).
Daily dosing for 10 days with clopidogrel 75 mg/ day was safe and well tolerated.
Dnevno odmerjanje 75 mg/ dan, 10 dni, je bilo varno in so ga bolniki dobro prenašali.
Clopidogrel Cmax for both single dose and steady state for cirrhotics was many fold higher than in normal subjects.
Cmax klopidogrela, tako pri enkratnem odmerku kot v stanju dinamičnega ravnovesja pri bolnikih s cirozo, je bila nekajkrat višja kot pri zdravih osebah.
However, plasma levels of the main circulating metabolite together with the effect of clopidogrel on ADP-induced platelet aggregation and bleeding time were comparable between these groups.
10 metabolita skupaj z učinkom klopidogrela na z ADP sproženo agregacijo trombocitov in čas krvavitve primerljiva med obema skupinama.
10 5.3 Preclinical safety data
5. 3 Predklinični podatki o varnosti
These occurred at doses representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/ day and were a consequence of an effect on hepatic metabolising enzymes.
Pojavile so se pri odmerkih, ki predstavljajo najmanj 25- kratno izpostavljenost kot pri človeku ob prejemanju kliničnega odmerka 75 mg/ dan in so bile posledica učinka na jetrne presnovne encime.
At very high doses, a poor gastric tolerability (gastritis, gastric erosions and/ or vomiting) of clopidogrel was also reported in rat and baboon.
Pri zelo visokih odmerkih so pri podganah in pavijanih poročali tudi o slabem želodčnem prenašanju (gastritis, želodčne erozije in/ ali bruhanje).
There was no evidence of carcinogenic effect when clopidogrel was administered for 78 weeks to mice and 104 weeks to rats when given at doses up to 77 mg/ kg per day (representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/ day).
Ni bilo dokazov o kancerogenem učinku pri dajanju klopidogrela mišim 78 tednov in podganam 104 tedne v odmerkih do 77 mg/ kg na dan (kar predstavlja najmanj 25- krat višjo izpostavljenost kot pri človeku ob prejemanju kliničnega odmerka 75 mg/ dan).
Mannitol (E421) Macrogol 6000 Microcrystalline cellulose Hydrogenated castor oil Low substituted hydroxypropylcellulose
Jedro: manitol (E421) makrogol 6000 mikrokristalna celuloza hidrogenirano ricinusovo olje nizko substituirana hidroksipropilceluloza
Hypromellose (E464) Lactose Triacetin (E1518) Titanium dioxide (E171) Red iron oxide (E172) Carnauba wax
Obloga: hipromeloza (E464) laktoza triacetin (E1518) titanov dioksid (E171) rdeči železov oksid (E172) karnauba vosek.
In PVC/ PVDC/ aluminium blisters, store below 30°C.
V PVC/ PVDC/ alu pretisnih omotih shranjujte pri temperaturi do 30°C.
11 6.5 Nature and content of container
11 Za shranjevanje zdravila v aluminijastih pretisnih omotih niso potrebna posebna navodila.
PVC/ PVDC/ Aluminium blisters or all aluminium blisters in cardboard cartons containing 7, 14, 28, 30, 84, 90 and 100 film-coated tablets.
PVC/ PVDC/ aluminijasti pretisni omoti ali pretisni omoti iz aluminija, ki vsebujejo 7, 14, 28, 30, 84, 90 in 100 filmsko obloženih tablet.
PVC/ PVDC/ Aluminium or all aluminium perforated unit-dose blister packs in cardboard cartons containing 50x1 film-coated tablets.
PVC/ PVDC/ aluminijast ali aluminijast perforirani pretisni omot za enkratni odmerek v kartonskih škatlah, ki vsebujejo 50x1 filmsko obloženo tableto.
Bristol Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom
Bristol- Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH Velika Britanija
EU/ 1/ 08/ 464/ 001 - Cartons of 14 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 464/ 002 - Cartons of 14 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 464/ 003 - Cartons of 28 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 464/ 004 - Cartons of 28 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 464/ 005 - Cartons of 30 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 464/ 006 - Cartons of 30 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 464/ 007 - Cartons of 50x1 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 464/ 008 - Cartons of 50x1 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 464/ 009 - Cartons of 84 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 464/ 010 - Cartons of 84 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 464/ 011 - Cartons of 90 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 464/ 012 - Cartons of 90 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 464/ 013 - Cartons of 100 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 464/ 014 - Cartons of 100 film-coated tablets in all aluminium blisters EU/ 1/ 08/ 464/ 018 - Cartons of 7 film-coated tablets in PVC/ PVDC/ Alu blisters EU/ 1/ 08/ 464/ 019 - Cartons of 7 film-coated tablets in all aluminium blisters
EU/ 1/ 08/ 464/ 001 - škatle s 14 filmsko obloženimi tabletami v PVC/ PVDC/ alu pretisnih omotih EU/ 1/ 08/ 464/ 002 - škatle s 14 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/ 1/ 08/ 464/ 003 - škatle z 28 filmsko obloženimi tabletami v PVC/ PVDC/ alu pretisnih omotih EU/ 1/ 08/ 464/ 004 - škatle z 28 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/ 1/ 08/ 464/ 005 - škatle s 30 filmsko obloženimi tabletami v PVC/ PVDC/ alu pretisnih omotih EU/ 1/ 08/ 464/ 006 - škatle s 30 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/ 1/ 08/ 464/ 007 - škatle s 50x1 filmsko obloženimi tabletami v PVC/ PVDC/ alu pretisnih omotih EU/ 1/ 08/ 464/ 008 - škatle s 50x1 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/ 1/ 08/ 464/ 009 - škatle z 84 filmsko obloženimi tabletami v PVC/ PVDC/ alu pretisnih omotih EU/ 1/ 08/ 464/ 010 - škatle z 84 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/ 1/ 08/ 464/ 011 - škatle z 90 filmsko obloženimi tabletami v PVC/ PVDC/ alu pretisnih omotih EU/ 1/ 08/ 464/ 012 - škatle z 90 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/ 1/ 08/ 464/ 013 - škatle s 100 filmsko obloženimi tabletami v PVC/ PVDC/ alu pretisnih omotih EU/ 1/ 08/ 464/ 014 - škatle s 100 filmsko obloženimi tabletam v aluminijastih pretisnih omotih EU/ 1/ 08/ 464/ 018 - škatle s 7 filmsko obloženimi tabletami v PVC/ PVDC/ alu pretisnih omotih EU/ 1/ 08/ 464/ 019 - škatle s 7 filmsko obloženimi tabletami v aluminijastih pretisnih omotih
Detailed information on this product is available on the website of the European Medicines Agency (EMEA): http: / /www. emea. europa. eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http: // www. emea. europa. eu /.
Excipients: each tablet contains 12 mg lactose and 13.2 mg hydrogenated castor oil.
Pomožne snovi: ena tableta vsebuje 12 mg laktoze in 13, 2 mg hidrogeniranega ricinusovega olja.
Pink, oblong, engraved with « 300 » on one side and « 1332 » on the other side.
Rožnate, podolgovate tablete z vtisnjeno številko "300" na eni strani in "1332" na drugi strani.
Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).
akutni koronarni sindrom brez elevacije ST spojnice (nestabilna angina ali miokardni infarkt brez Q zobca), vključno z bolniki, katerim je bil vstavljen stent po perkutani koronarni intervenciji, v kombinaciji z acetilsalicilno kislino (ASA – Acetylsalicylic acid).
This 300 mg tablet of clopidogrel is intended for use as a loading dose in patients suffering from acute coronary syndrome: − Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction): clopidogrel treatment should be initiated with a single 300 mg loading dose and then continued at 75 mg once a day (with acetylsalicylic acid (ASA) 75 mg-325 mg daily).
Akutni koronarni sindrom brez elevacije ST spojnice (nestabilna angina ali miokardni infarkt brez Q zobca): zdravljenje moramo začeti z enkratnim udarnim odmerkom 300 mg klopidogrela in nadaljevati s 75 mg enkrat na dan (s 75 mg do 325 mg acetilsalicilne kisline (ASA) dnevno).
Combined therapy should be started as early
S kombiniranim zdravljenjem je potrebno začeti čim prej po nastopu simptomov in z njim
13
13 nadaljevati vsaj štiri tedne.
• Hypersensitivity to the active substance or to any of the excipients. • Severe liver impairment. • Active pathological bleeding such as peptic ulcer or intracranial haemorrhage.
• preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov • huda jetrna okvara • aktivna patološka krvavitev, kot je peptična razjeda ali intrakranialna krvavitev
Due to the risk of bleeding and haematological undesirable effects, 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).
Zaradi tveganja krvavitve in hematoloških neželenih učinkov moramo takoj pretehtati potrebo po določanju števila krvnih celic in/ ali drugih ustreznih preiskav, kadarkoli se v času zdravljenja pojavijo klinični simptomi, ki nakazujejo krvavitev (glejte poglavje 4. 8).
As with other antiplatelet agents, clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions and in patients receiving treatment with ASA, heparin, glycoprotein IIb/IIIa inhibitors, or non-steroidal anti-inflammatory drugs including Cox-2 inhibitors.
Kot pri drugih antitrombotikih, moramo klopidogrel uporabljati previdno pri bolnikih s tveganjem za povečano krvavitev zaradi poškodbe, kirurškega posega ali drugih patoloških stanj in pri bolnikih, ki so na zdravljenju z ASA, heparinom, zaviralci glikoproteina IIb/ IIIa ali nesteroidnimi protivnetnimi zdravili, vključno z zaviralci COX- 2.
Patients should be followed carefully for any signs of bleeding including occult bleeding, especially during the first weeks of treatment and/or after invasive cardiac procedures or surgery.
Bolnike morate skrbno spremljati zaradi znakov krvavitve, vključno z okultno krvavitvijo, zlasti prve tedne zdravljenja in/ ali po invazivnih kardioloških postopkih ali kirurških posegih.
14 Experience is limited in patients with moderate hepatic disease who may have bleeding diatheses.
14 Izkušnje so omejene pri bolnikih z zmerno jetrno boleznijo, ki imajo lahko hemoragično diatezo.
Glycoprotein IIb/IIIa inhibitors: clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions that receive concomitant glycoprotein IIb/IIIa inhibitors (see section 4.4).
Zaviralci glikoproteina IIb/ IIIa: klopidogrel moramo uporabljati previdno pri bolnikih, ki imajo lahko tveganje za povečano krvavitev zaradi poškodbe, kirurškega posega ali drugih patoloških stanj, ko prejemajo sočasno zaviralce glikoproteina IIb/ IIIa (glejte poglavje 4. 4).
Data from the CAPRIE study indicate that phenytoin and tolbutamide can be safely co-administered with clopidogrel.
15 Podatki študije CAPRIE kažejo, da se lahko fenitoin in tolbutamid sočasno s klopidogrelom varno uporabljata.
However, patients entered into clinical trials with clopidogrel received a variety of concomitant medicinal products including diuretics, beta blockers, ACEI, calcium antagonists, cholesterol lowering agents, coronary vasodilators, antidiabetic agents (including insulin), antiepileptic agents and GPIIb/IIIa antagonists without evidence of clinically significant adverse interactions.
Vendar pa so bolniki, ki so bili vključeni v klinično preskušanje klopidogrela, prejemali sočasno različna zdravila, vključno z diuretiki, zaviralci adrenergičnih receptorjev beta, zaviralci angiotenzinske konvertaze (ACEI), kalcijevimi antagonisti, učinkovinami za zniževanje holesterola, koronarnimi vazodilatatorji, antidiabetiki (vključno z insulinom), antiepileptičnimi učinkovinami in antagonisti glikoproteina IIb/ IIIa, brez dokazov o klinično pomembnih neželenih interakcijah.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih vplivov na nosečnost, razvoj zarodka/ plodu, porod ali postnatalni razvoj (glejte poglavje 5. 3).
Overall, clopidogrel 75 mg/day was comparable to ASA 325 mg/day in CAPRIE regardless of age, gender and race.
V celoti je bil klopidogrel v odmerku 75 mg/ dan v študiji CAPRIE, primerljiv z ASA v odmerku 325 mg/ dan, ne glede na starost, spol ali raso.
This was
Incidenca večjih krvavitev je bila v obeh skupinah podobna (1, 3% v skupini s klopidogrelom in ASA ter 1, 1% v skupini s placebom in ASA).
16 consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy.
To je veljalo tudi za podskupine bolnikov, opredeljene z določenimi izhodiščnimi značilnostmi in tipom fibrinolitičnega ali heparinskega zdravljenja.
Their frequency is defined using the following conventions: common (≥1/100 to < 1/10); uncommon (≥1/1,000 to < 1/100); rare (≥1/10,000 to < 1/1,000); very rare (< 1/10,000).
Njihova pogostnost je navedena upoštevaje naslednji dogovor: pogosti (≥ 1/ 100, < 1/ 10), občasni (≥ 1/ 1. 000, < 1/ 100), redki (≥ 1/ 10. 000, < 1/ 1. 000), zelo redki (< 1/ 10. 000).
Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, granulocytopenia, anaemia
Trombotična trombocitopenična purpura (TTP) (glejte poglavje 4. 4), aplastična anemija, pancitopenija, agranulocitoza, huda trombocitopenija, granulocitopenija, anemija
Serum sickness, anaphylactoid reactions
Serumska bolezen, anafilaktoidne reakcije Halucinacije, zmedenost
reported with fatal outcome), headache, paraesthesia, dizziness Eye disorders
krvavitev (opisani so primeri s smrtnim izidom), glavobol, parestezije, omotica Očesne bolezni
17
17 Organski sistem
Very rare
krvavitev
Gastrointestinal Gastrointestinal
retroperitonealna krvavitev s smrtnim
Gastric ulcer and
prebavila,
Retroperitoneal Gastrointestinal and
dvanajstniku,
disorders
izidom, pankreatitis,
haemorrhage, diarrhoea, abdominal pain, dyspepsia
driska, bolečine v
duodenal ulcer, haemorrhage gastritis, vomiting, nausea, constipation, flatulence
gastritis, bruhanje, navzea, zaprtje,
retroperitoneal haemorrhage with fatal outcome, pancreatitis, colitis (including ulcerative or lymphocytic colitis), stomatitis
ulceroznim ali limfocitnim kolitisom), stomatitis
Acute liver failure, hepatitis, abnormal liver function test
Akutna odpoved jeter, hepatitis, nenormalni testi jetrne funkcije Bulozen dermatitis
Rash, pruritus, skin bleeding (purpura)
(toksična epidermalna
Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme), angioedema, rash erythematous, urticaria, eczema, lichen planus
podkožja
Musculoskeletal, connective tissue and bone disorders
kožne krvavitve (purpura)
Musculo-skeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia
nekroliza, Stevens - Johnsonov sindrom, multiformni eritem), angioedem, eritematozen izpuščaj, urtikarija, ekcem, lihen planus
Renal and urinary disorders
Bolezni mišično - skeletnega sistema in vezivnega tkiva
Glomerulonephritis, blood creatinine increased
Mišično- skeletne krvavitve (hemartroza), artritis, artralgija, mialgija
General disorders and administration site conditions
Bolezni sečil Splošne težave in spremembe na mestu aplikacije
Fever
Hematurija
Bleeding time prolonged, neutrophil count decreased, platelet count decreased
Podaljšan čas krvavitve, zmanjšano število nevtrofilcev, zmanjšano število trombocitov