natgillin/translations-raw huggingface dataset:
ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTION REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
PRILOGA II A. IZDELOVALEC (IZDELOVALCI), ODGOVORNI ZA SPROŠČANJE SERIJE B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
4.7 Effects on ability to drive and use machines Clopidogrel has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Klopidogrel nima ali ima zanernarljiv vpliv na sposobnost za vožnjo in upravljanje strojev.
You have been prescribed Clopidogrel Apotex to help prevent blood clots and reduce the risk of these severe events because:
Zdravilo Clopidogrel Apotex vam je predpisani za pomoč pri preprečevanju nastajanja krvnih strdkov in za zmanjšanje tveganja teh hudih dogodkov, ker:
PHARMACEUTICAL FORM Film-coated tablet.
FARMACEVTSKA OBLIKA filmsko obložena tableta.
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), not known (cannot be estimated from the available data).
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), neznana (ni mogoče oceniti iz razpoložljivih podatkov.
Excipients with a known effect:
Pomožne snovi z znanim učinkom:
Some other medicines may influence the use of Clopidogrel Apotex or vice versa.
Nekatera druga zdravila lahko vplivajo na uporabo zdravila Clopidogrel Apotex in obratno.
The results obtained in populations with different characteristics (e.g. unstable angina or non-Q-wave MI, low to high risk levels, diabetes, need for revascularisation, age, gender, etc.) were consistent with the results of the primary analysis.
Rezultati, pridobljeni pri populacijah z različnimi karakteristikami (npr. nestabilna angina, MI brez Qzobca, visoka do nizka raven tveganja, diabetes, potreba po revaskularizaciji, spol, starost, itd), so skladni z rezultati primarne analize.
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.
Druga zdravila: Številne druge klinične študije so izvedli s klopidogrelom in drugimi sočasno danimi zdravili, da bi proučili potencial za farmakodinamične in farmakokinetične interakcije.
You should take Clopidogrel Apotex for as long as your doctor continues to prescribe it.
Zdravilo Clopidogrel Apotex morate jemati, vse dokler vam ga vaš zdravnik predpisuje.
In addition, a subgroup analysis by age suggested that the benefit of clopidogrel in patients over 75 years was less than that observed in patients 75 years.
Razen tega analiza podskupin glede na starost nakazuje, da so koristi klopidogrela pri bolnikih, starejših od 75 let, manjše od tistih, ki so jih opazili pri bolnikih ≤ 75 let.
Marketing Authorisation Holder and Manufacturers:
Imetnik dovoljenja za promet z zdravilom in izdelovalci:
• Paediatric population Clopidogrel should not be used in children because of efficacy concerns (see section 5.1).
• Pediatrična populacija Klopidogrel naj se pri otrocih ne uporablja iz razlogov, ki zadevajo učinkovitost (glejte poglavje 5.1.
Contact your doctor immediately if you experience: - fever, signs of infection or extreme tiredness.
Nemudoma se posvetujte s svojim zdravnikom, če se pri vas pojavijo: zvišana telesna temperatura, znaki okužbe ali huda utrujenost.
Pregnancy and breast-feeding It is preferable not to take this medicine during pregnancy.
Nosečnost in dojenje Priporočljivo je, da se tega zdravila v nosečnosti ne uporablja.
Prevention of atherothrombotic and thromboembolic events in atrial fibrillation
Preprečevanje aterotrombotičnih in trombemboličnih dogodkov pri atrijski fibrilaciji
Clopidogrel Apotex with food and drink Clopidogrel Apotex may be taken with or without food.
Zdravilo Clopidogrel Apotex skupaj s hrano in pijačo Zdravilo Clopidogrel Apotex lahko jemljete s hrano ali brez nje.
Published frequencies for the poor CYP2C19 metaboliser genotypes are approximately 2% for Caucasians, 4% for Blacks and 14% for Chinese.
Objavljene pogostnosti genotipa slabega metabolizatorja s CYP2C19 so približno 2 % pri belcih, 4 % pri črncih in 14 % pri Kitajcih.
There have been a number of retrospective analyses, however, to evaluate this effect in patients treated with clopidogrel for whom there are genotyping results: CURE (n=2721), CHARISMA (n=2428), CLARITY-TIMI 28 (n=227), TRITON-TIMI 38 (n=1477), and ACTIVE-A (n=601), as well as a number of published cohort studies.
Opravljene pa so bile številne retrospektivne analize za oceno tega učinka pri bolnikih, zdravljenih s klopidogrelom, za katere so na voljo rezultati genotipizacije: CURE (n = 2721), CHARISMA (n = 2428), CLARITY-TIMI 28 (n = 227), TRITONTIMI 38 (n = 1477) in ACTIVE-A (n = 601), poleg tega pa tudi številne objavljene kohortne študije.
Bleeding time prolonged, neutrophil count decreased, platelet count decreased * Information related to clopidogrel with frequency “not known”.
Podaljšan čas krvavitve, zmanjšano število nevtrofilcev, zmanjšano število trombocitov * Podatki se nanašajo na klopidogrel s pogostnostjo “ neznani”.
Analysis of total mortality as a secondary endpoint did not show any significant difference between clopidogrel (5.8%) and ASA (6.0%).
Analiza skupne umrljivosti kot sekundarnega opazovanega dogodka ni pokazala pomembne razlike med klopidogrelom (5,8 %) in ASA
Warnings and precautions If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Apotex:
Opozorila in previdnostni ukrepi Če katero koli od spodaj navedenih stanj velja za vas, morate o tem obvestiti svojega zdravnika, preden boste vzeli zdravilo Clopidogrel Apotex:
Blisters of white PVC/PE/PVDC-aluminium foil or PA/ALL/PVC-aluminium foil.
Pretisni omoti iz bele PVC/PE/PVDC-aluminijaste folije ali PA/ALL/PVC-aluminijaste folije.
Pharmacotherapeutic group: platelet aggregation inhibitors excl. heparin, ATC Code: B01AC-04.
Farmakoterapevtska skupina: zaviralci agregacije trombocitov brez heparina, oznaka ATC: B01AC-04.
You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Clopidogrel and acetylsalicylic acid for this condition.
Povedati so vam morali, da so "peroralni antikoagulanti" pri tej motnji učinkovitejši kot acetilsalicilna kislina ali kombinirana uporaba zdravila Clopidogrel Apotex in acetilsalicilne kisline.
Then, the recommended dose is one 75-mg tablet of Clopidogrel Apotex per day as described above.
Nato je priporočeni odmerek ena 75-mg tableta zdravila Clopidogrel Apotex na dan, kot je opisano zgoraj.
The recommended dose, including for patients with a condition called ‘atrial fibrillation' (an irregular heartbeat), is one 75 mg tablet of Clopidegrel Apotex per day to be taken orally with or without food, and at the same time each day.
Priporočeni odmerek, vključno za bolnike s stanjem, imenovanim "atrijska fibrilacija" (neredno bitje srca), je ena 75-mg tableta zdravila Clopidegrel Apotex na dan, ki se jemlje peroralno s hrano ali brez nje, vsak dan ob istem času.
Pharmathen S.A., 6 Dervenakion 15351 Pallini Attiki Greece
Pharmathen S.A., 6 Dervenakion 15351 Pallini Attiki Grčija
The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY, COMMIT and ACTIVE-A studies are discussed below.
Klinično pomembni neželeni učinki, zabeleženi v študijah CAPRIE, CURE, CLARITY, COMMIT in ACTIVE-A so predstavljeni spodaj.
Side effects with frequency not known (frequency cannot be estimated from the available data): Hypersensitivity reactions with chest or abdominal pain, persistent low blood sugar symptoms.
Neželeni učinki z neznano pogostnostjo (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): Preobčutljivostne reakcije z bolečinami v prsih ali trebuhu, simptomi trajno nizke ravni sladkorja v krvi.
As no clinical data on exposure to clopidogrel during pregnancy are available, it is preferable not to use clopidogrel during pregnancy as a precautionary measure.
Ker kliničnih podatkov o izpostavljenosti klopidogrelu med nosečnostjo ni, je kot previdnostni ukrep priporočeno, da se klopidogrela v nosečnosti ne uporablja.
If you take more Clopidogrel Apotex than you should Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Če ste vzeli večji odmerek zdravila Clopidogrel Apotex, kot bi smeli Zaradi povečanega tveganja krvavitve se posvetujte s svojim zdravnikom ali oddelkom najbližje bolnišnične nujne zdravniške pomoči.
The most common side effect reported with Clopidogrel Apotex is bleeding.
Najpogostejši neželeni učinek, o katerem so poročali z zdravilom Clopidogrel Apotex, je krvavitev.
EU/1/09/568/001-018
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/568/001-018
Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleed, blood in the urine.
Krvavitve se lahko pojavijo kot krvavitve iz želodca ali črevesja, kot modrice in hematom (neobičajne krvavitve ali modrice pod kožo), krvavitve iz nosu, krvi v urinu.
If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel Apotex in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Če ste doživeli hudo bolečino v prsih (nestabilna angina pektoris ali srčni napad), so vam morda predpisali zdravilo Clopidogrel Apotex v kombinaciji z acetilsalicilno kislino, učinkovino, ki je prisotna v številnih zdravilih, ki se uporabljajo za lajšanje bolečine in zniževanje zvišane telesne temperature.
Pharmathen S.A. 6, Dervenakion 15351 Pallini Attiki Greece
Pharmathen S.A. 6, Dervenakion 15351 Pallini Attiki Grčija
EU/1/09/568/017 Cartons of 90 film-coated tablets in PA/ALL/PVDC /Alu blisters EU/1/09/568/018 Cartons of 100 film-coated tablets in PA/ALL/PVDC /Alu blisters
EU/1/09/568/001-018 škatle s 100 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih
The ACTIVE-A study (N=7,554) was a multicenter, randomized, double-blind, placebo-controlled study which compared clopidogrel 75 mg/day + ASA (N=3,772) to placebo + ASA (N=3,782).
Študija ACTIVE-A (n=7.554) je bila multicentrična, randomizirana, dvojno slepa, s placebom kontrolirana študija, ki je primerjala klopidogrel 75 mg/dan + ASA (n=3.772) in placebo + ASA (n=3.782).
Clopidogrel Apotex is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Zdravilo Clopidogrel Apotex jemljejo odrasli za preprečevanje nastanka krvnih strdkov (trombov) v otrdelih krvnih žilah (arterijah), proces je znan kot aterotromboza in lahko vodi do aterotrombotičnih dogodkov (kot so kap, srčni napad ali smrt).
repaglinide, medicine to treat diabetes, paclitaxel, medicine to treat cancer.
- repaglinid, zdravilo za zdravljenje sladkorne bolezni, - paklitaksel, zdravilo za zdravljenje raka.
If you forget to take a dose of Clopidogrel Apotex, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Če pozabite vzeti odmerek zdravila Clopidogrel Apotex in se nanj spomnite do 12 ur po ustaljenem času takoj vzemite tableto in nato vzemite naslednjo tableto spet ob ustaljenem času jemanja.
If you become pregnant while taking Clopidogrel Apotex, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Če med zdravljenjem z zdravilom Clopidogrel Apotex zanosite, se takoj posvetujte s svojim zdravnikom, saj jemanje klopidogrela med nosečnostjo ni priporočljivo.
Pink, round, biconvex, film-coated tablets.
Rožnate, okrogle, bikonveksne fimsko obložene tablete.
The CYP2C19*2 and CYP2C19*3 alleles account for the majority of reduced function alleles in Caucasian (85%) and Asian (99%) poor metabolisers.
Na račun alelov CYP2C19*2 in CYP2C19*3 gre 85 % večina alelov z zmanjšanim delovanjem pri belcih (85 %) in pri Azijcih (99 %), ki so slabi metabolizatorji.
Your doctor should have prescribed Clopidogrel plus acetylsalicylic acid if you cannot take ‘oral anticoagulants' and you do not have a risk of major bleeding.
Zdravnik naj bi vam predpisal zdravilo Clopidogrel Apotex skupaj z acetilsalicilno kislino, če ne morete prejemati "peroralnih antikoagulantov" ali če nimate tveganja za večjo krvavitev.
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,.
The active metabolite is formed mostly by CYP2C19 with contributions from several other CYP enzymes, including CYP1A2 CYP2B6 and CYP3A4.
Aktivni presnovek nastane predvsem z delovanjem CYP2C19, k nastanku pa pripomorejo tudi drugi encimi CYP, vključno s CYP1A2, CYP2B6 in CYP3A4.
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.
Clopidogrel has been tested in a range of in vitro and in vivo genotoxicity studies,and showed no genotoxic activity.
Klopidogrel so preizkušali v številnih in vitro ter in vivo študijah genotoksičnosti in ni pokazal nobenega genotoksičnega učinka.
Driving and using machines Clopidogrel Apotex is unlikely to affect your ability to drive or to use machines.
Ni verjetno, da bi zdravilo Clopidogrel Apotex vplivalo na vašo sposobnost za vožnjo ali upravljanje strojev.
Each film-coated tablet contains 2.5 mg of lactose (as monohydrate).
Ena filmsko obložena tableta vsebuje 2,5 mg laktoze (v obliki laktoze monohidrata).
Clopidogrel Apotex film-coated tablets are pink, round and biconvex.
Clopidogrel Apotex filmsko obložene tablete so rožnate barve, okrogle in bikonveksne oblike.
In addition, IPA was 32% (24 hours) and 61% (Day 5), which were greater than in the poor metabolisers receiving the 300 mg/75 mg regimen,and were similar to the other CYP2C19 metaboliser groups receiving the 300 mg/75 mg regimen.
Poleg tega je bilo IPA 32 % (24 ur) in 61 % (5. dan), kar je več kot pri slabih metabolizatorjih, ki so prejemali shemo 300 mg/75 mg, in podobno kot pri drugih metabolizatorskih skupinah s CYP2C19, ki so prejemale shemo 300 mg/75 mg.
Patients randomized in the ACTIVE program were those presenting with documented AF, i.e., either permanent AF or at least 2 episodes of intermittent AF in the past 6 months, and had at least one of the following risk factors: age 75 years or age 55 to 74 years and either diabetes mellitus requiring drug therapy, or documented previous MI or documented coronary artery disease; treated for systemic hypertension; prior stroke, transient ischaemic attack (TIA), or non-CNS systemic embolus; left ventricular dysfunction with left ventricular ejection fraction <45%; or documented peripheral vascular disease.
V program ACTIVE so bili randomizirani bolniki, ki so imeli dokumentirano AF, tj. bodisi permanentno AF ali vsaj 2 epizodi intermitentne AF v zadnjih 6 mesecih ter vsaj enega od naslednjih dejavnikov tveganja: starost ≥ 75 let ali starost od 55 do 74 let in bodisi sladkorno bolezen, ki je zahtevala zdravljenje z zdravili, ali dokumentiran predhodni MI ali dokumentirano koronarno bolezen; zdravljenje zaradi sistemske hipertenzije; predhodno možgansko kap, tranzitorno ishemično atako (TIA) ali sistemski embolus (ne v osrednjem živčevju); disfunkcijo levega prekata z iztisnim deležem levega prekata (LVEF) < 45 %; ali dokumentirano bolezen perifernih žil.
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel Apotex.
Če ste noseči ali mislite, da ste noseči, morate o tem obvestiti svojega zdravnika ali farmacevta, preden vzamete zdravilo Clopidogrel Apotex.
If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel Apotex
Če menite, da se kar koli od navedenega nanaša na vas, ali če ste kakorkoli v dvomih, se posvetujte s svojim zdravnikom, preden boste vzeli zdravilo Clopidogrel Apotex.
You have an irregular heartbeat, a condition called ‘atrial fibrillation', and you cannot take medicines known as ‘oral anticoagulants' (vitamin K antagonists) which prevent new clots from forming and prevent existing clots from growing.
imate neredno bitje srca, motnjo, imenovano "atrijska fibrilacija", in ne morete prejemati zdravil, imenovanih "peroralni antikoagulanti" (antagonisti vitamina K), ki preprečujejo nastajanje novih krvnih strdkov in preprečujejo rast obstoječih krvnih strdkov.
In patients with acute ST-segment elevation MI, safety and efficacy of clopidogrel have been evaluated in 2 randomised, placebo-controlled, double-blind studies, CLARITY and COMMIT.
Pri bolnikih z akutnim miokardnim infarktom z elevacijo ST-spojnice sta bili varnost in učinkovitost klopidogrela vrednoteni v dveh randomiziranih, s placebom kontroliranih, dvojno slepih študijah, CLARITY in COMMIT.
The use of clopidogrel in CURE was associated with a decrease in the need of thrombolytic therapy (RRR = 43.3%; CI: 24.3%, 57.5%) and GPIIb/IIIa inhibitors (RRR = 18.2%; CI: 6.5%, 28.3%).
Uporaba klopidogrela v CURE je bila povezana z zmanjšano potrebo po zdravljenju s trombolitiki (zmanjšanje RT= 43,3 %; IZ: 24,3 %, 57,5 %) in inhibitorji glikoproteinov IIb/IIIa (zmanjšanje RT=18,2 %; IZ: 6,5 %, 28,3 %).
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.
Hypromellose (E464) Lactose monohydrate Triacetin (E1518) Titanium dioxide (E171) Red iron oxide (E172)
laktoza monohidrat triacetin (E1518) titanov dioksid (E171) rdeči železov oksid (E172)
Switching from a more potent P2Y12 receptor inhibitor to clopidogrel in association with aspirin after acute phase in ACS has been evaluated in two randomized investigator-sponsored studies (ISS)TOPIC and TROPICAL-ACS - with clinical outcome data.
Prehod z močnejšega zaviralca receptorjev P2Y12 na klopidogrel v kombinaciji z acetilsalicilno kislino po akutni fazi AKS so ocenili v dveh randomiziranih, s strani raziskovalcev sponzoriranih študij (ISSinvestigator-sponsored studies) - TROPIC in TROPICAL-ACS - s podatki o kliničnih izidih.
What Clopidogrel Apotex is and what it is used for
Kaj je zdravilo Clopidogrel Apotex in za kaj ga uporabljamo
Oral use.
peroralna uporaba.
There is no evidence that other medicinal products that reduce stomach acid such as H2 blockers or antacids interfere with antiplatelet activity of clopidogrel.
Ni dokazov, da druga zdravila za zmanjševanje želodčne kisline, npr. antagonisti histaminskih receptorjev H2 ( ali antacidi, ovirajo antitrombocitno delovanje klopidogrela.
For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow.
Pri zdravljenju tega stanja vam je zdravnik v zamašeno ali zoženo arterijo morda moral vstaviti stent (žilno opornico), da bi žilo tako razširil in obnovil pretok krvi.
Do not use this medicine after the expiry date which is stated on the carton and on the blister, after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
- In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.
Pri odraslih bolnikih z atrijsko fibrilacijo, ki imajo vsaj en dejavnik tveganja za žilne dogodke in ki niso primerni za zdravljenje z antagonisti vitamina K (VKA) ter imajo majhno tveganje za krvavitev, je klopidogrel v kombinaciji z ASA indiciran za preprečevanje aterotrombotičnih in trombemboličnih dogodkov, vključno z možgansko kapjo.
• Adult patients suffering from acute coronary syndrome: - 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).
• odraslih bolnikih z akutnim koronarnim sindromom: 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).
Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); swelling in the mouth; blisters of the skin; skin allergy; sore mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in taste or loss of taste of food.
zlatenica, huda bolečina v trebuhu z bolečinami v hrbtu ali brez njih, zvišana telesna temperatura, težave pri dihanju, ki so včasih povezane s kašljem, splošne alergijske reakcije (na primer, splošni občutek toplote z nenadnim nelagodjem do nezavesti), oteklina v ustih, mehurji na koži, kožna alergija, vnetje v ustih (stomatitis), znižanje krvnega tlaka, zmedenost, halucinacije, bolečine v sklepih, bolečine v mišicah, motnje v okušanju ali izguba okusa hrane.
In patients with atrial fibrillation, clopidogrel should be given as a single daily dose of 75 mg. ASA (75-100 mg daily) should be initiated and continued in combination with clopidogrel (see section 5.1).
Bolniki z atrijsko fibrilacijo morajo klopidogrel dobivati v enem dnevnem odmerku 75 mg. ASA (75100 mg na dan) je treba uvesti in nadaljevati v kombinaciji s klopidogrelom (glejte poglavje 5.1).
The dose of 0.2 mg/kg achieved the mean percent inhibition of 49.3% (5 µM ADP-induced platelet aggregation) which was comparable to that of adults taking Clopidogrel 75 mg/day.
Odmerek 0,2 mg/kg je dosegel povprečno 49,3 % zavrtje (agregacija trombocitov povzročena s 5 µM ADP), primerljivo kot pri odraslih ob uporabi klopidogrela v odmerku 75 mg/dan.
Caution is required in patients treated concomitantly with clopidogrel and CYP2C8 substrate medicinal products (see section 4.5).
Previdnost je potrebna pri bolnikih, ki sočasno jemljejo klopidogrel in zdravila, ki so -substratie CYP2C8 (glejte poglavje 4.5).
TROPICAL-ACS (Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment for Acute Coronary Syndromes)
TROPICAL-ACS (Preverjanje odzivnosti na zavrtje trombocitov ob kroničnem antiagregacijskem zdravljenju akutnih koronarnih sindromov [Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment for Acute Coronary Syndromes])
If you experience prolonged bleeding when taking Clopidogrel Apotex
Če doživite podaljšanje krvavitve v času jemanja zdravila Clopidogrel Apotex
As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel Apotex.
Iz varnostnih razlogov naj se z dojenjem med zdravljenjem z zdravilom Clopidogrel Apotex ne nadaljuje.