natgillin/translations-raw huggingface dataset:
If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
• Ako ste alergični (preosjetljivi) na klopidogrel ili na neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
If you suffer from severe liver disease.
• Ako patite od teške bolesti jetre.
Macrogol 6000
Jezgra tablete: makrogol 6000
You should tell your doctor if a surgery (including dental) is planned.
• Obavijestite svog liječnika ako planirate kirurški zahvat (uključujući stomatološke zahvate).
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Nositelj odobrenja mora osigurati da je farmakovigilancijski sustav, prikazan u Modulu 1.8.1. odobrenja za stavljanje gotovog lijeka u promet, ustrojen i funkcionalan prije i za vrijeme dok je lijek na tržištu.
Clopidogrel is indicated in adults for the secondary prevention of atherothrombotic events in:
Klopidogrel je indiciran kod odraslih za sekundarnu prevenciju aterotrombotičkih događaja u:
If a patient is to undergo elective surgery and antiplatelet effect is temporarily not desirable, clopidogrel should be discontinued 7 days prior to surgery.
Ako se bolesnik planira podvrgnuti elektivnom kirurškom zahvatu pa antitrombocitni učinak trenutno nije poželjan, davanje klopidogrela treba prekinuti 7 dana prije zahvata.
Clopidogrel has been evaluated for safety in more than 42,000 patients who have participated in clinical studies, including over 9,000 patients treated for 1 year or more.
Sigurnost primjene klopidogrela ispitana je na više od 42 000 bolesnika koji su sudjelovali u kliničkim ispitivanjima, uključujući više od 9000 bolesnika koji su lijek primali godinu ili više dana.
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).
<1/100); rijetke (≥1/10 000, <1/1000); vrlo rijetke (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
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.
Određeni broj ostalih kliničkih studija provodio se s klopidogrelom i nekim drugim istodobno primjenjivanim lijekovima kako bi se ispitala mogućnost farmakodinamičkih i farmakokinetičkih interakcija.
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/
Detaljne informacije o ovom lijeku dostupne su na intenetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu/.
Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „EXP “.
In CURE, 823 (6.6%) patients received concomitant GPIIb/IIIa receptor antagonist therapy.
U studiji CURE 823 (6,6%) bolesnika istodobno je primalo antagoniste receptora GPIIb/IIIa.
Neutropenia, including severe neutropenia
uključujući tešku neutropeniju
White to off-white, marbled, round and biconvex film-coated tablets.
Bijele do gotovo bijele, mramorne, okrugle i bikonveksne filmom obložene tablete.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 July 2009
Datum prvog odobrenja: 28.07.2009.
7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 84 film-coated tablets 90 film-coated tablets 100 film-coated tablets
7 filmom obloženih tableta 14 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 50 filmom obloženih tableta 84 filmom obložene tablete 90 filmom obloženih tableta 100 filmom obloženih tableta
The other ingredients are (see section 2 ‘Clopidogrel ratiopharm GmbH contains hydrogenated castor oil'):
Drugi sastojci su (vidjeti dio 2. „Klopidogrel ratiopharm GmbH sadrži hidrogenirano ricinusovo ulje“)::
Your doctor may order blood tests.
• Vaš liječnik će možda odrediti da Vam se naprave pretrage krvi.
This may cause stomach upset or diarrhoea.
To može uzrokovati želučane tegobe ili proljev.
Bleeding at puncture site
Krvarenje na mjestu punkcije
Alu/Alu blisters containing 7, 14, 28, 30, 50, 84, 90 and 100 film-coated tablets packed in cardboard cartons.
Al/Al blisteri, koji sadrže 7, 14, 28, 30, 50, 84, 90 i 100 filmom obloženih tableta, pakirani u kartonske kutije.
It is preferable not to take this product during pregnancy.
Ne preporučuje se uzimanje ovog lijeka za vrijeme trudnoće.
If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain.
• Ako imate poremećaj koji trenutno izaziva krvarenje, kao što je, primjerice, želučani čir ili krvarenje u mozgu.
Rash, pruritus, skin bleeding (purpura)
Osip, svrbež, krvarenja na koži (purpura)
EU/1/09/541/001 - 14 film-coated tablets EU/1/09/541/002 - 28 film-coated tablets EU/1/09/541/003 - 30 film-coated tablets EU/1/09/541/004 - 50 film-coated tablets EU/1/09/541/005 - 84 film-coated tablets EU/1/09/541/006 - 90 film-coated tablets EU/1/09/541/007 - 100 film-coated tablets EU/1/09/541/008 - 7 film-coated tablets
EU/1/09/541/001 - 14 filmom obloženih tableta EU/1/09/541/002 - 28 filmom obloženih tableta EU/1/09/541/003 - 30 filmom obloženih tableta EU/1/09/541/004 - 50 filmom obloženih tableta EU/1/09/541/005 - 84 filmom obloženih tableta EU/1/09/541/006 - 90 filmom obloženih tableta EU/1/09/541/007 - 100 filmom obloženih tableta EU/1/09/541/008 - 7 filmom obloženih tableta
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel ratiopharm GmbH (4 tablets of 75 mg) once at the start of treatment.
Ako ste imali jake bolove u prsištu (nestabilna angina ili srčani udar), liječnik Vam u početku liječenja može jednokratno dati 300 mg Klopidogrel ratiopharm GmbH (4 tablete od 75 mg).
A total of 99.7% of patients received fibrinolytics (fibrin specific: 68.7%, non-fibrin specific: 31.1%), 89.5% heparin, 78.7% beta blockers, 54.7% ACE inhibitors and 63% statins.
Fibrinolitike je primalo 99,7% bolesnika (fibrin-specifični: 68,7%, fibrin-nespecifični: 31,1%), 89,5% heparin, 78,7% beta blokatore, 54,7% ACE inhibitore i 63%
Intracranial bleeding (some cases were reported with fatal outcome), headache, paraesthesia, dizziness
Intrakranijalno krvarenje (prijavljeni su neki slučajevi s fatalnim ishodom) glavobolja, parestezija, omaglica
Contains hydrogenated castor oil.
Sadrži hidrogenirano ricinusovo ulje.
- For more than 12 hours: patients should take the next dose at the regular scheduled time and should not double the dose.
Ako je prošlo više od 12 sati: bolesnik treba sljedeću dozu uzeti prema uobičajenom rasporedu i ne smije uzeti dvostruku dozu.
Some other medicines may influence the use of Clopidogrel ratiopharm GmbH or vice versa.
Neki lijekovi mogu utjecati na djelovanje Klopidogrel ratiopharm GmbH i obratno.
Do not use Clopidogrel ratiopharm GmbH if you notice any visible sign of damage of blister or film-coated tablets.
Klopidogrel ratiopharm GmbH se ne smije upotrijebiti ako primijetite vidljive znakove oštećenja blistera ili filmom obloženih tableta.
You should take Clopidogrel ratiopharm GmbH for as long as your doctor continues to prescribe it.
Klopidogrel ratiopharm GmbH trebate uzimati sve dok Vam ga liječnik propisuje.
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).
Omeprazol primjenjen u dozi od 80 mg dnevno, istodobno s klopidogrelom ili s razmakom od 12 sati od primjene dvaju lijekova, smanjio je izloženost aktivnom metabolitu klopidogrela za 45% (udarna doza) i 40% (doza održavanja).
In a relative bioavailability study in adults, the constituted solution of clopidogrel showed a similar extent and slightly higher rate of absorption of the main circulating (inactive) metabolite compared to the authorised tablet.
U relativnoj studiji bioraspoloživosti lijeka u odraslih, konstituirana otopina klopidogrela pokazala je sličan raspon i neznanto veću brzinu apsorpcije glavnog cirkulirajućeg (inaktivnog) metabolita, u usporedbi s tabletom.
If you have any further questions, ask your doctor or your pharmacist.
- Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
Platelets (so-called thrombocytes) are very small structures, which clump together during blood clotting.
Krvne pločice ili trombociti su vrlo mala krvna tjelešca koja se nakupljaju tijekom zgrušavanja krvi.
In TRITON-TIMI 38 and 3 of the cohort studies (Collet, Sibbing, Giusti) the combined group of patients with either intermediate or poor metaboliser status had a higher rate of cardiovascular events (death, myocardial infarction, and stroke) or stent thrombosis compared to extensive metabolisers.
U studiji TRITON-TIMI 38 i 3 kohortne studije (Collet, Sibbing, Giusti), kombinirana skupina bolesnika sa statusom umjerenih ili slabih metabolizatora, imala je veću stopu kardiovaskularnih događaja (smrt, infarkt miokarda i moždani udar) ili tromboze stenta, u usporedbi s brzim metabolizatorima.
Children and adolescents
• Odrasli i starije osobe
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.
Klinička djelotvornost i sigurnost Sigurnost primjene i djelotvornost klopidogrela procijenjena je u 4 dvostrukoslijepe studije koje su uključivale preko 80 000 bolesnika: studija CAPRIE, u kojoj se uspoređivao klopidogrel i ASK te CURE, CLARITY i COMMIT studije, u kojima se uspoređivalo djelovanje klopidogrela prema placebu, s tim da su obje terapije davane u kombinaciji s ASK i drugom standardnom terapijom.
You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects').
• Također, odmah obavijestite svog liječnika ukoliko se pojavi medicinsko stanje (koje se naziva trombotična trombocitopenična purpura ili "TTP") sa simptomima koji uključuju vrućicu i potkožne modrice koji se mogu pojaviti kao crvene točkice, sa ili bez neobjašnjivog teškog umora, zbunjenosti i žute boje kože ili očiju (žutica) (vidjeti dio 4. "Moguće nuspojave").
What Clopidogrel ratiopharm GmbH is and what it is used for What you need to know before you take Clopidogrel ratiopharm GmbH How to take Clopidogrel ratiopharm GmbH Possible side effects
Što je Klopidogrel ratiopharm GmbH i za što se koristi Što morate znati prije nego počnete uzmati Klopidogrel ratiopharm GmbH Kako uzimati Klopidogrel ratiopharm GmbH
Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.
Glavobolja, ulkus želuca, povraćanje, mučnina, zatvor, povećano stvaranje plinova u želucu ili crijevima, osip, svrbež, omaglica, osjećaj trnaca i utrnulosti.
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.
Žutica, jaka bol u trbuhu sa ili bez bolova u leđima, vrućica, teškoće pri disanju, ponekad povezane s kašljem, generalizirane alergijske reakcije (primjerice, sveukupni osjećaj vrućine s iznenadnom općom nelagodom do nesvjestice); oticanje u ustima, mjehurići na koži, kožne alergijske reakcije, upala u usnoj šupljini (stomatitis), pad krvnoga tlaka, zbunjenost, halucinacije, bol u zglobovima, bol u mišićima, poremećaj okusa ili gubitak osjeta okusa hrane.
Then, the recommended dose is one 75 mg tablet of Clopidogrel ratiopharm GmbH per day to be taken orally with or without food, and at the same time each day.
Nakon toga, preporučena doza Klopidogrel ratiopharm GmbH je jedna tableta od 75 mg dnevno koja se uzima kroz usta s obrokom ili bez obroka, u isto vrijeme svaki dan.
Clopidogrel ratiopharm GmbH 75 mg film-coated tablets are white to off-white, marbled, round and biconvex.
Klopidogrel ratiopharm GmbH 75 mg filmom obložene tablete su bijele do gotovo bijele, mramorne, okrugle i bikonveksne tablete.
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.
IPA iznosila je 32% (24 sata) i 61% (dan 5), što je više nego u slabih metabolizatora koji su primali režim doziranja od 300 mg/75 mg i slično je ostalim skupinama CYP2C19 metabolizatora koje su primale doze od 300 mg/75 mg.
Clopidogrel ratiopharm GmbH is unlikely to affect your ability to drive or to use machines.
Klopidogrel ratiopharm GmbH ne bi trebao utjecati na Vašu sposobnost upravljanja vozilima ili strojevima.
Musculo-skeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia
Mišićnokoštano krvarenje (hemartroza), artritis, artralgija, mijalgija
Medicinal products that are strong or moderate CYP2C19 inhibitors include, for example, omeprazole and esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine, and efavirenz.
Lijekovi su jaki ili umjereni inhibitori CYP2C19 uključuju, primjerice, omeprazol i esomeprazol, fluvoksamin, fluoksetin, moklobemid, vorikonazol, flukonazol, tiklopidin, karbamazepin i efavirenz.
EU/1/09/541/001 - Cartons of 14 film-coated tablets in Alu/Alu blisters EU/1/09/541/002 - Cartons of 28 film-coated tablets in Alu/Alu blisters EU/1/09/541/003 - Cartons of 30 film-coated tablets in Alu/Alu blisters EU/1/09/541/004 - Cartons of 50 film-coated tablets in Alu/Alu blisters EU/1/09/541/005 - Cartons of 84 film-coated tablets in Alu/Alu blisters EU/1/09/541/006 - Cartons of 90 film-coated tablets in Alu/Alu blisters EU/1/09/541/007 - Cartons of 100 film-coated tablets in Alu/Alu blisters EU/1/09/541/008 - Cartons of 7 film-coated tablets in Alu/Alu blisters
EU/1/09/541/001 - Kutije sa 14 filmom obloženih tableta u Al/Al blisterima EU/1/09/541/002 - Kutije sa 28 filmom obloženih tableta u Al/Al blisterima EU/1/09/541/003 - Kutije sa 30 filmom obloženih tableta u Al/Al blisterima EU/1/09/541/004 - Kutije sa 50 filmom obloženih tableta u Al/Al blisterima EU/1/09/541/005 - Kutije sa 84 filmom obloženih tableta u Al/Al blisterima EU/1/09/541/006 - Kutije sa 90 filmom obloženih tableta u Al/Al blisterima EU/1/09/541/007 - Kutije sa 100 filmom obloženih tableta u Al/Al blisterima EU/1/09/541/008 - Kutije sa 7 filmom obloženih tableta u Al/Al blisterima
Fifteen percent (15.0%) of patients in the clopidogrel group and 21.7% in the placebo group reached the primary endpoint, representing an absolute reduction of 6.7% and a 36% odds reduction in favour of clopidogrel (95% CI: 24, 47%; p< 0.001), mainly related to a reduction in occluded infarct-related arteries.
Petnaest posto (15,0%) bolesnika u skupini s klopidogrelom i 21,7% u skupini s placebom dostigli su primarni ishod, što predstavlja apsolutno smanjenje od 6,7% i smanjenje izgleda (engl. odds reduction) od 36% u korist klopidogrela (95% CI: 24, 47%; p<0,001), većinom povezano sa smanjenjem okluzije arterija povezanih s infarktom.
Consistent with the above results, in a meta-analysis including 6 studies of 335 clopidogrel-treated subjects at steady state, it was shown that active metabolite exposure was decreased by 28% for intermediate metabolisers, and 72% for poor metabolisers while platelet aggregation inhibition (5 μM ADP) was decreased with differences in IPA of 5.9% and 21.4%, respectively, when compared to extensive metabolisers.
U skladu s gore navedenim rezultatima, u metaanalizi koja je uključivala 6 studija s 335 osoba liječenih klopidogrelom u stanju dinamičke ravnoteže, pokazano je da je izloženost aktivnom metabolitu smanjena za 28% za umjerene metabolizatore te 72% za slabe metabolizatore, dok je inhibicija agregacije trombocita (5 μM ADP) smanjena s razlikama za vrijednsoti IPA-e od 5,9%, odnosno 21,4%, u usporedbi s brzim metabolizatorima.
swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin.
- oticanje u ustima ili kožni poremećaji kao što su osip i svrbež te mjehurići na koži.
-Very rare side effects (may affect up to 1 in 10,000 people):
-Vrlo rijetke nuspojave (mogu se javiti u manje od 1 na 10 000 osoba):
Clopidogrel ratiopharm GmbH contains the active ingredient Clopidogrel which belongs to a group of medicines called antiplatelet medicinal products.
Klopidogrel ratiopharm GmbH sadrži djelatnu tvar klopidrogel i pripada skupini lijekova koji se nazivaju antitrombocitni lijekovi.
Acute liver failure, hepatitis, abnormal liver function test
Akutno zatajenje jetre, hepatitis, abnormalni nalazi jetrene funkcije
Contents of the pack and other information What Clopidogrel ratiopharm GmbH contains
Sadržaj pakiranja i druge informacije Što Klopidogrel ratiopharm GmbH sadrži
Clopidogrel ratiopharm GmbH with food and drink
Klopidogrel ratiopharm GmbH s hranom i pićem
If a dose is missed: - Within less than 12 hours after regular scheduled time: patients should take the dose immediately and then take the next dose at the regular scheduled time.
Ako je prošlo manje od 12 sati nakon uobičajenog termina uzimanja lijeka: bolesnik treba odmah uzeti dozu, a sljedeću dozu treba uzeti prema uobičajenom rasporedu.
You have been prescribed Clopidogrel ratiopharm GmbH to help prevent blood clots and reduce the risk of these severe events because:
Vam je propisan za sprječavanje stvaranja krvnih ugrušaka i smanjivanje opasnosti od ovih ozbiljnih događaja jer:
Clopidogrel ratiopharm GmbH may be taken with or without food.
Klopidogrel ratiopharm GmbH se može uzimati s obrokom ili bez obroka.
What Clopidogrel ratiopharm GmbH is and what it is used for
Što je Klopidogrel ratiopharm GmbH i za što se koristi
Serum sickness, anaphylactoid reactions, cross-reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)*, insulin autoimmune syndrome, which can lead to severe hypoglycemia, particularly in patients with HLA DRA4 subtype (more frequent in the Japanese population)*
Serumska bolest, anafilaktoidne reakcije, križno reaktivna preosjetljivost na lijekove iz skupine tienopiridina (kao što su tiklopidin, prasugrel) (vidjeti dio 4.4)*, autoimuni inzulinski sindrom koji može dovesti do teške hipoglikemije, osobito u bolesnika s podtipom
Other side effects are:
Ostale nuspojave uključuju :
Clopidogrel ratiopharm GmbH contains hydrogenated castor oil which may cause stomach upset and diarrhoea.
Klopidogrel ratiopharm GmbH sadrži hidrogenirano ricinusovo ulje koje može uzrokovati nadražaj želuca i proljev.
They are supplied in cardboard cartons containing 7, 14, 28, 30, 50, 84, 90 and 100 tablets in aluminium blisters.
Dostupne su u kartonskim kutijama koje sadrže 7, 14, 28, 30, 50, 84, 90
How to store Clopidogrel ratiopharm GmbH Contents of the pack and other information
Kako čuvati Klopidogrel ratiopharm GmbH Sadržaj pakiranja i druge informacije
-Common side effects (may affect up to 1 in 10 people): Diarrhoea, abdominal pain, indigestion or heartburn.
-Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba): Proljev, bol u trbuhu, probavne tegobe ili žgaravica.
Reporting of suspected adverse reactions
Prijava sumnji na nuspojave
After repeated doses of 75 mg clopidogrel per day in subjects with severe renal disease (creatinine clearance from 5 to 15 ml/min), inhibition of ADP-induced platelet aggregation was lower (25%) than that observed in healthy subjects, however, the prolongation of bleeding time was similar to that seen in healthy subjects receiving 75 mg of clopidogrel per day.
Nakon ponovljenih doza od 75 mg klopidogrela dnevno, inhibicija ADP-om inducirane agregacije trombocita bila je niža (25%) u ispitanika s teško narušenom funkcijom bubrega (klirens kreatinina od 5 do 15 ml/min) u usporedbi sa zdravim ispitanicima, iako je produljenje vremena krvarenja bilo slično onom zabilježenom u zdravih bolesnika koji su primali 75 mg klopidogrela dnevno.
The most common side effect reported with clopidogrel is bleeding.
Najčešća nuspojava klopidogrela jest krvarenje.
Other concomitant therapy: Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel.
Ostala istodobna terapija: s obzirom da se klopidogrel do svog aktivnog metabolita djelomično metabolizira putem CYP2C19, očekuje se da će primjena lijekova koji inhibiraju aktivnost ovog enzima rezultirati smanjenim razinama aktivnog metabolita klopidogrela.
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).
embrionalni/fetalni razvoj, porođaj ili postnatalni razvoj (vidjeti dio 5.3).
You have a condition of hardening of arteries (also known as atherosclerosis), and You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease (disturbed blood flow in arms or legs caused by vascular occlusions) or
- imate otvrdnuće arterija (koje se još zove ateroskleroza) te - ste već imali srčani udar, moždani udar ili imate stanje koje se zove bolest perifernih arterija, ili - ste imali teški oblik boli u prsištu, poznat pod nazivom “nestabilna angina” ili “infarkt miokarda” (srčani udar).
Clopidogrel ratiopharm GmbH contains hydrogenated castor oil
Klopidogrel ratiopharm GmbH sadrži hidrogenirano ricinusovo ulje
Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme, acute generalised exanthematous pustulosis (AGEP)), angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rash erythematous, or exfoliative, urticaria, eczema, lichen planus
(toksična epidermalna nekroliza, Stevens Johnsonov sindrom, erythema multiforme, akutna generalizirana egzantematozna pustuloza (AGEP)), angioedem, sindrom preosjetljivosti izazvane lijekom, osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (engl.
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 ‘Warnings and precautions').
- znakove oštećenja funkcije jetre kao što su žuta boja kože ili očiju (žutica), bez obzira jesu li povezani s krvarenjem koje se pojavljuje kao crvene točkice ispod kože i/ili zbunjenošću
What Clopidogrel ratiopharm GmbH looks like and contents of the pack
Kako Klopidogrel ratiopharm GmbH izgleda i sadržaj pakiranja
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.
U randomiziranoj, dvostrukoslijepoj studiji s paralelnim skupinama (CLARINET), 906 pedijatrijskih bolesnika (novorođenčad i dojenčad) s cijanotičnom kongenitalnom bolešću srca ublaženom sistemsko-plućnim arterijskim šantom, bilo je randomizirano da primaju klopidogrel u dozi od