natgillin/translations-raw huggingface dataset:
Frequency in Clinical Trials was similar in the medicinal product and placebo group.
Vidjeti dio 4.4 Učestalost u kliničkim ispitivanjima bila je slična u skupini koja je uzimala lijek i u skupini koja je uzimala placebo *Vidjeti dijelove 4.2 i 4.4.
FOSAVANCE 70 mg/2,800 IU tablets are available as modified capsule-shaped, white to off-white tablets marked with an outline of a bone image on one side and ‘710' on the other.
FOSAVANCE 70 mg/2800 IU tablete su bijele do gotovo bijele tablete oblika preinačene kapsule s oznakom kosti na jednoj strani i utisnutom oznakom '710' na drugoj.
The percentage of patients with vitamin D insufficiency (serum 25-hydroxyvitamin D < 37.5 nmol/l [< 15 ng/ml]) was significantly reduced by 62.5 % with FOSAVANCE (70 mg/2,800 IU) vs. alendronate-only (12 % vs. 32 %, respectively), through week 15.
Do 15. tjedna postotak bolesnica s nedostatkom vitamina D (25-hidroksivitamin D < 37,5 nmol/l [< 15 ng/ml] u serumu) u skupini koja je primala FOSAVANCE (70 mg/2800 IU) značajno je smanjen za 62,5%, naspram skupine koja je primala samo alendronat (12% naspram 32%).
FOSAVANCE 70 mg/2,800 IU tablets are available in packs containing 2, 4, 6 or 12 tablets.
FOSAVANCE 70 mg/2800 IU tablete dostupne su u pakiranjima koja sadrže 2, 4, 6 ili 12 tableta.
Each FOSAVANCE 70 mg/5,600 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 140 micrograms (5,600 IU) colecalciferol (vitamin D3).
Jedna FOSAVANCE 70 mg/5600 IU tableta sadrži 70 mg alendronatne kiseline (u obliku natrijevog trihidrata) i 140 mikrograma (5600 IU) kolekalciferola (vitamina D3).
In healthy adult subjects (males and females), following administration of FOSAVANCE 70 mg/5,600 IU after an overnight fast and two hours before a meal, the mean area under the serumconcentration-time curve (AUC0-80 hrs) for vitamin D3 (unadjusted for endogenous vitamin D3 levels) was 490.2 ng•hr/ml.
Prosječna površina ispod krivulje koncentracija u serumu: vrijeme (AUC0-80 hrs) za vitamin D3 u zdravih je odraslih ispitanika (oba spola) nakon primjene FOSAVANCE 70 mg/5600 IU tableta ujutro natašte i dva sata prije obroka (bez prilagodbe za endogene razine vitamina D3) iznosila 490,2 ng•hr/ml.
In healthy adult subjects (males and females), following administration of FOSAVANCE 70 mg/2,800 IU tablets after an overnight fast and two hours before a meal, the mean area under the serum-concentration-time curve (AUC0-120 hrs) for vitamin D3 (unadjusted for endogenous vitamin D3 levels) was 296.4 ng•hr/ml.
Prosječna površina ispod krivulje koncentracija u serumu : vrijeme (AUC0-120 hrs) za vitamin D3 u zdravih je odraslih ispitanika (oba spola) nakon primjene FOSAVANCE 70 mg/2800 IU tableta ujutro natašte i dva sata prije obroka (bez prilagodbe za endogene razine vitamina D3) iznosila 296,4 ng•hr/ml.
Each FOSAVANCE 70 mg/2,800 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2,800 IU) colecalciferol (vitamin D3).
Jedna FOSAVANCE 70 mg/2800 IU tableta sadrži 70 mg alendronatne kiseline (u obliku natrijevog trihidrata) i 70 mikrograma (2800 IU) kolekalciferola (vitamina D3).
After 15 weeks of treatment, the mean serum 25-hydroxyvitamin D levels were significantly higher (26 %) in the FOSAVANCE (70 mg/2,800 IU) group (56 nmol/l [23 ng/ml]) than in the alendronate-only group (46 nmol/l [18.2 ng/ml]).
D u serumu bile su značajno više (26%) u skupini koja je primala FOSAVANCE (70 mg/2800 IU) (56 nmol/l [23 ng/ml]) u odnosu na skupinu koja je primala samo alendronat (46 nmol/l [18,2 ng/ml]).
FOSAVANCE studies
Ispitivanja lijeka FOSAVANCE
Each tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2,800 IU) colecalciferol (vitamin D3).
Jedna tableta sadrži 70 mg alendronatne kiseline (u obliku natrijevog trihidrata) i 70 mikrograma (2800 IU) kolekalciferola (vitamina D3).
The effect of the lower dose of FOSAVANCE (alendronate 70 mg/vitamin D3 2,800 IU) plus an additional 2,800 IU Vitamin D3 for a total of 5,600 IU (the amount of vitamin D3 in the higher dose of FOSAVANCE) once weekly was demonstrated in a 24-week, extension study that enrolled 619 osteoporotic post-menopausal women.
U 24-tjednom nastavku ispitivanja koje je uključilo 619 žena u postmenopauzi s osteoporozom dokazan je učinak niže doze lijeka FOSAVANCE (alendronat 70 mg/vitamin D3 2800 IU) uz dodatak 2800 IU vitamina D3, što čini ukupno 5600 IU (količina vitamina D3 u višoj dozi lijeka FOSAVANCE)
200 ml), so that FOSAVANCE is adequately absorbed.
kako bi se FOSAVANCE pravilno apsorbirao.
FOSAVANCE 70 mg/2,800 IU tablets alendronic acid/colecalciferol
FOSAVANCE 70 mg/2800 IU tablete alendronatna kiselina/kolekalciferol
FOSAVANCE 70 mg/5,600 IU tablets alendronic acid /colecalciferol
FOSAVANCE 70 mg/5600 IU tablete alendronatna kiselina/kolekalciferol
It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of FOSAVANCE if taken at the same time.
Uzmete li FOSAVANCE istodobno s nadomjescima kalcija, antacidima i nekim lijekovima koji se uzimaju kroz usta, oni će vjerojatno utjecati na njegovu apsorpciju.
Strength Pharmaceutical Form
Doza Farmaceutski oblik Put primjene Pakovanje
Very rare, not known*
Vrlo rijetko, nepoznato*
It may be given with or without food.
Može se uzimati uz obrok ili bez obroka.
• Adults and elderly
• Odrasli i starije osobe
• if you have had an allergy or reaction to any medicine used to treat your disease.
• Ako ste imali alergiju ili reakciju na bilo koji lijek koji ste koristili za liječenje Vaše bolesti.
Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Odmah morate kontaktirati liječnika ili najbliži odjel hitne medicinske pomoći zbog povećanog rizika od krvarenja.
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
You should check with your doctor or pharmacist if you are not sure.
Provjerite sa svojimliječnikom ili ljekarnikom ako niste sigurni.
• You should tell your doctor if a surgery (including dental) is planned.
• Obavijestite svog liječnika ako planirate kirurški zahvat (uključujući stomatološke zahvate).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 September 2009
Datum prvog odobrenja: 21. rujna 2009.
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 je učestalost definirana na sljedeći način: česte (≥1/100, <1/10); manje česte (≥1/1000, <1/100); rijetke (≥1/10 000, <1/1000); vrlo rijetke (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
Children and adolescents Do not give this medicine to children because it does not work.
Nemojte dati ovaj lijek djeci jer ne djeluje.
You should take Clopidogrel dura for as long as your doctor continues to prescribe it.
Clopidogrel dura trebate uzimati sve dok Vam ga liječnik propisuje.
Clopidogrel is indicated in:
Klopidogrel je indiciran u:
Clinical efficacy and safety
Klinička djelotvornost i sigurnost primjene
• if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days
• Ako ste imali krvni ugrušak u arteriji u mozgu (ishemijski moždani udar) koji se pojavio unutar posljednjih sedam dana.
What Clopidogrel dura is and what it is used for What you need to know before you take Clopidogrel dura
Što je Clopidogrel dura i za što se koristi Što morate znati prije nego počnete uzmati Clopidogrel dura
What you need to know before you take Clopidogrel Dura
Što morate znati prije nego počnete uzimati Clopidogrel dura
Since the CAPRIE trial was not powered to evaluate efficacy of individual subgroups, it is not clear whether the differences in relative risk reduction across qualifying conditions are real, or a result of chance.
Kako kliničko ispitivanje CAPRIE nije za cilj imalo procijeniti djelotvornost u pojedinačnim podskupinama, nije jasno jesu li razlike relativnog smanjenja rizika unutar podskupina stvarne ili su slučajan rezultat.).
What Clopidogrel Dura is and what it is used for
Što je Clopidogrel dura i za što se koristi
Prevention of atherothrombotic events
Prevencija aterotrombotičkih događaja
Date of latest renewal:
Datum zadnje revizije:
In COMMIT, the overall rate of noncerebral major bleeding or cerebral bleeding was low and similar in both groups
U studiji COMMIT, ukupna stopa necerebralnog velikog krvarenja ili cerebralnog krvarenja bila je niska i slična u obje skupine.
Some other medicines may influence the use of Clopidogrel dura or vice versa.
Neki lijekovi mogu utjecati na djelovanje lijeka Clopidogrel dura i obratno.
Other medicines and Clopidogrel Dura
Drugi lijekovi i Clopidogrel dura
The elimination half life of the main circulating (inactive) metabolite was 8 hours after single and repeated administration.
Poluvijek eliminacije glavnog cirkulirajućeg (neaktivnog) metabolita iznosio je 8 sati nakon jednokratne i ponovljene primjene.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Moguće nuspojave Kao i svi drugi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakog.
An occasional use of acetylsalicylic acid (no more than 1000 mg in any 24 hour period), a substance present in many medicines used to relieve pain and lower fever, should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.
Povremeno uzimanje acetilsalicilatne kiseline (ne više od 1000 mg u 24 sata), tvari koja je prisutna u mnogim lijekovima za olakšavanje bolova i blage vrućice, općenito ne izaziva probleme, ali o produljenom uzimanju u drugim okolnostima morate razgovarati s liječnikom.
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.
Clopidogrel dura contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Clopidogrel dura sadrži klopidogrel i pripada skupini lijekova koji se nazivaju antitrombocitni lijekovi.
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.
Ostali lijekovi: Određeni broj ostalih kliničkih studija provodio se s klopidogrelom i nekim drugim istodobno primjenjivanim lijekovima kako bi se ispitala mogućnost farmakodinamičkih i farmakokinetičkih interakcija.
• if you suffer from severe liver disease;
• ako patite od teške bolesti jetre.
Detailed information is available on the European Medicines Agency website: http://www.ema.europa.eu.
Detaljnije informacije dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu..
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem:nacionalnog sustava prijave nuspojava navedenog u Dodatku V.
• Your doctor may order blood tests.
• Vaš liječnik će možda odrediti da Vam se naprave pretrage krvi.
• Active pathological bleeding such as peptic ulcer or intracranial haemorrhage.
• Aktivno patološko krvarenje, poput peptičkog ulkusa ili intrakranijalnog krvarenja.
What Clopidogrel dura contains
Što Clopidogrel dura sadrži
If you take more Clopidogrel dura than you should:
Ako uzmete više lijeka Clopidogrel dura nego što ste trebali:
Recent myocardial infarction (MI), recent stroke or established peripheral arterial disease
Nedavni infarkt miokarda (MI), nedavni moždani udar ili utvrđena bolest perifernih arterija
Patients with a confirmed diagnosis of acquired haemophilia should be managed and treated by specialists, and clopidogrel should be discontinued.
Bolesnike s potvrđenom dijagnozom stečene hemofilije trebaju liječiti i tretirati specijalisti, a primjenu klopidogrela treba prekinuti.
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.
Međutim, postoji veći broj retrospektivnih analiza za procjenu ovog učinka u bolesnika liječenih klopidogrelom za koje postoje rezultati genotipizacije: CURE (n=2721), CHARISMA (n=2428), CLARITY-TIMI 28 (n=227), TRITON-TIMI 38 (n=1477) te ACTIVE-A (n=601), kao i određeni broj objavljenih kohortnih kliničkih studija.
Patients who had developed a previous allergic reaction and/or haematological reaction to one thienopyridine may have an increased risk of developing the same or another reaction to another thienopyridine.
U bolesnika u kojih se prethodno razvila alergijska reakcija i/ili hematološka reakcija na jedan tienopiridin moguć je veći rizik od jednake ili drugačije reakcije na drugi tienopiridin.
Blister of OPA/Al/PVC-Al containing 7, 14, 28, 30, 50, 56, 84, 90 and 100 film-coated tablets in the box.
Blister od OPA/Al/PVC-Al koji sadrži 7, 14, 28, 30, 50, 56, 84, 90 i 100 filmom obloženih tableta u kutiji.
Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excl. heparin, ATC code: B01AC04.
Farmakoterapijska skupina: Antitrombocitni agensi, inhibitori agregacije trombocita izuzev heparina, ATK oznaka: B01AC04.
• If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Ako se porežete ili ozlijedite, može trajati dulje nego obično da krvarenje prestane.
As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel dura.
Kao mjera opreza, treba prestati s dojenjem za vrijeme liječenja lijekom Clopidogrel dura.
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.
Nakon oralne doze klopidogrela obilježenog s 14C u ljudi, približno 50% doze izlučilo se u mokraću, a približno 46% u stolicu u intervalu od 120 sati nakon doziranja.
Boxes of 7, 14, 28, 30, 50, 56, 84, 90 and 100 film-coated tablets in blisters are available.
Dostupne su kutije sa 7, 14, 28, 30, 50, 56, 84, 90 i 100 filmom obloženih tableta u blisteru.
This leaflet was last revised in MM/YYYY.
Uputa je zadnji puta revidirana u <mjesec/GGGG>.
If you forget to take a dose of Clopidogrel dura, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Ako zaboravite uzeti jednu dozu lijeka Clopidogrel dura, ali se toga sjetite u roku od 12 sati, odmah uzmite tabletu, a sljedeću tabletu uzmite u uobičajeno vrijeme.
• if you have kidney or liver disease.
• Ako imate bolest bubrega ili jetre.
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.
Sigurnost i djelotvornost klopidogrela procijenjena je u četiri dvostrukoslijepe studije koje su uključivale preko 80 000 bolesnika: studija CAPRIE, u kojoj se uspoređivao klopidogrel i ASK te CURE, CLARITY, COMMIT, u kojima se uspoređivalo djelovanje klopidogrela s placebom, a obje su 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").
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).
Nije bilo dokaza o karcinogenim učincima kad se klopidogrel davao miševima 78 tjedana i štakorima 104 tjedna u dozama do 77 mg/kg dnevno (što predstavlja barem 25 puta veću izloženost nego u ljudi koji primaju kliničku dozu od 75 mg/dan).
However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Warnings and precautions').
Ukoliko ste ipak zabrinuti zbog krvarenja, odmah obavijestite svog liječnika (vidjeti dio 2. "Upozorenja i mjere opreza").
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru nakon "Rok valjanosti".
If you are breast-feeding or planning to breastfeed, talk to your doctor before taking this medicine.
Ako dojite ili planirate dojiti, razgovarajte sa svojim liječnikom prije uzimanja ovog lijeka.
Thienopyridines may cause mild to severe allergic reactions such as rash, angioedema, or haematological cross-reactions such as thrombocytopaenia and neutropaenia.
Tienopiridini mogu izazvati blage do teških alergijskih reakcija, kao što su osip, angioedem, ili hematološke križne reakcije, kao što su trombocitopenija i neutropenija.
NAME OF THE MARKETING AUTHORISATION HOLDER Mylan dura GmbH
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Mylan dura GmbH
You have been prescribed Clopidogrel dura to help prevent blood clots and reduce the risk of these severe events because: - 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
Vam je propisan za sprječavanje stvaranja krvnih ugrušaka i smanjivanje opasnosti od ovih ozbiljnih događaja jer: - 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.
If you become pregnant while taking Clopidogrel dura, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Ako zatrudnite za vrijeme uzimanja lijeka Clopidogrel dura, odmah se posavjetujte s liječnikom, jer nije preporučeno uzimati klopidogrel za vrijeme trudnoće.
In CURE, CLARITY and one of the cohort studies (Trenk), no increased event rate was observed based on metaboliser status.
U studijama CURE, CLARITY i jednoj od kohortnih studija (Trenk), nije uočena povećana stopa događaja temeljena na metabolizatorskom statusu.
Driving and using machines
Upravljanje vozilima i strojevima:
At steady state, the average inhibition level observed with a dose of 75 mg per day was between 40% and
U stanju dinamičke ravnoteže prosječna opažena razina inhibicije, uz dozu od 75 mg dnevno, iznosi između 40% i 60%.
The incidence of major bleeding was similar between groups.
Incidencija velikih krvarenja bila je slična u obje skupine.
If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel dura:
Ako se na Vas odnosi bilo koje od dolje navedenih stanja morate obavijestiti liječnika prije nego što uzmete Clopidogrel dura:
Clopidogrel should not be used in children because of efficacy concerns (see section 5.1).
Pedijatrijska populacija Klopidogrel se ne primjenjuje u djece zbog nedovoljnih podataka o djelotvornosti (vidjeti dio 5.1).
Name and address of the manufacturer(s) responsible for batch release
Naziv i adresa proizvođača odgovornog (odgovornih) za puštanje serije lijeka u promet
Clopidogrel dura is unlikely to affect your ability to drive or to use machines.
Clopidogrel dura ne bi trebao utjecati na Vašu sposobnost upravljanja vozilima ili strojevima.
Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172) Talc
polivinilni alkohol titanijev dioksid (E171) željezov oksid, crveni (E172) žuti željezov oksid (E172) talk makrogol 3000 (polietilenglikol)
• Adults patients suffering from myocardial infarction (from a few days until less than 35 days),
• odraslih bolesnika koji su pretrpjeli infarkt miokarda (u rasponu od nekoliko do najviše
The usual dose is one 75 mg tablet of Clopidogrel dura per day to be taken orally with or without food, and at the same time each day.
Uobičajena doza lijeka Clopidogrel dura je jedna tableta od 75 mg dnevno koja se uzima kroz usta s obrokom ili između obroka, u isto vrijeme svaki dan.
Clopidogrel dura 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).
Clopidogrel dura uzimaju odrasli za sprječavanje stvaranja krvnih ugrušaka (tromba) u otvrdnutim krvnim žilama (arterijama), a taj poremećaj zove se aterotromboza i može dovesti do aterotrombotičkih događaja (kao što su moždani udar, srčani udar ili smrt).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER BLISTER
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel dura.
Ako ste trudni ili sumnjate na trudnoću, obavjestite svog liječnika ili ljekarnika prije nego što uzmete Clopidogrel dura.
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 of food.
Vrlo rijetke nuspojave (mogu se javiti u manje od 1 na 10 000 osoba): žutica; jaka bol u trbuhu s 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 hrane.
The active substance is clopidogrel.
Djelatna tvar je klopidogrel.
Because the active metabolite is formed by CYP450 enzymes, some of which are polymorphic or subject to inhibition by medicinal products, not all patients will have adequate platelet inhibition.
S obzirom da aktivni metabolit nastaje putem enzima CYP450, od kojih su neki polimorfni ili podložni inhibiciji od strane lijekova, neće svi bolesnici iskusiti odgovarajuću inhibiciju trombocita.
Patients should be evaluated for history of hypersensitivity to thienopyridines (such as clopidogrel, ticlopidine, prasugrel) since cross-reactivity among thienopyridines has been reported (see section 4.8).
U bolesnika je potrebno provjeriti anamnezu preosjetljivosti na tienopiridine (kao što su klopidogrel, tiklopidin, prasugrel) jer je zabilježena križna reaktivnost među tienopiridinima (vidjeti dio 4.8).