natgillin/translations-raw huggingface dataset:
Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, sofosbuvir/velpatasvir and lopinavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Povećane koncentracije tenofovira u plazmi uslijed istovremene primjene tenofovirdizoproksila, sofosbuvira/velpatasvira i lopinavira/ritonavira mogu pojačati nuspojave vezane uz tenofovirdizoproksil, uključujući poremećaje bubrega.
Cmax: ↑ 55% (↑ 41 to ↑ 71) Cmin: ↑ 301% (↑ 257 to
AUC: ↑ 142% (↑ 123 do ↑ 164) Cmax: ↑ 55% (↑ 41 do ↑ 71) Cmin: ↑ 301% (↑ 257 do ↑ 350)
asthenia
Doziranje
(n = 1251)
Emtricitabin/tenofovirdizoproksil (n = 1251)
pain, asthenia
bol, astenija
rash
osip
Transmission of HIV
Prijenos HIV-a
Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, sofosbuvir/velpatasvir and atazanavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Povećane koncentracije tenofovira u plazmi uslijed istovremene primjene tenofovirdizoproksila, sofosbuvira/velpatasvira i atazanavira/ritonavira mogu pojačati nuspojave vezane uz tenofovirdizoproksil, uključujući poremećaje bubrega.
Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, sofosbuvir/velpatasvir/voxilaprevir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Povećane koncentracije tenofovira u plazmi uslijed istovremene primjene tenofovirdizoproksila, sofosbuvira/velpatasvira/voksila previra i darunavira/ritonavira mogu pojačati nuspojave vezane uz tenofovirdizoproksil, uključujući poremećaje bubrega.
Blister packs
Blister
• Talk to your doctor if you are intolerant to lactose (see Emtricitabine/Tenofovir disoproxil Mylan contains lactose later in this section).
• Ako ne podnosite laktozu, razgovarajte s liječnikom (pogledajte niže u ovom dijelu,
Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, sofosbuvir/velpatasvir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Povećane koncentracije tenofovira u plazmi uslijed istovremene primjene tenofovirdizoproksila, sofosbuvira/velpatasvira i darunavira/ritonavira mogu pojačati nuspojave vezane uz tenofovirdizoproksil, uključujući poremećaje bubrega.
Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, ledipasvir/sofosbuvir and atazanavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Povećane koncentracije tenofovira u plazmi uslijed istovremene primjene tenofovirdizoproksila, ledipasvira/sofosbuvira i atazanavira/ritonavira mogu pojačati nuspojave vezane uz tenofovirdizoproksil, uključujući poremećaje bubrega.
Adefovir dipivoxil:
Adefovirdipivoksil:
Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, ledipasvir/sofosbuvir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Povećane koncentracije tenofovira u plazmi uslijed istovremene primjene tenofovirdizoproksila, ledipasvira/sofosbuvira i darunavira/ritonavira mogu pojačati nuspojave vezane uz tenofovirdizoproksil, uključujući poremećaje bubrega.
Rilpivirine: AUC: ↔ Cmax: ↔ Cmin: ↔
Rilpivirin: AUC: ↔ Cmax: ↔ Cmin: ↔
METHOD AND ROUTE OF ADMINISTRATION
5. NAČIN I PUT PRIMJENE LIJEKA
(may affect up to 1 in 1,000 people) • Lactic acidosis (see Possible serious side effects)
• laktacidoza (pogledajte Moguće ozbiljne nuspojave)
Elderly
astenija
Emtricitabine/Tenofovir disoproxil Mylan is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, (see sections 4.2, 4.4 and 5.1).
Emtricitabin/tenofovirdizoproksil Mylan također je indiciran za liječenje adolescenata koji su zaraženi virusom HIV-1, s rezistencijom na nukleozidne inhibitore reverzne transkriptaze (engl.
Gastrointestinal disorders:
Predekspozicijska profilaksa:
+ Emtricitabine/Rilpivirine/ Tenofovir disoproxil (200 mg/25 mg/245 mg q.d.)
Ledipasvir/sofosbuvir (90 mg/400 mg q.d.) + emtricitabin/rilpivirin/ tenofovirdizoproksil (200 mg/25 mg/245 mg q.d.)
Strength Pharmaceutical Form
Jačina Farmaceutski oblik
Immediate Packaging Content (concentration)
Put primjene Unutarnje pakiranje Sadržaj (koncentracija)
MA (EU) Number (Invented) name
Broj (EU) odobrenja
1 pre-filled pen
1 napunjena brizgalica
1 pre-filled syringe pre-filled syringe (glass) in pre-filled pen
napunjena štrcaljka (staklo) u napunjenoj brizgalici
Pack size pre-filled syringe (glass) 1 ml (30 mg/ml)
Veličina pakiranja napunjena štrcaljka (staklo)
2 years.
3 godine.
It may harm them, even if their symptoms are the same as yours.
Može im naškoditi, čak i ako su njihovi znakovi bolesti jednaki Vašima.
The patients were followed for 30 days.
Bolesnici su praćeni 30 dana.
The expiry date refers to the last day of that month.
Rok valjanosti odnosi se na posljednji dan navedenog mjeseca.
Do not take a double dose to make up for a forgotten tablet dose.
Ne uzimajte dvostruku dozu kako biste nadoknadili zaboravljenu tabletu.
These measures will help to protect the environment.
Ove će mjere pomoći će u očuvanju okoliša.
The optimal duration of treatment has not been formally established.
Optimalno trajanje liječenja još formalno nije utvrđeno.
Thus, the results from this subset are in line with the overall trial results.
Prema tome, rezultati iz te podskupine su u skladu s cjelokupnim rezultatima ispitivanja.
In addition, clinical tolerance was good in all patients.
Osim toga, klinička podnošljivost bila je dobra u svih bolesnika.
OTHER SPECIAL WARNING(S), IF NECESSARY
DRUGO (A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO
Combined therapy should be started as early as possible after symptoms start and continued for at least four weeks.
Kombinirano liječenje treba započeti što je ranije moguće nakon pojave simptoma i nastaviti kroz najmanje 4 tjedna.
The clinical relevance of this interaction is uncertain.
Klinički značaj ove interakcije nije jasan.
You should check with your doctor or pharmacist if you are not sure.
Provjerite sa svojim liječnikom ili ljekarnikom ako niste sigurni.
• Adults and elderly
Odrasli i starije osobe
PACKAGE LEAFLET: INFORMATION FOR THE USER
Uputa o lijeku: Informacija za korisnika
Keep out of the reach and sight of children.
Čuvati izvan pogleda i dohvata djece.
In addition, your doctor may identify changes in your blood or urine test results.
Također, Vaš liječnik može naći promjene u nalazima krvi ili urina.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzimali neke druge lijekove, uključujući i one koje ste nabavili bez recepta.
For further information please refer to section 5.1.
Za dodatne informacije vidjeti dio 5.1.
In this leaflet:
Što se nalazi u ovoj uputi:
TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
TTP je potencijalno fatalno stanje koje zahtijeva hitno liječenje uključujući i plazmaferezu.
Store in the original package in order to protect from moisture and light.
Čuvati u originalnom pakiranju radi zaštite od vlage i svjetlosti.
The patient population included 19.7% women and 29.2% patients ≥65 years.
Populacija bolesnika uključivala je 19,7% žena i 29,2% bolesnika ≥65 godina.
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).
Ispitivanja na životinjama ne ukazuju na izravne ili neizravne štetne učinke na trudnoću, embrionalni/fetalni razvoj, porođaj ili postnatalni razvoj (vidjeti dio 5.3.).
During non clinical studies in rat and baboon, the most frequently observed effects were liver changes.
Tijekom nekliničkih ispitivanja na štakorima i babunima, najčešće zabilježeni učinci bile su promjene na jetri.
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 cilj kliničkog ispitivanja CAPRIE nije bio procijeniti djelotvornost u pojedinačnim podskupinama, nije jasno jesu li razlike relativnog smanjenja rizika unutar podskupina stvarne ili su slučajan rezultat.
An occasional use of acetylsalicylic acid (no more than 1,000 mg in any 24 hour period) 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) općenito ne izaziva probleme, ali o produljenom uzimanju u drugim okolnostima morate razgovarati s liječnikom.
This is linked to the way your medicine works as it prevents the ability of blood clots to form.
To je povezano s načinom na koji lijek djeluje, jer spriječava mogućnost stvaranja krvnih ugrušaka.
Patients were treated for up to one year.
Bolesnici su bili liječeni do 5 godina.
Proton Pump Inhibitors (PPI):
Inhibitori protonske pumpe (IPP):
In view of the lack of data, clopidogrel cannot be recommended during the first 7 days after acute ischaemic stroke.
S obzirom da nema podataka, klopidogrel se ne preporučuje tijekom prvih 7 dana nakon akutnog ishemijskog moždanog udara.
Patients should inform physicians and dentists that they are taking clopidogrel before any surgery is scheduled and before any new medicinal product is taken.
Bolesnici moraju obavijestiti liječnika i stomatologa o uzimanju klopidogrela prije planiranja bilo kakvog kirurškog zahvata i prije uzimanja bilo kojeg novog lijeka.
For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow.
Za liječenje tog stanja liječnik Vam može ugraditi stent (potpornicu) u začepljenu ili suženu arteriju da bi ponovno uspostavio učinkovit protok krvi.
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, Nizozemska
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.
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu/
The mean bleeding time prolongation was also similar in the two groups.
Srednje produljenje vremena krvarenja također je bilo slično u obje skupine.
• You should tell your doctor if a surgery (including dental) is planned
Obavijestite svog liječnika ako planirate kirurški zahvat (uključujući stomatološke zahvate).
• 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.
PHARMACEUTICAL FORM Film-coated tablet.
Filmom obložena tableta.
If you take more Clopidogrel Teva Generics B.V. than you should Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Ako uzmete više tableta Klopidogrel Teva Generics B.V. nego što ste trebali Odmah se morate javiti liječniku ili u najbliži odjel hitne medicinske pomoći zbog povećanog rizika od krvarenja.
Pharmacovigilance system
Farmakovigilancijski sustav
However, due to the lack of interaction studies with other NSAIDs it is presently unclear whether there is an increased risk of gastrointestinal bleeding with all NSAIDs.
Međutim, zbog nepostojanja studija u kojima se prati interakcija s drugim lijekovima iz skupine NSAIL za sada nije jasno odnosi li se povećani rizik od gastrointestinalnog krvarenja na sve nesteroidne protuupalne lijekove.
Since higher doses of ASA were associated with higher bleeding risk it is recommended that the dose of ASA should not be higher than 100 mg.
Budući da se više doze acetilsalicilne kiseline povezuju s visokim rizikom od krvarenja, preporučuje se da doza ASK ne bude veća od 100 mg.
However, clopidogrel and ASA have been administered together for up to one year (see section 5.1).
Međutim, klopidogrel i ASK istodobno su primjenjivani u trajanju do jedne godine (vidjeti dio 5.1.).
Cytochrome P450 2C19 (CYP2C19)
Citokrom P450 2C19 (CYP2C19)
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, primjenu klopidogrela treba prekinuti 7 dana prije zahvata.
In patients suffering from acute coronary syndrome:
Bolesnici s akutnim koronarnim sindromom:
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
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).
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.
Dodatno, analiza podskupina prema dobi ukazuje da je korist od liječenja klopidogrelom manja u bolesnika iznad 75 godina nego u onih ≤75 godina.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder
Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje u gotovog lijeka u promet:
Taking Clopidogrel Teva Generics B.V. with food and drink Clopidogrel Teva Generics B.V. may be taken with or without food.
Klopidogrel Teva Generics B.V. s hranom i pićem Klopidogrel Teva Generics B.V može se uzimati s obrokom ili bez obroka.
For a full list of excipients, see section 6.1.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
Ask your doctor or pharmacist for advice before taking any medicine.
Obratite se svom liječniku ili ljekarniku za savjet prije nego što uzmete bilo koji lijek.
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 koji su dobiveni u različitim populacijama (primjerice, nestabilna angina ili non-Q infarkt miokarda, niska do visoka razina rizika, šećerna bolest, potreba revaskularizacije, dob, spol itd.) bili su sukladni rezultatima primarne analize.
From literature, limited data in Asian populations are available to assess the clinical implication of genotyping of this CYP on clinical outcome events.
U literaturi su dostupni ograničeni podaci za procjenu kliničke implikacije genotipizacije ovog CYP enzima na ishode kliničkih događaja u azijatskoj populaciji.
When given to lactating rats, clopidogrel caused a slight delay in the development of the offspring.
Kad se davao ženkama štakora u vrijeme dojenja, klopidogrel je izazivao neznatno kašnjenje u razvitku mladunčadi.
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.
Bolesnike treba pomno nadzirati radi mogućih znakova krvarenja, uključujući okultno krvarenje, i to poglavito tijekom prvih tjedana liječenja i/ili nakon invazivnih kardioloških postupaka ili kirurških zahvata.
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.
If you forget to take a dose of Clopidogrel Teva Generics B.V., 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 Klopidogrel Teva Generics B.V. ali se toga sjetite u roku od 12 sati, odmah uzmite tabletu, a sljedeću tabletu uzmite u uobičajeno vrijeme.
Thrombotic Thrombocytopenic Purpura (TTP) has been reported very rarely following the use of clopidogrel, sometimes after a short exposure.
Trombotična trombocitopenična purpura (TTP) zabilježena je vrlo rijetko nakon primjene klopidogrela, katkad nakon kratke izloženosti lijeku.
At steady state, the average inhibition level observed with a dose of 75 mg per day was between 40% and 60%.
U stanju dinamičke ravnoteže prosječna opažena razina inhibicije, uz dozu od 75 mg na dan, iznosi između 40% i 60%.
After single and repeated oral doses of 75 mg per day, clopidogrel is rapidly absorbed.
Nakon jednokratne i ponovljenih oralnih doza od 75 mg na dan, klopidogrel se brzo apsorbira.
Platelet aggregation and bleeding time gradually returned to baseline values, generally within 5 days after treatment was discontinued.
Agregacija trombocita i vrijeme krvarenja postupno se vraćaju na početne vrijednosti, obično unutar 5 dana od prekida uzimanja lijeka.
Hallucinations, confusion
Psihijatrijski poremećaji halucinacije, konfuznost
Clopidogrel has been tested in a range of in vitro and in vivo genotoxicity studies, and showed no genotoxic activity.
Klopidogrel je testiran u mnogim genotoksičnim studijama in vivo i in vitro i nije pokazao genotoksičnu aktivnost.
By preventing this clumping, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis).
Sprječavanjem tog nakupljanja, antitrombocitni lijekovi smanjuju mogućnost stvaranja krvnih ugrušaka (proces zvan tromboza).
Marketing Authorisation Holder Teva Generics B.V., Computerweg 10, 3542 DR Utrecht, The Netherlands
Nositelj odobrenja za stavljanje gotovog lijeka u promet Teva Generics B.V., Computerweg 10, 3542 DR Utrecht, Nizozemska
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (28x1 film-coated tablets-calendar pack)
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP (BLISTER 28x1 filmom obloženih tableta-kalendarsko pakiranje)
The population included 27.8% women, 58.4% patients ≥60 years (26% ≥70 years) and 54.5% patients who received fibrinolytics.
Populacija bolesnika uključivala je 27,8% žena, 58,4% bolesnika ≥60 godina (26% ≥70 godina) i 54,5% bolesnika koji su primali fibrinolitike.
There was no observed effect on the rate of rehospitalisation for unstable angina.
Nije primijećen učinak na ponovljenu hospitalizaciju zbog nestabilne angine.
Clopidogrel and the main circulating (inactive) metabolite bind reversibly in vitro to human plasma proteins (98% and 94% respectively).
Klopidogrel i glavni cirkulirajući (neaktivni) metabolit reverzibilno se in vitro vežu za proteine u ljudskoj plazmi (98% odnosno 94%).
Clopidogrel prolongs bleeding time and should be used with caution in patients who have lesions with a propensity to bleed (particularly gastrointestinal and intraocular).
Klopidogrel produljuje vrijeme krvarenja i mora se davati s oprezom bolesnicima koji imaju lezije s mogućnošću krvarenja (osobito gastrointestinalne i intraokularne).
Clopidogrel was found to have no effect on the fertility of male and female rats and was not teratogenic in either rats or rabbits.
Klopidogrel nije imao štetnih učinaka na fertilitet muških i ženskih štakora i nije pokazao teratogene učinke na štakorima i kunićima.
The binding is non-saturable in vitro over a wide concentration range.
Vezanje nije zasićeno in vitro u širokom rasponu koncentracija.
• Active pathological bleeding such as peptic ulcer or intracranial haemorrhage.
Aktivno patološko krvarenje, poput peptičkog ulkusa ili intrakranijalnog krvarenja.
The MAH must ensure that the system of pharmacovigilance, as described in version version 8 dated November 2009 presented in Module 1.8.1. of the Marketing Authorisation Application, 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. nositelja odobrenja, ustrojen i funkcionalan prije i za vrijeme dok je lijek na tržištu.
Manufacturer
Proizvođači
Some other medicines may influence the use of Clopidogrel Teva Generics B.V. or vice versa.
Neki lijekovi mogu utjecati na djelovanje Klopidogrel Teva Generics B.V. i obratno.
Recent myocardial infarction (MI), recent stroke or established peripheral arterial disease
Nedavni infarkt miokarda (IM), nedavni moždani udar ili utvrđena bolest perifernih arterija
The co-primary endpoints were death from any cause and the first occurrence of re-infarction, stroke or death.
Uz koprimarni ishod bila je povezana smrt iz bilo kojeg uzroka i prvi ponovljeni infarkt, moždani udar ili smrt.
If you cut or injure yourself, it may take slightly longer than usual for bleeding to stop.
Ako se porežete ili ozlijedite, može trajati dulje nego obično da krvarenje prestane.
Pharmacotherapeutic group: platelet aggregation inhibitors excl. heparin, ATC code: B01AC-04.
5.1 Farmakodinamička svojstva Farmakoterapijska skupina: inhibitori agregacije trombocita izuzev heparina, ATK oznaka: B01AC04.
The benefit of the combination of clopidogrel with ASA beyond four weeks has not been studied in this setting (see section 5.1).
Korist kombinacije klopidogrela s ASK u trajanju dužem od 4 tjedna nije ispitivana u ovom stanju (vidjeti dio 5.1.).
Specific pharmacokinetic studies performed with radiolabelled clopidogrel have shown that the parent compound or its metabolites are excreted in the milk.
Specifične farmakokinetičke studije provođene s radioaktivno označenim klopidogrelom pokazale su da se izvorna tvar ili njezini metaboliti izlučuju u mlijeko.
In CAPRIE, in patients treated with either clopidogrel or ASA, the overall incidence of any bleeding was 9.3%.
U studiji CAPRIE, u bolesnika koji su liječeni klopidogrelom ili ASK, ukupna incidencija bilo kakvog krvarenja iznosila je 9,3%.
Due to the risk of bleeding and haematological adverse reactions, blood cell count determination and/or other appropriate testing should be promptly considered whenever clinical symptoms suggestive of bleeding arise during the course of treatment (see section 4.8).
Zbog opasnosti od krvarenja i hematoloških nuspojava, potrebno je odmah provjeriti krvnu sliku i/ili druge relevantne nalaze kad god se tijekom liječenja pojave klinički znakovi koji ukazuju na krvarenje (vidjeti dio 4.8.).
Moreover, the safety profile of clopidogrel in this subgroup of patients did not raise any particular concern.
Osim toga, sigurnosni profil klopidogrela nije u toj podskupini bolesnika izazvao bilo kakvu zabrinutost.
Apart from the specific medicinal product interaction information described above, interaction studies with clopidogrel and some medicinal products commonly administered in patients with atherothrombotic disease have not been performed.
Osim prethodno opisanih interakcija sa specifičnim lijekovima, nisu provedena ispitivanja interakcija klopidogrela s nekim lijekovima koji se obično propisuju bolesnicima s aterotrombotskom bolesti.
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 44 000 bolesnika koji su sudjelovali u kliničkim ispitivanjima, uključujući više od 12 000 bolesnika koji su lijek primali godinu ili više dana.