natgillin/translations-raw huggingface dataset:
For the 7, 14, 28 and 84 tablets pack sizes, you can check the day on which you last took a tablet of clopidogrel by referring to the calendar printed on the blister.
Na koledarčku, ki je natisnjen na pretisnem omotu pri pakiranjih po 7, 14, 28 in 84 tablet, lahko preverite, kateri dan ste zadnjič vzeli tableto klopidogrela.
Like all medicines, Clopidogrel BMS can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Clopidogrel BMS neželene učinke, ki pa se ne pojavijo pri
- fever, signs of infection or extreme tiredness.
- zvišana telesna temperatura, znaki okužbe ali huda utrujenost.
These may be due to rare decrease of some
To so lahko znaki redkega
blood cells.
zmanjšanja števila določenih krvnih celic,
- signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or
- znaki jetrnih težav, kot je porumenelost kože in/ ali oči (zlatenica), ki so lahko, ali pa ne, povezani
not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see ‘Take special care with Clopidogrel BMS’).
s krvavitvijo, ki se pojavi pod kožo kot drobne rdeče pike, in/ ali zmedenostjo (glejte Bodite posebno pozorni pri jemanju zdravila Clopidogrel BMS).
These
To so lahko znaki
may be the signs of an allergic reaction.
alergijske reakcije.
The most common side effect (affects 1 to 10 patients in 100) reported with clopidogrel is bleeding.
Najpogostejši neželeni učinek (pojavi se pri 1 do 10 od 100 bolnikov), o katerem so poročali s klopidogrelom je krvavitev.
However, if you are concerned by your bleeding, you should contact your doctor straightaway (see ‘Take special care with Clopidogrel BMS’).
Vendar pa se morate takoj posvetovati s svojim zdravnikom, če ste glede krvavitve v kakršnihkoli dvomih (glejte Bodite posebno pozorni pri jemanju zdravila Clopidogrel BMS).
Other side effects reported with clopidogrel are:
Drugi neželeni učinki, o katerih so poročali s klopidogrelom so:
Common side effects (affects 1 to 10 patients in 100):
Pogosti neželeni učinki (pojavijo se pri 1 do 10 od 100 bolnikov):
Diarrhoea, abdominal pain, indigestion or heartburn.
Driska, bolečina v trebuhu, slaba prebava ali zgaga.
Uncommon side effects (affects 1 to 10 patients in 1,000):
Občasni neželeni učinki (pojavijo se pri 1 do 10 od 1. 000 bolnikov):
Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, abnormal touch sensation.
Glavobol, razjeda na želodcu, bruhanje, slabost, zaprtost, preveč plinov v želodcu ali črevesju, izpuščaji, srbenje, omotica, nenormalen občutek za dotik.
Rare side effect (affects 1 to 10 patients in 10,000):
Redki neželeni učinki (pojavijo se pri 1 do 10 od 10. 000 bolnikov):
Vertigo.
Vrtoglavica.
Very rare side effects (affects less than 1 patient in 10,000): jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions; swelling in the mouth; blisters of the skin; skin allergy; inflammation of the mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; taste disorders.
Zelo redki neželeni učinki (pojavijo se pri manj kot 1 od 10. 000 bolnikov): zlatenica, huda bolečina v trebuhu z ali brez bolečine v hrbtu, zvišana telesna temperatura, težave pri dihanju, ki so včasih povezane s kašljem, splošne alergijske reakcije, oteklina v ustih, mehurji na koži, kožna alergija, vnetje v ustih (stomatitis), znižanje krvnega tlaka, zmedenost, halucinacije, bolečine v sklepih, bolečine v mišicah, motnje okusa.
Do not use clopidogrel after the expiry date which is stated on the carton and on the blister.
Ne uporabljajte klopidogrela po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu.
If Clopidogrel BMS is supplied in PVC/PVDC/aluminium blisters, store below 30°C.
Zdravilo Clopidogrel BMS, ki je na voljo v PVC/ PVDC/ alu pretisnih omotih, shranjujte pri temperaturi do 30°C.
40 Medicines should not be disposed of via wastewater or household waste.
40 Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
What Clopidogrel BMS contains The active substance is clopidogrel.
Kaj vsebuje zdravilo Clopidogrel BMS
The other ingredients are mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000 and low-substituted hydroxypropylcellulose in the tablet core, and lactose (milk sugar), hypromellose (E464), triacetin (E1518), red iron oxide (E172), titanium dioxide (E171), and carnauba wax in the tablet coating.
Pomožne snovi so: manitol (E421), hidrogenirano ricinusovo olje, mikrokristalna celuloza, makrogol 6000 in nizkosubstituirana hidroksipropilceluloza v jedru tablete in laktoza (mlečni sladkor), hipromeloza (E464), triacetin (E1518), rdeč železov oksid (E172), titanov dioksid (E171) in karnauba vosek v oblogi tablete.
Clopidogrel BMS 75-mg tablets are round, biconvex, pink, film-coated tablets engraved on one side with the number ‘75’ and on the other side with the number ‘1171’.
Clopidogrel BMS 75 mg tablete so okrogle, bikonveksne filmsko obložene tablete, rožnate barve, z vtisnjeno številko “ 75 ” na eni strani in številko “ 1171 ” na drugi strani.
They are supplied in cardboard cartons containing 7, 14, 28, 30, 84, 90 and 100 tablets in PVC/PVDC/Aluminium blisters or in all aluminium blisters, or 50x1 tablets in PVC/PVDC/Aluminium blisters or in all aluminium perforated unit-dose blisters.
Na voljo so v škatlah, ki vsebujejo 7, 14, 28, 30, 84, 90 in 100 tablet v PVC/ PVDC/ alu pretisnih omotih ali v pretisnih omotih iz aluminija, ali 50x1 tableta v PVC/ PVDC aluminijastih pretisnih omotih ali v aluminijastih perforiranih pretisnih omotih za enkratni odmerek.
Sanofi Winthrop Industrie 1, rue de la Vierge, Ambarès & Lagrave, F-33565 Carbon Blanc cedex, France and/or Sanofi-Synthelabo Limited, Edgefield Avenue, Fawdon Newcastle Upon Tyne, Tyne & Wear NE3 3TT - UK, United Kingdom and/or Sanofi Winthrop Industrie 6, boulevard de l'Europe, F-21800 Quétigny, France
Sanofi Winthrop Industrie 1, Rue de la Vierge, Ambarès & Lagrave, F- 33565 Carbon Blanc cedex, Francija in/ ali Sanofi - Synthelabo Limited, Edgefield Avenue, Fawdon Newcastle Upon Tyne, Tyne & Wear NE3 3TT – UK, Velika Britanija in/ ali Sanofi Winthrop Industrie 6, Boulevard de l’ Europe, F- 21800 Quétigny, Francija
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
41 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
41 Česká republika BRISTOL-MYERS SQUIBB SPOL.
Malta Česká republika BRISTOL- MYERS SQUIBB S. R. L.
Deutschland BRISTOL-MYERS SQUIBB GMBH & CO.
KGAA
KGAA Tel: + 49 89 121 42-0
Tel: + 49 89 121 42- 0
Norge BRISTOL-MYERS SQUIBB NORWAY LTD Tlf: + 47 67 55 53 50
Tlf: + 47 67 55 53 50
Ísland VI STOR HF Sími: + 354 535 7000
Ísland VISTOR HF
Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε.Π.Ε.
42 Κύπρος ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε. Π. Ε.
Latvija BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT.
Latvija BRISTOL- MYERS SQUIBB
United Kingdom BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTD Tel: + 44 (0800) 731 1736
Tel: + 44 (0800) 731 1736
42 This leaflet was last approved in MM/YYYY
Navodilo je bilo odobreno MM/ LLLL
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http://www.emea.europa.eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http: // www. emea. europa. eu /.
43 PACKAGE LEAFLET:
43 NAVODILO ZA UPORABO
Clopidogrel BMS 300 -mg film-coated tablets clopidogrel
Clopidogrel BMS 300 mg filmsko obložene tablete klopidogrel
• If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel BMS; • If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain; • If you suffer from severe liver disease.
- če ste alergični na (preobčutljivi za) klopidogrel ali katerokoli sestavino zdravila Clopidogrel
44 If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking clopidogrel.
- če imate zdravstveno stanje, ki trenutno povzroča krvavitev, kot je rana na želodcu ali krvavitev v
Take special care with Clopidogrel BMS:
možganih;
- a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer)
- če imate hudo jetrno obolenje.
-
Če menite, da se karkoli od navedenega nanaša na vas, ali če ste kakorkoli v dvomih, se posvetujte s svojim zdravnikom, preden boste vzeli klopidogrel.
a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
Če katerokoli od spodaj navedenih stanj velja za vas, morate o tem obvestiti svojega zdravnika, preden boste vzeli klopidogrel: • če imate tveganje za krvavitev, kot je:
- - -
- zdravstveno stanje s tveganjem za notranjo krvavitev (kot je rana na želodcu)
a recent serious injury a recent surgery (including dental) a planned surgery (including dental) in the next seven days
- krvna motnja, zaradi katere ste bolj nagnjeni k notranji krvavitvi (krvavitev v tkivih, organih ali
•
- nedavna huda poškodba
if
- nedaven kirurški poseg (vključno na zobeh)
you have had a clot in an artery of your brain (ischemic stroke) which occurred within the last
- načrtovan kirurški poseg (vključno na zobeh) v naslednjih 7 dneh
seven days • if you are taking another type of medicine (see ‘Taking other medicines’). • if you have kidney or liver disease
• če ste imeli strdek v možganski arteriji (ishemična kap), ki se je pojavil v zadnjih sedmih dneh • če jemljete druge vrste zdravil (glejte “ Jemanje drugih zdravil ”) • če imate ledvične ali jetrne bolezni
While you are taking Clopidogrel BMS: • You should tell your doctor if a surgery (including dental) is planned. • You should also tell your doctor immediately if you develop a medical condition 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 ‘POSSIBLE SIDE EFFECTS’). • If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Ko jemljete zdravilo Clopidogrel BMS: • morate povedati zdravniku, če imate predvideno kakšno operacijo (vključno z zobozdravstvenim posegom). • morate takoj povedati zdravniku, če razvijete bolezensko stanje z vročino in modricami pod kožo, ki se lahko pojavijo kot drobne rdeče pike, z ali brez nerazložljive hude utrujenosti, zmedenosti, porumenele kože ali oči (zlatenica) (glejte MOŽNI NEŽELENI UČINKI). • se lahko krvavitev ustavi počasneje kot ponavadi, če se urežete ali poškodujete.
Clopidogrel is not intended for use in children or adolescents.
Klopidogrel ni namenjeno za uporabo pri otrocih ali mladostnikih.
The use of oral anticoagulants (medicines used to reduce blood clotting) with clopidogrel is not recommended.
Uporaba peroralnih antikoagulantov (zdravil, ki se uporabljajo za zmanjševanje strjevanja krvi) s klopidogrelom ni priporočljiva.
You should specifically tell your doctor if you take a non-steroidal anti-inflammatory drug, usually used to treat painful and/or inflammatory conditions of muscle or joints, or if you take heparin or any other medicine used to reduce blood clotting.
Še posebej pomembno je, da obvestite svojega zdravnika, če jemljete nesteroidna protivnetna zdravila, ki se običajno uporabljajo za lajšanje bolečine in/ ali vnetja mišic ali sklepov, ali če jemljete heparin ali katerokoli drugo zdravilo, ki se uporablja za zmanjševanje strjevanja krvi.
45 Pregnancy and breast-feeding It is preferable not to use this product during pregnancy and breast-feeding.
Če ste noseči ali mislite, da ste noseči, morate o tem obvestiti svojega zdravnika ali farmacevta, preden 45 vzamete klopidogrel.
If you become pregnant while taking clopidogrel, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Če med zdravljenjem s klopidogrelom zanosite, se takoj posvetujte s svojim zdravnikom, saj jemanje klopidogrela med nosečnostjo ni priporočljivo.
Then, the usual dose is one 75 mg tablet of Clopidogrel BMS per day to be taken orally with or without food, and at the same time each day.
Nato je običajni odmerek ena 75- mg tableta zdravila Clopidogrel BMS na dan, ki jo lahko vzamete s hrano ali brez nje; odmerek morate jemati vsak dan ob istem času.
- signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or
- znaki jetrnih težav, kot je porumenelost kože in/ ali oči (zlatenica), ki so lahko, ali pa ne,
not associated with bleeding which appears under the skin as red pinpoint dots, and/or confusion (see ‘Take special care with Clopidogrel BMS’).
povezani s krvavitvijo, ki se pojavi pod kožo kot drobne rdeče pike, in/ ali zmedenostjo (glejte Bodite posebno pozorni pri jemanju zdravila Clopidogrel BMS).
Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual
Krvavitve se lahko pojavijo kot krvavitve iz želodca ali črevesja, kot modrice, hematomi (neobičajne krvavitve ali modrice pod kožo), krvavitev iz nosu, kri v urinu.
In a small number of cases, bleeding in the eye, inside the head, the lung or the joints has also been reported.
46 Če doživite podaljšanje krvavitve v času jemanja zdravila Clopidogrel BMS Če se urežete ali poškodujete, lahko traja dlje kot običajno, da se vam krvavitev ustavi.
Do not use clopidogrel if you notice any visible sign of deterioration.
Ne uporabljajte klopidogrela, če ste opazili vidne znake kvarjenja.
47 What Clopidogrel BMS looks like and contents of the pack
47 Izgled zdravila Clopidogrel BMS in vsebina pakiranja
Clopidogrel BMS 300-mg tablets are oblong, pink, film-coated tablets engraved on one side with the number ‘300’ and on the other side with the number ‘1332’.
Clopidogrel BMS 300 mg tablete so podolgovate, rožnate, filmsko obložene tablete, z vtisnjeno številko “ 300 ” na eni strani in številko “ 1332 ” na drugi strani.
They are supplied in cardboard cartons containing 4x1, 30x1 and 100x1 tablets in all aluminium perforated unit-dose blisters.
Na voljo so v škatlah, ki vsebujejo 4x1, 30x1 in 100x1 tableto v perforiranih pretisnih omotih za enkratni odmerek, ki so v celoti iz aluminija.
Sanofi Winthrop Industrie 1, rue de la Vierge, Ambarès & Lagrave, F-33565 Carbon Blanc cedex, France
Sanofi Winthrop Industrie 1, Rue de la Vierge, Ambarès & Lagrave, F- 33565 Carbon Blanc cedex, Francija
48 España BRISTOL-MYERS SQUIBB, S.A.
48 España BRISTOL- MYERS SQUIBB, S. A.
This leaflet was last approved in MM/YYYY
Navodilo je bilo odobreno MM/ LLLL
What is Clopidogrel Winthrop?
Kaj je zdravilo Clopidogrel Winthrop?
Clopidogrel Winthrop is a medicine that contains the active substance clopidogrel.
Clopidogrel Winthrop je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
This medicine is the same as Plavix, which is already authorised in the European Union (EU).
To zdravilo je enako zdravilu Plavix, ki je že odobreno v Evropski uniji (EU).
The company that makes Plavix has agreed that its scientific data can be used for Clopidogrel Winthrop.
Družba, ki proizvaja zdravilo Plavix, je dovolila, da se lahko znanstveni podatki tega zdravila uporabijo tudi za zdravilo Clopidogrel Winthrop.
What is Clopidogrel Winthrop used for?
Za kaj se zdravilo Clopidogrel Winthrop uporablja?
Clopidogrel Winthrop is used in adult patients to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Zdravilo Clopidogrel Winthrop se uporablja pri odraslih bolnikih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdevanje krvnih žil).
Clopidogrel Winthrop can be given to the following groups of patients: • patients who have recently had a myocardial infarction (heart attack).
Zdravilo Clopidogrel Winthrop se lahko daje naslednjim skupinam bolnikov: • bolnikom, ki so nedavno imeli miokardni infarkt (srčni napad).
Clopidogrel Winthrop can be started between a few days and 35 days after the attack; • patients who have had a recent ischaemic stroke (non-bleeding stroke).
Jemanje zdravila Clopidogrel Winthrop je mogoče začeti nekaj dni po napadu in do 35 dni po njem; • bolnikom, ki so nedavno imeli ishemično kap (kap zaradi žilne zapore).
Clopidogrel Winthrop can be started between seven days and six months after the attack; • patients with peripheral arterial disease (problems with blood flow in the arteries); • patients who have a condition known as ‘ acute coronary syndrome ’, when it should be given in combination with aspirin (another anticoagulant), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up).
Jemanje zdravila Clopidogrel Winthrop je mogoče začeti v sedmih dneh po napadu in do šest mesecev po njem; • bolnikom s periferno arterijsko boleznijo (težavami s pretokom krvi v arterijah); • bolnikom z akutnim koronarnim sindromom, pri kateri se mora zdravilo dajati skupaj z aspirinom (drugim antikoagulantom), vključno z bolniki, katerim je bil vstavljen stent (kratka cevka, nameščena v arteriji, da prepreči njeno zapiranje).
Clopidogrel Winthrop can be used in patients who are having a heart attack with an ‘ ST segment elevation’ (an abnormal reading on the electrocardiogram or ECG) when the doctor thinks that they would benefit from the treatment.
Zdravilo Clopidogrel Winthrop se lahko uporablja pri bolnikih, ki so imeli srčni napad z „ elevacijo spojnice ST “ (nenormalni zapis na elektrokardiogramu ali EKG), če bi zdravnik menil, da bi jim zdravilo lahko pomagalo.
How is Clopidogrel Winthrop used?
Kako se zdravilo Clopidogrel Winthrop uporablja?
The standard dose of Clopidogrel Winthrop is one 75 mg tablet once a day, taken with or without food.
Običajni odmerek zdravila Clopidogrel Winthrop je ena 75- miligramska tableta enkrat na dan, vzeta s hrano ali brez nje.
In acute coronary syndrome, Clopidogrel Winthrop is used together with aspirin (another anticoagulant) and treatment generally starts with a loading dose of one 300 mg tablet or four 75 mg tablets.
Temu sledi običajni 75- miligramski
How does Clopidogrel Winthrop work?
Kako zdravilo Clopidogrel Winthrop deluje?
The active substance in Clopidogrel Winthrop, clopidogrel, is an inhibitor of platelet aggregation.
Zdravilna učinkovina v zdravilu Clopidogrel Winthrop, klopidogrel, je zaviralec agregacije trombocitov.
How has Clopidogrel Winthrop been studied?
Kako je bilo zdravilo Clopidogrel Winthrop raziskano?
The effectiveness of Clopidogrel Winthrop as an anticoagulant was compared with that of aspirin in a study called CAPRIE including around 19,000 patients with atherothrombosis.
Učinkovitost zdravila Clopidogrel Winthrop kot antikoagulanta so v okviru študije, imenovane CAPRIE, v katero je bilo vključenih 19. 000 bolnikov z aterotrombozo, primerjali z učinkovitostjo aspirina.
In non-ST segment elevation acute coronary syndrome, Clopidogrel Winthrop was compared with placebo (a dummy treatment) in over 12,000 patients for up to a year (CURE study):
Pri zdravljenju akutnega koronarnega sindroma brez elevacije spojnice ST so zdravilo Clopidogrel Winthrop primerjali s placebom (zdravilom brez zdravilne učinkovine) pri več kot 12. 000 bolnikov, zdravljenih do enega leta (študija CURE):
In ST segment elevation myocardial infarction, Clopidogrel Winthrop was compared with placebo in two studies:
Pri zdravljenju miokardnega infarkta z elevacijo spojnice ST so zdravilo Clopidogrel Winthrop primerjali s placebom v dveh študijah:
CLARITY (over 3,000 patients, where the patients received Clopidogrel Winthrop for up to eight days) and COMMIT (almost 46,000 patients, where the patients received Clopidogrel Winthrop with or without metoprolol for up to four weeks).
CLARITY (ki je vključevala več kot 3000 bolnikov, ki so do osem dni prejemali zdravilo Clopidogrel Winthrop) in COMMIT (ki je vključevala skoraj 46. 000 bolnikov, ki so do štiri tedne prejemali zdravilo Clopidogrel Winthrop z metoprololom ali brez njega).
What benefit has Clopidogrel Winthrop shown during the studies?
Kakšne koristi je zdravilo Clopidogrel Winthrop izkazalo med študijami?
Clopidogrel Winthrop was more effective than aspirin at preventing new ischaemic events.
Zdravilo Clopidogrel Winthrop je bilo pri preprečevanju novih ishemičnih dogodkov učinkovitejše od aspirina.
There were 939 events in the Clopidogrel Winthrop group, and 1,020 in the aspirin group.
V skupini, ki je prejemala zdravilo Clopidogrel Winthrop, je bilo 939 dogodkov, v skupini, zdravljeni z aspirinom, pa 1020.
Risk reduction means that fewer patients will have new ischaemic events when they receive Clopidogrel Winthrop, than if they receive aspirin.
Zmanjšanje tveganja pomeni, da bo manj bolnikov doživelo nov ishemični napad, če bodo prejemali zdravilo Clopidogrel Winthrop, kot pa če bodo prejemali aspirin.
In other words, about 10 patients in 1,000 will avoid having a new ischaemic event two years after starting Clopidogrel Winthrop instead of aspirin.
Z drugimi besedami, približno 10 bolnikov od 1000 se bo izognilo novemu ishemičnemu napadu v dveh letih po pričetku prejemanja zdravila Clopidogrel Winthrop namesto aspirina.
In ST segment elevation myocardial infarction, fewer patients on Clopidogrel Winthrop had events than patients on placebo (262 against 377 in the CLARITY study, and 2,121 against 2,310 in the COMMIT study).
Pri miokardnem infarktu z elevacijo spojnice ST je bilo število bolnikov, pri katerih so se pojavili dogodki, manjše med bolniki, ki so jemali zdravilo Clopidogrel Winthrop, kot med bolniki, ki so prejemali placebo (262 v primerjavi s 377 v študiji CLARITY ter 2121 v primerjavi z 2310 v študiji COMMIT).
This showed that Clopidogrel Winthrop reduces the risk of an event.
To je dokaz, da zdravilo Clopidogrel Winthrop znižuje tveganje za pojav dogodka.
What is the risk associated with Clopidogrel Winthrop?
Kakšna tveganja so povezana z zdravilom Clopidogrel Winthrop?
The most common side effects with Clopidogrel Winthrop (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal (tummy) pain, dyspepsia (indigestion), bruising and bleeding where the skin is punctured.
Najpogostejši neželeni učinki zdravila Clopidogrel Winthrop (opaženi pri 1 do 10 bolnikih izmed 100) so hematomi (kopičenje krvi pod kožo), epistaksa (krvavitve iz nosu), gastrointestinalna hemoragija (krvavitve v želodcu ali črevesju), bolečine v trebuhu, dispepsija (slaba prebava), podplutbe in krvavitve na mestu predrte kože.
For the full list of all side effects reported with Clopidogrel Winthrop, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Clopidogrel Winthrop, glejte navodilo za uporabo.
Clopidogrel Winthrop should not be used in people who may be hypersensitive (allergic) to clopidogrel or any of the other ingredients, or in patients who have severe liver disease, or have a disease which may cause bleeding.
Zdravila Clopidogrel Winthrop ne smejo uporabljati osebe, ki utegnejo biti preobčutljivi za (alergične na) klopidogrel ali katero koli drugo sestavino zdravila, imajo hudo jetrno obolenje ali imajo bolezen, ki lahko povzroči krvavenje.
Why has Clopidogrel Winthrop been approved?
Zakaj je bilo zdravilo Clopidogrel Winthrop odobreno?
The Committee for Medicinal Products for Human Use (CHMP) decided that Clopidogrel Winthrop’ s benefits are greater than its risks in adults for the prevention of atherothrombotic events.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Clopidogrel Winthrop za bolnike, pri katerih obstaja nevarnost aterotrombotičnih dogodkov, večje od z njim povezanih tveganj.
The Committee recommended that Clopidogrel Winthrop be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Clopidogrel Winthrop odobri dovoljenje za promet.
Other information about Clopidogrel Winthrop:
2/ 3 Druge informacije o zdravilu Clopidogrel Winthrop: