FrancophonIA/ELRC3.0 huggingface dataset:
English: Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Desloratadine Actavis.
Croatian: Vezano za trajanje liječenja, Vaš će liječnik odrediti od kojeg tipa alergijskog rinitisa bolujete te koliko dugo trebate uzimati Desloratadin Actavis.
English: • restlessness with increased body movement
Croatian: • nemir s pojačanim pokretima tijela
English: An improvement in pruritus of more than 50% was observed in 55% of patients treated with desloratadine compared with 19% of patients treated with placebo.
Croatian: Zabilježeno je smanjenje pruritusa za više od 50% kod 55% bolesnika liječenih desloratadinom, u usporedbi sa 19% bolesnika koji su primali placebo.
English: These include inhibiting the release of pro-inflammatory cytokines such as IL-4, IL-6, IL-8, and IL-13 from human mast cells/basophils, as well as inhibition of the expression of the adhesion molecule P-selectin on endothelial cells.
Croatian: Ova svojstva uključuju inhibiciju otpuštanja proinflamatornih citokina poput IL-4, IL-6, IL-8 i IL-13 iz ljudskih mastocita/bazofila, kao i inhibiciju ekspresije adhezijske molekule P-selektina na endotelnim stanicama.
English: A. Potamitis Medicare Ltd
Croatian: Potamitis Medicare Ltd
English: How to store Desloratadine Actavis Contents of the pack and other information
Croatian: Kako čuvati Desloratadin Actavis Sadržaj pakiranja i druge informacije
English: 7 film-coated tablets 10 film-coated tablets 14 film-coated tablets 20 film-coated tablets 21 film-coated tablets 30 film-coated tablets 50 film-coated tablets 90 film-coated tablets 100 film-coated tablets
Croatian: 7 filmom obloženih tableta 10 filmom obloženih tableta 14 filmom obloženih tableta 20 filmom obloženih tableta 21 filmom obložena tableta 30 filmom obloženih tableta 50 filmom obloženih tableta 90 filmom obloženih tableta 100 filmom obloženih tableta
English: The safety and efficacy of Desloratadine Actavis 5 mg film-coated tablets in children below the age of 12 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka Desloratadin Actavis 5 mg filmom obložene tablete u djece mlađe od 12 godina nisu ustanovljene.
English: Desloratadine Actavis 5 mg film-coated tablets are packed in: Blister packs: 7, 10, 14, 20, 21, 30, 50, 90 or 100 tablets.
Croatian: Desloratadin Actavis 5 mg filmom obložene tablete dostupne su u: blister pakiranjima: 7, 10, 14, 20, 21, 30, 50, 90 ili 100 tableta.
English: In clinical studies with desloratadine, the following side effects were reported as: Common: the following may affect up to 1 in 10 people
Croatian: U kliničkim ispitivanjima s desloratadinom, sljedeće nuspojave bile su prijavljene kao: Česte: sljedeće nuspojave mogu se javiti u do 1 na 10 osoba
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000
Croatian: Učestalost pojavljivanja definirana je kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i <
English: What you need to know before you take Desloratadine Actavis
Croatian: Što morate znati prije nego počnete uzimati Desloratadin Actavis
English: In the case of severe renal insufficiency, desloratadine should be used with caution (see section 5.2).
Croatian: U slučaju teške insuficijencije bubrega, desloratadin treba oprezno primjenjivati (vidjeti dio 5.2).
English: SN: {number}
Croatian: SN: {broj} [serijalizacijski broj]
English: METHOD AND ROUTE(S) OF ADMINISTRATION Swallow the tablet whole with water.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Tabletu progutati cijelu s vodom.
English: Polyethylene bottles containing a desiccant and closed with a polyethylene cap.
Croatian: Polietilen boce sadrže sredstvo za sušenje i zatvorene su sa zatvaračem od polietilena.
English: Talk to your doctor, pharmacist or nurse before taking Desloratadine Actavis:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Desloratadin Actavis. - ako imate oslabljenu funkciju bubrega.
English: In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, desloratadine was effective in relieving pruritus and decreasing the size and number of hives by the end of the first dosing interval.
Croatian: U dva placebom kontrolirana ispitivanja u trajanju od šest tjedana u bolesnika s kroničnom idiopatskom urtikarijom desloratadin je učinkovito ublažavao pruritus i smanjivao veličinu i broj koprivnjača do kraja prvog intervala doziranja.
English: In a clinical trial with 578 adolescent patients, 12 through 17 years of age, the most common adverse event was headache; this occurred in 5.9 % of patients treated with desloratadine and 6.9 % of patients receiving placebo.
Croatian: U kliničkom ispitivanju s 578 ispitanika adolescenata, u dobi od 12 do 17 godina, najčešći štetni događaj bila je glavobolja koja se javljala u 5,9% bolesnika liječenih desloratadinom i u 6,9%
English: Desloratadine was effective in alleviating the burden of seasonal allergic rhinitis as shown by the total score of the rhino-conjunctivitis quality of life questionnaire.
Croatian: Desloratadin je bio učinkovit u ublažavanju simptoma sezonskog alergijskog rinitisa, što se vidi iz ukupnog rezultata upitnika o kvaliteti života ispitanika s rinokonjunktivitisom.
English: Use caution when taking Desloratadine Actavis with alcohol.
Croatian: Potreban je oprez kada se Desloratadin Actavis uzima s alkoholom.
English: At the recommended dose, this medicine is not expected to affect your ability to drive or use machines.
Croatian: Ako se uzme u preporučenoj dozi, ovaj lijek ne bi trebao utjecati na Vašu sposobnost upravljanja vozilima ili rada sa strojevima.
English: Desloratadine Actavis is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with: - allergic rhinitis (see section 5.1) - urticaria (see section 5.1)
Croatian: Desloratadin Actavis je indiciran u odraslih i adolescenata u dobi od 12 ili više godina za ublažavanje simptoma povezanih s: - alergijskim rinitisom (vidjeti dio 5.1) - urtikarijom (vidjeti dio 5.1)
English: Desloratadine has demonstrated anti-allergic properties from in vitro studies.
Croatian: Desloratadin je pokazao antialergijska svojstva u in vitro ispitivanjima.
English: Desloratadine Actavis relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults and adolescents 12 years of age and older.
Croatian: Desloratadin Actavis ublažava simptome povezane s alergijskim rinitisom (upala nosnih puteva uzrokovana alergijom, na primjer, kod peludne groznice ili alergije na grinje) u odraslih osoba i adolescenata u dobi od 12 ili više godina.
English: Tablet coating: Hypromellose 6cP, titanium dioxide (E171), macrogol 6000, indigo carmine aluminum lake (E132).
Croatian: Ovojnica tablete: hipromeloza 6cP, titanijev dioksid (E171), makrogol 6000, indigo carmine aluminium lake (E132).
English: What Desloratadine Actavis is and what it is used for
Croatian: Što je Desloratadin Actavis i za što se koristi
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/745/010 30 film-coated tablets EU/1/11/745/011 100 film-coated tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/745/010 30 filmom obloženih tableta EU/1/11/745/011 100 filmom obloženih tableta
English: In a pharmacokinetic trial in which patient demographics were comparable to those of the general seasonal allergic rhinitis population, 4% of the subjects achieved a higher concentration of desloratadine.
Croatian: U farmakokinetičkom ispitivanju u kojem su demografski podaci ispitanika bili usporedivi s podacima opće populacije koja je imala sezonski alergijski rinitis, 4% ispitanika imalo je višu koncentraciju desloratadina.
English: • liver inflammation • abnormal liver function tests
Croatian: • odstupanja od normalnih rezultata testova jetrene funkcije
English: • pounding or irregular heartbeat
Croatian: • lupanje ili nepravilni otkucaji srca
English: Desloratadine Actavis is an antiallergy medicine that does not make you drowsy.
Croatian: Desloratadin Actavis je lijek protiv alergije koji ne izaziva pospanost.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13.01.2012
Croatian: Datum prvog odobrenja: 13. 01. 2012.
English: In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with desloratadine were reported in 3% of patients in excess of those treated with placebo.
Croatian: U kliničkim ispitivanjima kod različitih indikacija, uključujući alergijski rinitis i kroničnu idiopatsku urtikariju, pri preporučenoj dozi od 5 mg na dan, kod primjene desloratadina prijavljene su nuspojave u 3% više bolesnika nego u onih koji su primali placebo.
English: Desloratadine Actavis is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Croatian: Desloratadin Actavis se također koristi za ublažavanje simptoma povezanih s urtikarijom (promjene na koži uslijed alergije).
English: What Desloratadine Actavis looks like and contents of the pack Blue coloured, round, with diameter of 6 mm, biconvex, film-coated tablets with the marking ‘LT' engraved on one side.
Croatian: Kako Desloratadin Actavis izgleda i sadržaj pakiranja Plave, okrugle, bikonveksne filmom obložene tablete promjera 6 mm s utisnutom oznakom „LT“ na jednoj strani.
English: In a clinical pharmacology trial, desloratadine tablets taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
Croatian: U kliničkom farmakološkom ispitivanju, uzimanje desloratadin tableta istodobno s alkoholom nije pojačalo štetne učinke alkohola na ponašanje (vidjeti dio 5.1).
English: • upset stomach
Croatian: • bol u želucu
English: What Desloratadine Actavis is Desloratadine Actavis contains desloratadine which is an antihistamine.
Croatian: Što je Desloratadin Actavis Desloratadin Actavis sadrži desloratadin, koji je antihistaminik.
English: In a single dose trial using a 7.5 mg dose of desloratadine, there was no effect of food (high-fat, high caloric breakfast) on the disposition of desloratadine.
Croatian: U kliničkom ispitivanju pojedinačne doze desloratadina u dozi od 7,5 mg nije bilo utjecaja hrane (visokokalorični doručak, s visokim udjelom masti) na raspoloživost desloratadina.
English: Other undesirable effects reported during the post-marketing period in paediatric patients with an unknown frequency included QT prolongation, arrhythmia, bradycardia, abnormal behaviour, and aggression.
Croatian: Ostale nuspojave nepoznate učestalosti prijavljene u pedijatrijskih bolesnika nakon stavljanja lijeka u promet uključivale su produljenje QT intervala, aritmiju i bradikardiju, neuobičajeno ponašanje i agresiju.
English: EU/1/11/745/001 7 film-coated tablets EU/1/11/745/002 10 film-coated tablets EU/1/11/745/003 14 film-coated tablets EU/1/11/745/004 20 film-coated tablets EU/1/11/745/005 21 film-coated tablets EU/1/11/745/006 30 film-coated tablets EU/1/11/745/007 50 film-coated tablets EU/1/11/745/008 90 film-coated tablets EU/1/11/745/009 100 film-coated tablets
Croatian: EU/1/11/745/001 7 filmom obloženih tableta EU/1/11/745/002 10 filmom obloženih tableta EU/1/11/745/003 14 filmom obloženih tableta EU/1/11/745/004 20 filmom obloženih tableta EU/1/11/745/005 21 filmom obložena tableta EU/1/11/745/006 30 filmom obloženih tableta EU/1/11/745/007 50 filmom obloženih tableta EU/1/11/745/008 90 filmom obloženih tableta EU/1/11/745/009 100 filmom obloženih tableta
English: What Desloratadine Actavis contains - The active substance is desloratadine.
Croatian: Što Desloratadin Actavis sadrži - Djelatna tvar je desloratadin.
English: This medicine does not require any special temperature storage conditions.
Croatian: Ovaj lijek ne zahtijeva posebne uvjete čuvanja na određenoj temperaturi.
English: Blue coloured, round, with diameter of 6 mm, biconvex, film-coated tablets with the marking ‘LT' engraved on one side.
Croatian: Plave, okrugle, bikonveksne filmom obložene tablete promjera 6 mm s utisnutom oznakom „LT“ na jednoj strani.
English: INFORMATION IN BRAILLE desloratadine actavis 5 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU desloratadin actavis 5 mg
English: If you forget to take Desloratadine Actavis
Croatian: Ako ste zaboravili uzeti Desloratadin Actavis
English: - The other ingredients are: Tablet core: Microcrystalline cellulose, starch (pregelatinised), mannitol, talc, magnesium stearate.
Croatian: Jezgra tablete: mikrokristalična celuloza, škrob (prethodno geliran), manitol, talk, magnezijev stearat.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE CARTON
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S BOCOM
English: Adults and adolescents 12 years of age and over The recommended dose is one tablet once a day with water, with or without food.
Croatian: Preporučena doza je jedna tableta jedanput na dan, a uzima se s vodom, uz obrok ili natašte.
English: Each film-coated tablet (tablet) contains 5 mg desloratadine.
Croatian: Jedna filmom obložena tableta (tableta) sadrži 5 mg desloratadina.
English: Other medicines and Desloratadine Actavis There are no known interactions of Desloratadine Actavis with other medicines.
Croatian: Nema poznatih interakcija između lijeka Desloratadin Actavis i drugih lijekova.
English: Tell your pharmacist if you notice any change in the appearance of the tablets.
Croatian: Ako uočite bilo kakvu promjenu u izgledu tableta obratite se svom ljekarniku.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BLISTER CARTON
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S BLISTEROM
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Croatian: Ova uputa je zadnji puta revidirana u MM/GGGG Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: Microcrystalline cellulose Starch, pregelatinised Mannitol
Croatian: celuloza, mikrokristalična škrob, prethodno geliran manitol talk magnezijev stearat
English: ● increased appetite
Croatian: • povećana tjelesna težina • povećan apetit
English: During the marketing of desloratadine, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely.
Croatian: piskanje pri disanju, svrbež, koprivnjača i oticanje) bili su prijavljeni vrlo rijetko.
English: Islande
Croatian: Island
English: How to take Desloratadine Actavis
Croatian: Kako uzimati Desloratadin Actavis
English: Blisters: This medicine does not require any special storage conditions.
Croatian: Ovaj lijek ne zahtijeva posebne uvjete čuvanja.
English: Desloratadine Actavis 5 mg film-coated tablets desloratadine
Croatian: Desloratadin Actavis 5 mg filmom obložene tablete desloratadin
English: NAME OF THE MEDICINAL PRODUCT Desloratadine Actavis 5 mg tablets desloratadine
Croatian: NAZIV LIJEKA Desloratadin Actavis 5 mg tablete desloratadin
English: How Desloratadine Actavis works
Croatian: Kako djeluje Desloratadin Actavis
English: Titanium dioxide (E171) Macrogol 6000
Croatian: Ovojnica tablete: hipromeloza 6cP titanijev dioksid (E171) makrogol 6000 indigo carmine aluminium lake (E132)
English: When Desloratadine Actavis should be used
Croatian: Kada treba uzimati Desloratadin Actavis
English: During the marketing of desloratadine, the following side effects were reported as: Very rare: the following may affect up to 1 in 10,000 people
Croatian: Vrlo rijetke: sljedeće nuspojave mogu se javiti u do 1 na 10 000 osoba
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva vrlo rijetko mijalgija
English: How to store Desloratadine Actavis
Croatian: Kako čuvati Desloratadin Actavis
English: NAME OF THE MEDICINAL PRODUCT Desloratadine Actavis 5 mg film-coated tablets
Croatian: NAZIV LIJEKA Desloratadin Actavis 5 mg filmom obložene tablete
English: • stomach ache
Croatian: • upala jetre
English: If you stop taking Desloratadine Actavis If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
English: NAME OF THE MARKETING AUTHORISATION HOLDER [Actavis Group PTC ehf.
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET [Actavis Group PTC ehf. Logo]
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [Actavis Group PTC ehf.
Croatian: 11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET [Actavis Group PTC ehf. Logo]
English: • muscle pain
Croatian: • omaglica
English: • slow heartbeat
Croatian: • želučane tegobe • proljev
English: However, if you take more Desloratadine Actavis than you were told to, tell your doctor, pharmacist or nurse immediately.
Croatian: Vam je propisano, odmah o tome obavijestite svog liječnika, ljekarnika ili medicinsku sestru.
English: Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea
Croatian: Poremećaji probavnog sustava često vrlo rijetko suha usta bol u abdomenu, mučnina, povraćanje,
English: Both active substances have been available in the EU for a number of years.
Croatian: Obje djelatne tvari dostupne su u EU-u već godinama.
English: It can be used in the following groups of patients who have a condition known as ‘acute coronary syndrome':
Croatian: Može se primjenjivati u sljedećim skupinama bolesnika koji boluju od „akutnog koronarnog sindroma”:
English: • patients being treated for heart attack with ST-segment elevation, when the doctor thinks that they would benefit from thrombolytic treatment (treatment to dissolve blood clots).
Croatian: • bolesnika koji se liječe zbog srčanog udara s elevacijom ST segmenta, kad liječnik smatra da bi mogli imati koristi od trombolitičke terapije (terapije kojom se razgrađuju krvni ugrušci).
English: The medicine is available as tablets containing 75 mg clopidogrel, either with 75 mg or 100 mg acetylsalicylic acid and can only be obtained with a prescription.
Croatian: Lijek je dostupan u obliku tableta koje sadrže 75 mg klopidogrela, sa 75 mg ili sa 100 mg acetilsalicilne kiseline te se izdaje samo na recept.
English: Clopidogrel has been authorised since 1998 as an antiplatelet medicine, and is often used in combination with acetylsalicylic acid.
Croatian: Klopidogrel je od 1998. odobren kao antitrombocitni lijek te se često koristi u kombinaciji s acetilsalicilnom kiselinom.
English: Further information on Clopidogrel/Acetylsalicylic acid Mylan can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/clopidogrel-acetylsalicylic-acid-mylan.
Croatian: Više informacija o lijeku Clopidogrel/Acetylsalicylic acid Mylan dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/clopidogrel-acetylsalicylic-acid-mylan.
English: The combination of the two active substances reduces the risk of blood clots forming more than either medicine alone.
Croatian: Kombinacija tih dviju djelatnih tvari smanjuje rizik od stvaranja krvnih ugrušaka više nego svaka od njih pojedinačno.
English: • patients who have unstable angina (a severe type of chest pain) or who have had a heart attack with no ‘ST-segment elevation' (an abnormal reading on an electrocardiogram), including those who are having a stent (a short tube) inserted into an artery to prevent it from closing up;
Croatian: • u bolesnika s nestabilnom anginom (teškim oblikom boli u prsima) ili onih koji su prebolili srčani udar bez elevacije ST segmenta (abnormalni nalaz elektrokardiograma), uključujući osobe koje imaju stent (kratku cjevčicu) ugrađenu u arteriju da se spriječi njeno začepljenje;
English: The medicine is taken as one tablet once a day instead of the clopidogrel and acetylsalicylic acid tablets that the patient has already been taking separately.
Croatian: Lijek se uzima kao jedna tableta jednom dnevno umjesto tableta klopidogrela i acetilsalicilne kiseline koje je bolesnik prethodno zasebno uzimao.
English: Clopidogrel blocks a substance called ADP from attaching to a receptor (target) on the surface of platelets.
Croatian: Clopidogrel blokira vezanje tvari pod nazivom ADP za receptor (cilj) na površini trombocita.
English: This means that they help to prevent components in the blood called platelets from sticking together and forming clots, thus helping to prevent another heart attack.
Croatian: To znači da pomažu spriječiti međusobno lijepljenje komponenti u krvi pod nazivom trombociti i stvaranje ugrušaka, čime se suzbija novi srčani udar.
English: Studies on the benefits and risks of the active substances in the authorised uses have already been carried out with the reference medicine, DuoPlavin, and do not need to be repeated for Clopidogrel/Acetylsalicylic acid Mylan.
Croatian: Ispitivanja koristi i rizika od djelatnih tvari u odobrenoj primjeni već su provedena s referentnim lijekom DuoPlavin i stoga ih nije potrebno ponavljati za Clopidogrel/Acetylsalicylic acid Mylan.
English: This reduces the production of a substance called thromboxane, which normally helps clots to form by attaching platelets together.
Croatian: Time se smanjuje proizvodnja tvari naziva tromboksan, koji u pravilu pomaže pri formiranju ugrušaka spajanjem trombocita.
English: Both active substances in the medicine, clopidogrel and acetylsalicylic acid, are antiplatelet medicines.
Croatian: Obje djelatne tvari u lijeku, klopidogrel i acetilsalicilna kiselina su antitrombocitni lijekovi.
English: Side effects reported with Clopidogrel/Acetylsalicylic acid Mylan are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Clopidogrel/Acetylsalicylic acid Mylan pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Clopidogrel/Acetylsalicylic acid Mylan is a medicine used to prevent problems caused by blood clots and hardening of the arteries, such as a heart attack, in adults who are already taking both clopidogrel and acetylsalicylic acid as separate tablets.
Croatian: Clopidogrel/Acetylsalicylic acid Mylan lijek je za sprečavanje problema uzrokovanih krvnim ugrušcima i otvrdnućem arterija poput srčanog udara u odraslih koji već uzimaju i klopidogrel i acetilsalicilnu kiselinu u zasebnim tabletama.
English: Acetylsalicylic acid blocks an enzyme called prostaglandin cyclo-oxygenase.
Croatian: Acetilsalicilna kiselina blokira enzim naziva prostaglandin ciklooksigenaza.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Clopidogrel/Acetylsalicylic acid Mylan has been shown to have comparable quality and to be bioequivalent to DuoPlavin.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, utvrđeno da lijek Clopidogrel/Acetylsalicylic acid Mylan posjeduje usporedivu razinu kakvoće i da je bioekvivalentan lijeku DuoPlavin.
English: This means that Clopidogrel/Acetylsalicylic acid Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called DuoPlavin.
Croatian: To znači da Clopidogrel/Acetylsalicylic acid Mylan sadrži istu djelatnu tvar i djeluje na jednak način kao i „referentni lijek” koji je već odobren u EU-u pod nazivom DuoPlavin.
English: Because Clopidogrel/Acetylsalicylic acid Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je lijek Clopidogrel/Acetylsalicylic acid Mylan generički lijek te da je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.