FrancophonIA/ELRC3.0 huggingface dataset:
English: pancytopenia (probably by antiproliferative mechanism), leucopenia (leucocytes < 2 G/l), eosinophilia
Croatian: pancitopenija (vjerojatno povezana s antiproliferativnim mehanizmom djelovanja), leukopenija (leukociti <2 g/l), eozinofilija
English: ALT (SGPT) must be checked before initiation of leflunomide and at the same frequency as the complete blood cell count (every two weeks) during the first six months of treatment and every 8 weeks thereafter.
Croatian: ALT (SGPT) se mora provjeriti prije početka liječenja leflunomidom te u jednakim razmacima kao i kompletnu krvnu sliku, odnosno svaka dva tjedna, tijekom prvih 6 mjeseci liječenja i nakon toga svakih 8 tjedana.
English: If both plasma concentrations are below 0.02 mg/l, and after a waiting period of at least 3 months, the risk of foetal toxicity is very low.
Croatian: Ako je u oba slučaja koncentracija u plazmi manja od 0,02 mg/l, a nakon stanke od najmanje 3 mjeseca, rizik od fetalne toksičnosti vrlo je malen.
English: Moreover, switching from leflunomide to another DMARD without following the washout procedure (see section 4.4) may also increase the risk of serious adverse reactions even for a long time after the switching.
Croatian: Osim toga, prijelaz s leflunomida na neki drugi DMARD, bez provedbe ispiranja („washout“ postupak) leflunomida (vidjeti dio 4.4.), također može povećati rizik od ozbiljnih nuspojava, čak i dulje vrijeme nakon promjene lijeka.
English: Leflunomide was embryotoxic and teratogenic in rats and rabbits at doses in the human therapeutic range and exerted adverse effects on male reproductive organs in repeated dose toxicity studies.
Croatian: Leflunomid je bio embriotoksičan i teratogen u štakora i kunića u terapijskim dozama za ljude te je izazvao nuspojave na reproduktivnim organima mužjaka pri istraživanjima toksičnosti ponovljenih doza.
English: Therefore, when such toxicities occur or if for any other reason A771726 needs to be cleared rapidly from the body, the washout procedure has to be followed.
Croatian: Stoga, pri pojavi tih toksičnosti ili potrebe za brzim uklanjanjem A771726 iz organizma zbog bilo kojeg drugog razloga treba obaviti ispiranje ("washout" postupak) Ako je klinički neophodno, postupak se može ponoviti.
English: However, also following either of the washout procedures, verification by 2 separate tests at an interval of at least 14 days and a waiting period of one-and-a-half months between the first occurrence of a plasma concentration below 0.02 mg/l and fertilisation is required.
Croatian: Međutim, nakon primjene bilo kojeg navedenog ispiranja („washout“ postupak) potrebno je provjeriti koncentraciju u plazmi na osnovi dva testa provedena u razmaku od najmanje 14 dana i uz razdoblje čekanja od najmanje mjesec i pol između prvog nalaza koncentracije u plazmi niže od 0,02 mg/l i začeća.
English: Repso is contraindicated in patients with severe hypoproteinaemia or impairment of liver function (see section 4.3).
Croatian: Repso je kontraindiciran u bolesnika s teškom hipoproteinemijom ili oštećenom jetrenom funkcijom (vidjeti dio 4.3.).
English: The ACR (American College of Rheumatology) response rates in study YU203 were 27.7 % for placebo, 31.9 % for 5 mg, 50.5 % for 10 mg and 54.5 % for 25 mg/day.
Croatian: Stope terapijskog odgovora prema ACR-u (American College of Rheumatology) u studiji YU203 bile su 27,7% za placebo, 31,9% za 5 mg/dan, 50,5% za 10 mg/dan i 54,5% za 25 mg/dan.
English: Repso tablets are tablets for oral use.
Croatian: Repso tablete su tablete za peroralnu primjenu.
English: Titanium dioxide (E171) Polydextrose (E1200) Hypromellose (E464) Triethyl citrate (E1505) Macrogol 8000
Croatian: Ovojnica tablete titanijev dioksid (E171) polidekstroza (E1200) hipromeloza (E464) trietilcitrat (E1505) makrogol 8000
English: You will then need a blood test to make sure that Repso has been sufficiently removed from your body, and you should then wait for at least another 3 months before attempting to father a child.
Croatian: Trebat ćete napraviti krvne pretrage kako biste bili sigurni da je Repso u dovoljnoj mjeri uklonjen iz tijela i nakon toga pričekati najmanje sljedeća tri mjeseca prije pokušaja ostvarivanja očinstva.
English: The pharmacokinetics of A771726 following oral administration of leflunomide have been investigated in 73 pediatric patients with polyarticular course Juvenile Rheumatoid Arthritis (JRA) who ranged in age from 3 to 17 years.
Croatian: Farmakokinetika A771726 nakon oralne primjene leflunomida ispitivana je u 73 pedijatrijska bolesnika u dobi od 3 do 17 godina s poliartikuliranim oblikom juvenilnog reumatoidnog artritisa (JRA).
English: elevation of liver parameters (transaminases [especially ALT], less often gamma-GT, alkaline phosphatase, bilirubin)
Croatian: povišene vrijednosti jetrenih enzima (transaminaze (posebno ALT), rjeđe gama-GT, alkalne fosfataze, bilirubina)
English: Colestyramine given orally at a dose of 8 g three times a day for 24 hours to three healthy volunteers decreased plasma levels of A771726 by approximately 40 % in 24 hours and by 49 % to 65 % in 48 hours.
Croatian: Kolestiramin u dozi od 8 g primijenjen oralno tri puta tijekom 24 sata u tri zdrava dobrovoljca smanjio je koncentraciju A771726 u plazmi za oko 40% u 24 sata, te za 49% do 65% u 48 sati.
English: Women of childbearing potential must not take Repso without using reliable contraceptive measures, and they must use reliable contraceptive measures up to 2 years after treatment.
Croatian: Repso ako ne koriste učinkovitu kontracepciju i moraju primjenjivati pouzdane mjere kontracepcije do 2 godine nakon liječenja.
English: Due to the very long half-lifeof A771726 (approximately 2 weeks), a loading dose of 100 mg for 3 days was used in clinical studies to facilitate the rapid attainment of steady-state levels of A771726.
Croatian: Zbog veoma dugog poluvijeka A771726 (oko 2 tjedna) u kliničkim je ispitivanjima primjenjivana udarna doza od 100 mg tijekom 3 dana kako bi se ubrzalo postizanje stanja dinamičke ravnoteže A771726.
English: Leflunomide 20 mg/day was significantly superior to placebo in reducing the symptoms of arthritis in patients with psoriatic arthritis: the PsARC (Psoriatic Arthritis treatment Response Criteria) responders were 59 % in the leflunomide group and 29.7 % in the placebo group by 6 months (p < 0.0001).
Croatian: Leflunomid, 20 mg dnevno, pokazao se značajno boljim u smanjenju simptoma artritisa u odnosu na placebo u bolesnika sa psorijatičnim artritisom: od bolesnika koji su odgovorili na liječenje prema kriterijima PsARC (Psoriatic Arthritis Treatment Response Criteria) 59% bilo je u skupini liječenoj leflunomidom, a 29,7% u skupini koja je primala placebo u trajanju od 6 mjeseci (p<0,0001).
English: • alternatively, 50 g of activated powdered charcoal is administered 4 times daily for a period of 11 days.
Croatian: • alternativno, 50 g aktivnog ugljena u prahu četiri puta na dan tijekom 11 dana.
English: • Tablet coating: titanium dioxide, hypromellose, macrogol 400, iron oxide yellow, polysorbate, quinoline yellow aluminium lake and indigo carmine aluminium lake.
Croatian: • Ovojnica tablete: titanijev dioksid, hipromeloza, makrogol 400, željezov oksid žuti, polisorbat, quinoline yellow aluminium lake i indigo carmine aluminium lake.
English: • Patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia due to causes other than rheumatoid or psoriatic arthritis.
Croatian: • Bolesnici sa značajno oštećenom funkcijom koštane srži ili izraženom anemijom, leukopenijom, neutropenijom ili trombocitopenijom, koje nisu uzrokovane reumatoidnim ili psorijatičnim artritisom.
English: After this the dose is: - For rheumatoid arthritis: 10 mg or 20 mg once daily depending on the severity of the disease.
Croatian: Nakon toga doza iznosi: - Za reumatoidni artritis: 10 mg ili 20 mg jedanput na dan ovisno o težini bolesti.
English: Repso is used to treat adult patients with active rheumatoid arthritis or with active psoriatic arthritis.
Croatian: Repso se primjenjuje za liječenje odraslih bolesnika s aktivnim oblikom reumatoidnog artritisa ili s aktivnim oblikom psorijatičnog artritisa.
English: Effect of other medicinal products on leflunomide
Croatian: Utjecaj drugih lijekova na leflunomid
English: Administration of activated charcoal (powder made into a suspension) orally or via nasogastric tube (50 g every 6 hours for 24 hours) has been shown to reduce plasma concentrations of the active metabolite A771726 by 37 % in 24 hours and by 48 % in 48 hours.
Croatian: Primjenom aktivnog ugljena (prašak pripravljen kao suspenzija) oralno ili putem nazogastrične sonde (50 g svakih 6 sati tijekom 24 sata) smanjila se koncentracija aktivnog metabolita A771726 za 37% u roku od 24 sata i za 48% u roku od 48 sati.
English: red skin stains, or blisters e.g. Stevens-Johnson syndrome) or any of the other ingredients of this medicine (listed in section 6), or if you are allergic to teriflunomide (used to treat multiple sclerosis).
Croatian: Johnsonov sindrom) ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) ili ako ste alergični na teriflunomid (primjenjuje se za liječenje multiple skleroze).
English: OUTER CARTON/BLISTER PACK
Croatian: VANJSKA KUTIJA/BLISTER PAKIRANJE
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Repso
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego što uzmete Repso.
English: - If you already have low red or white blood cells (anaemia or leucopenia), low blood platelets, which may increase your bleeding or bruising (thrombocytopenia), low bone marrow function or if you are at risk of your bone marrow not working properly your doctor may advise you to take certain medicines to speed up the removal of Repso from your body.
Croatian: - Ako već imate niske razine crvenih ili bijelih krvnih stanica (anemiju ili leukopeniju), niske razine trombocita, što može povećati rizik od krvarenja ili pojave modrica (trombocitopenija), odnosno ako imate smanjenu funkciju koštane srži ili ako postoji rizik od oštećenja funkcije koštane srži, liječnik Vam može savjetovati uzimanje određenih lijekova koji će ubrzati uklanjanje Repsa iz tijela.
English: Each film-coated tablet contains 97.25 mg of lactose monohydrate and 3.125 mg anhydrous lactose.
Croatian: Jedna filmom obložena tableta sadrži 97,25 mg laktoze hidrata i 3,125 mg bezvodne laktoze.
English: A more rapid elimination of A771726 was observed in haemodialysis subjects which was not due to extraction of drug in the dialysate.
Croatian: Znatno brža eliminacija A771726 zapažena je u hemodijaliziranih bolesnika, što nije bilo povezano s ekstrakcijom lijeka u dijalizat.
English: - If you develop swollen spongy gums, ulcers, and loose teeth (an infectious mouth disease known as ulcerative stomatitis) then you should contact your doctor who may advise you to stop taking Repso.
Croatian: - Ako Vam otiču desni, imate čireve u usnoj šupljini ili gubite zube (odnosno imate infekciju usne šupljine koja se zove ulcerozni stomatitis), morate se javiti svom liječniku koji će Vam možda savjetovati da prestanete uzimati Repso.
English: Adverse events consistent with the safety profile for leflunomide were: abdominal pain, nausea, diarrhoea, elevated liver enzymes, anaemia, leucopenia, pruritus and rash.
Croatian: Nuspojave u skladu sa sigurnosnim profilom leflunomida bile su: bol u trbuhu, mučnina, proljev, povišene vrijednosti jetrenih enzima, anemija, leukopenija, svrbež i osip.
English: Do not take Repso when you are breast-feeding, as leflunomide passes into the breast milk.
Croatian: Nemojte uzimati Repso dok dojite jer se leflunomid izlučuje u majčino mlijeko.
English: How to take Repso
Croatian: Kako uzimati Repso
English: Effect of leflunomide on other medicinal products
Croatian: Utjecaj leflunomida na druge lijekove
English: - If you have bone marrow problems, or if you have low numbers of red or white blood cells or a reduced number of blood platelets, due to causes other than rheumatoid or psoriatic arthritis.
Croatian: - Ako imate problema s koštanom srži ili ako imate smanjen broj crvenih ili bijelih krvnih stanica ili krvnih pločica (trombocita) koji nije uzrokovan reumatoidnim ili psorijatičnim artritisom.
English: As soon as skin and/or mucosal reactions are observed which raise the suspicion of such severe reactions, Repso and any other possibly associated treatment must be discontinued, and a leflunomide washout procedure initiated immediately.
Croatian: Čim se pojave reakcije na koži i/ili sluznici koje izazivaju sumnju na teške nuspojave, uzimanje Repsa ili bilo kojeg dodatnog lijeka treba prekinuti i odmah započeti postupak eliminacije leflunomida.
English: Interstitial lung disease, as well as rare cases of pulmonary hypertension have been reported during treatment with leflunomide (see section 4.8).
Croatian: Za vrijeme liječenja leflunomidom zabilježena je intersticijska plućna bolest, kao i rijetki slučajevi plućne hipertenzije (vidjeti dio 4.8.).
English: The doctor that starts you on Repso and supervises you while you are on it should be experienced in the treatment of rheumatoid arthritis and psoriatic arthritis.
Croatian: Liječnik koji Vam uvede terapiju Repsom i koji Vas nadzire tijekom terapije treba imati iskustva u liječenju reumatoidnog i psorijatičnog artritisa.
English: Swallow tablets whole.
Croatian: Tablete progutati cijele.
English: Each film-coated tablet contains 194.5 mg of lactose monohydrate and 6.25 mg anhydrous lactose.
Croatian: Jedna tableta sadrži 194,5 mg laktoze hidrata i 6,25 mg bezvodne laktoze.
English: - If you switch to another medicine to treat your rheumatoid arthritis or if you have recently taken medicines that may be harmful to your liver or blood, your doctor may advise you to take certain medicines to speed up the removal of Repso from your body or may closely monitor you when you start taking Repso.
Croatian: - Ako počnete uzimati neki drugi lijek za liječenje reumatoidnog artritisa ili ste nedavno uzimali lijekove koji mogu biti štetni za jetru ili krv, liječnik Vam može savjetovati uzimanje određenih lijekova koji će ubrzati uklanjanje
English: Studies with both hemodialysis and CAPD (chronic ambulatory peritoneal dialysis) indicate that A771726, the primary metabolite of leflunomide, is not dialysable.
Croatian: Studije s hemodijalizom i kroničnom ambulantnom peritonealnom dijalizom upućuju da se A771726, primarni metabolit leflunomida, ne može dijalizirati.
English: The symptoms include inflammation of joints, swelling, difficulty moving, pain and patches of red, scaly skin (skin lesions).
Croatian: Simptomi psorijatičnog artritisa uključuju upalu i oticanje zglobova, poteškoće u kretanju, bol i područja crvene, ljuskaste kože (kožne lezije).
English: If a waiting period of up to approximately 2 years under reliable contraception is considered unpractical, prophylactic institution of a washout procedure may be advisable.
Croatian: Ako nije moguće čekati dvije godine uz odgovarajuću kontracepciju, preporučuje se profilaktički započeti ispiranje („washout“ postupak).
English: It may also cause some serious allergic reactions (including Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]), or increase the chance of a severe infection.
Croatian: Također, može uzrokovati neke ozbiljne alergijske reakcije (uključujući reakciju na lijek s eozinofilijom i sistemskim simptomima, engl.
English: In the phase III trials, the ACR response rates for leflunomide 20 mg/day versus placebo were 54.6 % versus 28.6 % (study MN301), and 49.4 % versus 26.3 % (study US301).After 12 months with active treatment, the ACR response rates in leflunomide patients were 52.3 % (studies MN301/303), 50.5 % (study MN302) and 49.4 % (study US301), compared to 53.8 % (studies MN301/303) in sulphasalazine patients, 64.8 % (study MN302), and 43.9 % (study US301) in methotrexate patients.
Croatian: Nakon 12 mjeseci aktivnog liječenja stopa odgovora prema ACR-u u bolesnika koji su primali leflunomid bila je 52,3% (studije MN301/303), 50,5% (studija MN302) i 49,4% (studija US301) u usporedbi s 53,8% (studije MN301/303) u bolesnika koji su primali sulfasalazin te 64,8% (studija MN302) i 43,9% (studija US301) u bolesnika koji su primali metotreksat.
English: Since Repso can cause an increase in your blood pressure, your doctor will also check your blood pressure regularly.
Croatian: Liječnik će Vam također redovito kontrolirati krvni tlak jer Repso može uzrokovati njegovo povećanje.
English: Before and during treatment with Repso, your doctor will carry out blood tests at regular times.
Croatian: Prije i za vrijeme liječenja Repsom liječnik će Vas u redovitim razmacima slati na krvne pretrage zbog kontrole Vaših krvnih stanica i jetre.
English: increased hair loss, eczema, rash (including maculopapular rash), pruritus, dry skin
Croatian: pojačani gubitak kose, ekcem, osip (uključujući makulopapulozni osip), svrbež, suha koža
English: - If you develop a skin rash or ulcers in your mouth, as these may indicate severe, sometimes life-threatening reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]), see section 2.
Croatian: Ako dobijete kožni osip ili čireve u ustima jer to može upućivati na teške reakcije, ponekad opasne po život (npr. Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, multiformni eritem, reakcija na lijek s eozinofilijom i sistemskim simptomima, engl.
English: In case of severe haematological reactions, including pancytopenia, Repso and any concomitant myelosuppressive treatment must be discontinued and a leflunomide washout procedure initiated.
Croatian: U slučaju teških hematoloških reakcija, uključujući pancitopeniju, treba prekinuti liječenje Repsom i bilo kojim istodobno primijenjenim mijelosupresivnim lijekom te početi postupak eliminacije leflunomida.
English: - If you suffer from moderate to severe kidney problems.
Croatian: - Ako imate umjerene do teške probleme s bubrezima.
English: severe liver injury such as hepatic failure and acute hepatic necrosis that may be fatal
Croatian: Vrlo rijetko: teško oštećenje jetre poput zatajenja jetre i akutne hepatičke nekroze koja može završiti smrtnim ishodom
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg of leflunomide LIST OF EXCIPIENTS Contains lactose (see leaflet for further information).
Croatian: TVARI Jedna tableta sadrži 10 mg leflunomida POPIS POMOĆNIH TVARI Sadrži laktozu (vidjeti Uputu o lijeku za dodatne informacije).
English: hypokalaemia, hyperlipidemia, hypophosphataemia
Croatian: Manje često: hipokalijemija, hiperlipidemija, hipofosfatemija Rijetko:
English: How to store Repso
Croatian: Kako čuvati Repso
English: Repso contains lactose.
Croatian: Repso sadrži laktozu.
English: severe anaphylactic/anaphylactoid reactions, vasculitis, including cutaneous
Croatian: Vrlo rijetko: teške anafilaktične/anafilaktoidne reakcije, vaskulitis, uključujući kožni nekrotizirajući vaskulitis
English: • Breast-feeding women (see section 4.6).
Croatian: • Dojilje (vidjeti dio 4.6.).
English: This medicinal product contains lactose (see leaflet for further information).
Croatian: Ovaj lijek sadrži laktozu (Vidjeti Uputu o lijeku za dodatne informacije).
English: 28 film-coated tablets 30 film-coated tablets 100 film-coated tablets
Croatian: 28 filmom obloženih tableta 30 filmom obloženih tableta 100 filmom obloženih tableta
English: There was an increase in mean ethinylestradiol Cmax and AUC0-24 (1.58- and 1.54-fold, respectively) and levonorgestrel Cmax and AUC0-24 (1.33- and 1.41-fold, respectively) following repeated doses of A771726.
Croatian: Zabilježeno je povećanje prosječne Cmax i AUC0-24 (1,58 odnosno 1,54 puta) za etinilestradiol i povećanje prosječne Cmax i AUC0-24 (1,33 odnosno 1,41 puta) za levonorgestrel, nakon ponovljenih doza A771726.
English: Repso provided in blisters are available in pack sizes of 28, 30 and 100 film-coated tablets.
Croatian: Repso u blisterima je dostupan u veličinama pakiranja od 28, 30 i 100 filmom obloženih tableta.
English: The most frequently reported adverse effects with leflunomide are: mild increase in blood pressure, leucopenia, paraesthesia, headache, dizziness, diarrhoea, nausea, vomiting, oral mucosal disorders (e.g. aphthous stomatitis, mouth ulceration), abdominal pain, increased hair loss, eczema, rash (including maculo-papular rash), pruritus, dry skin, tenosynovitis, CPK increased, anorexia, weight loss (usually insignificant), asthenia, mild allergic reactions and elevation of liver parameters (transaminases (especially ALT), less often gamma-GT, alkaline phosphatise, bilirubin.
Croatian: Najčešće zabilježene nuspojave tijekom primjene leflunomida su: blagi porast krvnog tlaka, leukopenija, parestezija, glavobolja, omaglica, proljev, mučnina, povraćanje, poremećaji sluznice usne šupljine (npr. aftozni stomatitis, ulceracije u ustima), bol u trbuhu, pojačani gubitak kose, ekcem, osip (uključujući makulopapulozni osip), svrbež, suha koža, tenosinovitis, povećanje CPK, anoreksija, gubitak težine (obično beznačajan), astenija, blage alergijske reakcije i porast jetrenih parametara (transaminaze (osobito ALT), manje često gama-GT, alkalna fosfataza, bilirubin).
English: In such cases re-exposure to leflunomide is contra-indicated (see section 4.3).
Croatian: U tim je slučajevima neophodna potpuna eliminacija lijeka, a ponovno uzimanje leflunomida je kontraindicirano (vidjeti dio 4.3.).
English: Repso provided in tablet containers are available in pack sizes of 30 and 100 film-coated tablets.
Croatian: Repso u spremnicima za tablete je dostupan u veličinama pakiranja od 30 i 100 filmom obloženih tableta.
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet 30 tablets 100 tablets METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Croatian: FARMACEUTSKI OBLIK I SADRŽAJ Filmom obložena tableta 30 tableta 100 tableta NAČIN I PUT(EVI) PRIMJENE LIJEKA Kroz usta.
English: Male patients should be aware of the possible male-mediated foetal toxicity.
Croatian: Muški bolesnici moraju biti svjesni da mogu biti posrednici u pojavi fetalne toksičnosti.
English: The efficacy of leflunomide was demonstrated in one controlled, randomised, double blind study 3L01 in 188 patients with psoriatic arthritis, treated at 20 mg/day.
Croatian: Djelotvornost leflunomida u liječenju psorijatičnog artritisa pokazala se u jednoj kontroliranoj, randomiziranoj, dvostruko slijepoj studiji 3L01 na 188 bolesnika sa psorijatičnim artritisom.
English: Pack sizes of 28, 30 and 100 film-coated tablets.
Croatian: Veličine pakiranja od 28, 30 i 100 filmom obloženih tableta.
English: • In psoriatic arthritis: leflunomide therapy is started with a loading dose of 100 mg once daily for 3 days.
Croatian: • U bolesnika sa psorijatičnim artritisom: liječenje leflunomidom započinje primjenom udarne doze od 100 mg jedanput na dan tijekom 3 dana.
English: For tablets stored in tablet containers: Do not store above 30°C.
Croatian: Tablete u spremnicima za tablete: Ne čuvati na temperaturi iznad 30°C.
English: Tell your doctor immediately and stop taking Repso - If you feel weak, light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic reaction.
Croatian: - Ako osjetite slabost, ošamućenost ili omaglicu ili imate poteškoće s disanjem jer to mogu biti znaci ozbiljne alergijske reakcije.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Teva B.V.
Croatian: IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Teva B.V.
English: Do not use this medicine after the expiry date that is stated on the outer carton,blister or tablet container after EXP.
Croatian: Ovaj lijek ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na vanjskom pakiranju, blisteru ili spremniku za tablete iza oznake „Rok valjanosti“ ili kratice „EXP“.
English: Do not use this medicine after the expiry date that is stated on the outer carton, blister or tablet container after EXP.
Croatian: Ovaj lijek ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na vanjskom pakiranju, blisteru ili spremniku za tablete iza oznake "Rok valjanosti" ili kratice „EXP“.