FrancophonIA/ELRC3.0 huggingface dataset:
English: The special warnings and precautions relevant to both lamivudine and zidovudine are included in this section.
Croatian: U ovom su dijelu navedena posebna upozorenja i mjere opreza koja se odnose na lamivudin i zidovudin.
English: High doses of trimethoprim/ sulfamethoxazole for the treatment of Pneumocystis jirovecii pneumonia (PCP) and toxoplasmosis have not been studied and should be avoided.
Croatian: Pneumocystis jirovecii pneumonije (PCP) i toksoplazmoze nisu proučavane, te bi ih trebalo izbjegavati
English: The usual starting dose of Combivir is one half tablet (½) taken in the morning and one half tablet (½) taken in the evening.
Croatian: Uobičajena početna doza Combivira je pola (½) tablete ujutro i pola (½) tablete navečer.
English: Lamivudine and zidovudine are nucleoside analogues which have activity against HIV.
Croatian: Lamivudin i zidovudin su analozi nukleozida s aktivnošću protiv virusa humane imunodeficijencije
English: Read the information ‘Other possible side effects of combination therapy for HIV' in
Croatian: Pozorno pročitajte informacije “Ostale moguće nuspojave u kombiniranoj terapiji za
English: Skin and subcutaneous tissue disorders Uncommon : Rash and pruritus Rare : Nail and skin pigmentation, urticaria and sweating
Croatian: Manje često: osip i svrbež Rijetko: pigmentacija kože i noktiju, urtikarija i znojenje
English: Methadone dosage adjustment unlikely in majority of patients; occasionally methadone re-titration may be required.
Croatian: Potreba za prilagodbom doze za metadon je malo vjerojatna kod većine bolesnika;
English: Following single dose Combivir administration in healthy volunteers, mean (CV) lamivudine and zidovudine Cmax values were 1.6 µg/ml (32%) and 2.0 µg/ml (40%), respectively and the corresponding values for AUC were 6.1 µg h/ml (20%) and 2.4 µg h/ml (29%) respectively.
Croatian: Nakon primjene jedne doze Combivira zdravim dobrovoljcima, srednje (CV) vrijednosti Cmax lamivudina iznosile su 1,6 μg/ml (32%), a zidovudina 2,0 μg/ml (40%), a odgovarajuće vrijednosti AUC
English: URICOSURIC Probenecid/Lamivudine
Croatian: URIKOZURICI probenecid/lamivudin
English: • chest pain; disease of the heart muscle (cardiomyopathy)
Croatian: • bol u prsištu, bolest srčanog mišića (kardiomiopatija) • napadaji (konvulzije)
English: • stavudine, to treat HIV infection
Croatian: • stavudin, za liječenje infekcije HIV-om
English: 2 years
Croatian: 6.3 Rok valjanosti 2 godine
English: Uncommon : Myopathy
Croatian: Manje često: miopatija
English: Children weighing from 14 kg to 21 kg: the recommended oral dose of Combivir is one-half tablet taken twice daily.
Croatian: Djeca s tjelesnom težinom od 14 kg do 21 kg: preporučena oralna doza Combivira je pola tablete dva puta dnevno.
English: As well as the side effects listed below for Combivir, other conditions can develop during combination therapy for HIV.
Croatian: Osim nuspojava navedenih dolje za Combivir, za vrijeme kombinirane terapije za HIV, mogu se razviti i druge nuspojave.
English: • a decrease in the number of cells involved in blood clotting (thrombocytopenia) or in all kinds of blood cells (pancytopenia).
Croatian: • smanjenje broja stanica važnih za zgrušavanje krvi (trombocitopenija) ili svih vrsta krvnih stanica
English: A bioequivalence study compared Combivir with lamivudine 150 mg and zidovudine 300 mg tablets taken together.
Croatian: U studiji bioekvivalencije uspoređivao se Combivir s lamivudinom 150 mg i zidovudinom 300 mg u obliku tableta, uzimanih zajedno.
English: In any case, initiation of susceptible NRTI's should always be preferred to maintenance of lamivudine therapy.
Croatian: U svakom slučaju, preferira se započinjanje liječenja osjetljivim nukleozidnim inhibitorima reverzne transkriptaze u odnosu na nastavak terapije lamivudinom.
English: Metabolism and nutrition disorders Rare : Lactic acidosis in the absence of hypoxaemia, anorexia
Croatian: Rijetko: laktacidoza u odsutnosti hipoksemije, anoreksija
English: The 5'-glucuronide of zidovudine is the major metabolite in both plasma and urine, accounting for approximately 50-80% of the administered dose eliminated by renal excretion.
Croatian: Glavni metabolit zidovudina u plazmi i urinu je 5'-glukuronid i u tom se obliku bubrezima izlučuje 5080% primijenjene doze lijeka.
English: Resistance to thymidine analogues (of which zidovudine is one) is well characterised and is conferred by the stepwise accumulation of up to six specific mutations in the HIV reverse transcriptase at codons 41, 67, 70, 210, 215 and 219.
Croatian: Rezistencija na analoge timidina (zidovudin je jedan od njih) je dobro karakterizirana stupnjevitom akumulacijom do 6 specifičnih mutacija na HIV reverznoj transkriptazi, na kodonima 41,
English: Treatment with zidovudine has been associated with loss of subcutaneous fat which is most evident in the face, limbs and buttocks.
Croatian: Liječenje zidovudinom bilo je povezano s gubitkom potkožnog masnog tkiva koji je najočitiji na licu,
English: Combination therapy for HIV can also cause: • increased levels of lactic acid in the blood, which on rare occasions can lead to lactic acidosis
Croatian: • povišene razine mliječne kiseline u krvi koje u rijetkim slučajevima mogu dovesti do laktacidoze
English: • a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
Croatian: • zatajenje stvaranja novih crvenih krvnih stanica iz koštane srži (aplazija crvenih krvnih stanica).
English: Musculoskeletal and connective tissue disorders Common : Myalgia
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Često: mijalgija
English: They are white to off-white, capsuleshaped scored tablets marked with the code GXFC3 on both sides.
Croatian: Bijele su do gotove bijele filmom obložene tablete oblika kapsule s razdjelnim urezom i utisnutim natpisom “GXFC3” na obje strane.
English: Based on these data Combivir may be administered with or without food.
Croatian: Na osnovu ovih podataka, ustanovljeno je da se Combivir može uzimati sa i bez hrane.
English: Laboratorios ViiV Healthcare, S.L.
Croatian: VIIVHIV HEALTHCARE, UNIPESSOAL, LDA.
English: Combivir was shown to be bioequivalent to lamivudine 150 mg and zidovudine 300 mg given as separate tablets, when administered to fasting subjects.
Croatian: Pokazano je da je Combivir bioekvivalentan lamivudinu od 150 mg i zidovudinu od 300 mg ako se daju bolesnicima natašte kao odvojene tablete.
English: • probenecid, to treat gout and similar conditions, and given with some antibiotics to make them more effective
Croatian: • amfotericin ili kotrimoksazol, za liječenje gljivičnih i bakterijskih infekcija • probenecid, za liječenje gihta i sličnih stanja, uz terapiju antibioticima radi bolje efikasnosti
English: The clinically relevant effects of lamivudine and zidovudine in combination are anaemia, neutropenia and leucopenia.
Croatian: 5.3 Neklinički podaci o sigurnosti primjene Klinički značajni učinci kombinacije lamivudina i zidovudina su anemija, neutropenija i leukopenija.
English: As dosage adjustment of Combivir is not possible, separate preparations of zidovudine and lamivudine should be used.
Croatian: Kako prilagodba doze Combivira nije moguća, potrebno je primijeniti odvojene pripravke zidovudina i lamivudina.
English: Therapy should be initiated by a physician experienced in the management of HIV infection.
Croatian: 4.2 Doziranje i način primjene Liječenje treba započeti liječnik s iskustvom u liječenju HIV infekcije.
English: Very common : Nausea
Croatian: Vrlo često: mučnina
English: Hypromellose (E464), titanium dioxide (E171), macrogol 400, polysorbate 80
Croatian: natrijev škroboglikolat silicijev dioksid, koloidni magnezijev stearat Film ovojnica tablete: hipromeloza (E464) titanijev dioksid (E171) makrogol 400 polisorbat 80
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/058/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/058/001
English: Blood and lymphatic system disorders Common : Anaemia, neutropenia and leucopenia Uncommon: Thrombocyopenia and pancytopenia (with marrow hypoplasia) Rare : Pure red cell aplasia
Croatian: Često: anemija, neutropenija i leukopenija Manje često: trombocitopenija i pancitopenija (s hipoplazijom koštane srži) Rijetko: aplazija crvenih krvnih stanica
English: NAME OF THE MEDICINAL PRODUCT Combivir 150 mg/300 mg film-coated tablets
Croatian: NAZIV LIJEKA Combivir 150 mg/300 mg filmom obložene tablete
English: ANTI-INFECTIVE PRODUCTS Atovaquone/Lamivudine
Croatian: ANTIINFEKTIVNI LIJEKOVI atovakon/lamivudin
English: ANTIHISTAMINES (HISTAMINE H1 RECEPTOR ANTAGONISTS) Ranitidine/Lamivudine
Croatian: zidovudin AUC ↑80% (UGT inhibicija) ANTIHISTAMINICI (ANTAGONISTI HISTAMIN H1 RECEPTORA) ranitidin/lamivudin
English: Consider more frequent monitoring of HIV-1 viral load when chronic coadministration cannot be avoided.
Croatian: HIV-1 u slučaju kada se dugotrajna istodobna primjena ne može izbjeći.
English: ANTIMYCOBACTERIALS Rifampicin/Lamivudine
Croatian: ANTIMIKOBAKTERICI rifampicin/lamivudin
English: Combivir contains lamivudine and zidovudine, therefore any interactions identified for these individually are relevant to Combivir.
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Combivir sadrži lamivudin i zidovudin, stoga bilo koja uočena interakcija za individualne komponente je relevantna i za Combivir.
English: Uncommon : Fever, generalised pain and asthenia Rare :Chills, chest pain and influenza-like syndrome
Croatian: Rijetko: zimica, bolovi u prsnom košu i sindrom nalik na gripu
English: As Combivir contains lamivudine and zidovudine, the type and severity of adverse reactions associated with each of the compounds may be expected.
Croatian: Budući da Combivir sadrži i lamivudin i zidovudin, mogu se očekivati nuspojave karakteristične za oba lijeka.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN (NI) ZA PUŠTANJE
English: In a second study, mice were administered zidovudine at doses up to 40 mg/kg for 24 months, with exposure beginning prenatally on gestation day 10.
Croatian: 40 mg/kg, počevši prenatalno od 10. dana gestacije.
English: Other possible side effects of combination therapy for HIV Combination therapy such as Combivir may cause other conditions to develop during HIV treatment.
Croatian: Kombinirana terapija kao što je Combivir može uzrokovati druga stanja koja se mogu razviti za vrijeme liječenja HIV-a.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/058/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/058/002
English: Early symptoms (symptomatic hyperlactatemia) include benign digestive symptoms (nausea, vomiting and abdominal pain) non-specific malaise, loss of appetite, weight loss, respiratory symptoms (rapid and/or deep breathing) or neurological symptoms (including motor weakness).
Croatian: gubitak na tjelesnoj težini, respiratorne simptome (ubrzano i/ili duboko disanje) ili neurološke simptome (uključujući motoričku slabost).
English: Combivir 150 mg/300 mg film-coated tablets lamivudine/zidovudine
Croatian: Combivir 150 mg/300 mg filmom obložene tablete lamivudin/zidovudin
English: How to store Combivir
Croatian: Moguće nuspojave Kako čuvati Combivir
English: A large amount of data on pregnant women taking lamivudine or zidovudine indicate no malformative toxicity (more than 3000 outcomes from first trimester exposure each, of which over 2000 outcomes involved exposure to both lamivudine and zidovudine).
Croatian: Velika količina podataka koja se odnosi na trudne žene koje su uzimale lamivudin ili zidovudin ukazuje da ne postoji malformacijska toksičnost (više od 3000
English: Treatment with Combivir should be stopped immediately if clinical signs, symptoms or laboratory abnormalities suggestive of pancreatitis occur.
Croatian: Ukoliko se jave klinički znakovi, simptomi ili abnormalni laboratorijski nalazi koji ukazuju na pankreatitis, treba smjesta prekinuti liječenje Combivirom.
English: • fluconazole or flucytosine, to treat fungal infections such as candida
Croatian: • flukonazol ili flucitozin, za liječenje gljivičnih infekcija kao što je kandida • pentamidin ili atovakvanon, za liječenje infekcija parazitima kao što je pneumonija izazvana s
English: Skin and subcutaneous tissue disorders Common: Rash, alopecia Rare: Angioedema
Croatian: Često: osip, alopecija Rijetko: angioedem
English: NAME OF THE MEDICINAL PRODUCT Combivir 150 mg/300 mg tablets Lamivudine/zidovudine
Croatian: NAZIV LIJEKA Combivir 150 mg/300 mg tablete lamivudin/zidovudin
English: OPIOIDS Methadone/Lamivudine
Croatian: OPIOIDI metadon/lamivudin
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains lamivudine 150 mg zidovudine 300 mg
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži: 150 mg lamivudina 300 mg zidovudina
English: ANTIFUNGALS Fluconazole/Lamivudine
Croatian: ANTIMIKOTICI flukonazol/lamivudin
English: Opportunistic infections: Patients receiving Combivir or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection.
Croatian: Oportunističke infekcije: Bolesnici koji uzimaju Combivir ili bilo koju drugu antiretrovirusnu terapiju,
English: • high doses of co-trimoxazole, an antibiotic
Croatian: • visoke doze antibiotika kotrimoksazola • kladribin, koristi se za liječenje leukemije vlasastih stanica
English: Rare : Oral mucosa pigmentation, taste perversion and dyspepsia.
Croatian: Manje često: flatulencija Rijetko: pigmentacija oralne sluznice, promjene osjeta okusa i dispepsija, pankreatitis
English: During your treatment, your doctor will monitor you for signs of lactic acidosis.
Croatian: Vaš liječnik će nadzirati moguću pojavu znakova laktacidoze kod Vas.
English: General disorders and administration site conditions Common: Fatigue, malaise, fever
Croatian: Opći poremećaji i reakcije na mjestu primjene Često: umor, slabost, vrućica
English: • pyrimethamine, to treat malaria and other parasitic infections
Croatian: • pirimetamin, za liječenje malarije i ostalih infekcija parazitima • dapson, za prevenciju pneumonije i liječenje kožnih infekcija
English: Common : Raised blood levels of liver enzymes and bilirubin Rare : Liver disorders such as severe hepatomegaly with steatosis
Croatian: Rijetko: poremećaji jetre poput teške hepatomegalije sa steatozom Poremećaji kože i potkožnog tkiva
English: Late-onset neurological disorders have been reported rarely (hypertonia, convulsion, abnormal behaviour).
Croatian: (hipertonija, konvulzija, abnormalno ponašanje).
English: Interactions involving binding site displacement are not anticipated with Combivir.
Croatian: Za Combivir se ne očekuju interakcije lijekova koje uključuju promjene mjesta vezanja.
English: Fluconazole/Zidovudine (400 mg once daily/200 mg thrice daily)
Croatian: flukonazol/zidovudin (400 mg jedanput dnevno /200 mg triput dnevno)
English: ANTIRETROVIRAL MEDICINAL PRODUCTS Didanosine/Lamivudine
Croatian: LIJEKOVI didanozin/lamivudin
English: However, as dosage adjustments for zidovudine may be necessary, it is recommended that separate preparations of lamivudine and zidovudine be administered to patients with severe hepatic impairment.
Croatian: preporučuje se davanje odvojenih pripravaka lamivudina i zidovudina bolesnicima s teškim oštećenjem jetre.
English: Valproic acid/Zidovudine (250 mg or 500 mg thrice daily/100 mg thrice daily)
Croatian: Na-valproat (valproična kiselina)/zidovudin (250 mg ili 500 mg tri puta dnevno/100 mg tri puta dnevno)
English: When concomitant administration with cotrimoxazole is warranted, patients should be monitored
Croatian: Kada je neizbježna istodobna primjena s kotrimoksazolom,
English: ANTICONVULSANTS Phenobarbital/Lamivudine
Croatian: ANTIEPILEPTICI fenobarbital/lamivudin
English: Common : Dizziness
Croatian: Često: omaglica
English: Metabolism and nutrition disorders Very Rare: Lactic acidosis
Croatian: Poremećaji bubrega i mokraćnog sustava Rijetko: učestalo mokrenje
English: Uncommon side effects These may affect up to 1 in 100 people:
Croatian: Mogu se pojaviti u manje od 1 na 100 osoba:
English: Hepatobiliary disorders
Croatian: ANTIRETROVIRUSNI
English: Common : Vomiting, abdominal pain and diarrhoea Uncommon : Flatulence
Croatian: Često: povraćanje, bol u abdomenu i proljev
English: DATE OF REVISION OF THE TEXT MM/YYYY
Croatian: DATUM REVIZIJE TEKSTA
English: Cartons containing opaque polyvinyl chloride/foil blister packs.
Croatian: 6.5 Vrsta i sadržaj spremnika Kartonska kutija sadrži neprozirna polivnilklorid/aluminijska blister pakiranja.
English: Clarithromycin/Zidovudine (500 mg twice daily/100 mg every 4 hours)
Croatian: Odvojena primjena Combivira i klaritromicina kroz najmanje dva sata klaritromicin/zidovudin (500 mg dva puta dnevno/100 mg svakih 4 sata )
English: Microcrystalline cellulose (E460), sodium starch glycollate, colloidal silicon dioxide, magnesium stearate
Croatian: celuloza, mikrokristalična (E460)
English: Common side effects These may affect up to 1 in 10 people:
Croatian: Mogu se pojaviti u manje od 1 na 10 osoba:
English: Common: Nausea, vomiting, abdominal pain or cramps, diarrhoea Rare: Pancreatitis, rises in serum amylase
Croatian: Poremećaji probavnog sustava: Često: mučnina, povraćanje, abdominalna bol ili grčevi, proljev
English: Reproductive system and breast disorders Rare : Gynaecomastia
Croatian: Rijetko: ginekomastija
English: Section 4 of this leaflet.
Croatian: HIV” u dijelu 4 ove upute.
English: Cardiac disorders Rare :Cardiomyopathy
Croatian: Rijetko: kardiomiopatija
English: Respiratory, thoracic and mediastinal disorders Common: Cough, nasal symptoms
Croatian: Često: kašalj, simptomi rinitisa
English: Valproic acid/Lamivudine
Croatian: Na-valproat (valproična kiselina)/lamivudin
English: An uncommon side effect that may show up in blood test is:
Croatian: Vrlo rijetke nuspojave koje se mogu pojaviti u krvnim pretragama su:
English: Very rare side effects These may affect up to 1 in 10,000 people:
Croatian: Mogu se pojaviti u manje od 1 od 10 000 osoba:
English: clinically.
Croatian: LIJEKA
English: (often referred to as PCP)
Croatian: Pneumocystis jirovecii (koja se često naziva PCP)
English: − If you get any of the side effects talk to your doctor or pharmacist.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: • numbness
Croatian: • omamljenost
English: MA (EU) number (Invented) name
Croatian: Broj EU odobrenja (Novoizumljeno) ime
English: Oral use bottle (HDPE)
Croatian: Filmom obložena tableta Peroralna primjena Boca (HDPE)
English: The standard dose is one tablet once a day.
Croatian: Standardna doza je jedna tableta jedanput dnevno.
English: Dopamine is important for controlling movement and coordination.
Croatian: Dopamin je važan za kontrolu kretanja i koordinacije.
English: The full EPAR for Rasagiline Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Rasagiline Mylan nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This means that Rasagiline Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Azilect.
Croatian: To znači da je Rasagiline Mylan sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Azilect.
English: The Committee recommended that Rasagiline Mylan be approved for use in the EU.
Croatian: Odbor je preporučio odobrenje lijeka Rasagiline Mylan za korištenje u EU-u.
English: This is a summary of the European public assessment report (EPAR) for Rasagiline Mylan.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Rasagiline Mylan.
English: Rasagiline Mylan can be used either alone, or as an add-on to levodopa (another medicine used in Parkinson's disease) in patients who are having fluctuations in the control of their condition.
Croatian: Rasagiline Mylan može se koristiti kao monoterapija ili kao dodatak lijeku levodopa (drugom lijeku koji se koristi za liječenje Parkinsonove bolesti) u bolesnika kod kojih su prisutne fluktuacije u kontroli njihova stanja.
English: By increasing levels of dopamine in the parts of the brain that control movement and coordination, Rasagiline Mylan reduces the symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Croatian: Povećanjem razina dopamina u dijelovima mozga koji kontroliraju kretanje i koordinaciju, lijek Rasagiline Mylan smanjuje simptome Parkinsonove bolesti kao što su ukočenost i usporeno kretanje.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Rasagiline Mylan has been shown to have comparable quality and to be bioequivalent to Azilect.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, potvrđeno kako Rasagiline Mylan posjeduje usporedivu razinu kvalitete te je bioekvivalentan s lijekom Azilect.
English: Rasagiline Mylan is available as tablets (1 mg).
Croatian: Rasagiline Mylan dostupan je u obliku tableta (od 1 mg).
English: It blocks the enzyme monoamine oxidase type B, which breaks down a substance called dopamine in the brain.
Croatian: Djeluje blokiranjem enzima monoamin oksidaze-B koji u mozgu razgrađuje tvar naziva dopamin.
English: Rasagiline Mylan is a medicine used to treat adults with Parkinson's disease (a progressive brain disorder that causes shaking, slow movement and muscle stiffness).
Croatian: Rasagiline Mylan lijek je koji se koristi za liječenje odraslih osoba s Parkinsonovom bolešću (progresivnim moždanim poremećajem koji uzrokuje drhtanje, usporene pokrete i krutost mišića).
English: The active substance in Rasagiline Mylan, rasagiline, is a ‘monoamine oxidase B inhibitor'.
Croatian: Djelatna tvar u lijeku Rasagiline Mylan, razagilin, je "inhibitor monoamin oksidaze-B".
English: What is Rasagiline Mylan and what is it used for?
Croatian: Što je Rasagiline Mylan i za što se koristi?
English: It is not intended to provide practical advice on how to use Rasagiline Mylan.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Rasagiline Mylan.
English: What measures are being taken to ensure the safe and effective use of Rasagiline Mylan?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Rasagiline Mylan?
English: A risk management plan has been developed to ensure that Rasagiline Mylan is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Rasagiline Mylan.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rasagiline Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku za lijek Rasagiline Mylan uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: What are the benefits and risks of Rasagiline Mylan?
Croatian: Koje su koristi i rizici od lijeka Rasagiline Mylan?
English: Because Rasagiline 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 Rasagiline Mylan generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i kod referentnog lijeka.
English: Rasagiline Mylan is a ‘generic medicine'.
Croatian: Rasagiline Mylan je „generički lijek”.
English: For more information about treatment with Rasagiline Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Rasagiline Mylan pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Rasagiline Mylan rasagiline
Croatian: Rasagiline Mylan razagilin