natgillin/translations-raw huggingface dataset:
Leflunomide Zentiva 10 mg film-coated tablets are white to almost white and round.
Kako Leflunomide Zentiva izgleda i sadržaj pakiranja Leflunomide Zentiva 10 mg filmom obložene tablete su bijele do gotovo bijele i okrugle.
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.
Nakon 12 mjeseci aktivnog liječenja stopa odgovora prema ACRu u bolesnika koji su primali leflunomid bila je 52,3% (ispitivanja MN301/303), 50,5% (ispitivanje MN302) i 49,4% (ispitivanje US301) u usporedbi s 53,8% (ispitivanja MN301/303) u bolesnika koji su primali sulfasalazin te 64,8% (ispitivanje MN302) i 43,9% (ispitivanje US301) u bolesnika koji su primali metotreksat.
30 film-coated tablets 50 film-coated tablets 100 film-coated tablets
OBLIK I SADRŽAJ 30 filmom obloženih tableta 50 filmom obloženih tableta 100 filmom obloženih tableta
Breast-feeding women must, therefore, not receive leflunomide.
Dojilje, stoga, ne smiju uzimati leflunomid.
Excipients with known effect Each tablet contains 72 mg of lactose monohydrate.
Pomoćne tvari s poznatim učinkom Jedna tableta sadrži 72 mg laktoze hidrata.
Pregnancy must be excluded before start of treatment with leflunomide.
Prije liječenja leflunomidom mora se isključiti trudnoća.
This is especially important if you are taking: - other medicines for rheumatoid arthritis such as antimalarials (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive medicines (e.g. methotrexate) as these combinations are not advisable, - warfarin and other oral medicines used to thin the blood, as monitoring is necessary to reduce the risk of side effects of this medicine - teriflunomide for multiple sclerosis - repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes - daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer - duloxetine for depression, urinary incontinence or in kidney disease in diabetics - alosetron for the management of severe diarrhoea - theophylline for asthma - tizanidine, a muscle relaxant - oral contraceptives (containing ethinylestradiol and levonorgestrel) - cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections - indomethacin, ketoprofen for pain or inflammation - furosemide for heart disease (diuretic, water pill)
azatioprina i drugih imunosupresivnih lijekova (npr. metotreksat), jer se ne preporučuje istodobna primjena tih lijekova, - varfarin i druge oralne lijekove koji se koriste za razrjeđivanje krvi, jer je potrebno praćenje kako bi se smanjio rizik od nuspojava tih lijekova - teriflunomid za liječenje multiple skleroze - repaglinid, pioglitazon, nateglinid ili roziglitazon za liječenje šećerne bolesti - daunorubicin, doksorubicin, paklitaksel ili topotekan za liječenje raka - duloksetin za liječenje depresije, nesposobnosti zadržavanja mokraće ili bolesti bubrega u oboljelih od šećerne bolesti - alosetron za liječenje teškog proljeva - teofilin za liječenje astme - tizanidin, lijek za opuštanje mišića - oralni lijekovi za sprječavanje trudnoće (koji sadrže etinilestradiol i levonorgestrel) - cefaklor, benzilpenicilin (penicilin G), ciprofloksacin, za liječenje infekcija
Musculoskeletal and connective tissue disorders Common:
Poremećaji mišićno-koštanog sustava i vezivnog tkiva Često:
Methotrexate
Cijepljenje
Yellowish to ochre and triangular film-coated tablet, imprinted with ZBO on one side.
Žućkasta do oker filmom obložena tableta u obliku trokuta, s utisnutom oznakom ZBO na jednoj strani.
• In rheumatoid arthritis: leflunomide therapy is usually started with a loading dose of 100 mg once daily for 3 days.
• U bolesnika s reumatoidnim artritisom: terapija leflunomidom započinje primjenom udarne doze od 100 mg jedanput na dan tijekom 3 dana.
- a decrease in the number of red blood cells (anaemia) and a decrease in the number of blood platelets (thrombocytopenia), - a decrease in the levels of potassium in the blood, - anxiety, - taste disturbances, - urticaria (nettle rash), - tendon rupture, - an increase in the levels of fat in the blood (cholesterol and triglycerides), - a decrease in the levels of phosphate in the blood.
Manje česte nuspojave (mogu se javiti u manje od 1 na 100 osoba): - smanjen broj crvenih krvnih stanica (anemija) i smanjen broj krvnih pločica (trombocitopenija), - smanjenje koncentracije kalija u krvi, - tjeskoba, - poremećaji okusa, - urtikarija (koprivnjača), - puknuće tetive, - povećanje razine masnoća u krvi (kolesterol i trigliceridi), - smanjenje razine fosfata u krvi.
• In psoriatic arthritis: leflunomide therapy is started with a loading dose of 100 mg once daily for 3 days.
• U bolesnika s psorijatičnim artritisom: liječenje leflunomidom započinje primjenom udarne doze od 100 mg jedanput na dan tijekom 3 dana.
The concentration may be expected to decrease below 0.02 mg/L about 2 years after stopping the treatment with leflunomide.
Smanjenje koncentracije A771726 u plazmi na razinu nižu od 0,02 mg/l očekuje se približno 2 godine nakon prekida liječenja leflunomidom.
agranulocytosis
hipouricemija
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
MN301/303) in sulphasalazine patients, 64.8% (study MN302), and 43.9% (study US301) in methotrexate patients.
MN302) i 49,4% (ispitivanje US301) u usporedbi s 53,8% (ispitivanja MN301/303) u bolesnika koji su primali sulfasalazin te 64,8% (ispitivanje MN302) i 43,9% (ispitivanje US301) u bolesnika koji su primali metotreksat.
colitis including microscopic colitis such as lymphocytic colitis, collagenous colitis, diarrhoea, nausea, vomiting, oral mucosal disorders (e.g., aphthous stomatitis, mouth ulceration), abdominal pain
kolitis, uključujući mikroskopski kolitis poput limfocitnog kolitisa, kolagenog kolitisa, proljev, mučnina, povraćanje, poremećaji sluznice usne šupljine (npr. aftozni stomatitis, ulceracije u ustima), bol u abdomenu Manje često: poremećaji okusa
Certain vaccinations should not be given while taking Leflunomide Zentiva, and for a certain amount of time after stopping treatment.
Za vrijeme uzimanja lijeka Leflunomide Zentiva, kao i određeno vrijeme nakon prekida liječenja, ne smije se provoditi cijepljenje određenim cjepivima.
All elevations resolved 2 with continuation of both medicinal products and 3 after discontinuation of leflunomide.
Sve su se povišene vrijednosti smanjile, u 2 bolesnika koji su nastavili istodobno uzimati oba lijeka i u 3 bolesnika koji su prekinuli uzimati leflunomid.
Pack size: 3 film-coated tablets.
Veličina pakiranja: 3 filmom obložene tablete
How to store Leflunomide Zentiva
Kako čuvati lijek Leflunomide Zentiva
In either case the A771726 plasma concentration is then measured for the first time.
U oba se slučaja tek tada prvi put mjeri koncentracija A771726 u plazmi.
The active metabolite A771726 is extensively protein bound and cleared via hepatic metabolism and biliary secretion.
Aktivni metabolit A771726 ekstenzivno se veže za proteine u plazmi, a uklanja se jetrenim metabolizmom te izlučuje putem žuči.
• Patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia due to causes other than rheumatoid or psoriatic arthritis.
• Bolesnici sa značajno oštećenom funkcijom koštane srži ili izraženom anemijom, leukopenijom,
- The other ingredients are: maize starch, povidone (E1201), crospovidone (E1202), silica colloidal anhydrous, magnesium stearate (E470b), and lactose monohydrate in the tablet core, as well as talc (E553b), hypromellose (E464), titanium dioxide (E171), and macrogol 8000 in the film-coating.
- Drugi sastojci su: kukuruzni škrob, povidon (E1201), krospovidon (E1202), bezvodni koloidni silicijev dioksid, magnezijev stearat (E470b) i laktoza hidrat u jezgri tablete te talk (E553b), hipromeloza (E464), titanijev dioksid (E171), makrogol 8000 i žuti željezov oksid (E172) u film ovojnici.
The long half-life of leflunomide should be considered when contemplating administration of a live attenuated vaccine after stopping Leflunomide Zentiva.
Kad se razmatra primjena živih atenuiranih cjepiva nakon prekida liječenja lijekom Leflunomide Zentiva, potrebno je uzeti u obzir dugi poluvijek leflunomida.
All of these also resolved, 2 with continuation of both medicinal products and 3 after discontinuation of leflunomide.
Sve su se te vrijednosti smanjile, u 2 bolesnika koji su nastavili istodobno uzimati oba lijeka i u 3 bolesnika koji su prekinuli uzimati leflunomid.
Both colestyramine and activated powdered charcoal may influence the absorption of oestrogens and progestogens such that reliable contraception with oral contraceptives may not be guaranteed during the washout procedure with colestyramine or activated powdered charcoal.
Stoga se kontracepcija oralnim kontraceptivima ne može smatrati pouzdanom tijekom postupka ispiranja u kojem se primjenjuje kolestiramin ili aktivni ugljen u prahu.
A randomised study assessed the clinical efficacy response rate in DMARD-naïve patients (n=121) with early RA, who received either 20 mg or 100 mg of leflunomide in two parallel groups during the initial three day double blind period.
Bolesnici su podijeljeni u dvije paralelne skupine i dobivali su ili 20 mg ili 100 mg leflunomida tijekom prva tri dana dvostruko slijepog ispitivanja.
Talc (E553b) Hypromellose (E464) Titanium dioxide (E171) Macrogol 8000
Ovojnica tablete: talk (E553b) hipromeloza (E464) titanijev dioksid (E171) makrogol 8000
Human pharmacology
Farmakologija u ljudi
Hepatic impairment
zatajenje bubrega
Vaccination with live attenuated vaccines is, however, not recommended.
Ne preporučuje se, međutim, cijepljenje živim atenuiranim cjepivima.
NAME OF THE MARKETING AUTHORISATION HOLDER
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit/risk aspects.
Nedavno ili istodobno liječenje hepatotoksičnim ili hematotoksičnim DMARD-ima (npr. metotreksatom) može povećati rizik od ozbiljnih nuspojava.
(pancytopenia), - severe increase in blood pressure, - inflammation of the lung (interstitial lung disease), - an increase in some liver results which may develop into serious conditions such as hepatitis and jaundice, - severe infections called sepsis which may be fatal, - an increase of certain enzymes in the blood (lactate dehydrogenase).
Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba): - porast broja krvnih stanica zvanih eozinofili (eozinofilija), blago smanjenje broja bijelih krvnih stanica (leukopenija), smanjenje broja svih krvnih stanica (pancitopenija), - značajan porast krvnog tlaka, - upala pluća (intersticijska plućna bolest), - porast vrijednosti određenih jetrenih enzima koji može dovesti do ozbiljnih stanja poput hepatitisa i žutice, - teške infekcije koje se nazivaju sepsa, a mogu dovesti do smrtnog ishoda, - porast vrijednosti određenih enzima u krvi (laktat dehidrogenaze).
Povidone (E1201) Crospovidone (E1202) Silica colloidal anhydrous Magnesium stearate (E470b) Lactose monohydrate
kukuruzni škrob povidon (E1201) krospovidon (E1202) silicijev dioksid, koloidni, bezvodni magnezijev stearat (E470b) laktoza hidrat
Hypromellose (E464) Titanium dioxide (E171) Macrogol 8000
hipromeloza (E464), titanijev dioksid (E171) i makrogol 8000 u film ovojnici.
3 film-coated tablets
50 filmom obloženih tableta
Silica colloidal anhydrous Magnesium stearate (E470b) Lactose monohydrate
bezvodni koloidni silicijev dioksid, magnezijev stearat (E470b) i laktoza hidrat u jezgri tablete,
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
U ispitivanjima faze III terapijske stope prema ACR-u bile su 54,6% za leflunomid 20 mg/dan naspram 28,6% za placebo (ispitivanje MN301), odnosno 49,4% naspram 26,3% (ispitivanje US301).
- colitis, - diarrhoea, - nausea, vomiting, - inflammation of the mouth or mouth ulcers, - abdominal pain, - an increase in some liver test results, - increased hair loss, - eczema, dry skin, rash, itching, - tendonitis (pain caused by inflammation in the membrane surrounding the tendons usually in the feet or hands), - an increase of certain enzymes in the blood (creatine phosphokinase), - problems in the nerves of the arms or legs (peripheral neuropathy).
- gubitak teka, gubitak težine (obično beznačajan), - umor (astenija), - glavobolja, omaglica, - neuobičajeni osjeti na koži, poput trnaca (parestezije), - blaži porast krvnog tlaka, - kolitis, - proljev, - mučnina, povraćanje, - upala ili čirevi u ustima, - bol u trbuhu, - porast vrijednosti određenih jetrenih enzima, - pojačan gubitak kose, - ekcem, suha koža, osip, svrbež, - tendinitis (bol izazvana upalom membrane koja okružuje tetive, obično na stopalima ili šakama), - porast koncentracije određenih enzima u krvi (kreatin fosfokinaze), - problemi sa živcima u rukama ili nogama (periferna neuropatija).
Leflunomide Zentiva 20 mg film-coated tablets are yellowish to ochre and triangular.
Kako Leflunomide Zentiva izgleda i sadržaj pakiranja Leflunomide Zentiva 20 mg filmom obložene tablete su žućkaste do oker boje i trokutastog oblika.
Leflunomide Zentiva 20 mg
16. PODACI NA BRAILLEOVOM PISMU Leflunomide Zentiva 20 mg
30 film-coated tablets 100 film-coated tablets
OBLIK I SADRŽAJ 30 filmom obloženih tableta 100 filmom obloženih tableta
In this trial, the loading dose and maintenance dose of leflunomide was based on three weight categories: <20 kg, 20-40 kg, and >40 kg. After 16 weeks treatment, the difference in response rates was statistically significant in favour of methotrexate for the JRA Definition of Improvement (DOI) ≥30% (p=0.02).
U ovom su se ispitivanju udarna doza i doza održavanja leflunomida zasnivale na 3 kategorije tjelesne težine: < 20 kg, 20-40 kg i > 40 kg.
Liver reactions
Jetrene reakcije
Leflunomide Zentiva 20 mg film-coated tablets leflunomide
Leflunomide Zentiva 20 mg filmom obložene tablete leflunomid
Each film-coated tablet contains 20 mg leflunomide.
Jedna filmom obložena tableta sadrži 20 mg leflunomida.
Leflunomide Zentiva 100 mg film-coated tablets leflunomide
Leflunomide Zentiva 100 mg filmom obložene tablete leflunomid
- if you have ever had an allergic reaction to leflunomide (especially a serious skin reaction,
Nemojte uzimati lijek Leflunomide Zentiva - ako ste ikada imali alergijsku reakciju na leflunomid (pogotovo tešku kožnu reakciju, često udruženu s vrućicom, bolovima u zglobovima, crvenim kožnim mrljama ili mjehurićima, npr.
Leflunomide Zentiva 10 mg
16. PODACI NA BRAILLEOVOM PISMU Leflunomide Zentiva 10 mg
Also contains lactose.
POPIS POMOĆNIH TVARI Također sadrži laktozu.
General disorders and administration site conditions Common:
Opći poremećaji i reakcije na mjestu primjene Često:
cysts and polyps) The risk of malignancy, particularly lymphoproliferative disorders, is increased with use of some immunosuppressive agents.
Neki od imunosupresivnih lijekova mogu povećati rizik od pojave tumora, osobito limfoproliferativnih poremećaja.
INSTRUCTIONS ON USE 16.
15. UPUTE ZA UPORABU
One film-coated tablet contains 100 mg of leflunomide.
Jedna filmom obložena tableta sadrži 100 mg leflunomida.
Leflunomide Zentiva 100 mg
16. PODACI NA BRAILLEOVOM PISMU Leflunomide Zentiva 100 mg
Each tablet contains 20 mg leflunomide.
TVARI Jedna tableta sadrži 20 mg leflunomida
• The Summary of Product Characteristics
• Sažetak opisa svojstava lijeka
Leflunomide Zentiva 10 mg film-coated tablets leflunomide
Leflunomide Zentiva 10 mg filmom obložene tablete leflunomid
- if you are male and wish to father a child. As it can not be excluded that Leflunomide Zentiva passes into semen, reliable contraception should be used during treatment with Leflunomide Zentiva.
Budući da se ne može isključiti izlučivanje lijeka Leflunomide Zentiva u spermu, tijekom terapije lijekom Leflunomide Zentiva treba primjenjivati učinkovitu kontracepciju.
One film-coated tablet contains 10 mg of leflunomide.
Jedna filmom obložena tableta sadrži 10 mg leflunomida.
Postmarketing studies
Ispitivanja nakon stavljanja lijeka u promet
Read the package leaflet before use.
NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
Talc (E553b) Hypromellose (E464) Titanium dioxide (E171) Macrogol 8000.
te talk (E553b), hipromeloza (E464), titanijev dioksid (E171) i makrogol 8000 u film ovojnici.
The time to peak plasma concentrations of A771726 is very variable; peak plasma levels can occur between 1 hour and 24 hours after single administration.
Vrijeme do postizanja vršne koncentracije A771726 u plazmi jako varira.
Each tablet contains 10 mg leflunomide.
TVARI Jedna tableta sadrži 10 mg leflunomida
Leflunomide Zentiva 20 mg film-coated tablets
NAZIV LIJEKA Leflunomide Zentiva 20 mg filmom obložene tablete
In either case it should be confirmed by a blood test that Leflunomide Zentiva has been sufficiently removed from your body and you should then wait for at least another month before you become pregnant.
U oba slučaja krvnim pretragama treba potvrditi da je Leflunomide Zentiva u dovoljnoj mjeri uklonjen iz Vašega organizma.
METHOD AND ROUTE(S) OF ADMINISTRATION
Ispiranje („washout“ postupak)
Crospovidone (E1202) Talc (E553b)
- Drugi sastojci su: kukuruzni škrob, povidon (E1201), krospovidon (E1202), talk (E553b),
EU/1/09/604/010 3 tablets
EU/1/09/604/002 100 tableta
Leflunomide Zentiva 100 mg film-coated tablets
NAZIV LIJEKA Leflunomide Zentiva 100 mg filmom obložene tablete
Very rare:
Vrlo rijetko: pankreatitis
EU/1/09/604/008 30 tablets EU/1/09/604/009 100 tablets
EU/1/09/604/009 100 tableta
The extent of leflunomide absorption is not affected if it is taken with food.
Istodobno uzimanje s hranom ne ometa apsorpciju leflunomida.
Reliable contraception during treatment with leflunomide should also be guaranteed.
Tijekom liječenja leflunomidom potrebno je koristiti učinkovitu kontracepciju.
- an increase in the numbers of blood cells called eosinophiles (eosinophilia); mild decrease in the number of white blood cells (leucopenia); decrease in the number of all blood cells
Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba): - blago smanjen broj bijelih krvnih stanica (leukopenija), - blage alergijske reakcije,
Leflunomide Zentiva 10 mg film-coated tablets
NAZIV LIJEKA Leflunomide Zentiva 10 mg filmom obložene tablete
Similarly, recent treatment with hepatotoxic or haematotoxic medicinal products (e.g. methotrexate) may result in increased side effects; therefore, the initiation of leflunomide treatment has to carefully be considered regarding these benefit/risk aspects and closer monitoring is recommended in the initial phase after switching.
Isto tako, nedavno provedeno liječenje hepatotoksičnim ili hematotoksičnim lijekovima (npr. metotreksatom) može dovesti do pojave većeg broja nuspojava.
EU/1/09/604/003 30 tablets EU/1/09/604/004 100 tablets
EU/1/09/604/004 100 tableta
Oral use.
Primjena kroz usta.
Elderly patients (≥ 65 years)
Stariji bolesnici (≥ 65 godina)
This leaflet was last revised in
Ova uputa je zadnji puta revidirana u
3 years
3 godine.
- The other ingredients are:
- Drugi sastojci su:
OTHER Do not open before use.
Ne otvarati prije uporabe.
Date of latest renewal: 23 September 2019
Datum posljednje obnove odobrenja: 23. rujna 2019
Similar results were observed in analyses using a conservative threshold of 10%.
Slični rezultati opaženi su u analizama u kojima je primijenjen konzervativni prag od 10%.
The treatment effect was consistent in both trials.
Učinak liječenja bio je konzistentan u oba ispitivanja.
It is recommended that you take the capsules with food, i.e. during or immediately before or after a meal.
Preporučeno je kapsule uzeti s hranom, tj. tijekom ili neposredno prije ili nakon obroka.
Based on a Log-rank test.
Temeljeno na log-rang testu.
Other medicines and Ofev
Drugi lijekovi i Ofev
Your doctor will discuss the results of these tests with you and decide whether you may receive Ofev.
Vaš liječnik će s Vama raspraviti rezultate ovih pretraga i odlučiti možete li primati Ofev.
Based on this information your doctor may do some blood tests, for example to check your liver function.
Na temelju ovih informacija Vaš liječnik može odlučiti napraviti krvne pretrage, primjerice da provjeri funkciju Vaše jetre.
No overall differences in safety and efficacy were observed for elderly patients.
Nisu primijećene ukupne razlike u sigurnosti i djelotvornosti u starijih bolesnika.
Studies in paediatric populations have not been performed.
Ispitivanja u pedijatrijskim populacijama nisu provedena.
It is important to take this medicine every day, as long as your doctor prescribes it for you.
Važno je da uzimate ovaj lijek svakog dana sve dok Vam ga Vaš liječnik propisuje.
Ofev can interact with certain other medicines.
Ofev može imati interakcije s nekim drugim lijekovima.
Allergic reaction
Alergijska reakcija
A risk to the newborns/infants cannot be excluded.
Rizik za novorođenče/dojenče se ne može isključiti.
Do not take two capsules together if you have forgotten to take your earlier dose.
Nemojte uzimati dvije kapsule odjednom, ako ste zaboravili uzeti prethodnu dozu.
Based on a logistic regression.
Temeljeno na logističkoj regresiji.
The overall recovery was considered complete (above 90%) within 4 days after dosing.
Cjelokupno izlučivanje smatralo se potpunim (iznad 90%) unutar 4 dana nakon doziranja.
Both patients recovered from these adverse reactions.
Oba bolesnika oporavila su se od tih nuspojava.
You should not drive or use machines if you feel sick.
Ne smijete upravljati vozilima i strojevima ako osjećate mučninu.
Always take this medicine exactly as your doctor or pharmacist has told you.
Uvijek uzmite ovaj lijek točno onako kako Vam je rekao liječnik ili ljekarnik.
UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom.
Survival analysis
Analiza preživljenja
What Ofev looks like and contents of the pack
Kako Ofev izgleda i sadržaj pakiranja
The age range covered by the analysis was 29 to 85 years; approximately 5% of the population were older than 75 years.
Raspon dobi pokriven ovom analizom iznosio je 29 do 85 godina; približno 5% populacije bilo je starije od 75 godina.
You should discuss the most appropriate methods of contraception for you with your doctor.
Sa svojim liječnikom morate raspraviti o najprikladnijim metodama kontracepcije za Vas.
The safety and efficacy of Ofev in children aged 0-18 years have not been established.
Sigurnost i djelotvornost Ofeva u djece u dobi od 0 - 18 godina nisu još ustanovljene.
The major route of elimination of drug related radioactivity after oral administration of [
Glavni put eliminacije radioaktivnosti vezane uz lijek nakon peroralne primjene [
Serum albumin is considered to be the major binding protein.
Serumski albumin se smatra glavnim proteinom vezanja.
UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM PC
The recommended maximum daily dose of 300 mg should not be exceeded.
Preporučena maksimalna dnevna doza od 300 mg ne smije se prekoračiti.
What Ofev is and what it is used for
Što je Ofev i za što se koristi
Package leaflet: Information for the patient
Uputa o lijeku: Informacije za bolesnika
Gastrointestinal adverse events were frequent and in line with the established safety profile of each component.
Gastrointestinalni štetni događaji bili su česti i u skladu s ustanovljenim sigurnosnim profilom za svaku od komponenata.