natgillin/translations-raw huggingface dataset:
Pulmonary symptoms, such as cough and dyspnoea, may be a reason for discontinuation of the therapy and for further investigation, as appropriate.
Simptomi koji zahvaćaju pluća, poput kašlja i dispneje, mogu biti razlogom za prekid terapije i daljnjih pretraga, ako je primjereno.
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.
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.
If ALT (SGPT) elevations of more than 2-fold the upper limit of normal persist or if ALT elevations of more than 3fold the upper limit of normal are present, leflunomide must be discontinued and wash-out procedures initiated.
Ako dvostruko veća koncentracija ALT (SGPT) u odnosu na gornju granicu normale potraje ili ako se ALT poveća više od 3 puta u odnosu na gornju granicu normale, liječenje leflunomidom valja prekinuti i započeti postupak ispiranja.
Repeated oral administration of leflunomide to mice for up to 3 months, to rats and dogs for up to 6 months and to monkeys for up to 1 month's duration revealed that the major target organs for toxicity were bone marrow, blood, gastrointestinal tract, skin, spleen, thymus and lymph nodes.
Ponavljana peroralna primjena leflunomida na miševima do tri mjeseca, štakorima i psima do 6 mjeseci te majmunima do jednog mjeseca pokazala je da je toksičnost najočitija na koštanoj srži, krvi, gastrointestinalnom sustavu, koži, slezeni, timusu i limfnim čvorovima.
Repeated doses of A771726 had no effect on the pharmacokinetics of S-warfarin, indicating that A771726 is not an inhibitor or an inducer of CYP2C9.
Ponovljene doze A771726 nisu imale učinak na farmakokinetiku S-varfarina, što ukazuje na to da A771726 nije niti inhibitor ni induktor CYP2C9.
• Patients with severe immunodeficiency states, e.g. AIDS.
• Bolesnici s teškim stanjima imunodeficijencije, npr. AIDS
If you are pregnant or become pregnant while taking Leflunomide ratiopharm, the risk of having a baby with serious birth defects is increased.
Ako ste trudni ili zatrudnite dok uzimate Leflunomid ratiopharm, rizik od ozbiljnih prirođenih mana u Vašeg djeteta je povećan.
hypouricemia
hipouricemija
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.
Kolestiramin u dozi od 8 g primijenjen peroralno 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.
The results of a population pharmacokinetic analysis of these trials have demonstrated that pediatric patients with body weights ≤40 kg have a reduced systemic exposure (measured by Css) of A771726 relative to adult rheumatoid arthritis patients (see section
Rezultati populacijske farmakokinetičke analize tih ispitivanja pokazuju da su pedijatrijski bolesnici tjelesne težine ≤ 40 kg imali smanjenu sistemsku izloženost (mjerenu s Css) A771726 u odnosu na odrasle bolesnike s reumatoidnim artritisom (vidjeti dio 4.2.).
• alternatively, 50 g of activated powdered charcoal is administered 4 times daily for a period of 11 days.
• alternativno, 50 g aktivnog ugljena u prahu 4 puta na dan tijekom 11 dana.
Take the tablet with plenty of water.
Tabletu progutajte cijelu s većom količinom vode.
• For psoriatic arthritis: 20 mg Leflunomide ratiopharm once daily.
• Za psorijatični artritis: 20 mg Leflunomida ratiopharm jedanput na dan.
The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Leflunomide ratiopharm are provided with a physician educational pack containing the following:
Nositelj odobrenja za stavljanje gotovog lijeka u promet dužan je osigurati da svi liječnici koji bi mogli propisivati/upotrebljavati Leflunomid ratiopharm dobiju edukacijski komplet za liječnike koji sadržava sljedeće:
Leflunomide ratiopharm is used to treat adult patients with active rheumatoid arthritis or with active psoriatic arthritis.
Leflunomid ratiopharm se primjenjuje za liječenje odraslih bolesnika s aktivnim oblikom reumatoidnog artritisa ili aktivnim oblikom psorijatičnog artritisa.
Women of childbearing potential must not take Leflunomide ratiopharm without using reliable contraceptive measures.
Žene reproduktivne dobi ne smiju uzimati Leflunomid ratiopharm ako ne koriste učinkovitu kontracepciju.
For other substrates of BCRP (e.g., methotrexate, topotecan, sulfasalazine, daunorubicin, doxorubicin) and the OATP family especially HMG-CoA reductase inhibitors (e.g., simvastatin, atorvastatin, pravastatin, methotrexate, nateglinide, repaglinide, rifampicin) concomitant administration should also be undertaken with caution.
Za ostale supstrate BCRP (npr. metotreksat, topotekan, sulfasalazin, daunorubicin, doksorubicin) i OATP obitelji, osobito inhibitore HMG-CoA reduktaze (npr. simvastatin, atorvastatin, pravastatin, metotreksat, nateglinid, repaglinid, rifampicin), istodobna primjena se također mora provoditi uz oprez.
Therefore, monitoring patients with concomitant use of medicinal products metabolised by CYP2C8, such as repaglinide, paclitaxel, pioglitazone or rosiglitazone, is recommended as they may have higher exposure.
Stoga, preporučuje se praćenje bolesnika koji istodobno uzimaju lijekove koje metabolizira CYP2C8, kao što su repaglinid, paklitaksel, pioglitazon ili roziglitazon, zbog moguće povećane izloženosti lijeku.
The PSUR submission schedule should follow the PSUR submission schedule for the reference medicinal product.
PSUR-evi Plan predavanja PSUR-a treba pratiti raspored prijave PSUR-a referentnog lijeka.
Leflunomide ratiopharm is contraindicated in pregnancy (see section
Leflunomid ratiopharm je kontraindiciran u trudnoći (vidjeti dio 4.3).
Infections and infestations Rare:
Infekcije i infestacije
How to store Leflunomide ratiopharm Contents of the pack and other information
Kako čuvati Leflunomid ratiopharm Sadržaj pakiranja i druge informacije
However, a 25% decrease in peak international normalised ratio (INR) was observed when A771726 was co-administered with warfarin as compared with warfarin alone.
Ipak, primjećeno je 25%-tno smanjenje vršne vrijednosti internacionalnog normaliziranog omjera (INR) kod istodobne primjene A771726 s varfarinom u usporedbi s monoterapijom varfarinom.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Bottle
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Bočica
• Patients with impairment of liver function.
• Bolesnici s oštećenom jetrenom funkcijom
Leflunomide ratiopharm is contraindicated in patients with severe hypoproteinaemia or impairment of liver function (see section 4.3).
Leflunomid ratiopharm je kontraindiciran u bolesnika s teškom hipoproteinemijom ili oštećenom jetrenom funkcijom (vidjeti dio 4.3.).
You will then need a blood test to make sure that Leflunomide ratiopharm has been sufficiently removed from your body, and you should then wait for at least another 3 months before attempting to father a child.
Trebat ćete napraviti krvne pretrage kako biste bili sigurni da je Leflunomid ratiopharm u dovoljnoj mjeri uklonjen iz tijela i nakon toga pričekati najmanje sljedeća 3 mjeseca prije pokušaja ostvarivanja očinstva.
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.
Primjenom aktivnog ugljena (prašak pripravljen kao suspenzija) peroralno 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.
Do not take Leflunomide ratiopharm when you are breast-feeding, as leflunomide passes into the breast milk.
Nemojte uzimati Leflunomid ratiopharm dok dojite jer se leflunomid izlučuje u majčino mlijeko.
• Hypersensitivity (especially previous Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) to the active substance, to the principal active metabolite teriflunomide, to peanut or soya or to any of the excipients listed in section 6.1.
• Preosjetljivost (osobito u slučaju ranijeg Stevens-Johnsonovog sindroma, toksične epidermalne nekrolize, multiformnog eritema) na djelatnu tvar, na glavni aktivni metabolit teriflunomid, na kikiriki ili soju ili neku od pomoćnih tvari navedenih u dijelu 6.1
• For rheumatoid arthritis: 10 or 20 mg Leflunomide ratiopharm once daily, depending on the severity of the disease.
• Za reumatoidni artritis: 10 mg ili 20 mg Leflunomida ratiopharm jedanput na dan, ovisno o težini bolesti.
The Marketing Authorisation Holder (MAH) shall ensure that any changes to the safety profile of the reference medicinal product requiring changes to the Risk Management Plan or Product Information are immediately implemented for Leflunomide ratiopharm.
Nositelj odobrenja za stavljanje gotovog lijeka u promet dužan je odmah implementirati sve promjene sigurnosnog profila referentnog lijeka, koje iziskuju promjene u Planu upravljanja rizicima ili Informacijama o lijeku za Leflunomid ratiopharm.
Effect on oral contraceptive (0.03 mg ethinylestradiol and 0.15 mg levonorgestrel) 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.
Učinak na oralne kontraceptive (0,03 mg etinilestradiol i 0,15 mg levonorgestrel) 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.
• The identified risk of synergistic hepato- or haematotoxicity associated with combination therapy with another Disease-Modifying Antirheumatic Drug (e.g. methotrexate)
• Prepoznat rizik od sinergije između hepatotoksičnosti ili hematotoksičnosti i kombinirane terapije s nekim drugim antireumatikom koji modificira tijek bolesti (primjerice metotreksatom).
What Leflunomide ratiopharm is and what it is used for
Što je Leflunomid ratiopharm i za što se koristi
This metabolite is responsible for essentially all the in-vivo activity of Leflunomide ratiopharm.
Taj je metabolit odgovoran za gotovo svu in vivo aktivnost leflunomida.
• Patients with severe hypoproteinaemia, e.g. in nephrotic syndrome.
• Bolesnici s teškom hipoproteinemijom, npr. kod nefrotskog sindroma
In a small (n=30) study with co-administration of leflunomide (10 to 20 mg per day) with methotrexate (10 to 25 mg per week) a 2- to 3-fold elevation in liver enzymes was seen on 5 of 30 patients.
U manjem ispitivanju (n=30) istodobne primjene leflunomida (10 do 20 mg na dan) i metotreksata (10 do 25 mg na tjedan) opaženo je povišenje jetrenih enzima 2 do 3 puta u 5 od 30 bolesnika.
As soon as skin and/or mucosal reactions are observed which raise the suspicion of such severe reactions, Leflunomide ratiopharm and any other possibly associated treatment must be discontinued, and a leflunomide washout procedure initiated immediately.
Čim se pojave reakcije na koži i/ili sluznici koje izazivaju sumnju na teške nuspojave, uzimanje Leflunomida ratiopharm ili bilo kojeg dodatnog lijeka treba prekinuti i odmah započeti postupak ispiranja leflunomida.
- rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol) sulfasalazine for inflammatory bowel disease or rheumatoid arthritis a medicine called colestyramine (used to reduce high cholesterol) or activated charcoal as these medicines can reduce the amount of Leflunomide ratiopharm which is absorbed by the body.
- zidovudin za liječenje HIV-infekcije - rozuvastatin, simvastatin, atorvastatin, pravastatin za liječenje hiperkolesterolemije (povišeni kolesterol) - sulfasalazin za liječenje upalne bolesti crijeva ili reumatoidnog artritisa lijek koji se zove kolestiramin (primjenjuje se za snižavanje visokog kolesterola) ili aktivni ugljen jer ti lijekovi mogu smanjiti količinu lijeka Leflunomid ratiopharm koju tijelo apsorbira,
An in vivo interaction study with leflunomide and cimetidine (non-specific weak cytochrome P450 (CYP) inhibitor) has demonstrated a lack of a significant impact on A771726 exposure.
U in vivo ispitivanjima interakcija s leflunomidom i cimetidinom (nespecifičnim inhibitorom citokroma P450 (CYP)) nije opažen značajan utjecaj na izloženost A771726.
In case of severe haematological reactions, including pancytopenia, Leflunomide ratiopharm and any concomitant myelosuppressive treatment must be discontinued and a leflunomide washout procedure initiated.
U slučaju teških hematoloških reakcija, uključujući pancitopeniju, treba prekinuti liječenje Leflunomidom ratiopharm i bilo kojim istodobno primijenjenim mijelosupresivnim lijekom te početi postupak ispiranja leflunomida.
Leflunomide, administered orally and intraperitoneally, has been studied in acute toxicity studies in mice and rats.
Akutna toksičnost leflunomida, primijenjenog peroralno i intraperitonealno, ispitivana je na miševima i štakorima.
If you are already taking a nonsteroidal anti-inflammatory drug (NSAID) and/or corticosteroids, you may continue to take them after starting Leflunomide ratiopharm.
Ako već uzimate nesteroidne protuupalne lijekove (NSAIL) i/ili kortikosteroide, možete ih nastaviti uzimati nakon što počnete uzimati Leflunomid ratiopharm.
Studies with both hemodialysis and CAPD (chronic ambulatory peritoneal dialysis) indicate that A771726, the primary metabolite of leflunomide, is not dialysable
Studije s hemodijalizom i kroničnom ambulantnom peritonealnom dijalizom upućuju da se A771726, primarni metabolit leflunomida, ne može dijalizirati.
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.
Farmakokinetika A771726 nakon peroralne primjene leflunomida ispitivana je u 73 pedijatrijska bolesnika u dobi od 3 do 17 godina s poliartikuliranim oblikom juvenilnog reumatoidnog artritisa (JRA).
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.
Osim toga, prijelaz s leflunomida na neki drugi DMARD, bez provedbe postupka ispiranja (engl. „washout“) leflunomida (vidjeti dio 4.4.), također može povećati rizik od ozbiljnih nuspojava, čak i dulje vrijeme nakon promjene lijeka.
• 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, neutropenijom ili trombocitopenijom, koje nisu uzrokovane reumatoidnim ili psorijatičnim artritisom
If you forget to take Leflunomide ratiopharm
Ako ste zaboravili uzeti Leflunomid ratiopharm
White to almost white, round film-coated tablet with a diameter of about 6 mm.
Bijela do gotovo bijela okrugla, filmom obložena tableta promjera oko 6 mm.
- The other ingredients are lactose monohydrate, low-substituted hydroxypropyl cellulose, tartaric acid, sodium laurylsulfate and magnesium stearate in the tablet core as well as lecithin (soybeans), poly(vinyl alcohol), talc, titanium dioxide (E171) and xanthan gum in the film-coating
- Drugi sastojci su laktoza hidrat, niskosupstituirana hidroksipropilceluloza, tartaratna kiselina, natrijev laurilsulfat i magnezijev stearat u jezgri tablete, kao i lecitin (zrna soje), poli(vinilni alkohol), talk, titanijev dioksid (E171) i ksantanska guma u film-ovojnici.
In the phase III trials, the ACR response rates for leflunomide 20 mg/day versus placebo were 54.6% vs. 28.6% (study MN301), and 49.4% vs. 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 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.
The patient must be advised that if there is any delay in onset of menses or any other reason to suspect pregnancy, they must notify the physician immediately for pregnancy testing, and if positive, the physician and patient must discuss the risk to the pregnancy.
Bolesnice treba savjetovati da u slučaju kašnjenja menstruacije ili sumnje na trudnoću odmah moraju obavijestiti liječnika zbog provođenja testa na trudnoću.
toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
Vrlo rijetko: toksična epidermalna nekroliza, Stevens-Johnsonov sindrom, multiformni eritem
Your doctor will carry out blood tests at regular intervals, before and during treatment with Leflunomide ratiopharm, to monitor your blood cells and liver.
Prije i za vrijeme liječenja Leflunomid ratiopharmm liječnik će Vas u redovitim razmacima slati na krvne pretrage zbog kontrole Vaših krvnih stanica i jetre.
A771726 plasma levels can be expected to be above 0.02 mg/L for a prolonged period.
Očekuje se da će se koncentracija A771726 u plazmi, viša od 0,02 mg/l, zadržati duže vrijeme.
Each film-coated tablet contains 76 mg of lactose and 0.06 mg of soya lecithin.
Jedna filmom obložena tableta sadrži 76 mg laktoze i 0,06 mg sojinog lecitina.
Leflunomide ratiopharm contains the active substance leflunomide which belongs to a group of medicines called anti-rheumatic medicines.
Leflunomid ratiopharm sadrži djelatnu tvar leflunomid koja pripada skupini antireumatskih lijekova.
Tell your doctor immediately if you experience: - pale skin, tiredness, or bruising, as these may indicate blood disorders caused by an imbalance in the different types of blood cells which make up blood, - tiredness, abdominal pain, or jaundice (yellow discolouration of the eyes or skin), as these may indicate serious conditions such as liver failure, which may be fatal, - any symptoms of an infection such as fever, sore throat or cough, as this medicine may increase the chance of a severe infection which may be life-threatening, - cough or breathing problems as these may indicate problems of the lung (interstitial lung disease or pulmonary hypertension), - unusual tingling, weakness or pain in your hands or feet as these may indicate problems with your nerves (peripheral neuropathy).
Odmah obavijestite svog liječnika u slučaju: - bljedoće kože, umora ili pojave modrica jer to može upućivati na krvne poremećaje uzrokovane poremećenom ravnotežom različitih vrsta krvnih stanica, - umora, boli u trbuhu ili žutice (žuta boja bjeloočnica ili kože) jer to može upućivati na teška stanja kao što je zatajenje jetre, koje može dovesti do smrtnog ishoda, - bilo kojeg simptoma infekcije kao što su vrućica, grlobolja ili kašalj jer ovaj lijek može povećati rizik od teških infekcija koje mogu biti opasne po život. - kašlja ili problema s disanjem budući da ovi problemi mogu ukazivati na probleme s plućima (intersticijska bolest pluća ili plućna hipertenzija) - neuobičajenih trnaca, slabosti li bolova u šakama ili stopalima jer mogu upućivati na probleme sa živcima (periferna neuropatija).
What Leflunomide ratiopharm is and what it is used for What you need to know before you take Leflunomide ratiopharm How to take Leflunomide ratiopharm Possible side effects
Što Leflunomid ratiopharm i za što se koristi Što morate znati prije nego počnete uzimati Leflunomid ratiopharm
Other side effects such as kidney failure, a decrease in the levels of uric acid in your blood, pulmonary hypertension, male infertility (which is reversible once treatment with this medicine is stopped), cutaneous lupus (characterized by rash/erythema on skin areas that are exposed to light), psoriasis (new or worsening) and DRESS may also occur with a not known frequency.
Druge nuspojave kao što su zatajenje bubrega, pad razine mokraćne kiseline u krvi, plućne hipertenzije, muška neplodnost (koja je reverzibilna nakon prestanka liječenja ovim lijekom), kožni lupus (karakteriziran osipom/crvenilom na područjima kože izloženima svjetlu), psorijaza (novonastala psorijaza ili pogoršanje psorijaze) i reakcije na lijek s eozinofilijom i sistemskim simptomima (DRESS) također se mogu javiti, a njihova učestalost nije poznata.
Tell your doctor immediately and stop taking Leflunomide ratiopharm: if you experience weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic reaction, 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.
Odmah obavijestite svog liječnika i prestanite uzimati Leflunomid ratiopharm: - ako osjetite slabost, ošamućenost ili omaglicu ili imate poteškoće s disanjem jer to mogu biti znaci ozbiljne alergijske reakcije, - 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.
Each film-coated tablet contains 152 mg of lactose and 0.12 mg of soya lecithin.
Jedna filmom obložena tableta sadrži 152 mg laktoze i 0,12 mg sojinog lecitina.
Repeated doses of A771726 decreased mean Cmax and AUC of caffeine (CYP1A2 substrate) by 18% and 55%, respectively, suggesting that A771726 may be a weak inducer of CYP1A2 in vivo.
Ponovljene doze A771726 smanjile su prosječnu Cmax i AUC kofeina (CYP1A2 supstrat) za 18%, odnosno za 55%, što ukazuje na to da bi A771726 mogao biti slabi induktor CYP1A2 in vivo.
Talk to your doctor, pharmacist or nurse before taking Leflunomide ratiopharm - if you have ever suffered from interstitial lung disease.
Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Leflunomid ratiopharm - ako ste ikad imali intersticijsku plućnu bolest.
Leflunomide ratiopharm 20 mg
Leflunomid ratiopharm 20 mg
Leflunomide ratiopharm 10 mg
Leflunomid ratiopharm 10 mg
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.
Ako nije moguće čekati dvije godine uz odgovarajuću kontracepciju, preporučuje se profilaktički započeti ispiranje (engl. "washout").
Titanium dioxide (E171) Xanthan gum
Film-ovojnica lecitin (zrna soje) poli(vinilni) alkohol talk titanijev dioksid (E171) ksantanska guma
There was an increase in mean rosuvastatin Cmax and AUC (2.65- and 2.51-fold, respectively), following repeated doses of A771726.
Zabilježeno je povećanje prosječne Cmax i AUC (2,65 odnosno 2,51 puta) za rosuvastatin nakon ponovljenih doza A771726.
At a dose level of 20 mg/day, average plasma concentration of A771726 at steady state is approximately
Pri dozi od 20 mg/dan prosječna koncentracija A771726 u plazmi u stanju dinamičke ravnoteže iznosila je oko 35 μg/ml.
Marketing Authorisation Holder ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Germany
Nositelj odobrenja za stavljanje gotovog lijeka u promet ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Njemačka