natgillin/translations-raw huggingface dataset:
At steady state, bosentan plasma concentrations were 3- to 4-fold higher than with bosentan alone.
U stanju dinamičke ravnoteže koncentracije bosentana u plazmi bile su 3 do 4 puta više nego kod primjene samog bosentana.
This was a double-blind, placebo-controlled, randomised study in pre-term or term neonates (gestational age 36-42 weeks) with PPHN.
FUTURE 4 je bila dvostruko slijepa, placebom kontrolirana, randomizirana studija u nedonoščadi ili donošene novorođenčadi (gestacijske dobi 36-42 tjedna) s PPHN.
When co-administered, initial trough concentrations of bosentan were approximately 30-fold higher than those measured after bosentan alone.
Kod istodobne primjene početne najniže koncentracije bosentana bile su 30 puta više od onih koje su izmjerene nakon primjene samog bosentana.
In patients with evidence of the presence of cholestasis, the exposure to the active metabolite may be increased.
Izloženost aktivnom metabolitu može se povećati kod bolesnika kod kojih je dokazano prisustvo kolestaze.
PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets.
PVC/PE/PVDC/aluminij blisteri sadrže 14 filmom obloženih tableta.
STAYVEER 62.5 mg film-coated tablets PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets.
STAYVEER 62,5 mg filmom obložene tablete PVC/PE/PVDC/aluminij blisteri koji sadrže 14 filmom obloženih tableta.
Treatment with bosentan has been associated with dose-related decreases in haemoglobin concentration (see section 4.8).
Liječenje bosentanom povezano je sa smanjenjem koncentracije hemoglobina ovisnim o dozi (vidjeti dio 4.8).
Pulmonary veno-occlusive disease
Okluzivna bolest plućnih vena
Recommended dose Adult
Preporučena doza
5 Oedema or fluid retention was reported in 13.2% of patients on bosentan and 10.9% of patients on placebo.
Edem ili retencija tekućine prijavljeni su u 13,2% bolesnika koji su dobivali bosentan i 10,9% bolesnika koji su dobivali placebo.
• Some patients taking STAYVEER have been found to have abnormal liver function tests and anaemia (low haemoglobin).
Kod nekih bolesnika koji uzimaju STAYVEER utvrđeni su abnormalni testovi funkcije jetre te anemija (snižena koncentracija hemoglobina).
It is important that you have these regular blood tests as long as you are taking STAYVEER.
Važno je da tijekom uzimanja STAYVEERA provodite redovite krvne pretrage.
Pulmonary arterial hypertension patients with concomitant left ventricular failure
Bolesnici s plućnom arterijskom hipertenzijom i istodobnim zatajenjem lijevog ventrikula
Anaemia, haemoglobin decrease, (see section 4.4)
Anemija, smanjenje koncentracije hemoglobina, (vidjeti dio 4.4)
A Patient Alert Card providing important safety information that patients need to be aware of before and during treatment with STAYVEER is included in the pack.
U pakiranje lijeka uključena je Kartica s upozorenjima za bolesnika koja sadrži važne sigurnosne informacije kojih bolesnici moraju biti svjesni prije i tijekom liječenja lijekom STAYVEER.
2 Hypersensitivity reactions were reported in 9.9% of patients on bosentan and 9.1% of patients on placebo.
Reakcije preosjetljivosti prijavljene su u 9,9% bolesnika koji su dobivali bosentan i u 9,1% bolesnika koji su dobivali placebo.
Warnings and precautions Tests your doctor will do before treatment
Nalazi koje će Vaš liječnik zatražiti prije liječenja
In the FUTURE-4 study including 13 neonates with PPHN treated with bosentan 2 mg/kg twice daily for less than 10 days (range 0.5-10.0 days), there were no cases of liver aminotransferases ≥ 3 × ULN
U FUTURE-4 studiji koja je uključila 13 novorođenčadi s PPHN-om liječene bosentanom u dozi od 2 mg/kg dvaput dnevno kraće od 10 dana (raspon 0,5-10,0 dana) nije bilo slučajeva s porastom razine jetrenih aminotransferaza ≥ 3 × GGN tijekom liječenja, ali se pojavio jedan slučaj hepatitisa 3 dana nakon završetka liječenja bosentanom.
The plasma concentrations of bosentan were not affected by concomitant simvastatin.
Istodobna primjena simvastatina nije utjecala na koncentracije bosentana u plazmi.
Adverse events of liver abnormalities and anaemia/haemoglobin decrease occurred in 9% and 5% of patients, respectively.
Štetan događaj poremećaja funkcije jetre javio se u 9%, a anemija/smanjenje razine hemoglobina u 5% bolesnika.
Warfarin: Co-administration of bosentan 500 mg twice daily for 6 days decreased the plasma concentrations of both S-warfarin (a CYP2C9 substrate) and R-warfarin (a CYP3A4 substrate) by 29% and 38%, respectively.
Varfarin: istodobnom primjenom bosentana 500 mg dvaput dnevno tijekom 6 dana smanjila se koncentracija u plazmi S-varfarina (supstrat za CYP2C9) i R-varfarina (supstrat CYP3A4) za 29%,
A 2-year carcinogenicity study in mice showed an increased combined incidence of hepatocellular adenomas and carcinomas in males, but not in females, at plasma concentrations about 2 to 4 times the plasma concentrations achieved at the therapeutic dose in humans.
5.3 Neklinički podaci o sigurnosti primjene Dvogodišnja studija kancerogenosti na miševima pokazala je povećanu kombiniranu učestalost hepatocelularnih adenoma i karcinoma u mužjaka, ali ne i ženki, kod koncentracija u plazmi koje su 2 do 4 puta veće od onih koje se postižu kod terapijskih doza u ljudi.
Patients were treated with bosentan 62.5 mg twice daily for 4 weeks followed by 125 mg twice daily for a further 12 weeks.
Bolesnici su dobivali bosentan 62,5 mg dvaput dnevno tijekom 4 tjedna, a potom 125 mg dvaput dnevno tijekom daljnjih 12 tjedana.
Some patients taking STAYVEER were found to have abnormal liver function tests.
Neki bolesnici koji su uzimali STAYVEER, imali su promijenjene nalaze jetrene funkcije.
STAYVEER 125 mg film-coated tablets PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets.
STAYVEER 125 mg filmom obložene tablete PVC/PE/PVDC/aluminij blisteri koji sadrže 14 filmom obloženih tableta.
Glibenclamide: Co-administration of bosentan 125 mg twice daily for 5 days decreased the plasma concentrations of glibenclamide (a CYP3A4 substrate) by 40%, with potential significant decrease of the hypoglycaemic effect.
Glibenklamid: istodobna primjena bosentana 125 mg dvaput dnevno tijekom 5 dana smanjila je koncentraciju glibenklamida u plazmi (supstrat za CYP3A4) za 40%, s mogućim značajnim smanjenjem hipoglikemijskog učinka.
In adult patients, STAYVEER treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily.
Kod odraslih bolesnika, liječenje STAYVEEROM treba započeti dozom od 62,5 mg dvaput dnevno u trajanju od 4 tjedna i potom povećati na dozu održavanja od 125 mg dvaput dnevno.
In study AC-052-365 (FUTURE 1), dispersible tablets were administered in 36 PAH children aged from 2 to 11 years.
U studiji AC-052-365 (FUTURE 1) 36 djece s PAH-om u dobi od 2 do 11 godina primalo je tablete za oralnu suspenziju.
The aetiology of PAH, according to Dana Point classification, included idiopathic PAH (46%), heritable PAH (3%), associated PAH after corrective cardiac surgery (38%), and PAH related to congenital heart disease associated with systemic-topulmonary shunts, including Eisenmenger syndrome (13%).
PAH (46%), nasljedni PAH (3%), udruženi PAH nakon korektivne operacije srca (38%) te PAH
STAYVEER treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily.
Liječenje STAYVEEROM treba započeti dozom od 62,5 mg dvaput dnevno u trajanju od 4 tjedna i potom povećati na dozu održavanja od 125 mg dvaput dnevno.
The accumulation of bosentan in hepatocytes leading to cytolysis with potentially severe damage of the liver, or an immunological mechanism, are not excluded.
Nije isključen ni imunološki mehanizam niti nakupljanje bosentana u hepatocitima koje dovodi do citolize s potencijalnim teškim oštećenjem jetre.
However, there was no evidence of bosentan affecting thyroid function (thyroxine, TSH) in humans.
Kod ljudi nije dokazan utjecaj bosentana na funkciju štitnjače (tiroksin, TSH).
Package leaflet: Information for the user STAYVEER 62.5 mg film-coated tablets
Uputa o lijeku: Informacije za korisnika STAYVEER 62,5 mg filmom obložene tablete bosentan
Tacrolimus, sirolimus: Co-administration of tacrolimus or sirolimus and STAYVEER has not been studied in man but co-administration of tacrolimus or sirolimus and STAYVEER may result in increased plasma concentrations of bosentan in analogy to co-administration with cyclosporine A. Concomitant STAYVEER may reduce the plasma concentrations of tacrolimus and sirolimus.
Takrolimus, sirolimus: istodobna primjena takrolimusa ili sirolimusa sa STAYVEEROM nije ispitana u ljudi, ali istodobna primjena takrolimusa ili sirolimusa sa STAYVEEROM kao i kod ciklosporina
Skin and subcutaneous disorders Common
Poremećaji kože i potkožnog tkiva
On day 9, plasma concentrations of bosentan were approximately 5-fold higher than with bosentan administered alone.
Deveti dan koncentracije bosentana u plazmi bile su približno 5 puta više od onih izmjerenih nakon primjene bosentana samostalno.
Concomitant use of STAYVEER and cyclosporine A is contraindicated (see sections 4.3 and 4.5).
Istodobna primjena s drugim lijekovima Kontraindicirana je istodobna primjena STAYVEERA s ciklosporinom A (vidjeti dio 4.3 i 4.5).
Immune system disorders
Poremećaji imunološkog sustava Često
Simvastatin: Co-administration of bosentan 125 mg twice daily for 5 days decreased the plasma concentrations of simvastatin (a CYP3A4 substrate) and its active β-hydroxy acid metabolite by 34% and 46%, respectively.
Simvastatin: istodobna primjena bosentana 125 mg dvaput dnevno tijekom 5 dana dovela je do smanjenja koncentracija simvastatina u plazmi (susptrat CYP3A4) te njegovog aktivnog β-hidroksikiselinskog metabolita za 34%, odnosno 46%.
Cartons contain 56 or 112 film-coated tablets.
Kutije sadrže 56 ili 112 filmom obloženih tableta.
Oral use Read the package leaflet before use
Prije uporabe pročitajte uputu o lijeku
Consequently, should signs of pulmonary oedema occur when STAYVEER is administered in patients with PAH, the possibility of associated venoocclusive disease should be considered.
STAYVEERA u bolesnika s PAH-om, treba razmotriti mogućnost okluzivne bolesti vena.
Signs that your liver may not be working properly include:
Znakovi oštećenja funkcije jetre uključuju:
In a randomised, double-blind, multi-centre, placebo-controlled study (AC-052-364 [EARLY]), 185 PAH patients in WHO functional class II (mean baseline 6-minute walk distance of 435 metres) received bosentan 62.5 mg twice daily for 4 weeks followed by 125 mg twice daily (n = 93), or placebo (n = 92) for 6 months.
364 [EARLY]) 185 bolesnika s PAH-om WHO funkcionalnog stupnja II (srednja početna vrijednost udaljenosti prijeđene šestominutnim hodanjem od 435 metara) dobivali su bosentan 62,5 mg dvaput dnevno tijekom 4 tjedna, a potom 125 mg dvaput dnevno (n = 93) ili placebo (n = 92)
Treatment should only be initiated and monitored by a physician experienced in the treatment of systemic sclerosis.
Liječenje treba započeti i nadzirati jedino liječnik s iskustvom u liječenju plućne arterijske hipertenzije ili sistemske skleroze.
A reduction in symptoms of PAH was observed with bosentan treatment.
Kod liječenja bosentanom primijećeno je smanjenje simptoma PAH-a.
Women of childbearing age
Žene reproduktivne dobi
1 Data derived from post-marketing experience, frequencies based on statistical modelling of placebo-controlled clinical trial data.
Edem, retencija tekućine5 1 Podaci dobiveni iz razdoblja nakon stavljanja lijeka u promet, učestalosti se temelje na statističkom modeliranju podataka iz placebom kontroliranog kliničkog istraživanja.2
Consequently, plasma concentrations of substances metabolised by these isoenzymes will be decreased when STAYVEER is co-administered.
Stoga su koncentracije tvari koje metaboliziraju ti izoenzimi kod istodobne primjene STAYVEERA smanjene u plazmi.
STAYVEER 62.5 mg film-coated tablets Each film-coated tablet contains 62.5 mg bosentan (as monohydrate).
STAYVEER 62,5 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 62,5 mg bosentana (u obliku bosentan hidrata).
Patients in need of the combination should be closely monitored for adverse events related to STAYVEER and for tacrolimus and sirolimus blood concentrations.
Bolesnike kojima je potrebna kombinacija tih lijekova treba pažljivo nadzirati s obzirom na pojavu nuspojava vezanih za STAYVEER te s obzirom na koncentracije takrolimusa ili sirolimusa u plazmi.
> 3 and ≤ 5 × ULN The result should be confirmed by a second liver test; if confirmed, a decision should be made on an individual basis to continue STAYVEER, possibly at a reduced dose, or to stop STAYVEER administration (see section 4.2).
> 3 i ≤ 5 × GGN Nalaz treba potvrditi drugim testom jetrene funkcije; ako je potvrđeno, donijeti odluku za svakog bolesnika ponaosob da li nastaviti liječenje
Package leaflet: Information for the user STAYVEER 125 mg film-coated tablets
Uputa o lijeku: Informacije za korisnika STAYVEER 125 mg filmom obložene tablete bosentan
Cyclosporine A: Co-administration of STAYVEER and cyclosporine A (a calcineurin inhibitor) is contraindicated (see section 4.3).
Ciklosporin A: istodobna primjena STAYVEERA i ciklosporina A (inhibitor kalcineurina)
Transfer to a therapy that is recommended at the severe stage of the disease (e.g., epoprostenol) should be considered if the clinical condition deteriorates (see section 4.2).
Ako se kliničko stanje pogorša, treba razmotriti prijelaz na terapiju koja se preporučuje u teškoj fazi bolesti (npr.
Liver cirrhosis, liver failure1
Ciroza jetre, zatajenje jetre1
Therefore, if you feel dizzy or that your vision is blurred while taking STAYVEER, do not drive or operate any tools or machines.
Zato, ako osjećate omaglicu ili primijetite zamagljen vid tijekom uzimanja STAYVEERA
There was evidence of a mild thyroid hormonal imbalance induced by bosentan in rats.
Kod štakora je dokazan blagi hormonski poremećaj štitnjače induciran bosentanom.
Because STAYVEER may make hormonal contraception (e.g., oral, injection, implant, or skin patches) ineffective, this method on its own is not reliable.
Budući da STAYVEER smanjuje učinkovitost hormonske kontracepcije (npr. tablete, u obliku injekcije, implantata ili kožnih flastera),
• jaundice (yellowing of your skin or the whites of your eyes)
• žutica (žutilo kože ili bjeloočnica očiju) • tamno obojenu mokraću
- STAYVEER 62.5 mg film-coated tablets: The active substance is bosentan as monohydrate.
- STAYVEER 62,5 mg filmom obložene tablete: Djelatna tvar je bosentan u obliku bosentan hidrata.
The mean duration of exposure to bosentan was 1.9 years ± 0.7 years (min: 0.1 years; max: 3.3 years) and patients were observed for a mean of 2.0 ± 0.6 years.
(min.: 0,1 godina; maks.: 3,3 godine), a bolesnici su praćeni tijekom 2,0 ± 0,6 godina.
STAYVEER 125 mg film-coated tablets Each film-coated tablet contains 125 mg bosentan (as monohydrate).
STAYVEER 125 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 125 mg bosentana (u obliku bosentan hidrata).
Uncommon (may affect up to one in 100 people):
Manje česte (mogu se pojaviti u do 1 na 100 osoba):
STAYVEER 62.5 mg film-coated tablets STAYVEER 125 mg film-coated tablets
STAYVEER 62,5 mg filmom obložene tablete STAYVEER 125 mg filmom obložene tablete
STAYVEER 125 mg tablets bosentan
STAYVEER 125 mg tablete bosentan
Bosentan is an inducer of the cytochrome P450 (CYP) isoenzymes CYP2C9 and CYP3A4.
Bosentan inducira izoenzime citokroma P450 (CYP), CYP2C9 i CYP3A4.
Marketing authorisation holder:
Nositelj odobrenja za stavljanje lijeka u promet:
Though the number of patients included was limited and with high variability, these data indicate a marked increase in the exposure to bosentan and its primary metabolite Ro 485033 in patients with moderate liver function impairment (Child-Pugh class B).
Iako je broj uključenih bolesnika bio ograničen i s visokom varijabilnošću, ovi podaci naznačuju značajno povećanje izloženosti bosentanu i njegovom primarnom metabolitu
STAYVEER 62.5 mg tablets bosentan
STAYVEER 62,5 mg tablete bosentan
Birth control based on hormones - such as oral contraceptives or birth control pills, hormone injections, implants, or birth control skin patches don't reliably prevent pregnancy in women who are taking STAYVEER.
Metoda hormonske kontracepcije npr. uzeta kroz usta, u obliku injekcija, implantata ili flastera nije pouzdana u žena koje uzimaju lijek STAYVEER.
The Kaplan-Meier event-free estimate for worsening of PAH (death, lung transplantation, or hospitalisation for PAH worsening) at 2 years was 78.9%.
Kaplan-Meierova procjena preživljenja bez događaja pogoršanja PAH-a (smrt, transplantacija pluća ili hospitalizacija zbog pogoršanja PAH-a)
Development of testicular tubular atrophy and impaired fertility has been linked with chronic administration of endothelin receptor antagonists in rodents.
U glodavaca je kronična primjena antagonista endotelinskih receptora povezana s razvojem tubularne atrofije testisa i smanjenjem plodnosti.
No effect of bosentan on time to healing of digital ulcers was observed in either study.
Ni u jednoj studiji nije zapažen učinak bosentana na vrijeme zacjeljivanja ulceracija prstiju.
Pulmonary arterial hypertension
Plućna arterijska hipertenzija za koju je namijenjen
• flu-like syndrome (joint and muscle pain with fever)
• bezvoljnost ili umor (neuobičajen osjećaj umora ili iscrpljenosti) • sindrom sličan gripi (bol u zglobovima i mišićima s vrućicom)
In a randomised placebo-controlled study, conducted in PPHN patients (FUTURE-4), a total of 13 neonates were treated with the bosentan dispersible tablet formulation at a dose of 2 mg/kg twice daily (8 patients were on placebo).
(FUTURE-4) ukupno je 13 novorođenčadi liječeno bosentanom u obliku tablete za oralnu suspenziju u dozi od 2 mg/kg dvaput dnevno (8 bolesnika primalo je placebo).
At steady state, AUCτ was 6,165 ng·h/mL (CV: 133%, n = 7), which is similar to the exposure observed in adult PAH patients receiving 125 mg twice daily and taking into account a blood/plasma distribution ratio of 0.6.
n = 7), što je slično izloženosti zabilježenoj u odraslih bolesnika s PAH-om koji su primali 125 mg dvaput dnevno i uzimajući u obzir omjer distribucije u krvi i plazmi od 0,6.
If the aminotransferase levels return to pre-treatment values continuing or re-introducing STAYVEER according to the conditions described below should be considered.
Ako se vrijednosti aminotransferaza vrate na vrijednosti prije liječenja, treba razmotriti nastavak ili ponovno liječenje
• a blood test to check for anaemia (low haemoglobin)
• krvni nalazi za provjeru funkcije Vaše jetre • krvni nalazi za provjeru anemije (snižena koncentracija hemoglobina)
Therefore, concomitant use of STAYVEER and tacrolimus or sirolimus is not advisable.
STAYVEERA i takrolimusa ili sirolimusa ne preporuča.
• Diarrhoea
• Glavobolja
The most frequent adverse reactions are headache (11.5%), oedema / fluid retention (13.2%), abnormal liver function test (10.9%) and anaemia / haemoglobin decrease (9.9%).
Najčešće nuspojave bile su glavobolja (11,5%), edem / zadržavanje tekućine (13,2%), promijenjeni nalazi jetrene funkcije
It may harm them, even if their signs of illness are the same as yours.
Ro 48-5033 bio je 106 (58,4-192) ng⋅h/ml, tj. 12,4 puta viši nego kod bolesnika s normalnom funkcijom jetre (bosentan: srednji [95% CI] AUC: 76,1 [9,07-638] ng⋅h/ml; Ro 48 5033: srednji [95% CI] AUC 8,57 [1,28-57,2] ng⋅h/ml).
Due to the marked hepatotoxicity of nevirapine, which could add to bosentan liver toxicity, this combination is not recommended.
Kombinacija nevirapina i bosentana se ne preporučuje zbog izrazite hepatotoksičnosti nevirapina koja bi mogla pojačati hepatotoksičnost bosentana.
The NOAEL was 21 times (at Day 21 post partum) and 2.3 times (Day 69 post partum) the human therapeutic exposure, respectively.
odnosno 2,3 puta (na 69. postpartalni dan) veća od terapijske izloženosti u ljudi.
Inhibition by ritonavir of transport protein-mediated uptake into hepatocytes and of CYP3A4, thereby reducing the clearance of bosentan, most likely causes this interaction.
Najvjerojatniji je uzrok te interakcije inhibicija ritonavirom transportnog proteina kojim se bosentan unosi u hepatocite te CYP3A4, reducirajući pritom klirens bosentana.
STAYVEER 125 mg film-coated tablets Orange-white, oval, biconvex, film-coated tablets, embossed with “125” on one side.
STAYVEER 125 mg filmom obložene tablete Narančasto-bijele, ovalne, bikonveksne filmom obložene tablete, s oznakom „125“ na jednoj strani.
No dose adjustment is required in patients with renal impairment.
Prilagodba doze nije potrebna kod bolesnika s blagim oštećenjem funkcije jetre
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 • Moderate to severe hepatic impairment, i.e., Child-Pugh class B or C (see section 5.2)
• Umjereno do teško oštećenje funkcije jetre, tj. Child-Pugh stadij B ili C (vidjeti dio 5.2)
Some improvements have also been shown in patients with class II PAH.
Dokazana su neka poboljšanja i u bolesnika s II. stupnjem plućne arterijske hipertenzije.
Each tablet contains 62.5 mg of bosentan (as monohydrate).
Jedna tableta sadrži 62,5 mg bosentana (u obliku bosentan hidrata).
Cartons contain 56 or 112 film coated tablets (STAYVEER 125 mg film-coated tablets).
Kutije sadrže 56 ili 112 filmom obloženih tableta (STAYVEER 125 mg filmom obloženih tableta).
Each film-coated tablet contains 62.5 mg bosentan (as monohydrate)
Jedna filmom obložena tableta sadrži 62,5 mg bosentana (u obliku bosentan hidrata)
The impact of moderately impaired liver function (Child-Pugh class B) on the pharmacokinetics of bosentan and its primary metabolite Ro 48-5033 was investigated in a study including 5 patients with pulmonary hypertension associated with portal hypertension and Child-Pugh class B hepatic impairment, and 3 patients with PAH from other causes and normal liver function.
Ro 48-5033 istraženo je u ispitivanju koje je uključivalo 5 bolesnika s plućnom hipertenzijom povezanom s portalnom hipertenzijom i jetrena oštećenja Child-Pugh stadija
Each film-coated tablet contains 125 mg bosentan (as monohydrate)
Jedna filmom obložena tableta sadrži 125 mg bosentana (u obliku bosentan hidrata)
Headache3
Glavobolja3
No dose proportionality was observed, as steady-state bosentan plasma concentrations and AUCs were similar at oral doses of 2 and 4 mg/kg (AUCτ: 3,577 ng·h/mL and 3,371 ng·h/mL for 2 mg/kg twice daily and 4 mg/kg twice daily, respectively).
(AUCτ: 3577 ng•h/mL za 2 mg/kg dvaput dnevno i 3371 ng•h/mL za 4 mg/kg dvaput dnevno).
This difference in infection frequency may in part be due to the longer median treatment exposure in the paediatric set (median 71.8 weeks) compared with the adult set (median 17.4 weeks).
(medijan 71,8 tjedana) u usporedbi s odraslom populacijom (medijan 17,4 tjedna).
Cartons contain 56 film-coated tablets (STAYVEER 125 mg film-coated tablets).
Kutije sadrže 56 filmom obloženih tableta (STAYVEER 125 mg filmom obložene tablete).
After oral administration, the systemic exposure is proportional to dose up to 500 mg. At higher oral doses, Cmax and AUC increase less than proportionally to the dose.
Nakon oralne primjene sistemska izloženost je proporcionalna sve do doze od 500 mg.
STAYVEER 62.5 mg film-coated tablets Orange-white, round, biconvex, film-coated tablets, embossed with “62,5” on one side.
STAYVEER 62,5 mg filmom obložene tablete Narančasto-bijele, okrugle, bikonveksne filmom obložene tablete, s oznakom „62,5“ na jednoj strani.
STAYVEER 125 mg film-coated tablets are orange-white, oval film-coated tablets with “125” on one side.
STAYVEER 125 mg filmom obložene tablete su narančasto-bijele, ovalne filmom obložene tablete s oznakom „125“ na jednoj strani.
STAYVEER 62.5 mg film-coated tablets are orange-white, round film-coated tablets with “62,5” on one side.
STAYVEER 62,5 mg filmom obložene tablete su narančasto-bijele, okrugle filmom obložene tablete s oznakom „62,5“ na jednoj strani.
Cartons contain 56 or 112 film coated tablets (STAYVEER 62.5 mg film-coated tablets).
Kutije sadrže 56 ili 112 filmom obloženih tableta (STAYVEER 62,5 mg filmom obloženih tableta).