natgillin/translations-raw huggingface dataset:
Multipack: 196 (7 packs of 28) film-coated tablets 
Filmom obložena tableta Višestruko pakiranje: 196 (7 pakiranja od 28) filmom obloženih tableta
No clinically relevant drug-drug interaction was observed when simvastatin and Neparvis were coadministered. 
Nije primjećena klinički značajna interakcija među lijekovima prilikom istodobne primjene simvastatina i Neparvisa.
In a 21-day study in HFrEF patients, Neparvis significantly increased urine ANP and cGMP and plasma cGMP, and decreased plasma NT-proBNP, aldosterone and endothelin-1 compared to baseline. 
U 21-dnevnom ispitivanju u bolesnika s HFrEF-om, Neparvis je značajno povećao ANP i cGMP u mokraći te cGMP u plazmi, a smanjio NT-proBNP, aldosteron i endotelin-1 u plazmi u usporedbi s početnim vrijednostima.
In patients with mild to moderate hepatic impairment, the exposures of sacubitril increased by 1.5- and 3.4- fold, LBQ657 increased by 1.5- and 1.9-fold, and valsartan increased by 1.2-fold and 2.1-fold, respectively, compared to matching healthy subjects. 
U bolesnika s blagim do umjerenim oštećenjem jetre, izloženosti sakubitrilu povećale su se za 1,5, odnosno 3,4 puta, LBQ657 za 1,5, odnosno 1,9 puta, a valsartanu za 1,2, odnosno 2,1 puta, u usporedbi s odgovarajućim zdravim ispitanicima.
A slight increase in two foetal skeletal variations (misshapen sternebra, sternebra bipartite ossification) was observed in rabbits at an Neparvis dose of 4.9 mg sacubitril/5.1 mg valsartan/kg/day. 
Blago povećanje dviju varijacija fetusnog skeleta (deformirana sternebra, dvostrana osifikacija sternebre) bilo je uočeno u zečeva pri dozi Neparvisa od 4,9 mg sakubitrila/5,1 mg valsartana/kg/dan.
If any of the above applies to you, tell your doctor, pharmacist or nurse before you take Neparvis. 
Ako se bilo što od navedenoga odnosi na Vas, obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije uzimanja Neparvisa.
• spinning sensation 
• osjećaj vrtnje
• Severe hepatic impairment, biliary cirrhosis and cholestasis (see section 4.2). 
• Teško oštećenje jetre, bilijarna ciroza i kolestaza (vidjeti dio 4.2).
Neparvis 97 mg/103 mg film-coated tablets 
Neparvis 97 mg/103 mg filmom obložene tablete
The MAH must ensure that the manufacturing processes of the drug substances used for their drug products are reviewed for the potential risk of formation of N-nitrosamines and changed as necessary to minimise nitrosamine contamination as much as possible. 
Nnitrozamina te da se prema potrebi promijene kako bi se kontaminacija nitrozaminom svela na najmanju moguću mjeru.
• if you have severe liver disease. 
• ako imate tešku bolest jetre
Iron oxide yellow (E172) 
Željezov oksid, crveni (E172) Željezov oksid, žuti (E172)
Iron oxide black (E172) 
Željezov oksid, crveni (E172) Željezov oksid, crni (E172)
Neparvis 24 mg/26 mg film-coated tablets 
Neparvis 24 mg/26 mg filmom obložene tablete
Neparvis has not been studied in patients with severe hepatic impairment, biliary cirrhosis or cholestasis (see sections 4.3 and 4.4). 
Neparvis nije bio ispitivan u bolesnika s teškim oštećenjem jetre, bilijarnom cirozom ili kolestazom (vidjeti dijelove 4.3 i 4.4).
If you have been taking an ACE inhibitor, wait for 36 hours after taking the last dose before you start to take Neparvis (see “Other medicines and Neparvis”). 
Ako uzimate ACE inhibitor, pričekajte 36 sati nakon uzimanja posljednje doze prije nego počnete uzimati Neparvis (vidjeti „Drugi lijekovi i Neparvis“).
Treatment should not be initiated if the serum potassium level is >5.4 mmol/l. 
Liječenje se ne smije započeti u bolesnika s razinom kalija u serumu >5,4 mmol/l.
20 film-coated tablets 
20 filmom obloženih tableta
Neparvis 49 mg/51 mg film-coated tablets are pale yellow oval tablets with “NVR” on one side and “L1” on the other side. 
Neparvis 49 mg/51 mg filmom obložene tablete su blijedo žute ovalne tablete s oznakom „NVR“ s jedne strane i „L1“ s druge strane.
In the PARADIGM-HF study, Neparvis decreased plasma NT-proBNP and increased plasma BNP and urine cGMP compared with enalapril. 
U ispitivanju PARADIGM-HF, Neparvis je smanjio NT-proBNP u plazmi i povećao BNP u plazmi i cGMP u mokraći u usporedbi s enalaprilom.
• The 49 mg/51 mg tablet coating contains hypromellose, titanium dioxide (E171), Macrogol 4000, talc, iron oxide red (E172) and iron oxide yellow (E172). 
• Ovojnica tablete od 49 mg/51 mg sadrži hipromelozu, titanijev dioksid (E171), makrogol 4000, talk, željezov oksid crveni (E172) i željezov oksid žuti (E172).
Neparvis 49 mg/51 mg film-coated tablets 
Neparvis 49 mg/51 mg filmom obložene tablete
≥49 mg sacubitril/51 mg valsartan/kg/day (≤0.72-fold the maximum recommended human dose [MRHD] on the basis of AUC) and rabbits at doses ≥4.9 mg sacubitril/5.1 mg valsartan/kg/day (2-fold and 0.03-fold the MRHD on the basis of valsartan and LBQ657 AUC, respectively). 
Liječenje Neparvisom tijekom organogeneze rezultiralo je povećanom embriofetalnom smrtnosti u štakora pri dozama ≥49 mg sakubitrila/51 mg valsartana/kg/dan (≤0,72 puta najveće preporučene doze za ljude [MRHD] na temelju AUC-a) i u zečeva pri dozama ≥4,9 mg sakubitrila/5,1 mg valsartana/kg/dan (2 odnosno 0,03 puta MRHD-a na temelju AUC-a valsartana, odnosno LBQ657).
At the time of Commission Decision 
Odluke Komisije
Neparvis should not be co-administered with an ACE inhibitor or an ARB. Due to the potential risk of angioedema when used concomitantly with an ACE inhibitor, it must not be started for at least 36 hours after discontinuing ACE inhibitor therapy (see sections 4.3, 4.4 and 4.5). 
Zbog potencijalnog rizika od angioedema kada se primjenjuje istodobno s ACE inhibitorom, on se ne smije uvesti u terapiju najmanje 36 sati nakon prekida terapije ACE inhibitorom (vidjeti dijelove 4.3, 4.4 i 4.5).
Hypokalaemia 
Hipokalijemija
• The 24 mg/26 mg and the 97 mg/103 mg tablet coatings contain hypromellose, titanium dioxide (E171), Macrogol 4000,talc, iron oxide red (E172) and iron oxide black (E172). 
• Ovojnica tableta od 24 mg/26 mg i 97 mg/103 mg sadrži hipromelozu, titanijev dioksid (E171), makrogol 4000, talk, željezov oksid crveni (E172) i željezov oksid crni (E172).
• if your kidney artery has narrowed. 
• ako imate suženu bubrežnu arteriju.
In PARADIGM-HF, renal impairment was reported in 10.1% of Neparvis-treated patients and 11.5% of enalapril-treated patients. 
U ispitivanju PARADIGM-HF, oštećenje bubrega je prijavljeno u 10,1% bolesnika liječenih Neparvisom te u 11,5% bolesnika liječenih enalaprilom.
Candesartan 32 * These limits are not applicable for batches where more than one of the above N-nitrosamines has been identified simultaneously; such batches should be rejected. 
valsartan 320 losartan 150 olmesartan 40 irbesartan 300 kandesartan 32 * Te granične vrijednosti nisu primjenjive za serije gdje je utvrđeno istodobno postojanje više od jednog od prethodno navedenih N-nitrozamina; takve serije treba odbaciti.
• low level of red blood cells (shown in a blood test) 
• niska razina crvenih krvnih stanica (vidljivo iz krvne pretrage)
56 film-coated tablets. 
56 filmom obloženih tableta.
28 film-coated tablets 
28 filmom obloženih tableta
If you have been taking an ACE inhibitor, wait 36 hours after taking the last dose of the ACE inhibitor before starting to take Neparvis (see “Do not take Neparvis”). 
Ako uzimate ACE inhibitor, pričekajte 36 sati nakon uzimanja posljednje doze ACE inhibitora prije nego počnete uzimati Neparvis (vidjeti „Uzimanje drugih lijekova“).
28 film-coated tablets. 
28 filmom obloženih tableta.
No dose adjustment is required in patients with mild (Estimated Glomerular Filtration Rate [eGFR] 60-90 ml/min/1.73 m2) renal impairment. 
Estimated Glomerular Filtration Rate [eGFR] 60-90 ml/min/1,73 m2) oštećenjem bubrega.
• decreased renal function (renal impairment) 
• smanjena bubrežna funkcija (oštećenje bubrega)
1) Limits for NDMA and NDEA outlined below should be implemented for a transitional period of 2 years: 
U prijelaznom razdoblju od dvije godine potrebno je primjenjivati granične vrijednosti za tvari NDMA i NDEA navedene u nastavku:
Very common Orthostatic hypotension Common 
Ortostatska hipotenzija
then to the target dose of 200 mg twice daily, with either a 3-week or a 6-week regimen. 
Neparvisa od 50 mg dvaput na dan te bili titrirani na 100 mg dvaput na dan, zatim na ciljnu dozu od 200 mg dvaput na dan, s režimom doziranja od 3 tjedna ili od 6 tjedana.
Neparvis must not be administered until 36 hours after discontinuing ACE inhibitor therapy. 
Neparvis se ne smije primjenjivati do 36 sati nakon prekida terapije ACE inhibitorom.
≤ eGFR <60 ml/min/1.73 m 2) and severe renal impairment (15 ml/min/1.73 m eGFR <30 ml/min/1.73 m2) was 1.4-fold and 2.2-fold higher compared to patients with mild renal impairment (60 ml/min/1.73 m 
<30 ml/min/1,73 m2) bila je 1,4-puta odnosno 2,2-puta viša u usporedbi s bolesnicima s blagim oštećenjem bubrega (60 ml/min/1,73 m
Therefore, when initiating therapy with Neparvis in patients receiving metformin, the clinical status of the patient should be evaluated. 
Stoga je potrebno ocijeniti klinički status bolesnika kada se započinje terapija Neparvisom u bolesnika koji primaju metformin.
• Concomitant use with aliskiren-containing medicinal products in patients with diabetes mellitus or in patients with renal impairment (eGFR <60 ml/min/1.73 m2) (see sections 4.4 and 4.5). 
• Istodobna primjena s lijekovima koji sadrže aliskiren u bolesnika sa šećernom bolesti ili u bolesnika s oštećenjem bubrega (eGFR <60 ml/min/1,73 m2) (vidjeti dijelove 4.4 i 4.5).
Syncope 
Sinkopa
In a 7-day valsartan-controlled study in patients with reduced ejection fraction (HFrEF), administration of Neparvis resulted in an initial increase in natriuresis, increased urine cGMP, and decreased plasma levels of mid-regional pro-atrial natriuretic peptide (MR-proANP) and N-terminal prohormone brain natriuretic peptide (NT-proBNP) compared to valsartan. 
povećanjem koncentracije cGMP-a u mokraći te smanjenim razinama u plazmi srednje-regionalnog proatrijalnog natriuretskog peptida (MR-proANP) i N-terminalnog prohormona moždanog natriuretskog peptida (NT-proBNP) u usporedbi s valsartanom.
Impaired hepatic function 
Oštećena bubrežna funkcija
• low level of sugar in the blood (shown in a blood test) 
• niska razina šećera u krvi (vidljivo iz krvne pretrage)
Neparvis contains valsartan, and therefore should not be co-administered with another ARB containing product (see section 4.4). 
Interakcije koje rezultiraju time da se ne preporučuje istodobna primjena Neparvis sadrži valsartan pa se stoga ne smije primjenjivati zajedno s drugim lijekom koji sadrži ARB (vidjeti dio 4.4).
Secondary endpoint 
Sekundarni ishod
Other possible side effects: If any of the side effects listed below becomes severe, tell your doctor or pharmacist. 
Ako bilo koja od nuspojava navedenih u nastavku postane teška, obratite se svom liječniku ili ljekarniku.
What Neparvis looks like and contents of the pack Neparvis 24 mg/26 mg film-coated tablets are violet-white oval tablets with “NVR” on one side and “LZ” on the other side. 
Neparvis 24 mg/26 mg filmom obložene tablete su ljubičasto bijele ovalne tablete s oznakom „NVR“ s jedne strane i „LZ“ s druge strane.
56 film-coated tablets 
56 filmom obloženih tableta
Therefore, co-administration of Neparvis with inhibitors of OATP1B1, OATP1B3, OAT3 (e.g. rifampicin, ciclosporin), OAT1 (e.g. tenofovir, 
Stoga istodobna primjena Neparvisa s inhibitorima OATP1B1, OATP1B3, OAT3 (npr. rifampicinom, ciklosporinom), OAT1 (npr. tenofovirom, cidofovirom) ili MRP2 (npr. ritonavirom) može povećati sistemsku izloženost LBQ657 ili valsartanu.
CLINICAL PARTICULARS 
Ostali neklinički nalazi
Worsening renal function 
Pogoršanje bubrežne funkcije
Neparvis must not be started until 36 hours after taking the last dose of ACE inhibitor therapy. 
Neparvis se ne smije započinjati do 36 sati nakon uzimanja zadnje doze terapije ACE inhibitorom.
The exposure of LBQ657 in patients with moderate (30 ml/min/1.73 m 
Izloženost LBQ657 u bolesnika s umjerenim (30 ml/min/1,73 m eGFR <60 ml/min/1,73 m2) i teškim oštećenjem bubrega (15 ml/min/1,73 m
Neparvis must not be initiated until 36 hours after taking the last dose of ACE inhibitor therapy. 
Primjena Neparvisa ne smije se započinjati do 36 sati nakon uzimanja zadnje doze terapije ACE inhibitorom.
Neparvis 49 mg/51 mg film-coated tablets Hypromellose, substitution type 2910 (3 mPa·s) Titanium dioxide (E171) Macrogol 4000 
Neparvis 49 mg/51 mg filmom obložene tablete Hipromeloza, supstitucijski tip 2910 (3 mPa s) Titanijev dioksid (E171) Makrogol 4000
The pharmacokinetics of sacubitril, LBQ657 and valsartan were approximately linear over an Neparvis dose range of 24 mg sacubitril/26 mg valsartan to 97 mg sacubitril/103 mg valsartan. 
Neparvisa od 24 mg sakubitrila/26 mg valsartana do 97 mg sakubitrila/103 mg valsartana.
The concomitant use of Neparvis with aliskiren-containing products is contraindicated in patients with diabetes mellitus or in patients with renal impairment (eGFR <60 ml/min/1.73 m2) (see section 4.3). 
Istodobna primjena Neparvisa i lijekova koji sadrže aliskiren kontraindicirana je u bolesnika sa šećernom bolesti ili u bolesnika s oštećenjem bubrega (eGFR <60 ml/min/1,73 m2) (vidjeti dio 4.3).
The combination of Neparvis with aliskiren-containing products is contraindicated in patients with diabetes mellitus or in patients with renal impairment (eGFR <60 ml/min/1.73 m2) (see sections 4.3 and 4.5). 
Kombinacija Neparvisa s lijekovima koji sadrže aliskiren kontraindicirana je u bolesnika sa šećernom bolesti ili u bolesnika s oštećenjem bubrega (eGFR <60 ml/min/1,73 m (vidjeti dijelove 4.3 i 4.5).
Neparvis 24 mg/26 mg tablets sacubitril/valsartan 
Neparvis 24 mg/26 mg tablete sakubitril/valsartan
Pale yellow ovaloid biconvex film-coated tablet with bevelled edges, unscored, debossed with “NVR” on one side and “L1” on the other side. 
Blijedo žuta ovaloidna bikonveksna filmom obložena tableta s kosim rubovima, bez zareza, s utisnutom oznakom „NVR“ s jedne strane i „L1“ s druge strane.
Pack sizes: 14, 20, 28 or 56 film-coated tablets and multipacks containing 168 (3x56) or 196 (7x28) film-coated tablets. 
Neparvis 49 mg/51 mg filmom obložene tablete Veličine pakiranja: 14, 20, 28 ili 56 filmom obloženih tableta i višestruka pakiranja koja sadrže 168 (3x56) ili 196 (7x28) filmom obloženih tableta.
Neparvis 97 mg/103 mg film-coated tablets Hypromellose, substitution type 2910 (3 mPa·s) Titanium dioxide (E171) Macrogol 4000 
Neparvis 97 mg/103 mg filmom obložene tablete Hipromeloza, supstitucijski tip 2910 (3 mPa s) Titanijev dioksid (E171) Makrogol 4000
Light pink ovaloid biconvex film-coated tablet with bevelled edges, unscored, debossed with “NVR” on one side and “L11” on the other side. 
Svijetlo ružičasta ovaloidna bikonveksna filmom obložena tableta s kosim rubovima, bez zareza, s utisnutom oznakom „NVR“ s jedne strane i „L11“ s druge strane.
Neparvis 49 mg/51 mg tablets sacubitril/valsartan 
Neparvis 49 mg/51 mg tablete sakubitril/valsartan
Neparvis 97 mg/103 mg tablets sacubitril/valsartan 
Neparvis 97 mg/103 mg tablete sakubitril/valsartan
Neparvis 24 mg/26 mg film-coated tablets Hypromellose, substitution type 2910 (3 mPa·s) Titanium dioxide (E171) Macrogol 4000 
Neparvis 24 mg/26 mg filmom obložene tablete Hipromeloza, supstitucijski tip 2910 (3 mPa s) Titanijev dioksid (E171) Makrogol 4000
Violet white ovaloid biconvex film-coated tablet with bevelled edges, unscored, debossed with “NVR” on one side and “LZ” on the other side. 
Ljubičasto bijela ovaloidna bikonveksna filmom obložena tableta s kosim rubovima, bez zareza, s utisnutom oznakom „NVR“ s jedne strane i „LZ“ s druge strane.
Neparvis 24 mg/26 mg film-coated tablets sacubitril/valsartan 
Neparvis 24 mg/26 mg filmom obložene tablete sakubitril/valsartan
Immune system disorders 
Poremećaji imunološkog sustava Preosjetljivost
Neparvis 97 mg/103 mg film-coated tablets sacubitril/valsartan 
Neparvis 97 mg/103 mg filmom obložene tablete sakubitril/valsartan
• high level of potassium in the blood (shown in a blood test) 
• visoka razina kalija u krvi (vidljivo iz krvne pretrage)
Each film-coated tablet contains 48.6 mg sacubitril and 51.4 mg valsartan (as sacubitril valsartan sodium salt complex). 
Svaka filmom obložena tableta sadrži 48,6 mg sakubitrila i 51,4 mg valsartana (u obliku sakubitril valsartan kompleksa natrijeve soli).
Frequency category 
Kategorija učestalosti
Approximate tablet dimensions 13.1 mm x 5.2 mm Neparvis 97 mg/103 mg film-coated tablets are light pink oval tablets with “NVR” on one side and “L11” on the other side. 
Neparvis 97 mg/103 mg filmom obložene tablete su svijetlo ružičaste ovalne tablete s oznakom „NVR“ s jedne strane i „L11“ s druge strane.
Neparvis 49 mg/51 mg film-coated tablets sacubitril/valsartan 
Neparvis 49 mg/51 mg filmom obložene tablete sakubitril/valsartan
There are no available data on the effect of Neparvis on human fertility. 
Neparvisa na ljudsku plodnost.
Posology 
Ovojnica
More patients who were naïve to previous ACE inhibitor or ARB therapy or on low-dose therapy (equivalent to <10 mg enalapril/day) were able to achieve and maintain Neparvis 200 mg when up-titrated over 6 weeks (84.8%) versus 3 weeks (73.6%). 
Neparvisa od 200 mg kada se doza titrirala prema većoj tijekom 6 tjedana (84,8%) u odnosu na 3 tjedna (73,6%).
Pack sizes: 14, 20, 28 or 56 film-coated tablets and multipacks containing 196 (7x28) film-coated tablets. 
Neparvis 24 mg/26 mg filmom obložene tablete Veličine pakiranja: 14, 20, 28 ili 56 filmom obloženih tableta i višestruka pakiranja koja sadrže 196 (7x28) filmom obloženih tableta.
Each film-coated tablet contains 97.2 mg sacubitril and 102.8 mg valsartan (as sacubitril valsartan sodium salt complex). 
Svaka filmom obložena tableta sadrži 97,2 mg sakubitrila i 102,8 mg valsartana (u obliku sakubitril valsartan kompleksa natrijeve soli).
Each film-coated tablet contains 24.3 mg sacubitril and 25.7 mg valsartan (as sacubitril valsartan sodium salt complex). 
Svaka filmom obložena tableta sadrži 24,3 mg sakubitrila i 25,7 mg valsartana (u obliku sakubitril valsartan kompleksa natrijeve soli).
• low level of potassium in the blood (shown in a blood test) 
• niska razina kalija u krvi (vidljivo iz krvne pretrage)
o Each 24 mg/26 mg film-coated tablet contains 24.3 mg sacubitril and 25.7 mg valsartan (as sacubitril valsartan sodium salt complex). 
o Svaka 24 mg/26 mg filmom obložena tableta sadrži 24,3 mg sakubitrila i 25,7 mg valsartana (u obliku sakubitril valsartan kompleksa natrijeve soli).
Patients with renal artery stenosis 
Bolesnici sa stenozom bubrežne arterije
If you stop taking Neparvis, wait 36 hours after taking your last dose of Neparvis before starting an ACE inhibitor. 
Ako prestanete uzimate Neparvis, pričekajte 36 sati nakon uzimanja posljednje doze Neparvisa prije nego počnete uzimati ACE inhibitor (vidjeti „Uzimanje drugih lijekova“).
o Each 49 mg/51 mg film-coated tablet contains 48.6 mg sacubitril and 51.4 mg valsartan (as sacubitril valsartan sodium salt complex). 
o Svaka 49 mg/51 mg filmom obložena tableta sadrži 48,6 mg sakubitrila i 51,4 mg valsartana (u obliku sakubitril valsartan kompleksa natrijeve soli).
Each 24 mg/26 mg tablet contains 24.3 mg sacubitril and 25.7 mg valsartan (as sacubitril valsartan sodium salt complex). 
Svaka tableta od 24 mg/26 mg sadrži 24,3 mg sakubitrila i 25,7 mg valsartana (u obliku sakubitril valsartan kompleksa natrijeve soli).
Vascular disorders 
Magnezijev stearat
• tiredness 
• omaglica
Each 49 mg/51 mg tablet contains 48.6 mg sacubitril and 51.4 mg valsartan (as sacubitril valsartan sodium salt complex). 
Svaka tableta od 49 mg/51 mg sadrži 48,6 mg sakubitrila i 51,4 mg valsartana (u obliku sakubitril valsartan kompleksa natrijeve soli).
o Each 97 mg/103 mg film-coated tablet contains 97.2 mg sacubitril and 102.8 mg valsartan (as sacubitril valsartan sodium salt complex). 
o Svaka 97 mg/103 mg filmom obložena tableta sadrži 97,2 mg sakubitrila i 102,8 mg valsartana (u obliku sakubitril valsartan kompleksa natrijeve soli).
• fainting 
• nesvjestica
Each 97 mg/103 mg tablet contains 97.2 mg sacubitril and 102.8 mg valsartan (as sacubitril valsartan sodium salt complex). 
Svaka tableta od 97 mg/103 mg sadrži 97,2 mg sakubitrila i 102,8 mg valsartana (u obliku sakubitril valsartan kompleksa natrijevih soli).
Cough 
Kalij
Colloidal anhydrous silica 
Silicijev dioksid, koloidni, bezvodni
Nausea 
Vrtoglavica
Dizziness postural 
Prijavljivanje nuspojava
Preferred term 
Krajnji rok
Anaemia 
Astenija
Irbesartan 300 
6.3 Rok valjanosti
ITP in adults 
ITP u odraslih
ITP in children 
ITP u djece
Further information on Revolade can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Revolade. 
Više informacija o lijeku Revolade nalazi se na internetskim stranicama Agencije:ema.europa.eu/medicines/human/EPAR/Revolade.
Revolade is a medicine that is used for the treatment of: 
Revolade je lijek koji se primjenjuje za liječenje:
Revolade received a marketing authorisation valid throughout the EU on 11 March 2010. 
Lijek Revolade dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 11. ožujka 2010.
This overview was last updated in 03-2019. 
Pregled informacija posljednji je put ažuriran u 3. 2019.
What measures are being taken to ensure the safe and effective use of Revolade? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Revolade?
Other information about Revolade 
Ostale informacije o lijeku Revolade
What is Revolade and what is it used for? 
Što je Revolade i za što se primjenjuje?
Severe aplastic anaemia 
Teška aplastična anemija
The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in treating blood diseases or chronic hepatitis C and its complications. 
Lijek se izdaje samo na liječnički recept, a liječenje treba započeti i nadzirati liječnik s iskustvom u liječenju krvnih bolesti ili kroničnog hepatitisa C i njegovih komplikacija.
For ITP and aplastic anaemia, a lower starting dose should be used in patients of Asian descent (such as Chinese, Japanese, Korean or Taiwanese people). 
Za ITP i aplastičnu anemiju može biti potrebna niža početna doza u bolesnika azijskog podrijetla (poput Kineza, Japanaca, Korejaca i Tajvanaca).
Preliminary data from a supportive study are consistent with the result of the main study, with 46% of patients responding to treatment after 12 weeks. 
Preliminarni podatci iz popratnog ispitivanja u skladu su s rezultatima glavnog ispitivanja, pri čemu je 46 % bolesnika reagiralo na liječenje nakon 12 tjedana.
Why is Revolade authorised in the EU? 
Zašto je Revolade odobren u EU-u?
Revolade is available as tablets (12.5, 25, 50 and 75 mg) and as a powder (25 mg) to prepare a suspension (a liquid) to be taken by mouth. 
Revolade je dostupan u obliku tableta (od 12,5; 25; 50 i 75 mg) i praška (25 mg) za pripremu suspenzije (tekućine) koji se uzimaju na usta.
• thrombocytopenia in adults with chronic (long-term) hepatitis C, a liver disease caused by the hepatitis C virus. 
• trombocitopenije u odraslih s kroničnim (dugotrajnim) hepatitisom C, bolešću koju uzrokuje virus hepatitisa C.
Side effects reported with Revolade are carefully evaluated and any necessary action taken to protect patients. 
Nuspojave prijavljene za lijek Revolade pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
For the treatment of thrombocytopenia associated with hepatitis C, two main studies involving a total of 1,441 adults were carried out. 
Za liječenje trombocitopenije povezane s hepatitisom C provedena su dva glavna ispitivanja kojima je bila obuhvaćena ukupno 1 441 odrasla osoba.
For the treatment of severe aplastic anaemia, Revolade was studied in 43 patients and it was not compared with any other medicine. 
Za liječenje teške aplastične anemije Revolade je ispitivan u 43 bolesnika te nije uspoređivan s drugim lijekovima.
As for all medicines, data on the use of Revolade are continuously monitored. 
Kao i za sve lijekove, podatci o primjeni lijeka Revolade kontinuirano se prate.