FrancophonIA/ELRC3.0 huggingface dataset:
English: Lopinavir/Ritonavir Mylan 200 mg/50 mg film-coated tablets.
Croatian: Lopinavir/Ritonavir Mylan 200 mg/50 mg filmom obložene tablete.
English: Lopinavir/Ritonavir Mylan 100 mg/25 mg film-coated tablets.
Croatian: Lopinavir/Ritonavir Mylan 100 mg/25 mg filmom obložene tablete.
English: What Lopinavir/Ritonavir Mylan looks like and contents of the pack Lopinavir/Ritonavir Mylan 200 mg/50 mg film-coated tablets are white, film coated, ovaloid, biconvex beveled edge tablets debossed with 'MLR3' on one side of the tablet and plain on the other side.
Croatian: Kako Lopinavir/Ritonavir Mylan izgleda i sadržaj pakiranja Lopinavir/Ritonavir Mylan 200 mg/50 mg filmom obložene tablete bijele su, filmom obložene, ovalne, bikonveksne tablete s ukošenim rubom i utisnutom oznakom “MLR3” na jednoj strani tablete i bez ikakve oznake na drugoj strani.
English: Hypromellose Titanium dioxide (E171) Macrogol
Croatian: Film ovojnica: hipromeloza titanijev dioksid (E171) makrogol hidroksipropilceluloza talk silicijev dioksid, koloidni bezvodni polisorbat 80
English: Anxiety Uncommon Abnormal dreams, libido decreased
Croatian: Neuobičajeni snovi, smanjeni libido Poremećaji živčanog sustava Često
English: Lopinavir/Ritonavir Mylan 100 mg/25 mg film-coated tablets OPA/Al/PVC-aluminium blister pack.
Croatian: Lopinavir/Ritonavir Mylan 100 mg/25 mg filmom obložene tablete Blister (OPA/Al/PVC-aluminij).
English: Mean baseline CD4+ T-cell count was 838 cells/mm3 and mean baseline plasma HIV-1 RNA was 4.7 log10 copies/ml.
Croatian: Srednja početna vrijednost broja CD4+ T-stanica limfocita iznosila je na početku terapije 838 stanica/ mm3, a srednja početna vrijednost broja kopija HIV-1 RNA iznosila je 4,7 log10 kopija/ml.
English: Lopinavir/Ritonavir Mylan 200 mg/50 mg film-coated tablets OPA/Al/PVC-aluminium blister pack.
Croatian: Lopinavir/Ritonavir Mylan 200 mg/50 mg filmom obložene tablete Blister (OPA/Al/PVC-aluminij).
English: Each film-coated tablet contains 100 mg of lopinavir co-formulated with 25 mg ritonavir as a pharmacokinetic enhancer.
Croatian: Svaka filmom obložena tableta sadrži 100 mg lopinavira u kombinaciji s 25 mg ritonavira kao farmakokinetičkog pojačivača.
English: Thereby, increasing the risk of serious haematologic abnormalities, or other serious adverse effects from this agent (see section 4.5).
Croatian: Time je povišen rizik od ozbiljnih hematoloških poremećaja i ostalih ozbiljnih nuspojava uzrokovanih ovim tvarima (vidjeti dio 4.5).
English: - Multipacks containing 120, 120x1 (4 cartons of 30 or 30x1) or 360 (12 cartons of 30) film-coated tablets.
Croatian: Dostupne veličine pakiranja: - Višestruka pakiranja koja sadrže 120 x 120 x 1 (4 kutije s 30 ili 30 x 1) ili 360 (12 kutija s 30) filmom obloženih tableta.
English: Lopinavir/Ritonavir Mylan 200 mg/50 mg film-coated tablets Approx 18.8 mm x 10.0 mm, white, film coated, ovaloid, biconvex beveled edge tablet debossed with 'MLR3' on one side of the tablet and plain on the other side.
Croatian: Lopinavir/Ritonavir Mylan 200 mg/50 mg filmom obložene tablete Bijela, ovalna, bikonveksna filmom obložena tableta veličine približno 18,8 mm x 10,0 mm s ukošenim rubom i utisnutom oznakom “MLR3” na jednoj strani tablete i bez ikakve oznake na drugoj strani.
English: The concomitant administration with alfuzosin is contraindicated (see section 4.5).
Croatian: Istodobna primjena s aluzosinom je kontraindicirana (vidjeti dio 4.5).
English: Each film-coated tablet contains 200 mg of lopinavir co-formulated with 50 mg ritonavir as a pharmacokinetic enhancer.
Croatian: Svaka filmom obložena tableta sadrži 200 mg lopinavira u kombinaciji s 50 mg ritonavira kao farmakokinetičkog pojačivača.
English: Buproprion and its active metabolite, hydroxybupropion:
Croatian: Buproprion i njegov aktivni i metabolit hidroksibupropion: AUC and Cmax ↓ ~50%
English: Concomitant administration of elbasvir/grazoprevir with Lopinavir/Ritonavir Mylan is contraindicated (see section 4.3).
Croatian: Istodobna primjena elbasvira/grazoprevira s lijekom Lopinavir/Ritonavir Mylan je kontraindicirana (vidjeti dio 4.3).
English: The concomitant administration of Lopinavir/Ritonavir Mylan and ranolazine is contraindicated (see section 4.3).
Croatian: Istodobna primjena lijeka Lopinavir/Ritonavir Mylan i ranolazina je kontraindicirana (vidjeti dio 4.3).
English: Bedaquiline: AUC: ↑ 22% Cmax: ↔
Croatian: AUC: ↑ 22% Cmax: ↔
English: - Multipacks containing 60 or 60x1 (2 cartons of 30 or 30x1) film-coated tablets.
Croatian: Dostupne veličine pakiranja: - Višestruka pakiranja koja sadrže 60 ili 60 x 1 (2 kutije s 30 ili 30 x 1) filmom obloženih tableta.
English: Concomitant administration of Lopinavir/Ritonavir Mylan and pimozide is contraindicated as it may increase the risk of serious haematologic abnormalities or other serious adverse effects from this agent (see section 4.3)
Croatian: Istodobna primjena lijeka Lopinavir/Ritonavir Mylan i pimozida i terfenadina kontraindicirana je jer može povećati rizik od teških hematoloških promjena ili drugih ozbiljnih nuspojava uzrokovanih tom tvari (vidjeti dio 4.3).
English: Lopinavir/Ritonavir Mylan 100 mg/25 mg film-coated tablets Approx 15.0 mm x 8.0 mm, white, film coated, ovaloid, biconvex beveled edge tablet debossed with 'MLR4' on one side of the tablet and plain on the other side.
Croatian: Lopinavir/Ritonavir Mylan 100 mg/25 mg filmom obložene tablete Bijela, ovalna, bikonveksna filmom obložena tableta veličine približno 15,0 mm x 8,0 mm s ukošenim rubom i utisnutom oznakom “MLR4” na jednoj strani tablete i bez ikakve oznake na drugoj strani.
English: Corticosteroids
Croatian: Kortikosteroidi Deksametazon
English: Cmax:↑ 3.5-fold
Croatian: Cmax: ↑ 3,5 puta
English: Lopinavir/ritonavir is also supplied as 100 mg/25 mg film-coated tablets.
Croatian: Lopinavir/ritonavir je također dostupan u obliku 100 mg/25 mg filmom obloženih tableta.
English: Concentrations are decreased due to CYP3A induction by phenytoin.
Croatian: Koncentracije su smanjene zbog indukcijskog učinka fenitoina na CYP3A.
English: Concentrations may be decreased due to CYP3A induction by dexamethasone.
Croatian: Koncentracije mogu biti smanjene zbog indukcijskog učinka deksametazona na CYP3A.
English: Very common: may affect more than 1 in 10 people.
Croatian: Vrlo česte: mogu se javiti u više od 1 na 10 osoba proljev; mučnina; infekcija gornjeg dišnog sustava.
English: Rationale
Croatian: Objašnjenje
English: The coadministration of vorapaxar with Lopinavir/Ritonavir Mylan is not recommended (see section 4.4 and refer to the vorapaxar SmPC).
Croatian: Istodobna primjena vorapaksara i lijeka Lopinavir/Ritonavir Mylan se ne preporučuje (vidjeti dio 4.4 i Sažetak opisa svojstava lijeka za vorapaksar).
English: Caution should be exercised in administering ceritinib with Lopinavir/Ritonavir Mylan.
Croatian: Potreban je oprez kada se ceritinib primjenjuje zajedno s lijekom Lopinavir/Ritonavir Mylan.
English: More frequent electrocardiogram monitoring and monitoring of transaminases is recommended (see section 4.4 and refer to the bedaquiline SmPC).
Croatian: elektrokardiograma i transaminaza (vidjeti dio 4.4 te Sažetak opisa svojstava lijeka za bedakilin).
English: Concomitant administration of Lopinavir/Ritonavir Mylan and astemizole and terfenadine is contraindicated as it may increase the risk of serious arrhythmias from these agents (see section 4.3).
Croatian: Istodobna primjena lijeka Lopinavir/Ritonavir Mylan i astemizola i terfenadina kontraindicirana je jer može povećati rizik od ozbiljnih aritmija uzrokovanih tim tvarima (vidjeti dio
English: A dose adjustment of Lopinavir/Ritonavir Mylan 400 mg/400 mg (i.e.
Croatian: Prilagođavanjem doze lijeka Lopinavir/Ritonavir Mylan na 400 mg/400 mg (tj.
English: Lopinavir/ritonavir tablets must be swallowed whole and not chewed, broken or crushed.
Croatian: Lopinavir/ritonavir tablete trebalo bi progutati u jednom komadu, bez žvakanja, lomljenja ili usitnjavanja.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE (LABEL)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU BOCA (NALJEPNICA)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON OF BLISTER MULTIPACK (WITHOUT BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA VIŠESTRUKOG PAKIRANJA BLISTERA (BEZ PLAVOGA OKVIRA)
English: Gastrointestinal disorders
Croatian: Lijekovi za gastrointestinalnu pokretljivost
English: The steady state pharmacokinetic parameters of lopinavir in HIV-infected patients with mild to moderate hepatic impairment were compared with those of HIV-infected patients with normal hepatic function in a multiple dose study with lopinavir/ritonavir 400/100 mg twice daily.
Croatian: Farmakokinetički pokazatelji lopinavira u stanju dinamičke ravnoteže, u ispitivanju pri višekratnim dozama lopinavira/ritonavira od 400/100 mg dvaput na dan u bolesnika zaraženih HIV-om, s blagim do umjerenim oštećenjem funkcije jetre uspoređeni su s onim u bolesnika zaraženih HIV-om u kojih je funkcija jetre bila uredna.
English: The dose of Lopinavir/Ritonavir Mylan may need adjusting.
Croatian: Možda će trebati prilagoditi dozu lijeka Lopinavir/Ritonavir Mylan.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON OF BOTTLE MULTIPACK (WITHOUT BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA VIŠESTRUKOG PAKIRANJA BOCE (BEZ PLAVOGA OKVIRA)
English: NAME OF THE MEDICINAL PRODUCT Lopinavir/Ritonavir Mylan 100 mg/25 mg film-coated tablets lopinavir/ritonavir
Croatian: Lopinavir/Ritonavir Mylan 100 mg/25 mg filmom obložene tablete lopinavir/ritonavir
English: Cpredose μg /mL
Croatian: Cmax Cprije početka lječenja μg /mL
English: Coadministration of Lopinavir/Ritonavir Mylan with tadalafil is not recommended.
Croatian: Istodobna primjena lijeka Lopinavir/Ritonavir Mylan i tadalafila nije preporučena.
English: NAME OF THE MEDICINAL PRODUCT Lopinavir/Ritonavir Mylan 200 mg/50 mg film-coated tablets lopinavir/ritonavir
Croatian: Lopinavir/Ritonavir Mylan 200 mg/50 mg filmom obložene tablete lopinavir/ritonavir
English: Fosamprenavir (1400 mg BID) (Lopinavir/ritonavir 533/133 mg BID)
Croatian: (Lopinavir/ritonavir 533/133 mg BID)
English: 400/100 mg BID)
Croatian: Fosamprenavir (1400 mg BID)
English: Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of lurasidone are expected to increase.
Croatian: Zbog inhibicije CYP3A lopinavirom/ritonavirom, očekuje se povećanje koncentracija lurasidona.
English: Lopinavir/ritonavir is an antiretroviral medicine.
Croatian: Stoga lopinavir/ritonavir djeluje antivirusno zahvaljujući lopinaviru.
English: Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of ranolazine are expected to increase.
Croatian: Zbog inhibicije CYP3A lopinavirom/ritonavirom, očekuje se povećanje koncentracija ranolazina.
English: Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of pimozide are expected to increase.
Croatian: Zbog inhibicije CYP3A lopinavirom/ritonavirom očekuje se povećanje koncentracije pimozida.
English: It is not recommended to coadminister Lopinavir/Ritonavir Mylan and telaprevir.
Croatian: Ne preporučuje se istodobna primjena lijeka Lopinavir/Ritonavir Mylan i telaprevira.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1067/008
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/15/1067/008
English: All patients converted to open-label lopinavir/ritonavir at the 400/100 mg twice daily dose between week 48 and week 72.
Croatian: Između 48. i 72. tjedna svi bolesnici prešli su na lopinavir/ritonavir 400/100 mg dva puta dnevno.
English: Cases of pancreatitis have been reported in patients receiving lopinavir/ritonavir, including those who developed hypertriglyceridaemia.
Croatian: Kod bolesnika liječenih lopinavirom/ritonavirom, uključujući i one koji su oboljeli od hipertrigliceridemije, zabilježena je pojava pankreatitisa.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF BLISTER MULTIPACK (WITH BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA VIŠESTRUKOG PAKIRANJA BLISTERA (S PLAVIM OKVIROM)
English: The use of avanafil with Lopinavir/Ritonavir Mylan is contraindicated (see section 4.3).
Croatian: Primjena avanafila s lijekom Lopinavir/Ritonavir Mylan je kontraindicirana (vidjeti dio 4.3).
English: − medicines used to treat pulmonary arterial hypertension (high blood pressure in the pulmonary artery)
Croatian: Za liječenje plućne arterijske hipertenzije:
English: The Lopinavir/Ritonavir Mylan tablets dosage should be increased to 500/125 mg twice daily when coadministered with nevirapine.
Croatian: Kada se daje istodobno s nevirapinom, dozu lijeka Lopinavir/Ritonavir Mylan u tabletama mora se povećati na 500/125 mg dvaput na dan.
English: GI motility agent Cisapride
Croatian: Lijekovi za gastrointestinalnu pokretljivost Cisaprid
English: Lopinavir/ritonavir is also supplied as 200 mg/50 mg film-coated tablets.
Croatian: Lopinavir/ritonavir je dostupan i u obliku 200 mg/50 mg filmom obloženih tableta.
English: Co-administration of lopinavir/ritonavir with rifampicin is not recommended.
Croatian: Ne preporučuje se istovremeno davanje lopinavira/ritonavira s rifampicinom.
English: Patients without prior antiretroviral therapy
Croatian: Bolesnici koji nisu primali antiretrovirusnu terapiju (N = 44)
English: − fusidic acid (used to treat skin infections caused by Staphylococcus bacteria such as impetigo and infected dermatitis.
Croatian: amiodaron, dronedaron (lijekovi za liječenje nepravilnih srčanih otkucaja); lovastatin, simvastatin (lijek za snižavanje kolesterola u krvi); alfuzosin (lijek za liječenje simptoma povećane prostate kod muškaraca (benigna hiperplazija prostate, BHP)); fusidatnu kiselinu (za liječenje kožnih infekcija uzrokovanih bakterijom roda Staphylococcus kao što su impetigo i infektivni dermatitis.
English: Oral Midazolam:
Croatian: Parenteralni midazolam:
English: Vascular disorders
Croatian: Vazodilatatori
English: Adverse events of nausea, dizziness, hypotension and syncope were observed following co-administration of trazodone and ritonavir.
Croatian: Pri istodobnoj primjeni trazodona i ritonavira zamijećene su sljedeće nuspojave: mučnina, omaglica, hipotenzija i sinkopa.
English: 120 Film-coated tablets
Croatian: OBLIK I SADRŽAJ Filmom obložena tableta 120 filmom obloženih tableta
English: It is not recommended to coadminister Lopinavir/Ritonavir Mylan and simeprevir.
Croatian: Ne preporučuje se istodobna primjena lijeka Lopinavir/Ritonavir Mylan i simeprevira.
English: Sorbitan laurate Silica, colloidal anhydrous Copovidone
Croatian: Sadržaj tablete: sorbitanlaurat silicijev dioksid, koloidni, bezvodni kopovidon natrijev stearilfumarat
English: Fosamprenavir/ ritonavir (700/100 mg BID) (Lopinavir/ritonavir
Croatian: Fosamprenavir/ ritonavir (700/100 mg
English: Tel: +385 1 23 50 599
Croatian: Mylan EPD d.o.o. Tel: +385 1 23 50 599
English: MARKETING AUTHORISATION NUMBER EU/1/15/1067/007
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1067/007
English: − vomiting, enlarged abdomen, pain in the lower and upper stomach area, passing wind, indigestion,
Croatian: Česte: mogu se javiti u do 1 na 10 osoba upala gušterače; povraćanje, povećanje trbuha, bol u donjem i gornjem području trbuha, vjetrovi, probavne tegobe, smanjen apetit, povrat sadržaja iz želuca u jednjak što može uzrokovati bol;
English: Lopinavir/Ritonavir Mylan must not be administered once daily in combination with nevirapine.
Croatian: U kombinaciji s nevirapinom Lopinavir/Ritonavir Mylan se ne smije davati jednom dnevno.
English: Voriconazole: Concentrations may be decreased.
Croatian: Njegove koncentracije mogu biti smanjene.
English: The Lopinavir/Ritonavir Mylan tablets dosage should be increased to 500/125 mg twice daily when coadministered with efavirenz.
Croatian: Kada se daje istodobno s efavirenzom, dozu lijeka Lopinavir/Ritonavir Mylan u tabletama mora se povećati na 500/125 mg dvaput na dan.
English: The use of vardenafil with Lopinavir/Ritonavir Mylan is contraindicated (see section 4.3).
Croatian: Istodobna primjena vardenafila i lijeka Lopinavir/Ritonavir Mylan je kontraindicirana (vidjeti dio 4.3).
English: Saquinavir: ↔
Croatian: Sakvinavir: ↔
English: Lopinavir/Ritonavir Mylan 100 mg/25 mg film-coated tablets are white, film coated, ovaloid, biconvex beveled edge tablets debossed with 'MLR4' on one side of the tablet and plain on the other side.
Croatian: Kako Lopinavir/Ritonavir Mylan izgleda i sadržaj pakiranja Lopinavir/Ritonavir Mylan 100 mg/25 mg filmom obložene tablete bijele su, filmom obložene, ovalne, bikonveksne tablete s ukošenim rubom i utisnutom oznakom “MLR4” na jednoj strani tablete i bez ikakve oznake na drugoj strani.
English: Lopinavir: AUC: ↔ Cmin: ↓ 20% Cmax: ↔
Croatian: Cmin: ↓ 20% Cmax: ↔
English: Renal and urinary disorders
Croatian: Lamotrigin i Valproat
English: Serum concentrations may be increased due to CYP3A inhibition by lopinavir/ritonavir.
Croatian: Koncentracije u serumu mogu se povećati zbog inhibicije CYP3A lopinavirom/ritonavirom.
English: Serum concentrations may be increased due to CYP3A and P-gp inhibition by lopinavir/ritonavir
Croatian: Serumske koncentracije mogu biti povišene zbog inhibicijskog učinka lijeka lopinavira/ritonavira na CYP3A i P-gp.
English: Lopinavir/Ritonavir Mylan must not be administered once daily in combination with efavirenz.
Croatian: U kombinaciji s efavirenzom Lopinavir/Ritonavir Mylan se ne smije davati jednom dnevno.
English: Clinical monitoring of therapeutic and adverse effects is recommended when these medicines are concomitantly administered with Lopinavir/Ritonavir Mylan.
Croatian: Koncentracije karbamazepina i fenobarbitala moraju se pratiti pri njihovoj istodobnoj primjeni s lijekom Lopinavir/Ritonavir Mylan.
English: Phenytoin levels should be monitored when co-administering with Lopinavir/Ritonavir Mylan.
Croatian: Razine fenitoina moraju se pratiti pri njegovoj istodobnoj primjeni s lijekom Lopinavir/Ritonavir Mylan.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1067/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/15/1067/001
English: Cmin: ↑ 3.5-fold
Croatian: Cmin: ↑ 3,5 puta
English: Due to CYP3A4 inhibition by lopinavir/ritonavir.
Croatian: Zbog inhibicijskog učinka lopinavira/ritonavira na CYP3A4.
English: Lopinavir/Ritonavir Mylan must not be administered once daily in combination with phenytoin.
Croatian: U kombinaciji s fenitoinom Lopinavir/Ritonavir Mylan se ne smije davati jednom dnevno.
English: Lopinavir/Ritonavir Mylan must not be administered once daily in combination with amprenavir.
Croatian: U kombinaciji s amprenavirom lijek Lopinavir/Ritonavir Mylan se ne smije davati jednom dnevno.
English: − night sweats, itching, rash including raised bumps on the skin, infection of the skin, inflammation of skin or hair pores, accumulation of fluid in the cells or tissues.
Croatian: hemoroidi; upala jetre uključujući povišenje jetrenih enzima; alergijske reakcije uključujući koprivnjaču i upale u ustima; infekcije donjih dišnih puteva; povećanje limfnih čvorova; impotencija, preobilno ili produženo menstrualno krvarenje ili izostanak menstruacije; poremećaj mišića kao što su slabosti i grčevi, bol u zglobovima, mišićima i leđima; oštećenje živaca perifernog živčanog sustava; noćno znojenje, svrbež, osip uključujući ispupčenja na koži, kožne infekcije, upalu kože ili pora dlačica, nakupljanje tekućine u stanicama ili tkivima.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1067/004
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/15/1067/004
English: Serum concentrations may be increased due to CYP3A inhibition by lopinavir/ritonavir
Croatian: Serumske koncentracije mogu biti povećane zbog inhibicijskog učinka lopinavira/ritonavira na CYP3A.
English: AUC: ↑ 5-fold
Croatian: AUC: ↑ 4 puta
English: Fluvastatin or Pravastatin Fluvastatin, Pravastatin: No clinical relevant interaction expected.
Croatian: Ne očekuje se klinički značajna interakcija.
English: Caution is warranted and therapeutic drug monitoring of digoxin concentrations, if available, is recommended in case of coadministration of Lopinavir/Ritonavir Mylan and digoxin.
Croatian: Pri istodobnoj primjeni lijeka Lopinavir/Ritonavir Mylan i digoksina nužan je oprez, a preporučuje se i terapijsko praćenje koncentracije digoksina, ukoliko je
English: These belong to a group of medicines called bronchodilators.
Croatian: One pripadaju skupini lijekova koje nazivamo bronhodilatatorima.
English: Children and adolescents Do not give this medicine to children or adolescents below the age of 18 years.
Croatian: Nemojte primjenjivati ovaj lijek djeci i adolescenatima mlađim od 18 godina.
English: n/e
Croatian: n/o
English: Barnard Castle, County Durham DL12 8DT United Kingdom
Croatian: Barnard Castle, County Durham DL12 8DT Ujedinjeno Kraljevstvo
English: Other antimuscarinics and sympathomimetics
Croatian: Ostali antimuskarinici i simpatomimetici
English: • pain and irritation in the back of the mouth and throat
Croatian: • bol i nadraženost u stražnjem dijelu usta i grlu
English: For pharmacokinetic purposes each component can therefore be considered separately.
Croatian: Stoga se za potrebe farmakokinetike svaki sastojak može razmotriti zasebno.
English: Concurrent use of either non-selective or selective beta-adrenergic blockers should be avoided unless there are compelling reasons for their use.
Croatian: Istodobnu primjenu neselektivnih ili selektivnih beta-adrenergičkih blokatora treba izbjegavati, osim ako ne postoje opravdani razlozi za njihovu primjenu.
English: Date of first authorisation: 08 May 2014 Date of latest renewal: 15 January 2019
Croatian: Datum posljednje obnove odobrenja: 15. siječnja 2019.
English: Characteristics in specific groups of healthy volunteers or patients
Croatian: Značajke u posebnim skupinama zdravih dobrovoljaca ili bolesnika Starije osobe
English: The following statements reflect studies conducted on the individual components.
Croatian: Sljedeće tvrdnje odraz su ispitivanja provedenih s pojedinačnim sastavnicama.
English: - if you are allergic to umeclidinium, vilanterol or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na umeklidinij, vilanterol ili neki drugi sastojak ovoga lijeka (naveden u dijelu 6.).
English: COPD is a long-term condition characterised by breathing difficulties that slowly get worse.
Croatian: KOPB je dugotrajna bolest koju karakteriziraju tegobe s disanjem koje se polako pogoršavaju.
English: • suddenly feeling weak or light headed (which may lead to collapse or loss of consciousness)
Croatian: • iznenadan osjećaj slabosti ili ošamućenosti (koji može dovesti do kolapsa ili gubitka svijesti)
English: Vilanterol was not teratogenic in rats.
Croatian: Vilanterol nije bio teratogen u štakora.
English: No dose adjustment is required in patients over 65 years.
Croatian: Nije potrebno prilagođavati dozu u bolesnika starijih od 65 godina.
English: Umeclidinium/vilanterol should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the foetus.
Croatian: Umeklidinij/vilanterol se tijekom trudnoće smije primjenjivati samo ako očekivana korist za majku opravdava mogući rizik za plod.
English: If you have any of the following symptoms after taking ANORO ELLIPTA stop using this medicine and tell your doctor immediately.
Croatian: Ako imate bilo koji od sljedećih simptoma nakon uzimanja lijeka ANORO ELLIPTA, prestanite primjenjivati ovaj lijek i odmah se javite svom liječniku.
English: Treatment difference1 (95% confidence intervals, p-value) Trough FEV1 (ml)
Croatian: Terapijska razlika1 (95% intervali pouzdanosti, p-vrijednost) Najniža vrijednost FEV1 (ml)
English: It is very important that you use ANORO ELLIPTA every day, as instructed by your doctor.
Croatian: Vrlo je važno da ANORO ELLIPTA primjenjujete svakoga dana prema uputama liječnika.
English: Improvement in EET compared with placebo was seen at Day 2 and was sustained at Week 6 and Week 12.
Croatian: Poboljšanje EET vrijednosti u usporedbi s placebom primijećeno je 2. dana, a održano je u 6. tjednu i u 12. tjednu.