FrancophonIA/ELRC3.0 huggingface dataset:
English: methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216).
Slovak: (E218), propylparabén (E216).
English: Amprenavir and ritonavir levels may increase on stopping St John's wort.
Slovak: Hladiny amprenaviru a ritonaviru sa po prerušení podávania ľubovníka bodkovaného môžu zvýšiť.
English: Proportion with HIV-1 RNA < 400 copies/ml
Slovak: RNA < 400 kópií/ml
English: • dolutegravir (used to treat HIV infection)
Slovak: • dolutegravir (používa sa na liečbu infekcie vírusom HIV)
English: telzir 700 mg
Slovak: INFORMÁCIE V BRAILLOVOM PÍSME telzir 700 mg
English: AUC ↓ 55% (-76%; -16%) Cmin ↓ 36 % (-57%; -3%)
Slovak: %; -16 %) Cmin ↓ 36 % (-57
English: Midazolam: ↑ expected (3-4 fold for parenteral midazolam)
Slovak: (3- až 4-násobne pri parenterálnom midazolame)
English: Headache, dizziness, oral paraesthesia
Slovak: Poruchy nervového systému Bolesť hlavy, závrat, orálna parestézia
English: Amprenavir Cmax ↔ Amprenavir AUC ↔ Amprenavir Cmin (C12h) ↔
Slovak: Amprenavir Cmin (C12h)
English: - alfuzosin (used to treat a prostate problem) - astemizole or terfenadine (commonly used to treat allergy symptoms - these medicines may be available without prescription) - pimozide (used to treat schizophrenia) - quetiapine (used to treat schizophrenia, bipolar disorder and major depressive disorder) - lurasidone (used to treat schizophrenia and bipolar disorder) - cisapride (used to relieve indigestion) - ergot derivatives (used to treat headaches) - rifampicin (used to treat tuberculosis) - amiodarone, quinidine, flecainide and propafenone (heart medicines) - bepridil (used to treat high blood pressure) - oral midazolam or oral triazolam (used to treat anxiety) - products containing St John's wort (Hypericum perforatum) - lovastatin, simvastatin (used to lower cholesterol) - sildenafil if used to treat pulmonary arterial hypertension, (a condition affecting the blood vessels to your lungs) - paritaprevir (used to treat hepatitis C virus infection)
Slovak: - lurazidón (používa sa na liečbu schizofrénie a bipolárnej poruchy) - cisaprid (používa sa na zmiernenie zažívacích ťažkostí) - deriváty ergotu (používajú sa na liečbu bolesti hlavy) - rifampicín (používa sa na liečbu tuberkulózy) - amiodarón, chinidín, flekainid a propafenón (lieky na srdce) - bepridil (používa sa na liečbu vysokého krvného tlaku)
English: In a randomised open-label study (APV30003) in protease inhibitor experienced patients with virological failure (less than or equal to two PIs) the fosamprenavir with ritonavir (700 / 100 mg twice daily or 1400 / 200 mg once daily) did not demonstrate non-inferiority to lopinavir / ritonavir with regard to viral suppression as measured by the average area under the curve minus baseline (AAUCMB) for plasma HIV-1 RNA over 48 weeks (the primary end point).
Slovak: u pacientov po predchádzajúcej liečbe inhibítorom proteázy s virologickým zlyhaním (menej ako dvoch PI alebo rovnajúce sa dvom PI) fosamprenavir s ritonavirom (700/100 mg dvakrát denne alebo 1 400/200 mg jedenkrát denne) nepreukázal nižšiu účinnosť ako lopinavir / ritonavir pokiaľ ide o vírusovú supresiu meranú priemernou plochou pod krivkou mínus bazálne (AAUCMB) hodnoty plazmatickej HIV-1
English: Median CD4 cells/μl CD4 count < 350 cells/μl, n (%)
Slovak: Medián počtu CD4 buniek/μl
English: Efavirenz 600 mg once daily
Slovak: Efavirenz 600 mg jedenkrát denne
English: ADRENORECEPTOR ANTAGONIST Alfuzosin,
Slovak: ANTAGONISTY ALPHA 1ADRENORECEPTOROV
English: Each tablet contains 700 mg of fosamprenavir as fosamprenavir calcium (equivalent to approximately 600 mg amprenavir).
Slovak: Každá tableta obsahuje 700 mg fosamprenaviru vo forme fosamprenaviru vápenatého (čo zodpovedá približne 600 mg amprenaviru).
English: Children from 6 years of age and weighing at least 39 kg Children can take the adult tablet dose of one 700 mg Telzir tablet twice daily with ritonavir 100 mg twice daily if they can swallow the tablets whole.
Slovak: Deti, ktoré vážia aspoň 39 kg a dokážu prehĺtať tablety, môžu užívať dávku pre dospelych, t.j. 700 mg tabletu Telziru dvakrát denne so 100 mg ritonaviru dvakrát denne.
English: Baseline HIV-1 RNA ≥ 100,000 copies/ml
Slovak: RNA ≥ 100 000 kópií/ml
English: The median durations of prior exposure to NRTIs were 257 weeks for patients receiving fosamprenavir with ritonavir twice daily (79 % had ≥ 3 prior NRTIs) and 210 weeks for patients receiving lopinavir/ritonavir (64 % had ≥ 3 prior NRTIs).
Slovak: Priemernou dĺžkou trvania predchádzajúcej expozície NRTI bolo 257 týždňov u pacientov užívajúcich fosamprenavir s ritonavirom dvakrát denne (79 % malo
English: No dosage adjustment of fosamprenavir or dolutegravir is recommended based on observed exposureresponse relationships of clinical data.
Slovak: Na základe klinických údajov o pozorovanom vzťahu medzi expozíciou liečivu a odpoveďou na liečbu sa neodporúča žiadna úprava dávkovania fosamprenaviru alebo dolutegraviru.
English: Telzir/ritonavir should not be co-administered with orally administered midazolam (see section 4.3), whereas caution should be used with co-administration of Telzir/ritonavir and parenteral midazolam.
Slovak: (pozri časť 4.3), pričom pri súbežnom podávaní Telziru/ritonaviru a parenterálneho midazolamu je potrebná opatrnosť.
English: PDE5 inhibitors used for the treatment of erectile dysfunction: The use of Telzir concomitantly with PDE5 inhibitors (e.g. sildenafil, tadalafil, vardenafil) is not recommended (see section 4.5).
Slovak: PDE5 (napr. sildenafilom,tadalafilom, vardenafilom) sa neodporúča (pozri časť 4.5).
English: ANTICONVULSANTS Phenytoin
Slovak: ANTIKONVULZÍVA Fenytoín
English: 400 mg/100 mg twice daily
Slovak: Lopinavir / ritonavir 400 mg/100 mg dvakrát denne
English: In adults, the oral suspension should be taken without food and on an empty stomach.
Slovak: U dospelých sa perorálna suspenzia musí užívať bez jedla a na prázdny žalúdok.
English: If you have severe liver disease the dose is 6 ml Telzir oral suspension (300 mg fosamprenavir) twice daily with 100 mg ritonavir only once daily.
Slovak: Ak máte závažné ochorenie pečene, dávka je 6 ml perorálnej suspenzie Telziru (300 mg fosamprenaviru) dvakrát denne so 100 mg ritonaviru iba jedenkrát denne.
English: Each film-coated tablet contains 700 mg fosamprenavir as fosamprenavir calcium (equivalent to approximately 600 mg of amprenavir)
Slovak: Každá filmom obalená tableta obsahuje 700 mg fosamprenaviru vo forme fosamprenaviru vápenatého (čo zodpovedá približne 600 mg amprenaviru)
English: (CYP2D6 inhibition by RTV)
Slovak: Inhibícia CYP2D6 prostredníctvom RTV
English: For adults with moderate hepatic impairment (Child-Pugh score: 7-9) the recommended dose is 450 mg fosamprenavir (i.e. 9 ml Telzir oral suspension) twice daily with 100 mg ritonavir once daily.
Slovak: U dospelých so stredne ťažkou poruchou funkcie pečene (Child-Pugh skóre: 7-9) je odporúčaná dávka fosamprenaviru 450 mg (t.j. 9 ml perorálnej suspenzie Telziru) dvakrát denne so 100 mg ritonaviru jedenkrát denne.
English: Don't stop Telzir without advice Take Telzir for as long as your doctor recommends.
Slovak: Neprestaňte užívať Telzir bez odporúčania
English: If you have mild liver disease, the dose is one Telzir tablet (700 mg) twice daily with 100 mg ritonavir only once daily.
Slovak: Ak máte mierne závažné ochorenie pečene, dávka je jedna tableta Telziru (700 mg) dvakrát denne so 100 mg ritonaviru iba jedenkrát denne.
English: If you have moderate liver disease the dose is 9 ml Telzir oral suspension (450 mg fosamprenavir) twice daily with 100 mg ritonavir only once daily.
Slovak: Ak máte stredne závažné ochorenie pečene, dávka je 9 ml perorálnej suspenzie Telziru (450 mg fosamprenaviru) dvakrát denne so 100 mg ritonaviru iba jedenkrát denne.
English: For adult patients the fosamprenavir oral suspension should be taken without food and on an empty stomach.
Slovak: U dospelých pacientov sa má perorálna suspenzia fosamprenaviru užívať bez jedla a na prázdny žalúdok.
English: Maraviroc: AUC12 ↑ 2.49 Maraviroc: Cmax ↑ 1.52
Slovak: 2,49 Maravirok: Cmax ↑
English: Non-inferiority was demonstrated between fosamprenavir co-administered with ritonavir and lopinavir / ritonavir based on the proportions of patients achieving plasma HIV-1 RNA levels < 400 copies/ml at 48 weeks (primary endpoint).
Slovak: Dokázalo sa, že neexistuje nižšia účinnosť medzi fosamprenavirom podávaným súčasne s ritonavirom a lopinavirom / ritonavirom na základe podielov pacientov dosahujúcich plazmatické hladiny HIV-1
English: Diarrhoea
Slovak: INFEKCIA
English: (CYP3A4 inhibition by FPV/RTV)
Slovak: (Inhibícia CYP3A4 prostredníctvom FPV/RTV)
English: For adults with mild hepatic impairment (Child-Pugh score: 5-6) the recommended dose is 700 mg fosamprenavir twice daily with 100 mg ritonavir once daily.
Slovak: U dospelých s miernou poruchou funkcie pečene (Child-Pugh skóre: 5-6) je odporúčaná dávka fosamprenaviru 700 mg dvakrát denne so 100 mg ritonaviru jedenkrát denne.
English: Astemizole: ↑ expected Terfenadine: ↑ expected
Slovak: Terfenadín: očakáva sa ↑
English: Norethisterone: Cmax ↓ 38% Norethisterone: AUC ↓ 34% Norethisterone: Cmin ↓ 26
Slovak: AUC ↓ 34 % Noretisterón:
English: When antineoplastic agents agents:
Slovak: Farmakoterapeutická skupina:
English: Despite reducing the dosing frequency of ritonavir, subjects with severe hepatic impairment had 64% higher ritonavir Cmax, 40% higher ritonavir AUC(0-24), and 38% higher ritonavir C12 than achieved in subjects with normal hepatic function receiving the standard fosamprenavir with ritonavir 700 mg / 100 mg twice daily regimen.
Slovak: vyššiu hodnotu Cmax ritonaviru, o 40 % vyššiu hodnotu AUC(0-24) ritonaviru a o 38 % vyššiu hodnotu C12 ritonaviru ako boli hodnoty dosiahnuté u jedincov s normálnou funkciou pečene, ktorí dostávali štandardný režim fosamprenaviru / ritonaviru 700 mg / 100 mg dvakrát denne.
English: Ritonavir AUC12 ↓ 0.66 Ritonavir Cmax ↓ 0.61 Ritonavir C12 ↔ 0.86
Slovak: 0,66 Ritonavir: Cmax ↓
English: Each ml of oral suspension contains 50 mg fosamprenavir as fosamprenavir calcium (equivalent to approximately 43 mg amprenavir).
Slovak: Každý ml suspenzie 50 mg fosamprenaviru vo forme fosamprenaviru vápenatého (čo zodpovedá približne 43 mg amprenaviru).
English: The relevance of the hepatocellular findings in the rodents for humans is uncertain; however, there is no evidence from clinical trials or marketed use to suggest that these findings are of clinical significance.
Slovak: neexistujú však žiadne dôkazy z klinických štúdií ani z používania na trhu, ktoré by svedčili o tom, že tieto nálezy sú klinicky významné.
English: Dihydroergotamine: ↑ expected
Slovak: Dihydroergotamín: očakáva sa ↑
English: ritonavir and ombitasvir other HIV protease inhibitors and co-administered with and paritaprevir/ritonavir/ dasabuvir)
Slovak: Paritaprevir (vo fixnej kombinácii s ritonavirom a ombitasvirom a podávaný súbežne s dasabuvirom)
English: Vardenafil
Slovak: Warfarín
English: ombitasvir +/- dasabuvir suggest that coadministration of fosamprenavir/ritonavir with paritaprevir/ritonavir/ ombitasvir+/-dasabuvir is likely to lead to increased plasma exposures of paritaprevir due to CYP3A4 enzyme inhibition and higher ritonavir dose.
Slovak: +/- dasabuvir pravdepodobne bude viesť k zvýšenej plazmatickej expozícii paritapreviru v dôsledku inhibície enzýmu CYP3A4 a vyššej dávky ritonaviru.
English: PHARMACEUTICAL FORM Oral suspension
Slovak: NA PERORÁLNU SUSPENZIU
English: and 6 patients from APV20003.
Slovak: Nežiaduce reakcie spojené s liečivom boli častejšie v štúdii APV20003
English: Cmax ↓ 56% (-70%; -34%) AUC ↓ 54% (-66%; -37%) Cmin ↓ 54 % (-74%; -18%)
Slovak: %; -37 %) Cmin ↓ 54 % (-74
English: INFECTION Antibacterials:
Slovak: HIV infekcie.
English: NAME OF THE MEDICINAL PRODUCT Telzir 700 mg film-coated tablets
Slovak: Telzir 700 mg filmom obalené tablety
English: For adults with moderate hepatic impairment (Child-Pugh score: 7-9) the recommended dose is 450 mg fosamprenavir twice daily with 100 mg ritonavir once daily.
Slovak: U dospelých so stredne ťažkou poruchou funkcie pečene (Child-Pugh skóre: 7-9) je odporúčaná dávka fosamprenaviru 450 mg dvakrát denne so 100 mg ritonaviru jedenkrát denne.
English: Amprenavir: Cmax ↔ Amprenavir: AUC ↔
Slovak: Amprenavir: AUC ↓
English: 400 mg twice daily
Slovak: 300 mg dvakrát denne
English: Cmax ↓ 24% AUC ↓ 35% Cτ ↓ 49%
Slovak: Dolutegravir Cmax ↓ 24 % AUC ↓
English: Children 6 to 11 years of age (n=9) receiving fosamprenavir / ritonavir 18 / 3 mg/kg twice daily had 26 % higher AUC(0-24) and similar Cmax and Cmin values when compared to the historical adult population receiving fosamprenavir / ritonavir 700 / 100 mg twice daily.
Slovak: 9), ktoré užívali fosamprenavir / ritonavir 18 / 3 mg/kg dvakrát denne, o 26 % vyššiu hodnotu AUC(0-24) a podobnú hodnotu Cmax a hodnotu Cmin.
English: Drug-related adverse reactions were more common in APV20003 (57%) where subjects received once daily fosamprenavir / ritonavir when compared to APV29005 (33%) where subjects received twice daily fosamprenavir / ritonavir.
Slovak: %), v ktorej jedinci užívali fosamprenavir / ritonavir jedenkrát denne v porovnaní so štúdiou APV29005 (33
English: (Modest induction of CYP3A4 by FPV/RTV)
Slovak: (Indukcia CYP3A4 prostredníctvom FPV/RTV)
English: Amprenavir AUC ↑↑ 69% Amprenavir Cmin ↑ 77% Amprenavir Cmax ↑ 62%
Slovak: ↑ 69 % Amprenavir Cmin ↑
English: Amprenavir: Cmax ↔ Amprenavir: AUC ↑ 20% Amprenavir: Cmin ↑ 19%
Slovak: 20 % Amprenavir: Cmin ↑
English: Change from baseline in CD4 cells (cells/µl)
Slovak: Zmena od bazálneho počtu CD4 buniek
English: Not studied.
Slovak: Nesledovali sa.
English: Blood cholesterol increased Blood triglycerides increased Alanine aminotransferase increased
Slovak: Zvýšené hladiny cholesterolu v krvi
English: NEUROLEPTIC Pimozide
Slovak: Mikrokryštalická celulóza
English: All Subjects
Slovak: LÁTKY
English: (Mixed CYP3A4 induction/inhibition)
Slovak: (Zmiešaná indukcia/inhibícia CYP3A4)
English: Old infections may flare up
Slovak: Hemofilici môžu viac krvácať
English: Cmax ↓ 25% (-41%; -4%) AUC ↓ 25% (-42%; -3%) Cmin ↓ 33% (-50%; -10%)
Slovak: %; -3 %) Cmin ↓ 33 % (-50
English: Harmire Road Barnard Castle Co. Durham DL12 8DT United Kingdom
Slovak: Durham DL12 8DT
English: Clinical experience with fosamprenavir boosted with ritonavir is mainly based on two open label studies, one in antiretroviral naïve patients (study ESS100732), and one study in antiretroviral experienced patients (study APV30003).
Slovak: Jedna štúdia u pacientov bez predchádzajúcej antiretrovírusovej liečby (štúdia ESS100732) a jedna štúdia u pacientov po predchádzajúcej antiretrovírusovej liečbe (štúdia
English: Lovastatin Simvastatin
Slovak: Lovastatín Simvastatín
English: Greater effects may be expected when fluticasone propionate is inhaled.
Slovak: ak je flutikazónpropionát inhalovaný.
English: Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Polysorbate 80
Slovak: Propylénglykol Metylparabén (E218)
English: Flecainide: ↑ expected
Slovak: Metylergonovín: očakáva sa
English: Significant
Slovak: Nalačno
English: Norethisterone: Cmax
Slovak: Noretisterón: Cmax ↓
English: Bottle with 225 ml oral suspension A 10 ml graduated dosing syringe and adapter are also provided in the pack
Slovak: Fľaša s 225 ml perorálnej suspenzie
English: Solution
Slovak: PODMIENKY
English: Simeprevir
Slovak: IMUNOSUPRESÍVA
English: There have been reports of increased bleeding including spontaneous skin haematomas and haemarthroses in haemophiliac patients type A and B treated with protease inhibitors (PIs).
Slovak: A a B liečených inhibítormi proteázy (PI) boli zaznamenané prípady zvýšeného krvácania vrátane spontánnych kožných hematómov a hemartróz.
English: Amprenavir: Cmax ↓ 13%* Amprenavir: AUC ↓ 26%* Amprenavir: Cmin ↓ 42 %* * compared to fosamprenavir / ritonavir 700 mg/100 mg twice daily
Slovak: %* * v porovnaní s fosamprenavirom / ritonavirom 700 mg/100 mg dvakrát denne
English: • The active substance is fosamprenavir.
Slovak: Liečivo je fosamprenavir.
English: mechanism of interaction is CYP3A4 inhibition by fosamprenavir/ritonavir.
Slovak: A4 prostredníctvom fosamprenaviru/ritonaviru.
English: 225 ml oral suspension A 10 ml graduated dosing syringe and adapter are also provided in the pack
Slovak: Súčasťou balenia je aj 10 ml dávkovacia striekačka a nástavec
English: Subjects (%) with plasma HIV-1 RNA <400 copies/ml
Slovak: (%) s plazmatickým HIV-1
English: - lopinavir/ritonavir combination (used to treat HIV infection) - raltegravir (used to treat HIV infection) - , , simeprevir, daclatasvir (used to treat hepatitis C virus infection) - maraviroc (used to treat HIV infection)
Slovak: - lieky obsahujúce ľubovník bodkovaný (Hypericum perforatum) - lovastatín, simvastatín (používajú sa na zníženie hladiny cholesterolu) - sildenafil, ak sa používa na liečbu pľúcnej arteriálnej hypertenzie (ochorenie postihujúce cievy vo vašich pľúcach)
English: INHALED/NASAL STEROIDS
Slovak: INHALAČNÉ/NAZÁLNE
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 700 mg of fosamprenavir as fosamprenavir calcium (equivalent to approximately 600 mg of amprenavir).
Slovak: Každá filmom obalená tableta obsahuje 700 mg fosamprenaviru vo forme fosamprenaviru vápenatého (čo zodpovedá približne 600 mg amprenaviru).
English: Proportion with HIV-1 RNA < 50 copies/ml
Slovak: RNA log10 kópií/ml
English: Amprenavir: Cmax ↓ 51% Amprenavir: AUC ↓ 30% Amprenavir: Cmin (C12h) ↔
Slovak: 30 % Amprenavir: Cmin (C12h)
English: fosamprenavir/ritonavir, plasma concentrations of these antineoplastic medications may be increased and could increase the risk of adverse events usually associated with these antineoplastic agents.
Slovak: (napríklad dasatinib, nilotinib, ibrutinib, vinblastín a everolimus) môže zvyšovať koncentrácie týchto látok, čo môže zvyšovať riziko vzniku nežiaducich udalostí, ktoré sú zvyčajne spájané s týmito látkami.
English: Children and adolescents: the adverse reaction profile in children and adolescents is based on integrated safety data from two studies (APV29005 Week 24 data and APV20003 Week 168 data [final data]) in which 158 HIV-1 infected subjects 2 to 18 years of age received fosamprenavir with ritonavir with background nucleoside reverse transcriptase inhibitor therapy (see section 5.1 for information on dosing regimens applied for each age group).
Slovak: Profil nežiaducich reakcií u detí a dospievajúcich vychádza z integrovaných údajov o bezpečnosti z dvoch štúdií (24-týždňové údaje zo štúdie APV29005 a 168-týždňové údaje
English: If you have mild liver disease, the dose is 14 ml Telzir oral suspension (700 mg fosamprenavir) twice daily with 100 mg ritonavir only once daily.
Slovak: Dospelí s ochorením pečene Ak máte mierne závažné ochorenie pečene, dávka je 14 ml perorálnej suspenzie Telziru (700 mg fosamprenaviru) dvakrát denne so 100 mg ritonaviru iba jedenkrát denne.
English: telzir 50 mg/ml
Slovak: INFORMÁCIE V BRAILLOVOM PÍSME telzir 50 mg/ml
English: Mean (n)
Slovak: Priemer (n)
English: Lovastatin: ↑ expected Simvastatin: ↑ expected
Slovak: dasatinib: očakáva sa ↑ nilotinib: očakáva sa ↑ ibrutinib: očakáva sa ↑ vinblastín: očakáva sa ↑ everolimus: očakáva sa ↑
English: All Subjects Baseline HIV-1 RNA < 100,000 copies/ml
Slovak: RNA < 100 000 kópií/ml
English: In subjects with mild hepatic impairment (Child-Pugh score of 5-6), the dosage regimen of fosamprenavir 700 mg twice daily with a reduced dosing frequency of ritonavir 100 mg once daily provided slightly higher plasma amprenavir Cmax (17 %), slightly higher plasma amprenavir AUC(0-12) (22 %), similar plasma total amprenavir C12 values and approximately 117 % higher plasma unbound amprenavir C12 values compared to subjects with normal hepatic function receiving the standard fosamprenavir / ritonavir 700 mg /100 mg twice daily regimen.
Slovak: U jedincov s miernou poruchou funkcie pečene (Child-Pugh skóre 5-6) viedol dávkovací režim fosamprenaviru 700 mg dvakrát denne so zníženou frekvenciou dávkovania ritonaviru 100 mg jedenkrát denne k mierne vyššej hodnote Cmax amprenaviru v plazme (o 17
English: ANTIARRHYTHMICS
Slovak: ANTIARYTMIKÁ
English: TELZIR/ritonavir with which can result in alfuzosin is contraindicated hypotension.
Slovak: Telzir/ritonavir sa nesmú podávať súbežne s perorálne podávaným midazolamom
English: (CYP3A4 induction by FPV/RTV)
Slovak: CYP3A4 prostredníctvom FPV/RTV)
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Slovak: VONKAJŠÍ OBAL/PAPIEROVÁ SKLADAČKA
English: If you are breast-feeding, or thinking about breast-feeding: →Talk to your doctor immediately.
Slovak: Ak dojčíte alebo ak uvažujete o dojčení:
English: • Change in your body shape
Slovak: • znovuvzplanutie predchádzajúcich infekcií, • zmenu tvaru tela,
English: FPV/RTV 700 mg/100 mg
Slovak: FPV/RTV 700 mg/100 mg BID (n =
English: AUC ↓ 16% (-36%; +8%) Cmin ↓ 19% (-42%; +13%)
Slovak: %; +8 %) Cmin ↓
English: • Diarrhoea
Slovak: Atorvastatín
English: Rapamycin
Slovak: Flekainid
English: LPV/RTV BID (N=103)
Slovak: LPV/RTV BID
English: failure in patients.
Slovak: môže viesť k virologickému zlyhaniu u pacientov.
English: ADRENORECEPTOR ANTAGONIST
Slovak: ANTACIDÁ, ANTAGONISTA H2
English: Amprenavir: AUC12 ↓ 0.65 Amprenavir: Cmax ↓ 0.66
Slovak: 0,65 Amprenavir: Cmax ↓
English: Lopinavir: Cmax ↔* Lopinavir: AUC ↔* Lopinavir: Cmin ↔* * compared to lopinavir / ritonavir 400 mg/100 mg twice daily
Slovak: Lopinavir: Cmax ↔* Lopinavir: AUC ↔* Lopinavir: Cmin ↔*
English: Erythromycin: ↑ expected (CYP3A4 inhibition by FPV/RTV
Slovak: Inhibícia CYP3A4 prostredníctvom FPV/RTV
English: Loose stools, nausea, vomiting, abdominal pain
Slovak: - kvetiapín (používa sa na liečbu schizofrénie, bipolárnej poruchy a veľkej depresie)
English: The plasma amprenavir pharmacokinetics were evaluated in a 14 day repeat-dose study in HIV-1 infected adult subjects with mild, moderate, or severe hepatic impairment receiving fosamprenavir with ritonavir compared to matched control subjects with normal hepatic function.
Slovak: Farmakokinetika amprenaviru v plazme bola hodnotená v 14-dňovej štúdii opakovanej dávky u HIV-1
English: Angioedema
Slovak: Astemizol
English: Capsule or Solution
Slovak: Tableta alebo perorálna suspenzia
English: 90 x 1 tablets (unit dose)
Slovak: 90 x 1 tableta (jednotlivá dávka)
English: 20 ml
Slovak: 20m
English: Solution for injection Intravenous use vial (glass)
Slovak: Intravenózne použitie Injekčná liekovka (sklo)
English: 32.27 g
Slovak: Prášok: 32,27 g 1 fľaška
English: Powder for oral suspension bottle (glass)
Slovak: 1 injekčná liekovka prášok na peroránu suspenziu fľaška (sklo)
English: l t o r
Slovak: Veľkosť balenia k s
English: EMA/116425/2013 EMEA/H/C/002400
Slovak: EMEA/H/C/002400
English: This summary was last updated in 2-2013.
Slovak: Posledná aktualizácia tohto súhrnu: 2-2013
English: Agitation is a known complication of both mental illnesses.
Slovak: Nepokoj je známou komplikáciou pri oboch týchto duševných chorobách.
English: The full EPAR for Adasuve can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovak: Úplné znenie správy EPAR o lieku Adasuve sa nachádza na internetovej stránke agentúry: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Regarding its safety, most side effects are comparable to those of other antipsychotic medicines.
Slovak: Pokiaľ ide o jeho bezpečnosť, väčšina vedľajších účinkov je porovnateľná s vedľajšími účinkami iných antipsychotík.
English: Adasuve should only be used in a hospital under the supervision of a healthcare professional.
Slovak: Adasuve sa má používať len v nemocnici pod dohľadom zdravotníckeho pracovníka.
English: Adasuve has been studied in two main studies.
Slovak: Adasuve sa skúmal v dvoch hlavných štúdiách.
English: The potential risk of bronchospasm is considered manageable and has been adequately addressed through risk minimisation measures.
Slovak: Potenciálne riziko bronchospazmu sa považuje za zvládnuteľné a bolo dostatočne vyriešené prostredníctvom opatrení na minimalizáciu rizika.
English: Its action on receptors for other neurotransmitters may also play a role.
Slovak: Určitú úlohu môže mať aj jeho účinok na receptory pre iné neurotransmitery.