natgillin/translations-raw huggingface dataset:
In the studies of PI-experienced patients, APV30003 and its extension, APV30005 (fosamprenavir 700 mg / ritonavir 100 mg twice daily: n=107), the following mutations emerged in patients experiencing virological failure through 96 weeks: L10F/I, L24I, V32I, L33F, M36I, M46I/L, I47V, I50V, I54L/M/S, A71I/T/V, G73S, V82A, I84V, and L90M.
V študijah bolnikov, ki so že bili zdravljeni z zaviralci proteaz, APV30003 in njenem podaljšku, APV30005 (fosamprenavir 700 mg / ritonavir 100 mg dvakrat na dan: n=107), so se pri bolnikih z virusnim neodzivom med 96 tedni zdravljenja pojavile naslednje mutacije: L10F/I, L24I, V32I, L33F, M36I, M46I/L, I47V, I50V, I54L/M/S, A71I/T/V, G73S, V82A, I84V in L90M.
Ketoconazole / Itraconazole: the AUC and Cmax of ketoconazole were increased by 44 % and 19 % respectively when given with amprenavir.
Ketokonazol/itrakonazol: Pri sočasni uporabi ketokonazola in amprenavirja sta se AUC in Cmax ketokonazola zvišali, in sicer AUC za 44 %, Cmax pa za 19 %.
Agenerase oral solution is also contraindicated in patients treated with disulfiram or other medicinal products that reduce alcohol metabolism (e.g. metronidazole) and preparations that contain alcohol (e.g. ritonavir oral solution) or additional propylene glycol (see section 4.4and 5.1).
Ravno tako je peroralna raztopina Agenerase kontraindicirana pri bolnikih, ki se zdravijo z disulfiramom ali drugimi zdravili, ki zmanjšujejo presnovo alkohola (npr. metronidazol), pripravki z alkoholom (npr. peroralna raztopina ritonavirja) ali pripravki z dodatnim propilenglikolom (glejte poglavji 4.4 in 5.1).
Adults and adolescents of 12 years of age and older (greater than 50 kg body weight): the recommended dose of Agenerase capsules is 600 mg twice daily with ritonavir, 100 mg twice daily, in combination with other antiretroviral agents.
Odrasli in mladostniki, stari 12 let ali več (s telesno maso, večjo od 50 kg): Priporočen odmerek kapsul Agenerase je 600 mg dvakrat dnevno skupaj z ritonavirjem v odmerku 100 mg dvakrat dnevno in v kombinaciji z drugimi protiretrovirusnimi zdravili.
No dose adjustment is necessary for either medicinal product when nelfinavir is administered in combination with amprenavir (see also efavirenz below).
Ob sočasni uporabi nelfinavirja in amprenavirja njunih odmerkov ni potrebno prilagajati (glejte tudi Efavirenz spodaj).
• Pain, discomfort or excess acid in the stomach, loose stools,
• Bolečina in neugodje v želodcu.
HIV-1 isolates with decreased susceptibility to amprenavir have been selected during in vitro serial passage experiments.
Med serijskimi pasažami in vitro so izolirali izolate virusa HIV-1 z zmanjšano občutljivostjo za amprenavir.
The AUC, Cmin and Cmax of amprenavir were increased by 33 %, 25 %, and 18 %, respectively.
AUC, Cmin in Cmax amprenavirja so se zvečale: AUC za 33 %, Cmin za 25 % in Cmax za 18 %.
Agenerase capsules should be used with caution in patients with hepatic impairment.
Pri bolnikih z oslabljenim delovanjem jeter je potrebna previdnost pri uporabi kapsul Agenerase.
Saquinavir: the AUC, Cmin and Cmax of saquinavir were decreased by 19 % and 48 % and increased by 21 %, respectively, when given with amprenavir.
Sakvinavir: Ob sočasnem dajanju z amprenavirjem sta se AUC in Cmin sakvinavirja zmanjšali, in sicer AUC za 19 %, Cmin pa za 48 %; Cmax sakvinavirja se je zvišala za 21 %.
Agenerase can be taken with or without food.
Zdravilo Agenerase smete jemati s hrano ali brez nje.
Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk for severe and potentially fatal liver adverse events and may require blood tests for control of liver function.
Pri bolnikih s kroničnim hepatitisom B ali C, ki se zdravijo s protiretrovirusnimi zdravili, obstaja povečano tveganje za pojav hudih, lahko tudi usodnih, z jetri povezanih neželenih učinkov.
When ART naïve patients were treated with the currently approved doses of fosamprenavir/ritonavir, as for other ritonavir boosted PI regimens, the mutations described were rarely observed.
Pri bolnikih, ki se predhodno še niso zdravili s protiretrovirusnimi zdravili, so se pri zdravljenju s trenutno priporočenimi odmerki fosamprenavirja/ritonavirja opisane mutacije pojavile redko, podobno kot pri drugih režimih zdravljenja z zaviralci proteaz z okrepitvijo z ritonavirjem.
The AUC, Cmin and Cmax of amprenavir were increased by 18 %, 39 %, and 15 % respectively.
AUC, Cmin in Cmax amprenavirja so se zvečale, in sicer AUC za 18 %, Cmin za 39 % in Cmax za 15 %.
What Agenerase looks like and the contents of the pack Agenerase 150 mg soft capsules are supplied in plastic bottles containing 240 soft capsules.
Zdravilo Agenerase v obliki 150 mg mehkih kapsul je na voljo v plastenkah, ki vsebujejo 240 mehkih kapsul.
The AUC, Cmin and Cmax of amprenavir were decreased by 32 %, 14 %, and 37 %, respectively.
AUC, Cmin in Cmax amprenavirja so se zmanjšale: AUC za 32 %, Cmin za 14 % in Cmax za 37 %.
This is due to induction of drug metabolising enzymes by St John's wort.
Slednje je posledica šentjanževkine indukcije presnovnih encimov zdravila.
The AUC, Cmin and Cmax of amprenavir were increased by 29 %, 27 %, and 47 %, respectively.
AUC, Cmin in Cmax amprenavirja so se zvečale: AUC za 29 %, Cmin za 27 % in Cmax za 47 %.
Agenerase oral solution is supplied in plastic bottles containing 240 ml of oral solution.
Peroralna raztopina Agenerase je na voljo v plastenkah, ki vsebujejo 240 ml peroralne raztopine.
Psychiatric disorders Common:
Bolezni živčevja Zelo pogosti:
Nelfinavir: the AUC, Cmin and Cmax of nelfinavir were increased by 15 %, 14 %, and 12 % respectively when given with amprenavir.
Nelfinavir: Ob sočasnem dajanju z amprenavirjem so se AUC, Cmin in Cmax nelfinavirja zvečale, in sicer AUC za 15 %, Cmin za 14 % in Cmax za 12 %.
For the same reason you must not take disulfiram or other medicines that reduce alcohol metabolism (e.g. metronidazole) or preparations that contain alcohol (e.g. ritonavir oral solution) or additional propylene glycol while you are taking Agenerase oral solution (see also Do not take Agenerase).
Iz istega razloga peroralne raztopine Agenerase ne smete jemati sočasno z disulfiramom ali drugimi zdravili, ki zmanjšujejo presnovo alkohola (npr. metronidazol), s pripravki z alkoholom (npr. peroralna raztopina ritonavirja) ali s pripravki z dodatnim propilenglikolom (glejte tudi Ne jemljite zdravila Agenerase).
Concomitant administration should be used with caution in patients with mild and moderate hepatic impairment and is contraindicated in patients with severe hepatic impairment (see section 4.3).
Pri bolnikih z blažjo ali zmerno obliko oslabljenega delovanja jeter je potrebna previdnost pri sočasnem dajanju, pri bolnikih s hudo obliko oslabljenega delovanja jeter pa je sočasno dajanje kontraindicirano (glejte poglavje 4.3).
No dose recommendations can be given for the co-administration of amprenavir and low dose ritonavir with delavirdine.
Za sočasno uporabo amprenavirja, nizkih odmerkov ritonavirja in delavirdina ne moremo podati priporočenih odmerkov.
The Summary of Product Characteristics of Agenerase oral solution should be consulted for full prescribing information.
Pred predpisovanjem je potrebno preveriti popolna navodila, ki so v Povzetku glavnih značilnosti zdravila za peroralno raztopino Agenerase.
- There have been reports of increased bleeding in patients with haemophilia taking protease inhibitors.
- Pri bolnikih s hemofilijo, ki so prejemali zaviralce proteaz, so poročali o pogostnejših krvavitvah.
The concomitant administration of Agenerase oral solution with disulfiram or other medicinal products that reduce alcohol metabolism (e.g. metronidazole), or preparations that contain alcohol (e.g. ritonavir oral solution) or additional propylene glycol is contraindicated (see sections 4.3and 4.5).
Uporaba peroralne raztopine Agenerase sočasno z disulfiramom ali drugimi zdravili, ki zmanjšujejo presnovo alkohola (npr. metronidazol), s pripravki z alkoholom (npr. peroralna raztopina ritonavirja) ali s pripravki z dodatnim propilenglikolom je kontraindicirana (glejte poglavji 4.3 in 4.5).
No dose recommendation can be given for the co-administration of amprenavir with another protease inhibitor and efavirenz in children.
Za sočasno uporabo amprenavirja, drugega zaviralca proteaz in efavirenza pri otrocih ne moremo podati priporočenih odmerkov.
Co-administration may result in competitive inhibition of the metabolism of these active substances thus increasing their plasma level and leading to serious and / or life-threatening adverse reactions such as cardiac arrhythmia (e.g. amiodarone, astemizole, bepridil, cisapride, pimozide, quinidine, terfenadine) or peripheral vasospasm or ischaemia (e.g. ergotamine, dihydroergotamine).
Zaradi sočasne uporabe se lahko pojavi kompetitivna presnova teh učinkovin in posledično povečanje njihovih plazemskih vrednosti, kar lahko povzroči resne in/ali smrtno nevarne neželene reakcije, kot so aritmije (npr. amiodaron, astemizol, bepridil, cisaprid, pimozid, kinidin, terfenadin) ali periferni vazospazem ali ishemija (npr. ergotamin, dihidroergotamin).
NAME OF THE MEDICINAL PRODUCT Agenerase 150 mg soft capsules Amprenavir
IME ZDRAVILA Agenerase 150 mg mehke kapsule amprenavir
Based on these data, careful consideration should be given to the expected benefit of unboosted Agenerase when optimising therapy for PI experienced children.
Pri otrocih, ki so se že zdravili s PI-ji, je na osnovi teh podatkov pri izbiranju najboljše oblike zdravljenja treba skrbno razmisliti o koristi uporabe zdravila Agenerase brez okrepitve.
Oblong, opaque, off-white to cream coloured, printed with ‘GX CC1'.
Podolgovate, neprozorne, sivobele do krem barve, z oznako ‘GX CC1'.
NAME OF THE MEDICINAL PRODUCT Agenerase 50 mg soft capsules Amprenavir
IME ZDRAVILA Agenerase 50 mg mehke kapsule amprenavir
Zidovudine: the AUC and Cmax of zidovudine were increased by 31 % and 40 %, respectively, when given with amprenavir.
Zidovudin: Ob sočasnem dajanju z amprenavirjem sta se AUC in Cmax zidovudina zvečali, in sicer AUC za 31 % ter Cmax za 40 %.
You will need to take Agenerase every day.
Bodite posebno pozorni pri jemanju zdravila Agenerase Zdravilo Agenerase morate jemati vsak dan.
One hundred and sixty-three (163) patients with virus sensitive to Agenerase, at least one other PI, and at least one NRTI were included in PRO30017 substudy A. The primary analysis assessed the noninferiority of APV/r to the SOC PI group with respect to time-weighted average change from baseline (AAUCMB) in plasma viral load (HIV-1 RNA) at week 16 using a non-inferiority margin of 0.4 log10 copies/ml.
Primarna analiza je vrednotila enakovrednost APV/r v primerjavi s skupino, ki je bila standardno zdravljena s PI-ji, glede na časovno odvisne povprečne spremembe od izhodišča (AAUCMB) v plazemski virusni obremenitvi (HIV-1 RNA) v 16. tednu z uporabo enakovredne meje 0,4 log10 kopij/ml.
Breast feeding your baby is not recommended while you are taking Agenerase.
Medtem ko jemljete zdravilo Agenerase, ni priporočljivo, da otroka dojite.
No dosing recommendations can be made regarding the use of low dose ritonavir (normally used as an activity booster with Agenerase capsules) together with Agenerase oral solution.
Glede uporabe nizkega odmerka ritonavirja (običajno se uporablja za okrepitev učinka zdravila Agenerase v obliki kapsul) skupaj s peroralno raztopino Agenerase ne moremo podati priporočenih odmerkov, zato se je takšni kombinaciji potrebno izogibati.
Children less than 4 years of age: Agenerase oral solution is contraindicated in children less than 4 years of age.
Otroci, mlajši od 4 let: Peroralna raztopina Agenerase je kontraindicirana pri otrocih, mlajših od 4 let (glejte poglavji 4.3 in 5.3).
Agenerase should be permanently discontinued when rash is accompanied with systemic symptoms or allergic symptoms or mucosal involvement (see section 4.8).
Če eksantem spremljajo sistemski znaki, znaki alergije ali prizadetost sluznic, je potrebno uporabo zdravila Agenerase trajno ukiniti (glejte poglavje 4.8).
Hyperglycaemia, hypercholesterolaemia
hiperholesterolemija
Agenerase capsules are contraindicated in patients with severe hepatic impairment when used in combination with ritonavir (see section 4.3).
Uporaba kapsul Agenerase v kombinaciji z ritonavirjem je kontraindicirana pri bolnikih s hudo obliko oslabljenega delovanja jeter (glejte poglavje 4.3).
Lamivudine: the AUC and Cmax of lamivudine and amprenavir, respectively, were both unaltered when these two medicinal products were given concomitantly.
Lamivudin: Ob sočasnem dajanju z amprenavirjem sta AUC in Cmax lamivudina in amprenavirja ostali nespremenjeni.
Agenerase is also available as an oral solution for use in children or adults unable to swallow capsules.
Za uporabo pri otrocih in odraslih, ki niso zmožni pogoltniti kapsul, je zdravilo Agenerase na voljo tudi v obliki peroralne raztopine.
• Increases in enzymes produced by the liver called transaminases, increases of an enzyme produced by the pancreas called amylase
• Povečana aktivnost jetrnih encimov (transaminaze) in povečana aktivnost encima
Additionally, it is recommended that HIV infected women do not breast feed their infants in order to avoid transmission of HIV.
Dodatno je, z namenom preprečiti širjenje virusa, ravno tako priporočljivo, da matere, okužene z virusom HIV, otrok ne dojijo.
New onset of diabetes mellitus, hyperglycaemia or exacerbations of existing diabetes mellitus have been reported in patients receiving antiretroviral therapy, including protease inhibitors.
Pri bolnikih, ki so prejemali protiretrovirusna zdravila, vključno zaviralce proteaz, so poročali o pojavu sladkorne bolezni, o hiperglikemiji ali poslabšanju obstoječe sladkorne bolezni.
Abacavir: the AUC, Cmin and Cmax of abacavir were unaltered when given with amprenavir.
Abakavir: Ob sočasnem dajanju z amprenavirjem so AUC, Cmin in Cmax abakavirja ostale nespremenjene.
Patients should therefore be monitored for toxic reactions associated with these medicinal products when these are administered in combination with Agenerase.
V primeru sočasne uporabe teh zdravil in zdravila Agenerase je bolnike potrebno nadzirati glede morebitnih toksičnih reakcij, povezanih z njimi.
This must be taken into consideration when prescribing to patients on a controlled sodium diet.
Pozornost je potrebna pri bolnikih, ki so na diati z nižanjem natrija.
Oral/perioral paraesthesia, tremors, sleep disorders Gastrointestinal disorders Very Common:
oralna/perioralna parestezija, tremor, motnje spanja
Co-administration may result in competitive inhibition of the metabolism of these active substances thus increasing their plasma level and leading to serious and / or life-threatening adverse reactions such as cardiac arrhythmia (e.g. amiodarone, astemizole, bepridil, cisapride, pimozide, quinidine, terfenadine) or peripheral vasospasm or ischaemia (e.g. ergotamine, dihydroergotamine) (see section
Zaradi sočasne uporabe se lahko pojavi kompetitivna presnova teh učinkovin in posledično povečanje njihovih plazemskih vrednosti, kar lahko povzroči resne in/ali smrtno nevarne neželene reakcije, kot so aritmije (npr. amiodaron, astemizol, bepridil, cisaprid, pimozid, kinidin, terfenadin) ali periferni vazospazem ali ishemija (npr. ergotamin, dihidroergotamin) (glejte poglavje 4.3).
Clinically validated phenotypic interpretation systems may be used in association with the genotypic data to estimate the activity of amprenavir / ritonavir or fosamprenavir / ritonavir in patients with PIresistant isolates.
Analize na osnovi fenotipskega testiranja rezistence Za ocenjevanje delovanja amprenavirja /ritonavirja ali fosamprenavirja /ritonavirja pri bolnikih z izolati, odpornimi na zaviralce proteaz, se lahko uporabijo klinično ovrednoteni fenotipski interpretacijski sistemi v kombinaciji z genotipskimi podatki.
No dose adjustment for any of the medicinal products is necessary when either ketoconazole is or itraconazole administered in combination with amprenavir.
Pri sočasni uporabi ketokonazola ali itrakonazola in amprenavirja ni treba prilagajati odmerka pri nobenem zdravilu.
PACKAGE LEAFLET : INFORMATION FOR THE USER Agenerase 15 mg/ml oral solution Amprenavir
NAVODILO ZA UPORABO Agenerase 15 mg/ml peroralna raztopina amprenavir
Agenerase oral solution and ritonavir oral solution should not be co-administered (see section 4.3).
Peroralna raztopina Agenerase in peroralna raztopina ritonavirja se ne smeta uporabljati sočasno (glejte poglavje 4.3).
• Diarrhoea, feeling sick, vomiting, flatulence • Skin Rashes (red, raised or itchy) - Occasionally, the skin rash may be svere and you may
• Kožni izpuščaj (rdeč, privzdignjen nad nivo kože ali srbeč).
Therefore, concomitant administration with disulfiram or other medicinal products that reduce alcohol metabolism (e.g. metronidazole) or preparations that contain alcohol (e.g. ritonavir oral solution) or propylene glycol is contraindicated (see sections 4.3 and 4.4).
Tako je sočasna uporaba peroralne raztopine Agenerase in disulfirama ali drugih zdravil, ki zmanjšujejo presnovo alkohola (npr. metronidazol), pripravkov z alkoholom (npr. peroralna raztopina ritonavirja) ali pripravkov s propilenglikolom kontraindicirana (glejte poglavji 4.3 in 4.4).
Oblong, opaque, off-white to cream coloured, printed with ‘GX CC2'.
Podolgovate, neprozorne, sivobele do krem barve, z oznako ‘GX CC2'.
Atorvastatin is less dependent on CYP3A4 for metabolism.
Atorvastatin je pri presnovi sicer manj odvisen od CYP3A4, vendar je, pri sočasni uporabi z zdravilom Agenerase, potrebno uporabiti najnižji možni odmerek atorvastatina.
Steroids: oestrogens and progestogens may interact with amprenavir.
Steroidi: Estrogeni in progestogeni lahko medsebojno učinkujejo z amprenavirjem, vendar trenutno dostopni podatki ne zadostujejo za opredelitev narave interakcij.
EFFECTIVE USE OF THE MEDICINAL PRODUCT Not applicable
Imetnik dovoljenja za promet z zdravilom
Do not take Agenerase if you are allergic (hypersensitive) to amprenavir or to any of the other ingredients in if you have severe liver disease (see ‘Take special care with Agenerase').
- če imate hudo bolezen jeter (glejte 'Bodite posebno pozorni pri jemanju zdravila Agenerase').
This product contains propylene glycol, potassium and sodium See leaflet for further information
To zdravilo vsebuje propilenglikol, kalij in natrij.
No recommendations can currently be made regarding adjustment of amprenavir dose when amprenavir is co-administered with methadone due to the inherent low reliability of nonmatched historical controls.
Zaradi svojstvene nizke zanesljivosti neenakovredne kontrolne historične skupine trenutno ne moremo podati priporočil glede prilagoditve odmerka amprenavirja, če se uporablja sočasno z metadonom.
Musculoskeletal and connective tissue disorders
Bolezni kosti, sklepov, mišic in vezivnega tkiva
Consequently, concomitant administration of Agenerase with ritonavir and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Omenjeni sistemski kortikosteroidni učinki se lahko pojavijo tudi pri uporabi drugih kortikosteroidov, ki se presnavljajo s P450 3A, npr. budezonid, zato sočasne uporabe zdravila Agenerase v kombinaciji z ritonavirjem in tovrstnimi glukokortikoidi ne priporočamo, razen v primerih, ko možne koristi zdravljenja prevladajo nad tveganjem za pojav sistemskih kortikosteroidnih učinkov (glejte poglavje 4.4).
Österreich GlaxoSmithKline Pharma GmbH
GlaxoSmithKline GmbH & Co.
A reduction of rifabutin dosage of at least 50 % is recommended when administered with Agenerase.
Če se rifabutin daje sočasno z zdravilom Agenerase priporočamo, da se odmerek rifabutina zmanjša vsaj za 50 %.
Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate; this could also occur with other corticosteroids metabolised via the P450 3A pathway e.g. budesonide.
Pri bolnikih, ki so prejemali ritonavir in inhalacijske ali intranazalne oblike flutikazonpropionata, so poročali o pojavu sistemskih kortikosteroidnih učinkov, vključno s Cushingovim sindromom in z zaviralnim vplivom na nadledvično žlezo.
The active substance is amprenavir The Agenerase oral solution contains 15 mg/ml of amprenavir.
Peroralna raztopina Agenerase vsebuje 15 mg/ml amprenavirja.
NAME OF THE MEDICINAL PRODUCT Agenerase 150 mg soft capsules.
IME ZDRAVILA Agenerase 150 mg mehke kapsule
In vivo a) ART-naïve or PI-naïve patients
In vivo a) Bolniki, ki se še niso zdravili s protiretrovirusnimi zdravili ali z zaviralci proteaz; neokrepljen amprenavir/fosamprenavir
MARKETING AUTHORISATION NUMBER(S) EU/1/00/148/001
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/148/001
Increased CPK, myalgia, myositis, and rarely rhabdomyolysis have been reported with protease inhibitors, particularly in combination with nucleoside analogues.
V povezavi z zaviralci proteaz, zlasti v kombinaciji z nukleozidnimi analogi, so poročali o zvišanih vrednostih CPK (kreatin-fosfokinaze), mialgiji, miozitisu in redkeje o rabdomiolizi.
The HMG-CoA reductase inhibitors lovastatin and simvastatin are highly dependent on CYP3A4 for metabolism, thus concomitant use of Agenerase with simvastatin or lovastatin is not recommended due to an increased risk of myopathy, including rhabdomyolysis.
Zaradi zvečanega tveganja za miopatije, vključno z rabdomiolizo, se sočasna uporaba zdravila Agenerase s simvastatinom ali z lovastatinom ne priporoča.
isolates), darunavir/ritonavir (four of 25 isolates), indinavir/ritonavir (one of 25 isolates), lopinavir/ritonavir (three of 24 isolates), saquinavir (three of 24 isolates) and tipranavir/ritonavir (four of 24 isolates).. Conversely amprenavir retains activity against some isolates with resistance to other PIs and this retained activity would depend on the number and type of protease resistance mutations present in the isolates
Na osnovi podatkov, pridobljenih pri petindvajsetih bolnikih, ki predhodno še niso bili zdravljeni s protiretrovirusnimi zdravili in pri katerih je bilo zdravljenje z režimom, ki je vključeval fosamprenavir, neuspešno (pri enem od njih je bila v izhodišču prisotna odpornost na lopinavir in sakvinavir, pri enem pa na tipranavir), mehanizem rezistence, povezan z amprenavirjem, povzroča omejeno navzkrižno rezistenco na atazanavir/ritonavir (trije od 25 izolatov), darunavir/ritonavir (štirje od 25 izolatov), indinavir/ritonavir (eden od 25 izolatov), lopinavir/ritonavir (trije od 24 izolatov), sakvinavir (trije od 24 izolatov) in tipranavir/ritonavir (štirje od 24 izolatov).
The use of amprenavir in combination with ritonavir has not been studied in patients with hepatic impairment.
Pri bolnikih z oslabljenim delovanjem jeter uporaba amprenavirja v kombinaciji z ritonavirjem ni bila raziskana.
Lipid disorders should be managed as clinically appropriate (see section 4.8).
Motnje lipidov je potrebno klinično ustrezno zdraviti.
NAME OF THE MEDICINAL PRODUCT Agenerase 50 mg soft capsules.
IME ZDRAVILA Agenerase 50 mg mehke kapsule
There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in haemophiliac patients type A and B treated with protease inhibitors.
Pri bolnikih s hemofilijo A in B, ki so se zdravili z zaviralci proteaz, so poročali o pogostnejših krvavitvah, vključno s spontanimi kožnimi hematomi in hemartrozami.
No dose recommendations can be given for the co-administration of amprenavir and delavirdine.
Za sočasno uporabo amprenavirja in delavirdina ne moremo podati priporočenih odmerkov.
• Diarrhoea, feeling sick, vomiting, flatulence
• Driska, slabost, bruhanje, flatulenca (nabiranje plinov v želodcu ali črevesju).
Tell your doctor if you have any of these listed conditions, or are taking any of the medicines listed above.
Če imate katero koli zgoraj navedeno bolezen ali se zdravite s katerim koli zgoraj navedenim zdravilom, to povejte svojemu zdravniku.