natgillin/translations-raw huggingface dataset:
Children 1 through 5 years of age: take 2.5 ml (½ of a 5 ml spoonful) of oral solution once a day.
Otroci, stari od 1 do 5 let: jemljite 2, 5 ml (pol polne 5 ml žličke) peroralne raztopine enkrat na dan.
Children 6 through 11 years of age: take 5 ml (one 5 ml spoonful) of oral solution once a day.
Otroci, stari od 6 do 11 let: jemljite 5 ml (eno polno 5 ml žličko) peroralne raztopine enkrat na dan.
Adults and adolescents (12 years of age and older): take 10 ml (two 5 ml spoonfuls) of oral solution once a day.
Odrasli in mladostniki (12 let ali več): jemljite 10 ml (dve 5 ml žlički) peroralne raztopine enkrat na dan.
Swallow the dose of oral solution, then drink some water.
Pogoltnite odmerek peroralne raztopine in potem popijte malo vode.
Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Aerius oral solution.
Kar zadeva trajanje zdravljenja, bo vaš zdravnik najprej ugotovil vrsto alergijskega rinitisa, ki jo imate, in na podlagi tega določil, kako dolgo naj bi jemali zdravilo Aerius peroralna raztopina..
If you take more Aerius than you should Take Aerius oral solution only as it is prescribed for you.
Če ste vzeli večji odmerek zdravila Aerius, kot bi smeli Zdravilo Aerius peroralna raztopina jemljite le tako, kot vam je bilo predpisano.
However, if you take more Aerius oral solution than you were told to, contact your doctor or pharmacist.
Pri naključnem prevelikem odmeranju zdravila ni pričakovati resnejših težav, kljub temu pa se v primeru, da ste zaužili več zdravila Aerius peroralna raztopina, kot bi morali, posvetujte s svojim zdravnikom ali farmacevtom.
Like all medicines, Aerius oral solution can cause side effects, although not everybody gets them.
91 Kot vsa zdravila ima lahko tudi zdravilo Aerius peroralna raztopina neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Tell your pharmacist if you notice any change in the appearance of the oral solution.
Obvestite svojega farmacevta, če opazite kakršnekoli spremembe v videzu peroralne raztopine.
- The other ingredients of the oral solution are sorbitol, propylene glycol, sucralose E 955,
- Pomožne snovi v peroralni raztopini so sorbitol, propilenglikol, sukraloza E 955, hipromeloza
hypromellose 2910, sodium citrate dihydrate, natural and artificial flavour (bubblegum), citric acid anhydrous, disodium edetate and purified water.
2910, natrijev citrat dihidrat, naravna in umetna aroma (žvečilni gumi), brezvodna citronska kislina, dinatrijev edetat in prečiščena voda.
95 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
92 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Ireland Shire Park Welwyn Garden City Hertfordshire AL7 1TW
Ireland Shire Park Welwyn Garden City Hertfordshire AL7 1TW
96 Tel: +44-(0)1 707 363 636
93 Tel: +44 - (0) 1 707 363 636
EMEA/ 306731/ 2008
EMEA/ 545129/ 2008
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for AFLUNOV Common name:
VPRAŠANJA IN ODGOVORI V ZVEZI Z UMIKOM VLOGE ZA DOVOLJENJE ZA PROMET Z ZDRAVILOM AFLUNOV
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) (A/ VietNam/ 1194/ 2004)
Cepivo za predpandemično influenco (H5N1) (površinski antigen, inaktiviran, adjuvant) (A/ VietNam/ 1194/ 2004)
On 13 June 2008, Novartis Vaccines and Diagnostics S. r. l. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Aflunov, for the prophylaxis of H5N1 avian influenza in adults and the elderly.
Družba Novartis Vaccines and Diagnostics S. r. l. je dne 13. junija 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Aflunov, namenjenemu zaščiti pred virusom aviarne influence H5N1, pri odraslih in starejših.
It consists of a suspension for injection that contains some parts (outer membranes) of the influenza (flu) virus strain called A/ VietNam/ 1194/ 2004.
Sestavljeno je iz suspenzije za injiciranje, ki vsebuje nekatere dele (zunanje membrane) seva virusa influence (gripa), imenovanega A/ VietNam/ 1194/ 2004.
Aflunov is a ‘ prepandemic’ vaccine.
Zdravilo Aflunov je „ predpandemično “ cepivo.
A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it.
Pandemija gripe nastopi, kadar se pojavi nov sev virusa gripe, ki se zlahka širi med ljudmi, saj posamezniki pred njim niso imuni (nimajo zaščite).
A pandemic can affect most countries and regions around the world.
Pandemija lahko prizadene večino držav in regij sveta.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against a disease.
Cepiva delujejo tako, da imunski sistem (naravni obrambni sistem telesa) „ naučijo “, kako se zaščiti pred boleznijo.
When a person is given the vaccine, the immune system recognises the parts of the flu virus it contains as ‘ foreign’ and makes antibodies against them.
Kadar posameznik prejme cepivo, imunski sistem prepozna dele virusa, ki ga le- to vsebuje, kot tuje in proti njim pripravi protitelesa.
Then, the outer membranes that contain the ‘ surface antigens’ (proteins on the outer membrane of the virus that the body recognises as foreign) were extracted and purified before being included in the vaccine.
Nato so bile zunanje membrane, ki vsebujejo površinske antigene (beljakovine na zunanji membrani virusa, ki ga telo prepoznava kot tujek), izločene in prečiščene, preden so bile ponovno dodane v cepivo.
Aflunov also contains an ‘ adjuvant’ (a compound containing oil), which is expected to stimulate a better response.
Aflunov vsebuje tudi adjuvant (sestavino, ki vsebuje olje), ki naj bi spodbujalo boljšo odzivnost.
It compared Aflunov’ s safety and its ability to stimulate the production of antibodies (‘ immunogenicity’) with those of a similar vaccine against seasonal flu.
Študija je primerjala varnost zdravila Aflunov in njegovo zmožnost za spodbujanje proizvodnje protiteles (imunogenost), v primerjavi s podobnimi cepivi proti sezonskim virusom gripe.
Based on the review of the data and the company’ s response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Aflunov could not have been approved for the prophylaxis of H5N1 avian influenza.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila Aflunov ni mogoče odobriti za zaščito pred virusom H5N1 aviarne influence.
An inspection of some of the study sites showed that the study had not been conducted in compliance with ‘ good clinical practice’ (GCP).
Pregled nekaterih točk študije je namreč razkril, da študija ni bila izvedena v skladu z dobro klinično prakso.
As a result, the size of the clinical database for the assessment of the vaccine’ s safety was not sufficient to fulfil the requirements of the EMEA’ s guidelines on prepandemic vaccines.
Tako velikost klinične podatkovne baze za ocenjevanje varnosti cepiva ni bila zadostna za izpolnitev določil smernic agencije EMEA o predpandemičnih cepivih.
Route of administration
Farmacevtska oblika Način uporabe
bottle (HDPE)
Peroralna uporaba Plastenka (HDPE)
bottle (HDPE)
Peroralna raztopina
240 ml (15 mg/ ml)
Peroralna uporaba Plastenka (HDPE) 240 ml (15 mg/ ml)
It is available as cream capsules (50 and 150 mg) and as an oral solution (15 mg/ ml).
Zdravilo je na voljo v obliki kapsul krem barve (50 in 150 mg) in v obliki peroralne raztopine (15 mg/ ml).
Agenerase is an antiviral medicine.
Zdravilo Agenerase je protivirusno zdravilo.
It is used in combination with other antiviral medicines to treat adults and children over four years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Uporablja se v kombinaciji z drugimi protivirusnimi zdravili za zdravljenje odraslih in otrok, starejših od štirih let, ki so okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV- 1), ki povzroča sindrom pridobljene imunske pomanjkljivosti (AIDS).
Although Agenerase oral solution is available for patients who cannot swallow the capsules, it cannot be given with ritonavir because the safety of this combination has not been assessed.
Čeprav je bolnikom, ki ne morejo pogoltniti kapsul, na voljo peroralna raztopina, pa se slednja ne sme jemati skupaj z ritonavirjem, ker varnost te kombinacije še ni bila ocenjena.
The recommended dose for patients over 12 years of age is 600 mg twice a day, taken with 100 mg ritonavir twice a day and with other antiviral medicines.
Priporočeni odmerek za bolnike, starejše od 12 let, je 600 mg dvakrat na dan skupaj s 100 mg ritonavirja dvakrat na dan in drugimi protivirusnimi zdravili.
In children aged between four and 12 years and in patients who weigh less than 50 kg, the recommended dose of Agenerase depends on body weight.
Pri otrocih, starih od štiri do 12 let, in bolnikih, ki tehtajo manj kot 50 kg, je velikost priporočenega odmerka zdravila Agenerase odvisna od telesne mase bolnika.
Agenerase can be taken with or without food.
Bolnik lahko vzame zdravilo Agenerase s hrano ali brez nje.
Because amprenavir is less easily absorbed with the oral solution than with the capsules, the two formulations are not interchangeable on a milligram-by-milligram basis.
Ker se amprenavir v obliki peroralne raztopine po zaužitju ne absorbira tako lahko kot amprenavir v obliki kapsul, ti obliki zdravila nista medsebojno zamenljivi po načelu „ miligram za miligram “.
It blocks an enzyme called protease, which is involved in the reproduction of HIV.
Ta blokira encim, imenovan proteaza, ki sodeluje pri razmnoževanju virusa HIV.
Ritonavir is another protease inhibitor that is used as a ‘ booster’.
Ritonavir je drug zaviralec proteaze, ki se uporablja kot „ okrepitev “.
It slows down the rate at which amprenavir is broken down, increasing the levels of amprenavir in the blood.
Učinkuje tako, da upočasni hitrost presnove amprenavirja in s tem poviša ravni amprenavirja v krvi.
This allows a lower dose of amprenavir to be used for the same effect.
Zaradi tega lahko uporabimo manjši odmerek amprenavirja za enak protivirusni učinek.
Agenerase does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo Agenerase ne zdravi okužbe z virusom HIV ali AIDS- a, lahko pa podaljša čas do pojava poškodbe imunskega sistema ter razvoja okužb in bolezni, ki so povezane z AIDS- om.
Agenerase, in combination with other antiviral medicines but without ritonavir, has been studied in two main studies including 736 HIV-infected adults who had not previously been treated with protease inhibitors.
Zdravilo Agenerase v kombinaciji z drugimi protivirusnimi zdravili vendar brez ritonavirja so proučevali v dveh glavnih študijah, ki sta vključevali 736 odraslih bolnikov, okuženih z virusom HIV, ki se pred tem še niso zdravili z zaviralci proteaz.
In these studies, Agenerase was compared with placebo (a dummy treatment) and with invirase (another protease inhibitor).
V teh študijah so zdravilo Agenerase primerjali s placebom (zdravilom brez zdravilne učinkovine) ali invirazo (drugim zaviralcem proteaze).
Agenerase has also been studied in 268 HIV-infected children aged between six months and 18 years.
Zdravilo Agenerase so raziskali tudi pri 268 otrocih, okuženih z virusom HIV, ki so bili stari od šest mesecev do 18 let.
All of the children had previously taken treatment for HIV infection, and 135 of them had been treated with protease inhibitors.
Vsi otroci so se že predhodno zdravili zaradi okužbe z virusom HIV, 135 od vseh otrok pa je pred tem že prejemalo tudi zaviralce proteaz.
Agenerase boosted with low-dose ritonavir has been compared with other protease inhibitors in 206 adults who had taken protease inhibitors in the past.
Pri 206 odraslih, ki so v preteklosti že prejemali zaviralce proteaz, so učinkovitost okrepljenega zdravila Agenerase v kombinaciji z nizkimi odmerki ritonavirja primerjali tudi z učinkovitostjo drugih zaviralcev proteaz.
Of these, 43 had HIV that was resistant to four other protease inhibitors.
Med temi bolniki jih je bilo 43 okuženih z virusom HIV, ki je bil odporen na štiri druge zaviralce proteaz.
The main measures of effectiveness were the proportion of patients with undetectable levels of HIV in the blood (viral load) or the change in viral load after treatment.
Glavno merilo učinkovitosti je bil delež bolnikov z nezaznavno ravnjo virusa HIV v krvi (virusno obremenitvijo) ali sprememba virusne obremenitve po zdravljenju.
In the studies of patients who had not previously taken protease inhibitors, more patients taking Agenerase had viral loads below 400 copies/ ml than those taking placebo after 48 weeks, but Agenerase was less effective than indinavir.
V študijah z bolniki, ki se pred tem še niso zdravili z zaviralci proteaz, je imelo po 48 tednih virusno obremenitev pod 400 kopij/ ml večje število bolnikov, ki so jemali zdravilo Agenerase, kot tistih, ki so jemali placebo, vendar pa je bilo zdravilo Agenerase manj učinkovito kot indinavir.
Agenerase also reduced viral loads in children, although very few of the children who had taken protease inhibitors in the past responded to treatment.
Zdravilo Agenerase je pri otrocih prav tako znižalo virusno obremenitev, vendar se je na zdravljenje odzvalo zelo majhno število otrok, ki so v preteklosti že jemali zaviralce proteaz.
The studies included very few children aged below four years.
Študije so vključevale zelo majhno število otrok, mlajših od štirih let.
In the study of adults who had taken protease inhibitors in the past, Agenerase boosted with ritonavir was as effective as other protease inhibitors in reducing viral loads after 16 weeks of treatment: around two thirds of the patients in both groups had viral loads below 400 copies/ ml.
Študija pri odraslih, ki so v preteklosti jemali zaviralce proteaz, je pokazala, da je bila kombinacija zdravila Agenerase, okrepljenega z ritonavirjem, po 16 tednih zdravljenja enako učinkovita pri nižanju virusne obremenitve kot drugi zaviralci proteaz: okoli dve tretjini bolnikov v obeh skupinah je imelo virusno obremenitev pod 400 kopij/ ml.
In the patients with HIV that was resistant to four other protease inhibitors, patients taking Agenerase with ritonavir had a greater fall in viral load after four weeks than those continuing to take their previous protease inhibitors: half of those taking Agenerase with ritonavir had viral loads below 400 copies/ ml, compared with none of those continuing to take their previous protease inhibitors.
Pri bolnikih z virusom HIV, odpornim na štiri druge zaviralce proteaz, se je pri tistih, ki so jemali kombinacijo zdravila Agenerase in ritonavirja, po štirih tednih pokazalo večje znižanje virusne obremenitve kot pri tistih, ki so še naprej jemali zaviralce proteaz, ki so jih uporabljali pred tem: polovica bolnikov, ki so jemali kombinacijo zdravila Agenerase in ritonavirja, je imela virusno obremenitev pod 400 kopij/ ml v primerjavi z nobenim iz skupine tistih, ki so še naprej jemali zaviralce proteaz, ki so jih uporabljali pred tem.
The most common side effects with Agenerase (seen in more than 1 patient in 10) are headache, diarrhoea, flatulence (gas), nausea (feeling sick), vomiting, rash and fatigue (tiredness).
Najpogostejši neželeni učinki zdravila Agenerase (opaženi pri več 1 bolniku od 10) so glavobol, driska, flatulenca (vetrovi), slabost, bruhanje, izpuščaji in utrujenost.
For the full list of all side effects reported with Agenerase, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Agenerase, glejte navodilo za uporabo.
Agenerase should not be used in people who may be hypersensitive (allergic) to amprenavir or any of the other ingredients.
Zdravila Agenerase ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) amprenavir ali katero koli drugo sestavino zdravila.
Agenerase must not be used in patients who are taking St John’ s wort (a herbal preparation used to treat depression) or medicines that are broken down in the same way as Agenerase and are harmful at high levels in the blood.
Zdravila Agenerase ne smejo uporabljati bolniki, ki jemljejo šentjanževko (rastlinski pripravek za zdravljenje depresije) ali zdravila, ki se presnavljajo na enak način kot zdravilo Agenerase in so pri visokih ravneh v krvi škodljiva.
Agenerase boosted with ritonavir must not be taken by patients who have severe problems with their liver, or by patients taking rifampicin (used to treat tuberculosis) or medicines that are broken down in the same way as ritonavir, such as flecainide and propafenone (used to correct irregular heartbeat).
Zdravila Agenerase v kombinaciji z ritonavirjem, ki okrepi učinek zdravila, prav tako ne bi smeli uporabljati bolniki, ki imajo hude težave z jetri ali jemljejo rifampicin (zdravilo za zdravljenje tuberkuloze) oziroma zdravila, ki se presnavljajo na enak način kot ritonavir, kakršna sta flekainid in propafenon (zdravilo za uravnavanje nerednega srčnega ritma).
Caution is needed when Agenerase is taken at the same time as some other medicines.
2/ 3 Pri sočasnem jemanju zdravila Agenerase z nekaterimi drugimi zdravili je potrebna previdnost.
See the Package Leaflet for full details.
Za podrobnejše informacije glejte navodilo za uporabo.
2/ 3 Why has Agenerase been approved?
Zakaj je bilo zdravilo Agenerase odobreno?
The Committee for Medicinal Products for Human Use (CHMP) decided that Agenerase’ s benefits are greater than its risks for use in combination with other antiretroviral agents in the treatment of protease inhibitor experienced HIV-1 infected adults and children above the age of four years.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Agenerase večje od z njim povezanih tveganj pri njegovi uporabi v kombinaciji z drugimi protiretrovirusnimi sredstvi za zdravljenje odraslih bolnikov in otrok, starejših od štirih let, ki so okuženi s HIV- 1 in so se že zdravili z zaviralci proteaz.
It is normally taken with the pharmacokinetic enhancer ritonavir, but the Committee noted that the benefit of Agenerase taken with ritonavir has not been demonstrated in patients who have not taken protease inhibitors in the past.
Zdravilo se navadno jemlje skupaj z okrepitvijo, farmakokinetičnim ritonavirjem, vendar pa je Odbor ugotovil, da koristni učinki zdravila Agenerase v kombinaciji z ritonavirjem pri bolnikih, ki v preteklosti še niso jemali zaviralcev proteaz, niso bili dokazani.
Agenerase was originally authorised under ‘ Exceptional Circumstances’, because, for scientific reasons, limited information was available at the time of approval.
Zdravilo Agenerase je bilo prvotno odobreno „ v izjemnih okoliščinah “, ker podatki zaradi znanstvenih razlogov v času odobritve niso bili na razpolago.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 10 March 2004.
Ko je družba predložila dodatne zahtevane podatke, je odobritev „ v izjemnih okoliščinah “ prenehala veljati dne 10. marca 2004.
The marketing authorisation was renewed on 20 October 2005.
Dovoljenje za promet je bilo obnovljeno dne 20. oktobra 2005.
This summary was last updated in 11-2008.
Povzetek je bil nazadnje posodobljen 11- 2008.
Excipients: d-sorbitol (E420)
Pomožne snovi: d- sorbitol (E420)
Oblong, opaque, off-white to cream coloured, printed with ‘ GX CC1’.
Podolgovate, neprozorne, sivobele do krem barve, z oznako ‘ GX CC1 ’.
Agenerase, in combination with other antiretroviral agents, is indicated for the treatment of protease inhibitor (PI) experienced HIV-1 infected adults and children above the age of 4 years.
Zdravilo Agenerase je, v kombinaciji z drugimi protiretrovirusnimi zdravili, indicirano za zdravljenje odraslih in otrok, starejših od 4 let, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV- 1) in so predhodno že bili zdravljeni z zaviralcem proteaz (PI- jem).
Agenerase capsules should normally be administered with low dose ritonavir as a pharmacokinetic enhancer of amprenavir (see sections 4.2 and 4.5).
Kapsule Agenerase se morajo praviloma dajati skupaj z nizkim odmerkom ritonavirja, ki stopnjuje farmakokinetične lastnosti amprenavirja (glejte poglavji 4. 2 in 4. 5).
The choice of amprenavir should be based on individual viral resistance testing and treatment history of patients (see section 5.1).
Izbira amprenavirja mora temeljiti na individualnem testiranju virusne rezistence in podatkih predhodnega zdravljenja bolnikov (glejte poglavje 5. 1).
The benefit of Agenerase boosted with ritonavir has not been demonstrated in PI naïve patients (see section 5.1)
Pri bolnikih, ki še niso bili zdravljeni s PI- jem, korist okrepitve učinka zdravila Agenerase z ritonavirjem ni bila dokazana (glejte poglavje 5. 1).
Amprenavir is 14% less bioavailable from the oral solution than from the capsules; therefore, Agenerase capsules and Agenerase oral solution are not interchangeable on a milligram per milligram basis (see section 5.2).
Biološka uporabnost amprenavirja v peroralni raztopini je za 14% manjša kot v kapsulah, zato kapsule Agenerase in peroralna raztopina Agenerase niso zamenljive v enakih miligramskih odmerkih (glejte poglavje 5. 2).
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.
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.
2 Children (4 to 12 years) and patients less than 50 kg body weight: the recommended dose of Agenerase capsules is 20 mg/ kg body weight twice a day, in combination with other antiretroviral agents, without exceeding a total daily dose of 2400 mg (see section 5.1).
V kombinaciji z drugimi protiretrovirusnimi zdravili je priporočen odmerek kapsul Agenerase 20 mg/ kg telesne mase dvakrat dnevno, skupni dnevni odmerek pa ne sme presegati 2400 mg (glejte poglavje 5. 1).
Therefore, such combinations should be avoided in children.
Farmakokinetične lastnosti, učinkovitost in varnost zdravila Agenerase v kombinaciji z nizkimi odmerki ritonavirja ali drugimi zaviralci proteaz pri otrocih še niso bile ovrednotene, zato se je takšnim kombinacijam pri otrocih potrebno izogibati.
Children less than 4 years of age:
Otroci, mlajši od 4 let:
Agenerase is not recommended in children below 4 years due to lack of data on safety and efficacy (see section 5.2).
Zaradi pomanjkanja podatkov o varnosti in učinkovitosti, uporabe zdravila Agenerase pri otrocih, mlajših od 4 let, ne priporočamo (glejte poglavje 5. 2).
Elderly: the pharmacokinetics, efficacy and safety of amprenavir have not been studied in patients over 65 years of age (see section 5.2).
Farmakokinetične lastnosti, učinkovitost in varnost amprenavirja pri bolnikih, starejših od 65 let, niso bile raziskane (glejte poglavje 5. 2).
Renal impairment: no dose adjustment is considered necessary in patients with renal impairment (see section 5.2).
Pri bolnikih z oslabljenim delovanjem ledvic odmerka ni potrebno prilagoditi (glejte poglavje 5. 2).
Hepatic impairment: the principal route of metabolism of amprenavir is via the liver.
Glavna pot presnove amprenavirja poteka preko jeter.
No dose recommendation can be made in children with hepatic impairment (see section 5.2).
Za otroke z oslabljenim delovanjem jeter ne moremo podati priporočenega odmerka (glejte poglavje 5. 2).
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).
4. 3 Kontraindikacije