natgillin/translations-raw huggingface dataset:
The other ingredients are: glycerol (E422), carmellose sodium, sorbitol liquid (crystallizing) (E420), polyethylene glycol 4000, sodium chloride, citric acid (anhydrous), acesulfame potassium (E950), sodium propylparahydroxybenzoate (E217), sodium methylparahydroxybenzoate (E219), strawberry flavour (contains propylene glycol, maltol), masking flavour (contains propylene glycol, aspartame (E951), acesulfame potassium (E950), maltol, deionised water), purified water.
Pomožne snovi so: glicerol (E422), natrijev karmelozat, sorbitol, tekoči (kristalizirajoči) (E420), polietilenglikol 4000, natrijev klorid, citronska kislina (brezvodna), kalijev acesulfamat (E950), natrijev propilparahidroksibenzoat (E217), natrijev metilparahidroksibenzoat (E219), okus jagode (vsebuje propilenglikol, maltol), prekrivni okus (vsebuje propilenglikol, aspartam (E951), kalijev acesulfamat (E950), maltol, deionizirano vodo), prečiščena voda.
What Vimpat looks like and contents of the pack Vimpat 15 mg/ml syrup is a clear solution, slightly yellow to yellow-brown in colour.
Izgled zdravila Vimpat in vsebina pakiranja Zdravilo Vimpat 15 mg/ ml sirup je bistra raztopina, rahlo rumene do rumeno- rjave barve.
Vimpat is available in bottles of 200 ml and 465 ml.
Zdravilo Vimpat je na voljo v stekleničkah po 200 ml in 465 ml.
Luxembourg/Luxemburg UCB Pharma SA/NV Tél/ Tel: +32 / (0)2 559 92 00
Magyarország България UCB Magyarország Kft.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA)
120 PACKAGE LEAFLET:
120 http: // www. emea. europa. eu /
INFORMATION FOR THE USER
121 NAVODILO ZA UPORABO
Vimpat 10 mg/ml solution for infusion Lacosamide
Vimpat 10 mg/ ml raztopina za infundiranje lakozamid
Read all of this leaflet carefully before you start using this medicine. • Keep this leaflet.
Pred začetkom jemanja natančno preberite navodilo! • Navodilo shranite.
Before you use Vimpat 3.
Kaj morate vedeti, preden boste vzeli zdravilo Vimpat 3.
How to use Vimpat 4.
Kako jemati zdravilo Vimpat 4.
Vimpat solution for infusion is an alternative form of treatment for a short period of time, when oral (by mouth) administration is not possible.
Raztopina za infundiranje Vimpat je alternativna oblika kratkotrajnega zdravljanja, kadar peroralno (skozi usta) jemanje zdravila ni mogoče.
BEFORE YOU USE VIMPAT
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO VIMPAT
121 A small number of people being treated with anti-epileptics such as lacosamide have had thoughts of harming or killing themselves.
Pri majhnem številu bolnikov, ki so se zdravili z antiepileptiki kot je lakozamid, so se pojavile misli na 122 samopoškodovanje ali samomor.
Using Vimpat with food and drink You may take Vimpat with or without food.
Jemanje zdravila Vimpat skupaj s hrano in pijačo Zdravilo Vimpat lahko vzamete s hrano ali brez nje.
To be taken into consideration for patients on a controlled sodium diet.
Pomembne informacije o nekaterih sestavinah zdravila Vimpat Zdravilo vsebuje 2, 6 mmol (ali 59, 8 mg) natrija na vialo, kar je treba upoštevati pri bolnikih, ki so na dieti z nadzorovanim vnosom natrija.
HOW TO USE VIMPAT
KAKO UPOPRABLJATI ZDRAVILO VIMPAT
It will be admin istered into a vein by a health care professional.
Zdravilo vam bo zdravstveno osebje dalo v obliki infuzije v veno.
Dosage Vimpat must be administered twice a day, once in the morning and once in the evening, at about the same time each day.
Odmerjanje Zdravilo Vimpat morate prejeti dvakrat na dan, enkrat zjutraj in enkrat zvečer, vsak dan ob približno enakem času.
How Vimpat is given to you Vimpat is administered as an infusion into a vein (intravenously) by a healthcare professional.
Infundiranje bo trajalo
It is infused over 15-60 minutes.
123 15 - 60 minut.
122 Duration of the treatment with Vimpat solution for infusion Your doctor will decide for how many days you will receive the infusions.
Trajanje zdravljenja z zdravilom Vimpat raztopina za infundiranje Zdravnik bo določil, koliko dni boste prejemali infuzijo.
If you stop using Vimpat If your doctor decides to stop your treatment with Vimpat, he/she will decrease the dose step by step.
Če ste prenehali jemati zdravilo Vimpat Če se bo zdravnik odločil prekiniti vaše zdravljenje z zdravilom Vimpat, bo odmerek zmanjševal po korakih.
Do not use Vimpat after the expiry date which is stated on the carton and vial.
Zdravila Vimpat ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali.
Each vial of Vimpat solution for infusion must be used only once (single use).
Vsaka viala zdravila Vimpat 10 mg/ ml raztopina za infundiranje se lahko uporabi le enkrat (enkratna uporaba).
Medicines should not be disposed of via wastewater or household waste.
124 Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
1 ml Vimpat solution for infusion contains 10 mg lacosamide.
1 ml zdravila Vimpat 10 mg/ ml raztopina za infundiranje vsebuje 10 mg lakozamida.
1 vial contains 20 ml Vimpat solution for infusion equivalent to 200 mg lacosamide.
1 viala vsebuje 20 ml zdravila Vimpat 10 mg/ ml raztopina za infundiranje, kar ustreza 200 mg lakozamida.
What Vimpat looks like and contents of the pack Vimpat 10 mg/ml solution for infusion is a clear, colourless solution.
Izgled zdravila Vimpat in vsebina pakiranja Zdravilo Vimpat 10 mg/ ml raztopina za infundiranje je bistra, brezbarvna raztopina.
Vimpat solution for infusion is available in packages of 1 vial, containing 20 ml.
Zdravilo Vimpat 10 mg/ ml raztopina za infundiranje je na voljo v pakiranjih po 1 vialo, po 20 ml.
España UCB Pharma, S.A.
125 Portugal España UCB Pharma (Produtos Farmacêuticos), Lda UCB Pharma, S. A.
124 France UCB Pharma S.A.
România France UCB S. A.
Reprezentanţă Tel: + 40 (21) 300 29 04
Tel: + 40 (21) 300 29 04 Tél: + 33 / (0) 1 47 29 44 35
Vimpat solution for infusion can be administered without further dilution, or may be diluted with the following solutions:
Zdravilo boste lahko prejeli brez predhodnega redčenja ali pa bo zdravilo prej razredčeno z eno od naslednjih raztopin:
0.9% sodium chloride 9 mg/ml (0.9%), 5% glucose 50 mg/ml or lactated Ringer’s solution.
0, 9% raztopina natrijevega klorida 9 mg/ ml (0, 9%), 5% raztopina glukoze 50 mg/ ml ali raztopina Ringerjevega laktata.
125
126
It is available as an oral powder (50 mg per gram) and as blue, oblong tablets (250 mg).
Na voljo je v obliki peroralnega praška (50 mg na gram) in modrih, podolgovatih tablet (250 mg).
It is used in combination with other antiviral medicines to treat adults, adolescents and children over three years of age who are infected with human immunodeficiency virus (HIV-1), the virus that causes acquired immune deficiency syndrome (AIDS).
Uporablja se v kombinaciji z drugimi protivirusnimi zdravili za zdravljenje odraslih, mladostnikov in otrok, starejših od 3 let, ki so okuženi z virusom humane imunske pomanjkljivosti 1 (HIV- 1), ki povzroča sindrom pridobljene imunske pomanjkljivosti (AIDS).
For patients aged over 13 years, the recommended dose of Viracept is 1,250 mg twice a day or 750 mg three times a day, taken with food.
Za bolnike, ki so starejši od 13 let, znaša priporočeni odmerek zdravila Viracept 1250 mg dvakrat na dan ali 750 mg trikrat na dan s hrano.
The oral powder can be used in patients who are unable to swallow capsules.
Peroralni prašek je namenjen bolnikom, ki ne morejo pogoltniti kapsul.
The appropriate amount of powder is measured using the special scoops supplied in the pack, and the powder mixed with milk or formula.
Ustrezno količino praška odmerimo s posebnimi mericami, ki so priložene zdravilu, ter jo zmešamo z mlekom ali formulo.
It blocks an enzyme called protease that is involved in the reproduction of HIV.
Ta blokira encim, imenovan proteaza, ki sodeluje pri razmnoževanju virusa HIV.
Viracept 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 Viracept ne zdravi okužbe z virusom HIV ali AIDS- a, lahko pa podaljša čas do pojava okvar imunskega sistema ter razvoja okužb in bolezni, ki so povezane z AIDS- om.
The main measures of effectiveness were the change in the levels of HIV in the blood (viral load) and the change in the number of CD4 T-cells in the blood (CD4 cell count).
Glavni merili učinkovitosti sta bili sprememba ravni virusa HIV (virusne obremenitve) v krvi in sprememba števila T- celic CD4 v krvi.
CD4 T-cells are white blood cells that are important in helping to fight infections, but which are killed by HIV.
T- celice CD4 so bele krvničke, ki so pomembne za obrambo pred okužbami, vendar pa jih virus HIV ubija.
After 24 weeks, Viracept brought about greater reductions in viral loads and increases in CD4 cell counts than the comparator medicines.
Po 24 tednih je zdravilo Viracept bolj znižalo virusno obremenitvev in povečalo število celic CD4 kot primerjalna zdravila.
In the second study, viral loads had fallen by more than 99% in the patients taking the higher dose of Viracept, compared with 95% in those taking the comparator medicines.
V drugi študiji se je virusna obremenitev bolnikov, ki so jemali višje odmerke zdravila Viracept, znižala za več kot 99%, v primerjavi s 95% pri tistih, ki so jemali primerjalna zdravila.
CD4 cell counts increased by 150 and 95 cells/ mm3, respectively.
Pri obeh skupinah bolnikov se je povečalo tudi število celic CD4, in sicer za 150 oziroma 95 celic/ mm3.
For the full list of all side effects seen with Viracept, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Viracept, glejte navodilo za uporabo.
Viracept should not be used in people who may be hypersensitive (allergic) to nelfinavir or any of the other ingredients.
Zdravila Viracept ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) nelfinavir ali katero koli drugo sestavino zdravila.
Viracept should not be used in patients who are taking any of the following medicines: • rifampicin (used to treat tuberculosis); • St John’ s wort (a herbal preparation used to treat depression); • omeprazole (used to reduce stomach acid levels); • medicines that are broken down in the same way as Viracept and are harmful at high levels in the blood.
Zdravilo Viracept se ne sme uporabljati pri bolnikih, ki jemljejo katero koli izmed naslednjih zdravil: • rifampicin (zdravilo za zdravljenje tuberkuloze), • šentjanževko (rastlinski pripravek za zdravljenje depresije), • omeprazol (uporablja se za znižanje ravni želodčne kisline), • zdravila, ki se presnavljajo na enak način kot zdravilo Viracept in so pri visokih ravneh v krvi škodljiva.
As with other anti-HIV medicines, patients taking Viracept may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Enako kot pri drugih zdravilih proti HIV lahko pride tudi pri bolnikih, ki jemljejo zdravilo Viracept, do lipodistrofije (spremembe v porazdelitvi telesnega maščevja), osteonekroze (odmiranja kostnega tkiva) ali sindroma imunske reaktivacije (simptomov okužbe, ki jih povzroči imunski sistem med okrevanjem).
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Viracept.
Pri bolnikih s težavami z jetri (vključno z okužbo s hepatitisom B ali C) obstaja pri jemanju zdravila Viracept povečano tveganje za poškodbe jeter.
The Committee for Medicinal Products for Human Use (CHMP) decided that Viracept’ s benefits are greater than its risks in antiretroviral combination treatment of HIV-1 infected adults, adolescents and children of three years of age and older.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Viracept pri kombiniranem protiretrovirusnem zdravljenju odraslih, mladostnikov in otrok, starih 3 leta ali več, okuženih z virusom HIV, večje od z njim povezanih tveganj.
The Committee recommended that Viracept be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Viracept odobri dovoljenje za promet.
Viracept was originally authorised under ‘ Exceptional Circumstances’, because, for scientific reasons, limited information was available at the time of approval.
Zdravilo Viracept 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 1 August 2001.
Ko je družba predložila dodatne zahtevane podatke, je odobritev „ v izjemnih okoliščinah “ prenehala veljati 1. avgusta 2001.
2/ 3 Other information about Viracept:
2/ 3 Druge informacije o zdravilu Viracept:
The European Commission granted a marketing authorisation valid throughout the European Union for Viracept to Roche Registration Limited on 22 January 1998.
Evropska komisija je dovoljenje za promet z zdravilom Viracept, veljavno po vsej Evropski uniji, odobrila družbi Roche Registration Limited dne 22. januarja 1998.
The marketing authorisation was renewed on 22 January 2003 and on 22 January 2008.
Dovoljenje za promet je bilo obnovljeno dne 22. januarja 2003 in 22. januarja 2008.
The full EPAR for Viracept can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Viracept je na voljo tukaj.
EU/ 1/ 97/ 054/ 001
Številka EU EU/ 1/ 97/ 054/ 001
Viracept
Izmišljeno ime Viracept
50 mg/ g
jakost 50 mg/ g
Oral powder
pot uporabe peroralna uporaba
Oral use
ovojnina steklenica (HDPE)
bottle (HDPE) 144 g
vsebina 144 g
1 bottle + 1 g and 5 g polypropylene scoop
velikost pakiranja 1 steklenica + 1- g in 5- g polipropilenska merica
Film-coated tablet Film-coated tablet
filmsko obložene tablete
bottle (HDPE) bottle (HDPE)
steklenica (HDPE)
VIRACEPT 50 mg/ g oral powder.
VIRACEPT 50 mg/ g peroralni prašek
- Contains sucrose palmitate:
- vsebuje saharozo palmitat:
10.0 mg per gram of oral powder.
10, 0 mg na gram peroralnega praška.
10.0 mg of sucrose palmitate,
10, 0 mg saharoze palmitat, ki
which is an ester, theoretically corresponds to maximally 5.9 mg of sucrose when fully hydrolysed.
je ester, teoretično ustreza največ 5, 9 mg saharoze, ko je popolnoma hidrolizirana.
- Contains aspartame (E951):
- vsebuje aspartam (E951):
20.0 mg of aspartame per gram of oral powder.
20, 0 mg aspartama na gram peroralnega praška.
- Contains potassium:
- vsebuje kalij:
50.0 mg of dibasic potassium phosphate corresponding to 22.5 mg of
50, 0 mg kalijevega hidrogenfosfata ustreza 22, 5 mg kalija na gram peroralnega
potassium per gram of oral powder.
praška.
VIRACEPT is indicated in antiretroviral combination treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children of 3 years of age and older.
Zdravilo VIRACEPT je indicirano za kombinirano protiretrovirusno zdravljenje odraslih, mladostnikov in otrok, starih tri leta ali več, ki so okuženi z virusom humane imunske pomanjkljivosti (HIV- 1).
In protease inhibitor (PI) experienced patients the choice of nelfinavir should be based on individual viral resistance testing and treatment history.
Izbira nelfinavirja pri bolnikih, že zdravljenih z zaviralci proteaz (PI – “ protease inhibitor ”), mora biti osnovana na testiranju virusne odpornosti posameznika in predhodnega zdravljenja.
VIRACEPT should always be ingested with food (see section 5.2).
Zdravilo VIRACEPT je treba vedno jemati skupaj s hrano (glejte poglavje 5. 2).
VIRACEPT 250 mg tablets are recommended for adults and older children (see Summary of Product Characteristics for VIRACEPT 250 mg tablets).
Bolniki, starejši od 13 let: tablete VIRACEPT 250 mg so priporočljive za odrasle in starejše otroke (glejte Povzetek glavnih značilnosti za tablete VIRACEPT 250 mg).
The recommended dose of VIRACEPT 50 mg/ g oral powder is 1250 mg twice a day (BID) or 750 mg three times a day (TID), for patients unable to take tablets.
Priporočeni odmerek peroralnega praška VIRACEPT 50 mg/ g za bolnike, ki niso zmožni jemati tablet, je 1. 250 mg dvakrat na dan ali 750 mg trikrat na dan.
All patients older than 13 years should take either 5 level scoops of the blue 5 gram spoon twice daily or 3 level scoops of the blue 5 gram spoon three times daily.
Vsi bolniki, starejši od 13 let, morajo vzeti ali 5 poravnanih modrih 5- g meric dvakrat na dan ali 3 poravnane modre 5- g merice praška trikrat na dan.
The efficacy of the BID (twice daily) regimen has been evaluated versus the TID (three times daily) regimen primarily in patients naïve to PIs (see section 5.1)
Učinkovitost odmerjanja dvakrat na dan v primerjavi z odmerjanjem trikrat na dan so proučevali v glavnem pri bolnikih, ki se še niso zdravili s PI (glejte poglavje 5. 1).
Patients aged 3 to 13 years: for children, the recommended starting dose is 50-55 mg/ kg BID or if using a TID regimen, 25 – 30 mg/ kg body weight per dose.
Bolniki, stari 3 do 13 let: za otroke je priporočeni začetni odmerek 50 do 55 mg/ kg telesne mase dvakrat na dan ali 25 do 30 mg/ kg telesne mase trikrat na dan.
For children able to take tablets,
Otroci, ki lahko jemljejo tablete,
2 VIRACEPT tablets may be administered instead of the oral powder (see Summary of Product Characteristics for VIRACEPT tablets).
2 lahko namesto praška zaužijejo VIRACEPT tablete 250 mg (glejte Povzetek glavnih značilnosti za tablete VIRACEPT).
The recommended dose of VIRACEPT oral powder to be administered BID to children aged 3 to 13 years, using a combination of both the white 1 gram and the blue 5 gram scoop is shown in the following table.
Priporočeni odmerek peroralnega praška VIRACEPT za otroke, stare od 3 do 13 let, pri odmerjanju dvakrat na dan z uporabo kombinacije bele 1- g in modre 5- g merice je prikazan v spodnji preglednici.
Dose to be administered two times a day to children aged 3 to 13
Odmerek za dajanje 2- krat na dan otrokom starim od 3 do 13 let
Body Weight of the patient
bolnikova telesna masa
Blue Scoop 5 gram
modra merica 5 gramov
White Scoop 1 gram
bela merica 1 gram
Total grams of Powder per dose
skupno gramov praška na odmerek
7.5 to 8.5 kg 8.5 to 10.5 kg
7, 5 do 8, 5 kg 8, 5 do 10, 5 kg
10.5 to 12 kg 12 to 14 kg 14 to 16 kg 16 to 18 kg 18 to 22 kg over 22 kg
10, 5 do 12 kg 12 do 14 kg 14 do 16 kg 16 do 18 kg 18 do 22 kg nad 22 kg
The recommended dose of VIRACEPT oral powder to be administered TID to children aged 3 to 13 years, using a combination of both the white 1 gram and the blue 5 gram scoop is shown in the following table.
Priporočeni odmerek peroralnega praška VIRACEPT za otroke, stare od 3 do 13 let, pri odmerjanju trikrat na dan z uporabo kombinacije bele 1- g in modre 5- g merice je prikazan v spodnji preglednici.
Dose to be administered three times a day to children aged 3 to 13
Odmerek za dajanje 3- krat na dan otrokom starim od 3 do 13 let
10.5 to 12 kg 12 to 14 kg 14 to 16 kg 16 to 18 kg 18 to 23 kg over 23 kg
10, 5 do 12 kg 12 do 14 kg 14 do 16 kg 16 do 18 kg 18 do 23 kg nad 23 kg
The oral powder may be mixed with water, milk, formula, soy formula, soy milk, dietary supplements, or pudding.
Peroralni prašek VIRACEPT 50 mg/ g lahko mešamo z vodo, mlekom, nadaljevalnimi formulami za majhne otroke, nadaljevalnimi formulami za majhne otroke, izdelanih iz izolatov beljakovin iz soje, sojinim mlekom, dietnimi dodatki ali pudingom.
It is recommended that VIRACEPT 50 mg/ g oral powder mixed in these media be used within 6 hours.
Priporočljivo je, da se že zmešan peroralni prašek VIRACEPT 50 mg/ g uporabi v šestih urah.
Dosing media not recommended, due to taste, includes any acidic food or juice (e. g., orange juice, apple juice or apple sauce).
Zaradi okusa ne mešajte praška s kislo hrano ali sokovi (npr. pomarančni sok, jabolčni sok, jabolčna čežana).
Do not add water to bottles of VIRACEPT 50 mg/ g oral powder.
V steklenico s peroralnim praškom VIRACEPT 50 mg/ g ne dodajajte vode.
Renal and hepatic impairment: there are no data specific for patients with renal impairment and therefore specific dosage recommendations cannot be made.
Ledvična in jetrna okvara: za bolnike z ledvično okvaro podatkov ni na voljo, zato posebnih priporočil o odmerjanju ni.
There are not sufficient data from patients with liver impairment and therefore specific dose recommendations cannot be made (see section 5.2).
Ustreznih podatkov za bolnike z jetrno okvaro ni, zato ni posebnih priporočil o odmerjanju (glejte poglavje 5. 2).
Co-administration with medicinal products with narrow therapeutic windows and which are substrates of CYP3A4 [e. g., terfenadine, astemizole, cisapride, amiodarone, quinidine, pimozide, triazolam, orally administered midazolam (for caution on parenterally administered midazolam, see section 4.5), ergot derivatives; see section 4.5].
Sočasno jemanje z zdravili, ki imajo ozko terapevtsko okno in ki so substrati za CYP3A4 (npr. terfenadin, astemizol, cisaprid, amiodaron, kvinidin, pimozid, triazolam, peroralno dan midazolam (za previdnost pri parenteralnih oblikah midazolama glejte poglavje 4. 5), derivati ergot; glejte poglavje 4. 5).
Co-administration with rifampicin (see section 4.5).
Sočasno jemanje z rifampicinom (glejte poglavje 4. 5)
John’ s wort (Hypericum perforatum) must not be used while taking nelfinavir due to the risk of decreased plasma concentrations and reduced clinical effects of nelfinavir (see section 4.5).
Pripravki rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), se med jemanjem nelfinavirja ne smejo uporabljati, ker se lahko zmanjšata koncentracija nelfinavirja v plazmi in njegov terapevtski učinek (glejte poglavje 4. 5).
VIRACEPT should not be co-administered with omeprazole due to a reduction in exposure to nelfinavir and its active metabolite M8.
Zdravila VIRACEPT ne smemo sočasno jemati z omeprazolom zaradi zmanjšane izpostavljenosti nelfinavirju in njegovemu aktivnemu presnovku M8.
This may lead to a loss of virologic response and possible resistance to VIRACEPT (see section 4.5).
Zaradi tega lahko pride do izgube virološkega odziva in možne rezistence na zdravilo VIRACEPT (glejte poglavje 4. 5).
In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Sindrom imunske reaktivacije: pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART - "combination antiretroviral therapy") nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične patogene in povzroči resna klinična stanja ali poslabšanje simptomov.
The safety and efficacy of nelfinavir has not been established in patients with significant underlying liver disorders.
Jetrna bolezen: varnost in učinkovitost nelfinavirja pri bolnikih, ki imajo hude motnje jetrnega delovanja, nista bili raziskani.
Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Treba jih je spremljati v skladu s standardno prakso.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Če se pri takih bolnikih pojavijo znaki poslabšanja jetrne bolezni, je treba razmisliti o prekinitvi ali ukinitvi zdravljenja.
In the absence of such studies, caution should be exercised, as increases in nelfinavir levels and/ or increases in liver enzymes may occur.
Ker takih študij ni na voljo, je potrebna previdnost, saj se lahko pojavi povečanje koncentracij nelfinavirja in/ ali zvišanje koncentracij jetrnih encimov.