FrancophonIA/ELRC3.0 huggingface dataset:
English: Decrease in viral sensitivity was correlated to the degree of pre-treatment resistance to background therapy.
Slovenian: Padec virusne občutljivosti je bil koreliran s stopnjo odpornosti pred zdravljenjem na režim temeljnega zdravljenja
English: If you have any of these reactions do not stop using Fuzeon, but talk to your doctor about any concerns you have.
Slovenian: Če se pri vas pojavijo te reakcije, ne prenehajte z jemanjem zdravila Fuzeon, ampak se o njih pogovorite z zdravnikom.
English: For instructions on reconstitution before administration, see section 6.6.
Slovenian: Za navodila glede rekonstitucije zdravila pred dajanjem glejte poglavje 6.6.
English: Patients must be instructed to add the water for injections and then gently tap the vial with their fingertip until the powder begins to dissolve.
Slovenian: Bolnike morate poučiti, da dodajo vodo za injekcije in nato s konico prsta narahlo trkajo na vialo, dokler se prašek ne začne raztapljati.
English: In a rat model on the resistance to influenza infection, an impairment of IFN-γ production was observed.
Slovenian: Na podganjem modelu za ugotavljanje odpornosti proti okužbi gripe so opazili oslabljeno nastajanje IFN-γ.
English: Step B: Mixing Fuzeon
Slovenian: Korak B: mešanje zdravila Fuzeon
English: Step C: Preparing for the injection
Slovenian: Korak C: priprava pred injiciranjem
English: Race: Analysis of plasma concentration data from patients in clinical trials indicated that the clearance of enfuvirtide was not different in Afro-Americans compared to Caucasians.
Slovenian: Rasa: analiza podatkov o plazemskih koncentracijah pri bolnikih v kliničnih preskušanjih je pokazala, da se očistek enfuvirtida pri Afroameričanih v primerjavi z belci ne razlikuje.
English: ● Do not touch the tops of the vials once they have been cleaned with alcohol swabs.
Slovenian: ● Ne dotikajte se vrha viale, ko ste ga že očistili z alkoholnim zložencem.
English: In in vitro human microsomal and hepatocyte studies, hydrolysis of the amide group of the C-terminus amino acid, phenylalanine results in a deamidated metabolite and the formation of this metabolite is not NADPH dependent.
Slovenian: V in vitro mikrosomalnih ter hepatocitnih študijah pri ljudeh s hidrolizo amidne skupine C-terminalnega konca aminokisline fenilalanina nastane deamidiran presnovek, tvorba tega presnovka ni odvisna od NADPH.
English: Dose per bid injection (mg/dose)
Slovenian: Odmerek injekcije dvakrat na dan (mg/odmerek)
English: Pharmacotherapeutic group: Other antivirals, ATC code: J05AX07
Slovenian: Farmakoterapevtska skupina: druga zdravila za sistemsko zdravljenje virusnih infekcij, oznaka ATC: J05AX 07.
English: There is no specific antidote for overdose with enfuvirtide.
Slovenian: Za preveliko odmerjanje enfuvirtida ni specifičnega antidota.
English: If you accidentally touch the rubber stopper, make sure to clean it again with a new alcohol swab
Slovenian: Če se po nesreči dotaknete gumijastega zamaška, ga ponovno očistite z alkoholnim zložencem.
English: Marketing Authorisation Holder Roche Registration GmbH Emil-Barell-Strasse 1
Slovenian: Imetnik dovoljenja za promet z zdravilom Roche Registration GmbH Emil-Barell-Strasse 1
English: If you notice any symptoms of infection, please inform your doctor immediately.
Slovenian: Če opazite kakršne koli znake okužbe, prosimo, da o tem takoj obvestite zdravnika.
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Slovenian: Pri nekaterih bolnikih z napredovalo okužbo s HIV (AIDS) in z oportunističnimi okužbami v anamnezi se lahko kmalu po začetku anti-HIV zdravljenja pojavijo znaki in simptomi vnetja, povezani s prejšnjimi okužbami.
English: Percentages based on safety population Fuzeon+background (N=663) and background (N=334).
Slovenian: Odstotki, osnovani na populaciji za proučevanje varnosti, ki so prejemali zdravilo Fuzeon + optimizirano temeljno zdravljenje (n = 663) in optimizirano temeljno zdravljenje (n = 334).
English: In HIV patients, enfuvirtide levels in the cerebrospinal fluid have been reported to be negligible.
Slovenian: Pri bolnikih, okuženih s HIV, so poročali o zanemarljivo majhnih vrednosti enfuvirtida v cerebrospinalni tekočini.
English: In in vitro studies, enfuvirtide was not displaced from its binding sites by other medicinal products, nor did enfuvirtide displace other medicinal products from their binding sites.
Slovenian: V in vitro študijah druga zdravila niso izpodrivala enfurvitida z njegovih vezalnih mest in tudi enfuvirtid ni izpodrival drugih zdravil z njihovih vezalnih mest.
English: To make sure that the needle is firmly on the syringe:
Slovenian: Da boste zagotovili, da je injekcijska igla trdno pritrjena na injekcijsko brizgo:
English: Fuzeon has been shown not to interact with your other anti-HIV medicines or rifampicin (an antibiotic).
Slovenian: Za zdravilo Fuzeon so dokazali, da medsebojno ne deluje z vašimi drugimi zdravili proti HIV ali z rifampicinom
English: The pharmacokinetic properties of enfuvirtide have been evaluated in HIV-1-infected adult and paediatric patients.
Slovenian: Farmakokinetične lastnosti enfuvirtida so bile vrednotene pri odraslih bolnikih in otrocih, okuženih z virusom HIV-1.
English: Infections at the injection site (including abscess and cellulitis) occurred in 1.5% of patients.
Slovenian: 1,5 % bolnikov so se pojavile okužbe na mestu injiciranja (vključno z abscesi in celulitisom).
English: Take out the needle from the vial.
Slovenian: Izvlecite iglo iz viale.
English: Some patients taking combination anti-HIV medicines may develop a bone disease called osteonecrosis.
Slovenian: Pri nekaterih bolnikih, ki jemljejo kombinirano zdravljenje proti virusu HIV, se lahko pojavi bolezen kosti, imenovana osteonekroza.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Roche Pharma AG, Emil-Barrell-Str. 1, D-79639 Grenzach-Wyhlen, Germany
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serije Roche Pharma AG, Emil-Barrell-Str. 1, D-79639 Grenzach-Wyhlen, Nemčija
English: In four separate studies (N = 9 to 12) the mean steady state trough plasma concentration ranged from 2.6 to 3.4 µg/ml.
Slovenian: V štirih ločenih študijah (n = 9 do 12) so povprečne plazemske koncentracije v stanju dinamičnega ravnovesja pred naslednjim odmerkom obsegale vrednosti od 2,6
English: • you have ever had any lung problems
Slovenian: • ste imeli v preteklosti kakršne koli težave s pljuči, • ste imeli v preteklosti kakršne koli težave z ledvicami,
English: Adults and adolescents ≥ 16 years: The recommended dose of Fuzeon is 90 mg twice daily injected subcutaneously into the upper arm, anterior thigh or abdomen.
Slovenian: Odrasli in mladostniki ≥ 16 let: priporočeni odmerek zdravila Fuzeon je 90 mg dvakrat na dan, injicirano subkutano v nadlaket, sprednjo stran stegna ali trebuh.
English: Elimination: Clearance of enfuvirtide after intravenous administration 90 mg was 1.4 ± 0.28 l/h and the elimination half-life was 3.2 ± 0.42 h. Following a 90 mg subcutaneous dose of enfuvirtide the half-life of enfuvirtide is 3.8 ± 0.6 h. Mass balance studies to determine elimination pathway(s) of enfuvirtide have not been performed in humans.
Slovenian: Izločanje: očistek enfuvirtida po intravenskem dajanju 90 mg je bil 1,4 ± 0,28 l/h, razpolovni čas izločanja je bil 3,2 ± 0,42 h. Po 90-mg subkutanem odmerku enfuvirtida je razpolovni čas enfuvirtida 3,8 ± 0,6 h. Študije masnega ravnovesja za določanje poti izločanja enfuvirtida pri ljudeh niso bile izvedene.
English: Table 6 Proportion of Patients achieving <400 copies/ml and <50 copies/ml at Week 48 by subgroup (pooled TORO 1 and TORO 2, ITT)
Slovenian: Preglednica 6 Delež bolnikov, ki so v 48. tednu dosegli < 400 kopij/ml in < 50 kopij/ml po podskupinah (združeni TORO 1 in TORO 2, ITT)
English: As a peptide, enfuvirtide can cause cutaneous amyloidosis at the injection site.
Slovenian: Kot peptid lahko enfuvirtid povzroči kožno amiloidozo na mestu injiciranja.
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART.
Slovenian: Opisani so bili primeri osteonekroze, še zlasti pri bolnikih s splošno znanimi dejavniki tveganja, napredovalo boleznijo HIV ali dolgotrajno izpostavljenostjo kombiniranemu protiretrovirusnemu zdravljenju (CART).
English: Influence of enfuvirtide on metabolism of concomitant medicinal products: In an in-vivo human metabolism study enfuvirtide, at the recommended dose of 90 mg twice daily, did not inhibit the metabolism of substrates by CYP3A4 (dapsone), CYP2D6 (debrisoquine), CYP1A2 (caffeine), CYP2C19 (mephenytoin), and CYP2E1 (chlorzoxazone).
Slovenian: Vpliv enfuvirtida na presnovo sočasno dajanih zdravil: enfuvirtid v in vivo študiji presnove pri ljudeh v priporočenem odmerku 90 mg dvakrat na dan ni zaviral presnove substratov s CYP3A4 (dapson), CYP2D6 (debrisokvin), CYP1A2 (kofein), CYP2C19 (mefenitoin) in CYP2E1 (klorzoksazon).
English: Fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes: protease inhibitors, nonnucleoside reverse transcriptase inhibitors and nucleoside reverse transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens (see section 5.1).
Slovenian: 4.1 Terapevtske indikacije Zdravilo Fuzeon je v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje bolnikov, okuženih s HIV-1, in neuspešno zdravljenih z režimi zdravljenja, ki so vsebovali vsaj eno od zdravil iz vsakega od naslednjih protiretrovirusnih razredov: zaviralcev proteaz, nenukleozidnih zaviralcev reverzne transkriptaze in nukleozidnih zaviralcev reverzne transkriptaze, ali bolnikov, ki prejšnjih protiretrovirusnih režimov zdravljenja ne prenašajo (glejte poglavje 5.1).
English: Tél: +33 (0) 1 47 61 40 00
Slovenian: Roche Tél: +33 (0) 1 47 61 40 00
English: Biotransformation: As a peptide, enfuvirtide is expected to undergo catabolism to its constituent amino acids, with subsequent recycling of the amino acids in the body pool.
Slovenian: Biotransformacija: kot za peptid se za enfuvirtid pričakuje, da bo podvržen razgradnji v svoje sestavne aminokisline s posledično predelavo aminokislin iz telesnih zalog za ponovno uporabo.
English: ● Do not inject Fuzeon into your veins (‘intravenously') or into your muscles (‘intramuscularly').
Slovenian: ● Ne injicirajte si zdravila Fuzeon v vene (intravensko) ali mišice (intramuskularno).
English: No clinically significant pharmacokinetic interactions are expected between enfuvirtide and concomitantly given medicinal products metabolised by CYP450 enzymes.
Slovenian: Klinično pomembna farmakokinetična medsebojna delovanja med enfuvirtidom in sočasno danimi zdravili, ki se presnavljajo z encimi CYP450, niso pričakovana.
English: Of these, 185 (98.9%) env genes carried specific substitutions in region of aa 36 - 45 of gp41.
Slovenian: (98,9 %) env-genov imelo specifične substitucije v regiji AK 36-45 glikoproteina 41.
English: Rarely, you may get an infection at a place where an individual injection was given.
Slovenian: V redkih primerih se lahko pojavi okužba na posameznem mestu injiciranja.
English: Cross-resistance: Due to its novel viral target enfuvirtide is equally active in vitro against both wildtype laboratory and clinical isolates and those with resistance to 1, 2 or 3 other classes of antiretrovirals (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors and protease inhibitors).
Slovenian: Navzkrižna odpornost: zaradi svoje nove virusne tarče je enfuvirtid enako učinkovit in vitro proti divjemu tipu laboratorijskih in kliničnih izolatov in tudi proti tistim z odpornostjo proti 1, 2 ali 3 drugim razredom protiretrovirusnih učinkovin (nukleozidni zaviralci reverzne transkriptaze, nenukleozidni zaviralci reverzne transkriptaze in zaviralci proteaz).
English: Hypersensitivity reactions have occasionally been associated with therapy with enfuvirtide and in rare cases hypersensitivity reactions have recurred on rechallenge.
Slovenian: Preobčutljivostne reakcije so občasno povezovali z zdravljenjem z enfuvirtidom, v redkih primerih so se preobčutljivostne reakcije ponovile ob ponovni uvedbi zdravila.
English: Safety data mainly refer to 48-week data from studies TORO 1 and TORO 2 combined (see section 5.1).
Slovenian: Podatki o varnosti se v glavnem nanašajo na združene rezultate študij TORO 1 in TORO 2 v 48. tednu (glejte poglavje 5.1).
English: Putting in the needle and injecting
Slovenian: Vstavljanje igle in injiciranje
English: Fuzeon has not been tested for its effect on your ability to drive a car or use tools or machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Možnih učinkov zdravila Fuzeon na vašo sposobnost vožnje avtomobila ali uporabe orodij oziroma upravljanja strojev niso preskušali.
English: Patients with chronic hepatitis B or C and treated with anti-HIV therapy are at an increased risk for serious liver problems.
Slovenian: Bolniki s kroničnim hepatitisom B ali C, ki prejemajo zdravljenje proti virusu HIV, imajo večje tveganje za resne težave z jetri.
English: Patients developing signs/symptoms of a systemic hypersensitivity reaction should discontinue enfuvirtide treatment and should seek medical evaluation immediately.
Slovenian: Bolniki, pri katerih se pojavijo znaki ali simptomi sistemske preobčutljivostne reakcije, morajo z zdravljenjem z enfuvirtidom prenehati in takoj poiskati zdravniško pomoč.
English: In Vivo resistance to enfuvirtide: In phase III clinical studies HIV recombinants containing the env genes from HIV RNA samples taken up to week 24 from 187 patients showed > 4 fold reduced susceptibility to enfuvirtide compared with the corresponding pre-treatment samples.
Slovenian: In vivo odpornost proti enfuvirtidu: v kliničnih študijah faze III so rekombinante HIV, vsebujoče envgene iz vzorcev HIV-RNA, odvzetih do 24. tedna pri 187 bolnikih, pokazale > 4-krat zmanjšano dovzetnost za enfuvirtid v primerjavi z ustreznimi vzorci, odvzetimi pred zdravljenjem.
English: Haemodialysis did not significantly alter enfuvirtide clearance.
Slovenian: Hemodializa ni signifikantno spremenila očistka enfuvirtida.
English: Fuzeon must only be reconstituted with 1.1 ml of Water for Injections.
Slovenian: Zdravilo Fuzeon lahko pripravimo samo z 1,1 ml vode za injekcije.
English: Once a dose is mixed with Water for Injections, it must be used straight away.
Slovenian: Ko ste odmerek raztopili z vodo za injekcije, ga morate uporabiti takoj.
English: Administration of Fuzeon to non-HIV-1 infected individuals may induce anti-enfuvirtide antibodies that cross-react with HIV gp41.
Slovenian: Dajanje zdravila Fuzeon posameznikom, ki niso okuženi z virusom HIV-1, lahko povzroči nastanek protiteles proti enfuvirtidu, ki navzkrižno reagirajo s HIV glikoproteinom 41.
English: 15.6 to 20.0
Slovenian: 15,6 do 20,0
English: Studies in Antiretroviral Experienced Patients: The clinical activity of Fuzeon (in combination with other antiretroviral agents) on plasma HIV RNA levels and CD4 counts have been investigated in two randomised, multicentre, controlled studies (TORO 1 and TORO 2) of Fuzeon of 48 weeks duration.
Slovenian: Študije pri bolnikih, ki so že prejemali protiretrovirusna zdravila: klinično učinkovitost zdravila Fuzeon (v kombinaciji z drugimi protiretrovirusnimi učinkovinami) na plazemske koncentracije HIVRNA in število celic CD4 so preiskovali v dveh randomiziranih, multicentričnih, nadzorovanih študijah (TORO 1 in TORO 2) zdravila Fuzeon, ki sta trajali 48 tednov.
English: • This is given as a 1 ml injection just below the skin.
Slovenian: • To damo kot 1-ml injekcijo tik pod kožo.
English: Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
Slovenian: Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Nemčija
English: The most frequently reported events were injection site reactions, diarrhoea and nausea.
Slovenian: Najpogosteje poročani neželeni učinki so bile reakcije na mestu injiciranja, diareja in navzea.
English: Influence of concomitant medicinal products on enfuvirtide metabolism: In separate pharmacokinetic interaction studies, co-administration of ritonavir (potent CYP3A4 inhibitor) or saquinavir in combination with a booster dose of ritonavir or rifampicin (potent CYP34A inducer) did not result in clinically significant changes of the pharmacokinetics of enfuvirtide.
Slovenian: Vpliv sočasno dajanih zdravil na presnovo enfuvirtida: v ločenih farmakokinetičnih študijah medsebojnega delovanja sočasno dajanje ritonavirja (močnega zaviralca CYP3A4) ali sakvinavirja v kombinaciji z obnovitvenim odmerkom ritonavirja ali rifampicina (močnega induktorja CYP34A) ni povzročilo klinično pomembnih sprememb farmakokinetike enfuvirtida.
English: Specific single substitutions at these residues in gp41 each resulted in a range of decreases from baseline in recombinant viral susceptibility to enfuvirtide.
Slovenian: Vsaka specifična posamezna substitucija na teh ostankih v glikoproteinu 41 je povzročila zmanjšanje razpona od izhodiščne vrednosti v rekombinantni dovzetnosti virusa za enfuvirtid.
English: Antiviral activity in vitro: The susceptibility to enfuvirtide of 612 HIV recombinants containing the env genes from HIV RNA samples taken at baseline from patients in Phase III studies gave a geometric mean EC 50 of 0.259 µg/ml (geometric mean + 2SD = 1.96 µg/ml) in a recombinant phenotype HIV entry assay.
Slovenian: Protivirusno delovanje in vitro: dovzetnost za enfuvirtid 612 HIV rekombinant, ki vsebuje env-gene iz vzorcev HIV-RNA, odvzetih ob izhodišču bolnikom v študijah faze III, je dala geometrično sredino EC50 0,259 µg/ml (geometrična sredina + 2SD = 1,96 µg/ml) v preskusu vstopa rekombinantnega fenotipa HIV.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Slovenian: V normalnih razmerah naj ne bi presegali 24 ur pri 2 do 8 °C, razen če je bila rekonstitucija opravljena v nadzorovanih in validiranih aseptičnih pogojih.
English: Once the solution has been prepared for your injection it should be used immediately.
Slovenian: Ko je raztopina za vašo injekcijo pripravljena, jo morate takoj uporabiti.
English: Contained in this box are 60 vials of 2 ml water for injections
Slovenian: V tej škatli je 60 vial po 2 ml vode za injekcije
English: Tell your doctor if you get side effects where the injection is given The most common side effects (affect more than 1 in 10 people), are problems at the place on your body where you have the injection.
Slovenian: Najpogostejši neželeni učinki (pojavijo se pri več kot 1 od 10 bolnikov) so težave na delu telesa, kjer dobite injekcijo.
English: Mechanism of Action: Enfuvirtide is a member of the therapeutic class called fusion inhibitors.
Slovenian: Mehanizem delovanja: enfuvirtid spada v terapevtski razred, imenovan zaviralci zlitja.
English: Do not use your free hand to press the device over the needle.
Slovenian: Ne uporabljajte vaše proste roke za potisk na pripomoček, da bi pokrili iglo.
English: Contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Slovenian: Vsebuje manj kot 1 mmol (23 mg na odmerek) natrija, kar v bistvu pomeni ‘brez natrija'.
English: Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to CART.
Slovenian: Osteonekroza: čeprav je vzrokov verjetno več (vključno z uporabo kortikosteroidov, uživanjem alkohola, hudo imunosupresijo, višjim indeksom telesne mase), so o primerih osteonekroze poročali zlasti pri bolnikih z napredovalo boleznijo HIV ali dolgotrajno izpostavljenostjo kombiniranemu protiretrovirusnemu zdravljenju (CART) ali obojim.
English: The remaining Water for Injections in the solvent vial after withdrawal of the 1.1 ml required for reconstitution has to be discarded
Slovenian: Preostanek vode za injekcije v viali z vehiklom je po odvzemu 1,1 ml, potrebnega za rekonstitucijo,
English: If you notice any of these signs please inform your doctor.
Slovenian: Če opazite katerega od teh simptomov, prosimo obvestite zdravnika.
English: Elderly: The pharmacokinetics of enfuvirtide have not been formally studied in elderly patients over 65 years of age.
Slovenian: Starejši: farmakokinetike enfuvirtida niso proučevali pri bolnikih, starejših od 65 let.
English: Draw back 1 ml of air. - Be careful not to pull the plunger too fast - it may go past the 1 ml marker or out of the syringe.
Slovenian: • Pazite, da ne boste potegnili bata prehitro - lahko gre preko oznake 1 ml ali izven injekcijske brizge.
English: Patients had prior exposure to a median of 12 antiretrovirals for a median of 7 years.
Slovenian: protiretrovirusnih zdravil za mediano obdobje 7 let.
English: ● pain, feeling sore or tender These reactions can appear in the first week of treatment and usually only last for up to 7 days.
Slovenian: Te reakcije se lahko pojavijo v prvem tednu zdravljenja in običajno trajajo 7 dni ali manj.
English: The following is a basic, step-by-step guide to injecting your medicine.
Slovenian: Spodaj so navedena osnovna navodila po korakih, kako si injicirate vaše zdravilo.
English: Peripheral neuropathy Hypoaesthesia, disturbance in attention, tremor
Slovenian: Bolezni živčevja zelo pogosti pogosti periferna nevropatija hipestezija, motnje v pozornosti, tremor
English: White to off-white lyophilised powder.
Slovenian: Bel do sivo bel liofiliziran prašek.
English: Distribution: The steady state volume of distribution with intravenous administration of a 90 mg dose of enfuvirtide was 5.5 ± 1.1 l. Enfuvirtide is 92% bound to plasma proteins in HIV infected plasma over a plasma concentration range of 2 to 10 µg/ml.
Slovenian: Porazdelitev: volumen porazdelitve v stanju dinamičnega ravnovesja po intravenskem dajanju enfuvirtida v odmerku 90 mg je bil 5,5 ± 1,1 l. Enfuvirtid se v plazmi, okuženi s HIV, v 92 % veže na plazemske beljakovine prek razpona plazemskih koncentracij od 2 do 10 µg/ml.
English: 24.6 to 29.0
Slovenian: 24,6 do 29,0
English: 33.6 to 38.0
Slovenian: 33,6 do 38,0
English: Refrigerated reconstituted solution should be brought to room temperature before injection.
Slovenian: Ohlajeno pripravljeno raztopino moramo pred injiciranjem segreti na sobno temperaturo.
English: Patients with chronic hepatitis B and C and treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse events.
Slovenian: Bolniki s kroničnim hepatitisom B in C, ki prejemajo protiretrovirusna zdravila, so izpostavljeni povečanemu tveganju za hude in potencialno smrtne jetrne neželene dogodke.
English: 79639 Grenzach-Wyhlen Germany
Slovenian: 79639 Grenzach-Wyhlen Nemčija
English: Fuzeon contains no preservative.
Slovenian: Zdravilo Fuzeon ne vsebuje konzervansa.
English: ● Only inject Fuzeon under the skin (‘subcutaneous').
Slovenian: ● Zdravilo Fuzeon injicirajte le pod kožo (subkutano).
English: Liver disease: The safety and efficacy of enfuvirtide has not been specifically studied in patients with significant underlying liver disorders.
Slovenian: Bolezni jeter: varnosti in učinkovitosti enfuvirtida pri bolnikih s pomembnimi predhodnimi obolenji jeter niso posebej raziskovali.