natgillin/translations-raw huggingface dataset:
Paediatric population: The pharmacokinetics of enfuvirtide have been studied in 37 paediatric patients. 
Pediatrična populacija: farmakokinetiko enfuvirtida so proučevali pri 37 pediatričnih bolnikih.
For storage conditions after reconstitution of the medicinal product, see section 6.3. 
Za pogoje shranjevanja po rekonstituciji zdravila glejte poglavje 6.3.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu.
Studies in guinea pigs indicated a potential for enfuvirtide to produce delayed contact hypersensitivity. 
Študije na morskih prašičkih so pokazale, da enfuvirtid lahko povzroči pozno kontaktno preobčutljivost.
The injection should be given at a site different from the preceding injection site and where there is no current injection site reaction. 
Injiciramo drugam, kot je bila dana prejšnja injekcija, in na mesto, kjer trenutno ni reakcije po injiciranju.
Other PK studies suggest no difference between Asians and Caucasians after adjusting exposure for body weight. 
Druge farmakokinetične študije ne kažejo razlik med Azijci in belci po prilagajanju telesne mase.
Fuzeon is used for the treatment of Human Immune deficiency Virus (HIV) - in combination with other antiretroviral medicines in patients infected with HIV. 
Kdaj naj se uporablja zdravilo Fuzeon Zdravilo Fuzeon uporabljamo za zdravljenje virusa humane imunske pomanjkljivosti (HIV) - v kombinaciji z drugimi protiretrovirusnimi zdravili pri bolnikih, ki so okuženi z virusom HIV.
Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis carinii pneumonia. 
Ustrezni primeri so citomegalovirusni retinitis, generalizirane in/ali žariščne okužbe z mikobakterijami in s Pneumocystis carinii povzročena pljučnica.
Where available, resistance testing may be appropriate (see sections 4.4 and 5.1). 
Če je mogoče, lahko testiramo rezistenco (glejte poglavji 4.4 in 5.1).
If you need help, ask your partner, a friend, or a family member. 
prosite vašega partnerja, prijatelja ali sorodnika.
What Fuzeon is and what it is used for What you need to know before you use Fuzeon How to use Fuzeon 
Kaj je zdravilo Fuzeon in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Fuzeon Kako jemati zdravilo Fuzeon
In addition there have been a small number of hypersensitivity reactions attributed to enfuvirtide and in some cases recurrence has occurred upon re-challenge (see section 4.4). 
Prišlo je tudi do manjšega števila preobčutljivostnih reakcij, pripisanih enfuvirtidu, v nekaterih primerih se je ob ponovni uvedbi zdravila reakcija ponovila (glejte poglavje 4.4).
The vast majority of ISRs occurred within the first week of Fuzeon administration and were associated with mild to moderate pain or discomfort at the injection site without limitation of usual activities. 
Velika večina lokalnih reakcij na mestu injiciranja se je pojavila v prvem tednu dajanja zdravila Fuzeon, povezane pa so bile z blago do zmerno bolečino ali neugodjem na mestu injiciranja brez omejevanja vsakodnevnih dejavnosti.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. 
Obvestite svojega zdravnika, farmacevta ali medicinsko sestro, če jemljete ali ste pred kratkim jemali katero koli zdravilo.
• You can inject into your upper arm, upper thigh or stomach area (abdomen). 
• Injicirate lahko v zgornji del roke, zgornji del stegna ali področje trebuha (abdomna).
• The active substance is enfuvirtide. 
• Učinkovina je enfuvirtid.
The relationship between the in vitro susceptibility of HIV-1 to enfuvirtide and inhibition of HIV-1 replication in humans has not been established. 
Razmerje med in vitro dovzetnostjo HIV-1 za enfuvirtid in zaviranjem replikacije HIV-1 pri ljudeh ni bilo ugotovljeno.
A statistically significant increase was seen for pneumonia and lymphadenopathy. 
Statistično značilno povečanje je bilo pri pljučnici in limfadenopatiji.
Patients should be informed that Fuzeon is not a cure for HIV-1 infection. 
Bolnikom moramo povedati, da zdravilo Fuzeon ne ozdravi okužbe z virusom HIV-1.
Mothers should be instructed not to breast-feed if they are receiving enfuvirtide because of the potential for HIV transmission and any possible undesirable effects in breast-fed infants. 
Materam, ki prejemajo enfuvirtid, moramo dojenje odsvetovati zaradi možnosti prenosa virusa HIV in drugih možnih neželenih učinkov pri dojenih dojenčkih.
However, if it is less than 6 hours before the next regular dose, the missed dose should be skipped 
Če pa je do naslednjega rednega odmerka manj kot 6 ur, potem naj izpuščenega odmerka ne vzamejo.
- Make sure you have 1.0 ml of liquid in the syringe (or whatever amount your doctor prescribed, if it is different). 
• Prepričajte se, da imate v injekcijski brizgi 1,0 ml raztopine (ali drugačno prostornino, če vam je tako predpisal zdravnik).
Gently turn the vial upside down. 
Nežno obrnite vialo z zgornjo stranjo navzdol.
Fuzeon contains the active substance enfuvirtide and belongs to a group of medicines called ‘antiretrovirals'. 
Zdravilo Fuzeon vsebuje učinkovino enfuvirtid in spada v skupino zdravil, ki se imenujejo protiretrovirusna zdravila.
This is where the bone tissue dies because the blood supply has been lost (death of bone tissue caused by loss of blood supply to the bone). 
To je bolezen, pri kateri kostno tkivo odmre zaradi izgube prekrvitve kosti (odmiranje kostnega tkiva zaradi nezadostne prekrvitve kosti).
All patients received an optimised background (OB) regimen consisting of 3 to 5 antiretroviral agents selected on the basis of the patient's prior treatment history, as well as baseline genotypic and phenotypic viral resistance measurements. 
Vsi bolniki so prejemali optimizirano temeljno zdravljenje, ki je vključevalo 3 do 5 protiretrovirusnih učinkovin, izbranih na podlagi bolnikovega predhodnega poteka zdravljenja, kot tudi izhodiščnih genotipskih in fenotipskih meritev virusne odpornosti.
2 ml vial, colourless glass type 1 
2 ml viala, brezbarvno steklo tipa 1
● When handling the syringe, do not touch the needle. 
● Ko držite injekcijsko brizgo, se ne dotikajte igle.
• If foaming happens, it may take longer for the powder to dissolve completely. 
• Če se pojavi penjenje, lahko traja dalj časa, da se prašek popolnoma raztopi.
• Make sure you have 1.1 ml of Water for Injections in the syringe. 
• Prepričajte se, da imate v injekcijski brizgi 1,1 ml vode za injekcije.
There were insufficient examples of multiple substitutions to determine any consistent patterns of substitutions or their effect on viral susceptibility to enfuvirtide. 
Primeri multiplih substitucij so bili nezadostni za določitev pravilnih substitucij ali njihovih učinkov na virusno dovzetnost za enfuvirtid.
• Your doctor has prescribed Fuzeon to help control your HIV infection. 
• Vaš zdravnik vam je predpisal zdravilo Fuzeon, da bi vam pomagal nadzirati vašo okužbo s
Solvent This medicinal product does not require any special storage conditions. 
Vehikel Za shranjevanje zdravila niso potrebna posebna navodila.
In case a Fuzeon dose is missed, patients should be instructed to administer the dose as soon as possible. 
V primeru izpuščenega odmerka zdravila Fuzeon je treba bolnikom naročiti, naj vzamejo izpuščeni odmerek takoj ko je mogoče.
• hold the plastic cap under the needle protector 
● držite plastični pokrov pod igelno zaščito,
Events included rash, fever, nausea and vomiting, chills, rigors, low blood pressure and elevated serum liver transaminases in various combinations, and possibly primary immune complex reaction, respiratory distress and glomerulonephritis. 
Dogodki so vključevali osip, vročino, slabost in bruhanje, mrzlico, rigor, nizek krvni tlak in povišane serumske koncentracije jetrnih transaminaz v različnih kombinacijah in možno primarno reakcijo imunskih kompleksov,
The Manufacturer responsible for batch release is Roche Pharma AG 
Izdelovalec, odgovoren za sproščanje zdravila Roche Pharma AG
Breast-feeding: It is not known whether enfuvirtide is secreted in human milk. 
Dojenje: Ni znano, ali se enfuvirtid izloča v materino mleko.
Section 7 tells you how to prepare Fuzeon and how to give yourself an injection. 
Poglavje 7 opisuje, kako pripraviti zdravilo Fuzeon in kako si lahko injekcijo date sami.
This is when your doctor may decide to no longer keep treating you with Fuzeon. 
Takrat se bo zdravnik lahko odločil, da prekinete z zdravljenjem z zdravilom Fuzeon.
If the reconstituted solution cannot be injected immediately, it must be kept refrigerated until use and used within 24 hours. 
Če pripravljene raztopine ni mogoče injicirati takoj, jo moramo do uporabe hraniti v hladilniku in uporabiti v 24 urah.
It is an inhibitor of the structural rearrangement of HIV-1 gp41 and functions by specifically binding to this virus protein extracellularly thereby blocking fusion between the viral cell membrane and the target cell membrane, preventing the viral RNA from entering into the target cell. 
Je zaviralec strukturnega preurejanja HIV-1 glikoproteina 41 in deluje s specifično zunajcelično vezavo na to virusno beljakovino ter tako prepreči zlitje virusne celične membrane in celične membrane tarčne celice ter onemogoči vstop virusne RNA v tarčno celico.
Fuzeon should be used with caution in these populations (see sections 4.2 and 5.2). 
Zdravilo Fuzeon moramo pri teh skupinah bolnikov uporabljati previdno (glejte poglavji 4.2 in 5.2).
Fuzeon helps by preventing this. 
Zdravilo Fuzeon pomaga tako, da ta vstop prepreči.
3 ml vial, colourless glass type 1 
3 ml viala, brezbarvno steklo tipa 1
When using a higher threshold for eosinophilia (>1.4 x 109/l), the patient exposure adjusted rate of eosinophilia is equal in both groups (1.8 patients with event per 100 patientyears). 
Če upoštevamo višji prag za eozinofilijo (> 1,4 x 109/l), je bolnikovi izpostavljenosti prilagojen delež eozinofilije enak v obeh skupinah (1,8 bolnikov z dogodkom na 100 bolnikovih let).
Also do not use the Water for Injections if you see any particles in the vial or if the water is cloudy. 
Prav tako ne uporabljajte vode za injekcije, če ste v viali opazili trdne delce ali če je voda motna.
 Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. 
• Znaki osteonekroze so togost sklepa, bolečine (zlasti v kolku, kolenu in rami) in težave z gibljivostjo.
Decrease in viral sensitivity was correlated to the degree of pre-treatment resistance to background therapy. 
Padec virusne občutljivosti je bil koreliran s stopnjo odpornosti pred zdravljenjem na režim temeljnega zdravljenja
If you have any of these reactions do not stop using Fuzeon, but talk to your doctor about any concerns you have. 
Če se pri vas pojavijo te reakcije, ne prenehajte z jemanjem zdravila Fuzeon, ampak se o njih pogovorite z zdravnikom.
For instructions on reconstitution before administration, see section 6.6. 
Za navodila glede rekonstitucije zdravila pred dajanjem glejte poglavje 6.6.
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. 
Bolnike morate poučiti, da dodajo vodo za injekcije in nato s konico prsta narahlo trkajo na vialo, dokler se prašek ne začne raztapljati.
In a rat model on the resistance to influenza infection, an impairment of IFN-γ production was observed. 
Na podganjem modelu za ugotavljanje odpornosti proti okužbi gripe so opazili oslabljeno nastajanje IFN-γ.
Step B: Mixing Fuzeon 
Korak B: mešanje zdravila Fuzeon
Step C: Preparing for the injection 
Korak C: priprava pred injiciranjem
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. 
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.
● Do not touch the tops of the vials once they have been cleaned with alcohol swabs. 
● Ne dotikajte se vrha viale, ko ste ga že očistili z alkoholnim zložencem.
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. 
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.
Dose per bid injection (mg/dose) 
Odmerek injekcije dvakrat na dan (mg/odmerek)
Pharmacotherapeutic group: Other antivirals, ATC code: J05AX07 
Farmakoterapevtska skupina: druga zdravila za sistemsko zdravljenje virusnih infekcij, oznaka ATC: J05AX 07.
There is no specific antidote for overdose with enfuvirtide. 
Za preveliko odmerjanje enfuvirtida ni specifičnega antidota.
If you accidentally touch the rubber stopper, make sure to clean it again with a new alcohol swab 
Če se po nesreči dotaknete gumijastega zamaška, ga ponovno očistite z alkoholnim zložencem.
Marketing Authorisation Holder Roche Registration GmbH Emil-Barell-Strasse 1 
Imetnik dovoljenja za promet z zdravilom Roche Registration GmbH Emil-Barell-Strasse 1
If you notice any symptoms of infection, please inform your doctor immediately. 
Če opazite kakršne koli znake okužbe, prosimo, da o tem takoj obvestite zdravnika.
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. 
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.
Percentages based on safety population Fuzeon+background (N=663) and background (N=334). 
Odstotki, osnovani na populaciji za proučevanje varnosti, ki so prejemali zdravilo Fuzeon + optimizirano temeljno zdravljenje (n = 663) in optimizirano temeljno zdravljenje (n = 334).
In HIV patients, enfuvirtide levels in the cerebrospinal fluid have been reported to be negligible. 
Pri bolnikih, okuženih s HIV, so poročali o zanemarljivo majhnih vrednosti enfuvirtida v cerebrospinalni tekočini.
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. 
V in vitro študijah druga zdravila niso izpodrivala enfurvitida z njegovih vezalnih mest in tudi enfuvirtid ni izpodrival drugih zdravil z njihovih vezalnih mest.
To make sure that the needle is firmly on the syringe: 
Da boste zagotovili, da je injekcijska igla trdno pritrjena na injekcijsko brizgo:
Fuzeon has been shown not to interact with your other anti-HIV medicines or rifampicin (an antibiotic). 
Za zdravilo Fuzeon so dokazali, da medsebojno ne deluje z vašimi drugimi zdravili proti HIV ali z rifampicinom
The pharmacokinetic properties of enfuvirtide have been evaluated in HIV-1-infected adult and paediatric patients. 
Farmakokinetične lastnosti enfuvirtida so bile vrednotene pri odraslih bolnikih in otrocih, okuženih z virusom HIV-1.
Infections at the injection site (including abscess and cellulitis) occurred in 1.5% of patients. 
1,5 % bolnikov so se pojavile okužbe na mestu injiciranja (vključno z abscesi in celulitisom).
Take out the needle from the vial. 
Izvlecite iglo iz viale.
Some patients taking combination anti-HIV medicines may develop a bone disease called osteonecrosis. 
Pri nekaterih bolnikih, ki jemljejo kombinirano zdravljenje proti virusu HIV, se lahko pojavi bolezen kosti, imenovana osteonekroza.
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 
Ime in naslov izdelovalca, odgovornega za sproščanje serije Roche Pharma AG, Emil-Barrell-Str. 1, D-79639 Grenzach-Wyhlen, Nemčija
In four separate studies (N = 9 to 12) the mean steady state trough plasma concentration ranged from 2.6 to 3.4 µg/ml. 
V štirih ločenih študijah (n = 9 do 12) so povprečne plazemske koncentracije v stanju dinamičnega ravnovesja pred naslednjim odmerkom obsegale vrednosti od 2,6
• you have ever had any lung problems 
• ste imeli v preteklosti kakršne koli težave s pljuči, • ste imeli v preteklosti kakršne koli težave z ledvicami,
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. 
Odrasli in mladostniki ≥ 16 let: priporočeni odmerek zdravila Fuzeon je 90 mg dvakrat na dan, injicirano subkutano v nadlaket, sprednjo stran stegna ali trebuh.
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. 
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.
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) 
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)
As a peptide, enfuvirtide can cause cutaneous amyloidosis at the injection site. 
Kot peptid lahko enfuvirtid povzroči kožno amiloidozo na mestu injiciranja.
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART. 
Opisani so bili primeri osteonekroze, še zlasti pri bolnikih s splošno znanimi dejavniki tveganja, napredovalo boleznijo HIV ali dolgotrajno izpostavljenostjo kombiniranemu protiretrovirusnemu zdravljenju (CART).
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). 
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).
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). 
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).
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. 
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.
● Do not inject Fuzeon into your veins (‘intravenously') or into your muscles (‘intramuscularly'). 
● Ne injicirajte si zdravila Fuzeon v vene (intravensko) ali mišice (intramuskularno).
No clinically significant pharmacokinetic interactions are expected between enfuvirtide and concomitantly given medicinal products metabolised by CYP450 enzymes. 
Klinično pomembna farmakokinetična medsebojna delovanja med enfuvirtidom in sočasno danimi zdravili, ki se presnavljajo z encimi CYP450, niso pričakovana.
Of these, 185 (98.9%) env genes carried specific substitutions in region of aa 36 - 45 of gp41. 
(98,9 %) env-genov imelo specifične substitucije v regiji AK 36-45 glikoproteina 41.
Rarely, you may get an infection at a place where an individual injection was given. 
V redkih primerih se lahko pojavi okužba na posameznem mestu injiciranja.
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). 
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).
Hypersensitivity reactions have occasionally been associated with therapy with enfuvirtide and in rare cases hypersensitivity reactions have recurred on rechallenge. 
Preobčutljivostne reakcije so občasno povezovali z zdravljenjem z enfuvirtidom, v redkih primerih so se preobčutljivostne reakcije ponovile ob ponovni uvedbi zdravila.
Safety data mainly refer to 48-week data from studies TORO 1 and TORO 2 combined (see section 5.1). 
Podatki o varnosti se v glavnem nanašajo na združene rezultate študij TORO 1 in TORO 2 v 48. tednu (glejte poglavje 5.1).
Putting in the needle and injecting 
Vstavljanje igle in injiciranje
Fuzeon has not been tested for its effect on your ability to drive a car or use tools or machines. 
Vpliv na sposobnost upravljanja vozil in strojev Možnih učinkov zdravila Fuzeon na vašo sposobnost vožnje avtomobila ali uporabe orodij oziroma upravljanja strojev niso preskušali.
Patients with chronic hepatitis B or C and treated with anti-HIV therapy are at an increased risk for serious liver problems. 
Bolniki s kroničnim hepatitisom B ali C, ki prejemajo zdravljenje proti virusu HIV, imajo večje tveganje za resne težave z jetri.
Patients developing signs/symptoms of a systemic hypersensitivity reaction should discontinue enfuvirtide treatment and should seek medical evaluation immediately. 
Bolniki, pri katerih se pojavijo znaki ali simptomi sistemske preobčutljivostne reakcije, morajo z zdravljenjem z enfuvirtidom prenehati in takoj poiskati zdravniško pomoč.
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. 
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.
Haemodialysis did not significantly alter enfuvirtide clearance. 
Hemodializa ni signifikantno spremenila očistka enfuvirtida.
Fuzeon must only be reconstituted with 1.1 ml of Water for Injections. 
Zdravilo Fuzeon lahko pripravimo samo z 1,1 ml vode za injekcije.