FrancophonIA/ELRC3.0 huggingface dataset:
English: The patient can gently roll the vial between their hands after adding the water for injections until it is fully dissolved and this may reduce the time it takes for the powder to dissolve.
Slovenian: Bolnik lahko po dodatku vode za injekcije vialo narahlo povalja med dlanmi, dokler vsebina ni popolnoma raztopljena, kar lahko skrajša čas, potreben za popolno raztopitev praška.
English: If you use more Fuzeon than you should, talk to a doctor or go to a hospital straight away.
Slovenian: Če ste uporabili večji odmerek zdravila Fuzeon, kot bi smeli Če ste uporabili odmerek zdravila Fuzeon, ki je večji od priporočenega, se posvetujte z zdravnikom ali takoj pojdite v bolnišnico.
English: Clean the area for injection well with an alcohol swab.
Slovenian: Čiščenje mesta injiciranja Področje za injiciranje temeljito očistite z alkoholnim zložencem.
English: They must never shake the vial or turn it upside down to mix-this will cause excessive foaming.
Slovenian: Viale nikoli ne smejo stresati ali je obračati z vrhom navzdol, da bi mešali vsebino − to bi povzročilo čezmerno penjenje.
English: Follow the instructions given to you by your doctor, pharmacist or nurse.
Slovenian: Prosimo, sledite navodilom, ki ste jih prejeli od vašega zdravnika, farmacevta ali medicinske sestre.
English: • not being able to concentrate
Slovenian: • pomanjkanje koncentracije,
English: There is no experience in patients with reduced hepatic function.
Slovenian: Pri bolnikih z oslabljeno jetrno funkcijo ni izkušenj.
English: Therapy with enfuvirtide should not be restarted following systemic signs and symptoms consistent with a hypersensitivity reaction considered related to enfuvirtide.
Slovenian: Zdravljenja z enfuvirtidom pri bolnikih, pri katerih so se pojavili sistemski znaki in simptomi v skladu s preobčutljivostno reakcijo, ki se šteje za povezano z enfuvirtidom, ne smemo ponovno uvesti.
English: Anxiety, nightmare, irritability
Slovenian: • nočne more, • omotičnost,
English: Renal impairment: Analysis of plasma concentration data from patients in clinical trials indicated that the clearance of enfuvirtide is not affected to any clinically relevant extent in patients with mild to moderate renal impairment.
Slovenian: Ledvična okvara: analiza podatkov plazemskih koncentracij pri bolnikih v kliničnih preskušanjih je pokazala, da očistek enfuvirtida pri bolnikih z blago do zmerno ledvično okvaro ni spremenjen v klinično pomembnem obsegu.
English: Roche Slovensko, s.r.o.
Slovenian: Slovenská republika Roche Slovensko, s.r.o.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Slovenian: Poročajo o avtoimunskih boleznih (kot sta Gravesova bolezen in avtoimunski hepatitis); čas do njihovega nastanka je spremenljiv, zato se lahko pojavijo tudi več mesecev po začetku zdravljenja (glejte poglavje 4.4).
English: Table 5 Outcomes of Randomised Treatment at Week 48 (Pooled Studies TORO 1 and TORO 2, ITT) Outcomes
Slovenian: Preglednica 5 Izidi randomiziranega zdravljenja v 48. tednu (združenih študij TORO 1 in TORO 2, ITT)
English: 2Based on GSS score.
Slovenian: 2Osnovani na rezultatih genotipske občutljivosti (GSS-Genotypic Senstivity Score).
English: In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Slovenian: Znaki avtoimunskih bolezni Poleg oportunističnih okužb se lahko po začetku jemanja zdravil za zdravljenje okužbe s HIV pojavijo tudi avtoimunske bolezni (stanja, do katerih pride, ko imunski sistem napade zdravo telesno tkivo).
English: Gently tap the vial with your fingertip until the powder begins to dissolve.
Slovenian: Narahlo trkajte na vialo s konico prsta, dokler se prašek ne začne raztapljati.
English: D-79639 Grenzach-Wyhlen Germany
Slovenian: D-79639 Grenzach-Wyhlen Nemčija
English: Adverse reactions are listed according to MedDRA system organ class and frequency category.
Slovenian: Neželeni učinki so navedeni po organskih sistemih MedDRA in pogostnosti.
English: Table 3: Summary of individual signs/symptoms characterising local injection site reactions in studies TORO 1 and TORO 2 combined (% of patients) n=663
Slovenian: Preglednica 3 Povzetek posameznih znakov/simptomov, značilnih za lokalne reakcije na mestu injiciranja, združenih iz študij TORO 1 in TORO 2 (% bolnikov).
English: After all of the Water for Injections has been added to the vial of Fuzeon, take out the syringe from the vial.
Slovenian: Potem ko ste v vialo zdravila Fuzeon dodali vso vodo za injekcije, injekcijsko brizgo izvlecite iz viale.
English: Injecting Water For Injections Into Fuzeon Powder
Slovenian: Vbrizganje vode za injekcije v prašek zdravila Fuzeon
English: In Vitro resistance to enfuvirtide: HIV-1 isolates with reduced susceptibility to enfuvirtide have been selected in vitro which harbour substitutions in amino acids (aa) 36-38 of the gp41 ectodomain.
Slovenian: In vitro odpornost proti enfuvirtidu: izolati HIV-1 z zmanjšano dovzetnostjo za enfuvirtid, ki imajo substitucije aminokislin (AK) 36-38 ektodomene glikoproteina 41, so bili izbrani in vitro.
English: Contents of the pack and other information Step-by-step guide to injecting Fuzeon
Slovenian: Vsebina pakiranja in dodatne informacije Navodila za injiciranje zdravila Fuzeon po korakih
English: • flu or ‘flu-like' symptoms
Slovenian: • gripa ali gripi podobni simptomi,
English: Hepatic impairment: No data are available to establish a dose recommendation for patients with hepatic impairment (see sections 4.4 and 5.2).
Slovenian: Okvara jeter: za določitev priporočil za odmerjanje zdravila Fuzeon pri bolnikih z okvaro jeter ni podatkov (glejte poglavji 4.4 in 5.2).
English: Fuzeon +Optimised background a
Slovenian: Fuzeon + optimizirano temeljno zdravljenjea
English: In clinical trials the dosage regimen in Table 1 below was used:
Slovenian: Pri kliničnih preskušanjih je bil uporabljen način odmerjanja, prikazan v preglednici 1.
English: Immune Reactivation Syndrome: 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.
Slovenian: 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.
English: Clinical Pharmacodynamic data
Slovenian: Klinični farmakodinamski podatki
English: Dispose of the vial and the Water for Injections into your special waste container with a lid - this vial is for single use only.
Slovenian: Vialo in vodo za injekcije zavrzite v vaš posebni zabojnik s pokrovom - viala je namenjena samo za enkratno uporabo.
English: Injection volume (90 mg enfuvirtide per ml)
Slovenian: Volumen injicirane raztopine (90 mg enfuvirtida na ml)
English: • This step may be repeated until the correct amount of Water for Injections is in the syringe.
Slovenian: • Ta korak lahko ponavljate, dokler ni v injekcijski brizgi ustrezne količine raztopine.
English: Check for any places where you may have a reaction by pressing the skin to see if there are any hard bumps.
Slovenian: Preverite vsa mesta injiciranja, kjer bi lahko imeli reakcijo s pritiskom na kožo, da se prepričate, da ni zatrdlin.
English: • Fuzeon is given as a 1 ml injection just below the skin - called a ‘subcutaneous' injection.
Slovenian: • Zdravilo Fuzeon dajemo kot 1-ml injekcijo tik pod kožo - imenujemo jo subkutana injekcija.
English: BL HIV-1 RNA < 5.0 log10
Slovenian: Izhodiščna HIV-1 RNA < 5,0 log10
English: - Check with your doctor, pharmacist or nurse about proper disposal of the container.
Slovenian: • Posvetujte se z vašim zdravnikom, farmacevtom ali medicinsko sestro, kako ustrezno zavreči zabojnik.
English: If there is any blood where you have given the injection, cover the skin with a sticking plaster.
Slovenian: Če je na mestu vboda kaj krvi, ga prekrijte z obližem.
English: Open syringe packs and take off vial caps.
Slovenian: Odprite ovojnino injekcijskih brizg in odstranite pokrovčke vial.
English: How Fuzeon works
Slovenian: Kako deluje zdravilo Fuzeon
English: • ear infection
Slovenian: • ušesne okužbe,
English: Do not use this medicine if you notice any particles in the powder or the solution once the water for injection has been added.
Slovenian: Ne uporabljajte tega zdravila, če ste v prašku ali raztopini po dodatku vode za injekcije opazili trdne delce.
English: - Then pull out the liquid again.
Slovenian: • Ponovno izvlecite raztopino.
English: Solvent 4 years
Slovenian: Vehikel 4 leta
English: Blood and lymphatic system disorders Common
Slovenian: Bolezni krvi in limfatičnega sistema pogosti limfadenopatija
English: Using the thumb of your other hand, press the plunger to inject the liquid.
Slovenian: S palcem druge roke pritisnite bat za injiciranje raztopine.
English: 29.1 to 33.5
Slovenian: 29,1 do 33,5
English: The proportion of patients achieving viral load of <400 copies/ml at week 48 was 30.4% among patients on the Fuzeon + OB regimen compared to 12% among patients receiving OB regimen only.
Slovenian: Delež bolnikov, ki so dosegli virusno breme < 400 kopij/ml v 48 tednih je bil 30,4 % med bolniki, zdravljenimi z zdravilom Fuzeon in optimiziranim temeljnim zdravljenjem v primerjavi z 12 % med bolniki, ki so prejemali le optimizirano temeljno zdravljenje.
English: - After the dose is fully delivered, remove the needle from the skin.
Slovenian: • Ko ste injicirali celoten odmerek, izvlecite iglo iz kože.
English: - Wipe each vial top with a fresh alcohol pad.
Slovenian: ● Obrišite zgornjo površino vsake viale z novim alkoholnim zložencem.
English: In 25 paediatric patients ranging in age from 5 to 16 years and receiving the 2 mg/kg bid dose into the upper arm, anterior thigh or abdomen, the mean steady-state AUC was 54.3 ± 23.5 µg*h/ml, Cmax was 6.14 ± 2.48 µg/ml, and Ctrough was 2.93 ± 1.55 µg/ml.
Slovenian: pediatričnih bolnikih, starih od 5 do 16 let, ki so prejemali odmerek 2 mg/kg dvakrat na dan v nadlaket, sprednjo stran stegna ali trebuh, je bila povprečna AUC v stanju dinamičnega ravnovesja 54,3 ± 23,5 µg*h/ml, Cmax je bila 6,14 ± 2,48 µg/ml in Ctrough 2,93 ± 1,55 µg/ml.
English: Read the package leaflet before use
Slovenian: Pred uporabo preberite priloženo navodilo
English: Through week 48, eosinophilia [greater than the Upper Limit of Normal of > 0.7 x 109/l] occurred at a higher rate amongst patients in the Fuzeon containing group (12.4 patients with event per 100 patient-years) compared with OB alone regimen (5.6 patients with event per 100 patient-years).
Slovenian: Eozinofilija (večja kot zgornja referenčna vrednost > 0,7 x 109/l) se je v 48. tednu pojavila v večjem deležu med bolniki v skupini, ki je prejemala zdravilo Fuzeon (12,4 bolnika z dogodkom na 100 bolnikovih let), v primerjavi z bolniki, ki so prejemali samo optimizirano temeljno zdravljenje (5,6 bolnika z dogodkom na 100 bolnikovih let).
English: What Fuzeon is and what is it used for
Slovenian: Kaj je zdravilo Fuzeon in za kaj ga uporabljamo Kaj je zdravilo Fuzeon
English: Patients should be instructed to discard the remaining volume in the solvent vials.
Slovenian: 1,1 ml. Bolnike je treba podučiti, da zavržejo preostalo količino vehikla v viali.
English: Fuzeon contains sodium Fuzeon contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free'.
Slovenian: Zdravilo Fuzeon vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: • Choose a different area from where you last injected yourself.
Slovenian: • Za vsako injiciranje izberite drugo mesto kot ste ga uporabili prejšnjič.
English: Renal impairment: No dose adjustment is required for patients with renal impairment including those receiving dialysis (see sections 4.4 and 5.2).
Slovenian: Okvara ledvic: pri bolnikih z okvaro ledvic, vključno z bolniki v programu dialize, odmerka ni treba prilagajati (glejte poglavji 4.4 in 5.2).
English: • Allergic reaction (hypersensitivity) - signs may include: rash, a high temperature or chills,
Slovenian: • alergijska reakcija (preobčutljivost) - znaki vključujejo: izpuščaj, visoko telesno temperaturo ali mrazenje, slabost ali bruhanje, potenje ali tresenje.
English: Draw back 1.1 ml of air.
Slovenian: Zajemite 1,1 ml zraka v brizgo.
English: Pancreatitis, gastro-oesophageal reflux disease
Slovenian: Bolezni prebavil pogosti pankreatitis, gastroezofagealna refluksna bolezen
English: Discontinued due to adverse reactions/intercurrent illness/labs†
Slovenian: razmerje obetov prekinitev zdravljenja zaradi neželenih učinkov/istočasna bolezen/patološka laboratorijska vrednost†
English: • hold the vial between the thumb and forefinger of your right hand.
Slovenian: • vialo s palcem in kazalcem desnice.
English: Table 4: Exposure adjusted Grade 3 & 4 laboratory abnormalities among patients on Fuzeon+OB and OB alone regimens, reported at more than 2 patients with event per 100 patient years Laboratory Parameters Grading
Slovenian: Preglednica 4 Izpostavljenosti prilagojene patološke laboratorijske vrednosti stopnje 3 in 4 pri bolnikih, ki so prejemali zdravilo Fuzeon in optimizirano temeljno zdravljenje in samo optimizirano temeljno zdravljenje, opažene pri več kot 2 bolnikih z dogodkom na 100 bolnikovih let Razvrstitev laboratorijskih parametrov
English: Then start again with a new vial of Fuzeon powder.
Slovenian: Začnite z novo vialo praška zdravila Fuzeon.
English: Fuzeon is not recommended for use in children below age 6 due to insufficient data on safety and efficacy (see section 5.2).
Slovenian: Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila Fuzeon pri otrocih pod 6 let ni priporočljiva (glejte poglavje 5.2).
English: Fuzeon + OB therapy was associated with a higher proportion of patients reaching <400 copies/ml (or <50 copies/ml) across all subgroups based on baseline CD4, baseline HIV-1 RNA, number of prior antiretrovirals (ARVs) or number of active ARVs in the OB regimen.
Slovenian: Terapija zdravila Fuzeon in optimizirano temeljno zdravljenje je bila povezana z večjim številom bolnikov, ki so dosegli < 400 kopij/ml (ali < 50 kopij/ml) med vsemi podskupinami, osnovanimi na izhodiščni vrednosti CD4, izhodiščni vrednosti HIV-1 RNA, številu predhodnih protiretrovirusnih zdravil ali številu aktivnih protiretrovirusnih zdravil v shemi z optimiziranim temeljnim zdravljenjem.
English: Sinusitis, skin papilloma, influenza, pneumonia, ear infection
Slovenian: Infekcijske in parazitske bolezni pogosti sinusitis, papilomi kože, gripa, pljučnica, ušesne okužbe
English: If you stop and there is a gap in your treatment this may speed up the chances of the HIV in your blood becoming resistant to Fuzeon.
Slovenian: Če prenehate z uporabo zdravila in v vašem zdravljenju pride do prekinitve, to lahko pospeši pojav, da postane virus
English: The mean CD4 cell count increase was greater in patients on the Fuzeon + OB regimen than in patients on OB regimen only (see Table 5).
Slovenian: Povprečni porast števila celic CD4 je bil večji pri bolnikih, ki so prejemali zdravilo Fuzeon in optimizirano temeljno zdravljenje, kot pri bolnikih, ki so prejemali samo optimizirano temeljno zdravljenje (glejte preglednico 5).
English: The syringes supplied with this medicine have a coloured needle protector.
Slovenian: Vaše injekcijske brizge Injekcijske brizge, priložene temu zdravilu, imajo obarvan pripomoček za zaščito igle.
English: Patients should be instructed on the use and administration of Fuzeon by a healthcare professional before using for the first time.
Slovenian: Pred prvo uporabo naj zdravstveni delavec bolnike pouči o uporabi in dajanju zdravila Fuzeon.
English: 20.1 to 24.5
Slovenian: 20,1 do 24,5
English: Step D: Injecting Fuzeon
Slovenian: Korak D: injiciranje zdravila Fuzeon
English: HIV RNA >1 log below Baseline**
Slovenian: Upad HIV-RNA > 1 log od izhodiščne vrednosti**
English: 6.6 Special precautions for disposal and reconstitution
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2.)
Slovenian: Predpisovanje in izdaja zdravila je le s posebnim režimom (Glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: 60 vials of Water for Injections that is used to reconstitute the Fuzeon powder 60 3 ml syringes
Slovenian: 60 vial vode za injekcije, ki se uporablja za pripravo raztopine s praškom zdravila Fuzeon, 60 3-ml injekcijskih brizg,
English: What Fuzeon looks like and contents of the pack Fuzeon powder and solvent for solution for injection comes in a carton containing:
Slovenian: Prašek in vehikel za raztopino za injiciranje zdravila Fuzeon sta v škatli, ki vsebuje:
English: Table 2: Adverse reactions attributed to treatment with Fuzeon in studies TORO 1 and TORO 2 combined
Slovenian: Preglednica 2 Neželeni učinki, ki so jih pripisali zdravljenju z zdravilom Fuzeon v kliničnih preskušanjih TORO 1 in TORO 2 skupaj
English: 38.1 to 42.5
Slovenian: 38,1 do 42,5
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and can occur many months after initiation of treatment.
Slovenian: Poročajo, da se med imunsko reaktivacijo lahko pojavijo tudi avtoimunske bolezni (kot sta Gravesova bolezen in avtoimunski hepatitis); čas do njihovega nastanka je spremenljiv, zato se lahko pojavijo tudi več mesecev po začetku zdravljenja.
English: Make sure the tip of the needle is always below the surface of the Water for Injections to help keep any air bubbles from entering the syringe.
Slovenian: Prepričajte se, da je vrh igle vedno pod gladino vode za injekcije, da preprečite vstop zračnih mehurčkov v injekcijsko brizgo.
English: Pack sizes
Slovenian: Velikost pakiranja
English: Never shake the vial or turn it upside down to mix-this will cause too much foaming.
Slovenian: Viale nikoli ne stresajte, niti je ne obračajte navzdol in navzgor, da bi premešali vsebino − to bi povzročilo čezmerno penjenje.
English: Safety results are expressed as the number of patients with an adverse reaction per 100 patientyears of exposure (except for injection site reactions).
Slovenian: bolnikovih let izpostavljenosti (razen za reakcije na mestu injiciranja).
English: Data is limited in patients with moderate to severe renal impairment, and in patients maintained on dialysis.
Slovenian: Pri bolnikih z zmerno do hudo ledvično okvaro in bolnikih, ki so v programu dialize, so na voljo le omejeni podatki.
English: Enfuvirtide also inhibited HIV-1 envelope mediated cell-cell fusion.
Slovenian: Enfuvirtid je zaviral tudi zlitje celica−celica, posredovano z ovojnico HIV-1.
English: HIV-1 RNA < 400 copies/ml
Slovenian: HIV-1 RNA < 400 kopij/ml
English: • The other ingredients are:
Slovenian: • Pomožne snovi so: Prašek:
English: Detailed information on this medicinal product is available on the web site of the European Medicines Agency: http://www.ema.europa.eu/
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: lyophilisate stopper, rubber (latex free)
Slovenian: zamašek iz gume (brez lateksa)
English: Patient demographics include a median baseline HIV-1 RNA of 5.2 log10 copies/ml and 5.1 log10 copies/ml and median baseline CD4 cell count of 88 cells/mm3 and 97 cells/mm3 for Fuzeon + OB and OB, respectively.
Slovenian: Demografski podatki bolnikov so vključevali izhodiščno mediano vrednost HIV-1 RNA 5,2 log10kopij/ml za zdravilo Fuzeon in optimizirano temeljno zdravljenje ter 5,1 log10kopij/ml za optimizirano temeljno zdravljenje, izhodiščno mediano vrednost števila celic CD4 88 celic/mm3 za zdravilo Fuzeon in optimizirano temeljno zdravljenje in 97 celic/mm3 za optimizirano temeljno zdravljenje.
English: Drawing up Fuzeon into the 1 ml syringe
Slovenian: Odvzem zdravila Fuzeon v 1-ml injekcijsko brizgo
English: Let the tops dry in the air. - Make sure you do not touch the rubber tops after cleaning them.
Slovenian: ● Poskrbite, da se gumijastih zgornjih površin po čiščenju ne dotikate.
English: It may be difficult at first to inject in some places, such as the upper arms.
Slovenian: Kdaj naj vam nekdo pomaga Na začetku je lahko težavno injicirati na nekatera mesta, kot je nadlaket.
English: A dose of 2 mg/kg bid (maximum 90 mg bid) provided enfuvirtide plasma concentrations similar to those obtained in adult patients receiving 90 mg bid dosage.
Slovenian: Plazemske koncentracije enfuvirtida pri odmerku 2 mg/kg dvakrat na dan (največji 90 mg dvakrat na dan) so bile podobne kot pri odraslih bolnikih, ki so prejemali odmerek 90 mg dvakrat na dan.
English: - After washing your hands, do not touch anything except the injection supplies and where the injection will be given.
Slovenian: ● Po umivanju rok se ne dotikajte ničesar razen potrebščin za injiciranje in mesta injiciranja.
English: Keep the vial in the outer carton in order to protect from light.
Slovenian: Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Shelf life after reconstitution
Slovenian: Rok uporabnosti po rekonstituciji
English: Powder
Slovenian: Prašek
English: HIV-1 RNA < 50 copies/ml
Slovenian: HIV-1 RNA < 50 kopij/ml
English: Each vial contains 108 mg enfuvirtide.
Slovenian: 1 viala vsebuje 108 mg enfuvirtida.
English: Make sure the tip of the needle is always below the surface of the solution to help keep air bubbles from entering the syringe.
Slovenian: Prepričajte se, da je konica igle vedno pod površino raztopine, da preprečite vstop zračnih mehurčkov v injekcijsko brizgo.
English: Hold the main part of the syringe with one hand and gently press the coloured needle protector down on a flat surface until it covers the needle.
Slovenian: Držite injekcijsko brizgo za osrednji del v eni roki in nežno pritisnite na obarvan pripomoček za zaščito igle na ravni podlagi, dokler ne pokrije igle.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: METHOD AND ROUTE(S) OF ADMINISTRATION This water for injections is intended for the reconstitution of Fuzeon 90 mg/ml powder for solution for injection to obtain a solution for subcutaneous use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Ta voda za injekcije je namenjena za pripravo raztopine za injiciranje zdravila Fuzeon 90 mg/ml prašek za raztopino za injiciranje za subkutano uporabo Pred uporabo preberite priloženo navodilo
English: - The vial can also be gently rolled between your hands after adding the Water for Injections until it is fully dissolved.
Slovenian: • Vialo lahko po dodajanju vode za injekcije tudi nežno valjate med dlanmi, dokler vsebina ni popolnoma raztopljena.
English: In clinical trials, an increased rate of some bacterial infections, most notably a higher rate of pneumonia, was seen in patients treated with Fuzeon; however, an increased risk of bacterial pneumonia related to the use of Fuzeon has not been confirmed by subsequent epidemiological data.
Slovenian: V kliničnih preskušanjih so pri bolnikih, zdravljenih z zdravilom Fuzeon opazili povišan delež nekaterih bakterijskih okužb, najbolj opazen je bil večji delež pljučnice.