FrancophonIA/ELRC3.0 huggingface dataset:
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Slovenian: Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART) nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične okužbe.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for solution
Slovenian: IME ZDRAVILA IN POT(I) UPORABE
English: When the powder begins to dissolve you can put the vial aside to allow it to completely dissolve.
Slovenian: Ko se prašek začne raztapljati, lahko vialo odložite, da se bo vsebina popolnoma raztopila.
English: Discontinued due to injection site reactions
Slovenian: prekinitev zdravljenja zaradi reakcij na mestu injiciranja
English: CD4+ cell count Change from baseline (cells/mm3)#
Slovenian: Sprememba od izhodiščne vrednosti (celic/mm3) #
English: Take out the syringe from the vial.
Slovenian: Injekcijsko brizgo izvlecite iz viale.
English: 60 vials of Fuzeon
Slovenian: 60 vial zdravila Fuzeon,
English: Tap the syringe gently to make any air bubbles rise to the top.
Slovenian: Narahlo potrkajte po injekcijski brizgi, da morebitni zračni mehurčki splavajo na vrh.
English: Dry skin, eczema seborrhoeic, erythema, acne
Slovenian: Bolezni kože in podkožja pogosti suha koža, seboroični ekcem, eritem, akne
English: Injection site reactions
Slovenian: Reakcije na mestu injiciranja
English: - If too much air enters the syringe, gently press the plunger to force the air back into the vial.
Slovenian: • Če pride v injekcijsko brizgo preveč zraka, narahlo pritisnite bat, da iztisnete zrak nazaj v vialo.
English: • pain and feeling numb in hands, feet or legs.
Slovenian: • izguba telesne mase, • bolečina in občutek otrplosti dlani, stopal ali nog.
English: • Do not inject into moles, scar tissue, bruises or your belly button (navel).
Slovenian: • Ne injicirajte v bradavice, brazgotine, modrice ali v popek.
English: SPECIAL STORAGE CONDITIONS Keep the vial in the outer carton in order to protect from light After reconstitution store in a refrigerator
Slovenian: Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo Pripravljeno raztopino shranjujte v hladilniku
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and late embryonal development.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in vpliva na pozni razvoj zarodka ne kažejo posebnega tveganja za človeka.
English: • diabetes,
Slovenian: • sladkorna bolezen,
English: ≥ 2 Active ARVs in background1,2
Slovenian: ≥ 2 aktivni protiretrovirusni zdravili v temeljni terapiji1,2
English: Once reconstituted, the solution should be injected immediately.
Slovenian: Ko je raztopina pripravljena, jo je treba nemudoma injicirati.
English: Each vial with powder also contains sodium carbonate (anhydrous), mannitol, sodium hydroxide and hydrochloric acid.
Slovenian: Viala s praškom vsebuje tudi natrijev karbonat (brezvoden), manitol, natrijev hidroksid in klorovodikovo kislino.
English: Push the syringe needle into the rubber top of the vial of Water for Injections and press the plunger.
Slovenian: Potisnite injekcijsko iglo v gumijasti zamašek viale z vodo za injekcije in pritisnite bat.
English: Each solvent vial contains 2 ml Water for Injections.
Slovenian: 1 viala z vehiklom vsebuje 2 ml vode za injekcije.
English: Gently tap the vial of Fuzeon to loosen the powder.
Slovenian: Narahlo potrkajte na vialo zdravila Fuzeon, da zrahljate prašek.
English: - The powder may take up to 45 minutes to dissolve into solution.
Slovenian: • Da se prašek raztopi, lahko traja do 45 minut.
English: - This may reduce the time it takes for the powder to dissolve.
Slovenian: • To lahko skrajša čas za popolno raztopitev praška.
English: Do not use this medicine after the expiry date which is stated on the label of either the Fuzeon or the Water for Injections Vials after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki vial zdravila Fuzeon ali vode za injekcije poleg oznake Uporabno do. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: • If you have any further questions, ask your doctor, pharmacist or nurse.
Slovenian: • Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: In a renal impairment study AUC of enfuvirtide was increased on average by 43-62% in patients with severe or end stage renal disease compared to patients with normal renal function.
Slovenian: 43 - 62 % v primerjavi z bolniki z normalno ledvično funkcijo.
English: If you have any questions or concerns about the safe disposal of these materials, please talk to your doctor, pharmacist or nurse.
Slovenian: Če imate kakršna koli vprašanja o varnem odstranjevanju teh predmetov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: - If the bubbles are still there, gently tap the side of the vial to help settle them.
Slovenian: • Če so v viali še vedno mehurčki, narahlo potrkajte na steno viale, da bodo lažje izplavali.
English: The powder may take up to 45 minutes to dissolve into solution.
Slovenian: Da se prašek popolnoma raztopi v raztopini, lahko traja do 45 minut.
English: Get the following things together: - One vial of Fuzeon (glass container with white powder inside) - One vial of Water for Injections (glass container with clear and colourless liquid inside) - One 3 ml syringe (larger syringe) with a 25 mm needle - One 1 ml syringe (smaller syringe) with a 13 mm needle - Three alcohol swabs - Special waste container with a lid for the safe disposal of the waste materials.
Slovenian: ● eno vialo vode za injekcijo (stekleni vsebnik z bistro in brezbarvno tekočino) ● eno 3 ml injekcijsko brizgo (večja injekcijska brizga) s 25 mm injekcijsko iglo
English: • This medicine has been prescribed for you only.
Slovenian: • Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: Closure:
Slovenian: Zamašek:
English: Pick up the 3 ml large syringe.
Slovenian: Vzemite veliko, 3-ml injekcijsko brizgo.
English: 60 1 ml syringes
Slovenian: 60 1-ml injekcijskih brizg,
English: When the needle is in: - release the skin - use this free hand to hold on to the main part of the syringe - this will help steady it and stop it from moving.
Slovenian: • s to prosto roko primite osrednji del injekcijske brizge - tako jo lažje držite pri miru in preprečite premikanje.
English: • redness of the skin
Slovenian: • pordela koža,
English: 27 May 2008
Slovenian: Datum zadnjega podaljšanja: 27. maj 2008
English: Each vial also contains sodium carbonate (anhydrous), mannitol, sodium hydroxide and hydrochloric acid.
Slovenian: Viala vsebuje tudi natrijev karbonat (brezvoden), manitol, natrijev hidroksid in klorovodikovo kislino.
English: To reduce the risk of infection, it is important that you follow the instructions provided in Section 7.
Slovenian: Pomembno je, da se ravnate po navodilih v poglavju
English: BL HIV-1 RNA ≥ 5.0
Slovenian: Izhodiščna HIV-1 RNA ≥ 5,0 log10
English: cGrade 3= ≥ 50 mm but < 85 mm average diameter; Grade 4= ≥ 85 mm average diameter.
Slovenian: cStopnja 3 = povprečni premer ≥ 50 mm, toda < 85 mm; stopnja 4 = povprečni premer ≥ 85 mm. dStopnja 3 = povprečni premer ≥ 25 mm, toda < 50 mm; stopnja 4 = povprečni premer ≥ 50 mm. eStopnja 3 = ≥ 3 cm; stopnja 4 = če izceja.
English: Roche Norge AS Tlf: +47 - 22 78 90 00
Slovenian: Tlf: +47 - 22 78 90 00
English: Fuzeon can cause a build-up of a type of protein, called amyloid, under the skin at the injection site.
Slovenian: Zdravilo Fuzeon lahko pod kožo na mestu injiciranja povzroči kopičenje vrste beljakovine, imenovane amiloid.
English: severe pain requiring hospitalisation or prolongation of hospitalisation, resulting in death, or persistent or significant disability/incapacity, or life-threatening, or medically significant.
Slovenian: bStopnja 3 = huda bolečina, ki zahteva analgetike (ali narkotične analgetike za ≤ 72 ur) in/ali omejuje običajne aktivnosti; stopnja 4 = huda bolečina, ki zahteva hospitalizacijo ali podaljšanje hospitalizacije, povzroči smrt ali trajno ali pomembno nezmožnost/nesposobnost, ali ogroža življenje ali je zdravstveno pomembna.
English: Hepatic impairment: The pharmacokinetics of enfuvirtide have not been studied in patients with hepatic impairment.
Slovenian: Jetrna okvara: farmakokinetike enfuvirtida pri bolnikih z oslabljenim delovanjem jeter niso proučevali.
English: - Let the liquid get back to room temperature before using.
Slovenian: • Pred uporabo pustite, da se raztopina ogreje na sobno temperaturo.
English: Other adverse reactions
Slovenian: Drugi neželeni učinki
English: • inflamed eye (conjunctivitis)
Slovenian: • otečene žleze (bezgavke), • vnetje očesne veznice (konjunktivitis),
English: Very common (affects more than 1 in 10 people)
Slovenian: Drugi možni neželeni učinki Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
English: Powder Vial:
Slovenian: Viala:
English: Sodium hydroxide Hydrochloric Acid
Slovenian: Prašek natrijev karbonat manitol natrijev hidroksid klorovodikova kislina
English: Talk to your doctor, pharmacist or nurse before using Fuzeon if:
Slovenian: Pred začetkom uporabe zdravila Fuzeon se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če:
English: • kidney stones
Slovenian: • ledvični kamni,
English: What Fuzeon contains
Slovenian: Kaj vsebuje zdravilo Fuzeon
English: • tighten the needle and cap by slightly turning and pushing it towards the syringe.
Slovenian: • iglo s pokrovom pritrdite z rahlim obratom in potiskanjem proti injekcijski brizgi.
English: Water for Injections
Slovenian: voda za injekcije.
English: - Keep the cover of this container tight and keep it out of the reach of children.
Slovenian: • Pokrov zabojnika mora biti tesno zaprt, zabojnik pa shranjen na mestu, nedosegljivem otrokom.
English: 1 ml of the reconstituted solution should be injected subcutaneously in to the upper arm, abdomen or anterior thigh.
Slovenian: 1 ml pripravljene raztopine injiciramo subkutano v nadlaket, trebuh ali sprednjo stran stegna.
English: Wipe the top of the Fuzeon vial again with a new alcohol swab.
Slovenian: Ponovno obrišite pokrov viale zdravila Fuzeon z novim alkoholnim zložencem.
English: Pick up the 1 ml small syringe.
Slovenian: Vzemite malo, 1-ml injekcijsko brizgo.
English: Respiratory, thoracic and mediastinal disorders Common
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti nazalna kongestija
English: Each ml of reconstituted solution contains 90 mg enfuvirtide.
Slovenian: Vsak ml pripravljene raztopine vsebuje 90 mg enfuvirtida.
English: OB (N=334)
Slovenian: optimizirano temeljno zdravljenje (n = 334)
English: Weight decreased Influenza like illness, asthenia c. Description of selected adverse reactions
Slovenian: Splošne težave in spremembe na mestu aplikacije zelo pogosti pogosti zmanjšanje telesne mase bolezen podobna gripi, astenija c. Opis izbranih neželenih učinkov
English: Mean (± SD) Cmax was 4.59 ± 1.5 µg/ml, AUC was 55.8 ± 12.1 µg*hr/ml The subcutaneous absorption of enfuvirtide is proportional to the administered dose over the 45 to 180 mg dose range.
Slovenian: Povprečna (± SD) Cmax je bila 4,59 ± 1,5 µg/ml, AUC je bila 55,8 ± 12,1 µg*ur/ml.
English: Appetite decreased, anorexia, hypertriglyceridaemia, blood triglycerides increased, diabetes mellitus
Slovenian: Presnovne in prehranske motnje pogosti zmanjšan apetit, anoreksija, hipertrigliceridemija, sladkorna bolezen
English: Do not use too much force as the needle may loosen.
Slovenian: Ne uporabite preveč sile,
English: 0 Active ARVs in background1,2
Slovenian: 0 aktivnih protiretrovirusnih zdravil v temeljni terapiji1,2
English: • feeling weak
Slovenian: • občutek šibkosti,
English: Do this in a circular motion, starting in the middle and working outward.
Slovenian: To storite s krožnimi gibi najprej na mestu injiciranja in nato v spirali navzven.
English: Press the syringe plunger in slowly.
Slovenian: Počasi pritiskajte bat injekcijske brizge.
English: Before the solution is withdrawn for administration, the patient should inspect the vial visually to ensure that the contents are fully in solution, and that the solution is clear and without bubbles or particulate matter.
Slovenian: Pred odvzemom raztopine za dajanje naj bolnik pregleda vialo, da se zagotovi, da je vsebina popolnoma raztopljena,
English: Fuzeon is only to be administered by subcutaneous injection.
Slovenian: Zdravilo Fuzeon dajemo samo kot subkutano injekcijo.
English: aluminium seal with flip-off cap
Slovenian: aluminijast pokrov z zaporko, ki se sproži
English: No dose adjustment is required for patients with impaired renal function.
Slovenian: Pri bolnikih z okvaro ledvične funkcije prilagajanje odmerkov ni potrebno.
English: 1 ml of reconstituted solution contains 90 mg of enfuvirtide.
Slovenian: 1 ml pripravljene raztopine vsebuje 90 mg enfuvirtida.
English: Push the syringe needle into the rubber top of the Fuzeon vial and press the plunger.
Slovenian: Potisnite injekcijsko iglo v gumijasti zamašek viale zdravila Fuzeon in pritisnite bat.
English: 1 Active ARV in background1,2
Slovenian: 1 aktivno protiretrovirusno zdravilo v temeljni terapiji1,2
English: Solvent Vial:
Slovenian: Vehikel:
English: Draw Up Water for Injections
Slovenian: Odvzemite vodo za injekcije
English: The highest dose administered to 12 patients in a clinical trial was 180 mg as a single dose subcutaneously.
Slovenian: Največji odmerek, dan podkožno kot posamezni odmerek 12 bolnikom v kliničnem preskušanju, je bil 180 mg. Ti bolniki niso izkusili nobenih neželenih učinkov, ki niso bili opaženi s priporočenim odmerkom.
English: - If you see any bits in the liquid, do not use it. - Dispose of the vial into the special waste container with a lid or return it to the pharmacy.
Slovenian: • Vialo zavrzite v vsebnik za odpadne snovi s pokrovom ali pa jo vrnite v lekarno.
English: Hold the main part of the water-filled syringe and push the needle through the rubber top of the vial at a slight angle.
Slovenian: Injekcijsko brizgo, napolnjeno z vodo, držite za osrednji del in potisnite iglo narahlo pod kotom skozi gumijasti zamašek viale.
English: - Dispose of all used items straight into the special waste container with a lid. Do this even if the vials contain unused amounts of medicine or Water for Injections as these are for single use only.
Slovenian: To storite tudi z vialami, ki še vsebujejo neporabljeno količino zdravila ali vode za injekcije, ker so le za enkratno uporabo.
English: What you need to know before you use Fuzeon
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Fuzeon Ne jemljite zdravila Fuzeon, če
English: Using your index finger, move the coloured needle protector away from the needle.
Slovenian: S pomočjo kazalca potisnite obarvan pripomoček za zaščito igle proč od injekcijske igle.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING IMMEDIATE OUTER CARTON FOR WATER FOR INJECTIONS VIALS
Slovenian: PODATKI NA PRIMARNI OVOJNINI PRIMARNA ZUNANJA OVOJNINA ZA VIALE Z VODO ZA INJEKCIJE
English: feeling or being sick, sweating or shaking.
Slovenian: • bolečina, občutek razbolelosti ali občutljivost.
English: Musculoskeletal, connective tissue and bone disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti mialgija
English: Τηλ: +30 210 61 66 100
Slovenian: Roche (Hellas) A.E. Τηλ: +30 210 61 66 100
English: Absorption: The absolute bioavailability after subcutaneous administration of enfuvirtide 90 mg in the abdomen was 84.3 ± 15.5%.
Slovenian: Absorpcija: absolutna biološka uporabnost po subkutanem dajanju 90 mg enfuvirtida v trebuh je bila
English: • If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: • Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: After the powder begins to dissolve they can set the vial aside to allow it to completely dissolve.
Slovenian: Po tem ko se prašek začne raztapljati, lahko vialo odložijo, da se prašek popolnoma raztopi.
English: How to store Fuzeon
Slovenian: Shranjevanje zdravila Fuzeon
English: Fuzeon must be given as an injection just below the skin - called a ‘subcutaneous' injection.
Slovenian: Kako pripraviti in injicirati zdravilo Fuzeon Zdravilo Fuzeon je treba dati kot injekcijo tik pod kožo - subkutana injekcija.
English: Log Change from baseline (log10 copies/ml)*
Slovenian: HIV-1 RNA log spremembe od izhodiščne vrednosti (log10kopij/ml)*
English: Table 1: Paediatric Dosing Weight (kg)
Slovenian: Telesna masa (kg)
English: 4 It is important to check the liquid for bits (particles).
Slovenian: Pomembno je, da pregledate videz raztopine, ali vsebuje trdne delce.
English: Table 2 presents events seen at a higher rate among patients receiving Fuzeon + OB regimen than among patients on the OB alone regimen with an exposure adjusted increase of at least 2 patients with event per 100 patient-years.
Slovenian: Navedeni so tisti s povečanjem, korigiranim glede na izpostavljenost, za vsaj 2 bolnika z dogodkom na 100 bolnikovih let.
English: ● hardened skin or bumps
Slovenian: • modrice, • zatrdela koža ali izbokline,
English: Posology
Slovenian: Kύπρος
English: 60 vials powder for solution for injection 60 vials solvent
Slovenian: 60 vial praška za raztopino za injiciranje 60 vial vehikla
English: Throw away the syringe into the special waste container with a lid.
Slovenian: Injekcijsko brizgo zavrzite v za to določeni zabojnik za odpadke s pokrovom.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING IMMEDIATE OUTER CARTON FOR FUZEON VIALS
Slovenian: PODATKI NA PRIMARNI OVOJNINI PRIMARNA ZUNANJA OVOJNINA ZA VIALE FUZEON
English: PHARMACEUTICAL FORM Powder and solvent for solution for injection.
Slovenian: Prašek in vehikel za raztopino za injiciranje.
English: ● swelling
Slovenian: • zgaga,
English: Hold the main part of the syringe with one hand - then gently press the coloured needle protector down on a flat surface until it covers the needle.
Slovenian: • nato nežno pritisnite na obarvani pripomoček za zaščito igle na ravni podlagi, dokler ne pokrije igle.
English: OB alone regimen Per 100 patient years n (Total Exposure patient years) ALAT Gr. 3 (>5-10 x ULN) Gr. 4 (>10 x ULN) Haemoglobin Gr. 3 (6.5-7.9 g/dL) Gr. 4 (<6.5 g/dL) Creatinine phosphokinase Gr. 3 (>5-10 x ULN) Gr. 4 (>10 x ULN)
Slovenian: stopnja 4 (< 6,5 g/dl) kreatinin fosfokinaza stopnja 3 (> 5-10 x zgornja referenčna vrednost)
English: METHOD OF ADMINISTRATION Read the package leaflet before use
Slovenian: za subkutano uporabo Pred uporabo preberite priloženo navodilo
English: Powder and solvent for solution for injection
Slovenian: prašek in vehikel za raztopino za injiciranje
English: log10
Slovenian: Pri 25
English: Subcutaneous absorption at the 90 mg dose is comparable when injected into abdomen, thigh or arm.
Slovenian: Absorpcija enfuvirtida po subkutanem dajanju je sorazmerna danemu odmerku v razponu odmerkov od 45 do 180 mg. Absorpcija odmerka 90 mg po subkutanem dajanju je primerljiva pri injiciranju v abdomen, stegno ali nadlaket.
English: Roche Nederland B.V. Tel: +31 (0) 348 438050
Slovenian: Tel: +31 (0) 348 438050
English: Roche s. r. o. Tel: +420 - 2 20382111
Slovenian: Tel: +420 - 2 20382111
English: Fuzeon+OB regimen Per 100 patient years
Slovenian: Fuzeon + optimizirano temeljno zdravljenje na 100 bolnikovih let samo optimizirano temeljno zdravljenje na 100 bolnikovih let n
English: 60 vials with powder for solution for injection 60 vials with solvent
Slovenian: 60 vial s praškom za raztopino za injiciranje 60 vial z vehiklom
English: * Based on results from pooled data of TORO 1 and TORO 2 on ITT population, week 48 viral load for subjects who were lost to follow-up, discontinued therapy, or had virological failure replaced by their last observation (LOCF).
Slovenian: Pri posameznikih, ki v 48. tednu niso bili spremljani, so terapijo prekinili ali imeli virološki neuspeh, je bilo virusno breme zamenjano z vrednostjo zadnje meritve (zadnja vrednost prenesena naprej - LOCF - last value carried forward).
English: Mixing the Water for Injections with the Fuzeon Powder
Slovenian: Mešanje vode za injekcije s praškom zdravila Fuzeon 1.
English: Laboratory abnormalities
Slovenian: Patološke laboratorijske vrednosti
English: If you get anyside effects, talk to your doctor, pharmacist or nurse.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA
English: If you feel dizzy while using Fuzeon do not drive or use any tools or machines.
Slovenian: Ne vozite in ne uporabljajte orodij ali upravljajte strojev, če se med prejemanjem zdravila Fuzeon počutite omotični.
English: ARVs in their OB regimen were more likely to achieve a HIV-1 RNA of <400 copies/ml (or <50 copies/ml) on either treatment (see Table 6).
Slovenian: HIV-1 RNA < 5,0 log kopij/ml, z ≤ 10 predhodnimi protiretrovirusnimi zdravili in/ali drugimi aktivnimi protiretrovirusnimi zdravili v shemi optimiziranega temeljnega zdravljenja, verjetneje dosegli HIV-1 RNA < 400 kopij/ml (ali < 50 kopij/ml) (glejte preglednico 6).
English: ● redness
Slovenian: • neješčnost,
English: Vertigo
Slovenian: Vehikel
English: Withdrawal Rate due to ISRs Event Category
Slovenian: Delež prenehanja zdravljenja zaradi lokalnih interakcij na mestu injiciranja
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi Zdravilo Fuzeon je treba jemati kot del kombiniranega režima zdravljenja.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FUZEON VIAL LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: NAME OF THE MEDICINAL PRODUCT Solvent for solution
Slovenian: NAČIN IZDAJANJA ZDRAVILA Izdaja zdravila je le na recept
English: ● bruises
Slovenian: • oteklina,
English: Method of Administration
Slovenian: Način uporabe
English: 6.1 List of excipients
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi
English: • feeling sick
Slovenian: • občutek srbenja,
English: Clean the tops of the vials.
Slovenian: Očistite zgornjo površino vial.
English: Adverse reaction
Slovenian: Neželeni učinek
English: Conjunctivitis
Slovenian: Odmerjanje
English: Solvent Water for Injections
Slovenian: Vehikel voda za injekcije
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom: België/Belgique/Belgien N.V.
English: NA
Slovenian: Pri
English: Ecchymosis g g aAny severity grade.
Slovenian: stopnje bolečina/neugodje b b rdečina c c zatrdlina d d vozliči in ciste e e srbenje f ni na voljo ehkimoza g g aKatera koli stopnja resnosti.
English: Treatment Difference
Slovenian: razmerje obetov
English: 180 alcohol swabs
Slovenian: ● tri alkoholne zložence
English: Fuzeon 90 mg/ml powder and solvent for solution for injection Enfuvirtide
Slovenian: Fuzeon 90 mg/ml prašek za raztopino za injiciranje enfuvirtid
English: • Keep using your medicine until your doctor tells you to stop.
Slovenian: Če ste prenehali uporabljati zdravilo Fuzeon • Zdravilo uporabljajte tako dolgo, dokler vam tako svetuje vaš zdravnik.
English: • decreased sensation
Slovenian: • občutek slabosti,
English: After the powder has dissolved completely - Let any bubbles that may have formed settle.
Slovenian: • pustite, da mehurčki, ki so morda nastali, popolnoma izginejo.
English: EXP
Slovenian: Izidi