FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Udio bolesnika koji su u 48. tjednu postigli virusno opterećenje od < 400 kopija/ml iznosio je 30,4% u bolesnika koji su primali Fuzeon + OT u usporedbi s 12% u bolesnika koji su primali samo OT.
English: Treatment Difference
Croatian: Razlika između režima liječenja
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.
Croatian: Pazite da se vrh igle uvijek nalazi ispod površine vode za injekcije kako mjehurići zraka ne bi ušli u štrcaljku.
English: Let the tops dry in the air. - Make sure you do not touch the rubber tops after cleaning them.
Croatian: - Pazite da ne dodirnete gumene vrhove nakon što ste ih očistili.
English: D-79639 Grenzach-Wyhlen Germany
Croatian: D-79639 Grenzach-Wyhlen Njemačka
English: Combination studies of enfuvirtide with representative members of the various antiretroviral classes exhibited additive to synergistic antiviral activities and an absence of antagonism.
Croatian: Ispitivanja kombiniranog liječenja enfuvirtidom i odabranim predstavnicima različitih skupina antiretrovirusnih lijekova pokazala su aditivno do sinergijsko antivirusno djelovanje te nepostojanje antagonizma.
English: Tap the syringe gently to make any air bubbles rise to the top.
Croatian: Nježno kucnite po štrcaljki da se mjehurići zraka dignu na vrh.
English: Specific single substitutions at these residues in gp41 each resulted in a range of decreases from baseline in recombinant viral susceptibility to enfuvirtide.
Croatian: Svaka specifična pojedinačna supstitucija na tim mjestima glikoproteina 41 dovela je do smanjenja osjetljivosti rekombinantnog virusa na enfuvirtid u različitom rasponu od početne vrijednosti.
English: Clean the area for injection well with an alcohol swab.
Croatian: Područje u koje ćete injicirati dobro očistite vatom natopljenom alkoholom.
English: - If the bubbles are still there, gently tap the side of the vial to help settle them.
Croatian: - Ako i dalje ima mjehurića, nježno lupkajte po stijenci bočice kako bi se lakše slegli.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: 995 patients comprised the intent-to-treat population.
Croatian: Populacija koju se namjeravalo liječiti (engl. intentto-treat, ITT) obuhvaćala je 995 bolesnika.
English: 20.1 to 24.5
Croatian: 20,1 do 24,5
English: - If too much air enters the syringe, gently press the plunger to force the air back into the vial.
Croatian: Ako je u štrcaljku ušlo previše zraka, nježno pritisnite klip da zrak istisnete nazad u bočicu.
English: 38.1 to 42.5
Croatian: 38,1 do 42,5
English: Contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Croatian: Sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
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.
Croatian: U nekih bolesnika s uznapredovalom HIV infekcijom (SIDA) koji su već imali oportunističke infekcije mogu se ubrzo nakon početka primjene lijeka protiv HIV-a pojaviti znakovi i simptomi upale od prijašnjih infekcija.
English: The following is a basic, step-by-step guide to injecting your medicine.
Croatian: U nastavku slijede jednostavne upute korak-po-korak za injiciranje lijeka.
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.
Croatian: Nakon dodavanja vode za injekcije bolesnik može nježno kotrljati bočicu između dlanova do potpunog otapanja, što može smanjiti vrijeme potrebno da se prašak otopi.
English: Fuzeon has not been tested for its effect on your ability to drive a car or use tools or machines.
Croatian: Nije ispitan učinak lijeka Fuzeon na sposobnost upravljanja vozilima, rukovanja alatima ili rada sa strojevima.
English: Step D: Injecting Fuzeon
Croatian: Korak D: Injiciranje lijeka Fuzeon
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.
Croatian: Oštećenje bubrežne funkcije: Analiza podataka o koncentraciji u plazmi bolesnika u kliničkim ispitivanjima pokazala je da nema klinički značajnog Analiza podataka o koncentraciji u plazmi bolesnika u kliničkim ispitivanjima pokazala je da nema klinički značajnog utjecaja na klirens enfuvirtida u bolesnika s blagim do umjerenim oštećenjem bubrežne funkcije.
English: 1 ml of the reconstituted solution should be injected subcutaneously in to the upper arm, abdomen or anterior thigh.
Croatian: 1 ml rekonstituirane otopine treba primijeniti supkutanom injekcijom u nadlakticu, trbuh ili prednju stranu bedra.
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.
Croatian: . 10. Bacite bočicu i vodu za injekcije u poseban spremnik za otpad s poklopcem - ta je bočica namijenjena samo za jednokratnu uporabu.
English: If you have any questions or concerns about the safe disposal of these materials, please talk to your doctor, pharmacist or nurse.
Croatian: U slučaju bilo kakvih pitanja ili zabrinutosti u vezi sa sigurnim odlaganjem ovih materijala, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
English: • Do not inject into moles, scar tissue, bruises or your belly button (navel).
Croatian: • Ne smijete injicirati u madeže, ožiljke, modrice niti u pupak
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.
Croatian: Jednom rukom držite glavni dio štrcaljke te obojanim štitnikom igle nježno pritisnite na ravnu površinu dok štitnik ne prekrije iglu.
English: After all of the Water for Injections has been added to the vial of Fuzeon, take out the syringe from the vial.
Croatian: Nakon što ste u bočicu lijeka Fuzeon dodali cijelu količinu vode za injekcije, izvadite štrcaljku iz bočice.
English: Wipe the top of the Fuzeon vial again with a new alcohol swab.
Croatian: Ponovno prebrišite vrh bočice lijeka Fuzeon novom vatom natopljenom alkoholom.
English: Drawing up Fuzeon into the 1 ml syringe
Croatian: Uvlačenje lijeka Fuzeon u štrcaljku volumena 1 ml 1.
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.
Croatian: Uhvatite glavni dio štrcaljke s vodom za injekcije i gurnite iglu kroz gumeni vrh bočice pod malim kutom.
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.
Croatian: U bolesnika zaraženih HIV-om s izraženom imunodeficijencijom u trenutku uvođenja kombinirane antiretrovirusne terapije može se razviti upalna reakcija na asimptomatske ili rezidualne oportunističke infekcije.
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.
Croatian: Pazite da se vrh igle uvijek nalazi ispod površine otopine kako mjehurići zraka ne bi ušli u štrcaljku.
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).
Croatian: Prijavljeni su i autoimuni poremećaji (poput Gravesove bolesti i autoimunog hepatitisa); međutim, prijavljeno vrijeme do nastupa se razlikuje i ti se događaji mogu javiti i više mjeseci nakon započinjanja liječenja
English: Very common (affects more than 1 in 10 people)
Croatian: Vrlo često (javljaju se u više od 1 na 10 osoba) • proljev
English: Laboratory abnormalities
Croatian: Laboratorijska odstupanja
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.
Croatian: Bolesnici s kroničnim hepatitisom B ili C koji se liječe antiretrovirusnim lijekovima izloženi su povećanom riziku za razvoj teških jetrenih nuspojava, s mogućim smrtnim ishodom.
English: The powder may take up to 45 minutes to dissolve into solution.
Croatian: Za potpuno otapanje praška može biti potrebno do 45 minuta.
English: Section 7 tells you how to prepare Fuzeon and how to give yourself an injection.
Croatian: U dijelu 7. daju se upute za pripremu lijeka Fuzeon i samostalno injiciranje.
English: Injection site reactions
Croatian: Reakcije na mjestu injekcije
English: rubber stopper (latex free)
Croatian: gumeni čep (bez lateksa)
English: lyophilisate stopper, rubber (latex free)
Croatian: liofilizacijski čep, gumeni (bez lateksa)
English: What Fuzeon is used for
Croatian: Za što se Fuzeon koristi
English: - The powder may take up to 45 minutes to dissolve into solution.
Croatian: - Za potpuno otapanje praška može biti potrebno do 45 minuta.
English: Take out the needle from the vial.
Croatian: 9. Izvadite iglu iz bočice.
English: Press the syringe plunger in slowly.
Croatian: Polagano potiskujte klip štrcaljke.
English: Musculoskeletal, connective tissue and bone disorders
Croatian: Poremećaji mišićno-koštanog sustava, vezivnog tkiva i kostiju često mialgija
English: Hepatic impairment: The pharmacokinetics of enfuvirtide have not been studied in patients with hepatic impairment.
Croatian: Oštećenje jetrene funkcije: Farmakokinetika enfuvirtida nije ispitivana u bolesnika s oštećenjem jetre.
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
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Roche Pharma AG, Emil-Barrell-Str.
English: • If you have any further questions, ask your doctor, pharmacist or nurse.
Croatian: • Ako imate dodatnih pitanja, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
English: Enfuvirtide also inhibited HIV-1 envelope mediated cell-cell fusion.
Croatian: Enfuvirtid je također inhibirao i fuziju stanica-stanica posredovanu ovojnicom virusa HIV-1.
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.
Croatian: - tom slobodnom rukom prihvatite glavni dio štrcaljke - tako ćete je umiriti i spriječiti pomicanje.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA
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.
Croatian: Demografske karakteristike bolesnika koji su primali Fuzeon + OT uključuju medijan početne HIV-1 RNK od 5,2 log10 kopija/ml te medijan početnog broja CD4 stanica od 88 stanica/mm3, a bolesnika koji su primali samo OT medijan početne HIV-1 RNK od 5,1 log10 kopija/ml i medijan početnog broja CD4 stanica od 97 stanica/mm3.
English: Gently tap the vial of Fuzeon to loosen the powder.
Croatian: Nježno lupkajte bočicu lijeka Fuzeon da rastresete prašak.
English: Never shake the vial or turn it upside down to mix-this will cause too much foaming.
Croatian: Nikada nemojte tresti niti preokretati bočicu kako bi se sadržaj promiješao - to će uzrokovati prekomjerno pjenjenje.
English: Water for Injections
Croatian: Otapalo voda za injekcije
English: Subcutaneous absorption at the 90 mg dose is comparable when injected into abdomen, thigh or arm.
Croatian: Usporediva je apsorpcija enfuvirtida nakon supkutane primjene doze od 90 mg u trbuh, bedro ili nadlakticu.
English: Dry skin, eczema seborrhoeic, erythema, acne
Croatian: Poremećaji kože i potkožnog tkiva često suha koža, seboroični ekcem, eritem, akne
English: • you have ever had any kidney problems
Croatian: • ako ste ikada imali tegoba s bubrezima
English: Throw away the syringe into the special waste container with a lid.
Croatian: Bacite štrcaljku u poseban spremnik za otpad s poklopcem.
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.
Croatian: Nemojte primijeniti ovaj lijek ako nakon dodavanja vode za injekcije primijetite čestice u prašku ili otopini.
English: • tighten the needle and cap with a gentle clockwise twist.
Croatian: • učvrstite iglu i kapicu nježnim zavrtanjem u smjeru kazaljke na satu.
English: The pharmacokinetic properties of enfuvirtide have been evaluated in HIV-1-infected adult and paediatric patients.
Croatian: 5.2 Farmakokinetička svojstva Farmakokinetička svojstva enfuvirtida ispitana su u odraslih i pedijatrijskih bolesnika zaraženih
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.
Croatian: Prosječni (± SD) Cmax bio je 4,59 ± 1,5 µg/ml, a AUC je bio 55,8 ± 12,1 µg*hr/ml.
English: - The vial can also be gently rolled between your hands after adding the Water for Injections until it is fully dissolved.
Croatian: - Bočicu nakon dodavanja vode za injekcije možete i nježno kotrljati između dlanova dok se sadržaj potpuno ne otopi.
English: The remaining Water for Injections in the solvent vial after withdrawal of the 1.1 ml required for reconstitution has to be discarded
Croatian: Potrebno je odbaciti vodu za injekcije koja preostane u bočici s otapalom nakon što se izvuče 1,1 ml potreban za pripremu otopine za primjenu
English: When the powder begins to dissolve you can put the vial aside to allow it to completely dissolve.
Croatian: Kad se prašak počne otapati, možete odložiti bočicu dok se potpuno ne otopi.
English: After reconstitution with the solvent provided 1 ml of reconstituted solution contains 90 mg enfuvirtide.
Croatian: Nakon pripreme za primjenu s priloženim otapalom, 1 ml pripremljene otopine sadrži 90 mg enfuvirtida.
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.)
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2)
English: Discontinued due to adverse reactions/intercurrent illness/labs†
Croatian: Prekinuli liječenje zbog nuspojava/istodobne druge bolesti/odstupanja laboratorijskih nalaza† Prekinuli liječenje zbog reakcija na mjestu injiciranja†
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).
Croatian: U većine bolesnika tijekom ispitivanja nije došlo do promjene stupnja toksičnosti bilo kojeg laboratorijskog parametra, osim onih navedenih u Tablici 4. Do 48. tjedna eozinofilija [vrijednosti > 0,7 x 109/l iznad gornje granice normale (GGN)] se javljala s većom stopom u bolesnika u skupini koja je primala Fuzeon (12,4 bolesnika s nuspojavom na 100 bolesnik-godina) u usporedbi s bolesnicima koji su primali samo OT (5,6 bolesnika s nuspojavom na 100 bolesnik-godina).
English: How to store Fuzeon
Croatian: Kako primjenjivati Fuzeon
English: For instructions on reconstitution before administration, see section 6.6.
Croatian: Za uputu o rekonstituciji lijeka prije primjene, vidjeti dio 6.6. 4.3 Kontraindikacije
English: Pancreatitis, gastro-oesophageal reflux disease
Croatian: Poremećaji probavnog sustava često pankreatitis, gastroezofagealna refluksna bolest
English: Each vial contains 108 mg enfuvirtide.
Croatian: Jedna bočica sadrži 108 mg enfuvirtida.
English: System organ class Frequency
Croatian: Organski sustav Učestalost
English: 4 It is important to check the liquid for bits (particles).
Croatian: Važno je da provjerite sadrži li tekućina čestice.
English: Ear and labyrinth disorders Common
Croatian: Poremećaji uha i labirinta često vrtoglavica
English: What you need to know before you use Fuzeon
Croatian: Što morate znati prije nego počnete primjenjivati Fuzeon Nemojte primjenjivati Fuzeon:
English: Push the syringe needle into the rubber top of the Fuzeon vial and press the plunger.
Croatian: 6. Gurnite iglu štrcaljke u gumeni vrh bočice s lijekom Fuzeon i pritisnite klip.
English: Push the syringe needle into the rubber top of the vial of Water for Injections and press the plunger.
Croatian: 5. Gurnite iglu štrcaljke u gumeni vrh bočice s vodom za injekcije i pritisnite klip.
English: Pack sizes
Croatian: Veličine pakiranja
English: Decrease in viral sensitivity was correlated to the degree of pre-treatment resistance to background therapy.
Croatian: Smanjenje osjetljivosti virusa bilo je razmjerno stupnju rezistencije na osnovnu terapiju prije uvođenja enfuvirtida (vidjeti Tablicu 6).
English: Fuzeon+OB regimen Per 100 patient years
Croatian: na 100 bolesnik-godina režim samo OT na 100 bolesnik-godina n
English: 60 3 ml syringes
Croatian: 60 štrcaljki volumena 3 ml
English: STEP-BY-STEP GUIDE TO INJECTING FUZEON
Croatian: VODIČ KORAK PO KORAK ZA INJICIRANJE LIJEKA FUZEON
English: After the powder begins to dissolve they can set the vial aside to allow it to completely dissolve.
Croatian: Nakon što se prašak počne otapati mogu odložiti bočicu dok se potpuno ne otopi.
English: After the powder has dissolved completely - Let any bubbles that may have formed settle.
Croatian: - Pričekajte da se slegnu svi mjehurići koji su se možda stvorili.
English: • eczema
Croatian: • ekcem
English: ≥ 2 Active ARVs in background1,2
Croatian: ≥ 2 aktivna antiretrovirusna lijeka u osnovnoj terapiji
English: Once reconstituted, the solution should be injected immediately.
Croatian: Nakon rekonstitucije otopinu treba odmah injicirati.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS WATER FOR INJECTIONS VIAL LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA BOČICE S VODOM ZA INJEKCIJE
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.
Croatian: U rasponu koncentracija u plazmi od 2 do 10 µg/ml 92% enfuvirtida se veže na proteine u plazmi zaraženoj HIV-om.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for solution
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA
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.
Croatian: Eliminacija: Klirens enfuvirtida nakon intravenske primjene doze od 90 mg bio je 1,4 ± 0,28 l/h, a poluvrijeme eliminacije je iznosilo 3,2 ± 0,42 h.
English: Pick up the 1 ml small syringe.
Croatian: 2. Uzmite malu štrcaljku od 1 ml.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING IMMEDIATE OUTER CARTON FOR WATER FOR INJECTIONS VIALS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU PRIMARNA KUTIJA ZA BOČICE S VODOM ZA INJEKCIJE
English: • inflamed sinuses
Croatian: • začepljen nos
English: Dose per bid injection (mg/dose)
Croatian: (mg/dozi)
English: Common (affects less than 1 in 10 people)
Croatian: Često (javljaju se u manje od 1 na 10 osoba) • upala pluća
English: dGrade 3= ≥ 25 mm but < 50 mm average diameter; Grade 4= ≥ 50 mm average diameter.
Croatian: d Stupanj 3 = prosječan promjer ≥ 25 mm, ali < 50 mm; Stupanj 4 = prosječan promjer ≥ 50 mm. e Stupanj 3 = ≥ 3 cm; Stupanj 4 = ako je prisutan eksudat.
English: Please contact your doctor if this occurs.
Croatian: Ako se to dogodi, javite se svom liječniku.
English: Sodium hydroxide Hydrochloric Acid
Croatian: Prašak natrijev karbonat manitol natrijev hidroksid kloridna kiselina
English: Powder and solvent for solution for injection
Croatian: Prašak i otapalo za otopinu za injekciju
English: Appetite decreased, anorexia, hypertriglyceridaemia, blood triglycerides increased, diabetes mellitus
Croatian: povišene razine triglicerida u krvi, šećerna bolest
English: bGrade 3= severe pain requiring analgesics (or narcotic analgesics for ≤ 72 hours) and/or limiting usual activities; Grade 4=
Croatian: 4,7%g a Bilo kojeg stupnja težine b Stupanj 3 = jaka bol koja zahtijeva primjenu analgetika (ili narkoanalgetika tijekom ≤ 72 sata) i/ili ograničava uobičajene aktivnosti; Stupanj 4 = jaka bol koja zahtijeva hospitalizaciju ili produljenje hospitalizacije, rezultira smrću ili trajnim odnosno značajnim invaliditetom/onesposobljenošću, ili ugrožava život, ili je medicinski značajna.
English: • feeling weak
Croatian: • osjećaj slabosti
English: - Dispose of packaging and vial caps into your special waste container with a lid. - Place syringes and vials onto a clean surface.
Croatian: Otvorite pakiranja sa štrcaljkama i skinite kapice s bočica - Bacite pakiranja i kapice bočica u poseban spremnik za otpad s poklopcem.
English: SPECIAL STORAGE CONDITIONS Keep the vial in the outer carton in order to protect from light After reconstitution store in a refrigerator
Croatian: POSEBNE MJERE ČUVANJA Bočicu čuvati u vanjskom pakiranju radi zaštite od svjetlosti
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
Croatian: 14. NAČIN IZDAVANJA LIJEKA Lijek se izdaje na recept
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Croatian: Unatoč smanjenom riziku zbog djelotvorne antiretrovirusne terapije, svejedno možete prenijeti HIV tijekom uzimanja ovog lijeka.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FUZEON VIAL LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA BOČICE LIJEKA FUZEON
English: Marketing Authorisation Holder Roche Registration GmbH Emil-Barell-Strasse 1
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Roche Registration GmbH
English: 2Based on GSS score.
Croatian: 2Na temelju rezultata genotipske osjetljivosti
English: NA
Croatian: ND
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.
Croatian: - Bacite bočicu u poseban spremnik za otpad s poklopcem ili je vratite u ljekarnu.
English: 1 ml of reconstituted solution contains 90 mg of enfuvirtide.
Croatian: 1 ml pripremljene otopine sadrži 90 mg enfuvirtida.
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.
Croatian: Učinite to čak i ako u bočicama preostane određena količina neupotrijebljenog lijeka ili vode za injekcije, jer su bočice namijenjene isključivo za jednokratnu uporabu.
English: PHARMACEUTICAL FORM Powder and solvent for solution for injection.
Croatian: Prašak i otapalo za otopinu za injekciju.
English: Dispose of the syringe into a special waste container with a lid. 3.
Croatian: Zbrinite štrcaljku u poseban spremnik za otpad s poklopcem.
English: Injecting Water For Injections Into Fuzeon Powder
Croatian: Ubrizgavanje vode za injekcije u Fuzeon prašak 1.