FrancophonIA/ELRC3.0 huggingface dataset:
English: Safety results are expressed as the number of patients with an adverse reaction per 100 patientyears of exposure (except for injection site reactions).
Croatian: Sigurnosni rezultati su izraženi kao broj bolesnika koji su imali neku nuspojavu na 100 bolesnik-godina izloženosti (osim za reakcije na mjestu injiciranja).
English: The injection should be given at a site different from the preceding injection site and where there is no current injection site reaction.
Croatian: Injekciju treba dati na različito mjesto od prethodnog mjesta injiciranja i tamo gdje trenutno nema reakcije na mjestu injiciranja.
English: However, if it is less than 6 hours before the next regular dose, the missed dose should be skipped
Croatian: Međutim, ako ima manje od 6 sati do iduće redovne doze, propuštena doza se mora preskočiti.
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.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i kasnog embrionalnog razvoja.
English: Fuzeon helps by preventing this.
Croatian: Fuzeon to sprečava i na taj način pomaže.
English: Infections at the injection site (including abscess and cellulitis) occurred in 1.5% of patients.
Croatian: Infekcije na mjestu injiciranja (uključujući apsces i celulitis) javile su se u 1,5% bolesnika.
English: Patients with liver disease
Croatian: Bolesnici s jetrenom bolešću
English: There you will find instructions on how to prepare Fuzeon and how to give yourself an injection.
Croatian: Tamo ćete pronaći upute o tome kako ćete pripremiti Fuzeon i kako ćete si dati injekciju.
English: Fuzeon contains no preservative.
Croatian: Fuzeon ne sadrži konzervanse.
English: The substitutions observed in decreasing frequency were at aa positions 38, 43, 36, 40, 42 and 45.
Croatian: Supstitucije su opažene, prema padajućoj učestalosti, na mjestima 38, 43, 36, 40, 42 i 45 aminokiselina.
English: Children ≥ 6 years and adolescents: The experience in children is limited (see section 5.2).
Croatian: Djeca u dobi od ≥ 6 godina i adolescenti: Iskustvo primjene u djece je ograničeno (vidjeti dio 5.2).
English: If you are preparing both of your daily doses at one time, make sure to use new syringes, Water for Injections, and Fuzeon for each dose.
Croatian: Ako obje svoje dnevne doze pripremate u isto vrijeme, pazite da za svaku dozu koristite nove štrcaljke, novu vodu za injekcije i novu bočicu lijeka Fuzeon.
English: If you use more Fuzeon than you should, talk to a doctor or go to a hospital straight away.
Croatian: Ako primijenite više lijeka Fuzeon nego što ste trebali, obratite se svom liječniku ili odmah otiđite u bolnicu.
English: What Fuzeon is and what it is used for What you need to know before you use Fuzeon How to use Fuzeon
Croatian: Što je Fuzeon i za što se koristi Što morate znati prije nego počnete primjenjivati Fuzeon
English: Injection site reactions (ISRs) were the most frequently reported adverse reaction and occurred in 98% of the patients (Table 3).
Croatian: Reakcije na mjestu injiciranja bile su najčešće prijavljena nuspojava i javile su se u 98% bolesnika (Tablica 3).
English: No case of overdose has been reported.
Croatian: Nisu zabilježeni slučajevi predoziranja.
English: Step C: Preparing for the injection
Croatian: Korak C: Priprema za injekciju
English: Includes discontinuations from loss to follow-up, treatment refusal, and other reasons.
Croatian: Obuhvaća izlazak iz ispitivanja zbog prekida praćenja, odbijanja liječenja i drugih razloga.
English: Excipient with known effect: sodium.
Croatian: Pomoćna tvar s poznatim učinkom: natrij.
English: ● Never use a syringe with a bent or damaged needle.
Croatian: Nikada nemojte koristiti štrcaljke sa savijenom ili oštećenom iglom.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: This injects the air.
Croatian: Tako ćete ubrizgati zrak.
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Croatian: Iako učinkovita viralna supresija s antiretroviralnom terapijom dokazano značajno smanjuje rizik prijenosa spolnim putem, rezidualni rizik ne može se isključiti.
English: This pack provides you with everything you need to prepare and take your Fuzeon for 30 days of injections.
Croatian: Ovo pakiranje sadrži sve što Vam je potrebno za pripremu i primjenu lijeka Fuzeon tijekom 30 dana.
English: • hold the vial between the thumb and forefinger of your right hand.
Croatian: ● držati bočicu između palca i kažiprsta desne ruke.
English: The resistance to influenza and streptococcal infection in rats was only weakly compromised.
Croatian: Otpornost štakora na gripu i streptokoknu infekciju bila je samo malo kompromitirana.
English: • Do not inject to a place where there is still a reaction from an earlier dose.
Croatian: • Ne smijete injicirati lijek na mjesto gdje je još prisutna reakcija od neke prethodne doze.
English: This improvement enables the body to fight infections that may have been present with no obvious symptoms.
Croatian: Tako oporavljen organizam može se boriti protiv infekcija koje su možda bile prisutne bez vidljivih simptoma.
English: If you notice any symptoms of infection, please inform your doctor immediately.
Croatian: Ako primijetite bilo koji simptom infekcije, odmah obavijestite svog liječnika.
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.
Croatian: Ako prestanete primjenjivati lijek i dođe do pauze u liječenju, to može povećati vjerojatnost da će HIV u Vašoj krvi brže postati otporan na Fuzeon.
English: To make sure that the needle is firmly on the syringe:
Croatian: Da biste provjerili je li igla čvrsto pričvršćena na štrcaljku:
English: • feeling anxious or irritated
Croatian: • tjeskoba ili razdražljivost
English: These patients did not experience any adverse reactions that were not seen with the recommended dose.
Croatian: U tih bolesnika nisu nastupile nuspojave koje nisu opažene kod primjene preporučene doze.
English: Signs of autoimmune disorders
Croatian: Znakovi autoimunih poremećaja
English: • hold the plastic cap under the needle protector
Croatian: • uhvatite plastičnu kapicu ispod štitnika igle
English: It is bound predominantly to albumin and to a lower extent to α-1 acid glycoprotein.
Croatian: Pretežno se veže na albumin, a u manjoj mjeri na α-1-kiseli glikoprotein.
English: See further instructions on how to use Fuzeon at the end of this leaflet (see Section 7).
Croatian: Pročitajte daljnje upute o primjeni lijeka Fuzeon na kraju ove Upute o lijeku (vidjeti dio 7.).
English: If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Croatian: Ako primijetite bilo koji simptom infekcije ili druge simptome poput slabosti u mišićima, slabosti koja počinje u šakama i stopalima i širi se prema trupu, lupanja srca, nevoljnog drhtanja ili hiperaktivnosti, odmah obavijestite svog liječnika kako bi ste zatražili potrebno liječenje.
English: After pulling out the needle
Croatian: Nakon vađenja igle
English: There is no specific antidote for overdose with enfuvirtide.
Croatian: Nema specifičnog antidota za predoziranje enfuvirtidom.
English: Animal studies do not indicate harmful effects with respect to foetal development.
Croatian: Istraživanja na životinjama ne ukazuju na štetne učinke vezane za razvoj ploda.
English: Animal studies have shown that enfuvirtide may impair some immune functions (see section 5.3).
Croatian: Istraživanja na životinjama pokazala su da enfuvirtid može štetno djelovati na neke imunološke funkcije (vidjeti dio 5.3).
English: Few patients included in the phase III trials were co-infected with hepatitis B/C.
Croatian: Mali broj bolesnika uključenih u ispitivanja faze III bilo je istodobno zaraženo hepatitisom B/C.
English: Discuss with your physician the precautions needed to avoid infecting other people.
Croatian: Razgovarajte s liječnikom o potrebnim mjerama opreza kako biste izbjegli prijenos na druge osobe.
English: Treatment of overdose should consist of general supportive measures.
Croatian: Liječenje predoziranja treba obuhvaćati opće suportivne mjere.
English: Other PK studies suggest no difference between Asians and Caucasians after adjusting exposure for body weight.
Croatian: Druga farmakokinetička ispitivanja ne ukazuju na postojanje razlika između azijata i bijelaca nakon prilagodbe izloženosti prema tjelesnoj težini.
English: • Be careful not to forcefully shoot water into the powder, since this can cause foaming.
Croatian: • Pazite da ne ubrizgate vodu u prašak presnažno jer to može izazvati pjenjenje.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući one koje ste nabavili bez recepta i biljne lijekove.
English: How to prepare and inject Fuzeon
Croatian: Kako pripremiti i injicirati Fuzeon
English: Autoimmune disorders may occur many months after the start of treatment.
Croatian: Autoimuni poremećaji mogu se javiti i više mjeseci nakon započinjanja liječenja.
English: As with other antiretrovirals, enfuvirtide should optimally be combined with other antiretrovirals to which the patient's virus is sensitive (see section 5.1).
Croatian: Kao i kod drugih antiretrovirusnih lijekova, enfuvirtid je potrebno optimalno kombinirati s drugim antiretrovirusnim lijekovima na koje je virus bolesnika osjetljiv (vidjeti dio 5.1).
English: - This may reduce the time it takes for the powder to dissolve.
Croatian: - Tako će se možda skratiti vrijeme potrebno da se prašak otopi.
English: Malta (See Ireland)
Croatian: (See Ireland)
English: ● Once you have washed your hands, do not touch anything except the medicine and supplies.
Croatian: Nakon što operete ruke, nemojte dodirivati ništa osim lijeka i pribora.
English: The geometric mean changes ranged from 15.2 fold for V38M to 41.6 fold for V38A.
Croatian: Geometrijska sredina promjena bila je u rasponu od 15,2 puta za V38M do 41,6 puta za V38A.
English: How much to use
Croatian: Koliko lijeka primijeniti
English: Subgroups
Croatian: Podskupine
English: Enfuvirtide should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Croatian: Enfuvirtid se smije uzimati tijekom trudnoće samo ako moguća korist od liječenja opravdava mogući rizik za plod.
English: If not, store in a refrigerator and use within 24 hours.
Croatian: U suprotnom se mora čuvati u hladnjaku i upotrijebiti u roku od 24 sata.
English: The frequency of this is unknown (see section 4.4).
Croatian: Učestalost nije poznata (vidjeti dio 4.4).
English: If this happens, your blood levels of virus may begin to rise.
Croatian: U tom slučaju razine virusa u krvi možda će početi rasti.
English: If it is not used straight away it must be stored in a refrigerator (2°C - 8°C) and used within 24 hours.
Croatian: Ako se ne primijeni odmah, mora se čuvati u hladnjaku (2°C - 8°C) i upotrijebiti u roku od 24 sata.
English: This metabolite is detected in human plasma following administration of enfuvirtide, with an AUC ranging from 2.4 to 15% of the enfuvirtide AUC.
Croatian: Ovaj se metabolit nalazi u ljudskoj plazmi nakon primjene enfuvirtida, a njegov se AUC kreće u rasponu od 2,4 do 15% AUC-a enfuvirtida.
English: Please be aware that the vial contains more liquid than you need (2 ml); you only have to pull out 1.1 ml to prepare your injection properly.
Croatian: Uzmite u obzir da se u bočici nalazi više tekućine nego što Vam je potrebno (2 ml); za pravilnu pripremu injekcije trebate izvući samo 1,1 ml.
English: From a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek se mora odmah primijeniti.
English: Fuzeon is not recommended for use in children below age 6 due to insufficient data on safety and efficacy (see section 5.2).
Croatian: Ne preporučuje se primjena Fuzeona u djece mlađe od 6 godina zbog nedostatnih podataka o sigurnosti primjene i djelotvornosti (vidjeti dio 5.2).
English: White to off-white lyophilised powder.
Croatian: Bijeli do bjelkasti liofilizirani prašak.
English: % of Event comprising Grade 4 reactions
Croatian: % događaja s reakcijama stupnja 4
English: Fuzeon is used for the treatment of Human Immune deficiency Virus (HIV) - in combination with other antiretroviral medicines in patients infected with HIV.
Croatian: Fuzeon se koristi za suzbijanje virusa humane imunodeficijencije (HIV) - u kombinaciji s drugim antiretrovirusnim lijekovima u bolesnika zaraženih HIV-om.
English: Most adverse reactions were of mild or moderate intensity.
Croatian: Većina je nuspojava bila blagog ili umjerenog inteziteta.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:
Croatian: DATUM PRVOG ODOBRENJA/ DATUM OBNOVE ODOBRENJA
English: 121 (18.3%) 26 (7.8%) Odds Ratio
Croatian: 121 (18,3%) 26 (7,8%) Omjer vjerojatnosti:
English: Slowly pull back the plunger until the water reaches the 1.1 ml mark.
Croatian: Polagano povlačite klip dok voda ne dođe do oznake za 1,1 ml.
English:  Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Croatian: Znakovi osteonekroze su ukočenost zglobova, tupi bolovi i probadanje u zglobovima (osobito u kuku, koljenu i ramenu) i poteškoće pri kretanju.
English: Check for any places where you may have a reaction by pressing the skin to see if there are any hard bumps.
Croatian: Provjerite je li još prisutna reakcija na nekom mjestu tako da pritisnete kožu da vidite ima li otvrdnule kvržice.
English: Do not use your free hand to press the device over the needle.
Croatian: Nemojte koristiti slobodnu ruku da biste napravu pritisnuli preko igle.
English: - After washing your hands, do not touch anything except the injection supplies and where the injection will be given.
Croatian: Nakon što operete ruke, nemojte dodirivati ništa osim pribora za injiciranje i mjesta na kojem ćete injicirati lijek.
English: Once a dose is mixed with Water for Injections, it must be used straight away.
Croatian: Nakon što se doza lijeka pomiješa s vodom za injekcije, mora se odmah primijeniti.
English: Step E: Disposing of used supplies
Croatian: Korak E: Odlaganje upotrijebljenog pribora
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Croatian: Svaki simptom upale treba procijeniti i po potrebi započeti liječenje.
English: Passing HIV to others
Croatian: Prijenos HIV-a na druge osobe
English: Denominator for non-switch patients: N=112.
Croatian: Zajednički nazivnik za bolesnike koji nisu promijenili terapiju iznosi N=112.
English: Talk to your doctor, pharmacist or nurse before using Fuzeon if:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Fuzeon:
English: However, you still need to follow the instructions given in the package leaflets for the other medicines you are taking.
Croatian: Međutim, i dalje se trebate pridržavati uputa za primjenu drugih lijekova koje uzimate, a koje su navedene u uputama o lijeku.
English: What Fuzeon is and what is it used for
Croatian: Što je Fuzeon i za što se koristi
English: • shaking (tremor)
Croatian: • omaglica • drhtanje (tremor)
English: Although these syringes have this safety feature, it is still important that you dispose of used syringes properly.
Croatian: Iako su štrcaljke opremljene tim sigurnosnim mehanizmom, ipak je važno da upotrijebljene štrcaljke zbrinete na pravilan način.
English: This side effect is rare (affects less than 1 in 1,000 people).
Croatian: Ova je nuspojava rijetka (javlja se u manje od 1 na 1000 osoba).
English: If you notice any of these signs please inform your doctor.
Croatian: Ako primijetite neki od tih znakova, obavijestite svog liječnika.
English: • Fuzeon is not a cure for HIV infection.
Croatian: • Fuzeon neće izliječiti HIV infekciju.
English: In deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different medicinal products.
Croatian: Kod odlučivanja o novom režimu liječenja za bolesnike koji nisu uspješno odgovorili na neki antiretrovirusni režim liječenja, treba pažljivo proučiti prethodno liječenje pojedinog bolesnika i uzorke mutacija povezanih s različitim lijekovima.
English: What Fuzeon looks like and contents of the pack Fuzeon powder and solvent for solution for injection comes in a carton containing:
Croatian: Kako Fuzeon izgleda i sadržaj pakiranja Fuzeon prašak i otapalo za otopinu za injekciju isporučuje se u kutiji koja sadrži:
English: Mechanism of Action: Enfuvirtide is a member of the therapeutic class called fusion inhibitors.
Croatian: Mehanizam djelovanja: Enfuvirtid pripada terapijskoj skupini koja se naziva inhibitorima fuzije.
English: Fuzeon must only be reconstituted with 1.1 ml of Water for Injections.
Croatian: Fuzeon se mora rekonstituirati samo s 1,1 ml vode za injekcije.
English: % of Event comprising Grade 3 reactions
Croatian: % događaja s reakcijama stupnja 3
English: • If foaming happens, it may take longer for the powder to dissolve completely.
Croatian: • Ako se pojavi pjena, možda će trebati više vremena da se prašak potpuno otopi.
English: The Manufacturer responsible for batch release is Roche Pharma AG
Croatian: Proizvođač odgovoran za puštanje serije lijeka u promet je Roche Pharma AG
English: • The active substance is enfuvirtide.
Croatian: • Djelatna tvar je enfuvirtid.
English: The severity of the pain and discomfort did not increase with treatment duration.
Croatian: Intenzitet boli i neugode nije se pojačavao daljnjim liječenjem.
English: • flu or ‘flu-like' symptoms
Croatian: • gripa ili simptomi 'nalik gripi'
English: Antiretroviral drug resistance: Incomplete viral suppression may lead to the development of drug resistance to one or more components of the regimen.
Croatian: Rezistencija na antiretrovirusne lijekove: Nepotpuna supresija virusa može dovesti do razvoja rezistencije na jedan ili više lijekova u režimu liječenja.
English: If there is evidence of particulate matter, the vial must not be used and should be discarded or returned to the pharmacy.
Croatian: Ako se vide čestice, bočica se ne smije upotrijebiti i treba je odbaciti ili vratiti u ljekarnu.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/252/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/252/001
English: Rarely, you may get an infection at a place where an individual injection was given.
Croatian: U rijetkim slučajevima može se razviti infekcija na mjestu gdje je pojedina injekcija primijenjena.
English: fGrade 3= refractory to topical treatment or requiring oral or parenteral treatment; Grade 4= not defined.
Croatian: Stupanj 3 = ne odgovara na topikalno liječenje ili zahtijeva peroralno odnosno parenteralno liječenje; Stupanj 4 = nije definirano.
English: Of these, 185 (98.9%) env genes carried specific substitutions in region of aa 36 - 45 of gp41.
Croatian: Od toga je 185 (98,9%) gena env nosilo specifične supstitucije u području aminokiselina 36-45 glikoproteina 41.
English: Where to Inject
Croatian: Kamo injicirati
English: No clinically significant pharmacokinetic interactions are expected between enfuvirtide and concomitantly given medicinal products metabolised by CYP450 enzymes.
Croatian: Ne očekuju se klinički značajne farmakokinetičke interakcije između enfuvirtida i istodobno primijenjenih lijekova koji se metaboliziraju putem enzima sustava CYP450.
English: Keep this medicine out of the sight and reach of children.
Croatian: Ovaj lijek čuvajte izvan pogleda i dohvata djece.
English: ● Do not use opened materials.
Croatian: Nemojte koristiti pribor koji je bio otvoren.
English: There is no evidence that enfuvirtide may alter the patient's ability to drive and use machines, however, the adverse event profile of enfuvirtide should be taken into account (see section 4.8).
Croatian: Nema dokaza da enfuvirtid može promijeniti bolesnikovu sposobnost upravljanja vozilima i rada sa strojevima, ali treba uzeti u obzir njegov profil nuspojava (vidjeti dio 4.8).
English: The most frequently reported events were injection site reactions, diarrhoea and nausea.
Croatian: Najčešće prijavljene nuspojave bile su reakcije na mjestu injiciranja, proljev i mučnina.
English: Step A: Getting Started
Croatian: Korak A: Početna priprema
English: Injection volume (90 mg enfuvirtide per ml)
Croatian: Volumen injekcije (90 mg enfuvirtida po ml)
English: Gender and Weight: Analysis of plasma concentration data from patients in clinical trials indicated that the clearance of enfuvirtide is 20% lower in females than males irrespective of weight and is increased with increased body weight irrespective of gender (20% higher in a 100 kg and 20% lower in a 40 kg body weight patient relative to a 70 kg reference patient).
Croatian: Spol i tjelesna težina: Analiza podataka o koncentraciji u plazmi u bolesnika u kliničkim ispitivanjima pokazala je da je klirens enfuvirtida 20% manji u žena nego u muškaraca neovisno o tjelesnoj težini, dok se pojačava s povećanjem tjelesne težine neovisno o spolu (20% je veći u bolesnika tjelesne težine 100 kg i 20% manji u bolesnika tjelesne težine 40 kg u odnosu na referentnog bolesnika od 70 kg).
English: In four separate studies (N = 9 to 12) the mean steady state trough plasma concentration ranged from 2.6 to 3.4 µg/ml.
Croatian: U četiri zasebna ispitivanja (N = 9 do 12) prosječne najniže koncentracije u plazmi u stanju dinamičke ravnoteže kretale su se između 2,6 i 3,4 µg/ml.
English: 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).
Croatian: To je bolest kod koje koštano tkivo odumire jer se ne opskrbljuje krvlju (propadanje koštanog tkiva zbog prestanka opskrbe kosti krvlju).
English: The virus needs to make contact with, and get inside these cells in order for the virus to multiply.
Croatian: Virus mora doći u kontakt s tim stanicama i ući u njih kako bi se mogao umnažati.
English: Less than 13% of the dose was removed during haemodialysis.
Croatian: Hemodijalizom je uklonjeno manje od 13% doze.
English: Patients should be informed that Fuzeon is not a cure for HIV-1 infection.
Croatian: Bolesnicima je potrebno reći da Fuzeon neće izliječiti infekciju virusom HIV-1.
English: Patients had prior exposure to a median of 12 antiretrovirals for a median of 7 years.
Croatian: Bolesnici su prethodno liječeni s 12 (medijan) antiretrovirusnih lijekova u trajanju od 7 (medijan) godina.
English: Tell your doctor if you get side effects where the injection is given The most common side effects (affect more than 1 in 10 people), are problems at the place on your body where you have the injection.
Croatian: Obavijestite svog liječnika ako primijetite nuspojave na mjestu primjene injekcije Najčešće nuspojave (javljaju se u više od 1 na 10 osoba) su tegobe na mjestu primjene injekcije.
English: ● When handling the syringe, do not touch the needle.
Croatian: Kada rukujete štrcaljkom, nemojte dodirivati iglu.
English: ● Never inject your medicine with other injectable medicines.
Croatian: Nikada nemojte injicirati ovaj lijek s drugim lijekovima za injiciranje.