FrancophonIA/ELRC3.0 huggingface dataset:
English: angioedema3, 4, pruritus, urticaria4 Musculoskeletal and connective tissue disorders Uncommon:
Croatian: angioedem3, 4, svrbež, urtikarija4
English: • itching (pruritus)
Croatian: • svrbež (pruritus) • koprivnjača (urtikarija)
English: SEDATIVES/HYPNOTICS Orally administered midazolam (2.5 mg single dose), tenofovir alafenamide (25 mg once daily)
Croatian: Peroralno primijenjen midazolam (jednokratna doza od 2,5 mg), tenofoviralafenamid (25 mg jedanput na dan)
English: E/C/F/TDF (n = 867)
Croatian: E/C/F/TDF
English: Lopinavir/ritonavir (800/200 mg once daily), tenofovir alafenamide (10 mg once daily)
Croatian: Lopinavir/ritonavir (800/200 mg jedanput na dan), tenofoviralafenamid (10 mg jedanput na dan)
English: Tenofovir alafenamide is permeable into cells and due to increased plasma stability and intracellular activation through hydrolysis by cathepsin A, tenofovir alafenamide is more efficient than tenofovir disoproxil fumarate in concentrating tenofovir in peripheral blood mononuclear cells (PBMCs) or HIV target cells including lymphocytes and macrophages.
Croatian: A djelotvorniji od tenofovirdizoproksilfumarata u koncentriranju tenofovira u mononuklearnim stanicama periferne krvi (PBMC) ili ciljnim stanicama virusa HIV-a koje uključuju limfocite i makrofage.
English: Tenofovir alafenamide exposure is expected to decrease when tipranavir/ritonavir is used in combination with Descovy.
Croatian: Kad se tipranavir/ritonavir primjenjuje u kombinaciji s lijekom Descovy, očekuje se smanjenje izloženosti tenofoviralafenamidu
English: ANTIDEPRESSANTS Sertraline (50 mg once daily), tenofovir alafenamide (10 mg once daily)3
Croatian: Sertralin (50 mg jedanput na dan), tenofoviralafenamid (10 mg jedanput na dan)3
English: The safety of emtricitabine and tenofovir alafenamide was evaluated through 48 weeks in an openlabel clinical study (GS-US-292-0106) in which HIV-1 infected, treatment-naïve paediatric patients aged 12 to < 18 years received emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet.
Croatian: Sigurnost emtricitabina i tenofoviralafenamida procijenjena je tijekom 48 tjedana otvorenog kliničkog Ispitivanja (GS-US-292-0106) u kojem su pedijatrijski bolesnici u dobi od 12 do < 18 godina zaraženi virusom HIV-1 koji prethodno nisu bili liječeni primali fiksnu kombinaciju emtricitabina i tenofoviralafenamida s elvitegravirom i kobicistatom u jednoj tableti.
English: In Study GS-US-311-1089, the efficacy and safety of switching from emtricitabine/tenofovir disoproxil fumarate to Descovy while maintaining the third antiretroviral agent were evaluated in a randomised, double-blind study of virologically suppressed HIV-1 infected adults (n = 663).
Croatian: U randomiziranom, dvostruko slijepom Ispitivanju GS-US-311-1089 procjenjivane su djelotvornost i sigurnost prebacivanja odraslih bolesnika (n = 663) zaraženih virusom HIV-1 kod kojih je virus bio suprimiran s režima emtricitabin/tenofovirdizoproksilfumarat na lijek Descovy uz zadržavanje liječenja trećim antiretrovirusnim lijekom.
English: Atazanavir with ritonavir or cobicistat Darunavir with ritonavir or cobicistat1 Lopinavir with ritonavir
Croatian: Descovy 200/10 mg jedanput na dan atazanavir s ritonavirom ili kobicistatom darunavir s ritonavirom ili kobicistatom1
English: No dose adjustment of Descovy is required in adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis; however, Descovy should generally be avoided but may be used in these patients if the potential benefits are considered to outweigh the potential risks (see sections 4.4 and 5.2).
Croatian: Međutim, iako Descovy općenito treba izbjegavati u ovih bolesnika, može ga se primijeniti ako se smatra da su moguće koristi veće od mogućih rizika (vidjeti dijelove 4.4 i 5.2).
English: Missing data during window but on study drug Proportion (%) of patients with HIV-1 RNA < 50 copies/mL by prior treatment regimen Boosted PIs Other third agents
Croatian: Udio (%) bolesnika s HIV-1 RNK < 50 kopija/ml prema prethodnom režimu liječenja
English: E/C/F/TDFe (n = 867)
Croatian: E/C/F/TDFe
English: Patients should be informed that dizziness has been reported during treatment with Descovy.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Bolesnike treba obavijestiti da je zabilježena omaglica tijekom liječenja lijekom Descovy.
English: No clinically relevant differences in tenofovir alafenamide, or tenofovir pharmacokinetics were observed between healthy subjects and patients with severe renal impairment (estimated CrCl > 15 mL/min and < 30 mL/min) in a Phase 1 study of tenofovir alafenamide.
Croatian: Nisu zapažene klinički značajne razlike u farmakokinetici tenofoviralafenamida ili tenofovira između zdravih ispitanika i bolesnika s teškim oštećenjem funkcije bubrega (procijenjeni CrCl > 15 ml/min i
English: Darunavir/ritonavir (800/100 mg once daily), tenofovir alafenamide (10 mg once daily)
Croatian: Darunavir/ritonavir (800/100 mg jedanput na dan), tenofoviralafenamid (10 mg jedanput na dan)
English: The safety of emtricitabine and tenofovir alafenamide was evaluated through 48 weeks in a single arm, open-label clinical study (GS-US-292-1825) in which 55 virologically suppressed HIV-1 infected patients with end stage renal disease (eGFRCG < 15 mL/min) on chronic haemodialysis received emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet.
Croatian: Sigurnost emtricitabina i tenofoviralafenamida procijenjena je tijekom 48 tjedana otvorenog kliničkog ispitivanja (GS-US-292-1825) u kojem je jedna skupina od 55 bolesnika zaraženih virusom HIV-1 u kojih je virus bio suprimiran, sa završnim stadijem bolesti bubrega (eGFRCG < 15 ml/min) i na kroničnoj hemodijalizi, primala fiksnu kombinaciju emtricitabina i tenofoviralafenamida s elvitegravirom i kobicistatom u jednoj tableti.
English: HIV-1 RNA < 20 copies/mL Treatment difference
Croatian: HIV-1 RNK < 20 kopija/ml Razlika u liječenju
English: HIV-1 infected patients with mild to moderate renal impairment In Study GS-US-292-0112, the efficacy and safety of emtricitabine and tenofovir alafenamide were evaluated in an open-label clinical study in which 242 HIV-1 infected patients with mild to moderate renal impairment (eGFRCG: 30-69 mL/min) were switched to emtricitabine and tenofovir alafenamide (10 mg) given with elvitegravir and cobicistat as a fixed-dose combination tablet.
Croatian: U otvorenom kliničkom Ispitivanju GS-US-292-0112 procijenjena je djelotvornost i sigurnost emtricitabina i tenofoviralafenamida u 242 bolesnika zaražena virusom HIV-1 s blagim do umjerenim oštećenjem funkcije bubrega (eGFRCG: 30-69 ml/min) koji su bili prebačeni na fiksnu kombinaciju emtricitabina i tenofoviralafenamida (10 mg) s elvitegravirom i kobicistatom u jednoj tableti.
English: Co-administration of oxcarbazepine, phenobarbital, or phenytoin, all of which are P-gp inducers, may decrease tenofovir alafenamide plasma concentrations, which may result in loss of therapeutic effect and development of resistance.
Croatian: Istodobna primjena okskarbazepina, fenobarbitala i fenitoina, koji su svi induktori P-gp-a, može smanjiti koncentracije tenofoviralafenamida u plazmi, što može dovesti do gubitka terapijskog učinka i razvoja rezistencije.
English: The EC50 values for tenofovir alafenamide were in the range of 2.0 to 14.7 nM. Tenofovir alafenamide displayed antiviral activity in cell culture against all HIV-1 groups
Croatian: Vrijednosti EC50 za tenofoviralafenamid bile su u rasponu od 2,0 do 14,7 nM.
English: Tenofovir alafenamide
Croatian: emtricitabin/tenofoviralafenamid
English: E/C/F/TAF (n = 866)
Croatian: (n = 866)
English: There were no new safety issues identified in patients with end stage renal disease on chronic haemodialysis receiving emtricitabine and tenofovir alafenamide, in combination with elvitegravir and cobicistat as a fixed-dose combination tablet (see section 5.2).
Croatian: Nije bilo utvrđenih novih sigurnosnih pitanja u bolesnika sa završnim stadijem bolesti bubrega na kroničnoj hemodijalizi koji su primali fiksnu kombinaciju emtricitabina i tenofoviralafenamida s elvitegravirom i kobicistatom u jednoj tableti
English: Co-administration of St. John's wort, a P-gp inducer, may decrease tenofovir alafenamide plasma concentrations, which may result in loss of therapeutic effect and development of resistance.
Croatian: Istodobna primjena gospine trave, induktora P-gp-a, može smanjiti koncentracije tenofoviralafenamida u plazmi, što može dovesti do gubitka terapijskog učinka i razvoja rezistencije.
English: Co-administration of carbamazepine, a P-gp inducer, decreases tenofovir alafenamide plasma concentrations, which may result in loss of therapeutic effect and development of resistance.
Croatian: induktora P-gp-a, smanjuje koncentracije tenofoviralafenamida u plazmi, što može dovesti do gubitka terapijskog učinka i razvoja rezistencije.
English: AUC: ↑ 75%
Croatian: Cmin: ↑ 58%
English: Anti-hepatitis C virus medicinal products Ledipasvir (90 mg once daily)/ sofosbuvir (400 mg once daily), emtricitabine (200 mg once daily)/ tenofovir alafenamide (10 mg once daily)3
Croatian: Lijekovi protiv virusa hepatitsa C Ledipasvir (90 mg jedanput na dan)/ sofosbuvir (400 mg jedanput na dan), emtricitabin (200 mg jedanput na dan)/
English: Iron oxide black (E172)
Croatian: titanijev dioksid makrogol 3350 talk željezov oksid, crni (E172)
English: Cmax: ↓ 21%
Croatian: AUC: ↔ Cmax: ↓ 21%
English: Co-administration of Descovy with St. John's wort is not recommended.
Croatian: Ne preporučuje se istodobna primjena lijeka Descovy s gospinom travom.
English: nausea
Croatian: Nuspojava
English: Cmax, Cmin2
Croatian: Srednja vrijednost postotka promjene AUC, Cmax, Cmin2
English: 3 had missing data.
Croatian: Podaci iz okvira ispitivanja nedostaju,
English: Rifampicin Rifapentine
Croatian: Rifapentin
English: In Study GS-US-292-0106, the efficacy, safety, and pharmacokinetics of emtricitabine and tenofovir alafenamide were evaluated in an open-label study in which 50 HIV-1 infected, treatment-naïve adolescents received emtricitabine and tenofovir alafenamide (10 mg) given with elvitegravir and cobicistat as a fixed-dose combination tablet.
Croatian: U otvorenom Ispitivanju GS-US-292-0106 u kojem je 50 adolescenata zaraženih virusom HIV-1 koji prethodno nisu bili liječeni primalo fiksnu kombinaciju emtricitabina i tenofoviralafenamida (10 mg) s elvitegravirom i kobicistatom u jednoj tableti procijenjene su djelotvornost, sigurnost i farmakokinetika emtricitabina i tenofoviralafenamida.
English: No virologic data at Week 48 or 96 window Discontinued study drug due to AE or deathd
Croatian: HIV-1 RNK ≥ 50 kopija/mlc Bez viroloških podataka u okviru 48. ili 96. tjedna
English: Each film-coated tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
Croatian: Jedna filmom obložena tableta sadržava 200 mg emtricitabina i tenofoviralafenamidfumarat što odgovara 25 mg tenofoviralafenamida.
English: Contents of the pack and other information What Descovy contains
Croatian: Što Descovy sadrži
English: Sofosbuvir/velpatasvir/ voxilaprevir (400 mg/100 mg/100 mg+100 mg once daily)7/ emtricitabine (200 mg once daily)/ tenofovir alafenamide (10 mg once daily)3
Croatian: voksilaprevir (400 mg/100 mg/100 mg+100 mg jedanput na dan)7/
English: Each Descovy film-coated tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide.
Croatian: Jedna filmom obložena tableta lijeka Descovy sadrži 200 mg emtricitabina i tenofoviralafenamidfumarata što odgovara 10 mg tenofoviralafenamida.
English: Each film-coated tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide.
Croatian: Jedna filmom obložena tableta sadržava 200 mg emtricitabina i tenofoviralafenamidfumarat što odgovara 10 mg tenofoviralafenamida.
English: Ledipasvir (90 mg once daily)/ sofosbuvir (400 mg once daily), emtricitabine (200 mg once daily)/ tenofovir alafenamide (25 mg once daily)4
Croatian: Ledipasvir (90 mg jedanput na dan)/ sofosbuvir (400 mg jedanput na dan), emtricitabin (200 mg jedanput na dan)/
English: Tenofovir alafenamide: AUC: ↓ 14% Cmax: ↓ 22%
Croatian: AUC: ↓ 14% Cmax: ↓ 22%
English: Each Descovy film-coated tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
Croatian: Jedna filmom obložena tableta lijeka Descovy sadržava 200 mg emtricitabina i tenofoviralafenamidfumarata što odgovara 25 mg tenofoviralafenamida.
English: cholesterol and glucose, or in the fasting total cholesterol to HDL cholesterol ratio in either treatment arm at Week 96.
Croatian: U 96. tjednu gotovo nije bilo promjene od početne vrijednosti u medijanu vrijednosti HDL kolesterola i glukoze natašte ili omjeru ukupnog kolesterola i HDL kolesterola natašte ni u jednoj skupini.
English: Carbamazepine (titrated from 100 mg to 300 mg twice a day), emtricitabine/tenofovir alafenamide (200 mg/25 mg once daily) 5,6
Croatian: emtricitabin (200 mg jedanput na dan)/tenofoviralafenamid (25 mg jedanput na dan)4
English: Breast-feeding
Croatian: Rifampicin
English: Baseline CD4+ cell count < 200 cells/mm3
Croatian: Početni broj CD4+ stanica
English: Carbamazepine (titrated from 100 mg to 300 mg twice a day), emtricitabine/tenofovir alafenamide (200 mg/25 mg once daily)5,6
Croatian: Karbamazepin (titriran od 100 mg do 300 mg dvaput na dan), emtricitabin/tenofoviralafenamid
English: Protection lasts for one year.
Croatian: Zaštita traje jednu godinu.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 15 March 2016.
Croatian: Budući da je tvrtka dostavila dodatne zatražene informacije, „iznimne okolnosti” su prestale 15. ožujka 2016.
English: This document is a summary of the European Public Assessment Report.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Croatian: Ako želite više informacija na temelju kojih je CVMP donio svoje preporuke, pročitajte znanstvenu raspravu (također dio EPAR-a).
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to stimulate a better reaction by the immune system.
Croatian: Cjepivo također sadržava „adjuvanse” (aluminijev hidroksid i saponin) kako bi se potaknula bolja reakcija imunosnog sustava.
English: If you need more information about your animal's medical condition or treatment, contact your veterinarian.
Croatian: Ako trebate više informacije o zdravstvenom stanju ili liječenje svoje životinje, obratite se svojem veterinaru.
English: The most common side effect with Bluevac BTV8 (which may affect up to 1 in 10 animals) is an increase in body temperature between 0.5 and 1.0˚C that lasts no longer than one to two days.
Croatian: Najčešća nuspojava VMP-a Bluevac BTV8 (koja se može javiti u 1 od 10 životinja) jest porast tjelesne temperature od 0,5 do 1,0˚C u trajanju ne dužem od jednog do dva dana.
English: Protection starts 31 days after the second injection in cattle and 20 days after the second injection in sheep.
Croatian: Zaštita počinje 31 dan nakon primjene druge injekcije u goveda i 20 dana nakon primjene druge injekcije u ovaca.
English: The vaccine is available as a suspension for injection and can only be obtained with a prescription.
Croatian: Cjepivo je dostupno kao suspenzija za injekciju i izdaje se samo na recept.
English: The first injection is given from two and a half months of age and a second injection is given three weeks later.
Croatian: Prva se injekcija daje u dobi od najmanje dva i pol mjeseca, a druga tri tjedna kasnije.
English: The effectiveness of the vaccine was investigated in a number of laboratory trials in sheep and cattle of the minimum recommended age.
Croatian: Djelotvornost cjepiva ispitana je u nizu laboratorijskih ispitivanja na ovcama i govedima preporučene minimalne starosti.
English: In the future, if the animals are exposed to the same type of bluetongue virus, the immune system will be able to produce antibodies more quickly.
Croatian: Ako životinje ubuduće budu izložene istom serotipu virusa bolesti plavog jezika, imunosni sustav brže će moći proizvesti protutijela.
English: The full EPAR for Bluevac BTV8 can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP Bluevac BTV8 nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: In all studies the vaccinated sheep and cattle were compared with unvaccinated animals (controls).
Croatian: U svim ispitivanjima cijepljene ovce i goveda uspoređeni su s necijepljenim životinjama (kontrolna skupina).
English: The vaccine is given to cattle and sheep as two injections under the skin.
Croatian: Cjepivo se daje govedima i ovcama ubrizgavanjem dviju injekcija pod kožu.
English: When it is given to cattle and sheep, the animals' immune system recognises the virus as ‘foreign' and produces antibodies against it.
Croatian: Kada se cjepivo daje govedima i ovcama, imunosni sustav životinje prepoznaje virus kao „strano tijelo” i proizvodi protutijela protiv njega.
English: Bluevac BTV8 was originally authorised under ‘exceptional circumstances' because, as bluetongue disease falls under national disease control programmes, limited information was available at the time of approval.
Croatian: Bluevac BTV8 je prvobitno odobren u „iznimnim okolnostima” jer bolest plavog jezika pripada nacionalnom programu za upravljanje bolesti te su u trenutku izdavanja odobrenja bile dostupne samo ograničene informacije.
English: The withdrawal period for meat and milk from cattle and sheep treated with Bluevac BTV8 is ‘zero' days, which means that there is no mandatory waiting time.
Croatian: Razdoblje karencije za meso i mlijeko goveda i ovaca liječenih VMP-om Bluevac BTV8 iznosi „nula” dana, drugim riječima, nema obveznog perioda čekanja.
English: For booster vaccination a single injection is given every year.
Croatian: Docjepljivanje se vrši jednom injekcijom svake godine.
English: The European Commission granted a marketing authorisation valid throughout the EU, for Bluevac BTV8 on 14 April 2011.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Bluevac BTV8 na snazi u Europskoj uniji od 14. travnja 2011.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Bluevac BTV8's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji odlučio je da koristi od VMP-a Bluevac BTV8 nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: The main measures of the effectiveness of the vaccine were viraemia (levels of BTV8 in the blood) and clinical signs of bluetongue virus infection.
Croatian: Glavna mjerila djelotvornosti cjepiva bila su viremija (razine BTV8 u krvi) i klinički znakovi infekcije virusom bolesti plavog jezika.
English: For more information about treatment with Bluevac BTV8, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMP-om Bluevac BTV8 vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: Bluevac BTV8 contains a bluetongue virus that has been inactivated so that it cannot cause the disease.
Croatian: Bluevac BTV8 sadržava virus bolesti plavog jezika koji je inaktiviran kako ne bi mogao uzrokovati bolest.
English: Bluevac BTV8 contains bluetongue viruses of one type (‘serotype 8').
Croatian: Bluevac BTV8 sadržava viruse bolesti plavog jezika jednog serotipa („serotip 8”).
English: For the full list of restrictions and all side effects reported with Bluevac BTV8, see the package leaflet.
Croatian: Potpuni popis ograničenja i svih nuspojava zabilježenih pri primjeni VMP-a Bluevac BTV8 potražite u uputi o VMP-u.
English: Bluevac BTV8 is a vaccine used in cattle and sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus, which is transmitted by midges.
Croatian: Bluevac BTV8 je cjepivo koje se primjenjuje u goveda i ovaca radi zaštite od bolesti plavog jezika, infekcije koju uzrokuje virus bolesti plavog jezika koji prenose mušice.
English: The vaccine is used to prevent viraemia (the presence of viruses in the blood) and to reduce clinical signs caused by bluetongue virus in sheep and to prevent viraemia in cattle.
Croatian: Cjepivo se primjenjuje radi sprečavanja viremije (prisutnosti virusa u krvi) i ublaživanja kliničkih znakova uzrokovanih virusom bolesti plavog jezika u ovaca te sprečavanja viremije u goveda.
English: Clinical signs of the disease include fever, skin ulceration, as well as swelling and occasionally blueish discolouration of the tongue mainly seen in sheep.
Croatian: Klinički znakovi bolesti uključuju vrućicu, kožni ulkus i otekline te povremenu promjenu boje jezika u plavkastu koja se uglavnom javlja u ovaca.
English: The studies showed that the vaccine prevents viraemia in sheep and cattle and reduces clinical signs in sheep when infected with bluetongue virus serotype 8.
Croatian: Ispitivanja su pokazala da se cjepivom sprečava viremija u ovaca i goveda te ublažavaju klinički znakovi u ovaca zaraženih virusom bolesti plavog jezika serotipa 8.
English: bluetongue virus vaccine serotype 8 (inactivated)
Croatian: cjepivo s virusom plavog jezika, serotip 8 (inaktiviran)
English: What is Bluevac BTV8 and what is it used for?
Croatian: Što je Bluevac BTV8 i za što se koristi?
English: Bluevac BTV8 is a vaccine.
Croatian: Bluevac BTV8 je cjepivo.
English: The vaccine contains inactivated (killed) bluetongue virus serotype 8.
Croatian: Cjepivo sadržava inaktivirani (umrtvljeni) virus bolesti plavog jezika, serotip 8.
English: What are the risks associated with Bluevac BTV8?
Croatian: Koji su rizici povezani s VMP-om Bluevac BTV8?
English: Why is Bluevac BTV8 approved?
Croatian: Zašto je Bluevac BTV8 odobren?
English: Other information about Bluevac BTV8:
Croatian: Ostale informacije o VMP-u Bluevac BTV8
English: How is Bluevac BTV8 used?
Croatian: Kako se Bluevac BTV8 koristi?
English: How does Bluevac BTV8 work?
Croatian: Kako djeluje Bluevac BTV8?
English: What benefits have Bluevac BTV8 shown in studies?
Croatian: Koje su koristi VMP-a Bluevac BTV8 utvrđene u ispitivanjima?
English: 0.5 ml (40000 IU/ml) 6 (6 x 1) pre-filled syringes (multipack)
Croatian: 0,5 ml (40 000 IU/ml) 6 (6 x 1) napunjenih štrcaljki (višestruko pakiranje)
English: 1.0 ml (40000 IU/ml) 4 (4 x 1) pre-filled syringes (multipack)
Croatian: 1,0 ml (40 000 IU/ml) 4 (4 x 1) napunjene štrcaljke (višestruko pakiranje))
English: 4 (4 x 1) pre-filled syringes (multipack)
Croatian: 4 (4 x 1) napunjene štrcaljke (višestruko pakiranje))
English: 1 pre-filled syringe
Croatian: napunjena štrcaljka napunjene štrcaljke napunjenih štrcaljki
English: EU/1/18/1334/001
Croatian: EU/1/18/1334/001 Vaborem 1 g / 1 g Prašak za koncentrat za otopinu za infuziju
English: Intravenous use vial (glass)
Croatian: Za primjenu u venu staklenoj bocici
English: What is Izba and what is it used for?
Croatian: Što je Izba i za što se koristi?
English: The full EPAR for Izba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Izba nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This can result in serious vision loss and even blindness.
Croatian: To može rezultirati ozbiljnim gubitkom vida ili čak sljepoćom.
English: What measures are being taken to ensure the safe and effective use of Izba?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Izba?