natgillin/translations-raw huggingface dataset:
Concentrations of atorvastatin are increased when co-administered with elvitegravir and cobicistat.
Koncentracije atorvastatina povećane su kada se primjenjuje s elvitegravirom i kobicistatom.
Three patients with emergent HIV-1 resistance to Genvoya were identified (M184M/I; M184I+E92G; M184V+E92Q) up to Week 96 in a clinical study of virologically suppressed patients who switched from a regimen containing emtricitabine/tenofovir disoproxil and a third agent (GS-US-292-0109, n = 959).
U kliničkom ispitivanju u bolesnika kod kojih je virus suprimiran te koji su prešli s režima koji sadrži emtricitabin/tenofovirdizoproksil i treći lijek (GS-US-292-0109, n = 959), do 96. tjedna identificirana su tri bolesnika s novonastalom rezistencijom HIV-1 (M184M/I; M184I+E92G; M184V+E92Q) na lijek Genvoya.
Concentrations of telithromycin and/or cobicistat may be altered with co-administration of Genvoya.
Koncentracije telitromicina i/ili kobicistata mogu se izmijeniti s istodobnom primjenom lijeka Genvoya.
Missing data during window but on study drug Proportion (%) of patients with HIV-1 RNA < 50 copies/mL by subgroup
Udio (%) bolesnika s HIV-1 RNK < 50 kopija/ml po podskupinama Dob
Concurrent administration of salmeterol and Genvoya is not recommended.
Ne preporučuje se istodobna primjena salmeterola i lijeka
Concentrations of rosuvastatin are transiently increased when administered with elvitegravir and cobicistat.
Koncentracije rosuvastatina kratkotrajno su povećane kada se primjenjuje s elvitegravirom i kobicistatom.
Buprenorphine: AUC: ↑ 35% Cmin: ↑ 66% Cmax: ↑ 12%
AUC: ↑ 35% Cmin: ↑ 66% Cmax: ↑ 12%
Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking Genvoya.
U bolesnika koji uzimaju lijek Genvoya preporučuju se poman nadzor i prilagodba doze metformina.
 Tell your doctor if you are taking these or any other medicines.
kolhicin  Obavijestite svog liječnika ako uzimate navedene ili bilo koje druge lijekove.
AUC: ↓ 21% Cmin: ↓ 67% Cmax: ↔
Elvitegravir: AUC: ↓ 21% Cmin: ↓ 67% Cmax: ↔
Elvitegravir: AUC: ↑ 48% Cmin: ↑ 67%
Elvitegravir: AUC: ↑ 48% Cmin: ↑ 67% Cmax: ↔
In Study GS-US-292-0106, the efficacy, safety, and pharmacokinetics of Genvoya were evaluated in an open-label study in HIV-1 infected, treatment-naïve adolescents between the ages of 12 to < 18 years, weighing ≥ 35 kg (n = 50) in Cohort 1, and in virologically suppressed children between the ages of 8 to < 12 years, weighing > 25 kg (n = 23) in Cohort 2.
U otvorenom ispitivanju GS-US-292-0106 u adolescenata u dobi od 12 do < 18 godina s tjelesnom težinom ≥ 35 kg (n = 50) zaraženih virusom HIV-1 koji prethodno nisu bili liječeni u kohorti 1 i u djece u dobi od 8 do < 12 godina s tjelesnom težinom > 25 kg (n = 23) s virološkom supresijom u kohorti 2 procijenjene su djelotvornost, sigurnost i farmakokinetika lijeka Genvoya.
NARCOTIC ANALGESICS Methadone (80-120 mg)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)
Metadon (80-120 mg)/elvitegravir (150 mg jedanput na dan)/kobicistat (150 mg jedanput na dan)
Co-administration with dabigatran etexilate, a P-glycoprotein (P-gp) substrate, is contraindicated (see section 4.5).
Istodobna primjena s dabigatraneteksilatom, supstratom P-glikoproteina (P-gp) je kontraindicirana
TAFb TFVb EVGe COBIe FTCe TAFf
EVGe COBIe FTCe
Tenofovir alafenamide
Tenofoviralafenamid
Each Genvoya film-coated tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide.
Jedna filmom obložena tableta lijeka Genvoya sadrži 150 mg elvitegravira, 150 mg kobicistata, 200 mg emtricitabina i tenofoviralafenamidfumarata što odgovara 10 mg tenofoviralafenamida.
ORAL CONTRACEPTIVES Drospirenone/Ethinyloestradiol (3 mg/0.02 mg single dose)/ Cobicistat (150 mg once daily)
Drospirenon/etinilestradiol (jedna doza od 3 mg/0,02 mg)/ kobicistat
No dose adjustment of ledipasvir/sofosbuvir and Genvoya is warranted upon co-administration.
Nije potrebna prilagodba doze kod istodobne primjene ledipasvira/sofosbuvira i lijeka Genvoya.
The mean change from baseline in CD4+ cell count at Week 48 was -2 cells/mm3.
Srednja vrijednost promjene od početne vrijednosti u broju stanica CD4+ u 48. tjednu bila je 2 stanice/ mm3.
Seventy-nine percent were male, 63% were White, 18% were
Sedamdeset i devet posto su bili muškarci, 63% su bili bijelci, 18% crnci i 14% azijati.
Each film-coated tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide.
Jedna filmom obložena tableta sadržava 150 mg elvitegravira, 150 mg kobicistata, 200 mg emtricitabina i tenofoviralafenamidfumarata što odgovara 10 mg tenofoviralafenamida.
Telithromycin
Telitromicin
Anti-hepatitis C virus medicinal products Ledipasvir (90 mg once daily)/ Sofosbuvir (400 mg once daily)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)/ Emtricitabine (200 mg once daily)/ Tenofovir alafenamide (10 mg once daily)5
Lijekovi protiv virusa hepatitisa C Ledipasvir (90 mg jedanput na dan)/sofosbuvir (400 mg jedanput na dan)/elvitegravir (150 mg jedanput na dan)/kobicistat (150 mg jedanput na dan)/emtricitabin (200 mg jedanput na dan)/ tenofoviralafenamid (10 mg jedanput na dan)5
In vitro studies have shown that tenofovir alafenamide is metabolised to tenofovir (major metabolite) by cathepsin A in PBMCs (including lymphocytes and other HIV target cells) and macrophages; and by carboxylesterase-1 in hepatocytes.
A u PBMC-ovima (uključujuću limfocite i druge ciljne stanice HIV-a) i makrofazima te pomoću karboksilesteraze-1 u hepatocitima.
Antimycobacterials Rifabutin (150 mg every other day)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)
Rifabutin (150 mg svaki drugi dan)/ elvitegravir (150 mg jedanput na dan)/kobicistat (150 mg jedanput na dan)
Co-administration with Genvoya may result in increased plasma concentrations of this medicinal product, which is associated with the potential for serious or life-threatening adverse reactions.
Istodobna primjena lijeka Genvoya može za posljedicu imati povećane koncentracije ovog lijeka u plazmi, što je povezano s potencijalno ozbiljnim ili životno opasnim nuspojavama.
Caution should be exercised, including consideration of dose reduction, when co-administering Genvoya with tadalafil for the treatment of pulmonary arterial hypertension.
Istodobnu primjenu lijeka Genvoya i tadalafila za liječenje plućne arterijske hipertenzije treba provoditi s oprezom, uključujući i razmatranje snižavanja doze.
AUC: ↓ 25% Cmin: ↓ 44% Cmax: ↔
Etinilestradiol: AUC: ↓ 25% Cmin: ↓ 44% Cmax: ↔
Therapeutic monitoring is recommended upon co-administration with Genvoya.
Terapijski nadzor se preporučuje prilikom istodobne primjene s lijekom Genvoya.
HIV-1 RNA < 20 copies/mL Treatment difference
HIV-1 RNK < 20 kopija/ml
HIV-1 infected patients with mild to moderate renal impairment In Study GS-US-292-0112, the efficacy and safety of Genvoya were evaluated in an open-label clinical study of 242 HIV-1 infected patients with mild to moderate renal impairment (eGFRCG: 30-69 mL/min).
U otvorenom kliničkom ispitivanju GS-US-292-0112 na 242 bolesnika zaražena virusom HIV-1 s blagim do umjerenim oštećenjem funkcije bubrega (eGFRCG: 30-69 ml/min) procijenjena je djelotvornost i sigurnost lijeka Genvoya.
Co-administration of Genvoya and orally administered midazolam is contraindicated (see section 4.3).
Istodobna primjena lijeka Genvoya i midazolama primijenjenog peroralno je kontraindicirana (vidjeti dio 4.3).
ANTICONVULSANTS Carbamazepine (200 mg twice daily)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)
Karbamazepin (200 mg dvaput na dan)/elvitegravir (150 mg jedanput na dan)/kobicistat (150 mg jedanput na dan)
(may affect more than 1 in 10 people) • feeling sick (nausea)
(mogu se javiti u više od 1 na 10 osoba)
4.1% (95% CI: 1.6% to 6.7%, p < 0.001c)
4,1% (95% CI: 1,6% do 6,7%,
Discontinued study drug due to other reasons and last available HIV-1 RNA < 50 copies/mLf
Prekid primanja ispitivanog lijeka zbog nuspojava ili smrtie Prekid primanja ispitivanog lijeka iz drugih razloga i posljednje dostupne vrijednosti HIV-1 RNK
 If any of the side effects get serious tell your doctor.
Ako se neka od ovih nuspojava pogorša, obavijestite svog liječnika.
Sofosbuvir (400 mg once daily)/ Velpatasvir (100 mg once daily)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)/ Emtricitabine (200 mg once daily)/ Tenofovir alafenamide (10 mg once daily)5
Sofosbuvir (400 mg jedanput na dan)/velpatasvir (100 mg jedanput na dan)/elvitegravir (150 mg jedanput na dan)/kobicistat (150 mg jedanput na dan)/emtricitabin (200 mg jedanput na dan)/ tenofoviralafenamid (10 mg jedanput na dan)5
Sofosbuvir:
Sofosbuvir/velpatasvir/
In a pooled analysis, genotyping was performed on plasma HIV-1 isolates from antiretroviral-naïve patients receiving Genvoya in Phase 3 studies GS-US-292-0104 and GS-US-292-0111 with HIV-1 RNA ≥ 400 copies/mL at confirmed virologic failure, Week 144, or time of early study drug discontinuation.
GS-US-292-0111, s HIV-1 RNK ≥ 400 kopija/ml pri potvrđenom virološkom neuspjehu, u 144. tjednu ili u vrijeme ranog prekida primanja ispitivanog lijeka te je provedena analiza objedinjenih podataka.
No dose adjustment of sofosbuvir/velpatasvir/voxilaprevir and Genvoya is warranted upon co-administration.
Nije potrebna prilagodba doze kod istodobne primjene sofosbuvira/velpatasvira/voksilapr evira i lijeka Genvoya.
Tacrolimus
salmeterol
No dose adjustment of sofosbuvir/velpatasvir and Genvoya is warranted upon co-administration.
Nije potrebna prilagodba doze kod istodobne primjene sofosbuvira/velpatasvira i lijeka Genvoya.
Clinical monitoring of therapeutic effects and adverse reactions is recommended when these medicinal products are concomitantly administered with Genvoya.
U slučaju primjene lijeka Genvoya i ovih lijekova u isto vrijeme preporučuje se klinički nadzor terapijskih učinaka i nuspojava.
In Study GS-US-292-1515, the efficacy and safety of Genvoya were evaluated in an open-label study in HIV-1 infected, virologically suppressed adolescents between the ages of 12 and 18 years, weighing ≥ 35 kg (n = 50).
U otvorenom ispitivanju GS-US-292-1515 u adolescenata u dobi od 12 do 18 godina s tjelesnom težinom ≥ 35 kg (n = 50) zaraženih virusom HIV-1 koji su imali virološku supresiju procijenjene su djelotvornost i sigurnost lijeka Genvoya.
• medicines used to treat pulmonary arterial hypertension:
• lijekove koji se primjenjuju za liječenje plućne arterijske hipertenzije: bosentan i tadalafil
Clinical monitoring should be made upon co-administration with Genvoya.
Klinički nadzor mora se primijeniti kod istodobne primjene lijeka Genvoya.
Tenofovir alafenamide:
Tenofoviralafenamid:
Missing data during window but on study drug Proportion (%) of patients with HIV-1 RNA < 50 copies/mL by prior treatment regimen EFV/FTC/tenofovir disoproxil
Udio (%) bolesnika s HIV-1 RNK < 50 kopija/ml na prvotnom režimu liječenja
AUC: ↔ Cmin: ↑ 46% Cmax: ↔
Velpatasvir: AUC: ↔ Cmin: ↑ 46% Cmax: ↔
At Week 144, 83.1% (197/237 patients) maintained HIV-1 RNA < 50 copies/mL after switching to Genvoya.
Nakon prebacivanja na lijek Genvoya, 83,1% (197/237 bolesnika) bolesnika je u 144. tjednu zadržalo HIV-1 RNK < 50 kopija/ml.
AUC: ↑ 43% Cmin: ↑ 51% Cmax: ↑ 40%
Karbamazepin: AUC: ↑ 43% Cmin: ↑ 51% Cmax: ↑ 40%
Amlodipine Diltiazem Felodipine Nicardipine Nifedipine Verapamil
Felodipin Nikardipin Nifedipin
At baseline, median CD4+ cell count was 742 cells/mm3 (range: 255 to 1,246) and median CD4+% was 34% (range: 21 to 53%).
255 - 1246) a medijan CD4+% bio je 34% (raspon: 21 - 53%).
Cmax: ↑ 41%
AUC: ↔ Cmax: ↑ 41%
You must remain under the care of your doctor while taking Genvoya.
Za vrijeme uzimanja lijeka Genvoya morate ostati pod nadzorom svog liječnika.
The antiviral activity of elvitegravir against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid cells, monocyte/macrophage cells, and peripheral blood lymphocytes and the 50% effective concentration (EC50) values were in the range of 0.02 to 1.7 nM. Elvitegravir displayed antiviral activity in cell culture against HIV-1 clades A, B, C, D, E, F, G, and O (EC50 values ranged from 0.1 to 1.3 nM) and activity against HIV-2 (EC50 of 0.53 nM).
Antivirusno djelovanje elvitegravira na laboratorijske i kliničke izolate virusa HIV-1 procijenjeno je na limfoblastoidnim stanicama, monocitnim/makrofagnim stanicama i limfocitima periferne krvi, te su vrijednosti 50%-tne učinkovite koncentracije (EC50) bile u rasponu od 0,02 do 1,7 nM.
Sirolimus
Sirolimus Takrolimus
Emtricitabine:
Buprenorfin:
Atorvastatin (10 mg single dose)/Elvitegravir (150 mg once daily)/Cobicistat (150 mg once daily)/Emtricitabine (200 mg once daily)/Tenofovir alafenamide (10 mg once daily)
Atorvastatin (jedna doza od 10 mg)/elvitegravir (150 mg jedanput na dan)/kobicistat (150 mg jedanput na dan)/emtricitabin (200 mg jedanput na dan)/tenofoviralafenamid (10 mg jedanput na dan)
Apixaban Rivaroxaban Edoxaban
• mučnina Česte nuspojave
Package leaflet: Information for the user Genvoya 150 mg/150 mg/200 mg/10 mg film-coated tablets
Uputa o lijeku: Informacije za bolesnika Genvoya 150 mg/150 mg/200 mg/10 mg filmom obložene tablete elvitegravir/kobicistat/emtricitabin/tenofoviralafenamid
Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)/ Emtricitabine (200 mg once daily)/ Tenofovir alafenamide (10 mg once daily)5
elvitegravir (150 mg jedanput na dan)/kobicistat (150 mg jedanput na dan)/emtricitabin (200 mg jedanput na dan)/tenofoviralafenamid (10 mg jedanput na dan)5
Nephrotoxicity
Carrigtohill
Naloxone:
Drospirenon:
No dose adjustment of Genvoya is required in adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis; however, Genvoya 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).
Međutim, iako lijek Genvoya 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).
No virologic data at Week 48 or 144 window Discontinued study drug due to AE or deathd
HIV-1 RNK ≥ 50 kopija/mlc Bez viroloških podataka u okviru 48. ili 144. tjedna
Caution is warranted and clinical monitoring is recommended upon co-administration with Genvoya.
U slučaju istodobne primjene lijeka Genvoya preporučuju se mjere opreza i klinički nadzor.
It is recommended that the international normalised ratio (INR) be monitored upon co-administration of Genvoya.
U slučaju istodobne primjene lijeka Genvoya preporučuje se praćenje međunarodnog normaliziranog omjera (INR,
ANTIDEPRESSANTS Sertraline (50 mg single dose)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)/ Emtricitabine (200 mg once daily)/ Tenofovir alafenamide (10 mg once daily)5
Sertralin (jedna doza od 50 mg)/ elvitegravir (150 mg jedanput na dan)/kobicistat (150 mg jedanput na dan)/emtricitabin (200 mg jedanput na dan)/tenofoviralafenamid (10 mg jedanput na dan)5
HMG CO-A REDUCTASE INHIBITORS Rosuvastatin (10 mg single dose)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)
Rosuvastatin (jedna doza od 10 mg)/elvitegravir (150 mg jedanput na dan)/kobicistat (150 mg jedanput na dan)
No dose adjustment is required upon co-administration.
Nije potrebna prilagodba doze pri istodobnoj primjeni.
Macrolide antibiotics Clarithromycin
Makrolidni antibiotici
Cobicistat
Dabigatran
Concentrations of warfarin may be affected upon co-administration with Genvoya.
Istodobna primjena s lijekom Genvoya može utjecati na koncentracije varfarina.
Buprenorphine/Naloxone (16/4 to 24/6 mg)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)
24/6 mg)/elvitegravir (150 mg jedanput na dan)/kobicistat (150 mg jedanput na dan)
• stomach pain
• osip • umor
In treatment-naïve patients, a mean change from baseline of 0.04 ± 0.12 mg/dL (3.5 ± 10.6 µmol/L) was observed after 144 weeks of treatment.
U bolesnika koji prethodno nisu bili liječeni uočena je srednja vrijednost promjene od 0,04 ± 0,12 mg/dl
Contents of the pack and other information What Genvoya contains
Drugi lijekovi i Genvoya
Gilead Sciences Netherlands B.V. Tel: + 31 (0) 20 718 36 98
Gilead Sciences, S.L. Tel: + 34 91 378 98 30
ANTI-GOUT Colchicine
LIJEKOVI PROTIV GIHTA
• tenofovir disoproxil
EFV/FTC/tenofovirdizoprok sil
Rosuvastatin: AUC: ↑ 38% Cmin: N/A Cmax: ↑ 89%
Rosuvastatin: AUC: ↑ 38%
Interaction not studied with Genvoya.
Interakcija nije ispitana s lijekom
Gilead Sciences s.r.o.
Gilead Sciences
The withdrawal letter is available here.
Dopis povlačenja dostupan je ovdje.
25 July 2014 EMEA/H/C/002418
EMEA/H/C/002418
It was to be available as 40 mg tablets.
Trebao je biti dostupan kao tablete od 40 mg.
The Committee considered that controls to ensure suitable and consistent quality of the medicine have not been shown to be adequate.
Povjerenstvo je bilo zabrinuto da kontrole za osiguravanje primjerene i konzistentne kvalitete lijeka nisu dokazane u dostatnoj mjeri.
If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Ako sudjelujete u kliničkom ispitivanju ili programu milosrdnog davanja lijekova te Vam je potrebno više informacija o Vašem liječenju, obratite se liječniku koji Vam pruža liječenje.
Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Dva lijeka su bioekvivalenti ako proizvode iste razine djelatne tvari u tijelu.
More information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Više informacija o označavanju lijeka kao lijeka za liječenje rijetkih i teških bolesti dostupno je ovdje: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
This means that it was intended to be similar to a ‘reference medicine' containing the same active substance, but in a higher strength.
To znači da je predviđen za sličnu primjenu kao „referentni lijek” i sadrži iste djelatne tvari, samo jače.
In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing the application since it would not be possible to provide the additional data regarding the quality of the medicine within the timetable required by the procedure.
U dopisu tvrtke kojim se Agencija obavještava o povlačenju zahtjeva, tvrtka je navela da povlači prijavu budući da nije bilo moguće dostaviti dodatne podatke u vezi s kvalitetom lijeka unutar vremenskog okvira propisanog postupkom.
Neofordex was developed as a ‘hybrid medicine'.
Neofordex je razvijen kao „hibridni lijek”.
What is Neofordex?
Što je Neofordex?
In addition, by providing a high dose in a single tablet Neofordex was expected to simplify dosing.
Nadalje, osiguravanjem visoke doze u jednoj tableti lijeka Neofordex očekivalo se pojednostavljivanje doziranja.
Therefore, up to the time of the withdrawal, the CHMP was of the opinion that due to the concerns about quality the benefits of Neofordex did not outweigh its risks.
Stoga je, do trenutka povlačenja, CHMP bio mišljenja da zabrinutost o kvaliteti prednosti lijeka Neofordex ne nadmašuju rizike.
While the reference medicine Dectancyl is available as 0.5 mg tablets, Neofordex was to be available as 40 mg tablets.
Dok je lijek Dectancyl dostupan kao tablete od 0,5 mg, Neofordex je bio dostupan kao tablete od 40 mg.
On 17 July 2014, Laboratories CTRS officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Neofordex, for the treatment of multiple myeloma.
Dana 17. srpnja 2014, Laboratories CTRS službeno je obavijestio Odbor za humane lijekove (CHMP) kako želi povući svoju prijavu za odobrenje za stavljanje u promet za Neofordex, za liječenje multipla mijeloma.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes using Neofordex.
Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su trenutno uključeni u klinička ispitivanja ili programe milosrdnog davanja lijeka Neofordex.
The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Prijava je povučena nakon što je CHMP ocijenio inicijalnu dokumentaciju koju je tvrtka dostavila te je sastavio popis pitanja.
The active substance in Neofordex and Dectancyl, dexamethasone, belongs to a group of medicines known as corticosteroids, which reduce the activity of the immune system (the body's natural defences) by attaching to receptors in various types of immune cells.
Djelatna tvar lijekova Neofordex i Dectancyl, deksametazon, ubrajaju se u grupu lijekova poznatih kao kortikosteroidi, koji smanjuju djelovanje imunosnog sustava (prirodnih obrana tijela) vezivanjem na receptore u različitim tipovima imunosnih stanica.
Neofordex was to be used in combination with other medicines to treat adult patients with multiple myeloma who have developed symptoms.
Neofordex se trebao koristiti u kombinaciji s drugim lijekovima za liječenje odraslih bolesnika oboljelih od multipla mijeloma u kojih su se razvili simptomi.
Because Neofordex was assessed as a hybrid medicine, and the effects of high-dose dexamethasone in multiple myeloma are well established, the company presented the results of a study carried out to investigate whether it is bioequivalent to the reference medicine, Dectancyl.
Budući da je Neofordex ocijenjen kao hibridni lijek, a djelovanje velikih doza deksametazona u slučaju multipla mijeloma je dobro utvrđeno, tvrtka je predstavila rezultate ispitivanja provedenog kako bi se istražilo je li ovaj lijek bioekvivalentan referetnom lijeku, Dectancyl.
The company also presented studies from the literature on the use of dexamethasone for the treatment of multiple myeloma.
Tvrtka je također dostavila ispitivanja iz literature o primjeni deksametazona za liječenje multipla mijeloma.
Multiple myeloma is a cancer of the plasma cells in the bone marrow.
Multipli mijelom je rak stanica plazme u koštanoj srži.
Withdrawal of the marketing authorisation application for Neofordex (dexamethasone) EMA/443387/2014
(deksametazon) EMA/443387/2014
Withdrawal of the marketing authorisation application for Neofordex (dexamethasone)
Povlačenje zahtjeva za davanje odobrenja za stavljanje u promet lijeka Neofordex (deksametazon)
The company had not yet responded to the last round of questions at the time of the withdrawal.
U trenutku povlačenja tvrtka još nije bila dostavila svoje odgovore.
Neofordex is a corticosteroid medicine that contains the active substance dexamethasone.
Neofordex je kortikosteroid koji sadrži djelatnu tvar deksametazon.
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Neofordex could not have been approved for the treatment of multiple myeloma.
Na temelju pregleda podataka te odgovora tvrtke na popise pitanja CHMP-a, u trenutku povlačenja, CHMP je izrazio svoju zabrinutost oko određenih pitanja te je njegovo privremeno mišljenje bilo da je moguće dati odobrenje za Neofordex za liječenje multipla mijeloma.
What was Neofordex expected to be used for?
Za što se Neofordex trebao koristiti?
Neofordex was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 6 June 2010 for the treatment of multiple myeloma.
Neofordex je označen kao lijek za liječenje rijetkih i teških bolesti dana 6. lipnja 2010. za liječenje multipla mijeloma.
How is Neofordex expected to work?
Kako je Neofordex trebao djelovati?
dexamethasone is used together with chemotherapy to make chemotherapy more effective and to reduce certain side effects of cancer treatment, such as nausea (feeling sick) and vomiting.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom smanjile određene nuspojave liječena raka, poput mučnine (osjećaja slabosti) i povraćanja.