natgillin/translations-raw huggingface dataset:
This product should only be used after it has been demonstrated that very virulent IBDV strains are epidemiologically relevant in the area of vaccination.
Ovaj se proizvod smije upotrebljavati isključivo nakon što je utvrđeno da su vrlo virulentni sojevi IBDV-a (virusa zarazne bolesti burze) epidemiološki relevantni u području cijepljenja.
The vaccine contains an intermediate-plus IBDV strain bound to specific IBDV immunoglobulins, forming an immune-complex which is administered through vaccination.
Cjepivo sadrži intermedijarni IBDV soj vezan na specifične IBDV imunoglobuline, formirajući imunološki kompleks koji se primjenjuje cijepljenjem.
Appropriate veterinary and husbandry measures should be taken to avoid spread of the vaccine strain to susceptible wild and domestic birds.
Treba poduzeti odgovarajuće veterinarske i uzgojne mjere kako bi se izbjeglo širenje cjepnog soja na podložne divlje i domaće ptice.
It is important to note that the volumes of solvent which must be used to reconstitute the vaccine are different depending on whether the vaccine will be administered in ovo to embryonated eggs, or by subcutaneous injection to 1-day-old chicks.
Važno je napomenuti da su volumeni otapala koji se moraju upotrijebiti za rekonstituciju cjepiva različiti ovisno o tome da li će se cjepivo davati in ovo embrioniranim jajima, ili subkutanom injekcijom jednodnevnim pilićima.
The reconstituted vaccine is a slightly reddish homogeneous suspension which should be used within 2 hours after reconstitution.
Rekonstituirano cjepivo je blago crvenkasta homogena suspenzija koju treba upotrijebiti unutar 2 sata nakon pripreme.
An automated egg injection machine can be used.
Može se koristiti automatizirani injektor za ubrizgavanje jaja.
Wash and disinfect hands after handling vaccinated birds or their litter because the virus is excreted by vaccinated birds for up to 3 weeks.
Operite i dezinficirajte ruke nakon rukovanja s cijepljenim pticama ili njihovim leglom jer cijepljene ptice izlučuju virus do 3 tjedna.
Vaccinated birds may excrete the vaccine strain up to 3 weeks following vaccine take.
Cijepljene ptice mogu izlučivati cjepni soj do 3 tjedna nakon uzimanja cjepiva.
EXP {month/year} Once reconstituted use within 2 hours.
EXP {mjesec/godina} Nakon rekonstitucije upotrijebite unutar 2 sata.
Pharmacotherapeutic group: Immunologicals for aves, domestic fowl, live viral vaccines, avian infectious bursal disease virus (Gumboro disease).
Farmakoterapijska grupa: Imunološki proizvodi za ptice, domaću perad, živa virusna cjepiva, virus zarazne bolesti burze (gumborska bolest).
Solvent volume to be used:
Volumen otapala koji se koristi:
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with this veterinary medicinal product.
Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim otapalom priloženim za primjenu s ovim veterinarsko-medicinskim proizvodom.
Mix the contents of the vial by gentle agitation until the contents are completely resuspended, then withdraw the suspension obtained and inject it into the solvent bag.
Miješajte sadržaj bočice laganim miješanjem dok se sadržaj potpuno ne suspendira, zatim izvucite dobivenu suspenziju i ubrizgajte je u vrećicu s otapalom.
Disodium phosphate dodecahydrate Potassium dihydrogen phosphate Potassium chloride Sodium chloride
Dinatrij fosfat dodekahidrat Kalijev dihidrogen fosfat Kalijev klorid Natrijev klorid
Do not store above 25 °C.
Nemojte čuvati pri temperaturi iznad 25 °C.
To stimulate active immunity against very virulent bursal disease viruses (Gumboro disease) in broiler chickens.
Stimulirati aktivnu imunost protiv virulentnih virusa burze (gumborska bolest) kod pilića brojlera.
Shelf life of the solvent as packaged for sale: 3 years.
Rok valjanosti otapala zapakiranog za prodaju: 3 godine.
1,000 doses 2,000 doses 2,500 doses 4,000 doses 5,000 doses
1000 doza 2000 doza 2500 doza 4000 doza 5000 doza
Solvent: Polypropylene bags containing 200 ml, 400 ml, 800 ml or 1,000 ml.
Polipropilenske vrećice koje sadrže 200 ml, 400 ml, 800 ml ili 1000 ml.
The vaccine (0.05 ml dose) must be injected into the amniotic sac of 18-day-old embryonated broiler chicken eggs.
Cjepivo (0,05 ml doza) mora se ubrizgati u amnionsku vrećicu 18-dnevnih embrioniranih kokošjih jaja brojlera.
For active immunisation of 1-day-old broiler chicks and embryonated broiler chicken eggs to reduce clinical signs and lesions of the bursa of Fabricius caused by very virulent avian infectious bursal disease virus infection.
Za aktivnu imunizaciju jednodnevnih pilića i embrioniranih jaja brojlera za smanjivanje kliničkih znakova i lezija Fabricijeve burze uzrokovane vrlo virulentnom infekcijom virusom zarazne bolesti burze.
The efficacy of the vaccine has been demonstrated in broilers having an average MDA level from 4,500 to 5,100 ELISA units at hatching.
Učinkovitost cjepiva pokazana je kod brojlera koji imaju prosječni titar MDA od 4,500 do 5,100
An automated syringe can be used.
Može se koristiti automatski injektor.
Do not use in birds in lay or breeding birds, or within 4 weeks before the start of the laying period.
Ne primjenjivati na nesilicama za vrijeme nesenja ili pticama za rasplod ili 4 tjedna prije početka nesenja.
Solvent: clear colourless solution.
Otapalo: bistra bezbojna otopina.
The vaccine (0.2 ml dose) must be injected under the skin of the neck of the 1-day-old broiler chicks.
Cjepivo (doza od 0,2 ml) mora se ubrizgati pod kožu vrata jednodnevnih tovnih pilića.
Repeat step 2 to ensure that all the lyophilisate has been transferred into the solvent bag.
Ponovite korak 2 kako biste bili sigurni da je sav liofilizat prenesen u vrećicu s otapalom.
Type I glass vials closed with Type I bromobutyl stoppers and sealed with aluminium caps containing 1,000 doses, 2,000 doses, 2,500 doses, 4,000 doses or 5,000 doses of the freeze-dried vaccine.
I i zapečaćene aluminijskim kapicama koje sadrže 1000 doza, 2000 doza, 2500 doza, 4000 doza ili 5000 doza liofiliziranog cjepiva.
The safety of the veterinary medicinal product has not been established during lay.
Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena za vrijeme nesenja.
In laboratory studies, lymphocyte depletion was very common after vaccine take, which was followed by a lymphocyte repopulation and regeneration of the bursa of Fabricius.
U laboratorijskim ispitivanjima limfocitna deplecija bila je vrlo česta nakon uzimanja cjepiva, nakon čega je uslijedila repopulacija limfocita i regeneracija Fabricijeve burze.
Withdraw 2 ml of the solvent and inject into the vial containing the lyophilisate.
Izvucite 2 ml otapala i ubrizgajte u bočicu koja sadrži liofilizat.
Solvent: Do not store above 25 ºC.
Otapalo: Nemojte čuvati pri temperaturi iznad 25 °C.
10 x 1,000 doses 10 x 2,000 doses 10 x 2,500 doses 10 x 4,000 doses 10 x 5,000 doses
10 x 1000 doza 10 x 2000 doza 10 x 2500 doza 10 x 4000 doza 10 x 5000 doza
In laboratory studies, lymphocyte depletion was very common, followed by a lymphocyte repopulation and regeneration of the bursa of Fabricius.
U laboratorijskim ispitivanjima, limfocitna deplecija bila je vrlo česta, nakon čega je uslijedila repopulacija limfocita i regeneracija Fabricijeve burze.
Each dose of reconstituted vaccine (0.05 ml for an in ovo dose or 0.2 ml for a subcutaneous dose) contains:
Svaka doza rekonstituiranog cjepiva (0,05 ml za dozu in ovo ili 0,2 ml za potkožnu dozu) sadrži:
Live attenuated infectious bursal disease virus (IBDV), strain 1052……….. 101.48 - 102.63 PU* * PU: Potency Units
Živi atenuirani virus zarazne bolesti burze (IBDV), soj 1052 …............… 101,48 - 102,63 PU* * PU: Jedinice potencije
* PU: Potency Units
** VNU: Jedinice neutralizacije virusa
Live attenuated infectious bursal disease virus (IBDV), strain 1052….. 10
Živi atenuirani virus zarazne bolesti burze (IBDV), soj 1052………..
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Lyophilisate vial
OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČI BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA
Lyophilisate: brown reddish colour.
Liofilizat: smeđe crvenkasta boja.
Rinse the vial with another 2 ml of the solvent/lyophilisate suspension obtained in step 1, and inject it back into the solvent bag.
Isperite bočicu s još 2 ml otapala/suspenzije liofilizata dobivenih u koraku 1 i ubrizgajte je natrag u vrećicu s otapalom.
By the subcutaneous route: Administer one single injection of 0.2 ml of the reconstituted vaccine to each chick at 1 day of age.
Primjena pod kožu: Primijenite jednu injekciju od 0,2 ml rekonstituiranog cjepiva svakom jednodnevnom piliću.
After the administration of a 10-fold overdose, a mild exudate and slight congestion in the bursa of Fabricius were very commonly observed.
Nakon primjene 10-strukog predoziranja, vrlo često su zabilježeni blagi eksudat i lagana kongestija u
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes (lyophilisate vials)
Kartonske kutije (bočice liofilizata)
By the in ovo route: Administer one single injection of 0.05 ml of the reconstituted vaccine into each chicken egg at 18 days of embryonation.
Primjena in ovo: Primijenite jednu injekciju od 0,05 ml rekonstituiranog cjepiva u svako 18 dana staro embrionirano jaje.
Disposal: read package leaflet supplied with the lyophilisate vial.
Prije uporabe pročitajte uputu o lijeku dostavljenu s bočicom za liofilizat.
In ovo or subcutaneous use.
In ovo ili primjena pod kožu.
la Selva, 135 Amer, 17170 Girona Spain
Laboratorios Hipra, S.A. Avda. la Selva, 135 Amer, 17170 Girona Spain
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
PROIZVOĐAČI BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČ
Lyophilisate for suspension for injection.
Liofilizat za suspenziju za injekciju.
Lyophilisate:
Doziranje:
GUMBOHATCH lyophilisate for suspension for injection for chickens
GUMBOHATCH liofilizat za suspenziju za injekcije za piliće
PACKAGE LEAFLET: GUMBOHATCH lyophilisate and solvent for suspension for injection for chickens
UPUTA O VMP: GUMBOHATCH liofilizat i otapalo za suspenziju za injekciju za piliće
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Solvent bag
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU
Each dose (0.05 ml for in ovo or 0.2 ml for SC) contains: Live attenuated IBDV, strain 1052…………….. 101.48 - 102.63 PU* * PU: Potency Units
Svaka doza (0,05 ml za in ovo ili 0,2 ml za SC) sadrži: Živi atenuirani IBDV, soj 1052……………..
Dilutions for subcutaneous administration (0.2 ml per dose) Number and content of vaccine vials:
Razrjeđenja za supkutanu primjenu (0,2 ml po dozi):
Solvent for suspension for injection.
Otapalo za suspenziju za injekciju.
Cardboard box with 10 bags containing 1,000 ml solvent.
Kartonska kutija s 10 vrećica koje sadrže 1000 ml otapala.
Reconstitution of the vaccine:
Rekonstitucija cjepiva:
la Selva, 135 Amer, 17170 (Girona) Spain
Laboratorios Hipra, S.A. Avda. la Selva, 135 Amer, 17170 (Girona) Spain
Cardboard box with 10 lyophilisate vials containing 2,500 doses.
Kartonska kutija s 10 liofiliziranih bočica koje sadrže 2500 doza.
For in ovo administration:
Za primjenu pod kožu:
Cardboard box with 10 bags containing 200 ml solvent.
Kartonska kutija s 10 vrećica koje sadrže 200 ml otapala.
GUMBOHATCH lyophilisate and solvent for suspension for injection for chickens
GUMBOHATCH liofilizat i otapalo za suspenziju za injekciju za piliće
Cardboard box with 10 bags containing 400 ml solvent.
Kartonska kutija s 10 vrećica koje sadrže 400 ml otapala.
Cardboard box with 10 bags containing 800 ml solvent.
Kartonska kutija s 10 vrećica koje sadrže 800 ml otapala.
Tel: +39 030 7241821
Hipra Italia S.r.l. Tel: +39 030 7241821
HIPRA UK AND IRELAND, Ltd. Tel: +44-(0)11 5845 6486
Tel: +44-(0)11 5845 6486
Dilutions for subcutaneous administration (0.2 ml per dose): Number and content of vaccine vials:
Izračunajte i pripremite potreban volumen cjepiva prema tabeli u nastavku: Razrjeđenja za supkutanu primjenu (0,2 ml po dozi): Broj i sadržaj bočica cjepiva:
Cardboard box with 10 lyophilisate vials containing 1,000 doses.
Kartonska kutija s 10 liofiliziranih bočica koje sadrže 1000 doza.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes (solvent bags)
Kartonske kutije (vrećice za otapalo)
Cardboard box with 10 lyophilisate vials containing 5,000 doses.
Kartonska kutija s 10 liofiliziranih bočica koje sadrže 5000 doza.
Cardboard box with 10 lyophilisate vials containing 4,000 doses.
Kartonska kutija s 10 liofiliziranih bočica koje sadrže 4000 doza.
Cardboard box with 10 lyophilisate vials containing 2,000 doses.
Kartonska kutija s 10 liofiliziranih bočica koje sadrže 2000 doza.
la Selva, 135
LABORATORIOS HIPRA, S.A. Avda. la Selva, 135
Hipra Italia S.r.l.
HIPRA UK AND IRELAND, Ltd.
Avda.
Tel.
Solvent:
Liofilizat:
Dilutions for in ovo administration (0.05 ml per dose) Number and content of vaccine vials:
Razrjeđenja za davanje in ovo (0,05 ml po dozi):
IBDV-specific antibody solution…………………………….. 2.7x106 VNU** of IgY per vial **VNU: Virus Neutralisation Units
2,7x106 VNU** of IgY po bočici
B. PACKAGE LEAFLET
Bočica liofilizata
Marketing authorisation holder and manufacturer responsible for batch release: Laboratorios Hipra, S.A.
Nositelj odobrenja za stavljanje u promet i proizvođač odgovoran za puštanje serije u promet:
IBDV-specific antibody solution………………………………2.7x106 VNU** of IgY per vial **VNU: Virus Neutralisation Units
Pomoćne tvari: IBDV-specifična otopina antitijela……………………..
Solution for injection/infusion
Otopina za injekciju/infuziju
50 ml
Bočica (staklena) 50ml
The recommended dose is one tablet once a day and it must be taken with food.
Preporučena doza je jedna tableta dnevno, a mora se uzimati s hranom.
The full EPAR for Eviplera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Cjeloviti EPAR nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
All three active substances are already available in separate medicines in the EU.
Sve tri djelatne tvari već su dostupne u EU-u u zasebnim lijekovima.
The European Commission granted a marketing authorisation valid throughout the European Union for Eviplera on 28 November 2011.
Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Eviplera vrijedi na prostoru Europske unije od 28. studenoga 2011.
It is available as tablets.
Dostupan je u obliku tableta.
Patients who have HIV and hepatitis B may see a worsening of their liver problems when stopping Eviplera.
Bolesnici koji imaju HIV i hepatitis B mogu uočiti pogoršanje svojih problema s jetrom kada prestanu uzimati lijek Eviplera.
It also causes fewer side effects in the early stages of treatment and offers the benefit of being taken as one tablet once per day.
Također uzrokuje manje nuspojava u ranim stadijima liječenja i nudi pogodnost uzimanja jedne tablete dnevno.
What measures are being taken to ensure the safe and effective use of Eviplera?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Eviplera?
Eviplera must not be used with the following medicines as they may lead to reduced blood levels of rilpivirine, and thereby reduce the effectiveness of Eviplera:
Eviplera se ne smije koristiti sa sljedećim lijekovima jer oni mogu uzrokovati smanjene razine rilpivirina u krvi i tako umanjiti djelotvornost lijeka Eviplera:
Eviplera does not cure HIV-1 infection or AIDS, but it may slow the damage to the immune system and the development of infections and diseases associated with AIDS.
Eviplera ne liječi infekciju virusom HIV-1 niti AIDS, ali može usporiti oštećenje imunološkog sustava i razvoj infekcija i bolesti povezanih s AIDS-om.
For more information about treatment with Eviplera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Eviplera pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
If Eviplera is given together with rifabutin, the doctor should prescribe an additional 25 mg of rilpivirine per day during rifabutin treatment.
Ako se Eviplera daje zajedno s rifabutinom, liječnik treba propisati dodatnih 25 mg rilpivirina dnevno tijekom liječenja rifabutinom.
This is a summary of the European public assessment report (EPAR) for Eviplera.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Eviplera.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Eviplera.
Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Eviplera.
By blocking this enzyme, Eviplera reduces the amount of HIV-1 in the blood and keeps it at a low level.
Inhibiranjem tog enzima Eviplera smanjuje količinu virusa HIV-1 u krvi i održava je niskom.
Other information about Eviplera
Ostale informacije o lijeku Eviplera
Eviplera emtricitabine / rilpivirine / tenofovir disoproxil
Eviplera emtricitabin/rilpivirin/tenofovirdizoproksil
Eviplera is a medicine that contains the active substances emtricitabine (200 mg), rilpivirine (25 mg) and tenofovir disoproxil (245 mg).
Eviplera je lijek koji sadrži djelatne tvari emtricitabin (200 mg), rilpivirin (25 mg) i tenofovirdizoproksil (245 mg).
The company also presented studies showing that the tablet containing all three substances is absorbed in the body in the same way as the separate tablets given concurrently under similar conditions.
Proizvođač lijeka također je predočio ispitivanja koja pokazuju da se tableta koja sadrži sve tri tvari apsorbira u tijelu na isti način kao i zasebne tablete koje se daju istovremeno pod sličnim uvjetima.
However, the CHMP noted that there was some risk of HIV-1 developing resistance to rilpivirine and that this risk appeared to be lower in patients with a lower viral load.
No CHMP je napomenuo da postoji određeni rizik da HIV-1 razvije otpornost na rilpivirin te da se čini da je taj rizik manji u bolesnika s nižim virusnim opterećenjem.
If patients need to stop taking one of the active substances or if they need to modify their dose, patients should be switched to separate medicines containing emtricitabine, rilpivirine or tenofovir disoproxil.
Ako bolesnici moraju prestati uzimati jednu od djelatnih tvari ili ako moraju promijeniti dozu, potrebno ih je prebaciti na zasebne lijekove koji sadrže emtricitabin, rilpivirin i tenofovirdizoproksil.
• systemic dexamethasone (a steroid anti-inflammatory and immunosuppressant medicine) except when used as a single dose treatment;
• sistemski deksametazon (steroidni protuupalni lijek i imunosupresant), osim ako se primjenjuje kao terapija jednokratnom dozom;
Treatment with Eviplera should be started by a doctor who has experience in the management of HIV infection.
Liječenje lijekom Eviplera treba započeti liječnik koji ima iskustva u liječenju infekcija HIV-om.
The main measure of effectiveness was based on the reduction in viral load.
Glavno mjerilo djelotvornosti temeljilo se na smanjenju virusnog opterećenja.
All three active substances block the activity of reverse transcriptase, a viral enzyme that allows HIV-1 to replicate in the cells it has infected.
Sve tri djelatne tvari onemogućuju djelovanje reverzne transkriptaze, virusnog enzima koji omogućuje replikaciju virusa HIV-1 u zaraženim stanicama.
What is Eviplera?
Što je Eviplera?
• omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors for reducing stomach acid);
• omeprazol, esomeprazol, lansoprazol, pantoprazol, rabeprazol (inhibitori protonske crpke za smanjivanje lučenja želučane kiseline);
It is only used in patients where the virus has not developed resistance to certain anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs), tenofovir or emtricitabine, and who have HIV levels in the blood (viral load) of no more than 100,000 HIV-1 RNA copies/ml.
Koristi se samo u bolesnika kod kojih virus nije razvio otpornost na određene lijekove protiv HIV-a zvane nenukleozidni inhibitori reverzne transkriptaze (NNRTI), tenofovir ili emtricitabin, te kod kojih razina HIV-a u krvi (virusno opterećenje) nije veća od 100 000 HIV-1 RNK kopija/ml.
What is the risk associated with Eviplera?
Koji su rizici povezani s lijekom Eviplera?
Eviplera is used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Eviplera se koristi u liječenju odraslih osoba zaraženih virusom humane imunodeficijencije-1 (HIV-1) koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
The two studies evaluating the effects of switching patients to Eviplera showed that Eviplera was as effective as the previous treatment and maintained the reduction in viral load.
Dva ispitivanja u kojima su procijenjeni učinci prelaska bolesnika na lijek Eviplera pokazala su da je lijek Eviplera bio jednako djelotvoran kao i prethodna terapija te da je održano smanjenje virusnog opterećenja.
In the first main study involving 690 patients, Eviplera was compared with a similar combination that had efavirenz in place of rilpivirine.
U prvom glavnom ispitivanju kojim je bilo obuhvaćeno 690 bolesnika Eviplera je uspoređena sa sličnom kombinacijom koja je sadržavala efavirenc umjesto rilpivirina.
The second main study involving 678 patients compared rilpivirine with efavirenz, both being taken with emtricitabine and tenofovir disoproxil or two other nucleotide reverse transcriptase inhibitors.
U drugom glavnom ispitivanju kojim je bilo obuhvaćeno 678 bolesnika uspoređen je rilpivirin s efavirencom, pri čemu su oba uzimana s emtricitabinom i tenofovirdizoproksilom ili s druga dva nukleotidna inhibitora reverzne transkiptaze.
In the first study in previously untreated patients, 83% of the patients taking the Eviplera combination responded to treatment compared with 84% of the patients taking a combination with efavirenz.
U prvom ispitivanju kod bolesnika koji nisu prethodno liječeni, 83 % bolesnika koji su uzimali kombinaciju koja sadrži lijek Eviplera odgovorilo je na terapiju, u usporedbi s 84 % bolesnika koji su uzimali kombinaciju s efavirencom.
Eviplera has also been evaluated in 532 patients who were switched from their current HIV treatment to Eviplera.
Lijek Eviplera također je ocijenjen u 532 bolesnika koji su prebačeni s postojeće terapije protiv HIV-a na lijek Eviplera.
The CHMP concluded that Eviplera was as effective as combinations containing efavirenz.
CHMP je zaključio da je lijek Eviplera jednako djelotvoran kao i kombinacije koje sadrže efavirenc.
Therefore, the CHMP considered that the benefits of Eviplera outweigh its risks in patients with a low HIV-1 viral load, and recommended that it be granted marketing authorisation for this group of patients.
Stoga CHMP smatra da koristi od lijeka Eviplera nadmašuju s njime povezane rizike u bolesnika s niskim opterećenjem virusom HIV-1 te je preporučio izdavanje odobrenja za stavljanje lijeka u promet za tu skupinu bolesnika.
What benefit has Eviplera shown during the studies?
Koje su koristi lijeka Eviplera dokazane u ispitivanjima?
Eviplera contains three active substances: emtricitabine, which is a nucleoside reverse transcriptase inhibitor; rilpivirine, which is a non-nucleoside reverse transcriptase inhibitor (NNRTI); and tenofovir disoproxil, which is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Eviplera sadrži tri djelatne tvari: emtricitabin, koji je nukleozidni inhibitor reverzne transkriptaze, rilpivirin, koji je nenukleozidni inhibitor reverzne transkriptaze (NNRTI), te tenofovirdizoproksil, koji je „prolijek” tenofovira, što znači da se u tijelu pretvara u djelatnu tvar tenofovir.
The main measure of effectiveness was based on the maintained reduction in viral load.
Glavno mjerilo djelotvornosti temeljilo se na zadržanom smanjenju virusnog opterećenja.