natgillin/translations-raw huggingface dataset:
The incidence of serious adverse reactions in the Nerlynx arm vs placebo arm was 7.0% vs. 5.7% (<65 years-old) and 9.9% vs. 8.1% (≥65 years-old).
Incidencija ozbiljnih nuspojava u skupini liječenoj lijekom Nerlynx u odnosu na skupinu koja je primala placebo iznosila je 7,0 % u odnosu na 5,7 % (<65 godina) te 9,9 % u odnosu na 8,1 %
1 Includes stomatitis, aphthous stomatitis, mouth ulceration, oral mucosal blistering, and mucosal inflammation.
1 Obuhvaća stomatitis, aftozni stomatitis, ulkuse u ustima, plikove na oralnoj sluznici i upalu sluznice.
Hormone receptor positive population who are less than one year from completion of trastuzumab
Populacija s bolesti pozitivnom na hormonske receptore koja je završila liječenje trastuzumabom prije manje od godinu dana
Women of childbearing potential/Contraception in females and males Based on findings in animals, neratinib may cause foetal harm when administered to pregnant women.
Na temelju rezultata ispitivanja na životinjama, neratinib može štetno djelovati na fetus kada se primjenjuje u trudnica.
Adverse drug reactions due to Nerlynx in monotherapy breast cancer studies
Tablica 5: Nuspojave kod uzimanja lijeka Nerlynx u ispitivanjima monoterapijskog liječenja raka dojke
240 mg daily
240 mg dnevno
Hepatotoxicity has been reported in patients treated with Nerlynx.
U bolesnika liječenih lijekom Nerlynx prijavljena je hepatotoksičnost.
The diarrhoea may be severe, and you may get dehydrated.
Proljev može biti težak i može doći do dehidracije.
Dose modifications for diarrhoea
Prilagodbe doza zbog nuspojava
This helps to stop the cells from dividing and growing.
To pomaže u zaustavljanju podjele i rasta stanica raka.
Nerlynx is used for patients who have early stage breast cancer which: - is human epidermal growth factor receptor 2-positive (HER2-positive) and - has previously been treated with another medicine called ‘trastuzumab'.
Nerlynx se primjenjuje u bolesnika s rakom dojke u ranoj fazi koji: - je pozitivan na receptor humanog epidermalnog faktora rasta 2 (HER2) i
>=4 Positive Nodes
≥4 pozitivna čvora
* Per CTCAE v4.0 † Complicated features include dehydration, fever, hypotension, renal failure, or Grade 3 or 4 neutropenia ‡ Despite being treated with optimal medical therapy
† Složene značajke obuhvaćaju dehidraciju, vrućicu, hipotenziju, zatajenje bubrega ili neutropeniju 3. ili
Co-administration with moderate CYP3A4/P-gp inhibitors:
Istodobna primjena s umjerenim inhibitorima CYP3A4/P-gp:
• Key messages on how to prevent and minimise GI toxicity through appropriate monitoring (with reference to treatment journal) and management: o prophylactic treatment with antidiarrhoeal medicinal product o dietary changes o when to alert HCP and the importance of it for further treatment adjustment
• Ključne poruke o načinu sprječavanja i svođenja gastrointestinalne toksičnosti na najmanju moguću mjeru putem prikladnog praćenja (uz upućivanje na dnevnik liječenja) i zbrinjavanja:
Nerlynx should not be used during pregnancy unless the clinical condition of the woman requires treatment with neratinib.
Osim ako kliničko stanje žene zahtijeva liječenje neratinibom, Nerlynx se ne smije uzimati tijekom trudnoće.
Primary efficacy analyses - ITT and hormone receptor positive populations who are less than one year from completion of trastuzumab therapy
Tablica 6: Primarne analize djelotvornosti - ITT populacija i populacija s bolesti pozitivnom na hormonske receptore koje su završile liječenje trastuzumabom prije manje od godinu dana Varijabla
• Grade 3 bilirubin (>3-10 x ULN)
• Bilirubin 3. stupnja (>3-10 x GGN)
• Grade 4 ALT (>20 x ULN)
• ALT 4. stupnja (>20 x GGN)
120 mg daily
120 mg dnevno
Carcinogenesis, mutagenesis Nerlynx was neither clastogenic nor mutagenic in the standard battery of genotoxicity studies.
Nerlynx se nije pokazao klastogenim ili mutagenim.
In the pivotal phase III study, ExteNET (3004), the frequency of Treatment Emergent Adverse Events (TEAEs) in the Skin and Subcutaneous Disorders System Organ Class (SOC) in Asian patients treated with Nerlynx was higher than in Caucasian patients (56.4% vs. 34.5%) but comparable in placebo patients (24.9% vs. 22.8%).
Organ Class, SOC) poremećaja kože i potkožnog tkiva u Azijata liječenih lijekom Nerlynx bila je viša nego u bijelaca (56,4 % u odnosu na 34,5 %), ali usporediva u bolesnika koji su primali placebo (24,9 % u odnosu na 22,8 %).
Guidelines for dose adjustment of Nerlynx in the event of liver toxicity are shown in Table 4.
Prilagodbe doze za hepatotoksičnost U tablici 4 prikazane su smjernice za prilagodbu doza lijeka Nerlynx u slučaju hepatotoksičnosti
Nerlynx is for oral use.
Način primjene Nerlynx je namijenjen za peroralnu primjenu.
Women who can become pregnant must use an effective method of contraception, including a barrier method: - while taking Nerlynx and - for one month after treatment has finished.
Žene reproduktivne dobi moraju koristiti učinkovitu metodu kontracepcije, uključujući mehaničku metodu: - tijekom uzimanja lijeka Nerlynx i
Co-administration of a single oral dose of 240 mg of neratinib in the presence of ketoconazole (400 mg once daily for 5 days), a strong CYP3A4/P-gp inhibitor, increased neratinib systemic exposure.
(400 mg jednom dnevno tijekom 5 dana), snažnog inhibitora CYP3A4/Pgp, povećala je sistemsku izloženost neratinibu.
160 mg daily
160 mg dnevno
Guidelines for adjusting doses of Nerlynx in the setting of diarrhoea are shown in Table 3.
U tablici 3 prikazane su smjernice za prilagodbu doza lijeka Nerlynx kod zbrinjavanja proljeva.
Stop Nerlynx until recovery to Grade ≤1 or baseline within 3 weeks of stopping treatment.
≤1. stupanj ili polazno stanje u roku od 3 tjedna od prekida liječenja.
• Grade 4 bilirubin (>10 x ULN)
• Bilirubin 4. stupnja (>10 x GGN)
• Remark on importance of reading the PIL • Remarks on the importance of reporting ADRs
• Napomene o važnosti prijavljivanja nuspojava lijeka
A single oral dose of 240 mg neratinib taken with a meal high in fat increased both Cmax and AUC by approximately 100%.
Pojedinačna peroralna doza od 240 mg neratiniba uzeta uz obrok bogat masnoćama povećala je Cmax i
The patient information pack should contain: o Patient information leaflet o A patient/carer treatment guide o “My Treatment Journal” The Patient/carer guide shall contain the following key messages (in lay language)
Vodič za liječenje za bolesnika/njegovatelja mora sadržavati sljedeće ključne poruke (u laičkim izrazima) • Naziv lijeka, djelatnu tvar i odobrenu indikaciju lijeka
Elderly In the pivotal phase III study, ExteNET (3004), the mean age was 52 years in the Nerlynx arm,
U ključnom ispitivanju faze III, ExteNET (3004), učestalost štetnih događaja nastalih tijekom liječenja
An HDPE desiccant canister with 1 g silica gel is enclosed with the tablets in each bottle.
U svakoj se bočici s tabletama nalazi spremnik od HDPE-a s 1 g silika gela.
1 vs. 4
1 u odnosu na 4
200 mg daily
200 mg dnevno
Variable
OBLIK
Each film coated tablet contains neratinib maleate equivalent to 40 mg neratinib.
Jedna filmom obložena tableta sadrži neratinibmaleat u količini koja odgovara 40 mg neratiniba.
• Permanently discontinue Nerlynx treatment
• Trajno prekinuti liječenje lijekom Nerlynx
Distant disease-free survival Time to distant recurrence CNS recurrence
Razdoblje do recidiva bolesti na udaljenom mjestu
Very common: may affect more than 1 in 10 people - diarrhoea - stomach pain, feeling or being sick, low appetite - dry or inflamed mouth, including blisters or mouth ulcers - rash - muscle spasms or cramps - feeling very tired
- bol u trbuhu, osjećaj mučnine ili povraćanje, smanjeni apetit - suha ili upaljena usta, uključujući mjehuriće ili ulkuse u ustima
Co-administration with proton pump inhibitors (PPIs) and H2-receptor antagonists is not recommended.
Ne preporučuje se istodobna primjena s inhibitorima protonske pumpe (PPI) i antagonistima
26 vs. 55
26 u odnosu na
7 vs. 20
7 u odnosu na
• Grade 3 diarrhoea lasting between 2 days and 3 weeks‡
• Proljev 3. stupnja koji traje između
What Nerlynx is and what it is used for 2.
Što je Nerlynx i za što se koristi
Uncommon: may affect up to 1 in 100 people - kidney failure - changes in liver blood test results (i.e., blood bilirubin increased)
- promjene u rezultatima krvnih pretraga jetrene funkcije (tj. povećanje bilirubina u krvi)
P-value3
Pvrijednost3
• Permanently discontinue Nerlynx • Evaluate alternative causes
• Ocijeniti alternativne uzroke
• If diarrhoea resolves to Grade 0-1 in one week or less, then resume Nerlynx treatment at the same dose.
• Potrebno je održavati unos tekućine od ~2 l kako bi se izbjegla dehidracija • Ako se težina proljeva smanji na 0.-1. stupanj u roku od tjedan dana ili manje, nastaviti liječenje lijekom Nerlynx u istoj dozi.
Following concomitant administration with repeated doses of 600 mg rifampicin, a strong CYP3A4/Pgp inducer, neratinib exposures were significantly decreased with mean values that were 24% and 13% of reference values (neratinib administered alone) for Cmax and AUC, respectively.
izloženosti neratinibu značajno su smanjene; srednje vrijednosti iznosile su 24 % i 13 % referentnih vrijednosti (neratinib primijenjen samostalno) za Cmax, odnosno AUC.
Talk to your doctor before taking Nerlynx if you are breast-feeding or plan to breast-feed because small amounts of this medicine may pass into your breast milk.
Budući da se male količine ovog lijeka mogu izlučiti u Vaše mlijeko, ako dojite ili planirate dojiti razgovarajte sa svojim liječnikom prije uzimanja lijeka Nerlynx.
o The Summary of Product Characteristics o Guide for healthcare professionals o Patient educational material The Guide for healthcare professionals shall contain the following key elements: o Name of the product, active substance and approved indication of the product o Relevant information on the safety concern “Gastrointestinal toxicity (diarrhoea)” (e.g. seriousness, severity, frequency, time to onset, duration, reversibility of the AE as applicable) o Details of the population at higher risk for the safety concern o Key message to convey in patients counselling on how to prevent and minimise Gastrointestinal toxicity through appropriate monitoring and management: o prophylactic treatment with antidiarrhoeal medicinal product o dietary changes o dose modification (with guideline to adjust doses)/ discontinuation of treatment o The importance of handing over the educational material to the patients/carers at the end of counselling o Remarks on the importance of reporting ADRs
o profilaktičko liječenje lijekom protiv proljeva o promjene u prehrani o prilagodba doze (sa smjernicama za prilagodbu doza)/prekid liječenja o Važnost davanja edukacijskog materijala bolesnicima/njegovateljima na kraju savjetovanja o Napomene o važnosti prijavljivanja nuspojava lijeka
19 vs. 35
19 u odnosu na
OR
o
The most common TEAEs in the Skin SOC that occurred more frequently in Asian patients than in Caucasian patients were rash (29.4% vs. 13.5%), Palmar-plantar erythrodysaesthesia syndrome (9.9% vs. 1.0%), and dermatitis acneiform (6.0 vs. 1.0%).
13,5 %), palmarno-plantarna eritrodisestezija (9,9 % u odnosu na 1,0 %) i akneiformni dermatitis (6,0 u odnosu na 1,0 %).
3 Includes nail disorder, paronychia, onychoclasis, and nail discolouration.
3 Obuhvaća poremećaj noktiju, paronihiju, onihoklaziju i promjenu boje na površini nokta.
The serious adverse reactions most frequently reported in the ≥65 years-old group were vomiting (2.3%), diarrhoea (1.7%), dehydration (1.2%), and renal failure (1.2%).
(2,3 %), proljev (1,7 %), dehidracija (1,2 %) i zatajenje bubrega (1,2 %).
Missed dose
Nuspojava lijeka
Grade 3 adverse reactions were reported in 1.6% vs 0.5% and Grade 4 adverse reactions were reported in 0.2% vs. 0.1%, Nerlynx- and placebo-treated patients, respectively.
Nuspojave 3. stupnja prijavljene su u 1,6 % bolesnika liječenih lijekom Nerlynx u odnosu na 0,5 % bolesnika koji su primali placebo, a nuspojave 4. stupnja prijavljene su u 0,2 % odnosno 0,1 % bolesnika.
Grade 3 AST increased was reported in 0.5% vs 0.3% and Grade 4 AST increased was reported in 0.2% vs 0.0%, of Nerlynx- vs placebo-treated patients.
Povišena aspartat aminotransferaza 3. stupnja prijavljena je u 0,5 % bolesnika koji su primali lijek Nerlynx u odnosu na 0,3 % bolesnika koji su primali placebo, a povišena aspartat aminotransferaza 4. stupnja prijavljena je u 0,2 % bolesnika koji su primali Nerlynx u odnosu na 0,0 % bolesnika koji su primali placebo.
- The active substance is neratinib.
- Djelatna tvar je neratinib.
9 vs. 28
9 u odnosu na
Fatigue, dizziness, dehydration, and syncope have been reported as adverse reactions with neratinib.
Kao nuspojave kod uzimanja neratiniba prijavljeni su umor, omaglica, dehidracija i sinkopa.
Treatment of patients with Child-Pugh C hepatic impairment is not recommended (see Section 5.2).
Ne preporučuje se liječenje bolesnika s teškim oštećenjem funkcije jetre (Child Pugh C)
• If grade 3 diarrhoea persists longer than 3weeks, discontinue Nerlynx permanently.
• Ako proljev 3. stupnja potraje dulje od 3 tjedna,
You need to take an anti-diarrhoea medicine when you start Nerlynx
Kada započnete liječenje lijekom Nerlynx, morate uzeti lijek protiv proljeva
Grade 3 ALT increased was reported in 1.1% vs 0.2% and Grade 4 ALT increased was reported in 0.2% vs 0.0% of Nerlynx- vs placebotreated patients.
Povišena alanin aminotransferaza 3. stupnja prijavljena je u 1,1 % bolesnika liječenih lijekom Nerlynx u odnosu na 0,2 % bolesnika koji su primali placebo, a povišena alanin aminotransferaza 4. stupnja prijavljena je u 0,2 % bolesnika liječenih lijekom Nerlynx u odnosu na 0,0 % bolesnika koji su primali placebo.
No. of Patients
Broj bolesnica
Breast-feeding
Krospovidon
Mannitol (E421) Microcrystalline cellulose Crospovidone Povidone
Jezgra tablete Manitol (E421)
Common: may affect up to 1 in 10 people - burning sensation during urination and frequent, and urgent need to urinate, (may be symptoms of urinary tract infection) - dehydration - nosebleed - mild stomach upset - dry mouth - changes in liver blood test results - nail problems including nail splitting or colour change - dry skin including cracked skin - changes in kidney function test - weight loss
- dehidracija - krvarenje iz nosa - blagi nadražaj želuca - suha usta - promjene u rezultatima krvnih pretraga jetrene funkcije
Concomitant treatment with substances that increase gastric pH should be avoided, as neratinib solubility and absorption may decrease.
Budući da može doći do smanjenja topljivosti i apsorpcije neratiniba, potrebno je izbjegavati istodobnu primjenu s tvarima koje povećavaju pH vrijednost želuca.
Proton pump inhibitors, H2-receptor antagonists and antacids Co-administration with proton pump inhibitors (PPIs) and H2-receptor antagonists are not recommended.
Inhibitori protonske pumpe, antagonisti H2 receptora i antacidi
The incidence of Grade 1 and Grade 2 was 13.3% and 2.9% respectively; 0.4% of Nerlynx-treated patients experienced Grade 3 rash.
U skupini bolesnika liječenih samo lijekom Nerlynx 16,7 % bolesnika dobilo je osip. 13,3 % bolesnika imalo je osip 1. stupnja, a njih 2,9 % osip 2. stupnja, dok je 0,4 % bolesnika liječenih lijekom Nerlynx dobilo osip 3. stupnja.
Hepatic impairment
Zatajenje bubrega
Hepatotoxicity
Kancerogeneza, mutageneza
Package leaflet: Information for the patient Nerlynx 40 mg film-coated tablets neratinib This medicine is subject to additional monitoring.
NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži neratinibmaleat u količini koja odgovara 40 mg neratiniba.
Nerlynx can cause diarrhoea early during treatment.
Kada započnete liječenje lijekom Nerlynx, morate uzeti lijek protiv proljeva Nerlynx može uzrokovati proljev u ranoj fazi liječenja.
• Grade 1 diarrhoea [increase of < 4 stools per day over baseline]
• Proljev 1. stupnja [povećanje od
CYP3A4/P-gp inhibitors
Učinci drugih tvari na neratinib Inhibitori CYP3A4/Pgp
Nerlynx dose modifications for adverse reactions
Tablica 1: Prilagodbe doze lijeka Nerlynx zbog nuspojava Razina doze
Severity of diarrhoea*
Težina proljeva*
Discontinue Nerlynx for patients who:
Potrebno je prekinuti liječenje lijekom Nerlynx u bolesnika:
Elderly
Proljev
Action
System
Very Common Muscle spasms
Mikrokristalična celuloza
Nerlynx can cause diarrhoea early during treatment unless anti-diarrhoea medicine is taken to prevent or reduce diarrhoea.
Ako ne uzmete lijek protiv proljeva radi sprječavanja ili smanjenja proljeva, Nerlynx može uzrokovati proljev u ranoj fazi liječenja.
Management of some adverse reactions may require dose interruption and/or dose reduction as shown in Table 1, Table 2, Table 3, and Table 4.
Radi zbrinjavanja nekih nuspojava možda će biti potrebno privremeno prekinuti liječenje i/ili smanjiti dozu,
This summary was last updated in August-2014.
Ovaj sažetak posljednji je put ažuriran u kolovozu-2014.
It is used in patients from 12 years of age and weighing at least 40 kg.
Koristi se u bolesnika od 12 godina pa nadalje i koji teže najmanje 40 kg.
Data from this study collected until week 96 showed that this effect was maintained over time.
Podaci iz ovog ispitivanja koji su prikupljeni do 96. tjedna pokazali su da je ovaj učinak održan s vremenom.
After 48 weeks, 88% of the patients given the combination found in Triumeq (364 out of 414) responded to treatment, compared with 81% of the patients who were given Atripla (338 out of 419).
Nakon 48 tjedana, 88% bolesnika dobilo je kombinaciju nađenu u lijeku Triumeq (364 od 414) reagiralo je na liječenje u usporedbi s 81% bolesnika koji su primili lijek Atripla (338 od 419).
Data from this study had already been used in the authorisation of Tivicay.
Podaci iz ovog ispitivanja već su korišteni u odobravanju lijeka Tivicay.
The full EPAR and risk management plan summary for Triumeq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjelovito Europsko javno izvješće o ocjeni dokumentacije (EPAR) za lijek Triumeq, kao i Plan upravljanja rizicima možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The main measure of effectiveness was the response rate, which was the proportion of patients with a reduction of the levels of virus in the blood (viral load) to fewer than 50 copies of HIV RNA per ml.
Glavna mjera djelotvornosti bila je stopa odgovora koja predstavlja udio bolesnika sa smanjenjem razine virusa u krvi (virusno opterećenje) na manje od 50 kopija HIV RNK po ml.
Before starting treatment with Triumeq, all patients should have a test to find out if they have a gene called ‘HLA-B (type 5701)'.
Prije početka liječenja lijekom Triumeq sve bolesnike treba testirati kako bi se otkrilo imaju li gen zvani "HLA-B (tip 5701)".
Other information about Triumeq
Ostale informacije o lijeku Triumeq
Triumeq reduces the amount of HIV in the blood and keeps it at a low level.
Triumeq smanjuje količinu virusa HIV-a u krvi i održava je niskom.
The CHMP concluded that the medicine had demonstrated its effectiveness in previously untreated patients, and that similar benefits are expected in patients who have received previous treatment.
CHMP je zaključio da je lijek dokazao svoju djelotvornost kod prethodno neliječenih bolesnika i da se slične koristi očekuju kod bolesnika koji su prethodno liječeni lijekom.
Why is Triumeq approved?
Zašto je Triumeq odobren?
It is not intended to provide practical advice on how to use Triumeq.
Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Triumeq.
What is Triumeq and what is it used for?
Što je Triumeq i za što se koristi?
Triumeq is available as tablets (50 mg dolutegravir / 600 mg abacavir /300 mg lamivudine) and the recommended dose is one tablet a day, taken with or without food.
Triumeq je dostupan u obliku tableta (50 mg dolutegravira/600 mg abakavira/300 mg lamivudina), a preporučena doza je jedna tableta dnevno s hranom ili bez nje.
All three active substances in Triumeq are already available in the European Union (EU) as singlecomponent medicines: abacavir has been authorised as Ziagen since 1999, lamivudine as Epivir since 1996, and dolutegravir as Tivicay since January 2014.
Sve tri djelatne tvari u lijeku Triumeq već su dostupne u Europskoj uniji (EU) kao monokomponentni lijekovi: abakavir je odobren kao Ziagen od 1999. godine, lamivudin kao Epivir od 1996. godine, a dolutegravir kao Tivicay od siječnja 2014.
Triumeq dolutegravir / abacavir / lamivudine
Triumeq dolutegravir / abakavir / lamivudin
Triumeq does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Triumeq ne liječi infekciju HIV-om niti AIDS, ali može usporiti oštećenje imunološkog sustava i razvoj infekcija i bolesti povezanih s AIDSom.
The European Commission granted a marketing authorisation valid throughout the European Union for Triumeq on 1 September 2014.
Europska komisija izdaje odobrenje za stavljanje u promet koje za lijek Triumeq vrijedi na prostoru Europske unije od 1. rujna 2014.
The combination of dolutegravir, abacavir and lamivudine (as found in Triumeq) was evaluated in one main study involving 833 previously untreated patients.
Kombinacija dolutegravira, abakavira i lamivudina (kako je otkriveno u lijeku Triumeq) procijenjena je u jednom glavnom ispitivanju koje je uključivalo 833 prethodno neliječena bolesnika.
This is a summary of the European public assessment report (EPAR) for Triumeq.
Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Triumeq.
Patients with this gene are at an increased risk of having an allergic reaction to abacavir, so they should not take Triumeq.
Bolesnici s ovim genom pod povećanim su rizikom od alergijske reakcije na abakavir tako da ne smiju uzimati Triumeq.
What measures are being taken to ensure the safe and effective use of Triumeq?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Triumeq?
The CHMP also considered the fact that Triumeq can be taken with or without food as an additional advantage compared with other similar medicines which have to be taken strictly either with food or on an empty stomach.
CHMP je također uzeo u obzir činjenicu da se Triumeq može uzimati s hranom ili bez nje kao dodatnu prednost u usporedbi s drugim sličnim lijekovima koje treba uzimati strogo s hranom ili natašte.
The combination of abacavir and lamivudine has been authorised as Kivexa since 2004.
Kombinacija abakavira i lamivudina odobrena je kao lijek Kivexa od 2004.
The most common side effects with Triumeq (which may affect more than 1 in 10 people) are insomnia (difficulty sleeping), headache, nausea (feeling sick), diarrhoea and fatigue (tiredness).
Najčešće nuspojave s lijekom Triumeq (koje mogu zahvatiti više od 1 na 10 osoba) su nesanica (poteškoće sa spavanjem), glavobolja, mučnina, proljev i umor (zamor).
They both work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Obje djeluju na isti način blokirajući aktivnost reverzne transkriptaze, enzima koji proizvodi HIV i koji omogućava virusu da zarazi stanice i da se replicira.
Giving the combined medicine rather than the single medicines reduces the number of tablets patients have to take, helping them to adhere to their treatment.
S obzirom da kombinirani lijek smanjuje broj tableta koje bolesnik mora uzeti radije nego pojedinačni lijek, to pomaže bolesniku da se pridržava liječenja.
The CHMP also noted that giving the combination of dolutegravir, abacavir and lamivudine as a single tablet is an additional treatment option for patients with HIV infection and without the HLA-B (type 5701) gene.
CHMP je također zabilježio da primjena kombinacije dolutegravira, abakavira i lamivudina kao pojedinačnih tableta u jednoj tableti može pružiti dodatnu opciju liječenja za bolesnike s HIV infekcijom i bez gena HLA-B (tip 5701).
This is an antiviral medicine that blocks an enzyme called integrase that is needed by the HIV virus to make new copies of itself in the body.
To je antivirusni lijek koji blokira enzim zvan integraza koja je potrebna kako bi se virus HIV-a kopirao u nove kopije u tijelu.