natgillin/translations-raw huggingface dataset:
There were no new safety issues identified in patients with end stage renal disease on chronic haemodialysis receiving emtricitabine + tenofovir alafenamide, given with elvitegravir + cobicistat as a fixed-dose combination tablet (see section 5.2).
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 (vidjeti dio 5.2).
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 (M, N, O), including subtypes A, B, C, D, E, F, and G (EC50 values ranged from 0.10 to 12.0 nM) and showed activity against HIV-2 (EC50 values ranged from 0.91 to 2.63 nM).
Tenofoviralafenamid je pokazao antivirusnu aktivnost u staničnoj kulturi protiv svih skupina virusa HIV-1 (M, N i O), uključujući podtipove A, B, C, D, E, F i G (vrijednosti EC50 bile su u rasponu od 0,10 do 12,0 nM) i aktivnost na sojeve HIV-2 (vrijednosti EC50 bile su u rasponu od 0,91 do 2,63 nM).
Each Odefsey tablet contains 200 mg of emtricitabine, rilpivirine hydrochloride equivalent to 25 mg of rilpivirine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
Jedna Odefsey tableta sadrži 200 mg emtricitabina, rilpivirinklorid što odgovara 25 mg rilpivirina i tenofoviralafenamidfumarat što odgovara 25 mg tenofoviralafenamida.
In studies in treatment-naïve patients receiving emtricitabine + tenofovir alafenamide (FTC + TAF) or emtricitabine + tenofovir disoproxil fumarate (FTC + TDF), both given with elvitegravir + cobicistat as a fixed-dose combination tablet, increases from baseline were observed in both treatment groups for the fasting lipid parameters total cholesterol, direct low-density lipoprotein (LDL)- and high-density lipoprotein (HDL)-cholesterol, and triglycerides at Week 144.
(FTC + TDF), pri čemu su oba lijeka davana s elvitegravirom + kobicistatom u obliku tablete s fiksnom kombinacijom, u obje liječene skupine uočio porast u odnosu na početne vrijednosti lipida natašte, i to za ukupni kolesterol, lipoproteine niske gustoće (LDL) i lipoproteine visoke gustoće (HDL) te trigliceride, u 144. tjednu.
FTC/RPV /TDF
RPV + FTC/TDF
Cortisol
Kortizol
Rifabutin (300 mg once daily)/ Rilpivirine1
Rifabutin (300 mg jedanput na dan)/rilpivirin1
c n = 539 (TAF) or 841 (TFV) adults (GS-US-292-0111 and GS-US-292-0104, population PK analysis).
a n = 24 adolescenta (GS-US-292-0106); n = 19 odraslih (GS-US-292-0102) b n = 23 adolescenta (GS-US-292-0106, populacijska farmakokinetička analiza) c n = 539 (TAF) ili 841 (TFV) odraslih (GS-US-292-0111 i GS-US-292-0104, populacijska farmakokinetička analiza)
Nervous system disorders Very common:
Poremećaji živčanog sustava
The mean baseline CD4+ cell count was 700 cells/mm3 (range 140-1,862).
Srednja vrijednost početnog broja CD4+ stanica iznosila je 700 stanica/mm3 (raspon 140−1862).
tenofovir alafenamide tenofovir disoproxil lamivudine adefovir dipivoxil
tenofoviralafenamid tenofovirdizoproksil lamivudin adefovirdipivoksil
Patients had a mean age of 45 years (range 23-72), 90% were male, 75% were White, and 19% were Black.
Srednja vrijednost dobi bolesnika bila je 45 godina (raspon 23−72), 90% su bili muškarci, 75% bijelci i 19% crnci.
6 Adverse reaction identified through post-marketing surveillance for tenofovir alafenamide-containing products.
6 Nuspojava prepoznata tijekom praćenja lijekova koji sadrže tenofoviralafenamid nakon njihova stavljanja u promet.
0.7% (95% CI: -4.3% to 5.8%)
0,7% (95% CI: -4,3% do 5,8%)
ANTICONVULSANTS Carbamazepine Oxcarbazepine Phenobarbital Phenytoin
Karbamazepin Okskarbazepin Fenobarbital
The safety of emtricitabine + tenofovir alafenamide was evaluated through 48 weeks in an open-label clinical study (GS-US-292-0106) in which 50 HIV-1 infected, treatment-naïve paediatric patients aged 12 to < 18 years received emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet.
Sigurnost emtricitabina + tenofoviralafenamida procijenjena je tijekom 48 tjedana otvorenog kliničkog Ispitivanja (GS-US-292-0106) u kojem je 50 pedijatrijskih bolesnika u dobi od 12 do < 18 godina zaraženih virusom HIV-1 koji prethodno nisu bili liječeni, primalo emtricitabin + tenofoviralafenamid u kombinaciji s elvitegravirom i kobicistatom u obliku tablete s fiksnom kombinacijom.
Paracetamol: AUC: ↔ Cmin: N/A
Paracetamol: AUC: ↔ Cmin: N/P Cmax: ↔
Patients had a mean age of 48 years (range 19-76), 87% were male, 67% were White, and 27% were Black.
Srednja vrijednosti dobi bolesnika bila je 48 godina (raspon 19−76), 87% su bili muškarci, 67% bijelci i 27% crnci.
2.0% (95% CI: -0.7% to 4.7%) 4.2% (95% CI: 0.6% to 7.8%) 4.1% (95% CI: 1.6% to 6.7%, p < 0.001c)
4,1% (95% CI: 1,6% do 6,7%; p < 0,001c)
had emerging resistance-associated substitutions and/or phenotypic resistance to rilpivirine (7/288) than patients with baseline viral load > 100,000 copies/mL (30/262).
Tijekom 96. tjedna je manje bolesnika u skupini koja uzima rilpivirin s početnim virusnim opterećenjem ≤ 100 000 kopija/ml imalo novonastale supstitucije povezane s rezistencijom i/ili fenotipsku rezistenciju na rilpivirin (7/288) nego bolesnici s početnim virusnim opterećenjem > 100 000 kopija/ml (30/262).
The safety of emtricitabine + 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 + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet.
Sigurnost emtricitabina + 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 emtricitabin + tenofoviralafenamid u kombinaciji s elvitegravirom + kobicistatom u obliku tablete s fiksnom kombinacijom.
Emtricitabine + tenofovir alafenamide containing regimens Treatment-naïve and virologically suppressed HIV-1 infected adult patients In Study GS-US-292-0104 and Study GS-US-292-0111, patients received either E/C/F/TAF (n = 866) or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) (n = 867) once daily, both given as FDC tablets.
Ispitivanju GS-US-292-0104 i Ispitivanju GS-US-292-0111, bolesnici su primali ili E/C/F/TAF (n = 866) ili elvitegravir/kobicistat/emtricitabin/tenofovirdizoproksilfumarat (E/C/F/TDF) (n = 867) jedanput na dan, s tim da su obje terapije davane u obliku tableta s fiksnom kombinacijom.
Norethindrone (1 mg once daily)/ Rilpivirine
Noretindron (1 mg jedanput na dan)/rilpivirin
The mean baseline CD4+ cell count was 636 cells/mm3 (range 263-1,498).
Srednja vrijednost početnog broja stanica CD4+ bila je 636 stanica/mm3 (u rasponu od 263 do 1498).
Rifabutin (300 mg once daily)/ Rilpivirine
Rifabutin (300 mg jedanput na dan)/rilpivirin
Co-administration is likely to cause significant decreases in the plasma concentrations of tenofovir alafenamide (induction of P-gp).
Istodobna primjena će vjerojatno prouzročiti značajno smanjenje koncentracije tenofoviralafenamida u plazmi (indukcija P-gp).
A strict dosing schedule with intake of the H2-receptor antagonists at least 12 hours before or at least 4 hours after Odefsey should be used.
H2-receptora najmanje 12 sati prije ili najmanje 4 sata nakon što bi se Odefsey trebao koristiti.
(78.6%, 22/28) as compared to those with a baseline viral load > 100,000 copies/mL (50.0%, 4/8).
Udio onih koji su odgovorili bio je veći u ispitanika s početnim virusnim opterećenjem ≤ 100 000 kopija/ml (78,6%, 22/28) u usporedbi s onima kod kojih je početno virusno opterećenje > 100 000 kopija/ml (50,0%, 4/8).
In the pooled Phase 3 TMC278-C209 and TMC278-C215 studies of treatment-naïve patients, at Week 96, there was an overall mean change from baseline in basal cortisol of -19.1 (-30.85; -7.37) nmol/L in the rilpivirine arm and of -0.6 (-13.29; 12.17) nmol/L in the efavirenz arm. At Week 96, the mean change from baseline in ACTH-stimulated cortisol levels was lower in the rilpivirine arm (+18.4 ± 8.36 nmol/L) than in the efavirenz arm (+54.1 ± 7.24 nmol/L).
U objedinjenim ispitivanjima TMC278-C209 i TMC278-C215 faze 3 bolesnika koji prethodno nisu bili liječeni, u 96. tjednu, pojavila se ukupna srednja vrijednost promjene od početne vrijednosti za bazalni kortizol, i to od -19,1 (-30,85; -7,37) nmol/l u skupini liječenoj rilpivirinom i od -0,6 (-13,29; 12,17) nmol/l u skupini liječenoj efavirenzom.
No virologic data in Week 48 or 96 window
HIV-1 RNK ≥ 50 kopija/mld Bez viroloških podataka u okviru 48. ili 96. tjedna
Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 RT. Rilpivirine does not inhibit the human cellular DNA
Aktivnost rilpivirina postignuta je nekompetitivnom inhibicijom HIV-1 RT.
Virologically suppressed HIV-1 infected adult patients In Study GS-US-366-1216, the efficacy and safety of switching from FTC/RPV/TDF to Odefsey were evaluated in a randomised, double-blind study of virologically suppressed HIV-1 infected adults.
Ispitivanju GS-US-366-1216, djelotvornost i sigurnost prebacivanja s FTC/RPV/TDF na Odefsey procijenjene su u randomiziranom, dvostruko slijepom ispitivanju u odraslih bolesnika zaraženih virusom HIV-1 u kojih je virus bio suprimiran.
Famotidine (40 mg single dose taken 12 hours before rilpivirine)/ Rilpivirine1
Famotidin (jedna doza od 40 mg uzeta 12 sati prije rilpivirina)/
AUC: ↓ 80% Cmin: ↓ 89% Cmax: ↓ 69%
AUC: ↓ 80% Cmin: ↓ 89% Cmax: ↓ 69% Indukcija CYP3A
RPV + FTC/TDF (n = 550)
FTC/RPV /TDF (n = 313)c
AUC: ↓ 16% Cmin: ↓ 21% Cmax: ↓ 13%
S(+) metadon: AUC: ↓ 16% Cmin: ↓ 21% Cmax: ↓ 13%
Co-administration of ciclosporin is expected to increase plasma concentrations of rilpivirine (inhibition of CYP3A) and tenofovir alafenamide (inhibition of P-gp).
Očekuje se da će istodobna primjena ciklosporina povisiti koncentracije rilpivirina (inhibicija CYP3A) i tenofoviralafenamida (inhibicija P-gp) u plazmi.
Famotidine (40 mg single dose taken 4 hours after rilpivirine)/ Rilpivirine1
Famotidin (jedna doza od 40 mg uzeta 4 sata nakon rilpivirina)/
Co-administration may cause significant decreases in the plasma concentrations of rilpivirine (induction of CYP3A) and tenofovir alafenamide (induction of P-gp).
Istodobna primjena može prouzročiti značajna smanjenja koncentracije rilpivirina u plazmi (indukcija CYP3A) i tenofoviralafenamida (indukcija P-gp).
fatigue1, 3
osip1,3
The safety of emtricitabine + tenofovir alafenamide was evaluated through 144 weeks in an open-label clinical study (GS-US-292-0112), in which 248 HIV-1 infected patients who were either treatment-naïve (n = 6) or virologically suppressed (n = 242) with mild to moderate renal impairment (estimated glomerular filtration rate by Cockcroft-Gault method [eGFRCG]: 30-69 mL/min) received emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet.
Ispitivanja (GS-US-292-0112) u kojem je 248 bolesnika zaraženih virusom HIV-1 koji prethodno nisu bili liječeni (n = 6) ili im je virus bio suprimiran (n = 242) s blagim do umjerenim oštećenjem funkcije bubrega (procijenjena brzina glomerularne filtracije Cockcroft-Gaultovom metodom [eGFRCG]: 30-69 ml/min) dobivali su emtricitabin + tenofoviralafenamid u kombinaciji s elvitegravirom + kobicistatom u obliku tablete s fiksnom kombinacijom.
Antiviral agents Ledipasvir/Sofosbuvir (90 mg/400 mg once daily)/ Rilpivirine
Antivirusni lijekovi Ledipasvir/sofosbuvir (90 mg/400 mg jedanput na dan)/
Rilpivirine-containing regimen
Režim koji uključuje rilpivirin
Emtricitabine + tenofovir alafenamide
Odrasli Emtricitabin + tenofoviralafenamid Emtricitabin + tenofoviralafenamid FTCa
Lansoprazole Rabeprazole Pantoprazole Esomeprazole Dexlansoprazole
Pantoprazol Esomeprazol Dekslanzoprazol
Midazolam (1 mg, intravenously, single dose)/ Tenofovir alafenamide
Midazolam (1 mg intravenski,
Famotidine (40 mg single dose taken 2 hours before rilpivirine)/ Rilpivirine1
Famotidin (jedna doza od 40 mg uzeta 2 sata prije rilpivirina)/
AUC: ↑ 6% Cmin: ↓ 4% Cmax: ↑ 10%
Simeprevir: AUC: ↑ 6% Cmax: ↓ 4% Cmax: ↑ 10%
PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS Sildenafil (50 mg single dose)/ Rilpivirine1
INHIBITORI FOSFODIESTERAZE TIPA 5 (PDE-5)
AUC: ↓ 42% Cmin: ↓ 48% Cmax: ↓ 31%
AUC: ↓ 42% Cmin: ↓ 48% Cmax: ↓ 31% Indukcija CYP3A
You must remain under the care of your doctor while taking Odefsey.
Za vrijeme uzimanja lijeka Odefsey morate ostati pod nadzorom svog liječnika.
No virologic data in Week 48 or 144 window Discontinued study drug due to AE or deathe
HIV-1 RNK ≥ 50 kopija/mld Bez viroloških podataka u okviru 48. ili 144. tjedna Prekid liječenja ispitivanim lijekom zbog štetnih događaja ili smrtie Prekid liječenja ispitivanim lijekom iz drugih razloga i posljednje dostupne vrijednosti
In treatment-naïve adult patients
U odraslih bolesnika koji prethodno nisu bili liječeni
HIV-1 infected adult patients with mild to moderate renal impairment In Study GS-US-292-0112, the efficacy and safety of E/C/F/TAF FDC tablet were evaluated in an open-label clinical study of 242 HIV-1 infected, virologically suppressed patients with mild to moderate renal impairment (eGFRCG: 30-69 mL/min).
U otvorenom kliničkom Ispitivanju GS-US-292-0112 na 242 virološki suprimirana bolesnika zaražena virusom HIV-1 s blagim do umjerenim oštećenjem funkcije bubrega (eGFRCG: 30-69 ml/min) procijenjena je djelotvornost i sigurnost E/C/F/TAF tablete s fiksnom kombinacijom.
Co-administration is likely to cause significant decreases in the plasma concentrations of rilpivirine (induction of CYP3A) and tenofovir alafenamide (induction of P-gp).
Istodobna primjena će vjerojatno prouzročiti značajno smanjenje koncentracije rilpivirina (indukcija CYP3A) i tenofoviralafenamida (indukcija P-gp) u plazmi.
AUC: ↑ 49% Cmin: ↑ 76% Cmax: ↑ 30%
AUC: ↑ 49% Cmin: ↑ 76% Cmax: ↑ 30% Inhibicija CYP3A
Women of childbearing potential/contraception in males and females The use of Odefsey should be accompanied by the use of effective contraception.
Uz primjenu lijeka Odefsey mora se koristiti učinkovita kontracepcija.
-0.3% (95% CI: -4.2% to 3.7%)
2,0% (95% CI: -0,7% do 4,7%)
At Week 144, 83.1% (197/237 patients) maintained HIV-1 RNA < 50 copies/mL after switching to E/C/F/TAF FDC tablet.
Nakon prebacivanja na tabletu s fiksnom kombinacijom E/C/F/TAF, 83,1% (197/237 bolesnika) bolesnika je u 144. tjednu zadržalo HIV-1 RNK < 50 kopija/ml.
Ledipasvir/Sofosbuvir (90 mg/400 mg once daily)/ Tenofovir alafenamide
Ledipasvir/sofosbuvir (90 mg/400 mg jedanput na dan)/
PROTON PUMP INHIBITORS Omeprazole (20 mg once daily)/ Rilpivirine1
Omeprazol (20 mg jedanput na dan)/rilpivirin1
There are a limited amount of data (less than 300 pregnancy outcomes) from the use of rilpivirine and tenofovir alafenamide in pregnant women (see sections 4.4, 5.1 and 5.2).
Podaci o primjeni rilpivirina i tenofoviralafenamida u trudnica su ograničeni (manje od 300 trudnoća)
Antacids should only be administered either at least 2 hours before or at least 4 hours after Odefsey.
2 sata prije ili najmanje 4 sata nakon lijeka Odefsey.
No dose adjustment of Odefsey is required in adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis; however, Odefsey should generally be avoided but may be used with caution in these patients if the potential benefits are considered to outweigh the potential risks (see sections 4.4 and 5.2).
Međutim, iako Odefsey općenito treba izbjegavati u ovih bolesnika, može ga se primijeniti s oprezom ako se smatra da su moguće koristi veće od mogućih rizika (vidjeti dijelove 4.4 i 5.2).
AUC: ↑ 32% Cmax: ↑ 3%
Tenofoviralafenamid: AUC: ↑ 32% Cmax: ↑ 3%
immune reactivation syndrome1 Metabolism and nutrition disorders Very common:
Poremećaji metabolizma i prehrane
AUC: ↑ 5% Cmax: ↓ 4%
Sofosbuvir: AUC: ↑ 5% Cmax: ↓ 4%
The mean baseline CD4+ cell count was 697 cells/mm3 (range
Srednja vrijednost početnog broja CD4+ stanica bila je 697 stanica/mm3 (raspon 79-1951).
HMG CO-A REDUCTASE INHIBITORS Atorvastatin (40 mg once daily)/ Rilpivirine1
Atorvastatin (40 mg jedanput na dan)/rilpivirin1
0.4% (95% CI: -3.0% to 3.8%) 5.4% (95% CI: 1.5% to 9.2%)
5,4% (95% CI: 1,5% do 9,2%)
Virologically suppressed adults in Study GS-US-292-0109
GS-US-292-0109
5 Adverse reaction identified through post-marketing surveillance for emtricitabine-containing products.
Nuspojava prepoznata tijekom praćenja lijekova koji sadrže emtricitabin nakon njihova stavljanja u promet.
One patient with emergent resistance (M184M/I) was identified in a clinical study of virologically suppressed patients who switched from a regimen containing emtricitabine + tenofovir disoproxil fumarate to E/C/F/TAF in a fixed-dose combination (FDC) tablet (GS-US-292-0109, n = 959).
+ tenofovirdizoproksilfumarat na E/C/F/TAF u tableti s fiksnom kombinacijom (FDC) (GS-US-292-0109, n = 959) zabilježen je jedan bolesnik s novonastalom rezistencijom (M184M/I).
ODE
A.
(n = 313)c
(n = 959)
Omeprazole:
Očekivano:
emtricitabine, rilpivirine and tenofovir alafenamide.
emtricitabin/rilpivirin/tenofoviralafenamid
Packaging
Naziv
This effect was maintained for almost one year.
Taj učinak zadržao se gotovo godinu dana.
The recommended dose is 11 mg per kilogram body weight, and the infusion should last around one hour.
Preporučena doza je 11 mg po kilogramu tjelesne težine, a infuzija treba trajati oko jedan sat.
The Agency also acknowledged that there is an unmet medical need for these patients.
Agencija je također zaključila da u tih bolesnika postoji neispunjena medicinska potreba.
Sylvant (siltuximab)
Sylvant (siltuksimab)
Sylvant is given every three weeks, until the patient no longer benefits from treatment.
Sylvant se daje svaka tri tjedna sve dok bolesnik ne prestane imati koristi od terapije.
The most serious side effect is anaphylactic reaction (a severe allergic reaction).
Najozbiljnija nuspojava je anafilaktična reakcija (teška alergijska reakcija).
What is Sylvant and what is it used for?
Što je Sylvant i za što se koristi?
A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Monoklonsko protutijelo je vrsta proteina proizvedenog da bi prepoznalo i vezalo se na određenu strukturu u tijelu (pod nazivom antigen).
Further information on Sylvant can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Više informacija o lijeku Sylvant možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The company will ensure that healthcare professionals who are expected to use the medicine are provided with information on how to enter their patients in the registry.
Tvrtka će se pobrinuti da se zdravstvene radnike za koje se očekuje da će primjenjivati lijek obavijesti o tome kako će upisivati svoje bolesnike u registar.
Sylvant received a marketing authorisation valid throughout the EU on 22 May 2014.
Lijek Sylvant dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 22. svibnja 2014.
Siltuximab has been designed to attach to a protein in the body called interleukin 6 (IL-6).
Siltuksimab je namijenjen za vezanje na protein u tijelu pod nazivom interleukin 6 (IL-6).
It is given by infusion (drip) into a vein.
Daje se intravenskom infuzijom (drip).
Sylvant can only be obtained with a prescription and treatment should be given by qualified healthcare professionals and under appropriate medical supervision.
Sylvant se može dobiti samo na recept, a liječenje moraju provoditi za to osposobljeni zdravstveni radnici pod odgovarajućim medicinskim nadzorom.
What measures are being taken to ensure the safe and effective use of Sylvant?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Sylvant?
Other information about Sylvant
Ostale informacije o lijeku Sylvant
What are the risks associated with Sylvant?
Koji su rizici povezani s lijekom Sylvant?
The effect of the medicine was compared with placebo (a dummy treatment) and the main measure of effectiveness was the proportion of patients who responded to treatment for at least 18 weeks, as shown by a 50% reduction (‘partial response') or complete disappearance (‘complete response') of tumours and symptoms of the disease.
Učinak lijeka uspoređen je s placebom (prividno liječenje), a glavna mjera učinkovitosti bio je udio bolesnika s odgovorom na liječenje od najmanje 18 tjedana, iskazanim kao smanjenje od 50 % („djelomičan odgovor”) ili potpuni nestanak („potpuni odgovor”) tumora i simptoma bolesti.
During the first 12 months of treatment the patient should have a blood test before each dose of Sylvant, and every nine weeks afterwards; treatment may need to be delayed in patients whose blood tests are abnormal or who have certain side effects.
Tijekom prvih 12 mjeseci liječenja treba provoditi pretrage krvi bolesnika prije svake doze lijeka Sylvant, a poslije toga svakih devet tjedana; u bolesnika u kojih pretrage krvi pokažu odstupanja ili se pojave neke nuspojave, liječenje možda treba odgoditi.
The Agency concluded that Sylvant has shown beneficial effect by reducing tumour size and symptoms in patients with multicentric Castleman's disease, and that this positive effect seems to be maintained over time.
Agencija je zaključila da je lijek Sylvant pokazao povoljan učinak smanjivši veličinu tumora i simptome bolesti u bolesnika s multicentričnom Castlemanovom bolešću, te da izgleda da se taj pozitivni učinak održava.
Side effects reported with Sylvant are carefully evaluated and any necessary action taken to protect patients.
Nuspojave prijavljene za lijek Sylvant pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
Symptoms can include tiredness, sweating at night, fever, peripheral neuropathy (pins and needles due to nerve damage) and swelling of liver and spleen.
Simptomi mogu uključivati umor, noćno znojenje, vrućicu, perifernu neuropatiju (trnce zbog oštećenja živaca) i oticanje jetre i slezene.
For more information about using Sylvant, see the summary of product characteristics or contact a doctor or pharmacist.
Za više informacija o primjeni lijeka Sylvant pogledajte sažetak opisa svojstava lijeka ili se obratite liječniku ili ljekarniku.
The company that markets Sylvant is required to set up a patient registry to provide further data on long-term safety.
Tvrtka koja stavlja lijek Sylvant u promet mora uspostaviti registar bolesnika kako bi se dobili dodatni podatci o dugoročnoj sigurnosti primjene.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sylvant have also been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Sylvant nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
Why is Sylvant authorised in the EU?
Zašto je lijek Sylvant odobren u EU-u?
Side effects of Sylvant were considered acceptable but further long-term data are to be collected.
Nuspojave lijeka Sylvant smatraju se prihvatljivima, ali potrebno je i dalje prikupljati dugoročne podatke.
The most common side effects with Sylvant (which may affect more than 1 in 5 people) are infections (including upper respiratory tract infections such as those of the throat and nose), itching, rash, joint pain and diarrhoea.
Najčešće nuspojave lijeka Sylvant (koje se mogu pojaviti u više od 1 na 5 osoba) jesu infekcije (uključujući infekcije gornjih dišnih puteva kao što su infekcije grla i nosa), svrbež, osip, bol u zglobovima i proljev.