natgillin/translations-raw huggingface dataset:
Prior non-responder patients (including partial and null responders)
Bolesnici koji prethodno nisu imali odgovor (uključujući bolesnike koji su djelomično odgovorili ili s ili bez ciroze, s ili bez
Treatment with OLYSIO must be initiated in combination with peginterferon alfa + ribavirin and administered for 12 weeks and then followed by an additional 12 weeks of peginterferon alfa + ribavirin.
Liječenje lijekom OLYSIO mora se započeti u kombinaciji s peginterferonom alfa + ribavirinom i primijeniti tijekom 12 tjedana nakon čega slijedi dodatnih 12 tjedana peginterferona alfa + ribavirina.
Table 15: Treatment outcome in HCV genotype 1 infected patients with cirrhosis receiving 12 or 24 weeks simeprevir + sofosbuvir, with or without ribavirin
Tablica 15: Ishod liječenja u bolesnika inficirnaih HCV genotipom 1 s cirozom koji su primali 12 ili 24 tjedna simeprevir + sofosbuvir, s ili bez ribavirina (ispitivanje HPC2002) 24 tjedna simeprevir + sofosbuvir
Increased simeprevir exposures have been observed in individuals with severe renal impairment.
U pojedinaca s teškim oštećenjem bubrega bila je uočena povišena izloženost simepreviru.
Median baseline HCV RNA levels (log10 IU/ml) Presence of cirrhosis no cirrhosis with cirrhosis Prior treatment history treatment-naïve treatment-experienced IL28B genotype CC non-CC HCV geno/subtype and presence of baseline Q80K polymorphism in HCV genotype 1a
BMI ≥ 30 kg/m Početne razine HCV RNA > 800,000 IU/ml METAVIR skor za fibrozu F0-2 F3 F4 IL28B genotip CC CT TT HCV geno/podtip i prisutnost početnog Q80K polimorfizma u HCV genotipu 1a
Erythromycin 500 mg three times a day erythromycin AUC 1.90 (1.53-2.36) ↑ erythromycin Cmax 1.59 (1.23-2.05) ↑ erythromycin Cmin 3.08 (2.54-3.73) ↑ simeprevir AUC 7.47 (6.41-8.70) ↑ simeprevir Cmax 4.53 (3.91-5.25) ↑ simeprevir Cmin 12.74 (10.19-15.93) ↑
eritromicin AUC 1,90 (1,53-2,36)  eritromicin Cmax 1,59 (1,23-2,05)  eritromicin Cmin 3,08 (2,54-3,73)  simeprevir AUC 7,47 (6,41-8,70)  simeprevir Cmax 4,53 (3,91-5,25)  simeprevir Cmin 12,74 (10,19-15,93) 
Each capsule contains simeprevir sodium equivalent to 150 milligrams of simeprevir.
Jedna kapsula sadrži simeprevirnatrij što odgovara 150 miligrama simeprevira.
Table 18: Studies conducted with simeprevir + peginterferon alfa + ribavirin: demographics
Table 18: Ispitivanja provedena sa simeprevirom + peginterferonom alfa + ribavirinom: demografske i početne karakteristike HPC3007
Treatment-naïve and prior relapse patients
Bolesnici s prethodnim relapsom
Simeprevir in combination with peginterferon alfa and ribavirin There were no differences in haemoglobin, neutrophils or platelets between both treatment groups.
Među obje liječene skupine nije bilo razlika u hemoglobinu, neutrofilima ili trombocitima.
Table 17: Studies conducted with simeprevir + peginterferon alfa + ribavirin: population and
Tablica 17: Ispitivanja provedena sa simeprevirom + peginterferonom alfa + ribavirinom: populacija i sažetak dizajna ispitivanja uključenih bolesnika
Treatment with OLYSIO must be initiated in combination with peginterferon alfa + ribavirin and administered for 12 weeks and then followed by an additional 36 weeks of peginterferon alfa and + ribavirin.
Liječenje lijekom OLYSIO mora se započeti u kombinaciji s peginterferonom alfa + ribavirinom i primijeniti tijekom 12 tjedana nakon čega slijedi dodatnih 36 tjedana peginterferona alfa i + ribavirina.
Daclatasvir 60 mg once daily daclatasvir AUC 1.96 (1.84-2.10) ↑ daclatasvir Cmax 1.50 (1.39-1.62) ↑ daclatasvir Cmin 2.68 (2.42-2.98) ↑ simeprevir AUC 1.44 (1.32-1.56) ↑ simeprevir Cmax 1.39 (1.27-1.52) ↑ simeprevir Cmin 1.49 (1.33-1.67) ↑
Daklatasvir daklatasvir AUC 1,96 (1,84-2,10)  daklatasvir Cmax 1,50 (1,39-1,62)  daklatasvir Cmin 2,68 (2,42-2,98)  simeprevir AUC 1,44 (1,32-1,56)  simeprevir Cmax 1,39 (1,27-1,52)  simeprevir Cmin 1,49 (1,33-1,67) 
Table 14: Treatment outcome in HCV genotype 1 infected patients without cirrhosis receiving 12 weeks simeprevir + sofosbuvir, with or without ribavirin simeprevir + sofosbuvir + ribavirin N = 43 % (n/N)
Tablica 14: Ishod liječenja u bolesnika inficiranih HCV genotipom 1 bez ciroze koji su primali 12 tjedana simeprevir + sofosbuvir, s ili bez ribavirina (ispitivanje HPC2002)
Table 9: Antiviral activity of simeprevir 200 mg monotherapy (studies C201 and C202) Mean (SE) change in HCV RNA at day 7/8 (log10 IU/mL)
Tablica 9: Antivirusna aktivnost simeprevira od 200 mg u monoterapiji (ispitivanja C201 i
Treatment with OLYSIO must be initiated in combination with peginterferon alfa + ribavirin and administered for 12 weeks and then followed by an additional 36 weeks of peginterferon alfa + ribavirin.
Liječenje lijekom OLYSIO mora se započeti u kombinaciji s peginterferonom alfa + ribavirinom i primijeniti tijekom 12 tjedana nakon čega slijedi dodatnih 36 tjedana peginterferona alfa + ribavirina.
Mild increases in simeprevir concentrations may occur due to mild inhibition of OATP1B1 by sildenafil.
Mogu se javiti blaga povišenja koncentracija simeprevira zbog blage inhibicije OATP1B1
It is not recommended to co-administer OLYSIO with these anticonvulsants as co-administration may result in loss of therapeutic effect of OLYSIO.
Ne preporučuje se istovremeno primjenjivati lijek OLYSIO s ovim antikonvulzivima jer istovremena primjena može dovesti do gubitka terapijskog učinka lijeka OLYSIO.
Increased plasma concentrations of pitavastatin and pravastatin are expected.
Očekuju se povišene koncentracije pitavastatina i pravastatina u
DXM Cmin not studied dextrorphan AUC 1.09 (1.03-1.15) ↔ dextrorphan Cmax 1.03 (0.93-1.15) ↔ dextrorphan Cmin not studied
DXM AUC 1,08 (0,87-1,35) ↑ DXM Cmax 1,21 (0,93-1,57) ↑ DXM Cmin nije ispitano dekstrorfan AUC 1,09 (1,03-1,15) ↔ dekstrorfan Cmax 1,03 (0,93-1,15) ↔
Viral relapse rates are calculated with a denominator of patients with undetectable HCV RNA at actual EOT.
Stope virološkog relapsa izračunate su s nazivnikom koji predstavlja broj bolesnika s nedetektabilnom HCV RNK pri stvarnom kraju liječenja.
Discontinue peginterferon alfa and ribavirin
Prekinuti liječenje peginterferonom alfa i ribavirinom
Discontinue OLYSIO, peginterferon alfa and ribavirin
OLYSIO u kombinaciji s peginterferonom alfa i ribavrinom
Simeprevir in combination with peginterferon alfa and ribavirin: During the 12 weeks treatment with simeprevir, photosensitivity reactions were reported in 4.7% of simeprevir-treated patients compared to 0.8% in placebo-treated patients (all grades; pooled phase 3).
Simeprevir u kombinaciji s peginterferonom alfa i ribavirinom:Tijekom 12 tjedana liječenja simeprevirom, reakcije fotoosjetljivosti bile su prijavljene u 4,7% bolesnika liječenih simeprevirom u usporedbi s 0,8% bolesnika liječenih placebom (svi stupnjevi; objedinjeno za fazu 3).
≥ 1.1 to ≤ 1.5 x ULN 34 (11.9%)
≥ 1,1 do ≤ 1,5 x GGN 13 (4,5%) > 1,5 do ≤ 3,0 x GGN 22 (7,7%)
It is not recommended to co-administer OLYSIO with rifabutin or rifapentine as co-administration may result in loss of therapeutic effect of OLYSIO.
Ne preporučuje se istovremeno primjenjivati OLYSIO s rifabutinom ili rifapentinom jer istovremena primjena može dovesti do gubitka terapijskog učinka lijeka OLYSIO.
Table 20 shows the response rates in treatment-experienced patients with HCV genotype 1 infection.
Tablica 20 prikazuje stope odgovora u bolesnika s infekcijom HCV genotipom 1 koji su prethodno bili liječeni.
It is not recommended to co-administer OLYSIO with ciclosporin.
Ne preporučuje se istodobna primjena lijeka OLYSIO s ciklosporinom.
(intestinal CYP3A4 enzyme and P-gp transporter inhibition)
(inhibicija intestinalnog enzima CYP3A4 i P-gp
Antiretroviral - protease inhibitors (PIs)
Antiretrovirusni - inhibitori integraze Raltegravir
Simeprevir in combination with peginterferon alfa and ribavirin: During the 12 weeks treatment with simeprevir, ‘blood bilirubin increased' was reported in 7.4% of simeprevir-treated patients, compared to 2.8% in placebo-treated patients (all grades; pooled phase 3).
Simeprevir u kombinaciji s peginterferonom alfa i ribavirinom: Tijekom 12 tjedna liječenja simeprevirom, ‘povišen bilirubin u krvi' bio je prijavljen u 7,4% bolesnika liječenih simeprevirom u usporedbi s 2,8% bolesnika liječenih placebom (svi stupnjevi; objedinjeno za fazu 3).
SOC
K
Simeprevir in combination with peginterferon alfa and ribavirin: During the first 12 weeks treatment with simeprevir, dyspnoea was reported in 11.8% of simeprevir-treated patients, compared to 7.6% in placebo-treated patients (all grades; pooled phase 3).
Simeprevir u kombinaciji s peginterferonom alfa i ribavirinom: Tijekom prvih 12 tjedana liječenja simeprevirom, dispneja je bila prijavljena u 11,8% bolesnika liječenih simeprevirom, u usporedbi sa 7,6% bolesnika liječenih placebom (svi stupnjevi; objedinjeno za fazu 3).
Hepatic uptake of simeprevir is mediated by OATP1B1/3.
Unos simeprevira u jetru posredovan je s OATP1B1/3.
Refer to the respective Summary of Product Characteristics of the medicinal products used in combination with OLYSIO regarding their use in patients with renal impairment.
Pogledajte odgovarajući sažetak opisa svojstava lijeka za lijekove koji se uzimaju u kombinaciji sa simeprevirom vezano uz njihovu primjenu u bolesnika s oštećenjem jetre.
HCV geno/subtype and presence of Q80K polymorphism in HCV genotype 1a
HCV geno/podtip i prisutnost Q80K polimorfizma u HCV genotipu 1a
Viral relapse rates are calculated with a denominator of patients with undetectable HCV RNA at actual EOT and with at least one follow-up HCV RNA assessment.
Stope virološkog relapsa izračunavaju se s nazivnikom koji predstavlja broj bolesnika s nedetektabilnom HCV RNK pri stvarnom kraju liječenja i s barem jednim praćenjem s procjenom HCV RNK.
Includes relapsers, partial and null reponders to prior treatment with interferon (pegylated or non-pegylated), with or
Uključuje bolesnike s relapsom, djelomičnim odgovorom i bez odgovora na prethodno liječenje s interferonom (pegiliranim ili nepegiliranim), s ili bez ribavirina.
Read the package leaflets for the other medicines used for treating your hepatitis C infection for side
U uputama o lijeku za druge lijekove koje koristite za liječenje infekcije hepatitisom C pročitajte o nuspojavama prijavljenim s tim lijekovima.
24 weeks OLYSIO + sofosbuvir or 12 weeks OLYSIO + sofosbuvir + ribavirin
+ sofosbuvir ili 12 tjedana OLYSIO
Efficacy in treatment-experienced patients with HCV genotype 1 infection In study HPC3007 (PROMISE), patients who relapsed after prior IFN-based therapy received simeprevir (150 mg once daily) + peginterferon alfa-2a + ribavirin for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa-2a + ribavirin (see tables 17 and 18).
Djelotvornost u bolesnika s infekcijom HCV genotipom 1 koji su prethodno bili liječeni U ispitivanju HPC3007 (PROMISE), bolesnici koji su doživjeli relaps nakon prethodne terapije temeljene na IFN primali su simeprevir (150 mg jedanput dnevno) + peginterferon alfa-2a + ribavirin tijekom 12 tjedana, nakon čega je slijedilo 12 ili 36 dodatna tjedna peginterferona alfa-2a + ribavirina
It is not recommended to co-administer OLYSIO with efavirenz as co-administration may result in loss of therapeutic effect of OLYSIO.
Ne preporučuje se istovremeno primjenjivati OLYSIO s efavirenzom jer istovremena primjena može dovesti do gubitka terapijskog učinka lijeka OLYSIO.
Increased plasma concentrations of lovastatin are expected.
Očekuju se povišene koncentracije lovastatina u plazmi.
Efficacy in treatment-naïve patients with HCV genotype 1 infection In studies C208 (QUEST-1) and C216 (QUEST-2), treatment-naïve patients received simeprevir (150 mg once daily) + peginterferon alfa + ribavirin for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa + ribavirin (see tables 17 and 18).
U ispitivanjima C208 (QUEST-1) i C216 (QUEST-2), bolesnici koji prethodno nisu bili liječeni primali su simeprevir (150 mg jedanput dnevno) + peginterferon alfa + ribavirin tijekom 12 tjedana, nako čega je slijedilo dodatnih 12 ili 36 tjedana peginterferona alfa + ribavirina (vidjeti tablice 17 i 18).
It is not recommended to co-administer OLYSIO with systemic dexamethasone as co-administration may result in loss of therapeutic effect of OLYSIO.
Ne preporučuje se istovremeno primjenjivati OLYSIO sa sistemskim deksametazonom jer istovremena primjena može dovesti do gubitka terapijskog učinka lijeka OLYSIO.
It is not recommended to co-administer OLYSIO with rifampicin as co-administration may result in loss of therapeutic effect of OLYSIO.
Ne preporučuje se istovremeno primjenjivati OLYSIO s rifampicinom jer istovremena primjena može dovesti do gubitka terapijskog učinka lijeka OLYSIO.
25-desacetyl-rifampicin AUC 1.24 (1.13-1.36) ↑ 25-desacetyl-rifampicin Cmax 1.08 (0.98-1.19) ↔
rifampicin AUC 1,00 (0,93-1,08) ↔ rifampicin Cmax 0,92 (0,80-1,07) ↔
Efficacy in patients with HCV genotype 4 infection In study HPC3011 (RESTORE), patients who were treatment-naïve or failed prior peg-IFN/RBV therapy received simeprevir (150 mg once daily) + peginterferon alfa-2a + ribavirin for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa-2a + ribavirin (see tables 17 and 18).
U ispitivanju HPC3011 (RESTORE), bolesnici koji prethodno nisu bili liječeni ili su doživjeli neuspjeh prethodne terapije s peg-IFN/RBV primali su simeprevir (150 mg jedanput dnevno) + peginterferon alfa-2a + ribavirin tijekom 12 tjedana, nakon čega je slijedilo 12 ili 36 dodatnih tjedana peginterferona alfa-2a + ribavirin (vidjeti tablice 17 i 18).
Significantly decreased plasma concentrations of simeprevir are expected.
Očekuju se značajno snižene koncentracije simeprevira u plazmi.
Significant decrease in plasma concentrations of simeprevir are expected.
Očekuju se značajna sniženja koncentracije simeprevira u plazmi.
Ledipasvir 90 mg once daily ledipasvir AUC 1.75 (1.56-1.96) ↑ ledipasvir Cmax 1.64 (1.45-1.86) ↑ ledipasvir Cmin 1.74 (1.55-1.97) ↑
ledipasvir AUC 1,75 (1,56-1,96) ↑ ledipasvir Cmax 1,64 (1,45-1,86) ↑ ledipasvir Cmin 1,74 (1,55-1,97) ↑ simeprevir AUC 3,05 (2,43-3,84) ↑ simeprevir Cmax 2,34 (1,95-2,81) ↑ simeprevir Cmin 4,69 (3,40-6,47) ↑
Includes relapsers, partial and null responders to prior treatment with peginterferon and ribavirin.
Uključuje bolesnike s relapsom, djelomičnim odgovorom ili bez odgovora na prethodno liječenje s peginterferonom i
Efficacy in patients with HCV genotype 1 and HIV-1 co-infection In study C212, patients with HIV-1 co-infection who were treatment-naïve or failed prior peg-IFN/RBV therapy received simeprevir (150 mg once daily) + peginterferon alfa-2a + ribavirin for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa-2a + ribavirin (see tables 17 and 18).
U ispitivanju C212, bolesnici s koinfekcijom HIVom-1 koji prethodno nisu bili liječeni ili su doživjeli neuspjeh prethodne terapije s peg-IFN/RBV, primali su simeprevir (150 mg jedanput dnevno) + peginterferon alfa-2a + ribavirin tijekom 12 tjedana, nakon čega je slijedilo 12 ili 36 dodatnih tjedana peginterferona alfa-2a + ribavirin (vidjeti tablice 17 i 18).
Viral relapse rates are calculated with a denominator of patients with undetectable (or unconfirmed detectable)
Stope virološkog relapsa izračunate su uz nazivnik koji predstavlja broj bolesnika s nedetektabilnom (ili nepotvrđenom detektabilnom) HCV RNK pri stvarnom kraju liječenja.
It is not recommended to co-administer OLYSIO with milk thistle.
Ne preporučuje se istovremeno primjenjivati OLYISO sa sikavicom.
Mild
Dojenje
Significantly increased plasma concentrations of simeprevir are expected.
Očekuju se značajno povišene koncentracije simeprevira u plazmi.
(intestinal CYP3A4 enzyme inhibition)
(inhibicija intestinalnog enzima CYP3A4)
Viral relapse rates are calculated with a denominator of patients with undetectable HCV RNA at EOT and with at least one follow-up HCV RNA assessment.
Stope virološkog relapsa izračunate su s nazivnikom koji predstavlja broj bolesnika s nedetektabilnom HCV RNA na završetku liječenja i s najmanje jednom procjenom HCV RNA praćenja.
2-OH-atorvastatin AUC 2.29 (2.08-2.52) ↑ 2-OH-atorvastatin Cmax 1.98 (1.70-2.31) ↑
Atorvastatin 40 mg atorvastatin AUC 2,12 (1,72-2,62)  atorvastatin Cmax 1,70 (1,42-2,04)  atorvastatin Cmin nije ispitano 2-OH-atorvastatin AUC 2,29 (2,08-2,52)  2-OH-atorvastatin Cmax 1,98 (1,70-2,31)  2-OH-atorvastatin Cmin nije ispitano
The response rates for patients with cirrhosis (METAVIR score F4) receiving 12 or 24 weeks of simeprevir
Stope odgovora za bolesnike s cirozom (METAVIR skor F4) koji su primali 12 ili 24 tjedna simeprevir + sofosbuvir su prikazani u tablici 15.
CALCIUM CHANNEL BLOCKERS (oral administration) Amlodipine
Dekstrometorfan (DXM)
Titrate the rosuvastatin dose carefully and use the lowest necessary dose while monitoring for safety when co-administered with OLYSIO.
Pažljivo titrirajte dozu rosuvastatina i primjenjujte najnižu potrebnu dozu, uz praćenje sigurnosti pri istovremenoj primjeni s lijekom OLYSIO.
(CYP3A4 enzyme induction)
(indukcija enzima CYP3A4)
Titrate the pitavastatin and pravastatin dose carefully and use the lowest necessary dose while monitoring for safety when co-administered with OLYSIO.
Pažljivo titrirajte dozu pitavastatina i pravastatina i primjenjujte najnižu potrebnu dozu, uz praćenje sigurnosti pri istovremenoj primjeni s lijekom OLYSIO.
Titrate the simvastatin dose carefully and use the lowest necessary dose while monitoring for safety when co-administered with OLYSIO.
Pažljivo titrirajte dozu simvastatina i primjenjujte najnižu potrebnu dozu, uz praćenje sigurnosti pri istovremenoj primjeni s lijekom OLYSIO.
(strong CYP3A4 enzyme inhibition)
(snažna inhibicija enzima CYP3A4)
In HCV genotype 1a infected patients with cirrhosis, testing for the presence of the NS3 Q80K polymorphism may be considered prior to initiation of therapy with OLYSIO in combination with
Prije početka liječenja lijekom OLYSIO u kombinaciji sa sofosbuvirom u bolesnika s infekcijom HCV genotipa 1a s cirozom može se uzeti u obzir ispitivanje na prisutnost NS3 Q80K polimorfizma (vidjeti
Treatment discontinuation in patients with inadequate on-treatment virologic response
Bolesnici bez prethodnog odgovora Virološki relaps Bolesnici s prethodnim relapsom
Significant increases in plasma concentrations of simeprevir are expected.
Očekuju se značajna povišenja koncentracije simeprevira u plazmi.
(mild to moderate CYP3A4 enzyme inhibition)
(blaga do umjerena inhibicija enzima CYP3A4)
(mild intestinal CYP3A4 enzyme inhibition)
(blaga inhibicija intestinalnog enzima CYP3A4)
Nisoldipine
Rifabutin Rifapentin
Disopyramide
Amiodaron
Consult the Summary of Product Characteristics of the co-prescribed medicinal products before starting therapy with OLYSIO.
Prije početka liječenja lijekom OLYSIO pogledajte sažetke opisa svojstava lijeka za istodobno propisane lijekove.
Rilpivirine 25 mg once daily rilpivirine AUC 1.12 (1.05-1.19) ↔ rilpivirine Cmax 1.04 (0.95-1.13) ↔
rilpivirin AUC 1,12 (1,05-1,19) ↔ rilpivirin Cmax 1,04 (0,95-1,13) ↔ rilpivirin Cmin 1,25 (1,16-1,35)  simeprevir AUC 1,06 (0,94-1,19) ↔ simeprevir Cmax 1,10 (0,97-1,26)  simeprevir Cmin 0,96 (0,83-1,11) ↔
Antiviral activity in vitro
Virološki relaps
Šmartinska cesta 53
Johnson & Johnson d.o.o. Šmartinska cesta 53
Table 19 shows the response rates in HCV genotype 1 infected treatment-naïve patients.
Tablica 19 pokazuje stope odgovora u bolesnika inficiranih HCV genotipom 1 koji prethodno nisu bili
EXP
CT
simeprevir Cmin 0.86 (0.75-0.98) ↓
simeprevir AUC 0,94 (0,67-1,33) ↔ simeprevir Cmax 0,96 (0,71-1,30) ↔
Increased concentrations of
Očekuju se snižene koncentracije
Titrate the atorvastatin dose carefully and use the lowest necessary dose while monitoring for safety when co-administered with OLYSIO.
Pažljivo titrirajte dozu atorvastatina i primjenjujte najnižu potrebnu dozu, uz praćenje sigurnosti pri istovremenoj primjeni s lijekom OLYSIO.
Titrate the lovastatin dose carefully and use the lowest necessary dose while monitoring for safety when co-administered with OLYSIO.
Pažljivo titrirajte dozu lovastatina i primjenjujte najnižu potrebnu dozu, uz praćenje sigurnosti pri istovremenoj primjeni s lijekom OLYSIO.
(CYP3A4 enzyme induction or inhibition)
(indukcija ili inhibicija enzima CYP3A4)
Cobicistat-containing medicinal products
Lijekovi za liječenje infekcija mikobakterijama
HORMONAL CONTRACEPTIVES Ethinylestradiol and norethindrone
ANTIHISTAMINICI Astemizol
Clarithromycin
Buprenorfin Nalokson
OTHER SPECIAL WARNING IF NECESSARY
DRUGO POSEBNO UPOZORENJE, AKO JE POTREBNO
The following information is intended for medical or healthcare professionals only:
Sljedeće informacije namijenjene su samo liječnicima ili zdravstvenim radnicima:
if you have recently received or are about to receive a vaccine against yellow fever.
- ako ste nedavno primili ili ćete uskoro primiti cjepivo protiv žute groznice.
Further dilution is required.
Potrebno je dodatno razrjeđivanje.
In the absence of other compatibility studies this medicinal product must not be mixed with other medicinal products.
Zbog nedostatka drugih ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima.
Sienkiewicza 25, Kutno, 99-300, Poland
Sienkiewicza 25, Kutno, 99-300, Poljska ili
Treatment may be delayed to allow sufficient time for recovery.
Liječenje se može odgoditi kako bi se bolesniku omogućilo dovoljno vremena za oporavak.
If you are pregnant, , think you may be pregnant or are planning to have a baby, tell your doctor.
Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 July 2016
Datum prvog odobrenja: 22. srpanj 2016.
Infection (sepsis) may be severe and could lead to death.
Infekcija (sepsa) može biti teška i potencijalno smrtonosna.
Any diarrhoea requiring hospitalisation (irrespective of grade) or grade 3 or 4 diarrhoea.
Svaki proljev koji zahtijeva hospitalizaciju (bez obzira na stupanj) ili proljev stupnja 3 ili 4.
Contraceptive measures or abstinence are recommended.
Preporučuje se primjena kontraceptivnih mjera ili apstinencija.
The risk is increased in subjects who are already immunosuppressed by their underlying disease.
Rizik je veći u osoba koje su već imunokompromitirane zbog podležeće bolesti.
In clinical studies, there has been no indication that patients 65 years of age or older are at increased risk of adverse events compared to patients younger than 65 years old.
U kliničkim ispitivanjima nije bilo naznaka da bolesnici u dobi od 65 ili više godina imaju veći rizik štetnih događaja u usporedbi s bolesnicima mlađima od 65 godina.
Gently swirl each vial until the powder is completely dissolved.
Svaku bočicu pažljivo vrtite dok se prašak u potpunosti ne otopi.
Rare (may affect up to 1 in 1,000 people)
Rijetke: (mogu se javiti u do 1 na 1000 osoba)
Pack of 1 vial.
Pakiranje s 1 bočicom.
Kaplan Meier plots of overall survival by histology
Kaplan Meierove krivulje ukupnog preživljenja prema histologiji
Caution should be made when these medicinal product are combined with pemetrexed.
Potreban je oprez kada se ti lijekovi kombiniraju s pemetreksedom.
ITT population (N = 1725)
ITT populacija (n = 1725)
Based on the planned date of your infusion of Pemetrexed Fresenius Kabi and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them.
Ovisno o planiranom datumu primjene infuzije lijeka Pemetrexed Fresenius Kabi i/ili statusu Vaše funkcije bubrega, liječnik Vam mora reći koje lijekove možete uzimati i kada ih možete uzimati.
Frequency estimate: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000) and not known (cannot be estimated from available data).
Procjena učestalosti: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
Each pack consists of one vial.
Svako pakiranje sadrži jednu bočicu.
Pregnant women must avoid contact with cytostatic medicinal product.
Trudnice moraju izbjegavati kontakt s citostaticima.