natgillin/translations-raw huggingface dataset:
GT: Genotype; CP: Child Pugh * Includes patients co-infected with human immunodeficiency virus (HIV).
GT: genotip; CP: Child-Pugh
CYP3A4 inhibition by ketoconazole
Ketokonazol inhibira CYP3A4.
Strong or moderate inducers of CYP3A4 and P-gp may decrease the plasma levels and therapeutic effect of daclatasvir.
Daklatazvir je supstrat CYP3A4, P-gp i organskog kationskog transportera (OCT) 1. Snažni ili umjereni induktori CYP3A4 i P-gp mogu smanjiti razine daklatazvira u plazmi i njegov terapijski učinak.
Inhibition of P-gp and BCRP by daclatasvir
Daklatazvir inhibira P-gp i BCRP.
Lopinavir 400 mg/ritonavir 100 mg twice daily (daclatasvir 30 mg once daily)
Očekuje se: ↔ daklatazvir lopinavir 400mg/ritonavir 100 mg dva puta na dan (daklatazvir 30 mg jedanput na dan)
CYP3A4 inhibition by telaprevir
Telaprevir inhibira CYP3A4
Daklinza 30 mg film-coated tablets
Daklinza 30 mg filmom obložene tablete
NAME OF THE MEDICINAL PRODUCT Daklinza 90 mg tablets daclatasvir
NAZIV LIJEKA Daklinza 90 mg tablete daklatazvir
NAME OF THE MEDICINAL PRODUCT Daklinza 30 mg tablets daclatasvir
NAZIV LIJEKA Daklinza 30 mg tablete daklatazvir
daclatasvir + sofosbuvir N=17
daklatazvir + sofosbuvir N=17
Rilpivirine
↔ rilpivirin
Age (years): median (range) Race: White Black/African American Other HCV genotype: 1a 1b
Rasa: bijela crna/afroamerička druga
End of treatment HCV RNA undetectable SVR12
HCV RNK nemjerljive razine SVR12
↔ Cyclosporine AUC: 1.03 (0.97, 1.09) Cmax: 0.96 (0.91, 1.02)
AUC: 1,03 (0,97; 1,09) Cmax: 0,96 (0,91; 1,02)
What Daklinza looks like and contents of the pack Daklinza 30 mg: the film-coated tablet is green, biconvex, pentagonal shape with "BMS" debossed on one side and "213" on the other side.
Daklinza 30 mg: filmom obložena tableta je zelena bikonveksna peterokutna tableta s utisnutom oznakom "BMS" na jednoj i "213" na drugoj strani.
Cirrhosis was determined by liver biopsy (METAVIR F4) for 14 patients, FibroScan >14.6 kPa for
Ciroza je bila određena biopsijom jetre (METAVIR F4) za 14 bolesnika, FibroScan >14,6 kPa za 11 bolesnika ili rezultat FibroTesta ≥0,75 te indeks omjera aspartat aminotransferaza (AST): trombociti (APRI) >2 za 7 bolesnika.
Concerning recommended regimens with different HCV genotypes, see section 4.2.
Za preporučene režime liječenja s obzirom na različite genotipove HCV-a, vidjeti dio 4.2. Za virološku i kliničku aktivnost protiv pojedinog genotipa, vidjeti dio 5.1.
Refer to the respective Summary of Product Characteristics for drug interaction information for other medicinal products in the regimen.
Za informacije o interakcijama ostalih lijekova u režimu, pročitajte Sažetke opisa svojstava tih lijekova.
daclatasvir + sofosbuvir N=21
daklatazvir + sofosbuvir N=21
Simeprevir 150 mg once daily (daclatasvir 60 mg once daily)
Preporuke za istodobnu primjenu simeprevir 150 mg jedanput na dan (daklatazvir 60 mg jedanput na dan)
The dose of Daklinza should be reduced to 30 mg once daily when coadministered with cobicistat or other strong inhibitors of CYP3A4.
Dozu lijeka daklinza potrebno je smanjiti na 30 mg jedanput na dan kada se primjenjuje istodobno s kobicistatom ili drugim snažnim inhibitorima CYP3A4.
Triazolam Alprazolam
Preporuke za istodobnu primjenu triazolam alprazolam
Table 13: Treatment outcomes, daclatasvir in combination with peginterferon alfa and ribavirin (pegIFN/RBV), treatment-naïve patients with HCV genotype 4
HCV genotipa 4. Tablica 13: Ishodi liječenja, daklatazvir u kombinaciji s peginterferonom alfa i ribavirinom
NAME OF THE MEDICINAL PRODUCT Daklinza 60 mg tablets daclatasvir
NAZIV LIJEKA Daklinza 60 mg tablete daklatazvir
Prior telaprevir or boceprevir failures daclatasvir + sofosbuvir N=70
Bolesnici koji nisu odgovorili na prethodno liječenje telaprevirom ili boceprevirom daklatazvir + sofosbuvir N=70
Ribavirin Dosing Guideline
Smjernica za doziranje ribavirina
Daklinza 60 mg film-coated tablets
Daklinza 60 mg filmom obložene tablete
↔ Ribavirin AUC: 0.94 (0.80, 1.11) Cmax: 0.94 (0.79, 1.11) Cmin: 0.98 (0.82, 1.17)
AUC: 0,94 (0,80; 1,11) Cmax: 0,94 (0,79; 1,11) Cmin: 0,98 (0,82; 1,17)
No dose adjustment of Daklinza is required.
Nije potrebno prilagođavati dozu lijeka Daklinza.
SVR rates were comparable regardless of HIV regimen, age, race, gender, IL28B allele status, or baseline HCV RNA level.
Stope SVR-a bile su usporedive neovisno o režimu liječenja HIV-a, dobi, rasi, spolu, statusu alela
↔ Daclatasvir AUC: 1.15 (1.07, 1.24) Cmax: 0.67 (0.61, 0.74)
AUC: 1,15 (1,07, 1,24) Cmax: 0,67 (0,61, 0,74)
Treatment-naïve
• ošamućenost
Increase in gastric pH
Povećanje želučanog pH.
↔ Midazolam AUC: 0.87 (0.83, 0.92) Cmax: 0.95 (0.88, 1.04)
AUC: 0,87 (0,83; 0,92) Cmax: 0,95 (0,88; 1,04)
daclatasvir + sofosbuvir N=13
daklatazvir + sofosbuvir N=13
↔ Tacrolimus AUC: 1.00 (0.88, 1.13) Cmax: 1.05 (0.90, 1.23)
AUC: 1,00 (0,88; 1,13) Cmax: 1,05 (0,90; 1,23)
daclatasvir + sofosbuvir + ribavirin N=56
daklatazvir + sofosbuvir + ribavirin N=56
Expected due to inhibition of P-gp by daclatasvir:
Budući da daklatazvir inhibira P-gp,
Skin and subcutaneous tissue disorders common rash, alopecia, pruritus, dry skin Musculoskeletal and connective tissue disorders common arthralgia, myalgia arthralgia, myalgia
Poremećaji kože i potkožnog tkiva često osip, alopecija, pruritus, suha koža
CYP3A4 inhibition by ritonavir
Ritonavir inhibira CYP3A4
Coadministration of Daklinza with St. John's wort or other strong inducers of CYP3A4 is contraindicated (see section 4.3).
Istodobna primjena lijeka Daklinza s gospinom travom ili drugim snažnim induktorima CYP3A4 je kontraindicirana (vidjeti dio 4.3).
Verapamil
daklatazvir
ANTIFUNGALS Ketoconazole 400 mg once daily (daclatasvir 10 mg single dose)
ANTIFUNGICI ketokonazol 400 mg jedanput na dan
Common (may affect up to 1 in 10 people): difficulty sleeping dizziness migraine nausea (feeling sick), diarrhoea, abdominal pain joint pain, aching or tender muscles, not caused by exercise
Često (mogu se javiti u do 1 na 10 osoba): smanjen tek tegobe sa spavanjem, razdražljivost omaglica migrena nedostatak zraka, kašalj, kongestija nosa (začepljen nos)
End of treatment HCV RNA undetectable
Nemjerljiva razina HCV RNK
Treatment-naïve N=101
Prethodno liječeni* N=51
daclatasvir + sofosbuvir + ribavirin N=20
daklatazvir + sofosbuvir + ribavirin N=20
Expected due to CYP3A4 induction by the antimycobacterial:
Budući da antimikobakterijski lijekovi induciraju CYP3A4, očekuje se:
A third treatment group in study ALLY-2 included 50 HCV treatment-naïve HIV co-infected patients who received daclatasvir and sofosbuvir for 8 weeks.
HIV-om koji prethodno nisu primali liječenje za HCV i koji su u ovom ispitivanju primali daklatazvir i sofosbuvir tijekom 8 tjedana.
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No dose adjustment of Daklinza or escitalopram is required.
Nije potrebno prilagođavati dozu lijeka Daklinza ni escitaloprama.
The Summary of Product Characteristics for the other medicinal products in the regimen should also be consulted before initiation of therapy with Daklinza.
Prije početka liječenja lijekom Daklinza, treba pročitati i Sažetke opisa svojstava drugih lijekova koji se primjenjuju u tom režimu.
IMMUNOSUPPRESSANTS Cyclosporine 400 mg single dose (daclatasvir 60 mg once daily)
ciklosporin u pojedinačnoj dozi od 400 mg (daklatazvir 60 mg jedanput na dan)
Vascular disorders common hot flush
Krvožilni poremećaji često navala vrućine
MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/001 28 tablets (calendar pack) EU/1/14/939/002 28 x 1 tablet
EU/1/14/939/001 28 tableta (kalendarski označeno pakiranje)
Tablet film-coat
Tablični prikaz nuspojava
Tacrolimus 5 mg single dose (daclatasvir 60 mg once daily)
takrolimus u pojedinačnoj dozi od 5 mg (daklatazvir 60 mg jedanput na dan)
*PK parameters for daclatasvir when administered with peginterferon alfa and ribavirin in this study were similar to those observed in a study of HCVinfected subjects administered daclatasvir monotherapy for 14 days.
*U ovom su ispitivanju farmakokinetički parametri daklatazvira pri istodobnoj primjeni s peginterferonom alfa i ribavirinom bili slični onima primijećenima u ispitivanju
BRISTOL-MYERS SQUIBB, S.A.
Bristol-Myers Squibb B.V.
daclatasvir + sofosbuvir + ribavirin N=9
daklatazvir + sofosbuvir + ribavirin N=9
daclatasvir + sofosbuvir + ribavirin N=5
daklatazvir + sofosbuvir + ribavirin N=5
No dose adjustment of Daklinza or maraviroc is required.
Nije potrebno prilagođavati dozu lijeka Daklinza ni maraviroka.
Daclatasvir in combination with peginterferon alfa and ribavirin Baseline NS5A RAVs (at M28T, Q30, L31, and Y93 for genotype 1a; at L31 and Y93 for genotype 1b) increase the risk for non-response in treatment-naive patients infected with genotype 1a and genotype 1b infection.
Početne varijante NS5A koje su povezane s rezistencijom (M28T, Q30, L31 i Y93 za genotip 1a; L31
MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/005 28 tablets (calendar pack) EU/1/14/939/006 28 x 1 tablet
EU/1/14/939/005 28 tableta (kalendarski označeno pakiranje)
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg of daclatasvir (as dihydrochloride).
Jedna filmom obložena tableta sadrži 30 mg daklatazvira (u obliku daklatazavir diklorida).
Respiratory, thoracic and mediastinal disorders common dyspnoea, dyspnoea exertional, cough, nasal congestion
Poremećaji dišnog sustava, prsišta i sredoprsja često dispneja, dispneja u naporu, kašalj, kongestija nosa
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 90 mg of daclatasvir (as dihydrochloride).
Jedna filmom obložena tableta sadrži 90 mg daklatazvira (u obliku daklatazavir diklorida).
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 60 mg of daclatasvir (as dihydrochloride).
Jedna filmom obložena tableta sadrži 60 mg daklatazvira (u obliku daklatazvir diklorida).
MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/003 28 tablets (calendar pack) EU/1/14/939/004 28 x 1 tablet
EU/1/14/939/003 28 tableta (kalendarski označeno pakiranje)
Impact of baseline NS5A RAVs on cure rates
Utjecaj početnih varijanti proteina NS5A koje su povezane s rezistencijom na stope izlječenja
Dose modification, interruption and discontinuation Dose modification of Daklinza to manage adverse reactions is not recommended.
Ne preporučuje se prilagođavanje doze lijeka Daklinza radi zbrinjavanja nuspojava.
ND
U
↑ Dabigatran etexilate
očekuje se: ↑ dabigatran eteksilat
↓ Daclatasvir
↔ midazolam
Expected due to CYP3A4 inhibition by the antibacterial:
Budući da antibakterijski lijekovi inhibiraju CYP3A4, očekuje se: ↑ daklatazvir
P-gp inhibition by daclatasvir
Daklatazvir inhibira P-gp.
Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) Tenofovir disoproxil fumarate 300 mg once daily (daclatasvir 60 mg once daily)
tenofovir dizoproksilfumarat 300 mg jedanput na dan (daklatazvir 60 mg jedanput na dan)
Expected due to CYP3A4 inhibition by boceprevir:
Budući da boceprevir inhibira CYP3A4,
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Daklinza is given for 24 weeks, in combination with 24-48 weeks of peginterferon alfa and ribavirin: - If HCV RNA is undetectable at both treatment weeks 4 and 12, all 3 components of the regimen should be continued for a total duration of 24 weeks.
Daklinza se primjenjuje tijekom 24 tjedna, u kombinaciji s 24 - 48 tjedana liječenja peginterferonom alfa i ribavirinom:
Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 90 mg daclatasvir.
Jedna filmom obložena tableta sadrži daklatazvir diklorid u količini koja odgovara 90 mg daklatazvira Pomoćne tvari s poznatim učinkom
No dose adjustment of Daklinza or dolutegravir is required.
Nije potrebno prilagođavati dozu lijeka Daklinza ni dolutegravira.
Do not take Daklinza if you are allergic to daclatasvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet) if you are taking (by mouth or other ways that affect the whole body) any of the following medicines - phenytoin, carbamazepine, oxcarbazepine or phenobarbital, used to treat epileptic seizures - rifampicin, rifabutin or rifapentine, antibiotics used to treat tuberculosis - dexamethasone, a steroid used to treat allergic and inflammatory diseases - medicines containing St. John's wort (Hypericum perforatum, a herbal preparation).
ako uzimate (kroz usta ili na drugi način koji utječe na cijelo tijelo) neki od sljedećih lijekova - fenitoin, karbamazepin, okskarbazepin ili fenobarbital, koji se koriste za liječenje epileptičkih napadaja
ANTICONVULSANTS
ANTIMIKOBAKTERIJSKI
Expected due to CYP3A4 inhibition by atazanavir/cobicistat: ↑ Daclatasvir
CYP3A4, očekuje se: ↑ daklatazvir flukonazol
Expected due to CYP3A4 inhibition by the antifungal:
Budući da kobicistat inhibira CYP3A4 očekuje se ↑ daklatazvir
Response was rapid (at Week 4 91% of daclatasvir-treated patients had HCV RNA <LLOQ).
Ishodi liječenja iz ispitivanja AI444042 prikazani su u Tablici 13. Odgovor je bio brz (u 4. tjednu je 91% bolesnika liječenih daklatazvirom imalo HCV RNK <LLOQ).
If you get any side effects, talk to your doctor or pharmacist.
Uputama o lijeku, obratite se svom liječniku ili ljekarniku.
Non-nucleoside reverse transcriptase inhibitors (NNRTIs) Efavirenz 600 mg once daily (daclatasvir 60 mg once daily/120 mg once daily)
efavirenz 600 mg jedanput na dan (daklatazvir 60 mg jedanput na dan/120 mg jedanput na dan)
Bristol-Myers Squibb GmbH & Co. KGaA Tel: + 49 89 121 42-0
KGaA Tel: + 49 89 121 42-0
Darunavir/cobicistat
Preporuke za istodobnu primjenu darunavir/kobicistat
Hepatic impairment
Prethodno neliječeni bolesnici
ANTIVIRALS, HIV or HBV Protease inhibitors (PIs) Atazanavir 300 mg/ritonavir 100 mg once daily (daclatasvir 20 mg once daily)
atazanavir 300 mg/ritonavir 100 mg jedanput na dan (daklatazvir 20 mg jedanput na dan)
AUC: 1.37 (1.24, 1.52) Cmax: 1.30 (1.03, 1.64) Cmin: 1.17 (1.03, 1.32)
↔↑ buprenorfin AUC: 1,37 (1,24, 1,52)Cmax: 1,30 (1,03;
Palpitations
ANTIDEPRESIVI
Expected due to CYP3A4 and P-gp inhibition by verapamil:
Budući da verapamil inhibira CYP3A4 i
ANTIMYCOBACTERIALS Rifampicin 600 mg once daily (daclatasvir 60 mg single dose)
LIJEKOVI rifampicin 600 mg jedanput na dan
NAME OF THE MEDICINAL PRODUCT Daklinza 30 mg film-coated tablets daclatasvir
Daklinza 30 mg filmom obložene tablete daklatazvir
Hypromellose
IMUNOSUPRESIVI
Category/ Substitution, n (%)
HCV-om genotipa 1 - 3 koji nisu postigli SVR12 Kategorija/ supstitucija, n (%)
Expected due to CYP3A4 induction by the anticonvulsant:
CYP3A4, očekuje se:
Fainting
• nesvjesticu
Other HCV antivirals
Prethodno neliječeni za HCV
Expected: ↔ Daclatasvir
očekuje se: ↑ daklatazvir
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Virologic failure
↔ ciklosporin
Digoxin 0.125 mg once daily (daclatasvir 60 mg once daily)
LIJEKOVI S DJELOVANJEM NA KARDIOVASKULARNI SUSTAV Antiaritmici digoksin 0,125 mg jedanput na dan (daklatazvir 60 mg jedanput na dan)
BRISTOL-MYERS SQUIBB A.E. Τηλ: + 30 210 6074300
Τηλ: + 30 210 6074300
Route of administration Immediate Packaging Pack size
Put primjene Unutarnje pakovanje
90 (3 x 30) tablets
90 (3 x 30) tableta
Pharmaceutical Form Route of Administration
Farmaceutski oblik Put primjene
Packaging Package size l t o r
Veličina pakovanja koncentrat za otopinu za infuziju
EU Number
EMA broj postupka ime
Therefore, your doctor may decide that you should not use this medicine.
Stoga vaš liječnik može odlučiti da ne smijete uzimati ovaj lijek.
The experience in children and adolescents is limited.
Iskustvo u djece i adolescenata je ograničeno.
117 allée des Parcs 69800 Saint-Priest France
117 allée des Parcs 69800 Saint-Priest Francuska
- nausea and headaches.
- mučnina i glavobolje.
• Any part appears cracked or broken.
• Ako bilo koji dio štrcaljke izgleda napuknut ili slomljen.
- some changes may occur in your blood, but these will be detected by routine blood tests.
- moguće su i promjene u krvi, ali one će se otkriti prilikom rutinskih krvnih pretraga.
Fulphila is not recommended for use in children and adolescents due to insufficient data on safety and effectiveness.
Fulphila se ne preporučuje za primjenu u djece i adolescenata zbog nedostatnih podataka o sigurnosti i djelotvornosti.
Remove the syringe from the refrigerator.
Izvadite štrcaljku iz hladnjaka.
B PUSH the plunger with slow and constant pressure until you feel or hear a “snap”.
B GURAJTE klip polaganim i postojanim pritiskom dok ne osjetite ili ne čujete “škljoc”.
If there are particles in it, you must not use it.
Ako sadrži vidljive čestice, ne smijete ga koristiti.
 Do not try to warm the syringe by using a heat source such as hot water or microwave.
 Ne pokušavajte ugrijati štrcaljku korištenjem izvora topline kao što su vruća voda ili mikrovalna pećnica.
Common (≥ 1/100 to < 1/10)
(≥ 1/100 do < 1/10)
Fulphila has not been tested in pregnant women.
Fulphila nije ispitivana u trudnica.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 November 2018
Datum prvog odobrenja: 20. studenog 2018.
Do not warm the syringe in any other way (for example, do not warm it in a microwave or in hot water).
Ne zagrijavajte štrcaljku ni na koji drugi način (primjerice, u mikrovalnoj pećnici ili u vrućoj vodi).
Sweet's syndrome (acute febrile dermatosis)1,2;
Sweetov sindrom (akutna febrilna dermatoza)1,2;
Stop using Fulphila and seek medical attention immediately if you notice any of the symptoms described in section 4.
Prestanite s primjenom lijeka Fulphila i odmah potražite medicinsku pomoć ako primijetite bilo koji od simptoma opisanih u dijelu 4.
If you become pregnant during Fulphila treatment, please inform your doctor.
Ukoliko zatrudnite tijekom primjene lijeka Fulphila, molimo obavijestite liječnika.
Only use each syringe for one injection.
Zapamtite Svaku štrcaljku koristite samo za jedno injiciranje.
Do not inject into areas where the skin is tender, bruised, red, or hard.
Ne primjenjujte injekciju na područjima gdje je koža osjetljiva, s modricama, crvena ili tvrda.
1 See section “Description of selected adverse reactions” below.
1 Vidjeti dio „Opis odabranih nuspojava“ ispod.
Important Before you use a Fulphila pre-filled syringe with automatic needle guard, read this important information:
Prije korištenja Fulphila napunjene štrcaljke s automatskim štitnikom za iglu, pročitajte ove važne informacije:
Your doctor may decide that it would be more convenient for you to inject Fulphila yourself.
Vaš liječnik može odlučiti da će Vam biti pogodnije ako si sami injicirate lijek Fulphila.
What Fulphila is and what it is used for
Što je Fulphila i za što se koristi
Fulphila is for use in adults aged 18 and over.
Fulphila se primjenjuje u odraslih osoba starijih od 18 godina.
Fulphila left at room temperature for more than 72 hours should be discarded.
Fulphila ostavljena na sobnoj temperaturi dulje od 72 sata mora se baciti.
Do not shake Fulphila vigorously as this may affect its activity.
Ne tresite snažno lijek Fulphila jer to može utjecati na njegovu aktivnost.
After injecting the liquid, remove the needle and let go of your skin.
Nakon injiciranja tekućine, izvucite iglu i pustite kožu.
 Do not use the pre-filled syringe if it has been dropped on a hard surface.
 Ne upotrebljavajte napunjenu štrcaljku ako je prethodno pala na tvrdu površinu.
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka mora se jasno zabilježiti.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Fulphila therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Nužno je donijeti odluku o tome treba li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Fulphila uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
B Carefully pull the grey needle cap straight out and away from your body.
B Pažljivo i ravno povucite sivu kapicu s igle dalje od Vašeg tijela.
Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in association with pegfilgrastim treatment.
Steven-Johnsonov sindrom, koji može biti životno ugrožavajući ili smrtonosan, rijetko je prijavljen kod liječenja pegfilgrastimom.
Specific interaction or metabolism studies have not been performed, however, clinical trials have not indicated an interaction of pegfilgrastim with any other medicinal products.
Nisu provedena specifična ispitivanja interakcija ili metabolizma, no klinička ispitivanja nisu upućivala na interakciju pegfilgrastima s bilo kojim drugim lijekovima.
Fulphila may be used if it is accidentally frozen for a single period of less than 24 hours.
Fulphila se može upotrijebiti ako je bila slučajno zamrznuta u jednokratnom razdoblju kraćem od 24 sata.
Your doctor will check your blood and urine regularly as Fulphila can harm the tiny filters inside your kidneys (glomerulonephritis).
Vaš će liječnik redovito provjeravati Vašu krv i mokraću jer Fulphila može oštetiti sitne filtre unutar Vaših bubrega (glomerulonefritis).
Other medicines and Fulphila
Drugi lijekovi i Fulphila
The frequency category was estimated from a statistical calculation based upon 1,576 patients receiving pegfilgrastim in nine randomised clinical trials.
Kategorija učestalosti je procijenjena statističkim izračunom na temelju 1576 bolesnika koji su pegfilgrastim primali u devet randomiziranih kliničkih ispitivanja.
BATCH NUMBER Lot:
13. BROJ SERIJE Lot:
Stop using Fulphila if you develop these symptoms and contact your doctor or seek medical attention immediately.
Prestanite koristiti lijek Fulphila ako razvijete ove simptomi i obratite se liječniku ili odmah potražite medicinsku pomoć.
What you need to know before you use Fulphila Do not use Fulphila - if you are allergic to pegfilgrastim, filgrastim or any of the other ingredients of this medicine (listed in section 6).
Što morate znati prije nego počnete primjenjivati lijek Fulphila Nemojte primjenjivati lijek Fulphila - ako ste alergični na pegfilgrastim, filgrastim ili neki drugi sastojak ovog lijeka (pogledajte dio 6.).
 Do not recycle pre-filled syringes or throw them into household waste.
X Nemojte reciklirati iskorištene štrcaljke ili ih bacati u kućni otpad.
Check the appearance of Fulphila.
Provjerite izgled lijeka Fulphila.
In animal models concomitant administration of pegfilgrastim and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Na životinjskim modelima se pokazalo da je istodobna primjena pegfilgrastima i 5-fluorouracila (5-FU) ili drugih antimetabolita potencirala mijelosupresiju.
Push the plunger all the way down as far as it will go to inject all the liquid.
Gurajte klip do kraja dokle god je moguće kako biste injicirali svu tekućinu.
Once a syringe has been removed from the refrigerator and has reached room temperature (not above 30°C) it must either be used within 3 days or disposed of.
Kada štrcaljku jednom izvadite iz hladnjaka te ona dosegne sobnu temperaturu (ne višu od 30 °C), mora se upotrijebiti u roku od 3 dana ili baciti.
• Fulphila is given as an injection into the tissue just under the skin (subcutaneous injection).
Fulphila se daje kao injekcija u tkivo odmah ispod kože (supkutana injekcija).
Always use this medicine exactly as your doctor has told you.
Uvijek primijenite lijek Fulphila točno onako kako Vam je rekao liječnik.
• The medicine is cloudy or there are particles in it.
• Ako lijek izgleda mutan ili su u njemu vidljive čestice.
The safety and efficacy of pegfilgrastim in children has not yet been established.
Sigurnost i djelotvornost pegfilgrastima u djece nisu još ustanovljene.
Clean your skin by using an alcohol wipe.
Očistite kožu koristeći maramicu natopljenu alkoholom.
Common cases of leukocytosis (White Blood Count [WBC] > 100 x 109/l) have been reported (see section 4.4).
Prijavljeni su česti slučajevi leukocitoze (broj leukocita > 100 × 109/L) (vidjeti dio 4.4).