natgillin/translations-raw huggingface dataset:
Posology PREVYMIS is also available for oral administration (240 mg and 480 mg film-coated tablets). 
PREVYMIS je dostupan i u obliku za peroralnu primjenu (filmom obložene tablete od 240 mg i 480 mg).
Co-administration of PREVYMIS and nevirapine is not recommended. 
Istodobna primjena lijeka PREVYMIS i nevirapina se ne preporučuje.
Each 12 mL vial contains 240 mg letermovir. 
Jedna bočica od 12 ml sadrži 240 mg letermovira.
• Tigecycline 
• ganciklovirnatrij tigeciklin
• Daptomycin 
• daptomicin mikafungin
Each film-coated tablet contains 240 mg of letermovir. 
Jedna filmom obložena tableta sadrži 240 mg letermovira.
Each film-coated tablet contains 480 mg of letermovir. 
Jedna filmom obložena tableta sadrži 480 mg letermovira.
Sedatives midazolam (1 mg single dose IV)/ letermovir (240 mg once daily PO) 
Sedativi midazolam (jedna doza od 1 mg i.v.)/letermovir (240 mg jedanput na dan peroralno)
Letermovir may decrease the plasma concentrations of dabigatran and may decrease efficacy of dabigatran. 
Letermovir može sniziti koncentracije dabigatrana u plazmi i smanjiti njegovu djelotvornost.
31 May 2020 (PACMP Step 2) 
(2. korak prema PACMP-u)
Close clinical monitoring should be exercised during administration of PREVYMIS with quinidine. 
Kod istodobne primjene lijeka PREVYMIS i kinidina potrebno je pažljivo pratiti klinički status bolesnika.
PREVYMIS 240 mg concentrate for solution for infusion PREVYMIS 480 mg concentrate for solution for infusion 
240 mg koncentrat za otopinu za infuziju PREVYMIS 480 mg koncentrat za otopinu za infuziju
Blister for 240 mg film-coated tablets 
Blister za 240 mg filmom obložene tablete
The recommended dose of PREVYMIS is 480 mg once a day. 
Preporučena doza lijeka PREVYMIS je 480 mg jedanput na dan.
↔ acyclovir AUC 1.02 (0.87, 1.2) Cmax 0.82 (0.71, 0.93) 
↔ aciklovir AUC 1,02 (0,87; 1,2) Cmax 0,82 (0,71; 0,93)
(600 mg once daily PO)/ letermovir (480 mg once daily PO) 
(600 mg jedanput na dan peroralno)/ letermovir (480 mg jedanput na dan peroralno)
If PREVYMIS is co-administered with cyclosporine, the dosage of PREVYMIS should be decreased to 240 mg once daily (see sections 4.5 and 5.2). 
Ako se PREVYMIS primjenjuje istodobno s ciklosporinom, dozu lijeka PREVYMIS treba smanjiti na 240 mg jedanput na dan (vidjeti dijelove 4.5 i 5.2).
Hepatobiliary disorders Uncommon alanine aminotransferase increased, aspartate aminotransferase increased 
Poremećaji jetre i žuči Manje često povišene vrijednosti alanin aminotransferaze, povišene vrijednosti aspartat aminotransferaze Poremećaji mišićno-koštanog sustava i vezivnog tkiva Manje često grčevi u mišićima
Letermovir may increase the plasma concentrations of amiodarone. 
Letermovir može povisiti koncentracije amiodarona u plazmi.
Each 24 mL vial contains 480 mg of letermovir. 
Jedna bočica od 24 ml sadrži 480 mg letermovira.
midazolam (2 mg single dose PO) / letermovir (240 mg once daily PO) 
midazolam (jedna doza od 2 mg peroralno)/letermovir (240 mg jedanput na dan peroralno)
sirolimus (2 mg single dose)/ letermovir (480 mg daily) 
sirolimus (jedna doza od 2 mg)/letermovir (480 mg na dan)
PREVYMIS 240 mg tablets letermovir 
240 mg tablete letermovir
Each 240 mg dose (12 mL vial) of this medicine contains 1800 mg cyclodextrin. 
Jedna doza lijeka od 240 mg (bočica od 12 ml) sadrži 1800 mg ciklodekstrina.
PREVYMIS vials are for single use only. 
PREVYMIS bočice namijenjene su samo za jednokratnu primjenu.
PREVYMIS should not be administered as an intravenous push or bolus. 
PREVYMIS se ne smije primijeniti brzom ili bolusnom intravenskom injekcijom.
240 mg film-coated tablets 
240 mg filmom obložene tablete
Blister for 480 mg film-coated tablets 
Blister za 480 mg filmom obložene tablete
Co-administration of PREVYMIS and thioridazine is not recommended. 
Istodobna primjena lijeka PREVYMIS i tioridazina se ne preporučuje.
• Fluconazole 
• vorikonazola
Co-administration of PREVYMIS and etravirine is not recommended. 
Istodobna primjena lijeka PREVYMIS i etravirina se ne preporučuje.
(Sum of OATP1B1/3 and/or Pgp inhibition and P-gp/UGT induction) 
(Zbroj inhibicije OATP1B1/3 i/ili P-gp-a i indukcije P-gp-a/UGT-a)
Co-administration of PREVYMIS and bosentan is not recommended. 
Istodobna primjena lijeka PREVYMIS i bosentana se ne preporučuje.
Expected: ↔ valacyclovir 
Očekivano: ↔ valaciklovir
• Ceftriaxone sodium 
• ceftarolin pantoprazolnatrij
If PREVYMIS is co-administered with cyclosporine, the dosage of PREVYMIS should be decreased to 240 mg once daily (see sections 4.2 and 5.1). 
Ako se PREVYMIS primjenjuje istodobno s ciklosporinom, dozu lijeka PREVYMIS treba smanjiti na 240 mg jedanput na dan (vidjeti dijelove 4.2 i 5.1).
Co-administration of PREVYMIS and nafcillin is not recommended. 
Istodobna primjena lijeka PREVYMIS i nafcilina se ne preporučuje.
Letermovir may decrease the plasma concentrations of warfarin. 
Letermovir može sniziti koncentracije varfarina u plazmi.
PREVYMIS 240 mg concentrate for solution for infusion PREVYMIS 480 mg concentrate for solution for infusion letermovir 
240 mg koncentrat za otopinu za infuziju PREVYMIS 480 mg koncentrat za otopinu za infuziju letermovir
Antifungals fluconazole (400 mg single dose)/letermovir (480 mg single dose) 
Antimikotici flukonazol (jedna doza od 400 mg)/letermovir (jedna doza od 480 mg)
Refer to the respective prescribing information 
Vidjeti odgovarajuće informacije o lijeku
480 mg film-coated tablets 
480 mg filmom obložene tablete
Uncommon abdominal pain 
Manje često bol u abdomenu
Letermovir may increase the plasma concentrations of quinidine. 
Letermovir može povisiti koncentracije kinidina u plazmi.
(CYP2C9/19 induction) 
(indukcija CYP2C9/19)
(OATP1B1/3 and/or P-gp inhibition) 
(inhibicija OATP1B1/3 i/ili P-gp-a)
(OATP1B1/3 and/or BCRP inhibition) 
(inhibicija OATP1B1/3 i/ili BCRP-a)
PREVYMIS 240 mg film-coated tablets PREVYMIS 480 mg film-coated tablets 
240 mg filmom obložene tablete PREVYMIS 480 mg filmom obložene tablete
tacrolimus (5 mg single dose)/ letermovir (480 mg daily) 
takrolimus (jedna doza od 5 mg)/letermovir (480 mg na dan)
Rifabutin may decrease plasma concentrations of letermovir. 
Rifabutin može sniziti koncentracije letermovira u plazmi.
Discard if discolouration or visible particles are observed. 
Bacite je ako primijetite da je promijenila boju ili da sadrži vidljive čestice.
Letermovir may increase the plasma concentrations of glyburide. 
Letermovir može povisiti koncentracije gliburida u plazmi.
When PREVYMIS is co-administered with cyclosporine, the magnitude of the increase in concentrations of sirolimus may be greater than with PREVYMIS alone. 
Porast koncentracija sirolimusa može biti veći kada se PREVYMIS primjenjuje istodobno s ciklosporinom nego kada se PREVYMIS primjenjuje sam.
PREVYMIS 240 mg film-coated tablets PREVYMIS 480 mg film-coated tablets letermovir 
240 mg filmom obložene tablete PREVYMIS 480 mg filmom obložene tablete letermovir
This should be taken into consideration by patients on a controlled sodium diet. PREVYMIS 480 mg concentrate for solution for infusion contains 46 mg (or 2.0 mmol) sodium per dose. 
PREVYMIS 480 mg koncentrat za otopinu za infuziju sadrži 46 mg (ili 2,0 mmol) natrija po dozi.
How you are given PREVYMIS 
Kako ćete primati PREVYMIS
Modafinil may decrease plasma concentrations of letermovir. 
Modafinil može sniziti koncentracije letermovira u plazmi.
Bioavailability of letermovir was estimated to be approximately 85% with 240 mg once daily oral letermovir co-administered with cyclosporine in patients. 
Kada se letermovir bolesnicima primjenjivao peroralno u dozi od 240 mg jedanput na dan zajedno s ciklosporinom, procijenjena bioraspoloživost letermovira iznosila je približno 85%.
Antivirals acyclovir (400 mg single dose)/ letermovir (480 mg daily) 
Antivirotici aciklovir (jedna doza od 400 mg)/letermovir (480 mg na dan)
Efficacy and safety has not been demonstrated for patients with ESRD. 
Djelotvornost i sigurnost nisu dokazane u bolesnika u terminalnoj fazi bubrežne bolesti.
Breast-feeding is not recommended while taking PREVYMIS. 
Ne preporučuje se primjena lijeka PREVYMIS tijekom dojenja.
• Potassium chloride 
• ceftriaksonnatrij kalijev klorid
mycophenolate mofetil (1 g single dose)/ letermovir (480 mg daily) 
mofetilmikofenolat (jedna doza od 1 g)/letermovir (480 mg na dan)
(600 mg single dose IV)/ letermovir (480 mg single dose PO) 
(jedna doza od 600 mg i.v.)/ letermovir (jedna doza od 480 mg peroralno)
PREVYMIS 480 mg film-coated tablets 
PREVYMIS 480 mg filmom obložene tablete
• Once diluted, the solution of PREVYMIS is clear, and ranges from colourless to yellow. 
• Otopina lijeka PREVYMIS je nakon razrjeđivanja bistra te bezbojna do žuta.
↑ cyclosporine AUC 1.66 (1.51, 1.82) Cmax 1.08 (0.97, 1.19) (CYP3A inhibition) 
↑ ciklosporin AUC 1,66 (1,51; 1,82) Cmax 1,08 (0,97; 1,19)
(CYP2C9 induction) 
(indukcija CYP2C9)
Name and address of the manufacturer(s) responsible for batch release Schering-Plough Labo NV 
Naziv i adresa proizvođača odgovornog(ih) za puštanje serije lijeka u promet
Outer carton for 240 mg concentrate for solution for infusion 
Kutija za 240 mg koncentrat za otopinu za infuziju
PREVYMIS 240 mg sterile concentrate letermovir 
240 mg sterilni koncentrat letermovir
Vial label for 480 mg concentrate for solution for infusion 
Naljepnica bočice za 480 mg koncentrat za otopinu za infuziju
Vial label for 240 mg concentrate for solution for infusion 
Naljepnica bočice za 240 mg koncentrat za otopinu za infuziju
Lactose monohydrate 
hidrokortizonnatrij sukcinat
The mean apparent terminal half-life for letermovir is approximately 12 hours with 480 mg IV letermovir in healthy subjects. 
Kod primjene letermovira zdravim ispitanicima u dozi od 480 mg i.v., srednja vrijednost prividnog terminalnog poluvijeka letermovira iznosi približno 12 sati.
Outer carton for 480 mg concentrate for solution for infusion 
Kutija za 480 mg koncentrat za otopinu za infuziju
How to store PREVYMIS 
Kako čuvati PREVYMIS
PREVYMIS 480 mg film-coated tablets letermovir 
PREVYMIS 480 mg filmom obložene tablete letermovir
• Potassium phosphate 
• doripenem kalijev fosfat
If you are breast-feeding or are planning to breast-feed, tell your doctor before taking this medicine. 
Ako dojite ili planirate dojiti, obratite se svom liječniku prije nego što uzmete ovaj lijek.
Once diluted, the solution of PREVYMIS is clear, and ranges from colourless to yellow. 
Otopina lijeka PREVYMIS je nakon razrjeđivanja bistra te bezbojna do žuta.
PREVYMIS is not recommended in pregnancy. 
Ne preporučuje se primjena lijeka PREVYMIS u trudnoći.
Nafcillin may decrease plasma concentrations of letermovir. 
Nafcilin može sniziti koncentracije letermovira u plazmi.
• Telavancin 
• mučnina
If concomitant administration is necessary, TDM for voriconazole is recommended the first 2 weeks after initiating or ending letermovir, as well as after changing route of administration of letermovir or immunosuppressant. 
Preporučuje se praćenje tijekom prva 2 tjedna nakon uvođenja ili nakon prekida primjene letermovira, kao i nakon promjene puta primjene letermovira ili promjene imunosupresiva.
General disorders and administration site conditions Uncommon fatigue, oedema peripheral 
Opći poremećaji i reakcije na mjestu primjene Manje često umor, periferni edem
Stem Cell Source 
Izvor matičnih stanica
Antidiabetic medicinal products repaglinide 
Antidijabetici repaglinid
Bosentan may decrease plasma concentrations of letermovir. 
Bosentan može sniziti koncentracije letermovira u plazmi.
(OATP1B1/3 inhibition) 
(inhibicija OATP1B1/3)
Nevirapine may decrease plasma concentrations of letermovir. 
Nevirapin može sniziti koncentracije letermovira u plazmi.
Ear and labyrinth disorders Uncommon vertigo 
Poremećaji uha i labirinta Manje često vrtoglavica
(P-gp/UGT induction) 
(indukcija P-gp-a/UGT-a)
Efavirenz may decrease plasma concentrations of letermovir. 
Efavirenz može sniziti koncentracije letermovira u plazmi.
(600 mg single dose PO)/ letermovir (480 mg single dose PO) 
(jedna doza od 600 mg peroralno)/ letermovir (jedna doza od 480 mg peroralno)
Etravirine may decrease plasma concentrations of letermovir. 
Etravirin može sniziti koncentracije letermovira u plazmi.
Letermovir may decrease the plasma concentrations of phenytoin. 
Letermovir može sniziti koncentracije fenitoina u plazmi.
PREVYMIS 240 mg concentrate for solution for infusion letermovir 
240 mg koncentrat za otopinu za infuziju letermovir
Frequent monitoring of sirolimus whole blood concentrations should be performed during treatment, when changing PREVYMIS administration route, and at discontinuation of PREVYMIS and the dose of sirolimus adjusted accordingly Frequent monitoring of sirolimus concentrations is recommended at initiation or discontinuation of cyclosporine coadministration with PREVYMIS. 
Potrebno je često kontrolirati koncentracije sirolimusa u punoj krvi tijekom liječenja, kada se mijenja put primjene lijeka PREVYMIS i po prestanku liječenja lijekom PREVYMIS te sukladno njima prilagoditi dozu sirolimusa
• Inspect vial contents for discolouration and particulate matter prior to dilution. 
• Sadržaj bočice treba prije razrjeđivanja pregledati kako bi se utvrdilo je li promijenio boju i sadrži li čestice.
PREVYMIS 480 mg concentrate for solution for infusion letermovir 
PREVYMIS 480 mg koncentrat za otopinu za infuziju letermovir
The 240 mg and 480 mg concentrate for solution for infusion is packaged in clear, glass vials. 
Koncentrat za otopinu za infuziju od 240 mg i 480 mg dolazi u prozirnim staklenim bočicama.
Recommendations concerning coadministration with PREVYMIS 
Preporuke za istodobnu primjenu s lijekom PREVYMIS
PREVYMIS is not recommended in patients with moderate hepatic impairment combined with moderate or severe renal impairment (see section 5.2). 
Istodobno oštećenje funkcije jetre i funkcije bubrega Primjena lijeka PREVYMIS ne preporučuje se u bolesnika s umjerenim oštećenjem funkcije jetre koji uz to imaju i umjereno ili teško oštećenje funkcije bubrega (vidjeti dio 5.2).
Thioridazine may decrease plasma concentrations of letermovir. 
Tioridazin može sniziti koncentracije letermovira u plazmi.
Letermovir may increase statin plasma concentrations. 
Letermovir može povisiti koncentracije statina u plazmi.
PREVYMIS 240 mg film-coated tablets letermovir 
240 mg filmom obložene tablete letermovir
Thirty-seven percent (37%) of subjects were engrafted at baseline. 
U 37% ispitanika je na početku ispitivanja transplantat bio prihvaćen.
Refer to the respective prescribing information. 
Vidjeti odgovarajuće informacije o lijeku.
Phenytoin may decrease plasma concentrations of letermovir. 
Fenitoin može sniziti koncentracije letermovira u plazmi.
• Tacrolimus 
• proljev
Iron oxide yellow (E172) Iron oxide red (only for 480 mg tablets) (E172) Carnauba wax (E903) 
Film ovojnica laktoza hidrat hipromeloza (E464) titanijev dioksid (E171) triacetin (E1518) željezov oksid, žuti (E172) željezov oksid, crveni (samo za tablete od 480 mg) (E172) karnauba vosak (E903)
Expected: ↑ glyburide 
Očekivano: ↑ gliburid
Close clinical monitoring for respiratory depression and/or prolonged sedation should be exercised during coadministration of PREVYMIS with midazolam. 
Kod istodobne primjene lijeka PREVYMIS i midazolama potrebno je pažljivo pratiti klinički status bolesnika zbog moguće depresije disanja i/ili produljene sedacije.
↔ fluconazole AUC 1.03 (0.99, 1.08) Cmax 0.95 (0.92, 0.99) ↔ letermovir AUC 1.11 (1.01, 1.23) Cmax 1.06 (0.93, 1.21) 
↔ flukonazol AUC 1,03 (0,99; 1,08) Cmax 0,95 (0,92; 0,99)
Administer the entire contents of the IV 
Primijenite cijeli sadržaj infuzijske vrećice.
When PREVYMIS is co-administered with cyclosporine, the magnitude of the increase in plasma concentrations of CYP3A metabolised opioids may be greater. 
Koncentracije opioida u plazmi koji se metaboliziraju putem CYP3A mogle bi porasti još više kada se PREVYMIS primjenjuje istodobno s ciklosporinom.
Excipients 
PREVYMIS
Co-administration of PREVYMIS and St. John's wort is contraindicated. 
Istodobna primjena lijeka PREVYMIS i gospine trave je kontraindicirana.
Cardiovascular medicinal products digoxin (0.5 mg single dose)/ letermovir (240 mg twice daily) 
0,5 mg)/letermovir (240 mg dvaput na dan)
• Anti-thymocyte globulin 
Antipsihotici tioridazin
Frequent monitoring of sirolimus whole blood concentrations should be performed during treatment, when changing PREVYMIS administration route, and at discontinuation of PREVYMIS and the dose of sirolimus adjusted accordingly Frequent monitoring of sirolimus concentrations is recommended at initiation or discontinuation of cyclosporine co administration with PREVYMIS. 
Preporučuje se često kontrolirati koncentracije sirolimusa pri uvođenju ili prekidu istodobne primjene ciklosporina i lijeka PREVYMIS.
--¹ not less than 10E6.0 CCID50 
Ne manje od 10E6.0 CCID50
1 glass container + 1 oral applicator + 1 transfer adapter 
1 stakleni spremnik+ 1 oralni aplikator + 1 nastavak za prijenos
1 squeezable tube multi-monodose (5 single dose) squeezable tube (polyethylene) presentation connected by a bar 
1 oralni aplikator više jednodoznih tuba (5 pojedinačnih doza) za istiskivanje (poletilen) spojenih trakom
1 oral applicator 
Zaštićeno ime
Therefore, patients must be monitored closely. 
Bolesnike, stoga, treba pažljivo nadzirati.
It will be given once a day, for up to 7 days. 
Lijek ćete dobivati jednom dnevno, do najdulje 7 dana.
These may be the first signs that a severe allergic reaction is happening. 
To mogu biti prvi znakovi da se događa ozbiljna alergijska reakcija.
Date of latest renewal: 23 February 2006 
Datum posljednje obnove: 23. veljače 2006.
Inspect visually prior to use. 
Vizualno provjerite otopinu prije uporabe.
Tell your doctor immediately if you notice any of the following as you may need to stop treatment: 
Odmah recite svom liječniku ako primijetite bilo što od sljedećeg jer ćete možda morati prekinuti liječenje:
1 mg corresponds to 18.2 EAU*. 
1 mg odgovara aktivnosti od 18,2 EAU*.
Via Valcanello, 4 03012 Anagni (FR) Italy 
Via Valcanello, 4 03012 Anagni (FR) Italija
The powder is an entire or broken white to off white pellet. 
Prašak je cjelovita ili izlomljena bijela do gotovo bijela peleta.
Please tell your doctor if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. 
Obavijestite svog liječnika ako uzimate ili ste nedavno uzimali bilo koje druge lijekove, uključujući i lijekove koje ste nabavili bez recepta.
Fasturtec is supplied as a pack of: 
Fasturtec je dostupan u pakiranju od:
Your treatment with Fasturtec may need to be stopped, and you may need further treatment. 
Možda će biti potrebno prekinuti Vaše liječenje lijekom Fasturtec i možda ćete trebati daljnje liječenje.
Dilution before infusion: 
Razrjeđivanje prije infuzije:
What Fasturtec looks like and contents of the pack 
Kako Fasturtec izgleda i sadržaj pakiranja
It is not known whether the chance of developing an allergic reaction is increased if treatment with Fasturtec is repeated. 
Nije poznato povećava li se vjerojatnost za razvoj alergijske reakcije ako se liječenje lijekom Fasturtec ponovi.
No filter should be used for infusion. 
Za infuziju ne treba koristiti filter.
- Allergy/ allergic reactions (rashes and urticaria) 
- alergija/ alergijske reakcije (osipi i urtikarija)
9 SPECIAL STORAGE CONDITIONS Store in a refrigerator 
9 POSEBNE MJERE ČUVANJA Čuvati u hladnjaku.
Other medicines and Fasturtec 
Drugi lijekovi i Fasturtec
- Convulsion** 
- konvulzije **
Your doctor may also test your blood to make sure that you do not develop any blood disorders. 
Liječnik Vam također može provoditi krvne pretrage kako bi se ustanovilo imate li bilo kakav poremećaj krvi.
Do not use this medicine if you notice that the solution is unclear and/or contains particles. 
Ovaj lijek se ne smije upotrijebiti ako primijetite da otopina nije bistra i/ili da sadrži čestice.
What Fasturtec is and what it is used for 
Što je Fasturtec i za što se koristi
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity. 
Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih farmakoloških ispitivanja sigurnosti primjene, toksičnosti ponovljenih doza i genotoksičnosti.
These are rare (may affect up to 1 in 1,000 people). 
Te su reakcije rijetke (mogu se javiti u manje od 1 na 1000 osoba).
- Severe hypersensitivity reactions 
- teške reakcije preosjetljivosti
In case of severe allergic reaction, treatment should immediately and permanently be discontinued and appropriate therapy initiated. 
U slučaju teške alergijske reakcije, mora se odmah i trajno obustaviti liječenje te započeti s odgovarajućom terapijom.
Frequencies are defined using the following MedDRA convention as: 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), not known (cannot be estimated from the available data). 
Učestalost pojavljivanja definirana je prema MedDRA klasifikaciji kao: 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), nepoznato (ne može se procijeniti iz dostupnih podataka).
As a protein the dose for the infant is expected to be very low. 
Budući da se radi o proteinu, očekuje se da će doza koju će dojenče primiti biti vrlo mala.
Your dose will be calculated according to your body weight. 
Liječnik će izračunati Vašu dozu prema Vašoj tjelesnoj težini.
Plasma samples should immediately be prepared by centrifugation in a pre-cooled centrifuge (4°C). 
Uzorke plazme treba odmah pripremiti centrifugiranjem u prethodno ohlađenoj centrifugi (4°C).
Clearance is increased (ca. 35%) in children and adolescents compared to adults, resulting in a lower systemic exposure. 
Klirens je u djece i adolescenata povećan (oko 35%) u usporedbi s odraslima, što rezultira nižom sistemskom izloženošću.
Fasturtec is not directly effective in the treatment of these abnormalities. 
Fasturtec nije izravno djelotvoran u liječenju tih poremećaja.
What you need to know before you are given Fasturtec 
Što morate znati prije nego počnete primati Fasturtec
Blood must be collected into pre-chilled tubes containing heparin anticoagulant. 
Krv se mora prikupljati u prethodno ohlađene spremnike koji sadrže heparinski antikoagulans.
The most commonly reported adverse reactions were nausea, vomiting, headache, fever, and diarrhea. 
Najčešće prijavljene nuspojave bile su mučnina, povraćanje, glavobolja, vrućica i proljev.
Rasburicase is a protein, and therefore: 1) not expected to bind to proteins, 2) expected that metabolic degradation will follow the pathways of other proteins, i.e. peptide hydrolysis, 3) unlikely to be candidate for drug-drug interactions. 
Razburikaza je protein te se stoga: 1) ne očekuje da se veže za proteine; 2) očekuje da će se metabolička razgradnja odvijati istim putem kao i razgradnja drugih proteina, tj. hidrolizom peptida; 3) smatra da nije kandidat za interakcije s drugim lijekovima.
If you suddenly notice: - a swelling of the face, lips, tongue or other part of your body - a shortness of breath, wheezing or breathing problems - a rash, itching or hives 
Ako iznenada primijetite: - oticanje lica, usana, jezika ili drugih dijelova tijela - nedostatak zraka, piskanje u plućima ili otežano disanje - osip, svrbež ili koprivnjaču
As metabolism is expected to occur by peptide hydrolysis, an impaired liver function is not expected to affect the pharmacokinetics. 
Budući da se očekuje da se metabolizam odvija putem hidrolize peptida, ne očekuje se da bi narušena funkcija jetre utjecala na farmakokinetiku.
Fasturtec will be administered at the same time as other medicines that may also cause side effects. 
Fasturtec ćete dobiti u isto vrijeme kad i druge lijekove koji također mogu uzrokovati nuspojave.
During treatment with Fasturtec, the advantage of breastfeeding should be weighted against the potential risk for the infant. 
Tijekom liječenja lijekom Fasturtec treba odvagnuti korist od dojenja u odnosu na mogući rizik za dojenče.
Sanofi Chimie Route d'Avignon 30390 Aramon France 
Sanofi Chimie Route d'Avignon 30390 Aramon Francuska