natgillin/translations-raw huggingface dataset:
The enzymatic digestion of uric acid to allantoin by rasburicase produces hydrogen peroxide and haemolytic anaemia or methaemoglobinaemia have been observed in certain at risk populations such as those with G6PD deficiency.
Zato so pri rizičnih skupinah, kot so bolniki s pomanjkanjem glukoza- 6- fosfat dehidrogenaze, opazili hemolitično anemijo in methemoglobinemijo.
In addition, grade 3 or 4 adverse reactions possibly attributable to Fasturtec and reported in the clinical trials, are listed below, by system organ class and by frequency.
Razdeljeni so po organskih sistemih in pogostosti.
Frequencies are defined as: common (≥ 1/ 100, < 1/ 10), uncommon (≥ 1/ 1,000, < 1/ 100).
Pogostost pojavljanja je opredeljena na naslednji način: pogosti (≥ 1/ 100, < 1/ 10), občasni (≥ 1/ 1. 000, < 1/ 100).
Uncommon Headache Diarrhoea
občasni glavobol diareja
Gastrointestinal disorders General disorders and administration site conditions
Bolezni prebavil Splošne težave in spremembe na
Fever
bruhanje slabost
Vomiting Nausea
zvišana telesna temperatura mestu aplikacije
In view of the mechanism of action of Fasturtec, an overdose will lead to low or undetectable plasma uric acid concentrations and increased production of hydrogen peroxide.
Glede na mehanizem delovanja Fasturteca, bi preveliko odmerjanje povzročilo nizke do nedoločljivo nizke koncentracije sečne kisline v plazmi in povečano nastajanje vodikovega peroksida.
Thus patients suspected of receiving an overdose should be monitored for haemolysis, and general supportive measures should be initiated as no specific antidote for Fasturtec has been identified.
Za Fasturtec ne obstaja specifičen protistrup, zato morate uvesti splošne podporne ukrepe.
Detoxifying agents for antineoplastic treatment, ATC code:
Zdravila za zaščito organizma pred toksičnostjo citostatikov, oznaka ATC:
4 levels of uric acid subsequent to the lysis of large numbers of malignant cells and during cytoreductive chemotherapy may lead to impairment of renal function and renal failure resulting from the precipitation of crystals of uric acid in renal tubules.
Akutno povečanje koncentracije sečne kisline v plazmi, do katerega pride po razkroju velikega števila rakastih celic in med citoreduktivno kemoterapijo, lahko povzroči okvaro ledvične funkcije in odpoved ledvic zaradi obarjanja kristalov sečne kisline v ledvičnih tubulih.
The increased of hydrogen peroxide over ambient levels can be eliminated by endogenous antioxidants and the only increased risk is for haemolysis in G6PD deficient and inherited anaemia patients.
Povečano tveganje hemolize obstaja le pri bolnikih s pomanjkanjem glukoza- 6- fosfat dehidrogenaze in bolnikih s prirojeno anemijo.
In healthy volunteers, a marked dose-related decrease in plasma uric acid levels was observed across the dose range 0.05 mg/ kg to 0.20 mg/ kg of Fasturtec.
Pri zdravih prostovoljcih so opazili izrazito odvisnost zmanjšanja ravni sečne kisline v plazmi od odmerka, pri odmerkih od 0, 05 mg/ kg do 0, 20 mg/ kg Fasturteca.
A randomised comparative phase III study, using the recommended dose, showed a significantly more rapid onset of action of Fasturtec in comparison with allopurinol.
V primerjalni randomizirani študiji tretje faze, pri kateri so uporabili priporočene odmerke, so opazili bistveno hitrejši pričetek učinka pri Fasturecu kot pri alopurinolu.
At 4 hours post first dose, there was a significant difference in the mean percentage change from baseline plasma uric acid concentration (p < 0.0001) in the Fasturtec group (-86.0%) compared to that for the allopurinol group (-12.1%).
4 ure po prvem odmerku je obstajala statistično značilna razlika v spremembi srednje vrednosti izhodiščne koncentracije sečne kisline v plazmi (p < 0, 0001) med skupinama bolnikov, ki so prejemali Fasturtec (- 86, 0%) in alopurinol (- 12, 1%).
Time to first confirmation of normal levels of uric acid in hyperuricaemic patients is four hours for Fasturtec and 24 hours for allopurinol.
Čas, potreben za doseganje normalnih ravni sečne kisline pri bolnikih s hiperurikemijo, je pri Fasturecu 4 ure in pri alopurinolu 24 ur.
In turn, this allows efficient excretion of the serum phosphate load preventing further deterioration of renal function from calcium/ phosphorus precipitation.
To omogoča učinkovito izločanje serumskih fosfatov, kar preprečuje nadaljnje poslabšanje delovanja ledvic zaradi obarjanja kalcija in fosforja.
Paediatric patients In pivotal clinical studies, 246 patients (< 18 years) were treated with rasburicase at doses of 0.15 mg/ kg/ day or 0.20 mg/ kg/ day for 1 to 8 days (mainly 5 to 7 days).
Pediatrični bolniki V ključnih kliničnih študijah so 246 bolnikov (< 18 let) zdravili z razburikazo v odmerkih 0, 15 mg/ kg/ dan ali 0, 20 mg/ kg/ dan od 1 do 8 dni (v glavnem od 5 do 7 dni).
Efficacy results on 229 evaluable patients showed an overall response rate (normalization of plasma uric acid levels) of 96.1%.
Rezultati o učinkovitosti pri 229 ocenljivih bolnikih so pokazali celoten delež odziva (normalizacijo koncentracije sečne kisline v plazmi) 96, 1%.
In long term safety studies, an analysis of data from 867 patients (< 18 years) treated with rasburicase at 0.20 mg/ kg/ day for 1 to 24 days (mainly 1 to 4 days) showed consistent findings with pivotal clinical studies in terms of efficacy and safety.
V dolgoročnih študijah varnosti so se rezultati o učinkovitosti in varnosti iz analize podatkov 867 bolnikov (< 18 let), ki so dobivali razburikazo v odmerku 0, 20 mg/ kg/ dan od 1 do 24 dni (v glavnem od 1 do 4 dni), skladali z izsledki ključnih kliničnih študij.
After infusion of rasburicase at a dose of 0.20 mg/ kg/ day, steady state is achieved at day 2 - 3.
Po infuziji razburikaze v odmerku 0, 20 mg/ kg/ dan se vzpostavi stanje dinamičnega ravnovesja 2. - 3. dan.
No unexpected accumulation of rasburicase was observed.
Niso opazili nepričakovanega kopičenja razburikaze.
In patients, the volume of distribution ranged from 110 - 127 ml/ kg, which is comparable to the physiological vascular volume.
Volumen porazdelitve pri bolnikih je bil 110 – 127 ml/ kg, kar je primerljivo z normalnim žilnim volumnom.
19 hours.
Očistek razburikaze je bil približno 3, 5 ml/ h/ kg in razpolovni čas izločanja je bil približno 19 ur.
The patients included in the pharmacokinetic studies were mainly children and adolescents.
Bolniki, ki so sodelovali pri farmakokinetičnih študijah, so bili večinoma otroci in mladostniki.
35%) in children and adolescents compared to adults, resulting in a lower systemic exposure.
Na osnovi teh omejenih podatkov kaže, da je očistek pri otrocih in mladostnikih v primerjavi z odraslimi povečan za približno 35%, kar rezultira v nižji sistemski izpostavljenosti.
Rasburicase is a protein, and therefore:
Razburikaza je beljakovina, zato:
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.
1) ne pričakujemo, da se bo vezala na beljakovine, 2) pričakujemo, da se bo metabolno razkrajala po isti poti kot ostale beljakovine, tj. s hidrolizo peptidov in 3) ni verjetno, da bi prišlo do interakcij z drugimi zdravili.
The interpretation of the non-clinical studies is hampered due to the presence of endogenous urate oxidase in standard animal models.
Rezultate predkliničnih študij je težko tolmačiti zaradi prisotnosti endogene urat- oksidaze pri standardnih živalskih modelih.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Tega zdravila ne smete mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6. 6.
However, the in-use stability has been demonstrated for 24 hours between +2 °C and 8 °C.
Kljub temu so dokazali, da je pripravljena raztopina stabilna 24 ur pri temperaturi med 2 °C in 8 °C.
Powder in vial: store in a refrigerator (2 °C - 8 °C).
Shranjujte v hladilniku (2 °C – 8 °C).
For storage conditions of the reconstituted or the diluted medicinal product, see section 6.3.
Za pogoje shranjevanja rekonstituiranega ali redčenega zdravila glejte poglavje 6. 3.
3 vials of 1.5 mg rasburicase and 3 ampoules of 1 ml solvent.
3 viale po 1, 5 mg razburikaze in 3 ampule po 1 ml vehikla.
The powder is supplied in 3 ml clear glass (type I) vial with a rubber stopper and the solvent in a 2 ml clear glass (type I) ampoule.
Vehikel je pakiran v prozorne steklene ampule (tipa I) s prostornino 2 ml.
1 vial of 7.5 mg rasburicase and 1 ampoule of 5 ml solvent.
6 1 vialo po 7, 5 mg razburikaze in 1 ampulo s 5 ml vehikla.
The powder is supplied in 10 ml clear glass (type I) vial with a rubber stopper and the solvent in a 5 ml clear glass (type I) ampoule.
Vehikel je pakiran v prozorne steklene ampule (tipa I) s prostornino 5 ml.
6 6.6 Special precautions for disposal and other handling
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Rasburicase must be reconstituted with the entire volume of the supplied solvent ampoule (1.5 mg rasburicase vial to be reconstituted with the 1 ml solvent ampoule; 7.5 mg rasburicase vial to be reconstituted with the 5 ml solvent ampoule).
Razburikazo morate rekonstituirati s celotnim volumnom priložene ampule z vehiklom (1, 5 mg vialo razburikaze morate rekonstituirati z 1 ml ampulo vehikla; 7, 5 mg vialo razburikaze morate rekonstituirati s 5 ml ampulo vehikla).
Reconstitution results in a solution with a concentration of 1.5 mg/ ml rasburicase to be further diluted with sodium chloride 9 mg/ ml (0.9%) intravenous solution.
Z rekonstitucijo dobite raztopino s koncentracijo 1, 5 mg/ ml razburikaze, ki jo nato razredčite z raztopino natrijevega klorida za intravensko uporabo, 9 mg/ ml (0, 9% raztopina natrijevega klorida).
Add the content of one ampoule of solvent to one vial containing rasburicase and mix by swirling very gently under controlled and validated aseptic conditions.
Raztopino pripravljajte v validiranih aseptičnih pogojih.
For single-use only, any unused solution should be discarded.
Neuporabljeno raztopino zavrzite.
The required volume of the reconstituted solution, taken from one or more vials, is to be further diluted with sodium chloride 9 mg/ ml (0.9%) solution to make a total volume of 50 ml.
Potreben volumen rekonstituirane raztopine, ki ste jo dobili iz ene ali več vial, morate razredčiti z 0, 9% raztopino natrijevega klorida, tako da dobite skupni volumen 50 ml.
If it is necessary to monitor a patient’ s uric acid level, a strict sample-handling procedure must be followed to minimise ex vivo degradation of the analyte.
Če morate nadzorovati raven sečne kisline pri bolniku, morate strogo upoštevati navodila za ravnanje z vzorci, da bi na najmanjšo mero zmanjšali možnosti ex vivo razkroja vzorca za analizo.
Samples must be immersed in an ice/ water bath.
Vzorce morate potopiti v kopel z ledom in vodo.
Plasma samples should immediately be prepared by centrifugation in a pre-cooled centrifuge (4 °C).
Vzorce plazme morate takoj pripraviti s centrifugiranjem v vnaprej ohlajeni centrifugi (4 °C).
Finally, plasma must be maintained in an ice/ water bath and analysed for uric acid within 4 hours.
Plazmo morate hraniti v kopeli z ledom in vodo ter analizirati količino sečne kisline v 4 urah.
sanofi-aventis 174, avenue de France F - 75013 Paris France
sanofi- aventis 174, avenue de France F - 75013 Paris Francija
23 February 2001 Date of latest renewal:
23. februar 2001 Datum zadnjega podaljšanja dovoljenja za promet:
Sanofi Chimie Route d’ Avignon 30390 Aramon France
sanofi- aventis recherche & développement Quartier Grande Borde La Pyrénéenne BP 37202 31672 Labège Cedex Francija
Glaxo Wellcome Production 1, rue de l’ Abbaye 76960 Notre Dame de Bondeville France
Glaxo Wellcome Production 1 rue de l’ Abbaye 76960 Notre Dame de Bondeville Francija
Fasturtec 1.5 mg/ ml powder and solvent for concentrate for solution for infusion
Fasturtec 1, 5 mg/ ml prašek in vehikel za koncentrat za raztopino za infundiranje
rasburicase
razburikaza
rasburicase 1.5 mg/ 1 ml
razburikaza 1, 5 mg/ 1 ml
rasburicase produced by genetechnology in Saccharomyces cerevisiae strain
razburikaza, ki jo je v gensko- tehnološkem postopku proizvedel sev kvasovke Saccharomyces cerevisiae
3 vials and 3 ampoules
3 viale in 3 ampule
METHODS AND ROUTE(S) OF ADMINISTRATION
POSTOPEK IN POT( I) UPORABE ZDRAVILA
Reconstitution required with the entire contents of the 1 ml solvent ampoule
Za rekonstitucijo morate porabiti celotno vsebino 1 ml ampule z vehiklom
14 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 3 POWDER VIALS AND 3 SOLVENT AMPOULES
14 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
15 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
15 PODATKI, KI OVOJNINAH
POWDER/ VIAL
NAVEDENI NA
Fasturtec 1.5 mg/ ml powder for concentrate for solution for infusion rasburicase Intravenous use
Fasturtec 1, 5 mg/ ml prašek za koncentrat za raztopino za infundiranje razburikaza Intravenska uporaba
16 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
16 PODATKI, KI OVOJNINAH
SOLVENT/ AMPOULE
VEHIKEL/ AMPULA
Solvent for rasburicase 1.5 mg
Vehikel za razburikazo 1, 5 mg
Fasturtec 1.5 mg/ ml powder and solvent for concentrate for solution for infusion
Fasturtec 1, 5 mg/ ml prašek in vehikel za koncentrat za raztopino zainfundiranje
rasburicase 7.5 mg/ 5 ml
razburikaza 7, 5 mg/ 5 ml
Reconstitution required with the entire contents of the 5 ml solvent ampoule
Za rekonstitucijo morate porabiti celotno vsebino 5 ml ampule z vehiklom
19 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
19 PODATKI, KI OVOJNINAH
20 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
20 PODATKI, KI OVOJNINAH
Solvent for rasburicase 7.5 mg
Vehikel za razburikazo 7, 5 mg
Fasturtec 1.5 mg/ ml powder and solvent for concentrate for solution for infusion rasburicase
Fasturtec 1, 5 mg/ ml prašek in vehikel za koncentrat za raztopino za infundiranje razburikaza
- If you have any further questions, ask your doctor, nurse or hospital pharmacist.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom, medicinsko sestro ali z bolnišničnim
please tell your doctor, nurse or hospital pharmacist.
omenjen v tem navodilu, obvestite svojega zdravnika, medicinsko sestro ali bolnišničnega farmacevta.
What Fasturtec is and what it is used for 2.
Kaj je zdravilo Fasturtec in za kaj ga uporabljamo 2.
Before you use Fasturtec 3.
Kaj morate vedeti, preden boste uporabili zdravilo Fasturtec 3.
How to use Fasturtec 4.
Kako uporabljati zdravilo Fasturtec 4.
How to store Fasturtec 6.
Shranjevanje zdravila Fasturtec 6.
WHAT FASTURTEC IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO FASTURTEC IN ZA KAJ GA UPORABLJAMO
Rasburicase is used to treat or prevent high blood levels of uric acid from occurring in patients with disorders of the blood cells (haematological diseases) who are about to receive or are receiving chemotherapy treatment.
Razburikazo uporabljamo za zdravljenje ali preprečevanje visoke ravni sečne kisline v krvi, ki se pojavi pri bolnikih z boleznimi krvnih celic (hematološka obolenja), ki bodo ali so že pričeli s kemoterapijo.
BEFORE YOU USE FASTURTEC
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO FASTURTEC
Do not use Fasturtec if you:
Ne uporabljajte zdravila Fasturtec, če ste:
- are allergic (hypersensitive) to rasburicase, other uricases or any of the other ingredients of
- alergični na (preobčutljivi za) razburikazo, druge urikaze ali katerokoli sestavino zdravila
- have a history of haemolytic anaemia (an illness caused by red blood cells being abnormally
- imeli ali imate hemolitično anemijo (bolezen, ki nastane zaradi nenormalne razgradnje rdečih
broken down).
krvnih celic).
Take special care with Fasturtec if you:
Bodite posebno pozorni pri uporabi zdravila Fasturtec, če ste:
- have a history of any kind of allergy.
- v preteklosti že kdaj imeli katerokoli alergijo.
Tell your doctor if you have ever had any allergic type reactions due to other medicines as Fasturtec can cause allergic-type reactions, including severe cases.
Obvestite svojega zdravnika, če ste kadarkoli ob uporabi drugih zdravil imeli kakršnokoli alergijsko reakcijo saj lahko tudi Fasturtec izzove alergijske reakcije, vključno s hudimi primeri.
It is not known whether the chance of developing an allergic reaction is increased if treatment with Fasturtec is repeated.
Ni znano, če je možnost razvoja alergijskih reakcij povečana, če se zdravljenje s Fasturtecom ponovi.
Using other medicines Please tell your doctor if you are taking, or have recently taken, any other medicines, including
Uporaba drugih zdravil
23 medicines obtained without a prescription.
23 Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Pregnancy and breast feeding Tell your doctor if you are, or think you may be pregnant, or if you are breast-feeding.
Nosečnost in dojenje Obvestite svojega zdravnika če ste ali mislite, da ste noseči ali čedojite.
HOW TO USE FASTURTEC
KAKO UPORABLJATI ZDRAVILO FASTURTEC
The recommended dose is 0.20 mg per kg of body weight per day in both children and adults.
Priporočen odmerek je 0, 20 mg na kg telesne mase na dan, tako pri otrocih, kot pri odraslih.
If you use more Fasturtec than you should If it does occur, the doctor will closely monitor the effects on your red blood cells and treat any symptoms that follow.
Če ste uporabili večji odmerek zdravila Fasturtec, kot bi smeli V primeru, da se to zgodi, bo zdravnik pazljivo nadziral vpliv zdravila na vaše rdeče krvne celice in zdravil morebitne simptome.
If you have any further questions on the use of this product, ask your doctor, nurse or hospital pharmacist.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, medicinsko sestro ali bolnišničnim farmacevtom.
Like all medicines, Fasturtec can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi Fasturtec neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
- a swelling of the face, lips, tongue or other part of your body
- zatekanje obraza, ustnic, jezika ali drugih delov telesa
- a shortness of breath, wheezing or breathing problems
- kratko sapo, sopenje ali težave pri dihanju
- a rash, itching or hives
- izpuščaj, srbečico ali koprivnico
tell your doctor, nurse or hospital pharmacist immediately as these may be signs of a serious allergic reaction (anaphylaxis).
to nemudoma povejte zdravniku, medicinski sestri ali bolnišničnemu farmacevtu, saj so to lahko znaki hude alergijske reakcije (anafilaksa).
These are rare (affecting between 1 in 1,000 and 1 in 10,000 patients).
Ti znaki so redki (prizadenejo manj kot 1 od 1. 000 in več kot 1 od 10. 000 bolnikov).
Common side effects (affecting between 1 in 10 and 1 in 100 patients):
Pogosti neželeni učinki (prizadenejo manj kot 1 od 10 in več kot 1 od 100 bolnikov):
- high fever
- visoka vročina
- allergic reactions, mainly rashes and urticaria.
- alergijske reakcije, večinoma izpuščaji in koprivnica.
Uncommon side effects (affecting between 1 in 100 and 1 in 1,000 patients):
Občasni neželeni učinki (prizadenejo manj kot 1 od 100 in več kot 1 od 1. 000 bolnikov):
- severe allergic reaction, such as low blood pressure (hypotension) and wheezing or difficulty in
- hude alergijske reakcije, kot so znižan krvni pritisk (hipotenzija) in sopenje ali težave pri dihanju
breathing (bronchospasm)
(bronhospazem)
- severe diarrhoea
- huda driska
- severe vomiting
- hudo bruhanje
- severe nausea
- huda slabost
- severe headache
- močan glavobol
- blood disorders such as a disorder of the blood in which red blood cells are abnormally broken
- krvne bolezni, kot je bolezen krvi, pri kateri pride do nenormalne razgradnje rdečih krvnih celic
down (haemolysis) or abnormal blood pigment levels (methaemoglobinaemia).
(hemoliza) ali nenormalnih vrednosti krvnih barvil (methemoglobinemija).
24 Rare (affecting between 1 in 1,000 and 1 in 10,000 patients):
Redki (prizadenejo manj kot 1 od 1. 000 in več kot 1 od 10. 000 bolnikov):
- runny or blocked nose, sneezing, facial pressure or pain (rhinitis).
- izcedek iz nosu ali zamašen nos, kihanje, pritisk na obraz ali bolečina (rinitis).
If you notice any of these, tell your doctor, nurse or hospital pharmacist.
Če opazite katerikoli opisan neželeni učinek, nemudoma obvestite svojega zdravnika, medicinsko sestro ali bolnišničnega farmacevta.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or hospital pharmacist.
Če katerikoli neželen učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika, medicinsko sestro ali bolnišničnega farmacevta..
HOW TO STORE FASTURTEC
SHRANJEVANJE ZDRAVILA FASTURTEC
Do not use Fasturtec after the expiry date which is stated on the carton.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
Do not use Fasturtec if you notice that the solution is unclear and/ or contains particles.
Ne uporabljajte zdravila Fasturtec, če opazite, da raztopina ni bistra ali da vsebuje delce.
- The active substance is rasburicase 1.5 mg/ ml.
Zdravilna učinkovina je razburikaza 1. 5 mg/ ml.
Rasburicase is produced by genetechnology in a
Razburikazo proizvaja mikroorganizem po imenu Saccharomyces cerevisiae v gensko- tehnološkem postopku.
microorganism named Saccharomyces cerevisiae.
-
- The other ingredients of the powder are: alanine, mannitol, disodium phosphate dodecahydrate,
Pomožne snovi praška so: alanin, manitol, natrijev hidrogenfosfat dodekahidrat, natrijev hidrogenfosfat dihidrat, natrijev dihidrogenfosfat dihidrat.
disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate.
-
- The other ingredients of the solvent are: poloxamer 188, water for injection.
Pomožne snovi vehikla so: poloksamer 188, voda za injekcije.
Fasturtec is provided as a powder and solvent for concentrate for solution for infusion.
Fasturtec je na voljo kot prašek in vehikel za koncentrat za raztopino za infundiranje.
Pack of 3 vials of 1.5 mg rasburicase and 3 ampoules of 1 ml solvent.
Pakiranje 3 vial, ki vsebujejo 1, 5 mg razburikaze in 3 ampul, ki vsebujejo 1 ml vehikla.
Pack of 1 vial of 7.5 mg rasburicase and 1 ampoule of 5 ml solvent.
Pakiranje 1 viale, ki vsebuje 7, 5 mg razburikaze in 1 ampule, ki vsebuje 5 ml vehikla.
The powder is supplied in 10 ml clear glass vial with a rubber stopper and the solvent in a 5 ml clear glass ampoule.
Prašek je pakiran v 10 ml viali iz prozornega stekla z gumijastim zamaškom in vehikel v 5 ml ampuli iz prozornega stekla.
sanofi-aventis 174, avenue de France F-75013 Paris France
Imetnik dovoljenja za promet z zdravilom sanofi- aventis 174, avenue de France F- 75013 Paris Francija
Glaxo Wellcome Production 1, rue de l’ Abbaye F-76960 Notre Dame de Bondeville France
25 Izdelovalec Glaxo Wellcome Production 1, rue de l’ Abbaye F- 76960 Notre Dame de Bondeville Francija
Luxembourg/ Luxemburg sanofi-aventis Belgium Tél/ Tel: +32 (0)2 710 54 00 (Belgique/ Belgien)
Luxembourg/ Luxemburg België / Belgique/ Belgien sanofi- aventis Belgium sanofi- aventis Belgium Tél/ Tel: +32 (0) 2 710 54 00 (Belgique/ Belgien) Tél/ Tel: +32 (0) 2 710 54 00
France sanofi-aventis France Tél:
România France sanofi- aventis România S. R. L. sanofi- aventis france Tel: +40 (0) 21 317 31 36 Tél:
România sanofi-aventis România S. R. L.
Slovenija Ireland sanofi- aventis d. o. o. sanofi- aventis Ireland Ltd.
Tel: +40 (0) 21 317 31 36
Tel: +386 1 560 48 00 Tel: +353 (0) 1 403 56 00
Ireland sanofi-aventis Ireland Ltd.
Vistor hf.
Tel: +353 (0) 1 403 56 00
Tel: +421 2 57 103 777 Sími: +354 535 7000
Slovenija sanofi-aventis d. o. o.
Italia sanofi- aventis S. p. A.
Tel: +386 1 560 48 00
Suomi/ Finland sanofi- aventis Oy
This leaflet was last approved in {MM/ YYYY}
Navodilo je bilo odobreno {datum}
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu.