natgillin/translations-raw huggingface dataset:
Your doctor or nurse will give you Faslodex as a slow intramuscular injection into your buttock.
Vaš zdravnik ali medicinska sestra vam bo zdravilo Faslodex počasi injiciral v mišico zadnjice.
Like all medicines, Faslodex can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Faslodex neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
These side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
Zelo pogosti: pojavijo se pri več kot 1 od 10 bolnikov Pogosti: pojavijo se pri 1 do 10 bolnikih od 100 bolnikov Občasni: pojavijo se pri 1 do 10 bolnikih od 1. 000 bolnikov Redki: pojavijo se pri 1 do 10 bolnikih od 10. 000 bolnikov Zelo redki: pojavijo se pri manj kot 1 bolniku od 10. 000 bolnikov Neznana pogostnost: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti
Very common side effects • Hot flushes
• navali vročine.
Common side effects • Injection site reactions, such as pain and/ or inflammation • Headache • Weakness and tiredness • Nausea (feeling sick), vomiting, diarrhoea or loss of appetite • Rash • Urinary tract infections • Back pain • Increased risk of blood clots • Abnormal levels of liver enzymes (in blood tests)
• reakcije na mestu injiciranja, kot sta bolečina in/ ali vnetje, • glavobol, • občutek šibkosti in utrujenost, • navzeja (občutek slabosti), bruhanje, driska ali izguba apetita, • izpuščaj, • okužbe sečil, • bolečine v križu, • povečano tveganje za nastanek krvnih strdkov, • nepravilni nivoji jetrnih encimov (pri krvnih preiskavah).
Uncommon side effects • Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/ or throat • Vaginal bleeding, thick, whitish discharge and candidiasis (infection)
Občasni neželeni učinki • alergijske (preobčutljivostne) reakcije, vključno z otekanjem obraza, ustnic, jezika in/ ali grla, • krvavitve iz nožnice, gost, belkast izcedek iz nožnice in kandidiaza (glivična okužba nožnice), •
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 pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, o tem čim prej obvestite svojega zdravnika, medicinsko sestro ali farmacevta.
HOW TO STORE FASLODEX
SHRANJEVANJE ZDRAVILA FASLODEX
Store in a refrigerator (2°C – 8°C) Keep the pre-filled syringe in the original package, in order to protect from light.
Napolnjeno injekcijsko brizgo shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
Do not use after the expiry date which is stated on the carton or syringe label after the abbreviation EXP.
21 Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na injekcijski brizgi poleg za oznake Upor. do:.
Your health care professional will be responsible for the correct storage, use and disposal of Faslodex.
Vaš zdravnik bo odgovoren za pravilno shranjevanje, uporabo in odstranjevanje zdravila Faslodex.
What Faslodex contains
Kaj vsebuje zdravilo Faslodex
- The active substance is fulvestrant.
- Zdravilna učinkovina je fulvestrant.
Each pre-filled syringe (5 ml) contains 250 mg fulvestrant.
Ena napolnjena injekcijska brizga (5 ml) vsebuje 250 mg
- The other ingredients are ethanol (96 per cent), benzyl alcohol, benzyl benzoate and castor oil.
etanol, 96 odstotni, benzilalkohol, benzilbenzoat in ricinusovo olje.
What Faslodex looks like and contents of the pack Faslodex is a clear, colourless to yellow, viscous solution in a pre-filled syringe fitted with a tamper-evident closure, containing 5 ml solution for injection A safety needle (SafetyGlide) for connection to the barrel is also provided.
Priložena je tudi varnostna igla (SafetyGlide) za povezavo z valjem.
Marketing Authorisation Holder AstraZeneca UK Limited Alderley Park Macclesfield Cheshire SK10 4TG United Kingdom
AstraZeneca UK Limited Alderley Park Macclesfield Cheshire SK10 4TG Velika Britanija
Manufacturer AstraZeneca UK Limited Silk Road Business Park Macclesfield Cheshire SK10 2NA United Kingdom
AstraZeneca UK Limited Silk Road Business Park, Macclesfield Cheshire SK10 2NA Velika Britanija
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Za vse morebitne nadaljne informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
България ТП AstraZeneca UK Limited Тел.: +359 2 971 25 33 Danmark AstraZeneca A/ S Tel: +45 43 66 64 62
Danmark AstraZeneca A/ S Tel: + 45 43 66 64 62
Tel: +372 6549 600
Eesti Ελλάδα AstraZeneca Tel: +372 6549 600
20 Ελλάδα AstraZeneca A. E.
AstraZeneca A. E.
Tél: + 33 1 41 29 40 00
AstraZeneca Tél: + 33 1 41 29 40 00
Norge AstraZeneca AS Tel: +47 21 00 64 00
Norge Österreich AstraZeneca AS Tel: +47 21 00 64 00
Tel: +43 1 711 31 310
AstraZeneca Österreich GmbH Tel: +43 1 711 31 310
Tel.: + 48 22 874 35 00
Polska AstraZeneca Pharma Poland Sp. z o. o. tel.: + 48 22 874 35 00
Tel: +351 21 434 61 00
P- 2745- 663 Barcarena Tel: +351 21 434 61 00
21 This leaflet was last approved on
Navodilo je bilo odobreno
The following information is intended for healthcare professionals only:
23 Naslednje informacije so namenjene samo zdravstvenemu osebju:
Faslodex 250 mg/ 5 ml solution for injection.
Faslodex 250 mg/ 5 ml raztopina za injiciranje.
Pre-filled syringe.
Napolnjena injekcijska brizga.
Remove glass syringe barrel from tray and check that it is not damaged.
Odstranite stekleni valj injekcijske brizge iz podstavka in preverite, da ni poškodovan.
SafetyGlide Information from Becton Dickinson
Informacije Becton Dickinsona o SafetyGlide
WARNING: - Do not autoclave safety needle before use.
OPOZORILO: - Pred uporabo ne avtoklavirajte varnostne igle.
Hands must remain behind the needle at all times during use and disposal.
Med uporabo in odstranjevanjem morajo biti roke ves čas za iglo.
Directions for Use of safety needle
Navodila za uporabo varnostne igle
Peel apart packaging of the safety needle, break the seal of the white plastic cover on the syringe Luer connector and attach the safety needle to the Luer Lock of the syringe by twisting.
Odstranite ovojnino z varnostne igle, prelomite pečat belega plastičnega pokrovčka na Luerjevem spojniku injekcijske brizge in z obračanjem pritrdite varnostno iglo k zaporki Luer na injekcijski brizgi.
Administer injection following instructions above.
Injicirajte v skladu z navodili zgoraj.
Activation of the protective mechanism may cause minimal splatter of fluid that may remain on the needle after injection.
Aktivacija zaščitnega mehanizma lahko povzroči manjši brizgljaj tekočine, ki lahko ostane na igli po injiciranju.
Any unused product or waste material should be disposed of in accordance with local requirements.
24 Slika 1
22 23
Slika 3
Fasturtec is a medicine containing the active substance rasburicase.
Fasturtec je zdravilo, ki vsebuje zdravilno učinkovino razburikaze.
It is available as a powder and solvent, which are made up into a solution for infusion (drip into a vein) with 1.5 mg rasburicase in 1 ml.
Na voljo je v obliki praška in vehikla, iz katerih se pripravi raztopina za infundiranje (kapljanje v veno) z 1, 5 mg razburikaze v 1 ml.
Fasturtec is used to treat and prevent acute (sudden) hyperuricaemia (increased levels of uric acid in the blood), in order to prevent kidney failure.
Zdravilo Fasturtec se uporablja za zdravljenje in preprečevanje akutne (nenadne) hiperurikemije (povečane koncentracije sečne kisline v krvi) z namenom preprečevanja odpovedi delovanja ledvic.
Fasturtec is used in patients with haematological malignancies (blood cancers) who are at risk of a rapid tumour lysis (breakdown) or shrinkage at the start of chemotherapy (medicines given for cancer).
Zdravilo Fasturtec se uporablja pri bolnikih s hematološkimi malignimi obolenji (krvnimi raki), pri katerih obstaja tveganje za hiter razkroj tumorja ali njegovo zmanjšanje po pričetku kemoterapije (zdravila, ki se dajejo za zdravljenje rakavih obolenj).
Fasturtec treatment should be supervised by a doctor who has been trained in the chemotherapy of haematological malignancies.
Zdravljenje z zdravilom Fasturtec mora nadzorovati zdravnik, ki je usposobljen za zdravljenje hematoloških malignih obolenj s kemoterapijo.
Fasturtec is given at the start of chemotherapy.
Zdravilo Fasturtec se daje na začetku kemoterapije.
The recommended dose is 0.20 mg per kilogram body weight in both children and adults given as a daily infusion for up to seven days.
Tako pri odraslih kot pri otrocih priporočeni odmerek znaša 0, 2 mg na kilogram telesne mase, daje pa se ga v dnevni infuziji v obdobju do sedem dni.
The duration of treatment is adjusted depending on the patient ’ s uricaemia (blood levels of uric acid) and the doctor's judgment.
Trajanje zdravljenja se prilagodi glede na izraženost urikemije (koncentracije sečne kisline v krvi) in v skladu s presojo zdravnika.
The infusion should last 30 minutes.
Infundiranje mora trajati 30 minut.
When patients with blood cancers start chemotherapy, they are at risk of developing hyperuricaemia.
Ko bolniki s krvnim rakom začnejo s kemoterapijo, so izpostavljeni tveganju, da se pri njih razvije hiperurikemija.
This is because the chemotherapy destroys the tumour cells, breaking down the genetic material in the cells, and leading to a sharp increase in the levels of uric acid in the blood.
Do tega pride zato, ker kemoterapija uniči tumorske celice, pri čemer pride do razpada genetskega materiala v celicah, to pa ima za posledico veliko povečanje koncentracij sečne kisline v krvi.
The body cannot get rid of too much uric acid, so it can accumulate in the kidneys, causing them to fail (stop working).
Telo se ne more znebiti tako velike količine sečne kisline, zato se ta kopiči v ledvicah in povzroči njihovo odpoved (prenehanje delovanja).
The active substance in Fasturtec, rasburicase, is an enzyme called urate oxidase, which is able to transform uric acid into another chemical called allantoin.
Zdravilna učinkovina v zdravilu Fasturtec, razburikaza, je encim, imenovan urat oksidaza, ki lahko sečno kislino pretvori v drugo kemično snov, imenovano alantoin.
Allantoin can easily be excreted by the kidneys in the urine.
Alantoin ledvice brez težav izločijo s sečem.
The enzyme was originally extracted from a fungus, but in Fasturtec it is produced by a method known as ‘ recombinant DNA technology’: it is made by a yeast that has received a gene (DNA) that makes it able to produce urate oxidase.
Encim so prvotno pridobivali z ekstrakcijo iz glive, pri zdravilu Fasturtec pa se pridobiva z uporabo metode, imenovane „ tehnologija rekombinantne DNA “: pri tej metodi encim proizvaja kvasovka, ki so ji vgradili gen (DNK), ki ji omogoča tvorbo urat oksidaze.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged standard treatment for reducing uric acid levels) in one of the studies, which included 52 patients.
Dve študiji sta bili zasnovani z namenom določitve najustreznejšega odmerka za uporabo.
In this study, the main measure of effectiveness was the amount of uric acid in the blood, measured over 96 hours.
V tej študiji je bilo najpomembnejše merilo učinkovitosti količina sečne kisline v krvi, ki so jo merili 96 ur.
What benefit has Fasturtec shown during the studies?
Kakšne koristi je zdravilo Fasturtec izkazalo med raziskavami?
The dose-finding studies showed that, after 48 hours, Fasturtec at a dose of 0.20 mg/ kg reduced the uric acid levels to normal values in 95% of patients.
Študije, v katerih so skušali ugotoviti najustreznejši odmerek, so pokazale, da je po 48 urah zdravilo Fasturtec v odmerku 0, 20 mg/ kg zmanjšalo koncentracije sečne kisline na normalne vrednosti pri 95% bolnikov.
In the comparative study, Fasturtec was more effective than allopurinol: over the first 96 hours after treatment, patients treated with Fasturtec had a lower average blood level of uric acid compared that in the patients treated with allopurinol (128.1 and 328.5 mg. h/ dl, respectively).
V primerjalni študiji je bilo zdravilo Fasturtec bolj učinkovito kot alopurinol: v prvih 96 urah po zdravljenju so bolniki, ki so se zdravili z zdravilom Fasturtec, imeli nižje povprečne koncentracije sečne kisline v krvi kot pa bolniki, ki so se zdravili z alopurinolom (128, 1 oziroma 328, 5 mg. h/ dl).
The most common side effects with Fasturtec (seen in between 1 and 10 patients in 100) are allergic reactions, mainly rashes, and fever.
Najpogostejši neželeni učinki pri jemanju zdravila Fasturtec (opaženi pri 1 do 10 bolnikih izmed 100) so alergijske reakcije, predvsem izpuščaji in zvišana telesna temperatura.
Patients should be closely monitored for allergic reactions during treatment.
Pri bolnikih je treba skrbno spremljati morebiten pojav alergijskih reakcij med zdravljenjem.
For the full list of all side effects reported with Fasturtec, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Fasturtec, glejte Navodilo za uporabo.
Fasturtec should not be used in patients who are hypersensitive (allergic) to rasburicase or any of the other ingredients.
Zdravila Fasturtec se ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) razburikazo ali katero koli drugo sestavino zdravila.
Fasturtec should not be used in patients with a deficiency in glucose-6-phosphate dehydrogenase (G6PD) or other metabolic disorders known to cause haemolytic anaemia (low red blood cell counts, caused by the cells being destroyed too soon).
Zdravila Fasturtec se ne sme uporabljati pri bolnikih s pomanjkanjem glukoza- 6- fosfat dehidrogenaze (G6PD) ali z drugimi presnovnimi motnjami, za katere je znano, da povzročajo hemolitično anemijo (majhno število rdečih krvničk, ki je posledica prehitrega razpada celic).
The Committee for Medicinal products for Human Use (CHMP) decided that Fasturtec’ s benefits are greater than its risks for the treatment and prophylaxis of acute hyperuricaemia, in order to prevent acute renal failure, in patients with haematological malignancy with a high tumour burden and at risk of a rapid tumour lysis or shrinkage at initiation of chemotherapy.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Fasturtec pri zdravljenju in preventivi akutne hiperurikemije z namenom preprečevanja akutne okvare ledvic pri bolnikih s hematološkimi malignimi obolenji z visoko tumorsko obremenitvijo in s tveganjem za hiter razkroj tumorja ali njegovo zmanjšanje po pričetku kemoterapije večje od z njim povezanih tveganj.
The Committee recommended that Fasturtec be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Fasturtec odobri dovoljenje za promet.
Other information about Fasturtec:
Druge informacije o zdravilu Fasturtec:
The European Commission granted a marketing authorisation valid throughout the European Union for Fasturtec to sanofi-aventis on 23 February 2001.
Evropska komisija je dovoljenje za promet z zdravilom Fasturtec, veljavno po vsej Evropski uniji, odobrila družbi Sanofi- Aventis dne 23. februarja 2001.
The marketing authorisation was renewed on 23 February 2006.
Dovoljenje za promet z zdravilom je bilo podaljšano 23. februarja 2006.
The full EPAR for Fasturtec is available here.
Celotno Evropsko javno poročilo o oceni (EPAR) za zdravilo Fasturtec je na voljo tukaj.
©EMEA 2007
Povzetek je bil nazadnje posodobljen 08- 2007.
2/ 2
2/ 2 ©EMEA 2007
EU Number EU/ 1/ 00/ 170/ 001
EU/ 1/ 00/ 170/ 001 Fasturtec
Pharmaceutical form Powder and solvent for solution for infusion
Prašek in vehikel za koncentrat Intravenska uporaba za raztopino za infundiranje
Packaging vial (glass); ampoule (glass)
viala (steklo); ampula (steklo)
Content powder:
prašek:
1.5 mg; solvent:
1, 5 mg per viala 3 viale 3 ampule vehikel:
1 ml (1.5 mg/ ml)
1 ml per ampula
EU/ 1/ 00/ 170/ 002
EU/ 1/ 00/ 170/ 002 Fasturtec
Powder and solvent for solution for infusion
Prašek in vehikel za koncentrat Intravenska uporaba za raztopino za infundiranje
vial (glass); ampoule (glass)
viala (steklo); ampula (steklo)
7.5 mg; solvent:
7, 5 mg; 1 viala 1 ampula vehikel:
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.
After reconstitution, 1 ml of Fasturtec concentrate contains 1.5 mg rasburicase.
Po rekonstituciji vsebuje 1 ml koncentrata Fasturteca 1, 5 mg razburikaze.
Fasturtec is a recombinant urate-oxidase enzyme produced by genetically modified Saccharomyces cerevisiae strain.
Fasturtec je rekombinantni encim urat- oksidaza, ki ga proizvaja gensko spremenjen sev kvasovke Saccharomyces cerevisiae.
1 mg corresponds to 18.2 EAU*.
1 mg ustreza 18, 2 EAU *.
*One enzyme activity unit (EAU) corresponds to the enzyme activity that converts 1 µmol of uric acid into allantoin per minute under the operating conditions described: +30 °C ± 1 °C TEA pH 8.9 buffer.
* Ena enota aktivnosti encima (Enzyme Activity Unit - EAU) ustreza encimski aktivnosti, ki spremeni 1 µmol sečne kisline v alantoin na minuto pri določenih pogojih: +30 °C ± 1 °C pufra TEA, pH 8, 9.
Therapeutic indications
4. 1 Terapevtske indikacije
Treatment and prophylaxis of acute hyperuricaemia, in order to prevent acute renal failure, in patients with haematological malignancy with a high tumour burden and at risk of a rapid tumour lysis or shrinkage at initiation of chemotherapy.
Zdravljenje in preventiva akutne hiperurikemije z namenom preprečevanja akutne okvare ledvic pri bolnikih s hematološkimi malignimi obolenji z visoko tumorsko obremenitvijo in s tveganjem za hiter razkroj tumorja ali njegovo zmanjšanje po pričetku kemoterapije.
Posology and method of administration
4. 2 Odmerjanje in način uporabe
Fasturtec should be administered under the supervision of a physician trained in chemotherapy of haematological malignancies.
Bolnik mora jemati Fasturtec pod nadzorom zdravnika specialista za kemoterapijo hematoloških malignih obolenj.
The recommended dose for Fasturtec is 0.20 mg/ kg/ day.
Priporočen odmerek Fasturteca je 0, 20 mg/ kg/ dan.
Fasturtec is administered as a once daily 30 minute intravenous infusion in 50 ml of a sodium chloride 9 mg/ ml (0.9%) solution (see section 6.6).
Fasturtec se uporablja kot ena intravenska infuzija dnevno v trajanju 30 minut, in sicer v 50 ml 0, 9- odstotne raztopine natrijevega klorida (9 mg/ ml) (glejte poglavje 6. 6).
If use of a separate line is not possible, the line should be flushed out with saline
Če uporaba druge cevke ni možna, morate cevko po uporabi
2 solution between infusion of chemotherapeutic agents and rasburicase.
2 kemoterapevtske učinkovine in pred uporabo razburikaze izprati s fiziološko raztopino.
For instruction on use, see section 6.6.
Glejte poglavje 6. 6.
Because rasburicase may degrade uric acid in vitro, special precautions must be used during sample handling for plasma uric acid measurements, see section 6.6.
Razburikaza lahko razgradi sečno kislino in vitro, zato morate biti dodatno pozorni pri ravnanju z vzorci za meritve sečne kisline v plazmi; glejte poglavje 6. 6.
Additional information on special populations Renally or hepatically impaired patients:
Dodatne informacije o posebnih populacijah Bolniki z okvaro ledvic ali jeter:
As no adjustment is necessary, the recommended dose is 0.20 mg/ kg/ day.
Prilagoditev odmerka ni potrebna in tako je priporočeni odmerek 0, 20 mg/ kg/ dan.
Hypersensitivity to the active substance or to any of the excipients.
Preobčutljivost za zdravilno učinkovino ali katerokoli izmed pomožnih snovi.
G6PD deficiency and other cellular metabolic disorders known to cause haemolytic anaemia.
Pomanjkanje glukoza- 6- fosfat dehidrogenaze in vse ostale okvare celičnega metabolizma, ki povzročajo hemolitično anemijo.
Rasburicase like other proteins, has the potential to induce allergic responses in humans.
Tako kot drugi proteini, tudi razburikaza lahko povzroči alergijske reakcije pri človeku.
Clinical experience with Fasturtec demonstrates that patients should be closely monitored for the onset of allergic-type undesirable effects, especially severe hypersensitivity reactions including anaphylaxis (see section 4.8).
Klinične izkušnje s Fasturtecom kažejo, da morate bolnike pozorno nadzorovati, da bi opazili začetek alergijskih neželenih učinkov, zlasti hudih preobčutljivostnih reakcij, vključno z anafilakso (glejte poglavje 4. 8).
In such cases, treatment should immediately and permanently be discontinued and appropriate therapy initiated.
V takih primerih morate takoj prekiniti zdravljenje s Fasturtecom in začeti z ustreznim zdravljenjem alergijskih reakcij.
Fasturtec should immediately and permanently be discontinued in patients having developed methaemoglobinaemia, and appropriate measures initiated (see section 4.8).
Pri bolnikih, pri katerih se razvije methemoglobinemija, morate takoj ukiniti zdravljenje in uporabiti ustrezne ukrepe (glejte poglavje 4. 8).
In such case, treatment should immediately and permanently be discontinued and appropriate measures initiated (see section 4.8).
V takih primerih morate takoj ukiniti zdravljenje s Fasturtecom in ustrezno zdraviti neželene učinke (glejte poglavje 4. 8).
Administration of Fasturtec reduces the uric acid levels to below normal levels and by this mechanism reduces the chance of development of renal failure due to precipitation of uric acid crystals in renal tubules as a consequence of hyperuricaemia.
Uporaba Fasturteca zmanjša raven sečne kisline pod normalne vrednosti in na ta način zmanjša možnost razvoja okvare ledvic, do katere bi prišlo zaradi prisotnosti kristalov sečne kisline v ledvičnih tubulih kot posledica hiperurikemije.
Fasturtec has not been investigated in the patients with hyperuricemia in the context of myeloproliferative disorders.
Pri bolnikih s hiperurikemijo kot posledico mieloproliferativnih obolenj niso raziskovali vloge Fasturteca.
There is no data available to recommend the sequential use of Fasturtec and allopurinol.
Na voljo ni podatkov, ki bi podprli zaporedno uporabo Fasturteca in alopurinola.
To ensure accurate measurement of uric acid plasma level during treatment with Fasturtec, a strict sample handling procedure must be followed (see section 6.6).
Da bi zagotovili točne meritve ravni sečne kisline v plazmi med zdravljenjem s Fasturtecom, se morate strogo držati postopka ravnanja z vzorci (glejte poglavje 6. 6).
No metabolism studies have been performed.
Študij metabolizma niso izvedli.
3 4.6 Pregnancy and lactation
Študij na živalih za oceno vpliva na porod in poporodni razvoj niso opravili (glejte poglavje 5. 3).
The potential risk for humans is unknown.
Morebitno tveganje pri človeku ni znano.
Fasturtec should not be used during pregnancy or in breast- feeding women.
Fasturteca ne smete uporabljati pri nosečnicah ali ženskah, ki dojijo.
It is unknown whether rasburicase is excreted in human milk.
Ni znano ali se razburikaza izloča v materinem mleku.
The most significant drug-related adverse events were common allergic reactions, mainly rashes and urticaria.
Najbolj značilni neželeni učinki so bile pogoste alergijske reakcije, predvsem izpuščaji in urtikarija.
Cases of hypotension (< 1%), bronchospasm (< 1%), rhinitis (< 0.1%) and severe hypersensitivity reactions (< 1%), including anaphylaxis (< 0.1%) have also been attributed to Fasturtec.
Fasturtec je povzročil tudi primere hipotenzije (< 1%), bronhospazma (< 1%), rinitisa (< 0, 1%) in hude preobčutljivostne reakcije (< 1%), vključno z anafilakso (< 0, 1%).