natgillin/translations-raw huggingface dataset:
Fasturtec works by allowing uric acid to more easily be removed from the body by the kidneys.
Fasturtec djeluje tako da omogućuje lakše uklanjanje mokraćne kiseline iz tijela putem bubrega.
Uncommon side effects (may affect up to 1 in 100 people): - severe hypersensitivity reactions, such as anaphylaxis (rare) including anaphylactic shock
Manje česte nuspojave (mogu se javiti u manje od 1 na 100 osoba): - teške reakcije preosjetljivosti, kao što je anafilaksija (rijetko) uključujući i anafilaktički šok
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 7.5 mg
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 7,5 mg
Anti-rasburicase antibodies have been detected in treated patients and healthy volunteers administered rasburicase.
Protutijela na razburikazu utvrđena su u liječenih bolesnika i zdravih dobrovoljaca koji su primili razburikazu.
Rasburicase is a highly potent uricolytic agent that catalyses enzymatic oxidation of uric acid into allantoin, a water soluble product, easily excreted by the kidneys in the urine.
Razburikaza je visoko potentna urikolitička tvar koja katalizira enzimsku oksidaciju mokraćne kiseline u alantoin, produkt topiv u vodi, koji se može lako izlučiti mokraćom putem bubrega.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1.5 mg
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1,5 mg
- have a history of haemolytic anaemia (an illness caused by red blood cells being abnormally broken down).
(naveden u dijelu 6.). - ako u povijesti bolesti imate hemolitičku anemiju (bolest uzrokovana prekomjernom razgradnjom crvenih krvnih stanica).
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.
Primjena lijeka Fasturtec smanjuje koncentraciju mokraćne kiseline ispod razine normalnih vrijednosti te putem tog mehanizma smanjuje vjerojatnost razvoja zatajenja bubrega uzrokovanog taloženjem kristala mokraćne kiseline u bubrežnim tubulima, što je posljedica hiperuricemije.
Powder: alanine mannitol disodium phosphate dodecahydrate disodium phosphate dihydrate sodium dihydrogen phosphate dihydrate
Prašak: alanin manitol natrijev hidrogenfosfat dodekahidrat natrijev hidrogenfosfat dihidrat natrijev dihidrogenfosfat dihidrat
A cross-study comparison revealed that after administration of rasburicase at 0.15 or 0.20 mg/kg, the geometric mean values of body-weight normalized clearance were approximately 40% lower in Japanese (n=20) than that in Caucasians (n=26).
Usporedba podataka iz svih ispitivanja otkrila je da je nakon primjene razburikaze u dozi od 0,15 odnosno 0,20 mg/kg geometrijska sredina vrijednosti klirensa korigiranih s obzirom na tjelesnu težinu bila približno 40% niža u Japanaca (n=20) nego u bolesnika bijele rase (n=26).
- Haemolysis - Haemolytic anaemia
- hemoliza - hemolitička anemija - methemoglobinemija
The following information is intended for healthcare professionals only: See section 3 “How to use Fasturtec” and practical information on preparation and handling given below.
Sljedeće informacije namijenjene su samo zdravstvenim djelatnicima: Vidjeti dio 3.
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for concentrate for solution for infusion 3 vials and 3 ampoules
OBLIK I SADRŽAJ Prašak i otapalo za koncentrat za otopinu za infuziju 3 bočice i 3 ampule
Rasburicase being an enzyme itself, it would be an unlikely candidate for drug-drug interactions.
S obzirom da je razburikaza i sama enzim, nije vjerojatno da će uzrokovati interakcije s drugim lijekovima.
Clearance of rasburicase was ca. 3.5 ml/h/kg.
Klirens razburikaze iznosi oko 3,5 ml/h/kg.
• rash, itching or hives (nettle-type rash) on the skin
• osip, svrbež ili koprivnjača na koži
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
Fasturtec se primjenjuje jednom dnevno u obliku 30-minutne intravenske infuzije u 50 ml 0,9%-tne otopine natrijevog klorida (9 mg/ml) (vidjeti dio 6.6).
Driving and using machines No information on the ability to drive and use machines is available.
Nema podataka o sposobnosti upravljanja vozilom i rukovanja strojeva.
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.
Povećanu količinu vodikova peroksida koja prelazi uobičajene razine mogu eliminirati endogeni antioksidansi te je rizik od hemolize povećan samo u bolesnika s deficijencijom G6PD ili nasljednom anemijom.
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for concentrate for solution for infusion 1 vial and 1 ampoule
OBLIK I SADRŽAJ Prašak i otapalo za koncentrat za otopinu za infuziju 1 bočica i 1 ampula
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Lijek se izdaje na ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2)
Uric acid levels were <2 mg/dl in 96% of patients in the two arms containing rasburicase and 5% of patients in the allopurinol arm at 4 hours of the day 1 dose.
Četiri sata nakon primjene doze prvog dana liječenja razine mokraćne kiseline bile su < 2 mg/dl u 96% bolesnika u dvije skupine koje su primale razburikazu i u 5% bolesnika u skupini koja je primala alopurinol.
G6PD deficiency and other cellular metabolic disorders known to cause haemolytic anaemia.
Deficijencija glukoza-6-fosfat dehidrogenaze (G6PD) i ostali poremećaji staničnog metabolizma koji uzrokuju hemolitičku anemiju.
It is unknown whether rasburicase is excreted in human milk.
Nije poznato izlučuje li se razburikaza u majčino mlijeko u ljudi.
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.
Enzimska razgradnja mokraćne kiseline u alantoin uzrokovana razburikazom dovodi do nastajanja vodikova peroksida te je u određenim rizičnim populacijama, kao što su bolesnici s deficijencijom G6PD, opažena hemolitička anemija ili methemoglobinemija.
At present, there is insufficient data available on patients being retreated to recommend multiple treatment courses.
Zasad nema dovoljno podataka o bolesnicima kojima je ponovljena terapija razburikazom te se stoga ne može preporučiti ponavljanje terapije.
Very common side effects (may affect more than 1 in 10 people): - diarrhoea - vomiting - nausea
Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba): - proljev - povraćanje - mučnina - glavobolja - vrućica
In humans, uric acid is the final step in the catabolic pathway of purines.
Mokraćna kiselina je u ljudi konačan produkt katabolizma purina.
- Anaphylaxis - Anaphylactic shock*
- anafilaksija - anafilaktički šok*
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT/AMPOULE
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE OTAPALO/AMPULA
STATEMENT OF ACTIVE SUBSTANCE(S) rasburicase 7.5 mg/5 ml rasburicase produced by genetechnology in Saccharomyces cerevisiae strain
TVARI razburikaza 7,5 mg/5 ml razburikaza proizvedena genskom tehnologijom na soju Saccharomyces cerevisiae
Fasturtec contains the active ingredient rasburicase.
Fasturtec sadrži djelatnu tvar razburikazu.
MARKETING AUTHORISATION NUMBER(S) EU/1/00/170/001-002
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/00/170/001-002
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS POWDER/VIAL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE PRAŠAK/BOČICA
In pivotal clinical studies, 246 paediatric patients ( mean age 7 years, range 0 to17) 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).
U ključnim je kliničkim ispitivanjima 246 pedijatrijskih bolesnika (prosječna dob 7 godina, raspon od 0 do 17 godina) liječeno razburikazom u dozi od 0,15 mg/kg na dan ili 0,20 mg/kg na dan tijekom 1 do
- If you have any further questions, ask your doctor, nurse or hospital pharmacist.
- Ako imate dodatnih pitanja, obratite se svom liječniku, medicinskoj sestri ili bolničkom ljekarniku.
Powder also contains: alanine, mannitol, disodium phosphate dodecahydrate, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate.
Prašak također sadrži: alanin, manitol, natrijev hidrogenfosfat dodekahidrat, natrijev hidrogenfosfat dihidrat i natrijev dihidrogenfosfat dihidrat.
Solvent: poloxamer 188 water for injection
Otapalo: poloksamer 188 voda za injekciju
Solvent: poloxamer 188, water for injection
Otapalo: poloksamer 188, voda za injekciju
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.
Potreban volumen rekonstituirane otopine, iz jedne ili više bočica, mora se dodatno razrijediti 0,9%-tnom otopinom natrijevog klorida (9 mg/ml) kako bi se dobio ukupan volumen od 50 ml.
MARKETING AUTHORISATION NUMBER(S) EU/1/00/170/001
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/00/170/001
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 1 POWDER VIAL and 1 SOLVENT AMPOULE
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE OD 1 BOČICE S PRAŠKOM I 1 AMPULE S OTAPALOM
Fasturtec is provided as a powder for concentrate for solution for infusion (powder for sterile concentrate) with a solvent.
Fasturtec je dostupan na tržištu u obliku praška za koncentrat za otopinu za infuziju (prašak za sterilni koncentrat) s otapalom.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for rasburicase 7.5 mg
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Otapalo za razburikazu 7,5 mg
Fasturtec must be reconstituted with the entire volume of the supplied solvent (e.g. 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).
Fasturtec se mora rekonstituirati s cjelokupnim volumenom priloženog otapala (npr. bočica s 1,5 mg razburikaze rekonstituira se s 1 ml otapala u ampuli; bočica sa 7,5 mg razburikaze rekonstituira se s 5 ml otapala u ampuli).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 3 POWDER VIALS AND 3 SOLVENT AMPOULES
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP PAKIRANJE OD 3 BOČICE S PRAŠKOM I 3 AMPULE S OTAPALOM
STATEMENT OF ACTIVE SUBSTANCE(S) rasburicase 1.5 mg/1 ml rasburicase produced by genetechnology in Saccharomyces cerevisiae strain
TVARI razburikaza 1,5 mg/1 ml razburikaza proizvedena genskom tehnologijom na soju Saccharomyces cerevisiae
The uric acid response rate (proportion of patients with plasma uric acid levels ≤7.5 mg/dl from day 3 to day 7 after initiation of antihyperuricemic treatment) was 87% in arm A, 78% in arm B, and 66% in arm C. The response rate in arm A was significantly greater than in arm C (p=0.0009); the response rate was higher for arm B compared to arm C although this difference was not statistically significant.
Stopa odgovora mokraćne kiseline (udio bolesnika čije su vrijednosti mokraćne kiseline bile ≤ 7,5 mg/dl od 3. do 7. dana nakon početka antihiperuricemične terapije) iznosila je 87% u skupini A, 78% u skupini B te 66% u skupini C.
METHODS AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use
NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitati Uputu o lijeku.
MARKETING AUTHORISATION NUMBER(S) EU/1/00/170/002
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/00/170/002
If you have any further questions on the use of this medicine, ask your doctor, nurse or hospital pharmacist.
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku, medicinskoj sestri ili bolničkom ljekarniku.
Pharmacotherapeutic group: Detoxifying agents for antineoplastic treatment, ATC code: V03AF07.
ATK oznaka: V03AF07.
In clinical trials, haematological disorders such as haemolysis, haemolytic anaemia and methaemoglobinaemia are uncommonly caused by Fasturtec.
U kliničkim je ispitivanjima Fasturtec manje često uzrokovao hematološke poremećaje poput hemolize, hemolitičke anemije i methemoglobinemije.
Renal elimination of rasburicase is considered to be a minor pathway for rasburicase clearance.
Eliminacija razburikaze putem bubrega smatra se sporednim putem u klirensu razburikaze.
- The other ingredients of the solvent are: poloxamer 188, water for injection.
- Pomoćne tvari u otapalu su: poloksamer 188 i voda za injekciju.
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).
Razburikaza se mora rekonstituirati s cjelokupnim volumenom priložene ampule s otapalom (bočica s 1,5 mg razburikaze rekonstituira se s 1 ml otapala u ampuli; bočica sa 7,5 mg razburikaze rekonstituira se s 5 ml otapala u ampuli).
• coughing or wheezing
• kašljanje ili piskanje pri disanju
Do not use any glucose solution for dilution due to potential incompatibility.
Zbog mogućih inkompatibilnosti, za razrjeđivanje se ne smiju koristiti otopine glukoze.
Package leaflet: Information for the user Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion rasburicase
Uputa o lijeku: Informacija za korisnika Fasturtec 1,5 mg/ml prašak i otapalo za koncentrat za otopinu za infuziju razburikaza
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 3 POWDER VIALS and 3 SOLVENT AMPOULES
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE OD 3 BOČICE S PRAŠKOM I 3 AMPULE S OTAPALOM
Reconstitution results in a solution with a concentration of 1.5 mg/ml to be further diluted with sodium chloride 9 mg/ml (0.9%).
Rekonstitucijom se dobije otopina koncentracije od 1,5 mg/ml, koja se naknadno mora razrijediti 0,9%-tnom otopinom natrijevog klorida (9 mg/ml).
Methaemoglobinaemia has been reported in patients receiving Fasturtec.
U bolesnika koji su primali Fasturtec prijavljena je methemoglobinemija.
Therapeutic indications
4.1 Terapijske indikacije
Reconstitution required with the entire contents of the 1 ml solvent ampoule Intravenous use
Rekonstituciju je potrebno provesti s cjelokupnim sadržajem ampule s otapalom od 1 ml.
If use of a separate line is not possible, the line should be flushed out with saline solution between infusion of chemotherapeutic agents and rasburicase.
Ako upotreba zasebne infuzijske linije nije moguća, između infuzije kemoterapeutika i razburikaze liniju treba isprati fiziološkom otopinom.
Haemolysis has been reported in patients receiving Fasturtec.
U bolesnika koji su primali Fasturtec zabilježena je hemoliza.
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.
Rekonstitucijom se dobije otopina koncentracije od 1,5 mg/ml razburikaze, koja se dodatno mora razrijediti intravenskom 0,9%-tnom otopinom natrijevog klorida (9 mg/ml).
After reconstitution or dilution an immediate use is recommended.
Preporučuje se lijek upotrijebiti odmah nakon rekonstitucije ili razrjeđivanja.
If use of a separate line is not possible, the line should be flushed out with saline solution between chemotherapeutic agent infusions and rasburicase.
Ako primjena putem zasebne infuzijske linije nije moguća, između infuzije kemoterapeutika i razburikaze liniju treba isprati fiziološkom otopinom.
Pack of 3 vials of 1.5 mg rasburicase and 3 ampoules of 1 ml solvent.
Pakiranje od 3 bočice s 1,5 mg razburikaze i 3 ampule s 1 ml otapala.
3 vials of 1.5 mg rasburicase and 3 ampoules of 1 ml solvent.
3 bočice s 1,5 mg razburikaze i 3 ampule s 1 ml otapala.
Hydrogen peroxide is a by-product of the conversion of uric acid to allantoin.
Nusproizvod pretvorbe mokraćne kiseline u alantoin je vodikov peroksid.
Reconstitution required with the entire contents of the 5 ml solvent ampoule Intravenous use
Rekonstituciju je potrebno provesti s cjelokupnim sadržajem ampule s otapalom od 5 ml.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for rasburicase 1.5 mg
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Otapalo za razburikazu 1,5 mg
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Fasturtec 1.5 mg/ml powder for sterile concentrate rasburicase
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Fasturtec 1,5 mg/ml prašak za sterilni koncentrat razburikaza i.v.
NAME OF THE MEDICINAL PRODUCT Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion.
NAZIV LIJEKA Fasturtec 1,5 mg/ml prašak i otapalo za koncentrat za otopinu za infuziju
Tabulated list of adverse reactions MedDRA Organ system classes
MedDRA klasifikacija organskih sustava
Rasburicase solution should be infused over 30 minutes.
Infuzija otopine razburikaze treba trajati 30 minuta.
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.
Prašak se nalazi u prozirnoj staklenoj (tip I) bočici od 10 ml s gumenim čepom, a otapalo u prozirnoj staklenoj (tip I) ampuli od 5 ml.
The powder is supplied in 10 ml clear glass vial with a rubber stopper and the solvent in a 5 ml clear glass ampoule.
Prašak se nalazi u prozirnoj staklenoj bočici od 10 ml s gumenim čepom, a otapalo u prozirnoj staklenoj ampuli od 5 ml.
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.
Prašak se nalazi u prozirnoj staklenoj (tip I) bočici od 3 ml s gumenim čepom, a otapalo u prozirnoj staklenoj (tip I) ampuli od 2 ml.
- The other ingredients of the powder are: alanine, mannitol, disodium phosphate dodecahydrate,
- Pomoćne tvari u prašku su: alanin, manitol, natrijev hidrogenfosfat dodekahidrat, natrijev hidrogenfosfat dihidrat i natrijev dihdrogenfosfat dihidrat.
Pack of 1 vial of 7.5 mg rasburicase and 1 ampoule of 5 ml solvent.
Pakiranje od 1 bočice sa 7,5 mg razburikaze i 1 ampule s 5 ml otapala.
The powder is supplied in 3 ml clear glass vial with a rubber stopper and the solvent in a 2 ml clear glass ampoule.
Prašak se nalazi u prozirnoj staklenoj bočici od 3 ml s gumenim čepom, a otapalo u prozirnoj staklenoj ampuli od 2 ml.
If you notice any of these, tell your doctor, nurse or hospital pharmacist.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, medicinsku sestru ili bolničkog ljekarnika.
1 vial of 7.5 mg rasburicase and 1 ampoule of 5 ml solvent.
1 bočice sa 7,5 mg razburikaze i 1 ampule s 5 ml otapala.
NAME OF THE MEDICINAL PRODUCT Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion rasburicase
Fasturtec 1,5 mg/ml prašak i otapalo za koncentrat za otopinu za infuziju razburikaza
- The active substance is rasburicase 1.5 mg/ml.
Sadržaj pakiranja i druge informacije Što Fasturtec sadrži - Djelatna tvar je razburikaza 1,5 mg/ml.
SANOFI BULGARIA EOOD Тел.
Sanofi Malta Ltd.
- Headache +
- glavobolja
Reconstitution of the solution:
Rekonstitucija otopine:
You may need to read it again.
Možda ćete ju trebati ponovno pročitati.
Up to 12 days from the date of manufacture.
Do 12 dana od datuma proizvodnje.
Intravenous administration should not be protracted over more than 2 hours.
Intravensku primjenu ne bi trebalo produžiti na razdoblje dulje od 2 sata.
Yttriga is contraindicated in Pregnancy.
Yttriga je kontraindicirana u trudnoći.
Time-points for measurements were 5 min, 1, 6, 24, 96 and 360 hours.
Vremenske točke mjerenja bile su 5 min, 1, 6, 24, 96 i 360 sati.
Faecal and urinary elimination is slow: about 31 % of the administered activity is eliminated in 15 days.
Eliminacija fecesom i urinom je spora: oko 31% primijenjene aktivnosti eliminira se unutar 15 dana.
Date of renewal: 06/01/2011
Datum obnove: 06.01.2011.
The risk to receive a possible overdose is small.
Rizik primanja moguće prevelike doze vrlo je mali.
Please tell your doctor or pharmacist, if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Molimo Vas da svom liječniku ili ljekarniku kažete ako uzimate ili ste nedavno uzimali bilo kakav drugi lijek, uključujući i lijekove nabavljene bez recepta.
Further information on the preparation of the product is given in section 12.
Daljnje informacije o pripremi proizvoda navedene su u dijelu 12.
Like all medicines, Yttriga can cause side effects, although not everybody gets them.
Kao i svi lijekovi, Yttriga može uzrokovati nuspojave, iako se one ne pojavljuju kod svih.
Particular care should be taken when administering radioactive medicinal products to children and adolescents (from 2 to 16 years old).
Posebno treba paziti prilikom davanja radioaktivnih lijekova djeci i adolescentima (od 2 do 16 godina starosti).
Your doctor will consider alternative techniques which do not involve ionising radiation.
Liječnik će razmotriti druge tehnike koje ne uključuju ionizirajuće zračenje.
The vial should never be opened and must be kept inside its lead shielding.
Bočica se nikada ne smije otvarati i mora se čuvati unutar svog olovnog kućišta.
Activity may be measured using an ionisation chamber.
Aktivnost se može izmjeriti korištenjem ionizacijske komore.
For this product the effective dose to a 70 kg adult resulting from an intravenously injected activity of 1 GBq is 665 mSv.
Za ovaj proizvod efektivna doza za odraslu osobu od 70 kg kao rezultat intravenski injicirane aktivnosti od 1 GBq iznosi 665 mSv.
If you have missed a period, you should assume to be pregnant until a pregnancy test conducted is negative.
Ako Vam je mjesečnica izostala, trebate pretpostaviti da ste trudni sve dok test trudnoće nije negativan.
D-38110 Braunschweig Germany
D-38110 Braunschweig
In any case the blood parameters of the patient have to be monitored and the appropriate actions immediately taken if there is evidence of damage to the blood marrow.
U svakom slučaju treba nadzirati parametre krvne slike pacijenta i odmah poduzeti prikladne mjere u slučaju da postoji dokaz oštećenja koštane srži.
However, should this occur, you will receive appropriate treatment from your doctor.
Ipak, u slučaju da se to dogodi, liječnik će primijeniti odgovarajuće liječenje.
What Yttriga looks like and contents of the pack
Kako Yttriga izgleda i sadržaj pakovanja
Read all of this leaflet carefully before you start using this medicine.
Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati ovaj lijek.
These complexes are rapidly eliminated by the kidneys.
Ovi se kompleksi brzo eliminiraju putem bubrega.
Yttrium (90Y) has a half-life of 2.67 days (64.1 hours).
Itrij (90Y) ima vrijeme poluraspada od 2,67 dana (64,1 sat).
Liver uptake decreases then to 8.4 % 24 hours after injection.
Apsorpcija u jetri zatim se smanjuje na 8,4% 24 sata nakon injekcije.
The chelating efficacy is greatest immediately or within one hour of exposure when the radionuclide is circulating in or available to tissue fluids and plasma.
Djelotvornost kelacije najveća je neposredno ili unutar jednoga sata od izlaganja kada je radionuklid u cirkulaciji ili je dostupan u tekućinama u tkivima i plazmi.
In bone, percentage of injected activity increases from 3.1 % at 5 min to 18 % at 6 hours and then decreases with time.
U kostima, postotak primijenjene aktivnosti povećava se s 3,1% nakon 5 min na 18% nakon 6 sati, a zatim s vremenom opada.
The administration of radioactive medicinal products creates risks for other persons from external radiation or contamination from spills of urine, vomiting, etc.
Primjena radioaktivnih lijekova stvara rizik za druge osobe od vanjskog zračenja ili kontaminacije prolivenim urinom, povraćanjem, itd.