natgillin/translations-raw huggingface dataset:
Common (may affect up to 1 in 10 patients)
Često (mogu se javiti u manje od 1 na 10 bolesnika)
Cellulose, microcrystalline (E460) Calcium hydrogen phosphate, anhydrous Maize starch
6.1 Popis pomoćnih tvari celuloza, mikrokristalična (E460) kalcijev hidrogenfosfat, bezvodni kukuruzni škrob povidon glicerin magnezijev stearat meglumin poloksamer 188
Repaglinide Accord should be taken with caution.
Potreban je oprez pri uzimanju lijeka Repaglinid Accord.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
OSTALI UVJETI I ZAHTJEVI ZA STAVLJANJE GOTOVOG LIJEKA U PROMET
Pharmaco-therapeutic group: Drugs used in diabetes, other blood glucose lowering drugs, excl. insulins, ATC code: A10B X02
Farmakoterapijska skupina: lijekovi za liječenje šećerne bolesti, drugi lijekovi za snižavanje razine glukoze u krvi, osim inzulina.
Glycerin
BLISTER
LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS
OBLIK I SADRŽAJ Tableta
METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use.
OBLIK I SADRŽAJ Tableta 100 tableta NAČIN I PUT PRIMJENE LIJEKA Prije uporabe pročitajte Uputu o lijeku.
NAME OF THE MEDICINAL PRODUCT Repaglinide Accord 0.5 mg tablets Repaglinide STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 0.5 mg of repaglinide.
NAZIV GOTOVOG LIJEKA Repaglinid Accord 0,5 mg tablete repaglinid KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH TVARI Svaka tableta sadrži 0,5 mg repaglinida.
Periodic Safety Update Reports
• Periodička izvješća o neškodljivosti lijeka
Repaglinide Accord is used to control type 2 diabetes in adults as an add-on to diet and exercise: treatment is usually started if diet, exercise and weight reduction alone have not been able to control (or lower) your blood sugar.
S liječenjem se obično započinje kada se samo dijetom, tjelovježbom i smanjenjem tjelesne težine ne može postići zadovoljavajuća regulacija (ili snižavanje) razine šećera u krvi.
What Repaglinide Accord looks like and contents of the pack The Repaglinide Accord 0.5 mg tablet is white to off white, round, biconvex, with beveled edge, with inscription ‘R' on one side and plain on other side.
Repaglinid Accord 0,5 mg tablete su bijele do bjelkaste boje, okrugle, bikonveksne, s ukošenim rubovima, s utisnutom oznakom „R“ na jednoj strani, te bez oznaka na drugoj strani.
Repaglinide Accord 0.5 mg: Each tablet contains 0.5 mg repaglinide Repaglinide Accord 1 mg: Each tablet contains 1 mg repaglinide Repaglinide Accord 2 mg: Each tablet contains 2 mg repaglinide The other ingredients are microcrystalline cellulose, anhydrous calcium hydrogen phosphate, maize starch, meglumine, poloxamer 188, povidone, glycerin, magnesium stearate, yellow iron oxide (E172) only in the 1 mg tablets and red iron oxide (E172) only in the 2 mg tablets.
Drugi sastojci su mikrokristalična celuloza, bezvodni kalcijev hidrogenfosfat, kukuruzni škrob, meglumin, poloksamer 188, povidon, glicerin, magnezijev stearat, žuti željezov oksid (E172) samo u tabletama od 1 mg i crveni željezov oksid (E172) samo u tabletama od 2 mg.
Trials investigating the combination with other insulin secretagogues have not been performed.
Nisu provedena ispitivanja o kombinaciji repaglinida s drugim lijekovima koji potiču lučenje inzulina.
Light yellow to yellow colored, round, biconvex with beveled edge, uncoated tablets, with inscription “R” on one side and plain on other side, may have mottled appearance.
Svijetložute do žute, okrugle, bikonveksne neobložene tablete s ukošenim rubovima, s utisnutom oznakom „R“ na jednoj strani, bez oznaka na drugoj strani te mogu imati točkasti izgled.
NAME OF THE MEDICINAL PRODUCT Repaglinide Accord 0.5 mg tablets
Repaglinid Accord 0,5 mg tablete
PARTICULARS TO APPEAR ONTHE OUTER PACKAGING HDPE BOTTLE
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU KUTIJA ZA BLISTERE
NAME OF THE MEDICINAL PRODUCT Repaglinide Accord 2 mg tablets
Repaglinid Accord 2 mg tablete
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTERS NAME OF THE MEDICINAL PRODUCT Repaglinide Accord 0.5 mg tablets Repaglinide STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 0.5 mg of repaglinide.
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU HDPE BOČICA NAZIV GOTOVOG LIJEKA Repaglinid Accord 0,5 mg tablete repaglinid KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH TVARI Svaka tableta sadrži 0,5 mg repaglinida.
MARKETING AUTHORISATION NUMBER EU/1/11/743/015
12. BROJEVI ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/11/743/015
The Repaglinide Accord 2 mg tablet is peach coloured, round, biconvex with beveled edge, with inscription 'R' on one side and plain on other side, may have mottled appearance
Repaglinid Accord 2 mg tablete su boje breskve, okrugle, bikonveksne, s ukošenim rubovima, sa utisnutom oznakom „R“ na jednoj strani, bez oznaka na drugoj strani, te mogu imati točkasti izgled.
The Repaglinide Accord 1 mg tablet is light yellow to yellow round, biconvex, with beveled edge, with inscription 'R' on one side and plain on other side, may have mottled appearance.
Repaglinid Accord 1 mg tablete su svijetložute do žute boje, okrugle, bikonveksne, s ukošenim rubovima, s utisnutom oznakom „R“ na jednoj strani, bez oznaka na drugoj strani, te mogu imati točkasti izgled.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTERS NAME OF THE MEDICINAL PRODUCT Repaglinide Accord 2 mg tablets Repaglinide STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 2 mg of repaglinide.
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU HDPE BOČICA NAZIV GOTOVOG LIJEKA Repaglinid Accord 2 mg tablete repaglinid KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH TVARI Svaka tableta sadrži 2 mg repaglinida.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTERS NAME OF THE MEDICINAL PRODUCT Repaglinide Accord 1 mg tablets Repaglinide STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 1 mg of repaglinide.
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU HDPE BOČICA NAZIV GOTOVOG LIJEKA Repaglinid Accord 1 mg tablete repaglinid KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH TVARI Svaka tableta sadrži 1 mg repaglinida.
How to store Repaglinide Accord Keep this medicine out of the sight and reach of children.
Ovaj lijek čuvajte izvan pogleda i dohvata djece.
MARKETING AUTHORISATION NUMBER(S) EU/1/11/743/005
12. BROJEVI ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/11/743/005
• St. John's wort (herbal medicine).
• gospina trava (biljni lijek).
NAME OF THE MEDICINAL PRODUCT Repaglinide Accord 2 mg tablets Repaglinide STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 2 mg of repaglinide.
HDPE BOČICA NAZIV GOTOVOG LIJEKA Repaglinid Accord 2 mg tablete repaglinid KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH TVARI Svaka tableta sadrži 2 mg repaglinida.
NAME OF THE MEDICINAL PRODUCT Repaglinide Accord 1 mg tablets
Repaglinid Accord 1 mg tablete
NAME OF THE MEDICINAL PRODUCT Repaglinide Accord 1 mg tablets Repaglinide STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 1 mg of repaglinide.
HDPE BOČICA NAZIV GOTOVOG LIJEKA Repaglinid Accord 1 mg tablete repaglinid KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH TVARI Svaka tableta sadrži 1 mg repaglinida.
Abdominal pain, diarrhoea Common Vomiting, constipation
Bol u trbuhu, proljev
• Acute coronary syndrome (but it may not be due to the medicine).
Rijetko (mogu se javiti u manje od 1 na 1000 bolesnika) • akutni koronarni sindrom (možda nije uzrokovan lijekom).
MARKETING AUTHORISATION NUMBER(S) EU/1/11/743/010
12. BROJEVI ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/11/743/010
GENERAL CLASSIFICATION FOR SUPPLY INSTRUCTIONS ON USE INFORMATION IN BRAILLE Repaglinide Accord 2 mg UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD
Peach colored, round, biconvex with beveled edge, uncoated tablets, with inscription “R” on one side and plain on other side, may have mottled appearance.
Boje breskve, okrugle, bikonveksne, s ukošenim rubovima, bez filmske obloge, s utisnutom oznakom „R“ na jednoj strani, bez oznaka na drugoj strani te mogućeg točkastog izgleda.
SPECIAL STORAGE CONDITIONS SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
DRUGA POSEBNA UPOZORENJA, AKO JE POTREBNO ROK VALJANOSTI Rok valjanosti POSEBNE MJERE ČUVANJA 10. POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ILI OTPADNIH MATERIJALA KOJI POTJEČU
Repaglinide Accord is not recommended.
Nemojte uzimati Repaglinid Accord:
For each of the two syringes:
NAVOĐENJE DJELATNE(IH) TVARI
There were no new safety concerns arising from this small study, but 5-year data are yet not available.
Iz ovog malog ispitivanja nisu proizašla nova sigurnosna pitanja, ali još nisu dostupni 5-godišnji podaci.
Adult females (including Elderly)
Odrasle žene (uključujući starije)
Harmful for those suffering from alcoholism.
Štetno za osobe koje boluju od alkoholizma.
The event was not observed in major clinical studies (CONFIRM, FINDER 1, FINDER 2, NEWEST).
Događaj nije primijećen u glavnim kliničkim ispitivanjima (CONFIRM, FINDER 1, FINDER 2, NEWEST).
Approximately 20% of patients were pre/perimenopausal.
Približno 20% bolesnica bilo je u predmenopauzi/perimenopauzi.
Fulvestrant is eliminated mainly in metabolised form.
Fulvestrant se uglavnom eliminira u metaboliziranom obliku.
Type of estimate; treatment comparison
Vrsta procjene; usporedba liječenja
Fulvestrant showed no genotoxic potential.
Fulvestrant nije pokazao genotoksični potencijal.
However, if you feel tired after treatment do not drive or use machines.
Međutim, ako se osjećate umorno nakon primjene lijeka, nemojte voziti niti raditi sa strojevima.
*Response results based on confirmed and unconfirmed responses.
*Rezultati za odgovore temelje se na potvrđenim i nepotvrđenim odgovorima.
All other side effects:
Sve ostale nuspojave:
*(31% maturity)-not final OS analysis **for patients with measurable disease
*(zrelost podataka: 31%) - nije završna analiza OS-a **za bolesnice s mjerljivom bolešću
You must not use Faslodex if you are pregnant.
Ne smijete koristiti Faslodex ako ste trudni.
• Sudden weakness, numbness, tingling, or loss of movement in your leg, especially on only one side of your body, sudden problems with walking or balance (peripheral neuropathy)
• iznenadna slabost, utrnulost, trnci ili gubitak pokreta u nozi, posebice samo na jednoj strani tijela, iznenadni problemi kod hodanja ili ravnoteže (periferna neuropatija)
Warning - Do not autoclave safety needle (BD SafetyGlide Shielding Hypodermic Needle) before use.
Upozorenje - nemojte autoklavirati sigurnosnu iglu (BD SafetyGlide Shielding Hypodermic Needle) prije primjene.
Estrogens, a type of female sex hormones, can in some cases be involved in the growth of breast cancer.
Estrogeni, jedna vrsta ženskih spolnih hormona, mogu u nekim slučajevima biti uključeni u rast raka dojke.
This medicine may pose a risk to the aquatic environment.
Ovaj lijek može predstavljati rizik za vodeni okoliš.
Number of patients at risk FUL500 230
Broj bolesnica pod rizikom FUL500 230
Clinical efficacy and safety in advanced breast cancer
Klinička djelotvornost i sigurnost kod uznapredovalog raka dojke
Supportive PFS analyses were based on an Independent Central Radiology Review.
Potporne analize PFS-a temeljile su se na neovisnoj središnjoj radiološkoj ocjeni.
In particular, you should tell your doctor if you are using anticoagulants (medicines to prevent blood clots).
Naročito je važno da obavijestite liječnika ako uzimate antikoagulanse (lijekove za sprječavanje zgrušavanja krvi).
For detailed instructions for administration, see section 6.6.
Za detaljne upute za primjenu vidjeti dio 6.6.
Patients with a best objective response of complete response, partial response or stable disease ≥24 weeks.
Bolesnice s najboljim objektivnim odgovorom na terapiju u kompletnom odgovoru, djelomičnom odgovoru i stabilnoj bolesti tijekom ≥24 tjedna.
Date of first authorisation: 10 March 2004 Date of latest renewal: 10 March 2009
Datum posljednje obnove odobrenja: 10. ožujka 2009.
Due to the mechanism of action of fulvestrant, there is a potential risk of osteoporosis.
S obzirom na mehanizam djelovanja fulvestranta, postoji mogući rizik od osteoporoze.
No interaction studies were conducted on competitive protein binding.
Nisu provedena ispitivanja interakcija u vezi s kompetitivnim vezanjem na proteine.
Store and transport in a refrigerator.
Čuvati i prevoziti na hladnom.
% of patients with CB; absolute difference in
% bolesnika s CB; apsolutna razlika u %
, hepatitis f, elevated gamma-GT
, hepatitis f, povišene razine gama-GT
You may need immediate medical treatment if you experience any of the following side effects:
Možda ćete trebati hitno liječenje ako se javi neka od sljedećih nuspojava:
• Remove glass syringe barrel from tray and check that it is not damaged.
• Izvadite stakleni trup štrcaljke iz podloška i provjerite da nije oštećen.
Pharmacotherapeutic group: Endocrine therapy, Antiestrogens, ATC code: L02BA03
Farmakoterapijska skupina: endokrina terapija, antiestrogeni, ATK oznaka: L02BA03
Fulvestrant is highly (99%) bound to plasma proteins.
Fulvestrant se u velikoj mjeri (99%) veže na proteine u plazmi.
Time (Month)
Vrijeme (mjeseci)
If overdose occurs, symptomatic supportive treatment is recommended.
U slučaju predoziranja preporučuje se simptomatsko potporno liječenje.
OS is presented for the final survival analyses at 75% maturity.
Prikazano je OS za konačne analize preživljenja pri 75%-tnoj zrelosti podataka.
These occurred at exposure levels higher than in patients (Cmax >15 times) and are likely to be of limited significance for human safety at the clinical dose.
Ti su se učinci javili pri razinama izloženosti višima nego u bolesnica (Cmax >15 puta) i vjerojatno imaju ograničen značaj za sigurnost u ljudi kod primjene kliničkih doza.
The safety and efficacy of Faslodex in children from birth to 18 years of age have not been established.
Sigurnost i djelotvornost lijeka Faslodex u djece u dobi od rođenja do 18 godina nisu još ustanovljene.
Identified metabolites (includes 17-ketone, sulphone, 3-sulphate, 3- and 17-glucuronide metabolites) are either less active or exhibit similar activity to fulvestrant in antiestrogen models.
Poznati metaboliti (obuhvaćaju 17-keton, sulfon, 3-sulfat, 3- i 17-glukuronid metabolite) su ili manje aktivni ili pokazuju aktivnost sličnu fulvestrantu u antiestrogenskim modelima.
The acute toxicity of fulvestrant is low.
Akutna toksičnost fulvestranta je mala.
• Thromboembolism (increased risk of blood clots)*
• tromboembolija (povećan rizik od krvnih ugrušaka)*
palbociclib+fulvestrant placebo+fulvestrant
palbociklib+fulvestrant placebo+fulvestrant
• Bruising and bleeding at the site of injection
• modrice i krvarenje na mjestu injekcije
Effects on the postmenopausal endometrium
Učinci na endometrij u postmenopauzi
Seventy seven percent (77%) of the study population had estrogen receptor positive breast cancer.
Sedamdeset i sedam posto (77%) ispitivane populacije imalo je rak dojke pozitivan na estrogenske receptore.
There were no statistically significant differences in any of these endpoints between the two treatment groups.
Nije bilo statistički značajne razlike između dviju terapijskih skupina glede bilo kojih od mjera ishoda.
The frequency has been calculated using the upper limit of the 95% confidence interval for the point estimate.
Učestalost je izračunata primjenom gornje granice 95%-tnog intervala pouzdanosti za točkovnu procjenu.
Your healthcare professional will be responsible for the correct storage, use and disposal of Faslodex.
Zdravstveni radnik bit će odgovoran za pravilno čuvanje, uporabu i zbrinjavanje lijeka Faslodex.
Children and adolescents Faslodex is not indicated in children and adolescents under 18 years.
Djeca i adolescenti Faslodex nije namijenjen za primjenu u djece i adolescenata mlađih od 18 godina.
Faslodex is not recommended for use in children and adolescents as safety and efficacy have not been established in this group of patients (see section 5.1).
Faslodex se ne preporučuje za primjenu u djece i adolescenata jer nisu ustanovljene sigurnost primjene i djelotvornost u toj dobnoj skupini (vidjeti dio 5.1).
Clear, colourless to yellow, viscous solution.
Bistra, bezbojna do žuta, viskozna otopina.
The metabolism of fulvestrant has not been fully evaluated, but involves combinations of a number of possible biotransformation pathways analogous to those of endogenous steroids.
Metabolizam fulvestranta nije u potpunosti razjašnjen, ali uključuje kombinacije većeg broja mogućih putova biotransformacije, analognih onima endogenih steroida.
ADR was not observed in FALCON.
Nuspojava nije opažena u ispitivanju FALCON.
Frequency groupings are defined according to the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100).
Za učestalost pojavljivanja korištena je sljedeća kategorizacija: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100).
This is calculated as 3/560 (where 560 is the number of patients in the major clinical studies), which equates to a frequency category of ‘uncommon'.
Tako izračunata vrijednost iznosi 3/560 (gdje je 560 broj bolesnika u glavnim kliničkim ispitivanjima), što odgovara kategoriji učestalosti „manje često“.
After temperature excursions, the product should be returned immediately to the recommended storage conditions (store and transport in a refrigerator 2°C - 8°C).
Nakon temperaturnog odstupanja, lijek treba odmah vratiti u preporučene uvjete čuvanja (čuvati i prevoziti na hladnom, na temperaturi od 2°C - 8°C).
If you have any questions about palbociclib, please ask your doctor.
Ako imate bilo kakvih pitanja o palbociklibu, obratite se svom liječniku.
The median time to death was 27.4 months for patients treated with Faslodex and 27.6 months for patients treated with anastrozole.
Medijan vremena do smrti iznosio je 27,4 mjeseca za bolesnice liječene lijekom Faslodex, a 27,6 mjeseci za bolesnice liječene anastrozolom.
K-M median in months; hazard ratio
K-M medijan u mjesecima; omjer hazarda
More than half (62%) had an ECOG PS of 0, 60% had visceral metastases, and 60% had received more than 1 prior hormonal regimen for their primary diagnosis.
Više od polovice bolesnica (62%) imalo je funkcionalni ECOG status 0, 60% njih imalo je visceralne metastaze, dok je njih 60% prethodno primilo više od 1 režima hormonske terapije za primarnu dijagnozu.
TTR*, Median [months (range)]
TTR*, medijan [mjeseci (raspon)]
Nominal p-value with no adjustments made for multiplicity between the initial overall survival analyses at 50% maturity and the updated survival analyses at 75% maturity.
Nominalna p-vrijednost bez korekcije za multiplicitet između inicijalnih analiza ukupnog preživljenja pri 50%-tnoj zrelosti podataka i ažuriranih analiza preživljenja pri 75%-tnoj zrelosti podataka.
Fulvestrant is subject to extensive and rapid distribution.
Fulvestrant se opsežno i brzo raspodjeljuje.
In toxicity studies with multiple intramuscular doses of fulvestrant in rats and dogs, the antiestrogenic activity of fulvestrant was responsible for most of the effects seen, particularly in the female reproductive system, but also in other organs sensitive to hormones in both sexes.
U istraživanjima toksičnosti višekratnih intramuskularnih doza fulvestranta u štakora i pasa, antiestrogeno djelovanje fulvestranta bilo je odgovorno za većinu opaženih učinaka, osobito u reproduktivnom sustavu ženki, ali i u drugim organima osjetljivima na hormone u oba spola.
The pre-filled syringe presentation consists of:
Pakiranje s napunjenom štrcaljkom sastoji se od:
The efficacy results of the FALCON study are presented in Table 4 and Figure 1.
Rezultati za djelotvornost u ispitivanju FALCON prikazani su u Tablici 4 i na Slici 1.
A more mature update of efficacy data is reported in Table 5.
Zreliji podaci o djelotvornosti navedeni su u Tablici 5.
The major route of excretion is via the faeces, with less than 1% being excreted in the urine.
Glavni put izlučivanja je fecesom, a manje od 1% izluči se mokraćom.
Tell your doctor, pharmacist, or nurse if you notice any of the following side effects:
Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako primijetite neku od sljedećih nuspojava:
Administer the injection according to the local guidelines for performing large volume intramuscular injections.
Primijenite injekciju prema lokalnim smjernicama za primjenu intramuskularnih injekcija velikog volumena.
To maintain sterility do not touch the syringe tip (B) (see Figure 2).
Kako bi se održala sterilnost, ne dirajte vrh štrcaljke (B) (vidjeti Sliku 2).
The large apparent volume of distribution at steady state (Vdss) of approximately 3 to 5 l/kg suggests that distribution is largely extravascular.
Velik prividni volumen distribucije u stanju dinamičke ravnoteže (Vdss) od oko 3 do 5 l/kg ukazuje da se uglavnom raspodjeljuje ekstravaskularno.
Other medicines and Faslodex
Drugi lijekovi i Faslodex
• Abnormal levels of liver enzymes (in blood tests)*
• abnormalna razina jetrenih enzima (u krvnim pretragama)*
PFS:Progression-free survival; ORR:Objective response rate; OR:Objective response; CBR:Clinical benefit rate; CB:Clinical benefit; OS:Overall survival; K-M:Kaplan-Meier; CI:Confidence interval; AI:Aromatase inhibitor; AE:Antiestrogen.
PFS: preživljenje bez progresije bolesti; ORR: objektivna stopa odgovora; OR: objektivni odgovor; CBR: stopa kliničke koristi; CB: klinička dobit; OS: ukupno preživljenje; K-M: Kaplan-Meier; CI: interval pouzdanosti; AI: inhibitor aromataze; AE: antiestrogen.
Grade ≥ 3 n (%)
≥ 3. stupanj n (%)
Patients continued to receive assigned treatment until objective disease progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
Bolesnice su nastavile primati dodijeljeno im liječenje do objektivne progresije bolesti, pogoršanja simptoma, neprihvatljive toksičnosti, smrti ili povlačenja pristanka, ovisno o tome što je nastupilo prvo.
Faslodex is contraindicated in pregnancy (see section 4.3).
Faslodex je kontraindiciran tijekom trudnoće (vidjeti dio 4.3).
Keep the pre-filled syringe in the original package, in order to protect from light.
Napunjenu štrcaljku čuvati u originalnom pakiranju radi zaštite od svjetlosti.
• Inflammation of the liver (hepatitis)
• upala jetre (hepatitis)
After intramuscular administration, the exposure is approximately dose-proportional in the dose range 50 to 500 mg.
Nakon intramuskularne primjene izloženost je približno proporcionalna dozi u rasponu doza od 50 do 500 mg.
What Faslodex is and what it is used for
Što je Faslodex i za što se koristi
Overall, Faslodex at the 250 mg monthly dose was at least as effective as anastrozole in terms of progression-free survival, objective response, and time to death.
Sveukupno je Faslodex u mjesečnoj dozi od 250 mg bio barem jednako učinkovit kao anastrozol u smislu preživljenja bez progresije bolesti, objektivnog odgovora i vremena do smrti.
• Increase of bilirubin (bile pigment produced by the liver)
• povišene vrijednosti bilirubina (žučnog pigmenta koji proizvodi jetra)
Patients enrolled in this study had a median age of 63 years (range 36-90).
Bolesnice uključene u ovo ispitivanje imale su medijan dobi od 63 godine (raspon: 36 - 90).
Fulvestrant blocks the trophic actions of estrogens without any partial agonist (estrogen-like) activity.
Fulvestrant blokira trofičko djelovanje estrogena, a da sam nema nikakvog djelomično agonističkog (estrogenu sličnog) djelovanja.
A total of 17.1% of patients received a prior chemotherapy regimen for advanced disease; 84.2% of patients had measurable disease.
Ukupno je 17,1% bolesnica prethodno primilo kemoterapijski protokol za uznapredovalu bolest; 84,2% bolesnica imalo je mjerljivu bolest.
Progression-Free Survival Probability (%)
Vjerojatnost preživljenja bez progresije bolesti (%)
The mechanism of action is associated with downregulation of estrogen receptor protein levels.
Mehanizam djelovanja povezan je sa snižavanjem razine proteina estrogenskih receptora.
Faslodex contains the active substance fulvestrant, which belongs to the group of estrogen blockers.
Faslodex sadržava djelatnu tvar fulvestrant, koja pripada skupini blokatora estrogena.