natgillin/translations-raw huggingface dataset:
Repaglinide Accord has been shown to lower the blood sugar, which helps to prevent complications from your diabetes. 
Repaglinid Accord snižava razinu šećera u krvi i time pomaže u sprječavanju komplikacija šećerne bolesti.
Repaglinide Accord is available in the following pack sizes: 30, 90, 120, 180 or 270 tablets in blisters 
Repaglinid Accord je dostupan u sljedećim veličinama pakovanja: 30, 90, 120, 180 ili 270 tableta u blisterima
When a patient stabilised on any oral hypoglycaemic agent is exposed to stress such as fever, trauma, infection or surgery, a loss of glycaemic control may occur. 
Kada je bolesnik, u kojega se stanje stabiliziralo primjenom bilo kojeg oralnog antidijabetika, izložen stresu kao što je vrućica, trauma, infekcija ili operativni zahvat, može doći do poremećaja regulacije glikemije.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 December 2011 
DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA
No clinical studies have been conducted in patients with hepatic insufficiency. 
Nisu provedena klinička ispitivanja u bolesnika s insuficijencijom jetre.
How to take Repaglinide Accord 
Kako uzimati Repaglinid Accord
Co-administration of cimetidine, nifedipine, oestrogen, or simvastatin with repaglinide, all CYP3A4 substrates, did not significantly alter the pharmacokinetic parameters of repaglinide. 
Istodobna primjena supstrata CYP3A4, kao što su cimetidin, nifedipin, estrogen ili simvastatin, s repaglinidom nije značajno izmijenila farmakokinetičke parametre repaglinida.
• Hypersensitivity (such as rash, itchy skin, redening of the skin, swelling of the skin) 
Nepoznata učestalost • preosjetljivost (kao što je osip, svrbež kože, crvenilo kože, oticanje kože)
Aluminium/aluminium blister in packs containing 30, 90, 120, 180 or 270 tablets. 
Aluminij/aluminijski blister u pakovanjima koja sadrže 30, 90, 120, 180 ili 270 tableta.
• Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy) 
• fenitoin, karbamazepin, fenobarbital (koriste se za liječenje epilepsije)
Repaglinide Accord is not recommended in patients with moderate liver disease. 
Repaglinid Accord se ne preporučuje u bolesnika koji imaju srednje tešku bolest jetre.
Repaglinide Accord can also be given with metformin, another medicine for diabetes. 
Repaglinid Accord se može primjenjivati i u kombinaciji s metforminom, drugim lijekom protiv šećerne bolesti.
• The dose may be adjusted by your doctor by up to 4 mg to be taken immediately before or up to 
• Liječnik Vam može povećati dozu do 4 mg koju treba uzeti neposredno prije ili do 30 minuta prije svakog glavnog obroka.
Repaglinide closes ATP-dependent potassium channels in the β-cell membrane via a target protein different from other secretagogues. 
Repaglinid zatvara o ATP-u ovisne kalijeve kanale u membrani β-stanica vezanjem za protein koji je različit od proteina na koji se vezuju drugi lijekovi koji potiču lučenje inzulina.
Abnormal hepatic function, increased liver enzymes 
Poremećaji funkcije jetre, porast jetrenih enzima
Combination with Neutral Protamine Hagedorn (NPH) insulin or thiazolidinediones Trials of combination therapy with NPH insulin or thiazolidinediones have been performed. 
Kombinacija s Neutralnim Protamin Hagedorn (NPH) inzulinom ili tiazolidindionima
HDPE bottle containing 100 tablets in packs of 1 bottle. 
Jedna HDPE plastična bočica u pakiranju od 100 tableta.
Patients can be transferred directly from other oral hypoglycaemic medicinal products to repaglinide. 
Bolesnici mogu izravno prijeći na repaglinid s nekog drugog oralnog antidijabetika.
PARTICULARS TO APPEAR ONTHE IMMEDIATE PACKAGING HDPE BOTTLE 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU HDPE BOČICA
Isolated cases of increased liver enzymes have been reported during treatment with repaglinide. 
Tijekom liječenja repaglinidom zabilježeni su pojedinačni slučajevi porasta jetrenih enzima.
Tablet 100 tablets 
120 tableta
A dose-dependent decrease in blood glucose was demonstrated in type 2 diabetic patients when administered in doses from 0.5 to 4 mg repaglinide. 
U bolesnika sa šećernom bolešću tipa 2, sniženje razine glukoze u krvi ovisno o dozi lijeka potvrđeno je pri dozama repaglinida od 0,5 do 4 mg.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg of repaglinide. 
KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH TVARI Svaka tableta sadrži 1 mg repaglinida.
The recommended starting dose is 0.5 mg. One to two weeks should elapse between titration steps (as determined by blood glucose response). 
Između svakog koraka titracije doze trebalo bi proći jedan do dva tjedna (na temelju mjerenja razine glukoze u krvi).
• If you take too little Repaglinide Accord 
• ako uzmete premalo lijeka Repaglinid Accord
What you need to know before you take Repaglinide Accord Do not take Repaglinide Accord 
Što morate znati prije nego počnete uzimati Repaglinid Accord
You should not take Repaglinide Accord if you are breast-feeding. 
Ne smijete uzimati Repaglinid Accord ako dojite.
Very rare (may affect up to 1 in 10,000 patients) 
Vrlo rijetko (mogu se javiti u manje od 1 na 10 000 bolesnika)
Gastrointestinal disorders Abdominal pain, diarrhoea 
Poremećaji probavnog sustava Bol u trbuhu, proljev
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET
Repaglinide pharmacokinetics are characterised by low volume of distribution, 30 L (consistent with distribution into intracellular fluid), and is highly bound to plasma proteins in humans (greater than 
Farmakokinetika repaglinida karakterizirana je malim volumenom distribucije, 30 l (što je sukladno s distribucijom u unutarstaničnoj tekućini) i u velikom se postotku veže za proteine plazme u ljudi (više od 98%), te se brzo eliminira iz krvi.
• Thyroid products (used to treat low levels of thyroid hormones) 
• hormone štitnjače (koriste se za liječenje niske razine hormona štitnjače)
Repaglinide Accord 0.5 mg tablets Repaglinide Accord 1 mg tablets Repaglinide Accord 2 mg tablets Repaglinide 
Repaglinid Accord 0,5 mg tablete Repaglinid Accord 1 mg tablete
No clinical studies have been conducted in patients >75 years of age. 
Nisu provedena klinička ispitivanja u bolesnika u dobi
Talk to your doctor before taking Repaglinide Accord 
Upozorenja i mjere opreza Obratite se svom liječniku prije nego uzmete Repaglinid Accord:
Your blood sugar may get too high (hyperglycaemia). 
Ako razina šećera u krvi postane previsoka Razina šećera u krvi može biti previsoka (hiperglikemija).
Repaglinide, like other insulin secretagogues, is capable of producing hypoglycaemia. 
Repaglinid, kao i drugi lijekovi koji potiču lučenje inzulina, može izazvati hipoglikemiju.
Marketing authorisation holder and manufacturer Marketing authorisation holder Accord Healthcare S.L.U. 
Nositelj odobrenja za stavljanje gotovog lijeka u promet i proizvođač Nositelj odobrenja za stavljanje lijeka u promet
• If you take too much Repaglinide Accord 
• ako uzmete previše lijeka Repaglinid Accord
Half-life was prolonged from 1.3 hr to 3.7 hr, resulting in possibly enhanced and prolonged blood glucose-lowering effect of repaglinide, and plasma repaglinide concentration at 7 hr was increased 28.6-fold by gemfibrozil. 
Poluvijek je produljen s 1,3 na 3,7 sati, rezultirajući mogućim pojačanim i produljenim učinkom repaglinida na snižavanje razine glukoze u krvi.
In an interaction study with healthy volunteers, co-administration of deferasirox (30 mg/kg/day, 4 days), a moderate inhibitor of CYP2C8 and CYP3A4, and repaglinide (single dose, 0.5 mg) resulted in an increase in repaglinide systemic exposure (AUC) to 2.3-fold (90% CI [2.03-2.63]) of control, a 1.6-fold (90% CI [1.42-1.84])an increase in Cmax of 62%,, and a small, significant decrease in blood glucose values. 
U ispitivanju interakcija u zdravih dobrovoljaca, istodobna primjena deferasiroksa (30 mg/kg/dan, 4 dana), slabije umjerenog inhibitora CYP2C8 i CYP3A4 i repaglinida (pojedinačna doza od 0,5 mg) rezultirala je povećanjem sistemske izloženosti repaglinidu (AUC) za 2,3 puta (90% CI [2,03-2,63]) u odnosu na kontrolnu skupinu, povećanjem Cmax za 1,6 puta (90% CI [1,42-1,84]), što je 62%, te malim, ali značajnim sniženjem razine glukoze u krvi.
White to off white, round, biconvex with beveled edge, uncoated tablets, with inscription “R” on one side and plain on other side. 
Bijele do bjelkaste, okrugle, bikonveksne, neobložene tablete s ukošenim rubovima, s utisnutom oznakom „R“ na jednoj strani te bez oznaka na drugoj strani.
Repaglinide Accord should not be taken if you have a severe liver disease (see Do not take Repaglinide Accord). 
Repaglinid Accord ne smijete uzimati ako imate tešku bolest jetre
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.