natgillin/translations-raw huggingface dataset:
Clinical safety and efficacy in advanced breast cancer Two phase III clinical trials were completed in a total of 851 postmenopausal women with advanced breast cancer who had disease recurrence on or after adjuvant endocrine therapy or progression following endocrine therapy for advanced disease.
Zaključeni sta bili dve klinični preskušanji III. faze na skupno 851 ženskah po menopavzi z napredovalim rakom dojke, pri katerih se je bolezen ponovila med ali po adjuvantnem endokrinem zdravljenju ali pa je prišlo do poslabšanja bolezni po endokrinem zdravljenju napredovale bolezni.
77% of the study population had estrogen receptor positive breast cancer.
V skupini bolnic, ki so sodelovale v študiji, jih je 77% imelo rak dojke s pozitivnimi estrogenskimi receptorji.
These trials compared the safety and efficacy of monthly administration of 250 mg fulvestrant versus the daily administration of 1 mg anastrozole (aromatase inhibitor).
V preskušanjih so primerjali varnost in učinkovitost uporabe 250 mg fulvestranta enkrat mesečno v primerjavi z enkrat dnevnim odmerkom, 1 mg anastrozola (zaviralcem aromataze).
Overall, fulvestrant at the 250 mg monthly dose was at least as effective as anastrozole in terms of time to progression, objective response, and time to death.
V celoti je bil fulvestrant v mesečnem odmerku 250 mg vsaj tako učinkovit kot anastrozol v smislu časa do napredovanja bolezni, objektivnega odgovora in časa do nastopa smrti.
Time to progression was the primary endpoint.
Primarni končni cilj je bil čas do napredovanja bolezni.
Combined analysis of both trials showed that 83% of patients who received fulvestrant progressed, compared with 85% of patients who received anastrozole.
Kombinirane analize obeh preskušanj so pokazale, da je do napredovanja bolezni prišlo pri 83% bolnic, ki so prejemale fulvestrant, v primerjavi s 85% bolnic, ki so prejemale anastrozol.
The hazard ratio of fulvestrant to anastrozole for time to progression was 0.95 (95% CI 0.82 to 1.10).
Razmerje tveganja med fulvestrantom in anastrozolom v času do napredovanja bolezni je bilo 0, 95 (95% CI 0, 82 do 1, 10).
The objective response rate for fulvestrant was 19.2% compared with 16.5% for anastrozole.
Objektivni delež odgovorov je bil za fulvestrant 19, 2% v primerjavi s 16, 5% pri anastrozolu.
The median time to death was 27.4months for patients treated with fulvestrant and 27.6 months for patients treated with anastrozole.
Mediana časa do nastopa smrti je bila 27, 4 mesecev pri bolnicah, ki so se zdravile s fulvestrantom, in 27, 6 mesecev pri bolnicah, ki so se zdravile z anastrozolom.
The hazard ratio of fulvestrant to anastrozole for time to death was 1.01 (95% CI 0.86 to 1.19).
Razmerje tveganja med fulvestrantom in anastrozolom glede časa do nastopa smrti je bilo 1, 01 (95% CI 0, 86 do 1, 19).
Analysis of results by ER status showed that the use of fulvestrant should be restricted to patients with ER positive breast cancer.
Analiza podatkov glede statusa ER je pokazala, da je treba uporabo fulvestranta omejiti na bolnice, ki imajo rak dojke s pozitivnimi estrogenskimi receptorji.
Effects on the postmenopausal endometrium Preclinical data do not suggest a stimulatory effect of fulvestrant on the postmenopausal endometrium (see section 5.3).
Predklinični podatki ne kažejo na stimulatorni učinek fulvestranta na endometrij po menopavzi (glejte poglavje 5. 3).
A 2-week study in healthy postmenopausal volunteers treated with 20 μ g per day ethinylestradiol showed that pre-treatment with 250 mg fulvestrant resulted in significantly reduced stimulation of the postmenopausal endometrium, compared to pre-treatment with placebo, as judged by ultrasound measurement of endometrium thickness
V 2- tedenski študiji na zdravih prostovoljkah po menopavzi, ki so prejemale 20 mikrogramov etinilestradiola dnevno, so ugotovili, da je predhodno zdravljenje z 250 mg fulvestranta vodilo k pomembnemu zmanjšanju stimulacije endometrija po menopavzi, v primerjavi s predhodnim zdravljenjem s placebom, kar je bilo ocenjeno z ultrazvočnim merjenjem debeline endometrija.
No data are available regarding endometrial morphology.
Ni podatkov o dolgoročnih učinkih fulvestranta na endometrij po menopavzi, na voljo pa ni tudi podatkov o morfologiji endometrija.
In two short-term studies (1 and 12 weeks) with premenopausal patients with benign gynaecologic disease, no significant differences in endometrial thickness were observed by ultrasound measuring between fulvestrant and placebo groups.
Učinki na kosti:
Effects on bone There are no long-term data on the effect of fulvestrant on bone.
Dolgoročnih podatkov o učinku fulvestranta na kosti ni na voljo.
5.2 Pharmacokinetic properties
5 5. 2 Farmakokinetične lastnosti
Absorption After administration of Faslodex long-acting as an intramuscular injection, fulvestrant is slowly absorbed and maximum plasma concentrations (Cmax) are reached after about 7 days.
Absorpcija Po aplikaciji dolgodelujoče intramuskularne injekcije zdravila Faslodex se fulvestrant počasi absorbira in doseže največje plazemske koncentracije (cmax) po okoli 7 dneh.
Absorption continues for over one month, and monthly administration results in an approximate 2-fold accumulation.
Absorpcija se nadaljuje več kot en mesec, mesečna uporaba pa ima za posledico približno 2- kratno akumulacijo.
Steady-state levels are reached after about 6 monthly injections, with the major part of the accumulation achieved after 3-4 doses.
Med mesečnimi injekcijami doseže koncentracije v stanju dinamičnega ravnovesja po 6 odmerkih, glavni del akumulacije pa je dosežen po 3- 4 odmerkih.
At steady state, fulvestrant plasma concentrations are maintained within a relatively narrow range with approximately 2- to 3-fold difference between maximum and trough concentrations.
V stanju dinamičnega ravnovesja se plazemske koncentracije fulvestranta ohranjajo v relativno ozkem območju s približno 2 - do 3- kratno razliko med najvišjimi in najnižjimi koncentracijami.
After intramuscular administration, the exposure is approximately dose-proportional in the dose range 50 to 250 mg.
Po intramuskularni aplikaciji je izpostavljenost približno sorazmerna z odmerkom v območju odmerkov od 50 do 250 mg.
Distribution Fulvestrant is subject to extensive and rapid distribution.
Porazdelitev Fulvestrant se obsežno in hitro porazdeli.
The large apparent volume of distribution at steady state (Vdss) of approximately 3 to 5 l/ kg suggests that distribution is largely extravascular.
Velik navidezni volumen porazdelitve v stanju dinamičnega ravnovesja (Vdss) (približno 3 do 5 l/ kg) kaže, da je porazdelitev predvsem ekstravaskularna.
Fulvestrant is highly (99%) bound to plasma proteins.
Fulvestrant se v velikem obsegu (99%) veže na plazemske proteine.
Very low density lipoprotein (VLDL), low 5 density lipoprotein (LDL), and high density lipoprotein (HDL) fractions are the major binding components.
Frakcije lipoproteinov zelo nizke gostote (VLDL), lipoproteinov nizke gostote (LDL) in lipoproteinov visoke gostote (HDL) so glavne komponente za vezavo.
Metabolism 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.
Presnova Presnova fulvestranta še ni popolnoma poznana, vendar pa vključuje kombinacije številnih možnih poti biotransformacije, analognih tistim za endogene steroide..
Identified metabolites (includes 17-ketone, sulphone, 3-sulphate, 3- and 17-glucuronide metabolites) are either less active or exhibit similar activity to fulvestrant in anti-estrogen models.
Znani presnovki (vključno s 17- ketoni, sulfoni, 3- sulfati, 3 - in 17- glukuronidnimi presnovki) so lahko manj aktivni ali pa v modelih z antiestrogeni izkazujejo podobno aktivnost kot fulvestrant.
Studies using human liver preparations and recombinant human enzymes indicate that CYP3A4 is the only P450 isoenzyme involved in the oxidation of fulvestrant; however, non-P450 routes appear to be more predominant in vivo.
V študijah so z uporabo preparatov jeter človeka in rekombinantnih humanih encimov pokazali, da je CYP 3A4 edini izoencim P- 450, ki sodeluje pri oksidaciji fulvestranta, čeprav se zdi, da in vivo prevladujejo poti, ki ne vključujejo P- 450.
Elimination Fulvestrant is eliminated mainly in metabolised form.
Izločanje Fulvestrant se izloča predvsem v presnovljeni obliki.
The major route of excretion is via the faeces, with less than 1% being excreted in the urine.
Glavna pot izločanja je z blatom, z urinom se ga izloči manj kot 1%.
Fulvestrant has a high clearance, 11±1.7 ml/ min/ kg, suggesting a high hepatic extraction ratio.
Fulvestrant ima visok očistek 11 ± 1, 7 ml/ min/ kg, kar kaže na visoko jetrno ekstrakcijsko razmerje.
The terminal half-life (t1/ 2) after intramuscular administration is governed by the absorption rate and was estimated to be 50 days.
Končen razpolovni čas (t1/ 2) po intramuskularnem odmerku določa hitrost absorpcije, in je bil ocenjen na 50 dni.
Special populations In a population pharmacokinetic analysis of data from phase III studies, no difference in fulvestrant’ s pharmacokinetic profile was detected with regard to age (range 33 to 89 years), weight (40-127 kg) or race.
Posebne skupine bolnic V populacijskih farmakokinetičnih analizah podatkov iz študij III. faze niso ugotovili nobenih razlik v farmakokinetičnih profilih fulvestranta glede na starost (območje od 33 do 89 let), maso (40- 127 kg) ali raso.
Renal impairment Mild to moderate impairment of renal function did not influence the pharmacokinetics of fulvestrant to any clinically relevant extent.
Ledvična okvara Blago do zmerno poslabšanje ledvične funkcije ni vplivalo na farmakokinetiko fulvestranta v klinično pomembnem obsegu.
Hepatic impairment The pharmacokinetics of fulvestrant has been evaluated in a single-dose clinical trial conducted in subjects with mild to moderate hepatic impairment (Child-Pugh class A and B).
Jetrna okvara Farmakokinetika fulvestranta je bila vrednotena v klinični raziskavi z enkratnim odmerkom pri preiskovancih z blago do zmerno jetrno okvaro (A in B stopnjo po Child – Pughovi klasifikaciji).
There was up to about 2.5-fold increase in AUC in subjects with hepatic impairment compared to healthy subjects.
Pri preiskovancih z jetrno okvaro se je povečal AUC za približno 2, 5- krat v primerjavi z zdravimi preiskovanci.
Local reactions, including myositis and granulomatoma at the injection site were attributed to the vehicle but the severity of myositis in rabbits increased with fulvestrant, compared to the saline control.
Lokalne reakcije na mestu injiciranja, vključno z miozitisom in granulomatomom, so pripisali vehiklu, vendar pa je resnost miozitisa pri kuncih večja pri fulvestrantu v primerjavi s kontrolno raztopino natrijevega klorida.
In toxicity studies with multiple intramuscular doses of fulvestrant in rats and dogs, the anti-estrogenic 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.
V študijah toksičnosti na podganah in psih s ponavljajočimi intramuskularnimi odmerki fulvestranta je bilo njegovo antiestrogeno delovanje odgovorno za večino opaženih učinkov, posebej na reprodukcijskem sistemu samic, pa tudi na drugih organih, občutljivih na hormone pri obeh spolih.
In dog studies following oral and intravenous administration, effects on the cardiovascular system (slight elevations of the S-T segment of the ECG [oral], and sinus arrest in one dog [intravenous]) were seen.
V študijah na psih po peroralni in intravenski uporabi so opazili učinke na kardiovaskularni sistem (rahlo povečanje S- T segmenta v EKG [peroralno] in sinusni zastoj pri enem psu [intravensko]).
These occurred at exposure levels higher than in patients (Cmax > 40 times) and are likely to be of limited significance for human safety at the clinical dose.
Ti so se pojavili pri višjih koncentracijah izpostavljenosti, kot so bile pri bolnicah (Cmax > 40- krat), in imajo verjetno omejen pomen za varnost pri ljudeh ob kliničnih odmerkih.
Fulvestrant showed effects upon reproduction and embryo/ foetal development consistent with its anti-estrogenic activity, at doses similar to the clinical dose.
Fulvestrant je pokazal učinke na reprodukcijo in razvoj zarodka/ ploda, ki so v skladu z njegovim antiestrogenim delovanjem v odmerkih, podobnih kliničnim.
Increases in
Kunci, ki so prejemali fulvestrant, niso mogli ohraniti brejosti.
6 placental weight and post-implantation loss of foetuses were seen.
Opazili so povečanje mase placente in izgubo ploda po ugnezdenju.
A two-year oncogenicity study in rats (intramuscular administration of Faslodex) showed increased incidence of ovarian benign granulosa cell tumours in female rats at the high dose, 10 mg/ rat/ 15 days and an increased incidence of testicular Leydig cell tumours in males.
Dvoletna študija onkogenosti pri podganah (intramuskularna aplikacija zdravila Faslodex) je pokazala povečano pogostnost pojavljanja benignih tumorjev granuloznih celic ovarija pri podganjih samicah pri visokih odmerkih 10 mg/ podgano/ 15 dni in povečano pogostnost pojavljanja tumorjev Leydigovih celic testisov pri samcih.
Induction of such tumours is consistent with pharmacology-related endocrine feedback alterations.
Indukcija tovrstnih tumorjev je v skladu s farmakološko povezanimi spremembami endokrine povratne zanke.
These findings are not of clinical relevance for the use of fulvestrant in postmenopausal women with advanced breast cancer.
Ta odkritja nimajo kliničnega pomena za uporabo fulvestranta pri ženskah po menopavzi z napredovalim rakom dojke.
Ethanol (96 per cent) Benzyl alcohol Benzyl benzoate Castor oil
Etanol, 96 odstotni Benzilalkohol Benzilbenzoat Ricinusovo olje
6.4 Special precautions for storage
7 6. 4 Posebna navodila za shranjevanje
Store in a refrigerator (2°C - 8°C).
Shranjujte v hladilniku (2°C - 8°C)..
One clear type 1 glass pre-filled syringe with polystyrene plunger rod, fitted with a tamper-evident closure, containing 5 ml solution for injection.
Ena napolnjena injekcijska brizga iz prozornega stekla tipa 1 s polistirenskim potisnim batom z zaporko, ki ščiti pred posegom, vsebuje 5 ml raztopine za injekcije.
A safety needle (SafetyGlide) for connection to the barrel is also provided.
Priložena je tudi varnostna igla (SafetyGlide) za povezavo z valjem.
Instructions for administration Remove glass syringe barrel from tray and check that it is not damaged.
Navodila za uporabo Odstranite stekleni valj injekcijske brizge iz podstavka in preverite, da ni poškodovan.
Peel open the safety needle (SafetyGlide) outer packaging.
Odstranite zunanjo ovojnino z varnostne igle (SafetyGlide).
(For safety needle instructions see below).
(Za navodila o uporabi varnostne igle glejte spodaj).
Break the seal of the white plastic cover on the syringe Luer connector to remove the cover with the attached rubber tip cap (see Figure 1).
Prelomite pečat belega plastičnega pokrovčka na Luerjevem spojniku injekcijske brizge, da odstranite pokrovček skupaj s pritrjeno gumijasto zaporko za konico (glejte sliko 1).
Twist to lock the needle to the Luer connector.
Zavrtite, da pritrdite iglo k Luerjevem konektorju.
Remove needle sheath.
Odstranite zaščito igle.
Parenteral solutions must be inspected visually for particulate matter and discolouration prior to administration.
Parenteralne raztopine morate pred uporabo vizualno pregledati zaradi možnosti prisotnosti delcev in spremembe barve.
Remove excess gas from the syringe (a small gas bubble may remain).
Odstranite presežek plina iz injekcijske brizge (majhen mehurček plina lahko ostane).
Administer intramuscularly slowly into the buttock.
Počasi intramuskularno aplicirajte v zadnjico.
Immediately activate needle protection device upon withdrawal of the needle from patient by pushing lever arm completely forward until needle tip is fully covered (see Figure 2).
Takoj ko izvlečete iglo iz bolnice aktivirajte pripomoček za zaščito igle tako, da potisnete vzvodno ročico povsem naprej, dokler ni konica igle popolnoma pokrita (glejte sliko 2).
Visually confirm that the lever arm has fully advanced and the needle tip is covered.
Dobro poglejte in se prepričajte, da je vzvodna ročica povsem naprej in da je konica igle pokrita.
If unable to activate the safety needle, discard immediately into an approved sharps collector.
Če ne morete aktivirati varnostne igle, takoj zavrzite v primeren zbiralnik za ostre predmete.
7 SafetyGlide Information from Becton Dickinson WARNING: - Do not autoclave safety needle before use.
Informacije Becton Dickinsona o SafetyGlide
Hands must remain behind the needle at all times during use and disposal.
OPOZORILO: - Pred uporabo ne avtoklavirajte varnostne igle.
Directions for Use of safety needle 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.
Transport filled syringe to point of administration.
Prenesite napolnjeno injekcijsko brizgo k mestu aplikacije.
Pull shield straight off needle to avoid damaging needle point.
Potegnite zaščito naravnost z igle, da se izognite poškodbi konice igle.
Administer injection following package instruction.
Injicirajte v skladu z navodili v zloženki.
For user convenience, the needle ‘ bevel up’ position is orientated to the lever arm, as shown in Figure 3.
Za prijaznost uporabniku je ‘ navzgor obrnjen poševni del ’ igle usmerjen k vzvodni ročici, kot kaže slika 3.
Immediately activate needle protection device upon withdrawal from patient by pushing lever arm completely forward until needle tip is fully covered (Figure 2).
Takoj ko izvlečete iglo iz bolnice aktivirate pripomoček za zaščito igle tako, da potisnete vzvodno ročico povsem naprej, dokler ni igla popolnoma pokrita (slika 2).
If unable to activate, discard immediately into an approved sharps collector.
Če je ne morete aktivirati, takoj zavrzite v primerne zbiralce za ostre predmete.
Activation of the protective mechanism may cause minimal splatter of fluid that may remain on the needle after injection.
8 Aktivacija zaščitnega mehanizma lahko povzroči manjši brizgljaj tekočine, ki lahko ostane na igli po injiciranju.
For greatest safety, use a one-handed technique and activate away from self and others.
Za kar največjo varnost izvajajte tehniko z eno roko in aktivirajte obrnjeno stran od sebe in drugih.
Disposal Pre-filled syringes are for single use only.
Odstranjevanje Napolnjene injekcijske brizge so za enkratno uporabo.
8 7.
9 8.
MARKETING AUTHORISATION HOLDER AstraZeneca UK Limited Alderley Park Macclesfield Cheshire SK10 4TG United Kingdom 8.
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET
10 March 2004 Date of last renewal:
10. marec 2004 Datum podaljšanja dovoljenja za promet:
DATE OF REVISION OF THE TEXT 9 ANNEX II
DATUM ZADNJE REVIZIJE BESEDILA
10 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
10 DODATEK II
B CONDITIONS OF THE MARKETING AUTHORISATION
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
11 ANNEX III
11 A IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
LABELLING AND PACKAGE LEAFLET
Izdaja zdravila je le na recept.
CARTON
14 PODATKI NA ZUNANJI IN STIČNI OVOJNINI ŠKATLICA
Ethanol (96 per cent), benzyl alcohol, benzyl benzoate and castor oil.
Etanol, 96 odstotni, benzilalkohol, benzilbenzoat in ricinusovo olje.
1 pre-filled syringe (5 ml) 1 safety needle (SafetyGlide)
1 varnostna igla (SafetyGlide).
For full instructions on the administration of Faslodex and the use of the safety needle see enclosed Instructions for Use.
Za celotna navodila glede uporabe zdravila Faslodex in uporabe varnostne igle glejte priložena navodila za uporabo.
AstraZeneca UK Limited Alderley Park Macclesfield Cheshire SK10 4TG United Kingdom
AstraZeneca UK Limited Alderley Park Macclesfield Cheshire SK10 4TG Velika Britanija
15 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
16 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Faslodex 250 mg solution for injection fulvestrant IM use
Faslodex 250 mg raztopina za injiciranjefulvestrant i. m. uporaba
Faslodex 250 mg solution for injection Fulvestrant
18 NAVODILO ZA UPORABO Faslodex 250 mg raztopina za injiciranje fulvestrant
What Faslodex is and what it is used for 2.
Kaj je zdravilo Faslodex in za kaj ga uporabljamo 2.
Before you use Faslodex 3.
3.
How to use Faslodex 4.
Kako uporabljati zdravilo Faslodex 4.
How to store Faslodex 6.
Shranjevanje zdravila Faslodex 6.
WHAT FASLODEX IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO FASLODEX IN ZA KAJ GA UPORABLJAMO
Estrogens, a type of female sex hormones, can in some cases be involved in the growth of breast cancer.
Estrogeni so ženski spolni hormoni, ki so lahko v nekaterih primerihpovezani z rastjo raka dojke.
BEFORE YOU USE FASLODEX
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO FASLODEX
Do not use Faslodex
Ne uporabljajte zdravila Faslodex
- if you are allergic (hypersensitive) to fulvestrant or to any of the other ingredients of Faslodex
- če ste alergični (preobčutljivi) na fulvestrant ali katero koli sestavino zdravila Faslodex (glejte
(listed in section 6 ‘ What Faslodex contains’)
poglavje 6 Kaj vsebuje zdravilo Faslodex);
- if you are pregnant or breast-feeding
- če ste noseči ali dojite;
- if you have severe liver problems
- če imate resne težave z jetri.
Take special care with Faslodex Tell your doctor if any of these apply to you:
Bodite posebno pozorni pri uporabi zdravila Faslodex Povejte svojemu zdravniku, če se karkoli od naštetega nanaša na vas:
- kidney or liver problems
- če imate težave z ledvicami ali jetri;
- low numbers of platelets (which help blood clotting) or bleeding disorders
- če imate nizko število trombocitov (pomagajo pri strjevanju krvi), ali motnje, povezane s
- previous problems with blood clots
- če ste imeli težave s krvnimi strdki;
- osteoporosis (loss of bone density)
- osteoporoza (zmanjšanje mineralne gostote kosti);
- Alcoholism
- alkoholizem.
Using other medicines Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Obvestite svojega zdravnika, medicinsko sestro ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
In particular, you should tell your doctor if you are using anticoagulants (medicines to prevent blood clots).
Povejte svojemu zdravniku, če uporabljate antikoagulante (zdravila, ki preprečujejo nastanek krvnih strdkov).
Pregnancy and breast-feeding You must not use Faslodex if you are pregnant.
Nosečnost in dojenje Ne smete jemati zdravila Faslodex, če ste noseči.
If you can become pregnant, you should use effective contraception while being treated with Faslodex.
Če lahko postanete noseči, morate med zdravljenjem z zdravilom Faslodex uporabljati učinkovito kontracepcijo.
You must not breast-feed while on treatment with Faslodex.
Ne smete dojiti, če se zdravite z zdravilom Faslodex.
However, if you feel tired after treatment do not drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Pri zdravilu Faslodex ni pričakovati vpliva na vašo sposobnost za vožnjo ali upravljanje s stroji, Če boste po zdravljenju občutili utrujenost, ne vozite ali upravljajte s stroji.
Important information about some of the ingredients of Faslodex
Pomembne informacije o nekaterih sestavinah zdravila Faslodex
This medicinal product contains 10% w/ v ethanol (alcohol), i. e. up to 500 mg per dose, equivalent to 10 ml beer or 4 ml wine per dose.
To zdravilo vsebuje 10% m/ v etanola (alkohola), to je do 500 mg na odmerek, kar ustreza 10 mg piva oziroma 4 ml vina na odmerek.
HOW TO USE FASLODEX
KAKO UPORABLJATI ZDRAVILO FASLODEX
The usual dose is 250 mg fulvestrant (one 5 ml injection) given once a month.
Običajni odmerek je 250 mg fulvestranta (ena 5 ml injekcija) enkrat na mesec.