natgillin/translations-raw huggingface dataset:
The recommended dose is 500 mg fulvestrant (two 250 mg/5 ml injections) given once a month, with an additional 500 mg dose given 2 weeks after the initial dose.
Priporočeni odmerek je 500 mg fulvestranta (dve injekciji 250 mg/5 ml) enkrat na mesec z dodatnim 500 mg odmerkom, uporabljenim 2 tedna po začetnem odmerku.
Secondary end points* OR [% (95% CI)] OR (measurable disease) [% (95% CI)]
Sekundarni cilji študije* OR [% (95 % IZ)] OR (merljiva bolezen) [% (95 % IZ)] CBR [% (95 % IZ)]
Severe hepatic impairment (see sections 4.4 and 5.2).
Huda okvara jeter (glejte poglavji 4.4 in 5.2).
Includes adverse drug reactions for which the exact contribution of Faslodex cannot be assessed due to the underlying disease.
Vključno z neželenimi učinki glede katerih, zaradi osnovne bolezni, ni mogoče natančno ugotoviti prispevka zdravila Faslodex.
• Numbness, tingling and pain
• omrtvičenost, mravljinčenje in bolečina
Combined analysis of both studies showed the hazard ratio of Faslodex 250 mg to anastrozole for progression-free survival was 0.95 (95% CI 0.82 to 1.10).
Kombinirana analiza obeh študij je pokazala razmerje ogroženosti za preživetje brez napredovanja bolezni med zdravilom Faslodex 250 mg in anastrozolom 0,95 (95 % IZ 0,82 do 1,10).
Faslodex should be administered as two consecutive 5 ml injections by slow intramuscular injection (1-2 minutes/injection), one in each buttock (gluteal area).
Zdravilo Faslodex je treba dati v dveh zaporednih injekcijah po 5 ml; injicirati ju je treba počasi (1-2 min/injekcijo) intramuskularno, eno injekcijo v vsak glutealni predel.
• Administer intramuscularly slowly (1-2 minutes/injection) into the buttock (gluteal area).
• Počasi (1-2 minuti/injekcijo) injicirajte intramuskularno v glutealni predel.
Do not use this medicine after the expiry date which is stated on the carton or syringe labels after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na injekcijski brizgi poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Joint and musculoskeletal pain
Sklepna in mišično-skeletna bolečina
These studies compared the safety and efficacy of monthly administration of Faslodex 250 mg versus the daily administration of 1 mg anastrozole (aromatase inhibitor).
V študijah so primerjali varnost in učinkovitost uporabe zdravila Faslodex 250 mg enkrat mesečno v primerjavi z enkrat dnevnim odmerkom, 1 mg anastrozola (zaviralec aromataze).
Listen for click and visually confirm needle tip is fully covered.
Slišati morate klik in nato pregledati, ali je konica igle povsem pokrita.
• Nausea (feeling sick)
• navzea (občutek slabosti v želodcu)
Faslodex should be used with caution in patients with mild to moderate hepatic impairment (see sections 4.2, 4.3 and 5.2).
Zdravilo Faslodex uporabljajte previdno pri bolnicah z blago do zmerno okvaro jeter (glejte poglavja 4.2, 4.3 in 5.2).
• as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: - not previously treated with endocrine therapy, or - with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy.
• kot samostojno zdravljenje lokalno napredovalega ali metastatskega raka dojke s pozitivnimi estrogenskimi receptorji pri ženskah po menopavzi: - ki predhodno niso bile zdravljene z endokrinim zdravljenjem, ali - z recidivom bolezni med ali po adjuvantnem zdravljenju z antiestrogeni ali ob napredovanju bolezni med zdravljenjem z antiestrogeni.
This was evident for pre/perimenopausal women (HR of 0.46 [95% CI: 0.28, 0.75]) and postmenopausal women (HR of 0.52 [95% CI: 0.40, 0.66]) and patients with visceral site of metastatic disease (HR of 0.50 [95% CI: 0.38, 0.65]) and non-visceral site of metastatic disease (HR of 0.48 [95% CI: 0.33, 0.71]).
To je bilo opazno pri ženskah pred menopavzo ali v perimenopavzi (HR 0,46 [95 % IZ: 0,28; 0,75]) ter pri ženskah po menopavzi HR 0,52 [95 % IZ: 0,40; 0,66]), prav tako tudi pri bolnicah z visceralno metastatsko boleznijo (HR 0,50 [95 % IZ: 0,38; 0,65]) ali z nevisceralno metastatsko boleznijo (HR 0,48 [95 % IZ: 0,33; 0,71]).
A Phase 3, randomised, double-blind, double-dummy, multicentre study of Faslodex 500 mg versus anastrozole 1 mg was conducted in postmenopausal women with ER-positive and/or PgR-positive locally advanced or metastatic breast cancer who had not previously been treated with any hormonal therapy.
Izvedena je bila randomizirana, dvojno slepa, dvojno s placebom primerjana, multicentrična študija 3. faze, ki je primerjala zdravilo Faslodex 500 mg z 1 mg anastrozola, pri ženskah po menopavzi z ER-pozitivnim in/ali PgR-pozitivnim lokalno napredovalim ali metastatskim rakom dojke, ki predhodno niso bile zdravljene z nobenim hormonskim zdravljenjem.
The most common (≥2%) Grade ≥3 adverse reactions were neutropenia, leukopenia, anaemia, infections, AST increased, thrombocytopenia, and fatigue.
Najpogostejši (≥ 2 %) neželeni učinki ≥ 3. stopnje so bili nevtropenija, levkopenija, anemija, okužbe, zvišana vrednost AST, trombocitopenija in utrujenost.
Your doctor or nurse will give you Faslodex as a slow intramuscular injection, one into each of your buttocks.
Zdravilo Faslodex vam bo dal zdravnik ali medicinska sestra z dvema počasnima injekcijama v mišico, po eno injekcijo v vsako stran zadnjice.
In patients administered Faslodex, an increase in exposure of this magnitude is expected to be well tolerated.
Pri bolnicah, ki so prejemale zdravilo Faslodex, je pričakovana dobra sposobnost prenašanja pri povečanju izpostavljenosti v tem obsegu.
Caution should be taken if injecting Faslodex at the dorsogluteal site due to the proximity of the underlying sciatic nerve.
V primeru injiciranja zdravila Faslodex v dorzoglutealni predel je potrebna previdnost zaradi bližine spodaj potekajočega ishiadičnega živca.
Benefit was also observed regardless of lines of prior therapy in the metastatic setting, whether 0 (HR of 0.59 [95% CI: 0.37, 0.93]), 1 (HR of 0.46 [95% CI: 0.32, 0.64]), 2 (HR of 0.48 [95% CI: 0.30, 0.76]), or ≥3 lines (HR of 0.59 [95% CI: 0.28, 1.22]).
Korist so opažali tudi ne glede na število linij predhodnega zdravljenja metastatske bolezni, naj je bilo to 0 (HR 0,59 [95 % IZ: 0,37; 0,93]), 1 (HR 0,46 [95 % IZ: 0,32; 0,64]), 2 (HR 0,48 [95 % IZ: 0,30; 0,76]) ali ≥ 3 linije (HR 0,59 [95 % IZ: 0,28; 1,22]).
In the fulvestrant + placebo arm (n=172), neutropenia of any grade was reported in 7 (4.1%) patients, with Grade 3 neutropenia reported in 1 (0.6%) patient.
V skupini, ki je prejemala fulvestrant in placebo, (n = 172) so o nevtropeniji (katere koli stopnje) poročali pri 7 (4,1 %) bolnicah in o nevtropeniji 3. stopnje pri 1 (0,6 %) bolnici.
NOTE: Due to the proximity of the underlying sciatic nerve, caution should be taken if administering Faslodex at the dorsogluteal injection site (see section 4.4).
OPOMBA: Zaradi bližine spodaj potekajočega ishiadičnega živca je v primeru injiciranja zdravila Faslodex v dorzoglutealni predel potrebna previdnost (glejte poglavje 4.4).
Neutropenia includes the following PTs: Neutropenia, Neutrophil count decreased.
Nevtropenija vključuje naslednja PTs: nevtropenija, zmanjšano število nevtrofilcev.
Faslodex contains 750 mg benzyl benzoate per injection, equivalent to 150 mg/ml.
Zdravilo Faslodex vsebuje 750 mg benzilbenzoata na injekcijo, kar je enako 150 mg/ml.
Table 5 Efficacy results - PALOMA3 study (Investigator assessment, intent-to-treat population)
Rezultati učinkovitosti - študija PALOMA3 (po oceni raziskovalca, vključeni bolniki)
Safety needles (BD SafetyGlide) for connection to each barrel are also provided.
Priloženi sta tudi varnostni igli (BD SafetyGlide) za povezavo z valjema.
A Phase 3 clinical study was completed in 736 postmenopausal women with advanced breast cancer who had disease recurrence on or after adjuvant endocrine therapy or progression following endocrine therapy for advanced disease.
Opravljena je bila klinična študija 3. faze pri 736 ženskah po menopavzi z napredovalim rakom dojke, ki se jim je bolezen ponovila med ali po adjuvantnem endokrinološkem zdravljenju, ali je napredovala po endokrinološkem zdravljenju napredovale bolezni.
In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.
Pri ženskah pred menopavzo ali v perimenopavzi je treba kombinirano zdravljenje s palbociklibom uporabljati skupaj z agonistom gonadoliberina (LHRH-Luteinizing Hormone Releasing Hormone).
was the primary endpoint; key secondary efficacy endpoints included objective response rate (ORR), clinical benefit rate (CBR) and overall survival (OS).
Glavni opazovani dogodek je bilo preživetje brez napredovanja bolezni (PFS - Progression-Free-Survival), ključni sekundarni opazovani dogodki učinkovitosti so vključevali objektivni delež odziva (ORR - Objective Response Rate), delež klinične koristi (CBR - Clinical Benefit Rate) in celotno preživetje (OS - Overall Survival).
Exposure to temperatures below 2°C will not damage the product providing it is not stored below -20°C.
Izpostavljenost temperaturam pod 2°C zdravilu ne bo škodovalo, pod pogojem, da ni shranjeno pri temperaturi pod -20 °C.
Interference with estradiol antibody assays
Moteči vpliv na preizkuse estradiola s protitelesi
• alone, to treat postmenopausal women with a type of breast cancer called estrogen receptor positive breast cancer that is locally advanced or has spread to other parts of the body (metastatic), or
• samo, za zdravljenje žensk po menopavzi s posebno vrsto raka dojke (t.i. rakom dojke s pozitivnimi estrogenskimi receptorji), ki je lokalno napredoval ali se je razširil v druge dele telesa (je metastatski), ali
Each pre-filled syringe (5 ml) contains 250 mg fulvestrant.
Ena napolnjena injekcijska brizga (5 ml) vsebuje 250 mg fulvestranta.
When Faslodex is used in combination with palbociclib, please also refer to the Summary of Product Characteristics of palbociclib.
Če je zdravilo Faslodex uporabljeno v kombinaciji s palbociklibom, glejte tudi Povzetek glavnih značilnosti za palbociklib.
In the pooled dataset of fulvestrant monotherapy, the most frequently reported adverse reactions were injection site reactions, asthenia, nausea, and increased hepatic enzymes (ALT, AST, ALP).
V kumulativnem naboru podatkov o samostojnim zdravljenju s fulvestrantom so bili najpogostejši neželeni učinki o katerih so poročali reakcije na mestu injiciranja, astenija, navzea in zvišanje jetrnih encimov (ALT, AST, ALP).
You must not breast-feed while on treatment with Faslodex.
Med zdravljenjem z zdravilom Faslodex ne smete dojiti.
An updated RMP should be submitted • At the request of the European Medicines Agency;
Posodobljen RMP je treba predložiti:
Faslodex is not expected to affect your ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Pri zdravilu Faslodex ni pričakovati vpliva na vašo sposobnost za vožnjo ali upravljanje strojev.
Arteritis involving a range of different tissues was seen in some dogs after chronic (12 months) dosing.
Pri nekaterih psih so po kronični uporabi (12 mesecev) opažali arteritis, ki je zajel celo vrsto različnih tkiv.
• Pull shield straight off needle to avoid damaging needle point.
• Potegnite ščitnik naravnost z igle, da ne boste poškodovali konice igle.
In the FALCON study, the number of patients who reported an adverse reaction of joint and musculoskeletal pain was 65 (31.2%) and 48 (24.1%) for fulvestrant and anastrozole arms, respectively.
V študiji FALCON je o neželenem učinku sklepna in mišično-skeletna bolečina poročalo 65 (31,2 %) bolnic v skupini s fulvestrantom in 48 (24,1 %) bolnic v skupini z anastrozolom.
The primary endpoint of the study was investigator-assessed PFS evaluated according to RECIST 1.1.
Primarni cilj študije je bilo preživetje brez napredovanja bolezni (PFS - Progression-Free Survival) po oceni raziskovalca, ocenjeno po merilih RECIST 1.1.
The paediatric patients received 4 mg/kg monthly intramuscular dose of fulvestrant.
Pediatrične bolnice so mesečno prejemale fulvestrant v intramuskularnem odmerku 4 mg/kg.
Faslodex is used either:
Zdravilo Faslodex se uporablja ali:
Stomatitis includes the following PTs: Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, Stomatitis.
Stomatitis vključuje naslednje PTs: aftozni stomatitis, heilitis, glositis, glosodinija, razjede v ustih, vnetje sluznice, bolečine v ustih, nelagodje v orofarinksu, bolečine v orofarinksu, stomatitis.
The most common (≥20%) adverse reactions of any grade reported in patients receiving fulvestrant in combination with palbociclib were neutropenia, leukopenia, infections, fatigue, nausea, anaemia, stomatitis, diarrhoea, and thrombocytopenia.
Najpogostejši (≥ 20 %) neželeni učinki katere koli stopnje, opisani pri bolnicah, ki so prejemale fulvestrant v kombinaciji s palbociklibom, so bili nevtropenija, levkopenija, okužbe, utrujenost, navzea, anemija, stomatitis, driska in trombocitopenija.
- The other ingredients (excipients) are ethanol (96 per cent), benzyl alcohol, benzyl benzoate and castor oil refined.
- Druge sestavine zdravila (pomožne snovi) so: etanol (96 odstotni), benzilalkohol, benzilbenzoat in rafinirano ricinusovo olje.
Two Phase 3 clinical studies 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 študiji 3. 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.
Neoadjuvant treatment for up to 16 weeks in breast cancer patients treated with either Faslodex 500 mg or Faslodex 250 mg did not result in clinically significant changes in endometrial thickness, indicating a lack of agonist effect.
Do 16 tednov trajajoče neoadjuvantno zdravljenje s 500 mg ali z 250 mg zdravila Faslodex pri bolnicah z rakom dojke ni klinično pomembno spremenilo debeline endometrija, kar kaže na odsotnost agonističnega učinka.
Rash includes the following PTs: Rash, Rash maculo-papular, Rash pruritic, Rash erythematous, Rash papular, Dermatitis, Dermatitis acneiform, Toxic skin eruption.
Izpuščaj vključuje naslednje PTs: izpuščaj, makulo-papulozen izpuščaj, pruritični izpuščaj, eritematozni izpuščaj, papulozni izpuščaj, dermatitis, akneiformni dermatitis, toksične erupcije na koži.
Kaplan-Meier plot of progression-free survival (investigator assessment, intent-to-treat population) - PALOMA3 study
Kaplan-Meierjev prikaz preživetja brez napredovanja bolezni (po oceni raziskovalca, vključeni bolniki) - študija PALOMA3
Figure 1 Kaplan-Meier Plot of Progression-Free Survival (Investigator Assessment, Intent-ToTreat Population) ─ FALCON Study
Kaplan-Meierjev prikaz preživetja brez napredovanja bolezni (po oceni raziskovalca, vključeni bolniki) ─ študija FALCON
Anaemia includes the following PTs: Anaemia, Haemoglobin decreased, Haematocrit decreased.
Anemija vključuje naslednje PTs: anemija, znižana vrednost hemoglobina, znižana vrednost hematokrita.
A total of 521 pre/peri- and postmenopausal women who had progressed on or within 12 months from completion of adjuvant endocrine therapy on or within 1 month from prior endocrine therapy for advanced disease, were randomised 2:1 to Faslodex plus palbociclib or Faslodex plus placebo and stratified by documented sensitivity to prior hormonal therapy, menopausal status at study entry (pre/peri- versus postmenopausal), and presence of visceral metastases.
Skupno 521 žensk pred menopavzo, v perimenopavzi ali po menopavzi, pri katerih je bolezen napredovala med ali v 12 mesecih po dokončanem adjuvantnem endokrinem zdravljenju ali med oziroma v 1 mesecu od predhodnega endokrinega zdravljenja za napredovalo bolezen, so v razmerju 2:1 randomizirali na kombinacijo zdravila Faslodex in palbocikliba ali na kombinacijo zdravila Faslodex in placeba.
This should be taken into consideration when prescribing Faslodex to patients at risk.
Pri predpisovanju zdravila Faslodex bolnicam s tovrstnim tveganjem je to potrebno upoštevati.
It has also been shown that fulvestrant 500 mg downregulates ER and the proliferation marker Ki67, to a greater degree than fulvestrant 250 mg in breast tumours in postmenopausal neoadjuvant setting.
Dokazano je tudi, da 500 mg fulvestranta pri tumorjih dojke med neoadjuvantno uporabo po menopavzi zmanjša število ER in proliferacijo označevalca Ki67 v večji meri kot 250 mg fulvestranta.
Neoadjuvant treatment for up to 16 weeks in breast cancer patients with either Faslodex 500 mg or Faslodex 250 mg did not result in clinically significant changes in serum bone-turnover markers.
Do 16 tednov trajajoče neoadjuvantno zdravljenje s 500 mg ali z 250 mg zdravila Faslodex pri bolnicah z rakom dojke ni klinično pomembno spremenilo označevalcev kostne premene v serumu.
Ethanol (96 per cent), benzyl alcohol, benzyl benzoate and castor oil refined.
Etanol (96 odstotni), benzilalkohol, benzilbenzoat in rafinirano ricinusovo olje.
2 pre-filled syringes (5 ml each) 2 safety needles
2 napolnjeni injekcijski brizgi (5 ml) 2 varnostni igli
• in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy (see section 5.1).
• v kombinaciji s palbociklibom za zdravljenje lokalno napredovalega ali metastatskega raka dojke s pozitivnimi hormonskimi receptorji (HR-Hormone Receptor) in negativnimi receptorji 2 za epidermalni rastni faktor (HER2-Human Epidermal growth factor Receptor 2) pri ženskah, ki so predhodno prejemale endokrino zdravljenje (glejte poglavje 5.1).
Table 3 Summary of results of the primary efficacy endpoint (PFS) and key secondary efficacy endpoints in the CONFIRM study
Povzetek rezultatov glavnega opazovanega dogodka in ključnih sekundarnih opazovanih dogodkov študije CONFIRM
Adverse reactions by system organ class and frequency Infections and infestations
Neželeni učinki glede na pogostnost in organski sistem Infekcijske in parazitske bolezni pogosti okužbe sečil
The term injection site reactions does not include the terms injection site haemorrhage, injection site haematoma, sciatica, neuralgia and neuropathy peripheral.
Izraz reakcije na mestu injiciranja ne vključuje izrazov krvavitev na mestu injiciranja, hematom na mestu injiciranja, išias, nevralgija in periferna nevropatija.
PFS Median [months (95% CI)] Number of OS Events* OS Hazard Ratio (95% CI) and p-value
Mediano PFS [meseci (95 % IZ)] Število dogodkov OS* Razmerje ogroženosti za OS (95 % IZ) in vrednost p
Table 1 Adverse Drug Reactions reported in patients treated with Faslodex monotherapy
Neželeni učinki zdravila, zabeleženi pri bolnicah, zdravljenih s samostojnim zdravljenjem z zdravilom Faslodex
One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution.
Ena napolnjena injekcijska brizga vsebuje 250 mg fulvestranta v 5 ml raztopine.
Leukopenia includes the following PTs: Leukopenia, White blood cell count decreased.
Levkopenija vključuje naslednja PTs: levkopenija, zmanjšano število levkocitov.
Faslodex and other formulations of fulvestrant were well tolerated in animal species used in multiple dose studies.
V študijah s ponavljajočimi odmerki so zdravilo Faslodex in druge oblike s fulvestrantom dobro prenašale vse živalske vrste.
There were no reports of Grade 4 neutropenia in the fulvestrant + placebo arm.
V skupini, ki je prejemala fulvestrant in placebo, ni bilo poročil o nevtropeniji 4. stopnje.
Progression-Free Survival Number of PFS Events (%) PFS Hazard Ratio (95% CI) and p-value
Preživetje brez napredovanja bolezni Število dogodkov PFS (%) Razmerje ogroženosti za PFS (95 % IZ) in vrednost p
Pre/perimenopausal women received the LHRH agonist goserelin.
Bolnice pred menopavzo in bolnice v perimenopavzi so dobile agonist LHRH goserelin.
Faslodex 250 mg solution for injection fulvestrant
Faslodex 250 mg raztopina za injiciranje fulvestrant
• Thick, whitish vaginal discharge and candidiasis (infection)
• gost, belkast izcedek iz nožnice in kandidiaza (glivična okužba nožnice)
What Faslodex contains - The active substance is fulvestrant.
Kaj vsebuje zdravilo Faslodex - Učinkovina je fulvestrant.
Increases in placental weight and post-implantation loss of foetuses were seen.
Opazili so povečanje mase placente in izgubo ploda po ugnezdenju.
All Patients -AE subgroup (n=423) -AI subgroup (n=313)
Vsi bolniki -AE podskupina (n = 423) -AI podskupina (n = 313)
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema zelo pogosti
Breast-feeding must be discontinued during treatment with Faslodex.
Med zdravljenjem z zdravilom Faslodex je potrebno opustiti dojenje.
Faslodex contains 500 mg benzyl alcohol per injection, equivalent to 100 mg/ml.
Zdravilo Faslodex vsebuje 500 mg benzilalkohola na injekcijo, kar je enako 100 mg/ml.
• Check that the needle is locked to the Luer connector before moving out of the vertical plane.
• Pred premikom iz navpične ravnine preverite, da je igla pričvrščena na nastavku Luer.
• in combination with palbociclib to treat women with a type of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer, that is locally advanced or has spread to other parts of the body (metastatic).
• v kombinaciji s palbociklibom za zdravljenje žensk z rakom dojke, imenovanim rak dojke s pozitivnimi hormonskimi receptorji in negativnimi receptorji 2 za epidermalni rastni faktor, ki je lokalno napredoval ali se je razširil v druge dele telesa (je metastatski).
Faslodex contains 10% w/v ethanol (alcohol), i.e. up to 500 mg per injection, equivalent to 10 ml beer or 4 ml wine.
Zdravilo Faslodex vsebuje 10 % m/v etanola (alkohola), to je do 500 mg na injekcijo, kar ustreza 10 ml piva oziroma 4 ml vina.
Mechanism of action and pharmacodynamic effects Fulvestrant is a competitive estrogen receptor (ER) antagonist with an affinity comparable to estradiol.
Fulvestrant je kompetitivni antagonist estrogenskih receptorjev z afiniteto, primerljivo z afiniteto estradiola.
Two clear type 1 glass pre-filled syringes with polystyrene plunger rod, fitted with a tamper-evident closure, each containing 5 ml Faslodex solution for injection.
Dve napolnjeni injekcijski brizgi iz prozornega stekla tipa 1 s polistirenskim potisnim batom z zaporko, ki ščiti pred posegom, vsaka vsebuje 5 ml Faslodex raztopine za injekcije.
For user convenience, the needle bevel-up position is oriented to the lever arm (see Figure 4).
Zaradi praktičnosti pri uporabi je prirezani del igle na strani ročice (glejte sliko 4).
All Patients -AE subgroup (n=423) -AI subgroup (n=313) OS
Vsi bolniki -AE podskupina (n = 423) -AI podskupina (n = 313) OS
Faslodex 250 mg solution for injection.
Faslodex 250 mg raztopina za injiciranje
• Parenteral solutions must be inspected visually for particulate matter and discolouration prior to administration.
• Parenteralne raztopine je treba pred uporabo pregledati in se prepričati, da ne vsebujejo delcev in da niso spremenjene barve.
Faslodex contains 10% w/v ethanol (alcohol) as an excipient, i.e. up to 500 mg per injection, equivalent to 10 ml beer or 4 ml wine.
Zdravilo Faslodex vsebuje 10 % m/v etanola (alkohola) kot pomožno snov, to je do 500 mg na injekcijo, kar ustreza 10 ml piva oziroma 4 ml vina.
• Decreased levels of platelets (thrombocytopenia)
• zmanjšanje števila trombocitov (trombocitopenija)
See package leaflet for information on temperature excursions.
Za informacije o temperaturnih odklonih glejte navodilo za uporabo.
Elevated hepatic enzymes (ALT, AST, ALP)
Bolezni jeter, žolčnika in žolčevodov zelo pogosti zvišanje jetrnih encimov (ALT, AST, ALP)
• Transport filled syringe to point of administration.
• Prenesite napolnjeno brizgo na mesto, kjer bo zdravilo uporabljeno.