natgillin/translations-raw huggingface dataset:
Section 2 “Before you take [product name]”:
Poglavje 2 „Kaj morate vedeti, preden boste vzeli zdravilo [ime zdravila]
“In patients treated with ergot derivatives such as lisuride cases of pericarditis (inflammation of the outer lining of the heart) and pericardial effusion (accumulation of fluid between the outer lining of the heart and the heart itself) have been reported very rarely (affecting less than one person in
„Pri bolnikih, zdravljenimi z derivati ergota npr. lizurid, so zelo redko poročali o primerih perikarditisa (vnetje osrčnika) in perikardialnem izlivu (nabiranje tekočine med osrčnikom in srcem) (prizadene manj kot eno od 10.000 oseb).
In a few patients on bromocriptine, particularly on long-term and high-dose treatment, retroperitoneal fibrosis has been reported.
Pri nekaj bolnikih, zdravljenih z bromokriptinom, posebno pri tistih na dolgotrajnem zdravljenju z visokimi odmerki, so poročali o retroperitonealni fibrozi.
The following should be included under cardiac disorders: “Very rare: cardiac valvulopathy (including regurgitation) and related disorders (pericarditis and pericardial effusion).”
Vključiti je treba naslednje pod Bolezni srca: “Zelo redki: srčna valvulopatija (vključno z regurgitacijo) in z njo povezane bolezni (perikarditis in perikardialni izliv).”
Also, effects on the heart valve have been observed in patients treated with ergot derivatives.
Pri bolnikih, zdravljenimi z derivati ergota, so opazili tudi učinke na srčne zaklopke.
“Among patients on dihydroergocryptine, particularly on long-term and high-dose treatment, pleural and pericardial effusions, as well as pleural and pulmonary fibrosis and constrictive pericarditis have occasionally been reported.
“Med bolniki, ki dobivajo dihidroergokriptin, še zlasti pri dolgotrajnem zdravljenju ali zdravljenju z visokimi odmerki, so občasno poročali o plevralnih in perikardialnih izlivih, pa tudi o plevralni in pljučni fibrozi in konstrikcijskem perikarditisu.
“Very rare side effect (affecting less than one person in 10.000): heart valve and related disorders e.g. inflammation (pericarditis) or leaking of fluid in the pericardium (pericardial effusion).
»Zelo redek neželeni učinek (pri manj kot eni osebi na 10.000): bolezni srčne zaklopke ali z njo povezane motnje, npr. vnetje (perikarditis) ali prehajanje tekočine v perikardialni prostor (perikardialni izliv).
“Among patients on bromocriptine, particularly on long-term and high-dose treatment, pleural and pericardial effusions, as well as pleural and pulmonary fibrosis and constrictive pericarditis have occasionally been reported.
»Pri bolnikih, ki se zdravijo z bromokriptinom, posebno pri tistih na dolgotrajnem zdravljenju z visokimi odmerki, so občasno poročali o plevralnih in perikardialnih izlivih, kakor tudi o plevralni in pljučni fibrozi in konstrikcijskem perikarditisu.
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR DIHYDROERGOCRYPTINE CONTAINING MEDICINAL PRODUCTS
SPREMEMBE, KI JIH JE POTREBNO VKLJUČITI V USTREZNA POGLAVJA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA ZA VSA ZDRAVILA, KI VSEBUJEJO DIHIDROERGOKRIPTIN
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR BROMOCRIPTINE CONTAINING MEDICINAL PRODUCTS
SPREMEMBE, KI JIH JE POTREBNO VKLJUČITI V USTREZNA POGLAVJA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA ZA VSA ZDRAVILA, KI VSEBUJEJO BROMOKRIPTIN
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR LISURIDE CONTAINING MEDICINAL PRODUCTS
SPREMEMBE, KI JIH JE POTREBNO VKLJUČITI V USTREZNA POGLAVJA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA ZA VSA ZDRAVILA, KI VSEBUJEJO LIZURID
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET FOR DIHYDROERGOCRYPTINE CONTAINING MEDICINAL PRODUCTS
POPRAVKI, KI JIH JE POTREBNO VKLJUČITI V USTREZNA POGLAVJA NAVODILA ZA UPORABO PRI VSEH ZDRAVILIH, KI VSEBUJEJO DIHIDROERGOKRIPTIN
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET FOR BROMOCRIPTINE CONTAINING MEDICINAL PRODUCTS
POPRAVKI, KI JIH JE POTREBNO VKLJUČITI V USTREZNA POGLAVJA NAVODILA ZA UPORABO PRI VSEH ZDRAVILIH, KI VSEBUJEJO BROMOKRIPTIN
European Commission issued a decision on 7 October 2011.
Evropska komisija je izdala odločbo dne 7. oktobra 2011.
7 October 2011
7. oktober 2011
The company that markets these medicines is Pfizer.
Družba, ki trži ta zdravila, je Pfizer.
Why was Norvasc reviewed?
Zakaj je bilo zdravilo Norvasc pregledano?
Norvasc is authorised in the EU via national procedures.
Zdravilo Norvasc je v EU odobreno z nacionalnimi postopki.
It blocks special channels on the surface of cells called calcium channels, through which calcium particles normally enter.
Zavira posebne kanalčke na površini celic, imenovane kalcijevi kanalčki, skozi katere običajno prehajajo kalcijevi delci.
The European Medicines Agency has completed a review of Norvasc.
Evropska agencija za zdravila je zaključila pregled zdravila Norvasc.
Dosing instructions were already harmonised in all EU countries, however, not all countries had dosing recommendations for Norvasc when used together with other medicines.
Navodila za odmerjanje so bila v EU že usklajena, vendar v vseh državah ni bilo priporočil za odmerjanje, če se zdravilo Norvasc uporablja skupaj z drugimi zdravili.
Norvasc is medicine that contains the active substance amlodipine.
Norvasc je zdravilo, ki vsebuje zdravilno učinkovino amlodipin.
Norvasc is also available in the EU under other trade names: Amlodipine Pfizer, Amlodipino, Amlor, Istin, Monopina, and Norvasc.
Zdravilo Norvasc je v EU na voljo tudi pod drugimi imeni: Amlodipine Pfizer, Amlodipino, Amlor, Istin, Monopina in Norvasc.
What is Norvasc?
Kaj je zdravilo Norvasc?
The CHMP also harmonised other sections of the SmPC including sections 4.5 (interaction with other medicinal products and other forms of interaction) and 5.1 (pharmacodynamic properties)
CHMP je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavjema 4.5 (Medsebojno delovanje z drugimi zdravili in druge oblike interakcij) in 5.1 (Farmakodinamične lastnosti).
Norvasc had been used to treat hypertension and angina in all EU countries.
Zdravilo Norvasc se je uporabljalo za zdravljenje hipertenzije in angine pektoris v vseh državah EU.
On 2 February 2011, Pfizer referred the matter to the CHMP in order to harmonise the SmPCs as well as to standardise the test used for examining the quality of Norvasc in the EU.
Družba Pfizer je dne 2. februarja 2011 zadevo napotila na CHMP, da se uskladi povzetek glavnih značilnosti zdravila ter da se standardizira preiskava za ugotavljanje kakovosti zdravila Norvasc v EU.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Norvasc in the European Union (EU).
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba v Evropski uniji (EU) uskladiti podatke o predpisovanju zdravila Norvasc.
A type of angina called vasospastic or Prinzmetal's angina was approved in all EU countries except Denmark and Sweden, while coronary artery disease was approved in Latvia and Romania.
V vseh državah EU razen na Danskem in Švedskem je bila odobrena indikacija vrsta angine, imenovana Prinzmetalova angina, medtem ko je bila v Latviji in Romuniji odobrena indikacija bolezen koronarnih arterij.
The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
CHMP je ob upoštevanju predloženih podatkov in znanstvenih razprav v okviru odbora menil, da je treba povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo uskladiti v celotni EU.
When calcium enter the cells in the muscles of blood vessel walls, this causes contraction.
Ko kalcij vstopi v celice mišic v žilni steni, se stena skrči.
It has been used to treat cardiovascular problems such as hypertension (high blood pressure) and angina (chest pain caused by problems with the blood flow to the heart).
Uporablja se za zdravljenje težav s srcem in ožiljem, kot sta hipertenzija (visok krvni tlak) in angina (bolečine v prsnem košu zaradi težav s pretokom krvi v srce).
This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
To je v različnih državah članicah, kjer je zdravilo v prometu, privedlo do razhajanj glede uporabe zdravila, kot je razvidno iz razlik v povzetkih glavnih značilnosti zdravila, označevanju in navodilih za uporabo.
The CHMP harmonised the indications, recommending that Norvasc be used for: hypertension, chronic stable angina and vasospastic or Prinzmetal's angina.
CHMP je uskladil indikacije in priporočil uporabo zdravila Norvasc za: hipertenzijo, kronično stabilno angino pektoris in vazospastično ali Prinzmetalovo angino pektoris.
The CHMP harmonised the contraindication as follows: hypersensitivity (allergy) to dihydropyridine derivatives, amlodipine or to any of the excipients; severe hypotension (low blood pressure), shock (a steep fall in blood pressure), obstruction of the outflow tract of the left ventricle (a chamber in the heart) and patients with heart failure following a heart attack.
CHMP je uskladil kontraindikacije, in sicer: preobčutljivost za (alergija na) dihidropiridinske derivate, amlodipin ali katero koli pomožno snov; huda hipotenzija (nizek krvni tlak), šok (velik padec krvnega tlaka), obstrukcija iztoka iz levega srčnega prekata in bolniki s srčnim popuščanjem po srčnem infarktu.
By reducing the flow of calcium into the cells, amlodipine prevents the blood vessel walls from contracting, thus lowering the blood pressure for patients with hypertension and helping to make it easier for patients with heart problems to pump blood around the body.
Amlodipin zmanjša pretok kalcija v celice, zato prepreči krčenje žilnih sten, kar zmanjša krvni tlak pri bolnikih s hipertenzijo in srcu olajša črpanje krvi po telesu pri srčnih bolnikih.
The CHMP has recommended that no dose adjustments for Norvasc are required when used together with the following antihypertensive medicines: thiazide, beta blockers, and angiotensin-converting enzyme (ACE) inhibitors.
CHMP je priporočil, da v primeru uporabe zdravila Norvasc skupaj z naslednjimi antihipertenzivnimi zdravili prilagajanje odmerka ni potrebno: tiazid, zaviralci beta, zaviralci angiotenzinske konvertaze (ACE).
Date of first authorisation: 10 March 2004 Date of latest renewal: 10 March 2009
Datum prve odobritve: 10. marec 2004 Datum zadnjega podaljšanja: 10. marec 2009
There were no new safety concerns arising from this small study, but 5-year data are yet not available.
Ta majhna študija ni sprožila novih pomislekov glede varnosti, vendar 5-letni podatki še niso na voljo.
NOTE: Activate away from self and others.
OPOMBA: Aktivirajte ga proč od sebe in drugih.
Supportive PFS analyses were based on an Independent Central Radiology Review.
Podporne analize PFS so temeljile na neodvisnem centralnem radiološkem pregledu.
Currently available data are described in sections 5.1 and 5.2, but no recommendation on a posology can be made.
Trenutno razpoložljivi podatki so opisani v poglavjih 5.1 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
Adult females (including Elderly)
Odrasle ženske (vključno s starejšimi)
Number of patients at risk
Število bolnikov izpostavljenih tveganju
The event was not observed in major clinical studies (CONFIRM, FINDER 1, FINDER 2, NEWEST).
Dogodek ni bil opažen v velikih kliničnih študijah (CONFIRM, FINDER 1, FINDER 2, NEWEST).
Patients with a best objective response of complete response, partial response or stable disease ≥24 weeks.
Bolniki z najboljšim objektivnim odzivom celotnega odziva, delni odziv ali stabilna bolezen ≥ 24 tednov.
Type of estimate; treatment comparison
Spremenljivka vrsta ocene; primerjava zdravljenja
• Remove the cap (A) in a straight upward direction.
• Odstranite pokrovček (A) v smeri naravnost navzgor.
The acute toxicity of fulvestrant is low.
Akutna toksičnost fulvestranta je nizka.
Median DoR (months) CBR
Mediano DoR (meseci) CBR
This medicine may pose a risk to the aquatic environment.
To zdravilo lahko pomeni tveganje za vodno okolje.
However, if you feel tired after treatment do not drive or use machines.
Če boste po zdravljenju občutili utrujenost, ne vozite ali upravljajte strojev.
Time (Month)
Čas (meseci)
The frequency has been calculated using the upper limit of the 95% confidence interval for the point estimate.
Pogostost je bila izračunana z uporabo zgornje meje 95 % intervala zaupanja točkovne ocene.
Fulvestrant showed no genotoxic potential.
Fulvestrant ne kaže genotoksičnega potenciala.
Fulvestrant is highly (99%) bound to plasma proteins.
Fulvestrant se v velikem obsegu (99 %) veže na plazemske proteine.
Clinical efficacy and safety in advanced breast cancer
Klinična učinkovitost in varnost pri napredovalem raku dojke
Store and transport in a refrigerator.
Shranjujte in prevažajte v hladilniku.
*Response results based on confirmed and unconfirmed responses.
*Rezultati odziva na podlagi potrjenih in nepotrjenih odzivov.
In particular, you should tell your doctor if you are using anticoagulants (medicines to prevent blood clots).
Povejte zdravniku, če uporabljate antikoagulante (zdravila, ki preprečujejo nastanek krvnih strdkov).
If overdose occurs, symptomatic supportive treatment is recommended.
V primeru prevelikega odmerjanja je priporočljivo simptomatsko podporno zdravljenje.
You may need immediate medical treatment if you experience any of the following side effects:
Morda boste potrebovali takojšnje zdravljenje, če se pri vas pojavi kateri od naslednjih neželenih učinkov:
Effects on bone
Učinki na kosti
There were no statistically significant differences in any of these endpoints between the two treatment groups.
Med obema zdravljenima skupinama ni bilo statistično značilnih razlik v nobenem od omenjenih končnih ciljev.
ALT=alanine aminotransferase; AST=aspartate aminotransferase; N/n=number of patients Preferred Terms (PTs) are listed according to MedDRA 17.1.
ALT = alanin-aminotransferaza, AST = aspartat-aminotransferaza, N/n = število bolnikov Priporočeni izrazi (PTs - Preferred Terms) so navedeni v skladu z MedDRA 17.1.
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 so se pojavili pri višjih koncentracijah izpostavljenosti, kot so bile pri bolnicah (Cmax > 15-krat), in imajo verjetno omejen pomen za varnost pri ljudeh ob kliničnih odmerkih.
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'.
Ta je izračunana kot 3/560 (kjer je 560 število bolnikov v velikih kliničnih študijah), kar ustreza kategoriji pogostosti 'občasni'.
Children and adolescents Faslodex is not indicated in children and adolescents under 18 years.
Otroci in mladostniki Zdravilo Faslodex ni indicirano pri otrocih in mladostnikih mlajših od 18 let.
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).
Zdravila Faslodex ni priporočljivo uporabljati pri otrocih in mladostnikih, ker varnost in učinkovitost nista bili ugotovljeni pri tej skupini bolnikov (glejte poglavje 5.1).
% of patients with CB; absolute difference in
% bolnikov z CB; absolutna razlika v %
This section provides information based on all adverse reactions from clinical studies, post-marketing studies or spontaneous reports.
To poglavje navaja informacije, ki temeljijo na vseh neželenih učinkih iz kliničnih študij, študij v obdobju trženja in spontanih poročil.
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 primerih povezani z rastjo raka dojke.
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 %.
OS is presented for the final survival analyses at 75% maturity.
Celotno preživetje je predstavljeno za končne analize preživetja ob 75 % zrelosti.
A more mature update of efficacy data is reported in Table 5.
Bolj zrela posodobitev podatkov o učinkovitosti je prikazana v preglednici 5.
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).
Pogostnosti so opredeljene glede na sledeči dogovor: zelo pogosti ( 1/10), pogosti ( 1/100 do < 1/10), občasni ( 1/1000 do < 1/100).
Temperature excursions outside 2°C - 8°C should be limited.
Temperaturni odkloni zunaj razpona od 2 °C do 8 °C morajo biti omejeni.
Due to the mechanism of action of fulvestrant, there is a potential risk of osteoporosis.
Glede na mehanizem delovanja fulvestranta obstaja tveganje za razvoj osteoporoze.
TTR*, Median [months (range)]
TTR*, mediana [meseci (razpon)]
Infections includes all PTs that are part of the System Organ Class Infections and infestations.
Okužbe vključujejo vse PTs, ki so del organskega sistema Infekcijske in parazitske bolezni.
FUL=fulvestrant; PAL=palbociclib; PCB=placebo.
FUL = fulvestrant; PAL = palbociklib; PCB = placebo
The role of sex hormone-binding globulin (SHBG) has not been determined.
Vloga globulina, ki veže spolne hormone (SHBG), ni bila ugotovljena.
Fulvestrant is subject to extensive and rapid distribution.
Fulvestrant se obsežno in hitro porazdeli.
• Thromboembolism (increased risk of blood clots)*
• tromboembolizem (povečano tveganje za nastanek krvnih strdkov)*
Do not use Faslodex: - if you are allergic to fulvestrant or to any of the other ingredients of this medicine (listed in section 6) - if you are pregnant or breast-feeding - if you have severe liver problems
Ne uporabljajte zdravila Faslodex - če ste alergični na fulvestrant ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če ste noseči ali dojite; - če imate resne težave z jetri.
A total of 17.1% of patients received a prior chemotherapy regimen for advanced disease; 84.2% of patients had measurable disease.
Skupno 17,1 % bolnic je predhodno prejemalo kemoterapijo za zdravljenje napredovale bolezni; 84,2 % bolnic je imelo merljivo bolezen.
Hands must remain behind the needle at all times during use and disposal.
Roke morajo ves čas - med uporabo in odlaganjem - ostati za iglo.
, hepatitis f, elevated gamma-GT
, hepatitis f, zvišanje gama-GT
Warning - Do not autoclave safety needle (BD SafetyGlide Shielding Hypodermic Needle) before use.
Opozorilo - Varnostne igle (BD SafetyGlide Shielding Hypodermic Needle) pred uporabo ne avtoklavirajte.
Fulvestrant is eliminated mainly in metabolised form.
Fulvestrant se izloča predvsem v presnovljeni obliki.
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.
The efficacy results of the FALCON study are presented in Table 4 and Figure 1.
Rezultati učinkovitosti iz študije FALCON so prikazani v preglednici 4 in na sliki 1.
Febrile neutropenia has been reported in 0.9% patients receiving fulvestrant in combination with palbociclib.
O febrilni nevtropeniji so poročali pri 0,9 % bolnic, ki so prejemale fulvestrant v kombinaciji s palbociklibom.
Your healthcare professional will be responsible for the correct storage, use and disposal of Faslodex.
Zdravnik bo odgovoren za pravilno shranjevanje, uporabo in odstranjevanje zdravila Faslodex.
System Organ Class Frequency Preferred Term
Organski sistem Pogostnost Priporočeni izraz
Effects on the postmenopausal endometrium
Učinki na endometrij po menopavzi
If you have any questions about palbociclib, please ask your doctor.
Če imate kakšna vprašanja o palbociklibu, vprašajte zdravnika.
The median time to death was 27.4 months for patients treated with Faslodex 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.
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 vrednost brez korekcije za večkratne primerjave med uvodnimi analizami celokupnega preživetja ob 50 % zrelosti in posodobljenimi analizami preživetja pri 75 % zrelosti.
Approximately 20% of patients were pre/perimenopausal.
Približno 20 % bolnic je bilo pred menopavzo/v perimenopavzi.
The frequencies in Table 1 were based on all reported adverse drug reactions, regardless of the investigator assessment of causality.
Pogostnosti v preglednici 1 temeljijo na vseh prijavljenih neželenih učinkih, ne glede na raziskovalčevo oceno njihove vzročnosti.
No interaction studies were conducted on competitive protein binding.
Študije medsebojnega delovanja z zdravili v zvezi s kompetitivno vezavo na proteine niso bile izvedene.
• 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)
• nenadna šibkost, omrtvičenost, mravljinčenje ali poslabšanje gibanja noge, zlasti če se pojavi le na eni strani telesa, nenadne težave s hojo ali ravnotežjem (periferna nevropatija)
• Abnormal levels of liver enzymes (in blood tests)*
• nenormalni izvidi jetrnih encimov (na preiskavah krvi)*
• Weakness, tiredness*
• šibkost, utrujenost*
Very low density lipoprotein (VLDL), low 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.
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.
No data are available regarding endometrial morphology.
Na voljo ni podatkov o morfologiji endometrija.
After temperature excursions, the product should be returned immediately to the recommended storage conditions (store and transport in a refrigerator 2°C - 8°C).
Po temperaturnih odklonih je treba zdravilo takoj vrniti v priporočene pogoje shranjevanja (shranjujte in prevažajte v hladilniku, 2 °C - 8 °C).
Additional efficacy measures (OR and TTR) assessed in the sub-groups of patients with or without visceral disease are displayed in Table 6.
Dodatni meri učinkovitosti (OR in TTR), ocenjeni v podskupinah bolnic z visceralno boleznijo ali brez nje, sta prikazani v preglednici 6.
After intramuscular administration, the exposure is approximately dose-proportional in the dose range 50 to 500 mg.
Po intramuskularni aplikaciji je izpostavljenost približno sorazmerna z odmerkom v območju odmerkov od 50 do 500 mg.
• Attach the safety needle to the Luer-Lok and twist until firmly seated (see Figure 3).
• Namestite varnostno iglo na Luer-Lok in jo zasučite, dokler trdno ne sede (glejte sliko 3).
You must not use Faslodex if you are pregnant.
Zdravila Faslodex ne smete jemati, če ste noseči.
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 fulvestranta še ni popolnoma poznana, vendar pa vključuje kombinacije številnih možnih poti biotransformacije, analognih tistim za endogene steroide.
The median duration of fulvestrant 500 mg treatment across the pooled dataset (including the studies mentioned above plus FALCON) was 6.5 months.
Mediano trajanje zdravljenja s 500 mg fulvestranta je bilo v kumulativnem naboru podatkov (vključno z zgoraj omenjenimi študijami in študijo FALCON) 6,5 meseca.