natgillin/translations-raw huggingface dataset:
The application was a joint application from Marvel LifeSciences for Isomarv medium and two other medicines (Solumarv and Combimarv, also developed as biosimilar medicines).
Vloga, ki jo je predložila družba Marvel LifeSciences, je bila skupna vloga za zdravilo Isomarv medium in dve drugi zdravili (Solumarv in Combimarv, ki sta bili prav tako razviti kot podobni biološki zdravili).
Isomarv medium is a medicine that contains the active substance human insulin.
Isomarv medium je zdravilo, ki vsebuje zdravilno učinkovino humani insulin.
Isomarv medium was expected to be used to treat patients with diabetes who require insulin to control their blood glucose (sugar).
Zdravilo Isomarv medium naj bi se uporabljalo za zdravljenje bolnikov s sladkorno boleznijo, ki potrebujejo insulin za uravnavanje glukoze (sladkorja) v krvi.
Isomarv medium was developed as a biosimilar medicine.
Zdravilo Isomarv medium je bilo razvito kot biološko podobno zdravilo.
Isomarv medium was intended as a replacement insulin that is similar to the insulin made by the body.
Zdravilo Isomarv medium naj bi bilo nadomestni insulin, ki je podoben insulinu, ki nastaja v telesu.
What is Isomarv medium?
Kaj je zdravilo Isomarv medium?
What was Isomarv medium expected to be used for?
Za kaj naj bi se zdravilo Isomarv medium uporabljalo?
Among these were results from studies that looked at how the body handles Isomarv medium compared with Humulin I and how these insulins affect blood sugar levels.
Družba je predložila rezultate študij, ki naj bi dokazale, da je zdravilo Isomarv medium po svoji sestavi, biološki aktivnosti in klinični učinkovitosti podobno referenčnemu zdravilu Humulin I. Med rezultati so bili tudi rezultati študij, v katerih so proučevali, kako se telo odziva na zdravilo Isomarv medium v primerjavi z zdravilom Humulin I, in kako omenjena insulina vplivata na ravni krvnega sladkorja.
How is Isomarv medium expected to work?
Kako naj bi zdravilo Isomarv medium delovalo?
The reference medicine for Isomarv medium in this application was Humulin I. For more information on biosimilar medicines, see the questions-and-answers document here.
Referenčno zdravilo za zdravilo Isomarv medium v tej vlogi je bilo zdravilo Humulin I.
Co. Galway IRELAND
Co. Galway IRSKA
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08 january 2018
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 08 januar 2018
7.4 (3.9, NE)
7,4 (3,9; NO)
Adult females (including elderly)
Odrasle ženske (vključno s starejšimi osebami)
The event was not observed in major clinical studies (CONFIRM, FINDER 1, FINDER 2, NEWEST).
c 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.
e Bolnice z najboljšim objektivnim odzivom celotnega odziva, delni odziv ali stabilna bolezen ≥ 24 tednov.
Children and adolescents Fulvestrant Mylan is not indicated in children and adolescents under 18 years.
Otroci in mladostniki Zdravilo Fulvestrant Mylan ni indicirano pri otrocih in mladostnikih, mlajših od 18 let.
% of patients with CB; absolute difference in
% bolnic s CB; absolutna razlika v %
However, if you feel tired after treatment do not drive or use machines.
Če boste po zdravljenju občutili utrujenost, ne vozite ali upravljajte s stroji.
Fulvestrant 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).
Fulvestranta ni priporočljivo uporabljati pri otrocih in mladostnikih, ker varnost in učinkovitost nista bili ugotovljeni pri tej skupini bolnikov (glejte poglavje 5.1).
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 po prihodu zdravila na trg ali spontanih poročil.
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).
Your healthcare professional will be responsible for the correct storage, use and disposal of Fulvestrant Mylan.
Zdravstveni delavec bo odgovoren za pravilno shranjevanje, uporabo in odstranjevanje zdravila Fulvestrant Mylan.
Pharmacotherapeutic group: Endocrine therapy, anti-estrogens, ATC code: L02BA03
Farmakoterapevtska skupina: Endokrino zdravljenje, antiestrogeni, oznaka ATC: L02BA03
The median time to death was 27.4 months 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.
Fulvestrant is not indicated for use in children.
Fulvestrant ni indiciran za uporabo pri otrocih.
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.
FUL=fulvestrant; PAL=palbociclib; PCB=placebo.
FUL=fulvestrant; PAL=palbociklib; PCB=placebo
Do not use Fulvestrant Mylan: - 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 Fulvestrant Mylan: - 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.
Fulvestrant is contraindicated in pregnancy (see section 4.3).
Fulvestrant je kontraindiciran v nosečnosti (glejte poglavje 4.3).
To maintain sterility do not touch the syringe tip (B) (see Figure 2).
Zaradi ohranitve sterilnosti se ne dotikajte konice brizge (B) (glejte sliko 2).
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.
• Abnormal levels of liver enzymes (in blood tests)*
• nenormalni izvidi jetrnih encimov (pri preiskavah krvi)*
Fulvestrant has no or negligible influence on the ability to drive or use machines.
Fulvestrant nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
You must not use Fulvestrant Mylan if you are pregnant.
Zdravila Fulvestrant Mylan ne smete jemati, če ste noseči.
Overall, fulvestrant at the 250 mg monthly dose was at least as effective as anastrozole in terms of progression free survival, objective response, and time to death.
V celoti je bil fulvestrant v mesečnem odmerku 250 mg vsaj tako učinkovit kot anastrozol v smislu preživetja brez napredovanja bolezni, objektivnega odgovora in časa do nastopa smrti.
ALT=alanine aminotransferase; AST=aspartate aminotransferase; N/n=number of patients a Preferred Terms (PTs) are listed according to MedDRA 17.1. b Infections includes all PTs that are part of the System Organ Class Infections and infestations.
ALT = alanin-aminotransferaza, AST = aspartat-aminotransferaza, N/n = število bolnikov a Priporočeni izrazi (PTs - Preferred Terms) so navedeni v skladu z MedDRA 17.1. b Okužbe vključujejo vse PTs, ki so del organskega sistema Infekcijske in parazitske bolezni.
Combined analysis of both studies showed that 83% of patients who received fulvestrant progressed, compared with 85% of patients who received anastrozole.
Kombinirane analize obeh študij so pokazale, da je do napredovanja bolezni prišlo pri 83 % bolnic, ki so prejemale fulvestrant, v primerjavi s 85 % bolnic, ki so prejemale anastrozol.
In toxicity studies with multiple intramuscular doses of fulvestrant in rats and dogs, the antiestrogenic activity of fulvestrant was responsible for most of the effects seen, particularly in the female reproductive system, but also in other organs sensitive to hormones in both sexes.
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.
Fertility The effects of fulvestrant on fertility in humans has not been studied.
Plodnost Vpliv fulvestranta na plodnost pri človeku ni raziskan.
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.
c Nominalna p-vrednost brez korekcije za večkratne primerjave med uvodnimi analizami celokupnega preživetja ob 50-% zrelosti in posodobljenimi analizami preživetja pri 75-% zrelosti.
However, as fulvestrant exposure may be increased, fulvestrant should be used with caution in these patients.
Vendar se izpostavljenost fulvestrantu lahko poveča, zato je fulvestrant pri teh bolnicah potrebno uporabljati s previdnostjo.
The European Medicines Agency has waived the obligation to submit the results of studies with fulvestrant in all subsets of the paediatric population in breast cancer (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom fulvestrant za vse podskupine pediatrične populacije pri raku dojke (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
After administration of fulvestrant long-acting intramuscular injection, fulvestrant is slowly absorbed and maximum plasma concentrations (Cmax) are reached after about 5 days.
Po aplikaciji dolgodelujoče intramuskularne injekcije fulvestranta se fulvestrant počasi absorbira in doseže največje plazemske koncentracije (Cmax) po okoli 5 dneh.
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1253/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/17/1253/001
• After injection, immediately apply a single-finger stroke to the activation assisted lever arm to activate the shielding mechanism (see Figure 5).
• Takoj po injiciranju z enim prstom sprožite ročico za pomoč pri aktiviranju, da aktivirate mehanizem za zaščito (glejte sliko 5).
If you can become pregnant, you should use effective contraception while being treated with Fulvestrant Mylan.
Če bi lahko zanosili, morate med zdravljenjem z zdravilom Fulvestrant Mylan uporabljati učinkovito kontracepcijo.
The safety and efficacy of fulvestrant in children from birth to 18 years of age have not been established.
Varnost in učinkovitost fulvestranta pri otrocih od rojstva do18.
• Attach the safety needle to the Luer-Lok and twist until firmly seated (see Figure 3).
• Namestite varnostno iglo na Luer-Lok in jo sukajte, dokler ni trdno nameščena (glejte sliko 3).
OR [% (95% CI)] TTR*, Median [months (range)]
OR [% (95 % IZ)] TTR*, mediana [meseci (razpon)]
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.
• Bruising and bleeding at the site of injection
• modrice in krvavitev na mestu injiciranja
* Includes side effects for which the exact role of Fulvestrant Mylan cannot be assessed due to the underlying disease.
*Vključuje neželene učinke, pri katerih zaradi osnovne bolezni ni mogoče natančno oceniti vloge zdravila Fulvestrant Mylan.
The efficacy and safety of fulvestrant (either as monotherapy or in combination with palbociclib) have not been studied in patients with critical visceral disease.
Učinkovitost in varnost fulvestranta (kot samostojno zdravljenje ali v kombinaciji s palbociklibom) nista raziskani pri bolnicah s kritično visceralno boleznijo.
Therefore these findings are not considered to be relevant to the use of fulvestrant in postmenopausal women with advanced breast cancer.
Zato se ta odkritja ne smatrajo kot klinično pomembna pri uporabi fulvestranta pri ženskah v pomenopavzi z napredovalim rakom dojke.
OS is presented for the final survival analyses at 75 % maturity.
b Celokupno preživetje je predstavljeno za končne analize preživetja ob 75-% zrelosti.
In a population pharmacokinetic analysis of data from phase 3 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.
V populacijskih farmakokinetičnih analizah podatkov iz študij 3. faze niso ugotovili nobenih razlik v farmakokinetičnih profilih fulvestranta glede na starost (območje od 33 do 89 let), maso (40-127 kg) ali raso.
Safety and efficacy have not been evaluated in patients with severe renal impairment (creatinine clearance <30 ml/min), and, therefore, caution is recommended in these patients (see section 4.4).
Varnost in učinkovitost zdravila pri bolnicah s hudo ledvično okvaro (kreatininski očistek < 30 ml/min) nista bili ugotovljeni in zato je pri teh bolnicah potrebna previdnost (glejte poglavje 4.4).
The objective response rate for Fulvestrant 250 mg was 19.2% compared with 16.5% for anastrozole.
Objektivni delež odgovorov je bil za fulvestrant 250 mg 19,2 % v primerjavi s 16,5 % pri anastrozolu.
Induction of such tumours is consistent with pharmacology-related endocrine feedback alterations in gonadotropin levels caused by anti-estrogens in cycling animals.
Indukcija tovrstnih tumorjev je v skladu s farmakološko povezanimi spremembami endokrine povratne zanke pri ravneh gonadotropina, ki jih povzročajo antiestrogeni pri živalih, ki imajo cikluse.
The mechanism of action is associated with down-regulation of estrogen receptor protein levels.
Mehanizem delovanja je povezan z zmanjšanjem ravni estrogenskega receptorskega (ER) proteina.
Women with severe hepatic impairment (Child-Pugh class C) were not evaluated.
Ženske s hudo jetrno okvaro (stopnjo C po Child-Pughovi klasifikaciji) niso bile ovrednotene.
A reduction in the risk of disease progression or death in the fulvestrant plus palbociclib arm was observed in all individual patient subgroups defined by stratification factors and baseline characteristics.
Zmanjšanje tveganja za napredovanje bolezni ali smrt so v skupini s kombinacijo fulvestranta in palbocikliba opažali v vseh podskupinah bolnic, opredeljenih po stratifikacijskih faktorjih in izhodiščnih značilnostih.
Updated Analysis (23 October 2015 cut-off) Fulvestrant plus palbociclib (N=347)
Posodobljena analiza (datum zamejitve 23. oktober 2015) fulvestrant in palbociklib (N = 347)
Of the 65 patients in the fulvestrant arm, 40% (26/65) of patients reported joint and musculoskeletal pain within the first month of treatment, and 66.2% (43/65) of patients within the first 3 months of treatment.
Od 65 bolnic v skupini s fulvestrantom jih je 40 % (26/65) poročalo o sklepnih in mišično-skeletnih bolečinah v prvem mesecu zdravljenja in 66,2 % (43/65) v prvih 3 mesecih zdravljenja.
PFS:Progression-free survival; ORR:Objective response rate; OR:Objective response; CBR:Clinical benefit rate; CB:Clinical benefit; OS:Overall survival; K-M:Kaplan-Meier; CI:Confidence interval; AI:Aromatase inhibitor; AE:Anti-estrogen.
PFS: preživetje brez napredovanja bolezni; ORR: objektivni delež odziva; OR: objektivni odziv; CBR: delež klinične dobrobiti; CB: klinična korist; OS: celokupno preživetje; K-M: Kaplan-Meier; IZ: interval zaupanja; AI: zaviralec aromataze; AE: antiestrogen.
Manufacturer MYLAN TEORANTA Inverin
Izdelovalec MYLAN TEORANTA Inverin
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 pri temperaturi 2-8 °C).
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.
Seventy seven percent (77%) of the study population had estrogen receptor positive breast cancer.
V skupini bolnic, ki so sodelovale v študiji, jih je sedeminsedemdeset odstotkov (77 %) imelo rak dojke s pozitivnimi estrogenskimi receptorji.
This study compared the efficacy and safety of fulvestrant 500 mg (n=362) with fulvestrant 250 mg (n=374).
Ta študija je primerjala učinkovitost in varnost fulvestranta 500 mg (n = 362) in fulvestranta 250 mg (n = 374).
In table 1, the following frequency categories for adverse drug reactions (ADRs) were calculated based on the fulvestrant 500 mg treatment group in pooled safety analyses of studies that compared fulvestrant 500 mg with fulvestrant 250 mg [CONFIRM (Study D6997C00002), FINDER 1 (Study D6997C00004), FINDER 2 (Study D6997C00006), and NEWEST (Study D6997C00003) studies], or from FALCON (Study D699BC00001) alone that compared fulvestrant 500 mg with anastrozole 1 mg. Where frequencies differ between the pooled safety analysis and FALCON, the highest frequency is presented.
V preglednici 1 so naslednje kategorije pogostnosti neželenih učinkov zdravila izračunane na podlagi skupine, zdravljene s fulvestrantom 500 mg v kumulativnih analizah varnosti študij, ki so primerjale fulvestrant 500 mg s fulvestrantom 250 mg [CONFIRM (študija D6997C00002), FINDER 1 (študija D6997C00004), FINDER 2 (študija D6997C00006) in NEWEST (študija D6997C00003)] ali iz same študije FALCON (študija D699BC00001), ki je primerjala fulvestrant 500 mg z 1 mg anastrozola.
Temperature excursions outside 2°C - 8°C should be limited and not exceeding a 28 day period where the average storage temperature for the product is below 25°C (but above 2°C - 8°C).
Temperaturni odkloni zunaj razpona od 2 do 8 °C morajo biti omejeni, obdobje shranjevanja, med katerim je povprečna temperatura za izdelek pod 25 °C (vendar nad 2-8 °C), pa ne sme biti daljše od 28 dni.
Animal studies suggest that no effects other than those related directly or indirectly to anti-estrogenic activity were evident with higher doses of fulvestrant (see section 5.3).
Študije na živalih kažejo, da drugih učinkov kot tistih, ki so neposredno ali posredno povezani z antiestrogenim delovanjem, pri višjih odmerkih fulvestranta niso opazili (glejte poglavje 5.3).
ORR was assessed in patients who were evaluable for response at baseline (i.e. those with measurable disease at baseline: 240 patients in the fulvestrant 500 mg group and 261 patients in the fulvestrant 250 mg group).
d ORR je bila ocenjena pri bolnicah, katerih odgovor je bil ovrednoten na izhodišču (tj. tisti z merljivo boleznijo na začetku raziskave: 240 bolnic v skupini fulvestranta 500 mg in 261 bolnic v skupini fulvestranta
Fulvestrant should be used with caution in patients with severe renal impairment (creatinine clearance less than 30 ml/min).
Fulvestrant uporabljajte previdno pri bolnicah s hudo ledvično okvaro (kreatininski očistek manjši od 30 ml/min).
If pregnancy occurs while taking fulvestrant, the patient must be informed of the potential hazard to the foetus and potential risk for loss of pregnancy.
Če med jemanjem fulvestranta bolnica zanosi, jo je treba seznaniti z možno nevarnostjo za plod in možnim tveganjem za prekinitev nosečnosti.
ADR was not observed in FALCON.
f Neželeni učinek ni bil opažen v študiji FALCON.
117 Allée des Parcs 69800 Saint-Priest FRANCE
117 Allée des Parcs 69800 SAINT-PRIEST FRANCIJA
Keep the pre-filled syringe in the original package in order to protect from light.
Napolnjeno injekcijsko brizgo shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
Includes: arthralgia, and less frequently musculoskeletal pain, myalgia and pain in extremity.
d Vključuje: artralgijo in, manj pogosto, mišično-skeletne bolečine, mialgijo in bolečine v okončini.
Although the data collected were limited, the steady-state trough concentrations of fulvestrant in children appear to be consistent with those in adults.
Čeprav so bili zbrani podatki omejeni, kaže, da so so najnižje koncentracije fulvestranta v stanju dinamičnega ravnovesja pri otrocih podobne koncentracijam pri odraslih.
There are isolated reports of overdose with fulvestrant in humans.
Obstajajo posamezna poročila o primerih prevelikega odmerjanja fulvestranta pri človeku.
The hazard ratio of fulvestrant 250 mg to anastrozole for time to death was 1.01 (95% CI 0.86 to 1.19).
Razmerje ogroženosti med fulvestrantom 250 mg in anastrozolom glede časa do nastopa smrti je bilo 1,01 (95 % IZ 0,86 do 1,19).
-AI subgroup (n=313)a
- podskupina AI (n = 313)a
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Drugi viri informacij Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu.
Thromboembolic events are commonly observed in women with advanced breast cancer and have been observed in clinical studies with fulvestrant (see section 4.8).
Tromboembolične dogodke so pogosto opažali pri ženskah z napredovalim rakom dojke, opazili pa so jih tudi v kliničnih študijah s fulvestrantom (glejte poglavje 4.8).
DOR (measurable disease) [months (95% CI)]
DOR (merljiva bolezen) [meseci (95 % IZ)]
There was up to about 2.5-fold increase in AUC in women with hepatic impairment compared to healthy subjects.
Pri ženskah z jetrno okvaro se je AUC zvišal za približno 2,5-krat v primerjavi z zdravimi ženskami.
CBR [% (95% CI)]
CBR [% (95 % IZ)]
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Druga zdravila in zdravilo Fulvestrant Mylan Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Frequency category differs between pooled safety dataset and FALCON.
e Kategorija pogostnosti se razlikuje med naborom podatkov za kumulativno analizo varnosti in študijo FALCON.
Administration of fulvestrant 500 mg regimen achieves exposure levels at, or close to, steady state within the first month of dosing (mean [CV]: AUC 475 [33.4%] ng.days/ml, Cmax 25.1 [35.3%] ng/ml, Cmin 16.3 [25.9%] ng/ml, respectively).
Uporaba sheme s fulvestrantom 500 mg doseže raven izpostavljenosti, ki je v ali blizu stanja dinamičnega ravnovesja, v prvem mesecu dajanja (povprečje [KV]: AUC 475 [33,4 %] ng.dan/ml, Cmax 25,1 [35,3 %] ng/ml, Cmin 16,3 [25,9 %] ng/ml).
Due to the intramuscular route of administration, fulvestrant should be used with caution if treating patients with bleeding diatheses, thrombocytopenia or those taking anticoagulant treatment.
Zaradi intramuskularne poti uporabe uporabljajte fulvestrant previdno pri zdravljenju bolnic s hemoragično diatezo, trombocitopenijo ali bolnic, ki se zdravijo z antikoagulanti.
An open-label phase 2 study investigated the safety, efficacy and pharmacokinetics of fulvestrant in 30 girls aged 1 to 8 years with Progressive Precocious Puberty associated with McCune Albright Syndrome (MAS).
V odprti študiji 2. faze so raziskovali varnost, učinkovitost in farmakokinetiko fulvestranta pri 30 deklicah, starih od 1 do 8 let, s progresivno prezgodnjo puberteto, povezano z McCuneAlbrightovim sindromom (MAS).
-AE subgroup (n=423)
- podskupina AE (n = 423)
Store and transport refrigerated (2°C - 8°C).
Shranjujte in prevažajte v hladilniku (2-8 °C).
Dose adjustment is therefore not necessary in patients who are receiving fulvestrant and CYP3A4 inhibitors or inducers concomitantly.
Prilagoditev odmerka tako ni potrebna pri bolnicah, ki sočasno uporabljajo fulvestrant in zaviralce ali induktorje CYP3A4.