Everolimus medac 5 mg Tablett

Nazione: Svezia

Lingua: svedese

Fonte: Läkemedelsverket (Medical Products Agency)

Principio attivo:

everolimus

Commercializzato da:

medac pharma s.r.l

Codice ATC:

L01EG02

INN (Nome Internazionale):

everolimus

Dosaggio:

5 mg

Forma farmaceutica:

Tablett

Composizione:

everolimus 5 mg Aktiv substans; laktos (vattenfri) Hjälpämne; laktosmonohydrat Hjälpämne; butylhydroxitoluen Hjälpämne

Tipo di ricetta:

Receptbelagt

Stato dell'autorizzazione:

Avregistrerad

Data dell'autorizzazione:

2019-03-29

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Everolimus medac 5 mg tablets
Everolimus medac 10 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Everolimus medac 5 mg tablets
Each tablet contains 5 mg everolimus.
Excipient with known effect:
Each tablet contains 149 mg lactose.
Everolimus medac 10 mg tablets
Each tablet contains 10 mg everolimus.
Excipient with known effect:
Each tablet contains 297 mg lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
Everolimus medac 5 mg tablets
White, oblong, flat, bevelled edge tablets, marked with “EV” on
one side and “5” on the other.
Everolimus medac 10 mg tablets
White, oblong, flat, bevelled edge tablets, marked with “EV” on
one side and “10” on the other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Hormone receptor-positive advanced breast cancer _
Everolimus medac is indicated for the treatment of hormone
receptor-positive, HER2/neu negative
advanced
breast
cancer,
in
combination
with
exemestane,
in
postmenopausal
women
without
symptomatic visceral disease after recurrence or progression following
a non-steroidal aromatase
inhibitor.
_Neuroendocrine tumours of pancreatic origin _
Everolimus medac is indicated for the treatment of unresectable or
metastatic, well- or moderately-
differentiated neuroendocrine tumours of pancreatic origin in adults
with progressive disease.
_Neuroendocrine tumours of gastrointestinal or lung origin _
Everolimus medac is indicated for the treatment of unresectable or
metastatic, well-differentiated
(Grade 1 or Grade 2) non-functional neuroendocrine tumours of
gastrointestinal or lung origin in adults
with progressive disease (see sections 4.4 and 5.1).
_Renal cell carcinoma _
Everolimus medac is indicated for the treatment of patients with
advanced renal cell carcinoma, whose
disease has progressed on or after treatment with VEGF-targeted
therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Everolimus medac should be initiated and supe