Afinitor

País: União Europeia

Língua: inglês

Origem: EMA (European Medicines Agency)

Ingredientes ativos:

everolimus

Disponível em:

Novartis Europharm Limited

Código ATC:

L01XE10

DCI (Denominação Comum Internacional):

everolimus

Grupo terapêutico:

Antineoplastic agents

Área terapêutica:

Carcinoma, Renal Cell; Breast Neoplasms; Pancreatic Neoplasms

Indicações terapêuticas:

Hormone-receptor-positive advanced breast cancerAfinitor is indicated for the treatment of hormone-receptor-positive, HER2/neu-negative advanced breast cancer, in combination with exemestane, in post-menopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.Neuroendocrine tumours of pancreatic originAfinitor 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 originAfinitor 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.Renal-cell carcinomaAfinitor is indicated for the treatment of patients with advanced renal-cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.

Resumo do produto:

Revision: 30

Status de autorização:

Authorised

Data de autorização:

2009-08-02

Folheto informativo - Bula

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Afinitor 2.5 mg tablets
Afinitor 5 mg tablets
Afinitor 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Afinitor 2.5 mg tablets
Each tablet contains 2.5 mg everolimus.
_Excipient with known effect _
Each tablet contains 74 mg lactose.
Afinitor 5 mg tablets
Each tablet contains 5 mg everolimus.
_Excipient with known effect _
Each tablet contains 149 mg lactose.
Afinitor 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.
Afinitor 2.5 mg tablets
White to slightly yellow, elongated tablets of approximately 10.1 mm
in length and 4.1 mm in width,
with a bevelled edge and no score, engraved with “LCL” on one side
and “NVR” on the other.
Afinitor 5 mg tablets
White to slightly yellow, elongated tablets of approximately 12.1 mm
in length and 4.9 mm in width,
with a bevelled edge and no score, engraved with “5” on one side
and “NVR” on the other.
Afinitor 10 mg tablets
White to slightly yellow, elongated tablets of approximately 15.1 mm
in length and 6.0 mm in width,
with a bevelled edge and no score, engraved with “UHE” on one side
and “NVR” on the other.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hormone receptor-positive advanced breast cancer
Afinitor 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
Afinitor 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
Afinitor is indicated for the treatment of unr

Características técnicas

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Afinitor 2.5 mg tablets
Afinitor 5 mg tablets
Afinitor 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Afinitor 2.5 mg tablets
Each tablet contains 2.5 mg everolimus.
_Excipient with known effect _
Each tablet contains 74 mg lactose.
Afinitor 5 mg tablets
Each tablet contains 5 mg everolimus.
_Excipient with known effect _
Each tablet contains 149 mg lactose.
Afinitor 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.
Afinitor 2.5 mg tablets
White to slightly yellow, elongated tablets of approximately 10.1 mm
in length and 4.1 mm in width,
with a bevelled edge and no score, engraved with “LCL” on one side
and “NVR” on the other.
Afinitor 5 mg tablets
White to slightly yellow, elongated tablets of approximately 12.1 mm
in length and 4.9 mm in width,
with a bevelled edge and no score, engraved with “5” on one side
and “NVR” on the other.
Afinitor 10 mg tablets
White to slightly yellow, elongated tablets of approximately 15.1 mm
in length and 6.0 mm in width,
with a bevelled edge and no score, engraved with “UHE” on one side
and “NVR” on the other.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hormone receptor-positive advanced breast cancer
Afinitor 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
Afinitor 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
Afinitor is indicated for the treatment of unr