AROMASIN 25 Milligram Coated Tablets
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
16-04-2024
Unele documente pentru acest produs nu sunt disponibile în prezent, puteți trimite o solicitare la serviciul nostru pentru clienți și vă vom anunța de îndată ce vom putea să le obținem.
Trimite cerere.
Trimite cerere.
Ingredient activ:
EXEMESTANE
Disponibil de la:
Haemato Pharm AG
Codul ATC:
L02BG06
INN (nume internaţional):
EXEMESTANE
Dozare:
25 Milligram
Forma farmaceutică:
Coated Tablets
Tip de prescriptie medicala:
Product subject to prescription which may not be renewed (A)
Zonă Terapeutică:
Aromatase inhibitors
Statutul autorizaţiei:
Authorised
Data de autorizare:
2012-11-30
Caracteristicilor produsului
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aromasin 25 mg coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance: exemestane
Each coated tablet contains 25 mg exemestane.
Each tablet contains 30.2mg of sucrose and 0.003mg of methyl parahydroxybenzoate (E218).
For a full list of Excipients, see section 6.1
3 PHARMACEUTICAL FORM
Coated tablet
_Product imported from Italy:_
Round, biconvex, off-white coated tablet marked 7663 on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Aromasin is indicated for the adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive
early breast cancer, following 2 – 3 years of initial adjuvant tamoxifen therapy.
Aromasin is indicated for the treatment of advanced breast cancer in women with natural or induced postmenopausal
status whose disease has progressed following anti-oestrogen therapy. Efficacy has not been demonstrated in patients
with oestrogen receptor negative status.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adult and elderly patients
The recommended dose of Aromasin is one 25 mg tablet to be taken once daily, preferably after a meal.
In patients with early breast cancer, treatment with Aromasin should continue until completion of five years of
combined sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin), or earlier if tumour relapse occurs.
In patients with advanced breast cancer, treatment with Aromasin should continue until tumour progression is evident.
No dose adjustments are required for patients with hepatic or renal insufficiency _(see section 5.2, Pharmacokinetic_
_Properties)._
Children
Not recommended for use in children.
4.3 CONTRAINDICATIONS
Aromasin tablets are contraindicated in patients with a known hypersensitivity to the active su
Citiți documentul complet
