Apo-Megestrol

देश: न्यूज़ीलैंड

भाषा: अंग्रेज़ी

स्रोत: Medsafe (Medicines Safety Authority)

सक्रिय संघटक:

Megestrol acetate 40mg

थमां उपलब्ध:

Apotex NZ Ltd

INN (इंटरनेशनल नाम):

Megestrol acetate 40 mg

डोज़:

40 mg

फार्मास्यूटिकल फॉर्म:

Tablet

रचना:

Active: Megestrol acetate 40mg Excipient: Brilliant blue FCF Colloidal silicon dioxide Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose

पैकेज में यूनिट:

Bottle, plastic, HDPE, PP cap & seal, 100 tablets

वर्ग:

Prescription

प्रिस्क्रिप्शन प्रकार:

Prescription

द्वारा बनाया गया:

Farmabios SpA

चिकित्सीय संकेत:

Apo-Megestrol is indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (i.e. recurrent, inoperable or metastatic diseases). It should not be used in lieu of currently accepted procedures such as surgery, radiation or chemotherapy. Apo-Megestrol is indicated for the treatment of anorexia, cachexia, or a significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).

उत्पाद समीक्षा:

Package - Contents - Shelf Life: Bottle, plastic, HDPE, PP cap & seal - 100 tablets - 24 months from date of manufacture stored at or below 25°C

प्राधिकरण की तारीख:

2001-12-03

उत्पाद विशेषताएं

NEW ZEALAND DATA SHEET
APO-MEGESTROL USP
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1 of 8
1. PRODUCT NAME
APO-MEGESTROL 40mg & 160mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Megestrol acetate 40mg
Megestrol acetate 160mg
EXCIPIENT(S) WITH KNOWN EFFECT
Contains lactose.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
APO-MEGESTROL 40mg: light blue, round, flat-faced, bevelled edge,
scored tablets, engraved “APO”
over “40” on one side, containing 40mg megestrol acetate
APO-MEGESTROL 160 mg: white, oval, biconvex, scored tablets, engraved
“APO 160" on one side,
containing 160mg megestrol acetate.
Please note: Not all strengths are marketed.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
APO-MEGESTROL is indicated for the palliative treatment of advanced
carcinoma of the breast or
endometrium (i.e. recurrent, inoperable or metastatic diseases). It
should not be used in lieu of currently
accepted procedures such as surgery, radiation or chemotherapy.
APO-MEGESTROL is indicated for the treatment of anorexia, cachexia, or
a significant weight loss in
patients with a diagnosis of acquired immunodeficiency syndrome
(AIDS).
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
BREAST CANCER
160mg/day (160mg taken once daily).
At least two months of continuous treatment is considered an adequate
period for determining the
efficacy of megestrols
Best results are obtained in previously untreated receptor-positive
cases that are more than five years
post-menopausal (approximately 40% response rate). In patients with
less favourable characteristics
the response rate could be 15% or less.
ENDOMETRIAL CARCINOMA
40 – 320mg/day in divided doses (40 – 80mg one to four times daily
or one to two 160mg tablets daily).
At least two months of continuous treatment is considered an adequate
period for determining the
efficacy of megestrol
APO-MEGESTROL
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 2 of 8
CACH