Apo-Megestrol

Valsts: Jaunzēlande

Valoda: angļu

Klimata pārmaiņas: Medsafe (Medicines Safety Authority)

Aktīvā sastāvdaļa:

Megestrol acetate 160mg

Pieejams no:

Apotex NZ Ltd

SNN (starptautisko nepatentēto nosaukumu):

Megestrol acetate 160 mg

Deva:

160 mg

Zāļu forma:

Tablet

Kompozīcija:

Active: Megestrol acetate 160mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose

Vienības iepakojumā:

Bottle, plastic, 75cc HDPE, PP cap & seal, 30 tablets

Klase:

Prescription

Receptes veids:

Prescription

Ražojis:

Farmabios SpA

Ārstēšanas norādes:

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).

Produktu pārskats:

Package - Contents - Shelf Life: Bottle, plastic, HDPE, PP cap & seal - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE,PP cap & seal - 100 tablets - 36 months from date of manufacture stored at or below 25°C

Autorizācija datums:

2001-12-03

Produkta apraksts

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