Provera HD

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Medroxyprogesterone acetate 400mg;  

Available from:

Pharmacia Limited Company trading as Pharmacia

INN (International Name):

Medroxyprogesterone acetate 400 mg

Dosage:

400 mg

Pharmaceutical form:

Tablet

Composition:

Active: Medroxyprogesterone acetate 400mg   Excipient: Docusate sodium Gelatin hydrolysate Isopropyl alcohol Macrogol 400 Magnesium stearate Maize starch Microcrystalline cellulose Purified water Sodium benzoate Sodium starch glycolate

Units in package:

Blister pack, PVC/Al/PVC, 30

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Pharmacia SAS

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Al/PVC - 30 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, - 30 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1969-12-31

Summary of Product characteristics

Version: pfdprovt10519
Supersedes: pfdprovt11016
Page 1 of 14 NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
_ _
PROVERA
®
2.5 mg, 5 mg, 10 mg, 100 mg and 200 mg tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PROVERA tablet contains 2.5 mg, 5 mg, 10 mg, 100 mg and 200 mg of
medroxyprogesterone
acetate (MPA) as the active ingredient.
MPA is a progestogen and a derivative of progesterone. It is a white
to off-white, odourless
crystalline powder, stable in air, melting between 200 and 210°C. It
is freely soluble in
chloroform, soluble in acetone and dioxane, sparingly soluble in
ethanol and methanol, slightly
soluble in ether and insoluble in water. MPA is 6
α
-methyl-3,20-dioxopregn-4-en-17
α
-yl
acetate.
EXCIPIENT(S) WITH KNOWN EFFECT
PROVERA 2.5 mg, 5 mg and 10 mg tablets:
•
Lactose monohydrate,
•
Sucrose,
PROVERA 100 mg and 200 mg tablets:
•
Isopropyl alcohol,
Sodium benzoate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
PROVERA 2.5 mg tablets are orange, circular, scored one side, marked
U64 on the other.
PROVERA 5 mg tablets are blue, circular, scored one side and marked
286 on both sides of the
score line, marked U on the other.
PROVERA 10 mg tablets are white, circular, scored marked UPJOHN 50.
PROVERA 100 mg tablets are white, scored, marked U467.
PROVERA 200 mg tablets are white, scored, marked U320.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PROVERA 2.5 MG, 5 MG AND 10 MG TABLETS
are indicated for
:
•
diagnosis of primary and secondary amenorrhoea
Version: pfdprovt10519
Supersedes: pfdprovt11016
Page 2 of 14
•
treatment of dysfunctional (anovulatory) uterine bleeding
•
opposition of endometrial effects of estrogen in menopausal women
being treated with
estrogen (hormone replacement therapy [HRT])
•
treatment of endometriosis.
PROVERA 100 MG AND 200 MG TABLETS
are indicated as adjunctive and/or palliative treatment
of recurrent and/or metastatic endometrial or renal carcinoma and, in
the treatment of
hormonally-dependent, recurrent breast cancer in post-me