Andriol Testocaps Capsules 40mg

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

TESTOSTERONE UNDECANOATE

Available from:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (International Name):

TESTOSTERONE UNDECANOATE

Units in package:

30Capsule Capsules; 120Capsule Capsules; 60Capsule Capsules

Manufactured by:

Catalent France Beinheim SA

Summary of Product characteristics

LPC -MK3033 -CP -072015 b 052017
ANDRIOL TESTOCAPS
Capsule
1. Name of the medicinal product
Andriol ® Testocaps ® 40 mg capsules 2. Qualitative and quantitative composition
Andriol Testocaps contain testoste rone undecanoate, a fatty acid ester of the natural
hormone testosterone. Each capsule contains 40 mg testosterone undecanoate
dissolved in a mixture of castor oil and propylene glycol laurate.
For excipients, see 6.1.
3. Pharmaceutical form
Capsules. Sof t oval glossy capsules, transparent, orange in colour, coded ORG DV3
containing a yellow oily fill.
4. Clinical particulars
4.1 Therapeutic indications
Testosterone replacement therapy in male s, for conditions associated with primary or
secondary hypogona dism (either congenital or acquired) when testosterone deficiency
has been confirmed by clinical features and biochemical tests .
4.2 Posology and method of administration
Posology
In general, the dose should be adjusted according to the response of the in dividual
patient.
Adult s
The initial dosage required will usually be 120 -160mg daily for 2 -3 weeks. Subsequent
dosage (40 -120mg daily) should be based on the clinical effect obtained during the first
weeks of therapy.
Elderly Patients