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HSA Approval

Androgel 25mg

SIN13161P

Androgel 25mg

Androgel 25mg

December 22, 2005

PHARMED IMPORT & EXPORT PTE LTD

PHARMED IMPORT & EXPORT PTE LTD

Regulatory Information

PHARMED IMPORT & EXPORT PTE LTD

PHARMED IMPORT & EXPORT PTE LTD

Therapeutic

Prescription Only

Formulation Information

GEL

**4.2** Posology and method of administration Cutaneous use. Adult and Elderly men The recommended dose is 5 g of gel (i.e. 50 mg of testosterone) applied once daily at about the same time, preferably in the morning. The daily dose should be adjusted by the doctor depending on the clinical or laboratory response in individual patients, not exceeding 10 g of gel per day. The adjustment of posology should be achieved by 2.5 g of gel steps. The application should be administered by the patient himself, onto clean, dry, healthy skin over both shoulders, and both arms and abdomen. After opening the sachets, the total contents must be extracted from the sachet and applied immediately onto the skin. The gel has just to be simply spread on the skin gently as a thin layer. It is not necessary to rub it on the skin. Allow drying for at least 3–5 minutes before dressing. Wash hands with soap and water after application. Do not apply to the genital areas as the high alcohol content may cause local irritation. Steady state plasma testosterone concentrations are reached approximately on the 2nd day of treatment by ANDROGEL. In order to adjust the testosterone dose, serum testosterone concentrations must be measured in the morning before application from the 3rd day on after starting treatment (and up to one week). The dose may be reduced if the plasma testosterone concentrations are raised above the desired level. If the concentrations are low, the dosage may be increased, not exceeding 10 g of gel per day. Children ANDROGEL is not indicated for use in children and has not been evaluated clinically in males under 18 years of age.

CUTANEOUS

Medical Information

**4.1** Therapeutic indications Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical signs and biochemical tests (see 4.4 Special warnings and precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

**4.3** Contraindications ANDROGEL is contraindicated: In cases of known or suspected prostatic cancer or breast carcinoma, in cases of known hypersensitivity to testosterone or to any other constituent of the gel.

Manufacturer Information

PHARMED IMPORT & EXPORT PTE LTD

Laboratoires Besins International

Besins Manufacturing Belgium

Active Ingredients

Testosterone 1%

0.025g

Testosterone

Documents

Package Inserts

Androgel 1%.pdf

Approved: September 4, 2020

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