Product Name: Testosterone Undecanoate
Description:
Testosterone Undecanoate is a long-acting androgen formulation presented as a sterile oily solution for intramuscular injection. It is indicated for the treatment of clinical conditions associated with testosterone deficiency.
Composition:
Each 1 mL ampoule contains 250 mg of testosterone undecanoate as the active substance.
Excipients include flaxseed oil, benzyl alcohol, and benzyl benzoate.
Pharmaceutical Form:
Sterile oily solution for deep intramuscular administration.
Packaging:
Pack of 10 ampoules, each containing 1 mL of solution.
Pharmacotherapeutic Classification:
Androgenic hormones (ATC Code: G03BA03)
Therapeutic Indications:
Testosterone undecanoate is indicated as testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). This includes both primary and secondary hypogonadism confirmed by clinical features and laboratory tests.
Dosage and Administration:
Administer by deep intramuscular injection, typically in the gluteal muscle. Due to its long-acting nature, testosterone undecanoate may be administered at extended dosing intervals under medical supervision. Dosage and administration frequency should be individualized based on therapeutic response and serum testosterone concentrations.
Storage Conditions:
Store at temperatures below 25°C. Do not freeze. Protect from light by keeping the ampoules in their original packaging.
Keep out of reach of children.
Regulatory Status:
Prescription-only medicine (Rx).
Manufactured in accordance with current Good Manufacturing Practice (cGMP) guidelines.