Testosterone deficiency may be associated with a broad range of signs and symptoms * 1 , 2
Testosterone deficiency may be associated with a broad range of signs and symptoms * 1 , 2
*
� Depressed mood , impaired cognition , irritability
� Diminished energy , sense of vitality , or sense of well-being
� Sleep disturbances
� Diminished muscle mass and strength
� Decreased bone density
� Increased visceral fat
� Decrease in body hair and skin alterations
� Anaemia
� Increased fatigue
� Erectile dysfunction ( ED )
� Diminished libido
� Difficulty achieving orgasm
Adapted from Rhoden et al , 20042 and Nieschlag et al , 20063 .
� Only 10 – 30 % of men with Klinefelter ’ s are diagnosed clinically during their lifetime 3
Diagnosis of testosterone deficiency should be made only in men with consistent symptoms and signs and unequivocally low serum testosterone levels . 4
Reandron ® 1000 Minimum Product Information ) Reandron 1000 ( testosterone undecanoate ) 1000 mg / 4 mL , solution for injection . Indication : Testosterone replacement in primary and secondary male hypogonadism . Dose : 1 ampoule injected i . m every 10-14 weeks into gluteal muscle . The first injection interval may be reduced to a minimum of 6 weeks to achieve steady-state testosterone levels more rapidly . Contraindications : Androgen-dependent prostate / breast carcinoma , hypercalcaemia accompanying malignant tumours , hypersensitivity to testosterone undecanoate or the excipients , past or present liver tumours , use in women . Precautions : Regular prostate / breast and haemoglobin / haematocrit monitoring . Patients with diabetes , bleeding or coagulation disorder , predisposed to oedema , hypertension , epilepsy or migraine , severe cardiac / hepatic / renal insufficiency . Potentiation of pre-existing sleep apnoea . Effect on doping tests . Inject strictly i . m and very slowly to avoid pulmonary oily microembolism . Interactions : Hypoglycaemic agents , inducers of microsomal enzymes ( e . g . barbiturates ), oxyphenabutazone , cyclosporin , oral anticoagulants , thyroid laboratory tests . Adverse Effects : Polycythaemia , weight increased , acne , PSA increased , prostate examination abnormal , benign prostate hyperplasia , hot flush , various kinds of injection site reactions , suspected anaphylactic reactions . For other events refer to full PI . Minimum PI last updated 28 April 2011 . References : 1 . Rhoden EL & Morgentaler A . Risks of Testosterone-Replacement Therapy and Recommendations for Monitoring . N Engl J Med 2004 ; 350 ( 5 ): 482 – 92 . 2 . Nieschlag E et al . Investigation , Treatment , and Monitoring of Late-Onset Hypogonadism in Males : ISA , ISSAM , and EAU Recommendations . J Androl . 3 . Handelsman DJ & Zajac JD . Androgen deficiency and replacement therapy in men . Med J Aust 2004 ; 180 529 – 35 . 4 . Bhasin S et al . Testosterone Therapy in Men with Androgen Deficiency Syndromes : An Endocrine Society Clinical Practice Guideline . J Clin Endocrinol Metab , June 2010 , 95 ( 6 ): 2536 – 2559 . 2006 , 27 ( 2 ): 135 – 7 .
Please review full Product Information before prescribing . Full Product information is available from Bayer Australia Ltd .
Bayer Australia Ltd . ABN 22 000 138 714 , 875 Pacific Highway , Pymble NSW 2073 . ® Registered Trademark of Bayer AG , Germany . L . AU . WH . 03.2013.0351 . March 2013 .
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