United States - English - NLM (National Library of Medicine)

endo pharmaceuticals inc. - testosterone undecanoate (unii: h16a5vct9c) (testosterone - unii:3xmk78s47o) - testosterone undecanoate 250 mg in 1 ml - aveed is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. - primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. these men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [fsh], luteinizing hormone [lh]) above the normal range. - hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. these men have low testosterone serum concentrations but have gonadotropins in the normal or low range. aveed should only be used in patients who require testosterone replacement therapy and in whom the benefits of the product outweigh the serious risks of pome

Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - testosterone undecanoate, quantity: 1000 mg - injection - excipient ingredients: benzyl benzoate; castor oil - testosterone replacement in primary and secondary male hypogonadism.

Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - testosterone undecanoate, quantity: 1000 mg - injection - excipient ingredients: benzyl benzoate; castor oil - testosterone replacement in primary and secondary male hypogonadism.

United States - English - NLM (National Library of Medicine)

tolmar inc. - testosterone undecanoate (unii: h16a5vct9c) (testosterone - unii:3xmk78s47o) - jatenzo (testosterone undecanoate) is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: - primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. these men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [fsh], luteinizing hormone [lh]) above the normal range. - hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. these men have low testosterone serum concentrations but have gonadotropins in the normal or low range. limitations of use: - safety and efficacy of jatenzo in males less than 18 years old have not been established [see u

United States - English - NLM (National Library of Medicine)

antares pharma, inc. - testosterone undecanoate (unii: h16a5vct9c) (testosterone - unii:3xmk78s47o) - tlando is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: - primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. these men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone (fsh), luteinizing hormone (lh)) above the normal range [see dosage and administration (2.2 )]. - hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. these men have low testosterone serum concentrations but have gonadotropins in the normal or low range [see dosage and administration (2.2 )]. limitations of use safety and efficacy of tlando in males less than 18 years old have not been established [see use in specific populations (8.4) ] . tlando is contraindicated in: - patients with carcinoma of the breast or known or suspected carcinoma of the prostate [see warnings and precautions ( 5.4)] . - women who are pregnant. testosterone can cause virilization of the female fetus when administered to a pregnant woman [see use in specific populations ( 8.1)] . - known hypersensitivity to testosterone undecanoate or any of tlando’s ingredients [see description ( 11)]. - men with hypogonadal conditions, such as “age-related hypogonadism”, that are not associated with structural or genetic etiologies. the efficacy of tlando has not been established for these conditions, and tlando can increase bp that can increase the risk of mace [see boxed warning and warning and precautions (5.1 )] . risk summary tlando is contraindicated in pregnant women and not indicated for use in females [ see contraindications (4)] . testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies (see data) and its mechanism of action [ see clinical pharmacology (12.1) ] . exposure of a female fetus to androgens may result in varying degrees of virilization. in animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. these studies did not meet current standards for nonclinical development toxicity studies. data animal data in developmental studies conducted in rats, rabbits, pigs, sheep and rhesus monkeys, pregnant animals received intramuscular injection of testosterone during the period of organogenesis. testosterone treatment at doses that were comparable to those used for testosterone replacement therapy resulted in structural impairments in both female and male offspring. structural impairments observed in females included increased anogenital distance, phallus development, empty scrotum, no external vagina, intrauterine growth retardation, reduced ovarian reserve, and increased ovarian follicular recruitment. structural impairments seen in male offspring included increased testicular weight, larger seminal tubular lumen diameter, and higher frequency of occluded tubule lumen. increased pituitary weight was seen in both sexes. testosterone exposure in utero also resulted in hormonal and behavioral changes in offspring. hypertension was observed in pregnant females and offspring in rats exposed to doses approximately twice those used for testosterone replacement therapy. risk summary tlando is not indicated for use in females. infertility males during treatment with large doses of exogenous androgens, including tlando, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis [ see warnings and precautions (5.8) ] . reduced fertility is observed in some men taking testosterone replacement therapy. the impact on fertility may be irreversible. testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids [ see drug abuse and dependence (9.2) ] . the safety and effectiveness of tlando in pediatric patients less than 18 years old have not been established. improper use may result in acceleration of bone age and premature closure of epiphyses. there have not been sufficient numbers of geriatric patients in controlled clinical studies with tlando to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. of the 95 patients enrolled in study 16-002, the 24-day major safety and effectiveness study utilizing tlando, 16 (16.8%) were over 65 years of age.  additionally, there is insufficient long-term safety data in geriatric patients utilizing tlando to assess the potentially increased risk of cardiovascular disease and prostate cancer. geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of bph and hypertension [see warnings and precautions (5.1)] and 5.4]. tlando contains testosterone undecanoate, a schedule iii controlled substance. drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. abuse and misuse of testosterone are seen in male and female adults and adolescents. testosterone, often in combination with other anabolic androgenic steroids (aas), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. there have been reports of misuse by men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice. abuse-related adverse reactions serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression. the following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility. the following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities. the following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty. because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. behaviors associated with addiction continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors: - taking greater dosages than prescribed - continued drug use despite medical and social problems due to drug use - spending significant time to obtain the drug when supplies of the drug are interrupted - giving a higher priority to drug use than other obligations - having difficulty in discontinuing the drug despite desires and attempts to do so - experiencing withdrawal symptoms upon abrupt discontinuation of use physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism. drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - testosterone undecanoate, quantity: 40 mg - capsule, soft - excipient ingredients: propylene glycol monolaurate; hydrogenated castor oil; medium chain triglycerides; gelatin; sunset yellow fcf; lecithin; glycerol; titanium dioxide; propylene glycol; ethyl acetate; isopropyl alcohol; purified water; ethanol; strong ammonia solution; polyvinyl acetate phthalate; macrogol 400 - androgen replacement therapy for confirmed testosterone deficiency in males, when testosterone deficiency has been confirmed by clinical features and biochemical tests.

Israel - English - Ministry of Health

bayer israel ltd - testosterone undecanoate - solution for injection - testosterone undecanoate 250 mg/ml - testosterone - testosterone - testosterone replacement therpay in primary and secondary male hypogonadism.

Ireland - English - HPRA (Health Products Regulatory Authority)

besins healthcare ireland limited - testosterone undecanoate - solution for injection - testosterone

United States - English - NLM (National Library of Medicine)

upsher-smith laboratories, llc - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone 50 mg in 5 g - testosterone gel is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: - primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. these men usually have low serum testosterone levels and gonadotropins (follicle-stimulating hormone [fsh], luteinizing hormone [lh]) above the normal range. - hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. these men have low testosterone serum levels but have gonadotropins in the normal or low range. limitations of use: - safety and efficacy of testosterone gel in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.

United States - English - NLM (National Library of Medicine)

actavis pharma, inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone 10 mg in 1 g - testosterone gel 1% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: - primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. these men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [fsh], luteinizing hormone [lh]) above the normal range. - hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. these men have low testosterone serum concentrations, but have gonadotropins in the normal or low range. limitations of use: - safety and efficacy of testosterone gel 1% in men with “age-related hypogonadism” (also referred to as “late-onset