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

cipla usa inc. - testosterone cypionate (unii: m0xw1ubi14) (testosterone - unii:3xmk78s47o) - testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. - primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. - hypogonadotropic hypogonadism (congenital or acquired)-gonadotropin or lhrh deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. safety and efficacy of testosterone cypionate in men with "age -related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established. - known hypersensitivity to the drug - males with carcinoma of the breast - males with known or suspected carcinoma of the prostate gland - women who are pregnant (see precautions, pregnancy) - patients with serious cardiac, hepatic or renal disease (see warnings) controlled substance testosterone cypionate injection contains testosterone, a schedule iii c

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

proficient rx lp - testosterone cypionate (unii: m0xw1ubi14) (testosterone - unii:3xmk78s47o) - testosterone cypionate injection, usp is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. safety and efficacy of testosterone cypionate in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. testosterone cypionate injection contains testosterone, a schedule iii controlled substance in the controlled substances act. abuse 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 event

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

asclemed usa, inc. - testosterone cypionate (unii: m0xw1ubi14) (testosterone - unii:3xmk78s47o) - testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. hypogonadotropic hypogonadism (congenital or acquired) - gonadotropin or lhrh deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. safety and efficacy of testosterone cypionate in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established. - known hypersensitivity to the drug - males with carcinoma of the breast - males with known or suspected carcinoma of the prostate gland - women who are pregnant (see precautions, pregnancy) - patients with serious cardiac, hepatic or renal disease (see warnings) testosterone cypionate injection contains testosterone, a schedul

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

perrigo new york inc - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone 12.5 mg in 1.25 g - testosterone gel is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: limitations of use: pregnancy category x [see contraindications (4) ]: testosterone gel is contraindicated during pregnancy or in women who may become pregnant. testosterone is teratogenic and may cause fetal harm. exposure of a female fetus to androgens, such as testosterone, may result in varying degrees of virilization. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. although it is not known how much testosterone transfers into human milk, testosterone gel is contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants. testosterone and other androgens may adversely affect lactation. [see contraindications (4) ]. safety and efficacy of testosterone gel in pediatric males less than 18 years old ha

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

par pharmaceutical, inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone 10 mg in 0.5 g - testosterone gel is indicated for replacement therapy in 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, heavy metals. these men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone [fsh] and 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 serum testosterone concentrations 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 hypogona

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

Malta - English - Medicines Authority

bayer limited 1st floor the grange offices the grange brewery road stillorgan co. dublin, a94 h2k7 , ireland - testosterone undecanoate - solution for injection - testosterone undecanoate 250 mg/ml - sex hormones and modulators of the genital system

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

eugia us llc - testosterone enanthate (unii: 7z6522t8n9) (testosterone - unii:3xmk78s47o) - males testosterone enanthate injection is indicated for replacement therapy in 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, or orchidectomy. hypogonadotropic hypogonadism (congenital or acquired) – gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. (appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.) if the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty. safety and efficacy of testosterone enanthate injection in men with age-related hypogonadism have not been established. delayed puberty – testosterone enanthate injection may be used to stimulate puberty in carefully selected males with clearly delayed puberty. these patients usually have a familial pattern of delayed puberty that is not secondary to a pathological disorder; puberty is expected to occur spontaneously at a relatively late date. brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. the potential adverse effect on bone maturation should be discussed with the patient and parents prior to androgen administration. an x-ray of the hand and wrist to determine bone age should be obtained every six months to assess the effect of treatment on the epiphyseal centers (see warnings ). females metastatic mammary cancer – testosterone enanthate injection may be used secondarily in women with advancing inoperable metastatic (skeletal) mammary cancer who are one to five years postmenopausal. primary goals of therapy in these women include ablation of the ovaries. other methods of counteracting estrogen activity are adrenalectomy, hypophysectomy, and/or antiestrogen therapy. this treatment has also been used in premenopausal women with breast cancer who have benefited from oophorectomy and are considered to have a hormone-responsive tumor. judgment concerning androgen therapy should be made by an oncologist with expertise in this field. androgens are contraindicated in men with carcinomas of the breast or with known or suspected carcinomas of the prostate and in women who are or may become pregnant. when administered to pregnant women, androgens cause virilization of the external genitalia of the female fetus. this virilization includes clitoromegaly, abnormal vaginal development, and fusion of genital folds to form a scrotal-like structure. the degree of masculinization is related to the amount of drug given and the age of the fetus and is most likely to occur in the female fetus when the drugs are given in the first trimester. if the patient becomes pregnant while taking androgens, she should be apprised of the potential hazard to the fetus. this preparation is also contraindicated in patients with a history of hypersensitivity to any of its components. testosterone enanthate injection contains testosterone, a schedule iii controlled substance in the controlled substances act. 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 of 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.

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

aspen pharma trading limited (aptl), ireland - testosterone decanoate,testosterone isocaproate,testosterone phenylpropionate,testosterone propionate - solution for injection - 100,60,60,30 mg,

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

organon - testosterone deconate, testosterone isocaproat, testosterone phenylpropionate, testosterone propionate - solution - 30, 60, 60, 100 mg/ml