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

hikma pharmaceuticals usa inc. - testosterone enanthate (unii: 7z6522t8n9) (testosterone - unii:3xmk78s47o) - testosterone enanthate 200 mg in 1 ml - testosterone enanthate injection, usp 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 testost

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

actavis pharma, inc. - testosterone enanthate (unii: 7z6522t8n9) (testosterone - unii:3xmk78s47o) - testosterone enanthate 200 mg in 1 ml - 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 testo

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

antares pharma, inc. - testosterone enanthate (unii: 7z6522t8n9) (testosterone - unii:3xmk78s47o) - xyosted (testosterone enanthate) injection 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'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 xyosted in males less than 18 years old have not been established [see use in specific populations (8.4)] . xyosted is contraindicated in: - men 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)] . - men with known hypersensitivity to xyosted or any of its ingredients (testosterone enanthate and sesame oil). - men with hypogonadal conditions, such as “age-related hypogonadism”, that are not associated with structural or genetic etiologies. the efficacy of xyosted has not been established for these conditions, and xyosted can increase bp that can increase the risk of mace [see boxed warning and warning and precautions (5.1)]. risk summary xyosted is contraindicated in pregnant women. testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies and its mechanism of action [see contraindications (4) and 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 ano-genital 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 xyosted is not indicated for use in females. infertility during treatment with large doses of exogenous androgens, including xyosted, 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. safety and effectiveness of xyosted 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 xyosted to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. of the 283 patients enrolled in the 6-month and one-year efficacy and safety clinical study utilizing xyosted, 49 (17%) were over 65 years of age. additionally, there are insufficient long-term safety data in geriatric patients 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 [see warnings and precautions (5.4)]. xyosted 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 doses 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. ​xyosted​tm testosterone enanthate injection usp ciii single-use. for subcutaneous injection. administer one device weekly. read this instructions for use before you start using xyosted (zye-oh-sted) and each time you get a refill. there may be new information. this leaflet does not take the place of talking with your healthcare provider about your medical condition or treatment. important information about xyosted: - use xyosted exactly as your healthcare provider tells you to take it. - inject xyosted only 1 time each week. do not use xyosted every day. - your healthcare provider will show you or your caregiver how to inject xyosted. you should not inject xyosted until you have been trained on the proper way to use it. - check xyosted before you inject it. xyosted should be clear to light yellow in color and should be free of visible particles. - do not use if the liquid is cloudy or if visible particles are present. you may see air bubble(s), this is normal. - do not use xyosted if the safety seal is broken or if the auto-injector appears broken, damaged or changed in any way. - xyosted should be injected in the stomach (abdomen) area after cleaning the skin. - do not inject xyosted within 2 inches of the belly button (navel). - do not inject xyosted in any other areas of the body. - do not inject xyosted in areas where the skin is tender, bruised, red, scaly, hard, or has scars or stretch marks. if you are not sure if xyosted was injected, or if you have a hard time giving the injection, do not inject another dose. call your pharmacist or healthcare provider right away. if you need help or instructions, call: 1-844-996-7833 - carefully read all steps before beginning injection. - injection process must be completed without interruption. ​supplies you will need - 1 xyosted auto-injector - 1 alcohol swab - 1 cotton ball or gauze ​storage conditions - do not refrigerate or freeze. - protect from light. - use at room temperature. - store at 68° - 77° f (20° - 25° c). - keep xyosted and all medicines away from children. ​inspect auto-injector - do not remove cap until ready to inject. - inspect auto-injector for any visible damage. do not use if it appears damaged or broken. - check the expiration date. do not use if the expiration date has passed. - inspect the medicine through the viewing window; it should be clear to light yellow and free of visible particles (see figure 2 ). do not use if the medicine is cloudy or if visible particles are present. you may notice an air bubble, this is normal. ​select & prep injection site wash your hands with soap and water. wipe the abdomen injection site with an alcohol swab. allow the site to dry on its own. do not fan or blow on the injection site. do not touch the site again before injecting. only use the left or right side of the abdomen (belly) for injection sites. do not use the area within 2 inches around your navel (belly button). see figure 3. do not use in areas where the skin is tender, bruised, red, scaly, or hard. avoid areas with scars, tattoos, or stretch marks. ​administering injection 1. remove cap twist the cap to remove (this will also break the red safety seal). see figure 4. after the cap is removed, a few drops of liquid may appear, this is normal. the auto-injector should be used or discarded after the cap is removed. do not re-cap for later use. do not touch the needle end of the auto-injector with your hand or fingers after the cap is removed, doing so can cause injection and injury to your hands. ​2. position auto-injector gently squeeze the abdomen injection site to create a raised area and hold that area firmly until after the injection is complete (see figure 5 ). place the needle end of the auto-injector on the abdomen injection site. keep the auto-injector straight at a 90 degree angle to the abdomen injection site. (see figure 6 ). 3. inject & hold down firmly push the auto-injector down on the abdomen site and continue to hold down after you hear the “click” (see figure 7 ). while holding the xyosted auto-injector down, slowly count from 1 to 10 to allow all of the medicine to be delivered (see figure 8 ). keep holding the xyosted auto-injector down for a total of 10 seconds even if your injection is complete and the viewing window turns orange sooner. it is normal if there is slight bleeding from the site after injection. if this occurs, hold a cotton ball or gauze on the area for a few seconds. do not rub the area. ​4. inspect viewing window after injecting, inspect the viewing window. it should be orange, confirming the dose was administered (see figure 9 ). if the viewing window is not orange: - do not use another auto-injector. - do not attempt another injection. - call your healthcare provider or 1-844-996-7833 for assistance. ​disposal after injection after completing your injection, dispose of the xyosted auto-injector and cap in an fda-cleared sharps disposal container immediately after use. do not dispose of the xyosted auto-injector in your household trash. if you do not have an fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out - upright and stable during use - leak-resistant - properly labeled to warn of hazardous waste inside the container when your sharps disposal container is almost full, you will need to follow your community guidelines for the proper way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal. do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. this instructions for use has been approved by the u.s. food and drug administration lb-0118 v6 manufactured for: antares pharma, inc. ewing, nj 08628 08/2023

Malta - English - Malta Medicines Authority

norma hellas s.a. 54 menandrou str. gr-104 31 athens, greece - testosterone enanthate - solution for injection - testosterone enanthate 250 mg/ml - sex hormones and modulators of the genital system

Canada - English - Health Canada

hikma canada limited - testosterone enanthate - solution - 200mg - testosterone enanthate 200mg

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.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

jurox pty limited - testosterone enanthate - unknown - testosterone enanthate steroid-anabolic active 0.0 - active constituent

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

jurox pty limited - testosterone enanthate - parenteral liquid/solution/suspension - testosterone enanthate steroid-anabolic active 75.0 mg - endocrine system - sheep wether (castrated male) | castrated male | ovine - external preputial ulceration | sheath rot

Canada - English - Health Canada

squibb canada inc., division of bristol-myers squibb canada inc. - fluphenazine enanthate - liquid - 25mg - fluphenazine enanthate 25mg - phenothiazines

Canada - English - Health Canada

taro pharmaceuticals inc - testosterone enanthate - liquid - 200mg - testosterone enanthate 200mg - androgens