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Testanone 250 mg Ampoule

1-Name of The Medicinal Product: 

Testonon 250mg/ml solution for injection

2-Qualitative and Quantitative Composition:

Testosterone propionate BP 30 mg/ml

Testosterone phenylpropionate BP  60 mg/ml

Testosterone isocaproate  BP 60 mg/ml

Testosterone decanoate BP 100 mg/ml

(eq to a total of 176 mg of testosterone)

3- Pharmaceutical Form:

Solution for injection.

4-Clinical Particulars:

4.1-Therapeutic Indications:

Testosterone replacement therapy in male hypogonadal disorders, for example:

After castration, Eunchoidism, Hypopitutarism, Endocrine impotence, Male climacteric symptoms like decreased libido, Certain types of infertility due to disorders of spermatogenesis.Testosterone therapy may also be indicated for the prevention and treatment of osteoporosis in hypogonadal males. Testosterone administration may also be used as supportive therapy for male-to-male transsexuals. Buy Testonon 250 mg Online

4.2- Posology and Method of Administration:

Dosage: In general, dosage should be adjusted to the individual response of the patient.

Adults: Usually, one injection of 1 ml per three weeks is adequate.

Elderly: It should be noted that smaller and less frequent doses may achieve the same response.

Children: It should be noted that smaller and less frequent doses may achieve the same response.

 Female-to-male transsexuals: Different specialist centers have used doses varying from one injection of 1 ml every  two weeks to one injection of 1ml evey four weeks. Buy Testonon 250 mg Online

 Administration:       Deep intramuscular injection

4.3- Contraindications:

Known or suspected prostatic or mammary carcinoma; Pregnancy, Breast-feeding, Hypersensitivity to the active substance or to any of the excipients.

4.4- Special warnings and precautions for use:

Patients, specially the elderly, with the following conditions should be monitored: Ischemic heart disease, since androgens may produce hypercholesterolemia. Latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine (or history of these conditions), since androgens may occasionally induce fluid and sodium retention. Skeletal metastases, since androgens may induce hypercalcaemia or hypercalciuria in these patients. Long term monitoring should include measurement of hemoglobin.The use of steroids may influence the results of certain laboratory tests. Androgens should be used cautiously in prepubertal boys to avoid premature epiphyseal closure or precocious  sexual development. If androgen-associated adverse reactions occur, Testonon  250 treatment should be interrupted and after disappearance of the symptoms, be resumed at a lower dosage. Buy Testonon 250 mg Online

Testonon 250 contains Arachis oil (peanut oil) and should not be taken/ applied by patients known to be allergic to    peanut, as there is possible relationship between allergy to peanut and allergy to Soya, patients with Soya allergy should also avoid Testonon 250.

Female-to-male transsexual supportive therapy:

Before initiating Testonon for female -to-male transsexuals, specialist assessment should be undertaken, including psychiatric assessment. A complete personal and medical history should be taken, during treatment, periodic checkups  are recommended of a frequency and nature adapted to the individual, the following should be monitored

signs of osteoporosis,

changes in lipid profile.

In patients with a personal or family history of breast cancer and with a personal history of endometrial cancer careful monitoring should be undertaken. Subject to specialist advice, hysterectomy and bilateral oophorectomy should be considered after 18-24 months of testosterone treatment, to reduce the possible increased risk of endometrial and ovarian cancer Continued surveillance is required to detect osteoporosis in patients who have undergone oophorectomy as testosterone may not fully reverse the decline in bone density in these patients. Continued surveillance is required to detect endometrial and ovarian cancer in patients on long term treatment who have not proceeded to hysterectomy and bilateral oophorectomy. Buy Testonon 250 mg Online

Do not administer injections preserved with benzyl alcohol to neonates, infants, pregnant women or nursing mothers. Benzyl alcohol has been associated with serious adverse events and death, particularly in pediatric patients. Injections preservative free should be sued in these populations.

Testonon 250 decreases sperm counts and causes hepatotoxicity in supra physiologic doses.

4.5- Interaction with other medicinal products and other forms of interaction

Enzyme-inducing agents may exert increasing or decreasing effects on testosterone levels. Therefore adjustment of the dose, and /or intervals between injections may be required. Buy Testonon 250 mg Online

4.6- Pregnancy and Lactation

On the basis of its pharmacological effect, Testonon 250 is suspected to cause birth defects and/or other irreversible adverse effects on pregnancy outcome. Therefore, Testonon 250 is contraindicated during pregnancy and lactation.

4.7- Effect on ability to drive and use machines

As far as is known Testonon 250 has no influence on alertness and concentration.

Undesirable effects

The following adverse reactions have been associated with androgen therapy in general:

In perpubertal boys, precocious sexual development, an increased frequency of erections, phallic enlargement and premature epiphyseal closure. Priapism and other signs of excessive sexual stimulation. Buy Testonon 250 mg Online

Water and sodium retention.

Oligospermia and a decreased ejaculatory volume.

Treatment should be interrupted until these symptoms have disappeared, after which it should be continued at a lower dosage.Hoarseness of the voice may be the first symptom of vocal change which may lead to irreversible lowering of

the voice. If signs of virilisation develop, particularly lowering of the voice, treatment should be discontinued unless

the effects are desired treatment outcomes.

The following undesirable effects have also been observed:

Acne, Disturbance of liver function, Polycythemia, Hypertension,Weight gain (in female-to-male transsexuals)

4.9- Overdose:

The acute intramuscular toxicity of Testonon 250 is very low, priapism in men is a symptom of chronic overdose. If this occurs, Testonon treatment should be interrupted and, after disappearance of the symptom, be resumed at a lower dose. Buy Testonon 250 mg Online

5- Pharmacological Properties:

5.1- parmacodynamic Properties:

ATC code: GO3B A urogenital system (including sex hormones).Testosterone is the principal endogenous hormone essential for normal growth and development of the male sex organs and male secondary sex characteristics. During adult life testosterone is essential for the functioning of the testes and accessory structures, and for the maintenance of libido, sense of well-being, erectile potency, and seminal vesicle function.

Treatment of hypogonadal males with Testonon 250 results in a clinically significant rise of plasma concentrations of  testosterone, dihydrotestosterone and androstenedione, as well as a decrease of SHBG (sex hormone building globulin). In the males with primary (hypergonadotropic) hypogonadism treatment with Testonon results in a normalisaion of pituitary function. Buy Testonon 250 mg Online

5.2- Pharmacokinetic Properties:

Testonon 250 contains a number of esters of testosterone with different duration of action. The esters are hydrolyzed into the natural hormone testosterone, as soon as they enter the general circulation.

A single dose of Testonon 250 in males leads to an increase of total plasma testosterone, with peak level reached approximately 24-48hrs (tmax) after administration. Plasma testosterone levels return to the lower limit of the normal range in males afer approximately 21 days.

In female-to-male transsexuals, a single dose of testonon 250 repeated every two weeks resulted in mean trough     testosterone levels towards the upper end of the normal male range at 2,4 and 12 months.

Testosterone is metabolised via the normal pathways. Excretion mainly takes place via the urine as conjugates of etiocholanolone and androsterone. Buy Testonon 250 mg Online

5.3- Preclinical Safety Data:

Not applicable

6-Pharmaceutical Particulars:

6.1- List of Exciepients:

Benzyl alcohol.BP, Arachis oil BP

6.2- Incompatibilities: Not applicable.

6.3- shelf life: 3 years.

6.4- Special precautions for storage:

Do not store above 25ºC.

Do not refrigerate or freeze.

Store the ampoules in the outer carton.

6.5- Nature and contents of the container: 1 ml ampoule in carton box.

6.5- Special precautions for disposal and other handling: No special requirements.

 

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