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SUSTANON INJECTION MSD ONLINE INDIA
Sustanon is a solution in oil. Each ampoule contains 1 ml arachis oil containing the following active substances:. All four components are esters of the natural hormone testosterone. The total amount of testosterone per ml is mg. Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests. Testosterone administration may also be used as supportive therapy for female-to-male transsexuals.
Safety and efficacy have not been adequately determined in children and adolescents. Pre-pubertal children treated with Sustanon should be treated with caution see section 4. Different specialist centres have used doses varying from one injection of 1ml every two weeks to one injection of 1ml every four weeks. Sustanon is therefore contraindicated in patients allergic to peanuts or soya see section 4. Testosterone level should be monitored at baseline and at regular intervals during treatment.
Clinicians should adjust the dosage individually to ensure maintenance of eugonadal testosterone levels. Physicians should consider monitoring patients receiving Sustanon before the start of treatment, at quarterly intervals for the first 12 months and yearly thereafter for the following parameters:. In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored regularly: In these patients hypercalcaemia or hypercalciuria may develop spontaneously, also during androgen therapy.
The latter can be indicative of a positive tumour response to the hormonal treatment. Nevertheless, the hypercalcaemia or hypercalciuria should first be treated appropriately and after restoration of normal calcium levels, hormone therapy can be resumed. In such cases treatment must be stopped immediately. Patients who experienced myocardial infarction, cardiac-, hepatic- or renal insufficiency, hypertension, epilepsy, or migraine should be monitored due to the risk of deterioration of or reoccurrence of disease.
Testosterone may cause a rise in blood pressure and Sustanon should be used with caution in men with hypertension. There have been reports that testosterone can cause or exacerbate pre-existing sleep apnoea. However, there is a lack of evidence regarding the safety of testosterone in men with the condition.
Good clinical judgment and caution should be employed in patients with risk factors such as adiposity or chronic lung diseases. If androgen-associated adverse reactions occur see section 4. Patients should be informed about the potential occurrence of signs of virilisation.
In particular, singers and women with speech professions should be informed about the risk of deepening of the voice. The voice changes may be irreversible. The misuse of androgens to enhance ability in sports carries serious health risks and is to be discouraged.
As there is a possible relationship between allergy to peanut and allergy to soya, patients with soya allergy should also avoid Sustanon see section 4. Sustanon contains mg benzyl alcohol per ml solution and must not be given to premature babies or neonates. Benzyl alcohol may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Before initiating Sustanon 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 check-ups are recommended of a frequency and nature adapted to the individual. The following should be monitored:. 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 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. In pre-pubertal children statural growth and sexual development should be monitored since androgens in general and Sustanon in high dosages may accelerate epiphyseal closure and sexual maturation.
There is limited experience on the safety and efficacy of the use of Sustanon in patients over 65 years of age. Currently, there is no consensus about age specific testosterone reference values.
However, it should be taken into account that physiologically testosterone serum levels are lower with increasing age. Testosterone should be used with caution in patients with thrombophilia, as there have been post-marketing studies and reports of thrombotic events in these patients during testosterone therapy. Enzyme-inducing agents may decrease and enzyme-inhibiting drugs may increase testosterone levels.
Therefore, adjustment of the dose of Sustanon may be required. Androgens may improve glucose tolerance and decrease the need for insulin or other anti-diabetic medicines in diabetic patients see section 4. Patients with diabetes mellitus should therefore be monitored especially at the beginning or end of treatment and at periodic intervals during Sustanon treatment. High doses of androgens may enhance the anticoagulant action of coumarin type agents see section 4.
Therefore, close monitoring of prothrombin time and if necessary a dose reduction of the anti-coagulant is required during therapy. The concurrent administration of testosterone with ACTH or corticosteroids may enhance oedema formation therefore these active substances should be administered cautiously, particularly in patients with cardiac or hepatic disease or in patients predisposed to oedema see section 4.
Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4.
Free thyroid hormone levels remain unchanged, and there is no clinical evidence of thyroid dysfunction. There are no adequate data for the use of Sustanon in pregnant women. In view of the risk of virilisation of the foetus, Sustanon should not be used during pregnancy see section 4. Treatment with Sustanon should be discontinued when pregnancy occurs. There are no adequate data for the use of Sustanon during lactation. Therefore, Sustanon should not be used during lactation.
In men treatment with androgens can lead to fertility disorders by repressing sperm-formation see section 4. In women treatment with androgens can lead to an infrequent or repressed menstrual cycle see section 4. Due to the nature of Sustanon side effects cannot be quickly reversed by discontinuing medication.
Injectables in general, may cause a local reaction at the injection site. Musculoskeletal and connective tissue disorders. The terms used to describe the undesirable effects above are also meant to include synonyms and related terms.
Treatment with Sustanon my induce signs of virilisation in women see section 4. Symptoms of virilisation may include hoarseness, acne, hirsutism, menstrual irregularity and alopecia. The following undesirable effects have been reported in prepubertal children using androgens see section 4. Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: If symptoms of chronic overdose occur e. Treatment of hypogonadal men with Sustanon results in a clinically significant rise of plasma concentrations of testosterone, dihydrotestosterone, estradiol and androstenedione, as well as decrease of SHBG Sex hormone binding globulin.
In hypogonadal men, treatment with Sustanon results in an improvement of testosterone deficiency symptoms. Moreover, treatment increases bone mineral density and lean body mass, and decreases body fat mass. Treatment also improves sexual function, including libido and erectile function. No clinically relevant changes in liver enzymes and PSA have been reported. Testosterone also produces systemic effects, such as increasing the retention of sodium, potassium and chloride leading to an increase in water retention.
Treatment may result in an increase in prostate size, and worsening of lower urinary tract symptoms, but no adverse effects on prostate symptoms have been observed. In boys with constitutional delay of growth and puberty, treatment with Sustanon accelerates growth and induces development of secondary sex characteristics.
In female-to-male transsexuals, treatment with Sustanon induces masculinisation. Sustanon contains four esters of testosterone with different durations of action.
The esters are hydrolysed into the natural hormone testosterone as soon as they enter the general circulation. Plasma testosterone levels return to the lower limit of the normal range in males in approximately 21 days. In female-to-male transsexuals, a single dose of Sustanon 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 to dihydrotestosterone and estradiol, which are further metabolised via the normal pathways. Preclinical data with androgens in general reveal no hazard for humans. The use of androgens in different species has been demonstrated to result in virilisation of the external genitals of female foetuses. A box of Sustanon contains 1 ampoule. Not all pack sizes may be marketed.
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