Indications and usage:
Treatment of ipozonadal men with lestosterone Mix injection 230m /mi results in a clinical sanitkant rise of plasma concentrations of estradiol and androstenedione, as well as decrease of Sk8G Sex hormone binding, gobun).Luteinking, hormone (CH) and lol cle-stimulating hormone (Sh) are restored to the normal range. In hypogonadal men, treatment with restosterone Mix injection _some/mi results in an improvement of testosterone deficiency symptoms. Moreover, treatment increases bone mine ldensynjenyne.
ent also improves sexual function, including libido and erectile function, Treatment decreases serum (DLC. HOL Gand triglycerides and increast.No clinical relevant changes in liver enzymes and intion of sodium, potassium and chloride leading to an orsenine of lower urinary tract symptoms, but no doverse enees on prostate symptoms have been observed. In hypogonadal diabetic patients, improvement of insulin sensitivity and/or reduction in blood gucox have been reported with the use of androgens, In boys with constitutiona dewy of growth and puberty, treatment with restosterone wat in ection characteristics. in female-to-male transsexuals, treatment with -durationsofactionheesters are hydrolysed into the natural A sinele dose of Testosterone Mix iniection 250m/mileads to an increase of total diasma testosterone with peak levels of approximately /Unmol (cmax), whichare reached approximately 24-48 h (tmax) after administration, Plasma testosterone levels return to the lower limit of the normal range infemale-to-male.transsexuals,as ingledose of Testosterone Mixinjection250mR/mirepeated every two weeks resulted in mean trougn testosterone towards the upperend of the normal maleraneest2-4and 12 months(over9)In specific bindine to plasma proteins and sex hormone binding globulin in in vitrotests Biotransformation:
Testoderone is metabolisedtodinvdi testosterone and estradio…whicharefur the rmetabolisedva the normal path way.
Excretion mainly takes place via the urine as conjugates of etiocholanalone and androsterone.
INDICATIONS:
Testosterone replacement therapy for male hypozonadism, when testosterone deficiency has been confirmed by clinical features and biochemical resis.-lestosteron@administration mavalsobe used as supportive the
raoyforfemala-to-malatantank Known or suspected caranoma or breast Breast-feeding,Hypersensitivity to the active substance of to any of the excipients including arachis oil, Testosterone Mix In ection 250m2/mi is therefore contraindicated in patents allergic to peanut or soyd vel should be monitored at baseline and at regular intervals during treatment. Clinicians should adjust the dosage individualiy to ensure maintenance of eugonadal testosterone levels Physicians chould consider monitoring patients receiving Testosterone Mix injection 250m/ml before the start of treatment. at Quarterly interval for the first12 months and yearly
thereatter for the following parameters:Dipital rectal examination tORE) of the prostate and PSA to exclude benien prostate hvperolasia or a sub-clinicaloin patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored regularly: haemoglobin, and need supervision Patients, especialy the elder with the following conditions should be monitored for:Tumours – Mammary carcinoma, hypernegaroma, bronchial carcinoma and skeletal metastases. In these patients hypercalcaemia or hypercalciuria spontaneously, also during androgen therapy. The latter can be indicative of a positive tumour response to the hormonal treatment.
the hypercalcdemia of hypercalcuria should first be treated appropriately and alter restoration of normal
Pre-existine conditions.
In patents suffering from severe cardiac hepatic or renal insufficiency or ischaemicheart disease, treatment with testosterone may cause severe complicatons characterised by oedema with or without congestive card at failure. In such caces treatment must bestoppedimmediately. Patients who experienced myocardial infarction, cardiac, hepatic or renal insulticiency, Iypertension, epilepsy, or migraine shoube monitored due to the risk o deterioration of or reoccurrence of disease, In such cases treatment must be stopped immediater Testosterone may cause a rise in blood pressure and Testosterone Mix Injection 250mg./ml should be used with caution in men with hypertension.epilepsy or Migraine •or a history of these conditions), since androgens may Occasionally induce fluid and sodium retention.
Diabetes melitus-Androgens in general and Testosterone Mix injection 250ms/mi can improve glucose tolerance in diabetic patients.
Anti-coagulant therapy – Androgens in general and Testosterone Mix In ection 250m2/mi can enhance the anti-coagulant actor Sleep apnoes- Caution should be applied when treating men with sleep apnoea. 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 judment and caution should be employed in patients with risk factors such asadiposity or chronic lung diseases.
Adverse events:
If androgen-associated adverse reactions occur, treatment with Testosterone Mix injection 250mg/ml should be discontinued and, upon resolution of complaints, resumed with a lower dose.
Virilisation:
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.
If signs of virilisation develop, the risk/benefit ratio has to be newly assessed with the individual patient.
Misuse in sports:Patients who participate in competitions governed by the World Anti-Doping Agency (WADA) should consult the WADA-code before using this product as Testosterone Mix Injection 250mg/ml can interfere with anti-doping testing. The misuse of androgens to enhance ability in sports carries serious health risks and is to be discouraged.
Excipints:
Testosterone Mix Injection 250mg/ml contains Arachis oil (peanut oil) and should not be taken / applied by patients known to be allergic to peanut. As health risks and is to be discouraged.
250mg/ml.
estosterone Mix injection 250 mg/ml contains 100 mg benzyl alcohol per mi 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.
Female-to-male transsexual supportive therapy:Before initiating Testosterone Mix Injection 250mg/ml 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
FOR THE USE ONLY OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR A LABORATORY
TESTOSTERONE MIX INJECTION 250MG/ML
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 decline in bone density in these patients undergone . oophrectomy,is testerone may noy fully reverse the decline in bone desity in these patients.
Continued surveillance is required to detect osteoporosis in patients who have undergone oophorectomy, as testosterone may not fully reverse the hysterectomy and bilateral oophorectomy.
Pediatric population:
In pre-pubertal children statural growth and sexual development should be monitored since androgens in general and Testosterone Mix injection 250 mg/ml in high dosages may accelerate epiphyse al closure and sexual maturation.
Older People:
There is limited experience on the safety and efficacy of the use of Testosterone Mix Injection 250mg/ml 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 Female-to-male transsexuals:
Different specialist centres have used doses varying from one injection of 1ml every two weeks to one injection of 1ml every four weeks: Method of administration Testosterone Mix Injection 250mg/ml should be administered by deep intramuscular injection.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Due to the nature of Testosterone Mix Injection 250mg/ml side effects cannot be quickly reversed by discontinuing medication. Injectables in general,may cause a local reaction at the injection site.
synonyms and related terms.
Treatment in women:
Treatment with Testosterone Mix Injection 250mg/ml my induce signs of virilisation in women. Symptoms of virilisation may include hoarseness,acne, hirsutism, menstrual irregularity and alopecia.
Pediatric population:
The following undesirable effects have been reported in prepubertal children using androgens: precocious sexual development, an ince frequency of erections, phallic enlargement and premature epiphyseal closure.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product.
Overdose:
The acute toxicity of testosterone is low.If symptoms of chronic overdose occur (e.g. polycythemia, priapism) treatment should be discontinued and after disappearance of the symptoms, be resumed at lower dosage.
PRESENTATION:
Testosterone Mix Injection 250mg/ml is supplied in 1 ml ampoule and further such 10 ampoules packed in a carton along with package-insert and should be stored below 30° C and protected from light.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, If it has expired or is damaged, return it to your pharmacist for disposal.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.