AQUATOR 100
June 30, 2017

ANDROX 400

£10.00£20.00

Testosterone blend 400

400mg/ml Solution for injection

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Description

COMPOSITIONCOMPOSITION
Each ml contains:

  • Testosterone phenylpropionate B.R 100mg Testosterone cypionate U.S.R 10Omg
  • Testosterone isocaproate B.R 100mg
  • Testosterone decanoate B.R lOOmg

Oil base q.s.Read this entire leaflet carefully before you use this medicine.
400mg/ml Solution for injection

Indicationsand usage:
Androx 400’a> is used to replace testosterone in the body to treat various male sexual problems, for exam pie:
– alter castration or a similar piobiem called eunuchoidism
• impotence caused by hormonal disorders
• decreased sex drive
– infertility caused by low sperm count
• bone loss caused by low hormone levels
• when the pituitary gland cannot work as well as it should (hypopituitarism): This can cause decreased sexual ability « males.
Androx 400™ may also be used as supponive therapy for temaie-to-male transsexuals.
Contraindications:
1. Knownhypersensitivftytothednig.
2. Maieswilhcarcinomaolthebreast.
3. Males with known orsuspected carcinoma of the prostate gland.
4. Womenwhoareorwhomaybecomepregnant.
5. Patienis with serious cardiac, hepaticor renal disease.
Drug interactions:
Androgens may increase sensitivity to oral anticoagutahls. Dosage ol the anticoagulant may require reduction m order to maintain satisfactory therapeutichypoprothrombinemia
Concurrent admincstralion of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.
In diabetic patients, the metabolic effects ot androgens may decrease blood glucose and therefore, insulin requirements.
Overdosage:
There have been no reports of acute overdosage wdh the androgens. Precautions:
General: Patients with benign prostatic hypertrophy may develop acute urethral obstruction. Priapism or excessive sexual stimulation may develop. Oligospermia may occur after prolonged administration or excessive dosage. If any of these effects appear, theandrogen should be stopped and if restarted, a lower dosage should be uti hzed. Androx400™ is not not for intravenous use. information for patients: Patients should be instructed to report any of the following nausea, vomiting, changes m skn color, ankle swelling, too frequent or persistent erections olthe penis.
Laboratory tests: Hemoglobin and hematocrit levels (to detect polycythemia) should be checked penodically m patients receiving long-term androgen administration. Serum cholesterol may increase during androgen therapy. DrugiLaboraiory test Interferences: 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, however, and there isnodiracal evidence of thyroid dysfunction.
Carcinogenesis: There are rare reports of hepatocellular carcinoma in patients receiving long term therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression ol me tumours in all cases. Geriatric patients treated with androgens may be at an increased nsk of developing proetatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept s lacking.
Pregnancy: Teratogenic Effects. Pregnancy Category X.
Nursing mother: Androx 400,v is not recommended for use In nursing mothers.Dosage and adminstration:
Androx400″‘ is for intramuscular use only. It should not be given intravenously. Intramuscular injections should be given deep in the gluteal muscle.The suggested dosage (or Androx 400™ vanes depending on the age. sex. and d agnosis of the individual patient.
Adults (male): The dose is chosen by your doctor. Usually one injection of 1 ml every three weeks is given.
Adults (temaie-to-male transsexuals): Doses may vary from one injection of 1ml Androx 400™ every two weeks to one injection of 1ml Androx 400™ every four weeks, depending on the individual.
Elderly: Smaller and less frequent doses may begivento me elderly.
Children: Smaller and less frequent doses may be given tochitdren.
Warnings:
Hypercalcemia may occur in immobilized patients. H this occurs, the drug should be discontinued. Prolonged use of high doses of androgens, (principally the t7-delta alkyl-androgens) has been associated with development ol hepatic adenomas. hepatocellular carcinoma, and peiiosis hepatis- all potentially life-threatening complications
Geriatric patients treated with androgens may be at an increased nsk of developing prostaiic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept >$ lacking. Edema, with or withoul congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal or hepatic disease.
Gynecomastia may develop and occasionally persists m patents being treated for hypogonadism Th>s product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal Gasping Synd rome in premature infants. Androgen therapy should be used cautiously in healthy mates win delayed puberty. The effect on bone maturation should be monitored by assessing bone age ot the wnst and hand every 6 months. In children, androgen treatment may accelerate bone maturation without producing compensatory gam m linear growth.
This adverse effect may resull in compromised adult stature. The younger the child the greater the risk ot compromising final mature height.
How supplied
Androx 400™ is supplied in 1 ml ampoule. Ampoules should be stored at controlled room temperatures below 30’C and protected from light. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever soluiion and container permit. Warming and shaking the ampoule should redissolve any crystals that may have formed durmg storage at temperatures lower than recommended. II it has expwed or is damaged, return it to your pharmacist for disposal.
Abuse in Sports
Abuse of this product in sports is highly discouraged. Thaiger pharma does not take any responsibility lor use ol th*s product lor any other puipose. This product should be used under proper medical supervision.
Keep out of the reach and sight of children.
Effect of materials on plants or animals: The product may be harmful to oonlammated plant and animal life.
Effect of chemicals on aquatic life: This product may be harmful to aquatic plant and animal life in contaminated bodies of water, especially if released in large quantities

Additional information
Amount

1 x 10ml, 10 х 1ml