July 1, 2017
July 1, 2017



Testosterone Propionate 100 MG

100mg/ml Solution for injection

SKU: N/A Category:

Read this entire leaflet carefully before you use this medicine.
Each ml contains:
Testosterone propionate U.S.P 100mg Oil base q.s.Indicationsand usage:
Pronorm 100 ~ is indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone:
A. Primary hypogonadism (congenital oracquired)-testcuiar failure due to cryptorchidism, bilateral torsion, orchitis, vanishing tests syndrome, or orchideclomy.
B Hypogonadotropie hypogonadism (congenital or acquired) Otopathc gonadotropinor LHRH deficiency, or prturtary-hypothalamic injury from tumours, trauma, or radiation.
Pronorm 100*” may be used secondarily in women with advancing in operable metastatic (skeletal) mammary cancer who are 1 to $ years postmenopausal. Pronorml00w has been used for the management of postpartum breast pain and engorgement.
1. Knownhypersensihvitytothedrug.
2. Maleswithcarcinomaofthebreast.
3. Males with known or suspected carcinoma of the prostate gland.
4. Womenwhoareorwhomaybecomepregnant.
5. Patients with senous cardiac, hepatic or renal disease.
Drug interactions:
1. Oxyphenbutazone-Concurrent ad ministration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbgutazone.
2. Insuiin-fndiabetic patients, the metabolic etfectsof androgens may decrease blood glucose and irwulinrequirements.
There have been no reports of acute overdosage with the anabol cs. Precautions:
General: Patents with benign prostatic hypertrophy may develop acute urethral obstruction. Priapism or excessive sexual stimulation may develop. Oligospermiamay occur after prolonged administration or excessive dosage. II any ol these ellects appear, the androgen should be stopped and <1 restarted, a lower dosage should be utilized. Pronormioo,v should not be used interchangeably with testosterone cypionate because of differences in duration ol action.
Pronorm 100″ is not for intravenous use.fnlormaiion for patients: Patients should be instructed to report any of the following nausea, vomiting, changes m skin color, ankle swelling, too frequent or persistent erections ol the penis. Laboratory tests: Hemoglobin and hematocrit levels do delect polycythemia) should be checked penodically in patients receiving long-term androgen administration. Serum cholesterol may increase during androgen therapy. DrugiLaboratory test interferences: Androgens may decrease levels ol ihyroxme-bmding 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 is no dmcai 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 of the tumours m all cases. Genainc patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to suppon this concept is lacking.
Pregnancy: Teratogenic Effects. Pregnancy Category X.
Nursing mother: Pronorm 100’* i$ not recommended for use in nursing mothers.Dosage and adminstration:
Pronorm 100~ is administered by intramuscular injection. It must not be grven intravenously. Intramuscular injections should be given deep in the gluteal muscle. The suggested dosage vanes. Depending on the age. sex. and diagnosis of the individual patent.
Replacement therapy in androgen-deficient males should be in the range of 25-50 mg2or3iimesaweek.
Dosages used in delayed puberty generally are in the lower ranges and are for a limited duration, for example. 4 to 6 months.
Carcinoma of the Breast: In inoperable carcinoma ol Ihe breast Temporaty palliation may be obtained m some cases by therapy with androgens. A dosage of 50-100 mg of PronormlOO^administered intramuscularly 3 Unes weekly is recommended. The above high dosage is likely to have masculinising effects, particular m young women. There may be a disturbing increase in libido, (or which sedation may be helpful. 11 should be remembered that acceleration of tumour growth may be encountered occasionally during androgen therapy, in which case immediate cessation of the hormone is indicated. In some of these cases, the use of estrogen at this point causes regression.
Postpartum Engorgement of the Breasts: A dosage of 25 to 50 mg of Pronorm 100~ daily for 3 to 4 days starting at the time of delivery should be ad equate m most cases.
in patients with breast cancer, androgen therapy may cause hypercalcemia by stimulating osteolysis, tn this case, the drug should be decontmued. Prolonged use ol high doses ol androgens has been associated with the development of peiidsis hepatis and hepatic neoplasms. Including hepatocellular carcinoma hepatic can be a lile-threalening or fatal complication.
Geriatric patients treated with androgens may be at an increased rek for the development of prostatic hypertrophy and prostatic carcinoma.
Edema with or without congestive heart failure may be a serious com pi ication m patents with preexisting cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required.
Gynecomastia frequently develops and occasionally persists in patients being treated tor hypogonadism.
Androgen therapy should be used cautiously m healthy males with delayed puberty. The effect on bone maturation should be monitored by addressing bone age of the wrist and hand every 6 months. In children, androgen treatment may accelerate bone maturation without producing compensatory gam in linear growth. This adverse effect may result m compromised adult stature. The younger the child, the greater the risk ol compromising final mature height.
Do not give Pronorm 100’* to elderty asthenic males who may read adversely to overstimulation by androgens.
How supplied
Pronorm 100’* is supplied m 1 ml ampoule Ampoules should be stored at controlled room temperatures below 30i*C and protected from light. Parenteral drug products should be inspected visually for particulate mailer and discoloration prior to administration, whenever solution and container permit. Warming and shaking the ampoule should redissolve any crystals that may have formed during storage at temperatures lower than recommended. II it has expired oris 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 for use of the product for any other purpose. The product should be used under proper medicalsupervision.
Keep out of the reach and sight of children.
Effect of materials on plants or animals: The product may be harmful to contaminated 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

1 x 10ml, 10 х 1ml

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