boldebol

Boldenone undecyenate

Dosage 250 mg/1ml

Each ml contains: Boldenone undecylenate USP 250mg

Oil Base

Mfg:05/2019

Exp:05/2024

Batch No:GK1538

store in a dark & dry place below 25C keep out of reach of children

 

www.xwellpharma.com

(Boldenone Undecylenate Injection 250mg/ml)

COMPOSITION:

Each ml contains:

Boldenone Undecylenate 250 mg a 0

Oil Base         q.s.

Indications and usage:

Boldebol  is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.

1. Primary hypogonadism (congential or acquiredtesticular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy.)
2. Hypogonadotropic hypogonadism (congenital or acquired)-idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumours, trauma, or radiation:

Contraindications:

1. Known hypersensitivity to the drug
2. Males with carcinoma of the breast.
3. Males with known or suspected carcinoma of the prostate gland.
4. Women who are or who may become pregnant.
5. Patients with serious cardiac. hepatic or renal disease.

Drug Interactions:

Androgens may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may require reduction in order to maintain satisfactory therapeutic hypoprothrombinemia.

Concurrent administration of oxyphenbutazone and andro gens may result in elevated serum levels of oxyph enbutazone.

In diabetic patients, the metabolic effects ofandrogens may decrease blood glucose and therefore. insulin requirements.

Overdosage:

There have been no reports of acute overdosage with the andiogens.

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, the androgen should  be stopped and if restarted, a lower dosage should be utilized. Boldebol  should not be used interchangeably with testosterone propionate because of differences in duration of action. Boldebol  is not for intravenous use.

Information for patients: Patients should be instructed to report any of the following nausea, vomiting. changes in skin color, ankle swelling, too frequent or persistent erections of the penis.

Laboratory tests: Hemoglobin and hematocrit levels (to detect polycythemia) should be checked periodically in patients receiving long-term androgen —administration. Serum cholesterol may increase during androgen therapy. Drug/Laboratory test Interferences: Androgens may decrease levels of thyroxine-binding globulin, resuhng 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 clinical evidence of thyroid dysfunction. .

Carcinogenesis : There are rare reports of hepatocellular carcinoma in patients receiving long term therapy with androgens in high doses. Withdrawal ofthe drugs did not lead to regression of the tumours in all cases.

Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking.

Pregnancy: Teratogenic Effects. Pregnancy’Category X.

Nursing mother: Boldebol  is not recommended for use in nursing mothers.

Dosage and adininstration:

Boldebol  is for intramuscular use only. It should not be given intravenously. Intramuscular injections should be given deep in ‘ the gluteal muscle. The suggested dosage for Boldebol  varies depending on the age, sex, and diagnosis of the individual patient.

Dosage is adjusted according to the patient’s response and the appearance of adverse reactions. Various dosage regimens have been used to induce pubertal changes in hypogonadal males some experts have advocated lower dosages initially, gradually increasing the dose as puberty progresses with or without a decrease to maintenance levels. Other experts emphasize that higher dosages are needed to induce pubertal changes and lower dosages can be used for maintenance after puberty. The chronological and skeletal ages most be taken into consideration, both in determinin g the initial dose and in adjusting the dose.

For replacement in the hypogonadal male, 50-400 mg should be administered every two to four weeks.

Warnings:

Hypercalcernia may occur in immobilized patients. If this occurs, the drug should be discontinued. Prolonged use of high doses of androgens. (principally the 17-delta alkyl-androgens) has been associated with development of hepatic adenomas, hapatocellular carcinoma, and peliosis hepatic-all potentially life-threatening complications.

Geriatric patients heated with andro gens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking. Edema, with or without congestive heart failure, may be a serious complication in patients with pre existing cardiac, renal or hepatic disease.

Gynecomastia may develop and occasionally persists in patients being treated for hypogonadism. This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal Gasping Syndrome in premature infants. Androgen therapy should be used cautiously in healthy males with delayed puberty. The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every 6 months. In children, androgen treatment may accelerate bone maturation without producing compensatory gain in linear growth.

This adverse affect may result in compromised adult stature. The younger the child the greater the risk of compromising final mature height.

How supplied

Boldebol  is supplied in 10 x lml ampoule & 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. If it has expired or is damaged, return it to your pharmacist for disposal.

Abuse in Sports

Abuse of this product in sports is highly discouraged. Xwellpharma does not take any responsibility for use of this product for any other purpose. This product should be used under proper medical supervision.

Keep out of the reach and sight of children.

Manufactured for:

XWELLPHARMA

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FOR THE USE ONLY OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR A LABORATORY.