DESCRIPTION

BOLDAVIS 250 is an oily solution of boldenone undecylenate for IM injection.

BOLDAVIS 250 is designed to release boldenone slowly from the injection site. Boldenone

serum levels will remain elevated for 5 to 8 days after administration. Boldenone is an

anabolic steroid possessing anabolic properties with moderate androgenic activity.

Anabolic and androgenic agents are widely used in the treatment of catabolic processes

where accelerated strength and muscular development are indicated.

CLINICAL PHARMACOLOGY

Anabolic steroids are synthetic derivatives of testosterone. Certain clinical effects and

adverse reactions demonstrate the androgenic properties of these drugs. Complete

dissociation of anabolic and androgenic effects has not been achieved.

The actions of anabolic steroids are thus similar to those of male sex hormones. Anabolic

steroids suppress

the gonadotropic functions of the pituitary and may exert a direct effect upon the testes.

During exogenous administration of anabolic androgens, endogenous testosterone release

is inhibited through inhibition of pituitary luteinizing hormone (LH).

At large doses, spermatogenesis may be suppressed through feedback inhibition of pituitary

follicle-stimulating hormone (FSH).

Pharmacological studies involving laboratory animals have demonstrated boldenone to

have potent anabolic properties as well as moderate androgenic activity. In clinical trials

boldenone demonstrated a moderate to strong anabolic effect, improved appetite, increased

vigor, and improved musculature and strength.

INDICATIONS

BOLDAVIS 250 is indicated as an alternate or adjunctive therapy in patients for the promotion

of weight gain following

weight loss and/or muscular atrophy associated with extensive surgery, chronic infections,

long term hospitalization, or severe trauma.

For increased RBC in severe anemic patients where first-line therapy is contraindicated.

For promotion of increased appetite in patients with appetite limited intake.

Boldenone should be considered only as an adjunctive therapy together with other

androgenic medications.

DOSAGE AND ADMINISTRATION

Dosage has not been established. Use only pursuant to instructions of a qualified physician.

ADVERSE REACTIONS

Male: Gynecomastia, excessive frequency and duration of penile erections, oligospermia.

Skin and Appendages: Hirsutism, male pattern baldness and acne, gynecomastia.

Fluid/electrolyte Disturbances: Retention of sodium, chloride, water, potassium, calcium,

and inorganic phosphates.

Gastrointestinal: Nausea, cholestatic jaundice, alterations in liver function tests; rarely,

hepatocellular neoplasms,

peliosis hepatitis, hepatic adenomas, and cholestatic hepatitis.

Hematologic: Suppression of clotting factors II, V, VII, & X; bleeding in patients on anticoagulant therapy.

Nervous System: Increased or decreased libido, headache, anxiety, depression, and

generalized paresthesia.

Other: Serum lipid changes, hypercalcaemia, hypertension, oedema, priapism, and

potentiation of sleep apnea.

CONTRAINDICATIONS

Patients with known hypersensitivity to any ingredients in this product.

Patients with known or suspected carcinomas of the breast, testis, or prostate.

Patients with severe heart disease, liver disease, or kidney disease or with a history of

epilepsy.

Products containing androgens should not be used in women as they may cause virilization

and fetal harm.

PRECAUTIONS

Because androgens may alter serum cholesterol concentration, caution should be used

when administering these drugs to patients with a history of myocardial infarction or

coronary artery disease.

Patients on oral anticoagulant therapy require close monitoring especially when androgens

are started or stopped.

Diabetics: androgens may alter the metabolism of oral hypoglycemic agents or may change

insulin sensitivity in patients with diabetes mellitus which may require adjustment of dosage

of insulin and other hypoglycemic drugs.

PATIENT MONITORING

Serum Cholesterol, HDL, LDL, TG. Hemoglobin and Hematocrit, Hepatic function tests –

AST/ALT Prostatic specific antigen – PSA, Testosterone: total, free, and bioavailable.

Dihydrotestosterone & Estradiol.

Male patients over 40 should undergo a digital rectal examination and evaluate PSA prior to

androgen use.

Periodic evaluations of the prostate should continue while on androgen therapy, especially in

patients with difficulty in urination or with changes in voiding habits.

WARNING

No human trials have been conducted. In the absence of data on the effect of this drug on

human subjects, such use should be on a research basis only under the supervision of a

qualified physician.

PRESENTATION

BOLDAVIS 250(250mg/ml) -10 ampules of 1ml each.