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PREGNYL® (chorionic gonadotropin for injection, USP) 10,000 units/vial Human Gonadotropin
Merck Canada Inc.
16750 route Transcanadienne
Kirkland QC Canada H9H 4M7
The action of human chorionic gonadotropin (hCG) is virtually identical to that of pituitary LH, although hCG appears to have a small degree of FSH activity as well. It stimulates the production of gonadal steroid hormones by stimulating the interstitial cells (Leydig cells) of the testis to produce androgens and the corpus luteum of the ovary to produce progesterone.
Androgen stimulation in the male leads to the development of secondary sex characteristics and may stimulate testicular descent when no anatomical impediment to descent is present.
HCG has no known effect on fat mobilization, appetite or sense of hunger, or body fat distribution. Following IM administration, an increase in serum chorionic gonadotropin concentrations may be observed within 2 hours. Peak concentrations occur within 6 hours and persist for approximately 36 hours. Serum chorionic gonadotropin levels begin to decline at 48 hours reaching undetectable levels after 72 hours. Chorionic gonadotropin is distributed primarily in the testes and ovaries of the male and female respectively, with small amounts possibly distributing into the proximal tubules of the renal cortex.
Blood levels of chorionic gonadotropin decline in a biphasic manner. The initial phase half-life has been reported between 5.6 and 11 hours, whereas the terminal phase half-life has been reported between 23 and 37.2 hours. Following IM administration of therapeutic doses, approximately 10- 12% of the dose is excreted in urine within 24 hours.
Drug Substance:
Chorionic Gonadotropin
Description
Chorionic gonadotropin is a glycoprotein substance, with a molecular weight of approximately 38600 secreted by the placenta and obtained from the urine of pregnant women. It is composed of nonidentical and noncovalently linked α and β subunits. The α subunits of CG is essentially identical to the α subunits of the human pituitary gonadotropins, luteinizing hormone, and follicle stimulation hormone, as well as to the α subunit of human TSH, however, the β subunit of CG differs in amino acid sequence from the other hormones
Chorionic gonadotropin occurs as a white or practically white, amorphous powder and is freely soluble in water.
Composition:
Each vial of Pregnyl® (chorionic gonadotropin for injection, USP) contains: 10,000 USP units of sterile lyophilized human chorionic gonadotropin plus 5 mg of monobasic sodium phosphate monohydrate and 4.4 mg of dibasic sodium phosphate anhydrous (pH may have been adjusted with sodium hydroxide and/or phosphoric acid).
Each vial of Pregnyl® solvent contains: 10mL of Water for Injection, 0.9% of benzyl alcohol, 0.56% sodium chloride and a trace amount of sodium hydroxide and/or hydrochloric acid.
Stability and Storage Recommendations:
Store at 15°C - 30°C. The reconstituted solution is stable for 28 days when refrigerated (2°C - 8°C).
Incompatibilities:
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Reconstituted Solution:
Direction for reconstitution Reconstitute
Pregnyl® 10,000 USP units to the desired concentration by addition of the required amount of the solvent supplied. Remove 1 to 10 mL of the solvent and add to the vial with the lyophilized Pregnyl®, agitate gently until the powder is completely dissolved.
When reconstituted with 10mL of the solvent, the concentration of Chorionic Gonadotropin is 1,000 USP units/mL. The solvent contains 0.9% benzyl alcohol.
AVAILABILITY
Each package contains two vials: one multi-dose vial of Pregnyl® (chorionic gonadotropin for injection, USP) 10,000 USP units plus one vial of 10 mL sterile Pregnyl® solvent.
3 boxes Pregnyl $287.10 CAD (not covered by insurance)
Merck Canada Inc.
16750 route Transcanadienne
Kirkland QC Canada H9H 4M7
The action of human chorionic gonadotropin (hCG) is virtually identical to that of pituitary LH, although hCG appears to have a small degree of FSH activity as well. It stimulates the production of gonadal steroid hormones by stimulating the interstitial cells (Leydig cells) of the testis to produce androgens and the corpus luteum of the ovary to produce progesterone.
Androgen stimulation in the male leads to the development of secondary sex characteristics and may stimulate testicular descent when no anatomical impediment to descent is present.
HCG has no known effect on fat mobilization, appetite or sense of hunger, or body fat distribution. Following IM administration, an increase in serum chorionic gonadotropin concentrations may be observed within 2 hours. Peak concentrations occur within 6 hours and persist for approximately 36 hours. Serum chorionic gonadotropin levels begin to decline at 48 hours reaching undetectable levels after 72 hours. Chorionic gonadotropin is distributed primarily in the testes and ovaries of the male and female respectively, with small amounts possibly distributing into the proximal tubules of the renal cortex.
Blood levels of chorionic gonadotropin decline in a biphasic manner. The initial phase half-life has been reported between 5.6 and 11 hours, whereas the terminal phase half-life has been reported between 23 and 37.2 hours. Following IM administration of therapeutic doses, approximately 10- 12% of the dose is excreted in urine within 24 hours.
Drug Substance:
Chorionic Gonadotropin
Description
Chorionic gonadotropin is a glycoprotein substance, with a molecular weight of approximately 38600 secreted by the placenta and obtained from the urine of pregnant women. It is composed of nonidentical and noncovalently linked α and β subunits. The α subunits of CG is essentially identical to the α subunits of the human pituitary gonadotropins, luteinizing hormone, and follicle stimulation hormone, as well as to the α subunit of human TSH, however, the β subunit of CG differs in amino acid sequence from the other hormones
Chorionic gonadotropin occurs as a white or practically white, amorphous powder and is freely soluble in water.
Composition:
Each vial of Pregnyl® (chorionic gonadotropin for injection, USP) contains: 10,000 USP units of sterile lyophilized human chorionic gonadotropin plus 5 mg of monobasic sodium phosphate monohydrate and 4.4 mg of dibasic sodium phosphate anhydrous (pH may have been adjusted with sodium hydroxide and/or phosphoric acid).
Each vial of Pregnyl® solvent contains: 10mL of Water for Injection, 0.9% of benzyl alcohol, 0.56% sodium chloride and a trace amount of sodium hydroxide and/or hydrochloric acid.
Stability and Storage Recommendations:
Store at 15°C - 30°C. The reconstituted solution is stable for 28 days when refrigerated (2°C - 8°C).
Incompatibilities:
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Reconstituted Solution:
Direction for reconstitution Reconstitute
Pregnyl® 10,000 USP units to the desired concentration by addition of the required amount of the solvent supplied. Remove 1 to 10 mL of the solvent and add to the vial with the lyophilized Pregnyl®, agitate gently until the powder is completely dissolved.
When reconstituted with 10mL of the solvent, the concentration of Chorionic Gonadotropin is 1,000 USP units/mL. The solvent contains 0.9% benzyl alcohol.
AVAILABILITY
Each package contains two vials: one multi-dose vial of Pregnyl® (chorionic gonadotropin for injection, USP) 10,000 USP units plus one vial of 10 mL sterile Pregnyl® solvent.
3 boxes Pregnyl $287.10 CAD (not covered by insurance)
