Ország: Kanada
Nyelv: angol
Forrás: Health Canada
CHORIONIC GONADOTROPIN
ORGANON CANADA INC.
G03GA01
CHORIONIC GONADOTROPHIN
10000UNIT
KIT
CHORIONIC GONADOTROPIN 10000UNIT
INTRAMUSCULAR
10ML
Prescription
GONADOTROPINS AND ANTIGONADOTROPINS
Active ingredient group (AIG) number: 0106481003; AHFS:
APPROVED
2009-02-18
PACKAGE INSERT PREGNYL ® (CHORIONIC GONADOTROPIN FOR INJECTION, USP) 10,000 UNITS/VIAL HUMAN GONADOTROPIN Date of Initial Approval: October 13, 2010 ORGANON CANADA INC. 16766 route Transcanadienne Kirkland QC Canada H9H 4M7 Date of Revision: March 30, 2021 Submission Control No: 249487 ® N.V. Organon. Used under license. 2 PACKAGE INSERT PREGNYL ® (CHORIONIC GONADOTROPIN FOR INJECTION, USP) 10,000 UNITS/VIAL THERAPEUTIC CLASSIFICATION HUMAN GONADOTROPIN ACTION 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 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 possible 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 3 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. INDICATION Pregnyl ® (chorionic gonadotropin for injection, USP) is indica Olvassa el a teljes dokumentumot