Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/939
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
Pregnyl (Kit)
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| dailymed-instance:dosage |
For intramuscular
use only. The dosage regimen employed in any particular case will depend
upon the indication for the use, the age and weight of the patient, and
the physician's preference. The following regimens have been
advocated by various authorities: Prepubertal cryptorchidism not due to
anatomical obstruction. Therapy is usually instituted in children
between the ages of 4 and 9. Selected cases of hypogonadotropic
hypogonadism in males. Induction of ovulation and pregnancy in the
anovulatory, infertile woman in whom the cause of anovulation is
secondary and not due to primary ovarian failure and who has been
appropriately pretreated with human menotropins. (See prescribing
information for menotropins for dosage and administration for that drug
product.) 5,000 to 10,000 USP
Units one day following the last dose of menotropins. (A dosage of
10,000 USP Units is recommended in the labeling for
menotropins.)<br/>Directions for
Reconstitution: Two-vial
package: Withdraw sterile air from lyophilized vial and inject
into diluent vial. Remove 1���10 mL from diluent and add
to lyophilized vial; agitate gently until powder is completely
dissolved in solution. Parenteral
drug products should be inspected visually for particulate
matter and discoloration prior to administration, whenever
solution and container permit. IMPORTANT: USE COMPLETELY AFTER
RECONSTITUTION. RECONSTITUTED SOLUTION IS STABLE FOR 60 DAYS
WHEN REFRIGERATED.
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| dailymed-instance:descripti... |
Human chorionic
gonadotropin (HCG), a polypeptide hormone produced by the human
placenta, is composed of an alpha and a beta sub-unit. The alpha
sub-unit is essentially identical to the alpha sub-units of the human
pituitary gonadotropins, luteinizing hormone (LH) and
follicle-stimulating hormone (FSH), as well as to the alpha sub-unit of
human thyroid-stimulating hormone (TSH). The beta sub-units of these
hormones differ in amino acid sequence. PREGNYL'
(chorionic gonadotropin for injection, USP) is a highly purified
pyrogen-free preparation obtained from the urine of pregnant females. It
is standardized by a biological assay procedure. It is available for
intramuscular injection in multiple dose vials containing 10,000 USP
Units of sterile dried powder with 5 mg monobasic sodium phosphate and
4.4 mg dibasic sodium phosphate. If required, pH is adjusted with sodium
hydroxide and/or phosphoric acid. Each package also contains a 10 mL
vial of solvent containing: water for injection with 0.56% sodium
chloride and 0.9% BENZYL ALCOHOL, WHICH IS NOT FOR USE IN NEWBORNS. If
required, pH is adjusted with sodium hydroxide and/orhydrochloric
acid.
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| dailymed-instance:clinicalP... |
The action of 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. This descent is usually reversible
when HCG is discontinued. During the normal
menstrual cycle, LH participates with FSH in the development and
maturation of the normal ovarian follicle, and the mid-cycle LH surge
triggers ovulation. HCG can substitute for LH in this function. During a
normal pregnancy, HCG secreted by the placenta maintains the corpus
luteum after LH secretion decreases, supporting continued secretion of
estrogen and progesterone and preventing menstruation. HCG HAS NO KNOWN
EFFECT ON FAT MOBILIZATION, APPETITE OR SENSE OF HUNGER, OR BODY FAT
DISTRIBUTION.
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| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
Precocious puberty,
prostatic carcinoma or other androgen-dependent neoplasm, prior allergic
reaction to HCG.
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| dailymed-instance:supply |
Two-vial package
containing: 1-10 mL lyophilized
multiple dose vial containing: 10,000 USP Units chorionic gonadotropin
per vial, NDC 0052-0315-10. 1-10 mL vial of
solvent containing: water for injection with sodium chloride 0.56% and
benzyl alcohol 0.9%, NDC 0052-0325-10. When reconstituted,
each 10 mL vial contains: If required pH
adjusted with sodium hydroxide and/or phosphoric acid.<br/>Storage: Store at
15���30��C (59���86��F).
Reconstituted solution is stable for 60 days when refrigerated. Rx Only Manufactured for Organon USA
Inc. Roseland, NJ 07068 by Baxter
Pharmaceutical Solutions LLC Bloomington, IN 47403 ��2006 Organon USA Inc. 08/06
20
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| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:precautio... |
General: Since
androgens may cause fluid retention, HCG should be used with
caution in patients with cardiac or renal disease, epilepsy,
migraine, or asthma.<br/>Pediatric Use: Induction
of androgen secretion by HCG may induce precocious puberty in
pediatric patients treated for cryptorchidism. Therapy should be
discontinued if signs of precocious puberty occur.<br/>Geriatric Use: Clinical
studies of PREGNYL' (chorionic gonadotropin for
injection, USP) did not include subjects aged 65 and
over.
|
| dailymed-instance:genericMe... |
gonadotropin, chorionic
|
| dailymed-instance:fullName |
Pregnyl (Kit)
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| dailymed-instance:adverseRe... |
Headache,
irritability, restlessness, depression, fatigue, edema, precocious
puberty, gynecomastia, pain at the site of injection.
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| dailymed-instance:warning |
HCG should be used
in conjunction with human menopausal gonadotropins only by physicians
experienced with infertility problems who are familiar with the criteria
for patient selection, contraindications, warnings, precautions, and
adverse reactions described in the package insert for menotropins. The principal
serious adverse reactions during this use are:
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| dailymed-instance:indicatio... |
HCG HAS NOT BEEN
DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF
OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS
BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE
ATTRACTIVE OR���NORMAL���DISTRIBUTION OF FAT, OR THAT
IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH
CALORIE-RESTRICTED DIETS.
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| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Pregnyl
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