Pregnyl
Choriogonadotropin Alfa
A-s Medication Solutions
Human Prescription Drug
NDC 50090-5923Pregnyl also known as Choriogonadotropin Alfa is a human prescription drug labeled by 'A-s Medication Solutions'. National Drug Code (NDC) number for Pregnyl is 50090-5923. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Pregnyl drug includes . The currest status of Pregnyl drug is Active.
Drug Information:
| Drug NDC: | 50090-5923 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Pregnyl |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Choriogonadotropin Alfa |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | A-s Medication Solutions |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | BLA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 20 Oct, 1976 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | BLA017692 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | A-S Medication Solutions
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 896854
896856
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 50090-5923-0 | 1 KIT in 1 KIT (50090-5923-0) * 10 mL in 1 VIAL, MULTI-DOSE * 10 mL in 1 VIAL | 18 Feb, 2022 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Pregnyl choriogonadotropin alfa pregnyl choriogonadotropin alfa choriogonadotropin alfa choriogonadotropin alfa sodium phosphate, monobasic, unspecified form sodium phosphate, dibasic, unspecified form sodium hydroxide phosphoric acid pregnyl solvent water, sodium chloride and benzyl alcohol water sodium chloride benzyl alcohol
Indications and Usage:
Indications and usage 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. prepubertal cryptorchidism not due to anatomical obstruction. in general, hcg is thought to induce testicular descent in situations when descent would have occurred at puberty. hcg thus may help predict whether or not orchiopexy will be needed in the future. although, in some cases, descent following hcg administration is permanent, in most cases, the response is temporary. therapy is usually instituted in children between the ages of 4 and 9. selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males. induction of ovulation and pregnancy in the anovulatory, infe
Read more...rtile 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.
Warnings:
Warnings 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. anaphylaxis has been reported with urinary-derived hcg products. the principal serious adverse reactions during this use are: (1) ovarian hyperstimulation, a syndrome of sudden ovarian enlargement, ascites with or without pain, and/or pleural effusion, (2) rupture of ovarian cysts with resultant hemoperitoneum, (3) multiple births, and (4) arterial thromboembolism.
General Precautions:
General since androgens may cause fluid retention, hcg should be used with caution in patients with cardiac or renal disease, epilepsy, migraine, or asthma.
Dosage and Administration:
Dosage and administration 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. 4000 usp units 3 times weekly for 3 weeks. 5000 usp units every second day for 4 injections. 15 injections for 500 to 1000 usp units over a period of 6 weeks. 500 usp units 3 times weekly for 4 to 6 weeks. if this course of treatment is not successful, another series is begun 1 month later, giving 1000 usp units per injection. selected cases of hypogonadotropic hypogonadism in males. 500 to 1000 usp units 3 times a week for 3 weeks, followed by the same dose twice a week for 3 weeks. 4000 usp units 3 times weekly for 6 to 9 months, following which the dosage may be reduced to
Read more...2000 usp units 3 times weekly for an additional 3 months. 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.) 5000 to 10,000 usp units 1 day following the last dose of menotropins. (a dosage of 10,000 usp units is recommended in the labeling for menotropins.) directions for reconstitution two-vial package: withdraw sterile air from lyophilized vial and inject into diluent vial. remove 1â10 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.
Contraindications:
Contraindications precocious puberty, prostatic carcinoma or other androgen-dependent neoplasm, prior allergic reaction to hcg.
Adverse Reactions:
Adverse reactions headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia, pain at the site of injection. hypersensitivity reactions, both localized and systemic in nature, have been reported.
Pediatric Use:
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.
Geriatric Use:
Geriatric use clinical studies of pregnyl ® (chorionic gonadotropin for injection usp) did not include subjects aged 65 and over.
Description:
Description human chorionic gonadotropin (hcg), a polypeptide hormone produced by the human placenta, is composed of an alpha and a beta subunit. the alpha sub-unit is essentially identical to the alpha subunits of the human pituitary gonadotropins, luteinizing hormone (lh) and follicle-stimulating hormone (fsh), as well as to the alpha subunit of human thyroid-stimulating hormone (tsh). the beta subunits 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/or hydrochloric acid.
Clinical Pharmacology:
Clinical pharmacology 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 preve
Read more...nting menstruation. hcg has no known effect on fat mobilization, appetite or sense of hunger, or body fat distribution.
How Supplied:
How supplied 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: chorionic gonadotropin 10,000 usp units monobasic sodium phosphate 5 mg dibasic sodium phosphate 4.4 mg sodium chloride 0.56% benzyl alcohol 0.9% if required ph adjusted with sodium hydroxide and/or phosphoric acid. storage store at controlled room temperature 15â30°c (59â86°f). reconstituted solution is stable for 60 days when refrigerated.
Package Label Principal Display Panel:
Choriogonadotropin alfa kit label image