DOSAGE AND ADMINISTRATION
(Intramuscular Use Only): The dosage regimen employed in any particular case will depend upon the indication for 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
- 4,000 USP Units three times weekly for three weeks.
- 5,000 USP Units every second day for four injections.
- 15 injections of 500 to 1,000 USP Units over a period of six weeks.
- 500 USP Units three times weekly for four to six weeks. If this course of treatment is not successful, another is begun one month later, giving 1,000 USP Units per injection.
Selected cases of hypogonadotropic hypogonadism in males
- 500 to 1,000 USP Units three times a week for three weeks, followed by the same dose twice a week for three weeks.
- 4,000 USP Units three times weekly for six to nine months, following which the dosage may be reduced to 2,000 USP Units three times weekly for an additional three months.
Table 1. Final Concentration after Reconstitution
|Reconstitution volume||10,000 IU Vial Concentration||5,000 IU Vial Concentration||Administration|
|1 mL||10,000 IU/mL||5,000 IU/mL||Administer entire dose at once|
|10 mL||1,000 IU/mL||500 IU/mL||Multiple dose administration, refrigerate between doses|
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).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Disposing Of Needles And Syringes
To safely dispose of medical sharps, place used needles and syringes in a closeable, puncture-resistant container, such as a red biohazard sharps container. Sharps containers should then be taken to a collection center for proper disposal. Ask your physician or pharmacist or reference our website for more information about safely disposing used sharps.
In some states, it is illegal to throw away medical sharps in household garbage, recycling, and compost bins. Needles and other sharps must be placed in an approved sharps container and disposed of at an approved drop-off site.
Chorionic Gonadotropin for Injection, USP, is available as individually packaged vials containing 5,000 or 10,000 USP Units per vial.
Each vial of Novarel® is accompanied by a vial of sterile diluent containing 10 mL of Bacteriostatic Water for Injection, USP containing 0.9% benzyl alcohol.
Novarel® is available in the following presentations:
- NDC 55566-1501-1: 10,000 USP units of Chorionic Gonadotropin injection in 1 vial with blue cap and 1 vial of diluent
- NDC 55566-1502-1: 5,000 USP units of Chorionic Gonadotropin injection in 1 vial with aqua cap and 1 vial of diluent
Store dry product at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (between 59° and 86°F) [See USP Controlled Room Temperature].
REFRIGERATE RECONSTITUTED PRODUCT AT 2° to 8°C (36° to 46°F) AND USE WITHIN 30 DAYS.
Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054. Revised: May 2018