Novarel Powder For Solution For Injection 10000U Drug Medication Dosage Information
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Novarel: Powder for solution for injection (10000U)

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What is this Medicine?

HUMAN CHORIONIC GONADOTROPIN (HYOO muhn kor ee ON ik goe NAD oh troe pin) is a hormone. HCG is used for different reasons in men and women. HCG is used in combination with other fertility drugs to increase a woman's chance of pregnancy. In men or adolescent boys, HCG helps the production of testosterone and sperm. HCG is also used in male children with cryptorchidism, a specific birth problem of the testes.

In-Depth Information

Novarel 10,000unit Powder for Injection

NDC: 555661501
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Cryptorchidism, Infertility

Sometimes used for but not FDA approved for the following conditions:
Hypogonadism, Oligospermia, Kaposi's Sarcoma

Storage Information
Store unreconstituted product at 59 to 86 degrees F
Store product reconstituted with BWFI (benzyl alcohol 0.9%) in refrigerator (36-46 degrees F) and use within 30 days
Novarel 10,000unit Powder for Injection

Reported Side Effects for Novarel 10,000unit Powder for Injection

Skin Rash Incidence:
<2.0%*
Severity: MILD
Onset: EARLY
Feeling Sick Incidence:
<2.0%*
Severity: MILD
Onset: EARLY
Vaginal Discharge Incidence:
<2.0%*
Severity: MILD
Onset: DELAYED
Gynecomastia Incidence:
<30.0%*
Severity: MILD
Onset: DELAYED
Emotional Lability Incidence:
<2.0%*
Severity: MILD
Onset: EARLY
Lightheadedness Incidence:
<2.0%*
Severity: MILD
Onset: EARLY
Breakthrough Bleeding Incidence:
<2.0%*
Severity: MILD
Onset: DELAYED
Back Pain Incidence:
<2.0%*
Severity: MILD
Onset: DELAYED
Vaginal Bleeding Incidence:
<2.0%*
Severity: MODERATE
Onset: DELAYED
Loose Stools Incidence:
<2.0%*
Severity: MILD
Onset: EARLY
Tubal Pregnancy Incidence:
<2.0%*
Severity: SEVERE
Onset: DELAYED
Gas Incidence:
<2.0%*
Severity: MILD
Onset: EARLY
Headache Incidence:
<2.0%*
Severity: MILD
Onset: EARLY
Hot Flashes Incidence:
<2.0%*
Severity: MODERATE
Onset: EARLY
Inability To Sleep Incidence:
<2.0%*
Severity: MILD
Onset: EARLY
Breast Pain Incidence:
<2.0%*
Severity: MILD
Onset: DELAYED
Itching Incidence:
<2.0%*
Severity: MILD
Onset: RAPID
Vaginal Infection Incidence:
<2.0%*
Severity: MODERATE
Onset: DELAYED
Ovarian Hyperstimulation Syndrome (OHSS) Incidence:
1.7-9.0%*
Severity: SEVERE
Onset: DELAYED
Vomiting Incidence:
2.5%*
Severity: MILD
Onset: EARLY
Elevated Hepatic Enzymes Incidence:
3.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Enlarged Ovaries Incidence:
3.0%*
Severity: MODERATE
Onset: DELAYED
Stomach Pain Incidence:
3.0-4.2%*
Severity: MILD
Onset: EARLY
Upset Stomach Incidence:
3.4%*
Severity: MILD
Onset: EARLY
Injection Site Reaction Incidence:
14.0-16.2%*
Severity: MILD
Onset: RAPID
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Pregnancy & Lactation Information
FIRST Trimester

Class X - Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant.

SECOND Trimester

Class X - Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant.

THIRD Trimester

Class X - Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant.

Lactation

Caution - Not enough information is available to rule out harm to infants when this drug is taken by nursing mothers.


Learning More About
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