Ovidrel

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Ovidrel uses


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.

CONTRAINDICATIONS

Precocious puberty, prostatic carcinoma or other androgen-dependent neoplasm, prior allergic reaction to HCG.

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.

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.

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

Clinical studies of Ovidrel ® (chorionic gonadotropin for injection USP) did not include subjects aged 65 and over.

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.

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.

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.

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 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.

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 15–30°C (59–86°F). Reconstituted solution is stable for 60 days when refrigerated.

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of

MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Ovidrel ® manufactured by: Baxter Oncology GmbH, Halle 33790, Germany

Ovidrel Solvent manufactured by: Baxter Pharmaceutical Solutions LLC

Bloomington, IN 47403, USA

For patent information: www.merck.com/product/patent/home.html

Copyright © 1976, 2011 Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc.

All rights reserved.

Revised: 01/2015

uspi-mk8829-pwi-1501-r007

Rx only

Ovidrel pharmaceutical active ingredients containing related brand and generic drugs:


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References

  1. Dailymed."PREGNYL (CHORIOGONADOTROPIN ALFA) KIT [ORGANON USA INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "Choriogonadotropin alfa". https://pubchem.ncbi.nlm.nih.gov/su... (accessed August 28, 2018).
  3. "Choriogonadotropin alfa - DrugBank". http://www.drugbank.ca/drugs/DB0009... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Ovidrel?

Depending on the reaction of the Ovidrel after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Ovidrel not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Ovidrel addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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