International reference: 6 US FDA recalls for this ingredient

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. (gonadotropin)

Lack of Sterility Assurance. (gonadotropin)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance (gonadotropin)

CGMP deviations: Lack of potency testing. (gonadotropin)

Lack of Assurance of Sterility; all sterile human compounded drugs within expiry (gonadotropin)

Lack of Assurance of Sterility (gonadotropin)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Zambia.

Registered Zambia · ZAMRA

Hucog 5000 HP Injection

Human Chrorionic Gonadotropin BP 5000 IU

ZAMRA-HM-25-71 Lyophilised powder for injection 5000 IU

What it does

Chorionic is a medication used in certain medical conditions related to pregnancy and hormonal balance.

Commonly used for: supporting early pregnancy, treating hormonal imbalances

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

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Sourcing - Kenya only

Registration & product details

Registration no.
ZAMRA-HM-25-71
Registration date
2025-03-20
Expiry date
2030-03-19
Status
Registered/Compliant
Active ingredient
Human Chrorionic Gonadotropin BP 5000 IU
Strength
5000 IU
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Bharat Serums And Vaccines
Country of origin
India
Manufacturer location
3RD Floor, Liberty Tower, Plot No. K-10, behind Reliable Plaza, Kalwa Industrial Estate, Gavate Wadi, MIDC, Airoli, Navi Mumbai, Maharashtra 400708, India

Source: Zambia Medicines Regulatory Authority · fetched 2026-03-12 00:01:07 · updated 2026-09-17 03:32:32

Disclaimer: This information is sourced from Zambia Medicines Regulatory Authority (Zambia). Always consult a qualified healthcare professional before using any medication.

About chrorionic

Chorionic is a medication used in certain medical conditions related to pregnancy and hormonal balance.

What it treats

  • supporting early pregnancy
  • treating hormonal imbalances

How it works

Chorionic works by providing hormones that are essential for maintaining pregnancy and regulating reproductive functions.

Who it's for

This medication is typically for women who are pregnant or are experiencing hormonal issues.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About gonadotropin

Gonadotropin is a hormone used to help with reproductive issues.

What it treats

  • infertility treatment
  • stimulating ovulation
  • supporting pregnancy

How it works

Gonadotropin helps regulate hormones that are essential for reproduction.

Who it's for

This medication is for individuals experiencing fertility problems.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About human

Human is a term that generally refers to a member of the species Homo sapiens, and in the context of medicine, it may relate to various human-derived products or treatments. However, there are no specific drug class, interactions, or cautions provided for this entry.

How it works

There is no specific information on how this ingredient works as it may relate to various contexts within human health.

Who it's for

Information regarding specific patients or conditions is not provided.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: chrorionic

Chorionic gonadotropin, also known as human chorionic gonadotropin (hCG), is a glycoprotein hormone produced by the placenta during pregnancy. It plays a crucial role in maintaining the corpus luteum and promoting the production of progesterone, which is essential for the maintenance of pregnancy. hCG is also used in various medical settings, including fertility treatments and in the management of certain medical conditions such as cryptorchidism and hypogonadism.

Indications

  • Fertility treatments in women, such as induction of ovulation
  • Support of early pregnancy in women with luteal phase defects
  • Treatment of hypogonadism in males
  • Management of cryptorchidism in boys
  • Assisted reproductive technologies

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations in pediatric patients.

Adults: Refer to the BNF for specific dosing guidelines based on the indication and clinical scenario.

Mechanism of action

Chorionic gonadotropin exerts its effects primarily by binding to the luteinizing hormone (LH) receptor, which is present in the ovaries and testes. This binding stimulates the production of sex steroids, including testosterone in males and progesterone and estrogen in females, leading to various physiological effects related to reproduction and pregnancy maintenance.

Pharmacodynamics

Following administration, hCG acts similarly to LH in the body. In females, it stimulates ovulation and the maintenance of the corpus luteum, thereby enhancing progesterone production. In males, hCG stimulates Leydig cells in the testes to produce testosterone. The pharmacodynamic effects of hCG can lead to increased fertility and successful pregnancy outcomes when used in appropriate clinical contexts.

Pharmacokinetics

Chorionic gonadotropin has a half-life of approximately 24 to 36 hours. It is usually administered via intramuscular or subcutaneous injection, leading to peak serum levels within 24 to 48 hours post-injection. The elimination of hCG occurs through renal clearance, with a significant amount being excreted unchanged in the urine. The pharmacokinetics can vary based on the route of administration and the specific formulation used.

Contra-indications

  • Hypersensitivity to the active substance or to any of the excipients
  • Undiagnosed vaginal bleeding
  • Ovarian cysts
  • Pregnancy (in certain formulations)

Adverse effects

  • Headaches
  • Nausea
  • Vomiting
  • Mood swings
  • Injection site reactions
  • Ovarian hyperstimulation syndrome

Interactions

  • May interact with other hormonal medications
  • Caution when used with anticoagulants

Precautions

  • Monitor for signs of ovarian hyperstimulation syndrome
  • Use with caution in patients with a history of hormone-sensitive conditions

Pregnancy

Chorionic is used in certain pregnancy-related treatments but should be administered under strict medical supervision.

Breast-feeding

Consult a healthcare provider before use, as safety during breastfeeding is not established.

Storage

Store in a cool, dry place away from light. Keep out of reach of children.

Formulations

  • Injectable solution

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: gonadotropin

Gonadotropins are a class of hormones that play a crucial role in regulating reproductive processes. They include follicle-stimulating hormone (FSH), luteinizing hormone (LH), and human chorionic gonadotropin (hCG). These hormones are secreted by the anterior pituitary gland and are essential for the development and function of the gonads (ovaries and testes). Gonadotropins are used therapeutically in various conditions related to fertility and reproductive health.

Indications

  • Infertility treatment in women
  • Ovulation induction in anovulatory women
  • Assisted reproductive technologies (e.g., in vitro fertilization)
  • Hypogonadism in men
  • Testicular function restoration
  • Support of luteal phase in assisted reproduction

Dosage

Children: Refer to specific product guidelines for dosing, as it varies by indication and formulation.

Adults: Refer to specific product guidelines for dosing, as it varies by indication and formulation.

Mechanism of action

Gonadotropins exert their effects by binding to specific receptors on target cells in the gonads. FSH binds to FSH receptors, stimulating ovarian follicle development in females and spermatogenesis in males. LH acts on luteinizing hormone receptors, triggering ovulation in females and testosterone production in males. hCG mimics LH, influencing ovarian and testicular function. These actions lead to the regulation of gametogenesis and steroidogenesis.

Pharmacodynamics

The pharmacodynamic effects of gonadotropins include the stimulation of gonadal hormone production and maturation of germ cells. FSH promotes the growth of ovarian follicles and the synthesis of estrogen, while LH is crucial for ovulation and progesterone production. In males, FSH is involved in spermatogenesis, while LH stimulates testosterone secretion, which is vital for male reproductive health.

Pharmacokinetics

Gonadotropins are generally administered via injection due to their protein nature, which prevents oral bioavailability. They have variable half-lives, depending on the specific gonadotropin. For example, hCG has a longer half-life compared to FSH and LH, allowing for less frequent dosing in therapeutic settings. The elimination of gonadotropins occurs mainly through the kidneys, with some degradation in the liver.

Contra-indications

  • Hypersensitivity to gonadotropins or any of their excipients
  • Pregnancy
  • Ovarian cysts or enlargement not due to polycystic ovary syndrome
  • Hormone-dependent tumors

Adverse effects

  • Ovarian hyperstimulation syndrome (OHSS)
  • Multiple pregnancies
  • Headache
  • Nausea
  • Abdominal discomfort
  • Injection site reactions
  • Mood swings

Interactions

  • Corticosteroids may enhance the effects of gonadotropins
  • Other hormonal therapies may interact and affect efficacy

Precautions

  • Monitor for signs of OHSS, especially in cases of multiple follicles
  • Assess ovarian function prior to treatment
  • Use with caution in patients with a history of thromboembolic disorders

Pregnancy

Gonadotropins are contraindicated in pregnancy due to risk of adverse effects on the fetus.

Breast-feeding

Limited data available; caution is advised as it is not known if gonadotropins are excreted in breast milk.

Storage

Store in a refrigerator (2 to 8 degrees Celsius). Do not freeze. Protect from light.

Formulations

  • Human chorionic gonadotropin (hCG)
  • Luteinizing hormone (LH)
  • Follicle-stimulating hormone (FSH)

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: human

Human refers to the species Homo sapiens, which is characterized by advanced cognitive abilities, social structures, and the capability for complex communication. The term may also refer to human-derived biological products, such as blood, tissues, or organs used in medical treatments and research.

Dosage

Children: Dosage for human-derived biological products in pediatrics should be determined based on specific product guidelines and the clinical context.

Adults: Dosage for human-derived biological products varies widely. Refer to specific product information for appropriate dosing.

Mechanism of action

Human physiology is governed by complex biological systems involving various cellular and molecular pathways. The mechanisms of action for human-derived biological products vary widely depending on the specific context, including immune response, hormonal regulation, and metabolic processes.

Pharmacodynamics

Pharmacodynamics in humans involves the interaction of drugs with biological systems, resulting in therapeutic effects. This includes receptor binding, signal transduction, and physiological responses. The effects are influenced by genetic factors, existing health conditions, and concurrent medications.

Pharmacokinetics

Pharmacokinetics in humans involves the absorption, distribution, metabolism, and excretion (ADME) of substances. Factors such as age, sex, body weight, and organ function can significantly influence these processes. Drug absorption may occur via oral, intravenous, or other routes, while distribution depends on blood flow and tissue permeability. Metabolism typically occurs in the liver, and excretion primarily takes place through the kidneys.

Pregnancy

There is no specific information available; consult local guidelines.

Breast-feeding

There is no specific information available; consult local guidelines.

Storage

Store in a cool, dry place away from direct sunlight.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.