Registered Rwanda · Rwanda FDA

FOLISURGE 150

RECOMBINANT-HUMAN FOLLICLE STIMULATING HORMONE

Rwanda FDA-HMP-MA-2326 SOLUTION FOR INJECTION 150 IU/0.24 mL

What it does

Follicle is an active ingredient that is involved in various therapeutic applications related to reproductive health.

Commonly used for: fertility issues, irregular menstrual cycles, ovulation induction

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

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Registration & product details

Registration no.
Rwanda FDA-HMP-MA-2326
Registration date
19/06/2025
Expiry date
18/06/2030
Status
Registered
Active ingredient
RECOMBINANT-HUMAN FOLLICLE STIMULATING HORMONE
Strength
150 IU/0.24 mL
Pack size
GLASS SYRINGE (TYPE I,0.5 mL)
Therapeutic class
-
Manufacturer / MAH
Intas Pharmaceuticals
Country of origin
INDIA
Manufacturer location
Changodar, Gujarat 382213, India

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:02 · updated 2026-09-21 02:30:19

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About follicle

Follicle is an active ingredient that is involved in various therapeutic applications related to reproductive health.

What it treats

  • fertility issues
  • irregular menstrual cycles
  • ovulation induction

How it works

Follicle helps to stimulate the growth and maturation of eggs in the ovaries, which can assist in fertility and menstrual regulation.

Who it's for

This treatment is for women experiencing challenges with fertility or irregular menstrual patterns.

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

About hormone

This medicine contains a hormone that plays a key role in various body functions.

What it treats

  • hormonal imbalances
  • infertility
  • certain menstrual disorders

How it works

The hormone helps to regulate processes in the body, including growth, metabolism, and reproduction.

Who it's for

This medicine is for individuals experiencing hormonal issues or related conditions.

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

About stimulating

This medicine is used to stimulate certain processes in the body.

What it treats

  • fatigue
  • depression
  • attention deficit hyperactivity disorder (ADHD)

How it works

It increases activity in the brain, helping to improve mood, focus, and energy levels.

Who it's for

This medicine is suitable for people who need help with energy and concentration.

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

Clinical monograph: follicle

Follicles are small sac-like structures in the ovaries that contain developing eggs (oocytes) and are crucial for the reproductive process in females. They also play a role in the production of hormones such as estrogen and progesterone. Follicular development is essential for ovulation and fertility, and understanding follicle physiology is important in the context of reproductive health, in vitro fertilization (IVF), and treatment of various gynecological disorders.

Indications

  • Infertility due to ovarian dysfunction
  • Polycystic ovary syndrome (PCOS)
  • Assisted reproductive technologies (ART), including in vitro fertilization (IVF)
  • Hormonal imbalances affecting menstrual cycles

Dosage

Children: Refer to BNF for Children for specific dosing guidelines related to pediatric patients.

Adults: For fertility treatments, specific dosages of FSH or LH should be determined based on individual patient assessment and response, following established protocols.

Mechanism of action

Follicle development is regulated by the hypothalamic-pituitary-gonadal (HPG) axis. Gonadotropin-releasing hormone (GnRH) from the hypothalamus stimulates the anterior pituitary to release follicle-stimulating hormone (FSH) and luteinizing hormone (LH). FSH promotes the growth and maturation of ovarian follicles, while LH triggers ovulation and the formation of the corpus luteum. Estrogen produced by the growing follicles further regulates the menstrual cycle and reproductive functions.

Pharmacodynamics

The pharmacodynamics of follicle activity involves hormonal regulation and interaction. FSH and LH stimulate ovarian follicles, leading to estrogen production, which has various effects on the reproductive system, including the thickening of the endometrium and regulation of the menstrual cycle. The hormonal feedback mechanisms play a critical role in ensuring proper follicular development and function.

Pharmacokinetics

As follicle development is a physiological process rather than a drug, pharmacokinetics is not applicable. However, in a clinical context, the administration of gonadotropins (like FSH and LH) for fertility treatments would involve understanding their absorption, distribution, metabolism, and excretion. Generally, these hormones are administered via injection, with their effects being immediate and closely monitored during fertility treatments.

Adverse effects

  • Ovarian hyperstimulation syndrome
  • Multiple pregnancies
  • Headaches
  • Nausea
  • Vomiting
  • Abdominal discomfort

Precautions

  • Use with caution in patients with a history of ovarian cysts or other ovarian disorders
  • Monitor for signs of ovarian hyperstimulation syndrome
  • Consider potential for multiple gestation

Pregnancy

Follicle-stimulating hormone (FSH) is used in assisted reproductive technology but should not be used in pregnancy unless clearly needed.

Breast-feeding

There is limited data on the excretion of FSH in breast milk; caution is advised.

Storage

Store at 2 to 8 degrees Celsius. Do not freeze. Protect from light.

Formulations

  • Injection solution
  • Lyophilized powder for reconstitution

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: hormone

Hormones are biochemical substances produced by various glands in the body, which regulate physiological processes. They play critical roles in maintaining homeostasis, influencing growth, metabolism, and reproductive functions. Hormone replacement therapy (HRT) is commonly used to alleviate symptoms associated with hormonal deficiencies, particularly in postmenopausal women and individuals with certain endocrine disorders.

Indications

  • Menopausal symptoms (e.g., hot flashes, vaginal dryness)
  • Hypogonadism
  • Thyroid disorders (e.g., hypothyroidism)
  • Adrenal insufficiency
  • Growth hormone deficiency
  • Polycystic ovary syndrome (PCOS)

Dosage

Children: Refer to the BNF for Children for specific paediatric dosing guidelines, as these depend on the type of hormone and the condition being treated.

Adults: Refer to the specific hormone type and formulation for dosing guidance in adults, as dosages may vary significantly based on individual patient needs and specific conditions being treated.

Mechanism of action

Hormones exert their effects through binding to specific receptors on target cells, initiating a cascade of intracellular signaling pathways. This may involve the activation of gene expression, modulation of enzyme activity, or alteration of cell membrane permeability. The specific mechanism varies depending on the type of hormone and its target tissues.

Pharmacodynamics

Hormones have varied effects depending on their class and the target tissues involved. They can influence metabolic pathways, regulate growth and development, and affect mood and cognition. Hormones typically act through either genomic mechanisms, involving changes in gene transcription, or non-genomic pathways, which may involve rapid signaling via second messengers.

Pharmacokinetics

The pharmacokinetics of hormones vary widely based on their chemical structure, route of administration, and formulation. Generally, hormones are absorbed into circulation after administration, with peak plasma concentrations occurring at variable times depending on the specific hormone. They may be metabolized in the liver or other tissues, with elimination typically occurring through renal or biliary excretion. Half-lives can range from minutes to hours, influencing dosing frequency.

Interactions

  • antiepileptics (carbamazepine, eslicarbazepine, fosphenytoin, oxcarbazepine, perampanel, phenobarbital, phenytoin, primidone, rufinamide, topiramate) + hormone replacement therapy: Unknown (decreases effects)
  • bosentan + hormone replacement therapy: Unknown (decreases effects)
  • ritonavir + hormone replacement therapy: Unknown (decreases effects)
  • modafinil + hormone replacement therapy: Unknown (decreases effects)
  • rifamycins + hormone replacement therapy: Unknown (decreases effects)
  • St John's Wort + hormone replacement therapy: Unknown (decreases efficacy)
  • etoricoxib + hormone replacement therapy: Unknown (increases exposure)

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: stimulating

Stimulants are a class of drugs that increase activity in the central nervous system (CNS) and are commonly used to treat conditions such as attention deficit hyperactivity disorder (ADHD), narcolepsy, and certain types of depression. They work by enhancing the levels of neurotransmitters, particularly dopamine and norepinephrine, in the brain, which can improve focus, attention, and energy.

Indications

  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Narcolepsy
  • Obesity (as part of a comprehensive weight management program)
  • Treatment-resistant depression
  • Cognitive enhancement in certain disorders

Dosage

Children: Refer to the BNF for Children for appropriate dosing guidelines based on age and weight.

Adults: Refer to the specific BNF for individual stimulant medications for appropriate dosing guidelines.

Mechanism of action

Stimulants enhance the release of neurotransmitters such as dopamine and norepinephrine in the brain. They inhibit the reuptake of these neurotransmitters, leading to increased synaptic concentrations and prolonged effects. This mechanism is particularly relevant in the treatment of ADHD, where increased dopamine activity in the prefrontal cortex can improve attention and behavior regulation.

Pharmacodynamics

Stimulants generally exert their effects by increasing neurotransmitter availability in the synaptic cleft, leading to enhanced neuronal firing rates. This results in improved cognitive function, mood elevation, and increased physical activity. The specific pharmacodynamic profile can vary between different stimulant medications, with some exhibiting a more pronounced effect on dopamine versus norepinephrine pathways.

Pharmacokinetics

Stimulants are typically well absorbed in the gastrointestinal tract and may have varying half-lives depending on the formulation (immediate vs extended release). They are metabolized primarily in the liver, and their elimination is often through the kidneys. The onset of action can range from minutes to hours, with effects lasting from a few hours to over 12 hours in some extended-release forms.

Pregnancy

The use of stimulating agents during pregnancy should be approached with caution due to potential risks to fetal development. It is essential to weigh the benefits against possible adverse effects.

Breast-feeding

Caution is advised when using stimulating agents while breastfeeding, as they may pass into breast milk and affect the infant.

Storage

Store in a cool, dry place away from direct sunlight. Ensure the container is tightly closed to maintain stability.

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.