International reference: 6 US FDA recalls for this ingredient

Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. (activity)

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. (activity)

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. (activity)

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. (activity)

Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. (activity)

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. (activity)

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

Valid Ghana · FDA Ghana

MIMORAL TABLET (Each tablet contains Trypsin Chymotrypsin (6:1) equivalent to 50,000 USP units of proteolytic enzyme activity 50000iu)

Trypsin - Chymotrypsin (6:1) equivalent to 50,000 USP units of proteolytic enzyme activity

FDA/SD.243-050859 Trypsin - Chymotrypsin (6:1) equivalent to 50,000 USP units of proteolytic enzyme activity 50000iu blood and blood forming organs INN generic

What it does

Activity is a medication used to help manage certain health conditions.

Commonly used for: specific health condition 1, specific health condition 2

Read more in plain English ↓

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

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Sourcing - Kenya only

Registration & product details

Registration no.
FDA/SD.243-050859
Registration date
2024-05-29
Expiry date
2029-05-01
Status
Valid
Active ingredient
Trypsin - Chymotrypsin (6:1) equivalent to 50,000 USP units of proteolytic enzyme activity
Strength
50000iu
Pack size
-
Therapeutic class
-
ATC class (WHO)
B06AA - Enzymes
RxNorm RxCUI
2530
Manufacturer / MAH
Mvc Pharmaceuticals
Country of origin
India
Manufacturer location
Plot 911-912, Phase 3, GIDC, Phase 3, GIDC, Vapi, Gujarat 396195, India

Source: Food and Drugs Authority · fetched 2026-04-18 08:37:30 · updated 2026-10-27 04:00:07

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

About activity

Activity is a medication used to help manage certain health conditions.

What it treats

  • specific health condition 1
  • specific health condition 2

How it works

Activity works by influencing certain processes in the body to help improve health.

Who it's for

Activity is suitable for patients with specific health conditions as advised by their healthcare provider.

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

About chymotrypsin

Chymotrypsin is an enzyme that helps break down proteins in the body. It is used to aid digestion and reduce swelling.

What it treats

  • digestive issues
  • post-surgery swelling

How it works

Chymotrypsin helps to digest proteins by breaking them down into smaller pieces, making it easier for the body to absorb nutrients.

Who it's for

Chymotrypsin is suitable for individuals with digestive problems or those recovering from surgery.

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

About enzyme

Enzymes are proteins that help speed up chemical reactions in the body. They play important roles in digestion and other bodily functions.

What it treats

  • digestive problems
  • enzyme deficiency disorders

How it works

Enzymes break down food into smaller parts, making it easier for the body to absorb nutrients.

Who it's for

People with digestive issues or those who lack certain enzymes needed for digestion.

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

About proteolytic

Proteolytic enzymes help break down proteins in the body, which can aid digestion and support various bodily functions.

What it treats

  • digestive issues
  • protein digestion disorders

How it works

Proteolytic enzymes work by breaking down protein molecules into smaller parts, making it easier for the body to absorb nutrients.

Who it's for

This treatment is generally for individuals with digestive problems, particularly those who have difficulty breaking down proteins.

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

About trypsin

Trypsin is an enzyme that helps break down proteins in the body, aiding in digestion.

What it treats

  • digestive issues
  • protein digestion support

How it works

Trypsin works by breaking down proteins into smaller pieces, making it easier for your body to absorb nutrients.

Who it's for

Trypsin is for people who have trouble digesting proteins due to certain health conditions.

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

About units

Units are used to measure the amount of a substance, often in relation to medication doses.

How it works

Units help in quantifying and administering medications accurately.

Who it's for

Anyone needing to understand medication dosages.

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

Clinical monograph: activity

Activity refers to the pharmacological effects of a drug or substance, particularly its capacity to produce a desired biological response. This can encompass a wide range of effects depending on the drug's mechanism of action and the biological systems it interacts with. Activity can be influenced by various factors including the dose, route of administration, and individual patient characteristics.

Indications

  • Pain management
  • Infection control
  • Inflammation reduction
  • Chronic disease management
  • Anxiety and depression treatment
  • Management of acute conditions

Dosage

Children: Refer to the specific drug dosing guidelines for children, as pediatric dosing is often based on weight or age and varies by medication.

Adults: Refer to the specific drug dosing guidelines for adults based on the condition being treated, as dosing will vary widely.

Mechanism of action

The mechanism of action of a drug defines how it exerts its effects on the body at the molecular level. This could involve binding to specific receptors, inhibiting enzymes, disrupting cellular processes, or modulating neurotransmitter levels. These interactions ultimately lead to changes in physiological functions.

Pharmacodynamics

Pharmacodynamics refers to the study of the effects of a drug on biological systems, including the relationship between drug concentration and effect. Factors that influence pharmacodynamics include receptor affinity, intrinsic activity, and the presence of other drugs or substances that may enhance or inhibit the drug's action. Understanding pharmacodynamics is crucial for optimizing therapeutic effects while minimizing adverse reactions.

Pharmacokinetics

Pharmacokinetics is the study of how the body absorbs, distributes, metabolizes, and excretes a drug. Key processes include absorption (how the drug enters the bloodstream), distribution (how it spreads through the body), metabolism (how it is chemically altered), and excretion (how it is removed from the body). These processes can vary based on the drug's formulation, the route of administration, and individual patient factors such as age, weight, and organ function.

Pregnancy

Safety in pregnancy is not established.

Breast-feeding

Safety during breastfeeding is not established.

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.

Clinical monograph: chymotrypsin

Chymotrypsin is a serine protease enzyme that plays a crucial role in the digestive process by catalyzing the hydrolysis of peptide bonds in proteins. It is derived from the pancreas and is activated from its precursor form, chymotrypsinogen, in the presence of trypsin. Chymotrypsin is commonly used in clinical settings for its anti-inflammatory properties and as a digestive aid. It is often employed in the management of conditions requiring protein breakdown, such as pancreatitis and certain surgical procedures.

Indications

  • Pancreatitis
  • Surgical procedures requiring protein digestion
  • Post-operative recovery
  • Inflammatory conditions

Dosage

Children: Refer to established clinical guidelines for dosing recommendations.

Adults: Refer to established clinical guidelines for dosing recommendations.

Mechanism of action

Chymotrypsin functions by cleaving peptide bonds at the carboxyl side of aromatic amino acids, such as tryptophan, phenylalanine, and tyrosine. This proteolytic activity reduces the size of protein molecules, facilitating their absorption and utilization in the body. The enzyme's action is highly specific and efficient, contributing to the overall digestive process.

Pharmacodynamics

Chymotrypsin exhibits its effects primarily through its enzymatic activity, enhancing the digestion of dietary proteins and facilitating nutrient absorption. Additionally, it may exert anti-inflammatory effects by modulating the immune response and reducing edema in tissues. Its activity is influenced by factors such as pH, temperature, and the presence of other ions or molecules in the digestive system.

Pharmacokinetics

Chymotrypsin is administered orally or via injection, where it is absorbed through the gastrointestinal tract or directly into the bloodstream. Once in circulation, it is distributed to tissues where it exerts its enzymatic effects. The enzyme is subject to degradation by proteolytic enzymes in the body, and its activity can be influenced by the physiological state of the patient, including factors such as age, health status, and concurrent medications. The half-life of chymotrypsin varies based on the route of administration and individual patient factors.

Contra-indications

  • Hypersensitivity to chymotrypsin or any component of the formulation
  • Active bleeding disorders
  • History of gastrointestinal ulcers
  • Severe renal impairment

Adverse effects

  • Allergic reactions including rash, itching, and anaphylaxis
  • Gastrointestinal disturbances such as nausea, vomiting, and diarrhea
  • Local irritation at the injection site
  • Increased risk of bleeding due to its proteolytic activity

Interactions

  • May enhance the effects of anticoagulants due to increased proteolytic activity
  • Use with caution in patients taking other medications that affect hemostasis
  • No significant drug-drug interactions are well documented

Precautions

  • Use with caution in patients with a history of allergic reactions
  • Monitor for signs of bleeding in patients with compromised hemostasis
  • Assess renal function before administration in patients with renal impairment

Pregnancy

Chymotrypsin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as studies on its safety in pregnant women are lacking.

Breast-feeding

It is not known whether chymotrypsin is excreted in human milk. Caution should be exercised when administering to nursing women.

Storage

Store at room temperature, away from light and moisture. Keep out of reach of children.

Formulations

  • Chymotrypsin injection solution
  • Chymotrypsin enteric-coated tablets

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: enzyme

Enzymes are biological catalysts that accelerate chemical reactions in the body. They are crucial for various metabolic processes, including digestion, energy production, and the synthesis of biomolecules. Enzymes are proteins that are highly specific to their substrates and can be influenced by factors such as temperature and pH.

Indications

  • Enzyme replacement therapy
  • Digestive disorders
  • Metabolic disorders
  • Cancer treatment
  • Antibiotic treatment enhancement

Dosage

Children: Refer to specific guidelines for enzyme replacement therapies or digestive aids, as dosing varies by enzyme type and indication.

Adults: Refer to specific guidelines for enzyme replacement therapies or digestive aids, as dosing varies by enzyme type and indication.

Mechanism of action

Enzymes function by lowering the activation energy required for a chemical reaction, thus increasing the rate of the reaction. They bind to specific substrates at their active sites, forming enzyme-substrate complexes, which then undergo a transformation to produce the desired products while regenerating the enzyme for subsequent reactions.

Pharmacodynamics

The pharmacodynamic properties of enzymes are characterized by their catalytic efficiency, often described by parameters such as Km (Michaelis constant) and Vmax (maximum reaction velocity). Enzymes can be regulated through various mechanisms, including allosteric regulation, covalent modification, and feedback inhibition, allowing for precise control over metabolic pathways.

Pharmacokinetics

The pharmacokinetics of enzymes involve their absorption, distribution, metabolism, and excretion. Enzymes administered therapeutically may be subject to degradation by proteolytic enzymes in the gastrointestinal tract, influencing their bioavailability. Their distribution may vary based on the enzyme's size and solubility, and they can undergo modifications that affect their half-life and activity in the body.

Pregnancy

The safety of enzyme therapy during pregnancy varies depending on the specific enzyme. Consultation with a healthcare provider is recommended.

Breast-feeding

The transfer of enzymes into breast milk is variable. Caution is advised when administering enzyme therapy to breastfeeding mothers.

Storage

Store in a cool, dry place, away from direct sunlight and moisture. Specific storage conditions may vary based on the type of enzyme.

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: proteolytic

Proteolytic enzymes, also known as proteases, are a class of enzymes that catalyze the breakdown of proteins into smaller peptides or amino acids through hydrolysis of peptide bonds. They play essential roles in various biological processes including digestion, cell signaling, and immune responses. Proteolytic enzymes are found in many organisms, including humans, and are used therapeutically in conditions requiring enhanced protein digestion or modulation of inflammatory responses.

Indications

  • Pancreatic insufficiency
  • Digestive disorders
  • Inflammatory conditions
  • Post-surgical recovery
  • Wound healing
  • Certain cancers

Dosage

Children: Refer to specific product guidelines for dosage in children, considering age, weight, and clinical condition.

Adults: Refer to specific product guidelines for dosing, as proteolytic enzyme doses can vary widely based on the formulation and clinical indication.

Mechanism of action

Proteolytic enzymes function by cleaving peptide bonds in proteins, which leads to the degradation of proteins into smaller peptides or free amino acids. This process is vital for digestion, and these enzymes can also modulate physiological processes such as inflammation and immune responses through the breakdown of signaling proteins.

Pharmacodynamics

The pharmacodynamic effects of proteolytic enzymes depend on their specific types and targets. Generally, they facilitate the digestion of dietary proteins, enhance the absorption of amino acids, and can influence inflammatory pathways by modulating cytokine activity. The activity of proteolytic enzymes can be influenced by factors such as substrate specificity, pH, and the presence of inhibitors.

Pharmacokinetics

The pharmacokinetics of proteolytic enzymes can vary considerably based on their source and formulation. Typically, these enzymes are administered orally and may be subject to inactivation in the gastrointestinal tract. Enteric-coated formulations are often used to protect enzymes from gastric acid. Following absorption, the enzymes may exert systemic effects, depending on their ability to reach target tissues. The half-life and elimination routes are also variable and need to be assessed for each specific enzyme.

Adverse effects

  • Allergic reactions
  • Gastrointestinal disturbances
  • Nausea
  • Diarrhea
  • Abdominal pain

Precautions

  • Use cautiously in patients with known allergies to proteolytic enzymes or their components
  • Monitor for gastrointestinal side effects during treatment
  • Consider potential interactions with other medications that affect digestion

Pregnancy

Safety during pregnancy has not been established. Use only if clearly needed and prescribed by a healthcare professional.

Breast-feeding

Caution is advised as it is unknown if proteolytic enzymes are excreted in breast milk.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Tablets
  • Capsules
  • Powder for 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: trypsin

Trypsin is a serine protease enzyme produced in the pancreas that plays a crucial role in the digestion of proteins. It is secreted as an inactive precursor, trypsinogen, which is activated in the small intestine. Trypsin hydrolyzes peptide bonds, particularly those involving the amino acids lysine and arginine, facilitating the breakdown of dietary proteins into smaller peptides and amino acids for absorption.

Indications

  • Pancreatic insufficiency
  • Malabsorption syndromes
  • Cystic fibrosis
  • Chronic pancreatitis

Dosage

Children: Refer to the BNF for Children for appropriate dosing information tailored to paediatric patients.

Adults: Refer to the prescribing information or BNF for specific dosing guidelines based on the condition being treated and the formulation used.

Mechanism of action

Trypsin acts by cleaving peptide bonds in proteins, particularly at the carboxyl side of lysine and arginine residues. This enzymatic activity is essential for protein digestion, leading to the conversion of proteins into smaller peptides and free amino acids, which can be readily absorbed by the intestinal mucosa. The activation of trypsinogen to trypsin is catalyzed by the enzyme enteropeptidase, which is secreted by the intestinal mucosa.

Pharmacodynamics

The pharmacodynamic effects of trypsin are primarily related to its role in protein digestion. It aids in the breakdown of complex protein structures into smaller peptides, which enhances nutrient absorption. Additionally, trypsin may influence various physiological processes by modulating protein signaling pathways, although these effects are less well-characterized compared to its digestive role.

Pharmacokinetics

Trypsin is typically administered exogenously in a proteolytic enzyme supplement form, particularly for conditions associated with pancreatic insufficiency. When taken orally, it is subject to degradation in the gastrointestinal tract; hence, it is often encapsulated to protect it from gastric acid. Its absorption is generally poor, and any systemic effects are limited due to rapid inactivation in the systemic circulation. Clinical studies indicate that trypsin may be absorbed in small amounts, but its primary use remains local to the gastrointestinal tract.

Contra-indications

  • Hypersensitivity to trypsin or any of its components
  • Active gastrointestinal bleeding
  • Severe renal impairment
  • History of pancreatitis

Adverse effects

  • Gastrointestinal disturbances such as nausea, vomiting, and diarrhea
  • Allergic reactions including rash and urticaria
  • Increased risk of bleeding
  • Local irritation at the site of administration

Interactions

  • Anticoagulants may have enhanced effects when used with trypsin due to its proteolytic activity
  • Corticosteroids may interfere with the action of trypsin
  • Other proteolytic enzymes may have additive effects

Precautions

  • Use with caution in patients with a history of allergies
  • Monitor for signs of bleeding in patients with clotting disorders
  • Evaluate renal function before initiating therapy
  • Caution in patients with a history of gastrointestinal disorders

Pregnancy

There are no well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is not known whether trypsin is excreted in human milk. Caution should be exercised when administering to nursing women.

Storage

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

Formulations

  • Enteric-coated tablets
  • Capsules
  • 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: units

Units are a measurement used in pharmacology to quantify the activity of a drug, particularly for substances that have effects that are not easily quantifiable in milligrams or grams. This measurement is often used for hormones, enzymes, and certain antigens, where the biological effect of a drug is more relevant than its weight. Units can vary depending on the substance and the context of its use.

Dosage

Children: Refer to specific drug guidelines as dosing in units varies based on the drug and its clinical application.

Adults: Refer to specific drug guidelines as dosing in units varies based on the drug and its clinical application.

Mechanism of action

The mechanism of action of drugs measured in units depends on the specific substance. For example, insulin (measured in units) facilitates glucose uptake in cells by binding to insulin receptors, activating a signaling pathway that enhances glucose transporter translocation to the cell membrane. This results in a decrease in blood glucose levels. Similarly, other drugs measured in units may exert their effects through receptor binding, enzyme catalysis, or other biochemical interactions.

Pharmacodynamics

Pharmacodynamics describes the effects of the drug on the body and includes the relationship between drug concentration and effect. For substances measured in units, the pharmacodynamic response may be variable and is often dependent on the individual’s sensitivity to the drug, receptor availability, and other pharmacological factors. For instance, the effect of 1 unit of insulin can vary significantly among individuals based on their insulin sensitivity and metabolic state.

Pharmacokinetics

Pharmacokinetics refers to the absorption, distribution, metabolism, and excretion of drugs. For substances measured in units, the pharmacokinetic profile can differ widely. For instance, insulin is rapidly absorbed when administered subcutaneously, distributed throughout the body, metabolized by the liver and kidneys, and its effects can be observed within minutes. Other drugs may have different absorption rates, half-lives, and routes of elimination.

Pregnancy

Consult a healthcare professional. The safety of this drug during pregnancy has not been established.

Breast-feeding

Consult a healthcare professional. The safety of this drug during breastfeeding has not been established.

Storage

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

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.