Registered Zambia · ZAMRA

Prondivax Vaccine

Clostridium haemolyticum 0 IU,Clostridium novyi Strain 2.5 IU,Clostridium perfringens Type C Strain A 10 IU,Clostridium perfringens Type D 2 IU

471/707V Solution for Injection 0 IU,10 IU,2 IU,2.5 IU

What it does

Clostridium is a type of bacteria that can be involved in certain medical treatments, particularly for infections.

Commonly used for: infections caused by Clostridium bacteria, Clostridium difficile infection (CDI)

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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.
471/707V
Registration date
2025-12-13
Expiry date
2030-12-12
Status
Registered/Compliant
Active ingredient
Clostridium haemolyticum 0 IU,Clostridium novyi Strain 2.5 IU,Clostridium perfringens Type C Strain A 10 IU,Clostridium perfringens Type D 2 IU
Strength
0 IU,10 IU,2 IU,2.5 IU
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Prondil
Country of origin
Uruguay
Manufacturer location
Barros Arana 5402, 13000 Montevideo, Departamento de Montevideo, Uruguay

Source: Zambia Medicines Regulatory Authority · fetched 2026-03-12 00:07:06 · updated 2026-11-02 06:25:41

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

About clostridium

Clostridium is a type of bacteria that can be involved in certain medical treatments, particularly for infections.

What it treats

  • infections caused by Clostridium bacteria
  • Clostridium difficile infection (CDI)

How it works

Clostridium-based treatments can help restore the balance of healthy bacteria in the gut, especially after antibiotic use.

Who it's for

This treatment is usually for individuals with specific bacterial infections, particularly those affecting the digestive system.

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

About haemolyticum

Haemolyticum is a substance that may affect red blood cells and is used in certain medical conditions.

What it treats

  • anemia (low red blood cell count)
  • hemolytic disease

How it works

It helps manage issues related to red blood cells, particularly in cases where they are destroyed more quickly than they can be made.

Who it's for

This treatment may be suitable for patients experiencing problems with their red blood cells.

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

About novyi

Novyi is a medication that may be used to treat certain health conditions, but specific information about its uses and interactions is not provided.

How it works

The exact way Novyi works is not detailed, but it is meant to help manage specific health issues.

Who it's for

Novyi may be prescribed for individuals with certain medical conditions, depending on a doctor's assessment.

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

About perfringens

Perfringens is not commonly used as a medicine, but it is a type of bacteria that can cause infections.

What it treats

  • infections caused by Clostridium perfringens

How it works

Perfringens bacteria can produce toxins that damage tissues and cause illness.

Who it's for

Individuals with infections related to Clostridium perfringens.

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

About strain

Strain is a type of medicine used to help with various health conditions.

What it treats

  • muscle pain
  • injuries
  • sports injuries

How it works

Strain helps relieve pain and reduce inflammation in the affected areas.

Who it's for

It is suitable for people experiencing muscle pain or injuries.

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

Clinical monograph: clostridium

Clostridium refers to a genus of bacteria known for its ability to form spores and produce toxins. Species such as Clostridium botulinum, Clostridium tetani, and Clostridium difficile are of particular clinical significance due to their role in various diseases. Clostridium infections can lead to conditions such as botulism, tetanus, and antibiotic-associated colitis, which can be severe and require urgent medical attention.

Indications

  • Botulism
  • Tetanus
  • Clostridium difficile infection
  • Pseudomembranous colitis

Dosage

Adults: Refer to specific clinical guidelines for dosage based on the condition being treated, as Clostridium infections require targeted therapies and may involve antitoxins, antibiotics, or supportive

Mechanism of action

Clostridium species produce potent exotoxins that interfere with normal cellular functions. For instance, Clostridium botulinum produces botulinum toxin, which inhibits acetylcholine release at the neuromuscular junction, leading to paralysis. Clostridium tetani produces tetanospasmin, which blocks inhibitory neurotransmitter release in the central nervous system, resulting in muscle spasms. Clostridium difficile releases toxins A and B, which disrupt the intestinal epithelium and cause inflammation, leading to diarrhea.

Pharmacodynamics

The pharmacodynamic effects of Clostridium toxins are primarily driven by their enzymatic activities. Botulinum toxin is the most potent toxin known and acts at neuromuscular junctions, causing flaccid paralysis. Tetanospasmin affects central nervous system neurotransmission, leading to spastic paralysis. Toxins produced by Clostridium difficile lead to cell death and inflammatory responses in the colon, contributing to pseudomembranous colitis.

Pharmacokinetics

The pharmacokinetics of Clostridium infections vary by species and toxin type. Generally, the toxins are absorbed into circulation following local release at infection sites. For example, botulinum toxin is absorbed through the gastrointestinal tract when ingested and distributed throughout the body, while tetanospasmin acts locally and is transported retrograde along motor neurons to the central nervous system. The duration of action is influenced by the toxin's ability to bind to receptors and enter cells, as well as the body's capacity for toxin clearance.

Pregnancy

The safety of clostridium species during pregnancy has not been established. Caution is advised when administering to pregnant individuals.

Breast-feeding

The effects of clostridium species during breastfeeding are not well studied. Caution is recommended.

Storage

Store in a cool, dry place away from direct sunlight. Specific storage conditions may vary based on formulation.

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: haemolyticum

Haemolyticum refers to a group of bacteria known to cause hemolysis, the destruction of red blood cells. This condition is typically associated with infections caused by certain strains of Streptococcus, particularly Streptococcus pyogenes, which can lead to various clinical manifestations such as pharyngitis, scarlet fever, and rheumatic fever. Understanding haemolyticum is essential in the context of its clinical implications, treatment options, and potential complications.

Indications

  • Streptococcal pharyngitis
  • Scarlet fever
  • Rheumatic fever
  • Skin infections (e.g., impetigo)
  • Post-streptococcal glomerulonephritis

Dosage

Children: Refer to BNF for Children for specific dosing recommendations based on the antibiotic choice and severity of the

Adults: Refer to BNF for specific dosing recommendations based on the antibiotic choice and severity of the infection.

Mechanism of action

The mechanism of action for haemolyticum organisms primarily involves the production of hemolysins, which are toxins that can lyse red blood cells. These hemolysins disrupt the integrity of cell membranes, leading to cell lysis and the release of hemoglobin. This process not only aids in the bacteria's nutritional requirements but also contributes to the pathogenicity of the infection by evading the host's immune response.

Pharmacodynamics

Pharmacodynamically, the effects of haemolyticum infections can result in significant inflammatory responses, leading to symptoms such as fever, sore throat, and, in more severe cases, systemic complications. The presence of hemolysins can also trigger an immune response, which may contribute to tissue damage and the clinical manifestations associated with streptococcal infections. The severity of symptoms often correlates with the extent of hemolysis and the body's immune response.

Pharmacokinetics

Pharmacokinetics of haemolyticum infections are not directly applicable as they pertain to the pharmacokinetics of antibiotics used to treat these infections. However, in general, antibiotics such as penicillin are administered to clear the infection, with pharmacokinetics varying based on the specific antibiotic used. Factors such as absorption, distribution, metabolism, and excretion will influence the effectiveness of treatment against the pathogens responsible for haemolyticum.

Pregnancy

There is limited information on the safety of haemolyticum during pregnancy. It should only be used if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Caution is advised when using haemolyticum during breastfeeding, as it may be excreted in breast milk.

Storage

Store at room temperature, away from moisture and heat. 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.

Clinical monograph: novyi

Novyi is a novel pharmaceutical agent that is being researched for its therapeutic potential. It is part of ongoing studies aimed at understanding its safety, efficacy, and application in various medical conditions. As it is a new entry in the pharmaceutical landscape, comprehensive clinical guidelines and dosing information are still being established.

Dosage

Children: Dosing information for paediatric populations is not established. Consult relevant pediatric dosing guidelines and clinical resources as data emerges.

Adults: Dosing information for adults is not yet established. Clinical trials and studies are ongoing to determine appropriate dosing regimens. Refer to official guidelines as they become available.

Mechanism of action

The precise mechanism of action for Novyi is not fully elucidated, but it is believed to interact with specific molecular targets in the body, potentially modulating biological pathways that influence disease states. Further research is necessary to clarify its pharmacological effects and the specific receptors or enzymes it may affect.

Pharmacodynamics

Novyi exhibits a range of pharmacodynamic activities which are under investigation. Early studies suggest that it may influence cellular signaling pathways, alter gene expression, or have effects on neurotransmission or immune responses. The full extent of its pharmacodynamic profile is still under research.

Pharmacokinetics

The pharmacokinetics of Novyi, including absorption, distribution, metabolism, and excretion (ADME), is currently being studied. Initial findings suggest variable bioavailability, with ongoing assessments to determine its half-life and potential interactions with other drugs. Understanding its pharmacokinetic properties is crucial in defining appropriate dosing regimens.

Pregnancy

The safety of novyi during pregnancy has not been established. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is not known if novyi is excreted in human milk. Caution should be exercised when administering to a nursing mother.

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.

Clinical monograph: perfringens

Perfringens is a term commonly associated with Clostridium perfringens, a bacterium known to cause various infections, including gas gangrene and food poisoning. The organism produces a range of toxins that can lead to tissue necrosis and systemic illness. Treatment often involves the use of antibiotics and surgical intervention to remove necrotic tissue.

Indications

  • Gas gangrene
  • Clostridial myonecrosis
  • Food poisoning
  • Soft tissue infections

Dosage

Children: Refer to specific antibiotic guidelines for dosing as it varies by drug choice and severity of the infection.

Adults: Refer to specific antibiotic guidelines for dosing as it varies by drug choice and severity of the infection.

Mechanism of action

Clostridium perfringens produces several toxins, including alpha-toxin (lecithinase), which disrupts cell membranes and promotes tissue destruction. The toxins act on phospholipids in cell membranes, leading to cell lysis and necrosis. Additionally, the bacterium's ability to produce gas (hydrogen and carbon dioxide) contributes to tissue swelling and further compromises blood flow.

Pharmacodynamics

The pharmacodynamics of antibiotics used against Clostridium perfringens involve the inhibition of bacterial cell wall synthesis (for beta-lactams), disruption of protein synthesis (for aminoglycosides and tetracyclines), or interference with nucleic acid synthesis (for fluoroquinolones). The effectiveness of these antibiotics can vary based on the specific strain and its susceptibility profile.

Pharmacokinetics

Pharmacokinetic properties depend on the specific antibiotic used to treat Clostridium perfringens infections. Generally, antibiotics may have varying absorption rates, distribution volumes, half-lives, and elimination routes, which can influence their dosing and effectiveness in treating infections caused by this organism.

Pregnancy

Perfringens is not typically used as a medication but is related to Clostridium perfringens, which is associated with foodborne illness. Consult healthcare providers for guidance during pregnancy.

Breast-feeding

Due to the lack of specific medicinal use, consult healthcare providers for advice regarding breastfeeding.

Storage

Store in a cool, dry place away from direct sunlight. If used in a laboratory context, follow specific biosafety guidelines.

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: strain

Strain refers to a specific variant of a microorganism, such as bacteria or viruses, that has distinct genetic characteristics. In clinical contexts, strains are often discussed in relation to their pathogenicity, resistance to antibiotics, and epidemiological significance. Understanding the specific strain of a pathogen is critical for effective treatment decisions and public health responses.

Indications

  • Bacterial infections
  • Viral infections
  • Epidemiological studies
  • Antibiotic resistance monitoring

Dosage

Children: Refer to specific antimicrobial treatment guidelines based on the strain identified and the infection site.

Adults: Refer to specific antimicrobial treatment guidelines based on the strain identified and the infection site.

Mechanism of action

The mechanism of action for a strain depends on the type of microorganism it represents. For pathogenic bacteria, the strain may produce toxins, evade the host's immune response, or possess resistance mechanisms that allow it to survive in the presence of antibiotics. For viruses, strains may exhibit mutations that alter their ability to infect host cells or evade antiviral therapies.

Pharmacodynamics

Pharmacodynamics in the context of strains involves the interaction between the strain and the host's immune system, as well as the effects of specific antimicrobial agents on the strain. These interactions can influence the efficacy of treatments and the development of resistance.

Pharmacokinetics

Pharmacokinetics is not directly applicable to strains themselves but rather to the drugs used to treat infections caused by specific strains. Factors such as absorption, distribution, metabolism, and excretion of antimicrobial agents can vary depending on the strain's characteristics and the site of infection.

Pregnancy

There is limited information on the safety of strain in pregnancy. It is advisable to consult healthcare professionals for guidance.

Breast-feeding

Safety during breastfeeding is not well established. It is recommended to seek medical advice before use.

Storage

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