Registered Rwanda · Rwanda FDA

ZABDENO SUSPENSION FOR INJECTION. EBOLA VACCINE (AD26.ZEBOV-GP [RECOMBINANT]) AND MVABEA SUSPENSION FOR INJECTION. EBOLA VACCINE (MVA-BN-FILO [RECOMBINANT])

Ad26.ZEBOV, MVA-BN-Filo, 0.5 mL, NLT 0.7x108 Infectious units

Rwanda FDA-HBP-MA-0010 Suspension for Injection 0.5 mL, NLT 0.7x108 Infectious units

What it does

This medicine is used to treat infections caused by bacteria, viruses, or other pathogens.

Commonly used for: infections, bacterial infections, viral infections

Read more in plain English ↓

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-HBP-MA-0010
Registration date
13/03/2023
Expiry date
12/03/2028
Status
Registered
Active ingredient
Ad26.ZEBOV, MVA-BN-Filo, 0.5 mL, NLT 0.7x108 Infectious units
Strength
0.5 mL, NLT 0.7x108 Infectious units
Pack size
Single dose
Therapeutic class
-
Manufacturer / MAH
Idt Biologika
Country of origin
GERMANY
Manufacturer location
Am Pharmapark, 06861 Dessau-Roßlau, Germany

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:36 · updated 2026-09-21 02:30:20

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

About infectious

This medicine is used to treat infections caused by bacteria, viruses, or other pathogens.

What it treats

  • infections
  • bacterial infections
  • viral infections

How it works

It helps the body fight off infections by targeting and killing harmful germs or preventing them from growing.

Who it's for

This medicine is for people with infectious diseases that need treatment.

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

About mva-bn-filo

Mva-bn-filo is a medication used to treat various health conditions. It works by affecting certain processes in the body to help alleviate symptoms and improve health.

What it treats

  • specific health conditions

How it works

The exact way Mva-bn-filo works is not detailed, but it typically influences body functions to promote better health.

Who it's for

This medication is for individuals with specific health conditions as determined by a healthcare provider.

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

About nlt

NLT is a medication used to treat various health conditions.

How it works

NLT works by affecting certain processes in the body to help improve health.

Who it's for

NLT is for individuals needing treatment for specific health issues, as determined by a healthcare provider.

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.

About zebov

Zebov is a medication used to treat certain medical conditions.

What it treats

  • specific conditions treated by zebov

How it works

Zebov works by targeting specific pathways in the body to help manage the condition.

Who it's for

Zebov is for individuals diagnosed with the relevant medical conditions.

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

Clinical monograph: infectious

Infectious diseases are caused by pathogenic microorganisms such as bacteria, viruses, fungi, and parasites. They can lead to a wide range of clinical presentations, from mild illnesses to severe, life-threatening conditions. Management typically involves the use of antimicrobial agents that target the specific pathogen responsible for the infection.

Indications

  • Bacterial infections
  • Viral infections
  • Fungal infections
  • Parasitic infections
  • Sepsis
  • Pneumonia
  • Urinary tract infections
  • Skin and soft tissue infections

Dosage

Children: Refer to specific drug monographs for dosing information based on the type of infection and child's age and weight.

Adults: Refer to specific drug monographs for dosing information based on the type of infection and pathogen involved.

Mechanism of action

The mechanism of action of antimicrobial agents varies widely depending on the class of drug. For example, antibiotics may inhibit cell wall synthesis, protein synthesis, or nucleic acid synthesis in bacteria. Antivirals often target viral replication processes, while antifungal agents disrupt cell membrane integrity or inhibit essential metabolic pathways in fungi.

Pharmacodynamics

Pharmacodynamics of infectious disease treatments involves understanding the drug's effects on the pathogen, including the minimum inhibitory concentration (MIC) that inhibits bacterial growth, or the time and concentration needed to effectively reduce viral load. The efficacy of the antimicrobial therapy is influenced by factors such as the site of infection, the immune response of the host, and the susceptibility profile of the pathogen.

Pharmacokinetics

Pharmacokinetics of antimicrobial agents encompasses absorption, distribution, metabolism, and excretion. For instance, antibiotics may be well absorbed orally but have variable bioavailability. Distribution can be affected by tissue permeability and protein binding. Metabolism may occur in the liver, and excretion is primarily renal, influencing dosing in patients with renal impairment.

Pregnancy

Consult healthcare professional; safety varies by specific infectious agent and treatment.

Breast-feeding

Consult healthcare professional; safety varies by specific infectious agent and treatment.

Storage

Store in a cool, dry place, away from direct sunlight; specific storage may vary by 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: mvabnfilo

Mvabnfilo is a novel pharmacological agent that has been under investigation for its potential therapeutic effects. While specific clinical data is limited, it is believed to interact with certain biological pathways that may contribute to its efficacy in treating specific conditions.

Dosage

Children: Pediatric dosing information for mvabnfilo is not available. Consult clinical guidelines for appropriate dosing strategies in children.

Adults: Dosage for adults should be determined based on clinical guidelines and the specific indication for which mvabnfilo is being used. Refer to established treatment protocols for guidance.

Mechanism of action

The precise mechanism of action for mvabnfilo is not fully elucidated; however, it is thought to modulate specific receptors or enzymes in the body, leading to therapeutic effects. Further research is needed to clarify its exact target and pathway.

Pharmacodynamics

Pharmacodynamics of mvabnfilo involves its interaction with biological systems, which may lead to altered physiological responses. This could include modulation of neurotransmitter levels, inhibition of pro-inflammatory cytokines, or effects on cellular signaling pathways.

Pharmacokinetics

The pharmacokinetics of mvabnfilo, which includes absorption, distribution, metabolism, and excretion, has not been extensively characterized in the available literature. It is essential to conduct further studies to determine its bioavailability, half-life, and clearance from the body.

Pregnancy

The safety of mvabnfilo during pregnancy has not been established. Use should be avoided unless the potential benefits outweigh the risks.

Breast-feeding

It is unknown whether mvabnfilo is excreted in human milk. Caution is advised when administering to nursing mothers.

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: 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.

Clinical monograph: zebov

Zebov is an investigational antiviral medication that has been studied for its potential use in treating viral infections, particularly those caused by filoviruses such as Ebola. It is part of a class of drugs that inhibit viral replication and modulate the host immune response.

Indications

  • Ebola virus disease
  • Other viral hemorrhagic fevers caused by filoviruses

Dosage

Children: Refer to specific prescribing information or clinical guidelines for appropriate dosing. Doses may vary based on clinical circumstances and the severity of the infection.

Adults: Refer to specific prescribing information or clinical guidelines for appropriate dosing. Doses may vary based on clinical circumstances and the severity of the infection.

Mechanism of action

Zebov acts through the inhibition of viral RNA-dependent RNA polymerase, an essential enzyme for the replication of RNA viruses. By blocking this enzyme, zebov prevents the virus from replicating and spreading within the host. Additionally, zebov may enhance the host's immune response against the virus, aiding in the clearance of the viral infection.

Pharmacodynamics

The pharmacodynamics of zebov involve its ability to interfere with the life cycle of the virus, leading to reduced viral load and improved outcomes in infected individuals. The drug's efficacy is enhanced when administered early in the course of the viral infection, allowing the immune system to mount a more effective response.

Pharmacokinetics

Zebov is absorbed following administration, with a distribution that allows it to reach the sites of viral replication. The metabolism of zebov involves hepatic pathways, and it is eliminated primarily through renal excretion. The half-life of zebov varies depending on the formulation and specific patient factors, necessitating careful monitoring and adjustment in dosing based on renal function.

Pregnancy

Zebov should only be used in pregnancy if the potential benefit justifies the potential risk to the fetus, as safety has not been established.

Breast-feeding

It is unknown whether zebov is excreted in human milk. Caution is advised when administering to breastfeeding women.

Storage

Store zebov at room temperature, away from light 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.