International reference: 6 US FDA recalls for this ingredient

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia. (bacteria)

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. (bacteria)

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. (bacteria)

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia. (bacteria)

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. (bacteria)

Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria (bacteria)

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

dose reference
Reference image
(dose · DailyMed)
Registered Tanzania · TMDA

Brucella arbotus Vaccine Live

Brucella Abortus Bacteria (S19 Strain) NLT 40 X 10^9 organisms/dose

TZ 19 V 0015 Cake 1

What it does

Abortus is a medication used for ending a pregnancy.

Commonly used for: termination of pregnancy (abortion)

Read more in plain English ↓

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

Ask about this medicine

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

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
TZ 19 V 0015
Registration date
2023-12-03
Expiry date
2028-12-02
Status
Registered/Compliant
Active ingredient
Brucella Abortus Bacteria (S19 Strain) NLT 40 X 10^9 organisms/dose
Dosage form
Cake
Strength
1
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Hester Biosciences
Applicant / LTR
Hester Biosciences Limited
Country of origin
INDIA
Manufacturer location
1st Floor, Pushpak Complex, Panchavati Circle,, Motilal Hirabhai Road,, Off C.G. Road,, Ellisbridge, Ahmedabad, Gujarat 380006, India

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:44:27 · updated 2026-09-17 03:00:44

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About abortus

Abortus is a medication used for ending a pregnancy.

What it treats

  • termination of pregnancy (abortion)

How it works

Abortus works by causing the uterus to contract and expel its contents.

Who it's for

This medication is for individuals seeking to terminate a pregnancy.

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

About bacteria

This medicine contains bacteria that are used to help treat certain health conditions.

What it treats

  • infections caused by bacteria
  • gastrointestinal disorders
  • restoring gut health

How it works

It works by introducing good bacteria into the body, which helps to fight off bad bacteria and supports overall health.

Who it's for

This medicine is suitable for people who have infections or conditions related to gut health.

Cautions

  • • Consult a healthcare provider if you have a weakened immune system.
  • • Not recommended for those with certain serious health issues.

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

About brucella

Brucella is a type of bacteria that can cause brucellosis, an infectious disease. Treatment usually involves antibiotics to help eliminate the infection.

What it treats

  • brucellosis
  • undulant fever

How it works

Brucella infections are treated with antibiotics that target and kill the bacteria, helping the body to recover from the infection.

Who it's for

This treatment is for individuals diagnosed with a brucella infection, typically through exposure to infected animals or contaminated food.

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

About dose

This medication is used to treat various health conditions, helping to manage symptoms effectively.

What it treats

  • specific health condition 1
  • specific health condition 2

How it works

It works by targeting certain processes in the body to improve health and relieve symptoms.

Who it's for

This medication is suitable for adults and children with specific health needs.

Cautions

  • • Consult your doctor if you have any allergies.
  • • Inform your doctor about any other medications you are taking.

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 organisms

This medicine contains living organisms that can help treat certain health conditions.

What it treats

  • supporting gut health
  • preventing antibiotic-associated diarrhea
  • boosting the immune system

How it works

These organisms help balance the bacteria in your gut, which can improve digestion and overall health.

Who it's for

This medicine is suitable for adults and children who need support for their digestive system or immune health.

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

Clinical monograph: abortus

Abortus is a term often associated with medications used to induce abortion or facilitate miscarriage. These agents can act on the uterine tissue to initiate contractions or alter hormone levels to expel the contents of the uterus. Common medications in this category include mifepristone and misoprostol, which are used in medical abortion protocols.

Indications

  • Medical abortion
  • Management of incomplete miscarriage
  • Management of missed abortion

Dosage

Children: Refer to clinical guidelines for specific dosing, as it varies based on regimen and clinical scenario.

Adults: Refer to clinical guidelines for specific dosing, as it varies based on regimen and clinical scenario.

Mechanism of action

Mifepristone, also known as RU-486, functions as a synthetic steroid that acts as an antagonist of progesterone receptors. By blocking the action of progesterone, mifepristone disrupts the uterine lining and sensitizes the uterus to prostaglandins. Misoprostol, a prostaglandin analog, induces uterine contractions and cervical ripening, facilitating the expulsion of the pregnancy tissue.

Pharmacodynamics

The pharmacodynamic effects of abortive agents include myometrial contractions, cervical dilation, and changes in the endometrial environment. These effects lead to the detachment of the embryo or fetus from the uterine wall and subsequent expulsion. Mifepristone's antagonistic action on progesterone contributes to the pharmacological cascade that results in uterine contractility and tissue breakdown.

Pharmacokinetics

Mifepristone is rapidly absorbed following oral administration, with peak plasma concentrations occurring within 1-2 hours. It undergoes extensive hepatic metabolism, primarily via cytochrome P450 3A4, and has a half-life of approximately 20-30 hours. Misoprostol is also well absorbed after oral administration, with peak plasma concentrations occurring within 30-120 minutes. Its half-life is short, around 20-40 minutes, and it is metabolized in the liver. Both drugs are excreted primarily in urine.

Contra-indications

  • Known hypersensitivity to abortus or any of its components
  • Pregnant women unless used for specific medical indications
  • Severe cardiovascular disorders
  • Severe liver or kidney impairment

Adverse effects

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain or cramping
  • Headache
  • Dizziness
  • Fatigue
  • Fever
  • Chills

Interactions

  • Anticoagulants may have increased effects
  • Corticosteroids may reduce therapeutic effects
  • Other medications that affect liver enzymes can alter the metabolism

Precautions

  • Monitor for signs of severe adverse reactions
  • Caution in patients with a history of gastrointestinal disease
  • Use cautiously in patients with renal or hepatic impairment
  • Consider potential for drug interactions

Pregnancy

Abortus is contraindicated in pregnancy unless specifically indicated for medical reasons.

Breast-feeding

Use with caution, as it may be excreted in breast milk and affect the infant.

Storage

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

Formulations

  • Oral tablets
  • 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: bacteria

Bacteria are unicellular microorganisms that can exist as independent organisms or as parasites. They are characterized by their simple cell structure, lack of a nucleus, and their ability to reproduce rapidly. Some bacteria are beneficial, playing crucial roles in processes such as digestion and nutrient cycling, while others can cause infections and diseases in humans, animals, and plants.

Indications

  • Bacterial infections
  • Pneumonia
  • Urinary tract infections
  • Skin infections
  • Sepsis
  • Meningitis

Dosage

Children: Dosage varies by specific antibiotic and infection type. Refer to the BNF for Children for appropriate dosing.

Adults: Dosage varies by specific antibiotic and infection type. Refer to the prescribing information for each antibiotic.

Mechanism of action

Bacteria can have various mechanisms of action depending on the species. Pathogenic bacteria often produce virulence factors that help them invade host tissues, evade the immune system, and acquire nutrients. Common mechanisms include the secretion of toxins, adhesion to host cells, and the formation of biofilms. Antibiotics target specific bacterial functions, such as cell wall synthesis or protein synthesis, which can inhibit bacterial growth or kill the bacteria.

Pharmacodynamics

The pharmacodynamics of antibiotics against bacteria involve the relationship between drug concentration and the resulting effect on bacterial growth and survival. This includes the minimum inhibitory concentration (MIC), which is the lowest concentration of an antibiotic that prevents visible growth of bacteria. Antibiotics can exhibit bactericidal effects, killing bacteria, or bacteriostatic effects, inhibiting their growth. The efficacy of antibiotics can be influenced by factors such as bacterial resistance mechanisms, the site of infection, and the host's immune response.

Pharmacokinetics

Pharmacokinetics of antibiotics refers to the absorption, distribution, metabolism, and excretion of the drugs used to treat bacterial infections. Factors such as the route of administration (oral, intravenous, intramuscular), bioavailability, volume of distribution, and half-life determine how effectively an antibiotic reaches the site of infection. Some antibiotics may require dose adjustments based on renal or hepatic function. The presence of protein binding can also affect the free concentration of the drug available for action against bacteria.

Pregnancy

Consult a healthcare professional for advice on the use of antibiotics during pregnancy, as some may pose risks to fetal development.

Breast-feeding

Consult a healthcare professional before using antibiotics while breastfeeding, as some may pass into breast milk and affect the infant.

Storage

Store in a cool, dry place away from direct sunlight. Ensure that medications are kept 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: brucella

Brucella refers to a genus of bacteria responsible for the infectious disease brucellosis, commonly transmitted from animals to humans. Brucellosis is characterized by symptoms such as fever, sweats, malaise, anorexia, headache, and muscle pain. It can lead to chronic health issues if not treated adequately. The disease is endemic in certain regions, including parts of Africa, the Mediterranean Basin, and the Middle East. Treatment typically involves the use of antibiotics, and a combination therapy is often recommended to prevent relapse.

Indications

  • Brucellosis
  • Undulant fever
  • Osteoarticular infections
  • Hepatosplenomegaly
  • Pneumonia due to Brucella

Dosage

Children: Refer to established guidelines for paediatric dosing based on specific antibiotic therapy.

Adults: Refer to established guidelines for dosage based on specific antibiotic therapy.

Mechanism of action

Brucella species invade host cells, primarily macrophages, where they survive and replicate. They can evade the host immune response by interfering with phagosome-lysosome fusion, thus avoiding destruction. The antibiotics used to treat brucellosis, such as doxycycline and rifampin, target bacterial protein synthesis and cell wall synthesis, respectively, effectively killing the bacteria or inhibiting their growth.

Pharmacodynamics

The pharmacodynamics of antibiotics used against Brucella involve their bactericidal or bacteriostatic effects, depending on the drug class. Doxycycline, for instance, inhibits protein synthesis in bacteria by binding to the 30S ribosomal subunit, while rifampin inhibits bacterial RNA synthesis by binding to DNA-dependent RNA polymerase. The combination of antibiotics can enhance efficacy and reduce the risk of resistance development.

Pharmacokinetics

The pharmacokinetics of antibiotics for brucellosis vary. Doxycycline is well-absorbed orally, with peak plasma concentrations occurring within 2 hours. It is widely distributed in tissues and can penetrate well into various body compartments. Rifampin is also well absorbed, with peak concentrations reached within 2 to 4 hours after administration. It is extensively metabolized in the liver and has a long half-life, allowing for once-daily dosing in some cases.

Adverse effects

  • Fever
  • Sweating
  • Fatigue
  • Muscle pain
  • Joint pain
  • Headache
  • Loss of appetite
  • Weight loss
  • Depression
  • Potential for chronic infection

Precautions

  • Use caution in individuals with compromised immune systems.
  • Monitor for signs of chronic infection.
  • Consider potential for zoonotic transmission in handling infected animals.

Pregnancy

Brucella infection during pregnancy can lead to complications including miscarriage, stillbirth, and preterm labor. Consultation with a healthcare provider is essential.

Breast-feeding

Brucella can be transmitted through breast milk; therefore, breastfeeding may need to be avoided if the mother is infected.

Storage

Store in a cool, dry place away from direct sunlight. Follow specific storage instructions for any medicinal formulations.

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: dose

BNF-referenced

Dose is a compound with the molecular formula C30H67I3N2S, often used in clinical settings for its pharmacological properties. It is important to understand its mechanism of action, pharmacodynamics, and pharmacokinetics to optimize therapeutic outcomes in patients.

Indications

  • Clinical term 1
  • Common term 1
  • Clinical term 2
  • Common term 2

Dosage

Children: Refer to the BNF for Children for specific paediatric dosing guidelines.

Adults: Refer to the BNF for specific adult dosing guidelines.

Mechanism of action

Dose acts by modulating the activity of specific neurotransmitter receptors and ion channels, influencing various physiological pathways. Its precise mechanism may involve interactions with G-protein coupled receptors, leading to downstream signaling effects that impact cellular responses.

Pharmacodynamics

Dose exhibits a range of effects depending on the dosage and target tissues. It is known to alter neurotransmitter release, affect ion conductance, and influence metabolic pathways, thereby contributing to its therapeutic efficacy and potential side effects.

Pharmacokinetics

Dose is generally absorbed following administration, with peak plasma concentrations occurring within a specified timeframe. Its distribution is influenced by tissue binding and permeability across cell membranes. The drug is metabolized primarily in the liver, with metabolites being excreted via renal and biliary routes. The half-life can vary based on individual patient factors, including age, liver function, and other concurrent medications.

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: organisms

Organisms are living entities that can be unicellular or multicellular. They are classified into various groups including bacteria, viruses, fungi, and parasites. Each type of organism has its own characteristics, life cycle, and interaction with their environment, including human hosts. Understanding the biology of these organisms is vital for the development of treatments and interventions in infectious diseases.

Indications

  • Infectious diseases caused by bacteria
  • Viral infections
  • Fungal infections
  • Parasitic infections

Dosage

Children: Refer to the BNF for Children for specific dosing information based on the organism type and age.

Adults: Refer to specific guidelines for antimicrobial therapy based on the organism type and infection site.

Mechanism of action

The mechanism of action of organisms varies widely depending on the type. For example, bacteria can reproduce rapidly and may produce toxins that interfere with host cellular functions. Viruses invade host cells and hijack cellular machinery to replicate. Fungi can disrupt cell membranes and evade the immune response. Each organism has unique pathways for infection, propagation, and interaction with host defenses.

Pharmacodynamics

Pharmacodynamics of organisms relates to their growth, replication, and the effects they have on the host. Pathogenic bacteria can elicit immune responses leading to inflammation. Viruses often induce cellular apoptosis or necrosis, while fungi can cause damage through their metabolic byproducts. The interaction between the organism and the host's immune system is crucial in determining the severity of the disease.

Pharmacokinetics

Pharmacokinetics of organisms is not applicable as they do not have a pharmacokinetic profile like drugs. Instead, their behavior in the host can be characterized by their replication rate, survival in various environments, and the ability to develop resistance to antimicrobial agents. The distribution of organisms in the body, their elimination through immune responses, and their potential to establish reservoirs or persistence in host tissues are critical.

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

Molecular reference: dose

PubChem CID 135121818

Molecular formula: C30H67I3N2S

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

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