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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Non-Standardized Food Allergenic Extract [EPC]
Brucella Melitensis is a non-standardized allergenic extract used primarily in diagnostic settings to assess immunological sensitivity to Brucella antigens. It belongs to the class of Non-Standardized Food and Plant Allergenic Extracts.
Name
Brucella Melitensis
Raw Name
BRUCELLA MELITENSIS
Category
Non-Standardized Food Allergenic Extract [EPC]
Drug Count
4
Variant Count
4
Last Verified
February 17, 2026
About Brucella Melitensis
Brucella Melitensis is a non-standardized allergenic extract used primarily in diagnostic settings to assess immunological sensitivity to Brucella antigens. It belongs to the class of Non-Standardized Food and Plant Allergenic Extracts.
Detailed information about Brucella Melitensis
This page is for informational purposes only and does not replace medical advice. Consult a qualified healthcare professional before using any medication containing Brucella Melitensis.
Brucella Melitensis, in its pharmacological context, refers to a non-standardized allergenic extract derived from the Brucella melitensis bacterium. While the bacterium itself is the primary cause of brucellosis (also known as undulant fever or Malta fever) in humans and livestock, the extract is categorized by the FDA under the Established Pharmacologic Class (EPC) of Non-Standardized Food Allergenic Extract [EPC] and Non-Standardized Plant Allergenic Extract [EPC]. This classification is unique and reflects its use in immunological testing rather than as a traditional therapeutic agent.
Historically, extracts of Brucella species, often referred to as 'Brucellin,' were utilized in skin tests to detect delayed-type hypersensitivity (DTH) reactions in individuals suspected of having chronic brucellosis or prior exposure to the pathogen. Unlike standardized extracts, which have a defined potency (such as Bioequivalent Allergy Units), non-standardized extracts are manufactured according to traditional methods where the potency is not precisely quantified against a national reference standard. This drug class is primarily used by allergists and infectious disease specialists to evaluate the cell-mediated immune response.
According to the FDA's regulatory framework, these extracts are often maintained on the market based on historical use and clinical observation rather than modern randomized controlled trials. It is critical to understand that this extract is a diagnostic tool and not a vaccine or a treatment for active infection. Your healthcare provider may utilize this extract to determine if your immune system recognizes the Brucella antigen, which can be a vital piece of information in complex diagnostic cases involving zoonotic diseases (diseases transmitted from animals to humans).
The mechanism of action for Brucella Melitensis extract is centered on the human immune system's memory. When the extract is introduced into the skin (usually via intradermal injection), it acts as an exogenous antigen. If the patient has been previously sensitized to Brucella—either through infection or environmental exposure—their T-lymphocytes (specifically Th1 cells) will recognize the proteins and polysaccharides within the extract.
At the molecular level, this recognition triggers a Type IV hypersensitivity reaction, also known as a delayed-type hypersensitivity reaction. Upon recognition, the sensitized T-cells release various cytokines, including interferon-gamma and tumor necrosis factor (TNF). These signaling molecules recruit macrophages and other inflammatory cells to the site of the injection. Over a period of 24 to 72 hours, this cellular infiltration results in a palpable, firm area of skin known as an induration. The size and severity of this induration are measured to determine the degree of immunological sensitivity. In patients with no prior exposure, the extract should ideally produce no reaction, as there are no 'memory' T-cells to initiate the inflammatory cascade.
Because Brucella Melitensis extract is administered locally (intradermally) for diagnostic purposes, its pharmacokinetic profile differs significantly from systemic medications like tablets or intravenous infusions.
The primary FDA-recognized and clinical uses for Brucella Melitensis extract include:
It is important to note that modern serological tests (blood tests) and PCR (polymerase chain reaction) have largely supplanted skin testing for the diagnosis of acute brucellosis. However, the extract remains a specialized tool for assessing long-term immunological memory.
Brucella Melitensis extract is typically available in the following forms:
> Important: Only your healthcare provider can determine if Brucella Melitensis is right for your specific condition. The use of this extract must be conducted in a clinical setting equipped to handle potential allergic emergencies.
The dosage of Brucella Melitensis extract is highly specialized and must be determined by an allergist or immunologist.
Brucella Melitensis extract is not commonly used in pediatric populations unless specifically indicated by a specialist in pediatric infectious diseases or immunology.
No dosage adjustments are required for patients with renal impairment, as the systemic load of the extract is negligible.
No dosage adjustments are required for patients with hepatic impairment. The local metabolism of the extract by immune cells does not rely on liver function.
In elderly patients, the skin's reactivity may be diminished due to immunosenescence (the natural aging of the immune system). Healthcare providers may need to interpret results more conservatively, as a smaller induration might still indicate significant prior exposure in an older individual.
Brucella Melitensis extract is never self-administered. It must be administered by a trained healthcare professional in a medical facility.
As this is a diagnostic test, a 'missed dose' refers to a missed appointment for reading the skin reaction. If the reaction is not read within the 48-to-72-hour window, the test may be invalidated and may need to be repeated on the opposite arm after a period of time determined by your doctor.
An overdose of an allergenic extract occurs if too much volume is injected or if a concentration that is too high is used for a highly sensitive patient.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose or attempt to interpret your own skin test results without medical guidance.
Most patients receiving the Brucella Melitensis extract for diagnostic purposes will experience some level of local reaction. These are generally expected and indicate the test is functioning as intended.
> Warning: Stop the procedure and call your doctor immediately or seek emergency care if you experience any of the following symptoms after receiving the extract:
No FDA black box warnings are currently issued for Brucella Melitensis non-standardized extracts. However, all allergenic extracts carry an inherent risk of severe systemic reactions, and clinical guidelines mandate they be used only by professionals prepared to treat anaphylaxis.
Report any unusual symptoms to your healthcare provider. Even minor symptoms like a persistent cough or itchy palms after the injection should be reported immediately.
Brucella Melitensis extract is a potent immunological tool. It should only be used when the benefits of diagnostic clarity outweigh the risks of an allergic reaction. Patients must provide a full medical history, specifically highlighting any history of severe allergies, asthma, or previous reactions to diagnostic skin tests.
No FDA black box warnings for Brucella Melitensis. While many standardized extracts (like those for grass or mites) have black box warnings regarding the risk of anaphylaxis during immunotherapy, this diagnostic extract is used in a different clinical context. Nevertheless, the risk of systemic reaction is ever-present.
Generally, Brucella Melitensis extract does not affect the ability to drive or operate machinery. However, if a patient experiences a vasovagal reaction (fainting) or a systemic allergic reaction, they should not drive until cleared by a medical professional.
There are no direct pharmacological interactions between alcohol and Brucella Melitensis extract. However, alcohol can cause vasodilation (widening of blood vessels), which might theoretically increase the rate of absorption from the injection site or make a local reaction appear more severe.
Since this is a single-use diagnostic test, 'discontinuation' is not applicable in the same way as daily medication. However, if a patient has a severe reaction to the first dose of a multi-step testing protocol, the procedure must be stopped immediately.
> Important: Discuss all your medical conditions with your healthcare provider before starting Brucella Melitensis testing.
While few drugs 'react' chemically with Brucella Melitensis extract, several medications can interfere with the test's results or the safety of the procedure.
There are no known specific food interactions with Brucella Melitensis extract. Patients do not need to fast before the test. However, avoid heavy meals or caffeine if you are prone to feeling lightheaded during medical procedures.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking.
Brucella Melitensis extract must NEVER be used in the following circumstances:
There is a known cross-sensitivity between different Brucella species (B. melitensis, B. abortus, B. suis). If a patient is allergic to one, they are likely to react to the others. There is also some evidence of cross-reactivity with Yersinia enterocolitica and Vibrio cholerae antigens due to similarities in the O-polysaccharide chain of their lipopolysaccharides.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing Brucella Melitensis testing.
Brucella Melitensis extract is classified under FDA Pregnancy Category C (based on older labeling standards). There are no adequate and well-controlled studies in pregnant women.
It is not known whether the components of Brucella Melitensis extract are excreted in human milk. However, given the local nature of the injection and the proteinaceous structure of the antigens, it is highly unlikely that significant amounts would reach the breast milk or be absorbed by the nursing infant. The risk-benefit ratio usually favors testing if necessary, but nursing mothers should monitor their infants for any unusual skin rashes.
The safety and effectiveness of this extract in children have not been established. In pediatric cases where brucellosis is suspected, clinicians typically rely on serology (blood tests) and cultures. If a skin test is deemed necessary, it must be performed by a specialist in a controlled environment.
Clinical studies of Brucella Melitensis extract did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently than younger subjects. In general, elderly patients may have thinner skin and a less robust DTH response. Healthcare providers should be aware that a negative result in an elderly patient may be due to 'anergy' (the inability of the immune system to respond to any antigen) rather than a lack of exposure to Brucella.
No specific studies have been conducted in patients with renal impairment. However, since the extract is a protein-based substance administered in a minute dose for local effect, no accumulation or toxicity related to kidney function is expected.
Similarly, hepatic impairment is not expected to affect the safety or efficacy of the Brucella Melitensis extract. The liver is not involved in the primary processing or clearance of the intradermally injected antigens.
> Important: Special populations require individualized medical assessment by a specialist familiar with zoonotic diseases and immunology.
Brucella Melitensis extract functions as a diagnostic antigen. The extract contains a complex mixture of proteins, glycoproteins, and lipopolysaccharides derived from the Brucella melitensis cell wall. When injected intradermally, these antigens are taken up by local Langerhans cells (skin-resident dendritic cells). These cells process the antigens and present them on MHC Class II molecules to memory T-lymphocytes. If the patient has been previously sensitized, these T-cells are activated and release pro-inflammatory cytokines, resulting in the characteristic induration of a positive test.
| Parameter | Value |
|---|---|
| Bioavailability | Negligible (Local administration) |
| Protein Binding | N/A (Local action) |
| Half-life | Not systemically defined |
| Tmax | 48-72 hours (for induration) |
| Metabolism | Local Proteolysis |
| Excretion | Lymphatic clearance |
Brucella Melitensis belongs to the class of Non-Standardized Allergenic Extracts. It is grouped with other diagnostic bacterial antigens. Unlike standardized extracts (e.g., Cat Hair or Ragweed), the biological potency of Brucella Melitensis extract is not measured in international units, making it a 'non-standardized' product under FDA nomenclature.
Medications containing this ingredient
Common questions about Brucella Melitensis
Brucella Melitensis extract is primarily used as a diagnostic tool to detect if a person has been exposed to the *Brucella melitensis* bacterium in the past. It is administered through a skin test, similar to a TB test, to check for a delayed-type hypersensitivity reaction. This can help doctors understand a patient's immunological history, especially in cases of chronic or unexplained fever. It is not a vaccine and cannot be used to treat an active infection. Your healthcare provider will use this test as part of a broader diagnostic workup.
The most common side effects are local to the injection site and include redness, itching, and a hard, raised bump called an induration. These symptoms are actually what the doctor is looking for to determine a positive result. Some patients may also feel a bit tired or have a mild, low-grade fever for a day or two. Most of these local reactions peak around 48 to 72 hours after the injection. If the site becomes extremely painful or starts to blister, you should contact your doctor.
There is no known direct interaction between alcohol and the Brucella Melitensis extract. However, it is generally recommended to avoid alcohol for 24 hours before and after the test to ensure your body's immune response is not altered. Alcohol can cause your blood vessels to dilate, which might make a local skin reaction look more inflamed than it actually is. Additionally, if you have a reaction to the test, alcohol could make symptoms like dizziness or flushing worse. Always check with your healthcare provider for their specific recommendations.
The safety of Brucella Melitensis extract during pregnancy has not been fully established. While the extract itself stays mostly in the skin, the risk of a systemic allergic reaction (anaphylaxis) is a concern because it could affect the oxygen supply to the baby. Most doctors will only perform this skin test during pregnancy if it is absolutely necessary for the mother's health. If you are pregnant or planning to become pregnant, be sure to discuss the risks and benefits with your specialist. In many cases, the test may be postponed until after delivery.
As a diagnostic skin test, the 'results' of the Brucella Melitensis extract take time to develop. After the injection is given, you must wait 48 to 72 hours for the immune system to process the antigen and create a visible reaction. You will need to return to your doctor's office during this specific window so they can accurately measure the size of any bump that has formed. If the test is read too early or too late, the results may not be accurate. The redness may appear sooner, but the firm bump is the key indicator.
Brucella Melitensis extract is not a daily medication that you 'take' over time; it is a one-time diagnostic injection. Therefore, there is no concern about stopping it suddenly or experiencing withdrawal. Once the injection is administered, the process is started and cannot be 'stopped.' If you experience a severe reaction immediately after the injection, your doctor will treat the symptoms. You do not need to worry about tapering off this product as you would with steroids or antidepressants.
In the context of this diagnostic test, a 'missed dose' usually means missing the appointment to have the skin test read. If you do not return to your doctor within the 48-to-72-hour window, the test result will be invalid. You should call your healthcare provider immediately to reschedule. You may need to have the test repeated on a different part of your body at a later date. It is very important to keep the follow-up appointment to ensure the diagnostic process is successful.
No, Brucella Melitensis extract does not cause weight gain. It is a single-use diagnostic tool containing a very small amount of bacterial protein. It does not contain hormones, calories, or any substances that affect your metabolism or appetite. Any changes in weight you experience would be unrelated to this specific skin test. If you are experiencing unexpected weight changes, you should discuss them with your doctor to find the underlying cause.
While the extract doesn't 'interact' with most drugs in the traditional sense, some medications can interfere with the test results. For example, steroids or other immune-suppressing drugs can cause a false-negative result by preventing your immune system from reacting to the extract. Antihistamines can also mask the skin's reaction. It is vital to tell your doctor about all medications you are taking, including over-the-counter drugs and supplements, so they can tell you if you need to temporarily stop any of them before the test.
The concept of 'generic' vs. 'brand name' is slightly different for allergenic extracts. Brucella Melitensis is a non-standardized extract, and it is produced by a limited number of specialized laboratories. It is not a mass-market drug like ibuprofen. Most clinics will simply refer to it as 'Brucella Melitensis Extract' or 'Brucellin.' Because it is a specialized biological product, you won't find it at a typical retail pharmacy; it is sourced directly by the healthcare facilities that perform these specialized tests.