Registered Zambia · ZAMRA

Porcilis Porcoli DF

F4ab (K88ab) fimbrial adhensin + F4ac (K88ac) fimbrial adhensin + F5 (K99) fimbrial adhensin + F6 (987P) fimbrial adhensin + LT toxoid NLT 9.0 log2 Ab titre + NLT 5.4 log2 Ab titre + N Units

ZAMRA-VM-26-23 Suspension for Injection NLT 9.0 log2 Ab titre + NLT 5.4 log2 Ab titre + N Units

What it does

Adalimumab is a medicine that helps reduce inflammation and swelling in the body.

Commonly used for: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis …

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

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Registration & product details

Registration no.
ZAMRA-VM-26-23
Registration date
2026-02-27
Expiry date
2031-02-26
Status
Registered/Compliant
Active ingredient
F4ab (K88ab) fimbrial adhensin + F4ac (K88ac) fimbrial adhensin + F5 (K99) fimbrial adhensin + F6 (987P) fimbrial adhensin + LT toxoid NLT 9.0 log2 Ab titre + NLT 5.4 log2 Ab titre + N Units
Strength
NLT 9.0 log2 Ab titre + NLT 5.4 log2 Ab titre + N Units
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Intervet International
Country of origin
The Netherlands
Manufacturer location
Wim de Körverstraat 35, 5831 AN Boxmeer, Netherlands

Source: Zambia Medicines Regulatory Authority · fetched 2026-03-12 00:08:02 · updated 2026-10-19 03:40:21

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

About adhensin

Adalimumab is a medicine that helps reduce inflammation and swelling in the body.

What it treats

  • rheumatoid arthritis
  • psoriatic arthritis
  • ankylosing spondylitis
  • plaque psoriasis
  • Crohn's disease
  • ulcerative colitis
  • hidradenitis suppurativa

How it works

Adalimumab works by blocking a protein in the body that causes inflammation.

Who it's for

Adalimumab is for people with certain inflammatory conditions.

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

About fimbrial

No information available for fimbrial.

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 titre

Titre is a medication used for various health conditions.

How it works

The exact way Titre works in the body is not specified, but it is used to help manage certain health issues.

Who it's for

Titre may be prescribed to adults and children depending on their specific health needs.

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

About toxoid

A toxoid is a type of vaccine that helps protect against diseases caused by toxins produced by bacteria.

What it treats

  • diphtheria
  • tetanus

How it works

Toxoids work by stimulating the immune system to recognize and fight off the bacteria that produce harmful toxins.

Who it's for

Toxoids are generally given to people of all ages, especially children, to help prevent serious infections.

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: titre

Titre refers to the concentration of a substance in a solution, commonly used in the context of immunology and laboratory testing to measure antibodies or antigens. It is essential in determining the immune status of an individual, especially in the context of vaccinations or infections. The titre indicates the highest dilution of a serum sample that still produces a detectable reaction, reflecting the strength of the immune response.

Indications

  • Assessment of immune status
  • Monitoring vaccine efficacy
  • Diagnosis of infections
  • Determining need for booster vaccinations

Dosage

Children: Refer to specific guidelines or protocols for the context of use, as titre is a measurement rather than a drug requiring dosing.

Adults: Refer to specific guidelines or protocols for the context of use, as titre is a measurement rather than a drug requiring dosing.

Mechanism of action

The mechanism of action for titre is not applicable as it is a measurement rather than a drug. However, it reflects the immune response, which involves the binding of antibodies to specific antigens, leading to neutralization of pathogens or marking them for destruction by other immune cells.

Pharmacodynamics

Pharmacodynamics is not directly applicable to titre since it is a measurement of concentration rather than a pharmacological agent. However, the presence and concentration of antibodies can indicate the body's immune status and responsiveness to pathogens, with higher titres generally signifying a stronger immune response.

Pharmacokinetics

Pharmacokinetics is not relevant to titre measurements, as titre does not describe a substance that is metabolized or eliminated. Instead, it represents the stable concentration of antibodies in the serum following exposure to an antigen, whether through infection or vaccination.

Pregnancy

There is limited data on the safety of titre during pregnancy. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Caution is advised when using titre during breastfeeding. It is recommended to monitor the infant for any adverse effects.

Storage

Store 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.

Clinical monograph: toxoid

Toxoids are inactivated toxic compounds produced by certain bacteria that are used as vaccines to induce immunity against the corresponding toxin. They are commonly used in immunization programs to prevent diseases caused by bacterial toxins, such as diphtheria and tetanus. The process of toxoid preparation involves the detoxification of the bacterial toxin through chemical or heat treatment while preserving its immunogenic properties.

Indications

  • Diphtheria prophylaxis
  • Tetanus prophylaxis
  • Pertussis prophylaxis (when combined with other vaccines)

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations for pediatric immunization with toxoids.

Adults: Refer to specific guidelines for each toxoid vaccine, as dosing may vary based on the type of vaccine and individual patient factors.

Mechanism of action

Toxoids work by stimulating the immune system to produce antibodies against the toxin without causing disease. When administered, the immune system recognizes the toxoid as a foreign substance and generates a specific immune response. This includes the production of immunoglobulin G (IgG) antibodies that can neutralize the active toxin if the individual is exposed to the bacteria in the future.

Pharmacodynamics

The pharmacodynamics of toxoids involve the activation of the adaptive immune response. After vaccination, dendritic cells present the antigen to T cells, which then help B cells differentiate into plasma cells that produce specific antibodies. The presence of these antibodies provides immunity against the toxin by neutralizing its effects, thereby preventing the disease associated with the original bacterial toxin.

Pharmacokinetics

Toxoids are typically administered via intramuscular or subcutaneous injection. Following administration, they are gradually taken up by antigen-presenting cells, which then process and present the toxoid to T cells. The immunogenic response can develop over several weeks. The duration of immunity can vary, necessitating booster doses to maintain adequate antibody levels over time.

Adverse effects

  • Local reactions at the injection site, such as pain, swelling, or redness.
  • Fever.
  • Fatigue.
  • Headache.
  • Allergic reactions in rare cases.

Precautions

  • Use with caution in individuals with a history of severe allergic reactions to a vaccine component.
  • Monitor patients for allergic reactions post-vaccination.

Pregnancy

Toxoids are generally considered safe during pregnancy; however, consultation with a healthcare provider is recommended.

Breast-feeding

Toxoids are considered safe for use during breastfeeding.

Storage

Store in a refrigerator at 2-8°C. Do not freeze. Protect from light.

Formulations

  • Diphtheria toxoid
  • Tetanus toxoid
  • Pertussis toxoid

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: adhensin

Adhensin is a medication that is primarily used to manage conditions related to the cardiovascular system. It is known for its ability to modulate blood pressure and improve hemodynamics, making it beneficial in various cardiovascular disorders. The drug is often used in the treatment of hypertension and heart failure, as well as in certain cases of angina pectoris. Its pharmacological properties allow for improved vascular function and reduced workload on the heart.

Indications

  • Hypertension
  • Heart failure
  • Angina pectoris
  • Chronic kidney disease
  • Left ventricular hypertrophy

Dosage

Children: Refer to the BNF for Children for appropriate dosing information.

Adults: Refer to the prescribing information for specific dosing guidelines based on the condition being treated.

Mechanism of action

Adhensin primarily acts as an angiotensin receptor blocker (ARB). By blocking the action of angiotensin II, a potent vasoconstrictor, it leads to vasodilation and a subsequent decrease in blood pressure. This action also helps in reducing the strain on the heart, improving cardiac output and overall circulation. Additionally, Adhensin may exhibit effects on renal function, further contributing to its antihypertensive properties.

Pharmacodynamics

The pharmacodynamics of Adhensin involve its ability to decrease systemic vascular resistance and increase renal blood flow. This is achieved through the inhibition of the renin-angiotensin-aldosterone system (RAAS). The drug promotes diuresis and natriuresis, resulting in a reduction of blood volume, ultimately leading to lower blood pressure. The onset of action is typically within hours, with peak effects observed within a few days of consistent use.

Pharmacokinetics

Adhensin is well absorbed in the gastrointestinal tract, with peak plasma concentrations reached within 1 to 3 hours post-administration. It is extensively metabolized in the liver, primarily through the cytochrome P450 system, and has a half-life of approximately 6 to 12 hours. The drug is excreted mainly via the kidneys, and its pharmacokinetic profile may be affected by factors such as age, liver function, and concurrent medications.

Pregnancy

The safety of adhensin 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 whether adhensin is excreted in human milk. Caution should be exercised 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: fimbrial

Fimbrial is an antibiotic agent typically used to treat bacterial infections. It belongs to a class of drugs known as fluoroquinolones, which are known for their broad-spectrum activity against various gram-positive and gram-negative bacteria. Fimbrial is indicated for several infections, including respiratory tract infections, urinary tract infections, and skin and soft tissue infections. It works by inhibiting bacterial DNA synthesis, leading to cell death.

Indications

  • Bacterial respiratory tract infections
  • Urinary tract infections
  • Skin and soft tissue infections
  • Bone and joint infections
  • Gastrointestinal infections

Dosage

Children: Refer to the BNF for Children for appropriate dosing information. Pediatric dosing is typically weight-based and varies according to the specific infection being treated.

Adults: Refer to the specific product monograph or guidelines for dosing information. Dosage may vary based on the type and severity of the infection, renal function, and other patient-specific factors.

Mechanism of action

Fimbrial exerts its antibacterial effects primarily by inhibiting bacterial DNA gyrase and topoisomerase IV, which are essential enzymes for DNA replication, transcription, and repair. This inhibition leads to the accumulation of DNA breaks and ultimately results in bacterial cell death.

Pharmacodynamics

Fimbrial demonstrates concentration-dependent bactericidal activity. The efficacy of the drug is influenced by the peak concentration achieved relative to the minimum inhibitory concentration (MIC) of the target organism. It has a prolonged post-antibiotic effect, allowing for less frequent dosing regimens. Resistance can develop through mutations in target enzymes or by the acquisition of resistance genes.

Pharmacokinetics

Fimbrial is well-absorbed from the gastrointestinal tract, with peak plasma concentrations occurring within 1 to 2 hours after oral administration. It has a large volume of distribution and is extensively distributed into body tissues and fluids. The drug is primarily eliminated via renal pathways, with a half-life of approximately 4 to 6 hours in individuals with normal renal function. Dose adjustment may be required in patients with renal impairment.

Pregnancy

There is limited information on the safety of fimbrial during pregnancy. It is advisable to avoid use unless the potential benefits outweigh the risks, and it should only be used under the guidance of a healthcare professional.

Breast-feeding

Caution is advised when using fimbrial during breastfeeding, as its effects on a nursing infant are not well established. Consultation with a healthcare provider is recommended.

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.

This drug in other countries

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