International reference: 4 US FDA recalls for this ingredient

Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets. (fragments)

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. (fragments)

Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter. (fragments)

Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh. (fragments)

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

Registered Kenya · PPB

TETANEA 1500/ML EQUINE TETANUS IMMUNOGLOBULIN F(AB���)2 FRAGMENTS

EQUINE TETANUS IMMUNOGLOBULIN F(AB���)2 FRAGMENTS

What it does

Equine is a medication derived from horse sources, often used in specific treatments.

Commonly used for: certain blood disorders, specific immune system conditions

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.

Hard to find? We help patients in Kenya source rare medicines. We don't sell or dispense medicines - licensed pharmacies do.

Source this medicine

Registration & product details

Registration no.
3227
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
EQUINE TETANUS IMMUNOGLOBULIN F(AB���)2 FRAGMENTS
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Sanofi Aventis
Applicant / LTR
-
Country of origin
FOREIGN
Manufacturer location
Crowne Plaza Hotel Annex, 13th Floor Longonot Rd, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 21:14:19 · updated 2026-07-20 08:57:29

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About equine

Equine is a medication derived from horse sources, often used in specific treatments.

What it treats

  • certain blood disorders
  • specific immune system conditions

How it works

It helps the body manage certain health issues by providing necessary components that may be lacking.

Who it's for

This medication is typically for patients with specific medical conditions that require equine-derived treatment.

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

About fragments

Fragments are a type of medicine that can be used in various treatments.

How it works

Fragments work by targeting specific areas in the body to help manage certain conditions.

Who it's for

Fragments are prescribed for patients who need treatment for specific health issues.

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

About immunoglobulin

Immunoglobulin is a treatment that helps boost the immune system by providing antibodies. It is often used to help people with weakened immune systems.

What it treats

  • weakened immune system
  • certain autoimmune diseases
  • infections

How it works

Immunoglobulin provides antibodies to the body, which help fight off infections and support the immune response.

Who it's for

This treatment is suitable for individuals with conditions that cause a low level of antibodies or those who have autoimmune disorders.

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

About tetanus

Tetanus is a serious bacterial infection that affects the nervous system and can cause muscle stiffness and spasms.

What it treats

  • tetanus infection
  • lockjaw

How it works

Tetanus is caused by a toxin produced by the bacteria Clostridium tetani, which interferes with nerve signals to muscles.

Who it's for

Tetanus can affect anyone, especially those who are not vaccinated or have not received booster shots.

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

Clinical monograph: equine

Equine therapy, often referred to as equine-assisted therapy or horseback riding therapy, involves the use of horses as a means of facilitating therapeutic outcomes for various physical, emotional, and psychological conditions. It is used in rehabilitation settings, for children with developmental disorders, and in mental health therapy. The interaction with horses can improve balance, coordination, and emotional well-being, while also providing a unique opportunity for patients to engage in physical activity.

Indications

  • Autism Spectrum Disorders
  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Post-Traumatic Stress Disorder (PTSD)
  • Anxiety Disorders
  • Depression
  • Cerebral Palsy
  • Physical Rehabilitation

Dosage

Children: Refer to the specific therapeutic regimen determined by a healthcare professional, as equine therapy is individualized based on patient needs.

Adults: Refer to the specific therapeutic regimen determined by a healthcare professional, as equine therapy is individualized based on patient needs.

Mechanism of action

Equine therapy operates on several levels. The physical interaction with horses can enhance gross motor skills and encourage physical fitness. Psychologically, the bond formed between horse and human can foster emotional healing, reduce anxiety, and build confidence. The rhythmic motion of riding has been shown to have a calming effect on individuals, mimicking similar movements to those experienced in a therapeutic setting. Moreover, the social interaction involved in caring for and riding horses may improve communication skills and socialization.

Pharmacodynamics

Equine therapy itself does not involve pharmacological agents; however, it may influence the psychobiological pathways in the body. The interactions evoke hormonal responses that can alter levels of cortisol and adrenaline, enhancing relaxation and reducing stress. The therapeutic environment can also promote the release of endorphins, contributing to a sense of well-being and happiness.

Pharmacokinetics

As equine therapy does not involve drugs, pharmacokinetics is not applicable. However, the effects on the body can vary based on individual patient characteristics, the specific condition treated, and the duration and frequency of the therapy sessions. Factors such as age, physical condition, and psychological state can influence therapeutic outcomes.

Pregnancy

Equine products should be used with caution during pregnancy, as there is limited data on their safety. Consultation with a healthcare professional is recommended.

Breast-feeding

Safety during breastfeeding is not well established; therefore, caution is advised when using equine products in nursing mothers.

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: fragments

Fragments, often referred to as peptide fragments or protein fragments, are smaller sections of proteins that can exert biological effects. These fragments can be derived from larger proteins through various methods such as enzymatic cleavage or chemical synthesis. They are involved in numerous physiological processes and can serve various roles in therapeutic applications, particularly in the fields of immunology, oncology, and regenerative medicine.

Indications

  • Cancer therapy
  • Immunotherapy
  • Wound healing
  • Hormonal therapies
  • Metabolic disorders

Dosage

Children: Dosing for paediatric patients is dependent on the specific fragment and indication; consult pediatric dosing references or clinical guidelines for appropriate dosing.

Adults: Dosing for fragments varies widely based on the specific type and use case; refer to specific product information or clinical guidelines for accurate dosing.

Mechanism of action

The mechanism of action of fragments varies widely depending on the specific fragment in question. Generally, peptide fragments can interact with specific receptors on cell surfaces, modulating signaling pathways and biological responses. For example, some fragments may act as agonists or antagonists at hormone receptors, influencing processes such as metabolism, growth, and immune responses. Additionally, fragments can enhance or inhibit protein-protein interactions, affecting cellular activities.

Pharmacodynamics

Pharmacodynamics of fragments is largely dependent on their structure and the biological targets they engage. Fragments may exhibit dose-dependent effects, and their potency can be influenced by factors such as their affinity for receptors, their ability to penetrate cellular membranes, and their stability in biological systems. The biological activity can range from promoting cellular proliferation and differentiation to inducing apoptosis in cancer cells.

Pharmacokinetics

The pharmacokinetics of fragments can vary considerably. Generally, they may have a shorter half-life compared to full-length proteins due to their smaller size and potential for faster metabolism. Absorption can occur via various routes, including oral, subcutaneous, or intravenous administration, depending on the formulation. Distribution is influenced by their hydrophilicity or lipophilicity, while elimination typically involves renal clearance or degradation by proteolytic enzymes.

Pregnancy

Safety in pregnancy has not been established. Use only if clearly needed.

Breast-feeding

Caution is advised. It is recommended to consult with a healthcare professional before use.

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: immunoglobulin

Immunoglobulin is a preparation of antibodies derived from human plasma, used for passive immunization and to modulate immune responses. It is composed of a mixture of immunoglobulin G (IgG) antibodies and is administered to prevent infections in immunocompromised patients, treat various autoimmune disorders, and manage conditions like chronic inflammatory demyelinating polyneuropathy (CIDP).

Indications

  • Primary immunodeficiency disorders
  • Secondary immunodeficiency (e.g. due to HIV infection)
  • Chronic inflammatory demyelinating polyneuropathy (CIDP)
  • Immune thrombocytopenic purpura (ITP)
  • Kawasaki disease
  • Prevention of infections in at-risk populations (e.g. following bone marrow transplant)

Dosage

Children: Refer to the BNF for Children for age-appropriate dosing guidelines; specific doses depend on the clinical condition and patient age.

Adults: Refer to specific guidelines for dosing based on indication; typically varies based on clinical scenario and patient condition.

Mechanism of action

Immunoglobulin exerts its effects primarily through the neutralization of pathogens and toxins, opsonization, and the activation of the complement system. It modulates immune responses by influencing the activity of various immune cells, including B cells, T cells, and macrophages, thereby enhancing antibody production and regulating inflammation.

Pharmacodynamics

The pharmacodynamics of immunoglobulin involve its ability to bind to specific antigens, effectively neutralizing them and facilitating their clearance. It also plays a crucial role in modulating the immune response, providing immediate passive immunity and promoting the establishment of active immunity over time. The diverse mechanisms through which immunoglobulin operates include antibody-dependent cell-mediated cytotoxicity (ADCC) and inhibition of pro-inflammatory cytokines.

Pharmacokinetics

Immunoglobulin is typically administered intravenously or subcutaneously. After administration, it is distributed throughout the extracellular space. The half-life of immunoglobulin varies but is generally in the range of 21 to 30 days, depending on the specific formulation and the patient's individual characteristics. It is primarily eliminated through the reticuloendothelial system, with catabolism occurring in various tissues.

Contra-indications

  • Hypersensitivity to immunoglobulin preparations
  • Selective IgA deficiency with a history of hypersensitivity
  • Severe hyperprolinemia

Adverse effects

  • Headache
  • Nausea
  • Fever
  • Chills
  • Fatigue
  • Rash
  • Anaphylactic reactions
  • Thromboembolic events

Interactions

  • Live attenuated vaccines may be less effective if administered concurrently with immunoglobulin therapy
  • Caution is advised when administering with other blood products

Precautions

  • Monitor for signs of anaphylaxis during and after administration
  • Use with caution in patients with renal impairment
  • Hydrate adequately to prevent renal dysfunction
  • Consider the risk of thrombosis in patients with a history of thromboembolic events

Pregnancy

Immunoglobulin can be used during pregnancy if indicated, as it is considered safe based on available data.

Breast-feeding

Immunoglobulin is excreted in breast milk, but is generally considered safe during breastfeeding.

Storage

Store at 2-8 degrees Celsius. Do not freeze. Protect from light. Use before expiry date.

Formulations

  • Intravenous immunoglobulin (IVIG)
  • Subcutaneous immunoglobulin (SCIG)
  • Intramuscular immunoglobulin (IMIG)

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: tetanus

Tetanus is a serious bacterial infection caused by the bacterium Clostridium tetani, which produces a potent toxin affecting the nervous system. The disease is characterized by muscle stiffness and spasms, often beginning in the jaw and neck. It can lead to severe complications and can be fatal if left untreated. Vaccination is the primary method of prevention, and treatment typically involves antitoxins, antibiotics, and supportive care.

Indications

  • Tetanus prophylaxis
  • Treatment of tetanus infection
  • Management of tetanus symptoms

Dosage

Children: Refer to the specific guidelines for tetanus immunoglobulin and other supportive treatments as per clinical protocols.

Adults: Refer to the specific guidelines for tetanus immunoglobulin and other supportive treatments as per clinical protocols.

Mechanism of action

The tetanus toxin binds to the presynaptic membrane of motor neurons and is transported retrogradely to the spinal cord, where it interferes with neurotransmitter release, particularly inhibiting the release of glycine and gamma-aminobutyric acid (GABA), leading to unopposed motor neuron activity and resultant muscle rigidity and spasms.

Pharmacodynamics

Tetanus toxin is one of the most potent toxins known, with effects that can manifest within hours of exposure. The toxin's ability to block inhibitory neurotransmitter release results in a state of continuous muscle contraction, known as tetany. The clinical presentation of tetanus includes trismus (lockjaw), muscle rigidity, and autonomic instability, among others.

Pharmacokinetics

The pharmacokinetics of tetanus toxin are complex due to its high potency and the nature of its action. Following entry into the body, the toxin binds to nerve endings and is internalized, leading to its effects on neurotransmitter release. The half-life of the toxin is not well defined as it does not circulate freely in the bloodstream but acts locally at the neuromuscular junction. Recovery from the effects of the toxin may take weeks to months, depending on the severity of the infection and the treatment provided.

Adverse effects

  • Pain at the injection site
  • Fever
  • Fatigue
  • Headache
  • Nausea

Precautions

  • Ensure patient is up to date with vaccinations
  • Monitor for allergic reactions post-vaccination
  • Consider history of neurological disorders

Pregnancy

Tetanus vaccination is considered safe during pregnancy and is recommended to protect both the mother and the newborn.

Breast-feeding

Tetanus vaccination is safe during breastfeeding and does not affect the nursing infant.

Storage

Store in a refrigerator at 2–8 degrees Celsius. Do not freeze.

Formulations

  • Tetanus toxoid vaccine

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.