Registered Tanzania · TMDA

Cervarix Vaccine

3 - O - deacyl- 4- monophosphoryl lipid A 50 mcg/ml,Aluminium Hydroxide 0.5 mg,Human Papillomavirus type 16 L1 Protein 20 µg/0.5 ml,Human Papillomavirus type 18 L1 Protein 20 µg/0.5 ml

TAN 08,160 J07A GSK Suspension for injection

What it does

Aluminium is a substance often used in various medical applications, particularly in certain types of medications.

Commonly used for: heartburn (dyspepsia), stomach upset, acid indigestion

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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.
TAN 08,160 J07A GSK
Registration date
2024-06-02
Expiry date
2029-06-01
Status
Registered/Compliant
Active ingredient
3 - O - deacyl- 4- monophosphoryl lipid A 50 mcg/ml,Aluminium Hydroxide 0.5 mg,Human Papillomavirus type 16 L1 Protein 20 µg/0.5 ml,Human Papillomavirus type 18 L1 Protein 20 µg/0.5 ml
Strength
-
Pack size
-
Therapeutic class
-
RxNorm RxCUI
1311504
Manufacturer / MAH
GlaxoSmithKline
Applicant / LTR
GSK Biologicals SA
Country of origin
BELGIUM
Manufacturer location
Rue de l'Institut 89, 1330 Rixensart, Belgium

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:51:09 · updated 2026-09-24 03:00:47

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

About aluminium

Aluminium is a substance often used in various medical applications, particularly in certain types of medications.

What it treats

  • heartburn (dyspepsia)
  • stomach upset
  • acid indigestion

How it works

Aluminium works by neutralizing stomach acid, which helps to relieve discomfort from acid-related conditions.

Who it's for

This is suitable for adults and children who experience symptoms related to excess stomach acid.

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

About human

Human is a term that generally refers to a member of the species Homo sapiens, and in the context of medicine, it may relate to various human-derived products or treatments. However, there are no specific drug class, interactions, or cautions provided for this entry.

How it works

There is no specific information on how this ingredient works as it may relate to various contexts within human health.

Who it's for

Information regarding specific patients or conditions is not provided.

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

About hydroxide

Hydroxide is a compound used to help neutralize stomach acid and relieve indigestion or heartburn.

What it treats

  • indigestion
  • heartburn

How it works

Hydroxide works by neutralizing the excess acid in the stomach, which helps to reduce discomfort.

Who it's for

Hydroxide is suitable for adults and children experiencing symptoms of excess stomach acid.

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

About lipid

Lipids are fats that are important for energy storage and overall health.

What it treats

  • providing energy to the body
  • supporting cell function
  • aiding in the absorption of vitamins

How it works

Lipids store energy and help in the structure of cell membranes, as well as playing a role in hormone production.

Who it's for

Lipids are essential for everyone, as they are a vital part of a balanced diet.

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

About monophosphoryl

Monophosphoryl is a compound that may be used in certain treatments to help the body respond better to infections and diseases.

What it treats

  • improving immune response
  • supporting treatment of infections

How it works

It helps the immune system fight infections more effectively.

Who it's for

It is generally used for people needing enhanced immune support.

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

About papillomavirus

Papillomavirus is a virus that can cause warts and certain types of cancer, primarily affecting the skin and genital areas.

What it treats

  • warts
  • genital warts
  • cervical cancer prevention

How it works

Vaccines can help protect against certain strains of papillomavirus, reducing the risk of infections and related conditions.

Who it's for

It is used for individuals, especially young people, to prevent infections and related complications from papillomavirus.

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

About protein

Protein is an essential nutrient that helps build and repair tissues in the body.

What it treats

  • malnutrition
  • muscle weakness
  • wound healing

How it works

Protein provides the building blocks (amino acids) that the body needs to create and maintain muscles, skin, and other tissues.

Who it's for

It is suitable for anyone who needs to increase their protein intake, including those recovering from illness or injury, athletes, and people with certain dietary restrictions.

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

Clinical monograph: aluminium

BNF-referenced

Aluminum, commonly used as an antacid, primarily functions to neutralize stomach acid and alleviate symptoms of dyspepsia, such as heartburn and indigestion. Its astringent properties allow it to constrict tissues, which can aid in the treatment of various gastrointestinal conditions. Aluminum salts, particularly aluminum hydroxide, are widely used in clinical practice.

Indications

  • Dyspepsia
  • Peptic ulcer disease
  • Gastroesophageal reflux disease (GERD)
  • Heartburn
  • Diarrhea
  • Mucosal irritations

Dosage

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

Adults: Refer to the BNF for specific dosing recommendations based on the condition being treated.

Mechanism of action

Aluminum acts as an astringent, causing local shrinkage or constriction of body tissues through osmotic flow of fluids away from the area of application. This mechanism assists in reducing mucous secretions and managing conditions such as peptic ulcers and diarrhea. Additionally, it can help in drying and hardening of tissues when applied topically.

Pharmacodynamics

Aluminum-based antacids work by neutralizing gastric acid, leading to an increase in gastric pH. This action helps to alleviate symptoms associated with excess gastric acid, such as heartburn and discomfort. The astringent properties of aluminum also contribute to its therapeutic effects in managing mucosal irritations and secretions.

Pharmacokinetics

Aluminum is absorbed minimally when taken orally, with a bioavailability of about 0.1 to 0.5%. The majority of aluminum is excreted renally, and its half-life can be prolonged in individuals with renal impairment. Long-term use may lead to accumulation and potential toxicity, particularly impacting bone and neurological health.

Interactions

  • aluminiumhydroxide+deferasirox: Severe (decreases exposure)
  • aluminiumhydroxide+enteralfeeds: Unknown (increases risk of blocked enteral or nasogastric tubes)
  • aluminiumhydroxide+roxadustat: Unknown (decreases exposure)

Pregnancy

Aluminum compounds are generally considered safe in pregnancy when used as directed. However, excessive exposure should be avoided.

Breast-feeding

Aluminum is excreted in breast milk; caution is advised when administered to nursing mothers.

Storage

Store in a cool, dry place, away from direct sunlight.

Formulations

  • aluminium hydroxide suspension
  • aluminium hydroxide tablets

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: human

Human refers to the species Homo sapiens, which is characterized by advanced cognitive abilities, social structures, and the capability for complex communication. The term may also refer to human-derived biological products, such as blood, tissues, or organs used in medical treatments and research.

Dosage

Children: Dosage for human-derived biological products in pediatrics should be determined based on specific product guidelines and the clinical context.

Adults: Dosage for human-derived biological products varies widely. Refer to specific product information for appropriate dosing.

Mechanism of action

Human physiology is governed by complex biological systems involving various cellular and molecular pathways. The mechanisms of action for human-derived biological products vary widely depending on the specific context, including immune response, hormonal regulation, and metabolic processes.

Pharmacodynamics

Pharmacodynamics in humans involves the interaction of drugs with biological systems, resulting in therapeutic effects. This includes receptor binding, signal transduction, and physiological responses. The effects are influenced by genetic factors, existing health conditions, and concurrent medications.

Pharmacokinetics

Pharmacokinetics in humans involves the absorption, distribution, metabolism, and excretion (ADME) of substances. Factors such as age, sex, body weight, and organ function can significantly influence these processes. Drug absorption may occur via oral, intravenous, or other routes, while distribution depends on blood flow and tissue permeability. Metabolism typically occurs in the liver, and excretion primarily takes place through the kidneys.

Pregnancy

There is no specific information available; consult local guidelines.

Breast-feeding

There is no specific information available; consult local guidelines.

Storage

Store in a cool, dry place away from direct sunlight.

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: hydroxide

BNF-referenced

Hydroxide, represented by the molecular formula HO-, is an anion commonly found in various chemical and biological systems. It plays a crucial role in acid-base chemistry and is a fundamental component in many biochemical pathways. Hydroxide ions are involved in maintaining pH balance in biological systems and participate in various metabolic processes.

Dosage

Children: Refer to specific guidelines for pediatric dosing; consult the BNF for Children for accurate dosage information.

Adults: Refer to specific guidelines for use; dosage may vary based on the context of use.

Mechanism of action

Hydroxide ions act primarily as bases, neutralizing acids to form water and salts. They participate in various biochemical pathways, including selenium metabolism and the degradation of reactive oxygen species. Hydroxide can influence enzyme activity and stability by altering the pH of the environment, thereby affecting metabolic reactions.

Pharmacodynamics

Hydroxide ions can impact biological processes by changing the local pH, which influences enzyme activity, ion transport, and the solubility of other compounds. Their ability to neutralize acids can help regulate physiological pH, contributing to homeostasis in living organisms.

Pharmacokinetics

As an inorganic ion, hydroxide does not undergo traditional pharmacokinetic processes like absorption, distribution, metabolism, or excretion. Instead, it is rapidly equilibrated in biological fluids and participates in acid-base reactions, having immediate effects on the local environment.

Pregnancy

There is limited information regarding the use of hydroxide during pregnancy. Consult a healthcare professional for advice.

Breast-feeding

Limited data is available on the excretion of hydroxide in breast milk. Consult 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: lipid

Lipids are a diverse group of hydrophobic organic compounds, including fats, oils, waxes, and steroids, that play crucial roles in biological systems. They are essential components of cell membranes, serve as energy storage molecules, and are involved in signaling pathways. Lipids can be classified into several categories, including triglycerides, phospholipids, and cholesterol, each with distinct functions in metabolism and cellular structure.

Indications

  • Hyperlipidemia
  • Atherosclerosis
  • Pancreatitis
  • Fatty liver disease
  • Obesity
  • Cardiovascular disease

Dosage

Children: Refer to paediatric guidelines for dosing; specific dosages depend on the lipid-lowering medication used and the child's condition.

Adults: Refer to specific treatment guidelines for dosing based on the type of lipid-lowering therapy or condition being addressed.

Mechanism of action

Lipids perform various roles depending on their type. Triglycerides provide energy through oxidation; phospholipids form bilayers that make up cellular membranes, facilitating membrane fluidity and the function of membrane proteins. Cholesterol stabilizes cell membranes and is a precursor for steroid hormones, bile acids, and vitamin D. Lipid signaling molecules, such as eicosanoids, are derived from polyunsaturated fatty acids and play pivotal roles in inflammation and immune responses.

Pharmacodynamics

Lipids influence numerous physiological processes, including energy metabolism, cell membrane integrity, and the synthesis of bioactive molecules. They modulate enzyme activity, hormone production, and gene expression. The balance of different lipid types is crucial for maintaining cellular functions and overall health.

Pharmacokinetics

Lipids are absorbed in the gastrointestinal tract and transported in the bloodstream primarily as lipoproteins. They undergo processes of hydrolysis by lipases to yield free fatty acids and glycerol, which can be utilized for energy or re-esterified for storage. The metabolism of lipids occurs in the liver, where they can be synthesized or converted into other metabolites. The elimination of lipid metabolism products primarily occurs through the liver and kidneys.

Contra-indications

  • Hypersensitivity to any component of the formulation
  • Severe liver disease
  • Active pancreatitis

Adverse effects

  • Nausea
  • Diarrhea
  • Abdominal pain
  • Dyspepsia
  • Elevated liver enzymes
  • Rash
  • Myopathy or rhabdomyolysis (particularly with certain lipid-lowering agents)

Interactions

  • Certain anticoagulants may have altered effects
  • Caution with other medications that can affect liver function
  • Some drugs may increase the risk of myopathy when used in combination

Precautions

  • Monitor liver function tests regularly during therapy
  • Consider potential drug-drug interactions before initiating therapy
  • Use with caution in patients with a history of muscle disorders

Pregnancy

Lipid-lowering therapies are generally avoided during pregnancy due to potential risks to the fetus. Consult relevant guidelines for specifics.

Breast-feeding

Caution is advised, as some lipid-lowering agents may pass into breast milk. Consult healthcare professionals for specific recommendations.

Storage

Store in a cool, dry place away from light. Keep out of reach of children.

Formulations

  • Oral tablets
  • Capsules
  • Injectable forms (for certain lipid 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: monophosphoryl

Monophosphoryl is a derivative of lipopolysaccharide (LPS) that is designed to elicit a weaker immune response compared to native LPS. It is primarily studied for its potential use as an adjuvant in vaccines and for enhancing immune responses in various therapeutic contexts. By modifying the structure of LPS, monophosphoryl aims to maintain its immunogenic properties while reducing the adverse effects associated with the full molecule.

Indications

  • Vaccine adjuvant
  • Immunotherapy
  • Enhancement of immune response

Dosage

Children: Refer to specific product guidelines for dosing in children, as pediatric doses are often adjusted based on age and weight.

Adults: Refer to specific product guidelines for dosing in adults, as dosages may vary depending on the formulation and intended use.

Mechanism of action

Monophosphoryl functions as an immunomodulator by interacting with Toll-like receptor 4 (TLR4) on immune cells. This interaction activates signaling pathways that lead to the production of pro-inflammatory cytokines, although to a lesser extent than native LPS. The modified structure of monophosphoryl reduces the overstimulation of the immune system, making it a safer alternative in vaccine formulations.

Pharmacodynamics

The pharmacodynamics of monophosphoryl involves its role as a TLR4 agonist, which triggers a cascade of immune responses. This results in the activation of antigen-presenting cells, enhanced T-cell activation, and the generation of a more robust immune memory. The balance it strikes between immune activation and safety makes it particularly interesting for therapeutic applications.

Pharmacokinetics

The pharmacokinetics of monophosphoryl are not extensively studied, but it is expected to be absorbed following administration, with bioavailability influenced by the route of administration. Once in circulation, it likely undergoes metabolism through immune-mediated processes, with a gradual clearance from the body. Its half-life and exact metabolic pathways remain to be fully elucidated.

Pregnancy

Safety in pregnancy has not been established. Use only if clearly needed and the potential benefits justify the risks to the fetus.

Breast-feeding

It is not known whether monophosphoryl is excreted in human breast milk. Caution is advised when administering to nursing mothers.

Storage

Store in a cool, dry place away from light. Ensure the container is tightly closed.

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: papillomavirus

Papillomavirus, particularly human papillomavirus (HPV), is a group of more than 200 related viruses, some of which can cause benign warts, while others are associated with various cancers, including cervical cancer, anal cancer, and oropharyngeal cancer. HPV is transmitted through direct skin-to-skin contact, and certain strains are classified as high-risk for cancer development. Vaccination against HPV has been developed to prevent infections, thereby reducing the incidence of these related cancers.

Indications

  • Prevention of cervical cancer
  • Prevention of anal cancer
  • Prevention of oropharyngeal cancer
  • Prevention of genital warts

Dosage

Children: Refer to relevant guidelines for vaccination schedules and administration.

Adults: Refer to relevant guidelines for vaccination schedules and administration.

Mechanism of action

HPV infects epithelial cells and integrates its DNA into the host cell genome. The viral proteins E6 and E7 interfere with host cell cycle regulation, inhibiting tumor suppressor proteins p53 and retinoblastoma (Rb). This leads to uncontrolled cell proliferation and genomic instability, contributing to oncogenesis.

Pharmacodynamics

The immune response to HPV infection can lead to the elimination of the virus in some individuals, while others may develop persistent infections that can progress to dysplasia and cancer. The effectiveness of HPV vaccines is based on their ability to elicit a strong and lasting immune response against the virus, thus preventing the associated diseases.

Pharmacokinetics

HPV is not treated with conventional pharmacological agents, as it is a viral infection that requires preventive measures such as vaccination. The HPV vaccines are administered intramuscularly, leading to systemic circulation of the vaccine components, which stimulate an immune response. The half-life of antibodies generated in response to the vaccine is variable but generally lasts for several years, providing long-term protection.

Adverse effects

  • Local reactions at the injection site
  • Fever
  • Headache
  • Fatigue
  • Nausea

Precautions

  • Caution in patients with a history of allergic reactions to vaccine components
  • Consider the risk of fainting after vaccination
  • Monitor for any adverse reactions post-vaccination

Pregnancy

The safety of papillomavirus vaccines during pregnancy has not been established. Vaccination is generally not recommended during pregnancy unless the benefits outweigh the risks.

Breast-feeding

There is no evidence suggesting that papillomavirus vaccines pose a risk to breastfeeding infants. Vaccination can be considered.

Storage

Store in a refrigerator at 2 to 8 degrees Celsius. Do not freeze. Protect from light.

Formulations

  • Quadrivalent HPV vaccine (types 6, 11, 16, 18)
  • Bivalent HPV vaccine (types 16, 18)
  • Nonavalent HPV vaccine (types 6, 11, 16, 18, 31, 33, 45, 52, 58)

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: protein

Proteins are large, complex molecules made up of amino acids and are essential for the structure, function, and regulation of the body's tissues and organs. They play critical roles in various biological processes, including enzymatic reactions, immune responses, and cellular signaling. Dietary proteins are obtained from both animal and plant sources and are broken down into amino acids during digestion, which are then used by the body to synthesize new proteins as needed.

Indications

  • Nutritional supplementation
  • Muscle repair and growth
  • Immune support
  • Enzyme replacement therapy
  • Hormonal regulation

Dosage

Children: Refer to specific product guidelines for dosing information, as protein requirements in children vary based on age, growth stage, and health status.

Adults: Refer to specific product guidelines for dosing information, as protein requirements can vary widely based on individual needs, activity levels, and clinical conditions.

Mechanism of action

Proteins exert their effects primarily through their structure and interactions with other molecules. They can function as enzymes, hormones, and antibodies, and their action is often mediated by binding to specific receptors or substrates, leading to a change in cellular activity or function. For example, enzymes catalyze biochemical reactions, while antibodies bind to antigens to facilitate immune responses.

Pharmacodynamics

The pharmacodynamics of proteins can vary significantly depending on the specific protein being considered. Generally, the effects of proteins are dose-dependent and influenced by their concentration, affinity for targets, and duration of action. Proteins can have a wide range of biological activities, including promoting cellular repair, regulating metabolism, and modulating immune responses.

Pharmacokinetics

The pharmacokinetics of proteins includes their absorption, distribution, metabolism, and excretion (ADME). Proteins are typically digested in the gastrointestinal tract into amino acids before being absorbed into the bloodstream. Once in circulation, proteins can be distributed throughout various tissues. They may have a variable half-life based on their structure and function, and they are primarily metabolized by the liver and excreted via the kidneys. The pharmacokinetic profile can be influenced by factors such as the route of administration and the presence of other substances.

Pregnancy

Generally considered safe, but high protein intake should be monitored to avoid potential risks.

Breast-feeding

Adequate protein intake is critical for lactating women to support milk production and quality.

Storage

Store in a cool, dry place, away from direct sunlight.

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: aluminium

PubChem CID 5359268

Molecular formula: Al

Mechanism of action

Aluminum Acetate is an astringent. An astrignent is a chemical that tends to shrink or constrict body tissues, usually locally after topical medicinal application. The shrinkage or constriction is through osmotic flow of water (or other fluids) away from the area where the astringent was applied. Astringent medicines cause shrinkage of mucous membranes or exposed tissues and are often used internally to check discharge of blood serum or mucous secretions. This can happen with a sore throat, hemorrhages, diarrhea, or with peptic ulcers. Externally applied astringents, which cause mild coagulation of skin proteins, dry, harden, and protect the skin. Acne sufferers are often advised to use astringents if they have oily skin. Astringents also help heal stretch marks and other scars. Mild astringent solutions are used in the relief of such minor skin irritations as those resulting from superficial cuts, allergies, insect bites, or fungal infections such as athlete's foot. Excessive dietary aluminum has been proposed to be a factor contributing to several neurological disorders in humans. Six 8-week-old female Swiss Webster mice were fed for 10 wk purified diets containing 100 (control), 500 or 1000 ug aluminum/g diet. Brain and liver lipid peroxidation was determined by evaluating the production of 2-thiobarbituric acid reactive substances in brain and liver homogenates in the presence or absence of 50 uM ferrous iron. 2-Thiobarbituric acid reactive substances production in the absence of iron in brain homogenates from mice fed the 1000 ug/g diet was higher (30%) than that in the 100 ug/g control group (3.1 vs 2.4 nmol 2-thiobarbituric acid reactive substances/mg protein). The addition of ferrous iron increased 2-thiobarbituric acid reactive substances production in brain homogenates from all 3 dietary groups. The iron induced 2-thiobarbituric acid reactive substances production was 26% higher in the 1000 ug/g brain homogenates than in the 100 ug/g group (4.9 vs 3.9 nmol 2-thiobarbituric acid reactive substances/mg protein). Brain 2-thiobarbituric acid reactive substances production in the presence and absence of iron was similar between the 100 and 500 ug/g aluminum groups. 2-Thiobarbituric acid reactive substances production in liver homogenates measured either with or without iron was similar for the 3 groups. These results show that, in mice, dietary aluminum intoxication leads to increased brain 2-thiobarbituric acid reactive substance production, suggesting that enhanced lipid peroxidation may be one possible mechanism underlying the neurological damage associated with increased tissue aluminum. Evidence is presented indicating that dementias are associated with a relative insufficiency of magnesium in the brain. Such insufficiency may be attributable to low intake or retention of magnesium; high intake of a neurotoxic metal, such as aluminum, which inhibits activity of magnesium requiring enzymes; or impaired transport of magnesium and/or enhanced transport of the neurotoxic metal into brain tissue. It is proposed that Alzheimer's disease involves a defective transport process, characterized by both an abnormally high incorporation of aluminum and an abnormally low incorporation that an altered serum protein contributes to the progression of Alzheimer's disease by having a greater affinity for aluminum than for magnesium, in contrast to the normal protein, which binds magnesium better than aluminum. The altered protein crosses the blood-brain barrier more efficiently than the normal protein and competes with the normal protein in binding to brain neurons. Binding of the altered protein to the target neurons would both facilitate aluminum uptake and impede magnesium uptake. Evidence suggests that albumin is the serum protein that is altered. Aluminum is established as a neurotoxin, although the basis for its toxicity is unknown. It recently has been shown to alter the function of the blood-brain barrier, which regulates ex

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

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