Indirab Rabies Vaccine BP + Diluent for Indirab Injection

Indications

• Hypoalbuminemia
• Volume resuscitation in shock
• Liver cirrhosis
• Nephrotic syndrome
• Burns
• Postoperative fluid management

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations based on clinical condition and patient response.

Adults: Refer to the appropriate guidelines for specific dosing recommendations based on clinical condition and patient response.

Mechanism of action

Albumin acts by maintaining oncotic pressure in the vascular system, thus preventing fluid from leaking into tissues and promoting the return of interstitial fluid to the bloodstream. This action helps restore blood volume and improve circulation in patients with conditions that lead to hypovolemia or edema. Additionally, albumin can bind and transport various endogenous and exogenous substances, influencing their distribution and elimination.

Pharmacodynamics

The primary pharmacodynamic effect of albumin is the increase in plasma oncotic pressure, which helps to retain fluid within the vascular space. This effect is critical in managing conditions associated with fluid imbalance. Albumin also has antioxidant properties and may play a role in modulating inflammatory responses, although these effects are secondary to its role in volume expansion.

Pharmacokinetics

Albumin is administered intravenously, where it is distributed rapidly throughout the vascular compartment. The half-life of albumin in circulation is typically around 15 to 20 days, depending on physiological conditions. It is metabolized primarily in the liver, with a small percentage undergoing renal clearance. The distribution volume is influenced by factors such as hydration status and the presence of diseases affecting protein levels.

Contra-indications

• Severe anemia
• Congestive heart failure
• Pulmonary edema
• Severe dehydration
• Allergy to albumin or any component of the formulation

Adverse effects

• Allergic reactions including anaphylaxis
• Headache
• Nausea
• Vomiting
• Fever
• Hypotension
• Fluid overload

Interactions

• Caution should be exercised when administering with other fluids or medications that may affect fluid balance
• May alter the pharmacokinetics of certain drugs due to changes in plasma volume

Precautions

• Monitor for signs of fluid overload, especially in patients with heart or kidney disease
• Use cautiously in patients with a history of allergic reactions
• Ensure proper storage and handling to avoid contamination

Pregnancy

Albumin is generally considered safe during pregnancy when administered for appropriate indications, but its use should be assessed on a case-by-case basis.

Breast-feeding

Albumin can be used during breastfeeding, as it is a naturally occurring protein in human milk.

Storage

Store at 2 to 8 degrees Celsius. Do not freeze. Protect from light and use within the expiry date.

Formulations

• Human albumin solution (various concentrations)
• Albumin (500 mL bags, 20% and 5% solutions)

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.

Indications

• Energy source in metabolic disorders
• Component in nutritional supplements
• Used in food and beverage applications

Dosage

Children: Refer to specific product guidelines or dietary recommendations for paediatric use.

Adults: Refer to specific product guidelines or dietary recommendations for adult use.

Mechanism of action

Maltose is metabolized by enzymes such as maltase, which hydrolyzes maltose into two glucose molecules. These glucose molecules are then utilized in glycolysis and other metabolic pathways to produce energy. Maltose also participates in various biological processes, including trehalose biosynthesis and starch degradation.

Pharmacodynamics

Maltose is rapidly broken down into glucose, leading to an increase in blood glucose levels. This can provide a quick source of energy, making it beneficial in situations where rapid glucose availability is needed, such as during exercise or in hypoglycemic conditions. The metabolism of maltose can influence glycogen storage and utilization.

Pharmacokinetics

Maltose is readily absorbed in the intestine after being hydrolyzed into glucose. The absorption occurs primarily in the small intestine, where glucose is transported via sodium-glucose transporters (SGLT). Once in the bloodstream, glucose is distributed to tissues for energy utilization or stored as glycogen in the liver and muscles. The half-life of maltose in the bloodstream is short, as it is quickly converted to glucose.

Pregnancy

Maltose is generally considered safe during pregnancy as it is a naturally occurring sugar. However, it should be consumed in moderation.

Breast-feeding

Maltose is not known to have any adverse effects during breastfeeding and can be considered safe.

Storage

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

Formulations

• Oral solution
• Powder for reconstitution
• Tablets

Indications

• Preservative in vaccines
• Antibacterial agent
• Antifungal agent

Dosage

Children: Refer to the BNF for Children for specific dosage guidelines, especially in

Adults: Refer to specific product guidelines or the BNF for detailed dosage information, as thimerosal is primarily used as a preservative in vaccines rather than in therapeutic doses.

Mechanism of action

Thimerosal inhibits sulfhydryl-containing active sites of various enzymes and binds to sulfhydryl compounds, including glutathione and cysteine. It activates the InsP3 calcium channel on the endoplasmic reticulum, leading to the release of intracellular calcium and subsequent cellular functions dependent on calcium signaling. Ethylmercury, the metabolite of thimerosal, is lipophilic and can cross the blood-brain barrier, contributing to its biological effects.

Pharmacodynamics

Thimerosal exhibits antibacterial and antifungal properties, functioning as a preservative in vaccines. Its pharmacological effects are mediated through interactions with cellular thiols and modulation of calcium signaling pathways. The toxic effects of high doses of thimerosal, such as oxidative stress and apoptosis, have been observed in vitro, although the effects of low-dose exposure remain less understood.

Pharmacokinetics

Thimerosal is rapidly metabolized to ethylmercury, which is eliminated from the body more quickly than methylmercury. Ethylmercury has a shorter half-life, leading to limited accumulation and toxic potential when used in vaccine formulations. The octanol/water partition coefficients indicate that both organomercury compounds, including ethylmercury, can primarily exist within cells, allowing them to cross cellular membranes effectively.

Adverse effects

• Hypersensitivity reactions
• Local reactions at injection site
• Neurotoxic effects at high doses
• Possible kidney pathology with toxic quantities

Precautions

• Use with caution in individuals with known hypersensitivity to thimerosal or other mercury compounds
• Monitoring for adverse effects in patients receiving multiple vaccines containing thimerosal

Pregnancy

Thimerosal should be used in pregnant women only if clearly needed, as the effects on fetal development are not fully established.

Breast-feeding

Thimerosal is considered compatible with breastfeeding, but caution is advised due to potential mercury exposure.

Storage

Store in a cool, dry place away from light. Protect from freezing. Ensure proper disposal of any unused or expired vaccine containing thimerosal.

Formulations

• Thimerosal-containing vaccines (various formulations)

Mechanism of action

Although its mechanism of action is not fully understood, thimerosal inhibits sulfhydryl-containing active site of various enzymes and binds to sulfhydryl compounds, including glutathione, cysteine, and sulfhydryl groups of proteins. In addition, thimerosal activates the InsP3 calcium channel on the endoplasmic reticular membrane, thereby triggering the release of intracellular calcium resulting in a calcium-induced calcium-influx of extracellular calcium. Therefore, thimerosal may induce or inhibit various cellular functions that are dependent on the signaling of calcium. Ethylmercury is metabolized to inorganic mercury more rapidly than methylmercury. This difference in metabolism may account for kidney pathology that can result from toxic quantities. Also, whereas the increase in oxidative stress and induction of apoptosis observed in vitro with large doses (405 μg/L to 101 mg/L) of thimerosal may explain its damaging neurological effects. The effects of low-dose ethylmercury are not completely understood to date. It is known, however, that the shorter half-life of ethylmercury (the metabolite of thimerosal) allows for very limited opportunities of ethylmercury derived from thimerosal in vaccines. Ethylmercury is a lipophilic cation that is capable of crossing the blood-brain barrier. The octanol/water partition coefficients of methyl and ethylmercury are 1.4 to 1.8, at intracellular pH and [Cl−], therefore, both organomercury compounds will primarily exist as intracellular lipophilic cations. It has been demonstrated that lipophilic cations accumulate inside mitochondria, in a Nernstian fashion, driven by the steady state membrane potential. As the typical mitochondrial membrane potential of astrocytes and neurons is between 140–170 mV, one would expect the concentration of these organomercury compounds within mitochondria to be approximately 1000 times greater than the cytosolic concentration.

Pharmacodynamics

Thimerosal is an organomercurial compound and derivative of thiosalicyclic acid with antibacterial and antifungal properties. Thimerosal, which consists of approximately 50% mercury by weight, has been one of the most widely used preservatives in vaccines. It is metabolized/degraded to ethylmercury and thiosalicylate. Ethylmercury is an organomercurial that must be carefully distinguished from methylmercury, a closely related substance that has been the focus of many studies. Methylmercury is the type of mercury found in various species of fish. Experimental data demonstrates that the toxicokinetics of thimerosal (ethylmercury) is vastly different from that of methyl-mercury. Thus, methyl-mercury is not a suitable reference for assessing the risk from exposure to thimerosal-derived mercury. Prior to the recent initiative to reduce or eliminate thimerosal from childhood vaccines, the maximum cumulative exposure to mercury via routine childhood vaccinations during the first 6 months of life was 187.5 micrograms. In the most recently formulated vaccines, the maximum cumulative exposure during the first 6 months of life should now be less than 3 micrograms of mercury. Currently, thimerosal may still be used in the early stages of manufacturing of certain childhood vaccines, however, only a trace remains after a chemical purification process. Note that the dose above is indicated for children 1-6 months of age is applicable only in the United States, and other countries may have varying indications.