International reference: 3 US FDA recalls for this ingredient

cGMP deviations: Temperature abuse (diluent)

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. (diluent)

Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags. (diluent)

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

Registered Zambia · ZAMRA

Cadiprim Eye/Ear drops

Sterile diluent 20% Packs

113/059 Ear/Eye Drops 20% Packs

What it does

Diluent is a substance that helps to mix or dissolve other medications, making them easier to administer.

Commonly used for: preparing injections, mixing powdered medications

Read more in plain English ↓

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

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
113/059
Registration date
2004-01-01
Expiry date
2015-08-05
Status
Registered/Compliant
Active ingredient
Sterile diluent 20% Packs
Dosage form
Ear/Eye Drops
Strength
20% Packs
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Cadila Pharmaceuticals
Country of origin
India
Manufacturer location
Bhat, Sarkhej-Dholka Road, Ahmedabad, Bhat, Gujarat 382210, India

Source: Zambia Medicines Regulatory Authority · fetched 2026-03-11 23:59:31 · updated 2026-05-22 02:38:52

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

About diluent

Diluent is a substance that helps to mix or dissolve other medications, making them easier to administer.

What it treats

  • preparing injections
  • mixing powdered medications

How it works

Diluent helps to break down and evenly distribute the active ingredients in a medication.

Who it's for

Patients who need medications that are in powdered form or require mixing before use.

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

About packs

Packs are used to treat various medical conditions. Please consult your healthcare provider for specific information.

How it works

Information on how Packs work is not available.

Who it's for

Packs may be suitable for individuals with certain health conditions as advised by a healthcare professional.

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

About sterile

Sterile refers to products that are free from germs and bacteria, ensuring safety for use in medical settings.

What it treats

  • Preparing medications
  • Surgical procedures
  • Injections and infusions

How it works

Sterile products are treated to eliminate all forms of microorganisms, making them safe for medical use.

Who it's for

Patients requiring clean and safe medical products, such as those undergoing surgery or receiving injections.

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

Clinical monograph: diluent

A diluent is a substance used to dilute a drug or active ingredient, thereby reducing its concentration. Dilutents are essential in pharmaceutical preparations to ensure the proper administration of medications, enhance solubility, and facilitate the delivery of the active compound. They can also improve the stability and bioavailability of certain drugs. Common diluents include saline, sterile water, and various sugars or carbohydrates, depending on the formulation requirements.

Indications

  • Reconstitution of powdered medications
  • Dilution of concentrated solutions for injection
  • Preparation of solutions for intravenous administration
  • Enhancement of drug solubility

Dosage

Children: Refer to specific drug product guidelines as doses vary based on the active ingredient and formulation.

Adults: Refer to specific drug product guidelines as doses vary based on the active ingredient and formulation.

Mechanism of action

Dilutents work by increasing the volume of the solution, which allows for easier administration of the active drug. They do not have a pharmacological effect themselves but serve to modify the concentration of the active ingredient for optimal therapeutic effect.

Pharmacodynamics

The pharmacodynamic properties of diluents are largely dependent on the active drug they are used with. They do not exert therapeutic effects on their own but can influence the pharmacological effects of the drug by altering its concentration and distribution in the body.

Pharmacokinetics

Dilutents themselves are generally considered inert and do not undergo significant absorption, distribution, metabolism, or excretion within the body. Their primary role is to facilitate the delivery of the active pharmaceutical ingredient, and their pharmacokinetic properties are largely dictated by the drug they accompany.

Pregnancy

The safety of diluents during pregnancy has not been well-established. Caution is advised when using any diluent in pregnant women, and the benefits should be weighed against potential risks.

Breast-feeding

The effects of diluents during breastfeeding have not been thoroughly studied. It is recommended to consult a healthcare provider to assess the risks and benefits.

Storage

Diluent should be stored at room temperature, away from light and moisture. Check specific product labels for any additional storage instructions.

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: packs

Packs are typically used in pharmacology as packaging for medications, which can include various forms such as tablets, capsules, liquids or injections. Each pack is designed to contain a specific quantity of a medication, ensuring proper dosage, stability and protection from environmental factors. The design of the pack may vary based on the form of the medication and its intended use.

Dosage

Children: Refer to specific medication packaging for dosage information.

Adults: Refer to specific medication packaging for dosage information.

Pregnancy

Safety during pregnancy has not been established. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Excretion in breast milk is unknown. Caution is advised when administering to nursing mothers.

Storage

Store in a cool, dry place away from light. 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: sterile

Sterile refers to a state in which a substance, typically a pharmaceutical product or medical device, is free from all living microorganisms, including bacteria, viruses, fungi, and spores. Achieving sterility is essential for products intended for injection, surgical use, or any application where the introduction of microbes could lead to infection or contamination. Sterilization methods include autoclaving, filtration, ethylene oxide gas, and radiation.

Indications

  • Surgical procedures
  • Injection of medications
  • Preparation of sterile pharmaceutical products
  • Management of open wounds
  • Use in controlled environments such as hospitals and laboratories

Dosage

Children: Refer to specific drug monographs for dosage information as sterile itself is not a pharmacological agent.

Adults: Refer to specific drug monographs for dosage information as sterile itself is not a pharmacological agent.

Mechanism of action

Sterility itself does not have a mechanism of action as it is a state of cleanliness and does not interact with biological systems. However, the methods used to achieve sterility, such as heat or chemical agents, act by denaturing proteins, disrupting cellular structures, or damaging nucleic acids in microorganisms, leading to their inactivation or destruction.

Pharmacodynamics

The pharmacodynamics of sterile techniques primarily involves the prevention of microbial infection and contamination when administering medications. By ensuring that products are sterile, the risk of adverse effects related to infections is minimized. The effectiveness of sterilization methods can be influenced by factors such as temperature, duration of exposure, and the type of microorganisms present.

Pharmacokinetics

As sterility does not pertain to a specific drug, pharmacokinetics is not applicable. However, the pharmacokinetics of a drug will depend on its formulation, route of administration, and the presence of preservatives or stabilizers that may be used alongside sterile preparations.

Pregnancy

Sterile preparations are generally considered safe during pregnancy as they are used to provide hydration, nutrition, or medications in a controlled manner, but specific formulations should be assessed individually.

Breast-feeding

Sterile solutions used for hydration or nutritional support are typically safe during breastfeeding, but any specific additives or medications within the solutions should be evaluated for safety.

Storage

Sterile solutions should be stored in a cool, dry place, protected from light, and should be used before the expiration date. Once opened, they may have specific storage requirements based on the formulation.

Formulations

  • Sterile saline solution
  • Sterile water for injection
  • Sterile dextrose solution
  • Sterile electrolyte solutions

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.