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 Kenya.

Registered Kenya · PPB

TOGOZED 2GM

SPECTINOMYCIN + DILUENT

H2010/22641/846 2GM GENERIC/BIOSIMILARS INN generic

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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Registration & product details

Registration no.
H2010/22641/846
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
SPECTINOMYCIN + DILUENT
Dosage form
2GM
Strength
-
Pack size
VIAL
Therapeutic class
GENERIC/BIOSIMILARS
Manufacturer / MAH
Zawadi Healthcare
Applicant / LTR
ZAWADI HEALTHCARE LIMITED
Country of origin
FOREIGN
Manufacturer location
Shop 2, Next To Gen. Shop, Near Deliverance Church, Off Depot Road, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 20:08:18 · updated 2026-08-03 04:08:34

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). 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 spectinomycin

Spectinomycin is an antibiotic used to treat certain bacterial infections.

What it treats

  • gonorrhea (a sexually transmitted infection)
  • bacterial infections

How it works

It stops the growth of bacteria, helping to eliminate the infection.

Who it's for

It is usually prescribed for adults and sometimes for children, depending on the infection.

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: spectinomycin

BNF-referenced

Spectinomycin is an aminocyclitol antibiotic that inhibits protein synthesis in bacteria, specifically targeting the 30S ribosomal subunit. It is primarily used in the treatment of gonorrhea and is effective against most strains of Neisseria gonorrhoeae. Spectinomycin is derived from Streptomyces spectabilis, a soil microorganism.

Indications

  • Gonorrhea
  • Neisseria gonorrhoeae infection

Dosage

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

Adults: Refer to specific BNF guidelines for dosing details.

Mechanism of action

Spectinomycin acts as an inhibitor of protein synthesis by binding to the 30S ribosomal subunit in bacterial cells. This binding interferes with the process of translation, leading to bactericidal effects.

Pharmacodynamics

Spectinomycin demonstrates significant antibacterial activity against Neisseria gonorrhoeae, with minimum inhibitory concentrations ranging from 7.5 to 20 mcg/mL. Its unique mechanism involves regional effects on ribosomal structure, which disrupts the normal function of bacterial protein synthesis.

Pharmacokinetics

Spectinomycin is administered via intramuscular injection and achieves peak plasma concentrations within 1 to 2 hours post-administration. The drug is widely distributed in body tissues and fluids, including the renal system, and is primarily excreted unchanged in the urine. The half-life of spectinomycin is approximately 2 to 3 hours, though this may vary based on renal function.

Contra-indications

  • Hypersensitivity to spectinomycin or any component of the formulation
  • Severe renal impairment

Adverse effects

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Rash
  • Allergic reactions

Interactions

  • May interact with other aminoglycoside antibiotics
  • Concurrent use with nephrotoxic or ototoxic drugs may increase the risk of toxicity

Precautions

  • Use with caution in patients with renal impairment
  • Monitor renal function during treatment
  • Assess for a history of allergy to antibiotics

Pregnancy

Safety in 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 spectinomycin is excreted in human milk. Caution should be exercised when administering to nursing mothers.

Storage

Store at room temperature, away from light and moisture. Keep out of reach of children.

Formulations

  • Spectinomycin injection for intramuscular use

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: spectinomycin

PubChem CID 15541

Molecular formula: C14H24N2O7

Mechanism of action

Spectinomycin is an inhibitor of protein synthesis in the bacterial cell; the site of action is the 30S ribosomal subunit. It is bactericidal in its action.

Pharmacodynamics

Spectinomycin is an aminocyclitol antibiotic produced by a species of soil microorganism designated as S<i>treptomyces spectabilis</i>. In vitro studies have shown spectinomycin to be active against most strains of <i>Neisseria gonorrhoeae</i> (minimum inhibitory concentration <7.5 to 20 mcg/mL). Footprint studies indicate that spectinomycin exerts regional effects on ribosomal structure.

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

This drug in other countries

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