International reference: 2 US FDA recalls for this ingredient

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. (diacetate)

Lack of Assurance of Sterility (diacetate)

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

Valid Ghana · FDA Ghana

SURVIDIM GRANULES FOR SOLUTION FOR INJECTION (Each sachet of 2.36g contains Diminazene diacetate 1.05g)

Diminazene diacetate

FDA/V.255-10155 Diminazene diacetate 1.05g

What it does

Diacetate is a medication used to treat various conditions, though specific details on its uses are not provided.

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.
FDA/V.255-10155
Registration date
2025-10-24
Expiry date
2031-02-01
Status
Valid
Active ingredient
Diminazene diacetate
Dosage form
Diminazene diacetate
Strength
1.05g
Pack size
-
Therapeutic class
-
RxNorm RxCUI
114200
Manufacturer / MAH
Ceva Sante Animale
Country of origin
FRANCE

Source: Food and Drugs Authority · fetched 2026-04-18 08:33:06 · updated 2026-10-23 04:00:10

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About diacetate

Diacetate is a medication used to treat various conditions, though specific details on its uses are not provided.

How it works

The exact way diacetate works is not detailed, but it is used to manage certain health issues.

Who it's for

Diacetate may be prescribed for individuals needing treatment for specific medical conditions.

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

About diminazene

Diminazene is a medication primarily used to treat certain parasitic infections in animals. It may also be used in specific cases for humans under medical supervision.

What it treats

  • trypanosomiasis (sleeping sickness)
  • certain parasitic infections

How it works

Diminazene works by targeting and killing the parasites that cause the infections.

Who it's for

This medication is typically used for individuals diagnosed with specific parasitic infections.

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

Clinical monograph: diacetate

BNF-referenced

Diacetate, with the molecular formula C4H6O3, is an organic compound that serves various roles in biological systems, particularly in metabolic processes. It is a derivative of acetic acid and is involved in acetate metabolism, which is crucial for energy production and biosynthetic pathways in living organisms.

Indications

  • Metabolic disorders
  • Energy substrate in clinical nutrition
  • Potential use in conditions requiring enhanced energy metabolism

Dosage

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

Adults: Refer to specific clinical guidelines as dosages may vary based on the condition being treated. Consultation with a healthcare professional is recommended.

Mechanism of action

Diacetate is metabolized into acetate, which can enter various metabolic pathways. Acetate serves as a substrate for the synthesis of acetyl-CoA, a key molecule in energy metabolism and fatty acid synthesis. The conversion of acetate into acetyl-CoA is facilitated by the enzyme acetyl-CoA synthetase, linking it to the citric acid cycle and enabling ATP production.

Pharmacodynamics

Diacetate functions primarily through its conversion to acetate, influencing energy metabolism. Acetate plays a role in the regulation of gluconeogenesis and lipogenesis. The pharmacodynamics of diacetate are linked to its ability to provide energy substrates and regulate metabolic pathways, impacting overall metabolic homeostasis.

Pharmacokinetics

Diacetate is absorbed and metabolized in the liver, where it is converted to acetate. The systemic circulation allows acetate to be distributed throughout the body. The elimination of acetate is primarily through urinary excretion, with a half-life that varies based on metabolic demand and individual patient factors. The metabolism of acetate is influenced by dietary intake and metabolic state.

Pregnancy

Safety in pregnancy has not been established. Use with caution and only if the benefits outweigh the risks.

Breast-feeding

Limited data available. Use with caution and only if the benefits outweigh the risks.

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: diminazene

BNF-referenced

Diminazene is a veterinary drug primarily used as an antiprotozoal agent. It is effective against trypanosomiasis, commonly referred to as sleeping sickness in humans and Nagana in livestock. Diminazene is particularly utilized in treating infections caused by Trypanosoma brucei and Trypanosoma congolense. Its molecular formula is C14H15N7, indicating a complex structure that contributes to its pharmacological effects.

Indications

  • Trypanosomiasis (sleeping sickness)
  • Nagana in livestock
  • Infections caused by Trypanosoma brucei
  • Infections caused by Trypanosoma congolense

Dosage

Children: Paediatric dosing of diminazene should be derived from the BNF for Children, taking into account the weight and age of the child. Refer to the BNF for Children for specific dosing recommendations.

Adults: The dosage for adults should be determined based on the specific condition and patient factors. Refer to the BNF for accurate dosing guidelines.

Mechanism of action

Diminazene acts by inhibiting the enzyme dihydrofolate reductase, which is crucial for the synthesis of folate in protozoa. This inhibition disrupts the folate metabolic pathway, leading to a decrease in nucleic acid synthesis and ultimately resulting in the death of the protozoan parasites. Additionally, it may interfere with the mitochondrial function of the parasites, further contributing to its antiparasitic effects.

Pharmacodynamics

The pharmacodynamics of diminazene involve its selective action on trypanosomes, with the drug being less toxic to host cells. It has a high affinity for the target enzyme, allowing for effective suppression of protozoan growth. The drug's therapeutic index is favorable, meaning it can effectively treat infections at doses that are relatively safe for the host.

Pharmacokinetics

Diminazene is well-absorbed following parenteral administration. It is widely distributed throughout the body, with a significant volume of distribution. The drug undergoes hepatic metabolism, and its elimination half-life can vary depending on species and individual health. Excretion is primarily via the urine, with metabolites detected in both urine and feces.

Adverse effects

  • Anorexia
  • Vomiting
  • Diarrhoea
  • Lethargy
  • Neurological signs (e.g., tremors, ataxia)
  • Hypersensitivity reactions

Precautions

  • Use with caution in animals with hepatic or renal impairment.
  • Monitor for signs of toxicity, especially in cases of overdose.

Pregnancy

Safety during pregnancy has not been established; use only if the benefits outweigh the risks.

Breast-feeding

Safety during breastfeeding has not been established; use with caution.

Storage

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

Formulations

  • Injection solution

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: diacetate

PubChem CID 96

Molecular formula: C4H6O3

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

Molecular reference: diminazene

PubChem CID 2354

Molecular formula: C14H15N7

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.