Registered Tanzania · TMDA

Clariscan Solution for Injection

Gadoteric acid 279.3 mg

TAN 21 HB 0152 Solution for injection

What it does

Gadoteric is a contrast agent used in medical imaging to help highlight areas of the body in scans.

Commonly used for: magnetic resonance imaging (MRI), medical imaging

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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 21 HB 0152
Registration date
2021-03-29
Expiry date
2026-03-28
Status
Registered/Compliant
Active ingredient
Gadoteric acid 279.3 mg
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
GE Healthcare
Applicant / LTR
GE Healthcare AS
Country of origin
NORWAY
Manufacturer location
Nycoveien 1, 0485 Oslo, Norway

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:53:01

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

About this medicine

Gadoteric is a contrast agent used in medical imaging to help highlight areas of the body in scans.

What it treats

  • magnetic resonance imaging (MRI)
  • medical imaging

How it works

It works by enhancing the visibility of internal body structures during imaging tests.

Who it's for

It is used for patients needing detailed images of their organs or tissues.

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

Clinical monograph: gadoteric

Gadoteric is a contrast agent primarily used in magnetic resonance imaging (MRI) procedures. It is a gadolinium-based compound that enhances the visibility of internal structures in the body, allowing for improved diagnostic accuracy. Gadoteric is particularly useful in imaging soft tissues, vascular structures, and the central nervous system.

Indications

  • Magnetic resonance imaging of the brain and spinal cord
  • Magnetic resonance angiography
  • Assessment of tumors and lesions in various tissues
  • Evaluation of vascular malformations
  • Imaging of the abdomen and pelvis

Dosage

Children: Refer to the specific guidelines provided in the BNF for Children for paediatric dosing.

Adults: Refer to the specific guidelines provided in the BNF or local protocols for adult dosing.

Mechanism of action

Gadoteric works by altering the magnetic properties of nearby water protons in the body tissues. The presence of gadolinium ions in the contrast agent shortens the T1 relaxation time of these protons, resulting in increased signal intensity on T1-weighted MRI images. This enhancement provides better contrast between different tissues, helping to highlight abnormalities such as tumors, inflammation, or vascular changes.

Pharmacodynamics

The pharmacodynamics of gadoteric is characterized by its ability to affect the magnetic resonance signal, thus enhancing the visibility of certain tissues during imaging. The efficacy of gadoteric is influenced by its distribution in the body, which is primarily vascular and interstitial. Its contrast effect is contingent upon the concentration of the gadolinium ions at the site of interest and the timing of imaging after administration.

Pharmacokinetics

Gadoteric is administered intravenously and is rapidly distributed throughout the vascular compartment. It has a low protein binding capacity and is primarily excreted unchanged via the kidneys. The elimination half-life of gadoteric is approximately 1.5 to 2 hours in patients with normal renal function. In cases of renal impairment, the elimination may be prolonged, necessitating careful consideration of the patient's renal status before administration.

Contra-indications

  • Hypersensitivity to gadoteric acid or any of the excipients
  • Severe renal impairment (eGFR <30 mL/min)

Adverse effects

  • Nausea
  • Headache
  • Dizziness
  • Injection site reactions
  • Hypersensitivity reactions
  • Nephrogenic systemic fibrosis (in patients with severe renal impairment)

Interactions

  • Other gadolinium-based contrast agents
  • Certain medications that affect renal function may increase the risk of nephrogenic systemic fibrosis

Precautions

  • Use with caution in patients with renal impairment
  • Assess renal function before administration
  • Monitor for signs of hypersensitivity during and after administration

Pregnancy

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

Breast-feeding

It is not known whether gadoteric is excreted in human milk. Caution should be exercised when administering to a nursing mother.

Storage

Store at 20-25 degrees Celsius. Protect from light. Do not freeze.

Formulations

  • Gadoteric acid 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.

This drug in other countries

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