Registered Tanzania · TMDA

Clariscan

Meglumine 97.6 mg/5.26ml,Water for injections q.s q.s,gadoterate meglumine equivalent to gadoteric acid 279.3 mg/5.26ml

TAN 21 HM 0255 Solution for injection INN generic

What it does

Gadoterate is a contrast agent used in medical imaging to help doctors see clearly inside the body.

Commonly used for: imaging of the brain (such as MRI scans), imaging of the spine, imaging of other body parts

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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 HM 0255
Registration date
2021-06-03
Expiry date
2026-06-02
Status
Registered/Compliant
Active ingredient
Meglumine 97.6 mg/5.26ml,Water for injections q.s q.s,gadoterate meglumine equivalent to gadoteric acid 279.3 mg/5.26ml
Strength
-
Pack size
-
Therapeutic class
-
RxNorm RxCUI
1649574
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 · updated 2026-06-02 06:16:20

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

About gadoterate

Gadoterate is a contrast agent used in medical imaging to help doctors see clearly inside the body.

What it treats

  • imaging of the brain (such as MRI scans)
  • imaging of the spine
  • imaging of other body parts

How it works

Gadoterate enhances the contrast of images taken during scans, allowing for better visualization of tissues and organs.

Who it's for

This medicine is for patients undergoing MRI scans to help diagnose or monitor various conditions.

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

About gadoteric

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.

About injections

Injections are a method of delivering medication directly into the body using a syringe and needle.

What it treats

  • administering vaccines
  • treating infections
  • managing pain
  • delivering hormones
  • providing nutrients

How it works

Injections allow medicines to enter the bloodstream quickly, helping them work faster than oral medications.

Who it's for

Injections may be used for anyone who needs medication that cannot be taken by mouth or needs rapid effect.

Cautions

  • • May cause discomfort or pain at the injection site.
  • • Risk of infection if not administered properly.
  • • Some people may have allergic reactions to injected medications.

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

About meglumine

Meglumine is a compound often used in medical imaging and diagnostic procedures.

What it treats

  • medical imaging
  • diagnostic procedures

How it works

Meglumine helps to enhance the visibility of certain areas in the body during imaging tests, making it easier for healthcare providers to see and diagnose conditions.

Who it's for

Meglumine is used for patients undergoing specific imaging tests, such as X-rays or CT scans.

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

Clinical monograph: gadoterate

BNF-referenced

Gadoterate is a gadolinium-based contrast agent used in magnetic resonance imaging (MRI). It is indicated for enhancing the quality of MRI scans by improving the visibility of blood vessels and tissues. The compound contains gadolinium, a paramagnetic metal ion, which alters the magnetic properties of nearby water molecules, thereby increasing the contrast in imaging.

Indications

  • Magnetic resonance imaging in various anatomical regions
  • Evaluation of vascular diseases
  • Assessment of tumors and other lesions

Dosage

Children: Refer to the BNF for Children for specific paediatric dosing information, as it may vary based on age and weight.

Adults: The recommended dose for adults is typically 0.1 mmol/kg body weight, administered as a slow intravenous injection. The exact dosage may vary based on the specific imaging requirements and protocols.

Mechanism of action

Gadoterate works by providing contrast during MRI procedures through its paramagnetic properties. When injected into the bloodstream, gadoterate influences the magnetic resonance signals of surrounding water protons. The presence of gadolinium ions enhances signal intensity, allowing for clearer imaging of vascular structures and pathological lesions.

Pharmacodynamics

Gadoterate exhibits a strong magnetic susceptibility due to the gadolinium ion, which assists in altering the relaxation times of nearby protons in tissues. This leads to improved contrast differentiation between normal and abnormal tissues in MRI. The degree of enhancement depends on the concentration of the contrast agent and the specific MRI sequences used.

Pharmacokinetics

After intravenous administration, gadoterate is rapidly distributed in the vascular system, with the peak concentration occurring within minutes. It has a volume of distribution that reflects the extracellular fluid space. The elimination half-life is typically around 1.5 to 2 hours, with the majority of the drug excreted unchanged in urine within 24 hours. Gadoterate does not undergo significant metabolism.

Pregnancy

There is limited data on the use of gadoterate in pregnancy. It should only be used if the benefits outweigh the risks.

Breast-feeding

It is not known whether gadoterate is excreted in human milk. Caution is advised when administering to breastfeeding mothers.

Storage

Store at 15 to 25 degrees Celsius. Protect from light and freeze.

Formulations

  • Injection

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: 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.

Clinical monograph: injections

Injections refer to the administration of a substance directly into the body through a syringe and needle. This method is commonly used for delivering medications, vaccines, or biological therapies. Injections can be administered intravenously, intramuscularly, subcutaneously, or intradermally, depending on the drug's properties and the desired effect. This route ensures rapid onset of action, making it ideal for emergencies or when immediate therapeutic effects are required.

Indications

  • Pain management
  • Vaccination
  • Antibiotic therapy
  • Hormonal therapies
  • Anesthesia
  • Nutritional support
  • Chemotherapy

Dosage

Children: Refer to specific drug guidelines for paediatric dosing, as it requires careful consideration of weight and age.

Adults: Refer to specific drug guidelines for adult dosing, as it varies widely depending on the medication and clinical condition.

Mechanism of action

The mechanism of action of injected drugs varies widely based on the specific medication being administered. Generally, injected drugs enter the bloodstream directly, allowing them to circulate rapidly throughout the body. For instance, antibiotics may work by inhibiting bacterial cell wall synthesis, while analgesics may modulate pain pathways in the central nervous system. Each drug has unique pathways through which it achieves its therapeutic effects.

Pharmacodynamics

Pharmacodynamics refers to the effects of drugs on the body and their mechanisms of action. For injectable medications, effects can be immediate or delayed, depending on the drug's formulation and route of administration. Factors influencing pharmacodynamics include receptor affinity, drug concentration, and the presence of other substances that may enhance or inhibit the drug's effects. For example, some injectable drugs may require specific receptors to exert their effects, while others may have a broader range of action.

Pharmacokinetics

Pharmacokinetics involves the absorption, distribution, metabolism, and excretion (ADME) of injected drugs. After administration, drugs are rapidly absorbed into the bloodstream, leading to quick therapeutic effects. The distribution depends on factors such as blood flow, tissue permeability, and protein binding. Drugs are metabolized primarily in the liver and excreted through the kidneys or bile. The pharmacokinetic profile can vary widely based on the drug's chemical nature, dosage, and individual patient factors.

Pregnancy

Safety during pregnancy depends on the specific injection and its active ingredients. It is essential to consult a healthcare professional for guidance.

Breast-feeding

The safety of injections during breastfeeding varies by the specific medication. It is recommended to seek advice from a healthcare provider.

Storage

Store injections as per manufacturer's guidelines, usually in a cool, dry place away from direct sunlight. Some may require refrigeration.

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: meglumine

BNF-referenced

Meglumine is a compound used primarily as a pharmaceutical excipient and as a solubilizing agent in various medical preparations. It is a derivative of glucuronic acid and functions as a stabilizer for certain drug formulations, particularly in radiologic contrast media. Meglumine enhances the solubility of active ingredients, thereby improving their bioavailability.

Indications

  • Used as a solubilizing agent in pharmaceutical preparations
  • Used in radiographic contrast media formulations

Dosage

Children: Refer to specific formulations for paediatric dosing instructions as it varies depending on the application.

Adults: Refer to specific formulations for adult dosing instructions as it varies depending on the application.

Mechanism of action

Meglumine acts by enhancing the solubility and stability of drugs in solution, particularly in radiographic contrast agents. It is involved in purinergic signaling pathways, which are essential for various physiological processes, including neurotransmission and inflammation.

Pharmacodynamics

The pharmacodynamic profile of meglumine is largely influenced by its role as a solubilizing agent. It does not exhibit direct pharmacological effects on its own but rather facilitates the action of other active ingredients in formulations. Its impact on purinergic signaling may contribute to modulating physiological responses in the body.

Pharmacokinetics

Meglumine is rapidly absorbed when administered, with its pharmacokinetics closely tied to the properties of the drugs it accompanies. The distribution, metabolism, and excretion of meglumine are not well-defined as it typically functions as an excipient rather than an active therapeutic agent. Its elimination from the body is primarily via renal pathways.

Pregnancy

There is insufficient data on the use of meglumine in pregnancy, therefore it should only be used if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Caution is advised when administering meglumine to breastfeeding women, as its effects on infants are not well studied.

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.

Molecular reference: gadoterate

PubChem CID 450231

Molecular formula: C16H24GdN4O8-

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

Molecular reference: meglumine

PubChem CID 8567

Molecular formula: C7H17NO5

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.