Dotarem Gadoterate Meglumine Injection 0.5 mmol/mL Prefilled Syringe 20 mL x 10/Pack

Dotarem (gadoterate meglumine) injection is a gadolinium-based contrast agent (GBCA) designed to enhance the quality of magnetic resonance imaging (MRI) scans. This prescription medication is administered intravenously by a healthcare professional.

Dotarem® (Gadoterate Meglumine) Injection is a premium, FDA-approved gadolinium-based contrast agent (GBCA) formulated to enhance the quality, detail, and diagnostic accuracy of Magnetic Resonance Imaging (MRI) scans. Each 20 mL prefilled syringe is ready-to-use, providing hospitals and imaging centers with superior efficiency and patient care. Packaged conveniently in a set of 10, Dotarem delivers consistent results and optimal workflow management for high-volume clinical settings.

How Dotarem works

Dotarem increases the contrast of specific tissues, blood vessels, and organs during an MRI, helping doctors more easily identify and diagnose medical conditions. It is frequently used in MRI examinations of the brain, spine, and surrounding tissues to highlight areas with abnormal blood flow or a compromised blood-brain barrier.

What Is Dotarem Used For?

Dotarem is indicated for:

• Magnetic Resonance Imaging (MRI) of the brain, spine, and the whole body (including musculoskeletal system) to improve visualization of abnormal structures or lesions.
• Central nervous system (CNS) imaging: Better delineation of brain tumors, multiple sclerosis lesions, infections, or trauma.
• MRI of the head and neck, heart, vessels (MR angiography), and other organs when enhanced tissue discrimination is needed for diagnosis.

Product Details & Features

• Active Ingredient: Gadoterate Meglumine (0.5 mmol/mL)
• Volume: Each prefilled syringe contains 20 mL (10 syringes per pack)
• Concentration: 0.5 mmol/mL of gadolinium
• Administration Route: Intravenous (IV) injection only
• Sterile, non-pyrogenic, preservative-free
• Latex-free, ready-to-use prefilled syringes: Ensure consistent dosing and sterile technique
• Manufacturer: Guerbet – a global leader in diagnostic contrast agents
• NDC: [Ask your supplier or check packaging]
• For single use only

Key Features

• Macrocyclic, ionic structure: Increases stability and minimizes risk of gadolinium release, promoting patient safety.
• Enhanced MRI clarity: Produces high contrast between normal and abnormal tissues, aiding in accurate diagnosis.
• High safety profile: Established low rates of adverse reactions; suitable for pediatric and adult patients.
• Ready-to-use syringes: Improve convenience, reduce preparation errors, and speed up workflow in busy radiology departments.
• Low risk of nephrogenic systemic fibrosis (NSF): Trusted in patients with impaired renal function compared to less stable linear GBCAs.

Directions for Use

• For professional use only—must be administered by trained healthcare personnel.
• Inspect the syringe before use. Do not use if particulate matter or discoloration is present, or if packaging is damaged.
• Inject Dotarem intravenously as a bolus (manual or power injector).
• Use aseptic technique. Remove syringe cap and attach a sterile, compatible IV needle or cannula.
• Discard any unused portion immediately after administration.
• Monitor the patient closely during and after injection for signs of hypersensitivity or adverse reactions.

Dosage

• Recommended dose for adults and pediatric patients (2 years and older):
  • 0.2 mL/kg (0.1 mmol/kg) body weight, administered as a single intravenous injection.
  • Example: For a 70 kg adult, inject 14 mL IV.
• Maximum dose: Should not exceed 0.3 mmol/kg (per body weight).
• Repeat scans should be separated by sufficient time to complete excretion; consult prescribing information.

Pediatric Use: Safety established in children (2 years and older). Use in infants under 2 years only if essential.

CDC Guidelines & Professional Best Practices

• Adhere to the CDC’s guidelines on safe injection practices, including:
  • Use of a new syringe and needle for each patient.
  • Compliance with aseptic technique to minimize infection risk.
  • Appropriate patient screening for history of allergic reactions to GBCAs.
• Monitor all patients during and for at least 30 minutes following contrast administration for potential hypersensitivity reactions.
• Evaluate kidney function prior to administration, especially in patients at risk for renal insufficiency.
• Report all adverse drug reactions and medication errors according to medical facility protocols and regulations.

Warnings

• Serious hypersensitivity reactions, including anaphylaxis, can occur: Be prepared to treat immediately.
• Nephrogenic Systemic Fibrosis (NSF): Risk increases in patients with severe kidney dysfunction; assess renal function prior to administration.
• Avoid use in patients with known hypersensitivity to gadoterate meglumine or other GBCAs.
• Not recommended for use during pregnancy unless clearly necessary.
• Use with caution in breastfeeding women; consider temporary discontinuation of breastfeeding post-administration.
• Intended for intravenous use only.
• For single-use only. Do not reuse syringes to prevent infection or cross-contamination.

Possible Side Effects

Most Common:

• Nausea
• Headache
• Injection site pain or cold sensation

Less Common/Serious:

• Hypersensitivity reactions (rash, pruritus, urticaria, swelling, respiratory difficulty)
• Anaphylactic reactions (very rare, but life-threatening)
• NSF, especially in patients with severe renal impairment

Seek immediate medical attention for:

• Trouble breathing
• Facial, tongue, or throat swelling
• Severe skin reactions or hives

Dotarem (Gadoterate Meglumine) Injection by Guerbet: Your trusted choice for high-resolution, safe, and reliable MRI imaging in adults and pediatric patients. Ensure every MRI counts with Dotarem—delivering diagnostic confidence and patient safety every time.

Always consult a radiologist or healthcare professional before use. Use only as directed.

Guerbet – Pioneer in Diagnostic Imaging Enhance Your MRI. Improve Your Diagnosis.