DOTAREM 0.5MOL-L GLASS BOTTLE W-STOPPER 27.932 mmol/ml Solution for injection 15ml Vial

Product Overview

Dotarem 0.5 mmol/mL Solution for injection is a gadolinium-based contrast agent used for magnetic resonance imaging (MRI).
It is designed to enhance the visibility of abnormal structures or lesions in various parts of the body, aiding in accurate diagnosis.
This product comes in a 15ml glass bottle with a stopper, intended for single-patient use and administered by healthcare professionals.

Benefits of Use

Dotarem enhances contrast in MRI scans, allowing for:
- Improved detection and delineation of lesions in the brain, spine, and other body regions.
- Better visualization of vascular structures and perfusion.
- More accurate assessment of disease extent, progression, and characterization.
- Essential for various diagnostic indications where enhanced MRI is required.

How to Use

Dotarem should only be administered by a qualified healthcare professional experienced in MRI procedures.
1. Confirm patient suitability, including renal function and absence of contraindications.
2. Aseptically draw the required dose of Dotarem from the 15ml vial.
3. Administer intravenously as a bolus injection or slow infusion at the recommended dosage (typically 0.1 mmol/kg body weight).
4. Conduct the MRI scan following administration as per standard clinical protocols.
5. Monitor the patient for any immediate or delayed adverse reactions.
6. Dispose of any unused solution and the vial according to local regulations for medical waste.

Caution & Warnings

- **Hypersensitivity Reactions**: Anaphylactoid reactions, including severe ones, can occur. Emergency resuscitation equipment and trained personnel should be readily available.
- **Nephrogenic Systemic Fibrosis (NSF)**: There is a risk of NSF in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2) or acute kidney injury. Avoid use in these patients unless essential.
- **Renal Impairment**: Exercise caution in patients with moderate renal impairment. Renal function screening (eGFR) is recommended for all patients prior to administration.
- **Pregnancy and Lactation**: Use during pregnancy only if clearly needed and the potential benefits outweigh the risks. Exercise caution when administered to lactating women.
- **Pediatric Use**: Efficacy and safety have been established in children and neonates, but dosage must be carefully determined.
- **Extravasation**: Avoid extravasation during injection, as it may cause local tissue irritation or necrosis.
- **Concomitant Medications**: Inform the prescribing physician of all medications being taken.

Ingredients

**Active Ingredient:** Gadoterate meglumine (equivalent to 0.5 mmol/mL gadoterate).
**Excipients:** Meglumine, Water for injections.

Product Details

**Form:** Solution for injection
**Strength:** 0.5 mmol/mL
**Volume:** 15 mL
**Container:** Glass bottle with stopper
**Manufacturer:** Guerbet