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Roniscan®

Patient Details

Roniscan®

Generic Name: Gadodiamide
Dosage Form: Injectable solution containing 287 mg/mL of gadodiamide
Drug Class: Gadolinium-based contrast agent
Indications: Roniscan® is used for MRI of the central nervous system, chest (non-cardiac), abdomen, pelvis, and retroperitoneal space to enhance lesion visibility.


Roniscan®

Roniscan® (Gadodiamide) is a contrast agent that, when placed in an external magnetic field, generates magnetic effects in the target tissue, enabling high-quality imaging.


Indications for Roniscan®

  • Magnetic Resonance Imaging (MRI) of the central nervous system, chest (non-cardiac), abdomen, pelvis, and retroperitoneal space
  • Magnetic Resonance Angiography (MRA)
  • Musculoskeletal imaging

Dosage Form

Vial containing 15 mL injectable solution (287 mg/mL)


Preparation of Roniscan®

Roniscan® is a ready-to-use solution; no preparation is needed.


Administration and Dosage of Roniscan®

  • IV only: Do not administer intrathecally; may cause sensory/motor nerve damage, seizures, or coma.
  • Solution is colorless to pale yellow; inspect for discoloration or particulate matter before use. Do not use if particles or color changes are observed.
  • Use the solution immediately after drawing it into a syringe; discard any remaining solution.
  • Optionally, follow with 5 mL of 0.9% sodium chloride to ensure complete administration.
  • Imaging should be completed within 1 hour after injection.
  • Following administration in musculoskeletal imaging, the injection site was flushed with 40 mL NS.

Monitoring Requirements During Roniscan® Therapy

  • Signs of hypersensitivity during and shortly after injection
  • Kidney function (prior to contrast administration)
  • Short- and long-term monitoring for nephrogenic systemic fibrosis (NSF): itching, swelling, skin tightening, joint stiffness, pelvic or rib bone pain, muscle weakness
  • Pregnancy status before use

Contraindications

  • Hypersensitivity to gadodiamide or any component of the formulation
  • Acute or chronic severe kidney failure (GFR <30 mL/minute/1.73 m2
  • Neonates up to 4 weeks of age (due to their immature renal function).

Warnings and Precautions

  • In patients with kidney impairment, inflammatory diseases, pregnant women, and children, gadolinium may remain longer in the body; use the minimum necessary for imaging.
  • Gadolinium-based agents may increase the risk of nephrogenic systemic fibrosis (NSF); use only when essential and when an MRI without contrast cannot provide sufficient diagnostic information.
  • Patients should be closely monitored during and for a few hours after injection, especially those with drug allergies, asthma, or other allergic conditions. Stop injection and initiate treatment immediately if severe allergic reactions occur (skin, respiratory, cardiovascular).
  • Creatinine clearance should be calculated for patients at risk of reduced kidney function (e.g., age >60, hypertension, diabetes) and dosing decisions made accordingly.

Use During Pregnancy and Breastfeeding

  • Consult a physician before use during pregnancy or breastfeeding.
  • Gadodiamide may cross the placenta; use only if the benefits outweigh potential fetal risks.
  • Gadodiamide may be excreted in breast milk; decisions on use should consider maternal benefit vs. potential risk to the infant.

Side Effects of Roniscan®

Possible side effects (not all patients experience these):

  • Headache and dizziness
  • Abdominal pain, nausea, or vomiting
  • Local injection site reactions
  • Shortness of breath

Drug Interactions

Consult a doctor or pharmacist before using Roniscan® with other medications or supplements.


Packaging

Each package contains 1 vial of Roniscan®.


Storage

  • Store below 25°C, protected from light and moisture.
  • Protect from freezing.
  • Use by the expiration date; do not use expired products.
  • Keep out of reach of children.
  • Keep in the original packaging until use.

References

  1. Gadodiamide: Drug information, UpToDate 2025
  2. Drugs.com – Gadodiamide