GNH USA

Europe — EMA

Kiralda

GNH USA supplies Kiralda (Gadobutrol), a Gadolinium-based contrast agent for MRI of the brain, spine, musculoskeletal system, abdomen and pelvis.

Gadobutrol

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What is Gadobutrol?

Gadobutrol, the active ingredient in Kiralda, is a Gadolinium-based contrast agent presented as a sterile injectable solution for intravenous use. It enhances magnetic resonance imaging by increasing signal intensity on T1‑weighted sequences, aiding diagnosis in a variety of clinical settings.

GNH USA supplies Kiralda as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

What is Gadobutrol used for?

Kiralda (gadobutrol) is used as a gadolinium‑based contrast agent to improve magnetic resonance imaging across several anatomical regions.

- Brain MRI: provides enhanced visualization of intracranial structures and pathology. - Spine MRI: improves delineation of the spinal cord, vertebrae and surrounding tissues. - Musculoskeletal MRI: increases contrast of joints, muscles and bone lesions. - Abdominal and pelvic MRI: enhances detection of lesions in liver, kidneys and pelvic organs. - Magnetic resonance angiography: facilitates clearer depiction of vascular anatomy.

What are the side effects of Gadobutrol?

Adverse reactions to gadobutrol may range from mild to severe. Monitoring patients during and after injection is recommended.

Common Side Effects: - Nausea - Headache - Warm sensation or flushing - Injection site pain or erythema - Dizziness - Mild hypotension

Serious or Rare Side Effects: - Anaphylactic or severe allergic reaction - Nephrogenic systemic fibrosis (especially in severe renal impairment) - Severe hypotension or cardiovascular collapse - Cardiac arrest (very rare) - Acute kidney injury

What precautions apply to Gadobutrol?

Use of gadobutrol requires careful assessment of patient-specific risk factors and proper handling of the product.

- Renal function assessment: evaluate glomerular filtration rate before administration. - History of allergic reactions: screen for prior contrast media hypersensitivity. - Pregnancy considerations: use only if clearly needed, as safety data are limited. - Pediatric use: dose should be calculated by the prescriber based on weight. - Severe renal impairment: avoid or use with extreme caution due to NSF risk. - Store at ambient temperature: keep in original container, protect from light and moisture.

What does Gadobutrol interact with?

Gadobutrol may interact with other agents that affect renal function or increase the risk of hypersensitivity.

Major Interactions (Avoid): - Concurrent use of other gadolinium agents: increased cumulative gadolinium exposure. - High‑dose iodinated contrast agents: additive renal stress. - Nephrotoxic drugs (e.g., aminoglycosides, amphotericin B): heightened risk of renal injury.

Moderate Interactions (Monitor Closely): - Diuretics: may alter renal clearance of gadobutrol. - ACE inhibitors or ARBs: monitor renal function during co‑administration. - Metformin: consider temporary discontinuation in patients with impaired renal function.

Frequently asked questions

What is Kiralda used for?+
Kiralda contains gadobutrol, a gadolinium‑based contrast agent used to improve the quality of magnetic resonance imaging. It is administered intravenously before MRI scans of the brain, spine, musculoskeletal system, abdomen, pelvis, and for magnetic resonance angiography to enhance the visibility of anatomical structures and pathology.
How does gadobutrol work?+
Gadobutrol is a paramagnetic chelate that shortens the T1 relaxation time of nearby water protons. When injected, it distributes into the extracellular fluid and alters local magnetic fields, producing a higher signal on T1‑weighted MRI sequences, which makes tissues appear brighter and improves contrast between normal and abnormal areas.
What is the usual dose of Kiralda?+
The dose of Kiralda is determined by the prescribing physician based on the specific MRI protocol, patient weight, and clinical indication. Dosing is individualized and should follow the recommendations in the product labeling and the radiologist’s instructions.
Is Kiralda safe during pregnancy or breastfeeding?+
Safety data for gadobutrol in pregnancy and lactation are limited. It should only be used when clearly needed and when the potential diagnostic benefit outweighs any possible risk to the fetus. Breastfeeding mothers should discuss use with their healthcare provider, as the drug may be excreted in milk.
How do I order Kiralda from GNH USA?+
To order Kiralda, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain if required) and any necessary import documentation.
How does Kiralda compare with other MRI contrast agents?+
Gadobutrol (Kiralda) is a high‑relaxivity, non‑ionic gadolinium chelate that provides strong T1 shortening at a relatively low dose compared with some older agents. Its safety profile is comparable to other macrocyclic gadolinium agents, with a lower risk of dissociation and nephrogenic systemic fibrosis, especially in patients with normal renal function.
What are the storage and handling requirements for Kiralda?+
Kiralda should be stored at ambient temperature, below 25 °C, in its original packaging. Protect the product from direct sunlight, moisture and extreme temperatures. Do not freeze the solution, and inspect the vial for particulate matter before use.
How is Kiralda administered?+
Kiralda is administered as an intravenous injection, typically as a bolus or a slow infusion immediately before the MRI examination. The exact rate and volume are determined by the imaging protocol and the prescribing clinician.
What are the most serious risks associated with Kiralda?+
The most serious risks include severe allergic reactions such as anaphylaxis, and nephrogenic systemic fibrosis (NSF) in patients with severe renal impairment. Prompt recognition of these reactions and appropriate medical intervention are essential.
Who should not receive Kiralda?+
Kiralda should be avoided in patients with known hypersensitivity to gadobutrol or any component of the formulation, and in those with severe renal impairment (eGFR < 30 mL/min/1.73 m²) due to the risk of NSF. Caution is also advised in pregnant or breastfeeding women unless the benefit justifies the potential risk.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Gadobutrol
Route
Intravenous Use
Manufacturer
Bayer Plc
Origin
EU

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