Generated automatically from the NAFDAC register, WHO alerts and community data as of today. This is not medical advice. Always follow your doctor or pharmacist.
From the official U.S. FDA label for gadobutrol, the active ingredient registered with NAFDAC.
Gadobutrol injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI): • To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients, including term neonates ( 1.1 ) • To assess the presence and extent of malignant breast disease in adult patients ( 1.2 ) • To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients, including term neonates ( 1.3 ) • To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). ( 1.4 ). …
The following clinically significant adverse reactions are discussed elsewhere in labeling: • Nephrogenic Systemic Fibrosis (NSF) [see Boxed Warning and Warnings and Precautions ( 5.2 )] . • Hypersensitivity reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] . • Acute Respiratory Distress Syndrome [see Warnings and Precautions ( 5.4 )] . • Gadolinium Retention [see Warnings and Precautions ( 5.5 )] . …
Gadobutrol injection is contraindicated in patients with history of severe hypersensitivity reactions to gadobutrol injection. History of severe hypersensitivity reaction to gadobutrol injection ( 4 )
• Hypersensitivity Reactions: Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, have occurred. Monitor patients closely during and after administration of gadobutrol injection. ( 5.3 ) • Acute Respiratory Distress Syndrome: For Patients demonstrating respiratory distress after administration, assess oxygen requirement and monitor for worsening respiratory function. ( 5.4 ) • Gadolinium Retention: Gadolinium is retained for months or years in brain, bone, and other organs. …
8.1 Pregnancy Risk Summary GBCAs cross the placenta and result in fetal exposure and gadolinium retention. The human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive (see Data ) . In animal reproduction studies, although teratogenicity was not observed, embryolethality was observed in monkeys, rabbits and rats receiving intravenous gadobutrol during organogenesis at doses 8 times and above the recommen …
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Gadovist 1.0 mmol/mL Injection contains Gadobutrol (1 mmol/mL), as solution for injection, according to its NAFDAC registration record.
Yes. Gadovist 1.0 mmol/mL Injection is listed on the NAFDAC register under registration number A4-5509, and its registration is active as of 28 October 2026.
No WHO falsified or substandard medical product alert currently matches Gadovist 1.0 mmol/mL Injection in our automatically synced alert list.
Run a free authenticity scan with the NAFDAC number A4-5509, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.
Gadobutrol injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI): • To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients, including term neonates ( 1.1 ) • To assess the presence and extent of malignant breast disease in adult patients ( 1.2 ) • To (Summarised from the official U.S. FDA label for gadobutrol. Always follow your doctor or pharmacist.)
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