MRI Contrast Media

agnetic resonance imaging Contrast Media (MRI Contrast Media), also called Magnetic resonance imaging Contrast Agents, which is Gadolinium based contrast agent (GBCA), mainly refers to: after being introduced into the body through a certain way (generally intravenous injection), the MRI contrast media can produce more obvious image contrast between interest range and surrounding tissues. Different from the iodinated Contrast Media of CT/X-ray, the MR Contrast Mediaacts indirectly by affecting the proton relaxation time of the molecule. When entering the blood vessels and tissues of the contrast agent gadoliniumin the body, the MRI contrast media can shorten the relaxation time of T1 to enhance image contrast. The classic Contrast Media for MRI has wide indications, high detection rate, high safety and cost-effectiveness.

Types of MRI Contrast Media

Gadopentetate Dimeglumine Injection/API

Gadopentetate Dimeglumine Injection is the first domestic Gadolinium Contrast Media launched in China by Beilu Pharma in 1992. It has the same safety efficacy as the original product, but more cost-effective. Beilu Pharma offer linear and macrocyclic gadolinium based contrast agentswith specifications of 469mg/ml 10ml, 12ml, 15ml, 20ml.

Gadobutrol Injection/API

Gadobutrol Injection is a Macrocyclic Gadolinium Contrast Media, which is more stable and not easy to release gadolinium linear vs macrocyclictype Contrast-enhanced magnetic resonance imaging ( MRI ) of the brain and spinal cord, and contrast-enhanced magnetic resonance angiography ( CE-MRA ). Beilu Pharma offer products with specifications of 604.72mg/ml 7.5m.

Gadobenate Dimeglumine Injection

Paramagnetic Contrast Media for diagnostic magnetic resonance imaging ( MRI ) of the liver and central nervous system. Beilu Pharma offer 10ml specification.

Ferric Ammonium Citrate Effervescent Granules

Oral magnetic resonance Contrast Media. This type of MRI intravenous contrastmedia can significantly improve the images quality of MRCP and MRU, and can also be used as a positive contrast agent for the digestive tract. Beilu Pharma offer specifications: 3g: 0.6g ( Fe 129mg ), 6g: 1.2g ( Fe 258mg ).

Safety of Gadolinium Contrast Media

Acute reactions

Gadolinium Contrast Media possess a very low incidence ( < 2.5 % ) of acute adverse reactions compared to many other drugs. Almost all of their reactions are very mild, the most common are nausea, headache, discomfort at the injection site, vomiting, metallic taste, paresthesia, fever and dizziness.

Immediate hypersensitivity reactions may occur within 1 hour of imaging agents administration, it is approximately 1 in 1000 cases. These are more likely to occur in patients with allergies, asthma, and allergic reactions to gadolinium contrast agents. The most common of these reactions are mild pruritus ( itching ) and urticarial ( hives ). The moderate hypersensitivity reactions occur in about 1 in 5000 cases, it usually includes bronchospasm, facial oedema, arrhythmias, laryngospasm, tachycardia, or widespread urticarial(hives).

The incidence of severe reactions is about 1 in 20,000. A number of severe anaphylactoid reactions to Gd MRI Contrast Media, including death, have been reported worldwide, the risk of death is about 1 in 400,000.

Chronic ReactionsMRI Contrast Media-Chronic reactions

NSF ( Nephrogenic Systemic Fibrosis ) is the most famous of Chronic reactions to Ga Contrast Media. It is a disease of fibrosis of the skin and internal organs, which occurs in patients with chronic severe renal insufficiency. Several hundred patients have been diagnosed worldwide since the first reported case in 2006. NSF has now been largely eliminated as an existing disease with the efforts of the biology community. However, Gd-containing plaques in the extremities have been reported and may represent a forme fruste of NSF.

The US FDA believes that although medical literature reports that there is the deposition of gadolinium types-containing Contrast Media in the brain tissue of some patients undergoing 4 or more MRI scans, so far, there are no harmful symptoms, signs, and pathological changes appearing associated with the gadolinium-based contrast agent deposition in brain tissue. In its database of adverse event reporting system, the FDA has received many adverse event reports of patients experiencing pain or other symptoms after single or multiple applications of gadolinium-containing Contrast Media. However, so far, the FDA hasn't been able to clarify common features in these reports. It is not proven yet that the reported symptoms are reasonably related to gadolinium. Further information is needed to evaluate the possible risks caused by gadolinium deposition.

In conclusion, although the incidence of adverse reactions of the gadolinium Contrast Media used in the MRI enhancement examination is very low, one should always keep in mind that any drug administration carries with it the risk of life-threatening reaction, and long-term risks of gadolinium contrast medium deposition must be considered.

Founded in 1992, Beijing Beilu Pharmaceuticals Company Limitedis mainly engaged in the research & development, production and sales of pharmaceutical products. It is high-tech innovation company with core competence in the Contrast Media domestic. Beilu provides complete contrast media in CT scanproducts suitable for X-Ray and Magnetic Resonance Imaging (MRI), and it is the leading manufacturer in the Contrast Media field in China.

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