Gadobutrol Injection

Function and indication: This product is used for diagnosis and is for intravenous administration only. It is suitable for adults and children of all ages (including full-term newborns). (1) Contrast-enhanced magnetic resonance imaging (CE-MRI) examination of lesions in various parts of the body (including the brain and spinal cord). (2) Contrast-enhanced magnetic resonance angiography (CE-MRA) examination of various parts of the body.
Usage and Dosage: Gadobutrol injection should be administered by a physician with clinical experience in MRI. 1. Usage: Administer the required dose by intravenous bolus injection. MRI contrast-enhanced scanning can be started immediately after administration (the interval depends on the pulse sequence and examination plan used). Contrast-enhanced magnetic resonance angiography (CE-MRA) can observe the best imaging in the first arterial transit after the injection of gadobutrol injection. In cases of brain and spinal cord magnetic resonance imaging, the best imaging effect can be observed within approximately 15 minutes after the injection of gadobutrol injection (the interval depends on the type of lesion/tissue). Tissue enhancement usually lasts until 45 minutes after the injection of gadobutrol injection. T1-weighted scanning sequences are particularly suitable for contrast-enhanced examinations. When contrast agents are administered intravascularly, the patient should lie flat if possible. The patient should be observed for at least half an hour after the injection is completed, because experience with contrast agents shows that most adverse reactions occur during this period of time. 2. Dosage: The recommended adult dose for brain and spinal magnetic resonance imaging is 0.1mmol/kg body weight, equivalent to 0.1ml/kg body weight of 1.0M solution. If no abnormalities are found in the enhanced MRI scan and the clinic still highly suspects the presence of lesions, or more accurate information will affect the patient’s treatment, up to 0.2mmol/kg body weight of gadobutrol injection can be injected within 30 minutes after the first dose to improve the accuracy of diagnosis. Contrast-enhanced magnetic resonance angiography (CE-MRA) imaging of one observation field: for weight less than 75kg, use 7.5ml; for weight greater than or equal to 75kg, use 10ml (equivalent to 0.1-0.15mmol/kg body weight); for imaging of more than one observation field: for weight less than 75kg, use 15ml; for weight greater than or equal to 75kg, use 20ml (equivalent to 0.2-0.3mmol/kg body weight). 3. Children: For children who have not undergone electrocardiogram examination, the possibility of congenital long QT syndrome must be ruled out before administering gadobutrol injection. For the above indications, the recommended dose in children and adolescents aged 2 years and above is 0.1mmol gadobutrol injection/kg body weight (equivalent to 0.1ml/kg body weight). Doses of >0.1ml/kg body weight should not be given to children and adolescents. Due to the lack of data on efficacy and safety, gadobutrol injection is not recommended for patients under 2 years old. For detailed drug usage and dosage, please refer to the drug instructions.
Adverse reactions:
Adverse drug reactions reported in patients during clinical studies or post-marketing surveillance are as follows: 1. Immune system disorders: Rare: Hypersensitivity/anaphylactic reactions (e.g., anaphylactic shock, circulatory failure, respiratory arrest, pulmonary edema, bronchospasm, cyanosis, oropharyngeal swelling, laryngeal edema, hypotension, increased blood pressure, chest pain, urticaria, facial edema, angioedema, conjunctivitis, eyelid edema, flushing, sweating, coughing, sneezing, burning sensation, pallor, etc.) 2. Nervous system disorders: (1) Common: Headache. (2) Rare: Dizziness, taste disorder, paresthesia. (3) Rare: Loss of consciousness, convulsions, parosmia. 3. Heart disease: (1) Rare: Tachycardia, palpitations. (2) Unknown: Cardiac arrest. 4. Respiratory, chest and mediastinal disorders: Rare: Dyspnea. 5. Gastrointestinal disorders: (1) Common: Nausea. (2) Rare: Vomiting. (3) Rare: Dry mouth. 6. Skin and subcutaneous tissue diseases: (1) Rare: erythema, pruritus, rash. (2) Unknown: nephrogenic systemic fibrosis. 7. Systemic and administration site abnormalities: (1) Rare: hot sensation at injection site. (2) Rare: discomfort and cold sensation. For details on adverse drug reactions, please refer to the drug instructions.
Contraindications:
This product is contraindicated for patients who are allergic to the components of this product. Patients with a history of allergic reactions or suspected allergic reactions to other gadolinium chelates should not use this product.