Gastrografin Injection

1 Pharmacology The substance that produces the contrast effect in diatrizoate injection is a diatrizoate, in which the firmly bound iodine absorbs X-rays. 2 Toxicology Systemic toxicity Based on the results of acute toxicity studies, no risk of acute poisoning was found with the use of diatrizoate injection. Animal studies on systemic tolerance with repeated daily intravenous administration did not find any results that were unfavorable to the usually one-time diagnostic use in humans. Potential genotoxicity, carcinogenicity Studies on genotoxicity did not find diatrizoate to have a mutagenic effect in vivo or in vitro. Based on the above results, and taking into account the metabolic stability of diatrizoate and the one-time diagnostic use of diatrizoate injection, it is believed that diatrizoate injection has no carcinogenic risk to humans. Local tolerance and contact sensitization possibility Local tolerance studies did not show that diatrizoate injection had local adverse reactions to blood vessels, or mucous membranes or serosal membranes in the human body. Mild to moderate local intolerance reactions may occur if diatrizoate injection is accidentally injected into blood vessels or into other tissues.

The main ingredients and chemical names of this product are: Diatrizoate: 3,5-bis(acetylamino)-2,4,6-triiodobenzoic acid, dihydrate. Meglumine: 1-deoxy-1-(methylamino)-D-sorbitol.

1. Intravenous and retrograde urography; angiography of the brain, chest, abdomen and limbs, venography and CT. 2. Pan-diatrizoate injection should not be used for selective coronary angiography. 3. Pan-diatrizoate injection can also be used for arthrography, fistula angiography, hysterosalpingography, endoscopic retrograde cholangiopancreatography (ERCP), sialography and other examinations.

General Information Dietary Recommendations During abdominal angiography and urography, the absence of intestinal excreta and gas interference can improve the diagnostic effect. Patients should abstain from gas-producing foods from 2 days before the examination, especially peas, beans, lentils, salads, fruits, dark and fresh bread, and all uncooked vegetables. The day before the examination, patients should fast after 6 pm and take a laxative that night. However, neonates, infants and young children are contraindicated from fasting for a long time and using laxatives before the examination. Hydration Adequate water must be given before and after the use of contrast agents. This is especially true for patients with multiple myeloma, diabetes with nephropathy, polyuria, oliguria, hyperuricemia, as well as neonates, infants, young children and elderly patients. Before the examination, water and electrolyte imbalances must be corrected. Neonates (<1 month) and infants (1 month-2 years) and young infants (age <1 year), especially neonates, are prone to electrolyte imbalance and hemodynamic changes. Attention should be paid to: the dose of contrast agent given, the technical operation of the examination process and the patient's condition. Anxiety Excessive excitement, anxiety, and pain can increase the risk of adverse reactions or worsen reactions associated with contrast agents. Sedatives may be given to these patients. Warming before use Contrast agents that are warmed to body temperature before use are better tolerated and are easier to inject due to reduced viscosity. Warm the required number of bottles of contrast agent in an incubator to 37oC only on the day of the examination. If stored in the dark, heating for a longer period of time will not cause changes in its chemical purity. However, it should not exceed 3 months. Preliminary allergy testing with small doses of contrast agents is not recommended because it has no predictive value. In addition, allergy testing itself can occasionally cause severe and even fatal allergic reactions. Intravascular doses of contrast agents should be injected into the blood vessel with the patient supine as much as possible. After administration, the patient should continue to be observed for at least 30 minutes, as experience shows that most serious reactions occur during this time. The dose can be adjusted according to the patient's age, weight, cardiac output, and general condition. Patients with significant renal or cardiovascular insufficiency and those in very poor general condition must use the lowest possible dose of contrast agent. For these patients, monitoring of renal function for at least 3 days after the examination is recommended. Recommended dose: There are different opinions on the injection speed of contrast agent for intravenous urography. Generally, 30ml is used and the injection time is more than 2-3 minutes. According to the experience of many examiners, an injection time of about 1 minute can also be well tolerated. □ The adult dose is 30ml of diatrizoate injection. Increasing the dose to 60ml can significantly enhance the diagnostic effect. In special cases, if necessary, the dose can be further increased. The renal units of children and infants are not yet mature, and the concentration function of the kidney is poor under normal physiological conditions, so a relatively large dose of contrast agent is required: 8-12ml for children under 1 year old 12-15ml for 2-2 years old 15-20ml for 6-6 years old 20-25ml for 6-10 years old 10-15 years old 25-30ml □ Filming time Filming is performed immediately after the injection of contrast agent, which best shows the renal parenchyma. To observe the renal pelvis and ureter, take the first film 3-5 minutes after the injection of contrast agent, and take the second film 10-12 minutes. Young patients should take films earlier, while elderly patients should take films later. It is recommended that the first film be taken about 2 minutes after contrast injection for newborns, infants and young children. If the contrast is poor, the filming should be delayed. The amount of contrast for vascular imaging depends on the location of the blood vessel being examined. Due to differences in equipment and usage methods in various clinical units, specific data on the examination technology cannot be provided. Computerized X-ray Tomography (CT) Head CT Pan-diatrizoate injection is used for CT enhancement examination of head tumors and other lesions. The dose is 1-2 ml (maximum 2 ml) per kilogram of body weight, injected intravenously or infused within 2-6 minutes. Scan start time: Scan time after the contrast injection is completed (minutes) Arteriovenous malformations, aneurysms and other vascular diseases Immediately to 5 minutes Tumors with rich blood vessels can be up to 5 minutes or slightly later Tumors with poor blood vessels 10-15 minutes or more The time difference is based on the highest concentration of contrast agent in the blood immediately after injection and the time of highest concentration in each different lesion tissue. For slow scanners, it is recommended to inject 100 ml of contrast medium in two steps (the first 50 ml is injected over about 3 minutes, and the remaining 50 ml is injected over about 7 minutes) to achieve a relatively uniform (although not maximal) contrast concentration in the blood. Scanning should begin after the first injection is completed. Whole body CT The dose and injection rate of contrast medium required for whole body CT depend on the organ being examined, the diagnostic needs, and especially the different scanning and reconstruction time of the scanner used. Slow scanners are preferably drip-injected, while fast scanners are preferably bolus-injected. Abdominal CT The dose of contrast medium required for abdominal examinations varies greatly. When examining the liver, 80-100 ml of diatrizoate injection is required to be injected intravenously over 2-5 minutes, which can achieve good contrast enhancement in patients of normal weight. Retrograde urography of the body cavity Diluting 65% diatrizoate injection with approximately the same amount of injection water can obtain a solution of about 30%, which is usually sufficient for retrograde urography. It is recommended to warm the contrast medium to body temperature to avoid hypothermic stimulation and ureteral spasm. For special examinations, where a high contrast is required, the undiluted solution may also be used. Despite the high concentration, irritation has been observed extremely rarely. Other body cavity arthroscopic contrast, hysterosalpingography, and especially during endoscopic retrograde pancreaticobiliary contrast, the injection of contrast medium should be monitored by fluoroscopy.

To give an approximate figure for the incidence of adverse reactions, the following definitions apply where they appear below: - Common: incidence 31:100 - Uncommon: incidence 1:100 but 31:1000 - Rare: incidence 1:1000 Intravascular Use Adverse reactions associated with intravascular administration of iodinated contrast media are usually mild to moderate and transient. However, serious reactions and fatal reactions and deaths have been reported. The incidence of adverse drug reactions reported in patients receiving ionic contrast media is more than 12%, compared to more than 3% for non-ionic contrast media. Nausea, vomiting, pain and heat are the most common reactions. Anaphylactoid reactions/allergies Mild angioedema, conjunctivitis, cough, pruritus, rhinitis, sneezing and urticaria are commonly reported. These reactions may be a precursor to shock and are independent of the amount or route of administration of contrast media. In this case, the contrast medium injection must be stopped immediately and, if necessary, targeted intravenous therapy should be initiated. Severe reactions requiring emergency treatment may present with circulatory disturbances with peripheral vasodilation and secondary hypotension, reflex tachycardia, dyspnea, agitation, confusion and cyanosis that may lead to loss of consciousness. Hypotension, bronchospasm and laryngospasm or edema are uncommon. Delayed contrast reactions are rare. Systemic reactions Sensation of heat and headache are commonly reported. Malaise, chills or sweating and vasovagal reactions are uncommon. Changes in body temperature and salivary gland enlargement may occur in rare cases. Respiratory Common transient changes in respiratory rate, dyspnea, respiratory distress and cough. Respiratory arrest and pulmonary edema are rare. Cardiovascular transient changes in heart rate and blood pressure with clinical significance, disturbances in heart rhythm or function and cardiac arrest are uncommon. Severe reactions requiring emergency treatment may present with circulatory disturbances with peripheral vasodilation and secondary hypotension, reflex tachycardia, dyspnea, agitation, confusion and cyanosis that may lead to loss of consciousness. Serious thromboembolic events leading to myocardial infarction have been reported in rare cases. Gastrointestinal nausea and vomiting are common reactions. Abdominal pain is uncommon but has been reported. Cerebrovascular During cerebral angiography and other examinations, high concentrations of contrast medium in the arterial bloodstream entering the brain can be associated with transient neurological symptoms such as dizziness, headache, agitation or confusion, amnesia, speech, visual and auditory disturbances, convulsions, tremors, paresis/paralysis, photophobia, transient blindness, coma and somnolence are uncommon. In very rare cases, serious thromboembolic events leading to stroke have occurred, and even death in individual cases. Renal In rare cases, renal impairment or acute renal failure have been reported. Skin Mild angioedema, flushing reaction with vasodilation, urticaria, pruritus and erythema are common. Rarely, toxic skin reactions such as mucocutaneous syndrome (such as Stevens-Johnson's or Lyell syndrome) may occur. Local irritation (at the injection site) Local pain is common, primarily during peripheral angiography. Extravasation of contrast media, including diatrizoate meglumine injection, may cause local pain and edema, but usually resolves without sequelae. However, in very rare cases, inflammation and even tissue necrosis have occurred. Thrombophlebitis and venous thrombosis are uncommon. Intracavitary use Adverse reactions to contrast media are rare after intracavitary administration. Most reactions occur several hours after administration of contrast media due to slow absorption from the administration site and distribution throughout the body by diffusion-controlled processes. Elevated amylase levels are common after ERCP. Opacification of the acini after ERCP has been shown to be associated with an increased risk of post-ERCP pancreatitis. Rare cases of necrotizing pancreatitis have occurred. Vasovagal reactions associated with hysterosalpingography are uncommon. Anaphylactoid reactions/allergic Systemic allergic reactions are rare, most are mild and usually manifest as skin reactions. However, the possibility of severe allergic reactions cannot be completely ruled out. Please refer to the section on anaphylactoid reactions during intravascular use.

Patients with significant hyperthyroidism and decompensated heart failure are contraindicated. Hysterosalpingography is contraindicated during pregnancy or acute pelvic inflammation. Endoscopic retrograde cholangiopancreatography (ERCP) is contraindicated during acute pancreatitis. Diatrizoate meglumine injection should not be used for myelography, ventriculography, or cisternsography because it may induce neurotoxic symptoms.

Metformin therapy The use of intravascular X-ray contrast agents that are excreted by the kidneys can cause transient renal impairment. This can lead to lactic acidosis in patients taking biguanides. (As a precaution, biguanides should be discontinued 48 hours before contrast administration and should not be resumed until renal function has returned to normal at least 48 hours after contrast administration.) Patients receiving beta-blockers, especially those with bronchial asthma, may have exacerbated allergic reactions. In addition, it should be recognized that patients receiving beta-blockers may be insensitive to standard treatment of allergic reactions with beta-agonists. The incidence of late contrast reactions (such as fever, rash, flu-like symptoms, joint pain, and itching) is higher in patients receiving interleukin therapy. Interference with diagnostic examinations After the use of iodinated contrast agents, the ability of thyroid tissue to take up radioactive isotopes that diagnose thyroid abnormalities is reduced for up to 2 weeks, or even longer in some cases. Alcohol intoxication Acute or chronic alcohol intoxication can increase the permeability of the blood-brain barrier. This allows contrast agents to easily enter brain tissue, which may trigger central nervous system reactions. Alcoholics and drug addicts must be cautioned because of the possibility of a lowered seizure threshold.

Protect from light and ionizing radiation. Store below 30°C. Keep all medicines out of reach of children.

1ml:0.3g

Xi`an Han Feng Pharmaceutical Co., Ltd.

• Founded in:

  2003-03-11

• Address:

  No. 15, Wenji Road, Lantian County Industrial Park

• Tax NO.:

  91610122742829723D

• Registered Funds:

  25 million yuan

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