Novatrizoat (Solution) Instructions for Use

Instructions
Dosage forms

ATC Code

V08AA01 (Amidotrizoic acid)

Active Substance

Sodium amidotrizoate (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Radiocontrast ionic diagnostic agent for intravascular and intracavitary administration

Pharmacotherapeutic Group

Radiocontrast agent

Pharmacological Action

Radiocontrast diagnostic agent containing iodine. It enhances image contrast by absorbing X-rays with iodine.

Indications

Employ this ionic iodine-based contrast agent for a range of diagnostic imaging procedures to enhance radiographic visualization.

Conduct intravenous urography and retrograde urography for evaluation of the renal collecting system, ureters, and bladder.
Perform angiocoronarography for visualization of the coronary arteries.
Utilize for opacification of body cavities during computed tomography (CT) and for hysterosalpingography to assess the uterine cavity and fallopian tubes.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
Z03	Medical observation and evaluation for suspected disease or pathological condition

ICD-11 code	Indication
QA02	Medical observation or examination for suspected diseases or conditions that were ruled out

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Establish the dosage and concentration individually for each patient, based on the specific diagnostic procedure, the vascular or cavity being examined, and the patient’s body weight, age, and renal function.

Administer the solution via the appropriate route, such as intravenous injection for urography or direct intracavitary instillation for other studies. Use only the 76% concentration formulation for coronary angiography procedures.

Solution

It is established individually, depending on the indications and the dosage form used.

Adverse Reactions

Monitor patients for immediate and delayed hypersensitivity reactions. Nausea and vomiting are common gastrointestinal effects.

Observe for signs of allergic reactions, ranging from urticaria and angioedema to bronchospasm, anaphylactic shock, and cardiovascular collapse, particularly in patients with a known predisposition.

Be aware of other potential effects, including dizziness, sensation of heat, facial flushing, cyanosis, and pain at the injection site. Severe renal impairment or failure is a risk, especially in patients with pre-existing renal disease.

Contraindications

Do not administer this preparation under any circumstances to patients with specific, absolute contraindications to its use.

Absolute contraindications include documented hypersensitivity to iodine or the drug itself, severe hyperthyroidism, significant cardiac impairment such as decompensated heart failure, severe myocardial lesions, and states of shock or collapse.
Also contraindicated are severe hepatic or renal insufficiency, active tuberculosis, pulmonary emphysema, severe arterial hypertension, and acute phlebitis when phlebography is intended.
Relative contraindications (require careful risk-benefit assessment) include pregnancy, cerebral atherosclerosis, decompensated diabetes mellitus, hypercoagulability, mild nodular goiter, plasmocytoma, and a severely debilitated general patient condition.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy.

Use in Hepatic Impairment

Contraindicated in severe hepatic insufficiency.

Use in Renal Impairment

Contraindicated in severe renal insufficiency.

Special Precautions

For coronary angiography, only the 76% solution is used.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Novatrizoat [Jodas Expoim, LLC (Russia)]
Injection solution 600 mg/ml: 20 ml, 50 ml, 100 ml or 200 ml fl. 1 or 10 pcs.

Marketing Authorization Holder

Jodas Expoim, LLC (Russia)

Manufactured By

Jodas Expoim, Pvt. Ltd. (India)

Dosage Form

Novatrizoat

Injection solution 600 mg/ml: 20 ml, 50 ml, 100 ml or 200 ml fl. 1 or 10 pcs.

Dosage Form, Packaging, and Composition

Injection solution transparent, colorless or slightly yellowish.

	1 ml*
Meglumine amidotrizoate	521 mg
Sodium amidotrizoate	79 mg

* – iodine concentration 292 mg/ml.

Excipients: sodium calcium edetate 0.1 mg, sodium hydroxide to pH 6.0 – 7.7, water for injections up to 1 ml.

20 ml – bottles (1) – cardboard boxes.
20 ml – bottles (10) – cardboard boxes.
50 ml – bottles (1) – cardboard boxes.
50 ml – bottles (10) – cardboard boxes.
100 ml – bottles (1) – cardboard boxes.
100 ml – bottles (10) – cardboard boxes.
200 ml – bottles (1) – cardboard boxes.
200 ml – bottles (10) – cardboard boxes.

Novatrizoat [Jodas Expoim, LLC (Russia)]
Injection solution 760 mg/ml: 20 ml, 50 ml, 100 ml or 200 ml fl. 1 or 10 pcs.