Xenetix 350 Injection Solution

Description

Composition

The primary active ingredient in Xenetix 350 is Iobitridol. Each milliliter (mL) of the injection solution contains 767.8 mg of Iobitridol. In addition to Iobitridol, the solution includes several auxiliary substances such as sodium, calcium edetate, trometamol, trometamol hydrochloride, sodium hydroxide or hydrochloric acid (as pH balancers), and water for injection.

Indications

Xenetix 350 is indicated for use in enhancing the contrast of images obtained during various radiological examinations. This improved contrast aids in the clear visualization and delineation of body structures, which is crucial for accurate diagnosis. It is particularly used in computed tomography (CT) scans and other types of radiographic studies.

Contraindications

Xenetix 350 should not be used in the following conditions:

• Allergy to Iobitridol or any other components of Xenetix.
• Previous allergic reaction to Iobitridol.
• Hyperthyroidism (excess thyroid hormones).
• Pregnancy, particularly if undergoing hysterosalpingography (examination of the uterus and fallopian tubes).

Warnings and Precautions

Before using Xenetix 350, inform your healthcare provider if:

• You have a history of allergic reactions to contrast agents.
• You are asthmatic and have had a recent asthma attack.
• You have a history of allergies.
• You suffer from sickle cell disease.
• You have any conditions that could lead to an imbalance in water or electrolytes, such as dehydration or hypernatremia.

Common Side Effects

Like all medications, Xenetix 350 can cause side effects, although not everyone will experience them. Commonly reported side effects include:

Category	Side Effect
Allergic Reactions	Angioedema (rare): Swelling of the face, tongue, or throat, hives, difficulty breathing. Allergic shock reaction (very rare): Severe allergic reaction, potentially life-threatening.
Respiratory Issues	Rhinitis, shortness of breath, cough, difficulty swallowing, apnea, bronchospasm, laryngeal edema.
Other Side Effects	Fatigue, headache, low blood pressure, abnormal heart rhythms (fast or slow heart rate), cardiac arrest, stomach ache, nausea.

If you experience any side effects, contact your healthcare provider immediately. Always seek professional advice for personalized information.

Storage

For storage instructions, refer to the package leaflet or consult with your doctor or pharmacist. Generally, medications should be kept out of reach of children and stored in their original packaging.

Administration of Xenetix 350 Injection Solution

Method of Administration

Xenetix 350 is administered via injection under the supervision of a doctor. A plastic needle will be left in your vein, allowing the doctor to administer appropriate emergency drugs if necessary. If an allergic reaction occurs, the administration of Xenetix will be halted.

Route of Administration

Xenetix 350 can be administered intravenously (intravascular route) or injected into a body cavity (intra-articular or intra-uterine route) depending on the type of examination.

Use of Auto-injector

For larger volumes, such as the 500 mL bottle or bag, an auto-injector is used. A sterile device, approved for repeated use, ensures the safe transfer of the contrast medium from the vial to the syringe.

Xenetix vs. Other Contrast Agents

Unique Chemical Structure

Xenetix is a non-ionic monomeric iodinated contrast agent with a unique chemical structure designed for stabilized hydrophilicity, potentially reducing interactions with proteins in cell membranes or plasma.

Low Osmolality and Viscosity

Xenetix features low osmolality and low viscosity, making it easier to inject and less likely to cause discomfort or complications at the injection site.

High Water Solubility

Xenetix has high water solubility, allowing it to dissolve easily in water, distribute evenly in the body, and provide clear, high-quality images.

Safety Profile

The safety profile of Xenetix is comparable to other non-ionic, water-soluble, tri-iodinated, low-osmolality contrast media, with similar risks and side effects.

Xenetix vs. Other Iodinated Contrast Agents

Chemical Structure and Composition

Xenetix, like other iodinated contrast agents, contains iodine, which is essential for enhancing image contrast. The active ingredient, Iobitridol, is used in concentrations and volumes similar to other iodinated X-ray contrast agents.

Safety Profile

The safety profile of Xenetix aligns with that of other non-ionic, water-soluble, tri-iodinated, low-osmolality contrast media, with comparable risks and side effects.

Dosage and Administration

The dosage of Xenetix varies depending on the examination type, patient age, weight, cardiac output, and general condition. The lowest effective dose necessary to achieve adequate visualization should be used.

Contraindications

Xenetix should not be used in patients with hypersensitivity to Iobitridol or any of its excipients, history of severe skin reactions to Xenetix, or manifest thyrotoxicosis.

Benefits of Xenetix 350 Injection Solution

Diagnostic Agent

Xenetix 350 is an essential diagnostic agent used in radiological examinations, aiding in the accurate diagnosis of various medical conditions.

Enhances Image Contrast

Xenetix significantly enhances the contrast of radiological images, improving the visualization and delineation of body structures, which is critical for detecting abnormalities.

Wide Range of Applications

Xenetix is approved for use in both adults and children for various indications, including intravenous urography, head and whole-body CT, and digital subtraction angiography.

Safety Profile

Clinical safety has been demonstrated through Real World Evidence, with extensive post-marketing surveillance studies and clinical trials indicating that Xenetix is generally well-tolerated.

Mechanism of Action of Xenetix 350 Injection Solution

Introduction

Xenetix 350 is an iodine-based contrast agent used in X-ray imaging. The active ingredient, Iobitridol, belongs to the class of iodinated contrast agents.

Mechanism of Action

Xenetix works by altering the concentration of certain endogenous factors, enhancing image contrast during radiological examinations, and improving the delineation of body contours.

Distribution and Elimination

After intravascular injection, Iobitridol is distributed through the vascular system and interstitial spaces, and it is rapidly eliminated by the kidneys. In cases of renal failure, it is excreted via the biliary route.

Table: Xenetix 350 Overview

Category	Details
Composition	Active Ingredient: Iobitridol (767.8 mg/mL)
Indications	Enhances image contrast in radiological examinations
Contraindications	Allergy to Iobitridol, previous allergic reaction to Iobitridol, hyperthyroidism, pregnancy
Warnings	Allergic history, asthma, sickle cell disease, electrolyte imbalance
Side Effects	Allergic reactions, respiratory issues, fatigue, headache, low blood pressure, cardiac issues
Storage	Refer to package leaflet, keep out of reach of children
Administration	Injection (intravascular, intra-articular, intra-uterine)
Benefits	Enhances image contrast, wide application range, proven safety
Mechanism	Alters endogenous factors to improve image contrast
Elimination	Rapid renal elimination, biliary route in renal failure

This comprehensive overview of Xenetix 350 Injection Solution highlights its composition, indications, contraindications, administration methods, side effects, benefits, and mechanism of action, emphasizing its crucial role in diagnostic imaging.