Telebrix 30 Meglumine (Solution) Instructions for Use

Marketing Authorization Holder

Guerbet (France)

ATC Code

V08AA05 (Ioxitalamic acid)

Active Substance

Ioxitalamic acid (Rec.INN registered by WHO)

Dosage Form

Telebrix 30 Meglumine

Solution for intravenous and intravesical administration 300 mg iodine/ml: fl. 30 ml, 50 ml or 100 ml 1 pc., fl. 50 ml in a set with a syringe and a microinfuser

Dosage Form, Packaging, and Composition

Excipients : sodium calcium edetate – 86 mg, sodium dihydrogen phosphate dihydrate – 500 mg, water for injections – up to 1 ml.

30 ml – glass bottles (1) – cardboard packs.
50 ml – glass bottles (1) – cardboard packs.
50 ml – glass bottles (1) in a set with a syringe and a microinfuser – cardboard packs.
100 ml – glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Radiocontrast non-ionic diagnostic agent for intravascular and intracavitary administration

Pharmacotherapeutic Group

Radiocontrast agent

Pharmacological Action

Telebrix 30 Meglumine contains meglumine ioxitalamate, which is a water-soluble salt of triiodobenzoic acid and is a product of the interaction of the active substance ioxitalamic acid and the excipient meglumine.

The drug has high osmolality: 1710 mosm/kg.

Non-ionic water-soluble triiodinated radiocontrast agent for intravenous and intravesical administration. It opacifies vessels along the path of distribution.

Pharmacokinetics

After intravascular administration, the drug is distributed in the bloodstream and interstitial space.

The drug is not metabolized and is rapidly excreted by the kidneys unchanged via glomerular filtration.

The volume of distribution in women is 7.2 L, in men 10 L; total clearance 95.4 ml/min and 101 ml/min, renal clearance 89.4 ml/min and 94.9 ml/min, for women and men respectively.

The initial rapid distribution phase with T_1/2 13.1 min (in women) and 23.5 min (in men) transitions into the elimination phase with T_1/2 102 min (in women) and 137 min (in men).

Binding to plasma proteins is insignificant.

In patients with renal failure, the drug may be excreted through alternative routes – mainly through the biliary tract.

Indications

Radiographic examination

• Intravenous urography;
• Computed tomography;
• Phlebography;
• Retrograde urethrocystography or suprapubic cystography.

ICD codes

Dosage Regimen

For intravenous urography, the dose should be selected depending on the patient’s age, body weight and renal function: a dose of 1 to 2 ml/kg body weight is usually administered. Children weighing less than 20 kg are administered a dose of 2-3 ml/kg.

For retrograde urethrocystography or suprapubic cystography, the dose is selected depending on the volume of the urinary bladder, taking into account age, body weight, vessel size and blood flow velocity. If an adverse effect develops during administration, the injection should be stopped immediately.

Intravenous excretory urography (300 mg iodine/ml): 250-390 mg iodine/kg patient, total dose 100 ml.

Contrast enhancement for head computed tomography 100-200 ml (30-60 g iodine) for injection (300 mg iodine/ml) or 86-172 ml for injection (350 mg iodine/ml).

Contrast enhancement for body computed tomography by bolus, rapid infusion method or by a combination of these two methods: 50-200 ml (15-60 g iodine) for injection (300 mg iodine/ml), or 43-172 ml for injection (350 mg iodine/ml).

Total dose 200 ml. Maximum total iodine dose 86 g.

Adverse Reactions

Adverse reactions may develop early but can also be delayed.

Mild and moderate severity reactions, manifesting immediately after drug administration, may occur individually or in combination and consist of the following

Respiratory symptoms: cough, feeling of tightness in the chest.

Gastrointestinal symptoms: nausea, vomiting.

Neurosensory symptoms feeling of heat, anxiety, agitation, headache.

Skin symptoms: itching, localized or generalized urticaria, skin rash, eyelid edema.

Following these mild or moderate adverse reactions or simultaneously with them, more serious ones may occur

Allergic reactions: shortness of breath, decreased BP, less frequently – anaphylactic shock, bronchospasm, laryngeal edema, pulmonary edema and, in exceptional cases, angioedema.

Cardiovascular symptoms: arrhythmias, profuse sweating, pallor, cyanosis, in exceptional cases – heart failure and cardiovascular collapse

Ventilation disorders: shortness of breath, laryngeal edema, bronchospasm.

Neurological disorders: tetany, convulsions, cerebral edema, coma.

Accidental leakage of the contrast agent into the tissues surrounding the vessel may cause local pain and an inflammatory reaction.

Therapy for adverse reactions

For mild and moderately severe adverse reactions

• Discontinue drug administration
• Monitor pulse and blood pressure
• If necessary, administer antihistamines and glucocorticosteroids
• Possibly oxygen therapy.

These symptoms usually remain mild and are quickly relieved.

For serious reactions

• Discontinue drug administration and monitor respiratory and cardiovascular functions.

Cardiovascular disorders

Maintaining venous access during the examination procedure allows for infusion of large doses of glucocorticosteroids (1-2 g hydrocortisone). Simultaneously, oxygen therapy should be administered, vasopressors, plasma, electrolytes should be administered taking into account hemodynamic parameters. If symptoms worsen, intensive care in a specialized department must be provided.

Ventilation disorders

Rare breathing with inspiratory dyspnea, which is a manifestation of laryngeal edema, requires endotracheal intubation and administration of large doses of glucocorticoids.

Neurological disorders

Attacks of tetanic convulsions usually stop after breathing into a bag (closed-circuit breathing) or administration of calcium gluconate. Ordinary convulsions are relieved by intramuscular administration of diazepam.

Some of these symptoms may develop later (after 24-48 hours).

Extravasation of the drug

Due to the high osmolality of the contrast agent, in case of extravasal administration of the drug, non-specific local measures and monitoring of the skin condition are required.

Contraindications

• Thyrotoxicosis;
• Hypersensitivity to the components of the drug.

Subarachnoid administration of the drug is contraindicated.

Telebrix 30 Meglumine should be used with caution in

• History of allergic reactions (hay fever, urticaria, food and drug allergies), bronchial asthma;
• Hepatic and/or renal failure;
• Chronic heart failure or severe respiratory failure;
• Diabetes mellitus;
• Myeloma;
• Anuria;
• Pheochromocytoma;
• Pulmonary emphysema.

Use in Pregnancy and Lactation

Isolated iodine overload of the body after administration of a contrast agent may theoretically lead to impaired thyroid function in the fetus if the examination is performed after 14 weeks from the last menstrual period. However, given the reversibility of this effect and the expected benefit for the mother associated with a thorough examination for any pathology, performing the examination during pregnancy seems justified.

This approach applies to both the use of iodine-containing contrast agents and ionizing radiation.

Currently, there are no data on the use of the drug during breastfeeding, so breastfeeding should be discontinued for 24 hours in case of drug administration.

The drug should not be used in pregnant women except in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

Such an examination is prescribed by a doctor out of necessity.

Use in Hepatic Impairment

Use with caution in hepatic insufficiency.

Use in Renal Impairment

Use with caution in renal failure. It is recommended to maintain sufficient diuresis in patients with renal failure.

Pediatric Use

Can be used in children according to the dosage regimen. It is recommended to avoid dehydration before diagnostic examination, especially in infants, and it is necessary to maintain sufficient diuresis in young children.

Geriatric Use

It is recommended to maintain sufficient diuresis in elderly patients with atherosclerosis.

Special Precautions

The examination should be performed on an empty stomach and after determining serum creatinine concentration to adapt the dose in patients with suspected renal impairment.

Throughout the diagnostic procedure

• Medical supervision must be ensured
• Venous access should be maintained.

Caution should be exercised in patients with severe respiratory failure or chronic heart failure.

It is recommended to avoid dehydration before diagnostic examination, especially in infants, and to maintain sufficient diuresis in patients with renal failure, diabetes mellitus, myeloma, hyperuricemia, in young children and in elderly patients with atherosclerosis.

The existing risk of manifestation and development of adverse reactions dictates the need for equipment for emergency resuscitation measures, especially if the patient is receiving beta-blockers or has pheochromocytoma or suspected pheochromocytoma.

Radioisotope scanning of the thyroid gland or radioactive iodine therapy should be performed before urography or angiography, after which transient iodine overload of the body will occur. The iodine-binding capacity of thyroid tissue remains reduced for 2 weeks after drug administration.

Iodine-containing contrast agents can cause mild, serious and fatal adverse reactions, which often occur early but can sometimes be delayed. Currently, these reactions cannot be predicted by the results of an iodine sensitivity test or by other methods.

Administration of iodine-containing radiocontrast agents may exacerbate the symptoms of myasthenia gravis.

Administration of the drug in patients with pheochromocytoma may lead to the development of a hypertensive crisis.

The examination is performed on an empty stomach.

Effect on the ability to drive vehicles and operate machinery

The drug may affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions, so precautions must be taken.

Overdose

Cases of acute renal failure have been observed after administration of large doses of the drug to patients in a state of dehydration, or after administration of a large total dose. The functions of vital organs must be restored by emergency symptomatic treatment. Violation of water-electrolyte balance can be compensated by rehydration. It is recommended to monitor renal function parameters for three days. If rehydration and other necessary measures are ineffective, oliguria and anuria may require hemodialysis.

Drug Interactions

Drug combinations requiring precautionary measures

Drug combinations requiring caution

• Beta-blockers

In case of shock or decreased BP during administration of iodine-containing contrast, beta-blockers suppress compensatory reactions from the cardiovascular system.

Before performing a radiological examination, the use of beta-blockers should, if possible, be discontinued. If continuity of therapy is extremely important for the patient, appropriate resuscitation equipment should be kept ready.

• Diuretics

If diuretics have caused dehydration, this increases the risk of developing acute renal failure, especially when using large doses of iodine-containing contrast. The patient should be rehydrated before administration of iodine-containing contrast.

• Metformin

In diabetic patients, decreased renal function caused by radiological examination may be a trigger for the development of lactic acidosis. Metformin intake should be temporarily discontinued 48 hours before and resumed 2 days after the radiological examination.

Drug combinations to be considered

• Interleukin II

The risk of developing a reaction to contrast agent administration is increased if the patient has previously received intravenous interleukin II therapy: skin rash or, less frequently, decreased BP, oliguria and renal failure.

Storage Conditions

Store at a temperature not exceeding 30°C (86°F) in a light-protected place, out of reach of children.

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is dispensed by prescription.

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.