Universal reference book for medicines
Product name: TELEBRIX 35 (TELEBRIX 35)

Active substance: ioxitalamic acid

Type: Radiopaque non-ionic diagnostic preparation for intravascular injection

Manufacturer: GUERBET (France)
Composition, form of production and packaging
Solution for intravenous administration of
1 ml

meglumine yoxitalamate 650.9 mg

sodium oxitholamate 96.6 mg,

which corresponds to the content of iodine 350 mg

50 ml - bottles of glass (1) - packs of cardboard.

100 ml - bottles of glass (1) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

Telebriks 35 is used for contrast enhancement when performing X-ray examinations of blood vessels, cavities of the heart and urinary tract.
Since the sodium content in this preparation is very close to the physiological concentrations of sodium in plasma (148 mEq / L), its use for these indications is justified.
PHARMACOKINETICS

After intravascular injection, the drug is distributed in the vascular bed and interstitial space.

The drug is not metabolized and is rapidly excreted through the kidneys in an unchanged form by glomerular filtration.

In patients with renal insufficiency, the drug can be excreted through alternative routes - mainly through the bile ducts, and to a lesser extent - through the salivary glands, sweat and large intestine.

INDICATIONS

Radiographic examination:

- intravenous urography,

- CT scan,

- digital angiography;

- angiocardiography (ventriculography, coronary angiography).

DOSING MODE

Ventriculography: 40 ml per injection (average).

Coronary angiography: 4 to 8 ml per injection.

The examination should be performed in a state of fasting and after the serum creatinine assay to adjust the dose in patients with suspected renal dysfunction.

If patients have hypersensitivity to iodine-containing contrast agents, as well as allergies in the anamnesis, which should be clarified by interviewing the patient, it is desirable to perform a premedication, which is usually effective (although it can not always prevent severe reactions).
Usually premedication includes the administration of antihistamines, glucocorticosteroids and, in some patients, fibrinolysis inhibitors (aminocaproic acid).
Currently, premedication is not considered necessary for all patients, as the percentage of adverse reactions is relatively small.

SIDE EFFECT

Adverse reactions may develop early, but may be delayed.
Such reactions can be mild, severe and even fatal.
1. Reactions of mild to moderate severity are characterized by the immediate appearance of the following disorders (both individually and in combination), not accompanied by severe cardiovascular disorders.

Disorders from the respiratory system: cough, a feeling of tightness in the chest.

Disorders from the gastrointestinal tract: nausea, vomiting.

Sensorine disorders: a feeling of heat, anxiety, agitation, headache.

Skin disorders: itching, localized or generalized urticaria, skin rash, edema of the eyelids.

These initial reactions are usually weakly expressed and rapidly disappear, but they can also be the first clinical signs of serious adverse events.

2. Serious or even fatal reactions (1: 20000 - 1: 120000) are characterized by an immediate start:

Cardiovascular disorders: Irradiating abdominal pain, arrhythmia, profuse sweating on the face and extremities, pallor, cyanosis, which may precede the development of shock with cardiovascular collapse or circulatory insufficiency, or acute pulmonary insufficiency, which can lead to death.

Disturbances of ventilation: shortness of breath, larynx edema, bronchospasm.

Neurological disorders: convulsions, cerebral edema, coma.

Some of these manifestations may develop delayed (up to 24-48 h).

CONTRAINDICATIONS

hypersensitivity;

- thyrotoxicosis.

Contraindicated use in myelography.

Telebriks 35 should be used with caution when:

- Hepatic and / or renal insufficiency;

- chronic heart failure;

- Diabetes mellitus;

- myeloma;

- anuria;

- pheochromocytoma;

- the presence of allergic reactions and conditions in the anamnesis (hay

fever, food allergy);

- bronchial asthma;

- emphysema of the lungs.

PREGNANCY AND LACTATION

When using the drug in pregnancy, cases of fetotoxicity are not described, however, in newborns there have been several cases of thyroid dysfunction.
But given the reversibility of this effect and the expected benefit for the mother associated with a thorough examination of any pathology, conducting an examination during pregnancy seems justified.
APPLICATION FOR FUNCTIONS OF THE LIVER

Use with caution in renal failure.
In patients with chronic renal failure in a state of dehydration, oliguria and anuria can develop. For this reason, these patients are advised to avoid limiting water intake prior to the examination and to maintain sufficient diuresis.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Use with caution in case of liver failure.

APPLICATION FOR CHILDREN

In infants in a state of dehydration, oliguria and anuria can develop.
For this reason, it is recommended that infants should avoid limiting water intake prior to the examination and maintain a sufficient diuresis.
SPECIAL INSTRUCTIONS

Iodine-containing contrast agents can cause mild, severe and fatal side reactions that often occur early, but can sometimes be delayed.
They are unpredictable, but more likely to occur in patients who have a history of allergic reactions and diseases: urticaria, bronchial asthma, eczema, hay fever, allergic reactions to food or medicines, or a history of increased sensitivity in an earlier survey using iodine-containing contrast agent. At present, these reactions can not be predicted from the results of a sample for sensitivity to iodine or other methods.
General Precautions:

It is recommended to be careful in patients with severe hepatic insufficiency, chronic heart failure, severe respiratory failure and anamnestic data on allergies or hypersensitivity to iodine.
Particular caution is required in patients with hyperthyroidism or benign nodular goiter.
Precautions associated with dehydration and kidney function in the patient.

Dehydration may be aggravated by
osmotic effect of these agents.
In patients with chronic renal failure, diabetes mellitus, myeloma, hyperuricemia, and in infants in a state of dehydration, oliguria and anuria can develop.
For this reason, these patients are advised to avoid limiting water intake prior to the examination and to maintain sufficient diuresis.
The introduction of large doses of radiopaque means with high speed to patients with chronic heart failure leads to a transient increase in the osmotic load on the circulation.
For this reason, these patients need monitoring for several hours to detect any delayed hemodynamic disorders.
Due to the risk associated with the use of the drug, the following is important during the diagnostic procedure:

- the doctor must provide constant medical supervision (in particular, for the frequency of heartbeats and arterial pressure);

- it is necessary to maintain venous access for emergency therapy of any adverse reactions.

In patients with pheochromocytoma or suspected of it before intravascular administration of the drug should be prepared appropriate resuscitation equipment.

Indicators of thyroid function:

if it is necessary to determine the function of the thyroid gland, the examination should be performed before angiography, since the latter leads to a transient massive overload of the body with iodine, which suppresses the iodine clearance in the thyroid gland and the absorption of radioactive iodine for a period of not less than 1 week.

Determination of protein in urine using strong acids after the use of triiodinated water-soluble contrast agents may give a false positive result.

Therapy at the onset of adverse reactions or reabsorption

For mild to moderate adverse reactions:

- stop the introduction of contrast;

- monitor the pulse and blood pressure;

- if necessary, administer antihistamines and glucocorticosteroids, and also start oxygen therapy.

In case of serious reactions:

- stop the introduction of contrast and monitor the function of breathing and cardiovascular system.

Cardiovascular disorders

Preservation of venous access during the examination procedure allows the infusion of large doses of glucocorticosteroids (1-2 g of hydrocortisone).
Simultaneously it is necessary to carry out oxygen therapy, to introduce vasopressors, plasma, electrolytes taking into account the parameters of hemodynamics.
When the symptoms increase, intensive care should be provided in a specialized department.

Disturbance of ventilation

Rare breath with inspiratory dyspnea, which is a manifestation of the laryngeal edema, requires endotracheal intubation and the administration of large doses of glucocorticoids.
At attacks of a bronchial asthma it is necessary intravenous introduction of glucocorticoids and / or bronchodilators.
Neurological disorders

Attacks of tetanic convulsions usually terminate after exhalation in a bag (respiration in a closed loop) or the administration of calcium gluconate.
Conventional cramps are stopped by intramuscular injection of diazepam.
Renal damage

If rehydration and other necessary measures prove ineffective, oliguria and anuria may require dialysis.

OVERDOSE

The administration of excessive doses to patients in a state of dehydration or the administration of a large total dose, especially after several injections during an angiographic examination (the doses introduced during trial injections must also be taken into account) contribute to the development of acute renal failure with oliguria or anuria.

If rehydration and other necessary measures prove ineffective, oliguria and anuria may require dialysis.

DRUG INTERACTION

Combinations of drugs that require precaution:

Combinations of drugs that require caution:

- Beta-blockers

In the case of development of shock or a pronounced decrease in blood pressure when iodine-containing contrast is introduced, beta-adrenoblockers suppress compensatory reactions from the cardiovascular system.

Before the X-ray examination, the use of beta-blockers should be stopped, if possible.
If continuity of therapy is extremely important for the patient, you should have appropriate resuscitation equipment at hand.
- Diuretics

If diuretics caused dehydration, it increases the risk of developing acute renal failure, especially when using large doses of iodine-containing contrast.
Before the introduction of iodine-containing contrast, the patient should be rehydrated.
- Metformin

In patients with diabetes mellitus, a decrease in renal function caused by an X-ray examination may be a triggering factor for the development of lactic acidosis (lactic acidosis).
Metformin should be temporarily discontinued 48 hours before and resumed only 2 days after the X-ray examination.
Combinations of drugs that should be taken into account:

- Interleukin II

The risk of developing a reaction to the administration of contrast agents is increased if the patient previously received intravenous therapy with interleukin II: a skin rash or, more rarely, a decrease in blood pressure, oliguria, and even kidney failure.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

Store at a temperature of no higher than 30 ° C in a dark place.
Keep out of the reach of children. Shelf life - 3 years.
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