Universal reference book for medicines
Product name: TELEBRIX 30 MEGLUMINE (TELEBRIX 30 MEGLUMINE)

Active substance: ioxitalamic acid

Type: Radiopaque non-ionic diagnostic preparation for intravascular and intracavitary administration

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

meglumine yoxitalamate 660.3 mg,

which corresponds to the content of iodine 300 mg

[PRING] sodium calcium edetate - 86 mg, sodium dihydrogen phosphate dihydrate - 500 mg, water d / and - up to 1 ml.

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

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

50 ml - glass bottles (1) complete with a syringe and microinfusion - packs 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 30 meglumine contains meglumine yoxythalamate, which is a water-soluble salt of triiodobenzenic acid and is a product of the interaction of the active substance of yoxythalamic acid and the meglumine auxiliary.

The drug has a high osmolality: 1710 mosm / kg.

Nonionic water-soluble triiodinated radiocontrast agent for IV and IV infusion.
Contrasts the vessels on the path of spread.
PHARMACOKINETICS

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

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

Volume distribution in women 7.2 liters, in men 10 liters;
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 phase of rapid spread with T 1/2 of 13.1 min (in women) and 23.5 min (in males) passes into the elimination phase with T 1/2 102 min (in females) and 137 min (in males).

The connection with plasma proteins is negligible.

In patients with renal insufficiency, the drug can be excreted through alternative routes - mainly through the biliary tract.

INDICATIONS

Radiographic examination:

- intravenous urography;

- CT scan;

- phlebography;

- Retrograde urethrocystography or suprapubic cystography.

DOSING MODE

When carrying out intravenous urography, the dose should be chosen depending on the patient's age, body weight and kidney function: a dose of 1 to 2 ml / kg of body weight is usually administered.
Children with a body weight of less than 20 kg are given a dose of 2-3 ml / kg.
When performing retrograde urethrocystography or suprapubic cystography, the dose is selected depending on the volume of the bladder, taking into account age, body weight, vessel size and blood flow velocity.
If a side effect develops during the 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 with computed tomography of the head : 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 in computer tomography of the trunk: bolus, rapid infusion or 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).

The total dose of 200 ml.
The maximum total dose of iodine is 86 g.
SIDE EFFECT

Adverse reactions may develop early, but may be delayed.

Reactions of mild to moderate severity that occur immediately after the administration of the drug can occur both individually and in combination and are as follows:

Symptoms on the part of the respiratory system: cough, a feeling of tightness in the chest.

Symptoms from the gastrointestinal tract: nausea, vomiting.

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

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

Following these mild or moderate severity of adverse reactions, or simultaneously with them, more serious

Allergic reactions: dyspnea, lowering blood pressure, less often - anaphylactic shock, bronchospasm, laryngeal edema, pulmonary edema and, in exceptional cases, angioedema.

Cardiovascular symptoms: rhythm disturbances, profuse sweat, pallor, cyanosis, in exceptional cases - heart failure and cardiovascular collapse

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

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

Accidental entry of a contrast agent into the tissue surrounding the vessel can cause local soreness and an inflammatory response.

Therapy with adverse reactions

For mild to moderate adverse reactions:

- stop the injection of the drug

- monitor pulse and blood pressure

- if necessary, administer antithistamine drugs and glucocorticosteroids

- it is possible, oxygen therapy.

These symptoms usually remain mild and quickly stop.

In case of serious reactions:

- stop the introduction of the drug 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 glucocorticosteroid (1-2 g of hydrocortisone).
At the same time, oxygen therapy should be performed, vasopressors, plasma, electrolytes should be administered taking into account hemodynamic parameters. When the symptoms increase, intensive care should be provided in a specialized department.
Disturbances 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 glucocorticostrongs.

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

Extravasal drug exposure

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

CONTRAINDICATIONS

- thyrotoxicosis;

hypersensitivity to the components of the drug.

Contraindicated subarachnoidal administration of the drug.

Telebriks 30 meglumine should be used with caution when:

- presence in the anamnesis of allergic reactions (hay fever, hives, food and drug allergies), bronchial asthma;

- Hepatic and / or renal insufficiency;

- chronic heart failure or severe respiratory failure;

- Diabetes mellitus;

- myeloma;

- anuria;

- pheochromocytoma;

- emphysema of the lungs.

PREGNANCY AND LACTATION

Isolated overloading of the body with iodine after the administration of the contrast preparation can theoretically lead to a disruption of the thyroid function in the fetus if the examination is performed 14 weeks after the termination of menstruation.
However, given the reversibility of this effect and the expected benefit for the mother associated with a thorough examination of any pathology, the introduction of the examination during pregnancy seems justified.
This approach is applicable to both the use of iodine-containing contrast agents and ionizing radiation.

Currently, there is no data on the use of the drug in breastfeeding, so it is necessary to stop breastfeeding for 24 hours if the drug is administered.

The drug should not be used in pregnant women, except when the intended benefit to the mother from its use outweighs the potential risk to the fetus.

Such a study is appointed by the doctor because of necessity.

APPLICATION FOR FUNCTIONS OF THE LIVER

Use with caution in renal failure.
It is recommended to maintain sufficient diuresis in patients with renal insufficiency.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Use with caution in case of liver failure.

APPLICATION FOR CHILDREN

Possible use in children in accordance with the dosing regimen.
It is recommended to avoid dehydration before the diagnostic examination, especially in infants, and it is necessary to maintain sufficient diuresis in young children.
APPLICATION IN ELDERLY PATIENTS

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

SPECIAL INSTRUCTIONS

The examination should be performed in a state of fasting and after determining the serum creatinine concentration in order to adapt the dose in patients with suspected renal dysfunction.

Throughout the diagnostic procedure:

- it is necessary to provide medical supervision

- should be preserved venous access.

Care must be taken in patients with severe respiratory failure or chronic heart failure.

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

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

Radioisotope scans of the thyroid gland or radioactive iodine therapy should be performed prior to urography or angiography, after which there will be a transient overload of the body with iodine.
The iodine-binding capacity of the thyroid tissue remains reduced within 2 weeks after the administration of the drug.
Iodine-containing contrast agents can cause mild, severe and fatal side reactions that often occur early, but can sometimes be delayed.
At present, these reactions can not be predicted from the results of a sample for sensitivity to iodine or other methods.
The introduction of iodine-containing radiocontrast agents may aggravate the symptoms of myasthenia gravis.

With the introduction of the drug in patients with pheochromocytoma, the development of a hypertensive crisis is possible.

The study is performed on an empty stomach.

Impact on the ability to drive vehicles and manage mechanisms

Perhaps the effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions, so care must be taken.

OVERDOSE

After administration of large doses of the drug, patients who are in a state of dehydration, or after the administration of a large total dose, cases of acute renal failure were observed.
The functions of the basic vital organs should be restored by an emergency appointment of symptomatic treatment. Violation of the water-electrolyte balance can be compensated by conducting rehydration. It is recommended to monitor the parameters of kidney function for three days. If rehydration and other necessary measures are ineffective, oliguria and anuria may require hemodialysis.
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 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 2 days after the X-ray examination.
Combinations of drugs that should be taken into account

- Interleukin II

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

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

Store at a temperature not exceeding 30 ° C in a place out of the reach of children.
Shelf life - 3 years.

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