Telebriks 30 meglumine - instructions for use, doses, side effects, contraindications

Active substanceYoksitalamic acidYoksitalamic acid

Similar drugsTo uncover

Telebriks® 30 meglumine

solution in / in v / vesular

Gerbe France

Telebriks® 35

solution in / in

Gerbe France

Dosage form: & nbspsolution for intravenous and intravesical administration

Composition:

1 ml of the solution contains:

Active substance:
Meglumine yoxitalamata	660.3 mg
that corresponds to Yoda	300 mg
Excipients:
Sodium calcium edetate	0.086 mg
Sodium dihydrogen phosphate dihydrate	0.50 mg
Water for injections	up to 1ml

Pharmacotherapeutic group:radiopaque

ATX: & nbsp

V.08.A.A Water-soluble high osmolarity radiopaque substances for the study of the kidneys

Pharmacodynamics:

Telebriks® 30 meglumine contains meglumine yoxythalamate, which is a water-soluble salt of triiodobenzoic acid and is a product of the interaction of the active substance of yoxythalamic acid and meglumine auxiliaries.

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. The volume of 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_1/213.1 min (in women) and 23.5 min (in males) passes into the elimination phase with T_1/2102 min (in women) 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.

Contraindications:

- Subarachnoidal administration of the drug;

- thyrotoxicosis;

hypersensitivity to the components of the drug.

Carefully:

TelebriX® 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 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 drug during pregnancy is justified.

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

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.

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.

Dosing and Administration:

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.

In the course of retrograde urethrocystography and suprapubic cystography, the dose is selected depending on the volume of the bladder, taking into account the age, body weight, vessel size and blood flow velocity.

If a side effect develops during the administration, the injection should be stopped immediately.

IV excretory urographyI (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 computed 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 effects:

Adverse reactions may develop in the early stages, but may be deferred.

Reactions of mild to moderate severity, manifested immediately after the administration of the drug can manifest themselves either individually or in combination and are as follows:

symptoms on the part of the respiratory system: cough, chest tightness;

symptoms from the gastrointestinal tract: nausea, vomiting;

neurosensory symptoms: 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 side effects reactions, or simultaneously with them may arise more serious:

allergic reactions: shortness of breath, lower 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;

ventilation disorders: shortness of breath, laryngeal edema, bronchospasm;

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

Accidental ingestion of the drug in the surrounding tissue can cause local soreness and an inflammatory response.

Therapy with adverse reactions

For mild to moderate adverse reactions:

- stop the injection;

- monitor the pulse and blood pressure;

- if necessary, administer antihistamines, drugs and glucocorticosteroids; possibly, 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 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.

Disturbances of ventilation:

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

Neurological disorders:

Attacks of tetanic convulsions usually cease after exhalation in a bag (breathing in a closedcontour) 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 drug, extravasal administration of the drug requires non-specific local events and monitoring the skin condition.

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.

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 with the administration of yoxythalamic acid, 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, this increases the risk of developing acute renal failure, especially when using large doses of yoxythalamic acid. Before the administration of the drug containing yoxitalamic acid, the patient should be rehydrated

- Metformin

In patients with diabetes mellitus, a decrease in renal function caused by X-ray examination may be a trigger factor in 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 reaction to administer the drug 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.

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 measures,especially if the patient receives beta-blockers, or he has a pheochromocytoma or a suspicion of it.

Radioisotope thyroid scans or radio therapyactive iodine 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.

Effect on the ability to drive transp. cf. and fur:

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

Form release / dosage:

Solution for intravenous and intravesical administration, 300 mg iodine / ml.

Packaging:

For 30, 50 or 100 ml in glass bottles (type II), sealed with butyl rubber stoppers, crimped with aluminum caps with plastic lids. Bottles of 100 ml are graduated in ml and are covered transparent film with a holder at the bottom of the vial (the label of the vial is pasted over the film, it is graded), or the label has a detachable part used as a holder.

1 bottle is placed in a cardboard box together with instructions for use.

For 1 bottle of 50 ml with a sterile syringe and a microinfusion is placed in a cardboard pack together with instructions for use.

Packing for hospitals:

For 25 bottles of 30 and 50 ml and 10 bottles of 100 ml are placed in a cardboard box with an equal number of instructions for use.

Storage conditions:

Store at a temperature of no higher than 30 ° C, in a place protected from light.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the date shown on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N010125

Date of registration:21.10.2011

The owner of the registration certificate:GerbeGerbe France

Manufacturer: & nbsp

GUERBET France

Representation: & nbspNGO ASTA, CJSCNGO ASTA, CJSCRussia

Information update date: & nbsp12.11.2015

Illustrated instructions

Instructions

Telebriks® 30 meglumine (Telebrix® 30 meglumine)