Xenetics - instructions for use, dose, side effects, contraindications

Active substanceIobitridolIobitridol

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solution in / in

Gerbe France

Dosage form: & nbspsolution for intravenous administration

Composition:

1 ml of the solution contains:

Active substance:
Iobitridol	658.1 mg	767.8 mg
which corresponds to iodine	300 mg	350 mg
Excipients:
Disodium Calcium Edetate	0.1 mg	0.1 mg
Tromethamine hydrochloride	2.68 mg	2.68 mg
Tromethamine	0.364 mg	0.364 mg
Hydrochloric acid	up to pH 7.3	up to pH 7.3
Sodium hydroxide	up to pH 7.3	up to pH 7.3
Water for injections	up to 1 ml	up to 1 ml

Description:A clear, colorless or light yellow solution.

Pharmacotherapeutic group:X-ray contrast medium

ATX: & nbsp

V.08.A Radiocontrast iodine-containing substances

Pharmacodynamics:

Xenetics contains the active substance ibitritridol, which is a non-ionic water-soluble iodine-containing radiocontrast agent with low osmolarity for urography and angiography. Iobitridol characterized by a balanced and stabilized hydrophilicity.

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 unchanged by glomerular filtration without reabsorption or tubular secretion.In patients with renal insufficiency, the drug can be excreted through alternative routes - mainly through the biliary tract. Is amenable to dialysis.

Due to an increased and stable hydrophilicity does not penetrate the BBB and has very short half-life: at least 2 hours, fully drug excreted by the kidneys for 8 hours (at analogues - 24 hours), does not inhibit the renal function even in patients with renal insufficiency, particularly recommended for children.

Stabilized hydrophilicity of the drug leads to increased safety due to a decrease in the number of interactions in the biological environment; low binding to proteins; absence of vacuolization of renal cells; absence of epileptogenic activity; good tolerability of the cardiovascular system; high image quality and optimal diagnostic information.

Indications:

Xenetics® 300 mg iodine / ml and 350 mg iodine / ml:

- intravenous urography;

- computed tomography of the skull and the whole body;

- intravenous angiography;

- arteriography;

- Angiocardiography (in children the drug is used in a dose of 350 mg iodine / ml).

Contraindications:

Contraindicated subarachnoidal administration of the drug, as well as the use of the drug in the presence of a history of hypersensitivity and severe thyrotoxicosis.

When carrying out angiocardiography in children, the drug is used only at a dose of 350 mg iodine / ml.

Carefully:

Xenetics® should be used with caution when:

- presence in the anamnesis of allergic reactions and diseases (bronchial asthma, hay fever, urticaria, food and drug allergy);

- sugar diabetes;

- renal and/or hepatic insufficiency;

- myeloma;

- hyperuricemia;

- survey elderly patients from atherosclerosis.

Pregnancy and lactation:

The safety of the drug in pregnant women is not proven, although the results of the study in animals have not revealed a teratogenic effect in the preparation. The drug should not be used in pregnant women, unless the intended benefit to the mother from its use outweighs the potential risk to the fetus, and such a study is prescribed by the doctor as necessary.

Studies related to the isolation of the drug with human milk, was not conducted,in connection with which the use of the drug during lactation is not recommended. The results of the study on animals show a low degree of excretion with mother's milk (3%).

Dosing and Administration:

When carrying out intravenous urography, the dose should be chosen depending on the patient's age, body weight and kidney function.

Xenetics® 300 mg iodine / ml:

Indications	The average dose, ml / kg body weight	Overall volume (min-max)
Urography:
- rapid intravenous administration	1,2	50-100
- slow intravenous administration	1,6	100
CT scan:
- brain	1,4	20-100
- bodies	1,9	20-150
Intravenous digital	1,7	40-270
angiography
Arteriography:
- cerebral	1,8	45-210
- lower limbs	2,8	85-300
Angiocardiography	1,1	70-125

Xenetics® 350 mg iodine / ml:

Indications	The average dose,	Overall volume
	ml / kg body weight	(min-max)
Urography:	1,0	50-100
CT scan:
- brain	1,0	40-100 90-180
- bodies	1,8	40-100 90-180
Intravenous digital angiography	2,1	95-250
Arteriography:
- peripheral	2,2	105-205
- lower limbs	1,8	80-190
- abdominal cavity	3,6	155-330
Angiocardiography:
- adults	1,9	65-270
- children	4,6	10-130

Side effects:

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 from the gastrointestinal tract: nausea, vomiting.

Symptoms from the nervous system: feeling of heat, anxiety, agitation, headache.

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

Following these mild or moderate degrees of adverse reactions, or simultaneously with them, more serious can occur from different organs and systems: skin, respiratory, nervous, digestive and cardiovascular systems, up to a collapse of varying severity, as well as shock and ( or) cardiac arrest.

Allergic reactions: shortness of breath, depression of 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, swelling of the larynx, 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

With mild and moderate adverse reactions:

- stop the drug;

- monitor heart rate and blood pressure;

- if necessary, administer antihistamines 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, a manifestation of the laryngeal edema, requires endotracheal intubation and the administration of large doses of glucocorticosteroids.

Neurological disorders:

Attacks of tetanic convulsions usually cease 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

When extravasal administration of the drug requires non-specific local measures and monitoring of the skin.

Overdose:Currently, there have been no cases of overdose.

Interaction:

- Diuretics.

If diuretics caused dehydration, it increases the risk of developing acute renal failure, especially when using large doses of iobitridol. Before administering yobitridol, the patient should be rehydrated.

- Metformin.

In patients with diabetes mellitus decline in renal function caused by radiographic examination, may be a factor in triggering the development of lactic acidosis (lactic acid acidosis). Metformin should be temporarily discontinued 48 hours before and resumed 2 days after the X-ray examination.

- Beta-blockers.

In the case of development of shock or a decrease in blood pressure with the administration of yobittridol, beta-adrenoblockers are suppressed, 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.

- Interleukin II

Patients who took less than 2 weeks before the study of interleukin II are prone to an increased incidence of delayed adverse reactions: 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.

It is recommended to avoid dehydration before a diagnostic examination and maintain sufficient diuresis in patients with renal insufficiency, diabetes mellitus, myeloma, hyperuricemia, and in patients with senile age with atherosclerosis.

Patients with the greatest risk of developing unwanted reactions may be advisable to conduct premedication.

In patients with pheochromocytoma after the administration of yobitridol, a hypertensive crisis may develop. 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.

The introduction of iodine-containing radiocontrast agents may aggravate the symptoms of myasthenia gravis.

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 that require increased concentration and speed of psychomotor reactions, so use with caution.

Form release / dosage:

Solution for intravenous and intraarterial administration, 300 mg iodine / ml and 350 mg iodine / ml.

Packaging:

50, 100, 200 ml (Xenetics® 300 and Xenetics® 350) into glass bottles (type I or type II Eur.F.), sealed with butyl rubber stoppers and crimped with aluminum caps with plastic lids.

Bottles of 100 and 200 ml are graduated in ml and are either covered with a transparent film with a holder on the bottom of the vial (label of the vial, pasted on top of the film, it is calibrated in ml) or the label has a detachable part used as a holder.

For 1 bottle of 50, 100, 200 ml (Xenetics® 300, Xenetics® 350) is placed in a carton pack together with 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 N010460

Date of registration:29.04.2011

Expiration Date:Unlimited

The owner of the registration certificate:GerbeGerbe France

Manufacturer: & nbsp

GUERBET France

Information update date: & nbsp05.02.2018

Illustrated instructions

Instructions

Xenetics® (Xenetix)