Composition, form of production and packaging
The injection solution is clear, colorless or light yellow.
1 ml
ioxaglate meglumine 393 mg
sodium yogsaglate 196.5 mg,
which corresponds to the content of radioactive iodine 320 mg
Excipients: calcium disodium edetate 0.1 mg, water d / and up to 1 ml.
10 ml - bottles of glass (1) - packs of cardboard.
20 ml - bottles of glass (1) - packs of cardboard.
50 ml - bottles of glass (1) - packs of cardboard.
100 ml - bottles of glass (1) - packs of cardboard.
200 ml - bottles of glass (1) - packs of cardboard.
10 ml - glass bottles (25) - cardboard packs (for hospitals).
20 ml - glass bottles (25) - cardboard packs (for hospitals).
50 ml - glass bottles (25) - cardboard packs (for hospitals).
100 ml - glass bottles (10) - packs cardboard (for hospitals).
200 ml - glass bottles (10) - packs cardboard (for hospitals).
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
Hexabrix 320 is an X-ray contrast agent for blood vessels, urinary tracts, articular cavities, uterine cavity and appendages.
The active substances of the drug are the product of the interaction of the active ingredient of ioxagolic acid and the auxiliary components of meglumine and sodium hydroxide. Ioxaglate is the only ionic low osmolar radiocontrast agent.
Due to its influence on hemostasis, Hexabryx 320 reduces the risk of thrombus formation in catheters and conductors that are used during angioplasty. The results of several clinical studies conducted in the conditions of percutaneous transluminal coronary angioplasty suggest that Hexabryx 320 plays a role in reducing the immediate risk of thrombosis associated with this intervention.
PHARMACOKINETICS
After intravascular injection, the drug is distributed in the circulatory system and interstitial space without marked increase in blood volume or hemodynamic equilibrium.
It is quickly excreted through the kidneys in an unchanged form (not metabolized) by glomerular filtration. Due to low osmolality of solution, osmotic diuresis is very low.
In patients with renal insufficiency, the drug can be excreted through alternative routes - bile ducts, salivary glands, sweat and large intestine.
The components that make up the drug can be removed by dialysis.
INDICATIONS
- intravenous urofa В· sia;
- angiography of any localization, including cerebral and coronary angiography;
- arthrography;
- hysterosalpingography;
- Sialografiya.
DOSING MODE
Indications Adults Children Comments
Average dose Total dose Average dose Total dose
Intravenous urography 1 ml / kg From 50 to 150 ml More than 1 year: 2 ml / kg; Up to 1 year: 2-4 ml / kg Up to 12 kg: 2 ml / kg More than 12 kg: 1.5 ml / kg, min. 24 ml Older than 10 years: lowest dosage level for adults The dose of the drug should be selected depending on the patient's body weight and kidney function. The patient should be able to fasting, but the fluid intake should not be limited.
Angiography <4-5 ml / kg divided by repeated injections Not more than 100 ml per injection> 1 year: 4 ml / kg <1 year: 4-8 ml / kg The injection rate depends on the type of examination performed.
Arthrography 10 В± 2 ml 2 to 4 ml / kg 1 to 2 ml
- knee 8 to 10 ml, double contrast: 3 to 5 ml
- shoulder Up to 10 ml, double contrast: up to 5 ml
- thigh up to 5 ml; up to 20 ml after replacement by the endoprosthesis of the femoral neck
ankle joint Up to 5 ml
- Elbow Up to 5 ml; double contrast: up to 1 ml
- brush and finger 0.5 to 2 ml
Hysterosalpingography 10 to 20 ml, depending on the volume of the uterine cavity Slow introduction through the cervix with a syringe or cannula
Sialografiya 3 ml From 1 lo 6 ml Intra-flow introduction to the excretory ducts of the glands.
SIDE EFFECT
Like all iodine-containing contrast agents, Hexabryx 320 can cause mild, severe or even lethal reactions. These reactions are always unpredictable, but are more frequent in patients with an allergy or anxiety history, or in patients who had a hypersensitivity reaction during an earlier survey using iodine-containing contrast. The test for sensitivity to iodine does not allow to predict the development of these reactions.
There can develop non-hazardous reactions: a feeling of heat, tidal flow, less often nausea and vomiting. These reactions are transitory and go without consequences.
More serious reactions that often occur quickly but may be delayed include skin symptoms, respiratory tract disorders, neurosensory and gastrointestinal disorders, which can be observed either singly or in combination. In some cases, fever and chills may be associated with these symptoms or occur independently.
Adverse effects associated with specific uses:
- pelvic pain and fainting during hysterosalpingography;
- moderate and passing pain with intra-articular injection and / or intraarticular exudation during arthrography.
CONTRAINDICATIONS
- Subarachnoid or epidural administration, as it can cause seizures and lead to death;
- expressed thyrotoxicosis;
- hypersensitivity to yoxagolic acid or to any of the components of the drug;
- Hysterosalpingography during pregnancy or in the presence of an acute inflammatory process in the abdominal region.
With caution: in patients with severe hepatic insufficiency, chronic heart failure, severe respiratory failure, with a history of allergic reactions (hay fever, food allergy), bronchial asthma, diabetes, myeloma, hyperuricemia, pheochromocytoma, emphysema.
PREGNANCY AND LACTATION
In animal experiments, the teratogenic effect was not detected.
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, conducting an examination during pregnancy seems justified. 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, and such a study is prescribed by the doctor because of her need.
Since there is no data on the passage of the drug into breast milk, breast-feeding should be temporarily stopped for at least 24 hours.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution in patients with severe hepatic impairment.
APPLICATION FOR CHILDREN
Assign in accordance with the dosing regimen
SPECIAL INSTRUCTIONS
Due to the risk associated with the use of the drug, the physician must provide constant medical supervision and maintain a venous access throughout the procedure of the examination. At the ready there should always be equipment for emergency resuscitation.
In patients with renal insufficiency, diabetes mellitus, myeloma, hyperuricemia, children under 7 years of age, and in patients with atherosclerosis, it is important to avoid dehydration before the examination and to maintain sufficient diuresis.
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 requiring increased concentration and speed of psychomotor reactions, taking into account the profile of side effects, so apply with caution.
OVERDOSE
As a result of an overdose, cardiorespiratory insufficiency and renal failure may occur. 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. The function of the kidneys should be observed for a minimum of three days. If necessary, hemodialysis is performed.
DRUG INTERACTION
Significant interactions of Hexabrix 320 with other drugs have not been identified, however, this medication should not be confused with others when administered.
Combinations of drugs that require precaution:
Beta-blockers:
In the case of development of shock or lowering of arterial pressure with the administration of yoxagolic acid, beta-adrenoblockers suppress compensatory reactions from the side of 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 yogic acid. Before administering yoxagolic acid, 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 trigger factor in the development of 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 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 arterial pressure, oliguria and even kidney failure.
TERMS OF RELEASE FROM PHARMACY
On prescription.
TERMS AND CONDITIONS OF STORAGE
Store in a place protected from light and inaccessible to children at a temperature of no higher than 30 В° C. Shelf life - 3 years.
