Iobriks - instructions for use, doses, side effects, contraindications

concentration	ABOUTresilience (mOsm / kg H₂ABOUT) 37 ° C	viscosity
concentration	ABOUTresilience (mOsm / kg H₂ABOUT) 37 ° C	20 ° С	37 ° C
300 mg iodine / ml	610-720	11,8	6,3
350 mg iodine / ml	735-880	20,4	10.4

Description:Transparent, colorless or slightly yellowish liquid.

Pharmacotherapeutic group:X-ray contrast medium

ATX: & nbsp

V.08.A Radiocontrast iodine-containing substances

Pharmacodynamics:

Iobriks® is a preparation of yogexol, it is non-ionic, low molecular weight, not dissociating into ions by radiopaque means (PKC). Time to achieve maximum radiopaque in normal pyelography 30 minutes. With computed tomography (CT), contrast imaging in the thoracic region is possible within 1 hour, in the cervical region - about 2 hours, in basal cisterns - from 3 to 4 hours. Contrasting the joint cavities, uterine cavity, fallopian tubes, peritoneal protrusions, pancreatic and biliary ducts, and also the bladder is achieved immediately after administration.

Pharmacokinetics:

Yogexol binds to plasma proteins and serum albumin to a small extent (<2%), which has no clinical significance.

With intravenous administration yogexol is distributed in the extracellular fluid. Through the blood-brain barrier (BBB) under normal conditions does not penetrate. Experiments on animals have shown that yogexol penetrates through the BBB only if it is damaged.

With intravenous administration, the half-life of the drug in patients with normal renal function is about 2 hours.With intrathecal administration, the elimination half-life is 3-4 hours. The maximum concentration of iohexol is determined in the urine approximately 1 hour after intravenous injection.

Metabolites of yogexol were not detected.

In patients with normal renal function, almost 100% of the intravenously injected drug is excreted by the kidneys by glomerular filtration unchanged for 24 hours.

Indications:

Radiocontrast preparation Iobriks® is intended for use only for diagnostic purposes. It is used in adult patients and children for the following studies:

pyelography, cardioangiography, arteriography, urography, phlebography, digital subtraction angiography and CT contrast; arthrography, hysterosalpingography, sialography and gastrointestinal tract research.

Contraindications:

Hypersensitivity to yogeyxol or other components of the drug, thyrotoxicosis.

Carefully:

When using non-ionic radiocontrast agents, care should be taken:

- if there is a history of allergy, bronchial asthma or other undesirable reactions to iodine-containing radiopaque agents.Premedication with glucocorticosteroids or antihistamines is recommended;

- in the diagnostic study of patients with severe cardiovascular diseases and pulmonary hypertension (due to the risk of developing hemodynamic disorders or arrhythmias);

- in the diagnostic study of patients with acute cerebral pathology, tumors or epilepsy in an anamnesis, in connection with the predisposition of such patients to convulsions. The risk of seizures and neurological reactions is also increased in patients with alcoholism and drug dependence;

- in the diagnostic study of patients with severe combined disorders of the liver and kidneys, since they significantly reduced the clearance of radiopaque means;

- for diagnostic study group of patients with renal dysfunction and diabetes, as well as paraproteinemia (mielomatozom and Waldenstrom's macroglobulinemia);

- in the diagnostic study of patients with hyperthyroidism. In patients with multinodular goitre after the introduction of iodine-containing radiocontrast agents, there is a risk of developing hyperthyroidism.With the introduction of radiopaque means for premature infants, consideration should be given to the possibility of developing transient hyperthyroidism;

- in the diagnostic study of patients with hypovolemia. It is necessary to ensure adequatehydration (not less than 100 ml every hour for 4 hours before the test and 24 hours after);

- in the diagnostic study of patients with multiple myeloma, diabetes mellitus, impaired renal function, newborns, children under one year old and elderly patients. It is necessary to conduct adequate rehydration and control of creatinine concentration before and after the introduction of radiopaque;

- when examining patients with diabetes and receiving metformin, before intravascular injection of iodine-containing radiopaque agents. It is necessary to cancel the drug for at least 48 hours before and after administration;

- in the diagnostic study of patients with pheochromocytoma. It is necessary to use low doses of the drug with constant monitoring of blood pressure. To prevent the prevention of the development of hypertensive crisis should be introduced alpha-blockers;

- in the diagnostic study of patients with multiple sclerosis, sickle-cell anemia, obliterating thromboangiitis (Buerger's disease), acute thrombophlebitis, severe atherosclerosis;

- angiography in patients with homocystinuria, chronic emphysema - there is a risk of thrombosis and embolism.

Pregnancy and lactation:

There is a possibility that yogexol penetrates the placental barrier by simple diffusion.

The drug Ibriks® should not be used during pregnancy, except when the intended benefit to the mother exceeds the potential risk to the fetus and the drug, if necessary, is prescribed by the doctor.

Contrast agents are excreted to breast milk to a small extent. When applying the drug during breastfeeding, stop feeding before injection and do not resume at least 24 hours after.

Hysterosalpingography should not be performed during pregnancy and in the presence of acute pelvic peritonitis.

Dosing and Administration:

The drug Iobriks® is intended for intravascular (intra-arterial, intravenous), intrathecal, intracavitary, oral and rectal administration.

The drug is recommended to enter no earlier than 2 hours after taking the food.

The procedure does not require the use of anesthesia.

Prior to use, the Iobrix® preparation should be inspected visually for the absence of insoluble particles, discoloration, and damage to the integrity of the package. When using Ibriks®, a separate syringe and needle should be used. Unused residue should be disposed of.

It should be borne in mind that the radiopaque remedy is easier to transfer if it is heated to body temperature.

When carrying out all types of angiography, it is necessary to ensure sufficient fluid intake in the patient's body before and after the administration of contrast medium. It is recommended to inject the drug IobriX slowly, with constant monitoring of the patient's condition and signs of anaphylactoid reactions. At occurrence of any deviations from norm it is necessary to stop immediately introduction of a preparation and to render medical aid to the patient.

When the drug is administered, the patient should be in a horizontal position with a raised head.

After the administration of the drug, the patient should be under direct medical control for at least 30 minutes, since most adverse reactions occur precisely during this period.

- The dosage of the drug for any study depends on the type of study, the technique used and the technique of administration of the drug, on the body weight (children), age, hemodynamics and the clinical state of the patient.

- Preparation of the patient and measures to prevent the development of adverse reactions are described in the section "Special instructions",

Intrathecal administration

The dose of Iobrix® in myelography depends on the area under study, the technique used and the technique used. The total dose of iodine should not exceed 3.0 g.

The drug should be administered slowly.

To obtain a good resolution in myelography (cervical), the head of the table is raised by 45 ° and held in this position for at least 2 minutes to accumulate a contrast agent.

After myelography, the patient is moved on a gurney with a head raised to 25 °, or on a chair to transport patients.

When moving the patient from the gurney to the bed, the head of the bed is raised by 30-45 °, the patient should be at rest for at least 6 hours. Later the patient can move, avoiding slopes and sudden movements during the day.

If there is a suspicion of a low threshold of seizures, medical supervision of the patient is necessary within 6 hours after the procedure.Further, the patient is recommended a bed rest for 24 hours without water procedures.

Repeated procedures

If, according to clinical necessity, repeated or sequential studies are required, the drug should be administered at an appropriate time interval to ensure the normal excretion of the drug from the body. Before re-introduction it is necessary to maintain the recommended interval - from 6 to 8 days, the minimum interval for urography is 48 hours.

In patients at risk, repeated radiopaque studies should be performed not earlier than the restoration of kidney function to the baseline level (see section "Special instructions").

Table 1. Recommended dosage regimen for each type of angiography

Indication	Concentration, mg iodine / ml	Scope preparation, ml	Notes
*Intravenous administration*
Urography
Adults	300 or 350	40 ~ 80 ml	In some cases, the administration of more than 80 ml
Children (body weight <7 kg)	300	3 ml / kg
Children (body weight> 7kg)	300	2 ml / kg (max 40 ml)
Phlebography (lower limbs)	300	20-100 (per limb)
Digital subtraction angiography	300 or 330	20 ~ 60 ml / injection
*Gain at CT*
Adults	300	100 ~ 200ml	The total amount of iodine is usually 30 ~ 60 g
Adults	350	100 ~ 150ml	The total amount of iodine is usually 30 ~ 60 g
Children	300	1 ~ 3 ml / kg (up to 40 ml)	In some cases, up to 100 ml
*Intraarterial administration*
Arteriography:
Aortic arch	300	30 ~ 40 ml / injection	The volume of injection depends on the site of injection and the volume of blood flow
Selective cerebral angiography	300	5 ~ 10 ml / injection
Aortography	350	40-60 ml / injection
Angiography of the femoral arteries	300 or 350	30-50 ml / injection
Other types	300	Depends on research method
Cardioangiography
Adults Left ventricle, root of the aorta	350	30 ~ 60 ml / injection	The dose is determined, taking into account the degree of hemodelution, the functioning of the heart valves.
Selective coronography	350	4 ~ 8 ml / injection
Children	300 or 350	Max. 8 ml / kg	The dose depends on age, body weight and disease
Digital subtraction angiography	300	1 ~ 15 ml / injection	Depending on the site of application, volumes up to 30 ml
*Intrathecal administration*
To minimize adverse reactions, the total dosage of iodine should not exceed 3.0 g
Cervical myelography (lumbar injection)	300	7 ~ 10 ml
Cervical myelography (lateral cervical injection)	300	6 ~ 8 ml	the drug should be administered slowly
*Intracavernal administration*
Arthrography	300	5 ~ 15 ml
Arthrography	350	5 ~ 10 ml
Hysterosalpingography	300	15 ~ 25 ml
Sialografiya	300	0.5 ~ 2 ml
*Gastrointestinal*
Adults Oral:	350	individually
Children (esophagus)	300 or 350	2 ~ 4 ml / kg	The maximum volume of administration of the drug is 50 ml
Premature babies	350	2 ~ 4 ml / kg
Children Rectal:	Dilute drinking water to 100-150 mg iodine / ml	5 ~ 10 ml / kg	Example: dilute IobriX® 300 mg iodine / ml or 350 mg iodine / ml with water 1: 1 or 1: 2
*CT scan*
Adults Oral:	Dilute with water to a concentration of about 6 mg iodine / ml	800 ~ 2000 ml of diluted solution	Example: dilute IobriX® 300 mg iodine / ml shea 350 mg / ml with water 1:50
Children Oral:		15 ~ 20 ml / kg (dilute solution)
Children Rectal:	Dilute with water to a concentration of 6 mg iodine / ml	is selected individually

Additional instructions for working with autoinjector / pump

Bottles of a 500 ml contrast medium should only be used together with an autoinjector and pumps approved for this volume. The procedure should be performed with a single puncture of the vial plug.

The system from the autoinjector / pump to the patient should be replaced after each of the patients.

When using the autoinjector / pump, follow the manufacturer's instructions.

Precautionary measures:

Do not use the drug in the presence of any foreign particles, discoloration or compromise of the integrity of the package.
When using the drug Iobriks®, you should strictly follow the rules of aseptic, since the drug does not contain preservatives. The drug should be taken in a separate syringe in aseptic conditions, before direct application.
Do not mix the drug with other drugs, you need to use a separate syringe and needle.
When performing vascular catheterization, attention should be paid to the technique of angiography and often to flush the catheter (for example, 0.9% solution of sodium chloride with the addition of heparin) to minimize the risks of thrombosis and embolism.
Before and after the administration of the contrast agent, it is necessary to conduct sufficient rehydration of the patient. The procedure of rehydration is especially necessary in elderly patients, patients with multiple myeloma, diabetes mellitus, and renal dysfunction. Newborn infants and infants (up to 1 year old), as well as younger children, are particularly sensitive to electrolyte imbalances and changes in hemodynamics (see section "Special instructions").
In patients who have a history of allergy, bronchial asthma, premedication with glucocorticosteroids or H blockers is recommended to prevent the risk of developing hypersensitivity reactions₁ and H₂-gistaminovyh receptors for 1 hour before the examination of iodine-containing contrast agents (see section "Special instructions").
In patients with acute cerebral pathology or epilepsy in history, predisposing to seizures, it is recommended that premedication with barbiturates or phenytoin.
Unused remnants of the drug that remain in the vial and the connecting tubes must be disposed of at the end of the day. If necessary, it is advisable to use bottles of a smaller volume.

Side effects:

The incidence of side effects is based on data that was recorded during clinical trials, spontaneous reports described in the internal clinical documentation, published studies and included data on more than 9,000 patients, as well as clinical studies in the post-marketing period.

Classification of the incidence of side effects is defined as follows: very often (≥1 / 10),often (≥ 1/100 to <1/10), infrequently (≥ 1/1000 - <1/100), rarely (≥ 1/10000 - <1/1000), very rarely (<1/10000), with unknown frequency (which can not be estimated from the available data).

Common adverse reactions:

characteristic for all iodine containing contrast agents, as a rule, are always moderate and short-lived. Serious adverse reactions, as well as cases with a fatal outcome, are very rare. Yogexol - a drug with low osmolality and to a lesser degree causes dilation of veins, endothelial injuries, pain and complications.

From the immune system:

Rarely: hypersensitivity reactions (can occur regardless of dose and route of administration), which are usually manifested as moderate breathing disorders (dyspnea, bronchospasm, laryngospasm, laryngeal edema) or skin reactions such as rash, itching, erythema, urticaria; iodism or "iodine pig" - a reaction to the introduction of iodine-containing contrast agents, expressed in the increase and soreness of the salivary glands, up to 10 days after the test.

With unknown frequency: anaphylactic shock, angioedema, reactions may occur in the form of Stevens-Johnson syndrome or toxic epidermal necrosis.

Allergic reactions can develop immediately after the injection or a few days later.

From the nervous system:

Rarely: headache;

Rarely: dysgeusia (a transitory "metallic taste"), there may be an increase in temperature with the development of convulsive syndrome;

With unknown frequency: fainting.

From the cardiovascular system:

Rarely: arrhythmia, hemodynamic disorders, asthenia (including dysphoria, fatigue);

Rarely: arterial hypertension, vasovagal reactions may occur in the form of arterial hypotension and bradycardia, aggravation of myasthenia gravis;

Infrequently: there were "tides" of blood to the face.

Gastrointestinal disorders:

Rarely: a feeling of discomfort or pain in the abdomen, dry mouth, gastrointestinal reactions in the form of nausea, vomiting and diarrhea.

Mestno:

Often: in place of the introduction of a feeling of heat, pain;

Rarely: itching, redness.

Laboratory indicators:

All iodine-containing contrast agents distort the results of thyroid radioisotope studies (the iodine-binding capacity of the thyroid gland can be reduced for up to several weeks).

Often there is an increase in the activity of amylase in the blood serum.

On the day after the test, laboratory tests should not be carried out, since high concentrations of contrast medium in serum and urine can influence the laboratory indices of bilirubin, proteins or inorganic substances (iron, copper, calcium and phosphates). There is a temporary increase S-creatinine.

Adverse reactions associated with intravascular (intra-arterial and intravenous) administration:

Depending on the place of administration and dose, a different picture of adverse reactions to the use of intra-arterial administration of radiocontrast agents is observed. Very rarely, when injected into the coronary, cerebral or renal arteries, an arterial spasm can develop, leading to transient ischemia in the organ under examination.

In selective angiography and other studies, when the contrast preparation enters the target organ in a high concentration, abnormalities in the functions of the organ being examined can be observed.

With peripheral angiography - often there is soreness or a feeling of warmth.A transient increase in creatinine levels can often be observed in the blood serum, but it does not have clinical significance.

Rarely: perforation of the vessel; in patients from the high-risk group, severe manifestations with a fatal outcome are described;

Rarely: reduced platelets, hepatic dysfunction.

From the nervous system:

Rarely: In the form of convulsions, transient disorders of sensitivity or motor function, neurologic reactions may occur. In isolated cases, the contrast agent can penetrate the blood-brain barrier, resulting in accumulation of the drug in the cerebral cortex at CT. This phenomenon can persist throughout the day after the study, sometimes accompanied by a transient disruption of orientation in space or cortical blindness. There were tremors, drowsiness, nystagmus.

From the side of the cardiovascular system:

Rarely: arrhythmia (including bradycardia, tachycardia);

Rarely: hyperemia, severe reactions are observed in the form of rhythm disturbances, a decrease in myocardial contractility, coronary artery spasm, myocardial ischemia, respiratory arrest, cardiac arrest;

With unknown frequency: the development of thrombosis and post-venereal thrombophlebitis was observed.

From the respiratory system:

Rarely: can develop acute respiratory symptoms and signs (including dyspnea, bronchospasm, laryngospasm, noncardiogenic pulmonary edema), cough.

From the endocrine system:

With unknown frequency: possibly the development of thyrotoxicosis. Patients at risk for thyrotoxicosis should be carefully examined before using iodinated contrast medium; exacerbation of pancreatitis.

From the side of the urinary system:

Rarely: the introduction of a large dose of the drug in the renal artery can cause a decrease in kidney function, anuria, temporary proteinuria, hematuria, oliguria, the development of renal failure.

From the side of the musculoskeletal system:

With unknown frequency: single cases of arthralgia are described.

Locally:

Often: At the site of injection, fever, swelling, local soreness and radicular pain can be felt;

With unknown frequency: extravasation of the drug.

Adverse reactions associated with intrathecal injection:

Associated with intrathecal administration of radiocontrast agents, adverse reactions may be delayed and occur within a few hours or days after the examination. The frequency of occurrence of similar reactions is comparable with the frequency of complications after lumbar punctures without the introduction of a contrast agent.

From the nervous side systems:

Often: there is headache, nausea and dizziness; the reason for the appearance of such effects is in the reduction of pressure in the subarachnoid space due to leakage of the CSF through the puncture site. Some patients may experience severe headache, back pain, neck pain for several days.

Often: paresthesia and radicular pain at the puncture site, cramps and pain in the legs;

Rarely: in some cases signs of irritation of the dura mater can be manifested in the form of photophobia and meningism;

Rarely: aseptic meningitis for the administration of a contrast agent (including chemical meningitis);

With unknown frequency: transient dysfunction of the central nervous system, manifested in violations of orientation, aphasia, sensitivity disorders, impaired motor function and convulsions, confusion, dysarthria.Some of these patients may experience changes in the electroencephalogram (EEG).

From the sense organs:

With unknown frequency: cases of temporary hearing loss or deafness after myelography were noted, which may be due to a decrease in pressure of cerebrospinal fluid due to lumbar puncture; short-term loss of vision.

From the gastrointestinal tract:

Often: vomiting;

Rarely: diarrhea.

Adverse reactions with intracavitary injection:

General hypersensitivity reactions develop extremely rarely. The extravascular administration of contrast agents in rare cases can cause local pain and swelling, which usually pass without consequences. In the case of development of compression symptoms, surgical decompression is recommended.

Arthrography: often a feeling of pressure and pain may occur at the injection site.

From the side of the musculoskeletal system:

Rarely have there been cases of developing arthritis to administer the drug. There is a risk of developing infectious arthritis.

Hysterosalpingography (GHA): often - a moderate, transient pain in the lower abdomen.

Gerniography: often - locally: moderate pain after the study.

Inflammation and necrosis of tissues can rarely occur, cold and elevated limb position are recommended for medical activities. In the case of development of compression symptoms, surgical decompression is recommended.

Oral admission: often - there are disorders of the gastrointestinal tract (nausea, diarrhea); infrequently - pain in the abdomen.

Overdose:

Overdose is unlikely in patients with normal renal function, until the patient receives more than 2000 mg iodine / kg over a limited period of time. There is no specific antidote.

Treatment symptomatic, it is possible to conduct hemodialysis. In the case of using high doses of the drug, the duration of the study (half-life of the drug about 2 hours) has a large effect on the kidneys. In case of an overdose, correction of the water-electrolyte imbalance is necessary. Control of kidney function should be carried out for the next 3 days.

Interaction:

When used simultaneously with antipsychotic drugs, analgesics and antidepressants, it is possible to reduce the convulsive threshold and increase the risk of developing adverse reactions.You should stop taking these medications 48 hours before the test and resume no earlier than one day after the administration of the contrast agent.

Premedication with glucocorticosteroids or blockers H₁ and H₂-histamine receptors for 1 hour prior to examination by iodine-containing contrast agents, prevents risks of development of hypersensitivity reactions, including "delayed", in patients with a history of allergy, bronchial asthma.

When using yogexol in a study of patients with diabetic nephropathy taking biguanides (metformin), there is a risk of transient renal dysfunction and development of lactic acidosis. It is necessary to stop taking biguanides 48 hours before the start of the examination and resume the reception after the kidney function is completely stabilized.

When yogexol is used in patients taking beta-blockers, manifestations of anaphylaxis can be atypical and mistaken for vagal reactions.

With the use of yogexol in patients who took less than 2 weeks before interleukin-2, an increased incidence of delayed adverse reactions (flu-likeconditions or skin reactions).

Yogexol enhances the effect of nephrotoxic drugs.

Special instructions:

All types of angiography can be performed only by a specialist in the presence of an intensive care unit.

It is recommended to always install a cannula or catheter to ensure rapid intravenous access throughout the radiographic procedure.

Use a separate autoinjector / syringe and needle to inject Iobrix® and not mix it with other medications.

Preparation of the patient and the procedure for administering the drug:

Before applying the contrast agent, it is necessary to obtain accurate information about the patient, including laboratory data (including serum creatinine concentration, electrocardiogram, history of allergy, pregnancy). Before and after the administration of the contrast agent, it is necessary to conduct sufficient rehydration of the patient.

If the patient has previously experienced allergic reactions or asthmatic attacks on iodine-containing contrast media, it is recommended that glucocorticoids be premedicated (prednisolone, dexamethasone and others) and antihistamine drugs for 1 hour before the study.

It is not recommended to perform a preliminary bolus injection of the drug to detect individual sensitivity to the drug, due to the risk of possible severe hypersensitivity reactions.

Patients who are afraid of waiting before the procedure of study, it is recommended premedication with sedatives.

Use in high-risk groups:

Care should be taken in all types of angiography in groups at increased risk of adverse reactions, These include:

- elderly patients, newborns, children under one year, patients with cardiovascular diseases and small-scale hypertension, thyroid diseases, patients with bronchial asthma and other allergies, weakened patients, as well as patients with paraproteinaemia (myelomatosis and Waldenstrom macroglobulinemia ). It is necessary to eliminate the disturbances of the water-electrolyte balance before ensuring that the fluid reaches the body (see the section "Contraindications").

In patients who have a history of allergy, bronchial asthma, premedication with glucocorticosteroids or H blockers is recommended to prevent the risk of developing hypersensitivity reactions₁ and H₂-gistaminovyh receptors for 1 hour before the examination of iodine-containing contrast agents.
In patients with acute cerebral pathology or epilepsy in history, predisposing to seizures, it is recommended that premedication with barbiturates or phenytoin.
In patients with impaired renal function, it is recommended to take measures to prevent acute renal failure after the introduction of radiopaque. Patients on hemodialysis can be given radiopaque agents provided dialysis is performed immediately after the examination.
In patients with impaired renal and hepatic function, there may be a significant delay in the clearance of the contrast agent (see the section "Contraindications").
Alcohol and drug dependence patients also have increased risk of seizures and neurological reactions; When developing seizures, diazepam or barbiturates are recommended.
In patients with diabetes mellitus receiving metformin therapy, in order to prevent the development of lactic acidosis, it is necessary to monitor the concentration of creatinine before the intravascular injection of the contrast agent. Metformin should be discontinued 48 hours before the contrast agent is administered and resumed no earlier than 48 hours after the administration, with normal kidney function and creatinine concentration in the serum. If the kidney function is abnormal or not known, the physician should assess the benefit / risk ratio from contrast agent research and take precautions. It is necessary to stop taking metformin 48 hours before the test, rehydrate and monitor the clinical condition of the patient and the appearance of the initial symptoms of lactic acidosis.

Measures for the prevention of adverse reactions:

- Identification of patients at high risk.

- Ensure adequate rehydration of the patient, if necessary by continuous intravenous infusion, started before the administration of the contrast agent and continuing until it is excreted by the kidneys.

- Prevention of an additional burden on the kidneys arising from the use of nephrotoxic drugs for oral administration during cholecystography, renal artery compression, renal artery angioplasty, or extensive surgical operations, until the contrast agent is removed from the body. The introduction of a large dose of the drug in the renal artery can cause hematuria, proteinuria, an increase in the concentration of creatinine and urea nitrogen, which can lead to kidney damage.

- Patients with pheochromocytoma in the study of radiopaque and means for the prevention of hypertensive crisis should be prescribed alpha-adrenoblockers and control blood pressure.

- Repeated radiocontrast studies should be performed not earlier than restoration of kidney function to the baseline level.

- There is a potential risk of transient liver dysfunction. In patients with impaired renal and hepatic function, the clearance of the radiopaque preparation can be significantly reduced.

Intrathecal administration:

After myelography, the patient is moved on a gurney with a head raised to 25 °, or on a chair to transport patients.When moving the patient from the wheelchair to the bed, the head of the bed is raised by 30-45 °; After the procedure, the patient should be at rest for at least the first 3 hours. Later the patient can move, avoiding slopes and sudden movements.

If there is a suspicion of a low threshold of seizures, medical supervision of the patient is necessary within 6 hours after the procedure. Further, the patient is recommended a bed rest for 24 hours without water procedures.

All iodine-containing contrast agents may affect functional thyroid gland tests, since the iodo-binding ability of thyroid tissue can be reduced within a few weeks. High concentrations in serum and urine can influence the determination of biochemical parameters: bilirubin, protein and organic substances (for example, iron, copper, calcium and phosphates). Therefore, it is not recommended to perform tests on these indicators on the day of the study (mm section "Side effect").
Vials are for single use only, unused residues of Ibriks® should be disposed of.
Do not freeze the drug.

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

It is not recommended after the procedure of the study to drive a car or other mechanical means for the next 24 hours due to the possible occurrence of delayed adverse reactions.

Form release / dosage:Solution for injection, 300 mg iodine / ml and 350 mg iodine / ml.

Packaging:

For 50, 100, 150 or 500 ml of the preparation in a colorless glass bottle (Hept.F. type I or II), sealed with a rubber stopper and crimped with a Teflon-coated cap, topped with a plastic cap made of polypropylene.

On bottles with a volume of 50, 100, 150 and 500 ml there is a label, it is also possible to use a label, the lower part of which is used as a hinge for hanging the bottle when used. A 500 ml bottle can be equipped with a plastic basket made of polypropylene yarn, with a hinge for hanging.

For 10 bottles of 100 ml, 150 ml or 500 ml, 25 bottles of 50 ml each are placed in a secondary packaging - a cardboard tray, together with the instruction for use and sealed with a film of PVD on top.

Storage conditions:

In a dry place, protected from secondary X-rays, at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:PL-003069

Date of registration:01.07.2015

Expiration Date:01.07.2020

Manufacturer: & nbsp

TAEJOON PHARM, Co., Ltd. The Republic of Korea

Information update date: & nbsp27.11.2017

Illustrated instructions

Instructions

Ibriks® (IOBRIX®)