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

Active substanceJoversolJoversol

Similar drugsTo uncover

solution in / in

Dosage form: & nbspsolution for intravenous and intraarterial administration

Composition:

1 ml of the solution contains:

Active substance:
Joversol,	509 mg	636 mg	678 mg	741 mg
which corresponds
iodine concentration	240 mg	300 mg	320 mg	350 mg

Excipients: trometamol hydrochloride 4.1 mg, trometamol 0.48 mg, sodium calcium edetate 0.2 mg, water for injection up to 1 ml.

Description:Transparent, colorless or yellowish liquid.

Pharmacotherapeutic group:radiopaque

ATX: & nbsp

V.08.A Radiocontrast iodine-containing substances

Pharmacodynamics:

Physicochemical characteristics:

Concentration	Osmolality (mOsmol / kg)	Viscosity (mPasek)
240 mg iodine / ml	from 465 to 575	from 4,0 to 5,3
300 mg iodine / ml	from 580 to 705	from 7.0 to 8.6
320 mg iodine / ml	from 615 to 745	from 8.6 to 10.5
350 mg iodine / ml	from 670 to 810	from 12.0 to 14.6

Pharmacodynamics

Optiery is a nonionic radiopaque substance. With intravascular administration of the drug, the blood stream containing the contrast agent becomes opaque to X-rays.

This ensures radiographic visualization of the circulatory system, organs, until the concentration of contrast medium is reduced to a certain level with blood mixing.

Pharmacokinetics:

With intravenous administration, Optiuric, which has hydrophilic properties and a low ability to bind to plasma proteins (less than 2%), is rapidly distributed into the extracellular fluid and is rapidly excreted through the kidneys through glomerular filtration. Mean values of the half-life of the drug after doses of 50 and 150 ml were 113 ± 8.4 and 104 ± 15 min, respectively. More than 95% of the administered dose of the drug was allocated during the first 24 hours. The maximum concentration of the contrast agent in the urine is detected approximately one hour after the infusion. Excretion of the drug with feces is negligible. Optiery is practically not metabolized and does not undergo deiodination. The drug does not penetrate the blood-brain barrier, and through the placenta to a small extent.

Indications:

Optirayy apply in adults as radiopaque means for the following X-ray studies:

- angiography of the brain,

- angiography of peripheral vessels;

- angiography of the vessels of the abdominal cavity, including in the digital subtracting intra-arterial and intravenous angiography (VA-CVA and BB-CVA);

- venography;

- intravenous urography;

- computed tomography (CT) scan of the patient's head and body.

Optiery 300 mg of iodine / ml can be used in children with angiography of the brain, peripheral vessels and vessels of the abdominal cavity, as well as for intravenous urography.

The efficacy and safety of the drug Optiray 240 and 350 mg iodine / ml when applied to their pediatric practice has not been proven.

Contraindications:

Contraindicated intrathecal administration of the drug, as well as the use of the drug in the presence of an anamnesis:

- hypersensitivity to iodine-containing drugs, including iodine-containing radiopaque agents,

- expressed thyrotoxicosis,

- decompensated renal and / or hepatic insufficiency;

- serious violations of the cardiovascular system;

- epilepsy;

- multiple myeloma.

In acute inflammatory diseases of the pelvic organs, hysterosalpingography is contraindicated.

In acute pancreatitis, endoscopic retrograde cholangiopancreatography is contraindicated.

Carefully:

Special care should be taken when prescribing the drug to patients with diseases:

- renal and / or liver failure;

- of cardio-vascular system;

- emphysema of the lungs;

- pronounced atherosclerosis of cerebral vessels;

- decompensated diabetes mellitus;

- latent hyperthyroidism;

- nodular goiter of mild and moderate severity;

- patients with sickle-cell anemia;

- pheochromocytoma.

The drug should be administered with extreme caution on the background of the patient's general severe condition.

Pregnancy and lactation:

Studies on the safety of the use of the drug Optireus in pregnant women have not been conducted. In studies on animals, there was no teratogenic and / or mutagenic effect of the drug.

At pregnancy the preparation appoint or nominate only in those cases if the attending physician considers it absolutely necessary in view of possible risk for a fetus.

During pregnancy, hysterosalpingography is prohibited. Excretion of the drug with breast milk is insignificant and, according to the available experience, the likelihood of harm to the child is low, however, if it is necessary to prescribe the drug of the mother during lactation, it is necessary to interrupt breast-feeding for 24 hours.

Dosing and Administration:

The drug is administered intravenously or intra-arterially, struino or drip.

General information

The drug is typed in a syringe or a bottle for drip introduction immediately before the procedure. The bottle with a contrast agent is intended exclusively for single use, the rubber stopper of the bottle is pierced only once, the rest of the contrast agent is destroyed.

The contrast agent is always heated to the body temperature before administration.

Premises in which procedures are performed using radiocontrast preparations should be provided with equipment and medicines that are needed in emergency situations (oxygen cylinders, antihistamines and vasoconstrictors, glucocorticosteroid preparations).

A warning

It is forbidden to mix radiopaque with other medications.

Preparation of patient

Before applying the contrast agent, you need to obtain accurate information about the patient, including important laboratory data (eg, serum creatinine level, ECG, history of allergy, pregnancy).

Before the study, the patient should eliminate the disturbance of the water electrolyte balance and ensure a sufficient supply of fluid and electrolytes.This is especially true for patients with diabetes, polyuria, oliguria or gout, as well as infants, and young children, elderly patients.

Two hours before the procedure, the patient should stop eating.

It is not recommended to perform preliminary testing of individual sensitivity with the use of small doses of the drug, due to the risk of severe hypersensitivity reactions.

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

Within 30 minutes after the end of the procedure, the patient is monitored physically, since most reactions occur precisely during this period.

To provide immediate assistance in case of acute adverse reactions, you should ensure constant access to the vessel (constant cannula). The funds required in these cases must be available.

Patients experiencing fear of waiting, need premedication calming means.

Recommended doses

The dosage of the drug depends on the age, weight, condition of hemodynamics and the general condition of the patient, as well as the area of the vessels that are examined.The administered dose is also affected by the technology of examination and the selected concentration of iodine in the preparation.

OPTIRIES 240, 300, 320

Adults

Type of examination	Dosage
Angiography of the brain:
Sleep or vertebral artery	2-12 ml
Angiography of four vessels	20-50 ml
If necessary, repeated administration of a single dose is possible.
Angiography of peripheral vessels:
Fork of the aorta	20-90 ml
Common iliac or femoral artery	10-50 ml
Subclavian / brachial artery	15-30 ml
If necessary, repeated administration of a single dose is possible.
Angiography of the vessels of the abdominal cavity:
The celiac artery	12-60 ml
Upper mesenteric artery	15-60 ml
Lower mesenteric artery	6-15 ml
Angiography of the kidneys	6-15 ml
If necessary, repeated administration of a single dose is possible.
VA-CVA	5-40 ml
VV-CVA	30-50 ml
If necessary, repeated administration of a single dose is possible.
Venography	30-80 ml
Intravenous urography	65-80 ml

If you are in doubt about getting a good contrast, for example, when examining elderly patients or patients with renal insufficiency it is allowed to increase the dose of contrast medium to 1.6 ml per kg of body weight.

Computer tomography of the head	65-150 ml
Computed tomography of the trunk	65-150 ml

Elderly patients: the dosage is the same as for adults.

Children:

	Recommended dosage:
Angiography of the brain	1-3 ml / kg body weight
Angiography of peripheral vessels	1-3 ml / kg body weight
Angiography of the vessels of the abdominal cavity	1-3 ml / kg body weight
Intravenous urography	2 ml / kg (over 1 year)
	3 ml / kg (less than 1 year)

The safety and effectiveness of the drug for other studies in children is not established.

OPTIRY 350

Type of examination	Recommended dosage
Angiography of peripheral vessels:
Fork of the aorta	60-90 ml
Common iliac or femoral artery	10-50 ml
Subclavian / brachial artery	15-30 ml
Angiography of the vessels of the abdominal cavity:
The celiac artery	12-60 ml
Upper mesenteric artery	15-60 ml
Lower mesenteric artery	6-15 ml
Angiography of the kidneys	6-15 ml
Aortography	10-80 ml
Coronary arteriography	4-10 ml
Left ventriculography	30-50 ml
VA-CVA	5-80 ml
VV-CVA	30-50 ml
Venography	50-100 ml
Internal urography	50-75 ml
Computer tomography of the head	50-150 ml
Computed tomography of the trunk	25-150 ml

Side effects:

According to the drug test, adverse reactions from mild to moderately severe are observed in 1.1% of patients. Very rarely (<1 / 10,000) serious adverse, life-threatening reactions develop.

Typically, most adverse reactions develop in the first few minutes after the administration of contrast medium. There are reports of the appearance of delayed reactions of intolerance a few days after receiving the drug.

Patients often note feelings of discomfort, heat or cold (10-50%). These feelings depend on the dose, the concentration of the drug and the area of the body where the injection was performed. Often there are also painful sensations.

Most of the negative side reactions to Optiery refer to pseudoallergic reactions of intolerance, which can develop after using any iodine-containing radiopaque substance.

During the use of the drug, the symptoms of adverse reactions listed below were recorded in at least 0.1% of patients: nausea (0.4%), urticaria, followed by skin rashes (0.3%) and vomiting (0.1%). All other symptoms occurred in less than 0.1% of patients.

Hypersensitivity reactions can occur which usually manifest as mild breathing disorders (dyspnea, bronchospasm) or skin reactions such as rash, erythema, urticaria, pruritus, and in some cases develops Quincke's edema. Allergic manifestations can occur either immediately after the administration of the drug, or several days later. There are reports of toxic skin reactions. Pronounced hypersensitivity reactions, such as laryngeal edema, pulmonary edema, are rare.

In very rare cases, serious and fatal anaphylactic reactions were noted, affecting mainly the cardiovascular and respiratory system. Severe hypersensitivity reactions were noted in patients with a predisposition to allergies, as well as in those taking beta-adrenoblockers.

Anaphylactoid reactions can occur regardless of the dose and mode of administration; A serious side effect may begin with minor hypersensitivity reactions. In this case, it is necessary to stop the drug immediately and start, if necessary, emergency therapy using intravascular drug administration.

Perhaps the emergence of serious reactions from the cardiovascular system, such as peripheral vasodilation, severe arterial hypotension, tachycardia, dyspnea, agitation, cyanosis and loss of consciousness that may require urgent treatment.

Quite often there was a transient bradycardia. When using the drug for cardiac examinations, angina, cardiac arrhythmia and ECG changes were observed.

In patients undergoing angiocardiographic procedures, special attention should be given to the state of the right heart and pulmonary circulation. The introduction of an organic iodine-containing solution in the absence of right heart and pulmonary hypertension can cause bradycardia and arterial hypotension.

In this regard, increased caution should be observed when introducing a contrast agent in the right heart cavity of newborns with pulmonary hypertension and impaired cardiac function.

In some cases, mainly after the administration of the drug in the arteries of the brain, there were temporary neurological reactions (fainting, visual impairment, confusion, convulsions, hemiparesis).

Patients suffering from severe renal failure, combined liver and kidney disease, anuria, diabetes mellitus, sickle cell anemia or monoclonal gammapathy (multiple myeloma, macroglobulinemia), especially when administering large doses of the substance, can have serious impairment of kidney function, and even acute renal failure, so before using the drug Optiery, you must enter a large amount of fluid into the body, this will reduce the likelihood of usheniya renal function.

There is information about the local reaction in the zone of drug administration, expressed in spasms of the vessels or tissue damage, especially after the appearance of extravasate.

Overdose:

Overdosing can occur only if there is a marked impairment of kidney function or accidental administration of large doses of the drug.

Excessive doses of Optiuras, as well as all iodine-containing radiocontrast substances, can cause serious complications, especially from the cardiovascular, respiratory system and kidney function.

Treatment these conditions are carried out in accordance with the symptoms.To remove the drug Optiray from the blood can use hemodialysis. There is no specific antidote to the drug.

Interaction:

The simultaneous use of antipsychotics, analgesics and antidepressants can reduce the convulsive threshold, increasing the risk of adverse reactions associated with the use of contrast media.

In patients with diabetic nephropathy who take biguanides, with the introduction of a contrast agent, the development of a transient disturbance of kidney function and lactic acidosis is possible. To prevent this complication, you should stop taking biguanides 48 hours before the procedure. To resume the administration of biguanides, you should ensure that there is no impairment of kidney function.

Hypersensitivity reactions may be more pronounced in patients taking beta-blockers.

In patients taking interleukin, more often there are delayed reactions: fever, rashes, itching, joint pains and symptoms resembling the flu.

In some patients with impaired liver function who received oral preparations for a cholecystographic examination prior to the administration of contrast agents for the study of blood vessels, nephrotoxicity was documented.

When the radiocontrast substance is injected into the artery after the use of vasoconstrictive drugs, the probability of neurological adverse reactions of the body increases significantly.

It should be borne in mind that the results of tests on protein-related iodine and studies of the absorption of radioactive iodine will not correctly reflect the function of the thyroid gland within 16 days after the administration of the iodine-containing radiopaque preparation.

Special instructions:

Diagnostic procedures using iodine-containing contrast agents of intravascular application should be conducted under the supervision of personnel who have been trained and who have experience in performing this survey.

Allergy sufferers require special attention. To prevent or mitigate allergic reactions when administering the drug should consider the advisability of pre-introduction of antihistamines and corticosteroids. However, such premedication does not always prevent the occurrence of serious adverse reactions. The patient should be warned that allergic reactions can develop not immediately, and a few days after the administration of the drug,and that in this case it is necessary to immediately consult a doctor.

Observation of patients suffering from congestive heart failure should continue for several hours after the examination procedure, which will allow detecting delayed hemodynamic disorders that may be associated with a temporary increase in the osmotic load on the cardiovascular system.

In connection with the danger of the emergence of hypertensive crisis in patients suffering from pheochromocytoma, it is recommended to premedicate with alpha-blockers before the introduction of contrast medium.

Given the likelihood of hypothyroidism in newborns, especially in premature newborns, due to the excessive amount of iodine in the body when administering the drug, it is recommended to perform a control analysis of the level of TSH and T4 in 7-10 days and 1 month after the administration of iodine-containing contrast medium.

When examining some patients with a contrast agent, general anesthesia can be indicated. In these cases, it should be borne in mind that adverse reactions in patients may be related to the hypotonic action of the anesthetic.

When angiographic examination should not be overlooked the probability of vascular damage during manipulations with the catheter and with the introduction of contrast media.

In order to avoid thromboembolism, it is necessary to carefully work out the technique of examination, especially with arteriography. The use of special guides for the catheter, a three-way stopcock, frequent rinsing of the catheter with saline solution supplemented with heparin and timely completion of the survey will reduce the risk of thromboembolism.

If possible, angiographic examination should not be prescribed for patients suffering from homocystinuria due to an increased risk of thrombosis and embolism.

Particular attention should be given to the procedure for examining patients suffering from progressive atherosclerosis, severe hypertension, heart failure, the elderly, patients who had thrombosis or embolism of cerebral vessels or migraine. These patients have increased the risk of developing cardiovascular reactions, such as bradycardia, raising or lowering blood pressure.

When conducting venography in patients with suspected phlebitis, local inflammation, severe ischemic disease or complete blockage of the venous system, special care should be taken.

To avoid the occurrence of extravasate when the drug is administered, it is recommended to monitor the process with fluoroscopy.

When angiography of peripheral vessels, it is necessary to make sure that there is pulsation in the artery into which the radiopaque preparation is injected. Carrying out of angiography in patients suffering from obliterating thromboangiitis or ascending infection in combination with severe ischemia, special care should be taken.

Effect on the ability to drive transp. cf. and fur:In the literature there is no information on the possible effect of the drug on persons driving a car or other machines. However, in connection with the likelihood of occurrence of adverse reactions, drivers of cars and other technical means are not recommended to sit behind the wheel within an hour after the administration of the drug.

Form release / dosage:

Solution for intravenous and intra-arterial administration, 240 mg iodine / ml, 300 mg iodine / ml, 320 mg iodine / ml, 350 mg iodine / ml.

Packaging:

10 ml, 20 ml, 50 ml, 75 ml, 100 ml, 150 ml, 200 ml and 500 ml in the bottles of colorless glass of class I hydrolytic resistance according to EP 97, sealed with plugs of bezlatex bromobutyl rubber 20 and 32 mm in diameter and crimped with aluminum caps .

It is allowed to use aluminum caps with snapping plastic caps with color indication for the dosage of the drug: 240 mg iodine / ml - red indication, 300 mg iodine / ml - green indication, 320 mg iodine / ml - purple indication, 350 mg iodine / ml - .

10 bottles of 10 ml, 20 ml, 50 ml, 75 ml, 100 ml, 150 ml, 200 ml and 5 bottles of 500 ml along with the instructions for use are placed in a cardboard box.

To 30 ml, 50 ml into syringes for manual injection from polypropylene. 1 put the syringe in the blister. 10 blisters with instructions for use are placed in a cardboard box.

For 50 ml, 100 ml and 125 ml in syringes for the automatic injector with adapter "Luer Lock".

1 syringe with adapter "Luer Lock" is placed in the blister. 10 blisters together with instructions for use are placed in a cardboard box.

Storage conditions:

In the dark place at a temperature of no higher than 30 ° C. Storage is allowed for 1 month at a temperature of 37 ° C in a heater for contrast agents with air circulation.

Do not expose to x-rays.

Do not freeze.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:П N014828 / 01

Date of registration:01.07.2008

The owner of the registration certificate:Mallinkrodt Inc.Mallinkrodt Inc. USA

Manufacturer: & nbsp

MALLINCKRODT, Inc. USA

ORTAT, CJSC Russia

Information update date: & nbsp08.11.2015

Illustrated instructions

Instructions

Optiray (Optiray)