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

Excipients: trometamol 1.21 mg, sodium calcium edetate 0.10 mg, hydrochloric acid 5 M solution to pH 6.8-7.6 how much, water for injection up to 1.00 ml.

Description:

Transparent, colorless or slightly yellowish solution.

Pharmacotherapeutic group:radiopaque

ATX: & nbsp

V.08.A Radiocontrast iodine-containing substances

Pharmacodynamics:Physicochemical characteristics:

Yogexol is a nonionic, monomeric, triiodinated, water-soluble radiocontrast agent. The pH of the preparation is 6.8-7.6.

Omnipac® osmolality and viscosity are listed below:

Concentration	Osmolality * (Osm / kg H₂O) 37 ° C	Viscosity (mPa * s)
Concentration	Osmolality * (Osm / kg H₂O) 37 ° C	20 ° С	37 ° C
240 mg iodine / ml	0,51	5,6	3,3
300 mg iodine / ml	0,64	11,6	6,1
350 mg iodine / ml	0,78	23,3	10,6

Pharmacodynamics

Yogexol is a nonionic low-osmolar iodine-containing radiopaque preparation.

Time to achieve maximum radiopaque in normal myelography - up to 30 minutes (after 1 h no longer visualized). With CT, visualization of the contrast in the thoracic region is possible within 1 hour, the cervical region - about 2 hours, basal cisterns - 3-4 hours. The contrast of joint cavities, uterine cavity, fallopian tubes, peritoneal protrusions, pancreatic and biliary ducts, bladder is achieved immediately after administration.

Pharmacokinetics:

Almost 100 percent of injected yogexol is excreted unchanged through normally functioning kidneys within 24 hours. The maximum concentration of iohexol in the urine is determined approximately 1 hour after the injection.

The half-life of the drug in patients with normal renal function is about 2 hours. There are no metabolites of the drug. The binding of yogexol to plasma proteins is small (less than 2%) and has no clinical significance.

Indications:

Omnipack® is intended for diagnostic purposes only.

Radiopaque means for use in children and adults, designed for cardioangiography, arteriography, urography, phlebography and contrast enhancement in computed tomography (CT); lumbar, thoracic and cervical myelography, CT-cisternography after subarachnoidal administration; arthrography, endoscopic retrograde pancreatography (ERGG), endoscopic retrograde cholangiopancreatography (ERCP), hysterosalpingography, herniography, sialography and gastrointestinal tract research.

Contraindications:

Hypersensitivity to the active ingredient or any auxiliary substance.

Expressed thyrotoxicosis.

Carefully:

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

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

- in the study of patients with severe cardiovascular diseases and pulmonary hypertension, because of the risk of developing hemodynamic disorders or arrhythmias;

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

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

- to prevent the development of acute renal failure after the introduction of radiopaque means should pay special attention to patients at increased risk of kidney failure and diabetes, as well as patients with paraproteinaemia (myelomatosis and macroglobulinemia Waldenstrem);

- in the 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;

- when examining patients with hypovolemia, adequate hydration should be provided, at least 100 ml every hour for 4 hours before the test and 24 hours after the test;

- In the study of patients with multiple myeloma, diabetes mellitus, impaired renal function, newborns, children under one year of age and patients, adequate hydration is necessary before and after the administration of the radiocontrast.

- Patients with diabetes mellitus metformin, before intravascular administration of iodine-containing radiocontrast agents, the drug should be discontinued for at least 48 hours before and within 48 hours after the procedure.

In emergency cases, when the kidney function is unknown, the doctor should evaluate the risk / benefit ratio of the contrast agent: stop using metformin, hydrate, monitor kidney function, monitor the appearance of the initial signs of lactic acidosis.

Pregnancy and lactation:

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.

Contrast agents are excreted to breast milk to a small extent. Therefore, the likelihood of harm to the child when breastfeeding is unlikely. However, if you need to administer the drug, stop breastfeeding before you inject the drug and do not resume at least 24 hours after the test.

Hysterosalpingography should not be performed in pregnant women and in the presence of acute pelvic peritonitis.

Dosing and Administration:

General information

The drug is intended for intravascular (intra-arterial, intravenous), intrathecal, intracavitary, oral and rectal administration. Like all preparations for parenteral administration, Omnipac® should be inspected visually before use for insoluble particles, discoloration, and packaging integrity problems.

Omnipac® should be injected into the syringe immediately before use. Unused remnants of the drug for further use are not allowed.

Additional instructions for using the autoinjector

Bottles with a radiocontrast agent with a capacity of 500 ml should be used only together with the corresponding autoinjector. In this case, a single puncture of the vial plug is performed. The output tube of the autoinjector changes after each patient.

An unused preparation, left in the vial and connecting tubes, is destroyed at the end of the working day. If necessary, bottles of a smaller volume may also be used. When working with an autoinjector, follow the instructions for using it.

Do not mix Omnipack^®with other medicines (you need to use a separate syringe and needle).

Within 30 minutes after the end of the procedure, a doctor control over the patient; It is during this period that most of the adverse reactions occur.

Intrathecal administration

After myelography, the patient should be in a horizontal position for 1 hour with a raised head and chest raised to 20 °.After that, the patient can walk gently, but should not bend over. If the patient remains in bed, then within 6 hours his head and chest should remain elevated. If you suspect a low convulsive threshold, the patient should remain under medical supervision during this period of time. Outpatient patients can not be left unattended in the first 24 hours after the administration of radiopaque.

The dosage of the drug depends on the type of study, the age and body weight of the patient, the state of hemodynamics, the general state of health, as well as the methodology used and the technique for performing the study. Typically, the same concentrations of iodine and the amounts of administration of the drug are used, as with other modern iodine-containing radiopaque agents.

Recommended dosing regimen is given in the table below:

Indication / Examination		Concentration	Scope	Notes
Intravenous (iv) administration
Urography
Adults:		300 mg iodine / ml or 350 mg iodine / ml	40-80 ml 40-80 ml	AT individual cases can apply more 80 ml
Children (body weight <7 kg)		240 mg iodine / ml or 300 mg iodine / ml	4 ml / kg 3 ml / kg
Children (body weight> 7 kg)		240 mg iodine / ml or 300 mg iodine / ml	3 ml / kg 2 ml / kg	Max. 40 ml
Phlebography (lower limbs)		240 mg iodine / ml or 300 mg iodine / ml	20-100 ml per leg
Digital subtraction angiography		300 mg iodine / ml or	20-60 ml per injection
		350 mg iodine / ml	20-60 ml per injection
CT scan
Adults:		240 mg iodine / ml or 300 mg iodine / ml or 350 mg iodine / ml	100-250 ml 100-200 ml 100-150 ml	The total amount of iodine is usually 30-60 g
Children:		240 mg iodine / ml or	2-3 ml per kg of weight not more than 40 ml	In rare cases, you can apply up to 100 ml per child, but no more than
		300 mg iodine / ml	1-3 ml per kg of weight not more than 40 ml
Intraarterial (w / a) administration
Arteriography
Aortic arch		300 mg iodine / ml	30-40 ml per 1 injection	The volume of injection depends on the injection site
Selective cerebral arteriography		300 mg iodine / ml	5-10 ml per 1 injection
Aortography		350 mg iodine / ml	40-60 ml per 1 injection
Femoral arteriography		300 mg iodine / ml or 350 mg iodine / ml	30-50 ml per 1 injection
Other		300 mg iodine / ml	depends on the type of study
Cardioangiograaphasia
Adults:
Left ventricle and aorta root		350 mg iodine / ml	30-60 ml per 1 injection
Selective coronary angiography		350 mg iodine / ml	4-8 ml per injection
Children:		300 mg iodine / ml or 350 mg iodine / ml	depending on age, weight and pathology	Max. 8 ml / kg
Digital subtraction angiography		240 mg iodine / ml or	1-15 ml per injection	Depending on the injection site, it is sometimes possible to use large volumes of up to 30 ml
		300 mg iodine / ml	1-15 ml per injection
Intrathecale introduction
Lumbar and Thoracic myelography (lumbar injection)		240 mg iodine / ml	8-12 ml
Cervical myelography (lumbar injection)		240 mg iodine / ml or 300 mg iodine / ml	10-12 ml 7-10 ml
Cervical myelography (lateral cervical injection)		240 mg iodine / ml or 300 mg iodine / ml	6-10 ml 6-8 ml
CT Cisternography (lumbar injection)		240 mg iodine / ml	4-12 ml
To minimizepossible side reactions, the total dosage of iodine should not exceed 3 g
Introduction tobody
Arthrography		240 mg iodine / ml or	5-20 ml
		300 mg iodine / ml or	5-15 ml
		350 mg iodine / ml	5-10 ml
ERCP / ERGG		240 mg iodine / ml	20-50 ml
Gerniography		240 mg iodine / ml	50 ml	The dose depends on the size hernia
Hysterosalpingography		240 mg iodine / ml or 300 mg iodine / ml	15-50 ml 15-25 ml
Sialografiya		240 mg iodine / ml or 300 mg iodine / ml	0.5-2 ml 0.5-2 ml
Study gastrointestinalth tract
Oral:
Adults:	350 mg iodine / ml		individually
Children:
- esophagus	300 mg iodine / ml or		2 -4 ml / kg masses bodies	Maximum dosage of 50 ml
	350 mg iodine / ml		2-4 ml / kg masses bodies	Maximum dosage of 50 ml
Premature babies:	350 mg iodine / ml		2-4 ml / kg masses bodies
Rectal:
Children:	Breeding water to 100-150 mg iodine / ml		5-10 ml / kg masses bodies	Example: dissolve Omnipac® 240 mg iodine / ml, 300 mg iodine / ml or 350 mg iodine / ml with water 1: 1 or 1: 2
ComputerI'm a tomography
Orally:
Adults:		Dilute with water to ~ 6 mg iodine / ml	800 - 2000 ml of the diluted solution in tOne period time	Example: dissolve Omnipac® 300 mg iodine / ml or 350 mg iodine / ml with water 1:50
Children:		Dilute with water to ~ 6 mg iodine / ml	15-20 ml / kg of weight bodies divorced solution
Rectal:
Children:		Dilute with water to ~ 6 mg iodine / ml	Individually

Side effects:

Common Adverse Reactions

(for all indications for the use of iodine-containing radiocontrast agents).

The following are the possible common side effects associated with the use of non-ionic monomers. Side effects specific to a particular mode of administration, see the relevant sections. Hypersensitivity reactions can occur regardless of the dose and mode of administration, mild symptoms may be harbingers of a serious anaphylactoid reaction / shock. In this case, the administration of the radiopaque means should be immediately stopped and, if necessary, the intravascular administration of specific therapeutic agents is started.

After the administration of the iodine-containing radiopaque agent, an insignificant transient increase in the serum creatinine concentration is observed, possibly the development of contrast-induced nephropathy.

Iodism or iodine guinea pig is a rare reaction to the introduction of iodine-containing radiocontrast agents, expressed in the increase and soreness of the salivary glands after a study of up to 10 days. The reported incidence of adverse reactions is based on the primary clinical documentation and published research data, in which more than 90,000 patients participated.

The incidence of adverse events is classified as follows: very often (≥1/10), often (≥1 / 100 to <1/10), infrequently (≥1 / 1000 to <1/100), rarely (≥1 / 10000 to < 1/1000), very rarely (<1/10000), is unknown (the frequency can not be determined from the available data).

Immune system disorders

Rarely: hypersensitivity reactions (including dyspnea, rash, erythema, urticaria, pruritus, skin reactions, vasculitis, angioedema, laryngeal edema, laryngospasm, bronchospasm or noncardiogenic pulmonary edema).Reactions can occur immediately after the injection or a few days later.

Unknown: anaphylactic / anaphylactoid reaction, anaphylactic / anaphylactoid shock.

Disturbances from the nervous system

Rarely: headache.

Very rarely: dysgeusia (transient sensation of "metallic" taste in the oral cavity).

Unknown: faint.

Disorders from the cardiovascular system

Rarely: aetiology.

Vascular disorders

Very rarely: increased blood pressure, lower blood pressure.

Disorders from the gastrointestinal tract

Infrequently: nausea.

Rarely: vomiting.

Very rarely: diarrhea, pain / discomfort in the abdomen.

Unknown: an increase in the salivary glands.

General disorders and disorders at the site of administration

Often: a feeling of heat.

Rarely: fever.

Very rarely: chills.

Trauma, intoxication and complications of manipulation

Unknown: iodism.

Intravascular administration (intraarterially and intravenously)

Please read the section "Common Adverse Reactions" first. Only those undesirable reactions that occur with intravascular administration of nonionic monomeric radiopaque agents are described below.

The nature of adverse reactions that occur with intra-arterial administration depends on the site of injection and the dose administered. Selective angiography and other procedures in which high concentrations of radiopaque means reach a particular organ can be accompanied by development complications in this body.

Immune system disorders

Unknown: severe skin reactions in the form of pustules or bullae.

Endocrine disorders

Unknown: thyrotoxicosis, transient hypothyroidism.

Disorders of the psyche

Unknown: confusion.

Disturbances from the nervous system

Rarely: dizziness.

Very rarely: convulsions, impaired consciousness, encephalopathy, stupor, disorders in the sensory sphere (including hypoesthesia), paresthesia, tremor.

It is not known: transient motor dysfunction (including speech disturbance, aphasia, dysarthria), transient memory loss, disorientation, coma and retrograde amnesia.

Disturbances on the part of the organ of sight

Unknown: transient cortical blindness.

Hearing and balance disorders

Unknown: Transient hearing loss.

Disorders from the cardiovascular system

Rarely: arrhythmia (including bradycardia, tachycardia).

Very rarely: myocardial infarction.

Unknown: severe complications (including cardiac arrest, cardiac arrest and respiration), spasm of the coronary arteries, chest pain.

Vascular disorders

Very rarely: "hot flashes".

Unknown: shock, arterial spasm, ischemia, thrombophlebitis and thrombosis.

Disturbances from the respiratory system and the mediastinum

Rarely: cough.

Very rarely: dyspnea, noncardiogenic pulmonary edema.

Unknown: severe symptoms and signs of respiratory disorders, bronchospasm, laryngospasm, asthma attack.

Disorders from the gastrointestinal tract

Rarely: diarrhea.

Unknown: exacerbation of pancreatitis, acute pancreatitis.

Disturbances from the skin and subcutaneous tissue

Unknown: bullous dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash, accompanied by eosinophilia and general symptoms, exacerbation of psoriasis.

Disturbances from musculoskeletal and connective tissue

Unknown: arthralgia.

Disorders from the kidneys and urinary tract

Rarely: renal dysfunction, including acute renal failure.

General disorders and reactions at the injection site

Often: a feeling of heat.

Infrequent: pain and discomfort.

Rarely: asthenic condition (eg, malaise, fatigue). Unknown: reactions at the injection site (including extravasation), back pain.

Intrathecal administration

Please read the section "Common Adverse Reactions" first. Only those undesirable reactions that occur when intrathecal administration of non-ionic monomeric radiopaque substances are described below are described.

In case of intrathecal administration, unwanted reactions can occur after several hours or even days after the diagnostic procedure. The frequency of adverse reactions is the same as after lumbar puncture. Headache, nausea, vomiting, or dizziness can be largely due to a decrease in pressure in the subarachnoid space due to leakage of the cerebrospinal fluid through the puncture hole. To minimize the pressure drop, you must avoid removing too much cerebrospinal fluid.

Disorders of the psyche

Unknown: confusion.

Disturbances from the nervous system

Very often: headache (can be severe and prolonged).

Infrequent: Aseptic meningitis (including chemical meningitis).

Rarely: convulsions, dizziness.

Unknown: abnormalities in the electroencephalogram, meningism, transient encephalopathy, including temporary memory loss, coma, stupor and retrograde amnesia, motor dysfunction (including speech disorders, aphasia, dysarthria), paresthesia, hypesthesia and impaired sensory function.

Disturbances on the part of the organ of sight

Unknown: transient cortical blindness, photophobia.

Hearing and balance disorders

Unknown: Transient hearing loss.

Disorders from the digestive system

Often: nausea, vomiting.

Disorders from the musculoskeletal system and connective tissue

Rarely: pain in the neck, back pain.

Unknown: muscle spasms.

General disorders and reactions at the injection site

Rarely: pain in the limbs.

Unknown: reactions at the injection site.

Intracavernal administration

Please read the section "Common Adverse Reactions" first. Only those unwanted reactions are described below,which arise when intracavitary administration of nonionic monomeric radiopaque substances.

Endoscopic retrograde cholangiopancreatography (ERCP)

Infringements from digestive system

Often: pancreatitis, increased concentration of amylase in the blood.

Oral administration

Disorders from the digestive system

Very often: diarrhea.

Often: nausea, vomiting.

Infrequent: pain in the abdomen.

Hysterosalpingography (GHA)

Disorders from the digestive system

Very often: pain in the lower abdomen.

Arthrography

Disorders from the musculoskeletal system and connective tissue

Unknown: arthritis.

General disorders and reactions at the injection site

Very often: pain.

Gerniography

General disorders and reactions at the injection site

Unknown: pain after the procedure.

Description of some unwanted reactions

It was reported thromboembolic complications in contrast cardioangiography and angiography of the cerebral, renal and peripheral arteries. The introduction of radiopaque means could contribute to the development of these complications.

Cases are described cardiological complications, including acute myocardial infarction, during or after coronary angiography with radiopaque enhancement. In elderly patients or in the presence of severe coronary artery disease, unstable angina and left ventricular dysfunction, the risk of cardiac complications is increased. In very rare cases, the radiocontrast can pass through the blood-brain barrier into the cerebral cortex, which can lead to transient neurological reactions, in particular, convulsions, transient motor or sensory disturbances, confusion, memory loss and encephalopathy.

When anaphylactoid reaction and shock can develop severe arterial hypotension and associated with her hypoxic encephalopathy, renal and hepatic insufficiency.

In some cases, extravasation of radiopaque means there are local pain and swelling, but these symptoms are resolved without consequences. Cases of inflammation, tissue necrosis and the appearance of compartmental syndrome are described.

Pediatric Use

There have been reports of cases of transient hypothyroidism in children, including preterm and newborns,after the introduction of iodine-containing radiocontrast agents.

Premature babies are particularly sensitive to iodine effects.

The case of transient hypothyroidism in a preterm child was reported. The mothers of this child reintroduced Omnipac®. An adequate rehydration is necessary before and after the introduction of radiopaque means, this is especially important for young children. Nephrotoxic drugs should be discontinued. Reduced glomerular filtration, characteristic of young children, can also lead to a delayed removal of radiopaque substances.

Overdose:

Overdose is unlikely in patients with normal renal function. In the case of using high doses of the drug, the duration of the study (the half-life of the drug is approximately 2 hours) has a large effect on the kidneys. There is no specific antidote, treatment is symptomatic, hemodialysis is possible.

Interaction:

When used concomitantly with antipsychotic drugs, analgesics and antidepressants, Omnipac® can reduce the convulsive threshold, increasing the risk of adverse reactions.

The use of Omnipac® in patients with diabetic nephropathy who take biguanides (metformin), can lead to a transient disruption of kidney function and the development of lactic acidosis. As a precaution, it is necessary to stop taking biguanides 48 hours before the test and resume after complete stabilization of kidney function.

Patients who took less than 2 weeks before the study of interleukin-2 are prone to an increased incidence of delayed adverse reactions (flu-like conditions or skin reactions).

In patients taking beta-adrenoblockers, the manifestations of anaphylaxis with the use of yogexol can be atypical and mistaken for vagal reactions.

Special instructions:

Preparation of the patient and the procedure for administering the drug

Before applying the contrast agent, you need to obtain accurate information about the patient, including laboratory data (including serum creatinine, electrocardiogram, history and pregnancy). Before the study, the patient should be eliminated, disturbances of the water-electrolyte balance and ensure sufficient supply of fluid and electrolytes.

This is especially true for patients with multiple myeloma, diabetes, polyuria or gout, as well as newborns, children under one year, and elderly patients.

2 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.

Patients who are afraid of waiting before the procedure need premedication with sedatives.

The risk of developing severe adverse reactions to Omnipak® is small.

However, all iodine-containing contrast agents can cause anaphylactoid reactions or other manifestations of hypersensitivity. For this reason, it is necessary to foresee the sequence of medical measures in case of their occurrence and to have the necessary drugs and equipment for immediate medical care.

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

You should use a separate syringe and needle to insert Omnipac® and do not mix it with other drugs.

In comparison with ionic preparations, nonionic radiopaqueunitsless affect in vitro on the blood coagulation system. When performing angiographic studies, you should carefully follow their methodology and often flush the catheters (for example, 0.9% solution of sodium chloride with the addition of heparin) to minimize the risk of thrombosis and embolism associated with the intervention.

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

All iodine-containing contrast agents distort the results of radioisotope studies of shieldsidn(the iodine binding capacity of the thyroid tissue remains reduced within 2 weeks after administration).

High concentrations of contrast agent in blood plasma or urine can affect the results of biochemical tests to determine the concentration of bilirubin, proteins or inorganic substances (eg, iron, copper, calcium and phosphates). Therefore, such tests should not be performed on the day of the study.

Patients with diabetes mellitus metformin, before intravascular administration of iodine-containing radiocontrast agents, the drug should be discontinued for at least 48 hours before and within 48 hours after the procedure.

Measures for the prevention of adverse reactions:

- Identification of patients at high risk.

- Ensuring adequate hydration of the patient, if necessary, by continuous intravenous infusion, started before the administration of the drug and continuing until it is excreted by the kidneys.

- Prevention of additional burden on the kidneys arising from the use of nephrotoxic drugs, oral medicines for cholecystography, renal artery compression, renal artery angioplasty, or extensive surgical operations, before removing contrast media from the body.

- Repeated radiopaque studies should be performed no earlier than when the kidney function is restored to its original level.

- In patients with impaired renal and hepatic function, the clearance of the drug can be significantly reduced.

- Patients on hemodialysis can be given radiopaque agents provided dialysis is performed immediately after the examination.

Intrathecal administration:

After myelography, the patient should be in a horizontal position for 1 hour with a raised head and chest raised to 20 °. After that, the patient can walk gently, but should not bend over. If the patient remains in bed, then for 6 hours his head and chest should remain elevated. If you suspect a low convulsive threshold, the patient should remain under medical supervision during this period of time. Outpatient patients can not be left unattended in the first 24 hours after the administration of radiopaque.

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

It is not recommended to drive vehicles or work with any other mechanisms during the first 24 hours after intrathecal administration of contrast media.

Form release / dosage:

Solution for injection, 240 mg iodine / ml, 300 mg iodine / ml and 350 mg iodine / ml.

Packaging:

For the dosage of 240 mg iodine / ml

To 20 ml in a colorless glass bottle (Hebrew Farm, type I), sealed with a stopper of chlorobutyl rubber and crimped with an aluminum cap, top covered with a snap-off plastic lid.

25 vials of 20 ml together with the instruction for use are placed in a cardboard box.

50 ml per vial of polypropylene PPM R021, sealed with a plug of chlorobutyl rubber and closed with a screwed polypropylene cover, provided with a ring that provides control of the first opening, and on top with a ring for tearing off the sealing gasket.

The vial has a label, the lower part of which is used to suspend the vial.

10 polypropylene bottles along with the instructions for use are placed in a cardboard box.

For the dosage of 300 mg iodine / ml

To 20 ml in a colorless glass bottle (Hebrew Farm, type I), sealed with a stopper of chlorobutyl rubber and crimped with an aluminum cap, top covered with a snap-off plastic lid.

25 bottles of 20 ml together with the instructions for use are placed in a cardboard box.

To 50 or 100 ml in a bottle of polypropylene PPM R021, sealed with a plug of chlorobutyl rubber and closed with a screwed polypropylene cover, provided with a ring for monitoring the first opening, and on top with a ring for tearing off the sealing gasket.

A 50 ml and 100 ml bottle contains a label, the lower part of which is used to suspend the bottle.

10 polypropylene bottles along with the instructions for use are placed in a cardboard box.

For a dosage of 350 mg iodine / ml

To 20 ml in a colorless glass bottle (Hebrew Farm, type I), sealed with a stopper of chlorobutyl rubber and crimped with an aluminum cap, top covered with a snap-off plastic lid.

25 bottles of 20 ml together with the instructions for use are placed in a cardboard box.

By 50, 100, 200 or 500 ml into a bottle of polypropylene PPM R021, sealed with a plug of chlorobutyl rubber and closed with a screwed polypropylene cover, provided with a ring for monitoring the first opening, and on top with a ring for tearing off the sealing gasket.

On a bottle of 50 ml, 100 ml, 200 ml and 500 ml, there is a label, the lower part of which is used to suspend the bottle.

10 polypropylene bottles along with the instructions for use are placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 30 ° C, in a place protected from light and secondary X-rays.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N015799 / 01

Date of registration:14.05.2009

The owner of the registration certificate:JI Halskea LimitedJI Halskea Limited United Kingdom

Manufacturer: & nbsp

GE HEALTHCARE IRELAND Ireland

Representation: & nbspJI Halskea Nycomed Distribution Ltd.JI Halskea Nycomed Distribution Ltd.Russia

Information update date: & nbsp09.11.2015

Illustrated instructions

Instructions

Omnipack® (Omnipaque®)