Omnipak

Omnipak – X-ray contrast not ionic triyodirovanny contrast agent.

Form of release and structure

Dosage form – solution for injections: transparent, colourless or yellowish liquid (on 140 mg: in glass bottles – on 50 ml, in a cardboard pack of 10 pieces, on 200 ml, in a cardboard pack of 6 pieces; in polypropylene bottles on 50 ml, in a cardboard pack of 10 pieces; po180 mg: in glass or propylene bottles on 10, 15 or 50 ml, in a cardboard pack of 10 pieces; on 240 mg: in glass bottles – in a cardboard pack of 10 pieces on 10 ml and 50 ml, 6 pieces on 20 ml and 200 ml, 6 or 25 pieces on 20 ml; in polypropylene bottles on 10 ml, 20 ml or 50 ml, in a cardboard pack of 10 pieces; on 300 mg: in glass bottles – in a cardboard pack of 10 pieces on 10 ml, 6 or 25 pieces on 20 ml, 6 or 10 pieces on 100 ml or 10 pieces on 50 ml; in polypropylene bottles on 10, 20, 40, 50, 100 or 200 ml, in a cardboard pack of 10 pieces; on 350 mg: in glass bottles – in a cardboard pack of 10 pieces on 10 ml, 6 or 25 pieces on 20 ml, 10 pieces on 50 ml, 10 pieces on 100 ml or 6 pieces on 200 ml; in polypropylene bottles on 20, 40, 50, 100 or 200 ml, in a cardboard pack of 10 pieces).

Active agent of Omnipak – йогексол (INN), its contents in 1 ml of solution depends on concentration of iodine in drug:

• 302 mg at 140 mg of iodine in 1 ml;
• 388 mg at 180 mg of iodine in 1 ml;
• 518 mg at 240 mg of iodine in 1 ml;
• 647 mg at 300 mg of iodine in 1 ml;
• 755 mg at 350 mg of iodine in 1 ml.

Auxiliary components: sodium-calcium эдетат (EDTA), Acidum hydrochloricum, трометамол, water for injections.

Indications to use

Omnipak's use is shown to adults and children before conducting the following diagnostic testings:

• The Computer Tomography (CT) – for contrast strengthening;
• Cardioangiography, urography, arteriography, flebografiya;
• Miyelografiya of lumbar, chest and cervical department of a backbone;
• KT-tsisternografiya at subarachnoidal introduction;
• Artrografiya, endoscopic retrograde pankreatografiya (ERPT), endoscopic retrograde holangiopankreatografiya (ERHPG), salpingografiya, sialografiya;
• Digestive tract researches.

Contraindications

• The expressed thyrotoxicosis;
• Infectious pathologies of a local or system etiology;
• Pregnancy period;
• Cerebral infections, epilepsy – for subarachnoidal introduction;
• Intrathecal repeated immediate introduction after unsuccessfully carried out miyelografiya;
• Hypersensitivity to drug components.

With care it is necessary to apply Omnipak at patients with the instruction in the anamnesis of undesirable reactions (including a bronchospasm, an allergy) on use of iodinated contrast means, at a pheochromocytoma, pulmonary hypertensia, dekompensirovanny pathologies of cardiovascular system, bronchial asthma, a multiple myeloma, Valdenstrem's macroglobulinemia, a pollinosis, food allergy, dehydration, a liver failure, multiple sclerosis, an obliterating thromboangitis (Thrombangiitis obliterans), acute cerebral pathologies, tumors of a brain, epilepsy, the expressed atherosclerosis, a sickemia, acute thrombophlebitis, renal failures, a moderate thyrotoxicosis, a diabetes mellitus, alcoholism, drug addiction, at advanced age, in the period of breastfeeding.

Besides, careful control when carrying out lumbar punctures against the background of local or system infections is necessary.

Route of administration and dosage

Omnipak is intended for intravenous, intra arterial, intracavitary, intrathecal, rectal administration, oral administration.

Before use it is necessary to check integrity of packaging, to be convinced of lack of insoluble particles or discolorations in drug.

Solution is gathered in the syringe before direct introduction, the drug rest in a bottle is utilized.

Introduction should be made at horizontal position of the patient, then within 0,5 hours it is necessary to control his state as during this period development of side reactions is possible.

Omnipak's dose is appointed individually depending on a type of a research, a condition of a hemodynamics, age, body weight, the state of health of the patient, and also the applied method and technology of performance of a research.

After intrathecal introduction for performance of a miyelografiya the patient needs to be within 1 hour at rest, in a prone position with the headboard raised on 20 °. Inspected medical control within 6 hours in case of suspicion on a low threshold of development of spasms is required. The patient should avoid body tilts.

Side effects

The cumulative side effects at Omnipak's use usually have reversible character and moderate degree of manifestation:

• Feeling of passing metal smack in an oral cavity, a heat in all body;
• Nausea, vomiting; seldom – pains or feeling of discomfort in a stomach;
• Hypersensitivity reactions: moderately expressed disturbances of breath in the form of an asthma, a bronchospasm; skin reactions – an itch, rash, urticaria, an erythema, a Quincke's disease; seldom – throat hypostasis, a fluid lungs, an acute anaphylaxis;
• Allergic reactions: Stephens-Johnson's syndrome, toxic epidermal necrosis;
• Vazovagalny reactions in the form of bradycardia and arterial hypotension;
• Others: seldom – temperature increase, a convulsive syndrome, temporary decrease in hearing or deafness after a miyelografiya, an iodism (an iodic mumps).

The side effects of Omnipak connected with intra arterial introduction:

• The selection angiography and other researches with administration of drug of high concentration: often – pain on the vessel course, a caumesthesia, increase in level of creatinine of blood serum (passing); dysfunction of the inspected body; very seldom – a renal failure;
• Introduction to brain, coronary or renal arteries: perhaps – an arterial spasm, tranzitorny ischemia in the inspected body, disturbance of a cordial rhythm, decrease in sokratitelny function of a myocardium, myocardium ischemia; very seldom – neurologic reactions in the form of passing disturbances of motive function and sensitivity, spasms; in isolated cases accumulation of drug in a cerebral cortex leads to a cortical blindness, passing disturbances of space orientation.

Side reactions at intrathecal introduction:

• Often: nausea, vomiting, headache (sometimes strong), dizziness;
• Sometimes: moderate local pain, radicular pains in an injection site, paresthesia, an onychalgia, spasms;
• In some cases: symptoms of irritation of a firm meninx – a meningism, photophobia;
• Seldom: passing dysfunction of the central nervous system – a disorientation, disorder of motive functions and sensitivity, a spasm, change of indicators of the electroencephalogram;
• Very seldom: meningitis.

At intravenous administration development of postflebografichesky thrombophlebitises, thromboses, arthralgias is seldom or never possible.

At intracavitary introduction except exceptional cases of development of the general hypersensitivity reactions to Omnipak side effects depend on a research method:

• Endoscopic retrograde pankreatokholangiografiya: often – slight increase of activity of amylase in blood serum; in rare instances – development of a pancreatonecrosis;
• Oral administration: perhaps – gastrointestinal frustration;
• Gisterosalpingografiya (GSG): often – a passing moderate abdominal pain (lower parts);
• Artrografichesky research: often – pain; seldom – arthritises; perhaps – development of infectious arthritis;
• Gerniografichesky research: perhaps – development of moderate pain reaction;
• Extravasated introduction of contrast means (ekstravazation): seldom – development of passing local pain and hypostasis; perhaps – an inflammation and a necrosis of fabrics.

Special instructions

Omnipak's use is possible in the presence of the complete information about a clinical condition of the patient, including datas of laboratory about water and electrolytic balance, creatinine level in blood serum, electrocardiograms, allergies in the anamnesis, pregnancy existence.

Disturbance of water and electrolytic balance should be eliminated before carrying out a research and to provide receipt of enough liquid and electrolytes before administration of drug, especially at patients of advanced age, children (including newborn and chest), at a diabetes mellitus, a polyuria, gout, a multiple myeloma, a renal failure.

Meal should be stopped in 2 hours prior to administration of solution.

It is not recommended to carry out preliminary tests with use of small doses of drug for definition of individual sensitivity.

Premedication is shown by sedative drugs to patients with sensation of fear from the forthcoming procedure.

The room for medical procedures has to be equipped with the equipment and medicines necessary for holding medical actions at development of anaphylactoid reactions and other manifestations of hypersensitivity.

Omnipak it is impossible to mix in one syringe with other medicines.

For decrease in risk of thromboses and an embolism angiographic researches should be carried out in the conditions of careful observance of a technique, to watch sterility of the used catheters.

Drug influences results of tests of function of a thyroid gland, at high concentration of X-ray contrast means in urine and a blood plasma distortion of results of biochemical researches on determination of level of concentration of proteins, bilirubin, inorganic matters is possible.

Use of guanyl guanidines needs to be stopped in 48 hours prior to administration of drug and to renew after stabilization of function of kidneys. For ensuring adequate hydration at the patient with a diabetes mellitus it is possible to use intravenous infusion, having begun it before administration of solution it is necessary to continue before full removal by drug kidneys.

Carrying out repeated X-ray contrast researches is possible only after recovery of function of kidneys to initial level.

At a severe form of a simultaneous abnormal liver function and kidneys it is necessary to observe extra care as at the patient the clearance of contrast means is considerably reduced. The patients who is on a hemodialysis can conduct X-ray contrast researches on condition of ensuring dialysis right after the research.

Within 24 hours after Omnipak's introduction it is not recommended to manage vehicles or mechanisms.

Medicinal interaction

Omnipak pharmaceutical is incompatible with drugs of other groups, besides, at intrathecal introduction – with glucocorticosteroids.

Against the background of use of guanyl guanidines (Metforminum) at a diabetes mellitus the risk of a passing renal failure and development of lactic acidosis increases.

Reception interleykina-2 during the period less than in 2 weeks prior to administration of drug can increase the frequency of the delayed side effects in the form of skin reactions or a grippopodobny state.

At simultaneous use with derivatives of a fenotiazin and other neuroleptics, tetracyclic antidepressants, monoamine oxidase inhibitors, analeptics, stimulators of the central nervous system the risk of epileptic seizures increases.

Reception of beta adrenoblockers and other antihypertensives increases probability of development of arterial hypotension, also against the background of reception of beta adrenoblockers of display of an anaphylaxis at patients can be mistakenly taken for vagal reactions as have atypical character.

Drug strengthens nephrotoxic effect of other medicines.

Terms and storage conditions

To store in the unavailable to children, protected from light place at a temperature up to 30 °C. To protect from secondary x-ray emission.

Period of validity – 3 years.