Unipack

The medical tool Unipack is used as a contrast fluid for X-ray examinations. Active active ingredient - yogexol - is able to accumulate between cells, facilitating the visibility of tissues. 

Unipack is released strictly in the presence of a prescription.

Indications Unipack

Medical tool Unipack is provided only for diagnosis. It is a radiopaque substance that is used in pediatrics and in therapeutic practice for the following diagnostic procedures:

• cardiovascular and angiography;
• examination of arteries;
• urogram;
• phlebogram;
• method of computed tomography;
• myelogram of different vertebral parts;
• cisternogram;
• arthrogram;
• pancreatogram (ERGG);
• herniogram;
• hysterosalpingogram;
• sialogram;
• radiocontrast studies of the digestive system. 

Release form

Unipack is made in the form of an injectable substance - a clear, discolored or slightly yellowed, remedy.

Unipack, which contains 240 mg / ml Iodine, is released:

• in am. For 20 ml, 5 pieces in a cardboard bundle;
• in flakonchikah to 50 or 100 ml (1 flakonchik in a cardboard bundle).

Unipack with a composition of 300 or 350 mg / ml Iodine is released:

• in am. 20 ml, 5 pieces in a carton;
• in flakonchikah for 200 ml (1 flakonchik in a cardboard bundle).

The main ingredient is yogexol:

• 0.518 g = 240 mg / ml Iodine;
• 0.647 g = 300 mg / ml Iodine;
• 0.755 g = 350 mg / ml iodine.

 Additional components are represented by tromethamine, edetate sodium-calcium, hydrochloric acid, injection liquid. 

Pharmacodynamics

The main component is a non-ionic triiodic, water-soluble, radiopaque substance. When administered intravenously, Unipack does not affect most hemodynamic data, clinical, biochemical and coagulation values. The period of achieving the maximum radiopaque in the standard procedure of myelography is maximum to half an hour (after 60 minutes visibility is canceled). When carrying out the procedure of computed tomography, the contrast is visible:

• when examining the thoracic part of the spine - for 60 minutes;
• when examining the cervical region - for 120 minutes;
• when examining basal cisterns - from 3 to 4 hours.

The contrast of the articular bags, uterus, appendages, biliary system or bladder is carried out immediately after the injection of liquid.

[1],

Pharmacokinetics

Practically 100% of the substance administered by intravenous infusion is excreted unchanged by means of fully functioning kidneys. The elimination process lasts about a day.

The limiting content of the active ingredient in the urinary fluid is determined 60 minutes after the administration.

The half-life of the medicinal substance in people with normal working kidneys can be 120 minutes.

Unipack exchange products are unknown.

The binding of the active ingredient to the serum proteins is clinically insignificant, since it is less than 2%, so this figure is not taken into account. 

[2], [3]

Dosing and administration

Medical fluid Unipack can be injected into the body intra-arterially, intravenously, intrathecally, orally, rectally, and also into cavities. It is used both in pediatric and in therapeutic practice.

During the injection of the substance, the patient should lie on the couch. The dosage of the liquid is selected depending on the type of diagnostic technique, the age category and weight of the patient, his overall health and manipulation technique.

Indications	Substance content	The dosage for One introduction	Features
Urography procedure Adult patients Child less than 7 kg Child over 7 kg	300 mg Iodine / ml or 350 mg Iodine / ml; 240 mg Iodine / ml or 300 mg Iodine / ml; 240 mg Iodine / ml or 300 mg Iodine / ml	40-80 ml 4 ml / kg 3 ml / kg 3 ml / kg 2 ml / kg (the limiting amount is 40 ml)	Sometimes use a dosage of more than 80 ml
Phlebogram of the vessels of the legs	240 mg Iodine / ml or 300 mg Iodine / ml	20-100 ml - one limb
The procedure for obtaining a digital subtraction angiogram	300 mg Iodine / ml or 350 mg Iodine / ml	20-60 ml
Method of contrast enhancement for CT Adult patient Child	240 mg Iodine / ml or 300 mg Iodine / ml, or 350 mg Iodine / ml 240 mg Iodine / ml or 300 mg Iodine / ml	100-250 ml 100-200 ml 100-150 ml 2-3 ml / kg of weight (maximum volume - 40 ml) 1-3 ml / kg of weight	Total iodine volume (standard) 3-60 g. Sometimes it is allowed to use before 100 ml

Indications	Substance content	The dosage for One introduction	Features
Procedure of arteriography Aortic arch Selective cerebral angiogram Aortogram Angiogram of the femoral arteries	300 mg Iodine / ml 300 mg Iodine / ml 350 mg Iodine / ml 300 mg Iodine / ml or 350 mg Iodine / ml 300 mg Iodine / ml	30-40 ml 5-10 ml 40-60 ml 30-50 ml Depends on survey technique	The amount of medication in one injection depends on the zoning of the administration
Cardioangiogram Adult patient The cavity of the left ventricle and the root of the aorta Selective coronarogram Child	350 mg Iodum / ml 350 mg Iodum / ml 300 mg Iodum / ml, or 350 mg Iodum / ml	30-60 ml 4-8 ml Depends on age, weight category And a specific disease (maximum volume - 8 mg / kg of weight)
Digital Angiogram	240 mg Iodum / ml, or 300 mg Iodum / ml	1-15 ml	The dosage can be adjusted from the injection zone (up to 30 ml)

Indications	Substance content	Dosage per administration	Features
Lumbar-thoracic zone myelogram Cervical zone myelogram  Cervical myelogram (lateral cervical injection) CT tracer	240 mg Iodum / ml  240 mg Iodum / ml, or 300 mg Iodum / ml 240 mg Iodum / ml, or 300 mg Iodum / ml 240 mg Iodum / ml	8-12 ml  10-12 ml 7-10 ml 6-10 ml 6-8 ml 4-12 ml

Indications	Substance content	Dosage per administration	Features
The procedural method with obtaining an arthrogram	240 mg Iodum / ml, or 300 mg Iodum / ml, or 350 mg Iodum / ml	5 - 20 ml 5 - 15 ml 5 - 10 ml
ERGG / ERCPR	240 mg Iodum / ml	20-50 ml
Gerniogram	240 mg Iodum / ml	50 ml	The volume may depend on the size of the hernia
Hysterosalpingogram	240 mg Iodum / ml, or 300 mg Iodum / ml	15-50 ml 15-25 ml
Sialogram	240 mg Iodum / ml, or 300 mg Iodum / ml	0.5-2 ml 0.5-2 ml
Diagnosis of the digestive system Internal Reception Adult patient Child esophagus Weakened child Rectal application Child	350 mg Iodum / ml  300 mg Iodum / ml, or 350 mg Iodum / ml  350 mg Iodum / ml  The amount diluted with water to a content of 100-150 mg Iodum / ml	Assigned individually  2-4 ml / kg body weight 2-4 ml / kg body weight 5-10 ml / kg of weight	The maximum dosage is 50 ml  For example: dilute the drug 240 or 300, or 350 water 1: 1 abo 1: 2
Contrast enhancement for CT Internal application Adult patient Child Rectal use Child	Dilute with water to the 6 mg Iodum / mL  Dilute with water until 6 mg Iodum / ml Dilute with water until 6 mg Iodum / ml	800-2000 ml of r-ra for a specific period  15-20 ml rp / kg body weight  It is determined by an individual method	For example: dissolve the drug 300 or 350 with water 1:50

[5]

Use Unipack during pregnancy

Until now, it has not been established whether the substance is safe for use in the period of baby-bearing and breast-feeding. For this reason, the remedy is used only when absolutely necessary, assessing the possible risk from using the tool with its use for diagnosis.

Studies have shown that radiocontrast liquids in small amounts can fall into the composition of breast milk. The risk of exposure to a child is poorly understood, therefore, experts advise temporarily to stop breastfeeding on the eve of the introduction of Unipack. Renewal of feeding is possible not less than a day after the radiocontrast study. 

Contraindications

• Individual sensitivity to the components of radiopaque substances, as well as to other iodine-containing products.
• Expressed signs of thyrotoxicosis.
• The presence of limited or common infectious diseases (with myelography).
• Repeated urgent intrathecal (in liquor) administration of the substance after unsuccessful myelography.
• Epilepsy and infectious diseases of the brain (with subarachnoid injection).
• Pregnancy and lactation.
• Simultaneous administration of Unipack and glucocorticoid drugs.

Side effects Unipack

General undesirable manifestations: dyspnea, swelling of the larynx, allergic reaction, convulsive syndrome, headache, slowing of the heart, lowering or raising blood pressure, metallic taste in the oral cavity, indigestion, fever, iodine guinea pig, iodism.

• With intra-arterial introduction: arterial spasm, allergic reaction, dizziness, convulsive syndrome, failure of sensitivity, a sense of fear and anxiety, paresthesia, brain ischemia, nystagmus, hemiparesis. Less commonly - impaired vision, arrhythmia, renal failure, dyspepsia, colic, cardiac muscle ischemia, bronchospasm, thyrotoxicosis, vascular lesion at the site of injection, pulmonary edema.
• With intravenous administration: pain in the joints, thrombosis, phlebitis, thrombosis.
• When injected intrathecally (may appear several hours or even a day after the injection): drowsiness, neuralgia, orientation disorders, meningitis, hypertension or hypotension, ringing in the ears, temporary impairment of vision, vomiting, trouble urinating, muscle pain, feeling hot, worsening appetite.
• When intrapulmonary administration: the development of an allergic reaction, dyspepsia, epigastric pain, arthritis, inflammation and necrosis of tissues in the injection zone.

[4]

Overdose

The risk of an overdose of Unipack is considered minimal, but a prolonged procedure with the use of a large volume of the drug can lead to a disruption of the functional capacity of the urinary system.

It is often possible to increase unwanted side effects.

In pediatrics, it is especially important not to allow the use of overestimated amounts of a substance, especially when performing repeated procedures.

A special agent, neutralizing the negative effect of medical contrast fluid, was not found. Usually, methods of symptomatic therapy are undertaken.

[6]

Interactions with other drugs

It is not advisable to use Unipack and hypoglycemic medications - guanine derivatives, for example, Metformin or Buformin, as it can provoke impairment of renal function.

The combination of contrasting fluids and glucocorticosteroid hormones is contraindicated when contrast is introduced into the cerebrospinal fluid.

Neuroleptics, antidepressants, medications for CNS stimulation, when used in conjunction with contrast, may increase the risk of epileptic syndrome.

Combined use with medications that reduce blood pressure, can lead to persistent hypotension.

Contrast agent can not be mixed in one injection with any other drugs, regardless of the purpose for which they are administered.

The liquid residues can not be used for repeated administration. 

[7]

Storage conditions

Unipack is stored in factory packaging, with temperatures not exceeding + 25 ° C, in the absence of free access of children. You can not let Unipack freeze.

Shelf life

Shelf life of the substance is up to 3 years.