Unipak

The medical product Unipak is used as a contrast fluid in X-ray examinations. The active ingredient, iogexol, is able to accumulate between cells, facilitating the visibility of tissues.

Unipak is available only with a prescription.

Indications Unipak

The medical product Unipak is intended for diagnostic purposes only. It is a radiopaque substance used in pediatrics and in therapeutic practice for the following diagnostic procedures:

• cardiac examination and angiography;
• examination of arteries;
• urogram;
• phlebogram;
• computed tomography method;
• myelogram of various vertebral sections;
• cisternogram;
• arthrogram;
• pancreatogram (ERPG);
• herniogram;
• hysterosalpingogram;
• sialogram;
• X-ray contrast studies of the digestive system.

Release form

Unipak is produced in the form of an injection substance - a transparent, discolored or slightly yellowish product.

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

• in ampoules of 20 ml, 5 pieces in a cardboard box;
• in bottles of 50 or 100 ml (1 bottle in a cardboard box).

Unipack with a composition of 300 or 350 mg/ml Iodine, available:

• in ampoules of 20 ml, 5 pieces in a cardboard box;
• in 200 ml bottles (1 bottle in a cardboard box).

The main ingredient is iogexol:

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

Additional components include tromethamine, sodium calcium edetate, hydrochloric acid, and injection liquid.

Pharmacodynamics

The main component is a non-ionic triiodinated, water-soluble, radiopaque substance. When administered intravenously, Unipaque does not affect most hemodynamic data, clinical, biochemical and coagulation values. The period of reaching the maximum radiocontrast during a standard myelography procedure is up to half an hour (visibility is cancelled after 60 minutes). During a computed tomography procedure, the contrast is visible:

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

Contrast of joint capsules, uterus, appendages, biliary system or urinary bladder is performed immediately after fluid injection.

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Pharmacokinetics

Almost 100% of the substance administered intravenously is excreted unchanged by fully functioning kidneys. The excretion process lasts about a day.

The maximum content of the active ingredient in urine is determined 60 minutes after administration.

The half-life of the drug in people with normal functioning kidneys can be 120 minutes.

The metabolic products of Unipak are unknown.

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

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Dosing and administration

The medical liquid Unipak can be administered into the body intraarterially, intravenously, intrathecally, orally, rectally, and also into cavities. It is used both in pediatric and therapeutic practice.

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

Indications	Content of the substance	Dosage on One introduction	Peculiarities
Urography procedure Adult patients Child less than 7 kg The child is 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 (maximum quantity - 40 ml)	Sometimes a dosage greater than 80 ml is used.
Phlebogram of leg vessels	240 mg Iodine /ml or 300 mg Iodine /ml	20-100 ml – one limb
Digital subtraction angiogram procedure	300 mg Iodine /ml or 350 mg Iodine /ml	20-60 ml
Contrast enhancement method 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 (standard) 3–60 g. Sometimes use is allowed up to 100 ml

Indications	Content of the substance	Dosage on One introduction	Peculiarities
Arteriography procedure Aortic arch Selective cerebral angiogram Aortogram Angiogram of the femoral arterial vessels	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 the examination method	The amount of medication in one injection depends on the zone of administration
Cardioangiogram Adult patient Left ventricular cavity and aortic root Selective coronary angiogram Child	350 mg Iodum /ml 350 mg Iodum /ml 300 mg Iodum/ml, or 350 mg Iodum /ml	30-60 ml 4-8 ml Depending on age and 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 depending on the injection area. (up to 30 ml)

Indications	Content of the substance	Dosage per administration	Peculiarities
Lumbar-thoracic myelogram Cervical myelogram Cervical myelogram (lateral cervical injection) CT cisternogram	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	Content of the substance	Dosage per administration	Peculiarities
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
ERPG/ERCP	240 mg Iodum /ml	20-50 ml
Herniogram	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
Diagnostics of the digestive system Internal reception Adult patient Child esophagus Weakened child Rectal use Child	350 mg Iodum /ml 300 mg Iodum/ml, or 350 mg Iodum /ml 350 mg Iodum /ml Amount diluted with water to contain 100–150 mg Iodum/ml	Prescribed individually 2–4 ml/kg of weight 2–4 ml/kg of weight 5-10 ml/kg of weight	Maximum dosage - 50 ml For example: dilute the preparation 240 or 300, or 350 with water 1:1 or 1:2
Contrast enhancement for CT Internal use Adult patient Child Rectal use Child	Dilute with water to a state of 6 mg Iodum /ml Dilute with water to 6 mg Iodum /ml Dilute with water to 6 mg Iodum /ml	800–2000 ml of solution over a specific period 15–20 ml solution/kg weight Determined by an individual method	For example: dissolve the drug 300 or 350 with water 1:50

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Use Unipak during pregnancy

It has not yet been established whether this substance is safe for use during pregnancy and breastfeeding. For this reason, the drug is used only when absolutely necessary, assessing the possible risk of using the drug with its diagnostic benefits.

Studies have shown that radiocontrast fluids in small quantities can enter breast milk. The risk of exposure to the child is poorly understood, so experts advise temporarily stopping breastfeeding the day before the introduction of Unipaque. Resumption of feeding is possible no less than 24 hours after the radiocontrast examination.

Contraindications

• Individual sensitivity to the components of the radiopaque agent, as well as to other iodine-containing agents.
• Pronounced signs of thyrotoxicosis.
• Presence of limited or general infectious diseases (with myelography).
• Repeated emergency intrathecal (into the cerebrospinal fluid) administration of a substance after unsuccessful myelography.
• Epilepsy and infectious diseases of the brain (with subarachnoid injection).
• Pregnancy and breastfeeding period.
• Concomitant administration of Unipaque and glucocorticoid drugs.

Side effects Unipak

General adverse reactions: shortness of breath, swelling of the larynx, allergic reaction, convulsive syndrome, headache, slow heartbeat, decreased or increased blood pressure, metallic taste in the mouth, dyspepsia, fever, iodine mumps, iodism.

• With intra-arterial administration: arterial spasm, allergic reaction, dizziness, convulsive syndrome, sensory failure, fear and anxiety, paresthesia, cerebral ischemia, nystagmus, hemiparesis. Less common: visual impairment, arrhythmia, renal failure, dyspepsia, colic, myocardial ischemia, bronchospasm, thyrotoxicosis, vascular damage at the injection site, pulmonary edema.
• When administered intravenously: joint pain, thrombus formation, phlebitis, thrombosis.
• When administered intrathecally (may appear several hours or even days after the injection): drowsiness, neuralgia, disorientation, meningitis, hypertension or hypotension, tinnitus, temporary deterioration of vision, vomiting, problems with urination, muscle pain, feeling of heat, loss of appetite.
• With intracavitary administration: development of an allergic reaction, dyspepsia, epigastric pain, arthritis, inflammation and tissue necrosis in the injection area.

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Overdose

The risk of an overdose of Unipak is considered minimal, but a prolonged procedure using a large volume of the drug can lead to a disorder in the functional capacity of the urinary system.

Often, an increase in undesirable side effects is possible.

In pediatrics, it is especially important to avoid using excessive amounts of the substance, especially when performing repeated procedures.

No special means have been found to neutralize the negative effects of medical contrast fluid. Symptomatic therapy methods are usually used.

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Interactions with other drugs

It is not recommended to use Unipak together with hypoglycemic medications – guanine derivatives, for example, Metformin or Buformin, as this can provoke a deterioration in renal function.

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

Neuroleptic drugs, antidepressants, and medications that stimulate the central nervous system when used in combination with contrast may increase the risk of developing an epileptic syndrome.

Combined use with blood pressure lowering medications may lead to persistent hypotension.

The contrast agent must not be mixed in the same injection with any other drugs, regardless of the purpose for which they are administered.

Any remaining liquid must not be used for re-administration.

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Storage conditions

Unipack is stored in the original packaging, at a temperature of no more than +25°C, out of the reach of children. Unipack must not be frozen.

Shelf life

The shelf life of the substance is up to 3 years.