Diascan
UkraineTable of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DIASKAN (DIASKAN)
Composition:
Active substance: iopamidol;
1 ml of solution contains iopamidol 612 mg, equivalent to 300 mg of iodine, or
1 ml of solution contains iopamidol 755 mg, equivalent to 370 mg of iodine;
Excipients: trometamol, calcium disodium edetate, diluted hydrochloric acid, water for injections.
Pharmaceutical form. Injection solution.
Main physicochemical properties: clear solution ranging from colorless to pale yellow.
Diaskan, 300 mg/ml:
osmotic pressure at 37 °C – 635.9 mOsmol/kg;
viscosity at 37 °C – 4.5 mPa·s.
Diaskan, 370 mg/ml:
osmotic pressure at 37 °C – 834.8 mOsmol/kg;
viscosity at 37 °C – 9.0 mPa·s.
Pharmacotherapeutic group. Contrast agents. Iodinated radiographic contrast agents. ATC code V08A B04.
Pharmacological properties.
Pharmacodynamics.
Iopamidol is a contrast agent belonging to the new generation of non-ionic compounds, whose solubility is due to the presence of hydrophilic substituents in the molecule. As a result, the solution has low osmolarity compared to ionic compounds.
The efficacy of iopamidol as a radiographic contrast agent has been demonstrated in neuroradiology, angiography, phlebography, arthrography, urography, cerebral angiography, left ventricular ventriculography, and coronary angiography. Its toxicity, particularly cardiotoxicity and central nervous system (CNS) toxicity, is lower than that of ionic contrast agents.
Pharmacokinetics.
The pharmacokinetics of iopamidol follows an open two-compartment pharmacokinetic model with first-order elimination. Iopamidol distributes into the extracellular fluid but does not penetrate cells.
Excretion is almost entirely renal. Less than 1% of the administered dose is excreted in feces within 72 hours after administration. Elimination is rapid; up to half of the administered dose may be excreted in urine within the first two hours after administration.
There is no evidence of biotransformation.
Plasma protein binding is negligible.
Clinical characteristics.
Indications.
This medicinal product is intended for diagnostic use only.
Visipaque, 300 mg/ml: lumbar and thoracocervical myelography, cerebral angiography, peripheral angiography and venography, contrast enhancement during computed tomography, urography, arthrography.
Visipaque, 370 mg/ml: peripheral arteriography, angiocardiography and left ventriculography, cerebral arteriography, retrograde aortography, selective renal arteriography, selective visceral angiography, digital subtraction angiography, excretory urography.
Contraindications.
Hypersensitivity to the active substance or to any of the excipients of the product.
Intrathecal administration
Concomitant intrathecal administration of corticosteroids with iopamidol is contraindicated.
Due to overdose risk, immediate repeat myelography in case of technical failure is contraindicated.
Special precautions.
Do not use if the solution contains visible solid particles. After opening the vial, the solution must be used immediately. Any unused medicinal product should be disposed of in accordance with local requirements.
Iodine-containing contrast media may react with metallic surfaces containing copper (e.g., brass); therefore, the use of such equipment should be avoided if its surfaces may potentially come into contact with iopamidol.
Interaction with other medicinal products and other forms of interaction.
After administration of iopamidol, the thyroid gland's ability to uptake radioisotopes is reduced for 2–6 weeks.
Thyroid function testing: the use of iodine-containing contrast agents may interfere with thyroid function tests that depend on iodine measurement, such as protein-bound iodine and radioactive iodine uptake. As a result, these tests will not accurately reflect thyroid function for up to 16 days after administration of iodine-containing contrast. Thyroid function tests that do not depend on iodine measurement, such as resin T3 uptake, and total or free thyroxine (T4) levels, are not affected.
To prevent lactic acidosis in diabetic patients receiving oral antidiabetic agents of the biguanide class, treatment with biguanides should be discontinued 48 hours before contrast agent administration and resumed only after kidney function has been checked and found to be unchanged from pre-procedure levels.
In emergency situations, when renal function is impaired or unknown, the physician must weigh the risks and benefits of contrast agent examination. Metformin should be discontinued at the time of contrast agent administration. After the procedure, the patient should be monitored for signs of lactic acidosis. Metformin treatment should be resumed 48 hours after contrast agent administration, provided that serum creatinine/eGFR levels have not changed compared to pre-imaging levels.
Patients with normal renal function may continue taking metformin in their usual regimen.
Cases of arterial thrombosis have been reported following papaverine administration after prior injection of iopamidol.
Patients with cardiovascular disease and/or arterial hypertension who are receiving diuretics, ACE inhibitors and/or beta-blockers have an increased risk of adverse reactions following administration of iodine-containing contrast agents.
In patients receiving β-blockers, there is an increased risk of anaphylactic reactions. β-blockers may impair the response to treatment of bronchospasm induced by contrast agents.
Administration of vasoconstrictive agents enhances the neurological effects of intra-arterial contrast agents.
Renal intoxication has been observed in patients with hepatic dysfunction who received oral cholecystographic agents in combination with intravascular contrast agents. Therefore, administration of intravascular contrast agents should be delayed in patients who have recently received oral cholecystographic agents.
Contrast agents may interfere with laboratory tests for bilirubin, proteins, or inorganic compounds such as iron, copper, calcium, and phosphates. Therefore, analysis of these parameters should not be performed on the day of contrast agent administration.
After administration of iopamidol, patients undergoing treatment with interleukin-2 may develop erythema, high fever, or influenza-like symptoms.
Intrathecal administration
Avoid the use of neuroleptics due to their lowering of the seizure threshold. The same applies to analgesics, antiemetics, antihistamines, and sedatives of the phenothiazine group. If possible, such medications should be discontinued at least 48 hours before contrast agent administration and their use resumed no earlier than 24 hours thereafter.
Special precautions for use.
Diagnostic procedures involving the use of any radiographic contrast agent must be performed under the supervision of trained personnel who are thoroughly familiar with the specific procedure to be carried out. Immediate resuscitation measures must be readily available. During the examination, venous access should be maintained to allow for prompt management in case of an adverse reaction.
After completion of the examination, the patient should remain under medical supervision for at least 30 minutes.
Care must be taken during administration of the contrast agent to avoid extravasation. Local tissue irritation may occur due to perivascular infiltration of the contrast medium.
Patients with epilepsy, including those with a history of seizures, should continue their appropriate anticonvulsant therapy. In some cases, anticonvulsant prophylaxis may be advisable up to 48 hours before the procedure. If a seizure occurs during the procedure, intravenous diazepam or phenobarbital is recommended.
Iopamidol should be used with caution in patients with hypercalcemia and cerebrovascular disorders.
The risk associated with a given procedure may be increased in conditions such as progressive atherosclerosis and arterial hypertension.
Administration of iodine-containing contrast agents may exacerbate symptoms of myasthenia gravis.
Some patients may require general anesthesia. However, in such patients, a higher incidence of adverse reactions has been reported, likely due to the hypotensive effect of anesthetics.
Like all other contrast agents, this product may cause anaphylactic reactions or other allergic manifestations (nausea, vomiting, dyspnea, skin flushing, urticaria, hypotension). Severe reactions, including fatal outcomes, have been reported. The agent should be used with particular caution in patients with known or suspected hypersensitivity, asthma, or previous adverse reactions to contrast media. Administration to such patients should only occur when the expected benefit clearly outweighs the risk of complications. Premedication with antihistamines or corticosteroids may be considered to prevent or minimize potential allergic reactions in these patients. The risk of bronchospasm-related reactions is higher in asthmatic patients, especially those taking beta-blockers, after contrast agent administration.
Patients with suspected or known hypersensitivity to contrast agents should not undergo sensitivity testing, as severe or fatal reactions to contrast media cannot be predicted by such tests. Patients should also be informed that allergic reactions may develop within several days after the procedure, and in such cases, immediate medical attention is required.
Particular attention should be paid to patients with moderate to severe renal impairment (evidenced by elevated blood urea levels). Significant changes in renal function can be minimized by adequate hydration. Renal function in such patients should be monitored closely after administration of the agent. Pre-existing renal insufficiency may lead to acute kidney injury following contrast agent administration.
Potentially nephrotoxic drugs should not be administered to patients with renal dysfunction until the contrast agent has been fully eliminated from the body. Renal function parameters should be monitored after the procedure in these patients. Administration of the contrast agent should be postponed until renal function has been restored. Patients undergoing dialysis may receive contrast agents such as iopamidol, which can be easily removed by dialysis.
Patients with hepatorenal insufficiency should only be examined if the procedure is essential. Repeat examinations should be performed no sooner than 5–7 days apart.
Caution is required when administering the agent to patients with renal insufficiency and diabetes mellitus. Maintaining adequate hydration is important in these patients to minimize renal function disturbances.
Renal impairment in diabetic patients is one of the risk factors for contrast-induced nephropathy. This may trigger lactic acidosis in patients taking metformin (see section "Interaction with other medicinal products and other forms of interaction").
Patients should be adequately rehydrated prior to radiographic procedures. Rehydration is not recommended in patients with severe hepatic or cardiac dysfunction, myeloma, diabetes, polyuria or oliguria, hyperuricemia, infants, elderly patients, or those with severe systemic diseases. Fluid intake should not be restricted, and any fluid and electrolyte imbalances should be corrected before administration of the agent.
Patients with Waldenström's macroglobulinemia, multiple myeloma, or severe hepatic and renal dysfunction are also at increased risk; adequate hydration is recommended after contrast agent administration in these cases.
Contrast agents may induce sickle cell crisis in individuals homozygous for sickle cell anemia when administered intravenously or intra-arterially. To prevent crisis in patients with sickle cell anemia, adequate hydration should be ensured and the lowest possible volume of low-concentration contrast agent should be used.
Patients with congestive heart failure should be monitored for several hours after the procedure to detect delayed hemodynamic disturbances, which may be related to transient increases in circulating osmotic load.
In patients undergoing angiocardiographic procedures, special attention should be paid to the condition of the right ventricle and pulmonary circulation. Administration of organic iodine solutions may provoke bradycardia and systemic hypotension in patients with right ventricular insufficiency or pulmonary hypertension. Right ventricular angiography should only be performed when absolutely indicated.
Ventricular arrhythmias may rarely occur during intracardiac and/or coronary arteriography.
Examination with iodine-containing contrast enhancement should be performed with caution in patients with hyperthyroidism, suspected hyperthyroidism, or autonomously functioning thyroid nodules, as thyroid storm has been reported after administration of iodine-containing contrast agents. The agent should be used cautiously in patients with hyperthyroidism. Recurrence of hyperthyroidism is possible in patients previously treated for Graves' disease.
In patients scheduled for thyroid imaging with radioactive iodine, it should be noted that thyroid iodine uptake will be reduced for several days (up to two weeks) after administration of iodine-containing contrast agents, which are excreted renally.
Patients with pheochromocytoma should be pre-treated with α-adrenergic blockers, as severe hypertensive crisis may occur following intravascular administration of iopamidol.
During angiographic procedures, platelet aggregation or vascular wall injury/perforation may occur; therefore, catheter manipulation time and duration of contrast agent injection should be minimized. Test injections are recommended to confirm proper catheter placement.
When examining the aortic arch, the catheter tip should be carefully positioned to avoid arterial hypotension, bradycardia, and CNS injury due to excessive pressure transmitted from the injector pump to the brachiocephalic arterial branches.
Angiography should not be performed in patients with homocystinuria, as it may increase the risk of thrombosis and embolism.
In patients undergoing peripheral angiography, pulsation should be present in the artery into which the contrast agent is injected. Angiography should be performed with extreme caution and only when absolutely indicated in patients with thromboangiitis obliterans or at risk of infection with severe ischemia.
Particular caution is required in patients undergoing venography when phlebitis, severe ischemia, local infection, or complete venous occlusion is suspected.
Serious neurological events have been observed after direct injection of contrast agent into cerebral arteries or vessels supplying the spinal cord, or during angiocardiography due to inadvertent filling of carotid arteries.
The agent should be used cautiously in elderly patients, patients with symptomatic cerebrovascular disease, recent stroke, blood-brain barrier disruption, increased intracranial pressure, suspected intracranial tumor, abscess or hematoma/hemorrhage, history of seizures, chronic alcoholism, or multiple sclerosis. Patients with these conditions are at increased risk of neurological complications.
Intra-arterial injections of contrast agents may cause vasospasm and cerebral ischemic events.
Intrathecal administration
Careful assessment of benefit-risk ratio is necessary in patients with a history of epilepsy, presence of blood in cerebrospinal fluid, or local or systemic infection with potential bacteremia.
If cerebrospinal fluid blockage is present, the contrast agent should be removed as completely as possible.
Use in special populations
Children, including infants
Infants (age <1 year), especially newborns, are extremely sensitive to electrolyte imbalances and hemodynamic changes. Therefore, the agent should be used with particular caution, considering recommended dosages, procedural specifics, and the patient's clinical status.
In pediatric examinations, including infants, fluid intake should not be restricted prior to administration of hypertonic contrast solution. Any pre-existing fluid and electrolyte imbalances should be corrected.
In pediatric radiology, administration of contrast agent into the right heart chamber in cyanotic newborns with pulmonary hypertension and cardiac dysfunction should be performed with great caution.
In newborns, especially premature infants, thyroid function should be evaluated (usually TSH and T4 levels) 7–10 days and within 1 month after administration of iodine-containing contrast agents due to the risk of iodine-induced hypothyroidism.
Elderly patients
Elderly patients are at particular risk of adverse reactions due to age-related decline in physiological functions, especially when high doses of contrast agents are used. Myocardial ischemia, significant arrhythmias, ventricular extrasystoles, and acute kidney injury are more likely in these patients.
Women of reproductive age
Radiological examinations in women should, whenever possible, be scheduled during the preovulatory phase of the menstrual cycle and avoided during pregnancy.
When performing any radiological examination in women of reproductive age, with or without contrast agents, radiation protection measures should be used.
Severe skin adverse reactions
Severe skin adverse reactions (SCARs), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (Lyell's syndrome or TEN), and acute generalized exanthematous pustulosis (AGEP), which may be life-threatening, have been reported in patients receiving iopamidol (see section "Adverse reactions"). Patients should be informed about the signs/symptoms prior to treatment initiation and closely monitored for severe skin reactions. If signs/symptoms suggestive of such reactions occur, further administration of iopamidol should be discontinued. If a patient develops a severe skin adverse reaction to iopamidol, the agent must not be re-administered to that patient in the future.
Use during pregnancy or breastfeeding
Radiological examinations in women should, whenever possible, be performed during the preovulatory phase of the menstrual cycle and avoided during pregnancy. Furthermore, since the safety of iopamidol in pregnant women has not been established, it should only be used if the physician considers the procedure necessary. In addition to the undesirability of fetal radiation exposure, the potential risk of iodine-containing contrast agents should also consider the fetal thyroid gland's sensitivity to iodine when assessing benefit-risk balance.
Iodine-containing radiographic contrast agents pass into breast milk in small amounts. Animal studies indicate that iopamidol is not toxic when administered orally. Based on current experience, it is unlikely that the agent will harm the infant. Breastfeeding need not be interrupted.
Ability to affect reaction speed when driving vehicles or operating machinery
There are no data on the effect on the ability to drive vehicles or operate machinery. However, due to the risk of early reactions occurring within one hour after the last intravascular injection, driving or operating machinery is not recommended during this period. After intrathecal administration, driving or operating machinery is not recommended for 6 hours.
Administration method and dosage.
Route of administration
- Intracavitary.
- Intraarterial.
- Intravenous.
- Intra-articular.
- Intrathecal.
- Intracisternal.
Dosage
Discan, 300 mg/ml
| Procedure |
Drug dosage |
| Lumbar myelography |
5–10 mL for adults |
| Thoracocervical myelography |
5–10 mL for adults |
| Cerebral angiography |
5–10 mL* for adults, |
| Peripheral arteriography |
20–50 mL* for adults, |
| Venography |
20–50 mL* for adults, |
| Computed tomography enhancement |
for adults: head scanning 50–100 mL, |
| Intravenous urography |
40–80 mL for adults |
| Arthrography |
1–10 mL for adults |
* If necessary, repeat.
**Dosage of the drug for children is calculated according to body weight and age.
Diaskan, 370 mg/ml
| Procedure |
Drug dosage |
| Peripheral arteriography |
20–50 mL* for adults, |
| Venography |
20–50 mL* for adults, |
| Angiocardiography and left ventriculography |
30–80 mL* for adults, |
| Coronary arteriography |
4–8 mL* for adults |
| Retrograde aortography |
30–80 mL* for adults, |
| Selective coronary arteriography: |
2–5 mL for adults |
| Digital subtraction angiography: |
50 mL for adults, |
| Digital subtraction angiography: left ventriculography |
25 mL for adults, |
| Excretory intravenous urography |
40–80 mL for adults |
| Selective renal arteriography |
5–10 mL for adults, |
| Selective visceral angiography:
|
30–70 mL, |
* If necessary, repeat.
** According to the child's body weight.
Dosage depends on the type of examination, age, body weight, cardiac function, renal function, general condition of the patient, and the technique used. As with other contrast agents, the dosage should be minimal but sufficient to achieve the desired diagnostic result.
Non-ionic contrast agents have less anticoagulant activity in vitro than ionic agents. Therefore, angiography should be performed very carefully. Non-ionic contrast agents must not be left in the injection syringe in contact with blood. Intravascular catheters must be frequently flushed to minimize coagulation, which has occasionally led to severe thromboembolic complications after administration of the agent. Factors such as duration of the procedure, catheter and syringe material, underlying disease, and concomitant medications may contribute to the development of thromboembolic events. Thus, careful performance of angiographic techniques is recommended, including close attention to guidewire and catheter manipulation, use of various systems and/or three-way stopcocks, frequent flushing of the catheter with heparinized saline, and minimizing the duration of the procedure.
Clinical studies indicate better tolerability of warmed contrast medium; therefore, it is recommended to heat the contrast agent to body temperature prior to administration.
No other drugs or contrast agents should be mixed with iopamidol injection solution.
Lumbar myelography
Slow subarachnoid injection is performed through a fine spinal needle into one of the lower lumbar interlaminar spaces (L3-L4 or L4-L5). Optimal contrast is achieved immediately after injection; therefore, imaging should be performed without delay.
Thoracocervical myelography
After slow subarachnoid injection, the patient should be turned onto the side and the head tilted downward by 10°–20° under fluoroscopic control. This allows monitoring of the contrast column's movement toward the dorsal region. If cervical region imaging is required, the contrast agent should first be introduced into the cervical region, followed by examination of the dorsal segments where it gradually dilutes. The agent may also be administered suboccipitally or via lateral cervical puncture. Care must be taken to prevent intracranial migration of the contrast medium.
After completion of direct cervical or lumbocervical procedures:
- Elevate the head of the table steeply (at a 45° angle) for approximately two minutes to allow the contrast medium to drain toward the caudal end.
- Avoid excessive or particularly active movements or straining by the patient; keep the patient under close observation, in quiet surroundings, and in a head-up position, especially during the first few hours.
- Monitor patients suspected of having a low seizure threshold during this period.
- The patient should remain supine and maintain bed rest during this time.
- Encourage the patient, if possible, to take oral fluids and food.
Cerebral angiography
Any of the modern techniques are suitable for radiological visualization of cerebral vessels using Diaskan, 300 mg/mL. Carotid and vertebral angiography performed via catheterization or percutaneous injection requires rapid injection, which may be repeated if necessary.
Peripheral arteriography and phlebography (venography)
Percutaneous injection into the appropriate blood vessel is used for visualization of peripheral arteries and veins.
Contrast enhancement during computed tomography
Contrast enhancement in brain scanning may be achieved from one to three minutes after intravenous injection. The agent is also used for whole-body scanning after intravenous administration as a bolus, by drip infusion, or by a combination of both methods.
Urography
The contrast agent is administered intravenously and rapidly excreted by the kidneys. Patients with severe renal insufficiency should undergo urography using high doses.
Arthrography
Visualization of joint cavities and articular surfaces can be achieved by single- or double-contrast examination.
Children
The drug is used in pediatric practice. It is essential to clearly identify the group of children at increased risk of adverse reactions, namely those with: bronchial asthma; heart disease associated with cyanosis of the skin; congestive heart failure; history of allergic reactions; plasma creatinine levels above 1.5 mg/dL; and children under 12 months of age.
Overdose
Dosages exceeding those specified in the instructions are not recommended, as they may lead to life-threatening adverse reactions.
If necessary, hemodialysis may be used to remove iopamidol from the body. Treatment of overdose is directed toward supporting all vital functions and timely symptomatic therapy.
Intravascular
In case of accidental intravascular overdose, loss of water and electrolytes should be compensated by infusion. Renal function should be monitored for at least three days.
Intrathecal
Signs of intrathecal overdose may include ascending hyperreflexia or tonic-clonic seizures progressing to generalized seizures, and in severe cases of central nervous system involvement—hyperthermia, stupor, and respiratory depression.
Adverse Reactions
The use of iodine-containing contrast agents may cause adverse reactions, which are usually mild to moderate in severity and transient in nature. However, severe and life-threatening reactions have been reported, occasionally resulting in fatal outcomes.
Anaphylactic reactions (anaphylactoid reactions/hypersensitivity) may manifest as mild localized or more widespread angioneurotic edema, tongue swelling, laryngospasm or laryngeal edema, dysphagia, pharyngitis, sensation of throat tightness, throat and pharyngeal pain, cough, conjunctivitis, rhinitis, sneezing, feeling of warmth, increased sweating, weakness, dizziness, pallor, dyspnea, wheezing, bronchospasm, and moderate hypotension. Skin reactions may include various types of rashes, generalized erythema, widespread vesicles, urticaria, and pruritus. These reactions, which occur independently of the administered dose and route of administration, may represent early signs of the initial stage of shock. Administration of the contrast agent must be stopped immediately, and specific treatment should be initiated intravenously if necessary.
Following intravascular administration, reactions typically occur within minutes after injection. However, delayed-type reactions, which are usually cutaneous, may appear predominantly within 2–3 days, and less frequently within 7 days, after contrast agent administration.
After subarachnoid administration, most adverse reactions manifest with a delay of several hours due to slow absorption from the injection site and systemic distribution. Reactions usually occur within 24 hours after injection.
More serious cardiovascular-related reactions, such as vasodilation with marked arterial hypotension, tachycardia, dyspnea, agitation, cyanosis, and loss of consciousness, potentially progressing to respiratory and/or cardiac arrest, may lead to fatal outcomes.
These reactions may develop rapidly and require full and intensive cardiopulmonary resuscitation.
Initial signs of circulatory arrest may occur either immediately with or without preceding respiratory symptoms or other signs and symptoms described above.
Intravascular administration, adults
Adverse reactions are classified by system organ classes and frequency of occurrence: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), and frequency not known (cannot be estimated from available data).
| Organ system class |
Adverse reactions |
|||
| Clinical trials |
Post-marketing surveillance |
|||
| Common |
Uncommon |
Rare |
Frequency not known |
|
| Blood and lymphatic system disorders |
thrombocytopenia |
|||
| Immune system disorders |
anaphylaxis, anaphylactoid reactions |
|||
| Psychiatric disorders |
confusion |
|||
| Nervous system disorders |
headache |
dizziness, taste alteration |
paraesthesia |
coma, transient ischaemic attack, decreased level of consciousness or loss of consciousness, seizures |
| Eye disorders |
transient blindness, visual disturbances, conjunctivitis, photophobia |
|||
| Cardiac disorders |
cardiac arrhythmias such as extrasystoles, atrial fibrillation, ventricular tachycardia and ventricular fibrillation* |
bradycardia |
myocardial ischaemia, myocardial infarction, heart failure, cardiopulmonary failure, tachycardia |
|
| Vascular disorders |
arterial hypotension, hypertension, hyperaemia |
circulatory collapse or shock |
||
| Respiratory, thoracic and mediastinal disorders |
pulmonary oedema, asthma, bronchospasm |
respiratory arrest, breathing difficulties, acute respiratory distress syndrome, respiratory distress, apnoea, laryngeal oedema, dyspnoea |
||
| Gastrointestinal disorders |
nausea |
vomiting, diarrhoea, abdominal pain, dry mouth |
hypersalivation and salivary gland enlargement |
|
| Skin and subcutaneous tissue disorders |
rash, urticaria, pruritus, erythema, increased sweating |
facial swelling, mucocutaneous syndrome** |
||
| Musculoskeletal and connective tissue disorders |
back pain |
muscle spasms |
musculoskeletal pain, muscle weakness |
|
| Renal and urinary disorders |
acute renal failure |
|||
| General disorders |
feeling of warmth |
chest pain, injection site pain***, fever, feeling of cold |
chills, pain, malaise |
|
| Investigations |
increased blood creatinine |
ECG changes, including ST segment depression |
||
* Cardiac reactions may occur as a result of the hazardous procedure of coronary catheterization; these complications include thrombosis and embolism of the coronary artery.
** As with other iodine-containing contrast agents, very rare cases of cutaneous-mucosal syndromes, including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), and erythema multiforme, have been reported after administration of iopamidol.
*** Pain and swelling at the injection site may occur. In most cases, this is due to extravasation of the contrast medium. These reactions are usually transient and resolve without complications. However, inflammation and even skin necrosis have been observed in very rare cases. Isolated cases of extravasation leading to compartment syndrome have been reported.
Intravascular administration, children
The frequency and severity of adverse reactions in children are similar to those in adults.
Intrathecal administration, adults
| Organ system class |
Adverse reactions |
|||
| Clinical trials |
Post-marketing surveillance |
|||
| Very common |
Common |
Uncommon |
Frequency not known |
|
| Infections and infestations |
aseptic meningitis, bacterial meningitis due to unsafe procedure |
|||
| Immune system disorders |
anaphylaxis, anaphylactoid reactions* |
|||
| Psychiatric disorders |
confusional state, disorientation, excitation, restlessness |
|||
| Nervous system disorders |
headache |
coma, paralysis, seizures, loss of consciousness, decreased level of consciousness or unconsciousness, meningism, dizziness, paraesthesia, hypoesthesia |
||
| Eye disorders |
transient blindness |
|||
| Cardiac disorders |
arrhythmia |
|||
| Vascular disorders |
hyperemia |
arterial hypertension |
||
| Respiratory, thoracic and mediastinal disorders |
respiratory arrest, dyspnoea |
|||
| Gastrointestinal disorders |
nausea, vomiting |
|||
| Skin and subcutaneous tissue disorders |
rash |
|||
| Musculoskeletal and connective tissue disorders |
back pain, neck pain, limb pain, feeling of heaviness |
|||
| General disorders |
hyperthermia, malaise, chills |
|||
*Anaphylaxis (anaphylactoid reactions/hypersensitivity) is possible. Severe anaphylactoid reactions with circulatory disturbances and decreased arterial pressure, leading to loss of consciousness or cardiac arrest and life-threatening shock, occur much less frequently after subarachnoid administration than after intravascular administration.
Most reactions occur several hours after contrast administration due to slow absorption from the site of injection and distribution throughout the body.
Elevated blood amylase levels are common after ERCP. Very rare cases of pancreatitis have been reported.
Reactions reported in connection with arthrography are usually manifestations of irritation superimposed on pre-existing tissue inflammation.
Systemic hypersensitivity is rare, usually mild, and manifests as skin reactions. However, the possibility of severe anaphylactoid reactions cannot be excluded.
Serious skin adverse reactions (SCAR), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), have been reported with the use of iopamidol (see section "Special precautions for use").
Skin and subcutaneous tissue disorders: Frequency unknown – acute generalized exanthematous pustulosis.
Nervous system disorders following intravascular administration: Frequency unknown – hemiplegia.
Cardiac disorders: Frequency unknown – Quincke's syndrome.
Reporting of adverse reactions following marketing authorization is important. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.
Shelf life.
4 years.
Use immediately after opening.
Storage conditions.
Store in the original packaging, protected from light and X-ray radiation.
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Incompatibilities.
No medicinal products should be added to contrast agents.
Packaging.
50 ml or 100 ml in a vial; 1 vial per cardboard pack.
Prescription status. Prescription only.
Manufacturer.
Sanochemia Pharmazeutika GmbH
Sanochemia Pharmazeutika GmbH
Manufacturer's address.
Landeggerstrasse 7, 2491 Neufeld an der Leitha, Austria
Landeggerstrasse 7, 2491 Neufeld an der Leitha, Austria
Marketing Authorization Holder.
M. Biotech LIMITED
M. Biotech LIMITED
Address of the Marketing Authorization Holder.
Gladstone House, 77-79 High Street, Egham TW20 9HY, Surrey, United Kingdom
Gladstone House, 77-79 High Street, Egham TW20 9HY, Surrey, United Kingdom