VISIPAQUE

The dosage may vary depending on the type of examination, the age, weight, cardiac output and general condition of the patient and the technique used. Usually approximately the same iodine concentration and volume is used as with other iodinated X-ray contrast media in current use, but adequate diagnostic information has also been obtained in some studies with iodixanol injection with somewhat lower iodine concentration.

Adequate hydration should be assured before and after administration as for other contrast media. The product is for intravenous, intra- arterial and intrathecal use, and for use in body cavities. The following dosages may serve as a guide.

The doses given for intra-arterial use are for single injections that may be repeated. Indication/Investigation Concentration Volume Intra-arterial use Arteriographies Adults Selective cerebral 270/320(1) mg I/ml 5 - 10 ml per inj Aortography 270/320 mg I/ml 40 - 60 ml per inj.

Peripheral 270/320 mg I/ml 30 - 60 ml per inj. a. DSA 270 mg I/ml 10 - 40 ml per inj. Cardioangiography Adults Left ventricle and aortic root inj. 320 mg I/ml 30 - 60 ml/inj. Selective coronary arteriography 320 mg I/ml 4 - 8 ml/inj. Children 320 mg I/ml Depending on age, weight and pathology (recommended max total dose 10 ml/kg) (1) Both strengths are documented, but 270 mg I/ml is recommended in most cases.

Indication/Investigation Concentration Volume Intravenous use Urography Adults 270/320 mg I/ml 40 – 80 ml(2) Children < 7 kg 270/320 mg I/ml 2 – 4 ml/kg Children > 7 kg 270/320 mg I/ml 2 – 3 ml/kg All doses depending on age, weight and pathology (max.

50 ml). Venography Adults 270 mg I/ml 50 - 150 ml/leg CT-enhancement Adults CT of the head 270/320 mg I/ml 50 – 150 ml CT of the body 270/320 mg I/ml 75 – 150 ml Children CT of the head and body 270/320 mg I/ml 2–3 ml/kg up to 50 ml (in a few cases up to 150 ml may be given) Intrathecal use Lumbar and thoracic myelography (lumbar injection) 270 mg I/ml or 320 mg I/ml 10 – 12 ml(3) 10 ml(3) Cervical myelography (cervical or lumbar injection) 270 mg I/ml or 320 mg I/ml 10 – 12 ml(3) 10 ml(3) (2) 80 ml may be exceeded in selected cases.

2 g iodine should not be exceeded. g. backflow into the vagina (up to 40 ml has been studied). 10-240 ml has been studied Rectal use Children 270/320 mg I/ml 30 – 400 ml has been studied For elderly patients, patients with hepatic and/or renal impairment, the usual/proposed doses for adults can be used.

Below are listed possible side effects in relation with radiographic procedures which include the use of VlSIPAQUE. Undesirable effects associated with Visipaque are usually mild to moderate and transient in nature. Serious reactions as well as fatalities are only seen on very rare occasions, these may include acute-on-chronic renal failure, acute renal failure, anaphylactic or anaphylactoid shock, hypersensitivity reaction followed by cardiac reactions (Kounis’ syndrome), cardiac or cardio-respiratory arrest and myocardial infarction.

Cardiac reaction may be promoted by the underlying disease or the procedure. Hypersensitivity reactions may present as respiratory or cutaneous symptoms like dyspnoea, rash, erythema, urticaria, pruritus, skin reactions angioneurotic oedema, hypotension, fever, laryngeal oedema, bronchospasm or pulmonary oedema.

In patients with autoimmune diseases cases of vasculitis and SJS-like syndrome were observed. They may appear either immediately after the injection or up to a few days later. Hypersensitivity reactions may occur irrespectively of the dose and mode of administration and mild symptoms may represent the first signs of a serious anaphylactoid reaction/shock.

Administration of the contrast medium must be discontinued immediately and, if necessary, specific therapy instituted via the vascular access. Patients using beta blockers may present with atypical symptoms of hypersensitivity which may be misinterpreted as a vagal reaction.

A minor transient increase in serum creatinine is common after iodinated contrast media, but is usually of no clinical relevance.

The frequencies of undesirable effects are defined as follows:

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 not known (cannot be estimated from the available data). The listed frequencies are based on internal clinical documentation and published studies, comprising more than 48,000 patients.

Intravascular administration:

Blood and lymphatic system disorders Not known: Thrombocytopenia Immune system disorders: Uncommon: Hypersensitivity Not known: Anaphylactoid reaction, anaphylactoid shock; Psychiatric disorders: Very rare: Agitation, anxiety Not known: Confusional state Nervous system disorders: Uncommon: Headache Rare: Dizziness Very rare: Cerebrovascular accident, sensory abnormalities including taste disturbance, amnesia, paraesthesia, syncope.

Not known:

Coma, motor dysfunction, disturbance in consciousness, convulsion, transient contrast induced encephalopathy (including hallucination), tremor.

Eye disorders:

Very rare: Transient cortical blindness, visual impairment Cardiac disorders: Rare: Arrhythmia (including bradycardia, tachycardia), myocardial infarction Very rare: Cardiac arrest Not known: Cardiac failure, Ventricular hypokinesia, myocardial ischaemia, cardio- respiratory arrest, conduction abnormalities, coronary artery thrombosis, angina pectoris, spasm of coronary arteries..

Vascular disorders:

Uncommon: Flushing Rare: Hypotension Very rare: Hypertension, ischaemia Not known: Arterial spasm, thrombosis, thrombophlebitis, shock.

Respiratory, thoracic and mediastinal disorders:

Rare: Cough Very rare: Dyspnoea Not known: Pulmonary oedema, respiratory arrest, respiratory failure.

Gastrointestinal disorders:

Uncommon: Nausea, vomiting Very rare: Abdominal pain/discomfort Not known: Acute pancreatitis, pancreatitis aggravated, salivary gland enlargement Skin and subcutaneous system disorders Uncommon: Rash, pruritus, urticaria Very rare: angioedema, erythema Not known: Bullous dermatitis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, acute generalised exanthematous pustulosis, drug rash with eosinophilia and systemic symptoms, drug eruption, dermatitis allergic, skin exfoliation Musculoskeletal and connective tissue disorders: Very rare: Back pain, muscle spasm Not known: Arthralgia Renal and urinary disorders: Very rare: Impairment of renal function including acute renal failure General disorders and administration site conditions: Uncommon: Feeling hot, chest pain.

g. malaise, fatigue) Injury, poisoning and procedural complications: Not known: Iodism Intrathecal administration: Undesirable effects following intrathecal use may be delayed and present some hours or even days after the procedure.

The frequency is similar to lumbar puncture alone. Meningeal irritation giving photophobia and meningism and frank chemical meningitis have been observed with other non-ionic contrast media. The possibility of an infective meningitis should also be considered.

Immune system disorders:

Not known: Hypersensitivity, including anaphylactic/ anaphylactoid reactions Nervous system disorders: Uncommon: Headache (may be severe and lasting) Not known: Dizziness, transient contrast induced encephalopathy (including amnesia, hallucinations, confusion) Gastrointestinal disorders: Uncommon: Vomiting Not known: Nausea Musculoskeletal and connective tissue disorders: Not known: Muscle spasm General disorders and administration site conditions: Not known: Shivering, pain at injection site Hysterosalpingography (HSG): Immune system disorders: Not known: Hypersensitivity Nervous system disorders: Common: Headache Gastrointestinal disorders: Very common: Abdominal pain Common: Nausea Not known: Vomiting Reproductive system and breast disorders: Very common: Vaginal haemorrhage General disorders and administration site conditions: Common: Pyrexia Not known: Shivering, injection site reaction Arthrography: Immune system disorders: Not known: Hypersensitivity, including anaphylactic/ anaphylactoid reactions General disorders and administration site conditions: Common: Injection site pain Not known: Shivering Examination of the GI tract: Immune […]

Special precautions for use of non-ionic contrast media in general:

Hypersensitivity: A positive history of allergy, asthma, or untoward reactions to iodinated contrast media indicates a need for special caution. Premedication with corticosteroids or histamine H1 and H2 antagonists might be considered in these cases.

The risk of serious reactions in connection with use of VISIPAQUE is regarded as remote. However, iodinated contrast media may provoke anaphylactoid reactions or other manifestations of hypersensitivity. A course of action should therefore be planned in advance, with necessary drugs and equipment available for immediate treatment, should a serious reaction occur.

It is advisable always to use an indwelling cannula or catheter for quick intravenous access throughout the entire X-ray procedure. The possibility of hypersensitivity including serious, life-threatening, fatal anaphylactic/ anaphylactoid reactions should always be considered.

The majority of serious undesirable occur within the first 30 minutes. Late onset (that is 1 hour or more after application) hypersensitivity reactions can occur. Advanced life support facilities should be readily available. Patients should be observed for at least 30 minutes after administration of VISIPAQUE.

Patients using beta blockers may present with atypical symptoms of hypersensitivity which may be misinterpreted as a vagal reaction. The use of beta-adrenergic blocking agents may lower the threshold for bronchospasm in asthmatic patients after contrast medium administration, and reduce the responsiveness of treatment with adrenaline.

Coagulopathy:

Non-ionic, iodinated contrast media inhibit blood coagulation in vitro less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes containing contrast media including non-ionic media. The use of plastic syringes in place of glass syringes has been reported to decrease but not eliminate the likelihood of in vitro clotting.

Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angio-cardiographic procedures with both ionic and non-ionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events.

Numerous factors, including length of procedure, catheter and syringe material, underlying disease state, and concomitant medications, may contribute to the development of thromboembolic events. g. ) so as to minimize the risk of procedure-related thrombosis and embolism.

Care should be taken in patients with homocystinuria. (risk for thromboembolism). Hydration Adequate hydration should be assured before and after contrast media administration. This applies especially to patients with multiple myeloma, diabetes mellitus, renal dysfunction, as well as to infants, small children and elderly patients.

Young infants (age < 1 year) and especially neonates are susceptible to electrolyte disturbance and haemodynamic alterations. Cardio-circulatory reactions Care should also be taken in patients with serious cardiac disease and pulmonary hypertension as they may develop haemodynamic changes or arrhythmias.

Rarely severe life-threatening reactions and fatalities of cardiovascular origin such as cardiac-, cardio-respiratory arrest and myocardial infarction have occurred. 8). Contrast encephalopathy may manifest with symptoms and signs of neurological dysfunction such as headache, visual disturbance, cortical blindness, confusion, seizures, loss of coordination, hemiparesis, aphasia, unconsciousness, coma and cerebral oedema within minutes to hours after administration of iodixanol, and generally resolves within days.

The product should be used with caution in patients with conditions that disrupt the integrity of the blood brain barrier (BBB), potentially leading to increased permeability of contrast media across the BBB and increasing the risk of encephalopathy.

Patients with acute cerebral pathology, tumours or a history of epilepsy are predisposed for seizures and merit particular care. Also alcoholics and drug addicts have an increased risk for seizures and neurological reactions. In regard to intravascular application care should be taken in patients with acute stroke or acute intracranial bleeding, in patients with altered blood brain barrier, cerebral oedema or acute demyelinisation.

If contrast encephalopathy is suspected, administration of iodixanol should be discontinued and appropriate medical management should be initiated. Renal reactions Major risk factor for contrast medium-induced nephropathy is underlying renal dysfunction.

Diabetes mellitus and the volume of iodinated contrast medium administered are contributing factors in the presence of renal dysfunction. Additional concerns are dehydration, advanced arteriosclerosis, poor renal perfusion and the presence of other factors that may be nephrotoxic, such as certain medications or major surgery.

To prevent acute renal failure following contrast media administration, special care should be exercised in patients with pre-existing renal impairment and diabetes mellitus as they are at risk. Patients with paraproteinemias (myelomatosis and Waldenström’s macroglobulinemia) are also at risk.

Preventive measures include: - Identification of high risk patients - Ensuring adequate hydration. v. infusion from before the procedure until the contrast medium has been cleared by the kidneys. - Avoiding additional strain on the kidneys in […]

Hypersensitivity to the active substance or to any of the excipients. Manifest thyrotoxicosis.