Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Below are listed possible side effects in relation with radiographic procedures which include the use of VISIPAQUE.

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, cardiorespiratory 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.
Rare: Pain, discomfort, shivering (chills), pyrexia, administration site reactions including extravasation
Very rare: Feeling cold, asthenic conditions (e.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

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/ and emailed to the Registration Holder’s Patient Safety Unit at: drugsafety@neopharmgroup.com