Adverse reactions : תופעות לוואי

4.8.      Undesirable effects
Since marketing, the most frequently reported undesirable effects after administration of all forms of TELEBRIX are: hypersensitivity (particularly anaphylactic reaction, anaphylactoid reaction and anaphylactic shock), urticaria, rash (particularly erythema and maculopapular rash) and reactions at injection site (such as oedema, pain and inflammation).
Hypersensitivity reactions are usually immediate (occurring during administration or within the hour following the start of administration), but they may be delayed (from one hour to several days after administration), and are seen as undesirable cutaneous reactions.
Immediate reactions may consist in one or several successive or concomitant effects, usually cutaneous reactions, respiratory and/or cardiovascular disorders, which may be the early signs of shock. They are rarely fatal.
The undesirable effects are presented in the table below according to System Organ Class; frequency is unknown (cannot be estimated from available data).
List summarising the undesirable effects reported with TELEBRIX GASTRO or another form of TELEBRIX after intravascular administration or instillation:


System Organ Class           Frequency: undesirable effect
Immune system disorders      Unknown frequency: anaphylactic shock, anaphylactic reaction, anaphylactoid reaction, hypersensitivity
Endocrine disorders          Unknown frequency: thyrotoxic crisis *, hyperthyroidism*, thyroid disorder*
Nervous system               Unknown frequency: dizziness disorders
Cardiac disorders            Unknown frequency: cardiac arrest, tachycardia Vascular disorders           Unknown frequency: hypotension
Respiratory, thoracic and    Unknown frequency: laryngeal œdema, pneumonia aspiration1, mediastinal disorders        dyspnoea, sneezing
Gastrointestinal disorders   Unknown frequency: ileus, diarrhoea, nausea, vomiting, abdominal pain
Skin and subcutaneous        Unknown frequency: tissue disorders             Immediate: angiœdema, urticaria, pruritus, erythema Delayed: rash maculo-papular
General disorders and        Unknown frequency: face œdema administration site conditions
Investigations               Unknown frequency: Blood creatinine increased 1 in patients with swallowing disorders (oral route)
* See section 4.4.1.2. Iodinated contrast media and the thyroid

The following undesirable effects have been reported with other iodinated contrast media or with TELEBRIX via a different route of administration.
Hence, they may occur during administration of TELEBRIX.
System Organ Class                                 Undesirable effect Psychiatric disorders                       Confusional state, agitation, hallucinations, anxiety Nervous system disorders                    Coma,      syncope,     brain     œdema,   convulsion, paresis/paralysis paresthesiae, tremor, amnesia, speech disorders, somnolence, headache, dysgeusia
Eye disorders                               Visual impairment, photophobia, blindness transient Ear and labyrinth disorders                 Hearing impaired

Cardiac disorders                           Myocardial infarction, angina pectoris, arrhythmia, bradycardia
Vascular disorders
Thrombophlebitis1, circulatory collapse
Respiratory, thoracic and mediastinal
Respiratory arrest, laryngospasm, bronchospasm,
disorders pulmonary oedema, throat tightness, cough
Gastrointestinal disorders
Parotid gland enlargement, salivary hypersecretion,
pancreatitis2
Reproductive system and breast
Pelvic pain3 disorders
Skin and subcutaneous tissue disorders      Angioedema, urticaria, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, eczema
Musculoskeletal and connective tissue       Arthralgia4 disorders
Renal and urinary disorders                 Renal failure acute, anuria General disorders and administration site Oedema, feeling hot, pain, malaise, injection site conditions                                extravasation, injection site necrosis5, injection site pain, injection site inflammation, injection site oedema
Investigations                              Electroencephalogram      abnormal,     blood   amylase increased
1 after intravascular administration
2 after endoscopic retrograde cholangio-pancreatography (ERCP)
3 in the event of hysterosalpingography
4 in the event of arthrography
5 in the event of extravasation
Undesirable effects in children
The known nature of undesirable effects associated with TELEBRIX GASTRO is the same as that of effects reported in adults. Their frequency cannot be estimated from available data.