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 the 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 the available data).
List summarising the undesirable effects reported with TELEBRIX 30 Meglumine 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*
Psychiatric disorders         Unknown frequency: confusional state, agitation Nervous system                Unknown frequency: coma, syncope, convulsion, paresis/paralysis, disorders                     paresthesiae, tremor, dizziness, headache Cardiac disorders             Unknown frequency: cardiac arrest, myocardial infarction, angina pectoris, arrhythmia, tachycardia
Vascular disorders            Unknown frequency: hypotension, thrombophlebitis, circulatory collapse
Respiratory, thoracic and     Unknown frequency: respiratory arrest, laryngeal œdema, mediastinal disorders         laryngospasm, pulmonary œdema, bronchospasm, throat tightness, cough
Gastrointestinal              Unknown frequency: diarrhoea, nausea, vomiting, abdominal pain disorders
Skin and subcutaneous         Unknown frequency: tissue disorders              Immediate: angiœdema, urticaria, pruritus, erythema Delayed:rash maculo-papular
Renal and urinary             Unknown frequency: renal failure acute, anuria disorders
General disorders and         Unknown frequency: œdema, face oedema, pain, feeling hot, malaise, administration site           injection site extravasation, injection site pain, injection site conditions                    inflammation, injection site oedema, injection site necrosis1 Investigations                Unknown frequency: Blood creatinine increased 1 in the event of extravasation
* 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                        Hallucinations, anxiety
Nervous system disorders                    Brain œdema, amnesia, speech disorder, somnolence, dysgeusia
Eye disorders                               Visual impairment, photophobia, blindness transient Ear and labyrinth disorders                 Hearing impaired

Cardiac disorders                           Bradycardia
Respiratory, thoracic and mediastinal
Pneumonia aspiration1, sneezing disorders
Gastrointestinal disorders
Pancreatitis2, ileus3, parotid gland           enlargement,
System Organ Class                                  Undesirable effect salivary hypersecretion
Reproductive system and breast
Pelvic pain4 disorders
Skin and subcutaneous tissue disorders         Stevens-Johnson      syndrome,     toxic      epidermal necrolysis, erythema multiforme, eczema
Musculoskeletal and connective tissue          Arthralgia5 disorders
Investigations                                 Electroencephalogram      abnormal,   blood    amylase increased
1 in patients with swallowing disorders (oral route)
2 after endoscopic retrograde cholangio-pancreatography (ERCP)
3 after enteral administration
4 in the event of hysterosalpingography
5 in the event of arthrography

Undesirable effects in children
The known nature of undesirable effects associated with TELEBRIX 30 Meglumine is the same as that of effects reported in adults. Their frequency cannot be estimated from available data.