Fluorescein Other names: Fluorescein sodium

There are no or limited data available concerning the use of fluorescein 100 mg/ml solution for injection in pregnancy. Animal studies do not indicate teratogenic effects. As a precautionary measure, it is preferable to avoid the use of fluorescein 100 mg/ml solution for Injection during pregnancy.

Fluorescein is excreted in human milk following systemic administration for up to 7 days. A risk to the suckling child cannot be excluded. Following fluorescein angiography, breast-feeding should therefore be discontinued for 7 days and the milk should be pumped off and discarded during this period.

Fertility

Studies have not been performed to evaluate the effect of intravenous administration of fluorescein on fertility.

If mydriasis is necessary for the examination with fluorescence angiography visual acuity is influenced and thus affects the ability to react in traffic or use machinery. The patient must be made aware that after application and until visual acuity returns to normal, driving a vehicle or operating dangerous machinery is prohibited.

Summary of safety profile

The most frequently reported treatment related undesirable effects were nausea, vomiting, syncope and pruritus. Less frequent but more severe adverse reactions have been reported shortly after fluorescein injection such as: angioedema, respiratory disorders (bronchospasm, laryngeal oedema, and respiratory failure), anaphylactic shock, hypotension, loss of consciousness, convulsion, respiratory arrest, and cardiac arrest.

List of adverse reactions

The following adverse reactions were assessed to be treatment-related and are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness.

Immune system disorders

Uncommon: hypersensitivity

Rare: anaphylactic reaction

Very rare: anaphylactic shock

Nervous system disorders

Common: syncope

Uncommon: dysphasia, paraesthesia, dizziness, headache

Very rare: convulsion

Not known: cerebrovascular accident, vertebrobasilar insufficiency, loss of consciousness, tremor, hypoaesthesia, dysgeusia,

Cardiac disorders

Rare: cardiac arrest

Very rare: angina pectoris, bradycardia, tachycardia

Not known: myocardial infarction,

Vascular disorders

Uncommon: thrombophlebitis

Rare: hypotension, shock

Very rare: hypertension, vasospasm, vasodilatation, pallor, hot flush

Respiratory, thoracic and mediastinal disorders

Uncommon: cough, throat tightness

Rare: bronchospasm

Very rare: respiratory arrest, pulmonary oedema, asthma, laryngeal oedema, dyspnoea, sneezing, nasal oedema

Not known: throat irritation

Gastrointestinal disorders

Very common: nausea

Common: abdominal discomfort, vomiting

Uncommon: abdominal pain

Not known: retching

Skin and subcutaneous tissue disorders

Common: pruritus

Uncommon: urticaria

Not known: rash, cold sweat, eczema, erythema, hyperhidrosis, skin discolouration

General disorders and administration site conditions

Common: extravasation

Uncommon: pain, feeling hot

Not known: chest pain, oedema, malaise, asthenia, chills

Description of selected adverse reactions

A yellowish discolouration of the skin could appear but usually disappears within 6 to 12 hours. Urine, which may also exhibit a bright yellow colouration, returns to its normal colour after 24 to 36 hours.