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10 X 5 ml
Adults: One single dose of 500 mg (1 ampoule of 5 mL).
Renal impairment: Limited experience in patients with renal impairment suggests that no dose adjustment is necessary in patients with renal impairment.
Hepatic impairment: No studies have been performed in patients with hepatic impairment. There is no information to suggest that dosage adjustment is necessary in patients with hepatic impairment.
Pediatrics: Studies in the pediatric population have not been performed. If Fluoresceine Novartis is used in children a dosage adjustment is recommended, e.g., 5 mg/kg.
Geriatrics (65 years old and over): There is no indication that dosage needs to be modified for the elderly.
Method of administration: Fluoresceine Novartis is given by intravenous (IV) injection.
For examination of the retina by fluorescent angiography
Known hypersensitivity to the active substance or to any of the excipients.
Intrathecal or intra-arterial use.
Before administration a complete medical history must be obtained, including history of allergy, history of cardio-pulmonary disease, concomitant medication (in particular beta-blockers, including eye drops). Caution is to be exerted in patients with a history of allergy or bronchial asthma.
Hypersensitivity reactions: Hypersensitivity reactions, including rare cases of anaphylactic/anaphylactoid shock (some with fatal outcome), have been reported in patients receiving Fluoresceine Novartis. If serious hypersensitivity reactions have occurred during previous angiography with other diagnostic agents or there is a history of severe allergic reactions, the need for fluorescein angiography must be very carefully considered and the diagnostic importance balanced against the risk of a severe, possibly fatal (rate 1 in 220,000 angiographies as collected in a survey), allergic reaction.
– Managing risk of hypersensitivity reaction with fluorescein angiography requires: The patient must be kept under close observation for at least 30 minutes after angiography.
– An emergency tray with appropriate resuscitation equipment including the drugs used to treat hypersensitivity reactions such as e.g., epinephrine, fluids for i.v. volume substitution, oxygen and corticosteroids, should always be available.
Cardiovascular disease: Severe cardiovascular complications such as chest pain, myocardial infarction and shock have occurred following administration of fluorescein sodium. Before undergoing an elective procedure with fluorescein sodium, patients with a history of cardiovascular disease require careful evaluation.
Combination with beta-blockers: Combination with beta-blockers may in rare cases cause lethal anaphylactic reactions. In patients identified as being at risk of hypersensitivity reactions, but in whom a fluorescein angiography is considered to be essential, the procedure must be carried out in the presence of a specialist in resuscitation, particularly when the patient is under beta-blocker therapy, including beta-blocker eye drops, as they may require more intensive resuscitation measures due to reduced efficacy of epinephrine and volume expansion.
Extravasation: Care must be taken to avoid extravasation during injection. The high pH of the fluorescein solution can result in severe local tissue damage. Complications from extravasation can cause severe pain,
thrombophlebitis and an inflammatory reaction of the tissue leading to tissue necrosis. Before fluorescein is administered, precautions to avoid extravasation must be taken and the correct intravenous position of the needle tip must be ascertained. In case extravasation occurs, the injection must be stopped immediately and appropriate measures must be taken to treat damaged tissue and to relieve pain.
Laboratory tests: The fluorescence may interfere with the analysis of blood and urinary parameters for a period of 3 to 4 days. Interference of fluorescein with serum concentration determination of digoxin and cortisol has been reported. Caution is advised when performing therapeutic drug monitoring for drugs with a narrow therapeutic window.
Incompatibility: Concomitant intravenous injection of other solutions or the mixing of Fluoresceine Novartis with other solutions or agents should be avoided since the possibility of physico-chemical incompatibilities cannot be excluded.
Driving and using machines: No effects of Fluoresceine Novartis that would adversely influence the ability to drive are known. However, the mydriasis and cycloplegia required for the fluorescein angiography examination may affect vision. Patients should be advised that this might impair their ability to drive or to operate machinery.
For full details see prescribing information.
The occurrence of the following adverse reactions has been reported with use of fluorescein sodium injection 10% in clinical trials. A summary of treatment-emergent adverse events and their estimate of frequencies (very common, common, uncommon, rare, very rare) in accordance with preferred term and system organ class (SOC) of any severity are listed below: Very common (≥ 10%) Common (≥ 1% to < 10%) Uncommon (≥ 0.1% to < 1%) Rare (≥ 0.01% to < 0.1%) Very rare (< 0.01% )
Gastrointestinal disorders: Very common: nausea Common: vomiting Uncommon: abdominal pain.
General disorders and administration site conditions: Common: extravasation Uncommon: dysphasia, feeling hot, pain.
Nervous system disorders: Common: syncope Uncommon: dizziness, paresthesia.
Respiratory, thoracic and mediastinal disorders: Uncommon: cough, throat tightness.
Skin and subcutaneous tissue disorders: Uncommon: urticaria.
Post-marketing experience: 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 respiratory disorders (bronchospasm, laryngeal oedema), anaphylactic/anaphylactoid shock (with fatal outcome), hypotension, loss of consciousness, convulsion, respiratory and cardiac arrest.
Additionally, a yellowish discoloration of the skin could appear but usually disappears within 6 to 12 hours. Urine, which may also exhibit a bright yellow coloration, returns to its normal color after 24 to 36 hours. A summary of treatment-emergent adverse events and their estimate of frequencies (very common, common, uncommon, rare, very rare) in accordance with preferred term and system organ class (SOC) of any severity as indicated above:
Cardiac disorders: Rare: cardiac arrest Very rare: angina pectoris, bradycardia and tachycardia Not known: acute myocardial infarction, shock.
General disorders and administration site conditions: Common: extravasation Uncommon: pain, feeling hot Very rare: death Not known: oedema, malaise, asthenia, chills, chest pain.
Immune system disorders: Uncommon: hypersensitivity Rare: anaphylactic reaction Very rare: anaphylactic shock, anaphylactoid reaction, anaphylactoid shock.
Nervous system disorders: Common: dysgeusia, syncope Uncommon: headache, paraesthesia, dizziness Very rare: convulsions Not known: vertebrobasilar insufficiency, loss of consciousness, tremor, hypoaesthesia, cerebrovascular accident.
Respiratory, thoracic and mediastinal disorders: Uncommon: cough, throat tightness Rare: bronchospasm Very rare: dyspnoea, sneezing, pulmonary oedema, asthma, respiratory arrest, hypoventilation, laryngeal oedema, nasal oedema.
Skin and subcutaneous tissue disorders: Common: urticaria, pruritus. Not known: rash, cold sweat, eczema, erythema, hyperhidrosis, dermatitis.
Vascular disorders: Uncommon: thrombophlebitis Rare: shock, hypotension Very rare: vasodilatation, hypertension, pallor, hot flush, peripheral vascular disorder, intermittent claudication, vasospasm.
Gastrointestinal disorders: Very common: nausea Common: abdominal discomfort, vomiting Uncommon: abdominal pain Not known: retching. Fluorescein sodium can stain skin, clothing and soft contact lenses on contact.
Beta-blockers: Due to an interference of beta-blockers at the level of the beta-receptors, anaphylactic/anaphylactoid reactions may be more severe.
Organic anion transporter inhibitors: Compounds that inhibit the active transport of organic anions (e.g., probenecid) may affect the systemic profile of fluorescein.
Laboratory tests: The fluorescence may interfere with the analysis of blood and urinary parameters for a period of 3 to 4 days.
Systemic concentration of fluorescein had been reported to interfere in the determination of digoxin and cortisol in serum when fluorescence polarization immunoassay-based analysers are used. Caution is advised when performing therapeutic drug monitoring for drugs with a narrow therapeutic window, e.g., digoxin, quinidine.
Pregnancy and Lactation
Women of child-bearing potential: No specific recommendation for women of child-bearing potential. For information regarding the use of Fluoresceine Novartis during pregnancy please refer to the next section.
Pregnancy: Insufficient data are available on the use of fluorescein in pregnant women. Animal studies do not indicate teratogenic effects. The potential risk for human fetus during pregnancy is unknown. Avoid the use of Fluoresceine Novartis in patients who are pregnant unless considered absolutely necessary.
Breast-feeding: Fluorescein is excreted in human milk and could be measured after 3 to 4 days following intravenous administration. Breast-feeding should be discontinued for 4 days following fluorescein angiography. Based on the available data, extrapolation on excretion of fluorescein in breast milk suggests a complete removal of fluorescein may take approximately 2 weeks after intravenous administration.
Fertility: There is no fertility data available.