FLUORESCEINE SERB

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FLUORESCEIN SODIUM

Available from:

TRADIS GAT LTD

ATC code:

S01JA01

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

FLUORESCEIN SODIUM 10 G / 100 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

SERB SAS, FRANCE

Therapeutic area:

FLUORESCEIN

Therapeutic indications:

For examination of the retina by Fluorescent Angiography.

Authorization date:

2016-02-02

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fluoresceine SERB
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluorescein sodium 10g/100 ml of solution for injection.
One 5 mL ampoule contains 0.5g of fluorescein sodium.
One 5 mL ampoule contains 65.5 mg of sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
For examination of the retina by fluorescent angiography.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
One 5-ml ampoule (10%) injected intravenously.
PATIENTS WITH RENAL IMPAIRMENT
The limited experience with use of Fluorescein sodium in patients with
renal impairment suggests that
dose adjustment in these patients is not necessary required (see
section 5.2).
PATIENTS WITH HEPATIC IMPAIRMENT
No studies have been performed in patients with hepatic Impairment.
PAEDIATRIC POPULATION
The safety
and the efficacy
of Fluorescein SERB in children
and adolescents below 18 years have
not been
established.
Therefore,
Fluorescein SERB
should not be used.
GERIATRICS (65 YEARS OLD AND OVER)
Experience in geriatric patients suggests that no dose adjustment is
necessary.
METHOD OF ADMINISTRATION
Intravenous use.
Fluorescein SERB
should not be mixed with other medicinal products (see section 6.2 and
section 6.6) and
should preferably be injected into the antecubital vein after taking
precautions to avoid extravasation (see section
4.4).
4.3. CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Use by intrathecal or arterial routes.
2
4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
A detailed medical history of each patient must be carried out before
examination including any history
of allergy, history of cardiopulmonary disease, diabetes mellitus or
concomitant treatments (in particular
beta-blocking drugs, including eye drops solutions). Beta-blocking
agents can reduce the vascular
compensation reactions and reduce the effectiveness of a