देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
fluorescein sodium, Quantity: 250 mg/mL
Phebra Pty Ltd
Injection, intravenous infusion
Excipient Ingredients: sodium hydroxide; water for injections; hydrochloric acid
Intravenous
5mL x 10
(S4) Prescription Only Medicine
INDICATIONS AS AT 01 JANUARY 1991 : Diagnostic - Intravenous injection of sodium fluorescein dye followed by multiframe photography (angiography) or ophthalmoscopic evaluation (angioscopy). Used in evaluation of wide range of retinal and choroidal diseases. Less commonly used to evaluate abnormalities of the optic nerve and iris. May be used in diagnosis and management of macular and vascular (including diabetes) diseases.
Visual Identification: Clear red solution becoming fluorescent on dilution; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1991-10-14
Retinofluor 10% and 25% Page 1 of 3 _Version 08 _ RETINOFLUOR™ FLUORESCEIN SODIUM INJECTION 10% AND 25% CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Retinofluor. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits . Your doctor has weighed the risks of you being given Retinofluor against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR. KEEP THIS LEAFLET IN A SAFE PLACE. You may need to read it again. WHAT RETINOFLUOR IS USED FOR Retinofluor is used to highlight blood vessels in the back of the eye so that a special camera can be used to take pictures and analyze the blood circulation in the eye. This helps doctors diagnose any problems or diseases of the eye._ _ This medicine belongs to a group of medicines called synthetic dyes. Retinofluor is an orange to red coloured fluorescent dye. This medicine works by making the blood vessels in the eye fluoresce for a short time so that these vessels can be more easily seen in a photograph. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. BEFORE YOU ARE GIVEN RETINOFLUOR _WHEN YOU MUST NOT BE GIVEN _ _IT_ _ _ YOU SHOULD NOT BE GIVEN RETINOFLUOR IF YOU HAVE AN ALLERGY TO: • any medicine containing fluorescein sodium • any of the ingredients listed at the end of this leaflet • any other similar medicines such as synthetic dyes. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin._ _ YOU SHOULD NOT BE GIVEN THIS MEDICINE IF YOU ARE PREGNANT. It may affect your developing baby if you are given it during pregnancy. DO NOT BREAST-FEED IF YOU ARE BEING GIVEN THIS MEDICINE. The active पूरा दस्तावेज़ पढ़ें
PRODUCT INFORMATION Australian Product Information – Retinofluor (Fluorescein Sodium Injection) Page 1 of 7 Version 13 RETINOFLUOR™ INJECTION (FLUORESCEIN SODIUM) 1 NAME OF THE MEDICINE Fluorescein sodium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Fluorescein sodium 10% injection contains 100 mg in 1 mL (available in 5 and 10 mL vials) and fluorescein sodium 25% injection contains 250 mg in 1 mL (5 mL vials) in water for injection. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Retinofluor is an orange/red sterile solution for intravenous administration. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Diagnostic: Intravenous injection of fluorescein sodium dye followed by multiframe photography (angiography) or ophthalmoscopic evaluation (angioscopy). It is used in evaluation of a wide range of retinal and choroidal diseases. It is less commonly used to evaluate abnormalities of the optic nerve and iris. It may be used in diagnosis and management of macular and vascular (including diabetic) diseases. 4.2 D OSE AND METHOD OF ADMINISTRATION Product is for single use in one patient only. Discard any residue. After taking precautions to avoid extravasation (e.g. checking with the lights on) 10% or 25% fluorescein sodium injection is rapidly injected in the antecubital vein and then the room lights turned off. A recommended dose is 500 mg but this dose may be varied depending on the patient and the camera used in the diagnostic procedure and the individual experience of the operator. It is recommended that the dose be kept as low as possible. About ten minutes after the injection, very little of the fluorescein sodium dye remains in the eye. The retina and choroidal vessels are stained within 15 seconds and the optic disc will normally fluoresce for several hours after injection. 4.3 C ONTRAINDICATIONS Sensitivity to fluorescein sodium or any components in the injection. Concomitant use of contact lenses. PRODUCT INFORMATION RETINOFLUOR ™ Australian Product Informa पूरा दस्तावेज़ पढ़ें