Fluorescein SERB 500 mg/5 mL Solution for injection
Fluorescein SERB 500 mg/5 mL Solution for injection is in the diagnostic preparations (other) subcategory of medical tests.
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Consumer medicine information leaflet (CMI)
Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Fluorescein Novartis 500mg/5mL.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available.
You should ensure that you speak to your pharmacist or doctor to obtain the most up-to-date information on the medicine. You can also download the most up-to-date leaflet from www.novartis.com.au. Those updates may contain important information about the medicine and its use of which you should be aware.
All medicines have risks and benefits. Your doctor has weighed the risks of you using Fluorescein Novartis 500mg/5mL against the benefits they expect it will have for you.
If you have any concerns about using this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What Fluorescein Novartis 500mg/5mL is used for
This medicine is used to look at the blood moving through the blood vessels at the back of your eye(s) so your doctor can identify any areas of your eye(s) which may be damaged or unhealthy.
It is known as a diagnostic agent.
It works by fluorescing when stimulated by blue light.
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.
This medicine is not addictive.
It is available only with a doctor's prescription.
Before you are given Fluorescein Novartis 500mg/5mL
When you must not be given it
Do not use Fluorescein Novartis 500mg/5mL if you have an allergy to:
- any medicine containing fluorescein sodium
- any of the ingredients listed at the end of this leaflet
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.
If you are not sure whether you should start using this medicine, talk to your doctor.
Before you are given it
Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.
Tell your doctor if you have or have had any of the following:
- a history of bronchial asthma or allergy (e.g. hay fever)
- a history of heart or lung disease (e.g. asthma)
- a reaction to any medicine used in a previous diagnostic examination.
Tell your doctor if you are currently taking beta-blockers, medicines used to treat high blood pressure, heart conditions or migraine, including beta-blocker eye drops use to treat glaucoma.
Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Your doctor can discuss with you the risks and benefits involved. This medicine passes into breast milk and therefore there is a possibility that a breastfed baby may be affected.
If you have not told your doctor about any of these things, tell him/her before you start using Fluorescein Novartis 500mg/5mL.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including medicines that you get without a prescription from a pharmacy, supermarket or health food shop. Some medicines and Fluorescein Novartis 500mg/5mL may interfere with each other. These include beta-blockers, medicines used to treat high blood pressure, heart conditions or migraine, including beta-blocker eye drops use to treat glaucoma.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.
How Fluorescein Novartis 500mg/5mL is given
Your doctor will prepare and administer Fluorescein Novartis 500mg/5mL for you.
Follow the directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor for help.
How much is given
The usual dose of Fluorescein Novartis 500mg/5mL is one ampoule of 5mL. Children may receive smaller amounts, depending on their weight.
How it is given
Fluorescein Novartis 500mg/5mL is injected into a vein, usually in your arm.
While you are being given Fluorescein Novartis 500mg/5mL
Things you must do
Stay in your doctor's rooms for at least 30 minutes after the injection so you can be watched for a possible allergic reaction. Serious, acute allergic reactions, including anaphylactic shock which can be life-threatening, have been rarely observed in patients receiving Fluorescein Novartis 500mg/5mL.
Tell a doctor or a nurse straight away if you experience symptoms suggestive of an allergic reaction, such as 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.
Tell your doctor if you notice any pain, swelling, or redness at the injection site. If the injection solution leaks from the vein, it may cause damage to the skin or inflammation of veins and tissues close to the injection site.
Things to be careful of
Do not drive or operate machinery if your vision is affected by this procedure. Fluorescein Novartis 500mg/5mL does not affect vision but other drugs used during the procedure may cause blurred vision.
If your vision is blurred, do not drive, operate machinery or do anything else that could be dangerous. Children should be careful when riding bicycles or climbing trees.
If you are about to have any blood or urine tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.
You may notice a yellow discolouration of your skin and a bright yellow colouring of your urine after you are given this medicine. This effect is temporary.
This medicine can stain skin, clothing and soft contact lenses on contact.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being treated with Fluorescein Novartis 500mg/5mL. This medicine may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
- skin discolouration or bright yellow urine lasting longer than expected.
- headache, dizziness, fainting, tingling or numbness
- nausea, vomiting or abdominal pain
- cough, sneezing, tightness in the throat or difficulty in swallowing
- change in your sense of taste
- chills or hot flushes, feeling unwell
- pain at the injection site.
The above list includes the more common side effects of your medicine. They are usually mild and short-lived.
Tell your doctor as soon as possible if you notice any of the following:
- skin reactions such as flushing, itching or skin rash
- shortness of breath
- chest pain, changes in heart rate
- severe shock and/or convulsions.
The above list includes serious side effects which may require medical attention.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:
- symptoms of an allergic reaction such as chest pain or tightness, wheezing, difficulty breathing, fever, rashes and hives, swelling of the face, neck and throat, fainting. Serious allergic reactions, including anaphylactic shock which can be life-threatening, have been reported in patients given Fluorescein Novartis 500mg/5mL.
- intense pain at the injection site, swelling and redness along a vein which is extremely tender when touched. These are symptoms of reactions at the injection site, which can result in tissue damage.
Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.
After using Fluorescein Novartis 500mg/5mL
You will not need to store Fluorescein Novartis 500mg/5mL. Your doctor will obtain and keep it for you.
What it looks like
Fluorescein Novartis 500mg/5mL comes as a clear, orange-yellow solution with a yellowish green fluorescence in a 5mL ampoule.
Fluorescein Novartis 500mg/5mL contains 100 mg/mL of fluorescein sodium as the active ingredient. It also contains:
- sodium hydroxide (to adjust pH)
- water for injections.
This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
Fluorescein Novartis 500mg/5mL is supplied in Australia by:
Novartis Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
North Ryde NSW 2113
Web site: www.novartis.com.au
Date of preparation
This leaflet was prepared in January 2012.
AUST R 124565