100 mg / ml injection solution
fluorescein
What Fluorescite 100 mg/ml solution for injection is and what it is used for
Fluorescite 100 mg/ml solution for injection is a solution of a dye that makes the blood vessels in the back of the eye visible during an eye examination (this procedure is called fluorescein angiography ). The drug is for diagnostic use only. It is not used to treat any disease.
What you need to know before you are given Fluorescite 100 mg/ml solution for injection
You should NOT be given Fluorescite 100 mg/ml solution for injection
- if you are allergic (hypersensitive) to fluorescein or any of the other ingredients of this medicine (listed in section 6). Tell your doctor if you think you are allergic or hypersensitive to fluorescein or any of the other ingredients of Fluorescite 100 mg/ml solution for injection.
Warnings and cautions
Talk to your doctor before giving Fluorescite 100 mg/ml solution for injection
- if you have any other illness, e.g. cardiovascular disease or diabetes ( diabetes mellitus )
- if you have impaired kidney function. Then your doctor may normally give you a lower dose of Fluorescite 100 mg/ml solution for injection.
- if you are taking beta-blocker medicines. Beta-blockers are used to treat high blood pressure and certain heart diseases and are also used as eye drops for the treatment of glaucoma ( glaucoma ). An allergic reaction to Fluorescite 100 mg/ml solution for injection may cause a rapid drop in blood pressure. Blood pressure may be lower in patients treated with beta-blockers (eg atenolol, sotalol, propranolol, metoprolol, bisoprolol).
- if you have reacted to fluorescein before. You may need to get another medicine to reduce nausea.
- if you are on a low sodium diet. Fluorescite 100 mg / ml solution for injection contains up to 3.15 mmol (72.45 mg) sodium per dose .
If any of the above apply to you or you are not sure, tell your doctor before giving Fluorescite 100 mg/ml solution for injection.
Other medicines and Fluorescite 100 mg/ml solution for injection
Tell your doctor if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. This medicine must not be used with other medicines.
Pregnancy, breastfeeding, and fertility
Pregnancy and fertility
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. If you are pregnant, Fluorescite 100 mg/ml solution for injection should only be used after your doctor has prescribed it. Due to limited experience with this medicine, the use of Fluorescite 100 mg/ml solution for injection should be used with caution during pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding. Fluorescein, the active substance in Fluorescite 100 mg/ml solution for injection, passes into breast milk and is slowly excreted therefrom. Therefore, you should not breast-feed for 7 days after administration of Fluorescite 100 mg/ml solution for injection. During these days, breast milk should be pumped out and discarded.
Driving and using machines
As part of your eye examination, you may be given eye drops that dilate the pupil. This can temporarily affect your vision and your ability to drive and use machines. Do not drive or use any tools or machines until your vision has returned to normal.
Important information about some of the ingredients of Fluorescite
This medicine contains up to 3.15 mmol (72.45 mg) sodium per dose This should be considered by patients on a low-salt diet.
How to give Fluorescite 100 mg/ml solution for injection
Fluorescite 100 mg/ml solution for injection is given by your doctor. Depending on your condition, the dose may need to be adjusted. As this is a product that has not been studied in children, there is no information on the appropriate dose for children. Fluorescite 100 mg/ml solution for injection should therefore not be used in patients below 18 years of age as efficacy and safety have not been established in this group.
Injection
A bottle of Fluorescite 100 mg/ml solution for injection is usually given into a vein in the arm. Fluorescite 100 mg/ml solution for injection should not be injected intrathecally (into the spinal canal) or intraarterially (into arteries ).
If you have any further questions on the use of Fluorescite 100 mg/ml solution for injection, contact your doctor.
4. Possible side effects
Like all medicines, Fluorescite 100 mg/ml solution for injection can cause side effects, although not everybody gets them. The following side effects have been reported:
Very common side effects are
May affect more than 1 user in 10
Nausea.
Common side effects are
May affect up to 1 in 10 users
Vomiting, stomach problems, fainting, itching, fluid, or blood leaks from the vein.
Uncommon side effects are
May affect up to 1 in 100 users
Headache, dizziness, tingling in the skin, cough, feeling of a tight throat, abdominal pain, rash, impaired speech, pain, feeling hot, hypersensitivity, inflammation of the veins.
Rare side effects are
May affect up to 1 in 1,000 users
Severe allergic reaction, cardiac arrest, low blood pressure, shock, breathing problems, or wheezing ( bronchospasm ).
Very rare side effect s
May affect up to 1 in 10,000 users
Anaphylactic shock, seizures, angina pectoris, low heart rate, fast heart rate, high blood pressure, vascular spasm, calf muscle spasms, poor circulation, reddening of the skin, pallor, hot flashes, respiratory arrest, fluid in the lungs, asthma, impaired respiratory function, swelling, swelling, swelling, sneezing.
Has been reported
Occurs in an unknown number of users
Stroke, chest pain, unconsciousness, tremors, abnormal or decreased sensitivity of the skin, rash, cold sweats, dermatitis, sweating, edema (swelling), general weakness, heart attack, throat irritation, skin discoloration, abnormal taste sensation, and chills.
After administration of Fluorescite 100 mg/ml solution for injection, you may experience a change in taste. Your skin may turn yellow; this color usually disappears after 6-12 hours. Your urine may also turn bright yellow; it may take 24-36 hours before the color returns to normal.
After injection, inflammation of the vein and blood clots in the vein may occur. If the solution leaks from the vein during injection, the skin may be damaged and the vein, nerves, and tissue near the injection site may become inflamed. This can lead to severe pain. If you experience pain or other problems at the injection site, contact your doctor. You may need to get painkillers or other treatment to alleviate the problems.
As mentioned earlier, fluorescein can cause unexpected serious side effects. They occur more often if you have had similar reactions to fluorescein before or if you suffer from allergies (caused by food or medicine), eczema, asthma, or hay fever.
If you experience any of the side effects are, or if you notice adverse effects not listed in this leaflet, contact your doctor.
Blood and urine tests
Fluorescein may affect some blood and urine tests for 3-4 days after you receive it. If you are going to have blood or urine tests or further x-rays during this period, tell your doctor that you have been given fluorescein.
5. How to store Fluorescite 100 mg/ml solution for injection
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the label and carton (EXP). The expiration date is the last day of the specified month.
- A vial should be used immediately after opening.
- Your doctor or nurse knows how to store Fluorescite 100 mg/ml solution for injection.
- Do not store above 25 ° C. Do not freeze. Keep the vial in the outer carton. Sensitive to light.
- Do not use Fluorescite 100 mg/ml solution for injection if the vial is cracked or damaged in any way.
- The solution should be inspected to see if it contains particles or discoloration before use. The solution may only be used if it is clear and free of particles.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is fluorescein.
1 ml solution contains 100 mg fluorescein (as 113.2 mg fluorescein sodium).
One vial of 5 ml solution contains 500 mg fluorescein (as 566 mg fluorescein sodium).
The other ingredients are sodium hydroxide and/or hydrochloric acid (to adjust the acidity) and water for injections.
What the medicine looks like and the contents of the pack
Fluorescite 100 mg/ml solution for injection is a clear red-orange solution for injection.
Fluorescite 100 mg/ml solution for injection is supplied in packs of 12 vials of 5 ml solution for injection.
Marketing Authorisation Holder
Alcon Nordic A / S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark
Manufacturer
SA Alcon-Couvreur NV
Rijksweg 14
2870 Puurs
Belgium
This medicinal product is authorized under the European Economic Area under the names:
| Name of Member State | Name of the medicine |
|---|---|
| The Czech Republic | Fluorescite 100mg / ml injectable drug |
| Denmark | Anantara 100 mg / ml solution for injection |
| Estonia | Fluorescite 100 mg / ml solution for injection |
| Finland | Fluorescite 100 mg / ml solution for injection |
| Germany | Fluorescein Alcon 10% |
| Iceland | Anatera 100 mg / ml solution for injection |
| Latvia | Fluorescite 100 mg / ml solution for injection |
| Lithuania | Fluorescite 100 mg / ml solution for injection |
| Netherlands | Fluorescite 100mg / ml solution for injection |
| Norway | Anatera 100 mg / ml solution for injection |
| Poland | Fluorescite |
| Slovakia | Fluorescite |
| UK | Anatera 100mg / ml solution for injection |