What about Fluorescein sodium injection. 10% (Solution for injection)
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Fluorescein Sodium Injection

Read all of this leaflet carefully before you start using this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you and should not be given to others, even if they have same symptoms, as it may harm them.

WHAT IS 10% FLUORESCENCE, INJECTABLE SOLUTION AND WHAT IT IS USED FOR

Fluorescein Ampule 10% is an injectable solution for intravenous administration.

Fluorescein Ampule 10% is a dye that is used as a contrast medium to visualize the blood vessels of the fundus and iris, using a diagnostic technique called fluorescence angiography.

This medicine is for diagnostic use only. It belongs to the group of medicines called "Agents for self-diagnosis: coloring".

BEFORE USE FLUORESCEIN SODIUM INJECTION 10%, INJECTABLE SOLUTION

Prior to administration of Fluorescein sodium injection 10%, your doctor may obtain your complete medical history, including information about the medication you are using.

If you have been given fluorescein or another agent for diagnostic use before and you have had severe intolerance reactions, your doctor should evaluate the suitability of using it again.

Do not use Fluorescein sodium injection 10%

- If you are allergic (hypersensitive) to fluorescein or any of the other ingredients of Fluorescein Ampule 10%.

- if you are taking beta-blockers, including beta-blockers in the form of eye drops, since co-administration with 10% Fluorescein Ampule may rarely lead to anaphylactic reactions (allergic reactions of a general and violent nature) For your life.

- This medicine should not be given intrathecally or intra-arterial.

Take special care with fluorescein sodium injection 10%

- If you have or have had bronchial asthma or any allergy, in which case you should tell your doctor as Fluorescein Ampule 10% can cause serious intolerance reactions.

- If you have had previous angiography and as a result have had reactions intolerance, or if you have had severe allergic reactions before, you should tell your doctor. In these cases, your doctor will evaluate the importance of the diagnosis against the risk of a possible serious allergic reaction.

- Should you need to have blood or urine tests, you should advise your doctor, since fluorescein sodium has the property of producing fluorescence, which can interfere with blood and urine analytical parameters.

If you have any of the conditions described above, notify your doctor before using Fluorescein Ampule 10%.

Use of other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

If you are receiving simultaneous treatment with beta-blockers, including beta-blockers in the form of eye drops, tell your doctor (see section 2. BEFORE YOU USE FLUORESCENCE, 10%, INJECTABLE SOLUTION).

Pregnancy

Consult your doctor or pharmacist before using a medication if you are pregnant or think you may be pregnant.

If you are pregnant you should not use Fluorescein Ampule 10%, unless your doctor considers it strictly necessary.

Lactation

Consult your doctor or pharmacist before using a medication if you are breastfeeding your child. In that case, you should stop breastfeeding for two days after fluorescence angiography, as fluorescein is excreted in breast milk.

Driving and using machines

Fluorescein Ampule 10% is not known to have any effect on driving ability. However, for the accomplishment of the fluorescence angiography it is necessary, in many cases, the administration of medicines that cause dilation of the pupil. As a result, transient visual problems can occur that prevent the use of vehicles and the use of machinery.

HOW TO USE FLUORESCEIN SODIUM INJECTION 10%, INJECTABLE SOLUTION

Fluorescein Ampule 10% is a contrast medium that is used to perform a diagnostic test, which must be performed in the presence of qualified personnel, preferably under the supervision of a physician, who will instruct you at any time the instructions to follow.

The recommended adult dose is one ampoule of 5 ml (500 mg of fluorescein sodium) administered intravenously.

This medicine cannot be given intrathecally or intraarterially.

Use in the elderly

There is no indication that the dose should be modified in elderly patients.

Use in children

No specific studies have been performed in children. If Fluorescein Ampule 10% is used in children, a dose of 5 mg / kg body weight is recommended.

If you use more fluorescein sodium injection 10% of what you should

If you have any further questions on the use of this product, ask your doctor or pharmacist.

POSSIBLE ADVERSE EFFECTS

Like all medicines, Fluorescein Ampule 10% may have side effects, although not everybody gets them.

Gastrointestinal disorders: nausea and vomiting Uncommon (0.1-1%):

Skin and subcutaneous tissue disorders: flushing, pruritus (itching)

Very rarely, the following side effects may also occur:

Immune system disorders: Hypersensitivity reactions (including skin reactions such as urticaria and anaphylaxis / anaphylactoid shock (generalized allergic reaction that in some cases may be severe), cardiovascular symptoms such as hypotension, chest pain, cardiac arrest, acute myocardial infarction Myocardial and severe shock, nervous system disorders such as syncope (fainting), seizures and stroke (brain disorder caused by an alteration in blood vessels in the brain), respiratory symptoms such as dyspnoea (difficulty in breathing), laryngeal edema Inflammation of the larynx that prevents adequate breathing) and bronchospasm Very rare cases of death due to anaphylaxis / anaphylactoid shock (generalized allergic reaction that in some cases may be severe) have been reported.

Nervous system disorders: headache, dizziness.

Skin and subcutaneous tissue disorders: dermatitis, yellowing of the skin transiently, which may last up to 12 hours after administration.

Renal and urinary disorders: bright yellow urine staining for 24 to 36 hours after administration.

General disorders and administration site conditions: chills, hot flashes, thrombophlebitis (inflammation of a vein) at the injection site, extravasation of the solution, causing severe pain and may be followed by tissue necrosis.

If you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.

CONSERVATION OF FLUORESCEIN SODIUM INJECTION 10%, SOLUTION INJECTABLE

Keep out of the reach and sight of children. Do not store above 25 ° C. Keep the blisters in the outer carton.

This medicine should not be used after the expiry date stated on the carton.

ADDITIONAL INFORMATION

- The active substance is sodium fluorescein. 1 ml of solution for injection contains 100 mg of fluorescein sodium. One ampoule of 5 ml of solution contains 500 mg of sodium fluorescein.

- The other ingredients are sodium hydroxide and water for injections.

What the product looks like and contents of the pack

Fluorescein Sodium Injection 10% is an injectable solution that comes in 5 ml colorless glass ampoules. Each box contains 1 or 10 ampoules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

ADDITIONAL INFORMATION OF INTEREST FOR THE SURVEYING FACULTY

This medicine should not be given intrathecally or intra-arterially.

Before administration visually check the absence of particles in the solution and discoloration.

After opening a blister, use it immediately.

Do not mix or dilute with other drugs or solutions in the syringe. To avoid physical incompatibilities, Fluorescein Sodium Injection 10% should not be given simultaneously with injectable solutions of acidic pH medicines (in particular antihistamines) through the same intravenous route as they may precipitate fluorescein. In addition, intravenous cannulas should be washed before and after drug injection.

Before initiating fluorescein injection, precautions should be taken to avoid extravasation and to ensure that the needle is correctly inserted into the vein. High pH of the fluorescein solution can cause severe local tissue damage. Complications secondary to extravasation can lead to severe pain, thrombophlebitis and an inflammatory reaction of the tissue that produces tissue necrosis.

In the event of extravasation, the injection should be stopped immediately and appropriate measures should be taken to relieve the pain and treat the damaged tissue.

During administration, an emergency cart should always be available with appropriate resuscitation equipment including medications used for the treatment of hypersensitivity reactions such as epinephrine, intravenous fluids for volume replacement and corticosteroids.

In patients identified as being at risk of hypersensitivity reactions, but in whom fluorescence angiography is essential, the procedure should be performed in the presence of a resuscitation specialist.

The patient should be kept under close observation for at least 30 minutes after performing fluorescence angiography.

Discard any unused contents.

 

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