ANATERA 100 MG/ML SOLUTION FOR INJECTION
Active substance: FLUORESCEIN SODIUM
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PACKAGE LEAFLET: EN INFORMATION FOR THE USER ANATERA 100 mg/ml solution for injection Fluorescein
Read all of this leaflet carefully before you are given ANATERA 100 mg/ ml solution for injection. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. In this leaflet: 1. What ANATERA 100 mg/ml solution for injection is and what it is used for 2. Before you are given ANATERA 100 mg/ml solution for injection 3. How ANATERA 100 mg/ml solution for injection is given 4. Possible side effects
5. How to store ANATERA 100 mg/ml solution for injection 6. Further information
medicine is for diagnostic use only. It is not used to treat any condition.
1. WHAT ANATERA 100 MG/ML SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR
ANATERA 100 mg/ml solution for injection is a dye solution that makes the blood vessels at the back of your eye visible during an eye examination (this procedure is known as fluorescein angiography). This 2
2. BEFORE YOU ARE GIVEN ANATERA 100 MG/ML SOLUTION FOR INJECTION
You should NOT be given ANATERA 100 mg/ml solution for injection - if you are hypersensitive (allergic) to fluorescein or any other ingredients in ANATERA 100 mg/ml solution for injection. Tell your
doctor if you think you are hypersensitive or allergic to fluorescein or any other ingredients in ANATERA 100 mg/ml solution for injection. Tell your doctor before you are given ANATERA 100 mg/ml solution for injection - if you have pre-existing conditions such as cardiovascular disease or diabetes mellitus. - if you have impaired kidney function. If necessary, your doctor will give a lower dose of ANATERA 100 mg/ml solution for injection. 3
- if you use medicines called beta blockers. Beta blockers are used to treat high blood pressure and a number of heart conditions and are also used in eye drops for the treatment of glaucoma. An allergic reaction to ANATERA 100 mg/ml solution for injection can cause a sudden drop in blood pressure. This may be greater in patients taking beta blockers (such as atenolol, sotalol, propranolol, metoprolol, bisoprolol). - if you have had a reaction to fluorescein before.
You may need to be given another drug to prevent you feeling sick. - if you are on a low sodium diet. ANATERA 100 mg/ml solution for injection contains up to 3.15 mmol (72.45 mg) sodium per dose. If any of the above applies to you, or if you are not sure, please tell your doctor before you are given ANATERA 100 mg/ ml solution for injection. Taking other medicines Please tell your doctor if you are taking or have recently taken any other 4
medicines, including medicines obtained without a prescription. This medicinal product must not be mixed with other medicinal products. Pregnancy and breast feeding Pregnancy Tell your doctor if you are pregnant or are planning to become pregnant. If you are pregnant, ANATERA 100 mg/ml solution for injection should only be used after your doctor has prescribed it. Due to limited experience, caution should be exercised when considering the use of
ANATERA 100 mg/ ml solution for injection during pregnancy. Breast feeding Tell your doctor if you are breast feeding. Fluorescein, the active substance in ANATERA 100 mg/ml solution for injection, passes into the mothers milk where it is slowly eliminated. Therefore, after using ANATERA 100 mg/ml solution for injection, you should not breast feed for 4 days. During this period, breast milk should be expressed and thrown away. Driving and using machines 5
As part of your eye examination, you may be given eye drops which increase the size of the pupil of your eye. This can temporarily affect your vision and your ability to drive or use machines. Do not drive or use machinery until your vision has returned to normal. Important information about some of the ingredients of ANATERA 100 mg/ml solution for injection This medicinal product contains up to 3.15 mmol (72.45 mg) sodium per dose. This should be taken into consideration by patients on a controlled sodium diet.
3. HOW ANATERA 100 MG/ML SOLUTION FOR INJECTION IS GIVEN
ANATERA 100 mg/ml solution for injection will be administered by your doctor. Depending on your condition your doctor may modify the dose. However, since this product has not been studied in children, dose-adaptation data for children are not available. Therefore, ANATERA 100 mg/ml solution for injection should not be used in patients below 18 years as efficacy and 6
safety in this group have not been established. By injection: Usually one vial of ANATERA 100 mg/ml solution for injection is given by injection into a vein in the arm. ANATERA 100 mg/ml solution for injection should not be injected intrathecally or intraarterial. If you have any further questions about how ANATERA 100 mg/ml solution for injection is given, ask your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, ANATERA 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 One or more of these may affect more than 1 in every 10 people. Nausea Common side effects 7
One or more of these may affect up to 10 in every 100 people. Vomiting, stomach problems, fainting, itching, escape of blood or fluid into the tissue, abnormal sense of taste Uncommon side effects One or more of these may affect up to 1 in every 100 people Headache, dizziness, sensation of pins and needles, cough, throat tightness, abdominal pain, hives, impaired speech, pain, feeling hot, hypersensitivity, inflammation of the veins
Rare side effects One or more of these may affect up to 1 in every 1000 people. Severe allergic reaction, cardiac arrest, low blood pressure, shock, difficulty in breathing or wheezing (bronchospasm) Very rare side effects One or more of these may affect up to 1 in every 10000 people. Anaphylactic shock, convulsion, angina pectoris, slow heart rate, fast heart rate, high blood pressure, cramp of blood vessels, cramp in the calf muscles, poor circulation, 8
skin flushing, pallor, hot flush, stopping breathing, fluid on the lungs, asthma, decreased breathing function, swelling of the larynx, shortness of breath, swelling of the nose, sneezing. Not known (frequency cannot be estimated from the available data) Loss of consciousness, shaking, abnormal or decreased skin sensation, rash, cold sweat, skin inflammation, sweating, oedema, generalised weakness, myocardial infarction.
After receiving ANATERA 100 mg/ml solution for injection, you may experience a change in the way things taste. Your skin may appear yellowish; this discoloration usually disappears after 6-12 hours. Your urine also may appear bright yellow; this may take 24-36 hours to return to normal. After injection, inflammation of the vein and blood clots in the vein may occur. If during injection the solution leaks from the vein into the surrounding tissues, it can cause damage to the skin and inflammation of the veins, nerves and tissues close to the injection site; this can lead to severe 9
pain. If you notice any pain or other problems at the injection site, tell your doctor; you may need to be given pain medication or other treatment to help with this. As listed previously, fluorescein can have unexpectedly severe side effects. These are more likely if you have suffered a reaction to fluorescein before or if you suffer from allergies (food or drug allergies), eczema, asthma or hay fever. If you experience any of the side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Blood and urine tests It is possible that fluorescein may affect certain blood and urine tests for 3 to 4 days after you are given it. If you have any blood or urine tests or further X-rays during this period, tell your doctor that you have been given fluorescein.
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5. HOW TO STORE ANATERA 100 MG/ML SOLUTION FOR INJECTION
-
- Keep out of the reach and sight of children. - Do not use ANATERA 100 mg/ml solution for injection after the expiry date which is stated on
the label and outer carton (marked Exp). The expiry date refers to the last day of that month. Once opened the vial must be used immediately. Your doctor or nurse knows how to store ANATERA 100 mg/ml solution for injection: Do not store above 25C. Do not freeze. Keep the vial in the outer carton in order to protect from light. Do not use ANATERA 100 mg/ml solution for injection if the vial is cracked or damaged in any way.
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- The solution is to be inspected visually for particulate matter and
discoloration prior to administration. The solution should only be used if the solution is clear and free from particles. - Any unused product or waste material should be disposed of in accordance with local requirements.
One vial with 5 ml contains 500 mg fluorescein (as 566 mg fluorescein sodium). The other ingredients are sodium hydroxide and / or hydrochloric acid (used to adjust the pH of the solution) and water for injections. What ANATERA 100 mg/ml solution for injection looks like and contents of the pack ANATERA 100 mg/ml solution for injection is a clear red-orange solution for injection. ANATERA 100 mg/ ml solution for injection is available in packages containing 12 vials of 5 ml solution for injection.
6. FURTHER INFORMATION
What ANATERA 100 mg/ml solution for injection contains The active substance is fluorescein. 1 ml of solution contains 100 mg fluorescein (as 113.2 mg fluorescein sodium). 11
Marketing Authorisation Holder Alcon Laboratories (U.K.) Ltd. Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom PA290/78/1; PL00649/0377 This product is also authorised in the EU under the following names: Fluorescein ALCON 10% Manufacturer S. A. Alcon-Couvreur N. V. Rijksweg 14 B-2870 Puurs Belgium This leaflet was last approved in April 2012 2010, 2012 Novartis
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Read all of this leaflet carefully before you are given ANATERA 100 mg/ ml solution for injection. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. In this leaflet: 1. What ANATERA 100 mg/ml solution for injection is and what it is used for 2. Before you are given ANATERA 100 mg/ml solution for injection 3. How ANATERA 100 mg/ml solution for injection is given 4. Possible side effects
5. How to store ANATERA 100 mg/ml solution for injection 6. Further information
medicine is for diagnostic use only. It is not used to treat any condition.
1. WHAT ANATERA 100 MG/ML SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR
ANATERA 100 mg/ml solution for injection is a dye solution that makes the blood vessels at the back of your eye visible during an eye examination (this procedure is known as fluorescein angiography). This 2
2. BEFORE YOU ARE GIVEN ANATERA 100 MG/ML SOLUTION FOR INJECTION
You should NOT be given ANATERA 100 mg/ml solution for injection - if you are hypersensitive (allergic) to fluorescein or any other ingredients in ANATERA 100 mg/ml solution for injection. Tell your
doctor if you think you are hypersensitive or allergic to fluorescein or any other ingredients in ANATERA 100 mg/ml solution for injection. Tell your doctor before you are given ANATERA 100 mg/ml solution for injection - if you have pre-existing conditions such as cardiovascular disease or diabetes mellitus. - if you have impaired kidney function. If necessary, your doctor will give a lower dose of ANATERA 100 mg/ml solution for injection. 3
- if you use medicines called beta blockers. Beta blockers are used to treat high blood pressure and a number of heart conditions and are also used in eye drops for the treatment of glaucoma. An allergic reaction to ANATERA 100 mg/ml solution for injection can cause a sudden drop in blood pressure. This may be greater in patients taking beta blockers (such as atenolol, sotalol, propranolol, metoprolol, bisoprolol). - if you have had a reaction to fluorescein before.
You may need to be given another drug to prevent you feeling sick. - if you are on a low sodium diet. ANATERA 100 mg/ml solution for injection contains up to 3.15 mmol (72.45 mg) sodium per dose. If any of the above applies to you, or if you are not sure, please tell your doctor before you are given ANATERA 100 mg/ ml solution for injection. Taking other medicines Please tell your doctor if you are taking or have recently taken any other 4
medicines, including medicines obtained without a prescription. This medicinal product must not be mixed with other medicinal products. Pregnancy and breast feeding Pregnancy Tell your doctor if you are pregnant or are planning to become pregnant. If you are pregnant, ANATERA 100 mg/ml solution for injection should only be used after your doctor has prescribed it. Due to limited experience, caution should be exercised when considering the use of
ANATERA 100 mg/ ml solution for injection during pregnancy. Breast feeding Tell your doctor if you are breast feeding. Fluorescein, the active substance in ANATERA 100 mg/ml solution for injection, passes into the mothers milk where it is slowly eliminated. Therefore, after using ANATERA 100 mg/ml solution for injection, you should not breast feed for 4 days. During this period, breast milk should be expressed and thrown away. Driving and using machines 5
As part of your eye examination, you may be given eye drops which increase the size of the pupil of your eye. This can temporarily affect your vision and your ability to drive or use machines. Do not drive or use machinery until your vision has returned to normal. Important information about some of the ingredients of ANATERA 100 mg/ml solution for injection This medicinal product contains up to 3.15 mmol (72.45 mg) sodium per dose. This should be taken into consideration by patients on a controlled sodium diet.
3. HOW ANATERA 100 MG/ML SOLUTION FOR INJECTION IS GIVEN
ANATERA 100 mg/ml solution for injection will be administered by your doctor. Depending on your condition your doctor may modify the dose. However, since this product has not been studied in children, dose-adaptation data for children are not available. Therefore, ANATERA 100 mg/ml solution for injection should not be used in patients below 18 years as efficacy and 6
safety in this group have not been established. By injection: Usually one vial of ANATERA 100 mg/ml solution for injection is given by injection into a vein in the arm. ANATERA 100 mg/ml solution for injection should not be injected intrathecally or intraarterial. If you have any further questions about how ANATERA 100 mg/ml solution for injection is given, ask your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, ANATERA 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 One or more of these may affect more than 1 in every 10 people. Nausea Common side effects 7
One or more of these may affect up to 10 in every 100 people. Vomiting, stomach problems, fainting, itching, escape of blood or fluid into the tissue, abnormal sense of taste Uncommon side effects One or more of these may affect up to 1 in every 100 people Headache, dizziness, sensation of pins and needles, cough, throat tightness, abdominal pain, hives, impaired speech, pain, feeling hot, hypersensitivity, inflammation of the veins
Rare side effects One or more of these may affect up to 1 in every 1000 people. Severe allergic reaction, cardiac arrest, low blood pressure, shock, difficulty in breathing or wheezing (bronchospasm) Very rare side effects One or more of these may affect up to 1 in every 10000 people. Anaphylactic shock, convulsion, angina pectoris, slow heart rate, fast heart rate, high blood pressure, cramp of blood vessels, cramp in the calf muscles, poor circulation, 8
skin flushing, pallor, hot flush, stopping breathing, fluid on the lungs, asthma, decreased breathing function, swelling of the larynx, shortness of breath, swelling of the nose, sneezing. Not known (frequency cannot be estimated from the available data) Loss of consciousness, shaking, abnormal or decreased skin sensation, rash, cold sweat, skin inflammation, sweating, oedema, generalised weakness, myocardial infarction.
After receiving ANATERA 100 mg/ml solution for injection, you may experience a change in the way things taste. Your skin may appear yellowish; this discoloration usually disappears after 6-12 hours. Your urine also may appear bright yellow; this may take 24-36 hours to return to normal. After injection, inflammation of the vein and blood clots in the vein may occur. If during injection the solution leaks from the vein into the surrounding tissues, it can cause damage to the skin and inflammation of the veins, nerves and tissues close to the injection site; this can lead to severe 9
pain. If you notice any pain or other problems at the injection site, tell your doctor; you may need to be given pain medication or other treatment to help with this. As listed previously, fluorescein can have unexpectedly severe side effects. These are more likely if you have suffered a reaction to fluorescein before or if you suffer from allergies (food or drug allergies), eczema, asthma or hay fever. If you experience any of the side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Blood and urine tests It is possible that fluorescein may affect certain blood and urine tests for 3 to 4 days after you are given it. If you have any blood or urine tests or further X-rays during this period, tell your doctor that you have been given fluorescein.
-
-
5. HOW TO STORE ANATERA 100 MG/ML SOLUTION FOR INJECTION
-
- Keep out of the reach and sight of children. - Do not use ANATERA 100 mg/ml solution for injection after the expiry date which is stated on
the label and outer carton (marked Exp). The expiry date refers to the last day of that month. Once opened the vial must be used immediately. Your doctor or nurse knows how to store ANATERA 100 mg/ml solution for injection: Do not store above 25C. Do not freeze. Keep the vial in the outer carton in order to protect from light. Do not use ANATERA 100 mg/ml solution for injection if the vial is cracked or damaged in any way.
10
- The solution is to be inspected visually for particulate matter and
discoloration prior to administration. The solution should only be used if the solution is clear and free from particles. - Any unused product or waste material should be disposed of in accordance with local requirements.
One vial with 5 ml contains 500 mg fluorescein (as 566 mg fluorescein sodium). The other ingredients are sodium hydroxide and / or hydrochloric acid (used to adjust the pH of the solution) and water for injections. What ANATERA 100 mg/ml solution for injection looks like and contents of the pack ANATERA 100 mg/ml solution for injection is a clear red-orange solution for injection. ANATERA 100 mg/ ml solution for injection is available in packages containing 12 vials of 5 ml solution for injection.
6. FURTHER INFORMATION
What ANATERA 100 mg/ml solution for injection contains The active substance is fluorescein. 1 ml of solution contains 100 mg fluorescein (as 113.2 mg fluorescein sodium). 11
Marketing Authorisation Holder Alcon Laboratories (U.K.) Ltd. Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom PA290/78/1; PL00649/0377 This product is also authorised in the EU under the following names: Fluorescein ALCON 10% Manufacturer S. A. Alcon-Couvreur N. V. Rijksweg 14 B-2870 Puurs Belgium This leaflet was last approved in April 2012 2010, 2012 Novartis
12
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
