Flolan 0,5 mg polvo y disolvente para solucion para perfusion
Introduction
Prospect: information for the user
Flolan 0.5 mg powder and solvent for solution for infusion
Epoprostenol
Read this prospect carefully before starting to use this medication,because it contains important information for you.
- Keep this prospect, as you may need to read it again.
- If you have any doubts, consult yourdoctor,pharmacistor nurse.
- This medication has been prescribedonlyto you, and you should not give it to other people
althoughtheymayhavethe same symptomsas you,as it may harm them.
- If you experience any adverse effects,consult your doctor, pharmacist or nurse,eveniftheyare not listed in this prospect. See section 4.
1.What is Flolan and how it is used
2.What you need to knowbeforestarting touse Flolan
3.How to use Flolan
4.Possible adverse effects
5.Storage of Flolan
6.Contents of the package and additional information
1. What is Flolan and what is it used for
What is Flolan
Flolan contains the active ingredient epoprostenol, which belongs to a group of medications called prostaglandins that prevent blood coagulation and dilate blood vessels.
What is Flolan used for
- Flolan is used to treat a lung disease known as “pulmonary arterial hypertension”. This occurs when the blood pressure in the pulmonary vessels is high. Flolan dilates the blood vessels to reduce blood pressure in the lungs.
- Flolan is used to prevent blood coagulation during renal dialysis, in emergency situations, when heparin cannot be used.
2. What you need to know before starting to use Flolan
Do not use Flolan
- if you are allergicto epoprostenol orany of the other components ofthis medication (listed in section 6)
- if you haveheart failure.
- if you start to develop fluid accumulation in your lungs causing difficulty breathing after starting treatment.
If you think any of these situations apply to you,do not useFlolanuntil you have consulted your doctor.
Warnings and precautions
Inform your doctor before using Flolan:
- if you havebleeding problems
- if you are on a low-sodium diet.
Skin lesion at the injection site
Flolan is injected into a vein. It is essential that the medication does not leak or filter out of the vein into the surrounding tissues. If it does, it will damage the skin. Symptoms are:
- sensitivity
- burning
- itching
- swelling
- redness.
This may continue with blister formation and skin peeling. It is essential that you monitor the injection area while being treated with Flolan.
Contact the hospital immediatelyif the injection site becomes painful, itches, or swells, or if you notice any blister formation or skin peeling.
Effect of Flolan on blood pressure and heart rate
Flolan may speed up or slow down the heartbeat. Your blood pressure may also become very low. While being treated with Flolan, your heart rate and blood pressure should be monitored. Symptoms of low blood pressure includedizzinessandsyncope.
Inform your doctorif you experience any of these symptoms. You may need to reduce your dose or stop the infusion.
Use of Flolan with other medications
Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may need to take any other medication, including those purchased without a prescription.
Some medications may affect the functioning of Flolan, or make it more likely that you will experience adverse effects. Flolan may also affect the functioning of other medications if taken at the same time. These include:
- medications usedto treat high blood pressure
- medications used toprevent blood clot formation
- medications used todissolve blood clots
- medications used totreat inflammation or pain(also known as NSAIDs)
- digoxin (used to treatcardiac arrhythmias).
Inform your doctor or pharmacistif you are taking any of these medications.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication as symptoms may worsen during pregnancy.
The components of Flolan are unknown to pass into breast milk.You should stop breastfeeding while being treated with Flolan.
Driving and operating machinery
The treatment may affect your ability to drive and operate machinery.
Do not drive or operate machineryunless you feel well.
Flolan contains sodium (main component of table salt/cooking salt)
Patients on low-sodium diets should note that this reconstituted medication contains 73 mg of sodium per dose.
Reconstituted solution concentrate:This medication contains 73 mg of sodium (main component of table salt/cooking salt) in each vial of solution concentrate. This is equivalent to 4% of the maximum daily sodium intake recommended for an adult.
Powder for solution for infusion:This medication contains 3 mg of sodium (main component of table salt/cooking salt) in each vial of powder for solution. This is equivalent to 0.2% of the maximum daily sodium intake recommended for an adult..
Parenteral solvent:This medication contains 70 mg of sodium (main component of table salt/cooking salt) in each vial of solvent. This is equivalent to 4% of the maximum daily sodium intake recommended for an adult.
3. How to Use Flolan
Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.
Your doctor will tell you how much Flolan is suitable for you. The amount you are administered is based on your body weight and the type of disease. Your dose may be increased or decreased depending on how well you respond to treatment.
Flolan is administered through slow infusion (drip) in a vein.
Pulmonary Arterial Hypertension
The first treatment will be administered in a hospital. This is because your doctor needs to monitor you and identify the best dose for you.
Flolan infusion will be started. The dose will be increased gradually until your symptoms improve and side effects are controlled. Once the best dose is identified, a permanent catheter (line) will be placed in one of your veins. You will then be treated with a pump for infusion.
Renal Dialysis
Flolan infusion will be administered during the duration of your dialysis.
Use of Flolan at Home (only for the treatment of Pulmonary Arterial Hypertension)
If you are being treated at home, your doctor or nurse will teach you how to prepare and use Flolan. They will also tell you how to interrupt treatment if necessary. Discontinuation of Flolan should be done gradually. It is essential that you carefully follow all instructions.
Flolan comes as a powder in a glass vial. Before use, the powder needs to be dissolved in the provided liquid. The liquid does not contain preservatives. You should discard any unused liquid.
Care of the Catheter
If a catheter has been placed in a vein, it is very important to keep this area clean, as it could become infected. Your doctor or nurse will teach you how to clean the catheter and the area around it. It is very important that you carefully follow all instructions.
If you use more Flolan than you should
Seek urgent medical attentionif you think you have used or been administered too much Flolan. Symptoms of overdose may include headache, nausea, vomiting, rapid heartbeat, heat or tingling sensation, or feeling like you may faint (dizziness).
If you forgot to use Flolan
Do not use a double dose to compensate for the missed doses.
If you interrupt treatment with Flolan
Discontinuation of Flolan should be done gradually. If you interrupt treatment too quickly, you may experience severe side effects, including dizziness, feeling weak, and difficulty breathing. If you have problems with the infusion pump or catheter, because it stops or prevents treatment with Flolan,contact your doctor, nurse, or hospital immediately.
If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.
4. Possible Adverse Effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Inform your doctor or nurse immediately, as these may be signs of blood infection or low blood pressure or severe bleeding:
- You feel your heart beating faster, or you have chest pain or difficulty breathing.
- You feel dizzy or feel faint, especially when standing.
- You have a fever or chills.
- You bleed more frequently or for longer periods.
If you experience side effects, consult your doctor, pharmacist, or nurse,even if they are side effects that do not appear in this leaflet.
Very common side effects
Thesemay affectmore than 1 in 10people:
- headache
- jaw pain
- unspecified pain
- vomiting
- nausea
- diarrhea
- flushing of the face (facial flushing).
Common side effects
Thesemay affectup to 1 in 10people:
- blood infection (septicemia)
- rapid heartbeat
- slow heartbeat
- low blood pressure
- bleeding in various locations and increased ease of bruising; for example, nosebleeds or gum bleeding
- uncomfortable or stomach pain
- chest pain
- joint pain
- sensation of anxiety, sensation of nervousness
- skin rash
- pain at the injection site.
Common side effectsthat may appear in your blood tests
- decrease in the number of platelets in the blood (cells that help blood clotting).
Rare side effects
Thesemay affectup to 1 in 100people:
- sweating
- dry mouth.
Uncommon side effects
These may affectup to 1 in 1,000people:
- infection at the injection site.
Very rare side effects
Thesemay affectup to 1 in 10,000people:
- sensation of pressure around the chest
- fatigue, weakness
- agitation
- pallor
- flushing at the injection site
- hyperactive thyroid glands
- intravenous catheter occlusion.
Other side effects
We do not know how many people are affected:
- enlarged or hyperactive spleen
- fluid accumulation in the lungs (pulmonary edema)
- increased blood sugar (glucose) in the blood
- swelling due to fluid accumulation around the stomach
- excessive blood pumping from the heart that leads to difficult breathing, fatigue, swelling of the legs and abdomen due to fluid retention, persistent cough.
Reporting side effects
If you experienceany type of side effect, consult your doctor, pharmacist, or nurse, even if it is apossibleside effect that does not appear in this leaflet.
You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use,www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Flolan Storage
Keepthis medicationout of the sight and reach of children.
Do not usethis medicationafter the expiration date that appears onthe label.
Do not store above25°C.
Store Flolan in a dry place.
Store in the original container to protect it from light.
Do not freeze.
Pulmonary Arterial Hypertension
For solutions ≤ 150,000 ng/ml:
The freshly prepared Flolan solution (whether as a concentrated or more diluted solution) can be administered immediately or stored for a maximum of 8 days in the refrigerator (between 2°C and 8°C), in the medication case and used within a maximum period of:
• 72 hours at 25°C or
• 48 hours at 30°C or
• 24 hours at 35°C or
• 12 hours at 40°C.
For solutions > 150,000 ng/ml and ≤ 300,000 ng/ml:
Reconstituted solutions that have been stored at 2-8°C for up to 7 days can be administered for up to 24 hours at 25°C.
Reconstituted solutions that have just been prepared or those solutions that have been stored at 2-8°C for no more than 5 days can be administered for:
• 48 hours at 25°C
• 24 hours at 35°C
Discard any unused solution after that time.
Renal Dialysis
Once Flolan has dissolved and been diluted, any solution that has not been used can be stored at25°Cand used within the next 12 hours.
Medicines should not be thrown away through the drains or in the trash. Deposit the containers and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medicines. By doing so, you will help protect the environment.
6. Contents of the packaging and additional information
Composition of Flolan
The active ingredient is epoprostenol sodium.
Each vial contains:
- 0.5 mg of epoprostenol sodium
- See Section 2 for more important information about sodium.
The other components are mannitol, glycine, sodium chloride, sodium hydroxide, and water for injection preparations.
Appearance of the product and contents of the package
Injection:
Flolan is a parenteral solution composed of powder and solvent. The powder is white to off-white and the solution is transparent and colorless.
There are three Flolan packages available for use in pulmonary arterial hypertension, the contents of each package include:
- A vial of 0.5 mg of powder and a vial of solvent, a vial adapter, and a filter.
- A vial of 0.5 mg of powder and two vials of solvent, two vial adapters, and a filter.
- A vial of 0.5 mg of powder.
There is only one Flolan package available for use in renal dialysis, the contents of each package include:
- A vial of 0.5 mg of powder and a vial of solvent, a vial adapter, and a filter.
Only some package sizes may be marketed.
Marketing authorization holder and responsible manufacturer
Marketing authorization holder:
GlaxoSmithKline, S.A.
P.T.M. C/ Severo Ochoa, 2
28760 Tres Cantos (Madrid)
Tel: +34 900 202 700
Responsible manufacturer:
GlaxoSmithKline Manufacturing, S.p.A.
Strada Provinciale Asolana, 90
43056 San Polo di Torrile, Parma, Italy.
or
GlaxoSmithKline Pharmaceuticals S.A.
Ul. Grunwaldzka
60-322 Poznan
Poland.
or
Glaxo Wellcome GmbH & Co.KG
Industriestrasse 32-36
23843 Bad Oldesloe
Germany.
This medicinal product is authorized in the Member States of the European Economic Area with the following names:
AustriaFlolan
BelgiumFlolan
Czech RepublicFlolan
DenmarkEpoprostenol
EstoniaFlolan
FranceFlolan
IrelandFlolan
ItalyFlolan
LuxembourgFlolan
MaltaFlolan
NetherlandsFlolan
NorwayFlolan
SpainFlolan
United KingdomFlolan
Last update date of thisleaflet: March 2021
The detailed and updated information of this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/
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This information is intended solely for medical professionals or healthcare professionals:
- INFORMATION FOR HEALTHCARE PROFESSIONALS
Pulmonary arterial hypertension
There are three packages available for use in pulmonary arterial hypertension:
- A vial of 0.5 mg of powder, a vial of solvent, a vial adapter, and a filter.
- A vial of 0.5 mg of powder, two vials of solvent, two vial adapters, and a filter.
- A vial of 0.5 mg of powder.
Only some package sizes may be marketed.
Initially, a package containing a solvent for parenteral use should be used. Higher concentrations may be required during chronic treatment with Flolan. The final concentrated solution can be increased by adding another vial of 0.5 mg of Flolan lyophilized powder.
Only vials of the same amount of Flolan lyophilized powder as those included in the initial package should be used to increase the final concentration of the solution.
Flolan prepared with sterile solvent (pH 11.7-12.3) should not be used with any preparation or administration material containing polyethylene terephthalate (PET) or polyethylene terephthalate modified with glycol (PETG). Based on the available internal analysis data and published literature, compatible preparation and administration materials include:
- Modified acrylic
- Acrylonitrile butadiene styrene (ABS)
- Cyclic olefin polymer
- Nylon
- Polysulfone
- Polyethylene
- Isoprene
- Olefin
- Propylene
- Polytetrafluoroethylene (PTFE)
- Urethane
- Chlorinated polyvinyl chloride (PVC) (plasticized with bis(2-ethylhexyl) phthalate (DEHP)
- Fluorinated polyvinylidene (PVDF)
- Silicone
Appropriate ambulatory pumps for use include:
- CADD- Legacy 1
- CADD- Legacy PLUS
- CADD-Solis VIP (variable perfusion profile)
Manufactured by Smiths Medical.
Compatible accessories for the pumps include:
- CADD medication cassette “reservoir” 50 ml; and 100 ml from Smiths Medical.
- CADD extension set with in-line filter (CADD extension set with male luer; 0.2 micron air elimination filter, clamp, and integral anti-siphon valve with male luer) from Smiths Medical.
The extension set and in-line filter should be changed at least every 48 hours.
Reconstitution:
1.Only the provided solvent should be used for reconstitution.
2.Remove approximately 10 ml of solvent with a sterile syringe, through a vial adapter*.
3.Remove the syringe from the vial adapter. Connect the needle to the syringe, inject the 10 ml of solvent into the vial containing Flolan powder and gently shake until the powder is dissolved.
4.Extract the resulting Flolan solution from the syringe, remove the needle, re-inject it into the remaining solvent volume through the vial adapter* and mix well.
*Alternatively, a needle can be used instead of a vial adapter.
This solution is now called the concentrated solution and contains 10,000 nanograms per ml of Flolan. Only the concentrated solution is suitable for further dilution before use. Use a new vial adapter for each additional vial of sterile solvent that is needed. When 0.5 mg of Flolan powder is reconstituted with 50 ml of solvent, the final injection will have a pH of approximately 12 and a sodium ion content of approximately 73 mg.
Dilution:
Flolan can be used in concentrated solution or diluted solution for the treatment of pulmonary arterial hypertension. Only the concentrated solution is suitable for further dilutions with sterile solvent before use. Only the provided solvent should be used for the subsequent dilution of reconstituted Flolan, using a new vial adapter for each additional vial of sterile solvent that is needed.
Sodium chloride 0.9% w/v solution should not be used if Flolan is to be administered for the treatment of pulmonary arterial hypertension, as the pH will not be maintained. Flolan solutions are less stable at low pH.
Epoprostenol should not be administered with other parenteral solutions when administered for pulmonary arterial hypertension.
The final solution to be administered to the patient should be filtered using a 0.22 or 0.20 micron filter. It is preferable to use an in-line filter as part of the perfusion equipment during administration. Alternatively, when it is not possible to use an in-line filter, the final solution (either as a concentrated solution or more diluted) should be filtered with the provided sterile 0.22 micron filter before being stored in the medication cassette, applying firm but not excessive pressure. The usual time for filtering 50 ml of solution is 70 seconds.
If an in-line filter has been used during administration, it should be discarded when changing the perfusion equipment.
If, on the other hand, a syringe filter has been used during preparation, it should be used only for preparation and discarded afterwards. The usual concentrations used in the treatment of pulmonary arterial hypertension are as follows:
- 5,000 nanograms/ml – a vial containing 0.5 mg of Flolan reconstituted and diluted to a total volume of 100 ml in the solvent.
- 10,000 nanograms/ml - two vials containing 0.5 mg of Flolan reconstituted and diluted to a total volume of 100 ml in the solvent.
Calculation of perfusion rate:
The perfusion rate can be calculated from the following formula:
dose (nanograms/kg/min) x body weight (kg)
Perfusion rate (ml/min) =
concentration of the solution (nanograms/ml)
Perfusion rate (ml/h) = perfusion rate (ml/min) x 60
In long-term administration of Flolan, higher perfusion rates may be required, and therefore, more concentrated solutions.
Special precautions for storage
Do not store above25°C.
Store the package within the carton to protect it from light.
Keep in a dry place.
Do not freeze.
For more details on stability after reconstitution, see Section 5 (Storage of Flolan).
The solvent does not contain preservatives; therefore, each vial should be used only once and discarded afterwards.
Renal dialysis
Only one package is available for use in renal dialysis:
- A vial of 0.5 mg of powder and a vial of solvent, a vial adapter, and a filter.
Flolan prepared with sterile solvent (pH 12) should not be used with any preparation or administration material containing polyethylene terephthalate (PET) or polyethylene terephthalate modified with glycol (PETG). Based on the available internal analysis data and published literature, compatible preparation and administration materials include:
- Modified acrylic
- Acrylonitrile butadiene styrene (ABS)
- Cyclic olefin polymer
- Nylon
- Polysulfone
- Polyethylene
- Isoprene
- Olefin
- Propylene
- Polytetrafluoroethylene (PTFE)
- Urethane
- Chlorinated polyvinyl chloride (PVC) (plasticized with bis(2-ethylhexyl) phthalate (DEHP)
- Fluorinated polyvinylidene (PVDF)
- Silicone
Reconstitution:
1. Only the provided solvent should be used for reconstitution.
2. Remove approximately 10 ml of solvent with a sterile syringe, through a vial adapter*.
3. Remove the syringe from the vial adapter. Connect the needle to the syringe, inject the 10 ml of solvent into the vial containing the 0.5 mg of Flolan lyophilized powder and gently shake until the powder is dissolved.
4. Extract the resulting Flolan solution from the syringe, remove the needle, re-inject it into the remaining solvent volume through the vial adapter* and mix well.
*Alternatively, a needle can be used instead of a vial adapter.
This solution is now called the concentrated solution and contains 10,000 nanograms per ml of Flolan. Only the concentrated solution is suitable for further dilution before use. When 0.5 mg of Flolan powder for intravenous infusion is reconstituted with 50 ml of solvent, the final injection will have a pH of approximately 12 and a sodium ion content of approximately 73 mg.
Dilution:
Normally, the concentrated solution is usually diluted again immediately before use. It can be diluted with a 0.9% w/v sodium chloride solution (normal saline), in a ratio of 2.3 volumes of normal saline to 1 volume of concentrated solution; for example, 50 ml of concentrated solution diluted with 117 ml of normal saline.
Other common IV fluids are not suitable for diluting the concentrated solution, as the pH will not be maintained. Flolan solutions are less stable at low pH.
Epoprostenol should not be administered with other parenteral solutions when administered for renal dialysis.
The final solution for perfusion (either as a concentrated solution or more diluted) should be transferred to a suitable container or administration system before administration. During transfer, a sterile 0.22 micron filter should be used, applying firm but not excessive pressure. The usual time for filtering 50 ml of solution is 70 seconds.
If an in-line filter has been used during administration, it should be discarded when changing the perfusion equipment.
If, on the other hand, a syringe filter has been used during preparation, it should be used only for preparation and discarded afterwards. The usual concentrations used in the treatment of renal dialysis are as follows:
- 10,000 nanograms/ml - a vial containing 0.5 mg of Flolan reconstituted and diluted to a total volume of 50 ml in the solvent.
Calculation of perfusion rate:
The perfusion rate can be calculated from the following formula:
dose (nanograms/kg/min) x body weight (kg)
Perfusion rate (ml/min) =
concentration of the solution (nanograms/ml)
Perfusion rate (ml/h) = perfusion rate (ml/min) x 60
For administration using a pump capable of delivering constant small volume perfusions, the concentrated solution can be diluted with a sterile 0.9% w/v sodium chloride solution.
The detailed and updated information of this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/
INSTRUCTIONS FOR USE
Flolan Solution
Instructions for use with a vial adapter and ambulatory infusion pumps
Please read these instructions before starting to prepare your Flolan solution. If you have any questions or doubts, contact your doctor.
- Wash your hands thoroughly before handling the necessary elements.
- Put on your gloves before the “Preparation” of Flolan (Step 1).
- Keep your workspace and the necessary elements for Flolan preparation clean and dry to ensure that you prepare Flolan in a hygienic manner.
- Always follow your doctor's instructions exactly. The information in these instructions for use serves as a reminder of the process.
Storage information
- Keep out of the sight and reach of children.
- Store Flolan in a cool and dry place.
- Protect from light by keeping Flolan in its carton until it is used.
Do notuse Flolan after the expiration date on the label.
Do notfreeze.
Your package will contain the following: |
•1 vial of powder, 1 vial of solvent, 1 vial adapter, and a filter; or •1 vial of powder, 2 vials of solvent, 2 vial adapters, and a filter; or •1 vial of powder |
You will also need (not supplied): |
1 syringe of 60 ml • 1 needle • 1 cassette • 1 ambulatory pump • 1 perfusion equipment • Gloves • Alcohol wipes |
Preparation | |
| |
Use only the solvent provided for reconstitution. •Remove the cap from the solvent vial and clean the rubber stopper with an alcohol wipe. | |
2.Open the vial adapter package | |
• Remove the protective paper from the vial adapter package. Nota:keep the vial adapter in its package for the next step. Do notuse the vial adapter if the package is damaged. Contact your doctor or pharmacist for more information. Do notuse the vial adapter if it falls out of the package. |
3.Connectthe vial adapter | |
• Hold the vial adapter by its package and place the inner tip vertically into the rubber stopper of the solvent vial until the vial adapter fits into place. •Check that the vial adapter is properly seated before removing the package. •Clean the tip of the vial adapter with an alcohol wipe. Do nottouch the tip of the vial adapter or the syringe. |
4.Connect the syringe without the needle | |
•Connect the syringe directly to the vial adapter without using the needle. •Hold the base of the vial adapter while connecting the syringe. •Press and twist the syringe 180° clockwise in the direction of the arrows on the vial adapter. Do notinsert the needle into the syringe. | |
5.Extract the solvent | |
•Hold the vial securely above the syringe. •Remove 10 ml of the sterile solvent solution from the vial into the syringe, through the vial adapter. | |
6.Back off the syringe | |
•Orient the tip of the syringe upwards and, while holding the lower part of the vial adapter, remove the vial adapter from the syringe. Back off the syringe in a counterclockwise direction to remove it from the vial adapter. Nota:if you are preparing a solution, go to step 7. If you are injecting directly, go to step 13. |
Preparing the solution of Flolan | |
7.Insert the needle | |
• Remove the package from the needle. • Insert the needle into the syringe. • Remove the cap from the needle. Nota:confirm that the needle is securely inserted before removing the cap from the needle. Be careful not to touch the tip of the needle. | |
8.Inject the solution into the Flolan powder vial | |
•Remove the cap from the Flolan powder vial and clean the rubber stopper with an alcohol wipe. •Insert the needle of the syringe vertically through the center of the rubber stopper and inject the 10 ml of solvent into the vial containing the powder. | |
9.Mix the solution gently | |
•With the needle still inserted in the vial, gently shake the mixture until the powder is dissolved and the solution is transparent.
|
10. Extract the prepared solution | |
•When the solution is transparent, place the vial upside down and, with the syringe pointing upwards, extract the Flolan solution into the syringe. •Remove the needle from the vial. | |
11.Inject the solution into the solvent | |
•Remove the needle from the syringe and discard it in a sharp object container. Do notuse the needle with the vial adapter. | |
12.Mix well | |
•Mix well. • Extract the entire volume of the concentrated solution from the vial. • Disconnect the syringe from the vial adapter as shown in step 6. Nota: this concentrated solution is the only one suitable for further dilutions before use. |
Preparing the cassette | |
*The steps in orange are optional: only when necessary | |
*Connect the syringe filter | |
Nota: a filter in-line should be provided as part of your extension equipment (see step 15). If a filter in-line is not provided as part of your extension equipment, then you must use the provided syringe filter to filter the solution during the preparation of the cassette. • Connect the provided sterile syringe filter to the syringe. • Connect the filter and syringe to the cassette with the tube. |
13. Fill the cassette | |
• Connect the syringe to the cassette tube. • Inject the contents of the syringe slowly into the cassette. • Use the syringe to remove any excess air from the cassette. Nota: make sure the sliding clamp is open. | |
*Solution diluent | |
Nota:if you need to dilute your dose, prepare a solution of solvent to inject by repeating steps 1 to 6 and 13. For the volume of solvent to be extracted, follow the instructions below, instead of step 5. • Hold the vial securely above the syringe. • Extract the necessary volume of solvent (or solution) from the vial. |
14.Mix the cassette gently | |
• Secure the sliding clamp. • Mix well, rotating or gently turning the cassette. Do notshake the cassette. | |
15.Ambulatory pump | |
•Consult the instructions for using your ambulatory pump. |
Disposal |
Dispose of used items |
•Dispose of the used filter after completing the preparation of your Flolan solution, along with the other used items. You must also dispose of any remaining pH 12 solvent, as it does not contain preservatives. |
Storage (Solutions with a concentration of150,000 ng/ml or less) |
Storage of the prepared solution |
•Once you have finished preparing your Flolan solution, you can use it immediately or store it in the refrigerator for up to 8 days at 2-8°C. • Store your Flolan cassettes in the top shelf of the refrigerator, in a secure and well-fitting container, and make sure they are kept separate from food. Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care. |
