0.19 mg / ml solution for injection Perflutren –
filled microspheres
What OPTISON is and what it is used for
OPTISON is an ultrasound contrast agent that helps to get clearer images of the heart during echocardiography (a procedure where you get an image of the heart using ultrasound). OPTISON makes it easier to see the inner heart walls of patients where the heart walls are difficult to see.
OPTISON contains microspheres (very small gas bubbles) that, after injection, travel through the veins to the heart and fill the left cavity of the heart so that the doctor can see and assess the heart’s function.
Intended for diagnostics only.
What you need to know before using OPTISON
Do not use OPTISON
- if you are allergic (hypersensitive) to perflutren or any of the other ingredients of this medicine (listed in section 6).
- if you have severe pulmonary hypertension (systolic pulmonary arterial pressure> 90 mm Hg).
Warnings and cautions
Talk to your doctor before using OPTISON
- if you have any known allergies .
- if you have severe heart, lung, kidney or liver disease. Experience with OPTISON in severely ill patients is limited.
- if you have a heart valve prosthesis.
- if you have acute severe inflammation or sepsis .
- if you have a known problem with blood clotting.
Your heart activity and heart rate will be monitored when you receive OPTISON.
Children and young people
Efficacy and safety in patients younger than 18 years have not been established.
When drugs are prepared from human blood or human plasma, certain measures are taken to prevent the transmission of infection to patients. These measures include careful selection of blood and plasma donors to ensure that those who carry the infection are excluded and that each donation and plasma pool is tested and examined so that there are no signs of viruses/infections. There are also steps in the manufacturing process of blood/plasma products where viruses are inactivated or removed. Despite these measures, the risk of infection can not be completely ruled out, when using medicinal products made from human blood or human plasma. This also applies to all unknown and new viruses as well as other types of infection er.
There are no reports of viral infections with albumin made according to European pharmacopeia specifications according to established processes.
It is strongly recommended that the product name and batch number be noted each time OPTISON is used, to have a record of the batch used.
Other medicines and OPTISON
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breastfeeding
The safety of OPTISON during pregnancy has not been fully established. Therefore, the preparation should be used during pregnancy only if the benefits outweigh the risks and if the treating physician considers use necessary. Because OPTISON is made from human albumin (the major protein in our blood), harmful effects on the fetus are highly unlikely.
There is no information on whether OPTISON is excreted in human milk. Therefore, OPTISON should be used with caution in breastfeeding women.
Driving and using machines
No known effects.
OPTISON contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’. it is largely “sodium-free”.
How to use OPTISON
OPTISON should only be used by physicians skilled in the field of cardiac diagnostics using ultrasound technology.
OPTISON is given as an intravenous injection to allow the microspheres to reach the heart and fill the left ventricle. OPTISON is injected during an ultrasound examination so that the doctor can assess the heart’s function.
The recommended dose is 0.5 ml – 3.0 ml per patient. A dose of 3.0 ml is usually sufficient, but some patients may need a higher dose. This dose can be repeated as needed. A dose of 0.5 – 3.0 ml OPTISON is sufficient for effective formation for 2.5 – 4.5 minutes.
Immediately after completion of the injection of OPTISON, 10 ml of sodium chloride 9 mg/ml solution for injection or glucose 50 mg/ml solution for injection is injected at a rate of 1 ml / s to optimize the effect of the contrast medium.
If you take more OPTISON than you should
No adverse reactions suspected of being due to overdose have been reported.
Possible side effects
Like all medicines, OPTISON can cause side effects, although not everybody gets them.
Side effects with OPTISON are rare and usually mild. In general, the administration of human albumin has been able to cause transient (short-term) taste changes, nausea, flushing, rash, headache, vomiting, chills, and fever. Preparations made from human albumin have in rare cases given rise to severe allergic reactions ( anaphylaxis ). Side effects reported after using OPTISON:
Common side effects (affects 1 to 10 users in 100):
- Dysgeusi (taste changes)
- Headache
- Blushing of the face
- Feeling of warmth
- Nausea
Uncommon side effects (affects 1 to 10 users in 1,000):
- Eosinophilia (increased number of a certain type of white blood cell)
- Dyspnoea (difficulty breathing)
- Chest pain
Rare side effects (affects 1 to 10 users in 10,000):
- Tinnitus (ringing or ringing in the ears)
- Dizziness
- Paresthesias (tingling or tingling)
- Ventricular tachycardia (rapid heartbeat)
Unknown frequency ( side effects where the frequency can not be estimated from the available data):
- Symptoms of allergic type, such as a severe allergic reaction or allergic shock ( anaphylaxis , facial swelling (facial edema), itchy skin rash ( urticaria ).
- Visual disturbances.
How to store OPTISON
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 after EXP. The expiration date is the last day of the specified month.
Store upright in a refrigerator (2ºC-8ºC).
Can be stored at room temperature (up to 25ºC) for 1 day.
Do not freeze.
The contents of the OPTISON bottle should be used within 30 minutes after perforating the rubber stopper.
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.
Contents of the package and other information
Content declaration
- The active substance is perflutrene-filled microspheres of heat-treated human albumin 5-8 x 10 8 / ml, suspended in a solution of 1% human albumin. One milliliter of OPTISON contains approximately 0.19 mg of perfluorine gas.
- The other ingredients are human albumin, N-acetyltryptophan, caprylic acid, sodium chloride, sodium hydroxide and water for injections.
What the medicine looks like and contents of the pack
OPTISON is a dispersion for injection. It is a clear solution with a white microsphere layer on top.
The product is supplied as 1 vial of 3 ml and 5 vials of 3 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
GE Healthcare AS
Nycoveien 1
NO-0485 OSLO, Norway
Contact the representative of the marketing authorization holder to find out more about this medicine:
GE Healthcare AB
Vendevägen 89
S-182 32 Danderyd
Tel: + 46 (0) 8 559 504 00