solutions for tissue adhesives
human fibrinogen/human thrombin
What VeraSeal is and what it is used for
VeraSeal contains human fibrinogen and human thrombin, two proteins taken from the blood that form a clot (the blood clots) when mixed.
VeraSeal is used as a tissue adhesive during surgical procedures on adults. It is applied to the surface of the bleeding tissue to reduce bleeding during and after surgery when standard surgical techniques are not enough.
What you need to know before being treated with Veraseal
Your surgeon must not treat you with VeraSeal:
- if you are allergic to human fibrinogen or human thrombin or any of the other ingredients of this medicine (listed in section 6).
VeraSeal must not be applied inside blood vessels.
VeraSeal must not be used to treat severe or profuse bleeding from an artery.
Warnings and precautions
Allergic reactions may occur. Signs of such reactions may include hives, skin rash, chest tightness, wheezing, low blood pressure (which can cause dizziness, fainting, and blurred vision), and anaphylaxis (a serious reaction that comes on suddenly). If such symptoms occur during an operation, the drug should be stopped immediately.
The spray application of VeraSeal should only be used if it is possible to correctly judge the spray distance. The spray unit must not be used closer to tissue than the recommended distance.
Special safety warning
In the case of medicines such as VeraSeal that are made from blood or blood plasma that has been donated from humans, certain measures are taken to prevent the transmission of infection to the patients. This means, for example, that blood and plasma donors are carefully selected to ensure that no donors carry any infection and that both each donation and all collected plasma are tested to see that there are no signs of viruses/infections. Manufacturers also take various measures when preparing blood and plasma that can inactivate or remove viruses. Despite these measures, the risk of transmission of infectious agents cannot be completely ruled out when using medicines that have been made from human blood or human plasma. This also applies to unknown or new viruses or other types of infection.
The measures taken are considered effective against enveloped viruses, such as human immunodeficiency virus ( HIV ), hepatitis B virus, hepatitis C virus, and the non-enveloped hepatitis A virus et. The measures taken may be of limited value against non-enveloped viruses, such as parvovirus B19. Infection with parvovirus B19 can be serious for pregnant women (fetal infection) and for people who have a weakened immune system or who have certain types of anemia ( blood deficiency ) (eg sickle cell disease or hemolytic anemia).
Each time you are treated with VeraSeal, we strongly recommend that you record the drug name and batch number to create a record of which batches have been used.
Children and young people
VeraSeal is not recommended for children and adolescents under 18 years of age.
Other medicines and VeraSeal
The medicine can be affected by contact with solutions containing alcohol, iodine, or heavy metals (eg antiseptic solutions).
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before being treated with this medicine. The doctor will decide if you can be treated with VeraSeal.
How VeraSeals are used
VeraSeal should only be used by specialist doctors who have received training in how to use VeraSeal.
During the operation, the surgeon applies a VeraSeal to the surface of various blood vessels or the tissue surface of internal organs using an applicator. The applicator allows you to add an equal amount of the two components of VeraSeal at the same time and ensures that they are evenly mixed, which is important for the tissue adhesive to work as well as possible.
The amount of VeraSeal that is applied depends on several different factors, e.g. the type of operation, how large an area is treated during the operation, and how VeraSeal is applied. A surgeon decides how much is appropriate, and applies just enough to form a thin, even layer. If it doesn’t seem to be enough, the surgeon can apply another layer.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
VeraSeal contains the components needed for fibrin glue. Fibrin glue can rarely (in up to 1 in 1,000 users) cause an allergic reaction. If you have an allergic reaction, you may have one or more of the following symptoms: swelling under the skin ( angioedema ), rash, hives or urticaria ( hives ), chest tightness, chills, flushing, headache, low blood pressure, lethargy (extreme tiredness/ drowsiness), nausea, restlessness, increased heart rate, tingling, vomiting or wheezing. In rare cases, these reactions have developed into severe allergic reactions. Such reactions can occur in particular if the medicine is applied repeatedly or is used in patients who are known to be allergic to the ingredients in the product. If you get any of these symptoms after the operation, you should immediately contact your doctor or surgeon.
There is also a theoretical risk that your immune system develops antibodies against the proteins in VeraSeal, which can interfere with the blood’s ability to coagulate. It is not known how often this occurs.
If the medicine is accidentally applied to a blood vessel, it can lead to blood clots and disseminated intravascular coagulation ( DIC ) (when blood clots form in all the blood vessels of the body). There is also a risk of a serious allergic reaction.
Side effects reported during clinical trials with VeraSeal were:
The most serious side effects
Uncommon (may affect up to 1 in 100 users):
- an abdominal abscess (swollen area in the abdomen caused by infection)
- Abdominal wound rupture (the wound ruptures due to incomplete healing)
- leakage of bile (a fluid produced in the liver) after surgery
- cellulitis ( infection of the skin)
- deep vein thrombosis (clots in the blood vessels)
- a liver abscess (swollen area of the liver caused by infection)
- peritonitis ( inflammation of the peritoneum)
- positive test for parvovirus B19 (laboratory tests show infection with the virus)
- wound infection after surgery
- pulmonary embolism (blood clots in the vessels of the lungs)
- wound infection.
Other side effects are
Common (may affect up to 1 in 10 users):
- nausea
- pain due to surgery
- itching.
Uncommon (may affect up to 1 in 100 users):
- anemia ( lack of blood, i.e. lack of red blood cells)
- anxiety concern
- atrial fibrillation (irregular heartbeat)
- back pain
- bladder spasm
- overindulge
- conjunctival irritation (eye irritation)
- constipation
- bruise after injury
- decreased urine production
- dyspnea (difficulty breathing)
- pain when urinating or difficulty urinating
- bruise on the skin
- erythema (redness of the skin)
- intestinal gases
- headache
- fever
- high or low blood pressure
- high or low levels of white blood cells in the blood
- high potassium levels in the blood
- ileus (intestine blockage)
- impaired blood coagulation
- skin redness at the site of the procedure
- infection at the site of the procedure
- increased bilirubin content in the blood
- the increased amount of liver enzymes
- increased or decreased amount of glucose in the blood (blood sugar)
- sleeping problems
- low blood pressure due to the procedure
- low calcium in the blood
- low level of magnesium in the blood
- low oxygen content in the blood
- low level of potassium in the blood
- low protein content in the blood
- low red blood cell count due to blood loss
- low blood sodium
- fluid accumulation in the legs and feet
- pain, unspecified
- pain at the site of the procedure
- pain in arms and legs
- plasma cell myeloma (cancer of blood cells)
- abnormal amount of fluid around the lungs
- pleurisy
- bleeding after surgery
- infection after surgery
- pulmonary edema (abnormal amount of fluid in the lungs)
- accumulation of blood in the abdomen
- Ronchi (abnormal breath sounds)
- somnolence
- urinary retention (difficulty emptying the bladder)
- the complication in the vascular graft (complication in bypass vessel)
- thrombosis in the vascular graft (blood clots in bypass vessels)
- rapid heartbeat
- bruise on the puncture site
- vomiting
- wheezing
- oozing wounds.
How to store VeraSeal
VeraSeal must be stored out of the sight and reach of children.
This medicine must be used before the expiry date which is stated on the label and the carton after EXP.
The medicine must be stored in a deep-frozen state at -18 °C or colder. The frying chain must not be broken before use. Store the sterilized blister in the outer carton. Light sensitive. Allow the solution to thaw completely before use. Do not refreeze after thawing. After thawing, the medicine can be stored for a maximum of 48 hours at 2-8 °C or 24 hours at room temperature (20-25 °C) before use.
Once the blister has been opened, VeraSeal should be used immediately.
The medicine must not be used if the solutions are cloudy or contain particles.
Discard the product if the packaging is damaged.
Contents of the packaging and other information
Contents declaration
The active substances are:
- Component 1: human fibrinogen
- Component 2: human thrombin
Other ingredients are:
- Component 1: sodium citrate dihydrate, sodium chloride, arginine, isoleucine, glutamic acid, monosodium, and water for injections.
- Component 2: calcium chloride, human albumin, sodium chloride, glycine, and water for injections.
Appearance and package sizes of the medicine
The preparation form for VeraSeal is solution for tissue glue. It is supplied as a single-use kit with two pre-filled syringes mounted in a syringe holder. The solutions are frozen. After thawing, the solutions are clear or slightly opalescent and colorless or pale yellow.
A double applicator with two additional airless spray tips is included with the product, which can be applied as a spray or drops. The airless spray tips are radiopaque. See the illustration below.
VeraSeal is available in the following pack sizes:
- VeraSeal 2 ml (1 ml human fibrinogen and 1 ml human thrombin)
- VeraSeal 4 ml (2 ml human fibrinogen and 2 ml human thrombin)
- VeraSeal 6 ml (3 ml human fibrinogen and 3 ml human thrombin)
- VeraSeal 10 ml (5 ml human fibrinogen and 5 ml human thrombin)
Not all pack sizes may be marketed.
Instituto Grifols, SA
Can Guasc, 2 – Parets del Vallès E-08150 Barcelona
Spain
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
| AT/BE/BG/CY/EE/EL/ES/HR/HU/IE/LV/ LT/LU/MT/NL/RO/SI/SKInstituto Grifols, SA Tel: +34 93 571 01 00 | CZGrifols SROPhone: +4202 2223 1415 |
| THEGrifols Deutschland GmbH Tel: +49 69 660 593 100 | DK/FI/IS/NO/SEGrifols Nordic AB Tel: +46 8 441 89 50 |
| FRJohnson & Johnson Medical SAS Tel: +33 (0)1 55 00 22 33 | ITGrifols Italia SpA Tel: +39 050 8755 113 |
| PLGrifols Polska Sp. z o. o. Phone: +48 22 378 85 60 | PTGrifols Portugal, Lda. Phone: +351 219 255 200 |
| UKGrifols UK Ltd.Phone: +44 845 2413090 |