Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - veraseal

Document Subject

Generated Narrative: MedicinalProductDefinition mp41399424be0ac355c8e0aa81bb4121d6

identifier: http://ema.europa.eu/identifier/EU/1/17/1239/001-004

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: VeraSeal solutions for sealant

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-41399424be0ac355c8e0aa81bb4121d6

identifier: http://ema.europa.eu/identifier/EU/1/17/1239/001-004

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - veraseal

Attesters

What is in this leaflet

1. What VeraSeal is and what it is used for
2. What you need to know before you are treated with VeraSeal
3. How VeraSeal is used
4. Possible side effects
5. How VeraSeal is stored
6. Contents of the pack and other information

VeraSeal contains human fibrinogen and human thrombin, two proteins extracted from the blood that form a clot when they are mixed together.

VeraSeal is used as a sealant during surgical operations in adults. It is applied to the surface of bleeding tissue to reduce bleeding during and after the operation when standard surgical techniques are not sufficient.

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 rapid bleeding from an artery.

Warnings and precautions

Allergic reactions are possible. Signs of such reactions include hives, rash, tightness of the chest, wheezing, drop in blood pressure (e.g. light-headedness, fainting, blurred vision), and anaphylaxis (a severe reaction with a rapid onset). If these symptoms occur during surgery, the use of the medicine should be stopped immediately.

VeraSeal spray application should only be used if it is possible to accurately judge the spray distance. The spray device should not be used closer than the recommended distance.
Special safety warning

For medicines such as VeraSeal that are made from human blood or plasma, certain measures are taken to prevent infections being passed on to patients. These include carefully selecting blood and plasma donors to make sure those at risk of carrying infections are excluded, and testing each donation and pooled plasma for signs of virus/infections. Manufacturers also include steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections.

The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus. The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection may be serious for pregnant women (fetal infection) and for individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia).

It is strongly recommended that every time you are treated with VeraSeal, the name and batch number of the medicine are recorded in order to maintain a record of the batches used.

Children and adolescents

VeraSeal is not recommended for use in children and adolescents under 18 years of age.

Other medicines and VeraSeal

The product may be affected after contacting solutions containing alcohol, iodine or heavy metals (e.g. antiseptic solutions).

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being treated with this medicine. Your doctor will decide whether you should be treated with VeraSeal.

The use of VeraSeal is restricted to experienced surgeons who have been trained in the use of VeraSeal.

The surgeon will apply VeraSeal to the surface of blood vessels or to the tissue surface of internal organs using an application device during the course of the operation. This device allows equal amounts of the two components of VeraSeal to be administered at the same time, and ensures that they mix evenly, which is important for the sealant to work at its best.

The amount of VeraSeal that will be applied depends on a number of factors, including the type of surgery, the size of the area to be treated during your operation and the way VeraSeal is applied. The surgeon will decide how much is appropriate, and will apply just enough to form a thin, even layer. If it does not seem to be enough, a second layer can be applied.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

VeraSeal contains the component of fibrin sealant. Fibrin sealants may, in rare cases (up to 1 in 1,000 people), cause an allergic reaction. If you experience an allergic reaction you might have one or more of the following symptoms: swelling under skin (angioedema), skin rash, hives or wheals (nettle-rash), tightness of the chest, chills, flushing, headache, low blood pressure, lethargy, nausea, restlessness, heart rate increase, tingling, vomiting or wheezing. In isolated cases, these reactions may progress to a severe allergic reaction. Allergic reactions may especially be seen if the preparation is applied repeatedly, or administered to patients known to be allergic to constituents of the product. If you experience any of these symptoms after surgery, you should immediately consult your doctor or surgeon.

There is also a theoretical possibility that your immune system will produce proteins to attack VeraSeal and, that these may interfere with your blood clotting. The frequency of this type of event is not known.

If this product is accidentally placed inside a blood vessel, it can lead to blood clots, including disseminated intravascular coagulation (DIC) (when blood clots form throughout the blood vessels in the body). There is also a risk of a severe allergic reaction.

Side effects which were reported during clinical trials with VeraSeal included:

Most serious side effects

Uncommon (may affect up to 1 in 100 people):

• Abdominal (belly) abscess (swollen area in abdomen caused by infection)
• Abdominal (belly) wound dehiscence (wound breakdown due to incomplete healing)
• Leak of bile (a liquid produced by the liver) after the procedure
• Cellulitis (infection of the skin)
• Deep vein thrombosis (blood clots in the blood vessels)
• Liver abscess (swollen area in the liver caused by infection)
• Peritonitis (inflammation of the wall of the abdomen)
• Positive parvovirus B19 test (laboratory result showing infection with the virus)
• Postoperative wound infection
• Pulmonary embolism (blood clots in blood vessels in the lungs)
• Wound infection

Other side effects

Common (may affect up to 1 in 10 people):

• Nausea
• Pain caused by the surgery
• Pruritus (itching)

Uncommon (may affect up to 1 in 100 people):

• Anaemia (insufficiency of red blood cells)
• Anxiety
• Atrial fibrillation (irregular heartbeat)
• Back pain
• Bladder spasm
• Chills
• Conjunctival irritation (eye irritation)
• Constipation
• Contusion (bruise)
• Decreased urine output (reduced urine production)
• Dyspnoea (difficulty in breathing)
• Dysuria (pain or difficulty in urination)
• Ecchymosis (bruising)
• Erythema (reddening of the skin)
• Flatulence
• Headache
• High body temperature
• High or low blood pressure
• High or low levels of white cells in blood
• High potassium levels in blood
• Ileus (obstruction of the intestine)
• Impaired coagulation of blood
• Incision site erythema (reddening of the skin at the incision site)
• Incision site infection
• Increased blood bilirubin
• Increased levels of liver enzymes
• Increased or decreased glucose levels in blood
• Insomnia
• Low blood pressure due to the procedure
• Low calcium levels in blood
• Low magnesium levels in blood
• Low oxygen in blood
• Low potassium levels in blood
• Low protein levels in blood
• Low red blood cell levels caused by blood loss
• Low sodium levels in blood
• Oedema peripheral (accumulation of fluid)
• Pain, not specified
• Pain at the incision site
• Pain in extremity
• Plasma cell myeloma (cancer of blood cells)
• Pleural effusion (abnormal amount of fluid around the lung)
• Pleurisy (inflammation of lungs wall)
• Post procedural haemorrhage (bleeding after the procedure)
• Post procedural infection (infection after the procedure)
• Pulmonary oedema (excess of watery fluid in lungs)
• Retroperitoneal haematoma (accumulation of blood in the abdomen)
• Rhonchi (rattling lung sounds)
• Sleepiness
• Urinary retention
• Vascular graft complication (complication of vessel bypass)
• Vascular graft thrombosis (blood clots in blood vessel bypass)
• Ventricular tachycardia (rapid heartbeats)
• Vessel puncture site haematoma (bruising at site of vessel puncture)
• Vomiting
• Wheezing
• Wound secretion

Reporting of side effects If you get any side effects, talk to your doctor or surgeon. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

VeraSeal must be kept out of the sight and reach of children.

This medicine must not be used after the expiry date which is stated on the label and carton after EXP.

It must be stored and transported frozen at -18 C or colder. The cold storage chain must not be interrupted until use. Keep the sterilized blister in the outer carton in order to protect from light. Thaw completely before use. Do not refreeze once thawed. After thawing, it can be maintained not more than 7 days at 2 C - 8 C or 24 hours not above 25 C before use.

Once the blister is opened, VeraSeal should be used immediately.

It must not be used if the solutions are cloudy or have deposits.

Discard if the package is damaged.

What VeraSeal contains

The active substances are:

• Component 1: Human fibrinogen
• Component 2: Human thrombin

The other ingredients are:

• Component 1: Sodium citrate dihydrated, sodium chloride, arginine, isoleucine, glutamic acid monosodium, water for injections.
• Component 2: Calcium chloride, human albumin, sodium chloride, glycine, water for injections.

What VeraSeal looks like and contents of the pack

VeraSeal is presented as solutions for sealant. It is supplied as a single-use kit containing two pre-filled syringes assembled in a syringe holder. Frozen solutions. After thawing the solutions are clear or slightly opalescent and colourless or pale yellow.

One Dual Applicator with two additional Airless Spray Tips is supplied with the product, for application by spraying or dripping. The Airless Spray Tips are radiopaque. See scheme below.

VeraSeal is available in the following pack sizes:

• VeraSeal 2 ml (containing 1 ml of human fibrinogen and 1 ml of human thrombin)
• VeraSeal 4 ml (containing 2 ml of human fibrinogen and 2 ml of human thrombin)
• VeraSeal 6 ml (containing 3 ml of human fibrinogen and 3 ml of human thrombin)
• VeraSeal 10 ml (containing 5 ml of human fibrinogen and 5 ml of human thrombin)

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Instituto Grifols, S.A. Can Guasc, 2 - Parets del Vall s E-08150 Barcelona - Spain

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

AT/BE/BG/CY/EE/EL/HR/HU/IE/LV/ LT/LU/MT/NL/RO/SI/SK/UK(NI) Instituto Grifols, S.A. Tel: +34 93 571 01 CZ Grifols S.R.O. Tel: +4202 2223 1DE Grifols Deutschland GmbH Tel: +49 69 660 593 DK/FI/IS/NO/SE Grifols Nordic AB Tel: +46 8 441 89 ES Johnson & Johnson, S.A. Tel: +34 91 722 80 FR Johnson & Johnson Medical S.A.S. T l: +33 (0)1 55 00 22 IT Grifols Italia S.p.A. Tel: +39 050 8755 PL Grifols Polska Sp. z o. o. Tel: +48 22 378 85 PT Grifols Portugal, Lda. Tel: +351 219 255 This leaflet was last revised in.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: