VERASEAL Solutions for sealant Ref.[28242] Active ingredients: Human fibrinogen Thrombin

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Instituto Grifols, S.A., Can Guasc, 2 Parets del Vallès, E-08150 Barcelona Spain

Product name and form

VeraSeal solutions for sealant.

Pharmaceutical Form

Solutions for sealant.

Frozen solutions. After thawing, the solutions are clear or slightly opalescent and colourless or pale yellow.

Qualitative and quantitative composition

Component 1: Human fibrinogen 80 mg/ml.

Component 2: Human thrombin 500 IU/ml.

Produced from the plasma of human donors.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Human fibrinogen

Human fibrinogen (coagulation factor I), in the presence of thrombin, activated coagulation factor XIII (F XIIIa) and calcium ions is converted into a stable and elastic three-dimensional fibrin haemostatic clot. The administration of human fibrinogen concentrate provides an increase in plasma fibrinogen level and can temporarily correct the coagulation defect of patients with fibrinogen deficiency.
Thrombin
List of Excipients

Human fibrinogen syringe:

Sodium citrate dihydrated
Sodium chloride
Arginine
Isoleucine
Glutamic acid monosodium
Water for injections

Human thrombin syringe:

Calcium chloride
Human albumin
Sodium chloride
Glycine
Water for injections

Pack sizes and marketing

VeraSeal is supplied as a single-use kit containing two pre-filled syringes (glass type I) with rubber stoppers, each with a sterile frozen solution, assembled in a syringe holder.

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 authorization holder

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

Marketing authorization dates and numbers

EU/1/17/1239/001-004

Date of first authorisation: 10 November 2017

Drugs

Drug Countries
VERASEAL Austria, Estonia, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom
 
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