Human fibrinogen + human thrombin

Refrigerated Storage · New Medicines ·

319935004

Refrigerated Storage

Tisseel · Baxter

Baxter
Tisseel
Ready to use solution for sealant

The product literature states that the product should be stored in a freezer (at ≤-18°C) and the cold storage chain must not be interrupted until use. Once thawed, unopened pouches may be stored for up to 72 hours at controlled room temperature (not exceeding 25°C) after removal from the freezer. If not used within 72 hours after thawing, the product must be discarded.

Contact Baxter for additional information on cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

Thawed solutions should be given an expiry of 72 hours from when the product was removed from the freezer.
No
17th April 2019
London MI Service

New Medicines

VeraSeal · Haemorrhage in adults undergoing surgery

Information

VeraSeal
New formulation
Grifols

Development and Regulatory status

Licensed but not launched
Licensed but not launched
None
Nov 17 · Approved in EU [3].
Sep 17 · EU positive opinion for supportive treatment in adults where standard surgical techniques are insufficient: • for improvement of haemostasis. • as suture support in vascular surgery. It is proposed that the use of VeraSeal is restricted to experienced surgeons who have been trained in the use of the medicinal product [1].

Category

VeraSeal will be available as solutions containing the active substances human fibrinogen (80 mg/ml) and human thrombin (500 IU/ml).
Acute coagulopathy with significant blood loss is frequent in major vascular procedures. The problem is confounded by the high prevalence of antithrombotic agent use among patients undergoing vascular surgical procedures and intraoperative heparin administration [2].
Haemorrhage in adults undergoing surgery
Topical