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319935004

Refrigerated Storage

TisseelBaxter Healthcare Ltd

Baxter Healthcare Ltd
Tisseel
Ready to use solution for sealant

In the event of an inadvertent temperature excursion the following data may be used:
Minimum temperature 
The storage temperature should not be lower than minus 25°C for Tisseel. Baxter Healthcare Ltd has not tested the impact storage temperatures below minus 25°C may have on Tisseel. There is no information on how extreme low temperatures may impact the product or its components, including the packaging.

Maximum temperature 
In case of a short term excursion of the intended storage or transport temperature, in-house stability data shows that there is no impact to the product quality or performance when exposed to a temperature excursion of not more than minus 15°C.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk
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.

Information not provided by manufacturer
Information not provided by manufacturer
11 March 2021
London MI Service

New Medicines

VeraSealHaemorrhage in adults undergoing surgery

Information

VeraSeal
New formulation
Grifols
Not Known

Development and Regulatory status

Launched
Launched
None
October 2020
Oct 20Launched in EU. The product is available in 2 sizes: 4ml (2ml syringe of human Fibrinogen/2ml syringe of Human Thrombin) £172.66 and 10ml (5ml syringe of human Fibrinogen/5ml syringe of Human Thrombin) £389.89 [4].
Nov 17Approved in EU [3].
Sep 17EU 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

Evidence based evaluations