TISSEEL Ready to use solution for sealant 4ml pre-filled syringes

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Fibrinogen; Thrombin; Calcium chloride; Aprotinin

Tilgjengelig fra:

Baxter Healthcare Ltd

ATC-kode:

B02BC30

INN (International Name):

Fibrinogen; Thrombin; Calcium chloride; Aprotinin

Dosering :

91mg/1ml ; 500unit/1ml ; 40micromol/1ml ; 3000Kallikrein inactivator unit/1ml

Legemiddelform:

Solution for sealant

Administreringsrute:

Epilesional

Klasse:

No Controlled Drug Status

Resept typen:

Never Valid To Prescribe As A VMP

Produkt oppsummering:

BNF: ; GTIN: 05413760350059

Preparatomtale

OBJECT 1
TISSEEL READY TO USE SOLUTIONS FOR SEALANT
Summary of Product Characteristics Updated 01-Apr-2015 | Baxter
Healthcare Ltd
1. Name of the medicinal product
TISSEEL Ready to use
Solutions for Sealant
2. Qualitative and quantitative composition
Component 1:
Sealer Protein Solution
Human Fibrinogen (Clottable
Protein)
91 mg
(1)
/ml
Aprotinin (synthetic)
3000 KIU
(2)
/ml
Component 2:
Thrombin Solution
Human Thrombin
500 IU
(3)
/ml
Calcium Chloride
40 μmol/ml
1
Contained in a total protein concentration of 110.5 mg/ml
2
1 EPU (European Pharmacopoeia Unit) corresponds to 1800 KIU
(Kallidinogenase Inactivator Unit)
3
Thrombin activity is calculated using the current WHO International
Standard for Thrombin.
For excipients, see section 6.1.
1 prefilled double chamber syringe which contains Sealer Protein
Solution (with synthetic Aprotinin),
deep frozen 1 ml, 2 ml, or 5 ml, in one chamber and Thrombin Solution
(with Calcium Chloride), deep
frozen 1 ml, 2 ml, or 5 ml, in the other chamber results in 2 ml, 4
ml, or 10 ml total volume of product
ready for use.
3. Pharmaceutical form
Solutions for Sealant
Colourless to pale yellow and clear to slightly turbid solutions.
4. Clinical particulars
4.1 Therapeutic indications
Supportive treatment where standard surgical techniques are
insufficient
- for improvement of hemostasis (see section 5.1)
- as a tissue glue to promote adhesion/sealing, or as suture support:
- in gastrointestinal anastomoses
- in neurosurgery where contact with cerebro-spinal fluid or dura
mater may occur
- For mesh fixation in hernia repair, as an alternative or adjunct to
sutures or staples.
4.2 Posology and method of administration
The use of TISSEEL is restricted to experienced surgeons who have been
trained in the use of TISSEEL.
POSOLOGY
The amount of TISSEEL Ready to use to be applied and the frequency of
application should always be
oriented towards the underlying clinical needs for the patient.
The dose to be applied is governed by variables including, but not
limited to, the type of surgic