TISSEEL FIBRIN SEALANT VH SD (FROZEN)

Country: Սինգապուր

language: անգլերեն

source: HSA (Health Sciences Authority)

active_ingredient:

Aprotinin (synthetic) (for sealer protein solution); Calcium chloride (for thrombin solution); Fibrinogen (clottable protein) (for sealer protein solution); Thrombin (for thrombin solution)

MAH:

BAXTER HEALTHCARE (ASIA) PTE LTD

ATC_code:

B02BC, V03AK

pharmaceutical_form:

SOLUTION

composition:

Aprotinin (synthetic) (for sealer protein solution) 2250-3750 KIU/ml; Calcium chloride (for thrombin solution) 36-44 umol/ml; Fibrinogen (clottable protein) (for sealer protein solution) 72-110 mg/ml; Thrombin (for thrombin solution) 400-625 IU/ml

administration_route:

TOPICAL

prescription_type:

Prescription Only

manufactured_by:

Takeda Manufacturing Austria AG (Site: Industriestrasse 72)

authorization_status:

ACTIVE

authorization_date:

2014-12-22

PIL

Technical Info
Dieline
NA
NA
NA
CODE 3 OF 9
DATAMATRIX CODE
RSS / GS1-128 CODE
BODY TEXT SIZE
8.4 pt
746769
CODE ITF 2/5
NA
PHARMACODE
NA
GTIN / EAN-13 CODE
BACK
PANTONE 287 U
TECHNICAL SPECIFICATION:
ARTWORK DIMENSIONS/SIZE:
ITEM NUMBER:
FRONT
0746769
VERSION: 2.0
PROFILE: 0402126_1_PIL_Drwg
0402126
630 x 293 mm
GRAPHICS HOUSE:
SGK Redmond / Cathy Cole
DATE:
01AUG2019
OPTIONAL: Artwork Approver outside the Shire Management System:
ROLE:
NAME:
SIGNATURE:
DATE:
Swatch
Swatch
Swatch
PANTONE 287 U
Swatch
Swatch
Swatch
1.
NAME OF THE MEDICINAL PRODUCT
TISSEEL Fibrin Sealant VH S/D (frozen)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Component 1: Sealer protein solution
Human fibrinogen (as clottable protein)
91 mg
1
/ml
Aprotinin (synthetic)
3000 KIU
2
/ml
Excipients:
Polysorbate 80
0.6 – 1.9 mg/ml
Component 2: Thrombin solution
Human thrombin
500 IU
3
/ml
Calcium chloride
40 μmol/ml
1, 2 or 5 ml deep frozen sealer protein solution (with synthetic
aprotinin) and
1, 2 or 5 ml deep frozen thrombin solution (with calcium chloride)
combine to make
2, 4 or 10 ml ready- to-use fibrin sealant solution.
After mixing
1 ml
2 ml
4 ml
10 ml
Component 1:
Sealer protein solution
Human fibrinogen
(as clottable protein)
Synthetic Aprotinin
45.5 mg
1500 KIU
91mg
3000 KIU
182 mg
6000 KIU
455 mg
15000 KIU
Component 2:
Thrombin solution
Human thrombin
Calcium chloride
250 IU
20 μmol
500 IU
40 μmol
1000 IU
80 μmol
2500 IU
200 μmol
TISSEEL contains Human Factor XIII co-purified with Human Fibrinogen
in a range
of 0.6 – 5 IU/ml.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solutions for sealant
Deep frozen
When deep frozen: colorless to pale yellow, opalescent frozen
solutions;
After thawing: colorless to pale yellow liquids.
4.
CLINICAL PARTICULARS
4.1 Therapeutic indications
Supportive
treatment
where
standard
surgical
techniques
appear
insufficient
(see section 5.1)
•
For improvement of hemostasis
•
As a tissue glue to improve wound healing or to support sutures in
vascular
surgery and in gastroint

SPC

Technical Info
Dieline
NA
NA
NA
CODE 3 OF 9
DATAMATRIX CODE
RSS / GS1-128 CODE
BODY TEXT SIZE
8.4 pt
758200
CODE ITF 2/5
NA
PHARMACODE
NA
GTIN / EAN-13 CODE
BACK
PANTONE 287 U
TECHNICAL SPECIFICATION:
ARTWORK DIMENSIONS/SIZE:
ITEM NUMBER:
FRONT
0758200
VERSION: 2
PROFILE: 0402126_1_PIL_Drwg
0402126
630 x 293 mm
GRAPHICS HOUSE:
SGK Redmond
DATE:
04AUG2022
OPTIONAL: Artwork Approver outside the Shire Management System:
ROLE:
NAME:
SIGNATURE:
DATE:
Swatch
Swatch
Swatch
PANTONE 287 U
Swatch
Swatch
Swatch
1.
NAME OF THE MEDICINAL PRODUCT
TISSEEL Fibrin Sealant VH S/D (frozen)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Component 1: Sealer protein solution
Human fibrinogen (as clottable protein)
91 mg
1
/ml
Aprotinin (synthetic)
3000 KIU
2
/ml
Excipients:
Polysorbate 80
0.6 – 1.9 mg/ml
Component 2: Thrombin solution
Human thrombin
500 IU
3
/ml
Calcium chloride
40 μmol/ml
1, 2 or 5 ml deep frozen sealer protein solution (with synthetic
aprotinin) and
1, 2 or 5 ml deep frozen thrombin solution (with calcium chloride)
combine to make
2, 4 or 10 ml ready-to-use fibrin sealant solution.
After mixing
1 ml
2 ml
4 ml
10 ml
Component 1:
Sealer protein solution
Human fibrinogen
(as clottable protein)
Synthetic Aprotinin
45.5 mg
1500 KIU
91mg
3000 KIU
182 mg
6000 KIU
455 mg
15000 KIU
Component 2:
Thrombin solution
Human thrombin
Calcium chloride
250 IU
20 μmol
500 IU
40 μmol
1000 IU
80 μmol
2500 IU
200 μmol
TISSEEL contains Human Factor XIII co-purified with Human Fibrinogen
in a range of
0.6 - 5 IU/ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solutions for sealant
Deep frozen
When
deep
frozen:
colorless
to
pale
yellow,
opalescent
frozen
solutions;
After thawing: they are colorless to pale yellow.
4.
CLINICAL PARTICULARS
4.1 Therapeutic indications
Supportive treatment where standard surgical techniques appear
insufficient (see
section 5.1)
•
For improvement of hemostasis
•
As a tissue glue to improve wound healing or to support sutures in
vascular
surgery and in gastrointestinal anastom