Tisseel

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

Aprotinin 2250 kIU/mL - 3750 kIU/mL; Factor XIII 1.2 IU/mL - 10 IU/mL (in Total Protein solution); Fibrinogen 72 mg/mL - 110 mg/mL (in Total Protein solution); Calcium chloride dihydrate 0.036 mmol/mL - 0.044 mmol/mL; Thrombin 400 IU/mL - 625 IU/mL

제공처:

Baxter Healthcare Ltd

INN (국제 이름):

Aprotinin 2250 kIU - 3750 kIU

약제 형태:

Topical solution

구성:

Active: Aprotinin 2250 kIU/mL - 3750 kIU/mL Factor XIII 1.2 IU/mL - 10 IU/mL (in Total Protein solution) Fibrinogen 72 mg/mL - 110 mg/mL (in Total Protein solution) Excipient: Albumin Histidine as L-Histidine Nicotinamide Polysorbate 80 Sodium citrate Water for injection Active: Calcium chloride dihydrate 0.036 mmol/mL - 0.044 mmol/mL Thrombin 400 IU/mL - 625 IU/mL Excipient: Albumin Sodium chloride Water for injection

패키지 단위:

Combination pack, AST double-chamber pre-filled syringes 1mL + 1mL, 2 mL

수업:

Prescription

처방전 유형:

Prescription

Manufactured by:

Bachem AG

치료 징후:

As adjunct to haemostasis during surgical procedures, when control of bleeding by conventional surgical techniques is ineffective or impractical

제품 요약:

Package - Contents - Shelf Life: Combination pack, PRIMA double-chamber pre-filled syringes 1mL + 1mL - 2 mL - 24 months from date of manufacture stored at or below -18°C 96 hours not refrigerated stored at or below 25°C. thawed, or 24 hours at 33 to 37 deg C - Combination pack, AST double-chamber pre-filled syringes 1mL + 1mL - 2 mL - 24 months from date of manufacture stored at or below -18°C 72 hours not refrigerated stored at or below 25°C. thawed, or 12 hours at 33 to 37 deg C - Combination pack, PRIMA double-chamber pre-filled syringe 2mL + 2mL - 4 mL - 24 months from date of manufacture stored at or below -18°C 96 hours not refrigerated stored at or below 25°C. (thawed), or 24 hours at 33 to 37 deg C - Combination pack, AST double-chamber pre-filled syringe 2mL + 2mL - 4 mL - 24 months from date of manufacture stored at or below -18°C 72 hours not refrigerated stored at or below 25°C. (thawed), or 12 hours at 33 to 37 deg C - Combination pack, AST double-chamber pre-filled syringe 5mL + 5mL - 10 mL - 24 months from date of manufacture stored at or below -18°C 72 hours not refrigerated stored at or below 25°C. (thawed) or 12 hours at 33 to 37 deg C - Combination pack, PRIMA double-chamber pre-filled syringe 5mL + 5mL - 10 mL - 24 months from date of manufacture stored at or below -18°C 96 hours not refrigerated stored at or below 25°C. (thawed) or 24 hours at 33 to 37 deg C

승인 날짜:

2004-04-02

환자 정보 전단

CONSUMER MEDICINE INFORMATION
TISSEEL DUO 500
_TWO-COMPONENT FIBRIN SEALANT, _
_DEEP-FROZEN _
WHAT IS IN THIS LEAFLET?
This leaflet answers some common questions about the TISSSEEL DUO 500,
TWO-
COMPONENT FIBRIN SEALANT, DEEP FROZEN [TISSEEL DUO 500]. It does not
contain all
of the available information. All medicines have risks and benefits.
Your doctor has
weighed the risks against the benefits for you by using TISSEEL DUO
500.
It does not take the place of talking to your doctor or pharmacist. If
you have any
concerns about having this medicine, ask your doctor or pharmacist.
WHAT TISSEEL DUO 500 IS USED FOR?
TISSEEL DUO 500 is used to help stop excessive blood loss during
surgery by inducing
clotting. This clot has also sealing properties. Thus, it can also be
used as an aid to help
in the closure of colostomies.
HOW DOES TISSEEL DUO 500 WORK?
The blood coagulation factors in the composition of TISSEEL DUO 500
are the same to
those found in the normal healthy individuals. They are isolated from
healthy human
plasma, except aprotinin which is isolated from cow's lung (bovine).
The components
are packed in two separate syringes. One of the syringes contains
Sealer Protein
Solution while the others contain Thrombin Solution. Both syringes are
stored in a deep
frozen state. They will be warmed up to 37°C just prior to use.
BEFORE YOU ARE GIVEN THE TISSEEL DUO 500
TISSEEL DUO 500 SHOULD NOT BE GIVEN TO YOU IF:

you have a tendency for allergic reaction or hypersensitivity to
aprotinin. Some of
the symptoms of an allergic reaction may include skin rash, swelling
of the face,
lips or tongue, which may cause difficulty swallowing or shortness of
breath.

the expiry date printed on the pack has past.
YOU MUST TELL YOUR DOCTOR IF YOU:

have any other illness

are taking any prescription medicine or any other medicines purchased
from a
pharmacy, health food store or supermarket

have previously received aprotinin or fibrin sealant, whether you are
allergic to it
or not.
YOU MUST TELL YOUR DOCTOR IF YOU A

제품 특성 요약

NEW ZEALAND DATA SHEET
TISSEEL Data Sheet 7 May 2019
Page 1 of 18
Baxter Healthcare Ltd
1 TISSEEL (topical solution)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Aprotinin (synthetic), factor XIII, fibrinogen, thrombin and calcium
chloride dihydrate.
The active ingredients of TISSEEL VH S/D are formulated as two
sterile, deep‐frozen solutions; the
Sealer Protein Solution and Thrombin Solution (see Table below for
composition of TISSEEL). Each
solution is presented in a separate preloaded chamber of one
double‐chamber syringe.
_Biological origin of active substance _
The active ingredients are fractionated from pooled human plasma.
_Composition of TISSEEL _
List of active ingredients and associated quantities
Sealer Protein solution
Quantity
Thrombin Solution
Quantity
Aprotinin, synthetic
2250 ‐ 3750KIU/mL
Thrombin (human)
400 ‐ 625IU/mL
Factor XIII
1.2 ‐ 10IU/mL
Calcium chloride
dihydrate
36 ‐ 44micromol/mL
Fibrinogen
72 ‐ 110mg/mL
For the full list of excipients see section 6.1
The two deep frozen solutions comprising TISSEEL must be defrosted
prior to use. After thawing and
warming up to 37ºC, the two solutions are mixed during application
(see section 4.2/Method of
Application).
3 PHARMACEUTICAL FORM
Topical solution.
Two‐component Fibrin Sealant, Deep‐Frozen, Vapour Heated (VH) and
Solvent Detergent (S/D)
treated, TISSEEL VH S/D
1
.
_Appearance _
The two components of TISSEEL are colourless to pale yellow,
opalescent when frozen and clear to
slightly turbid solutions once defrosted.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
TISSEEL is indicated:

as adjunct to haemostasis during surgical procedures, when control of
bleeding by
conventional surgical techniques is ineffective or impractical

as a sealant as an adjunct for closure of colostomies

as a sealant and/or adhesive for use in autologous chondrocyte
implantation (ACI) or
matrix‐induced autologous chondrocyte implantation (MACI) procedures

for mesh fixation in inguinal, femoral and incisional hernia repair,
as an