ARTISS solution for sealant 4ml pre-filled syringes

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Aprotinin; Thrombin; Calcium chloride; Fibrinogen

Предлага се от:

Baxter Healthcare Ltd

АТС код:

B02BC30

INN (Международно Name):

Aprotinin; Thrombin; Calcium chloride; Fibrinogen

дозиране:

1500Kallikrein inactivator unit/1ml ; 2unit/1ml ; 20micromol/1ml ; 45.5mg/1ml

Лекарствена форма:

Solution for sealant

Начин на приложение:

Epilesional

Клас:

No Controlled Drug Status

Вид предписание :

Never Valid To Prescribe As A VMP

Каталог на резюме:

BNF: ; GTIN: 05413760362465

Данни за продукта

OBJECT 1
ARTISS SOLUTIONS FOR SEALANT
Summary of Product Characteristics Updated 18-Nov-2015 | Baxter
Healthcare Ltd
1. Name of the medicinal product
ARTISS Solutions for Sealant
Deep frozen
2. Qualitative and quantitative composition
Component 1:
Sealer Protein Solution
Human Fibrinogen (as clottable protein)
Aprotinin (synthetic)
91 mg
1
/ml
3000 KIU
2
/ml
Component 2:
Thrombin Solution
Human Thrombin
Calcium Chloride
4 IU
3
/ml
40 μmol/ml
1 prefilled double chamber syringe which contains Sealer Protein
Solution (with Aprotinin), deep frozen
<1 ml><2 ml><5 ml>, in one chamber and Thrombin Solution (with Calcium
Chloride), deep frozen<1
ml><2 ml><5 ml>, in the other chamber results in <2 ml><4 ml><10 ml>
total volume of product ready
for use.
After mixing
1 ml
2 ml
4 ml
10 ml
Component 1: Sealer protein solution
Human Fibrinogen (as clottable
protein)
Aprotinin (synthetic)
45.5 mg
1,500 KIU
91 mg
3,000 KIU
182 mg
6,000 KIU
455 mg
15,000 KIU
Component 2: Thrombin Solution
Human Thrombin
Calcium Chloride
2 IU
20 μmol
4 IU
40 μmol
8 IU
80 μmol
20 IU
200 μmol
ARTISS 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.
1
Contained in a total protein concentration of 96 - 125 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.
3. Pharmaceutical form
Solutions for Sealant
Deep frozen
Colourless to pale yellow and clear to slightly turbid solutions.
Component 1, Sealer Protein Solution: pH 6.5 – 8.0
Component 2, Thrombin Solution: pH 6.0 – 8.0
4. Clinical particulars
4.1 Therapeutic indications
ARTISS is indicated as a tissue glue to adhere/seal subcutaneous
tissue in plastic, reconstructive and burn
surgery, as a replacement or an adjunct to sutures or staples (see
5.1). In addition, ARTISS is indicated as
an adjunct to hemostasis on subcutaneous tissue surfaces.
4.2 Posology and meth