ARTISS Solutions for sealant

Product name and form

ARTISS Solutions for Sealant.

Deep froze.

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

Qualitative and quantitative composition

Component 1:

Sealer Protein Solution

Human Fibrinogen (as clottable protein) 91 mg1/ml

Aprotinin (synthetic): 3000 KIU2/ml

Component 2:

Thrombin Solution

Human Thrombin: 4 IU3/ml

Calcium Chloride: 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 mixing1 ml2 ml4 ml10 ml
Component 1: Sealer protein solution
Human Fibrinogen (as clottable protein)45.5 mg91 mg182 mg455 mg
Aprotinin (synthetic)1,500 KIU3,000 KIU6,000 KIU15,000 KIU
Component 2: Thrombin Solution
Human Thrombin2 IU4 IU8 IU20 IU
Calcium Chloride20 μmol40 μmol80 μmol200 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.

List of Excipients

Component 1: Sealer Protein Solution

Human Albumin Solution
Polysorbate 80 (Tween 80)
Sodium Citrate Dihydrate
Water for Injections

Component 2: Thrombin Solution

Human Albumin Solution
Sodium Chloride
Water for Injections

Pack sizes and marketing

1 ml, 2 ml, or 5 ml of sealer protein solution and 1, 2 or 5 ml of Thrombin Solution in a single-use double-chamber syringe (polypropylene) with a tip-cap in a bag, and one device set with one double syringe plunger, 2 joining pieces and 4 application cannulae.

Pack size of 1 (1 × 1 ml + 1 ml, 1 × 2 ml + 2 ml, 1 × 5 ml + 5 ml)

Both Sealer Protein Solution and Thrombin Solution are contained in a single-use double-chamber syringe made of polypropylene.

Not all pack sizes may be marketed.

Other accessories for application of the product can be obtained from BAXTER.

Marketing authorization holder

Baxter Healthcare Ltd
Caxton Way
IP24 3SE
United Kingdom

Marketing authorization dates and numbers

PL 00116/0634

Date of First Authorisation: 11 March 2009

Date of Last Renewal: 23 December 2013


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