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ARTISS Solutions for sealant

Active ingredients: Human fibrinogen Aprotinin Thrombin Calcium chloride

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.

Chemical substance
Description
Human fibrinogen

Human fibrinogen (coagulation factor I), in the presence of thrombin, activated coagulation factor XIII (F XIIIa) and calcium ions is converted into a stable and elastic three-dimensional fibrin haemostatic clot. The administration of human fibrinogen concentrate provides an increase in plasma fibrinogen level and can temporarily correct the coagulation defect of patients with fibrinogen deficiency.

Aprotinin

Aprotinin is a broad spectrum protease inhibitor which has antifibrinolytic properties. By forming reversible stoichiometric enzyme-inhibitor complexes, aprotinin acts as an inhibitor of human trypsin, plasmin, plasma kallikrein and tissue kallikrein, thus inhibiting fibrinolysis.

Thrombin
Calcium chloride

Calcium is the most abundant mineral in the body, and is an essential body electrolyte. Homeostasis is mainly regulated by the parathyroid hormone, by calcitonin, and by the activated form of vitamin D. Calcium is a structural component of bones and teeth. It is also required for blood clotting, neurotransmitter release, muscle contraction and normal heartbeat.

List of excipients

Component 1: Sealer Protein Solution

Human Albumin Solution
L-Histidine
Niacinamide
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
Authorization dates

Baxter Healthcare Ltd
Caxton Way
Thetford
Norfolk
IP24 3SE
United Kingdom

Date of First Authorisation: 11 March 2009

Date of Last Renewal: 23 December 2013

Marketing authorization number:

PL 00116/0634