ARTISS Solutions for sealant
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
Εκδότης | Baxter Healthcare Ltd. |
---|---|
Διεύθυνση | Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom |
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Name of the medicinal product
ARTISS Solutions for Sealant. Deep froze.
Qualitative and quantitative composition
Component 1: Sealer Protein Solution Human Fibrinogen (as clottable protein) 91 mg<sup>1</sup>/ml Aprotinin (synthetic): 3000 KIU<sup>2</sup>/ml Component 2: Thrombin Solution Human Thrombin: 4 IU<sup> ...
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
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 ...
Posology and method of administration
ARTISS is intended for hospital use only. The use of ARTISS is restricted to experienced surgeons who have been trained in the use of ARTISS. Posology The amount of ARTISS to be applied and the frequency ...
Contraindications
ARTISS is not indicated to replace skin sutures intended to close surgical wounds. ARTISS alone is not indicated for the treatment of massive and brisk arterial or venous bleeding. ARTISS must never be ...
Special warnings and precautions for use
For epilesional use only. Do not apply intravascularly. Life threatening thromboembolic complications may occur if the preparation is applied intravascularly. Soft tissue injection of ARTISS carries the ...
Interaction with other medicinal products and other forms of interaction
No formal interaction studies have been performed. Similar to comparable products or thrombin solutions, the product is denatured after exposure to solutions containing alcohol, iodine or heavy metals ...
Fertility, pregnancy and lactation
The safety of fibrin sealants/haemostatics for use in human pregnancy or breastfeeding has not been established in controlled clinical trials. Animal studies have also not been performed. Therefore, the ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Intravascular injection could lead to thromboembolic events and DIC and there is also a risk of anaphylactic reactions (see 4.4). Hypersensitivity or allergic reactions (which may include angioedema, burning ...
Overdose
No case of overdose has been reported.
Pharmacodynamic properties
Pharmacotherapeutic group: local hemostatics, ATC code: B02BC; tissue adhesives ATC code: V03AK ARTISS can replace sutures or staples when used for fixation of skin grafts to burned or otherwise injured ...
Pharmacokinetic properties
ARTISS is intended for epilesional use only. Intravascular administration is contraindicated. As a consequence, intravascular pharmacokinetic studies were not performed in man. Pharmacokinetic studies ...
Preclinical safety data
No preclinical safety data are available for ARTISS (thrombin 4 IU/ml). Toxicity studies were done with Fibrin Sealants containing thrombin 500 IU/ml, as representative for products containing thrombin ...
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 ...
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. Oxycellulose-containing preparations may reduce the efficacy of ARTISS and should not be ...
Shelf life
Shelf life: 2 years.
Special precautions for storage
Store and transport frozen (at ≤ -20°C). Keep the syringe in the outer carton in order to protect from light. Unopened pouches, thawed at room temperature, may be stored for up to 14 days at controlled ...
Nature and contents of container
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 ...
Special precautions for disposal and other handling
General To prevent ARTISS from adhering to gloves and instruments, wet these with sodium chloride solution before contact. As a guideline for the gluing of surfaces, 1 pack of ARTISS 2 ml (i.e., 1 ml Sealer ...
Marketing authorization holder
Baxter Healthcare Ltd Caxton Way Thetford Norfolk IP24 3SE United Kingdom
Marketing authorization number(s)
PL 00116/0634
Date of first authorization / renewal of the authorization
Date of First Authorisation: 11 March 2009 Date of Last Renewal: 23 December 2013
Date of revision of the text
April 2014