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SPC, UK: ARTISS Solutions for Sealant

Εκδότης

Εκδότης Baxter Healthcare Ltd.
Διεύθυνση Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

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^1^/ml Aprotinin (synthetic): ...

Pharmaceutical form

Solutions for Sealant. Deep frozen Colourless to pale yellow and clear to slightly turbid solutions. ...

Therapeutic indications

ARTISS is indicated as a tissue glue to adhere/seal subcutaneous tissue in plastic, reconstructive and ...

Posology and method of administration

ARTISS is intended for hospital use only. The use of ARTISS is restricted to experienced surgeons who ...

Contraindications

ARTISS is not indicated to replace skin sutures intended to close surgical wounds. ARTISS alone is not ...

Special warnings and precautions for use

For epilesional use only. Do not apply intravascularly. Life threatening thromboembolic complications ...

Interaction with other medicinal products and other forms of interaction

No formal interaction studies have been performed. Similar to comparable products or thrombin solutions, ...

Fertility, pregnancy and lactation

The safety of fibrin sealants/haemostatics for use in human pregnancy or breastfeeding has not been established ...

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 ...

Overdose

No case of overdose has been reported.

Pharmacodynamic properties

Pharmacotherapeutic group: local hemostatics, ATC code: B02BC; tissue adhesives ATC code: V03AK ARTISS ...

Pharmacokinetic properties

ARTISS is intended for epilesional use only. Intravascular administration is contraindicated. As a consequence, ...

Preclinical safety data

No preclinical safety data are available for ARTISS (thrombin 4 IU/ml). Toxicity studies were done with ...

List of excipients

Component 1: Sealer Protein Solution Human Albumin Solution L-Histidine Niacinamide Polysorbate 80 (Tween ...

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal ...

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 ...

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 ...

Special precautions for disposal and other handling

General To prevent ARTISS from adhering to gloves and instruments, wet these with sodium chloride solution ...

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
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.