Generic drug of the therapeutic class: Haemostasis and blood
Active Ingredients: Component 1: Protein Solution for Glue: Human Fibrinogen, Aprotinin, Component 2: Thrombin Solution: Human Thrombin, Calcium Chloride
laboratory: Baxter

Solutions for glue
Box of 1 pre-filled syringe with double compartment of 10 ml
All forms

Indication

ARTISS is indicated as a tissue adhesive for adhering / adhering subcutaneous tissue in plastic surgery, reconstructive surgery and burn surgery, as a substitute or supplement for sutures or staples (see section 5.1 ). In addition, ARTISS is indicated as a haemostasis adjuvant on subcutaneous tissue surfaces.

Dosage ARTISS Solutions for glue Box of 1 pre-filled syringe with double compartment of 10 ml

ARTISS is only for hospital use, used by experienced doctors or surgeons.

Dosage

The amount of ARTISS to apply and the frequency of application should always be adapted to the clinical needs of the patient.

The dose to be applied depends on multiple variables including, but not limited to, the type of surgery, the size of the surface to be adhered to, and the desired mode and number of applications.

The application of the product should be considered by the doctor in charge of the treatment. In clinical trials, individual doses varied generally between 0.2 and 12 ml. For some operations (for example, gluing large areas burned), larger volumes may be required. In clinical trials, ARTISS has not been administered to patients over 65 years of age.

The initial amount of product to be applied to a selected anatomical site or target surface should be sufficient to fully cover the desired area of ​​application. The application can be repeated if necessary.

As an indication for the application on surfaces, a box of ARTISS 2 ml (that is to say 1 ml of protein solution for glue plus 1 ml of thrombin solution) will suffice for a surface of at least 10 cm2.

To avoid the formation of an excessive amount of granulation tissue and to ensure the gradual absorption of the solidified fibrin glue, only a thin layer of the protein solution / thrombin solution mixture or of each of the components.

Method and route of administration

Intralesional way.

Prepare the solution as instructed in the Instructions for Use, Handling and Disposal.

Before application, the lesion surface should be as dry as possible.

See Instructions for use, handling and disposal for detailed instructions

Against indications

ARTISS is not indicated to replace skin sutures intended to close a surgical wound.

ARTISS alone is not indicated for the treatment of arterial or venous hemorrhages, massive and abundant.

ARTISS should never be applied intravascularly.

Hypersensitivity to the active substances or to any of the excipients (see also Warnings and Precautions with Special Warnings).

Artiss adverse effects

Involuntary intravascular injection may result in thromboembolic events and disseminated intravascular coagulation. There is also a risk of anaphylactic reaction (see Warnings and Precautions for Use ).

Hypersensitivity or allergic reactions (which may include: angioedema, burning and itching at the site of application, bradycardia, bronchospasm, chills, dyspnea, redness, generalized urticaria, headache, itching, hypotension, lethargy, nausea, itching, agitation, tachycardia, chest tightness, tingling, vomiting, wheezing) may occur in rare cases in patients treated with haemostatic substances / fibrin glues.

In isolated cases, these reactions have evolved into severe anaphylaxis. Such reactions may be particularly observed if the preparation is repeatedly applied or administered to patients with a history of hypersensitivity to aprotinin (see Warnings and Precautions ) or other components of the product. .

Although initial ARTISS therapy has been well tolerated, subsequent administration of ARTISS or systemic administration of aprotinin may result in severe anaphylactic reactions.

The components of the fibrin glue rarely cause the formation of antibodies.

For safety in relation to transmissible agents, see Warnings and Precautions for Use .

Adverse reactions reported in clinical or post-marketing studies are summarized below. The known frequencies of these adverse effects are based on a controlled clinical study involving 138 patients in whom skin grafts were fixed with ARTISS on excised burn wounds. None of these events were classified as serious. Indeterminate frequencies are based on spontaneous reports during post-marketing surveillance of fibrin glues marketed by Baxter.

The side effects and their frequency are summarized below.

Frequent (1/100 to <1/10)

Uncommon (1/1000 to <1/100)

Not known (can not be estimated from available data)

Immune system disorders:

Not known: anaphylactic reactions, hypersensitivity;

Heart conditions:

Not known: bradycardia, tachycardia;

Vascular disorders:

Not known: hypotension, hematoma;

Respiratory, thoracic and mediastinal disorders:

Not known: dyspnea;

Gastrointestinal disorders:

Not known: nausea;

Skin and subcutaneous tissue disorders:

Frequent *: pruritus;

Uncommon *: dermal cyst;

Not known: urticaria;

General disorders and abnormalities at the site of administration:

Not known: redness, scarring, edema, pyrexia;

Injury, poisoning and procedural complications:

Frequent *: failure of the skin graft;

Not known: seroma;
* In controlled clinical trials these adverse reactions also occurred at the control site without ARTISS application.

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