Medicinal Products

ACTILYSIS 2 mg

Generic drug of the therapeutic class: Haemostasis and blood
active ingredients: Alteplase
laboratory: Boehringer Ingelheim

Powder and solvent for solution for injection or IV infusion
Box of 5 vials of powder (+ ampoules of solvent) of 2 mg
All forms

Indication

Thrombolytic treatment of occluded central venous catheters including those used in hemodialysis.

The 2 mg vial is the only recommended presentation for use in this indication.

Dosage ACTILYSE 2 mg Powder and solvent for solution for injection or for infusion IV Box of 5 vials of powder (+ ampoules of solvent) of 2 mg

Treatment with alteplase should be initiated as soon as possible after the onset of symptoms.

The following dosing recommendations should be applied:

A dose of up to 2 mg of alteplase administered up to twice for any occlusion may be used to restore the permeability of single or multiple lumen catheters, including those used in hemodialysis, to become dysfunctional due to thrombotic occlusion.

The reconstitution of a final concentration of 1 mg of alteplase per ml is recommended for use in this indication. In patients weighing at least 30 kg, a total dose of 2 mg of alteplase in 2 ml of reconstituted solution should be instilled into the obstructed central venous catheter.

In patients weighing less than 30 kg, the volume of the reconstituted solution to be instilled into the obstructed central venous catheter should be 110% of the volume of the internal lumen of the catheter. The total dose of alteplase should not exceed 2 mg. Thus, for a catheter with an internal volume of 1.0 ml, the total dose of Actilyse should be 1.1 mg for a volume of 1.1 ml.

If catheter patency is not restored after 120 minutes of contact with the first dose, a second equivalent dose may be instilled.

Method for restoring the permeability of a catheter:

The reconstituted solution should be instilled into the central venous access device not functioning properly.

The 2 mg vial is the only recommended presentation for use in this indication. For instructions prior to reconstitution prior to administration, see section Instructions for use, handling and disposal .

1. Reconstitute the contents of an injection vial to obtain a final concentration of 1 mg of alteplase per ml. For catheters with lumens greater than 2 ml, the reconstituted solution can be further diluted with a sterile 9 mg / ml (0.9%) sodium chloride solution to inject the desired volume, ie for a catheter with an internal volume of 2.5 ml, the total dose of Actilyse should be 2.0 mg in a volume of 2.5 ml.

2. Instill the appropriate dose of Actilyse into the obstructed central venous catheter.

3. After 30 minutes of contact, assess the catheter's patency by attempting to draw blood. If permeability is restored, refer to Step 6. Otherwise, proceed to Step 4.

4. After 120 minutes of contact, assess catheter patency by attempting to aspirate blood and catheter contents. If permeability is restored, refer to Step 6. If not, continue to Step 5.

5. If the catheter's patency is not restored after the first dose, a second equivalent dose should be instilled. Repeat the procedure beginning with step 1. If after a second dose of alteplase the permeability is still not restored, consider replacing the catheter

6. If catheter patency has been restored, aspirate 4-5 ml of blood in patients weighing at least 10 kg, or 3 ml in patients weighing less than 10 kg, to remove ACTILYSE and residual clot, and irrigate slowly catheter with sterile sodium chloride 9 mg / ml (0.9%) solution for injection.

Against indications

ACTILYSIS 2 mg should not be administered to patients with known hypersensitivity to the active substance alteplase, gentamicin (a trace residue from the manufacturing process), or to any of the excipients listed in this section. Composition section.

Adverse effects Actilyse

The side effects listed below are presented by frequency and system organ class. Frequency groups are defined according to the following convention: Very common (≥1 / 10), Common (≥1 / 100, <1/10), Uncommon (≥1 / 1000, <1/100), Rare (≥ 1/10 000, <1/1000), Very rare (<1 / 10, 000), Not known (can not be estimated from the available data).

In clinical trials conducted in the treatment of catheters occluded with Actilyse, the following adverse effects were observed:

Infections and infestations

Uncommon: sepsis

General disorders and administration site conditions

· Uncommon: catheter related complications,

· Rare: fever.

In general, all adverse reactions seen during systemic administration of Actilyse are also likely to occur in the treatment of occluded catheters in cases where Actilyse reaches the general circulation (including haemorrhage, embolism, hypersensitivity reactions / anaphylactoid reactions, decreased blood pressure, nausea, vomiting, increased body temperature).

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr

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