ACTILYSE CATHFLO

Actilyse Cathflo should be given as early as possible after occlusion. The following dose guidelines apply. Posology A dose of up to 2 mg alteplase instilled in an occluded central venous access device up to two times for each occlusion can be used to restore function of ports, single and multiple lumen catheters including those used for haemodialysis, which became dysfunctional due to thrombotic occlusion.

For use in this indication reconstitution to a final concentration of 1 mg alteplase per ml is recommended. In patients with a body weight of 30 kg or more, a total dose of up to 2 mg alteplase in 2 ml of reconstituted solution should be instilled into the occluded central venous access device.

In patients with a body weight below 30 kg, the volume of reconstituted solution to be instilled into the occluded central venous access devices should correspond to 110% of the internal lumen volume of the device. The total dose of alteplase per each instillation must not exceed 2 mg.

e. 1 ml. Re-administration If occluded central venous access device functionality is not restored at 120 minutes after the first dose, a second dose of equal amount may be instilled. Paediatric population The Paediatric population is covered by the general dosing scheme as described above.

Method of catheter clearance The reconstituted solution should be instilled into the occluded central venous access device and is for immediate use. Only 2 mg vials of alteplase are indicated for use in this indication. 6. 1. Reconstitute the content of an injection vial to a final concentration of 1 mg alteplase per ml.

9 %) solution for injection to the desired volume. e. 5 ml. 2. Instil the appropriate dose of Actilyse Cathflo into the occluded central venous access device. 3. After 30 minutes of dwell time, assess catheter functionality by attempting to aspirate blood.

If the catheter is functional, go to Step 6. If the catheter is not functional, go to Step 4. 4. After 120 minutes of dwell time, assess catheter functionality by attempting to aspirate blood and catheter contents. If the catheter is functional, go to Step 6.

If the catheter is not functional, go to Step 5. 5. If catheter functionality is not restored after the first dose, a second dose of equal amount may be instilled. Repeat the procedure beginning with Step 1. If after a second dose of alteplase the catheter functionality has not been restored consider catheter replacement.

6. 9 %) solution for injection.

Adverse reactions listed below are classified according to frequency and system organ class.

Frequency groupings are defined according to the following convention:

Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data). e. g. g. haemorrhage, embolism, hypersensitivity reactions, blood pressure decreased, nausea, vomiting, body temperature increased).

However, pharmacokinetic data indicate that physiologically relevant plasma concentrations are not reached using this dosage. Immune system disorders, on the other hand, can be regarded dose-independent and have therefore been copied from the systemic application; immune system disorders have however not been observed in clinical trials with Actilyse Cathflo.

Paediatric Population Based on clinical study data, the safety profile for use in children is comparable with the one observed in adults. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. The appropriate pack size of alteplase product should be chosen carefully and in accordance with the intended use.

The 2 mg vial of alteplase is not indicated for use in acute myocardial infarction, acute pulmonary embolism or acute ischaemic stroke (due to risk of massive under dosing). Only 10, 20 or 50 mg vials are indicated for use in those indications.

Coinstillation of heparin The coinstillation of heparin with alteplase has not been shown to improve the rates of catheter function restoration and is not recommended. If heparin is considered necessary to prevent re-occlusion this should be instilled separately after catheter function has been restored.

Damage to the vascular wall and collapse of catheters Catheter dysfunction may be caused by a variety of conditions other than thrombus formation, such as catheter malposition, mechanical failure, constriction by a suture, and lipid deposits or drug precipitates within the catheter lumen.

Because of the risk of damage to the vascular wall or collapse of soft-walled catheters, vigorous suction must not be applied during attempts to determine catheter occlusion. Excessive pressure must be avoided when alteplase is instilled into the catheter.

Such force could cause rupture of the catheter or expulsion of the clot into the circulation. Particular caution is necessary if small volume syringes (≤ 1 ml) are used for application, especially if small volume catheters are used as typical in the paediatric population.

Bleeding The most frequent adverse reaction associated with all thrombolytics in all approved indications is bleeding. Alteplase has not been studied in patients with occluded catheters known to be at risk for bleeding events that may be associated with the use of thrombolytics.

Caution should be exercised with patients who have active internal bleeding or who have had any of the following within 48 hours before start of instillation: surgery, obstetrical delivery, percutaneous biopsy of viscera or deep tissues, or puncture of non-compressible vessels.

, venous thrombosis in the region of the catheter). Death and permanent disability have been reported in patients who have experienced stroke and other serious bleeding episodes when receiving pharmacologic doses of a thrombolytic. , intracranial, gastrointestinal, retroperitoneal, pericardial) occur, treatment with alteplase should be stopped and the drug should be withdrawn from the catheter.

Infection Using alteplase in patients whose catheters are occluded by infected thrombi may release microorganisms into the systemic circulation leading to sepsis. As with all catheterisation procedures, care should be taken to maintain aseptic technique and appropriate antibiotic treatment used as necessary.

Hypersensitivity Antibody formation in patients receiving one or more doses of alteplase for restoration of occluded central venous access devices has not been studied. Hypersensitivity reactions associated with the instillation of alteplase can be caused by the active substance alteplase or any of the excipients.

If a severe hypersensitivity reaction occurs, the instillation should be discontinued and appropriate treatment should be promptly initiated.

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