Actilyse Cathflo 2 mg powder for solution for injection and infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Alteplase

Available from:

Boehringer Ingelheim International GmbH

ATC code:

B01AD02

INN (International Name):

Alteplase

Dosage:

2 milligram(s)

Pharmaceutical form:

Powder and solvent for solution for injection/infusion

Therapeutic area:

alteplase

Authorization status:

Marketed

Authorization date:

2010-04-09

Patient Information leaflet

A1;2mg/IE/PIL/II/144/G+WS/963 - clean
03/02/22
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACTILYSE
® CATHFLO
® 2 MG POWDER FOR SOLUTION FOR INJECTION AND INFUSION
alteplase
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Actilyse Cathflo is and what it is used for
2.
What you need to know before you receive Actilyse Cathflo
3.
How is Actilyse Cathflo administered
4.
Possible side effects
5.
How to store Actilyse Cathflo
6.
Contents of the pack and other information
1.
WHAT ACTILYSE CATHFLO IS AND WHAT IT IS USED FOR
The active substance in Actilyse Cathflo is alteplase. It belongs to a
group of medicines called thrombolytic
agents. These medicines act by dissolving blood clots.
Actilyse Cathflo is used to clear catheters which are blocked by blood
clots.
2.
WHAT YOU NEED TO KNOW BEFORE YOU GET ACTILYSE CATHFLO
YOU SHOULD NOT RECEIVE ACTILYSE CATHFLO

if you are allergic (hypersensitive) to alteplase, to any of the other
ingredients of this medicine (listed
in section 6) or to gentamicin (a trace residue from the manufacturing
process).
YOUR DOCTOR WILL TAKE SPECIAL CARE WITH ACTILYSE CATHFLO

if you have had any allergic reaction other than a sudden
life-threatening allergic reaction (severe
hypersensitivity) to the active substance alteplase, to gentamicin (a
trace residue from the
manufacturing process) or to any of the other ingredients of this
medicine (listed in section 6).

if you have a bleeding in any part of the body

if in the past 48 hours you have had a condition that increases your
risk of bleeding, including:
-
surgery
-
biopsy (a procedure for obtaining a tissue specimen)
-
puncture
-
delivery of a baby

if you have a bleeding d

Summary of Product characteristics

Health Products Regulatory Authority
14 September 2022
CRN00CR60
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actilyse Cathflo 2 mg powder for solution for injection and infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial with powder contains:
2 mg alteplase (corresponding to 1,160,000 IU)
Alteplase is produced by recombinant DNA technique using a Chinese
hamster ovary cell-line. The specific activity of alteplase
in-house reference material is 580,000 IU/mg. This has been confirmed
by comparison with the second international WHO
standard for t-PA. The specification for the specific activity of
alteplase is 522,000 to 696,000 IU/mg.
Each constituted vial will deliver 2 mg of alteplase.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection and infusion.
The powder is presented as a colourless to pale yellow lyophilizate
cake. The reconstituted preparation is a clear and colourless
to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Thrombolytic treatment of occluded central venous access devices
including those used for haemodialysis
The 2 mg vial is the only recommended presentation of alteplase for
use in this indication.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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 k