ACTILYSE CATHFLO

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

ALTEPLASE

Dostupné z:

Boehringer Ingelheim Limited

ATC kód:

B01AD02

INN (Medzinárodný Name):

ALTEPLASE

Dávkovanie:

2 Milligram

Forma lieku:

Pdr+Solv for soln for inf/inj

Typ predpisu:

Product subject to prescription which may not be renewed (A)

Terapeutické oblasti:

alteplase

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2010-04-09

Príbalový leták

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.
2.
WHAT YOU NEED TO KNOW BEFORE
YOU GET ACTILYSE CATHFLO
YOU SHOULD NOT RECEIVE ACTILYSE
CATHFLO
• if you are allergic (hypersensitive)
to the active substance alteplase, to
gentamicin (a trace residue from
the manufacturing process), to
natural rubber (also called latex
which is part of the packaging
material) or to any of the other
ingredients of this medicine (listed
in section 6).
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), to natural
rubber (also called latex which is
part of the packaging material) 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)
-
punctur

Súhrn charakteristických

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 a 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 soon as possible after occlusion.
The following dose guidelines apply.
_Posology_
A dose of up to 2 mg alteplase administered up to two times for any
one 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 2 mg
alteplase in 2 ml of reconstituted solution should
be instilled into the dysfunctional central venous access device.
In patients with a body weight below 30 kg, the volume of
reconstituted solution to be instilled into the dysfunctional
central venous access devices should