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ACTILYSE CATHFLO 2 MG POWDER FOR SOLUTION FOR INJECTION AND INFUSION

Active substance(s): ALTEPLASE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

abcd

Actilyse® Cathflo® 2 mg
powder for solution for
injection and infusion

Alteplase

3. How is Actilyse Cathflo
administered

Actilyse Cathflo will be prepared and
administered to you by your doctor
or by a health care professional. It is
not for self-administration.

The dose you are given depends on
your body weight. The maximum
dose of Actilyse Cathflo is 2 mg but
will be lower if you weigh less than
30 kg.

Actilyse Cathflo is filled in the
What is in this leaflet:
1. What Actilyse Cathflo is and what blocked catheter. After 30 min your
doctor will check if the catheter has
it is used for
2. What you need to know before you already been cleared. If this is the
case, treatment with Actilyse Cathflo
receive Actilyse Cathflo
will be stopped. If this is not yet the
3. How is Actilyse Cathflo
case, the product will remain in the
administered
catheter for another 90 min.
4. Possible side effects

5. How to store Actilyse Cathflo
After treatment, Actilyse Cathflo is
6. Contents of the pack and other
removed from the catheter. The
information
catheter is rinsed with sterile saline
solution.


1. What Actilyse Cathflo is and
If the catheter is still blocked after
what it is used for
your first treatment with Actilyse

Cathflo, the whole procedure may be
The active substance in Actilyse
repeated once.
Cathflo is alteplase. It belongs to a

group of medicines called
Actilyse Cathflo should not be mixed
thrombolytic agents. These
with other medicines.
medicines act by dissolving blood

clots.
If you have any further questions on
Actilyse Cathflo is used to clear
the use of this medicine, ask your
catheters which are blocked by doctor or nurse.
blood clots.
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.

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)
- puncture
- delivery of a baby
• if you have a bleeding disorder or
tendency to bleed
• if you have severe liver or kidney
disease
• if a blood vessel located close to
the catheter is blocked by blood
clots (venous thrombosis)
• if there is or may be an infection
located in the catheter

Other medicines and Actilyse Cathflo
Tell your doctor if you are taking,
have recently taken or might take any
other medicines, including medicines
obtained without a prescription. It is
particularly important that you tell
your doctor if you are taking or have
recently taken:
• any medicines which are used to
“thin” the blood, including:
- acetylsalicylic acid
- warfarin
- coumarin
- heparin
• certain medicines used to treat high
blood pressure (ACE inhibitors).

Pregnancy and breast-feeding
Ask your doctor for advice before
taking any medicine. Your doctor will
only give you Actilyse Cathflo if the
possible benefit outweighs the
possible risk to your baby.

Actilyse Cathflo may contain
gentamicin as trace residue from the
manufacturing process; the
packaging contains natural rubber
(latex).



4. Possible side effects

Like all medicines, this medicine can
cause side effects, although not
everybody gets them.

The side effects described below
have been experienced by people
given Actilyse Cathflo:

Uncommon (occurs in less than 1 in
100 patients receiving the medicine)
• release of an infection from the
catheter to the blood vessels
leading to blood poisoning (sepsis)
• damage to the catheter such as:
- blockage
- leakage
- burst
Rare (occurs in less than 1 in 1,000
patients receiving the medicine)
• fever
In principle, all undesirable effects as
found for the application of Actilyse
(10, 20, 50 mg of alteplase) for heart
attacks, pulmonary embolism or
stroke may also occur during
treatment of catheters blocked by
blood clots. This is however only
possible in cases where Actilyse
Cathflo (2 mg of alteplase) reaches
the blood circulation. The following
side effects may occur: e.g. bleeding
(haemorrhage), sudden blocking of a
blood vessel (embolism), allergic
(hypersensitivity/anaphylactoid)
reactions, blood pressure decreased,
nausea, vomiting, body temperature
increased. However none of these
side effects has ever been observed
with Actilyse Cathflo so far. Due to
the small amount of medicine used,
these side effects are very unlikely to
occur with Actilyse Cathflo (2 mg) –
apart from allergic reactions for
which a small amount may be
sufficient. When using the product
Actilyse (10, 20, 50 mg of alteplase),
allergic reactions have been observed
rarely.

Reporting of side effects
If you get any side effects, talk to
your doctor or nurse. This includes
any possible side effects not listed in
this leaflet. You can also report side
effects directly (see details below). By
reporting side effects, you can help
provide more information on the
safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL – Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie



Mandatory in

File information

TD

Printfile

Issue date of TD:

15.11.2012

Yes

Yes

PPM SKU:

P035389

No

Yes

PPM SKU version: 

001

No

Yes

Issue date of artwork:

15.01.2015

No

Yes

Print colors:

PAN Black

No

Yes

Mat. No. Pack. Site:

307972-01

No

Yes

Min. font size:

12pt

Legend case version:

V4.0 01/OCT/2012 (please do not change or remove it)

Technical information
a = Batch No.

b = Expiry date

c = Manufacturing date

d = Price/Sample/Clinic

Technical colors
BI-Diecut-Legendcase

Free area

Gluepoints

Additional Requirements of Packaging site
Template name: TD-PI_160x630

Index: b

A
B
C
Mass
Mass
Mass

A
B
C

8,5 mm
2,2 mm
max. 42,5 mm

5. How to store Actilyse Cathflo

Normally you will not be asked to
store Actilyse Cathflo as it will be
given to you by your doctor.

Keep this medicine out of the sight
and reach of children.

Store in a refrigerator (2 – 8 °C).
Store in the original package in order
to protect from light.

Do not use this medicine after expiry
date which is stated on the vial label
and the carton. The expiry date refers
to the last day of that month.

After reconstitution: From a
microbiological point of view, the
product should be used immediately
after reconstitution. If not used
immediately, in-use storage times
and conditions prior to use are the
responsibility of the user and would
normally not be longer than 24 hours
at 2 – 8°C.

6. Contents of the pack and other
information

What Actilyse Cathflo contains
• The active substance is alteplase. Each
vial contains 2 mg (corresponding
to 1,160,000 IU) alteplase.
• The other ingredients are arginine,
phosphoric acid (for pH-adjustment)
and polysorbate 80.
• The rubber stopper of the
packaging material contains natural
rubber (latex)
What Actilyse Cathflo looks like and
contents of the pack
Actilyse Cathflo is a powder for
solution for injection and infusion.
Each pack contains five vials, each with
2 mg alteplase.
Marketing Authorisation Holder
Boehringer Ingelheim Limited
Ellesfield Avenue, Bracknell, Berkshire,
RG12 8YS, United Kingdom
Manufacturer
Boehringer Ingelheim Pharma
GmbH & Co. KG
Birkendorfer Strasse 65
D-88397 Biberach/Riss
Germany

This leaflet was last revised in 01/2015.
© Boehringer Ingelheim Limited 2015


-----------------------------------------------------------------------------------The following information is
intended for medical or healthcare
professionals only:
Instructions for reconstitution

Instructions for administration in
occluded central venous access
devices including those used for
haemodialysis

1. Reconstitute the content of an
injection vial to a final concentration
of 1 mg alteplase per ml. For
catheters with a lumen volume
greater than 2 ml, the reconstituted
solution can be further diluted with
sterile sodium chloride 9 mg/ml
(0.9 %) solution for injection to the
desired volume. I.e. for a catheter
The 2 mg vial (with a total amount of with internal volume of 2.5 ml the
total dose of Actilyse Cathflo would
2.2 mg alteplase including 0.2 mg
be 2.0 mg in a volume of 2.5 ml.
overage which will remain in the
transfer syringe so that the amount
2. Instil the appropriate dose of
practically administered is 2 mg
Actilyse Cathflo into the
alteplase) should always be
reconstituted to a final concentration dysfunctional central venous
access device.
of 1 mg alteplase per ml.
The 2 mg presentation of alteplase is
not indicated for use in myocardial
infarction, acute pulmonary embolism
or acute ischaemic stroke (due to risk
of massive underdosing). Only 10, 20
or 50 mg presentations are indicated
for use in those indications.

To this end, 2.2 mL sterile water for
injection should be transferred to the
vial containing the Actilyse Cathflo
powder by use of a syringe with a
suitable measuring precision under
aseptic conditions.

3. After 30 minutes of dwell time,
assess catheter function by
attempting to aspirate blood. If the
catheter is functional, go to Step 6.
If the catheter is not functional, go
to Step 4.

The reconstituted solution should
then be instilled into the dysfunctional
central venous access device. It may
be diluted further with sterile sodium
chloride 9 mg/ml (0.9 %) solution for
injection up to a minimal
concentration of 0.2 mg/ml. A
dilution of the reconstituted solution
with sterilised water for injections or
in general, the use of carbohydrate
infusion solutions, e.g. dextrose is
not recommended. Actilyse Cathflo
should not be mixed with other
medicinal products in the same
catheter (not even with heparin).

4. After 120 minutes of dwell time,
assess catheter function 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.

For incompatibilities see section 6.2
of the SmPC.
When reconstituting the product
from the respective amount of
powder and solvent, the mixture
should only be swirled gently until
complete dissolution. Any vigorous
agitation should be avoided to
prevent foam formation.
The reconstituted preparation is a
clear and colourless to pale yellow
solution. Prior to administration it
should be inspected visually for
particles and colour.

5. If catheter function 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 device remains
dysfunctional consider device
replacement.
6. If catheter function has been
restored, aspirate 4–5 ml of blood
in patients weighing 10 kg or more,
or 3 ml in patients with a body
weight below 10 kg to remove
Actilyse Cathflo and residual clot,
and gently irrigate the catheter
with sterile sodium chloride
9 mg/ml (0.9 %) solution for
injection.

For storage conditions, please see
section 5 of this leaflet.
The reconstituted solution is for
single use only. Any unused solution
should be discarded.

307972-01

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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