ACTILYSE CATHFLO 2 MG

Active substance: ALTEPLASE

View full screen / Print PDF » Download PDF ⇩

Transcript
 a

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Actilyse® Cathflo® 2 mg
Powder and solvent for
solution for injection
and infusion

abcd

Alteplase
Read all of this leaflet carefully before you start
using this medicine.
- Keep this leaflet. You may need to read it
again.
- If you have any further questions, ask your
doctor.
- This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
- If any of the side effects gets serious, or if you
notice any side effects not listed in this
leaflet, please tell your doctor.
In this leaflet:
1. What Actilyse Cathflo is and what it is used
for
2. Before you receive Actilyse Cathflo
3. How is Actilyse Cathflo administered
4. Possible side effects
5. How to store Actilyse Cathflo
6. Further information
1. WHAT ACTILYSE CATHFLO IS AND WHAT
IT IS USED FOR

The active substance in Actilyse Cathflo is
alteplase (see section 6: “Further information”).
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. BEFORE YOU RECEIVE ACTILYSE CATHFLO
Actilyse Cathflo will not be given by your doctor,
­ 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

Taking other medicines
Please tell your doctor if you are taking or have
recently taken 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:
• aspirin
• 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.

3. HOW IS ACTILYSE CATHFLO ADMINISTERED

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

Actilyse Cathflo is supplied as a powder and
solvent. This means that each pack contains
one or more vials with powder and an equal
amount of ampoules with the solvent (water for
injections). Before use, the solvent is added to
the powder to form a solution ready for
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 blocked catheter.
After 30 min your doctor will check if the
catheter has already been cleared. If this is the
case, treatment with Actilyse Cathflo will be
stopped. If this is not yet the case, the product
will remain in the catheter for another 90 min.

After treatment, Actilyse Cathflo is removed
from the catheter. The catheter is rinsed with
sterile saline solution.

If the catheter is still blocked after your first
treatment with Actilyse Cathflo, the whole
procedure may be repeated once.

Actilyse Cathflo should not be mixed with other
medicines.

If you have any further questions on the use of
Actilyse Cathflo, ask your doctor.

5. HOW TO STORE ACTILYSE CATHFLO

Keep out of the reach and sight of children.

Actilyse Cathflo should not be used after the
expiry date which is stated on the vial label and
the carton. The expiry date refers to the last day
of that month.

Normally you will not be asked to store Actilyse
Cathflo as it will be given to you by your doctor.
Actilyse Cathflo should be stored in a
refrigerator (2 – 8°C). Store in the original
package in order to protect from light.

Once the solution is ready for administration, it
should be used immediately. When necessary
however, the solution may be stored for 24
hours at 2°C – 8°C or for 8 hours at up to 25°C.
However your doctor will normally use the
solution immediately.

6. FURTHER INFORMATION

What Actilyse Cathflo contains

- The active substance is alteplase. Each vial
contains 2 mg (corresponding to 1,160,000 IU)
alteplase. Alteplase is produced by means of
recombinant DNA technique using a Chinese
hamster ovary cell-line.
- The other ingredients are arginine, phosphoric
acid (dilute) and polysorbate 80.
- The solvent is water for injections.
- The rubber stopper of the packaging material
contains natural rubber (latex).
What Actilyse Cathflo looks like and contents
of the pack

4. POSSIBLE SIDE EFFECTS

Actilyse Cathflo is a powder and solvent for
Like all medicines, Actilyse Cathflo can cause
solution for instillation into a blocked catheter.
side effects, although not everybody gets them. This means that each complete pack contains
several vials with powder and an equal amount
The side effects described below have been
of ampoules with the solvent.
experienced by people given Actilyse Cathflo:

For clearance of blocked catheters Actilyse
Uncommon (occurs in less than 1 in 100
Cathflo is available in the following complete
patients receiving the medicine)
pack:
- 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)

- Five vials, each with 2 mg alteplase, and five
ampoules, each with 2.2 ml water for

injections.
Marketing Authorisation Holder and
Manufacturer

Marketing Authorisation Holder

Boehringer Ingelheim Limited,
Ellesfield Avenue,
Bracknell,
In general, all undesirable effects as found for the Berkshire,
systemic application of Actilyse (10, 20, 50 mg of RG12 8YS,
alteplase) may also occur during treatment of
United Kingdom.
catheters blocked by blood clots in cases where
Actilyse Cathflo (2 mg of alteplase) reaches the Manufacturer
blood circulation (e.g. bleeding (haemorrhage),
sudden blocking of a blood vessel (embolism), Boehringer Ingelheim Pharma
allergic (hypersensitivity/anaphylactoid)
GmbH & Co. KG
reactions, blood pressure decreased, nausea,
Birkendorfer Strasse 65
vomiting, body temperature increased).
D-88397 Biberach/Riss
Germany
Tell your doctor immediately if you think you

are experiencing one of these side effects.
This leaflet was last approved in 08/2013


If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet, © Boehringer Ingelheim Limited 2013
- fever
­­

please tell your doctor.

301100-01

Expand view ⇕

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.

Hide
(web2)