Actilyse Cathflo 2 mg, poeder voor oplossing voor injectie en infusie

Country: Նիդերլանդեր

language: հոլանդերեն

source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

active_ingredient:

ALTEPLASE 2 mg/flacon

MAH:

Boehringer Ingelheim B.V. Comeniusstraat 6 1817 MS ALKMAAR

ATC_code:

B01AD02

INN:

ALTEPLASE 2 mg/flacon

pharmaceutical_form:

Poeder voor oplossing voor injectie of infusie

composition:

ARGININE, (L-) ; FOSFORZUUR (E 338) ; POLYSORBAAT 80 (E 433) ; WATER, GEZUIVERD,

administration_route:

Parenteraal

therapeutic_area:

Alteplase

leaflet_short:

Hulpstoffen: ARGININE, (L-); FOSFORZUUR (E 338); POLYSORBAAT 80 (E 433); WATER, GEZUIVERD;

authorization_date:

1900-01-01

PIL

2 PACKAGE LEAFLET: INFORMATION FOR THE USER
ACTILYSE CATHFLO
2 MG, POEDER VOOR OPLOSSING VOOR INJECTIE EN INFUSIE
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 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 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)
•
i

SPC

2
1.
NAME OF THE MEDICINAL PRODUCT
Actilyse Cathflo 2 mg, poeder voor oplossing voor injectie en infusie
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 kg, the volume of
reconstituted solution to be instilled into the
occluded central venous access devices s