Raplixa

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

human fibrinogen, human thrombin

Available from:

Mallinckrodt Pharmaceuticals Ireland Limited

ATC code:

B02BC30

INN (International Name):

human fibrinogen, human thrombin

Therapeutic group:

Antihemorrhagics

Therapeutic area:

Hemostasis, Surgical

Therapeutic indications:

Supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis.Raplixa must be used in combination with an approved gelatin sponge.Raplixa is indicated in adults over 18 years of age.

Product summary:

Revision: 6

Authorization status:

Withdrawn

Authorization date:

2015-03-19

Patient Information leaflet

22
B. PACKAGE LEAFLET
Medicinal product no longer authorised
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RAPLIXA SEALANT POWDER
Human fibrinogen/ Human thrombin
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of Section 4 for how to
report side effects.
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 of the side effects talk to your doctor, pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Raplixa is and what it is used for
2.
What you need to know before you are treated with Raplixa
3.
How to use Raplixa
4.
Possible side effects
5.
How to store Raplixa
6.
Contents of the pack and other information
1.
WHAT RAPLIXA IS AND WHAT IT IS USED FOR
The active ingredient fibrinogen is a concentrate of clottable
protein; the other active ingredient thrombin
is an enzyme that causes clottable protein to coalesce to form a plug.
Raplixa is applied during surgical operations, to reduce bleeding and
oozing during and after the operation
in adults. In combination with a gelatin sponge, Raplixa is applied or
sprayed onto cut tissue where it
forms a layer that helps to stop bleeding.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE TREATED WITH RAPLIXA
DO NOT USE RAPLIXA:
-
if you are allergic to human fibrinogen, human thrombin or any of the
other ingredients of this
medicine (listed in section 6)
-
directly inside a blood vessel
-
in endoscopic procedures (procedures that use an endoscope for viewing
internal organs) or keyhole
surgery
-
as a glue for the fixation of patches
-
as a glue for intestines (gastrointestinal anastomoses)
-
on severe arterial bleeds
Medicinal product no longer authorised
24
WARNINGS AND PRECAUTI

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of new
safety information. Healthcare professionals are asked to report any
suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Raplixa sealant powder
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of powder contains 79 mg human fibrinogen and 726 IU human
thrombin.
Raplixa is supplied in three different presentations 0.5 grams (39.5
mg human fibrinogen and 363 IU
human thrombin), 1 gram (79 mg human fibrinogen and 726 IU human
thrombin) and 2 grams (158 mg
human fibrinogen and 1452 IU human thrombin).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sealant powder
Dry white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Supportive treatment where standard surgical techniques are
insufficient for improvement of haemostasis.
Raplixa must be used in combination with an approved gelatin sponge
(see section 5.1).
Raplixa is indicated in adults over 18 years of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The use of Raplixa is restricted to experienced surgeons.
Gelatin sponges must be used in combination with Raplixa. Gelatin
sponges are CE marked and separately
supplied and packed (see instructions for use for the specific gelatin
sponge selected for use).
Posology
The amount of Raplixa to be applied and the frequency of application
should always be oriented towards
the underlying clinical needs for the patient. The dose to be applied
is governed by variables including, but
not limited to, the type of surgery, the size of the bleeding surface
area, the severity of bleeding, the mode
of application selected by the surgeon, and the number of
applications.
Application of the product must be individualised by the treating
surgeon. In clinical trials a thin layer of
Raplixa produced doses that typically ranged from 0.3 to 2 g. For som