VERASEAL SOLUTIONS FOR SEALANT 80 mgml 500 IUml

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

מרכיב פעיל:

Human Fibrinogen; Human Thrombin

זמין מ:

GRIFOLS ASIA PACIFIC PTE. LTD.

קוד ATC:

B02BC

טופס פרצבטיות:

SOLUTION

הרכב:

Human Fibrinogen 80 mg/ml; Human Thrombin 500 IU/ml

מסלול נתינה (של תרופות):

OTHERS

סוג מרשם:

Prescription Only

תוצרת:

Instituto Grifols, S.A.

מצב אישור:

ACTIVE

תאריך אישור:

2021-04-01

מאפייני מוצר

1.4.3. Package Insert (PI)
Module 1 Fibrin Sealant Grifols
1
1.4.3. PACKAGE INSERT (PI)
QUALITATIVE AND QUANTITATIVE COMPOSITION
Component 1:
Human fibrinogen
80 mg/ml
Component 2:
Human thrombin
500 IU/ml
Produced from the plasma of human donors.
For the full list of excipients, see section _List of excipients_.
PHARMACEUTICAL FORM
Solutions for sealant.
Frozen solutions. After thawing, the solutions are clear or slightly
opalescent and colourless or pale yellow.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
VeraSeal is indicated as supportive treatment in adults where standard
surgical techniques are insufficient:
-
for improvement of haemostasis.
-
as suture support: in vascular surgery.
POSOLOGY AND METHOD OF ADMINISTRATION
The use of VeraSeal is restricted to experienced surgeons who have
been trained in the use of this medicinal product.
Posology
The volume of VeraSeal 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 surgical intervention, the size of
the area and the mode of intended application, and the number of
applications.
Application of the product must be individualised by the treating
physician. In clinical trials, the individual dosages have
typically ranged from 0.3 to 12 ml. For other procedures, larger
volumes may be required.
The initial volume of the product to be applied at a chosen anatomic
site or target surface area should be sufficient to
entirely cover the intended application area. The application can be
repeated, if necessary.
_Paediatric population_
The safety and efficacy of VeraSeal in children aged 0 to 18 years has
not yet been established. Currently available data
are described in section _Pharmacodynamic properties_, but no
recommendation on a posology can be made.
Method of administration
For epilesional use.
For instructions on preparation of the medicinal product before
administration, see section _Instructio