Riastap 1 g Powder for solution for injection / infusion

国: マルタ

言語: 英語

ソース: Medicines Authority

有効成分:

HUMAN FIBRINOGEN

から入手可能:

CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Germany

ATCコード:

B02BB01

INN（国際名）:

HUMAN FIBRINOGEN 1 g

医薬品形態:

POWDER FOR SOLUTION FOR INJECTION/INFUSION

構図:

HUMAN FIBRINOGEN 1 g

処方タイプ:

POM

治療領域:

ANTIHEMORRHAGICS

認証ステータス:

Authorised

承認日:

2017-01-19

情報リーフレット

Page
1
of
8
PACKAGE LEAFLET: INFORMATION FOR THE USER
RIASTAP
® 1 G
Powder for solution for injection / infusion
Human fibrinogen
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 or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any of side effects talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Riastap is and what it is used for
2.
What you need to know before you use Riastap
3.
How to use Riastap
4.
Possible side effects
5.
How to store Riastap
6.
Contents of the pack and other information
1.
WHAT RIASTAP IS AND WHAT IT IS USED FOR
_WHAT IS RIASTAP? _
Riastap contains human fibrinogen which is a protein important for
blood clotting
(coagulation). Lack of fibrinogen means that the blood does not clot
as quickly as it should,
which results in an increased tendency of bleeding. The replacement of
human fibrinogen
with Riastap will correct the coagulation defect.
_WHAT IS RIASTAP USED FOR? _
Riastap is used for treatment of bleeding in patients with a
congenital lack of fibrinogen
(hypo- or afibrinogenaemia) with bleeding tendency.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE RIASTAP
The following sections contain information that your doctor should
consider before you are
given Riastap.
DO NOT USE RIASTAP:
•
if you are allergic to human fibrinogen or any of the other
ingredients of this medicine
(listed in section 6).
PLEASE INFORM YOUR DOCTOR IF YOU ARE ALLERGIC TO ANY MEDICINE OR FOOD.
Page
2
of
8
WARNINGS AND PRECAUTIONS:
•
if you have experienced allergic reactions to Riastap in the past. You
should take
antihistamines and corticosteroids prophylactically if advised by your
doctor.
•
when allergic

製品の特徴

Page
1
of
11
SUMMARY OF PRODUCT CHARACTERISTICS
Page
2
of
11
1.
NAME OF THE MEDICINAL PRODUCT
Riastap 1 g
Powder for solution for injection / infusion
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Riastap is presented as a powder for solution for injection or
infusion containing
1 g human fibrinogen per vial.
The product reconstituted with 50 ml of water for injections contains
approximately
20 mg/ml human fibrinogen.
The content of clottable fibrinogen is determined according to the
European
Pharmacopoeia monograph for human fibrinogen.
Excipients recognised to have a known effect:
Sodium up to 164 mg (7.1 mmol) per vial.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
White powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of bleeding in patients with congenital hypo-, or
afibrinogenaemia with
bleeding tendency.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physician
experienced in the
treatment of coagulation disorders.
_POSOLOGY_
The dosage and duration of the substitution therapy depend on the
severity of the
disorder, location and extent of bleeding and the patient’s clinical
condition.
The (functional) fibrinogen level should be determined in order to
calculate individual
dosage and the amount and frequency of administration should be
determined on an
individual patient basis by regular measurement of plasma fibrinogen
level and
continuous monitoring of the clinical condition of the patient and
other replacement
therapies used.
Page
3
of
11
Normal plasma fibrinogen level is in the range of 1.5 – 4.5 g/l. The
critical plasma
fibrinogen level below which haemorrhages may occur is approximately
0.5 – 1.0 g/l.
In case of major surgical intervention, precise monitoring of
replacement therapy by
coagulation assays is essential.
Initial Dose
If the patient’s fibrinogen level is not known, the recommended dose
is 70 mg per kg of
body weight (BW) administered intraven