IMMUNINE 120IUML Powder and solvent for solution for injection or infusion

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

FACTOR IX FRACTION,DRIED

Available from:

Takeda Malaysia Sdn Bhd

INN (International Name):

FACTOR IX FRACTION,DRIED

Units in package:

1Units Units; 1 Units Units

Manufactured by:

BAXTER AG

Patient Information leaflet

Not Applicable

Summary of Product characteristics

Technical Info
Dieline
NA
NA
NA
CODE 3 OF 9
DATAMATRIX CODE
RSS / GS1-128 CODE
BODY TEXT SIZE
9.0 pt
759032
CODE ITF 2/5
NA
PHARMACODE
NA
GTIN / EAN-13 CODE
BACK
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TECHNICAL SPECIFICATION:
ARTWORK DIMENSIONS/SIZE:
ITEM NUMBER:
FRONT
0759032
VERSION: 3
PROFILE: 0402115_1_PIL_Drwg
0402115
435 x 270 mm
GRAPHICS HOUSE:
SGK Redmond
DATE:
23OCT2023
OPTIONAL: Artwork Approver outside the Shire Management System:
ROLE:
NAME:
SIGNATURE:
DATE:
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IMMUNINE 120 IU/ML
POWDER AND SOLVENT FOR SOLUTION
FOR INJECTION OR INFUSION
1. NAME OF THE MEDICINAL PRODUCT
IMMUNINE
120IU/ML
POWDER
AND
SOLVENT FOR SOLUTION FOR INJECTION
OR INFUSION
2. QUALITATIVE AND QUANTITATIVE
COMPOSITION
Active
substance:
human
coagulation
factor IX
Each Immunine 600 IU vial with powder
for
solution
for
injection
contains
nominally 600 IU human coagulation
factor IX. 1 ml of solution of IMMUNINE
contains
approximately
120
IU/ml
human
coagulation
factor
IX,
after
reconstitution
with
5ml
of
Sterilised
Water for injections.
Each
Immunine
1200
IU
vial
with
powder
for
solution
for
injection
contains
nominally
1200
IU
human
coagulation factor IX. 1 ml of solution
of
IMMUNINE
contains
approximately
120 IU/ml human coagulation factor IX,
after
reconstitution
with
10ml
of
Sterilised Water for injections.
The FIX potency (IU) is determined using
the European Pharmacopoeia one-stage
clotting test.
Produced from the plasma of human
donors.
The specific activity of IMMUNINE is not
less than 50 IU Factor IX / mg protein.
For the full list of excipients, see 6.1.
Not all strength is marketed in Malaysia.
3. PHARMACEUTICAL FORM
Powder
and
solvent
for
solution
for
injection or infusion.
White or pale yellow lyophilised powder
or friable solid.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding
episodes,
caused
by
congenital
or
acquired
Factor
IX
deficiency
(haemophilia
A,
haemophilia
B
with
factor
IX
inhibitor,
acquired
factor
IX
deficiency
due
to
spontaneous
development of factor IX i