Octanate 250IU Powder and Solvent for Solution for Injection

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

COAGULATION FACTOR VIII (HUMAN)

Διαθέσιμο από:

WELLCHEM PHARMACEUTICALS PTE LTD

Φαρμακολογική κατηγορία (ATC):

B02BD02

Δοσολογία:

250 iu/5 ml

Φαρμακοτεχνική μορφή:

INJECTION, POWDER, FOR SOLUTION

Σύνθεση:

COAGULATION FACTOR VIII (HUMAN) 250 iu/5 ml vial

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES MBH

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

2004-02-06

Φύλλο οδηγιών χρήσης

INSTRUCTIONS FOR USE
(Summary of Product Characteristics)
1     NAME OF THE MEDICINAL PRODUCT
OCTAGAM® 
2    QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1   ACTIVE INGREDIENTS
Human normal immunoglobulin (IVIg)
2.2   QUANTITATIVE COMPOSITION:
1 ml solution contains:
Protein 50 
mg
of which ≥ 95% is human Immunoglobulin G
IgA 
≤ 0.2 mg
Distribution of IgG subclasses:
IgG
1

ca. 60 %
IgG
2

ca. 32 %
IgG
3

ca.   7 %
IgG
4

ca.   1 %
For a full list of excipients, see section 6.1.
3  PHARMACEUTICAL 
FORM
Solution for infusion
4  CLINICAL 
PARTICULARS
4.1   THERAPEUTIC INDICATIONS
_4.1.1  Replacement therapy in:_
•  Primary immunodefi ciency syndromes such as:

- congenital agammaglobulinaemia and hypogammaglobulinaemia

- common variable immunodefi ciency

- severe combined immunodefi ciency

- Wiskott Aldrich syndrome
•  Myeloma or chronic lymphatic leukaemia with severe secondary
hypogammaglobulinaemia and recurrent infections
•  Children with congenital AIDS and recurrent infections.
_4.1.2 Immunomodulation:_
•  Idiopathic thrombocytopenic purpura (ITP) in children or adults
at high risk of bleeding or prior to surgery to correct the 
platelet count.
•  Guillain Barré syndrome
• Kawasaki 
disease
_4.1.3  Allogeneic bone marrow transplantation_
4.2   POSOLOGY AND METHOD OF ADMINISTRATION
_4.2.1 Posology_
The dose and dosage regimen is dependant on the indication.
In replacement therapy the dosage may need to be individualised for
each patient dependant on the pharmacokinetic and 
clinical response.
The following dosage regimens are given as a guideline:
Replacement therapy in primary immunodefi ciency syndromes:
•  The dosage regimen should achieve a trough level of IgG
(measured before the next infusion) of at least 4.0 – 6.0 g/l. 
Three to six months are required after the initiation of therapy for
equilibration to occur. The recommended starting dose 
    is 0.4 - 0.8 g/kg, followed by at least 0.2 g/kg every

Αρχείο Π.Χ.Π.

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_20170202_120_50IU_spc_SG_05.04_en.doc_
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INSTRUCTIONS FOR USE
(SUMMARY OF PRODUCT CHARACTERISTICS)
1
NAME OF THE MEDICINAL PRODUCT
OCTANATE
250 IU powder and solvent for solution for injection
Human Coagulation Factor VIII, freeze-dried
OCTANATE
500 IU powder and solvent for solution for injection
Human Coagulation Factor VIII, freeze-dried
2
COMPOSITION
OCTANATE 250
IU
i s
presented as
pow der
a nd
s olvent
f or
s olution
for
injection
c ontaining
nominally 250 IU human coagulation factor VIII per vial.
T h e
p r o d u c t
c o n t a i n s
a p p r o x i m a t e l y
5 0
I U *
p e r
m l
h u m a n
c o a g u l a t i o n
f a c t o r
V I I I
w h e n
reconstituted with 5 ml of solvent.
OCTANATE
500
IU
i s
pr esented
a s
pow der
a nd
s olvent
f or
s olution
for
i njection
c ontaining
nominally 500 IU human coagulation factor VIII per vial.
T h e
p r o d u c t
c o n t a i n s
a p p r o x i m a t e l y
5 0
I U *
p e r
m l
h u m a n
c o a g u l a t i o n
f a c t o r
V I I I
w h e n
reconstituted with 10 ml of solvent.
For excipients, see 6.1.
* T h e
p o t e n c y
( I U )
i s
d e t e r m i n e d
u s i n g
t h e
E u r o p e a n
P h a r m a c o p o e i a
c h r o m o g e n i c
a ssay.
The
mean specific
a c t i v i t y
o f
OCTANATE is
≥
100 IU/mg protein.
3
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
A white or pale yellow powder or friable solid.
The solvent is a clear, colourless solution.
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_20170202_120_50IU_spc_SG_05.04_en.doc_
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4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment
a nd
pr ophylaxis
of
bl eeding
i n
pa tients
w ith
h aemophilia
A
(congenital
f actor
V III
deficiency).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment should be initiated under the supervision of a physician
experienced in the treatment of
haemophilia. The dosage and duration of the substitution therapy
depend on the severity of factor
VIII deficiency, on the location and extent of the bleeding and on the
patient's clinical condition.
The number of units o f f actor V III