ADVATE 1000 IU Powder and Solvent for Solution for Injection

Riik: Singapur

keel: inglise

Allikas: HSA (Health Sciences Authority)

Toimeaine:

rFVIII Octocog Alfa

Saadav alates:

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

ATC kood:

B02BD02

Annus:

1000 IU

Ravimvorm:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Koostis:

rFVIII Octocog Alfa 1000 IU

Manustamisviis:

INTRAVENOUS

Retsepti tüüp:

Prescription Only

Valmistatud:

Takeda Manufacturing Austria AG

Volitamisolek:

ACTIVE

Loa andmise kuupäev:

2008-07-16

Infovoldik

(d) whether your body may build up antibodies to this medicine. After
a while your body
may build up these antibodies, leading to a less effective treatment
than the usual.
ADVATE is usually administered in a hospital. However, some
individuals may be trained
to use this product at home.
_HOW OFTEN IT IS GIVEN_:
Your doctor will tell you how often and what intervals ADVATE is to be
administered.
Usually, a substitution therapy, such as ADVATE, is a lifetime
treatment. Although no
overdose adverse effect has been reported with ADAVATE, if you have
used this product
more often than you should, you must tell your doctor.
_IF YOU MISS/FORGET YOUR INJECTION: _
Proceed with the next administration immediately, and continue at
regular intervals as
advised by your doctor. Do not take a double dose to make up the
forgotten dose.
_HOW IT IS GIVEN:_
ADVATE  is  intended  for  intravenous  injection  only  and
 must  be  administered  within
3  hours  after  reconstitution.  Aseptic  conditions  (meaning
 clean  and  germ  free)  are
required during the reconstitution and administration. Use only the
medical devices for
reconstitution and administration provided with each package of 250
IU, 500 IU, 1000 IU
and 1500 IU.
(SEE, INSTRUCTION FOR USE)
ADVATE must not be mixed with other infusion solutions. It is to be
used in one patient
on one occasion only.
_CASE OF OVERDOSE_
No symptoms of overdose with ADVATE
 have been reported
_WHILE YOU ARE BEING TREATED WITH ADVATE_
Discuss  with  your  doctor  the  progress  you  have
 experienced  after  the  treatment,
especially during the first few days. As ADVATE is given in a
hospital, your healthcare
professional will take records of the progress and unexpected
reactions.
_SIDE EFFECTS_
As with any medicine, some side effects may occur. Some patients may
have sudden
signs of allergy. Your doctor is aware of this potential adverse
effect, in particular as the
active ingredient in ADVATE is a protein.
Adverse  reactions  that  have  been  repo

Toote omadused

Technical Info
Dieline
NA
NA
NA
CODE 3 OF 9
DATAMATRIX CODE
RSS / GS1-128 CODE
BODY TEXT SIZE
8.0 pt
NA
CODE ITF 2/5
3615
PHARMACODE
NA
GTIN / EAN-13 CODE
BACK
PANTONE 259 C
TECHNICAL SPECIFICATION:
ARTWORK DIMENSIONS/SIZE:
ITEM NUMBER:
FRONT
LE-07-56947
VERSION: 2
PROFILE: 0400374_1_PIL_Drwg
LE0400374
310 x 446 mm
GRAPHICS HOUSE:
SGK Redmond
DATE:
02MAR2022
OPTIONAL: Artwork Approver outside the Shire Management System:
ROLE:
NAME:
SIGNATURE:
DATE:
Black
Swatch
Swatch
Black
Swatch
Swatch
Swatch
PRODUCT INFORMATION
NAME OF THE DRUG:
ADVATE 250 IU, 500 IU, 1000 IU, 1500 IU
CHEMICAL NAME:
Recombinant Coagulation Factor VIII (rch)
INN: Octocog Alfa
Laboratory Code: Recombinant Antihaemophilic FVIII,
Plasma/Albumin Free Method (rAHF-PFM)
COMPOSITION:
Table 1: UNIT FORMULATION
Powder for intravenous injection, after
reconstitution with Sterile Water for Injection to
5 mL. The amounts of the inactive ingredients are
constant in all strengths.
ADVATE
250 IU
500 IU
1000 IU
1500 IU
ACTIVE INGREDIENT
Octocog alfa
[Recombinant Coagulation FVIII (rch)]
250 IU
500 IU
1000 IU
1500 IU
Inactive Ingredient:
(mg)
(mg)
(mg)
(mg)
Trehalose
40.0
40.0
40.0
40.0
Histidine
8.0
8.0
8.0
8.0
Trometamol
6.0
6.0
6.0
6.0
Sodium Chloride
26.5
26.5
26.5
26.5
Calcium Chloride
1.0
1.0
1.0
1.0
Glutathione (reduced)
0.4
0.4
0.4
0.4
Polysorbate 80
0.5
0.5
0.5
0.5
Mannitol
160.0
160.0
160.0
160.0
DESCRIPTION
ADVATE is formulated as a sterile, non-pyrogenic, white to off-white,
lyophilised powder preparation of Recombinant Antihaemophilic
Factor VIII. It is produced from a genetically engineered Chinese
Hamster
Ovary (CHO) cell-line under conditions, which are free from the use of
animal derived protein. ADVATE (rAHF-PFM) is presented in a glass vial
accompanied by sterile Water for Injection (5 mL) for reconstitution
(see DOSAGE AND ADMINISTRATION). The reconstituted product is a clear,
colourless solution for intravenous (IV) injection. After
reconstitution, the
product contains 0.45 mmol (10 mg) sodium per vial.
Trehalose, a disaccharide of two glu