ADVATE 500 IU Powder and Solvent for Solution for Injection

País: Cingapura

Língua: inglês

Origem: HSA (Health Sciences Authority)

Ingredientes ativos:

rFVIII Octocog Alfa

Disponível em:

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

Código ATC:

B02BD02

Dosagem:

500 IU

Forma farmacêutica:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Composição:

rFVIII Octocog Alfa 500 IU

Via de administração:

INTRAVENOUS

Tipo de prescrição:

Prescription Only

Fabricado por:

Takeda Manufacturing Austria AG

Status de autorização:

ACTIVE

Data de autorização:

2008-07-16

Folheto informativo - Bula

ADVATE
 [Antihaemophilic Factor VIII (Recombinant), Plasma/Albumin-Free
Method] 
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.  
Trehalose, a disaccharide of two glucose molecules

Características técnicas

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