Tamiflu Capsules and Suspension 6mg/ml

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

Oseltamivir phosphate

Հասանելի է:

Roche Products Pty Ltd

Դաս:

Medicine Registered

Ապրանքի հատկությունները

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Tamiflu
®
 PI 6 mg/mL oral suspension and capsules 120119 
_ _

1 of 28 
CDS 10.0

NAME OF THE MEDICINE 

TAMIFLU

 6 MG/ML POWDER FOR ORAL SUSPENSION AND 
CAPSULES 

OSELTAMIVIR PHOSPHATE 

CAS registry number: 204255-11-8 

NH
2
COOC
2
H
5
O
N
H
O
H
3
PO
4
.

The chemical
name (3R,4R,5S)-4-acetylamino-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-
carboxylic acid, ethyl ester, phosphate (1:1).  The chemical formula
is C
16
H
28
N
2
 O
4
 (free 
base).  The molecular weight is 312.4 for oseltamivir free base and
410.4 for oseltamivir 
phosphate salt. 

DESCRIPTION 

Oseltamivir phosphate is a white crystalline solid, highly soluble
in water (> 500 mg/mL). 

TAMIFLU (oseltamivir phosphate) is available as hard capsules for
oral use.  Each 75 mg 
hard capsule of TAMIFLU contains 98.5 mg oseltamivir phosphate,
equivalent to 75 mg of 
oseltamivir.  Each 45 mg hard capsule of TAMIFLU contains 59.1
mg oseltamivir phosphate, 
equivalent to 45 mg of oseltamivir.  Each 30 mg hard capsule of
TAMIFLU contains 39.4 mg 
of oseltamivir phosphate, equivalent to 30 mg of oseltamivir. 

The hard capsules contain the following excipients: starch –
pregelatinised maize, talc, 
povidone K 30, croscarmellose sodium and sodium stearylfumarate.
 The capsule shell 
contains gelatin, titanium dioxide, iron oxide red CI77491, iron
oxide yellow CI77492, iron 
oxide black CI77499, shellac and indigo carmine CI73015. 

TAMIFLU is also available as powder for oral suspension.  Each
bottle, with 13 g powder for 
oral suspension, contains 0.5122 g of oseltamivir phosphate and when
constituted with 55 mL 
water results in a concentration of 6 mg/mL of oseltamivir.  Each
bottle contains the 
following excipients: xanthan gum, sodium dihydrogen citrate,
sodium benzoate, sorbitol, 
saccharin sodium, titanium dioxide and Tutti-Frutti flavouring. 
r

Tamiflu
®
 PI 6 mg/mL oral suspension and capsules 120119 

2 of 28 
CDS 10.0