VIEKIRA PAK-RBV paritaprevir/ritonavir/ombitasvir 75mg/50mg/12.5mg tabs and dasabuvir (as sodium salt) 250mg tabs and ribavirin

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

dasabuvir sodium monohydrate,ombitasvir,paritaprevir,Ribavirin,Ritonavir

Disponible desde:

Abbvie Pty Ltd

Designación común internacional (DCI):

dasabuvir sodium monohydrate,ombitasvir,paritaprevir,Ribavirin,Ritonavir

Ficha técnica

VIEKIRA PAK-RBV
Version 07
21 March 2017
1
of 57
PRODUCT INFORMATION
VIEKIRA PAK-RBV COMBINATION THERAPY PACK
NAME OF THE MEDICINE
VIEKIRA PAK-RBV is a composite pack containing
paritaprevir/ritonavir/ombitasvir 75/50/12.5 mg
tablets, dasabuvir 250 mg tablets and 200 mg, 400 mg or 600 mg
ribavirin tablets.
Refer to DOSAGE AND ADMINISTRATION for populations requiring
ribavirin.
CHEMICAL STRUCTURE AND DESCRIPTION OF EACH ACTIVE PHARMACEUTICAL
INGREDIENT
PARITAPREVIR
Paritaprevir drug substance is manufactured as a dihydrate; however,
it is dehydrated during the
drug
product
manufacturing
process
and
is
amorphous
and
anhydrous
in
the
final
product.
Paritaprevir dihydrate is chemically designated
(2_R_,6_S_,12_Z_,13a_S_,14a_R_,16a_S_)-_N_- (Cyclopropylsulfonyl)-
6-{[(5-methylpyrazin-2-yl)carbonyl]amino}-5,16-dioxo-2-(phenanthridin-6-yloxy)-
1,2,3,6,7,8,9,10,11,13a,14,15,16,16atetradecahydrocyclopropa[_e_]pyrrolo[1,2-_a_][1,4]
diazacyclopentadecine-14a(5_H_)-carboxamide dihydrate.
The molecular formula is C
40
H
43
N
7
O
7
S•2H
2
O (dihydrate) and the molecular weight for the drug
substance is 801.91 (dihydrate). Paritaprevir dihydrate has the
following structural formula:
CAS Number: 1456607-71-8
Paritaprevir dihydrate is a white to off-white powder with very low
water solubility. Paritaprevir
dihydrate has a pKa of 4.6 at 25°C.
RITONAVIR
Ritonavir
is
chemically
designated
as
[5_S_-(5_R_*,8_R_*,10_R_*,11_R_*)]10-Hydroxy-2-methyl-5-(1-
methyethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmehyl)-2,4,7,12-
tetraazatridecan-13-oic acid,5-thiazolylmethyl ester.
The molecular formula is C
37
H
48
N
6
O
5
S
2
and the molecular weight is 720.95.
VIEKIRA PAK-RBV
Version 07
21 March 2017
2
of 57
Ritonavir has the following structural formula:
CAS Number: 155213-67-5
Ritonavir is a white to light tan powder practically insoluble in
water and freely soluble in methanol
and ethanol. Ritonavir has a pKa of 2.8.
OMBITASVIR
Ombitasvir drug substance is manufactured as a hydrate; however, it is
dehydrated during