New carbetocin RTS formulation
|
Current carbetocin refrigerated formulation (Duratocin®, Ferring)a
|
---|
Component
|
Amount (mg/mL)
|
Function
|
Component
|
Amount (mg/mL
|
Function
|
---|
Carbetocin
|
0.100
|
Active substance
|
Carbetocin
|
0.100
|
Active substance
|
Succinic acid
|
1.19
|
Buffer
|
Sodium chloride
|
9
|
Isotonicity agent
|
Mannitol
|
47.0
|
Isotonicity agent
|
Glacial acetic acid
|
to pH 3.8
|
pH adjustment
|
L-methionine
|
1.00
|
Antioxidant
|
Water for injection
|
1.0 mL
|
Solvent
|
Sodium hydroxide 2 N
|
to pH 5.45
|
pH adjustment
|
--
|
--
|
--
|
Water for injection
|
1.0 mL
|
Solvent
|
--
|
--
|
--
|
-
aCarbetocin 100 μg/mL was first approved in Canada in June 1997 and is currently registered in more than 70 countries under the trade names PABAL/DURATOCIN/LONACTENE/DURATOBAL
-
RTS room temperature stable