CPhI Online

Pipeline - Clindamycin Product Profile

13 Apr 2021

Clindamycin 150mg/ml Solution for Injection (2ml & 4ml Amp) Dalacin® / Pfizer

Antibacterial.  Serious infections caused by susceptible Gram-positive organisms, staphylococci (both penicillinase- and non-penicillinase-producing), streptococci (except Streptococcus faecalis) and pneumococci.
It is also indicated in serious infections caused by susceptible anaerobic pathogens such as Bacteroides spp, Fusobacterium spp, Propionibacterium spp, Peptostreptococcus spp. and microaerophilic streptococci.
Clindamycin does not penetrate the blood/brain barrier in therapeutically effective quantities.
Dossier Status: On-going / EU CTD Available: 2022
Stability Studies: Zone II / Zone IVb
Shelf life (Originator):   Two (2) years
Batch Sizes: To be defined
Pack Sizes: To be defined   
Originator pack: Box x 1, 5 & 10 Ampoules.