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ANFARM HELLAS S.A. sell "Clindamycin Solution for Injection 150mg/ml (EU CTD Available: 2022)"

Basic Information

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Trade Type

Sell

Product Name

Clindamycin Solution for Injection 150mg/ml (EU CTD Available: 2022)

Manufacturer(s)

Specifications

  • Sterility: Sterile solution for injection, meets pharmacopoeial sterility test requirements
  • Particulate Matter: Complies with pharmacopoeial limits for sub-visible particulates in parenteral solutions
  • Container Closure Integrity: 2 mL and 4 mL ampoule presentations validated for container closure integrity

Other Information

Additional Description:

Clindamycin 150mg/ml Solution for Injection (2ml and 4ml ampoules), equivalent to Dalacin/Pfizer. An antibacterial for serious infections caused by susceptible Gram-positive organisms - staphylococci (both penicillinase- and non-penicillinase-producing), streptococci (excluding Streptococcus faecalis), and pneumococci - as well as serious infections from susceptible anaerobic pathogens such as Bacteroides spp, Fusobacterium spp, Propionibacterium spp, Peptostreptococcus spp, and microaerophilic streptococci. It does not cross the blood-brain barrier in therapeutically effective amounts. Dossier status is ongoing, with EU CTD availability in 2022; stability studies cover Zone II/Zone IVb; originator shelf life is two years; batch and pack sizes are to be defined; the originator pack is supplied as boxes of 1, 5 or 10 ampoules.
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