Daptomycin 350 & 500mg/Vial (EU CTD Q1: 2021)
Product description
Daptomycin 350 & 500mg/Vial Powder for Solution for Injection or Infusion
Reference Product: Cubicin® / MSD Description:Daptomycin is an antibacterial (cyclic lipopeptide natural product) that is active against Gram positive bacteria and is indicated for the treatment of the following infections:Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI). - Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus. It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice.Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB). In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI. Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, Daptomycin should be co administered with appropriate antibacterial agent(s).
Dossier Status: On-going / EU CTD ready to file: Q1 2021
Stability Studies: Zone II / Zone IVb
Shelf life (Originator): Three (3) years
Batch Sizes: 5,434 bottles (350mg) & 9,523 bottles (500mg)
Pack Sizes: BT x 1 vial & BT x 5 vials
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Reference Product: Cubicin® / MSD Description:Daptomycin is an antibacterial (cyclic lipopeptide natural product) that is active against Gram positive bacteria and is indicated for the treatment of the following infections:Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI). - Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus. It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice.Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB). In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI. Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, Daptomycin should be co administered with appropriate antibacterial agent(s).
Dossier Status: On-going / EU CTD ready to file: Q1 2021
Stability Studies: Zone II / Zone IVb
Shelf life (Originator): Three (3) years
Batch Sizes: 5,434 bottles (350mg) & 9,523 bottles (500mg)
Pack Sizes: BT x 1 vial & BT x 5 vials
Specifications
| Categories | APIs (Active Pharmaceutical Ingredients)Antibiotics; Finished Dosage FormsInjectables; Contract Services - Contract ServicesLyophilisation |
|---|---|
| Sales markets | Western Europe; Eastern Europe; Middle East Region (e.g. UAE); Asia; Oceania; North America (USA, Canada); Africa; Central/South America |
| Supplied from | Greece |
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Daptomycin 350 & 500mg/Vial (EU CTD Q1: 2021)
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