PFIZER DAPTOMYCIN POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500 MGVIAL

Țară: Singapore

Limbă: engleză

Sursă: HSA (Health Sciences Authority)

Ingredient activ:

Daptomycin

Disponibil de la:

PFIZER PRIVATE LIMITED

Codul ATC:

J01XX09

Forma farmaceutică:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Compoziție:

Daptomycin 500mg/vial

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

Prescription Only

Produs de:

Hospira Australia Pty. Ltd.

Statutul autorizaţiei:

ACTIVE

Data de autorizare:

2022-03-10

Caracteristicilor produsului

1.
NAME OF THE MEDICINAL PRODUCT
Pfizer Daptomycin Powder for Solution for Injection or Infusion 500
mg/vial
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 mg daptomycin.
One mL provides 50 mg of daptomycin after reconstitution with 10 mL of
sodium chloride
9 mg/mL (0.9%) solution for injection.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilised powder for solution for injection/infusion.
A light yellow to light brown lyophilised cake or powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Daptomycin is indicated for the treatment of the infections listed
below.
Complicated skin and skin structure infections
Adult (≥ 18 years of age) and paediatric (1 to 17 years of age)
patients with complicated skin
and skin structure infections (cSSSI) caused by susceptible isolates
of the following Gram-
positive bacteria:
_Staphylococcus aureus_
(including methicillin-resistant isolates),
_Streptococcus pyogenes_
,
_Streptococcus agalactiae_
,
_Streptococcus dysgalactiae_
subsp.
_equisimilis_
, and
_Enterococcus faecalis_
(vancomycin-susceptible isolates only).
_Staphylococcus aureus_
bloodstream infections (bacteraemia)
Adult patients (≥ 18 years of age) with
_Staphylococcus aureus_
bloodstream infections
(bacteraemia), including those with right-sided infective endocarditis
(SAB/RIE), caused by
methicillin-susceptible and methicillin-resistant isolates.
Paediatric patients (1 to 17 years of age) with
_S. aureus_
bloodstream infections (bacteraemia)
caused by methicillin-susceptible and methicillin-resistant isolates.
Daptomycin is not indicated for the treatment of left-sided infective
endocarditis due to
_S. aureus_
. The efficacy of daptomycin in patients with left-sided infective
endocarditis due to
_S.aureus_
has not been demonstrated. The clinical study of daptomycin in
patients with
_S. aureus_
bloodstream infections included limited data from patients with
left-sided infective
endocarditis; outcomes in these patients were poor. Daptomycin has not
been