Zinforo Powder for Concentrate for Solution for Infusion 600mgvial

Երկիր: Սինգապուր

Լեզու: անգլերեն

Աղբյուրը: HSA (Health Sciences Authority)

Ակտիվ բաղադրիչ:

CEFTAROLINE FOSAMIL 600 mg EQV CEFTAROLINE

Հասանելի է:

PFIZER PRIVATE LIMITED

ATC կոդը:

J01DI02

Դոզան:

530 mg/vial

Դեղագործական ձեւ:

INJECTION, POWDER, FOR SOLUTION

Կազմը:

CEFTAROLINE FOSAMIL 600 mg EQV CEFTAROLINE 530 mg/vial

Կառավարման երթուղին:

INTRAVENOUS

Ռեկվիզորի տեսակը:

Prescription Only

Պատրաստված է:

ACS Dobfar S.p.A.

Լիազորման կարգավիճակը:

ACTIVE

Հաստատման ամսաթիվը:

2012-11-15

Տեղեկատվական թերթիկ

01/AC/SG/INF.000-090-859.3.0 

Zinforo
™

600mg Powder for Concentrate for Solution for Infusion 

ceftaroline fosamil 
1. 
NAME OF THE MEDICINAL PRODUCT 

Zinforo
™

(ceftaroline fosamil) powder for concentrate for solution for
infusion, IV, 600 mg 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each vial contains ceftaroline fosamil 600 mg equivalent to
ceftaroline 530 mg. 

For excipients, see section 6.1 

3. 
PHARMACEUTICAL FORM 

Powder for concentrate for solution for infusion 

A pale yellowish-white to light yellow powder 

4. 
CLINICAL PARTICULARS 
4.1 
THERAPEUTIC INDICATIONS  

Zinforo is indicated for the treatment of adult (≥ 18 years of age)
patients with the following 
infections caused by susceptible isolates of the designated
microorganisms: 

•
  Complicated skin and soft tissue infections  
•
  Community-acquired pneumonia  

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION  

The recommended dosage of Zinforo is 600 mg administered every 12
hours by intravenous 
infusion over 60 minutes in patients ≥ 18 years of age. The
duration of treatment should be 
guided by the type of infection to be treated, its severity, and the
patient’s clinical response. 

Recommended dosage and administration by infections is as follows: 
INFECTION DOSAGE 
FREQUENCY 
INFUSION 
TIME 
(MINUTES) 
RECOMMENDED DURATION 
OF ANTIMICROBIAL 
TREATMENT 
Complicated skin and soft 
tissue infections (cSSTI) 
600 mg  every 12 hours 
60 
5-14 days 
Community-acquired 
pneumonia (CAP) 
600 mg  every 12 hours 
60 
5-7 days 

SPECIAL POPULATIONS 
PATIENTS WITH RENAL IMPAIRMENT 
The following dose adjustment is recommended in patients with renal
impairment (see 
sections 4.4 and 5.2):  

ESTIMATED CREATININE CLEARANCE (ML/MIN) 
RECOMMENDED DOSAGE REGIMEN 
> 30 to ≤ 50 
400 mg intravenously (over 60 minutes) every 
12 hours 
≤ 30 and End-stage renal disease 
Insufficient

Ապրանքի հատկությունները

ZINFORO
® 600 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
ceftaroline fosamil
1.
NAME OF THE MEDICINAL PRODUCT
Zinforo
®
(ceftaroline fosamil) powder for concentrate for solution for
infusion, IV, 600 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains ceftaroline fosamil 600 mg equivalent to
ceftaroline 530 mg.
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion. A pale
yellowish-white to light yellow
powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zinforo is indicated for the treatment of the following infections
caused by susceptible isolates
of the designated microorganisms:
•
Complicated skin and soft tissue infections (cSSTI)
•
Community-acquired pneumonia (CAP)
Zinforo is indicated in neonates, infants, children, adolescents and
adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended durations of treatment are 5-14 days for cSSTI and 5-7
days for CAP.
TABLE 1
DOSAGE IN ADULTS WITH NORMAL RENAL FUNCTION, CREATININE CLEARANCE
(CRCL)
>50 ML/MIN
INDICATIONS
POSOLOGY
(MG/INFUSION)
INFUSION TIME
(MINUTES)/FREQUENCY
Standard dose
a
Complicated skin and soft tissue infections (cSSTI)
Community-acquired pneumonia (CAP)
600 mg
5 – 60
b
/every 12 hours
High dose
b
cSSTI
confirmed or suspected to be caused by
_S. aureus_ with an MIC = 2 mg/L or 4 mg/L to
ceftaroline
c
120/every 8 hours
a
For patients with supranormal renal clearance receiving the standard
dose, an infusion time of 60 minutes
may be preferable.
b
Infusion times of less than 60 minutes and high dose recommendations
are based on pharmacokinetic and
pharmacodynamic analyses only. See sections 4.4 and 5.1.
c
For treatment of _S. aureus_ for which the ceftaroline MIC is ≤1
mg/L, the standard dose is recommended.
TABLE 2
DOSAGE IN PAEDIATRIC PATIENTS WITH NORMAL RENAL FUNCTION, CREATININE
CLEARANCE
(CRCL) >50 ML/MIN
*
INDICATIONS
AGE GROUP
POSOLOGY
(MG/INFUSION)
INFUSION TIME
(MINUTES)/FREQUENCY
Standard dose
a
Complicated skin and soft
tissue