Zinforo

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

Ceftaroline fosamil

MAH:

Pfizer Ireland Pharmaceuticals

ATC_code:

J01DI02

INN:

ceftaroline fosamil

therapeutic_group:

Antibacterials for systemic use,

therapeutic_area:

Community-Acquired Infections; Skin Diseases, Infectious; Pneumonia

therapeutic_indication:

Zinforo is indicated for the treatment of the following infections in neonates, infants, children, adolescents and adults: , Complicated skin and soft tissue infections (cSSTI), Community-acquired pneumonia (CAP) , Consideration should be given to official guidance on the appropriate use of antibacterial agents.,

leaflet_short:

Revision: 26

authorization_status:

Authorised

authorization_date:

2012-08-22

PIL

23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZINFORO 600 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
ceftaroline fosamil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zinforo is and what it is used for
2.
What you need to know before you use Zinforo
3.
How to use Zinforo
4.
Possible side effects
5.
How to store Zinforo
6.
Contents of the pack and other information
1.
WHAT ZINFORO IS AND WHAT IT IS USED FOR
WHAT ZINFORO IS
Zinforo is an antibiotic medicine that contains the active substance
ceftaroline fosamil. It belongs to a
group of medicines called ‘cephalosporin antibiotics.’
WHAT ZINFORO IS USED FOR
Zinforo is used to treat children (from birth) and adults with:

infections of the skin and the tissues below the skin

an infection of the lungs called ‘pneumonia’
HOW ZINFORO WORKS
Zinforo works by killing certain bacteria, which can cause serious
infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ZINFORO
DO NOT USE ZINFORO:

If you are allergic to ceftaroline fosamil or any of the other
ingredients of this medicine (listed
in section 6).

If you are allergic to other cephalosporin antibiotics

If you have had previous severe allergic reactions to other
antibiotics like penicillin or
carbapenem.
Do not use Zinforo if any of the above applies to you. If you are not
sure, talk to your doctor or nurse
before using Zinforo.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before using Zinforo:

If you have kidney problems (your doctor may have to prescribe a lower
dose)

If you have ever had fits (seizures or convulsions)

If you have ever had any non-severe allergic reactions to other
a

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zinforo 600 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains ceftaroline fosamil acetic acid solvate monohydrate
equivalent to 600 mg
ceftaroline fosamil.
After reconstitution, 1 mL of the solution contains 30 mg of
ceftaroline fosamil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (powder for
concentrate).
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 in
neonates, infants, children,
adolescents and adults (see sections 4.4 and 5.1):

Complicated skin and soft tissue infections (cSSTI)

Community-acquired pneumonia (CAP)
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
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)
5 – 60
b
/every 12 hours
3
INDICATIONS
POSOLOGY
(MG/INFUSION)
INFUSION TIME
(MINUTES)/FREQUENCY
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
600 mg
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 PAT