Zinforo

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ceftaroline fosamil 600mg equivalent to Ceftaroline fosamil acetic acid solvate monohydrate 668.4 mg

Available from:

Pfizer New Zealand Limited

INN (International Name):

Ceftaroline fosamil 600 mg (equivalent to Ceftaroline fosamil acetic acid solvate monohydrate 668.4 mg)

Dosage:

600 mg

Pharmaceutical form:

Powder for injection

Composition:

Active: Ceftaroline fosamil 600mg equivalent to Ceftaroline fosamil acetic acid solvate monohydrate 668.4 mg Excipient: Arginine

Units in package:

Vial, glass, 20 mL Type 1 with halobutyl rubber closure and flip off aluminium seal, 10 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

ACS Dobfar SpA

Therapeutic indications:

Zinforo is indicated for the treatment of patients with the following infections proven or strongly suspected to be caused by the designated susceptible bacteria: - 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.

Product summary:

Package - Contents - Shelf Life: Vial, glass, 20 mL Type 1 with halobutyl rubber closure and flip off aluminium seal - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 6 hours reconstituted stored at or below 25°C

Authorization date:

2012-12-12

Summary of Product characteristics

Version: pfdzinfi10923
Supersedes: pfdzinfi10123
Page 1 of 23
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
Zinforo
®
600 mg powder for injection.
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 List of excipients.
3. PHARMACEUTICAL FORM
Powder for injection.
Zinforo is a sterile, pyrogen-free pale yellowish-white to light
yellow powder.
The reconstituted, diluted solution is a pale yellow solution that is
free of any particles.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zinforo
is indicated for the treatment of patients with the following
infections proven or
strongly suspected to be caused by the designated susceptible bacteria
(see Sections 4.4
Special warnings and precautions for use and 5.1 Pharmacodynamic
properties):
•
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 DOSE AND METHOD OF ADMINISTRATION
DOSE
The recommended dosage, the frequency and infusion times are
summarised in Table 1
below. The duration of treatment should be guided by the type of
infection to be treated, its
severity, and the patient’s clinical response.
Version: pfdzinfi10923
Supersedes: pfdzinfi10123
Page 2 of 23
TABLE 1: DOSAGE IN PATIENTS WITH NORMAL RENAL FUNCTION, CREATININE
CLEARANCE (CRCL)
>50 ML/MIN)*
INFECTION/DURATION
OF TREATMENT
AGE GROUP
DOSAGE
INFUSION TIME/
FREQUENCY
STANDARD DOSE
cSSTI
a
/Duration of
treatment is 5 – 14
days
Adults and adolescents
aged from 12 to
< 18 years with
bodyweight ≥ 33 kg
600 mg
5
b
– 60 min every
12 hours
Adolescents aged from
12 years to < 18 years
bodyweight < 33 kg
AND
children ≥ 2 years to
< 12 years
12 mg/kg to a
maximum of
400 mg
5
b
– 60 mins every 8
hours
b
≥ 2 months to < 2 years
8 mg/k