Zinforo

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ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS



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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.



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Table 1 Dosage in adults with normal renal function, creatinine clearance (CrCL)
> 50 mL/min

Indications Posology
(mg/infusion)

Infusion time
(minutes)/Frequency

Standard dosea

Complicated skin and soft tissue infections (cSSTI)

Community-acquired pneumonia (CAP)
600 mg

5 – 60b/every 12 hours

High doseb

cSSTI confirmed or suspected to be caused by S. aureus
with an MIC = 2 mg/L or 4 mg/L to ceftarolinec

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 dosea

Complicated skin and soft 
tissue infections (cSSTI)

Community-acquired 
pneumonia (CAP)

Adolescents aged from 12 
to < 18 years with 
bodyweight ≥ 33 kg

600 mg 5–60b/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

5–60b/every 8 hours

Infants ≥ 2 months to 
< 2 years

8 mg/kg 5–60b/every 8 hours

Neonates from birth to 
< 2 monthsb

6 mg/kg 60/every 8 hours

High doseb

cSSTI confirmed or 
suspected to be caused by 
S. aureus with an 
MIC = 2 mg/L or 4 mg/L 
to ceftarolinec

Children and adolescents 
aged from ≥ 2 years to 
< 18 years

12 mg/kg to a 
maximum of 
600 mg

120/every 8 hours

Infants ≥ 2 months to 
< 2 years 10 mg/kg 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, neonatal 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.
* Calculated using the Schwartz formula (in mL/min/1.73 m2) for paediatric patients.

Special populations

Elderly
No dosage adjustment is required for the elderly with creatinine clearance values > 50 mL/min (see 
section 5.2).



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Renal impairment
The dose should be adjusted when creatinine clearance (CrCL) is ≤ 50 mL/min, as shown in 
Tables 3 and 4 (see section 5.2). The recommended durations of treatment are 5-14 days for cSSTI and 
5-7 days for CAP.

Table 3 Dosage in adults with impaired renal function, creatinine clearance (CrCL) 
≤ 50 mL/min

Indications Creatinine clearance 
(mL/min)a

Posology
(mg/infusion)

Infusion time
(minutes)/Frequency

Standard dose

Complicated skin and soft 
tissue infections(cSSTI)

Community-acquired 
pneumonia (CAP)

> 30 to ≤ 50 400 mg

5–60c/every 12 hours≥ 15 to ≤ 30 300 mg

ESRD, including 
haemodialysisb

200 mg

High dosec

cSSTI confirmed or 
suspected to be caused by 
S. aureus with an 
MIC = 2 mg/L or 4 mg/L 
to ceftarolined

> 30 to ≤ 50 400 mg

120/every 8 hours

≥ 15 to ≤ 30 300 mg

ESRD, including 
haemodialysisb

200 mg

a Calculated using the Cockcroft-Gault formula for adults. Dose is based on CrCL. CrCL should be closely 
monitored and the dose adjusted according to changing renal function.

b Ceftaroline is haemodialyzable; thus Zinforo should be administered after haemodialysis on haemodialysis 
days.

c 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.

d For treatment of S. aureus for which the ceftaroline MIC is ≤ 1 mg/L, the standard dose is recommended.

Dose recommendations for neonates, infants and children and adolescents are based on 
pharmacokinetic (PK) modelling. 

There is insufficient information to recommend dosage adjustments in adolescents aged from 12 to 
< 18 years with bodyweight < 33 kg and in children aged from 2 to 12 years with End-stage renal 
disease (ESRD).

There is insufficient information to recommend dosage adjustments in paediatric patients < 2 years 
with moderate or severe renal impairment or ESRD.

Table 4 Dosage in paediatric patients with impaired renal function, creatinine clearance 
(CrCL) ≤ 50 mL/min

Indications Age group Creatinine 
clearance 
(mL/min)a

Posology
(mg/infusion)

Infusion time
(minutes)/Frequency

Standard dose

Complicated skin 
and soft tissue 
infections (cSSTI)

Adolescents aged 
from 12 to 
< 18 years with 
bodyweight ≥ 33 kg

> 30 to ≤ 50 400 mg 

5–60c/every 12 hours
≥ 15 to ≤ 30 300 mg 
ESRD, 
including 
haemodialysisb

200 mg 

Adolescents aged 
from 12 years to 
< 18 years 

> 30 to ≤ 50
8 mg/kg to a 
maximum of 
300 mg 

5–60c/every 8 hours



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Indications Age group Creatinine 
clearance 
(mL/min)a

Posology
(mg/infusion)

Infusion time
(minutes)/Frequency

Community-
acquired 
pneumonia (CAP)

bodyweight < 33 kg 
and children 
≥ 2 years to 
< 12 years

≥ 15 to ≤ 30
6 mg/kg to a 
maximum of 
200 mg 

High dosec

cSSTI confirmed 
or suspected to be 
caused by S. 
aureus with an 
MIC = 2 mg/L or 
4 mg/L to 
ceftarolined

Children and 
adolescents aged 
from ≥2 years to 
< 18 years 

> 30 to ≤ 50
10 mg/kg to a 
maximum of 
400 mg

120/every 8 hours
≥ 15 to ≤ 30

8 mg/kg to a 
maximum of 
300 mg

a Calculated using the Schwartz formula for paediatric patients (in mL/min/1.73 m2). Dose is based on CrCL. 
CrCL should be closely monitored and the dose adjusted according to changing renal function.

b Ceftaroline is haemodialyzable; thus Zinforo should be administered after haemodialysis on haemodialysis 
days.

c 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.

d For treatment of S. aureus for which the ceftaroline MIC is ≤ 1 mg/L, the standard dose is recommended.

Hepatic impairment
No dosage adjustment is considered necessary in patients with hepatic impairment (see section 5.2).

Method of administration
Intravenous use. Zinforo is administered by intravenous infusion over 5 to 60 minutes for standard 
dose or 120 minutes for high dose (for cSSTI caused by S. aureus with MIC of 2 or 4 mg/L to 
ceftaroline) in infusion volumes of 50 mL, 100 mL or 250 mL (see section 6.6). Infusion related 
reactions (such as phlebitis) can be managed by prolonging the infusion duration.

Infusion volumes for paediatric patients will vary according to the weight of the child. The infusion 
solution concentration during preparation and administration should not exceed 12 mg/mL ceftaroline 
fosamil.

For instructions on reconstitution and dilution of the medicinal product before administration, see 
section 6.6.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Hypersensitivity to the cephalosporin class of antibacterials.
Immediate and severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam 
antibacterial agent (e.g. penicillins or carbapenems).

4.4 Special warnings and precautions for use

Hypersensitivity reactions
Serious and occasionally fatal hypersensitivity reactions are possible (see sections 4.3 and 4.8).

Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic 
epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and 
acute generalised exanthematous pustulosis (AGEP) have been reported in association with
beta-lactam antibiotics (including cephalosporins) treatment.



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Patients who have a history of hypersensitivity to cephalosporins, penicillins or other beta-lactam 
antibacterials may also be hypersensitive to ceftaroline fosamil. Ceftaroline should be used with 
caution in patients with a history of non-severe hypersensitivity reactions to any other beta-lactam 
antibiotics (e.g. penicillins or carbapenems). If a severe allergic reaction or SCAR occurs during 
treatment with Zinforo, the medicinal product should be discontinued and appropriate measures taken.

Clostridium difficile-associated diarrhoea 
Antibacterial-associated colitis and pseudomembranous colitis have been reported with ceftaroline 
fosamil and may range in severity from mild to life threatening. Therefore, it is important to consider 
this diagnosis in patients who present with diarrhoea during or subsequent to the administration of 
ceftaroline fosamil (see section 4.8). In such circumstance, the discontinuation of therapy with 
ceftaroline fosamil and the use of supportive measures together with the administration of specific 
treatment for Clostridium difficile should be considered.

Non-susceptible organisms
Superinfections may occur during or following treatment with Zinforo.

Patients with pre-existing seizure disorder 
Seizures have occurred in toxicology studies at 7-25 times human ceftaroline Cmax levels (see
section 5.3). Clinical study experience with ceftaroline fosamil in patients with pre-existing seizure 
disorders is very limited. Therefore, Zinforo should be used with caution in this patient population. 

Direct antiglobulin test (Coombs test) seroconversion and potential risk of haemolytic anaemia
The development of a positive direct antiglobulin test (DAGT) may occur during treatment with 
cephalosporins. The incidence of DAGT seroconversion in patients receiving ceftaroline fosamil was 
11.2% in the five pooled pivotal studies with administration every 12 hours (600 mg administered over 
60 minutes every 12 hours) and 32.3% in a study in patients receiving ceftaroline fosamil every 
8 hours (600 mg administered over 120 minutes every 8 hours), (see section 4.8). In clinical studies 
there was no evidence of haemolysis in patients who developed a positive DAGT on treatment. 
However, the possibility that haemolytic anaemia may occur in association with cephalosporins 
including Zinforo treatment cannot be ruled out. Patients experiencing anaemia during or after 
treatment with Zinforo should be investigated for this possibility.

Limitations of the clinical data
There is no experience with ceftaroline in the treatment of CAP in the following patient groups: the 
immunocompromised, patients with severe sepsis/septic shock, severe underlying lung disease, those 
with PORT Risk Class V, and/or CAP requiring ventilation at presentation, CAP due to methicillin-
resistant S. aureus or patients requiring intensive care. Caution is advised when treating such patients. 

There is no experience with ceftaroline in the treatment of cSSTI in the following patient groups: the 
immunocompromised, patients with severe sepsis/septic shock, necrotizing fasciitis, perirectal abscess 
and patients with third degree and extensive burns. There is limited experience in treating patients with 
diabetic foot infections. Caution is advised when treating such patients.

There are limited clinical trial data on the use of ceftaroline to treat cSSTI caused by S. aureus with an 
MIC of > 1 mg/L. The recommended dosages of Zinforo shown in Tables 1 to 4 for the treatment of 
cSSTI caused by S. aureus with ceftaroline MIC of 2 or 4 mg/L are based on pharmacokinetic-
pharmacodynamic modelling and simulation (see sections 4.2 and 5.1). Zinforo should not be used to 
treat cSSTI due to S. aureus for which the ceftaroline MIC is > 4 mg/L.

The recommended dosage of Zinforo shown in Table 2 for paediatric patients < 2 months of age are 
based on pharmacokinetic-pharmacodynamic modelling and simulation.

Infusion times of less than 60 minutes are based on pharmacokinetic and pharmacodynamic analyses 
only.



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4.5 Interaction with other medicinal products and other forms of interaction

No clinical drug-drug interaction studies have been conducted with ceftaroline fosamil.

The interaction potential of ceftaroline or ceftaroline fosamil on medicinal products metabolised by 
CYP450 enzymes is expected to be low since they are not inhibitors nor inducers of CYP450 enzymes 
in vitro. Ceftaroline or ceftaroline fosamil are not metabolised by CYP450 enzymes in vitro, therefore 
co-administered CYP450 inducers or inhibitors are unlikely to influence the pharmacokinetics of 
ceftaroline.

Ceftaroline is neither a substrate, nor an inhibitor of renal uptake transporters (OCT2, OAT1, and 
OAT3) in vitro. Therefore, interactions of ceftaroline with medicinal products that are substrates or 
inhibitors (e.g. probenecid) of these transporters would not be expected.

Paediatric population
As with adults, the interaction potential is expected to be low in paediatrics.

4.6 Fertility, pregnancy and lactation

Pregnancy
There are no or limited amount of data from the use of ceftaroline fosamil in pregnant women. Animal 
studies conducted in rat and rabbit do not indicate harmful effects with respect to reproductive toxicity 
at exposures similar to therapeutic concentrations. Following administration throughout pregnancy and 
lactation in the rat, there was no effect on pup birth weight or growth, although minor changes in 
foetal weight and delayed ossification of the interparietal bone were observed when ceftaroline 
fosamil was administered during organogenesis (see section 5.3). 

As a precautionary measure, it is preferable to avoid the use of Zinforo during pregnancy unless the 
clinical condition of the woman requires treatment with an antibiotic with Zinforo’s antibacterial 
profile.

Breast-feeding
It is unknown whether ceftaroline fosamil or ceftaroline is excreted in human milk. A risk to the 
newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding 
or to discontinue/abstain from Zinforo therapy taking into account the benefit of breast-feeding for the 
child and the benefit of therapy for the woman.

Fertility
The effects of ceftaroline fosamil on fertility on humans have not been studied. Animal studies with 
ceftaroline fosamil do not indicate harmful effects with respect to fertility (see section 5.3).

4.7 Effects on ability to drive and use machines

Undesirable effects e.g. dizziness may occur and this may have an effect on the ability to drive and use 
of machines (see section 4.8).



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4.8 Undesirable effects

Summary of the safety profile

The most common adverse reactions occurring in ≥ 3% of approximately 3242 patients treated with 
Zinforo in clinical studies were diarrhoea, headache, nausea, and pruritus, and were generally mild or 
moderate in severity.  Clostridium difficile-associated disease (CDAD) and severe hypersensitivity
reactions may also occur.

A greater incidence of rash in Asian patients (see below) and a greater incidence of DAGT 
seroconversion (see section 4.4) were observed in a study of adult patients with cSSTI conducted with 
Zinforo 600 mg administered over 120 minutes every 8 hours.  

Tabulated list of adverse reactions

The following adverse reactions have been identified during clinical trials and post-marketing 
experience with Zinforo. Adverse reactions are classified according to System Organ Class and 
frequency. Frequency categories are derived according to the following conventions: very common 
(≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to 
< 1/1,000), not known (cannot be estimated from the available data).

Table 5 Frequency of adverse reactions by system organ class from clinical trials and post-
marketing experience

System organ 
class

Very 
common

Common Uncommon Rare

Infections and 
infestations

Clostridium 
difficile colitis (see 
section 4.4)

Blood and 
lymphatic 
system 
disorders

Anaemia, 
leucopenia, 
neutropenia, 
thrombocytopenia, 
prothrombin time 
(PT) prolonged, 
activated partial 
thromboplastin 
time (aPTT) 
prolonged, 
international 
normalized ratio 
(INR) increased

Agranulocytosis, 
eosinophilia

Immune 
system 
disorders

Rash, pruritus Anaphylaxis, 
hypersensitivity 
(e.g. urticaria, lip 
and face swelling) 
(see sections 4.3 
and 4.4)

Nervous 
system 
disorders

Headache, 
dizziness

Vascular 
disorders

Phlebitis



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System organ 
class

Very 
common

Common Uncommon Rare

Gastrointestin
al disorders

Diarrhoea, 
nausea, 
vomiting, 
abdominal 
pain

Hepatobiliary
disorders

Increased 
transaminases

Renal and 
urinary 
disorders

Blood creatinine
increased

General 
disorders and 
administration 
site conditions

Pyrexia, 
infusion site 
reactions 
(erythema, 
phlebitis, 
pain)

Investigations Coombs 
Direct Test 
Positive 
(see 
section 4.4)

Description of selected adverse reactions

Severe Cutaneous Adverse Reactions
SCARs (Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and
systemic symptoms, acute generalised exanthematous pustulosis) have been reported with beta-lactam 
antibiotics, including cephalosporins (see section 4.4).

Rash
Rash was observed at a common frequency in both the pooled Phase III studies in cSSTI with 
administration of Zinforo every 12 hours (600 mg administered over 60 minutes every 12 hours) and 
the study in cSSTI with administration every 8 hours (600 mg administered over 120 minutes every 
8 hours). However, the frequency of rash in the subgroup of Asian patients receiving Zinforo every 
8 hours was very common (18.5%).

Paediatric population

The safety assessment in paediatric patients is based on the safety data from 2 trials in which 227
patients aged from 2 months to 17 years with cSSTI or CAP received Zinforo. Overall, the safety 
profile in these 227 patients was similar to that observed in the adult population.

In addition, the safety assessment in neonates is based on the safety data from 2 trials in which 
34 patients (age range from birth to less than 60 days) received Zinforo; 23 of these patients received 
only a single dose of Zinforo. Overall, the adverse events reported in these studies were consistent 
with the known safety profile for Zinforo.



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Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V.

4.9 Overdose

Limited data in patients receiving higher than recommended Zinforo dosages show similar adverse 
reactions as observed in the patients receiving recommended dosages. Relative overdosing could occur 
in patients with moderate renal impairment. Treatment of overdose should follow standard medical 
practice;

Ceftaroline can be removed by haemodialysis; over a 4 hour dialysis period, approximately 74% of a 
given dose was recovered in the dialysate.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antibacterials for systemic use, other cephalosporins and penems, ATC 
code: J01DI02

The active moiety after Zinforo administration is ceftaroline.

Mechanism of action

Ceftaroline is a cephalosporin antibacterial with in vitro activity against Gram-positive and -negative 
bacteria. The bactericidal action of ceftaroline is mediated through binding to essential penicillin-
binding proteins (PBPs). Biochemical studies have shown that ceftaroline has high affinity for PBP2a 
of methicillin-resistant Staphylococcus aureus (MRSA) and PBP2x of penicillin non-susceptible 
Streptococcus pneumoniae (PNSP).  As a result, minimum inhibitory concentrations (MICs) of 
ceftaroline against a proportion of these organisms tested fall into the susceptible range (see 
Resistance section below).

Resistance

Ceftaroline is not active against strains of Enterobacterales producing extended-spectrum beta-
lactamases (ESBLs) from the TEM, SHV or CTX-M families, serine carbapenemases (such as KPC), 
class B metallo-beta-lactamases or class C (AmpC) cephalosporinases. Organisms that express these 
enzymes and which are therefore resistant to ceftaroline occur at very variable rates between countries 
and between healthcare facilities within countries. If ceftaroline is commenced before susceptibility 
test results are available then local information on the risk of encountering organisms that express 
these enzymes should be taken into consideration. Resistance may also be mediated by bacterial 
impermeability or drug efflux pump mechanisms. One or more of these mechanisms may co-exist in a 
single bacterial isolate.

Interaction with other antibacterial agents

In vitro studies have not demonstrated any antagonism between ceftaroline in combination with other 
commonly used antibacterial agents (e.g. amikacin, azithromycin, aztreonam, daptomycin, 
levofloxacin, linezolid, meropenem, tigecycline, and vancomycin).

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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Susceptibility testing breakpoints

The European Committee on Antimicrobial Susceptibility Testing (EUCAST) breakpoints for 
susceptibility testing are presented below.

Organisms MIC breakpoints (mg/L) 
Susceptible (≤ S) Resistant (R>)

Staphylococcus aureus 11 22

Streptococcus pneumoniae 0.25 0.25
Streptococcus Groups A, B, C, G Note3 Note3

Haemophilus influenzae 0.03 0.03
Enterobacterales 0.5 0.5

1. Refers to dosing of adults or adolescents (from 12 years and 33 kg) with ceftaroline every 12 hours using 1-
hour infusions (see section 4.2). Note that: There are no clinical trial data regarding the use of ceftaroline to 
treat CAP due to S. aureus with ceftaroline MICs > 1 mg/L

2. Refers to dosing of adults or adolescents (from 12 years and 33 kg) with ceftaroline every 8 hours using 2-

hour infusions to treat cSSTI (see section 4.2). S. aureus with ceftaroline MICs ≥ 4 mg/L are rare. PK-PD 

analyses suggest that dosing of adults or adolescents (from 12 years and 33 kg) with ceftaroline every 8 

hours using 2-hour infusions may treat cSSTI due to S. aureus for which the ceftaroline MIC is 4 mg/L.
3. Infer susceptibility from susceptibility to benzylpenicillin.

Pharmacokinetic/pharmacodynamic relationship
As with other beta-lactam antimicrobial agents, the percent time above the minimum inhibitory 
concentration (MIC) of the infecting organism over the dosing interval (%T > MIC) has been shown to 
be the parameter that best correlates with the efficacy of ceftaroline.

Clinical efficacy against specific pathogens
Efficacy has been demonstrated in clinical studies against the pathogens listed under each indication 
that were susceptible to ceftaroline in vitro.

Complicated skin and soft tissue infections
Gram-positive micro-organisms
 Staphylococcus aureus (including methicillin-resistant strains)
 Streptococcus pyogenes 
 Streptococcus agalactiae 
 Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus)
 Streptococcus dysgalactiae 

Gram-negative micro-organisms
 Escherichia coli
 Klebsiella pneumoniae 
 Klebsiella oxytoca 
 Morganella morganii 

Community-acquired pneumonia
No cases of CAP due to MRSA were enrolled into the studies. The available clinical data cannot 
substantiate efficacy against penicillin non-susceptible strains of S. pneumoniae.

Gram-positive micro-organisms
 Streptococcus pneumoniae
 Staphylococcus aureus (methicillin-susceptible strains only)



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Gram-negative micro-organisms
 Escherichia coli
 Haemophilus influenzae 
 Haemophilus parainfluenzae 
 Klebsiella pneumoniae

Antibacterial activity against other relevant pathogens

Clinical efficacy has not been established against the following pathogens although in vitro studies 
suggest that they would be susceptible to ceftaroline in the absence of acquired mechanisms of 
resistance:

Anaerobic micro-organisms
Gram-positive micro-organisms
 Peptostreptococcus spp. 

Gram-negative micro-organisms
 Fusobacterium spp.

In vitro data indicate that the following species are not susceptible to ceftaroline: 
 Chlamydophila spp.
 Legionella spp.
 Mycoplasma spp.
 Proteus spp.
 Pseudomonas aeruginosa

5.2 Pharmacokinetic properties

The Cmax and AUC of ceftaroline increase approximately in proportion to dose within the single dose 
range of 50 to 1000 mg. No appreciable accumulation of ceftaroline is observed following multiple 
intravenous infusions of 600 mg every 8 or 12 hours in healthy adults with CrCL > 50 mL/min.

Distribution

The plasma protein binding of ceftaroline is low (approximately 20%) and ceftaroline is not 
distributed into erythrocytes. The median steady-state volume of distribution of ceftaroline in healthy 
adult males following a single 600 mg intravenous dose of radiolabelled ceftaroline fosamil was 
20.3 l, similar to the volume of extracellular fluid.

Biotransformation

Ceftaroline fosamil (prodrug) is converted into the active ceftaroline in plasma by phosphatase 
enzymes and concentrations of the prodrug are measurable in plasma primarily during intravenous 
infusion. Hydrolysis of the beta-lactam ring of ceftaroline occurs to form the microbiologically 
inactive, open-ring metabolite, ceftaroline M-1. The mean plasma ceftaroline M-1 to ceftaroline AUC 
ratio following a single 600 mg intravenous infusion of ceftaroline fosamil in healthy subjects is 
approximately 20-30%.

In pooled human liver microsomes, metabolic turnover was low for ceftaroline, indicating that 
ceftaroline is not metabolised by hepatic CYP450 enzymes.



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Elimination

Ceftaroline is primarily eliminated by the kidneys. Renal clearance of ceftaroline is approximately 
equal, or slightly lower than the glomerular filtration rate in the kidney, and in vitro transporter studies 
indicate that active secretion does not contribute to the renal elimination of ceftaroline.

The mean terminal elimination half-life of ceftaroline in healthy adults is approximately 2.5 hours.

Following the administration of a single 600 mg intravenous dose of radiolabelled ceftaroline fosamil 
to healthy male adults, approximately 88% of radioactivity was recovered in urine and 6% in faeces.

Special populations

Renal impairment
Dosage adjustments are required in adults, adolescents and children with CrCL ≤ 50 mL/min (see 
section 4.2).

There is insufficient information to recommend dosage adjustments in adolescents with ESRD aged 
from 12 to < 18 years and with bodyweight < 33 kg and in children with ESRD aged from 2 to 
< 12 years. There is insufficient information to recommend dosage adjustments in paediatric patients
aged < 2 years with moderate or severe renal impairment or ESRD.

Hepatic impairment
The pharmacokinetics of ceftaroline in patients with hepatic impairment has not been established. As 
ceftaroline does not appear to undergo significant hepatic metabolism, the systemic clearance of 
ceftaroline is not expected to be significantly affected by hepatic impairment. Therefore, no dosage 
adjustment is recommended for patients with hepatic impairment.

Elderly
Following administration of a single 600 mg intravenous dose of ceftaroline fosamil, the 
pharmacokinetics of ceftaroline were similar between healthy elderly subjects (≥ 65 years of age), and 
healthy young adult subjects (18-45 years of age). There was a 33% increase in AUC0-∞ in the elderly 
that was mainly attributable to age-related changes in renal function. Zinforo dose adjustment is not 
required in elderly patients with creatinine clearance above 50 mL/min.

Paediatric population
Dose adjustments are required for neonates, infants, children and adolescents with bodyweight < 33 kg 
(see section 4.2). 

5.3 Preclinical safety data

The kidney was the primary target organ of toxicity in both the monkey and rat. Histopathologic 
findings included pigment deposition and inflammation of the tubular epithelium. Renal changes were 
not reversible but were reduced in severity following a 4 week recovery period.

Convulsions have been observed at relatively high exposures during single and multi-dose studies in 
both the rat and monkey (≥ 7 times to the estimated ceftaroline Cmax level of a 600 mg twice a day).

Other important toxicologic findings noted in the rat and monkey included histopathologic changes in 
the bladder and spleen.



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Genetic toxicology
Ceftaroline fosamil and ceftaroline were clastogenic in an in vitro chromosomal aberration assay, 
however there was no evidence of mutagenic activity in an Ames test, mouse lymphoma and 
unscheduled DNA synthesis assay. Furthermore, in vivo micronucleus assays in rat and mouse were 
negative. Carcinogenicity studies have not been conducted.

Reproductive toxicology
Overall, no adverse effects on fertility or post-natal development were observed in the rat at up to 
5 times the observed clinical exposure. When ceftaroline was administered during organogenesis, 
minor changes in foetal weight and delayed ossification of the interparietal bone were observed in the 
rat at exposures below that observed clinically. However, when ceftaroline was administered 
throughout pregnancy and lactation, there was no effect on pup weight or growth. Ceftaroline 
administration to pregnant rabbits resulted in an increased foetal incidence of angulated hyoid alae, a 
common skeletal variation in rabbit fetuses, at exposures similar to those observed clinically.

Juvenile toxicity
Intravenous bolus dosing of ceftaroline fosamil to suckling rats from post-natal day 7 to 20 was well 
tolerated at plasma exposures approximately 2-fold higher than those for paediatric patients. Renal 
cortical cysts were oberved in all groups, including controls, on PND50. The cysts involved a small 
portion of the kidney and ocurred in the absence of significant changes in either renal function or 
urinary parameters. Therefore, these findings were not considered to be adverse.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Arginine

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in 
section 6.6.

6.3 Shelf life

Dry powder: 3 years

After reconstitution:
The reconstituted vial should be diluted immediately.

After dilution:
Once the intravenous solution is prepared with diluents listed in section 6.6 it should be administered 
within 6 hours of preparation. The chemical and physical in-use stability has been demonstrated for up 
to 24 hours at 2-8 °C. Once removed from refrigeration to room temperature, the diluted product must 
be used within 6 hours.

From a microbiological point of view, the medicinal product should be used immediately. If not used 
immediately, in-use storage times and conditions prior to use are the responsibility of the user and 
would normally not be longer than 24 hours at 2 to 8ºC, unless reconstitution/dilution has taken place 
in controlled and validated aseptic conditions.



15

6.4 Special precautions for storage

Store below 30 °C.
Store in the original package in order to protect from light.
For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5 Nature and contents of container

20 mL glass vial (Type 1) closed with a rubber (halobutyl) stopper and aluminium seal with flip-off 
cap.

The medicinal product is supplied in packs of 10 vials.

6.6 Special precautions for disposal and other handling

The powder must be reconstituted with water for injections and the resulting concentrate must then be 
immediately diluted prior to use. The reconstituted solution is a pale yellow solution that is free of any 
particles.

Standard aseptic techniques should be used for solution preparation and administration.

Zinforo powder should be reconstituted with 20 mL of sterile water for injections. The resulting 
solution should be shaken prior to being transferred to an infusion bag or bottle containing either 
sodium chloride 9 mg/mL (0.9%) solution for injection, dextrose 50 mg/mL (5%) solution for 
injection, sodium chloride 4.5 mg/mL and dextrose 25 mg/mL solution for injection (0.45% sodium 
chloride and 2.5% dextrose) or Lactated Ringer’s solution. A 250 mL, 100 mL or 50 mL infusion bag 
can be used to prepare the infusion, based on the patient’s volume requirements. The total time 
interval between starting reconstitution and completing preparation of the intravenous infusion should 
not exceed 30 minutes.

Infusion volumes for paediatric patients will vary according to the weight of the child. The infusion 
solution concentration during preparation and administration should not exceed 12 mg/mL ceftaroline 
fosamil.

Each vial is for single use only.

Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements.

7. MARKETING AUTHORISATION HOLDER

Pfizer Ireland Pharmaceuticals
Operations Support Group
Ringaskiddy, County Cork
Ireland

8. MARKETING AUTHORISATION NUMBER(S) 

EU/1/12/785/001



16

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 23 August 2012
Date of the latest renewal: 24 April 2017

10. DATE OF REVISION OF THE TEXT

Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu.

http://www.ema.europa.eu/


17

ANNEX II

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH 
RELEASE

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 
AND USE

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 
THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT



18

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer(s) responsible for batch release

ACS Dobfar S.p.A.
Nucleo Industriale S. Atto 
64100 Teramo
Italy

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

Medicinal product subject to medical prescription.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION

 Periodic Safety Update Reports

The requirements for submission of periodic safety update reports for this medicinal product are 
set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of 
Directive 2001/83/EC and any subsequent updates published on the European medicines web-
portal.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT  

 Risk Management Plan (RMP)
The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed 
RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of 
the RMP.

An updated RMP should be submitted:
 At the request of the European Medicines Agency;
 Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as a result of an 
important (pharmacovigilance or risk minimisation) milestone being reached.



19

ANNEX III

LABELLING AND PACKAGE LEAFLET



20

A. LABELLING



21

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Zinforo 600 mg powder for concentrate for solution for infusion
ceftaroline fosamil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each vial contains ceftaroline fosamil acetic acid solvate monohydrate equivalent to 600 mg 
ceftaroline fosamil.

3. LIST OF EXCIPIENTS

Arginine

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for concentrate for solution for infusion.
10 vials

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.
Intravenous use.
For single use only.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE  SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP



22

9. SPECIAL STORAGE CONDITIONS

Store below 30 °C.
Store in the original package in order to protect from light.
See leaflet for shelf life after reconstitution.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Pfizer Ireland Pharmaceuticals
Operations Support Group
Ringaskiddy, County Cork
Ireland

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/12/785/001

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:
SN:
NN:



23

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

VIAL LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Zinforo 600 mg powder for concentrate 
ceftaroline fosamil
IV

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER



24

B. PACKAGE LEAFLET



25

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 antibiotics like penicillin or 

carbapenem



26

 If you have had severe diarrhoea whilst taking antibiotics in the past

You may get another infection caused by another bacteria during or following treatment with Zinforo.

You may develop signs and symptoms of severe skin reactions such as fever, joint pain, skin rash, red 
scaly rash, skin bumps that contain pus, blisters or peeling of skin, red circular patches often with 
central blisters on the trunk, ulcers of mouth, throat, nose, genitals and eyes. If this happens talk to 
your doctor or nurse immediately.

Lab Test
You may develop an abnormal lab test (called Coombs test) that looks for certain antibodies which 
may act against your red blood cells. If the level of your red blood cells fall your doctor may check to 
see if these antibodies have caused this.

If any of the above apply to you (or you are not sure), talk to your doctor or nurse before using 
Zinforo.

Other medicines and Zinforo
Tell your doctor or nurse if you are using, have recently used or might use any other medicines. 

Pregnancy and breast-feeding
Tell your doctor before using Zinforo if you are pregnant. Do not use this medicine during pregnancy 
unless your doctor has told you to.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor for advice before taking this medicine.

Driving and using machines
Zinforo may cause side effects such as dizziness. This may impair your ability to drive or operate 
machinery.

3. How to use Zinforo

Zinforo will be given to you by a doctor or nurse. 

How much to use
The usual recommended dose for adults is 600 mg every 12 hours. Your doctor may increase your 
dose to 600 mg every 8 hours for some infections. The usual recommended dose for children depends 
on the age and weight of the child and is given every 8 or 12 hours. It is given as a drip into a vein 
lasting 5 to 60 minutes if you receive the usual dose or 120 minutes if you receive an increased dose. 

A course of treatment usually lasts for 5 to 14 days for skin infections and 5 to 7 days for pneumonia.

Patients with kidney problems
If you have kidney problems your doctor may lower your dose because Zinforo is removed from your 
body by the kidneys.

If you use more Zinforo than you should
If you think you have been given too much Zinforo, tell your doctor or nurse straight away.

If you miss a dose of Zinforo
If you think you have missed a dose, tell your doctor or nurse straight away.

If you have any further questions on the use of this medicine, ask your doctor or nurse.



27

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The 
following side effects may happen with this medicine:

Tell your doctor straight away if you get these symptoms as you may need urgent medical 
treatment:
 Sudden swelling of your lips, face, throat or tongue; a severe rash; and, swallowing or breathing 

problems. These may be signs of a severe allergic reaction (anaphylaxis) and may be life-
threatening;

 Diarrhoea that becomes severe or does not go away or stool that contains blood or mucus during 
or after treatment with Zinforo. In this situation, you should not take medicines that stop or slow 
bowel movement.

Very common (may affect more than 1 in 10 people)
 Changes in a blood test called a ‘Coombs test’ commonly seen in patients receiving this type of 

antibiotic. This test looks for certain antibodies which may act against your red blood cells.

Common (may affect up to 1 in 10 people)
 Fever
 Headache
 Feeling dizzy
 Itching, skin rash
 Diarrhoea, stomach pain
 Feeling sick (nausea) or being sick (vomiting)
 More enzymes produced by your liver (as shown in blood tests)
 Pain and irritation of the veins
 Redness, pain or swelling where the injection was given.

Uncommon (may affect up to 1 in 100 people)
 Anaemia
 Raised itchy rash (hives)
 An increase in the level of creatinine in your blood. Creatinine shows how well your kidneys are 

working.
 Bleeding or bruising more than usual. This may be because the level of platelets in your blood 

has dropped.
 Changes in tests which measure how well your blood clots.
 A decrease in the total number of white blood cells, ora certain type of white blood cells in your 

blood (leucopenia and neutropenia).

Rare (may affect up to 1 in 1,000 people)
 A significant decrease in the number of certain white blood cells in your blood 

(agranulocytosis). You may experience fever, flu-like symptoms, sore throat, or any other
infection which may be serious.

 An increase in the number of certain white blood cells in your blood (eosinophilia).

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not 

listed in this leaflet. You can also report side effects directly via the national reporting system listed in 

Appendix V. By reporting side effects you can help provide more information on the safety of this 

medicine.

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


28

5. How to store Zinforo

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the container. The expiry date refers 
to the last day of that month.

Store below 30°C.

Store in the original package in order to protect from light.

Medicines should not be disposed of via wastewater or household waste. The hospital will dispose of 
any waste materials safely. These measures will help to protect the environment.

6. Contents of the pack and other information

What Zinforo contains 
 Each vial contains 600 mg of ceftaroline fosamil.
 The other ingredient is arginine.

What Zinforo looks like and contents of the pack
Zinforo is a pale yellowish-white to light yellow powder for concentrate for solution for infusion in a 
vial. It is available in packs containing 10 vials.

Marketing Authorisation Holder 

Pfizer Ireland Pharmaceuticals
Operations Support Group
Ringaskiddy, County Cork
Ireland

Manufacturer

ACS Dobfar S.p.A.
Nucleo Industriale S. Atto
64100 Teramo
Italy

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder:

België/Belgique/Belgien
Pfizer S.A./N.V.
Tél/Tel: +32 (0)2 554 62 11

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel. +3705 2514000

България
Пфайзер Люксембург САРЛ, Клон България 
Тел.: +359 2 970 4333

Luxembourg/Luxemburg
Pfizer S.A.
Tél/Tel: +32 (0)2 554 62 11

Česká republika
Pfizer spol s r.o.
Tel: +420-283-004-111

Magyarország
PFIZER Kft. 
Tel. + 36 1 488 37 00 



29

Danmark
Pfizer ApS
Tlf: +45 44 20 11 00

Malta
Vivian Corporation Ltd.
Tel: +35621 344610

Deutschland
Pfizer Pharma PFE GmbH
Tel: +49 (0)800 8535555

Nederland
Pfizer bv
Tel: +31 (0)10 406 43 01

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Ελλάδα
Pfizer ΕΛΛΑΣ Α.Ε.
Τηλ.: +30 210 67 85 800

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

España
Pfizer, S.L.
Tel: +34 91 490 99 00

Polska
Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00

France
Pfizer 
Tél: +33 (0)1 58 07 34 40

Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 5500

Hrvatska
Pfizer Croatia d.o.o.
Tel: + 385 1 3908 777

România
Pfizer România S.R.L.
Tel: +40 (0)21 207 28 00

Ireland
Pfizer Healthcare Ireland
Tel: +1800 633 363 (toll free) 
+44 (0)1304 616161

Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja 
farmacevtske dejavnosti, Ljubljana
Tel: + 386 (0)1 52 11 400

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: +421–2–3355 5500

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Suomi/Finland
Pfizer PFE Finland Oy
Puh./Tel: +358 (0)9 43 00 40

Κύπρος
Pfizer ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH)
Τηλ: +357 22 817690

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: +371 670 35 775

United Kingdom
Pfizer Limited
Tel: +44 (0) 1304 616161

This leaflet was last revised in 



30

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.

---------------------------------------------------------------------------------------------------------------------------

The following information is intended for medical or healthcare professionals only:

Important: Please refer to the Summary of Product Characteristics before prescribing.

Aseptic technique must be followed in preparing the infusion solution. The contents of Zinforo vial 
should be reconstituted with 20 mL of sterile water for injections. Instructions for the reconstitution of 
Zinforo vial are summarized below:

Dosage strength
(mg)

Volume of diluent
to be added

(mL)

Approximate ceftaroline 
concentration

(mg/mL)

Amount to be 
withdrawn

600 20 30 Total volume

The reconstituted solution must be further diluted to produce Zinforo solution for infusion. A 250 mL, 
100 mL or 50 mL infusion bag can be used to prepare the infusion, based on the patient’s volume 
requirements. Appropriate infusion diluents include: sodium chloride 9 mg/mL (0.9%) solution for 
injection, dextrose 50 mg/mL (5%) solution for injection, sodium chloride 4.5 mg/mL and dextrose 
25 mg/mL solution for injection (0.45% sodium chloride and 2.5% dextrose) or Lactated Ringer’s 
solution. The resulting solution should be administered according to the dose selected over 5 to
60 minutes for standard dose or 120 minutes for high dose in infusion volumes of 50 mL, 100 mL or 
250 mL.

Infusion volumes for paediatric patients will vary according to the weight of the child. The infusion 
solution concentration during preparation and administration should not exceed 12 mg/mL ceftaroline 
fosamil.

Reconstitution time is less than 2 minutes. Mix gently to reconstitute and check to see that the contents 
have dissolved completely. Parenteral drug products should be inspected visually for particulate matter 
prior to administration.

The colour of Zinforo infusion solutions ranges from clear, light to dark yellow depending on the 
concentration and storage conditions. It is free of any particles. When stored as recommended, the 
product potency is not affected.

Studies have shown that Zinforo solutions for infusion are stable for up to 6 hours at room 
temperature. Alternatively they are stable for up to 24 hours under refrigerated storage. Once removed
from refrigeration to room temperature, the diluted product must be used within 6 hours.

From a microbiological point of view, the medicinal product should be used immediately unless 
reconstitution and dilution has taken place in controlled and validated aseptic conditions. If not used 
immediately, in-use storage times and conditions prior to use are the responsibility of the user.

The compatibility of Zinforo with other medicines has not been established. Zinforo should not be 
mixed with or physically added to solutions containing other drugs.

Each vial is for single use only. 

Any unused product or waste material should be disposed of in accordance with local requirements.

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETINGAUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE ANDEFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET