PFIZER DAPTOMYCIN daptomycin 350 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

daptomycin, Quantity: 350 mg

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Inhalation, powder for

Composition:

Excipient Ingredients: sodium hydroxide; citric acid

Administration route:

Intravenous

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).,Consideration should be given to official guidance on the appropriate use of antibacterial agents.,Daptomycin is not indicated for the treatment of pneumonia.,Adult patients (?18 years of age):,COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS,PFIZER DAPTOMYCIN is indicated for the treatment of adults (? 18 years of age) with complicated skin and skin structure infections (cSSSI) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONS (BACTERAEMIA),PFIZER DAPTOMYCIN is indicated in adults (?18 years of age) for Staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (RIE), caused by methicillin-susceptible and methicillin-resistant isolates.,The efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to Staphylococcus aureus has not been demonstrated. In the setting of Staphylococcus aureus bacteraemia (SAB), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy.,Paediatric patients (1 to 17 years of age):,Daptomycin is not indicated for treatment of patients less than 1 year of age.,Daptomycin has not been studied in treatment of infective endocarditis in children.,COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS,PFIZER DAPTOMYCIN is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (cSSSI) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONS (BACTERAEMIA),PFIZER DAPTOMYCIN is indicated in paediatric patients (1 to 17 years of age) with Staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. Empiric treatment should be reviewed based on the results of susceptibility testing. Prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of Staphylococcus aureus bacteraemia.

Product summary:

Visual Identification: Light yellow to light brown, lyophilised cake or powder in a Type I Clear Glass Vial with an elastomeric closure and flip off aluminium seal; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2022-03-08

Patient Information leaflet

PFIZER DAPTOMYCIN
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING PFIZER DAPTOMYCIN?
PFIZER DAPTOMYCIN contains the active ingredient daptomycin. PFIZER
DAPTOMYCIN is used to treat complicated infections of
the skin and the tissues under the skin, blood infections and
infections of the tissues that line the inside of the heart (including
heart
valves).
For more information, see Section 1. Why am I using PFIZER DAPTOMYCIN?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PFIZER DAPTOMYCIN?
Do not use if you/your child have had an allergic reaction to
daptomycin or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you/your child have any other medical
conditions, take any other medicines, or if you are pregnant or plan
to
become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use
PFIZER DAPTOMYCIN? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with PFIZER DAPTOMYCIN and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS PFIZER DAPTOMYCIN GIVEN?
PFIZER DAPTOMYCIN will be given to you by a doctor or a nurse as an
injection or infusion into a vein. The dose will depend on
age, bodyweight and the type of infection being treated.
More instructions can be found in Section 4. How do I use PFIZER
DAPTOMYCIN? in the full CMI.
5.
WHAT SHOULD I KNOW DURING TREATMENT WITH PFIZER DAPTOMYCIN?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using PFIZER
DAPTOMYCIN.
•
Tell your doctor if you develop a sore white mouth or tongue; if you
become pregnant; if you develop a
skin rash, difficulty breathing, diarrhoea, aching muscles, muscle
weakness, tingling of the hands/feet,
loss of feeling or difficulties in moving, new or worsening fever

Summary of Product characteristics

Version: pfpdaptv10322
Supersedes: Original
Page 1 of 35
AUSTRALIAN
PRODUCT
INFORMATION
–
PFIZER DAPTOMYCIN (DAPTOMYCIN)
1.
NAME OF THE MEDICINE
Daptomycin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PFIZER DAPTOMYCIN 350 mg powder for injection vial
PFIZER DAPTOMYCIN 500 mg powder for injection vial
Daptomycin is the active ingredient in PFIZER DAPTOMYCIN. It is a
cyclic lipopeptide
antibacterial agent
derived from the fermentation of
_Streptomyces roseosporus_
.
PFIZER DAPTOMYCIN is supplied in a single-dose 15 mL vial, as a
sterile, preservative-
free, light yellow to light brown, lyophilised cake or powder
containing 350 mg or 500 mg
of daptomycin for intravenous (IV) use following reconstitution with
0.9 % sodium chloride
for injection.
Daptomycin has a high aqueous solubility (

1 g/mL).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Powder for injection.
Sterile, preservative-free, light yellow to light brown, lyophilised
cake or powder.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Daptomycin is active against Gram positive bacteria only. In mixed
infections where Gram
negative and/or certain types of anaerobic bacteria are suspected,
Daptomycin should be co-
administered with appropriate antibacterial agent(s).
Consideration should be given to official guidance on the appropriate
use of antibacterial
agents.
Daptomycin is not indicated for the treatment of pneumonia.
Adult patients (≥18 years of age)
_Complicated Skin and Skin Structure Infections_
Version: pfpdaptv10322
Supersedes: Original
Page 2 of 35
PFIZER DAPTOMYCIN is indicated for the treatment of adults (≥ 18
years of age) with
complicated skin and
skin structure infections (cSSSI) who require parenteral therapy and
who have intolerance to
alternative agents (especially penicillin allergy) or who have failed
on other therapy, and when
caused by organisms known to be susceptible to daptomycin.
_Staphylococcus aureus Bloodstream Infections (Bacteraemia)_
PFIZER DAPTOMYCIN is indicated in