DAPTOMYCIN ACCORD daptomycin 500 mg powder for injection vial

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

daptomycin, Quantity: 500 mg

Доступно од:

Accord Healthcare Pty Ltd

Фармацеутски облик:

Injection, powder for

Састав:

Excipient Ingredients: sodium hydroxide

Пут администрације:

Intravenous

Јединице у пакету:

1

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

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,Daptomycin Accord 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),Daptomycin Accord 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 Accord therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy (see Section 4.4 Special Warnings and Precautions for Use).,Paediatric patients (1 to 17 years of age),Daptomycin is not indicated for treatment of patients less than 1 year of age (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use).,Daptomycin has not been studied in treatment of infective endocarditis in children (see Section 5.1 Pharmacodynamic Properties, Clinical trials and Section 4.4 Special Warnings and Precautions for Use).,Complicated Skin and Skin Structure Infections,Daptomycin Accord 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),Daptomycin Accord 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.

Резиме производа:

Visual Identification: A pale yellow to light brown lyophilised cake or powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Статус ауторизације:

Registered

Датум одобрења:

2020-03-24

Информативни летак

Daptomycin Accord – version 2.0
1
DAPTOMYCIN ACCORD
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 BEING GIVEN DAPTOMYCIN ACCORD?
Daptomycin Accord is used in adults and children (1 to 17 years of
age) to treat complicated infections of the skin and the
tissues under the skin. It is also used to treat blood infections. It
is also used in adults to treat infections of the tissues that line
the inside of the heart (including heart valves) - that are caused by
Staphylococcus aureus bacteria.
For more information, see Section 1. Why am I using Daptomycin Accord?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN DAPTOMYCIN ACCORD?
Do not use if you have ever had an allergic reaction to any medicine
containing daptomycin or any of the ingredients listed at
the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given Daptomycin Accord?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Daptomycin Accord 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 WILL I BE GIVEN DAPTOMYCIN ACCORD?
Daptomycin Accord will be given to you by a doctor or nurse as it
needs to be given as in injection or infusion into a vein.
More instructions can be found in Section 4. How will I be given
Daptomycin Accord? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN DAPTOMYCIN ACCORD?
THINGS YOU
SHOULD DO
•
If the symptoms of your infection do not improve, or if they become
worse, tell your doctor.
•
If you develop itching with swelling or skin rash or difficulty
breathing while you are being given
Daptomycin Accord tell your doctor immediately.
•
Tell our doctor that you are being treate

Карактеристике производа

Page 1 of 25
AUSTRALIAN PRODUCT INFORMATION
DAPTOMYCIN ACCORD
(DAPTOMYCIN) POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Daptomycin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial contains 350 mg or 500 mg of daptomycin.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Powder for injection.
Daptomycin Accord is a sterile, preservative-free, pale 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 injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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
Daptomycin Accord 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)
Daptomycin Accord 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 end