DAPTOMYCIN WOCKHARDT daptomycin 500 mg powder for injection vial

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

daptomycin, Quantity: 500 mg

제공처:

Wockhardt Bio Pty Ltd

약제 형태:

Injection, powder for

구성:

Excipient Ingredients: sodium hydroxide

관리 경로:

Intravenous

패키지 단위:

1 vial

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

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 WOCKHARDT 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 WOCKHARDT 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 (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 WOCKHARDT 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 WOCKHARDT 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.

제품 요약:

Visual Identification: pale yellow to light brown freeze dried powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

승인 상태:

Registered

승인 날짜:

2023-02-20

환자 정보 전단

DAPTOMYCIN WOCKHARDT POWDER FOR INJECTION CMI V 1.3 (NOV2022)
Page
1
of
6
DAPTOMYCIN WOCKHARDT
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 WOCKHARDT?
DAPTOMYCIN WOCKHARDT contains the active ingredient daptomycin which
is used to treat complicated infections of the skin
and the tissues under the skin in adults and children (1 to 17 years
of age). It is also used to treat 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
being given DAPTOMYCIN WOCKHARDT? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN DAPTOMYCIN WOCKHARDT?
Do not use if you have ever had an allergic reaction to daptomycin or
any of the ingredients listed at the end of the CMI. You
should not be given daptomycin if you have or have had any kidney
problems, are suffering from diarrhoea. 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 WOCKHARDT? in
the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with 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 DAPTOMYCIN WOCKHARDT GIVEN?
DAPTOMYCIN WOCKHARDT will be given to you by a doctor or a nurse as it
needs to be given as an injection or infusion into
a vein. The dose will depend on how much you weigh and the type of
infection being treated. More instructions can be found
in Section 4. How is DAPTOMYCIN WOCKHARDT given in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN DAPTOMYCIN WOCKHARDT?
THINGS YOU
SHOULD DO
Remind any doctor, dentist or pharmacist you visit that you are using
DAPTOMYCIN WOCKHARDT
Tell your docto

제품 특성 요약

DAPTOMYCIN WOCKHARDT V1.5 Feb 2023
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AUSTRALIAN PRODUCT INFORMATION –
DAPTOMYCIN WOCKHARDT
(DAPTOMYCIN)
1
NAME OF THE MEDICINE
Daptomycin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DAPTOMYCIN WOCKHARDT 350 mg powder for injection
DAPTOMYCIN WOCKHARDT 500 mg powder for injection
DAPTOMYCIN WOCKHARDT is supplied in a single-dose -15 mL capacity
vial, as 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 for injection.
Daptomycin has a high aqueous solubility (
>
1 g/mL).
The only inactive ingredient is sodium hydroxide, which is used in
minimal quantities for pH
adjustment.
3
PHARMACEUTICAL FORM
Powder for injection.
Sterile, preservative-free, pale yellow to light brown, lyophilised
cake or powder.
4
CLINICAL PARTICULARS
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 _
DAPTOMYCIN WOCKHARDT 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 WOCKHARDT 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-susce