DAPTOMYCIN WKT daptomycin 350 mg powder for injection vial

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

daptomycin, Quantity: 350 mg

Disponível em:

Wockhardt Bio Pty Ltd

Forma farmacêutica:

Injection, powder for

Composição:

Excipient Ingredients: sodium hydroxide

Via de administração:

Intravenous

Unidades em pacote:

1 vial

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

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 WKT 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 WKT 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 WKT 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 WKT 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.

Resumo do produto:

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

Status de autorização:

Registered

Data de autorização:

2023-02-20

Folheto informativo - Bula

DAPTOMYCIN WKT POWDER FOR INJECTION CMI V 1.3 ( Nov 2022)
Page
1
of
6
DAPTOMYCIN WKT
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 WKT?
DAPTOMYCIN WKT 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 WKT? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN DAPTOMYCIN WKT?
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 WKT?
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 WKT GIVEN?
DAPTOMYCIN WKT 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 WKT given?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN DAPTOMYCIN WKT?
THINGS YOU
SHOULD DO
Remind any doctor, dentist or pharmacist you visit that you are using
DAPTOMYCIN WKT
Tell your doctor if any of the following occur:-
•
the symptoms of your infection

Características técnicas

DAPTOMYCIN WKT V1.5 Feb 2023
Page
1
of
31
AUSTRALIAN PRODUCT INFORMATION –
DAPTOMYCIN WKT
(DAPTOMYCIN)
1
NAME OF THE MEDICINE
Daptomycin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DAPTOMYCIN WKT 350 mg powder for injection
DAPTOMYCIN WKT 500 mg powder for injection
DAPTOMYCIN WKT 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 WKT 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 WKT 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.
DAP