DAPTOMYCIN JUNO 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:

Juno Pharmaceuticals Pty Ltd

Forma farmacêutica:

Injection, powder for

Composição:

Excipient Ingredients: sodium hydroxide; water for injections; nitrogen

Via de administração:

Intravenous, Intravenous Infusion

Unidades em pacote:

1

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Daptomycin is indicated for:,The treatment of adults and paediatric patients (1 to 17 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.,Daptomycin is also indicated in adults 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,- 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 coadministered 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

Resumo do produto:

Visual Identification: pale yellow to light brown, sterile lyophilised powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; 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:

2019-04-23

Folheto informativo - Bula

DAPTOMYCIN JUNO CMI v0.1
1
DAPTOMYCIN JUNO
POWDER FOR SOLUTION FOR INJECTION
_daptomycin (pronounced DAP-toe-MY-sin)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DAPTOMYCIN
JUNO. It does not contain all the
available information. It does not take
the place of talking to your doctor or
pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking this medicine against the
benefits they expect it will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again
WHAT DAPTOMYCIN
JUNO IS USED FOR
_WHAT IT IS USED FOR_
DAPTOMYCIN JUNO 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 in adults to treat blood
infections or infections of the tissues
that line the inside of the heart
(including heart valves) - that are
caused by Staphylococcus aureus
bacteria.
DAPTOMYCIN JUNO will not work
against infections that cause
pneumonia (a serious infection or
inflammation in the lung tissue).
_HOW DAPTOMYCIN JUNO _
_WORKS _
DAPTOMYCIN JUNO is an antibiotic
that belongs to a group of medicines
called cyclic lipopeptides. These
antibiotics work by killing the Gram-
positive bacteria that are causing your
infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
DAPTOMYCIN JUNO HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another purpose.
This medicine is available only with a
doctor's prescription.
DAPTOMYCIN JUNO is not
addictive.
BEFORE YOU HAVE
DAPTOMYCIN JUNO
_ _
_WHEN YOU MUST NOT HAVE IT_
YOU MUST NOT HAVE DAPTOMYCIN
JUNO IF YOU ARE ALLERGIC
(HYPERSENSITIVE) TO DAPTOMYCIN, THE
ACTIVE INGREDIENT, OR TO ANY OF THE
OTHER INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Some of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathing; swelling of the face, lips,
tongue or other p

Características técnicas

Australian Product Information
Juno Pharmaceuticals Pty Ltd
Page | 1
Daptomycin JUNO PI v 1.1
AUSTRALIAN PRODUCT INFORMATION
_DAPTOMYCIN JUNO _
_DAPTOMYCIN _
_ _
1 NAME OF THE MEDICINE
Daptomycin
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
DAPTOMYCIN JUNO is supplied in a single-use 10 mL vial, as a sterile,
preservative-free,
pale yellow to light brown, lyophilised cake or powder containing at
least 500 mg/g of
daptomycin for intravenous (IV) use following reconstitution with 0.9
% sodium chloride
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.
For the full list of excipients, see SECTION 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Powder for injection.
Sterile, preservative-free, pale yellow to light brown, lyophilised
cake or powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DAPTOMYCIN JUNO is indicated for the treatment of adults and
paediatric patients (1 to 17
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.
Daptomycin is also indicated in adults 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).
Daptomycin is active against Gram positive bac