DAPTOMYCIN PANPHARMA daptomycin 350 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

daptomycin

Available from:

Panpharma Australia Pty Ltd

Authorization status:

Registered

Patient Information leaflet

Daptomycin Panpharma
Version 1.4
1
DAPTOMYCIN PANPHARMA
DAPTOMYCIN POWDER FOR SOLUTION FOR INJECTION 350 MG AND 500 MG_ _
_Daptomycin (pronounced DAP-toe-My-sin) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Daptomycin
Panpharma. 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 it is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT DAPTOMYCIN
PANPHARMA IS USED FOR
_WHAT IT IS USED FOR _
Daptomycin Panpharma 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. 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.
Daptomycin Panpharma will not work
against infections that cause
pneumonia (a serious infection or
inflammation in the lung tissue).
_ _
_ _
_HOW DAPTOMYCIN PANPHARMA _
_WORKS _
Daptomycin Panpharma 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
PANPHARMA 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 Panpharma is not
addictive.
BEFORE YOU HAVE
DAPTOMYCIN
PANPHARMA
_WHEN YOU MUST NOT HAVE IT _
YOU MUST NOT HAVE DAPTOMYCIN
PANPHARMA 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 symptom

Summary of Product characteristics

Product Information
Page 1
Daptomycin Panpharma (350 mg & 500 mg)
Version 1.0
AUSTRALIAN PRODUCT INFORMATION – DAPTOMYCIN
PANPHARMA (DAPTOMYCIN) POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Daptomycin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Daptomycin 350 mg powder for injection.
Daptomycin Panpharma 350 mg contains 350 mg daptomycin. One mL
provides 50 mg of
daptomycin after reconstitution with 7 mL of sodium chloride 9 mg/mL
(0.9%) solution.
Daptomycin 500 mg powder for injection.
Daptomycin Panpharma 500 mg contains 500 mg daptomycin. One mL
provides 50 mg of
daptomycin after reconstitution with 10 mL of sodium chloride 9 mg/mL
(0.9%) solution.
Daptomycin is the active ingredient in Daptomycin Panpharma. It is a
cyclic lipopeptide
antibacterial agent derived from the fermentation of
_Streptomyces roseosporus_
.
Active ingredient:
daptomycin
Chemical names:
_N_
-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-
ornithyl-L-aspartyl-D-alanyl-L- aspartylglycyl-D-seryl-
_threo_
-3-
methyl-L-
glutamyl-3-
anthraniloyl-L-alanine
Ɛ1
-lactone
Molecular weight:
1620.67
Molecular formula
C
72
H
101
N
17
O
26
Daptomycin Panpharma is supplied in a single-use 15 mL vial, as a
sterile, preservative-free, pale
yellow to light brown, lyophilised cake or powder containing at least
900 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.
3
PHARMACEUTICAL FORM
Powder for injection.
Sterile, preservative-free, pale yellow to light brown, lyophilised
cake or powder.
Product Information
Page 2
Daptomycin Panpharma (350 mg & 500 mg)
Version 1.0
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 ant