AZITH azithromycin (as monohydrate) 500 mg powder for injection vial

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

azithromycin, Quantity: 500 mg (Equivalent: azithromycin monohydrate, Qty 512.029 mg)

Tilgængelig fra:

Alphapharm Pty Ltd

INN (International Name):

Azithromycin

Lægemiddelform:

Injection, powder for

Sammensætning:

Excipient Ingredients: sodium hydroxide; citric acid

Indgivelsesvej:

Intravenous Infusion

Enheder i pakken:

1 vial or 5 vials

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

Community acquired pneumonia caused by susceptible organisms in patients who require initial intravenous therapy. In clinical studies efficacy has been demonstrated against Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophilia, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus and Streptococcus pneumoniae.

Produkt oversigt:

Visual Identification: White powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Autorisation status:

Licence status A

Autorisation dato:

2009-06-01

Indlægsseddel

AZITH
_azithromycin (as monohydrate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about AZITH.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking AZITH against
the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT AZITH IS USED
FOR
AZITH is an antibiotic which
contains azithromycin as the active
ingredient. Azithromycin belongs to
a group of medicines called azalides
which are a sub-class of a group of
antibiotics called macrolides.
AZITH is used to treat pneumonia, a
lung infection caused by certain
bacteria such as Legionella
pneumophila.
AZITH works by killing or stopping
the growth of bacteria causing the
infection.
It will not work against viral
infections such as colds or flu.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY AZITH HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
This medicine is available only with
a doctor's prescription.
There is no evidence that it is
addictive.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN AZITH IF
YOU HAVE EVER HAD AN ALLERGIC
REACTION TO:
•
azithromycin
•
any other ketolide or macrolide
antibiotic (e.g. roxithromycin,
erythromycin, clarithromycin,
telithromycin)
•
any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction
may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
AZITH MUST NOT BE GIVEN TO
CHILDREN.
The safety and effectiveness of this
medicine in children has not been
established.
AZITH MUST NO

Produktets egenskaber

AUSTRALIAN PRODUCT INFORMATION
AZITH
_Azithromycin (as monohydrate) powder for intravenous injection _
1
NAME OF THE MEDICINE
Azithromycin (as monohydrate).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each AZITH 500 mg vial contains azithromycin monohydrate as active
ingredient equivalent to 500 mg
Azithromycin, providing 100 mg/mL solution following reconstitution..
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Powder for injection for infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Community acquired pneumonia caused by susceptible organisms in
patients who require initial
intravenous therapy. In clinical studies efficacy has been
demonstrated against
_Chlamydia pneumoniae, _
_Haemophilus influenzae, Legionella pneumophilia, Moraxella
catarrhalis, Mycoplasma pneumoniae, _
_Staphylococcus aureus _
and
_ Streptococcus pneumonia_
.
4.2
DOSE AND METHOD OF ADMINISTRATION
The dose of AZITH for the treatment of adult patients with community
acquired pneumonia is:
Azithromycin 500 mg as a single daily intravenous dose for at least
two days. Intravenous therapy
should be followed by oral therapy of 500 mg azithromycin administered
as a single daily dose to
complete a 7 to 10 day course of therapy. The timing of the conversion
to oral azithromycin therapy
should be done at the discretion of the doctor and in accordance with
clinical response.
After
reconstitution
and
dilution,
the
recommended
route
of
administration
for
intravenous
azithromycin is by IV infusion only. Do not administer as an
intravenous bolus or intramuscular
injection.
USE IN THE ELDERLY
No dose adjustment is necessary in elderly patients requiring
azithromycin therapy.
USE IN PATIENTS WITH RENAL IMPAIRMENT
No dose adjustment is needed in patients with mild or moderate renal
impairment. After oral
administration of a single dose of azithromycin 1 g in subjects with
severe renal impairment (GFR < 10
mL/minute), mean AUC
0 to 120 hours
and mean Cmax were increased by approximately 30 and 60%,
respec