AZITHROMYCIN VIATRIS Azithromycin (as monohydrate) 500mg Powder for Injection Vial

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

azithromycin, Quantity: 500 mg

Dostopno od:

Alphapharm Pty Ltd

INN (mednarodno ime):

Azithromycin

Farmacevtska oblika:

Injection, powder for

Sestava:

Excipient Ingredients: sodium hydroxide; citric acid monohydrate

Pot uporabe:

Intravenous Infusion

Enote v paketu:

1 vial

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

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.

Povzetek izdelek:

Visual Identification: A white to off-white lyophilized powder or cake.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status dovoljenje:

Licence status A

Datum dovoljenje:

2012-09-19

Navodilo za uporabo

AZITHROMYCIN
ALPHAPHARM
_azithromycin (as monohydrate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about AZITHROMYCIN
ALPHAPHARM.
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
AZITHROMYCIN ALPHAPHARM
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 AZITHROMYCIN
ALPHAPHARM IS
USED FOR
AZITHROMYCIN ALPHAPHARM
is used to treat Pneumonia, a lung
infection caused by certain bacteria
including Legionella pneumophila.
This medicine is an antibiotic, which
belongs to a group of medicines
called azalides.
The azalides are a sub-class of a
group of antibiotics called
macrolides.
This medicine works by killing or
stopping the growth of bacteria
causing your infection.
AZITHROMYCIN ALPHAPHARM
will not work against viral infections
such as colds or flu.
Ask your doctor if you have any
questions about why
AZITHROMYCIN ALPHAPHARM
has been prescribed for you. Your
doctor may have prescribed
AZITHROMYCIN ALPHAPHARM
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
BEFORE YOU ARE GIVEN
AZITHROMYCIN
ALPHAPHARM
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN
AZITHROMYCIN
ALPHAPHARM IF YOU HAVE AN
ALLERGY TO:
Azithromycin or any other ketolide
or macrolide antibiotic (e.g.
roxithromycin, erythromycin,
clarithromycin, telithromycin) or any
of the ingredients listed at the end of
this leaflet.
IF YOU ARE NOT SURE IF YOU ARE
ALLERGIC TO ANY OF THE ABOVE, ASK
YOUR DOCTOR.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty breathing;
swelling of the face, lips, tongue or
other parts

Lastnosti izdelka

AUSTRALIAN PRODUCT INFORMATION
AZITHROMYCIN ALPHAPHARM
_Azithromycin (as monohydrate) powder for injection _
1
NAME OF THE MEDICINE
Azithromycin (as monohydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of AZITHROMYCIN ALPHAPHARM 500 mg contains 500 mg of
azithromycin (as
monohydrate) as the active ingredient, providing 100 mg/mL solution
following reconstitution.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
_ _
3
PHARMACEUTICAL FORM
Azithromycin 500 mg 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 pneumoniae_
.
4.2
DOSE AND METHOD OF ADMINISTRATION
The dose of AZITHROMYCIN ALPHAPHARM 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 physician and in accordance
with clinical response.
After
re-constitution
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 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/min), mean AUC
0-120h
and mean C
max