AZITHROMYCIN SANDOZ azithromycin (as dihydrate) 500mg tablet blister pack

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

azithromycin dihydrate, Quantity: 524.1 mg (Equivalent: azithromycin, Qty 500 mg)

Disponibbli minn:

Sandoz Pty Ltd

INN (Isem Internazzjonali):

azithromycin dihydrate

Għamla farmaċewtika:

Tablet, film coated

Kompożizzjoni:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; maize starch; sodium lauryl sulfate; sodium starch glycollate type A; colloidal anhydrous silica; lactose monohydrate; hypromellose; titanium dioxide; macrogol 4000

Rotta amministrattiva:

Oral

Unitajiet fil-pakkett:

3 tablets, 2 tablets

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

Azithromycin is indicated for use in adults for the treatment of the following infections of mild to moderate severity: 1. Lower respiratory tract infections: Acute bacterial bronchitis due to Streptococcus pneumoniae, Haemophilus influenzae or Moraxella catarrhalis.Community acquired pneumonia due to Streptococcus pneumoniae or Haemophilus influenzae in patients suitable for outpatient oral treatment. 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. 2. Upper respiratory tract infections: Acute sinusitis due to Streptococcus pneumoniae or Haemophilus influenzae. Acute streptococcal pharyngitis. Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. Azithromycin appears to be almost as effective in the treatment of streptococcal pharyngitis. However, substantial data establishing the efficacy of azithromycin in the subsequent prevention of rheumatic fever are not available at present. 3. Uncomplicated skin and skin structure infections: Uncomplicated infections due to Staphylococcus aureus, Streptococcus pyogenes or Streptococcus agalactiae. Abscesses usually require surgical drainage. 4. Sexually transmitted diseases: Uncomplicated urethritis and cervicitis due to Chlamydia trachomatis. . Note: At the recommended dose azithromycin cannot be relied upon to treat gonorrhoea or syphilis. As with other medicines for the treatment of non-gonococcal infections, it may mask or delay the symptoms of incubating gonorrhoea or syphilis. Appropriate tests should be performed for the detection of gonorrhoea or syphilis and treatment should be instituted as required. Azithromycin is also indicated for the treatment of Chlamydia trachomatis conjunctivitis and trachoma. Azithromycin is also indicated for the prevention of infection due to Mycobacterium avium-intracellular Complex (MAC) disease, when used as the sole agent or in combination with rifabutin at its approved dose, in adults and children aged more than 12 years with HIV infection and CD4 cell count less than or equal to 75 cells/microliter (see Precautions). Disseminated infection due to Mycobacterium avium-intracellular complex should be excluded by a negative blood culture prior to commencement of therapy.

Sommarju tal-prodott:

Visual Identification: white to off-white, oval film-coated tablets, plain on one side with a breaking notch and 'A500' embossed on the other side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2009-04-29

Fuljett ta 'informazzjoni

AZITHROMYCIN SANDOZ
®
1
AZITHROMYCIN SANDOZ
®
_azithromycin dihydrate _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Azithromycin
Sandoz.
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 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 want to read it again.
WHAT
AZITHROMYCIN
SANDOZ IS USED
FOR
This medicine is used to treat
infections in different parts of the
body caused by bacteria. It is
commonly used to treat Chlamydia.
It contains the active ingredient
azithromycin.
Azithromycin belongs to a group of
medicines called azalides. The
azalides are a sub-class of a group of
antibiotics called macrolides.
It works by killing or stopping the
growth of bacteria causing your
infection. Azithromycin Sandoz will
not work against viral infections such
as colds or flu.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
BEFORE YOU TAKE
AZITHROMYCIN
SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
azithromycin, the active
ingredient, or to any of the other
ingredients listed at the end of
this leaflet under Product
Description
•
any other macrolide or ketolide
antibiotics (e.g. clarithromycin,
erythromycin, roxithromycin,
telithromycin).
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 parts of the body
•
rash, itching or hives on the skin.
DO NOT TAKE THIS MEDICINE AFTER THE
E

Karatteristiċi tal-prodott

220316-azithromycin-sandoz-pi
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION
AZITHROMYCIN SANDOZ
® (AZITHROMYCIN DIHYDRATE)
1
NAME OF THE MEDICINE
Azithromycin dihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Azithromycin Sandoz 500 mg film coated tablet contains 500 mg
azithromycin.
_List of excipients with known effect:_
lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Azithromycin Sandoz 500 mg tablets – white to off-white, oval
film-coated tablets, plain on
one side, with a breaking notch and ‘A500’ embossed on the other
side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Azithromycin is indicated for use in adults for the treatment of the
following infections of mild
to moderate severity:
•
_LOWER RESPIRATORY TRACT INFECTIONS: _
Acute bacterial bronchitis due to
_Streptococcus pneumoniae, Haemophilus influenzae_
or
_Moraxella catarrhalis._
Community acquired pneumonia due to
_Streptococcus pneumoniae_
or
_Haemophilus _
_influenzae_
in patients suitable for outpatient oral treatment.
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_
.
•
_UPPER RESPIRATORY TRACT INFECTIONS: _
Acute sinusitis due to
_Streptococcus pneumoniae_
or
_Haemophilus influenzae_
.
Acute streptococcal pharyngitis. Note: Penicillin is the usual drug of
choice in the treatment
of Streptococcus pyogenes pharyngitis, including the prophylaxis of
rheumatic fever.
Azithromycin appears to be almost as effective in the treatment of
streptococcal pharyngitis.
However, substantial data establishing the efficacy of azithromycin in
the subsequent
prevention of rheumatic fever are not available at present.
_ _
•
_UNCOMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS: _
Uncomplicated in