ZITHROMAX azithromycin (as dihydrate) 200mg/5mL (when reconstituted)

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

azithromycin dihydrate, Quantity: 209.65 mg (Equivalent: azithromycin, Qty 200 mg)

זמין מ:

Pfizer Australia Pty Ltd

טופס פרצבטיות:

Suspension, powder for

הרכב:

Excipient Ingredients: sucrose; tribasic sodium phosphate; hyprolose; xanthan gum; Flavour

מסלול נתינה (של תרופות):

Oral

יחידות באריזה:

1500mg/37.5mL when reconstituted, 900mg/22.5mL when reconstituted, 1200mg/30mL when reconstituted, 600mg/15mL when reconstituted

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

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 Haemphilus 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 drugs 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 conjunctivits and trachoma. Azithromycin is also indicated for the prevention of infection due to Mycobacterium avium-intracellulare 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-intracellulare complex should be excluded by a negative blood culture prior to commencement of therapy. Azithromycin is indicated for use in children for the treatment of the following infections: 1. Acute streptococcal pharyngitis/tonsillitis. Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. The 20mg/kg azithromycin dose appears to be almost as effective as penicillin 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. 2. Chlamydia trachomatis conjunctivitis and trachoma in children 12 months or older.

leaflet_short:

Visual Identification: White to off-white powder; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

מצב אישור:

Licence status A

תאריך אישור:

1997-09-05

עלון מידע

ZITHROMAX
®
TABLETS AND ORAL SUSPENSION
_Azithromycin (a-zithro-my-sin)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Zithromax. 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 Zithromax
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 YOUR
MEDICINE.
You may need to read it again.
WHAT ZITHROMAX IS
USED FOR
Zithromax is used to treat infections
in different parts of the body caused
by bacteria.
It is commonly used to treat
Chlamydia. Zithromax is also used to
prevent infections by a bacterium
called Mycobacterium Avium-
intracellulare Complex (MAC) in
some people.
Zithromax 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.
Zithromax works by killing or
stopping the growth of bacteria
causing your infection.
Zithromax will not work against viral
infections such as colds or flu.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ZITHROMAX
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Zithromax is only available with a
doctor's prescription.
This medicine is not addictive.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
BEFORE YOU TAKE
ZITHROMAX
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ZITHROMAX IF YOU ARE
ALLERGIC TO:
•
azithromycin
•
any other macrolide or ketolide
antibiotics (e.g., clarithromycin,
erythromycin, roxithromycin,
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.
DO NOT TAKE TH

מאפייני מוצר

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AUSTRALIAN
PRODUCT
INFORMATION
–
ZITHROMAX
® (AZITHROMYCIN DIHYDRATE)
1.
NAME OF THE MEDICINE
Azithromycin dihydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zithromax capsules contain azithromycin dihydrate equivalent to 250 mg
of azithromycin.
Zithromax tablets contain azithromycin dihydrate equivalent to 250 mg,
500 mg or 600 mg of
azithromycin.
Zithromax powder for oral suspension (POS) contains zithromycin
dihydrate equivalent to
200 mg of azithromycin per 5 mL of suspension, when reconstituted
.
EXCIPIENT(S) WITH KNOWN EFFECT
Excipient(s) with known effect in capsules: sugars as lactose
Excipient(s) with known effect in tablets: lactose
Excipient(s) with known effect in powder for oral suspension: sugars
(each 5 mL of
reconstituted product contains 3.87 g of sucrose) and milk products
For the full list of excipients, see Section 6.1, List of excipients.
3. PHARMACEUTICAL FORM
Zithromax capsules are No.0 capsules with a white body and a white cap
printed in black
with “Pfizer” and “ZTM-250”.
Zithroax 250 mg tablets are white to off white, unscored, modified
capsule shaped film
coated tablets, engraved with with “Pfizer” on one side and “ZTM
250” on the other side.
Zithromax 500 mg tablets are white to off white, unscored, modified
capsule shaped film
coated tablets, engraved with “Pfizer” on one side and “ZTM
500” on the other side
.
Zithromax 600 mg tablets are white to off white, scored, modified oval
film coated tablets
engraved with 'ZTM 600' on one side and 'PFIZER' on the other side.
Zithroax powder for oral suspension (POS) is a white to off-white
powder.
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4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC 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
_Morax