Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
azithromycin dihydrate, Quantity: 209.65 mg (Equivalent: azithromycin, Qty 200 mg)
Pfizer Australia Pty Ltd
Suspension, powder for
Excipient Ingredients: sucrose; tribasic sodium phosphate; hyprolose; xanthan gum; Flavour
Oral
1500mg/37.5mL when reconstituted, 900mg/22.5mL when reconstituted, 1200mg/30mL when reconstituted, 600mg/15mL when reconstituted
(S4) Prescription Only Medicine
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.
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
Licence status A
1997-09-05
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 Olvassa el a teljes dokumentumot
Version:pfpzithb10122 Supersedes: pfpzithb10721 Page 1 of 21 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. Version:pfpzithb10122 Supersedes: pfpzithb10721 Page 2 of 21 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 Olvassa el a teljes dokumentumot