Land: Nieuw-Zeeland
Taal: Engels
Bron: Medsafe (Medicines Safety Authority)
Azithromycin dihydrate 524mg equivalent to 500 mg Azithromycin; ;
Pfizer New Zealand Limited
Azithromycin dihydrate 524 mg (Equiv to 500 mg Azithromycin)
500 mg
Film coated tablet
Active: Azithromycin dihydrate 524mg equivalent to 500 mg Azithromycin Excipient: Calcium hydrogen phosphate Croscarmellose sodium Magnesium stearate/sodium lauryl sulfate 90/10 blend Opadry white Y-30-18037 Pregelatinised maize starch Purified water
Blister pack, PVC/Al, 2, 2 tablets
Prescription
Prescription
Pfizer Asia Pacific Pte Ltd
Package - Contents - Shelf Life: Blister pack, PVC/Al, 2 - 2 tablets - 60 months from date of manufacture stored at or below 30°C - Blister pack, PVC/Al, 3 - 3 tablets - 60 months from date of manufacture stored at or below 30°C - Blister pack, PVC/Al, 15 - 15 tablets - 60 months from date of manufacture stored at or below 30°C - Bottle, plastic, - 30 tablets - 60 months from date of manufacture stored at or below 30°C
1997-01-08
ZITHROMAX ® 1 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. Lees het volledige document
Version: pfdzithb10922 Supersedes: pfdzithb11121 Page 1 of 23 NEW ZEALAND DATA SHEET 1. PRODUCT NAME ZITHROMAX ® 250 mg, 500 mg and 600 mg tablets, film-coated ZITHROMAX ® 40 mg/mL powder for oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TABLETS Tablets contain azithromycin dihydrate equivalent to 250 mg, 500 mg or 600 mg of azithromycin. POWDER FOR ORAL SUSPENSION Powder for oral suspension (POS) contains azithromycin dihydrate equivalent to 40 mg/mL azithromycin solution following reconstitution. EXCIPIENTS WITH KNOWN EFFECTS 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 approximately 3.87 g of sucrose) and milk products For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM TABLETS ZITHROMAX 250 mg tablets are white to off-white, unscored, modified capsule shaped film coated tablets, engraved 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. POWDER FOR ORAL SUSPENSION ZITHROMAX powder for oral suspension (POS) is a white to off-white powder. Version: pfdzithb10922 Supersedes: pfdzithb11121 Page 2 of 23 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS ADULTS 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 Lees het volledige document