Kraj: Nowa Zelandia
Język: angielski
Źródło: Medsafe (Medicines Safety Authority)
Azithromycin dihydrate 261.02mg equivalent to 250 mg azithromycin
Apotex NZ Ltd
Azithromycin dihydrate 261.02 mg (equivalent to 250 mg azithromycin)
250 mg
Film coated tablet
Active: Azithromycin dihydrate 261.02mg equivalent to 250 mg azithromycin Excipient: Calcium hydrogen phosphate dihydrate Croscarmellose sodium Hyprolose Magnesium stearate Opadry white 31K58875 Purified water
Blister pack, white opaque PVC/aluminium 2 tablets, 2 tablets
Prescription
Prescription
Alembic Pharmaceuticals Limited (API Division)
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, Community acquired pneumonia). 2. Upper respiratory tract infections (Acute sinusitis, Acute streptococcal pharyngitis, Acute otitis media). 3. Uncomplicated skin and skin structure infections (Uncomplicated infections, Sexually transmitted diseases, Pelvic Inflammatory Disease). 4. Chlamydia trachomatis conjunctivitis and trachoma. 5. Prevention of infection due to Mycobacterium avium-intracellulare Complex (MAC) disease. Azithromycin is indicated for use in children for the treatment of the following infections: 1. Lower respiratory tract infections (Acute bacterial bronchitis, Community acquired pneumonia). 2. Upper respiratory tract infections (Acute sinusitis, Acute streptococcal pharyngitis, Acute otitis media). 3. Uncomplicated skin and skin structure infections (Uncomplicated infections, Sexually transmitted diseases, Pelvic Inflammatory Disease). 4. Prevention of infection due to Mycobacterium avium-intracellulare Complex (MAC) disease. 5. Acute streptococcal pharyngitis/tonsillitis. 6. Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. The 20 mg/kg azithromycin dose appears to be 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. 7. Chlamydia trachomatis conjunctivitis and trachoma in children 12 months or older.
Package - Contents - Shelf Life: Blister pack, white opaque PVC/aluminium 2 tablets - 2 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, white, round HDPE with blue PP 'lift'n'peel' cap closure 30 tablets - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, white, round HDPE with blue PP 'lift'n'peel' cap closure 500 tablets - 500 tablets - 36 months from date of manufacture stored at or below 25°C
2008-08-01
APO-AZITHROMYCIN TABLETS 1 APO-AZITHROMYCIN TABLETS _Contains the active ingredient azithromycin (as azithromycin dihydrate) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Azithromycin. 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 Azithromycin 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 THIS MEDICINE IS USED FOR Azithromycin is used to treat infections in different parts of the body caused by bacteria. It is commonly used to treat Chlamydia. Azithromycin is also used to prevent infections by a bacterium called Mycobacterium Aviumintracellulare Complex (MAC) in some people. Azithromycin 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. Azithromycin works by killing or stopping the growth of bacteria causing your infection. Azithromycin will not work against viral infections such as colds or flu. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY AZITHROMYCIN 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. _USE IN CHILDREN _ There is not enough information to recommend the use of azithromycin tablets in children. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE AZITHROMYCIN 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 Przeczytaj cały dokument
NEW ZEALAND DATA SHEET APO-AZITHROMYCIN Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 1 of 21 1. APO-AZITHROMYCIN (250MG AND 500MG TABLETS) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Azithromycin 250mg and 500mg (as dihydrate) Excipient(s) of known effect APO-AZITHROMYCIN does not contain gluten or lactose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Apo-Azithromycin 250mg tablets are white, oval, film coated tablets embossed “AZ250” one side and “APO” on the other. Each tablet contains azithromycin dihydrate equivalent to azithromycin 250mg. Apo-Azithromycin 500mg tablets are white, oval, film coated tablets embossed “AZ500” one side and “APO” on the other. Each tablet contains azithromycin dihydrate equivalent to azithromycin 500mg.” 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: 1. LOWER RESPIRATORY TRACT INFECTIONS: ACUTE BACTERIAL BRONCHITIS due to _Streptococcus _ _pneumoniae, _ _Haemophilus _ _influenza _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_. APO-AZITHROMYCIN Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 2 of 21 ACUTE STREPTOCOCCAL PHARYNGITIS. Note: Penicillin is the usual drug of choice in the treatment of _ Streptococcus pyogenes _ pharyngitis, Przeczytaj cały dokument