Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
clarithromycin, Quantity: 250 mg
Sandoz Pty Ltd
Clarithromycin
Tablet, film coated
Excipient Ingredients: titanium dioxide; powdered cellulose; magnesium stearate; hypromellose; macrogol 4000; croscarmellose sodium; microcrystalline cellulose; colloidal anhydrous silica; lactose monohydrate
Oral
100, 14
(S4) Prescription Only Medicine
CLARITHROMYCIN SANDOZ clarithromycin is indicated for use in adults and children older than 12 years for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro-organisms in the conditions listed below: Acute streptococcal pharyngitis; Community acquired pneumonia due to Chlamydia pneumoniae, Mycoplasma pneumoniae, Legionella pneumophilia and Streptococcus pneumoniae;Uncomplicated skin and skin structure infections due to Staphylococcus aureus or Streptococcus pyogenes;Disseminated or localised mycobacterial infections due to Mycobacterium avium or Mycobacterium intracellulare and skin and skin structure infections due to Mycobacterium chelonae. Clarithromycin should be used in combination with other anti mycobacterial agents.Prevention of disseminated Mycobacterium avium complex infection in HIV infected adults with CD4 lymphocyte counts <75 cells/mm 3 (See Precautions). Disseminated infection due to Mycobacterium avium complex should be excluded by a negative blood culture prior to commencement of prophylaxis.Acute bacterial exacerbation of chronic bronchitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae;Combination therapy for the treatment of peptic ulcer disease associated with Helicobacter pylori infection. CLARITHROMYCIN SANDOZ clarithromycin is indicated for use in children for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro organisms in the conditions listed below:Acute streptococcal pharyngitis and tonsillitis caused by Streptococcus pyogenes; Community acquired pneumonia including infections due to Chlamydia pneumoniae, Mycoplasma pneumoniae and Legionella pneumophila; Skin and skin structure infections (eg impetigo); Disseminated or localised infections due to Mycobacterium avium or Mycobacterium intracellulare in immunocompromised children, including those with HIV Infection or AIDS. Acute otitis media.Note:1. Penicillins are the drug of first choice in the treatment of acute otitis media. 2. Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections including prophylaxis of rheumatic fever. Clarithromycin appears to be as effective as phenoxymethylpenicillin in the eradication of streptococci from the nasopharynx, however substantial data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present. 3. There is insufficient evidence of efficacy to support the use of Clarithromycin in acute bronchitis in young children. 4. The data presented on infections of skin and skin structure were confined largely to mild to moderate infections such as impetigo.
Visual Identification: White, oblong, convex tablets, scored on both faces; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2005-08-29
CLARITHROMYCIN SANDOZ ® 1 CLARITHROMYCIN SANDOZ ® _Clarithromycin (kla-ree-thro-MY-sin) tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Clarithromycin 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 risk of you taking Clarithromycin Sandoz against the benefits it is expected to 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 CLARITHROMYCIN SANDOZ IS USED FOR Clarithromycin Sandoz is used to treat certain bacterial infections, including the following: • respiratory tract infections (throat, airways and lungs) • ear infections • skin infections • peptic ulcer Clarithromycin Sandoz is also used to prevent a specific bacterial infection associated with HIV infection. Clarithromycin Sandoz is an antibiotic that belongs to the group of medicines called macrolides. These medicines work by killing or stopping the growth of bacteria which cause infections. It contains the active ingredient clarithromycin. Your doctor, however, may have prescribed Clarithromycin Sandoz for another purpose. Ask your doctor if you have any questions about why Clarithromycin Sandoz has been prescribed for you. Clarithromycin Sandoz will not work against infections caused by viruses, such as colds or flu. CLARITHROMYCIN SANDOZ TO TREAT PEPTIC ULCER Peptic ulcers are associated with an infection in the intestine and stomach by a bacteria called Helicobacter pylori (H. pylori). Nearly all patients with peptic ulcers are infected with this bacteria. The H. pylori infection can be treated with a combination of Clarithromycin Sandoz (clarithromycin), another appropriate antibiotic and stomach acid control treatments. However, the best combination of tablets to treat H. pylori infection is yet to be determined. Lesen Sie das vollständige Dokument
130819-Clarithromycin-sandoz-pi Page 1 of 28 AUSTRALIAN PRODUCT INFORMATION CLARITHROMYCIN SANDOZ ® (CLARITHROMYCIN) 1 NAME OF THE MEDICINE Clarithromycin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Clarithromycin Sandoz 250 mg contains 250 mg clarithromycin. Each Clarithromycin Sandoz 500 mg contains 500 mg clarithromycin. _Not all strengths may be marketed in Australia. _ _Excipient with known effect: _ lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Clarithromycin Sandoz 250 mg film-coated tablets are white, oblong, convex tablets, scored on both faces. Clarithromycin Sandoz 500 mg film-coated tablets are white, oblong, convex tablets scored on both faces. _ _ 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Clarithromycin Sandoz (clarithromycin) is indicated for use in adults and children older than 12 years for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro-organisms in the conditions listed below: 1. Acute streptococcal pharyngitis 2. Community acquired pneumonia due to _Chlamydia _ _pneumoniae, _ _Mycoplasma _ _pneumoniae, Legionella pneumophila _ and _Streptococcus pneumoniae _ (See Section 4.4 Special warnings and precautions for use regarding sensitivity testing) 3. Uncomplicated skin and skin structure infections due to _Staphylococcus aureus _ or _Streptococcus pyogenes _ (See Section 4.4 Special warnings and precautions for use regarding sensitivity testing) 4. Disseminated or localised mycobacterial infections due to _ Mycobacterium avium _ or _Mycobacterium intracellulare_ and skin and skin structure infections due to _Mycobacterium _ _chelonae_ . Clarithromycin should be used in combination with other antimycobacterial agents 5. Prevention of disseminated _Mycobacterium avium_ complex infection in HIV-infected adults with CD4 lymphocyte counts < 75 cells/mm 3 (see Section 4.4 Special warnings and precautions for use). Disseminated infection due to _Mycobacterium aviu Lesen Sie das vollständige Dokument