国: ニュージーランド
言語: 英語
ソース: Medsafe (Medicines Safety Authority)
Clarithromycin 250mg; Clarithromycin 250mg
Apotex NZ Ltd
Clarithromycin 250 mg
250 mg
Film coated tablet
Active: Clarithromycin 250mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Hypromellose Iron oxide yellow Macrogol 8000 Magnesium stearate Microcrystalline cellulose Titanium dioxide Active: Clarithromycin 250mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Hypromellose Iron oxide yellow Macrogol 8000 Magnesium stearate Microcrystalline cellulose Titanium dioxide
Blister pack, PVC/PVdC/Al blister, 2 tablets
Prescription
Prescription
Ind-Swift Laboratories Limited
Clarithromycin is indicated for treatment of infections caused by susceptible organisms. Such infections include: 1. Respiratory tract infections including bronchitis, pneumonia, tonsillitis, sinusitis and pharyngitis. 2. Skin and soft tissue infections such as folliculitis, cellulitis and erysipelas. 3. Disseminated or localized mycobacterial infections due to Mycobacterium avium or Mycobacterium intracellulare. Localized infections due to Mycobacterium chelonae, Mycobacterium fortuitum or Mycobacterium kansasii. 4. Prevention of disseminated Mycobacterium avium complex infection in HIV-infected patients with CD4 lymphocyte counts less than or equal to 100/mm3.
Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Al blister - 2 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVdC/Al blister - 14 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVdC/Al blister - 28 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVdC/Al blister - 100 tablets - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE bottle with a PP cap - 14 tablets - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE bottle with a PP cap - 28 tablets - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE bottle with a PP cap - 100 tablets - 24 months from date of manufacture stored at or below 30°C
2009-07-20
APO-CLARITHROMYCIN TABLET 1 APO-CLARITHROMYCIN TABLET _Contains the active ingredient clarithromycin _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Apo-Clarithromycin. 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 Apo- Clarithromycin against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT THIS MEDICINE IS USED FOR Apo-Clarithromycin is used to treat certain bacterial infections, including the following: • Respiratory tract infections • Skin infections • Ear infections • Peptic ulcer Apo-Clarithromycin is also used to prevent a specific bacterial infection associated with HIV infection. Your doctor, however, may have prescribed clarithromycin for another purpose. Ask your doctor if you have any questions about why clarithromycin has been prescribed for you. Apo-Clarithromycin 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. Apo-Clarithromycin will not work against infections caused by virus, such as colds or flu. Apo-Clarithromycin is available only with a doctor’s prescription. _APO-CLARITHROMYCIN TO TREAT _ _PEPTIC ULCER _ Peptic ulcers are associated with an infection in the intestine and stomach caused by a bacteria called Helicobacter pylori (H. pylori). Nearly all patients with peptic ulcers are infected with this bacterium. The H. pylori infection can be treated with a combination of clarithromycin and other appropriate antibiotic and stomach acid control treatments. Your doctor will determine the best combination for you. If your symptoms return, consult your doctor. It is possible that clarithromycin may no long 完全なドキュメントを読む
NEW ZEALAND DATA SHEET APO-CLARITHROMYCIN Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 1 of 27 1. PRODUCT NAME APO-CLARITHROMYCIN (250mg and 500mg film coated tablets) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 250mg film coated tablet contains 250mg of clarithromycin. Each 500mg film coated tablet contains 500mg of clarithromycin. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Apo-Clarithromycin 250 mg tablets are pale yellow, oval, biconvex, film-coated tablets engraved “CLA250” on one side, “APO” on the other side. Apo-Clarithromycin 500 mg tablets are pale yellow, capsule-shaped, biconvex, film- coated tablets engraved “CLA500” on one side, “APO” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clarithromycin tablets are indicated for treatment of infections caused by susceptible organisms. Such infections include: • Respiratory tract infections including bronchitis, pneumonia, tonsillitis, sinusitis and pharyngitis (see section 4.4 and 5.1 regarding Sensitivity testing). • Skin and soft tissue infections such as folliculitis, cellulitis and erysipelas (see section 4.4 and 5.1 regarding Sensitivity testing). • Disseminated or localized mycobacterial infections due to _Mycobacterium _ _avium _ or _Mycobacterium _ _intracellulare_. Localized infections due to _Mycobacterium chelonae_, _Mycobacterium fortuitum_, or _Mycobacterium kansasii_. • Prevention of disseminated _ Mycobacterium avium _ complex infection in HIV- infected patients with CD4 lymphocyte counts less than or equal to 100/mm 3 . • Clarithromycin in the presence of acid suppression is indicated for the treatment of duodenal ulcer and in reducing the rate of ulcer recurrence (see section 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents. APO-CLARITHROMYCIN Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 2 of 27 4.2 DOSE AND METHOD OF 完全なドキュメントを読む