Страна: Новая Зеландия
Язык: английский
Источник: Medsafe (Medicines Safety Authority)
Amoxicillin trihydrate 575mg equivalent to amoxicillin 500 mg; ;
Miro Healthcare Limited
Amoxicillin trihydrate 575 mg (equivalent to amoxicillin 500 mg)
500 mg
Capsule
Active: Amoxicillin trihydrate 575mg equivalent to amoxicillin 500 mg Excipient: Brilliant blue FCF Carmoisine Croscarmellose sodium Gelatin Ink Magnesium stearate Methyl hydroxybenzoate Propyl hydroxybenzoate Purified water Quinoline yellow Sodium laurilsulfate Sunset yellow FCF Titanium dioxide
Bottle, plastic, HDPE, 500 capsules
Prescription
Prescription
DSM Deretil SA
Amoxicillin is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms: Upper Respiratory Infections: Otitis media, pharyngitis, sinusitis and tonsillitis. Lower Respiratory Infections: Bronchitis, bronchopneumonia and lobar pneumonia. Urinary Tract Infections: Cystitis, cysto-pyelitis, urethritis, and gonococcal urethritis. Prophylaxis: against ?-haemolytic (viridans group) and ?-haemolytic Streptococci before dental, oral or upper respiratory tract surgery or instrumentation. Prophylaxis: of bacterial endocarditis in patients with any of the following conditions: congenital cardiac malformations, rheumatic and other acquired valvular lesions, prosthetic heart valves, previous history of bacterial endocarditis, hypertrophic cardiomyopathy, surgically constructed systemic-pulmonary shunts, mitral valve prolapse with valvular regurgitation or mitral valve prolapse without valvular regurgitation but associated with thickening and/or redundancy of the valve leaflets. Amoxicillin is further indicated for the treatment of cutaneous infections. In emergency cases where the causative organism is not yet identified, therapy may be initiated with amoxicillin on the basis of clinical judgement, while awaiting the results of bacteriologic studies to determine its antimicrobial sensitivity.
Package - Contents - Shelf Life: Bottle, plastic, HDPE - 500 capsules - 24 months from date of manufacture stored at or below 30°C
2009-12-09
New Zealand Consumer Medicine Information MIRO-AMOXICILLIN Amoxicillin 250 mg and 500 mg capsules WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Miro-Amoxicillin. This leaflet answers some common questions about Miro-Amoxicillin. 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 using Miro-Amoxicillin against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. You may need to read it again. WHAT MIRO-AMOXICILLIN IS USED FOR Miro-Amoxicillin contains penicillin called amoxicillin (as trihydrate) as the active ingredient. Miro-Amoxicillin belongs to a group of medicines called penicillins. Miro-Amoxicillin is used to treat a range of infections caused by bacteria. These may be infections of the chest (pneumonia), tonsils (tonsillitis), sinuses (sinusitis), urinary and genital tract, skin and fleshy tissues. Miro-Amoxicillin works by killing the bacteria that cause these infections. Miro- Amoxicillin can also be used to prevent infection. Your doctor may have prescribed Miro-Amoxicillin for another reason. Ask your doctor if you have any questions about why Miro-Amoxicillin has been prescribed for you. 1 Miro-Amoxicillin is available only with a doctor's prescription. There is no evidence that Miro-Amoxicillin is addictive. BEFORE YOU USE MIRO-AMOXICILLIN _ _ _ _ _WHEN YOU MUST NOT USE IT _ Do not use Miro-Amoxicillin if: • you are allergic to penicillin or similar types of antibiotics such as cephalosporins. If you have ever had an allergic reaction (such as a rash) when taking an antibiotic you should tell your doctor before you take Miro- Amoxicillin. • you have ever had an allergic reaction to amoxicillin or any of the ingredients listed toward the end of this leaflet. (See “Ingredients”) • the expiry date (E Прочитать полный документ
NEW ZEALAND DATA SHEET 1. PRODUCT NAME Miro-Amoxicillin Capsules 250 mg. Miro-Amoxicillin Capsules 500 mg. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Filled capsule contains Amoxicillin Trihydrate BP/EP equivalent to Amoxicillin 250 mg. Each Filled capsule contains Amoxicillin Trihydrate BP/EP equivalent to Amoxicillin 500 mg. For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Capsules: Amoxicillin 250 mg Capsules : Red / Buff coloured size ‘2’ capsules containing white to off white powder printed with ‘AMOXY 250’ in black ink. Amoxicillin 500 mg Capsules : Red / Buff Coloured size ‘0’ Capsules containing white to off white powder printed with ‘AMOXY 500 ‘ in black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amoxicillin is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms: Upper Respiratory Infections: Otitis media, pharyngitis, sinusitis and tonsillitis. Lower Respiratory Infections: Bronchitis, bronchopneumonia and lobar pneumonia. Urinary Tract Infections: Cystitis, cysto-pyelitis, urethritis, and gonococcal urethritis. Prophylaxis: against β-haemolytic (viridans group) and β-haemolytic Streptococci before dental, oral or upper respiratory tract surgery or instrumentation. NEW ZEALAND DATA SHEET Prophylaxis: of bacterial endocarditis in patients with any of the following conditions: congenital cardiac malformations, rheumatic and other acquired valvular lesions, prosthetic heart valves, previous history of bacterial endocarditis, hypertrophic cardiomyopathy, surgically constructed systemic- pulmonary shunts, mitral valve prolapse with valvular regurgitation or mitral valve prolapse without valvular regurgitation but associated with thickening and/or redundancy of the valve leaflets. Amoxicillin is further indicated for the treatment of cutaneous infections. In emergency cases where the causative organism is not yet identified, therapy may be initiated with amoxicillin on the basis of clinical judg Прочитать полный документ