Miro-Amoxicillin

Ülke: Yeni Zelanda

Dil: İngilizce

Kaynak: Medsafe (Medicines Safety Authority)

Aktif bileşen:

Amoxicillin trihydrate 575mg equivalent to amoxicillin 500 mg;  ;  

Mevcut itibaren:

Miro Healthcare Limited

INN (International Adı):

Amoxicillin trihydrate 575 mg (equivalent to amoxicillin 500 mg)

Doz:

500 mg

Farmasötik formu:

Capsule

Kompozisyon:

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  

Paketteki üniteler:

Bottle, plastic, HDPE, 500 capsules

Sınıf:

Prescription

Reçete türü:

Prescription

Tarafından üretildi:

DSM Deretil SA

Terapötik endikasyonlar:

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.

Ürün özeti:

Package - Contents - Shelf Life: Bottle, plastic, HDPE - 500 capsules - 24 months from date of manufacture stored at or below 30°C

Yetkilendirme tarihi:

2009-12-09

Bilgilendirme broşürü

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

Ürün özellikleri

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