AMOXYCLAV MLabs 875/125, amoxicillin (as trihydrate) 875 mg and clavulanic acid (as potassium) 125 mg tablets blister pack

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

potassium clavulanate, Quantity: 151.917 mg; amoxicillin trihydrate, Quantity: 1004.31 mg

Fáanlegur frá:

Micro Labs Pty Ltd

INN (Alþjóðlegt nafn):

amoxicillin trihydrate,potassium clavulanate

Lyfjaform:

Tablet, film coated

Samsetning:

Excipient Ingredients: dichloromethane; isopropyl alcohol; microcrystalline cellulose; sodium starch glycollate; magnesium stearate; colloidal anhydrous silica; titanium dioxide; hypromellose; propylene glycol; purified talc; ethylcellulose

Stjórnsýsluleið:

Oral

Einingar í pakka:

10 tablets

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

AMOXYCLAV MLabs 875/125 tablets are indicated for short-term treatment of bacterial infections at the following sites when caused by sensitive organisms (refer to Microbiology):,Urinary Tract Infections (complicated and uncomplicated),Lower Respiratory Tract Infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis,Upper Respiratory Tract Infections, such as sinusitis, otitis media and recurrent tonsillitis.,Skin and Skin Structure Infection.,Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to amoxicillin and clavulanic acid tablets. However, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed above, therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies. Once these results are known, therapy should be adjusted if appropriate. The treatment of mixed infections caused by amoxicillin susceptible organisms and beta-lactamase producing organisms susceptible to amoxicillin and clavulanic acid tablets preparations should not require the addition of another antibiotic due to the amoxicillin content of these products.

Vörulýsing:

Visual Identification: White colored capsule shaped film coated tablet debossed with 'I 07' on one side and plain on other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Leyfisstaða:

Licence status A

Leyfisdagur:

2017-08-07

Vara einkenni

AMOXYCLAV MLABS TABLETS
1
AUSTRALIAN
PRODUCT
INFORMATION-
AMOXYCLAV
MLABS
875/125
AND
AMOXYCLAV
MLABS
500/125
(AMOXICILLIN
AND
CLAVULANIC
ACID)
FILM-COATED
TABLETS
1.
NAME OF THE MEDICINE
Amoxicillin (as trihydrate) and clavulanic acid (as potassium).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
AMOXYCLAV MLabs tablets are combination products containing the
semisynthetic antibiotic,
amoxicillin (as the trihydrate) and the β-lactamase inhibitor,
potassium clavulanate (as the
potassium salt of clavulanic acid).
AMOXYCLAV MLabs 875/125 & AMOXYCLAV MLabs 500/125 tablets also contain
the
inactive ingredients: Microcrystalline cellulose, magnesium stearate,
sodium starch glycollate
Type A and colloidal anhydrous silica. The tablet coating contains
hypromellose, titanium
dioxide, propylene glycol, purified talc, ethylcellulose.
3.
PHARMACEUTICAL FORM
AMOXYCLAV
MLabs
500
/125
tablets
contain
amoxicillin
(as
trihydrate)
500
mg
and
clavulanic acid (as potassium clavulanate) 125 mg. White colored
capsule shaped film coated
tablet debossed with ‘Ɩ 06’ on one side and plain on other side.
AMOXYCLAV
MLabs
875
/125
tablets
contain
amoxicillin
(as
trihydrate)
875
mg
and
clavulanic acid (as potassium clavulanate) 125 mg. White colored
capsule shaped film coated
tablet debossed with ‘Ɩ 07’ on one side and plain on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
AMOXYCLAV MLabs tablets are indicated for short term treatment of
bacterial infections at
the following sites when caused by sensitive organisms (refer to
Microbiology):
Urinary Tract Infections (uncomplicated and complicated)
Lower Respiratory Tract Infections, including community acquired
pneumonia and acute
exacerbations of chronic bronchitis
Upper Respiratory Tract Infections, such as sinusitis, otitis media
and recurrent tonsillitis.
Skin and Skin Structure Infection
Appropriate culture and susceptibility studies should be performed to
identify the causative
organism(s) and determine its (their) susceptibility to amoxicillin
and clavulanic ac