ALPHACLAV DUO FORTE VIATRIS 875/125 amoxicillin 875 mg and clavulanic acid 125 mg tablets blister pack

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

amoxicillin trihydrate, Quantity: 1006.25 mg; potassium clavulanate, Quantity: 148.875 mg

Dostupné s:

Alphapharm Pty Ltd

INN (Mezinárodní Name):

amoxicillin trihydrate,potassium clavulanate

Léková forma:

Tablet, film coated

Složení:

Excipient Ingredients: microcrystalline cellulose; propylene glycol; croscarmellose sodium; ethylcellulose; purified talc; isopropyl alcohol; magnesium stearate; hypromellose; dichloromethane; titanium dioxide; hyprolose; industrial methylated spirit

Podání:

Oral

Jednotky v balení:

10, 60, 2

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

Alphaclav Duo Forte Viatris 875/125 amoxicillin 875 mg and clavulanic acid 125 mg 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 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 should not require the addition of another antibiotic due to the amoxicillin content of these products.

Přehled produktů:

Visual Identification: A white elongated capsule shaped film coated tablet.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizace:

Licence status A

Datum autorizace:

2017-01-17

Informace pro uživatele

ALPHACLAV
® DUO VIATRIS 500/125 &
ALPHACLAV
® DUO FORTE VIATRIS 875/125
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ALPHACLAV TABLETS?
ALPHACLAV DUO VIATRIS or ALPHACLAV DUO FORTE VIATRIS tablets contain
the active ingredients amoxicillin and clavulanic
acid and are used for the short term treatment of a wide range of
infections caused by bacteria. For more information, see Section 1.
Why am I using ALPHACLAV DUO VIATRIS or ALPHACLAV DUO FORTE VIATRIS
tablets? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ALPHACLAV TABLETS?
Do not use if you have ever had an allergic reaction to amoxicillin
trihydrate, potassium clavulanate, penicillin or similar types of
antibiotics (such as cephalosporins), or any of the ingredients listed
at the end of the CMI. Talk to your doctor if you have any other
medical conditions, take any other medicines, or are pregnant or plan
to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use
ALPHACLAV DUO VIATRIS or ALPHACLAV DUO FORTE
VIATRIS tablets? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ALPHACLAV DUO VIATRIS or ALPHACLAV
DUO FORTE VIATRIS tablets and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ALPHACLAV TABLETS?
Follow the directions given to you by your doctor and pharmacist.
Their directions may differ from the information contained in
this leaflet. More instructions can be found in Section 4. How do I
use ALPHACLAV DUO VIATRIS or ALPHACLAV DUO FORTE
VIATRIS tablets? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ALPHACLAV TABLETS?
THINGS YOU
SHOULD DO
•
Take ALPHACLAV tablets exactly as your doctor has prescribed.

Charakteristika produktu

AUSTRALIAN PRODUCT INFORMATION
ALPHACLAV
® DUO VIATRIS 500/125 AND
ALPHACLAV
® DUO FORTE VIATRIS 875/125
(_amoxicillin / clavulanic acid) film coated tablets_
1
NAME OF THE MEDICINE
Amoxicillin trihydrate and potassium clavulanate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ALPHACLAV DUO VIATRIS 500/125 and ALPHACLAV DUO FORTE VIATRIS 875/125
tablets
(amoxicillin and clavulanic acid 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).
ALPHACLAV DUO VIATRIS 500/125 Tablets: each film coated tablet
contains 500mg amoxicillin as the
trihydrate and 125mg clavulanic acid as the potassium salt.
ALPHACLAV DUO FORTE VIATRIS 875/125 Tablets: each film coated tablet
contains 875mg amoxicillin
as the trihydrate and 125mg clavulanic acid as the potassium salt.
Excipients with known effect: c
ontains 25 mg of elemental potassium per tablet
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ALPHACLAV DUO FORTE VIATRIS 875/125 Tablets: A white elongated capsule
shaped film coated
tablet.
ALPHACLAV DUO VIATRIS 500/125 Tablets: A white, oval shaped, film
coated tablet with marking
“CA625” on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ALPHACLAV DUO VIATRIS 500/125 and ALPHACLAV DUO FORTE VIATRIS 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 (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 am