CURAM 125/31.25 amoxicillin (as trihydrate) 125mg/5mL clavulanic acid (as potassium clavulanate) 31.25mg/5mL powder for suspension bottle

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

potassium clavulanate, Quantity: 7.45 mg/mL (Equivalent: clavulanic acid, Qty 6.25 mg/mL); amoxicillin trihydrate, Quantity: 28.7 mg/mL (Equivalent: amoxicillin, Qty 25 mg/mL)

Inapatikana kutoka:

Sandoz Pty Ltd

INN (Jina la Kimataifa):

amoxicillin trihydrate,potassium clavulanate

Dawa fomu:

Suspension, powder for

Tungo:

Excipient Ingredients: sodium citrate; purified talc; Guar Gum; silicon dioxide; aspartame; citric acid; Flavour

Njia ya uendeshaji:

Oral

Vitengo katika mfuko:

100 mL bottles

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

Treatment of the following infections when caused by CURAM 125/31.25 sensitive, beta-lactamase producing organisms: Skin and skin structure infections, including cases caused by beta-lactamase producing Staph. aureus, E. coli and Klebsiella sp. (only some strains may be sensitive). Urinary tract infections, including cases caused by beta-lactamase producing E. coli, P. mirabilis and Klebsiella sp. Upper respiratory tract infections, such as sinusitis, including cases caused by beta-lactamase producing H. influenzae and M. catarrhalis, and otitis media, especially cases caused by beta-lactamase producing H. influenzae, M. catarrhalis and Staph. aureus. Lower respiratory tract infections, especially cases caused by beta-lactamase producing H. influenzae and M. catarrhalis. Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to CURAM 125/31.25. However, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in Microbiology, 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 amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to CURAM 125/31.25 should not require the addition of another antibiotic due to the amoxycillin content of CURAM 125/31.25.

Bidhaa muhtasari:

Visual Identification: Off-white powder; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Idhini hali ya:

Registered

Idhini ya tarehe:

2009-03-06

Taarifa za kipeperushi

CURAM
®
125/31.25
1
CURAM
® 125/31.25
_amoxicillin (as trihydrate) and clavulanic acid (as potassium
clavulanate) 125 mg+31.25 mg/5 mL powder _
_for oral suspension _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Curam 125/31.25.
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 your child taking this
medicine against the benefits they
expect it will have.
IF YOU HAVE ANY CONCERNS ABOUT
YOUR CHILD TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CURAM 125/31.25
IS USED FOR
This medicine is used to treat a wide
range of infections caused by
bacteria. These infections may affect:
•
the chest (bronchitis or
pneumonia)
•
the bladder (cystitis)
•
the sinuses (sinusitis)
•
the ears (otitis media)
•
or the skin.
It works by killing the bacteria that
cause these infections.
This medicine contains the active
ingredients amoxicillin (as
trihydrate) and clavulanic acid (as
potassium clavulanate). Amoxicillin
belongs to the penicillin group of
antibiotics. Clavulanic acid is used to
increase the effectiveness of
amoxicillin against certain types of
bacteria.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOUR CHILD.
Your doctor may have prescribed it
for another reason.
There is no evidence that this
medicine is addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU GIVE
CURAM 125/31.25
_WHEN YOU MUST NOT GIVE IT _
DO NOT GIVE THIS MEDICINE IF YOUR
CHILD HAS AN ALLERGY TO:
•
amoxicillin trihydrate or
potassium clavulanate, the active
ingredients, or to any of the other
ingredients listed at the end of
this leaflet under Product
description
•
any other similar medicines (such
as penicillins, cephalosporins,
carbapenems, monobactams or
any other types of antibi

Tabia za bidhaa

200511-curam-pi
Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION
CURAM 125/31.25 (AMOXICILLIN TRIHYDRATE/POTASSIUM
CLAVULANATE) POWDER FOR SUSPENSION
1.
NAME OF THE MEDICINE
Amoxicillin trihydrate/Potassium clavulanate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL of reconstituted suspension contains 125 mg amoxicillin and
31.25 mg potassium
clavulanate.
When reconstituted as directed, Curam 125/31.25 contains aspartame 8.5
mg/5 mL.
Each 5 mL of suspension contains 0.16 mmol of potassium.
For the full list of excipients, see Section 6.1 List of excipients
3.
PHARMACEUTICAL FORM
Curam 125/31.25 amoxicillin 125 mg/5 mL (as trihydrate) & clavulanic
acid 31.25 mg/5 mL
(as potassium clavulanate) powder for suspension: off-white powder and
off-white suspension.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Curam 125/31.25 (amoxicillin and clavulanic acid) is indicated for the
treatment of the
following infections when caused by Curam 125/31.25 sensitive,
beta-lactamase producing
organisms:

skin and skin structure infections, including cases caused by
beta-lactamase producing
_Staph. aureus, E. coli_
and
_Klebsiella sp._
(only some strains may be sensitive).

urinary tract infections, including cases caused by beta-lactamase
producing
_E. coli, P. _
_mirabilis_
and
_Klebsiella sp._

upper respiratory tract infections, such as sinusitis, including cases
caused by beta-
lactamase producing
_H. influenzae_
and M
_. catarrhalis_
, and otitis media, especially
cases caused by beta-lactamase producing
_H. influenzae_
,
_M. catarrhalis_
and
_Staph. _
_aureus_
.

lower respiratory tract infections, especially cases caused by
beta-lactamase producing
_H. influenzae_
and
_M. catarrhalis_
.
Appropriate culture and susceptibility studies should be performed to
identify the causative
organism(s) and determine its (their) susceptibility to Curam
125/31.25 (amoxicillin and
clavulanic acid). However, when there is reason to believe an
infection may involve any of the
beta-lactamase producing organisms listed in