Curam

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Amoxicillin trihydrate 287mg equivalent to Amoxycillin 250 mg;  ; Potassium clavulanate 149mg equivalent to Clavulanic acid 125 mg

Tilgjengelig fra:

Sandoz New Zealand Limited

INN (International Name):

Amoxicillin trihydrate 287 mg (=Amoxycillin 250 mg)

Dosering :

250mg/125mg

Legemiddelform:

Film coated tablet

Sammensetning:

Active: Amoxicillin trihydrate 287mg equivalent to Amoxycillin 250 mg   Potassium clavulanate 149mg equivalent to Clavulanic acid 125 mg Excipient: Croscarmellose sodium Ethylcellulose Hypromellose Magnesium stearate Microcrystalline cellulose Povidone Purified talc   Purified water Titanium dioxide Triethyl citrate

Enheter i pakken:

Aluminium foil, PE internal coat, 15 tablets

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

Sandoz Industrial Products SA

Indikasjoner:

Short term treatment of common bacterial infections such as: Upper respiratory tract infections (including ENT): e.g. tonsillitis, sinusitis, otitis media Lower respiratory tract infections: e.g. acute exacerbations of chronic bronchitis, lobar and broncho-pneumonia Genito-urinary tract infections: e.g. cystitis, urethritis, pyelonephritis, female genital infections Skin and soft tissue infections Bone and joint infections: e.g. osteomyelitis Other infections: e.g. septic abortion, puerperal sepsis, intra-abdominal sepsis, septicaemia, peritonitis and post-surgical infections. Prophylaxis against infection which may be associated with major surgical procedures such as gastro-intestinal, pelvic, head and neck, cardiac, renal, joint replacement and biliary tract surgery. Infections caused by amoxycillin susceptible organisms are amenable to amoxycillin/clavulanic acid treatment due to its amoxycillin content. Mixed infections caused by amoxycillin susceptible organisms in conjunction with amoxycillin/clavulanic acid susceptible beta-lactamase-producing organisms may therefore be treated by amoxycillin/clavulanic acid.

Produkt oppsummering:

Package - Contents - Shelf Life: Aluminium foil, PE internal coat - 15 tablets - 24 months from date of manufacture stored at or below 25°C - Aluminium foil, PE internal coat - 21 tablets - 24 months from date of manufacture stored at or below 25°C - Aluminium foil, PE internal coat - 100 tablets - 24 months from date of manufacture stored at or below 25°C

Autorisasjon dato:

1998-11-10

Informasjon til brukeren

CURAM
®
DUO 500/125
1
CURAM
® DUO 500/125
_tablets _
_amoxicillin trihydrate/potassium clavulanate equivalent to 500 mg
amoxicillin/125 mg clavulanic acid _
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Curam Duo 500/125.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
Please read this leaflet before you
start taking Curam Duo 500/125. If
you are helping someone else take
Curam Duo 500/125, please read this
leaflet before you give the first dose.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CURAM DUO
500/125 IS USED FOR
This medicine is used for the short
term treatment of 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)
•
the bones and joints
(osteomyelitis)
•
or the skin.
Curam Duo 500/125 will not work
against infections caused by viruses
such as colds or the flu.
Curam Duo 500/125 is an antibiotic
that belongs to a group of medicines
called penicillins. It works by killing
the bacteria that cause these
infections.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
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 TAKE
CURAM DUO 500/125
_WHEN YOU MUST NOT TAKE IT _
DO NOT GIVE THIS MEDICINE IF YOU
HAVE 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

Preparatomtale

231013-Curam-ds-v1.0
Page 1 of 15
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Curam Powder for oral suspension
Curam Film coated tablet
Curam Duo 500/125 Film coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CURAM TABLET
_250 + 125 MG_
Each tablet contains Amoxicillin Trihydrate Ph. Eur. equivalent to
amoxicillin 250 mg and
Potassium Clavulanate Ph. Eur. equivalent to clavulanic acid 125 mg.
CURAM DUO 500/125 TABLET
_500 + 125 MG _
Each tablet contains Amoxicillin Trihydrate Ph. Eur. equivalent to
amoxicillin 500 mg and
Potassium Clavulanate Ph. Eur. equivalent to clavulanic acid 125 mg.
CURAM POWDER FOR ORAL SUSPENSION_ _
_125 + 31.25 MG/5 ML _
Reconstituted suspension contains in 5 mL, Amoxicillin Trihydrate Ph.
Eur. equivalent to
amoxicillin 125 mg and Potassium Clavulanate Ph. Eur. equivalent to
clavulanic acid 31.25
mg.
_250 + 62.5 MG/5 ML _
Reconstituted suspension contains in 5 mL, Amoxicillin Trihydrate Ph.
Eur. equivalent to
amoxicillin 250 mg and Potassium Clavulanate Ph. Eur. equivalent to
clavulanic acid 62.5 mg.
_List of excipients with known effect:_
Aspartame.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
CURAM TABLET
Tablet, film-coated, oblong biconvex formed, off-white colour, scored
on both sides.
CURAM DUO 500/125 TABLET
Tablet, film-coated, oval biconvex formed, off-white colour, scored on
both sides.
CURAM POWDER FOR ORAL SUSPENSION
Suspension, oral, powder for, white to yellowish colour.
231013-Curam-ds-v1.0
Page 2 of 15
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Short-term treatment of common bacterial infections such as:
_UPPER RESPIRATORY TRACT INFECTIONS (INCLUDING ENT):_
e.g. tonsillitis, sinusitis, otitis media
_LOWER RESPIRATORY TRACT INFECTIONS:_
e.g. acute exacerbations of chronic bronchitis, lobar and
broncho-pneumonia
_GENITO-URINARY _
_TRACT _
_INFECTIONS:_
e.g.
cystitis,
urethritis,
pyelonephritis,
female
genital
infections
_SKIN AND SOFT TISSUE INFECTIONS _
_BONE AND JOINT INFECTIONS:_
e.g. osteomyelitis
_OTHER INFEC