Curam Duo 500/125

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

有効成分:

Amoxicillin trihydrate 574mg equivalent to Amoxycillin 500 mg;  ; Potassium clavulanate 149mg equivalent to Clavulanic acid 125 mg;  

から入手可能:

Sandoz New Zealand Limited

INN（国際名）:

Amoxicillin trihydrate 574 mg (=Amoxycillin 500 mg)

投薬量:

500mg/125mg

医薬品形態:

Film coated tablet

構図:

Active: Amoxicillin trihydrate 574mg equivalent to Amoxycillin 500 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

パッケージ内のユニット:

Aluminium foil, PE internal coat, 10 tablets

クラス:

Prescription

処方タイプ:

Prescription

製:

Sandoz Industrial Products SA

適応症:

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.

製品概要:

Package - Contents - Shelf Life: Aluminium foil, PE internal coat - 10 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture - Aluminium foil, PE internal coat - 15 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture - Aluminium foil, PE internal coat - 21 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture - Aluminium foil, PE internal coat - 50 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture - Aluminium foil, PE internal coat - 80 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture - Aluminium foil, PE internal coat - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture - Blister pack, Al/Al - 10 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture - Blister pack, Al/Al - 15 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture - Blister pack, Al/Al - 21 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture - Blister pack, Al/Al - 50 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture - Blister pack, Al/Al - 80 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture - Blister pack, Al/Al - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture

承認日:

1998-11-10

情報リーフレット

Curam Duo 500/125 CMI v1.0
1
CURAM DUO 500/125 TABLETS
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 CURAM DUO 500/125?
Curam Duo 500/125 contains the active ingredient potassium
clavulanate/amoxicillin trihydrate. Curam Duo 500/125 is used
for the short-term treatment of infections in different parts of the
body caused by bacteria.
For more information, see Section 1. Why am I using Curam Duo 500/125?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CURAM DUO 500/125?
Do not use if you have ever had an allergic reaction to Curam Duo
500/125 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
Curam Duo 500/125? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Curam Duo 500/125 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 CURAM DUO 500/125?
The usual dose may depend on the type of infection and how severe it
is.
More instructions can be found in Section 4. How do I use Curam Duo
500/125? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CURAM DUO 500/125?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, pharmacist or nurse you visit that you are
using Curam Duo 500/125.
•
Keep taking this medicine for the full time of treatment, even if you
begin to feel better after a few
days.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking Curam Duo 500/125 because you are feeling better,
unless advised by your doctor.
•
Do not give Curam Duo 500/125 to anyone else, even if they have the
same condition as you.
•
Do not use Curam Duo 500/125 to treat any other complaints unless your
doctor tells you to.
DRIVING OR USI

製品の特徴

240412-Curam-ds-v2.0
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.
240412-Curam-ds-v2.0
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