Curam

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

Amoxicillin sodium 1.06 g equivalent to amoxicillin 1 g - as part of a 5:1 mix;  ; Potassium clavulanate 238.3mg equivalent to clavulanic acid 200 mg - as part of a 5:1 mix

제공처:

Sandoz New Zealand Limited

INN (International Name):

Amoxicillin sodium 1.06 g (=amoxicillin 1 g - as part of a 5:1 mix)

복용량:

1000/200mg

약제 형태:

Powder for injection

구성:

Active: Amoxicillin sodium 1.06 g equivalent to amoxicillin 1 g - as part of a 5:1 mix   Potassium clavulanate 238.3mg equivalent to clavulanic acid 200 mg - as part of a 5:1 mix

패키지 단위:

Vial, glass, single dose, Type II, 20mL, 10 dose units

수업:

Prescription

처방전 유형:

Prescription

Manufactured by:

Sandoz Industrial Products SA

치료 징후:

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, 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 amoxicillin susceptible organisms are amenable to amoxicillin/clavulanic acid treatment due to its amoxicillin content. Mixed infections caused by amoxicillin susceptible organisms in conjunction with amoxicillin/clavulanic acid susceptible beta-lactamase-producing organisms may therefore be treated by amoxicillin/clavulanic acid.

제품 요약:

Package - Contents - Shelf Life: Vial, glass, single dose, Type II, 20mL - 1 dose units - 24 months from date of manufacture stored at or below 25°C 20 minutes reconstituted stored at or below 25°C. with water for injection - Vial, glass, single dose, Type II, 20mL - 5 dose units - 24 months from date of manufacture stored at or below 25°C 20 minutes reconstituted stored at or below 25°C. with water for injection - Vial, glass, single dose, Type II, 20mL - 10 dose units - 24 months from date of manufacture stored at or below 25°C 20 minutes reconstituted stored at or below 25°C. with water for injection - Vial, glass, single dose, Type II, 20mL - 20 dose units - 24 months from date of manufacture stored at or below 25°C 20 minutes reconstituted stored at or below 25°C. with water for injection - Vial, glass, single dose, Type II, 20mL - 50 dose units - 24 months from date of manufacture stored at or below 25°C 20 minutes reconstituted stored at or below 25°C. with water for injection

승인 날짜:

2002-08-26

제품 특성 요약

230320-curam-ds
Page 1 of 15
NEW ZEALAND DATA SHEET
CURAM
® (AMOXICILLIN/CLAVULANIC ACID) POWDER FOR INJECTION
1.
PRODUCT NAME
Curam 500/100 powder for injection
Curam 1000/200 powder for injection
Curam 2000/200 powder for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Curam 500/100 powder for injection: Each vial contains amoxicillin
sodium equivalent to
500 mg amoxicillin and potassium
clavulanate equivalent to 100 mg clavulanic acid. Each
vial contains 0.5 mmoL (19.6 mg) of potassium and 1.4 mmoL (31.4 mg)
of sodium.
Curam 1000/200 powder for injection: Each vial contains amoxicillin
sodium equivalent to
1000 mg amoxicillin and potassium clavulanate equivalent to 200 mg
clavulanic acid. Each
vial contains 1.0 mmoL (39.3 mg) of potassium and 2.7 mmoL (62.9 mg)
of sodium.
Curam 2000/200 powder for injection: Each vial contains amoxicillin
sodium equivalent to
2000 mg amoxicillin and potassium clavulanate equivalent to 200 mg
clavulanic acid. Each
vial contains 1.0 mmoL (39.3 mg) of potassium and 5.5 mmoL (125.9 mg)
of sodium.
Curam contains no excipients.
3.
PHARMACEUTICAL FORM
Powder for injection.
Vials containing a sterile white to off-white powder.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Curam should be used in accordance with local official
antibiotic-prescribing guidelines and
local susceptibility data.
Curam is indicated for the short term treatment of common bacterial
infections in adults and
children 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, post-surgical infections
230320-curam-ds
Page 2 of 15
Curam is indica