Država: Nova Zelandija
Jezik: angleščina
Source: Medsafe (Medicines Safety Authority)
Amoxicillin sodium 530.1mg equivalent to amoxicillin 500 mg as part of a 5:1 mix; ; Potassium clavulanate 119.2mg equivalent to clavulanic acid 100 mg - as part of a 5:1 mix
Sandoz New Zealand Limited
Amoxicillin sodium 530 mg (= amoxicillin 500 mg as part of a 5:1 mix)
500/100mg
Powder for injection
Active: Amoxicillin sodium 530.1mg equivalent to amoxicillin 500 mg as part of a 5:1 mix Potassium clavulanate 119.2mg equivalent to clavulanic acid 100 mg - as part of a 5:1 mix
Vial, glass, single dose, Type II, 20mL, 10 dose units
Prescription
Prescription
Sandoz Industrial Products SA
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.
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
2002-08-26
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 Preberite celoten dokument