Cefoxitin Actavis

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

Cefoxitin sodium 1 g

제공처:

Teva Pharma (New Zealand) Limited

INN (국제 이름):

Cefoxitin sodium 1 g

복용량:

1 g

약제 형태:

Powder for injection

구성:

Active: Cefoxitin sodium 1 g

패키지 단위:

Vial, glass, single dose, Vial, powder for inj. 1g, 5 dose units

수업:

Prescription

처방전 유형:

Prescription

Manufactured by:

ACS Dobfar SpA

치료 징후:

Cefoxitin Actavis is indicated for the treatment of the following infections when due to susceptible organisms (see Microbiology) peritonitis and other intra-abdominal and intra-pelvic infections, female genital tract infections, septicaemia, endocarditis, urinary tract infections, respiratory tract infections, bone and joint infections, skin and skin structure infections. Cefoxitin Actavis has a high degree of stability against beta-lactamase and is therefore effective against beta-lactamase producing organisms resistant to penicillins or cephalosporins. It can also be used in mixed infections provided that the organisms are sensitive to it. Cefoxitin Actavis can be used as adjunctive therapy in the surgical treatment of infections including abscesses, infection complicating hollow viscus perforations, cutaneous infections and infections of serous surfaces whether caused by aerobes, mixed aerobes and anaerobes, or anaerobes.

제품 요약:

Package - Contents - Shelf Life: Vial, glass, single dose, Vial, powder for inj. 1g - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 36 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 6 hours reconstituted stored at or below 30°C protect from light - Vial, glass, single dose, Vial, powder for inj. 1g - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 36 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 6 hours reconstituted stored at or below 30°C protect from light

승인 날짜:

1993-03-30

제품 특성 요약

Version 1.0
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Cefoxitin Actavis, Powder for Injection 1g and 2g
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains cefoxitin sodium equivalent to 1 g or 2 g of
cefoxitin.
Each gram of cefoxitin sodium contains approximately 51.2 mg (2.2 mEq)
of sodium. The pH of 10%
w/v cefoxitin sodium in Water for Injections is 4.2 to 7.0.
3.
PHARMACEUTICAL FORM
Cefoxitin Actavis is a white to slightly yellow sterile powder of
cefoxitin sodium for intravenous and
intramuscular administration following reconstitution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cefoxitin Actavis is indicated for the treatment of the following
infections when due to susceptible
organisms (see
MICROBIOLOGY)
peritonitis and other intra-abdominal and intra-pelvic infections,
female genital tract infections, septicaemia, endocarditis, urinary
tract infections, respiratory tract
infections,
bone
and
joint
infections,
skin
and
skin
structure
infections.
Cefoxitin Actavis has a high degree of stability against ß-lactamase
and is therefore effective against
ß-lactamase producing organisms resistant to penicillins or
cephalosporins. It can also be used in
mixed infections provided that the organisms are sensitive to it.
Cefoxitin Actavis can be used as adjunctive therapy in the surgical
treatment of infections including
abscesses, infection complicating hollow viscus perforations,
cutaneous infections and infections of
serous surfaces whether caused by aerobes, mixed aerobes and
anaerobes, or anaerobes.
Cefoxitin Actavis is also indicated for the prevention of
post-operative infections associated with
certain surgical procedures of the gastrointestinal, biliary and
genital tracts.
4.2
DOSE AND METHOD OF ADMINISTRATION
TREATMENT
Cefoxitin Actavis may be administered intravenously or intramuscularly
(see reconstitution directions
for each route below). Dosage and route of administration are
determined by severity of infection,
susceptibility of the causative organisms, and condition of the
patient