UNASYN 1500 FOR INJECTION

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

AMPICILLIN SODIUM EQV AMPICILLIN; SULBACTAM SODIUM EQV SULBACTAM

Διαθέσιμο από:

PFIZER PRIVATE LIMITED

Φαρμακολογική κατηγορία (ATC):

J01CR01

Δοσολογία:

1 g/vial

Φαρμακοτεχνική μορφή:

INJECTION, POWDER, FOR SOLUTION

Σύνθεση:

AMPICILLIN SODIUM EQV AMPICILLIN 1 g/vial; SULBACTAM SODIUM EQV SULBACTAM 500 mg/vial

Οδός χορήγησης:

INTRAVENOUS, INTRAMUSCULAR

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

Haupt Pharma Latina S.r.L

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

1988-06-23

Αρχείο Π.Χ.Π.

PFIZER
UNASYN
(Sulbactam Sodium/Ampicillin Sodium)
For Intravenous or Intramuscular Use
1.0
NAME OF THE MEDICINAL PRODUCT
UNASYN IM/IV
2.0
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sulbactam sodium is a derivative of the basic penicillin nucleus.
Chemically it is sodium
penicillanate sulfone and is an off-white crystalline powder highly
soluble in water. The
molecular weight is 255.22.
Ampicillin sodium is derived from the penicillin nucleus,
6-aminopenicillanic acid.
Chemically, it is D(-)-

-aminobenzyl penicillin sodium salt and has a molecular weight of
371.39.
Sulbactam sodium/ampicillin sodium IM/IV contains sulbactam sodium and
ampicillin
sodium in a 1:2 ratio.
3.0
PHARMACEUTICAL FORM
Sulbactam sodium/ampicillin sodium IM/IV combination is available as a
dry powder for
reconstitution in vials containing the equivalent of 1,000 mg + 2,000
mg, 500 mg + 1,000 mg,
250 mg + 500 mg of sulbactam and ampicillin, respectively.
4.0
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sulbactam sodium/ampicillin sodium IM/IV is indicated for infections
caused by susceptible
microorganisms. Typical indications are upper and lower respiratory
tract infections including
sinusitis, otitis media and epiglottitis; bacterial pneumonias;
urinary tract infections and
pyelonephritis; intra-abdominal infections including peritonitis,
cholecystitis, endometritis
and pelvic cellulitis; bacterial septicemia; skin, soft tissue, bone
and joint infections and
gonococcal infections.
Sulbactam sodium/ampicillin sodium IM/IV may also be administered
peri-operatively to
reduce the incidence of post-operative wound infections in patients
undergoing abdominal or
pelvic surgery, in which peritoneal contamination may be present. In
termination of
pregnancy or cesarean section, sulbactam sodium/ampicillin sodium
IM/IV may be used
prophylactically to reduce post-operative sepsis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Sulbactam sodium/ampicillin sodium IM/IV can be administered by either
intravenous or
intramuscular routes. The following dilu