UNASYN 3000 FOR INJECTION

Pays: Singapour

Langue: anglais

Source: HSA (Health Sciences Authority)

Ingrédients actifs:

AMPICILLIN SODIUM EQV AMPICILLIN; SULBACTAM SODIUM EQV SULBACTAM

Disponible depuis:

PFIZER PRIVATE LIMITED

Code ATC:

J01CR01

Dosage:

2 g/vial

forme pharmaceutique:

INJECTION, POWDER, FOR SOLUTION

Composition:

AMPICILLIN SODIUM EQV AMPICILLIN 2 g/vial; SULBACTAM SODIUM EQV SULBACTAM 1 g/vial

Mode d'administration:

INTRAVENOUS, INTRAMUSCULAR

Type d'ordonnance:

Prescription Only

Fabriqué par:

Haupt Pharma Latina S.r.L

Statut de autorisation:

ACTIVE

Date de l'autorisation:

1988-06-23

Résumé des caractéristiques du produit

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