Silgram 500mg/ 250mg Powder for Injection (IM/IV)

Χώρα: Φιλιππίνες

Γλώσσα: Αγγλικά

Πηγή: FDA (Food And Drug Administration)

Δραστική ουσία:

Ampicillin (as Sodium) , Sulbactam (as Sodium)

Διαθέσιμο από:

The Cathay Drug Co., Inc.

INN (Διεθνής Όνομα):

Ampicillin (as Sodium) + Sulbactam (as Sodium)

Δοσολογία:

500mg/ 250mg

Φαρμακοτεχνική μορφή:

Powder for Injection (IM/IV)

Μονάδες σε πακέτο:

1 Clear glass vial with secondary box

Κατασκευάζεται από:

YSS Laboratories Co., Inc., Philippines

Ημερομηνία της άδειας:

2017-04-26

Φύλλο οδηγιών χρήσης

SILGRAM
AMPICILLIN SODIUM + SULBACTAM SODIUM
250 mg/125 mg
500 mg/230 mg
1 g/500 mg (I.M./I.V.)
Sterile Powder for Injection
ANTIBACTERIAL
DESCRIPTION
FORMULATION
Each vial contains:
Ampicillin (as sodium) …………………….. 250 mg
Sulbactam (as sodium) …………………… 125 mg
Each vial contains:
Ampicillin (as sodium) …………………….. 500 mg
Sulbactam (as sodium) …………………… 250 mg
Each vial contains:
Ampicillin (as sodium) …………………….. 1 g
Sulbactam (as sodium) …………………… 500 mg
DESCRIPTION
AMPICILLIN SODIUM
Ampicillin sodium/Sulbactam sodium (Silgram) is an injectable
antibacterial combination
consisting of the semisynthetic antibiotic Ampicillin sodium and the
beta-lactamase inhibitor
Sulbactam sodium for intravenous and intramuscular administration.
Ampicillin sodium is derived
fromt eh penicillin nucleus, 6-aminopenicillinic acid. Chemically, it
is monosodium (2S, 5R, 6R)-6-
{®-2-amino-2-phenylacetamido}-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]
heptane-2-
carboxylate and has a molecular weight of 371.39. Its chemical formula
is C16H18N3NaO4S.
SULBACTAM SODIUM
Sulbactam sodium is a derivatinve of the basic penicillin nucleus.
Chemically, Sulbactam sodium is
a sodium penicillinate sulfone; sodium (2S,
5R)-3,3-dimethyl-7-oxo–4-thia-1-azabicyclo[3.2.0]
heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S
with a molecular
weight of 255.22.
CLINICAL PHARMACOLOGY
Immediately after completions of a 15-minute intravenous infusion of
Ampicillin sodium/Sulbactam
sodium (Silgram), peak serum concentrations of ampicillin and
sulbactam are obtained. Ampicillin
serum levels are similar to those produced by the administration of
equivalent amounts of ampicillin
alone. The mean serum half-life of both drug is approximately 1 hour
in healthy volunteers.
Approximately 75 to 85% of both ampicillin and sulbactam are excreted
unchanged in the urine
during the first 8 hours after administration of Ampicillin
sodium/Sulbactam sodium (SILGR