TAZOCIN FOR INJECTION 4.5 gvial

Land: Singapore

Språk: engelska

Källa: HSA (Health Sciences Authority)

Aktiva substanser:

PIPERACILLIN SODIUM 4170 mg EQV PIPERACILLIN; TAZOBACTAM SODIUM 536.6 mg/vial EQV TAZOBACTAM

Tillgänglig från:

PFIZER PRIVATE LIMITED

ATC-kod:

J01CR05

Läkemedelsform:

INJECTION, POWDER, FOR SOLUTION

Sammansättning:

PIPERACILLIN SODIUM 4170 mg EQV PIPERACILLIN 4000 mg/vial; TAZOBACTAM SODIUM 536.6 mg/vial EQV TAZOBACTAM 500 mg/vial

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

Prescription Only

Tillverkad av:

Wyeth Lederle S.r.l

Bemyndigande status:

ACTIVE

Tillstånd datum:

1995-10-03

Produktens egenskaper

1. NAME OF THE MEDICINAL PRODUCT
Tazocin for Injection 4.5 g/vial
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Piperacillin sodium/tazobactam sodium (INN).
CHEMICAL NAME
Piperacillin sodium is sodium
(2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazinecarboxamido)-2-
phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate.
Tazobactam sodium is sodium
(2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-
azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide.
STRUCTURE
Piperacillin sodium
Tazobactam sodium
MOLECULAR FORMULA
Piperacillin sodium: C
23
H
26
N
5
NaO
7
S; tazobactam sodium: C
10
H
11
N
4
NaO
5
S.
MOLECULAR WEIGHT
Piperacillin sodium: 539.5; tazobactam sodium: 322.3.
PHYSICAL CHARACTERISTICS
Vial containing a white to off-white sterile, lyophilized powder of
piperacillin and tazobactam as the
sodium salts.
VIALS WITH LYOPHILIZED POWDER FOR RECONSTITUTION
Each vial contains a total of 2.84 mEq (65 mg) of sodium per gram of
piperacillin.
4.5 g vial: Each single-dose vial contains piperacillin sodium
equivalent to 4 g of piperacillin and
tazobactam sodium equivalent to 0.5 g of tazobactam. It also contains
1 mg of edetate disodium
(dihydrate) (EDTA) per vial.
N
N
CH
3
N
CH
2
S
O
O
COONa
O
H
H
N
CH
3
H
2 5
C H
N
NHCO
C
H
CONH
O
O
O
N
COONa
H
H
N
CH
3
3. PHARMACEUTICAL FORM
Sterile, lyophilized powder for solution for injection or infusion.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
TAZOCIN is indicated for the treatment of the following systemic
and/or local bacterial infections in
which susceptible organisms have been detected or are suspected:

Lower respiratory tract infections; urinary tract infections
(complicated and uncomplicated);
intra-abdominal infections; skin and skin structure infections;
bacterial septicemia.

Polymicrobial infections: TAZOCIN is indicated for polymicrobial
infections including those
where
aerobic
and
anaerobic
organisms
are
suspected
(intra-abdominal,
skin
and
skin
structure, lower respiratory tract).
TAZOCIN,
in
combination