TAZOCIN EF INJECTION 4.5G

Maa: Malesia

Kieli: englanti

Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiivinen ainesosa:

PIPERACILLIN; TAZOBACTAM

Saatavilla:

PFIZER (MALAYSIA) SDN. BHD.

INN (Kansainvälinen yleisnimi):

PIPERACILLIN; TAZOBACTAM

Kpl paketissa:

4.5 gm mcg/mL

Valmistaja:

Wyeth Lederle S.r.l

Valmisteyhteenveto

Pfizer Confidential
Pfizer Confidential
Page 1 of 17
TAZOCIN EF
(Piperacillin sodium/Tazobactam sodium)
1.
NAME OF THE MEDICINAL PRODUCT
TAZOCIN EF
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
3.
PHARMACEUTICAL FORM
Piperacillin/tazobactam powder for solution for injection or infusion
is a sterile, off-white to white
lyophilized cake or powder, contained in a glass vial.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Piperacillin/tazobactam 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.
Polymicrobic infections: piperacillin/tazobactam is indicated for
polymicrobic infections including
those where aerobic and anaerobic organisms are suspected
(intra-abdominal, skin and skin
structure, lower respiratory tract).
Piperacillin/tazobactam,
in
combination
with
an
aminoglycoside,
is
indicated
for
bacterial
infections in neutropenic adults or children.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Piperacillin/tazobactam must be given by slow intravenous infusion
(e.g. over 20-30 minutes) or
slow intravenous injection (over at least 3-5 minutes).
DURATION OF THERAPY
The duration of therapy should be guided by the severity of the
infection and the patient’s clinical
and bacteriological progress.
DOSAGE
Neutropenic patients with signs of infection (e.g. fever) should
receive immediate empirical
antibiotic therapy before laboratory results are available.
Pfizer Confidential
Page 2 of 17
_ADULTS AND CHILDREN AGED 12 YEARS AND OLDER: