Piperacillin 4g / Tazobactam 500mg powder for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Piperacillin sodium; Tazobactam sodium

Available from:

Milpharm Ltd

ATC code:

J01CR05

INN (International Name):

Piperacillin sodium; Tazobactam sodium

Dosage:

4gram ; 500mg

Pharmaceutical form:

Powder for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010104; GTIN: 8901175032006

Summary of Product characteristics

OBJECT 1
PIPERACILLIN/TAZOBACTAM 4 G / 0.5 G POWDER FOR
SOLUTION FOR INJECTION OR INFUSION
Summary of Product Characteristics Updated 08-Aug-2017 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Piperacillin/Tazobactam 4 g / 0.5 g powder for solution for infusion
2. Qualitative and quantitative composition
Each vial contains piperacillin (as sodium salt) equivalent to 4g
piperacillin and tazobactam as sodium
salt equivalent to 0.5g tazobactam.
One vial of powder for solution forinfusion contains 9.4 mmol (216mg)
of sodium.
3. Pharmaceutical form
Powder for solution for infusion.
White to off-white powder.
4. Clinical particulars
4.1 Therapeutic indications
Piperacillin/Tazobactam is indicated for the treatment of the
following infections in adults and children
over 2 years of age (see sections 4.2 and 5.1):
ADULTS AND ADOLESCENTS
- Severe pneumonia including hospital-acquired and
ventilator-associated pneumonia
- Complicated urinary tract infections (including pyelonephritis)
- Complicated intra-abdominal infections
- Complicated skin and soft tissue infections (including diabetic foot
infections)
Treatment of patients with bacteraemia that occurs in association
with, or is suspected to be associated
with, any of the infections listed above.
Piperacillin/Tazobactam may be used in the management of neutropenic
patients with fever suspected to
be due to a bacterial infection.
CHILDREN 2 TO 12 YEARS OF AGE
- Complicated intra-abdominal infections
Piperacillin/Tazobactam may be used in the management of neutropenic
children with fever suspected to
be due to a bacterial infection.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 Posology and method of administration
POSOLOGY
The dose and frequency of Piperacillin/Tazobactam depends on the
severity and localisation of the
infection and expected pathogens.
_Adult and adolescent patients _
_Infections _
The usual dose is 4 g piperacillin / 0.5 g tazobactam given every 8
hours.
For nosocomial pneumon