Piperacillin 2g / Tazobactam 250mg powder for solution for infusion vials

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Piperacillin sodium; Tazobactam sodium

Tilgængelig fra:

Wockhardt UK Ltd

ATC-kode:

J01CR05

INN (International Name):

Piperacillin sodium; Tazobactam sodium

Dosering:

2gram ; 250mg

Lægemiddelform:

Powder for solution for infusion

Indgivelsesvej:

Intravenous

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 05010104; GTIN: 5012727905396

Indlægsseddel

Process Black
Keyline (non-printing)
MEASURE BAR SHOULD BE 150MM AT 100% SCALE
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[e-mail]
Wockhardt UK Limited
Pip/Taz Inj Powder for Sol for Infusion
103276/6
n/a
170mm x 540mm
MPI
1
22/05/2017
851708
n/a
9pt (Main Body) / 8pt (Variables)
UK
English
PACKAGE LEAFLET: INFORMATION FOR THE USER
PIPERACILLIN/TAZOBACTAM 2 G/0.25 G POWDER FOR SOLUTION
FOR INFUSION
PIPERACILLIN/TAZOBACTAM 4 G/0.5 G POWDER FOR SOLUTION
FOR INFUSION
PIPERACILLIN (AS SODIUM) WITH TAZOBACTAM (AS SODIUM)
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING
THIS
MEDICINE
BECAUSE
IT
CONTAINS
IMPORTANT
INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again
• If
you
have
any
further
questions,
ask
your
doctor,
pharmacist or nurse.
• This medicine is prescribed for you only. Do not pass it on
to others. It may harm them, even if their signs of illness are
the same as yours
• If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in
this leaflet. See section 4.
THE NAME OF YOUR MEDICINE IS PIPERACILLIN/TAZOBACTAM
2 G/0.25 G AND 4 G/0.5 G POWDER FOR SOLUTION FOR INFUSION.
_In the rest of this leaflet Piperacillin/Tazobactam 2 g/0.25 g and _
_4 g/0.5 g Powder for Solution for Infusion is called Piperacillin _
_with Tazobactam._
WHAT IS IN THIS LEAFLET:
1. What Piperacillin with Tazobactam is and what it is used for
2. What you need to know before you are given Piperacillin
with Tazobactam
3. How Piperacillin with Tazobactam is given
4. Possible side effects
5. How to store Piperacillin with T

Produktets egenskaber

OBJECT 1
PIPERACILLIN/TAZOBACTAM 2G/0.25G POWDER FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 04-Aug-2017 | Wockhardt UK
Ltd
1. Name of the medicinal product
Piperacillin/Tazobactam 2 g/0.25 g Powder for Solution for Infusion.
2. Qualitative and quantitative composition
Each vial contains 2 g piperacillin (as sodium salt) and 0.25 g
tazobactam (as sodium salt).
One vial of powder for solution for infusion contains 4.72 mmol (109
mg) of sodium.
For a full list of excipients see section 6.1.
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
eight hours.
For nosocomial pneumonia and bacterial infection