TAZOCIN 4/0.5 Grams Pdr for Soln for Infusion

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

PIPERACILLIN SODIUM TAZOBACTAM SODIUM

Доступно од:

Pfizer Healthcare Ireland

INN (Међународно име):

PIPERACILLIN SODIUM TAZOBACTAM SODIUM

Дозирање:

4/0.5 Grams

Фармацеутски облик:

Pdr for Soln for Infusion

Тип рецептора:

Product subject to prescription which may not be renewed (A)

Статус ауторизације:

Authorised

Датум одобрења:

0000-00-00

Информативни летак

8930066 RD
PhC 48
PACKAGE LEAFLET: INFORMATION FOR THE USER
TAZOCIN
®

2 G / 0.25 G POWDER FOR SOLUTION FOR INFUSION
TAZOCIN
®

4 G / 0.5 G POWDER FOR SOLUTION FOR INFUSION
PIPERACILLIN / TAZOBACTAM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 
THIS MEDICINE.
-  Keep this leaflet. You may need to read it again.
-  If you have any further questions, ask your doctor or pharmacist.
-  This medicine has been prescribed for you. Do not pass it 
on to others. It may harm them, even if their symptoms are 
the same as yours.
-  If any of the side effects gets serious, or if you notice any 
side effects not listed in this leaflet, please tell your doctor 
or pharmacist.
1. What TAZOCIN is and what it is used for
2.  Before you use TAZOCIN
3.  How to use TAZOCIN
4.  Possible side effects
5.  How to store TAZOCIN 
6.  Further information
Piperacillin belongs to the group of medicines known as 
“broad-spectrum penicillin antibiotics”. It can kill many kinds 
of bacteria. Tazobactam can prevent some resistant bacteria 
from surviving the effects of piperacillin. This means that 
when piperacillin and tazobactam are given together, more 
types of bacteria are killed.
TAZOCIN is used in adults and adolescents to treat bacterial 
infections, such as those affecting the lower respiratory tract 
(lungs), urinary tract (kidneys and bladder), abdomen, skin or 
blood. TAZOCIN may be used to treat bacterial infections in 
patients with low white blood cell counts (reduced resistance 
to infections).
The following information is intended for medical or healthcare
professionals only:
✪ 
INSTRUCTIONS FOR USE
TAZOCIN will be given by intravenous infusion (a drip for
30 minutes).
✪ 
INTRAVENOUS USE
Reconstitute each vial with the volume of solvent shown in the table
below, using one 
of the compatible solvents for reconstitution. Swirl until dissolved.
When swirled con-
stantly, reconstitution generally occurs within 5 to 10 minutes (for

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tazocin 4 g/0.5 g powder for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains piperacillin (as sodium salt) equivalent to 4 g and tazobactam (as sodium salt) equivalent to 0.5 g.
Each vial of Tazocin 4 g / 0.5 g contains 11.16 mmol (256 mg) of sodium.
Excipients:
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
Tazocin 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.
Tazocin 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
Tazocin 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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 04/02/2014_
_CRN 2139390_
_page number: 1_
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The dose and frequency of Tazocin depends on�