Negaban 1g powder for solution for injection vials

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Temocillin sodium

Tilgjengelig fra:

Eumedica Pharma Ltd

ATC-kode:

J01CA17

INN (International Name):

Temocillin sodium

Dosering :

1gram

Legemiddelform:

Powder for solution for injection

Administreringsrute:

Intravenous; Intramuscular

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 05010102; GTIN: 05425025990078

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NEGABAN 1G, POWDER FOR SOLUTION FOR INJECTION OR INFUSION
Temocillin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 has been 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.
WHAT IS IN THIS LEAFLET
1.
What Negaban is and what it is used for
2.
What you need to know before you use Negaban
3.
How to use Negaban
4.
Possible side effects
5.
How to store Negaban
6.
Contents of the pack and other information
1.
WHAT NEGABAN IS AND WHAT IT IS USED FOR
Negaban is an antibiotic that contains the active substance
temocillin. It belongs to a group of antibiotics
called penicillins (beta-lactam family).. It works by killing some
types of bacteria that may cause infections.
Negaban is used to treat the following infections:
• bacterial infections of the chest and lungs,
• bacterial infections of the kidneys and bladder,
• other types of infections when there are bacteria in the
bloodstream.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NEGABAN
DO NOT USE NEGABAN
-
if you are allergic to temocillin.
-
if you ever had an allergic reaction to other antibiotics of the
beta-lactam family such as penicillins,
cephalosporins, carbapenems or monobactams.
If you are not sure, you should talk to your doctor, pharmacist or
nurse before you receive Negaban. This is
especially important if you have ever had an allergic reaction to any
antibiotic but you are not sure what type
of antibiotic it was.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Negaban.
-
if you have been told that your kidneys do not work normally.
-

Preparatomtale

OBJECT 1
NEGABAN 1 G, POWDER FOR SOLUTION FOR
INJECTION/INFUSION
Summary of Product Characteristics Updated 01-Mar-2018 | EUMEDICA SA
1. Name of the medicinal product
Negaban 1 g, powder for solution for injection/infusion.
2. Qualitative and quantitative composition
1 vial contains 1.11 g temocillin disodium, corresponding to 1 g
temocillin.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for injection/infusion.
Vial containing a white to pale yellow sterile solid.
4. Clinical particulars
4.1 Therapeutic indications
Negaban is indicated for the treatment of septicaemia, urinary tract
infection and lower respiratory tract
infection where susceptible gram-negative bacilli are suspected or
confirmed.
In mixed infections where gram-positive or anaerobic bacteria are also
liable to be implicated, co-
administration with other appropriate antibacterial agents should be
considered.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 Posology and method of administration
POSOLOGY
_PATIENTS WITH NORMAL RENAL FUNCTION_
Adults (including the elderly):
Usual dose: 4 g per day to be divided into 2 administrations or as
continuous infusion.
High dose notably in critically ill patients: 6 g per day to be
divided into 3 administrations or as
continuous infusion.
A loading dose of 2 g should be administered before starting the
continuous infusion (see Method of
administration).
Children: Insufficient data are available to recommend an appropriate
dosage regimen.
_PATIENTS WITH RENAL INSUFFICIENCY_
Adults (including the elderly):
Temocillin is mainly excreted renally and unchanged. Excretion is
reduced in renal impairment and half-
life is increased according to the severity of renal failure. In
moderate and severe renal failure, dose
adjustments are necessary in accordance with the following regimen:
Creatinine clearance (ml/min)
Posology : Usual dose
Dosage per administration
Interval between administrations
More than 60
2 g
12 h
60