Vancomycin 500 mg powder for concentrate for solution for infusion

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

VANCOMYCIN HYDROCHLORIDE

Dostopno od:

Fresenius Kabi Limited

Koda artikla:

J01XA; J01XA01

INN (mednarodno ime):

VANCOMYCIN HYDROCHLORIDE

Odmerek:

500 milligram(s)

Farmacevtska oblika:

Pdr/Conc/Soln for Infus

Tip zastaranja:

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

Terapevtsko območje:

Glycopeptide antibacterials; vancomycin

Status dovoljenje:

Not marketed

Datum dovoljenje:

2011-09-16

Navodilo za uporabo

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VANCOMYCIN [NATIONAL COMPLETED NAME] 500 MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
VANCOMYCIN [NATIONAL COMPLETED NAME] 1000 MG POWDER FOR CONCENTRATE
FOR SOLUTION FOR INFUSION
Vancomycin
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 or pharmacist.

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 or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Vancomycin [national completed name] is and what it is used for
2.
What you need to know before you use Vancomycin [national completed
name]
3.
How to use Vancomycin [national completed name]
4.
Possible side effects
5.
How to store Vancomycin [national completed name]
6.
Contents of the pack and other information
1.
WHAT VANCOMYCIN [NATIONAL COMPLETED NAME] IS AND WHAT IT IS USED FOR
Vancomycin [national completed name] is an antibiotic that belongs to
a group of antibiotics called
“glycopeptides”. Vancomycin [national completed name] works by
eliminating certain bacteria that cause
infections.
Vancomycin powder is made into a solution for infusion.
Vancomycin is used in in all age groups by infusion for the treatment
of the following serious infections:
-
Infections of the skin and tissues below the skin.
-
Infections of bone and joints.
-
An infection of the lungs called "pneumonia".
-
Infection of the inside lining of the heart (endocarditis) and to
prevent endocarditis in patients at risk
when undergoing major surgical procedures
-
Infection in central nervous system.
-
Infection in the

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vancomycin 500 mg powder for concentrate for solution for infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 mg vancomycin hydrochloride equivalent to
500,000 IU vancomycin.
3 PHARMACEUTICAL FORM
Powder for Concentrate for Solution for Infusion
A white to cream coloured porous cake.
After reconstitution a solution is obtained with a pH of approximately
3.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Intravenous administration
Vancomycin is indicated in all age groups for the treatment of the
following infections (see sections 4.2, 4.4 and 5.1):
-
complicated skin and soft tissue infections (cSSTI)
-
bone and joint infections
-
community acquired pneumonia (CAP)
-
hospital acquired pneumonia (HAP), including ventilator-associated
pneumonia (VAP)
-
infective endocarditis
Vancomycin is also indicated in all age groups for the perioperative
antibacterial prophylaxis in patients that are at high
risk of developing bacterial endocarditis when undergoing major
surgical procedures.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Where appropriate, vancomycin should be administered in combination
with other antibacterial agents.
_Intravenous administration_
The initial
dose should be based on total
body weight.
Subsequent
dose adjustments should be based on serum
concentrations to achieve targeted therapeutic concentrations.
Renal
function must
be taken into consideration for
subsequent doses and interval of administration.
_Patients aged 12 years and older:_
The recommended dose is 15 to 20 mg/kg of body weight every 8 to 12 h
(not to exceed 2 g per dose).
In seriously ill patients,
a loading dose of 25–30 mg/kg of body weight can be used to
facilitate rapid attainment
of
target trough serum vancomycin concentration.
_Infants and children aged from one month to less than 12 years of
age:_
The recommended dose is 10 to 15