Vancomycin 500 mg powder for concentrate for solution for infusion

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

VANCOMYCIN HYDROCHLORIDE

Dostupno od:

Fresenius Kabi Deutschland GmbH

ATC koda:

J01XA; J01XA01

INN (International ime):

VANCOMYCIN HYDROCHLORIDE

Doziranje:

500 milligram(s)

Farmaceutski oblik:

Powder for concentrate for solution for infusion

Područje terapije:

Glycopeptide antibacterials; vancomycin

Status autorizacije:

Not marketed

Datum autorizacije:

2011-09-16

Uputa o lijeku

UK-IE -PIL-Vancomycin-500mg-1000mg-psusa-V017-Jan-2021-Clean
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VANCOMYCIN 500 MG
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
VANCOMYCIN 1000 MG
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
vancomycin hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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.

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 infusion is and what it is used for
2.
What you need to know before you are given Vancomycin infusion
3.
How Vancomycin infusion is given
4.
Possible side effects
5.
How to store Vancomycin infusion
6.
Contents of the pack and other information
1.
WHAT VANCOMYCIN INFUSION IS AND WHAT IT IS USED FOR
Vancomycin infusion is a medicine that belongs to a group of
antibiotics called “glycopeptides”. Vancomycin
infusionworks by eliminating certain bacteria that cause infections.
Vancomycin powder is made into a solution for infusion or oral
solution.
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.
Vancomycin can be given orally in all age groups for the treament of
infection of the mucosa of the small and
the large intestines with damage to the mucosae (pseudomembranous
colitis), caused by the
_Clostridioides _
_difficile_
bacterium.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN VANCOMYCIN INFUSION
YOU MUST NOT BE GIVEN VANCOMYCIN INFUSION:

If you are allergic to vancomyci

Svojstava lijeka

Health Products Regulatory Authority
07 December 2021
CRN00C5WF
Page 1 of 13
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. When reconstituted with 10 ml
water for injections, the concentrate for solution contains vancomycin
hydrochloride 50 mg/ml.
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