Vancomycin 500 mg powder for concentrate for solution for infusion

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

VANCOMYCIN HYDROCHLORIDE

Tilgængelig fra:

Laboratórios Azevedos - Indústria Farmacêutica S.A

ATC-kode:

J01XA; J01XA01

INN (International Name):

VANCOMYCIN HYDROCHLORIDE

Dosering:

500 milligram(s)

Lægemiddelform:

Powder for concentrate for solution for infusion

Recept type:

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

Terapeutisk område:

Glycopeptide antibacterials; vancomycin

Autorisation status:

Marketed

Autorisation dato:

2016-04-29

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it
again.

If you have further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it 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
Vancomycin is and what it is used for
2. What you need to know before you use Vancomycin
3. How to use Vancomycin
4. Possible side effects
5. How to store
Vancomycin
6. Contents of the pack and other information
1. WHAT VANCOMYCIN IS AND WHAT IT IS USED FOR
Vancomycin is an antibiotic that belongs to a group of antibiotics
called “glycopeptides”.
Vancomycin works by eliminating certain bacteria that cause
infections.
Vancomycin
powder is made into a solution for infusion or an oral solution.
Vancomycin is used 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 the bones 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 the central nervous system.

Infection in the blood linked to the infections listed above.
Vancomycin can be given orally in adults and children for the
treatment of infection of the
mucosa of the small and the large intestines with damage to the
mucosae (pseudomembranous
colitis), caused by the
_Clostridium difficile _
bacterium.

Produktets egenskaber

Health Products Regulatory Authority
24 January 2022
CRN00C6M9
Page 1 of 14
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
Vancomycin 500 mg, Powder for concentrate for solution for infusion
Each vial contains 500 mg of vancomycin (as vancomycin hydrochloride),
equivalent to 500,000 IU vancomycin.
One ml of reconstituted solution contains 50 mg of vancomycin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Homogeneous solid, white to slightly brown.
After reconstitution a solution is obtained with a pH between 2.5 –
4.5.
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

bacteraemia that occurs in association with, or is suspected to be
associated with any of the above.
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.
Oral administration
Vancomycin is indicated in all age groups for the treatment of
_Clostridium difficile_ infection (CDI) (see sections 4.2, 4.4 and
5.1).
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 ach