Vancocin 1 g powder for concentrate for solution for infusion and powder for oral solution

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Vancomycin

Saatavilla:

Flynn Pharma Limited

ATC-koodi:

J01XA; J01XA01

INN (Kansainvälinen yleisnimi):

Vancomycin

Annos:

1 gram(s)

Lääkemuoto:

Powder for concentrate for solution for infusion

Prescription tyyppi:

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

Terapeuttinen alue:

Glycopeptide antibacterials; vancomycin

Valtuutuksen tilan:

Not marketed

Valtuutus päivämäärä:

2010-06-11

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
VANCOCIN 500 MG & 1 G POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
AND POWDER FOR
ORAL SOLUTION
Vancomycin hydrochloride
The name of your medicine is Vancocin 500 mg & 1 g Powder for
Concentrate for Solution for
Infusion and Powder for Oral Solution, which will be referred to as
Vancocin throughout the rest of
this document.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Vancocin is and what it is used for
2.
What you need to know before you are given Vancocin
3.
How you are given Vancocin
4.
Possible side effects
5.
How to store Vancocin
6.
Contents of the pack and other information
1.
WHAT VANCOCIN IS AND WHAT IT IS USED FOR
Vancocin contains the active ingredient vancomycin. Vancomycin is an
antibiotic that belongs to a
group of antibiotics called “glycopeptides”. Vancomycin works by
eliminating certain bacteria that
cause infections.
Vancocin powder is made into a solution for infusion or oral solution.
Vancocin 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 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.
Vancocin 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

Valmisteyhteenveto

Health Products Regulatory Authority
23 June 2022
CRN00CYCS
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vancocin 1 g powder for concentrate for solution for infusion and
powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 g vancomycin hydrochloride equivalent to
1,000,000 IU vancomycin. When reconstituted with 20 mL water
for injections, the concentrate for solution contains vancomycin 50
mg/mL.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion and powder for oral
solution.
An off-white lyophilised plug, when reconstituted in water, it forms a
clear solution.
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.
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 achieve targeted therapeutic concentrations. Renal
function must be taken into consideration for subsequent
doses and interval of administra