Vancomycin 1000 mg Powder for concentrate for solution for infusion and oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

VANCOMYCIN HYDROCHLORIDE

Available from:

Noridem Enterprises Limited

ATC code:

J01XA; J01XA01

INN (International Name):

VANCOMYCIN HYDROCHLORIDE

Dosage:

1000 milligram(s)

Pharmaceutical form:

Powder for concentrate for solution for infusion

Prescription type:

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

Therapeutic area:

Glycopeptide antibacterials; vancomycin

Authorization status:

Marketed

Authorization date:

2011-06-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
VANCOMYCIN 500 MG & 1000 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION AND
ORAL SOLUTION
VANCOMYCIN HYDROCHLORIDE
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 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 or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
THE NAME OF YOUR MEDICINE IS ONE OF THE FOLLOWING:
-
Vancomycin 500 mg Powder for concentrate for solution for infusion and
oral solution
-
Vancomycin 1000 mg Powder for concentrate for solution for infusion
and oral solution
_In the rest of this leaflet your medicine is called Vancomycin. _
_ _
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 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.
Vancomycin powder is made into a solution for infusion or 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 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.
Vancomycin can be gi

Summary of Product characteristics

Health Products Regulatory Authority
15 December 2023
CRN00DYLT
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vancomycin 1000 mg Powder for concentrate for solution for infusion
and oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1000 mg vancomycin hydrochloride equivalent to
1,000,000 IU vancomycin.
When reconstituted with 20 mL of water for injections, the resulting
concentrate for solution for infusion contains 50 mg/mL
vancomycin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion and oral solution.
A white to pinkish powder.
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

acute bacterial meningitis
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
_Clostridioides 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 adm