VANCOMYCIN

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

VANCOMYCIN HYDROCHLORIDE

Available from:

Generics (UK) Limited

ATC code:

J01XA01

INN (International Name):

VANCOMYCIN HYDROCHLORIDE

Dosage:

1000 Milligram

Pharmaceutical form:

Pdr/Conc/Soln for Infus

Administration route:

Intravenous infusion

Units in package:

Pack size of 1 vial

Prescription type:

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

Manufactured by:

Agila Specialties Polska

Therapeutic group:

Antibacterials for systemic use: Glycopeptide antibacterials

Therapeutic area:

vancomycin

Therapeutic indications:

It is used for severe infections, caused by gram-positive bacteria susceptible to vancomycin which cannot be treated with or failed to respond or are resistant to other antibiotics such as penicillins and cephalosporins.

Authorization status:

Not Marketed

Authorization date:

2013-05-03

Patient Information leaflet

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
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.
-
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 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.
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 blood linked to the infections listed above.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VANCOMYCIN
DO NOT USE VANCOMYCIN
-
if you are allergic to vancomycin or any of the other ingredients of
this medicine (listed in section
6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or hospital pharmacist or nurse before using
Vancomycin if:
-
You suffered a previous allergic reaction to teicoplanin because this
could mean you are also
allergic to vancomycin.
-
You have a hearing disorder, especially if you ar

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vancomycin 1000mg powder for concentrate for solution for infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains vancomycin hydrochloride corresponding to 1000 mg
vancomycin (equivalent to not less
than 1 050 000 IU).
When reconstituted with 20ml of water for injections, the resulting
concentrate for solution for infusion contains
50mg/ml vancomycin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White or off white powder.
Reconstituted concentrate for solution for infusion has a pH of
2.5 – 4.5.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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
- 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.
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.
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