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:

Hikma Farmacêutica (Portugal) S.A.

ATC koda:

J01XA; J01XA01

INN (International ime):

VANCOMYCIN HYDROCHLORIDE

Doziranje:

500 milligram(s)

Farmaceutski oblik:

Powder for concentrate for solution for infusion

Tip recepta:

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

Područje terapije:

Glycopeptide antibacterials; vancomycin

Status autorizacije:

Not marketed

Datum autorizacije:

2013-01-04

Uputa o lijeku

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
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.
WHAT IS IN THIS LEAFLET:
1.
What Vancomycin is and what it is used for
2.
What you need to know before you useVancomycin
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
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).
WARNING AND PRECAUTIONS
Serious side effects that may lead to loss of vision have been
reported following the injection of
vancomycin in the eyes.
Talk to your doctor or hospital pharmacist or nurse before using
Vancomycin if:
-

Svojstava lijeka

Health Products Regulatory Authority
22 March 2024
CRN00F71V
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
Each vial contains:
500 mg vancomycin hydrochloride equivalent to 500,000 IU vancomycin.
When reconstituted with 10 ml of water for injections, the resulting
concentrate for solution for infusion contains 50 mg/ml
vancomycin.
For the full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Homogeneous, white to off-white freeze-dried powder.
Reconstituted solution pH is 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
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 do