Vancomycin Actavis 1000 mg Pulver till koncentrat till infusionsvätska, lösning

Země: Švédsko

Jazyk: švédština

Zdroj: Läkemedelsverket (Medical Products Agency)

Aktivní složka:

vankomycinhydroklorid

Dostupné s:

Actavis Group PTC ehf.

ATC kód:

J01XA01

INN (Mezinárodní Name):

vancomycin HCl

Dávkování:

1000 mg

Léková forma:

Pulver till koncentrat till infusionsvätska, lösning

Složení:

vankomycinhydroklorid 1025,32 mg Aktiv substans

Třída:

Apotek

Druh předpisu:

Receptbelagt

Terapeutické oblasti:

Vankomycin

Přehled produktů:

Förpacknings: Injektionsflaska, 1000 mg

Stav Autorizace:

Avregistrerad

Datum autorizace:

2015-02-12

Informace pro uživatele

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
VANCOMYCIN ACTAVIS 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
VANCOMYCIN ACTAVIS 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, pharmacist 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, 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 Actavis is and what it is used for
2.
What you need to know before you use Vancomycin Actavis
3.
How to use Vancomycin Actavis
4.
Possible side effects
5.
How to store Vancomycin Actavis
6.
Contents of the pack and other information
1.
WHAT VANCOMYCIN ACTAVIS IS AND WHAT IT IS USED FOR
HOW DOES THE MEDICINE WORK?
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.
WHAT IS THE MEDICINE USED FOR?
Vancomycin Actavis 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VANCOMYCIN ACTAVIS
DO NOT USE VANCOMYCIN ACTAVIS
-
If you are allergic to vancomycin.
WARNINGS AND PRECAUTIONS
Serious side effects that may lead to loss of vision have been
reported following the injection of
vancom

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Vancomycin Actavis 1000 mg powder for concentrate for solution for
infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1000 mg vancomycin hydrochloride equivalent to
1,000,000 IU vancomycin
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion
A white to cream coloured porous cake
After reconstitution a solution is obtained with a pH of approximately
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Intravenous administration
Vancomycin Actavis 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 Actavis 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 dose of 25-30 mg/kg of body
weight can be used to facilitate rapid
attainment of target trough serum vancomycin concentration.
Infants and children aged from one month to less than 12 years of age
The recommend