Colistimethate Sodium 2 Million IU Powder for Solution for Injection

Country: Малта

Језик: Енглески

Извор: Medicines Authority

Активни састојак:

COLISTIMETHATE SODIUM

Доступно од:

Accord Healthcare Limited

АТЦ код:

J01XB01

INN (Међународно име):

COLISTIMETHATE SODIUM

Фармацеутски облик:

POWDER FOR SOLUTION FOR INJECTION

Састав:

COLISTIMETHATE SODIUM 2 million IU

Тип рецептора:

POM

Терапеутска област:

ANTIBACTERIALS FOR SYSTEMIC USE

Статус ауторизације:

Authorised

Информативни летак

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PACKAGE LEAFLET: INFORMATION FOR THE USER
COLISTIMETHATE SODIUM 2 MILLION I.U. POWDER FOR SOLUTION FOR INJECTION
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, pharmacist or
nurse.
-
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 Colistimethate sodium is and what it is used for
2.
What you need to know before you take Colistimethate sodium
3.
How to take Colistimethate sodium
4.
Possible side effects
5.
How to store Colistimethate sodium
6.
Contents of the pack and other information
1. WHAT COLISTIMETHATE SODIUM IS AND WHAT IT IS USED FOR
This medicinal product is an antibiotic belonging to the group of
polymyxins.
Colistimethate sodium is given by injection to treat some types of
serious infections caused by certain
bacteria. Colistimethate sodium is used when other antibiotics are not
suitable.
Colistimethate sodium is given as an inhalation to treat chronic chest
infections in patients with cystic
fibrosis. Colistimethate sodium is used when these infections are
cause by specific bacteria called
_Pseudomonas aeruginosa_
.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COLISTIMETHATE SODIUM
DO NOT USE COLISTIMETHATE SODIUM
-
if you are allergic
(hypersensitive) to colistimethate sodium, colistin or to other
polymyxins
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using colistimethate
sodium
- If you have or have had kidney problems.
- If you suffer from myasthenia gravis
- If you suffer from porphyria
- If you suffer from asthma (in inhaled route)
In premature and new-born babies, special care should be taken when
using colistimethate sodium as the
kidneys are not yet fully developed.
OTHER MEDICINES AND COLISTIMETHATE SODIUM
- medicines which can affect how your kidneys funct

Карактеристике производа

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1. NAME OF THE MEDICINAL PRODUCT
Colistimethate Sodium 1 Million I.U. Powder for Solution for Injection
Colistimethate Sodium 2 Million I.U. Powder for Solution for Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Colistimethate Sodium 1 million IU:
Each vial contains 1 million international units (IU) which is
approximately equivalent to 80 mg
colistimethate sodium (INN).
Colistimethate Sodium 2 millione IU:
Each vial contains 2 million international units (IU) which is
approximately equivalent to 160 mg
colistimethate sodium (INN).
3. PHARMACEUTICAL FORM
Powder for solution for injection
White to off-white powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Intravenous use:
Colistimethate Sodium is indicated in adults and children, including
neonates, for the treatment of serious
infections due to selected aerobic Gram-negative pathogens in patients
with limited treatment options (see
sections 4.2, 4.4, 4.8 and 5.1).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.

Inhalation use:
Colistimethate Sodium is indicated for the managment in adult and
paediatric of chronic pulmonary
infections due to
_Pseudomonas aeruginosa_
in patients with cystic fibrosis (see section 5.1).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION

Intravenous administration:
The dose to be administred and the treatment duration should take into
account the severity of the infection
as well as the clinical response. Therapeutic guidelines should be
adhered to.
The dose is expressed in international units (IU) of colistimethate
sodium (CMS). A conversion table from
CMS in IU to mg of CMS , as well as to mg of colistin base activity
(CBA) is included at the end of this
section.
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Posology
The following dose recommendations are made based on limited
population-pharmacokinetic data in
critically ill patients (see section 4.4):
_Adults and adolescents_
Mainte