COLOMYCIN 1 million International Units (IU) Powder for solution for injection, infusion or inhalation

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Colistimethate sodium

Tilgjengelig fra:

Teva B.V.

ATC-kode:

J01XB; J01XB01

INN (International Name):

Colistimethate sodium

Dosering :

1 million international units

Legemiddelform:

Powder for solution for injection/infusion

Resept typen:

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

Terapeutisk område:

Polymyxins; colistin

Autorisasjon status:

Marketed

Autorisasjon dato:

2005-06-07

Informasjon til brukeren

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
COLOMYCIN 1 MILLION OR 2 MILLION INTERNATIONAL UNITS (IU)
POWDER FOR SOLUTION FOR INJECTION, INFUSION OR INHALATION
colistimethate sodium
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.
•
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 Colomycin is and what it is used for
2.
What you need to know before you use Colomycin
3.
How to use Colomycin
4.
Possible side effects
5.
How to store Colomycin
6.
Contents of the pack and other information
1.
WHAT COLOMYCIN IS AND WHAT IT IS USED FOR
Colomycin contains the active substance colistimethate sodium.
Colistimethate sodium is an
antibiotic. It belongs to a group of antibiotics that are called
polymyxins.
Colomycin is given by injection to treat some types of serious
infections caused by certain bacteria.
Colomycin is used when other antibiotics are not suitable.
Colomycin is given as an inhalation to treat chronic chest infections
in patients with cystic fibrosis.
Colomycin is used when these infections are caused by specific
bacteria called
_Pseudomonas _
_aeruginosa. _
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE COLOMYCIN
DO NOT USE COLOMYCIN
- 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 Colomycin
- If you have or have had kidney problems.
- If you suffer from myasthenia gravis
- If you suffer from porphyria
- If you suffer from asthma
If you experience muscle spasm, fatigue or increased urine output

Preparatomtale

Health Products Regulatory Authority
17 July 2023
CRN00DM3J
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
COLOMYCIN 1 million International Units (IU) Powder for solution for
injection, infusion or inhalation
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 million IU Colistimethate Sodium.
3 PHARMACEUTICAL FORM
Powder for solution for injection, infusion or inhalation.
Sterile white powder in a 10ml colourless glass vial with a red
‘flip-off’ cap.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Colomycin by intravenous administration 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).
Colomycin by inhalation is also indicated for the management of adult
and paediatric 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
SYSTEMIC TREATMENT
The dose to be administered 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 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.
Posology
The following dose recommendations are made based on limited
population-pharmacokinetic data in critically ill patients (see
section 4.4):
_Adults and adolescents _
Maintenance dose 9 million IU/day in 2-3 divided doses
In patients who are critically ill, a loading dose of 9 MIU should be
administered.
The most appropriate time interval to the first maintenance dose has
not been established.
Modelling suggests that loading and maintenance doses of up to 12 MIU
may be req