Colomycin Pdr for Soln Inj/Inf 1000000IU

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

COLISTIN MESILATE, SODIUM

Available from:

Teva B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

ATC code:

J01XB01

INN (International Name):

COLISTIN MESILATE SODIUM 1000000 IU

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INFUSION OR INJECTION

Composition:

COLISTIN MESILATE SODIUM 1000000 IU

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2006-12-20

Patient Information leaflet

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.
• 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. This includes any possible side
effects not listed in this leaflet.
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.
PACKAGE LEAFLET:
INFORMATION FOR THE USER
COLOMYCIN INJECTION
1 MILLION OR 2 MILLION INTERNATIONAL UNITS
Powder for solution for injection,
infusion or inhalation
Colistimethate Sodium
• If you suffer from myasthenia gravis
• If you suffer from porphyria
• If you suffer from asthma
Some people may experience a feeling of
tightness in the chest due to narrowing of the
airways when inhaling Colomycin. Yo

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
COLOMYCIN INJECTION 1 million or 2 million International Units.
Powder for solution for injection, infusion or inhalation.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains either 1 million or 2 million International Units
Colistimethate
Sodium.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection, infusion or inhalation.
1 million IU/vial:
Sterile white powder in a 10ml colourless glass vial with a red
‘flip-off’ cap.
2 million IU/vial:
Sterile white powder in a 10ml colourless glass vial with a lilac
‘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
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 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.
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