Colistimethate sodium 1 million IU Powder for nebuliser solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Colistimethate sodium

Available from:

Noridem Enterprises Limited

ATC code:

J01XB01

INN (International Name):

Colistimethate sodium

Pharmaceutical form:

Powder for nebuliser solution

Therapeutic area:

colistin

Authorization status:

Not marketed

Authorization date:

2023-02-17

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
COLISTIMETHATE SODIUM 1 MILLION IU POWDER FOR NEBULISER SOLUTION
COLISTIMETHATE SODIUM_ _2 MILLION IU POWDER FOR NEBULISER SOLUTION
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 or pharmacist.
-
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. 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 use Colistimethate sodium
3.
How to use 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 medicine
_ _
contains the active substance colistimethate sodium. Colistimethate
sodium is an
antibiotic. It belongs to a group of antibiotics that are called
polymyxins.
This medicine
_ _
is given as an inhalation to treat chronic chest infections in
patients with cystic
fibrosis. Colistimethate sodium is used when these infections are
caused by specific bacteria called
_Pseudomonas aeruginosa. _
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE COLISTIMETHATE SODIUM
DO NOT USE COLISTIMETHATE SODIUM
-
If you are allergic 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
- you suffer from myasthenia gravis (disease characterized by muscle
weakness)
- you suffer from porphyria
- you suffer from asthma
Some people may experience a feeling of tightness in the chest due to
narrowing of the airways when

Summary of Product characteristics

Health Products Regulatory Authority
04 July 2023
CRN00DLNK
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Colistimethate sodium 1 million IU Powder for nebuliser solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 million IU colistimethate sodium.
3 PHARMACEUTICAL FORM
Powder for nebuliser solution.
White to off-white powder.
pH of 1 vial Colistimethate sodium 1 million IU powder in 3 ml: 6.5 -
8.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Colistimethate sodium by inhalation is 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
It is recommended that colistimethate sodium (CMS) should be
administered under the supervision of physicians with
appropriate experience in its use.
Posology
The dosage can be adjusted depending on the severity of the condition
and clinical response.
Recommended dose range:
_ _
_Administration via inhalation_
_ _
_Adults, adolescents and children ≥ 2 years_
1-2 million IU two to three times per day (max 6 million IU/day)
_ _
_Children < 2 years_
0.5-1 million IU twice daily (max 2 million IU/ day)
Relevant clinical guidance on treatment regimens, including duration
of treatment, periodicity and co-administration of other
antibacterial agents should be adhered to.
Special populations
_ _
_Elderly_
Dose adjustment is not considered necessary.
_Renal impairment_
Dose adjustment is not considered necessary, however caution is
advised in patients with renal impairment (see sections 4.4
and 5.2).
_ _
_Hepatic impairment_
Health Products Regulatory Authority
04 July 2023
CRN00DLNK
Page 2 of 7
Dose adjustment is not considered necessary.
Method of administration
For inhalation use.
Suitable nebulisers are the reusable jet nebulisers including the PARI
LC PLUS or the PARI LC SPRINT,