PROMIXIN 1 million International Unit Powder for nebuliser solution
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
19-07-2017
Summary of Product characteristics
(SPC)
13-02-2016
Active ingredient:
COLISTIN MESILATE SODIUM
Available from:
Profile Pharma Limited
ATC code:
J01XB01
INN (International Name):
COLISTIN MESILATE SODIUM
Dosage:
1 million International Unit
Pharmaceutical form:
Powder for nebuliser solution
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Polymixins
Authorization status:
Authorised
Authorization date:
2004-10-29
Patient Information leaflet
Promixin 1 million International Units (IU) Powder for Nebuliser
Solution
Article 61(3) notification February 2017 – UK and Ireland - Approved
-1-
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROMIXIN
1 MILLION INTERNATIONAL UNITS (IU)
POWDER FOR NEBULISER SOLUTION
colistimethate sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor, nurse,
physiotherapist or
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
If any of the side effects get serious, or you notice any side effects
not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET
1.
What Promixin is and what it is used for
2.
What you need to know before you take Promixin
3.
How to take Promixin
4.
Possible side effects
5.
How to store Promixin
6.
Contents of the pack and other information
1.
WHAT PROMIXIN IS AND WHAT IT IS USED FOR
Promixin contains colistimethate sodium, and is given as an inhalation
to treat chronic chest
infections in patients with cystic fibrosis. Promixin is used when
these infections are caused
by specific bacteria called _Pseudomonas aeruginosa_._ _
This_ _is a very common bacteria that infects the lungs of nearly all
patients with cystic fibrosis
at some time during their lives. If the infection is not properly
controlled it will continue to
damage the lungs, causing further problems.
Promixin is dissolved in sterile saline (salt water) or sterile water
and then breathed (inhaled)
into the lungs so that more of the antibiotic can target the bacteria
causing the infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROMIXIN
In certain circumstances your doctor may decide not to prescribe
Promixin.
DO NOT USE PROMIXIN AND TELL YOUR DOCTOR IF:
you are ALLERGIC (hypersensitive) to colistimethate sodium, colistin
or other polymyxins;
IF THIS APPLIES TO YOU, SEE YOUR DOCTOR
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Promixin, 1 million International Units (IU), Powder for Nebuliser Solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 million International Units (IU) which is approximately equivalent to 80 mg of Colistimethate
Sodium.
3 PHARMACEUTICAL FORM
Powder for nebuliser solution. The powder is white to off-white.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Promixin is indicated for the management 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
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 MIU two to three times per day (max 6 MIU/day)
_Children < 2 years_
0.5-1 MIU twice daily (max 2 MIU/ day)
Relevant clinical guidance on treatment regimens, including duration of treatment, periodicity and co-administration of
other antibacterial agents should be adhered to.
_Older people_
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_
Dose adjustment is not considered necessary.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_
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