Promixin 1million unit powder for nebuliser solution unit dose vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Colistimethate sodium

Available from:

Zambon UK Ltd

ATC code:

J01XB01

INN (International Name):

Colistimethate sodium

Dosage:

1000000unit

Pharmaceutical form:

Powder for nebuliser solution

Administration route:

Inhalation

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010700; GTIN: 5060045110022

Patient Information leaflet

Promixin 1 million International Units (IU) Powder for Nebuliser
Solution
-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 BEFORE YOU START TAKING
PROMIXIN.
TAKE SPECIAL CARE WITH PROMIXIN AND

Summary of Product characteristics

OBJECT 1
PROMIXIN 1 MILLION INTERNATIONAL UNITS (IU)
POWDER FOR NEBULISER SOLUTION
Summary of Product Characteristics Updated 04-Jun-2018 | Profile
Pharma Limited
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.
METHOD OF ADMINISTRATION
Promixin for nebulisation is intended for administration by
nebulisation using a suitable nebuliser.
Drug delivery characteristics from _in vitro_ studies with different
nebuliser systems are detailed below;