Promixin 1million unit powder for solution for injection 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 solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010700; GTIN: 5060045110039

Patient Information leaflet

Page 1 of 5
Promixin 1 million International Units Powder for Solution for
Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROMIXIN
1 MILLION INTERNATIONAL UNITS (IU)
POWDER FOR SOLUTION FOR INFUSION
colistimethate sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, nurse or
pharmacist.
•
If any of the side effects gets serious, or you notice any side
effects not listed in this leaflet,
please tell your doctor, nurse or pharmacist.
IN THIS LEAFLET
1.
What Promixin is and what it is used for
2.
Before you are given Promixin
3.
How you will be given Promixin
4.
Possible side effects
5.
How to store Promixin
6.
Further information
1.
WHAT PROMIXIN IS AND WHAT IT IS USED FOR
Promixin contains colistimethate sodium. It is an ANTIBIOTIC that is
given by injection to treat
some types of serious infections caused by certain bacteria.
Promixin is used when other antibiotics are not suitable.
2.
BEFORE YOU ARE GIVEN PROMIXIN
In certain circumstances your doctor may decide not to prescribe
Promixin.
DO NOT HAVE PROMIXIN AND TELL YOUR DOCTOR IF:
•
you are ALLERGIC (hypersensitive) to colistimethate sodium, colistin
or to other polymyxins;
IF THIS APPLIES TO YOU, TELL YOUR DOCTOR BEFORE YOU ARE GIVEN
PROMIXIN.
TAKE SPECIAL CARE WITH PROMIXIN AND TELL YOUR DOCTOR, PHARMACIST OR
NURSE IF:
•
you have or have had KIDNEY PROBLEMS;
•
you suffer from MYASTHENIA GRAVIS (a rare disease where your muscles
are extremely weak
and get tired very quickly);
•
you suffer from PORPHYRIA (a rare metabolic disease that some people
are born with).
In premature and new-born babies, special care should be taken when
using Promixin as the
kidneys are not yet fully developed.
TAKING OTHER MEDICINES
Please tell your doctor or pharmacist if you are taking or have
recently taken any other
medicines, including non-prescription medicines. THESE MEDICINES MAY
INTERFERE WITH THE
EFFECTS OF PROMIXIN.
Page 2 o

Summary of Product characteristics

OBJECT 1
PROMIXIN, 1 MILLION INTERNATIONAL UNITS (IU),
POWDER FOR SOLUTION FOR INFUSION
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 Solution for
Infusion
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 solution for infusion
The powder is white to off white
4. Clinical particulars
4.1 Therapeutic indications
Promixin 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).
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 MIU/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 required in patients with
good renal function in some cases. Clinical experience with such doses
is however extremely limited and
safety has not been established.
The loading dose applies to patients with