Colistimethate 1million unit powder for solution for injection vials

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Colistimethate sodium

Inapatikana kutoka:

Kent Pharma (UK) Ltd

ATC kanuni:

J01XB01

INN (Jina la Kimataifa):

Colistimethate sodium

Kipimo:

1000000unit

Dawa fomu:

Powder for solution for injection

Njia ya uendeshaji:

Intravenous

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 05010700; GTIN: 5060061160117

Taarifa za kipeperushi

PATIENT INFORMATION LEAFLET
COLISTIMETHATE
SODIUM
1
MILLION
I.U.
POWDER
FOR
SOLUTION
FOR
INJECTION
1 MILLION INTERNATIONAL UNITS/VIAL
THE NAME OF YOUR MEDICINE IS Colistimethate
sodium 1 Million I.U. Powder for Solution for
Injection.
It is referred to as Colistimethate in this leaflet.
•
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 if you
notice any side effects not listed in this leaflet,
please tell the doctor, nurse or pharmacist.
IN THIS LEAFLET:
1. What Colistimethate is and what it is used for
2. What you need to know before you are given
Colistimethate
3. How Colistimethate is given
4. Possible side-effects
5. Storing Colistimethate
6. Further information
1.
W
HAT
C
OLISTIMETHATE IS AND WHAT IT IS USED FOR
Colistimethate is given by injection to treat some
types of serious infections caused by certain
bacteria. Colistimethate is used when other
antibiotics are not suitable.
2.
W
HAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
C
OLISTIMETHATE
Colistimethate is not suitable for everyone. Some
people MUST NOT have this injection. Do not have the
injection:
If you are allergic (hypersensitive) to colistimethate,
colistin or to other polymyxins.
If you are unsure about anything, ask your doctor
before you have the injection.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before
using Colistimethate
- If you have or have had kidney problems.
- If you suffer from myasthenia gravis
- If you suffer from porphyria
In premature and new-born babies, special care
should be taken when using Colistimethate as the
kidneys are not yet fully developed.
OTHER MEDICINES AND COLISTIMETHATE
- medicines which can affect how your kidneys
function. Taking such medicines at the same time as
Colistimethate can increase the risk of damage to
the kidneys
- medicines which can affect your nervous system.
Taking such medicines at the same time as
Colistimethate can increase the risk of side

Tabia za bidhaa

OBJECT 1
COLISTIMETHATE SODIUM 1 MILLION I.U. POWDER FOR
SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 12-Jun-2018 | Beacon
Pharmaceuticals
1. Name of the medicinal product
Colistimethate Sodium 1 Million I.U. Powder for Solution for Injection
2. Qualitative and quantitative composition
Colistimethate Sodium 1 Million I.U. (International Units)
3. Pharmaceutical form
Powder for Solution for Injection
White lyophilised powder in a glass vial.
4. Clinical particulars
4.1 Therapeutic indications
Colistimethate Sodium 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 9MIU/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 normal and impaired renal
functions including those on renal