Colistimethate Sodium Pdr for Soln for Injection 1 million IU

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

COLISTIMETHATE SODIUM

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

J01XB01

INN (International Name):

COLISTIMETHATE SODIUM 1 million IU

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

COLISTIMETHATE SODIUM 1 million IU

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2017-06-05

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
COLISTIMETHATE SODIUM ACCORD 1 MILLION IU POWDER FOR SOLUTION FOR
INJECTION/INFUSION
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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET
1.
What Colistemathe sodiumis and what it is used for
2.
What you need to know before you take Colistemathe sodium
3.
How to take Colistemathe sodium
4.
Possible side effects
5.
How to store Colistemathe sodium
6.
Contents of the pack and other information
1. WHAT
Colistemathe sodium
IS AND WHAT IT IS USED FOR
Antibiotics are used to treat infections caused by bacteria. They have
no effect against infections caused by
viruses such as colds or the flu .
It is important to follow your doctor´s direction when taking the
medicine regarding dosage related
instructions, the doses and the duration of the treatment given by
your doctor.
Do not keep or reuse this medicinal product. If there is remaining
antibiotic, once you have finished the
treatment, return it to the pharmacy for proper disposal. Don’t
throw medicines down the drain or into the
rubbish.
Colistemathe sodium contains the active substance colistimethate
sodium. Colistimethate sodium is an
antibiotic belonging to the group called polymyxins. This medicine is
indicated in adults and childrenfor:
-
Intravenous use (IV). Colistemathe sodiumis given by injection to
treat some types of serious infections
caused by certain bacteria. Colistemathe sodiumis used when other
antibiotics are not suitable.
-
Inhalation use. Colistemathe sodiumis given as an inhalation to treat
chronic chest infections in patients
with cystic fibrosis. Colistemathe sodiumis used when these infections
are caused by specific bacteria
called
_Pseu

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Colistimethate Sodium Accord 1 million IU powder for solution for
injection/infusion,
Colistimethate Sodium Accord 2 million IU powder for solution for
injection/infusion,
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Colistimethate Sodium Accord 1 million IU:
Each vial contains 1 million international units (IU) which is
approximately equivalent to 80 mg
colistimethate sodium (INN).
Colistimethate Sodium Accord 2 million IU:
Each vial contains 2 million international units (IU) which is
approximately equivalent to 160 mg
colistimethate sodium (INN).
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for solution for injection/,infusion .
White to off-white powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Intravenous use:
Colistemathe 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
.
•
Inhalation use:
Colistemathe Sodium is indicated for the managment 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
•
Intravenous use:
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.
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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 followin