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KOLJECT 2 MIU POWDER FOR SOLUTION FOR INFUSION

Active substance(s): COLISTIMETHATE SODIUM

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Package leaflet: Information for the user
Kolject 2 MIU, Powder for solution for infusion
Colistimethate sodium
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, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.
What Kolject 2 MIU is and what it is used for
2.
What you need to know before you use Kolject 2 MIU
3.
How to use Kolject 2 MIU
4.
Possible side effects
5.
How to store Kolject 2 MIU
6.
Contents of the pack and other information
1.

What Kolject 2 MIU is and what it is used for

Kolject 2 MIU contains the active substance colistimethate sodium. Colistimethate sodium is an
antibiotic. It belongs to a group of antibiotics called polymixins.
Kolject 2 MIU is given by injection to treat some types of serious infections caused by certain
bacteria. Kolject 2 MIU is used when other antibiotics are not suitable.
2.

What you need to know before you use Kolject 2 MIU

Do not use Kolject 2MIU
- If you are allergic (hypersensitive) to colistimethate sodium, colistin or to other polymyxins.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Kolject 2MIU
- 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 Kolject 2MIU as the
kidneys are not yet fully developed.
Other medicines and Kolject 2 MIU
You must tell your doctor if you are taking any of the following medicines:
- medicines like antibiotics called aminoglycosides (which include gentamicin, tobramycin, amikacin,
and netilmicin) and cephalosporins which can affect how your kidneys function. Taking such
medicines at the same time as Kolject 2MIU can increase the risk of damage to the kidneys

- medicines like antibiotics called aminoglycosides (which include gentamicin, tobramycin, amikacin,
and netilmicin) and cephalosporins which can affect your nervous system. Taking such medicines at
the same time as Kolject 2 MIU can increase the risk of side effects in the ears and other parts of your
nervous system
- medicines called muscle relaxants, often used during general anaesthesia. Kolject 2MIU can increase
the effects of these medicines. If you have a general anaesthetic, let your anaesthetist know that you
are having Kolject 2MIU
If you suffer from myasthenia gravis and are also taking other antibiotics called macrolides (such as
azithromycin, clarithromycin or erythromycin) or antibiotics called fluoroquinolones (such as
ofloxacin, norfloxacin and ciprofloxacin), taking Kolject 2 MIU further increases the risk of muscle
weakness and breathing difficulties.
Having Kolject 2MIU as an infusion at the same time as receiving Kolject 2MIU as an inhalation can
increase your risk of side effects.
Make sure the doctor knows about any other medicines that you are taking, including medicines that
you obtained without a prescription.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Some people have reported side effects such as dizziness, confusion or problems with vision.
If you are affected do not drive or operate machines and talk to your doctor or pharmacist.
Kolject 2 MIU contains sodium
This medicinal product contains less than 1mmol sodium (23mg) per vial, i.e. essentially ‘sodiumfree’.
3.

How to use Kolject 2 MIU

Kolject 2MIU is given to you by your doctor as a slow injection (infusion into a vein over 30 – 60
minutes) or as a fast injection (over 5 minutes into a special kind of tube in a vein). Kolject 2 MIU
may occasionally be given by injection into the heart or the spine.
The usual daily dose in adults is 9 million units, divided into two or three doses. If you are quite
unwell, you will be given a higher dose of 9 million units once at the start of treatment.
In some cases, your doctor may decide to give a higher daily dose of up to 12 million units.
The usual daily dose in children weighing up to 40 kg is 75.000 to 150.000 units per kilogram body
weight, divided into three doses.
Higher doses have occasionally been given in cystic fibrosis.
Children and adults with kidney problems, including those on dialysis, are usually given lower doses.
Your doctor will monitor your kidney function regularly while you receive Kolject 2MIU.
Your doctor will decide how long your treatment should last depending of the severity of the
infection. When treating bacterial infections it is important to complete the full course of treatment.

If you are given too much Kolject 2 MIU than you should
As a doctor or nurse will be giving you Kolject 2 MIU, it is unlikely that you will receive an incorrect
dose. Tell your doctor or nurse if you have any concerns about the amount of medication that you are
given.
The symptoms of having too much Kolject 2 MIU can include:

dizziness and spinning sensation (vertigo)

slurred speech

visual disturbance

confusion

mental disturbance

tingling or numbness of the face

kidney problems

muscle weakness

feeling as though you cannot breathe
If you think that you may have missed a dose, please speak to your doctor or nurse.
Stopping Kolject 2 MIU
Your doctor will decide how long you should be given Kolject 2 MIU. It is important that your
treatment is completed as advised by your doctor or your symptoms may get worse.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some side
effects can be serious.
Tell the doctor or nurse immediately if you notice any of the following symptoms:

Wheezing or breathing difficulties which can lead to collapse, a rash, itching or hives on the skin,
or sudden swelling of the face, throat or lips. These can be signs of a severe allergic reaction.
Kolject 2 MIU can also affect your kidneys, especially if the dose is high or you are taking other
medicines that may affect your kidneys.
Very common side effects (affecting more than 1 person in 10)

blood tests may show changes in the way the kidneys are working

headache

tingling or numbness around the mouth, lips and face

itching

muscle weakness
Rare side effects (affecting less than 1 person in 1 000)

kidney failure
Other side effects can include:

dizziness

difficulty in controlling movements

soreness at the site of injection
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report any side effects directly to the national reporting system
via the internet at www.mhra.gov.uk/yellowcard; or you can report via the Yellow Card Scheme. By
reporting side effects you can help provide more information on the safety of this medicine.
5.

How to store Kolject 2 MIU

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer carton and the vials after
EXP. The expiry date refers to the last day of that month.
Do not freeze.
Store below 25°C.
Keep the vial(s) in the outer carton, in order to protect from light.
Reconstituted/diluted solution should be used immediately after preparation. If this is not possible, talk
first to your doctor or pharmacist as the solutions may bestored in the refrigerator (2 to 8oC)for no
longer than 24 hours.
For single use only. Discard any unused solution.
Do not use this medicine if you notice any discoloration or cloudiness of the solution.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines
you no longer use. These measures will help protect the environment.
6.

Contents of the pack and other information

What Kolject 2 MIU contains
The active substance is colistimethate sodium. There are no other ingredients.
What Kolject 2 MIU looks like and contents of the pack
Kolject 2 MIU is a creamy white powder for injection or infusion in single dose 10ml vials. Each type
I glass vial contains the active ingredient, colistimethate sodium (also called colistin) as an amount of
powder equivalent to two million international units,
with lilac ‘flip-off’ cap , supplied as pack sizes of:
• 1 vial
• 10 vials
• 30 vials
• 60 vials
• 100 vials
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Forest Pharma B.V.
Newtonlaan 115
3584 BH, Utrecht
Netherlands
Manufacturer

Forest Tosara Ltd.
Unit 146 Baldoyle Industrial Estate
Baldoyle, Dublin 13
Ireland
This medicinal product is authorised in the Member States of the EEA under the following
names:
Austria
Belgium

Germany
The Netherlands

Colintens 2 Mio. I.E. Pulver zur Herstellung einer Infusionslösung
Colistiject 2 Millionen I.E./Colistiject 2 million UI/Colistiject 2
miljoen Internationale Eenheden (I.E.), Pulver zur Herstellung einer
Infusionslösung/Poudre pour solution pour perfusion/Poeder voor
oplossing voor infusie
Colist-Infusion 2 Millionen I.E. Pulver zur Herstellung einer
Infusionslösung
Kolject, 2 miljoen Internationale Eenheden (IE) poeder voor oplossing
voor infusie

This leaflet was last revised in 09/2015.
If you find this leaflet difficult to read or understand, please speak to the doctor or nurse or contact the
marketing authorisation holder at the above address.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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