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KOLNEB 2 MIU. POWDER FOR NEBULISER SOLUTION

Active substance(s): COLISTIMETHATE SODIUM / COLISTIMETHATE SODIUM / COLISTIMETHATE SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Kolneb 2 MIU, Powder for Nebuliser Solution
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.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
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.
2.
3.
4.
5.
6.

What Kolneb 2 MIU is and what it is used for
What you need to know before you use Kolneb 2 MIU
How to use Kolneb 2 MIU
Possible side effects
How to store Kolneb 2 MIU
Contents of the pack and other information

1.

What Kolneb 2 MIU is and what it is used for

Kolneb 2 MIU is given as an inhalation to treat chronic chest infections in patients with cystic fibrosis.
Kolneb 2 MIU is used when these infections are cause by specific bacteria called Pseudomonas aeruginosa.

2.

What you need to know before you use Kolneb 2 MIU

Do not use Kolneb 2 MIU
If you are allergic (hypersensitive) to colistimethate sodium, colistin sulphate or to other polymyxins.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Kolneb 2 MIU
- If you have or have had kidney problems.
- If you suffer from myasthenia gravis
- If you suffer from porphyria
- If you suffer from asthma.
In premature and new-born babies, special care should be taken when using Kolneb 2 MIU as the kidney
are not yet fully developed.

Other medicines and Kolneb 2 MIU
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines,
including medicines you bought without a prescription. These medicines may interfere with the effect of
Kolneb 2 MIU
- medicines which can affect how your kidneys function. Taking such medicines at the same time as Kolneb
2 MIU can increase the risk of damage to the kidneys.
- medicines which can affect your nervous system. Taking such medicines at the same time as Kolneb 2
MIU can increase the risk of side effects in your nervous system

1

- medicines called muscle relaxants, often used during general anaesthesia. Kolneb 2 MIU can increase the
effects of these medicines. If you have a general anaesthetic, let your anaesthetist know that you are having
Kolneb 2 MIU
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 Kolneb 2 MIU further increases the risk of muscle weakness and
breathing difficulties.
Having Kolneb 2 MIU as an infusion at the same time as receiving Kolneb 2 MIU as an inhalation can
increase your risk of side effects.
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. Kolneb 2 MIU should only be given during
pregnancy or breast-feeding when clearly needed.
Driving and using machines
Kolneb 2 MIU may make you feel dizzy, confused or have problems with your sight, such as blurred vision.
If this happens to you, do not drive or operate any tools or machines and talk to your doctor or pharmacist.

3.

How to use Kolneb 2 MIU

Kolneb 2 MIU is for inhalation use.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Your doctor may decide to adjust the dose depending on your circumstances. If you also take other inhaled
medicines, your doctor will tell you which order to taken them in.
The recommended dose is:

Adults
Children
(age 2 years to 11 years)
and Adolescents
(age 12 years to 17 years)
Children younger
than 2 years

Recommended Dose

Maximum dose per day

1 to 2 Million International Units
(MIU) two to three times a day

6 MIU per day

1 to 2 Million International Units
(MIU) two or three times a day

6 MIU per day

0.5 to 1 Million International Units
(MIU) ) two times a day

2 MIU per day

Please note Kolneb 2 MIU is also available as 1 MIU vial.
You should take your first dose of Kolneb 2 MIU when you are with your doctor or nurse.
Take your Kolneb 2 MIU after physiotherapy (if you have physiotherapy).
Duration of treatment
Your doctor will tell you how long your treatment with Kolneb 2 MIU will last. Do not stop treatment early
because when treating bacterial infections it is important to complete the full course of treatment to reduce
the risk of resistance formation of the infectious bacteria.
2

Preparation for inhalation treatment
If you are treating yourself at home, your doctor or nurse will show you how to use Kolneb 2 MIU in your
nebuliser when you first start this treatment.
Before Kolneb 2 MIU can be used it must be dissolved in isotonic saline solution (salt water).
To start your treatment, you will need the following:


One clear-glass vial of Kolneb 2 MIU



The solvent for dissolving the powder (4 ml of isotonic saline solution)



A nebuliser appropriate for inhalation use of Kolneb 2 MIU (e.g. PARI LC PLUS, PARI
LC SPRINT or eFlow rapid)

It is important that your nebuliser system functions properly before starting your treatment with
Kolneb 2 MIU Read carefully the instructions for use of the nebuliser for further information on
handling the nebuliser system.
Place the components of your nebuliser on a clean flat surface and follow the manufacturer’s instructions for
use.
Preparing your Kolneb 2 MIU for inhalation
Kolneb 2 MIU must be used immediately after dissolution. Do not dissolve Kolneb 2 MIU until ready to
administer a dose (see also section 5).
Step 1: Take one vial of Kolneb 2 MIU and gently tap the glass vial so that the powder settles to the bottom.
This helps ensure you get the proper dose of medication. Open the drug vial by lifting up the plastic overcap
on the top (Figure 1).
Step 2: Pull down to carefully remove the entire plastic overcap together with metal ring from the vial
(Figure 2). Safely dispose of the ring and overcap.
Step 3: Carefully remove the rubber stopper (Figure 3). Add the solvent (4 ml of isotonic saline solution)
to the corresponding vial to dissolve the powder:
In order to avoid foaming, shake the vial gently until all powder is dissolved. Pour the solution into the
nebuliser. Do not use Kolneb 2 MIU if you notice visible particles in the solution after dissolution.
Once prepared Kolneb 2 MIU should be used immediately. Any unused solution should be disposed of.

3

Using your Kolneb 2 MIU
Kolneb 2 MIU is for inhalation use with an appropriate nebuliser (e.g. PARI LC PLUS, PARI LC SPRINT
or eFlow rapid).
For more detailed information on correct use of the selected nebuliser follow the instruction manual of the
nebuliser.
Inhalation should take place in a well ventilated room.
After inhalation of Kolneb 2 MIU
Please refer to the manufacturer’s instructions for use of the nebuliser for cleaning and disinfecting
instructions.
If you use more Kolneb 2 MIU than you should
If you realise that you have used more Kolneb 2 MIU than your doctor has recommended (or if someone
else has used some of your Kolneb 2 MIU), contact your doctor or pharmacist straight away.
The symptoms of taking too much Kolneb 2 MIU can include:








tingling or numbness around the lips and face
dizziness and spinning sensation (vertigo)
slurred speech
visual disturbance
confusion
mental disturbance
flushing (reddening of the face)

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
If you forget to use Kolneb 2 MIU
Take the dose as soon as you remember, unless it is near the time for your next dose. You do not need to
make up for the dose you have missed.
If you stop using Kolneb 2 MIU
Do not stop your treatment early unless your doctor says that you can. Your doctor will tell you how long
your treatment will last.
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.
Kolneb 2 MIU can sometimes cause allergic reactions like skin rash. If this happens you should stop
taking Kolneb 2 MIU and tell your doctor immediately.
Breathing in Kolneb 2 MIU through a nebuliser can make some people notice tightness in their chest, feel
wheezy, cough or become breathless. For this reason the first dose should be taken when you are with your
doctor or nurse. Your doctor may also advise you to take a medicine to help prevent any breathlessness.
Your doctor may check your breathing at your clinic visits.
Kolneb 2 MIU might also affect your kidneys, usually if the dose is high or you are taking other medicines
that may affect your kidneys.
Kolneb 2 MIU may sometimes cause you to have a sore mouth or sore throat.

4

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 side effects directly via the Yellow Card Scheme (Website:
www.mhra.gov.uk/yellowcard ). By reporting side effects you can help provide more information on the
safety of this medicine.

5.

How to store Kolneb 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 carton and on the vial label after EXP.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the vials in the outer carton.
Kolneb 2 MIU, Powder for nebuliser solution should be used immediately after preparation.
Any remaining solution should be discarded.
For single use only.
Do not throw away any medicines via wastewater or household waste. 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 Kolneb 2 MIU contains
-

-

The active substance is colistimethate sodium (also known as colistin).
Each vial contains 2 million International Units (IU) of colistimethate sodium, which weighs about
160 milligrams (mg).
There are no other ingredients.

What Kolneb 2 MIU looks like and contents of the pack
Kolneb 2 MIU is a powder for nebuliser solution after reconstitution with an adequate volume of solvent.
2 MIU/vial: White to off-white powder in a 10 ml colourless glass vial with a lilac cap.
Also available:
1 MIU/vial: White to off-white powder in a 10 ml colourless glass vial with a red cap.
The product is available in the following pack sizes:
• 1 vial
• 2 vials
• 10 vials
• 14 vials
• 28 vials
• 56 vials
Not all pack sizes may be marketed.
5

Marketing Authorisation Holder
Forest Pharma B.V.
Newtonlaan 115
3584 BH, Utrecht
Netherlands
Manufacturers
Forest Tosara Ltd.
Unit 146 Baldoyle Industrial Estate
Baldoyle, Dublin 13
Ireland
Teva Pharmaceuticals Europe B.V.
Swensweg 5
Haarlem
2031 GA
The Netherlands

This medicinal product is authorised in the Member States of the EEA under the following names:
Austria

Kolneb 2 Mio. I.E. Pulver zur Herstellung einer Lösung für einen Vernebler

Belgium

Kolneb 2 million UI/2 miljoen Internationale Eenheden (IE)/2 Million IE, poudre
pour solution pour inhalation par nébuliseur/ poeder voor oplossing voor
verneveling/ Pulver zur Herstellung einer Lösung für einen Vernebler

Finland

Colineb 2 miljoona KY, jauhe sumutinliuosta varten

Germany

Colistineb 2 Million I.E. Pulver zur Herstellung einer Lösung für einen Vernebler

The Netherlands

Kolneb, 2 miljoen Internationale Eenheden (IE), poeder voor verneveloplossing

Norway

Colineb 2 MIU pulver til inhalasjonsvæske til nebulisator, oppløsning

Spain

Colistimetato de sodio YES 2 millones de UI, polvo para solución para inhalación
por nebulizador

Sweden

Colineb 2 miljon IE, pulver till lösning för nebulisator

This leaflet was last revised in March 2017.

6

Expand Transcript

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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