1 million IU, 2 million IU powder for solution for nebulizer 
colistimethate

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Colineb is and what it is used for 
2. What you need to know before using Colineb 
3. How to use Colineb 
4. Possible side effects 
5. How to store Colineb 6. Contents of the pack 
and other ingredients information 

1. What Colineb is and what it is used for

Colineb is given by inhalation to treat the chronic infection in the airways of patients with cystic fibrosis. Colin is used when these infections are caused by specific bacteria called Pseudomonas aeruginosa.

Colistimethate sodium found in Colineb may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Colineb

Do not use Colineb

  • if you are allergic (hypersensitive) to colistimethate sodium, colistin, or other polymyxins.

Warnings and cautions

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Colineb

  • if you have or have had kidney problems
  • if you suffer from myasthenia gravis
  • if you suffer from porphyria
  • if you suffer from asthma.

Children

In premature and newborns, special care should be taken when using Colineb as the kidneys are not fully developed.

Other drugs and Colineb

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The following medicines may interfere with the effect of Colineb:

  • drugs that can affect your kidney function. If you take Colineb at the same time as these medicines, the risk of kidney damage may increase.
  • drugs that can affect the nervous system. If you take Colineb at the same time as these medicines, the risk of side effects in the nervous system may increase.
  • drugs called muscle relaxants, which are often used under anesthesia. Colineb may increase the effect of these medicines. If you are going to be anesthetized, tell your anesthetist that you have taken Colineb.

If you suffer from myasthenia gravis and also use other antibiotics called macrolides(such as azithromycin, clarithromycin, or erythromycin) or antibiotics called fluoroquinolones (such as ofloxacin, norfloxacin, and ciprofloxacin ), while taking Colineb increases the risk of muscle weakness.

Taking colistimethate sodium as an infusion while inhaling Colineb may increase the risk of side effects.

Pregnancy and breastfeeding

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. Colineb should only be given during pregnancy or breast-feeding when really needed.

Driving and using machines

Colin can cause dizziness, confusion and visual disturbances, e.g. dimsyn.

If you get these side effects, do not drive or use any tools or machines. Talk to a doctor or pharmacist.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Colineb contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per bottle, ie essentially ‘sodium-free’.

3. How to use Colineb

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Your doctor may decide to adjust the dose depending on your circumstances. If you are also taking other inhaled medicines, your doctor will tell you the order in which you should take them.

The recommended dose is: Show larger


Recommended dose Maximum dose one per day
Adults 1 to 2 million international units (MIE) two to three times a day 6 MIE per day
Children(2 years to 11 years)and young people(12 years to 17 years) 1 to 2 million international units (MIE)two to three times a day 6 MIE per day
Children younger than 2 years 0.5 to 1 million international units (MIE)twice a day 2 MIE per day

You should take the first dose of Colineb in the presence of a doctor or nurse.

Take Colineb after breathing exercises (if you go to breathing exercises).

Length of treatment

Your doctor will tell you how long you should be treated with Colineb. Do not stop treatment prematurely. When treating the bacterial infection, it is important to complete the entire course of treatment to reduce the risk of developing resistance.

Method of administration

Colineb should be inhaled with a suitable nebulizer after the powder has dissolved.

Prepare inhalation treatment

If you are treating yourself at home, your doctor or nurse will show you how to use Colineb in the nebulizer when you first start treatment.

Before Colineb can be used, it must be dissolved in isotonic saline (saline). Show larger

To start treatment, you need the following:
a clear glass bottle with Colinebliquid to dissolve the powder (3 ml isotonic saline solution if you are to take Colineb 1 million IU, or 4 ml saline solution if you are going to take Colineb 2 million IU)a nebulizer, which is suitable for inhalation of Colineb (eg . PARI LC PLUS, PARI LC SPRINT or eFlow rapid)

It is important that the nebulizer system works properly before you start treatment with Colineb. Carefully read the nebulizer operating instructions for further information on handling the nebulizer system.

Lay the parts of the nebulizer on a clean, level surface and follow the manufacturer’s instructions.

Prepare Colineb for inhalation

Colineb must be used immediately after reconstitution. Do not dissolve Colineb until you are ready to inhale a dose (see also section 5).

Step 1: Take out a bottle of Colineb and tap the glass bottle gently so that the powder sinks to the bottom. This way you can check that you are getting the right dose of medicine. Open the medicine bottle by lifting the plastic cap (figure 1).

Step 2: Pull down to carefully remove the entire plastic cap along with the metal ring from the bottle (Figure 2). Dispose of the ring and lid securely.

Step 3: Carefully remove the rubber stopper (Figure 3).

Colineb 1 million IU: Add the liquid (3 ml isotonic saline solution) to the corresponding bottle to dissolve the powder.

Colineb 2 million IU: Add the liquid (4 ml isotonic saline solution) to the corresponding bottle to dissolve the powder.

Avoid foaming by gently shaking the bottle until all the powder has dissolved. Pour the solution into the nebulizer. Do not use Colineb if you notice particles in the solution after dissolution.

Colineb must be used immediately after reconstitution. All unused solution must be discarded.

Open

The contents of the bottle should be dissolved in an isotonic saline solution

Use Colineb

Colineb should be inhaled with a suitable nebulizer (eg PARI LC PLUS, PARI LC SPRINT, or eFlow rapid).

Read the instruction manual that came with the nebulizer for more information on using the selected nebulizer.

Inhalation should take place in a room with good ventilation.

After inhalation of Colineb 

See the nebulizer operating instructions for cleaning and disinfection instructions.

If you use more Colineb than you should

Symptoms of taking too much Colineb may include:

  • tingling or numbness around the lips and face
  • dizziness and tingling sensation ( vertigo )
  • slurred speech
  • visual disturbances
  • confusion
  • mental disorder
  • swelling ( redness of the face)

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

If you forget to use Colineb

Take one dose as soon as you remember, unless it is close to the next dose. You do not need to compensate for a missed dose.

If you stop taking Colineb

Do not stop treatment unless your doctor tells you to. The doctor will tell you how long the treatment should last.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Colineb can sometimes cause allergic reactions such as rash. If this happens to you, stop taking Colineb and tell your doctor immediately.

Some people may have difficulty breathing after inhaling Colineb through a nebulizer. For this reason, you should take the first dose in the presence of a doctor or nurse. Your doctor may also ask you to take a medicine that prevents shortness of breath. Your doctor may check your breathing during a visit to the clinic.

Colineb IE can also affect your kidneys, usually, if your dose is high or if you are taking other medicines that may affect your kidneys.

Other side effects:

Very common (affects more than 1 user in 10):

  • cough
  • the feeling of tightness in the chest
  • difficulty breathing
  • rustling breathing.

Has been reported (occurs in an unknown number of users):

  • sore throat
  • soreness in the mouth.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store Colineb

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 bottle label after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Reconstituted/diluted solution should be used immediately after reconstitution. If this is not possible, talk to your doctor or pharmacist. The solution can be stored refrigerated (2 ° C – 8 ° C) for a maximum of 24 hours, provided that the concentration is equal to or greater than 80,000 IU / ml.

For single use only. The remaining solution should be discarded.

Colineb powder for solution for nebulizer solution should be used immediately after preparation. Any remaining solution should be discarded.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is colistimethate sodium. Each bottle contains 1 million International Units (MIU) colistimethate sodium. Each bottle contains 2 million International Units (MIE) colistimethate sodium.
  • There are no other ingredients.

What the medicine looks like and the contents of the pack

Colineb is a powder for nebulizer solution after reconstitution with an appropriate volume of liquid.

Colineb 1 million IU: White to off-white powder in a 10 ml colorless glass bottle with a red cap.

Colineb 2 million IU: White to off-white powder in a 10 ml colorless glass bottle with a purple cap.

The product is available in the following pack sizes:

  • 1 bottle
  • 2 bottles
  • 10 bottles
  • 14 bottles
  • 28 bottles
  • 56 bottles

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Box 1070

251 10 Helsingborg

Manufacturer

Teva Pharmaceuticals Europe BV

Swensen 5

Haarlem

2031 GA

Netherlands

Millmount Healthcare Ltd.

Block 7, City North Business Campus

Stamullen

Co. Meath

K32 YD60

Ireland

Merckle GmbH

Ludwig-Merckle-Straβe 3

89143 Blaubeuren

Germany

Muhammad Nadeem

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