COLFINAIR

Package Leaflet: Information for the User

Colfinair 1 Million International Units, powder for solution for nebuliser

Colistimethate sodium
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Colfinair is and what it is used for

Colfinair is administered by inhalation for the treatment of chronic chest infections in patients with cystic fibrosis. Colfinair is used when these infections are caused by specific bacteria called Pseudomonas aeruginosa.

2. What you need to know before using Colfinair

Do not take Colfinair

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Colfinair

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

Particular care must be taken when using Colfinair in premature infants and newborns, as their kidneys are not yet fully developed.
Coughing and chest tightness may lead to discontinuation of treatment. This can be alleviated by using an inhaled bronchodilator (e.g. salbutamol) prior to Colfinair administration. Your doctor will monitor your first dose of Colfinair and will check your lung function before and after the dose.
If chest tightness occurs despite using a bronchodilator, contact your doctor, as this may indicate an allergic reaction and treatment should be stopped.
During treatment with Colfinair, neurotoxicity may occur, possibly causing dizziness, confusion, or visual disturbances. If you experience side effects such as dizziness, confusion, or visual disturbances, or any other unlisted side effects, inform your doctor.

Other medicines and Colfinair

• Medicines that may affect kidney function. If you take such medicines at the same time as Colfinair, the risk of kidney damage may increase.
• Medicines that may affect the nervous system. If you take such medicines at the same time as Colfinair, the risk of nervous system side effects may increase.
• Medicines called muscle relaxants, often used during general anesthesia. Colfinair may enhance the effects of these medicines. If you are given general anesthesia, inform the anesthesiologist that you are using Colfinair.

If you suffer from severe 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 Colfinair further increases the risk of muscle weakness and breathing difficulties.
If you are receiving colistimethate sodium by intravenous infusion and simultaneously using Colfinair by inhalation, the risk of adverse effects may increase.
Colfinair must not be mixed with other medicines in the nebulizer!

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Colfinair has a moderate influence on the ability to drive and use machinery. During treatment with Colfinair, neurotoxicity may occur, possibly causing dizziness, confusion, or visual disturbances. If you experience side effects such as dizziness, confusion, or visual disturbances, do not drive or operate machinery and speak to your doctor or pharmacist.

3. How to use Colfinair

Colfinair is for inhalation use.
Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is:

The doctor may decide to adjust the dose depending on the circumstances. If you are taking other inhaled medicines, the doctor will tell you in which order they should be taken.
Colfinair is also available in vials containing 2 million units, which may be a more appropriate dose depending on the dosage prescribed by the doctor.
For use in children under 2 years of age, PARI LC Sprint Baby (red nebulizer) with a mask is recommended.
The doctor will tell you how long your treatment with Colfinair will last. Do not stop treatment prematurely, because when treating bacterial infections it is important to complete the entire course of treatment to reduce the risk of development of resistance by the infecting bacteria.

Preparation for inhalation treatment
If you are treating at home, the doctor or nurse will initially show you how to use Colfinair with your nebulizer.
To begin treatment, you will need the following:

• One 10 ml vial of Colfinair 1 million units
• 3 ml of sterile sodium chloride solution 9 mg/ml (0.9%) to dissolve the powder
• An appropriate nebulizer for inhalation of Colfinair (e.g. eFlow rapid or PARI LC SPRINT)

It is important that your nebulizer functions properly before starting treatment with Colfinair.
Carefully read the instructions for use of the nebulizer and for further information on how to use the nebulization system.
Place the components of the nebulizer on a clean, flat surface and follow the manufacturer's instructions for use.

Preparing Colfinair for inhalation
Colfinair must be used immediately after reconstitution. Do not reconstitute Colfinair before you are ready to administer the dose (see also section 5).

Step 1: Take a vial of Colfinair and gently tap the
glass vial so that the powder settles to the bottom.
This ensures that you receive the correct dose.
Open the vial by lifting the red plastic overcap (Figure 1).

Step 2: Pull downwards on the red plastic overcap together with the metal ring (Figure 2).

Step 3: Tear off the red overcap with a twisting motion in the direction of the arrow. This action will properly open the metal ring. Bend the metal ring sideways using the break point on the opposite side. Remove the metal ring from the vial. Discard the ring and overcap.

Step 4: Gently remove the rubber stopper.

• Add 3 ml of sterile sodium chloride solution 9 mg/ml (0.9%) to the Colfinair 1 million units vial (red cap)

To avoid foaming, gently shake the vial until the powder is completely dissolved. Do not use Colfinair if you see visible particles in the solution after reconstitution.

Using Colfinair
Colfinair is for inhalation use with an appropriate nebulizer (e.g. eFlow-rapid or PARI LC SPRINT).
For more detailed information on the correct use of the selected nebulizer, follow the instructions in the nebulizer’s user manual.
Inhalation should take place in a well-ventilated area.

After inhalation of Colfinair
Refer to the instructions in the manufacturer’s manual for use, cleaning, and disinfection of the nebulizer.

If you use more Colfinair than you should
If you have used more Colfinair than prescribed, inform your doctor or pharmacist immediately. If an overdose of Colfinair is accidentally taken, the effects may be serious and include kidney problems, muscle weakness, and breathing difficulties (up to respiratory arrest).

If you forget to take Colfinair
If you are self-treating and have missed a dose, take the missed dose as soon as you remember, then take the next dose 8 or 12 hours later, continuing from there as instructed.
Do not take a double dose to make up for a forgotten dose.

If you stop treatment with Colfinair
Do not stop using Colfinair as prescribed without first consulting your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
An allergic reaction is possible. Severe allergic reactions may occur even after the first dose and may include rapid onset of skin rash, swelling of the face, tongue and neck, difficulty breathing due to narrowing of the airways, and loss of consciousness. Immediate medical intervention is required.
If you think you are having an allergic reaction to Colfinair, inform your doctor immediately.
Some side effects may be serious.

Very common: may affect more than 1 in 10 people

• A feeling of tightness in the chest due to narrowing of the airways (this may not always be a true allergic reaction)

Not known: frequency cannot be estimated from the available data

• In patients with severe renal impairment, higher doses may cause side effects known to occur with intravenous administration
• Confusion
• Psychotic disorder
• Visual disturbances
• Dizziness If you experience any of these symptoms, contact your doctor immediately.

Other possible side effects:
Very common: may affect more than 1 in 10 people

• Sore throat and mouth
• Cough
• Shortness of breath
• Wheezing
• Worsening of lung function test results
• Transient absence of spontaneous breathing

If any of these effects occur severely, inform your doctor.
Not known: frequency cannot be estimated from the available data

• Subjective altered skin sensation
• Speech disorders
• Vertigo
• Renal failure

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the website:
http://www.agenziafarmaco.gov.it/it/responsabili
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Colfinair

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the vial.
The expiry date refers to the last day of the month.
Do not store above 25°C.
Keep the vials in the outer packaging to protect them from light.
The Colfinair nebuliser solution must be used immediately after preparation.
If this is not possible, the Colfinair solution must not be stored above 25°C and must not be kept for longer than 24 hours.
If not used immediately, the storage times and conditions are the responsibility of the user.
Any unused solution must be discarded.
For single use only.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Colfinair contains

• The active substance is sodium colistimethate.
• Each 10 ml vial contains 1 million units equivalent to 80 mg of sodium colistimethate.

Description of the appearance of Colfinair and contents of the pack
Colfinair is a powder for solution for nebulizer.
1 million units/vial: White powder in a 10 ml clear glass vial with red cap.
Also available:
2 million units/vial: White powder in a 10 ml clear glass vial with lavender cap.
The product is available in the following pack sizes:
Carton box containing 8 cardboard pouches, each containing 7 vials (56 vials).
Plus 2 cardboard pouches of INQUA NaCl 0.9% for inhalation, each containing 30 vials of 3 ml (60 vials).
Plus eFlow-rapid portable nebulizer.

Marketing Authorization Holder
PARI Pharma GmbH
Moosstrasse 3
82319 Starnberg
Germany

Manufacturer
PARI Pharma GmbH
Moosstrasse 3
82319 Starnberg
Germany

Manufacturing site
Lochhamer Schlag 21
82166 Gräfelfing
Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
United Kingdom: ColiFin 1 MIU Powder for nebuliser solution
Germany: ColiFin 1 Mio. I.E. Pulver zur Herstellung einer Lösung für einen Vernebler
Netherlands: ColiFin PARI 1.000.000 IE poeder voor verneveloplossing
Austria: ColiFin 1 Mio. I.E. Pulver zur Herstellung einer Lösung für einen Vernebler
Spain: COLFINAIR 1 MILLION DE UI POLVO PARA SOLUCIÓN PARA INHALACIÓN POR NEBULIZADOR
Italy: Colfinair 1.000.000 UI Polvere per soluzione per nebulizzatore

This Patient Information Leaflet was last approved on
Patient Information Leaflet

Colfinair 2 Million International Units, powder for solution for nebulizer

Colistimethate sodium
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Colfinair is and what it is used for

Colfinair is administered by inhalation for the treatment of chronic chest infections in
patients with cystic fibrosis. Colfinair is used when these infections are caused by specific bacteria
called Pseudomonas aeruginosa.

2. What you need to know before using Colfinair

Do not take Colfinair

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Colfinair

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

Particular care must be taken when using Colfinair in premature infants and newborns, as their kidneys are not yet fully developed.
Coughing and chest tightness may lead to discontinuation of treatment. This can be alleviated by using an inhaled bronchodilator (e.g. salbutamol) prior to Colfinair administration. Your doctor will monitor your first dose of Colfinair and will check your lung function before and after the dose.
If chest tightness occurs despite using the bronchodilator, contact your doctor, as this may indicate an allergic reaction and treatment should be stopped.
During treatment with Colfinair, neurotoxicity may occur, possibly causing dizziness, confusion, or visual disturbances. If you experience side effects such as dizziness, confusion, or visual disturbances, or any other side effects not listed in this leaflet, inform your doctor.
Other medicines and Colfinair

• medicines that may affect kidney function. If you are taking such medicines at the same time as Colfinair, the risk of kidney damage may increase.
• medicines that may affect the nervous system. If you are taking such medicines at the same time as Colfinair, the risk of nervous system side effects may increase.
• medicines known as muscle relaxants, often used during general anaesthesia. Colfinair may enhance the effects of these medicines. If you are to receive general anaesthesia, inform the anaesthetist that you are using Colfinair.

If you suffer from severe myasthenia and are also taking other antibiotics known as macrolides (such as azithromycin, clarithromycin or erythromycin) or antibiotics known as fluoroquinolones (such as ofloxacin, norfloxacin and ciprofloxacin), taking Colfinair further increases the risk of muscle weakness and breathing difficulties.
If you are receiving colistimethate sodium by infusion and Colfinair by inhalation at the same time, the risk of side effects may increase.
Colfinair must not be mixed with other medicines in the nebulizer!
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Colfinair has a moderate influence on the ability to drive and use machines. During treatment with Colfinair, neurotoxicity may occur, possibly causing dizziness, confusion, or visual disturbances. If you experience side effects such as dizziness, confusion, or visual disturbances, do not drive or operate machinery, and discuss this with your doctor or pharmacist.

3. How to use Colfinair

Colfinair is for inhalation use.
Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is:

The doctor may decide to adjust the dose depending on the circumstances. If you are taking other inhaled medicines, the doctor will tell you in which order they should be taken.
Colfinair is also available in vials containing 1 million units, which may be a more appropriate dose depending on the dosage prescribed by the doctor.
For use in children under 2 years of age, PARI LC Sprint Baby (red dispenser) with a mask is recommended.
The doctor will tell you how long your treatment with Colfinair will last. Do not stop treatment prematurely, as when treating bacterial infections it is important to complete the full course of treatment to reduce the risk of development of resistance by the infecting bacteria.

Preparation for inhaled treatment
If you are being treated at home, the doctor or nurse will initially show you how to use Colfinair with your nebulizer.

To start treatment, you will need the following:

• One 10 ml vial of Colfinair 2 million units
• 4 ml of sterile sodium chloride solution 9 mg/ml (0.9%) for dissolving the powder
• An appropriate nebulizer for inhalation of Colfinair (e.g. eFlow rapid or PARI LC SPRINT)

It is important that your nebulizer functions properly before starting treatment with Colfinair.
Carefully read the instructions for use of the nebulizer and for further information on how to use the nebulization system.
Place the components of the nebulizer on a clean, flat surface and follow the manufacturer's instructions for use.

Preparing Colfinair for inhalation
Colfinair must be used immediately after reconstitution. Do not dissolve Colfinair before you are ready to administer the dose (see also section 5).

Step 1: Take a vial of Colfinair and gently tap the glass vial so that the powder settles at the bottom. This ensures that you receive the correct dose. Open the vial by lifting off the purple plastic overcap (Figure 1).

Step 2: Pull downwards on the purple plastic overcap together with the metal ring (Figure 2).

Step 3: Tear off the purple overcap with a twisting motion in the direction of the arrow. When performed correctly, this will open the metal ring. Bend the metal ring sideways using the break point on the opposite side. Remove the metal ring from the vial. Discard the ring and overcap.

Step 4: Gently remove the rubber stopper.

• Add 4 ml of sterile sodium chloride solution 9 mg/ml (0.9%) to the vial of Colfinair 2 million units (purple cap)

To avoid foaming, gently shake the vial until the powder is completely dissolved. Do not use Colfinair if you see visible particles in the solution after reconstitution.

Using Colfinair
Colfinair is for inhalation use with an appropriate nebulizer (e.g. eFlow-rapid or PARI LC SPRINT).
For more detailed information on the correct use of the selected nebulizer, follow the instructions in the nebulizer’s user manual.
Inhalation should take place in a well-ventilated area.

After inhalation of Colfinair
Refer to the instructions in the manufacturer’s manual for use, cleaning, and disinfection of the nebulizer.

If you use more Colfinair than you should
If you have used more Colfinair than prescribed, inform your doctor or pharmacist immediately. If an overdose of Colfinair is accidentally taken, effects may be severe and include kidney problems, muscle weakness, and breathing difficulties (up to cessation of breathing).

If you forget to take Colfinair
If you are self-treating and have missed a dose, take the missed dose as soon as possible once you remember, then take the next dose 8 or 12 hours later, continuing as directed.
Do not take a double dose to make up for a forgotten dose.

If you stop treatment with Colfinair
Do not stop using Colfinair as prescribed without first consulting your doctor.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
An allergic reaction is possible. Severe allergic reactions may occur even after the first dose and may include rapidly developing skin rash, swelling of the face, tongue and throat, difficulty breathing due to narrowing of the airways, and loss of consciousness. Immediate medical intervention is required.
If you think you are having an allergic reaction to Colfinair, inform your doctor immediately.
Some side effects may be serious.

Very common: may affect more than 1 in 10 people

• A feeling of tightness in the chest due to narrowing of the airways (this may not always be a true allergic reaction)

Not known: frequency cannot be established from the available data

• In patients with severe renal impairment, higher doses may cause side effects known to occur with intravenous administration
• Confusion
• Psychotic disorder
• Visual disturbances
• Dizziness If you experience any of these symptoms, contact your doctor immediately.

Other possible side effects:
Very common: may affect more than 1 in 10 people

• Sore throat and mouth
• Cough
• Shortness of breath
• Wheezing
• Worsening of lung function test
• Transient absence of spontaneous breathing

If any of these effects occur severely, inform your doctor.
Not known: frequency cannot be established from the available data

• Subjective altered skin sensation
• Speech disorders
• Vertigo
• Renal failure

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the website:
http://www.agenziafarmaco.gov.it/it/responsabili
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Colfinair

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the
vial. The expiry date refers to the last day of the month.
Do not store above 25°C.
Keep the vials in the outer packaging to protect them from light.
The Colfinair nebuliser solution must be used immediately after preparation.
If this is not possible, the Colfinair solution must not be stored above 25°C and must not be kept for longer than 24 hours.
If not used immediately, the storage times and conditions are the responsibility of the user.
Any unused solution must be discarded.
For single use only.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Colfinair contains

• The active substance is colistimethate sodium.
• Each 10 ml vial contains 2 million units equivalent to 160 mg of colistimethate sodium.

Description of the appearance of Colfinair and contents of the pack
Colfinair is a powder for solution for nebuliser.
2 million White powder in a 10 ml clear glass vial with a lavender-coloured cap.
Also available:
1 million White powder in a 10 ml clear glass vial with a red cap.
The product is available in the following pack sizes:
Carton box containing 8 cardboard pouches, each containing 7 vials (56 vials).
Plus 2 cardboard pouches of INQUA NaCl 0.9% for inhalation, each containing 30 vials of 4 ml (60 vials).
Plus eFlow -rapid portable nebuliser.
Marketing Authorisation Holder
PARI Pharma GmbH
Moosstrasse 3
82319 Starnberg
Germany
Manufacturer
PARI Pharma GmbH
Moosstrasse 3
82319 Starnberg
Germany
Manufacturing site
Lochhamer Schlag 21
82166 Gräfelfing
Germany
This medicinal product is authorised in the European Economic Area countries under the
following names:
United Kingdom ColiFin 2 MIU Powder for nebuliser solution
Germany ColiFin 2 Mio. I.E. Pulver zur Herstellung einer Lösung für einen Vernebler.
Netherlands ColiFin PARI 2.000.000 IE poeder voor verneveloplossing
Austria ColiFin 2 Mio. I.E. Pulver zur Herstellung einer Lösung für einen Vernebler
Spain COLFINAIR 2 MILLONES DE UI POLVO PARA SOLUCIÓN PARA
INHALACIÓN POR NEBULIZADOR
Italy Colfinair 2.000.000 UI Polvere per soluzione per nebulizzatore
This Patient Information Leaflet was last approved on