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COLIFIN 1 MIU POWDER FOR NEBULISER SOLUTION

Active substance(s): COLISTIMETHATE SODIUM

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1

WHAT COLIFIN® IS AND WHAT IT IS
USED FOR

ColiFin® is given as an inhalation to treat chronic
chest infections in patients with cystic fibrosis.
ColiFin® is used when these infections are caused
by specific bacteria called Pseudomonas aeruginosa.

Package leaflet:
Information for the user

ColiFin® 1 Million International Units
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 or pharmacist.
• 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
or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

2

WHAT YOU NEED TO KNOW BEFORE
YOU USE COLIFIN®

Do not use ColiFin®
• 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 ColiFin®
• 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 ColiFin® as the kidneys are not yet fully developed.
Coughing and chest tightness may lead to discontinuation. This may be relieved by using an inhaled
bronchodilator (e.g. salbutamol) before using
ColiFin®. Your doctor will supervise your first dose
of ColiFin® and check your lung function before
and after dosing.
If chest tightness occurs despite the use of a bronchodilator, please tell your doctor because this
may indicate an allergic reaction and the treatment should be discontinued.
During treatment with ColiFin® neurotoxicity may
occur with the possibility of dizziness, confusion
or visual disturbance. If you do experience any
side effects such as dizziness, confusion or visual
disturbance or also ones not listed in this patient
information, please tell your doctor.

Other medicines and ColiFin®
• medicines which can affect how your kidneys
function. Taking such medicines at the same
time as ColiFin® can increase the risk of damage
to the kidneys
• medicines which can affect your nervous system. Taking such medicines at the same time
as ColiFin® can increase the risk of side effects in
your nervous system
• medicines called muscle relaxants, often used
during general anaesthesia. ColiFin® can increase the effects of these medicines. If you
have a general anaesthetic, let your anaesthetist
know that you are having ColiFin®
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 ColiFin®
further increases the risk of muscle weakness and
breathing difficulties.
Having colistimethate sodium as an infusion at the
same time as receiving ColiFin® as an inhalation
can increase your risk of side effects.
ColiFin® should not be mixed with any other drugs
in the nebuliser!
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
ColiFin® has moderate influence on the ability to
drive and use machines. During treatment with
ColiFin® neurotoxicity may occur with the possibility of dizziness, confusion or visual disturbance. If
you do experience any side effects, such as dizziness, confusion or visual disturbance do not drive
or operate machines and talk to your doctor or
pharmacist.

3

HOW TO USE COLIFIN®

ColiFin® is for inhalation use.
Always use this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Proposed
Dose
Adults,
Adolescents
(age 12 years to
17 years),
Children
(age 2 years to
11 years)
Children less
than 2 years

1 – 2 million
units
two to three
times per day

Maximum
dose per
day

6 million
units

To start your treatment, you will need the
following:
• One 10 ml vial of ColiFin® 1 million units
• Sterile sodium chloride 9 mg/ml (0.9%)
solution 3 ml for dissolving the powder
• A nebuliser appropriate for inhalation use of
ColiFin® (e.g. eFlow®rapid or PARI LC SPRINT®)
It is important that your nebuliser system functions properly before starting your treatment with
ColiFin®.
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 ColiFin® for Inhalation

0.5 – 1 million
units
twice daily

2 million
units

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 take them in.

ColiFin® must be used immediately after dissolution. Do not dissolve ColiFin® until ready to administer a dose (see also section 5).
1

Please note ColiFin® is also available as 2 million
units vial that might be a more suitable dose depending on the posology prescribed by the doctor.

For use in children younger than 2 years the PARI
LC SPRINT® BABY (red nozzle insert) with mask is
recommended.
Your doctor will tell you how long your treatment
with ColiFin® 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.
Preparation for inhalation treatment
If you are treating yourself at home, your doctor
or nurse will show you how to use ColiFin® in your
nebuliser when you first start this treatment.

2

3

Step 1: Take one vial of ColiFin® 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 vial
by lifting up the red plastic overcap
on the top (Figure 1).
Step 2: Pull down the red plastic
overcap together with the metal
ring (Figure 2).

Step 3: Tear the red overcap with a
twisting movement in the direction
of the arrow. Correct performance
will allow you to tear the metal ring
open. Tear the metal ring sideways
so that the breaking point on the
opposite side bends. Remove the
metal ring from the vial. Safely dispose of the ring and overcap.

4

Step 4: Carefully remove the rubber
stopper.

If you stop using ColiFin®
You should not stop using ColiFin® as prescribed
without first consulting with your doctor.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

• Add 3 ml of sterile sodium chloride 9 mg/ml
(0.9%) solution to ColiFin® 1 million units
vial (red cap)
In order to avoid foaming, shake the vial gently
until all powder is dissolved. Do not use ColiFin®
if you notice visible particles in the solution after
dissolution.
Using your ColiFin®
ColiFin® is for inhalation use with an appropriate
nebuliser (e.g. eFlow®rapid or PARI LC SPRINT®).
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 ColiFin®
Please refer to the manufacturer’s instructions for
use of the nebuliser for cleaning and disinfecting
instructions.
If you use more ColiFin® than you should
If you have used more ColiFin® than you should,
talk to a doctor or pharmacist immediately. If too
much ColiFin® is accidentally given, the effects
can be serious and can include kidney problems,
muscle weakness and difficult (or even stopping)
breathing.
If you forget to use ColiFin®
If you are treating yourself and have missed any
doses, you should give the missed dose as soon
as you remember and then give the next dose at
8 or 12 hours later and carry on from there as instructed.
Do not use a double dose to make up for a forgotten dose.

4

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
An allergic reaction is possible. Serious allergic reactions can happen even with the very first dose and
can include rapid development of rashes, swelling
of face, tongue and neck, inability to breathe due
to narrowing of airways and loss of consciousness.
Urgent medical attention is needed.
If you think you are having an allergic reaction
to ColiFin®, tell your doctor immediately.

Some side effects can 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 (may not always be a true
allergic reaction)
Not known (frequency cannot be estimated from
the available data)
• Patients with severe renal impairment and higher dosages may experience side effects known
for intravenous administration
• Confusion
• Psychotic disorder
• Visual disturbance
• Dizziness
If you experience any of these, tell your doctor
straight away.
Other possible side effects:
Very common (may affect more than 1 in 10 people)
• mouth or throat sore
• Coughing
• Shortness of breath
• Wheezing

• Worsening of lung function test results
• Transient absence of spontaneous respiration
If any of these affects you severely, tell your doctor.
Not known (frequency cannot be estimated from
the available data)
• Subjective skin sensations
• Speech disorder
• Vertigo
• Renal failure
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any 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 COLIFIN®

Keep this medicine out of the sight and reach of
children.

throw away medicines you no longer use. These
measures will help protect the environment.

6

CONTENTS OF THE PACK AND
OTHER INFORMATION

What ColiFin® contains
• The active substance is colistimethate sodium.
• Each 10 ml vial contains 1 million units equivalent to 80 mg of colistimethate sodium.
What ColiFin® looks like and contents of the
pack

ColiFin® is a powder for nebuliser solution.
1 million
units/vial:

White powder in a 10 ml colourless glass vial with a red cap.

Also available:
2 million
units/vial:

White powder in a 10 ml colourless glass vial with a lavender cap.

Cardboard box containing 8 cardboard boxes
of 7 vials each (56 vials) plus 2 cardboard boxes
INQUA® NaCl 0.9% for inhalation containing 30 vials à 3 ml each (60 vials) plus eFlow®rapid nebuliser
handset

Do not store above 25 °C.
Keep the vials in the outer carton in order to protect from light.

Marketing Authorisation Holder and Manufacturer

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

Deutschland:
Tel.: +49 (0)89 74 28 46-10
Italia:
Tel.: +49 (0)89 74 28 46-10
Österreich:
Tel.: +49 (0)89 74 28 46-10
Espania:
Tel.: +49 (0)89 74 28 46-10
This leaflet was last revised in 03/2016

The product is available in the following pack size:

Do not use this medicine after the expiry date
which is stated on the carton and on the vial label. The expiry date refers to the last day of that
month.

ColiFin® solution for nebulisation should be used
immediately after preparation. If this is not possible, a ColiFin® solution should not be stored above
25 °C and not longer than 24 hours.
If not used immediately, in-use storage times and
conditions are the responsibility of user.

Nederland:
Tel.: +49 (0)89 74 28 46-10

PARI Pharma GmbH
Moosstr. 3
82319 Starnberg
Germany
Tel.: +49(0)89 74 28 46-10
E-Mail: info@paripharma.com
For any information about this medicine, please
contact the local representative of the Marketing
Authorisation Holder:
United Kingdom:
PARI MEDICAL Ltd.
Tel.: +44 (0) – 1932 341122

200D2000D

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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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