Colfinair 2 million IU powder for solution for inhalation by nebulizer
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Colfinair 2 million IU powder for solution for inhalation by nebulizer
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 questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Colfinair is and what it is used for
- What you need to know before using Colfinair
- How to use Colfinair
- Possible side effects
- How to store Colfinair
- Contents of the pack and other information
1. What Colfinair is and what it is used for
Colfinair is a nasal spray containing the active substance fluticasone propionate. It belongs to a group of medicines called corticosteroids, which help reduce inflammation. Colfinair is used to treat symptoms of allergic rhinitis (such as sneezing, runny or blocked nose, and itchy nose) and nasal polyps in adults and adolescents aged 12 years and over. It works by reducing swelling and irritation in the nasal passages.
Antibiotics are used to treat bacterial infections and are not effective against viral infections. It is important to follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment. Do not store or reuse this medication. If you have leftover antibiotics after completing the treatment, return them to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste. |
Colfinair is administered by inhalation to treat chronic respiratory infections in patients with cystic fibrosis. Colfinair is used when these infections are caused by a specific bacterium called Pseudomonas aeruginosa.
2. What you need to know before using Colfinair
Do not use Colfinair
- If you are allergic (hypersensitive) to sodium colistimethate, colistin, or other polymyxins.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to use Colfinair:
- If you have or have had kidney problems
- If you suffer from myasthenia gravis
- If you suffer from porphyria
- If you suffer from asthma.
Caution should be exercised when using Colfinair in premature infants and newborns, as their kidneys are not yet fully developed.
Coughing and chest tightness may lead to discontinuation. This can be relieved by using an inhaled bronchodilator (e.g. salbutamol) before using Colfinair. Your doctor will supervise your first dose of Colfinair and will check your lung function before and after administration.
If you experience chest tightness despite using a bronchodilator, inform your doctor, as this may indicate an allergic reaction and treatment should be stopped.
Neurotoxicity may occur during treatment with Colfinair, possibly causing dizziness, confusion, or visual disturbances. If you experience adverse effects such as dizziness, confusion, or visual disturbances, or any not mentioned in this leaflet, inform your doctor.
Taking Colfinair with other medicines
- Medicines that may affect how your kidneys work. Taking such medicines at the same time as Colfinair may increase the risk of kidney damage.
- Medicines that may affect the nervous system. Taking such medicines at the same time as Colfinair may increase the risk of adverse effects on your nervous system.
- Medicines called muscle relaxants, often used during general anesthesia. Colfinair may enhance the effects of these medicines. If you are to receive general anesthesia, inform your anesthetist that you are using Colfinair.
If you have myasthenia gravis and are also taking 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.
Receiving sodium colistimethate by intravenous infusion at the same time as receiving Colfinair by inhalation may increase your risk of experiencing adverse effects.
!Colfinair must not be mixed with any other medicine in the nebulizer!
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using 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 any adverse effects such as dizziness, confusion, or visual disturbances, do not drive or operate machinery and consult your doctor or pharmacist.
3. How to use Colfinair
Colfinair is for inhalation use only.
Always follow your doctor's instructions on how to take this medicine exactly. If in doubt, consult your doctor or pharmacist again.
Recommended dose is:
Proposed dose | Maximum dose per day | |
Adults, Adolescents (12 to 17 years), Children (2 to 11 years) | 1-2 million units two or three times daily | 6 million units |
Children under 2 years | 0.5-1 million units twice daily | 2 million units |
Your doctor may decide to adjust the dose depending on your circumstances. If you are also taking other inhaled medications, your doctor will instruct you on the order in which they should be taken.
Please note that Colfinair is also available in a vial of 1 million IU, which may be a more suitable dose depending on the prescribed posology.
For use in children under 2 years of age, PARI LC SPRINT Baby (red nozzle adapter) with a mask is recommended.
Your doctor will tell you how long your treatment with Colfinair will last. Do not stop the treatment prematurely, as it is important to complete the full course of treatment when treating bacterial infections in order to reduce the risk of development of resistance in the infecting bacteria.
Preparation for inhalation treatment
If you are being treated at home, your doctor or nurse will show you how to use Colfinair with your nebulizer when you start this treatment.
To start your treatment, you will need the following:
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How to prepare Colfinair for inhalation
Before Colfinair can be placed into the nebulizer and inhaled, it must be dissolved with 3 ml of sterile 0.9% NaCl solution for inhalation. One ampoule contains the correct volume to dissolve Colfinair.
Colfinair must be used immediately after dissolution. Do not dissolve Colfinair until you are ready to administer a dose (see also section 5).
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Step 5
- Add 4 ml of sterile inhalation solution of NaCl 0.9% to Colfinair 2 million IU (lavender cap).
- Replace the rubber stopper and gently invert the vial twice.
- Gently roll the vial between both hands to dissolve all visible Colfinair powder at the bottom and sides of the vial. Do not shake the vial too vigorously, as this may cause foaming of the solution.
- Once most of the powder has dissolved, let the vial stand undisturbed until the foam disappears and the remaining powder dissolves completely. This may take a few minutes.
Use Colfinair only when all the powder has dissolved and no visible particles remain in the solution.
How to use Colfinair
Colfinair is for inhalation use with a suitable nebulizer (e.g., eFlowrapid or PARI LC SPRINT).
Carefully read the manufacturer's instructions for use of the nebulizer for further information on handling the nebulization system.
It is important that your nebulization system is functioning properly before starting treatment with Colfinair.
Place the components of your nebulizer on a clean, flat surface and follow the manufacturer's instructions.
Inhalation should be performed in a well-ventilated room.
After inhaling Colfinair
Refer to the manufacturer's instructions for the nebulizer regarding cleaning and disinfection.
If you use more Colfinair than you should
If you have used more Colfinair than prescribed, contact your doctor or pharmacist immediately. Accidental administration of excessive amounts of Colfinair may lead to serious effects, including kidney problems, muscle weakness, and breathing difficulties (even respiratory arrest).
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, call the Toxicology Information Service at telephone number 915 620 420 (indicating the medication and amount ingested), or go to the nearest hospital.
If you forget to use 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 as directed from that point onward.
Do not take a double dose to make up for missed doses.
If you stop treatment with Colfinair
Do not discontinue using Colfinair as prescribed without first consulting your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
An allergic reaction may occur. Serious allergic reactions can happen even with the first dose, and may include rapid onset of rash, swelling of the face, tongue and neck, difficulty breathing due to narrowing of the airways, and loss of consciousness. Urgent medical attention will be required.
If you think you are having an allergic reaction to Colfinair, inform your doctor immediately.
Some adverse effects may be serious
Very common: may affect more than 1 in 10 people.
- Chest tightness due to narrowing of the airways (this may not always be a true allergic reaction)
Frequency not known: cannot be estimated from available data.
- Patients with severe renal impairment and at the highest doses may experience adverse effects known to occur with intravenous administration
- Confusion
- Psychotic disorder
- Visual disturbance
- Dizziness
If you experience any of these effects, inform your doctor immediately.
Other possible adverse effects
Very common: may affect more than 1 in 10 people.
- Mouth or throat ulcers
- Cough
- Breathing difficulty
- Wheezing
- Worsening of pulmonary function test results
- Transient absence of spontaneous breathing
If any of these problems affect you severely, inform your doctor.
Frequency not known: cannot be estimated from available data.
- Subjective skin sensations
- Speech disorder
- Vertigo
- Renal failure
Other possible adverse effects include candidiasis in the mouth or throat.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of 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 or on the label of the vial after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 25°C.
Keep the vial in the outer cardboard container to protect it from light.
Colfinair nebuliser solution should be used immediately after preparation. If this is not possible, a solution of Colfinair must be stored in the refrigerator (2°C - 8°C) and used within 24 hours.
If not used immediately, the storage conditions and times are the responsibility of the user.
Any unused solution must be discarded.
For single use only.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the container and other information
Composition of Colfinair
- The active substance is sodium colistimethate.
- Each 10 ml vial contains 2 million IU, equivalent to approximately 160 mg of sodium colistimethate.
Nature of the product and contents of the container
Colfinair is a powder for solution for inhalation by nebulizer.
2 million UI/vial: | White powder in a 10 ml colorless glass vial with a lavender stopper. |
Also available: 1 million UI/vial: | White powder in a 10 ml colorless glass vial with a red stopper. |
The product is available in the following pack sizes:
Carton box containing:
- 8 cardboard boxes of 7 vials each (56 vials),
- 2 boxes of inhalation solution NaCl 0.9% with 30 ampoules of 4 ml each (60 ampoules), and a hand-held nebulizer device eFlowrapid.
Marketing Authorization Holder and Manufacturer
PARI Pharma GmbH
Moosstrasse 3
82319 Starnberg
Germany
Tel.: +49 (0) 89/74 28 46 – 10
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
PARI Pharma Iberia S.L.
Miguel Yuste 17, 4th floor C.
28037 Madrid
This medicinal product is authorized in the European Economic Area member states under the following names:
GermanyColiFin 2 Million I.E. Powder for solution for inhalation by nebulizer
NetherlandsColiFin PARI 2,000,000 I.E. Powder for nebulizer solution
AustriaColiFin 2 Mio. I.E. Powder for solution for inhalation by nebulizer
SpainColfinair 2 million UI powder for inhalation solution for nebulizer
ItalyColfinair 2,000,000 U Powder for nebulizer solution
Date of the most recent revision of this leaflet: 05/2022
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/