COLISTIMETHATUM 2000000 IU Powder

Contents of the leaflet

1. LEAFLET INCLUDED IN THE PACKAGING
2. Leaflet included in the packaging: Patient information
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Colistimethate sodium Noridem and what is it used for
4. Important information before using Colistimethate sodium Noridem
   1. Do not use Colistimethate sodium Noridem
   2. Warnings and precautions
   3. Children
   4. Colistimethate sodium Noridem and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Colistimethate sodium Noridem contains sodium
5. How to use Colistimethate sodium Noridem
   1. Using a higher dose of Colistimethate sodium Noridem than recommended
   2. Missing a dose of Colistimethate sodium Noridem
   3. Stopping treatment with Colistimethate sodium Noridem
6. Possible side effects
   1. Reporting side effects
7. How to store Colistimethate sodium Noridem
8. Contents of the packaging and other information
   1. What Colistimethate sodium Noridem contains
   2. What Colistimethate sodium Noridem looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer:
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:

LEAFLET INCLUDED IN THE PACKAGING

Leaflet included in the packaging: Patient information

Colistimethate sodium Noridem, 1,000,000 IU, powder for solution for nebulizer
Colistimethate sodium Noridem, 2,000,000 IU, powder for solution for nebulizer
Colistimethate sodium

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, they should contact their doctor. This also applies to any side effects not listed in this leaflet. See section 4.

Table of contents of the leaflet

• 1. What is Colistimethate sodium Noridem and what is it used for
• 2. Important information before using Colistimethate sodium Noridem
• 3. How to use Colistimethate sodium Noridem
• 4. Possible side effects
• 5. How to store Colistimethate sodium Noridem
• 6. Contents of the packaging and other information

1. What is Colistimethate sodium Noridem and what is it used for

This medicine contains the active substance colistimethate sodium. Colistimethate sodium is an antibiotic belonging to a group of antibiotics called polymyxins.
The medicine is administered by inhalation in the form of an aerosol using a device called a nebulizer in the treatment of chronic respiratory infections in patients with cystic fibrosis. Colistimethate sodium Noridem is used in cases of infections caused by the bacterium Pseudomonas aeruginosa.

2. Important information before using Colistimethate sodium Noridem

Do not use Colistimethate sodium Noridem

• -if you are allergic to colistimethate sodium, colistin or other polymyxins .

Warnings and precautions

Before starting treatment with Colistimethate sodium Noridem, you should discuss it with your doctor, pharmacist or nurse if:

• you have or have had kidney problems
• you have myasthenia gravis (a disease characterized by muscle weakness)
• you have porphyria
• you have asthma

In some patients, a feeling of chest tightness may occur due to bronchospasm during treatment with Colistimethate sodium Noridem in the form of inhalation. Your doctor may prescribe other inhalation medications directly before or after using Colistimethate sodium Noridem to prevent or treat bronchospasm.

Children

In premature infants and newborns, special caution should be exercised when using Colistimethate sodium Noridem, as their kidneys are not yet fully developed.

Colistimethate sodium Noridem and other medicines

Tell your doctor about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
If you are taking any of the listed medicines, you may not be able to take them at the same time as Colistimethate sodium Noridem. In some cases, your doctor may decide to stop taking other medicines (for a certain period) or reduce the dose of Colistimethate sodium Noridem, or in some cases, it may be necessary to monitor the concentration of Colistimethate sodium Noridem in the blood to ensure that you are taking the correct dose.

• Aminoglycoside antibiotics (such as gentamicin, tobramycin, amikacin, and netilmicin) and cephalosporins, which may affect kidney function. Taking these medicines and Colistimethate sodium Noridem at the same time may increase the risk of kidney damage (see section 4 of this leaflet).
• Aminoglycoside antibiotics (including gentamicin, tobramycin, amikacin, and netilmicin) and cephalosporins, which may affect the nervous system. Taking such medicines at the same time as Colistimethate sodium Noridem may increase the risk of adverse reactions in the ear and other parts of the nervous system (see section 4 of this leaflet).
• Muscle relaxants, often used during general anesthesia. Colistimethate sodium Noridem may enhance the effect of these medicines. If you are going to have general anesthesia, you should tell the anesthesiologist that you are taking Colistimethate sodium Noridem.

If you have myasthenia gravis (muscle weakness) 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 Colistimethate sodium Noridem may increase the risk of muscle weakness and breathing difficulties.
Taking Colistimethate sodium Noridem by infusion at the same time as taking Colistimethate sodium Noridem by inhalation may increase the risk of adverse reactions.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before using this medicine.
Small amounts of Colistimethate sodium Noridem pass into breast milk, so breastfeeding is not recommended during treatment with Colistimethate sodium Noridem. If you cannot stop breastfeeding during treatment with Colistimethate sodium Noridem, you should carefully monitor your child for signs of illness and inform your doctor if you notice any worrying symptoms.
There is no data on the effect of Colistimethate sodium Noridem on human fertility.

Driving and using machines

Colistimethate sodium may cause dizziness and vision disturbances. If you experience side effects, you should not drive or operate any tools or machines.

Colistimethate sodium Noridem contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per vial, which means the medicine is considered "sodium-free".

3. How to use Colistimethate sodium Noridem

This medicine should always be used as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Colistimethate sodium Noridem is inhaled into the lungs in the form of a fine aerosol sprayed using a device called a nebulizer. The aerosol droplets produced by the nebulizer are small enough to reach the lungs, allowing Colistimethate sodium Noridem to reach the site of the bacterial infection.
Usually, the dose for adults, adolescents, and children over 2 years of age is 1-2 million IU 2 to 3 times a day (maximum 6,000,000 IU per day).
Usually, the dose for children under 2 years of age is 0.5-1 million IU twice a day (maximum 2,000,000 IU per day).
Your doctor may decide to modify the dose depending on your health condition. If you are taking other inhalation medicines, your doctor will advise you on the order in which to take them.
Method of administration
Inhalation.
If you are treating yourself at home, your doctor or nurse will demonstrate how to use Colistimethate sodium Noridem in a nebulizer when you start treatment for the first time. You should sit upright and breathe normally during inhalation. Below are general instructions.
Preparation for nebulization

• One glass vial of Colistimethate sodium Noridem containing 1,000,000 IU.
• Solvent for dissolving the powder (3 ml of isotonic sodium chloride solution)
• A nebulizer suitable for inhalation of Colistimethate sodium Noridem, 1,000,000 IU (e.g., PARI LC PLUS, PARI LC SPRINT, or eFlow rapid)

Before starting treatment, prepare:

• One glass vial of Colistimethate sodium Noridem containing 2,000,000 IU.
• Solvent for dissolving the powder (4 ml of isotonic sodium chloride solution)
• A nebulizer suitable for inhalation of Colistimethate sodium Noridem, 2,000,000 IU (e.g., PARI LC PLUS, PARI LC SPRINT, or eFlow rapid)

It is essential that the nebulizer system works correctly before starting treatment with Colistimethate sodium Noridem. Read the nebulizer manufacturer's instructions carefully to get more information on its use.
Place the nebulizer parts on a clean, stable surface and follow the manufacturer's instructions.
Preparing Colistimethate sodium Noridem for inhalation
Colistimethate sodium Noridem should be used immediately after dilution. Colistimethate sodium Noridem should be diluted just before administration (see section 5).
Step 1:Take one glass vial of Colistimethate sodium Noridem and gently tap it to make the powder settle at the bottom. This helps ensure that the correct dose of the medicine is administered.
Step 2:Colistimethate sodium Noridem, 1,000,000 IU: Add the solvent (3 ml of isotonic sodium chloride solution)to the appropriate vial to dissolve the powder.
Colistimethate sodium Noridem, 2,000,000 IU: Add the solvent (4 ml of isotonic sodium chloride solution)to the appropriate vial to dissolve the powder.
To prevent foaming, gently shake the vial to ensure the powder is completely dissolved. Pour the solution into the nebulizer. Do not administer Colistimethate sodium Noridem if the solution contains solid particles after dissolution.
Colistimethate sodium Noridem should be administered immediately after preparing the solution. Any unused solution should be discarded.
Using Colistimethate sodium Noridem
Colistimethate sodium Noridem is intended for inhalation using a suitable nebulizer (e.g., PARI LC PLUS, PARI LC SPRINT, or eFlow rapid). For more detailed information on the proper use of the chosen nebulizer, refer to the nebulizer's user manual. Inhalation should take place in a well-ventilated area.
After inhaling Colistimethate sodium Noridem
Refer to the nebulizer manufacturer's instructions for cleaning and disinfecting.
IMPORTANT: Do not mix Colistimethate sodium Noridem with any other medicinal product for nebulization at the same time.
Duration of treatment
In the case of nebulization, your doctor will inform you about the course of treatment.

Using a higher dose of Colistimethate sodium Noridem than recommended

If you think you have taken a dose of Colistimethate sodium Noridem higher than recommended, you should immediately inform your doctor or nurse. If you cannot contact your doctor or nurse, contact the nearest emergency department or go to the nearest hospital emergency department.
Accidental administration of an excessive dose of Colistimethate sodium Noridem may cause serious side effects such as kidney function disorders, muscle weakness, and breathing difficulties (or even respiratory arrest).
If you are being treated in a hospital or at home by a doctor or nurse and think you may have missed a dose or received too much Colistimethate sodium Noridem, you should ask your doctor, nurse, or pharmacist.

Missing a dose of Colistimethate sodium Noridem

In case of missing a dose during self-treatment, you should take the missed dose as soon as possible, and then take the next dose after 8 hours if Colistimethate sodium Noridem is administered three times a day, or after 12 hours if Colistimethate sodium Noridem is administered twice a day. Then, you should continue with the regular administration of the medicine. Do not take a double dose to make up for the missed dose.

Stopping treatment with Colistimethate sodium Noridem

Do not stop treatment prematurely unless your doctor advises you to do so. Your doctor will decide how long the treatment should last.
If you have any further 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.
Allergic reactions
After administration of Colistimethate sodium Noridem in the form of inhalation, patients may experience allergic reactions. Serious side effects can occur after the first dose of the medicine and can cause sudden onset of rash, swelling of the face, tongue, and throat, difficulty breathing due to bronchospasm, and loss of consciousness.
In case of allergic reactions, stop using Colistimethate sodium Noridem and seek medical help immediately.
Milder symptoms of allergic reactions include skin rashes, which may appear later in the treatment.
The risk of allergic reactions is lower in the case of colistimethate sodium administered by inhalation, as a small amount of Colistimethate sodium Noridem enters the bloodstream when the medicine is administered by inhalation. Possible side effects include cough, feeling of chest tightness due to bronchospasm, pain in the mouth or throat, and fungal infections (Candida) in the mouth or throat.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181C
PL-02 222 Warsaw,
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl .
By reporting side effects, you can help provide more information on the safety of this medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Colistimethate sodium Noridem

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and carton after "EXP". The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Reconstituted solution:
Hydrolysis of colistimethate is significantly increased after dissolution and dilution below the critical micellar concentration of approximately 80,000 IU/ml.
Solutions below this concentration should be used immediately.
After reconstitution in the original vial, the chemical and physical stability of the solution with a concentration of ≥ 80,000 IU/ml has been demonstrated for:

• 1,000,000 IU for 3 hours at a temperature of 2-8°C after dilution in 3 ml of sodium chloride injection solution at a concentration of 9 mg/ml (0,9%) or water for injection.
• 2,000,000 IU for 3 hours at a temperature of 2-8°C after dilution in 4 ml of sodium chloride injection solution at a concentration of 9 mg/ml (0,9%) or water for injection.

From a microbiological point of view, if the method of opening/reconstitution/dilution prevents the risk of microbial contamination, the medicinal product should be used immediately.
If the product is not used immediately, the user is responsible for the storage time and conditions.
Unused solution should be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Colistimethate sodium Noridem contains

The active substance is colistimethate sodium.
One vial contains 1,000,000 IU of colistimethate sodium.
One vial contains 2,000,000 IU of colistimethate sodium.
There are no other ingredients.

What Colistimethate sodium Noridem looks like and contents of the pack

Colistimethate sodium Noridem powder for solution for nebulizer is supplied in the form of a white or off-white powder in single-dose vials.
1,000,000 IU: Vial made of colorless glass (type I), with a 20 mm bromobutyl rubber stopper (type I) and a 20 mm aluminum cap, pull-off type, white or tear-off type, gray.
2,000,000 IU: Vial made of colorless glass (type I), with a 20 mm bromobutyl rubber stopper (type I) and a 20 mm aluminum cap, pull-off type, orange or tear-off type, purple.
Pack sizes: 1, 10, and 30 vials
Not all pack sizes may be marketed.

Marketing authorization holder:

Noridem Enterprises Limited, Evagorou & Makariou,
Mitsi Building 3, Office 115, Nicosia 1065, Cyprus

Manufacturer:

DEMO S.A. PHARMACEUTICAL INDUSTRY,
21st km National Road Athens-Lamia, 14568 Krioneri, Attiki, Greece,
T: +30 210 8161802, F: +30 2108161587.

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany
Colistimethat-Natrium Noridem 1 Million IU Powder for nebuliser solution
Colistimethat-Natrium Noridem 2 Million IU Powder for nebuliser solution
Ireland
Colistimethate sodium 1 million IU Powder for nebuliser solution
Colistimethate sodium 2 million IU Powder for nebuliser solution
Czech Republic
Colistimethate Noridem
Colistimethate Noridem
Greece
KOLELANG 1 MIU Powder for solution for inhalation with nebulizer
KOLELANG 2 MIU Powder for solution for inhalation with nebulizer
Austria
Colistimethat-Natrium DEMO 1 Mio. IU Powder for nebuliser solution
Colistimethat-Natrium DEMO 2 Mio. IU Powder for nebuliser solution
Italy
Colistimetato sodico Noridem
Colistimetato sodico Noridem
Poland
Colistimethatum natricum Noridem, 1,000,000 IU
Colistimethatum natricum Noridem, 2,000,000 IU
Slovakia
Colistimethate Noridem 1 MIU Powder for solution for nebulizer
Colistimethate Noridem 2 MIU Powder for solution for nebulizer
Date of last revision of the leaflet: