Colistimethate sodium noridem

PACKAGE LEAFLET

Package leaflet: Information for the patient

Colistimethatum natricum Noridem, 1 000 000 i.u., powder for solution for
nebulizer
Colistimethatum natricum Noridem, 2 000 000 i.u., powder for solution for
nebulizer
Colistimethatum natricum
Please read all of this leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, contact your doctor. This includes any adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Colistimethatum natricum Noridem is and what it is used for
This medicine contains the active substance colistimethate sodium. Colistimethate sodium is an
antibiotic belonging to a group of antibiotics called polymyxins.
This medicine is administered by inhalation as a nebulized solution for the treatment of chronic
respiratory tract infections in patients with cystic fibrosis. Colistimethatum natricum Noridem is used
in cases of infection caused by the bacterium Pseudomonas aeruginosa.

2. Important information before using Colistimethatum natricum Noridem

Do not use Colistimethatum natricum Noridem

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

Warnings and precautions
Before starting treatment with Colistimethatum natricum Noridem, discuss with your doctor,
pharmacist, or nurse if:

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

Some patients may experience a sensation of chest tightness due to bronchoconstriction during
inhalation of Colistimethatum natricum Noridem. Your doctor may prescribe another inhaled medicine
to be used immediately before or after Colistimethatum natricum Noridem to prevent or treat
bronchoconstriction.
Children
Particular caution should be exercised when administering Colistimethatum natricum Noridem to
premature infants and newborns, as their kidneys are not yet fully developed.
Colistimethatum natricum Noridem and other medicines
Inform your doctor about all medicines you are currently taking or have recently taken, as well as any
medicines you plan to use.
If you are taking any of the listed medicines, you may not be able to use them simultaneously with
Colistimethatum natricum Noridem in some cases. In certain situations, your doctor may decide to
temporarily discontinue other medicines, reduce the dose of Colistimethatum natricum Noridem, or
monitor blood levels of Colistimethatum natricum Noridem to ensure you are receiving the correct
dose.

• Aminoglycoside antibiotics (such as gentamicin, tobramycin, amikacin, and netilmicin) and cephalosporins, which may affect kidney function. Concurrent use of these medicines with Colistimethatum natricum Noridem 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. Concurrent use of these medicines with Colistimethatum natricum Noridem may increase the risk of adverse effects affecting the auditory organ and other parts of the nervous system (see section 4 of this leaflet).
• Muscle relaxants, often used during general anesthesia. Colistimethatum natricum Noridem may enhance the effects of these medicines. If you are undergoing general anesthesia, inform the anesthesiologist that you are taking Colistimethatum natricum 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 Colistimethatum natricum
Noridem may further increase the risk of muscle weakness and breathing difficulties.
Concurrent intravenous infusion and inhaled administration of Colistimethatum natricum Noridem may
increase the risk of adverse effects.
Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a child, consult
your doctor or pharmacist before using this medicine.
Small amounts of Colistimethatum natricum Noridem pass into breast milk; therefore, breastfeeding is
not recommended during treatment. If you cannot stop breastfeeding while taking Colistimethatum
natricum Noridem, carefully monitor your child for signs of illness and inform your doctor if you notice
any concerning symptoms.
There are no data on the effect of Colistimethatum natricum Noridem on human fertility.
Driving and operating machinery
Colistimethate sodium may cause dizziness and visual disturbances. If you experience any adverse
effects, do not drive or operate tools or machinery.
Colistimethatum natricum Noridem contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per vial, meaning it is considered "sodium-free".
3. How to use Colistimethatum natricum Noridem
Always use this medicine exactly as prescribed by your doctor or pharmacist. If in doubt, consult your
doctor or pharmacist.
Colistimethatum natricum Noridem is inhaled into the lungs as a fine aerosol produced by a device
called a nebulizer. The aerosol droplets generated by the nebulizer are small enough to reach the
lungs, allowing Colistimethatum natricum Noridem to reach the site of bacterial infection.
The usual dose for adults, adolescents, and children aged 2 years and older is 1–2 million i.u. two to
three times daily (maximum 6,000,000 i.u. per day).
The usual dose for children under 2 years of age is 0.5–1 million i.u. twice daily (maximum 2,000,000
i.u. per day).
Your doctor may adjust the dose depending on your health condition. If you are also using other
inhaled medicines, your doctor will advise you on the correct order of administration.
Method of administration
Inhalation use.
If you are self-administering treatment at home, your doctor or nurse will demonstrate how to use
Colistimethatum natricum Noridem with a nebulizer at the start of treatment. You should sit upright
and breathe normally during inhalation. General instructions are provided below.
Preparation for nebulization
Before using Colistimethatum natricum Noridem, the medicine must be dissolved in isotonic saline
solution (normal saline).
Before starting the procedure, prepare:

• One clear glass vial containing Colistimethatum natricum Noridem, 1,000,000 i.u.
• Diluent for dissolving the powder (3 ml of isotonic saline solution)
• A nebulizer suitable for inhalation of Colistimethatum natricum Noridem, 1,000,000 i.u. (e.g., PARI LC PLUS, PARI LC SPRINT, or eFlow rapid)

Before starting the procedure, prepare:

• One clear glass vial containing Colistimethatum natricum Noridem, 2,000,000 i.u.
• Diluent for dissolving the powder (4 ml of isotonic saline solution)
• A nebul游戏副本

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Allergic reactions
After administration of Colistimethatum natricum Noridem by inhalation, patients may experience
allergic reactions. Serious adverse reactions may occur after the first dose of the medicine and
may cause sudden onset of rash, swelling of the face, tongue and neck, breathing difficulties
due to bronchoconstriction, and loss of consciousness.
If allergic reactions occur, discontinue use of Colistymethate sodium immediately and
seek medical help without delay.
Milder symptoms of allergic reactions include skin rashes, which may appear at a later stage of treatment.
The risk of allergic reactions is lower when colistymethate sodium is administered by inhalation, because only a small amount of Colistimethatum natricum Noridem enters the bloodstream when the medicine is administered by inhalation. Possible adverse reactions include cough, chest tightness due to bronchoconstriction, oral or throat pain, and fungal infections (Candida) in the mouth or throat.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
PL-02 222 Warsaw,
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl .
By reporting adverse reactions, more information on the safety of this medicine can be collected. Adverse reactions can also be reported to the responsible entity.

5. How to store Colistimethatum natricum Noridem

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and the cardboard box after "EXP". The expiry date refers to the last day of the stated 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, chemical and physical stability of the solution at a concentration ≥ 80,000 IU/mL has been demonstrated for:

• 1,000,000 IU for 3 hours at 2–8°C after dilution in 3 mL of sodium chloride solution for injection at a concentration of 9 mg/mL (0.9%) or water for injections.
• 2,000,000 IU for 3 hours at 2–8°C after dilution in 4 mL of sodium chloride solution for injection at a concentration of 9 mg/mL (0.9%) or water for injections.

From a microbiological point of view, if the method of opening/reconstitution/dilution prevents the risk of microbiological contamination, the medicinal product should be used immediately.
If not used immediately, the responsibility for storage conditions and duration of use lies with the user.
Unused portions of the solution must be discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Colistimethatum natricum 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.
No other components.

What Colistimethatum natricum Noridem looks like and contents of the pack
Colistimethatum natricum Noridem for nebuliser solution is supplied as a white or off-white powder in single-dose vials.

1,000,000 IU: Vial made of colourless glass (type I), with a 20 mm bromobutyl rubber stopper (type I) and a 20 mm aluminium cap of pull-off type in white colour or tear-off type in grey colour.

2,000,000 IU: Vial made of colourless glass (type I), with a 20 mm bromobutyl rubber stopper (type I) and a 20 mm aluminium cap of pull-off type in orange colour or tear-off type in violet colour.

Pack sizes: 1, 10 and 30 vials.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries under the following names:

Germany
Colistimethat-Natrium Noridem 1 Million I.E. Pulver zur Herstellung einer Lösung für einen Vernebler
Colistimethat-Natrium Noridem 2 Millionen I.E. Pulver zur Herstellung einer Lösung für einen Vernebler

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 Κόνις για διάλυμα για εισπνοή με εκνεφωτή
KOLELANG 2 MIU Κόνις για διάλυμα για εισπνοή με εκνεφωτή

Austria
Colistimethat-Natrium DEMO 1 Mio. I.E. Pulver zur Herstellung einer Lösung für einen Vernebler
Colistimethat-Natrium DEMO 2 Mio. I.E. Pulver zur Herstellung einer Lösung für einen Vernebler

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 Prášok na roztok pre rozprašovač
Colistimethate Noridem 2 MIU Prášok na roztok pre rozprašovač