Colistimethate sodium Accord Pharma

Package leaflet: Information for the user

Colistimetate sodium Accordpharma 1 million IU powder for injectable/infusion solution
Colistimetate sodium Accordpharma 2 million IU powder for injectable/infusion solution
colistimethate sodium
Equivalent medicine
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, consult your doctor, pharmacist, or nurse.
• 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, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Colistimetate sodium Accordpharma is and what it is used for

Colistimetate sodium Accordpharma contains the active substance colistimethate sodium. Colistimethate sodium is an antibiotic belonging to the class of antibiotics known as polymyxins.
Colistimetate sodium Accordpharma is administered by injection for the treatment of certain types of serious infections caused by specific bacteria. Colistimetate sodium Accordpharma is used when other antibiotics are not suitable.

2. What you need to know before using

Do not use Colistimethate Sodium Accordpharma

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Colistimethate Sodium Accordpharma

• if you have or have had kidney problems.
• if you suffer from severe myasthenia gravis.
• if you suffer from porphyria.
• if at any time you experience muscle spasms, fatigue, or increased urine output, inform your doctor immediately, as these symptoms may be related to a condition known as pseudo-Bartter syndrome.

Children
Particular caution must be exercised when using Colistimethate Sodium Accordpharma in premature infants and newborns, as their kidneys are not yet fully developed.

Other medicines and Colistimethate Sodium Accordpharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If you are taking any of the following medicines, you may or may not be able to take Colistimethate Sodium Accordpharma. Sometimes other medicines may need to be discontinued (even temporarily), or the dose of Colistimethate Sodium Accordpharma may need to be reduced, or you may require monitoring during treatment with Colistimethate Sodium Accordpharma. In some cases, it may be necessary to periodically measure blood levels of Colistimethate Sodium Accordpharma to ensure you are receiving the correct dose.

Medicines such as aminoglycoside antibiotics (including gentamicin, tobramycin, amikacin, and netilmicin) and cephalosporins, which may affect kidney function. If you take these medicines together with Colistimethate Sodium Accordpharma, the risk of kidney damage may increase (see section 4 of this leaflet).

Medicines such as aminoglycoside antibiotics (including gentamicin, tobramycin, amikacin, and netilmicin), which may affect the nervous system. If you take these medicines together with Colistimethate Sodium Accordpharma, the risk of adverse effects on the ear and other parts of the nervous system may increase (see section 4 of this leaflet).

Medicines known as muscle relaxants, often used during general anesthesia. Colistimethate Sodium Accordpharma may enhance the effects of these medicines. If you are given a general anesthetic, inform the anesthetist that you are taking Colistimethate Sodium Accordpharma.

If you have severe myasthenia gravis 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 Colistimethate Sodium Accordpharma further increases the risk of muscle weakness and breathing difficulties.

Pregnancy and breastfeeding

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

Pregnancy
There are insufficient data on use in pregnant women. Your doctor will administer this medicine only if the potential benefits outweigh the potential risks to the fetus.

Breastfeeding
Small amounts of Colistimethate Sodium Accordpharma pass into breast milk. Breastfeeding is not recommended during treatment.

Driving and using machines
When Colistimethate Sodium Accordpharma is administered intravenously, adverse effects such as dizziness, confusion, or vision problems may occur. If this happens, you must not drive or operate machinery.

Colistimethate Sodium Accordpharma contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e., essentially “sodium-free”.

3. How to use Colistimetato sodico Accordpharma

Depending on the reason for which it has been prescribed to you (see section 1 of this leaflet), Colistimetato sodico Accordpharma may be administered by rapid injection (lasting 5 minutes, through a special tube inserted into a vein) or by slow injection (infusion lasting approximately 30–60 minutes) into a vein. Colistimetato sodico Accordpharma may occasionally be administered by injection into the brain or spinal cord.
Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

For use by infusion or injection:
The usual daily dose for adults is 9 million units, divided into two or three doses. If you are quite ill, you may receive a higher initial dose of 9 million units once at the beginning of treatment.
In some cases, your doctor may decide to administer a higher daily dose, up to a maximum of 12 million units.
The usual daily dose for children weighing up to 40 kg is 75,000–150,000 units per kilogram of body weight, divided into three doses.
Children and adults with kidney problems, even those undergoing dialysis, usually receive lower doses.
Your doctor will regularly monitor your kidney function while you are receiving Colistimetato sodico Accordpharma.

Method of administration
Colistimetato sodico Accordpharma is primarily administered by injection in hospital settings.
Colistimetato sodico Accordpharma will be given to you by your doctor as an intravenous infusion lasting 30–60 minutes. If you are to be treated at home, your doctor, pharmacist, or nurse will show you how to dissolve the powder and inject the correct dose of solution.

Duration of treatment
Your doctor will determine the duration of treatment depending on the severity of the infection. In treating bacterial infections, it is important to complete the full course of therapy to prevent worsening of the existing infection.

If you use more Colistimetato sodico Accordpharma than you should
If you think you have administered too much Colistimetato sodico Accordpharma, contact your doctor or nurse immediately, or, if they are unavailable, contact or go to the nearest hospital. If you accidentally receive an excessive dose of Colistimetato sodico Accordpharma, serious adverse effects may occur, including kidney problems, muscle weakness, and breathing difficulties (or even respiratory arrest).
If you are being treated in hospital or at home under the supervision of a doctor or nurse and think you may have missed a dose or received an excessive dose of Colistimetato sodico Accordpharma, consult your doctor, nurse, or pharmacist.

If you forget to use Colistimetato sodico Accordpharma
If you self-administer Colistimetato sodico Accordpharma and have missed a dose, take the missed dose as soon as you remember, then take the next dose either 8 hours later (if you are using Colistimetato sodico Accordpharma three times daily) or 12 hours later (if you are using it twice daily). Continue as instructed. Do not take a double dose to make up for a forgotten dose.

If you stop using Colistimetato sodico Accordpharma
Do not stop treatment prematurely unless your doctor tells you to do so. Your doctor will decide the duration of treatment. 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 will experience them.
The following symptoms may occur after intravenous administration, which could be related to a condition known as pseudo-Bartter syndrome (see section 2):

• muscle spasms
• increased urine production
• fatigue

Allergic reactions
When Colistimetato sodico Accordpharma is administered into a vein, it may cause an allergic reaction. Serious allergic reactions may occur even after the first dose, including sudden onset of skin rashes, swelling of the face, tongue and neck, difficulty breathing due to narrowing of the airways, and loss of consciousness.
If you experience signs of an allergic reaction, seek medical help immediately.
Less severe allergic reactions include skin rashes that appear later during treatment.

Side effects associated with intravenous injection of Colistimetato sodico Accordpharma
Nervous system side effects are more likely to occur when the dose of Colistimetato sodico Accordpharma is too high, in patients with kidney problems, or in those also receiving muscle relaxants or other medicines with similar effects on nerve function.
The most serious of these possible nervous system side effects is inability to breathe due to paralysis of the chest muscles. If you experience difficulty breathing, seek medical help immediately.
Other possible side effects include numbness or tingling (especially around the face), dizziness or loss of balance, rapid changes in blood pressure or blood flow (including fainting and flushing), difficulty speaking, vision problems, confusion, and mental disturbances (including loss of sense of reality). Reactions at the injection site, such as irritation, may also occur.

Kidney problems may also occur. These are more likely in patients who already have kidney problems, in those receiving Colistimetato sodico Accordpharma together with other medicines that may cause kidney-related side effects, or in those receiving excessive doses of Colistimetato sodico Accordpharma. These kidney problems usually improve when treatment is stopped or the dose of Colistimetato sodico Accordpharma is reduced.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Colistimetato sodico Accordpharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and on the packaging after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Diluted solutions of this medicine should be used immediately or within 24 hours if stored in a refrigerator (2 to 8°C), depending on the concentration and how the medicine is used.
If not used immediately, the storage times and conditions during use are the responsibility of the user.
The solution should appear as a clear, colourless to pale yellow liquid, free from visible particles.
Any unused solution must be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Colistimetato sodico Accordpharma contains
The active substance is colistimethate sodium.
Each vial contains 1 million or 2 million units of colistimethate sodium.
It does not contain any other components.

Description of the appearance of Colistimetato sodico Accordpharma and contents of the pack
Colistimetato sodico Accordpharma 1 million international units is a white lyophilized powder
available in a 10 mL clear glass vial.
Colistimetato sodico Accordpharma 2 million international units is a white lyophilized powder
available in a 10 mL clear glass vial.

Pack sizes
1 x 1 vial
1 x 10 vials
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona, s/n,
Edifici Est 6ª planta 08039-
Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp.z o.o.
ul. Lutomierska 50,
95-200 Pabianice,
Poland
OR
Laboratori Fundació Dau
C/ C, 12-14 Pol. Ind.
Zona Franca, Barcelona, 08040,
Spain
OR
Accord Healthcare single member S.A.
64th Km National Road Athens,
Lamia, Schimatari, 32009,
Greece

United Kingdom (Northern Ireland) with the following names:
Member State Medicinal product name
Austria Colistimethat-Natrium Accord 1 Mio. I.E. Pulver zur Herstellung einer Injektions-/Infusionslösung
Colistimethat-Natrium Accord 2 Mio. I.E. Pulver zur Herstellung einer Injektions-/Infusionslösung
Belgium NL: Colistimethaat Accord 1 miljoen Internationale Eenheden (IE) poeder voor oplossing voor injectie/infusie
FR: Colistimethaat Accord 1 million (UI) poudre pour solution injectable/pour perfusion
DE: Colistimethaat Accord 1 Million (IE) Pulver zur Herstellung einer Injektions-/Infusionslösung
Denmark Kolistimetatnatrium Accord 1 million IE, pulver til opløsning til injektion/infusion
Estonia Colistimethate sodium Accord
Germany Colistimethat-Natrium Accord 1 Million I.E. Pulver zur Herstellung einer Injektions-/Infusionslösung
Colistimethat-Natrium Accord 2 Millionen I.E. Pulver zur Herstellung einer Injektions-/Infusionslösung
Lithuania Colistimethate sodium Accord 1 000 000 TV milteliai injekciniam ar infuziniam tirpalui
Netherlands Colistimethaatnatrium Accord 1 miljoen IE, poeder voor oplossing voor injectie / infusie
Colistimethaatnatrium Accord 2 miljoen IE, poeder voor oplossing voor injectie / infusie
Sweden Kolistimetatnatrium Accord 1 miljon IE pulver till injektions-/infusionsvätska, lösning
Bulgaria Colistimethate sodium Accord 1 million IU powder for solution for injection/infusion

The following information is intended exclusively for healthcare professionals:

Special precautions for disposal and other handling
For bolus injection:
Reconstitute the vial contents with no more than 10 mL of Water for Injections or 0.9% sodium chloride.
For infusion:
The reconstituted vial contents may be diluted, usually with 50 mL of 0.9% sodium chloride.
When administering via intrathecal and intracerebroventricular routes, the administered volume must not exceed 1 mL (reconstituted concentration 125,000 IU/mL).
Any unused medicinal product or waste material must be disposed of in accordance with local regulations. The solution after reconstitution should be a clear, colourless to pale yellow solution, free from visible particles. The solutions are for single use only and any remaining solution must be discarded.