Leaflet: information for the user

Colistimethate sodium Accord 1 million IU powder for injection / infusion EFG

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isColistimethate sodium Accordand what it is used for

2. What you need to know before starting to takeColistimethate sodium Accord

3. How to useColistimethate sodium Accord

4. Possible side effects

5. Storage ofColistimethate sodium Accord

6. Contents of the pack and additional information

Colistimetato de sodio Accord contains the active ingredient colistimetato de sodio. Colistimetato de sodio is an antibiotic belonging to the group of polimixins.

Colistimetato de sodio Accord is indicated for adults and pediatric patients who can use it.

• By intravenous route. Colistimetato de sodio Accordis administered by injection to treat some types of severe infections caused by certain bacteria.Colistimetato de sodio Accordis used when other antibiotics are not suitable.

• By inhalation route. Colistimetato de sodio Accordis administered in the form of inhalation to treat chronic respiratory infections in patients with cystic fibrosis.Colistimetato de sodio Accordis used when such infections are caused by a specific bacteria calledPseudomonas aeruginosa.

No use Colistimethate Sodium Accord

- If you are allergic (hypersensitive) to colistimethate sodium, colistin, or other polymyxins.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to usecolistimethate sodium

• If you have or have had kidney problems
• If you have myasthenia gravis
• If you have porphyria
• If you have asthma (in inhalation use).
• If you experience muscle spasms, fatigue, or increased urine production at any time, inform your doctor immediately, as these episodes may be related to a condition known as pseudo-Bartter syndrome.

Caution should be exercised when using colistimethate sodium in premature infants and newborns, as their kidneys are not yet fully developed.

Use of Colistimethate Sodium Accord with other medications

• Medications that may affect how your kidneys function. Taking these medications at the same time as colistimethate sodium may increase the risk of kidney damage
• Medications that may affect your nervous system. Taking these medications at the same time as colistimethate sodium may increase the risk of adverse effects on your nervous system
• Medications called muscle relaxants, often used during general anesthesia. Colistimethate sodium may increase the effects of these medications. If you are to receive general anesthesia, inform your anesthesiologist that you are using colistimethate sodium.

If you have 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 this medication increases the risk of muscle weakness and respiratory difficulties even further.

Receiving colistimethate sodium by infusion at the same time as receiving colistimethate sodium by inhalation may increase your risk of adverse effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Colistimethate Sodium Accord should only be administered to pregnant patients if the expected benefit outweighs any potential risk.

Breastfeeding should be discontinued during treatment with this medication, as this medication may pass into breast milk.

Driving and operating machinery

Colistimethate Sodium Accord may cause dizziness, confusion, or visual problems, which is why you should not drive or use any hazardous tools or machinery in these cases.

Colistimethate Sodium Accord contains sodium

This medication contains less than 23 mg (1 mmol) of sodium per dose, which is essentially “sodium-free”

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult with your doctor or pharmacist.

- Intravenous route:

Your doctor has prescribed colistimethate sodium as a perfusion in a vein for 30 to 60 minutes.

The usual dose in adults is 9 million units, divided into two or three doses. If you are quite ill, you will be given a single dose of 9 million units at the beginning of treatment.

In some cases, your doctor may decide to give you a higher daily dose of up to 12 million units.

The usual daily dose in children weighing up to 40 kg is 75,000 to 150,000 units per kilogram of body weight, divided into three doses.

In cases of cystic fibrosis, higher doses have been occasionally administered.

Children and adults with kidney problems, including those on dialysis, usually receive lower doses.

Your doctor will regularly monitor your renal function while you are receiving colistimethate sodium.

- Inhalation route:

The usual dose in adults, adolescents, and children 2 years or older is 1-2 million units two to three times a day (up to 6 million units per day).

The usual dose in children under 2 years is 0.5-1 million units, twice a day (up to 2 million units per day).

Your doctor may 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 to take them.

If you use more Colistimethate sodium Accord than you should:

If you have used more Colistimethate sodium Accord than you should, you may experience breathing difficulties, muscle weakness, and kidney function problems.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Colistimethate sodium Accord:

Do not take a double dose to make up for the missed doses.

If you are receiving this medication intravenously and it has not been more than 3 hours since you should have received your dose, you can request that the dose be administered to you. If more than 3 hours have passed since the missed dose, wait until the next scheduled administration.

If the administration is via inhalation, take the corresponding dose as soon as you remember and continue with the next dose normally.

If you interrupt treatment with Colistimethate sodium Accord

Your doctor will indicate the duration of treatment with Colistimethate sodium Accord. Do not discontinue treatment prematurely, as there is a risk of the infection recurring.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The observed side effects have been classified by organs and systems and by frequencies using the following convention: very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people); uncommon (may affect up to 1 in 100 people); rare (may affect up to 1 in 1,000 people); very rare (may affect up to 1 in 10,000 people); frequency not known (cannot be estimated from available data).

In the case of colistimethate sodium, these affect mainly the nervous system and kidney function. The most common side effects after nebulization are cough and difficulty breathing.

Side effects possible after intravenous administration:

Nervous system disorders

• Very common: Tingling or numbness around the lips and face, headache.
• Unknown: Difficulty speaking, visual disturbances, confusion, mental changes or flushing (face redness), psychosis, dizziness, vertigo, difficulty controlling movements.

Renal and urinary disorders

• Very common: This medicine may affect the kidney, especially if the dose is high or you are taking another medicine that may affect the kidney (including increased certain special kidney test results, such as urea and creatinine).
• Rare: Renal failure.

General disorders and administration site conditions

• Very common: Muscle weakness, itching.
• Unknown: Allergic reactions such as skin rash or swelling (lips, mouth, throat). If this occurs, inform your doctor immediately as it may be necessary to discontinue treatment. Pain at the injection site.

After intravenous administration, you may experience the following symptoms that may be related to a known disease called pseudo-Bartter syndrome (see section 2):

• Muscle spasms
• Increased urine production
• Fatigue

Side effects possible after inhalation administration:

Respiratory, thoracic and mediastinal disorders

• Very common: Nebulization of this medicine through a nebulizer may produce cough and in some people may cause chest tightness, wheezing or sensation of choking, difficulty breathing due to narrowing of the airways.

General disorders and administration site conditions

• Unknown: Allergic reactions such as skin rash. If this occurs, inform your doctor immediately as it may be necessary to discontinue treatment. Sore throat and mouth irritation that may be due to allergy to the medicine or an added fungal infection when this medicine is administered through a nebulizer.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging as “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Colistimethate Sodium Accord does not contain preservatives. After preparation, it must be used immediately. Diluted injectable solutions with a volume greater than the original vial volume and/or a concentration less than 80,000 UI/ml must be used immediately, as colistimethate sodium significantly hydrolyzes below this concentration.

In the case of intrathecal and intraventricular administration, the volume of the administered solution must not exceed 1 ml (reconstituted concentration of 125,000 UI/ml). The reconstituted solution must be administered immediately.

Any remaining solution must be discarded.

Do not use this medication if you notice any sign of deterioration.

Medications must not be disposed of through drains or trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Colistimethate Sodium Accord

• The active ingredient is colistimethate sodium.

Each vial contains 1 million international units (UI) of colistimethate sodium, which weighs approximately 80 milligrams (mg) of colistimethate sodium.

• There are no other components.

Appearance of the product and contents of the package

Colistimethate sodium Accord is a white to off-white powder that is supplied in a glass vial.

The powder must be dissolved in a solution for injection or infusion.

Colistimethate sodium Accord is supplied in packs of 10 vials.

Marketing Authorization Holder

Accord Healthcare, S.L.U.

Moll de Barcelona s/n,

World Trade Center Edifici Est 6th floor

08039 Barcelona

Responsible for manufacturing

Xellia Pharmaceuticals ApS

Dalslandsgade 11

2300 Copenhagen S

Denmark

Last review date of this leaflet: June 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/.

The followinginformation is intended exclusively for healthcare professionals:

- Intravenous route:

For bolus injection:

Reconstitute the contents of the vial with no more than 10 ml of injection water or sodium chloride 0.9%.

For infusion:

The reconstituted vial contents can be diluted, usually with 50 ml of sodium chloride 0.9%.

Reconstitute the contents of the vial with injection water or with sodium chloride 9 mg/ml (0.9% solution). The reconstituted colistimethate sodium is a clear and particle-free solution. Discard the solution if particles are observed.

When using the intrathecal and intracerebroventricular administration routes, the administered volume must not exceed 1 ml (concentrated reconstituted solution of 125,000 UI/ml).

- Inhalation route with nebulizer:

Reconstitute the contents of the vial with injection water, with a 50:50 mixture of injection water and sodium chloride 0.9%, or with sodium chloride 9 mg/ml (0.9% solution).

The reconstitution volume will be adjusted according to the usage instructions provided with the nebulizer device, and usually does not exceed 4 ml.

Once reconstituted,Colistimethate sodium Accordcan be administered with any conventional nebulizer suitable for the administration of antibiotic solutions.

The reconstituted colistimethate sodium is a clear and particle-free solution. Discard the solution if particles are observed.

The solutions are for single use and any remaining solution must be discarded.