Colistimethate sodium Accord 2 million IU powder for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Colistimethate sodium Accord 2 million IU powder for solution for injection and for infusion EFG

Read the entire 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Colistimetate Sodium Accord is and what it is used for

Colistimetate Sodium Accord contains the active substance colistimetate sodium. Colistimetate sodium is an antibiotic belonging to the polymyxin group.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, frequency, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Colistimetate Sodium Accord is indicated for use in adults and pediatric patients.

• By intravenous route: Colistimetate Sodium Accord is administered by injection to treat certain serious infections caused by specific bacteria. Colistimetate Sodium Accord is used when other antibiotics are not suitable.

• By inhalation route: Colistimetate Sodium Accord is administered as an inhalation to treat chronic respiratory infections in patients with cystic fibrosis. Colistimetate Sodium Accord is used when these infections are caused by a specific bacterium called Pseudomonas aeruginosa.

2. What you need to know before using Colistimethate sodium Accord

Do not use Colistimethate sodium Accord

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before starting treatment with colistimethate sodium

• If you have or have had kidney problems
• If you suffer from myasthenia gravis
• If you suffer from porphyria
• If you suffer from asthma (when used by inhalation route)
• 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 medicines

• Medicines that may affect how your kidneys work. Taking such medicines together with colistimethate sodium may increase the risk of kidney damage.
• Medicines that may affect the nervous system. Taking such medicines together with colistimethate sodium may increase the risk of adverse effects on the nervous system.
• Medicines known as muscle relaxants, often used during general anaesthesia. Colistimethate sodium can enhance the effects of these medicines. If you are due to receive general anaesthesia, inform your anaesthetist that you are taking colistimethate sodium.

If you have myasthenia gravis and are also taking other antibiotics called macrolides (such as azithromycin, clarithromycin or erythromycin), or antibiotics known as fluoroquinolones (such as ofloxacin, norfloxacin and ciprofloxacin), taking this medicine may further increase the risk of muscle weakness and breathing difficulties.

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

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.

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

Breast-feeding should be discontinued during treatment with this medicine, as it may pass into breast milk.

Driving and use of machines

Colistimethate sodium Accord may cause dizziness, confusion or visual disturbances; therefore, you should not drive or operate any tools or machinery in such cases.

Colistimethate sodium Accord contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per dose, i.e. essentially "sodium-free".

3. How to use Colistimethate Sodium Accord

Follow exactly the instructions given by your doctor or pharmacist for using this medicine. If in doubt, consult your doctor or pharmacist.

• Intravenous route:

Your doctor has prescribed colistimethate sodium as an intravenous infusion over 30 to 60 minutes.

The usual dose in adults is 9 million units, divided into two or three doses. If you are seriously ill, you may receive an initial higher dose of 9 million units at the beginning of treatment.

In some cases, your doctor may decide to administer 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 occasionally been administered.

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

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

• Inhalation route:

The usual dose in adults, adolescents, and children aged 2 years and older is 1–2 million units two or three times daily (maximum 6 million units per day).

The usual dose in children under 2 years of age is 0.5–1 million units twice daily (maximum 2 million units per day).

Your doctor may decide to adjust the dose depending on your individual circumstances. If you are also taking other inhaled medications, your doctor will advise 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Colistimethate Sodium Accord:

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

If you are receiving this medicine by intravenous route and less than 3 hours have passed since your scheduled dose, you may request administration of the missed dose. If more than 3 hours have passed since the missed dose, wait and take the next dose at the usual time.

If the administration is by inhalation, take the missed dose as soon as you remember, and then continue with your next dose at the regular time.

If you stop treatment with Colistimethate Sodium Accord

Your doctor will advise you on the duration of treatment with Colistimethate Sodium Accord. Do not discontinue treatment prematurely, as there is a risk that the infection may recur.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The adverse effects observed have been classified by organ systems and by frequency 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 the available data).

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

Possible adverse effects after intravenous administration:

Nervous system disorders

• Very common: Tingling or numbness around the lips and face, headache.
• Frequency not known: Difficulty speaking, visual disturbances, confusion, mental disturbances or flushing (redness of the face), psychosis, dizziness, vertigo, difficulty controlling movements.

Renal and urinary disorders

• Very common: This medicine may affect the kidneys, especially if the dose is high or if you are taking other medications that may affect kidney function (including increases in certain results of special kidney function tests, such as urea and creatinine).
• Rare: Renal failure.

General disorders and administration site conditions

• Very common: Muscle weakness, itching.
• Frequency not known: Allergic reactions such as skin rashes or swelling (of lips, mouth, throat). If this occurs, inform your doctor immediately, as treatment may need to be discontinued. Pain at the injection site.

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

• Muscle spasms
• Increased urine production
• Fatigue

Possible adverse effects after inhalation administration:

Respiratory, thoracic and mediastinal disorders

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

General disorders and administration site conditions

• Frequency not known: Allergic reactions such as skin rashes. If this occurs, inform your doctor immediately, as treatment may need to be discontinued. Sore throat and irritation in the mouth, which may be due to an allergy to the medicine or a superimposed fungal infection when this medicine is administered via a nebulizer.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sodium Colistimethate Accord

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

Do not use this medicine after the expiry date stated on the packaging as “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Sodium Colistimethate 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 with a concentration <80,000 IU/ml must be used immediately, as sodium colistimethate undergoes significant hydrolysis below this concentration.

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

Any remaining solution must be discarded.

Do not use this medicine if you notice any signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Pack contents and other information

Composition of Colistimethate Sodium Accord

• The active substance is colistimethate sodium.

Each vial contains 1 million international units (IU) of sodium colistimethate, equivalent to approximately 80 milligrams (mg) of colistimethate sodium.

• There are no other components.

Appearance of the product and contents of the pack

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

The powder must be dissolved in an injection or infusion solution.

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

Manufacturer

Xellia Pharmaceuticals ApS

Dalslandsgade 11

2300 Copenhagen S

Denmark

Date of the most recent revision of this leaflet: June 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/.

The following information is intended exclusively for healthcare professionals:

• Intravenous route:

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 further diluted, typically with 50 ml of 0.9% sodium chloride.

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

When administering via intrathecal or intracerebroventricular routes, the administered volume must not exceed 1 ml (reconstituted concentration of 125,000 IU/ml).

• Inhalation route using a nebulizer:

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

The reconstitution volume should be adjusted according to the instructions for use provided with the nebulizer device, and normally does not exceed 4 ml.

Once reconstituted, Colistimethate Sodium Accord can be administered using any conventional nebulizer suitable for antibiotic solutions.

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

Solutions are for single use only, and any remaining solution must be discarded.