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SODIUM COLISTIMETHATE ACCORD 1 Million IU POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

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How to use SODIUM COLISTIMETHATE ACCORD 1 Million IU POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Sodium Colistimethate Accord 1 million IU powder for solution for injection/infusion EFG

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

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Text on a white background explaining the use of antibiotics and the importance of following medical instructionsSodium Colistimethate Accord contains the active substance sodium colistimethate. Sodium colistimethate is an antibiotic belonging to the polymyxin group.

Sodium Colistimethate Accord is indicated for adults and pediatric patients who can use it.

  • By intravenous route. Sodium Colistimethate Accord is administered by injection to treat certain severe infections caused by certain bacteria. Sodium Colistimethate Accord is used when other antibiotics are not suitable.
  • By inhalation route. Sodium Colistimethate Accord is administered in the form of inhalation to treat chronic respiratory infections in patients with cystic fibrosis. Sodium Colistimethate Accord is used when such infections are caused by a specific bacterium called Pseudomonas aeruginosa.
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2. What you need to know before you use Sodium Colistimethate Accord

Do not use Sodium Colistimethate Accord

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use sodium colistimethate

  • 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 disease known as pseudo-Bartter syndrome.

In premature infants and newborns, caution should be exercised when using sodium colistimethate because the kidneys are not yet fully developed.

Use of Sodium Colistimethate Accord with other medicines

  • medicines that may affect how your kidneys work. Taking these medicines at the same time as sodium colistimethate may increase the risk of kidney damage
  • medicines that may affect the nervous system. Taking these medicines at the same time as sodium colistimethate may increase the risk of side effects on your nervous system
  • medicines called muscle relaxants, often used during general anesthesia. Sodium colistimethate may increase the effects of these medicines. If you are going to be given a general anesthetic, inform your anesthesiologist that you are using sodium colistimethate.

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 medicine increases the risk of muscle weakness and breathing difficulties.

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

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

Breastfeeding should be interrupted during treatment with this medicine, as this medicine may pass into breast milk.

Driving and using machines

Sodium Colistimethate Accord may cause dizziness, confusion, or vision problems, so you should not drive or use any tool or machinery in these cases.

Sodium Colistimethate Accord contains sodium

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

3. How to use Sodium Colistimethate Accord

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

  • Intravenous route:

Your doctor has prescribed sodium colistimethate as an infusion 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 very ill, you will be given a larger dose, 9 million units, once at the start of treatment.

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

The usual daily dose in children who weigh 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 administered occasionally.

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

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

  • Inhalation route:

The usual dose in adults, adolescents, and children over 2 years is 1-2 million units, two or 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 decide to adjust the dose depending on your circumstances. If you are taking other inhaled medicines, your doctor will tell you in what order to take them.

If you use more Sodium Colistimethate Accord than you should:

If you have used more Sodium Colistimethate Accord than you should, you may have breathing problems, muscle weakness, and kidney problems.

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

If you forget to use Sodium Colistimethate Accord:

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

In case you are receiving this medicine by intravenous route and as long as it has not been more than 3 hours since the time you should have received your dose, you can ask to be given the corresponding dose. If more than 3 hours have passed since the forgotten dose, wait until the next administration.

In the case of inhalation administration, take the corresponding dose as soon as you remember and continue with the next dose normally.

If you stop treatment with Sodium Colistimethate Accord

Your doctor will indicate the duration of treatment with Sodium Colistimethate Accord. Do not stop treatment before, as there is a risk that the infection will recur.

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

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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects observed 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 the available data).

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

Possible side effects 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 (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 you are taking other medication that may affect the kidneys (including increased results of certain special kidney tests, such as urea and creatinine).
  • Rare: Kidney failure.

General disorders and administration site conditions

  • Very common: Muscle weakness, itching.
  • Unknown: Allergic reactions such as skin rashes or swelling (of lips, mouth, throat). If this happens, tell your doctor immediately because it may be necessary to stop treatment. Pain at the injection site.

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

  • muscle spasms
  • increased urine production
  • fatigue

Possible side effects after inhalation administration:

Respiratory, thoracic, and mediastinal disorders

  • Very common: Nebulization of this medicine may cause cough and wheezing, and may cause chest tightness, wheezing, or shortness of breath in some people.

General disorders and administration site conditions

  • Unknown: Allergic reactions such as skin rashes. If this happens, tell your doctor immediately because it may be necessary to stop treatment. Sore throat and irritation in the mouth that may be due to allergy to the medicine or an additional fungal infection when this medicine is administered through a nebulizer.

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is stated on the carton as "EXP". The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Sodium Colistimethate Accord does not contain preservatives. After preparation, it should be used immediately. Solutions for injection diluted with more volume than the original vial volume and/or with a concentration <80,000 IU/ml should be used immediately, as sodium colistimethate is significantly hydrolyzed below this concentration.

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

Any remaining solution should be discarded.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Sodium Colistimethate Accord

  • The active substance is sodium colistimethate.

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

  • There are no other ingredients.

Appearance and pack contents

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

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

Sodium Colistimethate 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 6ªplanta

08039 Barcelona

Manufacturer

Xellia Pharmaceuticals ApS

Dalslandsgade 11

2300 Copenhagen S

Denmark

Date of last revision of this leaflet: June 2023

Detailed and updated 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 injection or sodium chloride 0.9%.

For infusion:

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

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

When using the intrathecal and intraventricular routes of administration, the administered volume should not exceed 1 ml (reconstituted concentration of 125,000 IU/ml).

  • Inhalation route with nebulizer:

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

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

Once reconstituted, Sodium Colistimethate Accord can be administered with any conventional nebulizer suitable for the administration of antibiotic solutions.

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

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

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Discuss questions about SODIUM COLISTIMETHATE ACCORD 1 Million IU POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Daniel Cichi

Family medicine 24 years exp.

Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance.

His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation.

Patients commonly consult Dr Daniel Cichi for:

  • acute symptoms: fever, infections, flu-like illness, cough, sore throat, shortness of breath;
  • chest discomfort, palpitations, dizziness, fatigue, and blood pressure concerns;
  • digestive problems: abdominal pain, nausea, diarrhoea, constipation, reflux;
  • muscle, joint, and back pain, minor injuries, post-traumatic symptoms;
  • chronic conditions: hypertension, diabetes, high cholesterol, thyroid disorders;
  • review and interpretation of lab tests, imaging reports, and medical documents;
  • medication review and treatment adjustment;
  • medical advice while travelling or living abroad;
  • second opinions and guidance on whether in-person care is needed.
Dr Cichi’s consultations are structured and practical. He focuses on clear explanations, risk assessment, and actionable recommendations, helping patients understand their symptoms and make informed decisions about their health.
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Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Doctor

Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

  • Respiratory conditions: colds, flu, acute and chronic bronchitis, mild to moderate pneumonia, bronchial asthma.
  • ENT and eye conditions: sinusitis, tonsillitis, pharyngitis, otitis, infectious and allergic conjunctivitis.
  • Digestive issues: gastritis, acid reflux (GERD), IBS, dyspepsia, bloating, constipation, diarrhoea, functional bowel symptoms, intestinal infections.
  • Urological and infectious diseases: acute and recurrent cystitis, bladder and kidney infections, prevention of recurrent UTIs, asymptomatic bacteriuria.
  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
  • Neurological and general symptoms: headache, migraine, dizziness, fatigue, sleep disturbances, reduced concentration, anxiety, asthenia.
  • Chronic pain support: back, neck, joint, and muscle pain, tension syndromes, pain associated with osteochondrosis and chronic conditions.

Additional care areas:

  • Preventive consultations and check-up planning.
  • Medical advice and follow-up consultations.
  • Test interpretation and diagnostic guidance.
  • Structured support for undiagnosed complaints.
  • Second opinion on diagnoses and treatment plans.
  • Nutritional and lifestyle support for vitamin deficiencies, anaemia, metabolic issues.
  • Post-operative recovery support and pain management.
  • Preconception counselling and postpartum support.
  • Immunity support and strategies to reduce frequency of infections.

Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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€70
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Doctor

Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

  • Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs.
  • ENT conditions: sinusitis, tonsillitis, otitis (ear infections), sore throat, allergic rhinitis.
  • Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation.
  • Digestive issues: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), constipation, bloating, nausea.
  • Urinary and reproductive health: urinary tract infections (UTIs), cystitis, prevention of recurrent infections.
  • Chronic diseases: hypertension, elevated cholesterol, weight management.
  • Neurological complaints: headaches, migraines, sleep disturbances, fatigue, general weakness.
  • Children’s health: fever, infections, digestive issues, follow-ups, vaccination guidance.

She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
  • Personalised preventive care and wellness consultations.
  • Interpretation of test results and medical reports.
  • Follow-up care and medication review.
  • Support in managing multiple coexisting conditions.
  • Remote prescription management and medical documentation.

Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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€55

Frequently Asked Questions

Is a prescription required for SODIUM COLISTIMETHATE ACCORD 1 Million IU POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION?
SODIUM COLISTIMETHATE ACCORD 1 Million IU POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in SODIUM COLISTIMETHATE ACCORD 1 Million IU POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION?
The active ingredient in SODIUM COLISTIMETHATE ACCORD 1 Million IU POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION is colistin. This information helps identify medicines with the same composition but different brand names.
Who manufactures SODIUM COLISTIMETHATE ACCORD 1 Million IU POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION?
SODIUM COLISTIMETHATE ACCORD 1 Million IU POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION is manufactured by Accord Healthcare S.L.U.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of SODIUM COLISTIMETHATE ACCORD 1 Million IU POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether SODIUM COLISTIMETHATE ACCORD 1 Million IU POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to SODIUM COLISTIMETHATE ACCORD 1 Million IU POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION?
Other medicines with the same active substance (colistin) include COLFINAIR 1 Million IU Powder for Solution for Nebulizer Inhalation, COLFINAIR 2 MILLION IU POWDER FOR SOLUTION FOR NEBULIZER INHALATION, SODIUM COLISTIMETHATE ACCORD 2 Million IU POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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