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SODIUM COLISTIMETHATE ACCORDPHARMA 2 Million IU POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

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About the medicine

How to use SODIUM COLISTIMETHATE ACCORDPHARMA 2 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

Colistimethate Sodium Accordpharma 2 Million IU Powder for Solution for Injection and 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.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • 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 Package Leaflet

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

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

Colistimethate Sodium Accordpharma contains the active substance colistimethate sodium. Colistimethate sodium is an antibiotic belonging to the group of polymyxins.

Text about the use of antibiotics, dosing instructions, and safe disposal of leftover medication

Colistimethate sodium is administered by injection to treat certain severe infections caused by specific bacteria.

Colistimethate sodium is used when other antibiotics are not suitable.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you use Colistimethate Sodium Accordpharma

Do not use Colistimethate Sodium Accordpharma

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

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use this medicine

  • If you have or have had kidney problems
  • If you have myasthenia gravis
  • If you have porphyria
  • 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.

Children

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

Other Medicines and Colistimethate Sodium Accordpharma

Tell 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.

Sometimes other medicines need to be stopped (even if only for a while) or you may need a lower dose of colistimethate sodium or need to be monitored while taking colistimethate sodium.

In some cases, it may be necessary to measure the level of colistimethate sodium in your blood from time to time to make sure you are taking the correct dose.

  • Medicines such as aminoglycoside antibiotics (including gentamicin, tobramycin, amikacin, and netilmicin) and cephalosporins may affect how your kidneys work. Taking these medicines at the same time as colistimethate sodium may increase the risk of kidney damage (see section 4 of the package leaflet).
  • Medicines such as aminoglycoside antibiotics (including gentamicin, tobramycin, amikacin, and netilmicin) may affect the nervous system. Taking these medicines at the same time as colistimethate sodium may increase the risk of adverse effects on the ears or other parts of your nervous system (see section 4 of the package leaflet).
  • Medicines called muscle relaxants, used often during general anesthesia. Colistimethate sodium may increase the effects of these medicines. If you are going to be given a general anesthetic, tell your anesthetist 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 medicine increases the risk of muscle weakness and breathing difficulties even more.

Pregnancy and Breastfeeding

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.

Pregnancy

There are no adequate data on the use of this medicine in pregnant women. Your doctor should only give you this medicine if the expected benefit outweighs any potential risk to the fetus.

Breastfeeding

Small amounts of colistimethate sodium may pass into breast milk. Breastfeeding is not recommended during treatment with this medicine.

Driving and Using Machines

When colistimethate sodium is administered intravenously, it may cause dizziness, confusion, or visual problems. If this occurs, you should not drive or use machinery.

Colistimethate Sodium Accordpharma contains Sodium

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

3. How to use Colistimethate Sodium Accordpharma

Depending on the reason (see section 1 of the package leaflet), this medicine may be administered as a rapid injection (over 5 minutes into a vein through a special tube) or as a slow injection (infusion over 30 to 60 minutes) into a vein. Sometimes, colistimethate sodium may be administered as an injection into the brain or spinal cord.

Follow your doctor's or pharmacist's instructions for administering this medicine exactly. If you are unsure, consult your doctor or pharmacist again.

Use for Infusion or Injection

The usual daily dose in adults is 9 million units, divided into two or three doses. If you are very ill, you may be given a higher dose of 9 million units at the start 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 who weigh up to 40 kg is 75,000 to 150,000 units per kilogram of body weight, divided into three doses.

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 colistimethate sodium.

Method of Administration

Colistimethate sodium is administered as an injection, mainly in hospitals. Your doctor will administer colistimethate sodium as an infusion into a vein over 30 to 60 minutes. If you need to treat yourself 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 decide the duration of treatment based on the severity of the infection. When treating bacterial infections, it is essential to complete the treatment to avoid worsening the existing infection.

If you use more Colistimethate Sodium Accordpharma than you should

If you think you have been given too much colistimethate sodium, contact your doctor or nurse immediately for advice, or if they are not available, contact or go to the emergency department of the nearest hospital.

If colistimethate sodium is accidentally given in excess, the side effects can be severe and may include kidney problems, muscle weakness, and difficulty breathing (or even respiratory arrest).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 5620420, indicating the medicine and the amount ingested.

If you are being treated in the hospital or at home by a doctor or nurse and think you may have missed a dose or been given too much colistimethate sodium, consult your doctor, nurse, or pharmacist about this.

If you forget to use Colistimethate Sodium Accordpharma

If you are treating yourself and forget a dose, you should administer the missed dose as soon as you remember and administer the next dose 8 hours later if you use colistimethate sodium three times a day, or 12 hours later if you use colistimethate sodium twice a day. From then on, follow the instructions. Do not take a double dose to make up for the missed dose.

If you stop using Colistimethate Sodium Accordpharma

Do not stop treatment before unless your doctor tells you to. Your doctor will tell you how long to use the treatment.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

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4. Possible Side Effects

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

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

  • muscle spasms
  • increased urine production
  • fatigue

Allergic Reactions

If colistimethate sodium is administered into a vein, an allergic reaction may occur. Severe allergic reactions can occur even with the first dose and may include rapid onset of rash, swelling of the face, tongue, and throat, difficulty breathing due to constriction of the airways, and loss of consciousness.

If you experience signs of an allergic reaction, seek urgent medical attention.

Less severe allergic reactions include rash that may occur later during treatment.

Side Effects Associated with Intravenous Injection of Colistimethate Sodium

Side effects affecting the nervous system are more likely if the dose of colistimethate sodium is too high, in people with kidney problems, or in people using muscle relaxants or other medicines that affect the nerves in a similar way.

The most serious of these nervous system side effects is the inability to breathe due to paralysis of the chest muscles. If you experience any breathing difficulties, seek urgent medical help.

Other possible side effects are numbness or tingling (especially around the face), dizziness or loss of balance, rapid changes in blood pressure or blood flow (such as fainting and flushing), difficulty speaking, vision problems, confusion, and mental problems (such as loss of sense of reality). There may be reactions at the injection site, such as irritation.

Kidney problems may also occur. These are especially likely in people who already have weak kidneys, or who are given colistimethate sodium at the same time as other medicines that may affect the kidneys, or who are given too high a dose.

These kidney problems usually improve if treatment is stopped or the dose of colistimethate sodium is reduced.

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http://www.aemps.es/.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Colistimethate Sodium Accordpharma

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 label and carton after "EXP". The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

The diluted solutions of this medicine should be used immediately, or within 24 hours if stored in the refrigerator (between 2°C and 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 appearance of the solution should be a clear, colorless to pale yellow solution without visible particles.

Any remaining solution should be discarded.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

Composition of Colistimethate Sodium Accordpharma

The active substance is colistimethate sodium.

Each vial contains 2 million international units (IU) of colistimethate sodium.

There are no other ingredients.

Appearance of the Product and Pack Size

Colistimethate Sodium Accordpharma 2 million IU is a white lyophilized powder available in a 10 ml glass vial.

Pack sizes:

1 x 1 vial

1 x 10 vials

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Accord Healthcare, S.L.U.

Moll de Barcelona s/n,

World Trade Center Edifici Est 6ªplanta

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

This medicine is authorized in the Member States of the European Economic Area under the following names:

Member State

Medicine Name

Austria

Colistimethat-Natrium Accord 2 Mio. I.E. Pulver zur Herstellung einer Injektions-/Infusionslösung

Belgium

NL: Colistimethaat Accord 2 miljoen Internationale Eenheden (IE) poeder voor oplossing voor injectie/infusie

FR: Colistimethaat Accord 2 millions (UI) poudre pour solution injectable/pour perfusion

DE: Colistimethaat Accord 2 Millionen (IE) Pulver zur Herstellung einer Injektions-/Infusionslösung

Germany

Colistimethat-Natrium Accord 2 Millionen I.E. Pulver zur Herstellung einer Injektions-/Infusionslösung

Croatia

Kolistimetatnatrij Accord 2 milijuna IU prašak za otopinu za injekciju/infuziju

France

COLISTIMETHATE SODIQUE ACCORD 2 000 000 UI, poudre pour solution injectable/pour perfusion

Spain

Colistimetato de sodio Accordpharma 2 millones de UI polvo para solución inyectable y para perfusión EFG

Italy

Colistimetato sodico Accordpharma

Date of Last Revision of this Package Leaflet: February 2024

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

This information is intended only 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 sodium chloride 0.9%.

For infusion:

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

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

Disposal of unused medicine and all materials that have come into contact with it should be carried out in accordance with local regulations.

The solution after reconstitution should be a clear, colorless to pale yellow solution without visible particles.

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

Online doctors for SODIUM COLISTIMETHATE ACCORDPHARMA 2 Million IU POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

Discuss questions about SODIUM COLISTIMETHATE ACCORDPHARMA 2 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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Doctor

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;
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  • 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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Doctor

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.
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  • Preconception counselling and postpartum support.
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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.
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  • Digestive issues: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), constipation, bloating, nausea.
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  • 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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Frequently Asked Questions

Is a prescription required for SODIUM COLISTIMETHATE ACCORDPHARMA 2 Million IU POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION?
SODIUM COLISTIMETHATE ACCORDPHARMA 2 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 ACCORDPHARMA 2 Million IU POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION?
The active ingredient in SODIUM COLISTIMETHATE ACCORDPHARMA 2 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 ACCORDPHARMA 2 Million IU POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION?
SODIUM COLISTIMETHATE ACCORDPHARMA 2 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 ACCORDPHARMA 2 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 ACCORDPHARMA 2 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 ACCORDPHARMA 2 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 1 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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