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SODIUM COLISTIMETHATE ALTAN PHARMA 2 Million IU POWDER FOR INJECTION AND INFUSION SOLUTION

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About the medicine

How to use SODIUM COLISTIMETHATE ALTAN PHARMA 2 Million IU POWDER FOR INJECTION AND INFUSION SOLUTION

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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 Altan Pharma 2 million IU powder for solution for injection and infusion

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 experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Sodium Colistimethate Altan Pharma is and what it is used for

This medicine is an antibiotic belonging to the group of polymyxins.

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

It is essential that you follow the instructions regarding dosage, administration interval, and treatment duration as indicated by your doctor.

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

Sodium Colistimethate Altan Pharma is an antibiotic that can be used:

  • intravenously, administered through injection to treat certain severe infections caused by specific bacteria. Sodium Colistimethate Altan Pharma is used when other antibiotics are not suitable.
  • through inhalation, administered as an inhalation to treat chronic respiratory infections in patients with cystic fibrosis. Sodium Colistimethate Altan Pharma is used when these infections are caused by a specific bacterium called Pseudomonas aeruginosa.
Doctor consultation

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2. What you need to know before you use Sodium Colistimethate Altan Pharma

Do not use Sodium Colistimethate Altan Pharma:

  • 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 Altan Pharma

  • 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 via inhalation).

In premature infants and newborns, special caution should be exercised when using Sodium Colistimethate Altan Pharma because the kidneys are not yet fully developed.

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.

Using Sodium Colistimethate Altan Pharma with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Tell your doctor if you are using:

  • medicines that may affect how your kidneys work. Taking these medicines at the same time as Sodium Colistimethate Altan Pharma may increase the risk of kidney damage.
  • medicines that may affect the nervous system. Taking these medicines at the same time as Sodium Colistimethate Altan Pharma may increase the risk of adverse effects on your nervous system.
  • muscle relaxant medicines, often used during general anesthesia. Sodium Colistimethate Altan Pharma may increase the effects of these medicines. If you are going to be given a general anesthetic, inform your anesthetist that you are using Sodium Colistimethate Altan Pharma.

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 Sodium Colistimethate Altan Pharma increases the risk of muscle weakness and breathing difficulties.

Receiving Sodium Colistimethate Altan Pharma as an infusion at the same time as receiving Sodium Colistimethate Altan Pharma as an inhalation may increase your risk of experiencing 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 Altan Pharma should only be administered to pregnant patients if the expected benefit outweighs any potential risk.

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

Driving and using machines

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

Sodium Colistimethate Altan Pharma contains sodium

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

Medicine questions

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Discuss your symptoms and treatment with a doctor online.

3. How to use Sodium Colistimethate Altan Pharma

  • Intravenous route:

Your doctor has prescribed Sodium Colistimethate Altan Pharma as an infusion in a vein over 30 to 60 minutes.

The usual dose in adults is 9 million units, divided into two or three doses. If you are severely ill, you may be given a higher dose of 9 million units once 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 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 administered occasionally.

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 Sodium Colistimethate Altan Pharma.

  • Inhalation route:

The usual dose in adults, adolescents, and children over 2 years of age 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 of age 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 Altan Pharma than you should

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

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 forget to use Sodium Colistimethate Altan Pharma

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

If you are receiving this medicine intravenously and it has been less than 3 hours since you were supposed to receive your dose, you can ask for the dose to be administered. If more than 3 hours have passed since the forgotten dose, wait until the next administration.

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

If you stop using Sodium Colistimethate Altan Pharma

Your doctor will indicate the duration of treatment with Sodium Colistimethate Altan Pharma. Do not stop treatment before, 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 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 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 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:

System Organ Class

Frequency

Adverse Reaction

Nervous system disorders

Very common

Numbness or tingling around the lips and face.Headache.

Not known

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

Sodium Colistimethate Altan Pharma 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.

Not known

Allergic reactions such as skin rashes or swelling (of lips, mouth, throat). If this occurs, inform your doctor immediately because 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 condition known as pseudo-Bartter syndrome (see section 2):

  • Muscle spasms
  • Increased urine production
  • Fatigue

Possible side effects after inhalation:

System Organ Class

Frequency

Adverse Reaction

Respiratory, thoracic, and mediastinal disorders

Very common

Nebulization of this medicine through a nebulizer may cause cough and wheezing or shortness of breath.Difficulty breathing due to narrowing of the airways.

General disorders and administration site conditions

Not known

Allergic reactions such as skin rashes. If this occurs, inform your doctor immediately because it may be necessary to discontinue 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 they are 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 Altan Pharma

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

No special storage conditions are required.

Once reconstituted, this medicine should be used immediately.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sodium Colistimethate Altan Pharma

  • The active substance is sodium colistimethate. Each vial contains 2 million International Units (2 MIU) which is equivalent to approximately 160 mg of sodium colistimethate.

Appearance of the product and pack contents

Powder for solution for injection and infusion.

White powder.

Each pack contains 10 vials. The vials are made of type I glass, with a bromobutyl stopper and an aluminum flip-off cap.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Altan Pharmaceuticals S.A.

C/ Cólquide 6, Portal 2, 1ª planta, Oficina F, Edificio Prisma

28230 Las Rozas (Madrid)

Spain

Manufacturer

Altan Pharmaceuticals S.A.

Avda. de la Constitución 199, Polígono Industrial Monte Boyal

45950 Casarrubios del Monte (Toledo)

Spain

Date of last revision of this leaflet: June 2023

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

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This information is intended only for healthcare professionals:

Intravenous route

Injection

Reconstitute the contents of the vial with a maximum of 10 ml of water for injectable preparations or 0.9% sodium chloride.

Infusion

For administration by infusion of this medicine, the reconstituted vial should be diluted in a volume of 50 ml.

Compatible infusion solutions are: 0.9% sodium chloride.

For reconstitution, a 0.9% sodium chloride solution or water for injectable preparations can be used. The solution after reconstitution should be a clear and particle-free solution. If particles are observed in suspension, the solution should be discarded.

Sodium Colistimethate Altan Pharma solutions for parenteral administration should be prepared preferably at the time of administration. Reconstituted solutions should be administered immediately.

The solution is for single use and any unused solution should be discarded.

Inhalation use

Reconstitute the contents of the vial with water for injectable preparations to produce a hypotonic solution or with a 50:50 mixture of water for injectable preparations and 0.9% sodium chloride to produce an isotonic solution or with 0.9% sodium chloride to produce a hypertonic solution.

The volume of reconstitution will depend on the instructions for use of the nebulizer device, and normally does not exceed 4 ml.

The solution after reconstitution should be a clear and particle-free solution. If particles are observed in suspension, the solution should be discarded.

Solutions for nebulization reconstituted with water for injectable preparations should be administered immediately. Solutions for nebulization reconstituted with 0.9% sodium chloride or with a 50:50 mixture of water for injectable preparations and 0.9% sodium chloride are chemically and physically stable in the original vial for 24 hours at 2°C – 8°C.

Once reconstituted, Sodium Colistimethate Altan Pharma can be used with any conventional nebulizer suitable for the administration of antibiotic solutions.

The solution is for single use and any unused solution should be discarded.

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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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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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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.
  • 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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Frequently Asked Questions

Is a prescription required for SODIUM COLISTIMETHATE ALTAN PHARMA 2 Million IU POWDER FOR INJECTION AND INFUSION SOLUTION?
SODIUM COLISTIMETHATE ALTAN PHARMA 2 Million IU POWDER FOR INJECTION AND INFUSION SOLUTION 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 ALTAN PHARMA 2 Million IU POWDER FOR INJECTION AND INFUSION SOLUTION?
The active ingredient in SODIUM COLISTIMETHATE ALTAN PHARMA 2 Million IU POWDER FOR INJECTION AND INFUSION SOLUTION is colistin. This information helps identify medicines with the same composition but different brand names.
Who manufactures SODIUM COLISTIMETHATE ALTAN PHARMA 2 Million IU POWDER FOR INJECTION AND INFUSION SOLUTION?
SODIUM COLISTIMETHATE ALTAN PHARMA 2 Million IU POWDER FOR INJECTION AND INFUSION SOLUTION is manufactured by Altan Pharmaceuticals Sa. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of SODIUM COLISTIMETHATE ALTAN PHARMA 2 Million IU POWDER FOR INJECTION AND INFUSION SOLUTION 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 ALTAN PHARMA 2 Million IU POWDER FOR INJECTION AND INFUSION SOLUTION 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 ALTAN PHARMA 2 Million IU POWDER FOR INJECTION AND INFUSION SOLUTION?
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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