Colistimethate sodium Altan Pharma 2 million IU powder for injection and for infusion
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Colistimetato de Sodio Altan Pharma is and what it is used for
- 2. What you need to know before starting to use Colistin sulfate sodium Altan Pharma
- Do not use Colistimetate Sodium Altan Pharma:
- 3. How to use Colistimethate sodium Altan Pharma
- 4. Possible adverse effects
- 5. Storage of Colistimethate Sodium Altan Pharma.
- 6. Contents of the pack and other information
- Composition of Colistimethate Sodium from Altan Pharma
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Colistimethate Sodium Altan Pharma 2 million IU powder for injectable solution and for infusion
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, ask your doctor, pharmacist or nurse.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Colistimethate Sodium Altan Pharma is and what it is used for
- What you need to know before using Colistimethate Sodium Altan Pharma
- How to use Colistimethate Sodium Altan Pharma
- Possible adverse effects
- How to store Colistimethate Sodium Altan Pharma
- Contents of the pack and other information
1. What Colistimetato de Sodio Altan Pharma is and what it is used for
This medicine 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 the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.
Do not store or reuse this medicine. If you have any antibiotic left after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.
Colistimetato de Sodio Altan Pharma is an antibiotic that can be used:
-
intravenously, administered by injection to treat certain types of serious infections caused by specific bacteria. Colistimetato de Sodio Altan Pharma is used when other antibiotics are not suitable.
-
by inhalation, administered as an inhalation to treat chronic respiratory infections in patients with cystic fibrosis. Colistimetato de Sodio Altan Pharma is used when these infections are caused by a specific bacterium called Pseudomonas aeruginosa.
2. What you need to know before starting to use Colistin sulfate sodium Altan Pharma
Do not use Colistimetate Sodium Altan Pharma:
- If you are allergic (hypersensitive) to colistimetate sodium, colistin, or other polymyxins.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting treatment with Colistimetate Sodium Altan Pharma
- If you have or have had kidney problems.
- If you have myasthenia gravis.
- If you have porphyria.
- If you have asthma (with inhaled use).
Special caution should be taken when using Colistimetate Sodium Altan Pharma in premature infants and newborns, as their 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 symptoms may be related to a condition known as pseudo-Bartter syndrome.
Use of Colistimetate Sodium Altan Pharma with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Tell your doctor if you are taking:
- Medicines that may affect how your kidneys function. Taking such medicines together with Colistimetate Sodium Altan Pharma may increase the risk of kidney damage.
- Medicines that may affect the nervous system. Taking such medicines together with Colistimetate Sodium Altan Pharma may increase the risk of adverse effects on your nervous system.
- Medicines known as muscle relaxants, often used during general anesthesia. Colistimetate Sodium Altan Pharma may enhance the effects of these medicines. If you are to receive general anesthesia, inform your anesthetist that you are using Colistimetate Sodium Altan Pharma.
If you have myasthenia gravis and are also taking other antibiotics known as macrolides (such as azithromycin, clarithromycin, or erythromycin), or antibiotics known as fluoroquinolones (such as ofloxacin, norfloxacin, and ciprofloxacin), taking Colistimetate Sodium Altan Pharma further increases the risk of muscle weakness and breathing difficulties.
Receiving Colistimetate Sodium Altan Pharma by infusion at the same time as receiving Colistimetate Sodium Altan Pharma by inhalation may increase your risk of adverse effects.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Colistimetate Sodium Altan Pharma should only be administered to pregnant patients if the expected benefit outweighs any potential risk.
Breastfeeding must be discontinued during treatment with Colistimetate Sodium Altan Pharma, as this medicine may pass into breast milk.
Driving and use of machines
Colistimetate Sodium Altan Pharma may cause dizziness, confusion, or visual disturbances; therefore, you should not drive or operate any tools or machinery in such cases.
Colistimetate Sodium Altan Pharma contains sodium
This medicine contains less than 23 mg (1 mmol) of sodium per dose, meaning it is essentially "sodium-free".
3. How to use Colistimethate sodium Altan Pharma
- Intravenous route:
Your doctor has prescribed Colistimethate sodium Altan Pharma 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 in poor clinical condition, you will 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, 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, usually receive lower doses.
Your doctor will monitor your kidney function regularly while you are receiving Colistimethate sodium Altan Pharma.
- Inhalation route:
The usual dose in adults, adolescents, and children aged 2 years and older is 1–2 million units two or three times a day (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 instruct you on the order in which they should be taken.
If you use more Colistimethate sodium Altan Pharma than you should
If you have used more Colistimethate sodium Altan Pharma than prescribed, 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 5620420, indicating the medication and the amount ingested.
If you forget to use Colistimethate sodium Altan Pharma
Do not administer a double dose to make up for a missed dose.
If you are receiving this medicine intravenously and no more than 3 hours have passed since the 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 scheduled time.
If the medicine is administered by inhalation, take the missed dose as soon as you remember, then continue with your next dose at the usual time.
If you stop treatment with Colistimethate sodium Altan Pharma
Your doctor will determine the duration of treatment with Colistimethate sodium Altan Pharma. 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 experiences them.
The observed adverse effects have been classified by organ systems and 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 available data).
In the case of sodium colistimethate, 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 following intravenous administration:
Organ System Classification | Frequency | Adverse Reaction |
Nervous system disorders | Very common | Tingling or numbness around the lips and face. Headache. |
Unknown | Difficulty speaking. Visual disturbances. Confusion. Mental disturbances or flushing (reddening 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 medications that may affect the kidneys (including increases in certain specific kidney function test results such as urea and creatinine). |
Rare | Renal failure. | |
General disorders and administration site conditions | Very common | Muscle weakness. Itching. |
Unknown | Allergic reactions such as skin rashes or swelling (of lips, mouth, throat). If this occurs, inform your doctor immediately, as it may be necessary to discontinue treatment. Pain at the injection site. |
After intravenous administration, you may experience the following symptoms, 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:
System Organ Class | Frequency | Adverse Reaction |
Respiratory, thoracic and mediastinal disorders | Very common | Nebulization of this medication through a nebulizer may cause coughing and, in some individuals, chest tightness, wheezing, or a sensation of suffocation. |
General disorders and administration site conditions | Not known | Allergic reactions such as skin rashes. If this occurs, inform your doctor immediately, as treatment may need to be discontinued. |
Reporting of adverse reactions
If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. Storage of Colistimethate Sodium 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. Doing so helps protect the environment.
6. Contents of the pack and other information
Composition of Colistimethate Sodium from Altan Pharma
- The active substance is sodium colistimethate. Each vial contains 2 million International Units (2 MIU), equivalent to approximately 160 mg of sodium colistimethate.
Appearance of the product and contents of the pack
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 rubber stopper and an aluminum flip-off cap.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Altan Pharmaceuticals S.A.
C/ Cólquide 6, Portal 2, 1st floor, Office 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 the most recent review of this summary: June 2023
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.
This information is intended for healthcare professionals only:
Intravenous use
Injection
Reconstitute the vial contents with up to 10 ml of water for injections or 0.9% sodium chloride solution.
Infusion
For infusion administration, the reconstituted vial must be further diluted in a volume of 50 ml.
Compatible infusion solutions: 0.9% sodium chloride solution.
For reconstitution, either 0.9% sodium chloride solution or water for injections may be used. The solution after reconstitution must be clear and free from suspended particles. If particles are observed, the solution must be discarded.
Solutions of Colistimethate Sodium from Altan Pharma for parenteral administration should preferably be prepared at the time of use. Reconstituted solutions must be administered immediately.
The solution is for single use only, and any unused portion must be discarded.
Inhalation use
Reconstitute the vial contents either with water for injections to produce a hypotonic solution, or with a 50:50 mixture of water for injections and 0.9% sodium chloride solution to produce an isotonic solution, or with 0.9% sodium chloride solution to produce a hypertonic solution.
The reconstitution volume should be based on the instructions for use of the nebulizer device and normally does not exceed 4 ml.
The solution after reconstitution must be clear and free from suspended particles. If particles are observed, the solution must be discarded.
Solutions for nebulization reconstituted with water for injections must be administered immediately. Solutions for nebulization reconstituted with 0.9% sodium chloride solution or with a 50:50 mixture of water for injections and 0.9% sodium chloride solution are chemically and physically stable in the original vial for 24 hours at 2°C–8°C.
Once reconstituted, Colistimethate Sodium from Altan Pharma can be used with any conventional nebulizer suitable for the administration of antibiotic solutions.
The solution is for single use only, and any unused portion must be discarded.