Colistimethate sodium Altan Pharma 1 million IU powder for injection and for infusion
Spain
Table of Contents
- Patient Information Leaflet
- Introduction
- 1. What Colistimetate Sodium Altan Pharma is and what it is used for
- 2. What you need to know before using Colistimetatosodium 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 container and additional information
Patient Information Leaflet
Introduction
Patient Information Leaflet
Colistimethate Sodium Altan Pharma 1 million IU powder for solution for injection and infusion
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor, pharmacist, or nurse.
- If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Contents of the leaflet
- 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 side effects
- How to store Colistimethate Sodium Altan Pharma
- Contents of the pack and other information
1. What Colistimetate Sodium 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 your doctor's instructions regarding dose, frequency, and duration of treatment.
Do not store or reuse this medicine. If you have any antibiotic left over after finishing the treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.
Colistimetate Sodium Altan Pharma is an antibiotic that can be used:
-
By intravenous route. It is administered by injection to treat certain types of serious infections caused by specific bacteria. Colistimetate Sodium Altan Pharma is used when other antibiotics are not suitable.
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By inhalation route. It is administered as an inhalation to treat chronic respiratory infections in patients with cystic fibrosis. Colistimetate Sodium Altan Pharma is used when these infections are caused by a specific bacterium called Pseudomonas aeruginosa.
2. What you need to know before using Colistimetatosodium Altan Pharma
Do not use Colistimetatosodium Altan Pharma
If you are allergic (hypersensitive) to colistimetatosodium, colistin, or other polymyxins.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting treatment with Colistimetatosodium Altan Pharma
- If you have or have had kidney problems.
- If you have myasthenia gravis.
- If you have porphyria.
- If you have asthma (when used by inhalation route).
Special caution is required when using Colistimetatosodium 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 Colistimetatosodium 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 work. Taking such medicines together with Colistimetatosodium Altan Pharma may increase the risk of kidney damage.
- Medicines that may affect the nervous system. Taking such medicines together with Colistimetatosodium Altan Pharma may increase the risk of adverse effects on the nervous system.
- Medicines called muscle relaxants, often used during general anesthesia. Colistimetatosodium Altan Pharma may enhance the effects of these medicines. If you are to receive general anesthesia, inform your anesthetist that you are using Colistimetatosodium 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 Colistimetatosodium Altan Pharma may further increase the risk of muscle weakness and breathing difficulties.
Receiving Colistimetatosodium Altan Pharma by infusion at the same time as receiving Colistimetatosodium Altan Pharma by inhalation may increase your risk of adverse effects.
Pregnancy, breast-feeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Colistimetatosodium Altan Pharma should only be administered to pregnant patients if the expected benefit outweighs any potential risk.
Breast-feeding must be discontinued during treatment with Colistimetatosodium Altan Pharma, as this medicine may pass into breast milk.
Driving and using machines
Colistimetatosodium Altan Pharma may cause dizziness, confusion, or visual disturbances; therefore, you should not drive or operate any tools or machinery in such cases.
Colistimetatosodium Altan Pharma contains sodium
This medicine contains less than 23 mg (1 mmol) of sodium per dose, which is essentially “sodium-free.”
3. How to use Colistimethate Sodium Altan Pharma
- Intravenous use:
Your doctor has prescribed Colistimethate Sodium Altan Pharma as an intravenous infusion over 30 to 60 minutes.
The usual dose for adults is 9 million units, divided into two or three doses. If you are in poor clinical condition, you may receive an initial higher dose of 9 million units at the beginning of treatment.
In some cases, your doctor may decide to administer a higher daily dose of up to 12 million units.
The usual daily dose for 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 use:
The usual dose for 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 for 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 circumstances. If you are also taking other inhaled medications, your doctor will advise you on the order in which to administer them.
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 telephone number 91 562 04 20, stating the medication and the amount ingested.
If you forget to use Colistimethate Sodium Altan Pharma
Do not take a double dose to make up for a missed dose.
If you are receiving this medicine by intravenous route and less 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 until the next scheduled dose.
If the administration is by inhalation, take the missed dose as soon as you remember, and then continue with your next dose at the usual time.
If you stop using 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 will experience them.
The observed adverse effects have been classified by organ and system and by frequency using the following convention: very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people); uncommon (may affect up to 1 in 100 people); rare (may affect up to 1 in 1,000 people); very rare (may affect up to 1 in 10,000 people); frequency not known (cannot be estimated from the available data).
In the case of colistimethate sodium, these effects mainly involve 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. |
Unknown | Difficulty speaking. | |
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 increased levels in certain special kidney function tests, such as urea and creatinine). |
Rare | Renal failure. | |
General disorders and administration site conditions | Very common | Muscle weakness. |
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. |
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:
Organ System | 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 side effects
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 side effects, 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.
Store below 25°C.
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 refers to the last day of the month indicated.
Do not use this medicine if you notice any visible signs of deterioration.
Medicines must not be disposed of via wastewater or household waste. Doing so helps protect the environment.
6. Contents of the container and additional information
Composition of Colistimethate Sodium Altan Pharma
The active substance is colistimethate sodium. Each vial contains 1 Million International Units (1 MIU), equivalent to approximately 80 mg of colistimethate sodium.
Appearance of the product and contents of the container
Powder for injectable solution and for infusion.
White-colored powder.
Each pack contains 10 vials. The vials are made of type I glass, with a bromobutyl stopper and an aluminum flip-off seal.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder:
Altan Pharmaceuticals S.A.
C/ Cólquide, nº 6. Portal 2, 1st floor. Office F, Edificio Prisma
28230 - Las Rozas (Madrid) - Spain
Manufacturer:
Altan Pharmaceuticals S.A.
Avda. de la Constitución 198-199, Polígono Industrial Monte Boyal
45950 Casarrubios del Monte (Toledo) – Spain
Date of the most recent review of this summary: June 2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.
This information is intended for healthcare professionals only:
Intravenous route:
Injection
Reconstitute the contents of the vial 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. After reconstitution, the solution must be clear and free from suspended particles. If particles are observed, the solution must be discarded.
Solutions of Colistimethate Sodium Altan Pharma for parenteral administration should preferably be prepared at the time of administration and, from a microbiological standpoint, should be used immediately. The reconstituted solution must be administered immediately.
The solution is for single use only; any unused portion must be discarded.
Inhalation route:
Reconstitute the contents of the vial 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 follow the nebulizer device's instructions for use and normally does not exceed 4 ml.
After reconstitution, the solution must be clear and free from suspended particles. If suspended particles are observed, the solution must be discarded.
Once reconstituted, Colistimethate Sodium Altan Pharma can be used with any conventional nebulizer suitable for the administration of antibiotic solutions.
The solution is for single use only; any unused portion must be discarded.