Colistimetato de sodio altan pharma 2 millones de ui polvo para soluciÓn inyectable y para perfusiÓn
Introduction
Prospect: information for the user
Colistimethate sodium Altan Pharma 2 million IU powder for injectable solution and for infusion
Read this prospect carefully before starting to use this medication, because it contains important information for you.
-Keep this prospect, as you may need to read it again.
-If you have any questions, consult your doctor, pharmacist, or nurse.
-If you experience adverse effects, consult your doctor orpharmacist, even if they are not listed in this prospect. See section 4.
1.What isColistimethate sodium Altan Pharmaand for what it is used
2.What you need to know before starting to useColistimethate sodium Altan Pharma
3.How to useColistimethate sodium Altan Pharma
4.Possible adverse effects
5.Storage ofColistimethate sodium Altan Pharma
6.Contents of the package and additional information
1. What is Colistimete Sulfate Altan Pharma and for what it is used
This medication is an antibiotic belonging to the group of polymyxins.
Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or a cold.
It is essential to follow the instructions regarding the dose, administration interval, and treatment duration indicated by your doctor.
Do not store or reuse this medication. If you have leftover antibiotics after treatment, return them to the pharmacy for proper disposal. Do not dispose of medications through the drain or in the trash.
Colistimete Sulfate Altan Pharmais an antibiotic that can be used:
- intravenously, administered by injection to treat certain types of severe infections caused by specific bacteria. Colistimete Sulfate Altan Pharma is used when other antibiotics are not suitable.
- inhalationally, administered as an inhalation to treat chronic respiratory infections in patients with cystic fibrosis. Colistimete Sulfate Altan Pharma is used when such infections are caused by a specific bacteria calledPseudomonas aeruginosa.
2. What you need to know before starting to use Colistin sodium Altan Pharma
No use Colistimethate Sodium Altan Pharma:
-If you are allergic (hypersensitive)to colistimethate sodium, colistin, or otherpolymyxins.
Warnings and precautions
Consult your doctor,pharmacist or nurse before starting to use Colistimethate Sodium Altan Pharma
- If you have or have had kidney problems.
- If you have myasthenia gravis.
- If you have porphyria.
- If you have asthma (in inhalation use).
Special caution should be taken when using Colistimethate 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 episodes may be related to a condition known as pseudo-Bartter syndrome.
Use of Colistimethate Sodium Altan Pharma withother medications
Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.
Inform your doctor if you are using:
- medications that may affect how your kidneys function. Taking such medications at the same time as Colistimethate Sodium Altan Pharma may increase the risk of kidney damage.
- medications that may affect your nervous system. Taking such medications at the same time as Colistimethate Sodium Altan Pharma may increase the risk of adverse effects on your nervous system.
- medications called muscle relaxants, often used during general anesthesia. Colistimethate Sodium Altan Pharma may increase the effects of these medications. If you are to receive general anesthesia, inform your anesthesiologist that you are using Colistimethate Sodium 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 Colistimethate Sodium Altan Pharma increases the risk of muscle weakness and respiratory difficulties even further.
Receiving Colistimethate Sodium Altan Pharma as an infusion at the same time as receiving Colistimethate Sodium Altan Pharma as an inhalation may increase your risk of adverse effects.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, or think you may be pregnant, consultyour doctor or pharmacist before using this medication.
Colistimethate Sodium Altan Pharma should only be administered to pregnant patients if the expected benefit outweighs any potential risk.
Discontinue breastfeeding during treatment withColistimethate Sodium Altan Pharma, as this medication may pass into breast milk.
Driving and operating machinery
Colistimethate Sodium Altan Pharma may cause dizziness, confusion, or visual problems, so do not drive or use any hazardous tools or machinery in these cases.
Colistimethate Sodium Altan Pharmacontains sodium
This medication 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 Route:
Your doctor has prescribed Colistimethate sodium Altan Pharma as an infusion into 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 quite ill, you will be given a single 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 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 regularly monitor your renal function while you are receiving Colistimethate sodium Altan Pharma.
- Inhalation Route:
The usual dose in adults, adolescents, and children 2 years of age or older is 1-2 million units two to 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, two times a day (up to 2 million units per day).
Your doctor may adjust the dose based on your circumstances. If you are also taking other inhaled medications, your doctor will instruct you on the order in which to take them.
If you use more Colistimethate sodium Altan Pharma than you should
If you have used more Colistimethate sodium Altan Pharma than you should, you may experience breathing difficulties, muscle weakness, and kidney function 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 medication and the amount ingested.
If you forgot to use Colistimethate sodium Altan Pharma
Do not administer a double dose to compensate for the missed doses.
If you are receiving this medication intravenously and it has not been more than 3 hours since you should have received your dose, you can request that the dose be administered to you. If more than 3 hours have passed since the missed dose, wait until the next scheduled 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 interrupt treatment withColistimethate sodium Altan Pharma
Your doctor will inform you of the duration of treatment with Colistimethate sodium Altan Pharma. Do not discontinue treatment prematurely, as there is a risk of the infection recurring.
If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.
4. Possible Adverse Effects
The observed side effects 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 available data).
In the case of colistimethate sodium, these affect mainly the nervous system and kidney function. The most common side effects after nebulization are cough and difficulty breathing.
Side effects possible after intravenous administration:
Organ System Classification | Frequency | Adverse Reaction |
Nervous system disorders | Very common | Tickling or numbness around the lips and face. Headache. |
Not known | Difficulty speaking. Visual disturbances. Confusion. Mental or flush (redness of the face) disturbances. Psychosis. Dizziness. Vertigo. Difficulty controlling movements. | |
Renal and urinary disorders | Very common | Colistimethate sodium Altan Pharma may affect the kidney, especially if the dose is high or you are taking another medicine that may affect the kidney (including increased certain kidney function test results, such as urea and creatinine). |
Rare | Renal 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 as 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 known disease called pseudo-Bartter syndrome (see section 2):
- muscle spasms
- increased urine production
- fatigue
Side effects possible after inhalation administration:
Organ System Classification | Frequency | Adverse Reaction |
Respiratory, thoracic and mediastinal disorders | Very common | The nebulization of this medicine through a nebulizer may produce cough and cause some people to experience chest tightness, wheezing or a sensation of choking. 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 as it may be necessary to discontinue treatment. Sore throat and mouth irritation that may be due to an allergy to the medicine or an added fungal infection when this medicine is administered through a nebulizer. |
Reporting of side effects
If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of Colistimethate Sodium Altan Pharma.
Keepthis medicationout of the sight and reach of children.
Nospecial storage conditions are required.
Once reconstituted, this medication must be used immediately.
Do not usethis medicationafter the expiration date shown on the packagingafter CAD. The expiration date is the last day of the month indicated.
Do not use this medication if you observe any visible sign of deterioration.
Medications should not be disposed of through drains or in the trash. This will help protect the environment.
6. Contents of the packaging and additional information
Composition of Colistimethate Altan Pharma
-The active ingredient is colistimethate sodium. Each vial contains 2 million International Units (2 MUI) which is approximately equivalent to 160 mg of colistimethate sodium.
Appearance of the product and contents of the package
Powderforinjection solution and for infusion.
White powder.
Each package contains 10 vials. The vials are type I glass, with bromobutyl stopper and aluminum flip-off cap.
Holder of the marketing authorization and responsible for manufacturing
Holder of the Marketing Authorization
Altan Pharmaceuticals S.A.
C/ Cólquide 6, Portal 2, 1st floor, Office F, Edificio Prisma
28230 Las Rozas (Madrid)
Spain
Responsible for manufacturing
Altan Pharmaceuticals S.A.
Avda. de la Constitución 199, Polígono Industrial Monte Boyal
45950 Casarrubios del Monte (Toledo)
Spain
Last review date of thisleaflet: June 2023
The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.
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This information is intended solely for healthcare professionals:
Intravenous administration
Injection
Reconstitute the contents of the vial with a maximum of 10 ml of water for injection or sodium chloride 0.9% solution.
Infusion
For administration by infusion of this medicine, the reconstituted vial should be diluted in a volume of 50 ml.
Compatible infusion solutions are: sodium chloride 0.9% solution.
For reconstitution, a sodium chloride 0.9% solution or water for injection may be used. The solution after reconstitution should be a clear and particle-free solution. In case of particles in suspension, the solution should be discarded.
The parenteral solutions of Colistimethate sodium Altan Pharma should be prepared preferably at the time of administration. The 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 injection to produce a hypotonic solution, or with a 50:50 mixture of water for injection and sodium chloride 0.9% solution to produce an isotonic solution, or with sodium chloride 0.9% solution to produce a hypertonic solution.
The reconstitution volume will depend on the instructions for use of the nebulizer administration device, and normally does not exceed 4 ml.
The solution after reconstitution should be a clear and particle-free solution. In case of particles in suspension, the solution should be discarded.
The nebulized solutions reconstituted with water for injection should be administered immediately. The nebulized solutions reconstituted with sodium chloride 0.9% solution or with a 50:50 mixture of water for injection and sodium chloride 0.9% solution are chemically and physically stable in the original vial for 24 hours at 2°C – 8°C.
When 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 and any unused solutionshould be discarded.
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