Cloxacillin Normon 500 mg powder for injection and for infusion EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Cloxacilina Normon 500 mg powder for injectable solution and for infusion EFG
cloxacillin sodium
Read the entire leaflet carefully before you start using the medicine, as it contains important information for you.
even if they have the same symptoms as you, because it may harm them.
adverse effects are not listed in this leaflet. See section 4. |
Package leaflet:
- What Cloxacilina Normon is and what it is used for
- What you need to know before taking Cloxacilina Normon
- How to use Cloxacilina Normon
- Possible side effects
- How to store Cloxacilina Normon
- Contents of the pack and other information
1. What Cloxacilina Normon is and what it is used for
Cloxacilina Normon 500 mg is supplied as a vial containing powder for injectable solution.
Cloxacilina Normon is indicated for the treatment of the following infections caused by susceptible organisms:
- Skin and soft tissue infections.
- Mastitis (inflammation of the mammary gland).
- Osteoarticular infections such as septic arthritis (joint inflammation due to infection) and osteomyelitis (bone inflammation due to infection).
- Sepsis (systemic infection).
- Endocarditis (inflammation of certain parts of the heart).
- Meningitis (inflammation of the meninges).
2. What you need to know before starting to take Cloxacilina Normon
Do not use Cloxacilina Normon
If you are allergic (hypersensitive) to penicillins or other beta-lactams or to any of the other components of Cloxacilina Normon.
Warnings and precautions
- If you are allergic to cephalosporins, because cross-allergic reactions may occur.
- In newborns with jaundice (evidenced by yellowing of the skin).
- If you have renal dysfunction (kidney damage), due to the risk of neurotoxicity (damage to the nervous system).
- If you are on a restricted sodium intake, as each gram of Cloxacilina Normon 500 mg powder and solvent for injectable solution contains 50 mg of sodium.
This medicine may interfere with the analytical determination of serum aspartate aminotransferase (AST) concentration, urinary glucose testing, urinary and plasma protein determination, and Coombs test.
Other medicines and Cloxacilina Normon
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Some medicines may influence the action of others.
Cloxacilina Normon interacts with the following medicines:
- Bacteriostatic antibiotics (chloramphenicol, tetracyclines, erythromycin, or sulfonamides): may reduce its effect.
- Probenecid: reduces the elimination of cloxacillin.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before using any medicine.
Pregnancy
The use of Cloxacilina Normon in pregnant women should only be considered when the potential benefits outweigh the potential risks associated with treatment.
Breastfeeding
Cloxacilina Normon is excreted in breast milk. Its use during breastfeeding should be carried out with caution.
Driving and using machines
There is no evidence of effects on the ability to drive vehicles or operate dangerous machinery.
Important information about some of the components of Cloxacilina Normon
This medicine contains 26.4 mg of sodium (main component of table/cooking salt) per vial. This corresponds to 1.35% of the maximum daily recommended sodium intake for an adult.
3. How to use Cloxacilina Normon
Follow exactly the administration instructions for Cloxacilina Normon provided by your doctor. Consult your doctor, pharmacist, or nurse if you have any doubts.
Remember to take your medication as prescribed. Your doctor will indicate the duration of your treatment with cloxacilin. Do not stop treatment prematurely. If you feel that the effect of this medicine is too strong or too weak, inform your doctor, pharmacist, or nurse.
Cloxacilina Normon is administered by intravenous or intramuscular route.
The appropriate dosage for each type of pathology will be determined by your doctor.
Adults and children over 12 years of age: the recommended dose for adults is 500 mg to 1 g every 6–8 hours. These doses are indicative and may be increased if the severity of the condition so requires.
Children over 2 years of age: the recommended dose is 12.5–25 mg/kg body weight every 6–8 hours.
Children under 2 years of age: the recommended dose is 6.25–12.5 mg/kg body weight every 6 hours.
If you use more Cloxacilina Normon than you should
Contact your doctor or pharmacist immediately. In case of overdose or accidental ingestion, contact the Toxicology Information Service (Tel. 91 562 04 20), stating the product and the amount administered.
If you forget to take Cloxacilina Normon
Do not take a double dose to make up for missed doses.
If you interrupt treatment with Cloxacilina Normon
If you have any further questions about the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, Cloxacilina Normon may produce adverse effects, although not everyone experiences them:
- Hypersensitivity reactions: skin reactions, interstitial nephritis (inflammation of the kidney). Rarely, other reactions have been reported such as angioneuritic edema (extensive swelling of the face), anaphylaxis (an unusual or exaggerated allergic reaction leading to hypotension and bronchospasm that makes breathing difficult), serum sickness (an allergic reaction to serum).
- Gastrointestinal tract disturbances: diarrhea, nausea, and vomiting, which are usually mild and transient and do not require discontinuation of treatment. Persistent diarrhea should raise suspicion of pseudomembranous colitis.
- Blood disorders: rare cases of neutropenia (reduction in white blood cells) and platelet dysfunction have been reported.
- Central nervous system disturbances: at very high doses, seizures may occur. Liver function abnormalities: jaundice (yellowing of the skin) and hepatitis. Local reactions: cases of phlebitis (vein inflammation) may occur.
- Other adverse reactions: oral candidiasis.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Cloxacilina Normon
Keep this medicine out of the sight and reach of children. Store in the original packaging.
Do not use Cloxacilina Normon after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.
After reconstitution, the physicochemical stability of the product reconstituted with water for injections has been demonstrated for up to 6 hours at 25°C and 72 hours at 2-8°C. The physicochemical stability in use of the solution diluted with sodium chloride 9 mg/ml (0.9%) for injection or glucose 50 mg/ml (5%) in infusion bags or bottles has been demonstrated for 6 hours at 25°C or 48 hours at 2-8°C. From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2-8°C, unless the dilution/reconstitution was carried out under controlled and validated aseptic conditions.
Do not use this medicine if you observe the presence of particles or if the reconstituted solution is cloudy.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Package contents and other information
Composition of Cloxacilina Normon
The active substance is cloxacillin sodium. Each vial contains 500 mg of cloxacillin sodium.
Appearance of the product and contents of the pack
Cloxacilina Normon 500 mg is supplied as a powder for injectable solution, each pack containing one vial.
Marketing Authorization Holder and Manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)
OTHER PRESENTATIONS
Cloxacilina Normon 1 g powder for injectable solution and for infusion EFG.
Date of the most recent review of this leaflet: February 2024
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
Information for the physician
In case of overdose, symptomatic and supportive treatment should be carried out. Peritoneal dialysis or hemodialysis are not effective.
Precautions for parenteral administration
Intravenous administration: Reconstitute the vial with 10 mL of water for injections. Inject slowly over 3–4 minutes.
For administration by continuous infusion, the reconstituted powder in 10 mL of water for injections should be withdrawn from the vial and added to a 100 mL bag of sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) for infusion in hospital settings.
Intramuscular administration: Reconstitute the vial with 3.5 mL of water for injections.
Cloxacillin sodium must not be used in solutions containing protein hydrolysates, lipid emulsions, amino acids, blood or serum. It is compatible, however, with most commonly used intravenous solutions (e.g., physiological saline or glucose solutions).
Mixing cloxacillin and aminoglycosides may lead to substantial mutual inactivation; therefore, they must not be mixed in the same container for administration.