This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use CEFOXITINE NORMON 1 g powder and solvent for injectable solution and for infusion

Introduction

Package Leaflet: Information for the User

Cefoxitin NORMON 1 g Powder and Solvent for Solution for Injection and Infusion EFG

Cefoxitin (as cefoxitin sodium)

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 or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

What is Cefoxitin NORMON and what is it used for
What you need to know before you use Cefoxitin NORMON
How to use Cefoxitin NORMON
Possible side effects
Storage of Cefoxitin NORMON
Contents of the pack and further information

1. What is Cefoxitin NORMON and what is it used for

Cefoxitin belongs to a group of antibiotics known as cephalosporins.

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

It is important 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 finishing the treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

It is indicated for the treatment of infections caused by microorganisms sensitive to cefoxitin, located in the respiratory, urinary, and genital tracts, abdomen, blood (septicemia), bones and joints, skin and soft tissues, burns, or infected wounds, as well as for the prevention of infections in surgery.

2. What you need to know before you use Cefoxitin NORMON

Do not use Cefoxitin NORMON

If you are allergic (hypersensitive) to cefoxitin or other cephalosporins or any of the other components of this medicine (listed in section 6).

Be cautious with Cefoxitin NORMON

If you are allergic to beta-lactam antibiotics (such as penicillin), cross-allergy may occur.
If you experience diarrhea while receiving treatment with cefoxitin, as it may be due to a special type of colitis called pseudomembranous colitis (inflammation of the large intestine), which can be severe. In these cases, your doctor will decide whether to suspend cefoxitin administration and initiate appropriate treatment.
If you have kidney disease, your doctor may need to adjust the dose of cefoxitin you receive.
If you are on a low-salt diet, as each gram of Cefoxitin NORMON contains 53.81 mg of sodium.
If you are undergoing prolonged treatment with cefoxitin, superinfections may occur.
If you are to undergo any blood tests, inform the healthcare staff that you are being treated with this medicine, as cefoxitin may interfere with the results.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Cefoxitin NORMON.

Using Cefoxitin NORMON with other medicines

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

Some medicines may influence the action of others.

Cefoxitin should not be administered simultaneously with aminoglycosides (other antibiotics).

In case of doubt, consult your doctor or pharmacist.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

In the case of pregnancy, your doctor will decide whether to use this medicine.

Breastfeeding

In the case of breastfeeding, your doctor will decide whether to use this medicine. Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Cefoxitin generally does not affect the ability to drive vehicles or operate machinery.

Cefoxitin NORMON contains sodium

This medicine contains 53.81 mg of sodium (2.34 mmol) (a major component of table salt/cooking salt) per gram. This is equivalent to 2.69% of the maximum recommended daily sodium intake for an adult.

3. How to use Cefoxitin NORMON

Follow exactly the administration instructions of this medicine as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Cefoxitin will be administered intravenously. Remember to use your medicine.

Your doctor will indicate the appropriate dose and duration of your treatment with cefoxitin. Do not suspend or prolong it, as the expected effect will not be achieved.

If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

The usual dose is:

Adults:uncomplicated infections: 1 g every 6-8 hours by intravenous injection. For moderately severe or severe infections, 1 g every 4 hours or 2 g every 6-8 hours by intravenous injection is recommended. In cases of life-threatening infections, 2 g every 4 hours or 3 g every 6 hours by intravenous injection may be administered.

A dose reduction may be necessary if you have kidney disease. In such cases, inform your doctor so that the dose can be adjusted accordingly.

Use in children

Children over 3 months:80-160 mg/kg body weight per day, divided into 4-6 equal doses. If you have kidney disease, your doctor may need to reduce the dose.

Cefoxitin is not recommended for use in children under 3 months.

Surgical prophylaxis

Cefoxitin administration should be performed between 30 and 60 minutes before surgery and discontinued within 24 hours thereafter. The following guidelines are recommended:

Adults: 2 g by intravenous injection 30 or 60 minutes before surgery, followed by 2 g every 6 hours.

Children (over 3 months): 30-40 mg/kg 30 or 60 minutes before surgery, followed by 2 g every 6 hours.

Patients undergoing cesarean section: a single dose of 2 g by intravenous injection may be administered at the time of umbilical cord clamping, or 3 doses of 2 g, with the first dose administered at the time of umbilical cord clamping and the next two doses administered 4 and 8 hours after the first dose, respectively.

If you use more Cefoxitin NORMON than you should

Consult your doctor or pharmacist immediately. In case of overdose or accidental administration/ingestion, consult the Toxicological Information Service (Tel. 91 562 04 20), indicating the product and the amount administered/ingested. Bring this leaflet with you.

Information for the doctor:In case of overdose, treatment will be symptomatic and according to medical criteria. Cefoxitin is eliminated by hemodialysis.

If you forget to use Cefoxitin NORMON

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people):

Allergic reactions:the most common is the appearance of skin lesions of various types. Other possible reactions are itching, swelling of the face, and difficulty breathing.
Gastrointestinal disorders:nausea, vomiting, and diarrhea.

Uncommon side effects (may affect up to 1 in 100 people):

Blood disorders:decreases in some blood cells, such as red and white blood cells, have been reported.

Rare side effects (may affect up to 1 in 1,000 people):

Liver disorders:rarely, transient increases in liver enzymes (transaminases) have been observed.
Kidney disorders:in some cases, increased creatinine levels in the blood have been observed, indicating poor kidney function.

Side effects of unknown frequency (cannot be estimated from the available data):

Cardiovascular disorders:hypotension (low blood pressure).

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cefoxitin NORMON

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

Do not store above 30°C.

Reconstituted solutions remain stable for 24 hours at room temperature and for 4 days at 8°C.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Cefoxitin NORMON:

The active substance is cefoxitin (sodium). Each vial contains 1 g of cefoxitin (sodium). Each ampoule of solvent contains water for injections.

Appearance of the product and pack contents

Cefoxitin NORMON 1 g powder and solvent for solution for injection and infusion EFG is presented in a vial with powder and solvent for solution for injection. Each pack contains a vial of cefoxitin powder and an ampoule with 10 ml of water for injection.

Once reconstituted with its solvent, the solution contains 100 mg of cefoxitin per ml.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

This information is intended for healthcare professionals only:

For intravenous administration, the contents of the vial are dissolved in the 10 ml of solvent from the accompanying ampoule (water for injections). It can be administered by slow intravenous injection over 3 to 5 minutes, after prior dilution in the solvent. For continuous intravenous infusion, the resulting solution can be further diluted in a standard infusion solution (5% glucose, 0.9% sodium chloride, 5% glucose, and 0.9% sodium chloride, or 5% glucose with the addition of 0.02% sodium bicarbonate).

It is not recommended to mix cefoxitin sodium with other medicines.

Date of last revision of this leaflet: July 2022

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

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

12+ years of clinical experience in university hospitals in Germany and Spain.
International education: Ukraine – Germany – Spain.
Member of the German Society of Surgeons (BDC).
Certified in radiological diagnostics and robotic surgery.
Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

CEFOXITINE NORMON 1 g powder and solvent for injectable solution and for infusion

Karim BenHarbi

Maryna Kuznetsova

Karim BenHarbi

Maryna Kuznetsova