Cefoxitin LDP Laboratorios Torlan 2 g powder for injection and for infusion EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Cefoxitin LDP-Laboratorios TORLAN 1 g powder for injectable solution and for infusion EFG.

Cefoxitin LDP-Laboratorios TORLAN 2 g powder for injectable solution and for infusion EFG.

Cefoxitin Sodium

This medicinal product is subject to additional monitoring, which will allow for faster detection of new safety information. You can help by reporting any adverse reactions you may experience. Section 4 includes information on how to report adverse reactions.

Read this entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Package leaflet:

1. What Cefoxitina LDP-Laboratorios TORLAN is and what it is used for
2. What you need to know before using Cefoxitina LDP-Laboratorios TORLAN
3. How to use Cefoxitina LDP-Laboratorios TORLAN
4. Possible side effects
5. How to store Cefoxitina LDP-Laboratorios TORLAN
6. Contents of the pack and other information

1. What Cefoxitin LDP-Laboratorios TORLAN is and what it is used for

Cefoxitin is a beta-lactam antibiotic belonging to the second-generation cephalosporins group.

This medicinal product is indicated in adults and adolescents for the treatment of infections when it is known or suspected that they are caused by pathogens sensitive to cefoxitin.

Cefoxitin is indicated for:

• Complicated urinary tract infections.
• Pyelonephritis.

Cefoxitin may be notably useful in intra-abdominal infections and in certain gynecological infections.

2. What you need to know before starting to use Cefoxitina LDP-Laboratorios TORLAN.

Do not use Cefoxitina LDP-Laboratorios TORLAN.

• If you are allergic to cefoxitin, or to any other antibiotic in the cephalosporin group, or to any of the ingredients of this medicine (mentioned in section 6).
• If you have ever had a severe allergic reaction (hypersensitivity) (e.g., severe skin peeling; swelling of the face, hands, feet, lips, tongue, or throat; or difficulty swallowing or breathing) to any other type of beta-lactam antibiotic (penicillins, monobactams, and carbapenems).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Cefoxitina.

Allergic reactions

You must inform your doctor immediately if you experience any symptoms of an allergic reaction (rash, itching, etc.) during treatment. If a sudden, severe allergic reaction occurs, administration of Cefoxitina must be stopped. Before starting this treatment, inform your doctor if you have ever had hives or any other type of rash, itching, or Quincke's edema (sudden swelling of the face and neck due to an allergic reaction) during previous treatment with antibiotics.

Diarrhea

Diarrhea occurring during antibiotic treatment should not be treated without medical supervision. Diarrhea may occur while you are taking antibiotics, including cefoxitin, or after you have stopped taking them. If it becomes severe or persistent, or if you notice blood or mucus in your stools, contact your doctor immediately, as this may be life-threatening. Do not take medications that stop or slow intestinal movements.

If in doubt, consult your doctor or pharmacist.

Neurological disturbances

As with all antibiotics belonging to this therapeutic group, administration of this medicine may carry a risk of encephalopathy (which may lead to confusion, altered consciousness, seizures, abnormal movements), particularly in cases of overdose or renal insufficiency. If any of these symptoms occur, inform your doctor or pharmacist immediately (see sections 3 and 4).

Renal function

Inform your doctor if you have kidney disease, as your dose may need to be adjusted.

If you are taking other medicines that are harmful to the kidneys or if you are using diuretics, your doctor will monitor your kidney function.

Laboratory tests

Some laboratory test results may be altered during treatment with this medicine.

Other medicines and Cefoxitina

Inform your doctor if you are currently using, have recently used, or might use other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.

Pregnancy

Cefoxitin may be used during pregnancy only under medical supervision.

If you find out you are pregnant while taking Cefoxitin, consult your doctor, as only a healthcare professional can decide whether you should continue treatment.

Breastfeeding

Interrupt breastfeeding while using this medicine to avoid any allergic reaction in your baby.

Driving and using machines

Cefoxitin has a major influence on the ability to drive and use machines, particularly due to the possible occurrence of encephalopathy (see sections 3 and 4).

Cefoxitina LDP-Laboratorios TORLAN contains Sodium.

This medicine contains 50 mg of sodium (the main component of table/cooking salt) per gram. This is equivalent to 2.5% of the maximum recommended daily sodium intake for an adult. This should be taken into account if you are following a low-sodium controlled diet.

3. How to use Cefoxitin LDP-Laboratorios TORLAN

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.

The dose of this medicine depends on the type and severity of the infection. Your doctor will determine the appropriate dose and duration of treatment for you.

Adults and adolescents over 14 years of age:
The usual dose is 1 to 2 grams every 6 to 8 hours. In severe infections, doses up to 8 grams per day may be administered.

Children over 1 month of age:
The usual dose is 20 to 80 mg/kg body weight every 6 to 8 hours, depending on the type and severity of the infection.

Neonates (up to 1 month of age):
The usual dose is 40 mg/kg body weight every 12 hours.

Your doctor may adjust the dose in patients with severe renal impairment.

This medicine is administered by slow intravenous injection (over 3 to 5 minutes) or by intravenous infusion (over 30 to 60 minutes).

If you have used more Cefoxitin LDP-Laboratorios TORLAN than you should:
As with other cephalosporins, seizures may occur if excessive doses are administered, especially in patients with renal impairment.

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

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Your doctor or other healthcare professional will administer this medicine intravenously.

Dosing recommendation

Your doctor will decide the dose you need each day and how frequently the injections/infusions should be given per day.

The usual dose is:

Adults and adolescents: 2 g every 4–6 hours up to a maximum of 12 g/day

Patients with renal disease

If you have kidney problems, your doctor may adjust your dose.

Use in children

There are insufficient data to recommend a dosage regimen for children under 11 years of age.

How to use Cefoxitina LDP-Laboratorios TORLAN

Cefoxitin may be administered by slow intravenous injection over a period of 3 to 5 minutes.

It may also be given by continuous intravenous infusion of a solution of this medicine.

For instructions on reconstitution and dilution of the medicine prior to administration, refer to the information intended for healthcare professionals.

If you use more Cefoxitina LDP-Laboratorios TORLAN than you should

As with all antibiotics belonging to this therapeutic group, administration of the medicine may carry the risk of encephalopathy (which may lead to confusion, disturbances in consciousness, seizures, abnormal movements), particularly in cases of overdose or renal dysfunction. If any of these symptoms occur, consult your doctor or pharmacist immediately (see sections 2 and 4).

In case of overdose and/or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Cefoxitina LDP-Laboratorios TORLAN

Do not take a double dose to make up for a missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Frequency not known:

• Local reactions.
• Local inflammation of the vein with clot formation that may obstruct or prevent intravenous administration.
• Fever, allergic reactions, angioedema (sudden swelling of the face and neck caused by allergies), interstitial nephritis (kidney disease).
• Rash resembling hives (urticaria), itching, and rarely severe skin lesions.
• Nausea, vomiting, diarrhea, rare cases of pseudomembranous colitis (intestinal disease with diarrhea and abdominal pain) (see warnings and precautions).
• Blood abnormalities (eosinophilia, leukopenia, neutropenia, agranulocytosis, anemia, thrombocytopenia, bone marrow hypoplasia), characterized by an increase in certain blood components (eosinophils) or a decrease in certain blood components, possibly resulting in fever without apparent cause, nosebleeds or bleeding gums, paleness, or extreme fatigue. Contact your doctor as soon as possible.
• Increased levels of certain liver enzymes—transient elevation of transaminases (AST, ALT), lactate dehydrogenase, alkaline phosphatase.
• Renal failure, especially when certain medications are used concomitantly (aminoglycosides, diuretics), which could lead to abnormal blood test results (elevated creatinine and/or blood urea nitrogen levels).
• Exacerbation of myasthenia gravis (muscle disease).
• Serious neurological disorders known as encephalopathy (which could lead to confusion, altered consciousness, seizures, abnormal movements), particularly in cases of high doses or renal dysfunction (see sections 2 and 3).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or nurse, 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cefoxitin LDP-Laboratorios TORLAN

Keep the medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

After reconstitution:

Chemical and physical in-use stability has been demonstrated for 8 hours at 25°C and 2-8°C with water for injections. From a microbiological standpoint, the product should be used immediately. If not used immediately, the times and conditions of storage during use are the responsibility of the user.

After diluting the reconstituted solution with solvents:

Do not refrigerate.

Chemical and physical in-use stability has been demonstrated for 4 hours at 25°C.

From a microbiological standpoint, if the dilution method does not exclude the risk of microbial contamination, the product should be used immediately.

If not used immediately, the times and conditions of storage during use are the responsibility of the user.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cefoxitin LDP-Laboratorios TORLAN

-The active substance is sodium cefoxitin.

Each vial contains 1.0515 g of sodium cefoxitin equivalent to 1000 mg of cefoxitin.

Each vial contains 2.103 g of sodium cefoxitin equivalent to 2000 mg of cefoxitin.

Appearance of Cefoxitin LDP-Laboratorios TORLAN and contents of the pack

Cefoxitin LDP-Laboratorios TORLAN is a white or almost white powder.

Cefoxitin LDP-Laboratorios TORLAN is supplied in vials containing 1000 mg or 2000 mg of cefoxitin as the sodium salt, closed with a chlorobutyl rubber stopper and sealed with an aluminum cap with a polypropylene flip-off seal.

Cefoxitin LDP-Laboratorios TORLAN 1 g powder for solution for injection and for infusion EFG is available in packs of 1, 5, 10, 20, 25, 50 and 100 vials.

Cefoxitin LDP-Laboratorios TORLAN 2 g powder for solution for injection and for infusion EFG is available in packs of 1, 5, 10, 20, 25, 50 and 100 vials.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

LDP LABORATORIOS TORLAN, S.A.

Ctra de Barcelona, 135-B

08290 Cerdanyola del Vallés

Barcelona

Spain

Local Representative: Laphysan, SA
C/ Anabel Segura 11. Building A., 4th Floor, Door D
28108 Alcobendas
Madrid
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

France:

CEFOXITINE LDP-LABORATORIOS TORLAN 1 g, poudre pour solution injectable/pour perfusion

CEFOXITINE LDP-LABORATORIOS TORLAN 2 g, poudre pour solution injectable/pour perfusion

United Kingdom:

RENOXITIN 1 G POWDER FOR SOLUTION FOR INJECTION/ INFUSION

RENOXITIN 2 G POWDER FOR SOLUTION FOR INJECTION/ INFUSION

Date of latest revision of this leaflet: April 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) www.aemps.gob.es

MEDICAL ADVICE:

What should you know about antibiotics?

Antibiotics are effective against infections caused by bacteria and do not work against infections caused by viruses.

Your doctor has prescribed this antibiotic for you because it is appropriate for your specific condition and current illness.

Some bacteria have the ability to survive and reproduce despite the action of antibiotics. This phenomenon is known as resistance, which renders certain antibiotic treatments ineffective.

Resistance results from the abusive or inappropriate use of antibiotics.

You may promote the development of bacterial resistance, thereby delaying your recovery or even rendering the medication ineffective, if you do not:

• Take the prescribed dose.

• Take it exactly as prescribed.

• Complete the entire course of treatment.

Therefore, to preserve the effectiveness of this medication:

1. Do not use an antibiotic unless it has been prescribed by your doctor.
2. Take it exactly as prescribed.
3. Do not reuse an antibiotic without a prescription, even if you think you are treating a similar illness.
4. Never give your antibiotic to another person, as it may not be suitable for their condition.
5. Once your treatment is complete, return any unused medication in its original packaging to your pharmacist, so they can dispose of it properly and appropriately.

The following information is intended exclusively for healthcare professionals:

Preparation and administration of the reconstituted solution:

Cefoxitin may be reconstituted with 10 ml of water for injections. Immediately after reconstitution, this cefoxitin solution may be added to 40 ml of the following commonly used infusion solutions (1 g or 2 g in 50 ml of solution, corresponding to 20–40 mg/ml):

-0.9% Sodium Chloride,

-5% or 10% Glucose,

-Combined solution of 5% glucose and 0.9% sodium chloride,

-5% Glucose buffered with 0.02% sodium bicarbonate,

-5% Glucose supplemented with 0.2% or 0.45% saline solution,

-Ringer's lactate solution,

-Combined solution of 5% glucose and Ringer's lactate,

-Combined solution of 5% or 10% fructose in water for injections,

-10% Fructose in saline solution,

-M/6 Sodium lactate solution.

This medicinal product may be administered concomitantly with other antibiotics (by intravenous route using separate syringes or infusions).

When this medicinal product is administered simultaneously with other antibiotics, they must not be mixed in the same syringe or infusion.

Reconstitution

Cefoxitin LDP-Laboratorios TORLAN should be reconstituted with water for injections: 1 g is soluble in 2 ml.

Cefoxitin LDP-Laboratorios TORLAN is a highly soluble medicinal product; for intravenous use, it is preferable to dissolve both the 1 g and 2 g doses in 10 ml of water for injections. The solution should be shaken to dissolve the powder, and once mixed, the contents of the vial should be withdrawn using a syringe.

Dilution

The reconstituted solution should be diluted with the solvents mentioned in section 6.6: add approximately 40 ml of solvent to the reconstituted solution to achieve a total volume of 50 ml.

The product should be used immediately after reconstitution/dilution.

Disposal of unused medication and of all materials that have been in contact with it must be carried out in accordance with local regulations.