Prospect: information for the user

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

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 doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

Cefepima LDP-Laboratorios TORLAN is indicated for the treatment of infections caused by bacteria susceptible to cefepima, namely:

-lower respiratory tract infections, including nosocomial pneumonia and community-acquired pneumonia, acute exacerbation of chronic bronchitis and secondary bacterial infection of acute bronchitis;

• uncomplicated and complicated urinary tract infections, including pyelonephritis;

• skin and subcutaneous tissue infection;
• intra-abdominal infection, including peritonitis and biliary tract infections;
• gynecological infections;
• bacterial meningitis in infants and children;
• in combination with other antibacterial agents in the treatment of neutropenic patients with fever suspected to be due to bacterial infection;

Consideration should be given to the official guidelines on the appropriate use of antibacterial agents

Do not use Cefepima LDP-Laboratorios TORLAN:

• if you are allergic to cefepime, any other cephalosporin, or any other type of antibiotic, or to any of the other components of this medication (listed in section 6).
• if you have a history of severe allergic reaction to any other type of beta-lactam antibiotics (penicillins, monobactams, and carbapenems).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Cefepima LDP-Laboratorios TORLAN.

Special care should be taken when using Cefepima LDP-Laboratorios TORLAN:

• Severe allergic reactions, including occasional fatal outcomes, have been reported. Inform your doctor if you have a history of asthma or allergic reactions (skin rash, itching ...). Severe allergic reactions may require epinephrine and other supportive therapy.
• Cefepime is not suitable for the treatment of certain types of infections. Your doctor prescribed this antibiotic because it is the best option for your condition.
• if you have kidney problems (such as reduced renal function) since the elimination of this medication may be affected.
• if you have persistent diarrhea during or after using this medication. Inform your doctor immediately so that they can investigate whether the diarrhea is the result of intestinal inflammation caused by the antibiotic; treatment with this medication may need to be suspended.
• If you have allergies (such as hay fever, urticaria) or have had an allergic reaction to medications in the past.

Cefepime should be discontinued in the event of any type of hypersensitivity reaction, and appropriate therapeutic measures should be initiated.

• Doses for elderly patients should be carefully selected and take into account renal function, as there is a greater possibility of developing renal disease.

Use of Cefepima with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those obtained without a prescription.

Renal function should be closely monitored when Cefepima LDP-Laboratorios TORLAN is combined with medications that can affect the kidneys (such as aminoglycosides and potent diuretics).

Cephalosporins may potentiate the effect of coumarin anticoagulants.

Interaction with diagnostic tests

Cefepime may produce a false positive reaction in some laboratory tests (Coombs test and urine glucose results).

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not use this medication during pregnancy, unless it is absolutely necessary and specifically indicated by your doctor. If you become pregnant during treatment with Cefepima LDP-Laboratorios TORLAN, consult your doctor.

Cefepime LDP-Laboratorios TORLAN may be transferred to breast milk, therefore, this medication should be used during breastfeeding with great caution and only after consulting your doctor.

Driving and operating machinery

No studies have been conducted to determine the effects on the ability to drive and operate machinery.

However, you may experience altered consciousness, dizziness, confusion, or hallucinations, which may affect your ability to drive or operate machinery.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Cefepima LDP-Laboratorios TORLAN can be administered via intravenous or intramuscular route.

After reconstitution, the solution is yellow to yellow-brown in color.

The usual dose and administration route vary according to the severity of the infection, renal function, and the patient's general condition.

The IV route is preferred in patients with severe infections or in a life-threatening situation, particularly if there is a possibility of shock.

Recommended dosage for adults and children (> 12 years) weighing > 40 kg with normal renal function:

The usual duration of therapy is 7 to 10 days. However, more severe infections may require longer treatment. For empirical treatment of febrile neutropenia, the usual duration of therapy is 7 days or until resolution of neutropenia.

In patients weighing ≤ 40 kg, the recommended dosage for children is suggested.

Use in children

In children with normal renal function:

The usual recommended dose is:

• Pneumonia, urinary tract infection, skin and subcutaneous tissue infection:
• • Children over 2 months and weighing ≤ 40 kg: 50 mg/kg every 12 hours for 10 days; in more severe infections, an interval of 8 hours between doses should be used.
• Bacteremia occurring in association with infections, bacterial meningitis, and empirical treatment of febrile neutropenia:
• • Children over 2 months and weighing ≤ 40 kg: 50 mg/kg every 8 hours for 7 to 10 days.

Experience in children under 2 months is limited. Administration of Cefepima LDP-Laboratorios TORLAN in this age group should be closely monitored.

In children weighing > 40 kg, the recommended dosage for adults should be used.

Do not exceed the maximum recommended adult dose (2 g every 8 hours). Experience with intramuscular use in children is limited.

Patients with advanced age, patients with renal dysfunction, patients on dialysis, and children with renal dysfunction:

The doctor will determine the dose to be administered.

If you use more Cefepima LDP-Laboratorios TORLAN than you should:

Contact your doctor or other healthcare professionals immediately, as you may experience more severe side effects in certain situations.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Cefepima LDP-Laboratorios TORLAN may present one or more of the following side effects:

Very common(may affect more than 1 in 10 people):

• Positive Coombs test results without hemodialysis (method for determining antibody levels)

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

• Increased blood coagulation time (increased prothrombin or thromboplastin time);
• Anemia;
• Elevated levels of certain blood cells (eosinophilia);
• Phlebitis at the infusion site;
• Diarrhea;
• Rashes;

• Reaction at the infusion site;
• Pain and inflammation at the injection or infusion site;
• Increased levels of bilirubin and certain enzymes (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase).

Uncommon(may affect up to 1 in 100 people)

• Oral candidiasis (fungal infection of the mouth with white coating);
• Vaginal infection;
• Reduced levels of certain blood cells (thrombocytopenia, leucopenia, neutropenia)
• Headache;
• Colitis (inflammation of the large intestine);
• Pseudomembranous colitis;
• Nausea;
• Vomiting;
• Redness of the skin (erythema);
• Urticaria;
• Pruritus;
• High blood urea;
• High serum creatinine;
• Fever;
• Inflammation of the infusion area.

Rare(may affect 1 in 1,000 people):

• Fungal infections (candidiasis);
• Allergic reactions;
• Angioedema (sudden swelling of the skin, subcutaneous tissue, mucosa, or submucosa);
• Seizures;
• Pruritus or numbness;
• Alteration of taste;
• Dizziness;
• vasodilation;
• Difficulty breathing;
• Abdominal pain;
• Constipation;
• Itching in the genital organs;
• Chills.

Unknown frequency(unknown frequency)

• Aplastic anemia, hemolytic anemia, and agranulocytosis;
• Confusion;
• Hallucinations;
• Coma;
• Drowsiness;
• Cerebral encephalopathy (non-inflammatory brain disease)
• Altered consciousness;
• Muscle spasms;
• Bleeding;
• Gastrointestinal disease;
• Severe skin reactions (such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme);
• Renal insufficiency;
• Toxic nephropathy (renal damage);
• False-positive result for urine glucose test.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special temperature conditions for conservation. Store the packaging in the outer packaging.

Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains or in the trash.

. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

Composition of Cefepime LDP-Laboratorios TORLAN

• The active ingredient is cefepime dihydrochloride monohydrate.

Each vial of Cefepime LDP-Laboratorios TORLAN 2g powder for injectable solution and for infusion, contains 2g of cefepime (as dihydrochloride monohydrate).

• The other components are: L-arginine.

Appearance of Cefepime LDP-Laboratorios TORLAN and contents of the package

Cefepime LDP-Laboratorios TORLAN 2g is a white to pale yellow powder for injectable solution/infusion, packaged in a 50 ml glass vial closed with a flip-off cap. The vials are packaged in cardboard boxes.

Presentations: 1, 5, 10, 20, 25, 50 and 100 vials.

Only some package sizes may be marketed.

Marketing Authorization Holder

LDP LABORATORIOS TORLAN, S.A.

Ctra de Barcelona, 135-B

08290 Cerdanyola del Valles

Barcelona

Spain

Responsible for Manufacturing:

LDP LABORATORIOS TORLAN, S.A.

Ctra de Barcelona, 135-B

08290 Cerdanyola del Valles

Barcelona

Spain

Local Representative

LAPHYSAN, SAU

C/ Anabel Segura nº11. Edificio A, Planta 4, puerta D

28108 Alcobendas

Madrid

Spain

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

Portugal: Cefepime LDP Laboratorios TORLAN

Belgium: Cefepime LDP-Laboratorios TORLAN 1000 mg | 2000 mg, Powder for solution injectable/pour perfusion

United Kingdom: Renapime 1g | 2g, Powder for solution for injection/infusion

Last review date of this leaflet: November 2017

For detailed and updated information on this medicinal product, please consult 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 medical professionals or healthcare professionals:

The disposal of unused medicinal product and of all materials that have been in contact with it, will be carried out in accordance with local regulations.

Preparation and administration of the reconstituted solution:

Cefepime LDP-Laboratorios TORLAN, powder for injectable solution and for infusion must be dissolved in:

1. water for injection

or in one of the solutions listed in section b) below for intravenous administration

b)sodium chloride 0.9%,

sodium chloride 0.9%, with glucose 5% solution

glucose 5% solution or 10% solution

Ringer Lactate solution

Ringer Lactate solution, with glucose 5% solution

lactate sodium 1/6 M solution

For intravenous injection,the volume of the diluent to be added to each vial and the resulting cefepime concentration are presented in the following table:

For intravenous infusion, the volume of the infusion diluent to be used for reconstitution and the resulting cefepime concentration are presented in the following table:

The volume of the infusion diluent to be used for each vial and the resulting cefepime concentration are presented in the following table:

The resulting solution must be administered over approximately 30 minutes.

For intramuscular administrationreconstitutethe 1g vial with 3.0 ml of water for injection.

Nota:

The reconstituted solutions, which are prepared correctly, may present a yellow to brown yellow color. This does not mean that the efficacy of Cefepime LDP-Laboratorios TORLAN may be compromised.

The contents of the vial are intended for single use. The remaining reconstituted solution must be discarded.

Inspect the vial before use. Only use if the solution does not contain particles.