CEFEPIMA LDP- LABORATORIOS TORLAN 1 g POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

Introduction

Package Leaflet: Information for the User

Cefepime LDP-Laboratorios TORLAN 1g powder for solution for injection and infusion EFG

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

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

1. What is Cefepime and what is it used for

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

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

• skin and subcutaneous tissue infections;
• intra-abdominal infections, 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 a bacterial infection;
• treatment of patients with bacteremia that occurs in association with, or is suspected to be associated with, any of the aforementioned infections.

• Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or 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 medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

The official guidelines on the appropriate use of antibacterial agents should be considered.

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

Do not use Cefepime 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 medicine (listed in section 6).
• if you have a history of severe allergic reaction to any other type of beta-lactam antibiotic (penicillins, monobactams, and carbapenems).

Warnings and precautions

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

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

• Severe and occasionally fatal allergic reactions 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 has prescribed this antibiotic because it is the best option for your disease.
• if you have kidney problems (such as reduced renal function) as the elimination of this medicine may be affected.
• if you have persistent diarrhea during or after using this medicine. Inform your doctor immediately so that they can investigate whether the diarrhea is the result of intestinal inflammation caused by the use of the antibiotic; treatment with this medicine may need to be suspended.
• If you have allergies (such as hay fever, hives) or have had an allergic reaction to medicines 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 chosen carefully and should take into account renal function, as there is a greater possibility of developing kidney disease.

Using Cefepime with other medicines

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

Renal function should be carefully monitored when Cefepime LDP-Laboratorios TORLAN is combined with medicines that may affect the kidneys (such as aminoglycosides and potent diuretics).

Cephalosporins may enhance the effect of coumarin anticoagulants.

Interaction with diagnostic tests

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

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

Driving and using machines

No studies have been conducted to determine the effects on the ability to drive and use machines.

However, you may experience altered state of consciousness, dizziness, confusion, or hallucinations, which may affect your ability to drive or use machines.

3. How to use Cefepime LDP-Laboratorios TORLAN

Follow exactly the administration instructions of this medicine as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Cefepime LDP-Laboratorios TORLAN can be administered by intravenous or intramuscular route.

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

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

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

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

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

In patients with a weight ≤ 40 kg, the recommended dosage is indicated for children.

Use in children

In children with normal renal function:

The 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, the dosing interval should be 8 hours.
• Bacteremia that occurs 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 Cefepime LDP-Laboratorios TORLAN in children of this age should be carefully monitored.

In children weighing > 40 kg, the recommended dose is the same as for adults.

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

Elderly patients, patients with renal impairment, patients on dialysis, and children with renal impairment:

The doctor will determine the dose to be administered.

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

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

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

4. Possible side effects

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

Cefepime LDP-Laboratorios TORLAN may cause 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;
• rash;

• 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 fungal infections with white coating (oral candidiasis);
• vaginal infection;
• reduced levels of certain blood cells (thrombocytopenia, leukopenia, neutropenia)
• headache;
• colitis (inflammation of the large intestine);
• pseudomembranous colitis;
• nausea;
• vomiting;
• erythema (redness of the skin);
• urticaria;
• tingling;
• elevated blood urea;
• elevated serum creatinine;
• fever;
• inflammation of the infusion area.

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

• fungal infections (candidiasis);
• allergic reactions;
• angioedema (sudden swelling of the skin, subcutaneous tissue, mucosa, or submucosa);
• seizures;
• tingling or numbness;
• altered sense of taste;
• dizziness;
• vasodilation;
• difficulty breathing;
• abdominal pain;
• constipation;
• genital itching;
• chills.

Frequency not known(frequency not known)

• aplastic anemia, hemolytic anemia, and agranulocytosis;
• confusion;
• hallucinations;
• coma;
• somnolence;
• encephalopathy (non-inflammatory brain disease)
• altered consciousness;
• myoclonus (muscle spasms);
• bleeding;
• gastrointestinal disease;
• severe skin reactions (such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme);
• renal failure;
• toxic nephropathy (kidney damage);
• false positive result for glucose in urine test.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cefepime LDP-Laboratorios TORLAN

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

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

This medicine does not require special temperature storage conditions. Store the container in the outer packaging. Do not use this medicine if you notice visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste.

If you are unsure, ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Container Content and Additional Information

Composition of Cefepima LDP-Laboratorios TORLAN

• The active ingredient is cefepime dihydrochloride monohydrate.

Each vial of Cefepima LDP-Laboratorios TORLAN 1g powder for solution for injection and infusion contains 1g of cefepime (as dihydrochloride monohydrate).

• The other components are: L-arginine.

Appearance of Cefepima LDP-Laboratorios TORLAN and Container Content

Cefepima LDP-Laboratorios TORLAN 1g is a white to pale yellow powder for solution for injection/infusion, packaged in a 20 ml glass vial closed with a flip-off cap. The vials are packaged in cardboard boxes.

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

Only some package sizes may be marketed.

Marketing Authorization Holder

LDPLABORATORIOS TORLAN,S.A.

Ctra de Barcelona, 135-B

08290 Cerdanyola del Valles

Barcelona

Spain

Manufacturer

LDPLABORATORIOS 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: Cefepima LDP Laboratorios TORLAN

Belgium: Cefepime LDP-Laboratorios TORLAN 1000 mg | 2000 mg, Powder for solution for injection/infusion

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

Date of the last revision of this prospectus: November 2017

Detailed and updated 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/

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This information is intended only for doctors or healthcare professionals:

The disposal of unused medicinal products and all materials that have come into contact with them must be carried out in accordance with local regulations.

Preparation and administration of the reconstituted solution:

Cefepima LDP-Laboratorios TORLAN, powder for solution for injection and infusion, must be dissolved in:

1. water for injection

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

• sodium chloride 0.9% solution,

sodium chloride 0.9% with 5% glucose solution

5% or 10% glucose solution

Ringer's Lactate solution

Ringer's Lactate solution with 5% glucose solution

1/6 M sodium lactate solution.

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

For intravenous infusion,the volume of infusion diluent (solution listed in section b)) to be used for reconstitution and the resulting concentration of cefepime are presented in the following table:

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

The resulting solution should be administered over approximately 30 minutes.

For intramuscular administrationreconstitute the 1g vial with 3.0 ml of water for injectable preparations.

Note:

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

The content of the vial is intended for single use. The remaining reconstituted solution must be discarded.

Inspect the vial before use. It can only be used if the solution does not present particles.