Prospect: information for the user

Cefepima Sala 1g 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 questions, consult your doctor, pharmacist, or nurse.

- If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

1. What is Cefepima Sala and for what it is used

2. What you need to know before starting to use Cefepima Sala

3. How to use Cefepima Sala

4. Possible adverse effects

5. Storage of Cefepima Sala

6. Contents of the package and additional information

Cefepima Sala contains the active ingredient cefepima.

Cefepima belongs to a group of antibiotics called cephalosporins, which act by eliminating bacteria.

Cefepima is used when an infection is known to be caused by bacteria sensitive to cefepima. It is used in the treatment of the following infections:

• Pulmonary infections such as pneumonia,
• Reproductive tract infections (in adults), urinary tract and kidney infections,
• Skin infections,
• Abdominal infections,
• Bloodstream infections caused by bacteria (bacteremia),
• Brain and spinal cord infection in children (meningitis),
• Infections in patients with decreased white blood cells (neutropenia)

Do not use Cefepima Sala

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use cefepima:

• If you have kidney problems.
• If you are allergic to something not mentioned in this prospectus.
• If you have ever had intestinal problems, particularly colitis (inflammation of the intestine).
• If you are an elderly patient.

Use of cefepima with other medications

Inform your doctor or nurse if you are taking, have taken recently, or may need to take any other medication. This includes medications obtained without a prescription and herbal medications. This is because cefepima may affect the functioning of other medications. Other medications may also affect the functioning of cefepima.

In particular, inform your doctor or nurse if you are taking any of the following medications:

• Aminoglycosides or other antibiotics (used to treat infections)
• Anticoagulants (medications to thin the blood)

You should also inform your doctor or nurse if you are undergoing glucose or blood tests.

Pregnancy and breastfeeding

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

Driving and operating machinery

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

Do not drive or operate machinery unless you are sure it will not affect you.

A doctor or nurse will administer this medication. It will be administered in one of the following ways:

• As an injection into a muscle (for example, the arm muscle).
• By slow injection into one of your veins. This process may take between 3 and 5 minutes.
• Through a small tube in one of your veins. This is called intravenous infusion. Generally, the duration is at least 30 minutes.

Cefepima Sala will usually be administered for 7-10 days, depending on the type of infection you have.

Adults and elderly patients

The usual dose is 500 mg (milligrams) to 1 g (gram) every 12 hours. If you have a severe infection, the doctor may give you a higher dose, up to 2 g every 8 hours.

Use in children and adolescents

The dose is calculated by the doctor based on your body weight.

• In children over 2 months and weighing less than 40 kg, the usual dose is 50 mg per kg of body weight every 12 hours. Depending on the type and severity of the infection, the doses may be given every 8 hours.
• In children under 2 months, a dose of 30 mg per kg of body weight every 12 hours may be administered.
• For children weighing more than 40 kg, the adult dose may be used.
• The maximum dose in children should not exceed 2 g every 8 hours.

Patients with kidney problems

If you have kidney problems, you will be given a lower dose. You may need to have blood tests to check that you are receiving the right dose.

If you use more Cefepima Sala than you should

If you think you have received too much Cefepima Sala, inform your doctor or nurse.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

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

Severe allergic reactions(rare, may affect fewer than 1 in 1,000 people)

If you have a severe allergic reaction,inform your doctor immediately.

The symptoms may include:

- Sudden swelling of the face, throat, lips, and mouth. This may make it difficult to breathe or swallow.

- Sudden swelling of the hands, feet, and ankles.

Other possible side effects:

Very common:may affect more than 1 in 10 people

- Positive Coombs test results (analysis for some blood problems)

Common:may affect up to 1 in 10 people

- Blood clotting problems. Symptoms include easy bruising

- Anemia that may make you look pale, feel tired, and short of breath

- Inflammation, pain, or burning sensation at the injection site

- Diarrhea

- Liver problems, for example, jaundice and changes in liver enzymes in blood

- Rash

Uncommon:may affect up to 1 in 100 people

- Oral thrush infection

- Vaginal infections

- Changes in the number of white blood cells in your blood. Symptoms include a sudden rise in body temperature (fever), chills, and sore throat

- Headache

- Inflammation of the large intestine (colon). Symptoms include diarrhea, usually with blood and mucus, stomach pain, and fever

- Nausea and vomiting

- Urticaria, itching sensation, and skin redness

- Kidney problems (which may be seen in a blood test)

- Fever

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

- Fungal infections

- Pinpricks and tingling sensation in the body

- Dizziness, with convulsions

- Difficulty breathing

- Abdominal pain, constipation

- Feeling cold and chills

- Genital itching

Unknown frequency:the frequency cannot be calculated from the available data

- Some types of anemia (hemolytic anemia or aplastic anemia)

- False positives in urine glucose analysis

- Confusion, hallucinations

- Loss of consciousness, brain disorders

- Kidney problems

- Severe skin rash with ulcers in the mouth, joint pain, and eye pain

Reporting of side effects

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

Your doctor or pharmacist is responsible for the storage of this medication.

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.

Unopened

No special storage conditions are required. Store the vial in the outer packaging to protect it from light.

Once opened

The product must be used immediately after opening.

Reconstituted product

IM Administration

Sterile water for injection, sodium chloride 9 mg/ml (0.9%), glucose 50 mg/ml (5%) and

lidocaine 5 mg/ml (0.5%)

Chemical and physical stability has been demonstrated for use during 2 hours at 25± 5°C or during 24 hours at a temperature not exceeding 2 to 8°C.

From a microbiological standpoint, the product must be administered immediately. If not administered immediately, storage conditions and times in use, before use, are the responsibility of the user and should normally not exceed 24 hours at

2 – 8 ºC, unless reconstitution / dilution has been performed under controlled and validated aseptic conditions.

IV Administration

Sterile water for injection, sodium chloride 9 mg/ml (0.9%) and glucose 50 mg/ml (5%)

Chemical and physical stability has been demonstrated for use during 2 hours at 25± 5°C or during 24 hours at a temperature not exceeding 2 to 8°C.

From a microbiological standpoint, the product must be administered immediately. If not administered immediately, storage conditions and times in use, before use, are the responsibility of the user and should normally not exceed 24 hours at

2 – 8 ºC, unless reconstitution / dilution has been performed under controlled and validated aseptic conditions.

Medications should not be disposed of through the drains or trash. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

Composition of Cefepima Sala

• The active principle is cefepima (as dihydrochloride monohydrate).
• Each vial contains 1g of cefepima (as dihydrochloride monohydrate).
• The other components are: arginine.

Aspect of the product and contents of the package

Cefepima Sala is a powder. It is white to pale yellow in color.

It is packaged in a transparent Type I glass vial of 20 ml, closed with a bromobutyl rubber stopper and an aluminum flip-off cap.

It is presented in containers with 1 or 50 vials.

Not all package sizes may be marketed.

Marketing Authorization Holder

Laboratorio Reig Jofré, SA

Gran Capitan 10, 08970

Sant Joan Despí – Barcelona Spain

Responsible for Manufacturing

Laboratorio Reig Jofré, S.A.

C/ Jarama, 111, Industrial Estate – 45007 Toledo Spain

Last review date of this leaflet: May 2016

“The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (http://www.aemps.gob.es)<---------------------------------------------------------------------------------------------------------­

This information is intended solely for healthcare professionals:

Cefepima Sala 1 g powder for injection and for infusion EFG

Dosage and administration

It can be administered by intravenous and intramuscular routes.

It is preferable to administer intravenously in patients with severe or potentially life-threatening infections, especially when shock is possible.

It must be reconstituted before administration. The reconstituted solution is white or slightly yellowish. The solution must be clear and free of visible particles.

The dosage and administration of cefepima vary depending on the nature and severity of the infection, the sensitivity of the microorganism, renal function, and the patient's general condition.

Adults with normal renal function

According to the following table:

The duration of treatment is usually 7 to 10 days; however, a longer treatment may be required for more severe infections. For the empirical treatment of febrile neutropenia, the duration of treatment is usually 7 days or until neutropenia resolves.

In patients with a body weight <40

Adults with renal impairment

The dose of cefepima should be adjusted to compensate for the reduced renal elimination rate. In adult patients with mild to moderate renal impairment, the recommended initial dose of cefepima should be the same as that for patients with normal renal function. The recommended maintenance dose should be according to the instructions in the following table.

To estimate creatinine clearance, the following formula (Gault and Cockcroft) can be used only when serum creatinine is available. Serum creatinine should represent a stable state of renal function:

Men: Creatinine clearance (ml/min) = Weight (kg) x (140 – age)

72 x serum creatinine (mg/dl)

Women: 0.85 x value calculated using the formula for men

Patients on dialysis

If hemodialysis is performed, approximately 68% of the total amount of cefepima will be eliminated at the beginning of dialysis during a 3-hour dialysis session. In cases of continuous ambulatory peritoneal dialysis, cefepima can be administered at the usual recommended doses for patients with normal renal function, i.e., 500 mg, 1 g, or 2 g, depending on the severity of the infection, but only at intervals of 48 hours.

Geriatric patients

No dose adjustment is necessary in patients with normal renal function. However, it is recommended that the dose be adjusted in patients with renal impairment (see sections 4.4 and 5.1).

Patients with hepatic impairment

No dose adjustment is necessary in patients with hepatic insufficiency (see section 5.1).

Pediatric population

Children with normal renal function

The usual recommended dose in children is:

The experience is limited in children under 2 months of age. Based on the data obtained in the > 2 months age group, it is recommended, based on a pharmacokinetic model, that for children between 1 and 2 months of age, doses of 30 mg/kg every 12 hours or every 8 hours should be administered. Cefepima administration in these patients should be carefully monitored.

For children > 40 kg, the adult dosing guidelines should be applied. The pediatric dose should not exceed the maximum daily dose for adults (2 g every 8 hours). The experience is limited with regard to intramuscular injection in children.

In children, the main route of elimination of cefepima is renal and urinary excretion; the dose should be adjusted in children with renal impairment.

A dose of 50 mg/kg (children between 2 months and 12 years of age) and a dose of 30 mg/kg (children between 1 and 2 months) are comparable to doses of 2 g in adults.

The same interval between doses or the same dose reduction indicated for an adult with renal impairment should be recommended.

Administration instructions

Reconstitute before use.

Like other cephalosporins, after reconstitution, the solution may become slightly yellowish, but this does not mean there is a loss of activity.

The solution should only be used if it is transparent and free of particles.

Intravenous administration:

In IV administration, Cefepima Sala should be reconstituted with 10 ml of water for injection or glucose solution 50 mg/ml (5%) or sodium chloride solution 9 mg/ml (0.9%).

Injection

The prepared solution is injected slowly over a period of 3 to 5 minutes- either directly into a vein or directly into the cannula of an infusion system.

Infusion

For IV infusion, the powder is dissolved as described for direct IV injections. An appropriate amount of the prepared solution is added to an infusion bag.

The solution should be administered over a period of approximately 30 minutes.

Intramuscular administration:

Prepare the solution for IM administration by dissolving 1 g of Cefepima Sala with 3 ml of water for injection or lidocaine hydrochloride solution 5 mg/ml (0.5%) or sodium chloride solution 9 mg/ml (0.9%) or glucose solution 50 mg/ml (5%):

The following table contains the instructions for reconstitution:

Cefepima Sala can be administered simultaneously with other antibiotics or other medications, provided that the same syringe, infusion bag, or injection site is not used.

Like other cephalosporins, after reconstitution, the solution may become slightly yellowish, but this does not mean there is a loss of activity. The solution should only be used if it is transparent and free of particles.

The elimination of unused medication and all materials that have come into contact with it should be carried out in accordance with local regulations.

Incompatibilities

Solutions of Cefepima Sala should not be mixed with the following antibiotics: metronidazole, vancomycin, gentamicin, tobramycin, and netilmicin, as physical or chemical incompatibilities may occur. If concomitant therapy is indicated, these agents should be administered separately.

Shelf life

Unopened

3 years

Once opened

The product should be used immediately after opening.

Reconstituted product

IM administration

Water for injection, sodium chloride solution 9 mg/ml (0.9%), glucose solution 50 mg/ml (5%), and

lidocaine hydrochloride solution 5 mg/ml (0.5%)

Chemical and physical stability has been demonstrated for 2 hours at 25± 5°C or for 24 hours at a temperature not exceeding 2 to 8°C.

From a microbiological point of view, the product should be administered immediately. If it is not administered immediately, the storage conditions and times in use, before use, are the responsibility of the user and should not normally exceed 24 hours at 2 to 8°C, unless the reconstitution/dilution has been carried out under controlled and validated aseptic conditions.

IV administration

Water for injection, sodium chloride solution 9 mg/ml (0.9%), and glucose solution 50 mg/ml (5%)

Chemical and physical stability has been demonstrated for 2 hours at 25± 5°C or for 24 hours at a temperature not exceeding 2 to 8°C.

From a microbiological point of view, the product should be administered immediately. If it is not administered immediately, the storage conditions and times in use, before use, are the responsibility of the user and should not normally exceed 24 hours at 2 to 8°C, unless the reconstitution/dilution has been carried out under controlled and validated aseptic conditions.

No special storage conditions are required. Store the vial in the outer packaging to protect it from light.