CEFEPIMA SALA 1 g POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

Introduction

Package Leaflet: Information for the User

Cefepima Sala 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, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Cefepima Sala and what is it used for
2. What you need to know before you start using Cefepima Sala
3. How to use Cefepima Sala
4. Possible side effects
5. Storage of Cefepima Sala
6. Contents of the pack and further information

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

Cefepima Sala contains the active substance cefepime.

Cefepime belongs to a group of antibiotics called cephalosporins, which work by killing bacteria.

Cefepime is used when an infection is known to be caused by bacteria that are sensitive to cefepime. It is used to treat the following infections:

• lung infections such as pneumonia,
• infections in the reproductive system (in adults), urinary tract, and kidneys,
• skin infections,
• abdominal infections,
• bloodstream infections caused by bacteria (bacteremia),
• infection in the brain and spinal cord in children (meningitis),
• infections in patients with a low white blood cell count (neutropenia)

2. What you need to know before you start using Cefepima Sala

Do not use Cefepima Sala

• if you are allergic to cefepime or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use cefepime:

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

Using cefepime with other medicines

Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because cefepime may affect the way other medicines work. Also, other medicines may affect the way cefepime works.

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

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

You should also tell your doctor or nurse if you are having blood glucose or blood tests.

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.

Driving and using machines

No studies have been done to know the effects on the ability to drive and use machines.

Do not drive or use machines unless you are sure that you are not affected.

3. How to use Cefepima Sala

A doctor or nurse will give you this medicine. You will be given it in one of the following ways:

• As an injection into a muscle (e.g., the arm muscle).
• By slow injection into one of your veins. This process can take between 3 and 5 minutes.
• Through a small tube in one of your veins. This is called intravenous infusion. It usually lasts at least 30 minutes.

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

Adults and elderly patients

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

Use in children and adolescents

The dose is calculated by the doctor based on 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, 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 given
• For children weighing more than 40 kg, the adult dose may be used
• The maximum dose in children should not exceed 2g 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 getting the dose you need.

If you use more Cefepima Sala than you should

If you think you have received too much Cefepima Sala, tell 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 medicine and the amount taken.

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

4. Possible side effects

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

Severe allergic reactions(rare, may affect up to 1 in 1,000 people)

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

Symptoms may include:

• sudden swelling of the face, throat, lips, and mouth. This can 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 (test for some blood problems)

Common:may affect up to 1 in 10 people

• problems with blood clotting. Symptoms include easy bruising
• anemia that can make you look pale, feel tired, and short of breath
• inflammation, pain, or burning sensation at the injection site
• diarrhea
• liver problems, such as jaundice and changes in liver enzymes in the blood
• rash

Uncommon:may affect up to 1 in 100 people

• yeast infection in the mouth
• 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
• hives, itching, and redness of the skin

- kidney problems (which can be seen in a blood test)

• fever

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

• fungal infections
• tingling and numbness in the body
• dizziness, with convulsions (seizures)
• difficulty breathing
• abdominal pain, constipation
• feeling cold and chills
• itching in the genitals

Frequency not known:the frequency cannot be calculated from the available data

• certain types of anemia (hemolytic or aplastic anemia)
• false positives in urine glucose tests
• 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 side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cefepima Sala

Your doctor or pharmacist is responsible for storing this medicine.

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 pack after EXP.

Unopened

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

After opening

The product should be used immediately after opening.

Reconstituted product

IM administration

Water for injections, 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 2 hours at 25 ± 5°C or for 24 hours at a temperature not above 2 to 8°C.

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

IV administration

Water for injections, sodium chloride 9 mg/ml (0.9%), and glucose 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 above 2 to 8°C.

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

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

6. Container Content and Additional Information

Cefepima Sala Composition

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

Product Appearance and Container Content

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

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

It is available in packs of 1 or 50 vials.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Laboratorio Reig Jofré, SA

Gran Capitan 10, 08970

Sant Joan Despí – Barcelona Spain

Manufacturer

Laboratorio Reig Jofré, S.A.

C/ Jarama, 111, Polígono industrial – 45007 Toledo Spain

Date of Last Revision of this Prospectus: May 2016

“Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (http://www.aemps.gob.es)<---------------------------------------------------------------------------------------------------------­

This information is intended only for healthcare professionals:

Cefepima Sala 1 g powder for solution for injection and infusion EFG

Posology and Method of Administration

It can be administered by intravenous and intramuscular routes

Intravenous administration is preferred in patients with severe or potentially life-threatening infections, especially when there is a risk of shock.

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 posology and method of 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 normally 7 to 10 days; however, longer treatment may be required for more severe infections. For empirical treatment of febrile neutropenia, the duration of treatment is normally 7 days or until resolution of neutropenia.

In patients with a body weight <40 kg, the pediatric dose is recommended.< p>

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 table below.

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 start of dialysis during a 3-hour dialysis session. In cases of continuous ambulatory peritoneal dialysis, cefepima may 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 48-hour intervals.

Elderly Patients

No dose adjustment is necessary in patients with normal renal function. However, it is recommended that the dose be adjusted for patients with renal insufficiency (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 recommended dose in children is:

Experience is limited with children under 2 months of age. Based on 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. The administration of cefepima in these patients should be carefully monitored.

For children >40 kg, the adult dosing guidelines apply. The pediatric dose should not exceed the maximum daily adult dose (2 g every 8 hours). Experience is limited regarding intramuscular injection in children.

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

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

The same dosing interval or dose reduction indicated for an adult with renal insufficiency is recommended.

Administration Instructions

Reconstitute before use.

Like other cephalosporins, after reconstitution, the solution may become slightly yellowish, but this does not mean that 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 injectable preparations or glucose 50 mg/ml (5%) solution for injectable preparations or sodium chloride 9 mg/ml (0.9%) solution,

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 container.

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

Intramuscular Administration:

Prepare the solution for IM administration using 1 g of Cefepima Sala diluted with 3 ml of water for injectable preparations or lidocaine hydrochloride 5 mg/ml (0.5%) solution or sodium chloride 9 mg/ml (0.9%) solution or glucose 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 bottle, or injection site is not used.

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

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

Incompatibilities

Cefepima Sala solutions 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

After Opening

The product should be used immediately after opening.

Reconstituted Product

IM Administration

Water for injectable preparations, 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 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 not administered immediately, the in-use storage conditions and times before administration are the responsibility of the user and normally should not exceed 24 hours at 2-8°C, unless the reconstitution/dilution has been carried out under controlled and validated aseptic conditions.

IV Administration

Water for injectable preparations, sodium chloride 9 mg/ml (0.9%), and glucose 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 not administered immediately, the in-use storage conditions and times before administration are the responsibility of the user and normally should not exceed 24 hours at 2-8°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.