Prospecto: information for the patient

Cefepima Qilu 1gpolvo for injectable solution and for EFG perfusion

cefepima

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, pharmacist, or nurse.

-If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section4.

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

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

3.How to use Cefepima Qilu

4.Possible adverse effects

5.Storage of Cefepima Qilu

6.Contents of the package and additional information

Cefepima Qilu contains the active ingredient cefepime (in the form of cefepime dihydrochloride monohydrate), which is an antibiotic that belongs to the group of cephalosporins. This type of antibiotic acts in a similar way to penicillin.

This medication is used to treat the following infections caused by pathogens sensitive to cefepime:

Adults

• Blood infection due to one of the infections listed here.
• Acute pneumonia.
• Complicated urinary tract infections.
• Abdominal cavity infections, including peritonitis (infection of the lining that covers the inner wall of the abdomen), if necessary, in combination with another antibiotic.
• Bile duct and gallbladder infections.
• Unknown fever episodes in patients with weakened immune systems, if necessary, in combination with another antibiotic.

Children

• Blood infection due to one of the infections listed here.
• Acute pneumonia.
• Complicated urinary tract infections.
• Bacterial meningitis.
• Unknown fever episodes in patients with weakened immune systems, if necessary, in combination with another antibiotic.

Do not use CefepimaQilu:

-If you are allergic to cefepima or any of the other components of this medication (listed in section6).

-If you are allergic to the class of antibiotics known as cephalosporins or to other similar antibiotics (beta-lactam antibiotics, such as penicillins, monobactam antibiotics, or carbapenem antibiotics).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Cefepima Qilu.

Be especially cautious:

-If you have kidney failure, as this will affect the excretion of cefepima.

-If you have any allergies (e.g., pollen, hay fever) and have had previous allergies to beta-lactam antibiotics (penicillins, monobactam antibiotics, or carbapenem antibiotics) or other medications. If you experience an allergic reaction during treatment with cefepima,póngase en contacto con su médico inmediatamente, as it could have serious consequences. In this case, your doctor will immediately stop your treatment.

-If you have ever had asthma or are prone to allergic reactions.

-If you are to undergo blood or urine tests. It is essential to inform your doctor that you are receiving Cefepima Qilu, as this medication may affect the results of some tests.

-If you have persistent diarrhea while receiving Cefepima Qilu or after treatment. Inform your doctor about this, as they will investigate whether the antibiotic treatment has caused inflammation of the intestinal walls and, if necessary, take appropriate measures to treat it.

The treatment with Cefepima Qilu may cause secondary infections with other pathogens (e.g., fungal infection of the mucous membranes, with redness and white deposits on the mucous membranes). Your doctor will treat these secondary infections accordingly.

Children

In the case of infants and children, special administration guidelines should be applied (see section3).

Older patients

In older patients, the dosage should be carefully chosen and taking into account the activity of the kidneys, as the likelihood of reduced kidney activity is higher (see section3).

Use of CefepimaQilu with other medications

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

Pregnancy and breastfeeding

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

Pregnancy

Cefepima Qilu should not be administered during pregnancy, unless strictly necessary.

Breastfeeding

Cefepima is excreted in breast milk, so Cefepima Qilu should only be administered during breastfeeding after carefully reviewing the benefits and risks.

Driving and operating machinery

Do not drive or use tools or machines, as treatment with Cefepima Qilu may cause effects such as altered consciousness, dizziness, confusion, or hallucinations.

The doctor must use Cefepima Qilu in accordance with the information provided below or the information contained in the Technical Data Sheet or Summary of Product Characteristics. If you have any doubts, consult your doctor or pharmacist.

Dosage in patients with normal renal function:

Adults and children over 40 kg of body weight (around 12 years):

The duration of treatment is usually 7 to 10 days. In general, Cefepima Qilu should be used for at least 7 days and a maximum of 14 days per treatment. When treating recurrent fever in patients with deficient defenses against infections (neutropenia), the usual duration of treatment is 7 days or until the neutropenia has improved.

Children 1 month to 40 kg of body weight (around 12 years):

In the case of children 1-2 months of age, a dose of 30 mg/kg of body weight every 12 or 8 hours is sufficient. Children of this age should be closely monitored during administration.

In the case of children with a body weight of more than 40 kg, the adult dosage recommendation should be applied (see previous table). In the case of children 12 years of age with a body weight of less than 40 kg, the dosage recommendations for younger patients with a body weight of ≤ 40 kg should be applied. The dose in children should not exceed the adult maximum dose (2 g every 8 hours).

Dosage in patients with renal insufficiency:

Adults and children with a body weight of 40 kg or more (around 12 years):

If you have renal insufficiency, the dose should be adjusted to counteract the slower excretion through the kidneys. The first dose of patients with mild to moderate renal insufficiency is the same as that of patients with normal renal function, i.e., 2 g of cefepima.

The following tables show the subsequent dosage recommendations (maintenance dose):

Patients on dialysis:

If you need hemodialysis, you will receive a lower dose:

- 1 g of cefepima on the first day of treatment and, from then on, 500 mg of cefepima/day on subsequent days, except in the case of recurrent fever in patients with deficient defenses against infections (neutropenia). In this case, the dose is 1 g/day.

Cefepima should be administered at the same time every day, and on dialysis days, it should be administered after completing dialysis.

In patients with renal insufficiency receiving continuous peritoneal dialysis (peritoneal dialysis), the following dosage recommendation is recommended:

- 1 g of cefepima every 48 hours in the case ofsevere infections(blood infection, pneumonia, complicated urinary tract infections, cholecystitis and biliary tract infections).

- 2 g of cefepima every 48 hours in the case ofvery severe infections(abdominal cavity infections, including peritonitis, recurrent fever in patients with deficient defenses against infections (neutropenia).

Children 1 month to 40 kg of body weight (around 12 years):

A dose of 50 mg/kg of body weight in the case of children 2 months to 12 years of age or a dose of 30 mg/kg of body weight in the case of children 1-2 months of age, which is equivalent to an adult dose of 2 g.

Therefore, the same prolongation of the dosing interval or reduction of the dose as in adults is recommended, according to the following tables.

Children 2 months of age to 40 kg of body weight (around 12 years):

Infants 1-2 months:

Administration form:

These solutions can be administered by slow intravenous injection (3-5 minutes) with a syringe or by intravenous infusion.

If you want more information, see the sectionThis information is intended only for healthcare professionalsat the end of this prospectus.

Using more Cefepima Qilu than you should:

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

Missing a dose of Cefepima Qilu:

Inform your doctor immediately.

Stopping treatment with Cefepima Qilu:

If you stop receiving Cefepima Qilu too soon, the underlying disease you have may worsen.

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

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

If you experience any of the following serious side effects, inform your doctor immediately:

• severe allergic reaction, associated with sudden and progressive difficulty breathing, swelling of the head and body region, skin rash, circulatory disorders, low blood pressure
• sudden appearance of severe skin rash, blisters, or peeling, accompanied by fever (Stevens-Johnson syndrome)
• persistent diarrhea, ranging from mild to severe, accompanied by abdominal pain and fever, which may occur during antibiotic treatment or up to two months after treatment
• altered consciousness, accompanied by confusion, hallucinations, physical rigidity, loss of consciousness, muscle spasms, and seizures

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

• positive result in the Coombs test (a method to determine antibodies)

Common(may affect up to 1 in 10people)

• prolonged blood clotting time (prolongation of prothrombin time and partial thromboplastin time)
• anemia
• increased count of certain blood cells (eosinophilia)
• inflammation of blood vessel walls at the infusion site
• diarrhea
• skin rash
• irritation at the infusion site
• pain and inflammation at the injection site
• increased levels of certain blood values (alanine aminotransferase, aspartate aminotransferase, bilirubin, alkaline phosphatase)

Uncommon(may affect up to 1 in 100people)

• oral fungal infection, accompanied by white deposits
• vaginal inflammation
• reduction in certain blood cells (thrombocytopenia, leukopenia, neutropenia)
• headache
• inflammation of the colon, accompanied by abdominal pain (colitis)
• nausea
• vomiting
• skin redness (erythema)
• hives (urticaria)
• itching on the skin
• increased urea nitrogen in blood
• increased creatinine in serum
• fever
• inflammation at the infusion site

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

• unspecified fungal infection
• allergic reaction, seizures (crisis)
• strange sensations on the skin, such as tingling or numbness (paresthesia)
• alterations in taste
• dizziness
• dilation of blood vessels
• difficulty breathing
• abdominal pain
• constipation
• fluid accumulation in tissues (edema)
• joint pain
• itching in the genital area
• chills
• tinnitus in the ears (acufenos)

Frequency unknown(cannot be estimated from available data)

• reduction in certain blood cells (aplastic anemia), increase in red blood cell rupture (hemolytic anemia)
• agranulocytosis (low white blood cell count), which increases the risk of bleeding, hematomas, and infection
• swelling (angioedema)
• false positive glucose in urine
• confusion
• hallucinations
• coma
• torpor
• non-inflammatory brain disease (encephalopathy)
• alteration of knowledge
• muscle twitching
• bleeding
• gastrointestinal disorders
• death of skin cells (toxic epidermal necrolysis)
• inflammatory skin redness (erythema multiforme)
• renal failure
• renal disease (toxic nephropathy)

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 the Pharmacovigilance of Medicines for Human Use: 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 box and vial after «CAD». The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Store in the original packaging to protect it from light.

Reconstituted Solution

Physical and chemical stability has been demonstrated in use for 2hours at a temperature of 25°C and for 6hours at 2-8°C.

From a microbiological point of view, the drug should be used immediately, unless the opening and reconstitution method avoids the risk of microbiological contamination.

If not used immediately, the observation of time and conservation conditions during use are the responsibility of the healthcare professional in charge of the treatment.

Diluted Solution

Physical and chemical stability has been demonstrated in use for 2hours at a temperature of 25°C and for 6hours at 2-8°C when cefepima is mixed with solutions of amikacin, clindamycin, heparin, potassium chloride, theophylline, peritoneal dialysis, and parenteral nutrition.

From a microbiological point of view, the drug should be used immediately, unless the opening and reconstitution method avoids the risk of microbiological contamination.

If not used immediately, the observation of time and conservation conditions during use are the responsibility of the healthcare professional in charge of the treatment.

Medications should not be thrown down the drain or in the trash. Dispose of the containers and medications you no longer need at the SIGRE point of the pharmacy or in any other medication waste collection system. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of CefepimaQilu

The active ingredient is cefepima.

Cefepima Qilu 1 g contains 1 g of cefepima (in the form of cefepima dihydrochloride monohydrate).

The other components are: arginine.

Appearance of Cefepima Qilu and contents of the packaging

Cefepima Qilu is a white to light yellow powder for injection and infusion. Cefepima Qilu is presented in glass vials of 1, 10 and 50 vials, closed with a butyl rubber stopper covered with a 20 mm film and sealed with a combined aluminum and plastic cap.

Marketing Authorization Holder

QILU PHARMA SPAIN S.L.

Paseo de la Castellana 40, 8th floor, 28046-Madrid, Spain

Local Representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55, 08007 – Barcelona, Spain

Responsible for manufacturing

KYMOS, S.L.

Ronda de Can Fatjó, 7B (Parque Tecnológico del Vallès), Cerdanyola del Vallès, 08290 Barcelona, Spain

MIAS Pharma Limited

Suite 2, Stafford House, Strand Road, Portmarnock, Co. Dublin, Ireland

Tillomed Malta Ltd.

Malta Life Sciences Park, LS2.01.06 Industrial Estate, San Gwann, SGN 3000, Malta

Malta

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

Last review date of this leaflet: October 2022

The detailed and updated information on this medicinal product is available on 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 healthcare professionals:

If you want more information about theresistance datato cefepima, consult the Technical Dossier or Summary of Characteristics of Cefepima Qilu.

Administration form:

Preparation and administration of the ready-to-use solution for intravenous (IV) use:

The powder must be dissolved in:

a)Water for injection or one of the intravenous solutions listed in section b):

b)Sodium chloride 0.9% solution (9 mg/ml).

Sodium chloride 0.9% solution (9 mg/ml) with glucose 5% (50 mg/ml).

Glucose 5% (50 mg/ml) or glucose 10% (100 mg/ml) solution.

Lactate sodium solution.

Solution of lactate sodium with glucose 5% (50 mg/ml).

Lactate sodium 1/6 M solution.

The volume of the solvent to be added to the corresponding vial and the resulting cefepima concentration are shown in the following table:

These solutions must be used immediately as a slow intravenous injection (3-5 minutes) with a syringe or intravenous infusion.

Alternatively, it can be added to one of the infusion solutions listed in section b), administered as a brief intravenous infusion over a period of around 30 minutes.

Cefepima must not be mixed with other medications or solutions that are not listed above in sections a) and b).

Compatibility (miscibility):

Cefepima can be administered intravenously simultaneously with other antibiotics that are not amicacina and clindamicina (in which compatibility has been demonstrated; see below), but must not be administered mixed with cefepima or through the same intravenous route (see section 6.2).

The following table shows which medications and solutions are compatible with cefepima (that can be mixed) and under what conditions the infusion solution can be stored (temperature, period):

The mixtures of cefepima with amicacina, clindamicina, heparina, cloruro potásico, teofilina, peritoneal dialysis solution and parenteral nutrition solution are physically and chemically stable at room temperature (25 °C) for 2 hours and in the refrigerator (2-8 °C) for 6 hours.

However, regardless of the physical and chemical stability shown, given the possible microbial contamination of the preparation, the solution in question must be prepared again in a short period of time before administration, whenever possible. If this is not possible, the ready-to-use solution must be stored in a refrigerator (2-8 °C) for a maximum of 6 hours.

Information on the use of the ready-to-use solution.

Note:

The ready-to-use solutions prepared following the instructions may acquire a yellowish color to yellowish brown. This is not a sign of loss of cefepima efficacy.

The contents of a vial are intended for single use. Any remaining solution must be discarded.

The ready-to-use solution must be visually inspected before administration for the presence of particulate matter. If particulate matter is observed, the solution must not be used.

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