Cefepime panpharma

Package leaflet: Information for the user

Cefepime Panpharma, 2 g, powder for solution for injection/infusion
Cefepime (as cefepime hydrochloride monohydrate)
Please read all of this leaflet carefully before this medicine is administered, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• Consult your doctor, pharmacist or nurse if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If any of the adverse effects worsen, or if you notice any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse.

Leaflet contents:

1. What Cefepime Panpharma is and what it is used for
2. What you need to know before using Cefepime Panpharma
3. How to use Cefepime Panpharma
4. Possible side effects
5. How to store Cefepime Panpharma
6. Contents of the pack and other information

1. What Cefepime Panpharma is and what it is used for

Cefepime Panpharma is an antibiotic presented as a powder for solution for injection or infusion. The active substance in this medicine, cefepime, belongs to a group of antibiotics known as cephalosporins. These antibiotics are closely related to penicillins.
This medicine is used to treat bacterial infections caused by organisms sensitive to cefepime.
This medicine is indicated for the treatment of the following infections:
Adults

• Sepsis (blood infection).
• Severe pneumonia.
• Complicated urinary tract infections.
• Intra-abdominal infections, including peritonitis, in combination with another antibiotic, if necessary.
• Biliary tract infections, including cholecystitis.
• Empiric treatment of febrile episodes of unknown cause in patients with impaired immune function [empiric treatment of febrile episodes in patients with moderate or severe neutropenia (i.e. a condition in which the number of white blood cells in the blood is reduced, associated with fever)] in combination with another antibiotic, if necessary.

Children

• Sepsis (blood infection).
• Severe pneumonia.
• Complicated urinary tract infections.
• Bacterial meningitis.
• Empiric treatment of febrile episodes of unknown cause in patients with impaired immune function [empiric treatment of febrile episodes in patients with moderate or severe neutropenia (i.e. a condition in which the number of white blood cells in the blood is reduced, associated with fever)] in combination with another antibiotic, if necessary.

2. Important information before using Cefepime Panpharma

When not to use Cefepime Panpharma

• If the patient is allergic to cefepime, any other antibiotic in the cephalosporin group, or to any of the other ingredients of this medicine (listed in section 6).
• If the patient has ever previously experienced an immediate and/or severe hypersensitivity reaction to penicillin or any other antibiotic with a similar chemical structure (beta-lactam antibiotic).

Warnings and precautions
Before starting treatment with Cefepime Panpharma, consult a doctor, pharmacist, or nurse.
When to exercise special caution with Cefepime Panpharma

• If the patient has kidney disease (e.g. impaired kidney function has been diagnosed), as elimination of this medicine from the body may be reduced.
• If the patient suffers from allergies (e.g. hay fever, urticaria) or has previously experienced an allergic reaction to medicines. If any hypersensitivity reaction occurs, administration of Cefepime Panpharma must be discontinued and appropriate treatment initiated.
• If the patient develops persistent diarrhoea during or after treatment with this medicine. In such a case, the doctor should be informed immediately so that it can be determined whether the diarrhoea is due to antibiotic-associated colitis; treatment with this medicine may need to be discontinued.

Use of Cefepime Panpharma may lead to the development of secondary infections caused by other microorganisms (e.g. mucosal infections caused by fungi, which manifest as redness of mucous membranes or white coating on them). These secondary infections will be appropriately treated by a doctor.
Children
Special dosage guidelines apply to infants and children (see section 3 titled "How to use Cefepime Panpharma").
Elderly patients
Dosage in elderly patients should be carefully adjusted, taking into account renal function, as this patient group has a higher likelihood of kidney disease (see section 3 titled "How to use Cefepime Panpharma").
Other medicines and Cefepime Panpharma
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use, including those obtained without a prescription.
Pregnancy and breastfeeding
During pregnancy, breastfeeding, if pregnancy is suspected, or when planning pregnancy, consult a doctor or pharmacist before using this medicine.
Do not use this medicine during pregnancy unless absolutely necessary and explicitly recommended by a doctor.
Cefepime may pass into breast milk; therefore, this medicine should be used during breastfeeding only with great caution and after discussing this issue with a doctor.
Before starting any medicine, consult a doctor or pharmacist for advice.
Driving and operating machinery
Do not drive or operate machinery during treatment with medicines such as Cefepime Panpharma, as disturbances in consciousness or dizziness may occur in the patient.

3. How to use Cefepime Panpharma

This medicine should always be taken as directed by a doctor or pharmacist. If in
doubt, consult a doctor or pharmacist.
Dosage in patients with normal kidney function
Adults and children weighing at least 40 kg (in children, this corresponds approximately to an age of 12 years)

Treatment usually lasts 7 to 10 days. Cefepime Panpharma should not be administered for less than 7 days or longer than 14 days within a single treatment cycle.
In cases of fever episodes in patients with impaired immune system function (neutropenia), treatment should last for 7 days or until resolution of neutropenia.
Children over 1 month of age whose body weight does not exceed 40 kg (approximately corresponding to age 12 years)
Single dose of Cefepime Panpharma [mg/kg body weight] / interval between doses / duration of treatment

In children aged 1 to 2 months, a dose of 30 mg/kg body weight administered every 12 or
8 hours is sufficient. Children in this age group should be carefully monitored during treatment
with this medicinal product.
In children whose body weight exceeds 40 kg, the dose recommended for adults should be used (see
table). In children over 12 years of age and with body weight below 40 kg, the dose recommended
for younger patients weighing 40 kg should be used. The dose used in children should not exceed
the maximum dose recommended for adults (2.0 g every 8 hours).
Dosage in patients with impaired renal function
Adults and children with body weight at least 40 kg (in children this corresponds approximately to
the age of 12 years)
Cefepime Panpharma is eliminated from the body mainly via the kidneys. If the patient has kidney disease
(e.g. impaired renal function has been diagnosed), the physician will reduce the dose of this
drug to adjust for the slowed elimination of the drug by the kidneys. The initial dose of Cefepime Panpharma in patients with mild or moderate renal impairment is the same as in patients with normal renal function, i.e. 2.0 g.
The table below provides information on recommended maintenance doses (subsequent doses).

Patients undergoing dialysis therapy
If a patient requires dialysis (hemodialysis), they will receive a reduced dose:

• 1.0 g of Cefepime Panpharma on the first day of treatment, followed by 0.5 g of Cefepime Panpharma per day in subsequent days of treatment for all types of infections, except for febrile conditions in patients with impaired immune function (neutropenia). In the latter case, the dose is 1.0 g per day.

Whenever possible, Cefepime Panpharma should be administered at the same time each day, and on days when dialysis is performed, it should be given after dialysis is completed.
In patients with impaired renal function undergoing continuous peritoneal dialysis, the following dosing regimen is recommended:

• 1.0 g of Cefepime Panpharma every 48 hours in cases of severe infections [sepsis (blood infection), pneumonia, complicated urinary tract infections, gallbladder and biliary tract infections].
• 2.0 g of Cefepime Panpharma every 48 hours in cases of very severe infections [intra-abdominal infections, including peritonitis, febrile conditions in patients with impaired immune function (neutropenia)].

Children from 1 month of age whose body weight does not exceed 40 kg (approximately corresponding to
12 years of age)
A single dose of 50 mg/kg body weight in children aged 2 months to 12 years, and a single dose of 30 mg/kg body weight in children aged 1 to 2 months corresponds to the 2.0 g dose in adults. Therefore, the same prolongation of the interval between doses and/or the same dose reduction as in adults is recommended, according to the tables shown below.
Children from 2 months of age whose body weight does not exceed 40 kg (approximately corresponding to
12 years of age)

Infants aged 1 to 2 months

Liver function disorders
There is no need to adjust the dosage in patients with impaired liver function.
Elderly patients
Dosage in elderly patients should be carefully selected, taking into account renal function, as this patient group has a higher probability of developing kidney disease.
Further information on the use of this medicinal product is provided at the end of this leaflet in the section intended for physicians and other healthcare professionals.
Administration of a higher than recommended dose of Cefepime Panpharma
Contact your doctor or another healthcare professional immediately, as more severe adverse reactions may occur in some circumstances.
Missed dose of Cefepime Panpharma
Contact your doctor or another healthcare professional immediately.
Discontinuation of treatment with Cefepime Panpharma
Do not stop using this medicinal product without first consulting your doctor. The condition may worsen if treatment with Cefepime Panpharma is discontinued before the recommended treatment period is completed.
If you have any further questions regarding the use of this medicinal product, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You must immediately inform your doctor if any of the following symptoms occur in the patient:

• Severe allergic reaction associated with sudden and severe shortness of breath, swelling of the face or other parts of the body, skin rash, circulatory disturbances and drop in blood pressure.
• Sudden appearance of skin rash, blisters or skin peeling accompanied by fever.
• Persistent diarrhoea ranging from mild to severe intensity with abdominal pain and fever, which may occur even up to two months after completion of antibiotic therapy.
• Disturbances of consciousness with disorientation, hallucinations, stiffness, fainting, muscle tremors, painful muscle spasms.

When assessing adverse reactions, the following frequency classification is used:

• Very common: occurs in more than 1 in 10 patients
• Common: occurs in 1 to 10 in 100 patients
• Uncommon: occurs in 1 to 10 in 1,000 patients
• Rare: occurs in 1 to 10 in 10,000 patients
• Very rare: occurs in less than 1 in 10,000 patients
• Not known: frequency cannot be estimated from available data

Very common adverse reactions (occurring in more than 1 in 10 patients)

• Positive Coombs test (a test measuring levels of certain antibodies).

Common adverse reactions (occurring in 1 to 10 in 100 patients)

• Prolonged blood clotting time (prolonged prothrombin time or activated partial thromboplastin time),
• Anaemia,
• Increased number of certain blood cells (eosinophilia),
• Phlebitis at the infusion site,
• Diarrhoea,
• Rash,
• Reaction at the infusion site,
• Pain and inflammatory reaction at the injection site,
• Increased levels of certain substances in the blood (alanine aminotransferase, aspartate aminotransferase, bilirubin, alkaline phosphatase).

Uncommon adverse reactions (occurring in 1 to 10 in 1,000 patients)

• Fungal infection of the mouth with white coating,
• Vaginitis,
• Decreased number of certain blood cells (thrombocytopenia, leukopenia, neutropenia),
• Headache,
• Colitis with abdominal pain,
• Nausea,
• Vomiting,
• Skin redness (erythema),
• Urticaria,
• Itching of the skin,
• Increased blood urea levels,
• Increased serum creatinine levels,
• Fever,
• Inflammatory reaction around the infusion site.

Rare adverse reactions (occurring in 1 to 10 in 10,000 patients)

• Fungal infections (candidiasis),
• Allergic reactions,
• Seizures,
• Sensory disturbances, e.g. tingling and numbness (paraesthesiae),
• Taste disturbances,
• Dizziness,
• Vasodilation,
• Dyspnoea,
• Abdominal pain,
• Constipation,
• Fluid retention in tissues (oedema),
• Joint pain,
• Genital itching,
• Chills,
• Ringing in the ears (tinnitus).

Other adverse reactions (frequency cannot be estimated from available data)

• Decreased number of certain blood cells [aplastic anaemia, pathological breakdown of red blood cells (haemolytic anaemia), agranulocytosis and resulting increased risk of bleeding, bruising and infections],
• Life-threatening shock caused by an allergic reaction (see introduction to this section on adverse reactions),
• False positive urine glucose test,
• Disorientation,
• Hallucinations,
• Coma,
• Numbness,
• Non-inflammatory brain disease (encephalopathy),
• Disturbances of consciousness,
• Muscle tremors,
• Bleeding,
• Gastrointestinal disorders,
• Skin cell necrosis (toxic epidermal necrolysis),
• Severe inflammatory skin redness with blisters and fever (Stevens-Johnson syndrome, see introduction to this section on adverse reactions),
• Inflammatory skin redness (erythema multiforme),
• Renal failure,
• Kidney damage (toxic nephropathy).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the "national reporting system":
Department of Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Cefepime Panpharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and container following the term EXP. The expiry date refers to the last day of the specified month.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Cefepime Panpharma contains

• The active substance is cefepime hydrochloride monohydrate. Each vial of Cefepime Panpharma 2 g contains 2 g of cefepime (as cefepime hydrochloride monohydrate).
• The other ingredient is L-arginine.

What Cefepime Panpharma looks like and contents of the pack
Cefepime Panpharma 2 g is a pale yellow powder for solution for injection/infusion in a glass vial made of colourless glass (type II) with a capacity of 50 ml, closed with a chlorobutyl rubber stopper, aluminium seal and a polipropylene flip-off cap. The vials are packed in cardboard boxes.
Pack sizes: 10 vials.
Marketing Authorisation Holder and Manufacturer
PANMEDICA
406 BUREAUX DE LA COLLINE
92213 SAINT-CLOUD CEDEX
FRANCE
Manufacturer
LDP-LABORATORIOS TORLAN S.A.
CTRA DE BARCELONA, 135-B
08290 CERDANYOLA DEL VALLES
BARCELONA
SPAIN
This medicinal product is authorised in the member states of the European Economic Area under the following names:

Information intended exclusively for healthcare professionals:

Data on resistance to cefepime – see the technical information for the medicinal product
Cefepime Panpharma.
How to use:
Preparation and administration of the ready-to-use solution:
The medicinal product Cefepime Panpharma, powder for solution for injection/infusion, should be reconstituted:
a) with water for injections
or with one of the intravenous infusion solutions listed in point b) below
b) 0.9% sodium chloride solution
0.9% sodium chloride solution with 5% glucose solution
5% or 10% glucose solution
lactated Ringer's solution
lactated Ringer's solution with 5% glucose solution
1/6 molar sodium lactate solution
The volume of solvent to be added to each vial and the concentration of cefepime in the vial are given in the table below.

Reconstituted solutions prepared with water for injections maintain physical and chemical stability for 18 hours at room temperature (15–25°C) and for 2 days if stored refrigerated (2–8°C).
Reconstituted solutions prepared with other diluents (0.9% sodium chloride solution, 0.9% sodium chloride solution with 5% glucose solution, 5% or 10% glucose solution, Ringer's solution with lactates, Ringer's solution with lactates and 5% glucose solution, 1/6 molar sodium lactate solution) maintain physical and chemical stability for 4 hours at room temperature (15–25°C).
From a microbiological standpoint, the product should be used immediately. If not used immediately, the responsibility for storage conditions and duration after dilution lies with the user, provided that the storage time after reconstitution does not normally exceed 24 hours at 2–8°C, unless the product has been reconstituted under controlled and validated aseptic conditions.
Note!
Properly prepared ready-to-use solutions may have a yellow to yellowish-brown coloration. This does not affect the efficacy of the medicinal product Cefepime Panpharma. The contents of the vial are intended for single use only. Any unused portion of the ready-to-use solution must be discarded.